April 18, 2007

Overdosing for Dollars

I walked into a dialysis clinic for the first time about a decade ago. It was in Baltimore, and it was an inner-city non-profit clinic run by a kindly, white-haired gentleman named Dr. Sandler. I learned a lot about medicine and the financial inducements that lead doctors astray from him, and for that I will always be grateful.

I raise that this morning because Dennis Cotter and his colleagues at the Medical Technology and Practice Patterns Institute have a new study out in the Journal of the American Medical Association showing that for-profit dialysis clinics use up to three times more anti-anemia drugs than non-profit clinics with comparable patient populations. Amgen's Epogen is the sole approved product for the anemia that accompanies kidney failure (Epogen is the genetically engineered version of the protein produced by the kidneys that stimulates red blood cell production), and dialysis clinics make a hefty mark-up on the wholesale price of the drug.

Dr. Sandler said two things that day that have always stuck in my mind. He worried that too much Epo use might harm his patients, so he rarely dosed them over the FDA label. (The FDA last month slapped a black box warning on Epogen, Procrit and Aranesp -- the latter two are used for cancer -- because using too much of the drug causes heart attacks and early death, according to recent studies).

And the nephrologist also said that to understand the "guidelines" for Epogen's use that had been written by his professional peers, you had to look at who was behind those guidelines. Last week, the National Kidney Foundation's panel of renal docs issued proposed new anemia guidelines that ignored the FDA warning. Two-thirds of the physicians on the panel had financial ties to Amgen.

Today's Wall Street Journal quotes Rep. Pete Stark (D-CA). He wants to eliminate the financial incentives that encourage overuse of Epogen, which is harming patients. I also spent a lot of time talking to Stark's aide in those days, Bill Vaughan, who now plies his trade at Consumers Union. Stark's office was saying the same thing back then.

When will the Center for Medicare and Medicaid Services (the taxpayers pick up the tab for most dialysis patients in America) change its policy and eliminate payments for the excessive and dangerous overuse of this drug?

Posted by gooznews at April 18, 2007 06:24 AM
Comments

Mr. Goozner,

I would highly recommend that you re-visit a dialysis center before making such claims. I would also recommend that you spaek to a patient with a hemoglobin of 11 and ask them how GREAT they feel. Better yet, maybe you could allow yourself to be bled out approximately 25% of your current blood volume and see how much energy you have. None of the people making these claims have even spoken with a dialysis patient to get their point of view. May be a good place to start!

Posted by: Brad Edwards at April 20, 2007 02:45 PM

The question is: what are the comparable outcome measures between the for-profit and non-prof clinics? I take your point that too much Epo is bad, but if the JAMA piece doesn't give us outcomes, it's hard to evaluate the study.

Posted by: Jared Bernstein at April 24, 2007 08:53 AM

Merrill's point isn't to say giving dialysis patient anemia drugs is bad or should be banned. It's that the standards for how drug is enough, and what the target hemoglobin level should be, are being set by people with conflicts of interest with the manufacturers. We've seen time and again how these standards wind up being biased by conflict of interest in favor of the drug maker. If I were a patient, I think I'd like to know that I'm being given a drug on the basis of good science. There's reason to doubt that's the case with these new dialysis standards.

Posted by: Shannon Brownlee at April 24, 2007 10:47 AM

In fact, my initial visits and interviews involved people who were dosed EPO to arrive at hemoglobins between 10 and 11, the original FDA labeling on the drug. Some were sick and felt tired; some were relatively healthy and felt fully energized. My takeaway conclusion then and still is that it is how well the underlying illnesses that caused kidney failure in the first place are being treated (is the hypertension now under control? Is the diabetes now under control?) that determines how well patients feel -- not their red blood cell count.

re Jared's question: good point. The study author, Dennis Cotter, has data on that point, but it wasn't the point of this particular study. Other studies have shown that the sickest patients on dialysis (those whose underlying conditions are worsening because they are not taking care of their hypertension, diabetes, etc.) get the highest doses of Epo. So in fact, higher dosing correlates with worse outcomes overall.

And thanks Shannon for echoing my major point. Let's let physicians without ties to Amgen or J&J write these guidelines. The first question for advocates of "evidence-based medicine" always should be: who wrote the evidence?

Posted by: Merrill at April 24, 2007 01:36 PM