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A disclosure dilemma: what you don’t know can kill you, but so can what you do know.

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Abstract

No medical intervention comes without risks. Certain risks may be grave, but will only occur in a fractional percentage of cases. When does the disclosure of risks of this nature create more harm than good, leading patients to avoid therapies that, on balance, would provide significantly more benefit than risk? This article explores several high-profile disclosures of high severity/low probability risks in devices, drugs, and biologics that resulted in harmful unintended consequences. It contrasts the conflicting interests of manufacturers, the Food and Drug Administration (FDA), medical professionals and patients/consumers. It critiques several proposed approaches to the issue, then presents its own disclosure framework.

Food Drug Law J. 2010;65(2):317-46, ii.

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