This article is more than 5 years old. Information may no longer be current.
Is a Risk Evaluation and Mitigation Strategy necessary for erythropoiesis-stimulating agents?
REMS presented in the wrong light.
My concern about the REMS program for recombinant epoetin products is that it has been presented in a punitive manner rather than in a constructive manner. We have REMS programs associated with other drugs in hematology such as thalidomide and in that situation, I think it’s very important that physicians have some education about the drug before prescribing it, and that they understand there is some obligation on their part to monitor side effects.
Regarding the epoetin issue, particularly in the hematology field, the issue is much murkier than it is in solid tumor malignancies where the statistics suggest that giving recombinant epoetin might increase the death rate in patients. In the hematologic diseases, it’s not quite that clear.
Although I agree with the idea that physicians should be aware of monitoring longitudinal side effects, requiring computer-based educational programs before a physician has the right to prescribe these drugs is the wrong way to go. It seems more punitive and more directed at trying to reduce the cost of medical care than to reduce long-term side effects from the use of the drug.
Where is the REMS program concept going to end? Are we going to get REMS on all new chemotherapy agents or all new monoclonal antibodies?
Once we learn about bevacizumab and the hypercoagulability complications of all the antiangiogenetic drugs, are all of those drugs going to be forced into REMS programs to reduce their use and perceived side effects?
What percentage of adverse events should trigger a REMS program? In actuality, it’s very difficult to know what the real significance of these drugs are in causing the death of patients.
All of these concerns could be addressed if, when the decisions are made, they are made in conjunction with representatives from ASH and ASCO who have the expertise in these areas.
Craig M. Kessler, MD, is professor of medicine and pathology in the division of hematology and oncology at Lombardi Comprehensive Cancer Center in Washington, D.C.
The FDA requires a REMS, so we will obey the FDA.
Since the FDA requires REMS, we will comply with the new restrictions. Although we have been using ESAs safely, for some reason or another, the FDA became stricter about their use.
This restriction, as far as we understand it, applies only to chemotherapy-induced anemia and not to patients with myelodysplastic syndromes. The reason for that is the different mechanism of anemia between the two situations.
Patients who develop chemotherapy-induced anemia have, in most cases, normal bone marrow before receiving chemotherapy. Patients with myelodysplastic syndromes have abnormal marrow, and that is the essence of their disease. Some patients with low-grade myelodysplastic syndromes benefit from ESAs, and therefore the REMS do not apply to them.
The potential for side effects is also different. Patients with chemotherapy-induced anemia may increase their hemoglobin to higher than normal levels, while it is less likely in myelodysplastic syndrome patients.
Meir Wetzler, MD, is chief of the leukemia section and assistant research professor in the department of immunology at Roswell Park Cancer Center, Buffalo, N.Y.