Interim report falls short of fixing responsibility

The three-member committee, set up to probe the alleged irregularities in conducting studies using human papillomavirus (HPV) vaccine by PATH in India, has identified several deficiencies in the planning and implementation of the project leading “to a crisis requiring suspension of the study,” but has fallen short of fixing responsibility on any individual or agency.

The interim report submitted to the Ministry of Health and Family Welfare said that it was true that a lot of negative vibes had been generated against this project due to mishandling of the situation, but the committee had not been able to identify a single event, individual or agency which could be held entirely accountable for it. All the deficiencies were minor in nature, which should serve as a lesson for strengthening clinical research in future rather than starting any punitive or disciplinary proceedings.

It said that considerable time and effort had been invested in getting all the approvals, but the same could not be said for its actual implementation. A collective effort was required to raise the standards of clinical research — first, in the arena of implementation of bioethical guidelines and second, in the monitoring and investigating adverse events following immunisation to raise public confidence.

The ‘Post-licensure observation study of HPV vaccination: demonstration project,' carried out by PATH in collaboration with the Indian Council of Medical Research (ICMR) in Andhra Pradesh and Gujarat since 2007, was suspended in April last year following reports of deaths and violation of ethics. The project is funded by a grant from the Bill and Melinda Gates Foundation and donation from HPV vaccine manufacturers — GSK and MSD.

While recommending that the third and final phase of the project should be allowed to continue as it would “provide the most useful information and did not involve any further vaccination,” the interim report suggested that other studies which were already under way or planned to be carried out using HPV vaccine be stopped, and resumed only after conducting reviews. It ruled out a blanket ban on or approval of such studies in future.

The report, however, warned that HPV vaccination was not to replace the cervical cancer screening programme, but to supplement it. Since the vaccine was expensive, an element of cost-effectiveness and determination of competing health immunisation priorities should have been addressed by the study. “The fact that the vaccine for the study was provided by the 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.”

S.S. Agarwal, the former Director, Sanjay Gandhi PGI of Medical Sciences; Lucknow; S.P.Agarwal, former Director-General of Health Services; and Suneeta Mittal, All-India Institute of Medical Sciences were members of the committee. The committee wanted a blurring of the distinction between routine, national immunisation programme and the research nature of the HPV vaccination study. “It is important that public-private partnership programmes be extra vigilant and ensure the authority of the State is not misrepresented.”

It said the seven deaths (five in Andhra Pradesh and two in Gujarat) among those administered the vaccine were “most probably” unrelated to it, as there was no characteristic and uniform pattern of illness preceding the deaths, or temporal/spatial clustering, going by the FIR.

Questioning the legality and morality of the circular issued by Andhra Pradesh, authorising hostel wardens and head masters to sign the consent on behalf of the minor girls included in the study, the report said everyone should desist from research on tribal population, except where it benefitted them. It made out a strong case for specific and separate legislation covering all aspects of biomedical and health research that involve human participants, and eliminating overlaps such as definition of clinical trial/clinical research that exist in Schedule Y of Drugs and Cosmetics Act Rules, and the ICMR guidelines.

Leader of the Communist Party of India (Marxist) Brinda Karat said the project itself was flawed, and as such the study could not be given to a non-governmental organisation that could not be held accountable and demanded action against those responsible. Ms. Karat, a member of the Parliamentary Committee on Health and Family Welfare, demanded a copy of the report.