Off-label promotion, on-target sales
2008
Off-Label Drug Promotion and Patient Safety
publication
Evidence: moderate
Author Information
Author(s): Adriane Fugh-Berman, Douglas Melnick
Primary Institution: Georgetown University Medical Center
Hypothesis
Pharmaceutical companies covertly promote off-label drug use even where such promotion is illegal.
Conclusion
Off-label drug use can pose significant risks to patients due to the lack of regulatory oversight and scientific support.
Supporting Evidence
- Three-quarters of marketed prescription drugs have no labeling indications for children.
- Misoprostol is widely used off-label for various obstetric indications despite being approved only for preventing ulcers.
- 21% of all prescriptions written in the US are off-label, with many lacking scientific support.
Takeaway
Sometimes doctors use medicines for things they weren't officially approved for, which can be risky because those uses haven't been tested properly.
Potential Biases
The authors have personal experience in the pharmaceutical industry, which may influence their perspective.
Limitations
The paper does not provide empirical data or specific studies to support its claims.
Digital Object Identifier (DOI)
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