Healthy Skepticism Library item: 8728

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Hampton T.
Experts weigh in on promotion, prescription of off-label drugs.
JAMA 2007 Feb 21; 297:(7):683-4
http://jama.ama-assn.org/cgi/content/full/297/7/683

Abstract:

Off-label drug use has been around for decades, and it is perfectly legal for physicians to prescribe a medication for a condition not described in the approved labeling if it seems reasonable or appropriate.

Determining the appropriateness of such prescribing can be difficult, however, as physicians are drowning in reports from laboratory studies and clinical trials, potentially dubious promotions from pharmaceutical companies, pressure from patient advocacy groups to provide more therapies for various conditions, and hurdles to reimbursement by insurance providers. Experts suggest that changes in regulations and reimbursement relating to off-label therapies may be needed to help physicians give each patient the best care possible in today’s clinical environment.

APPROPRIATE PRESCRIBING
According to the US Food and Drug Administration (FDA), when prescribing a . . .

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909