HemoDoc, From Doctor to Patient

The Mechanistic Destruction of Scribner's Legacy: The NCDS Legacy of Death and Morbidity, Part I

We are indebted to the contributions of Dr. Belding Scribner in defining optimal dialysis through his wise use of empiricism,  clinical judgement and humanitarianism. Dr. Scribner defined the optimal  weekly TIME (18-24 hrs), frequency, intensity of dialysis treatments and approach to common complications such as HTN and uremic neuropathy. All of these issues were settled in many ways with his very first patient, Clyde Shields. Scribner's meticulous attention to detail defined with his first patient the most important and foundational patterns of practice for dialysis that still apply today.

Outcomes in the dialysis pioneering age of Dr. Scribner and his like-minded colleagues still rival the best outcomes in the world today which we find in Japan and Tassin, France. TIME and Frequency in Japan and Tassin are at the heart of their treatment patterns of practice. Our understanding of uremic toxins through qualitative solute modeling studies show why TIME and Frequency are the most important independent factors of not only feeling well, but also increased longevity. Longevity is not a word ordinarily associated with America's sickly and hypertensive ESRD population. In many ways, American nephrology has been beguiled by urea kinetics and ignores the more important clinical parameters that guided Scribner.  The focus in the dialysis pioneering era was the patients well being as a measure of dialysis adequacy, which was later quantified with Nerve Conduction velocities based on the "dosage" of dialysis and improvement of uremic neuropathy. Motor Nerve Conduction velocities are still used today to measure, "the dosage of dialysis adequacy" (here and here).

The standard of care prior to the 1972 ESRD program was initialed was 6-8 hours thrice weekly, mainly at home as established by not only the Scribner, Seattle program, but also by Stanley Shaldon in London. It was a successful program and cost effective at 2/3rd's the costs of incenter after the 1st year investment of machines and set up. Northwest Kidney Centers in Seattle had approximately 90% of their patients on Home Hemodialysis with plans to downsize their in-center program as the home program continued to expand. All of this changed as soon as the 1972 ESRD program began. Instead of long, slow and frequent dialysis strategies, for-profit oriented dialysis centers enacted the Brigham, short, fast and violent dialysis sessions developed in Boston at the Peter Bent Brigham Hospital nephrology program by placing their trust in urea removal at higher rates from the Kolff twin-coil kidney.  

Willem Kolff designed the Kolff Twin-Coil dialysis machine based on a three times higher urea extraction rate than other dialysis machines at the time. Clinical assessment was demoted and the rate of urea removal became the basis of adequate dialysis. This was fully entrenched in American dialysis practice patterns when the National Cooperative Dialysis Study (NCDS) led by Peter Bent Brigham Hospital Nephrology (PBBH) trained Edmond G. Lowrie, MD declared that TIME was not an independent factor of dialysis outcomes. 

This was not an isolated debate or event. In fact, Willem Kolff had challenged Belding Scribner's claims of improved outcomes with longer, slower and more frequent (Three times a week instead of twice a week) dialysis strategies for decades. In 1960. Bernard Charra recorded one of Kolff's challenges to Scribner in the early 1960's:

Is Kt/V Urea a Satisfactory Measure for Dosing the Newer Dialysis Regimens?

Charra, B. (2001) Seminars in Dialysis, 14: 8-9. https://doi.org/10.1046/j.1525-139x.2001.00003.x

A Relevant Case Report

"In the early 1960s, during an American Society for Artificial Internal Organs (ASAIO) meeting, Dr. Kolff challenged Dr. Scribner, who was claiming better success with long, slow dialysis, to accept one of his patients for a trial dialysis period. Dr. Scribner accepted and the patient's response was amazing--reversal of uremic neuropathy, return of appetite, and real weight gain. Since the weekly removal of urea was roughly the same with 2 × 6 hr/week coil dialysis (employed by Kolff) and the 2 × 12hr/week Skeggs-Leonard system, and both systems used the Dupont 300 membrane, this response must have been due to increased dialysis time with an accompanying increase in toxic middle molecule removal."

