Nature News examines controversy surrounding Indian HPV vaccine trial

Jun 24 2011

After four teenage girls involved in a clinical trial in India testing vaccines for human papillomavirus (HPV) died last year, the study "threatens to have a dual legacy: inflaming unfounded fears about a lifesaving vaccine and raising new questions about the management of medical research in the country," Nature News reports.

"A committee of three scientists from the All India Institute of Medical Sciences (AIIMS) in New Delhi, commissioned by the government to look into the trial, confirmed that the deaths were not linked to the vaccines - two of the girls died of poisoning, one of drowning and the fourth of a fever. But its report, leaked to India's media last month, said that the study involved several serious ethical violations," including misclassifying the study as observational rather than clinical, the news service writes.

The study was run by PATH, an international health organization, and the Indian Council of Medical Research (ICMR), Nature News notes. "Vivien Tsu, director of PATH's HPV vaccines project, says that the procedures criticized in the report had all been approved by state ethics boards in India and an independent review board in the United States," according to Nature News, which adds that "Rani Kumar, dean of the AIIMS, who assisted the investigating committee, declined to speak to Nature."

"Still, the verdict could pose a setback to the country's ambitions to become a hub for international clinical trials, luring drug developers with its large patient population and low costs," according to the news service (Shetty, 6/22).