TV station reports on bionic kidney project

WSMV News 4, a Nashville (Tennessee) television station, this past week reported on the development and progress of a bionic kidney that is providing hope for the many thousands of dialysis patients across the country.

I came to know of this artificial kidney possibility while researching my book, Dialing in on DI-AL-Y-SIS, and included pertinent information of the progress being made by the two original research collaborators in one of my 16 chapters. The Nashville station’s update on the bionic kidney aired as follows:

There are two options for a person with kidney failure. A kidney transplant or dialysis, a machine that filters the blood of toxins, normally cleaned by healthy kidneys.

Thanks to research conducted at Vanderbilt University Medical Center (located in Nashville) and five other universities around the country, a third option may be available that can mean people on dialysis can lead a normal life as if they didn’t have kidney failure at all.

Right now without dialysis, a person with kidney disease can live for only a few weeks, perhaps months.

A tiny device that can fit in the palm of your hand may be a game changer. It’s called the bionic kidney.

Vanderbilt nephrologist Dr. William Fissell is part of a nationwide team of doctors and biologists who have been working on the device for 17 years. “It’s fair to call it a bionic kidney because it’s a hybrid of technology and living cells,” said Fissell.

It’s been a long journey for Fissell. He hopes to begin clinical trials on the bionic kidney later this year and to get the device to kidney patients as soon as safety permits. “Know that we are doing it as fast as we can, and know that the rest of the country has mobilized in a way you may not expect,” said Fissell.

If the bionic kidney makes that huge jump from clinical trials to where it becomes available to all kidney patients, the implications for someone in renal failure is huge.

“What I want to do is enough, so that sick people can become well, not burdened by the disease, so that patients aren’t stuck to a machine plugged into a wall 15 hours a week, so they don’t have to have a special diet, so that patients don’t have to starve themselves to avoid intoxication with waste products,” said Fissell.

Note: Joining Dr. Fissell as one of the two collaborators in initiating Kidney Project is Dr. Shuvo Roy, the effort’s technical director from his faculty status at University of California San Francisco. The two doctors initiated Kidney Project in collaboration at the Cleveland Clinic in Ohio back in 1998.

This work ethic belongs in World Series

While watching a TV sports show early one morning last week during a dialysis treatment, it was mentioned that the Kansas City Royals (my favorite baseball team) were getting ready to begin their 50th season as an American League franchise. I have been right along on that half century every step of the way, being one of those in the original group of Royals’ fans. Certainly, the highlights have been the two World Series championships (1985, 2015). During my own 50-year career as a journalist, one of my favorite columns centered on a KC player who in the maiden season for the franchise was selected for the American League’s rookie-of-the year award. That particular writing is among my multi-compilation collection titled A Half Century of Writings. The column, written 31 years ago, follows:

(October 17, 1987)

THIS WORK ETHIC BELONGS IN WORLD SERIES

By Bernie Gilmer, Editor, The Belvidere Daily Republican

The field generals on the diamond battlefields today are Whitey Herzog and someone called Tom Kelly. It’s hard to say, but I would be willing to bet a World Series ticket that neither has been down the road a piece from St. Robert, Missouri.

Many generals and their troops have journeyed down the chute from St. Robert to the entrance of Fort Leonard Wood, a sprawling military reservation where Army recruits and “weekend warriors” have had occasions to pitch their footlockers over the years. I pitched mine on that miserable post – somehow Army bases never are listed in travel brochures – twice back in the late 1960s, although the brief, two-week summer camps on behalf of the United States Army Reserves hardly qualified the footlockers as dust collectors.

The summer outing of 1969 did prove to be something special for someone like myself, who found helping to run a mess (dining) hall and serving Army chow less than a career opportunity at that time. It offered a study in human nature as the Army tends to provide a melting pot of the nation’s populace. And each individual element of this olive-drab society does pass through the mess hall for his daily allotment of sustenance, as it were.

Some soldiers pass through mess halls in other than voluntary fashion. Some are placed on kitchen police – a glorified term for duties that include busboys, floor moppers, potato peelers, pots and pans scrubbers and the like. It’s one of the Army’s punishments – do something wrong and you end up on K.P.

