India: Ministry labels PATH’s Gates Foundation-funded HPV vaccine trials a sordid & unethical affair Print E-mail


 September 2, 2013


It’s a PATH of violations, all the way to vaccine trials: House panel

Committee questions roles of ICMR, Drug Controller in the “intriguing” 2010 episode

By Aarti Dhar

Read the full report from India's MINISTRY OF HEALTH & FAMILY WELFARE HERE

Accusing the international organisation PATH (Programme for Appropriate Technology in Health) of exploiting with impunity the loopholes in the system during a trial of Human Papillomavirus (HPV) vaccines, a parliamentary panel has also questioned the roles of the Indian Council of Medical Research and the Drug Controller-General of India in the entire episode.

The issue pertains to trials conducted by two U.S.-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010. The trials were stopped only after the matter received media attention following the death of seven girls.

In its report on “Alleged Irregularities in the Conduct of Studies using HPV Vaccines by PATH in India” presented to Parliament, the committee has said ICMR representatives apparently acted at the behest of PATH in promoting the interests of the vaccine manufacturers, and recommended that the Health Ministry review the activities of the functionaries of the Council involved in the PATH project

As for the DCGI, the approvals of clinical trials, marketing approval and import licences by the agency “appear to be irregular” and its role “in this entire matter should also be inquired into.”

The Department of Health Research/ICMR “have completely failed to perform their mandated role and responsibility as the apex body for medical research in the country. Rather, in their over-enthusiasm to act as a willing facilitator of the machinations of PATH, they have even transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them.”

The committee failed to understand why the ICMR “took so much interest and initiative in this project when the safety, efficacy and introduction of vaccines in India are handled by the National Technical Advisory Group on Immunisation.”

How could the ICMR commit itself to supporting “the use of the HPV vaccine” in an MoU signed in 2007, even before it was approved for use in the country, which actually happened in 2008? The committee also questioned the ICMR’s decision to commit itself to promoting the drug for inclusion in the Universal Immunisation Programme before any independent study on its utility and rationale of inclusion in the UIP was undertaken.

Describing the entire matter as “very intriguing and fishy,” the committee said the choice of countries and population groups (India, Vietnam, Uganda and Peru); the monopolistic nature, at that point of time, of the product being pushed; the unlimited market potential and opportunities in the universal immunisation programmes of the respective countries “are all pointers to a well-planned scheme to commercially exploit a situation.”

Had PATH been successful in getting the HPV vaccine included in the universal immunisation programme of the countries concerned, windfall profits would have been generated for the manufacturer(s) by way of automatic sale, the committee said. It asked the government to take up the matter with these countries through diplomatic channels.

Flouting ethics
Drawing attention to gross violation of ethics during the conduct of trials, the committee members said that in Andhra Pradesh out of 9,543 consent forms, 1,948 had thumb impressions, while hostel wardens signed 2,763 others. In Gujarat, out of 6,217 forms, 3,944 had thumb impressions. The data revealed that a very large number of parents/guardians were illiterate and could not even write in their local language, Telugu or Gujarati.

It was shocking to find from one of the reports that out of 100 consent forms for Andhra Pradesh, project signatures of witnesses were missing in 69 forms. In many forms there were no dates. One particular person had signed seven forms. In fact, the legality of the State government directing headmasters of all private/government/ashram/schools to sign the consent forms on behalf of parents/guardians was highly questionable. The absence of photographs of parents/guardians/wardens on consent forms and of signatures of investigators, the fact that signatures of parents/guardians did not match with their names; and the date of vaccination being much earlier than the date of signature of parents/guardian in the consent forms spoke of grave irregularities, the report said.

The committee said PATH should be made accountable and the government should take appropriate steps in the matter, including legal action against it for breach of laws of the land and possible violations of laws of the country of its origin.

Describing this act of the PATH as a clear-cut violation of human rights and case of child abuse, the Committee has recommended that the National Human Rights Commission and the National Commission for Protection of Children Rights take up this matter. The National Commission for Women should also take suo motu cognisance of this case as all the poor and hapless subjects were female.

