Clinical Depression In Teens?
Q.experts had access to clinical trials performed by pharmaceutical companies that were previously confidential. At a 1991 hearing on the safety of Prozac in adults, doctors had reviewed only the limited number of studies that the drug companies had chosen to publish. That panel voted, 6 to 3, that Prozac and similar drugs were not connected to suicidal behavior.
A.It has always been the case. As long as we have had pharmacological treatment of depression, induced suicide has been a fact of the treatment. The incidence has been stable across all treatment modalities. The major spur for the development of antidepressant drugs that were not toxic in overdose came from the near absurd paradox that tricyclics offered as treatment for depression were a convenient and often fatal means of attempting suicide. The most obvious characteristic of SSRIs, when they were developed, was that massive overdose did not kill. Read the literature of the day. You have to investigate the thinking of the time period itself. I really think that that non-fatal overdose factor was the primary trigger for the "miracle drug" aura that surrounded the drugs, early on. We also must consider that the manner in which clinical trials are conducted has undergone massive revision over the last decade or so. The old clinical trial data are much like an anachronism. We cannot fairly assess them if we view them solely through our more enlightened eyes of today. It is clear to anyone who understands clinical trial methodology that a lot of what passed for scientific testing sometimes only a decade ago is really poor science. Re-examining the actual clinical trial data may reveal new findings, but those new pieces of evidence are not untainted by the poor methodologies themselves. If the principle intent of a clinical trial was to determine efficacy, then all the control of variables was focussed on that measure. There was an a priori primary outcome measure. There were often secondary measures, but those should not and could not be used to over-ride the primary outcome, whatever it might be. Any other data collected has to be considered to be uncontrolled. "Considering the benefit and the risk, we think this preparation totally unsuitable for the treatment of depression" - May 25th 1984 communication to Lilly US from Lilly Bad Homburg by B v.Keitz containing a translation of an unofficially received medical comment on the Fluoxetine application to the German regulators." It was not until this year that data from unpublished clinical trials on children by Paxil's maker, now called GlaxoSmithKline, convinced British and American regulators that there was a scientific basis for the concern about suicide in teens. "It's a huge breakthrough," said Jessica R. Dart, an attorney with a Los Angeles firm that has represented dozens of patients against Paxil's British maker, GlaxoSmithKline UK. "It almost didn't feel real. They have been denying this for years and years." Those studies were submitted as part of an FDA initiative to review the effects on teens of all drugs such as Paxil and Prozac, known as selective serotonin re-uptake inhibitors, or SSRIs.
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