Dialysis from the sharp end of the needle

Offering an EOD schedule is the best response to patients skipping treatments

By Bill Peckham

At the risk of becoming The Bruce Dikinson of the dialysis industry, when I read the JASN abstract that connects skipping dialysis with URRs below 65%, and thus a 1% payment withhold under the QIP, I think the only prescription is more cowbell! dialysis! Offering Every Other Day (EOD) schedules is the best response to control the cost of skipping.

The JASN paper only addresses the costs associated with being subject to a 1% withhold under the QIP, this understates the cost to the unit of skipping.

Think of a person who comes every treatment, who dialyzes 156 times a year, who we'll call G ... compared to someone who tends to skip twice a month and at the end of the year has dialyzed 130 times, who we'll call D.

First, one reason a person may skip regularly is that they don't feel very well when they do dialyze three times a week; if you're going to feel unwell if you do or you do not go to dialysis, you'll be more likely to not go. EOD schedules, when followed, would increase the person's chance to feel well, thus their ability and willingness to accommodate regular dialysis. But we're talking money, skipping and costs.

On the cost front, consider G's financial impact. Each dialysis payment under the expanded bundle is made up of fractional payments. Lab tests are in the bundle; each one of G's 156 reimbursements include some amount intended to cover lab tests. If G dialyzes 13 times in the month it means that the unit received 13 fractional payments intended to cover the cost of labs.

In addition with each payment the center received fractional payments to cover other monthly services and fractional payments for services that are delivered quarterly or yearly. All sorts of services required by the Conditions for Coverage are paid for a little at a time out of each individual, treatment, reimbursement e.g. the cost of care planning, iron, social worker support, PTH tests, Hepatitis tests, nutritionist support are all paid for a little at a time, by each treatment even though they don't necessarily happen each treatment.

Now consider D's financial impact. Labs still need to be done each month but at the end of the month there are only 11 fractional payments available to pay the cost of running the tests. D, just through skipping, generates 16% less revenue to pay for services delivered at frequencies less than each treatment.

The biggest financial effect may be D's EPO profile before and after skipping. In general let's assume D will need the same yearly dose of EPO whether dialyzing 156 times a year or 130, D will need 624,000 units of EPO (likely D would need a higher yearly dose due to skipping). If D runs 156 times the EPO dose will be 4,000 units per treatment. If D runs 130 times the EPO dose will need to be 4,800 units per treatment. D's skipping makes each treatment less lucrative, over and above any QIP withhold.

EOD schedules fix the financial side of this problem. Skipping in and of itself is a clinical problem, and as the JASN authors note there are as many reasons for skipping as the mind can imagine. But skipping shouldn't mean not having access to dialysis and units shouldn't be trapped into a needless financial drain. I don't think D is thinking: I only need to dialyze 11 times this month, more likely, about twice a month, D has a sense that: I need a break.

With an EOD schedule D would receive the 13/month medical minimum number of treatments - enough dialysis to avoid expensive hospitalizations and keep URRs above 65%; the unit would have received the number of payments anticipated by the bundle to pay for formerly separately billable services; and D would have had two breaks during the monthly grind. Win. Win. Win.

D should be given an EOD schedule and expected to call the unit as soon as the intention to skip is known.

Every Other Day (EOD) incenter dialysis schedules can be done (Part I); EOD schedules would improve clinical outcomes and support patient choice (Part II); EOD schedules are implicitly supported by MAC/FIs (Part III); EOD schedules would improve the clinic's finances and may lower overall Medicare costs per person, per year (Part IV); EOD schedules would increase the clinic's value (Part V). And, EOD schedules are a sensible clinical and financial response to patients who routinely skip treatments.

Deeply confused New York Times article is a disservice to dialyzors

By Bill Peckham 

RenalWeb links to a front page New York Times article When Ailments Pile Up, Asking Patients to Rethink Free Dialysis by Gina Kolata. This is the article's leed:

Of all the terrible chronic diseases, only one — end-stage kidney disease — gets special treatment by the federal government. A law passed by Congress 39 years ago provides nearly free care to almost all patients whose kidneys have failed, regardless of their age or ability to pay.

Access to Medicare does not equate to "nearly free care" and not everyone has earned Medicare access.

Right now Medicare leaves about $50 per treatment unpaid and the responsibility of the beneficiary (Medicare routinely pays 80% of approved charges). Given 156 treatments a year this amounts to about $7,800/year unpaid, just for the dialysis ... in addition the beneficiary incurs 20% of the cost of doctors, nondialysis medications and any other medical care required outside the dialysis unit.

Also, not all individuals with ESRD are eligible for Medicare, about 10 to 15% will never have access because in addition to a diagnosis of ESRD, one of the following criteria must be met (PDF link):

1. The individual must meet the required work credits under Social Security, Railroad Retirement or as a government employee 
2. The individual is receiving Social Security or Railroad Retirement benefits 
3. The individual is the spouse or dependent child of a person who has met the required work credits or is receiving Social Security or Railroad Retirement benefits. 

Currently the required work credits under Social Security is 40 quarters - 10 years of paying into the program - there is a detailed explanation here. 

But the article's error laden leed is not even its worse offense. It continues:

But the law has had unintended consequences, kidney experts say. It was meant to keep young and middle-aged people alive and productive. Instead, many of the patients who take advantage of the law are old and have other medical problems, often suffering through dialysis as a replacement for their failed kidneys but not living long because the other chronic diseases kill them.

No no no. Dialyzors who are "old and have other medical problems" have access to Medicare due to age or disability, "patients who take advantage of the law" are few: only about 25,000 people have access to Medicare as a consequence of Section 299I of the Social Security Amendments of 1972.

The article does shine a light on an important discussion about end of life care and informed consent. That's an important subject, however, it is only tangentially related to the ESRD Entitlement. The point of the article is that caring for the elderly is expensive and aggressive treatment may not always be in the interest of the ill. That is a serious discussion our electorate should have but has not been able to have; this article makes that discussion even more difficult. 

Are American Dialysis Patients the new Tuskegee Syphilis Group?

By Peter Laird, MD

In 1932, the US Public Health Service in Tuskegee, Alabama commenced the ill fated Tuskegee Syphilis Trial on the natural progression of the disease when they recruited 399 African-American sharecroppers already infected with syphilis.  None of the participants were ever told what the study was about and when penicillin became the accepted treatment in 1947, none of the participants were treated.  In addition, the government took active steps to prevent any of the participants from being treated in a study that only ended in 1972 after leaks to the press caused widespread public outrage.

Tuskegee Syphylis Study

The study, which lasted for 40 years included only sporadic clinical reexaminations when a Public Health physician came to Tuskegee and denied the individuals any form of anti-syphilitic therapy. In fact, in 1942 when it was brought to the attention of the then Assistant Surgeon General, Vonderlehr that some of the syphilitic subjects were being called for examination prior to induction into the Armed Forces and were being directed to undergo treatment systematic steps were taken to preserve the investigation. To prevent the draftees from receiving anti-syphilitic treatment, the investigators provided the Macon County Selective Service Board with a list of 256 names of men under the age of 45 years who were to be excluded from the list of draftees needing treatment. The Board agreed to exclude these men. Furthermore, when the modern-era of anti-syphilitc therapy began in 1943 with the introduction of penicillin as an effective drug, the Public Health Service did not use the drug on the Tuskegee participants unless they asked for it.

Today, once again in America, under a government controlled program, dialysis patients are the subject of intense study, but at present, only approximately one percent of us have access to optimal hemodialysis delivered in the comfort of our own homes.  A recent article quantitating mid arm muscle mass and survival concluded with the following statement:

Mid-Arm Muscle Circumference and Quality of Life and Survival in Maintenance Hemodialysis Patients

Conclusions: Higher MAMC is a a surrogate of larger LBM and an independent predictor of better mental health and greater survival in MHD patients. Sarcopenia-correcting interventions to improve clinical outcomes in this patient population warrant controlled trials.

American dialysis patients have a worse projected survival at time of diagnosis and intervention than the average breast cancer or prostate cancer patient.  Although the need for confirming treatment options is real, we already know much on how to impact survival in a cost effective package that somehow never translates into actual patient care.  I could easily list dozens of well done observational dialysis studies that have a similar conclusion for more study, yet the mortality rate in American dialysis patients remains unchanged for decades.  It is time to implement and not simply study effective measures now as many patients do not have the time to wait for a randomized and controlled trial to confirm what we already know.  

The deaths of those poor sharecroppers allowed to die for the sake of knowledge in the Tuskegee study haunts us today as we watch another government controlled patient population languish while we do nothing to change their fate.  There is not a single nephrologist today in America who could not immediately impact all of his patients by the simple stroke of his prescription pen.  Yet, instead, the American nephrology community continues to wait for the randomized and controlled studies that will likely never come. I would hope that the American academic nephrology community would not only call for more studies, but better yet, call their nephrology colleagues to action. Lives are lost daily because we have yet to act upon that which we already know.

AEI publishes another kidney-centric call for an organ market

By Bill Peckham

The American Enterprise Institute is out with another call for an organ market. Our Deeply Unethical National Organ Policy by Harold Gershowitz (recipient) and Amy Gershowitz Lask (donor) is a full throated call for kidney donor reimbursement. They even suggest a figure, $20,000.

The piece is aggravating for a number of reasons but the most aggravating part is that the authors view the issue as exclusively a kidney issue.

Kidney transplantation is not walled off from the rest of medicine. Change the structure of the kidney acquisition/transplant process, and you change the structure of medicine. Most particularly by paying for kidneys you change the system that has developed for the acquisition/transplant of other organs and tissues.

If a kidney from a living donor is worth $20,000, what's a postmortem kidney worth? How much for a postmortem liver? Postmortem donation of hearts, livers, lungs and all manner of other useful tissues rely on altruistic donation. If body parts become commodities what will it mean for all the people waiting for postmortem donations? I think the needs of people waiting for irreplaceable body parts (e.g. hearts, lungs, liver (mostly)) should be considered before the needs of those waiting for a kidney.

Have the authors spoken to the relatives of postmortem donors, the ones who had to make the decision to donate, and asked how compensation would have effected their decision? I have. The ones I've spoken to were repulsed by the idea. An altruistic donor system can't coexist with a paid donor system, it's one or the other. We will lose more than we'll gain if we allow kidneys to be sold.

DSEN Goes To College

By Peter Laird, MD

Those that contribute to DSEN strive to find interesting topics and articles to comment on in the realm of all aspects of chronic renal disease advocacy ranging from prevention, to the various renal replacement options.  I have enjoyed the two recent posts by Anna Bennett on renal transplantation issues (here and here ) and look forward to her further comments on this important issue (here).  

