HemoDoc, From Doctor to Patient

World Kidney Day - March 8, 2012

By Peter Laird, MD

March 8 is World Kidney Day organized by ISN and IFKF to promote knowledge of kidney disease around the world. World Kidney Day began in 2006 and continues to gain strength offering awareness of prevention and treatment alternatives. Unfortunately, since the first World Kidney Day, millions of people around the world have been affected through the ravages of HTN, diabetes and other renal diseases. One aspect of World Kidney Day is publicizing how prevalent this problem is around the world. Sadly, the numbers of people affected by these conditions continues to grow rapidly.

The growing prevalence of diabetes worldwide

There are currently over 240 million people with diabetes worldwide. This figure is projected to rise to 380 million by 2025, largely due to population growth, aging, urbanization, unhealthy eating habits, increased body fat and a sedentary lifestyle. By 2025, the number of people with diabetes is expected to more than double in South-East Asia, the Eastern Mediterranean and Middle East, and Africa.

It is projected to rise by nearly 20% in Europe, 50% in North America, 85% in South and Central America and 75% in the Western Pacific region. The top five countries with the highest prevalence of diabetes in order include India, China, the United States, Russia and Japan. Worldwide more than 50% of people with diabetes are unaware of their condition and are not treated.*About 40% of people with diabetes will develop CKD which increases the risk of cardiovascular and other complications of diabetes.

Growing prevalence of high blood pressure in populations worldwide

High blood pressure is a major global health problem and is projected to get worse. It is the major cause of CKD worldwide. The world population is getting older, and aging is the most common risk factor for the development of high blood pressure and diabetes as well as CKD. Nearly one billion people worldwide have high blood pressure and that number is expected to increase to 1.56 billion by 2025. The prevalence of high blood pressure is predicted to increase by 24 percent in developed countries and by 80 percent in developing regions such as Africa and Latin America. A recent report noted that 333 million adults in economically developed regions such as North America and Europe had high blood pressure in 2000, with an additional 639 million people in developing countries with this condition*.

Perhaps on this day, we can all pause and take account of the good health we enjoy even if already on dialysis. Many around the world with the same conditions we have do not have access to any renal replacement treatment options. Truly, these are global issues that extend beyond borders. On this day, each of us needs to do our part to bring about relief of all the pain and suffering these diseases bring upon our fellow man. Each of us has a part to play, if only we will.

The Lufkin DaVita Murder Trial Begins: Will the Prosecution have a Smoking Gun or Clouds of Confusion?

By Peter Laird, MD

The long awaited and highly publicized murder trial alleging that Kimberly Saenz infused bleach into ten separate patients, five of whom allegedly died at her hand. On the eve of this momentous trial, the weight and preponderance of the evidence is at question that will be presented during the next three weeks the trial is expected to take. During this time, complex medical issues will be at the forefront of the prosecutions case.

The defense has stated publicly for months that they believe that Kimberly is a scapegoat for alleged improper procedures at this dialysis unit. I am personally eager to see the full presentation by both the prosecution and the defense in this trial that promises to be technically difficult even for health care professionals. The history of murder cases involving highly technical expert witnesses and evidence often is one where the jury sides with the defense as we have seen with the O.J. Simpson case and the recent child murder case in Florida with Casey Anthony's acquittal last year. Perhaps the most complex medical case to date is that of Claus von Bulow who was originally convicted in his first trial and then acquitted on his second trial.  Questions still linger on all of these cases.

 

The prosecution faces a monumental hurdle in that bleach is undetectable in the human body and only surrogate markers of bleach infusion can be used. On top of that, there are only a handful of bleach infusion cases known in the entire body of medical literature making it a case where expert witnesses in bleach infusion cases are few and far between for both the prosecution and the defense. Making it even more difficult is the fact that of those few cases known, more than one had no acute or chronic injury from the known infusions of small volumes of bleach:

Intravenous injection of household bleach

Abstract: The widespread use of household bleach (5.25% sodium hypochlorite) as a disinfectant by IV drug users may cause an increase in the number of IV injections of this substance. We report the case of a 31-year-old man who injected less than 1 mL of bleach and then experienced transient left-sided chest pain and vomiting. The patient did not have any serious complications. This report is similar to the only other reported case in the medical literature of an IV injection of a small amount of bleach. Based on these two reports, household bleach appears to be safe when used as a disinfectant by IV drug users, but more studies are needed.

