Monday, December 05, 2005

Might some good come from the drug-trial book cooking of big pharma?

What good could possibly be derived from publishing misleading medical information in main line journals?
I'll admit this may be carrying the half-full half-empty glass thing a bit too far. But here goes. We-the medical professionals-are now on notice that when we read about a RCT or doze through a meta-analysis that we have to be much more critical and skeptical that ever before. We should now more than ever know better than to say that because there was a RCT showing that drug x did whatever good thing that we now should use that drug and now we have evidence based medicine behind our decision. An RCT may be the best tool we have to assess drug and procedure efficacy and give some data regarding safety but one or even two RCTs are not necessarily sufficient to wrap the banner of EBM about the decision to use that medication.RCT design can be structured to give positive results that are in fact bogus. For example,you can compare your new drug with a lower than maximally effective dose of a old drug and there are many other more subtle tricks of the trade that we can now detect thanks to the growing recognition of the sometimes duplicitous behavior of drug companies. Big Pharma's antics have made us better consumers of medical information and more able to recognize the various forms that pharmaceutical infomercials (I 'm taking about free dinner talks and some of the material in the throwaways) now take. Importantly, medical journal editors are taking steps to make more transparent the mechanics of how clinical trials are put together and analyzed and requiring the authors to make more meaningful statements regarding their role in the publication.Academic centers are beginning to access FDA data and independently re-analyze date regarding drug safety and efficacy.(Kudos to the folks at Cleveland Clinic for leading the way in that regard).Lastly, although hyper-rapacious and overreaching plaintiff attorneys have earned their less than overwhelmingly positive reputations with physicians and the general public, the VIOXX trials may well not only inform us about how drug companies may place short term profits above all else but will serve as a major wake up call to the drug industry that that the jig is up in regard to misleading the medical profession and the public about their products.
We have learned that RCTs are vulnerable to manipulation and- because of that and the fact that typically the subjects chosen for the trials are not always enough like the patients we treat-as important a tool as they can be, they need to be classified as more as a silver standard than a gold standard. Knowing that a given finding resulted from a RCT should not end the discussion, that fact should be the beginning of a consideration of the details of the trial and analysis wherein sometimes the devils lie.Our recognition of some of the ways Big Pharma has manipulated certain aspects of evidence based medicine may have served to alert and inform us about the limitations of EBM.

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