Dialysis Unplugged: “Waiting for Godot”

Editorial - Dr. Ajay K. Singh

In “Waiting for Godot” (1), one of the foremost plays of the 20^th century, the Nobel laureate Samuel Beckett depicts the passivity of waiting: two men sitting idly distracting themselves with false expectations and self-delusions, waiting passively for someone they hardly know. As Hooti describes it: Waiting for Godot is about "a ceaseless waiting, about repetition, the meaninglessness, the absurdity of waiting … it is about.. the responsibility of a better future that we are not quite fully convinced will [never] arrive."

One could argue that in waiting for change in the dialysis world we are waiting for Godot. Should we just continue waiting?

Many believe that more dialysis delivered frequently or nocturnally is better. This is founded on a belief – first published (2) over 30 years ago – that the current schedule is unphysiologic. Studies reinforce the validity of this belief. The costs to the United States tax-payer will almost certainly be lower. The late Dr. Belding Scribner, a dialysis pioneer and one of the greatest nephrologists of our generation, said at the 2003 Annual Dialysis Conference in referring to the benefits of more frequent dialysis: "healthy, well-nourished, normotensive hemodialysis patients will incur lesser additional health care costs than their sickly, malnourished, hypertensive counterparts on short three times weekly hemodialysis."

However, to gain traction and fundamentally change the way dialysis is structured requires more than evidence and strong beliefs. In my view, it requires the FDA to oversee the dialysis prescription coupled with a sustained campaign targeted at Congress.

The FDA should oversee the dialysis prescription

Currently, with the very notable exception of the dialysis prescription, the Food and Drug Administration (FDA) regulates virtually everything else in the dialysis procedure. From the dialysis tubing to the dialysate and medications administered during dialysis to the dialysis system itself. Why not the dialysis dose? Doctors prescribe dialysis as a function of the dialyzer they use (the “k”) and the time (the “t”). We also prescribe the frequency of dialysis. 

Evidence suggests worse outcomes with the current dialysis schedule and that more frequent dialysis is associated with improved outcomes. What we prescribe impacts outcomes: too little or none at all and patients do worse, more frequent dialysis and patient’s do better. A physician must sign the individualized prescription and any changes to it. However, there is no regulatory scrutiny to what we do. There is no “label”, like there is for a drug, crafted by an independent governmental body, on how much we prescribe.

Is dialysis a drug? If one uses the FDA’s own definition of a drug the answer is yes. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. The FDA should be regulating dialysis as a matter of law.

If the FDA were to regulate the dialysis prescription they would need to oversee it’s safety, it’s delivery, and it’s optimal dosing. The dialysis industry would need to present evidence purporting to safe dosing of dialysis and a committee would need to advise the FDA as to what is safe. Regulatory scrutiny of dialysis could result in change -- just see what happened to ESA dosing.

While we are far removed from the era of nostrums, surprisingly there is no federal scrutiny of a drug that is used in over 550,000 Medicare beneficiaries in the United States. That should change.

Kidney Care Partners and advocating for dialysis patients

The lobbying group Kidney Care Partners (KCP) presents itself as “a coalition of patient advocates, dialysis professionals, care providers and manufacturers working together to improve quality of care for individuals with Chronic Kidney Disease.” Really? More like the “fox protecting the henhouse”. We need leading dialysis advocacy organizations like Dialysis Patient Citizens, the National Kidney Foundation, and others, to separate themselves from KCP and directly lobby congress for modifications in how dialysis is reimbursed so that frequent dialysis can be offered to patients in the US.

Ron Kuerbitz, Executive Vice President for Fresenius Medical Care-North America, is KCP’s new Chairman for the 2011-2012 term. Kuerbitz takes the KCP reign from Kent Thiry, CEO of DaVita, who held the post previously. There is a dim likelihood that, with current KCP leadership, much will change in how dialysis is structured with respect to frequency. Kuerbitz is quoted as saying "As KCP chairman, my goals are two-fold. First, I am committed to maintaining the kidney care community's focus on efforts to continuously improve the quality of dialysis care, especially with regard to significantly increasing survival rates of individuals with ESRD during their first year on dialysis – our 'PEAK' campaign must remain a top priority," "Also, I believe we have a significant opportunity to deepen public and policy maker understanding of kidney disease and its relationship to the obesity and diabetes epidemics."

There is absolutely nothing wrong with KCP advocating for its positions. It is in truth a lobbying organization representing the interests largely of its commericial members, who in turn, represent the interests of share-holders. However, maintaining the status quo, especially if the dialysis industry is prospering from it, may be quite different from the interests of patients.

Evidence that KCP wants to maintain the status quo comes from its response to the Atlantic magazine titled  “God Help You. You're on Dialysis.” . No-where in its talking points on how dialysis might be improved is there a statement that it would work towards structuring dialysis care to make it more physiological. No-where. This must change.

Bottom line - In the United States, dialysis is not a privilege it is a right, codified by statute, that should be comprehensively regulated by a government agency. It should be advocated independently by dialysis patient advocacy organizations. Optimizing the dialysis prescription is one area where Waiting for Godot just won’t do.

References

1. Becket, Samuel. (1956). Waiting for Godot. London: Faber.

2. Kjellstrand CM, Evans RL, Petersen RJ, Shideman JR, von Hartitzsch B, Buselmeier TJ. The "unphysiology" of dialysis: a major cause of dialysis side effects? Kidney Int Suppl. 1975 Jan;(2):30-4. PubMed PMID: 1057690.