Dialysis from the sharp end of the needle

New study links undiagnosed hypertension to CKD

By David Rosenbloom

Hypertension, abnormally high blood pressure, is called the “silent killer” for good reason. And I know this from personal experience. In May 2002 at age 57 I was diagnosed with CKD5 and placed in a  dialysis clinic within three weeks.  Over the preceding four months, my creatinine had climbed from 1.2 to 6.0, my GFR had dropped to 10-15% and my blood pressure rose to dangerously high levels.  

I had no known history of kidney or heart disease nor was I diabetic.  My blood pressure was always normal when taken at my annual physical. I ate a healthy diet, exercised several times a week and was not overweight. Yet probably sometime in my early 50s, I developed hypertension that went undetected. I also had no idea that I had lived my entire life to that point on one functioning kidney, the other being vestigial. Ultrasound tests taken at the time of my diagnosis, determined that startling fact.

I, unfortunately, am not alone. According to a recent study by the John Hopkins School of Medicine:

As many as 8 million adults in the United States who have undiagnosed or early-stage hypertension may also have kidney disease, putting them at higher risk for what may be preventable kidney failure.

The study, published online in the journal Hypertension, found that 27.5% of those with diagnosed hypertension also had kidney disease, while 13.4% with normal blood pressure have kidney disease. I clearly was in this group even though I had no outward symptoms.

Of people with early-stage hypertension, 17.3% had kidney disease, while of those who had undiagnosed hypertension, 22% had kidney disease. The research team at Johns Hopkins used data collected from the National Health and Nutrition Examination Survey (1999-2006), looking at records from nearly 18,000 participants for whom information on blood pressure and kidney function was available. This is the first time any study has estimated the prevalence of kidney disease among people with varying degrees of hypertension. Kidney disease rates were based on creatinine levels in the blood and proteins in the urine, and were estimated using guidelines from the National Kidney Foundation (NFK).

Experts have estimated that nearly a third of Americans have hypertension and have no knowledge of it nor are unaware that their blood pressure is in the danger zone. Consequently, they may not seek testing and treatment for hypertension or for kidney disease. Concurrently, an estimated 26 million adults in the U.S. have CKD, and the number is growing as obesity and diabetes reaches epidemic proportions. The conclusion is unmistakable. Hypertension and kidney disease go hand in hand.

“There’s likely a very large group who have kidney disease and don’t know about it,” said Deidra C. Crews, the study’s leader and a nephrology instructor at the Johns Hopkins University School of Medicine. “For people who have pre-hypertension, an alarm should go off in their physicians that says maybe this person should be tested for kidney disease. And patients should know that having even pre-hypertension is a big risk factor for kidney disease, and they may need to make lifestyle changes.”

In the study, Crews pointed out that there is some disagreement in the medical community over what levels of kidney function and urine protein should be used to diagnose kidney disease. Her study uses current guidelines from the NKF. Some nephrologists believe those guidelines may be too loose and that stricter guidelines would paint a truer—if smaller—picture of the number of people who suffer from kidney disease. My own nephrologist at the USC Keck School of Medicine has told me that even in patients without hypertension, kidney function declines about 1% per year after age 50.

NKF and many other kidney support organizations have mounted public education campaigns to make people aware of the prevalence of hypertension, it’s link to kidney disease and the need for everyone to be tested at regular intervals.  Like smoking, whose detrimental effects were first highlighted by the U.S. Surgeon General’s report over 50 years ago, the link between hypertension and CKD needs to become common knowledge.  Hopefully this Johns-Hopkins study will have the same effect.

Notes From Transplantation in the USA Part Three: Organ Trafficking Here and NOW

By Anna Bennett

This is Part Three  (parts one & two) of a three post series on Transplantation in the USA a program given in NYC on April 19th 2010 by the Kidney and Urology Foundation of America.

There is a HUGE disservice being done by the advocacy world to those in CKD5.  Why is organ donation always conflated with an Organ Market?  Paying an altruistic donor's medical bills is expected, it should be a given. Ensuring that a donor is not discriminated in future medical care, that too should be a given.  Missed work/recovery - well, that is a debate. I am ok with it, as long as it does not enrich the donor. The disservice is done by promoting travesties such as the Iranian Paid Donor System as optimal (as Dr. Tabarrock did).  It is that kind of example that just detracts from what can be done to help.  Citing a country with KNOWN human rights abuse removes all credibility and made Dr. Tabarrock an easy target for the final speaker of the evening, Dr. Nancy Scheper-Hughes, Ph.D., Chancellor’s Professor in Medical Anthropology, Head, Doctoral Program in Medical Anthropology, Critical Studies in Medicine, Science and the Body, University of California at Berkeley; Director, Organs Watch.

My first reaction, WOW! It was fortuitous that the she spoke right after Dr. Tabarrock, she easily refuted his citation of Iran being a good example of an Organ Market. She has actually had graduate students working in Iran, unbiased people who have seen the atrocities and abuse first hand. This woman brought it all into perspective for me. Her research is on Organ Trafficking. 

Dr. Scheper-Hughes is well versed in CKD and the unique entitlement that guarantees that we in the United States with CKD5 receive treatment. Entitlement is the key word here. If we paid into the system or are a child, we are guaranteed renal replacement in the form of dialysis or transplant and the government will pay for it. The Medicare ESRD Entitlement is a unique program, in this regard, Americans with CKD5 are very, very lucky.

Dr. Scheper-Hughes talked a bit about the history of the Medicare entitlement and the original Seattle "Life or Death" Committees. Dr. Scheper-Hughes spoke for a long time, and many in the audience were uncomfortable. It is tough to sit in the pristine Paley Center Screening Room, just off Fifth Ave in NYC, and be faced with the realities of Organ Trafficking. Those reception canapes paid for by big pharma don't sit too well when Dr. Scheper-Hughes points out that trafficking exists here in NYC - all over the USA actually - she gave us places and names, and slides of the traffickers.

Currently, one Trafficking Ring is flying in Moldovian Peasants to the USA to be paid donors.  The National Organ Transplant Act (NOTA) is the law that covers against paid donation has been on the books since 1984 (and then amended in 2008).  As of today there have been no prosecutions citing the act.  District attorneys are not enforcing it. Dr. Scheper-Hughes has been working with the FBI and various embassies, trying to stop this exploitative practice, and so far, nothing has come of it.  When she spoke to the Moldavian Embassy, their reply was (I am paraphrasing) "So, that's why so many were applying for visas".

I hope that we'll be hearing more from Dr. Scheper-Hughes, we need to be reminded that desperation can lead to exploitation.  There are better answers out there than buying a kidney on the organ black market.  Nephronline noted in their quote of the day (which, if memory serves, was said during the Q&A - when Dr. Scheper-Hughes was trying to see a solution to the desperation):

"Due to the huge shortage in available organs, a sense of desperation has set in, driving the current practice of organ trafficking. There are penalties for buying, selling and brokering the sale of organs in this country, but still it goes on, often with an attitude of 'don't ask, don't tell.' I believe that if the laws are not going to be followed, then the laws should change. First, though, a controlled study must take place, in an ethical manner, with a sample of volunteer organ donors being compensated appropriately."

—Nancy Scheper-Hughes, director of Organs Watch and an expert on organ smuggling at the Kidney & Urology Foundation of America transplant conference.

On a personal note: I want to thank Karol Franks (OKarol) over at IHD for posting about this program (that is how I found out about it). Karol is an AMAZING woman, and her dedication to those with CKD is a shining example for all of us. I want to thank KUFA (the Kidney and Urology Foundation of America) for putting on the program. I wish they did more for those 80% of people with CKD5 who are on dialysis with no transplant in their future. But I see that there is high drama in transplant. I'll admit, it is shocking to see the scars of the Brazilian mental patients who were kidney donors. What I'd like to see is some of that passion go into promoting HDHD. I'd like to see more examples like Bill, Peter and Harvey et al, showing that life does not stop with dialysis.

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)

Notes From Transplantation in the USA: Part Two Using Incentives in Organ Donation

By Anna Bennett

This is Part Two (part one) of a three post series on Transplantation in the USA a program given in NYC on April 19th 2010 by the Kidney and Urology Foundation of America.

Paying for organs has been discussed before on DSEN. I have firmly taken a stance that opposes creating an organ market here in the United States. That being said, the discussion is on the table and both sides have the mic.

The second speaker of the evening was Alex Tabarrock, Ph.D.: Bartley J. Madden Chair in Economics at the Mercatus Center and Associate Professor of Economics , George Mason University, Fairfax VA; Director of Research, The Independent Institute, Oakland, CA.

