India’s Inquiry Finds Evidence of Ethics Violations in Clinical Trial

India’s Human Papilloma Virus (HPV) vaccine trials came under attack after reports of ethical violations. A committee that investigated the claims proved that there ‘were large-scale ethical violations during the conduct of post-licensure observational study’

According to WHO, cervical cancer is the most common type of cancer in India where it kills 74,000 every year. In 2007, PATH International signed a memorandum with India Council of Medical Research (ICMR) for a project to introduce HPV vaccine in India. The project was to be funded by Bill and Melinda Gates Foundation, the vaccines provided by Merck’s and GSK,  and the protocol was written by ICMR. Young girls between the ages of 10-18 years from underprivileged socioeconomic status were recruited for the project with the claim that they cannot afford paying for the expensive vaccines.

The civil societies complained of ethical transgressions and the death of 4 girls enrolled in the trials. On its website, PATH-International failed to point out the deaths of the 4 girls in its update about the project on April 27 , 2010,  but their deaths were reported by India’s National Newspaper earlier on  April 8 of the same year. The project was only halted when the deaths toll increased to 6.

An independent inquiry committee was formed of ‘S.S. Aggarwal, former director of the Sanjay Gandhi Post-graduate Institute of Medical Sciences, S.P. Agarwal, former director-general of health services, and Suneeta Mittal, head of obstetrics and gynaecology at the All-India Institute of Medical Sciences (AIIMS) in New Delhi’. In addition, three subcommittees were established to assist in the inquiry.

The violations reported ranged from improper consent process, safety concern,s and deficient adverse events reporting. The girls were chosen from a vulnerable population of tribal areas in India’s Maharashtra, Tamil Nadu, Gujarat, Andhra Pradesh, Haryana, Sikkim and Mizoram States according to the report. The consent form itself was vague and implied a degree of inducement and coercion. Moreover, the girls were administered an intervention that was not part of the protocol and the trials lacked an independent monitoring system, which led to delayed adverse events reporting. Lastly, the report recommended an independent legislative committee that would support and endorse the ICMR guidelines.



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