Hadcorp News: April 26, 2008




Germany Bans Children From Getting Cosmetic Surgery

eMaxHealth.com

Hickory, NC , USA

Cosmetic surgery has been banned for children and adolescents in
Germany . The ban on cosmetic surgery was announced on Wednesday
that will stop the tens of thousands of German youth going under the
knife in the name of beauty.


"Wishing for a breast job after finishing high school is no longer
the exception," wrote the bill's 30 parliamentary co-sponsors.


Children as young as 10 have become caught up in the cosmetic
surgery craze. The Federation of Pediatricians are also very
concerned about the number of young children who are having body
piercings and permanent tattoos. Some of the members of NDR are also
calling for a ban of those procedures.


The German Society for Cosmetic and Plastic Surgery is
understandably upset by the ban. They say that the numbers have been
exaggerated and have "nothing to do with reality." They also contend
that often the operations are medically necessary.


"If you (lawmakers) knew how thankful 14 to 16 year-old patients are
after these procedures, that would put your worries in context,"
Joachim Graf von Finkenstein, head of DCAEPC, said.

Plastic surgery for the very young who have not finished growing
seems to be a little drastic. Boob jobs can wait until a child is an
adult and can be sure that they honestly wish to deal with all the
risks that are involved.



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STEM CELL RESEARCH AND TECHNOLOGY



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Rearming America :The military's plan to regrow body parts


By William Saletan

Posted Friday, April 18, 2008, at 12:40 PM ET

The regeneration of lost body parts has just moved from science
fiction to U.S. military policy.


Yesterday the Department of Defense announced the creation of the
Armed Forces Institute of Regenerative Medicine, which will go by
the happy acronym AFIRM. According to DOD's news service, AFIRM
will "harness stem cell research and technology … to reconstruct new
skin, muscles and tendons, and even ears, noses and fingers." The
government is budgeting $250 million in public and private money for
the project's first five years. NIH and three universities will be
on the team.

The people who brought you the Internet are about to bring you
replacement fingers.


If you've been following Human Nature for the past three years, you
know that tissue regeneration is well underway. The military has
been working on regrowing lost body parts using extracellular
matrices. Scientists in labs have grown blood vessels, livers,
bladders, breast implants, and meat. This year they announced the
production of beating, disembodied rat hearts. At yesterday's press
conference, Army Surgeon General Eric Schoomaker explained that our
bodies systematically generate liver cells and bone marrow and that
this ability can be redirected through "the right kind of
stimulation."

Now that the regeneration fantasy is becoming real, it's worth
pausing to notice how we're absorbing it culturally. This is
extremely freaky stuff. Just a few days ago, my wife and I were
explaining to our 5-year-old daughter that she needs to take good
care of her adult teeth because they're the last real teeth she'll
ever have.


That's just not true anymore. It's not true of her fingers and toes,
either. And why stop there? Schoomaker points out that salamanders
can regenerate whole limbs. He asks: "Why can't a mammal do the same
thing?"


When technology transforms humanity in such a fundamental way, it's
best to start with a context that feels normal. Today, that context
is what every American politician now calls "our brave men and women
in uniform." The wars in Iraq and Afghanistan , waged in large part
through improvised explosive devices, have produced nearly 1,000
U.S. military amputees.

Many other service members have lost eyesight or suffered burns or
spinal-cord damage. We all want to help these young people recover.
We've seen inspiring stories of doctors outfitting them with
prosthetic limbs. If only we could make them truly whole again. And
now we can.
At the press conference, Schoomaker displayed pictures of a wounded
Marine whose disfigured features could be restored only through
tissue regrowth. He vowed to "redefine the Army and military
medicine." The Defense Department's assistant secretary for health
declared a goal of "getting these people up to where they are
functioning and reintegrated, employed, [and] able to help their
families and be fully participating members of society."


It's a familiar and worthy goal. And it has to be, because in the
larger context of human history, its job is to ease us across the
mind-blowing threshold of human regeneration. If my daughter loses a
tooth, she may be able to grow it back. If my son loses a finger,
the work pioneered by AFIRM early in his life may be able to help
him.


Warfare will never be the same again, either. American military
medicine is already saving the lives of soldiers who would have died
in previous conflicts. Yesterday's death is today's wound. Now we're
raising the ante: Today's permanent wound will be tomorrow's bad
memory. Blow off our fingers, and we'll grow them back.


Further down the road, other possibilities will emerge. If we can
restore a soldier's original muscle strength, we can probably add to
it. The military is already encouraging soldiers to get LASIK, which
improves some people's eyesight beyond 20/20. It's hard to believe
we won't continue to improve that surgery and systematize it across
the armed forces. Most of us civilians will face these revolutions
when we're ready. By then, like AFIRM, they'll already be here.


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MEDICAL DEVICE NEWS


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Lawyer sued for not filing medical malpractice papers against
urologist

New York Daily News

New York, NY , USA

BY JOHN MARZULLI

DAILY NEWS STAFF WRITER

Monday, April 21st 2008, 4:00 AM

A Great Neck lawyer is being sued for failing to file court papers
in time to sue a urologist who allegedly botched a penile implant
procedure.
The suit, filed in Brooklyn Federal Court, accuses Ira Podlofsky, of
the law firm Podlofsky, Hill, Orange & Modzelewski, of missing the
deadline to file a medical malpractice action against the doctor.

Podlofsky and his firm "failed to commence a lawsuit and negligently
allowed the statute of limitations to expire," according to the
complaint filed by Christopher Isabella, who is back to being
impotent - and powerlessto recover damages from the doctor.

Isabella, a carpenter formerly of Maspeth, Queens, claims he
suffered serious injuries in 2004 when the doctor who installed the
penile prosthesis failed to remove a foreign device during the
surgery.

"It was a bonehead mistake," Isabella's new lawyer Peter Gordon said
about the doctor's flub.


The doctor, whose name is not given in the new lawsuit, initially
denied anything was wrong and referred Isabella to a psychologist,
telling him the problem was all in his mind, Gordon said.

"He's very bitter at the doctor," Gordon said of Isabella.

Finally, surgery to remove the device was performed, and Isabella
retained Podlofsky in July 2005, which gave the attorney a six-month
window to sue, Gordon contends.

But on March 6, 2007 - with the deadline already past - Podlofsky
sent the following letter to Isabella: "After due reflection, we are
going to decline to accept your case into our office."

"I don't know how he [Podlofsky] missed this one. It's a slam-dunk
case," Gordon said.

Isabella is seeking $10 million in damages from the lawyer for legal
malpractice.

Isabella and his wife, Natasha, now live in Michigan with the child
they were able to conceive when the implant was working.

Podlofsky declined to comment on the suit, and his attorney could
not be reached for comment.



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Service to mankind or medicine for profit

By Shan Juan (China Daily)
Updated: 2008-04-23 08:06


Are multinational pharmaceutical companies doing mankind a favor by
conducting clinical trials (on humans) or are they using Chinese
people as guinea pigs to make more money? The question came to the
fore again with a court hearing on a medical dispute in Beijing last
week.


Ouyang Lidong, 36, of Hunan province, was admitted to Beijing You'an
Hospital in 2006. Doctors diagnosed he had complicated liver
problems and only a liver transplant could save his life. Since a
donor liver was not immediately available, the hospital doctors
recommended on Dec 5, 2006, that he be put on extracorporeal liver
assist device (ELAD), or an artificial liver. Developed and
manufactured by Vital Therapies Inc., California, the ELAD is
designed to help liver failure patients survive till a donor liver
is available or another mode of treatment is found, says the US Food
and Drug Administration (FDA) website. The device, however, has not
been approved for use in the US.

Ouyang was part of a free trial program, and his wife He Binying
accepted the offer in a desperate bid to save his life. But he soon
developed complications, including rising blood sugar levels,
breathing problems and hemoptysis (coughing up of blood from the
respiratory tract that indicates a severe infection of the bronchi
or lungs), which proved fatal.

But before that - in fact, as soon as he developed the new
complications - his wife requested the doctors to put him off the
ELAD. Her requests went unheeded till Dec 7. And by the time the
therapy was stopped, Ouyang's condition had deteriorated. He was
transferred to the intensive care unit (ICU) later, and died on Dec
27, 2006.

A few days after his death, He Binying filed a lawsuit against the
hospital, alleging that its doctors' negligence had caused the death
of her husband. "Before we signed the paper giving consent for the
use of the ELAD, the hospital authorities had promised to stop the
therapy as soon as any adverse effect or discomfort was detected.
They had insisted it was very safe, too," she says.

"They made the wrong recommendation for the ELAD trial, which is
more suitable for acute liver failure, whereas my husband had been
suffering from hepatitis B for 12 years." Worse, they broke their
promise and continued the trial despite his worsening condition, she
says.

The hospital lawyer, on the other hand, argued in court last week
that the couple had signed the consent form before the trial, and
knew full well the efficacy of and potential risks associated with
the ELAD. "That should be enough to exempt the hospital from any
legal liability," he said.

Also, Ouyang's condition was serious, and the doctors had diagnosed
that he had been suffering from the life-threatening
hepatocirrhosis, and the only known cure was a liver transplant. "It
was natural for the hospital to have recommended the therapy to
prolong his life so he could get a donor liver," the lawyer said.

A Beijing Youth Daily report on June 19, 2007, quoted hospital Vice-
President Duan Zhongping, who also heads the institution's
Artificial Liver Treatment & Training Center, as having said that
before putting Ouyang on the ELAD, the doctors had tried it on 28
other patients and none had died.

Vital Therapies Inc. announced on Jan 4, 2007, that it had received
positive response for its clinical trials on the first 45 patients
at Beijing You'an and 302 Military hospitals. "Our center has
treated a large number of patients with other mechanical and bio-
artificial liver therapies, and although the data for ELAD are
preliminary, none has looked more promising than ELAD to impact a
patient's long-term survival from a single treatment," Duan said in
the announcement.

Ouyang's case does not seem to have changed the course of ELAD
treatment, for the center has said it would continue with the trials
till 90 consenting patients undergo the therapy. The center insists,
too, that no significant harmful effects have been attributed to the
ELAD, and has not posted any details of Ouyang's case. "The ELAD
trials in our hospital have been approved and commissioned by
China's State Food and Drug Administration (SFDA), which is
authorized to approve and oversee clinical trials in the country,"
Duan said. But according to the paper, SFDA's Medical Device
Department official Hu Xueyan denied that Duan had said so


Other experts too do not agree with Duan. "It's unethical to conduct
clinical trials in China without the SFDA's approval," says Qiu
Zongren of Asian Ethics Committee, which helps oversee such
schemes. "Trial patients should be well informed of potential
hazards and effects of the tests."

"Some foreign pharmaceutical companies and domestic medical
institutions just take advantage of regulatory loopholes to conduct
clinical trials for their products on innocent Chinese patients
because the cost involved (in China) is very low," said SFDA Deputy
Director Zhang Jingli said at a workshop organized by the
administration in Beijing early this month. To plug such loopholes,
he said the agency will issue a sound set of laws and regulations on
medical device management.

Duan has a supporter in breast cancer specialist Jiang Zefei, of
Beijing-based Military 307 Hospital, though. Jiang says global drug
trials have given Chinese patients a new hope, especially because
many of them are poor. It is not rare for poor patients to forego
treatment because of the high costs involved and the "not-so-
perfect" public healthcare system in China.

"Since 1997, hundreds of my critically ill patients have
participated in trials for different drugs to combat breast cancer,"
Jiang says. "Nearly all of them, I should say, have benefited from
the trials." Given the strict regulations on clinical trials, sudden
field inspections by the drug watchdog and the self-discipline
practiced by the hospital, there has been no medical dispute over
any of "my department's trials", he says.

"Medical ethics is the top concern in a drug trial Most of the
therapies would fail for terminal cancer patients. But clinical
trials of the latest potential remedies, provided free, might be
effective for them. At least, they can save the patients and their
families from the heavy economic burden even if they don't prove
efficacious," he says.

An increasing number of foreign drug and medical device companies
have begun outsourcing their research and development (R&D) work in
China, and clinical trials are on top of their tasks. China attracts
them with its sound infrastructure, low research cost and the huge
number of patients suffering from chronic and infectious diseases.
Experts say the cost of drug trials in China can be as little as one-
tenth of that in the US or Europe.

In the US, drug companies have a hard time trying to enroll enough
people for clinical trials. But the situation is quite different in
China, which has 130 million hepatitis B patients and carriers
alone - a number larger than the combined populations of Britain and
France. And many of such patients are poor farmers or workers.

"The US has no such pool," says Terry E. Winters, British biochemist
and chairman of the Vital Therapies Inc. Besides, foreign companies'
drugs and medical devices have to be tested locally in China before
they can enter the country's huge market, "That boosts trial
outsourcing too," he said.

Big drug companies doubled their investment in R&D to $2.2 billion
in China and India, and most of the additional amount came to China.
Drug companies' business is booming, and with it have increased
medical disputes, including those over clinical trials. Some of
these cases, like Ouyang's, end up in court, and verdicts in such
cases are slow to come by, given the series of complicated medical
verifications and appraisals.

Clinical trials for more than 800 new medications, including drugs
and medical devices, are conducted in the country every year,
according to official figures, and most of them are conducted by
foreign pharmaceutical companies.

Clinical trials can indeed be a problem - not only of medical
ethics, but also of proper healthcare, poverty and helpless
patients' desperation. And only foolproof government regulation and
socially conscious drug companies can make them beneficial to human
beings.



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MORE MEDICAL DEVICE NEWS


SEC says Tampa firm lied about medical device

Shareholder Class Action Filed Against Candela Corporation by the
Law Firm of Schiffrin Barroway Topaz & Kessler, LLP


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MERCURY


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Dental Fillings: Old School vs. New School

PR-USA.net

Varna, Bulgaria


More dentists are moving away from silver fillings because of health
and aesthetic concerns, finds a recent Wealthy Dentist survey. A
number no longer offer amalgam, preferring composite restorations
instead.

Dentists have used dental amalgam to make metal fillings for a long
time, but the material is more controversial now than ever before.
Some worry the silver/mercury alloy may cause health problems, while
others think it's still superior to tooth-colored composite
fillings.

When dentists were asked about amalgam restorations in a recent
Wealthy Dentist survey, 66% said they tell patients that they have
other cosmetic dentistry options. Another 22% tell patients about
potentially safer options; many of these dentists no longer use any
amalgams at all. However, 12% say they prefer placing amalgams.

Dental amalgam is an alloy of mercury, silver, and other metals. The
FDA says amalgam is safe, but some disagree. The primary alternative
is composite, a tooth-colored resin.

The poll also revealed that most dentists refer to amalgam
restorations as "silver fillings." However, there are many different
terms in use (not all of which are considered scientifically
neutral): mercury fillings, amalgam fillings, silver/mercury
fillings, silver amalgam, or mercury amalgam.

Lots of dentists think mercury fillings are perfectly safe. "I have
40 year old silver in my mouth and no concerns whatever," offered an
Oregon dentist. "Mercury poison causes mercury poison symptoms. To
my knowledge amalgam fillings never have. They try to blame amalgams
on every disease under the sun. Why do people without fillings get
the same diseases?" asked a Kentucky dentist.

Amalgam is seen as an old-fashioned material by many. "It was an
excellent material for 90 years, but more biocompatible materials
are now available," declared a Georgia pediatric dentist. "At least
a half a dozen countries in Europe have now done away with amalgam.
Don't kid yourself; we are just a stone's throw in the US from the
same ruling," warned a Colorado dentist.

Some dentists prefer amalgam because of its superior
longevity. "They last much longer than composite... It is a travesty
to not offer amalgams at all," declared a Canadian dentist.

Dental amalgam is most often used to restore back teeth, where its
metal color is less visible. "Next to gold inlays/onlays, amalgam
fillings are the longest lasting and sturdiest posterior
restorations that exist," said a Virginia dentist.

In addition, amalgam is a lot more affordable than gold (or even
composite). "It's a safe, cost-effective restoration," said a New
York dentist. "If it's banned, the cost of dentistry would increase
and the poor would be the most to suffer."

Since mercury is a known toxin, some recommend caution. "Why should
we have raw mercury in our offices?" asked a California dentist. "If
there is a spill you need a Haz Mat team to clean it up and a risk
to the staff with possible legal consequences." A Connecticut
dentist added, "Remember smoking used to be a great thing too!"

A few dentists recommend patients with amalgam fillings get them all
replaced, but many feel it's unethical to overstate the danger. "It
is malpractice to tell the average patient who has no allergies to
the components in amalgam that these restorations are a threat to
their health. Patients have a right to a choice, but that choice
needs to be based not on the dentists' bias but on facts," said a
Pennsylvania dentist.

Mercury's unique properties can cause amalgam fillings to expand,
sometimes causing permanent tooth damage. "With time they
undoubtedly cause cracks in teeth," said a Tennessee dentist. "They
take more tooth structure away than necessary," agreed an Oklahoma
dental hygienist.

Lots of dentists no longer place amalgam. "I stopped doing them 24
years ago. I would not place something in a patients mouth that the
government does not allow in their sewer systems," said one
pediatric dentist.

To the average cosmetic dentist, it's simply a matter of
aesthetics. "[Amalgam fillings] are still the best, but ugly..."
sighed a Texas prosthodontist.

"Cosmetic dentistry favors more aesthetic composite fillings," said
Jim Du Molin, dental management consultant and founder of the dental
website The Wealthy Dentist. "However, it's clear that lots of
dentists still love amalgam. And though the mercury might be
dangerous, composites have not been proven to be perfectly safe
either. What's a consumer to do??"






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VETERANS NEWS



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Lou Gehrig's disease patient takes to D.C.

Veterans are twice as likely to get ALS; Ken Patterson wants
answers.

Kate Santich | Sentinel Staff Writer


April 19, 2008

While Ken Patterson still has a voice -- before he is completely
bedridden and fed through a tube -- he wants answers.

The former Army sergeant wants to know why those who've served in
the military are twice as likely to get Lou Gehrig's disease as
those who haven't served. And he wants to know what the politicians
controlling research funds are going to do about it.

"They worry more about giving little blue pills [Viagra] to old men
than the 30,000-plus people with this disease," said Patterson, 39,
of Titusville .

Today, Patterson begins a 940-mile journey from Orlando to
Washington in his battery-powered wheelchair. Traveling 50 miles and
10 hours a day -- with his wife, Glenda, trailing him in a van -- he
plans to collect letters from other patients and carry them to
Capitol Hill, raising awareness along the way.

"Somebody has to do it," he said. "Why not me?"

Patterson has amyotrophic lateral sclerosis, better known as ALS or
Lou Gehrig's disease -- a fatal neurological disorder that
progressively robs its victims of the ability to walk, speak, move
and, eventually, breathe. It leaves a perfectly alert mind in a
shell of a body.

Despite numerous studies showing that ALS is more common among
veterans and a 5-year-old ALS registry by the Department of Veterans
Affairs that now has 1,800 names, funding to unravel the mystery is
still meager. This year, the Department of Defense has requested $5
million to study possible treatments.

"We're happy to get it, but $5 million is nothing in the realm of
medical research," said Lucie Bruijn, national science director and
vice president of the ALS Association. "We can absolutely use more.
I think what he [Patterson] is doing is fantastic."


Not 'going to crawl in a hole'

Since his diagnosis with ALS in November 2006, Patterson has had
plenty of time to consider potential culprits.

Was it the jet fuel he was exposed to as a paratrooper? Did it have
anything to do with being a gunner on an anti-tank missile system?
Was it all the vaccines he was given -- as many as a dozen at a
time? Or perhaps the exposure came later, in his work as a safety
engineer for the Kennedy Space Center.

"You don't have enough space to write all the possibilities," he
said, his words already slurred from the disease.

A one-time firefighter and paramedic, Patterson first went to a
doctor in late 2005 for what he thought was a bad case of carpal
tunnel syndrome. His right hand hurt all the time, and his grip was
slipping. He couldn't turn his ignition key without using two hands.

It took three doctors, a gamut of tests and 11 months to get the
answer: He had a disease he didn't know anything about and a
prognosis of two to five years left to live.

"I got drunk," he said. "I couldn't have what they said. I
thought, 'I'm just getting to where I want to be in life. I'm still
a young man.' "

Divorced and the father of a son, he had been dating Glenda House
for nearly a year. He was about to begin work on his master's
degree. And at Kennedy Space Center , he was on track for a big
promotion.

In January 2007, Patterson quit work to spend what time he had left
with his family, and that spring he drove with Glenda to Washington
for an ALS candlelight vigil at the Capitol.

"I didn't see one news reporter, not one cameraman," he
said. "Nobody cared about ALS. Somebody had to do something. I
wasn't just going to crawl in a hole and die."

He began planning his mission. And in July, he and Glenda, 36,
married.


All services susceptible

On the way to Washington, the two plan to stop at Fort Stewart in
Georgia and Fort Jackson in South Carolina . They want to tell
soldiers there what scientists have learned: that it doesn't matter
whether you've been in the Army or Navy, Air Force or Marines. It
doesn't matter whether you've ever deployed overseas or fought in
combat. Patterson never made it out of Fort Benning , Ga.

Any time in the service raises the risk, though there might be no
sign of ALS for years or decades afterward. And for those who fought
in the Persian Gulf War of the early 1990s, the risk is higher
still. Again, the reason is unknown.

Since the disease was identified in 1869 -- decades before it struck
baseball great Lou Gehrig -- the prognosis of two to five years has
remained unchanged. And only one drug -- Rilutek -- has been
approved by the FDA for treatment. It is thought to extend life by
about eight to 12 weeks and costs about $1,000 a month.

"The disease is still a rare one," said Bruijn, a molecular
biologist. "It's not as if everyone in the military is suddenly
going to get ALS. But the fact that it is increased leads us to the
theory that there is some sort of environmental exposure involved,
and we need to identify what that might be."

Earlier this year, scientists isolated a gene that causes some forms
of ALS, indicating a genetic predisposition.

The most likely scenario, experts say, is that the disease comes
from that genetic vulnerability coupled with exposure to an
environmental toxin.

Realistically, Ken Patterson probably won't live long enough to find
out. But he likes to think otherwise.

"I'm going to stick around another 90 years just to piss the world
off," he said.




Thank you for supporting Hadcorp.

Hadcorp News: May 27, 2008





PLASTIC SURGERY NEWS




Woman gets killer plastic surgery

CJAD
Montreal,Quebec,Canada

Tue, 2008-05-27 05:36.

David Cohen

A young Montreal woman went in for a nose-job, she ended up dead.
25-year-old Valérie Castonguay died Thursday following complications
on the operating table at the René Crépeau plastic surgery clinic on
Seaforth, just off Côte-des-Neiges below Doctor Penfield.

The report says there were complications linked to the anesthesia.
She was taken by ambulance just up the road to the Montreal-General,
where she died.


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Delayed immune-mediated adverse effects of polyalkylimide dermal
fillers: clinical findings and long-term follow-up.

Arch Dermatol. 2008 May;144(5):637-42.


Alijotas-Reig J, Garcia-Gimenez V, Miró-Mur F, Vilardell-Tarrés M.
Josep M de Segarra, 2-F, 08190-Sant Cugat del Vallés, Barcelona,
Spain. 16297jar@...

OBJECTIVE: To evaluate the clinical complaints, laboratory data,
treatment, and follow-up of patients with delayed adverse effects
related to polyalkylimide implants (PAIs).

DESIGN: Prospective case series of patients injected with PAIs.

SETTING: A university tertiary teaching hospital.

PATIENTS: A prospectively acquired series of 25 patients with severe
and/or persistent delayed adverse effects after PAI injection. The
patients underwent clinical follow-up, a battery of blood tests, and
when possible, biopsy and chest radiography.

MAIN OUTCOME MEASURES: Clinical evaluation of granulomas, skin
manifestations, and other local and systemic immune-mediated
disorders possibly related to PAIs.

RESULTS: The average latency period for onset of symptoms was 13.4
months. Eight patients were previously injected with another
implant. Tender inflammatory nodules were seen in 24 patients.
Systemic or distant manifestations appeared in 6 cases. Laboratory
abnormalities were found in 20 cases. After an average of 21.3
months of follow-up, 11 patients appeared to be free of adverse
effects, and 10 still had recurrent bouts.

CONCLUSION: Although infrequent, delayed and recurrent chronic
inflammatory and granulomatous reactions may complicate PAI fillers.

PMID: 18490590 [PubMed - in process]


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My new boobs burst

May 14 2008 by Janet Tansley

Liverpool Echo
UK

Janet Tansley speaks to a woman who wishes she'd never had a boob
job – and wants to warn others of the potential health risks
SUSAN Craney was desperate to get her old figure back ...

Now she would just like her life back.

For the last few years Susan, 51, has endured a painful battle to
finally have breast implants removed after they burst.

While her road to recovery is still long and troubled, Susan is glad
they are gone but now prays for her health to return.

"I feel I went in for a boob job and came out with bad health," says
Susan.

"In the end I just wanted them taken out."

Throughout her ordeal, however, there has been one bright light in
the darkness – Susan's good friend, April Skinner.

"She phoned me every night, offered to come to all my hospital
appointments, and brought me flowers and chocs," smiles Susan.

"She put everything to one side to support me. She is one-in-a-
million."

Now she has won the chance to repay her after winning Look's
competition to win a pamper break at the luxury Carden Park Hotel
near Chester.

Says Susan: "We've always said how nice it would be to get away but
it was hard to find the time – and the money.

"April has been such a good friend."

Susan, from Knotty Ash, became depressed after childbirth and weight
loss left her unhappy with her body.

"I'm not a young girl with starry eyes," says Susan, a mother-of-
three.
"I didn't want to be Jordan, I just wanted to get my figure and
confidence back."

But it wasn't long after the operation five years ago that Susan
suspected something was wrong.

"Both breasts looked okay but I always had pain and discomfort with
the right one," she says.

"A year later I started to get lumps under my arms. Then a large one
appeared under my right arm."

During all this time Susan's health began to suffer: "I had constant
flu-like symptoms. I was achy and tired, and I even started to lose
my hair. I was menopausal but I felt it was more than that.

"I was certain that something was wrong, that the silicone implants
were leaking.

"I was always into the gym and keeping fit but eventually I had to
stop going because I didn't have the energy.

"I even had to go part-time in my job in a department store because
I just couldn't keep up with it full-time," she adds.

Susan repeatedly returned to the clinic where the operation had been
carried out to be told, she says, that she needn't worry.

But Susan didn't believe them.

Even visits to her GP proved fruitless. Susan underwent numerous
mammograms and ultrasound examinations, but none showed anything
abnormal.

It was only when she saw a new female doctor after she moved to
Knotty Ash, that the true horror was revealed.

"It was in November last year," says Susan. "She sent me for an
urgent MRI scan which revealed the implants had burst. I was
horrified."


When Susan went back once more to the clinic they agreed to remove
them – for a fee.

They told Susan – who is now taking legal action against the clinic –
  that she would be left disfigured and her chest would `virtually
cave in' unless she had them replaced with alternative implants.

But when, she says, they told her the cost would rise again, Susan
says she just wanted them out.

The implants were removed just over a month ago.

"I grabbed my notes, which said both implants had badly ripped, and
when I asked to see them, they were both split."

Susan's chest was flat – "it had just collapsed" – but after two
weeks she started to get some shape and reckons it's better than
before the implants.

But there are still health issues.

Susan's lymph glands still have silicone in, she says, from the
leaking implants. While attempts could be made to remove them, she
would be left with swelling and some loss of hand control.

She continues to have ill health which she believes are associated
with what's happened.


Now working as a make-up artist Susan is praying for the best
outcome.

"I am angry that no-one listened to me, because this could have all
be sorted a long time ago.


"Now I want to get well again and get my life back."

Susan thanks her children who helped her through and April who, she
adds, "was a tower of strength".


She adds: "Implants are great in the right context – for cancer
patients for example – and I know people who have had them for years
without any problems.

"But I would urge young girls who look through glossy magazines
picking what size chest they want to stop and think.

"I wish to God I had never done it."

The clinic which carried out Susan's breast augmentation declined to
comment.


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Push for stricter plastic surgery rules swells in wake of death of
Kanye West's mother

Lawmakers and physicians' groups want increased oversight of doctors
performing cosmetic procedures in outpatient facilities.

By Rong-Gong Lin II, Los Angeles Times Staff Writer

May 26, 2008

SACRAMENTO -- -- Six months after the mother of Kanye West died
following liposuction and breast implant surgery, the reverberations
of the tragedy continue to be felt. Now lawmakers and physicians are
urging greater protections for patients undergoing cosmetic surgery.

Across the country, such surgeries are increasingly done outside
hospital settings in outpatient clinics, where a doctor can avoid
the rigorous review that, say, a heart surgeon would face at a
traditional hospital.

Those lobbying for greater surveillance say attempts to regulate the
fast-growing industry have faltered.

"These [clinics] are not hospitals. You have to raise the
standards," said state Sen. Mark Ridley-Thomas (D-Los Angeles),
chairman of the senate Committee on Business, Professions and
Economic Development.

California is not alone in looking to tighten oversight of doctors
performing cosmetic surgery. Two years ago, Florida passed a law
designed to educate patients about their doctor's credentials.

And in the Canadian province of Ontario, officials are increasing
scrutiny after the death of a Toronto woman who received liposuction
from a general practitioner.

More than a decade ago, California pushed to regulate outpatient
surgical centers amid high-profile reports that patients were
critically injured or dying during procedures.

Legislators passed a law that said such centers must be accredited
by an agency recognized by the state, which requires a clinic to
have resuscitation equipment and procedures to transfer a patient to
a hospital.

But Ridley-Thomas says the law has not been effective; he has
proposed legislation requiring regular inspections.

In addition, across-the-board budget cuts forced the Medical Board
of California about five years ago to disband a five-person
investigative team designed to ferret out unlicensed doctors, said
board spokeswoman Candis Cohen.

The budget cuts came as cosmetic procedures overall were booming in
popularity. In 2007, there were 11.7 million cosmetic procedures
performed in the United States, a 59% increase over 2000.

In California, the death of Donda West, 58, in November prompted two
lawmakers to push for additional patient safety protections.

A bill, AB 2968, by Assemblywoman Wilmer Amina Carter (D-Rialto)
calls for a patient to receive a physical examination before
undergoing cosmetic surgery.

Yolanda Anderson, West's niece, said her aunt did not receive a
physical exam by her surgeon, Dr. Jan Adams, before undergoing
surgery.

A spokesman for Adams has previously said it was his understanding
that both Adams and the anesthesiologist thoroughly questioned West
before her surgery.

"It's not like she was 90 or terminally ill with cancer," Anderson
said. "It was something that did not have to happen."

Another doctor whom West had previously seen declined to operate on
her, saying that she was at risk of having a heart attack if she
were to undergo the cosmetic surgery.

A coroner's report cited West's heart disease and clogged coronary
arteries as a factor in her death. According to the coroner, there
was no evidence that her death was caused by a mistake in surgery.

West, who was 5 feet 2 and weighed 188 pounds, had part of her right
breast removed, both breasts enlarged and her abdominal muscles
tightened.

She had significant liposuction as well as a "belt lipectomy," which
excises fat around the abdominal area and tightens the surrounding
skin.

West was sent home after her 5 1/2 -hour surgery.

She was not hooked up to medical equipment to monitor her recovery,
something experts now say should have been required, given her
extensive surgery and her pre-existing heart disease.

Ridley-Thomas' legislation, known as SB 1454, would require that
outpatient facilities be inspected at least once every three years.

There now is no state requirement for how often the facilities must
be inspected.

New advertising requirements would go into effect, such as banning
statements or photos "likely to create false or unjustified
expectations."

But some doctors say that some of the additional regulations being
proposed won't fix what will affect the patients most.

"There's no way to control surgical judgment," said Dr. Michael F.
McGuire, vice president of the American Society of Plastic Surgeons
and an associate clinical professor at UCLA.

A solution, McGuire said, is for patients to know how qualified
their surgeons are.

McGuire said he wants all healthcare providers, including cosmetic
surgeons, to disclose their educational background and specialty
training before treating patients, an idea he has pressed with
lawmakers.

The idea would be a more robust version of a "Truth in Medical
Education" law passed in Florida in 2006.

In this scenario, a patient would receive a document detailing the
practitioner's license, identifying the provider's schooling,
residency training program, what boards had certified the physician -
- and what boards the doctor failed to complete, McGuire said.

State law permits medical doctors to practice whatever medicine they
want, which "goes back to the old general practitioner days where a
doctor delivered you, fixed your broken bones and took care of your
heart attack," McGuire said.

McGuire said he would favor laws allowing only doctors who are board
certified in plastic surgery to perform cosmetic procedures.

West's doctor, Adams, who has promoted himself as an expert on
cosmetic surgery in books and on TV shows, is not board certified in
plastic surgery or any other specialty overseen by the American
Board of Medical Specialties.

But McGuire said "any legislation that tries to limit in any way a
doctor's ability to practice" would face tremendous political
opposition from other doctors.

One province in Canada, however, does precisely that.

In British Columbia, doctors must be recognized as plastic surgeons
or otherwise certified by the Royal College of Physicians and
Surgeons of Canada to perform major cosmetic surgical procedures,
such as liposuction or anything involving a scalpel.

And in Ontario, officials are considering barring doctors from
calling themselves "surgeons" unless they are certified as such by
the Royal College.

In September, a 32-year-old real estate agent who lived in Toronto
died after receiving liposuction from a general practitioner.

The California Medical Assn. would oppose Canadian-style
restrictions, said its president, Dr. Richard Frankenstein.

Physicians must be vetted by an independent medical staff and
malpractice insurers before they can pick up a scalpel in
California, Frankenstein said in a prepared statement.

"The Canadian model wouldn't enhance these protections and would
risk depriving people who live in underserved areas of access to
physicians," he said.

Certification is not a guarantee of competence.

There have been cases where board-certified plastic surgeons are
involved in cases of gross negligence, said Janie Cordray, research
director for the Medical Board of California.

In Florida, the state increased oversight over non-hospital
surgeries after at least 12 people who underwent surgery in office-
based settings died in 1998, said Chris Nuland, general counsel to
the Florida Society of Plastic Surgeons.

The number of reported deaths has decreased, but a couple of
patients still die each year, Nuland said.

He said that a significant problem is doctors who inappropriately
clear patients who are too ill to have the surgery.

For example, he said, "a 55-year-old obese person with diabetes,
there is no reason that person should have been selected for an
office surgery," Nuland said.

"You can't legislate good medical judgment."



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Ottawa prepared to slap toxic label on widely used chemicals

Canada.com
Don Mills
Ontario,Canada
Sarah Schmidt , Canwest News Service

Published: Saturday, May 17

OTTAWA - The federal government announced Friday it intends to slap
a toxic label on a bunch of chemicals used in everyday products from
chewing gum to cosmetics as well as in controversial devices like
silicone breast implants because they are either harmful to human
health or the environment.

The 11 chemicals include Vinyl acetate, a carcinogen used as a base
in chewing gum, and Cyclohexasiloxane, used as building blocks of
silicone used in breast implants.

If industry fails to offer new information within 60 days to reverse
course, Ottawa will classify these chemicals as toxic and kick start
a process that could lead to a ban in certain products, as with
bisphenol A in baby bottles.

In the case of the synthetic chemicals belonging to the
Cyclohexasiloxane family - D4, D5 and D6 - the government is
proposing an additional step to ensure their virtual elimination
from the environment.

In addition to being found in silicone fluids, these synthetic
chemicals are found in cleaning compounds, cosmetics and personal
care products, including shampoos, creams, lotions, and
antiperspirants. D5, in particular, is a common ingredient to give
products a silky texture.

The government concludes these synthetic chemicals do not pose a
risk to human health, but rather should be declared toxic to the
environment.

"Canadians expect their government to protect the environment from
harmful chemicals, and that's why we are taking action," said
Environmental Minister John Baird.

Six of the 11 chemicals are flagged as toxic to human health; the
government said it will work with industry to reduce exposures to
two of these substances.

The health toxins are: Vinyl acetate, used in food additives,
paints, sealants and plastics; C.I. Pigment Yellow 34 and Red 103, a
colourant used in paints, dyes, inks, and plastics; Thiourea, used
in electronic products, insecticides and textiles; isoprene, used in
rubber and plastic manufacturing; and Oxirane, used in paints,
coatings and adhesives.

The announcement comes after a lengthy review of the chemicals under
the government's Chemicals Management Plan involving about 200
substances. It is the most comprehensive chemical review currently
being undertaken in the world.

Mike Patton, spokesman for the Canadian Cosmetics, Toiletries and
Fragrances Association, praised the process and welcomed the
conclusions.

``There's nothing in this batch that poses a health concern for us.
But our other interest is environmental impact, and we'll work with
the government to minimize or eliminate entirely any environmental
impact.''

Thiourea, a carcinogen, used to be a common ingredient in personal-
care products, but it hasn't been used by the industry for some
time, said Patton.

Women health advocates say they'll use this new information to push
for a review of the October, 2006, lifting the ban on silicone
breast implants.

The government's newly released risk assessment of D4, found in
silicone breast implants, states the synthetic chemical impairs
fertility. It also flags a finding of the Danish Environmental
Protection Agency, identifying the liver as a ``target organ for D4
exposures.''

But the government concludes the substance ``is not entering the
environment in a quantity or concentration or under conditions that
constitute or may constitute a danger in Canada to human life or
health.''

Madeline Bosco, a nurse who is executive director of Canadian
Women's Health Network and public appointee to the government's
advisory committee on breast implants, says research shows silicone
is not well-contained in the implants and diffuses throughout
women's bodies.

``This is extremely good news from my perspective. It helps move the
toxicology world, which has already been raising questions about
silicone, into the health products process.''

Epidemiologist Diane Zuckerman, president of the National Research
Center for Women & Families based in Washington, characterized
Health Canada's decision ``confusing and illogical. If D4 is
dangerous to the environment, on what basis is the government
concluding that it is not dangerous when implanted inside the human
body or repeatedly used on the human body?

``A more accurate assessment would have been to say that the health
hazards are unknown for individual use of products with D4, because
they have not been adequately studied. I would think that women of
childbearing age would be especially concerned about having breast
implants because of possible infertility problems that could result
from D4.''

Silicone implants were pulled from the market in Canada in 1992 amid
concerns they were unsafe for women. In October, 2006, Health Canada
changed course and made them freely available to women with the
caveat that ``no medical device is 100 per cent safe.''

Until then, only breast implants filled with saline were licensed
for sale in Canada.

The October, 2006 decision came just months after Health Canada's
scientific advisory committee said questions ``had not been
sufficiently addressed'' about potential health risks should the
gels bleed or leak into women's bodies and about whether the
implants increase the risk of auto-immune diseases in the long term.
The government is also proposing to list Acid Blue 80, a colourant
used in cosmetics and glass cleaner, as toxic to the environment.



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Botox Migration a Recipe for Disaster

Lawyers and Settlements
USA


Hollywood, CA: As new research continues to reveal that Botox, and
Botox Cosmetic may not necessarily be the risk-free, never-give-it-a-
second-thought cosmetic treatment that people eat up like candy,
there are those who look beyond the potential dangers and even
beyond the need.

It's called growing old gracefully.

Botox has been around far longer than most would suspect, as the use
of Botox for cosmetic purposes is a fairly recent indication.
Botulinum toxin has been used for years to treat muscle spasms,
which prove debilitating for some people and has been, according to
some, a godsend for helping to control limb spacticity in patients
suffering from cerebral palsy. Most, however, have received Botox
injections for eye and neck spasms.

The use of Botox for cosmetic purposes was actually pioneered by an
ophthalmologist in Vancouver, B.C. twenty years ago. Dr. Jean
Carruthers was using botulinum toxin to treat a client with an eye
condition, and noticed the positive effect the Botox had on her
patient's skin. "My poison will get rid of your patient's wrinkles,"
she is said to have told her dermatologist husband in comments
appearing in Maclean's magazine.

And Botox Cosmetic was born.

Popularly, we know it simply as Botox, and know it as the stuff that
removes wrinkles. Which is true. It's HOW the Botox removes wrinkles
that is the stuff of science. Botulinum Toxin Type A is a purified
form of the nasty stuff more commonly associated with botulism, the
horrible thing we can get from canned food that has gone bad.
Botulism can kill. However purified, the toxin has found a
legitimate use. It works by interrupting the communication between
nerve cells, temporarily paralyzing injected muscles.

Given the fact that wrinkles are caused by the contracting of facial
muscles, it has been found that relaxing, or temporarily paralyzing
those muscles, gets rid of the wrinkles. It's temporary—about three
months or so—but it's just a jab, vs. painful, invasive and
expensive surgery.

Little wonder Botox exploded in popularity. Last year Botox
represented over a billion dollars in worldwide sales for its
manufacturer, Allergen. In a few short years it has grown to become
the #1 cosmetic treatment in the world. Last year a drop-in
storefront Botox clinic opened on Manhattan's exclusive Upper East
Side. Dentists in British Columbia in Canada, and in the United
Kingdom have been given the nod to offer Botox injections in their
practices. Women find it's handy to hide the Botox injection bills
from their husbands, as it is classified as a dental service (albeit
elective).

And Botox has been pressed into service for temporary earlobe and
neck lifts, for mitigation of underarm sweating, and even the so-
called 'Botox boob job,' whereby botulinum toxin is injected into
the pectoral muscles, which somehow raises the breasts.

However, it should be noted that the US Food and Drug Administration
(FDA) only approved Botox Cosmetic for use in the horizontal lines
between the eyebrows. Two months ago, the US drug regulator put
Botox under a safety review after dozens of adverse reactions were
reported. As well, sixteen deaths have been linked to the use of
Botox, according the advocacy group Public Citizen.

Within the same time frame, new and disturbing findings have begun
to emerge which cast some doubt as to the ultimate safety of Botox.

The concern, which initially only circulated through medical
journals but has since been widely reported in mainstream media,
surrounds the potential migration of the neurotoxin from the initial
injection site. A study by the Italian National Research Council
discovered that Botox injected into the whisker muscles of rats, had
migrated in trace amounts to the brain stem in as little as three
days.

A Canadian study achieved similar results. Last month the Journal of
Biomechanics published the findings of Walter Herzog, a noted
kinesiologist from the University of Calgary. While researching
osteoarthritis and joint degeneration, he found that botulinum toxin
injected into the supporting muscles of cats not only paralyzed the
muscles into which the toxin was injected, but had spread into, and
weakened all muscles in the area.

Supporters of Botox and botulinum toxin, as does Alleregen, argue
that Botox has proven safe and effective. However these latest
findings are injecting a newfound caution into the mix. Dr. Peter
Misra, from the National Hospital for Neurology and Microsurgery in
the UK, writes in the British Medical Journal, "In this atmosphere
of 'Botox parties' - where champagne-sipping socialites are injected
with botulinum toxin - it is easy to forget that it is a potent
neurotoxin and that its very long-term effects are still unknown.

"Robust evidence for the action of botulinum toxin (Botox) on
sensory neurons is lacking."

While there has been only one death potentially linked to the
cosmetic use of Botox, this newfound concern regarding the ability
for the toxin to migrate has some people worried. For example, were
Botox injected into the face for cosmetic purposes, or into the eye,
or neck muscles for therapeutic purposes, effectively migrate down
to the esophagus, there could be dire consequences.

If you have been injured, or negatively impacted from a Botox
injection in any way, have a Botox lawyer inject some legal muscle
into your case.


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MORE PLASTIC SURGERY NEWS


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RealSelf and Lifestyle Lift reach settlement


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GULF WAR SYNDROME


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Dedman College honors Robert Haley as Distinguished Graduate

North Texas e-News

TX,USA

By Levente Smith, SMU

May 20, 2008


Robert Ware Haley, whose research has helped improve hospital care
and define the symptoms of Gulf War Syndrome, was honored recently
as the SMU Dedman College 2008 Distinguished Graduate.

Haley is director and founder of the Division of Epidemiology in UT-
Southwestern Medical Center's Department of Internal Medicine, as
well as its U.S. Armed Forces Veterans Distinguished Chair for
Medical Research Honoring America's Gulf War Veterans. He graduated
from SMU in 1967 with degrees in philosophy and social sciences.



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AGENT ORANGE


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Veterans returning from overseas for Vietnam apology

TV3 News
Auckland, New Zealand
Tue, 27 May 2008 05:42a.m.


Vietnam veterans, due to receive an apology from the Crown tomorrow,
have been waiting more than 30 years.

The apology, to be made by Prime Minister Helen Clark in Parliament,
will acknowledge veterans were not treated fairly when they returned
to New Zealand from the war.

Veterans have for years fought for recognition of the suffering
experienced by soldiers exposed to toxic chemicals used during the
war, such as Agent Orange.

Many veterans found the people of New Zealand had little time for
them after they returned from serving in the largely unpopular and
controversial war.

Tomorrow's apology will precede three days of commemorations for the
Vietnam veterans, beginning with a civic welcome in Wellington's
Civic Square at 4pm on Friday.

Long in the planning, the commemorative weekend "Tribute08" is the
public face of a memorandum of understanding signed in December 2006
by the Government, the Ex-Vietnam Services Association and the Royal
New Zealand Returned and Services Association.

In the memorandum, the Government acknowledged Vietnam veterans and
their families had legitimate concerns about their treatment over
the past 30 years.

A $30 million package aimed at compensating veterans and their
families affected by chemical warfare used during the Vietnam War,
including the use of Agent Orange, was announced last year.

Official events over Queen's Birthday weekend include an honour
march to Parliament on Saturday morning; a whakanoa, or tapu-
lifting, ceremony to acknowledge the 37 New Zealanders who died in
Vietnam; a memorial service at the National War Memorial on Sunday
and a commemoration event at the Basin Reserve.

A concert will be held on Saturday night, and public exhibitions and
displays will be held at various venues throughout Wellington.

Hundreds of veterans are already registered, and thousands of
supporters are also expected to take part over the weekend.

One veteran will be in attendance with 12 family members, arriving
from as far away as Sweden.

Pete Ramsay was with Victor 4 Company in Vietnam. Six of the
company's men were killed in action and 14 were wounded.

Mr Ramsay is now based in Western Australia, but is the New Zealand
Ex-Vietnam Services Association representative for the Australian
state.

He said it was "critical" veterans attended the commemorations, and
bring their families along.

"I know it can be a job to organise it but it's well worth it.
Families talk to other families, wives talk to wives. If doing that
helps one family out in some way, to understand Dad, then that's
great."

Mr Ramsay said he was looking forward to catching up with old
friends at designated sub-unit watering holes around Wellington.

He said the discussions were unlikely to be about what happened in
Vietnam.

"We all know what we went through over there, and we don't need to
talk about it to each other. We're over that. We talk about the
silly and humorous things that happened, and there were plenty of
those."

Mr Ramsay said the memorandum would have a lasting impact on
veterans, and not just those from Vietnam.

"...it's also for other veterans, especially the younger ones so
they've got some sort of support mechanism to fall back on if they
need it.
"We don't want younger veterans to be treated the way we were
treated by veterans of previous wars, or forgotten like the Korean
veterans."


Ex-Vietnam Services Association spokesman Chris Mullane said
veterans and their supporters needed to attend Tribute08 to ensure
their concerns continued to be addressed.

"The Government and the public of New Zealand need to see our
participation as a tangible demonstration of the determination and
credibility of the Vietnam veteran community," he said.

A total of 3890 New Zealand soldiers served in South Vietnam. Thirty-
seven were killed in action and 187 were wounded.

New Zealand's longest-serving combat unit in the war was 161
Battery, Royal NZ Artillery, which served from June 1965 to May
1971.
From 1961 to 1971, US and South Vietnamese armies sprayed millions
of litres of toxic herbicides to destroy forest cover and food for
communist forces.

Herbicides used in the Operation Ranch Hand defoliation were
identified by coloured stripes on containers: Agent Orange was the
most widely used.

Veterans overseas have since blamed the spray for health problems
such as diabetes and prostate cancer in former soldiers, and birth
defects in their children.

After years of successive governments denying New Zealand soldiers
were affected by Agent Orange, a parliamentary health select
committee inquiry concluded in October 2004 that it was "beyond
doubt" that New Zealand defence personnel were exposed to Agent
Orange and other herbicides.

The inquiry followed the publication of the John Masters map which
revealed heavy American spraying of Agent Orange and other
defoliants in Phuoc Tuy province, where most New Zealand soldiers
spent much of their time in Vietnam.



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Australia cancer deaths linked to Agent Orange

• Town's rate 10 times state average, says researcher
• Call for inquiry into claims of secret testing in 1960s

Barbara McMahon in Sydney

The Guardian

UK

Monday May 19 2008

Claims by a leading researcher that cancer deaths in a small town in
Queensland, Australia, are 10 times higher than the state average
owing to the secret testing of Agent Orange there more than 40 years
ago are to be investigated by the authorities.

Australian military scientists sprayed the toxic herbicide on
rainforest near Innisfail during defoliant testing in the early
years of the Vietnam war, it is alleged. The jungle began dying and
has never recovered, according to local people.

The site is near a river which supplies water for the town in the
far north of the country and researchers believe the spraying may be
responsible for cancer rates in the area being 10 times the state
average and four times the national average.

The Innisfail claims were made by the researcher Jean Williams, who
has been awarded the Order of Australia medal for her work on the
effects of chemicals on Vietnam war veterans. She said she found
reports of the secret tests in Australian War Memorial museum
archives.

"These tests carried out between 1964 and 1966 were the first tests
of Agent Orange," she told Fairfax Media.

Williams said one of the files on the testing was marked "considered
sensitive" and showed that the chemicals 2,4-D, Diquat, Tordon and
dimethylsulphoxide had been sprayed on the rainforest.

"It was considered sensitive because they were mixing together all
the bad chemicals, which just made them worse," she said. "Those
chemicals stay in the soil for years and every time there is a storm
they are stirred up and go into the water supply."

Williams also claimed that a file which could prove that wider
testing took place had gone missing from the archives.

