Thursday, May 22, 2014

Wall Street Journal Reports Collaboration between DaVita Clinical Research, Aethlon Medical and Stephen Fadem

Aethlon Medical announces definitive agreement with DaVita Clinical Research, selecting DaVita Medical Center as their study site and Stephen Fadem as their principal investigator.

Here are Steve Fadem's comments:

We will be studying the Aethlon Hemopurifier®, a novel therapeutic device that targets the rapid elimination of viruses like hepatitis C and the tumor-secreted exosomes that can suppress the immune system in cancer patients.

Exosomes are vesicles created by the cell that can fuse with the cell wall membrane leading to the release of waste products. These products can be used as biomarkers for disease. However, the cell seems to use them for sending signals between cells or for waste management. Since the excreted exosomes can transfer "cargo" of molecules that may suppress the immune system, they may allow pathogens and tumors to adapt and grow. They may enhance angiogenesis and metastasis. Efforts are underway to further study the role of exosomes in disease pathogenesis. Meanwhile, we are collaborating with Athleon and DaVita Clinical Research to find ways to remove viral particles and ultimately exosomes from the circulation.


The National Kidney Foundation presented Pump-a-licious at River Oaks Country Club, May 22, 2014. The show was hosted by Neiman Marcus. Drs. Stephen Fadem and Wadi Suki each received the Glass Slipper Award for their contributions to kidney care.

Thanks you, National Kidney Foundation, for selecting me as an honoree today. I could not think of a finer person to share this honor with than Dr. Suki, who has always served as my role model and inspiration.

In 1969, a first year medical student volunteered at the Children's Ward. There I met Floyd, a cute 4 year old. Bubbling over with joy to see us, he always raised his little arms to hug us. We cared for him sevral weeks before he dwindled and died. Floyd had kidney failure, but was not eligible for dialysis.

The moment of his death gave my career purpose - I vowed from then on that I would strive to help to kick out kidney disease. It has been a long journey - 45 years.

I have been most fortunate my wife, Joyce, has for the last 40 of these years, stuck by my side as a companion, the mother of our incredible children, my friend, my soul mate and my critic. Our life is rich and full of happiness, and to her and our family I express profound gratitude.

My career centers around Kidney Associates, DaVita, Baylor and volunteerism with organizations like NKF. It is all of you who deserve the credit, and to all of you that I owe a great deal. Thanks for contributing to what has been a fabulous career and life.

Receiving an honor for merit always challenges the recipient to continue living up to the distinction, and I pledge to always try to do so here.

Thank you again

Monday, February 27, 2012

...highly recommended to a broad range of readers - Nathan Levin

Nathan Levin reviews Issues in Dialysis

Current books on dialysis consists largely of two types of publications; one is handbooks of practical instruction for physicians, nurses, technicians, social workers and dietitians and the other is encyclopedic works emphasizing the physical, chemical and biological aspects of various types of dialysis and including the wide range of psychosocial issues characteristic of this interesting subspecialty of nephrology. An interesting new book, “Issues in Dialysis” edited by Stephen Z. Fadem brings together individual viewpoints on a variety of current topics. It is a substantial work of 20 chapters, generally very readable, and is a good representation of current opinion.

The book begins with the description of 20 milestones in dialysis (with emphasis on the US) by Fadem which incorporate technical progress, process, access development, dialysis as an industry, dosing of dialysis, ESAs and practice Guidelines, transplantation, and government action . Golper and Schreiber provide a powerful argument for an integrated approach to therapy in regard to modality choice and site of treatment, communication and education with patients is stressed. Amy Friedman focuses on the range of decisions implicit in the variable quality of donor kidneys and provides a novel analysis of the expectations of the stakeholders associated with transplantation including patient, surgeon, nephrologists to payer, etc. Chris Blagg contributes a characteristically polished history and evaluation of the Seattle home dialysis experience. Badve, Hawley and Johnson take up the must discussed question of clinical outcomes comparing PD and HD pointing out most evidence is derived from observational studies. In their Chapter on intensified dialysis in children, Thumfart and Muller present this approach as a promise to improve symptoms and psychosocial rehabilitation.

