PHFI rejected HPV vaccine project proposal

Said it failed to state ethical aspects involved in the study

Hindu Times

Aarti Dhar
NEW DELHI, February 18, 2011

The proposal for conducting the now controversial “Post-licensure observational study of Human Papilloma Virus (HPV) vaccination: Demonstration Project,” carried out by a non-governmental organisation PATH for two major pharmaceutical companies, had been turned down by the Public Health Foundation of India (PHFI) as it failed to state the ethical aspects involved in it.

The PHFI had received the proposal for conducting the study from the Indian Institute of Public Health at Gandhi Nagar (Gujarat) but the Institutional Ethics Committee of the Foundation rejected it on the grounds that it was “based on the assumption that no ethical issues arise with regard to undertaking the HPV vaccine demonstration project.”

“It was based on an assumption that the vaccine was safe and efficacious,” Srinath Reddy, president of the PHFI told The Hindu adding that the ethical aspects of the study were not stated in the proposal.

Addressing a press conference here on Thursday, the Jan Swasthya Abhiyan and the All-India Democratic Women’s Association (AIDWA), and SAMA, said the interim report of the three-member committee, constituted by the Centre to look into various aspects of the project that had been suspended in April following the death of six girls, had let off the hook all those involved in the project by declaring the deficiencies in the project as “minor” and not “wilful or fully anticipatable” and stating that “since there does not appear to be any mal-intention, no responsibility could be fixed.”

Dangerous precedent

“Since violations have occurred at all levels of project, we demand that all involved must be considered culpable, and appropriate punitive action taken. To say that responsibility cannot be fixed on any one individual or organisation is a dereliction of duty, and a convenient excuse for irresponsible and unethical conduct, thus setting a dangerous precedent, Sarojini N. of SAMA, said.

Communist Party of India (Marxist) MP Brinda Karat who had raised the issue last year, said the government should take stern action against the wrongdoers. “There must be a further scrutiny of the role of the Drugs Controller General of India and the Indian Council of Medical Research as the primary institutions involved in the project. Appropriate action should also be taken against the NGOs concerned,” she said while demanding compensation for all the subjects who were victims to the vaccine programme without their consent.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.