GlaxoSmithKline paid $3 billion.
Abbott Laboratories paid $1.4 billion.
Pfizer paid $2.3 billion.
Eli Lilly paid $1.4 billion.
And now, Amgen will pay $762 million for, as a U.S. attorney in New York said last month, “pursuing profits at the risk of patient safety.”
Yes, folks, once again a major player in the pharmaceutical industry has been caught engaging in criminal behavior, thanks in part to a former employee who couldn’t tolerate its utter disregard for the law, and blew the whistle.
We regularly cover the misdeeds of Big Pharma (here, here and here), and everyone aware of this history of settlement payments understands that to the drug industry, they’re merely the cost of doing business.
The Amgen settlement, as reported by the New York Times, resulted from federal charges to which Amgen pleaded guilty. The company illegally marketed Aranesp, which is approved by the FDA for chemotherapy patients. But that wasn’t enough for Amgen, who promoted it to treat anemia in cancer patients. That’s an “off-label” use, or one for which the medicine was not approved.
Amgen also was charged with promoting larger doses of Aranesp than the label directed. That enabled the drug to be used less frequently, which, according to The Times, made it more attractive to doctors and patients than a rival’s anemia drug.
Doctors are allowed to use drugs for off-label use, but companies may not promote them.
Clearly, Glaxo, Abbott, Pfizer, Lilly, Amgen and who knows how many others don’t care. These companies believe the rules were written for everyone but them. Amgen had tried to obtain FDA approval for the less frequent dose, but was denied. The FDA called the company’s studies inadequate. So what? was Amgen’s response–according to federal charges, the company continued to promote the off-label dosing after the denial.
One federal prosecutor told a judge, The Times reports, 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.”
Sales representatives, according to The Times, were not supposed to initiate discussions of off-label uses, but they were trained in ways that would prompt doctors to ask certain questions that opened the door for the reps to offer the docs “studies” supporting the off-label use. Amgen calls this approach “reactive” marketing. Federal prosecutors called it illegal.
A story in the Los Angeles Times recounted how one former Aranesp product manager filed suit against Amgen, alleging that, among other inducements to use the product, it gave “liquid kickbacks” to doctors. She charged that Amgen overfilled vials of Aranesp so doctors got more medicine without paying the additional cost. She said the company encouraged the docs to bill Medicare and private insurers for the surplus, thereby scamming the system and lining their pockets.
Why does Big Pharma continue to get away with criminal behavior? Because the fines, as huge as they are, don’t begin to threaten the companies’ huge profits-at one point, Aranesp earned Amgen more than $4 billion a year. Critics, according to the New York Times, say that the companies won’t be deterred until their executives are held personally responsible.
The U.S. attorney said that there was insufficient evidence to charge individuals at Amgen. But the company did agree to sign a corporate integrity agreement requiring execs and board members to personally certify compliance with regulations, which would make it easier to prosecute individuals if the company violated the law again.
Not that it’s suitable redress for Amgen’s despicable behavior, but Aranesp, which once was Amgen’s biggest seller, has declined in popularity. Studies, the New York Times says, show that high doses can lead to blood clots and the worsening of cancer. Sales of Aranesp in the first nine months of 2012 were $1.55 billion.