The Early History of Dialysis for Chronic Renal Failure in the United States: A View From Seattle

The Clinical Story 

On March 9, 1960, when Clyde Shields, a Boeing machinist dying from chronic renal failure, started on HD at University Hospital in Seattle, Scribner was unaware of 2 things: shunting of cannulas had been attempted before,7 and Teflon (polytetrafluoroethylene or PTFE) had non-stick properties. His idea was for an external shunt connecting cannulas in the radial artery and a forearm vein between dialyses to enable repeated treatments for patients with chronic renal failure. Teflon tubing had recently become available and a cardiovascular surgeon told him it was being used around pacemaker wires because it was well tolerated by tissues and referred him to Wayne Quinton in the hospital instrument shop. Quinton developed the technique for using heat to bend Teflon tubing to make cannulas to fit the patient’s anatomy and the u-shaped piece of tubing to connect them between dialyses. David Dillard, a pediatric cardiac surgeon, inserted the shunt in Clyde. This first dialysis lasted 76 hours using twin Skeggs-Leonards dialyzers, a blood flow of 100-130 mL/min, and a continuous flow of dialysate from a Sears-Roebuck freezer holding 300 liters of dialysate at 0°C, a technique developed originally for treating acute renal failure patients (Fig 1).8 Thus began one of the most important medical advances of the 20th century.

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Figure 1. Hemodialysis for chronic renal failure. Note the Skeggs-Leonards dialyzers and the chest-type freezer behind Clyde and the heparin pump borrowed from the Physiology Department. Reproduced from Scribner,15 with permission of National Kidney Foundation, © 1990.

Clyde’s treatments proved so successful that in April Scribner took him, his wife Emmie, and Quinton to the ASAIO annual meeting in Atlantic City. Because Clyde’s first dialysis was in March, it was too late to submit a paper reporting this new treatment for inclusion in the program. Consequently, Scribner showed Clyde to Kolff, Merrill, Schreiner, and a few others at private meetings where Quinton showed them how to bend Teflon tubing to make a shunt. Schreiner, editor of the ASAIO Transactions, was so impressed that for the only time in the Society’s history he published a paper that had not been presented at the meeting. This paper describing intermittent dialysis became one of the most frequently referenced papers in nephrology9and was accompanied by a paper describing the shunt (Fig 2).10

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Figure 2. Clyde’s Teflon shunt after 4 weeks in place. It is attached to a stainless steel arm plate with a plastic protective cover over it. The couplings are two modified “Swagelok” plumbing reducing unions with stainless steel bodies and nylon caps and ferrules. Reproduced from Quinton et al10 with permission of Lippincott Williams & Wilkins.

Three more patients started treatment in March, April, and June, respectively. The last of these, a 48-year-old man with polycystic disease, severe hypertension, and angina, died within months from cardiac causes.11 Ten years later the first 3 patients were guests of honor at a 10th anniversary celebration of long-term dialysis. Subsequently, Clyde died from a myocardial infarct after 11 years on dialysis, the second patient received a related donor transplant in 1968 and died from a myocardial infarct on the golf course 28 years after starting dialysis, and the third patient also died from cardiac causes after 14 years on dialysis. The treatment obviously worked. Ironically, even though hypertension was an obvious complication, the risk of cardiovascular disease was not clearly recognized until a 1971 report from the National Dialysis Registry12 and a 1974 paper from Seattle.13

In 1961, Scribner visited Copenhagen, where Claus Brun showed him a large flat plate dialyzer developed by a Norwegian urologist, Fred Kiil. Because of low internal resistance it could be used without a blood pump and was intended for use with the new cellulosic membrane Cuprophane.14 Scribner saw its potential immediately and brought one back to Seattle in the coat closet of an early PanAm polar flight. A friend at the Western Gear Corporation then worked out how to mill Kiil boards with a flat surface and uniform blood film thickness from polypropylene slabs,15 and the Kiil became the mainstay of the Seattle program for more than 10 years until superseded by the hollow fiber dialyzer.16 Even so, Merrill, Kolff, and many others preferred using twin-coil dialyzers through the 1960s.17, 18

