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."

 

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.

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.

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.

Is Daily Dialysis Dangerous?

By Peter Laird, MD

Kidney International recently published a study on daily dialysis alleging worse outcomes for patients on daily in-center dialysis as compared to conventional in-center thrice weekly dialysis. The authors noted that this was a different outcome than prior observational dialysis studies on more frequent and longer duration strategies.

A multinational cohort study of in-center daily hemodialysis and patient survival

Those receiving daily hemodialysis had a significantly higher mortality rate than those receiving conventional hemodialysis (15.6 and 10.9 deaths per 100 patient-years, respectively: hazard ratio 1.6). Similar results were found in prespecified subgroup and sensitivity analyses. Unlike previous studies, we found that in-center daily hemodialysis was not associated with any mortality benefit. Thus, decisions to undertake daily hemodialysis should be based on quality-of-life improvements, rather than on claims of improved survival.

The researchers conclude that their study is the most conclusive and best evidence on mortality of daily dialysis in-center. However, simply reviewing their methods and results brings into question several areas of concern with this latest publication.

First, the most obvious data needed to compare the patients in this cohort is the clinical indication for why they were on daily dialysis in the first place. While daily dialysis at home is a utilized in the United States and more widely in Europe and Australia, even in those nations, daily dialysis in-center is not ordinarily utilized without specific clinical reasons. In America, many patients who are failing on conventional thrice week therapy often advance to four times a week treatments or more as a rescue strategy. Incredibly, this study failed to gather any data on why patients were on daily dialysis in-center and they indicated informally that rescue may have been an operative indication:

A multinational cohort study of in-center daily hemodialysis and patient survival

Most importantly, we do not have any information as to why daily hemodialysis was prescribed to individual patients in this study. If daily hemodialysis was prescribed as a ‘rescue’ option, patients selected for this therapy may have been sicker than those maintained on conventional dialysis. Some French patients may have been selected in this way (personal communication, CC and RG).

In addition, the short daily group had twice as many grafts compared to the conventional group and 30% of the short daily patients had no access data at all. Given the significant risk of death from AV grafts compared to fistulas, this could lead to significant confounding bias. Other data lacking in this study included no documentation of residual renal function, severity of co-morbid disease or socioeconomic factors, all of which are known predictors of survival. 

In addition, a secondary analysis of the FHN short daily and nocturnal studies by the same lead author focused on access issues speaks negatively of daily dialysis in yet another study:

Risk of Vascular Access Complications with Frequent Hemodialysis

In conclusion, frequent hemodialysis increases the risk of vascular access complications. The nature of the AV access repairs suggests that this risk likely results from increased hemodialysis frequency rather than heightened surveillance.

Many are already discouraged from recent studies and negative commentaries on daily dialysis. Others that know and understand the benefits of daily dialysis and will simply ignore this latest study:

Despite the risks of more frequent dialysis, I will continue, thank you

Studies like this, in my humble opinion, do more harm than good. Some doctors would potentially be put off by this risk of access problems and not recommend more frequent dialysis for their patients. The benefits of the modality are mentioned only in passing and the entire focus of the paper is access problems. This may be all right when you look at it purely from a statistical perspective. But I am really worried that the paper might have just taken daily dialysis off the menu for some people about to get onto dialysis.

That is sad, indeed.

I agree with Kamal Shaw except in one regard. I don't believe that this author in two separate studies has truly proven that more frequent hemodialysis has higher complications and higher mortality. Yes, indeed, that is the conclusions of her two articles, yet can we discount all of the positive articles that have come before? A noted deficiency of the FHN articles is that they did not report whether they used constant site cannulation, better known as buttonhole cannulation which has a lower risk of stenosis and aneurysm, but may increase infections in an in-center setting.

Blood flow rates were not noted in either of these studies as well. Unfortunately, a common practice of many dialysis nurses with short daily dialysis is to significantly increase the blood flow rate to the maximum allowable levels. This is a known cause of access complications that is entirely preventable, but many nurses and patients increase the blood flow rate to improve solute clearances and reduce the time of dialysis. Unfortunately, this data is lacking as well.