Dr. Tabarrock presented his studies showing that economic incentive is the way to cure the organ shortage. He even quoted Adam Smith (pretty safe bet for an economist). It was when Dr. Tabarrock started extolling the virtues of the Iranian system that he raised my ire. Seriously? He was using Iran as an example of a robust and functional organ market? He did. Really.

My favorite moment though was when he said that other medical/organ donations were already being compensated. His example: When you donate your body to science, they give you a free cremation after they are done. I almost laughed out loud on that one. What are these centers going to do? Ship the body parts back home? Of course the donated body would be cremated (hint Dr. Tabarrock, unclaimed bodies in NYC are cremated for free as well).

Obviously, I do not agree with Dr. Tabarock or the whole school of thought "Why can't I buy a kidney if I can afford it? It's the American way." There have been posts here on DSEN and all over the internet about the subject, it is polarizing and controversial. I cannot write unbiasedly about it. There seems to be two schools of thought, one of individual rights (Dr. Tabarrock's camp) and Society (my position). Dr. Tabarrock cited Israel and their compensation for deceased donors. I would agree that is a program worth watching closely. Deceased donors cannot be coerced or manipulated, they are not desperate.  He also cited the State of Pennsylvania creating a trust to compensate deceased donor families. He stated that the fund was established, but never used for fear of public backlash.

This is such a polarizing subject, and debate can easily devolve, and has.  My suggestion is that we watch and wait, and while we are doing that, let's fix the holes in the current system.  Because, before we create a whole new administrative and ethical nightmare with any form of compensation for donors (other than medical expenses) we have a lot of work to do. There is so much room for improvement in our system right now.  It is my opinion that Dr. Tabarrock's time, education and energy could be of use to the CKD community in a much more advantageous and practical way, rather than pick a morally gray area and try to grandstand upon it.

Notes From Transplantation in the USA: Part One Successes and Challenges

By Anna Bennett

The Kidney and Urology Foundation of America hosted a program last Monday: Transplantation in the USA: The Shortage of Available Organs and Public Health Policy:

There are over 100,000 people on the national transplant wait list, and most wait for kidneys. The organ shortage crisis and recent events surrounding the underground market for organs begs us to explore current practices in organ allocation, incentives for organ donation, and how health care policies evolve.

See NephrOnline coverage here.

It was my intention to attend this program and write a simple recap for DSEN. As I sat in the audience at the Paley Center for Media, all hope for an unbiased recap was lost. Instead, what I found was a diverse group of presenters who challenged my thoughts and opinions, and in two cases, reassured me that there are amazing professionals working in the field today. I am writing these as a series of posts.  This is the first: Successes and Challenges in Transplantation 2010.

After a warm welcome by Jonathan A. Winston, M.D., Program Chair and Moderator. There were greetings and mutual respect for an audience full of transplant professionals, transplant families and State Health Workers.

The first speaker was David J. Cohen, M.D. Professor of Clinical Medicine; Medical Director, Renal Transplantation, Columbia University Medical Center, New York, NY; Member, Board of Directors and Chair, Public Policy Committee, American Society of Transplantation.

Dr. Cohen's presentation Kidney Transplantation in the US 2010: Successes and Challenges, was direct, full of current statistics, and had plenty of suggestions to improve the current system. Dr. Cohen talked about problems in the system that laypeople usually never hear about. The disparity in practice between transplant centers. There is no uniform protocol, there is government mandated uniform reporting, but centers can pick and choose how aggressive they are when it comes to procedures. Do they push for extended criteria kidneys? Do they push for paired donation? Or do they strictly stick to the UNOS and living related donors? Dr Cohen really highlighted the under-tapped resource of paired donations, and he stressed that this is solely in the purview of the individual center. There is no national or regional system. In his center, they do the matching by hand and they assess the cases on an individual basis. My question, wouldn't a regional registry help? But Dr. Cohen notes that then, you would be asking people to wait.

Dr. Cohen also spoke about the reality of transplant being rationed medical care. The fact that only 20% of people in CKD5 are listed for a transplant. He posited that there were possibly 100,000 dialyzors (which would be about 25%) who could be listed, but for some reason are not. Dr. Cohen also stated that 30% of those on the UNOS list have significant levels of antibodies, extending their anticipated wait time. (My take: and thus, skewing the wait time average)

Dr. Cohen also used another phrase that I would like to point out: A transplant center's "Discard Rate": organs that go unused, for whatever reason. After listening to Dr. Cohen, seeing his slides and numbers, it's clear that there are gaping holes in the current system. These can be fixed, numbers can be brought up dramatically by simply fixing what already exists. With better organization, better communication and more informed patients.