Because movement of the rigid Teflon shunt was transmitted to the tips, damaging the vessel intima, Quinton developed a less rigid shunt using silastic tubing with Teflon tips. Initially, clotting in silastic tubing was a problem, but by 1962 Quinton could extrude silastic tubing smooth enough not to cause clotting, which improved cannula longevity.19 Also that year, Hickman and Scribner first used the shunt and a single 4-layer Skeggs–Leonards dialyzer to treat infants and small children, a much simpler and safer technique than using twin coil dialysis.20

In 1962, Cimino and Brescia reported on veno-venous access for HD which used a sphygmomanometer to dilate an accessible forearm vein and a blood pump, and in which blood was returned through another vein, usually in the ankle.21 This experience led them to make one of the most important developments in HD — the arteriovenous fistula.22 Even though this required a blood pump for dialysis, the blood access problem was solved and use of the shunt declined rapidly. Six years later Kolff and colleagues described a single–needle device for HD.23

In 1961, because 3 of the original patients had survived for a year, Scribner asked University of Washington Hospital administration about starting more patients. They refused, concerned that if his NIH funding ever dried up, the state of Washington would have no choice but to continue to support the patients. Scribner then approached James Haviland, President of the King County Medical Society, to enlist community support. With Haviland’s help and a grant from the Hartford Foundation, the world’s first out-of-hospital non-profit community outpatient dialysis center was established in the basement of the Swedish Hospital nurses’ residence.24 On January 1, 1962, the 3-bed Seattle Artificial Kidney Center (SAKC) opened with nurses providing overnight dialysis twice weekly using Kiil dialyzers and cooled dialysate from tanks made by Sweden Freezer, a local soft ice-cream machine manufacturer.25

Because of money and space limitations, the SAKC established an anonymous Admissions and Policy Committee to review and select from potential patients. This committee had 6 lay members who were community leaders drawn from various walks of life and 1 physician member who was not a nephrologist. Patients were screened by a panel of nephrologists to see they met stringent medical criteria before referral to the committee. They had to be stable, emotionally mature, uremic adults under the age of 45, without long-standing hypertension and vascular complications, willing to cooperate with the dialysis regimen and the low protein/low sodium dietary regimen, and with stable or slowly deteriorating renal function. Children and young adults who were not potentially self-supporting were excluded. During the first 13 months of operation the committee reviewed 30 candidates, 17 of whom were judged medically suitable; 10 of these were selected for dialysis, and the remaining 7 died.26

The committee was made famous in an article by Shana Alexander in Life magazine later in the year (Fig 3).27 This along with a 1965 NBC documentary entitled “Who Shall Live?” sparked criticism and much discussion of ethical issues involved in patient selection28, 29, 30, 31, 32, 33 and has been described as the origin of bioethics as a discipline.34 John Darrah, who chaired the committee, has commented on his experiences.35 Scribner, in his 1964 ASAIO presidential address, discussed ethics in dialysis, transplantation, and medicine generally; his comments are just as pertinent 43 years later.36

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Figure 3. The Seattle Artificial Kidney Center Admissions and Policy Committee, in a photograph taken by Lawrence Schiller for Life magazine27 (image reproduced with permission, copyright © Polaris Communications, Inc.).

In 1970, a report on 8 years’ experience at the SAKC, now renamed the Northwest Kidney Center (NKC), included details of the center’s operation and the first 175 patients. Overall patient survival was 90% at 1 year, 85% at 2 years, and 61% at 5 years, but in patients aged 56 or older, 2-year survival was only 40%.37

Interest in home HD began in Boston, Seattle, and London in 1963. Home HD was first suggested by Charles Kirby, a vascular surgeon, in his 1961 ASAIO presidential address: “Perhaps what we need is a home dialysis unit to be placed by the patient’s bedside, so that he can plug himself in for an 8-hour period once or twice a week.”38 By early 1964, Merrill’s group in Boston was using twin-coil dialyzers in the home, 5 hours twice a week, in 4 male patients assisted by their wives and occasionally attended by a physician or nurse.39

Meanwhile, in Seattle, Scribner began a fruitful relationship in 1963 with Les Babb, Professor of Nuclear Engineering at the University of Washington. This led to the first use of proportioning pumps to make dialysate from concentrates in a system serving 4 dialysis stations at University Hospital.40 The concentrate contained sodium acetate rather than bicarbonate or lactate41 to prevent precipitation and allow continuous production of dialysate. Acetate concentrate became used routinely until, with bigger dialyzers and shorter dialysis, it could not be metabolized fast enough to prevent accumulation and the appearance of toxic effects.42

