Keeping Doctors in the Dark
By Lawrence Diller
Wednesday, March 24, 2004; Page A21
The Food and Drug Administration issued an official warning this week on the increased risks of suicidal tendencies when taking antidepressants such as Prozac. The makers of Prozac and of nearly every other major antidepressant used in this country (Paxil, Zoloft, Wellbutrin, Effexor, Celexa, Lexipro) will have to include a new warning on the package label. This action is the culmination of more than 10 years of efforts to bring to light potential dangers of these medications.
The new warning alerts doctors and patients that in the first days and weeks of treatment, side effects such as agitation, panic, irritability, insomnia and severe restlessness may occur, contributing to an overall increase in the risk of suicide. More than a decade ago similar concerns over Prozac were beaten down in U.S. courts by an onslaught of "expert" testimony of industry-sponsored researchers and legal arrangements that gagged victims and their families with large monetary settlements.
In fact, it's likely we still wouldn't have the information on the antidepressants today, if it weren't for foreigners, specifically British doctors, who were more skeptical about the antidepressants' value in treating depression in children. The Medicines and Healthcare products Regulatory Agency, Britain's FDA, first issued a warning on Paxil and Effexor last summer. In October, all the antidepressants known as SSRIs except Prozac were banned because studies from the United States did not show they were effective in treating children with depression, but did show that they were twice as likely as placebos to lead to suicide.
The British decision led to the FDA's move to hold a hearing on Feb. 2 in Washington. Until that time, of seven published studies of SSRI use for childhood depression, only three demonstrated positive effects as compared with placebos. At the meeting, doctors and patients learned that the FDA had eight additional drug company studies in its "back files" that also showed no positive effects for the drugs but were never published. The drug companies had performed these studies under the "pediatric rule," which extended the patents of these medications for the companies by six months. But the companies were under no obligation to publish them, and so they languished in darkness until the British government's action made us aware of them.
At the meeting, even researchers and academic psychiatrists who were well-known proponents of psychiatric medication for children pleaded for transparency in research findings. How can doctors make sensible decisions when most of the studies are withheld from public scrutiny? The companies responded that the studies are proprietary company property and that publication of such data could hurt their product and stockholders.
The lack of an economic interest also precludes any systematic follow-up on drugs once they are approved by the FDA. Most studies required for FDA approval last only a few months. Once approved, these drugs can be used forever, and for whatever purpose a doctor sees fit to prescribe them. The drug companies have little incentive to check whether the medicines are still working years into a treatment. And it can take years of general use before side effects are discovered to be associated with a drug.
It seems that only the trial lawyers have a vested economic interest in following up on medications. That's a costly post-marketing surveillance system, both to the society that absorbs the legal costs and to the people hurt by a medication, before enough publicity or economic pain is felt by the manufacturer to change the label or withdraw the drug. Nearly 80 percent of respondents to a poll on my Web site said they'd pay at least a 1 percent surcharge on their medications to fund independent, systematic follow-up on pharmaceuticals.
The FDA decision to issue its warning on antidepressants is a vindication, albeit a much delayed "bitter pill" to the families that lost a child to suicide as a result of taking what might have been no better than placebo treatment. How many more children must die from other questionable drugs before our government takes the necessary actions to "heal" the sick regulation of the pharmaceutical industry?
The writer practices behavioral-developmental pediatrics in Walnut Creek, Calif., and is the author of "Should I Medicate My Child?"
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