He concluded on a hopeful note - by discussing some of the cutting edge protocols that are on the horizon for lowering PRA.

2010 is indeed a time of great success for renal transplant, and it is also a time of great challenge, because as long as inroads are made, the demand will rise for those who are eligible and desiring a kidney transplant.

KCC/KCP anticipate that the final rule will leave oral drugs out of the bundle

By Bill Peckham

I learned something else while reading through the advocacy letters to the VA - KCC/KCP does not think oral drugs are going to be a part of the final expanded bundle.

The Kidney Care Partners/Kidney Care Council joint letter to the VA (PDF link) contends that the Veteran's Administration, in proposing to set their dialysis reimbursement at Medicare's allowed rate, is wrong because their "Proposed Rule’s Overly Simplistic Analysis of Medicare’s Payment Policy Fails To Accurately Anticipate or Capture Effects of Future Changes" as evidenced by the fact that the "Proposed Rule Fails To Consider Medicare’s ESRD Prospective Payment System “Bundle”." The letter then lays out the pending changes (my emphasis):

Beginning in 2011, the MIPPA statute mandates that Medicare payment for ESRD will be based on a bundled payment system (i.e., one “bundled” payment to the ESRD facility per-patient per-treatment) that includes:

(i) items and services included in the composite rate as of 2010;

(ii) injectable biologicals used to treat anemia – erythropoiesis stimulating agents – and any oral form of such agents;

(iii) other injectable medications that are furnished to individuals for the treatment of ESRD and are paid for separately under Part B, and any oral equivalent of such medications; and

(iv) laboratory tests and other items and services furnished to beneficiaries for the treatment of ESRD (excluding vaccines).²⁰

According to CMS’ proposed rule issued September 29, 2009, the costs for these items would form the basis for an unadjusted base rate per patient tied to utilization data from the lowest of three prior years (2007, 2008 or 2009).²¹

Actually those items and " Oral Drugs without an Injectable Equivalent" (i.e. binders) form the basis of the unadjusted base rate per patient as published in the Federal Register (footnote ²¹ is to the proposed rule as published September 29, 2010).

Oral drug's absence from the KCC/KCP summary is hard to explain unless they believe the final rule will exclude binders, which would be a very good result.

The VA should use Medicare reimbursement as a starting point

By Bill Peckham

On Thursday RenalWEB posted letters from KCP, DPC and two Senators, to the Veteran's Administration [note: all links are PDFs] :

Public Relations Firm for Kidney Care Partners Releases Three Letters on Proposed Rule To Use Medicare Rates for VA Dialysis Services 

• Kidney Care Partners-Kidney Care Council joint letter to the VA
• Letter from Senate Veterans Affairs Committee Chair Sen. Daniel Akaka and Committee Member Sen. Mark Begich to the VA
• DPC letter to the Department of Veterans Affairs

Reading through the letters was my first exposure to the issue but I think KCC/KCP/DPC  have a point.

To simplify ... the VA has about 10,000 beneficiaries dialyzing in non VA dialysis units all across the country. The VA wants to pay the Medicare allowed rate for dialysis, currently the VA pays a whole range of rates but often the VA reimburses at a much higher rate than Medicare. The letters advocate against the VA using Medicare's allowed rates. I agree. I don't think Medicare's allowed charges, as such, should be used by non Medicare payers. Medicare has hundreds of thousands of beneficiaries dialyzing; they get, the rate they get, based on that buying power. Medicare will always have the lowest rates because they have the most beneficiaries (Medicaid is a special case).

The VA is trying to piggy back onto Medicare's buying power but reading the KCC/KCP letter, by law the VA is suppose to negotiate their rates separately, which seems reasonable. Like any insurer with 10,000 dialyzors the VA should be able to negotiate better dialysis rates than the LDOs' list price but without a thumb on the scale the VA shouldn't expect rates as low as what Medicare allows. The letters suggest that the VA create a "a viable national rate" not tied to Medicare. However, the letters don't offer a reason why the VA should not use Medicare's allowed rate as their starting point. Why not set the VA's dialysis reimbursement at 200% of the Medicare allowed rate? Or 300%? Medicare's patient/facility adjusted payment would be the logical starting point to set rates.