When the 15-year-old daughter of one of Babb’s friends was turned down by the SAKC, he and his staff rushed to make a single-patient version of the proportioning system with built-in monitoring and fail-safe devices designed for patient use at home. This was the prototype for almost all single-patient dialysis machines in use today. Based on their experience, the group described the safety aspects of HD.43 The patient and her mother were trained to do dialysis using this machine, a shunt, and a low-resistance Kiil dialyzer. Caroline dialyzed for 4 years at home (Fig 4) while completing high school and for 2 years while at college before dying from a complication of systemic lupus erythematosus.

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Figure 4. The first Seattle home hemodialysis patient. Note the machine and the Kiil dialyzer.

In 1960, the original Seattle patients dialyzed once every 5 to 7 days when symptoms of uremia redeveloped. This was soon changed to 12 to 20 hours twice weekly when severe hypertension and peripheral neuropathy began to appear.11 The first home patients dialyzed twice weekly for long hours in the afternoon and evening, but they were changed to thrice weekly dialysis for convenience. Shaldon, in London, was the first to use overnight home HD in October 1964,44, 45 and Seattle adopted a similar schedule of 6 to 8 hours overnight thrice weekly after he visited there in December. Shortly thereafter, Seattle instituted thrice weekly dialysis for almost all patients, and by 1973 this had become the usual practice in the United States.46 Reports on the Seattle home HD program were published in 1964 and 1966,47, 48 and Merrill’s group described their further experience with home HD in 1965.49 Because assembling a Kiil dialyzer for every dialysis was burdensome, a technique was developed for storage and reuse, modified from the one devised by Shaldon for coil dialyzers. This allowed patients to rebuild the dialyzer only once every 2 weeks.50 In 1965, the University of Washington instituted a remote program that trained 52 patients from elsewhere in the United States and Chile, Malaysia, the Philippines, and the Sudan to do home HD successfully.51

In 1966, the SAKC also started a home HD program because the advantages were clear, particularly the opportunity for rehabilitation and the lower ongoing costs after training, which were less than half the costs of center HD.52, 53 The savings allowed many more patients to be treated and so in 1967 the SAKC and the Spokane Kidney Center instituted a policy that all Washington State patients should be transplanted or go home. The successful rehabilitation of most home patients so impressed the State Division of Vocational Rehabilitation that they provided funding for equipment and patient supplies, with the result that patient selection soon became unnecessary. By 1972, 90% of the 130 NKC patients were dialyzing at home, but this was a time when few older patients and very few diabetics were treated.54

In 1959, Richard Ruben in San Francisco was the first to use peritoneal dialysis (PD) successfully for a patient with chronic renal failure who survived for 6 months.55 Two years later, Fred Boen, author of a classic monograph on PD,56 was invited to Seattle to establish a long-term PD program. The following year he described the first automatic cycling PD machine, developed from a system previously used in studies on gastrodialysis, and an indwelling peritoneal access fitting.57 Elsewhere, others were working on indwelling and other access devices.58, 59, 60 In 1964, Boen’s group described 2 patients successfully treated for 2 years and for 11 months, respectively, using a new automatic cycler and repeated punctures for peritoneal access,61 and the following year they reported 1 year’s experience with home PD (Fig 5).62

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Figure 5. The first Seattle home peritoneal dialysis patient using 40-liter glass carboys to hold the sterile dialysate and the dialysate outflow.

Henry Tenckhoff joined Boen in 1964 and took over the program when Boen returned to the Netherlands. The most far-reaching development came in 1968 with the indwelling peritoneal catheter that became known as the Tenckhoff catheter.63 Tenckhoff was also interested in developing better automated PD equipment. In 1969, his team reviewed water purification, bacteriology, sterilization, and dialysate preparation with a prototype home peritoneal dialysate delivery system using a 316-liter stainless steel boiler tank. This was later developed commercially by COBE laboratories.64

