May 15, 2010

Forbes Tackles the Off-Label Question

A great article just published in Forbes highlights an often neglected topic; that "off label" usage of medications can lead to good outcomes. The authors correctly state that "off label" accounts for about 20% of all prescription writing and in some cases up to 50% as in cancer and cardiology. There are many cancer diseases where there is no "on label" option. For many patients not having on label options will mean no treatment. There is description of how malpractice can result if the standard of care includes "off label" use and a patient is not treated with such drug.  Medicare allows for off label use and reimburses for that. Yet it is ironic that the off label aspect if often cited by industry critics as one of the key evil practices. So much so that the largest monetary settlements have occurred often associated with "off label" promotion. If the purist would insist that all CME communications be limited to on label that would be highly limited, destructive and infringing on First Amendment.   CME events will become robotic interactions that will defeat their own purpose. This is what we see now in the case of drug reps who have to stay on label. Their value goes down if they have limited freedom speech. Freedom must prevail.

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