HemoDoc, From Doctor to Patient

Are DaVita Patients among the Village of the Damned?

By Peter Laird, MD

The Denver based magazine, 5280 published an expose on the CEO of DaVita, Kent Thiry called The Strangest Show on Earth. Luc Hatlestad spent several weeks embedded in the DaVita operation following the daily endeavors of Kent Thiry including his very controversial style of leadership at DaVita employee meetings.  He promotes the theme of the three musketeers in all of these meetings often entering in costumes in character shouting "all for one, one for all."

However, the shocking detail that patients fail to understand is that the DaVita "village" is only that of the employees and not the patients. The high fives create a culture of loyalty not to patients, but to the company. Kent Thiry has openly admitted that the business of DaVita is not about the patients. Many critics of DaVita understand these dynamics well:

DaVita has wider health care ambitions: patients wary

"I just don't see this ending well," said Bill Peckham, a Seattle dialysis patient who writes a blog popular in the kidney care field. "You're substituting business ethics for medical ethics, and I think that's a bad deal," said Peckham, who gets his dialysis from a nonprofit center.

Though the government is emphasizing its quality mandates in the ACO contracts it has issued so far, Peckham said the model encourages withholding of care to save money and create profit-sharing. DaVita faces legal challenges to its use of the critical dialysis drug Epogen, and to its business relationships with doctors.

Thiry calls himself "The Mayor," and employees "citizens" of the DaVita "Village," Peckham noted.

"Where does that leave the patients? We're the 'crop.' We're the 'ore' in the mines. That's not a fun place to be if you're the person who needs dialysis," he said.

Ironically, I am currently a DaVita patient on home hemodialysis after my DSI unit was taken over by DaVita. Already, there are major changes I have observed that leave me less than confident that my health care in this company is about me. I am tired of getting one roll of tape for an entire month of dialysis where I can easily use that one roll in a single session. I now must send in my clinic notes by fax on a daily basis once again, not for clinical oversight, but for billing purposes even though Kaiser only pays DaVita on a monthly basis.

DaVita further is in charge of my monthly labs. With their history of putting profits ahead of patient safety as evidenced by their alleged blind allegiance to increasing EPO dosages to maximize profits witnessed in recent legal actions against DaVita, I lack the personal confidence in DaVita to plaee my interests ahead of their own. After all, I am not part of their village, that belongs only to the employees.

One statistic that is difficult to document is the allegations of increased involuntary patient dismissals. For these unfortunate patients, speaking up against failings of the DaVita system in their own personal care often ends with an involuntary dismissal leaving some patients with no alternative units for their care. For these patients, life becomes a day by day struggle where the local emergency room is their only option. Unfortunately, most emergency units will only dialyze the patient if they are in immediate danger.  High potassium levels do not always earn them an intermittent dialysis session. Some ER doctors will give these patients a dose of Kayexolate to lower the potassium levels and send them home.  For these DaVita patients, an involuntary dismissal is tantamount to a death sentence leaving them truly in the village of the damned.

The Strangest Show on Earth

Some former patients have even accused DaVita of blackballing them to other non-DaVita dialysis clinics, which, if true, would be another federal privacy violation. “DaVita is number one in dumping patients,” says Arlene Mullin, an advocate in Battleground, Washington, who shared dozens of emails with me detailing alleged abuses of the patients she represents. She contends that DaVita clinics operate with virtually no accountability or oversight. “I’ve gotten notarized statements from patients so I can advocate for them, and neither ESRD Networks nor DaVita has recognized any of them. [ESRD Networks and the government] have no authority over these clinics. None.” Mullin claims that DaVita’s insider connections to CMS and ESRD Networks allow clinics to get tipped off about what should be surprise inspections. (She says this also happens at non-DaVita clinics.) The patient advocates I spoke with uniformly believe that ESRD Networks and CMS respond to grievances by stonewalling, burying them in bureaucracy, or ignoring them altogether. “Of all the patients I’ve helped to file complaints, in 100 percent of the cases, ESRD Networks has sided with the dialysis companies,” Mullin says. “Medicare has allowed this industry to oversee itself.”

Bill Peckham, a longtime dialysis patient turned activist blogger, goes a step further, saying the “all for one” DaVita Village concept simply doesn’t include patients. He likens the company to a village that mines coal. “We patients don’t have the voice of a citizenry; we’re just the coal.”

For anyone that understands that these kind of intermittent treatments place patients at high risk of death and other adverse outcomes, these patients truly are living in the village of the damned condemned to uncertainty, suffering and rapid decline in their health often imposing a sure death sentence. Sadly, DaVita is often the only dialysis unit in isolated communities leaving patients at the mercy of the DaVita business practices which by their own admission are not about the patients.

