HemoDoc, From Doctor to Patient

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.

FDA Announces Renal Disease Device Pilot Programs

By Peter Laird, MD

The first projects of the new FDA Innovation Pathway went into effect today with the announcement of three pilot programs for ESRD.

FDA announces plans to pilot end-stage kidney disease technology in new program

Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.

The three products are:

• An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
• A Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
• A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

The majority of the 32 applications came from small, start-up business or academic institutions. 

Dr. Victor Gura invented the Wearable Artificial Kidney (WAK) and has already successfully tested this device prototype in Italy and London. (here and here) With 168 hours of total dialysis per week, it achieved creatinine clearances of 40 ml/min. The importance of a creatinine clearance this high is this is the level that is predicted to allow children with ESRD to grow normally, which was one of Dr. Gura's goals in developing this device. 

The FDA Innovation Pathway is a welcome addition to the renal community and adds a new layer of market place developments that will push the entire industry to a new level never seen before.  With current weekly Kt/V goals of 2.0, this device will push the limits to over 7.0, equivalent and at times exceeding the creatinine clearances of patients with renal transplants. I look forward to the brave new world of renal disease medical devices now coming to the forefront of renal replacement technology that has stagnated for several decades.

The FDA Innovation Pathway promises reduce the death and suffering associated with the standard in-center treatments.  The large dialysis organizations (LDO's) will need to reply in kind as renal replacement therapies now enters a new generation of device innovations. The promise of living independently and unshackled from the burdens of renal disease may soon become the standard treatments for those unfortunate to have irreversible loss of renal function. The news from Washington D.C. today begins a new era of dialysis therapies that the renal community shall surely welcome.

Is American Nephrology Falling Behind Asia?

By Peter Laird, MD

Renal and Urology News recently had an opinion article on dialysis practices in Asia and America where the American nephrology practices for dialysis are no longer cutting edge. America appears to be in a state of limbo as far as dialysis practices compared to other nations, even those that we would ordinarily consider "third world" countries.

Is U.S. Nephrology Laggin Behind?

On the dialysis front, too, other countries appear to be ahead of us. In this country most of us have no clear idea what so-called “on-line hemofiltration” is, whereas in many other countries it has been practiced routinely in outpatient dialysis clinics for years. Our dialysis machines are outdated compared with those of some other nations. We do not allow our patients to eat during dialysis treatment, whereas meals are served routinely in many outpatient dialysis centers in other countries.

We appear to be disconnected from the rest of the world and uninterested in knowing why other nephrology communities are moving forward faster than we are. In terms of income, we feel that we are paid relatively well in this country, yet we do not realize that even Canadian nephrologists, on average, earn 20% to 40% higher income than their counterparts here.

There is no doubt that when it comes to dialysis practices, America has adopted stagnation as their motto. Since the advent of high flux artificial kidneys, the actual technology for dialysis in America has remained essentially unchanged for decades. If we didn't have the highest mortality and cost per capita for dialysis patients, the status quo could be justified. But since our outcomes are so far out of variance from other nations, our intransigence is as noticeable as Rudolf's red nose on Christmas Eve. Sadly, it appears that some American nephrologists think that our system of deterence to new technology is the best in the world.

Brief Comment: Is U.S. Nephrology Lagging Behind

My response to Kam is that the US taking a more measured approach compared to Asian countries represents a strength not a weakness. After all, we have evolved from an era of norstrum and other so-called "magic cures" (e.g., see Warner's Kidney and Liver Cure ad) to a more organized marketplace of treatments that are backed by evidence. We should seek data from randomized trials wherever possible to support treatment recommendations rather than simply using interventions based on limited data and whims.

It is interesting that one of the great difference of American dialysis practices compared to Europe and Asia-Pacific is that thirty years ago, America embraced the NCDS as the champion of evidence based medicine while Europe and Asia-Pacific nations uniformly rejected this flawed RCT and it's illogical conclusions that TIME is not an important determinant of outcomes.  In fact, you could readily conclude that the adherence of American nephrology to these flawed RCT's and blatant diregard of excellent observational dialysis studies is at the center of our failed dialysis practices which are motivated more by profit and greed than any so called evidence based medicine.

