May 17, 2006

Gandhi Finally Gets Some Notice: Does Anybody Out There Wonder When India Will Rise Up Against Clinical Trials Abuse?

The The Sunday Times (London) picked up not only on the blog coverage here of the contrast between a few guys getting injured in a British voluntary drug trial and the horror that is unfolding in clinical research in India. This is our first citation in the Times London and they are the only paper to notice the column in The Scientist on Gandhi. Here's their coverage:
If you ever thought that taking part in drug trials seemed an easy route to modest riches, the preliminary experiments on human beings involving compound TGN1412 should have disabused you of that notion. This was the drug, made by TeGenero and trialed by the drug-testing firm Paraxel, that left six healthy men seriously ill, two of them close to death.

Although it was a public relations disaster for both companies, public enthusiasm for trials has long been dwindling, and not just among the healthy, who are first in the experimental firing line (before being used to make sick people better, scientists must ensure that potential therapies do not make healthy people sick). Even the ill are reluctant to entrust what little health they have to pharmaceutical companies. One study found that 71 per cent of cancer patients deemed eligible for clinical trials decline the opportunity.

That contrasts with a growing preference by the drug firms for larger trials, which tend to show up rare side-effects earlier. Bigger trials are seen as a way of preventing another Vioxx — an arthritis drug that was found, after licensing, to cause heart attacks and stroke. reports that compensating affected patients could cost the makers, Merck, $38 billion (£24.4 billion).

And so Big Pharma has begun outsourcing its trials to India, a move that, according to bioethicists, could create a “new imperialism”. India has huge numbers of sick people glad to test drugs in return for minimal, if any, recompense. The patients rarely mind — to them, experimental healthcare is better than none at all — and they rarely complain. India also has a homegrown supply of highly educated, English-speaking doctors, who cost a fraction of their Western counterparts.

AstraZeneca has opened a drug-testing facility in Bangalore; Pfizer has done the same in Bombay. At the moment one in a hundred global clinical trials is conducted in India, but Oxygen Healthcare, a British consultancy, estimates that in five years’ time that figure will have risen to one in ten. This makes financial sense but others are clearly worried that poor, illiterate patients are being exploited. There is certainly doubt over whether they are giving informed consent. The Indian Journal of Medical Ethics reports that patients are often unable to distinguish between trials that might benefit them and those that won’t. Another study pointed out that, of the country’s 14,000 general hospitals, fewer than 200 are equipped to carry out drug trials adequately.

Indian patients are often used to test medicines that, once marketed, they will not be able to afford.

The editors of the American Journal of Bioethics say in their blog that “pharma trials in India should be the focus of a huge amount of attention in the world of research ethics”. Even more forthright was a recent opinion piece in The Scientist. “If Gandhi were alive today, he would lead protesters to the doors of a clinical research trials facility, where the oppression of the Indian poor dwarfs that of the 1930s.” This is a reference to Gandhi’s march against the British salt tax, which made it illegal to obtain salt from anyone other than the British Government, even though it could be collected along the coast. Gandhi and his supporters marched 240 miles from western India to coastal Gujarat, gathering the mineral on the way. The march ended in a bloody confrontation at a salt factory.

The Indian Government now stands accused of colluding in this new oppression. In 2004 it stipulated that drugs tested in India should first be proved safe in their country of origin; in 2005 the law was revoked.

This issue deserves close inspection but we should beware a knee-jerk cry of “exploitation”. The most rational thing to do is to look at the equation of exploitation: does the drug company benefit unfairly from its interaction with the patient? If so, then perhaps The Scientist is justified in asking: “How long before the people of the nation of Gandhi rise up to reject a new imperialism?”

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