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Arch Gen Psychiatry. 2000;57:321-322.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

NEW MEDICINES for which a manufacturer seeks market approval are usually tested against placebo, irrespective of whether effective treatment already exists for the condition. This is a requirement set forth by the US Food and Drug Administration (FDA).¹ The FDA maintains that placebo-controlled trials are necessary for an easy comparison of the new drug with "nothing," whereas evaluating therapeutic equivalence of a new vs an old medication is more problematic.² Many patients in clinical trials are therefore deprived of effective medications. A few years ago, my colleague Ken Rothman and I drew attention to this unethical use of placebo controls.³ If effective therapy exists, the physician has an ethical and legal obligation to provide it to the patient according to ethical standards that are laid out in the Declaration of Helsinki.⁴ The Declaration of Helsinki mandates that a new drug be compared with the best available treatment, thus placing the . . . [Full Text of this Article]

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