Clinical Trials in India: The View From India

Here’s another story about clinical trials being conducted overseas. Except this time, I can’t refer to it as “outsourcing” (sending research out to another country) because here the story is being told from the point of view of the country bringing the research in.

From the Indian daily newspaper, Mid-Day: Study finds Illegal clinical trials in India:

Three MNC drug firms have conducted illegal clinical trials in India, says an investigation by Mumbai-based Centre for Studies in Ethics and Rights.

Drug major GlaxoSmithKline (GSK) has unethically tested a breast cancer drug on poor patients in India for approval for new drugs in the Europe Union, said a study.

The firm had tested lapatinib on patients flouting Indian Council of Medical Research’s (ICMR) ethical guidelines.

This trial required seriously ill patients who had not received treatment for their condition. GSK took advantage of the “vulnerable position” of breast cancer patients, said the study released last month….

The other two companies named in the story are Astrazenica and Johnson & Johnson (both accused of inappropriately using placebos in trials on patients with serious psychiatric conditions).

Now, it’s worth noting that, contrary to the headline and the story’s opening sentence, there’s no clear evidence of any illegal activity here. The research practices detailed certainly look highly unethical, but there’s nothing clearly criminal (though that doesn’t rule out civil liability of course). The word “illegal” might be being used because of a misunderstanding of the legal weight of the Declaration of Helsinki, which is mentioned in the story’s closing paragraphs. The Declaration isn’t legally binding; it’s force is moral, not legal. That’s not to minimize its significance, or to downplay the gravity of practices that violate it; but the distinction is typically thought an important one. But as this story perhaps demonstrates, from a certain perspective — perhaps the perspective of a commentator inside a developing nation — the difference might not matter much at all.

(Here’s the website for the Centre for Studies in Ethics and Rights; unfortunately, their “Studies” page seems to be password-protected.)

~ by Nancy Walton on March 18, 2009.

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