Relative Efficacy and the "Me-Too" Patient

Huh? Jerry Avorn raises some interesting and valid arguments in his September 8th Perspective in the NEJM. But, unfortunately, he swiftly devolves into the bizarro world of Marcia Angell. In discussing FDA’s clinical measurements of “safe and effective” he posits that the public health would be better served if the agency also required, “consideration of a drugs efficacy and safety as compared with alternative therapies.” Dr. Avorn argues that such clinical evidence would make better prescribing information more readily available. But since every patient is unique, how relevant is this really? Just as there is no such thing as a “me-too” medicine (as any sober chemist will tell you), neither is there such a thing as a “me-too” patient. Patients (otherwise known as “people”) respond differently to different drugs — even drugs within the same therapeutic category. Asking FDA to recalibrate “safe and effective” to “as safe mostly but not as effective in some circumstances but somewhat more effective in others” is a poor public health course. Dr. Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital should know better. There are a lot of places that FDA belongs — but subjective intermediary between patient and doctor is not one of them.