A former soldier, Ted Bosworth, has backed up the claims, saying two
scientists he drove to the site in the 1960s were interested in the
effect the chemical cocktail had on rubber vine, which is also found
in Vietnam.

"They sprayed the trees by hand and then in the next couple of weeks
I took them back up and they put ladders up against the trees and
took photos of them as the foliage was dying," he said. "They called
it some other funny name - I hadn't heard of Agent Orange then."

Agent Orange was sprayed by the Australian and the US military
during the Vietnam war to defoliate jungle where North Vietnamese
troops were positioned. The cocktail of toxic chemicals in Agent
Orange has been linked to cancer, birth defects and other health
problems.

Yesterday the local mayor, Bill Shannon, called on the Australian
Defence Force to investigate Williams's claims. He said the half-
acre site remains deforested, and though the town's water supply
showed no evidence of the chemicals, local people had long been
concerned about cancer rates in the area. "I'd like to know exactly
what did happen and the extent of it. We don't want a cover-up," he
said.

Queensland's premier, Anna Bligh, said she was disturbed by the
claims. "Any concerns these residents have can and will be
investigated thoroughly," she said in Brisbane yesterday.

However, the Queensland health department said that the incidence of
cancer in Innisfail is no higher than in other parts of the state.

• This article was amended on Tuesday May 20 2008. Queensland's
premier is Anna Bligh, not Blyth. This has been corrected.


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DENTAL AMALGAM


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Inside Today's Bulletin

Philly First In The Nation To Require Mercury Disclosures

By: JENNY DeHUFF

Evening Bulletin

Philadelphia,PA,USA

05/14/2008

Philadelphia - Freya Koss said she developed multiple sclerosis,
lupus and other health problems from a silver dental filling
containing mercury. She and several other consumer advocates and
health professionals were at City Hall yesterday to tell their
stories of cavity fillings gone wrong.

The Pennsylvania Coalition for Mercury-Free Dentistry and Consumers
for Dental Choice (CDC) stood in front of large signs warning of the
dangers of silver amalgam fillings - most notable for their high
levels of the neurotoxin mercury.

In December, Philadelphia City Council unanimously passed
legislation backed by Councilwoman Blondell Reynolds Brown that
requires dentists to distribute patient brochures disclosing the
dangers of silver amalgam fillings.

"The textbooks don't tell us this," said Charlie Brown, spokesman
for the CDC. "It is absurd to think nothing is damaged when a
neurotoxin is placed an inch from someone's brain."

"I quickly learned of the harrowing effects of mercury when an old
filling was removed and a silver filling replaced it," said Ms.
Koss, director of the Pennsylvania Coalition for Mercury-Free
Dentistry. "Seven days later, I got sick."

Don Robbins operates a mercury-free dentist practice out of Exton.
He called himself one of the few dentists committed to informing
patients of the risk of silver amalgam fillings. Holding a jar of
dental mercury filling, Mr. Robbins pointed out the skull and
crossbones icon on the label, warning that the substance is
hazardous to children and to handle the container with gloves and
protective gear.

"It's deeply disturbing what's going on in our profession," Mr.
Robbins said. "Less than 60 percent of dentists in the U.S. belong
to the American Dental Association (ADA). Silver fillings are 50
percent mercury. If you have two, three or more silver fillings, you
are above the Environmental Protection Agency's (EPA) limit for
mercury intake."

Earlier in the day, consumers protested statements made by the
president of the Pennsylvania Dental Association. "No dentist places
mercury in a patient's mouth," he was reported to have said.

The alternatives to these types of fillings are typically white
composite resin fillings, which are more commonly used today but
don't last as long as silver fillings.

Jenny DeHuff can be reached at jdehuff@....


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MORE DENTAL AMALGAM NEWS


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FDA Opens Public Comment for Safety of Mercury in Dentistry (Action
Alert)



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GM FOODS


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Bad seed

Meg Hewings

New doc exposes disturbing facts about Monsanto's impact on the
world's fragile food supply

To big multinationals like Monsanto, we humans are mere guinea pigs.
Don't believe me? Go see The World According to Monsanto. When the
doc, by renowned investigative journalist Marie-Monique Robin,
streamed on the ARTE.tv website in France, the traffic and
conversation it generated busted their server. That's because the
film, like the book version (which sold over 40,000 copies to date
in France), finally presents a cogent and horrifying enough picture
of the world's leading seed manufacturer to warrant concern and fury
(and I'll go out on a limb here and predict this film won't just
enrage the protest-happy French).

The book, like the film of the same title, provides unpublished
documents and first-hand accounts by victims, scientists and
politicians, and clearly lays out how the industrial giant has lied,
colluded with the American government and used extreme pressure
tactics on scientists in order to gain market supremacy. (Today, the
US company's genetically modified organisms (GMOs) represent 90 per
cent world GMO crops, have been planted in over 46 countries and
threaten to destroy the agricultural biodiversity that has served
mankind for thousands of years.)

It's not that worrying trends like global climate change and the
current global food crisis can be blamed entirely on Monsanto. It's
just that anyone still naive enough to think that multinationals
have our back, or care one fig about the environment, has his head
in the sand.

Monsanto has long argued that biotechnology is the solution to
hunger and environmental contamination, and for many in the
scientific community and in politics during Bush senior's tenure,
that may have been the hope. Yet the Monsanto company profile has
never been trustworthy. They've manufactured some of the most toxic
products ever marketed, including PCB and Agent Orange. They've also
managed to bury all the evidence that proves the toxicity of their
products, some of which are unauthorized in Canada and Europe. To
make matters worse, the company has become the leading manufacturer
of GMO seeds and aims to take possession of (and patent!) the
world's crop seeds (yes, all those fundamental to the world's food
supply). They've also managed to bypass (or buy out) all their
friends in government (or hire them!) as well as at the FDA (Food
and Drug Administration in the U.S.), who've yet to subject these
supposed miracle crops to rigorous independent testing or
safeguards.
Surely, this doesn't bode well for us, or our planet, when a
company's greatest crimes can somehow turn into their best-kept
secrets for pulling off world domination (a.k.a. market supremacy).
Be damned the notions of food safety and the ecological balance of
our planet!

The film's simple investigative style and its rich array of expert
talking heads lend it, and its findings, gravitas. The film is far
from fancy, but the basic question is simple: Can we really afford
to trust a company like Monsanto to safeguard our world food supply?
There can be few surprises left in the answer.

If you're feeling the weight of the world on your shoulders and want
to do something about it, make sure to check out Green Screens, a
weeklong environmental event organized by the NFB featuring
screenings, discussions and workshops. From May 26 to 31. For more
information and to screen other NFB films about the environment
online, go to www.nfb.ca/footprints.




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Montoliu: Exploring the complex GMO issue

Lake County News

Lakeport,CA,USA


Written by Raphael Montoliu

Friday, 23 May 2008

"I have not yet seen anyone glow green from eating GM tomatoes from
the local supermarket," Supervisor Rob Brown said, responding to a
caller on the GMO issue while being interviewed on KPFZ's Future
Knowledge Tuesday evening.

This offhand response toward the end of the interview seems an
appropriate representation of the extent of research some
politicians, local or otherwise, undertake to make important, public
policy decisions ... in the context of a strong antagonism towards
anything that does not seem to fit their narrow ideology or
interests rather than through actual analysis.

Since we now know that objectivity regarding this topic is lost in
at least one corner of the Board of Supervisors chamber, let's
restore it here and look at the biotech industry objectively,
particularly at some very critical, crucial, undisputable facts.

Simply put, the Food and Drug Administration (FDA) wasn't allowed to
do its job. Documents made public from a lawsuit (has anyone noticed
how the public has to sue the government to get any answers to any
relevant questions?) show that the overwhelming majority of FDA
scientists felt that biotech foods were inherently dangerous and
could create poisons or allergens, new diseases, or nutritional
problems, particularly in infants and children.

These FDA scientists urged their superiors to require a long-term
study. However, the FDA was under orders from the White House to
promote the biotechnology industry. They consequently created a new
position to bypass the science and the regular FDA channels of
research and approval, called the "Deputy Commissioner of Policy,"
and hired Monsanto's former attorney to this position, Michael
Taylor. Yes, you read correctly, an industry insider lawyer made,
alone, a "scientific" decision that will affect the American
population for the coming centuries.

So Taylor became the lone "decider" at the FDA, under Bush and in
the interests of the biotech industry. I wish I was making this up,
but it is a sad reality of today's government, that has totally
escaped public control and escaped its own morality, if it even had
any.

Taylor was in charge of policy when the GMO policy was created. That
policy stated that the agency was not aware of any information
showing that the foods created from these new experimental methods
differed in any meaningful or uniform way from any other. On the
basis of that one sentence, the FDA declared, "We require no safety
studies whatsoever" ... this regarding a technology that is one of
the biggest scientific breakthrough in decades, and radically alters
the DNA of our food.

Consequently when Monsanto and others claimed that their foods were
safe, the FDA had no further questions, having being reduced to
nothing more than an impotent rubber stamp bureaucracy at the
service of dominant corporate interests by the Bush administration.

Of course the FDA decision was an outright lie from the top. Not
only was the agency aware of the important differences of GM foods,
but the overwhelming consensus among its scientists-whose objections
were suppressed-was that further studies were necessary before
releasing these products to farmers and consumers.

The consistent denials and coverups about the health risks of GM
foods are very similar to what went on with the tobacco and
particularly the cigarette industry, as researches by the industry
are rigged to guarantee conclusions of safety, the GM industry
meticulously designing their so called studies to avoid finding
problems.

The biotech industry has a genetically engineered counterpart to
virtually every fruit, vegetable, grain and bean that is being sold
in the United States. More than 172 different species have been
field-trialed, with more than 50 000 field trials in the US alone.

Soy, corn, cottonseeds, canola, potatoes, cocoa, Hawaiian papaya,
zucchini and yellow squash are currently the major GMO crops. There
are many dairy products made from cows injected with rBGH (synthetic
growth hormone), and there are genetically modified enzymes and food
additives that are usually not listed on the label of processed
foods. Many supplements are created from genetically engineered
bacteria or microorganisms. The wine industry is looking at GMO
grapes.

As GM crops are predictably and unavoidably beginning to contaminate
all other forms of agriculture, European standards for organically
grown food are being lowered to include trace amounts of GMOs, these
amounts expected to rise significantly in the coming years, which is
why a biotech industry representative stated cynically that "the cat
is already out of the bag," meaning that they had already altered
the global food supply and that resistance was futile precisely
because of contamination, while stating at the same time that
contamination would not be a problem, yet suing farmers whose fields
are contaminated ...

The transfer of genes is a very serious issue, ignored by the FDA
and the industry. The only human feeding study ever conducted on GM
foods demonstrated that the genes inserted into soybeans transfer
into human intestinal bacteria DNA and remain there, integrated on a
stable basis, never eliminated. The implications regarding the genes
that produce GM pesticides, that could remain in the intestinal
flora, or transfer into our own cellular DNA, causing it to produce
foreign proteins, could be devastating.

Back in the 1980s, 100 people died and anywhere between 5,000 to
10,000 fell sick or were permanently disabled after ingesting a
brand of L-tryptophan supplement that was manufactured through a
genetically modified bacteria. The FDA however, after pulling all
such supplements off the market, withheld information from the
public and from Congress about the genetic engineering aspect of the
problem.

In Europe, a GM food researcher named Arpad Pusztai discovered that
supposedly harmless GM potatoes caused massive damages to rats. He
was fired from his job after 35 years and silenced with threats of a
lawsuit. In Russia, a leading researcher in the Russian Academy of
Sciences discovered that female rats that were fed GM soy had an
infant mortality rate that was over 50 percent within the first
three weeks, compared to only 10 percent of the offspring with
mothers who were fed non-GM soy. This scientist has since been told
she could not do any more GM food research.

Most people do not realize that there have not been extensive and
independent tests on GM foods. Most people do not even know what GMO
means, yet they ingest an unproven, experimental, highly
controversial, untested, revolutionary "Frankenstein" food that
could have devastating consequences for their health and
particularly that of their children ...

The points made by Rob Brown on the GMO issue during his interview
are all invalid.

It is easy to demonstrate that those who have an "agenda" are not
the people who seek to get a moratorium on all GMOs until further
studies are completed by independent scientists, a process which any
reasonable person would demand and support, the heavy-handed agenda
comes from those who have stealthily forced this technology on the
American consumer without such proper and prudent studies, without
the labeling of GM products as is required in Europe, and with the
help of a corrupted bureaucracy; the only existing agenda here comes
from the industry itself and those who support it and its distortion
and strangulation of science in the name of immediate profits.

Objective scientific research is not an agenda, it is not
political ... to ask that FDA scientists be allowed to do their jobs
is not an agenda ... to request that a new product be held until
considered safe by the FDA after such required studies is not an
agenda.

And no, the power to decide whether to have GMOs in Lake County
cannot be given exclusively to farmers or the farm bureau, who are
not scientists and have no appropriate science upon which to base
their decisions, it must be given to the greater public through he
restoration of an honest and independent FDA process of scientific
research and approval or rejection of GM products. Short of this and
under current corrupt conditions, the American public must educate
itself and demand to be heard, and to be respected. Alfalfa is not
the only issue in Lake County, other GM crops will eventually be
available to replace traditional crops, as in the case of
winegrapes, and GE pears will certainly be available at some point.

According to the Chicago Tribune, the Bush administration is
attempting to force famine stricken third world countries, mostly in
sub-Saharan Africa, to plant genetically engineered crops, as part
of a $770 million aid package, just as it has bullied Iraq to also
plant GE crops.

These untested and mostly unregulated GE crops are considered
controversial all over the world; at least 40 nations have
restricted GE farming and GE ingredients in foods by requiring,
because of public demand, mandatory labeling. (A majority of the
American public has also demanded labeling of GMO products, but in
America, giant corporations have more rights and apparently more
powerful votes than ordinary citizens, particularly under Republican
regime). A number of nations and regions have banned GMOs in
agriculture altogether, until further research proves it is safe.

Beyond health and environmental concerns, and contrary to industry
propaganda, GE crops do not significantly increase yields, but
rather force farmers to stop saving their seeds and instead buy
toxic chemicals and highly priced patented seeds from biotech
companies such as Monsanto, Syngenta, Bayer, Dupont, Dow's and BASF.
Once they do, they no longer have a choice, as their fields are
contaminated at the DNA level and will remain so forever.

Is forever a good choice concerning an untested and potentially
dangerous technology that could affect our own human DNA in
unpredictable ways?

Sources of information:

Books: "Seeds of Deception" and "Genetic Roulette," both by Jeffrey
Smith; "Genetically Engineered Foods," by Martin Teitel and
Kimberley A. Wilson; "Codex Alimentarius: Global Food Imperialism,"
by Scott Tips.

The Non-GMO Project, a nonprofit organization created by leaders
representing all sectors of the organic and natural products
industry in the US and Canada.



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Few checks to prevent entry of GM food

Hindu
Chennai,India
Sarah Hiddleston



CHENNAI: Ports in India face an enormous burden in scientifically
analysing products from countries growing genetically modified
crops.
No GM organisms can be imported unless sanctioned by the Genetic
Engineering Approval Committee, the nodal agency that functions
under the Ministry of Environments and Forests.

Only two food imports have been approved, according to an MoEF
response to an RTI submission: refined vegetable soybean oil and
crude degummed soybean oil by Catholic Relief Services and Care
India as food aid in 2002. But a couple of weeks ago, packets of
Doritos potato chips available in select supermarkets, including in
Chennai, were revealed to contain two strains of GM corn.

An independent German laboratory found Mon 863 (for pest tolerance)
and NK603 (for herbicide tolerance) in a sample picked up by
Greenpeace from Delhi. The U.S.-based manufacturer Pepsico says that
it does not market the product in India and has not exported it
directly.

The supermarket is believed to have acquired it through an
independent importer via Mumbai.

Mandatory certificates attesting the GM status of imports checked at
customs and the judgment of Port Health Officers at the 16 points of
entry into India are the only checks in the system to prevent raw or
processed food items that have unlawful GM strains from turning up
in products in the market.


Sources in the Health Ministry said that samples of all food imports
are tested for safety.

But tests for GM strains are not performed on a regular basis. Not
all ports have facilities to detect genetic engineering, and though
samples of consignments can be sent for testing elsewhere, these
laboratories are overburdened, senior officials from customs and the
Port Trust point out.

The scale of the task involved in checking suspicious consignments
is large; food items from countries that grow certain GM crops,
including Argentina, Brazil and the U.S., might not be GM-free
because those governments do not require crop segregation or food
labelling, Dr. Ajay Parida, MS Swaminathan Research Foundation, told
The Hindu.
Manufacturers in these countries, he said, do not test for GM
strains because they say it would increase the price of the food
items and pass the burden to the consumer.

The Food Safety and Standards Act, 2006, entrusted a regulatory body
under the Ministry of Health and Family Welfare with the
responsibility for GM foods.

The body, known as the Food Safety Standard Authority, together with
the scientific panel for genetically modified organisms the Act
recommended, has not yet become functional.

Prevention of Food Adulteration Rules 2006 places the responsibility
for authorising GM foods back with the GEAC. In August last year,
the GEAC exempted GM processed food where the end product was not
living, such as oils from GM seeds, from the 1989 rules for
import/manufacture of GM organisms.

However, the exemption was on February 25, 2008 held in abeyance
until September 30, 2008 or until further notification by the
Ministry of Health and Family Welfare regarding regulation of GM
processed foods.
The Food Safety Standards Authority, headed by Mr G. Balachandran,
is expected to begin working next month.













Thank you for supporting Hadcorp.

http://www.freewebs.com/implants/

Command Trust Network

May 20, 2008



Dear Sandra,


I'm so pleased to tell you that we have a great champion in United
States Senator Barbara Boxer of California, who late last week
introduced a bill (S.3020) to bring greater accountability and
transparency to the FDA's regulation of silicone breast implants and
all medical devices.

When the FDA approved the use of silicone implants in 2006, it
failed to live up to its mandate of ensuring that the product was
safe before allowing it to go on the market. Instead, the FDA
decided to allow manufactures to conduct post-approval studies to
demonstrate the safety of the implants once they were implanted.
However, in a matter of a few months, the manufacturers convinced
FDA to change the requirements of the studies, without any public
input. And we learned that the FDA was essentially a "toothless
tiger" when it came to going after medical device manufacturers who
drag their feet or fail to submit data from their studies. Mary and
I set out to correct these injustices by approaching Congress with
our findings and Senator Boxer responded.

S.3020 prevents FDA from unilaterally and secretly waiving or
altering a post-approval agreement with a manufacturer, without
letting the public know. The bill also gives FDA greater authority
to force manufacturers to comply with their post-marketing
agreements, by increasing fines and requiring public notification
that could lead to the removal of the product from the market.

Please send Senator Boxer a note of thanks for introducing this
vital and necessary legislation. The medical device manufacturers
are a $75 billion industry with a lot of influence in Washington,
D.C., so it's very important that Senator Boxer know we support her.

The easiest and most effective way is to visit her website and
simply fill in the email form. Under the heading of "message topic"
choose "Women's issues," and under the heading of "Message Subject,"
type in "S.3020 FDA Accountability and Transparency Act."

In the message box, please thank the Senator for introducing the
bill. Her bill is vital to making sure FDA and the public receive
all information necessary to make an informed decision about whether
or not medical devices are safe. And let her know that FDA needs
more enforcement authority to punish device makers who delay or fail
to disclose information.

Please alert your networks, family and friends. Encourage them to
express their support for the bill and to thank Senator Boxer.

Mary and I will be in Washington, D.C. next month and we'd love to
hear the Senator tell us about all the emails she received from in
support of the bill!

Sincerely,

Sybil Goldrich
Command Trust Network

Hadcorp News: May 7, 2008





PLASTIC SURGERY NEWS




Breast Augmentation with Stem Cells Available in Europe

Pamela Jones
May 5, 2008

Dr. Heinrich in Vienna, Austria is the first doctor in Europe to
offer breast augmentation using stem cell concentrated own-fat.
First, the body fat is extracted by microcanulas. After
concentrating the fat with stem cells from the patient, the fat is
injected into the breasts. The injection site heals without
scarring. None of Dr. Heinrich's patients have experienced any
adverse events following this procedure.

Q & A WITH DR. HEINRICH


What is the difference between stem cell-concentration and stem cell-
enrichment?

The first is done only with centrifugation and just concentrates
stem cells in fat. The second is done in a complex
encymatical/centrifugal procedure that enables the harvesting of
stem cells from one portion of fat and adding them to another
portion of the fat.


How much breast volume can a patient gain realistically?

The average increase is one to two cup sizes. The implanted volume
is almost completely retained. The maximum is 300cc on each side for
1 procedure; the average is 150cc.


What is the cost of the treatment?

This depends on the procedure (stem cell-concentration or stem cell-
enrichment) and ranges from 7000 - 15000e.


How do the cells know when to stop growing in the breast?

Every stem cell ripens into just one fat cell or tissue cell.



How long does the procedure take?

4 – 6 hours.


What type of anesthetic is utilized for the procedure?

Local or sedoanalgesic.



What is the recovery time and are there any special instructions
given after the procedure?

One to 2 days. Patients are advised to be very careful with their
breasts for a few days.


Is the effect of the treatment permanent or are touch-ups necessary?

The effect is permanent. Touch- ups can add more volume if
requested.


What are other uses for stem cell concentrated fat?

Body contouring and skin rejuvenation.


Copyright 2008, Pamela Jones and Hadcorp. All rights reserved.



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Judge Throws Wrinkle Into Plastic Surgery Trademark Claim

Wired News
USA
By David Kravets

May 05, 2008 | 3:49:54

A Michigan judge is dismissing a lawsuit brought by a plastic
surgery firm against a web site that posted its readers' critical
reviews of the firm's cosmetic services.

The suit by Lifestyle Lift Holding Inc. claimed infomercialscams.com
of violating its trademarks because Lifestyle's trademarked name
appeared on the URLs of infomercialscams.com.

Ruling from the bench, Judge Arthur Tarnow on Friday agreed with the
defendant that infomercialscams.com was exercising free speech.

Tarnow said the URLs did not confuse web users to mistakenly believe
that the infomercialscams.com site was related to Lifestyle Lift
Holding.

Many of the online complaints were from women who said they had a
face-lift after seeing Lifestyle's infomercials. One woman claimed
she lost hearing in one ear. Another said "every week my face
proceeds to return to the way it was before the lift." Another
said, "I feel ripped off."

The lawsuit was a bid to stifle free speech, according to Public
Citizen, which defended the case.

"Their theory was that somebody might run on to this review site on
Google, and that was confusion," said Paul Levy, a Public Citizen
attorney. "That's why we have the First Amendment here."

Had the court ruled otherwise, Levy said, the decision would have
given a green light to unhappy companies to invoke federal trademark
law to limit speech it did not approve of.

Lifestyle, based in Michigan, licenses its name to cosmetic facial
surgeons, who promote the trademarked name "lifestyle lift" for
cosmetic surgery procedures performed in dozens of offices
nationwide.

The company sued Justin Leonard, an Arizona man who runs the
infomercialscams.com site. Lifestyle claimed Leonard's use of
Lifestyles URLs violated its trademarks. The complaint, filed in the
Eastern District of Michigan, said its surgeons have
received "positive television coverage" on ABC, CBS, NBC, Fox, UPN
and WGN.


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MEDICAL DEVICE NEWS


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Treatment of recurrent ventriculoperitoneal shunt failure associated
with persistent cerebrospinal fluid eosinophilia and latex allergy
by use of an "extracted" shunt

J Neurosurg Pediatrics 1: 237-239, 2008

Case report

Michael J. Ellis, M.D.1, Colin J. Kazina, B.Sc., M.D.1, Marc R. Del
Bigio, M.D., Ph.D., F.R.C.P.C.2, and Patrick J. McDonald, M.D.,
M.H.Sc., F.R.C.S.C.1

1 Section of Neurosurgery, Department of Surgery; and 2 Department
of Pathology, Faculty of Medicine, University of Manitoba, Winnipeg,
Manitoba, Canada

Abbreviations used in this paper: CSF = cerebrospinal fluid; VP =
ventriculoperitoneal.

Address correspondence to: Patrick J. McDonald, M.D., M.H.Sc.,
F.R.C.S.C., Section of Neurosurgery, Department of Surgery,
University of Manitoba, Winnipeg Children's Hospital, GB126–820
Sherbrook Street, Winnipeg, Manitoba, Canada R3A 1R9. email:
pmcdonald@....

DOI: 10.3171/PED/2008/1/3/237

Shunt failure is commonly associated with infection or mechanical
obstruction of the shunt system. The presence of eosinophilia in the
cerebrospinal fluid (CSF) has been associated with CSF shunt failure
and may be related to both latex and shunt allergies. The authors
describe the case of a child with a latex allergy who presented with
10 episodes of shunt failure over a period of 93 months.
Cerebrospinal fluid sampling demonstrated persistent eosinophilia (3–
36%) and negative cultures. Pathological examination of the
ventricular catheter on 3 occasions demonstrated mechanical
obstruction by inflammatory debris consisting largely of eosinophils
and multinucleated giant cells. On the suspicion that the child
might have some uncharacterized allergy to the shunt hardware, shunt
replacement was performed using an "extracted" shunt system. The
child has remained free of shunt malfunction for > 2 years since the
last surgery. Immune responses to unpolymerized silicone are
discussed.



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Virginia Judge Rules Medical Device Pioneer Committed Malpractice

By Patrick Malone & Associates, P.C.

The principal U.S. investigator for the Maverick(TM) artificial disc
device has been found liable for malpractice in his use of the
device by a state court judge in Richmond, Va. Garver v. Mathews, CL
No. 07-206, Circuit Court, City of Richmond, Va.

Judge T.J. Markow awarded damages of $650,000 against Hallett H.
Mathews, M.D., and Midatlantic Spine Specialists, P.C. Dr. Mathews
is a prominent spine surgeon who now works as a vice president for
Medtronic, the manufacturer of the Maverick(TM) Artificial Disc.

The damages were awarded to Eric M. Garver, M.D., who is himself a
spine surgeon in Bridgeport, Connecticut. Dr. Garver traveled to
Richmond in April 2005 to undergo surgery by Dr. Mathews, who
installed a Maverick at the L5-S1 level of Dr. Garver's spine.

The device consists of two metal plates that fit into the patient's
disc space with a ball and socket between them, which is intended to
maintain the natural mobility of the disc as an alternative to
traditional spinal fusion. See the manufacturer's web site for more
details:

http://www.maverickdisc.com/about-maverick-disc.html.

Judge Markow, who heard three days of evidence in a lawsuit brought
by Dr. Garver, issued a written decision in which he found that Dr.
Mathews had violated "the standard of care in preparing the disc
space for insertion of the Maverick artificial disc." The standard
for the surgery, written by the defendant himself and other spine
surgeons, required that the disc space be "meticulously cleared of
materials that might be driven into nerves behind the disc space by
insertion of the artificial disc," the judge wrote. In the Garver
surgery, Dr. Mathews, while inserting the artificial disc, drove
material from the disc space into the patient's S-1 nerve root on
his right side. This caused permanent injury to the nerve with pain
and difficulty using the right leg.

A fragment of bone and disc the size of an olive was retrieved from
Dr. Garver's spine two weeks after the Mathews surgery by a
neurosurgeon in Bridgeport, Conn. That surgeon, Dr. Patrick
Mastroianni, testified at the trial that he found the fragment
pressing against the nerve root. Removal caused some relief of Dr.
Garver's symptoms, but he ended up with a chronic pain syndrome that
is poorly controlled even taking multiple drugs every day. His
previous condition, with back pain and pain going into his left leg,
was cured by the Mathews surgery.

At the time of the surgery, Dr. Mathews was a surgeon in private
practice who ran one of 32 sites in the United States at which the
Maverick device was inserted into selected patients, and who also
was the principal U.S. investigator for the manufacturer's
application to the Food and Drug Administration. The device is still
considered experimental while the Medtronic application to the FDA
is pending.

According to testimony at trial, Dr. Mathews received consulting
fees from Medtronic of around $700,000 in 2004 and 2005, although he
was not paid anything for the clinical trial itself. Dr. Mathews
testified that he gave up his surgical practice at the end of 2006
to work full-time for Medtronic. His current position is Vice
President Medical Affairs for Medtronic Spine and Biologics'
division in Memphis, TN. Mathews is a former member of the board of
directors of the North American Spine Society, a group of surgeons
who specialize in spine surgery.

Dr. Garver was represented at trial by Patrick Malone of Patrick
Malone & Associates, P.C., of Washington, D.C.,
http://www.patrickmalonelaw.com and Thomas Albro and Lee Livingston
of Tremblay and Smith, L.L.P., of Charlottesville, Va.



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BIG PHARMA


---------------------------------------------------------------------
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Former Shill for Big Pharma Tells the Truth About Drug Testing

Natural News.com

Phoenix, AZ, USA

Tuesday, April 29, 2008 by: Heidi Stevenson


NaturalNews) Erick Turner, a psychiatry professor at the Oregon
State Health and Sciences University, woke up one day and realized
that he was acting as a shill for pharmaceutical corporations.
Worse, he was promoting drugs that not only provide very little
benefit, but also do great harm. In spite of the benefits paid to
him, including accommodations and thousands of dollars, and the ego
satisfaction of being recognized as a "Very Important Person" by his
fellow physicians, his conscience wouldn't let him continue.

So, Dr. Turner turned on his pharmaceutical masters. He spoke out
against the products he'd been promoting. In the January 2008 issue
of the New England Journal of Medicine, he published an article
telling the truth about one class of drugs, SSRI antidepressants,
such as Prozac and Paxil. In interviews, he has spoken even more
broadly, stating that the lack of efficacy of SSRIs is the "dirty
little secret" of the psychiatric world.

Dr. Turner's odyssey began in 2004, when he started selling his
reputation by giving "doctor talks", as they're called in the
industry.

These lunches or dinners are lavish affairs, provided by
pharmaceutical corporations. A doctor who is appealing, for either
his or her background or appearance and style -- preferably both --
speaks about the wonders of a particular drug. Erick Turner's
particular appeal was having been a researcher at the National
Institute of Mental Health for seven years, and then a clinical
trials reviewer at the FDA.

He was trained by Eli Lilly to give talks, which required that he
use only the visuals provided by the pharmaceutical firm and stay
with their talking points. Then, Turner was sent to do doctor talks.
The money he made wasn't significant to him, $500-750 per talk, a
small amount in terms of his total income. However, as he put
it, "In the beginning, I think I got narcissistic gratification.
They fly you somewhere else in the country and pick you up in a
limo, and you stay in a nice hotel you could never afford
otherwise."

Within 18 months, though, Turner began to feel pangs of conscience.
As he put it, "I guess you could say I bit the hand that fed." He
published a paper in PloS Medicine that argued for online
publication of all clinical trials produced for the FDA. Although he
went from drug company advocate to critic overnight with his
argument against pharmaceutical hiding of data, the article was...
well, it was ignored.

His article was met with a big yawn in the medical world.

Turner quit giving the doctor talks and started to search for hidden
drug trial data. At first, he found some in hidden-away parts of the
FDA's website. He then looked to researchers for data, and got it
from a Seattle researcher and one at the University of Nevada at Las
Vegas. "I literally went down to a Kinko's," Turner stated, "and
photocopied them."

The studies he'd found consisted of 74 clinical trials, with 51%
showing results that were better than placebo and 49% with negative
or mixed results. In other words, about half the trials, though
they'd been produced for drug corporations and most likely were
attempting to produce the desired results of showing benefits, did
nothing of the sort.

Armed with the smoking gun proof of negative trials being hidden,
Turner produced a paper, "Selective Publication of Antidepressant
Trials and Its Influence on Apparent Efficacy" for the New England
Journal of Medicine. This time, he wasn't ignored.

Daniel Carlat, assistant professor of psychiatry at Tufts University
School of Medicine, himself once on the dole with Wyeth
Pharmaceuticals, argues, "The fact that the negative trials can just
be hidden away means that practicing doctors can get a very false
notion of efficacy data for a drug. That's the real crisis here."

The question that must be answered is how pervasive the
pharmaceutical firms' hiding of negative studies is. It's obvious
from Erick Turner's exposé that SSRIs are generally useless. What
about other drugs? History shows us that the same must be true.

Take, for example, Vioxx, an NSAID used for arthritis and other
chronic pain. It causes heart attacks and has killed over 60,000
people in seven years. Could its manufacturer, Merck, have withheld
information from doctors and the public?

Did Wyeth withhold information about Fenphen, two drugs combined to
act as a single weight loss drug? It killed people by causing
pulmonary hypertension.

What information was withheld by Hoechst Marion Roussel on Seldane?
It was a wildly popular prescription antihistamine, which was
withdrawn because it caused heart arrhythmia.

The number of drugs withdrawn because of their risks, which were
likely known by the manufacturers, is stunning.

The cat is now out of the bag regarding SSRIs. If they work, it's
only rarely. The known risks are extensive and appalling. Most, if
not all, school shootings involved the use of SSRIs, or their next-
generation offshoot, SNRIs. Suicide rates increase after starting
them. Weight gain is often a problem, indicating a potential link to
diabetes. Sleep disturbances and sexual dysfunction are fairly
common. Many people have a great deal of difficulty withdrawing from
these drugs. None of these problems were revealed during pre-
approval clinical tests, but the fact that they're common begs the
question. How many trials showing these dangers were suppressed?

Ultimately, the real question is how many people have died or
suffered irreversible harm from ingesting the products of drug
manufacturers?

How much information is being hidden by the pharmaceutical
manufacturers, all in the interest of obscenely high profits?

How innocent are doctors in all this? It's quite clear that they
have been deeply involved in the cover-up. Whether they benefit from
gifts or boosts to their egos from doing bogus doctor talks, or
simply fall for the cute sales reps -- recruited primarily from the
ranks of cheerleaders -- so that they close their eyes to
pathetically weak statistics, how believable is it that they don't
know? When thousands of people outside the medical profession can
find out the truth about pharmaceutical poisons, why do the doctors
seem to be largely unaware?

You might think that Dr. Erick Turner, the man who exposed the
withholding of negative information by drug manufacturers, would
have stopped prescribing the SSRI drugs that he focused on. But
that's not the case. Although he says that he doesn't give patients
false hope about their efficacy, he still prescribes them.

It's no wonder that doctors are so disconnected from reality. From
the time they're in medical school, they're bombarded with pseudo-
information from pharmaceutical manufacturers. They receive gifts to
such a degree that a Lancet study found "approximately 50% of the
items that residents carry have pharmaceutical company origins".

When doctors enter private practice, it's hardly surprising that
they often become billboards and prescription machines for
pharmaceuticals. As Dr. Jay S. Cohen wrote, "No wonder patients
complain that many doctors look like walking advertisements for the
drug industry."

Pharmaceutical corporations are so pervasive that, as described by
the Washington Post in 2002, "In the days leading up to the American
Psychiatric Association's meeting in Philadelphia [2002],
pharmaceutical companies mailed attendees hundreds of free phone
cards, as well as invitations to museums, jazz concerts and fancy
dinners... And in several dozen symposiums during the week long
meeting, companies paid the APA about $50,000 per session to control
which scientists and papers were presented and to help shape the
presentations."

Is it any wonder that doctors have become so utterly disconnected
from their responsibility to protect their patients from harmful
drugs?

It's no wonder that they seem to be so unable and unwilling to look
at drug company reports critically. It's no wonder that they have
become little more than drug pushers, forever pressing the latest
pills on their patients, without considering the risks and the
obvious suppression of information about the products they
prescribe. It's no wonder that when, finally, after a few years of
prescribing a particular poison, they're informed that it's been
recalled, they immediately jump on the bandwagon of yet another
highly-promoted, research-suppressed so-called "wonder" drug. And
then, they repeat the pattern yet
again.

The pharmaceutical industry has so controlled the medical industry --
  and with the doctors' full cooperation -- that even the doctor who
blew the whistle seems to have no idea how to proceed without
prescribing the very medications that he knows are ineffective in
most cases.


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Canada's C-51 Law To Outlaw 60% of Natural Health Products

Don't Let Big Pharma Do This To Canada

Center for Research on Globalization

Montreal, Quebec, Canada

Global Research

April 30, 2008

canadafreepress.com

A new law being pushed in Canada by Big Pharma seeks to outlaw up to
60 percent of natural health products currently sold in Canada, even
while criminalizing parents who give herbs or supplements to their
children. The law, known as C-51, was introduced by the Canadian
Minister of Health on April 8th, 2008, and it proposes sweeping
changes to Canada's Food and Drugs Act that could have devastating
consequences on the health products industry.

Among the changes proposed by the bill are radical alterations to
key terminology, including replacing the word "drug"
with "therapeutic product" throughout the Act, thereby giving the
Canadian government broad-reaching powers to regulate the sale of
all herbs, vitamins, supplements and other items. With this single
language change, anything that is "therapeutic" automatically falls
under the Food and Drug Act. This would include bottled water,
blueberries, dandelion greens and essentially all plant-derived
substances.

The Act also changes the definition of the word "sell" to include
anyone who gives such therapeutic products to someone else. So a
mother giving an herb to her child, under the proposed new language,
could be arrested for engaging in the sale of unregulated,
unapproved "therapeutic substances." Learn about more of these
freedom-squashing changes to the law at the Stop51.com website:

http://www.stopc51.com

New enforcement powers allow Canadian government to seize your home
or business

At the same time that C-51 is outlawing herbs, supplements and
vitamins, it would grant alarming new "enforcement" powers to the
thugs enforcement agents who claim to be "protecting" the public
from dangerous unapproved "therapeutic agents" like, say, dandelion
greens. As explained on the http://www.Educate-Yourself.orgwebsite
((http://educate-yourself.org/cn/canadian...), the C-51 law would
allow the Canadian government's thugsenforcement agents to:

• Raid your home or business without a warrant
• Seize your bank accounts
• Levy fines up to $5 million and a jail terms up to 2 years for
merely selling an herb
• Confiscate your property, then charge you storage fees for the
expense involved in storing all the products they stole from you
C-51 would even criminalize the simple drying of herbs in your
kitchen to be used in an herbal product, by the way. That would now
be categorized as a "controlled activity," and anyone caught
engaging in such "controlled activities" would be arrested, fined
and potentially jailed. Other "controlled activities" include
labeling bottles, harvesting plants on a farm, collecting herbs from
your back yard, or even testing herbal products on yourself! (Yes,
virtually every activity involving herbs or supplements would be
criminalized...)

There's more, too. C-51 is the Canadian government's "final
solution" for the health products industry. It's a desperate effort
to destroy this industry that's threatening the profits and
viability of conventional medicine.

Natural medicine works so well—and is becoming so widely used—that
both the Canadian and American governments have decided to "nuke"
the industries by passing new laws that effectively criminalize
anyone selling such products. They simply cannot tolerate allowing
consumers to have continued access to natural products. To do so
will ultimately spell the destruction of Big Pharma and the
outdated, corrupt and criminally-operated pharmaceutical industry
that these criminally-operated governments are trying to protect.

Join the rally to protest C-51

On May 9th, 2008, Canadian citizens will be gathering at the Calgary
Federal Court to protest C-51 and help protect their access to
natural health products. Call 1-888-878-3467 to learn more, or visit
the action page of Health Canada Exposed at: www.stopc51.com


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Patent Law Battle a Boon to Lobbyists

By ROBERT PEAR
Published: April 30, 2008

WASHINGTON — A fight has erupted in Congress over the question of
whether drug makers and other companies should be allowed to keep
patents they obtained by misrepresentation or cheating.

Jon W. Dudas of the Commerce Department said patent applications
were inadequate.


The issue has emerged as a contentious point in legislation to
overhaul patent laws. In several cases, the courts have voided
patents after finding that companies intentionally misled the Patent
and Trademark Office.

The legislation, affecting a wide swath of the American economy, has
been a boon to lobbyists. In 15 months, two dueling business
coalitions have spent $4.3 million lobbying on the legislation,
which calls for the biggest changes in United States patent law in
more than 50 years. Companies from almost every major industry have
joined the battle.

Patents can protect an invention for up to 20 years. But federal
judges can void patents after finding that companies engaged
in "inequitable conduct," meaning that they misrepresented or
concealed information with an intent to deceive the patent office.
In such cases, judges can declare the patents unenforceable.

Robert A. Armitage, a senior vice president and general counsel of
Eli Lilly & Company, said, "This is like imposing the death penalty
for relatively minor acts of misconduct."

Brand-name drug companies are urging Congress to eliminate the
penalty — or to curtail it as proposed under a bill passed by the
House.
Debra S. Barrett, a vice president of the American unit of Teva
Pharmaceutical Industries, the world's largest maker of generic
drugs, said the changes sought by brand-name drug companies "would
make it easier for them to cheat and get away with it, easier for
them to defend their patents and more difficult for us to get
generic products onto the market in a timely way."

Consumer groups like AARP share that concern. They want to speed
access to generic medicines, which can cost 30 percent to 80 percent
less than the equivalent brand-name drugs.

The House has approved a comprehensive patent bill that would make
it harder to prove inequitable conduct. Senators are haggling over a
companion bill, approved by the Senate Judiciary Committee, and hope
to take it to the floor this summer.

In the last 15 years, the United States Court of Appeals for the
Federal Circuit, which handles patent cases, has affirmed findings
of inequitable conduct in at least 40 cases, including 14 that
involved pharmaceutical or health care products. Similar findings
have been issued by federal district judges in an unknown number of
cases that were not appealed.

Courts have found that drug makers knowingly submitted false
statements to the patent office, inaccurately described experiments
and concealed information that contradicted their claims.

In one case, the appeals court said that Novo Nordisk
Pharmaceuticals improperly failed to disclose that it had not
performed an experiment described in its application for a patent
related to synthetic human growth hormone. In another case, the
court said Pharmacia had used an "inaccurate and misleading"
affidavit in obtaining a patent for a glaucoma medication.

Brand-name drug companies say that generic drug makers routinely
attack their patents by accusing them of inequitable conduct when
they are blameless or guilty of no more than honest mistakes.

The aggressive use of such accusations has become "a plague on the
patent system," the Biotechnology Industry Organization, a trade
group, told Congress.

Harry F. Manbeck Jr., who was commissioner of patents and trademarks
under the first President Bush, said the existing penalty was a
powerful deterrent to misconduct.

"Patents can be very valuable," Mr. Manbeck said. "There are strong
incentives to want to get them. Cheating occurs from time to time.
The inequitable conduct doctrine says that if you cheated to get a
patent, you should not be able to enforce it."

Under federal regulations, people applying for a patent have a duty
to deal with the patent office in "candor, good faith and honesty."
They are supposed to disclose if their invention was previously
known or used by others, offered for sale or described in a
publication. In that case, it may not be innovative enough to
warrant a patent.

In reviewing an application, patent examiners can search the
relevant literature, but may not find all the pertinent information,
so they depend on applicants to be forthright.

"If Congress eliminated or reduced the penalty for inequitable
conduct, applicants would no longer have a reason to disclose all
the information they are aware of," said Robert D. Budens, president
of the Patent Office Professional Association, which represents
5,500 examiners.

Mr. Armitage, the Lilly executive, said: "The doctrine of
inequitable conduct is used so aggressively in litigation that it
has unintended consequences. Applicants give the Patent and
Trademark Office too much information, to avoid allegations that
they concealed anything, and they refuse to explain the information,
to avoid later allegations that they engaged in some form of
misrepresentation."

James C. Greenwood, president of the Biotechnology Industry
Organization, said, "The poor patent examiner gets a dump truck full
of information that he has to pore over without any assistance from
the applicant."

The number of patent applications — 467,243 in 2007 — has nearly
doubled in the last 10 years and has more than tripled since 1987.
Jon W. Dudas, the under secretary of commerce for intellectual
property, said: "We are getting more and more unpatentable ideas,
worse and worse quality applications. Historically, in the last 40
years, the allowance rate — the percentage of applications
ultimately approved — hovered around 62 percent to 72 percent. It
went up to 72 percent in 2000, but dropped to 43 percent in the
first quarter of this year."

A major impetus for the patent legislation is the desire of
technology companies to limit the damage awards and legal costs they
sometimes face when they are accused of infringing patents.
Companies like Cisco and Palm say the disputes drain resources that
could be better spent on research and innovation.

Many of these companies have banded together in the Coalition for
Patent Fairness, which in the last 15 months has spent $2.5 million
for a small army of lobbyists including Mark W. Isakowitz, a
Republican, and Steven A. Elmendorf, a longtime Democratic
strategist.

A rival group, the Coalition for 21st Century Patent Reform,
consists of about 50 companies that zealously guard their
intellectual property and are more likely to file suit to protect
their patents. It includes pharmaceutical and biotech companies like
Genzyme, Lilly, Merck and Pfizer. This coalition has paid $1.8
million to lobbyists, much of it to the law firm of Akin Gump.


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GENETICALLY MODIFIED FOOD


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The global food system feeds gluttonous corporations first

Philadelphia Inquirer

Philadelphia, PA, USA

Posted on Sun, Apr. 27, 2008

John Nichols is Washington correspondent for The Nation magazine

The only surprising thing about the global food crisis to Jim
Goodman is the notion that anyone finds it surprising.

"So," says the Wisconsin dairy farmer, "they finally figured out,
after all these years of pushing globalization and genetically
modified seeds, that instead of feeding the world we've created a
food system that leaves more people hungry. If they'd listened to
farmers instead of corporations, they would've known this was going
to happen."

The food shortages, suddenly front-page news, are not new. Hundreds
of millions were starving and malnourished last year; the only
change is that as the crisis has grown, it has become more difficult
to "manage" the hunger that a failed food system accepts rather than
feeds.

The current global food system, designed by U.S.-based agribusiness
conglomerates like Cargill, Monsanto and ADM and forced into place
by the U.S. government and its allies at the World Bank, the
International Monetary Fund, and the World Trade Organization, has
planted the seeds of disaster by pressuring farmers here and abroad
to produce cash crops for export and alternative fuels rather than
grow healthy food for local consumption and regional stability.

The only smart short-term response is to throw money at the problem.
George W. Bush's release of $200 million in emergency aid to the
United Nation's World Food Program last week was appropriate, but
Washington must do more. Rising food prices may not be causing riots
in the United States, but food banks here are struggling to meet
demand as joblessness grows. Congress should answer the call of Sen.
Sherrod Brown (D., Ohio) to allocate $100 million more to domestic
food programs and make sure, as Rep. Jim McGovern (D.Mass.) urges,
that an overdue farm bill expands programs for getting fresh food
from local farms to local consumers.

Beyond humanitarian responses, the cure for the global food system -
and an unsteady U.S. farm economy - is not more of the same
globalization and genetic gimmickry. That way has left 37 nations
with food crises while global grain giant Cargill harvests an 86
percent rise in profits and Monsanto reaps record sales from its
herbicides and seeds. For years, corporations have promised that
problems would be solved by trade deals and technology - especially
genetically modified seeds, which University of Kansas research
suggests reduce food production and the International Assessment of
Agricultural Science and Technology for Development says won't end
global hunger. The "market," at least as defined by agribusiness,
isn't working.

We "have a herd of market traders, speculators and financial bandits
who have turned wild and constructed a world of inequality and
horror," says Jean Ziegler, the U.N. right-to-food advocate. But try
telling that to the Bush Administration or to World Bank president
(and former White House trade rep) Robert Zoellick, who's busy
exploiting tragedy to promote trade liberalization.


"If ever there is a time to cut distorting agricultural subsidies
and open markets for food imports, it must be now," says Zoellick.

"Wait a second," replies Dani Rodrik, a Harvard political economist
who tracks trade policy. "Wouldn't the removal of these distorting
policies raise world prices in agriculture even further?" Yes. World
Bank studies confirm that wheat and rice prices will rise if
Zoellick gets his way.
Instead of listening to the White House or the World Bank, Congress
should recognize - as a handful of visionary members like Rep. Marcy
Kaptur (D., Ohio) have - that current trends confirm the wisdom of
the Institute for Agriculture and Trade Policy's call for "an urgent
rethink of the respective roles of markets and governments." That's
far more useful than blaming Midwestern farmers for embracing
inflated promises about the potential of ethanol.

We should, however, re-examine whether aggressive U.S. support for
biofuels is not only distorting corn prices but also harming
livestock and dairy producers who can barely afford feed and
fertilizer. Instead of telling farmers they're wrong to seek the
best prices for their crops, Congress should make sure farmers can
count on good prices for growing the food Americans need. It can do
this by providing a strong safety net to survive weather and market
disasters and a strategic grain reserve similar to the strategic
petroleum reserve to guard against food-price inflation.

Congress should also embrace trade and development policies that
help developing countries regulate markets with an eye to feeding
the hungry rather than feeding corporate profits. This principle,
known as "food sovereignty," sees struggling farmers and hungry
people and says, as the Oakland Institute's Anuradha Mittal
observes, that it is time to "stop worshiping the golden calf of the
so-called free market and embrace, instead, the principle [that]
every country and every people have a right to food that is
affordable." As Mittal says, "When the market deprives them of this,
it is the market that has to give."


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AGENT ORANGE



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Seeking justice for veterans, By TOM LAVENTURE, Staff Writer

International Falls Daily Journal

International Falls, MN, USA

April 25, 2008 - 11:11am

Veterans fight to have Parkinson's declared service connected to
Agent Orange

U.S. Military Veterans With Parkinson's Disease, an organization of
about 150 members, is saying the Department of Veterans Affairs
should recognize that exposure to Agent Orange and other pesticides
during their service has a plausible connection.

They want Parkinson's added to the VA's "presumptive list" of Agent
Orange connected illnesses.

Jim Graham, 59, a former logger from Littlefork, and one-time Big
Falls mayor, was diagnosed with Parkinson's in 2000. His spouse,
Terri, said that around 1999, Jim began to experience tremors and
stiffness.

These days he can no longer talk on the phone because of the tremors
and a developed throat condition called Barrett's esophagus. Friends
are shocked to see the once physically fit logger having difficulty
eating and going through normal daily rituals. He continues his
walks despite the increasing difficulty with balance and movement.

