Tampa, Fla. –On Tuesday, September 11, 2007, the American Association of Kidney Patients (AAKP) testified before the Food and Drug Administration’s (FDA) joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees discussed updated information on the risks and benefits of erythropoeisis-stimulating agents (ESAs) when used in the treatment of anemia due to chronic renal failure.

Recent reports of studies with ESAs have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents. ESAs stimulate the bone marrow to make more red blood cells and are FDA approved for use in reducing the need for blood transfusions in patients with chronic kidney failure, patients with cancer on chemotherapy, patients scheduled for major surgery (except heart surgery) and patients with HIV that are using AZT.

AAKP President, Roberta Wager, RN, MSN, a two time kidney transplant recipient addressed the committee on behalf of the Association. Wager told the Committee, “AAKP supports achieving a hemoglobin level of 11 to 12 grams per deciliter, as indicated by the FDA label for ESAs.” She went on to say, “ We view the current CMS Monitoring policy as somewhat out of sync with where the FDA is and where the mainstream medical community is. Although each case is different and there will always be outliers, from a patient perspective there is very little medical reason for a patient to remain at levels above 13 grams, especially in light of the current literature citing safety issues.” Wager also shared with the Committee how ESAs helped her as a hemodialysis patient.

Some study results have shown patients with chronic kidney failure had an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain higher red blood cell levels (hemoglobin more than 12 g/dL). AAKP believes the management of anemia should be determined by the patient’s needs and the decision-making shared with the physician.

According to Wager, “Separate Medicare reimbursement for ESAs potentially distracts from the doctor/patient decision-making relationship, so we support bundling Medicare reimbursement for ESAs into the overall Medicare reimbursement rate. We believe that bundling the payment would not only result in cost savings, but also would result in more appropriate dosing of ESAs and draw more attention to the comprehensive nature of kidney care.

To read AAKP’s full testimony to the FDA, click here. You can also request a copy of the testimony by calling AAKP at (800) 749-AAKP.