Outsourcing clinical trials to India -- human guinea pigs?

[Emillereid]

India's clinical trials and tribulations
By Indrajit Basu

KOLKATA - The potential is huge, multinationals are willing and Indian companies are eager. Moreover, it is a type of outsourcing that is not likely to draw the protests of the anti-outsourcing brigade in rich economies. Yet even as India increasingly emerges as a preferred destination for outsourcing clinical trials - testing of new drugs on humans - the country may also be heading toward providing the greatest source of human guinea pigs for the global drug industry.

A spate of unfortunate events over the past few years has brought to the fore the rampant practice of conducting unethical and even illegal clinical trials in India, which is fueling immense concerns culminating into a huge public outcry over the regulatory authorities' failure to check such practices, and even lawsuits.

For instance, in early March, the Supreme Court of India hauled up two top biotech companies in India, the Hyderabad-based Shanta Biotech and Bangalore-based Biocon India, for "openly conducting illegal clinical trials of new drugs on unsuspecting patients" after a litigation filed by the Aadar Destitute and Old People's Home, a Delhi-based social organization. This non-governmental organization (NGO) alleged that the two companies had conducted improper clinical trials of Streptokinnese - a new clot-busting drug used in heart attacks - last November without requisite permissions (of the Genetic Engineering Approval Committee), as a consequence of which eight people lost their lives.

Although the Streptokinnese case was a shocking revelation, it wasn't an isolated one. According to Monthly Index of Medical Specialities in India, an independent pharmaceuticals journal, more than 400 women who had been trying in vain to conceive were enrolled in 2003 without their knowledge or consent to take part in clinical trials across India to see if a drug called Letrozole induced ovulation. Letrozole used in India was copied (with permission) by Sun Pharmaceuticals, a large Indian generic drug company, from a patented product of the same name of Novartis, which the multinational drug maker introduced globally for solely treating breast cancer and not for any other use in any country, including India. A complaint on the Letrozole case, too, was filed in the Supreme Court by yet another Delhi-based NGO. ...more...

What's next, mining human body parts in poor countries? I personally fear for the human race; our potential for inhumanity seems boundless some days.

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1. Tragic

Though this really isn't surprising, it's pretty tragic.

Perhaps Kerry and a new congress will reign in the drug companies.

All of a sudden, the topics addressed in Robin Cook's various medical mysteries aren't so far fetched at all.