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Should the Food and Drug Administration Limit Placebo-Controlled Trials?
Published 2022-07-01“…Clause 33 says the effectiveness of a new intervention must be tested against those of the best current proven intervention (s), except in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.[4] The FDA has largely ignored this and deemed placebo controls the gold standard, stating that “PCTs are necessary to control for placebo effect of investigational medicinal product.”[5] The FDA has even refused to approve drugs that are tested against established treatments instead of against placebos, notably atenolol.[6] By stretching the “methodological” exception and failing to define harm reasonably, the FDA does not meet the spirit behind Helsinki’s conditions for allowing PCTs. …”
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