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The Big Suicide Loophole in Antidepressant Drug Safety Studies
By Peter R. Breggin, M.D.
On December 13, 2006 the FDA’s Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.
Now the agency has given advanced notice of its new findings — antidepressants, all of them, according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.
First the agency admits that antidepressants cause suicidality in children. Now the agency admits the drugs cause the same disasters in young adults. Meanwhile, an independent review of all antidepressant trials submitted to the FDA has shown that the drugs are no better than placebo.[i] America’s drug watchdog needs to come clean. It’s been approving depressants as antidepressants.
The Largest Loop Hole
But it gets worse. The primary data on suicidality has been generated in short-term controlled clinical trials planned by drug companies, carried out by drug company hacks, and evaluated by drug company employees at corporate headquarters. If that kind of carefully cultivated evaluation bears such bad fruit, imagine what the real data must show.
Since I first began working as a medical expert in product liability cases way back in the early 1990s, I’ve spent innumerable hours culling the sealed data contained within the files of companies like GlaxoSmithKline and Eli Lilly. Among other things, I long ago found evidence that Paxil and Prozac cause suicidality in adults. These discoveries then led to settlements in product liability suits brought against the two companies brought by surviving family members. I’ve also communicated my conclusions in books like Talking Back to Prozac and the Antidepressant Fact Book and in scientific articles but the primary data until recently remained sealed.
Drug-company-groomed data creates the biggest loophole in the FDA’s evaluations of drug safety. In May 2006 GSK published a 'Dear Healthcare Provider' letter admitting that Paxil causes suicidality in depressed adults, but even that data was diluted before it was processed. The real picture is even worse.
Paxil Suicide Data Sealed in Company Files
I recently published analyses of previously sealed GSK data on Paxil suicide in the journal Ethical Human Psychology and Psychiatry. I combed the data out of GSK files during a several-day investigation of the company’s Paxil records. My original medical/legal report recently became unsealed and provided the basis for the published reports.
The first report shows how GSK omitted some suicides and suicide attempts from their tables and from the data sent to the FDA.[ii] The second shows how the company hid data on Paxil-induced akathisia (psychomotor restlessness) and its relationship to suicidality.[iii] The third shows how the company hid the basic concept of activation or stimulation that recently became a central part of the newly mandated antidepressant labels.[iv]
Prozac Suicide Data Sealed in Company Files
The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. The British Medical Journal (BMJ) recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress. [v].
Parts I to III show that the drug company knew in 1985 that patients taking Prozac had a 12 to1 increase in suicide attempts compared to placebo or to an older antidepressant. This original data and the analyses were never shown to the FDA until the BMJ recently forwarded them to the agency. The FDA has never responded.
Part IV contains several studies. Most important, two in-house memoranda show that Eli Lilly was purposely hiding suicide attempts and suicide ideation by coding them under false categories, such as “depression” and “no drug effect” (cf pp 3 and 4 of Part IV). Eli Lilly employee Claude Bouchy expressed shame about going along with this fraudulent practice: “I do not think I could explain to the BGA [the German regulatory agency], to a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicide ideation.”
The data used to evaluate antidepressant-induced suicidality in adults is not reliable. This is a fact the FDA has yet to face. The data has been pruned, culled and manipulated by the drug companies before being tabulated and released. The FDA must send investigators into the original drug company files to search and analyze the primary sources of data, much as I have done as a medical expert in product liability suits against drug companies. I will be happy to share my knowledge with FDA officials on how to conduct these searches and analyses.
[i] Kirsch, I. and Sapirstein, G. "Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication." Prevention & Treatment, 1, Article 0002a,
[ii] Breggin, P. (2006a). Court filing makes public my previously suppressed analysis of Paxil's effects. (PDF)
[iii] Breggin, P. (2006b). How GlaxoSmithKline suppressed data on Paxil-induced akathisia. (PDF)
[iv] Breggin, P. (2006c) Drug Company Suppressed Data on Paroxetine-Induced Stimulation. (PDF)
[v] Lilly Documents, Folders 1-4 (2006). The Eli Lilly Prozac Suicide and Violence Documents: An Analysis. (PDF) and An Examination of Eli Lilly and Co's Contention that the BMJ Prozac Documents were Never Missing.