Calling for a continued and expanded effort to protect and support Men Who Have Sex With Men (MSM), transgender and‘hijra'community in the country, the India HIV/AIDS Alliance (Alliance India) has emphasised the need for sustained investment and support to ensure that the spotlight is on this marginalised group.
Creating awareness about HIV-TB co-infection, training counselor
New Delhi: 30th November 2011
To create awareness on HIV-TB co-infection among People Living with HIV/AIDS (PLHIV), non-government organisation Global Health Advocates, India, organised a workshop, ‘TB-HIV Patient Advocates Workshop', on Tuesday to train this group as treatment educators and counsellors to work with the community.
HIV rate dropping in city: 4,440 last year, 3,228 this year
Pune: 29th November 2011
This year Pune showed fewer new HIV infections compared to last year. A total of 3,228 new HIV infections were detected from January till October this year as against 4,440 last year, according to Pune State AIDS Control Society (PSACS). From January till October this year, out of 83,649 samples that were tested, 3,228 new HIV cases were detected, said PSACS nodal officer Dr R R Bamble. Of these, 1,614 men, 1,420 women, 179 children and 15 eunuchs tested positive.
Bringing positive life to positive children Belgaum (Karnataka) |29th November , 2011
They sit on a mat in a modest building, innocent eyes wandering while a blackboard in the background reads "all is well". Parvati and Amar (names changed) are as talented and active as anyone else their age but have been discarded by their kin for being HIV positive. Parvati is a student of Class 6 in a Karnataka government school and has been the topper of her class while Amar is the captain of his school.
Panel on health coverage addresses World Bank concerns
New Delhi: 28th November 2011
The High Level Expert Group on Universal Health Coverage for India on Sunday held a brainstorming session here to address concerns raised by the World Bank over some of the recommendations in its report for the 12th Five Year Plan. Among the issues raised were marginalisation of the private sector and the “elimination of intermediation by insurance companies.”
Free sanitary napkins for students in government schools
New Delhi |28th November, 2011
In order to promote personal hygiene among young girls, the Delhi government Monday launched a scheme to distribute free sanitary napkins to girls studying in Classes 6 to 12. Introducing the Kishori scheme, Delhi Chief Minister Sheila Dikshit said the Delhi government and its aided schools will distribute free sanitary napkins every month to young girls studying in Classes 6 to 12.
India, Bulgaria ink healthcare deal New Delhi |28th November, 2011
India and Bulgaria signed a memorandum of understanding (MoU) on healthcare and medicine here Monday to increase cooperation in the sector, a statement said. Thedealwas signed by Health Minister Ghulam Nabi Azad and his Bulgarian counterpart Stefan Konstantinov. "Each country can learn from the experiences of the other and sharebestpracticesand success stories. The MoU would inter alia cover issues of medical services, public health and prophylactics (preventive medicine), medical science and training of medical personnel," Azad said in a statement. http://news.webindia123.com/news/articles/Health/20111128/1880552.html
Soon, policy on free treatment for poor
New Delhi: 27th November 2011
The Centre has informed the Delhi high court that it has framed a policy for free treatment of the poor by the hospitals that had received land at concessional rates. Appearing for the central government recently, advocate S K Dubey submitted before a bench of acting Chief Justice A K Sikri and Justice Rajiv Sahai Endlaw that the policy, approved by the urban development ministry, has been sent to the law ministry for its vetting before issuing a notification.
India might have to bear the burden of funding expensive treatments like second-line drugs for HIV patients and DOTS, plus for those suffering from multi-drug resistant TB. Global Fund, one of the biggest financers of India’s drive against the three killer diseases — AIDS, TB and malaria — has run out of money to pay for new programmes for the next two years due to the globaleconomic downturn. India, which has received over $1.7 billion from the Global Fund to run several of its HIV, malaria and TB projects, has no choice but to look at its domestic budget to finance the initiatives.
The Maternal Health Task Force collaborates with PLoS Medicine to create the MHTF-PLoS Collection on Maternal Health. For the 2011-2012 collection, they are calling for papers on Quality of Maternal Health Care. Deadline 1 Apr 2012
A sting Operation by NDTV reveals that well known Private Hospitals in Delhi Namely, Apollo and Fortis Hospital do not even treat poor patients with basic human dignity and respect . Article 21 of the Indian Constitution imposes an obligation on the state to safeguard the right to life of every person. Preservation of human life is thus of paramount importance. The government hospitals and Private Hospitals are duty bound to extend medical assistance for preserving human life, and now even the Private Hospitals .Failure on the part of a hospital to provide timely medical treatment to a person in need of such treatment, results in violation of his right to life guaranteed under Article21.
2nd NATIONAL CONVENTION ON CHILDREN’S RIGHT TO FOOD
20TH TO 22ND JANUARY 2012
BHOPAL, MADHYA PRADESH
Dear Friends,
We are writing to invite you to a Convention on Children’s Right to Food, to be held in Bhopal on 20-22 January 2012.
It has been more than five years since we had the first Children’s Right to Food (CRTF) Convention in Hyderabad (in April 2006). There have been many developments in the field, the campaigns, and policies in relation to CRTF in this period. We therefore feel it is time for us all to meet again to review the status of CRTF across the country, the policy and campaign developments and to discuss a plan of action for further campaign activities. This will also be a good opportunity for those working on right to food and others in children’s rights to come together.
This Convention is being organised by the Working Group for Children under Six (of the Right to Food campaign and the Jan Swasthya Abhiyan) along with representatives of other child rights networks and organisations such as FORCES, IACR, HAQ and so on. Some preliminary discussions regarding the programme have been held and the issues we felt could be the focus in the Convention are as below. The underlying theme would be to focus on ensuring state accountability for children’s right to food.
Review of status of malnutrition,
Right to Food: Exclusion and discrimination of the most vulnerable children
Review of policies on nutrition – state government, central govt and international
Implementation of Supreme Court orders
Review of status of schemes – ICDS, MDMS, NMBS/IGMSY, NRC’s, anganwadi-cum-crèches and other crèche schemes
National Food Security Bill and children
Accountability mechanisms: Political action, Budget analysis as a tool of mobilisation, Social audits on ICDS, MDMS, use of RTI,
Community management of malnutrition
Roles and concerns of nutrition, health and care workers
Corporatisation, PPP’s, Conflict of interests in Food Supplements
This will be an action-oriented convention, built around plenary sessions, parallel workshops, technical sessions, cultural activities, and more to facilitate sharing between grassroots activists from health, nutrition, child rights, right to food campaign activists/ organisations/networks.
Resources for the convention are being raised through donations from individual supporters and contributions by participating organisations/ participants. The estimated expenditure for the three days per participant is Rs. 1200. We request those who can afford it, to contribute this amount or less as the registration fee. A minimum modest registration fee of Rs 150 per person for the three days is required for participation in the convention.
A limited number of participants can be accommodated at the venue and hence we request you to confirm your participation as well as that of your organization as soon as possible. Please send your response to childrensrighttofood@...
If you are interested in being part of the programme committee, please do contact us and join. The committee comprises of individuals, not organisations. Please also send in any suggestions you may have for the programme.
We hope to see you in Bhopal.
In Solidarity,
Working Group for Children under Six (of the Right to Food Campaign and Jan Swasthya Abhiyan)
(Arun Gupta, Biraj Patnaik, Devika Singh, Dipa Sinha, Jean Dreze, Radha Holla, Sachin Jain, Samir Garg, Sejal Dand, Vandana Prasad, Veena Shatrugna and T. Sundararaman)
-- You received this message because you are subscribed to the Google Groups "RTFC-Expanded-Steering-group" group. To post to this group, send email to rtfc-expanded-steering-group@googlegroups.com
If you have not already, please sign the petition (link below) for release of trade union leader Comrade Bhagwati Sahu and join the thousands in Chhattisgarh who will hand over the signatures to the Governor on 10th December.
As you are aware, the absence of any systematic regulation of the private sector has witnessed its proliferation and raised serious concerns about standards of care. Further, the State subsidies in terms of, loans, tax waivers and other benefits for the setting up of private practice, hospitals, diagnostic centres and pharmaceuticals. While the expansion of the private sector is primarily responsible for high and increasing inequity in access to health care, its internal functioning is riddled with problems.
Sama has recently concluded a study on the provision of Free Treatment in limited number of private hospitals in Delhi, which have been provided land at subsidised rate on the conditionality of providing a certain proportion of free services (both OPD 25 per cent and IPD10 per cent) services to the Economically Weaker Section (EWS). Along with giving a picture of how such provisions are being implemented, the study also raises important questions with regard to access to health care services, equity, patient’s rights, information sharing, the laxity in regulatory mechanism and the implementation process of existing legislation among other things. These aspects also point to considerable policy concerns with regard to poor governance, absence of regulation, evaluation and systems for accountability of the private sector.
We are happy to share the report based on the pilot study of private hospitals in Delhi "Free treatment in the private sector: Myth or Reality?" which can be an important resource for highlighting these concerns. Please write to us directly (not on the e forum) if you are interested to acquire a copy.
Bold and Innovative Ideas for Increasing Vaccine Uptake.
- As submitted to vaccinechallenge.org by IACCMVSR.
[This is in email consultation with
doctors, medical scientists, advocates, media persons, public health activists, human rights activists, victims of vaccines and parents of vaccine damaged children, both in India and abroad]
Our bold & innovative ideas for increasing vaccine uptake are;
1. Conducting independent and unbiased
vaccine safety research, both short term and long term, and also research on safety about the combined effect of various vaccines given to the children.
2. Compare the health of vaccinated vs non vaccinated children.
3. Identify all cases of vaccine induced deaths and damage.
4. Compensate parents of those children who died because of vaccines. Identify children damaged and disabled due to vaccines, provide them free treatment for life, compensate them and rehabilitate them when they reach the employable age. Arrange for giving disability certificate to them so as to make it possible for them to avail all disabilty benefits.
5. Remove mercury, aluminum, phenol, squalene, polysorbate 80 and other toxic chemicals from vaccines. Ensure that all vaccines are free from zoonotic virus contamination. In DNA vaccines ensure that there is no rDNA contamination. Prevent the use of human cell lines in vaccines.
6. Inform Hindu's that bovine serum is used in vaccines, Muslims that porcine serum and gelatin is used in vaccines, and vegetarians that animal and human serum is used in vaccines.
7. Provide parents with full disclosure of all probable and possible risks from vaccines and take their written and informed consent before vaccinating their children. This should be read out to them in their own language and it should be ensured that they have properly and adequately understood and comprehended the information so provided.
8. Make it mandatory for doctors, health care workers and parents to report
vaccine injury and death to a vaccine adverse effect reporting database. This database should be kept on public domain.
9. Ensure that all required and free legal aid is given to parents of vaccine effected children or victims if they want to sue the doctor/hospital/govt/vaccine manufacturer for vaccines manufactured, sold,recommended and administered by them.
10. Set up an advanced state of the art laboratory in India and in other developing nations to independently test all vaccines for toxic ingredients, contamination related zoonotic and human viruses, junk DNA and RNA material and fragments, and for the presence of bioterrorism agents and infertility agents, hormonal or otherwise.
11. These laboratories should also test the vaccines, both single and in combination with the other vaccines administered to infants and children in schedules recommended by the govt or other public medical bodies for a minimum period of
3 to 5 years against a control who should receive a plain sugar placebo and not any other vaccine or toxic element.
12. To determine generational effects, single and combination of all vaccines routinely given to children should be tested on at least three generations of mice to know the long term effects of vaccines.
13. Doctors should sign an warranty of vaccine safety and efficacy saying that the vaccines are 100% safe and effective, contain no harmful chemicals, heavy metals, neurotoxins, contaminated viruses, zoonotic or otherwise, in animal or human serums, and that in case of vaccine damage or death they will be held personally liable for payment of damages. They will also write that they will accept the parents claim of vaccine damage and will not influence them or threaten them in any manner, verbal or otherwise, when they report so. If they do not wish to sign such an warranty of vaccine safety and efficacy they should give in writing their reasons for not doing so. The format of such an warranty has already been submitted to the Ministry of Health and Family Welfare in India but no acknowledgement of receipt has been received so far.
14. The government should through public newspaper and television advertisements inform the public regularly about all the ingredients of various vaccines, the probable and possible effects therefrom to infants and children singly and in combination, and the full range of short term and long term risks from vaccines so as to help the parents take an informed decision on the matter.
15. It should
also declare that all vaccine deaths, damages and disability, whether short term or long term, will be acknowledged and not denied, ignored or otherwise explained.
16. It should also inform the public, after public consultation and debate, the quantum of compensation that should be paid to victims and how they should be given free treatment for life, given disability status and rehabilitated once they reach employable age.
17. It should declare that pregnant women, pre term children, low birth weight children, under nourished and malnourished children, children suffering from any immunity related disorders, chronic illness, sick children, children having a family history of vaccine damage, of having a family history of autoimmune disorders or serious chronic disorders will not be vaccinated as vaccines have never been tested for safety for these categorries as it is assumed and surmised that they face the maximum risk from vaccines.
18. It should be declared that only one vaccine should be given at one time. There should be enough space between vaccines and that all further vaccines should be stopped immediately if any vaccine damage from any vaccine is noticed.It has been officially declared that at least the OPV should not be administered along with any other injectible vaccines as the paralysis can extend from the injection point. There should be a gap of two to three months between the OPV administration and any injection. A study has found that children injected for various reasons have a much higher rate of contacting polio. Polio susceptibility also increases after the DPT vaccine as per another study.
