Sunday, December 30, 2012

Readers: Talking Up Off-Label Drugs Won’t Impact Practice

A plurality of MedPage Today readers said that classifying off-label drug promotion as free speech would not have any bearing on clinical practice.” Are there any competent clinicians out there who don’t or have never [prescribed] off-label? Would any willingly give up the right to do so? Then why should there not be the ability to interact regarding such use with those who represent the products?” asked one reader. Several readers noted that the very intelligence of physicians and their professional judgment is called into question if they can’t be trusted to listen with unbiased ears to pharmaceutical company representatives.
Several readers noted there is a difference between docs going off-label and pharma reps promoting off-label use. “When a doctor goes off-label, it’s most likely for the benefit of the patient. When pharma pushes off-label use, it’s for the benefit of the company pocketbook. Big difference. It’s hard to know what world that court panel is living in to call this free speech.”
Other problems detailed by those against sales reps having such “free speech” include more patients experiencing adverse side effects from drugs prescribed off-label. Nearly 9% of our readers said the court’s ruling will result in an increase in drug-related adverse events.nterestingly, shortly after the ruling, Wyeth, a subsidiary of Pfizer, agreed to pay $55 million plus interest to settle allegations it promoted off-label use of its acid reflux drug pantoprazole (Protonix).
Readers, however, sounded a jaded note to”record-breaking fines to pharmaceutical companies” because they are “actually dwarfed by the record-breaking profits made by promoting drugs for many uses.”
It might help, suggested a reader, if patients “sign releases that they realize it is an off-label use and that they accept the consequences of that.” But she added: “I’m sure a clever lawyer will try to sue us anyway.”

Source found here

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