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December 19, 2008

On Research in Developing Countries

Despite my total lack of surprise, I am still outraged at some of the news coming out regarding the practices of clinical research in India.  Ed Silverman, at the indispensable Pharmalot, notes:

The race to test drugs in India, where costs are lower and patients are plentiful, is creating a vast cottage industry of doctors and contract research operators, but a dearth of oversight and ethical standards [. . . ]

Silverman references a series of articles on the subject written in the St. Petersburg Times.  Some highlights from the main Times article:

In the past three years, the FDA has inspected just eight of the thousands of trial sites in India.

In the burgeoning clinical trial business, says Amar Jesani, a doctor and medical ethicist in Mumbai, every layer of oversight is compromised by cash, and independent monitoring is nonexistent. He has resigned from supposedly independent ethics committees that rubber-stamp drug companies' proposals and overrule any objections.

Dr. S.P. Kalantri has conducted trials for global pharma at the government hospital in Sevagram, a small town in central India. But he said he has pulled back from doing the studies.

"It's difficult to explain the complexities of trials to study participants,'' Kalantri said of the hospital's mostly poor, illiterate patients. "I think many investigators tend to take their patients for a ride. And there's an abysmal lack of know-how about clinical research among investigators."

• • •

On the ground in India, it is impossible to find anyone running, monitoring or auditing clinical trials who is not on the payroll of the drug makers.

Doctors are paid according to the number of patients they enroll. Local ethics boards, set up to ensure patient safety, are often comprised of colleagues who approve each others' projects and blackball naysayers.

C.J. Shishoo, former dean of India's oldest pharmacy college, runs an independent ethics committee in Ahmedabad. He lost the business of two big clients when he objected to how they were running their studies.

"They just went elsewhere,'' Shishoo said of the drug companies he alienated. "I'm very much concerned. Life here is a little cheap."

I think academic detachment is not the appropriate response to this kind of information.  In part, my outrage, which again, I feel despite a total lack of surprise at these findings, is borne in part out of a concern for the social, cultural, and health related ills that flow from structural inequities and practices, past and present, that represent political and economic choices made by Western countries, communities, and institutions.

That is an intentionally provocative statement, but it builds on a great deal of work (mine and others) regarding the idea that problems of justice and population health, globally and locally, are largely traceable to social and economic conditions that are in turn the products of choices made and not made by any given community and society.  On the global level, I find Amartya Sen's work on this most eloquent and persuasive, though Paul Farmer's writings are also instructive.  And in the recent talk given by Sir Michael Marmot, he states that part of the point of the WHO CSDOH Report is that these conditions are in fact the product of political choices made.

The ethical aspects of many of these choices are highly contestable -- indeed, a fundamental characteristic of public health policy in general is that it is virtually always contested (Stone 2002).  The ethically optimal choices are rarely facile and obvious; ethics is hard.  But what outrages me about what is going on in India is that the ethics do not seem quite so difficult, especially given the terrible history of colonialism on the subcontinent.

(If you are not aware of what happened in Bhopal, India, please read, as it is relevant, IMO).



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