Higher Levels Of Popular Anemia Drugs May Increase Risk Of Heart Problems And Death
The most recent discussion about safety issues surrounding the anemia drug epoetin — sold by Amgen as Epogen, sold by Johnson & Johnson (J&J) as Procrit — started with a November 8, 2006 article in the Boston Globe by Christopher Rowland. He reported on the results of a study that was soon to be published in The New England Journal of Medicine as follows:
[Dr. Ajay Singh, clinical chief of the renal division at Brigham and Women’s Hospital in Boston,] whose clinical trial linked aggressive use of anemia drugs to an increased risk of fatal heart attacks and strokes says the government is not doing enough to protect dialysis patients from the potential dangers.
… The trial, called CHOIR , was halted last year because patients whose red blood cell counts were boosted the most died at an unexpectedly high rate.
… In anticipation of the CHOIR study’s publication, physicians and policy specialists are debating a basic question: How much Epogen is too much? Even though the drug is widely used to manage anemia in all kidney patients — not just the 325,000 on regular dialysis — as well as in cancer patients undergoing chemotherapy, definitive studies on its effectiveness and safety thresholds have not been performed.
Singh said the FDA should require Amgen and other manufacturers of the drugs — synthetic hormones which stimulate red blood cell production in bone marrow — to sponsor studies to establish a threshold for anemia treatment.
This was followed by a November 16, 2006 article called "Heart Risk Seen in Drug for Anemia", in The New York Times by Alex Berenson, from which we learn:
A medical study to be released today suggests that high doses of a best-selling drug used to treat anemia in dialysis and cancer patients may increase the risk of heart problems and deaths.
… The findings reinforce mounting concerns that kidney patients may be receiving too much epoetin, in part because dialysis clinics make bigger profits for providing larger doses. Studies show that the clinics make little, if any, profit on the actual dialysis services they provide for Medicare patients, who are the vast majority of patients.
The amount of epoetin received by the typical American dialysis patient has nearly tripled since the early 1990s….
But the studies show that the anemia of many patients is being overcorrected and that doctors should aim for lower levels of red blood cells in their patients, he said. The simplest way to do that would be to give patients less epoetin.
Indeed, the solution proposed by Dr. Singh seems sensible and simple enough to implement. Why, then, is there resistance from Amgen to this solution?
For that we turn to Merrill Goozner, who spent more than 25 years as a reporter for the Chicago Tribune and other publications. In a November 20, 2006 email about his online newsletter, This Week in GoozNews, Mr. Goozner gives us some insight.
Nearly a decade ago, I was an economics reporter who stumbled onto the drug industry by attending hearings on Capitol Hill about the fate of Medicare. I eventually wrote a piece for the Chicago Tribune headlined "The Making of a Star Drug," where I documented the games played by Amgen around its best-selling drug Epogen, then as now the drug that Medicare spends more money on than any other. That story eventually became the first chapter of my book, "The $800 Million Pill." Epogen was back in the news last week. A new study appearing in the New England Journal of Medicine pointed what observers like myself have been arguing for years. The high doses of Amgen’s pricey drug may be killing people on dialysis. Naturally, my posts last week focused on this issue. Read them and weep for the poor people on dialysis who have been victimized by this company.
Here are two recent articles by Mr. Goozner about this ongoing problem with epoetin:
- Amgen, NKF and the Dialysis Killing Fields (November 17, 2006)
- The Trials of Amgen (November 15, 2006)
Hopefully this renewed discussion about what levels of Epogen and Procrit are safe for use in patients with anemia will produce some results this time around.
(Posted by: Tom Lamb)
Leave a Reply to Tom Lamb Cancel reply