Shocking News Part II: Drug Studies Choose Study Sponsor's Drugs Posted by Rob Schneider at 04/12/06 01:19 PM

Unfortunately, I'm not feeling particularly shocked to learn about a new analysis showing that, in head-to-head trials of drugs, the studies conclude that the best drug happens to be the drug made by the study's sponsor. The findings again raise the question of whether we can count on drug companies to provide physicians, the public, or even the FDA with unbiased information when the financial success of their medicine is at stake.

The Washington Post covered the release of the analysis that occurred in The American Journal of Psychiatry. The Post summarized the results:

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.

The analysis focused on antipsychotic medicines. Doctors prescribe $10 billion of these annually, and they rely primarily on drug company-sponsored studies as the evidence backing up their prescribing decisions, according to the article.

What are the systemic problems that underlie drug company-sponsored drugs?

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.

The story contrasts manufacturer-sponsored studies with those done by the federal government, which is less likely to have a dog in the hunt. The federal government studies that compared a broader range of treatments for schizophrenia identified two drugs not under patent -- and far cheaper -- as standouts.

Increasingly, there have been calls for moving drugs studies away from companies to entities without a stake in the outcome. This has been mentioned as one way to assure Phase IV -- post market -- studies are performed after FDA approval of a medicine. No doubt, having an independent body do drug studies might go a long way toward restoring public -- and increasingly medical professional -- confidence in drug makers and drug regulation.

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

Truly objective drug studies -- not those sponsored by companies that have their financial future riding on the outcome -- would help a lot. But it would probably mean no one would even bother with, as JAMA's deputy editor put it, the "non-believable ones."

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