This guest post has been sent by the SAMA team

Enquiry Committee Report on HPV Vaccine Projects – Of Undeniable Violations and Unidentifiable Violators

 Sarojini N and Anjali Shenoi

 Sama – Resource Group for Women and Health

This is in continuation with our previous post (17 May 2010) on the Human Papilloma Virus (HPV) vaccine ‘Demonstration Projects’ conducted by an American NGO PATH, in collaboration with the Indian Council of Medical Research (ICMR) and the two state governments of Andhra Pradesh and Gujarat. These projects have raised several pressing questions related to the ethics of biomedical research in India and the deflection of public health priorities in a context where the influence of the pharmaceutical industry is increasing.

Following strong opposition by civil society groups and a member of parliament, these ‘projects’ were temporarily suspended by the Ministry of Health and Family Welfare (MoHFW). At the same time, the Ministry also appointed a Committee to enquire into the “Alleged irregularities in the conduct of studies using HPV vaccine” with a time frame of three months to submit its report.

A year later, the report submitted by the Committee has identified several deficiencies in the planning and implementation of the project such as ambiguity in the nature and purpose, implementation of the projects, “the need for continued pharmacovigillance of the HPV vaccine” etc.

For instance on the issue of informed consent the report clearly establishes that “the legality and morality of the circular of the Government of Andhra Pradesh authorizing the Hostel Wardens and Head Masters to sign the consent on behalf of the minor girls included in the study is questionable”. Further it also states that “PATH has taken an insurance cover for itself” and raises the pertinent question as to why,  “no provision has been made of an insurance cover for any unforeseen event (including death) or residual morbidity related to the intervention for vaccine recipients in this study which is the usual practice for trails with NCE/ INDs?”

Despite stating the fact “that the vaccine for the study was provided by manufacturers free of cost does raise the concern about undeclared conflict of interest since the results of the study may be used to influence the decision by the Government”, the Committee fails to build upon this significant and alarming aspect.

The section of report on Responsibility is the weakest, as it lets off the hook all those involved in the project, by declaring the deficiencies in the project as “minor” and not “willful or fully anticipable (sic)”, and stating that “since there does not appear to be any overt mal-intention, no responsibility can be fixed”. To say that responsibility cannot be fixed with any “one” individual or organization is a dereliction of duty, and a convenient excuse for irresponsible and unethical conduct, thus setting a dangerous precedent. While identifying several deficiencies in the planning and implementation of the project, that the Committee’s report has failed to hold those involved in the projects such as PATH, ICMR, State Governments of Andhra Pradesh and Gujarat, the ethics committees accountable, is both disappointing and alarming at the same time. Rather than suggesting any disciplinary measures, the report identifies minor deficiencies as lessons for strengthening clinical research in future.

The entire issue has to be also seen in the context of the exponential rise in the number of clinical trials being conducted in the country. Reports suggest that more than a quarter of clinical trials in the world are now being conducted in India. Concurrently, the Ministry of Health itself reports that there has been a manifold rise in the number of deaths among clinical trial subjects in the past few years. There are justifiable apprehensions that lax rules and their implementation in India are reasons why more and more unethical trials are being conducted in India.

Contact: sama.womenshealth@gmail.com