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Unpublished drug data and how you look at it

September 23, 2008 | 12:01 pm

Newpharmacist

Good luck trying to find as much information as possible about medications approved by the U.S. Food and Drug Administration. More than half of the clinical trial data supporting those drugs remains unpublished five years after the medications' approval, researchers at UC San Francisco have found.

The importance of a trial was a factor, they point out. In a review published, and available in full, at PLoS Medicine, the authors say:

"For pivotal trials, which are more clinically informative than nonpivotal trials, we found publications from 76% of the trials. For one of the 90 approved new drugs, we could not find any published supporting trial. We also found strong evidence of publication bias: trials with statistically significant results were more likely to be published than trials with nonsignificant results, as were trials with larger sample sizes."

As consumers, we might like to think that such information is readily available for all to review, for better or worse. That's obviously not the case.

Says Scientific American: Medical studies about drugs may be victims of spin, says report

Says the blog Pharmalot: Most failed clinical trials are never published

But notes Respectful Insolence at ScienceBlogs:

"You just know that a woo-meister somewhere will point to it as 'evidence' that scientific medicine is hopelessly corrupt. ... This study means nothing of the sort. If anything, that this study was published in such a prominent journal is strong evidence of the very thing that makes scientific medicine so much superior to the methods of woo-meisters: its self-correcting and self-criticizing nature."

The situation should improve somewhat, the new study's authors point out. The FDA Amendments Act of 2007, which requires the reporting of basic results for all FDA-approved devices and drugs, is expected to make information more readily available ... but possibly increase publication bias.

-- Tami Dennis

Photo: Pharmacist Robert Fox fills prescriptions in Downey.

Credit: Alex Gallardo / Los Angeles Times

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