Interestingly, the NCDS had a non-significant effect from time on dialysis and the HEMO study did not test time as one of the variables. The FHN short daily study focussed more on differences in frequency and the failed FHN nocturnal study failed to recruit enough patients, it failed to separate the treatment group parameters far enough and it had too highly selected patients with only one third the mortality of the USRDS dialysis population to be able to be generalized to a sicker population.

Time and duriation of dialysis treatments has never yet been properly tested in an RCT to date, nor do I believe it is necessary. In fact, you could argue very determinedly that adherence to RCT's in America is the cause of our stubborn refusal to advance treatment options since many of the questions can never be sufficiently answered with a large enough and powerful enough study. The optimal dialysis RCT is simply a castle in the sky that the academic American nephrology will never realize since it would involve thousands of patients who refuse randomization as seen in the FHN studies.

In such a case, the call for further RCT's suceeds in only inducing further treading of water and maintaining the current status without improving outcomes whatsoever.  It should be immediately obvious that Rudolf's nose which shines so bright is there for all to see, except it appears, the American nephrologist who glorifies in our mediocrity. I appreciate Dr. Kalantar-Zadeh having the courage to speak truthfully. Unfortunately, it was predictable that many in the American nephrology community would take umbrage to his observations and rest on their laurels. After all, nothing is improving despite the serious deficiencies in dialysis practices that DOPPS has documented over the last two decades between America, Japan and Europe. Yes, Rudolf does have a red nose and America is lagging behind in its dialysis practices. Both are implicitly obvious.

Do You Know Your Ultrafiltration Rate (UFR)?

By Peter Laird, MD

Dialysis patients know their monthly hemoglobin levels, albumen, phosphorus, potassium and Kt/V but today, ultrafiltration rates are not published for the patients to review and understand. Sadly, excessive ultrafiltration rates are one of the major sources of morbidity and mortality for dialysis patients, yet CMS does not require dialysis units to report these figures to patients. Many recent studies articulate the risks of taking off too much fluid too rapidly leading to myocardial ischemia and stunning.

Fluid Removal During Dialysis and Cardiovascular Mortality: Results

 

Associations between UFR and All-cause and CV Mortality

Overall, 871 deaths occurred during 5,233 patient-years of at-risk time; 343 of these deaths were due to CV causes. The median survival time was 2.5 years. Compared with UFR ≤10 ml/h/kg, UFR >13 ml/h/kg was significantly associated with all-cause mortality: unadjusted hazard ratio (HR) (95% confidence interval (CI)) 1.20 (1.03–1.41) (Figure 1). When multivariable adjustment was used to account for baseline differences between groups, this association was greatly potentiated: HR (95% CI) 1.59 (1.29–1.96). UFR 10–13 ml/h/kg bore an intermediate association with CV mortality that was not statistically significant: adjusted HR (95% CI) 1.06 (0.87–1.28). Results were similar when UFRs following the long interdialytic break were excluded from consideration, when the referent group was restricted to participants with UFR 8–10 ml/h/kg (data not shown), and when flux and Kt/V treatment group assignments were included as covariates in the statistical model (Supplementary Table SA online).

The effect on mortality of ultrafiltration rates increase dramatically once it is above 10 ml/hour/kg. The calculation is quite easy to do. Using an example of a dialysis patient who weighs 70 kg, dialysis for 4 hours and takes off 2 liters of fluid, we have: 2000 ml/4hr/70 kg = 7.14 ml/hr/kg. However, if we look at a 70 kg patient who dialysis for 3 hours taking off 3 L of fluid, the calculation changes drastically: 3000 ml/3hr/70 kg = 14.3 ml/hr/kg. Shortening the dialysis time and increasing the amount of fluid taken off with ultrafiltration now places the patient in a higher risk of cardiac and all cause mortality.

