Healthy Skepticism Library item: 11221

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Avorn J.
Keeping Science on Top in Drug Evaluation
NEJM 2007 Aug 16; 357:(7):633-635
http://content.nejm.org/cgi/content/full/357/7/633

Abstract:

In many sectors of American life – energy, defense, finance, pharmaceuticals – the government stands poised between powerful industry groups and the needs of the citizenry. But in only one of these areas, prescription medications, is there a formal public mechanism for integrating science into the national decision-making process. At their best, U.S. drug-approval procedures include an open system in which outside scientists come together as advisory committees to the Food and Drug Administration (FDA), publicly evaluate the available evidence, and render opinions to guide the agency’s decisions. The approach is based on the insight that a deep reservoir of knowledge and judgment exists in the academic and clinical communities about often arcane matters of drug benefits and risks – a kind of expertise that would be impossible to equal inside any government agency. In theory, the FDA’s advisory committee system aspires to the Platonic ideal of a group of disinterested experts giving freely of their wisdom to guide the republic’s decision making.

Of course, the system doesn’t always perform as well as it should. In recent years, the FDA has been less stringent about allowing the participation of committee members who have commercial conflicts of interest, despite evidence that such ties help shape opinions.1 …

Notes:

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