Stronger Child-Suicide Warning Advised
Antidepressants May Put Some Kids at Risk, FDA Panel Says
Suicide and Antidepressants: No Clear Answers continued...
"We at the FDA, however, do not view negative studies as proof of no benefit," he writes. "Nevertheless, the failure of most of these programs to show a benefit in major depressive disorder does heighten the concern about the possibility of certain risks that may be associated with these drugs."
To find out more about these risks, Laughren's team asked the drug companies to comb through their data for any sign that antidepressants increased suicidal thoughts or behaviors. The results were disappointing. The different companies interpreted the FDA request in different ways, making the resulting information difficult to interpret.
Given the same data, however, British authorities were quick to act. The U.K. Medicines and Healthcare Products Regulatory Agency strongly advised doctors not to use the drugs in children and teens. Further, they insisted that the drugs' labels carry this warning. As of Dec. 10, 2003, the U.K. effectively bans Paxil, Effexor, Zoloft, Celexa, and Lexapro for children and teens. Only Prozac is seen to have a favorable risk-benefit profile.
Patient Advocates on Both Sides
Patient advocates are arguing both for and against antidepressants for children. The National Mental Health Association is strongly urging the FDA to approve the drugs. The Center for Science in the Public Interest is demanding that the FDA remove three panel members because of financial support from the pharmaceutical industry. And the Alliance for Human Research Protection says the FDA has "stacked the deck" by denying independent scientists sufficient opportunity to present crucial research findings.
The FDA's Laughren offers the panel a way out. He's asked a Columbia University group to act as an independent consultant to review the drug company data. This solution may get the FDA panel off the hook -- but it won't make everybody happy.
At the heart of the problem is the nature of depression and its treatment. Depression can be deadly. Suicide is much more common in depressed people than in others.
Clinical trials don't conclusively show that antidepressant drugs work. That's because the studies compare the drug to inactive placebo. And depressed patients who enroll in clinical trials, have interactions with medical staff, and receive realistic-looking sugar pills tend to get better. This so-called "placebo effect" can be a nightmare for drug trials.