That brings us to the summer of 1969. Our unit reported one Saturday morning through the gate at Fort Leonard Wood, settled into some clapboard-sided barracks and promptly got assigned work quarters. For a handful of us, that meant buying (signing for) a mess hall and breaking open some rations for upcoming feasts.

Now that same weekend the Kansas City Royals, playing their first season as an expansion entry in the American League (Charlie O. Finley had vacated his Athletics to Oakland), were involved in a homestand at Municipal Stadium and playing for the most part like the expansion team they were.

The lone bright spot for the Royals was left fielder Lou Piniella, a surprising development as a rookie since he had graced and disgraced several minor league teams since being signed by the Cleveland Indians in 1962 at age 18. Piniella was the first Royal ever to get a base hit, going four for four on Kansas City’s opening day in 1969. He became an instant hero in the Heartland of America, an area where many fans still consider the St. Louis Cardinals the local team and any Kansas City organization merely a farm club of the New York Yankees.

Piniella also became the first Royals’ player to ever scrub pots and pans at Fort Leonard Wood. A member of a reserve component in Kansas City, Piniella elected to play those weekend games and consequently, along with Royals’ pitcher Roger Nelson (a Cincinnati castoff), reported to summer camp a couple moons late. And the two – Piniella and Nelson – promptly were slapped on K.P., which places them under the command of the mess hall cooks. It was only for a day, but what a thrill for someone like me, who is a charter member of the original Royals fandom. Stop by my office and I’ll show you my Royals pennant.

It was also a study in human nature.

Nelson was assigned to peeling potatoes, which he took to with little enthusiasm. He whiled away most of the time tossing potatoes in the air with one hand and attempting to slice them with a knife in the other hand.

Piniella’s approach was quite different. Scrubbing pots and pans is considered the dirtiest, filthiest job in the mess hall – soiling his Army fatigues way before daybreak (K.P. begins about 4 o’clock in the morning) – and when he left that evening (15 hours later) every pot and pan was washed and left hanging in its proper place.

It’s little wonder that few people can relate whatever happened to Nelson and his baseball career. As for Piniella, he went on to become the American League’s Rookie of the Year in 1969. Not too bad for a guy who had lumbered through the minors for seven years with a temper as hot as his West Tampa, Florida, upbringing.

After being signed by Cleveland, Piniella began in Class D with the Selma (Alabama) Cloverleafs. Then – in November of 1962 – he was selected in the Minor League draft by the Washington Senators and the next July traded to the Baltimore Orioles … and then swapped back to Cleveland. During these years, it is possible most players would have found a nice nail for retiring the spikes. Oh, Piniella got cups of coffee with Baltimore (four games in 1964) and Cleveland in 1968 (six games), but never collected a hit.

But Piniella didn’t quit. He kept right on scrubbing. In the expansion draft ahead of the 1969 season – when the Kansas City and Seattle franchises were added to the American League – Piniella had wanted to be picked by the Royals because he had once played for their manager, Joe Gordon. Seattle had the first pick and selected Chico Salmon. Kansas City then plucked Roger Nelson, the pitcher. Piniella then went to the Pilots. But not for long because Piniella then was traded to Kansas City for outfielder Steve Whitaker.

Piniella got off fast with Kansas City. In his first spring training game, he homered off Steve Carlton. And he opened the 1969 season as the Royals lead-off batter and responded with four straight hits. The rest is history. He quickly went from a $12,500 a year rookie ballplayer to become an American League star. Then ahead of the 1974 campaign, the pipeline from Kansas City to New York (the Yankees) vacuumed up Piniella and he became one of the top hitters in baseball for the next 10 years.

And one of his mess hall cooks at Fort Leonard Wood continued to be one of his biggest fans. I always rooted for Piniella to go four for four as long as the Yankees lost. A true Royals’ fan also is a true Yankee hater.

Of course, Piniella two seasons back replaced Billy Martin as manager of the Yankees. And since the Royals aren’t in the 1987 World Series beginning today, I wish the Yankees and their manager were (nothing against Whitey Herzog of the St. Louis Cardinals or Tom Kelly of the Minnesota Twins).