The Health Ministry should report the violations indulged in by PATH to the World Health Organisation and the United Nations Children’s Fund so as to ensure that appropriate remedial action was initiated worldwide, the committee said.

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 Monday September 2, 2013

BREAKING NEWS: US-Based Agency PATH Violated Law During HPV Vaccine Trials in India

By: Christina England

Indian Parliament Writes Scathing Report Concerning The Conduct of PATH During HPV Vaccine Trials.

On 30th August 2013, The Mail India Online, reported that the Indian Council of Medical Research (ICMR) had allegedly played hand in glove with the US NGO, PATH, to promote the commercial interests of both cervical cancer vaccine manufacturers, which they say were linked to the deaths of several young Indian girls.

The Mail stated that the Indian Parliamentary panel had found the ICMR guilty of lending its platform to PATH, in an "improper and unlawful manner." [1]

On the same day as the Mail's article was published, an extremely damning document was released by the Indian Parliament, entitled: Seventy Second Report on Alleged Irregularities In The Conduct Of Studies Using Human Papilloma Virus (HPV) Vaccine By PATH In India, supporting their claims. [2]

The Parliamentary report, stated that the committee had found the Indian Council of Medical Research (ICMR), guilty of helping the US NGO, PATH (Programme for Appropriate Technology in Health), facilitate studies relating to the cervical cancer vaccine on young girls, endangering their lives.

The forty-three-page report clearly stated that PATH's presence in India had been illegal.

Section 1.1 of the report stated that:
"During March, 2010 the entire world was shocked by the media reports about the deaths of some female children and adolescents in Khammam district of Andhra Pradesh after being administered Human Papilloma Virus (HPV) vaccines. The vaccination trials were carried out by an American agency viz. Programme for Appropriate Technology in Health (PATH). The project was reportedly funded by the Bill and Melinda Gates Foundation, an American charity.
The committee stated that:
"Several questions were asked and concerns expressed in the media and well meaning quarters on the role of government agencies including Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) in approving and facilitating the trials, which was against all laws of the land and even international ethical norms and rules; misuse of government funds, man-power facilities and infrastructure for the private project of dubious nature; use of logo of Natural Rural Health Mission (NRHM), an official programme of the Union Government during these vaccination drives to give it respectability and official endorsement ; and above all the blatant violation by PATH of all regulatory and ethical norms laid down by the Government of India for the purpose as also possible violations of such norms prescribed and very scrupulously enforced in the Country of its origin viz. United States of America."
The committee were extremely scathing of PATH's activities, stating that it was their belief that in trying to get the HPV vaccination included into the universal immunization programmes, PATH had resorted to an element of subterfuge calling the clinical trials by several different names including Observational Studies and Demonstration Projects. The committee stated that in doing so. PATH had severely jeopardised the safety and well being of young girls and adolescents by using self-determined and self-servicing nomenclature which was not only highly deplorable but a serious breach of the law of the land.

Furthermore, the Indian parliament stated that it had been clear from as far back as October-November 2006, that PATH's main objective was to generate evidence supporting the introduction of the HPV vaccine Gardasil being included into the Indian government-funded immunization program.

However, PATH was not the only organization criticized; the report also criticized several others including the Drugs Controller General of India (DCGI), stating:
"The Committee's examination has proved that DCGI has also played a very questionable role in the entire matter. Initially, it took a call that since human subjects, as part of the studies, were receiving invasive intervention like immunization, clinical trials rules must be enforced. However, it remained a silent spectator thereafter, even when its own rules and regulations were being so fragrantly violated. The approvals of clinical trials, marketing approval and import licences by DCGI appear to be irregular. Therefore, the role of the DCGI in this entire matter should also be inquired into."
Not only did the committee find clear cases of conflicts of interest they also found that many of the consent forms for the vaccination had been forged. The forms were supposed to be signed by a parent or guardian if the subject was under the age of consent. However, the report stated:
"In the case of Andhra Pradesh 9,543 forms were signed, 1,948 had thumb impressions while hostel warden had signed 2,763 forms."
Of course this could not have come sooner for the three brave activists and campaigners who in January 2013, submitted a Writ Petition to the Supreme Courts of India, criticizing these very same organizations. I say this because their case was heard today, Monday 2nd September, just three days after this damning report was released.

