Health ministry yet to initiate action on violations in trials of HPV vaccine in AP and Gujarat

By Joseph Alexander, New Delhi

Ethics Violations?

Even after several months since the expert committee found irregularities in the clinical trials of Human Papilloma Virus Vaccine (HPV vaccine) that allegedly caused deaths of a few trial subjects, the authorities are still sitting on the report and failed to initiate any punitive action.

According to a status report on the violations in clinical trials during the past few years, the controversial trial was listed by the Health Ministry among the violations but said ‘the report was still under examination.’

“This was a phase-IV post licensure clinical trial. The trial was initiated by PATH (Programme for Appropriate Technology in Heath), an NGO. The Indian Council of Medical Research (ICMR) and the State Governments of Andhra Pradesh and Gujarat were the collaborating partners. 14091 girls received the vaccine in Andhra Pradesh whereas 10686 girls received the vaccine in Gujarat,” said the report.

“Media reported death of 7 girls during the trial. The trial was suspended by ICMR on 7th April 2010. A Committee was appointed to enquire into the alleged irregularities in the conduct of studies using HPV vaccine by Path in India. It reported certain discrepancies in the conduct of the trial. The PATH submitted clarifications in respect of irregularities observed in the conduct of trial which is under examination,” it said.

After the expert panel submitted the report, the government in May last had allowed the third phase of clinical trials in India but without further vaccinations, notwithstanding the demands by public interest organisations and political leaders to initiate stern action.

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