Guatemala revelations reopen worries about the oversight of overseas medical trials
Tuesday, October 5th, 2010
University of Pennsylvania bioethicist Art Caplan says news about secret medical tests from 60 years ago could have a chilling effect on overseas clinical trials today.
Federal officials apologized last week when the news broke that U.S. medical teams from the 1940s infected Guatemalan prisoners and mental patients with sexually transmitted disease in order to test the effectiveness of penicillin.
The United States now has a system of protections and informed consent, but Caplan says it is not clear that those protections follow international studies when they are shipped overseas.
Caplan: When we ask the local committee in some Indian province to approve it, are they up to the job? Can the local subjects really understand in any serious way what we are telling them about research? Or are they just so thrilled to see someone appear in a white coat offering medicine that they sign up no matter what?
Caplan says drug companies often choose to test their medicines outside the U.S. because the costs are lower and it can be easier to recruit trial participants.
In a statement, Secretary of State Hillary Clinton and the U.S. Health Secretary said safeguards now exist to prevent mistreatment of those who join a medical trial. But Caplan says the globalization of clinical trials needs more U.S. oversight.
Caplan: It's one thing to get assured by the local government that things are fine. It's one thing to be assured by a pharmaceutical company, with respect to research in a poor country but having independent assessment, taking a look, I just think that's crucial.