42 Deaths in Clinical Trial
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Ortho Biotech, a Bridgewater, New Jersey-based Johnson & Johnson subsidiary, reports that 42 patients have died in a test of the anemia drug epoetin alpha. The German institute conducting the study denies the report.
Epoetin alfa, which belongs to a class of drugs known as erythropoiesis-stimulating agents or ESA, is a bioengineered form of a protein made in the kidneys that is critical to red-blood cell production
ESAs are approved in the U.S. to treat anemia in patients with kidney disease and HIV, and cancer patients with chemotherapy-induced anemia.
However, ESAs have come under scrutiny over the past two years because of reports of adverse cardiovascular events and cancer linked to the drugs.
A spokesperson for the Max Planck Institute for Experimental Medicine in Munich, Germany called release of the information premature and the result "of some sort of panic attack."
The institute was conducting a study using epoetin alpha to treat stroke patients.
Ortho Biotech markets epoetin alfa in the U.S. as Procrit under a license from Thousand Oaks, Calif.-based Amgen Inc., which markets its own version of the drug as Epogen.
Preliminary results from the 512-patient study showed that 42 patients died in the treatment arm compared with 24 in the placebo arm..
Epoetin alfa, which belongs to a class of drugs known as erythropoiesis-stimulating agents or ESA, is a bioengineered form of a protein made in the kidneys that is critical to red-blood cell production
ESAs are approved in the U.S. to treat anemia in patients with kidney disease and HIV, and cancer patients with chemotherapy-induced anemia.
However, ESAs have come under scrutiny over the past two years because of reports of adverse cardiovascular events and cancer linked to the drugs.
A spokesperson for the Max Planck Institute for Experimental Medicine in Munich, Germany called release of the information premature and the result "of some sort of panic attack."
The institute was conducting a study using epoetin alpha to treat stroke patients.
Ortho Biotech markets epoetin alfa in the U.S. as Procrit under a license from Thousand Oaks, Calif.-based Amgen Inc., which markets its own version of the drug as Epogen.
Preliminary results from the 512-patient study showed that 42 patients died in the treatment arm compared with 24 in the placebo arm..
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