A disclosure dilemma: what you don't know can kill you, but so can what you do know.
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.
University of Minnesota Law School, USA.
Lisa M
LM
von Biela
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects; D030881:Disclosure / Q000941:ethics / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000941:ethics; D006801:Humans; D007258:Informed Consent; D007880:Legislation, Drug; D022123:Lyme Disease Vaccines / Q000009:adverse effects; D012307:Risk Factors; D013405:Suicide; D014481:United States; D014486:United States Food and Drug Administration / Q000941:ethics / Q000331:legislation & jurisprudence
D000928:Antidepressive Agents; D022123:Lyme Disease Vaccines