Interestingly, Bill sent me a link to an assignment using one of my posts.  My command of English is such that I look forward to the days that Bill does not raise his great red pencil to my posts and I get through unscathed.  After all, I am a doctor and Bill is the writer. So I was greatly surprised to see my essay When Altruism Isn't Moral isn't right as part of a college level English writing class. Weblog 5 Assignment:

Print out the following essays and read both with a pen or pencil in hand. Annotate as you read, making marginal notations about each text's main idea, thesis, supporting evidence, places where you agree or disagree and why, unclear or confusing passages you want to reread, unfamiliar words or phrases you want to look up later, memorable images, comparisons, or metaphors.

• When Altruism Isn't Moral By Sally Satel
• When Altruism Isn't Moral isn't right By Peter Laird, MD

After you have read the essays, write a blog entry of at least 300 words in which you summarize what each writer is saying about the effects of the Internet on reading and writing and explain whose position you agree with most. Give reasons and examples to support your position.

I have sent an email to Professor Jolemore inviting comments and perhaps even displaying the best pro and con essays here at DSEN on the issue of payment for renal donation from her class.  

To date, DSEN has placed 66 posts in the transplant category covering many aspects of this topic from renal transplantation medical complications to the medical ethics of renal transplantation in a substantial body of literature, much of which preceeded the article in question. I did not address many of the other complex renal transplant issues related to a paid organ donor system for sake of brevity of this post and the fact that I had covered that aspect in several prior posts (examples: here, here, and here). 

Making the point that altruism is immoral is a large task for Dr. Satel to achieve, especially given the case that she chose to highlight. The former Christian missionary Matt Thompson applied the virtue of altruism in one of the greatest stories of selfless sacrifice in response to the simple plea of a man in need.  Dr. Satel's accusation that this was an immoral act on the part of the Kaiser transplant surgeons is not in my opinion supported by the facts. 

If we are going to stand on strong arguments in the debate of the merits of one renal donation system over another, it must first be predicated on the truth and not in prejudicial presumptions shown to be without merit. I found another article discussing the ethics of this case that may be quite instructive to all interested in this debate and it offers a third view for the students in Dr. Jolemore's class to consider. 

ORGAN TRANSPLANT REQUIRED BONDING BEFORE SURGEONS WOULD PERFORM A KIDNEY TRANSPLANT, THEY WANTED THE DONOR AND THE RECIPIENT TO GET TO KNOW ONE ANOTHER:

Medicine's "do no harm" principle requires doctors to justify performing risky surgery on a healthy donor. The closer the relationship, "the more medicine feels comfortable saying, We'll subject you to risk,'" said University of Pennsylvania bioethicist Arthur Caplan.

But what is an acceptable relationship between donor and patient, and who defines it? Is it ethical if some people "jump ahead" of other, sicker patients on organ waiting lists simply because they are able to find a donor?

Some transplant programs do allow strangers to donate organs after rigorous medical and psychiatric screenings. Others, however, restrict donations to family and close friends, relying on a proven bond to justify the risk. Strangers too, they worry, might have mental problems or might be secretly paid, which is illegal in the United States.

"Kidney donation is not like giving blood," said Dr. John Scandling, medical director of the adult kidney and pancreas transplant program at Stanford University Medical Center. "It's major surgery. You can die."

The best that those in favor of the paid donor system can use as an example on a large scale is that of Iran. 

Unfortunately, Iran excludes patients over the age of 50 as well as women.  Further, we only have data from a few selected medical institutions in Iran and not the entire system as we do in America with UNOS. In addition, there is evidence that most of the donors in the Iranian system would not donate a kidney again if they could do it over. If all we have to date are the examples of Iran and what I believe is a misguided and prejudicial depiction of the Sonny Davis and Matt Thompson story by Dr. Satel, then simply telling every one that there is an organ shortage so we need to pay donors is not offering a viable solution based on evidence.  The debate continues as does education. Let both have the basis of unbiased truth leading to the best outcomes.

(This discussion is the opinion of the author and DSEN on the complex issue of paid renal donation. DSEN welcomes dissenting opinions in the comment section below)

Why Urea?

By Bill Peckham

I took a look at the Dialysis & Transplantation article RenalWEB highlighted over the weekend, Hemodialysis Adequacy: A Review. The editor of RenalWEB has a professional background that gave him a front row seat when the dialysis community took the wrong turn in the '80s and embraced urea removal as an important measure  of dialysis "adequacy". He could see that whatever the intentions of using urea, in practice it was misunderstood and misapplied. I'm glad I read the review but I found it frustrating because it tells the how, but not the why. Why urea?

The review begins by noting that in the early years the correct dose of dialysis was measured by determining the amount needed to keep the patient "alive and relatively asymptomatic". Aside from the apparent redundancy in this definition, it seems about right. If a dialyzor is asymptomatic then they are getting an adequate dose of dialysis. I'll go with that.

So how did we go from there, to relying on measuring the clearance of a "small electro-neutral solute"? A solute that is so easy to remove that the review notes the treatment's ability to remove urea "cannot be extrapolated to" the removal of things that actually matter. The review never says it, but the urea solute, the object of all this testing, has no bearing on the health of the person with CKD. It's odd the review doesn't mention it but urea is basically harmless. It's a marker.

Urea is such a basic and easy to remove solute that healthy kidneys easily control its level in the blood. When blood urea levels are seen to be increasing, a physician knows that there must be a serious problem. If your kidneys aren't controlling urea, there is little chance that they are controlling the blood levels of things that matter, solutes that, unlike urea, directly cause ill health. Solutes like potassium, phosphate or b2-microglobulin. Urea is a useful marker for identifying people with kidney disease and for people who use dialysis, if your urea level is high, you need to be dialyzed. But that's about the limit of urea's usefulness.

It tells you there is a problem but it is not the problem. It's as if the fire department, at the sight of smoke, would race to the scene and point their water hoses in the air to draw the smoke out of the sky. Some water would no doubt land on the fire, the problem, but not enough because they would not be focusing their resources on the real problem. Fighting severe kidney disease through urea control is like fighting a fire through smoke control, you look busy but you're missing the point. And more importantly, you're being ineffective in fighting the real battle which can be, if not won, fought to a draw.

The review leaves the big urea history questions unanswered. If urea was the solution who was defining the problem? We had a good measure - no symptoms of chronic kidney disease. Who didn't like that measure? The editor of RenalWEB highlights in the editor's comment, (very close to a blog post, just do it already), the role of corporations in making and selling ways to measure urea, but I would point to their more important role in wanting a measure like urea in the first place.

The only interests served by measuring urea are business interests. Urea is easy and inexpensive to measure. Urea is easy and inexpensive to remove. Badda bing! as they say.

For dialyzors in the South emergency room is dialysis unit of last resort; Dialysis aid headed to Haiti

By Bill Peckham

RenalWEB links to what promises to be a more hopeful story on the dialysis situation at Atlanta's Grady Hospital. On reading the article, however, it is clear that there is still a way to go for a solution. I first heard about the situation at Grady in September. Back then they had 60 patients who were insurance never, Medicare/Medicaid never. It comes down to a state decision as to whether routine dialysis is a covered service under Medicaid or whether it is uncovered.

The Atlanta Progressive has done the most complete reporting on the situation (my emphasis):

As previously reported by APN, Grady sent letters to uninsured patients informing them of the closure and provided them a list of nearby private dialysis providers along with three options for future care: return to their country of origin, move to another state where they may qualify for emergency Medicaid services, or seek treatment through an emergency room.

As is often said if you show up at an emergency room with a medical emergency, you will get medically stabilized regardless of your insurance situation; the hospital will probably get some payment through Medicaid or a state level Medicaid-like-program of federal healthcare cost sharing.

Given that universal emergency room entitlement, most states allow Medicaid to pay for routine dialysis. Correctly, seeing dialysis, even routine outpatient dialysis, as sequential emergencies. Point of fact, as soon as you finish your dialysis treatment you will die unless you get dialysis again soon, so when you need dialysis it is an emergency or a day or three away from being an emergency. The problem of course is political. It is politically very unpopular to pick up the healthcare tab for illegal immigrants who are the majority of people who do not routinely qualify for Medicaid. And second point of fact, dialysis is not any where close to being universally available in our hemisphere, let alone in this world.

The reason that there are dialyzors from all over the world, in the United States without citizenship and/or insurance, is because dialysis is not widely available in their home country (e.g. central America, sub Saharan Africa) or in the US, dialysis is better (e.g. Mexico, Philippines). As individuals we understand the impulse, but as a society we are worried for obvious reasons. We can not, as a country, be the world's dialysis provider.

There is the issue of moral hazard. If we provide dialysis, people will come here to receive it. Far less than half the population of the world has any access to dialysis or transplantation. As a country we have to be clear eyed and direct aid where it will do the most long lasting good for the most people. There are huge areas of the globe where people need drinking water; on our national aid priority list, dialysis can't come before drinking water.

Right now in Haiti, struggling to get its footing after the devastating earthquake, the question of dialysis is in the news. Our impulse is to help, so we applaud the efforts of the dialysis community to fund emergency services. Yet before the quake, I believe there was a single dialysis unit in Port-au-Prince serving the entire country of 9 million Haitians. With a population of 9 million, by US standards there should have been 10,000 Haitian dialyzors (if not more, given risk factors for CKD). Is the US dialysis community going to stay in Haiti, after the next disaster moves Haiti out of our collective consciousness?

Certainly I hope the equipment on the USNS Comfort is put to good use. There will undoubtedly be people with an acute need for dialysis that will benefit greatly. They will have a chance to live and rebuild. And certainly the previous dialysis infrastructure should be rebuilt and enhanced, to the degree the community can sustain. But the need is greater than we, the United States, can sustain. That feels nearly as hard to accept as the text messages from under the rubble, sending out unanswered calls for help. It is hard to accept.

We want to help. We know dialysis. But right now, right there, dialysis isn't the right answer. Not when we can't help all the dialyzors of Georgia, and Florida, and ...

Practices alleged in lawsuit against DaVita are damaging to entire CKD community

By Bill Peckham

RenalWEB has late breaking news that the United States of America is joining a whistle blower suit is proceeding with DaVita as the only defendant. RenalWEB has the 52 page amended complaint (PDF link) and points to pages 15 to 26 (RenalWEB's editor notes feeling " ill when reading" those pages). I haven't read all the gory details but point 40 of the complaint  seems to succinctly sum up what is alleged:

40. Through training, review of patient records, and the drafting of treatment protocols, Amgen taught DaVita’s facilities about the “increased revenues” and “financial impact” arising from the increased utilization of Epogen.

