Tuesday, January 29, 2008

Irresponsible, Lethal FDA at It Again

This agency must be eliminated by law.

These peddlers of garbage science now want to have many more suicide assessments, even in non-psychiatric medications. They will mandate suicide assessments in trials for medications for medical conditions. "Medicines to treat acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia can all cause psychiatric problems, effects that were discovered in most cases after the drugs were approved and used in millions of patients." (from this NYT article. Thanks to Simon Levane.)

They will impose this suicide assessment.

Where is the evidence that this bogus assessment can detect, lower, or have any effect on the suicide rate? If these geniuses impose this screening, and a difference emerges from the rate of suicidality in the placebo group, then the excess number should be evaluated for ecological risk factors. Relational, familial, and extra-familial factors must be controlled for before attributing any excess risk to drug treatment. This control for external factors is mandatory because the randomization assumption is always violated by any exclusion criterion.

As this bogus paper shuffling is added to the treatment of the conditions covered by this unfunded mandate, more doctors will be deterred from using these medications. As they forego these treatments and reject these patients, far more patients will die of the underlying condition. For example, the peddlers of garbage science have alleged acne medication caused suicides. People with acne have a high rate of suicide. When ascertaining the baseline rate, acne medications reduce the suicide rate. A lawyer used his position of power in Congress to scapegoat the medication for the intentional suicide of his son. Instead of looking at the real factors, he chose to scapegoat the medication. By preventing its use in some people, this peddler of garbage science may have increase the suicide rate in other people with acne, now untreated.

If anyone hears of any plaintiff expert promulgating garbage science in form of the suicide assessment, or in the form of a link between these medications and suicide, please, let me know the case.

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