Secondary Analysis

In order to more fully examine the threshold(s) at which UFR may become harmful, we
conducted analyses in which we examined the association of UFR, represented as a cubic spline, with CV and all-cause mortality. As demonstrated in Figure 3, the HRs for both CV and all-cause mortality rose sharply at values between 10 and 14 ml/h/kg, and to a less pronounced degree at higher values. Consistent with results of the primary analysis, the HR for CV mortality was greater than that for all-cause mortality at all values of UFR.

Just as all dialysis patients receive a monthly report showing URR, Kt/V, Alb, Potassium, Phosphorus and Hemoglobin levels, I believe that the UFR should be a monthly reported matrix as well that should also be tied into the QIP measures. After all, having normal labs and an "adequate" Kt/V and normal URR are meaningless if the patient undergoes concurrent dialysis sessions with excessive ultrafiltration rates that patients can easily calculate for themselves in the comfort of their own homes. I was speaking with Rich Berkowitz earlier today about this issue and he decided to develop a UFR calculator which he has posted on Home Dialyzors United:

 UFR and CV and ALL Cause Mortality Adjusted Hazard Ratio Calculator

Research has proven there is a definite relationship between how much fluid is removed per hour per kilogram of weight.  This simple calculation will allow you to easily see how you compare to the Adjusted Hazard Ratio per the graph below.  You can link to the specific Kidney International research paper HERE.

If your ultrafiltration rates exceed 10 ml/hr/kg, then please discuss these issues with your medical team on how you can avoid excessive risk of cardiovascular and all cause mortality. In addition, if you have an excessively high untrafiltration rate, you are most likely also at risk of feeling nauseous, vomiting, experiencing severe leg cramps and at risk of passing out during dialysis. In addition, if your ultrafiltration rate is high, many nephrologists will place you on a "sodium modeling program" where they add salt to your cleansing fluids that most patients retain after dialysis leading to severe thirst and headaches. In many ways, excessive ultrafiltration rates not only increase your risk of death, they also add greatly to the burden of symptoms associated with dialysis. 

There is a better way to do dialysis and it all starts with longer, slower and gentler dialysis regimens. Short, fast and violent dialysis sessions leave patients feeling drained and at increased risk of heart attacks, chronic damage to the heart and severe discomfort during dialysis. The simple answer is to reduce ultrafiltration rates so that they don't exceed 10 ml/hr/kg. This simple calculation could save your life and make your dialysis sessions easier to tolerate. If your UFR is elevated, you may want to discuss the issues in the Medscape article and consider modifying your dialysis prescription or consider home hemodialysis where daily treatments or nocturnal almost completely eliminate this problem.

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.

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.

The Lufkin DaVita Bleach Murder Trial: What the Defense Must Prove

By Peter Laird, MD

As the defense rests and testimony ends today at the Lufkin DaVita bleach murder trial, comparing the agenda of the defense and the prosecution contrasts what each side must prove to prevail. In many ways, the defense aspects are easier in that the prosecution must prove that the defendant beyond a reasonable shadow of doubt is guilty of the charges as written. The prosecution case was handicapped from the beginning by the lack of any forensic test that is specific for bleach infusion. They didn't exist at the beginning of this trial and I believe it is abundantly clear that as this trial comes to its conclusion soon, it still does not exist.

On the other hand, the defense must only prove that there is a reasonable doubt that the defendant is guilty of all the charges. This is a circumstantial case without any direct physical evidence tying the defendant to the accusations with no fingerprints or DNA evidence reported. Instead, as mentioned in an earlier post, the prosecution case is burdened with the two eye witness accounts that the defendant allegedly infused bleach as they were watching but no direct physicial evidence linked directly to the defendant.