By 1981, much of what Scribner and those in his "school" of thought on dialysis strategies had perfected, had been long forgotten removed from clinical practice after the initiation of the 1973 ESRD program. The Boston, for-profit brick and mortar dialysis system especially with National Medical Care Inc. and their PBBH trained leaders, changed the standard of care to short, thrice weekly dialysis sessions. Clearance of uremic symptoms fell to business model protocols, and profit maximization. The debate between Kolff and Scribner now became a national debate with the for-profit model prevailing:

ASAIO History Committee

"Many of the lessons taught by the Seattle team, especially the importance of long dialysis times to combat hypertension, fluid overload and cardiovascular disease, were forgotten as commercial priorities, supported by a wrong-headed emphasis solely on small molecule removal, led to cranking up of dialyzer urea clearance while shortening dialysis time. Much is now being relearned. Time on dialysis is in itself of great importance in the survival of dialysis patients. "There is nothing new under the sun, everything has been done before!"

This is an abbreviated background to the alleged reasons for conducting the National Cooperative Dialysis Study. By 1981, the lessons of optimal, long, slow dialysis, focussed on clearance of middle molecules had been replaced by short, fast and violent dialysis sessions where fluid removal was rapid and the urea was the solute that this dialysis model emphasized. Gone was the focus by Scribner on clinical outcomes and the dose of dialysis needed to achieve alleviation of all uremic symptoms including HTN and uremic neuropathy. The entire purpose of the NCDS as they stated was to find an "objective" measure of the dose of dialysis.

EFFECT OF THE HEMODIALYSIS PRESCRIPTION ON PATIENT MORBIDITY
Report from the National Cooperative Dialysis Study*
E. G. LOWRIE, M.D., N. M. LAIRD, PH.D., T. F. PARKER, M.D., and J. A. Sargent, Ph.D.

"PHYSICIANS who prescribe hemodialysis therapy have long been confronted by the difficult problem of how to determine an appropriate "dose" of dialysis for individual patients. In clinical practice, most patients in a dialysis program undergo treatment for similar lengths of time and with dialyzers that have similar performance characteristics. The needs of individual patients are often not considered or, if they are considered, are judged more by clinical impression than by quantitative measures to guide therapy. Any difference between treatment regimens is usually influenced more by different needs for removal of fluid than by different metabolic needs; individual requirements for solute removal are often ignored.

The National Cooperative Dialysis Study (NCDS) was initiated because of the perceived need to develop a quantifiable definition of adequate long-term dialysis treatment within the domain of current clinical therapies."

Just starting with the alleged need for this study, many questions arise when you understand the history of the debate between Scribner and Kolff on Urea vs Middle molecules, longer and slower vs quick removal of urea, and relief of all uremic symptoms including HTN and uremic neuropathy. As a medical student, internal medicine resident and throughout my 17 years of clinical practice, one mantra I heard repeatedly was "treat the patient, not the labs." We must remember the challenge by Kolff to Scribner all those years ago where Scribner doubled the TIME of dialysis treatment and had relief of neuropathy and lean weight gain, yet, the Urea removal was exactly the same. Would the URR or the Kt/V predict this improved outcome, or was instead the focus on TIME and middle molecule removal the likely reason for the difference?? Quantifiable laboratory outcomes can never predict the full clinical picture as we noted over twenty years later with the HEMO study. (The right answer to the wrong question.) But, the Scribner approach of focussing on clinical parameters and treatments based on relief of all uremic symptoms has succeeded in predicting outcomes and is a reproducible model of care as seen especially in Tassin, France for over 30 years.

In my opinion, the opening two paragraphs of the National Cooperate Dialysis Study is in itself a study of Freudian psychiatry of confessed guilt of ignoring patients clinical status and focussing instead on the laboratory assessment as the "objective" measure. Lest we forget as physicians, there are subjective and objective aspects to a patients physical and history examination. Elements of the objective examination include blood pressure, evaluation of fluid status for which Belding Scribner used bioimpedence along with clinical status, and the most objective was improvement of uremic neuropathy as measured objectively with nerve conduction studies. Both of these methods are still in use today over 60 years after it was Scribner's standard of care measurements on "adequacy of dialysis dosage." Yet today, nephrology pronounces to patients daily, "well your labs look good," while the patient is floundering with HTN, muscle wasting and progressive cardiovascular decline. 