I have now completed six full years of hemodialysis and by God's grace and mercy, I have yet to have any access complications. I am now completing nearly 4 years on continuous home hemodialysis with 5-6 cannulations each week. More than once, dialysis professionals have commented that my fistula is the "prettiest" fistula that they have seen.

It is clear when you evaluate the causes of access failure and complications that technique is paramount to assuring reduced adverse events. Taking care of an access requires time that most dialysis technicians simply do not have. It takes me about 20 minutes to remove my scabs, control any bleeding and place betadine, let it dry and remove the excess with alcohol pads prior to inserting my own needles. Most techs simply apply the disinfectant, wipe off any excess and stick a needle into the fistula in less than a minute for both, perhaps two minutes in some cases.

Buttonhole cannulation does not lend itself to that type of rapid access cannulation. What puzzles me the most is the number of nephrologists who actively seek to prove daily dialysis inferior. Is it not time that we enter the rest of the realm of medical practice where we seek to avoid complications, improve procedures and improve outcomes? Sadly, in my opinion, much more effort is generated to discouraging patients from seeking home daily hemodialysis than promoting this wonderful modality.

In my opinion, having God's blessing of no complications from my dialysis to date, frequent daily hemodialysis is easy and safe to administer. I have no doubt that the technical difficulties that in-center patients suffer causing many of these complications are easily correctable but they must have time to do so. It never ceases to amaze me how little the so called dialysis professionals in-center understand about home hemodialysis and commonly used home dialysis techniques.

The better question to answer and promote is why is it that some patients can secure their access without any significant complications for decades, yet some in-center patients suffer frequent episodes of these "common" complications. It is with great regret that I have come to understand that a large majority of "common" dialysis complications are in reality iatrogenic in nature. Access complications appear to be no different.

I would hope that the story of dialysis will one day include a marvelous period of reawakening of how to do things better. The intensive care central line infection rates ravaged patients throughout America until a wise doctor in Johns Hopkins realized that we could improve the technique of inserting and caring for central lines. (here and here) Today, using a simple protocol for all of these procedures, infetions of a central line is now consider a "never" event since it should never occur. This is a prime example of improving the technique of a procedure to eliminate "common" infections which in the end analysis were iatrogenic in nature.

The dialysis industry has yet to embark on the same quest of excellence that our colleagues in other specialities have embraced decades ago. I understand that my risk of infection and complications is quite low even with daily dialysis due to adherence to strict techniques to eliminate potential complications. I am not alone in that many home hemodialysis patients have never had any major complications for years either. Is it not time to start looking at how to prevent complications instead of spending so much time and energy trying to denigrate optimal dialysis?

Perhaps I am simply asking too much but I don't believe so. With my understanding of the benefits of daily dialysis, I wonder when will the American nephrology community learn how to best apply simple techniques to routine dialysis practice that in the end is not costly at all and will save patients suffering, death and pain while reducing secondary treatment costs substantially.

Yes, daily dialysis in the hands of current technicians may indeed be dangerous. Daily dialysis in my hands is easy, safe and effective by strict protocols much in the same fashion as the central line bundle. I wish I could be there for every single patient to apply my own tried and true hygiene and cannulation techniques I have learned from many wise people such as Stuart Mott, but alas, I can't nor can Stuart. Why is it that select individuals can perform these procedures with minimal complications, yet the industry in general cannot? I believe I know the answers to that question, but the industry is not even asking that question. Perhaps that is the biggest problem of all.

Optimal Dialysis: Forty Years of Hope and Despair

By Peter Laird, MD

Shortly after the onset of hemodialysis coming to the forefront as a viable life saving procedure in the 1960's, researchers hypothesized that daily dialysis would be the optimal treatment modality for artificial renal replacement therapy. Later, Dr. Carl Kjellstrand provided the theoretical physiologic justification for more frequent and longer duration hemodialysis with the "Unphysiology Hypothesis" in 1975. 

