Studies Show that Costly Anemia Drugs Cause Harm
As reported in the New York Times, new studies show that costly biotech drugs for treatment of anemia may cause more harm than good. Erythropoiesis-stimulating agents (ESA), made by recombinant DNA technology, are used to treat certain types of anemia such as those associated with cancer and chronic kidney disease. ESAs are generally used to decrease the need for blood transfusions. The agents should be administered as described in the package labeling to reach a targeted hemoglobin level, which signifies that the anemia has improved. However, these agents are often used for non-FDA approved indications and at doses exceeding the FDA approved recommendations.
A recent study of cancer patients not currently on chemotherapy showed that patients treated with darbepoetin alfa (Aranesp, Amgen) experienced a higher death rate and no reduction in the need for transfusions. The FDA plans to review and analyze the study results once submitted by Amgen. Aranesp and other marketed agents in this class, epoetin alfa (Epogen, Amgen) and epoetin alfa (Procrit, Johnson & Johnson) are only FDA approved to treat anemia in cancer patients receiving chemotherapy.
In previous studies, the FDA noted an increase in mortality and possible tumor promotion and thromboembolic events (blood clot that is formed, breaks away and blocks a major blood vessel) in patients treated to targeted hemoglobin level (>12 g/dL), which is higher than the recommended FDA approved labeling. Two recent clinical studies addressed safety concerns with the use of Procrit. Compared to patients who were targeted to lower hemoglobin levels, patients targeted to higher hemoglobin levels experienced increased serious and potentially life threatening cardiovascular events.
Recently, Roche halted recruitment for its Cera trial, a new ESA in phase II clinical trials. The trial was stopped due to an imbalance of deaths across the four study arms. Investigators state, “the deaths appear to be unrelated to the study drugs and that there is no relationship to the targeted hemoglobin levels.” Currently, Amgen is suing Roche for patent infringement.
The combined sales for ESAs reach about $11 billion annually. These high cost products often make up a large component of the pharmacy budget. Based on a study conducted at Baylor University Medical Center in 2002, costs for these agents ranged from approximately $124 weekly up to $303 weekly depending on the ESA used and dosage requirements. Appropriate utilization (patient selection and dosing) can help decrease the risk of adverse events and the costs associated with the use of these agents. As a result of the numerous safety issues, the FDA (.pdf) recommends avoiding treatment with ESAs in anemic cancer patients not currently on chemotherapy. Additionally, in all treated patients, the FDA approved dosing recommendations and monitoring parameters should be followed.
March 1, 2007 Related topics: Quality, Safety, Errors, Renal & Urology, Hematology & Oncology, Pharmaceuticals, Evaluation & assessment