In a move geared to permit exploitation of the world’s most destitute people, the FDA has apparently decided to permit drug companies to conduct human subjects research overseas in ways that are barred under pertinent domestic ethical rules and guidelines. From the story :
[T]rials performed outside the United States will no longer have to conform to the Helsinki Declaration even though they will be used to support licensing of drugs in the United States. Instead they will be regulated by the Good Clinical Practice guidelines: not an aspirational ethical code but a manual describing existing procedure for industry sponsored trials. This double standard could give the impression that the FDA “is more interested in facilitating research than respecting the rights of people who are subjects of research”.
This is rank biological colonialism. Permitting human research ethical rules to be outsourced (the term “outsourcing of ethics” was coined, I believe, by my friend William Hurlbut), says, in essence, that people in foreign countries have less value than Americans, and hence, that our corporations can use them in instrumental ways that would never be countenanced among our own people.
The FDA excuses this rule on the basis that it has no jurisdictional control overseas. That may be true, but it can—and should—refuse to consider approving any product or drug that has not been tested under USA ethical standards for the treatment of human subjects—and animal care for that matter. Pressure needs to be brought to bear to reverse this unethical ethical ruling by the FDA.