19. Adverse vaccine reactions from each vaccine or from the combined vaccines administered to the pregnant women, infants and children should be taught in detail to doctors and the subject included in their medical textbooks. They should know each condition/damage that may arise from administering vaccines and be provided a detailed protocol for dealing with all possible vaccine damage cases so as to obtain the best possible results, the target being to attain full recovery, if possible.
20. There should be a free, informative and fair debate
on vaccine risks on every possible forum with due representation of public, health activists and rights activists; this debate should be regularly carried out and all recommendations coming out of such debates should be available in public domain and should be sincerely and fairly implemented from time to time.
The committee involved in preparing this first draft recommendation reserves the right to make further changes to this draft document based upon further consultations and feedback received from time to time. The group wishes to be collectively known as The International Association of Concerned Citizen on
Matters of Vaccine Safety and Research. (IACCMVSR). The committee does not profess to represent all stakeholders on the issue who have their own right to come out with their own set of recommendations on matters of vaccine safety and research.
Dear Colleagues,
Over the last few years that we have had the Janani Suraksha
Yojana - we have had a dizzying rise in the rates of
institutional delivery. However we have little evidence about
the impact on maternal or infant well being. Instead at the
last count in the Annual Health Survey showed maternal
mortality rates are rising in many of the high focus states.
The sample size of this study was even larger than the earlier
studies. The JSY study report recently released by NHSRC shows
that for the districts they studied the maternal mortality
rate was 492 for deaths during delivery and post partum period
( pregnancy deaths were not counted). I am not arguing that
maternal mortality is rising - all I am saying is that the
reduction of maternal mortality is certainly not keeping pace
with the extraordinary rise in institutional delivery. Also
our capacity to save maternal lives - conduct C section or
arrange for blood transfusion has not increased
concommitantly.
ALSO - in many districts home births continue to happen for
whatever reasons.
Seeing the results of this review - presented below and the
studies it refers to I feel that we need to continue with TBA
training to support home deliveries where they are taking
place. We also need to focus our attention on the emergency
care linkage which saves lives during pregnancy, childbirth
and post partum care rather than focus on bringing all
possible cases to the 'institution'. I have earlier reported
on how we saw bogus institutional deliveries recorded in
Badwani district.
Institutional delivery for 'ALL' is not a good policy solution
in our context especially in the states of UP, Bihar, Orissa,
MP, Rajasthan, Jharkhand, Chattisgarh, Assam - and we should
without losing face re-start TBA training with effective
referral linkage. The focus should be quick identification of
complications - using mobile phones for back up support if
necessary and quick transportation to the nearest equipped
facility. TBA training should be standardised to include
standard set of skills including quick identification of
complications.
Please let us stop the ill considered push for universal (poor
quality) institutional delivery - the evidence is not in its
favour and let us not ignore the new evidence for continuing
with TBAs especially where SBAs don't exist.
We need to convince our decision makers at all levels.
best wishes,
Abhijit
Effectiveness
of strategies incorporating training and support of
traditional birth attendants on perinatal and maternal
mortality: meta-analysis
Amie Wilson
et al
BMJ 2011;
343:d7102 doi: 10.1136/bmj.d7102 (Published 1 December
2011)
Abstract
Objective:
To assess the effectiveness of strategies incorporating
training and support of traditional birth attendants on
the outcomes of perinatal, neonatal, and maternal death
in developing countries.
Design
Systematic review with meta-analysis.
Data sources
Medline, Embase, the Allied and Complementary Medicine
database, British Nursing Index, Cochrane Library,
Cumulative Index to Nursing and Allied Health
Literature, BioMed Central, PsycINFO, Latin American and
Caribbean Health Sciences Literature database, African
Index Medicus, Web of Science, Reproductive Health
Library, and Science Citation Index (from inception to
April 2011), without language restrictions. Search terms
were “birth attend*”, “traditional midwife”, “laybirth
attendant”, “dais”, and “comadronas”.
Review
methods: We selected randomised and non-randomised
controlled studies with outcomes of perinatal, neonatal,
and maternal mortality. Two independent reviewers
undertook data extraction. We pooled relative risks
separately for the randomised and non-randomised
controlled studies, using a random effects model.
Results: We
identified six cluster randomised controlled trials
(n=138549) and seven non-randomised controlled studies
(n=72 225) that investigated strategies incorporating
training and support of traditional birth attendants.
All six randomised controlled trials found a reduction
in adverse perinatal outcomes; our meta-analysis showed
significant reductions in perinatal death (relative risk
0.76, 95% confidence interval 0.64 to 0.88, P<0.001;
number needed to treat 35, 24 to 70) and neonataldeath
(0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170).
Meta-analysis of the non-randomised studies also showed
a significant reduction in perinatal mortality (0.70,
0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal
mortality(0.61, 0.48 to 0.75, P<0.001; 96, 65 to
168). Six studies reported on maternal mortality and our
meta-analysis showed a non-significant reduction (three
randomised trials, relative risk 0.79, 0.53 to 1.05,
P=0.12;three non-randomised studies, 0.80, 0.44 to 1.15,
P=0.26).
Conclusion:Perinatal
and neonatal deaths are significantly reduced with
strategies incorporating training and support of
traditional birth attendants.
Disclaimer
The views and opinions expressed in the articles or
comments on this E-Group/Site are those of the
speakers or authors and do not necessarily reflect the
views and opinions held by Health Systems Research
India Initiative (HSRII). HSRII accepts no
responsibility or liability whatsoever with regard to
the content of the HSRII discussion forum.
Inappropriate content, product or service promotion,
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removed without notice and users may be banned. HSRII
maintains this e-group to enhance public access to
health systems research and our goal is to keep this
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to our attention, we will try to correct them.
-- SOUMIK BANERJEE
Sundarpahari,Godda
Jharkhand-814156
INDIA
Ph-0091- 9430168663, 09097624671
All That Is Not Given Is
Lost................................
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This message is only intended for the persons named in the TO and
CC: area of this email. Others who receive a copy need to confirm
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This is bound to happen as we increase our coverage of GM crops. Just to point out that it has already happened. Yesterday evening I was in a conference with agricultural scientists in an agricultural university of repute observing a debate on the GM issue. While I was happy to know that there was a division among them on this vital development, the arrogance and belligerence of the pro-GM group was frightening. They clearly told us that it does not matter that the FDA was not testing GM food crops for any kind of health effects. They told us it was perfectly ok for India to not have any kind
of laboratory to test GM crops. They said that Bt Cotton farmers committing suicide was not an issue with them. They said that we were obstructing the growth of science and that we had better be careful in the following days when GM multinationals would capture and dictate our agricultural policies, because our words would then be crushed by the huge power that these entities would possess. It was also ok for them that in the USA, and soon in India after the BRAI Bill was passed, the scientist's would be restricted from experimenting with these crops and no one could publish any studies without their permission. They also refused to listen to farmers who tried to say that their indigenous varieties had all the qualities that GM seeks to replicate and that these indigenous varieties should instead be researched upon. We really had no answers. It left us wondering on the kind of society that we are headed towards and the kind of people who would be ruling
us. In fact some of the mature scientists pointed out that perhaps the stone age was better than the world we are trying to build.
Regards,
Jagannath.
DHA used in infant formula products comes from genetically modified algae
(NaturalNews) One of the most vulnerable segments of the population -- infants -- are being affected as chemical giant
Martek Biosciences uses cronyism to have its patented GMO products classified as organic. The National Organic Program is trying to correct this, but in the meantime the "organic" infant formula or baby food parents feed their children could contain industrial Frankenfood.
History of Irresponsibility
The story of how this state of affairs came about reveals much on how politics and profit can undermine food safety. Here's a timeline on how the word "organic" is being undermined, creating a health threat for babies who are fed with formula.
2002: Food manufacturers begin supplementing infant formula and baby food with synthetic forms of docosahexaenoic acid (DHA) and arachidonic acid (ARA). These polyunsaturated omega-3 and omega-6 fatty acids, naturally present in breast milk, are important components of the human brain and eyes. Although the form of DHA/ARA used in infant formulas is structurally incompatible with the form found in human milk, food manufacturers market their products with the claim that their formulas will make babies more intelligent.
2006: In spite of the fact that its synthetic DHA/ARA is from laboratory-grown fermented algae and fungus through the use of hexane, a petroleum by-product and EPA-identified neurotoxin, Martek applies for organic status for its products. The USDA's National Organic Program (NOP) tells Martek its synthetic DHA and ARA does not quality as organic. Martek attorney J. Friedman ignores the decision of NOP staff and contacts NOP director Barbara Robinson to have the decision reversed.
2009: A front page Washington Post article, "Integrity of Federal 'Organic' Label Questioned" uncovers the Martek story. The article quotes Martek's lawyer
saying "I called Robinson up, I wrote an e-mail. It was a simple matter."
2002-2010: Parents and medical professionals observe reactions in babies fed with products containing Life's DHA, the product name Martek gives its patented GMO version of naturally occurring fatty acids. The range of infant health problems includes difficulties breathing and gastrointestinal disorders. When affected babies are no longer fed the formula, the ailments disappear. Although Freedom of Information Act requests reveal hundreds of FDA adverse event reports, the FDA is slow to react.
2011: FDA announces it will investigate claims that DHA/ARA infant formulas support brain and eye development. The National Organic Program is now trying to remedy its 2006 decision by asking Martek to formally ask permission of the NOP's National Organic Standards Board to use its DHA and AHA in organic products.
Products Containing this GMO
In the meantime, Life's DHA
is being sold in many so-called organic brands which many consumers trust. Paying higher prices for products labeled as organic does not necessarily mean your family's food does not include this particular Frankenfood. From Martek's own website, here is a list of infant formulas containing their product which is both genetically modified and typically manufactured using a known toxin:
Earth's Best Organic Soy with DHA & ARA (Hain Celestial Group)
Enfamil LIPIL (Mead Johnson Nutritionals)
Enfamil Next Step (Mead Johnson)
Isomil 2 Advance (Abbott Laboratories)
Nestle Good Start Supreme with DHA & ARA (Nestle USA)
There is also a long list of pre-natal supplements as well as vitamins and dietary supplements for infants, children and adults containing this product. A surprisingly wide range of foods and beverages use this GMO substance including Apple Bran Muffins sold at Starbucks; Farm Pride Omega-3 Eggs; Horizon Organic Milk; Kroger Active Lifestyle Premium Light OJ Beverage; Minute Maid Enhanced Pomegranate Blueberry Juice; Pediasure Children's Beverage; Pompeian OlivExtra Plus and Silk Soymilk. The list of products containing this GMO is multinational, with products in many countries across the
globe. If you want to check whether a supplement, food, or beverage you use contains Life's DHA, the full list is here:http://www.lifesdha.com/Products-Co...
(ActivistPost) – Why is cupric sulfate — a known herbicide, fungicide and pesticide — being used in infant formula? And why is it displayed proudly on product labels as a presumably nutritious ingredient?
Used to kill fungus, aquatic plants and roots of plants, parasitic infections in aquarium fish and snails, as well as algae and bacteria such as Escherichia coli, cupric sulfate hardly sounds fit for human consumption, much less for infants.
Indeed, infants are all too often looked at as “miniature adults” from the perspective of toxicological risk assessments, rather than what they are: disproportionately (if not exponentially) more susceptible to the adverse effects of environmental exposures. Instead of reducing or altogether eliminating avoidable infant chemical exposures (the precautionary principle), the chemical industry-friendly focus is always on determining “an acceptable level of harm” – as if there were such at thing!
It boggles the imagination how cupric sulfate ended up in infant formula, as well as scores of other consumer health products, such as Centrum and One-A-Day vitamins.
After all, it is classified, according to the Dangerous Substance Directive (one of the main European Union laws concerning chemical safety), as “Harmful (Xn), Irritant (Xi) and Dangerous for the environment (N).”
Moreover, the U.S. Environmental Protection Agency (EPA) requires that the warning signal “DANGER” appear on the labels of all copper sulfate end-products containing 99% active ingredient in crystalline form.
The Material Safety Data Sheet for Cupric Sulfate clearly states, in â€Section 3: Hazards Identification,” that it has the following adverse health effects:
Potential Acute Health Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of
inhalation.
Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. TERATROGENIC EFFECTS: Not available. DEVELOPMENT TOXICITY: Not available. The substance may be toxic to kidneys, liver. Repeated or prolonged exposure to the substance can produce target organs damage.
In â€Section 7: Handling and Storage” the following precautions must be taken:
Do not ingest. Do not breathe dust. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show t he container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as metals, alkalis.
Cleary we have a problem here. Cupric sulfate is used in most mass market infant formulas. Even
Similac’s “sensitive” formula contains the ingredient:
Could this be one reason why infant formula has been linked to over 50 adverse health effects, both short and long term, in infants given it in place of breast milk? The common explanation/claim is that infant formula isn’t intrinsically
harmful, rather, breast milk and breastfeeding is just healthier. I believe this perspective in untenable, given the problems with cupric sulfate, and dozens of other questionable ingredients being used in these products, such as petroleum-derived and chirally inverted dl-alpha tocopherol (synthetic vitamin E), zinc sulfate, sodium selenate, manganese sulfate, etc.
It is very true that still we are depending on TBAs and they are playing an important role in maternal health specially in the areas where home delivery is nearly 50% for various reasons.