But it is only Piniella who has made that trek from St. Robert to Fort Leonard Wood. I only hope Yankees’ owner George Steinbrenner knows how well Piniella scrubs pots and pans.

NCAA hopes can have their crushing moments

Twice now as a passionate follower of Kansas State men’s basketball have my NCAA tournament hopes been crushed by women. The first time was back in 1964, when K-State was one of the participants in the Final Four at Kansas City. The most recent came a day ago (Thursday, March 22) in Atlanta, where Loyola of Chicago prevented my Wildcats from reaching their first Final Four since that KC hoops spectacle of some 54 seasons ago.

Ever since K-State surprisingly had dispatched the Kentucky Wildcats this past Thursday at Atlanta, I had been thinking about the possibility of my Sunflower State’s Wildcats reaching another Final Four. Much of that consideration came while whiling away time during my early Friday morning dialysis treatment (I was still celebrating from the night before), with thoughts carrying me back to when I had accompanied the Kansas State entourage to Kansas City as the university’s sports publicist.

For a man, it is always demeaning (tongue in cheek) that a psychological setback can be caused by a woman. But this time, there she was – Sister Jean, that spunky 98-year old nun and Loyola of Chicago’s basketball team chaplain for 24 years. She has been a long-time Rambler fan who has witnessed more than a half-century of her team’s basketball history – for almost as long as I have followed my K-State men’s basketball scores. For Sister Jean, though, it would be her school’s first Final Four. My school has reached a quartet of Final Four gatherings (1948, 1951, 1958, 1964), having lost in the championship game to Kentucky in 1951 (I was 10 years old at that time).

The one Final Four (in 1964) that I was able to see first-hand included semifinal match-ups between Kansas State and UCLA and between Duke and Michigan. How that tournament began and how K-State’s basketball team and its fan base were impacted by a group of women is reminisced in a column I wrote two dozen years later while serving as editor of the Belvidere Daily Republican. The column follows:

(April 2, 1988)

POM PON GIRLS STEAL NCAA TITLE

By Bernie Gilmer Belvidere Daily Republican

There are those who contend today’s NCAA semifinal basketball contests and Monday’s title match-up comprise the top attraction in all of sports. That includes the Super Bowl, the Indy 500 and the Calaveras County Frog Jumping Contest.

No doubt about it. Final Four college basketball is big-time. Officials of cities that have hosted the event will substantiate this claim. Ask those in New Orleans where twice in the last six years the NCAA Final Four staging has rivaled the Mardi Gras as an economic draw.

Needless to say, it’s a “really big shew” in Kansas City this season. And so it was 24 years ago when Kansas City last hosted a Final Four tourney. I know because I was there representing one of the Final Four schools – Kansas State University – as sports publicist.

That 1964 extravaganza is a memorable one. Not because of the bitter cold and wintry conditions; those are commonplace for residents of the Great Plains. And not just because I had the opportunity to watch the games in person.

What is memorable is the arrival of the sun-tanned California pom pon girls during one semifinal contest. Also making a distinct impression was the play of a Kansas State team consisting mostly of small-town recruits coached by a very patient taskmaster, Tex Winter. And the fact that the unsuspecting contingent came within minutes of doing something that might have altered drastically the history of college basketball as it was recorded the following dozen years.

On the surface, Kansas State might have looked like it least belonged among the Final Four. Winter’s starting line-up featured a popsicle-stick pivot, two blue-collar guards and one forward who used to sell concessions at rival University of Kansas basketball games as a high school student.

All right, so Winter had one bona fide All-American – a 6-6 forward named Willie Murrell who later that summer led the Olympic trials in scoring but was left off the United States squad by Olympic Coach Hank Iba, the taskmaster at Big Eight foe Oklahoma State. Iba had wanted Murrell, who grew up in the all-black town of Taft (Oklahoma), to come to Oklahoma State. Murrell, however, opted for junior college and then Kansas State.

But possibly the most interesting player was Roger Suttner, the Kansas State center from Ridgway – that’s a Southern Illinois community of fewer than 1,200 residents in Gallatin County (not far from where Illinois, Indiana and Kentucky all share the Ohio River). Suttner was billed as being from the popcorn capital of Illinois, if not the world.

