April 12, 2006

Schizophrenia Drug Research Bias

The Washington Post reported this week on a new academic study covered in the American Journal of Psychiatry that suggests there is a significant bias in research studies done by some pharmaceuticals companies. Specifically the newspaper reported:

Pharmaceutical giant Eli Lilly and Co. recently funded five studies that compared its antipsychotic drug Zyprexa with Risperdal, a competing drug made by Janssen. All five showed Zyprexa was superior in treating schizophrenia.

But when Janssen sponsored its own studies comparing the two drugs, Risperdal came out ahead in three out of four.

In fact, when psychiatrist John Davis analyzed every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study.

"On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis and others wrote in the American Journal of Psychiatry.

Drug effectiveness studies, such as these covered in this report, make up the majority of the evidence that American doctors rely on to prescribe $10 billion worth of antipsychotic medications each year. The Washington Post reported that "Davis pointed out the potential biases in design and interpretation that produced such contradictory results. Other experts note that industry studies invariably seek to boost the image of expensive drugs that are still under patent. Moreover, they say, the trials are relatively brief and test drugs on patients with simpler problems than doctors typically encounter in daily practice."

Drummond Rennie, deputy editor of the Journal of the American Medical Association suggested that "A perfectly independent agency has to be set up that says, 'Here are the areas where trials must be done,' " said . "There will be two classes of trials -- the believable ones and the non-believable ones."

The problem is not that companies fabricate results, experts say. Researchers, in fact, want drugmakers to sponsor more studies, not fewer. But ostensibly valid industry studies can be misleading in multiple ways, Davis said. Some use too low a dose of a competitor's drug, while others choose statistical techniques that show their drug in the best light. Virtually all test drugs on patients with relatively straightforward problems (which is not common in the real world). Davis further warned that the circular results he found could undermine the confidence of clinicians and patients, and even cast doubt on medications that are genuinely superior. He and Rennie also questioned academic researchers' role in these studies.

Read More - MSNBC Free Article (immediate access)


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