Bush Scandals List

352. FDA loosens rules for drug trials in Third World countries

The Food and Drug Administration (FDA) is set to finalize a rule on October 27, 2008 which, at the behest of drug companies, would drop US adherence to the Declaration of Helsinki. The Declaration outlines how drug trials should be conducted internationally. Increasingly these trials are being conducted in Third World countries. The Declaration requires informed consent be given by study participants, that there be an independent review board, that the well being of participants be monitored, that they be assured of treatment in accord with the best practices identified in the trials, and that the countries from which participants are drawn have some likelihood of benefiting from the results of the trial. Instead the FDA advises only that good clinical practices be used and monitored by a local review board. Such boards in poor countries have been notoriously easy to manipulate and pressure by wealthy drug companies. Most egregiously, the new FDA rules would permit participants to receive placebos in place of the current best treatment. In other words, instead of comparing a new drug against the current best medication, the FDA is sanctioning studies where something will be compared against nothing. This is reminiscent of the infamous Tuskegee syphilis experiment where a cohort of African American males was purposely left untreated although they could and should have been.

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