"We have been through so much in the past year with the changes in
Jim and how it has progressed," said Terri Graham.

Approximately 1.5 million Americans suffer from Parkinson's disease,
a presently incurable neurological disorder that researchers believe
is caused by the progressive loss of dopamine producing cells,
possibly from a combination of genetic and environmental factors.

Jim Graham served in Vietnam as a U.S. Navy jet mechanic from 1968
to 1972. Until a few years ago, the only problems that he related to
his service was the occasional jungle rot and the VA gave him a 10-
percent service connected disability for tendonitis.

He divided his carrier duty with work at a Danang air base, an area
that was heavily sprayed with Agent Orange, a highly toxic,
undiluted Dioxin chemical that was produced as a byproduct in the
manufacturing of herbicides. The most toxic of the 75 Dioxins,
2,3,7,8 – TCDD, was used to destroy crops and to clear foliage
around base perimeters during the Vietnam War.

These chemicals were transported via air and sea in metal barrels
and without knowledge of their toxicity, USMVP members said the
containers were cut apart and reused in fortifications, for storage,
to make grills, latrines and shower bins.

The Grahams believe that Jim's illness is service related. They also
believe their two grown children and a daughter from Jim's previous
marriage all have inherited health problems related to his exposure.

"People should know what these vets are going through," she added.

Terri quit working to be a full-time caregiver for Jim. With their
mortgage paid off on their southeast Minnesota home in Dakota, she
helps him through the day and they enjoy their grandchildren
together.

Without much income, they keep the heat at 60 degrees and Terri
qualifies for MinnesotaCare. The VA considers Jim totally disabled
and eligible for care at the VA clinic in Tomah, Wis. His symptoms
can be treated at various stages through physical therapy,
medication and surgery.

The Graham's application for service connection for Parkinson's was
denied, as was his appeal. A third application will be reviewed in
May. They will submit 1,500 pages of research.

"I believe that we will win with the wealth of information," Terri
said. "It is amazing how far we have come in a year."

Jerry Andre, Koochiching County Veterans Service officer, said that
veterans with Parkinson's do come to him and he encourages them to
file service related claims while they wait for legislation to put
Parkinson's on the presumptive diseases list. He said it is also
worth checking to see if it was triggered by something else that is
service related.

"If medical evidence is supportive of the fact that Parkinson's was
incurred or aggravated during active duty then it will be treated as
any other service connected disability," Andre said.

The VA created an Agent Orange Registry for veterans possibly
exposed to dioxin or other toxic substances in herbicides. These
veterans include those who served in the Republic of Vietnam between
1962 and 1975; Korea in 1968 and 1969, or anyone exposed during
testing, transporting, or spraying herbicides for military purposes.

Several states have introduced bills calling on Congress to add
Parkinson's to the presumptive list. Minnesota Sens. Linda Higgins,
Steve Murphy, Don Betzold, Steve Dille and David Tomassoni
coauthored a bill in March that is currently in committee. A House
companion bill was introduced by Reps. Mary Ellen Otremba and Al
Juhnke.

Last year, the Grahams met with Steve Fiscas, a Minneapolis veteran
with Parkinson's who started the USMVP. The group met with House
Committee on Veterans Affairs Chairman Bob Filner, D-Calif., at a
community meeting sponsored by U.S. Rep. Tim Walz.

Both Walz and the Grahams expressed concern with the issue, but
according to Walz' office, before legislation can be introduced,
they need to work within the current budget rules and with input
from constituents and national veterans organizations. At that
point, they said that a bill would need to navigate the committee
process and receive expert testimony before it could get a vote.

The more expedient process is through the bi-annual Institute of
Medicine of the National Academy of Sciences report to the VA,
required by Congress as part of the Agent Orange Act of 1991. The VA
is directed to regard the findings among other evidence in using a
five-tier structure to consider additions to the presumptive
connections list. They range from definite link, to possible,
inconclusive, improbable, and no link at all.


The most recent 2006 Institute of Medicine report considered current
evidence "inadequate or insufficient" to determine an association
with Parkinson's and herbicide exposure.

The IOM committee called for specific research on disease
progression and suggested epidemiologic studies using VA data on
unusual health outcomes and for potential metabolic syndrome –
multiple health issues – among exposed veterans. It requested
investigations into exposure related birth defects and developmental
cognitive disease in offspring and grandchildren.

The report also recommended collaborative studies on the Vietnamese
people, which continue to exhibit long-term health consequences of
exposure to the same chemicals.

Given the response to past reports and studies, USMVP members are
doubtful the IOM study will impact change as legislation would. The
1990 Admiral Zumwalt Jr. report to the VA noted ample evidence to
link illnesses to exposure, and accused a VA special committee with
failing to act impartially toward the evidence. Parkinson's is not
mentioned in the report, as it had not yet appeared in veterans in
the 1980s.

"We believe it is a matter of time," said Alan Oates, another USMVP
member who served a full military career and retired to run a
business in Edinburg, Virginia. He began a petition to get the VA to
add Parkinson's to the presumptive list.

Oates is concerned that along with the IOM reports, the VA needs to
consider the evidence presented from at least three other credible
sources on agricultural pesticide exposure and comparison studies.
He feels Parkinson's would easily fall within the presumptive
spectrum if they did. Even if it were a close call, he said the VA
is charged to side with the veteran in such cases.

The VA has opened six Parkinson's Centers around the country since
2001. These research, education and clinical institutes also serve
to train VA providers nationwide who in turn treat approximately
40,000 veterans with Parkinson's. Current VA studies on Parkinson's
include deep brain stimulation and adult stem cell research in
addition to determining whether exposure to neurotoxins is a
trigger.

Oates feels that the Parkinson's centers are evidence to show the VA
expects to see larger numbers of Vietnam veterans with Parkinson's.
He has had little luck getting access to VA data.

USMVP is conducting a member survey to find out dates of service in
Vietnam, along with their Parkinson's diagnosis dates and other
service and health information. Oates hopes that the results will
reveal early onset Parkinson's, with a consistent diagnosis date of
around 32 years after service in Vietnam. Veterans can request a
survey via their website at www.usmvp.org.

"We also have a high rate of risk for other diseases already
presumed associated with Agent Orange," he added.

Christopher Reid, a physician and scientist in Neurobiology at
Charles University in Los Angeles, said despite the lack of data
available to public health specialists to investigate a possible
link, that there is a growing consensus that environmental exposures
are important to the development of the disease in some of patients.

He noted a 2006 Mayo study and a 2007 National Institute of
Environmental Health Sciences report, which indicated that certain
pesticides may increase the risk of developing Parkinson's more than
others.

Reid said the difficulty with discerning cause-and-effect
relationships with diseases is that it can take years or even
decades to appear after exposure to a toxin. He said this should
encourage health scientists to think creatively about how they
collect and analyze data.

As a West Point graduate from a military family, Reid said that if
science has been slow to investigate and remediate the full impact
of Agent Orange on veterans and those abroad, then this society is
responsible now, "to do something significant in the lives of those
affected."

"The scientific process is often instrumental and indispensable in
seeking and doing justice," said Reid. "A great example is DNA
testing in criminal cases. I think it is often the failure to fully
engage in the scientific process that produces injustice."

Agent Orange exposure

Diseases being studied as triggered from exposure to Agent Orange
and other herbicides: Parkinson's, tonsil and breast cancers,
melanoma, amyotrophic lateral sclerosis, lupus, ischemic heart
disease and stroke.

Service connected diseases

The current VA presumptive list of service connected diseases from
exposure to Agent Orange includes: chloracne or other acneform
disease similar to chloracne; porphyria cutanea tarda; soft-tissue
sarcoma, other than osteosarcoma, chondrosarcoma, Kaposi's sarcoma
or mesothe-lioma; Hodgkin's disease; multiple myeloma; respiratory
cancers such as lung, bronchus, larynx, trachea; non-Hodgkin's
lymphoma; prostate cancer; acute and subacute peripheral neuropathy;
Type 2 diabetes; mellitus; and chronic lymphocytic leukemia.


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AEROTOXIC SYNDROME


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There's something in the air


Last Updated : Friday 25 Apr, 2008

7DAYS

Dubai, United Arab Emirates

Catching the flu on an airplane could be the least of your worries
if an investigation by the BBC's Panorama programme holds any
weight. From pilots almost passing out at the controls to passengers
who claim that they have been made ill by toxic fumes, polluted air
on board planes is fast becoming a health topic of much concern.


The Panorama investigation, which aired on television recently,
revealed how air passengers could be exposed to toxic fumes in the
cabin while flying, as the air inhaled on airliners is drawn in past
the engines and can become polluted by any leaks of engine oil.
Panorama investigators took swabs and air samples during two UK
flights and toxicologist Professor Christiaan Van Netten, working
alongside the BBC, found traces of a neurotoxin - tri-
cresylphosphate - in all the samples sent to his lab.


"This proves that oil from the engine gets into the air and this is
what you have been breathing during this flight when you took your
sample," Van Netten said. The levels of the toxic chemicals found in
Panorama's investigation were very low - well within international
safety standards.


But they are still of concern to Van Netten.


Within the aviation industry, fumes have long been recognised as a
hazard. The worry is that long-term exposure to such chemicals in
the air could be particularly dangerous to the health of passengers,
pilots and crew. Numerous pilots and crew claim that they have
become ill from long-term exposure to contaminated air on board
aircrafts.


John Hoyte, from the UK, claims that he suffered for years from
Chronic Fatigue Syndrome (CFS) because of contaminated air in the
airplanes that he flew. As a practising pilot, Hoyte put his
exhaustion down to the anti-social hours he was working. At first he
assumed this was normal for a pilot, but gradually he began to
notice other symptoms.


He says bright lights would "jump around" and he found it hard to
focus, his speech was sometimes slurred, and he had difficulty with
memory and thought processing. He began to suffer from mild
depression as well.

Hoyte says he had heard about the oil fumes problem on the type of
planes he was flying, but for some reason hadn't connected it with
his ill health until he was invited to take part in some tests at
University College London. When his blood/fat tests showed some
troubling results and a measured cognitive deficit, Hoyte says that
he immediately knew what was causing his illness and that he would
never return to flying pressurised airplanes.

Instead, he set up the support and information group, Aerotoxic
Association (www.aerotoxic.org).

And Hoyte says he is very concerned because of the numbers of people
affected. "I am being inundated by aircrew and passengers who have
developed similar `mysterious' CFS-type ill health symptoms during
a `fume event' flight (where fumes leak into the cabin) and who then
suffer for many months or even years afterwards," he says.


"Most doctors not surprisingly diagnose a random viral infection or
depression and treat accordingly, but none of the passengers or more
worryingly, doctors seem to know anything about `aerotoxic
syndrome', which was first recognised in 1999.

"It is most depressing to hear from so many people with identical
issues when the dangers and effects of breathing oil fumes is so
well understood and almost certainly explains much so
called `mysterious' ill health." But all is not lost, as Hoyte says
the ways to fix this problem are not out reach. "Air filters,
alternative oils, fume detectors and new air technology are all
available, but the passengers must demand it, for their own health,"
he says.


So are airlines aware of the problem of toxic engine fumes in the
cabin and what do they propose to do about it?

We approached the UAE's two major carriers for comment. A
spokesperson for Emirates told 7DAYS: "This is an issue currently
being investigated by the scientific community. Emirates operates
one of the youngest fleets in the skies. We have an excellent
maintenance programme, and all our aircraft are fully certified to
the highest industry standards."


While, Thomas Clarke, a spokesman for Etihad Airways, said: "The
British TV investigation found that the chemical levels were very
low, and well within the international safety standards, in two
types of aircraft that are not in Etihad's modern state-of-the-art
fleet." Dubai-based aviation enthusiast, Michael Stokes, who boasts
of numerous pilots in his family, has spent the past few years
researching aero toxic fumes and how they might be contaminating
cabin air.

According to Stokes, most jet aircrafts in operation today are
vulnerable to leaks into the cabin. "Basically the BBC only did
research on two types of aircraft, the 146 and the Boeing 757.
Research has not been done on all jet aircrafts, just these two.
Only when the aviation industry undertakes a full and comprehensive
study will we understand this phenomenon further," he says.

"What is important to note is that most of the jets flying today are
the same generation of aircrafts that all use the same technology as
the planes the BBC tested.


"The technology is the same and they all currently utilise the same
fuel oil in their engines, so if the vulnerability is the seals on
the engine, then if the oil gets out of the engine and gets into the
bleed air intakes, you've got contamination, no matter what plane
your are flying," Stokes adds. "The Boeing 787, a new generation jet
that does not use bleed air, is the only aircraft that isn't
affected by this problem, but they are not yet in the air."


---------------------------------------------------------------------
-----------


MERCURY


---------------------------------------------------------------------
-----------


Your mouth speaks volumes about overall well-being

Dentists adopt unconventional treatment options
Chicago Tribune
United States
By Julie Deardorff | Tribune reporter

May 4, 2008
The last time Barbara Stepp of Homewood visited her dentist, she
told him about her ongoing kidney infection.

"He immediately plopped me down in the chair and started doing
acupuncture," said Stepp, 70.

Stepp's dentist, John Rothchild in Hoffman Estates, is a longtime
member of the American Dental Association. He uses the latest high-
tech equipment to take X-rays, remove teeth and whiten smiles.

But Rothchild's practice is based on a holistic philosophy that says
the health of your mouth can affect your entire body.
In addition to acupuncture, his integrative treatment portfolio
incorporates the use of mercury-free fillings, cranial therapy and
homeopathic remedies.

The ADA maintains that "silver" amalgam fillings, which contain
mercury that can leach into the environment, are not a human health
threat.

And it considers muscle testing (or applied kinesiology) techniques,
dental homeopathy and craniosacral therapy to be "unconventional"
and not yet supported by science. Dental acupuncture, meanwhile,
needs to be supported by a major research effort, the ADA says.

But mounting research supports what holistic dentists have long
believed: Although the mouth may not be the window to your soul, it
can reveal potential medical problems in other parts of the body,
including the heart, lungs and brain.

And as the connection grows stronger, dentists who focus on treating
the whole body as well as the teeth and gums—with prevention,
education and nutrition playing a central role—may one day assume
the role of a "primary care doctor."

"The ADA teaches brushing and flossing to control ever-present
disease," Holistic Dental Association President Tim Gallagher
recently wrote in the group's journal. "Instead, we teach brushing
and flossing to check effectiveness of cellular immunity."

More than 75 percent of Americans over age 35 have gum or
periodontal disease, an infection that can trigger an inflammatory
response not just in the gums but throughout the body.

Researchers first noticed a relationship between gum disease and an
increased risk of heart attack in 2000. Now periodontal disease is
linked to nearly a dozen systemic illnesses, including an increased
risk of stroke or a respiratory infection; an increased risk of
delivering pre-term, low-birth-weight babies; and difficulty in
controlling blood sugar levels in diabetics, according to the
National Institutes of Health.

"Bleeding gums are a sign of chronic inflammation, which is the
basis of all disease," said Westmont dentist Ron Schefdore, who uses
a skin-prick blood test to screen his patients for blood glucose
level, cholesterol and C-reactive protein, a marker for heart attack
risk. If he finds something suspicious, he refers the patient to a
physician.

In many cases, holistic practitioners are conventionally trained
dentists who are interested in a larger picture of health. But they
range from conservative to radical.

Some of the more controversial ideas stem from the work of Dr.
Weston Price, a dentist and author of the 1939 book "Nutrition and
Physical Degeneration." Price, a harsh critic of modern
civilization, said that both root canals and amalgam fillings should
be avoided and advocated a diet of nutrient-dense whole foods.

But many dentists who advocate holistic approaches are less extreme.

"A lot of what I've heard holistic dentists advocate is what most
dentists should already be doing," said Chicago dentist Robert
Brandstatter. "At our office, we try to prevent dental diseases by
explaining how overall behaviors to the whole body, such as drugs,
medications, nutrition and smoking can affect the teeth."

Other "alternative" dentists might use biocompatible dental
materials, natural products such as herbal toothpastes and mouth
rinses as well as herbal or homeopathic remedies for pain,
irritation and infections.

"Homeopathy doesn't work for everyone, but for those it does, it can
relieve anxiety and pain, especially from trauma after dental
procedures, injection or extraction," said Chicago dentist Taf
Paulson, a trained psychotherapist with a degree in nutrition and
chemistry.

"We use as conservative a treatment approach as possible," said
Paulson, who emphasizes preventive techniques and offers creative
visualization, aromatherapy and local anesthesia alternatives.

Other pain control and relaxation techniques include acupuncture,
hypnosis and massage therapy.

Stepp, a corporate consultant and communications trainer, found
Rothchild after experiencing severe pain from a locked jaw. She saw
three Chicago-area dentists and they all told her she needed major
surgery at a cost of around $25,000.

Rothchild took a different approach. After checking how her bite
affected the rest of her body structure and jaw, he made an
appliance to correct her bite and "balanced her system" by using
both cranial osteopathic theory and acupuncture to help with pain.

He also did some Reiki energy work, all methods that critics of
holistic or biological dentistry say are based on "quack concepts."

Stepp, however, who flies from her part-time home on San Juan
Island, Wash., to see Rothchild, couldn't care less.

"I believe in results," she said. "I've repeatedly watched this work
and experienced it. I know my jaw doesn't lock, my bite is fine and
I don't have the headaches. That's good enough for me."

Besides, she said, "putting aside the holistic side of his practice,
he's a brilliant dentist to begin with. He simply added holistic
methods to his extensive skill base."







Thank you for supporting Hadcorp.

http://www.freewebs.com/implants/

The following letter is now posted on the `Consumers for Dental
Choice' website

We Win -- FDA Must Classify Mercury Fillings

We have won our ten-year battle to get the Food and Drug
Administration to comply with the law and set a date to classify
mercury amalgam.

On Monday, we settled our lawsuit, Moms Against Mercury et
al. v. Von Eschenbach, Commissioner, et al. FDA will finish
classifying within one year of the close of the public comment
period on its amalgam policy, that is, by July 28, 2009.

There's more good news. During a several hour negotiation
session, FDA agreed to change its website on amalgam --dramatically.
Gone, gone, gone are all of FDA's claims that no science exists that
amalgam is unsafe, or that other countries have acted for
environmental reasons only, or that the 2006 Scientific Panel vote
affirmed amalgam's safety. Instead
-- see http://www.fda.gov/cdrh/consumer/amalgams.html -- FDA has
moved to a neutral course, while recognizing the serious health
concerns posed by amalgam in particular for children and unborn
children, for pregnant women, for those with mercury immuno-
sensitivity or high mercury body burdens. FDA now states, for
example:

"Dental amalgams contain mercury, which may have neurotoxic effects
On the nervous systems of developing children and fetus."�

"Pregnant women and persons who may have a health condition that
makes
them more sensitive to mercury exposure, including individuals with
existing high levels of mercury bioburden, should not avoid seeking
dental care, but should discuss options with their health
practitioner.�"

Perfect? No. A 180-degree reversal from FDA's 30-year policy of
protecting mercury fillings? Absolutely.

To change FDA policy, we tried petitions, Congressional
hearings, state fact sheet laws, Scientific Advisory Committee
hearings, and letters galore -- to no avail. So in the great
American tradition, we sued. The case came to a head this spring. On
April 22, working with Johann Wehrle and Gwen Smith, I filed a
motion for an injunction before Judge Ellen Huvelle. Three sets of
briefs later, the government and I presented our oral arguments on
May 16. In a crucial ruling, Judge Huvelle ruled that our 11
plaintiffs -- the diverse group listed below -- have standing. She
said FDA should classify, and invited the two sides to mediate. On
May 30, before Magistrate Judge John Facciola, Bob Reeves (who flew
in from Lexington KY) and I hammered out an agreement with FDA
officials and lawyers.

The impact of the re-writing of its position on amalgam can
hardly be understated. FDA's website will no longer be cited by the
American Dental Association in public hearings. FDA shows awareness
of the key issues involved. As it prepares to classify amalgam, FDA
has moved to a position of neutrality. Indeed, having repeatedly
raised the question of amalgam's risk to children, young women, and
the immuno-sensitive persons in its website, I find it inconceivable
that FDA will not in some way protect them in its upcoming rule.

Charlie Brown

3 June 2008

PS 1: Our talented (and pro bono publico) legal team includes
Consumers
for Dental Choice president Sandy Duffy, Bob Reeves, Johann Wehrle,
Sandra
Keech, Mike McClory, and Gwen Smith; Larry Pilot served as legal
advisor
on the FDCA.

PS 2: Great appreciation to our gutsy plaintiffs, a team of four
nonprofit groups, two public officials, three dental professionals,
and
two consumer victims: Moms Against Mercury (Amy Carson and Angela
Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark
Mitchell), Oregonians for Life (Mary Starrett), mercury expert
Michael
Bender (in his capacity as Commissioner of a Vermont advisory board
on
mercury), Arizona Senator Karen Johnson, Dr. Andy Landerman, Dr.
Corrie
Crowe, dental assistant Karen Palmer, consumer advocates Linda
Brocato
and Anita Vazquez Tibau, and (of course) Consumers for Dental
Choice.

Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002
Ph. 202.544-6333; fax 202.544-6331
charlie@..., www.toxicteeth.org


---------------------------------------------------------------------
-----------


More Dental Amalgam News:

Send your comments to the FDA about the hazards associated with
dental amalgams. The deadline is July 28, 2008.

Communication may be sent via the following methods of transmission:

1. Fax

(301) 827 6870


2. Electronically

http://www.regulations.gov.
In the search box enter: FDA-2008-N-0163


3. Mail

Division of Dockets Management (HFA-305)
FDA
5630 Fishers Lane, Room 1061
Rockville, MD 20852


---------------------------------------------------------------------
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Medical Device News


---------------------------------------------------------------------
-----------


Dems Readying Liability Legislation

Wed. Jun 4, 2008


Democrats rankled by a recent Supreme Court decision shielding
medical device companies from state liability lawsuits plan to
unveil legislation to reverse the ruling, the first of many expected
efforts to chop away at federal rules that restrict consumers'
ability to sue.

House Energy and Commerce Health Subcommittee Chairman Frank
Pallone, D-N.J., and House Oversight and Government Reform Chairman
Henry Waxman will introduce legislation before the Independence Day
recess that would explicitly state that FDA regulation does not
trump medical device patients' ability to seek damages under state
law, a Pallone spokesman said.

The two were spurred to act after the Supreme Court ruled in
February that patients injured by defective medical devices cannot
sue for damages in state courts if the FDA approved the marketing of
the product.

The justices found that the 1976 Medical Device Amendments pre-
empted the right of injured patients to sue for damages in state
courts against the most complicated or high-risk devices that
undergo FDA's strictest approval process. Justices are in various
stages of weighing pharmaceutical preemption cases.

Moreover, the issue has revved up the long-standing rivalry between
trial lawyers and big-business lobbying groups, this time over the
issue of how far can federal regulatory agencies go in preempting
states on all sorts of consumer and product liability laws.

With Democrats in control of Congress, the trial bar senses an
opportunity to play offense after having to fend off attacks during
12 years of Republican control.

Trial lawyers have started to target issues on a case-by-case basis
where they sense that preemption has run amok to the detriment of
consumers who are unable to seek redress in the courts. They contend
that pre-emption does not allow corporations to be held fully
accountable for faulty products in the same way that the threat of a
massive lawsuit does.

Their first legislative bid will be on the recent Supreme Court
ruling in favor of Medtronic Inc., which produced a heart catheter
at the center of the case. The device burst during a 1996
angioplasty.

"It basically threw out all the medical device cases in the country
based on the wrong supposition that compliance with the device act
constituted preemption of state tort law remedies," said Linda
Lipsen, senior vice president for public affairs for the American
Association for Justice, the primary lobbying group for trial
lawyers.

Democrats came down on the side of the trial lawyers and immediately
blasted the Supreme Court's decision. Senate Health, Education,
Labor and Pensions Chairman Edward Kennedy, Pallone and Waxman all
said Congress never intended when it passed the 1976 medical device
law to give medical device manufacturers blanket immunity.

Democrats attempted last summer to preserve patients' right to sue
despite FDA regulation in legislation that would have given the
agency additional drug and device oversight authority. Republicans
quickly squashed the effort after billing it as a gift for trial
lawyers.

Given the dwindling legislative calendar this year, particularly
with the November elections looming, any measure introduced will
have to fight for time on the floor. It is likely to frame the
debate for the 111th Congress, particularly if Democrats add to
their legislative majorities in the House and Senate and especially
if a Democrat wins the White House.

"Patients hurt by defective drugs and medical devices would no
longer have the ability to seek compensation for their injuries.
This doctrine is known as preemption," Waxman said during a hearing
last month on issue. "The result is that one of the most powerful
incentives for safety -- the threat of liability -- would vanish."

The U.S. Chamber of Commerce's Institute for Legal Reform is
fighting efforts to deny preemption, noting that federal law should
trump state statutes when there are inconsistencies between the two.
It further argues that preemption allows companies that conduct
business in different states one set of rules for compliance,
instead of a hodgepodge of laws that stifle growth.

"I think they have articulated for a long time the weakening
preemption at the federal level," said Lisa Rickard, president of
the institute. "They have highlighted this in their magazines and
their conferences," she said, referring to the American Association
for Justice.

Opponents rely on an old standby: bashing the trial bar. At the
urging of business leaders, Republicans targeted trial lawyers when
they were in control, passing legislation that limited class-action
suits and restricted bankruptcy filings.

They argue that preemption is narrowly tailored in response to high
court damages that threaten to wreak havoc on the medical and
pharmaceutical fields as well as other sectors.

"Current preemption policy is nothing novel or radical, but a
dynamic response to an increasingly litigious environment that
undermines the effectiveness of the long-established FDA regulatory
system," said House Oversight and Government Reform ranking member
Tom Davis.

The trial bar argues that the Bush administration has instituted the
preemption strategy to an unprecedented degree, noting that since
2005 federal agencies have issued 51 different rules that have
preempted state law. The FDA and the National Highway Traffic Safety
Administration issued most of the rules, but they also came from
smaller agencies such as the Federal Railroad Administration.

For example, NHTSA is in the process of finalizing a rule before the
end of the month that would institute new requirements for car roofs
in an attempt to reduce injuries and death from rollover crashes,
where 10,000 people die annually and another 24,000 are seriously
injured.
A preliminary rule would allow preemption of state law on product
liability suits if carmakers met the NHTSA standard.

One critic, David Vladeck, a Georgetown University law professor,
said that he is concerned with NHTSA's position given that the
federal statue it operates under contains a "savings clause" that
says compliance with the agency's standard does not exempt a
business from liability on the state level.

The Senate Commerce Consumer Affairs Subcommittee will hold a
hearing on the proposal today.

"If they don't succeed in the legislature, they will go to the
regulatory process," Lipsen said of the business lobbyists. "They
are asking these regulatory agencies when they address rules on
safety that if you are injured by one of these products, your case
is pre-empted. ... It's really a whack-a-mole process."

by Bill Swindell and Anna Edney




Thank you for supporting Hadcorp.

http://implants.webs.com/

Sarah Schmidt ,  Canwest News Service
Published: Friday, May 16


OTTAWA - The federal government announced Friday it intends to slap
a
toxic label on a bunch of chemicals used in everyday products from
chewing gum to cosmetics as well as in controversial devices like
silicone breast implants because they are either harmful to human
health or the environment.


The 11 chemicals include Vinyl acetate, a carcinogen used as a base
in
chewing gum, and Cyclohexasiloxane, used as building blocks of
silicone used in breast implants.


If industry fails to offer new information within 60 days to reverse
course, Ottawa will classify these chemicals as toxic and kick start
a
process that could lead to a ban in certain products, as with
bisphenol A in baby bottles.


Silicone breast implants were pulled from the market in Canada in
1992
amid concerns they were unsafe for women. In 2006, they were once
again made freely available.


In the case of the synthetic chemicals belonging to the
Cyclohexasiloxane family - D4, D5 and D6 - the government is
proposing
an additional step to ensure their virtual elimination from the
environment.


In addition to being found in silicone fluids, these synthetic
chemicals are found in cleaning compounds, cosmetics and personal
care
products, including shampoos, creams, lotions, and antiperspirants.
D5, in particular, is a common ingredient to give products a silky
texture.


The government concludes these synthetic chemicals do not pose a
risk
to human health, but rather should be declared toxic to the
environment.


"Canadians expect their government to protect the environment from
harmful chemicals, and that's why we are taking action," said
Environmental Minister John Baird.


Six of the 11 chemicals are flagged as toxic to human health; the
government said it will work with industry to reduce exposures to
two
of these substances.


The health toxins are: Vinyl acetate, used in food additives,
paints,
sealants and plastics; C.I. Pigment Yellow 34 and Red 103, a
colourant
used in paints, dyes, inks, and plastics; Thiourea, used in
electronic
products, insecticides and textiles; isoprene, used in rubber and
plastic manufacturing; and Oxirane, used in paints, coatings and
adhesives.


The announcement comes after a lengthy review of the chemicals under
the government's Chemicals Management Plan involving about 200
substances. It is the most comprehensive chemical review currently
being undertaken in the world.


Mike Patton, spokesman for the Canadian Cosmetics, Toiletries and
Fragrances Association, praised the process and welcomed the
conclusions.


"There's nothing in this batch that poses a health concern for us.
But
our other interest is environmental impact, and we'll work with the
government to minimize or eliminate entirely any environmental
impact."


Thiourea, a carcinogen, used to be a common ingredient in
personal-care products, but it hasn't been used by the industry for
some time, said Patton.


Women health advocates say they'll use this new information to push
for a review of the October, 2006, lifting the ban on silicone
breast
implants.


The government's newly released risk assessment of D4, found in
silicone breast implants, states the synthetic chemical impairs
fertility. It also flags a finding of the Danish Environmental
Protection Agency, identifying the liver as a "target organ for D4
exposures."


But the government concludes the substance "is not entering the
environment in a quantity or concentration or under conditions that
constitute or may constitute a danger in Canada to human life or
health."


Madeline Bosco, a nurse who is executive director of Canadian
Women's
Health Network and public appointee to the government's advisory
committee on breast implants, says research shows silicone is not
well-contained in the implants and diffuses throughout women's
bodies.


"This is extremely good news from my perspective. It helps move the
toxicology world, which has already been raising questions about
silicone, into the health products process."


Epidemiologist Diane Zuckerman, president of the National Research
Center for Women & Families based in Washington, characterized
Health
Canada's decision "confusing and illogical. If D4 is dangerous to
the
environment, on what basis is the government concluding that it is
not
dangerous when implanted inside the human body or repeatedly used on
the human body?


"A more accurate assessment would have been to say that the health
hazards are unknown for individual use of products with D4, because
they have not been adequately studied. I would think that women of
childbearing age would be especially concerned about having breast
implants because of possible infertility problems that could result
from D4."


Silicone implants were pulled from the market in Canada in 1992 amid
concerns they were unsafe for women. In October, 2006, Health Canada
changed course and made them freely available to women with the
caveat
that "no medical device is 100 per cent safe."


Until then, only breast implants filled with saline were licensed
for
sale in Canada.


The October, 2006 decision came just months after Health Canada's
scientific advisory committee said questions "had not been
sufficiently addressed" about potential health risks should the gels
bleed or leak into women's bodies and about whether the implants
increase the risk of auto-immune diseases in the long term.


The government is also proposing to list Acid Blue 80, a colourant
used in cosmetics and glass cleaner, as toxic to the environment.



This is the reason health canada will fight to have these chemicals
only onsafe for the enviroment they have a pending class action
lawsuit that we filed against them and they approved the implants
only because of this lawsuit they needed to be able to make people
believe implants were safe so the medical device department will
fight this tooth and nail.

Sandra

Regulatory Approval
One-third of panel on breast implants declares conflict
Laura Eggertson
CMAJ

Three of the 9-member Health Canada advisory panel studying silicone
breast implants were paid advisers to one of the 2 companies seeking
to have their medical devices reinstated in Canada or had expenses
paid by a company at a seminar or meeting.



Figure. Manufacturers of silicone breast implants are vying for
Health Canada approval. Photo by: CP



Inamed Corporation and Mentor Corporation have submitted 6
applications to Health Canada for silicone breast implants. The
panel will provide "scientific, medical and clinical advice on
current and emerging issues related to safety and effectiveness of
breast implants" to the House of Commons Standing Committee on
Health.

Silicone breast implants were withdrawn from the Canadian market in
January 1992 after litigation and safety concerns. On Apr. 12, 2005,
a US Food and Drug Administration (FDA) advisory committee
recommended that Mentor's implants be allowed back on the US market.

As per Health Canada requirement, panel board members completed
conflict of interest statements. Only after repeated media requests,
Health Canada provided copies of the panel members' declarations of
conflict of interest.

Inamed paid panel member Michael Brook as an independent expert to
advise the company at a US FDA panel meeting in Washington in
October 2003 to consider relicensing the devices. Brook is a
professor of organosilanes and silicones at McMaster University in
Hamilton.

"I provided an independent and expert interpretation of the data,"
Brook wrote in his conflict declaration to Health Canada.

Another panel member, Dr. Mitchell Brown, indicated that he had
participated in seminars or promotional meetings that dealt with
Mentor and Inamed breast implants. The plastic, reconstructive and
cosmetic surgeon at Toronto's Sunnybrook and Women's College Health
Sciences Centre also attended conferences and meetings where "all or
part of the travel and accommodation costs were provided by Mentor
and Inamed or a subsidiary."

A third panel member, Harry Brandon, stated that he had received
research grants from Mentor and Inamed or a subsidiary in the last 5
years and had participated on committees advising Mentor and Inamed
on their implants. He has also participated as a principal
investigator in scientific studies related to those implants.
Brandon is an affiliate professor of mechanical engineering at
Washington University Schools of Engineering and Medicine in St.
Louis, Mo.

In June, the House of Commons Standing Committee on Health asked
Health Minister Ujjal Dosanjh to delay any findings on the 2
companies' licensing applications until the committee could conduct
its own investigation into the subject.

Bloc Québécois MP Nicole Demers pushed the Health Committee to ask
for the minutes and transcripts of the advisory panel's in-camera
meetings of Mar. 22 and 23. Although Robert Thibault, Dosanjh's
parliamentary secretary, agreed in mid-May to provide the minutes,
by mid-June the committee had not yet received them.

In addition to receiving the minutes, Demers would also like to
observe the meetings. "It would be a real tragedy for all Canadian
women if we were to agree to reintroduce silicone breast implants."

Demers, who is a breast cancer survivor, says she is concerned about
the makeup of the advisory panel and the declared conflicts of the 3
panel members.

A public forum about silicone gel-filled breast implants will be
held in Ottawa on Sept. 29 and 30. "We are taking the very best
information and advice we can find and we'll take whatever time is
required to make the right decision for Canadian women," Dosanjh
said.

I think we even had a nurse on this panel who claims to think
implants are not safe.


HEALTH CANADA

NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES

*************************
Health Canada grants manufacturers Class IV licences with conditions
to market silicone gel-filled breast implants

OTTAWA - Health Canada announced today that it will grant licences
with conditions to Inamed Corporation and Mentor Medical Systems to
market their silicone gel-filled breast implants in Canada.

These Class IV licences are conditional on the manufacturers meeting
several requirements to ensure their devices continue to meet the
safety and effectiveness requirements of the Medical Devices
Regulations.

Health Canada's number one priority is to protect and promote the
health and safety of Canadians.

Decisions to grant licences for medical devices are strictly
objective and based on evidence. Applications from Inamed and Mentor
were evaluated by Health Canada's scientific and medical staff to
determine if the devices met safety and effectiveness requirements.

Health Canada's decision followed a complete review of the
manufacturers' evidence, independent evidence-based studies, public
submissions and an Expert Advisory Panel's advice.

The Expert Advisory Panel reviewed submissions from concerned
Canadians and heard directly from the public at an open meeting
before it provided its advice to Health Canada.

In granting these licences, Health Canada has attached several
conditions. The manufacturers are required to:

Provide ongoing updates regarding long-term clinical trial results
through to ten years.

Conduct and report on at least two patient focus groups in Canada to
determine the effectiveness of product labelling.

Conduct a large, long term study involving tens of thousands of
women.

Manufacturers are required to start the study within one year.

Survey Canadian plastic surgeons on the effectiveness of the
labelling and decision aids (brochures) provided with the implants.

Continue implant retrieval and analysis studies - from all available
sources - for further characterization of potential modes and causes
of implant failure.

In addition, the manufacturers have committed to the following

- provide updated sales and marketing histories - including a
summary of any reported problems or recalls - in Canada and
internationally

- provide implant registration cards with the device (Patients
receiving these cards from their surgeons can send them voluntarily
to the manufacturer. This will allow the manufacturer, in addition
to using general methods of dissemination, to distribute any new
information directly to the persons affected.)

Until now, only saline-filled breast implants have been licensed for
sale in Canada.

Silicone gel-filled implants have been available through the
Department's Special Access Programme for Medical Devices.

In announcing this decision, Health Canada reminds Canadians that no
medical device or drug is 100-per-cent safe, effective and without
risks.

Silicone gel-filled implants are considered a Class IV medical
device, representing the highest degree of potential risk.

A woman's decision to undergo breast reconstruction after a
mastectomy or for breast augmentation should be made only after
consultation with a health care provider and full consideration of
the benefits versus any potential risks.

Note: Summary Basis of Decision documents regarding the Inamed and
Mentor applications are available at the Health Canada Web site

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-
breast-mammaire/index_e.html

*************************
Statement of Dr. Diana Zuckerman, president, National Research
Center for Women & Families

WASHINGTON, Oct. 20 - After more than a dozen years of limiting
access to silicone gel breast implants, Health Canada today
announced that it was granting licenses to two companies, Mentor and
Inamed, to sell these products for breast augmentation or
reconstruction.

The following is the statement of Dr. Diana Zuckerman of the
National Research Center for Women & Families:

"This shocking and unfortunate decision will jeopardize women's
health for many years to come. In addition to the impact on
individual women, this ill-advised decision will create a financial
strain on the Canadian health care system.

"A Canadian study by Aleina Tweed and her colleagues in British
Columbia indicated that augmentation patients are hospitalized more
often and for longer periods of time than other Canadian women of
the same age.

"Will Health Canada pay for regular MRIs to determine if women's
silicone gel breast implants are leaking? Will Health Canada pay for
immediate removal of breast implants for women whose implants are
leaking silicone into their bodies? If they don't, they are turning
their backs on women whose health could be irreparably harmed by
today's decision. If they do, it will cost Health Canada many
millions of dollars that could otherwise be spent to fight deadly
diseases.

"Last week, very serious new allegations were made by a chemist who
worked at one of the companies, Mentor Corporation. Health Canada
appears to be indifferent to these and other allegations by Mentor
scientists who have come forward to explain how the company provided
inaccurate safety information about their breast implants.

"Although Dr. Sharma stated during today's press conference that
Health Canada was aware of the allegations, it seems that she was
referring to allegations made last year, not the ones made last
week."

Dr. Sharma stated during the press conference that Health
Canada "can and will revoke the licenses if the required conditions
are not met" or if other information comes to light about safety
concerns.

Dr. Zuckerman has contacted Health Canada to urge them to
immediately look into the allegations questioning the integrity of
Mentor's safety data.

Meanwhile, the FDA is being urged by several organizations and
individuals to investigate these allegations before making a
decision in the U.S.

The licenses are contingent on five conditions, most of which
require additional research.

Since the companies have not conducted well-designed
long-term studies in the more than 40 years that breast implants
have been on the market, Zuckerman believes that "it is naive of
Health Canada to think that this research will be appropriately
conducted and completed after granting a green light to the
companies."

"It is especially shocking that Health Canada is granting licenses
prior to meeting the conditions of approval regarding the use of
focus groups to test labels that ensure informed consent for
patients. Moreover, they do not even require a registry, as was
recommended by their advisory committee. We would consider a
registry a minimum safeguard."

The National Research Center for Women & Families is a nonprofit
research and education organization that focuses on health and
safety issues.

Dr. Zuckerman is an epidemiologist and former Congressional
investigator, and can be reached at dz@...

I found this so sickening I had to post it.Imagine being forced to a
hospital and forced to have an abortion and we deal with china in
the western world go figure I would say think about this poor woman
next time anyone buys a made in china item in any store. My dad has
for years refused to purchase anything made in china he is so right.
My dad has always said if we buy there stuff we are aiding in the
human rights tragedy there and the slave labour.
Sandra


RIGHTS ACTIVISTS IGNORE CHINA'S ONE-BIRTH POLICY Tue May 27, 7:57 PM
ET


Death tolls from the Chinese quake now top 65,000. Hollywood's
Sharon Stone wonders aloud whether "karma" explains the tragedy
because (she said) the Chinese are "not nice to the Dalai Lama, who
is a good friend of mine."



Amnesty International reports hopes are fading that the Beijing
Olympics may lead China to reform, warning in an April report: "It
is increasingly clear that much of the current wave of repression is
occurring not IN SPITE OF the Olympics, but actually BECAUSE OF the
Olympics."

But to me the most shocking reminder of how horrifying the Chinese
government remains lies latent in this week's headlines: "One-Child
Policy Has Exceptions After China Quake," as the Associated Press
wrote.

Families with only one child killed in the earthquake "can obtain a
certificate to have another child, the Chengdu Population and Family
Planning Committee in the capital of hard-hit Sichuan province
said."

The government will give you a certificate so you can have another
child? How big of them.

Tibetan Buddhists have their friends in Hollywood, and the
international human rights community still frowns on torturing
political activists. But China's brutal oppression of women's bodies
and basic disrespect for human life generates a collective yawn in
the Western human rights community.

Throw an AIDS/HIV activist in jail? International outrage,
naturally. But who really cares about the right of an ordinary
Chinese woman to have her baby?

Chinese population policies spawn an ambivalent (at best) reaction
in the West because so many agree with the goal, they tend to
downplay or ignore the means.

In China the government owns everything, including women's bodies.
Women must apply to their work unit for permission to get pregnant,
and whole groups can be punished if one woman gets "illegally"
pregnant. The "illegally born" are a serflike caste who can be
denied equal access to a whole host of government services necessary
for life under communism. "One Extra Birth, Whole Family
Sterilized," warns a government propaganda poster (examples of which
are collected and translated by the Laogai Research Foundation).

How does this "policy" work? One woman, a Muslim ethnic Uzbek in
China named Mahire Omerjan, testified to the Laogai Research
Foundation what it was like to "illegally" conceive her second child
in the 1990s.

"Those at our company who were in charge of our planned birth knew I
was pregnant. ... A few months later, they said, 'You can't have
this child. It's not in keeping with the spirit of related
documents.' ... 'I'm five months pregnant. We have our religious
faith. By our religion, abortion is not permitted. It's a crime,"
Mahire replied.

The company bureaucrats didn't care.

Mahire pointed to laws permitting ethnic minorities to have more
than one birth, pleading for her baby's life: "Many times I spoke
with my bosses, requesting permission to have the child."

Alas, policies were violated; action must be taken.

"Finally, my unit decided to take me by force to the hospital for an
abortion. I was then six and a half months pregnant."

Company officials tried to get Mahire to see reason: "'If you don't
do what we want, we'll suspend your wages, cancel your bonuses, levy
a 2,500 RMB penalty on you, suspend all benefits you are enjoying
now. And your child will never have a residence permit. He'll be a
nobody.'"

This is what a "non-forced abortion" in China looks like.

In the end, three company officials showed up at Mahire's house with
a Nissan van and drove her to the hospital. When she saw the needle
they were about to insert into her belly, "I told the
obstetrician, 'Doctor, don't give me the shot. I want to go home. I
want my child!' ... But the two nurses started pressing my arms with
all their might. One of the nurses said ferociously, 'Who told you
to get pregnant! Who told you not to act according to the planned
birth policy!'"

Remember Mahire when you read about other human rights violations in
China and when you watch the world's athletes come together in
Beijing this spring.

I was going to put the Obituary on here for Linda she lost her fight
with cancer and I have decided I will have a tribute put on the
Canadian connection site for her.

I had sent it to a couple of sites but was informed that some women
were upset as with the posting of it, they acted, "some of the
women" like who cares, so to honor a woman who was not arrogant or
self centred and even in her last days thought only about other
people I feel it would only be right that I have Tony put a tribute
to her on CC Site.

To the women who were upset at the ignorance of some women well all
I can say is that some people are so full of themselves that they
can't see beyond themselves nor do they want to some feel everything
revolves around only them and that they are the only ones who are
ill.

The ones who complain like this are the ones that made Linda and the
women like her so special. There is many women on this site actually
all of you who don't do this and I am so grateful some sites well
take them for what they are. Whining gets you no where action does
and that is what some sites are about.

The ones who disrespected her Obituary  by making it about you well
shame on you.

I will let everyone know when I have sent the tribute to Tony to
post on Linda and I will post the link on here.

Thanks for pointing out to me what was upsetting some of you that
saw the posts.

Sandra

Donda West's Plastic Surgeon Arrested on DUI Suspicion

TheCelebrityCafe.com

Valley Stream, NY, USA

26-Jun-2008

Written by: Angela Flournoy

The surgeon operated on Kanye West's mother hours before her death.

According to AP News, Dr. Jan Adams was arrested on suspicion of
drunken driving, early Thursday morning, by police officers in
Northern California. Adams performed several cosmetic procedures on
58-year-old Donda West, mother of hip-hop artist Kanye West, the day
before she died of heart disease and complications from surgery,
last November.

California Highway Patrol pulled over the surgeon in Vallejo, after
motorists reported his gray Jaguar driving the wrong way on the
freeway, the AP reports. Adams was also arrested for driving on a
suspended license from a prior DUI charge.

The author of several books on plastic surgery has paid more than
$775,000 in civil settlements from four malpractice lawsuits whose
dates range from 2001 to 2007. Debbie Nelson, an analyst with the
state medical board, told the AP that Adams was operating on a
temporary 150-day license due to unpaid alimony or child support,
but that license expired Wednesday night.

Adams appeared on CNN's Larry King Live in January and said that his
practice was "nearly destroyed" by the media fallout as a result of
Ms. West's death. Prior to the tragedy, Adams had appeared on shows
like Oprah and Entertainment Tonight, in addition to hosting the
television series, Plastic Surgery: Before and After for five years.

Mr. West recently announced the construction of a literacy center in
Sierra Leone in memory of his mother.


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http://implants.webs.com/

Hello Sandra laliberte,

You are receiving this email because you have subscribed to our e-
newsletter.


Vietnamese woman dies after breast implant surgery

Jun 25, 2008, 5:53 GMT

Hanoi - A Vietnamese waitress has died after undergoing silicone
breast implant surgery at an unlicensed clinic, officials said
Wednesday.

Dinh Thi Thu, 30, died late Monday after being treated for two days
at the Rach Gia General Hospital in Kien Giang province, 250
kilometres south-west of Ho Chi Minh City, according to the director
of the hospital Pham Van Dom.

Dom said Thu had been admitted last Saturday suffering high fever,
nausea and postoperative shock. She died whilst being taken to a
hospital in Ho Chi Minh City after her symptoms worsened.

'She had this surgery at an unlicensed clinic in the province a week
ago and we suspect that it was the surgery which caused her death,'
Dom said.

Local newspaper Tien Phong said Thu had paid the surgeon 1.8 million
dong (108 dollars) for the operation.

A local police officer said the police would probably launch a
criminal investigation into the case once the autopsy results were
available.
Ngo Quoc Tan, who is in charge of the autopsy, said the results will
be available next week.

In 2006, a 34-year-old woman died after undergoing breast surgery at
her house in Ho Chi Minh City. She died after the freelance surgeon
injected an unidentified liquid into her breasts. Plastic surgery
has been under increasing scrutiny after several deaths in recent
years were linked to unlicensed breast implant operations.

Despite an annual per-capita income of more than 900 dollars,
Vietnam has seen an increase in plastic surgery, especially in
booming Ho Chi Minh City, which alone has more than 40 clinics
licensed to perform nose jobs, chin implants and lip enhancements.


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Beauty Marks

6/26/08

1:00 PM

Gross News of the Day: YouTube Hosts Thousands of Plastic-Surgery
Videos

New York Magazine

NY, USA


The next time you get a boob job, a face-lift, or Lasik eye surgery
you could save a few bucks if you agree to have your surgery filmed
and then posted on YouTube. Yes, some doctors offer discounts for
posting videos because they serve as little online commercials for
them. In fact, you'll find around 2,400 videos of Botox procedures
alone on YouTube. Michelle Wilder posted a video of her Lasik
surgery.

According to the New York Times, this is what she got in return:
Dr. Chynn offered either a free Botox injection worth $400 or a $100
discount on the $5,000 Lasek operation, which, unlike Lasik, doesn't
entail cutting a flap in the cornea.

"I thought it was a little odd, because I was wondering `Who wants
to see my surgery?' " said Ms. Wilder, 25, a Manhattan accountant.

No one. (Or perhaps a few people with iron stomachs.) Aside from
this rubbing us in all the wrong ways because it's gross and
unethical, we just don't see how it's an effective form of
advertising. We hate our contacts, so we tried to watch this video
of YouTube user jackdakota's Lasik eye surgery. Except we couldn't
even make it past the first 30 seconds, which is not even close to
the first incision. We were creeped out even more by the ominous,
old-school-techno background music that seemed to say, "Uh-oh! We're
cutting open eyeballs!" But also, if we were seriously shopping for
Lasik, we wouldn't turn to a YouTube video to help us find a doctor.
We mean, how do we know if they're doing a better job than the guy
in the other video? Sorry, we just lost our lunches, as, we're sure,
did you.


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Facing a plastic surgery-free future

Jamestown Press

RI, USA

Flotsam and Jetsam

By Donna Drago

Am I the only one who likes my own face?

As faces go, it's not a great one, but it's certainly a good,
perfectly adequate face. Everything functions well.

One of the things I like about my face is that when I look at myself
in the mirror, I see a mosaic of people who came before me. When I
look at my kids' faces, I see a little of me. I like that. Faces
should reflect so me of th e history of the owner.

