HemoDoc, From Doctor to Patient

The Lasting Scribner Legacy: "The Ideal Patient"

In 1960, Belding Scribner awoke after a revealing dream with the remedy to vascular access for chronic renal failure with his vision of a teflon shunt. This provided the first feasible dialysis access and ended over 17 years of researchers frustration to expand acute dialysis care to patients with no hope of renal function recovery that we now call End Stage Renal Disease (ESRD). However, Dr. Scribner's legacy is much more than simply finding a workable dialysis access. Belding Scribner not only found a solution to long-term access, but through clinical judgement and humanitarian benevolence, he not only gave his innovation away to the entire world, but then opened his clinic for all to learn the clinical care of chronic renal patients. All of this was tempered with his caring and compassion to relieve suffering and restore and rehabilitate each patient. 

One of the most interesting stories of these early pioneering days of early chronic dialysis care, is that of Nils Alwall, the noted renal pioneer from Sweden. Alwall entered clinical studies after first completely pharmaceutical studies with an interest in pulmonary edema and developing an "ultrafiltration" machine that could alleviate the excess fluids. In doing so, he became aware of the ability to also remove uremic toxins creating an effective dialysis machine that also had sophisticated ultrafiltration controls. The initial design made of metal was heavy and difficult to move, and had difficulties with leakage. But it was a prototype that brought forth care of acute renal failure. In the next two decades beginning in the early 1940's, Nils Alwall treated over 1000 patients which was more than all the other researchers in the world combined. 

As news of the Scribner Teflon Shunt reverberated throughout the early nephrology/dialysis community, Nil's Alwall eagerly instituted use of the Scribner shunt in his clinic in Lund, Sweden. However, his first attempts with the Scribner shunt and chronic hemodialysis failed in Sweden as it did in many other parts of the world due to lack of understanding of chronic renal failure treatments. Many researchers flocked to Seattle to learn the details of the Scribner protocols and how to use his shunt continuously with effective dialysis. In a biographical memoir by one of his students, Nils Alwall quietly traveled to Seattle to see what "magic" Scribner possessed not by his excellent outcomes.

Nils Alwall -  A Personal Appreciation: J Stewart Cameron

"At the end of his 1963 book (10), Alwall presented depressing data on his early attempts to use the arteriovenous shunt to treat end-stage renal failure. All 10 patients had died quite early after starting long-term dialysis. This surprise was part of an experience noted worldwide, and many wondered what "magic" Scribner and his colleagues had concealed. Nils thus quietly went off to Seattle to work for some months himself there, to learn on site how to do long-term dialysis and found that meticulous attention to detail, the use of humpless dialysis with long sessions (6-8hr) and meticulous control of weight, salt and water intake and blood pressure were the main components of the "magic" (6). He returned and re-started a now successful program of long-term dialysis in Lund in 1964."

Seattle became the destination for researchers wishing to understand the clinical determinants of Scribner's success that extended far beyond the vascular access issues. The Seattle success emerged as the stimulus for acceptance of dialysis worldwide becoming a reliable and viable treatment of chronic renal failure. But, what Scribner and his team in Seattle accomplished was unattainable to many of the other researchers until they evaluated his entire approach. I believe that the Scribner legacy of success stemming from his very first patient, Clyde Shields, is attributed to Scribner's empiric clinical judgment that was coupled with his humanitarian benevolence. Scribner's motivation for developing the shunt is found in the poignant story of a patient from Spokane WA.

In early 1960, Dr Scribner encountered a patient who initially responded exceptionally well to several rounds of dialysis. However, when Dr. Scribner determined that the cause of this patient's renal disease was incurable and irreversible, he had no choice but to release him to a slow and agonizing death over the next three weeks. 

Our Back Pages: UW History with a Twist - Insomnia, Teflon and Lifesavers

At the time, dialysis only took place in an operating room. It preserved the life of patients with temporary kidney failure, keeping them alive until their own kidneys returned to normal. Glass tubes and to be inserted into a patient to connect them to the artificial kidney, and were removed when dialysis was done. Patients whose kidney did not recover soon died.

Scribner was haunted by the death of a Spokane patient who briefly made a dramatic recovery while on dialysis, and thought about the case constantly. I literally woke up in the middle of the night with the idea of how we could save these people, he recalls.

His idea: insert a Teflon tube in the patient's artery and vein, and keep access open by hooking the tubes together to create a high blood flow. During dialysis, the “shunt” would be pulled out and replaced by lines to the artificial kidney machine.

As Nils Alwall summarized, Scribner's success was a combination of the attention to detail, the pumpless kidney, and further attention to weight management, fluid, sodium and BP that made Scribner's approach successful. In all this, Dr. Scribner altruistically spread the news of his protocols and his devices to all who sought a remedy to chronic renal failure. In the end, it was Scribner's clinical judgement coupled with his humanitarian benevolence that made a difference in 1960 and still is what makes a difference in 2023. While main in the rest of the world pursued increased urea removal with faster and less frequent treatments, Belding Scribner understood that long, slow and more frequent dialysis schedules coupled with ultrafiltration and sodium reduction to control BP was the foundation of his program.

The WA state Department of Vocation and Rehabilitation enthusiastically embraced funding the Seattle program after observing fully rehabilitated patients. By the time of the 1973 Federal ESRD program, Northwest Kidney Center was able to accommodate almost all the patients in need of care and did so with over 90% with overnight home hemodialysis. All this extended from Scribner's simple, but powerful definition of dialysis adequacy:

"If the treatment of chronic uremia cannot fully rehabilitate the patient, the treatment is inadequate."

Beginning with Willem Kolff's focus on rapid removal of urea with less TIME and frequency of sessions, America continues to stagger under the burden of a sickly, hypertensive and costly ESRD population. Scribner had again predicted this after observing the destruction of the treatment standards of care of longer, slower and more frequent treatments capable of fully rehabilitating the patient.  Further, the Seattle program did this at 1/3rd the cost of the in-center program.

Today, it is as if the legacy of Scribner was completely forgotten after 1973 and they began define dialysis adequacy by a non-toxic, or not very toxic, small, water soluble and easily diffusible molecule, urea. Patients were divorced from the clinical assessments utilized by Scribner and additional treatments added when needed, and instead became sickly, hypertensive and disabled. This became the new standard of care and the long, slow and frequent standard of care between 1960 and 1972 has since become "controversial," and widely maligned.

Yet, through all of this, anyone who studies how to do dialysis according to the  Scribner approach can reproduce the same physiologic benefits that occurred in the Scribner era of 1060-1972. His approach is reproducible and fruitful rendering the rehabilitated existence I know well myself. Willem Kolff described what he called "the ideal patient."

Guide for treating patients by chronic dialysis with the twin-coil artificial kidney 

"The ideal patient is one who does not require removal of fluid and sodium during dialysis because he limits his fluid and sodium intake. Thus, his predialsyis and his postdialysis weight and blood pressure will be respectively similar or the same. This avoids the great changes between pre dialysis hypertension and postdialsyis hypotension and ill health. The blood pressure and weight changes are aggravated by the use of antihypertensive agents, particularly before dialysis, which tends to cause a grater fall in blood pressure after dialysis. Thus, antihypertensive agents should not be used if it is at all possible to avoid them."

I am grateful for the legacy of Belding Scribner in my own care and management. Fortunately, I have learned how to tolerate a very low sodium diet and to lengthen my sessions as much as the provider will accommodate. Belding Scribner's legacy is alive and well and can never be destroyed despite the concerted efforts of many to confuse, obfuscate, mystify and perplex patients and nephrologists through endless academic studies which are contrary to the clear achievements of Scribner and many other early dialysis pioneers. Scribner's legacy lives on in Australia, New Zealand, Japan and Europe, but it mostly lives on in every long lived dialysis patient who took note of what Scribner wrought all the way back with his first patient. At the heart of his technical and medical approaches was a heart filled with compassion that led his humanitarian calling to simply relieve pain and suffering and death in patients otherwise doomed to die. Yes, Scribner's legacy is an enduring legacy that lives on today. The "ideal" patient was simply the normal, "rehabilitated" patient in the Seattle program of the 1960's molded into a survivor by one man, Belding Scribner. That is a true and lasting legacy.

