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August 22, 1990

Ethical Implications of Rejecting Patients for Clinical Trials-Reply

Author Affiliations

Harvard School of Public Health Boston, Mass

Harvard School of Public Health Boston, Mass

JAMA. 1990;264(8):974. doi:10.1001/jama.1990.03450080059029

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In Reply.—  I hope and believe that the woolly-mindedness of which Dr Bone accuses me applies to my inability to communicate an idea rather than to any corruption of the scientific process, which would be just the opposite of what I am trying to accomplish. Let me try again to make myself clear.The main point of my editorial was to emphasize the apparent existence of an ethical double standard, illustrated by the actions of the authors of the article in question and by the Food and Drug Administration. If it was considered unethical randomly to assign patients to a control group because of a prior belief about the efficacy of the proposed therapy, why was it not equally unethical to exclude available patients from an uncontrolled trial because their inclusion might make it more difficult to demonstrate efficacy?I carried that idea further by admitting that the same principle