HPV clinical trial proposal rejected

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Copied as fair use from mail of our member Dr Amar Jesani.

Vijay

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The Hindu, NEW DELHI, February 18, 2011

PHFI rejected HPV vaccine project proposal

Aarti Dhar

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.

Ms. Karat has also written to the Union Health and Family Welfare Minister

Ghulam Nabi Azad in connection with the interim report pointing out that there

was nothing minor about the various deficiencies noted by the committee.

These were major violations and exoneration of those responsible would set a

dangerous precedent. Indeed the committee members had not done any credit to

their reputation by such an " outrageous'' recommendation, she said.

Aim to influence government

The committee, perhaps, in spite of itself and the many acts of omission and

commission in its report has raised serious issues about the project.

" Regardless of the intention there was a conflict of interest and all the

deficiencies in the design of the project as well as the conduct of the project

could have been precisely because the main aim was to influence government to

include the vaccine in the public health programme,'' she said.

" Despite stating the fact that the vaccine for the study was provided by

manufacturers free of cost does raise the concern about undeclared conflict of

interest since the results of the study may be used to influence the decision by

the government, the committee fails to build upon this significant and alarming

aspect, " Ms. Karat said.

Quoting from the report that more than a quarter of clinical trials in the world

were now being conducted in India, Jan Swasthya Abhiyan said concurrently the

Ministry of Health and Family Welfare claimed that there had been a manifold

rise in the number of deaths among clinical trial subjects in the past few

years.