A tale of Two Cities, Seattle vs Boston, Began with the Kolff Dialysis Machines

Over 10 years ago, I wrote about the differences of the Seattle program with Belding Scribner and the Boston, Peter Bent Brigham Hospital Nephrology group in a blog I called the Tale of Two Cities. This was the beginning of the debate between long, slow and more frequent dialysis against the short, fast and violent dialysis practice patterns prevalent today in the US. While exploring historical records of the start of chronic dialysis with the Scribner Shunt in 1960, it became clear that the well intentioned, but erroneous development of the Kolff Rotating Drum kidney and the Kolff Twin Coil kidney were based on high Urea clearances, with shorter dialysis sessions. These two Kolff kidney machines not only served as a basis of acute kidney care around the world during the 1950's, but it also paradoxically began the short and infrequent treatments that has led to the worst outcomes of all the High Income Nations. 

Belding Scribner wrote an historical account of why the Seattle program chose long, slow and "frequent" (Thrice weekly).  Scrib noted that all of the complications that were involved in the initial treatment protocols came from the first patient, Clyde Shields. Their decisions included:

1) Long treatments instead of short. This was chosen with the Kiil kidney because it allowed a single pool of dialysate for the entire treatment instead of redoing the pool every two hours as with the Kolff machines. The long and slow treatments serendipitously promoted clearance of the middle molecules involved in uremic toxicity.

2) Long and slow also promoted slower removal of excess fluid without causing cardiovascular collapse.

3) Thrice weekly, long and slow was chosen to overcome uremic neuropathy and became a physiologic measure of dialysis dose which is still used today.

Willem Kolff worked closely with the Boston program and John Merrill beginning in 1948. The primary focus that Kolff considered in his machine designs was improved removed of Urea. Both the Kolff rotating drum and the Twin Coil Kidney had three times the clearance of Urea than the Kiil dialyzer which at that time seemed to be an important consideration, but we now know that urea kinetics do not correlate closely to survival. TIME and Frequency of dialysis sessions are much more important, independent factors in survival. Scribner noted this in his historical account in 2004:

Scribner BH, Cole JJ, Ahmad S, Blagg CR. Why thrice weekly dialysis? Hemodial Int. 2004 Apr 1;8(2):188-92. doi: 10.1111/j.1492-7535.2004.01094.x. PMID: 19379416.

"The fact that creation of our continuous flow hemodialysis system preceded development of the arteriovenous Teflon shunt for chronic dialysis unknowingly provided a great advantage over other dialysis programs that were using the Kolff rotating drum dialyzer or the twin-coil system. These dialyzers were very useful in the treatment of acute renal failure but unsuited to the treatment of chronic renal failure. Both required a dialysate bath change every 2 hr for a 6-hr dialysis and the twin-coil system also required a blood pump, adding complexity to the treatment. Furthermore, these dialysizers needed to be primed with 1 unit or more of blood, most of which could not be returned to the patient at the end of the dialysis. Although both had urea clearances more than three times that of the Skeggs-Leonards and the Kiil dialyzers, the total urea clearance per treatment was very similar.

Although we did not realize it at the time, our continuous-flow system also allowed a slight but perhaps crucial increase in the removal of toxic middle molecules as a result of dialyzing for 24hr once a week compared with 4 to 6hr treatments with the twin-coil system."

Thus began the debate on urea kinetics vs longer, slower and more frequent as the correct measure of dialysis dosage. There is little doubt that Scribner in retrospect chose well, and Kolff chose poorly in designing his machines based on urea removal which can occur rapidly and thoroughly with little time or frequency. While the rest of the developed nations followed the lead of Scribner and the Seattle program with longer, slower and more frequent treatment protocols, the US followed the lead of Kolff and Brigham nephrology doctors who used the Kolff twin-coil kidneys for nearly a decade of the chronic kidney programs. The Harvard/Brigham influence over US dialysis policy based on shorter and less frequent 9-12 hour weekly treatments began with Kolff who had 8-12 hours of treatment with his twice weekly 4-6 hour twin-coil kidney treatment protocols. These machines and schedules were excellent at removing urea and normalizing other laboratory parameters, but they were not based on the same clinical goals of the Scribner program to alleviate all symptoms of uremia with treatment including relief of HTN and improvement of uremic neuropathy.

We are still reaping death and deficiency from the decision by Willem Kolff believing that more rapid removal of urea would improve access, reduce costs and provide optimal care to more people. While Kolff did improve access and reduce costs, by focussing on a laboratory parameter, urea removal, Kolff inadvertently began a debate that remains unsettled and littered with the bodies of tens of thousands of patients suffering from the effects of too short and too infrequent dialysis sessions even though "the labs all look good."

 

How Clyde Shields taught Belding Scribner How to Perform Chronic Dialysis

When Belding Scribner solved the long term dialysis access problem of chronic dialysis with the Scribner Teflon Shunt, the biggest hurdle was cleared.  Unfortunately, “Scrib’s” very first chronic dialysis patient, Clyde Shields, suffered several severe and potentially life threatening complications shortly after beginning dialysis. Scribner had a dying patient in front of him even with his lifesaving vascular access allowing prolonged "chronic dialysis" and no prior case reports or studies on how to manage a chronic renal dialysis patient. Scribner, literally wrote the book on how to perform chronic dialysis well. Ironically, Scribner learned the most and was challenged the most with Clyde, his first patient. We have all benefited from what Clyde suffered and Scribner empirically got right.

Using reason, logic and empiric trials based on the evidence in the medical literature applied at the bedside, Scribner filled in the knowledge gaps immediately in a way that still applies to all dialysis patients that have followed even decades later. Here is short summary of some of the complications that Clyde Shields developed and Scribner and his team at Seattle found enduring solutions for that still apply today.

1) Clyde first developed Malignant Hypertension with very poor treatment options. (ganglion-blocking agents and reserpine)

Scribner instituted instead an empiric treatment of 400 mg/day sodium dietary restriction and aggressive ultrafiltration which quickly normalized Clyde’s BP and saved his life.

Scribner applied what he learned with Clyde to all of his patients, thus bringing forth the Drug Free Dry Weight method of BP control which is still the only successful treatment of ESRD patients on dialysis which is mainly a manifestation of the expanded Extracellular space due to excessive intake of sodium in the diet. Sadly, patients sometimes receive a sodium load even in dialysis with sodium levels often higher than the average patients plasma sodium levels. Thus, even at times in dialysis, they receive a net sodium gain and return home thirsty and unable to control their fluid intake. The average sodium level in the 1940’s with Kolff was 126.5 with 18 gm of Glucose to create a gradient to draw fluids. During the 1960’s and 1970's, it rose to 130-135 but now is as high as 149 in unusual circumstances with 140-141 very common.

Many studies show that a dialysate sodium levels of 140 often gives a sodium load leading to interdialytic weight gain (IDWG), increased thirst and the entire cycle of HTN followed by dramatic drops from excessive ultrafiltration during short treatments of 3-4 hours. Scribner’s dry weight method and matching the dialysis sodium to the serum sodium dramatically eliminates significant weight gain between sessions as my own case demonstrates. Sadly, the nephrology community at large has cast out all that Scribner learned, applied to his Drug Free Dry Weight method and that was replicated across the globe, most notably in Tassin France with Bernard Charra. Charra garnered over 95% Drug Free Dry Weight BP control within a few weeks of patients entering his clinic.