Victor Gura provides an impressive argument for development of a wearable artificial kidney, referring also to his considerable personal experience. In a thought provoking essay, Susan Bray deals fully with the issues involved in not automatically dialyzing everybody. She emphasizes the RPA guideline on withdrawal from dialysis and the concept of the “time limited trial”. Richard Glassock convincingly provides the basic arguments for the primacy of extracellular fluid overload as the major mechanism for development of left ventricular hypertrophy, the difficulties faced in determining its degree and possible therapeutic approaches to its eradication. In one of the few Chapters devoted to basic science, William Mitch fully but lucidly describes the enzymatic mechanisms underlying muscle wasting in kidney disease as influenced by events occurring in chronic kidney disease such as acidosis, inflammation, increased glucocorticoid production, etc. Allon Friedman, answering the question of the value of serum albumin as a useful marker of nutritional status, convincingly demonstrates its importance as rather a marker of illness. The Chapter on the deregulated immune system in dialysis patients by Grabner, Pavenstadt, Lang and Reuter is important because of the relative novelty of such reviews but also because of its breadth of topics, valuable tables and extensive references. Over activation and malfunction of the immune system is demonstrated from the early stages of CKD until loss of kidney function occurs.

Hruska, Fang and Sugatani emphasize the close relationship in CKD patients between low turnover bone disease and vascular calcification and clearly describe the roles of bone regulatory proteins and new skeletal hormones and inorganic phosphorus concentrations. New therapeutic approaches are suggested. Perhaps the most comprehensive Chapter of the book is the 30 page update on anemia and kidney disease by Goli, Pinkhasov, Landry, Chait, Horowitz, Hollot, Shreshtha and Germain. It deals in detail with the physiology of erythropoiesis in CKD, current questions of ESA dosing and resistance, iron metabolism, hemoglobin variability current controversies and much else related to this field.

The somewhat neglected field of accumulation of toxic metals and trace elements in dialysis patients is examined by Yen, Lin-Tan,and Lin. They point out the importance of trace metals, particularly lead and cadmium, but also chromium, copper and vanadium as contributing to a variety of pathological processes in patients with kidney disease.

James Tattersall’s Chapter on adequacy of dialysis is a remarkably well balanced assessment of the meaning of the term and its application. Dose, different schedules, removal of solutes of various sizes, clearances in vivo and in vitro and normalization of such in HD and PD, various models of pool size and a list of relevant RCTs are lucidly discussed and practical advice given.

Syed and Peden provide a very useful essay on the AV fistula which includes its history and the approach to create and maintain fistulae and to handle dysfunction. They point to current investigations to reduce neointimal hyperplasia and the future represented by tissue engineered blood vessels. Anaya-Ayala, Davies and Reardon define the general considerations regarding CVD and its risk factors in dialysis patients before describing pre-and post operative management and outcomes. They suggest that prevention is the most effective treatment.

Dori Schatell reviews the concept of health-related quality of life as evaluated by various measures including that of the SF36 and the Kidney Disease Quality of Life. This detailed account is singular, CMS (US government) requirements for such measurements are detailed and practical use of the instruments is clearly presented. The book ends with a succinct discussion of integrated Renal Disease Care by Franklin Maddux initiated by the Institute of Medicine’s document “Crossing the Quality Chasm” and being developed by The US Department of Health and Human Services. The task involves, inter alias, patient population identification, care coordination, CKD and ESRD interventions and eventually introduction of accountable care organizations. These may be major advances in care in the US.

The book with its international authorship and its broad range of issues, presents a fascinating picture of current writing on dialysis. It is highly recommended to a broad range of readers.

Monday, October 31, 2011

Don't lose sight of the big picture in health care

I went to the Okavango Delta this summer. We were supposed to be hearing a discussion about the indigenous grasses of South Africa. Somehow I just couldn't focus. This photo typifies health care in the USA. We are all trying to follow an agenda, which is at best a blur when one gets sight of the big picture. We complain about the high costs of the transition to dialysis, yet...

Saturday, October 15, 2011

CKD 2011 (The Fadem Symposium) A huge Success

Since 1988 the National Kidney Foundation has sponsored a symposium in Houston. It has always featured top experts. This year was no exception. Many new concepts were revealed to the Houston community of nephrologists, nurses, administrators, social workers and dietitians. Myles Wolf started the sessions, and presented key new data from his recently published JCI article J Clin Invest doi10.1172/JCI46122. This showed that FGF-23, a hormone that rises to keep the serum phosphorus in balance in CKD, was directly toxic to cardiomyocytes, leading to an increase in cardiomyocyte, hence left ventricular hypertrophy. This was independent of klotho, previously thought to be needed for FGF-23 activity. It was demonstrated with an antibody that neutralized FGF-23. Also, in animals treated with that antibody, 1,25 OH D3 levels normalized. This has several implications: 1) it makes it desirable to want to keep FGF-23 levels low in CKD – and since the antibody is not available as a pharmaceutical (yet), we should try to minimize inorganic phosphorus intake. 2) it suggests that vitamin D activation is impaired by FGF-23, not because of reduced renal mass.