The number of patients involved in this case will make for volumes of evidence by virtue of the average complexity of dialysis patients,  most of whom have multiple comorbid diseases.  Even if the prosecution can produce evidence of chlorinating agents, will they be able to put that solely in the hands of the defendant in the end analysis, or will the defense produce conflicting evidence giving rise to reasonable doubt? Sifting through all of the evidence certainly to be presented, that will be the final question beyond a reasonable doubt. Many watching the Casey Anthony case were shocked at the verdicts rendering a complete vindication for all charges. Complex medical cases may become too complex for the jury to comprehend which may be a detriment to the prosecutions case. If the prosecution fails to produce a "smoking gun" in this case, then the mountains of evidence and complex scientific studies even involving rats and 3-chlorotyrosine may instead become clouds of confusion even for the most astute jurors.

The Lufkin Davita Bleach Murder Case: What is 3-chlorotyrosine?

By Peter Laird, MD

The long awaited Lufkin DaVita bleach murder case is on the verge of commencing with the early salvos by the prosecution and the defense coming to light in a recent hearing on the admissibility of evidence. (here) An immediate question that arises out of an early report is what is 3-chlorotyrosine and why is it an important part of the prosecution evidence?

State, defense in Saenz case argue over validity of evidence

“The court needs to understand that at no time did the state or prosecution find bleach in blood, but instead found 3-chlorotyrosine,” Deaton said.

In addressing Deaton’s issues with the research’s validity, Angelina County District Attorney Clyde Herrington chronicled the death of one of Saenz’s alleged victims, a man the prosecutor said entered the dialysis center in good shape but did not leave that way.

“He was carried by his wife that morning (to the center). He was in good spirits. He laughed, he joked, he ate a boiled egg. He’s doing fine and the next thing you know, he’s unconscious,” Herrington said. “He died three to four months later.”

“Massive levels” of 3-chlorotyrosine were present in the man’s body, Herrington said. Defense team member Thomas W. Deaton attributed the patient’s  3-chlorotyrosine level to a “massive infection.”

There is no pathogneumonic test for bleach infusion. (A sign or symptom that is so characteristic of a disease that it makes the diagnosis).  The prosecution and the defense have already started to square off over the issue of 3-chlorotyrosine allegedly found in some of the alleged victims of Kimberly Saenz. 3-cholortyrosine is not an ordinary blood test performed in a doctors office or in a dialysis clinic. It is a very obscure research tool for elucidating exposure to chlorinating agents. There are only a handful of clinical studies measuring both the natural levels of 3-chlorotyrosine as a marker of inflammation and infections for instance. 

Myeloperoxidase: friend and foe

Neutrophilic polymorphonuclear leukocytes (neutrophils) are highly specialized for their primary function, the phagocytosis and destruction of microorganisms. When coated with opsonins (generally complement and/or antibody), microorganisms bind to specific receptors on the surface of the phagocyte and invagination of the cell membrane occurs with the incorporation of the microorganism into an intracellular phagosome. There follows a burst of oxygen consumption, and much, if not all, of the extra oxygen consumed is converted to highly reactive oxygen species. In addition, the cytoplasmic granules discharge their contents into the phagosome, and death of the ingested microorganism soon follows. Among the antimicrobial systems formed in the phagosome is one consisting of myeloperoxidase (MPO), released into the phagosome during the degranulation process, hydrogen peroxide (H₂O₂), formed by the respiratory burst and a halide, particularly chloride. The initial product of the MPO-H₂O₂-chloride system is hypochlorous acid, and subsequent formation of chlorine, chloramines, hydroxyl radicals, singlet oxygen, and ozone has been proposed. These same toxic agents can be released to the outside of the cell, where they may attack normal tissue and thus contribute to the pathogenesis of disease. This review will consider the potential sources of H₂O₂ for the MPO-H₂O₂-halide system; the toxic products of the MPO system; the evidence for MPO involvement in the microbicidal activity of neutrophils; the involvement of MPO-independent antimicrobial systems; and the role of the MPO system in tissue injury. It is concluded that the MPO system plays an important role in the microbicidal activity of phagocytes.

