People's Democracy

 PATH Vaccine Trials Violate Safeguards: AIDWA

THROUGH a statement issued from New Delhi, May 12, the All India Democratic Women’s Association (AIDWA) has drawn attention to the findings of the HPV vaccine project enquiry report.

At the outset, the AIDWA statement expressed deep concern about the shocking irregularities and violation of rights committed in the HPV vaccine project as revealed by the final HPV enquiry report and its findings. The three member expert subcommittee that assisted the enquiry set up by the Health Ministry in the wake of complaints raised by Ms Brinda Karat (MP, Rajya Sabha), and organisations like the AIDWA, SAMA, JSY,  etc, in early 2010 about the HPV project has clearly underscored the widespread violation of ethical norms that has been identified. It is indeed disturbing that despite glaring evidence of human rights violations collated in detail by the experts, the report has not apportioned responsibility, nor has it recommended any action against those responsible for the lapses. The AIDWA has therefore demanded that the government should examine the expert findings seriously, fix accountability and ensure action against those at fault.

According to the organisation, many aspects of the project raise alarming questions about the direction and nature of bio medical research in our country.

The first question relates to the collaboration between a private body and the Indian Council of Medical Research (ICMR), in a project with questionable objectives. PATH, an international non-governmental organisation (NGO), had undertaken a study for two American pharmaceutical companies producing/marketing the expensive HPV vaccine. This effort was facilitated by the ICMR, which signed a memorandum of understanding (MOU) with PATH for “the purpose of dissemination to support decision making in the use of the HPV vaccine” in 2007. This occurred even before the vaccine was licensed for sale in the country in 2008. Evidently, the ICMR guidelines and protocols designed to provide safeguards for research subjects were breached right from the inception stage. It is a matter of concern that the interests of the NGO, and the business interests of the companies that it represented, received greater priority, while the interests of the Indian people were marginalised. The report brings out the facts clearly. The so-called “post-licensure observation study” has been found to be no less than “a clinical trial on human participants” by the experts. One of the experts, Dr Y K Gupta, questioned the PATH description of the project and quoted Schedule Y and Indian GCP guidelines. He said that since “the demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objectives include the study of serious adverse effects” and since the study has been carried out on “vulnerable populations,” “it is not clear” why the clinical trial protocol should not apply.

The second alarming aspect relates to the way in which the project was implemented, and consent was obtained from the “human” objects of the study. In June 2009, official orders were issued by the Andhra Pradesh government to headmasters and the hostel welfare officers to cooperate in the conduct of the programme. The circular instructed the authorities to sign the consent forms on behalf of the adolescent girls, as contacting the parents would be difficult in the agency area. The vaccination of as many as 23,000 girls --- mainly tribals --- in AP and Gujarat, with the consent forms duly signed by the hostel wardens, represents a gross violation of rights, as students could not possibly have objected to the higher authorities’ instructions. The callousness of the AP government in subjecting vulnerable children to such coercion can hardly be condoned.  As one of the experts, Rani Kumar, the dean of All India Institute of Medical Sciences (AIIMS) put it, “the consent forms were tantamount to inducement and indirect coercion, especially in the light of the high cost of the vaccine.” She has also pointed out that the team involved in conduct of the study on HPV had been very casual in its approach and had ignored many ethical issues. She said that “the consent forms have been very carelessly filled and are incomplete and probably inaccurate.”

A related lacuna was that due attention was not paid to the adverse side effects and vaccine related problems while conducting the trials. Dr Y K Gupta has pointed to the many discrepancies and gaps in the investigations of the deaths as shown in the available documents. He has implicated the lack of independent monitoring for the unacceptably long time gap in reporting the deaths. Furthermore, despite the existence of contraindications for the use of the vaccine, there were no checkups for contraindications before the girls were vaccinated. Thus, he concludes that the design neither took the issue of adverse side effects seriously nor was there adequate attention paid to the need for an independent monitoring agency. Another expert, Dr A K Gupta, has added that insurance cover for the girls was not ensured.

The third disturbing feature has been the attempt to gain credibility for the project by placing it alongside the public health programmes of the government. The use of the logo of National Rural Health Mission (NRHM) for a programme that was being carried out by a private agency was most reprehensible. It has been reported that the funds from the NRHM were used for monitoring and transportation of the vaccines to the field for use in the projects. This was a gross misuse of resources for a project that involved the interests of private drug companies. Similarly, the vaccination programme was claimed to be part of the public immunisation programme, thus achieving credibility. But how could the ICMR commit itself to promoting the drug for inclusion in the Universal Immunisation Programme (UIP), even before any independent study was made available? 

Thus the HPV enquiry report shows a damaging and disturbing contravention of existing safeguards and norms that have been built up over the years. The AIDWA has asserted that private interests cannot be permitted to make inroads into the health rights of the vulnerable sections of people. Hence, the organisation has put forth the following demands ---

1) Responsibility must be fixed for the violations and lapses in the HPV vaccine project and action to be taken against them.

2) Compensation must be provided for the suffering and loss to all those who were subjected to illegal trials.

3) There must be strict implementation of the existing guidelines and protocols. An effective legislation must be formulated to cover all aspects of bio-medical and health research in order to prevent the recurrence of such violations.