Misleading Drug Marketing Might Just Kill You

January 4th, 2013

Before heading to the drug store with a prescription your doctor just gave you to ease an ailment, you might want to take a few minutes to quiz your medical provider about whether the prescription is for an approved FDA use.

Why? Take the case of Amgen as a cautionary tale.

Amgen, the world’s largest biotechnology company, made billions marketing its anemia drug Aranesp for unapproved uses — uses that the FDA explicitly ruled off limits, and uses that subsequent studies showed increased a patient’s risk of blood clots, the worsening of cancer, and death.

In fact, a federal prosecutor told the court that, “in certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it.”

But these potentially deadly marketing tactics seem to have paid off for the company. While Amgen will be paying $762 million to put all this nasty business behind it, it can still claim many billions of dollars in sales from its illegal marketing scheme. The company pleaded guilty to a single misdemeanor count of drug misbranding, agreeing to pay $136 million in criminal fines, forfeiting $14 million, and spending about $612 million to settle civil litigation.

In July, 2012, in what was deemed as one of the largest settlements for health care fraud, GlaxoSmithKline paid $3 billion for, among other issues, promoting some of its drugs for unapproved uses. It was the fourth settlement the U.K.-based company made with the U.S. in recent years, which included payouts for marketing two antidepressants beyond their government sanctioned uses.

But the government may have a tougher time going after pharmaceutical companies in the future. A Second Circuit decision in December 2012 held that the First Amendment shielded a drug representation from prosecution for promoting the off-label use of a prescription drug.

With the Constitution protecting drug reps from touting off-label uses of medications and companies making profits on it — despite government fines — it’s probably worth patients’ time to question their physicians before popping prescribed pills.

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