By: N B Sarojini and Anjali Shenoi
12 September 2010
During July and August 2009, the Andhra Pradesh and Gujarat governments, in association with the Indian Council of Medical Research (ICMR) and the Program for Appropriate Technology in Health (PATH), launched what they described as a ‘demonstration project’ for vaccination against cervical cancer.
Vaccines against the Human Papillomavirus (HPV) were administered to 13,791 girls in Khammam district in Andhra Pradesh, and to 9,637 girls in Vadodara district in Gujarat. The girls were between the ages of 10 and 14.
In Andhra Pradesh, the vaccine administered was Gardasil, manufactured by Merck Sharpe & Dohme (India) Pharmaceuticals Private Limited (MSD), the Indian subsidiary of US-based pharmaceutical company Merck & Co. Inc.
In Gujarat, Cervarix, manufactured by GlaxoSmithKline Biologicals (GSK) of Rixensart, Belgium, was administered. Both vaccines were approved for marketing in India in 2008.
As part of a four-nation initiative against cervical cancer beginning in 2006, PATH has launched ‘demonstration projects’ for the HPV vaccination in Peru, Uganda, Vietnam and India, using a grant of $27.8 million from the Bill and Melinda Gates Foundation.
Women’s groups, health networks, human rights groups and child rights groups in India have been voicing concerns about the safety, efficacy and public health value of the two HPV vaccines since they were first announced.
Many joint memoranda enumerating these concerns have been submitted to the Union Minister for Health and Family Welfare, demanding an immediate halt to the ‘demonstration projects’.
On April 22, 2010, the Ministry of Health and Family Welfare (MOHFW) finally conceded that the HPV vaccination project was in fact a “post-licensure operational research study.”
Further investigation confirmed it as a Phase IV, post-marketing clinical trial. On April 29, the ICMR admitted that their ethical guidelines had been flouted in the course of this trial.
The trial has been temporarily suspended by the government, and a committee has been formed to conduct an inquiry. According to V. M. Katoch, ICMR Director-General:
“This is not a phase-3 clinical trial but a post-licensure observational study as the vaccine —Gardasil by MSD Pharmaceutica l— is approved for use in India. ICMR just evaluated the study’s protocol and methodology. The state has to monitor ethical compliance but following the objection we have asked Andhra to suspend the program till a review is done.”
This paper reflects observations made by a fact-finding team of women’s rights and health activists from Sama, Jan Swasthya Abhiyan and Anthra, who visited the Bhadrachalam project site in Andhra Pradesh.
Their investigation revealed the so-called ‘demonstration project’ to be a calculated, multi-level violation of all existing protocol on clinical trials, as well as a glaring breach of child rights.