In 1970, Tenckhoff and Curtis reported on 19 patients treated by self-PD for up to 4 years, 16 of them at home. There were 16 episodes of peritonitis, an incidence of 0.59% of all dialyses, and 3 deaths. PD was seen as a good alternative for patients living alone, children, and patients with cardiac disease.65 Shortly thereafter, its use in 12 children aged between 2 years 10 months and 15 years 9 months was reported, showing PD was well accepted by children of all ages and their parents.66

In 1972, Tenckoff’s team reported the first automatic peritoneal system using reverse osmosis to sterilize dialysate. This was simple, relatively low cost, and delivered a continuous supply of sterile pyrogen-free dialysate from tap water and sterile concentrate.67 It was developed commercially by the Physiocontrol Company, but PD was revolutionized in 1976 by the development of continuous ambulatory peritoneal dialysis.68

In 1966, physicians at the Peter Bent Brigham hospital in Boston were faced with a problem similar to that faced by Scribner 5 years earlier. The hospital refused to expand dialysis capacity despite increasing numbers of patients and a rapidly growing transplant program. An opportunity arose to establish an out-of-hospital dialysis unit in a nearby extended care facility, but, unlike the community-supported, non-profit SAKC, this became a for-profit venture. Further expansion required raising capital and led to the formation of National Medical Care in 1968. With the Medicare ESRD Program expanding rapidly, this company grew to become the dominant provider of dialysis in the United States.69

In 1965, Maher and Schreiner published an important paper dealing with the then recognized complications of dialysis.70 Serum hepatitis started appearing in dialysis units around the same time, resulting in deaths among both patients and staff. Outbreaks occurred at the NKC,71 Downstate Medical Center in Brooklyn,72 and many other units. Awareness of this infectious risk led to adoption of precautions, and when Australia antigen screening became available in 1965, the epidemiology of the problem became better understood.73 Even so, it was a number of years before isolation and other precautions, identification of carriers, and development of a vaccine against hepatitis B virtually eliminated this problem.

Clyde developed malignant hypertension very early in 1960, and this was controlled by changing to 2 long dialyses a week. Experience showed it related to volume and could usually be controlled with ultrafiltration and dietary sodium restriction, thus avoiding use of the crude antihypertensive agents then available.74 This experience led to the concept of dry weight.75 In addition to the effects of hypertension on the cardiovascular system, Bagdade and colleagues at the Seattle Veterans Administration (VA) were among the first to recognize hypertriglyceridemia in dialysis patients.76

In the mid-1960s, mechanisms surrounding anemia in dialysis patients were being unraveled, and Eschbach and Adamson recognized that repeated transfusions merely depressed the bone marrow, resulted in iron overload, and perpetuated the need for further transfusions. As a result of their studies, patients in Seattle were not transfused except for major blood loss, given iron only as needed, and generally maintained a hematocrit in the mid-20s,77, 78 but many other US programs continued to transfuse patients.

After a few months on dialysis, Clyde developed gout-like attacks that responded to colchicine and were relieved by longer dialyses.79 He and other patients also developed mysterious lumps in soft tissues around their shoulders and elsewhere. These were metastatic calcifications caused by serum phosphate levels in the 10-14 mg/dL range. A gastroenterologist pointed out that an undesirable complication of antacid therapy was phosphate depletion, and with oral aluminum hydroxide as phosphate binder the deposits melted away. It was more than 10 years before the risk of aluminum toxicity was recognized.

Eventually, the patients developed renal bone disease which, as was soon realized, related to vitamin D resistance and hyperparathyroidism, often requiring parathyroidectomy.80, 81 It was not until the early 1970s that vitamin D compounds became available and the complexities of calcium and phosphate metabolism in dialysis patients could be better handled.

Clyde developed uremic peripheral neuropathy in the summer of 1960 and this was slowly arrested by increased hours of dialysis.15 The second patient, who still had some renal function, did not develop neuropathy, the first recognition of the importance of residual renal function.15 A 1967 review of the Seattle experience confirmed neuropathy could be prevented, arrested, or ameliorated with more intense dialysis82 and noted that adequate dialysis was defined in 1964 as that amount necessary to prevent or arrest uremic neuropathy.83 In the late 1960s, many programs were still dialyzing 4 to 6 hours twice weekly with coil dialyzers, and we thought such patients did not appear as well as those treated with Kiil dialyzers thrice weekly for 6 to 8 hours. In 1971, authors of a paper about reversal of uremic neuropathy following transplantation noted that in their experience, “dialysis with a Kolff twin-coil twice a week is associated with a high prevalence of uremic neuropathy which fails to improve if such a program is continued.”84 De Palma responded that patients weighing 60 kg or more dialyzed with coil dialyzers needed at least 9 hours of dialysis twice weekly, preferably 6 hours thrice weekly, to reduce the risk of developing neuropathy.85 He defined adequate dialysis as “the amount of dialysis time per week that permits the patients to be rehabilitated, eat a reasonable diet (as far as protein and calories), make blood, maintain a near normal blood pressure and prevent the progression of peripheral neuropathy.”