      Weight in Kg                                                                                                        (MAP)

 

Despite mountains of evidence accumulated by Scribner, Blagg and Kjellstrand and then replicated by Bernard Charra with over a combined 40 years of evidence of low sodium, probing dry weight with Ultrafiltration, the nephrology community struggles today to resolve the persistent hypertension plaguing patients and leads to high rates of cardiovascular events caused mainly by short, infrequent dialysis, poor adherence to low sodium diets and sodium loading during dialysis that is avoidable.

 Blood pressure and volume management in dialysis: conclusions from a

Kidney Disease Improving Global Outcomes (KDIGO) Conference

Strategies aimed at improving vascular compensation and/or tolerance of UF may also lower the risk of UF-induced intradialytic hypotension and are listed in Tables 4and 5. Altering dialysate sodium concentration is the most debated approach (Table 5). Prospective studies suggest that use of lower dialysate sodium is associated with lower IDWG and BP^90,91 but also show an association with intradialytic hypotension and symptoms, including cramps.⁹² Observational studies have yielded mixed results regarding the association of dialysate sodium and mortality.93, 94, 95 The Sodium Lowering in Dialysate (SoLID) RCT^96,97 assesses the effects of low versus standard dialysate sodium concentration on regression of left ventricular mass, with results pending. Therefore, the ideal dialysate sodium concentration remains uncertain. A large multinational, pragmatic trial is ongoing (RESOLVE, NCT02823821). Moreover, the prescribed and delivered dialysate sodium concentrations can differ, rendering individualization of prescriptions challenging and potentially unsafe.⁹⁸ In general, sodium balance should be negative during an HD treatment,¹ given the tension between enhanced vascular space viability during a single treatment and lower IDWG across many treatments.

Clyde suffered several other acute conditions which had not been faced previously, for which Scribner treated as manifestations of uremia. He increased TIME and/or Frequency resolving all of these issues along with application of new meds for deficiencies and physiologic alterations not seen before.

2) Gout like arthritis: Scribner reasoned that Clyde needed further dialysis and went to thrice weekly 8-10 hours.

3) Metastatic calcification. Scribner spoke with a GI colleague in the hallway who noted Aluminum antacids lower phosphorus levels dramatically thus starting the use of phosphorus binders. The Aluminum toxicity was not recognized for many years after but it completely cured the metastatic calcification issues. Synthetic Vit D was not available until the early 1970’s.

4) Uremic Neuropathy. This was another serious and potentially life threatening condition when it involves autonomic peripheral nerves, that Clyde developed fairly early in his course. Scribner again, with little evidence in the medical literature to guide him, concluded he had inadequate dialysis and hypothesized that the neuropathy could be relieved by increasing the frequency and duration of dialysis. They also began supplementing the water soluble vitamins at this time. Scribner measured the response to a higher dose of dialysis with serial nerve conduction studies, correlating his response to the higher dose with the velocity of his nerve conduction. Scribner then applied this as his measure of adequate dialysis dosage all his patients:

"Eventually, motor nerve conduction velocity measurements became the guideline to ensure minimum adequate dialysis!"

This turns out to still be the most objective clinical measurement of “adequate” dialysis we have today in 2023. There are dozens of studies  over the last two decades on uremic neuropathy corresponding to a measure of dialysis adequacy still in use today.

Effect of hemodiafiltration on the progression of neuropathy with kidney failure:

A randomized controlled trial

So, with Scribner’s first chronic hemodialysis patient, Clyde Shields, he devised an empiric treatment schedule of 8 hrs 3 times a week which matches kinetic modeling studies decades after he deduced this schedule at the patients bedside with clinical parameters alone. In addition, again at the patients bedside, using the powerful tools of logic and empiric trials, Scribner gave Clyde Shields 11 years of borrowed time, guiding him through several severe complications. This occurred without any RCT’s or prior case reports, but by his own clinical judgement and Clyde's response to empiric treatments. Scribner further defined one of the most sensitive objective measures of dialysis adequacy still in use today by monitoring effectiveness of the dosage of dialysis with nerve conduction studies and resolution or arrest of uremic neuropathy progression in 8/11 of his patients. He accomplished remarkable results still relevant today over 60 years later that are largely forgotten, or perhaps deliberately ignored. I am not sure which is operative. But the results are the same.

Patients suffer now while unending and often contradictory studies delay definitive treatment. Scribner stayed at the patients bedside with empiric trials until he discovered what worked in his very first patient. Otherwise Clyde would have been crippled and died many years before his eventual demise 11 years later. He did not abandon his patient to study an issue for 10 years as in the "failed" FHN Nocturnal study, and then debate the issue and validity of a failed study for another 10 years. 

It is time to remember the tools of a bedside clinician walking through the sufferings of their patients with them, making decisions that in the case of Clyde Shields, were instructive to all ages.

Are The Kings of the "Village of the Damned," The Peter Bent Brigham Hospital System? PART I

American dialysis outcomes are the worst within the High Income Countries (HIC) as shown with international studies by the Dialysis Outcomes and Practice Patterns Study (DOPPS). The findings show that it is the practice of dialysis  in America with short (2.5-3.5 hours/session in the 1980's), Rapid Ultrafiltration and reliance mainly on in-center treatment has brought America to this embarrassing low point in medical practice that has not significantly improved in the last 40 years. Other countries in the 1990's published opinion/editorials in medical journals begging their practitioners to not kill their patients like America. (here).

America started their dialysis legacy under the altruistic care of Belding Scribner and Willem Kolff who performed the first successful Hemodialysis session in 1943 in Nazi occupied Holland. The machine was made from parts scavenged from a washing machine and a sowing machine motor. The patient woke up from a uremic coma, but succumbed when Kolff ran out of usable vascular access sites. Instead of selling the rights to this miracle machine, Kolff freely gave it to the world. Kolff is known for many things, but one of his quotes sums up his whole mission in medicine: "The exciting thing is to see somebody who is doomed to die, live and be happy."

Although Kolff came to America and collaborated with other dialysis researchers such as John Merrill at Peter Bent Brigham Hospital helping to develop the Brigham/Kolff dialysis machine, no one over the next 17 years was able to manage a patient on hemodialysis for more than a few months due to lack of chronic vascular access. It was not until Belding Scribner, MD, motivated by the death of a patient from Spokane, WA came up with a solution when he woke from sleep that changed the trajectory of this miracle of modern medicine.

Belding Scribner, BMJ. 2003 Jul 19; 327(7407): 167

Scribner came upon his idea in 1960 after he saw a young man recover briefly following dialysis, only to die a few weeks later. At the time, haemodialysis could only be performed for a few cycles. In a painful procedure, glass tubes were inserted into a patient's blood vessels, permanently destroying them for further access.

The patient weighed on Scribner's mind until one night when he suddenly awoke with an idea of how to save patients with end stage kidney disease. He would fashion a loop between an artery and vein, allowing the device—rather than the patient's own vessels—to be opened and closed with each cycle of dialysis.

He enlisted instrument designer Wayne Quinton to work on his idea. They fashioned the U shaped device made of Teflon that would become known as the “Scribner shunt.” Teflon proved to have a special advantage over glass: its non-stick surface did not trigger blood clotting.

Both Kolff and Scribner shared the same altruistic motivation to simply save lives as Scribner likewise gave his lifesaving invention away freely and thus the era of chronic hemodialysis saving  patients otherwise doomed to a painful and difficult death by uremia. This era continued unabated with improving, life sparing treatments until, the advent of 1972 when the ESRD program was sponsored by CMS. This  gave patients with ESRD in the US under 65 access to Medicare benefits. Even though Belding Scribner lobbied congress and other officials throughout the 1960's for Federal funding, no one could imagine that this needed program designed to save lives would lead to the destruction of the legacy Scribner and Kolff had left for the world to follow and emulate. 

