By Leslie Carol Botha
January 8, 2013
New Delhi, India. In a historic move, Kalpana Mehta, Nalini Bhanot and Dr Rukmini Rao President of the Gramya Resource Centre for Women, filed a Writ of Petition on October 29, 2012 under Article 32 in the Constitution of India outlining serious allegations regarding the trialing of the HPV vaccines Gardasil® and Cervarix® on thousands of girls between the ages of 10 and 14, in the states of Andhra Pradesh and Gujarat. The Petitioners, represented by renowned public interest senior advocate Colin Gonsalves of the Human Rights Law Network, presented the case before the Supreme Court on January 7, where it was immediately accepted. The Supreme Court has asked the Government of India to immediately file its reply in the matter.
The women issued a press release on January 7, 2013 reporting on the acceptance of their historic case by the Supreme Court of India.
The Petitioners maintain the vaccines were illegally brought into the States by the Program for Appropriate Technology in Health (PATH) and administered to Indian children before there safety and efficacy was established. The Petitioners believe that the safety and efficacy of the HPV vaccines, Gardasil® and Cervarix® , marketed in India by MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd., are unproven and potentially hazardous. They are challenging the licensing for use in the private sector stating that instead of examining the safety and efficacy of Gardasil® and Cervarix®, the project was designed to influence the Indian government to adopt the vaccines for introduction in the public sector.
The Petition implicates the: Indian Drugs Controller for licensing the HPV vaccines without sufficient research on their safety and efficacy, and the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010. The Parliamentary committee also neglected to take any action on the report of the enquiry committee (set up by its own organization) despite confirmation of the ‘gross violations’ found in the PATH project with “respect to procedures for taking informed consent, inadequate health facilities for dealing with adverse events and medical emergencies.”
The Petitioners maintain that after two years of enquiry the government of India did not initiate any to action to “redress situation” or to admonish/punish PATH and the Indian Council of Medical Research (ICMR) for the ensuing violations.
Respondents in the petition include:
- Union of India; Secretary, Ministry of Health & Family Welfare, Government of India
- Drug Controller General of India (DCGI), Central Drugs Standard Control, New Delhi
- Indian Council of Medical Research, Ansari Nagari, New Delhi
- State of Andhra Pradesh, Principal Secretary (H&FW), Commissioner Health and Family Welfare, c/o Directorate of Health Services, Gov’t of Andhra Pradesh, Naharlagun, AP
- State of Gujarat, Principal Secretary (H&FW), Department of Health & Family Welfare, Sachivalaya, Gandhinagar, Gujarat
- PATH International, New Delhi
- GlaxoSmithKline Asia PVT LTD, Nashik, Maharashtra (Cervarix® )
- MSD Pharmaceuticals Private Limited, Gurgaon (Gardasil® )
The Petitioners have stated that ‘according to studies done by the multinational companies abroad, a certain percentage of subjects in the PATH trialling of the HPV vaccines have either suffered serious systemic adverse reactions or autoimmune disorders’ post HPV vaccination. They believe there may be as many as 500 girls In Andhra Pradesh and 700 others in Gujarat may have suffered a serious adverse event or immune disorder.
Trial subjects were not provided ICMR guidelines for informed consent for bio medical research. Neither the students, tribal girls, administrators or parents were told of the potential for side effects or adverse vaccine reactions, nor were there protocols in place for follow-up medical evaluations. There is also concern that the provisions in the Drugs and Cosmetics Act regarding the protection of children and select groups as research participants were not adhered to.
Figures submitted by the Petitioners are based on the international reporting of adverse reactions based on the administration of the vaccine to ‘healthy’ girls. Petitioners are also concerned that the targeted population in Andhra Pradesh and Gujarat are overwhelmingly ‘anaemic’ and malnourished.
In May 2012 the Parliamentary Standing Committee on Health and Family Welfare brought out its 59th report as it found gross violations of the laws of the land in granting licences and matters relating to post licensing monitoring. It has asked for action to be taken against the officials as well as the experts involved. In the case of Cervarix® and Gardasil® there have been violations at each step of licensing. Right from licensing their import and administration to unexposed age groups, to selective changes in product information, to not updating product information and even in refusing to carry out post marketing studies the two companies have undermined the authority of the Drugs Controller and defrauded Indian citizens. Unfortunately the Drugs Controller has played into their hands.