While our focus is increasing in ensuring institutional deliveries and we are coming up with diffrent 'schemes' and incentive based programmes, I feel we are neglecting the safety of other half who in most of the cases are voiceless and can not reach institutions themselves. There is again question- how safe or equiped our institutions are really? In most of the cases there is no doctor or ANMs available, during nights pregnants are refused admission or have to depend on non-skilled support staff then why should they go to institutions? Is not it better for a would be mother to be in a known environment among own people- atleast it gives the would be mother a mental support!
Can you please take a lead or guide on how to build a strong advocacy on inclusion of TBAs and focus on their capacity building? It would be good for us who believe they are important to decrease maternal and child death and plan to work with them.
Thanks
urmi
From: Abhijit Das <abhijitchsj@...> To: reprohealth_india@yahoogroups.com Sent: Tuesday, 13 December 2011 12:05 AM Subject: [reprohealth_india] Trained TBAs - need to be kept within our programme purview [1 Attachment]
Dear Colleagues, Over the last few years that we have had the Janani Suraksha Yojana - we have had a dizzying rise in the rates of institutional delivery. However we have little evidence about the impact on maternal or infant well being. Instead at the last count in the Annual Health Survey showed maternal mortality rates are rising in many of the high focus states. The sample size of this study was even larger than the earlier studies. The JSY study report recently released by NHSRC shows that for the districts they studied the maternal mortality rate was 492 for deaths during delivery and post partum period ( pregnancy deaths were not counted). I am not arguing that maternal mortality is rising - all I am saying is that the reduction of maternal mortality is certainly not keeping pace with the extraordinary rise in institutional delivery. Also our capacity to save maternal lives - conduct C section or arrange for
blood transfusion has not increased concommitantly. ALSO - in many districts home births continue to happen for whatever reasons. Seeing the results of this review - presented below and the studies it refers to I feel that we need to continue with TBA training to support home deliveries where they are taking place. We also need to focus our attention on the emergency care linkage which saves lives during pregnancy, childbirth and post partum care rather than focus on bringing all possible cases to the 'institution'. I have earlier reported on how we saw bogus institutional deliveries recorded in Badwani district. Institutional delivery for 'ALL' is not a good policy solution in our context especially in the states of UP, Bihar, Orissa, MP, Rajasthan, Jharkhand, Chattisgarh, Assam - and we should without losing face re-start TBA training with effective referral linkage. The focus should be quick identification of complications - using
mobile phones for back up support if necessary and quick transportation to the nearest equipped facility. TBA training should be standardised to include standard set of skills including quick identification of complications. Please let us stop the ill considered push for universal (poor quality) institutional delivery - the evidence is not in its favour and let us not ignore the new evidence for continuing with TBAs especially where SBAs don't exist. We need to convince our decision makers at all levels. best wishes, Abhijit
Effectiveness of strategies incorporating training and support of traditional birth attendants on perinatal and maternal mortality: meta-analysis
Amie Wilson et al
BMJ 2011; 343:d7102 doi: 10.1136/bmj.d7102 (Published 1 December 2011)
Abstract
Objective: To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries.
Design Systematic review with meta-analysis.
Data sources Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were “birth attend*”, “traditional midwife”, “laybirth attendant”, “dais”, and “comadronas”.
Review methods: We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model.
Results: We identified six cluster randomised controlled trials (n=138549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonataldeath (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality(0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our
meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12;three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26).
Conclusion:Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants.
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Big B wants polio-free nation,
happy no polio case in 2011
New Delhi: 15th December 2011
Bollywood megastar and UNICEF goodwill
ambassador Amitabh Bachchan is happy with the drop in numbers of polio-affected
children in India and hopes that the country will get totally free from the disease. "For one whole year for the first time since I took
over the brand Ambassador of Polio UNICEF campaign, we have zero cases in
India. Feel proud and delighted that finally our efforts have been successful.
Started in 2002, with over 1000 cases and today just one in West Bengal," Amitabh posted on micro-blogging site
Twitter.
Activists slam device
claiming to curb female foeticide New
Delhi: 15th December 2011
Women rights activists and health experts
Thursday slammed a device claiming to curb cases of female foeticide by
recording sonography tests and monitoring doctors. 'Silent Observer', a device
attached to a sonography machine, records the name of every patient and carries
a photograph of her sonograms to deter those wanting to abort a girl child. A
password would ensure that the data would be accessible only to the government.
The Rajasthan Government
will soon construct a new trauma centre at the Suratgarh community health
centre in Sriganganagar district at a cost of Rs.1.92 crore to provide timely
medical care to victims of road accidents and patients brought in during
emergencies. State Medical and Health Minister Aimaduddin Ahmed Khan said
during his visit to Suratgarh that the trauma centre would have all modern
facilities and the latest gadgets for providing treatment to patients. He said
more doctors and paramedical personnel would be appointed to Government
hospitals.
All
government hospitals will have to renew their fire clearance certificates
within a month, said Delhi health minister A K Walia. He held a meeting on
fire-safety measures in government hospitals with officials and PWD engineers.
This comes in the wake of the blaze in AMRI in Kolkata that has claimed 93
lives so far.
India will be the only country in the world to screen its entire
125 crore population for prevention of cancer and some other non-communicable
diseases in the next five years, Health Minister Ghulam Nabi Azad told the
Rajya Sabha on Tuesday. Azad said that the government has already launched a
pilot project across 100 districts in 21 states for prevention and control of
cancer, cardio-vascular diseases, stroke, and diabetes.
After the neighbouring Bengal, it is now Jharkhand that has
planned public-private-partnership (PPP) venture for running government
hospitals in the State. The newly built 500-bed Sadar Hospital at Ranchi will
be the first such healthcare institution to be operated under the PPP mode, the
expression of interest would soon be out to rope in reputed group of the
country. Justifying the move, State Health Minister Hemlal Murmu said the State
Government had proposed to go for PPP mode for want of availability of
qualified and specialist doctors and trained nursing and paramedical staffs in
the State.
Delhi high court has directed the central and
state governments to chalk out a plan within two months to ensure that
vegetables and fruits are not treated with pesticides beyond the permissible
limit during farming. A bench of justices Sanjay Kishan Kaul and Rajiv
Shakdhar asked various government authorities to convene a meeting to come up
with a solution to the problem affecting the health of citizens. It also asked
them to identify the stage at which toxins make their way into the eatables.
Assam government will launch a complete health insurance scheme
for government employees from April next year. The new health scheme will
replace the health bonus system being offered currently approved under the
Sixth Pay Commission. The new scheme will cover all employees of the state
government and take care of their healthcare needs. Chief Minister Tarun
Gogoi announced this on Friday and said that the government would implement the
central health service scheme for the state government employees.
Delhi govt to give pension to HIV
patients, orphans
New Delhi: 1st December 2011
The Delhi government
plans to grant pensions to HIV patients, registered for treatment at Anti
Retroviral Therapy (ART) centres. Announcing the new policy on World AIDS Day,
Delhi Health minister Dr A K Walia said children who lost their parents to HIV
but are not infected by the virus themselves will also be covered under the
scheme. Later, Walia told Newsline, “We will process funds to grant a monthly
pension of Rs 1,000 for all HIV positive patients registered in ART centres,
and Rs 1,650 will be granted monthly to HIV positive children.”
From the abstract: “Hospital breastfeeding initiation rates (75%) show that most mothers in the United States want to breastfeed and are trying to do so. Even from the very start, however, mothers may not be getting the breastfeeding support they need. Low breastfeeding rates at 3, 6, and 12 months illustrate that women face multiple additional barriers to maintaining breastfeeding. What can we do to help more mothers be more successful?”
The UN Committee on the Rights of the Child has decided to elaborate a General Comment to the Convention on the Rights of the Child on the right to health of children under the age of 18. It is now calling for submissions from interested
organisations and individuals with extensive experience or information on this issue.
The Convention on the Rights of the Child (CRC) contains legally binding obligations in relation to the right of the child to health and health care (Art. 24). General Comments are meant to clarify the normative contents of specific rights provided for under the CRC or particular themes of relevance to the Convention, as well as offer guidance about practical measures of implementation. The General Comment on the right to health of children will clarify:
the normative content of the right of the child and adolescent to
enjoyment of the highest attainable standard of health, and to facilities for the treatment of illness and rehabilitation in relation to health care services; and
the legally binding obligations of States parties to the CRC with respect to ensuring the full realisation of the child’s right to health.
Questions
The submissions are invited to address the following questions:
What should be the basic premises for the
realisation of children's right to health?
How can the principles of the CRC, in particular articles 2, 3, 6 and 12, be applied to designing, implementing and monitoring interventions to address child and adolescent health challenges and what aspects are specific to a child's rights approach to health?
What is the normative content of article 24? What are the specific obligations of States under article 24? What are the responsibilities of non-state actors under article 24?
What are the priority concerns in general and in particular regions of the world for the implementation of article 24?
Which concrete measures should be put in place to implement article 24?
The submissions shall not address the content of Article 24.3, which will be covered by a
separate joint General Comment/Recommendation currently being produced by the CRC Committee in collaboration with the Committee on the Elimination of All Forms of Discrimination against Women (CEDAW).
How to submit
The CRC Committee welcomes inputs (maximum 5 pages) in English, French or Spanish. All submissions should be accompanied by a brief presentation (1 paragraph is sufficient) on the experience of the submitting individual or organisation in the subject matter.
Please send your submission to the following e-mail address in Word format before 7 January 2012: crc@....
The submissions received will subsequently be posted on a webpage dedicated to the General Comment. Please note that the United Nations does not offer remuneration of any kind for inputs into General Comments.
On 12/8/11, Jagannath Chatterjee <jagchat01@...> wrote:
> Why Is Pesticide Used As An Ingredient In Infant Formula?
> December 8th, 2011
> (ActivistPost) – Why is cupric sulfate — a known herbicide, fungicide and
> pesticide — being used in infant formula? And why is it displayed proudly on
> product labels as a presumably nutritious ingredient?
> Used to kill fungus, aquatic plants and roots of plants, parasitic
> infections in aquarium fish and snails, as well as algae and bacteria such
> as Escherichia coli, cupric sulfate hardly sounds fit for human consumption,
> much less for infants.
> Indeed, infants are all too often looked at as “miniature adults” from the
> perspective of toxicological risk assessments, rather than what they are:
> disproportionately (if not exponentially) more susceptible to the adverse
> effects of environmental exposures. Instead of reducing or altogether
> eliminating avoidable infant chemical exposures (the precautionary
> principle), the chemical industry-friendly focus is always on determining
> “an acceptable level of harm” – as if there were such at thing!
> It boggles the imagination how cupric sulfate ended up in infant formula, as
> well as scores of other consumer health products, such as Centrum and
> One-A-Day vitamins.
> After all, it is classified, according to the Dangerous Substance Directive
> (one of the main European Union laws concerning chemical safety), as
> “Harmful (Xn), Irritant (Xi) and Dangerous for the environment (N).”
> Moreover, the U.S. Environmental Protection Agency (EPA) requires that the
> warning signal “DANGER” appear on the labels of all copper sulfate
> end-products containing 99% active ingredient in crystalline form.
> The Material Safety Data Sheet for Cupric Sulfate clearly states, in
> ‘Section 3: Hazards Identification,” that it has the following adverse
> health effects:
> Potential Acute Health Effects: Hazardous in case of skin contact
> (irritant), of eye contact (irritant), of ingestion, of inhalation.
>>Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available.
>> MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. TERATROGENIC
>> EFFECTS: Not available. DEVELOPMENT TOXICITY: Not available. The substance
>> may be toxic to kidneys, liver. Repeated or prolonged exposure to the
>> substance can produce target organs damage.
> In ‘Section 7: Handling and Storage” the following precautions must be
> taken:
> Do not ingest. Do not breathe dust. Wear suitable protective clothing. In
> case of insufficient ventilation, wear suitable respiratory equipment. If
> ingested, seek medical advice immediately and show t he container or the
> label. Avoid contact with skin and eyes. Keep away from incompatibles such
> as metals, alkalis.
> Cleary we have a problem here. Cupric sulfate is used in most mass market
> infant formulas. Even Similac’s “sensitive” formula contains the ingredient:
> Could this be one reason why infant formula has been linked to over 50
> adverse health effects, both short and long term, in infants given it in
> place of breast milk? The common explanation/claim is that infant formula
> isn’t intrinsically harmful, rather, breast milk and breastfeeding is just
> healthier. I believe this perspective in untenable, given the problems with
> cupric sulfate, and dozens of other questionable ingredients being used in
> these products, such as petroleum-derived and chirally inverted dl-alpha
> tocopherol (synthetic vitamin E), zinc sulfate, sodium selenate, manganese
> sulfate, etc.
> For additional research on the inherent problems associated with the use of
> chemicals in infant formula, take a look at our evaluation of another
> Similac product
>
here:http://www.greenmedinfo.com/vitamin/similac-advance-early-shield-infant-for\
mula-iron
> Or, take a look at the “Organic” infant formula by Earth’s Best:, which is
> surprisingly not that much
> better http://www.greenmedinfo.com/vitamin/organic-infant-formula-dha-ara
> ________________________________
>
> Additional Research
> Cupric Sulfate – Pesticide Information Profile
> Cupric Sulfate – Toxicology Research on GreenMedInfo.com
> Blog: Infant Formula For Disaster
> Blog: Is Your Multivitamin Toxic?
> Please visit GreenMedInfo to access their vast database of articles and the
> latest information in natural health.
