Inside the FDA: The Business and Politics behind the Drugs We Take and the Food We Eat.

• Author: Conko, Gregory
• Position: Book review

Inside the FDA: The Business and Politics behind the Drugs We Take and the Food We Eat By Fran Hawthorne New York: John Wiley and Sons, 2005. Pp. 338. $27.95 cloth.

In October 1988, one thousand AIDS activists, patients, and supporters marched on the U.S. Food and Drug Administration's (FDA) headquarters in Rockville, Maryland, to protest what they viewed as the agency's apathetic approach to the introduction of new AIDS treatments. As Fran Hawthorne describes the scene in Inside the FDA, some of the marchers carried signs with messages such as "FDA red tape killed me" (p. 54). Many protested that the FDA's indifference arose from the same antigay bigotry they experienced from the rest of society. The real tragedy, however, is that the agency's slow pace in approving drugs was not the result of discrimination. The FDA was treating AIDS patients just as it treats everyone else.

Indeed, by FDA standards, AIDS medicines were getting special, accelerated approvals. A year earlier the agency had cut short the customary three-phase clinical-testing regimen and approved azidothymidine, or AZT, after the drug showed strong results in its Phase II trials. Most drugs go through roughly six or seven years of clinical testing before manufacturers even submit a New Drug Application for the FDA's review. Then, agency reviewers take another year or two on average to comb through the assembled data and make an approval decision.

Drug names such as Thalidomide and Vioxx serve as a constant reminder that approved drugs can sometimes have very harmful effects. So agency drug reviewers know they have to be extra cautious in making approval decisions. Yet, as far too many AIDS patients have found, when that attitude leads to lengthy delays between the time new drugs are found to be "safe" and when they are approved for sale, overcaution can be deadly.

Few books for a general audience describe as clearly as Inside the FDA does the competing tensions that govern the FDA's operations. The agency can make what statisticians call Type I errors, approving drugs that later turn out to have harmful side effects that outweigh any therapeutic benefit. Or it can make Type II errors, denying approval for drugs whose benefits would swamp any risks. No drugs are totally safe. So the FDA's mission is to chart a course that balances the risk of moving forward too quickly with the risk of staying too long in the past. Both approaches have serious health consequences. Both can...