By ALEXANDER COCKBURN, www.counterpunch.orgSix 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 nay-sayers including Dr Peter Breggin, the Scientologists, and this columnist raised the alarm about links between anti-depressants and violence, the FDA has issued a warning that ten anti-depressants 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 21, and applies to Prozac, Zoloft, Paxil, Luvox, Lexapro, Effexor, Wellbutrin, Serzone Remeron and Celexa. Since the FDA cocks a nervous eye at such important constituencies as the pharmaceutical industry and that industry's political reps in the White House and Congress, it is cautious about over-hasty and tasteless prying into cause and effect. The FDA says it isn't yet clear whether antidepressants contributed 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 towards any conclusions in this issue the FDA will be reanalyzing 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 "a thorough-going review" and the drug companies can continue to mine their usual extortionate mark-ups from the anti-depressants, for which 213 million prescriptions were issued in the US in 2003. One estimate has 30 million Americans on anti-depressants, with Zoloft in the lead at 32.7 million dispensed prescriptions in 2003 and Prozac loping along in second place with 22.2 million.
The actual review will probably end up with a ringing affirmation of the diligence of the FDA's procedures. In an excellent article in Insight (Feb 17-March 1) Kelly Patricia O'Meara quoted an attorney, Karen Barth Menzies, who has represented victims of SSRIs. According to Menzies, the FDA's planned methodology will be to go back and look at the number of "suicide events" 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 caps) incidents of suicide events which will now be based on the panel acceptiong that the researchers' evaluation was correct." You follow?
And no, the FDA will not release the names of the "independent experts sitting on the panel who may or may not have ties (i.e. boatloads of research funding) from the pharmaceutical companies whose procedures they are scrutinizing. On one advisory committee mustered over a decade ago by the FDA to take a look at Prozac five of the eight members had serious conflicts of interest , including financial backing from Lilly, the drug company selling Prozac.
The FDA only lifted its backside momentarily off the cushion of indifference because the British Committee on Safety of Medicines concluded last year that the "risks of treating depressive illness in under 18s with certain SSRIs outweighs the benefits of treatment". Zooft, Celexa, Paxil and Effexor were found to increase the rate of self-harm. 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 anti-depressants 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 Eli Lilly has been dealing with the issue a lot longer and "they're a lot better at hiding evidence of a causal link between suicidality and Prozac."
On this point Menzies knows what she's talking about. At the Forsyth trial her law firm got hold of internal Lilly documents displaying a distinct aversion to truth on the vexed business of suicidal ideation. Back in 1986, a draft of proposed "Precaution and Adversion Reactions" on a Prozac package contained this sentence, briskly edited out of the final edition: "Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy." Another memo in 1992 showed one Lilly employee confiding to another: "re Adverse Drug Event Reporting Suicide Fluoxetine: 'I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation.'"
I don't see any way the pharmaceutical anti-depressants will take any serious long term hit from the FDA warning and impending review. It's like going after the cement and highway lobby. There's just too much money involved. In the case of "depression", a vast new territory opened up for exploitation after the economy peaked in the mid-60s, and people stopped drinking dry-martinis, the money is strung out along a golden conveyor belt that stretches all the way from the American Psychiatric Association's definitions of neurotic and psychotic conditions in the periodically issued Diagnostic and Statistical Manual, which end up sanctioning medical reimbursements for drug therapy.
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