> Source: Activist Post
>
> ==================================================================
> Regional Centre for Development Cooperation
> A Not for Profit Institution
> A/68, First Floor, Sahidnagar
> Bhubaneswar - 751007
> Orissa, India.
> Phone: 0674-2545250
> http://www.facebook.com/jagannath.chatterjee
> http://www.facebook.com/pages/Information-on-Vaccine-Risks/211069518950053
>
http://pecangroup.org/educate-yourself/vaccination/50-reasons-not-to-vaccinate-i\
nfants
> Disclaimer: Views expressed in my mails are my own and may not represent
> that of the organisation.
> ===================================================================
>
--
Sent from my mobile device
The Lancet-UiO Commission: Global Governance for Health is an
independent academic research initiative managed in collaboration
with Harvard Global Health Institute.
The Commission was established as a result of deliberations between
Richard Horton, Editor of the Lancet, Dean Julio Frenk, Harvard
School of Public Health, Norwegian Minister of Foreign Affairs Jonas
Gahr Støre and Ole Petter Ottersen, Rector at the University of
Oslo.
Over the next two years, the Commission shall examine
aspects of governance, at both national and global levels, within
the health sector and in other sectors that impact health. The aim
is to go ‘beyond the consensus’ and propose recommendations on how
to solve controversial challenges related to effective protection
and promotion of public health in selected key policy-making
domains.
The new research and analysis to bear on these questions
will be published in an extensive report in The Lancet in August
2013 and the recommendations will also be presented at the United
Nations General Assembly in 2013.
The Commission consists of 16 renowned researchers and
policy-makers from across the world who contribute with valuable
insights from different fields of expertise and experience into
the work of the commission. Ole Petter Ottersen, rector at the
University of Oslo will be chairing the Commission throughout the
period. http://www.med.uio.no/helsam/english/research/global-governance-health/about/commission-members/
Hilary Standing, Kate
Hawkins, Elizabeth Mills, Sally Theobald, Chi-Chi UndieBMC
International Health and Human Rights2011,11(Suppl 3):S1 (16
December 2011)
Rose Oronje, Joanna
Crichton, Sally Theobald, Nana Lithur, Latifat IbisomiBMC
International Health and Human Rights2011,11(Suppl 3):S8 (16
December 2011)
--Publication of this supplement has been supported by funding from the UK Department for International Development (DFID) for the Research Programme Consortium on Realising Rights: Improving Sexual and
Reproductive Health in Poor and Vulnerable Populations. (Ms) Jashodhara Dasgupta
Coordinator
SAHAYOG
+91-9910203477
www.sahayogindia.org
When Arunachalam Muruganantham hit a wall in his research on creating a sanitary napkin for poor women, he decided to do what most men typically wouldn’t dream of. He wore one himself--for a whole week. Fashioning his own menstruating uterus by filling a bladder with goat’s blood, Muruganantham went about his life while wearing women’s underwear, occasionally squeezing the contraption to test out his latest iteration. It resulted in endless derision and almost destroyed his family. But no one is laughing at him anymore, as the sanitary napkin-making machine he went on to create is transforming the lives of rural women across India.
More details about Malaria deaths, Will Govt please listen?
Praful Chandel from Bilaspur says two days back on this platform I had informed about continuing malaria deaths in Bilaspur region of Chhattisgarh. Today I am giving you more details with name and
father’s name and village. But we see no action from the Government because all these people are poor and they live in remote areas. Will these deaths be just a statistics or will anyone listen? For more Praful
ji can be reached at 09575258495
THIRUVANANTHAPURAM: The state health department has decided to clear the controversy over the pentavalent vaccine scare in Kerala by seeking the help of an expert team to find out what led to the death of an infant on Thursday. The team comprising experts from the Unicef,World Health Organisation and Union health ministry will reach the state on Saturday to conduct the study. "The decision was taken following the allegation over the death of the infant linking it with pentavalent vaccine,'' health secretary Rajeev Sadanandan told TOI.
Following the allegation, a post-mortem was ordered by the district medical administration on Thursday itself. "The report is expected on Saturday,'' said Dr Peethambaran, district medical officer.
However, the health department has decided to have a comprehensive study into the impact of the immunisation drive which was launched in Kerala on December 14. A team led by Dr Pavana Murthy, regional coordinator, National Polio Surveillance Project, is expected to reach here on Saturday. "We
have asked top experts available in the country to reach Kerala for an impact study,'' said Rajeev Sadanandhan.
A 58-day-old baby born to Sabeer and Shajitha of Vithura was given the pentavalent vaccine at the Vithura Community Centre on Wednesday morning. The parents claimed that the infant developed fever in the night and was rushed to the hospital. The doctors said that it was a normal fever. But on Thursday, the baby was found unconscious and was rushed to the hospital where it was declared dead. tnn
Since the year 2006 I have been requesting the Health Ministry repeatedly to stop vaccinating children without doing the required research on vaccines. The only vaccine safety study is done by the vaccine manufacturers who generally do a 14 days safety trial and give a similar vaccine to the control group so that they can say, "there was no significant increase in risks when compared to the control group". Vaccine adverse effects do not usually happen immediately but may take 5 months to 5 years to manifest even in case of short term reactions. The adverse events can be death, very severe chronic illnesses or a lifetime of
disability. We are absolutely enraged at the way mass vaccinations are conducted in India with no full disclosure of side effects and without taking informed concent. Vaccines are an experiment on our children which violates the Nuremberg Code. They also violate the Precautionary Principle and various tenets of the Cochrane Collaboration. They also go against medical ethics and against the doctors oath of "First Do No Harm". Our children are treated worse than cattle as we are from a developing country. In developed countries billions are paid as compensation to vaccine damaged children but here all deaths and disability are termed as "coincidence" or "program errors". It is high time the vaccine policy makers are sent en masse to Tihar Jail. Nothing can exceed the corrupt practices of the world wide vaccine mafia who provide fodder to Big Pharma by spreading disease and disability. Today 1 in 6 Indian children suffer from developmental disorders, 8
crore Indian children suffer from autism, 3 crore suffer from various learning and behavioural disorders, 54.1% of our children suffer from chronic severe illnesses, 20% of our children suffer from various mental disorders and 45% of our children and youth suffer from neuro-psychiatric disorders. Our children are suffering from cancers, heart ailments, diabetes, and other non communicable diseases at a rate never seen before. Who is responsible for this catastrophic situation? Where is the disease free world that vaccines promised? If the new draft vaccine policy by Dr N K Ganguly in cohort with highly corrupt organisations like GAVI, PATH and BMGF is passed then our children will receive 70 toxic vaccine shots against the current 36 to 40. What will happen then? Over 300 vaccines are in various stages of development. So after they are developed children will receive 970 vaccine shots. What kind of a madness is this and when will it stop? Parents the
world over are spilling on to the streets to protest vaccines, often forced upon their children. This is in direct contravention to our Right to Life and Right to Freedom & Choice. Let our Government declare all the ingredients of vaccines, do both short term and long term research on individual and collective vaccines, compare that data with data from unvaccinated children, show it to the public and then let the public decide.
Vaccines: Analysing the Risk Vs Benefit Arguement - Jagannath
Chatterjee
When I started my
campaign, sometime in 1985, on the internet from 2001, doctors responded by
saying that vaccine safety was beyond question, they were as safe as water.
Later as I intensified my campaign and cited peer reviewed published material
on risks from vaccines, they modified their stance to; well all medications
have some risk. Now they fall back upon the risk-benefit analysis meaning that
the benefits outweigh the risks. Today I will touch on this topic in a
generalised fashion so that all can comprehend what I am trying to say.
I will start with the
human rights aspect. Human rights laws framed after World War II atrocities
cover not only medical research/interventions but also therapy. According to
them there should be full disclosure for all medical prescriptions and
procedures and that the subject has the choice to accept the risk or refuse,
that is the patient decides what is suitable for her or him. This is blatantly
violated by medical practitioners who feel that it is they who should take the
decisions. In case of informed consent on matters of vaccines, in developing
countries there is no disclosure though there is a hint in immunisation
procedure training manuals that healthworkers should inform parents that there
are risks involved which is not done. In case of developing countries there is
only token standardised leaflets that do not reveal the full story.
Doctors usually avoid
talking on the issue of informed consent. They will stare at you as if you are
an alien from another planet if you even broach the subject. But I have been a
little persistent. Indian doctors whom I have talked to/corresponded with say
that even hinting about a risk might prompt parents not to vaccinate their
children. This, according to them will severely compromise the vaccination
rates. This is a damning statement. So it seems vaccination targets are more
important than the life or health of the children. Parents deserve to know the
risks that their children face, whom they have conceived and nurtured for nine
months in their womb, on those their entire dreams and aspirantions rest, when
they are being administered vaccines, singly or in combination.
Now about the risks from
vaccines. I have pointed out again and again that vaccine risk is a taboo
subject that is always avoided, by manufacturers, policy makers and the medical
fraternity. When I complained to the WHO patient safety unit about what they
were doing to address the subject of ascertaining vaccine risks they replied
that the department is never allotted the required funds to do so. This is the
same with the FDA which licences most vaccines. GAVI & PATH did not even
feel the need to answer my queries on the subject. It has recently been
revealed that the FDA does not have the required cutting edge research
laboratory to conduct credible vaccine safety tests. In an article in
"Investigate Hers" - a family magazine from New Zealand, Merck
employees have complained that the vaccine safety team employed by Merck is not
adequately qualified and that Merck too has not appropriately upgraded its
laboratories. They said this was undermining the credibility of Merck, a
prominent vaccine MNC.
In case of vaccine
testing the onus is primarily on the manufacturer. The procedures followed are
highly questionable. The vaccines are tested on hand picked healthy children
while in real life vaccines are administered indiscriminately to vulnerable,
sick, underweight, preterm, immune compromised infants, a fact pointed out and
raised by senior pediatrician Dr T Jacob John in India. In these tests the
vaccinated children are compared to another group who are either vaccinated
with another similar vaccine, with other highly reactogenic vaccines or with
the vaccine ingredients minus the antigen. This is so the studies can safely
declare, "no significant changes were noticed in the vaccinated children
vis a vis control groups". The vaccinated children are observed for
usually for 14 days, as pointed out by Dr Sherri Tenpenny, or for that number
of days till the after effects start appearing. This is a skulduggery that is
an insult to the very procedure. Cases of deaths or very severe adverse effects
are often excluded citing that other extraneous factors were behind them. For
example, in the rotavirus vaccine clinical trial it was observed that the
vaccinated children suffered from respiratory tract infections. However this
was ignored as "the vaccine could not have possibly caused that". So
these trials are more about hiding vaccine risks rather than trying to identify
them.
There is a rule stating
that there should a monitoring mechanism after the vaccine is licenced and
released. However this mechanism is very tardy to say the least. There is
neither the political will nor the medical endeavour to ensure fair and
accurate monitoring. In case of the OPV, the IMA in India made the shocking
declaration that doctors were advised to ignore and not report cases of
paralysis caused by the vaccine. It goes to the credit of the then IMA chief
functionaries led by Dr S K Mittal that such a monitoring was done and it
revealed that on an average 500 to 600 cases of Vaccine Attributed Paralytic
Polio occur every year. The IMA also reported that the OPV was causing cases of
Acute Flaccid Paralysis (a condition indistinguishable from polio) to skyrocket
and that a vaccine strain virus had attained virulence and was circulating in
the population. While the IMA quoted a figure of 30,000 AFP cases, the JSA
reported 1,25,000 up to 2007 and The Telgraph science correspondent G S Mudur
indicated a figure of 3,00,000.
The IMA demanded
identification, treatment and rehabilitation of the tens of thousands of
victims of the Oral Polio Vaccine but the health ministry did not pay heed and
the matter was allowed to die down. I have reported recently how the cases of
intestinal intussusception (an extremely painful condition that may require
immediate surgery or lead to death) and intestinal bleeding in children
following the rotavirus vaccines are being observed but not reported because it
could "scare other doctors" and also hinder the process of including
this vaccine into the government schedule. The doctors are thus programmed not
to report vaccine adverse effects. They are not informed or taught about
serious vaccine risks in their textbooks or are told that serious events are
next to negligible. They are also not always knowledgeable about whom to report
and are often afraid to do so fearing reprisals from their associations. Only
deaths immediately following the vaccines which are brought to the notice of
the press ever get reported. But in almost 100% of the cases they are dubbed as
"coincidence" or blamed on "program errors" and the vaccine
is exonerated. Health care workers will not report vaccine adverse effects as
the entire blame is usually put on them and they are punished.
Vaccine adverse effects
do not occur immediately but may take weeks or months before manifesting as the
process is often slow and insidious though the end result may be catastrophic.
Doctors investigating vaccines say that even acute reactions may take from five
months to five years to manifest. Thus it becomes very easy to dissociate the
event from the vaccine and the cases end up by being termed idiopathic or
"cause unknown". Vaccine long term effects may span the lifetime
particularly as the inflammatory process set in motion does not stop. Many of
the vaccine ingredients lodge themselves permanently in the tissues, fat cells
and the brain and continue to inflict a steady and progressive damage
permanently. Attenuated live viruses introduced by vaccines may stay dormant
for long periods, often mutate, and can become virulent when the immune system
becomes weak due to any reason. As vaccines adversely affect the immune system
viruses and bacteria present in humans that were not virulent earlier are today
causing diseases, for example the Hib, which has coexisted since centuries with
humans without any averse effect, but which has become virulent and is now
causing meningitis and pneumonia in some immune compromised children and for
which yet another vaccine has been devised and is being forced upon the
population of mostly developing countries .