At any rate, Suttner was the first 7-footer in Kansas State history, although on a good day he might have weighed 180 pounds. Deep-voiced Rog discovered early that when the Big Eight basketball winds blew, he toppled over like corn rows in a Dyfonate commercial.

Remember, I said Winter was patient. The first thing he had to teach Suttner was how to walk backwards. In his first varsity game – some three seasons prior to the 1964 Final Four and against the roughhouse St. Louis Billikens – Roger went for a rebound and was deftly hipped into the two-bit seats at Kiel Auditorium. He promptly called time out and informed Winter rather apologetically: “Coach, I don’t think I’m ready yet.”

But three seasons later – after considerable patience on the part of Winter – Suttner was ready. He blended in rather well with the four other small-town guys. By the way, Kansas State’s sixth man was Gary Williams, the highly touted Peoria (Illinois) prep whiz who later would play collegiately at Abilene Christian and Oklahoma City.

So, the 1964 Final Four field was set. The semifinal pairings pitted Kansas State against UCLA and Michigan against Duke. Michigan might have been the tourney favorite had the Wolverines’ All-America selection Cazzie Russell not been out with an ankle injury. As it was, any of the four schools appeared to have a solid chance of winning the NCAA title.

For 33 minutes it appeared Kansas State’s small-town guys would make the championship game. They had big-city UCLA on the ropes and reeling, sporting a seven-point lead with about seven minutes to play.

But then it happened! The weather apparently had broken and a previously delayed flight carrying the UCLA pom pon girls had arrived in Kansas City. And their sudden emergence – sun-tanned California beauties enthusiastically waving pom pons – obviously captivated the crowd, disrupted Kansas State and served to charge up UCLA.

Needless to say, UCLA rallied to beat Kansas State and then went on to defeat Duke in the finals. This represented UCLA’s first NCAA basketball title, a feat the Bruins and fabled Coach John Wooden would repeat nine times in the next 11 seasons.

But as far as I am concerned, the credit shouldn’t go to Wooden and his players – some such as Walt Hazzard, Gail Goodrich and Keith Erickson, who would go on to become household names in the professional ranks.

The true credit for starting UCLA’s dynasty should go to the pom pon girls. Had they not arrived when they did, who knows? …maybe a kid named Lew Alcindor (now Kareem Abdul-Jabbar) from Power Memorial High School in New York might have favored the gently rolling hills of Manhattan in Northeastern Kansas, … or perhaps an academic giant like Duke.

This year’s Final Four will provide additional memories, and certainly add to the history of perhaps the truly greatest spectacle in sports.

But history also carries strange accounts. It is interesting to note this season that three of those Final Four teams that made it to Kansas City some 24 years ago were still hopeful for a return trip after this year’s tourney field had been trimmed to 16 possibilities. Michigan, Duke and Kansas State all had a chance for today’s return journey. Of the 1964 foursome, only UCLA – a school whose program has fallen on rather ordinary times of late – was not a part of this year’s 64-team bracket.

Maybe the Bruins should be out recruiting pom pon girls!

Dialysis has its own pains and sufferings

I came across an interesting blog on www.madogre.com the other day that drew my attention, and it might help me in developing a total perspective on the topic of pain. The title of the writer’s post reads: “You don’t know Pain, until you know Gout Pain.”

His opening paragraph follows: “(Pain), it’s kind of like Gout. Dude, if you have never had a Gout attack, you have no idea what Gout is like. So don’t even think you know.”

In describing the pain, the writer points out that “when the weight of a light bed sheet on your foot is too much agony … when the pain keeps you up all night. I mean, Zero sleep because nothing touches, relieves, or does a dang thing to help the pain … .”

I have never experienced having gout, or a gout attack. But I can tell you there are enough pains and sufferings for those of us who are on dialysis, the end stage of renal disease. Like mentioned on www.madogre.com regarding gout, if you have never been hooked up to a machine that methodically circulates your blood for 3½-4 hours a day (three treatment sessions a week), then you may not have a realistic view of what someone on dialysis is experiencing.