The irony of the 1972 ESRD program is  that the quality of dialysis began to fail in America when the program started. Belding Scribner came to this conclusion in his historical account of dialysis in America written in 1999:

Dialysis Therapy in the United States: A Historical Perspective

In my view, the quality of hemodialysis care in the  United States began to deteriorate when renal patients became eligible for Medicare coverage in 1972. The questions I pose herein are twofold: What went wrong with the quality of hemodialysis in the United States, and can that quality be improved?

There are two basic ways that hemodialysis affects the health and longevity of the patient with end-stage renal disease. The first is by the removal of uremic toxins; the second is by using the powerful tool, ultrafiltration, to normalize blood pressure (BP).

The history of toxin removal

During the 1960's and early 1970s, prescribing the correct dose of dialysis was pure guesswork. Criteria for adequate dialysis were based on clinical grounds: eradication of uremic manifestations and adequate rehabilitation {2,3}. Any uremic manifestation, including elevated blood pressure was considered inadequate dialysis in the early 1970's {4}.

How had this modern medical miracle, freely given to us through Kolff and Scribner end in death, misery and morbid conditions in US dialysis centers across this nation? The answer became abundantly clear to investigative journalists in the decades to follow at such institutions as the New York Times :

Death and Deficiency in Kidney Treatment

By Kurt Eichenwald

Dec. 4, 1995

Over the last decade, National Medical Care, a division of W. R. Grace & Company, has been accused in legal proceedings and by patients, medical experts and some Government investigators of a variety of shortcomings. These are among the actions by the company, critics say, that have led to deficiencies in care:

*Shifting the duties of doctors and registered nurses to lesser-trained and poorly supervised technicians and medical staff.

*Allowing the use of outdated, poorly maintained equipment.

*Manufacturing equipment that has not met Federal standards.

*Keeping patients on dialysis for too little time.

*Re-using disposable equipment that manufacturers -- including, for many years, a division of National Medical itself -- recommended be used only once.

*Diverting Federal money that could be spent on patient care to enrich its doctors for little work and to finance other businesses.

Christopher Blagg, MD, commented on an early post on HemoDoc about what happened to the excellent dialysis outcomes prior to the ESRD program and where it went wrong:

A Tale of Two Cities: The Story of Dialysis in America By Peter Laird MD,

Comments

Thanks Peter.It was a different world in the 1960s. In 1962 the Seattle Artifical Kidney Center was developed as the world's first out-of-hospital dialysis unit because the University of Washington Hospital would not allow Dr. Scribner further expansion for the dialysis program beyond the first 4 patients. Scrib and the King County Medical Society never thought of making their new center anything other than a community supported non-profit operation.
In similar circumstances a few years later the Brigham group developed an out-of-hospital unit that became for-profit and led to National Medical Care. When the Medicare progam began the potential profit margin was large and so dialysis flourished and led to what we see in the US today. As Dr. Scribner commented to a Congressional hearing and on 60 minutes, what began as a noble experiment degenerated into a a multi-million dollar money-making enterprise. Opposition by NMC to home hemodialysis - it was unsafe and the cost savings were exagerated - was one of the main reasons home hemodialysis withered throughout the 70s and 80s.

Posted by: Christopher Blagg | Tuesday, December 28, 2010 at 06:18 AM

Instead of health and restoration Scribner and Kolff brought forth from a 100% fatal disease prior to 1960, hemodialysis in America became a source of death, misery and pain as patients were dialyzed for as little as 2.5 hours thrice weekly. Belding Scribner with his first patient established 8 hours thrice weekly as what was needed to restore a patient and relieve their uremic symptoms and hypertension. Subsequent studies decades later by Sunny Eloot in Ghent Belgium performing exquisite solute studies showed why long, slow and frequent dialysis is the only physiologic approach that cleanse the body of uremic toxins in ESRD.

Impact of increasing haemodialysis frequency versus haemodialysis duration on removal of urea and guanidino compounds: a kinetic analysis

Sunny Eloot, Wim van Biesen, Annemieke Dhondt, Rita de Smet, Bart Marescau, Peter Paul De Deyn, Pascal Verdonck, Raymond Vanholder

https://doi.org/10.1093/ndt/gfp059

Background. Patients with renal failure retain a large variety of uraemic solutes, characterized by different kinetic behaviour. It is not entirely clear what the impact is of increasing dialysis frequency and/or duration on removal efficiency, nor whether this impact is the same for all types of solutes.

Methods. This study was based on two-compartmental kinetic data obtained in stable haemodialysis patients ( n = 7) for urea, creatinine (CREA), guanidinosuccinic acid (GSA) and methylguanidine (MG). For each individual patient, mathematical simulations were performed for different dialysis schedules, varying in frequency, duration and intensity. For each dialysis schedule, plasmatic and extraplasmatic weekly time-averaged concentrations (TAC) were calculated, as well as their %difference to weekly TAC of the reference dialysis schedule (three times weekly 4 h).

Results. Increasing dialysis duration was most beneficial for CREA and MG, which are distributed in a larger volume (54.0 ± 5.9 L and 102.6 ± 33.9 L) than urea (42.7 ± 6.0 L) [plasmatic weekly TAC decrease of 31.5 ± 3.2% and 31.8 ± 3.8% for CREA and MG with Q _B of 200 mL/min, compared to 25.7 ± 3.2% for urea ( P = 0.001 and P < 0.001)]. Increasing dialysis frequency resulted only in a limited increase in efficiency, most pronounced for solutes distributed in a small volume like GSA (30.6 ± 4.2 L). Increasing both duration and frequency results in weekly TAC decreases of >65% for all solutes. Comparable results were found in the extraplasmatic compartment.

Conclusion. Prolonged dialysis significantly reduces solute concentration levels, especially for those solutes that are distributed in a larger volume. Increasing both dialysis frequency and duration is the superior dialysis schedule.

Instead, even today, America dialysis patients are dialyzed for the shortest period of any HIC nation with rapid removal of fluids that leads to cramping or vomiting and passing out during almost every session for many patients. This leads to further serious health consequences giving American dialysis patients the shortest expected lifetimes and survival. Home Hemodialysis has never regained its place in America as it was in the early 1970's at 40% of the renal dialysis population.

The story of how America destroyed the legacy of Scriber's and Kolff's falls at the feet, mainly in my opinion, of National Medical Care Inc (NMC) and three individuals: Constance Hampers, MD, Eugene Shupack, MD and Edmond G. Lowrie. All three were involved with NMC as either founders or leaders of this for-profit dialysis corporation. However, there is a more fundamental connection between all of them: they all trained at Peter Bent Brigham Hospital Nephrology. Thus began a long chain of undue influence, in my opinion, from Peter Bent Brigham Hospital that remains today and stands, in my opinion, in opposition to optimal dialysis that Scribner defined as that which relieves all uremic symptoms and hypertension. Todays, American style, short, fast and violent dialysis sessions are noted for patients who become disabled and often hypertensive with excessive fluid gains between sessions. The saga of what, in my opinion, is the undue influence of the Peter Bent Brigham Nephrology program as seen in a simple chart of their program leaders and graduates who are some of the leading researchers in dialysis today as well as leaders of the for profit dialysis industry that perpetuates America's failed dialysis practices.

 

https://www.brighamandwomens.org/assets/BWH/medicine/pdfs/lazarus-early-dialysis-part3.pdf

It is my opinion that the works of Gus Hampers and Edmund G. Lowrie are continued in their students legacy of pervasive studies that ask the wrong clinical questions and perpetuate short, fast and violent dialysis sessions.  In my next post in this series, I will review how this one nephrology program has dominated the entire American dialysis practice patterns and the academic dialysis studies over the last 50 years through for profit medicine and academic studies protecting their for-profit practice patterns. 

