“Include public health experts in clinical trials”

Communist Party of India (Marxist) MP Brinda Karat has expressed dissatisfaction with the three-member committee set up by the government to look into the alleged violation of guidelines for conducting “clinical trials'' of human papillomavirus (HPV) anti-cancer vaccine by a non-government organisation (PATH) for a U.S.-based pharmaceutical company. The project is funded by the Bill and Melinda Gates Foundation.

Letter to Azad

“The committee that includes a former government official and a serving doctor may not serve the purpose of independent enquiry. I would request you to include well-known public health experts, people from the social sector as well as those involved in studies regarding violation of ethical guidelines in clinical trials,” Ms. Karat has said in a letter to Health Minister Ghulam Nabi Azad.

“The committee presumably will be dealing with the violation of ethical guidelines by government officials and institutions, including investigating the role of senior officials perhaps even more senior than those in the committee. It is also necessary to inquire into how the office of the NRHM [National Rural Health Mission] is used for the project which is not in its mandate.

The committee members — S.P. Agarwal, former Director-General of Health Services; Sunita Mittal, head of the Department Obstetrics and Gynaecology at the All-India Institute of Medical Sciences; and pharmacologist Ranjit Roy — have been asked to submit their report within two months.

Ms. Karat wrote to Mr. Azad twice earlier drawing his attention to the alleged violation of guidelines by MSD Pharmaceuticals in conducting the trials through an NGO in Andhra Pradesh and Gujarat.

Fundamental question

“I had raised a fundamental question on the nature of the programme. This was in the context of the differing statements given by the concerned officials to me. More recently, both the Secretary of the Ministry and the Director of the Indian Council of Medical Research are on record in an official meeting that the programme is a ‘clinical trial.' I am, therefore, surprised that you have stated categorically that it is not a clinical trial but ‘an operational research study.'

“Elsewhere in the annexure it is referred to as a ‘demonstration project.' Are these the same and what are the definitions? On a perusal of the ICMR literature and guidelines, I find that there is no such category listed as ‘operational research.' The NACO [National AIDS Control Organisation] guidelines use this term, but with the same protocols as clinical trials. Of late, some internationally funded health medical researchers representing pharma companies are using this term to provide a reason for not seeking ethical approval for a study on the grounds that it does not involve primary research. I hope you will clarify this issue,” she said.

Conflict of interest

“Another issue which unfortunately has not been addressed in your letter is the conflict of interest involved in the PATH project. This NGO is a partner of the manufacturing company MERCK in other projects.

“As a partner, it can be easily understood that the conflict arises from the interests of the subjects of the project, in this case children, on the one hand, and the vaccine manufacturer, on the other.

“If there is not to be a cover-up of what appears prima facie to be a case of connivance with a vaccine manufacturing company in violation of set guidelines, I would once again request you to kindly look into the aspect of the inquiry, both in its terms of reference and in its composition.”