The recent publication of the CHOIR and CREATE studies in the New England Journal of Medicine questioning hemoglobin targets in dialysis patients have resulted in intense scrutiny of the relationship between Amgen, dialysis organizations, and physicians in the management of anemia. Last month, the U.S. House Ways and Means Committee held hearings on the matter. What is all the fuss about?
Medicine has been falling more and more under the aegis of guidelines, prompting fear among many physicians that guidelines would be used as standards. Indeed, this is part of the problem when it comes to addressing anemia.
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The National Kidney Foundation (NKF) published its initial set of renal disease anemia guidelines in 1992, stating that the appropriate hemoglobin range should be 11-12 g/dL for patients with end-stage renal disease (ESRD). This is based on substantial data showing increased morbidity, mortality, and hospitalization rates for patients whose hemoglobin levels were less than 11 g/dL, although data supporting the upper limit of 12 was “softer.” This guideline recommendation was quickly used to determine reimbursement, which would be denied if hemoglobin levels were consistently greater than 12.
But because of natural biologic variability, the actual amount of time patients stayed within this narrow target was estimated to be less than 30%. Wide fluctuations were not only attributed to normal variation, but possibly to algorithms used to manage the administration of epoetin alfa.
The most recent iteration of the NKF guidelines contained an opinion-based recommendation that hemoglobin targets could be as high as 13 g/dL. Enter CHOIR and CREATE. These two studies, which focused on CKD rather than ESRD, created a firestorm on Capitol Hill, which considered the possibility that dialysis organizations and possibly physicians were overtreating patients with epoetin alfa and pushing profits ahead of clinical care.
The truth is that the data from both studies have not been fully adjudicated in the scientific community. If hemoglobin levels were being pushed inappropriately high, there would have been a spike in mortality over the years, which has not occurred. Physicians should remain loyal to their ultimate responsibility: the individual patient. Although it is prudent to achieve hemoglobin levels ranging between 11-12 g/dL, at times higher hemoglobins may be necessary.
