Washington DCThe FDA's Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.
The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:
"The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category.
"But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.
"The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it - that is not too surprising - it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it."
Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.
Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.
"Through our Paxil litigation," Ms Menzies says, "we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," Ms Menzies says.
"The manufacturers of the SSRIs," she states, "have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the 'disease.'"
"This is notwithstanding clear evidence," Ms Menzies says, "very early on in the clinical trials of these drugs that they can cause these problems."
"We have documents," she notes, "obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country."
Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.
After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.
She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.
Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.
In fact, she gave one presentation that directly addressed the FDA's mishandling of the SSRI matter titled, "Federal Preemption - How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect" - SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.
Another one of the world's most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.
Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. "We have here," he says, "the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other."
"The divide," he says, "it is important to note, only came to light as a result of the efforts of journalists and lawyers."
"No clinician or scientist had a hand in questioning the validity of the 'science'," he points out.
The most famous fraudulent study involving SSRIs is GlaxoSmithKline's study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally "labile" while taking the drug.
"In the published version of 329," Dr Healy points out, "suicidality vanishes under a carpet of emotional lability."
Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. "The question of what was happening to children," Dr Healy says, "deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators."
As a result of Glaxo's application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.
"Within a fortnight of seeing the raw data in May 2003," Dr Healy says, "after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors."
A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.
"This reassessment of the data does not however represent a triumph of scientific method," Dr Healy says, "it indicates rather a crisis triggered by media concerns."
The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.
By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.
After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, "Talking Back to Prozac," and "The Anti-Depressant Fact Book."
After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.
Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: "During the treatment with the preparation 16 suicide attempts were made, 2 of these with success."
"As patients with a risk of suicide were excluded from the studies," the document says, "it is probable that this high proportion can be attributed to an action of the preparation."
In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:
"The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable."
On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly's request that he change the event "suicidal ideation" to "depression," Mr Bouchy writes:
"Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.
"I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation."
A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: "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."
The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, "Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation."
On February 7, 1990, a Leigh Thompson memo also says, "I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that."
Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.