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STUDY HIGHLIGHTS NEED FOR COMPARATIVE DRUG REVIEWS

October 4, 2006

The fact that the newest generation of antipsychotic drugs used to treat schizophrenia is no more effective than earlier, less expensive treatments illustrates the need for a national dialogue about comparative effectiveness between drug classes, an academic says.

A study funded by the UK's National Health Service, and published in the October edition of the American Medical Association's Archives of General Psychiatry, found that second-generation antipsychotics (SGA) are no more effective in improving schizophrenics' quality of life than their older counterparts and therefore do not justify their higher costs. "The results of this pragmatic randomized trial refute the hypothesis that the use of SGAs is superior to the use of" first-generation antipsychotics, the study concluded.

But Eli Lilly, the maker of Zyprexa and Symbyax, two of the drugs featured in the trial, downplayed the study's results. "We differ with the assumption made by the researchers of this study that all [second-generation drugs] work the same," a Lilly spokeswoman said. "We know that based on real-world evidence and multiple other studies that these drugs do differ in terms of efficacy and side effects." Zyprexa was the 16th highest selling drug in the U.S. in 2005, based on retail sales.

Antipsychotics are one of the fastest growing categories of drugs, with the Social Security Administration disability benefits for these treatments growing by 35 percent between 1994 and 2003. As of 2005, 90 percent of patients with schizophrenia received SGAs at a cost of $10 billion annually, according to a commentary that accompanied the study.

Robert Rosenheck, a professor at Yale University's Department of Psychiatry and the author of the commentary, says these newer drugs cost as much as 100 times more than earlier antipsychotics, without much difference in efficacy. But this study should not lead to wholesale policy changes, Rosenheck said. "These unexpected empirical findings should not lead to a precipitous turn away from policies that support open formularies for psychotropic drugs."

Instead, there should be a broad public dialogue on this issue before such a drastic step is taken, he said. "Polarizing decisions are best delayed until thoughtful public deliberation gives a chance for comprehensive review, consensus building and shared understanding."

(http://www.fdanews.com/did/5_194/)