Clinical Trials Going too Slowly? Subjects Want too Much Money? Think India.
Wired News evaluates the newly solidified market for testing drugs on the poor in India. They quote our own Sean Philpott:The sudden influx of drug companies to India resembles the gold rush frontier, according to Sean Philpott, managing editor of The American Journal of Bioethics."Not only are research costs low, but there is a skilled work force to conduct the trials," he said. In the rush to reap profits, Philpott cautions that drug companies may not be sensitive to how poverty can undermine the spirit of informed consent. "Individuals who participate in Indian clinical trials usually won't be educated. Offering $100 may be undue enticement; they may not even realize that they are being coerced," he said.
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There is a heated debate about whether or not offering poor people a (relatively) substantial amount of money to join a research study violates the idea of 'voluntary consent.' Is recruitment in such circumstances coercive? Would a prohibition against recruiting participants in such circumstances be unacceptably paternalistic? There is no consensus.
What I find more troubling than the potential coercion comes later in the Wired article:
"Also, critics say study volunteers may be taking risks without the potential for reward. Since many pharmaceutical companies are developing the drugs for markets in industrialized nations, it is unlikely that India's poor will have access to most of the new medicines."
- by Stuart Rennie on Dec 20, 2005 at 2:35 AM | link
There is a much more powerful and sinister reason pharmaceutical companies might want to conduct there studies in cash-poor countries. How much easier to cheat the results. Recent cases in the US and abroad have shed much light on the way some companies conduct their business - how much easier to conduct shoddy biased and selective research in countries where the legal contraints are fewer, Universities have even less power, and scientists involved have less international reputation to lose.
This past month or so has seen some striking examples or pharmaceutical science run amock:
The Blumjon case in England with P&G is well worth reading. One wonders whether we would even hera about these incidents if studies are carried out in India, China or Africa:
http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html
- by Beverley Bee on Dec 22, 2005 at 1:15 PM | link