These are credible charges that are inline with reports, and observed results.

This hurts us all. What is described is experimentation without consent. For example, experiments to determine how changing protocol q, increases EPO use without too great changes to measured reported hct.. Un-consented experiments, designed to discover optimal revenue. This is damaging to people doing real renal research. DaVita's optimal revenue research, is damaging to those doing optimal dialysis research. It is nauseating.

These allegations erode the trust that has to be present to achieve optimal dialysis not just at DaVita, but throughout the provider community. This is a set back for us all.

UPDATE: In False Claims Act cases, an individual can file a suit on behalf of the U.S. and the U.S. is included as a listed plaintiff. I misrepresented the US government's participation in the initial version of this post.

Satel's review of Fox and Swazey's Observing Bioethics is telling

By Bill Peckham

Sally Satel has a review of Observing Bioethics by Renee C. Fox and Judith P. Swazey, posted on The New Republic's new website the Book. Beginning over 30 years ago Fox and Swazey have study bioethics, through an in depth study of organ transplantation and chronic dialysis first in in their seminal book the Courage to Fail and then in Spare Parts.

Satel's review, The Right (and Wrong) Answers, is striking in its dismissiveness of bioethics:

American bioethics was born out of a desire to be relevant.

Ah, no. Bioethics was born out of a desperate need. 

While bioethics has been around for as long as humans have been sentient, in the sense of how to treat the dead and dying, bioethics really came to the fore with the advent of chronic dialysis and the decisions faced and made by Belding Scribner, in the early '60s. This is thoroughly documented in Fox and Swazey's earlier books and informs their concerns about modern efforts to use bioethics for political advantage and co-opt the hardest cases to create culture war cause célèbres (see Schiavo, Terri). And one should remember that it is Fox and Swazwey's early work that  overlaps Satel's well developed interest in creating an organ market.

The underlying problem Satel has with Fox and Swazey's work is the "Gift Exchange" that Fox and Swazey first document in '70s. The Gift Exchange is as relevant today as it was then and then as now, it undercuts the supposed moral imperative of establishing remuneration for kidney's, something which Satel is wholly in favor (optimal dialysis also undercuts the supposed imperative, but Satel has never addressed that point). In her review Satel offers:

Though clearly fond of the bioethicist-physicians, bioethicist-philosophers, and bioethicist-legal scholars they interviewed, Fox and Swazey describe themselves as “critical of what we regard as the field's deficiencies and blind spots.” They identify these as the use of dumbed-down teaching formulae, an insensitivity to cultural differences, and the tendency of American bioethicists to emphasize “individual rights, and rationality” instead of “community, and common good,” which are the values that Fox and Swazey  favor.

Here is Satel's core libertarian beef with bioethics, the idea that when society's collective needs are weighed against an individual's right to act as they wish, the individual is not given more weight. 

As recently as the Monday before Christmas Satel wrote:

Sadly, the transplant establishment insists that sick people languish on dialysis for years or die waiting for a kidney. They fear, on one hand, that the patient might remunerate someone for saving his life and, on the other, that any donor in financial need can’t possibly make a rational decision about his own best interest.

The problem isn't with the transplant establishment or bioethics, which holds the myopic in check, the problem Satal has is with libertarianism's inability to make her case.

Is Evidence Based Medicine the Main Barrier to Optimal Dialysis in America?

By Peter Laird, MD

Since the advent of hemodialysis availability in the 1960’s, practitioners have searched for the most optimal way to utilize this life saving technology.  Historical reviews of the pioneering days of hemodialysis reveals experimentation on how frequent and how long we should administer dialysis to patients in need of renal replacement therapy to optimize outcomes.  Surprisingly, the modalities that we now refer to as new and novel were actually described and utilized very early in the course of dialysis experimentation.  Dr. Shaldon was the first nephrologist to prescribe home, nocturnal hemodialysis in 1964 both in London and in Germany followed shortly by Dr. Scribner in Seattle. Dr. Bernard Charra continued overnight hemodialysis in Tassin, France in the 70’s and 80’s with excellent results that were largely overlooked for decades.

The modern era of home, nocturnal hemodialysis reemerged in 1993 in Toronto, Canada by Drs Robert Uldall and Andreas Pierratos. The published observational data from multiple centers utilizing home, nocturnal hemodialysis 3-7 times/week reveals improved anemia control, normalized blood pressure, normalized mineral bone metabolism, normalized functionality and reduced mortality and morbidity compared to conventional incenter dialysis. A recent study with twelve years of follow up showed equal survival with daily, nocturnal hemodialysis as compared to cadaveric transplant. Despite an abundance of observational data and practical experience from Canada, Australia, New Zealand and other nations that have adopted the concept of optimal hemodialysis modalities, America continues to view optimal dialysis modalities with skepticism.

Today, America stands alone as the only developed nation not convinced of the overwhelming evidence that more frequent and longer duration dialysis saves lives.  America also stands alone with an alarming mortality rate among dialysis patients 2.5 times higher than Japan. American healthcare continues to insist on randomized, controlled trials showing the benefits of these alternative dialysis strategies over conventional incenter care even though they readily admit that it is impossible to randomize the 3000 to 5000 patients needed for such a study.  The Frequent Hemodialysis Network is actually unable to recruit even 250 patients for their ongoing nocturnal dialysis study let alone a study with enough statistical power to show a 30% difference in mortality from conventional incenter dialysis. Patients that are knowledgeable of the benefits of extended dialysis are routinely denied access to these life changing home therapies by their insurance companies who allege a lack of evidence of their benefit.

Group Health - Clinical Review Criteria:

Frequent Home Dialysis, Nocturnal or Short Daily
There is insufficient evidence that home nocturnal dialysis improves important health outcomes compared to in-center dialysis. An RCT found improvement in LV mass and phosphate level, intermediate outcomes, and mixed findings in QOL. There is weak evidence from a single cohort study that nocturnal dialysis lowers the rate of dialysis-related or cardiovascular- related hospitalizations. In this cohort study, all-cause hospitalizations did not decrease significantly.  

To date, we have the benefit of only one small RCT on nocturnal hemodialysis which confirmed many of the findings of prior observational studies showing significant benefits of more frequent and longer duration dialysis. America continues to stand alone in it’s call for the highest academic standards of dialysis healthcare, while paradoxically delivering the worst dialysis outcomes anywhere in the civilized world.  America’s search for the holy grail of dialysis evidence based medicine with an optimal randomized  controlled trial that is admittedly impossible to ever complete is nothing but tilting at windmills. 

While America charges ahead with protests of academic purity before accepting the proven benefits of optimal dialysis, patients are needlessly dying at the hands of our own nephrologists who blindly forgo these lifesaving treatments.  While the world embraces optimal dialysis, America instead worships at the altar of optimal randomized controlled dialysis trials which shall never be completed.  It is time to end this quixotic quest, we must stop fighting the windmills of academic purity. Instead let us be inspired by the great pioneers of dialysis in the fight against our true foe, the uremic milieu of too little dialysis and simply ask the dialyzed what frequency and duration of dialysis makes them feel better.

Transplant surgeons do not support cash payments for organ donation

By Bill Peckham

Nephrology Times reports that a survey of transplant surgeons shows that they are mostly against cash payments to donors or their families to encourage deceased or living organ donation, however, there is a large gray area. The survey was conducted by the American Society of Transplant Surgeons towards the end of last year:

Most of the respondents were surgeons, practiced in the United States, had less than 15 years of experience in transplantation, and had a primary focus on abdominal organs.

In terms of government-regulated strategies to increase living organ donation, 76.8% of respondents supported payment for lost wages, 72.0% payment of health insurance premiums, and 64.0% an income tax credit.

Payment of life insurance premiums was favored by a slight majority-55.5%-and a contribution to a charity of the donor's choice by a slight minority-44.5%. Cash payment to the donor received the least support-20.1%, with 61.5% of respondents opposed to such an incentive.

Like all these proposals there would be a lot to work out in the details - saying you'll pay insurance premiums can mean a lot of things. 

What level of insurance would you be prepared to fund? For how long? Often the solution would be to provide vouchers for people to use towards an insurance policy they select but it isn't clear to me why this is acceptable if pure cash payments are not. I think accepting one (pay for insurance) but not the other (pay cash) shows transplant surgeons are conflicted.

The survey respondents are acknowledging that cash payments might not feel good in practice; that they can imagine not approving of the decisions donors are making. But what to make of those that said yes to insurance but no to cash? Is the appeal that insurance would obscure bad decision making? The thing about altruistic donation is that we (society) approve of the decision. Are we ready to support living organ donation when we think the donor has made the wrong choice? Transplant surgeons aren't ready.

The New Medical Ethics: Population Based Outcomes

By Peter Laird, MD

The debate over health care reform out of Washington DC is underscored by a new medical ethics that is seldom discussed  and even fewer that understand it in the general public. It is called population based medicine. Harvard medical students recently protested the closing of their Primary Care Department and instituting instead the Department of Population Medicine as several other medical schools have already done previously. The ivory towers of Harvard were never the champions of primary care as evidenced by the meager $200,000 funding to their now defunct primary care department which is essentially the salary of one primary care physician and one primary care nurse.

My first profound experience with this new medical ethics came several years ago when I was reviewing a newly revised tuberculosis treatment guideline from the CDC. Isoniazid (INH) is the most often prescribed medication for latent TB which most would know simply as a positive PPD/TB test. For the majority of my medical career counseling patients on the risk, benefits and alternative treatment options of latent TB, I had followed a very standard risk protocol based on a 1978 study by Kopanoff  finding significant risk based on increasing age:

According to a USPHS study reported by Kopanoff and workers in 1978, of 13,838 patients on prophylactic isoniazid therapy, hepatitis was uncommon in patients younger than 20 years and occurred in 0.3% of patients aged 20-34 years, 1.2% of patients aged 35-49 years, and 2.3% of patients aged 50-64 years (see chart). Although the rate of hepatotoxicity is lower in more recent studies, age remains an important risk factor.

In fact, the risk of INH treatment based on age listed above was exactly the information that I provided since 1993 to all of my patients with a positive TB test. Several patients chose not to take the prophylactic medication after coming to an understanding of the number of patients who will at some time develop active TB versus the number of patients that will possibly develop at times fatal INH induced hepatitis. However, current CDC latent TB treatment guidelines no longer mention INH risks in their treatment recommendations. The reason, we are now treating the herd in an attempt to eliminate or mitigate the effects of Tuberculosis in our entire population at the expense of a few individuals who may die from IHN induced hepatitis. The risks to the individual based on their age is now supplanted by the risks to the population. In other words, the CDC has switched from the ethics of treating the individual to the ethics of treating the population. This is only one of many examples of the new medical ethics that could be cited today.

The current debate on health care reform in America is simply the debate on completely changing from that of treating the individual to that of the population as a national choice. The healthcare systems of Canada and England have long since shed the medical ethics of Hippocrates (PDF link) in serving the individual patient to the maximum extent of the talents of the physicians to that of population based outcomes that often deny the individual treatments that could extend, prolong or improve their remaining life.

When I graduated Boston University School of Medicine, my class chose the Oath of Maimonides instead of the Hippocratic Oath. Staying true to this oath and having suffered myself in pain, it would behoove the American physician of today to truly recall the true calling of a physician to his individual patients.

Oath of Maimonides
The eternal providence has appointed me to watch over the life and health of Thy creatures. May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.

May I never see in the patient anything but a fellow creature in pain.

Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements.

Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today. Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling.

To understand this new medical ethics of population based outcomes is to understand what the true healthcare reform debate in Washington DC is all about. As evidenced by the example of the new latent TB treatment guidelines, the new medical ethics is already entrenched in our institutions and most especially, in all of the new medical school graduates. No wonder many patients wonder why they are not receiving the same care as they once did from those of us in the medical profession with much gray hair if we have any hair at all. As for me, I will always remember each time I self cannulate with a large 15 ga needle that I am simply a fellow creature in pain.

When Altruism Isn't Moral isn't right

By Peter Laird, MD

When Altruism Isn't Moral is the provocative article by Sally Satel earlier this year relating the experience of an altruistic donor who was originally turned down by the Kaiser renal transplant team who were simply keeping their fiduciary and legal duty to assure that the offer was not for financial gain. Dr. Satel uses this as the basis for ascribing the initial rejection of the altruistic offer as evidence of immorality in allowing Sonny Davis to "languish" on dialysis.

In early 2006, Matt Thompson of San Jose, California, decided to give a kidney to Sonny Davis, a 65-year-old physicist living in nearby Menlo Park. Thompson was moved to donate after reading an impassioned plea from Davis’s wife, who had sent 140 letters to friends and relatives asking them to consider helping her husband. One of the recipients happened to be a colleague of Thompson’s, who passed it along, thinking Thompson just might heed the call. Sure enough, Thompson, a devout young Christian and former missionary, contacted the transplant program to volunteer.

But the transplant program at Kaiser Permanente of Northern California turned him down. Had Davis been a family member or a good friend, he would have been acceptable to the program. Thompson was frustrated and surprised, but he and Davis were determined to do the transplant. According to the San Jose Mercury News, they “knew they had to forge a bond that would assure Davis’ surgeons that Thompson was donating his kidney for the right reasons.” This meant, among other things, that Thompson would not profit financially. So the two developed a relationship and convinced the transplant program that no money was secretly being exchanged. On November 14, 2006, the transplant finally took place.

I am aware of California's aggressive penchant for prosecuting physicians for even the most minor infractions, let alone a serious possibility such as illicit black market organ sales.  Any physician in California that does not document appropriately their compliance with all rules and regulations is at the mercy of the California Medical Board should any inquiry take place.  Unlike our American constitutional rights of being innocent until proved guilty, physicians are overwhelmingly assumed to be guilty if the documents do not prove their innocence explicitly. In our business, if it was not written down and documented, the standard of evidence is that it is assumed to be in the states favor when an issue is in doubt. For doctors, not saying something is used as proof of guilt while in the American criminal jurisprudence, staying silent is not used against a defendant. American doctors do not operate under the same legal expectations that the ordinary citizens of America take for granted.

Understanding this, the example that Dr. Satel uses fails more when she reports that the transplant did take place before the end of the same calendar year it was requested. For many transplant systems, it takes several months of testing and appointments even without questioning the true motives of a living donor, thus there was likely no substantial delay in obtaining the transplant in question.

The recent headlines of a longstanding black market in organ sales operating in the United States is a shocking revelation that rescinds the State Department's long held disdain for the possibility of its existence.  Since the 1980's, such accusations were treated as simply urban legends and dismissed for any serious consideration by the Feds. Today, we are only beginning to learn of the full extent that illicit black market traffickers operate here in America.

Once again, Dr. Satel who is an actively practicing physician herself is apparently overlooking the obvious fiduciary and legal obligations that all physicians operate under when she attributes carefulness as an example of immorality.  I applaud the Kaiser physicians who were thorough enough to ask for proof of the authenticity of the altruistic donor's offer. This is in no manner an example of immorality or a failure of altruistic donation.  It is a supreme example of a system working well to benefit the patient and assure the integrity of the American transplant services.  Dr. Satel once again confuses the issues with this alleged example of immorality especially in light of the latest headlines on organ trafficking in the United States.

The fact remains that if all transplant surgeons were as diligent in checking into the authenticity of altruistic renal donations as the much unfairly maligned Kaiser physicians were who treated Sonny Davis, alleged thugs like the ac cussed Levy Izhak Rosenbaum would have long ago been put out of their dark business.  It is quite hard to stand firm against corruption and in doing so, a simple request to offer proof of the validity of a rare offer is proper application of medical ethics.  My complements to the Kaiser physicians who requested, accepted and amended the offer of a kidney by Matt Thompson. This is a wonderful story of the system working well, it is not and was not an example of Altruism being immoral.

It is my personal opinion that Dr. Satel should have informed her readers of the special ethical and legal obligations transplant surgeons face before maligning unfairly the Kaiser transplant team in question. This does great disservice to the cause of increasing renal donation that Dr. Satel so actively promotes. She further does not report on the usual waiting times between request for altruistic renal donation and actual donation. It is my personal opinion that any medical doctor who writes and advocates for unusual and provocative medical solutions is acting in an immoral manner when they subvert the universal fiduciary obligations all doctors act by according to the laws and ethics of the state and country that they practice.

I stand in support of the Kaiser transplant team and wish that Dr. Satel would spend more time educating the lay people that support her views about the duties and obligations that led the Kaiser surgeons to act in the manner in which they did. Calling this example of altruism immoral isn't right. It is my opinion that this accusation of immorality against the Kaiser transplant team in question is even more egregious when we understand that Dr. Satel is likewise the beneficiary of an altruistic donation that took her months to arrange with one donor that later refused their original offer to her. Sometimes, the test of time is the only true test of a true altruistic offer. Once again, Dr. Satel more than anyone I know should be aware of this simple fact and reflect that in her writings.

(For further information on this issue see DSEN Goes To College)

Reasoning With Satel: Rich Man’s Disease, Poor Man’s Plight

By Peter Laird, MD

Sally Satel is a medical doctor who also suffers from CKD-5 which she chose to treat with an altruistic living donor renal transplant from Virginia Postrel. Likewise, I am a medical doctor suffering from CKD-5 but we differ in that I chose to treat my CKD-5 with home daily dialysis.  Both treatment options entail risks and benefits but the key is that both transplant and dialysis (optimal or otherwise) are treatments, not cures. Neither of us shall see a complete cure unless we one day have a medical breakthrough that allows successful transplants without the need of immunosuppression or some other yet to be imagined technology.

There are many like myself and Bill who have seen an improved lifestyle from daily home dialysis. It likewise is not a cure, but simply another renal replacement option. A lot has been written on how to increase altruistic donations which is a worthy goal but the most surprising statements that I have noted come from the literature on creating an organ market to eliminate the wait list that plagues Americans waiting for a renal transplant.  

The most troublesome argument that I have encountered among those that promote an American market based organ procurement system is their denigration of the altruistic renal donation system. This is followed by their advocacy of replacing the current framework with a new ethical paradigm where altruism is called immoral and what has long been considered immoral is now called moral in regards to payment for organs. The unspoken and unwritten assumption underlying these proposed new ethics is the ascription of an implied right, an entitlement to someone else’s kidneys. They contend that morally they have a new right to healthy kidneys, a right to healthy kidneys as a commodity to be purchased like any other commodity:

The woeful inadequacy of our nation’s transplant policy is due to its reliance on “altruism.” According to the guiding narrative of the transplant establishment, organs should be a “gift of life,” an act of selfless generosity. It’s a beautiful sentiment, no question. In fact, I, myself, am a poster girl for altruism. In 2006, I received a kidney from a (formerly) casual friend who heard secondhand about my need for a transplant. In her act, there was everything for me to gain, and, frankly, not much for her. My glorious donor was moved by empathy and altruism as purely as anyone could ever be.

Yet, it is lethally obvious that altruism is not a valid basis for transplant policy. If we keep thinking of organs solely as gifts, there will never be enough of them. We need to encourage more living and posthumous donation through rewards, say, tax credits or lifetime health insurance.

Changing our current altruistic based organ procurement system for a commodity based system in my mind is predicated on an unspoken right and claim to other people’s organs when they are considered anything but a gift.  Perhaps this sense of entitlement is a vestige of our colonial past where the rich man was unduly entitled without regard to the entitlement's cost to the poor man. Today, renal disease is a disease of the rich nations that can afford sustained renal replacement options and it is the plight of the poor man that simply dies from their illness in nations that lack the basic medical treatment options we have come to think of as a right and an entitlement.

In recent years, long wait lists have led to illicit and illegal organ markets in China, Pakistan, India and the Philippines.  Once again, the burden of the rich is placed on the poor.  Many have spoken out against these markets but some who advocate for a market based organ procurement system here in America fail to understand the underlying inequality that a market based system will inevitably lead to based on wealth, privilege and poverty. Satel even considered becoming a transplant tourist herself:

In desperation, I briefly considered going overseas to become a "transplant tourist." I heard of people needing kidneys who turned to advertising: kidney-wanted ads, billboards and Internet sites.

Satel is paradoxically compelled to protect those that she seeks to enroll in vending their organs by reducing the rewards to intangible compensations such as health insurance, retirement payments or other such payment in kind, but she does not support direct cash payments which could lead to undue economic coercion of the socially disadvantaged that she "in desperation" would have willingly done herself.

Many people are uneasy about offering lump-sum cash payments. A solution is to provide in-kind rewards, such as a down payment on a house, a contribution to a retirement fund or lifetime health insurance, so the program would not be attractive to people who might otherwise rush to donate on the promise of a large sum of instant cash.

Satel is already subverting her entire arguments to those that are deprived of retirement and health insurance which is indeed the financially challenged more so than those that have wealth and privilege. Once again, attributing these rewards as an inducement to vend your organs implies a class of people that are impoverished compared to the wealthy who would not find such inducements any value in considering whether to vend a kidney or not.

In 1863, America instituted conscription to support the North's war effort but allowed another person to take their place by payment or substitution:

These two practices were major points of contention among the general public and led directly to the slogan "rich man's war, poor man's fight."

