For Immediate Release

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Foreign Clinical Trials for U.S. Drugs Present Significant Threat to Test Subjects, Integrity of Data

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

WASHINGTON - The U.S. Department of Health and Human Services (HHS) Inspector
General report challenging the Food and Drug Administration's (FDA)
ability to monitor and inspect foreign clinical trials confirms some of
the worst fears about the serious dangers of the escalating
globalization of human experimentation. In addition to the increased
dangers to human subjects in many countries because they have less
adequate protections than in the United States, there are significant
threats to the integrity of the data being generated from these
experiments because of the decreased ability of FDA to monitor and
inspect foreign sites, occurring only 37 percent as frequently as
inspection of domestic clinical trial sites. In addition, the Inspector
General found that the "FDA was 16 times more likely to inspect a
clinical investigator at a domestic site than a foreign site."

As a result, the quality of the data used by the FDA as a basis for
approving the drugs being studied may well be flawed, resulting in
dangerous, incorrect decisions to approve drugs, jeopardizing the health
of people in this country and elsewhere. Massive marketed use of drugs
that possibly should not have been approved extends the dangers beyond
the subjects of the clinical trials to the general public.



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