Outsourcing Drug Trials

Companies Facing Ethical Issue as Drugs Are Tested Overseas

I found this really disturbing. I was even more disturbed that the article didn’t reflect my biggest concern — that the lack of regulation in other countries that makes recruiting and testing drugs may lead to something really bad happening in the future of American medicine. The reporter tries to assuage me:

“The standards of medicine are high” in those countries, said Dr. Alan Wood, Covance’s general manager for global clinical development services, and it is easy to recruit patients.

But I am not so easily convinced. After all, a big reason why we’d rather go overseas for human guinea pigs is because the paperwork is too expensive. And American doctors are paid too well. (Hmph well maybe we should send these studies to Cuban doctors.) But what happens when the paper trail isn’t as good? What happens when really bad shit happens? Do you really want to test drugs in a situation where you get so many subjects, but only because they can’t afford to see a doctor? Is there an incentive to pretend you have this or that condition so that you can receive the basic checkup that is associated with many medical studies? Will this skew the testing results? The FDA must have this all taken care of right? So that when you come before them you have to prove that even though you did your study in some other country because it’s cheaper, the test was still good, right?

Somehow I feel like I’m reiterating Dan’s post about the dangers of inviting another Therac-25.


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