Salt in the Wound

Will India rise up against the oppression of foreign clinical trials?

By | April 1, 2006

In March 1930, Mohandas Gandhi set out from his ashram in western India on a 387-km trek to the sea. Twenty-five days later the tens of thousands who joined that march watched as he stooped, raised a handful of salty mud, and declared the end of British imperialism in India. The march culminated as Gandhi led nonviolent protesters to the doors of the salt factory in Dharasana, where they attempted to push their way into the facility without weapons or raised fists. On that hot day hundreds were beaten, a spectacle that would make its way into newspapers worldwide and change the face of India forever.

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. Why? Not because Gandhi was a Luddite, a man who held meetings while spinning thread. And not because many of the excellent research institutions that have led India into its embrace of multinational bioengineering and medical research bear his family name.

No, the problem for Gandhi would be the outsourced clinical trials that have enrolled tens of thousands of Indians in a $1 billion business aimed not at the improvement of Indians' health or technology, but at providing deep discounts to pharmaceutical companies in other nations.

It is a perfect storm: The number of open slots in clinical trials around the world increases, the number of Americans willing to enroll in such trials lags (as few as 1.7% of patients with cancer), and the cost of clinical trials in India is half that in the United States. It is no surprise that American and European pharmaceutical companies are fanning out across the second most populous nation in the world.

Physicians in India report that a largely illiterate subject population, entirely unclear about risks and benefits, asks only one question: Doctor, should I enroll? At least one study in the Indian Journal of Medical Ethics reported that many Indian research subjects are utterly unprepared to distinguish between trials likely to provide benefit and those that will not (see www.issuesinmedicalethics.org/141cv013.html). According to a 2005 report in New England Journal of Medicine, fewer than 200 of the 14,000 general hospitals in India are capable of conducting clinical trials adequately.

Why do Indians, most of whom are poor, flock to clinical trials? One reason is that most of the nation is served by small and ill-equipped hospitals. The "chambers of commerce" for clinical trials in India point to the advantages of this fact: Indian patients are often untreated, reducing the number of confounding factors in study of medications. And a tiny payment, by US standards, to an Indian enrollee in a clinical trial could amount to three months' wages or more. Incentive payments to physicians for enrolling research subjects are also amplified greatly by the exchange rate.

The government attempted in 2004 to rein in unsafe international clinical trials by insisting that drugs tested in India must first be proven safe in their country of origin. But that law was eliminated in 2005, followed closely by an avalanche of new trials. Concerns about trials that are designed to demonstrate nominally important data, are poorly designed, or are just plain unsafe abound. Some trials are conducted on humans without prior animal studies having been performed. In one unapproved clinical trial for example, 435 women were given an anticancer drug to treat fertility, but did not know the drug was not cleared for this use.

The same imperialism that supported the salt factories of Dharasana in 1930 today manifests itself in Mumbai, Sevagram, and around India, where clinical trials too offensive for American research subjects are proffered to a billion residents of the nation Gandhi fought so hard to emancipate. How long before the people of the nation of Gandhi rise up to reject a new imperialism?

Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.

gmcgee@the-scientist.com

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