FDA & suicide

I haven't decided whether it's good or bad (I lean to the latter) that the FDA recently announced "findings" in studies involving antiepileptic drugs an increased report of suicidal ideation.

An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving placebo (0.22 percent). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.

Keep in mind, these are not big numbers. But when it comes to risk ratios, for researchers, it's the comparison that matters (0.43 vs. 0.22). It translates to twice the risk!

Scary! Fear! Boogeyman!

It would not be surprising--given FDA is inherently political despite their best intentions--that soon research studies involving any antiepileptics will require procedures for addressing situations in which subjects exhibit suicidal thoughts. Again, I'm not convinced this is bad necessarily, but it is yet another issue researchers will need to be aware of when preparing their research applications and another item to be added to the consent form.

As far as suicide procedures, this is what IRBs like to see:

- A qualified individual should evaluate all subjects whose responses indicate that they may be suicidal.

- Potentially suicidal subjects should be referred for appropriate clinical care. Please outline your procedures for ensuring that all potentially suicidal subjects are provided with referrals for appropriate clinical care.

- If a subject is acutely suicidal, they should be transported to the emergency room by trained personnel and a trained member of the study staff should remain with the subject until they have been transferred.

And then, in the consent form, languages something like this:

In the event that you tell the research staff that you are thinking about killing yourself or you answer “yes” to a question about having thoughts about suicide, the investigator will ask you more questions about the thoughts. Depending on how intense your thoughts are or how much you feel like hurting yourself, the research staff may provide you with referrals for treatment, work with you to contact your personal physician, trusted family member, or therapist to discuss your thoughts of harming yourself; or work with you on a plan that may include getting you to a hospital for safety.

Don't hate me me for this. If and when the time comes, complain to the FDA.