There is only one study I am aware of at this point looking at naturally occuring 3-chlorotyrosine levels in dialysis patients by Dr. Himmlefarb. 

Myeloperoxidase-catalyzed 3-chlorotyrosine formation in dialysis patients

Oxidative stress has been implicated in the cardiovascular complications that affect chronic renal failure patients on hemodialysis, though the physiologically relevant pathways mediating oxidative damage are poorly understood. It is known, however, that hemodialysis activates neutrophils, a well-characterized source of hydrogen peroxide and myeloperoxidase. The phagocyte-derived myeloperoxidase-hydrogen peroxide-chloride system generates hypochlorous acid, which reacts with tyrosine residues of proteins to form 3-chlorotyrosine. To explore the role of activated phagocytes in oxidative stress in chronic renal failure, we used 3-chlorotyrosine as a specific marker of myeloperoxidase activity. Utilizing isotope dilution gas chromatography-mass spectrometry, we compared 3-chlorotyrosine levels in plasma proteins of five patients on chronic hemodialysis therapy with those of age- and sex-matched healthy controls. The oxidized amino acid was present in the plasma proteins of 4 of the hemodialysis patients (3.5 +/- 0.8 micromol per mol tyrosine) but was undetectable in the healthy subjects. Therefore, one pathway for oxidative stress in hemodialysis patients appears to involve hypochlorous acid generated by the myeloperoxidase system of activated phagocytes. We also examined intradialytic 3-chlorotyrosine levels using membranes that activate white blood cells and the alternative pathway of complement. Hemodialysis increased plasma myeloperoxidase and the expression of CD11b/CD18 by circulating phagocytes, but failed to demonstrably increase 3-chlorotyrosine levels. 3-chlorotyrosine was detectable in 12 of 19 samples in total, with significant intrasubject variability. Our observations suggest that oxidants generated by myeloperoxidase contribute to the increased oxidative stress observed in renal-failure patients but do not damage plasma proteins during the hemodialysis procedure itself.

This complex little known clinical entity is suddenly thrust on the stage of a prominent murder case where it may promise more confusion than clarity. One of the questions immediately present is how well will the jurors correlate studies on chlorine gas in rats causing 3-chlorotyrosine levels compared to complex dialysis patients with multiple co-morbid conditions where naturally occurring 3-chlorotyrosine levels are already documented and applying that as evidence to proof of murder. This is only the beginning of a very long, complex case.

The Lufkin Davita Bleach Murder Case: Opening Salvos

By Peter Laird, MD

Kimberly Saenz is under indictment for the alleged murder of five dialysis patients and five other patients allegedly harmed by bleach infusion. In an interesting opening evidence hearing on the admissibility of a study on rats exposed to chlorine gas, the defense argued against hearing this evidence as it has never been duplicated in humans. In this opening salvo of evidence by the prosecution and counter moves by the defense, the one issue clear in this case is that it will be a difficult and complex medical and science laden, circumstantial evidence case. 

State, defense in Saenz case argue over validity of evidence

“The court needs to understand that at no time did the state or prosecution find bleach in blood, but instead found 3-chlorotyrosine,” Deaton said.

In addressing Deaton’s issues with the research’s validity, Angelina County District Attorney Clyde Herrington chronicled the death of one of Saenz’s alleged victims, a man the prosecutor said entered the dialysis center in good shape but did not leave that way.

“He was carried by his wife that morning (to the center). He was in good spirits. He laughed, he joked, he ate a boiled egg. He’s doing fine and the next thing you know, he’s unconscious,” Herrington said. “He died three to four months later.”

