By Aarti Dhar
The final report of the committee appointed by the Centre to enquire into alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine has found enough evidence to suggest that there were large-scale ethical violations during the conduct of “post-licensure observational study,” be it in obtaining the consent of the young girls on whom the trial was conducted, or on issues related to safety, follow up, and reporting of adverse events.
Though the report finally does not fix the responsibility on any individual or institution despite evidence, a three-member sub-committee that assisted the main enquiry committee has clearly said that the nature and objectives of these projects make it evident that they are in fact clinical trials, wherein the projects were a “study of a pharmaceutical product carried out on human participants” and “4 of 5 primary outcome measures proposed related to evaluation of the safety in the vaccine in population study.” The principles used to define a clinical trial by the Central Drugs Standard Control Organisation (CDSCO) and the Schedule Y of the Drugs and Cosmetics Act, 1954 can be applied to the demonstration product conducted by [the non-governmental organisation] PATH.
The three-member enquiry committee comprised S.S. Aggarwal, former director of Sanjay Gandhi Post-graduate Institute of Medical Sciences; S.P. Agarwal, former director general of Health Services; and Suneeta Mittal, head of Obstetrics and Gynaecology, All India Institute of Medical Sciences (AIIMS); while the committee that assisted them included Rani Kumar, dean of AIIMS; A.K. Dutta, head of Paediatrics, Kalawati Saran Hospital; and Y.K. Gupta, head of Pharmacology, AIIMS.
The committee has said that “by whatever name you call it, the project proposal has been carried out as research on human participants.