I suspect that my time at DaVita will be short lived and I am currently exploring other options for my long term care in the Pacific northwest area.  I have heard directly from DaVita employees who are uncomfortable with DaVita business practices and requirements. For a dialysis company to promote the village concept for their employees only but not for their patients leaves me with the same question that Bill Peckham has posed, where does that leave the patients?  For some of those that dared to stand up to DaVita and speak out, the involuntary dismissals that they earned truly leaves them in the village of the damned.

DaVita Faces Opposition to Eastern Maine Medical Center Dialysis Sale

By Peter Laird, MD

DaVita and Eastern Maine Medical Center (EMMC) are seeking permission from the Maine regulatory agencies to approve a pending sale of three dialysis centers now run and owned by EMMC. However, they are facing opposition from the nurses unions due to concerns about alleged quality of care issues with DaVita which is currently under investigation by several agencies. The opposing sides met in a public hearing to decide the fate of this sale:

 

The allegations that DaVita places profits ahead of patient care is not helped by their own CEO, Kent Thiry, who has publicly stated that DaVita is not about the patients, it is about the company and their teammates. (go to 109 minutes and 35 seconds on the following video) Since I just became a DaVita patient myself after my DSI unit was bought out over a year ago by DaVita, my impression is that billing and financial accountability are at the heart of their corporate concern for my treatments.  

 

DaVita is so obsessed with billing for my home dialysis sessions that they have given me a fax machine so that my nurse can do daily reports to the DaVita corporate headquarters even though Kaiser pays only on a monthly basis. Other than daily billing and the burden of sending off a daily fax, I see absolutely no new benefits from DaVita on my behalf. Instead, I am locked into a relationship now with big brother DaVita reviewing my treatments day by day and their mayor securing each and every billable moment. What part of DaVita's village do I now belong and if it is one for all all for one for the mayor and the teammate citizens, who then is my advocate in this huge corporate megalith?

The DaVita village and its citizens who are "all for one and one for all" don't have any place at all for the patient in their company philosophy. This is the chief failing of DaVita in my opinion, as Bill Peckham pointed out recently, if they are the village and Kent Thiry is the mayor, what does that make us patients?  I would hope that the patients serviced today at EMMC take the opportunity to learn more about DaVita and their aggressive business tactics that in my opinion come at the expense of the patient. Certainly, for anyone that listens to Kent Thiry state clearly that it is not about the patients, you must wonder what it is that motivates Kent and DaVita if it is not about the patient?

Sadly, there is little that the nurses unions or patients can do to prevent the sale of the EMMC dialysis units to DaVita. This is even more imperative since EMMC is the sole dialysis provider for Bangor Maine and the huge rural area it services. Any patinet who is involuntarily discharged from DaVita will have no other alternative treatment options other than emergency room services which for most patients is an inevitable death sentence. The people of Maine have the evidence before them to reject DaVita and seek alternative assistance for their dialysis needs. Whether the government agencies involved will question the integrity of this corporation and what I consider empty DaVita promises will only be known in its own time.

My thoughts and prayers go out to the people of Maine who include my own close relatives who live in this area and could in the future depend on the outcome of these decisions.

Pushing Organ Procurement Ethics Over the Slippery Slope

By Peter Laird, MD

The dead donor rule serves organ donors protecting those that can no longer speak for themselves. Tragic cases of death by organ donation are not talked about especially in the renal community yet they are documented and continue to occur in large part due to the lack of uniform brain death criteria throughout the US. Though fortunately rare in occurrence, anyone that has seen the NBC news report on the Zack Dunlap case should seek legislation assuring that no one would ever die as a result of death by organ donation. (here)

Unfortunately, coupled with paradoxical outrage at a Wall Street Journal article documenting the rare cases of death by organ donation, medical ethicists recently turned the discussion to procuring organs prior to the death of the donor. Although there were some ethicists who spoke against this newly proposed donation policy, many supported this new medical ethics paradigm.

The Case for Kidney Donation Before End-of-Life Care

Donation after cardiac death (DCD) is associated with many problems, including ischemic injury, high rates of delayed allograft function, and frequent organ discard. Furthermore, many potential DCD donors fail to progress to asystole in a manner that would enable safe organ transplantation and no organs are recovered. DCD protocols are based upon the principle that the donor must be declared dead prior to organ recovery. A new protocol is proposed whereby after a donor family agrees to withdrawal of life-sustaining treatments, premortem nephrectomy is performed in advance of end-of-life management. Since nephrectomy should not cause the donor's death, this approach satisfies the dead donor rule. The donor family's wishes are best met by organ donation, successful outcomes for the recipients, and a dignified death for the deceased. This proposal improves the likelihood of achieving these objectives.