That, sadly, is changing.

Look in fashion magazines, in the Yellow Pages- just look at the
sheer number of plastic surgeons, "medical-spas" and "rejuvenation
centers," of all kinds.

Listen to the radio commercials that entice with language
like "you'll be a brand new woman," or "let us help you find the
real you."

The way I see it, the constant tweaking, nipping and plumping that's
going on is bad for all of us- on many levels.

First, let's talk about me. I have no desire whatsoever to have
plastic surgery or "procedures," of any sort. The notion of being
injected with Botox- the same toxin that is a food poison when you
don't seal the jars of tomatoes correctly- makes me squirm. My
reluctance to getting a new face would be okay except for one thing-
the more women that have plumping injections, face lifts, nose jobs,
the more likely it will be that those of us who want to age
naturally will look like ancient, craggy crones. Someday, when pert,
smoothskinned women appear on TV and in ads saying "this is what 70
looks like," and I actually look 70, I'll be sunk.

Plastic surgery is confusing to children. There's even a new book
out helping kids cope with having a Mommy with a new face. If they
have to learn to cope, there's something wrong with the situation.

In the old days, relatives went to visit a mother and new baby and
exclaimed, "She looks just like her grandma." Fast forward a few
years and the same wellintentioned people will exclaim, "She looks
just like her grandma did before she got the new nose and chin."

Imagine the experience of looking at old family photos. Comments
like "This is what Aunt Shirley used to look like," and "When Grammy
was small, she had a funny chin and now she doesn't anymore," will
be the norm.

People have physical imperfections and attributes that make them
unique. Imagine if everyone with a big, bulbous nose got rid of it.

What would cartoonists draw if nobody's ears stuck out? What if
everyone got rid of their freckles? What if no one had "smiling
eyes?" We'd all end up like that featureless little alien that
allegedly landed at Roswell, N.M.

There was a time when only women of a "certain age," considered face
lifts, brow lifts and other procedures. Now, it's not unusual for
women in their twenties to buy into the hype and start on a long,
painful path toward some skewed idea of perfection.

This is going to upset some people, especially those who recently
spent enough on their faces to purchase a small sailboat, but here
it goes: you just don't look that great.

Every time I see someone who's had work done on their faces, all I
can think is that they could all be cousins to Joan Rivers-
everybody looks the same.

Imagine this scene: walking in to your 50th high school reunion and
seeing that everyone looks like everyone else. How would you find yo
ur ni nth gr ade crush? How many people would you walk up to before
you got the one you were looking for? Would you even bother?

What's the deal with the Hollywood celebs? Does anyone really want
lips like Goldie Hawn's? She looks like the aftermath of a couple of
rounds with Sugar Ray Leonard, which she clearly lost. How about Meg
Ryan? I don't know what she did, but she's not cute anymore. Joan
Rivers has always been the poster girl for plastic surgery, but
she's a caricature, not a real person. I flipped channels and caught
a glimpse recently of Priscilla Presley on "Dancing with the Stars."
After shaking my head and blinking a few times to be sure it wasn't
Marilyn Manson, I realized it was the formerly gorgeous wife of
Elvis Presley. Priscilla, what did you do to yourself?

When did the notion of beauty start to include nose number 72-S,
chin number B-14, and a round of blepharoplasty? What happened to
not smoking, getting exercise, eating healthy, staying out of the
sun, and making every attempt to enjoy life as a foundation for
beauty?

What's wrong with showing a little age? My crow's feet are from
years of squinting on sunny days and from laughing at good jokes.
The furrows in my brow make me look interested and curious. The
lines around my mouth make me look like my father. The bump in my
nose is directly from my maternal grandmother.

I know exactly who I am and I'm just fine.


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DENTAL AMALGAM


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Fillings become a burning issue for crematorium

Published: Thursday, 19th June, 2008 08:55

Dunferline Press

Dunfermline, Fife, UK

By Laura Cummings

THE COST of cremations in Fife could be set to spiral following a
hike in the number of Fifers with dodgy teeth being cremated.

An increase in the number of people being cremated in Fife who have
amalgam fillings in their teeth has led to an increase in mercury
emissions which are harmful to humans and even unborn babies.

In an attempt to curb the problem environmental protection
legislation has stated there must be a 50 per cent reduction in
mercury emissions from crematoria across the UK by 2012.

As a result £600,000 will be spent on Kirkcaldy Crematorium and
£600,000 on Dunfermline Crematorium to install special filtering
systems to meet the targets imposed.

Bereavement services manager for Fife Liz Murphy explained, "Mercury
is actually the amalgam in peoples' fillings that changes during the
cremation process and produces mercury. It goes up into the
atmosphere and goes around the world a couple of times before it
goes down into the ocean where it comes back into the food chain.

"The generations of people that are coming through the system now do
have a higher number of fillings in their teeth. Now dental practice
has improved and they're not using amalgam within fillings now. But
for this period of time for the next 20 years we have to be seen to
filter as much of it out as we can."

She continued, "There probably will be an impact on the cost of
cremations but we don't know as yet what that will be."

Initially mercury abatement equipment will be used to extract
mercury from the cremation process at Kirkcaldy Crematorium.

Special filters will be fitted to the existing equipment at the rear
of the crematorium.

Similar work at Dunfermline Crematorium will start after the work at
Kirkcaldy is complete.

Labour councillor for Dunfermline south, Mike Rumney, claimed Fife
Council's administration had decided to spend the required £600,000
per crematorium only in Kirkcaldy and spend nothing on Dunfermline
Crematorium.

But Lib Dem councillor for Dunfermline south, Tony Martin, said Mr
Rumney had misunderstood the decision taken at last Thursday's
policy, finance and asset management committee meeting, and that
£600,000 would also be spent from the next budget on installing the
equipment at Dunfermline Crematorium.

He explained, "We will be doing Dunfermline Crematorium but we can't
do both at the same time for obvious reasons. We will phase the
Dunfermline one after the Kirkcaldy one. We have had to delay it
because we have had to phase it.

"There's no danger to our staff or people living around there. We
have to comply with the legislation and we will do that. We would
meet the criteria if we just did one crematorium but it's still the
administration's intent to carry out work at Dunfermline Crematorium
at a later phase in order to reduce mercury emissions at
Dunfermline."

Mrs Murphy added, "Because we have two crematoriums (in Fife) we are
classed as a cremation authority so by putting equipment in at
Kirkcaldy that gives us the 50 per cent requirement.

"There are a higher number of cremations at Kirkcaldy compared to
Dunfermline. Initially it makes more sense to abate at Kirkcaldy to
reach the initial abatement requirements."

According to the National Association of Funeral Directors, mercury
is known to be toxic and can damage the brain, kidneys and nervous
system, while unborn babies are believed to be particularly
susceptible to its effects.

Work on installing the filter system at Kirkcaldy Crematorium will
start within the next year to 18 months.


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BIG PHARMA


---------------------------------------------------------------------
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Big Pharma Agrees To Stricter Ad Rules

Evening Bulletin

Philadelphia, PA,USA

By: Heather Chin, The Bulletin

06/23/2008

Washington - Top drug manufacturers including Johnson & Johnson,
Merck and Pfizer agreed last Monday to a six-month moratorium on
direct-to-consumer television advertising for new prescription drugs
and limitations on how doctors are used in their ads.

The agreements came amid increasing pressure from the Congressional
House Energy and Commerce Committee and the American Medical
Association (AMA) following earlier controversy surrounding
deceptive advertising for anti-cholesterol drugs such as Lipitor,
Procrit and Vytorin.

In signed letters, the executive directors of Johnson & Johnson,
(J&J), Merck & Co., Merck/Schering-Plough, and Pfizer agreed to take
steps towards implementing these recommendations.

Meanwhile, the Pharmaceutical Research and Manufacturers of America
(PhRMA) agreed to further meetings with the committee before
agreeing to any particular changes at the moment.

All of the companies agreed to adhere to the AMA's guidelines as to
the use of actors and health professionals. Specifically, they will
continue to identify instances in which an actor portrays a
physician, as well as whether the actor was compensated for their
appearance. Johnson & Johnson will discontinue use of doctors
entirely to discuss the benefits of a drug.

In the letters, each company also stated that the six-month
moratorium simply formalized their existing practice of educating
doctors before moving to consumer communications.

"We have adopted internal guiding practices on direct-to-consumer
advertising for prescription drugs [that] requires our operating
companies spend at least six months after approval of a new medicine
educating health professionals before commencing a direct-to-
consumer advertising campaign," wrote William C. Weldon, chairman-
CEO of J&J.

He added that since the advertisements are in line with FDA approved
labeling and measures of outcomes, they are an important tool to
provide information to patients and physicians, and "a particular
fixed period of time for an advertising moratorium is appropriate in
all circumstances."

Rep. John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairmen
of the committee's oversight and investigations panel, said they
were pleased with this response, but wanted the drug companies to
adopt the recommended two-year moratorium.

According to Mr. Stupak, he and Mr. Dingell called for the May 8
hearing of the House Energy and Commerce Committee, entitled "Direct
to Consumer Advertising: Marketing, Education or Deception?", to
both renew pressure and renew the struggle within Congress to
strengthen government regulation over such TV commercials. It was
also a step towards granting the Food and Drug Administration the
right to force changes in the ads before they air.

"Although we appreciate the drug companies' willingness to change
some of their business practices, they have not agreed to all of our
requests, which would protect consumers from misleading and
deceptive advertising," said Mr. Stupak.

Even with these agreements and the potential for future legislation,
the debate will go on. Part of that debate lies in the fact that
running these ads is mutually beneficial for both the pharmaceutical
companies and the TV industry.

Since 1997, when the government relaxed rules on TV and radio ads,
pharmaceutical companies shortened the warnings on side effects in
their commercials and spent about $14 million on broadcast and cable
TV ads for prescription drugs.

In 2007, drug makers spent over $5 billion on direct-to-consumer
ads, according to Nielsen Monitor-Plus; more than half of that on
television.

"The drug and TV and cable industries have formed a cabal here to
protect their revenues," said Gene Kimmelman of Consumers Union, an
advocacy group in favor of stricter limits on direct-to-consumer
drug marketing.

Ken Johnson, a PhRMA vice president, challenged that in a May
article in the Wall Street Journal. He insisted that consumer
advertising for prescription drugs "brings patients into their
doctors' offices and helps start important doctor-patient
conversations about conditions that might otherwise go undiagnosed
or untreated."

Still, many consider the ads to be intentionally misleading. "Direct-
to-consumer ads often portray drugs through rose-colored glasses by
including more information about a drug's benefits than risks," said
Dr. Nancy Nielsen, AMA President-elect, in testimony at the
congressional hearings.

"Imbalances in these ads can diminish patient understanding of
certain drug risks, and increase the need for an ongoing dialogue
between patients and physicians about the benefits and risks of
prescription drugs," Dr. Nielsen added.

Reporting contributed by AdAge.com and The Wall Street Journal.





Thank you for supporting Hadcorp.

http://implants.webs.com/

Thanks Sheila

June 26, 2008

Bills Would Restore Rights of Patients Injured By Faulty Medical
Devices

Legislation Would Overrule U.S. Supreme Court's  Anti-Consumer
Decision in Riegel v. Medtronic

WASHINGTON, D.C. – Public Citizen urged Congress to promptly pass
legislation introduced today that would restore the rights of
patients injured by defective or inadequately labeled medical
devices to seek compensation for their injuries from the device
manufacturers.

The Medical Device Safety Act of 2008 would overrule the U.S.
Supreme Court's February decision in Riegel v. Medtronic, which held
that the 1976 federal law that gives the Food and Drug
Administration (FDA) authority to regulate medical devices also
severely limits the right of injured patients to sue device
manufacturers. Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-
N.J.)   sponsored the bill (HR 6381) introduced in the U.S. House of
Representatives. Sens. Ted Kennedy (D-Mass) and Patrick Leahy (D-
Vt.) are expected to introduce a similar bill in the Senate.

The legislation would restore Congress' intent in enacting the 1976
law – that traditional state common-law remedies for injuries and
deaths caused by medical devices would work in tandem with federal
medical device regulation to protect consumers.

"The possibility of being held liable for injuries their products
cause creates an invaluable incentive for manufacturers to make
their products as safe as they can, to revise labels as soon as they
become aware that they are inadequate and to remove unsafe products
from the market," said Public Citizen lawyer Allison Zieve, who
argued on behalf of the Riegels in Riegel v. Medtronic. "By
eliminating this possibility, the Supreme Court decision removed a
significant layer of consumer protection, which makes passage of the
Medical Device Safety Act of 2008 so essential."

The Riegel case stemmed from a defective balloon catheter used
during an angioplasty procedure. When the balloon burst during the
operation, Charles Riegel was seriously injured. Riegel and his wife
sued Medtronic, the maker of the catheter, alleging that the company
had violated state-law duties not to market unreasonably dangerous
products and to provide adequate instructions and warnings of the
risks associated with the product.

Federal regulation plays a crucial role in protecting patients from
dangerous products, but, inevitably, some dangerous products will
reach the market and some patients will be harmed, Zieve said.
Certain Medtronic defibrillators, Guidant defibrillators, St. Jude's
Silzone-coated heart valve, and Sulzer's hip and knee prostheses are
recent examples of devices that have caused great injury. The
National Academy of Sciences' Institute of Medicine, the Government
Accountability Office and the FDA itself, among others, have
questioned the FDA's ability to protect the public.

"Given the FDA's failure to prevent numerous medical device
tragedies in recent years, the continued availability of common-law
remedies is essential," Public Citizen President Joan Claybrook said.

READ the House bill.

LEARN more about the Riegel case.

http://www.citizen.org/pressroom/release.cfm?ID=2682


I think what needs to be said is the truth it is a deliberate
inability to not protect the public due to manufacturer, Doctors
influence on this FDA and the tainted panels they have proves this.

If the money stopped flowing (payoff) and the Lobbyists were not
involved. And the politicians started doing what they were elected
to do this would not be going on as bad as it has been but until no
one can be paid off to look the other way and politicians were held
accountable this will continue.
Sandra

HADCORP NEWS: July 17, 2008

Depressed 10-Year-Olds Have Plastic Surgery in Mind

RedOrbit
Dallas, TX, USA
Posted on: Tuesday, 15 July 2008, 00:00 CDT

GIRLS as young as 10 are thinking about plastic surgery and dieting,
and feeling depressed if they don't own the latest mobile phones and
iPods.

The modern world has left many youngsters suffering stress, anxiety
and unhappiness because they aspire to the model looks of
celebrities, and feel they have to have top-of-the-range gadgets to
fit in with their school friends.

The findings, published in a study by Girlguilding UK today, paint a
depressing picture of a generation of confused young girls growing
up obsessed with looks and possessions, and becoming prematurely
interested in sex when they should be enjoying carefree childhoods.

Girls of all ages who took part in the study said the pressure to
grow up before they felt ready was among the greatest influences on
their mental wellbeing.

Feeling compelled to wear clothes that made them look older, sexual
advances from boys, and magazines and websites directly targeting
young girls with messages they should lose weight, wear make-up and
even consider plastic surgery were all identified as damaging.

One of the girls who filled in the questionnaire said: "When I was
11 I read a teenage magazine for the first time and that is when it
kind of clicked, 'I should be like this'."

One of the most disturbing findings was that self-harm is now
perceived as normal teenage behaviour for girls.

Pressure to own material goods like clothes, iPods and mobile phones
left one in five girls feeling angry or sad, according to the report
A Generation Under Stress?

Source: Yorkshire Post


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-----------


Plastic surgeon's perfect life marred

Doctor, who faced numerous disciplinary actions and tax evasion
conviction, charged with fraud in U. S.

National Post
Toronto, Ontario, Canada
Tom Blackwell, National Post
Published: Tuesday, July 15, 2008

His plastic-surgery training in hand, Lawrence Saks left the
Canadian winters he hated in the early 1980s and headed for what may
be the world's most welcoming market for such medical specialists:
esthetically obsessed southern California.

It was a profitable move. The product of a hardscrabble Quebec City
upbringing, Dr. Saks built a fortune in the millions of dollars and
forged a reputation as a generous philanthropist.

But that enviable life is suddenly on the brink of collapse. The 56-
year-old doctor has been charged with US$4-million in insurance
fraud and other crimes, allegedly for claiming handsome disability
benefits for himself while continuing to do tummy tucks, facelifts
and other surgery.

As it turns out, the fraud case is only the latest and most damning
in a string of brushes with the law and medical regulators.

Dr. Saks was earlier convicted of tax evasion, has twice had his
licence suspended for medical and other infractions and faces a
third potential rebuke by the California Medical Board related to
the death of a 29-year-old liposuction patient. Two years ago, the
Orange County superior court awarded another patient US$620,000 over
a liposuction incision that became horribly infected. A pair of
hospitals, meanwhile, yanked his admitting privileges for
disciplinary offences.

"I'm not a psychologist. I don't know why people who have everything
sometimes do stupid things," said Moshe Reiss, a cousin in Mont-
real. "I'm sure that you will find somebody who will say bad things
about even the best plastic surgeons. These guys work with people
who want to take imperfect and make it into perfect, and obviously
not everybody is happy with the results."

It was alleged economic crime, though, that led to Dr. Saks' arrest
last month. He was charged with mail fraud, wire fraud and money
laundering in an indictment that states he received about US$18,000
a month in disability payments under three insurance policies, based
on false claims that he was prevented from working by a neck injury.

In fact, the U. S. Attorney's Office alleges, he was still
performing operations the whole time, sometimes billing for those
procedures under another doctor's name, and depositing the money
under an identity stolen from a Filipino-American who died in 1990.

When an insurance investigator posed as a patient and visited his
practice in Torrance, Calif., a suburb of Los Angeles, Dr. Saks told
the undercover operative he was tired because "I sucked out a lot of
fat today," according to an FBI affidavit.

Jason Gonzalez, the assistant U. S. attorney handling the
prosecution, said he was unable to comment on the case. Dr. Saks'
lawyer, Richard Steingard, could not be reached.

But in a document filed in court, the defence attorney refutes the
federal government's allegations, saying that Dr. Saks' insurance
claims were justified under his policies, and endorsed by a
respected disability-insurance attorney. The social insurance number
he used for some of his deposits was not stolen from a dead person:
It was his old Canadian S. I. N., the document said.

But the new case is among numerous stumbles -- and some more noble
episodes -- on the physician's colourful journey from Quebec City to
L. A.'s Metropolitan Detention Centre.

His parents were survivors of the Holocaust, his father considered
a "hero" for helping fellow inmates of a concentration camp, said
Mr. Reiss, the cousin. Like many survivors, though, they immigrated
to Canada with much emotional baggage and little financial
means. "He grew up in a very, very difficult environment," the
relative said.

He said Dr. Saks was a highly motivated medical student at McGill,
where he later also did a residency in plastic surgery, after his
initial brief sojourn in the United States.

In California, the home of Cher, Pamela Anderson and other icons of
surgical enhancement, Dr. Saks lived the American dream. The
Canadian owns several properties, including an apartment building
with more than US$3.2-million in equity, and a bank account
with "millions" in cash, according to court documents and hearing
transcripts.

As far back as 1990, though, Dr. Saks was convicted of evading taxes
on $660,000 in patient fees and sentenced to six months in a prison
camp and halfway house, while the medical board put him on probation
for five years.

Then in 2003, the board suspended him for four months and ordered
another seven years of probation, partly because of his treatment of
a 70-year-old patient with heart disease, who died about two weeks
after he performed liposuction and other procedures on her. Dr. Saks
admitted to improperly assessing the high-risk patient before
embarking on the surgery, and failing to adequately monitor her
after the operation.

In late 2005, a judge awarded US$620,000 to Pattiann Garcia and her
husband, finding that the surgeon had for two months played down a
surgical infection in the liposuction patient. It spread to her
heart and led to a lengthy hospital stay, massive scarring
and "excruciating" pain when she finally had a series of operations
to clear out the bacteria.

The most serious accusations against Dr. Saks, however, come in a
2006 California Medical Board disciplinary case that focuses on a 29-
year-old female patient. Half an hour into a liposuction operation
at his out-patient clinic, the young woman started going into
cardiac arrest and later died in hospital.

An adjudicator concluded Dr. Saks had breached medical standards in
various ways, including by performing some of the liposuction
himself, instead of focusing on his assigned duty that day as
anaesthetist. The adjudicator recommended an eight-month suspension,
but Dr. Saks' punishment is under review.

At the same time, Dr. Saks has given generously to local synagogues,
paying for buildings in honour of his parents, and donating $1-
million to a Jewish education centre, according to a court document
his lawyer filed.

He came to Canada repeatedly to look after his parents before their
deaths, and provided considerable support to his mentally challenged
brother, according to his cousin.

"As far as I am concerned, he was always a good guy and always had a
good heart on him," said Mr. Reiss. "Obviously ... he got
sidetracked over certain issues over the years."


---------------------------------------------------------------------
-----------


MEDICAL DEVICE NEWS


---------------------------------------------------------------------
-----------


Workers who blew the whistle on their employers split millions

Buffalo News
NY, United States
By Dan Herbeck
Updated: 07/06/08 8:28 AM

It all started with an honest citizen finding out about a scam and
making a phone call.

When Craig Patrick raised questions about some of the sales
practices at Kyphon Inc., the medical device company where he
worked, some of his co-workers called him a complainer and a
squealer.

Patrick is now a multimillionaire, and the insults don't bother him
so much anymore.

His concerns about the company led to a "whistle-blower" lawsuit in
Buffalo's federal court. The suit, which accused Kyphon of inflating
the cost of spinal procedures in Buffalo and throughout the nation,
was recently settled when the corporate successor to Kyphon agreed
to pay $75 million.

As part of that settlement, Patrick and Chuck Bates, another former
Kyphon executive, are splitting more than $15 million that was
awarded to them in the case.

The whistle-blower lawsuit is a little-publicized, little-understood
procedure that allows citizens to sue businesses that cheat the
federal government. In recent years, companies have paid billions of
dollars to settle such lawsuits, and many whistle-blowers have
received millions.

In another Buffalo whistle-blower case, National Air Cargo of
Orchard Park paid $28 million to settle allegations that it
overcharged the U. S. military for air deliveries. In that case, a
former NAC employee, Mark Oehm of Cheektowaga, received $3.3 million
for alerting the feds.

Oehm was guided through the complicated lawsuit process by two
Buffalo attorneys, Daniel C. Oliverio, a former federal prosecutor,
and Joseph V. Sedita.

"It's a win-win situation when one of these cases is successful,"
said U. S. Attorney Terrance P. Flynn. "The whistle-blower receives
some money, the taxpayer benefits because the company reimburses the
government for millions of dollars, and we are able to bring an end
to a pattern of fraud."

According to Mary Louise Cohen, a Washington, D. C., attorney who
represented Patrick in his case, federal prosecutors in Buffalo have
built up a national reputation for their willingness to pursue such
cases. While Patrick and Bates work in California, the company does
business in Buffalo.

But Cohen warns that anyone who expects to make easy money by filing
a whistle-blower case should think again. Only about 25 percent of
cases filed wind up being successful.

"If you're going to file a case, steel yourself for a three-or four-
year ride that can be very uncomfortable at times," Cohen
said. "After they file a complaint, some people get fired. I've had
clients who had to go onto food stamps while their case was working
its way through the system."

Patrick said that his experience wasn't easy, either.

"It's a very stressful process, from beginning to end," said the 43-
year-old, now living in Hudson, Wis. "While the lawsuit is pending,
you're not supposed to tell anyone about it. You're wondering if
your work friends will ever speak to you again, and some won't."

Patrick said he brought his suspicions to his bosses before he ever
considered filing a lawsuit.

"Over a period of months, I reported that fraudulent things were
going on," Patrick said. "I was told by [a company official], `It's
not your job to police the sales staff.' "

In Patrick's case, he and federal prosecutors from Buffalo accused
Kyphon executives of vastly inflating the profits for selling
medical equipment for a spinal procedure called kyphoplasty.

Cohen said the procedure can be done in about an hour on an
outpatient basis, but Kyphon officials persuaded doctors and
hospitals — in Buffalo and other cities — to keep patients
overnight.

That allowed medical providers to charge the Medicare system up to
$10,000 per procedure.

In May, officials of the corporate successor to Kyphon — Medtronic
Spine LLC of Fridley, Minn. — agreed to pay the federal government
$75 million to settle the case. But Medtronic officials did not
admit to defrauding the government.

"I think the admission is inherent in the fact that they're paying,"
Patrick said.

Flynn said he believes the lawsuit put a stop to fraudulent activity
and will save taxpayers millions of dollars annually.


---------------------------------------------------------------------
-----------


BIG PHARMA


---------------------------------------------------------------------
-----------


The unhealthy ties that bind FDA to drug firms

Boston Globe
United States
By Chuck Leddy
July 5, 2008
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling
Antidepressant on Trial

By Alison Bass
Algonquin Books of Chapel Hill,260 pp., $24.95

In her new book Alison Bass obeys the most important rule of
investigative journalism: She follows the money wherever it leads.

In "Side Effects," her examination of mammoth pharmaceutical
companies and their pursuit of profits at any cost, she exposes the
dark web of researchers, doctors, and regulators feeding at the Big
Pharma trough and undermining public health in the process. The term
for what Bass discovers is "systematic funding bias." As she makes
abundantly clear, medical professionals taking money from Big Pharma
tend to give Big Pharma what it wants.

The Food and Drug Administration is supposed to be looking out for
public health and consumer safety by objectively reviewing drug
trials submitted by pharmaceutical companies seeking approval for
new drugs. But who pays the FDA for this important watchdog
function? Big Pharma does. As Bass, a onetime Globe reporter,
writes, "The industry's allocation of $232 million in user fees
represented 53 percent of the agency's entire drug review budget" in
2004. Does this funding system, which continues to this day, create
the potential for the FDA to become indebted to the very industry
it's supposedly regulating?

If Bass's investigation into the antidepressant Paxil, a
multibillion-dollar cash cow for GlaxoSmithKline, is any indication,
the FDA's public-watchdog function seems to need more teeth. She
shows that Glaxo's research studies found that Paxil "failed to
demonstrate any separation" between itself and a placebo (a sugar
pill) in adolescents.

Moreover, she contends Glaxo and its researchers either ignored or
suppressed evidence that the pediatric use of Paxil could lead to
thoughts of suicide. Glaxo "made no reference to the negative
results" from these trials, instead recommending Paxil for pediatric
use. Bass illustrates how Glaxo paid huge amounts of money to
conduct these research trials, and how medical researchers in the
pay of Glaxo worked to give the firm the positive study results it
wanted.

Bass looks at a Paxil study conducted by a medical researcher whose
employee, Donna Howard, came to believe that he "was playing fast
and loose with the protocols for the Paxil study" and was
suppressing evidence of suicidal thinking in patients by "not
accurately coding these adverse events." Eventually she contacted
the author. Bass finds that the researcher was receiving hundreds of
thousands of dollars annually from Big Pharma.

With evidence of Paxil's problems mounting, the FDA belatedly
required that a warning label be placed on the drug. Meanwhile, it
took the New York attorney general's office to compel Glaxo to
publicly disclose Paxil's link to suicidal thoughts. Bass provides a
dramatic account of this lawsuit, following state attorney Rose
Firestein as she digs up evidence of Glaxo's deceptive conduct.
Firestein pursues a consumer-fraud case against Glaxo, arguing
that "the negative study results on Paxil were material to a
doctor's judgment in treating patients, and they had been
concealed."

Glaxo eventually made a cash settlement and disclosed the negative
studies. More important, notes Bass, the case "shone a spotlight
into the black hole of drug research" and triggered "a growing
outcry about the enormous influence the pharmaceutical industry
wields over the practice of medicine." As Bass demonstrates, the
free market is a powerful, creative force, but some things should
never be put up for sale. Public health is one of them, and with the
help of investigative journalism like "Side Effects," maybe "Money
talks" will give way to the needs of public health. Stranger things
have happened.

Chuck Leddy is a freelance writer who lives in Dorchester.



http://implants.webs.com/

WASHINGTON (AFP) - The United States lags behind other
industrialized nations in the quality of its healthcare despite
having the costliest system in the world, according to a report
released on Thursday.




The US healthcare system is plagued by inefficiency, inequality and
an incoherent national policy, said the report from the private
Commonwealth Fund foundation.

"The US spends twice per capita what other major industrialized
countries spend on health care, and costs continue to rise faster
than income," said the report.

"We should expect a better return on this investment."

The foundation used a 100-point scorecard to rate the system based
on 37 categories, including access to health care, quality of care
and efficiency.

The US average came to 65, two points down from a previous measure
in 2006. The score is compared to other countries and the best
performing US states, counties or hospitals.

The measures showed "that the US is losing ground in providing
access to care and has uneven health care quality" and also
revealed "broad evidence of inefficient and inequitable care," it
said.

The United States ranked last among 19 industrialized states when it
comes to preventing premature deaths from conditions such as heart
attacks that can be treated with timely, effective care, the report
said.

Up to 101,000 less people would die prematurely if the US achieved
the lower mortality rates of top performing countries such as France
or Japan, it said.

Infant mortality rates also remain high in the United States
compared to other industrialized nations.

Access to health care was on the decline, with more Americans
without health insurance or without adequate insurance. In 2007, 75
million working-age adults were either uninsured or underinsured, up
from 61 million in 2003.

Americans reported more delays in securing appointments with
doctors. "In 2007, as in 2005, less than half of US adults with
health problems were able to get a rapid appointment with a
physician when they were sick," it said.

The US scored poorly on efficiency, with patients subjected to
duplicate tests, unnecessary hospital admissions, high
administrative costs and outdated record keeping, it said.

Only 28 percent of US doctors use electronic medical records,
compared to nearly 100 percent in leading countries.

The report, based on data from US government agencies and other
sources, underlined some areas of progress, including improved
safety at hospitals and better control of diabetes and high blood
pressure.

HADCORP NEWS: July 20, 2008

Leading Story

Top TV surgeon pays six-figure damages to woman who had a stroke
during facelift

Daily Mail
UK
By Chris Brooke
Last updated at 7:52 AM on 18th July 2008

A plastic surgeon has agreed a six-figure compensation payout to a
woman who suffered a stroke during a facelift operation.

Diane Newbould, 53, sued Jan Stanek for negligence after she was
left severely disabled, unable to speak properly and in need of
lifetime care.

Mr Stanek, well-known through his role on a reality TV series, is
also being sued by BBC newsreader Kate Silverton after laser
treatment forced her to stay off work with an allegedly bloated
face.

Mrs Newbould will never recover from the facelift and liposculpture
operation at a private London hospital in January 2002.

Mr Stanek was accused of failing to take properly into account her
medical history and health by going ahead with the surgery.

Yesterday Mrs Newbould's counsel, Simeon Maskrey QC, told London's
High Court that Mr Stanek and the anaesthetist, who was also being
sued, had agreed to a substantial settlement.

Although the payout amount was kept confidential, her solicitor,
Janet Baker, revealed outside court it is 'a significant, six-figure
sum'. The settlement was agreed without any admission of liability.

Based in Wimpole Street, London, Mr Stanek is considered to be a
leading surgeon and has a high public profile after appearing in the
Five series Plastic Fantastic, and the Channel 4 programme 10 Years
Younger.

In documents before the court, Mrs Newbould's lawyers alleged not
enough account was taken of her 'poor medical history'.
She was obese, a heavy smoker and her medical problems included
bronchitis and hypertension.

They claimed she should have been told to 'undergo significant
lifestyle changes' - particularly to lose weight and cut down on
cigarettes - before surgery.


Mr Maskrey told the court that Mrs Newbould, formerly from
Sheffield, was cared for after surgery by her husband, until that
became impossible when he suffered two strokes.

The couple recently moved to southern Spain, where Mrs Newbould is
cared for by her daughter and son-in-law.

Mr Justice Cranston approved the settlement after a brief hearing
today. The family was not in court.

Miss Baker said after the hearing that the family were 'very happy'
that the matter had been settled and the payout would be used to
cover the costs of future care.

In January Miss Silverton reportedly instructed lawyers to begin
legal action after she had treatment at Mr Stanek's clinic.

She said: 'I was told it would be a routine procedure and I'd be
back to work in days.

'The treatment, however, caused a massive skin reaction.'
Mr Stanek, an Oxford-educated fellow of the Royal College of
Surgeons, is a frequent lecturer on 'aesthetic surgery' and has
published journal articles and books.

His practice's website refers to operations on more than 10,000
patients in the past 20 years and treatments offered include tummy
tucks and breast and cheek implants.


---------------------------------------------------------------------
-----------


Cosmetic doc fired for `impairment'

Two other Beth Israel allegations date to '01

Boston Herald
United States
By Jessica Fargen
Sunday, July 20, 2008

Beth Israel Deaconess Medical Center has fired a high-profile
plastic surgeon - who once criticized third-rate cosmetic doctors
during a "Dateline NBC" expose - after an "impairment" issue during
a surgery he conducted last month.

Dr. Loren J. Borud, 44, was fired effective Friday, the hospital
said in a statement. The firing came two days after the Herald began
inquiries into two previous allegations of impairment involving
Borud that date to 2001. Two medical sources said Borud had been
disciplined internally by the hospital twice in the past seven
years.

The Board of Registration in Medicine, which investigates complaints
against Massachusetts doctors, has been notified, the hospital said.

Borud was suspended June 30 following a June 27 incident at the
hospital, said Kenneth Sands, the facility's senior vice president
of health care quality. He would not say when the decision was made
to fire Borud.

He also would not specify the nature of Borud's "impairment."

"This is a timely action related to timely events," Sands said.

The Borud incident occurred three days before an unrelated wrong-
site surgery was performed at the Harvard-affiliated hospital,
prompting a state investigation.

Borud runs Loren J. Borud Plastic Surgery, which operates out of
Beth Israel and offers Botox, breast implants, liposuction and other
cosmetic procedures.

According to his business Web site, Borud is certified by the
American Board of Plastic Surgery and is a full-time faculty member
at Harvard Medical School, teaching in the Plastic Surgery Residency
Program.
"We pride ourselves on providing the individual care and attention
of a private practice setting with the impeccable safety standards
and resources of a top-tier Harvard hospital," the site says of
Borud, who appeared in a 2005 "Dateline NBC" report on third-rate
cosmetic surgery abroad.

Telephone and e-mail messages left for Borud on Friday and yesterday
were not returned. He did not answer the door at the home in Newton
listed as his address.

Borud is on medical leave "at the moment," according to an automatic
e-mail reply generated from Borud's hospital account yesterday. His
attorney, Bruce Singal, declined to comment.

In an interview Thursday, Sands declined to comment on Borud's work
history. Asked if the hospital knew of alleged impairment issues
prior to June 27, Sands replied:

"We followed all required and recommended processes, making use of
the Physician Health Services in Massachusetts," a program of the
Massachusetts Medical Society. "That is considered the best option
in these cases."

Physician Health Services is a nonprofit corporation that provides
confidential consultation and support to physicians, residents and
medical students facing health concerns related to alcoholism,
substance abuse and behavioral or mental-health issues.

Borud's "physician profile" on the Web site for the Board of
Registration in Medicine lists no record of reportable hospital
disciplinary action in the past 10 years.

By law, hospitals are required to notify the Board of Registration
of suspension of privileges imposed on a physician, said Russell
Aims, a spokesman for the board.

Dr. Sidney Wolfe, who directs the Health Research Group at Public
Citizen, the consumer safety group founded by Ralph Nader, said
what's made known to the public about physician behavior can
sometimes differ from reality.

"Why should a patient not know that a physician in whose hands they
are placing themselves has a substance-abuse problem, particularly
when they are allowed to continue operating?" he said, speaking
generally and not about this particular case.

"Wouldn't you as a patient like to know whether this doctor has a
substance-abuse problem? There is a strong argument from a patient
perspective that once someone has problems serious enough to go into
a treatment program and they are practicing medicine it should be
made public," Wolfe said.


---------------------------------------------------------------------
-----------


Cowboy clinics 'will scar thousands'

Plans to end inspections of cosmetic surgeries is likely to lead to
many more patients being burnt or seriously scarred, admits
government report

guardian.co.uk
UK
Denis Campbell and Rowan Walker
The Observer, Sunday July 20, 2008

Thousands of people undergoing laser treatment could be left with
burns and scars as a result of government plans to end inspections
of clinics, the Department of Health has admitted.

Up to 3,400 more patients could be harmed by cosmetic procedures to
remove a mole, tattoo or unwanted hair, according to a consultation
paper on the move drawn up by Whitehall officials themselves. The
change, which critics claim will allow cowboy operators to open
premises that have poor safety standards because they would no
longer need to apply for a licence, comes into effect on 1 October.

A two-page appendix to the paper, headed 'Deregulation of lasers and
lights - possible effect on the number of adverse incidents', said
that harmful outcomes may double. It reads: 'Laser and light
treatments ... are potentially harmful and they will generate
adverse incidents ... Deregulation would generate an extra 1,700-
3,400 adverse incidents per year.' There are already an estimated
3,400 each year.

'It's shocking that the government is prepared to countenance
thousands more people being injured as a result of this
deregulation - and it's an astonishing thing to admit,' said David
Gault, a consultant plastic surgeon who specialises in laser
treatments. 'While some of these "adverse incidents" involve only
minor scarring or pigmentation, people's sight can also be damaged
by a powerful laser being shone into their eyes. The psychological
harm from these things happening is, in my view, harsher than the
physical damage people suffer,' added Gault, the British Association
of Aesthetic Plastic Surgeons' spokesman on the issue.

Skin laser treatments are a booming area of the cosmetic surgery
industry, with an estimated 340,000 performed in England alone
annually. They are also used to remove wrinkles, freckles and
unsightly 'spider veins'. Previously only found in specialist
hospitals, laser machines are increasingly used in beauty salons and
hairdressers. Ministers have been criticised for scrapping the
existing system whereby the Healthcare Commission, the NHS watchdog
for England, inspects and monitors the safety of the 900-plus laser
clinics.

Critics have argued that the change, designed to lighten the
commission's workload, will end up costing more money than is saved.

The paper said: 'Based on the estimate of increasing the number of
adverse incidents by between 1,700 and 3,400 cases, this represents
a yearly extra cost of treating these cases of between £900,000 and
£1.8m.' The costs, it added, were likely to fall on the NHS.

That compares with £1.4m a year spent by the watchdog conducting
initial inspections of laser surgery premises when they first
register, monitoring annual self-assessment forms submitted by
clinics and carrying out a further safety visit to all 922 licensed
premises every five years.

Health campaigner Jenny Driscoll of the consumer organisation
Which?, which has exposed malpractice in the cosmetic surgery
industry, said: 'It's shameful and absolutely inexplicable that the
government is introducing a policy that it admits will ultimately
lead to more people being harmed. It's shocking that it could do
this, especially when so many people have said "don't do this
because more people will be harmed if you do".'

Even the Independent Healthcare Advisory Services, which represents
cosmetic surgery operators, is opposed. 'The government's proposal
means that anyone could purchase low-cost, low-quality non-approved
equipment and operate it anywhere without any training or safety
considerations on vulnerable adults as well as children,' said
spokesman Paul Stapleton.

In a letter last week to Which? the health minister Ben Bradshaw
defended the plan as 'the right way to proceed'.

A department spokeswoman said the planned deregulation of laser
treatment clinics was part of wider moves to 'ensure regulation [of
independent healthcare facilities] remains proportionate to the
risks'.

'I felt burning ... it looked like a disease'

Danielle Brown, a 31-year-old PA, tells of the after-effects of
laser treatment.

'A friend of mine had her hair removed by laser at a clinic on the
south coast and she looked amazing, I wanted the same. On arrival at
the clinic, they gave me a patch test. I was supposed to wait 24
hours, but within an hour I was receiving treatment, which lasted
five hours.
'I had a bit of tingling, but the laser was only set at a low
frequency.

The second time I went I felt burning almost straight away. The
power on the laser had been increased and I got badly burnt on my
arms, under arms, bikini line, on the back of my legs. I was told it
was normal and I would need eight sessions. The next day the burns
started to blister up , my skin was popping. I rang the clinic to
explain but they weren't interested. I looked like I had a disease
and everybody asked me what had happened.

'It wasn't until I went to another clinic two years later, that I
realised the machine that they had used on my Sudanese skin was
meant for white skin only. I think I will be scarred for life.'


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-----------


Dying patient left alone for 30 minutes

Court documents detail death of realtor; college had concerns about
risks at cosmetic clinic

Hamilton Spectator
Hamilton,ON,Canada
July 19, 2008
ROBERT CRIBB
TORSTAR NEWS SERVICES
TANYA TALAGA

The young real-estate agent who died last year after a liposuction
procedure at a Toronto doctor's office was lying in a recovery room
for 30 minutes with no vital signs before anyone called 911,
according to allegations filed in court.

Documents detailing the death of realtor Krista Stryland also show
that the College of Physicians and Surgeons of Ontario had concerns
about risks to patients being treated at Dr. Behnaz Yazdanfar's busy
cosmetic clinic as far back as 2002.

And just over two months before Stryland's death, another patient
had serious complications after five litres of fat were
liposuctioned from three body parts in a single session, according
to court documents. The college alleges that Yazdanfar previously
told the college that she only removes under two litres of fat at a
time, and only performs liposuction on one body area per procedure.
That patient survived and her family has complained to the college
as well.

Stryland, 32, died on Sept. 20, 2007. The young mother had gone to
the Toronto Cosmetic Clinic for liposuction. Both the hospital
doctor who later tried to revive her and the coroner suggest the
delay could have contributed to her death.

The college is seeking a court order to compel Yazdanfar's co-
operation in its investigation of her medical practice. The court
hearing is Tuesday. In support of the application, the college has
filed hundreds of pages of documents. Some remain subject to a
publication ban or have portions blacked out. This story is based on
documents in the public domain.

Yazdanfar is not accredited as a plastic surgeon and holds no
surgical designation. A Star investigation last fall documented the
college's dithering around regulation of the rapidly expanding field
of cosmetic surgery.

Today, hundreds of MDs without recognized surgical training continue
to perform cosmetic procedures in private offices over which the
college has limited oversight.

The court documents reveal a lengthy history of college involvement
in Yazdanfar's practice.

Tracey Tremayne-Lloyd, a Toronto lawyer representing Yazdanfar, said
each of the issues raised by the college over the past six years
was "addressed and rectified."

"(Stryland) suffered her unfortunate complication in the recovery
room. The surgery went perfectly fine. It was in recovery that
something happened to the patient. The patient took a very sudden
downturn that had to be dealt with as an emergency," Tremayne-Lloyd
said.

Back in 2002, the college looked into a complaint about her lack of
formal training. Yazdanfar told investigators she had taken "a
course in liposuction in Colorado the previous spring and had been
performing the procedure since then," court records show. Because
the college had no specific standards for cosmetic surgery, the
investigator concluded the doctor's training was "adequate but not
extensive."

The next year, a college-appointed plastic surgeon was asked to
assess Yazdanfar's practice. He concluded she had the "skill,
knowledge and judgment to safely practice liposuction," but found
several areas where her practice fell "below an acceptable standard
of care."

For example, the assessment report said Yazdanfar's assistant, an
Iranian nurse, "is not actually a registered nurse in Ontario and
has not taken the College of Nurses Licensing exams." The report
called Yazdanfar's practice of delegating duties such as infusions
(giving fluids by intravenous) to the nurse "an unacceptable
standard of practice."

Documents filed in court by Yazdanfar indicate those problems were
subsequently remedied.

Other documents in the file raise alarm bells about patient safety
in the years leading up to Stryland's death.

A college letter to Yazdanfar in April, 2004, stated the college
was "quite troubled by the lengthy list of deficiencies at your
facility, relating to sterilization and infection control practices,
lack of appropriate equipment and room allocation."

A follow-up assessment last year found the cleanliness issues had
been dealt with.

Throughout the documents, the college raises issues common to its
general concern about unregulated surgeries.

For example, in 2006, a college-appointed assessor raised concerns
about the use of anesthesia in a private clinic where the
normal "protective envelope" of a hospital is missing.

"Dr. Yazdanfar does not have hospital privileges," the assessment
report says. "She should therefore have at the very least, a
standing relationship with the surgical department of a hospital
that would guarantee the efficient, speedy and safe transportation
of her patient to that hospital for ongoing surgical care in the
event that it would be necessary. Instead, Dr. Yazdanfar would refer
her patients to the Emergency department and depend on the medical
personnel in that department to make appropriate decisions about the
management of her surgical patients. When surgical complications
arise requiring transfer and admission the process should be as
seamless and efficient as possible."

Two months before Stryland's death, a 66-year-old patient had
complications after liposuction surgery performed by Yazdanfar, the
court records allege.

In a complaint to the college filed by Francine Mendelson's
daughter, she alleges her mother's "fluid loss was staggering, and
the fact that she was sent home in that condition was truly
unbelievable," states the complaint by daughter Dr. Stacey
Mendelson, a veterinarian.

The Mendelsons allege that when Francine visited her family doctor
12 days later, he immediately sent her to emergency at North York
General Hospital where staff performed an ECG that indicated serious
cardiac abnormalities. She was admitted and spent five days under
the care of a cardiologist. The college records allege that five
litres (5,050 ml) of fat was taken from the woman's abdomen, lower
back and upper back in a single session. The college alleges that
Yazdanfar previously told college officials she only operates on one
body area per session, and only removes one to two litres of fat at
a time.

Yazdanfar lawyer Tremayne-Lloyd said the Mendelson complaint has
been answered in full, including an expert report that
indicates "the woman was treated entirely appropriately," and said
Yazdanfar "has never breached her undertakings to the college and
would never do so."

Two months after Mendelson's procedure, Krista Stryland went to the
clinic for liposuction surgery. Following the birth of her only
child, she wanted to lose weight. When problems emerged during her
operation "the patient deteriorated in the recovery room and there
was allegedly some delay in calling 911," according to a memo from a
college investigator.

Based on information supplied by a doctor who attempted to
resuscitate Stryland, the investigator said the doctor's
understanding was that "Mrs. Stryland's vital signs were absent for
30 minutes and then an ambulance was called and Mrs. Stryland was
transferred to North York General Hospital. Resuscitation efforts
were ongoing for two hours."

The college investigator notes that neither Yazdanfar nor the
anaesthetist accompanied Stryland in the ambulance. A nurse from the
clinic did come but she was "not present during the case," the
investigator's memo said.

In answer to the alleged 30 minute delay in calling 911, Tremayne-
Lloyd said both her client and the anaesthetist were still at the
clinic after Stryland was moved into the recovery room and "it's my
understanding that (the anaesthetist) checked his patient ... I
think it's highly improbable that that state of facts will be proven
to be true." According to her lawyer, Yazdanfar was in the middle of
another surgery, so she sent her most senior registered nurse with
Stryland, who had complete knowledge of Stryland's case. "They did
the best they could. There is no requirement in law that a physician
accompany their patient to hospital."

At the hospital, Stryland was in cardiac arrest. Doctors tried to
resuscitate her, and called in Dr. Sean Rice, a certified plastic
surgeon.

Rice, in a letter to the college, describes how he called Yazdanfar
at her clinic to find out what happened. Yazdanfar "stated that she
was a cosmetic surgeon and had performed the operation numerous
times in the past." Rice asked her if there was "the potential for a
possible puncture to an internal organ" but Yazdanfar said this was
not possible. "Dr. Yazdanfar then asked how the patient was doing, I
stated it appeared that Mrs. Stryland was not going to survive,"
Rice's letter to the college says.

Another memo from a college investigator says coroner Dr. James
Edwards also raised a concern about a delay in calling 911.

The college's "broad investigation" into Yazdanfar intends to
determine whether she has committed "an act of professional
misconduct or is incompetent," court records show.

College investigators have asked to observe her performing surgery
and interview her about her "knowledge, skill and judgment in
cosmetic surgery" and ask questions about "specific cases under
review." The college has also requested documents from Yazdanfar
including her surgical schedule and information related to two
patient testimonials on her website.

Yazdanfar has declined all such requests. Her nursing staff has also
declined requests from the college to be interviewed.

When the college issued the summons requiring her to meet with them
and produce documents, she also refused, arguing that she is not
legally obligated to co-operate with the investigation.

Tremayne-Lloyd said that while Yazdanfar has provided the college
with numerous charts, appointment books and other records, she will
not submit to an interview or allow a college assessor to watch her
practise surgery.

"It is our position that the college wish to go way beyond their
legal jurisdiction and way beyond what would be considered legally
appropriate. They want to force her to allow a college inspector to
stand and watch her and that expert will then become the college
expert in a prosecution against her ... The whole thing strains
credulity that she should be forced to do that."



http://implants.webs.com/

I just completed transcribing the Reid v Dow Corning deposition
transcript of Robert Rylee of Dow Corning. This is a list of the
documents that were placed under protective orders. As long as these
documents are buried in the judicial system, the public will never
hear "the rest of the story".