“Massive levels” of 3-chlorotyrosine were present in the man’s body, Herrington said. Defense team member Thomas W. Deaton attributed the patient’s  3-chlorotyrosine level to a “massive infection.”

“If ever there were a poster boy for a massive infection, it would have been (this patient). He came in with one prosthesis and lost another leg in the hospital,” Deaton Sr. said. “To give the jury that testimony to show a cause ... It’s bad science.”

The simple fact remains that there is no single, definitive and pathogneumonic test (A sign or symptom that is so characteristic of a disease that it makes the diagnosis) for bleach infusion. Of all the poisons and toxic chemicals, it is quite unique in that the body manufactures chemicals quite similar to bleach used mainly in immune cell reactions. Bleach is broken down by naturally occurring enzymes in the body. When we think of poisoning cases, most of the time it is a simple matter to run very precise tests showing evidence of a specific chemical. Not so in this case. Evidence of bleach infusion and its effects on the body is not directly measurable. In such, this entire case will depend on secondary tests that the prosecution will claim are evidence of bleach infusion. 

The defense has publicly stated from the beginning that they believe Kimberly Saenz is a scapegoat for DaVita and the alleged clinical mistakes by DaVita.

State, defense in Saenz case argue over validity of evidence

From the beginning, Deaton has maintained that Saenz is merely a scapegoat for the company’s oversights and clinical mistakes. On March 5, a dozen jurors and two alternates will walk into Bryan’s courtroom to decide whether she is to blame.

For those expecting a quick and straight forward case, the fact that surrogate markers of bleach are the only evidence of bleach infusion places this case at its onset as one that is going to be complex, filled with high tech science most likely never used before in a murder case and complex patient medical records on top of allegations by the defense of clinical failures by DaVita. In the end, DaVita may be on trial as much as Kimberly Saenz. We will have to wait for the full case to develop in the news reports, but it will likely not be a straight forward case and assigning guilt or innocence is going to be a very difficult position for the jury to consider.  

Consider that the prosecution is using chlorine gas exposure on rats without any human counterpart testing as evidence of murder. Many reading the Lufkin article above have probably already asked, what is 3-chlorotyrosine and what do rats have to do with a murder case? The answers to these questions and how complex the science is behind this case are daunting for trained medical specialists none of whom are likely to find their way on this jury of her peers. This will likely prove to be on of the most complex, circumstantial murder cases known to date.

Coach Tom Martinez: Never Quit

By Peter Laird, MD

Tom Martinez is a man that has spent his life motivating and teaching thousands of college and high school athletes throughout his long career. During this time, he has not only secured his place as one of the most successful college level coaches, but his dedication to never quiting and always pushing forward is an inspiration not only to those involved in sports, most notably, his prodigy, Tom Brady of the New England Patriots, but for all that face life threatening diseases. Sadly, Tom lost his battle, but his words of encouragement remind all struggling against the ravages of diabetes, heart disease and chronic kidney disease that at times, it is the simply the will to live that endures:

 

Sadly, the testimony of his wife is one repeated over and over in America where she stated matter of factly that dialysis was killing him:

Tom Brady's QB guru, Tom Martinez, dies from heart attack on 66th birthday

Martinez suffered through continuous kidney issues and complications from Type 2 diabetes as he continued to be consumed by football and coach protégés ranging from Brady to current college prospects. His health declined precipitously over the summer as he sought a kidney transplant, but the dialysis — a process that alternately weakened and sustained him — left him drained in recent days. 

“We were convinced the dialysis was slowly killing him,” said his wife of 46 years. “UCLA (Medical Center) just couldn’t be bothered to take someone at such high risk.”

My condolences go out to his family and his friends, but I would hope that the message of dialysis is not tainted as a life taking procedure from this sad account. When done properly, it can and does sustain and restore life for thousands of patients. Unfortunately, with the stated heart, diabetes and kidney problems, Tom Martinez was at the highest risk of cardiovascular death at the onset of his dialysis treatment. The media is not discussing his dialysis modality, but it goes without saying that the majority of dialysis patients in America who could benefit from  the longer and slower nocturnal treatments pioneered in Canada for exactly this type of patient most likely was not presented to him if he fell within the usual informed consent where as little as 12% of patients hear of optimal dialysis modalities.

