Answer: None of the physicians, legislators or patients who in 1971 created the landscape for universal access to therapy for end stage renal failure, could have imagined that within 35 years more than 100,000 new patients would begin treatment for kidney failure in the United States every year. Neither could they have foreseen the remarkable quality of care that is now routinely delivered to dialysis and transplant patients across the country. Today, each person with kidney failure is entitled to benefit from the evolutionary improvements in these fields, but should alsocomprehend the extraordinary advances achieved in these 35 years, now taken for granted.

Imagine first hearing that your kidneys are failing and your survival will depend on dialysis or a kidney transplant. In fact, many of you have already experienced such a moment. But now try to understand the plight of those patients in 1971 who also learned that the only therapies capable of prolonging life, (dialysis and transplantation) were available only to 1 in 5 patients. Centers were scarce and had inadequate dialysis slots to offer, forcing committees to choose which patients would be offered therapy. Diabetes, being over 50 years old, or failure to perform a productive societal task, were among the reasons that patients were not selected to receive these therapies, and died. This was the reality in 1971. In contrast, today, it is the patient who chooses to live by agreeing to undergo dialysis or transplantation, both of which have become standards of care.

Over the 35 ensuing years, the spectrum of people requiring therapy for kidney failure has changed dramatically. Once expected to be of benefit predominantly for the youngest, least medically complex patients, both dialysis and transplantation are now known to be effective and appropriate for many groups of patients who live longer, better quality lives than were expected. For example, while diabetics were initially excluded, they now represent approximately half of all kidney failure patients. Other types of patients routinely treated today include patients in their eighth and ninth decades of life and those with HIV. As the composition of the renal failure population has changed, allied resources such as transportation to dialysis sessions and visiting nurse services for home care have also evolved.

With explosive growth in the number of patients receiving treatment there has also been responsive development of an infrastructure underlying the care and utilization of resources. In 1977, the Department of Health and Human Services created the ESRD Networks to focus on organizational activities, health planning tasks and medical review activities for the then 40,000 dialysis patients receiving care in 600 facilities. Today, 18 networks serve 300,000 patients and 4,500 facilities conducting activities that range from management of complaints and grievances, to quality improvement and dissemination of community information. Through them, the government keeps track of dialysis care. Through a different organization, The United Network for Organ Sharing (UNOS), it tracks the quality and accessibility of transplant care.

Not surprisingly, the expansion of kidney failure therapy attracted corporate interest. From a limited number of individual dialysis settings, the field has become dominated by a handful of large corporate providers who own multiple sites and direct care through centralized mechanisms. With sufficient resources to develop educational materials, and establish quality control programs, the benefits of corporate muscle in advocating for better patient care may be substantial. Certainly, a great degree of standardization has been achieved.

Where dialysis and transplantation were once experimental therapies, they have been progressively refined to an extent to provide ample evidence now used to guide both patients and providers in analyzing how well they each are doing. The ESRD Program has served as an excellent model for the nation’s growing focus on improving the quality and safety of patient care. Based on evidence developed in treating large numbers of similar patients, multiple indicators of quality (because they are predictive of survival) are routinely used to determine how adequate the kidney patient’s care is. Providers are now required to measure, collect and report data regarding how effective a patient’s dialysis is (through the urea reduction ratio (URR)), how well the anemia is being treated (by measuring hemoglobin), how well nourished the patient is, what type of vascular access is being utilized, whether the patient has been referred for transplantation, whether the patient has been placed on the kidney waiting list, how long kidney transplants function, and how many years patients survive with transplants, among other variables. In fact, data measurement and reporting have become so complex that providers are finding the challenge of meeting the regulatory requirements increasingly burdensome, not because it is unimportant, but because of financial limitations. Patients can and should strive to know how they “measure up” with these tools, and how their own care can be optimized according to national standards and expectations.

It is widely appreciated that many exciting and important medical advances have occurred during the past 35 years. Many of these have had direct impact on the lives of kidney patients. One of the most important is the availability of supplemental erythropoietin. With kidney failure, the body’s intrinsic production of the hormone erythropoietin is often inadequate and red blood cell production by the bone marrow is inadequate. Without its replacement, patients previously required serial blood transfusions, and many were chronically severely anemicwith resulting stress on the heart. Today, this deficiency is usually simply treated through injections of erythropoietin. The bone disease that used to cripple many kidney failure patients has become progressively more manageable as improved phosphate binders, drugs to reverse the bone loss of osteoporosis and drugs to suppress overactive parathyroid glands have become available. For those seeking transplantation, there have been truly revolutionary advances in the number and efficacy of drugs available to suppress the immune system. With improved ability to prevent rejection from occurring, there is no longer a need to limit possible kidney donors solely to close relatives. The direct benefit has been growth in the number of living unrelated donors whose organs successfully become “Gifts of Life.”

Overall, kidney failure therapy has improved dramatically since Shep Glazer’s historic dialysis treatment before the House Ways and Means Committee in 1971. Like pioneers in the Wild West, he and other courageouspatients received treatment from cowboy providers who did their best to manage complex problems, with inadequate support and resources from the medical and political establishment. Thanks to their groundwork, and to steady medical progress, today’s patients benefit from an integrated, system of care that provides choice, stability, quality and compassion. While the limitations of dialysis and the severe shortage of transplant organs remain important challenges, this work in progress has come far from where it began. Surely, the ongoing commitment to quality improvement, and to providing care for all who can benefit, will continue to make the next 35 years even better for the expanding population of ESRD patients.

Amy L. Friedman, MD, is an associate professor at Yale University School of Medicine , Department of Surgery in New Haven, Conn., and serves on the AAKP National Board of Directors and AAKP Medical Advisory Board.

This article originally appeared in the Special Edition 2006 aakpRENALIFE, Vol. 22, No. 2.