Nephrology needs to remember their history of dialysis adequacy first being relief of all uremic symptoms which is only possible with "adequate TIME." This makes the entire NCDS study, in my opinion, a perverse, unwise study and also a study completely bereft of any meaningly improvement that could ever be expected by focussing solely on an easily removed, small molecule called urea. In addition, there was abundant evidence prior to the beginning of this study that urea kinetics could never improve dialysis care in the US. The years following the NCDS and the beginning of Kt/V from the "mechanistic" evaluation of the NCDS in 1985 showed not improvement, but worsening death and suffering in dialysis units where nephrologist focussed on an easily manipulated, "objective" measure of dialysis called the Kt/V. 

In my opinion, the study should never have taken place and it certainly deserves no hallowed treatment as the "first" RCT in dialysis, "setting the standards," as it does today. And indeed, the NCDS has set the standards of care for dialysis in America, but is that a standard of death and suffering that it has established with maximal profits? We have taken a noble experiment, given it to the for-profit dialysis industry and turned it into an instrument of cruelty for far too many patients.

It is time to "objectively" evaluate the NCDS and show its inherent flaws and outcomes that are in the end result, perverse and cruel, in my opinion. It is not a standard of health and restoration, nor can it ever be.

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."

 

A Monopoly, A Duopoly, And a Free Market: Which Economy Provides "Optimal" Dialysis?

Two companies, Fresenius and DaVita, control over 80% of the US in-center Hemodialysis market, and Fresenius further has "monopolistic" control of the US Home Hemodialysis market since it's acquisition of NxStage Medical in 2019.

FMCNA COMPLETES ACQUISITION OF NXSTAGE MEDICAL

WALTHAM, MASS. – Feb. 26, 2019 – Fresenius Medical Care, the world’s largest provider of dialysis products and services, has successfully completed the acquisition of NxStage Medical, Inc. (NxStage), following approval by antitrust authorities in the United States. . .

. . . “The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality,” said Rice Powell, Chief Executive Officer of Fresenius Medical Care. “By combining NxStage’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”

However, I strongly protest Fresenius CEO Rice Powell's assertion that the acquistion of NxStage Medical Home Hemodialysis program "enhances" patient's choices of treatment modality. Since this acquisition, other Home Hemodialysis machines vying to enter this promising market such as Outset Medical Tablo and Quanta have met stiff competition not only from Fresenius, but also paradoxically, with the joint efforts of Fresenius and DaVita together trying to establish another duopolistic control of this market as well.

DaVita Kidney Care Expands Use of NxStage Home Hemodialysis Machines from Fresenius Medical Care

New Agreement Supports Efforts to Empower More People Living with Kidney Failure to Choose Home Dialysis

WALTHAM, Mass. and DENVER – March 23, 2021 – Fresenius Medical Care North America (FMCNA) and DaVita Kidney Care today announced an expanded agreement to provide home dialysis technology—including NxStage home hemodialysis (HHD) machines, dialysis supplies, and a connected health platform—to DaVita patients across the United States. The agreement supports both companies’ goals to empower more patients to choose home dialysis, which can provide a higher quality of life for people living with chronic kidney failure*1.

“For patients choosing home dialysis, it can mean more freedom and also active participation in their care, which is why we’re always looking for new solutions that ease the burden on our patients,” said Keith Hartman, group vice president for DaVita home modalities. “We’re expanding our use of NxStage home hemodialysis machines that have invaluable remote capabilities and connectivity for our patients. By transmitting treatment information, we hope to help identify irregularities and prevent avoidable complications, thus supporting patients’ desire to stay on their treatment of choice longer.”

Empowering patients to develop "independent" control of their own treatments is always a step in the right direction, but is NxStage the best machine available today to provide for that independence? Certainly, for myself, the NxStage System One or the new NxStage VersiHD, while granting it is the only portable dialysis machine widely available in the US today, does have limitations such as a fixed sodium of 140 mmol/L. In my case, this caused sodium loading for which I no longer tolerate the fixed sodium of 140 mmol/L  There came a point that I had to change to the Fresenius K@Home Dialysis system which has flexible sodium, bicarb and other settings allowing individual adjustments. 

