Human papilloma virus (HPV) vaccine trial killed girls in Andhra: trials without ethics

Human papilloma virus (HPV) vaccine trial killed girls in Andhra: trials without ethics

According to reports in the national and international press, a test conducted by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research, went completely awry. The final report submitted by the three-member committee appointed by the central government to investigate the alleged irregularities in the human papilloma virus (HPV) vaccine trial has shown clear evidence of gross ethical violations.

The test/clinical trial was conducted on 23,500 girls in the 10-14 years age group in Khammam district (Andhra Pradesh) and Vadodra (Gujarat). It is reported that seven children died after the trials and there was a five-month delay in reporting a death. Two deaths in Khammam district went unreported altogether, despite the fact that the whole point of a trial is to measure and report adverse effects after vaccination. In all these cases, the Principal and Co-Principal investigators failed to report all such events to the sponsor within a day, as required under the Drugs and Cosmetics Rules.

This report thus proves a total failure of the mechanism to monitor the ‘volunteers’ for both serious and non-serious adverse events following vaccination. According to an investigative news report the pharmaceutical industry’s strategy to cut R&D costs has created a $20-billion market for “contract research outsourcing [CRO]” of clinical trials. This market is projected to touch $35 billion by 2015.

What is happening increasingly is that CROs in developing countries are recruiting poor, illiterate test subjects through lures. This is how India is being touted as the testing ground of choice in the future, even though India’s share stands only at $500 million today.

Commenting on the manner in which the clinical testing was conducted, the committee condemned the “casual approach” taken towards informed consent documents, which are meant to guarantee that the test subjects, or their parents, understand the risks of participation have a right to refuse to participate. The committee discovered that these forms were filled in “very carelessly,” with “incomplete and probably inaccurate” information, according to the paper. In Andhra Pradesh, it was found that nearly 2,800 consent forms were signed by a hostel warden or school principal instead of parents.