Background to This Case
For those of you who have little or no knowledge of the Writ Petition here is a little background information.

In January 2013, I wrote an article titled, The Writ Petition, documenting the historical moment when activists Kalpana Mehta and Nalini Bhanot, along with Dr. Rukmini Rao, President of the Gramya Resource Centre for Women in India, filed a writ petition with the Supreme Court of India under Article 32 of The Constitution of India for Women. The petition was filed against:
  • Drug Controller General of India,
  • Indian Council of Medical Research, State of Andhra Pradesh,
  • State of Gujarat,
  • PATH International,
  • GlaxoSmithKline Asia Private Limited,
  • MSD Pharmaceuticals Private Limited.
The petition outlined a series of serious allegations regarding the HPV vaccines Gardasil® and Cervarix®. Petitioners Kalpana Mehta, Nalini Bhanot and Dr. Rukmini Rao reported that the two HPV vaccines were illegally brought into the states of Andhra Pradesh and Gujarat and subsequently administered to thousands of young, vulnerable Indian children before the vaccines were known to be safe.

The three Petitioners told the court that even though the Indian government and the above organizations knew the HPV vaccines were of dubious value and of speculative benefits, they continued to allow a trial using both the Gardasil® and Cervarix® vaccines without regard to the potential endangerment of the lives of adolescent girls.

To read the complete story concerning this historical event please refer to reference [3]

After attending court today, Kalpana Mehta forwarded me the following press release:
A step forward in redressing of woes of 24000 victims of PATH-ICMR misadventure

A trial done by PATH with HPV vaccines on 24000 girls in Andhra Pradesh and Gujarat has been termed a "sordid incident" by the Parliamentary Standing Committee for Health and Family Welfare that found the entire matter "very intriguing and fishy". This trial has left in its trail at least 1200 girls in the two states with chronic health problems. A writ petition was filed before the Supreme Court praying for the identification of the health problems of these girls and provision of treatment, along with other prayers.

Notices were issued to the Government of India and the Drugs Controller by the Supreme Court in January 2013 but neither has bothered to file a reply. In this callous delay in court proceedings, the 72nd report of the Standing Committee released last week has proved to be a boon in disguise. The concerned officials from the ministry, ICMR and the DCGI, and also from PATH appeared before the Standing Committee but their explanations cut no ice.

This report was placed before the judges today and senior advocate Colin Gonsalves representing the petitioners reiterated the misery of the girls who are likely to be afflicted with serious conditions like convulsions, asthma, central demyelinating diseases, acute disseminated encephalomyelitis, idiopathic thrombopenia purpura, etc.; autoimmune conditions like thyroiditis and rheumatoid arthritis; and also by mental ailments that are serious enough to lead to suicides. The Standing committee has also stated that HPV vaccine as a possible, if not probable, cause of suicidal ideation cannot be ruled out.

Since the filing of the main petition many new facts about these vaccines and their serious health implications have come to light. Tomljenovic and Shaw examined post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil and concluded "Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies." It should be known that cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. Many of the symptoms following HPV vaccination are indicative of cerebral vasculitis such as intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits.

On 20 March 2013, the United States based Judicial Watch announced that, it has received documents from the Department of Health and Human Services (HHS) revealing that its National Vaccine Injury Compensation Program (VICP) has awarded $5,877,710 (US dollars) to 49 victims including two deaths in claims made against the highly controversial HPV (human papillomavirus) vaccines.

Meanwhile a fact finding mission undertaken by NGO's in the project areas in Gujarat in June 2013 indicated that many of the girls have already got married and moved away making it difficult to trace and treat them.

The petitioners had therefore asked by way of interim relief that all the vaccinated girls be examined by qualified medical practitioners to ascertain their health status and provide appropriate medical care.

Beyond these 24000 girls the other consumers of the two vaccines Gardasil and Cervarix are also at risk because the two companies have not bothered to update their product information to include serious side effects as they are emerging and being included in the inserts of other countries.

