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A New Ethical Lapse May Compromise Drug Trials

Just when you'd think the FDA might be getting the hint their practices and ethics seriously need to change comes this brief news item about the agency's desire to circumvent established guidelines regarding international drug trials. Seems the FDA has proposed international guidelines in place to protect patients don't need to apply to drug trials conducted overseas.


The ever-vigilant consumer group Public Citizen and the Federak Universdity of Minas Gerais in Brazil blasted the FDA proposal as another example of the Beltway ignoring the Declaration of Helsinki, global rules hashed out and decided by 82 national medical associations. The bone of contention: The Declaration requires patients who participate in a clinical drug study be allowed to have access to them after trials are over. (It also placed limits on the use of placebos.)

Instead, the FDA wants to weaken such rules, so that patients not be guaranteed access to drugs after the fact. The lone requirement would be that such international trials would have to meet "good medical practice standards." The groups who blasted the FDA proposal call it just one more case of U.S. exceptionalism in which the feds sidestep any responsibility for any possible damage that may happen as a result of their flawed, failed policies.

Could this be just one more way the FDA can sidestep scrutiny for its many flawed practices, perhaps, by muzzling any ongoing feedback about potentially toxic drugs after such trials are over? How many people have to die as a result of "wonder drugs" before the FDA finally gets it?

Yahoo News March 24, 2005

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