There's an interesting article in SFGate today about why docs prescribe drugs off-label. Since CME is one of the few places off-label use can be talked about, I thought this particular section was noteworthy:
Defenders of off-label use see it as a form of "innovative medicine'' that may make therapeutic advances available to patients when an FDA review isn't available. Doctors rely on research studies, their own observations and the shared experiences of colleagues.
"Probably the most important thing takes place at meetings, in the hallways,'' said Dr. Michael Franzblau, a clinical professor of dermatology at UCSF. "Doctors ask each other, 'What do you do for this?' ''
The publication of research studies can also start a chain of events by which some drugs come into widespread off-label use, even if the data are never submitted to the FDA. Such studies, whose quality can vary widely, are cited in practice guidelines written by medical experts, and included in drug compendia that health plans consult when deciding what medicines they'll pay for.
Wary observers such as Harvard's Avorn, however, say all these routes from the drug factory to the prescription pad are much too vulnerable to manipulation by pharmaceutical firms. Avorn said doctors are markedly influenced by drug company salespeople who provide free dinners, free samples and questionable information. Doctors sometimes rely on substandard studies that they're ill-prepared to assess, he said.
Physicians at medical meetings may not realize that a fellow practitioner vouching for an off-label use has been hired by the drugmaker to give the presentation. The FDA forbids drug firms to plug off-label uses, but industry watchers say the practice has been rampant at some companies.