The other very dangerous
aspect involves animal and human genetic material contamination in vaccines.
Such contamination is inevitable, cannot be controlled, and cannot always be
traced as our knowledge about zoonotic (animal) viruses is very limited. Till
date, despite the intention not to identify the viruses, there have been traced
100 or so monkey viruses, bovine and avian leukemia viruses, porcine viruses,
cytomegaloviruses, the foamy virus and so on in vaccines. No research has been
done on their presence, continuation in the human body and mutation or their
incorporation into the human genome. SV 40, the Simian Virus, the only one
researched into for a short time before the researcher was ticked off and the
research stopped, is known to be behind many forms of tumours and cancers in
the human body. It is also known to be transmitted to the new generation as it
has contaminated the human sperm and most probably breast milk as well. Junk
DNA and RNA poses a graver threat as they can incorporate into the human genome
by a process known as reverse transcriptase. According to medical scientists
this form of threat is the most dangerous that vaccines pose but serious
concerns raised by medical scientists are being ignored.
Knowledgeable parents who do their own research genuinely
worry about vaccines because of many reasons;
1. The nature of vaccine ingredients that are highly toxic
in nature
2. How these toxins interact with themselves in a process
called synergistic toxicity is never studied
3. The child is given not one but many vaccines
4. Often the vaccines are administered
simultaneously
5. The safety aspects of such simultenous administrations
are rarely studied
6. The complaints of parents of adverse reactions
following vaccines go unheeded and they are often mocked at or threatened for
raising the subject
7. Parents today know that vaccine adverse effects may
take a long time to appear
8. Whether infants, a category with almost no liver
activity, with immature immune systems and low kidney efficacy can really
tolerate even one single vaccine shot. Studies in other mammalian species have
revealed that they cannot.
9. Vaccine shots have grown in number from 5 earlier to
70 shots of 16 different vaccines, up to 45 of them mandated in the United
States
10. Vaccine damage is extremely expensive to address and
families go bankrupt trying to take care of their children
11. Doctors do not understand autism and other
developmental disorders in children fully and they are programmed to treat them
as purely psychological and behavioral disorders of genetic origin. As a result
the parents have to research and treat their own children. Doctors who go
against the grain and try to biomedically treat these children are being
persecuted and branded as quacks.
12. The children suffer from lack of communication and so
cannot express their pain and discomfort. They cannot take care of themselves,
fall behind in their studies, rebel and run away, throw serious tantrums that
are difficult to control, suffer repetative behaviour patterns, and thus are
avoided by teachers and nannies and the burden entirely falls on the mother who
suffers endlesslly.
13. The presence of such a child in the family causes
familial tensions resulting in divorces and separation. There are cases of
mothers killing their own children and committing suicide unable to bear the
trauma.
14. Compensation is not given, or is extremely difficult
to obtain (only in developed countries is compensation even considered) as the
procedure goes against the interest of the victims and the scientific apparatus
have set conditions that almost negate any chance of compensation. There are
cases where the judges have understood the situation but have said that their
hands are tied, and have described vaccines as "unavoidably risky".
15. The parents cannot sue the vaccine manufacturers
because of an 1986 law passed by Parliamentarian Bill Frist and supported by
Ronald Reagan that indemnifies vaccine manufacturers from law suits.
16. Even then $ 2 billion has been compensated so far to
select cases, 83 of them for vaccine induced autism as per expert testimony of
those very officials who under oath admit to vaccine damage while negating them
otherwise.
17. Even then officials will not admit that vaccines
cause autism by offering the explanation that the court awards were for
"autism like symptoms' and not autism which is strange as autism is till
now a symptomatic disorder.
18. Recent law passed in California has waived parental
consent for vaccinating 12 year old children against sexually induced illness,
like vaccines for HPV and Hep-B. Other states threaten to follow suit.
19. All efforts are being made to mandate vaccines for
school and college admissions and parental exemptions are being made more and
more difficult to obtain.
20. There is a revolving door between health institutions
and vaccine manufacturers. Dr Julie Gerberding, Head of CDC who had steamrolled
many a call for enquiry into vaccine safety, today heads the vaccine division
of Merck. Dr Thomas Verstraeten of the CDC is today with GSK. Dr Paul Offit of
the Childrens Hospital of Philadelphia has joined the IOM, USA. Many health
officials and vaccine industry employees have joined the vaccine wing of the
Bill & Melinda Gates Foundation.
21. Vaccine decisions are often taken by politicians or
beurocrats who are influenced by money paid into election funds by vaccine
manufacturers.
22. Published studies on vaccine safety and efficacy are
conducted by doctors and scientists with conflicts of interest, which are often
not declared but later found out through public and activist investigations.
23. Medical journals have their functions conducted by
donations from the pharmaceutical industry which severely dilutes their
credibility.
24. Pro vaccine books wriiten by doctors and pro vaccine
articles or studies in journals are procured in bulk by vaccine manufacturers
which are then distributed free to doctors and policy makers involved with
vaccines to influence their opinion and to prove that vaccines are scientific.
25. Institutions who form vaccination schedules are
heavily financed by vaccine manufacturers and their office buildings built by
them or their annual events sponsored by vaccine manufacturers. Individual
doctors are also suitably rewarded in the guise of foreign fully paid jaunts
for continuing education or gifts to influence their decisions.
26. Latest genetic studies into origins of autism have
clearly stated that cases of genetic mutations have been observed which could
be due to external, termed environmental, toxines. The Joachim Hallmayer study
this September 2011 has doubted the theory being pushed that autism is
genetic.The Hallmayer study is the largest done so far conducted upon 900
twins.
27. It is a fact that pediatricians depend entirely on
vaccines and the resultant illnesses for their income. Unless this issue is
settled we are not going to see any perceivable shift in vaccine policy in the
near future.
So the overall picture
is that vaccine safety is not even low rung priority of any of the
stakeholders, except for the public for whom it is the one and only priority.
In India, I have had access to meeting records where vaccine policies are
discussed and I can declare that vaccine safety is not usually even touched
upon. The whole thrust is on introducing new vaccines and of ways to finance
the decisions. India's latest Draft National Immunisation Policy seeks to
sanction all vaccines available in the market, a move that has been strongly
opposed by doctors and policy makers who say that such a move is due to the
pressure from agencies like the Bill & Melinda Gates Foundation and the
international vaccine MNCs. A petition signed by doctors and medical scientists
has been submitted to the Health Ministry against this policy.
Vaccine effectiveness
has been questioned in published literature. According to a published study in
medpage, vaccine induced antibodies do not necessarily translate into immunity.
Today we know that humoral antibodies alone cannot prevent any disease and that
there are grey areas like cell mediated immunity, mucosal immunity, lymphatic
immunity and even organ specific immunity and there could be much more to it as
we know that even stress can affect immunity, factors not taken into
consideration while manufacturing vaccines. Cases of measles, whooping cough
and mumps outbreaks in fully vaccinated children have been reported in many
countries. Vaccine preventible disease outbreaks are blamed on non vaccinated
children without releasing key information about the disease outbreak in
vaccinated children. The herd immunity argument used to push vaccines into the
maximum number of children has been questioned as it is not based upon scientific
evaluation. Whereas countries such as Japan and Sweden concede cases of vaccine
adverse effects and pay compensation, those vaccines continue to be
administered in other countries. Vaccine batches rejected in developed
countries are not destroyed but shipped to developing countries. Currently a
large batch of a flu vaccine associated with risks is being considered to be
shipped elsewhere. Companies have reportedly even intentionally shipped
infected ingredients of vaccines so as to cause global outbreaks of diseases
mandating further vaccines (the Baxter incident).
Thus we are compelled to
come to the conclusion that the risk vs benefit anlaysis that the vaccine lobby
tom-toms to promote this highly controversial procedure is, to put it very
mildly and politely, seriously flawed.
All that I have
commented upon here has been published in various books, journals and is also
available on the internet. I have merely collated the information to create
awareness about vaccine risks. Parents are advised to do their own research
before deciding to vaccinate their children. Always remember, as stated by Dr
Ajay Gambhir of India, past Vice President of IAP, and a good friend of mine,
that you have a choice and that no one can infringe upon your rights to
forcefully vaccinate your child. If that is done please hire a lawyer, file a
case of assault in the police station in whose jurisdiction the area
falls against the doctor or institution involved and bring the matter to the
notice of the IMA, IAP or the Health Department (You can go to their websites
to get the contact numbers). There is no law in India mandating vaccines. The
government and also the IAP merely recommends vaccines and tries to pursuade
parents to vaccinate their children through the media and by employing
celebrities to send out the message.
The Ministry of Health and Family Welfare will
soon launch a Weekly Iron and Folic Supplementation (WIFS) programme. The programme, to be implemented across the
country, will cover nearly 12 crore adolescents. The Ministry has suggested to the States that
a fixed day in a week, preferably a Monday, be earmarked as the day when Iron
and Folic Acid tablet is provided to adolescents. Funding for implementation of the scheme to
the States would be provided under the National Rural Health Mission.
Chhattisgarh, which has poor health facilities in the interior
areas, is short of 1,846 doctors, the State Assembly was informed on Friday. "The
state has 187 hospitals where 2,030 doctors are posted but still the hospitals
are short of 1,846 doctors," Health Minister Amar Agrawal told the House
in a written reply, reports IANS. He said the Health Department had a massive
budget of around Rs 155 crore for the 2011-12 fiscal and the government was
striving to deploy doctors in all areas, even in remote pockets.
Rheumatic
heart disease (RHD) among Indian children could be 20 times more than what is
believed. A study conducted by the All India Institute of Medical Sciences
(AIIMS) in and around Delhi to see prevalence of RHD among children in northern
India found prevalence of 20.4/1000 school children as against 1 per 1000
children earlier believed.
With
around 7% of India’s population suffering from some form of mental disorder,
the health ministry is now focusing on increasing the country’s annual output of
qualified mental health professionals.Health
minister Ghulam Nabi Azad on Wednesday said India has only 23% of the required
psychiatrists and 25% of required psychiatric nurses. In view of this critical
shortage, the ministry, under the National MentalHealth
Programme, has allocated Rs 470 crore for manpower development through 11
Institutions of Excellence across the country, which will help produce 1,756
qualified mental health professionals annually, Azad said.
The medical and
health services across Rajasthan were affected for the second consecutive day
on Thursday due to ongoing strike by the doctors. The doctors have been
demanding pay parity with doctors at the Central Government hospitals. They
decided to stop work after talks with the Ashok Gehlot government collapsed.
‘Anti-sex selection Act unequal to curb
foeticide'
New
Delhi: 22nd December 2011
Of 61 cases filed
against medical practitioners in Delhi under the Pre-Conception and Pre-Natal
Diagnostic Techniques (Prohibition of Sex Selection) Act, 18 have been disposed
of without subjecting the doctors to any rigorous legal checks and scrutiny. “Disposal”
primarily meant the complainants withdrawing the cases. Sharing her perspective
at an interaction here on Wednesday, Bijaylakshmi Nanda, member of the State
Supervisory Board, attributed this weak response to improper implementation of
the law.
MP govt orders probe into drug tests on mentally ill
Indore:
21st December 2011
A day
after TOI exposed how government doctors in Indore subjected 233 mentally ill
patients to clinical trials to check the efficacy of various drugs, the Madhya
Pradesh health ministry has ordered a probe into the scandal. If was found that
42 of the patients were tested for Dapoxetine, a drug to cure premature
ejaculation.
The Crime
Branch has arrested a pharmacist of Ganga Ram Hospital and six others for
stealing drugs from the hospital and CGHS and selling them in the market. The arrested have been identified as Rajender
Chauhan, who is a pharmacist-cum-store keeper at Ganga Ram Hospital, Vivek
Singh alias Vicky (26), Vijay Ahuja, Atul Jain, Sachin Kumar, Hardeep Singh and
Satish Kathuria.
Calling communicable
diseases a "major public health challenge", Union Health Minister
Ghulam Nabi Azad on Wednesday said various socio-economic and environmental
reasons underlie the growing burden of communicable diseases. "Communicable
diseases pose a major public health challenge for India. The country is
vulnerable to emerging and re-emerging diseases because of the existing
environmental, socio-economic and demographic situation," Azad said
speaking at a meeting of the Health Ministry's Consultative Committee of
Parliament
Himachal Pradesh has included workers employed under Mahatma
Gandhi National Rural Employment Guarantee Act (MNREGA) and domestic servants
in the National Health Insurance Scheme. MNREGA workers, who got employment for
at least 15 days in a year, construction workers, the physically challenged
with 70 per cent disability, domestic servants and wayside vendors would be
eligible for the health insurance scheme by paying a premium of Rs 30, an
official statement quoting Chief Minister Prem Kumar Dhumal said.
Global health funding slows as
deadline for MDGs nears
New Delhi: 18th
December 2011
Developed
countries and funding agencies are putting the brakes on growth in development
assistance for health, raising the possibility that developing countries will
have an even harder time meeting the Millennium Development Goals deadline —
2015, according to new research from the Institute for Health Metrics and
Evaluation at the University of Washington. Even as aid continued to grow,
reaching $27.73 billion in 2011, significant cutbacks in the United States
slowed the growth rate in development assistance to 4 per cent between 2010 and
11 — the slowest in a decade.