The world has lost a wonderful coach, father and husband when Tom Martinez succumbed to his long battle against diabetic complications with his heart attack. There are many battles worth fighting, not the least of which is the battle to overcome the American dialysis hegemony in opposing optimal dialysis practices in favor of for-profit, greed motivated short, violent and debilitating dialysis sessions most patients experience daily. I truly understand why many "hate dialysis." Sadly, Tom Martinez widow may have sagely spoken well that the dialysis was slowly killing him. What a sad testimony for such a nobel experiment suborned by profiteering  and greed.

This is just one more case, one more reminder that we need to never quit until dialysis modalities do as they were envisioned by Dr. Scribner when his serendipitous invention of the Scribner shunt brought the promise of his predecessors to life. Tom Martinez appears by his widow's report to possibly be one of many thousands of patients ill served by dialysis. Never quiting as Tom Martinez encouraged in life, let his death inspire those in the dialysis industry to just "win one for the gipper" and bring to an end the type of dialysis in America that leads widows to speak bitterly of this therapy. Instead, let it be that people on dialysis had never quit and were grateful for all. We can only dream.

Dialyzing at Home Alone: Is There Not a Cause?

By Peter Laird, MD

Dialysis in America is different than the other developed nations. The focus in America is very much industry centric instead of patient centric. One of the most profound examples of the differences between dialysis in the United States and other developed nations is the nearly universal prohibition against patients dialyzing at home alone. Canada, England and Australia not only allow patients to dialyze at home alone, the entire focus in those nations is on self care as a responsibility of the patient and not the care takers.  There are many barriers to dialyzing at home alone including companies such as NxStage which included the provision of a care partner in their FDA approval as well as dialysis providers. Some States also prohibit dialyzing at home alone.

Physicians bear the brunt of the responsibility in ensuring safe dialysis practice. From my own experience, the overwhelming impression among my colleagues in internal medicine is that dialysis is a dangerous procedure. Certainly, it is an invasive procedure but I believe the instinctive reaction of most physicians including nephrologists comes from the iatrogenic complications seen daily in dialysis units where patients routinely collapse from rapid volume depletion due to excessive ultrafiltration rates. The stable dialysis patient is a foreign consideration in most dialysis units. The reaction of most providers when discussing dialyzing home alone is as astonishing as Macaulay Culkin's iconic realization he was home alone.

When I first started dialysis, I was surprised that I survived each treatment when I considered my own professional bias against dialysis learned in the intensive care units where more than one dialysis patient "crashed." As I learned more about optimal dialysis and applied that knowledge to my own treatments, I slowly realized that the philosophical approach and application of treatment is the most important stabilizing factor. In five years of dialysis, I have never once vomited, passed out or even become lightheaded except for the one time that my dialysis technician set my ultrafiltration for 5000 ml instead of 500 ml. After 2.3 liters, I began to be nauseous and lightheaded. Two liters of normal saline reversed that medical error.

Bill Peckham recently celebrated ten years of home hemodialysis, nine of which have been self dialyzing home alone. The benefits of home dialysis far outweigh any associated risks especially when compared to the risks of standard care. In the time Bill has been dialyzing self sufficiently, he has accomplished more than many people accomplish with intact kidneys. This is a picture of Bill dialyzing on board his boat that he captained north of Seattle.  For the average nephrologist practicing in America, Bill would be a nightmare of medical legal risk in their skewed views of the usual dialysis patient. Living a life well is a goal all of us have.  Adding the burden of renal disease makes this endeavor a daily struggle, but the example that Bill has set for the entire renal community should not go unnoticed. I must confess that the idea of strapping a generator and a dialysis machine to an inflatable white water raft going down the Rogue River is not my idea of a self care dialysis unit. But the truth is that this is not only possible, but it is safe. In fact, dialyzing on terra firma with a generator in many ways is much safer than floating down a wild river on a piece of rubberized plastic. (here)

