Monday, December 24, 2012

Yet Another Silly "Integrity"" Agreement: Amgen and Aranesp

Okay, now we can go back to the standard form:

Company: Amgen
Drug: Aranesp (darepoetin alfa)
Offense: Marketing drug for off-label uses (anemia in all cancer patients when approval only for patients receiving chemotherapy)
Amount of settlement: $762M (including both criminal and civil penalties)
Settlement is what percentage of annual revenues from drug sales: 38%
Did company admit wrongdoing: Yes, pleaded guilty to one misdemeanor account

The facts are summarized in the usual insightful post by Dr. Roy Poses at Health Care Renewal:
--which in turn cites the New York Times:

All this is same song, third verse for readers of this blog who might remember these previous two posts:
--on which more in a minute. Basically, drugs to treat anemia in both cancer patients and kidney dialysis patients have been pushed heavily by drug companies, despite evidence (that was successfully hidden for some years) that higher doses of these meds, leading to higher blood counts, actually caused more patient deaths by leading to blood clotting. Aranesp is one of this family of drugs (generally referred to as epoetins). While as a technicality Amgen was nailed on off label marketing for claiming that all cancer patients, and not just those on chemotherapy, needed their red blood cells boosted up with this medication, the real offense was aggressively pushing the drug despite risks of harm.

Now, as the older of the two previous posts made clear, the blame for this sad state of affairs only partially lies with the drug firm, though they clearly did everything they could to milk extra profits even over the bodies of dead patients. The other part of the puzzle is the crazy way the Feds have reimbursed kidney dialysis and cancer docs. They are virtually the only physicians paid on commission for prescribing either more expensive drugs, or higher doses of drugs. So when Amgen came to these docs and said, your patients have this terrible anemia, use our expensive drug to boost their red cell count, and don't worry about those nasty rumors about lack of safety when you use the highest possible doses, they were preaching to the choir, as these docs pocketed extra money both for using the drug in the first place and also for using more of it. As I said in the original post, how anyone could be so insane as to imagine that such a system would result in high-quality patient care truly amazes me, and I'm pretty much beyond being amazed.

As is his constant refrain, Dr. Poses notes that no one at Amgen is doing any jail time, or even is worried about it, after the company pleaded guilty to criminal charges. When the drug, even now that docs have finally been warned and are using less of it, sells $2B worth every year, the company can easily afford a $700M settlement. In the face of these business realities--just pay your fine and go your merry way, and no company executive will ever suffer personally--then the fact that Amgen signed a "corporate integrity agreement" as part of the settlement remains nothing but a really bad joke. It was only as short time ago that we (thanks again to Dr. Poses) noted the repeat offenses of another company that has now signed enough corporate integrity agreements to paper the CEO's suite:

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