40 medical institutions to be part of
govt health scheme
Pune: 16th
December 2011
With 40 hospitals
being roped in under the Central Government Health Scheme, more than one lakh
beneficiaries of the scheme in the city stand to benefit from the move. “While
28 hospitals and four diagnostic centres have been empanelled, another eight
hospitals have been shortlisted,” said additional director of CGHS Dr Eknath
Kanade.
Yet another reason to be worried. One of the first books I read about vaccines was the one "Vaccinosis & It's Cure by Thuja" by Dr J Compton Burnett a mainstream physician who converted to homeopathy. This book was written in 1884 signifying how early risks from
vaccines were noticed and studied. Vaccinosis is not very different from the miasm Sycosis in homeopathy (resulting from suppressed Gonorrhea). It is one of the prime miasms that answers how internal organs can be affected by disease. Actually it was the sudden prevalence of diseases involving internal organs which did not have a possible history that the homeopaths were hunting for a cause and Dr Burnett found it in vaccines. Sycosis is also the reason behind rheumatic arthritis which, as every physician knows, if mismanaged leads to damage of heart valves. I had to give this brief background for the news story that follows. I will urge all doctors in this list to go through books on classical homeopathy and classical ayurveda, as Prof Dr B M Hegde, Prof Dr M S Valiathan and many others have done. It is a sine qua non for converting oneself from a
doctor to a healer.
Regards,
Jagannath
Kids with rheumatic heart: Alarm bells ring
Kounteya Sinha TNN
http://epaper.timesofindia.com/Default/Scripting/ArticleWin.asp?From=Archive&Source=Page&Skin=TOINEW&BaseHref=CAP/2011/12/22&PageLabel=4&EntityId=Ar00400&ViewMode=HTML New Delhi: Rheumatic heart disease (RHD) among Indian children could be 20 times more than what is believed. A study conducted by the All India Institute of Medical Sciences (AIIMS) in and around Delhi to see prevalence of RHD among children in northern India found prevalence of 20.4/1000 school children as against
1 per 1000 children earlier believed. The study carried out echocardiographic screening of 6,270 randomly selected school children aged 5-15 years. RHD was twice as prevalent among children aged 11-15 years (prevalence of 26.5 per 1000 children) compared to children aged 5-10 years (12.6 per 1000 children). Girls had a higher prevalence of RHD (27.9/1000 girls) compared to boys (13.3/1000 boys). The study said though RHD was thought to be on the decline in India because of improving standards of living, the estimated prevalence of echocardiograpically detected RHD in India
was comparable to those measured in Mozambique (21.5 cases per 1000). The study was published in the British journal â€Heart’. Dr S Ramakrishnan from AIIMS’ department of cardiology told TOI, “Usually, doctors while carrying out a clinical examination listen to the child’s heart to check for abnormal rhythms or murmurs that may signify that the heart has been strained. Only when a murmur is detected is an echocardiographic screening done. Our study has now shown that the prevalence of RHD is several fold higher using echocardiographic screening compared with clinical examination (estimated less than 1 in 1000 children).” Dr Ramakrishnan added, “Though many believe that RHD in India is dipping,
we have now shown how rampant it could be.” Dr Anita Saxena from the same department and lead author said RHD can cause chronic heart valve damage which can eventually lead to heart failure. She said in case of an RHD, two valves of the heart among the four get affected. The mitrial valve is the commonest sufferer. The study also showed that thickening of the mitral and/or aortic valve was present in all cases. Of the 128 children, mild valve leakage was found in 101 children, and moderate valve leakage in 11
children. “Echocardiographic screening for RHD must be done more rigorously,” she said. The report said recent studies from Africa, using echoardiographic screening, had reported a nearly 10-fold higher prevalence of RHD in children. The prevalence of RHD among asymptomatic school children in India is not known. The suggested risk factors for RHD include overcrowding, poverty and unhygienic living conditions. “We carried out a large echocardiographic screening survey among asymptomatic school children living in rural areas of north India near Ballabhgarh – 40 km from AIIMS. The objectives of the study were to estimate the prevalence of clinical and subclinical RHD, to identify risk factors associated with RHD and to study the natural history of children with echocardiographically detected RHD,” the authors said. The study revealed older age, female gender, studying in government funded schoolsand overcrowding as significant predictors of RHD. FEVER HITS HEART Commonly, child
will have a very painful, swollen and red joint — usually large joint like a knee, ankle, elbow or shoulder HOW IT AFFECTS
HEART Rheumatic fever can cause Rheumatic heart disease. Can cause scarring of heart valves and also damages to aortic and mitral valves Rheumatic fever is a complication of strep throat infection, caused by streptococcal bacteria Symptoms appear two weeks after onset of untreated infection. Kids have sore throat fever, may be short of breath Most common in kids in 5-15 agegroup DIAGNOSIS Check for signs like joint pain & inflammation Check for abnormal rhythms/ murmurs that may signify straining of heartTREATMENT Antibiotics needed to treat strep infection Patients need to take penicillin to prevent recurrence
Older vaccines made from live or killed whole organisms were effective, but suffered from high reactogenicity. As vaccine manufacturers developed safer, less reactogenic
subunit vaccines, they found that with lower reactogenicity came reduced vaccine effectiveness. Somewhat ironically, the solution proposed to boost immunogenicity in modern vaccines is to add back immune-activating substances such as toll-like receptor agonists—the very same contaminants removed from old-style vaccines. This raises the question of whether the vaccine field is moving forward or backward. We propose that by avoiding adjuvants that work through toll-like receptor (TLR) pathways, and instead focusing on adjuvants stimulating B- and T-cell immunity directly, one can minimize inflammatory cytokine production and consequent reactogenicity. We present data on a polysaccharide-based adjuvant candidate, Advax, that enhances immunogenicity without reactogenicity, suggesting that potent and well-tolerated vaccines for both adult and pediatric use are indeed possible.
A major bottleneck in vaccine development is the lack of suitable adjuvants for adult and pediatric prophylactic vaccine use. Aluminum salts were introduced for human use in the 1930s when the regulatory environment was less stringent. The desire for new and improved adjuvants stems not only from the need to make existing inactivated vaccines more potent, but also to gain features such as antigen-sparing ability, more rapid seroprotection, stimulation of T-cell immunity, and longer-lasting protective immunity. Significant regulatory and other hurdles exist for developing new adjuvants, as evidenced by the complete absence of new FDA-approved adjuvants.
Safety and tolerability are critical regulatory issues confronting new adjuvants, and pose the greatest barrier to new adjuvant approvals. In addition to preclinical studies on the adjuvant itself, the combined antigen–adjuvant formulation must pass animal toxicology screens in at least two species at a dose and frequency similar to, or higher than, the proposed human dose, and using the same route of administration, to assess safety and tolerability before clinical tests can begin. Therefore, the benefits of incorporating any adjuvant into vaccines must be balanced against any increased reactogenicity or risk of adverse reactions. Unfortunately, in most cases, increased adjuvant potency is
associated with increased reactogenicity and toxicity. The best example of this is complete Freund's adjuvant (CFA). While it remains the gold standard in terms of adjuvant potency, its extreme reactogenicity and toxicity precludes its use in human vaccines, and there have been discussions of banning CFA even in veterinary vaccines.
Vaccine-caused adverse effects can be separated into two types: local and systemic reactions. Local reactions range from
injection site pain, inflammation, and swelling, to granulomas, sterile abscess formation, lymphadenopathy, and ulceration. Systemic vaccine reactions may include nausea, fever, adjuvant arthritis, uveitis, eosinophilia, allergic reactions, organ-specific toxicity, anaphylaxis, or immunotoxicity mediated by liberation of cytokines, immunosuppression, and induction of autoimmune diseases.1,2 While some systemic reactions such as allergy and anaphylaxis are clearly due to the antigen, others, such as adjuvant arthritis, may be caused directly by or exacerbated by the adjuvant. It can be difficult to identify which adverse reactions are mediated by the antigen, which by the adjuvant, and which by both.
Table 1. A range of human adjuvants under development with comparative features.
A major unsolved challenge in adjuvant development is how to achieve a potent adjuvant effect while avoiding reactogenicity or toxicity.3 Most newer human adjuvants including MF59,4 ISCOMS,5QS21,6 AS02,7 and AS048 have substantially higher local reactogenicity and systemic toxicity than alum. Even alum, despite being FDA-approved, has significant adverse effects including injection site pain, inflammation, and lymphadenopathy, and less commonly injection-site necrosis, granulomas, or sterile abscess.9 Although many adjuvant-caused vaccine reactions are not
life-threatening and do resolve over time, they remain one of the most important barriers to better community acceptance of routine prophylactic vaccination. This particularly applies to pediatric vaccination where prolonged distress in the child due to increased reactogenicity may lead directly to parental and community resistance to vaccination.10 Hence, particularly in the context of childhood prophylactic vaccines, it is critical that suitable adjuvants be developed with lower reactogenicity and greater safety. Ideally, in addition to being safe and well tolerated, adjuvants should promote an appropriate (humoral and/or cellular) immune response, have a long shelf-life, and should be stable, biodegradable, cheap to produce, and not induce immune responses against themselves.11 A brief description and history of potential human adjuvants follows (Table 1).
Aluminum Salts (Alum)
Mechanism of action. While the exact mechanism of action of aluminum adjuvants remains uncertain, proposed mechanisms include formation of a local antigen depot, efficient uptake of aluminum-adsorbed antigen particles by antigen-presenting cells due their particulate nature and optimal size, stimulation of immune-competent cells of the body through activation of complement, induction of eosinophilia, and activation of macrophages.12 Yet, none of these theories fail to adequately explain aluminum's adjuvant ability.
We propose an alternative unifying theory of aluminum action based on its toxicity. In our model, aluminum particles together with absorbed antigen are phagocytosed by tissue macrophages, which then become activated and mobilize into the lymph. Aluminum, once ingested, is toxic to cells13 and by the time they reach the draining lymph node most of the macrophages that have ingested aluminum particles will be dead or dying. Once necrotic, the macrophages release their cytoplasmic contents, including alum-absorbed antigen and inflammatory mediators such as IL-1 and TNF, into the lymph. This provides a source of macrophage cell debris, antigen, and co-stimulatory cytokines flowing into the draining lymph node, a potent mix to stimulate antigen-specific plasma cells and antibody
production. Interestingly, a similar mechanism was proposed many years ago to explain the adjuvant action of beryllium, a compound which is even more toxic to macrophages than aluminum, and has potent adjuvant activity.14
Limitations of alum. Although aluminum salts remain the most commonly used adjuvants and the only ones currently approved for use in humans by the FDA, they suffer from a number of downsides, including inability to induce cytotoxic
T-lymphocyte (CTL) responses critical in many cases for viral protection and clearance.15 Well-recognized problems of aluminum adjuvants include local injection site reactions, stimulation of eosinophilia, augmentation of IgE antibody responses, ineffectiveness for some antigens, and failure to enhance CTL responses. Alum is reasonably well tolerated when injected intramuscularly, with only mild to moderate injection pain and occasional granulomas. Risk of granulomas becomes particularly high when alum-based vaccines are injected subcutaneously or intradermally. Consequently, alum-containing vaccines are generally given by intramuscular injection.16,17
The mechanism for alum's tendency to stimulate eosinophilia and enhance IgE production is unknown, but its consequence is an increased risk of vaccine allergy and anaphylaxis.9,16,18,19 This potential has been demonstrated in animal models of ovalbumin-induced asthma or anaphlylaxis, which are dependent on alum in the initial priming. In humans, there have been reports of a chronic inflammation syndrome called macrophagic myofascitis (MMF) being induced by alum-based vaccines.20 The original description of the syndrome was based on a group of patients with presumptive diagnoses of myopathy mimicking polymyositis. Symptoms included myalgias, arthralgias, marked asthenia, muscle weakness, and fever. Abnormal
laboratory findings included elevated CK levels, increased ESR, and myopathic EMG, with muscle biopsies showing infiltration by sheets of macrophages with granular periodic-acid-Schiff positive content. The syndrome is due to the persistence of vaccine-derived aluminum at vaccine injection sites in the muscle, causing a chronic inflammatory reaction.21 Since its original description in 1993,22 more than 200 cases of MMF have been described in multiple countries.23 Neurological manifestations resembling multiple sclerosis have been reported in some patients.24 Children with MMF present with hypotonia and motor or psychomotor delay. A conclusive diagnosis is made by showing an aluminum peak in the lesion by energy-dispersive X-ray microanalysis. When Cynomolgus monkeys were immunized in the quadriceps muscle with diphtheria–tetanus vaccine, histopathological lesions similar to MMF in humans
were observed up to three and 12 months after aluminum phosphate and aluminum-hydroxide-adjuvanted vaccine administration, respectively.25 Aluminum is widely used as an adjuvant in human vaccines, and children can receive up to 3.75 mg of parenteral aluminum during the first six months of life. Intraperitoneal injection of aluminum-adsorbed vaccines in mice causes a transient rise in brain tissue aluminum levels peaking around day. 2–3 It is likely that aluminum is transported to the brain by the iron-binding protein transferrin and enters the brain via specific transferrin receptors.26 Of major concern is the finding in cats of feline fibrosarcomas at the site of aluminum-adjuvanted vaccination. The tumors are sometimes surrounded by lymphocytes and macrophages that have taken up aluminum (with lesions identical to MMF), leading to the hypothesis that persistent inflammatory and immunological
reactions associated with aluminum derange fibrous connective tissue repair responses, leading to neoplasia.27
Oil-in-Water Emulsions
General mechanism of action. Oil-in-water emulsions include Montanide, Adjuvant 65, and Lipovant.28 (MF59, also an oil-in-water emulsion, is discussed separately below.) Oil-in-water particles are irritants and cause local inflammation, inducing a chemotactic signal that elicits local macrophage invasion. The oil particles, along with associated antigen, are rapidly ingested by macrophages, which traffic to the draining lymph node. Because of frequent adverse reactions, the major human use of oil-in-water emulsions has been in therapeutic cancer and HIV vaccines29although Adjuvant 65 was previously used in a prophylactic influenza vaccine. Montanide adjuvants are variously formulated as water in
oil, oil-in-water, or water in oil-in-water emulsions.30,31 The water-in-mineral-oil adjuvant Drakeol/ISA-51 has been used in HIV-infected individuals.32 Water-in-squalene emulsion (ISA-720) has been evaluated in a malaria vaccine trial.31 Although potent, such adjuvants induced severe local reactions in some recipients.33,34 Emulsions have also been used as delivery systems for immunostimulatory adjuvants, including MPL and QS21. An oil-in-water emulsion containing MPL and QS21 (SBAS-2) induced protection in a mouse model of malaria equivalent to that seen with CFA35 and was subsequently shown to confer short-lived protection in a malaria challenge in human volunteers, though with a high reactogenicity profile.36 In trials with a HIV vaccine, SBAS-2 induced high antibody titers and proliferative but not CTL responses.37
Limitations of oil-in-water emulsions. Use of oil-in-water emulsions has been limited by their reactogenicity and potential for adverse reactions. Various types of emulsions have been used, with different natural oils, in order to try to find more stable, potent, less reactogenic formulations.38However, they still suffer from excessive reactogenicity and toxicity which restricts their suitability for prophylactic vaccines, particularly those intended for children.
