Showing posts with label Despite Critics Dismissal - Off Label Prescribing May Benefit Patients. Show all posts
Showing posts with label Despite Critics Dismissal - Off Label Prescribing May Benefit Patients. Show all posts

Thursday, October 10, 2013

Despite Critics Dismissal - Off Label Prescribing May Benefit Patients


Over the past several years, the federal government and law enforcement agencies have increasingly investigated and prosecuted large pharmaceutical and medical device companies for off-label marketing. Various media outlets have covered these settlements and cases and others have even conducted their own investigations (e.g., ProPublica.
Consequently, a recent article from the Pacific Standard, written by Ford Vox, a rehabilitation physician at Shepherd Center, addressed an investigation conducted by The Washington Post that looked into off-label prescribing. Vox, who treats survivors of acquired brain injury and spinal cord injuries, noted that the kind of reporting conducted by the post will create "chilling implications for the practice of medicine in difficult populations."
Background
In May 2013, in cooperation with the investigative journalism non-profit ProPublicaThe Washington Post published a high-profile expose into physicians' prescribing habits. The article highlighted that, although the Centers for Medicare and Medicaid Services (CMS) should know the prescribing trends of its participating physicians, the agency has not used the trove of data at its fingertips to police member prescribers.
Vox noted that "Two questionable assumptions drove the reporting by The Washington Post: (1) Medicare has the mandate to police physicians practicing legally and in their normal scope; and (2) there is something inherently suspect or dangerous about off-label prescribing. To back up the piece's implication that off-label prescribing carries unusual obligations, reporters turned to bioethicist Alexander Capron who advised, "when one moves beyond a single patient or maybe a couple of patients … you're basically saying, 'I'm doing a study.'"
Why Off-Label Prescribing Benefits Patients
As a physician tasked with managing the care of patients suffering from the effects of acquired brain injuries, Vox asserted that he cares "a lot about off-label prescribing." Vox said he prescribes "off-label every working day."
He maintained that "Medicine does not always have the luxury of waiting until the mountains of needed research on any given problem are completed centuries from now. [Doctors] are tasked with treating real-world suffering today."
Consequently, he challenged Capron on his belief that off-label prescribing is improper. Vox explained that "Capron believes that a physician who has found an off-label use of a medication to be helpful for a particular problem in a particular population has an ethical obligation to publish a research article reporting the findings to the world. He has even given a threshold outlining when the practice of medicine ends versus when the practice of unethical, non-institutional review board approved research begins."
- See more at: http://www.policymed.com/2013/10/despite-critics-dismissal-off-label-prescribing-may-benefit-patients.html#sthash.fZzJbWTs.dpuf