Chronic kidney patients on dialysis are often confronted with sufferings of various kinds. For example:

** Physical pain – actual aches and pains within the body due to chronic kidney disease, and/or those sufferings that can be attributed to other medical concerns, such as heart disease, obesity, diabetes and hypertension, just to name a few.

** Mental pain – worries that painfully can affect the person’s mindset and, at times, cause ongoing stress and perhaps unending sleep apnea.

** Emotional pain – public episodes that might produce embarrassing reactions brought on by medical treatments, medicinal side effects, or blood pressure and/or blood sugar readings that are out of balance.

** Financial pain – dollars & cents matters that painfully can affect the pocketbook.

** Family pain – circumstances that painfully can affect not only the person on dialysis   but oftentimes the relationships with family members, extended relatives, neighbors and friends.

** Religious pain – Sometimes, as a result of intertwined pains and extended sufferings, patients on dialysis might reach a low point of questioning their faith, whether it be Bahá’í Faith, Buddhism, Christianity, Hinduism, Islam or many other religions of the world.

In experiencing the sufferings associated with dialysis, I can vouch for such pains in most every category listed above.

Physical sufferings on my part really had begun several weeks ahead of being placed on dialysis. A sudden, unexpected weight gain had put me over 200 pounds on the bathroom scales, and suddenly the smothering of internal organs (heart, lung, etc.) due to excess fluid had created a lack of stamina and a shortness of breath, both accompanied with an element of pain and suffering.

The stamina and breathing issues came to a climax in January of 2017, when my wife Maureen and I returned home from a weekend in Florida to watch three grandchildren play youth basketball on a Saturday afternoon, and to visit with daughter Sara and her family in Jacksonville. While it was fun watching the three games, it was burdensome for me to sit at length on the aluminum bleachers; at times I would stand up and lean on a structure pole within view of the court. The next day we returned to Indianapolis on a 90-minute flight. I had trouble exiting the chute from the plane into the terminal and required a wheel chair to reach our ride parked at the airport curb.

After starting dialysis treatments on February 1 of 2017, I soon learned about the possibility of cramping up during the process. While only slight, the cramping in my feet and calf areas was quite painful and generally eased by the attending technicians in short order. Mostly, leg cramps while on dialysis result from the following conditions: 1. When blood pressure is lowered quickly, 2. Due to rapid sodium removal, 3. The appearance as a clinical manifestation of low potassium level, and/or 4. Inaccurate fluid removal goal established prior to the start of a treatment session.

When cramping occurs, nurses and technicians can make adjustments that likely will alleviate the pain and the session can continue through completion. If the adjustments do not stop the cramping, then the dialysis process can be halted prematurely.

My second week on dialysis brought about what developed for a neophyte dialysis patient into a catastrophic and somewhat traumatic experience. Certainly, it was not what you would call a “warm welcome” to a new lifestyle.

On the Monday session, I began feeling quite colder as the treatment went on, despite sitting in a heated chair and wrapped up in a sweater and two blankets. Eventually the chills began alternating with an occasional bout of profuse sweating. I left the treatment center, went straight home and immediately sprawled out on the living room couch covered by a blanket. I stayed there until sometime in the night when I moved upstairs to another sofa, where I remained for all of Tuesday and until the time to return to the dialysis center for the Wednesday treatment.

That mid-week hook-up to the dialysis machine was not any more inviting than the one two days before. The chills prevailed once again, only this time noticeable shakes could be characterized more as uncontrollable tremors. About halfway through the treatment, my temperature reached 102 degrees; my wife was notified that it might be wise to take me to the hospital following treatment. However, before she arrived at the center, the temperature had climbed to 104, and clinic personnel already had summoned an ambulance, noticing that I was in a rather hallucinating state.

At the hospital emergency room, I was diagnosed with sepsis and eventually admitted. The doctors determined that my access ports located high up on my right chest for facilitating dialysis were infected. I stayed in the hospital for about a week while antibiotics eliminated the sepsis and a new catheter connecting to the jugular vein was implanted once again.

