NEW DELHI—In another sharp blow for researchers hoping to conduct clinical trials in India, a parliamentary panel has excoriated a U.S. nonprofit and its Indian partner for alleged ethical violations in a trial of a vaccine to protect against cervical cancer caused by the human papillomavirus (HPV). The panel’s report “will have a freezing effect on all clinical research,” predicts epidemiologist Ramanan Laxminarayan, vice president for research at the Public Health Foundation of India in New Delhi.
HPV infection is a leading cause of cervical cancer; each year, nearly 73,000 women in India die from the disease—about one-quarter of the global disease burden. A vaccine against the virus has been available in the United States since 2006. Hoping to broaden the vaccine’s use in the developing world, the Program for Appropriate Technology in Health (PATH), a nonprofit based in Seattle, in 2009 launched a $3.6 million HPV trial, funded by the Bill & Melinda Gates Foundation, in 24,777 adolescent girls in Andhra Pradesh and Gujarat states. PATH conducted what it calls similar “post licensure demonstration projects” in Uganda, Peru, and Vietnam. But several months into the Indian trial, the government pulled the plug after news outlets reported the deaths of seven girls.
State investigations absolved the trial’s managers—PATH and the Indian Council of Medical Research (ICMR) in New Delhi—of responsibility in the deaths. Five were evidently unrelated to the vaccine: One girl drowned in a quarry; another died from a snake bite; two committed suicide by ingesting pesticides; and one died from complications of malaria. The causes of death for the other two girls were less certain: one possibly from pyrexia, or high fever, and a second from a suspected cerebral hemorrhage. Government investigators concluded that pyrexia was “very unlikely” to be related to the vaccine, and likewise they considered a link between stroke and the vaccine as “unlikely.” ICMR’s director general, microbiologist Vishwa Mohan Katoch, categorically rejects a connection: “Based on the enquiry, it is certain that causality of the seven deaths was not at all related to the HPV vaccine,” he insists. Other experts say that in the absence of autopsies, it is impossible to pinpoint the actual cause of death.