FDA credibility is at stake

Providence Journal: A federal advisory panel has not settled the question of whether antidepressants endanger youngsters. But its solid 15-to-8 recommendation this month that such drugs should carry the strongest possible warning ought to be heeded by the federal Food and Drug Administration.
The controversy took on urgency last year when the British government warned doctors against prescribing six drugs out of fear that they could make some young people suicidal. (One antidepressant, Prozac, was exempted.)
Since then, hearings in the United States have featured often heart-rending testimony by parents whose children took their lives, and who believe that medication was the cause. Some parents and youngsters have taken the opposite side, pleading that antidepressants helped.
The stakes in this debate are high. After homicide and accidents, suicide is the third-leading cause of death among teenagers. The FDA now concedes there is some link between antidepressant use and youngsters' becoming suicidal. But the risk appears relatively small: For every 100 patients, two or three are likely to be affected.
Perhaps more stunning, the FDA advisory panel found little evidence (Prozac excepted) that the drugs had helped. Without doubt, parents and physicians should know all this. Although the data remain problematic, the FDA's "black-box" warning -- its strongest -- is for now appropriate.
The problem laid bare by this controversy is that prescription drugs are developed with too little government supervision. The FDA relies on trials conducted by the manufacturers in deciding whether to approve a pharmaceutical. These studies can be cursory; negative data can be buried.
It did not help build public confidence that the FDA last year suppressed a finding by its own drug-safety analyst, Dr. Andrew Mosholder, linking antidepressants with suicidal tendencies among the young. His conclusion was later confirmed by Columbia University researchers.
Parents mourning the loss of their children are unlikely to feel that the FDA protected them in this case. They are also unlikely to believe that the drug companies told all. (It is now clear that some negative data on young people and antidepressants was never reported.)
To regain credibility, the FDA must impose better standards for clinical trials and trim the pharmaceutical industry's control over testing. All evidence from clinical trials, good and bad, should be disclosed.
Unfortunately, the Bush administration is moving in the opposite direction: It proposes prohibiting legal action against makers of any FDA-approved drugs. Regrettably, the lack of a transparent system makes it vital that the legal system remain one means of getting at hidden information.