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Transparency & Clinical Trials

by John Moore | December 12, 2008

This morning’s WSJ’s Science Journal takes a particularly harsh and somewhat uncharacteristic (at least for WSJ) look at the pharmaceutical industry’s practice of sequestering less than favorable clinical trials’ results.  Appears that the sheer volume of clinical trials today, 50K ongoing among some 2.3M patients creates an enormous amount of data and subsequently reports.  What researchers have found, at least according to the article, is that the vast majority of results are never published.

Surprise, surprise, the vast majority of research that never sees the light of day (75% according to one study) are unfavorable results.

Making matters worse, of those that are published, quite a bit of “creative editting” occurs to insure that clinical trial results are cast in the most favorable light.

What I can not fathom though is why the author of this article did not bother to talk to any payers to solicit their perspective on the issue. Ultimately, they are often the ones that do the comparative effectiveness analysis of a new drug. Do not fully understand why they are not on top of this issue themselves as they certainly have a lot to gain (or lose)?

Current buzz from DC is that the Obama transition team is looking to overhaul the FDA putting in a more aggressive leader.  Two candidates being considered are Steve Nissen of the Cleveland Clinic and Joshua Sharfsteir of the Baltimore Dept of Health. Both have been quite critical of pharmaceutical industry practices.

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