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Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients

Thursday, September 13, 2007 General News J E 4
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WASHINGTON, Sept. 12 The following is astatement by KCP Chairman Dr. Edward Jones:

Yesterday's FDA Advisory Committee meeting underscores the manyconsiderations that must be factored in to policymaking related to anemiatreatment in patients suffering from chronic kidney disease. The kidneycommunity salutes FDA for working with scientists, practicing nephrologists,and other members of the medical community to achieve a consensus onhemoglobin and dosing levels for erythropoietin-stimulating agents (ESAs)based on different patient populations. The community is unified in itsbelief that patient quality of care and quality of life must be taken intoaccount as physicians treat anemia in kidney patients. Patients with chronickidney disease and those on dialysis depend on ESAs to stimulate red bloodcell production in their bodies.

Anemia-management drugs have been well demonstrated to improve quality oflife for kidney patients and provide significant medical benefits. Unlikepatients with cancer, patients with chronic kidney disease are permanentlyaffected by anemia, which in turn affects their ability to engage in day-to-day activities that non-patients take for granted -- caring for theirfamilies, holding a job, and going to school. Without ESA therapy, ESRDpatients may develop hemoglobin levels that are dangerously low. Before ESAswere available, blood transfusions were required in most kidney patients.Transfused patients often suffered from heart failure, iron overload, andother chronic problems.

Several studies have demonstrated improvement in the morbidity andmortality of patients with kidney disease and kidney failure by theappropriate management of their anemia. After extensive review of the resultsof six new studies, a National Kidney Foundation Kidney Disease OutcomesQuality Initiative (KDOQI) work group updated its Clinical Practice Guidelineon Anemia this month and recommended that ESA therapy in dialysis and non-dialysis CKD patients should target hemoglobin levels in the range of 11 to 12g/dL. These guidelines are scientifically based.

The FDA panel members reaffirmed current dosing practices and votedagainst limiting the upper threshold of hemoglobin levels to 11.Additionally, the FDA made it clear that the label instructions were neverintended to result in EPO doses being withheld if a patient's hemoglobin levelexceeded 12. Further, the committee stressed the need for small incrementaldose adjustments of ESAs in an effort to minimize hemoglobin variation aroundthe target. Dr. Ellis Unger specifically raised this as he emphasized theimportance of focusing on best practices and the importance of minimizing therate of rise and rate of fall in hemoglobin. The community urges CMS toconsider these findings as they implement the Erythropoietin Monitoring Policy(EMP) used to treat anemia in ESRD patients.

The complexities of ESA dosing were readily apparent during yesterday'sAdvisory Commission's discussion, and we appreciate the panel's thoughtfulconsideration of the impact its decision will have on patients.

KCP is a nationwide alliance of representatives from the entire kidneycare community, including patients and their advocates, nephrologists, nurses,dialysis care providers, and manufacturers who have joined together to improvethe quality of care and quality of life for individuals suffering from kidneydisease and kidney failure.

SOURCE Kidney Care Partners
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