In response to growing evidence that the anti-anemia drugs known as erythropoiesis-stimulating agents, or ESAs for short, such as epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp), are harmful to people who have cancer by speeding the growth of tumors and shortening a person’s life, the FDA has mandated the development of a risk management program designed so that "patients and providers can make informed decisions," according to Dr. Richard Pazdur, the FDA’s Director of the Office of Oncology Drug Products.ESAs are approved to treat the kind of anemia related to kidney failure, certain types of chemotherapy, or the HIV drug AZT. These drugs are also used in some people who undergo surgery in lieu of getting a blood transfusion.
In this new program, people who are prescribed ESAs must be given a Medication Guide, which lays out the benefits and harms related to the drugs. Amgen, the drugs’ manufacturer must also ensure that only hospitals and healthcare professionals who have completed training can prescribe and dispense ESAs to people with cancer.
The reality is that the ESAs have been on thin ice as a treatment for anemia in cancer patients for nearly four years. We have warned against their use in people who have a chance of recovery from cancer, and with caution in people who have kidney disease or who take ESAs instead of getting a blood transfusion.Even though this is the first time, as far as we can tell, the FDA has resorted to confirming that health care providers are properly trained to use a product, this risk management tactic will surely only limit—but not halt—the number of people who are exposed to ESAs. It is puzzling that the FDA avoided the ultimate step to ensure patient safety: withdrawing the approval of ESAs in cancer patients altogether. It seems quite clear that the risks of these drugs in most people with cancer far outweigh any potential benefit.
Since the FDA requires Amgen to watch over the progress of these risk management programs, you may be struck with that mildly queasy feeling when one realizes that, indeed, the fox is guarding the hen house.And, if it looks like the manufacturer doesn’t adhere to this arrangement?
"Initially, we are not focusing on penalties but assessing the best way to achieve the goals of the program," said Dr. Patricia Keegan, the Director of the Division of Biologic Oncology Products, at the FDA. When asked during a briefing call on Tuesday what the FDA can do if the manufacturer fails to monitor the program properly, said Pazdur, "we’ll have to get back to you on that."—Alan Cassels, guest blogger
Alan is a drug policy researcher at the University of Victoria, British Columbia and co-author of "Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients."