Medicare spends more money on Amgen's Epogen than any other drug in its medicine chest -- $1.75 billion in 2005. Virtually all of it went to patients on dialysis. (The agency also pays for the same protein for cancer treatments, but those are sold under the brand names Aranesp by Amgen and Procrit by Johnson & Johnson.)
Given that level of spending, you'd think there would be pretty good evidence that this drug, which raises the red blood cell count, is delivering positive results for the unfortunates suffering from what the government and physicians euphamistically call "End Stage Renal Disease" (ESRD). The euphamism refers to the fact that the average life expectancy of a person who enters dialysis after their kidneys fail is about five years.
You'd think that but you'd be wrong. In fact, the evidence suggests just the opposite. Of course, treating the anemia associated with kidney failure was a godsend when Epogen first came on the market in 1987. It ended the need for blood transfusions, and allowed dialysis patients to have red blood cell counts (hematocrits) near normal.
However, the Food and Drug Administration's initial approval for Epogen called for raising hematocrits to about 15 percent below normal. While most patients don't notice the difference, Amgen, through a series of studies it funded, attempted to show that higher hematocrits were better for patients. Their measuring sticks? "More energy" and "greater alertness." Through intense lobbying, they used those studies to browbeat Medicare into reimbursing dialysis clinics to raise hematocrits to slightly below normal. Not surprisingly, in the wake of that 1997 decision, Medicare spending on Epogen soared.
But what were the medical results of that policy? In a paper published in 2004 in the Journal of Clinical Epidemiology, Dennis Cotter of the Medical Technology and Practice Patterns Institute and his colleagues at Johns Hopkins and the Boston VA showed that attempts to reach normal hematocrits, which required LOTS more Epogen, did not correlate with increased longevity for people on dialysis. In fact, they showed that raising ESRD patients' hematocrits to normal levels actually resulted in shorter lifespans because it increases the incidence of heart attacks, strokes and other cardiovascular events.
Gee. You mean thickening the blood in people who have severe microvascular distress from a lifetime of untreated hypertension and diabetes (which are the primary causes of kidney failure) causes heart attacks? To quote that famous line in Casablanca, I'm shocked.
Now, Cotter and colleagues are back in the latest issue of Health Affairs (subscription required), bringing us up to date on the Bush administration's policy on Medicare spending for Epogen. In a move that NO ONE in the mainstream press covered (Hey, another half billion dollars in drug spending? Who cares?), CMS this past April gave dialysis clinics the okay to raise patients' hematocrits to 39, which is normal for women and a shade under normal for men.
If Cotter's earlier paper is correct, the end result of this policy will be shorter lifespans for many dialysis patients, but greater sales and higher profits for Amgen. To use the dry language of the Health Affairs study, "CMS has tacitly implemented a policy that does not appear to confer additional proven benefit to its beneficiaries."
What would Cotter do about it? First, improve the evidence for drugs Medicare buys. Payment decisions should no longer be based on surrogate markers like the relationship between higher hematocrits and a subjective measure like "more energy."
Second, the agency should require randomized clinical trials, systematic reviews and meta-analyses to prove that a drug it pays for results in better outcomes for patients. In addition, since the companies selling the drugs have a stake in the outcome, those trials, reviews and analyses should be conducted by physicians without conflicts of interest.
Finally, if CMS doesn't have that kind of evidence generated in independent studies, it shouldn't pay for any drug that has not been prescribed for an FDA-approved use and at an FDA-recommended dosage.
This past week, Bernadine Healey, the former head of the National Institutes of Health, launched a wrong-headed attack against evidence-based medicine in U.S. News and World Report. (For a good blog entry attacking her article, see Gavin Yamey's latest posting on the PLoS Medicine website.) The Amgen-Epogen-dialysis saga is a perfect example of how ignoring the evidence is costing taxpayers a bundle.
Meanwhile, economic pundits like Robert Samuelson (see today's Washington Post) rail against increased Medicare spending (even though its costs are rising at a much lower rate than overall health care spending, a fact I wish he had mentioned in today's column).
But I agreed with his larger point, which is that uncontrolled health care spending (not just Medicare) will bankrupt the rest of the economy if left unchecked. But how should we rein it in? But cutting benefits and raising first-dollar coverage so people will simply stop going to the doctor for minor ailments and preventive care?
That would be a tragedy. What we need now are reporters in the mainstream media willing to go after companies like Amgen that rip off Medicare. Of course, we also need courageous editors willing to ignore the fact that the drug industry's full page ads are a major prop in their shrinking bottom lines.
But that's another story.