We greatly appreciate and welcome the 72nd Parliamentary Standing Committee on Health and Family Welfare’s Report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India” that was presented in the Rajya Sabha and laid on the table in the Lok Sabha on30 August 2013. Indeed it is an extraordinary report and we commend its candid, transparent contents, which reflect the Committee’s acknowledgement of the unethical nature of the HPV trials conducted in the country. According to this 72nd report, the Parliamentary Standing Committee has been looking into the issue of HPV trials on children in Andhra Pradesh (Khammam district) and Gujarat (Vadodara district) since April 2010 following reports of deaths of some of the children.
In the HPV trials, Program for Appropriate Technology in Health (PATH) with the support of Bill and Melinda Gates Foundation (BMGF), with approval from the Western Institutional Review Board (WIRB)[all three private international parties], with donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK)and in partnership with Indian Council of Medical Research (ICMR), with the machinery of the State governments of Andhra Pradesh and Gujarat, through the National vaccination programme, delivered and administered HPV vaccines to 10-14 year old girls in Khammam (AP) and Vadodara (Gujarat) districts.
The Committee’s findings, endorsed by MPs from all political parties, are wide-ranging: the nature of the project, the role of ICMR, the role of Drug Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry Committee formation and function and the role of PATH. The Committee report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.
Nature of Project: The Parliamentary Committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it. The report further states, “the demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply”.
PATH by carrying out the clinical trial on the pretext of observation/demonstration project has violated all laws and regulations laid down for clinical trials by the Government of India.
Role of ICMR: The Committee questions the role of ICMR in the entire trial. Section 3.10. of the report states, “unable to understand as to how ICMR could commit itself to support the use of the HPV vaccines in an MOU signed in 2007 even before the vaccine was approved for use in the country. The Committee questions the decision of ICMR to commit itself to promote the drug for inclusion in the UIP even before any independent study about its utility and rationale of inclusion in the UIP was undertaken.
The Committee observes that ICMR representatives, instead of ensuring highest levels of ethical research standards in research studies, apparently acted at the behest of PATH who was promoting the interest of manufacturers of the HPV vaccine.
The Role of DCGI: Report section 4.3: “The Committee examination has proved that DCGI has played a very questionable role in the entire matter. The DCGI has remained as a silent spectator thereafter even when its own rules and regulation were being so fragrantly violated the approvals of the clinical trials, marketing approvals and import licenses by DCGI. Therefore the role of DCGI in this entire matter should also be enquired into”.
Conflict of Interest: The Committees ought information from the MOHFW as to whether the members of the Inquiry Committee were asked to file a conflict of interest declaration. To this the Ministry had responded that no written conflict of interest declarations were sought from the core members of the inquiry Committee as well as experts. The Committee picked just one member of the Committee from AIIMS and found that MSD, the manufacturer of HPV vaccine Gardasil, was sponsoring and funding the trial in the member’s department. This demonstrates a serious conflict of interest of this member of the inquiry Committee. The Committee has strongly deprecated the government for appointing the Committee to inquire into such a serious matter in such a casual manner even without ascertaining as to whether any of the members of the said inquiry Committee have any conflict of interest with the subject matter of inquiry.
The report also observes that ICMR representative “instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of PATH in promoting the interest of the manufacturers of the HPV vaccine”.
The Committee report also found that “the Ministry appointed a senior official of ICMR (described as Resource Person) to assist the Inquiry Committee. The concerned individual was the main link between ICMR and PATH, and had participated actively in all discussions, meetings and helped PATH to carry out the project proactively in every respect right from the beginning in October, 2006. As such he had a clear conflict of interest and could not be relied upon to give correct information and unbiased opinion. Indeed he should have been summoned as a witness to answer questions and not as an official Resource Person attached to the Enquiry Committee.”
The Committee takes a serious view of the violations and strongly recommends that on the basis of the facts, PATH should be made accountable and the Ministry should initiate appropriate action in the matter including taking legal action against PATH for breach of various laws of the land and possible violation of laws of the country of its origin.
The Committee, therefore, recommends that every effort should be made to expedite the report Committee so that real facts about the HPV vaccine trial are made known without any further delay and collective measures, not only in respect to this trial, but for all such ongoing /proposed clinical trials of drugs/vaccines, are taken.
The Committee also recommends that the department should, at least now, work in close coordination with other concerned departments/ organizations to undertake a comprehensive analysis of the process of granting permission to research studies having hazardous effects on health and put in place a foolproof system for pre-empting unethical research studies. The Committee has taken serious note of the fact that both the Ethics Committees were registered only as a formality and they did not play their designated role, a clear dereliction of their duty.
The Committee states that the act of PATH is a clear cut violation of the human rights of these girl children and adolescents and is a serious breach of medical ethics. The Committee recommends that “the National Human Rights Commission (NHRC) and National Commission for Protection of Children Rights (NCPCR) may take up this matter further from the point of view of violation of human rights and child abuse”.
Though, the Committee brought up the Insurance to the girls it has not mentioned the compensation in its report from the sponsor or an ex gratia to the parents of the girls who died following the administration of the trial. We demand that the parents of the girls who died and the children must be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents of the girls and no assent was taken from the girls who were given the HPV vaccine, and no follow up or proper management of adverse events and serious adverse events during the trial was done. The Committee report also does not mention on the funding from Gates and other sources; and money spent by ICMR and state governments.
We welcome the recommendations and sincerely hope that the contents and recommendations of the 72nd report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow up and outcomes of the Committee’s observations and recommendations. We also hope that the extremely critical insights and recommendations by the Committee will not be sidelined, only to set up further committees without substantive, concrete action.
Sama Resource Group for Women & Health
Jan Swasthya Abhiyan
All India Drug Action Network
Drug Action Forum Karnataka
Date: 2 September 2013
Please find below the link to the SEVENTY-SECOND PARLIAMENTARY STANDING COMMITTEE REPORT ON “ALLEGED IRREGULARITIES IN THE CONDUCT OF STUDIES USING HUMAN PAPILLOMA VIRUS (HPV) VACCINE BY PATH IN INDIA”