Keeping Science on Top in Drug Evaluation (NewEngJourMed)

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http://content.nejm.org/cgi/content/full/357/7/633?query=TOC

Keeping Science on Top in Drug Evaluation
Jerry Avorn, M.D.

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 Science may also be defeated at later stages of the policymaking process, as when the FDA commissioner overruled the nearly unanimous recommendations of both internal and external scientists about the safety of emergency contraception (the morning-after pill). Unfortunately, the upcoming reauthorization of user-fee funding at the agency will lock in 5 more years of dependence on support from pharmaceutical manufacturers to pay the salaries of the FDA's internal drug-review staff, renewing concern about the relationships between science, commerce, and federal policy and making the independence of external advisers even more critical.2

But though the quiet voice of science may often be no match for powerful vested interests or ideology, some encouraging signs may be in the air. The same reauthorization bill, disappointing in so many respects, may tighten somewhat the conflict-of-interest rules for outside advisers. In addition, some recent committee decisions provide interesting contrasts with recommendations made several years ago about similar drugs

Source Information

Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital — both in Boston.

http://content.nejm.org/cgi/content/full/357/7/633?query=TOC

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