Clinical Trials

The HPV Vaccine: Science, Ethics and Regulation
– Sarojini N B, Sandhya Srinivasan, Madhavi Y, Srinivasan S, Anjali Shenoi

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.

Source: Economic & Political Weekly, November 27, 2010, Vol XLV No 48, 27-34

Undeniable Violations and Unidentifiable Violators
Sarojini N, Anjali Shenoi, S Srinivasan, Amar Jesani

The Human Papillomavirus vaccine “demonstration projects” conducted by a United States non-governmental organisation in collaboration with the Indian Council of Medical Research were suspended by the central government in 2010, following the deaths of seven tribal girls and pressure from civil society groups. An enquiry committee constituted to look into the “alleged irregularities” in the conduct of these projects has given its final report. Despite evidence of clear violations, however, the committee has absolved all involved in the project of responsibility.

Source: Economic & Political Weekly, June 11, 2011, Vol XLVI No. 24, 17-19

Drug Promotion, Clinical Trials and Conflicts

“Gifts buy you time with a doc, time that might change his mind….. Money is the big resource. The pads and pens are great for access, but the dinners and what costs money. CDs, handheld computers, everything given in the name of research this is what’s thrown at docs to get them to change their minds.” A Former Detailer.

Drug industries lobbies do not appreciate people who squeal……… READ THE FULL ARTICLE

Ethics on trial

Five per cent of the clinical trials conducted across the world will be in India by 2012. They are vital for confirming the efficacy of a new drug, but compromise on ethics. While doctors and organisations conducting trials make big bucks, the rights and safety of the subjects are often overlooked, says Ankur Paliwal.

Read the full article in Down To Earth (June 30, 2011).

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