Expressing concern over “shocking” irregularities and violation of medical ethics in the Human Papilloma Virus (HPV) vaccine project trial as revealed by the final HPV enquiry report, the All India Democratic Women’s Association (AIDWA) has demanded action against those at fault.
In a statement issued in New Delhi on Thursday, the AIDWA has said the three member expert sub committee that assisted the enquiry set up by the Health and Family Welfare Ministry to enquire into complaints regarding the HPV project has clearly underscored the widespread violation of ethical norms.
It is indeed disturbing that despite glaring evidence of human rights violations collated in detail by the experts, the report has not apportioned responsibility nor has it recommended any action against those responsible for the lapses. The AIDWA demands that the government should examine the expert findingsseriously, fix accountability and ensure action against those at fault.
Questioning the very collaboration between a private body and the Indian Council of Medical Research, in a project with questionable objectives, AIDWA has said PATH - an international NGO - had undertaken a study fortwo American pharmaceutical companies producing and marketing the expensive HPV vaccine. Evidently, ICMR guidelines and protocols designed to provide safeguards for research subjects were breached right from the inception stage.
“It is a matter of concern that the interests of the NGO, and the business interests of the companies that it represented, received greater priority, while the interests of the Indian people were marginalised. The report brings out the facts clearly. The so called “post licensure observation study”, has been found to be no less than “a clinical trial on human participants” by the experts,” the statement has said.
The second alarming aspect relates to the way in which the project was implemented, and consent was obtained from the “human” objects of the study. In June 2009, an official circular issued by the Andhra Pradesh government instructed the authorities to sign the consent forms on behalf of the adolescent girls. The vaccination of as many as 23,000 girls - mainly tribals – from Andhra Pradesh and Gujarat, with the consent forms signed by the hostel wardens represent a gross violation of rights, as students could not possibly have objected to instructions from higher authorities, the AIDWA statement said.
A related lacuna was that due attention was not paid to the adverse side effects and vaccine related problems while conducting the trials. Furthermore, despite the existence of contraindications for the use of the vaccine, there were no checkups for contraindications before the girls were vaccinated.
The third disturbing feature has been the attempt to gain credibility for the project by placing it alongside the public health programmes of the government. The use of the NRHM logo for a programme that was being carried out by a private agency was most reprehensible.
The HPV enquiry report shows a damaging and disturbing contravention of existing safeguards and norms that have been built up over the years, the statement added.