Blog | Monday, May 4, 2009

Researcher's disclosures plant seed of doubt


With conflict of interest issues so much in the news, one can't help but wonder about the integrity of certian studies. When researchers disclose ties to companies that stand to benefit from a study's conclusions, how can the results--however valid--not be tainted?

A case in point: An article in MedPage Today reports that research presented recently at the American Urological Association meeting in Chicago concluded that switching patients from brand-name to generic urologic drugs resulted in lower efficacy and more side effects.

The article dutifully points out that while generic drugs must be FDA approved as bioequivalent to the branded versions, the U.S. definition of bioequivalence encompasses a fairly wide range, from 80% to 125% of the active compound, thus opening the door to differences in efficacy.

The two small observational studies showed that control of lower urinary tract symptoms decreased by as much as 42.5% when patients were switched to a generic alpha-blocker or 5 alpha-reductase inhibitor (5ARI) from a brand-name drug.

Cause for concern? Maybe, but one can't help but wonder when the researcher, Steven A. Kaplan, M.D., of Weill Cornell Medical College, discloses relationships with several makers of the branded drugs used in the study (Detrol by Pfizer, Uroxatral by Sanofi, Vesicare by Astellas Pharma and Avodart by GSK). "Patients and their physicians need to be aware of the implications of switching to generic medications," Dr. Kaplan told MedPage.

We might add that it also pays to read the fine print.