Aug 19, 2009 0
Information Gaps: Drug Labels and Medical Decisionmaking
Last week, a research team from Stanford University School of Medicine and the Veterans Affairs Palo Alto Health Care System published an essay in the New England Journal of Medicine suggesting that new drugs be labeled not only with what we know about them (which they now are), but also with an accounting of what we don’t know.
The Stanford researchers’ effort to clarify the ambiguity surrounding the comparative effectiveness of recently approved drugs is laudable. But their proposal that the FDA begin labeling drugs with measures of this comparative effectiveness both ignores the realities of how pharmaceutical innovation happens today and endorses a flawed decisionmaking model that could foster false security in patients and undermine their medical caregivers—the professionals who are trained to help each particular patient discriminate among drugs of the same class in a way a label cannot. Doctors can and do disagree about what constitutes a statistically significant difference between two drugs. Giving patients a nudge in the direction of involving themselves in that decision—and the confidence to do so—without properly equipping them to make informed decisions will diminish rather than improve the overall quality of patient care.