 

With the resurgence of home hemodialysis after decades of suboptimal dialysis care languishing in for-profit dialysis units, the plight of those who are capable of self care yet are hindered by arbitrary standards requiring a care partner is a cause worth fighting. It is time to evaluate the stable dialysis patient and note that life itself is not risk free, but it is worth living well. For patients on dialysis, living well in many ways means taking charge of your own care at home. As the market place opens the door to thousands of new home hemodialysis patients, the American dialysis industry needs to grow with their patients as they overcome their own fears and anxiety inherent in doing self care. The last issue a patient needs in this circumstance is physicians and providers more concerned about their own anxiety over dialysis. The reality is that dialysis can be safe and stable even when dialyzing home alone not only in Canada, England or Australia, but right here in the United States as well.

The FDA ESRD Challenge: Is This an Omen of Good Things to Come?

By Peter Laird, MD

Innovation in health care devices must pass the scrutiny of the FDA process which is by many accounts arduous and overly expensive. Today, the FDA announced the formation of an ESRD Innovation challenge where medical devices for use in the ESRD population will be undergo and expedited review in the hopes of bringing these devices to the market quickly.

• Developing a New Approach to Device Review
• Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

The question that proceeds from this announcement is why would the FDA introduce such a program if it was not needed by virtue of innovations already in development for years by several companies here in the US and abroad that are now ready for introduction? At this point, there are no public announcements by those who have previously secured venture capital for the development of several new and innovative hemodialysis devices, but perhaps the FDA ESRD challenge is the harbinger foreshadowing the long awaited hemodialysis device entries by several companies known to have active research and development investments. We can only hope but in the least, this is a very intriguing development.

Nephrology News and Issues Sponsors DOPPS DPM Update

Nephrology News and Issues will moderate a webinar hosted by the Dialysis Outcomes and Practice Patterns Study (DOPPS) updating the latest findings in the DOPPS Practice Monitor (DPM) report. If you would like to participate in this webinar, you may register at the following location:

DPM Web Conference

The DOPPS will host a web conference regarding this latest DPM update moderated by Nephrology News and Issues onThursday, January 19 at 3 p.m. EST. 
DOPPS Practice Monitor investigators will be available to answer your questions about emerging trends in hemodialysis care. 

To participate, please click here to register.

   

Questions must be submitted in advance. Please submit questions by Thursday, January 12 by sending an e-mail to[email protected] with "DPM questions" in the subject line. 

I wish to thank Bill Peckham of DSEN for advising me of this upcoming webinar reviewing important practice changes since the implementation of the Renal Bundle. 

 

Jack Black Reigns at the Renal Teen Prom 2012

by Peter Laird, MD

Lori Hartwell of the Renal Support Network continues her close relationship with Jack Black and the Renal Teen Prom one more time. Jack Black thrilled all in attendance with his outlandish antics dressed this time as a king. Most notably, Jack Black is reported to have skipped the Golden Globe awards ceremony to attend this charity event.

Jack Black Skips Golden Globes to attend special prom

"It's a prom for kids that have kidney disease, that have had a transplant and didn't get to have a prom of their own, cause they were having medical problems," Black said. "And it's a great night where kids get to meet other kids that have had the same situation, make friends and share their stories... and have a really good time. Lot of good times... dancin'... singin'... partyin'... you know prom."

Lori Hartwell continues to promote optimal renal care and goes beyond to give back to the children deprived of many basic social outlets due to their disease. For more information on the Renal Support Network teen prom is available on the RSN website. (here)

A Mad Tea Party

By Peter Laird, MD

For an American dialysis patient, the transition from the old prospective payment system where dialysis units made huge profits from separately billable items such as ESA and Vitamin D analogs, to the new bundled payment system is tantamount to the confusion and irrational logic of Alice in Wonderland at the mad tea party. In the first few months of the new CMS bundle, ESA use is dropping dramatically according to initial reports and Hemoglobin levels are likewise plummeting. Then CMS shocked the renal world by issuing the final rule for the QIP that does not include any minimum Hb standard leaving clinicians guessing as how to proceed.  The LDO's have no question on how they are proceeding, for the average dialysis patient not on the transplant list, frequent blood transfusions and chronically low Hb levels will be the new norm. 

