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Resource centre on India's rural distress
 
 

HPV vaccine: AIDWA for action against rights violators

-The Hindu
 
Consent forms signed by higher authorities on behalf of adolescent girls

‘Interests of NGO, business prioritised over that of people'

Due attention was not paid to the adverse side effects and vaccine-related problems

Expressing concern over the “shocking” irregularities and violation of medical ethics in the Human Papilloma Virus (HPV) vaccine trial, revealed by the final HPV enquiry report and its findings, the All-India Democratic Women's Association (AIDWA) has demanded fixing accountability and ensuring action against those at fault.

In a statement issued here on Thursday, AIDWA said the three-member expert sub-committee that assisted the inquiry ordered by the Health and Family Welfare Ministry into complaints against the HPV project has clearly underscored the widespread violation of ethical norms. It is indeed disturbing that despite glaring evidence of rights violations, collated in detail by the experts, the report has neither apportioned responsibility nor recommended any action against those responsible for the lapses. The AIDWA demanded that the government examine the expert findings seriously.

Questioning the collaboration between a private body and the Indian Council of Medical Research in a project with questionable objectives, AIDWA said PATH — an international NGO — had undertaken a study for two American pharmaceutical companies, producing/marketing the expensive HPV vaccine. Evidently, the 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 said.

The second alarming aspect relates to how the project was implemented and consent 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 — in Andhra Pradesh and Gujarat, with the consent forms duly signed by the hostel wardens, represents a gross violation of rights as students could not possibly have objected to the higher authorities' instructions, the AIDWA statement said.

Due attention was not paid to the adverse side effects and vaccine-related problems while conducting the trials.