Drugs: Those Adverse Effects

Pharmaceutical manufacturers have been accused, and one has been convicted, of suppressing reports of adverse reactions to their drugs. Last week a major drugmaker pleaded to have such bad news made more widely available.

Dr. Daniel L. Shaw Jr., medical director of Wyeth Laboratories, told the Pharmaceutical Manufacturers’ Asso ciation that reports of adverse reactions now go to the Food and Drug Administration, which compiles them in a monthly review. Relayed to press and public, review items often cause alarm. But they consist largely of unevaluated “raw data”; many of the cases, said Dr. Shaw, have not been checked to make sure whether the patient was indeed taking the drug named, or taking other drugs with it. The FDA, which cannot afford to investigate every case, keeps the names of doctors and patients confidential. This information, suggested Dr. Shaw, should be given to manufacturers—who have the means and the motivation to ferret out the facts.