RETHINKING MEDICATIONS

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. As a result, most drugs approved today haven’t been shown to benefit patients, and an unnerving number, many wildly expensive, are considered useless by experts, if not by their manufacturers. Others are toxic, but, Avorn writes, “for decades the FDA had a kind of attention deficit disorder concerning drugs it has already approved.” Vioxx, an anti-inflammatory similar to Motrin or Advil, became the world’s bestseller after its 1999 approval. It also greatly increased the risk of heart attacks and strokes, although five years passed before it was pulled from the market. Similar debacles abound, so readers may breathe a sigh of relief at the author’s diversions into his life and career at Harvard Medical School, where, he writes, “one eminent department chair…had a standard response to faculty recruits who balked at the paltry academic salaries he was offering them: ‘Just think of it as a base. You can earn much more, maybe double that amount, by consulting for drug companies.’” Avorn provides sensible solutions, but many involve increased government oversight, which seems unlikely these days.

A masterful assessment of a highly flawed health care system.