MF59
Mechanism of action. Originally, Syntex adjuvant (containing squalene oil, a non-ionic surfactant, poloxamer L121, and threonyl muramyl dipeptide) was developed as a replacement for CFA.39However, this adjuvant proved too toxic for human use40 and Chiron subsequently developed MF59 adjuvant as an alternative.41 MF59 is a submicron oil-in-water emulsion which contains 4–5% w/v squalene, 0.5% w/v Tween 80, 0.5% Span 85, and optionally, varying amounts of muramyl tripeptide phosphatidyl-ethanolamine (MTP-PE), which activates non-TLR sensing receptors known as NOD-LRRs (reviewed in Akira42 ). Because of excessive reactogenicity and/or toxicity, the current version of MF59 used in an adjuvanted influenza vaccine (FLUAD) registered in Italy does not contain MTP but instead just squalene oil and
surfactants.43,44 Published data suggests addition of MF59 only induces a modest (about 25%) increase in antibody levels in the elderly and no difference in younger individuals when compared to unadjuvanted influenza vaccine.4,45 Furthermore, there was little evidence that MF59 is antigen-sparing for influenza vaccines, since the same antigen dose is required for MF59 as for the unadjuvanted vaccine.4,45 MF59 has been shown to be superior to alum in inducing antibody responses to hepatitis B vaccine in baboons46 and humans.47
Limitations of MF59. On the negative side, MF59, like all other oil-in-water adjuvants, is associated with major increases in injection site pain and reactogenicity.4 Another concern with squalene oil is its ability to induce chronic inflammatory arthritis in susceptible animal models.48 Susceptibility to squalene arthritis is genetically determined, raising the risk that adjuvants based on squalene oil may also induce or exacerbate inflammatory arthritis in genetically susceptible humans.48
Monophosphoryl Lipid A (MPL)
Mechanism of action. Bacteria-derived immunostimulants constitute a major potential source of adjuvants. Lipopolysaccharide
(LPS),49 containing the active Lipid A moiety, is very potent but too toxic for human use. MPL is a chemically detoxified derivative of native Lipid A from Salmonella minnesota R595, which is used in complex adjuvant formulations with alum, QS21, liposomes, and emulsions, and is a component of GlaxoSmithKline's proprietary AS02 and AS04 adjuvants.7,8,50Like LPS, MPL interacts with TLR4 on macrophages, resulting in the release of proinflammatory cytokines including TNF, IL-2 and IFN-gamma, which promote the generation of Th1 responses.51,52MPL has been extensively evaluated in human subjects for applications including vaccines for cancer and infectious disease (genital herpes, HBV, malaria, and HPV), and allergies. Approved vaccines containing MPL include a melanoma vaccine approved in Canada, a hepatitis B vaccine for hemodialysis patients approved in Europe, and an HPV vaccine approved
in Australia.
Limitations of MPL. Although MPL lacks some of the more extreme toxicities of LPS, it is nevertheless able to strongly activate via TLR-4, inducing pro-inflammatory cytokines, and thereby significant reactogenicity. In terms of production, like any bacterially-derived material, there are issues of consistency of preparation, formulation, and cost.
CpG
Mechanism of
action. The immunostimulatory effect of bacterial DNA is due to the presence of unmethylated CpG dinucleotides which are both rare and methylated in vertebrate DNA.53–55 CpG's effect is mediated by endocytic TLR9 receptors56 expressed on B cells and plasmacytoid dendritic cells in humans, triggering the release of inflammatory cytokines57 and biasing responses towards Th1 immunity and induction of CTL.58 CPG 7909, developed by Coley Pharmaceuticals, has been tested in conjunction with an alum-adjuvanted Hepatitis B vaccine. This vaccine resulted in faster achievement of protective antibody levels and higher overall titer. There was an indication of enhanced CD8 CTL responses, but only in higher CpG dose groups.59 In Phase 2 cancer trials using a CpG adjuvanted Melan-A vaccine in melanoma patients, there was evidence of induction of CD8 CTL's specific for Melan-A
expressed by tumor cells, but little effect on outcome.60
Limitations of CpG. In human trials of CpG adjuvants, adverse events included injection site reactions, flu-like symptoms, and headache, and were all more frequent in CpG versus alum adjuvanted groups.59 This is due to TLR9 activating NK-kB, a major inducer of inflammatory cytokines such as TNF-alpha, which are largely responsible for reactogenicity of adjuvants using TLR
pathways.61–63 Overall, reactogenicity, toxicity, and safety remain a barrier to acceptance of CpG adjuvants for human prophylactic vaccines. Additionally, TLR9 signalling has shown to play a critical role in experimental allergic encephalitis (EAE), a model of human multiple sclerosis,64 and can even break tolerance and trigger EAE in otherwise healthy animals,65 raising concern that CpG adjuvants could induce or exacerbate multiple sclerosis or other autoimmune diseases in susceptible individuals. Activation by CpG-DNA also has been shown to trigger and exacerbate systemic lupus erythematosus (SLE), with TLR9 activation in genetically prone mice triggering lupus nephritis.66CpG-DNA triggers lupus nephritis due to its potent immunostimulatory effects at multiple levels, including B-cell IL12p40 production, B-cell proliferation, double-stranded DNA autoantibody secretion, and dendritic cell
IFN-alpha production.67
QS21
Mechanism of action. QS21 is derived from Quil A, itself a collection of triterpenoid glycosides (saponins) derived from the bark of the South American soap bark tree, Quillaja saponaria. QS21 induces Th1 cytokines and antibodies of the IgG2a isotype in mice, consistent with a Th1 bias.68–70Saponins integrate into cell membranes through interaction with cholesterol, resulting in pores71through which antigens enter. Subsequently, peptides from these antigens may be processed and presented via MHC class I, stimulating a CD8 CTL response. Numerous clinical trials have been conducted using QS21 in cancer vaccines and infectious disease, including HIV-1, influenza, herpes, malaria, and hepatitis B.72 The saponins have also been used in adjuvant formulations such as
immunostimulatory complexes (ISCOMs) which will be discussed separately.
Limitations of QS21. Severe injection site pain is a major limiting factor in QS21 use. In addition to pain on injection and granulomas, toxicity of QS21 includes severe hemolysis,3,6,69,73,74 making such adjuvants unsuitable for human prophylactic uses. This was highlighted in a recent trial of a QS21 adjuvanted influenza vaccine in healthy young adults where vaccination site
pain and postvaccination myalgias were far greater in the QS21 group, and the QS21-containing vaccine had no advantage in terms of antibody response compared with the unadjuvanted vaccine.75 In a trial of QS21 in a cancer vaccine, virtually all of the patients experienced inflammation and/or pruritis at the site of injection attributed to the QS21 adjuvant.76 Other common side effects were fever (71%), fatigue (44%), flu-like symptoms (58%), chills (29%), myalgias (48%), and headache (66%). These toxicities were thought by the investigators to be all due to QS21, given there was no correlation between vaccine dose and toxicity.77
In a trial of a malaria vaccine using QS21, two of 89 individuals developed severe vaccine allergy, a high complication rate for a prophylactic vaccine.78 Further issues of QS21 safety have also surfaced with deaths of human subjects in an Alzheimer's disease vaccine trial using QS21, although the contribution of QS21 to these encephalitis deaths is not clear.79
ISCOMs
Mechanism of action. ISCOMs are immunostimulating complexes containing a saponin, a sterol, and, optionally, a phospholipid. The preferred saponins are Quil A or QS21, the preferred sterol cholesterol, and the phospholipid is generally
phosphatidylethanolamine. ISCOMs have been shown to help generate protective immunity in a variety of experimental models, and generate CTL responses to such antigens as HIV envelope glycoprotein and influenza hemagglutinin.80,81 The principal advantage of ISCOMs is to reduce the dose of the highly toxic QS21 adjuvant component (the saponin component is bound to cholesterol and is less free to interact with cell membranes, thereby reducing QS21 hemolytic activity.)82,83 ISCOMs, being particles, are also more likely to be phagocytosed directly by macrophages. The adjuvant activity of ISCOMs is related to their ability to induce cytokines, including IFN-g and IL-12,5,84 consistent with an ability to skew immune responses in a Th1 direction.
Limitations of ISCOMs. ISCOMs have suffered from issues including cost, manufacturing difficulty, and stability, in addition to reactogenicity, toxicity, and safety concerns.6,85 Side effects in a Phase 1 human cancer trial included flu-like symptoms, fever, and malaise.86 A major part of ISCOM reactogenicity and toxicity reflects the inclusion of Quil A or QS21 as an active ingredient. Hence all safety concerns about QS21 apply to ISCOMs.
Liposomes
Mechanism of action. Liposomes are synthetic phospholipid
spheres consisting of lipid layers that can encapsulate antigens and act as both vaccine delivery vehicle and adjuvant.87 The adjuvanticity of liposomes depends on the number of lipid layers,88 electric charge,89 composition,90 and method of preparation.90-92 Their use enhances both humoral and cell-mediated immunity to protein and polysaccharide antigens.89,91 Liposome-based vaccines based on virosomes are approved in Europe for hepatitis A and influenza.93 They have been shown to better induce CTL to influenza in elderly humans compared to unadjuvanted vaccine.94 INFLUSOME-VAC, which contains IL2-supplemented trivalent liposomal influenza vaccine, showed enhanced immunogenicity when compared with standard split-virion vaccine in elderly and young subjects, but at the expense of an overwhelming (83%) incidence of pain at the
injection site.95 The mechanism of liposomes is fusion with the cell membranes of macrophages, enabling delivery of proteins into the cytoplasm where they can enter the MHC class I pathway and activate CD8 CTLs.96,97 Liposomes can be made with various charge properties and cationic lipid vesicles comprising cationic cholesterol derivatives, and optionally neutral phospholipids98 are able to bind antigen on the surface and thereby enhance antigen presentation. Modified proteo-liposomal structures termed cochleates have also shown utility as systemic adjuvants.99
Limitations of liposomes . Liposomes have suffered from manufacturing difficulties, stability, and high cost, which have limited their use. Furthermore, they are more antigen vehicles than true adjuvants and hence require addition of immunostimulatory components such as MPL for potent adjuvant action. Injection site pain can be a major limitation in some liposome vaccines.
Advax
Mechanism of action. Nanocrystalline particles of inulin, a natural plant-derived polysaccharide consisting of a linear chain of fructose molecules capped by a single glucose, are the active constituent of Advax. A relatively hydrophobic backbone structure gives inulin unique physicochemical properties: it
can be crystallized into a number of different isoforms.100 Specific isoforms of inulin have the unique ability to enhance antigen-specific humoral and cellular immune responses without reactogenicity.101–103 Another advantage of Advax is that inulin can be prepared in exceptionally pure form, free of endotoxin or other contaminants, is heat stable with an extremely long shelf-life, and has had no safety issues over many decades of human use in intravenous injections for renal function testing (British Pharmacopoeia). Inulin is not metabolized in humans but is excreted unchanged in the urine as fructose and a small quantity of glucose. Advax's excellent safety and tolerability make it well suited to inclusion in childhood as well as adult vaccines.
Limitations of Advax. Currently, one of the main obstacles facing Advax is the presumption within the vaccine community that adjuvant potency is proportionate to inflammation and reactogenicity.104–110 This dogma has arisen from uncritical acceptance of the "danger" hypothesis, which suggests that immunogenicity is linked to activation of the innate immune system. Advax gives good humoral and cell mediated immune responses in the absence of inflammation100–103,111–114or reactogenicity, thereby refuting the idea that "danger" signals are essential to eliciting potent adaptive immune
responses.
