For-Profit Dialysis Centers May Have Ignored Anemia Drug Warnings: Study

Even after the FDA warned that anemia drugs like Aranesp, Epogen and Procrit could increase the risk of death among patients, for-profit dialysis centers continued to use them more than non-profit centers, according to the findings of a new study.    

Researchers from the University of California, San Francisco, say for-profit dialysis centers continued to give patients large amounts of a class of anemia drug known as Erythropoiesis-stimulating agents (ESAs), even after a 2007 black box warning was added by the FDA warning that they should be using as little of the drugs as possible on their patients.

The study, published in the JAMA Internal Medicine medical journal on May 15, looked at the use of ESAs from February 1, 2007, before the warning was added, and compared the usage rates to those on February 1, 2008, after the warning.

Researchers found that both non-profit and for-profit dialysis centers showed reductions in use, but for-profit centers only dropped from 9,000 units per week to 8,300 units per week, while non-profit use of ESAs dropped from 5,600 units per week to 5,000 units weekly.

Experts say that it was not until 2011, when Medicare bundled all dialysis treatment costs together, so that there was no additional profit in using ESAs, that for-profit use dropped to levels comparable with non-profit use. However, there has been no study yet verifying that assumption.

Anemia Drug Health Risks

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are ESAs prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. However, following studies that suggested the drugs carry serious, sometimes deadly side effects, sales have dropped in recent years.

The FDA issued a public health advisory regarding the drugs in 2007, saying that the Anemia drugs could increase the risk of injury or death at high doses. The FDA required the black box warning to alerting patients to the cardiovascular health risks. The black box warning is the strongest label warning the FDA can require of a medication.

The drugs are already restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.

A $762 million settlement was reached in December to resolve an Amgen whistleblower lawsuit, which alleged the drug maker illegally promoted the medication. The lawsuit claims Amgen encouraged doctors to use the drugs by overfilling vials by as much as 25 percent. It also alleges the drug company offered doctors discounts to use the drugs in large volume.

Other scandals surrounding the anemia drug involve Amgen offering false information regarding the safety of the drug. The company is reported to continue the use of lobbyists in congress to pressure lawmakers and the FDA to overlook claims of potential severe side effects, such as an increased risk of cancer and stroke.