Uncontrolled secondary hypertension is now raging in the black hemodialysis population which historically requires higher levels of Vitamin D analogs to control PTH levels. 

Uncontrolled SHPT On the Rise in Blacks Since Debut of 'Bundling'

Using data from the DOPPS Practice Monitor, which follows a nationally representative sample of about 140 U.S. dialysis centers serving 20 or more chronic HD patients, researchers examined trends in parathyroid hormone (PTH) values and SHPT therapies from July 2010 to February 2011.

The median PTH value increased from 296 to 379 pg/mL among blacks and from 244 to 283 pg/mL among non-black. The prevalence of severe uncontrolled SHPT (defined as a PTH level above 600 pg/mL) increased sharply from 16% on July 2010 to 26% on February 2011, but only slightly from 9% to 11% among non-blacks.

The business of dialysis always comes before the outcomes of dialysis here in America and the new CMS renal bundle will be championed by the academic nephrology community touting its ability to save money. 

Implications of a Reduction in the Hemoglobin Target in Erythropoiesis-Stimulating Agent-Treated Hemodialysis Patients

The data demonstrate that by reducing Hb levels to 9–11 g/dl, we decreased the chance of having Hb levels rise to values >12 g/dl (fig. 1). At the same time, there was a decrease in ESA usage: from January to December 2009, the average EPO dose per week decreased from 9,500 to 5,600 units. This result yielded an approximately 40% reduction in ESA usage per dose per week. In 2009, we saved more than USD 60,000 for the approximately 35 patients we cared for.

Shabbily completed research studies with no distinct conclusions are now the basis for questioning the efficacy of extended and more frequent hemodialysis sessions with the FHN nocturnal study leading the pack. Since when does an underpowered, over selected, inconclusive study demonstrate actionable logic to call for an end to nocturnal home hemodialysis? 

Dialysis: Nocturnal hemodialysis - should we still provide this therapy?

Frequent nocturnal hemodialysis has emerged as a promising option for patients, with some studies demonstrating that it improves clinical outcomes. However, the negative results of a recent randomized trial have cast some doubt on whether nocturnal home hemodialysis has any advantages over conventional hemodialysis.

America struggles to stop dialyzing patients with rapid, short and violent sessions guaranteed by the simple physiology of third space fluid mechanics to cause intradialytic hypotension when they could avoid the entire problem in the majority of dialysis patients by simply slowing down blood flow rates and ultrafiltration rates with longer dialysis sessions. The "rocket science" of avoiding intradialytic hypotension in America is predicated on the false premise that we have to continue to place the business of dialysis before the outcomes of dialysis. In addition, both anemia and mineral bone disease parameters improve with NHHD lowering the requirements for ESA and Vitamin D analogs. Yet, the logical answer to all of these questions is dismissed by the LDO's and CMS.

The mad hatter we call CMS continues to demand a randomized and controlled trial demonstrating superior morbidity and mortality from quotidian dialysis before approving payment for this well documented life saving modality. Ultimately, we are left with a vacuous conversation based on an illogical and irrational discourse. No wonder dialysis patients are as perplexed as Alice at the mad tea party.

A Mad Tea Party

Alice felt dreadfully puzzled. The Hatter's remark seemed to have no sort of meaning in it, and yet it was certainly English. `I don't quite understand you,' she said, as politely as she could.

`The Dormouse is asleep again,' said the Hatter, and he poured a little hot tea upon its nose.

The Dormouse shook its head impatiently, and said, without opening its eyes, `Of course, of course; just what I was going to remark myself.'

`Have you guessed the riddle yet?' the Hatter said, turning to Alice again.

`No, I give it up,' Alice replied: `what's the answer?'

`I haven't the slightest idea,' said the Hatter.