Big Pharma & Drug Trials in Developing Nations

From the current issue of Wired: A Nation of Guinea Pigs, by Jennifer Kahn.

This is a story about drug companies conducting clinical trials in South Asia, using tens of thousands of poor Indians as “guinea pigs.” It’s sort of The Constant Gardner, minus the violent killings.

The key ethical aspects of the story:

  • Drug companies pay hospitals and doctors to enroll patients in drug trials. The potential for conflict of interest is clear: hospitals and doctors, far from wealthy themselves, may succumb to financial temptations to enroll patients inappropriately. Of course (and with a few important differences) the same worry applies here in North America.
  • Most of the people being enrolled in trials are poor, illiterate, and culturally deferential to doctors. Their ability to give free and informed consent is questionable.
  • Most of the drugs being tested are drugs that are irrelevant to the health needs of a nation like India; they’re mostly medicines (like blood-pressure drugs) aimed at the North American & European markets.

One final element of this story needs explanation. The author points out a couple of times that sometimes people get enrolled in drug trials ‘even though the trials won’t help them.’ That sounds shocking, unless you know that clinical trials are never intended to help the test subjects who are enrolled in them. The idea that clinical trials are supposed to benefit those enrolled is what my colleagues in Bioethics call “Therapeutic Misconception.” The real goal of clinical trials is actually to answer a scientific question: “is this new drug effective?” or — preferably — “is this new drug better than the old way of treating this disease?”
So, while there are LOTS of ethical concerns when it comes to conducting drug trials in developing countries, the possibility that such trials “might not help” the test subjects is not one of them.
Update: This blog entry was excerpted in the “Rants & Raves” section of the May 2006 issue of Wired.

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