Saturday, July 28, 2007

FDA Black Box Warning and Increase in Teen Suicide

The FDA issued a black box warning about SSRI's causing suicidal ideas. Perhaps, they occurred in 2% of placebo patients and 4% of SSRI patients. The counts included trivial self-injuries such as slapping oneself. No suicide took place in any reviewed study.

As a result of such warnings, pediatricians and general practitioners decreased their prescribing of the SSRI's. Psychiatrists, with more knowledge and confidence, ignored this idiotic black box warning. As a result of the decrease in total prescriptions to adolescents, the suicide rate stopped dropping, and for the first time in decades, increased. There have been 100's of needless, excessive suicides in teens, as a result.

Now, if one my decisions kills 100's of people, I should resign from my job. No? I made that point to a friend on that FDA Advisory Committee.

He replied. The Committee faced 80 raucous, threatening witnesses with extreme views. These included left wing ideologue doctor wackos. They included grieving parents blaming SSRI's for their child's suicide. They included parents of Columbine victims blaming SSRI's for the massacre.

The Committee faced loud calls for the banning of SSRI's entirely. The black box warning represented a middle ground decision made in the face of horrendous bullying.

The irresponsible bullies and wackos who testified now have blood on their hands. Beyond the few children murdered at Columbine, these vicious, bullying, scapegoating, misleading Columbine parents now assassinated a number of children 100's of times greater than the Columbine mass murderers.

SSRI's boost serotonin. It inhibits dopamine. Dopamine inhibition causes restlessness and an irritated mood that are very uncomfortable. People punch walls, drive at 120 mph, and can't stop yelling in order to get relief. If one has not been warned of agitation as a side effect, and one is depressed and impulsive, one does not tolerate the discomfort.

One should warn patient that 1 in 30 patients gets agitated, most likely the first day, and that the drug should be stopped.

Is there such a really useful warning to that effect? No.

When left wing ideologue doctor wackos, and vicious, vengeful parent bullies prevail at a hearing, 100's of innocent teens die, and the really useful warning does not appear.

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