US Court Lets Big Pharma Sail, Cracks Down on Natural Health
December 5th, 2012
Reader Views: 691
ByÂ Lisa Garber
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 2ndÂ 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 drugâ€”Xyremâ€”into interstate commerce. In 2002, the FDA approved Xyrem for treating narcolepsyâ€”a condition associated with weak musclesâ€”and for excessive daytime sleepinesslinkedÂ 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 2ndÂ Circuit agreed (albeit with some division) protected sales representatives to make â€śtruthfulâ€ť off-label claims about FDA-approved drugs. Caronia noted that doctors can do the same thing without penalty.
â€śIncreases Marketability of Drugsâ€ť
Industry lobbyists like Matthew Bennett rejoiced, stating as vice president of Pharmaceutical Research and Manufacturers of America that the group was â€śpleased.â€ť
Meanwhile, Caroniaâ€™s lawyer says (evocatively, perhaps), that the decision â€śincreases the marketability of drugs.â€ť
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 withÂ science that goes against natureÂ has numerous and far-reaching implications.
Government and Big Pharma vs. Nature?
Meanwhile,Â raw milkÂ provider James Stewart canâ€™t cut a break. His bail was set at $1 millionâ€”after the Centers for Disease Control and Prevention was finallyÂ forced to admitÂ using misrepresenting statistics to link raw milk to death. (As we all know, however, stigmas die hard.)
Similarly, the FDA was only too happy toÂ remove natural supplementsÂ like Pyridoxamineâ€”a natural form of vitamin B6â€”from shelves at the behest of the pharmaceutical company BioStratum. Did the natural supplement have a defect? Nope.Â BioStratum just wanted to use Pyridoxamine in a prescription drug theyâ€™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 nonsenseÂ here.)
This post originally appeared onÂ Natural Society
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