Pam Dowd
Implant Veterans of Toxic Exposure


DOW'S HIDDEN DOCUMENTS
Verdict in Stern v Dow case, final settlement agreement, terms and
amounts were placed under protective order
Suggested Surgical Procedures brochure—1979 publication
Article by Gordon Robertson and Silas Braley—1973
Two-year dog study
Digest of complaints
Customer Complait file listing
Letter—October 7, 1984 from Dow Corning U.S.A. in Hemlock to Lois
Deul
regarding Dr. Vinnik's involvement in writing package insert
Memo—January 8, 1985- J. Cooper concerning biosafety testing
concerns/
memo appears to indicate that as of the date of writing in January
of
'85 Dow Corning did not have any lifetime carcinogenicity study also
refers to biosafety testing
Memo—Mar  7, 1985- Mr. Boley is referring to the lack of a valid
carcinogenicity study to date in March of '85
Facts you should know booklets—1976 and 1980
Reid v Dow—Robert Rylee Deposition pages 123-134 are not recorded
and
are marked as confidential
Patent and cover
Dow Corning position statement—Numbers of formulas


OTHER INFORMATION UNDER PROTECTIVE ORDER
Dow Corning's market share of the business versus other
manufacturers
was in 1979
Total number of breast implants sold by Dow Corning in 1979
Interrogatory No. 60 regarding health risks associated with Dow
Corning gel filled breast implants
Complaint procedures prior to 1980—location, numbers, handling
Criteria for pass—fail of testing silicone implants
Albino rat study—1976

HADCORP NEWS: July 21, 2008

Leading Story

Fluoride Still in the News: Risks Noted for Kidney Patients,
Children, Seniors

By Lee Michaelson and Gail McDonald-Tune
Topanga Messenger
Topanga,CA,USA

The National Kidney Foundation (NKF) recently withdrew its
longstanding support for fluoridation of public water supplies.
Although scientists have long raised concerns about the risks of
fluoridation to public health, especially in susceptible
populations, including infants, seniors and those suffering from
chronic renal diseases, the NKF had allied itself since at least
1981 with the American Dental Association (ADA), which listed the
NKF on its website as an organization that "recognize[s] the Public
Health Benefits of Community Water Fluoridation for Preventing
Dental Decay." In a position paper issued in 1981, and relying on
scientific data from the 1970s, the NFK also stated there
was "insufficient evidence at this time" to recommend the use of
fluoride-free water for those with kidney disease.

In a new position paper, dated April 15, 2008, the NKF reversed its
previous stance, and the foundation's name has since been removed
the list of fluoridation-endorsing organizations on the ADA website.
However, the NKF issued no press release and its new position paper
did not come to media attention until early June.

According to the new paper, the NKF was moved to reexamine its
stance on fluoridation by a number of factors, among them a
challenge by an attorney who intimated suit might be filed on behalf
of renal patients who had relied on what he characterized as the
foundation's "outmoded" advice that fluoridation was safe. But
perhaps most compelling were the March 2006 report of the National
Research Council (NRC) on fluoridation and a recently published
review by Kidney Health Australia, strongly suggesting that NKF's
position on fluoridation was obsolete.

The NKF's new position paper emphasizes the NRC's finding that "a
potentially susceptible subpopulation comprises individuals with
renal impairments who retain more fluoride than healthy people do."
The NKF paper also takes note of the multiple vehicles, including
foods, beverages, drugs, toothpastes (which contain 1,000-fold more
fluoride than drinking water), as well as fluoridated drinking
water, through which fluoride is ingested; the fact that many of
these products are not labeled for fluoride content, making it
impossible to monitor the fluoride dosage actually being received by
renal patients and others; and the scientific research documenting
the health risks of fluoride, among them, dental and skeletal
fluorosis, weakening of the bones, and an increased rate of
fractures. The NKF observes that the worst of these risks appears to
be associated with intake of fluoride at levels as much as four
times higher than those commonly used in the fluoridation of public
drinking water. However, the NKF report notes that those in the
advanced stages of chronic kidney disease (CKD)–stages 4, 5 and 5D–
"retain more fluoride than healthy individuals,"; in fact, their "[f]
luoride blood levels are approximately 4-fold higher" than those of
the general populace. "

It has long been acknowledged that fluoridated water cannot be used
in dialysis, which sustains the lives of patients in renal failure.

However, the NKF paper reports instances of severe illnesses and
even several deaths following water system and hospital equipment
accidents which allowed the introduction of fluoridated water into
the dialysis process–including one in Annapolis in 1979 in
which "approximately 1,000 gallons of 22 percent hydrofluorosilic
were accidentally added to the ... public water system."

As a result, the new position paper concludes, "The 1981 NKF
position paper on fluoridation is outdated. The paper is withdrawn
and will no longer be circulated...." The new paper also states
definitively: "The NKF has no position on the optimal fluoridation
of water. The oral health of people with CKD is certainly of
interest to the NKF, but balancing the overall benefits and risks of
fluoride exposure is the primary concern." The foundation goes on to
recommend additional research on fluoride toxicity, and specifically
advises: "Individuals with CKD should be notified of the potential
risk of fluoride exposure by providing information on the NKF
website including a link to the report in brief of the NRC and the
Kidney Health Australia position paper."

Kidney patients are not the only ones at risk from fluoride
exposure, say many scientists. Infants and young children are
another susceptible population. "[H]uman breast milk has about
1/100th the level of fluoride that so-called optimally fluoridated
water has.... [I]f Mother Nature had intended for human beings to
get fluoride at that level, the human breast would have accommodated
it," says J. William Hirzy, a chemist and fluoride expert at the
American University in Washington, D.C.

"It is now the consensus view of the dental research community that
fluoride's primary benefit to teeth comes from topical application
to the exterior of teeth, not from ingestion through the water
supply," adds Michael Connett, project director of the Fluoride
Action Network.

Connett continues, "Since … the risks are primarily from ingestion …
adding fluoride to the nation's water–and thereby to the bulk of the
nation's processed food–increases public ingestion of fluoride."

Phyllis Mullenix, Ph.D., a neurotoxicologist, former head of the
toxicology department at the Forsyth Dental Center, a world renowned
dental center associated with Harvard Medical School, and currently
a research associate in psychiatry at the Children's Hospital
Medical Center in Boston, reported impacts on the central nervous
system that flagged fluoride as having the potential to cause motor
dysfunction, IQ deficits, and learning disabilities in humans. In a
study published in the Journal of Neurotoxicology and Teratology,
Mullenix showed that fluoride crosses the blood-brain barrier in
baby rats, which–depending on when they were exposed to fluoride
dosages similar to what human children receive–exhibited hyper and
hypo-activity.

In two other studies published in 1999, the same journal noted that
some children exceed the total daily fluoride ingestion simply by
using toothpaste alone. (Commercially packaged toothpastes contain
warnings not to swallow.) The second study found that more than 50
percent of infants are currently formula-fed at one month of age,
and, because of the fluoride in the formula, they "are likely to be
continuously exposed to high intakes of it for nine or 10 months."

Fluoride is also contained in most of our nation's processed and
packaged infant foods and beverages, including "healthy choices,"
such as many fruits and vegetables sprayed with pesticides
containing fluoride. For example, non-organic grapes and raisins are
among the highest fluoride-containing foods eaten by children. Some
sodas are also made with fluoridated water. As early as 1996, the
Journal of the American Dental Association presented data suggesting
that young children who drink substantial quantities of
juice "should not receive dietary fluoride supplements, since they
might be at increased risk of developing dental fluorosis." Another
ADA article from 1997, found high-fluoride-content chicken in infant
food.

More recently, a 2001 study by Oregon State University showed that
foods made with mechanically separated chicken contribute to
fluoride intake, reporting that infant foods had the highest amounts
of fluoride. The study concluded that "a single serving of chicken
sticks alone provides roughly half of a child's upper limit of
safety for fluoride."

Parents may be surprised to learn that the substances used to
fluoridate their water is a waste material, hydroflusilic acid,
taken from the smokestack pollution scrubbers used in the phosphate
fertilizer industry. Hydrofluosilicic acid is classified as a
hazardous industrial waste.

Those wishing to avoid the potential health risks associated with
fluoride may want to consider feeding their children organic foods,
including organic baby foods now carried by many markets. Filtering
water is a bigger obstacle–most common household water filters do
not screen out fluorides. Reverse osmosis water filters are required
to remove or substantially reduce fluorides in the water supply, and
such filters often waste as much as two-thirds of the water being
processed. If choosing fluoridated tooth paste, be certain that your
children use only small, pea-sized amounts and do not allow them to
swallow it.

For more information, check out the following websites: Fluoride
Action Network, www.fluoridealert.org; Citizens For Safe Drinking
Water, www.keepers-of-the-well.org; Scientists, Doctors and
Researchers Warn of Fluoride Dangers, www.nofluoride.com.


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PLASTIC SURGERY


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Nip tuck holiday or medical lottery?

Mon, 21 Jul 2008 6:37p.m.
3 News NZ
Auckland, New Zealand

A scrap is going on in the plastic surgery world. Local surgeons,
versus a medical tourism company that runs nip-tuck tours to Asia.

"Beautiful You Holidays" is giving away $15,000 worth of surgery in
Malaysia. Plastic surgeons say that is unethical and it trivialises
the risks of surgery.

So is it quality surgery at an affordable price, or a medical
lottery which puts your health at risk? The debate over nip tuck
holidays, or medical tourism, has been going strong for years with
no sign of it going away.
In the latest instalment, a new medical tourism company is promoting
itself with a giveaway, a surgical makeover worth up to $15,000 in
Malaysia.

It has raised the ire of the local plastic surgeons who say it is
unethical and it trivialises the importance of surgery.

The company says it is not doing anything illegal and that the
surgeons are only upset because they are being undercut.

"Its a marketing tool, but also for me you know its very rewarding
thing, its nice to see people get something that they couldn't have
the surgery because maybe they couldn't afford it," says Lorraine
Reinsfield of beautiful You Holidays.

It all sounds very appealing, the sunshine, shopping and surgery,
with two recovery weeks in a five star hotel.

But our local plastic surgeons see it differently.

"It just degrades surgery assuming it is a simple thing that you
duck out earn a prize rather like having your hair or your nails
done. There are very serious implications if the wrong operation is
done or it is inappropriately or its inappropriate operation for
that person," says Colin Calcinai from the Association of Plastic
Surgeons.

Colin Calcinai says it is unethical for doctors or surgeons to offer
a prize or inducement to any patient, a stance mirrored by the New
Zealand Medical Council.

But does that apply to surgery done overseas?

We contacted the Department of Internal Affairs which keeps an eye
on sales promotions schemes like this to see if they contravene the
gambling act. It said the way the competition is being run is not
against the law and neither is the prize being offered illegal.
Lorraine Reinsfield believes the real reason surgeons are upset is
because they might lose some business.

"I think the people who go to Malaysia can not afford the price that
they are charging here and if they are upset about that then they
should bring their prices down," says Lorraine.

"There is no question that it will be cheaper to have surgery in
Asia full stop, because the whole cost structure is cheaper, in Asia
there are no regulations that they have to conform to, for example,
they pay their workers next to nothing so they can build hospitals
for next nothing and charge next to nothing," says surgeon Colin
Calcinai.

This is why the industry in Malaysia is growing by 30 percent a
year.
It has caught the eye of the British. Part of the promotional pack
Lorraine and Liz hand out includes UK TV shows following clients to
Kuala Lumpur.

But these are the success stories, surgeons here say they see the
mistakes.

"In terms of people travelling to have surgery yes there are
certainly cases that have come back to new zealand having had
surgery abroad with significant problems and then my members are
obliged to pick up the pieces," says Colin.

Malaysia hit the headlines last year - when a New Zealand woman died
there after obesity related surgery.

It was organised by a different medical tourism company called
Gorgeous Getaways, but the whole industry has felt the effects.

Liz Talifero recently met with the Malaysian Health Minister because
the government there is considering some industry regulation.

"Unfortunately there is no guarantee and there is no guarantee when
the person arrives back in New Zealand with complications," Colin
says.
But that may not stop people entering, Lorraine Reinsfeld's
competition runs all year. But she already has plenty of people
wanting a new body for free.


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BIG PHARMA


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Big Pharma freebies for docs seen driving up health care cost

Published: July 20, 2008
By Edward Mason Staff writer
USA

BOSTON — Free meals, conferences and pens and note pads emblazoned
with the names of the latest prescription drugs are some of the
goodies Big Pharma companies lavish on doctors to get their products
prescribed.

With Massachusetts spending enough on health care to pay for almost
three Big Digs, those freebies are under scrutiny as part of a
sweeping effort to rein in soaring health care costs that was passed
last week by Beacon Hill lawmakers.

A 2006 report by the Boston University School of Public Health
estimates the cost of health care at $62.6 billion a year — the cost
of 2.8 Big Digs at $22 billion each.

Rising costs threaten to undermine the state's landmark health care
law, which requires considerable state subsidies, as Massachusetts
moves toward its goal of insuring all its residents.

Daniel Carlat, a Newburyport psychiatrist, said the House fumbled a
chance for real savings last week when it didn't approve a ban on
gifts to doctors.

"It's all part of the puzzle of trying to contain costs," Carlat
said. "Allowing drug company reps to shower even small gifts has an
effect. It encourages doctors to prescribe new and more expensive
drugs."

The method is subtle, said Carlat, who does not accept gifts from
drug company representatives.

"The psychology is not that you're given a pen or clock and then
say, 'I'm going to return this favor,'" Carlat said. "It's the
visits, the lunches they bring into your office, the gradual process
of buttering up a prospect. It's about a friendly relationship with
your drug rep. You want to reciprocate."

The cozy, boundary-bending relations go back to medical school.
John Raser, a doctor at Greater Lawrence Family Health Center who
graduated from Dartmouth Medical School in 2006, recalls daily lunch
conferences at the school sponsored by pharmaceutical companies.

"There's clearly an influence, even the smaller gifts," said Raser,
who also does not accept drug company gifts. "I consider the pharma
companies sophisticated. They wouldn't spend millions of dollars (on
doctors) if it didn't profit to give those kind of gifts."

The House bill passed last week would ask drug companies to adopt a
voluntary code of conduct limiting gift-giving to doctors, something
Senate leaders say they'll support.

Rep. Patricia Walrath, D-Stow, said lawmakers backed away from an
outright ban following a June biotech conference in San Diego.
There, drug and life sciences company executives protested the ban,
proposed in February by Senate President Therese Murray.

Walrath said pharmaceutical companies argued that a full ban would
deprive doctors of valuable information in one-on-one meetings with
drug company reps.

Alan Sager, director of the Health Reform Program at Boston
University's School of Public Health, said banning gifts to doctors
won't do much — and there are bigger issues.

Health care costs are out of control because the way health care is
delivered is broken, he said. Patients go to specialists when a
primary care physician is more appropriate. And if they did want to
see an internist, good luck. Massachusetts has a glut of specialists
and a shortage of generalists.

The bill lawmakers passed doesn't address any of that, he said.
"This bill will not save serious money," Sager said. "It doesn't
attack the sources of the real problems in substantial ways."

The bill would require that doctors adopt electronic medical records
by 2015. Hospitals would have to report infections patients acquired
to the state. It also includes a program to help doctors repay loans
so they can focus on areas where specialists are in short supply,
such as family practice and obstetrics.

And a commission would devise regulations for treating patients. The
state would reward doctors and hospitals that focused on
preventative care and less on expensive high-tech gadgets, similar
to the way it regulated care in the 1970s and 1980s.

But Mario Motta, a Gloucester cardiologist who is the president-
elect of the Massachusetts Medical Society, doesn't want to see a
total ban on gifts.

He said the Senate version of the health care cost bill went too
far, banning drug samples that he dispenses to help indigent
patients or those who need a dose or two to tide them over. He also
accepts educational material on how to use drugs, which he reviews
first, then pasess along to patients.

Motta said he complies with American Medical Association guidelines
on receiving gifts, which ask doctors not to accept any gift of
value that does not help patients. "As long as it benefits the
patient, there should be no problem," Motta said.

That means drug reps better come to his office with peer-reviewed
articles, not drug company propaganda or lavish gifts.

Motta does accept trinkets like pens and memo pads, which he says
don't influence doctors.

"If you're talking about a fancy paperweight or a clock for the
wall, that crosses the line," Motta said.

Health Care for All research director Brian Rosman said he's
disappointed the gift ban will not make the final bill. But he said
the measure will help corral runaway costs.

"We're encouraged," Rosman said. "It has the potential for leading
to transformative changes."

"It's not going to be quick or easy," Rosman said. "These things
take time."

Time may not be on the side of the state or the nation.

In Massachusetts, employers are balking at Gov. Deval Patrick's
proposal to have businesses shoulder more of the cost of expanded
health care access. And exploding health care costs have made their
way into the presidential race. U.S. Sen. Barack Obama supports
moving the nation toward universal health care.

Pushed aside following the Clinton administration's disastrous
venture into health care reform, health care costs may be the
biggest issue facing Americans.

"It's going to be the major problem the country has to wrestle
with," Motta said. "We'll either solve it in the next year or two or
health care will be in deep trouble."




Thank you for supporting Hadcorp!

http://implants.webs.com/

HADCORP NEWS: July 31, 2008

Leading Story:

French plastic surgeon 'Dr Death' on the run

A manhunt has been launched for a French plastic surgeon nick-
named "Doctor Death" who fled after been found guilty of mutilating
and endangering the lives of at least 90 women.

Telegraph.co.uk
United Kingdom

By Peter Allen in Paris
Last Updated: 9:45PM BST 30 Jul 2008

Michel Maure, 59, is believed to have fled France on his yacht after
a state prosecutor in Marseilles recommended he be jailed for four
years.
Maure was found guilty in June of carrying out dozens of operations
including breast enhancements and liposuction in a dirty, run-down
clinic in Marseilles.

He granted bail until September 8, when he was due to be sentenced,
but breached bail conditions last week, prompting French police to
issue a European arrest warrant.

His girlfriend, their two young children and Maure's 14-year-old
daughter from an earlier relationship are also missing.

Maure has been dubbed Doctor Death in France, where his surname is
pronounced 'mort', which means death.

Maure left his victims physically and psychologically scarred with
failed breast implants, liposuction, facelifts and nose remodelling.
He failed to administer enough local anaesthetic, inflicting severe
agony on his patients, said prosecutors.

The remodelled breast of one woman slid to her armpit overnight, the
court was told, while another found her shoes filling with blood as
she drove home after a terrifying midriff liposuction.

Maure, an anaesthetist by training, was able to operate as a
cosmetic surgeon under a loophole in French law that was closed only
in 2002.
He was found guilty on charges of illegal practice, endangering life
and wounding. His charge sheet listed 96 operations, although many
more are believed to have been botched.

When he was arrested in 2004, Maure boasted to police that he
carried out 300 operations a year and was "one of the great
aesthetic surgeons of the world" and later claimed he was the victim
of a plot by jealous rivals.

"There was no suffering. When you go to the dentist, you suffer.
It's the same with plastic surgery," he said.

"The plaintiffs are women who refused to pay for their operation,
simple thieves."

Prosecutors and victims' lawyers said that Maure, who qualified as a
doctor in 1974, attracted patients with smooth salesmanship and via
an internet site called magicclinic.com. He offered relatively low
rates and easy methods of payment.


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Why the bosom changed its shape?

Times of India
India

29 Jul 2008, 0005 hrs IST, NONA WALIA ,TNN

The bosom has changed its shape! It's not being pushed up, anymore!
But being allowed a bit of natural gravity. Too much of a boob
thing, is a turn-off. The official breast of 2008, is soft, sublte
and natural. And not, pushed up, in your face!

We're living in an age, not many know the real shape of the breast
women carry under their kurtas. After all, we're living in a culture
of Wonderbra. And we're over-exposed to the divas of the cleavage
cult like Pamela Anderson, Sherlyn Chopra, who have made flat-
chested women extinct!

So, are women wearing their breasts differently? What's the official
breast of 2008? Says plastic surgeon Dr Tejinder Bhatti, "The
official breast is natural and not too big. It's not in your face.

While women of Brazil and Argentina want overpowering breasts, those
in India are going in for a subtle change. We get women who want a
soft, rounded and high shape of the bosom."

The West had moved beyond the flat, boyish chest popular during the
1920s, the vital stats of the first Miss America in 1921 were 30-25-
32. In 1970s, it was 34-21-34!

Interestingly, curious things have happened to the bosom shape --
Ayesha Takia reportedly wants to get rid of her big assets, Jessica
Simpson has topped a new poll by a magazine to find the best boobs
in Hollywood, former supermodel Tyra Banks came second, while
actress Scarlet Johansson was third, Carmen Electra was fourth and,
surprisingly, Lindsay Lohan was named fifth.

Just till last season, cleavage was in. Not anymore.

Why even The Guardian reports, there was Elizabeth Hurley, Elle
Macpherson, Cindy Crawford - all women in their 40s, all sporting an
impeccable, mad-for-it cleavage... Now that we've tired of `It
Bags', peachy `It Breasts' have rolled into the public arena. Says
designer Raakesh Agarvwal, "The official breast of 2008, is well-
rounded in a corset. But this corset is covered-up, the breasts
aren't too big, they're subtle, shy and covered. There's rise of
feminity which is not vampish, but proud."

We're living in an age, most celebrities flaunt their assets at the
merest provocation. Yet, the boob overdrive needs to slow down.

Look at the lingerie war -- the winner is the shy, soft, natural
breast. Says fitness trainer, Leena Mogre, "The shape of the breast
in fashion is well-rounded, firm and not sagging. Too much silicon
means they're hard. I tell women, to choose their bras with extreme
care, especially for excercise."

On the catwalk for fall-winter '08, the breast will be higher and
gentler. Says designer Gaurav Gupta, "And the cleavage though very
visible will be veiled in transparent layering."

Sadly, as women try to get perfect breasts off the shelf, implants
and silicon breasts turn-off men like never before, "The natural
breast is the way to be, which sags with gravity and has unique
softness not silicon artificial layering," adds Bhatti.


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Patient sues plastic surgeon and Mass. Hospital

Boston Globe
United States

By Liz Kowalczyk
July 26, 2008

A Beth Israel Deaconess Medical Center patient yesterday sued Dr.
Loren J. Borud, a plastic surgeon with a history of alcohol and drug
abuse, for allegedly performing his operation while impaired.

The patient, Michael K. Hicks of Quincy, said he suffered
complications after liposuction surgery and repair of a scar on his
chest. Hicks also named five other doctors, two nurses, and the
hospital in the lawsuit, saying they realized that Borud was
impaired during an earlier surgery that day and should have stopped
him from operating again.

The state temporarily suspended Borud's medical license Wednesday
for allegedly performing two operations at Beth Israel Deaconess
June 27 while impaired, including Hicks's surgery, and appearing to
fall asleep during the liposuction. During his first surgery that
day, Borud accidentally cut a stitch while closing the patient's
incision, and made no attempt to repair the mistake, the board
alleged.

The hospital fired Borud earlier this month; he had been practicing
for at least six years while struggling with substance abuse
problems, the hospital's board said.

In his lawsuit, Hicks said that he agreed to pay $2,570 for the
elective surgery. According to the complaint filed in Suffolk
Superior Court, Borud told Hicks his surgery would last 60 to 90
minutes, but in the end it turned into an "6 hour and 44 minute
odyssey," completed by medical personnel who were not adequately
trained, skilled, or experienced.

Borud left the operating room in the middle of the surgery, after
closing his eyes twice; a surgical fellow completed the operation,
according to the board.

Hicks said he suffered substantial pain as a result of the surgery,
and had internal bleeding.

Hospital spokeswoman Judy Glasser said she could not comment on
pending litigation.

LIZ KOWALCZYK


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New documentary exposes horrors of botched plastic surgery

New York Daily News
New York, NY, USA
BY ELOISE PARKER
Thursday, July 31st 2008, 4:00 AM

The average cost of cosmetic surgery is from $2,000 to $8,000. But
the cost of having something go wrong during that procedure is
immeasurable.

While the number of people opting to go under the knife annually is
on the rise, so are the potentially disastrous results.

Both issues are major themes in the new documentary, "America the
Beautiful," which opens in theaters Friday and exposes tales of
doctors who call themselves plastic surgeons after taking short
courses in which their only experience may be practicing procedures
on tomatoes.

Former "Today" show guest host Mary Nissenson had a brow-lift at 42
and, 12 years later, is still in agony.

"This man took my entire face off," explains Nissenson in the film,
who says she opted for a surgeon with a "tremendous reputation."

"From the second I opened my eyes, the agony was so extreme, so
excruciating. I wanted to kill myself that second," she says flatly.

Nissenson's still-constant pain was caused by a rare condition
called reflex sympathetic dystrophy (RSD), which can occur when
nerves are damaged.

It spelled the end of her TV career and the end of her marriage,
left her homebound and financially burdened with pain-medication
costs for life.

"I'm completely uninsurable," explains Nissenson.

In New York state, thousands of complaints are filed every year with
medical malpractice lawyers, and a shocking proportion relate to
cosmetic procedures.

"In 2007, we received nearly 2,000 inquiries for medical malpractice
cases and half of them were cosmetic-surgery related," says medical
malpractice attorney Theodore Oshman, of the New York-based Oshman &
Mirisola, LLP.

"Cosmetic surgery is the only area where I have seen an increase in
the number of cases," he adds. "The single most common one is breast
implant cases. Typically, the implant was not placed properly.

The implants may be lopsided, infection may have developed. The next
two areas deal with tummy tucks and rhinoplasty. With the tummy
tucks, the most common complaint is infection and colloidal
scarring."

When Marion, 30, whose name has been changed, opted to get breast
implants last year, she chose a surgeon recommended to her by three
people she knew. "He'd even been interviewed on television. ... He
said 'It's simple, there'll be no scarring, you're healthy, I do
this a million times a day,'" says the New Jersey native.

"During the recovery process, my areolas started detaching,"
explains Marion. "I've basically lost feeling in my breasts around
the areola."

The surgeon who performed the operation was later arrested for
malpractice and drug possession and has since been shut
down. "Looking back, it wasn't worth the financial and emotional
difficulties," says Marion. "Everyone always told me little things
could go wrong, but no one really tells you the nightmare stories."

Chris, 55, from Albany, was left paralyzed down the right side of
her face after a botched face-lift.

"I'd never do it again. I went into this to feel good, and it's been
agony," she explains "The surgeon said she was board certified. She
said she was as good as California and NYC doctors and had never had
a problem."

"The term 'board certified' can be deceptive," explains Dr. Richard
D'Amico, president of the American Society of Plastic Surgeons
(ASPS), which represents just over 6,700 members, each of whom must
undergo at least six years of specialist training, several
examinations, presentation of multiple case studies and continued
assessments. "You have board certified podiatrists who may be
working as plastic surgeons and don't have to say what board they're
certified by unless they're asked."

He suggests taking the following three steps; "First, look for an
ASPS certified surgeon." The American Society of Plastic Surgeons
Web site(plasticsurgery.org)is a user-friendly resource for starting
your search.
Second, check out accredited facilities where the surgery will be
performed, at online resources like the American Association for
Accreditation of Ambulatory Surgery Facilities Web site
(aaaasf.org).

Finally, ensure you have a thorough preoperative evaluation,
including laboratory tests. Sometimes, even if the procedure is done
properly, pre-existing conditions may be a detriment in recovery.
Last year, Kanye West's mother, Donda, died in recovery after a
routine liposuction, tummy tuck and breast reduction surgery.
According to her autopsy, her death was likely caused by
complications connected with heart disease. So knowing your own
personal medical history is crucial, before going under the knife.


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Plastic surgery clinics closed down

ArabianBusiness.com
Dubai, Umm al Qaiwain, United Arab Emirates

by Sean Cronin on Tuesday, 22 July 2008

Health inspectors have closed several plastic surgery clinics and
withdrawn licenses from some doctors as part of a move to impose
tougher regulations on the industry.

The Department of Health and Medical Services, part of the new Dubai
Health Authority, is monitoring around 1,000 clinics that have
opened in Dubai, UAE daily the National reported.

Among the cases investigated by the department were a female patient
who went into a coma after undergoing liposuction and another 27 yr-
old Emirati woman who died after having the same treatment, the
newspaper said, citing Dr Ramadan Ibrahim Mohamed, the head of the
department's clinical governance office.

Seven people are before the Dubai courts accused of negligence
arising from the death of the woman.

The authority fears that cases of negligence or malpractice may be
under-reported because patients have been afraid to report such
cases for family or cultural reasons.


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MORE MEDICAL NEWS


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Lawsuit settled over scalding death of mental patient

St. Louis Post-Dispatch
MO, United States

By Carolyn Tuft
ST. LOUIS POST-DISPATCH
07/23/2008

ST. LOUIS — A federal lawsuit that accused state workers of scalding
to death a mentally and physically disabled man during a bath has
been settled out of court.

The man, Rutherford "Rudy" Wallace, 24, died March 16, 2006, after
being bathed in scalding water by a worker at the state-run
Northwest Habilitation Center for the mentally disabled.

The worker initially did not call for medical help and Wallace died
in a hospital days later.

Wallace could not walk or talk and was mentally retarded.

Wallace's mother, Linda Harris, sued the state and the workers in
June 2006. The state agreed to pay Harris $655,000 in the case,
according to federal court records. Powers Hydroguard, the company
that made the device that allowed the scalding water to go through
the pipes, agreed to pay damages to Harris, but that amount has been
kept secret.

The settlement was approved by U.S. Magistrate Mary Ann L. Medler.

Wallace's death was ruled a homicide by the St. Louis County medical
examiner, but no charges have ever been filed in the case. The
Justice Department has been investigating, but the results of its
inquiry have not been made public.

The Northwest Habilitation Center is run by the Missouri Department
of Mental Health and is located in unincorporated St. Louis County
near Overland. It cares for some of the state's most severely
disabled residents.

Harris was unavailable for comment. Kurt Wolfgram, who represents
her, said Tuesday, "I think that this case brings to light the
plight of the voiceless in our state mental health system. It's good
for the public to know what is really going on in these homes."

Wolfgram credited a 2006 St. Louis Post-Dispatch investigation that
detailed Wallace's case and others where people died while under the
care of state workers. The newspaper investigation and subsequent
state and federal investigations found serious lapses in the
Department of Mental Health's system designed to protect mentally
disabled residents in the state's care.

Bob Bax, a spokesman for the Department of Mental Health, and other
top officials for the department have called Wallace's death a
serious breach and said that workers were fired over the case and
have been banned by the state from working with other disabled
residents.

He said Tuesday that the state is working to assure that all clients
are free from abuse and has been continuing to make improvements as
outlined by the task force set up after the newspaper's
investigation.

Bax also said that the state attorney general made the decision to
settle the Wallace case and that the Justice Department has not
finished its inquiry into Wallace's death.

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STANFORD HOSPITAL, DOCTORS, SUED FOR WRONGFUL DEATH, FRAUD "FAILURE
OF CHARACTER" says Victim's Son

Mass Media Distribution LLC (press release)
Naples, FL, USA
July 28, 2008

San Francisco California -- July 28, 2008 --

Stanford University Hospital and Clinics, Stuart Goodman MD, Eric
Stuffman MD, Daniel R. Hamman MD, were named Defendants in a lawsuit
filed in San Francisco Superior Court. The 31page complaint alleging
Wrongful Death, Fraud, Fraud and Deceit, and Negligent Infliction of
Emotional Distress was filed on behalf of the family of Diane
Stewart. Ms. Stewart died of an incarcerated small intestine at
Stanford Hospital on April 3, 2007.

Ms. Stewart entered Stanford Hospital on March 30, 2007 for knee
replacement surgery. In the evening of March 31, she "began
experiencing nausea, lack of appetite, and vomiting, among other
symptoms, which were recorded by her health care providers". The
next day Ms. Stewart reported the "abdominal pain she was
experiencing as being a 10 … (10 being severe pain)". Other
increasing symptoms of distress included "urine output had dropped
dramatically, blood oxygen levels were low; … drops in her blood
pressure and elevated heart rate." About noon on April 1, family
members requested "Defendants to have an abdominal x-ray or similar
taken as they feared that the pain experienced by the decedent was
an indication of appendicitis or another serious condition." "…
Defendants denied the request for x-ray and/or no other diagnostic
test was conducted. "

The complaint continues that in mid afternoon on April 1, 2007, Ms.
Stewart told "one or more of the Defendants that her abdominal pain
was 8 or higher and her knee pain was 3. The health care provider
replied that he was not concerned with her abdominal pain". When a
family member asked a nurse to contact a doctor, the nurse informed
her ,"…the team responsible for decedent's care was aware of the
abdominal issues, that the pain was being caused by `ileus' and that
two doctors, Defendants Stuffman and Hamman, had been contacted and
they had taken a course of no action other than palliative medical
treatment". Despite repeated requests from Ms. Stewart and family
members, that she be examined and evaluated by a doctor, they were
informed by the nurse … "that their job was to manage the pain and
not to do anything else and directed Decedent to use the Patient-
Controlled Analgesia or `PCA' device to administer pain medication".
All this time, family members were assured that the "decedent was
having a bad reaction to the anesthesia used for surgery and that
everything was fine".

Plaintiffs allege that during the night of April 1 when Ms.
Stewart's blood pressure dropped to within a range requiring
notification of a doctor, "…Defendants … failed to notify a doctor
and/or take other steps within the standard of care".

The complaint continues that on the morning of April 2, 2007 Mrs.
Stewart was moved to the Intensive Care Unit "where she died shortly
thereafter from an incarcerated small intestine. The symptoms of
which the Decedent complained and/or her family asked to be
examined, diagnosed, and or treated were symptoms which Defendants
knew and/or should have known to be indicative of an incarcerated
small intestine which has an extremely high risk of death if left
untreated".

The complaints of Fraud arise from allegations that Stanford
Hospital and the other defendants attempted to cover up their
negligence/misfeasance by altering Ms. Stewart's medical record.

The family expressed satisfaction their case had finally been filed
despite the obstacles created by California's Medical Injury
Compensation Reform Act of 1975 (MICRA). Holly Carey, Ms. Stewart's
daughter, told of the difficulty just to hire a lawyer. "When we
started this process", said Ms. Carey, "we had no idea that the
MICRA law was so unfair. The ridiculously low limit on lawyers' fees
made it almost impossible to retain an attorney. MICRA definitely
stacks the deck in favor of the big institutions – hospitals,
insurance companies, and doctors," Ms. Carey continued. "We
discovered that when the victim is old, and retired, as was my
mother, most lawyers cannot afford to accept cases that are
controlled by MICRA ."

Mrs. Stewart's son, David, himself a licensed physician, bitterly
recalled the tragic circumstances of his mother's death. "I know
from my own experience that surgery is a risky business. A slip of
the knife or a wrong diagnosis of a patient's condition can be
failures of training or education and sometimes forgiven. In my
mom's case I believe her doctors' inexplicable refusals to respond
to the cries for help from their patient suffering 10 level pain,
and the desperate pleas from family members were failures of
character and are unforgivable."

Note to editors: The complaint (Case No. CGC08-475755) can be viewed
or downloaded by entering case number 475755 on the Case Information
page of the San Francisco Superior Court website
http://www.sfgov.org/site/courts_index.asp


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LegalView Reports Details of Failing Artificial Hip Component Known
as the Zimmer Durom Cup

PR.com (press release)
Levittown, NY, USA

LegalView informed readers of Zimmer Holding's suspended sales of
its artificial hip component, the Durom cup, because of reports from
physicians that the part was failing and/or faulty. The device,
which is a hip socket, has been under investigation by the company,
who continued to claim it was not defective.

Denver, CO, July 30, 2008 --(PR.com)-- LegalView.com, the number one
legal resource available on the Web, recently informed readers of a
potentially faulty hip socket known as the Zimmer Durom cup. Zimmer
Holdings announced it would "suspend sales of the artificial hip
component" because of continued complaints by physicians that the
hip socket was failing or faulty, according to reports in The New
York Times. Individuals who may have been affected by the potential
Durom cup failure should consider speaking with an experienced law
firm about the development of a potential Durom cup lawsuit in which
monetary compensation could be an outcome.

According to reports in The New York Times, the Durom cup has been
available for only a couple of years, since 2006. However, since
that time, more than 12,000 individuals have received the artificial
hip component and had it implanted into their bodies. Patients that
have undergone a hip replacement surgery and may be affected by the
potential Durom cup recall should speak with their physician
immediately to reduce the risk of harm because of the hip socket
failure. Additionally, legal counsel may be a way to avoid being
stuck with unnecessary medical bills because of a faulty artificial
hip component.

Patients can learn more about this and a variety of other legal
issues by visiting LegalView's other information portals. Some of
the most recently updated information portals available through the
LegalView legal library include information on obtaining a truck
accident attorney or how to cope with a traumatic brain injury.
Additionally, LegalView offers an extensive library of resources on
pharmaceutical issues including the Cipro warning.

LegalView recently launched a site on truck accidents, as the
unfortunate number of truck accidents have continued to rise in
numbers across the country. According to research from the United
States Department of Transportation (USDOT), the number of truck
accidents has been increasing over the last 10 years. It is also
reported that truck accidents, specifically tractor-trailer truck
accidents, are among the most costly and fatal of all accidents,
which is why LegalView provides information on how to find a truck
accident lawyer.

In the United States, there are millions of individuals who have
suffered from a traumatic brain injury (TBI) incident. The LegalView
information portal can help those who need a traumatic brain injury
lawyer. The effects of a TBI can range from the small - such as
concussions, headaches - to severe, including long or short term
memory loss, loss of motor skills and physical abilities/functions,
depression, mental disintegration, comma or even death. The
LegalView information portal provides research on the latest TBI
recovery methods and scientific research to help individuals cope
with TBI.

Also, LegalView also has pharmaceutical portals that offer
insightful details as to the latest Food and Drug Association (FDA)
news or recalls. Most recently, a group of antibiotics known as the
fluoroquinolones have had a warning label increase, being affixed
with a black box warning label, which is the harshest warning from
the FDA. Among the antibiotics is Cipro. The antibiotic is used to
treat an array of bacterial infections. However, it received the
black box label because of its link to Achilles tendonitis among
patients. Those who may have suffered from the Cipro side effect are
encouraged to speak with their doctor immediately.

About LegalView: LegalView.com is a public service brought to you by
Legal WebTV Network, LLC, a Limited Liability Corporation created by
a group of the nation's most highly respected law firms: Anapol
Schwartz; Brent Coon and Associates; Burg Simpson; Cohen, Placitella
and Roth; James F. Humphreys and Associates; Lopez McHugh; and
Thornton and Naumes. For more information on the accomplishments and
track records of LegalView.com's superior sponsoring law firms and
to get in touch with LegalView attorneys, visit LegalView at
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Integrity in Science Watch Week of 04/21/2008


Headlines
JAMA Editors May Ban Authors Who Hide Financial Ties

Medical Firms Disclosure Offers Fall Short of Proposed Bill

BPA Safety Concerns Continue to Grow

FDA Medical Device Panel Issues Conflict of Interest Waivers

Odds and Ends

Cheers and Jeers



JAMA Editors May Ban Authors Who Hide Financial Ties

Amid revelations that Merck employed ghost-writers on dozens of
published Vioxx studies and that a company-funded review allegedly
manipulated data to hide the drug's dangers, the editors of the
Journal of the American Medical Association last week called for
steeper penalties on authors who fail to disclose conflicts of
interest, hide or manipulate data, or claim to have done work
actually done by others. The proposed penalties ranged from
requiring public letters of apology to a ban on publishing in the
journal. "When integrity in medical science or practice is impugned
or threatened—such as by the influence of industry—patients,
clinicians, and researchers are all at risk for harm, and public
trust in research is jeopardized," editor-in-chief Catherine
DeAngelis and deputy editor Phil Fontanarosa wrote. The editorial
marks a hardening attitude by some journal editors toward repeated
failures by scientists to reveal their financial ties to industry
(see this week's Cheers and Jeers below). In August 2006, DeAngelis
rejected a ban on authors who failed to disclose conflicts of
interest, claiming authors would simply seek out other journals. "It
cleans our house by messing others," she wrote then.

The shift was triggered by two studies in the latest JAMA, and came
just a few weeks after the journal published corrections involving
radiologists who failed to disclose their lung cancer screening
study had been funded by the tobacco industry. One new study
contended that Merck minimized deaths among patients who had been
given Vioxx by manipulating pooled data contained in clinical trials
involving Alzheimer's and dementia patients. The second article
found that Merck employees or a Merck contractor, Scientific
Therapeutics, prepared manuscripts and then recruited academic
researchers as authors. Despite playing a minimal role, the
recruited academics were frequently listed as first or second
authors when the articles appeared in print. Both studies relied on
documents obtained in court suits. Merck rejected the studies'
findings, noting that five of the authors consulted for plaintiff
attorneys and a sixth testified against Vioxx before a Senate panel.
Sen. Chuck Grassley (R-IA) seized on the latest revelations to
demand that Merck and Scientific Therapeutics turn over all
documents related to the studies by May 2.

Medical Firms Disclosure Offers Fall Short of Proposed Bill

A dozen of the nation's leading pharmaceutical and medical device
companies announced plans last week to disclose financial gifts and
grants to physicians. But nearly all stopped short of meeting
requirements in legislation that was introduced in Congress earlier
this month. At least one company – Schering-Plough Corp. – refused
to go along with industry's voluntary efforts. In a letter to the
Senate Aging Committee, the company said it has no plans to publish
charitable contributions or education grants. Sen. Charles Grassley
(R-IA) and Sen. Herb Kohl (D-WI), sponsors of the Center for the
Science in the Public Interest- supported Physician Payments
Sunshine Act, would require drug and medical device manufacturers to
publicly post all gifts and payments to doctors over $25. Although
the legislation does not prohibit financial ties between doctors and
drug companies, those who do not disclose those payments could be
penalized at least $10,000.

Most companies' voluntary programs fell well short of the bill's
requirements. Medtronic Inc. and AstraZeneca PLC told Grassley they
will post payments for professional meetings and patient groups this
summer, but not payments to individual doctors. Merck said that its
plan was still being developed, while Amgen and Abbott Laboratories
have formed working groups to examine the issue. Only Boston
Scientific said it was developing a system to disclose payments to
physicians. Zimmer Inc. and Stryker Orthopedics Inc. have reached an
out-of-court settlement with the U.S. Justice Department that
requires disclosure of physician payments. Watchdog groups described
the industry response as inadequate and an attempt to sidetrack the
legislation.

BPA Safety Concerns Continue to Grow

The National Toxicology Program (NTP) last week issued a preliminary
finding that bisphenol-A (BPA) can lead cancer, hormonal and
neurological problems, as well as behavioral changes in animals. The
chemical, used in many plastic bottles, food containers, and linings
of food cans, has been found in the urine of 93 percent of
Americans. "There is some concern for neural and behavioral effects
in fetuses, infants and children, at current human exposures," the
report noted. However, the draft brief emphasized that more research
is needed to truly understand BPA's impact on human health at
current concentration levels. In light of the NTP report's
conclusions, the House Committee on Energy and Commerce chaired by
John Dingell (D-MI), called on the FDA to reconsider the safety of
BPA. "These findings of BPA's dangers are based on the totality of
research around this chemical," Dingell said. "I hope the FDA is
willing to reconsider their position on BPA for the safety of our
infants and children." The Canadian government plans to declare BPA
as toxic. Wal-mart said that its entire assortment of baby bottles
will be free of the material by the early next year; and two major
manufacturers, Playtex Infant Care, and Thermo Fisher Scientific
said their products will be free of BPA by the end of the year.

FDA Medical Device Panel Issues Conflict of Interest Waivers

The Food and Drug Administration has issued conflict of interest
waivers for three members of the Ophthalmic Devices Panel for its
meetings later this week. On April 24, the panel will review an
implantable miniature telescope (IMT) manufactured by VisionCare
Technologies that can be used to correct vision impairment. David
Musch, an associate research scientist at the University of Michigan
School of the Public Health, received a conflict of interest waiver
because the University of Michigan served as a site for a clinical
trial of the IMT. Although Musch did not help conduct the study, his
supervisor, Paul Lichtor, served as the principal investigator and
the university received between $101,001 and $300,000 from
VisionCare Technologies. Similarly, Neil Bressler, a professor of
ophthalmology at John Hopkins University School of Medicine,
received a waiver because his hospital served as a clinical site for
the IMT trial and received a grant under $100,000 from the company.
On April 25, the panel will discuss post-market feedback of phakic
intraocular lenses and laser-assisted in situ keratomilesis (LASIK)
surgery. Dale K. Hever, chairman of the Department of Ophthalmology
at the Medical College of Wisconsin, received a waiver after taking
a speaker's fee of up to $10,000 and consulting for an undisclosed
firm involved in the sight-correcting processes.

Odds and Ends

A half dozen consumer groups, including the Center for Science in
the Public Interest, Consumers Union, and the Government
Accountability Project, sent a strongly-worded protest to the Food
and Drug Administration opposing a draft guidance that will govern
how industry can promote the off-label use of drugs and devices. The
proposal would lower the criteria and drop agency review of journal
reprints on off-label uses that could be given doctors by drug and
medical device industry salespeople . . . . Sen. Herb Kohl (D-WI)
and Sen. Robert Bennett (R-UT) agreed last Tuesday at a Senate
Appropriations subcommittee hearing that the Food and Drug
Administration needs more funding. The Bush Administration has
proposed increasing the agency budget for next year by only 3
percent, which FDA commissioner Andrew C. von Eschenbach, said would
not even cover increased costs . . . . Organon failed to inform the
FDA and the public about potentially fatal side effect of it
neuromuscular blocking agent, Raplon, which was taken off the market
in March 2001. Jeffrey Feldstein, the company's associate director
of medical services for antithrombotics, leveled the charges in a
lawsuit filed in the New Jersey federal court against Organon and
Schering-Plough, which acquired the company . . . . House Energy and
Commerce Committee chairman John Dingell (D-MI) is wondering if
Merck and Schering-Plough made up minutes of a November 2007 meeting
of medical advisers called to discuss the cholesterol medication,
Vytorin. The minutes in question were actually written in December
2007 and have been contradicted by one of the meeting's attendees,
James Stein, a University of Wisconsin professor . . . . The British
Medical Journal reported last week that Andrew Wakefield, the doctor
behind the late 1990s collapse of public confidence in measles,
mumps, and rubella vaccine, will soon go before a General Medical
Council fitness-to-practice panel. The doctor, along with the two
other authors of a 1998 Lancet study on inflammatory bowel disease
and autism, is accused of professional misconduct for falsifying
data . . . . The EPA's Inspector General (IG) is now investigating
the agency's much criticized decision to remove Deborah Rice from a
Maine scientific peer review panel at the behest of the chemical
industry trade group, the American Chemistry Council. The
investigation was triggered by a letter from the EPA's Deputy
Administrator asking the IG to determine if Rice removal was
consistent with existing federal laws and guidelines. The panel was
reviewing the safety decabrominated diphenyl ether, a common flame
retardant . . . . Leaders of the American College of Occupational
and Environmental Medicine are speaking out against industry
pressure to underreport workplace injuries, and have scheduled a
meeting with top officials at the Occupational Safety and Health
Administration next month to press their concerns, the Charlotte
Observer reported.

Cheers and Jeers



Jeer to Perry Pickhardt, associate professor of radiology at
University of Wisconsin School of Medicine for failing to disclose
in an Archives of Internal Medicine article that he works as a paid
consultant to Covidien, Viatronix, Fleet, Medicsight, and Philips.
All five companies manufacture products or have developed
technologies used in computed tomography for colon cancer screening,
which was the subject of Pickhardt's article. The Archives editor is
investigating.


Cheer to David Armstrong of the Wall Street Journal for revealing
ties between the tanning industry and a Boston University
researcher, Michael Holick, who recommended the moderate use of
tanning beds as a way to treat or avoid vitamin-D deficiency in a
New England Journal of Medicine article. Armstrong discovered that
Holick received financial support from a non-profit organization,
the UV Foundation that is funded by the Indoor Tanning Association
and makers of indoor tanning beds, which was not disclosed in the
journal.


Jeer to David Brown of the Washington Post for failing to note the
Joshua T. Cohen, a member of Center for the Evaluation of Value and
Risk in Health (CEVR) at Tufts-New England Medical Center, has
recieved research funding from numerous corporations including
unrestricted grant support from Johnson & Johnson and Amgen through
CEVR. Cohen was quoted by Brown in his Health section lead article
questioning the cost-effectiveness of many forms of preventive care.


Cheer to Andrew Pollack of the New York Times for disclosing that
Jayakrishna Ambati, a professor of ophthalmology at the University
of Kentucky, works as a scientific consultant Allergan and Quark
Pharmaceuticals. The two drug companies are currently working on a
new medical technique, RNA interference, on which Ambati recently
published a study on in Nature.


Jeer to the Wall Street Journal and Patrick Michaels for failing to
disclose in an op-ed on April 18 downplaying global warming risks,
that Michaels has many ties to industry in addition to being a
senior fellow in environmental studies at the Cato Institute and
professor of environmental sciences at University of Virginia.
Michaels has received funds from industry groups including the
Intermountain Rural Electric Association and the Western Fuels
Association.


Integrity in Science Archives

The Integrity in Science Database of Scientists and Organizations
WIth Ties to Industry can be found at: www.integrityinscience.org.
Please circulate. To subscribe to Integrity in Science Watch or to
send tips for inclusion in the Database, please send an email to
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in the subject line.

Scientists Tie Breast Implant to Cancer

LinkedinDiggFacebookMixxYahoo! BuzzPermalinkBy PHILIP J. HILTS,


Scientists for the Food and Drug Administration have determined that
a kind of cosmetic breast implant that hundreds of thousands of
American women have received over the last two decades breaks down
in the body to produce a substance that has been shown to cause
cancer in laboratory animals.

Word of the finding, confirmed in interviews with scientists in and
out of the Government who are familiar with the data, follows
hearings before a House subcommittee last month at which F.D.A.
officials first raised the possibility of a cancer risk from the
implant.

Investigators for the House panel, the Government Operations
Subcommittee on Human Resources and Intergovernmental Relations,
estimate that three million American women have breast implants, and
that 25 percent of all implants are the kind that are tied to a
cancer risk by the latest findings. Coated With Polyurethane

This implant is made by Surgitek, a subsidiary of the Bristol-Myers
Squibb Company, and is sold under the trade names Meme and Replicon.
Like many other breast implants, it is essentially a blob of
silicon. But it is also coated with a polyurethane foam that is
intended to prevent development of a painful and unsightly lump that
frequently forms after breast implant surgery.

It is this coating that dissolves in the body, the F.D.A. scientists
have now found. As it does so, it produces a chemical, 2-toluene
diamine, or TDA, which has been shown to cause liver cancer in rats
and other research animals.

A spokeswoman for Surgitek, which is based in Racine, Wis., said the
company's tests had found that dissolution of the polyurethane was
minimal. She said Surgitek continued to believe that its product was
safe.

