HPV vaccine: Groups demand action

Nimisha Jaiswal and Ishika Chawla Delhi

"ICMR (Indian Council of Medical Research) is party to the agenda of a foreign NGO to promote the interests of the manufacturing brand. This brings the ethics of ICMR into question," said Brinda Karat, Rajya Sabha MP and CPM leader. 

"We demand that the Union health ministry take strong action against ICMR, Drugs Controller General of India (DCGI) and the ethics committees for the institutional dereliction of duty," she added. She was speaking at a press conference in Delhi called by Jan Swasthya Abhiyan, Sama-Resource Group for Women and Health and Human Rights Law Network among others.

Earlier, the Human Papilloma Virus (HPV) vaccine trials conducted by American NGO PATH in collaboration with ICMR were suspended by the Ministry of Health and Family Welfare after opposition from human rights, child rights and women's health groups. An Enquiry Committee comprising three members was instituted on April 15 2010, to look into the alleged irregularities in the conduct of trials.

While the committee approved the project's protocols despite finding serious ethical violations, the other three expert members who were consulted by the committee brought forward important questions pertaining to the ethics of the trials. However, these questions and resulting findings were overlooked in the final report. 

Dr Amar Jesani of the Indian Journal of Medical ethics pointed out the five key 'deceptions' in the whole process- the nature of research, the portrayal of it as an 'immunization project', the dicey information in the consent forms, the false information that the girls volunteered to participate when many were in fact, recruited, and the deception of the ethics committee by the investigation panel.

ICMR, the premier research body of India which formulates guidelines for research, took up the Public Private Participatory (PPP) mode in research for the first time in this project.

At the conference it was demanded that:

1. The DCGI be held accountable for the approval and licensing of such a study that was severely lacking in several clinical trial protocols as is required by the Drugs and Cosmetics Act and the ICMR's Ethical Guidelines on Biomedical Research on Human Participants.

2. The multi-level violations particularly with regard to the selection of the study area, the lacunae in the research instruments, etc., - reflect the fact that the ICMR and its bioethics committees have been extremely lax in its role as technical supervisors and advisors. Furthermore it also casts doubts on the objectivity, seriousness and thoroughness of the members of the advisory group and ethics committees who gave their approval to these projects without critically examining the protocols. Immediate action should be taken against all members of these committees along with those ICMR officials who were responsible for and associated with these projects.

3. Given the active engagement of the State governments and machinery in the implementation of the projects, immediate action must be taken against all those involved and further safeguards be put in place at the policy level to pre-empt such forms of exploitation in the future when similar projects run through public private partnerships.