Summary
This paper highlights that the major differences between current adjuvants is not their efficacy, but their reactogenicity and safety. Increased reactogenicity reflects either an adjuvant's intrinsic tissue irritant effect, e.g., for MF59 and other oil emulsions or QS21, or its ability to induce inflammatory cytokines, e.g., LPS or MPL (through TLR activation). While alum has a modest tissue irritant effect, it does not directly induce inflammatory cytokine production, thereby explaining its lower reactogenicity.
Advax polysaccharide adjuvant has no local tissue irritant effects and does not induce cytokine production in vitro, explaining its almost complete lack of reactogenicity, which is unique among the known adjuvants. Adjuvant potency must be balanced against potential to do harm. Microbial cell components and TLR agonists including MDP, LPS, trehalosedimycolate, and beta glucan, and also oils such as pristane and squalene, are potent inducers of inflammatory arthritis in arthritis-prone animal strains. Since rheumatoid arthritis affects 1% of the population, there is significant risk of exacerbating or inducing such autoimmune syndromes in humans. Similarly, TLR agonists such as CpG have been shown to induce and exacerbate EAE and lupus. The ability of TLR agonists to break immune tolerance,
potentially leading to autoimmunity in susceptible individuals, may preclude their inclusion in prophylactic vaccines, particularly for children.
Similarly, the severe reactogenicity of compounds such as QS21 and oil emulsions preclude their inclusion in prophylactic vaccines. They may have restricted use in applications such as vaccine treatment of life-threatening conditions such as cancer and HIV. Although alum is the current gold standard and has a favorable reactogenicity
profile compared to other adjuvants, major long-term safety issues continue to cloud its future, with concerns including MMF and vaccine allergy.
Liposome technology is highly promising and appears to offer significant advantages, providing reactogenicity is not excessive and sufficient immunogenicity is obtained. Currently, Advax is the only adjuvant that is non-reactogenic and without safety concerns in pre-clinical and clinical trials. This profile makes it ideal for
inclusion in prophylactic vaccines, including those intended for use in children where maximum safety and tolerability are paramount.
This article demonstrates the relative under-development of the science of adjuvants, compared with the rapidly advancing knowledge of vaccine antigens. It is extraordinary that the exact mechanism of action remains unknown for many adjuvants, including alum, the oldest known vaccine adjuvant. Given the increasing importance of adjuvants to
modern vaccines, national and international funding agencies urgently need to institute policies to address this imbalance and provide major new support for adjuvant basic science and clinical development.
Nikolai Petrovsky is affiliated with the Department of Endocrinology and Diabetes at Flinders Medical Centre, the Department of Medicine at Flinders University, the Child Health Research Institute, and Vaxine Pty Ltd., all in Adelaide, South
Australia. Susanne Heinzel is affiliated with the School of Pharmaceutical, Molecular, and Biomedical Sciences at the University of South Australia, and with Vaxine Pty. Ltd. Yoshikazu Honda is with Vaxine Pty. Ltd. A. Bruce Lyons is a member of the Department of Medicine at Flinders University, the School of Pharmaceutical, Molecular and Biomedical Sciences at the University of South Australia, the Department of Medicine at the University of Adelaide, Vaxine Pty., Ltd., and the Hanson Institute, all located in Adelaide, South Australia.
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The Biotechnology Regulatory Authority of India Bill, if passed, will adversely affect agriculture, health of humans and animals, and the environment, causing unparalleled harm.
It is now widely accepted that the existing procedure in India (and even elsewhere) for regulation of genetic engineering
technology is faulty and insufficient. It was for this reason that Jairam Ramesh, then Minister for Environment and Forests, put an indefinite moratorium on the open release of genetically engineered Bt brinjal, which was approved by the Genetic Engineering Approval Committee of the Ministry on October 14, 2009.
The Biotechnology Regulatory Authority of India (BRAI) Bill, proposed to be put up to Parliament, claims to take care of the deficiencies in the existing system of approval of genetically modified (GM) crops. As it turns out, the Bill is unconstitutional, unethical, unscientific, self-contradictory, and not people-oriented. It suffers from greater flaws and deficiencies than the present system.
If passed, it will seriously and adversely affect agriculture, health of humans and animals, and the environment, causing unparalleled harm.
BRAI will consist of three full-time and two part-time members. It will have three divisions, each headed by a Chief Regulatory Officer. It will be supported by a Risk Assessment Unit, an Enforcement Unit, a Monitoring Office, a Product Ruling Committee, an Environmental Appraisal Panel, Scientific Advisory Panels, an Inter-ministerial Governing Board, a Biotechnology Advisory Council, and State Biotechnology Regulatory Advisory Committees. These bodies would consist mostly of bureaucrats who are likely to have little knowledge of the highly complex issues that
arise in today's biotechnology. No civil society participation is proposed anywhere. Even the proposed Biotechnology Regulatory Appellate Tribunal will not accept complaints from civil society, in spite of the fact that the Bill directly or indirectly affects every citizen. It is not even clear which department of the Government of India will service BRAI. The Convener of the Selection Committee for members of BRAI will be from the Department of Biotechnology (DBT), which is a vendor of genetic engineering (the technology that BRAI is supposed to regulate) in the country. The Bill says the members of BRAI will be persons of integrity. There is, however, no requirement of integrity for members of any of the other committees mentioned above!
The Bill is unconstitutional as agriculture is a State subject, and it takes away from the State government the authority to take decisions on GM plant products. In this connection, it is noteworthy that more than 10 States cutting across political affiliations formally told Mr. Ramesh in 2009-2010 that they would not permit Bt brinjal to be released in their territories.
No public consultation
Article 28 of the Bill states the information declared by BRAI “confidential commercial information” will not come under the RTI Act, and there is no way civil society can challenge its decision to declare any information confidential. In spite of the fact that BRAI encompasses activities that would virtually affect every Indian, there is no mention in the Bill of public consultation.
Articles 81, 86 and 87.2, which allow BRAI to override any existing law in the areas covered by BRAI, contradict Article 86, which says “the provisions [of BRAI] shall be in addition to, and not in derogation of, any other law for the time being in
force.”
The definition of modern biotechnology in Article 3 (r) is absurd as it excludes a large number (over 25) of areas such as peptide synthesis, immuno-technology, tissue culture, stem cells and nano-biotechnology that are an integral part of today's biotechnology. Not only that, it would make techniques that are used in everyday research in modern biology such as isolation or sequencing of DNA and the PCR technique illegal, unless approved by BRAI in every specific case. So every university in the country teaching these extremely widely used techniques will have to get BRAI permission for teaching them to undergraduate and postgraduate students.
Funnier is the inclusion in Schedule I (which lists organisms and products “which should be regulated by the Authority”) of cloned animals, DNA vaccines, and stem cell-based products. There is no mention of them in the main text of the Bill. Schedule 1 also includes “products of synthetic biology for human or animal use.” I have been in the business of modern biology for six decades and seen the modern biological evolution from very close quarters with more than 20 of my friends having won Nobel prizes but, for the life of me, I cannot make out what is meant by “products of synthetic biology.”
In fact, if one strictly followed item 2(d) of Schedule 1, no organ transplantation would be possible in the country without BRAI permission!
One would also have expected that the Bill, if it was people-oriented, to state the procedure to be adopted before approval of a GM product. The first step should be to determine the need for the product through a socio-economic survey and analysis. If there is need, then one should determine if there are cheaper, better and well-established alternatives such as smart or molecular breeding, organic agriculture, or use of Integrated Pest Management or
bio-pesticides in the case of GM products containing a foreign pesticidal gene. If it is concluded that there is no alternative to, say, a GM crop, one would need to state a mechanism for deciding what tests the GM crop would need to undergo, and a statement of who will do the tests to ensure public credibility. There is no provision in the Bill for an independent testing laboratory for GM crops, in which civil society would have confidence.
No mention of mandatory labelling
There is no mention of mandatory labelling of GM food products, and there is no protection provided to, say, farmers whose fields growing, for example products of organic agriculture, get contaminated with a GM product of the neighbouring farm.
Article 62 under “Offences and Penalties” is unprecedented. It implies that anyone making a statement about a GM crop which BRAI decides is false or misleading, shall be punished with imprisonment for a term which may extend up to three months and also with a fine which may extend to Rs. 5 lakh. BRAI will not be obliged to state the basis of its
decision which is not challengeable by any member of civil society. The Bill thus assumes that all the wisdom of biotechnology lies with the five members of the Authority, and what thousands of leading scientists say will cut no ice with the members of BRAI.
One may justifiably ask why this Bill. The reasons are clear. Food business is the biggest in the world. Whosoever controls it will control the world. To control food production, one needs to control just seed and agrochemicals production. This is what a handful of multinational seed companies, which are also producers of agrochemicals such as pesticides and weedicides, are attempting to do through patented GM crops. These companies are located in
the United States, and liaise closely with the U.S. government.
In fact, one of the biggest quarrels between the U.S. and Europe is that Europe, by and large, does not allow GM crops and requires appropriate labelling of all food products that contain more than 0.9 per cent of GM material. No such labelling is required in the U.S. where, therefore, a person today does not know if he is consuming GM food.
Till a few years ago, there was no significant
opposition to GM crops in India. In fact, the mechanism set up by the Government of India, ostensibly to regulate GM products, largely worked as a vendor of GM products, serving the interests of seed and agrochemical MNCs.
But, then, people of India became wiser and better-informed. Consequently, against all odds and expectations of the MNCs, and of the U.S. government and the rulers in India, we had an indefinite moratorium on Bt brinjal, and the opposition to GM crops became a force to reckon with. Some components of the existing regulatory system have also begun to assert themselves. As of today, at least five States (Bihar, Madhya Pradesh, Kerala, Karnataka and Himachal Pradesh) have formally
declared that they will not allow field trials and/or open release of any GM crop. So, the present system had to be disabled, and roadblocks to fulfilling the ambition of the U.S. and the seed MNCs removed. What better way to achieve this than by BRAI — so the government thought. But, I believe, the GoI has again underestimated the collective wisdom of the people of India!
(Pushpa M. Bhargava is former Vice-Chairman, National Knowledge Commission.)
THERE IS a battle that is described in court papers as Soni Sori vs the State of Chhattisgarh. Sori, 35, is a schoolteacher from Jabeli, accused of supporting the banned CPI(Maoist). She denies all the charges.
In September, she was fired upon in the jungles of Chhattisgarh. Fearing for her life, she fled to New Delhi. On 7 October, she was arrested and sent back to Chhattisgarh. When she pleaded with a Delhi magistrate to keep her in the capital, he had said, “Not all police are bad.”
Those following Sori’s story understand why this is not her battle alone. Last month, hearing a PIL filed by Sori’s lawyers, which alleges she was tortured in police custody, the Supreme Court (SC) ordered a Kolkata hospital to conduct an independent medical exam. The report by NRS Medical College has confirmed the allegations. It describes two stones recovered from her vagina and one from her rectum. The stones were subsequently sent to the SC. Medical sources showed this correspondent images of the stones. Despite all assurances, the sources, fearing for their safety, didn’t allow TEHELKA to publish them.
Their fear is not unwarranted. This report is a key weapon in the battle. That is why several high-profile teams visited the hospital last month. Sources say that teams from the CBI, the West Bengal CID and the Chhattisgarh Police visited Dr SK Santra, superintendent of NRS Medical College, to request unofficial copies of the report. “The West Bengal CM wants to see the report,” a CID officer told Dr Santra.
That is why this battle is not Sori’s alone; it is not being waged in Chhattisgarh alone. What happens here will get in the way of how history books can describe India’s war against its ‘gravest internal security threat’. What happens here will get in way, perhaps, of how India can describe itself. It is now the description of stones.
Sources told TEHELKA that the gynaecological exam of Sori reveals: “Two objects seen in the fornices, one blackish and one brownish, 2.5 x 1.5 x 1 cm.” The rectum exam found: “An irregular hard object, brownish in colour, was manually removed.” This matches the images TEHELKA has seen. Further, an MRI scan of her lower spine reveals “annular tears”, corroborating allegations that Sori was brutally beaten in custody.
The medical report was submitted before the SC on 2 December. Subsequently, in a perplexing order, the SC allowed the Chhattisgarh government 45 days to respond – the next hearing is on 23 January – and sent Sori back into their custody. After pleas from her lawyer that she be shifted to a prison outside the state, the SC itself asked for her transfer from Bastar to Raipur Jail. There are fears about what might happen during that 385 km journey in police custody.
Asked to explain the stones, Dantewada SP Ankit Garg insisted the allegations are fabricated. “She was in our custody for only 48 hours from 8-10 October. It is a medical miracle if someone with stones inserted in her private parts can survive so long,” he told TEHELKA.
In a letter sent to her family from jail, a copy of which is with TEHELKA, Sori specifically accused Garg. “He has taken my all. I have been tortured in ways I can’t describe here,” she wrote. “I pray to God that nothing happens to me until I have given my testimony to the SC.” At present, Sori is in judicial custody for attacking a Congress leader, bombing a tehsil office, and couriering funds to the Maoist party. TEHELKA earlier detailed how the cases are fabricated, and how Sori is an innocent tribal caught in the crossfire. (Refer to The Inconvenient Truth of Soni Sori, 15 October). “I don’t know how this struggle will end. Sometimes the condition of my body becomes quite serious,” Sori added, “but my struggle is not mine alone.”
Tusha Mittal is a Principal Correspondent with Tehelka. tusha@...
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