An announcement of the Government scientists' finding and
recommendations on which course women with a Meme or Replicon
implant should now pursue, is not expected from the F.D.A. for days,
or even weeks.

A spokeswoman for the agency, Susan Cruzan, would neither confirm
nor deny the finding. She said data from the F.D.A.'s experiments
were being urgently reviewed to determine whether the implant should
be withdrawn from the market.

But scientists familiar with those experiments said it appeared from
preliminary calculations that the implant might cause cancer at the
rate of 200 to 400 cases a year for every million women in whom it
is inserted.

Researchers who have worked on the dangers of breast implants, both
for the Government and privately, said that the best course for
women who have a Meme or Replicon implant was probably to do nothing
until the F.D.A. issues recommendations.

These scientists, including Nir Kossovsky, a pathologist at the
University of California at Los Angeles, noted that there was a
danger of disfigurement in surgical removal of any breast implant.
Further, they said, continuing to carry the implant for a few more
weeks will not add significantly to the cancer risk. Other Action on
Implants

Word of the Government scientists' finding comes only days after the
F.D.A. took other action against breast implants. In a directive
issued this week, the agency gave makers of all breast implants 90
days to demonstrate that the products are safe or remove them from
the market.

One issue in that directive is evidence that silicon seeping from
the implant can make its way into the lymph nodes and disrupt the
immune system.

Another is that if the silicon is not coated, breast tissue can grow
around it, leading to muscle contracture that creates a painful
lump.

Government experiments with the Surgitek implants followed findings
by private doctors that some of the coating had dissolved when the
implants were removed from patients. The F.D.A. scientists, whose
work on the matter lasted for months, found similar dissolution when
the implants were placed in a liquid at body temperature.

The F.D.A. data show that the dissolution of the polyurethane begins
immediately after implantation and that in some cases, depending on
factors not fully understood, the coating may dissolve almost
completely within five years. The greater the rate of dissolution,
the greater the cancer risk, the scientists said they believed.

But the Surgitek spokeswoman, Karen Garoukian Ferraro, said the
company's studies had brought far different results.

She said that doctors working for the company had examined 10 of the
implants after they were removed from patients and that the doctors
had found that the "structural integrity of the polyurethane remains
intact."

Microscopic examination, she said, showed that some of the
polyurethane had dissolved in the body. But she said this process
had been a very slow one.

Mrs. Ferraro also said that from other Surgitek studies, which
examined dissolution of the coating in a laboratory, the company had
calculated that the number of cancers caused by the release of TDA
into the body would be "one in several million implants," a far
lower rate than found by the F.D.A.

http://query.nytimes.com/gst/fullpage.html?
res=9D0CEEDC1338F937A25757C0A967958260&sec=&spon=&pagewanted=2

Conflicts cause FDA to review advisory committees
Wayne Kondro
CMAJ

Critics have lately cast the US Food and Drug Administration (FDA)'s
scientific advisory panels as little more than partially owned
subsidiaries of the pharmaceuticals industry. In fact, one
influential US Congressman is so outraged by the degree to which
panels are replete with scientists who sport financial conflicts of
interest that for the second consecutive year, he has successfully
attached a rider to the FDA budget that would prohibit the agency
from using panelists so conflicted.

Facing a political firestorm stoked by conflicting studies1 and a
barrage of negative publicity,2–5 the FDA in May announced a major
internal review of its Advisory Committee Meeting system, its
typical means of garnering expert advice on scientific issues around
drugs. Roughly 20% of the 35– 40 new "chemical entities" approved by
the FDA each year are subject to external panel review.

Among aspects of this major review are an examination of the FDA's
appointment process for the members of its 16 drug committees and 32
other advisory panels, and whether it needs to modify its practices
for handling conflicts of interest among panelists.

Currently, the FDA allows conflicted scientists to apply for
a "waiver" that permits them panel membership on the grounds that
their individual expertise outweighs the seriousness of the
conflict. Health Canada allows similar exemptions, although without
a formal waiver process. Rather, conflicts are publicly declared or
limits are placed on an individual "in the development of the
panel's advice through a variety of mechanisms under the direction
of the panel chair," says spokesperson Carole Saindon. She adds that
Health Canada's approach to conflicts of interest is more rigorous
than that of similar organizations in other nations,
since "candidates who could receive direct financial benefit from a
regulatory decision [such as company shareholders] are excluded from
panel membership."

Such an automatic prohibition does not appear to be the goal of the
FDA review. Spokesperson Crystal Rice says that the agency has no
intention of changing its policies to prohibit conflicted scientists
from serving on a panel, but will examine "our processes and
procedures for implementing the current laws."



Figure. US Congressman Maurice Hinchey (Democrat–NY), critic of the
Food and Drug Administration. Photo by: Canapress



That, however, is unlikely to satisfy critics, led by Congressman
Maurice Hinchey (Democrat–NY), a member of the influential House
Appropriations Committee, who hold that such conflicts completely
compromise the value of scientific advice. Last fall, Hinchey
convinced the US House of Representatives to deny budget
appropriations to the FDA unless it discontinued its practice of
granting waivers. But in a subsequent political compromise with the
Senate, reached during the budget process, the rider was lifted on
the proviso that the FDA disclose potential conflicts and post them
on its Web site 15 days before each meeting. The issues of an
outright prohibition of participation by conflicted scientists and
FDA's use of waivers were referred to the powerful Government
Accountability Office for review.

Since then, a new study1 found that in 2001–2004, the FDA recused
less than 1% of conflicted scientists; and that, of the roughly 3000
advisory committee members who participated in the FDA's 221 drug-
review meetings, some 28% had a conflict of financial interest with
the affected company or product competitors within the preceding
year. In the wake of that report, Hinchey again mustered enough
political support to attach an identical rider in May to the FDA
budget covering the 2006/07 fiscal year.

Although many laud the openness and transparency of the FDA's
advisory committee system as an example to the world, the betting is
that the agency's international reputation will not permit it to
escape politically imposed change, especially after its recent
avalanche of controversies. One was the study published in April by
Peter Lurie (deputy director of the Washington-based consumer-
advocacy Public Citizen's Health Group) and colleagues,1 which found
that conflicts of interest are rampant within FDA drug panels: in
2001–2004, a financial conflict of interest with the affected
company was had by one or more panelists in 73% of the 221 drug
reviews conducted by the FDA's 16 advisory committees. Only 1% of
members were recused, although many conflicts were substantial: some
30% involved investments exceeding US$25 000; another 23%, grants or
contracts topping $100 000. Lurie and colleagues nevertheless
concluded that the outcomes of votes by the Center for Drug
Evaluation and Research advisory committee essentially were
uncompromised: excluding conflicted panelists would not have changed
outcomes, but only reduced the vote margins.1

Another controversy involves an examination by the Center for
Science in the Public Interest (CSPI),2 at the request of the New
York Times, of a 32-member panel that had studied the cardiovascular
risk of COX-2 inhibitors, controversial painkillers that include
celecoxib (Celebrex), refecoxib (Vioxx) and valdecoxib (Bextra). Its
widely publicized conclusion was that the panel would have voted
differently on whether the drugs should be on the market if the 10
members with direct financial interests in the drug manufacturers
had been excluded from participation.

Another storm began in March of this year when David Graham,
Director for Science and Medicine of the Office of Drug Safety (and
an FDA whistleblower), told the National Press Club that the Office
of New Drugs (OND)'s authority over FDA advisory committees is
heavily biased in industry's favour. In calling for structural
reforms to provide more separation between the drug safety and drug
review functions of the FDA, Graham said the OND had too much
control over panel appointments, the assignment of drugs to specific
committees and what information is presented to panelists. He also
criticized the FDA's financial disclosure rules as being lax.

Other conflict allegations have been made about the advisory panels
studying silicone breast implants,3 the labelling of high-blood-
pressure drugs4 and of Tysabri,5 a drug to treat multiple sclerosis.
Much of the ensuing debate has focused on whether prohibiting
conflicted scientists from sitting on a panel would, because the
pool of available experts is limited, compromise the quality of
scientific advice ultimately received. Merrill Goozner, CSPI
Director of Integrity in Science, dismissed that notion as
disingenuous, calling it offensive to suggest that only the best and
brightest work for industry. There is a plethora of qualified and
nonconflicted experts, he says, and the FDA is reluctant to expand
panel membership to include more epidemiologists. "This should be
turned into more of a deliberative body without a stake in the
outcome, rather than a kind of good-old-boy network of people whose
primary interest is to get their hands on a new therapy, either to
test or for [their own] patients."

Peter Lurie is convinced that the FDA must move to broaden committee
composition and adopt more stringent standards for determining when
waivers will be granted, rather than automatically rubber-stamping
them, as now appears the case. "A person goes on an advisory
committee and they don't know what votes are going to come up in the
future," he points out. "To ensure [a panel] without conflict of
interest is either to recuse absolutely everybody, no matter how
remote the conflict of interest, or to never allow anybody who's
ever had any investment, of any kind, on the committee in the first
place, in the possibility that a drug in which they've been involved
might later come up." Because that is simply impractical, he
adds, "there needs to be more hard-and-fast rules about who will be
recused — and the barriers should be set lower."

Yet, change is unlikely to come from within the FDA, Lurie
forecasts. "The most striking thing about this ... is that the FDA
thinks that an internal committee to review an external advisory
committee process is the way to go. It's just totally illogical, and
it really raises questions about the sincerity of the effort."

REFERENCES


Lurie P, Almeida CM, Stine N, et al; Public Citizen's Health
Research Group. Financial conflict of interest disclosure and voting
patterns at Food and Drug Administration Drug Advisory Committee
meetings. JAMA 2006;295;1921-8.
Harris G, Berenson A. Ten voters on panel backing pain pills had
industry ties: the 10 government drug advisers with company ties
voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's
return. New York Times 2005 Feb 25. An article of the same topic,
date and authorship is available: www.sfgate.com/cgi-bin/article.cgi?
f=/c/a/2005/02/25/MNGJTBGQ7H1.DTL (accessed 2007 June 7).
Eggertson L. Breast implant advisory panel: more study on silicone
leakage [news item]. CMAJ 2006;174(4): 443-4.[Free Full Text]
Center for Science in the Public Interest. FDA panel investigating
labeling of antihypertensive drugs stacked with industry
consultants: draft guidance may miss opportunity to educate
Americans about importance of lifestyle, diet on high blood pressure
[press release]. Washington: The Center; 2006 Apr 24. Available
through www.cspinet.org/integrity/press_releases.html (accessed 2007
June 7).
Henderson D. No end to FDA disclosure debate: new waiver law fails
to quiet criticism over experts' financial ties to drug companies.
Boston Globe 2006 Apr 21. Available:
www.boston.com/business/articles/2006/04/21/no_end_to_fda_disclosure_
debate (accessed 2006 June 7).






Of course we know nothing will come from this nor came from this to
date.
Sandra

FDA Makes No Attempt to Hide Industry Ties in Its Review of Baby-
Bottle Safety
Posted May 28, 2008 | 02:57 PM (EST)



It's no surprise that the Bush administration relies heavily on
industry for its policy making.

Most of that advice is kept rigorously secret. The pattern was set
in the earliest days of the administration, when Cheney began
meeting behind closed doors with oil and gas companies to draft the
administration's energy policy. Many details of those meetings
remain secret, despite a vigorous court fight.

But the Food and Drug Administration apparently wasn't told that it
should keep its industry dealings out of sight.

The issue involves the safety of bisphenol A, or BPA, a component of
various plastics, including those used for baby bottles, and the
hard, clear plastics used in Nalgene water bottles and the like. BPA
is also used as a liner in many food and beverage cans to prevent
the food from acquiring a metallic taste.

Many animal studies show that BPA is hazardous and can cause birth
defects. Its effect on humans is unclear as of yet, but the animal
studies raise considerable concern about possible hazardous effects
on humans. We are animals, too.

The Washington-based Environmental Working Group has found that most
of us are continually being exposed to BPA. It cites studies showing
that BPA in bottles and cans seeps into food. And researchers have
found BPA in human breast milk, serum, saliva, and cord blood.

A website run by the American Plastics Council, the plastic-industry
trade group, shrugs off any concern. "Consumer products made with
BPA are safe for their intended uses and pose no known risks to
human health," it says.

Now back to the FDA and its industry ties. In April, the U.S.
government's National Toxicology Program issued a report raising
serious concerns about the harm that BPA could cause to human growth
and development. Two days later, the Canadian government took
various actions to reduce BPA exposure, including restricting its
use in baby bottles and in cans containing infant formula.

Nalgene and Playtex quickly announced a shift to BPA-free products.
Wal-Mart and Toys-R-Us announced they would phase out baby bottles
containing BPA.

And the FDA issued its report on BPA: "We believe," the FDA said,
that "there is a large body of evidence that indicates that FDA-
related products containing BPA currently on the market are safe."

Where did the FDA come up with that conclusion?

In a letter to House Committee Chairman John Dingell (D-Mich.), the
FDA said its conclusion was "based on our most recently completed
reviews of two pivotal multigenerational oral studies."

The first was a study in which BPA was fed to mice. The study, the
FDA said, was "sponsored by the American Plastics Council." It
confirmed that BPA was safe.

The second was a study in which BPA was fed to rats. Sponsored by
the American Plastics Council. In that study, too, BPA got passing
grades.

Two pivotal studies, both sponsored by the plastics industry.

Dingell fired off a response asking why the FDA relied on those two
studies.

"Given that there are dozens of published, peer-reviewed studies
related to BPA, your development of critical public health policy in
this manner, especially as related to infants and children, seems
highly questionable."
It's a reasonable question. And here is another one: If the FDA was
going to rely almost entirely on industry-sponsored studies to come
to its conclusions, why didn't it try to hide that? Why admit it
openly?

Perhaps the FDA was counting on the public and press to pay little
attention. And that, indeed, is largely what happened.


More in Politics...

http://www.huffingtonpost.com/paul-raeburn/fda-makes-no-attempt-to-
h_b_103907.html

Non-profit fronts for Drug Industry (Breast cancer support group)


The Boston Globe reports that "little attention has been paid to
smaller nonprofits, especially patient groups that are largely
funded by the drug industry." Much as doctors are on the take, a lot
of so-called patient "advocacy" groups are pimping for the drug and
medical device industry.

The Globe describes one such industry front group, the Breast Cancer
Resource Committee, founded by Elzora K. Brown, a former staff
assistant to former US House Majority Leader Jim Wright. Brown
regularly testifies at public FDA advisory hearings, "packing an
emotional punch as advisers vote on controversial drug and device
approvals."

These paid lobbying efforts on behalf of industry are carried out
under the pretext of advocacy in the public interest.

The Globe reports: From 1996 to 2004 , the years for which Internal
Revenue Service records are available, the Breast Cancer Resource
Committee raised about $3.4 million from mostly corporate donors,
including hundreds of thousands of dollars from such drug firms as
Amgen Inc. Pharmaceuticals LP , GlaxoSmithKline PLC, and Pfizer Inc.

"As her nonprofit's coffers swelled, Brown's salary jumped from
$40,100 to $162,500 --roughly one-third of every dollar raised.
During that time, the group paid up to $2,600 a month for a four-
story Washington, D.C., townhouse, assessed at $788,510 , where
Brown lived and worked."

The stakes for drug companies are high. Breast cancer remedies
generate $35 billion in sales per year. And African-Americans are a
particularly deep market for any drug maker to court. Elzora Brown
is African-American.
A Mother Jones expose focused on the National Alliance for Mental
Illness (NAMI) which began cashing in on the industry
promotion "patient advocacy" charade early on. In 1999 Mother Jones
reported that 18 drug firms gave NAMI a total of $11.72 million
between 1996 and mid-1999. These include Janssen ($2.08 million),
Novartis ($1.87 million), Pfizer ($1.3 million), Abbott Laboratories
($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), and
Bristol-Myers Squibb ($613,505). See: [Link]

NAMI's leading donor is Eli Lilly and Company, maker of Prozac,
which gave $2.87 million during that period. In 1999 alone, Lilly
will have delivered $1.1 million in quarterly installments. "In the
case of Lilly, at least, "funding" takes more than one form. Jerry
Radke, a Lilly executive, is "on loan" to NAMI, working out of the
organization's headquarters.

Mother Jones reported that (then executive director of NAMI)
Laurie "Flynn explains the cozy-seeming arrangement by
saying, "[Lilly] pays his salary, but he does not report to them,
and he is not involved in meetings we have with [them]." She
characterizes Radke's role at NAMI as "strategic planning."

Of note, Flynn now heads TeenScreen, a controversial scheme that
falsely labels teen agers as mentally ill. TeenScreen is promoted as
a suicide prevention tool without any evidence to back up that
claim. In fact, TeenScreen is designed to increase the psychotropic
drug market--the only certain beneficiaries are NAMI's industry
benefactors: Eli Lilly; Janssen; Pfizer; Novartis; Abbott; Weyth-
Ayrs; Bristol-Mayers Squibb; GlaxoSmithKline

See also Health Care Renewal for a report on the Elzora Brown case.


[Link]The Boston Globe
Drug firms' funding of advocates often escapes government scrutiny
Many patient groups depend on it, raising tricky ethical questions
By Diedtra Henderson March 18, 2007

WASHINGTON -- Elzora K. Brown could stand before a microphone and
calmly describe the swath of devastation that cancer has cut through
five generations of her family. Her great-grandmother, grandmother,
mother, three sisters, and three nieces had breast cancer . And, at
age 31 , Brown was diagnosed with the same kind of cancer.

"My own story is replicated in the lives of high-risk families
across the globe," Brown told an audience of Food and Drug
Administration advisers considering a controversial application to
allow wider sales of silicon gel breast implants, " families who
every single day quietly and patiently confront the ravages of
breast cancer with far more courage and fortitude than I could ever
muster and with far fewer resources than I have at my own disposal."

Brown's message about the need to reduce disproportionately high
mortality rates among African-American women, like herself,
resonated whether she was testifying before the FDA, addressing the
nation's mayors, or speaking with members of Congress, where she was
a staff assistant to former US House Majority Leader Jim Wright.

What few in Brown's audiences knew is that the patient advocate
personally profited from her cancer-survival message, accepting
funding from major pharmaceutical companies that produce cancer
treatments, according to tax records.

Brown, 57 , wears a wig to conceal graying hair slowly growing back
after she successfully fended off a second cancer; last June she
underwent her final chemotherapy treatment for ovarian cancer.
Through speaking engagements for the Breast Cancer Resource
Committee, a patient-advocacy group Brown founded in 1989 , she
highlighted the benefits of early cancer screening, offered a
support group for African-American women, and called attention to
the need for diversity among participants in clinical trials for new
treatments. The efforts earned her dozens of awards, including one
from the Washington, D.C., mayor for community service, and a
presidential appointment to the National Cancer Advisory Board .

Patient advocates like Brown regularly testify at FDA public
hearings, packing an emotional punch as advisers vote on
controversial drug and device approvals.

Congress has homed in on examples of excessive compensation to
managers of some nonprofits that underwrite what Senator Charles E.
Grassley , Republican of Iowa , has derided as "champagne
lifestyles." And others have targeted conflicts of interest that
taint medical research and creep into FDA advisory panels. But
little attention has been paid to smaller nonprofits, especially
patient groups that are largely funded by the drug industry.

Public Citizen's Peter Lurie , who testifies frequently before FDA
panels, noticed a shift as public hearings "were becoming
contaminated by people who didn't represent the public in any way.
They represented particular moneyed interests." Lurie, deputy
director of the consumer advocacy organization's health research
group, said, "It's a fair question: Who represents patients and how
they come to call themselves" patient representatives?

In 221 advisory committee meetings scrutinized, 32 of 44 speakers
representing patients said they had received funding from a company
that would be affected by the FDA's decision, according to a recent
journal article that Lurie co authored about conflicts of interest
on FDA advisory panels.

While the FDA scours its advisers' backgrounds for such information,
the agency does not require disclosures when patients testify.

Nor do drug makers highlight such ties. "As a survivor, I want a
healthy life after breast cancer, so the long-term side effects of
treatment must figure into the treatment decision," Brown said in a
press release touting Ellence , a breast cancer drug that showed
lower heart risk. The release, distributed by Pfizer Inc., did not
disclose the funding that Brown's group received that year from the
drug giant.

Six-figure salary >From 1996 to 2004 , the years for which Internal
Revenue Service records are available, the Breast Cancer Resource
Committee raised about $3.4 million from mostly corporate donors,
including hundreds of thousands of dollars from such drug firms as
Amgen Inc. Pharmaceuticals LP , GlaxoSmithKline PLC, and Pfizer Inc.
As her nonprofit's coffers swelled, Brown's salary jumped from
$40,100 to $162,500 --roughly one-third of every dollar raised.
During that time, the group paid up to $2,600 a month for a four-
story Washington, D.C., townhouse, assessed at $788,510 , where
Brown lived and worked. She also made liberal use of the committee's
American Express card for "incidental, personal expenses," according
to tax records, leaving the balance unpaid.

The nonprofit's accountant, James Dunn , of White Hall, Md .,
declined to respond to questions about liens the IRS filed against
Brown in 2003 , which allege she underpaid taxes by $179,257 from
1997 to 2002 .

An IRS spokesman said the agency cannot discuss the specifics of an
individual's tax lien, but no records have been filed indicating the
IRS has discharged the liens. In a brief telephone conversation this
week , Brown declined to comment except to say she has paid the tax
liens and has spent the funds she raised properly.

Last July, in a lengthy interview, she said questions about her
finances arose because of testimony she gave in support of breast
implants. Her comments to federal advisers raised the ire of
a "nasty, contentious group of women" who disagreed with her views,
Brown said. She has declined requests to clarify her IRS reports,
sent by fax and overnight mail.

A Boston consultant who works exclusively with nonprofits, however,
said Brown's salary and her use of the Breast Cancer Resource
Committee's funds to pay her lease warrant scrutiny.

"In a vacuum, Elzora Brown's salary is, arguably, not outrageous,"
said Thomas A. McLaughlin , a consultant at Grant Thornton LLP and
author of "Streetsmart Financial Basics for Nonprofit Managers ,"
which coaches nonprofit leaders on how to read and use financial
data. "What is far less defensible is the fact that she is paid
nearly one-third of every dollar that comes through the door."

Brown's highest salary was in 2002 , when she was paid $162,500 and
the organization raised $554,993 . Brown's salary would have ranked
her among the highest-paid chief executives for nonprofit advocacy
groups of that size, according to a 2005 compensation survey of
1,660 nonprofits. It compares with a median salary of $72,000 paid
to chief executives of nonprofit advocacy organizations with annual
revenue from $500,000 to $1 million , according to Abbott, Langer &
Associates Inc. , a firm that conducts salary surveys.

In 2002 , Brown also was reimbursed $37,246 for expenses and tallied
$2,682 in personal charges on the committee's American Express card,
according to the IRS filing. By 2004 , that unpaid card balance was
$4,414 .

"It's looking like this is her own piggy bank," said Daniel
Borochoff , president of the American Institute of Philanthropy , a
charity watchdog based in Chicago . "You need to separate business
and personal expenses; that's a pretty common principle."

Combined with her benefits and the pay she awarded her niece -- who
was the committee's lone paid employee that year -- the $264,746 in
spending in 2002 amounted to 47 percent of the Breast Cancer
Resource Committee's total revenue.

By contrast, the National Organization for Rare Disorders ,
generously funded by such biotechnology companies as Biogen Idec
Inc. , had total revenue of $7.6 million in 2004 . Its president,
Abbey S. Meyers , was paid $129,943 . The salary and benefits paid
to Meyers and the organization's four highest-paid employees
accounted for about 5.2 percent of the group's spending.

`Wild West atmosphere' By working out of an office in her basement,
Brown nestled into a regulatory black hole: Unlike attorneys general
in other states, the attorney general's office in Washington, D.C.,
has lacked authority to investigate nonprofits, although it will
gain such power within three months. Also, Brown's budget was too
small to attract the attention of other regulators.

"It's a Wild West atmosphere," Borochoff, of the American Institute
of Philanthropy , said of the oversight of small nonprofits in
Washington. "Basically, a group this size can get away with a lot."

Despite what nonprofit experts describe as questionable spending,
Brown's corporate backers defend their funding decisions.
AstraZeneca, which paid Brown's group at least $380,047 from 1999 to
2004 , said it remains a "proud" partner with the Breast Cancer
Resource Committee.

The committee "provides a valuable resource through its dedication
to reducing the incidence and mortality of breast cancer among
African-American women, particularly those who have little or no
access to adequate healthcare and treatment," Kirsten Evraire, a
spokeswoman for AstraZeneca cancer therapies, said in a statement.

The stakes for drug companies are high. Breast cancer remedies
generate $35 billion in sales per year. And African-Americans are a
particularly deep market for any drug maker to court.

African-Americans suffer disproportionately higher rates of chronic
ailments, such as diabetes , with blacks nearly twice as likely as
whites to have that disease. Black men are nearly seven times as
likely as white men to be diagnosed with HIV , according to the
Centers for Disease Control and Prevention . And, when it comes to
cancer , African-Americans have the highest mortality rate of any
racial or ethnic group, according to the American Cancer Society ,
lowering life expectancy when compared with whites.

In return for their donations to patients' groups, drug companies
are able attach their names to causes that cancer patients are
passionate about, said Selma Schimmel , a three-time cancer survivor
who heads a nonprofit that produces a weekly radio show for cancer
patients.

The nonprofits consider pharmaceutical and biotechnology industry
donations essential.

"When a company donates to us in support of a program that gives aid
directly to patients, it is a humanitarian gift, not a donation to
influence us," said Meyers , president of the National Organization
for Rare Disorders. "If companies stop supporting these programs, we
will not be able to help patients who could not otherwise afford
their treatments."

Brown said the Breast Cancer Resource Committee has been on hiatus
since she moved to Oklahoma to be near her ailing mother.

But during its heyday, the committee's actions were typical of a
nonprofit -- mainly aimed at spreading the message as widely as
possible. For instance, in 2001 , the group co produced a one-hour
television special funded by the Susan G. Komen Breast Cancer
Foundation , the world's largest grassroots network of breast cancer
survivors, highlighting innovative ways to reach African-American
women, including sending mammography vans to churches and
dispatching health workers to beauty salons.

Dangerous Devices
Matthew Herper and Robert Langreth 11.27.06

Twenty million Americans walk around with high-tech medical gear
grinding away inside them. Are they safe?

Johnson & Johnson's drug-coated stent is a miracle of medical
engineering. The tiny, stainless-steel mesh tube, less than 4
millimeters wide, relieves the crushing chest pain that occurs when
the heart is starved of blood. Covered in a chemical that keeps the
artery from closing, the stent slides into a blocked vessel in a
simple, not very invasive procedure and stays there, propping it
open. After it hit the market in April 2003, cardiologists implanted
the new stent in 350,000 people in eleven months, though it costs
nearly three times as much as older, noncoated versions.

Since then drug-coated stents from J&J and Boston Scientific have
been inserted into the arteries of 4 million people. The
breakthrough medical devices generate $5 billion a year in sales
from a million patients. You might figure that, being federally
regulated, these devices were approved only after the manufacturers
established both their safety and their efficacy. But that's true
only up to a point. It turns out that the teensy tubular scaffolds
have never been shown to prevent heart attacks or save lives; their
human trials were smaller, of shorter duration and more narrowly
focused than trials for many new drugs; and half of all applications
involve "off-label" uses, deploying stents in ways that weren't
studied at all in clinical testing.

Now new data indicate that the stents, because of their supposedly
miraculous coating, may cause 4,500 heart attacks every year, up to
2,000 of them fatal. This increased risk, moreover, could persist
for a lifetime, requiring patients to take blood thinners for the
rest of their lives, thereby facing the sometimes fatal side effects
of those drugs.

"There's so much evidence" of the new danger, says Spencer King, the
Piedmont Hospital cardiologist who in 1987 implanted the first stent
in North America. He says up to 30% of patients who get drug-coated
stents would fare better with bare metal, avoiding extra heart
attack risk; some probably didn't need a stent procedure at
all. "Everybody agrees this is real," he says.

But Johnson & Johnson insists it sees no significantly increased
risk. Boston Scientific says the worries are overblown. It and many
researchers say the drug-coated stents' ability to vastly reduce
reclogging outweighs the risks. Next month the two gadget giants
will have to defend their thriving business before an expert panel
advising the Food & Drug Administration on the issue. Whatever the
outcome, can plaintiff lawyers be far behind?

The flap over stents is the latest in a series of safety scares now
racking the booming, $80 billion-a-year business of medical devices.
Some 20 million Americans now walk around embedded with high-tech
gear: artificial hips and knee joints, pacemakers, heart
defibrillators and more. Most of the 80,000 gadgets in use--and most
of the 4,000 new ones okayed every year--are safe and effective.

But 79 devices have been yanked off the market in the past five
years because of potentially fatal side effects, up 65% over the
previous five years; 2,300 more gadgets have been recalled for
lesser complications. And when a recall happens, often the suspect
device remains inside patients.

Implantable defibrillators, which deliver a shock to the heart to
prevent it from shutting down, have been surgically implanted into
hundreds of thousands of patients in recent years. Then in 2005
defib maker Guidant told doctors about a design flaw that could
render two of its models ineffective--three years after it first
spotted the problem. Some of the 40,000 patients with these models
underwent surgery to replace them, while others wait for what might
go wrong. The manufacturer, now owned by Boston Scientific, faces
550 individual or class suits. Cardiologists say that the number of
malfunctions is small compared with the number of lives saved.

Guidant also took a hit in 2003 over its Ancure aortic stent.
Approved in 1999 after trials involving 621 patients, it was created
to thwart aortic aneurism, a weak spot in the main artery from the
heart. (If the aneurism bursts, the patient could die.) Guidant soon
learned the delivery system sometimes got stuck in blood vessels
during installation. But instead of reporting all of the problems to
the FDA, as required, the company initially kept it quiet. In two
years the new stent went into some 7,600 patients--and malfunctions
occurred in more than 2,600 of the cases, leading to 12 patient
deaths, the Justice Department says. After seven whistleblowers
alerted the feds, Guidant pleaded guilty to ten felonies, paid a $92
million fine and shut down the business making the aortic stent.

Now some doctors are flagging the potential dangers of new
implantable gadgets to treat back pain, prevent stroke and soothe
severe heartburn. Some doctors decry J&J's new metal disc, known as
the Charite, which has been implanted in the spines of several
thousand patients. It was approved by regulators after a trial
involving only 304 patients--and only 36% of them fared well enough
to get off narcotic painkillers.

Neck stents made by Abbott Laboratories are coming into question,
too. They can prevent strokes by propping open the carotid artery,
letting patients avoid the usual practice of having that vessel cut
open in surgery. But in October a 527-patient study sponsored by the
French government found that 10% of patients who got neck stents
died or had a stroke in the following month--double the complication
rate for surgery. Abbott says its studies show no added risk, and
one supporter, German cardiologist Klaus Mathias, says the French
study was the most poorly run clinical trial he had ever seen.
Abbott is conducting trials in 4,000 patients to settle the matter.

Another much-debated fix: tiny clumps of polymer lodged in the
esophagus to quell heartburn. Boston Scientific's Enteryx spurts a
polymer into the throat to alleviate pain. It was approved in 2003
after being tested in FDA trials in a mere 109 patients over 12
months. (By comparison, 11,000 patients took Wyeth's ulcer pill,
Protonix, for the same amount of time in order to get the drug
approved.)

But the plastic-dispensing device was difficult to use properly.
Sometimes doctors delivered the polymer to the wrong place, causing
internal bleeding and kidney damage. One patient bled to death when
the chemical was injected into the aorta instead of the esophagus.
The company voluntarily pulled the device in 2005.

Several competing heartburn gadgets remain on the market, despite
limited testing. "These things were rushed to market too early,
without being tested enough," contends gastroenterologist Walter
Hogan at the Medical College of Wisconsin, who calls for a
moratorium on their use until better studies are done.

More safety questions may arise with increasing frequency. Hundreds
of clinical trials are under way for still more miracle gadgets: new
devices to treat depression by using magnetic fields applied to the
skull; replacement parts for bad heart valves; a mesh bag that is
wrapped around the heart to help counteract heart failure.




---------------------------------------------------------------------
-----------

Some doctors, academics and patient advocates blame the lapses on a
medical-industrial complex made up of acquiescent regulators, gadget-
happy cardiologists and surgeons who rake in consulting and
appearance fees from device makers, and pushy device makers
themselves. These critics cite an overly lax regulatory process,
trials that are far less demanding than those for drugs and a lack
of follow-up after treatment.

Some devices "haven't been as safe as they should be," says David
Waters, a cardiologist at the University of California, San
Francisco. "It's just easier for something that doesn't work well to
slip by." Charles Rosen, a spinal surgeon and safety crusader at UC,
Irvine, adds: "The FDA isn't meeting its responsibility to ensure
the safety and efficacy of devices for the American public.
[Regulators] are manipulated by industry." Says Eric Sacks of
Emergency Care Research Institute, a nonprofit that tracks recall
data: "The system is overwhelmed."

The FDA admits as much, acknowledging "inadequacies"
and "shortcomings" in tracking device safety and vowing to overhaul
its approach. "I don't see this as a bad thing--I see it as good,"
says James Tobin, chief of Boston Scientific, of efforts to more
thoroughly test devices. The device industry trade group, AdvaMed,
says the FDA "does a good job" and that makers are helping
it "streamline and refine postmarket reporting mechanisms."

That is an elusive quest, given the swelling ranks of gadget
patients. Each year half a million people in the U.S. undergo spinal-
fusion surgery, says research firm Frost & Sullivan. They get cages,
screws and rods implanted in the spine, despite studies that show
fusion is not very effective for lower back pain. A total of 160,000
Americans get artificial hips made of titanium and plastic; 280,000
get knee replacements; a quarter-million get defibs. Only one
implantable-defibrillator patient in five ends up needing a jolt to
the heart. To be sure, you don't know in advance which patients will
need this life-saving jolt.

This thriving trade in man-made body parts has enriched shareholders
of device makers: An index of 11 such stocks is up 43% in four
years, while a drugmaker index has fallen 2%, hurt by the Vioxx
safety scandal and other travails. The gadget craze has created
several fortunes, making billionaires of William Cook of Cook Group,
who used a blowtorch to make an early catheter, and John Abele,
cofounder of Boston Scientific.

The device boom also has fattened the wallets of thousands of
physicians. The advent of angioplasty created a new breed: the
interventional cardiologist--14,000 of them. Elsewhere 3,500 doctors
specialize in implanting parts for aching backs.

The symbiosis between docs and device makers concerns some
experts. "Physicians like to do things that work, that make money
and promote their specialty," says Frank Veith, a vascular surgeon
at New York University Medical Center who is critical of newfangled
neck stents.

The industry's ties to docs are so cozy that at a recent conference
on "Trans-catheter Cardiovascular Therapeutics," in Washington,
D.C., the hosts put out a booklet disclosing conflicts of interest.
It ran on for 45 pages. Many researchers disclosed having accepted
thousands of dollars in research grants and consulting and speaker
fees. The organizer, cardiologist Gregg Stone of Columbia
University, revealed that 12 companies had each paid him $10,000 or
more and that he had taken equity stakes in 11 more. Stone says
working with industry leads to advances that help patients.

UC, Irvine's Charles Rosen argues that scores of spine
surgeons "have basically become marketing men for these companies
and earn huge consulting fees."

"It is a rigged system," Rosen laments. He has formed the
Association of Ethical Spine Surgeons for physicians who are free of
such conflicts; 50 have signed up.

Now the feds are stepping in. Medtronic in July agreed to pay $40
million in fines to settle civil allegations that its spinal-devices
unit paid kickbacks to doctors in the form of sham consulting
agreements, shady royalty pacts and lavish trips; though the company
paid up, it denies any wrongdoing.

Some patients feel betrayed. Catherine Rich, 40, of Mission Viejo,
Calif., endured debilitating back pain for three months before
following her surgeon's advice to let him embed her spine with an
$11,500 disc from J&J. "It was presented like it was going to solve
all my problems. I was going to be this bionic woman," she says. But
her agony returned, worse than ever--she couldn't go to work, care
for her 4-year-old son or have sex with her husband.

So Rich had to undergo a second surgery, this one performed by Dr.
Rosen. He argues that J&J's Charite disc increased her pain, but he
left it in place and fused together two vertebrae. Rich says she
still can't climb stairs easily and spends 23 hours a day in a
special hospital bed. "It ruined my life." So far she hasn't sued--
but at least 30 other disc recipients have.

Rosen believes hundreds more patients have been hurt by the new
disc, which has been implanted in several thousand people. (He has
done some limited work reviewing cases for plaintiff lawyers.) Rosen
contends J&J's trial compared Charite with an outmoded surgery to
make the metal disc look more effective.

J&J denies the trial was rigged and insists the Charite disc has a
low complication rate and that it lets patients recover faster than
when they undergo older fusion surgery; only 8% of 688 patients it
studied needed repeat operations. Texas Back Institute spine surgeon
Richard Guyer concurs, citing results in more than 300 patients at
his clinic. The vast majority "are very happy," says Guyer, who
receives consulting fees from J&J.

Making myriad metal parts for ailing spines now is a $2.3 billion-a-
year business, Frost & Sullivan says, growing 25% a year. The number
of lumbar fusions, to name one procedure, tripled from 1990 to 2001,
reaching 120,000 that year. "Most spine devices are of uncertain
efficacy and probably add to the complication rate," says internist
Richard Deyo at the University of Washington. He studied spinal-
fusion surgeries in Washington State and found that as procedures
soared from 1990 to 2000, the rate of repeat surgeries rose a bit;
it would have fallen had the devices worked well.

But critics who assert there is no data supporting back surgery
are "flat-out wrong," says spine surgeon John Peloza of
Dallas. "Surgery is expanding because the technology is so much
better." He adds that no progress would be made if device makers and
doctors didn't work closely together. Spine device maker Medtronic
says back surgery "has proven results."

The booming industry's humble beginnings go back a century. In 1886
J&J opened up shop in New Brunswick, N.J. on the fourth floor of a
former wallpaper factory; 14 employees made sterile surgical
dressings. In the late 1950s and early 1960s came the first
artificial hips, developed by British surgeons, and then the first
artificial heart valves. The first pacemaker that could be implanted
in patients came about the same time, from a then tiny firm called
Medtronic.

The modern device era exploded in 1977 with the invention of
angioplasty, when German cardiologist Andreas Gruentzig made a tiny
slice near the hip of a patient and inserted a catheter tipped with
a balloon into an artery. He snaked it up into the heart, inflating
the balloon to squish a clump of plaque against the artery's inner
wall to clear it.

The new procedure led to the founding of Boston Scientific in 1979.
Around the same time the implantable defibrillator was invented,
building Medtronic and St. Jude Medical. Angioplasty, defibs and
orthopedics are now mainstays of the device industry.

The industry was barely regulated until 1976, when Congress
empowered the FDA to ensure devices were safe, effective and well
made. But the new law included a loophole called 510(k) that remains
today: A device can be approved with few or no clinical trials if it
is deemed "substantially equivalent" to a gadget that existed before
1976.

Most of the thousands of devices in use today were cleared under
this easy passage, even frightfully intrusive new tools. In 2004
Concentric Medical of Mountain View, Calif. unveiled one of the
first devices to treat stroke, a kind of corkscrew for the brain. It
is fed from a slit in the groin into the neck to clear out the
vessel and then is removed. It was approved via 510(k) because it
was similar to older devices.

But some neurologists say it has not yet been proved to help
patients recover from stroke, even as stroke drugs with better data
were turned down. "It is very frustrating. Approving this device has
made it difficult to find out how well it works," says University of
Pittsburgh neurologist Lawrence R. Wechsler. Concentric counters
that it now is running a federally funded trial of 120 patients.

Another device, the Aquadex FlexFlow from CHF Solutions of Brooklyn
Park, Minn., is used as an alternative to drugs to drain excess
fluid from patients with congestive heart failure. The Aquadex sits
outside the body like an intravenous bag, cycling healthy blood back
into the patient. It cleared the FDA on a 510(k) exception in 2002.
By contrast, a J&J drug to treat the same problem endured 14
clinical trials covering more than 1,500 patients--and still drew
fire for safety questions. CHF has new results from a 200-patient
study that seem to show the FlexFlow, which costs $14,500, has some
advantage over drugs--four years after it went on the market.

The FDA looked at tightening device rules in the early 1990s, but
Congress undercut the effort. To be sure, it is possible for
regulators to go too far in regulating implants. In 1992 the agency
called a moratorium on silicone breast implants, playing into the
hands of tort lawyers making an industry of suing silicone implant
maker Dow Corning. After the company was bankrupted by the
litigation it became apparent that there was scarcely any
scientifically established link between silicone and the health
problems blamed on it. Dow Corning is now out of bankruptcy. Breast
implants may return to the market by next year.

In 1993 a high-ranking FDA official, Robert Temple, issued a report
on how the burgeoning device industry could conduct more rigorous
clinical trials. That faded in 1997 when Congress passed a law
dictating that new devices must be approved by the "least
burdensome" method possible.

By that time the industry had gotten a big boost with the first
metal stent for clogged arteries. Doctors were doing 300,000 balloon
angioplasties annually in the U.S., but in upward of 40% of cases
the artery reclogged (a process known as restenosis). To combat
this, J&J in 1994 introduced the first stent to prop the artery
open; this cut restenosis to 15% of cases. Angioplasties soared to
800,000 a year by 2002. Then came J&J's drug-coated stent, which
reduced the reclogging problem to fewer than 5% of patients, and
angios increased to more than a million a year.

The new stent, the Cypher, was tested on 1,058 patients in its
biggest trial; a heart-drug study might require three times as many
subjects. The tiny tube was coated in a rubbery polymer that
released bits of medicine over time, preventing the artery from
growing scar tissue over the device and reclogging the blood flow.
But that left the polymer and metal exposed, and in rare cases blood
clots form on this foreign surface and cause heart attacks.

Patients with drug-coated stents get clots at the rate of 1 per 500
patients per year, to judge from outside analyses of the company's
trial results. J&J and Boston Scientific will be running trials of
tens of thousands of patients to better understand the blood-clot
risk, but results won't be available for years.

Many doctors argue that the FDA should toughen its standards for
introducing new implants of all kinds. But doing so might slow
innovation in a breakthrough-fueled industry. "The device industry
would grind to a halt" if studies for implants became as big as
those for drugs, says Mitchell Krucoff of the Duke Clinical Research
Institute. Thomas Fogarty, a professor at Stanford who has patents
on 63 devices, says young doctors are reluctant to invent new
devices because of the regulatory scrutiny they already face. "We in
the U.S. are slowing down and losing our position of leadership," he
frets.

Daniel Schultz, the FDA's chief device regulator, says new medical
devices don't need the large-scale exhaustive trials of the drug
industry because it is easier to predict the behavior of a machine
than it is to track the chemical interactions of a new drug in the
body. But he vows to pursue sweeping changes in how the FDA monitors
device performance after approval, creating a massive database to
track all "adverse events" far faster than today's paperwork
reporting process can.

"We are talking about fundamental changes," Schultz says. He
emphasizes that the benefits of medical devices "far outweigh any
risk." The hard part: sifting out the few flawed devices that emerge
in this surging business of bionic parts--and stopping them from
posing hidden threats to millions of patients.
http://www.ethicalspinesurgeon.com/articles/forbes.htm

HPV Vaccine Blamed for Teen's Paralysis


A month after 13 year old Jenny Tetlock was vaccinated against the
HPV virus, she missed the lowest hurdle in gym class. It was the
first sign of a degenerative muscle disease that 15 months later
left her nearly completely paralyzed.

Her father, Philip Tetlock, a professor at UC-Berkeley, has embarked
on an odyssey to find out whether the vaccine, Gardasil, is to blame.

Tetlock is not the only one concerned. The public watchdog group
Judicial Watch has been periodically obtaining adverse event reports
on Gardasil from the FDA. 10 deaths have been linked to Gardasil
since September 2007, and there have been 140 reports so far this
year of serious side effects such as miscarriage and Guillain-Barré
syndrome.

Sources:
http://articles.mercola.com/sites/articles/archive/2008/08/02/hpv-
vaccine-blamed-for-teen-s-paralysis.aspx?source=nl




I have posted this as alot of people implant women think this
vaccine is good in my opinion it is no safer than implants are and
for any parent to allow there child to be vaccinated is ludicrous.

Dr. Mercola's Comments:
Once you educate yourself and know the facts about Gardasil, the
truth about HPV, and the statistics of cervical cancer, it will
become quite clear just how outrageously useless -- and dangerous --
this vaccine really is.

The FDA, in not-so-rare form, insists there's no medical reason to
be worried about the side effects of Gardasil. "We're monitoring the
safety of the HPV vaccine very carefully, and the only adverse event
that causes some concern is fainting after the vaccine," says Robert
Ball, director of the FDA's office of biostatistics and division of
epidemiology.

He continues to say, "Higher rates of Guillain-Barré have been
associated with the swine flu vaccine and possibly with the
meningitis vaccine Menactra, but it is no more common in those who
get Gardasil than in those who don't."

Alright. Let's say you agree with the idea that the cases of
Guillain-Barre syndrome are pure coincidence, despite the fact that
they occur within days or weeks of vaccination.

But what about the deaths?

Infant deaths following Merck's rotavirus are routinely disguised
under the label SIDS (sudden infant death syndrome). So what do we
have when healthy teenagers drop dead for no reason? SAD -- Sudden
Adolescent Death? Will that be the next big thing? Will there be SAD
campaigns, with physicians educating the public about proper
sleeping positions until you're well into your 20's?

Let's get real.

I recently read a comment online from one mother who said she'd do
anything in her power to make sure her children were protected, and
she couldn't understand "the narrow-minded opinions" and "fear
mongering" of Gardasil nay-sayers.

  "Would you rather your daughters died of cervical cancer?" she
wrote.

Well, that's just it, right there! As I will show you, the chances
of your daughter dying of cervical cancer are already VERY LOW, and
the possibility of Gardasil sparing them from cervical cancer is so
RIDICULOUSLY LOW that no reasonable person could argue for the use
of this HPV vaccine if they knew all the facts.

How Likely are You to Develop and Die From Cervical Cancer?

According to the CDC, cervical cancer used to be the leading cause
of cancer death for women in the United States. However, in the past
40 years, the number of cervical cancer cases and the number of
deaths thereof have decreased significantly. It is believed that
this decline is the result of many women getting regular Pap tests,
which can find cervical pre-cancer before it turns into cancer.

According to the U.S. Cancer Statistics: 2004 Incidence and
Mortality report, 11,892 women in the U.S. were told that they had
cervical cancer in 2004, and 3,850 women died from the disease. The
American Cancer Society mirrors these statistics, estimating that
about 3,870 women will die from cervical cancer in the U.S. in 2008.

Well. We've already lost 18 girls, some as young as 12, in the
effort to spare them from the mere possibility of cervical cancer
later in life.  Others have developed debilitating and potentially
life-threatening ailments within weeks of being vaccinated, and
others still have had spontaneous abortions or given birth to babies
with birth defects.

Also consider this: Cervical cancer usually develops in your late
20s to mid 30s. The protection period of Gardasil is estimated to be
5 years. That means, if you receive your first set of shots when
you're 10 years old, you'd need at least 2 to 4 additional booster
shots to make it through your 30s. And THAT means you'll have to
expose yourself to the potential side effects of Gardasil over and
over and over again.

But now to the real clincher, and I want you to read the following
section as many times as you need to let this truly sink in…

U.S. statistics show there are 30 to 40 cervical cancer cases per
year per one million women between the ages of 9 and 26, which is
the age bracket that Gardasil targets (and was tested on).

According to Merck, Gardasil was shown to reduce pre-cancers by
12.2% to 16.5% in the general population. So, instead of ending up
with 30 to 40 cases of cancer per million, per year, in that age
bracket, the HPV vaccine can potentially bring it down to 26 to 35
cases of cervical cancer.

What that means is that you would have to vaccinate one million
girls to prevent cervical cancer in 4 to 5 girls.

Further, about 37 percent of women who develop cervical cancer
actually die from the disease, so vaccinating ONE MILLION girls
would prevent 1 to 2 DEATHS per year, at the bargain-basement price
of $360 million per year, plus potentially lifelong suffering for an
untold number of women, which has no price tag.

Is this REASONABLE?

Understanding the HPV – Cancer Connection

There are more than 100 types of human papillomaviruses (HPVs). Of
them, about 40 types of HPV affect your genitals or sex organs, and
can cause genital warts, for example.  10-30 strains can lead to
cervical cancer. The remainder can cause to skin infections and
common warts on your hands and feet.

The CDC web site states that certain types of HPV can infect your
cervix and lead to cervical cancer over many years. (This may be one
of the reasons why cancer rates keep dropping, because there's
sufficient amount of time to treat any abnormalities if you're
getting regular Pap smears.)

It also says that in 90 percent of women infected, HPV clears up on
its own within two years, at which point your cervical cells go back
to normal. It is only when the HPV virus lingers for many years that
these abnormal cells could turn into cancer.

Additionally, it's important to know that the vast majority of
abnormal Pap tests do NOT equate to cancer. Even abnormal Pap tests
showing pre-cancerous cells of the CIN II grade clear by themselves
without treatment 40 percent of the time.

And, current treatment of pre-cancers has limited the progression to
actual cancer to only 1 percent. So, just like the polio vaccine,
Merck's HPV vaccine is coming out at a time when cervical cancer is
already on a steady decline, and anyone who starts talking about how
Gardasil has reduced cervical cancer rates in the next few years is
likely talking absolute nonsense.

Informed Consent: Understand the Numerous Dangers of the HPV Vaccine

First of all, the Gardasil vaccine contains just four types of HPV
out of the more than 100 strains. So if you contract one of the 96+
types that aren't included, you're out of luck. And, if you've
already been exposed to one of the four types of virus in the
vaccine, it doesn't work against those either.

This means that even if you accept the risks and get vaccinated,
your chances of getting some form of HPV are still very high.
Whether or not the HPV virus will lead to genital warts or cervical
cancer, however, depends in large part on the state of your immune
system.

