Back in August I reported news that the large drug company, Amgen, planned to purchase Onyx Pharmaceuticals. This was big news for multiple myeloma patients; Onyx developed and distributes Kyprolis (carfilzomib), a newly FDA approved proteasome inhibitor.
Here are links back to my original posts:
At the end of the first I wrote:
This is a blockbuster announcement! I’m not a financial expert or advisor; I don’t think my minor in economics from the University of Wisconsin counts. I am aware that Amgen is facing a large number of sizable Medicare related fines and penalties. But that doesn’t seem to have slowed this deal down..
In response one of my readers, Susan, asked this:
What are the Medicare fines and penalties to which you were referring that Amgen is facing? Do you have a web site or article I can read? My brother works there and he thought it might have to do with reimbursements.
I wanted to follow-up about this. Here’s an excerpt from a New York Times article that ran December 18th last year:
The biotechnology giant marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.
The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.
Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.
David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.
Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.
The presiding judge, Sterling Johnson Jr., scheduled a hearing for Wednesday to announce whether he will accept the agreement. If he does, a broader settlement and as many as 11 whistle-blower lawsuits would be made public, some containing accusations beyond those to which Amgen pleaded guilty.
In court on Tuesday, prosecutors charged that Amgen had promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients receiving chemotherapy.
A subsequent study sponsored by Amgen showed that use of Aranesp by those nonchemotherapy cancer patients had actually increased the risk of death, and the off-label use diminished.
The federal charges also say Amgen promoted using larger but less frequent injection of Aranesp than stated in the label as a way of making the drug more attractive to doctors and patients than Procrit, a rival anemia drug from Johnson & Johnson…
Want to read more? Here’s the link to Andrew Pollack and Mosi Secret’s article, Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use:
Amgen specializes in a number of drugs used in dialysis patients, known as ESAs, or erythropoietin-stimulating agents, commonly used before and after dialysis.
Dialysis is one of the most politically involved parts of health care; dialysis clinics fall under a number of special Medicare and Social Security Disability laws.
The New York Times doesn’t seem to be a big fan of the company. Check-out this pair of scathing articles the newspaper ran about Amgen in January:
In the spirit of fair play, here was a response from Amgen officials at the time:
Honestly, I’m not sure where I’m going with this. None of this has much to do with multiple myeloma, except to help explain why Amgen may be trying to diversify and beef-up their oncology division.
I haven’t read anything about the pending sale the past few weeks. I will let you know if I hear anything new; it would be great if you could do the same.
I’m excited to announce that tomorrow I will be publishing the first of several posts I’ve been working on about the International Myeloma Foundation’s Black Swan initiative. IMF Medical Director, Dr. Brian Durie, was kind enough to answer a number of questions that readers asked me to pass-along shortly after the project was launched.
Feel good and keep smiling! Pat