By Professor Robert Girling, Adjunct Professor of Socially Responsible Business at Mills College
Over half a million Americans are currently being kept alive by dialysis machines that make them virtual captives for hours at a time each day. Meanwhile over 120,000 patients are waiting for a transplant but only about 17,000 kidneys are available each year from donors and accident victims. As a consequence thousands of patients die each year on dialysis while waiting for a transplant.
Now a team of medical researchers at UCSF could soon be on the verge of setting them free and vastly improving their lives.
UCSF researcher Dr. Shuvo Roy and his team are currently testing an implantable artificial kidney designed to filter the blood and perform other kidney functions.
Kidney disease is a major challenge for health care systems around the world. The costs of treatment are absorbing an increasing share of government health budgets in the US and around the world. Treatment with dialysis or kidney transplantation creates a huge financial burden for the people who need it.
Many people cannot afford treatment at all, resulting in the death of over 1 million people annually in 112 countries. In the US, treatment of chronic kidney disease is likely to exceed $48 billion per year. In Mexico, chronic kidney disease is the most expensive of chronic diseases which absorb 22% of the Mexican Social Security Institute (IMSS) budget. And the epidemic of diabetes which affects so many poor people is adding tens of thousands more each year.
The bio-artificial kidney, also known as the iRAD, is being developed by Dr. Shuvo Roy of UCSF and Dr. William Fissell of Vanderbilt University. The iRAD is designed to be implanted near the patient’s own kidneys and permanently connected internally to the patient’s blood supply and bladder.
Along with Roy at UCSF and Fissell at Vanderbilt, a national team of scientists and engineers at universities and research centers are working toward making the iRAD available to end-stage renal disease patients. In September 2015, the project was designated for inclusion in the FDA’s new Expedited Access Pathway program to speed development, evaluation, and review of medical devices that meet major unmet needs in fighting life-threatening or irreversibly debilitating diseases.
The iRAD is the size of a coffee cup and consists of two modules that work together to rid the patient’s blood of waste products. First, a hemofilter module processes incoming blood to create a watery ultrafiltrate that contains dissolved toxins as well as sugars and salts. Second, a bioreactor of human kidney cells processes the ultrafiltrate and sends the sugars and salts back into the blood. In the process, water is also reabsorbed back into the body, concentrating the ultrafiltrate into “urine,” which will be directed to the bladder for excretion.
The results to date are so promising that the UCSF team received a major boost in the form of a grant from the National Institutes of Health to help move the artificial kidney towards human testing. Dr. Roy expects that with adequate support, the artificial kidney could be available as early as 2020.
I have been working with Dr. Roy to evaluate the costs and benefits associated with the conventional treatments and compare them with the estimated costs and benefits attributable to the bio-artificial kidney. This will provide an estimate of the savings to Medicare, insurers and HMOs that would result from the development and application of this emergent medical device.
Our findings indicate that substantial savings could redound to patients, Medicare, HMOs, and other health care payers from the bio-artificial kidney. If the 120,000 patients currently on dialysis and waiting for a transplant were to receive a bio-artificial kidney, Medicare could save as much as $5 billion each year. These savings would be in addition to the patient benefits—an extended life span and the substantial improvement in the patients’ quality of life associated with the iRAD.
This study has important implications for policymakers. The budgetary savings to Medicare attributable to shifting treatment from costly hemodialysis and peritoneal dialysis for the ESRD population to the iRAD would be substantial. Dr. Roy and his team need an estimated $20 million to complete development and testing of the bio-artificial kidney and another $100 million to bring it to market. This investment would be recouped in the first two years by Medicare if as little as 2 percent or 2000 patients currently on the waiting list for a kidney transplant were to receive a bio-artificial kidney.
From a financial perspective The UCSF Kidney Project promises to save the US Government and Medicare billions of dollars annually.
And it would make kidneys available to the thousands of patients on the waiting list for a transplant at a fraction of the cost of present dialysis treatment.
This potential savings together with the promise of vastly improving the lives of those suffering from kidney failure is an investment that requires urgent attention.
Robert Girling is an Adjunct Professor in the CSB at Mills College. He has taught and consulted in 20 different countries including the Federal University of Bahia,Brazil; the World Bank, the Pan American Health Organization, and the International Center for Research on Women. Prof Girling is the author of over 50 articles and books including The Good Company (Hill Press, 2012).