The Advancing American Kidney Health Initiative: The Challenge of Overcoming the Status Quo

We read with great interest the Perspective regarding the 2019 US Presidential Executive Order (EO) on Advancing American Kidney Health.¹ The authors of that article, based in Alberta and Ontario, are globally recognized leaders in home therapies, with views shaped by their experiences as medical professionals. They question the feasibility of the EO’s goal of increasing participation in home dialysis or transplant to 80% of the US ESKD population. They suggest that, in the United States, the challenge is even steeper than it is in Canada or Hong Kong because per capita resource utilization of RRT, the “denominator,” is higher in the United States than it is elsewhere in the world.

Half a century of dialysis has supported hundreds of thousands of lives, yet its continuing failure to evolve has given truth to a salient prediction, first noted in 1976, that “…satisfied with what we have wrought, … the technology of [renal failure] therapy will become entrapped in its own net for failure to break out in new directions.”² Decades of private and public underinvestment in innovations responsive to patients’ own priorities³ have resulted in a default mindset that the treatment of ESKD will forever remain a zero-sum game divided among scarce transplants, burdensome home therapies, and high-morbidity in-center dialysis. This utter failure to innovate ESKD care is not an orphan: indeed, there are multiple parents.

First, federal research dollars for renal disease in the United States lag far behind those for HIV, cardiovascular, and cancer research.⁴ Second, the molecular biology revolution may have led to overconfidence that cures for renal disease were rapidly approaching.⁵ Third, the corporate dialysis industry has long been seen, by both patient advocates and like-minded professional allies, as both medical and mercenary, marked by low points, including litigation against individual researchers over peer-reviewed research.^6,7 Finally, the academically based pioneers of dialysis have passed away—Kolff, Alwall, Nakamoto, Gotch, Sargent, Lysaght, Stewart, Blagg, and others—leaving less than a full bench of advocates for biomedical engineering within the academic nephrology community. The combination of scarce funding, overoptimism regarding the payoff from discovery science, and profits gained from maintaining status quo dialysis have blinded many in the nephrology community to the paradigm-shifting potential of biomedical engineering research and solutions.

It is imperative we invest more intelligently to develop therapies that make better sense for the 550,000 Americans and >2 million patients worldwide who have fallen through the cracks of prevention. The epidemiology of renal failure may evolve, but, sadly, ESKD is not going the way of smallpox and polio. Other disciplines devise ever-better treatments for cancer and cardiac diseases whereas kidney patients suffer the burden of dialysis. The EO identified the strategic importance of technology development in ESKD and brought attention to KidneyX, the unique public-private partnership between the US Department of Health and Human Services and the American Society of Nephrology (ASN). KidneyX is a prize competition designed to bring attention to the unmet needs of patients with kidney disease and encourage scientists and engineers from multiple disciplines to develop solutions on the basis of the lived experiences of patients with kidney disorders.

The Perspective’s authors far too quickly surrender the goal of 80% transplant and home therapy to failures of the imagination and the zero-sum game status quo of the past decades. In contrast, thinking beyond in-center dialysis was well within the bounds of imagination for the patients, family members, caregivers, and allied professionals directly involved in the creation of the EO. To patients, the most important audience, the document is a landmark in the revitalization of both American kidney policy and medical innovation. The path to realizing the goal is not reducing “the denominator” by steering patients to palliative care, as the authors suggest. The challenge, instead, is completing development of technologies that allow self-care for renal failure with negligible hardware or workforce requirements. This is a bioengineering problem that is eminently solvable within the lifetime of a patient reaching ESKD today. The financial resources required are insignificant in comparison to ongoing patient and taxpayer costs of hemodialysis treatments. A one-time cost of $50–$100 million could move new kidney technologies to a tipping point that would attract risk capital—a small sum compared with the annual cost of dialysis, quickly approaching $50 billion per year.

The time is now for nephrology to look to the future, embrace patient-centered goals like those in the EO, and redouble our commitment to increased patient survival and independence. Every kidney professional, from those just beginning their practice to academic leaders, should have the same sense of urgency that patients have to save more lives by increasing the numerator through innovation, rather than dwelling on the status quo denominator.

Disclosures

P.T. Conway reports serving on a speakers bureau for American Association of Kidney Patients (AAKP; nonpaid); serving in an advisory or leadership role for the AAKP (chair of policy/global affairs and past president), CJASN (Patient Voice editor), Congressionally Directed Medical Research Program of the Department of Defense, External Expert Panel of the Kidney Precision Medicine Project, Kidney Health Initiative, National Institutes of Health (NIH), Nephrology Specialty Board of the American Board of Internal Medicine, and Patient Engagement Advisory Committee of the Food and Drug Administration (FDA; chair); having other interests in or relationships with AAKP/George Washington University School of Medicine and Health Sciences Global Summit on Kidney Disease Innovations (co-chair), Centers for Disease Control Health Infections Control Practices Advisory Committee, Center for Medicare and Medicaid Services (CMS) Dialysis 5 Star technical expert panel (TEP) (co-chair), FDA Cardiovascular Devices Advisory Committee, FDA Medical Devices Advisory Committee (chair), United States Renal Data System Contract Management Board, University of Pittsburgh/NIH Caring for Outpatients after Acute Kidney Injury (AKI-COPE) Study Advisory Board, and World Health Organization Lived Experience Research; receiving honoraria from Baxter, Global Transplant patient reported outcomes (PRO) Patient Advisory Committee, and Novartis; and being employed by Conway Strategies Global. W.H. Fissell reports having ownership interest in Silicon Kidney LLC, and having patent royalty distributions for intellectual property related to renal replacement and tissue engineering. N. Gedney reports receiving honoraria from the ASN, IDEAs, and University of Washington; and being employed by Home Dialyzors United. S. Roy reports serving in an advisory or leadership role for Biomedical Microdevices (associate editor), Sensors (editorial board), and Sensors and Materials (editor); having other interests in or relationships with Home Dialyzors United (board member); having ownership interest in Silicon Kidney LLC; having patents or royalties with the University of California (patent royalty); and having consultancy agreements with Vitara Biomedical GLG.

Funding

None.

Author Contributions

All authors wrote the original draft and reviewed and edited the manuscript.