Amid all the hype about Avandia recently, a few relatively clear-cut observations are apparent (most of which are described better than I could hope to do in the July 5 issue of NEJM. Drazen et al, Dean, and Psaty each wrote wonderful editorials available at www.nejm.org).
1.) Avandia appears to have NO benefits besides the surrogate endpoint of improved glycemic control (and engorging the coffers of GSK, the manufacturer).
2.) Avandia may well increase the risk of CHF, MI, raise LDL cholesterol, cause weight gain and increase the risk of fractures (the latter in women).
3.) Numerous alternative agents exist, some of which improve primary outcomes (think UKPDS and metformin), and most of which appear to be safer.
So, what physician in his right mind would start a patient on Avandia (especially in light of #3)? And if you would not START a patient on Avandia, then you should STOP Avandia in patients who are already taking it.
To not do so would be to commit OMISSION BIAS - which refers to the tendency (in medicine and in life) to view the risks and/or consequences of doing nothing as superior to the risks and/or consequences of acting, even when the converse is true (i.e., the risks and/or consequences of acting are superior to those related to inaction). (For a reference, indulge me: Aberegg et al http://www.chestjournal.org/cgi/content/abstract/128/3/1497.)
This situation is reminiscent of recommendations relating to the overall (read "net") health benefits of ethanol consumption - physicians are told to not discourage moderate alcohol consumption in patients who already consume, but not to encourage it in those who currently abstain. Well, alcohol is either good for you, or it is not. And since it appears to be good for you, the recommendation on its consumption should not hinge one iota on an arbitrarily established status quo (whether for reasons completely unrelated to health a person currently drinks).
(For a reference, see Malinski et al: http://archinte.ama-assn.org/cgi/content/abstract/164/6/623; the last paragraph in the discussion could serve as an expose on omission bias.)
So, let me go out on a limb here: Nobody should be taking Avandia, and use of this medication should not resume until some study demonstrates a substantive benefit in a meaningful outcome which outweighs any risks associated with the drug. Until we do this, we are the victims of OMISSION BIAS (+/- status quo bias) and the profiteering conspiracy of GSK which is beautifully alluded to, along with a poignant description of the probably intentional shortcomings in the design and conduct of the RECORD trial here: Psaty and Furberg http://content.nejm.org/cgi/content/extract/356/24/2522.
This is discussion forum for physicians, researchers, and other healthcare professionals interested in the epistemology of medical knowledge, the limitations of the evidence, how clinical trials evidence is generated, disseminated, and incorporated into clinical practice, how the evidence should optimally be incorporated into practice, and what the value of the evidence is to science, individual patients, and society.
Sunday, August 5, 2007
AVANDIA and Omission Bias
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