Today, we have the Outset Medical Tablo Home Hemodialysis machine which has flexible settings of sodium (130 mmol/L to 145 mmol/L), bicarb and TIME that, in my opinion, will accommodate more patients than the NxStage machine . This provides a better match of sodium levels, which, also in my opinion, is a key to  help reduce HTN and LVH in longstanding dialysis patients. Reducing dialysate sodium levels helps decrease the sodium gradients during dialysis. NxStage, with its fixed sodium levels is relatively contraindicated in my case with the loss of residual renal function over the last 5 years and the development of high output cardiac failure from my high flow, brachiocephalic fistula. This one issue ended my 6 years of treatment with the NxStage System One in 2015 due to their fixed sodium levels in all their dialysate products available. (Note: Fortunately, plication of my fistula anastomosis in 2022 of the first 3 cm has completely reversed my High Output Cardiac failure and "right-sized" my fistula, but I still remain very sodium sensitive.)

Scribner showed in his first patient, Clyde Shields, that HTN was related to an expanded extracellular space size and controlled BP with sodium reduction and sufficient UF. There are, however, clinical situations where cardiac ejection fractions result in low pre-dialysis BP and metabolic effects of high, intracellular sodium levels contributes to hyponatremia in the plasma. Many approach this combined low EF, low BP and low sodium with a positive sodium gradient to prevent intradialytic hypotension. In reality, that only perpetuates the expanded extracellular space volume, thus continuing the cycle of hyponatremia and low BP with poor outcomes from excessive intradialytic UF.

Scribner warned about this many times being caused by not only expansion of the extracellular space but also the for-profit motivated short TIME of dialysis in the US. Scribner further believed and showed that TIME was a necessary component of controlling HTN. Bernard Charra in Tassin, France, reproduced Scribner's long and slow dialysis protocol for over 30 years with excellent BP control using the Drug Free Dry Weight method. 

However, despite the clinical benefits of the flexibility of the Outset Medical Tablo over the NxStage, it has found poor market penetration which, in my opinion, is in large part due to the "undue" influence of the Home Hemodialysis "monopoly" reigned over by Fresenius through NxStage ownership. 

Contrary to the Home Hemodialysis and In-center Hemodialysis market controlled by monopolies and duopolies, is the truly remarkable free market competition of the Acute Kidney Injury market in hospital based ICU's. Here, we see not only market competition, but all innovative dialysis strategies giving providers full access to all possible combinations of TIME, Frequency, Convection modalities and high flux artificial kidneys. It is a market that is not controlled entirely by Nephrology alone, nor large dialysis organizations. Here Outset Medical with their Tablo dialysis machine is making popular headway in the acute renal treatment market. 

In fact, other new dialysis machines such as Quanta are entering the US market through the ICU acute care market to gain acceptance. Although Tablo has had FDA warnings on marketing info that included unapproved 24 hour data to challenge the CRRT market, Tablo is well poised to dominate the market of SLED, SLEDD, SLEDD-f and CRRT with its quick, simple set up and small size compared to the RO systems. But for patients, economic competition leading to provider freedom in the ICU is giving patients the best choices, the best options and the best outcomes possible that dialysis can offer. In the ICU, there are many US and international companies providing doctors true choice in dialysis modality and a very interesting competition between critical care doctors and nephrologists on who controls this market.

This same free market competition is completely lacking in both the in-center and home hemodialysis markets. We find here instead, a monopoly in Home Hemodialysis and a Duopoly with in-center dialysis, that stifles physician and patient control over treatment paradigms. Today, Fresenius and DaVita have overt control over dialysis prescriptions, machines, supplies and protocols. Fortunately, in the Acute Kidney Dialysis Market, freedom is still a word you can use truthfully and appropriately, when we consider the freedom that critical care doctors, ICU nurses and nephrologists have because of economic competition in the Acute Kidney care realm of dialysis in the ICU.

While it may be too late to positively impact free market competition in the chronic dialysis population short of anti-trade actions by the FTC and the DOJ, we should cherish the freedom found in the ICU for dialysis care. It is easy to recognize the cognitive dissonance between the hundreds of academic articles debating dialysis protocols that deny TIME as an independent factor of ESRD, dialysis mortality in chronic kidney care ICU dialysis protocols. The ICU docs understand well that longer, slower and more frequent is the winning dialysis protocol for patient survival. Perhaps, some of the nephrologists advocating that TIME and Frequency do not impact mortality will one day carry over what they learn in the ICU to their chronic patients suffering the effects of "for-profit greed" that leads to Death and Deficiency in Kidney Treatment across this nation. 