Also countries abroad both companies provide information to the patients/users that informs them of the effectiveness, potential problems and symptoms for which the users should approach a medical facility. The petitioners felt that this information is also the right of Indian patients, girls, and women who can then make a rational choice and take timely decision to seek medical care.

Nalini Bhanot and Kalpana Mehta Tel: 9899905851 and 09425056985

PATH Had Suprisingly Little To Say

PATH responded to the parliamentary report by stating the following on their website:

"Today, the Indian Parliament's Standing Committee on Health and Family Welfare released a report critical of a cervical cancer vaccine demonstration project conducted in India from 2009 to 2010 through a collaboration among PATH, the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat.

PATH welcomes public discussion about the role of vaccines in preventing life-threatening diseases such as cervical cancer, and we thank the committee members for their time and effort in reviewing this matter. We support the adoption of reasonable measures to further strengthen and clarify protections for individuals participating in research projects. However, we are troubled by the report's inaccurate characterization of this important work.

PATH, an international nonprofit organization, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines. The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against human papillomavirus (HPV), the primary cause of cervical cancer." [4]

Conclusion
After reading the Indian parliamentary report, it is clear that PATH acted illegally and in doing so endangered the lives of thousands of innocent Indian girls, many as young as fourteen, proving that once again, we have evidence that the Bill and Melinda Gates Foundation have funded a project of dubious scientific and health value.

Ever since the two HPV vaccines Gardasil and Cervarix hit the market, there have been continual reports of deaths and disabilities caused by the vaccines. Despite mounting evidence, however, governments from around the world have refused to take action and ban these dangerous vaccines.

Thanks to the courage of Kalpana Mehta, Nalini Bhanot and the President of the Gramya Resource Centre for Women in India, Dr. Rukmini Rao, however, this may be all set to change very soon.

References
1. http://www.dailymail.co.uk/indiahome/indianews/article-2407569/Indian-Council-Medical-Research-endorsed-illegal-US-vaccine.html#ixzz2debpyUSM

2. http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/72.pdf

3. http://weeklyblitz.net/2013/04/the-writ-petition/

4. http://www.path.org/news/press-room/642/
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Christina was born and educated in London, U.K. She received an A Level in Psychology and a BTEC in Learning Disabilities. She has spent many years researching vaccines and adverse reactions. She has an HND in journalism and media and is currently writing for the American Chronicle, the Weekly Blitz and Vaccination Truth on immunization safety and efficacy.

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 Tuesday September 3 2013

House panel slams govt bodies over clinical trials

DHNS

New Delhi: A parliamentary panel has strongly reprimanded two leading central agencies – the Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) – for violating every rule in the book to go ahead with an illegal trial that would have benefited only the vaccine's manufacturers.

Intended to protect young girls against cervical cancer caused by the Human Papillomavirus (HPV), the 2009 trial was carried out by Andhra Pradesh and Gujarat governments with the approval of the ICMR and DCGI.

In the wake of several allegations of serious violation of ethical norms and the death of girls receiving the vaccine, the Centre cancelled the trial midway and instituted an inquiry, which identified “several deficiencies in the planning and implementation of the project” in its final report.

Surprisingly, the probe panel did not fix the accountability on any individual, attracting the wrath of the House panel that submitted its report on August 30.

Probe panel member Sunita Mittal, a former professor at the All India Institute of Medical Sciences, Delhi, had a “conflict of interest” as one of the HPV vaccine-manufacturing firms was sponsoring one of her research projects.

Both the DCGI and ICMR were pulled up for dereliction of duty, because of which poor and illiterate girls were exposed to the illegal clinical trial. No consent was obtained from the girls and their parents.

The ICMR went to the extent of committing itself to support “use of the HPV vaccine" in a 2007 agreement, even before the vaccine was approved for use in the country, which actually happened in 2008.

The apex medical research body acted as a “willing facilitator to the machinations of PATH”, which deserved the strongest condemnation and strictest action. The government's highest advisory body on vaccines, the National Technical Advisory Group on Immunisation (NTAGI), was bypassed.

The DCGI too played a questionable role. “It remained a silent spectator thereafter, even when its own rules and regulations were being so flagrantly violated. The approval of clinical trials, marketing approval and import licences by the DCGI appear to be irregular. The role of the DCGI should be probed,” suggests the panel.