Medicare is the industry's most sophisticated payer. Medicare reimbursement rules try to match reimbursement to costs - there are case mix adjusters, geographic wage adjusters. But more importantly Medicare is on the verge of changing how they pay for dialysis, the final rule on the expanded bundle could come out any day. On January 1, 2011 the new payment method will go into effect (or start going into effect for providers who choose to phase into the new payment over the next three years), expanding the bundle is suppose to improve dialysis reimbursement's financial incentives, therefor why shouldn't we be advocating for all payers to use the new bundle?

I think paying separately for EPO resulted in the misuse of EPO. The dialysis industry should accept the expanded bundle as the new unit of service and change billing for all payers, in concert with Medicare's reimbursement change. The VA should be encouraged to use Medicare's methodology as a starting point in negotiating a fair rate.

Berwick likely to hear health care rationing questions from Republicans

By Bill Peckham

Donald Berwick looks to me to be the right person, at the right time, to run the Centers for Medicare and Medicaid Services (CMS). David covered the nomination announcement and he pulls together some recent press reports highlighting Berwick's impressive background, including quotes that suggest Berwick would be a strong advocate to improve healthcare provided through CMS. On Wednesday RenalWEB highlighted a quote from Berwick's press conference following his nomination:

Health care has no intrinsic value at all, none. Health does. Joy does. Peace does. . . The best health care is the very least health care we need to gain the long, full and joyous lives that we really want. The best hospital bed is empty, not full. The best CT scan is the one we don't need to take. The best doctor visit is the one we don't need to have.

That's a great mind set to bring to the job of running CMS.

However, yesterday Kaiser reported that Berwick May Face Difficult Confirmation In Senate; the Washington Post reports:

Democrats in the Senate said that, given Berwick's national stature and broad-based support, he would be easily confirmed under ordinary circumstances. But lingering partisan rancor over the health-care overhaul is almost certain to slow his confirmation, Senate sources in both parties said.

If only we were living under ordinary political circumstances.

Igor Volsky's reporting provides an idea of what might be the Republican focus during Berwick's confirmation process:

The Republican Policy Committee has already prepared a memo — which I’ve obtained — that links Berwick to the British health care system and presents him as someone who supports rationing and a government takeover of health care (Download the full memo HERE)

The Senate memo suggests that the Republican strategy will be to disparage the British National Health System (NHS) and by extension, Berwick.

The gist of the memo is that Berwick consulted with NHS and has said nice things about elements of the British health system (DSEN has been skeptical, the Renal Tsar helpfully looked at NICE through the CKD lens). Most of the Republican talking points seem designed to take issue with Berwick's characterization of NHS i.e. Berwick said NHS does a pretty good job, while the memo notes news reports with examples of people who didn't like an NHS decision or practice.

The memo makes clear that the Republican goal is to create the impression, in the minds of voters, of a potential "Medicare Administrator who explicitly advocates for rationing as indicative of Democrats’ government takeover of health care". The Republicans intend to use Berwick's confirmation to pursue political ends. That is a disservice.

Medicare is an important and popular government agency that needs to be well run. CMS isn't the Veterans Administration (an example of an American version of NHS); NHS has limited relevance to the job Berwick is being asked to do - lead CMS. And CMS needs a leader. Having a fully confirmed Administer makes a difference. CMS has not had a fully vested leader for four years. CMS has made do with an acting administrator but four years is too long for this important agency to be hobbled administratively.

I hope voters will ignore the smears, should they come, and instead engage with the issues faced by Medicare and Medicaid on a deeper, more sophisticated level. Berwick has thought deeply about health care including end of life care. As a country we need to talk about end of life care. We need to discuss the care we expect Medicare to provide and Berwick is an excellent person to lead that discussion. There is nothing to fear in this process.

Berwick is the right person for the job. Republicans should not obstruct his nomination through a divisive confirmation process. Mischaracterizing the choices the next CMS Administer faces, suggesting that the intention or that there is even the possibility to create death panels, is asinine and will harm Berwick's ability to lead CMS to achieve better health outcomes and ultimately lead CMS to provide their beneficiaries with long lives of health, joy and peace.

Is Dialysis Medicine’s Least Loved Treatment?

By Peter Laird, MD

A recent article featured on Gary Peterson’s RenalWeb, Stakes in kidneys from The Economist, is a throwback to the days of unceremonious insolence towards dialysis treatments seen before the accolades of optimal dialysis became the standard of medical reporting in the last two years. Stakes in kidneys:

The battle over one of medicine’s fastest-growing and least loved markets:
DIALYSIS—the use of machinery to make up for malfunctioning kidneys—is among medicine’s least loved treatments, both to endure and to administer. Patients have to be hooked to machines for hours at a time every few days. Those providing care often find it difficult, too: as many as a fifth of their patients die each year, many of them after choosing to stop their treatment. But it is also a fast-growing and lucrative market, and one that provides valuable lessons about making health care affordable.

Yet, the reality of the reason why America has slipped into a dialysis free fall with poor outcomes and skyrocketing costs is clearly evident in the text of this short article that focuses on why America is the largest dialysis market in the world, it is simply a lucrative business.

Some 2m people receive regular dialysis to clean their blood of impurities that build up as a result of kidney failure. About a quarter of them are in America, which has one of the highest rates of dialysis in the world. This is less because Americans are especially unhealthy (although high rates of obesity and diabetes do play a role) and more because American health policy is to provide dialysis to anyone who needs it, regardless of their ability to pay or their chances of surviving much more than a few months. It is also the world’s most lucrative dialysis market, with the government spending $24 billion a year, or $71,000 a year per patient, on dialysis, and private insurers paying yet more.

Thus, the business of dialysis sealed the fate of the American dialysis patient that became a commodity in the global dialysis economy instead of a cherished patient given the opportunity to live life in what was previously a universally fatal condition.  I am grateful for the nearly four years of additional life given to me by a simple machine since I started on dialysis in early 2007. In that time I have had the joy of seeing my son enter and excel in college and a new grand child enter into this world.

The failed American model will continue as long as biased accounts of American dialysis permeate the medical literature such as this prejudiced account.  Dialysis is perhaps the greatest gift of life ever developed by medical science.  It is time that the truth of this lifesaving advancement shine forth in the appreciation that I and millions of people the world over share for another chance to live beyond our foreshortened lives that we never would have had without the miracle of modern dialysis.  The only sadness about dialysis is how America's dialysis business model has produced untold wealth for dialysis profiteers yet at the same time failing to keep pace with the advances that are standard care in all of the other developed nations.  The way we think and talk about this treatment influences how it is delivered here in America in a less than optimal way, but at maximum profit.

Patients’ Reviews Missing from Drug Safety Studies

By David L. Rosenbloom

I am always amazed at the inbred arrogance of the medical profession. For such a large industry, and it is an industry, to ignore its customer base is not just stupid, it’s often fatal. Unfortunately with medicine, it’s the customer who suffers the most, not the industry.

Smart, successful companies test market new products before widely introducing them to consumers. So do pharmaceutical manufacturers. They are required by federal law to perform clinical trials before gaining FDA approval to bring them to market.

But according to a study published in the NEJM by Ethan Basch, MD, an oncologist at Memorial Sloan-Kettering Cancer Center in Manhattan who specializes in treating patients with prostate cancer:

A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’s “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug.

In an interview in the New York Times, Dr. Basch says that direct reports from patients are rarely in clinical trials:

If patients’ comments are sought at all, they are usually filtered through doctors and nurses, who write their own impressions of what the patients are feeling… doctors and nurses “systematically downgrade the severity of patients’ symptoms” and sometimes miss side effects altogether. One result is “preventable adverse events” — for instance, suicidal thoughts in young people taking antidepressants, or severe constipation in people taking a drug for irritable bowel syndrome, both of which might have been detected earlier if symptoms had been systematically tracked.

Dr. Basch first became interested in under-reported adverse effects when he attended a presentation on a new cancer drug. Fatigue was not found to be much of a problem, but other doctors in the audience said their patients had suffered terribly from it while on the drug, so much so that some had quit taking it. Somehow, the study had completely missed that finding. Intrigued, he began to study people receiving chemotherapy, and to compare symptom reports by patients with those from doctors and nurses. The differences were striking. For every problem — fatigue, nausea, appetite loss, vomiting, diarrhea, constipation — patients reported it earlier and more often than did doctors and nurses.

The tendency to downgrade symptoms reflects a number of medical prejudices and practices fraught with faulty judgment. They included unscientific comparisons of patients at different stages of the same disease, or wishful thinking by doctors, who may think that a certain drug will help patients and don’t want to take them off it. Or fear of malpractice litigation if one too carefully charts a patient’s adverse reactions to a drug the doctor has prescribed. Sometimes such information is lost when doctors and patients get distracted by test results and treatment plans and forget to discuss symptoms.

Not to mention the obvious - mistakes and distortions in reporting symptoms which are compounded when one researcher collects the information, another retrieves it from the chart and enters it into the study record, and still others evaluate it. From the Times:

Patients may also tell doctors one thing and then write another in their own reports,” Dr. Basch said; most say their written accounts are closer to reality.

Medwatch, is a web-based system devised by the FDA that lets doctors and patients report problems they think are adverse reactions from drugs already on the market. From the Times:

But it’s a passive system that waits for reports instead of actively surveying patients. Many people don’t know about it, and it has failed to catch some important adverse events”, Dr. Basch said.

A better approach, he says, “would be to have large numbers of patients filling out questionnaires before and after drugs are marketed ...

If patients had been asked to report their symptoms while the drug was still being tested,” he added, problems might have been detected before it was even approved.

Gathering the patients’ information would require some additional cost during clinical trials, but not much compared with the overall cost of drug development and probably save money by heading off potentially expensive problems.

Dr. Basch reported he was surprised to find drug companies enthusiastic about his research.

From the NEJM paper:

In fact, patient self reporting as a data-collection method was recently embraced by the FDA in its “Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims,” in which “patient-reported outcomes” — a term that broadly refers to any data directly reported by patients without interpretation by someone else — are characterized as the standard method for assessing subjective phenomena that are best described by the patient, such as symptoms.

However, the scope of the FDA guidance is limited to the collection of data to support labeling “claims” (e.g., claims of efficacy or safety benefit based on comparative data); it does not address the use of patient-reported outcomes for adverse-event screening.

Not satisfied with these guidelines, Dr. Basch and his colleagues have developed an initiative to introduce patient-reported outcomes as part of a National Cancer Institute “standard component of adverse event monitoring” in NCI-sponsored trials. He strongly believes that patients are more than willing to share their experiences with adverse drug reactions, and that modern, web-based sampling technology could make that very easy to accomplish. It is what many companies and organizations already do via email surveys to clients, customers and members.

I know from personal experience about severe drug “side effects.” My biological family often reacts negatively and swiftly to prescription medications. As a dialyzor for 6+ years and now a post-kidney transplantee, I react negatively to about 30% of the drugs doctor’s prescribe for me, often within minutes. My computer-generated printout of drugs and supplements, which I present to every new doctor I visit, has a rather long list of commonly prescribed drugs to which I am allergic, like penicillin and its derivatives, and many common blood pressure meds and immunosuppressants. It often surprises them, and they invariably say in a dismissive tone, “Oh, I’ve never had a patient complain about severe reactions with this drug. After all, it’s widely used and very effective.”

Then I tell them the story of my 49-year-old brother’s Prozac-induced suicide in 1990 after being on the drug less than a week and of the large legal settlement Eli Lilly paid my sister-in-law for the wrongful-death suit she brought against them. It has a rather dramatic and sobering impact on their initial thought that I must be exaggerating about severe drug reactions. After that, they become very attentive to what I have to say.

It’s a tragic outcome of a manufacture under-reporting adverse effects in clinical trials. Prozac was the first of the modern psychotropic, wonder drugs. In most cases, it has helped people. But with a small percentage, they become suicidal, even if they have never exhibited such behavior before. My brother was such as case. Eli Lilly has since automatically informed doctor’s prescribing Prozac of the need to closely monitor patients for signs of suicidal depression in the first week to ten days of taking the drug.

Perhaps if we adopt Dr. Basch’s recommendations and really start listening to patients - accurately recording their drug reactions during those trails - everyone will benefit, and I won’t have to be on “high alert” every time I take a new drug.

The Good Dialysis Index

By Bill Peckham

Dr. Agar has posted his Good Dialysis Index, which he presented during the morning session of Comprehensive Course in Hemodialysis on the Saturday of the Annual Dialysis Conference weekend last month in Seattle.

Answering yes to one of the 20 questions earns you a point; anything above 16 indicates Good Dialysis. This simplicity is a design feature. The idea is to create something usable, that matches clinical experience. 

The Good Dialysis Index is a survey across four categories of questions: Patient Directed; Process Directed; Laboratory Directed; Chart Directed. Agar acknowledges that any snap shot of dialysis quality will give an incomplete picture, but over time a good GDI score will mean more than a good Kt/V.