Creation/Revision Date: October 25, 2010
Testimony presented before the Food and Drug Administration (FDA) Center for Drug Evaluation and Research
by Edward Jones, M.D.
President, Renal Physicians Association
October 18, 2010
RPA Written Statement
My name is Edward Jones. I serve as President of the Renal Physicians Association, a national organization whose mission in part is to promote high quality of care and safety for patients with chronic kidney diseases. RPA represents practicing nephrologists, who are predominately responsible for prescribing ESAs to kidney patients in the U.S.
While the use of ESAs and iron have reduced the numbers of patients with profound anemia and transfusion requirements, recent studies including TREAT have raised substantial concern about the safety of ESAs when used to target a Hgb “to approximately 13 gm/dl”. Importantly, the current nephrology standard of practice guiding the administration of ESAs does not target Hgb to 13. The current practice in the use of ESAs is to achieve a Hgb range of 10-12 while keeping Hgb above 10 to avoid transfusions and improve the quality of life.
While we now know we must monitor ESA prescriptions carefully to avoid high Hgb levels or very high ESA doses, we cannot forget the danger of leaving our patients with low Hb. Observational data indicates higher patient mortality with Hgb <10. In addition, blood transfusion requirements increase with Hgb< 10 and therefore decreases the chances of successful transplantation. Indeed, TREAT demonstrated higher transfusion requirements in the placebo patients.
TREAT studied ESAs use in non-dialysis CKD, and demonstrated adverse events when Hgb is targeted to 13 and increasing doses of ESAs are used to achieve the targeted values. However, these results are not necessarily applicable to CKD patients on dialysis who have higher co-morbidities. Therefore data from TREAT or other similar studies in non-dialysis CKD patients should not be extrapolated to the patients on dialysis without data in the dialysis patient population.
RPA strongly believes that policy decisions should not interfere with clinical decision making unless evidence-based clear cut safety issues are demonstrated which is not the case under current prescribing guidelines. Neither TREAT nor any other study has demonstrated patient safety issues with use of ESAs to raise HgB above 10 and achieve Hgb 10-12, as the package insert notes. Current practice guidelines and the package insert will minimize transfusions and potentially improve quality of life.
It is important to remember that evidence based medicine is designed for use at the individual patient level. As policy in this area is developed, RPA urges the FDA to preserve the ability of doctors and patients together to consider the risks and benefits and make individualized patient care decisions about ESAs or other therapies one at a time at the bedside.
Finally, well designed, placebo-controlled studies evaluating ESA use are needed to ensure patient safety and appropriate use of ESAs.
On behalf of the Renal Physicians Association, I thank you for this opportunity to speak today.