Wednesday, March 01, 2006

Clinical trials, outsourced


Wired has a pretty grim story (titled, appropriately, "A nation of gunea pigs") about clinical trials outsourced to India. The story, by Jennifer Kahn, does a pretty good job of raising the ethical issues behind this outsourcing wave. The most important issue, however, is the lack of awareness among poor, uneducated patients that does not allow them to make an informed choice about their participation in the trials. Some excerpts:

Last year, the government took a more controversial step, amending a long-standing law that limited the kind of trials that foreign pharmaceutical companies could conduct. That law allowed companies to test drugs on Indian patients only after the drugs had been proven safe in trials conducted in the country of origin. In January, the government threw out that constraint. India, the brilliant hub of outsourced labor, was positioning itself in a newly lucrative role: guinea pig to the world.

[...]

Little by little, however, Kalantri began to see the problematic side of outsourced trials. "When I try to explain that a drug is experimental, that it might not work, the understanding is not there," he observes. "One woman said to me, 'What do you mean, the drug might not work? All drugs work!'"

Poorly paid doctors can also find the financial rewards of a trial hard to resist - particularly since pharma companies reward high enrollments with prizes like vacations to Hawaii and Europe. "A lot of private hospital doctors have suddenly become 'researchers,'" Kalantri notes. "They will enroll almost anybody and recruit for almost any trial, whether or not it helps the patient." And while the money earned from a trial in Sevagram goes to the hospital, elsewhere it may be paid to the doctor. "A lot goes into personal bank accounts," he says.

4 Comments:

  1. Sowmya said...

    A while ago I read about how people from the US were coming to India for various kinds of surgeries, some of the not approved by the FDA in America, while Indian doctors could perform the same in India. The patients were very happy with the outcome. Here is the link

    Making Indians guniea pigs is really sad.

  2. Veena said...

    The Constant Gardener Redux, I guess.

  3. anantha said...

    *echoes Veena's comment!

    You have to watch The Constant Gardener!

  4. Abi said...

    Sowmya, Veena, aNTi: Thanks for your comments. I guess I will look for a chance to get this movie. If I do see it, it will be the first movie in a loooooong time!

    Coming back to the Wired story, Jennifer Kahn is careful to lay out the issues from the points of view of all the sides. In particular, she makes it clear that progress in medicine has always required gunea pigs; it is not unreasonable to expect most of the experimental subjects to be in a helpless or hopeless condition who are willing to try something, anything.

    However, do we have laws (and the capability to enforce them) that will prevent unscrupulous doctors from exploiting poor, uneducated (and horribly naive) patients?