In my opinion, Satel's bizarre logic to support in kind rewards instead of cash incentives for the immoral act of making organs simply another commodity is not a compelling argument. Satel further fails to inform her readers of the alternative daily dialysis treatment options which is in violation of the ethics of informed consent that she must adhere to as a medical doctor.  As a physician, I contend that making an ethical argument to subvert our current altruism based organ donation model without informing her readers that daily dialysis has an equivalent survival to cadaveric transplant is unethical and immoral.  It is my opinion that the commodity system that Satel has promoted aggressively for several years is nothing more than the poor man's plight for a rich man's disease.  

We don't need an organ market to cure conventional dialysis

By Bill Peckham

This organ market issue was not one I imagined covering when I started this blog but looking through just the 50+ DSEN posts categorized "Transplant" it turns out that we've written a number of relevant posts (and there are probably others since my post categorizing is inconsistent). So what is it about DSEN that attracts people who don't think paying for kidneys is a good idea? And can I tie that in to why I think Postrel misappropriated Halcomb's views?

I think it is because DSEN authors have all experienced unconventional, healthier doses of dialysis. We understand that renal transplants cure conventional dialysis. That is how Postrel and others have presented the case for an organ market, as compared to conventional dialysis. The cost savings are compared to conventional dialysis. Transplant's increased sense of well being is as compared to conventional dialysis. The mortality advantage is as compared to conventional dialysis. It is not a cure for Chronic Kidney Disease, it's just another treatment for CKD; its a cure for conventional dialysis.

The problem as Postrel sees it is how do we improve the lives of the 80,000 people waiting for a kidney who either face or are languishing on conventional dialysis? Oh and save Medicare money. Of course the first thing we at DSEN all say is hey! What about the hundreds of thousands of additional people who don't want to languish on conventional dialysis? Why just try to help a small subset of the population? And why save Medicare money on just a small subset of the CKD5 Medicare population?

The next thing we at DSEN all say is wait - before you change the ethical structure of organ transplant to cure 80,000 people of conventional dialysis stop and consider other cures. I know that daily nocturnal hemodialysis is a very good method of renal replacement. All here at DSEN know that there are other ways to cure the problem of conventional incenter dialysis. Routinely offering every other day dialysis incenter, especially in combination with longer runs, would cure some of what is wrong with conventional dialysis. And higher doses of dialysis would save some of the hospitalization costs Medicare incurs when beneficiaries replace their renal function with nine hours of dialysis a week.

I can point to things Halcomb wrote that suggests he would share DSEN's point of view' and to Halcomb's October 2006 Nephrology News & Issues interview (PDF available to IHD members) subtitled NxStage machine leads to attitude change for one patient. I think anyone who has experienced an unconventional, healthier dose of dialysis would be against an organ market because of their dialysis experience.

There are libertarians on dialysis too but based on his dialysis experience I believe Halcomb would have known that the choice isn't between transplant/languish and die. His experience with unconventional dialysis is why Halcomb matters in this debate. He matters because he had experience with an unconventional, healthier doses of dialysis - Postrel using a quote from before this experience to bolster her case is not fair.

I and everyone who writes at DSEN support the idea of curing conventional dialysis. We can cure conventional dialysis for hundreds of thousands of people by changing what the term refers to. Speaking for myself I think conventional dialysis should be nocturnal dialysis at home, with the frequency worked out between the dialyzor and doctor. Three hour runs, three days a week should be offered only as a last resort, an appropriate use of today's conventional dialysis would be as palliative care for someone transitioning to hospice. As has been written and adopted as DSEN's position, optimal dialysis and transplant are complimentary forms of renal replacement. And both are cures for today's conventional dialysis. I don't see the need for the organ market solution.

Reasoning with Postrel: My Name is Bill

By Peter Laird, MD

In the last two years since starting on hemodialysis as my renal replacement therapy of choice, I have witnessed the provision of dialysis as provided in America largely by Medicare.  Often it is not pretty but it doesn’t have to be such a routinely violent process. It is not an issue with the dialysis modality in itself, rather instead in the lack of optimal dialysis as offered to patients world wide but not routinely here in America.  I am fortunate to not only be able to dialyze at home for the last month but to have been previously in a unit that achieved a 7% mortality rate in 2008.  That survival outcome is better than Japan’s leading average survival rate and is even more remarkable knowing the simple and easily repeatable practice changes that led to this result.

Bill Peckham recently engaged directly with Virgina Postrel in a discussion online on the magazine Reason's blog Hit and Run.  Bill rightly took umbrage to Postrel’s misuse of quotes from Bill “Epoman” Halcomb in her Atlantic magazine article, With Functioning Kidneys for All.  Reading the comment thread it seems clear that not only has Postrel unfairly characterized Bill “Epoman” Halcomb's thinking, but is now doing the same to DSEN's own Bill:

As for Bill Peckham, he may be content with life on dialysis, but many people are not. Yes, better dialysis would improve medical outcomes, but a transplant is far superior

I wondered first why Postrel so frequently misrepresents the views of people on dialysis named Bill. 

Bill Peckham, as most DSEN readers know, opted first for a living related renal transplant in 1988 from his brother.  Unfortunately, this graft failed by 1990 when Bill’s FSGS recurred in the graft kidney.  I have spoken with Bill and followed his writings for over a year and Postrel has failed to characterize correctly Bill Peckham’s personal journey with renal replacement therapy.  Bill has stated many times that he would love to be able to try another renal transplant but he declines due to the high risk of another failed transplant since his FSGS is believed to be still active.

It is a mischaracterization to say Bill is content with life on dialysis. Bill is not in any manner content with his plight. While he is eligible to request serial transplants - maybe the third time will take - his choice is to replace his kidney function with a very high dose of hemodialysis, preformed in his home, while he sleeps. That's an informed choice based on his clear eyed review of the situation. That is not simple contentment due to inertia. 

Worse yet is Postrel’s further comments in reply to Bill’s very reasonable and what I felt were restrained responses:

What you may not realize, because you're inside the world of dialysis, is that most people have not spent 5 seconds thinking about it. Dialysis is a "set it and forget it" entitlement. Medicare covers it, so who isn't affected ever has to think about it. And, as you well know, most dialysis is exactly the way I described it and not an easy thing under the best of conditions. You're just used to it.

I read this response from Postrel and simply could not understand her total disregard of Bill as a person and as sufferer of renal disease. 

To castigate Bill’s entire response and experience on dialysis to a cute phrase: “You're just used to it”, to do it in response to Bill’s testimony of his personal renal replacement journey, that is not the response one would expect from a nationally renowned author. Not only is the comment derogatory and unfair to Bill, but as a fellow dialyzor, I take umbrage with her pejorative remark to someone who volunteers in service to the CKD population covered by the Northwest Kidney Centers (NKC) and who volunteers as a very active dialysis advocate nationally.

Bill is the first patient to become trustee board chair for NKC.  This is a remarkable achievement for a position that is usually dominated by those in the medical field.  Bill is the most knowledgeable person I have ever encountered in the field of dialysis and the provision of dialysis under CMS.  Postrel’s comment completely underscores the insulting and dismissive manner in which dialysis patients have been ignored by the majority of the renal transplant community, not to speak of those who are standing up for what I believe are the unethical proposals of payment for renal donation.

If organ market advocates wish to use the argument that the usual dialysis care in America is terrible, then that is their choice. How dialysis is currently experienced by a majority of dialyzors is grim; that is well documented and not in dispute. However, these organ market advocates continually ignore the well established fact that optimal dialysis is available and cost effective without any changes to the law that they seek. If you base your argument on a fact - current dialysis practices are very hard to live under - then you are obliged to consider all solutions and then evaluate the solutions by comparing their projected impact.

Postrel’s comments become egregious when we consider that she will not consider the implications of optimal dialysis being equal in survival benefit to transplant. Simply stating that Bill is “used to dialysis” fails to acknowledge how hard Bill works at making dialysis work for him.  Bill undergoes nocturnal dialysis 4-6 times a week.  Bill eats well, he avoids smoking and he avoids undue stress with long walks with his dog and he takes his medicines as prescribed.  Bill further exercises and has maintained a full time job. He's dialyzed in over 20 countries.  Bill is an amazing member of our society as so many who know him will testify.  The fact that he accomplishes all that he does while treating his CKD5 with hemodialysis - alone, at home - is of even more credit to his enduring spirit.  

Bill "Epoman" Halcomb struggled for many years to attain optimal dialysis which unfortunately could not overturn the ravages of time.  Nevertheless, he has left a living legacy to the tributes of living on dialysis.  We must never forget the thirteen years he gained on dialysis that he would not have had five decades before.  The provision of dialysis in America falls behind the standards of dialysis throughout the developed world.  Who shall stand in the brink to bring this madness to an end?  I would expect those that understand these shortcomings to welcome all approaches that will save many lives, but in respect to the payment for organ supporters, they remain uniquely silent.  

Knowing the horrors of usual dialysis care in America should lead them to also support optimal dialysis at the same time that they wage their own battles to increase renal donation.  Yet sadly, not only do they not support publicly the improvement of renal dialysis modalities in America, it is my impression that they deliberately avoid the information showing how daily dialysis outcomes can be equal in survival to renal transplant. I am now finding that they may indeed consider people such as Bill Peckham and Bill Halcomb who advocated aggressively for optimal dialysis more of an enemy to their cause than an ally.  Unfortunately, they continue to misrepresent the association of optimal dialysis and renal transplant incorrectly as competing instead of complimentary treatment options.

Postrel is able to so easily dismiss Bill’s well framed responses by a cute phrase, “You're just used to it.”  My response to Virginia Postrel is simply, my name is Bill as well. He has lived the dialysis life and thrived.  It is an example for all to emulate.

Paying for kidneys is a shortcut to a dead end

By Bill Peckham

It isn't until the end of Virginia Postrel's nearly 5,000 word Atlantic article ...With Functioning Kidneys for All that the idea of paying for kidneys enters the discussion. For most of the article she is outlining ways to increase altruistic living donation: pointing to advances such as laparoscopic nephrectomies being much easier to recover from (I can vouch for that, nine days out and I had a full day today), and logistical solutions to match willing donors with compatible recipients.

As Postrel says we can all agree that swapping kidneys is a good thing but she continues what we really need to make the system work is money. We need to pay people to donate a kidney. Postrel comes to this conclusion after noting that one can imagine enough donors to meet the need through altruism (just look at how many Churches there are in the US) her point is that money would allow the system reach its potential. To Postrel the paired exchanges become just like a barter system and cash is how you make a barter system preform more efficiently.