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.

Prop 23: Patient Safety or Unionization Blackmail?

It is very infrequently that I side with the dialysis industry against patient initiatives to increase safety. Yet, that is the ironic position I find myself today in accord with both Fresenius and DaVita standing against CA Prop 23.

California Proposition 23, Dialysis Clinic Requirements Initiative (2020)

What would this ballot initiative require of dialysis clinics?

The ballot measure would require chronic dialysis clinics to:^[1]

• • have a minimum of one licensed physician present at the clinic while patients are being treated, with an exception for when there is a bona fide shortage of physicians;
  • report data on dialysis-related infections to the state health department and National Healthcare Safety Network (NHSN);
  • require the principal officer of the clinic to certify under penalty of perjury that he or she is satisfied, after review, that the submitted report is accurate and complete; and
  • provide a written notice to the state health department and obtain consent from the state health department before closing a chronic dialysis clinic.

The ballot measure would also state that a chronic dialysis clinic cannot "discriminate with respect to offering or providing care" nor "refuse to offer or to provide care, on the basis of who is responsible for paying for a patient's treatment."^[1]

In an opinion journalism piece on Prop 23, Politico correctly characterizes this initiative as a ploy for forcing unionization in CA dialysis centers:

California's $100M dialysis battle comes with ancillary benefits for labor union

“The whole idea of using non-traditional tactics to achieve greater leverage in unionizing has been around for years,” SF State’s Logan said. “SEIU, in particular, is one of a number of unions that have used corporate campaigning very extensively and quite successfully over a number of years.”

SEIU-UHW, since 2012, has filed some 23 local and state initiatives. In recent years, they’ve launched a flurry of measures, targeting a number of California hospitals to limit prices and impose executive salary caps, though many failed to qualify or were abandoned.

While there are many clinical, political, ethical and legal issues that are unsettling in the dialysis arena, Prop 23 is not the fix for what ills this industry. It is of benefit only to the unions who are proposing these untenable restrictions and impositions. Obviously with a nationwide shortage of nephrology fellows in training, the provision of placing a physician on site while patients are in the treatment area is simply unnecessary, poor utilization of the limited nephrology providers and are simply a blackmail tactic on the part of SEIU to force unionization in dialysis centers. This would paradoxically decrees funds available for patient care given the fixed budgeting with Federal caps on Medicare payments under the Dialysis Bundle.

Further, even ICU's do not require on site physician coverage in the ICU itself. It is the well trained and very capable ICU nurses that are present at all times with doctors available by telephone 24 hours a day and backup coverage with physicians in the ER and hospitalists to assess and manage acute emergencies. Even here, an attending physician on site is not required or necessary. Dialysis patients are by and large much more stable on any given treatment day than ICU patients. Further, the regulatory requirements for crash carts in dialysis centers are remarkably deficient and do not have standard code medicines present in hospital crash carts or even clinic crash carts we had at Kaiser which were complete. Having a physician on hand in a dialysis center is even more absurd since they would have to wait for paramedics to arrive to have access to even basic ACLS medications used to abort common heart arrhythmias or treat acute myocardial infarctions. Doctors on site could provide no more advanced care than the nurses or technicians already on site.

In addition, health reporting mandates are already part of Medicare and state health guidelines. 

I would urge dialysis patients in CA to vote NO on Prop 23 but continue to seek true reform and innovation in dialysis which is desperately needed in this industry. This is neither true reform nor innovation. It is exactly as Poltico correctly states, a ploy by these powerful unions to force the dialysis providers to the negotiation table.

Noncompliance: A Word that Kills

In February 2007, I entered the arena of in-center hemodialysis as a brand new hemodialysis patient. Despite nearly 20 years of experience in hospital and clinic settings, I soon found that it was indeed a brave new world I had entered which was completely foreign to anything I had experienced as a physician. Despite my intention of one day performing home hemodialysis as my preferred modality, I had to submit to the regimented perils of usual care hemodialysis giving my care over to nurses and technicians that I soon learned were overworked and underpaid.

