That Controversial SSRI Study

I finally got my hands on a copy of the study in the American Journal of Psychiatry that claimed that a recent increase in youth suicides can be tied to psychiatrists dialing back on their use of anti-depressants in the wake of a Food and Drug Administration warning in 2004 that the drugs may actually increase suicide idea formation in youths. The Centers for Disease Control in a separate report confirmed the trend, if not the conclusion.

What struck me in looking at the data was how small the change was (14 percent doesn't seem small, but look at the raw numbers). The rate went from 2.83 per 100,000 or 1,737 suicides in a population of 61.45 million youths 19 and under in 2003 to 3.23 per 100,000 or 1,985 suicides in a population of 61.47 million youths in 2004, according to the study. The CDC data covered young people up to age 24 and showed a smaller increase in 2004, going from 6.78 to 7.32 per 100,000 youths, an 8 percent uptick. The CDC did note that this was the largest percentage increase since at least 1990 when the CDC began tracking the data.

However, looking at either set of numbers, the 2004 rate remained in the relatively low range that it has been in since the late 1990s. Youth suicide rates began falling in 1988 when, some argue, illegal drug use among youths began declining and legal drug use (various forms of speed for ADHD and serotonin reuptake inhibitors or SSRIs for depression) began its long-term upswing.

Critics of anti-depressants say the real danger period when using these drugs comes when kids start taking them and when they stop taking them. As one put it today: Taking these drugs is like riding the space shuttle; the riskiest part of the journey is going up and coming down. That theory suggests that one year blip in response to a downturn in prescriptions may have been related to drug withdrawals.

In any case, a one year change in a curve's direction doesn't a trend make. The danger signal from anti-depressants in kids that were highlighted by Food and Drug Administration reviewers in 2004 came from controlled clinical trials. This study's broad conclusion, "If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect," is based on a crude correlation based on a small one-year shift in broad population data.

The study's chief author was Robert D. Gibbons, a professor of psychiatry at the University of Illinois. His conflict-of-interest disclosure at the end of the study (not revealed in the Washington Post article) reported that he also provides expert testimony in product liability trials for Wyeth Pharmaceuticals, which makes Effexor, an antidepressant in the SSRI class.

It takes a lot for the FDA to ignore clinical trial results in favor of population-based studies like this one. FDA psychiatry drug chief Thomas Laughren was properly circumspect in today's Post: "FDA is obviously concerned about possible negative impacts of labeling changes but also feels a strong obligation to alert prescribers and patients to possible risks associated with the use of antidepressants." He added, "We will continue to monitor antidepressant use and suicide rates, and will take appropriate regulatory actions as new data become available."