REPORT ASSERTS THAT NIMH TRIAL RESULTS WERE BIASED

The U.S. National Institute of Mental Health's (NIMH) comprehensive CATIE trial, which compared several antipsychotic drugs, was largely compromised by pharmaceutical industry input, according to the Carlat Psychiatry Report, a monthly publication on psychiatric practices and treatments.

The CATIE trial evaluated whether atypical antipsychotics -- new, more expensive medications that are thought to cause fewer side-effects than older drugs -- showed any real advantages over cheaper medications. Phase I of the trial, first published in the New England Journal of Medicine in September 2005, concluded that Eli Lilly's schizophrenia treatment Zyprexa (olanzapine) did, indeed, produce fewer adverse reactions, citing that it was "the most effective in terms of rates of discontinuation."

The Carlat Report, however, claims that Zyprexa was given an unfair advantage, noting that the drug was dosed at much higher levels than other drugs involved in the study. Since pharmaceutical companies control the amount of active ingredient that is contained within a medicine capsule, this aspect of the trial, notes the report, raises ethical concerns.

"The most shocking result of the CATIE trial," states the report, "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 A strong case can be made that Zyprexa's apparent efficacy advantage is merely an artifact of the way it was dosed."

The market for antipsychotic medications is estimated at $10 billion, with atypical antipsychotics remaining the most profitable subcategory.