How to Make A Killing by Tom Mueller

From the dreams of a long and fruitful career in medicine, the story of dialysis in America has instead become the story of my own life. Tom Mueller spent six years researching and learning about the heart of  American dialysis and why it started with such hope and devotion but has devolved into a mainly for-profit duopoly filled with greed and indifference. Many of the people mentioned in this meaningful book have been my own personal friends and colleagues in a battle to bring "optimal" dialysis back to America.

Belding Scribner, MD and his colleagues in Seattle such as Christopher Blagg, MD built a lifesaving device into an entire medical field that was the first to be able to replace a non-functioning organ and give the gift of life back to millions of patients around the world. In many ways, what Dr. Scribner put together in the 1960's was the peak of dialysis with his first experimental treatment resulting in 11 years of extended life alone for Clyde Shields. Unfortunately, dialysis in the US has not progressed as the other fields of medicine in the same period of time except as it did as a device for profiteering and greed.

Nancy Spaeth who began dialysis with Dr. Scribner on December 26th, 1966 has stated that her home dialysis in the 1960's gave her the best benefits of her entire life compared to what she experienced later with shorter, and faster dialysis in the 70s and 80's. For all who have experienced renal failure in the US, this is our story that Tom Mueller brings to view through his talents as an author and humanist concerned with the inhumane treatments of far too many of my fellow dialysis patients, all for the love of money alone. Nancy lived life well until last year and is an author, a nurse, a mother, and grandmother and revered friend to thousands of dialysis patients around the world who she encouraged and supported.

I am one of those who was given the gift of life through dialysis and I have now enjoyed nearly 17 years of borrowed time. But, those years have been fraught with the disappointment of a medical field that has sold its soul for monetary gain at the expense of suffering and death of those that they are charged to protect and care. 

Tom Mueller captures this story through the eyes of another one of my friends and hero's in this life, Arlene Mullins. Over 23 years ago, Arlene made a promise to her then dying husband that she would save as many dialysis patients as she could from corporations and government oversight that maximized profits while producing the worst dialysis outcomes in the developed world. Arlene and hundreds of whistleblowers, civil rights and legal groups are now converging to bring this story that is largely ignored except by those who are forced to endure an industry gone wrong through greed. Belding Scribner said it best as noted by his friend, Christopher Blagg:

"Scrib was always interested in the big picture. In 1961, he was espousing development of dialysis centers but progress was slow. By 1965, he had seen the success and cost savings with home hemodialysis and was urging its use to enable more patients to be treated. Senator Henry Jackson, who had a childhood friend on dialysis, introduced the first legislation for government support of dialysis and transplantation in 1965. Scrib’s views were also a major influence on the Gottschalk Committee that looked at the potential role of government in 1967. He, among others, helped to get Congress to pass legis- lation for the Medicare End Stage Renal Disease Program in 1972, but later became disillusioned as he saw the large profits in the early years and the growth of for-profit dialysis organi- zations. He said that what he had regarded as “a noble experiment” had become a vehicle fueled by greed rather than concern for providing the best treatment for patients. He continued his interest in renal politics for the rest of his life."

https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=9c1f3477168924153487d40fd15b772f2bd22d20

I urge all to read and share the story that Tom Mueller has published in support of the fight for truth and healing of a medical field in need of remembering where it all started, with a man who gave freely to his patents so that patients could live and prosper even with full renal failure. HOW TO MAKE A KILLING, by Tom Mueller is a tribute to Dr. Willem Kolff who invented the first workable dialysis machine and freely gave his machines to the world to save lives.

"The exciting thing is to see somebody who is doomed to die, live and be happy.

https://achievement.org/achiever/willem-j-kolff/

Dr. Scribner gave his Scribner shunt and other medical devices freely to the world to simply save lives. It is time that nephrologists in America remember and honor how this noble experiment gave life to people like myself and millions around the world. It still is a noble experiment that deserves to return to what Scribner and Kolff envisioned well over sixty years ago. Would it be that we will see many people doomed to die, live and be happy.

HOW TO MAKE A KILLING, by Tom Mueller is an important book that all who have or ever will need the benefits of humane and compassionate medical care will appreciate for his visionary insight into the perils of for-profit medicine.

CMS and Home Hemodialysis: The Story of 40 Years of Neglect

By Peter Laird, MD

The 1973 ESRD Program began with an aura of hope and expectation of ending the suffering of countless renal patients ravaged by a disease that had only recently been a certain death sentence by slow and protracted suffering.  The "nobel experiment" which came to life by the serendipitous invention of a simple shunt became a Federally funded entitlement program literally by the stroke of a pen.

End Stage Renal Disease Program

In 1972 the United States Congress passed legislation authorizing the End Stage Renal Disease Program (ESRD) under Medicare. Section 299I of Public Law 92-603, passed on October 30, 1972, extended Medicare coverage to Americans if they had stage five chronic kidney disease (CKD) and were otherwise qualified under Medicare's work history requirements. The program's launch was July 1, 1973. 

At the start of the ESRD Program, the National Dialysis Registry data shows that on January 1, 1972 40.2% (2,001) of 4,981 patients were on home dialysis - HHD + PD - there were only 25 PD patients at home. 

On January 1, 1974 the figure was 33.0% (3,402) of 10,306 patients  were on home dialysis including 59 PD patients at home.

The politics of home hemodialysis then sadly began in earnest. The pioneers of dialysis developed home treatments to augment the few available hospital based dialysis machines to expand the number of patients that they could treat effectively. Home hemodialysis treatments were significantly cheaper than the in-center treatments by nearly a third in the early days of the ESRD program. 

NBC Commentator Dr. Arthur Caplan Calls Dialysis Cruel and Lousy Care

Data supplied by Richard Rettig,(page 3) a Rand Corporation scholar, shows that in 1972, in-center dialysis costs were between $27,600 - $30,500 while at the same time home dialysis costs were only $14,900 for the first year of therapy and only $7000 for each year there after.

The true tipping point between acceptance of home hemodialysis vs. in-center treatments came in the 1978 congressional hearings prompted by escalating costs of the ESRD Program. At that time, Edmund G. Lowrie, Vice President of National Medical Care, Inc., promoted a false understanding of the costs and effectiveness of home hemodialysis that Dr. Chris Blagg was unable to overcome in his testimony which fell on the deaf ears of those who refused to hear the true story.

The politics of health cost containment: end-stage renal disease

R.A. Rettig (pages 132-133)

Dr. Edmund Lowrie of Peter Brent Brigham Hospital attacked the Seattle experience directly on two points: "our analysis indicates that the cost of self-care dialysis is not significatly less than limited care dialysis, and that the the indiscriminate use of home dialysis may lead to unacceptable patient mortality." . . . "After careful analysis," Lowrie claimed, "the only obvious reason for this inferior patient survival that we can think of is the indiscriminate use of home dialysis therapy." Lowrie's testimony created the impression that three-year survival of home patients in Seattle was unacceptably low. But as Blagg later pointed out, the 58% applied to all Seattle patients, center and home, and inclued elderly and diabetics insignificant numbers."When we look at patient survival on home dialysis," Blagg wrote, "and exlude the center dialysis patients, the 3-year survival in our program is 74 percent including diabetics; if we exlude diabetics, the 3-year survival rate in pateints aged 55 of less is 81 percent on home dialysis. . .

But the political damage had been done. 

Today, after nearly forty years of neglect, home hemodialysis is only a shadow of its humble beginnings mainly due to adverse funding ratios from the hands of congress and CMS. Despite an abundance of evidence of its cost effectiveness, despite widespread acceptance in the rest of the developed world, home hemodialysis remains underutilized and underfunded today despite promises to the contrary.

NxStage internal data presented to CMS in recent public comments on the Renal Bundle and the QIP reveals significant discrepencies between reimbursement for peritoneal dialysis vs. home hemodialysis despite significantly longer training requirements for home hemodialysis (HHD) and and higher associated training costs. Total hours training, PD  - 32, HHD - 103. Reimbursement: PD $1,238, HHD - $408. Estimated HHD costs in a 2007 NxStage survey showed the burden of training for one HHD  patient was at least $4000.

