Editorial: Be wary if taking new pills

Friday, May 3, 2002 | 10:15 a.m.

American patients, who together are spending $100 billion a year on prescription drugs, would do well to read this month's edition of The Journal of the American Medical Association. Six doctors collaborated on a report that advises consumers to be wary of any relatively new drug. Despite its stamp of approval from the Food and Drug Administration, there is a 20 percent chance that as more becomes known about a drug, based on the outcomes of people to whom it has been prescribed, it will either be withdrawn or marketed with warnings about serious side-effects, the study concludes.

The Food and Drug Administration doubts the 20 percent figure, but nevertheless acknowledges that, "Clearly, physicians and patients should be aware that recently marketed drugs are at risk of being found to cause unsuspected serious adverse effects." The Journal study found that pharmaceutical companies "frequently market new drugs heavily to both patients and clinicians before the full range of ADRs (adverse drug reactions) is ascertained." They report, for example, that nearly 20 million patients in the United States took at least one of the five drugs withdrawn from the market between September 1997 and September 1998.

With the intense public pressure on the FDA to approve promising new medicines in a timely manner, we would not expect the agency to suddenly revamp its approval procedures for potentially lifesaving drugs. The FDA and the drug industry would, however, be doing a public service by subjecting other drugs to more extensive tests. Patients, meanwhile, might want to read up on the subject. We say that because this study comes at a time when the ethics of many pharmaceutical companies are under investigation by federal agencies and Congress. Many ads for drugs implore consumers to "ask your doctor." But reports are emanating from news outlets and medical industry trade publications that many drug companies provide gifts and pricing incentives to doctors with the goal of seeing more prescriptions written for their brand.

The trust that patients place in their doctors and the FDA is mostly well placed. But when it's your health -- even your life -- that's at stake, a little personal knowledge might help when it comes time to swallow that pill.