As a renal disease sufferer, I initially considered pre-emptive renal transplant with donation from my wife. However, after considering both my prior history of cancer and risk of cancer recurrence after renal transplant and the risks entailed for my wife, I declined to pursue that option and then focused on optimal dialysis considerations. After all, renal disease is my disease and my responsibility. I do regret the loss of the kidneys that God granted to me, but I do not believe I have any right to another persons kidney whether dead or alive. It is a gift, it is not a right of any person with renal disease. 

It appears to me that in many ways, the renal community has transformed renal donation into a right over the last two decades. Presumed consent at its heart gives ownership of vital organs by the state for all those that don't opt out of this system utilized in Spain and other nations. While I value the gift of organ donation, I still cherish my civil liberties and I would hope that the demand for renal donation would never preclude our right to liberty and self determination. Once again, it is my disease, not someone else who is a complete stranger to me who has their own right to life, liberty and the pursuit of happiness.  In many ways, I personally would much rather die from my renal disease than see my renal disease used as a means of of encroaching another man's civil liberties.

I fear that I am in the minority opinion among my friends and colleagues in the renal community. It appears that just about any means of increasing renal donation no matter what the ethical implications of those policies and procedures is gladly welcomed by the renal community at large. Presumed consent, abandonment of the dead donor rule, donation by cardiac death and now kidney donation before end of life care infringe civil liberties for society in general and push the organ procurement ethical framework over the slippery slope endangering individual societal rights.

While I am sure that I will likely be in the minority opinion on this issue among the renal community, I must still question whether there are limits we should not cross in providing all available ethical renal donations? Changing the definition of what is ethical is a dangerous slippery slope that poses risks to society at large. Should we not who are most at risk in this society from our own renal disease support the protection of others who can no longer speak for themselves in their own tragic circumstances and forgo our greed for their organs by ever changing medical ethics?

American society decades ago saw the dangers of euthanizing anencephalic children and harvesting their organs recognizing the sanctity of person-hood in these children doomed to a sure death shortly after birth. I suspect our current modern society will re-evaluate that decision as well one day. I don't see these changes in our medical ethics as a positive change in any manner. I believe it shows a callous disregard of our human condition and respect and dignity for the individual and life in general.

We in the renal community must consider that same callous disregard for individual lives could in the end be the same sort of justification given to terminate treatment of those with renal disease as well. We are on the high price, low benefit scale according to many medical ethicists with some questioning how we perform dialysis in America. (here)  The renal community needs to be very careful what we ask for as there are always consequences of seemingly small decisions. 

Donation prior to death should never be the standard for organ procurement. I would hope that the renal community would understand this better than the general population since it was the respect for individual life that spurred the 1973 ESRD program funding in the first place. Losing this fundamental ethical paradigm could have untoward outcomes on continued ESRD funding in the future. The demand for kidneys today should not subvert the ethical foundations that secure our future especially in a time of limited resources.

I personally call upon the renal community to stand up and firmly disengage from the pursuit of renal donors at any cost through alteration of long held ethical paradigms. I would hope that the renal community will instead reaffirm the dead donor rule and set limits on the ethics of organ procurement. Respect for all life begins by recognizing the importance of the individual no matter what circumstances they encounter. Is that not the story of the ESRD program in 1973? If we won't stand up for those at risk of death from trauma and other illnesses, who will stand up for us in our time of need that the future shall surely bring.

Should America Measure Dialysis Outcomes Based on Employment Rates?

By Peter Laird, MD

The American dialysis experience especially in the last three decades is at great variance to the outcomes of all of the other industrialized nations with large dialysis programs.  Many inside the US dialysis industry squarely place the blame on the patients themselves citing higher levels of diabetes, HTN and elderly patients than other nations. However, extensive studies over the last two decades by DOPPS and other organizations came to a different conclusion. While there are differences in patient demographics, these alone do not entirely explain the differences in outcomes and higher mortality rates. DOPPS concluded that practice variations of vascular access, treatment times and ultrafiltration rates better explained many of these differences in outcomes.

International Hemodialysis Patient Outcomes Comparisons Revisted: The Role of Practice Patterns and Other Factors

Survival among HD patients in Japan, Europe, and the United States: Data from DOPPS I (1997 through 2001). *Cox proportional hazards model adjusted for age, male gender, black race, coronary artery disease, congestive heart failure, other cardiac disease, left ventricular hypertrophy, cardiomegaly by x-ray, hypertension, cardiovascular disease, peripheral vascular disease, diabetes, lung disease, dyspnea, smoking, cancer, HIV/AIDS, gastrointestinal bleed, peptic ulcer disease, hepatitis B, hepatitis C, neurologic disorder, psychiatric disease, recurrent cellulitis or gangrene, and vision problems. **P < 0.001.

