Thursday, June 28, 2007

It is time to bring the power of computers to drug safety

Read the Editorial titled "Fixing the Drug Laws" by Donald Kennedy in Science magazine, 22 June 2007.

Donald Kennedy, who really ought to know says we need to increase funding for the U.S. Federal Drug Administration, change "user fees", improve the situation with antibiotics which are too often becoming ineffective ("deaths from the 1918 influenza epidemic were largely from untreated infections--a chilling prospect as we await possible repetition of such an epidemic"). He also focuses on monitoring adverse drug reactions, calling for publication on the Internet of data provided to FDA in the approval process, and stating
that the United States lacks a system that is adequately tuned to detect adverse reactions. That measure requires a numerator and a denominator: the number of reported adverse events divided by the number of prescriptions issued. The FDA knows neither. Event reporting is voluntary, yielding a record of dubious reliability, and there's no national prescription record. That's why the FDA had to use Kaiser, a large health maintenance organization, to find an adequate database for evaluating the safety of Vioxx.
Comment: It is now time to have a national registry of what drugs are being prescribed and what people are having reactions that might be adverse reactions to prescribed drugs. Computers are up to the job, and statisticians soon will be up to the job of analyzing such data. JAD

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