Will British Ban Spur FDA to Act? Critics remain skeptical of the FDA's announced plans to take a serious look at possible links between use of antidepressants by children and violent or suicidal acts

0 Comments | Insight on the News, Feb 16, 2004

Byline: Kelly Patricia O'Meara, INSIGHT

For several years a TV commercial has been running in the United States in which a small black circle with a sad face slowly, almost desperately, flops across a stark white screen while a narrator soothingly explains that depression doesn't have to be a part of everyday life. But with help from the antidepressant drug being advertised the sad face becomes a smile, happily floating across the screen to indicate how beautiful life can be with the aid of the mind-altering drug.

Microscopic writing at the bottom of the TV screen advises that depression "may be due to a chemical imbalance," a kind of assurance that the alleged mental disorder for which the drug is recommended is a product of a measurable physical malady confirmed by scientific evidence. Although "may" is the operative word, a "chemical imbalance" sounds scientific. Never mind, experts say, that there is nothing in the medical literature to establish what qualifies as a healthy "chemical balance," let alone what does not.

Critics of the use of mind-altering drugs for alleged mental disorders contend that it is precisely this kind of misinformation that has led tens of millions of people to rush to these new "feel-good" drugs which, in fact, have turned the mood in some of those taking them from down to deadly.

That may be why a recent decision by the British Committee on Safety of Medicines (CSM) may tilt the balance in the debate whether antidepressants hurt more than they help. The CSM is an arm of the Medicines and Healthcare Products Regulatory Agency, the United Kingdom's equivalent of the U.S. Food and Drug Administration (FDA).

The information the CSM provided is so damning that manufacturers of many of the most-widely prescribed antidepressants may find it necessary to add a disclaimer to their feel-good commercials saying that the drugs may cause violence and suicide in children younger than 18. And it is precisely this finding that led the United Kingdom effectively to ban or "contraindicate" the use of most antidepressants by children youn-ger than 18.

Last year, after concerns were raised about patients becoming suicidal while taking antidepressants, the CSM conducted a review of all available evidence provided by the respective pharmaceutical companies about their selective serotonin reuptake inhibitors (SSRIs). The CSM found the "risks of treating depressive illness in under 18s with certain SSRIs outweigh the benefits of treatment." The risk outweighs the benefit.

Of the seven antidepressants under review Zoloft, Celexa, Lexapro, Luvox, Paxil, Effexor and Prozac four (Zoloft, Celexa, Paxil and Effexor) were found to increase the rate of self-harm; two (Lexapro and Luvox) had no clinical trial data available in which to make a decision. Only Prozac, the mother of psychopharmacological intervention, was found to have a favorable risk/benefit ratio.

The CSM further revealed that despite the widespread use of SSRIs in children an estimated 50,000 in Great Britain alone only two of the seven antidepressants, Zoloft and Luvox, had been approved for use in children 18 years or younger who had been clinically (i.e., subjectively) diagnosed with obsessive-compulsive disorder (OCD). Whether the drug was effective could not be demonstrated for Zoloft, Celexa, Paxil and Effexor, and there were no data about the efficacy rate in Lexapro or Luvox, the mind-altering drug that one of the Col-umbine school shooters, Eric Harris, was taking at the time of his deadly assault.

Although the CSM report includes the seven major antidepressants on the market, two of them, Paxil and Effexor, were banned for children earlier in the year by the United Kingdom's regulating board. This same action was followed up in the United States when, in September, Connecticut's Department of Children and Families announced it would stop giving Effexor to children under the state's care because of the possible link to increased suicide risk. The FDA also took action in October of last year by putting out a public-health advisory "alerting physicians to reports of suicidal thinking (and suicide attempts) in clinical studies of various antidepressant drugs in pediatric patients with major depressive disorder."

Beyond the advisory, the FDA apparently is going one step further in its effort to ascertain whether there is a causal relationship between antidepressants and violence and self-harm. A special meeting has been scheduled for the first week in February in which members of the FDA's Advisory Committee, made up of experts from both its Psychopharmacologic Drugs Advisory Committee and its Pediatric subcommittee of the Anti-Infective Drugs Advisory Committee, will consider "optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action my be needed pertinent to the clinical use of these products in pediatric patients." In other words, the FDA intends to reanalyze data that was analyzed by analysts who conducted the clinical trials for each of the SSRIs in question.