Banning a drug carrying some risk is not always best prescription

"This is a very confusing situation," a top Food and Drug Administration scientist, Sandra Kweder, said of the controversy over Celebrex and other popular pain relievers. If the FDA is confused, imagine the feelings of doctors and patients caught in the backlash.

The story so far: Celebrex, along with Vioxx and Bextra, were a new class of drugs that held great promise to relieve suffering from arthritis without causing the digestive discomfort and bleeding associated with older medications. They were heavily marketed, and sales reached billions of dollars.

Three months ago, a study confirmed fears that Vioxx increased the risk of heart attack and stroke. Now Vioxx is off the market, pulled by its manufacturer, and last Thursday the FDA urged doctors to limit prescriptions for Celebrex and Bextra.

The Vioxx debacle exposed a much larger danger: The FDA's monitoring of new drugs is inept. Even after Vioxx was implicated in up to 40,000 deaths, the agency seemed to react only after one of its scientists, David Graham, turned whistleblower and told Congress that the FDA's procedures guarantee that unsafe drugs remain on the market.

As we've noted previously, that problem needs to be addressed urgently. Drugs that show Vioxx-like dangers should be removed, or their use should be sharply restricted. But another danger is emerging: the risk that overreaction will make helpful drugs unavailable to seriously ill patients for whom significant risk is acceptable.

The consumer group Public Citizen, for instance, is urging that 181 drugs be taken off the market. Doing so, no doubt, would save some lives. It also would relegate many others to pain, disability and premature death.

Nearly half of Americans take at least one prescription drug, and rarely are the safety issues clear-cut.

Consider Celebrex. A study released earlier this month found that patients who received several times the typical dose had an increased risk of heart attack and stroke. Previous studies showed the opposite. Another new study found that Celebrex caused fewer heart problems than naproxen (sold over the counter as Aleve).

If Celebrex were pulled from the market, millions who've found relief from painful, disabling arthritis would have to switch to other medicines such as ibuprofen or naproxen. But those drugs cause severe gastrointestinal problems in some people, resulting in more than 16,000 deaths a year. Patients and doctors have to decide whether the potential cardiac risk outweighs the drug's benefit.

Certainty about drugs is impossible because clinical trials before FDA approval involve only a few thousand patients. New risks, or benefits, can emerge once the drug is prescribed to millions. , for example, was showing promise for preventing precancerous colon polyps.