Winter 2000 Update

Independent drug evaluation

Innovation in public policy requires patience. Five years have passed since Raymond L. Woosley, chairman of the Department of Pharmacology at Georgetown University, made the case for the need for independent evaluation of pharmaceuticals (“A Prescription for Better Prescriptions,” Issues, Spring 1994). On December 10, 1999, the Wall Street Journal reported that Woosley’s recommendations were finally becoming policy.

Woosley’s article expressed concern that the primary source of information about the effectiveness of pharmaceuticals comes from research funded by the pharmaceutical companies. He observed that the companies have no incentive to support research that might undermine sales of their products and no incentive to publish research that does not benefit their bottom line. Further, he noted that the $11 billion that the drug companies were spending annually on marketing their products was more than the $10 billion they spent on drug development. Woosley worried that for too many physicians the primary sources of information about pharmaceuticals were advertising and the sales pitches of company representatives. He reports on research that indicates that physicians often do not prescribe the best drug or the correct dosage. Yet the Food and Drug Administration (FDA) has little power to influence drug selection once a product has been approved. Woosley recounted several unsuccessful efforts to discourage the use of drugs found to have undesirable side effects.

Seeing a need for independent pharmaceutical research as well as objective and balanced information about drugs on the market, Woosley recommended the creation of 15 federally funded regional centers for education and research in therapeutics (CERTS) with a combined annual budget of $75 million. The CERTS would conduct research on the relative effectiveness of therapies, study the mechanisms by which drugs produce their effects, develop new methods to test generic drugs, evaluate new clinical applications for generic drugs, determine dosage and safety guidelines for special populations such as children and the elderly, and assess the cost effectiveness of various drugs within specific populations. In addition, the CERTS would play a role in educating physicians and in monitoring drug safety.

The article generated little action at first (except for some strong criticism from the pharmaceutical industry in the Forum section of the next Issues), but Woosley’s continuing efforts eventually earned the support of Sen. Bill Frist (R-Tenn), and in 1997 Congress passed legislation to create CERTS. The initial plan, funded at $2.5 million, is much smaller than what Woosley thinks is needed, but it’s a beginning. Under the direction of the Agency for Healthcare Research and Quality, CERTS have been established at Duke University, the University of North Carolina at Chapel Hill, Vanderbilt University, and Georgetown University. In addition, the National Institutes of Health (NIH) has begun its own effort to study drug effectiveness, including a five-year $42.1 million effort to evaluative the effectiveness of some new antipsychotic drugs.

Although Woosley is pleased to see that his proposal has finally generated some action, he is disappointed with the level of funding. Noting that independent authorities such as the General Accounting Office, the Journal of the American Medical Association, and the Institute of Medicine have supported his view that research could significantly improve the effectiveness of pharmaceutical use, he believes that the case for much more funding is strong. Yet, Congress turned down an FDA request for $15 million to support this work. He recommends collaborative efforts that would also involve NIH and the Centers for Disease Control. He sees value in the NIH initiative on antipsychotic drugs, but explains that its goal is limited to comparison of the effectiveness of various chemicals. The CERTS goal is to go beyond comparisons to improving drug use, an achievement that would benefit patients, physicians, and the pharmaceutical industry.