It is more than two years since the Standing Committee asked for action based on enquiry and as yet no action has been taken even on the proven lapses of the PATH project and enquiry into licensing has not even begun.
On July 3rd, the Union Government of India issued a warning letter to PATH about consent and monitoring discrepancies and violations that had taken place in conducting the HPV vaccine clinical trials schoolgirls in tribal districts. The warning was to ensure that the violations do not occur in the future. The initial violations came to light after seven girls reportedly died while enrolled in the HPV vaccine trials. The Indian Council of Medical Research (ICMR) suspended the Phase-V post licensure clinical trials in April 2010 after women’s organisations raised the issue of deaths among the participants, use of vulnerable population, and lack of informed consent. The Parliamentary Standing Committee also asked for enquiry into the PATH project and appropriate action.
On August 25, 2012, The Hindu printed an article entitled: “Government Warns Path,” reporting that 14,091 schoolgirls in Andhra Pradesh had been administered the HPV vaccines, Gardasil® and Cervarix® (donated by Merck & Co, Inc. and GlaxoSmithKline) and 10,686 in Gujarat.The author, Aarti Dhar, stated the government had been informed of the deaths of 1,317 schoolgirls who were enrolled in the clinical trials over the last three years.
Cardiovascular problems and cancer were indicated in 679 of those deaths and 431 additional adverse events post-vaccination. The Hindu also state 211 deaths had been reported in the last year (up until August 2012). Out of those deaths 82 causalities were listed as cardiovascular and 66 of those as cancer. Death reports also include: 5 cerebro-vascular, 12 anti-diabetic and 8 anti-viral/anti-fungal; 38 deaths were listed for other reasons. Petitioners believe that since PATH did not monitor the health of the trial participants post-vaccination there may be 1200 or more girls with medical problems post-vaccination who have yet to be discovered and attended to.
- There was an undisclosed international agenda between the Bill & Melinda Gates Foundation (BMGF), PATH and the World Health Organization (WHO) to provide a platform for marketing the HPV vaccines in the private and public sector.
- BMGF, PATH and WHO were criminally negligent trialling the vaccines on a vulnerable, uneducated and under-informed population school administrators, students and their parents who were not provided informed consent or advised of potential adverse effects or required to be monitored post-vaccination.
- The Government of India was provided false safety and efficacy data and that the HPV vaccines were licensed without adequate research.
- Merck & Co Inc., and GlaxoSmithKline and were negligent in their denial over the presence of viral DNA in the vaccines. Experts have recognized that the risks associated with recombinant vaccines (genetically modified microbes) are not completely known. It is universally accepted, however, that they can cause infections and tumours including cancer.
- The Drug Controller has not developed standards of contamination for medicines licensed for use in India.
The Petitioners are requesting the following reliefs:
- An order directing Respondent No. 6 and Respondents No. 2, 4 & 5 to give full access to the research and information on the PATH project and all activities regarding HPV vaccines in India to Respondent No. 9 (CMC, Vellore).
- An order directing the Director, Respondent No. 9 to constitute a team including therein local reputed legal experts and NGOs to conduct a study as to the number of deaths and persons adversely impacted by the administration of the HPV vaccine by PATH (Respondent No. 6) and the State Governments of Gujarat and Andhra Pradesh (Respondents 4 & 5) by visiting the families of trial victims who died and conducting necessary medical examination to determine the status of health of the remaining trial victims from Andhra Pradesh and Gujarat.
- An order directing Respondent No. 9 on the basis of a protocol it designs, to determine the culpability of PATH (Respondent No. 6) and Respondents No. 4 & 5 (State Governments of Gujarat and Andhra Pradesh) in causing adverse reactions including death and to make a report to the Court in this regard and to make recommendations with regards to compensation and continuing medical treatment.
