Monday, November 7, 2011

GoozNews on Guideline/FDA Panels: Yes, There Are Non-Conflicted Experts

I've commented previously on the canard that the FDA must fill their advisory panels with docs paid by the drug industry, as those guys are the only real experts:
http://brodyhooked.blogspot.com/2011/08/nih-conflict-of-interest-rules-weakened.html

Our esteemed colleague Merrill Goozner addressed this head-on (in relation to recent discussions of NIH guideline panels) in his GoozNews blog--
http://gooznews.com/?p=3319

Let me turn the mike over to him:

That [you need to accept industry-funded people or else do without the real experts] is simply not true. When the Food and Drug Administration commissioned a study to see if it couldn’t make up its advisory panels with conflict-free experts, the outside consulting firm discovered that it would take about one week to find unconflicted physicians with the skills required to analyze clinical trial and other data needed to serve. Moreover, based on the publication records of the people turned up by such a process, the unconflicted physicians would have been more highly qualified than the “thought leaders” on drug or other industry payrolls who actually got the jobs.

Gooz identifies the critical point. In "opinion leader" circles it is simply assumed that "expert" means somebody who sits at a lab bench and discovers a new molecule, or else somebody who designs and runs clinical trials. These folks are no doubt commendable and knowledgeable, but they're not the people with the skills you most need when it comes to serving on an FDA advisory committee or writing clinical guidelines. Those tasks need different experts, people with training in fields like biostatistics and clinical epidemiology, who know how to sort through and weigh evidence from various sources. So sadly, when a mucky-muck at FDA or NIH says they need to include people with conflicts because they're the experts, they're not merely defending a flawed status quo; they're admitting that they don't understand what the real task at hand is.

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