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Goozner on the FDA and the Declaration of Helsinki

Posted by Osagie Obasogie on May 15th, 2008


Over at Gooznews.com, Merrill Goozner describes what may be a significant yet silent step backwards in protecting human research subjects: an FDA decision to no longer adhere to aspects of the Declaration of Helsinki that require clinical trial participants in control groups to receive best available care.

Goozner describes the FDAs new rule as only requiring drug companies to follow good clinical practice, meaning that control group subjects are only entitled to the standard care they would otherwise receive in their locale. Goozner argues that this can have a significant impact on the growing number of clinical trials outsourced to the developing world. He notes:

What will this mean for the concept of "informed consent" in a poor country? Imagine for a moment that you live on $2 a day in, say, Zimbabwe, and have high blood pressure. Since the disease isn't life-threatening, you skip buying the available anti-hypertensives being sold in the village pharmacy because you can't afford them and none are on the national formulary. Hence, there is no local standard of care.

Now say you learn while visiting the village clinic that an international pharmaceutical company is recruiting patients for a clinical trial testing a new anti-hypertensive drug. If you join the trial, you may only get the placebo. But there's a 50-50 chance you will get the new drug, which hasn't been proven yet, but might work.

Are there risks associated with taking this new drug? Well, so far, none that the doctors think are serious enough to cancel the trial. But it says right on the form that something may turn up in the clinical trial in which you are being asked to participate. You sign up. After all, a 50-50 chance of getting a drug that has a good chance of working (the drug industry wouldn't be here testing it if it didn't, right?) is better than no drug at all. And how much risk could there be, anyway?

Is that really non-coerced, informed consent?

[Update: There has still been no coverage of this development in the mainstream media, but Sonia Shah discusses it over at The Nation.com. Shah is the author of The Body Hunters: Testing New Drugs on the World's Poorest Patients.

See also bronxdoc's post at The Social Medicine Portal.]





Posted in Bioethics, Osagie Obasogie's Blog Posts, US Federal


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