Food and Drug Administration Urges Less Use of Anemia Drugs

¶ WASHINGTON — Federal drug regulators said on Friday that three drugs that had been widely used to treat anemia in both kidney and cancer patients were so dangerous to the heart that doctors should consider avoiding the medicines altogether in some patients and using less of them in others.
Erik Jacobs for The New York Times

Epogen is a erythropoietin-stimulating drug used by kidney and cancer patients suffering from anemia.

¶ The Food and Drug Administration concluded that there were no risk-free doses of Epogen, Aranesp and Procrit, and that doctors should use the medicines only in patients suffering from severe anemia. Doctors have used the medicines in the past to make patients feel better and as a way to increase chemotherapy doses in cancer patients.

¶ But there is growing evidence that the drugs may have cost many patients their lives by causing deadly strokes and other heart problems, as well as speeding the growth of cancer tumors.

¶ “This is a very big deal,” said Dr. Jay Wish, a professor of medicine at Case Western Reserve University in Cleveland. “It’s going to hit the dialysis population right now in a big way.”

¶ The medicines have cost the federal government more than $60 billion since they were introduced in 1989, and for years they were the biggest single drug expense in the federal Medicare program. The medicines have been big money makers for oncologists — who earn a mark-up for many of the medicines they prescribe — as well as dialysis providers.

¶ But as Congress debates ways of saving money in the Medicare program, some critics have pointed to these medicines — known collectively as erythropoietin-stimulating agents — as examples of how poorly the federal government controls expenses in the program. The United States is among only a few industrialized countries that do not routinely assess whether new drugs or devices are worth providing to patients whose care is paid for by the government. Those decisions are largely left up to doctors, many of whom have financial incentives to use the drugs or devices. Indeed, doctors in the United States used far more Epogen, Aranesp and Procrit than doctors in Europe and elsewhere who did not profit from their use.

¶ “Sixty billion dollars have gone out the window on these drugs, and what do we have to show for it?” asked Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit health policy research institute in Bethesda, Md. Citing government estimates that as much as $800 billion in health care expenses may be wasted annually, Mr. Cotter said, “It’s time we had a sound way of assessing the value of these technologies.”

¶ Amgen, a large biotechnology company, was built on the sales of Epogen and Aranesp. Johnson & Johnson sells Procrit, which is manufactured by Amgen. Dr. Roger M. Perlmutter, executive vice president for research at Amgen, said the company supported the new F.D.A. warnings, which will be placed on the labels that educate doctors.

¶ “The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis,” Dr. Perlmutter said.

¶ Epogen, Aranesp and Procrit work by spurring the body’s production of red blood cells, which ferry oxygen to the body’s tissues. Professional athletes, particularly cyclists, have used the drugs (often improperly) to improve performance. They were developed to help dialysis patients cut down on blood transfusions, but Amgen and Johnson & Johnson soon persuaded doctors that the drugs helped both kidney and cancer patients feel better even when not suffering severe anemia. The consulting payments that the companies made to top doctors, including those who wrote guidelines for the drugs’ uses, may have played an important role in doctors’ enthusiasm.

¶ The drugs are expensive, and that means they have been particularly profitable for oncologists and nephrologists. But sales have been falling since 2007, when studies renewed concerns that the drugs might cause heart attacks and strokes and spur the growth of cancer.

¶ Friday’s warning about the drug’s risks is the most severe yet and will likely reduce uses of the drugs in kidney patients by as much as a third, Dr. Wish said.

¶ “I think it’s fairly draconian and is an overreaction,” said Dr. Wish, who has consulted for makers of the drugs. “They’re scaring everyone away.”

¶ Dr. Daniel Coyne, a professor of medicine at Washington University in St. Louis, asked why any patient would willingly risk a fatal stroke or heart attack just to reduce the number of blood transfusions they might require while on dialysis. He said he would probably cut the dose of the medicine he provided to dialysis patients by a third or more and eliminate it from the care of many patients not yet on dialysis. He and other nephrologists predicted that the F.D.A. warning would change the way Medicare paid for the drug.

¶ “This is a shockingly bold statement by the F.D.A., but is firmly evidence-based,” Dr. Coyne said.

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