National Office Of Drug Safety Is Needed, Experts Say In JAMA

WINSTON-SALEM, NC -- Three leading advocates of safer pharmaceuticals have called for a national office of drug safety to monitor the adverse effects of prescription drugs, which they say could be the fourth-leading cause of death in the United States.

"Overall, 52 percent of approved drugs have serious adverse effects not detected prior to approval" by the U.S. Food and Drug Administration (FDA), says a commentary in this week's Journal of the American Medical Association by Curt D. Furberg, M.D., Ph.D., of Wake Forest University Baptist Medical Center, Thomas J. Moore of George Washington University Medical Center, and Bruce M. Psaty, M.D., Ph.D., of the University of Washington.

They say in the commentary that the FDA's focus is on approving new drugs and not on monitoring drugs after they have already entered the marketplace. "Merely recording adverse effects is not by itself sufficient to protect the public.

"Each year, prescription drugs injure approximately 1.5 million people so severely they require hospitalization, and 100,000 die." One major job of the new national office, the authors say, should be first to develop "reliable estimates of deaths and serious injuries from prescription drugs," and second to implement procedures to reduce the number of drug-related injuries.

"Without [good] data, it is impossible to tell whether serious injuries associated with prescription drug adverse effects are declining or whether an epidemic of drug-induced injury may be occurring," they write.

They observe that the FDA has 1,400 employees working on approving new drugs, but only 52 monitor the safety of 5,000 drugs already in the pharmacies or available over the counter. They noted that the agency's Division of Pharmacovigilance and Epidemiology has only seven physicians and one epidemiologist. In a reorganization expected later this year, the office will become the Office of Post-Marketing Drug Risk As

Contact: Robert Conn
Wake Forest University Baptist Medical Center

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