Tom Golper’s talk highlighted a paradigm shift in thinking of long term strategies when planning dialysis therapy. He also brought out that in the elderly population with multiple comorbidities, the outcomes were no better with dialysis than without. There are now several studies demonstrating this NDT (2007) 22(7):1955-1962..

Allen Nissenson outlined the need to integrate health care. The current health delivery system that splits care among a variety of different providers and competing resources is wasteful, and even with the strictest varieties of health reform, will never be cost effective. It is not sustainable. The best system is to have an accountable organization manage the patient’s health care. Concerns that large non-renal groups, be they hospitals or health plans, will not focus on the care that our patients require, and that decision making is best made by those providers and physicians who are highly familiar with kidney patients' special needs.

Amy Friedman started her lecture by asking each of us to look around for a spare kidney, under chairs in bags - and they must be live kidneys. (None found). If we could not find any, she would have to give her talk. She started with the UNOS dialysis trends – there are over 112,000 people waiting for a transplant (UNOS). In her discussion, she went over terminology changes that were more sensitive to the feelings of donor family members whose loss led to the gains some of our patients enjoyed. (The concept of mourning transcends human experience, as evidenced by the National Geographic quality photographs she took in Puerto Rico of a gila monster grieving over the death of another). She focused on the need for more organ donation, particularly through using extended criteria donors – matching older patients who needed a transplant with kidneys that were recovered from a like population that might be too risky for a younger population. She also focused on the barriers to a successful transplant. Sadly, some of these barriers are regulatory. Doing special viral testing within a few hours of a transplant would only increase ischemia time, and lessen the changes for a successful kidney. Another conundrum revolves around outcomes management. According to outcomes criteria the late Steve Jobs, the well loved founder and CEO of Apple, would have been a poor choice for the liver transplant he received June 23, 2009 because he did not survive for three years afterwards. However, in the two years he did survive he introduced to the world amazing products, including the iPad many of us are using at this moment. There is, however, no app to tell us exactly who will and will not do well with a liver or kidney, and human input and sound clinical judgment are still invaluable.

The day ended with Dr. Emil Abdulhayoglu talking about the various types of AV access. In addition to the standard definitions, however, he explained in a simple and understandable way, the physics that leads to varying outcomes between the different types of access. He very skillfully explained the clinical assessment of a fistula, emphasizing the need to feel the thrill along the fistula tract. The consequences of venous scar build up are venous stenosis or obstruction. Scar formation can appear very early after surgery. One drawback is that the resultant stenosis interferes with the normal maturation of the fistula wall, and the venous wall never develops the muscular change that enables it to seal off after a needle stick. All too often we encounter an infiltration when attempting to cannulate a young fistula that has not properly matured. This failure to mature is likely the result of obstruction that is easily repaired through early intervention prior to the initial cannuation attempt.

A few hiccups with audiovisual equipment not working properly were mostly a nuisance, but did not interfere with the speakers' messages. Unfortunately, Tom Parker was unable to make the symposium as planned, and the audience missed hearing one of the finest doctors in our profession speak to how we can improve the care of our patients. But, Dr. Parker promises to reschedule his trip to Houston, and will be welcome at CKD2012.

Stay tuned for information about the next symposium.


Wednesday, November 10, 2010

The Dimensions of Dialysis

The Dimensions of Dialysis
by Stephen Z. Fadem, M.D., FASN
A Response to God Help You, You're on Dialysis
Atlantic Magazine, December 2010

God Help You, You’re on Dialysis is an investigative journalism article that appeared in the December 2010, Atlantic Magazine. It tries to explicitly highlight everything that is wrong with dialysis. This dismal picture, however, is strictly one-dimensional.

