Six years after Kip Kinkel, dosed up with Prozac, killed his parents and two students at Thurston High, in Oregon; five years after Eric Harris, dosed with Luvox, embarked on his day of slaughter at Columbine; well over a decade after naysayers, including Dr. Peter Breggin, the Scientologists and this columnist, raised the alarm about links between antidepressants and violence, the FDA has issued a warning that ten antidepressants can cause deeper depression and, for gosh sakes, even agitation, mania and other forms of violent behavior, even SUICIDE! Who says government doesn’t work?
The FDA issued this ruling on March 22, and it applies to Prozac, Zoloft, Paxil, Luvox, Lexapro, Effexor, Remeron, Celexa, Wellbutrin and Serzone. Since the FDA cocks a nervous eye at such important constituencies as the pharmaceutical industry and its political reps in the White House and Congress, it is cautious about overhasty and tasteless prying into cause and effect. The FDA says it isn’t yet clear whether antidepressants contribute to the emergence of suicidal tendencies, such as those that prompted Bill Forsyth, after several days on Prozac, to kill his wife, then himself. To move toward any conclusions in this issue, the FDA will be re-examining data compiled by analysts who conducted the original clinical trials for each of the products (technically, selective serotonin reuptake inhibitors, or SSRIs) about which warnings have now been issued.
So there’ll be a pause, during which time the FDA can fend off concerns with comforting talk about “thoroughgoing reviews” and the drug companies can continue to mine their usual extortionate markups from the antidepressants, for which 213 million prescriptions were issued in the United States in 2003.
The actual review will probably end up with a ringing affirmation of the diligence of the FDA’s procedures. In an excellent recent article in Insight, Kelly Patricia O’Meara quoted an attorney, Karen Barth Menzies, who has represented victims of SSRIs. According to Menzies, “the FDA’s planned methodology…is to go back and look at the number of suicide events that were recorded during the drug companies’ clinical trials…. The only thing that can come from this panel’s review of the data is that they get the same number or fewer [my emphasis] incidents of suicide events which now will be based on the panel accepting that the researchers’ evaluation was correct.” You follow?
The FDA only lifted its backside momentarily off the cushion of complaisance because the British Committee on Safety of Medicines concluded last year that the “risks of treating depressive illness in under 18s with certain SSRIs outweigh the benefits of treatment.” Zoloft, Celexa, Paxil and Effexor were impugned, though Prozac got a thumbs-up as having a favorable benefit-risk ratio, a conclusion that some have found astounding. A large-scale study of 2,770 patients on antidepressants featured in the British Journal of Psychiatry found that fluoxetine (Prozac) had the highest risk of deliberate self-harm. Menzies told Insight that in her view Prozac got excluded by the British committee because Lilly has “been dealing with this issue a lot longer and they’re a lot better at hiding evidence of a causal link between suicidality and Prozac.”