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Warning didn't change for-profit dialysis drug use

By Andrew M. Seaman

NEW YORK (Reuters Health) - Despite a strong warning from U.S. regulators in 2007, for-profit dialysis centers still gave their kidney failure patients more of a certain anemia drug than non-profit centers in 2008, says a new study.

The researchers write in JAMA Internal Medicine that their finding suggests for-profit dialysis centers may have been motivated to give more of the drug for financial gain in spite of the warning.

For example, the more of the drug the centers used, the more they'd get paid.

"Our study can't say for sure that higher uses of these agents were caused by financial profitability for these providers, but it suggests it's a possibility," said Dr. Julie Ishida, the study's lead author from the University of California, San Francisco.

Erythropoiesis-stimulating agents - or ESAs - are given to most people with chronic kidney failure to treat anemia by producing red blood cells. Anemia can cause people to look pale, feel tired or sluggish and short of breath.

The researchers looked at epoetin alfa, which is marketed as Epogen by Amgen, and darbepoetin alfa, which is marketed as Aranesp also by Amgen.

In 2007, the U.S. Food and Drug Administration (FDA) issued a black box warning - the strongest kind - to use as little of the ESAs as possible. Research showed higher doses were associated with an increased risk of death, strokes and heart disease.

"It's a great drug. It's just that it does have side effects and people do need to be aware of them," said Dr. Nina Tolkoff-Rubin, director of renal transplantation and hemodialysis at Massachusetts General Hospital in Boston.

Previous studies had found that for-profit dialysis centers gave more ESAs than non-profit centers, and Ishida and her colleagues wanted to see if that changed after the FDA issued its warning.

For the new study, the researchers used a database of 275,291 people who were receiving dialysis before the warning was issued in February 2007 and after it was in place in February 2008. All patients were on Medicare, the U.S. insurance program for the elderly and disabled.

Overall, both for- and non-profit dialysis centers reduced their use of ESAs between 2007 and 2008, but for-profit centers still gave their patients significantly more of the drugs than their non-profit counterparts.

In 2007, for-profit dialysis centers - on average - gave their patients about 9,000 units per weekly dose, compared to about 8,300 units per weekly dose in 2008.

Non-profit dialysis centers gave their patient an average of 5,600 units per weekly dose in 2007, compared to about 5,000 units per weekly dose in 2008.

"Even in people who switched from non-profit to for-profit facilities, we saw their levels went up. Conversely, when they switch from a for-profit to non-profit, their level of the drug went down," Ishida said.

She noted that they could not compare the outcomes of patients at the various types of centers.

NEW PAYMENT SYSTEM

Tolkoff-Rubin, who was not involved with the new study, said the findings made sense, but she doesn't think the researchers would find the same results if they did their study today.

That's because the Centers for Medicare and Medicaid Services implemented a so-called bundle payment system for dialysis services in 2011. That means dialysis centers receive one payment for all dialysis care - no matter how much ESA is used.

"I'm sure if you looked at it now, it wouldn't look this way. What you're seeing is a snapshot from when there was an incentive to give more," she said.

Ishida said she plans to do a similar study looking at what happened after the bundled payments were put in place.

"In this era of changing reimbursement for end-stage renal disease, I think it will be important for patients and doctors to be aware of the possible influences on treatment decisions," she said.

(This story is refiled to clarify paragraph 6 with the names of the specific drugs used in this study)

SOURCE: http://bit.ly/12bwyGm JAMA Internal Medicine, online May 13, 2013.

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