For the defense, the most compelling evidence is the lack of bleach injury on the two autopsies available or in any of the surviving patients. One study that illustrates what the prosecution must overcome is from a recent case report on intentional bleach infusion in a suicide attempt. In this case, the patient placed 20 ml of 5.2% bleach into a 500 ml saline bag and then infused the entire solution. Dr. Schwartz did mention this case in his testimony but he left out a very important aspect of the case report, that of the severe thrombophlebitis that this man developed at the infusion site in his arm:

Venous thrombosis following intravenous injection of household bleach

Abstract

Sodium hypochlorite (NaClO) is used extensively as a disinfectant or bleaching agent. Most studies describe ingestion or inhalation route of this product with rare complication and fatalities. Despite global daily exposures, data about bleach injection is limited. Here we report intentional infusion of 20 mL, sodium hypochlorite 5% diluted in 500 mL normal saline 1.5 h prior admission. Clinical manifestation included local pain and edema. There were no laboratory abnormalities in the patient. Doppler sonography revealed thrombosis in superficial (antecubital and basilic) veins. Limb elevation, warm compress, and ibuprofen relived pain and edema after 3 days

Case report 

 A 30-year-old previously physically healthy man was admitted to the emergency department (body- weight, 75 kg). He attempted suicide by infusion of 500 mL normal saline serum containing 20 mL household bleach (sodium hypochlorite 5%) into right cubital vein with intravenous (IV) line, one and a half hours before admission. He had a history of schizophrenia since 10 years and this was his first suicide attempt. On arrival, the patient was hemodynamically stable. Oral temperature was 37.5􏰁 C (99.5􏰁 F), pulse rate 103 beats per minute with a normal rhythm, blood pressure 135/80 mm Hg, and his respiratory rate was 18 breaths/min with no abnormal breath sounds. The abdomen was soft and flat with normal bowel sounds. The initial oxygen saturation was 95% (in room air). He was alert, awake, and in no apparent distress. He complained of painful swelling in his right upper extremity. In clinical examination, the arm was painful and relatively swollen. 

Dr. Gruszecki noted the lack of physical evidence, the lack of direct forensic evidence and the lack of any substantiated evidence of hemolysis or hyperkalemia in these patients in her reported testimony. We know from the medical literature that bleach reacts immediately with all non-epithelialized tissues. In several cases, the alleged onset of symptoms were up to two hours after the alleged infusion of bleach which is not medically sound or logical in my opinion.

The defense in this case did more than just dispute the prosecution allegations at the patient level, the defense found many serious procedural and professional deficiencies at the Lufkin DaVita facility that raise the case of reasonable doubt. Finding significantly elevated chlorine levels in treated water used for dialysate is a potential answer to the elevated 3-chlorotyrosine levels. The test itself cannot delineate between the two. The fallacy of this thinking is that they appear in my opinion to have put the cart before the horse and assumed her guilt as they built their case instead of seeking all avenues of investigation first before drawing any conclusions. In addition, they had samples from two and five days after the last dialysis which is enough time for the 3-chlorotyrosine levels to fall dramatically as noted in more than one of the alleged victims rendering 3-chlorotyrosine a poor marker of bleach with a very short window to apply its discovery.

The CDC testimony further failed to identify many of the practice variations that has been revealed in this trial such as running the bleach cycle in the dialysis machine between the first and second shift, the fact that the bleach in the blood lines had to be placed after the machine had stopped from Dr. Neidigh's testimony, as well as the widely used syringes to measure bleach for cleaning the machines noted by at least two former employees.

In addition, the defense may have added another layer of reasonable doubt by uncovering the many DaVita actions that bring into question whether they have altered, destroyed or contaminated much of the physical evidence. In the final analysis, it quickly became evident that there is no incontrovertible evidence that any murder or assualt had taken place with any of the patients in this unit. If the prosecution does not prove that the patients were absolutely murdered or assualted with bleach, the eye witness testimony and circumstantial evidence is rendered moot.

This trial shall always generate doubt and uncertainty as to what truly happened at the Lufkin DaVita facility, but there is also much that is now openly revealed by the reported testimony. It remains a complex case where the verdict will remain in doubt until the jury speaks and perhaps even after they speak. Viewing the news and comments, there appears to be a diverse opinion about this case in the public.

The Lufkin DaVita Bleach Murder Trial: What Killed These Patients?

