Review: Rethinking Medications

From Kirkus Reviews

A masterful assessment of a highly flawed health care system.

Unsettling news about prescription drugs.

Avorn, professor of medicine at Harvard Medical School, reminds readers that pharmaceutical companies, despite bitter opposition, were required to prove that their drugs worked beginning only in 1962. Ironically, their first mass support came from radicals when 1980s AIDS activists denounced the neglect and slow pace of anti-AIDS drug approval. Responding, the FDA created an Accelerated Approval program to release drugs quickly based on “surrogate” clinical endpoints. For example: If, early in research, an anti-diabetic drug lowers blood sugar, that’s a hopeful surrogate sign, and it may be approved. But lowering blood sugar does nothing to prevent heart disease, blindness, infections, and other diseases that afflict diabetics. Sensibly, the FDA insists that research proceed, but drug companies avoid this. A drug proven effective does not increase profits because it’s already approved, and failure is disaster.

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