The New York Times reported on January 25, 2007 that Amgen, the manufacturer of the anti-anemia drug Aranesp, has acknowledged an increased risk of death when this drug is used to treat certain cancer patients. Aranesp, Epogen (also from Amgen), and Procrit (from Johnson & Johnson) are three anti-anemia drugs that have been used for what are called “off label” purposes. “Off-label” purpose means a use not approved by the FDA.
Recently an Amgen executive vice president estimated that about 10 percent to 12 percent of Aranesp sales are used for “anemia of cancer.”
Amgen’s disclosure related to recent clinical trials involving Aranesp. Amgen’s stated goal in these trials was to see whether Aranesp could reduce the need for blood transfusions to treat anemia caused by certain cancers.
Amgen now says that the company found that the drug did not reduce the need for transfusions compared with a placebo, but did increase the number of deaths by the end of 16 weeks by a statistically significant amount. While Amgen did not provide any numerical results from the trial, the company said in a news release that in this particular population the “risk/benefit ratio for Aranesp use is at best neutral and perhaps negative.”
According to today’s New York Times article, the sale of anti-anemia drugs is a $10 billion business for the drug companies. The drugs are marketed globally; about one million American patients receive prescriptions for this class of drug every year.
Earlier this fall, I wrote about the risks posed to dialysis patients when Epogen, Amgen’s other anti-anemia drug, was overused by dialysis patients. Responding to current research reports, I wrote that most dialysis clinics administer the anti-anemia drugs intravenously rather than by injection. As a result, each patient gets about one-third more drug than the patient would need if he/she received the drug by injection.
After the Epogen/dialysis story broke, on November 30, 2006, the New York Times reported that an expert panel of doctors for the National Kidney Foundation plans to study whether the intravenous administration of the anti-anemia drugs to hundreds of thousands of patients with kidney disease is subjecting the patients to unnecessary threat of harm. The purpose of the study is to determine whether to change guidelines for how patients should be treated.
You can read the entire New York Times article, here.