Dialysis has emerged and progressed since 1972 as a life-saving gift to people who earlier would have died. In 1969, while in medical school, I saw a four-year-old African American child die with uremia because he did not qualify for dialysis. Through the years since then we have honed our skills and greatly expanded the dialysis program. In many countries, there is no government financial support of dialysis therapy, and as a result those patients who cannot afford care succumb to their illness. We now dialyze an older set of patients and have less hospital time. We are identifying outcome measures that simply do not work, and creating plans to identify and strongly support those that do. We are looking at what is best about dialysis in other countries and incorporating that into our efforts to care for patients. At the same time, we are now more focused on the quality of life and on educating patients well before they ever require dialysis. In this fashion many patients can select to preemptively undergo a kidney transplant or choose a home dialysis modality. Other patients with concurrent morbid conditions may elect not to choose dialysis at all. All of this progress is made despite wanton cuts in funding and critical nurse shortages. Sadly, many patients who enter a dialysis program missed an opportunity earlier in their lives to control their lifestyles and eating habits. The results of uncontrolled obesity, cardiovascular disease, diabetes or hypertension are comingled with inexorably progressive kidney failure.

Like the muckrackers of the early 1900s, whose model was to selectively report the sensational negative aspects within an industry, the author of this paper only looks in one direction. The name muckracker was attributed to Theodore Roosevelt. It is memorialized in a speech that is just as timely today as it was 100 years ago.

“... you may recall the description of the Man with the Muck-rake, the man who could look no way but downward with the muck-rake in his hands; Who was offered a celestial crown for his muck-rake, but who would neither look up nor regard the crown he was offered, but continued to rake to himself the filth of the floor.”

The facts are there; there are problems within the dialysis profession. Many patients come to dialysis poorly prepared, having been poorly educated as to what to expect. Alternate therapies have not been explained to them; they do not have an appropriate access placed, and are unaware of their responsibilities toward their care.

The have been cuts in the program; it is an entitlement and thus engenders a negative reaction among those who are trying to create a fiscally responsible government. Worse, the fear of what will happen next, as new cost containment initiatives are rolled out, has been very unsettling.

In dealing with very human issues, mistakes happen. Unfortunately catastrophes occur in a small minority of instances. Our profession at large is very aware that the potential for an accident or an infection is high by the nature of what we do, and we strive hard to meet our task with an abundance of caution. Most instances are “near misses” and lead to quality improvement processes that improve the system. Ineptitude is strongly addressed internally through counseling, retraining and sometimes employee termination. Some instances of negligence lead to unexpected outcomes, and are dealt with in the court system, and sometimes through state or federal sanctions.

Dialysis facility inspections are performed less frequently because of the lack of well-trained surveyors at the state or federal level. However, internal surveys are regularly performed. A survey at any level is very helpful to a dialysis center – we welcome it an important tool in pointing out deficiencies and weaknesses. It serves to enable the team to receive extra help and advice from outside experts. In the majority of instances there is a period of corrective action followed by another survey. During this time the facility retrains its employees and works through process to develop a stronger infrastructure. Many of these facilities go on to become model units. In some situations, they must close because they fail to meet the standards that not just surveyors, but peers and colleagues expect. Mischaracterization of these inspections through the media by investigative reporters is exciting copy, but harms the scope of a process intended to be corrective, not punitive.

Sadly, the author of this article missed an opportunity to look around at all the dimensions of dialysis, and instead chose the path of the muckrakers of the past, just looking downward and raking filth.

Wednesday, October 7, 2009

Fadem's Flu Shot

We had a lot of fun making this brief video, but the message is important: Patients with kidney failure and their health care workers need to minimize the spread of the flu in dialysis units. The flu is contagious, and can be deadly. Health care workers, like patients, should take the seasonal flu vaccine. This is because if we contract it, we can spread it to patients, who often because of an attenuated immune system, are at a high risk of having a complicated course and a bad outcome. Although low grade fever, aches, soreness, site redness and swelling may occur, these symptoms are self limiting, lasting only one to two days.

The flu shot is made with killed, inactivated virus, so it cannot give you the flu. The side effects of the flu far outweigh the one to two in a million chance of having a serious adverse reaction like Guillain-Barre Syndrome.

Patients undergoing dialysis, as well as those who care for them, should be vaccinated to minimize the risk of the flu's consequences and spread. If you would like more information about the flu shot please contact the CDC -


The flu shot that I took in the video was the seasonal flu shot. It should start working in about two weeks. This vaccine contains the H3N2 influenze A virus, the seasonal H1N1 virus (not the 2009 Swine Flu H1N1) and a B virus. This vaccine does not protect against the H1N1 2009 swine flu. That is a different vaccine. It was just issued, and is currently available as a nasal inhalant. Right now we are not in flu season so those who develop flu-like symptoms most likely have the actual swine flu. There is an online H1N1 flu self assessment test that one can take to determine the likelihood of having the H1N1 Swine flu. Here is the best resource for swine flu: