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In 2004, the FDA urged drug companies to adopt a 'Don't…

“In 2004, the FDA urged drug companies to adopt a 'Don't ask, don't tell' policy with respect to their clinical-trial data showing that antidepressants are not better than placebos for depressed children. If the data were made public, they cautioned, it might lead doctors to not prescribe…” quote by Irving Kirsch
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““In 2004, the FDA urged drug companies to adopt a 'Don't ask, don't tell' policy with respect to their clinical-trial data showing that antidepressants are not better than placebos for depressed children. If the data were made public, they cautioned, it might lead doctors to not prescribe antidepressants. The FDA believed that the jury was still out on antidepressants for children. Even if the clinical trials show negative results, an FDA spokesperson was reported to have said to a Washington Post reporter, it doesn't mean that the drugs are ineffective. The assumption seems to have been that doctors should prescribe medications that have not been shown to work, until it has been proven that they don't work.””

Irving Kirsch

About This Quote

This interpretation was drafted with AI assistance. It is one reading of the quote, not the author's own explanation.

The FDA discouraged releasing negative trial data to avoid discouraging prescriptions, prioritizing market stability over transparency.

In simple terms: FDA kept data hidden to keep drugs prescribed.

Key Takeaway

Balance transparency with public health concerns.

Themes

ethics medical research regulation

Mood

cautious critical

Type

ethical analytical

When to use this quote

  • clinical trials
  • policy making
  • patient counseling

Key Concepts

data transparency patient safety pharmaceutical industry

Questions to Reflect On

  • Should patients be fully informed of drug efficacy?
  • How to weigh risk of withholding data?
A Different Perspective

Revealing data could cause panic or reduced treatment.

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