The three-member committee, set up to look into alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by PATH in India, has submitted its final report to the Ministry of Health and Family Welfare.
This information was given to the Parliamentary Standing Committee on Health and Family Welfare by Director General of Indian Council of Medical Research (ICMR) V. M. Katoch at a meeting here on Friday. The members took on Dr. Katoch and made numerous queries over the cervical cancer prevention vaccine trial.
The interim report, submitted in November, identified several deficiencies in the planning and implementation of the project that “led to the crisis requiring suspension of the study” but fell short of fixing responsibility on any individual or agency.
Dr. Katoch, who was carrying the voluminous final report with him to the meeting, told the committee members that the final report was received on Thursday and it was not much different from the interim report except that it had a large number of annexures. He told the members that the final report would be tabled before the Committee. The Committee has not been given even the interim report so far.
The Committee was set up on April 15 after the trials were suspended following reports of death of four girls in Andhra Pradesh, where the trial was conducted and violation of guidelines during the implementation of the project which provided free cervical cancer prevention vaccine to young women. The vaccines were provided free by two pharmaceutical companies – GSK and MERCK – through a non-governmental organisation PATH for the project titled, “A Post-licensure observational study of HPV vaccination: Demonstration Project'' carried out in collaboration with the State governments and the ICMR. The members of the committee were S.S..Agarwal, former Director Sanjay Gandhi PGI of Medical Sciences at Lucknow, S.P.Agarwal, former Director General of Health Services and Suneeta Mittal, All India Institute of Medical Sciences.
The health and women's organisations have already criticised the interim report and described it as unfortunate as it had failed to fix responsibility on any organisation or individual though it has admitted violations of guidelines at various levels during implementation.
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, according to Jan Swasthya Abhiyan. Given this, the slipshod manner in which the enquiry has been conducted raises very serious concerns, and reinforces the view that poor Indian subjects are being used as guinea pigs to test medicines developed outside the country, it said while quoting official figures that said that the incidents of trial related deaths in India had risen over the past few years and over 400 such deaths had been report between January and June last year.