True to a point but not so fast. Just because the exchange became complicated, involving multiple parties, does not mean the nature of the exchange changed. No matter how complicated the paired exchanges get they are still gift exchanges, not business transactions. Paying the donor would change the entire nature of the program. Kidney transplant is not walled off from the rest of medicine. Change the structure of the kidney acquisition/transplant process and you change the structure of medicine; most particularly the acquisition/transplant of other organs and tissues.

If a kidney from a living donor is worth $25,000, what's a postmortem kidney worth? How much for a postmortem liver? Postmortem donation of hearts, livers, lungs and all manner of other useful tissues rely on altruistic donation. If body parts become commodities what will it mean for all the people waiting for postmortem donations? I think the needs of people waiting for irreplaceable body parts (e.g. hearts, lungs, liver) should be considered before the needs of those waiting for a kidney.

I'm suspicious of the whole business of paying for kidneys. At its heart it is substituting a business ethic for a medical ethic. Historically that's been a bad deal for the ill. But I am particularly suspicious of the organ market advocates who focus exclusively on kidneys but not on kidney disease. When I see that these advocates have no energy to keep people from needing dialysis or a transplant; that there is no energy around improving the provision of dialysis; when these advocates have no interest in diminishing the overall burden of CKD5. I'm suspicious. Postrel has a very narrow interest around kidney transplants. I think she is seeing it as the only cure for dialysis.

For Postrel dialysis is seen as the disease. A fate worse than death, really no more than a slow death. And maybe someone like me might get use to it, or somehow be content with life on dialysis, no matter. To Postrel I Hate Dialysis makes perfect sense as a statement of fact; she's even gone to the point of convincing herself that Bill "Epoman" Halcomb IHD's founder shared her views, and that she knows what Halcomb believed in his heart. Postrel sees herself as having a moral duty to make sure anyone who wants a kidney transplant can get one, the important thing is to stay off dialysis. Transplant fetishist is not the best perspective with which to approach the question of paying donors for their organs. Postrel should have stopped at 3,700 words.

Hepatitis C Virus Transmission at an Outpatient Hemodialysis Unit—New York, 2001-2008

By Peter Laird, MD

As an incenter hemodialysis patient, reports on outbreaks of Hepatitis C always catch my eye.  It is a sad fact to note that transmission of Hepatitis C is completely preventable by simply following guidelines already in place.  I routinely watch techs and nurses fail to adhere to practices of hygiene that all of them would wish to have for themselves if the tables were turned upon them as it was for me.

I took a special interest in hand hygiene as a physician in part for my own self protection and that of my family as well.  Mainly, I did comply with hand washing for the best interest of my patients.  I had many patients comment that they had never seen a doc wash his hands after seeing them.  It was part of the reason why some sought me out as their doctor.  I spent years with rough and cracked skin surviving on the best skin creams that I could find.

The news from the CDC on a New York Hepatitis C outbreak is instructive on how far America has fallen from standard practices:

Inadequate cleaning and disinfection practices were observed during site visits in July and August 2008. A single bleach-soaked gauze pad was used to clean a patient's entire dialysis station, including dialysis machine surfaces and ancillary patient equipment (e.g., blood pressure cuff and shared computer monitor and keyboard). The bleach solution was prepared and stored improperly, and staff members did not allow sufficient contact time between surfaces and bleach. Visible blood remained on dialysis chairs, dialysis machine surfaces, and the surrounding floor between patient treatments. Moreover, direct care staff members failed to don gloves with every patient encounter, change gloves between patients, or perform hand hygiene after contact with patients and soiled surfaces. Supervisory staff members failed to address these breaches. Many of the direct care staff members were unaware of the hemodialysis unit's written infection control policies, including those pertaining to cleaning and disinfection. Investigators also noted the lack of a separate clean area for medication storage and preparation and short turnover periods between patient treatments.

It is my hope that publicity from such profound failures of care as found in the article above will prompt supervisors to actually supervise and correct those that they are charged to lead.  Until nephrologists take a more active role in administering proper patient and machine techniques in preventing transmission of Hepatitis C and other blood borne agents, the national shame of spreading Hepatitis C in American units will continue.  Once again, nephrologists are accountable.  If you own a unit or direct a unit, all failures of care are ultimately your responsibility.

When I was a lowly intern in a military program, I had the unusual experience of caring for a four star general who had six months earlier been the head over all military installations in North America. Fortunately, he was simply a normal person seeking the care we had to provide.  I struck up a conversation with this man and asked among other things, "Why do you fire the Colonel when private snuffy messes up?"  He answered quickly, "Because the Colonel is supposed to have the training program in place that will keep private snuffy from messing up."   It is time for nephrologists nationwide to put their foot down and use the lawful authority that they have as the individual person responsible for the prescription of dialysis and how it is carried out.  

The nephrologist in the article above is in danger of loosing his liscence because he failed to adhere to basic reporting guidelines as well as simple hygiene standards at his unit.  I am saddened to see a fellow physician in this predicament, but as a dialysis patient who has observed countless failures of care on a regular basis, it is time for all nephrologists to take heed that the employees that they are ulitmately responsible for are not doing the job that they are called to do.  The military overcomes these types of failures by private snuffy by firing the Colonel in charge as an example to the other Colonels in the same situation.  I would hope that this case becomes a sentinal event that gives all nephrologists in America a shot across the bow to get their own programs in order.  This is once again the responsibility of the supervising physcian.  It is time for American nephrologists to take control before more patients needlessly suffer from a single iatrogenic transmission of Hepatitis C.

Cherry Picking? I'm shocked.

By Bill Peckham

What's a person to make of the RenalWEB front page today? The DaVita press release about their special relationship with Natilie Cole is right above an American Society of Nephrology paper that dares to ask Is there "Cherry Picking" in the ESRD Program?. Do you really have to ask?

What's the problem with KDOQI?

By Bill Peckham

The KDOQI guidelines on dialysis adequacy are evidence based, but all the evidence is the result of current  practices i.e. three times a week dialysis; three times a week dialysis is current practice based on current reimbursement i.e. 156 treatments a year; 156 treatments a year is current reimbursement because units are able to achieve the KDOQI guidelines by running people short, fast and infrequently. Repeat feedback loop.

Does anyone else see a problem with this construct? Does it matter how people feel while dialyzing to achieve KDOQI minimums? Under the system that KDOQI shields, dialysis is violent and deadly. That should be enough to conclude that something is wrong with the whole construct.

What should be done to increase kidney donation?

By Bill Peckham

Dr. Kevin has a poll up asking: what should be done to increase organ donation? We're given three choices - get more people to sign their donor cards; pay for organs; loosen restrictions on altruistic stranger donors. Along with the post and poll on his own website, he also poses the question in audio form on Reach MD which seems to be an XM radio program. You have to go through a free registration process to listen but this looks like a worthwhile resource that is worth the effort to register. The Reach MD interface then allows you to phone in your comments. Looks fun, but I don't mind typing.

Transplant programs should accommodate altruistic stranger donations but I think it is important to remember that the goal should not be to increase the number of transplants. Rather the goal should be to increase the percent of people managing their CKD with transplant (as opposed to dialysis).

By redefining the goal in this way it's clear that it can be achieved in two ways: increase the number of transplants and/or getting transplants to last longer. This means that part of the discussion should be higher dose dialysis. An increased dialysis dose confers a graft survival advantage when it precedes kidney transplant. Increasing the dose of dialysis allows transplants to last as long as possible and it keeps people healthy enough to receive a transplant.

One reason transplant looks so good is because dialysis as it is typically delivered produces results that are so bad. We can start to fix this by implementing our request that the Congressional Kidney Caucus ask CMS to routinely reimburse for 183 treatments a year (instead of the current 156 which necessitates two days without dialysis). Working to improve kidney transplant should not give you a pass on working to improve dialysis. Dialysis and transplant are complimentary not competing modalities; the language of transplant advocacy should be complimentary and not competing as well.

Noncompliance in the Dialysis Unit: Who to Blame?

By Peter Laird, MD

It is interesting to see the various responses from those within the dialysis community to the call for optimal dialysis.  It is gratifying that many are supportive and active advocates for change to address America's poor CKD5 results, but there are others, and not a small group, that lay much of the blame for our poor results at the feet of noncompliant  patients. Some go so far as to see noncompliant patients as the major cause for poor outcomes in our system. Certainly, I have had my share of patients that fit the noncompliant category during my medical career and there are reports of noncompliance in dialysis units as high as 50%. Yet, what does the medical evidence tell us about dialysis noncompliance and its causes? An interesting study is instrumental to understand some of the underlying causes:

Psychosocial predictors of non-compliance in haemodialysis and peritoneal dialysis patients:

Patient age and smoking were statistically significant effects in the model predicting skipping treatment; current smoking (P=0.04) and younger age (P=0.008) were significantly associated with skipping treatments.

In addition, three psychosocial variables were significantly associated with shortening of dialysis treatments: little or no perceived control over future health, depression, and perceived effects of kidney disease on daily life. Patients who had shortened treatments were more likely to feel little or no control over their future health (P=0.007), to be depressed (P=0.01), and to be bothered by the restrictions that kidney disease placed on their daily lives (P=0.006).

A less recognized psychological condition that may also be widely prevalent in dialysis patients is Post Traumatic Stress Disorder. We usually consider this as a diagnosis of soldiers returning from combat. Yet an interesting study came to the following conclusion:

Posttraumatic Stress Disorder in Hemodialysis Patients

Conclusions: PTSD is common in HD patients, but little work has been done to explore the variables associated with PTSD. Data suggest that PTSD is under diagnosed and under treated in HD patients. Interventions should target these patients with the goal to improve well-being and quality of life.

Many are doing just that, improving their patients well being and quality of life through self care without waiting for CMS to declare what is best practice, they understand already.

Returning control to ESRD patients through self-care in-center hemodialysis.

In our self-care dialysis facility, there are 46-50 patients who live in an inner-city environment and who have a mortality rate of approximately 2% per year. [Editor's note: This annual mortality rate is far below the 23% nationwide rate.] They also have a transplantation rate that is above the norm.

NxStage Reports Sustained Reduction in Clinical Depressive Symptoms for Daily Home Hemodialysis Patients After One Year

"Depression is a serious, often undiagnosed problem for ESRD patients. The 12-month study results are extremely encouraging because they indicate that for eligible patients, switching to daily home hemodialysis may provide lasting relief of depression symptoms, especially for patients in greatest need -- those with moderate to severe depression," says Dr. Finkelstein. "In turn, addressing the problem of depression in patients could translate into less hospitalizations and improved morbidity and mortality, helping to alleviate the physical and emotional burden on patients and their families, as well as the financial burden on the healthcare system."

