The HPV Vaccine: Science, Ethics and Regulation

Economic & Political Weekly

November 27, 2010

Sarojini N B, Sandhya Srinivasan, Madhavi Y, Srinivasan S,
Anjali Shenoi

Sama- Resource Group for Women & Health

A recent civil society-led investigation has highlighted serious ethical violations in a trial of the Human Papilloma Virus vaccine on girls in Khammam district in Andhra Pradesh. The findings are presented along with
a review of clinical trials of the hpv vaccine in India and an analysis of the Drugs and Cosmetics Act and Rules.

Together they illustrate how the promotional practices of drug companies, pressure from powerful international organisations, and the co-option of, and uncritical endorsement by, India’s medical associations are influencing the country’s public health priorities.

On 7 April 2010, the government called a halt to trials of the Human Papilloma Virus (HPV) vaccine in the country. According to a press report, “In the wake of reports of violation of ethical guidelines and exploitation during the ‘clinical trials’ of HPV (Human Papilloma Virus) vaccine, meant to prevent cervical cancer among women, the Centre on Wednesday advised the state governments to suspend the vaccine programme until the issue is settled” (Dhar 2010a).

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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.