Science News Update May 20, 1998
American Medical Assocation Navigation

Science News Update

Week of May 20, 1998

American Medical Association Science News Updates are made available to the public after 3 p.m. Central time (U.S.) on the first four Tuesdays of each month. We keep some back issues on this issue and have a list of available releases.



  • U.S. Drug Safety Monitoring Must Be Expanded


Commentary calls for pharmaceutical companies to provide
ing for enhanced safety program

CHICAGO—The nation needs an office of drug safety with the authority, independence, funding, and legal mandate to undertake all the responsibilities of drug safety monitoring, according to a commentary in the May 20 issue of The Journal of the American Medical Association (JAMA).

Thomas J. Moore of the Center for Health Policy Research at George Washington University Medical Center in Washington, D.C., and colleagues, note that an estimated 1.5 million people require hospitalization and 100,000 die each year because of injuries linked to prescription drugs. Overall, 51 percent of approved drugs have serious adverse effects which are not detected prior to approval. They point out that the diet drug fenfluramine was approved 24 years before studies on heart valve damage prompted the Food and Drug Administration (FDA) to pull it from the market.

The authors write that an effective program to protect the American public from the health risks of marketed drugs should address four specific tasks:

Estimating the number and cause of serious injuries and deaths. Without this information, it is impossible to determine if serious injuries associated with adverse effects of prescription drugs are declining, or if an epidemic of drug-induced injury may be taking place. The authors write: "It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a National Highway Transportation Safety Administration operating without information about automobile accidents, or a Federal Aviation Administration not knowing how many airplane crashes have occurred."

Identifying new serious reactions. The FDA's Division of Pharmacovigilance and Epidemiology (DPE) devotes most of its staff and resources to this task. Reports of adverse reactions to recently marketed drugs are collected from consumers, physicians, pharmacists, nurses, and other health professionals. But the authors point out that the FDA estimates only about one percent of adverse events are ever reported. And they add: "A spontaneous reporting system also cannot capture adverse effects that manifest themselves as a disease with high prevalence or with a long delay between exposure and clinical manifestations. Cancer is the classic example."

Monitoring the effect of previous safety alerts. The FDA has no organized program to check whether important warning messages about product labeling about drug use are being heeded. But the limited information available suggests that some warnings are not received, or have little effect. The authors write: "It is important to discover why important safety warnings are not being heeded. Are 'Dear Doctor' letters and label changes being lost in the avalanche of pharmaceutical marketing and advertising information being sent to the physician's office? Or do physicians disbelieve the message?"

Operating an early-warning system. Rather than waiting passively for spontaneous reports of adverse reactions, the authors say active surveillance is needed to check for sensitive indicators of possible problems: "In particular, regular monitoring is needed to check for drug involvement in reported cases of birth defects, agranulocytosis, a disorder primarily caused by drugs, and aplastic anemia, which is frequently caused by drugs. So many drugs--including tricyclic antidepressants, agents for migraine headaches, diet drugs, class I antiarrhythmics, non-sedating antihistamines, and cardiac glycosides--have been linked to arrhythmia and other cardiac effects that a cardiac early-warning system may also be warranted."

The authors propose that funding for an expanded drug safety program should come from user fees collected from pharmaceutical companies: "The drug industry should be no less liable for the costs of its safety regulation than the nuclear power industry, which pays for the full costs of the Nuclear Regulatory Commission. Even if the pharmaceutical industry, already the nation's most profitable as measured by return on investment, passes on the whole burden to consumers, the added cost would be small. Just one penny per prescription would yield approximately $24 million for an enhanced drug safety monitoring program."

They conclude: "This investment in drug safety has the potential to save thousands of lives and prevent tens of thousands of serious injuries every year."
(JAMA. 1998; 279:1571-1573)