The lack of adequate compensation for necessary training presents an undue disincentive to further acceptance of HHD as the modality of choice for selected patients. According to the same NxStage public comments, only 24% of current dialysis centers are certified for HHD and even fewer enroll patients into their programs despite extensive clinical data of improved outcomes with HHD. Adding to the financial disincentives, few nephrologists or units ever counsel patients on the benefits of home hemodialysis with as few as 12% of patients receiving informed consent on this underutilized modality. (here) Further studies reveal increased requests for home hemodialysis when patients are informed of this option showing the effectiveness of patient education on HHD. (here)

Despite substantial benefit, reduced long-term costs, and proven efficacy of informed consent for HHD, CMS continues to neglect this much unfairly maligned therapy. For those fortunate enough to participate in home hemodialysis training and treatment, the benefits are immediate and longstanding as noted by frequent testimonies on various dialysis advocacy web pages. Only congress and CMS fully appreciate their own reasons for why the continue to withhold appropriate funding of HHD after nearly forty years.

This puzzling story continues to defy any reason and logic. Perhaps one day, enough dialysis patients will know and understand why it should often be their first choice and a shout will go forth that no one can ignore any longer at CMS. But until that day, the voice of despair and discontent with conventional in-center hemodialysis will apparently continue to fall on deaf ears. Perhaps one day, we can only hope that someone, somewhere  and at some time one who can make a difference inside our government will.

The "Lucky 13": Survivors from the Early Days of Dialysis

By Peter Laird, MD

Patients undergoing dialysis in America units frequently complain of the misery of their existence with headaches, severe thirst after sessions, cramps, nausea, vomiting, frequent bouts of low blood pressure and the misery of an ever present fatigue that permeates every aspect of their lives. It is no wonder that so many people hate dialysis. These attitudes were not shared by those few lucky to be the first pioneer patients of dialysis in the 1960's in London and Seattle especially, several of whom still are alive today more than forty five years since they were first saved by this therapy (here). The first patients in England are dubbed the "lucky 13."

History of Nephrology: The Record Holders

The Royal Free programme
This photograph of 'The Lucky Thirteen' taken in 1965 shows patients treated at the UK's first centre for long-term dialysis at the Royal Free Hospital, London, with their consultant Dr Stanley Shaldon (centre, front row).  Olga Hepple, left of Dr Shaldon, featured in a Pathe film of very early home haemodialysis in the UK.  Three of them featured in the first episode of the BBC's Tomorrow's World in 1965, which you can see online, a remarkable historical record.

With the median survival for America dialysis patients today of 36-38 months, the thought of surviving for nearly half a century with renal replacement therapy is not the current ideology of most involved with our dialysis industry.  With equipment we consider primitive, the article in the history of nephrology describes what these unique patients have in common:

What do they have in common?
All recognise that they have been lucky.  In the early days, it wasn't easy to get dialysis but the struggle to get onto treatment was just the beginning.  All are grateful for the opportunities that they did not expect to have, and to their families and the medical teams that shared these struggles.  

All of the very long term survivors have spent long periods transplanted, but it is interesting that several of them waited years or decades before their first.  This may have saved them, as the risks of transplantation in the early years were extremely high.  None of the very early transplant recipients are still alive. Most longterm survivors have had long periods of very long-hours dialysis, and this may be important too.  

All of these patients through a combination of extended hours dialysis in the beginning are alive today as a testimony and legacy of Belding Scribner who prescribed longer treatments for any patient who was not rehabilitated. The patient killing metrics of urea kinetics and the terms "adequate dialysis" are foreign to this story.  Dr. Robin Eady waited for twenty five years before he agreed to renal transplantation. He is now nearly fifty years as a renal patient. The will to live and comply with the difficulties of treatments is now his reward for a life well lived, not only as a patient, but as a practicing and successful physician who is highly regarded in his field of dermatology.

Perhaps the element most lacking for patients today is that of hope which has been replaced by despair and complacency by so many patients. The number of patients who could benefit from home hemodialysis is much larger than those that come forward even when offered. The examples of these remarkable patients  serves as a reminder that dialysis truly is the first gift of life in the history of renal replacement therapy. The "lucky 13"and those from several other pioneering programs in the 1960's should remind us that we can do better in America each and every day when we see several still alive today. The legacy of those who went before us and are still alive speaks of how far we have fallen from the precepts of the pioneers of dialysis. The "lucky 13" reminds us that it is not too late to recapture the wonder of life and rehabilitation from a machine.

Perhaps one day, American nephrology will remember the history of dialysis and ask the simple question, where have we gone wrong? Perhaps the answer is the day that this specialty began to pay more attention to biochemical parameters than the patients languishing in their dialysis units. America is not doing well in this "nobel experiment." It is time to learn from history and from those still alive. It is not too late.

The Japanese Dialysis Survival Debate: Ignoring the Evidence

By Peter Laird, MD

The survival differences between Japan and the United States are well documented and extensively researched with the preponderance of the evidence focusing on dialysis practice difference.  I have written on this issue several times in the past three years. (here, here and here) Many have wrongly in my opinion put forth the low incidence of renal transplant in Japan and alleged exclusion criteria coupled with lower co-morbid conditions that have not withstood the light of day as the explanation of these differences. Dr. A.K. Singh entered this debate a few days ago on his Kidney Doctor Blog:

Global Nephrology: Better Cars in Japan Maybe, but also Better Dialysis? The bottom-line?

There are a number of differences in dialysis practice that alone or together could explain the difference in mortality. While the very low transplantation rate in Japan, i.e. selection bias, might be a part of the explanation, it does not explain the two-fold higher mortality rate in the US. In Japan, like the US, there is a highly prevalent diabetic population on dialysis with an average age in the 60s that similarly dialyzes 3 times a week in center. It's either better dialysis or some other factor, but not just differences in transplant rates, nor is it because the Japanese are very selective in who they treat on dialysis.

The underlying untold story line to the great Japanese dialysis survival debate is the allegation that we could never take a group of patients in America and duplicate the Japanese survival outcomes with only a change in dialysis practice due to alleged higher co-morbidities, alleged lower incidence of diabetes, and alleged selection bias. I would urge all to consider that we actually have these answers already starting first of all historically when home dialysis patients and in-center dialysis patients had outcomes as equal or better than the current Japanese survival data. Dr. Lowrie boasted of a mortality rate as low as 7% in 1972:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 receivedcadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Many would state that the dialysis patient of 1972 was younger and diabetics were excluded explaining the historical data by selection bias and exclusion criteria. I won't debate the merits or lack of merit of that type of argument at this point, but let us move on to the real issue; if we changed dialysis practices here in America, could we duplicate the Japanese survival data with a large cohort of American dialysis patients. The answer to that question is yes with 5000 dialysis patients in a CMS demonstration project by Fresenius  which recorded a 9.3% annual mortality rate on thrice weekly in-center dialysis:

The first three years of the demonstration (2006 through 2008) were evaluated and the case-mix adjusted results indicate the following for Fresenius Medical Care (FMC) patients enrolled in the demonstration:

• A significantly larger percentage of patients in the FMC program survived to the one year and two year time points.
  • Patient survival at the one year time point for FMC was 90.7% vs 85.4% for the comparison group. Patient survival at the two year time point for FMC was 80.1% vs 73.9% for the comparison group. This equates to mortality improvement for FMC versus the comparison group of 36.3% at the one year time point (9.3% vs 14.6%) and 23.8% at the two year time point (19.9% vs 26.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “all causes” at one year of 13.6% (51.1% vs 59.1%) and at two years 20.5% (60.5% vs 76.1%).
• A significantly lower percentage of patients in the FMC program were hospitalized for cardiovascular disease for the first time by one year and two years.
  • Improvement for FMC versus the comparison group in first hospitalizations for “cardiovascular disease” at one year of 14.1% (50.0% vs 58.2%) and at two years 20.7% (59.7% vs 75.2%).

