The Trials of Amgen

Yes, Virginia, there can be too much of a good thing.

The New England Journal of Medicine on Thursday reports that dialysis patients given high doses of Amgen's best-selling drug Epogen (or Aranesp) wind up having more heart attacks and strokes than their counterparts on lower doses. Finally, after two decades of goofy Amgen "quality of life" studies, the arbiter of medical knowledge in the U.S. finally reports what everyone who paid close attention to what was going on in this field knew for years: Amgen was killing people by lobbying Medicare to overuse and overpay for its drug.

I have written this story so many times over the past few years that I barely have the energy tonight to recapitulate the details. Suffice it to say that people with failing kidneys need recombinant erythropoietin (Epogen, Aranesp, Procrit . . . it's all the same thing) to maintain their red blood cell count. The FDA in the late 1980s approved the drug for raising the level to about 85 percent of normal. Amgen, by funding studies showing higher red blood cell counts lead to "more energy," was able to convince Medicare (intense lobbying on Capitol Hill didn't hurt) that it should reimburse to near normal levels.

Now the results are in (actually, this has been reported for years in "lesser" journals): if people whose kidneys (which are basically a bundle of tiny blood vessels for filtering waste from blood) failed because they had untreated hypertension or poorly treated diabetes for long periods of their adult lives have their red blood cell count raised to normal levels, they have more heart attacks and strokes and die faster than people with slightly thinner blood. In other words, people with severe microvascular distress don't do too well with thicker blood. It took two decades to figure this out?

Now let's see how many years it takes for Medicare to dial back its reimbursement level to fit the evidence. On the one hand we have dead people and serving our corporate masters; on the other hand we have living people and saving the taxpayers money. How hard a decision is that?

Here's the public health math: The government spends over $2 billion a year for this drug. If even 25 percent of it is wasted (don't forget, correcting for the original anemia to a modest level makes sense), think of how many public health nurses that could hire in low income communities. I'll do the math for you. That's 8,000 jobs at $62,500 a year. Their job? Fan out across the country to identify and then teach people with untreated hypertension and poorly controlled diabetes how to control their conditions so that they don't wind up on dialysis.

Now that would be cost-effective medicine. Alas, it's called preventive health care and we don't do that in America.

One last point: I can't wait to see if Amgen attacks these studies because of their authors. Both studies were funded by Amgen's competitors: Johnson & Johnson's Orthobiotech division and Hoffmann-La Roche. They're mad because Amgen has been using Aranesp, a longer-acting version of Epogen, to horn in on their territory, which is the cancer market.

But that's another long, sad story. If you want details, read chapter one of my book, which is available for free on line at one of the on-line book retailers.

Posted by gooznews at November 15, 2006 10:42 PM