By Peter Laird, MD

The defense has rested in this controversial trial and the prosecution is finishing this morning with its last remaining rebuttal witnesses prior to closing arguments. The witnesses and the evidence is now a matter of record, yet few in the public have heard the evidence presented to the jury already.

In the last week, the defense presented three expert medical witnesses testifying on their independent review of the facts. Dr. Jonathan Neidigh evaluated the physical evidence of bleach and the 3-chlorotyrosine levels found in several, but not all of the patients. Dr. Neidigh testified that in his opinion, the known chlorine breakthrough found on an improperly functioning carbon filtration tank is the most likely explanation of the elevated levels of 3-chlorotyrosine which infused dialysate with chlorine levels fifteen times higher than allowed.

Dr. Neidigh further noted that even those highly positive for 3-chlorotyrosine showed a rapid decline within two days of not dialyzing at the Lufkin DaVita unit. This is even more important when considering the alleged controls for this test from the same dialysis unit didn't have their blood tested until two and five days after their last dialysis at Lufkin DaVita rendering these so called controls meaningless as reported in the news.

Dr. Michael Germain and Dr. Amy Gruszecki completed the defense response to this trial. Dr. Gruszeki is a Pathologist who routinely testifies for the state of Texas and has only testified for the defense in four prior cases. Dr. Gruszecki found no evidence of bleach infusion in any of the patients and noted several obvious explanations for the cardiac events as well as explanations for many of the abnormal labs discussed in this case.  

One case in particular illustrates the illogical conclusions that the prosecution has twisted to fit their preconceived accusations against the defendant. Graciela Castaneda is the only cardiac arrest patient at Lufkin DaVita that survived and later testified against Kimberly Saenz in this proceeding. Throughout the trial, her elevated 3-chlorotyrosine levels coupled with the highest levels of LDH in this group has been touted by the prosecution as direct evidence of bleach infusion. However, I believe that there is a different story.

Dr. Sochaski notes that Castaneda had the highest 3-chlorotyrosine levels (70 times higher than “natural”) and Dr. Schwartz testified that the highest LDH of 2150 was due to hemolysis alone from bleach infusion. In addition, for the defense, none of her blood lines tested positive for any bleach residues.  Reviewing her case in detail, I believe that there is an alternative explanation for the elevated LDH and an absence of corroborating evidence for hemolysis that is objectively documented in her medical record. 

2 Experts testify about computers, bleach poisoning

The lone survivor out of the six, Graciela Castaneda, went into cardiac arrest at 8 a.m. April 16, 2008, and was given a shot of epinephrine at 8:08 a.m., Tortorice said. Twenty minutes later, her potassium level was normal but her level of LDH, a marker for hemolysis, was extremely elevated at 2150. Days earlier her LDH was within normal limits at 219, Tortorice said. Normal is considered 140 to 280.

Whether the patient actually choked on her gum is not confirmed by the paramedic report or nursing note although there are several second hand references to gum being removed by paramedics during the code, but it was not documented by the paramedics or the nurse giving report as evidenced by the rebuttal witnesses today as reported in KTRE (here). In many ways the gum issue may be nothing more than a red herring that does not explain the labs completely nor was there any first hand evidence that it caused this event.

There is no need to consider an alternative explanation of the elevated LDH when acute heart failure secondary to possible myocardial stunning, coronary insufficiency, pneumonia and transient congested liver explain the elevated LDH much better.

I believe that the dialysis nurses may not have realized her possible decompensated state prior to initiating dialysis that morning manifested by an unrecognized pneumonia. What was absent  in this case was any confirmatory evidence of hemolysis beyond the elevated LDH which is best explained by the confluence of issues listed above.  Specifically, the Total bilirubin in this patient was normal which essentially excludes the LDH as being from hemolysis since we would expect an LDH from hemolysis alone to also increase the bilirubin levels as well. 