Needless to say, the introduction to dialysis to this point had already brought on some physical-type pains, not to mention the many painful thoughts that had an effect on my mindset, emotions and family considerations. There were those sleepless nights where thought processes were stressed out to the limit, emotions were challenged, and considerations as to how family members would adapt to the new lifestyle changes I was being forced to live.

The most physical pain and suffering for me came in the second month (March) on dialysis when one of my new medications – Calcium Acetate, known as Phoslo – became quite problematic. One of its many side effects is constipation. Within two weeks, I met up with this big blue pill that is designed to prevent high blood phosphate levels in patients on dialysis due to severe kidney disease. The original dosage called for taking about 35 such pills weekly, and soon the prescription was upped to twice as many.

I never got to increasing the dosage. It soon became quite evident that the pills would unleash the one side effect – that would provide me with some tales that should not be told at the dinner table. Early in my transition to dialysis, I began researching and writing a book that was published in late 2017 that was titled Dialing in on DI-AL-Y-SIS. Chapter 7 (GUESS WHAT NEW MONTH BLEW IN?) documents the two rather personal bouts with Phoslo, the first in my ground-floor bathroom at my condo and the other at the Emergency Room at Community Hospital South. Soon thereafter, my nephrologist dropped that medication from my pillbox list.

Note: Those wanting to read the entire details of Chapter 7, or might be curious about the other 15 chapters of the 174-page book, the quality paperback is available online at www.diodialysis.com or at www.amazon.com.

There was one evening during the early weeks of my being on dialysis that my wife was out of town and unable to pick me up after my treatment. At that time, my dialysis sessions were late in the afternoon. Good friend Jerry Lantz stepped up to handle chauffeur duties, and we planned on eating out.

When he pulled up to the pick-up site next to the center’s main entrance, I walked out and got into the passenger seat. He pulled out of the drive and while entering Madison Avenue on the south side of Indianapolis, he asked me where I wanted to eat. I started to reply, but somehow, painfully, I couldn’t reply.

What an embarrassing moment and more. I knew where I wanted to go eat, but I couldn’t get it out. My lips and mouth were moving, but I just couldn’t get my voice to work. Jerry quickly noticed I was having a major problem with my speech and suggested we get something to go so I wouldn’t have to get out of his vehicle. We settled on a Subway sandwich shop, and with some prying he got the word “tuna” out of me. We went on to my condo where I was still having difficulty with my speech and began eating our sandwiches. In 20 minutes or so my speech slowly returned to somewhat normal and my son Evin showed up to stay the night with me. That would wind up being an account that I can definitely document as having suffered an embarrassment.

Some public episodes have been more embarrassing. I have over the years passed out due to equilibrium issues on several occasions – once conveniently at a funeral home showing, another time at my urologist’s office, and again at a Bob Evans restaurant in New Castle while in between games at the annual boys’ basketball holiday classic. The latter experience was quite painful; when I woke up I was lying on the restaurant floor exchanging stares with eaters while I was being loaded onto an ambulance gurney for treatment in the parking lot. After being tested for blood pressure and blood sugar readings and invited to be taken to a New Castle hospital, I decided to return to the restaurant to eat the lunch that I had already ordered. I also went back to the country’s largest high school gym for the night-time game.

For many, if not most, end stage renal disease patients begin their journey on dialysis in a mental state of denial. “Why me? I really don’t believe this is happening.” It is at this point where some patients may begin to question their spiritual faith. I can admit that my mental state and my emotional being was being challenged.

Before my initial dialysis treatment, I threw a one-night “pity party” with no invited guests. I spent an entire night tossing and turning in a hospital bed ahead of my first-ever time to be tethered to this rather imposing, blood-circulating machine, searching for a way out of doing something I truly totally didn’t understand and truly totally didn’t want to do. As the sun slowly prefaced a new day, the party came to a halt and I ended up doing what I truly totally did not want to do.

That was more than a year ago. Since that beat-down by Phoslo, any pains and sufferings have subsided for the most part, thanks to a great extent to having completed the therapeutic exercise of researching and writing the book Dialing in on DI-AL-Y-SIS, documenting my experiences and overall perspective of being on dialysis.

What bothers me now more than anything is directly witnessing three days each week the ongoing pains and sufferings – whether it be physical, mental, emotional, financial, family or religious – that are endured by fellow patients. What my mind wrestles with almost daily is trying to transition a multi-faceted vision into a realistic and worthwhile project that will help alleviate some of these pains and sufferings. Stay tuned.

 

Wearable artificial kidney could be ‘game-changer’

In a chapter of my book Dialing in on DI-AL-Y-SIS (released in November of 2017), I made mention in a chapter titled Perhaps There Is Hope Ahead that research involving Dr. Jonathan Himmelfarb is working on developing a wearable artificial kidney.

Dr. Himmelfarb is the director of the Kidney Research Institute & Joseph W. Eschbach Endowed Chair in Kidney Research at the University of Washington School of Medicine in Seattle. An update on the progress of his team’s research suggests that the wearable artificial kidney project could reach clinical trials by 2022.

The following account sheds the light on the status of the research effort that hopefully will someday become a game-changer for many patients who are on dialysis today, and many others who will someday wind up as end stage renal disease patients.

By Omar Ford, Managing Editor

Medical Device Business

(Posted online February 8, 2018)

Most innovations medicine occur by asking one simple question. Is there a better way? Physicians at the Kidney Research Institute of the University of Washington have asked that question about hemodialysis treatments – lengthy procedures that filter a patient’s blood when the kidneys no longer function properly.

The institute is developing a wearable artificial kidney that could completely change the paradigm for some of these patients with impaired kidney function.

Earlier this week at MD & M West, Dr. Jonathan Himmelfarb, director of the Kidney Research Institute, spoke about the development of the artificial kidney and gave a timetable on when such a technology could be up for review by the FDA.

“There has been an increase in the number of people with kidney failure who were treated particularly with dialysis and particularly with hemodialysis,” Himmelfarb said. “Now there are about 600,000 people in the United States today in which the vast majority – close to 500,000 – are treated at dialysis centers.”

Typically, these patients go to dialysis three times a week with a four-hour treatment. These treatments have significant impact on lifestyle, but even more than that the mortality and morbidity of these patients is very high.

“The average person, even today, who starts dialysis will survive for about three to four years,” Himmelfarb said. “The mortality is about 20 percent per year. With what we provide for dialysis function today, we don’t really restore kidney health.”

In 2012, the FDA issued out a challenge to innovators to develop a technology to address kidney failure patients.

The Kidney Research Institute submitted an application to the FDA, and was one of three chosen out of 32 applicants to move forward with the development of an artificial kidney. The Institute conducted an initial trial in Seattle.

The wearable artificial kidney is a 10-pound, battery-powered device worn on a belt that provides around-the-clock, continuous dialysis.

“A lot of the components will work like dialysis does today,” Himmelfarb explained. “You take blood out of the body and you circulate it across a membrane that allows certain toxins to move to the other side of the membrane. You drop them on the other side and the blood goes back into the patient. That’s the basic concept of hemodialysis, and that will be the same [for the device].”

An early trial of a prototype of the device showed that five out of seven patients completed the full 24 hours of treatment. Two others had to stop participation in the trial because of technical issues with the device. The treated patients were able to walk in the hospital’s halls while the device continuously cleaned their blood.

Himmelfarb said the Institute’s goal is to take a more refined version of the wearable artificial kidney to take through clinical trials in 2022. He said a commercial vehicle to market such a device hasn’t been established yet.

“First, we have to generate all of the intellectual property and then we’ll eventually develop a commercialization strategy,” he said. “But right now, we’re focused on the science of trying to make this work.”

Why we must not let newspapers disappear

While whiling away time on dialysis, I at times as a retired journalist run across some humorous items on the Internet. This recent finding makes you wonder how some readers never get past the headline. Click on link.Why We Must Not Let Newspapers Disappear

Greeley said ‘Go West’ — I decided to ‘Go North’

It is often thought that “the grass is always greener on the other side of the (pick one: fence, hill, road, wall, or whatever).” It’s a thought so much stated that the time-worn bromide is among “the 50 most important proverbs” as listed online by phrasemix.com.