Since 1965, Scribner had believed so-called middle molecules were important toxins and that peripheral neuropathy was rare in PD patients, despite higher BUN (blood urea nitrogen) and creatinine levels, because the peritoneal membrane was more permeable to larger molecules than cellophane.86 He also noted that prevention of peripheral neuropathy in HD patients depended more on longer hours of slow dialysis than on BUN and creatinine levels. This led to the square meter-hour hypothesis relating middle molecule clearance and adequacy to dialyzer surface area and hours of dialysis.87 Babb and Scribner went on to develop the dialysis index that took into account body surface area, residual renal function, vitamin B12 clearance, the membrane, and ultrafiltration as a measure of dialysis adequacy,88 but development of the concept of Kt/V eclipsed this index method in the 1980s. A perspective on the middle molecule hypothesis was published in 1981.89

Among other technical innovations, in 1967 Lee Henderson and colleagues published their first report of laboratory tests on new synthetic membranes for diafiltration.90 This was followed by animal and human studies,91, 92, 93 leading to the concept of convective clearance and eventually to the clinical use of hemodiafiltration, primarily in the acute setting in the United States. Because removal of middle molecules is greater, this may be the best form of dialysis for chronic renal failure as well.

Two other important technical developments came in 1969 from Maxwell’s group in Los Angeles. One was a report on animal studies with a sorbent-based system for dialysis using a cartridge containing zirconium phosphate, activated carbon and hydrated zirconium oxide.94 Soon to follow was the development of the REDY System, a portable HD device developed in the early 1970s.95, 96 This had some problems and was not widely used in the United States except for trips by home patients.

The second development was the first report on more frequent “daily” dialysis describing several patients dialyzing at home 5 times weekly with a coil dialyzer.97 This continued until the Medicare ESRD Program began and then ceased because it was no longer financially feasible. Patient benefits were just as striking as those that have been reported recently following the reintroduction of more frequent dialysis.

Robin Eady, the world’s longest surviving ESRD patient (25 years on dialysis, mostly at home, and 19 years with a transplant) has published an excellent patient’s view of the early history of dialysis.98

The Political Story 

In October 1962, Shana Alexander’s article27 in Life describing long-term dialysis at the University of Washington and the SAKC was about to go to press. Just before its publication, the Deputy Surgeon General warned the Secretary of Health, Education and Welfare (HEW) that “strong pressure for some Federal action” might be anticipated.99 This did not materialize, but White House staff asked HEW about the issue following a Wall Street Journal article in August 1963 on the “tormenting question facing health officials, doctors and legislators: ‘How much is a human life worth?’”.100 The response was that no funds were earmarked for this purpose but there were other possible sources of some support.101 Again no action was taken.

The first government response to developments in dialysis occurred in 1963 when the VA announced it would establish 30 dialysis units in VA hospitals across the country to treat eligible veteran beneficiaries. Around the same time, the Public Health Service (PHS) provided a grant from chronic disease funds to help support the SAKC and awarded a similar grant to Downstate Medical Center in Brooklyn in 1964. That same year, Congress established a Transplant Immunology Program in the National Institute of Allergy and Infectious Diseases and in 1965, following the advocacy of Scribner and others, established the Artificial Kidney-Chronic Uremia Program in the National Institute of Arthritis and Metabolic Diseases. For the next 12 years, this program provided most of the funding for clinical research in dialysis and its complications and hosted an annual meeting attended by most of the physicians interested in dialysis. In addition to these 2 NIH-based research programs, the PHS established a demonstration grant program in 1965 to examine the feasibility of providing dialysis on a larger scale and created the Kidney Disease Control Program (KDCP) of the Regional Medical Programs Service (RMPS) to oversee this effort.