Gardasil, on the other hand, can damage your immune system, and can
potentially lead to death. The main causes of death include blood
clots, acute respiratory failure, cardiac arrest, and "sudden death"
due to "unknown causes" shortly after receiving the vaccine. Again,
11 of the reported deaths occurred within 2 weeks of vaccination,
and 7 within 2 days, so whatever the mechanism that induces death,
it's quick and efficient.

Other side effects include:

Miscarriages and spontaneous abortion
Genital wart outbreak, even in patients who had tested negative for
HPV and genital warts prior to vaccination
Facial warts and warts on hands and feet
Anaphylactic shock
Loss of consciousness
Grand mal seizures
Coma
Paralysis
Says Tom Fitton, President of Judicial Watch, "Given all the
questions about Gardasil, the best public health policy would be to
reevaluate its safety and to prohibit its distribution to minors. In
the least, governments should rethink any efforts to mandate or
promote this vaccine for children."

It's also important to know that Merck has NOT evaluated Gardasil's
potential carcinogenity or genotoxicity.

There is currently no way of knowing how the HPV vaccine affects
fertility, birth defects, cancer, if it can pass through breast
milk, or if it can alter your genes or the genes of your future
children (genotoxicity).

However, five subjects who got the vaccine around the time of
conception had babies with birth defects, whereas no birth defects
occurred among the subjects who received a placebo. Likewise,
earlier last year when there were "only" 1,637 adverse reports, 18
of 42 women who had received the vaccine while pregnant experienced
side effects ranging from spontaneous abortion to fetal
abnormalities.

Also remember that you cannot sue Merck if your child dies after
receiving the vaccine.

Drug companies have cleverly manipulated the government so that they
are immune from prosecution. Instead they've made the U.S. taxpayers
foot the bill for the hundreds of millions of dollars that are paid
out to families of children who are harmed or killed every year from
vaccines.

And even though it is nearly impossible to get one of these
payments, more than $1.5 billion has been paid out to affected
families already. So ponder on these stats if you haven't already
taken a firm position on the vaccine issue.

Good Example of How to Fake a Safety Study

In yet another less-than-ethical twist, Merck was permitted to use
an aluminum-containing placebo instead of a standard saline placebo.
Since Gardasil contains 225 mcg of aluminum, using an aluminum-
containing placebo may paint an entirely inaccurate picture of its
level of safety, since you're apt to get similar, detrimental side
effects in the placebo group.

In fact, about 60 percent of those who received either Gardasil or
the aluminum placebo had systemic adverse events including:

Headache
Fever
Nausea
Dizziness
Vomiting
Diarrhea,
Myalgia (muscle pain)
Gardasil recipients had more serious adverse events such as
gastroenteritis, appendicitis, pelvic inflammatory disease, asthma,
bronchospasm and arthritis.

You should also know that aside from being injected with four types
of HPV proteins, girls and women who receive this vaccine also
receive the following adjuvants:

1. Aluminum adjuvants, which have been linked to neurological damage
including multiple sclerosis, Alzheimer's disease, and Parkinson's
disease

2. Polysorbate 80, which has been linked to infertility in mice.

3. Sodium borate, a main ingredient in roach killer.

How To Reduce Your Risk of Cervical Cancer to Virtually Zero

The following have been shown to be associated with increased risk
of cervical cancer:

Nutritional deficiencies, especially vitamin A and folate
Mineral deficiency (zinc, selenium, calcium and iron)
Smoking
Birth control use
Douching
It is believed that smoking has more to do with the progression of
an HPV infection to cervical cancer than any other single factor, as
smokers with HPV go on to develop cervical cancer much more
frequently than infected non-smokers.

Cervical cancer is also well documented to be caused by an infection
acquired through sexual contact. So in addition to avoiding smoking
and eating a nutritious diet, it is behaviorally avoidable.

According to a New England Journal of Medicine study, the use of
condoms reduces the incidence of HPV by 70 percent, offering FAR
better protection than Gardasil's protection rate of 12.2 to 16.5
percent.

As I've already mentioned, in 90 percent of all cases, your immune
system is strong enough to clear up an HPV infection without ANY
treatment. So maintaining a strong immune system is vital to beat
HPV as well as any other infection or disease.


http://articles.mercola.com/sites/articles/archive/2008/08/02/hpv-
vaccine-blamed-for-teen-s-paralysis.aspx?source=nl

Ehanks Karen

United States Court of Appeals

For the First Circuit




---------------------------------------------------------------------
-----------




No. 07-2626



NEW JERSEY CARPENTERS PENSION & ANNUITY FUNDS; FOLKSAM ASSET
MANAGEMENT; THIRD MILLENNIUM TRADING LLP; DEERFIELD BEACH NON-
UNIFORMED MUNICIPAL EMPLOYEES RETIREMENT PLAN; PLUMBERS AND
PIPEFITTERS LOCAL NO. 520 PENSION FUND; HORATIO CAPITAL LLC,



Plaintiffs, Appellants,



CHARLES BROWN, Individually and on Behalf of All Others

Similarly Situated; ROCHELLE LOBEL; BIOGEN INSTITUTIONAL

INVESTOR GROUP; LONDON PENSIONS FUND AUTHORITY; NATIONAL

ELEVATOR INDUSTRY PENSION FUND; CARY GRILL, Individually and

on Behalf of All Others Similarly Situated,



Plaintiffs,



v.



BIOGEN IDEC INC.; WILLIAM RASTETTER; JAMES MULLEN; BURT ADELMAN;
THOMAS BUCKNUM; PETER N. KELLOGG; WILLIAM ROHN,



Defendants, Appellees.


United States Court of Appeals

For the First Circuit




---------------------------------------------------------------------
-----------




No. 07-2626



NEW JERSEY CARPENTERS PENSION & ANNUITY FUNDS; FOLKSAM ASSET
MANAGEMENT; THIRD MILLENNIUM TRADING LLP; DEERFIELD BEACH NON-
UNIFORMED MUNICIPAL EMPLOYEES RETIREMENT PLAN; PLUMBERS AND
PIPEFITTERS LOCAL NO. 520 PENSION FUND; HORATIO CAPITAL LLC,



Plaintiffs, Appellants,



CHARLES BROWN, Individually and on Behalf of All Others

Similarly Situated; ROCHELLE LOBEL; BIOGEN INSTITUTIONAL

INVESTOR GROUP; LONDON PENSIONS FUND AUTHORITY; NATIONAL

ELEVATOR INDUSTRY PENSION FUND; CARY GRILL, Individually and

on Behalf of All Others Similarly Situated,



Plaintiffs,



v.



BIOGEN IDEC INC.; WILLIAM RASTETTER; JAMES MULLEN; BURT ADELMAN;
THOMAS BUCKNUM; PETER N. KELLOGG; WILLIAM ROHN,



Defendants, Appellees.



---------------------------------------------------------------------
-----------



ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSACHUSETTS



[Hon. William G. Young, U.S. District Judge]



---------------------------------------------------------------------
-----------



Before



  Lynch, Chief Judge,

Torruella, Circuit Judge,

Stafford,

                    Of the Northern District of Florida, sitting
bydesignation.


Close District Judge.




---------------------------------------------------------------------
-----------



     Vincent R. Cappucci with whom Stephen D. Oestreich, Robert N.
Cappucci, Shannon L. Hopkins, Entwistle & Cappucci LLP, Sanford P.
Dumain, Richard H. Weiss, Milberg Weiss LLP, Nancy Freeman Gans, and
Moulton & Gans, PC were on brief for appellants.

     James R. Carroll with whom Matthew J. Matule, Michael S. Hines,
and Skadden, Arps, Slate, Meagher & Flom LLP were on brief for
Biogen Idec Inc., William Rastetter, James Mullen, Burt Adelman,
Peter N. Kellogg, and William Rohn.

     Mark A. Berthiaume with whom Timothy E. Maguire and Greenberg
Traurig LLP were on brief for Thomas Bucknum.






August 7, 2008















          LYNCH, Chief Judge. In this securities case, a drug
company, Biogen Idec Inc., conducted clinical trials and received
accelerated FDA approval for TYSABRI, a promising new drug for
multiple sclerosis and similar autoimmune diseases. The price of the
company stock increased as FDA approval was sought and granted. Less
than three months after the approval, on February 18, 2005,
continuing clinical trials of the drug revealed that two patients
had contracted a type of infection perhaps associated with the drug.
One of those patients had died. Within ten days, on February 28,
2005, the company, after consultation with the FDA, voluntarily
withdrew the drug from the market. The share price precipitously
dropped.

          This federal securities class action soon followed,
alleging the company and senior executives had intentionally
misrepresented the safety of and the market for the drug by omission
and commission. The district court dismissed the complaint for
failing to meet adequately the pleading requirements for scienter
established in the Private Securities Litigation Reform Act of 1995
("PSLRA"), Pub. L. No. 104-67, 109 Stat. 737. We affirm.

I.

          On March 2, 2005, a subset of the plaintiffs in this action
brought suit in federal district court against Biogen Idec Inc. and
company executives.

                    The individual named defendants all were
seniorexecutives at Biogen. Specifically, at all times relevant to
thecomplaint, William Rastetter was Biogen's Executive Chairman and
aDirector. James Mullen was Biogen's Chief Executive Officer
andPresident. Peter Kellogg was Biogen's Executive Vice President
ofFinance and Chief Financial Officer. William Rohn was
Biogen'sChief Operating Officer. Burt Adelman was Biogen's Executive
VicePresident of Development. Thomas Bucknum was Biogen's
ExecutiveVice President and General Counsel from November 2003 until
heresigned on March 9, 2005.


Close For convenience, we refer to all defendants collectively
as "Biogen," except where any are specifically differentiated. The
plaintiffs sued on behalf of a putative class of individuals and
entities who purchased Biogen stock between February 18, 2004 and
February 28, 2005, the class period. Other duplicate class actions
followed, with complaints filed on March 10, 2005 and April 10,
2005. The actions were consolidated and a consolidated amended
complaint was filed October 13, 2006.

          We accept well-pled factual allegations in the complaint as
true and draw all inferences in the plaintiffs' favor. Miss. Pub.
Empl. Ret. Sys. v. Boston Scientific Corp. (Boston Scientific), 523
F.3d 75, 85 (1st Cir. 2008); see also Tellabs, Inc. v. Makor Issues
& Rights, Ltd., ___ U.S. ___, 127 S. Ct. 2499, 2509 (2007); ACA Fin.
Guar. Corp. v. Advest, Inc., 512 F.3d 46, 52 (1st Cir. 2008). We
also consider the undisputed public documents utilized by each side
in this case and considered by the district court. See Boston
Scientific, 523 F.3d at 86.

A.       TYSABRI and Its Effects

          TYSABRI

                    In earlier phases, TYSABRI was known by the name
Antegrenor by its generic name, natalizumab.


Close is a drug developed, manufactured, and marketed by Biogen for
the purpose of treating autoimmune diseases, especially multiple
sclerosis ("MS"), Crohn's disease, and rheumatoid arthritis.
                    MS is described in more detail in the text.
Crohn'sdisease is a "subacute chronic [inflammation of the
intestine] ofunknown cause, . . . characterized by patchy deep
ulcers that maycause fistulas, and narrowing and thickening of the
bowel byfibrosis and lymphocytic infiltration [infiltration of white
bloodcells]." Stedman's Medical Dictionary 575 (26th ed. 1995)
(entryon "enteritis, regional enteritis").

                    Rheumatoid arthritis is "a systemic disease,
occuringmore often in women, which affects connective tissue; . . .
accompanied by thickening of articular soft tissue . . . ; thecourse
is variable but often is chronic and progressive leading
todeformities and disability." Id. at 149 (entry
on "arthritis,rheumatoid arthritis").


Close Generally, autoimmune diseases cause the human body's immune
system to attack otherwise healthy tissues in the body. TYSABRI
works, in part, by preventing migration of white blood cells
throughout the body.

          In MS, for example, the arrival of white blood cells to the
central nervous system causes inflammation, which in turn destroys
nerve fiber and the fatty tissue surrounding nerve fiber, creating
lesions or plaques in the nervous system. Over time, these plaques
disrupt the function of the nervous system, causing the various
symptoms of MS, including progressive physical disability and
eventual cognitive impairment. TYSABRI prevents the white blood
cells from migrating to the central nervous system, relieving the
inflammation and mitigating the symptoms of MS.

          Another effect of TYSABRI's mechanism of action is that the
drug could prevent white blood cells from migrating to places in the
body where they are needed. This may leave a patient vulnerable
to "opportunistic infections," which occur when ordinarily benign
organisms infect individuals with impaired immune systems. While a
healthy immune system would prevent these organisms from causing
illness, an impaired immune system may not be able to stave off
infection.

          One such opportunistic infection is progressive multifocal
leukoencephalopathy ("PML"), a usually fatal disease of the central
nervous system caused by the "JC virus." The JC virus is latent in
the kidneys of almost all adults, and invades the brain and causes
PML only when the immune system is severely impaired.

B.       TYSABRI's Path to Market and the FDA Approval Process

          The Food and Drug Administration ("FDA") requires any drug
to go through a series of clinical trials before it can be approved
for marketing and sales in the United States. See generally L.
Sukhatme, Note, Deterring Fraud: Mandatory Disclosure and the FDA
Drug Approval Process, 82 N.Y.U. L. Rev. 1210, 1219-20 (2007)
(describing the FDA's drug approval process). After a drug is
initially tested on animals, the developer of the drug submits an
application to the FDA for approval to test the drug on humans. Id.;
see also 21 C.F.R. § 312.20. If this request is approved, human
testing begins, and typically follows three phases, commonly known
as clinical trials. See 21 C.F.R. § 312.21. Each phase requires the
company to test the drug on a broader population and results in more
stringent monitoring and evaluation. Id.

          Phase I studies generally involve twenty to eighty
subjects, and are designed to determine how the drug works in humans
and the side effects associated with increasing doses. Id. § 312.21
(a)(1). Phase II studies usually involve no more than several
hundred subjects, and are designed to evaluate the effectiveness of
the drug, as well as common short-term side effects and risks. Id. §
312.21(b). Phase III studies are large-scale trials, usually
involving several hundred to several thousand subjects, and are
intended to gather the information necessary to provide an adequate
basis for labeling the drug. Id. § 312.21(c). Throughout the
clinical trials, the drug company must report to the FDA and to all
participating physicians any serious and unexpected adverse drug
experiences that occur. Id. § 312.32(c)(1)(i)(A). After Phase III,
the FDA considers the results of all of the clinical trials in
determining whether to approve a drug for market. See id. §§ 314.125
(b), 314.126(a).

          If a proposed drug "address[es] [an] unmet medical need"
for a "serious or life-threatening condition," like TYSABRI does,
the FDA provides an expedited approval process. 21 U.S.C. § 356(a)
(1); see also Consolidated Am. Compl. ("CAC") ¶¶ 83-85. Through this
process, which has a target for FDA action of six months, the drug
maker interacts with the FDA during drug development and the FDA can
begin reviewing portions of the drug application before the full
application is completed. See U.S. Food and Drug Administration,
Center for Drug Evaluation and Research, FDA's Drug Review and
Approval Times, available at
http://www.fda.gov/cder/reports/reviewtimes/default.htm. The FDA can
approve drugs treating life-threatening illnesses that are
significant advancements over existing treatments on the basis of
preliminary evidence prior to formal demonstration of patient
benefit.

                    In an effort to strengthen FDA regulation of
drugsalready approved and on the market when problems arise,
Congressenacted the Food and Drug Administration Amendments Act of
2007,Pub. L. No. 110-85, 121 Stat. 823, which provides the FDA
withenhanced authority regarding the postmarket safety of drugs,
seeid. §§ 901-21. The events in this case pre-date the statute.


Close See 21 C.F.R. §§ 314.500, 314.510.

          In August 2000, Biogen and another company, Elan Pharma
International Limited ("Elan"), announced that they had entered into
a joint collaboration agreement to bring TYSABRI to market. The
agreement required the two companies to share equally in the
revenues and costs and set up a number of joint teams, so that both
companies played a role in both the development of TYSABRI,
including clinical trials, and the marketing of TYSABRI. The
agreement also required that any information, including adverse
events, discovered by one company be reported to the other in a
timely manner.

          Both the pre-clinical animal trials and the first phase of
clinical trials of TYSABRI as a treatment for MS had been completed
in the 1990s by Elan's corporate predecessor. After the
collaboration agreement, it was decided that Biogen would lead the
clinical trials for MS and Elan would lead the clinical trials for
Crohn's disease.

          By September 2001, preliminary Phase II MS results had
begun yielding promising data. Biogen then began Phase III of MS
testing in December 2001 with two trials. The first trial, named
AFFIRM, sought to test whether TYSABRI was effective in slowing the
rate of disability in MS patients. The second, SENTINEL, sought to
evaluate the safety and efficacy of TYSABRI in combination with
another MS drug produced by Biogen, AVONEX.

          The Phase III clinical trials for Crohn's disease began in
December 2001 and consisted of two trials: ENACT-1 (designed to
evaluate clinical responses to TYSABRI and its ability to induce
remission of Crohn's disease) and ENACT-2 (designed to evaluate the
duration and effects of TYSABRI). In July 2003, Biogen announced
that it could not act on the results of ENACT-1 because of a "larger
than expected placebo response rate." On January 29, 2004, Biogen
announced that the ENACT-2 trial had met its primary endpoint, and
that because the ENACT-1 trial had been unsuccessful, Biogen was
beginning an additional Phase III trial, ENCORE, which was designed
to evaluate the safety and efficacy of TYSABRI in patients with
moderate to severe Crohn's disease. Altogether, approximately 3,900
patients received TYSABRI in the three phases of the MS and Crohn's
disease clinical trials.

          On February 18, 2004, Biogen announced its intention to
apply to the FDA for expedited approval for TYSABRI as a treatment
for MS, based on data from one year of its two Phase III MS trials,
AFFIRM and SENTINEL. Over the next two days, the price of Biogen
stock increased from $44.26 to $58.98, an increase of 33.3%, and was
traded at a daily volume of between six-and-a-half and nine times
greater than the average daily trading volume during the class
period. On May 25, 2004, Biogen announced that it had submitted its
application to the FDA.

          The FDA then conducted a detailed analysis of the safety
and efficacy data available for TYSABRI, focusing on the data for
the MS clinical trials but also considering any serious safety
events that occurred in the Crohn's trials. For the ongoing Phase
III trials, which provided the "primary evidence of safety and
efficacy," the FDA's review considered "data through cut-off dates
ranging from March 1st to April 30th, 2004."

          On November 23, 2004, Biogen announced that the FDA had
granted accelerated approval of TYSABRI and the drug was available
for sale. The following day, the stock price rose from $57.43 to
$58.59, an increase of 2.0%.

          The FDA placed no limitations on TYSABRI's use in
combination with other drugs. The package insert label included with
the drug noted only that "TYSABRI® is indicated for the treatment of
patients with relapsing forms of multiple sclerosis." However, the
package insert label did contain the following statement relevant to
the plaintiffs' claim: "The safety and efficacy of TYSABRI in
combination with other immunosuppressive agents have not been
evaluated."

C.       Withdrawal of TYSABRI from the Market

          At approximately noon on February 18, 2005, roughly three
months after TYSABRI was granted FDA approval, Biogen senior
officers attended a meeting where they learned that two patients
taking TYSABRI in the clinical trials had contracted PML, one of
whom had died.

          Ten days later, on February 28, 2005, Biogen and Elan
suspended all clinical trials and withdrew TYSABRI from the market.

                    At this point, according to plaintiffs, Phase III
of theAFFIRM MS trial was completed and Phase III of the SENTINEL
MStrial was substantially completed; two of the Phase III
Crohn'sdisease trials were completed and an additional Phase III
Crohn'sdisease trial was in progress; and the Phase II
rheumatoidarthritis trials had been underway for approximately eight
months.


Close In a press release, Biogen announced to the public that two
patients had contracted PML, one of the two had died, and the
decision to withdraw TYSABRI was made "in consultation with [the]
U.S. Food and Drug Administration (FDA)."
                    A withdrawal of a drug from the market is not the
same asa voluntary recall. "Market withdrawal means a firm's removal
orcorrection of a distributed product which involves a
minorviolation that would not be subject to legal action by the Food
andDrug Administration or which involves no violation." 21 C.F.R.§
7.3(j). A recall is "a firm's removal or correction of amarketed
product that the [FDA] considers to be in violation of thelaws it
administers and against which the agency would initiatelegal
action." Id. § 7.3(g).


Close On March 30, 2005, Biogen announced that a patient in the
Crohn's disease trial who died in 2003 had been misdiagnosed with
brain cancer, and in fact had died from PML.
                    According to the complaint, this announcement
occurred onMarch 1, 2005, the day after the withdrawal. CAC ¶ 7. A
pressrelease included in the record announcing the additional
PMLdiagnosis, the authenticity of which is not disputed, is
datedMarch 30, 2005. Joint App'x at 309.


Close

          The stock market reacted strongly to the withdrawal of the
drug from the market. On February 28, Biogen's stock price dropped
from $67.28 to $38.65, a 42.5% drop. Some 118 million shares were
traded, more than thirty times the average daily trading volume
during the class period.

D.       Insider Trading Allegations

          Plaintiffs allege that during the class period the
individual insider defendants sold significant amounts of Biogen
stock while they knew that the share price was artificially inflated
because of the alleged misrepresentations concerning TYSABRI. The
class period ran from February 18, 2004, the day Biogen announced it
was seeking expedited FDA approval of TYSABRI, to February 28, 2005,
the day that TYSABRI was withdrawn from the market. The alleged
insider sales during the class period are as follows.

                    Each individual defendant made multiple sales
ondifferent dates in the class period. To avoid the cumbersomenessof
listing each date and each corresponding amount, we describeeach
individual defendant's sales in aggregate.


Close

          Defendant Rastetter, Biogen's Executive Chairman, sold
582,045 shares, approximately 78% of his shares as of February 18,
2004, the beginning of the class period, for total proceeds of
approximately $35 million. Defendant Mullen, the Chief Executive
Officer and President, sold 192,000 shares for total proceeds of
approximately $12 million, which constituted virtually all of the
shares he held as of February 18, 2004. Defendant Adelman, the
Executive Vice President of Development, sold 80,870 shares,
virtually all of the shares he held at the beginning of the class
period, for total proceeds of approximately $5 million. Defendant
Rohn, the Chief Operating Officer, sold 350,000 shares,
approximately 91% of the shares he held at the beginning of the
class period, for total proceeds of approximately $20 million. Rohn
announced his retirement on November 29, 2004, twelve days after his
final alleged insider sale, and retired on January 31, 2005.
Defendant Bucknum, the General Counsel, sold 188,600 shares,
virtually all of the shares he held at the beginning of the class
period, for total proceeds of approximately $12 million.

          All but one of the alleged insider sales occurred before,
often well before, February 18, 2005, the date of the meeting where
plaintiffs allege that defendants first learned of the safety issues
with TYSABRI. The only alleged insider trading between February 18,
2005 and the February 28, 2005 withdrawal (the end of the class
period) is by defendant Bucknum, the General Counsel. On February
18, 2005, the same day as the meeting, Bucknum sold 89,700 shares
for total proceeds of approximately $6 million, which constituted
approximately half of all the shares he held at the beginning of the
class period. The SEC filed a civil complaint against Bucknum on
January 12, 2006 for his February 18 trade. He settled the action,
paying $3 million in disgorgement and agreeing not to serve as an
officer or director of a public company for five years. Bucknum
resigned from Biogen on March 9, 2005.

E.       FDA Investigation and TYSABRI's Return to Market

          On March 7 and 8, 2006, the FDA's Peripheral and Central
Nervous System Drugs Advisory Committee ("Advisory Committee") held
public hearings to evaluate the potential reintroduction of TYSABRI.
In these hearings, Biogen and the FDA shared results of further
testing and analysis, and various members of the public, including
physicians and patients, gave comments.

          On June 5, 2006, the FDA approved TYSABRI's reintroduction
into the market. The FDA's approval restricted TYSABRI to use as a
monotherapy for relapsing forms of MS; it was not approved for use
in combination with other drugs or for other diseases. Because of
the potential risk of PML, TYSABRI was recommended only for those MS
patients who do not respond to other MS treatment. Every MS patient
using TYSABRI must enroll in a risk management program run by Biogen
which closely monitors patients for any signs of PML. In addition,
the package insert label includes a "black-box" warning, the
strictest warning the FDA can require, which warns of the risk of
PML.  See 21 C.F.R. § 201.57(c)(1); see also CAC ¶ 17. In addition,
the package insert label contains the following statement: "The
safety and efficacy of TYSABRI in combination with other
antineoplastic, immunosuppressant, or immunomodulating agents have
not been established."

                    The FDA in 2008 approved TYSABRI to
treat "moderate-to-severe Crohn's disease in patients with evidence
of inflammationwho have had an inadequate response to, or are unable
to tolerate,conventional Crohn's disease therapies." Press Release,
U.S. Foodand Drug Administration, FDA News: FDA Approves Tysabri To
TreatModerate-to-Severe Crohn's Disease (Jan. 14, 2008), available
athttp://www.fda.gov/bbs/topics/NEWS/2008/NEW01775.html. TYSABRI
forCrohn's disease entails substantially the same warnings
andlimitations as TYSABRI for MS, and Crohn's patients must
alsoenroll in the risk management program. Id.

                    On July 31, 2008, Biogen announced that two more
patientshad contracted PML. See Todd Wallack, Despite Risks, Many
Stayingwith Tysabri, Boston Globe, Aug. 2, 2008, at A7. The share
priceof Biogen dropped approximately 28% on the news. Id. at A8.


Close

II.

          Two days after the withdrawal of TYSABRI from the market
following the PML diagnoses of clinical trial participants, the
first group of plaintiffs brought suit against Biogen and the
individual defendants.

          The consolidated amended complaint alleges that during the
class period, the defendants made material misstatements, including
material omissions of fact concerning the safety and marketability
of TYSABRI, and that this had caused the market price of Biogen to
be artificially inflated, both harming investors and allowing
individual insider defendants to enrich themselves in excess of $137
million. The amended complaint alleges that the acts and omissions
of all of the defendants but Bucknum violated sections 10(b) and 20
(a) of the Securities Exchange Act of 1934, 15 U.S.C. §§ 78j(b) and
78t(a), and Rule 10b-5, 17 C.F.R. § 240.10b-5, and that all of the
defendants (including Bucknum) violated section 20A of the
Securities Exchange Act of 1934, 15 U.S.C. § 78t-1.

          In particular, the plaintiffs' amended complaint advances a
theory of material misstatements about the safety of the drug and a
related theory about material overstatements of the market for the
drug and growth in the company's sales. The amended complaint
alleges that during the class period, defendants made numerous
unqualified statements trumpeting TYSABRI's safety and efficacy and
its consequent significant positive financial impact on Biogen's
profitability. When these statements were made, defendants failed to
disclose in a timely manner their knowledge of at least two safety
risks: that patients taking TYSABRI had developed opportunistic
infections (including infections other than PML) and, in some cases,
had died; and that the announced safety and efficacy of using
TYSABRI in combination with other MS drugs had never been
established. Given defendants' knowledge of these facts and the
substantial risks posed by TYSABRI, plaintiffs allege, the
defendants misrepresented the market for TYSABRI in their positive
financial forecasts. These misrepresentations and omissions, in
turn, harmed plaintiffs in their purchase and sale of securities.

          In November 2006, all the defendants except Bucknum filed a
motion to dismiss. Bucknum filed a separate motion to dismiss in
January 2007. In September 2007, after oral argument, the district
court dismissed all claims against all defendants. In October 2007,
the district court explained its reasoning in a separate memorandum,
which was unreported. In dismissing the section 10(b) and the Rule
10b-5 claims, the court found that while the plaintiffs had alleged
material misrepresentations and omissions with the appropriate
specificity, they had not pled facts giving rise to a strong
inference of scienter. The court then dismissed the section 20(a)
and 20A claims because the court had found no predicate securities
violation.



III.

A.       Pleading Requirements

          On a Rule 12(b)(6) motion, we examine de novo whether a
complaint meets the PSLRA's requirements and we "accept well-pled
factual allegations in the complaint as true and make all reasonable
inferences in plaintiff's favor." Boston Scientific, 523 F.3d at 85.
The complaint must allege "a plausible entitlement to relief" in
order to survive a motion to dismiss. Id. (quoting Bell Atl. Corp.
v. Twombly, 127 S. Ct. 1955, 1967 (2007)) (internal quotation marks
omitted). Here, the court also properly considered certain public
documents put into the record by both plaintiffs and defendants. See
id. at 86 (citing Watterson v. Page, 987 F.2d 1, 3 (1st Cir. 1993)).

          The PSLRA requirements are familiar: the plaintiffs'
complaint must plead adequately (1) a material

                    Information is material if a reasonable investor
wouldhave viewed it as "having significantly altered the 'total mix'
ofinformation made available." Basic, Inc. v. Levinson, 485 U.S.224,
232 (1988) (quoting TSC Indus. v. Northway, Inc., 426 U.S.438, 449
(1976)) (internal quotation marks omitted); accord BostonScientific,
523 F.3d at 85; Gross v. Summa Four, Inc., 93 F.3d 987,992 (1st Cir.
1996). Further, "[w]hile a company need not revealevery piece of
information that affects anything said before, itmust disclose
facts, 'if any, that are needed so that what wasrevealed [before]
would not be so incomplete as to mislead.'" In reCabletron Sys.,
Inc., 311 F.3d 11, 36 (1st Cir. 2002) (quotingBackman v. Polaroid
Corp., 910 F.2d 10, 16 (1st Cir. 1990) (enbanc)).


Close misrepresentation or omission; (2) scienter; (3) a connection
with the purchase or sale of a security; (4) reliance; (5) economic
loss; and (6) loss causation. Id. at 85; ACA Fin., 512 F.3d at 58.

          The PSLRA requires that when alleging that a defendant made
a material misrepresentation or omission, a complaint must "specify
each statement alleged to have been misleading [and] the reason or
reasons why the statement is misleading." 15 U.S.C. § 78u-4(b)(1).
If the allegation is "made on information and belief," then the
complaint must "state with particularity all facts on which that
belief is formed." Id.

          We will assume arguendo, consistent with the district
court's opinion, that plaintiffs' amended complaint satisfied the
first element, that is, that plaintiffs pled material
misrepresentations or omissions in a sufficiently detailed manner as
to "time, place and content." Aldridge v. A.T. Cross Corp., 284 F.3d
72, 78 (1st Cir. 2002).

          We turn to the question of the adequacy of the complaint's
pleading scienter. We discuss materiality only insofar as it is
relevant to the pleading of omissions said to be relevant to
scienter.

          Scienter is a "mental state embracing intent to deceive,
manipulate, or defraud." Ernst & Ernst v. Hochfelder, 425 U.S. 185,
193 n.12 (1976). The plaintiff must establish that "defendants
consciously intended to defraud, or that they acted with a high
degree of recklessness." Aldridge, 284 F.3d at 82. The PSLRA
requires that the plaintiffs' complaint, "with respect to each act
or omission . . . , state with particularity facts giving rise to a
strong inference that the defendant acted with the required state of
mind." 15 U.S.C. § 78u-4(b)(2).

          Congress did not define what qualifies as a "strong
inference" in the PSLRA, but in Tellabs, the Supreme Court held that
in order to be "strong," an "inference of scienter must be more than
merely plausible or reasonable -- it must be cogent and at least as
compelling as any opposing inference of nonfraudulent intent."
Tellabs, 127 S. Ct. at 2504-05.

                    The district court misspoke when it said the
SupremeCourt's decision in Tellabs had "largely conform[ed] to
thepreexisting standard in this circuit," Dist. Ct. Mem. at 11,
inadopting as adequate to show a "strong inference" of scienter
thestandard of whether "a reasonable person would deem the
inferenceof scienter cogent and at least as compelling as any
opposinginference one could draw from the facts alleged." Tellabs,
123 S.Ct. at 2510. In fact, Tellabs overruled our decision in In
reCredit Suisse First Boston Corp., 431 F.3d 36, 49 (1st Cir.
2005),as we recognized in ACA Financial, 512 F.3d at 59. The lapse
is ofno consequence; the district court articulated the correct
legalstandard for scienter. Whether it correctly applied that
standardis what is at issue in this appeal.


Close

          Scienter must be examined by looking at the complaint as a
whole. See Boston Scientific, 523 F.3d at 86; ACA Fin., 512 F.3d at
59. A court must weigh "not only inferences urged by the
plaintiff . . . but also competing inferences rationally drawn from
the facts alleged." Boston Scientific, 523 F.3d at 86 (quoting
Tellabs, 127 S. Ct. at 2504) (internal quotation marks omitted). "[W]
here there are equally strong inferences for and against scienter,
Tellabs now awards the draw to the plaintiff." ACA Fin., 512 F.3d at
59 (citing Tellabs, 127 S. Ct. at 2510).

          Of particular import to this case is another proposition. A
statement cannot be intentionally misleading if the defendant did
not have sufficient information at the relevant time to form an
evaluation that there was a need to disclose certain information and
to form an intent not to disclose it. See id. at 62 (finding that
statements were not established to be materially misleading where
there was "nothing in the amended complaint to establish that the
defendants were aware of facts, at the time they made their
predictions, that would have made those predictions unreasonable");
see also, e.g., Crowell GST Trust v. Possis Med., Inc., 519 F.3d
778, 783 (8th Cir. 2008); Winer Family Trust v. Queen, 503 F.3d 319,
327-29 (3d Cir. 2007); Higginbotham v. Baxter Int'l Inc., 495 F.3d
753, 757-60 (7th Cir. 2007).

B.       Plaintiffs' Allegations of Misleading Statements

          We describe emblematic examples

                    Only seven of the over eighty statements that
theplaintiffs excerpt in the complaint are included here.
Thesestatements are representative of the others.


Close of the alleged misleading statements and the plaintiffs'
allegations that defendants knew at the time these statements were
misleading.

          (1) A statement in a February 18, 2004 press release
attributed to the defendants that: "In previous clinical trials, the
following adverse events occurred more commonly with natalizumab
when compared to placebo: headache, nausea, abdominal pain,
infection, urinary tract infection, pharyngitis and rash. Serious
adverse events have included infrequent hypersensitivity-like
reactions." CAC ¶¶ 164-165.

          (2) A statement, attributed to defendant Mullen, Biogen's
Chief Executive Officer and President, during a March 2, 2004
conference call with analysts that:

                    We agree with the district court that the
statementsincluding financial projections were based on present
factsrelating to the safety of TYSABRI and so do not fall under
thestatutory safe harbor for forward-looking statements. See
15U.S.C. § 78u-5.

                    In analyzing a forward-looking statement, the
aspect ofthe statement that is based on the present fact must
bedistinguished from the aspect of the statement that is a
futureprojection.  See In re Stone & Webster, Inc., Sec. Litig., 414
F.3d187, 213 (1st Cir. 2005). "The safe harbor, we believe,
isintended to apply only to allegations of falsehood as to
theforward-looking aspects of the statement." Id. Here,
theplaintiffs' allegations of fraud, putting aside their
merit,concern defendants' knowledge of the underlying facts of the
safetyand efficacy of TYSABRI at the time the statements were made.


Close

Now, I want to focus really on the current state of the MS market, I
know a lot of people are beginning to think about that very
carefully after this announcement two weeks ago. In the US, there is
approximately 400 to 450,000 MS patients of which 300 to 350,000 in
the relapsing forms, we consider that the eligible market, that
market is slightly over half penetrated. That's about 180,000
patients in the US are on one of the interferons or Copaxone. There
is more than 50,000 quitters, that number is hard to quantify but we
think that's the right ballpark and there is about 10 to 15,000 new
patients diagnosed annually. And when you think about the EU
marketplace, you can pretty much just double all those numbers
except the penetration is a little bit less. So there is huge, there
is still a huge unmet need out there. [W]e do believe that this
innovative therapy will offer hope to a large number of patients and
the market will grow significantly in the US and Europe.

CAC ¶¶ 178, 180.

          (3) Defendant Adelman, the Executive Vice President of
Development, made the following statement during the same March 2,
2004 conference call:

We know that there are patients who have some degree of disease
activity either as measured by relapse rate and/or MRI while they
are on any of the current therapies, and that's why the clinical
development program for this product includes not only a placebo-
controlled trial as a standalone therapy, but includes study where
we look at the efficacy of Antegren when added to patients already
on interferon who still have some evidence of disease activity. So,
I think it's going to be broadly applicable to the entire population
of patients with MS who are or are not on therapy, who still have
evidence of disease activity.

CAC ¶ 181.

          (4) A statement, attributed to Mullen, in an April 30, 2004
earnings report that: "We've had an excellent start to the year.
Both revenue and earnings results are up strongly. The U.S. filing
of ANTEGREN by mid-year is on track. . . . With access to two large
scale manufacturing facilities on both coasts, the Company is well-
positioned to fulfill ANTEGREN's blockbuster potential." CAC ¶¶ 199,
208.

          (5) A statement, attributed to defendant Rohn, the Chief
Operating Officer, in a July 28, 2004 earnings report that: "We are
convinced of Antegren's blockbuster potential. . . . We believe the
potential MS market over the next few years will grow to roughly $6
billion, up from $3.6 billion today, and we believe Antegren will
not only expand the market but also capture a lion's share of the
market." CAC ¶¶ 234, 235.

          (6) A statement, attributed to Adelman, during a July 28,

2004 conference call with analysts that: "[T]here is no evidence
that Antegren is associated with accelerated disease activation or
relapse as we've seen with other potential targeted therapies to
lymphocyte trafficking and you know, we have a huge safety database
and these issues have not come up in conversation, you know, with
any regulatory authority." CAC ¶¶ 237, 238.

          (7) A statement, attributed to Mullen, at a January 11,
2005 healthcare conference that AVONEX was the "ideal combination
product along with Tysabri, it's the only product that has proven
efficacy along side in addition to Tysabri." CAC ¶ 297.

C.       Scienter

          Even if plaintiffs met the standard of showing a material
misrepresentation or omission, as we assume arguendo they did, they
must still allege facts giving rise to a "strong inference" of
scienter. "Knowingly omitting material information is probative,
although not determinative, of scienter." Boston Scientific, 523
F.3d at 87; see also Aldridge, 284 F.3d at 83 ("[T]he fact that the
defendants published statements when they knew facts suggesting the
statements were inaccurate or misleadingly incomplete is classic
evidence of scienter."). The plaintiffs allege that defendants'
knowledge of the misleading nature of the statements, combined with
the individual defendants' insider trading, gives rise to a strong
inference of scienter.

          The situation involved here is paradigmatic of securities
fraud cases against drug development companies where a promising
drug or medical device is approved by the FDA and then later proves
to have health risks which affect the market for the drug. See,
e.g., Oran v. Stafford, 226 F.3d 275 (3d Cir. 2000); In re Carter-
Wallace, Inc. Sec. Litig. (Carter-Wallace I), 150 F.3d 153 (2d Cir.
1998); In re Pfizer Inc. Sec. Litig., No. 04-9866, ___ F. Supp. 2d.
___, 2008 WL 2627131 (S.D.N.Y. July 1, 2008); In re Elan Corp. Sec.
Litig., 543 F. Supp. 2d 187 (S.D.N.Y. 2008); In re Bayer AG Sec.
Litig., No. 03-1546, 2004 WL 2190357 (S.D.N.Y. Sept. 30, 2004);
Anderson v. Abbott Labs., 140 F. Supp. 2d 894 (N.D. Ill. 2001); In
re Abbott Labs. Sec. Litig., 813 F. Supp. 1315 (N.D. Ill. 1992); In
re Pfizer, Inc. Sec. Litig., No. 90-1260, 1990 WL 250287 (S.D.N.Y.
1990).

          Within two days of the withdrawal of TYSABRI from the
market, this securities fraud lawsuit was filed. The theory of the
original complaints was that defendants knew much earlier than
disclosed that TYSABRI would cause PML. That theory appears to have
been abandoned in favor of a theory, in the consolidated amended
complaint, that defendants knew TYSABRI would cause a range of
opportunistic infections other than PML and that TYSABRI used in
combination with other drugs created a substantial safety risk, and
yet they failed to disclose this to the investing public and the
FDA. The key theme of the suit is that Biogen and the defendants
were aware or at least were recklessly unaware of greater safety
risks with TYSABRI for opportunistic infections, particularly in
combination with other MS therapies, than had been announced to the
public, and then intentionally failed to disclose this information
in order to keep share prices high. Plaintiffs' claim is not only
that Biogen misled the investing public, but that Biogen misled the
FDA in order to achieve accelerated FDA approval.

          The reports which companies make to the FDA about drug
trials are not generally made public. See P. Lurie & A. Zieve,
Sometimes the Silence Can Be Like the Thunder: Access to
Pharmaceutical Data at the FDA, Law & Contemp. Probs., Summer 2006,
at 85, 89. And so the investing public has few alternatives to
double-check the accuracy of a drug company's statements to the
public or to the FDA about the safety of an experimental drug. Fraud
on the FDA is, to be sure, prohibited, see 21 U.S.C. § 331, and the
FDA has statutory power to catch, punish, and deter such fraud, see
id. § 372 (FDA empowered to conduct investigations); id. § 332 (FDA
can seek injunctive relief); id. § 333 (FDA can pursue criminal
prosecutions and civil penalties); Buckman Co. v. Plaintiffs' Legal
Comm., 531 U.S. 341, 349-50 (2001). Sometimes FDA data becomes
public much later, as in this case, where both sides use information
from the FDA Advisory Committee hearings on March 7-8, 2006 to
attempt to characterize what was known during the class period.

          By the same token, the investing public is well aware that
drug trials are exactly that: trials to determine the safety and
efficacy of experimental drugs. And so trading in the shares of
companies whose financial fortunes may turn on the outcome of such
experimental drug trials inherently carries more risk than some
other investments. This is true even when the FDA has given fast-
track approval to a new drug.

          Against this background we analyze plaintiffs' various
theories.

          1.   PML Deaths and Other Opportunistic Infections

          Plaintiffs' initial complaints alleged that defendants knew
of PML deaths from the SENTINEL combination therapy trial earlier
than February 18, 2005 and failed to timely disclose the
information. If plaintiffs have not abandoned this claim, it fails
anyway. We agree with the district court that there is no evidence
of record which makes this claim of knowledge before February 18,
2005 a permissible inference.

          Plaintiffs' primary theory advanced on appeal is that the
defendants knew earlier of a series of opportunistic infections from
use of TYSABRI including but not limited to PML, they failed to
adequately disclose these risks, and they announced market
projections they knew to be too optimistic in light of the risk of
all opportunistic infections.

                    These opportunistic infections include
pulmonaryaspergillosis, pneumocystis carinii pneumonia,
cryptosporidialgastroenteritis, Mycobacterium avium intracellular
pneumonia, andBurkholderia cepacia pneumonia.


Close Plaintiffs allege the causal connection between TYSABRI's
market share and a higher risk of all opportunistic infections was
demonstrated by the market's reaction to the withdrawal of the drug
from the market on February 28, 2005 and the limitations placed on
TYSABRI when it was later reintroduced.

          The plaintiffs argue that TYSABRI was withdrawn not only
because of the PML deaths but also because of the other
opportunistic infections. The defendants respond that they meant
what they said when, in the press release announcing the withdrawal
of the drug, they specified that TYSABRI was being voluntarily
withdrawn from the market because of the PML deaths. Again, we agree
with the district court that no plausible inference can be drawn
from the allegations and documents that the reason TYSABRI was
withdrawn was something other than the PML deaths.

          That analysis does not itself end any claim by plaintiffs
of securities fraud. It may still be true that a reduction in the
market for TYSABRI based on the risk of opportunistic infections
other than PML would have an effect on Biogen's share prices. But
even then, defendants cannot have committed fraud if they did not
know at the time that the failure to provide additional information
was misleading. See ACA Fin., 512 F.3d at 62 ("There is nothing in
the amended complaint to establish that the defendants were aware of
facts, at the time they made their predictions, that would have made
those predictions unreasonable . . . ."); Boston Scientific, 523
F.3d at 86 ("Securities actions raise questions of what corporate
managers knew and when they knew it." (emphasis added)).

          Plaintiffs' amended complaint fails to allege facts both
(1) as to when defendants had information about non-PML
opportunistic infections and (2) that the information available
sufficiently suggested a causal relationship between TYSABRI and non-
PML opportunistic infections.

          The plaintiffs rely heavily on the information disclosed in
the initial November 2004 approval of the drug, on the hearings held
by the FDA Advisory Committee on March 7-8, 2006, and on the "black-
box" warning labels the FDA required when TYSABRI was reintroduced
on June 5, 2006 for a more limited market. They also rely on some
other evidence, including confidential source allegations.

          We must take it as true from plaintiffs' allegations that
one of the potential risks of TYSABRI, given its mechanism of
action, was the risk of resulting opportunistic infections. The FDA
said as much in its November 2004 medical review recommending the
drug for accelerated approval. Joint App'x at 448 ("[G]iven the
mechanism of action of natalizumab, this [opportunistic infections]
issue deserves continued scrutiny . . . to more fully characterize
the effect of natalizumab on the immune system."). This risk was one
reason for the continued scrutiny of the drug which did occur,
during the remaining two years of trials and in examining post-
marketing experiences.

          Plaintiffs claim that the FDA gave its approval only
because defendants hid data from it about opportunistic infections.
This is a very serious charge and is not substantiated by the
allegations in the complaint or the documents in the record. The
FDA's accelerated approval was granted in November 2004. Plaintiffs
allege defendants were aware by February 2004 of "all incidents of
death and innumerable opportunistic infections that occurred during
[prior] trials."

                    Plaintiffs claim that this knowledge existed
because thefollowing trials had been completed and their data had
beenunblinded by the following dates: (1) Phase I of the MS trials
by1995; (2) Phase II of the MS trials by September 2001; (3) Phase
IIof the Crohn's trials by May 23, 2001; (4) Phase III of the
Crohn'sENACT-1 study by July 2003; (5) Phase III of the Crohn's
ENACT-2study by January 29, 2004; (6) the first year of Phase III of
theMS trials by February 18, 2004.


Close Pls.' Br. at 10.

          Biogen submitted its application to the FDA on May 25, 2004
and, on June 28, 2004, announced the FDA had designated TYSABRI for
priority review. During the review process the FDA evaluated safety
data primarily from the Phase III MS clinical trials and considered
data from the ongoing Crohn's disease studies. The cut-off dates for
data reviewed ranged from March 1 to April 30, 2004. We thus take
April 30, 2004 as a cut-off date for information that the FDA would
have known. If the FDA were misled, as plaintiffs assert, it was
with respect to pre-April 30, 2004 data. There is no evidence which
permits any inference the defendants intentionally failed to
disclose relevant data to the FDA between April 30, 2004 and when
the FDA gave approval on November 23, 2004, or from the approval
date to the withdrawal of the drug on February 28, 2005.

          The plaintiffs' claim that Biogen hid data from the FDA is
not based on any FDA finding that this was true. Rather, it is based
primarily on plaintiffs' reading of after-the-fact statements about
earlier events made (a) by a Biogen employee at the post-withdrawal
Advisory Committee hearings, (b) by an FDA employee at the same
hearings, and (c) by confidential sources.

          The Biogen employee, Dr. Michael Panzara, presented data at
the hearings from both the MS and the Crohn's disease trials. In
total, 3,900 patients received TYSABRI in both sets of trials. In
the MS trials, a total of three patients developed opportunistic
infections, including the two who developed PML. During the Crohn's
disease trials, five patients were diagnosed as having suffered from
opportunistic infections, including one patient who had been
diagnosed with PML. This results in an incidence rate of 0.2%,
including the PML infections. If the PML were excluded, the
incidence rate would be even lower.

          There is no basis to conclude that these results, excluding
the PML infections, were statistically significant. There is no
plausible inference from the reports of just five patients with non-
PML opportunistic infections that the defendants knew of any causal
relationship between the use of TYSABRI and the separate
opportunistic infections diagnosed for the five patients, and then
intentionally withheld data. "[T]he receipt of an adverse report
does not in and of itself show a causal relationship between [a
drug] and the illness mentioned in the report." In re Carter-
Wallace, Inc. Sec. Litig. (Carter-Wallace II), 220 F.3d 36, 41 (2d
Cir. 2000). "Some adverse events may be expected to occur randomly,
especially with a drug designed to treat people that are already
ill." Id.

          Plaintiffs also cite the testimony of the FDA's Dr. Alice
Hughes at the post-withdrawal Advisory Committee hearings, who
stated that there were seventeen deaths during the clinical trials,
thirteen of which involved patients taking TYSABRI. But plaintiffs
allege that only four of those were a result of an opportunistic
infection (two being PML), and have not pled there was any causal
significance evident from the data. Moreover, there is contrary
evidence. During these same hearings, the FDA's Deputy Director of
Neurology Products, Dr. Marc Walton, stated: "We were not impressed
that the overall mortality rate was markedly different than we might
expect in MS studies." And before the drug was approved, the FDA's
Deputy Director of the Office of Drug Evaluation, Dr. David Ross,
wrote to his superior that the deaths to date in the clinical
studies "d[id] not represent a clear safety signal."

          Further, the plaintiffs also have failed to allege when the
information on the non-fatal opportunistic infections became known.
Many of the infections occurred in the Crohn's disease trials, but
at least three of these trials were ongoing after January 29, 2004,
and so the infections may have occurred or become known after the
relevant time periods.

          Plaintiffs advance the proposition that the fact "that even
one opportunistic infection occurred is significant enough to put
TYSABRI's safety and marketability in question." Pls.' Br. at 30
n.16. In the absence of an allegation or inference of proof of any
statistical significance of the occurrence of one or more non-PML
opportunistic infections, the statement is simply not true and is
also incorrect as a matter of law.

