Both wings of the government have been found in bed with Big Pharma, and now a new decision by the federal appeals court will make it even more difficult for them to mind the marketing and sales of pharmaceuticals. A conviction of a sales representative for promoting off-label use of a prescription drug was thrown out. Now it may be even easier for Big Pharma to sell drugs.
Off-Label Claims now Easier to Make
The 2nd US Circuit Court of Appeals overturned the 2008 conviction of sales representative Alfred Caronia of Orphan Medical Inc. Caronia had breached the Food, Drug & Cosmetic act by bringing a misbranded drug—Xyrem—into interstate commerce. In 2002, the FDA approved Xyrem for treating narcolepsy—a condition associated with weak muscles—and for excessive daytime sleepiness linked to nacolepsy in 2005. Just one month before the second FDA approval, however, Caronia promoted Xyrem for then off-label uses, including daytime sleepiness, muscle disorders, chronic pain, and fatigue. A trial by jury found him guilty and Caronia served 100 hours of community service in addition to a year of probation.
On Monday, however, he was cleared of conviction thanks to the First Amendment, which the 2nd Circuit agreed (albeit with some division) protected sales representatives to make “truthful” off-label claims about FDA-approved drugs. Caronia noted that doctors can do the same thing without penalty.
“Increases Marketability of Drugs”
Industry lobbyists like Matthew Bennett rejoiced, stating as vice president of Pharmaceutical Research and Manufacturers of America that the group was “pleased.”
Meanwhile, Caronia’s lawyer says (evocatively, perhaps), that the decision “increases the marketability of drugs.”
Drugs pushed by Big Pharma hardly need more marketing. (GlaxoSmithKline settled with the government for $3 billion in July over off-label claims, and Pfizer settled for $2.3 billion in 2009.) That a federal court made it easier for Big Pharma to make more money with science that goes against nature has numerous and far-reaching implications.
Government and Big Pharma vs. Nature?
Meanwhile, raw milk provider James Stewart can’t cut a break. His bail was set at $1 million—after the Centers for Disease Control and Prevention was finally forced to admit using misrepresenting statistics to link raw milk to death. (As we all know, however, stigmas die hard.)
Similarly, the FDA was only too happy to remove natural supplements like Pyridoxamine—a natural form of vitamin B6—from shelves at the behest of the pharmaceutical company BioStratum. Did the natural supplement have a defect? Nope. BioStratum just wanted to use Pyridoxamine in a prescription drug they’re going to develop in the future. The FDA is considering doing something similar for Medicure Pharma. (You can petition to quell some of this nonsense here.)