Congressman John Fogarty (a Democrat [D] from Rhode Island), chairman of the House subcommittee that appropriated funding for HEW, visited Seattle in November 1965 to see a patient dialyzing at home. He returned to Washington expressing support for a home dialysis policy.

The major political development of 1966 was appointment by the Bureau of the Budget of a committee of experts to advise on federal efforts to deal with dialysis and transplantation nationally. This Committee on Chronic Kidney Disease (the Gottschalk Committee) met for 2 years. In their report they stated that dialysis and transplantation were no longer experimental procedures and recommended establishment of a national treatment program to be funded by Title XVIII – Medicare.102 However, the report was not widely disseminated and the Bureau of the Budget took no action “because we had a little war going on in Southeast Asia.”

Through 1965 and 1966, the KDCP awarded ten 3-year grants to establish demonstration centers to show that dialysis was effective and to encourage local and other support for when the grants ran out rather than involve government in funding direct patient care. However, by late 1966, home dialysis was becoming established as an alternative to center dialysis, and Scribner and others forcefully urged the KDCP to change its support from centers to home dialysis. As a result, fourteen 5-year contracts were awarded in 1966 and 1967 to demonstrate the effectiveness of training patients and families to dialyze at home. The Gottschalk report was released in November 1967; among its conclusions was that kidney transplantation was preferable to dialysis and home dialysis was preferable to center dialysis.102 In addition, the Bureau of the Budget pressured the VA and PHS to increase the use of home dialysis. The overall effect of these changes was that, by January 1972, 40% of the 4,953 US dialysis patients were on home dialysis.103

In 1965, Senator Henry Jackson (D, Washington) introduced the first bill to finance treatment by dialysis and transplantation because a friend of his from grammar school, Kay Sloane, had become one of Scribner’s patients. She started dialysis in 1967 and lived for 10 years, and Jackson continued to introduce legislation in subsequent sessions of Congress until passage of the 1972 legislation. Others who consistently sponsored kidney legislation included Senator John Tower (a Republication from Texas) and Congressman Edward Roybal (D, California), but no Congressional hearings were held on kidney disease until 1970, when the Heart Disease, Cancer, and Stroke Amendments of 1965 were amended to add “and Kidney Disease.”

In 1969, George Schreiner became President of the National Kidney Foundation (NKF) and hired Charles Plante as the organization’s Washington representative. This was at a time when the groundswell to provide some government support for kidney patients was increasing. The Congressional scene was very different then; there were many fewer staffers and these were very influential, worked closely with the executive branch, and had close ties with the Social Security Administration’s (SSA) Bureau of Health Insurance (BHI). Committee chairmen drove legislation and appropriations and Wilbur Mills (D, Arkansas), Chairman of Ways and Means, was the most powerful House member because all measures affecting tax, Social Security, and Medicare originated in his committee and emerged to the floor as bipartisan bills.

In 1971, serious policy debates focusing on national health insurance were underway in both Congress and the White House. By that summer, H.R. 1, dealing with Social Security, Medicare, and welfare reform, including extending Medicare coverage to the disabled, had passed out of committee and possible amendments were being discussed in both the House and Senate. The Ways and Means Committee had a tradition of allowing interested persons to address the committee and so in a hearing on national health insurance on November 4, several patients from the National Association of Patients on Hemodialysis (NAPH) spoke, including Shep Glazer, NAPH Vice President.104 Glazer also dialyzed briefly before the committee, although the committee staff, NKF, and Schreiner had not encouraged this because of fear about a possible accident occurring in front of the committee. Schreiner had tried to dissuade Glazer and was astonished when called the evening before the hearing and asked to provide a dialysis machine from Georgetown. This was done reluctantly. The NKF did not want Schreiner to attend the hearing and so a nephrology fellow, James Carey, was sent as attending physician with instructions that if anything untoward happened he should turn the machine off, clamp the blood lines and declare the dialysis over. Later, Carey told Schreiner that Glazer developed an arrhythmia and so dialysis lasted only long enough to fill the lines before they were clamped. Only a few committee members were present, still thinking more about national health insurance than kidney disease, and a parent of a hemophiliac child made a greater impression on them. The hearing record refers to a dialysis machine being present but makes no mention of an actual dialysis. Nevertheless, the press was impressed and reported the dramatic dialysis widely. As a result, many patients and others came to believe this dialysis was the major stimulus leading to the Medicare ESRD Program. More important was that a week later, Schreiner and William Flanigan from the University of Arkansas in Little Rock, home of Wilbur Mills, testified before the committee on behalf of the NKF.105 On December 6, Mills introduced H.R. 12043, a bill to amend the Social Security Act to provide financing for patients with chronic kidney disease. This would be through a budgeted program, not an entitlement, and would assist patients in financial need, establish centers that would make home dialysis equipment available, train personnel, and provide education about chronic kidney disease.

