September 16

ADDENDUM: Scientifically Invalid SSRI Study

Friday’s Infomail neglected to point out an important acknowledgement by one of the lead authors of a widely cited, seriously flawed study.

The disputed study was funded by the National Institute of Mental Health and Pfizer, manufacturer of the antidepressant, Zoloft (Sertraline)  and published in the official journal of the American Psychiatric Association [Am J Psychiatry, 2007;164:1356-1363].

The authors reported a sharp 8% increase in suicides among youth (aged 10 to 24) between 2003 and 2004, the largest single-year increase in 15 years. They attributed the rise to reduced antidepressant prescriptions for that age group following FDA-required Black Box warnings that went into effect in 2005.

The uncritical press broadcast industry’s propaganda, not even checking whether the dates coincided.

In October 2004, Pfizer’s direct to consumer Zoloft advertisements –such as appeared in The New York Times magazine–failed to include ANY of the FDA required warnings.

Indeed, as late as December 23, 2004, SSRI drug manufacturers were still haggling with the FDA about the wording of the warnings.
Not until 2005, did the companies actually add Black Box warnings acknowledging that evidence from controlled trials links these drugs to increased risk for suicidal acts.

This is but one of the obvious facts contradicting the claims made by authors whose financial ties to drug manufacturers may have skewed their conclusions. [1] [2] Their claim that lowered prescribing of antidepressants resulted in a higher suicide rate among teens is not supported by any evidence, including their own. 

Indeed, when pressed by independent scientists who dispute the unfounded conclusions, Dr. Robert Gibbons, the lead author, acknowledged in the New York Times that: "the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004."  He stated: “We really need to see the 2005 numbers on suicide to see what happened.” 

Actually, those numbers would still not provide scientific evidence of a causal relationship inasmuch as the aggregate data is non-specific and not controlled for confounding variables.

Dr. J. John Mann, the other lead author, an influential psychiatrist at Columbia University and the New York State Psychiatric Institute, persists in holding fast to a cause and effect relationship. He told the Times: “The most plausible explanation is a cause and effect relationship: prescription rates change, therefore suicides change.”

One is reminded of the rooster who believes that his crowing causes the sun to rise.

In fact, the AJP authors do not know whether those who committed suicide were either depressed or had been prescribed antidepressants, antipsychotics or a toxic combination of psychotropic drug cocktail–as is the current fashion among psychiatrists! 

When scientists are for sale and "peer reviewed" journals publish planted commercial pronouncements masquerading as "science" news reports, the public is advised to disregard those "news" reports and wait for the evidence to be independently examined and either corroborated or refuted. 

The Authors’ Financial Conflicts of Interest::

1. Robert D. Gibbons, director of the Center for Health Statistics and professor of biostatistics and psychiatry at the University of Illinois, in Chicago. Industry Affiliations disclosed here, here , here , here and here :

Has served as an expert witness for Wyeth Pharmaceuticals, makers of the antidepressant Effexor. 

2. J. John Mann MD, the Paul Janssen Professor of Translational Neuroscience in Psychiatry and Radiology, Columbia University College of Physicians and Surgeons; Chief, Department of Neuroscience, New York State Psychiatric Institute.
Longstanding Industry Affiliations disclosed here :

•    Consultant and expert witness: GlaxoSmithKline, Pfizer, 2000, 2001 (lamotrigine; Zoloft)

•    Participated in GlaxoSmithKline Advisory group meeting on lamotrigine (2002);

•   Grants/Research Support: PET ligand development grant from Pfizer (2003), Beta-amyloid imaging grant from GlaxoSmithKline (2005)

    Received three years of funding from Janssen Pharmaceutica for research involving all suicide victims in a region of Hungar; 

•    Received funding from Eli Lilly for a study on the safety and biological mechanisms of action of norepinephrine and serotonin reuptake inhibitor antidepressants (1990). 

Contact: Vera Hassner Sharav

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