The Rationale for More Frequent Hemodialysis – ‘Unphysiology’ 

In the early 1970s, Kjellstrand et al. [12, 13] investigated factors related the untoward effects of dialysis. They showed that large fluctuations in body weight, electrolytes, osmolality, and urea concentration were more important with respect to morbidity than concentrations of small uremic toxins or middle molecules. This led them to formulate the ‘unphysiology’ hypothesis which suggested that wide swings of solutes and fluids in the body were significant causes of morbidity in dialysis patients. Daily or continuous dialysis would more closely mimic the function of the native kidney by reducing the magnitude of solute and fluid oscillations and so would be expected to be superior to the usual intermittent dialysis regimens.

Interestingly, despite the long standing skepticism of quotidian dialysis protocols by the American nephrology community, researchers developing new dialysis technology such as the implantable artificial kidney, Victor Gura's WAK and other renal replacement devices in development all are in agreement with Dr. Kjellstrand's Unphysiology theory of more frequent and longer duration therapies. (here) Interestingly, even Wikipedia understands the underlying physiologic basis for developing these new renal replacement devices:

Need for a bioartificial kidney

Over 300,000 Americans are dependent on hemodialysis as treatment for renal failure, but according to data from the 2005 USRDS 452,000 Americans have end-stage renal disease (ESRD).^[2] Intriguing investigations from groups in London, Ontario and Toronto, Ontario have suggested that dialysis treatments lasting two to three times as long as, and delivered more frequently than, conventional thrice weekly treatments may be associated with improved clinical outcomes^[3] Implementing six-times weekly, all-night dialysis would overwhelm existing resources in most countries. This, as well as scarcity of donor organs for kidney transplantation has prompted research in developing alternative therapies, including the development of a wearable or implantable device.^[4]

The fiscal reality of lack of available resources to implement universal access to quotidian dialysis has in my opinion greatly influenced not only government policy on hemodialysis funding and modality in the United States (here), I believe it has also over shadowed and influenced research on quotidian dialysis as well. Anyone that attends the Annual Dialysis Conference expects the lively debates between nephrologists who passionately support more frequent and daily hemodialysis as opposed to those who equally voice opposition to quotidian dialysis.

The Frequent Hemodialysis Network study group findings on short daily hemodialysis and nocturnal dialysis dialysis demonstrates this paradox clearly. The short daily hemodialysis arm of the FHN study showed positive outcomes for daily dialysis but it appears that only the negative findings of the nocturnal arm matter to the nephrology community despite the excellent methodology of the FHN short arm vs. the deficiencies of the FHN nocturnal arm. (here and here) 

In March of this year, the nephrology community will gather once again at the Annual Dialysis Conference and debate the efficacy of more frequent hemodialysis vs conventional in-center treatment. An important part of those debates will involve the nocturnal FHN study:

Debate: More Frequent HD should be Recommended to Thrice Weekly HD Patients

• 8:00
  There Is Enough Evidence to Support this Recommendation - Madhukar Misra, MD
• 8:10
  The Frequent Nocturnal Hemodialysis Randomized Controlled Trial Does Not Support this Recommendation
  Alan Kliger, MD

Dr. Kliger will apparently sing a different tune speaking against more frequent HD than he did when he was appointed to the NxStage scientific advisory panel in 2011:

NxStage appoints Alan Kliger, MD to scientific advisory board

"The improved outcomes we saw in the FHN randomized controlled trial of daily dialysis should encourage patients and their physicians to consider daily hemodialysis as a serious option," said Kliger. "I''m excited to be involved with the team at NxStage, which is pioneering daily home dialysis with the System One in the U.S. and internationally."

