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190 End-Stage Renal Disease Patients Die Each Day: Epogen Usage Questioned

June 11, 2004

Seminars in Dialysis, a peer-reviewed journal published by Blackwell Publishing, is featuring the much-publicized* controversial editorial authored by Dennis Cotter in its May issue, despite outright rejection from a competitive journal, Dialysis and Transplantation.

Cotter asks the important question as to the actual benefit of higher Epogen dosages given to patients suffering from end-stage renal disease in his article entitled, "Improved Survival with Higher Hematocrits: Where is the Evidence?" Cotter's analysis brings attention to collective data from various studies; for example, data requested by Centers for Medicare and Medicaid Services (CMS) to determine if Medicare's spending on Epogen dosages for dialysis patients is "reasonable and necessary" for patient survival.

"Approximately 190 end-stage renal disease patients die each day," states Cotter. However, "we conclude that there is no basis for inferring the survival benefits or detriments of increasing a patient's hematocrit by adjusting the dosing of epoetin." Cotter's analysis highlights the concern and need for additional review as it affects patient survival and whether spending an additional $6,000 on each of the over 100,000 patients receiving treatment each year is a wise decision for CMS.

Disagreeing with the National Kidney Foundation's association of survival through "higher hematocrits achieved through epoetin treatment", Cotter's analysis concludes that previous findings are incomplete. The key factors in his analysis include the relative health of patients throughout the duration of the studies, errors in the analysis of the relationship between "treatment response from higher doses of Epogen and actual outcome" in addition to the idea of a "causal effect of treatment."

*For initial coverage of article rejection and controversy, see "Journal rejects article after objections from marketing department" by Owen Dyer, British Medical Journal, Volume 328 January 31 2004, page 244 and "Business, Science Clash at Medical Journal" by Shankar Vedantam, Washington Post, Saturday, February 7, 2004, page A02. The controversy surrounding this article began when first rejected from being published because it was considered inflammatory to the pharmaceutical industry and their advertising influences. The article is now receiving the chance to be read and discussed so clinicians can review the best treatment course for their dialysis patients. Additional background on the suppression of this paper can be found at http://www.wame.org/marketing.htm.

Blackwell Publishing Ltd