But the biggest culture shock was the manner in which choices were made for me and often without any input from my own wishes. Any patient experiencing the shock of a devastating medical condition can be overwhelmed by the changes in their life and mine were literally overnight going from my clinic the day before to their clinic the next day. Fortunately, I had several years of slowly progressing chronic kidney disease to come to terms with the eventual need for renal replacement therapy. Interestingly, I didn't struggle with that aspect, but the loss of freedom and choice soon became apparent from just obtaining a "seat" in the unit. Most appointments prior to this, I was given choices of times and dates to accommodate my own schedule. Here, I was told when to arrive, what days to come and where to sit.

By God's grace, my technician had gone from being my own patient to my technician overnight as well. She is a talented and dedicated health care professional who mastered the tasks of dialysis with compassion and competence as few other techs have. I was pleased to later learn that she had proceeded to an RN program to complete her education. Fortunately as well was our prior relationship of trust and respect so that she felt comfortable listening to my concerns. My first decision that she agreed completely was to limit my ultrafiltration (UF) from the very first day to only 500 ml since I still had robust residual urinary function. I did not understand that day we had violated an antiquated minimum UF rule of 300 ml/hour of dialysis. Yet it made no sense to pull 1200 ml when I had to struggle to make it through that 4 hour session before I got up and went to the bathroom. In fact, there was more than one occasion in my early days of dialysis that I had to pause the treatment to relieve my bladder. That one decision turned out to be an important survival choice which studies confirmed at least a decade later. High UF rates damage residual renal function.

Unfortunately, my wonderful first technician left only a few months later after other techs started vicious and unfounded rumors about her. My safety net collapsed and the real arena of control and retaliation soon followed not even prevented by "MD" after my name. My UF goals of only 500ml and the urban myth of a minimum UF rate persisted and many times over the years, nurses forced me to accept the minimum UF rate and receive 400-600 ml of saline in support. I finally put this to a rest only a year ago by a doctor's order but that still caused one nurse to give me an extended lecture on why it was wrong. After nearly 14 years of hemodialysis, my UF last night was once again, 500 ml for 5 hour session at a UFR of 100 ml/hr and 0.1 kg less than my end dialysis weight two days before. But this took more than a decade to get as a standing order when it should have been done a priori given my lack of significant interdialytic fluid gains even with the loss of most of my residual renal function the last few years.

For such a minor issue to persist for well over a decade despite medical studies showing it is an urban myth, and my own personal situation of not needing even the "minimum UF" settings on most sessions, that was a minor nuisance turned into a major point of contention by all too many dialysis nurses and technicians. The label of me being a "difficult" patient surprised me since it had been my practice and my professional ethics to honor informed decisions by my patients when it was medically indicated or not prohibited. 

The real culture shock which took only a short time to understand was the lack of respect for patient autonomy and the nearly complete lack of informed consent on various choices. (here, and here) One study in 2005 showed that only 12% of patients heard of home hemodialysis as an option before starting renal replacement therapy. Paternalism rules in the dialysis arena from the nephrologist down to the dialysis techs. Further, this culture fuels retaliation I believe much in the same manner psychologically as the Stanford prison experiment produced harsh treatment and control by the the student "guards." Autonomy and choice are squelched by the ever present rushed schedule and lack of time for individualized care from harried techs.

An example of this is when I chose to forgo erythropoietin (EPO) early in my dialysis journey after I learned about the many risks with little if any benefit since my Hb was near normal without any Erythropoiesis-stimulating agents (ESA) support. The first day I declined EPO, the head nurse was very upset with my decision, but the very next day, the FDA released a black box warning and my decision to forgo EPO presaged the new guidelines by one day. Nevertheless, a year later, in 2008 during my first trip to visit my mother in Cape Cod, the clinic director introduced herself with the following statement, "So, you refuse EPO." This after the black box warning and having a Hb over 12.5 without it.

Whenever I declined a treatment or a procedure, it was documented as "patient refuses." Their obvious documentation practices  deliberately made all of my well informed decisions appear to be "noncompliance." When ever I saw that they documented my choice as patient "refuses," I corrected them and stated, no, that is not true. I decline that treatment by a very informed choice based on my study of the issue at hand. Most patients do not have a medical degree and the ability to readily research issues for their own benefit, although a surprising number of my own patients did just that and brought me articles I was not aware of adding to my own education on select conditions.