More frequent hemodialysis is the hope of many patients today facing ESRD, but all too many nephrologists oppose the application of this simple therapy to their patients based largely on poor reimbursement from CMS. The despair of patients subjected to conventional in-center hemodialysis is evident with every single treatment where patients suffer from intradialytic hypotension followed by cramps, vomiting and passing out in centers that maximize profits at the expense of patient's outcomes. For over forty years we could have done better here in the United States and saved countless lives and further spared pain and suffering of patients yet we did not.

It is time for nephrologists to evaluate dialysis studies with a more rigourous eye towards poorly enacted methodology leading to questionable results. The FHN Nocturnal study is in my opinion a shameful publication that is fraught with such botched execution of its protocols that no one should uphold this as a reason to not engage more patients in daily dialysis. It is time to publicly admit the failure of the FHN nocturnal arm and declare this study null and void. Instead, just as nephrology dismissed the "insignificant" results of TIME in the NDCS (here) in 1981 leading to short dialysis duration and patient suffering and death, the FHN nocturnal study has the potential of setting daily dialysis to the back burner once again.

The NCDS dominated the optimal dialysis debate for decades until those that know and understand the power of more frequent and longer duration dialysis could produce the studies needed to bring the NCDS results into question. How many decades will the FHN nocturnal study dominate the debate on quotidian dialysis? Hopefully it won't given how flawed it is. However, the unjustifiable bias against daily dialysis continues today perhaps even more determined than it was before the short daily dialysis FHN study showed positive outcomes  for more frequent dialysis. Observing this highly respected researcher using the FHN nocturnal study as a basis for opposing more frequent dialysis sadly leads me to despair the number of people who will not have access to the benefits of daily dialysis because of this. 

The government support of research for new renal replacement therapy based on Dr. Kjellstrands "Unphysiology" theory is a source of hope but their hypocritical opposition to daily dialysis serves only to further despair. Dr. Kjellstrand was correct in 1975 and he remains correct today that more frequent and longer duration dialysis is the optimal dialysis strategy. Perhaps our only hope will be when these new technologies prove as cost effective as renal transplant. In that scenario, those that now vigorously oppose daily dialysis will likely become some of their most passionate supporters. We are left only with hope since it seems those that could make a difference today remain blind to our despair.

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 Dialysis Dilemma: What Would Scrib Do?

By Peter Laird, MD

Despite the demonstrable progress in recent years delivering the message of optimal dialysis, from time to time, a very negative portrayal of dialysis emerges in the popular press that paints a shaded picture of the true miracle of hemodialysis that today sustains two to three million people around the world.

I was quite disappointed to read  a recent article that ended on just such a sour note of despair with dialysis despite celebrating the stories of both Bill Peckham and Nancy Spaeth who have graced the world with lives well lived despite ESRD. After all, both Bill and Nancy are still working and contributing greatly to their families, friends and community. It appears that the author of this article failed to capture the true miracle of saved lives with hemodialysis with their example she noted, but does not appear to truly understand.

The dialysis dilemma: urgent need vs. overtaxed system

A HALF CENTURY ago, nobody predicted so many people would have end-stage kidney disease. Or that treating it, per patient, would be one of government's most expensive entitlements.

Now, nephrologist Kelly says, the problem isn't picking which patients should get dialysis; it's that doctors, patients and families seem unable to pick which patients shouldn't.

A few months ago, at a NKC celebration, he called for reconstituting "The Committee" — albeit with a 180-degree change in its mission. It was a moment to pause.

Kelly fervently believes that health care is a right. But he also thinks dialysis has gone too far.

Unfortunately, the story of dialysis today is not that it has gone too far, but that it has not gone far enough. Hemodialysis machines operate in much the same fashion as they did when the doors to renal replacement therapy swung open with the ESRD program in 1973. Since that time, despite the technological revolution that we have seen throughout modern medicine with improved survival from technological advance, the basic components of hemodialysis remain remarkably the same. Although even here there are indeed improvements in buffers, hollow fiber tubing, software, and other aspects of delivering the provision of dialysis, one aspect that has not seen any improvement in hemodialysis is improved outcomes.

