Hadcorp News: April 26, 2008
Germany Bans Children From Getting Cosmetic Surgery
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.
STEM CELL RESEARCH AND TECHNOLOGY
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
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
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
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
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
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.
MEDICAL DEVICE NEWS
Lawyer sued for not filing medical malpractice papers against
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
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
"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
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.
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
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
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
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
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
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
Dental Fillings: Old School vs. New School
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
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
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
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
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
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??"
Lou Gehrig's disease patient takes to D.C.
Veterans are twice as likely to get ALS; Ken Patterson wants
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
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,
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
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.