I must now ask a simple question, noncompliance in dialysis patients, who is to blame? The many who use noncompliance as the major excuse for our American survival debacle at 24% annually will certainly lay 100% of the blame on the patients themselves. Yet by giving dialysis patients the opportunity for self care whether with inner city in center self care patients or those at home on the NxStage, depression which is one of the central causative factors of noncompliance is nearly completely eliminated with improved patient control and self care.

Let me add one more element to this discussion before I draw my own private opinion on this matter. The fact that depression and PTSD are highly associated with hemodialysis to the extent that they have been associated makes me wonder whether noncompliance could be the result of our poor American approach to dialysis instead of noncompliance being the cause of our poor results as we hear so often. I believe firmly that exploring the definition of a simple word holds part of that answer - Iatrogenic:

An iatrogenic disorder is a condition that is caused by medical personnel or procedures or that develops through exposure to the environment of a health care facility.

The definition specifically states that any condition that is caused by exposure to the environment of a health care facility is iatrogenic, or at the fault of that health care provider. I will not list the many ways that hemodialysis is traumatic. I will not list the many ways that dialysis patients lose their independence in dialysis centers. I will not list the many ways that life on dialysis is restricted.

Lastly, I will not declare whether noncompliance is iatrogenic or not. But I would compel all American dialysis professionals to self evaluate usual dialysis care and compare that just to the two examples above as well as the many examples discussed on DSEN over the last several months. I have my own private opinion on the blame game played out by so many that oppose our efforts to initiate optimal dialysis by citing the American failure is due to noncompliant patients. Or is noncompliance simply another symptom of how far wrong usual care dialysis is in America? I will leave that to every individual to answer for themselves.

Renal Transplantation: Is it the Primary or Secondary Treatment for CKD-5?

By Peter Laird, MD

Until the time that we are able to regrow our kidneys in a petri dish, the debate will continue over allocation of a limited supply of donated living and deceased kidneys. Some castigate unfairly, in my opinion, those that have altruistically given their very flesh to family and stranger alike in an effort to stem the dance of death renal patients abide in. The gift of life of a living renal donation makes headline news on a regular basis. Complete strangers have stepped forward to give this gift of life to those in need. Yes, despite the many detractors of altruistic living donation, it does exist. The fact that we have even one stranger willing to give selflessly to another should always be applauded, especially by those that have so received.

Many continue to strive for a commercial system of financial reward in exchange for these extreme acts of altruism. Yet, in my mind, the debate on renal donations and various methods of increasing altruistic donations, financial compensation for vendor donations and deceased organ donations procured by opt out systems of presumed consent miss the central issue at hand, is kidney transplantation the primary treatment for CKD-5 or is it the secondary treatment option?

In the case of a patient that has a living related donor that gives this gift before the start of dialysis, many would argue reasonably that preemptive renal transplantation is the primary treatment option. Nevertheless, not all renal patients are transplant eligible. Issues of cardiovascular risk, cancer risk, obesity and co-morbid disease states eliminate thousands from the transplant list every year. Many choose not to place family or friends at jeopardy by asking for their healthy organs. I for one have a combination of relative medical risk and refusal to place my two willing donors at risk, my wife and my daughter who both came forward willing and eager to give me one of their healthy kidneys.

While I was exploring my own personal options, I had a great unease at accepting their gift if there was another viable option available to me. Certainly the diagnosis of malignant melanoma one month after I started dialysis settled the issue once and for all for me. The advent of cancer spreading out of control by aggressive immunosuppression augmented by my own willingness to bear my own disease without endangering my loved ones won out in my decision to pursue home, daily dialysis as my primary treatment option.

In the end, the issue of whether dialysis is the primary treatment option or renal transplant is turns out to be an individual decision based on many factors. Yet today, even though the overwhelming majority of patients will either choose to forgo transplant or not be eligible for transplant, the only consideration given publicity is that of renal transplant. We have about 1% of the hemodialysis census dialyzing in the comfort of their own home when other nations have up to one third taking advantage of this option.

For the majority of people with CKD-5 dialysis is their primary treatment option whether, home hemodialysis, home PD or incenter and they should be hopeful when reading the information that optimal dialysis has survival rates that rival living related transplant. These two CKD5 realities should place the primary treatment option of dialysis at the forefront of the discussion.

We continue to hear of those that die on the transplant waiting list. Yet, I have not seen one advocate of the various transplant procurement options come forth publicly in support of optimal dialysis even for those on the transplant list. Australia and other nations have a high transition rate from home hemodialysis to transplant with improved outcomes in their optimally dialysis patients awaiting their secondary treatment option of transplant.

Why are these very vocal advocates of renal transplantation so silent on the issue of optimal dialysis? I have my own private theories on why they remain silent publicly, but for those that understand that optimal dialysis is medically available but not socially promoted here in America, the tragedy that Belding Scribner sought to prevent overwhelms the benefit of all of our directed efforts for increasing renal transplantation when we consider those that could have survived if they had only had access to optimal dialysis.

Our short sighted efforts to focus all of our primary treatments in the renal transplantation option alone when the supply shall likely never meet the total demand from all who would wish a kidney, leads me to ask again, is renal transplantation a primary or secondary treatment option for the majority of American CKD-5 patients? If it is a secondary treatment option for the majority of our renal patients, then Dr. Scribner’s work was left unfinished. Perhaps answering this simple question first about dialysis and renal transplant will better focus our future efforts against this deadly condition.

NKF Off the Mark with End the Wait!

By Rich Berkowitz

The National Kidney Foundation has just launched a new initiative called End the Wait! It’s a worthwhile endeavor to expand the number of transplants. How could one disagree? As much as I think transplantation is a great cause and for many dialyzors the best form of renal replacement therapy, End the Wait's bang for the buck can only be limited.

On 6/30/08 there were 78,611 patients registered on the waiting list for a kidney transplant. According to a 2008 American Journal of Transplantation article abstract:

Growth in the number of active patients on the kidney transplant waiting list has slowed. Projections based on the most recent five-year data suggest the total waiting list will grow at a rate of 4,138 registrations per year, whereas the active waiting list will increase at less than one-sixth that rate, or 663 registrations per year.

As the waiting list grows, the number of transplants falls further behind the need (SRTR Graph), that’s for sure! Here is the number of transplants since 1997.

	Cadaver	Living	Total
1997	5084	3933	9017
1998	5339	4422	9761
1999	5386	4724	10110
2000	5489	5493	10982
2001	5528	6038	11566
2002	5636	6240	11878
2003	5753	6473	12226
2004	6325	6647	12972
2005	6700	6569	13269
2006	7180	6436	13616

Now compare that to the number of people on dialysis.

	In-Center Hemo	In-Center SelfHemo	HHD	CAPD	CCPD	Other PD	Uncertain	Total
1997	206,845	456	2,544	17,914	10,365	113	959	239,196
1998	224,547	355	2,484	15,941	10,541	96	1,033	254,997
1999	239,659	336	2,377	14,484	11,253	73	1,083	269,265
2000	254,735	268	2,180	13,274	11,894	67	1,095	283,513
2001	268,021	318	1,879	12,471	12,731	65	970	296,455
2002	280,095	273	1,756	11,590	13,692	73	930	308,409
2003	291,188	195	1,904	11,285	14,404	51	878	319,905
2004	302,325	187	2,059	10,896	14,752	43	880	331,142
2005	313,154	142	2,239	10,767	15,131	34	979	342,446
2006	325,188	111	2,455	10,415	15,667	32	886	354,754

Source: USRDS

The numbers of transplants are a small compared to the number on dialysis. How many more transplants will result from the NKF's additional spending? When you consider living donors are usually family or friends who don't need any additional motivation, the NKF's efforts can only really increase cadaver donations.

So where should the dollars go? It certainly doesn’t seem like transplantation is helping very many of those who have CKD5 and the prospects are not that much greater in the future, so maybe the dollars ought to go toward making dialysis the best it can be. Everybody that reads DSEN is aware that home dialysis modalities give dialyzors better outcomes and longer survival rates than incenter conventional hemodialysis. With the mortality rates as high as they are in the U.S., it’s unconscionable to ignore the modality used by the vast majority of CKD5 patients. Why does the NKF target their efforts just towards transplantation?

Perhaps promoting transplantation with the “Gift of Life” moniker is sexier than talking about dialysis; perhaps they’re marching to the beat of their corporate sponsors. Is the NKF's mission to assist those with severe CKD or serve the interests of its benefactors, and thereby insuring its own existence? Is this just one more reason why what the CKD community needs an organization which is free of corporate involvement?

Concerns of consequence about paying for kidney

By Bill Peckham

A new Sally Satel article was published three weeks ago; When Altruism Isn't Moral is again calling for compensation for living kidney donors. She categorizes arguments against her position as either arguments from corruption or arguments from consequence.

Arguments from consequence go like this: there is nothing intrinsically wrong with compensating donors, but it is not possible to design an incentive-based system without exploiting them. The worry is that economic straits could compel reluctant individuals to relinquish a kidney for the sole sake of enrichment.

This is indeed a troubling situation. Fortunately, it can be addressed with good policy. For example, a state government could provide compensation such as tax credits, tuition vouchers, a contribution to a tax-free retirement account, or lifelong health coverage. A non-cash reward won’t appeal to those in desperate need of financial help. What they want is quick cash, not delayed in-kind rewards. A months-long waiting period would dampen impulsivity and give more than ample time for donor education and careful medical and psychological screening. Finally, donors would receive quality follow-up care, something the current system does not ensure.

This is acknowledging that as a society we are not ready to support donation when we think the donor has made the wrong choice - for example donating a kidney to fund a deluxe Vegas weekend. But how motivating are delayed in-kind rewards? Are there studies to suggest that thousands of people would donate a kidney for a $10,000 addition to their IRA?

Satel doesn't look beyond implementation. How great an increase in organ donation should we expect? We should know the reward we're expecting for the risk. And there is risk. What happens if the whole business gets a reputation for being sordid and suspect when the news carries the inevitable stories of people monetizing their reward? What if the rate of organ donation goes down or stays the same? Would we then increase the reward? The problem is finding something that would both motivate thousands of people to donate a kidney AND be acceptable to the public. An organ market creates a dynamic where boundaries will be continually tested and there is a trade off between the program's integrity and its results.

I still have concerns of consequence.