- An order restraining ICMR (Respondent No. 3) from entering into Memorandum of Understanding (MOU’s) with pharmaceutical companies and multinational agencies and NGOs to conduct research into specific products, and a further direction to ICMR (Respondent No. 3) to thereafter independently evaluate products and new international medical developments for their applicability and suitability in India.
- A direction to MoHFW (Respondent No. 1) to produce before this Court a plan of action for dealing with the criticisms made by the 59th Report dated 8.5.12 of the Parliamentary Standing Committee on Health and Family Welfare, and further to develop in-house technical competence and staff to monitor clinical trials and the marketing of drugs in India.
- An order directing the registration of the ‘First Information Reports’ (FIRs) the starting of criminal investigation and the institution of prosecutions on by a special investigation team (SIT) of those Respondents found guilty of committing criminal offenses in respect of the deaths, adverse reactions and falsification of records during the PATH project.
- Directions by the Hon’ble Court to act as guidelines until such time as a statute is enacted for civil and criminal liability for all clinical trials taking place in the country.
- An order directing the Respondents and all Ethics Committees in the country to generate financial and human resources for technical and ethical evaluation of bio-medical research projects and for monitoring their execution and to place their decisions in the public domain on a website.
- An order revoking the licenses / clearances granted by the DCGI (Respondent No. 2) to GlaxoSmithKline and MSD Pharmaceuticals Private Limited (Respondents No. 7 & 8) for the HPV vaccine and for a further order to the DCGI (Respondent No. 2) to recall all the products and not to allow any further sale or use of the HPV vaccines.]
- An order directing the MoHFW (Respondent No. 1) to conduct an independent enquiry into licensing of the two HPV vaccines as recommended Parliamentary Standing Committee.
- An order directing the Respondent No. 2 to put a moratorium on fresh approval of all biological (recombinant) vaccines as well as drugs till such time that technical capability of CDSCO is developed to properly evaluate.
- An order directing Respondent 1 and 3 to formulate guidelines to ensure that direct sale of pharmaceutical products are prohibited and fines commensurate with sales potential are imposed on Pharma companies or the agents as the case may be.
- An order for time bound strengthening of the Magic Remedies Act as recommended by the Parliamentary Standing Committee.
- An order directing Respondent No. 2 to stop all trials on newer forms including WHO, National Cancer Institute, U.S. on existing forms of the HPV vaccines among the vulnerable population until the scientific and epidemiological evaluation is done in India for marketing in the private sector.
- An order declaring the results of the PATH study as null and void and not to be used by the Respondents in any policy formulation.
- An order directing Respondent No.1 to compile all violations of procedure by PATH in various studies being done by it, Independently or in collaboration with Government agencies or bodies and adopt measures and develop code of conduct so that neither PATH nor any other foreign NGOs can subvert the lawful process in the country.
- An order directing Respondent No.1, 2 and 3 to put the post marketing clinical trials information, details of Ethics Committees and other detail affecting the wellbeing of the trails participants in the public domain.
The Petitioners believe that rights of the 24,000 girls recruited by PATH for the trials were “flouted as they were given the vaccine without a chance to make free informed choice.” In addition, the documented discrepancies, violations and unethical procedures conducted by the Respondents named in the Writ of Petition need to be addressed. They have moved forward with this historic court case undeterred by their government’s silence and are requesting that not only that the Gardasil® and Cervarix® licenses be cancelled, but that the vaccines be withdrawn from the market until their safety and efficacy has been proved and adheres to Indian rules and regulations.
The Petitioners stance on licensing is also held by the Indian Parliamentary Standing Committee on Health and Family Welfare who has uncovered that drug regulation favour companies. Their interest is to protect vulnerable medical consumers from ‘untried irrational drug formulations’ at the behest of pharmaceutical agencies who unlawfully disregard rules and regulations for their own agendas.
For more information on the historic Supreme Court filing by women activists in India contact: Kalpana Mehta firstname.lastname@example.org Tel: 9425056985, Nalini Bhanot email@example.com Tel:9899905851 or V. Rukmini Rao firstname.lastname@example.org Tel: 9440860271.