Calling for an immediate suspension of the ‘clinical trials' of the HPV (human papilloma virus) vaccine being conducted by a non-governmental organisation with the approval of the governments in Andhra Pradesh and Gujarat, Communist Party of India (Marxist) Polit Bureau member Brinda Karat on Wednesday demanded an impartial enquiry and action against those responsible for granting permission to carry out the trials for a pharmaceutical company.

The HPV vaccine, Gardasil, meant to prevent cervical cancer among women, has reportedly led to the death of four girls who were administered the dose in Khammam district of Andhra Pradesh. Over 120 girls, who were given the shots, have reported adverse side-effects.

The trials are being described as a “demonstration project” by PATH-International, a U.S.-based non-governmental organisation, which is conducting the project for American pharmaceutical company Merck since July 2009.

The girls, aged between 10 and 14 and belonging to the most vulnerable sections of society, were enrolled in the study approved by the Indian Council of Medical Research (ICMR) and the respective State governments, and is funded by the Bill and Melinda Gates Foundation.

The objective of the two-year study is to look into the “acceptability and service delivery issues” of Gardasil, marketed in India by MSD Pharmaceuticals.

At a press conference here — along with representatives of the All-India Democratic Women's Association (AIDWA), Saheli, Sama, All-India People's Science Network, and the Jan Swasthya Abhiyan — Ms. Karat accused the pharmaceutical company of misleadingly promoting the vaccine as preventive for cervical cancer as it prevented the cancer of only two strains of hundreds that caused cervical cancer.

“The literature circulated in the project makes outright false statements about its safety, efficacy and duration of effectiveness. The girls and their parents have been told through the project documents that the vaccine will give life-long immunity, has no side-effects other than minor ones like fever and rash, and would not affect future fertility of the young girls,” the speakers said at the press conference.

Drawing attention to the gross violation of informed consent of the “subjects” being used for the trials, Ms. Karat sought to know how the Drugs Controller-General of India granted approval to the vaccine without proper research in India.

She said:

“The process of licensing the vaccine in India raises many serious questions, as time and again scientific logic and the ethical guidelines have been violated at each step.

“Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults, and the vulnerable sections of society cannot be used for human trials.

“In this case, the children from the Scheduled Castes, the Scheduled Tribes and the Muslim communities, who are economically poor, were used for experimenting. A number of children were from families displaced from Chhattisgarh, who could not even understand Telugu.”

Ms. Karat demanded that each vaccinated girl be examined by an independent authority to assess the range and incidence of side-effects, and sought an enquiry into the use of the National Rural Health Mission (NHRM) logo on the vaccination card given to the girls, which was titled ‘HPV Immunisation Card.'

“The vaccination is not part of the universal immunisation programme of the country,” she said, adding that while PATH claimed it was a promotional programme for the vaccine in India, the ICMR had clarified that it was, indeed, a clinical trial.

She had written two letters to the Health and Family Welfare Minister and was awaiting a response.

After visiting some of the areas where the vaccine was administered, Ms. Karat had said the people were given to understand that it was an expensive vaccine and that they would not be able to afford it once the company's project was over, hence they should get their daughters vaccinated. Since the NRHM logo was on the card, the villagers went for the injection.

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