The abstract dissonance of medical journals

By Bill Peckham

Peter's post is spot on, the one thing I would note is that having anything but an underpowered study is incredibly difficult. In the earlier paper published in JAMA based on the same study, the authors describe the process that enrolled people to participate:

Eligible patients were actively recruited from 10 hemodialysis units at 2 universities (University of Calgary and University of Alberta) in Alberta, Canada. The first patient was enrolled in August 2004 and the study was completed in December 2006, 6 months after the enrollment of the last participant. Eligible patients were at least 18 years old, were receiving in-center, self-care, or home conventional hemodialysis 3 times weekly, and were interested and willing to train for and commence nocturnal hemodialysis. Patients were excluded if they lacked the physical or mental capacity to train for nocturnal hemodialysis.

They were recruiting patients across 10 hospitals for two years. Getting people to participate in research is not easy. I think this recruitment problem deserves more discussion ... I'll leave that for another post. Back to the dissonance between the actual data in the paper Nocturnal hemodialysis does not improve overall measures of quality of life compared to conventional hemodialysis, and the abstract and its published title. The talk around the water cooler is that KI has instituted a new editorial process. Apparently it is now the editor's purview to rewrite the title and abstract as opposed to just the normal copy editing.

This is a revelation to me. I didn't know that a title and an abstract could be written not by the study's authors, but by civilian editors. Based on this I can't see much difference between a blog post and an abstract. As Peter says, these studies rely on the personal and professional integrity of the researchers but the abstract is treated differently. The abstract is just a blog post by the journal's editor. Under these circumstances I think it is incumbent on medical journals to attribute abstracts and attribute titles. These are not newspapers or general interest industry magazines where editors have wide latitude to market their publication.

Medical Journal papers, peer reviewed papers, should be the work of the researchers in its entirety. These things are full of footnotes; the authors of the marketing elements should be credited. How many people will never read beyond the title, let alone the abstract? Of the few who do read the whole paper will they have the background to come to their own conclusions as Peter did? Or will they read the paper through the lens of the spurious title and form unfounded opinions? Medical journals should not succumb to the ethics of business, at the expense of medicine. Until there is more clarity on the provenance of an abstract I am going to be hesitant to give them more weight then a blog post. At least blog posts are signed.

When Science becomes Propaganda

By Peter Laird, MD

The advancement of science hinges upon the tenants of truth and honesty engendered in the scientific method establishing the randomized controlled trial as the gold standard to eliminate bias, so keeping the results impartial from researchers personal preconceptions. In many ways, science depends implicitly upon the trust earned by those that practice these methods as much as the method itself. The veracity of a study is thus dependent upon the personal and professional integrity of the researchers themselves as well as those that publish their results. Today, with stiff competition among a myriad of medical journals, it is not surprising to see shades of truth stretched in an attempt to steal more readership. Yet, in the end, it must be avoided at all costs to maintain integrity and trust in that journal which is much more damaging in the long term than what the small temporal gain of a one time sensational headline may bring.

It is my opinion that ISN stepped over this fine line of scientific impartiality into journalistic sensationalism in their recently titled article: Nocturnal hemodialysis does not improve overall measures of quality of life compared to conventional hemodialysis. The title suggests a shocking reversal of numerous observational studies depicting exciting benefits of nocturnal dialysis. Yet, the authors themselves make no such claim in their concluding remarks:

There were limitations to this study and the results should be interpreted within the context of these limitations. First, the study was powered to detect changes in left ventricular mass, and thus statistical power was inadequate to detect clinically significant differences in several of the quality of life outcome measures. For example, we would have needed 342 patients per group to have 80% power to show a 0.03 unit change in EQ-5D index scores (the minimally clinically detectable difference). . .

In conclusion, our primary quality of life analysis did not demonstrate a statistically significant change between nocturnal hemodialysis and conventional hemodialysis. However, clinically important and statistically significant changes in some kidney-disease-specific measures were observed during the trial, and appeared durable over time. The magnitude of differences in EQ-5D index scores observed in secondary analyses (if confirmed in adequately powered randomized trials) would be of substantial clinical significance. These findings support the increased use of nocturnal hemodialysis in selected groups of patients.

In my opinion, the title suggests a completely discordant conclusion than the actual summation by the authors who stand in support of nocturnal dialysis based on their findings in this study that suggested, but did not prove due to too small a sample size, that some quality of life measures did in fact improve with nocturnal dialysis. Bill likewise commented on this study in an earlier post after the abstract was first released. I am saddened that the negative and unsupported title of this indeterminate and underpowered study may impart a lasting negative impression upon those that do not take the time to review all of the evidence presented by these authors.

In my opinion, the title is so contradictory to the evidence presented that I must question the credibility of the editorial staff who have the final authority over the title of an article as well as its content. For science to survive in the twenty first century, old fashioned values of impartiality and fidelity must be maintained and promoted actively. I am once again troubled by the negative and unsupported title of what was otherwise, in my opinion, a well researched and well written article. It is time to return to truthfulness in all parts of scientific reporting and avoid the sensational tabloid reporting methods reserved for torrid Hollywood gossip papers. In my opinion, it is not fitting to find examples of Hollywood sensationalism in medical journals devoted to finding the truth of important and lasting issues especially when the authors themselves support and found evidence suggesting substantial clinical significance in support of nocturnal dialysis. Simply reading the title of this article lends to a completely contrary opinion than that intended by the authors concluding remarks.

I would hope that ISN would take notice and correct this, at best, ambiguous title in favor of a more accurate first impression for this inconclusive and underpowered study that actually supports nocturnal dialysis by the findings of trends in improved quality of life indicators. The issues at hand demand honesty in all aspects of reporting and most importantly that which gives the first and most lasting impression, the title itself.

Medicare's cost/benefit analysis of lifetime immunosuppression coverage

By Bill Peckham

Medicare has made available a paper in its entirety by doctors Page and Woodward that appears in the winter 2008-2009 issue of Health Care Financing review. Cost of Lifetime Immunosuppression Coverage for Kidney Transplant Recipients (pdf link) builds on research done in 2004 by Yen et al. Cost-effectiveness of extending Medicare coverage of immunosuppressive medications to the life of a kidney transplant (pdf link).

As the Page, Woodward page states at the beginning Yen et al.:

used a Markov model to determine the cost effectiveness of lifetime immunosuppression coverage. They estimated the costs of graft failure to be $137,9302 per patient during the first year after failure. Then they combined this estimate with estimates of quality adjusted life year improvements and predicted a net societal savings of $136 million annually. While they included benefits in their analysis other than potential cost savings, the strongest case to be made for extending lifetime coverage to all transplant recipients would be to show a net cost savings to Medicare. For this reason, we examined this issue from only the perspective of Medicare’s cash flows.

Politically this makes the most sense. If you can make the case that aside from the positive societal value for lifetime immunosuppression coverage there is a cost savings to Medicare by making this coverage change then that would make it politically very easy to pass legislation granting lifetime immunosuppression coverage. And there is an easily understandable way that you could imagine Medicare saving money. Each year of immunosuppression coverage is cheaper than a year of dialysis, extending coverage would keep people off dialysis, Medicare saves money. That is a good elevator message.

However, Page & Woodward with what reads to be regret, shoot that idea down:

We found evidence to suggest that extending Medicare’s lifetime coverage of immunosuppression medications to all of the non-elderly, non-disabled population of kidney transplant recipients would have resulted in a significant additional cost to Medicare.

That's unambiguous. They did break out people in low economic demographics and show a potential savings in this group but under Medicare there isn't a way to introduce an economic need threshold, so they could only point back to the Yen et al. approach of including all societal cost/savings as the way forward. I think it does make sense to consider the entire societal cost of healthcare policy but I think Page & Woodward missed some potential Medicare savings.

Over the years of peer to peer online discussions I have "met" a lot of people and there is a group of people who self report that they are not seeking a transplant because of the three year immunosuppression coverage rule. I can't say how large this group is but my impression is that it is not insignificant. Often it is when a person would be accepting a living donation that they are most reluctant to put themselves into a position where they could not support the gift. My hypothesis would be that there is both a cohort who selects to not pursue a transplant and a cohort who selects to pursue a cadaveric transplant even though there is a potential for a living donor.

These two groups of patients should be investigated to determine their size and by extension the financial impact of switching them to transplant once lifetime immunosuppression coverage is available under Medicare.

It's true the guy did give her a kidney but everything else appears to be a total lie

By Bill Peckham

I've held off on commenting on the man wants his kidney back stories that have been widely discussed on not only CKD discussion boards and listservs but throughout the national media. It supposedly brings up questions of ethics and should we pay for organs. I don't think it does but I do know one thing: You should never think that you know what happened in a marriage if you've only heard the story from one of the spouses.

HDCN links to Dawnell Batista, wife at center of kidney case breakup finally tells her dramatic story published in the Daily News and sure enough it turns out the guy is a lying liar and a gigantic jerk. When the lying doctor "told Larry King his reason for divorce was “infidelity.” He didn’t say it was his own." In fact the wife has an incredibly sympathetic story and it is an indictment of the media that they took this liar and his Howard Stern lawyer at face value.

The one part of the story that the highly believable Daily News story missed is that the lying doctor also impacted people far removed from his self centered universe. This idea that your donor could come back years later and want your kidney will add another factor against in the calculus of accepting a kidney from a living donor. I am waiting for Larry King to have Dawnell on, as well as her corroborating friends so that the lying doctor can be properly held up to public ridicule and scorn.

While Larry is on the topic he should also have on his show someone from Donate Life (if it was up to me I'd call it Sustain Life, but whatever) to talk about living donation and why this one particular lying jerk shouldn't enter into anyone's personal calculus on whether to accept a kidney from a living donor.

Deceased Donor: Kidney Allocation Policy

By Anna Bennett

The facts are clear.  There are not enough kidneys for those who want to be transplanted and the "List" is overinflated.  See Bill's post Waiting for a Transplant - eligible v. ineligible.

In the past few years, there have been inroads in dialysis (NxStage and HDHH) and inroads in transplantation.  New immunosurpressives are doing amazingly well with low antigen match kidneys.  OPTN/ UNOS are in the process of changing the current kidney allocation criteria.  Back in September, OPTN/UNOS issued a request to the community for input. 

Bill posted about this request in Measuring Dialysis to fairly allocate kidneys for transplant .  He wrote about his concern with regard to qualifying dialysis yet not differentiating between the superior outcomes of High Dose Home Hemodialysis v. standard in center hemodialysis.

The Renal Support Network has posted their response to the proposed OTPN/UNOS Kidney Allocation Policy.  

In the final paragraphs of RSN's response, they have a wise, reasonable request:

Thousands of lives will be affected. So we ask that OPTN/UNOS allow ongoing conversation and input prior to a decision, that a final process be more simplified and readily comprehendible than that which is currently proposed and that a pilot program be considered. This will help understand the impact and allow for changes if the new system needs adjusting.

Watching the development of redefining the allocation process is an amazing window into healthcare reform.