Gardasil research targets girls from vulnerable communities

The Scavenger

September 12, 2010

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.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.