This project utilizing the Medicare Advantage allocation which has no wall between Part A and Part B in a capitated system allowing Fresenius to eliminate the extra profit centers in fee for service practice at the hospital and other points of care that standard Medicare cannot eliminate. This study has not received broad attention especially given that this was with standard 3.5 hours thrice weekly dialysis in-center. What is also not published nor recognized widely is that Fresenius accomplished similar outcomes in their joint Kaiser/FMC ventures in Southern California which I was able to observe firsthand for two years as a patient. Changing practices by first of all aligning cost incentives to prevent hospitalization and outside medical utilization results in cost containment and improved survival. The principle investigator for Fresenius offered detailed analysis of why they were able to achieve these results in an interview with Medscape:

Battling ESRD With Nutrition and Monitoring: Fresenius Project: the Interview

Mr. Farrell: We really think this is right in the sweet spot of where CMS wants to take health reform. One point about our demonstration program was that this was individual enrollment of patients, so at any given dialysis clinic you might have a handful of patients who choose to enroll in this program. This presents an opportunity when you move to a broader accountable care structure. What we have proposed with CMS is the concept of the integrated care health home, with the nephrologist as the principal care physician for these patients and the dialysis clinic provider and our integrated care program providing the data systems and care program infrastructure of the medical home. We'd like to see CMS give us an opportunity to deploy this kind of a model on a full clinic basis rather than individual patient enrollment. This would give us the opportunity to operationalize this model in a more integrated and efficient manner with our clinics and nephrologists in support of our patients. We're very encouraged by the results we were able to achieve in this demonstration project, even in this individual enrollment environment, but see a huge opportunity for ESRD patients if we are able to deploy this model on a larger scale.

If this model sounds familiar, it is because it is the integrated medical care system that Kaiser pioneered over fifty years ago which allows the provider to capitalize on economies of scale and to capture the health care savings by preventing illness and undo utilization of resources. In addition, I have reported on the benefits of nutritional supplementation in the dialysis unit nearly three years ago on DSEN:

Food Insecurity: The Shameful Secret Affecting Dialysis Patients

In the vacuum left by Medicare, some nephrologists have taken matters into their own hands. One exceptional example is Dr. Phillip Tuso, a nephrologist with Kaiser Permanente who created FIRN in response to the high number of his own patients with food insecurity that were dying at an alarming rate from malnutrition. Dr. Tuso started this non profit organization dedicated to relieving food insecurity within his dialysis population which has succeeded greatly in reducing mortality among his dialysis patients. Hospitalizations are likewise over 50% lower than before he began this intervention in 2004 saving Kaiser Permanente millions of dollars from one dialysis unit alone.

One nephrologist who was motivated by the knowledge of a simple and cost effective intervention with nutritional supplements serves as a outstanding model for how America could once again regain the threshold of humane care of those at risk of food insecurity in our dialysis population. It is time for America to save both lives and money with a simple intervention with oral nutritional supplements. The best medicine is once again the cheapest medicine.

I believe the Japanese survival debate is a false debate clouded by a lack of evaluation of known data and by ignoring extensive studies revealing that the cause of our different outcomes is our different dialysis practices. The American dialysis patient is not the cause of our terrible outcomes as many academic American nephrologists would like all of us to believe. In addition,  Japan also has a different payment system where nephrologists are paid per hour of dialysis not per session of dialysis. I have spoken to many leaders in the dialysis industry in the last three years and many place the blame of our outcomes squarely on our perverse payment system that does not reward dialysis providers for keeping patients out of the hospital and avoiding complications.

I believe it is time to go beyond vacuous debates that fail to examine all of the evidence and instead to move forward with concrete practice changes already demonstrated in Europe, Japan, Australia and even right here in America that I have witnessed firsthand. Practice patterns will change when CMS creates incentives for outcomes instead of processes or biochemical profiles. Practice patterns differences are the reason for the excellent Japanese survival on dialysis and I believe that we can not only duplicate but surpass their survival rates by combining the practice changes that Fresenius utilized in an integrated care system with standard thrice weekly in-center dialysis and nutrition and holistic support and then surpassing that model by incorporating daily dialysis. That is the experiment and the direction that we need to take and stop endless and useless debates long since settled by the preponderance of the evidence.

The Kjellstrand Lecture: The Deadly Delay - Part IV: Survival

By Peter Laird, MD

Since the advent of hemodialysis with the Scribner Shunt in 1960, chronic hemodialysis became the most widely utilized renal replacement therapy which is still true until today. Prior to the ESRD program in 1973, dialysis survival rates were substantially higher than today as noted by Edmund G. Lowrie in a NEJM article on transplant and dialysis survival rates:

Survival of Patients Undergoing Chronic Hemodialysis and Renal
Transplantation

Over an eight-year period 172 patients received an allograft from a living, related donor, 112 received cadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)

Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.

Survival rates prior to the ESRD program were on the average of around 10% annual mortality in many centers around this nation; the equivalent of the annual Japanese dialysis population today. However, since the NCDS instituted urea kinetics as the standard of care in the early 1980's and shorter and more violent dialysis sessions became the norm in America, annual mortality rates have more than doubled and have hovered around 22% as they are today with no significant improvement in the last twenty years. Many fail to realize that the five year survival for dialysis patients is worse than many of our most dreaded cancers and other ailments.

Sadly, the American nephrology community as a whole has ignored the pioneering work of Scribner and his colleagues for nearly three decades as preventable deaths soared. Many fail to remember that Dr. Lowrie recorded annual mortality as low as 7% in 1972 as the gold standard renal replacement therapy, even better than renal transplant at that time. Beginning in the 1990's with the investigation of daily, nocturnal home hemodialysis by Uldall and Pierratos, short daily and nocturnal dialysis modalities have shown significant survival benefit in line with the original survival in the 1960's and early 1970's.

Today, we have several well done observation studies following patients on daily dialysis for several years. These results are not center specific and have been duplicated in the United States, Australia and Canada. Dr. Carl Kjellstrand has supported daily dialysis for nearly forty years while instead, his colleagues adopted shorter and shorter dialysis sessions supported by the measurement of urea kinetics.

After all, the randomized and controlled trial, the NCDS had "proven" that the length of a dialysis session as measured in "TIME" had no statistically significant correlation with outcomes. Amazingly, the NCDS is still quoted widely by dialysis experts debating the outcomes of these observational studies yet fail to question why the dialysis outcomes forty years ago with inferior equipment, inferior knowledge of secondary morbidity associated with dialysis and inferior pharmaceutical support had paradoxically far superior outcomes.

Just as in 1973, without the benefit of randomized and controlled trials, the standard of comparison for the effectiveness of the renal replacement therapies was a direct comparison between the modalities.  Just as in 1973, dialysis and renal transplant which by the way has NEVER had a single randomized and controlled trial compared to dialysis outcomes is one measure of renal replacement therapy that does give comparative meaningful values.  Dr. Kjellstrand compared his own short daily dialysis studies with over twenty years of data to the USRDS in-center PD and HD patients as well as the renal transplant revealing equal survival with the daily dialysis options.

In 2009, Pauly, et al likewise utilized the measuring stick of transplant survival and compared their results directly to the average survival of living donor transplant and cadaveric transplants. Despite the number of earlier studies showing equal results as well as the original outcomes all the way back to the time of Dr. Lowrie's 1973 article with 7% annual mortality, many continue to question the validity of Dr. Pauly's results since they are observational in nature and not from a randomized and controlled trial.

