Pass legislation to force disclosure of drug info.(Viewpoint: the consumers union perspective)

Many consumers are still reeling from the recent run of frightening news about the safety of prescription drugs in the U.S.

The parents of children taking the antidepressant Paxil were stunned last year to learn not only that the medication was not effective in children but also that it may increase the risk of suicide in children and teenagers. In September, millions of Americans taking the arthritis-pain drug Vioxx saw it pulled from the market after its link to heart-attack risk was firmly established. A few months later came the news that Celebrex, the most widely prescribed arthritis-pain medication, raised similar concerns.

How can drugs approved by the federal government and heavily advertised sometimes do more harm than good?

The answer lies primarily in gaps in our nation's drug-safety system. Before new drugs are allowed on the market, pharmaceutical companies must test them on individuals for safety and effectiveness, and the information is submitted to the Food and Drug Administration. But after a drug is approved, neither the drug company nor the FDA is required to make details of clinical-trial results public; how the drug was tested, its effectiveness, and information on possible side effects can remain hidden from the public for years.

This can lead to situations such as the one involving Paxil. GlaxoSmithKline, the maker of Paxil, had a study of the drug published in a psychiatry journal, but it referred to the increased suicide risk as mere emotional instability. Two other studies showing that the drug was ineffective were never published. Those three studies circulated at the FDA for close to a year and a half before the agency required that the strongest warning be placed on Paxil.

Reports show that the drugmaker Merck and the FDA were aware of the ...