The Food and Drug Administration has one overarching mandate from Congress: Make sure that all drugs are safe and effective.
Sounds simple, but it’s far trickier than it seems. For one thing, there is no such thing as a drug that is effective for everyone. For another, all medicines have side effects and therefore are unsafe for some people.
The real issue, however, is how FDA finds out about such side effects and alerts doctors to them. Some complications show up in clinical trials, and those get listed in the approved prescribing information. But clinical trials only include a few thousand subjects at most. Often, the studies are short, lasting a few weeks or months. As a result, serious side effects may only be discovered years after a medicine has been marketed.
One need look no further than Vioxx for arthritis, Avandia for diabetes or HRT for preventing heart disease in women to find examples of serious problems that became apparent much later.
Part of the problem is that doctors frequently don’t recognize drug-induced symptoms. A study in the medical journal Drug Safety (August 2007) showed that doctors frequently dismissed patients’ complaints of muscle problems, memory impairment or nerve pain as unrelated to the statin-type cholesterol-lowering drugs they were taking. It is disappointing that some doctors blew off side effects that have been well reported in the medical literature. The authors conclude that if doctors don’t recognize these issues as side effects, they are not likely to report them to FDA. They suggest that side-effect reports from patients would be a valuable addition to the system.
But will FDA pay attention? The agency collects information about drug complications through MedWatch. Doctors are encouraged to submit reports about serious side effects to MedWatch, but that happens infrequently. Patients are permitted to do so as well, but there is a perception at the agency that patient reports are less reliable.
In truth, MedWatch is understaffed and has difficulty responding to side effect reports regardless of where they come from. What the FDA does with those that are submitted remains mysterious. Sometimes it seems that the agency is far more dedicated to downplaying drug dangers than to warning physicians and patients about them.