After fifty years of data collection, the American nephrology community remains in a catatonic state paralyzed by indecision on what is the basic and standard dialysis dosage. Urea kinetics has brainwashed the American nephrologist into an altered state of consciousness in blissful ignorance of the damage done to millions of patients by poorly conducted and openly accepted randomized and controlled trials including the HEMO study which simply asked the wrong question: is a higher Kt/V the answer for survival. They likewise never question the lack of RCT studies proving thrice weekly, 3-4 hour treatments against the standard of thrice weekly 6-8 hour treatments.

The American nephrologist is religiously vested in the irrational belief that urea removal has clinical importance when we know that higher blood flows, higher ultrafiltration rates, high flux kidneys and other factors which completely ignore the underlying "unphysiology" of dialysis can all be manipulated to "improve" urea kinetics while at the same time our average annual survival is double the rate prior to the introduction of urea kinetics in the 1970's and early 1980's especially after the NCDS.

The early pioneers utlized very simple clinical monitors of how "adequate" the dialysis was for an individual patient, that of survival and rehabilitation. If the patient didn't feel well enough to return to work and a have viable life, the pioneers of dialysis simply increased their dosage in time on dialysis. That is how they derived the minimum standard dosage of thrice weekly 6-8 hour sessions most of which were done at home ovenight.

Now, a year and a half after the publication of the FHN short daily dialysis study, all that the American nephrologist can offer as advice is that we need larger and clearer endpoints in another randomized and controlled trial looking at mortality. Certainly ASN and the RPA have not in any manner stated that the standard of care for all dialysis patients should be daily dialysis with the best results from NHHD. Some illogically utilize the known results of the "killer" weekend to suggest we have equipoise, the genuine uncertainty over whether a treatment will be beneficial, to justify such a study. It appears that they are the only group that believes we have clinical uncertainty in daily dialysis. They have certainly forgotten that the NEJM and Dr. Lowrie used dialysis outcomes as the gold standard to compare mortality to renal transplant with dialysis outcomes better in those days, double the survival of transplant in its early years. We now have double the survival with transplant, but only if we don't compare it directly to optimal dialysis strategies that return us to the historical mortality rate noted by Lowrie in 1972.  A short memory of the history of dialysis is in many ways our worst enemy of the truth.

In 2001, those that supported the FHN promised it would be the arbiter of these questions. Although the short daily dialysis study did offer up a positive result, many American nephrologists reject its conclusions based on the coprimary outcomes that do not differentiate the contributions of death and LVMI separately for individual analysis, thus rendering its positive outcomes wasted. Likewise, the failed recruitment and changes to the exclusion criteria of the nocturnal study leave us without any direct conclusions from the FHN nocturnal arm. After ten years of a deadly delay, the FHN has not lived up to its promise and the American nephrology community remains unconvinced. At this point, I am not sure that CMS or the American academic nephrology community will ever be convinced. Instead, it will be the market place and patient demand that turn the tide on the economics of daily dialysis that will lead to a rebound of optimal therapy.

Hopefully, the American nephrologist will return to the patient and ask the simple questions that Dr. Scribner and his colleagues asked? How do you feel? Can you work? Have we restored your life? Until those simple questions once again become the measure of adequacy, the mental masturbation of making the nephrologist feel good about the patient's Kt/V while the patients life paradoxically slips away may one day come to an end. We can only hope that we avoid any further deadly delays.

Slides courtesy of Dr. Carl Kjellstrand.

The Kjellstrand Lecture: The Deadly Delay - Part I: Introduction

By Peter Laird, MD

Dr. Carl Kjellstrand is one of the most published and respected investigational researchers in the dialysis field of nephrology. For those that strive to overcome the hegemony of optimal dialysis in America, Dr Kjellstrand is a champion of daily dialysis and with good reason with hundreds of journal publications in a long career spanning several decades.

I  recently asked Dr.Kjellstrand if I could have a copy of his lecture from the 2009 Annual Dialysis Conference questioning the need for further randomized and controlled trials on more frequent dialysis. Dr. Kjellstrand has been gracious enough to not only share these slides with me, but to also allow this issue to be revisited one more time from the perspective he had prior to the completion of the FHN in 2010. As Dr. Kjellstrand summarized to me, he thinks it is "even more appropriate now."

The FHN is one of the most controversial trials in the field of nephrology among those that have a vested interest in dialysis outcomes, i.e. the patients themselves. CMS is one of the principle advocates that promoted this study citing the need to know that more frequent dialysis is the best dialysis modality before authorizing payment for more than the standard thrice weekly 3-4 hour conventional in-center dosage. It is truly a shame that CMS did not demand the same level of proof when CMS implemented the business friendly shortened dialysis schedule from what was the standard thrice weekly 6-8 hour nocturnal at home therapy in the 1970's.  

If they had demanded the same level of proof that they demand to return to the original optimal rehabilitative dose worked out by Dr. Scribner and his colleagues, we wouldn't have wasted nearly forty years debating this topic; needless to say of the hundreds of thousands of patients who have suffered and died during those years. Consider that there would not have been the recruitment issues that hampered the FHN because in the 1970's, the patients wanted the option of short dialysis treatments provided outside of their homes. Today, patients understand that the business of dialysis as practiced today is not good for their survival on dialysis and refuse to forego home dialysis options and have a 50% chance of staying in the confines of conventional in-center hemodialysis to participate in these studies. The one definitive finding of the FHN nocturnal study is that patients don't want to stay in-center when they have the ability to do dialysis at home. For patients, there is no "equipoise."

Dr. Kjellstrand entered this debate in 1975 with the Unphysiology Theory of  conventional in-center dialysis:

Dialysis Unphysiology and Sodium Balance

Dialysis unphysiology was first discussed by Carl Kjellstrand in 1975 for the possible negative effects of the unphysiology of intermittent dialysis treatment. Current hemodialysis practices are still unphysiologic because they cannot keep blood chemistries within normal limits, both before and after dialysis. In addition, the discontinuous nature of hemodialysis causes saw-tooth volume fluctuations, and the extracellular fluid volume expansion during the interdialytic period may lead to hypertension and adverse cardiovascular consequences.

While the academic world of dialysis continues to debate this issue for over forty years, many of whom with strong ties to the dialysis industry with conflicts of interest that were not reported in the early days of dialysis studies, thousands of patients needlessly die every month.

The most popular topic for dialysis advocacy posts on essentially every dialysis related blog is whether more frequent dialysis will improve outcomes. Now, more than one year after the publication of the short daily dialysis arm of the FHN, we still have no changes in the dialysis practices that Dr. Kjellstrand reveals as a preventable cause of 100 deaths  a day. Even with the positive results of the Culleton trial and the short daily FHN arm, the nocturnal portion of the FHN has produced further disunity on how to proceed. Instead of providing the guidance needed, the FHN instead is  a source of more confusion and debate on these issues.

As Dr. Kjellstrand stated about his 2009 lecture, it is "even more appropriate now." I invite all to review the evidence presented by Dr. Kjellstrand from his viewpoint  in 2009 prior to the completion of the FHN. In my opinion, the entire debate on the frequency and duration of dialysis sessions has for decades ignored the simple unphysiology of dialysis described in detail in 1975. I know of no other specialty in medicine that has so ignored basic science principles than nephrology for the one procedure most identified by this specialty.

Yes, it is even more appropriate now to revisit this issue one more time. Perhaps before the 40th anniversary of Dr. Kjellstrand's 1975 paper, his colleagues who have declared his views "controversial" for years will finally recognize his contributions and design optimal dialysis modalities around this unifying theme. History shall recognize that he was right all along. Yet the pride of those that irrationally oppose his theories can never justify the deadly death toll that mounts daily from their intransigent rejection of his views. It is time to revisit what we knew before the FHN was published and move forward with optimal dialysis. The time for study has passed. It is time to put this ten year deadly delay to rest once and for all.

(I wish to thank Dr. Kjellstrand for making this lecture and his actual slides available to the dialysis patients of America, most of whom will not have the opportunity to hear him speak in person.)