Step right up, little lady, and get your serotonin selective reuptake inhibitors (SSRIs) to treat anything and everything that ails the mind and body--social phobias, eating disorders, insomnia, headaches and depression, to name but a few. This "medication," guar-an-teed safe and efficacious by the phantasmagoria of federal science, is prescribed to reduce the symptoms of whatever ails you and to assure healthy and happier lives.
Ah, but caveat emptor, my friend! A recent study conducted by Arif Khan, medical director of the Northwest Clinical Research Center in Bellevue, Wash., and adjunct professor of psychiatry at Duke University School of Medicine, has revealed startling numbers of suicides committed and suicides attempted in the clinical trials for the new SSRI antidepressants--numbers that for years had been hidden from both prescribing physicians and the public.
Kahn has examined the official clinical drug-trial data for all SSRIs approved by the Food and Drug Administration (FDA) between 1985 and 2000, in which 71,604 participants in the clinical trials were treated with antipsychotics, all SSRIs and anticonvulsants. The rate of suicides in the general public is 11 in 100,000, which means an incidence rate for those participating in the SSRI clinical trials of nearly 68 percent--that's 718 suicides for every 100,000. Kahn's research further revealed that nearly 4 percent of SSRI drug-trial participants attempted suicide within the following year.
Because people with a history of suicide are excluded from drug trials, the dramatically elevated drug-trial numbers revealed by Kahn raise important questions. Given the large number of attempted and completed suicides among drug-trial participants, why were these drugs approved by the FDA? Furthermore, since the new SSRIs are approved to reduce risk among depressed patients, does this data require a re-evaluation of the efficacy and safety of SSRIs?
Asked what the FDA considers an acceptable number of deaths in clinical trials, Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, tells INSIGHT, "Your question is not particularly pertinent because these trials are not designed to influence suicide. If you look at any one individual trial it is very unlikely you will find a suicide in the trial, and generally we don't."
You see, says Laughren, "It's only if you accumulate data across a large number of trials that you even have enough data to look at. What you do see in individual trials is that patients who get drugs improve more than patients who get placebo. That's what we see. When you do a meta-analysis across a large number of trials and you look at the other outcomes of suicide and attempted suicide, you don't see any particular benefit from being assigned the drug compared to placebo."
Which, of course, is the point. And Laughren further announced that "the drug is not approved for the treatment of suicide. They are approved for the treatment of depression. Dr. Khan's findings and our findings suggest that these drugs that we're studying and approving for depression don't appear to have a benefit on the outcome of suicide. That is not to say that they don't have a benefit in treating depression."
The drugs don't have a "benefit" on the outcome of suicide, which they in fact increase dramatically, but they do have a "benefit" for depression. How is this possible when in fact the clinical trials for SSRIs show the suicide rate increased by 68 percent?
"What this [increased suicide rate] would tell us," says Laughren, "is that this is a serious condition, not a trivial condition. Depression is a serious condition. If you look at individual trials there are so few suicides that you wouldn't be able to make sense of it all. It's only after you look across multiple development programs over a very long period of time that you have enough events that you can get this kind of analysis. …