Four adolescent girls died due to lack of follow-up observation

Communist Party of India (Marxist) Polit Bureau member Brinda Karat on Thursday demanded action against those responsible for allowing clinical trials of the human papillomavirus (HPV) vaccine in Andhra Pradesh and Gujarat without following the guidelines and ethics.

Speaking at a seminar organised by the All-India Democratic Women's Association (AIDWA) here on “Cervical Cancer Vaccine — Consequences” the CPI(M) Rajya Sabha member said the poor in the country were used as guinea pigs by two multinational pharmaceutical companies for clinical trials of their unproven vaccine in the name of a demonstration project.

Ms. Karat slammed the Indian Council of Medical Research (ICMR), the Drugs Controller General of India (DGCI) and the Ethics Committee at the national and State-levels for permitting vaccine trials without any proof of its efficacy or studies on their side-effects. “All established protocols of biomedical health research were violated in the trials of HPV vaccine,” she alleged.

Seeks compensation

The after-effects of the vaccine proved fatal for four adolescent girls as there was no follow-up observation, she noted and demanded compensation for the victims' families and an end to the trials till the vaccine's viability was proved. Reports of a three-member inquiry committee that went into the vaccine trials had stated that “the project was carried out as research on human participants and its monitoring should have been more vigorous.”

Punishment of those responsible was the only way to prevent such trials in future, Ms. Karat said. She sought to know why the government was not acting on the experts committee report. She was also critical of the Andhra Pradesh government for asking school headmasters and wardens/matrons of hostels to give consent for vaccine administration on behalf of the girls' parents.

‘Irresponsible'

Commissionerate of Health and Family Welfare Joint Director here N. Balaramaiah said the vaccine trials were irresponsible as no awareness was created among the concerned. Anjali, an RTI activist alleged that the Centre was planning to include HPV vaccine into the country's universal immunisation programme at a cost of about Rs.11,250 crore per annum, though it was unable to immunise all children even with basic vaccines like DPT.

AIDWA general secretary Sudha Sundararaman said the vaccine was tried on about 23,000 adolescent girls.

Venkatamma, mother of Sarita, who died after taking the vaccine, and a few others of the Bhadrachalam area, where the trials were conducted, narrated their experience with the vaccine.

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