The blind allegiance to what I call the “fool's gold standard” lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances.
The Double Blind Placebo Controlled Trial
The blind allegiance to what I call the "fool's gold standard" lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. Still, sponsors and researches continue to design and conduct such trials, providing the familiar excuse: "The FDA made us do it."
By
Alan MilsteinThis premium content is locked for LawJournalNewsletters subscribers only
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