The for-profit dominated dialysis industry has focussed their efforts on improving the bottom line of corporate profits but as an industry they have not advanced the technology to improve outcomes in any sensible fashion. In this regard, dialysis has not gone too far at all. Nevertheless, Dr. Kelly is speaking of the ethical dilemmas of open access to this expensive care and not the need for further technological advances.

The dialysis dilemma: urgent need vs. overtaxed system

 Today, with the door to dialysis swung wide open, Kelly argues, doctors, families and patients need a committee because someone, somehow, has to say no.

He battles with himself out loud. "I think, 'Am I some kinda Hitlerian guy, that I want to stop all these treatments?' "

Then he recalls "Scrib," Scribner himself, fearlessly insisting that uncomfortable, tough issues be aired. "I frequently say, when I'm dealing with a case, 'What would Scrib do?' " Kelly says.

"I'm trying to do the right thing — what I think is the right thing."

The study of medical ethics can be summed up simply enough as doing the right thing in difficult circumstances. I am pleased that Dr. Kelly seeks the wisdom and knowledge that "Scrib" would advise America in these trying times. However, seeking to return to "God committees" more properly called death panels from his description is not the avenue that I believe Scrib would venture with the so called "dialysis dilemma" we face today.  Dr. Christopher Blagg wrote a touching and informative tribute to his lifelong friend and colleague shortly after Dr. Scibner's untimely death in 2003. One short paragraph in this tribute speaks loudly on where I believe Scrib would want us to go:

Belding Hibbbard Scribner - Better Known as Scrib

Scrib always said he had been lucky all his life, but he was successful because of his perseverance in problem solving and his delight in tinkering with devices. He was a great teacher and leader and a generous person. His first concern was always for patients, and his other major concerns included for-profit dialysis, the future of U.S. medicine, and the future of the world.

I believe Dr. Blagg characterized best "what would Scrib do?" by noting his devotion to patients first and foremost coupled with his ability for problem solving. The great tragedy of dialysis is not that we have too many patients in need of this life saving technology,  but instead that we have spent too little time problem solving and tinkering with  any new technology. Modern technology seems to have side-stepped the dialysis industry as it ground the constant drumbeat of profiteering above and beyond the love of the patients they serve truly giving a new definition to blood money.

What would Scrib do? I believe he would tinker and problem solve with newer and improved technology and freely give that technology to medicine for no profit of his own as he did with the Scribner Shunt. Instead of profiting millions of dollars personally by his new invention, Dr. Scribner freely gave this life saving device to the entire medical community which is an ethic sadly missing today.

I don't believe that Nancy Spaeth and Bill Peckham wish to be known for an article essentially calling for death panels in the current world of re-engineering dialysis. Instead, they are filled with courage and devotion to this modern medical miracle made possible by a humble man. Where is our present day teacher and leader who shall advance the provision of dialysis in the same spirit of saving lives as both Bill and Nancy testify daily? Both knew and loved Dr. Scribner who served not only as a mentor, encourager and teacher, but as their lifelong friend. Dr. Scribner did not heed the modern admonition of doctors not getting attached to their patients, he instead embraced them with all of his heart and mind and soul.

How many nephrologists today have patients that will outlive them? Even Dr. Scribner's very first patient, Clyde Shields,  lived for over eleven years before cardiovascular disease claimed his rejuvinated life. The amazing panel of Dr. Scribner's patients have lived lives testifying of this truly remarkable invention. (here, and here)

I believe he would approach all patients with severe renal impairment with a courageous strength to save lives above all other concerns. Has dialysis gone too far? No, not at all. It has instead failed to advance far enough that the provision of dialysis is still far too excessively expensive and strangled by an industry that cares first and foremost about reaping ever enlarging corporate profits. What would Scrib do? I believe Dr. Blagg told us quite clearly in his loving tribute that he would focus on the patient tinkering with new technology and giving it all freely away to save lives. Yes, that is what Scribner would not only do, but that is what he did.