But this adverse documentation has a purpose in the dialysis industry to justify involuntary dismissals for alleged noncompliance. Involuntary dismissals are a death sentence brought on often by only asking a nurse or technician to wash their hands before treating them.  While the overwhelming number of dialysis professionals are caring, compassionate and competent providers, I have unfortunately encountered far too many who would have fit in well with the SS more so than with Florence Nightingale. In 2018, I became the object of such a cabal of technicians, nurses and a physician who on April 16, 2018 dismissed me involuntarily from my home dialysis program. My doctor claimed I had "failed" home hemodialysis after the technicians claimed that they could not fix what ever was wrong with the machine causing a horrific taste and associated symptoms during dialysis.

Yet, the machines that these techs claimed could not be fixed are the same exact RO and 2008K@Home machines that my current technician did rebuild and restore to excellent function. My two years of forced in-center treatments came about in part by a campaign to show I was not only noncompliant, but also unable to tolerate home dialysis treatments implying in many ways I was either deficient psychologically or incompetent to run the machine. I am grateful that the atmosphere changed greatly after President Trump's executive order in 2019 to increase home dialysis availability and use in the ESRD population. I doubt I would have returned to home hemodialysis without his intervention.

During my fixed in-center schedule from April 2018 until May of 2020, I missed many family outings especially with my grandchildren such as piano recitals, school outings, and family dinners. This is of minor consequence compared to an in-center dialysis patient who is left with no recourse but emergency dialysis from the ER a few times a month instead of thrice weekly. It is a painful, and slowly agonizing death sentence for the alleged "crime" of noncompliance with the dialysis nurses and administrators acting as their accuser, prosecutor, judge and jury. The ESRD networks often rubber stamp these dismissals leaving the patients with no recourse unless they can get placement with another dialysis. But the dark secret of dialysis centers is blacklisting the dismissed patients preventing transfer to any other unit.

This in part happened in my case as well. The week before I was dismissed, I sought a transfer to another physician at another unit in Spokane WA where I trained on the Baby K. On Friday morning, my doctor I was transferring from called me to ask me if I was going to come in for my monthly clinic visit the next Monday morning. I told her yes and it was my plan to thank her for all she had helped me with over the prior three years and part on a professional and amicable level. She contacted the doctor I was attempting to transfer to who had at one point been a colleague of hers in another medical group. When I came in Monday morning, I thanked them for all that they had done. Then my doctor informed me that the other doctor would not accept me as a new patient but he did agree to a second opinion. All this occurred with the other doctor never once contacting me directly. She further stated that since they could not detect or find the offending issue with my dialysis machines, that I had "failed home hemodialysis" and she was transferring me back to in-center "permanently" the very next day.

I was given no choice, no recourse and they pronounced my sentence. I still acted in a professional manner as a physician and I still thanked her for all that she had done for me the last 3 years. I parted peacefully, cordially and professionally despite the obvious injustice of what had just occurred.

The next two years were difficult and I am still not returned to the level of function I had before this occurred. At 62, it may in part simply be the aging process, but there is no doubt that my body took a toll going from 22 hours of dialysis weekly to 12 to 15 hours a week in-center.

The word noncompliance is tossed around in medical circles as if it is the greatest of evils, yet in my instance, it was simply my own choices, my own informed decisions that was forbidden in this arena of dialysis. And I do call it an arena because anyone that wishes to maintain autonomy, independence and informed choices must become a defensive soldier able to defend those rights themselves, through knowledge, to keep those civil rights so easily dismissed and trampled by this industry.

It is with great sadness that I contemplate the number of patients who have succumbed to this sentence of judgement, this death sentence imposed often for no reason other than the power and control of people imposing their will on others helpless to oppose them. Yet, this is most often a silent suffering only known to those close to these patients. Government statistics are sparse at best. It is time that this practice is halted and true patient rights are respected once again in the dialysis unit.

Belding Scribner commented on his "Nobel experiment" that was hijacked by greed and profiteering. His close friend  Christ Blagg, MD eulogized him after his death in the prominent renal journal CJASN:

Belding Hibbard Scribner—Better Known as Scrib

Christopher R. Blagg

CJASN December 2010

"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 legislation 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 organizations. 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."