In addition, the total CPK elevated which would have been consistent with the prolonged CPR causing local skeletal muscle trauma which is also a documented cause of elevations of LDH. Her potassium on initial evaluation in the ER was 3.3. Dr. Schwartz believed that the dose of EPI given by the paramedics would have “masked” the hyperkalemia from his alleged bleach infusion theory. However, prior studies on EPI and other agents in dialysis patients showed only a very modest effect of EPI on potassium levels that is of short duration and plateaus when the receptors are fully occupied by the epinephrine in ACLS doses. 

One aspect that the defense has targeted is the markedly elevated ultrafiltration rates in these patients. During the last several years, multiple studies have shown a correlation between elevated ultrafiltration rates higher than 10 ml/h/kg and increased mortality as Deaton pointed out in court. Castaneda's value approached 20 ml/hr/kg, nearly double the recommended rate. The surprising finding in Deaton's cross examination of this rebuttal witness is that eight of the ten alleged victims all had excessively high ultrafiltration rates with no evidence of hemolysis:

Defense rests in bleaching deaths trial

Deaton then asked the witness about the rate of which fluid is removed during dialysis treatment, called ultrafiltration. According to an article, published in the 2011 International Society of Nephrology, which he references, Deaton says ultra filtration rates of 10 to 13 are high and can be unsafe for dialysis patients. He further says rates of 13 and above is too high for every patient.

"Your risk for cardiac arrest at an ultra filtration rate of 15 almost doubles, and it goes up from there," said Deaton referring to the same article on ultra filtration.

Deaton pointed out that chart records show Marva Rhone's ultra filtration rate (UFR) was 13.8, Carolyn Risinger's was 20.8, and Debra Oates' was 11.8. . . 

. . . Deaton then pointed out to Crumb that from the calculations he's conducted, the DaVita patients listed in the indictment had high UFR's.

"Every single one of Dr. Nazeer's patients had ultra filtration rates over the rate of 10," said Deaton.

Deaton said that the jurors in the trial know more about medical histories, at this point, than the witness. The witness agreed this assertion was true as well as admitted that he did not review witness statements.

The witness testified that he read nephrology articles on a regular basis, although he had not read the two articles Deaton referenced while Crumb was on the stand.

In cross-examination, the witness argued that the process of ultra filtration may be a factor in patient deaths, but the amount of fluid needed to flush out a patient's body could also be a factor.

"The ultra filtration may be a factor," said Crumb.  "The patient that needs the most ultra filtration needs the most fluid."

Crumb argued that there was not extra fluid found in the patients' bodies. He also told jurors he has been in the process of dialysis for the past 40 years.

When considering the evidence in this case, it will be important for the jury to consider that if the prosecution cannot prove that any murders occurred, which in my opinion they have failed to establish, then all of the circumstantial evidence that the prosecution amassed is meaningless. The expert defense witnesses have testified under oath by their own independent evaluations that no murders or assaults occurred but that the practices in this dialysis unit directly contributed to this cluster of deaths and cardiac events. 

I believe it is time not only for the jury to hear all the truth, but the public as well now that all of the witnesses have spoken that will speak in this case and is now part of the public record for all to review if they should desire that opportunity. The entire trial has been video recorded in the court room as well which is also part of the public record of this case. The actual cause of death many times is much harder to discern but often you can exclude specific causes. I believe that the defense has offered evidence against bleach infusion and perhaps contributing factors as well related to this clinic's dialysis practices.

The prosecution expert witnesses, especially Dr. Schwartz from the CDC, have in my opinion over looked well documented evidence of alternative etiologies of these arrests that contradict their assumptions that the only etiology has to be bleach infusion. The method we use to explain abnormal labs is called a differential diagnosis.  That is a basic tool we use throughout medical practice in evaluating symptoms and test results.

An elevated LDH alone is not diagnostic of hemolysis or bleach infusion when in fact, LDH is present throughout the body and not just in blood cells. Any damage to cells throughout the body can result in elevated LDH levels. Since this is so central to the case, I have wondered why no one fractionated the LDH to see which subgroup was elevated. That would have given very important and perhaps exculpatory evidence that is now likely too late to retrieve. These are basic medical student level evaluations of LDH and other labs that I never heard mentioned in any news report. That remains a puzzle to me on how the CDC approached this case.