Saran et al found a direct correlation between increased treatment time and a 7% reduction in mortality with every thirty minutes of addition dialysis per session:

Longer treatment time and slower ultrafiltration in hemodialysis: associations with reduced mortality in the DOPPS.

Figure 2.

Longer treatment time (TT) and slower ultrafiltration rate (UFR) are considered advantageous for hemodialysis (HD) patients. The study included 22,000 HD patients from seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Logistic regression was used to study predictors of TT > 240 min and UFR > 10 ml/h/kg bodyweight. Cox regression was used for survival analyses. Statistical adjustments were made for patient demographics, comorbidities, dose of dialysis (Kt/V), and body size. Europe and Japan had significantly longer (P < 0.0001) average TT than the US (232 and 244 min vs 211 in DOPPS I; 235 and 240 min vs 221 in DOPPS II). Kt/V increased concomitantly with TT in all three regions with the largest absolute difference observed in Japan. TT > 240 min was independently associated with significantly lower relative risk (RR) of mortality (RR = 0.81; P = 0.0005). Every 30 min longer on HD was associated with a 7% lower RR of mortality (RR = 0.93; P < 0.0001). The RR reduction with longer TT was greatest in Japan. A synergistic interaction occurred between Kt/V and TT (P = 0.007) toward mortality reduction. UFR > 10 ml/h/kg was associated with higher odds of intradialytic hypotension (odds ratio = 1.30; P = 0.045) and a higher risk of mortality (RR = 1.09; P = 0.02). Longer TT and higher Kt/V were independently as well as synergistically associated with lower mortality. Rapid UFR during HD was also associated with higher mortality risk. These results warrant a randomized clinical trial of longer dialysis sessions in thrice-weekly HD.

For over forty years, Belding Scribner and many of the pioneers of dialysis in America advocated changing  our practice patterns as the central focus of change in the US dialysis industry. While I applaud the efforts of Gary Peterson, Rich Berkowitz and Denise Eilers in their lobbying efforts to educate congress on the dysfunctional US renal system, focusing on employment as the most important measure of dialysis outcomes may have unintended consequences that could paradoxically damage the ESRD program and its funding.

On the other hand, the ESRD demographics are important indicators of the total rehabilitation potential in this population. In the 1960's and early 1970's, with limited resources, diabetic patients and elderly patients were excluded from treatment. In addition, those that were granted access to dialysis treatment were expected to learn and preform self care dialysis at home much more so than in-center treatments once again due to limited resources. This highly selected ESRD population had a very high rehabilitation potential and most were able to continue working. Many such as Nancy Spaeth raised a family and worked as a nurse and continue to remain very active in dialysis education and advocacy today after being diagnosed with CKD in 1959. 

Today, approximately 44% of the incident and prevalent US dialysis patients suffer from diabetes.
Diabetes affects the cardiovascular system from the small to large blood vessels and this is the primary mechanism of disabling conditions leading to strokes, heart attacks, blindness, amputations, chronic skin ulcers and infections as well as numbness and tingling from peripheral neuropathies. It is a systemic disease where early measures of damage to the kidney correlate with a higher risk of stroke and heart attack. Many consider microalbuminuria a direct marker of cardiovascular disease risk in diabetic patients. For diabetic patients with ESRD, many if not most of these patients have serious comorbid conditions that unfortunately are irreversible and difficult to treat. (here)

In addition, the median age of the incident ESRD population is 64.2 and the median age of the prevalent ESRD population is 59.4 .  For those considering emplyment as the main focus of lobbying congress to change dialysis outcomes,  the fact that we have at least half of the ESRD patients in the US above the working ages limits its application except to a fraction of the current population. The demographics at the time of the origins of the ESRD program in 1973 no longer exist. I believe we have rightly extended coverage to all patients who wish to be treated and should continue to do so. There are certainly renal replacement candidates that will not benefit from dialysis due to excessive burdens of disease but that is an individual question for each patient and their families to decide. I do believe we have a societal duty to prevent death and suffering when we have that ability.

Currently, there are only ~18% of the working age dialysis patients that continue to engage in active employment. (here) One aspect that has not yet been completely elicidated is what are the modifiable factors that could improve employment rates among dialysis patients. Patient characteristics such as educational status and occupation prior to iniating dialysis are fixed. Evaluating employment based on facility characteristics is an area in need of further study. Two variables found by Kutner et al in 2008 were access to evening dialysis sessions as well as facilities that have a home dialysis program. Both factors significantly correlate to higher levels of employment. There are likely many other factors that should be explored. 