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Saturday August 28 2013

Panel raps government over clinical trials, lapses

Rupali Mukherjee, TNN

MUMBAI: In a further indication of the rot in the country's healthcare system, a parliamentary panel has rapped the government for gross irregularities in drug trials, under-reporting and lapses in monitoring serious adverse events and lethargy in safeguarding health, in studies on cervical cancer prevention vaccine by a US-based non-governmental agency. Charging the government for inaction, the parliamentary committee on health says in a report that the issue has been diluted with no accountability fixed on erring officials for serious violations committed in the studies which led to the death of hapless tribal children three years back.

Raising concern on the manner in which the US NGO, PATH (Programme for Appropriate Technology in Health) set up office in the country, the panel says it conducted clinical trials for HPV vaccines under the garb of "observational project" by violating all guidelines.

The trials were suspended following deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-2010 after being administered the HPV vaccines. The vaccines were provided by two pharmaceutical companies - Merck and GlaxoSmithKline - through PATH, during studies carried out in collaboration with government agency, Indian Council of Medical Research and the states. The project was reportedly funded by Bill and Melinda Gates Foundation.

The sole aim of PATH, the 72nd report on Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine says, was to "promote the commercial interests'' of the manufacturers, who would have benefitted if it was successful in getting the HPV vaccine included in the government-run Universal Immunisation Programme.

The report submitted in the Parliament on Friday comes at a time when the pharma industry has been complaining of inordinate government delays in approvals of drug trials involving human subjects.

Terming it "a serious breach of trust by any entity", and a "violation of human rights of these girl children who were mostly unaware of the implications'', the panel has asked the government to report the violations to international bodies like World Health Organisation and UNICEF. It has also asked the ministry of health to take up the matter through the ministry of external affairs with the US government so as to ensure appropriate action is taken against PATH.

The report has pulled up the drugs controller general as well as Indian Council of Medical Research. It says DCGI played a "questionable role'', and "remained a silent spectator, even when its own regulations were being violated", while "approvals of clinical trials, marketing approvals and import licenses appear to be irregular".Though the issue was reported after the deaths in 2010, this report details the role of PATH, involvement of regulatory agencies like ICMR and DCGI, lapses in drug side-effects, conflict of interest and the various loop-holes in the system.

The panel says that ICMR instead of ensuring ethical standards in research studies, apparently acted at the behest of PATH in promoting the interests of HPV manufacturers, and that it should have taken the National Technical Advisory Group on Immunization (NTAGI), on board. The safety, efficacy and introduction of vaccines is handled by NTAGI.

Significantly, not only were the adverse events under-reported and not monitored during the studies, the committee noted that HPV vaccine as a possible, if not probable cause of suicidal ideation.

According to approvals given to the companies, vaccines were given to children irrespective of age in the case of Merck's Gardasil vaccine, while permission was given to use GSK's Cervarix vaccine in children (10-14 years), while clinical trials had been conducted on subjects in the age-group of 18-35 years. Thus the safety and well-being of subjects were completely jeopardized, the report adds.

The panel has sought further tightening of regulations, action against the wrong-doers, strict monitoring of serious adverse events during drug trials through an independent mechanism, and government agencies ICMR and DCGI to strictly adhere to regulations, guidelines and methodology like informed consent from subjects. The committee found glaring discrepancies in the informed consent taken from subjects who were given the vaccine.
 

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June 7 2006

Gates Funds New HPV Vaccine Program at PATH

On June 5th, the Bill & Melinda Gates Foundation announced a five-year, $27.8 million grant to PATH for program research in India, Peru, Uganda, and Vietnam intended to inform country decisions about HPV vaccine introduction to prevent cervical cancer. PATH will help plan for and pilot introduction in the four countries, with the goal of informing regional and global vaccine introduction efforts and international financing plans. They will work in partnership with the national governments, Merck, and GlaxoSmithKline and will coordinate closely with other key stakeholders including the World Health Organization, the International Agency for Research on Cancer, Harvard University, and the Catalonian Institute of Oncology.