The GranuFlo Lesson: Are We Failing Our Dialysis Patients?

Jeffrey S. Berns, MD


July 10, 2012

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Hello. This is Jeffrey Berns from the University of Pennsylvania School of Medicine in Philadelphia. I am Editor-in-Chief of Medscape Nephrology.

Two items recently caught my attention. The first is the news stories about the problems related to the use of GranuFlo®, manufactured by Fresenius Medical Care North America and non-Fresenius units around the United States.[1] There is a very distressing news article and discussions that have been going on. I don't know how this is going to turn out. I suspect that there will be some litigation and FDA decision-making that we will have to wait for, but the issue is the cause of metabolic alkalosis related to the use of a product called GranuFlo in the manufacturing of dialysate.

It appears from news stories that there may have been adverse consequences -- including deaths -- related to the use of this product, and there is a discussion about who knew what at what time, who was informed of these problems in a timely fashion, and so on. Again, I don't know what is true and what will ultimately happen, but it just points out to me how we as a community of physicians and providers who take care of dialysis patients have had such a difficult time doing the right thing. Bad things happen to our patients and sometimes it's of their own doing, but this is a circumstance that should make us take a hard look at ourselves and think about what we do and how it affects the care of our patients.

I don't know whether this is an issue of for-profit vs not-for-profit involvement in the dialysis industry, but it is distressing. We as a community seem to have a very difficult time doing the right thing all the time for our patients, but we should do the right thing all the time for our patients.

The other item is a recent editorial that was in the Clinical Journal of the American Society of Nephrology.[2] It was written by several very prominent figures in nephrology in the United States: Drs. Parker, Straube, Nissenson, Hakim, Steinman, and Glassock. It is a commentary called "Dialysis at a Crossroads--Part II: A Call for Action." They highlighted several areas of care of dialysis patients in which we should be doing a better job, including avoidance of catheters and transitioning to arteriovenous (AV) access, intensifying dialysis, better nutritional management, better attention to anxiety and depression, better extracellular volume control, more aggressive management of patients during the first 120 days of dialysis, and more kidney transplantation and home dialysis.

I laud the authors of this paper for their efforts in bringing some of these problems in the care of dialysis patients to our attention. Clearly, we need to move away from the notion of providing adequate dialysis to the notion of providing optimal dialysis to every single patient every time they come to a dialysis facility. I would challenge the authors of this paper, and maybe the dialysis community at large, to go even further: to start from the beginning and think about what dialysis ought to look like if we were starting, from the beginning, unconstrained. Would we do 3-4 hours of dialysis 3 times a week? Would we do 4, 5, 6, or 8 hours of dialysis every other day? Would we choose a surgeon who doesn't have a great track record when it comes to creation of AV access to put in an AV fistula or graft? Would we even allow patients to start dialysis with a catheter? Maybe that's not the way to go.

I know it's pretty extreme, but we need to think better about managing dialysis and maybe think about providing dialysis that, in each and every single patient of ours, eliminates the need for phosphate binders and eliminates the need for antihypertensive therapies. We need to focus on a different metric and different outcomes. As these authors mentioned, we need to stop looking at the process for quality measures and look at outcome. We are never going to have the randomized controlled trials that we need to support outcome measures in every aspect of dialysis care, so we have to take our best guess while also doing our best to avoid unintended consequences -- really providing better care to our patients.

I challenge physicians and providers of dialysis to step up and not wait for CMS or other organizations to create clinical practice guidelines, but to take it upon themselves to provide better care in every arena as it relates to dialysis patients. Patients will clearly benefit if we pay more attention to the details of what we do, avoid harming them (if that was an issue related to the GranuFlo matter), and really look at providing the absolute best care rather than just adequate care to dialysis patients.

I would be interested in any comments or thoughts you have. Please send them in. Thanks for your attention. Again, this is Jeffrey Berns, Editor-in-Chief of Medscape Nephrology.


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