Taking into consideration the burden of comorbid diseases, we must ask what goal of employment is reasonable? We are currently employing 35-40% of working age dialysis patients. If the goal is set too high in such a system of evaluating dialysis units according to employment rates of eligible patients, those truly that are disabled with irreversible conditions could be forced into a situation where their safety net is removed. Even if we increased employment rates by a factor of 100% (70-80% of working age patients) from current levels which I doubt anyone believes is achievable, the total unemployment rate among dialysis patients would still be near 65%. Focussing on employment alone does not achieve the desired results since the majority of dialysis patients by age or severe disability are not candidates to continue or return to work.

I do believe that we can and should improve all quality of life indicators but do so the same way that Dr. Scribner advocated over forty years ago, by applying physiologic renal replacement strategies best deliniated by Dr. Carl Kjellstrand in his "Unphysiology Hypothesis" in 1975. More frequent and longer duration dialysis improves mortality, reduces hospitalizations, significantly reduces the costs of treatment and conversely also raises the number of patients who are able to return to work. (here)  Employment in the end analysis is one indicator of optimal dialysis. Lower mortality, reduced depression, improved sexual function and many other indicators likewise optimize when patients obtain longer duration and more frequent dialysis. 

I would hope that we continue in Dr. Scribner's tradition of calling for incentives for home hemodialysis, avoidance of high ultrafiltration rates and longer and more frequent dialysis sessions as all other nations around the world have already practiced for decades. Setting employment quotas gains nothing at all if you don't first fix the underlying problem, our unique American dialysis practices. That has and should continue to remain our focus as dialysis advocates seeking reform. Under employment is the symptom, not the disease.

Designing an entire medical program around one symptom alone is not prudent in my opinion. Designing the system as Dr. Scribner advocated for decades remains our one and true course we should all join together to support. Indeed, there are many indicators that Dr. Scribners life long advocacy was not and is not in vain.  His message matters today more than ever as we begin a dialogue among all involved in the care of dialysis patients. Simply breaking down the wall between part A and Part B would drive the financial incentives to avoidance of hospitalizations and complications. In the end, the best medicine once again turns out to be the cheapest medicine.

Utilizing our current resources with improved financial incentives offers much more hope of true dialysis reform than any other method. Interestingly, that is the message that the large dialysis organizations are also lobbying for with CMS/Congress at the present time. I believe that a convergence of the LDO's, CMS/Congress and patient organizations is not only possible, but it will happen. Putting that system together should be the dominant goal of our outreach and advocacy.

LDO's and for-profit medicine are a reality of American medicine whether people are satisfied with that answer or not. Unleashing the properly incentivised goals of dialysis care will bring about the corporate response we wish to see with better outcomes for all patients, not just a select few who are capable of employment. Recent CMS demonstration projects show that this is not only feasible, it is desirable. (here) Interestingly, FMC already demonstrated these same types of outcomes with their joint Kaiser/FMC dialysis partnership in Southern California. I can readily assert that I have personally witnessed the results at my own dialysis unit as both a physician and a patient where my nephrologist was able to reduce annual mortality from over 20% down to only 7% in 2009.  

We already have the tools available today to more efficiently utilize our current resources in a better fashion for all patients. Applying these simple concepts to dialysis care was the basis for Dr. Scribner's visionary recommendations. It remains my central core strategy and goal as well. 

Standing Tall with Shad Ireland: Kona Inspired

By Peter Laird, MD

Shad Ireland is one step closer to a lifelong dream of competing in the Ironman World Championship at Kailua-Kona, Hawaii by charging into first place in the Kona Inspired competition. A little of two weeks ago, Shad was a long shot with over 25,000 votes to make up. In a remarkable turn around, Shad leaped into first place today now with over 43,000 votes and climbing. The dream of competing in the Kona Ironman World Championship saved Shad's life through inspiration. Shad remembers where he came from and wants to use the Ironman competition as platform to bring attention to the plight of the American dialysis patient languishing in disability. Many well known athletes are already standing tall with Shad as he prepares to re-enter the triathalon racing circuit. (here) In 2004, Shad became the first dialysis patient to complete a full Ironman competition and is still the only one.

IronShad the Ironman

I am proud of my Ironman accomplishment. It was one of the hardest things I have ever earned in my life. Yes friends I earned the right to be included into a very special group of athletes, athletes who understand pain, dedication, perseverance, and sacrifice. We all bleed on that 140.6-mile journey together. The mind leads and the body painfully follows. Ironman training taught me to become comfortable with being uncomfortable for long periods of time. It also saved my life, and it made me the man that I am today. A man dedicated to the service of others. A man who understands the gift of athletics and the influence we yield as athletes.