Early in 1972, Plante, Schreiner, and others from the NKF met with Senate Finance Committee Chairman Russell Long (D, Louisiana) and Senator Herman Talmadge (D, Georgia) chairman of the Health Subcommittee to brief them, and Plante met with Senator Vance Hartke (D, Indiana), a supporter of the NKF’s agenda. On February 22, Hartke and Senator Alan Cranston (D, California) introduced S. 3210, a bill to amend the Public Health Services Act to help develop programs for treating chronic kidney disease and provide financial help to patients.

Through the summer, Plante continued contacts with committee staffers while they discussed a possible kidney disease amendment in H.R. 1. Among Finance Committee staff, James Mongan, a physician, argued persuasively that an amendment to this effect should be included because chronic kidney failure was the only situation where money separated individuals from life or death and that it would also serve as a pilot for catastrophic health insurance. On September 26, the Finance Committee reported out H.R. 1, agreeing with many of the health-related provisions, including extension of Medicare coverage to disabled beneficiaries, and adding 49 provisions of their own. There was no kidney disease provision, but Senator Hartke inserted a brief statement discussing kidney disease.

The bill came to the Senate floor in the last week in September, and on Saturday, September 30, Hartke introduced his amendment to establish Medicare entitlement for patients needing dialysis or transplantation. Debate lasted about 30 minutes and the amendment passed by 52 votes to 3, with 45 Senators absent.

The Joint House-Senate Conference Committee met in mid-October and although the kidney provision was not in the House bill, this amendment was discussed briefly. The Hartke amendment included a 6-month waiting period before entitlement and the House proposed shortening this to 3 months. The committee accepted this and Section 299I was included in H.R. 1, the Social Security Amendments of 1972, and was adopted by both House and Senate. President Nixon signed the bill on October 30, 1972.

Estimates of the cost of the kidney provision were wildly off. According to the NKF, the cost would be $35 to $75 million the first year; the SSA Office of the Actuary, which had had little time to come up with figures, estimated $100 to $500 million the first year, increasing substantially in succeeding years. Scribner, Samuel Kountz, a University of California transplant surgeon, and others had provided the low estimates Hartke quoted: $22,000 to $25,000 per year for hospital dialysis, $17,000 to $20,000 for center dialysis, $19,000 for the first year of home dialysis with a subsequent cost of about $5,000 per year, 85% success rate for kidney transplants, and a substantial future reduction in the $15,000 cost of a transplant. Hartke also expected that costs would continue to fall with technological advances and more transplants. Reflecting on what he had heard from the enthusiasts, Hartke noted that “60% of those on dialysis can return to work but require retraining and most of the remaining 40% require no retraining whatsoever. These are people who can be active and productive, but only if they have the lifesaving treatment they need so badly.”

In January 1973, controversy between the Office of the Assistant Secretary of Health, the Bureau of Health Insurance and the Democratic Congress surfaced in a front-page New York Times article on the projected millions of dollars in excess costs106 and in an editorial entitled “Medicarelessness”107 that was criticized by the NKF.108 Rettig has noted that “the political damage created by this challenge affected supporters of the legislation and stalked the program for years to come.”

Since the Medicare ESRD Program began on July 1, 1973, there have been many clinical and related developments that are beyond the scope of this review, and many political and administrative changes that have been documented by Rettig, Nissenson,4, 5, 109 and others. Some 30 years ago, Scribner (Fig 6) summed up the early years of dialysis for chronic renal failure as “a noble experiment.” Later he became increasingly concerned about the care provided to patients in the United States as dialysis became an industry dominated by for-profit organizations.

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Figure 6. Belding Scribner. Photo courtesy of Eli Friedman.