On December 13, 2006, the FDA's Psychopharmacologic Drugs Advisory Committee will hold a public hearing to review the suicidality data from the adult selective serotonin reuptake inhibitor (SSRI) studies.
And, for what seems like the umpteenth time, SSRI experts from all over the US, and as far away as the UK, will travel to Washington to once again testify at yet another hearing on the suicide risks associated with these drugs.
The committee is expected to vote on whether the risk of SSRI-induced suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
The FDA should begin the hearing by announcing that suicide rates for adults have not declined at all in the US even with the massive wide-spread use of SSRIs. According to a Federal study, by researchers from Harvard Medical School and elsewhere, in the June 2005, Journal of the American Medical Association, despite a dramatic increase in treatment with antidepressants in 2001-2003, when compared to 1990-1992, the rates of suicidal ideation, gestures and attempts among adults have remained basically unchanged.
There is probably no legal expert in the US more qualified to testify about SSRIs than Baum Hedlund attorney, Karen Barth-Menzies, and she will be at the hearing with bells on. Over the past 10 years, she has represented thousands of clients against SSRI makers.
By now, the FDA knows that Ms Menzies makes no secret of the fact that she is outraged about the over-prescribing of these powerful and dangerous drugs to all age groups for nothing more than everyday problems.
This will be Ms Menzies' fourth time up to bat. She has already testified three times at government hearings. She first spoke at an FDA Psychopharmacologic Drugs and Pediatric Advisory Committee hearing in February 2004, about the increased risk of suicide in children and adolescents taking SSRIs.
At that particular hearing, the famous SSRI litigator concluded her testimony by telling the panel: "Put me out of business for the right reasons. Warn about these drugs."
Many of Baum Hedlund's clients who have suffered tragedies caused by SSRIs will be also be attending the hearing and some will be speaking. However, a number of clients who wanted to testify were not selected by the FDA's new "lottery" system, and will not be permitted to speak. But Ms Menzies says she plans to speak on their behalf.
She has first-hand knowledge of how the drug companies hid the evidence about the suicide risks. The documents that have been unearthed in litigation reveal that the risk was known in the mid-1980's before the first SSRI, Prozac, was approved for use in the US.
Because of Baum Hedlund's work in the Prozac litigation, Ms Menzies has the ability to provide the committee with the historical background on SSRIs, including internal company documents that show how and why the SSRI suicide risk with adults was obfuscated fifteen years ago during the first FDA advisory committee hearings on the suicide issue.
She will explain exactly how the clinical trial data was manipulated by SSRI makers to skew the statistical analyses of suicidality. "Civil lawsuits," she says, "have uncovered internal company documents to which not even the FDA has access."
And she maintain that the drug makers have purposely failed to conduct studies on the risk of suicidality because they already knew such trials would produce negative results.
In August 2004, Ms Menzies testified before the California State Senate and called for better patient informed consent about the risks associated with SSRIs.
Next, she testified at the September 2004, FDA Advisory Committee's follow-up hearings and discussed the lack of efficacy in SSRI treatment of children, as documented in pediatric clinical trials that had surfaced during litigation.
In between the February and September 2004 hearings, Ms Menzies met with members of Congress to discuss SSRI related suicidality and the FDA's failure to alert the public about the dangers of SSRIs, and provided documentary evidence to show that the risks posed were real.
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