The Lufkin DaVita Bleach Murder Trial: Is There a DaVita Conspiracy?

By Peter Laird, MD

Throughout the course of this trial, Ryan Deaton has repeated alleged that Kimberly Saenz is a spagegoat for what has gone wrong at this Lufkin DaVita unit and in addition that DaVita has tampered with evidence and hindered the police investigation. Certainly, DaVita did admit to opening the sharps containers prior to calling the police which does bring into question evidence tampering from their own admissions. When we also consider the eight hour delay before calling the police, the eighteen day delay before police were allegedly allowed to speak to DaVita employees after DaVita had conducted it's own internal investigation which the judge did not allow into evidence, then there are many aspects of this case that lend itself to conspiracy theories.

In addition, the carbon "ghost tanks" without proper documentation on why DaVita changed them, the allegation that one of the supervisors would not go down alone, and the janitor's statements also not allowed into testimony that she threw away so many bags of shredded documents the day the police were called that she could not shut the garbage bin all points to a possible DaVita conspiracy to cover-up the real causes of these events. However the most direct evidence that there may have been a cover-up came from the extensive and complex work by Dr. Jonathan Neidigh from Loma Linda University where his research led him to the astounding conclusion that the bleach traces found in some of the bloodlines had to be placed there after the machine was stopped:

Witness says clinic was seeking scapegoat

Spending most of the afternoon on the stand, California-based biochemist Dr. Jonathan Neidigh testified he believes patient lines tested positive for chlorine because it was put there after the fact. Because of the rate at which blood flows through the lines, Neidigh said he believes the blood would have washed away traces of chlorine — more proof DaVita officials planted evidence, according to Deaton.

I don't believe that there will ever be any "smoking gun" that confirms a direct conspiracy at DaVita. At present it is impossible to know whether individual actions either by omissions or commissions may be responsible for these events. It is clear, that DaVita is guilty of one thing, that of not avoiding the appearance of evil as the Bible commands those that follow God's Holy Word.

I Thessalonians 5:22   Abstain from all appearance of evil. 

DaVita, despite all of its high paid lawyers who have haunted this investigation since the beginning and all of its P.R. efforts, still in the end analysis has not avoided all appearances of evil in my opinion. The trial itself takes on a new perspective following the connections of the  the CDC and the Hamner Institute which is also in close partnership with the University of North Carolina (here and here) which on the surface is perfectly reasonable as the N.C. research triangle is one of the most highly technical research centers in the nation. However, understanding that a prominent DaVita board member is also the president of the UNC medical school does not sit well with many that are aware of this "open secret" and how inappropriate those associations appear in a case where the Hamner Institute and the CDC play such a central role for the prosecution in a case where DaVita may be culpable for the events at this unit.

In the final analysis, the issue of whether there is or isn't a DaVita conspiracy in my opinion is irrelevant to the facts of the case that show clear evidence of the defendant's innocence as we have seen reported to date in the news. The distraction of the various alleged DaVita "appearances of evil" will probably not be the most important evidence for the jury to consider nor is there any evidence to connect the different elements to any viable conspiracy theory.

There appears to be a complete lack of evidence for bleach infusion outside of the research test, 3-chlorotyrosine, and that remains the most important evidence for the jury to consider. 3-chlorotyrosine could have been increased from the contaminated water with high levels of chlorine that should have been removed by properly functioning carbon filters.

I believe that if the jury returns a not guilty verdict, the testimony of the expert medical witnesses for the defense will be the final arbiter of justice in this case. However, no matter the outcome of this case, DaVita in my opinion has greatly tarnished its already tainted image from the other legal problems that the company is plagued with. Avoiding all appearance of evil may be something that DaVita considers as it moves forward as this case draws to a close. Abandoning reuse would be a great first step in that direction in my opinion as a public gesture of good will.