A close friend said to me last week, “Why are you returning to Ironman? You have already climbed that mountain. It’s not like you have to climb it every week. What are you trying to prove?” My return to Ironman is personal and public. Personally, I am returning to the sport of triathlon and specifically Ironman distance because I made a promise to myself and I have a dream to fulfill. We all chase Kona in our dreams! Publicly I am trying to inspire a community that has for the most part become disconnected and given up. I see my reflection in the eyes of the patients I meet everyday. I see the debilitated man I used to be and I feel a responsibility to reach out and take every hand and lead them out of the nightmare that a CKD/ESRD diagnosis delivers.

Life expectancy for someone given this diagnosis is only 2-5 years without a kidney transplant. The median wait time for a transplant is now almost 6 years! The odds are stacked against us but if I can continue to pursue my dreams after 3 decades with this disease then the 1o year old boy who I met two weeks ago who sits connected to a dialysis machine 6 hours a day, 3 days a week can hold on tightly to his dream of becoming an athlete, a Fireman, an Actor, and President of the United States!

I am now coming into my 30th year of living with this disease. My return to racing represents the possibility of it all! At the end of the day I want others to understand that despite my diagnosis I am pursuing my dreams and living my life. I am living the Ironman mantra, ANYTHING IS POSSIBLE!

(See Shad's Schedule here)

Several companies are now sponsoring Shad including Argon Bicycles, Rudy Project, and Shimano. Sadly, to date, despite all that Shad has done for the renal community, he has no sponsors currently from any of the dialysis industry outside of Amgen and Ascend Clinical who are supporting Baseline, an interactive self help program for renal patients through the Shad Ireland Foundation. Shad continues to demonstrate his perseverance to accomplish his goals and to help others do the same. Join me in voting for Shad who is our representative for renal disease and wants to bring his message of hope to Kona. If you haven't voted yet, please do vote for our own dialysis champion now in first place at Kona Inspired. I know Shad appreciates all of your support which he deserves and much more.

Victor Gura's Wearable Artificial Kidney: The FDA Approval Path

By Peter Laird, MD

The FDA Innovation Pathway recently selected three new technologies for this new program. Dr. Victor Gura has been testing prototypes of his WAK for several years and now will focus his future efforts through a collaboration with the University of Washington in Seattle. Many patients have expressed interest in this new and exciting technology that promises a new level of renal replacement therapy rivaling transplant. Looking at data from an earlier prototype compared to standard therapies illustrates well the potential of this modality.

In this graphic representation, the prior WAK prototype achieved 25 ml/min clearances. Keep  in mind that his latest prototype achieved 40 ml/min clearances specifically designed to deliver a large enough clearance to allow children to grow. Even at 25 ml/min clearances, the WAK would deliver more total daily clearance than daily nocturnal treatments currently achieve. The FDA path to approval was also considered in the application for the FDA Innovation Pathway. 

These five successive clinical studies will have to show significant benefit and no harm to the patients as the trials progress through these individual stages. All of these proposed trials will be randomized and controlled. The FDA approval of the path to marketing this device sends an important message throughout the dialysis industry. The future of renal replacement treatments not only with this device but many other proposed medical devices also working their way through the system should give all with ESRD a new hope of a promising future.

There were thirty two new technologies submitted for approval of this program and the FDA chose these three as the starting point of the new Innovation Pathway.  The fact that we have over thirty new devices developed far enough to consider human trials gives us all hope that the treatments of today shall soon be eclipsed by superior devices. Dr. Gura's WAK opens the doors for a new future and I look forward to seeing the developments of this technology in the next few years.

(Slides courtesy of Dr. Victor Gura)

Shad Ireland is Kona Inspired

By Peter Laird, MD

Shad Ireland is living the dream he has had for years as he seeks to participate in the Ironman world championships in Hawaii. Shad was told that he would never be an athlete, that he would never graduate college and that he would never get married. As Shad states, he has accomplished all of these things. As he lay on his mothers couch as a young man after a failed transplant weighing only seventy five pounds, he saw an Ironman competition on TV which inspired him. Several years later, he became the only dialysis patient in the world to compete and finish and ironman competition earning in toil and sweat the nickname, IronShad.

Shad is now Kona Inspired and needs your vote to be able to complete his lifelong dream to enter and complete the Hawiian championship Ironman. Shad has inspired me for several years. Not only has Shad completed ironman competitions, he has also given back to the renal community inspiring other dialysis patients to engage in regular exercise which can be life changing as it was for Shad. Help Shad achieve this lifelong goal by going to his Facebook Kona Inspired page and voting for him over and over again. Shad has paid his dues to the renal community.

I hope that the renal community will stand up in support of IronShad who continues to be an inspiration for so many. I have placed my vote, it is time for all to now send this champion of dialysis and fulfill his lifelong dream. Time is of the essence as the chance to vote will soon come to a close and you can vote more than once. I plan to vote several times a day and help send Shad to Kona. IronShad deserves our support as one of us lives his dream.

The Lufkin DaVita Bleach Murder Trial: The Verdict is in - Guilty of Capital Murder

By Peter Laird, MD

The long awaited trial of Kimberly Saenz is now history with the jury rendering what I thought was a surprising verdict of guilty of capital murder in five cases and aggravated assault in three of five cases. I respect the voice of the people even though I personally disagree with the outcome.  I truly do not believe that the medical evidence proves that any murders or assaults occurred, but the jury has spoken and I respect their efforts in this complex and taxing case.

Jury finds ex-Texas nurse guilty in bleach deaths

LUFKIN, Texas (AP) - A former Texas nurse accused of killing five of her patients and injuring five others by injecting bleach into their kidney dialysis tubing was found guilty of capital murder Friday.

Kimberly Clark Saenz, 38, was fired in April 2008 after a rash of illnesses and deaths at a Lufkin dialysis clinic run by Denver-based health care giant DaVita Inc. She was charged a year later.

Her trial began March 5. Defense lawyers argued that Saenz was being targeted by the clinic's owner for faulty procedures at the facility, including improper water purification. They also suggested that officials at the clinic, about 125 miles northeast of Houston, fabricated evidence against Saenz. Prosecutors described claims Saenz was being set up by her employer as "absolutely ridiculous."

The mother of two now faces life in prison or a death sentence as the case moved to the punishment phase. Prosecutors had said they would seek the death penalty if Saenz was convicted.

Kimberly Saenz awaits the final aspect of this trial, that of sentencing where she could face the death penalty. In the end, God's judgement will be all that matters for each and every one of us. God offers forgiveness and salvation to one and all. My only prayer at this time is that the people of Lufkin Texas can be at peace with the terrible tragedy that has occurred in this small town for all involved. Certainly, there are many who have suffered terribly. It is also my hope that the verdict is true and certain since the potential penalties are harsh.

Hopefully after the penalty phase of the trial is completed, one or some of the jurors will explain how they viewed the evidence of this case that for them appears to have been without any reasonable doubt. It is their right to remain anonymous and silent, but I believe many will wish for a discussion by the jurors at some time in the future.

Once again, the jury has spoken and we must all abide and respect the great personal sacrifice that they took upon themselves to accomplish their duties as citizens of this great nation whether we agree or disagree with their verdict.  May God be with us all in this and all matters as the jury now will decide her fate on life in prison or whether they will apply the death penalty to this case as the case now enters the punishment phase.

Shad Ireland Joins Charity of Choice in Partnership

By Peter Laird, MD

Shad Ireland, the first dialysis patient to complete an Ironman competition is joining Charity of Choice in partnership. To promote this new partnership, Shad will ride in the Bicycling Magazine Open in Philadelphia June 3, 2012. Shad remains active in promoting exercise as a key to improving patients lives on dialysis.

IRONMAN AND DIALYSIS PATIENT SHAD IRELAND PARTNERS WITH CHARITY OF CHOICE. HE IS SCHEDULED TO PARTICIPATE IN THE BICYCLING MAGAZINE OPEN IN PHILADELPHIA

March 27th, 2012 – Minneapolis, MN – Following a grueling week of training Ironman Triathlete and dialysis patient Shad Ireland announces a partnership with Charity of Choice to participate in the Bicycling Magazine Open in Philadelphia on June 3^rd. The dynamic Ireland who is scheduled to return to Ironman triathlons this year will ride in the charity event prior to the professionals taking the course. Ireland and Charity of Choice will work together in 2012 to promote individual and corporate social responsibility and charitable impact at the community level. Ireland stated, “It is an honor to work with Charity of Choice because they provide a unique platform for individuals and athletes to really make a difference for the charity of their choice.”

Charity of Choice gives any individual, business, or charity the ability to set up fundraising pages around any event and for your charity of your choice. Charity of Choice’s CEO is Hunter Ziesing, a health and fitness advocate who is outspoken about health issues when it comes to diet and exercise avoid costly and what can be avoidable health issues.  “Shad’s story to me is not just about defying odds but he sends an important message not only to those affected by disease but to those who can avoid it.”Ziesing’s younger brother was lost his kidneys and spent over three years on dialysis. 

“By riding in the Bicycling Magazine Open in Philadelphia on June 3rd, I hope to inspire people in this country as well as the millions affected by kidney disease across the world to take action and get healthy,” said Ireland. “My biggest goal is to show those who are suffering that anything is possible, no matter the obstacles,” said Ireland.

Shad Ireland has been an inspiration to thousands of dialysis patients in this nation and around the world. He is now entering his thirtieth year of renal replacement therapy. Shad is living his life at its fullest and continues devote much of his energies to inspiring other dialysis patients to engage in an active life. I continue to wish him the best in all that he pursues and we will eagerly await any news of his upcoming events. Shad's story is truly one of inspiration that all dialysis patients should follow in earnest. What he has accomplished in the past points to what he continues to seek and achieve. Once again, we wish Shad the best in his endeavors now and in the future.

The Lufkin DaVita Bleach Murder Trial: Is HemoDoc a Reporter?

By Peter Laird, MD

As the Lufkin DaVita murder trial winds down to its conclusion, it is interesting to follow the news reports as well as all of the comments at the end of most of KTRE's articles. In the last couple of days, there has been a bit of a debate over how accurate my "reporting" of the case has been.  I would like to make a few clarifications. First, I am not a reporter. I am a medical doctor with a blog where I voice my own individual opinions of various issues. If you are looking for both sides of an issue as an unbiased news reporter, you will likely be disappointed since my opinions are mine alone. I do strive for accuracy and presenting the discussion clearly, but in the end, these are my opinions based on an extensive review of the medical issues involved in this case and should not be mistaken for news reports of any kind. Instead of viewing this as a news report, think of it instead as an opinion page since that is exactly what it is. In such I hope it is an informed opinion of not only the Lufkin DaVita murder trial as reported in the news to date, but all the issues that I comment about on HemoDoc.

Defense rests in bleaching deaths Trial

J: Like I said before, unless you have sat through every session and heard evidence/testimony yourself, you really have no idea of the specifics of this trial. The jury will do it's job and whether we like it or not, we have to respect it. As far as hemodoc reporter, reading evidence and hearing/seeing evidence is two different things. I am sure he is a well educated man, however, his accounts of testimony and credibility of witnesses on stand cannot be accurate if he is not in the courtroom. The evidence is detailed, lengthy, scientific, confusing at times. All I am asking is that you respect the job the jury has to do, no matter what the outcome, based on what they have witnessed and not what is reported on this site. 

Another issue is whether I have been in the court room and the answer is no, I have not gone to the Lufkin DaVita courtroom. Instead, I have reviewed the daily news accounts and during the course of the trial, I have limited my opinions only to that which has been publicly reported in the news. I did not during the trial venture beyond news reports to remain within the bounds of the information I already possessed but may not yet have been brought up in court. Obviously, being limited to the information available in the news is not the best way to comment on a trial, but it was all that was available during the trial and it was also all that was appropriate to comment on as well.

That being stated, the news reporting of this case from KTRE and Lufkin Daily News in my opinion was very biased against Kimberly Saenz. In addition, I have added sources to my opinion many of which were not included in the testimony but are well documented in the medical literature and easily found on the internet. I am not sure why that is not a valid manner in which to formulate an opinion of the medical issues discussed in this trial.

Unfortunately, the CDC did not in my opinion complete their task by establishing 3-chlorotyrosine levels in dialysis patients with heart attacks, pneumonia and cardiac arrest or sepsis nor in separating other causes of chlorine sources. Nor did they consider or discover the abnormal chlorine levels in the water that Deaton brought to light. So just sitting in the courtroom didn't give you all of the evidence of this case either. There is much more to this story that can't be told yet in part because of what the judge has disallowed. Hopefully same day that will be known as well.

59th Annual EIS Conference (page 24 of pdf flyer)

DONALD C. MACKEL MEMORIAL AWARD 

Cardiac Events and Deaths in a Dialysis Facility Associated with a HealthcareProvider — Texas, 2008 

Melissa K. Schaefer, C. Lucero, M. Sochaski, R. Kleiman, J. Su, M. Arduino, A.Kallen, M. Schwartz, P. Patel for the Texas Dialysis Investigation Team 

I believe that the CDC has failed especially since they had over four years to prepare for this case. I do believe that Ryan Deaton has been able to elucidate the issues well and I believe that the jury will have the credible information to make an informed decision. I also believe that if Kimberly Saenz is innocent of all charges, then we must ask the question, who is responsible? I believe that the medical evidence provides that answer as well but that will be for the jury to determine. 

For now, it is the jury's time to reflect on the evidence and then speak of their opinions of this case. Their opinion in the conclusion of this whole matter is all that will be relevant anyway. I believe that the trial has brought out the most important information for them to make an informed decision and that is sufficient for the task at hand.  We await that judgement. How the jury will respond is impossible to predict at this time.  There are many on boths sides of the equation hoping for the verdict they believe is correct. Once again, may God be the judge.