Chronic Kidney Disease v. Chronic Kidney Failure
by billp830, Sun Apr 29, 2007 at 03:46:06 PM EDT
While looking into the documentation regarding the FDA "Black Box Warning" on the use of drugs to treat anemia I came across what I consider incorrect word usage. I think this sloppy use of language has added a layer of confusion to an already complex issue.
The FDA document Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) uses the terms: Chronic Kidney/Renal Failure and Chronic Kidney/Renal Disease interchangeably. They are not the same thing.
Kidney or renal, I say kidney. Chronic Kidney Disease describes a progressive condition usually divided into five stages. Stage One - CKD1 - is mildly diminished kidney function. From there kidney function continues to diminish until Stage Five - CKD5 - also know as Chronic Kidney Failure or in Medicare-speak End Stage Renal Disease (it should be obvious why people with CKD5 are not thrilled with either the Chronic...Failure or End Stage labels). A person with CKD5 needs dialysis or a transplant to stay alive.
The FDA document includes the bold, italics font (double emphasis) headline "Studies in patients with chronic renal failure" and then discusses the CHIOR and CREATE studies which were studies of people with CKD3 & CKD4. The FDA does correctly note that these studies looked at the impact of Hemoglobins at or greater than 13.5 in people with CKD. To say that these were studies on "patients with chronic renal failure" is wrong, that would be dialysis or transplant patients these were neither.
From here it is a short leap to get to the US dialysis patient anemia management program which is a 2 billion dollar a year piece of the dialysis entitlement. As a commenter noted on one of Matt's posts, people can adapt to anemia. I know people who went to school, worked, raised families while on dialysis in the period before ESAs when low hemoglobin was treated with transfusions to keep hemoglobin levels above 7. I had a transfusion in 1987 while I was a VISTA because my hemoglobin dropped below 6. So I could function with a hemoglobin in the 7 to 10 range. But don't tell me the policy change is for my benefit.
Talking about people who are on dialysis there are many studies showing the clinical benefit of maintaining a hemoglobin up to 12 through the use of ESA.
# Delano BG. Improvements in quality of life following treatment with r-HuEPO in anemic hemodialysis patients. Am J Kidney Dis. 1989 Aug;14(2 Suppl):14-8
# Stevens JM, Auer J, Strong CA, Hughes RT, Oliver DO, Winearis CG, Cotes PM. Stepwise correction of anaemia by subcutaneous administration of human recombinant erythropoietin in patients with chronic renal failure maintained by continuous ambulatory peritoneal dialysis. Nephrol Dial Transplant. 1991;6(7):487-94
# Levin NW, Lazarus JM, Nissenson AR. National Cooperative rHu Erythropoietin Study in patients with chronic renal failure Ð an interim report. Am J Kidney Dis. 1993 Aug;22(2 Suppl 1):3-12
# Glaspy J. Phase III clinical trials with darbepoetin: implications for clinicians. Best Pract Res Clin Haematol. 2005;18(3):407-16
# Furuland H, Linde T, Ahlmen J, Christensson A, Strombom U, Danielson BG. A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients. Nephrol Dial Transplant. 2003 Feb;18(2):353-61
According to MedPAC Medicare spending for outpatient dialysis and injectable drugs administered during dialysis was about $7.6 billion in 2004 (the most recent data available). That's a lot of money even by federal budget standards. We taxpayers should ask what we're getting for our money; I think a close look reveals that Medicare is getting value for its dollar. Even the spending on ESAs is a good investment.