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June 22, 2010 

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

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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