Treatment Online

FDA Insists on Suicide Risk Assessment for Drug Trials
> 1/24/2008 3:23:45 PM

The blood-brain barrier is very good at keeping dangerous chemicals away from delicate neurons. The FDA positions itself as another barrier, one between the pharmaceutical companies and the consumers, and it has been successful in weeding out a high percentage of hazardous drugs. However, the FDA does let things slip through, and it even sometimes overlooks an entire category of risk. The New York Times broke a story today about a change in the FDA�s secret approval guidelines to require assessments for suicidal ideation.

In the past, the FDA has generally assumed that the blood-brain barrier makes it unnecessary to check drugs that don�t reach the brain for emotional and cognitive side-effects. They have come to realize that this simple rule does not always hold because drugs can indirectly affect other chemicals that can make their way to the brain and cause serious mental problems. Suicidal ideation has been a particularly grave side-effect that the FDA is only now recognizing. Though the furor over antidepressants allegedly causing suicidal ideation was overblown, it did serve the important purpose of clueing researchers in to the possibility that suicide risk can lurk in unexpected places. Since then, newly rigorous evaluations have revealed suicide risk in everything from smoking succession to weight loss drugs.

Many problems were overlooked in the past because suicide risk is very difficult to gauge. First of all, there is the controversy over whether suicidal ideation is a problem by itself, or whether attention should only be paid to suicide attempts or successful suicides. Secondly, it is much harder to record emotional disturbances than it is to measure something objective like weight gain. Researchers had no standard way to measure and thus it was also harder to combine their results in order to discover a pattern of risk. The earlier FDA investigation into antidepressants resulted in one good, which was the development by Dr. Posner of the Columbia Suicide Severity Rating Scale. This scale is now being used by most of the major pharmaceutical company in clinical trials.

For now, the FDA only requires a suicide-risk evaluation for drugs that have a reasonable possibility of provoking those problems, but that set of criteria has been set very wide by this recent change in policy. The body and brain are unfathomably complex, and it is good to see increased awareness of subtle chemical interactions. Consumers should feel more assured that the safety of drugs is being improved in step with their power.

Comments

No comments yet.