May it be soon that we return to the ideals of Dr. Scribner's "noble experiment" and see the fruit of his dedicated contributions and donations to all that suffer from renal disease. It is time to overcome greed and cold hearted adherence to the bottom line and instead place relief of suffering and restoration of health and life from this wonderful technology that sustains me today. It is time to see that dialysis is also and in many ways most importantly, the true gift of life.

NxStage Aluminum Contamination: Is Rockwell Medical Inc. at Fault?

By Peter Laird, MD

On May 14, 2014, NxStage Medical Inc. issued a voluntary FDA recall of 140,000 to 150,000 concentrated dialysate SAKs from elevated levels of Aluminum in lots manufactured from April 2013 to February 2014. NxStage produces the only FDA approved portable home dialysis machine and is a popular choice for many patients who wish to maintain an active and independent lifestyle.

To date, NxStage has not revealed details on how this significant failure occurred. I recently discussed the aluminum event with a high ranking NxStage officer who stated that they are constrained by FDA regulatory provisions that prohibit full disclosure until the FDA investigation is complete.

NxStage outsources all of their lactated dialysate products to two companies, PiSA, the largest pharmaceutical group in Mexico and Rockwell Medical Inc. which signed an agreement with NxStage on March 8, 2013 to produce concentrated dialysate. Shortly after this agreement, the first contaminated lots of concentrated dialysate contaminated with high levels of aluminum appeared in April 2013. Many patients allege that Rockwell new to the NxStage lactated dialysate manufacturing process is the likely source of the contaminated concentrates.

Rockwell Medical Inc. produces mainly bicarbonate dialysate in competition with Fresenius dialysis products for the American dialysis market. Incorporated in 1995, my review of  Rockwell public records reveals that this company has limited experience with lactate dialysis products which are produced in a  complex process through fermentation.

The largest producer of lactate products in the world is Purac which has exceptionally low tolerances for aluminum and heavy metals. Purac manufactures pharmaceutical grade lactate with a max tolerance of 0.1 ppm (0.11 mcg/L) and is considered the gold standard producer of lactate products through out the entire world. In an extensive review of NxStage, Rockwell and PiSA public records, none of these documents listed the source of their lactate products, nor could I find direct agreements in public records with Purac. In addition, Rockwell has not responded to date to my queries for comments on this event.

While NxStage will not confirm that Rockwell is the producer of the tainted product, circumstantial evidence points directly to Rockwell as the source. 

Should the FDA investigation conclude that Rockwell Medical is the source of the NxStage Aluminum contamination, investor relations may suffer in light of what many consider a solid future for this company nearing completion of a New Drug Application for their iron dialysate product, Triferic.  It would also mark continued safety and quality concerns that has haunted Rockwell over the last several years.

In 2008,  state inspectors at a South Carolina Rockwell plant found major safety and manufacturing violations in follow up to multiple customer complaints. (here) In 2009, thousands of cases of shipped dialysate was recalled after finding excessive levels of bacterial growth. (here and here)

In 2012, Dr. Richard Yocum,  a former Rockwell senior vice president in charge of Rockwell's Triferic research alleged SEC reporting violations and fraudulant claims for their drug in development in a wrongful termination lawsuit. (here)  Triferic is expected to soon enter an annual 700 million market for iron replacement. Although Rockwell prevailed in this lawsuit, the judge limited his ruling to the narrow question of whether Rockwell had the right to terminate Dr. Yocum's "at will" employment. (here) A private law firm initiated a secondary investigation into these allegations in 2013. (here) 

With the ready availability of high grade, ultra-pure lactate products from Purac with levels at a fraction of those found in the NxStage lactate concentrated dialysate, the ensuing FDA investigation needs to uncover all of the details of this preventable event. However, should Rockwell Medical Inc. become the focus of this active FDA investigation, many will rightly, I believe, question their dedication to quality products.

In light of the impending FDA approval of Triferic after exhuberant results in their recent PRIME study, I myself will take the advice of a trusted colleague who once told me, don't be the first doctor to prescribe a new drug, nor the last. Until we have extensive evidence from Triferic's post marketing results assuming it will soon be approved, I certainly will not be one of the first patients seeking this companies new drugs.