          Indeed, there are no allegations by plaintiffs that
defendants knew of a significant risk of non-PML opportunistic
infections while the FDA was reviewing TYSABRI. No strong inference
can be drawn that defendants knowingly or recklessly withheld
material information from the FDA in order to get fast-track review
and accelerated approval.

          Nor do any statements by FDA officials support such an
inference. Plaintiffs argue that the November 23, 2004 memo from the
FDA's Dr. David Ross, discussed above, which recommended the
approval of TYSABRI, establishes that Biogen withheld data. Dr. Ross
stated: "The events reported do not appear to represent infections
due to opportunistic pathogens . . . ." It is not plausible to read
this as evidence of wrongdoing by Biogen; plaintiffs have not even
presented a viable theory that the statement means that data was
withheld, as opposed to what it says.

                    Plaintiffs also advance a theory that defendants
knew orrecklessly disregarded information that TYSABRI "turn[ed]
off" theimmune system. CAC ¶ 382. At most this is a hypothesis and
wouldhardly support a plausible inference of scienter when the data
fromthe clinical trials do not. The plaintiff overstates a
2004hypothesis by Dr. Lawrence Steinman in a journal article that
thereis "at least a theoretical concern that recipients of the
therapywould become generally compromised in their ability to
fightinfection."


Close

          This leaves only the allegations based on confidential
sources. Our standard for evaluating whether confidential source
material is sufficient under the PSLRA is as follows:

[W]here plaintiffs rely on confidential personal sources but also on
other facts, they need not name their sources as long as the latter
facts provide an adequate basis for believing that the defendants'
statements were false. Moreover, even if personal sources must be
identified, there is no requirement that they be named, provided
they are described in the complaint with sufficient particularity to
support the probability that a person in the position occupied by
the source would possess the information alleged. In both of these
situations, the plaintiffs will have pleaded enough facts to support
their belief, even though some arguably relevant facts have been
left out.



Cabletron, 311 F.3d at 29 (quoting Novak v. Kasaks, 216 F.3d 300,
314 (2d Cir. 2000)) (block quotation). Consequently, we "look at all
of the facts alleged to see if they 'provide an adequate basis for
believing that the defendants' statements were false.'" Id. (quoting
Novak, 216 F.3d at 314). "This involves an evaluation, inter alia,
of the level of detail provided by the confidential sources, the
corroborative nature of the other facts alleged (including from
other sources), the coherence and plausibility of the allegations,
the number of sources, the reliability of the sources, and similar
indicia." Id. at 29-30.

          Defendants argue that Tellabs requires us to revise our law
on confidential sources, but we believe our law on this point is
unchanged. They cite to the Seventh Circuit's decision in
Higginbotham, 495 F.3d at 756 (because of Tellabs, court
must "discount" confidential source allegations). But plaintiffs
overstate their position, even as to Seventh Circuit law. See Makor
Issues & Rights, Ltd. v. Tellabs Inc., 513 F.3d 702, 712 (7th Cir.
2008) (finding confidential source allegations sufficient where they
are "numerous and consist of persons who from the description of
their jobs were in a position to know at first hand the facts to
which they are prepared to testify"); id. ("[T]he absence of proper
names does not invalidate the drawing of a strong inference from
informants' assertions.").

          Tellabs requires that all information in plaintiffs'
complaint be evaluated. 127 S. Ct. at 2509. We think that includes
confidential source information, subject to the restrictions stated
in our case law. We have never said a complaint would survive if it
were based only on confidential source allegations. Indeed, we have
said there must be a hard look at such allegations to evaluate their
worth. See Cabletron, 311 F.3d at 30 ("[C]ourts can competently make
a careful evaluation of securities fraud pleadings based on
anonymous sources, and separate frivolous complaints from those with
potential merit.").

          Scienter involves wrongdoing by high-level company
officials; low-level employees or consultants may well know of the
wrongdoing and wish to disclose it but fear retaliation if their
names appear among the accusers. Legislatures, both federal and
state, have recognized similar fears in enacting anti-retaliation
statutes and in encouraging whistle-blowers. Some allowance at the
motion to dismiss stage for consideration of confidential sources in
litigation is consistent with those policies. See id. ("Employees or
others in possession of important information about corporate
malfeasance may be discouraged from stepping forward if they must be
identified at the earliest stage of a lawsuit."); Novak, 216 F.3d at
314 ("Imposing a general requirement of disclosure of confidential
sources . . . could deter informants from providing critical
information to investigators in meritorious cases or invite
retaliation against them.").

          Before discovery, a confidential source would wish to
remain unnamed, as "a suit might never be brought or if brought
might be settled before any discovery [i]s conducted." Makor Issues
& Rights, 513 F.3d at 711. We decline to adopt a rule which would
exclude confidential source allegations which have every indication
both that the source had access to information and that the
information has the earmarks of credibility, simply because the
identity of the source is not initially revealed.

                    Indeed, Higginbotham presented a different
problem: theidentities of the confidential sources in that case
would neverhave been revealed, 495 F.3d at 757, so the reliance
onconfidential sources in the complaint was apparently solely
adevice by plaintiffs to get past a motion to dismiss and
intodiscovery.


Close And we see no reason to exclude consideration of such
information from the evaluation of whether plaintiffs' strong
inferences of scienter are at least as plausible as defendants'
inferences.

          Here, however, the allegations made by the confidential
sources, even if we assume them to be true, still do not create a
strong inference of scienter.

          Plaintiffs allege that one confidential source, "CS 3," a
neurologist who was involved in the clinical trials for MS,
confirmed the existence of several serious opportunistic infections
during the MS and Crohn's disease trials, and the source
specifically cited one opportunistic infection that occurred during
the MS trials and two from the Crohn's disease trials. CAC ¶ 144.
However, this allegation does not indicate when during the trials
these infections became known. Moreover, the allegation does not
contribute anything additional to plaintiffs' case. Dr. Panzara said
during the FDA hearings that three patients in the MS trials and
five patients in the Crohn's disease trials developed opportunistic
diseases, and Dr. Hughes stated that there were two deaths during
the clinical trials attributable to non-PML opportunistic diseases.
We discussed earlier the shortcomings of these allegations in
establishing the requisite scienter. Nothing is added by the
existence of a confidential source who states that there
were "several" opportunistic infections during the trials and cites
three.

                    Plaintiffs also allege that "in CS 3's opinion,"
many ofthe problems with TYSABRI "were the result of executives at
Biogenbeing excessively aggressive in getting" the drug to the
market. CAC ¶ 146. As with any bald assertion, this gets
plaintiffsnowhere.


Close Similarly, nothing is added by the allegation, even if true,
that another confidential source, "CS 4," was aware of "serious
opportunistic infections" during the Crohn's disease trials. CAC ¶
145.

          Plaintiffs also point to statements by two other
confidential sources. "CS 5," a neurologist involved with the
SENTINEL Phase II trial, stated that five participants in the
Crohn's disease trials developed cancer, as opposed to one patient
in the placebo group, and he was concerned about the types of cancer
the patients had contracted, which included malignant melanoma and
cervical cancer. CAC ¶ 147. Again, there is no indication as to when
during the trials these occurrences became known. Regardless,
assuming it to be true, the allegation that five people developed
cancer in clinical trials involving hundreds of people does not
itself support a plausible inference that defendants knew that
TYSABRI increased the risk of patients developing cancer, let alone
an inference that TYSABRI increased the risk of opportunistic
infections, which are distinct from cancer.

          Finally, "CS 6," a data entry clerk who worked for Biogen
from May to December of 2004, alleged that the number of adverse
events being reported to the company concerning TYSABRI was on
average between fifty and sixty per day; that in June 2004 and just
prior to TYSABRI's approval in November 2004, this volume
was "extremely high, particularly when compared to other clinical
trials" in which this confidential source was involved; and
that "many" of these adverse reports were "serious," such as an
increase in the size of tumors and "complaints suggesting symptoms
of PML." CAC ¶¶ 148-149.

          With the exception of this last assertion, these
allegations say nothing about the nature of the adverse event
reports and therefore, even if true, cannot support an inference
that it was known that TYSABRI causes opportunistic infections. As
for the claim that there were a number of "serious" adverse event
reports, even assuming this to be true, the source provides no
information regarding whether these reports were confirmed, whether
the symptoms being reported were shown to have any connections to
opportunistic infections, or even whether any connections were made
between the symptoms being reported and a patient's use of TYSABRI.

                    At one point in their complaint, when discussing
an FDAadverse event report, plaintiffs appear to count each
reportedadverse event as a new adverse event, even if some of the
reportswere follow-up reports to already-reported adverse events.
See CAC¶ 153. This resulted in higher counts of adverse events,
since oneadverse event involving one patient was counted multiple
times.


Close Again, "the receipt of an adverse report does not in and of
itself show a causal relationship between [a drug] and the illness
mentioned in the report." Carter-Wallace II, 220 F.3d at 41.

          Plaintiffs' claims as to non-PML opportunistic infections
fail to meet the scienter standards of the PSLRA.

          2.   Combination Therapy Claims

          In a related but distinct set of claims, plaintiffs allege
that defendants affirmatively stated that TYSABRI was safe when used
in combination with other drugs when in fact they had no reasonable
basis to believe so. This is different from the allegations that
defendants knew of the risk of opportunistic infections but did not
disclose the risk.

          Plaintiffs point out the two PML diagnoses which led to
withdrawal of the drug occurred during the clinical trials of
TYSABRI in combination with AVONEX, Biogen's other MS drug. And when
the FDA approved the reentry of TYSABRI into the market, the package
insert contained the following warning about the use of TYSABRI with
other MS therapies: "Concurrent use of antineoplastic,
immunosuppressant, or immunomodulating agents may further increase
the risk of infections, including PML and other opportunistic
infections, over the risk observed with use of TYSABRI alone."

          The plaintiffs allege that the use of TYSABRI in
combination therapy was highly material to TYSABRI's future market
share because approximately 180,000 patients or "slightly over half"
of the potential MS market was on other MS drugs. CAC ¶ 180.

                 a.  Waiver

          Before addressing the merits of the argument, we look to
whether it has been waived. The defendants argue that this
combination therapy theory has been waived because plaintiffs did
not brief it in their opposition to the motion to dismiss. Further,
the district court did not comment on the theory at all.

          The theory is, however, plainly stated in the amended
complaint. See CAC ¶¶ 402-404. It was the defendants' motion to
dismiss which failed to mention or brief the theory, thus failing to
call the court's attention to it. Plaintiffs may have been unwise
not to brief the theory in their opposition and thus be sure the
district court was aware of it. However, plaintiffs did refer to the
theory, albeit briefly, at oral argument in the district court.
Defendants' failure to brief in their motion to dismiss a theory
raised by the complaint should not be rewarded by finding waiver by
plaintiffs. Cf. Peterson v. Highland Music, Inc., 140 F.3d 1313,
1318 (9th Cir. 1998) (finding that defendants did not waive on
appeal its defense of lack of personal jurisdiction when, in the
absence of any allegations of "deliberate, strategic behavior,"
defendants contested jurisdiction only in their initial pleading and
did not raise the issue again until appeal). Neither side advances
the cause by hiding the ball from the district court. Cf. Adden v.
Middlebrooks, 688 F.2d 1147, 1156-57 (7th Cir. 1982) (finding no
waiver by defendants even though defendants never raised issue after
initial pleading until supplemental briefing was ordered by the
appellate court, but warning that "[defendants] are well advised to
brief fully all grounds . . . in their favor").

                 b.  Merits

          On the merits, the plaintiffs' theory -- that defendants
had no reasonable basis to say at the time they made their
statements that TYSABRI was safe in combination with AVONEX -- is
not nearly as compelling as opposing inferences from the undisputed
facts in the record. First, and most importantly, at the time these
statements were made, the FDA had approved TYSABRI for use with
AVONEX after contemplating any safety risks. In the FDA's medical
review of the drug before approval, the FDA analyzed data from the
first year of the SENTINEL trial, which tested TYSABRI in
combination with AVONEX. In the "Safety" section of the review, the
FDA noted that "[n]atalizumab's overall safety profile was similar
in Studies 1801 [TYSABRI as a monotherapy] and 1802 [TYSABRI in
combination with AVONEX]," suggesting that "co-administration of
[AVONEX] does not necessitate a change in that natalizumab dose to
maintain safety." Biogen included similar language as part of the
original package insert label accompanying TYSABRI. Addendum to
Defs.' Br. at 5.

          Plaintiffs point to this language in the original label as
evidence that defendants falsely implied that TYSABRI was safe when
used in combination with AVONEX. When viewed along with the FDA
review described above and the new package insert label after
TYSABRI's re-introduction, the inference of scienter is less than
compelling. The original label's "Indications and Usage" section,
which described the FDA-approved uses of the drug, noted
that: "TYSABRI® is indicated for the treatment of patients with
relapsing forms of multiple sclerosis." Addendum to Defs.' Br at 4.
The new package insert label specifically states that TYSABRI should
be used on its own: "TYSABRI® is indicated as monotherapy for the
treatment of patients with relapsing forms of multiple
sclerosis . . . ." Joint App'x at 538 (emphasis added). Also, as
discussed above, the label comes with a warning of the risk of
TYSABRI when used in combination with other MS therapies.

          Based on these undisputed facts, we find the defendants'
inference more compelling: up until the first diagnosis of PML, no
significant safety risk had been associated with use of TYSABRI as a
combination therapy. To the contrary, one of the clinical trials
(SENTINEL) was focused on the safety and efficacy of TYSABRI in
combination with AVONEX. Once the diagnoses of PML occurred and the
drug was withdrawn, Biogen recognized that a safety risk may exist
when TYSABRI is used as a combination therapy because the two
instances of PML had occurred in the SENTINEL trial. This was
reported to the FDA and discussed in the Advisory Committee
hearings. When the FDA re-approved the drug for use in June 2006, it
was only as a monotherapy, and Biogen disclosed this in the label
accordingly.

          Defendants may have based their optimistic financial
projections on a broader market that includes TYSABRI being used
with AVONEX. But plaintiffs have not raised a plausible inference
that defendants knew at the time these projections were made that
TYSABRI used with AVONEX was unsafe. As a result, we cannot say that
either defendants' representations about TYSABRI as a combination
therapy or the ensuing forecasts about market share were misleading
at the time they were made. There is no strong inference of scienter.

          3.    Insider Trading Allegations

          If there is reason to be concerned about material omissions
or misrepresentations, the presence of insider trading can be used,
in combination with the other evidence, to establish scienter.
Boston Scientific, 523 F.3d at 92; Greebel v. FTP Software, Inc.,
194 F.3d 185, 197-98 (1st Cir. 1999); Shaw v. Digital Equip. Corp.,
82 F.3d 1194, 1204 (1st Cir. 1996).

          Here, we have already discounted the inferences of scienter
from claims about failure to disclose the risk of non-PML
opportunistic infections and of safety concerns with combination
therapy. Even if defendants' statements were arguably misleading,
plaintiffs have not sufficiently alleged that the statements were
intentionally so; that is, that defendants had any reason to know
their statements were misleading before February 18, 2005, the day
of the meeting where the defendants first learned of the PML
diagnoses. Thus, any insider trading which occurred during the class
period until February 18, 2005 cannot be used to support a strong
inference of scienter, since "[i]nsider trading cannot establish
scienter on its own."

                    We need not address the defendants' arguments
thatdefendant Rohn's trading was immunized because of its proximity
tohis retirement and that much of the individual defendants'
tradingoccurred pursuant to Rule 10b5-1 plans. An examination of
publiclyavailable SEC filings shows that at least two defendants,
Rastetterand Adelman, entered into Rule 10b5-1 plans during the
classperiod. See, e.g., Biogen Idec Inc., Form 8-K: Current
ReportPursuant to Section 13 or 15(d) of the Securities Exchange Act
of1934 (SEC File No. 0-19311, Dec. 13, 2004), Item 8.01
(Rastetterentered into two plans on December 13, 2004); Biogen Idec
Inc.,Form 8-K: Current Report Pursuant to Section 13 or 15(d) of
theSecurities Exchange Act of 1934 (SEC File No. 0-19311, Oct.
18,2004), Item 8.01 (Adelman entered into a plan on October 18,
2004).


Close Boston Scientific, 523 F.3d at 92.

          We are, however, concerned by the only allegations of a
sale on or after February 18, 2005: the allegations that Bucknum,
the General Counsel, sold 89,700 shares for total proceeds of
approximately $6 million on February 18, 2005. The SEC investigated
this sale and an agreement was reached under which Bucknum disgorged
profits of $3 million. As best as can be inferred from the documents
in evidence, Bucknum proposed his sale to his broker at 8:45am,
Biogen's legal department approved the sale at 10:00am, the meeting
at which PML was discussed was at 12:00pm, and Bucknum instructed
his broker to sell the shares at 1:30pm. Plaintiffs do not allege
that any individual defendant knew before the noon meeting of the
patient death from PML, that an agenda containing that information
was circulated in the morning, or even who first learned the
information and when. There is no allegation that Bucknum knew of
the information before he sought permission to sell the stock.
Perhaps Bucknum acted on insider information in the sense of failing
to refrain from trading once he learned of the PML death. It is
notable that plaintiffs excluded Bucknum from their section 10(b)
claim; the claim is against Biogen and the other individual
defendants. But no one else among the defendants traded that day.

          Based solely on Bucknum's trading, a strong inference of
scienter on the part of Biogen and the other individual defendants
cannot be drawn.

                    Plaintiffs may be arguing that Bucknum himself
violatedan independent duty to disclose under section 10(b) because
he didnot abstain from trading after learning of the incidences of
PML. See Shaw, 82 F.3d at 1203 ("There is no doubt that an
individualcorporate insider in possession of material nonpublic
informationis prohibited by the federal securities laws from trading
on thatinformation unless he makes public disclosure."). We need
notdecide this issue, however, because plaintiffs elected not
topursue a section 10(b) claim against Bucknum as an individual.

                    If the plaintiffs are arguing that Biogen itself
had aduty to disclose because of Bucknum's trading, that proposition
isunsupported by the law. The duty to "disclose or abstain"
carriesover to the corporation when the corporation itself trades in
itsown stock, and there is no such allegation here. See, e.g., id.
at1203-04; San Leandro Emergency Med. Group Profit Sharing Plan
v.Philip Morris Cos., 75 F.3d 801, 814-15 (2d Cir. 1996).


Close See Abrams v. Baker Hughes Inc., 292 F.3d 424, 435 (5th Cir.
2002) (noting that "even unusual sales by one insider do not give
rise to a strong inference of scienter" when other insiders had not
engaged in suspicious trading during the class period); see also,
e.g., Southland Sec. Corp. v. INSpire Ins. Solutions, Inc., 365 F.3d
353, 369 (5th Cir. 2004); San Leandro Emergency Med. Group Profit
Sharing Plan v. Philip Morris Cos., 75 F.3d 801, 814 (2d Cir. 1996);
Acito v. IMCERA Group, 47 F.3d 47, 54 (2d Cir. 1995). Moreover,
Bucknum made none of the statements alleged to be misleading, and
there is no specific allegation that Bucknum was any more
knowledgeable than any of the other individual defendants. See
Ronconi v. Larkin, 253 F.3d 423, 436 (9th Cir. 2001) ("One insider's
well timed sales do not support the 'strong inference' required by
the statute where the rest of the equally knowledgeable insiders act
in a way inconsistent with the inference that the favorable
characterizations of the company's affairs were known to be false
when made." (footnote omitted)).

          What is clear is that neither Biogen nor any other
individual defendant sold any shares during the class period after
they learned of the PML death on February 18. No strong inference of
scienter in plaintiffs' favor arises in an absence of insider sales
by these defendants.

D.       New Claims About Shortened Class Period on Motion
To Dismiss

          1.    Lateness of Assertion of Claim

          The plaintiffs filed four successive complaints in this
matter over a period of twenty months before oral argument on the
motions to dismiss on September 11, 2007.

                    They also sought to file yet another complaint
after thecourt entered a dismissal order.


Close Despite ample opportunity to assert their claims earlier,
plaintiffs came up with a new theory, the shortened class period
theory, in their memorandum in opposition to the motion to dismiss.
The district court permitted argument on the theory but was not
persuaded. Indeed, the court does not discuss the theory at all in
its memorandum supporting its ruling on the motion to dismiss.

          Defendants argue the theory was waived. Our concern about
theories raised for the first time by plaintiffs in response to
defendants' motions to dismiss in securities cases is based in part
on traditional notions of waiver and in part on the unusual
requirements of the PSLRA. In enacting the PSLRA, Congress intended
to raise the standards plaintiffs must meet to survive a motion to
dismiss, for defendants to have a fair chance to test the viability
of a complaint, and for courts to carefully scrutinize complaints.
See Tellabs, 127 S. Ct. at 2509. That deliberate scheme is thrown
into disarray when new theories are first produced in response to a
motion to dismiss. The need for clarity and specificity about what
plaintiffs' theories actually are is undercut. The PSLRA did not
impose special burdens on Fed. R. Civ. P. 15(a), regarding
amendments of complaints. See ACA Fin., 512 F.3d at 56. But
plaintiffs here did not attempt to present this new theory in any of
their amended complaints. That meant neither the court nor
defendants had prior notice of the theory, much less prior
opportunity to consider whether the theory met the PSLRA standards.
The district court would have acted well within its discretion in
declining to permit advancement of the new theory. And in future
cases, honoring the purposes of the PSLRA, we may decline to hear
arguments challenging dismissal based on belatedly advanced theories
not contained clearly in amended complaints.

          2.    Merits of Shortened Class Period Claim

          Here, even considering the theory, it fails.

          There was a ten-day period between the earliest knowledge
on February 18, 2005 of one PML death and the potential PML
diagnosis of a second patient, and the announcement on February 28,
2005 that TYSABRI was being withdrawn due to the PML diagnoses. That
was a reasonable period of time for defendants to make their
disclosures.

                    The district court reasoned at oral argument that
thetheory must fail because defendants had no duty to disclose in
thatperiod because they made no public statements. However,
becausethere had been prior statements about the drug's risks which
wouldhave been material to Biogen's financial health, there was a
dutyto disclose within a reasonable time. See Cabletron, 311 F.3d
at36 (noting a duty to correct prior statements in light
ofsubsequent developments). There is no need to discuss whetherthere
were other sources of an obligation to disclose.


Close See Higginbotham, 495 F.3d at 761 ("Managers cannot tell lies
but are entitled to investigate for a reasonable time, until they
have a full story to reveal.").

          At a minimum, Biogen needed to understand whether PML was
caused by TYSABRI. This entailed understanding whether both patients
with PML had any medical history showing they were susceptible to
PML and sorting through whether, if there were a causal connection,
it involved TYSABRI alone or an interaction between TYSABRI and
AVONEX, since both patients were participating in the combination
trial. During the ten-day period, the company was also cooperating
with the FDA.

          The company would have behaved irresponsibly (and possibly
in violation of the securities laws) if it had made a public
announcement which was possibly inaccurate because the situation of
the PML incidences had not yet been adequately investigated. This
obligation on drug companies to investigate and to be accurate in
their material public statements holds even when the adverse
information comes from clinical trials on drugs to treat very ill
patients. See id. at 758 ("Knowing enough to launch an investigation
([the defendants] could not simply assume that the initial report of
bad news was accurate) is a very great distance from convincing
proof of intent to deceive."); id. at 760-61 ("Prudent managers
conduct inquiries rather than jump the gun with half-formed stories
as soon as a problem comes to their attention."); cf. Carter-Wallace
I, 150 F.3d at 157 ("Drug companies need not disclose isolated
reports of illnesses . . . until those reports provide statistically
significant evidence that the ill effects may be caused by -- rather
than randomly associated with -- use of the drugs and are
sufficiently serious and frequent to affect future earnings.").

IV.

          Because the complaint has not pled a strong inference of
scienter against either Biogen or any of the individual defendants,
we do not reach the question of whether it is possible to raise a
strong inference of scienter against the company without doing so
against any individual defendants. See Teamsters Local 445 Freight
Div. Pension Fund v. Dynex Capital Inc., No. 06-2902, ___ F.3d ___,
2008 WL 2521676, at *4 (2d Cir. June 26, 2008); Makor Issues &
Rights, 513 F.3d at 710.

          In addition to their claims under section 10(b) and Rule
10b-5, the plaintiffs pled claims under sections 20(a) and 20A of
the Securities Exchange Act of 1934, 15 U.S.C. §§ 78t(a) and 78t-1.
Because we have found that plaintiffs have not adequately alleged an
underlying 10b-5 violation, those claims must fail. See ACA Fin.,
512 F.3d at 67-68; In re Stone & Webster, Inc., Sec. Litig., 424
F.3d 24, 27 (1st Cir. 2005); In re Advanta Corp. Sec. Litig., 180
F.3d 525, 541 (3d Cir. 1999).

          The decision of the district court is affirmed.

HADCORP NEWS: August 20, 2008

Leading Story:

French doctor accused in plastic surgery scam arrested in Spain

(AFP)
Khaleej Times
Dubai, United Arab Emirates

19 August 2008

MARSEILLE, France - A French cosmetic surgeon who went on the run
after being tried for mutilating and endangering the lives of dozens
of men and women has been arrested in Spain, police sources said on
Tuesday.

Michel Maure, who told investigators he was one of the world's best
plastic surgeons, went on trial in June in the southern French city
Marseille on charges of false advertising, deception, and causing
involuntary injury.

The verdict was due in September, with prosecutors calling for a
four-year prison sentence and a fine of 75,000 euros (110,000
dollars) but he went missing in July despite a court order
restricting his movements.

A European arrest warrant was issued and he was finally arrested
Tuesday in Rosas in northeastern Spain, the French police source
said.

Nearly 100 victims had lodged complaints against Maure, 59.
Investigators have said that since 1995, the doctor had practised
illegally, describing his clinic in Marseille as a "dirty and badly
maintained facility" where his patients faced "an immediate risk of
death or severe after-effects."

Many of Maure's mostly female patients decribed his methods
as "violent." He carried out painful procedures, such as liposuction
or the insertion of breast implants, under a simple local
anaesthetic, they said.

His alleged victims have complained of chronic pain and infections.
Several have had to undergo reparatory surgery.

Maure, who claimed to be the "victim of a plot," was in 2007 struck
off France's medical register.


---------------------------------------------------------------------
-----------


After Donda West death, California Senate approves new rule for
elective surgery

Los Angeles Times
CA, USA

The measure requiring that patients be given physical exams comes in
response to the 2007 death of rapper Kanye West's mother, who died
of complications related to cosmetic surgery.

By Patrick McGreevy, Los Angeles Times Staff Writer

12:25 PM PDT, August 13, 2008

SACRAMENTO -- After the death of a rapper Kanye West's mother after
plastic surgery, the state Senate today approved a requirement that
patients be given a physical exam before elective surgery.

Sen. Mark Ridley-Thomas (D-Los Angeles) said the measure was in
response to the 2007 death of Donda West, mother of the rap
musician, of complications related to cosmetic surgery. The family
believes that a physical exam would have uncovered coronary artery
disease.

"Many of us are concerned about the quality of care extended to
those who receive elective surgery," Ridley-Thomas said.

The vote on AB 2968 was 37 to 1.


---------------------------------------------------------------------
-----------


Why Cosmetic Surgery as a Career Move is BS

U.S. News & World Report
Washington, DC, USA
August 05, 2008 02:42 PM ET | Liz Wolgemuth |

If the news about people investing in cosmetic surgery to benefit
their careers makes you cringe, you're not alone. CareerDiva blogger
Eve Tahmincioglu writes that if she sees "another story about women
getting plastic surgery or getting Botox injections in order to land
jobs I am going to puke."

It's media hype, she says. The real career-boosting move is job
training.
Yes, go out and take a course or get a degree. Your money will be
better spent improving your skills and improving your mind.

I'm not saying you shouldn't reassess your wardrobe, or get a
haircut.

There's nothing wrong with trying to look your best. But we
shouldn't be ashamed of growing old. People can smell this type of
shame and that's what doesn't get you a job.

I was intrigued, particularly because I've written about career-
driven cosmetic surgery, so I asked Tahmincioglu a couple of
questions via E-mail.

Some of the more common stories of career-linked surgery came from
older women in real estate, where "customer touch" is pretty high.
For those sorts of jobs, how can one keep up an appearance of
freshness and relevancy? Is it just job training?

And patients often speak of the confidence that cosmetic surgery
gives them. If a person fits that mold—where physical appearance is
so important to them—do you think that quality alone suggests
they're not leadership material? Do leaders, in general, find their
confidence elsewhere?

Tahmincioglu's on vacation, but she responded because "the 'be-
youthful-no-matter-what' mantra I've been hearing lately needs to be
reality checked." Here's her very thoughtful response (emphasis is
mine):

I've blogged about this often at CareerDiva because I'm getting more
and more readers asking whether their age may be impacting their job
search negatively, and also because I'm seeing so many stories about
women who have chosen plastic surgery or Botox to help their
careers.

In the case of Realtors, and others who are close to the public on a
regular basis, it's about knowing your business. Home buyers and
sellers want someone who knows a particular market... the
neighborhoods that are hip; tips on how to make your home more
attractive to buyers; are homes priced right, etc. That said, first
impressions can be everything. And that starts with the photo of a
real estate agent on the website and on the home signs they put up.
Get a professional photo taken. I don't care how much plastic
surgery you get, a bad photo is a bad photo, and it will turn people
off. That's in any industry where you use a photo for the service or
product you're selling.

And if you're in a high "customer touch" job, especially one where
you need to move around a lot, the first thing you should be
thinking about is being fit. I often scratch my head when I see men
and women who spend so much money on rearranging their faces
surgically but get winded when they climb a flight of stairs. People
gravitate to individuals who are full of energy and vigor. They know
you can get the job done.

And I'm a big advocate of updating your fashion sense. I was a
reporter for Women's Wear Daily early on in my career and there was
something to be said about just the right outfit that enhanced your
best features. Not everyone is good at figuring out what works best
for them, and buying a bunch of fashion magazines will only make you
ill. If you're really in the dark, I'd hire a professional image
consultant or stylist who can help you find the right wardrobe. You
want to look age appropriate but you also want to look hip.

As for leadership, I've interviewed hundreds of CEOs and top dogs at
corporations during my career, and 55 in my book, From the Sandbox
to the Corner Office, and let me tell you, these men and women oozed
confidence. It came from within. The majority I have interviewed did
not have plastic surgery. But they looked pulled together, fit, and
seemed to always dress right. Most seemed to spend a lot of money on
their wardrobes and their hairstyles. Quick snapshot on why, I
think, they are so confident—they admit mistakes; they ask for help,
and seek out mentors; and they were not afraid of paying dues during
their careers and learning from the ground up.

Frankly Liz, I don't buy this confidence-with-surgery BS. People
with low self-esteem, or individuals who have become obsessed with
aging, are looking for quick fixes to help them when they walk into
that job interview. It's a stressful moment. There is no debating
that. But doing your homework about a company you want to work for,
or staying on top of the changing landscape of your industry, is how
you gain real confidence when you're face to face with a hiring
manager or a customer.

It's easy to blame your wrinkles for why you're in a career abyss.
While I know there is a lot of age discrimination in the workplace,
I think the 40-plus crowd is actually helping prop up this bias
today. Why? We don't even like ourselves. We walk around like sad
sacks wondering why the Gen X hipsters don't want to be our Facebook
friends.

What ever happened to the "we're in charge of our own destinies"
generation? Maybe we need an old fogy Woodstock to help us all feel
better about what is inevitable, folks--growing old. Embrace it,
don't try to erase it.

The botox battles

By JUDY SIEGEL-ITZKOVICH
Aug 3, 2008 21:38 | Updated Aug 4, 2008 10:39
Jerusalem Post
Israel

The head of the Israel Medical Association's ethics bureau has
attacked plastic surgeons who place illegal advertisements,
aggressively market needless operations and "use people" to make
their fortunes.

Prof. Avinoam Reches, who is also a senior neurologist at Hadassah
University Medical Center, was speaking on "The Ethics of Esthetics"
at Thursday's all-day Israel Medical Convention, organized by
Hadassah and two other hospitals and sponsored by a variety of
groups at the Jerusalem International Convention Center.

Reches said esthetic surgery was a NIS 500 million to NIS 600m.
industry in Israel, and presented dozens of advertisements from
newspapers and Web sites in which plastic surgeons promised to make
people "beautiful," based on exaggerated expectations, and change
their lives.

Some unethical practitioners offer journalists a free makeover and
then expect them to write flattering copy, according to Reches. One
ad shows a doctor wrapped in (false) bandages and sitting in an
idiotic pose on a surgical table to promote his specialty. This,
insisted Reches, was "an embarrassment to the medical profession."
Such physicians "create mass psychoses and turn doctors
into 'renovators' of the human body."

Some plastic surgeons offered "Botox parties" to which women were
invited as a group and underwent injections for their wrinkles one
after another, Reches said. Promotions for "discounted" plastic
surgery appear in catalogues along with TVs and vacuum cleaners. He
conceded that public hospitals, including Hadassah's for-pay
Hadassah Optimal, offered esthetic surgery that was not covered by
health funds, and that their standards were much higher and not
aggressively marketed.

Although doctors were permitted to advertise, they could not include
prices or make exaggerated claims about their skills and experience,
Reches said.

Most of the advertising violations investigated by the IMA's ethics
bureau involved plastic surgeons, he said. "They buy whole pages in
newspapers and invent questions that they answer. They create
diseases that don't exist and illegally give names of famous people
who used their services. They also display parts of the body that
may not be published in such ads."

Dr. Roni Moscona, an experienced plastic and reconstructive surgeon
at Rambam Medical Center in Haifa and the private Ramat Aviv Medical
Center, said he could defend his profession but not doctors who
advertised and made exaggerated claims. "I believe that a doctor
will get patients if he is a good doctor; the word spreads," Moscona
said.

Although plastic and reconstructive surgeon can't claim to save
lives, Moscona said, it did improve the quality of life of many
patients, and satisfaction rates in the US, for example,
were "between 80 percent and 90% - a figure that no other medical
specialty can beat."

As no parent would hesitate to improve a child's looks with
orthodontic treatment, Moscona added, there was no reason why people
who were disfigured or terribly unhappy with their body should not
try to change them. But he denounced surgeons who performed
unnecessary surgery, as on the now-deformed Michael Jackson, and
said doctors were now allowed to advertise within limits, thanks to
a Supreme Court decision by then court president Aharon Barak.

Moscona criticized the Health Ministry for allowing companies to put
its stamp of approval on products that falsely claimed to improve
the shape of breasts "without surgery or pain," and showed an ad
that said it even had kashrut approval from the Rabbinate. Ministry
approval means only that something is not harmful to health - but
not that it offers any benefit.

Moscona said he had hundreds of letters from patients who said
he "changed their lives" by eliminating physical deformities.


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Surgeons, doctors in cosmetic face-off

The Age
Melbourne, Victoria, Australia
Louise Hall
August 3, 2008

A pledge by health ministers to develop national standards on
cosmetic surgery is likely to be derailed by the long-running turf
war between plastic surgeons and self-styled cosmetic surgeons.

Federal Health Minister Nicola Roxon announced last month that her
department would look into toughening the laws surrounding the
industry, which has come under fire following horror stories of
botched operations and the deaths of two young women following
liposuction.

Plastic surgeons say recent NSW legislation to clamp down on
advertising, such as fake before and after shots, and a mandatory
cooling-off period for people under 18, does not go far enough.

But the industry is unlikely to agree on the clarification of titles
such as "cosmetic surgeon" and "specialist" to clear up the
confusion among consumers, with both sides refusing to give ground
in the feud that has been running since 1999.

Dr Norman Olbourne from the Australian Society of Plastic Surgeons
says any doctor with a basic medical degree should not be able to
call him or herself a cosmetic surgeon or specialist.

He called on NSW to adopt Queensland's approach, in which the
word "surgeon" can only be used by fellows of the Royal Australasian
College of Surgeons, who have undertaken eight years of postgraduate
surgical training.

They are banned from performing cosmetic surgery on under 18s.
While rivals, including the Australasian College of Cosmetic
Surgery, agree on the need to rid the industry of "grandiose titles
[that] mean nothing more than a paid subscription fee", they dispute
the college of surgeons' assertion that it is the only group
qualified to perform cosmetic surgery.

"Our college provides appropriate training in cosmetic surgery
whereas plastic surgeons are trained in the public system, where
there [are] no cosmetic patients to give adequate training," ACCS
chief executive John Flynn said.

"Cosmetic surgery is a distinct and separate speciality."

At the Australian Health Ministers' Conference last month, South
Australian Health Minister John Hill urged his state and federal
colleagues to consider a number of cosmetic surgery regulations.

They included a surgery ban on under 18s, that a patient's first
consultation be with a medical practitioner rather than
a "commission-rewarded lay adviser", a psychological assessment be
done of a patient's suitability for cosmetic surgery and mandatory
assessment by two doctors.


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Seven O.C. docs disciplined by state medical board

Thursday, July 31, 2008
OCRegister
Santa Ana, CA, USA

Their violations include wrong-site surgery, misdiagnosis of breast
cancer and use of experimental wrinkle treatment.

BY COURTNEY PERKES

Seven Orange County doctors have been disciplined by the California
Medical Board for infractions ranging from failing to properly treat
a post-surgical wound to injecting patients with an experimental
Botox-like drug. Two more have been accused of wrongdoing and face
possible discipline.

Here are the doctors named in the state's July round-up of
discipline:

Dr. Gonzalo Covarrubias, an orthopedic surgeon from San Juan
Capistrano, was put on seven years of probation. According to state
documents, Covarrubias committed "gross negligence" in his treatment
of a 60-year-old diabetic patient by failing to properly treat an
open wound for more than two months after surgery. The patient was
eventually treated for meningitis and sepsis. He cannot practice
medicine until he completes a clinical training course. Covarrubias
is on vacation and could not be reached for comment.

Dr. George Georgeson, a Garden Grove pediatrician, had his license
revoked after submitting forged letters of recommendation to a
specialty college in England. He could not be located by the board
and did not contest the accusation.

Five other doctors received public reprimands, the least severe
discipline:

Dr. David Chang, an anesthesiologist from Irvine, was reprimanded
for failing to keep an ear, nose and throat surgeon on standby
during a difficult case of administering general anesthesia. Board
documents say the 70-year-old patient had a swollen neck and was not
getting enough oxygen. An ENT surgeon eventually performed an
emergency procedure to open the airway, but the patient died.

"We don't think it was a violation or any negligence on his part,"
said Chang's attorney Peter Osinoff. "It's a way of resolving this
without maximum costs."

Dr. Richard Huberman of Newport Coast received a reprimand after he
was disciplined by the medical board in North Carolina for
performing surgery on a patient's wrong heel. A receptionist at his
former North Carolina office said he has retired. He could not be
reached for comment.

Dr. Joseph Manzini, a Huntington Beach dermatologist, received a
reprimand for administering a wrinkle-treatment that was not
approved by the Food and Drug Administration. According to board
documents, Manzini administered an experimental Botulinum Toxin to
10 patients. Last year, Manzini pled guilty to an interstate
commerce violation and was sentenced to two years probation.

His attorney Robert Sullivan said Manzini and other doctors ordered
the drug at medical conventions without knowing it was not allowed
for use in patients.

"More than 100 California physicians bought it thinking it was
suitable and received reprimands from the board," Sullivan
said. "The doctors were looking for a product that was cheaper for
their patients."

Dr. Jyotinkumar Patel, a family practitioner from Laguna Niguel,
received a reprimand for his treatment of a breast cancer patient
who later died. According to medical board documents, Patel
initially diagnosed a lump as a chest sprain. He was also faulted
for illegible chart notes.

Patel's attorney Raymond McMahon said Patel has moved to electronic
medical records to avoid future record keeping issues.

"He's an excellent, really caring physician," McMahon said.

Dr. Edward Stadler, a Mission Viejo gynecologist, received a
reprimand for failing to adequately treat a patient's breast mass.
According to state documents, Stadler treated a patient's
undiagnosed mass with estrogen therapy and failed to assist the
patient in obtaining the tests he recommended. McMahon, who also
represents Stadler, said his client acted appropriately.

"He identified the mass. He referred the patient for a mammogram and
an ultrasound. She did not follow up," McMahon said.

Here are the doctors facing possible medical board discipline:

Dr. Frederic Corbin, a plastic surgeon practicing in Brea and
Beverly Hills, is accused of using non-FDA approved silicone breast
implants. He pled guilty to performing breast augmentation surgeries
with silicone breast implants that at the time were not approved for
use in the United States. He was sentenced to one-year probation and
community service. Corbin did not return a phone call but previously
told The Register the charge was "spurious."

Dr. Brendan Mull, a pediatric neurologist from Anaheim Hills, is
accused of an act of violence and not being safe to practice.
According to board documents, last fall UC Irvine Medical Center won
a restraining order against Mull after he assaulted a psychiatrist,
who was evaluating him for depression. Mull could not be reached for
comment.

To look up a doctor's disciplinary record or file a complaint
against a doctor, call 800-633-2322 or go online to the California
Medical Board site.

California Medical Board discipline definitions

Accusation: A formal, public charge by the board alleging a
physician violated the Medical Practice Act. This is the result of a
fully investigated complaint that has been referred to the Attorney
General's Office for prosecution. Practice is permitted unless
otherwise specified.

Public reprimand: Licensee was reprimanded for a minor violation(s)
of the law.

Probation: Probation is the result of disciplinary action. Probation
is ordered for a specified period of time during which the physician
must comply with specified terms and conditions and report to a
board probation monitor. Practice is permitted unless otherwise
specified.

License revoked: License has been revoked as a result of
disciplinary action rendered by the board. No practice is permitted.


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MEDICAL DEVICE NEWS


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Widow wins $1.54M malpractice verdict

Huntington Herald Dispatch
Huntington, WV, USA
Aug 18, 2008 @ 10:00 PM
By CURTIS JOHNSON

HUNTINGTON -- A Cabell County jury awarded a Barboursville widow
$1.54 million in a lawsuit over a 2002 surgery that led to severe
brain damage for her husband, Thomas L. Thornburg.

After more than a week of evidence and testimony, the jury found on
Aug. 13 against Huntington Anesthesia Group Inc. In the verdict, the
jury cleared the doctor involved of any wrongdoing, but faulted a
nursing anesthetist for inadequate attention to Thornburg's vital
signs.

Surgeons were installing an automatic implantable cardiovascular
defibrillator, when the anesthesia team failed to notice
deteriorating vital signs, the jury found. A lack of breathing over
a considerable amount of time deprived oxygen to Thornburg's brain
and caused severe damage.

The device temporarily fixed Thornburg's heart condition, but the 62-
year-old man eventually died Aug. 26, 2006. Doctors faced with
repairing another cardiac episode decided not to render medical
treatment. Doctors said the final episode was treatable, but
Thornburg's total health, mental state and living conditions
influenced the decision.

The $1.54 million verdict followed a pre-trial settlement reached
with St. Mary's Medical Center, where the surgery was performed. The
hospital agreed to pay $115,000 to settle wrongful death
allegations.
Thornburg's widow declined comment Monday, but family attorney
Charlie Hatcher expressed satisfaction with the recent verdict.

"I was real glad for my client," he said. "They get some
compensation for the loss of a husband and loss of a father. That's
the whole purpose. It doesn't replace him. It's silly to think that,
but it certainly gives them some feeling that justice was done and
that is our way, in the United States, of compensating victims of
negligence."

Attorneys for Huntington Anesthesia Group Inc. could not be reached
for comment. A spokeswoman for St. Mary's Medical Center had no
comment.

The $1.54 million verdict includes $1.1 million for non-economic
losses. That exceeds West Virginia's non-economic cap by $850,000,
but the case pre-dated medical malpractice reform that decreased the
cap from $1 million to $250,000.

Thornburg's verdict also exceeded the earlier cap by $100,000, but
Hatcher said that mistake and other jury misunderstandings will be
remedied in post-trial motions. He anticipates the final award will
exceed $1.54 million.

The jury determined that Dr. Stan Striz did not deviate from the
accepted standard of care, but blamed Robert Zhea, a certified
registered nursing anesthetist.

The jurors divided the $1.54 million award among Thornburg's widow
and two children. His widow received 70 percent, while the children
received 15 percent each.

Thornburg's widow will receive 100 percent of the settlement with
St. Mary's Medical Center.


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GM FOODS


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Prince Charles: GM crops would be 'biggest ever environmental
disaster'

From Times Online
UK
August 13, 2008

Prince Charles said small farmers would be 'driven off their land
into unsustainable, unmanageable, degraded and dysfunctional
conurbations of unmentionable awfulness'

The Prince of Wales has warned the development of genetically
modified crops risked creating "the biggest disaster environmentally
of all time".

In a passionate intervention on the issue of GM food, Prince Charles
accused multi-national corporations of conducting an experiment with
nature which had gone "seriously wrong".

"What we should be talking about is food security not food
production - that is what matters and that is what people will not
understand," he said.

"And if they think also that somehow it's all going to work because
they are going to have one form of clever genetic engineering after
another then again count me out, because that will be guaranteed to
cause the biggest disaster environmentally of all time."

Charles told the Daily Telegraph that relying on huge corporations
for the mass production of food would threaten future food supplies.
He added that small farmers would be the victims.

"If they think this is the way to go we will end up with millions of
small farmers all over the world being driven off their land into
unsustainable, unmanageable, degraded and dysfunctional conurbations
of unmentionable awfulness then you count me out. I think it will be
an absolute disaster."

Charles's intervention comes at a time when soaring food costs and
shortages are putting more pressure on the GM debate.

The price of food has been pushed up worldwide by poor harvests,
some of which may be due to climate change, rising fuel prices,
market speculation and the diversion of land into biofuel
production.
The biotech industry says GM technology can be used to tackle hunger
and poverty by delivering higher yields and reducing the use and
therefore cost of pesticides.

And earlier in the year, Environment Minister Phil Woolas suggested
that opposition to genetically modified crops may have to be
rethought in the light of the global food crisis.

However, green groups and aid agencies fear claims about the
potential benefits are not being borne out in practice. Critics say
there is no evidence to show GM crops boost yields.

And they warn that rather than tackling poverty in developing
countries, much of the GM crops grown - the vast majority of which
are in North and South America - are used for animal feed or
biofuels.

Charles, who has an organic farm on his Highgrove estate, told the
newspaper he wanted to see more family run co-operative farms.
He denied this was trying to turn back the clock and said farmers
must work with nature and not against it.

At the end of last month, scientists told the Government field
trials of GM crops in the UK need better protection to allow
researchers to assess their benefits.

They said the location and details of small-scale trials could be
kept from the public to prevent them being vandalised by anti-GM
protesters.

And they said the number of field trials had declined in recent
years because of sabotage, damaging the UK's ability to inspire
innovation and commercial investment.

A Defra spokeswoman said: "As we have said many times, there is an
important debate to be had on the potential role of GM crops in the
future, and we welcome all voices in that debate.

"Safety will always be our top priority on this issue."





Thank you for supporting Hadcorp!

http://implants.webs.com/

I am a plastic surgeon trained in Microvascular surgery. 'Growing up'
in my specialty, the standard was the TRAM flap. I never did one,
realising as did one of my colleagues who described it as 'the rape
of the abdomen'--removing the abdominal integrity. Tissue expansion
with implants a) Pushes the chest wall inward and is painful b)Needs
multiple touchups c)was never lifelike. In 1999, I did about ten DIEP
flaps. All were uniformly successful and, without doubt, resulted in
THE BEST reconstruction I have ever done . It required two surgeons.
The remuneration did not cover the day's office expenses for either
of the surgeons involved. That being the standard, and, not being
able to make a living out of a 'loss leader', I elected not to
perform a 'lesser procedure'. I have therefore ceased doing breast
reconstruction. I do not live in Manhattan where CASH is paid. Where
I live,there is NO cash. Insurance companies pay no more than $2800
as opposed to Dr. Levine's Manhattan patients who can easily fork out
$15500. This represents the inequalities of healthcare that need to
be redressed. Really, if the end of our present healthcare system is
referred to as it's death, then the next phase will be defined
by 'Death, the leveller'--Dr Levine will be getting reimbursed as we
do in rural America
— Ian, Pensacola

Once again the so called auditors for the claims centre determined it
is to premature to allow the other funds we are owed to be released
till a better pattern of filing and payments is shown. If 5 years
into this they are claiming that there is not suffiecient reasons to
release this money then what it tells me is that this claims cengtre
is not qualified to be doing these claims. It means they are more
than likely doing this on purpose to stall payments to the women.

Bear in mind this fund is coming up to 5 years with alot of us not
paid properly and with the incompetent judge still not making her
ruling on the and or issue which she has also had 5 years to make the
ruling.

So the way I look at is is the independant auditors have no
intentions of saying anytime soon to release the funds as they are
making money from doing this. The claims centre keeps alot of people
employed by not paying these claims out.

The judge well she takes her direction from Dow which is very obvious
so don't expect her to get off her ass and make a ruling on something
that to me is illegal.

Then we have the claimants committee who is not putting any pressure
on this judge to make a ruling so we have to start slamming them with
emails and letters to this judge to get of there butts and do there
jobs.

There is no representation for the women, there is no lawyers out
there looking out for the women the reason why is they get paid no
matter what.

Ruptures are being denied because Dow who is running this lawsuit
doesn't want Pierre Blais or Dr guidoins analysis used as it shows
dow for the criminal liars they are.

The tort committee well what is there function? Why did we get
settlement packages with the word AND clearly stated in it? Is there
a reason the Claimants committee is OK with this judge not ruling?

Why is none of our lawyers getting upset? Did they know the word AND
was not the real word used were we lied to in order to get us to vote
yes on this disgusting settlement. Everything seems to be leading to
this.

Whether some of us were paid or not does not mean we do not support
the women who are being screwed over. If we don't do it no one else
will after all this case has not or ever been about us it has been
about the millions paid out to attorneys and others who have profited
of our backs.

So we need to start raising this issue until someone offers to help
the many women who have not been paid and those of us who are being
screwed over by the non action of the judge and others.

Sandra