Inventor Dean Kamen said he is hoping to one day put himself out of business in both the dialysis and insulin pump industries. He created the first insulin pump and the first home peritoneal dialysis machine. The home hemodialysis machine he helped develop is currently being tested in an in-center clinical trial as part of CVS Health’s foray into home dialysis.
“We shouldn't be making insulin pumps for kids, we should be transplanting beta cells in the pancreas,” Kamen said during a Kidney Week 2019 state-of-the-art plenary talk. “We should not be doing dialysis. We should give people a replacement kidney.”
The inventor, who has more than 440 patents to his name including one for the Segway, acknowledged that new technologies and the disruption they bring can be frightening. But he challenged nephrologists to embrace the changes that transformative technologies are bringing to the field. Kamen was joined in the plenary by Bruce Culleton, MD, vice president and chief medical officer of CVS Kidney Care, and ASN Executive Vice President Tod Ibrahim.
“We’re not going to slow down the pace of the advancing technology,” Kamen said. “You can be on the bus or you can be under the bus of this accelerated pace of technology. I plan to be on it.”
Stalled progress
Inequity and poor outcomes currently plague the more than 850 million patients with kidney disease around the world. Many patients globally die without access to any care, Ibrahim noted. Additionally, 13 die each day on the US transplant waitlist while 77 usable kidneys are discarded and most dialysis patients die within 5 years, he said. Patients who are not white are more likely to progress to kidney failure and less likely to have access to home dialysis, he said.
Culleton cited a letter he received from a 72-year-old patient who had been on dialysis since 2018. She deals with low blood pressure, vomiting, and vertigo and is often unable to go to church, family engagements, or even on a hike with her dogs.
“It’s very isolating and depressing,” Culleton said. “It shouldn’t come to anyone’s surprise that about 20% of all patients who are on dialysis that die, do it intentionally and withdraw from dialysis.”
Despite these pressing needs, progress in the field has stalled technologically, Ibrahim noted. He cited underfunding from governments and investors in nephrology as one contributor. He noted that dialysis was created the same year as the mainframe computer.
“Seventy-six years later, we carry a more powerful computer in our pocket, yet mostly rely on the same technology to treat kidney failure in in-center dialysis,” Ibrahim said.
Home dialysis still lags, with only about 12% of dialysis patients receiving it, Culleton said. Most dialysis patients, he noted, begin with a catheter in their neck and at least one-third of patients with kidney disease receive no care prior to kidney failure, he said. The Centers for Medicare & Medicaid Services (CMS) pays more than $110 billion annually caring for patients with chronic kidney disease and kidney failure, Culleton said.
From dialysis- to patient-centered
But the speakers were optimistic that a combination of emerging technologies and the Advancing American Kidney Health initiative, announced by President Trump in July 2019, would help jumpstart progress in the field. Ibrahim noted that the ASN worked closely with the US Department of Health and Human Services to craft the program.
“This historic plan—the nation’s first kidney health strategy—aims to reduce the number of Americans with kidney failure by 25% over the next decade,” Ibrahim said. “The US government also intends to double the number of kidneys available for transplant and provide more options for people with kidney failure such as greater emphasis on alternatives to in-center dialysis.”
Kamin said progress is being made to speed the production of new technology for kidney care. For example, he noted the creation of the Advanced Regenerative Manufacturing Institute, which is working to scale up bioengineering technology. The institute has 150 members and has received $80 million in funding from the US Department of Defense and $214 million in matching funds from technology companies. They have already been able to demonstrate a system for generating induced pluripotent stem cells, which through an automated process can generate a 7-centimeter segment of bone and ligament in 40 days. They hope to be able to eventually create processes for making more sophisticated organs.
Kamen warned, however, that technology itself won’t lead to innovation. “The invention part is easy,” he said. “Getting the world to accept change is hard.” He noted it took 20 years to get CMS to cover the insulin pump despite endocrinologists’ enthusiasm.
“We need as a community to embrace these changes and fully move forward,” argued Culleton. “Nephrologists need to lead the way.”
Culleton acknowledged that being a nephrologist isn’t easy given the complexity of care and the regulatory demands in the field. But he said the field is in a position to reorganize kidney care around patients’ needs and that technology will play an important role, for example through better dialysis machines, telehealth, or machine learning to help identify patients with kidney disease.
“This is a once in a generation opportunity to change the kidney care paradigm in this country,” Culleton said.
Ibrahim urged the field of nephrology to make the most of this opportunity by demanding government and public support, and by revamping nephrology training, reimbursement, and career paths in the field.
“Together we must demand attention,” Ibrahim said. “We must advocate for kidney health. By thriving as a meaningful specialty, nephrology will extend the lives and quality of life for millions who otherwise will continue to die prematurely and unnecessarily, unjustly, inequitably.”
