One of the largest studies ever conducted on antipsychotic medication—the CATIE Trial—was compromised by crucial input from the pharmaceutical industry, and the study’s results may not be valid as a result, according to The Carlat Psychiatry Report.
Newburyport, MA, March 1, 2006—According to an analysis conducted by The Carlat Psychiatry Report, a huge NIMH study on antipsychotic medication was compromised by the pharmaceutical industry, throwing its primary conclusion into doubt.
Antipsychotic medications represent a $10 billion market for the pharmaceutical industry, and several companies compete for industry dominance. The most profitable of these medications are the atypical antipsychotics, newer but expensive drugs that are considered to cause fewer side effects than older antipsychotics, such as Haldol.
In order to evaluate whether atypical antipsychotics have any real advantages over cheaper alternatives, the NIMH (National Institute of Mental Health) recently released results of Phase 1 of the “CATIE” trial. Because this study was funded entirely by the government, rather than industry, its results have been thought to be trustworthy.
The study concluded that Zyprexa (olanzapine, Eli Lilly) was “the most effective in terms of rates of discontinuation,” the major outcome measure used in the study (published in the New England Journal of Medicine, Sept. 22, 2005).
However, according to an analysis conducted by The Carlat Psychiatry Report (www.TheCarlatReport.com), Zyprexa was put at an advantage in comparison with the other medications studied, because it was dosed much higher.
The methodology of the study allowed pharmaceutical companies to dictate the number of milligrams of their product put in each capsule. According to the February 2006 issue of The Carlat Psychiatry Report, “The most shocking result of the CATIE dosing protocol is that the average Zyprexa dose was higher than the PDR-listed maximum, while the average dose of all its competitors was less than half of the PDR maximum dose.”
The PDR (Physicians’ Desk Reference) is the major source of official information on FDA-approved medications.
“The bottom line,” according the report, “is that a strong case can be made that Zyprexa’s apparent efficacy advantage in the CATIE trial is merely an artifact of the way it was dosed relative to the other medications.”
The Carlat Psychiatry Report, a monthly newsletter widely read by U.S. psychiatrists, is edited by Daniel Carlat, M.D., an assistant clinical professor of psychiatry at Tufts University School of Medicine in Boston, MA.
The full text of the article can be found at www.TheCarlatReport.com.
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