After completing one year of in-center dialysis at the end of this past January, I found myself contemplating whether a fresh medical evaluation might be in the best interest of assessing my mortality. In other words, what are the possibilities looking ahead? And what is available ongoing that I as an end stage renal disease patient can control?

Being a retired journalist, it is appropriate that a phrase often credited to the American author and newspaper editor Horace Greeley crossed my mind: “Go West, young man, and grow up with the country.” Of course, I am no longer anywhere near being a young man, and I have no intention of subscribing to that popular concept of the mid-1800s known as the Manifest Destiny, a widely held belief in the United States that its settlers were destined to expand across North America.

What has become prevalent nowadays, though, is what many patients face in dealing with a current chronic disease, and perhaps with an impending surgical procedure. Often, after they get the original prognosis, they seek a second opinion. Or maybe a third. And often what falls on patients’ ears at each stop are the same old lines of embarkment. This is the treatment you need; this is the protocol for what needs to be done. And in many cases, it needs to be done right away.

For those who have reached the final stage of kidney disease, the options for treatment in the Western civilization are pretty much set in stone – go on dialysis for the rest of your life, … or receive a kidney transplant. Neither are all that inviting, although those are the methods available in this country for prolonging your existence.

Also, among my several thoughts were those gleaned from Indiana author Mark Montieth, a familiar sports writer and television/radio personality. I have known of Montieth for some years but only met him face-to-face once. A few years back, Mark had the gumption to defy traditional Western civilization treatment in coping with squamous cell carcinoma, a cancer which began with a tumor on his tonsils and spread to his lymph nodes. According to his story – which is documented on his markmontieth.com website – the cancer was the result of a virus, HPV 16.

Montieth’s parents and older brother have owned a natural food store, Georgetown Market, on Indy’s northwest side since 1973. What Mark had heard from one doctor after another was needed in treating his disease didn’t set quite right with his upbringing.

In one portion of his online account, Montieth writes: “I know of and believe in the world of natural ‘medicine,’ and have always believed instinctively the body usually can heal itself with the proper nutrients. I also believe traditional medicine is mostly a corporate, profit-motivated enterprise, filled with some great minds and good-hearted people but also no shortage of brainwashed money-grubbers who care more about their bank accounts than their patients. It requires massive overhead to keep all those high-tech cancer centers operating, and the only way for them to do it is with the income from chemo and radiation treatments. A ‘cure’ might shut them all down and put thousands of people out of work.”

What Montieth ultimately did was sidestep traditional medicine, deciding to follow as natural a path as possible. That included some local holistic treatment sessions and consultations from outside the United States (and outside Indiana). In the long run, this stubborn and determined warrior beat his cancer, and offers a compelling account of his journey.

I certainly don’t have the background in natural healing that Montieth has. However, I did encounter – through research while writing a recent book titled Dialing in on DI-AL-Y-SIS – an interesting Australian fellow by the name of Duncan Capicchiano. For more than a dozen years, this certified naturopath has promoted a program known as The Kidney Disease Solution. The program, according to his website beatkidneydisease.com, is a complete and holistic approach to regaining kidney function and for living a normal healthy life.

I literally bought into his program and have been using many of the specifically created to fit the 80/20 ratio of alkalizing/acidifying ingredients by volume required during the restorative phase of The Kidney Disease Solution treatment. I am convinced the material in his 130-page cookbook and kitchen companion guide was instrumental in helping me attain consistent monthly lab results and satisfactory daily weight readings.    

After weighing in on a mixture of the English proverb, the Horace Greeley suggestion, and the Mark Montieth testimonial on beating cancer, my thoughts finally crystallized into a decision on what to do about obtaining a fresh evaluation on my mortality. While not necessarily expecting greener pastures, nor hankering to “Go West,” I did decide to transition to a different treatment facility on the south side of Indianapolis.That entailed being accepted by a newly certified Fresenius Dialysis Care operation and “Going North” about a mile to near the corner of Southport Road and South Madison Avenue. My first session was on Valentine’s Day (February 14), and my new starting time aligns with the roosters at 6 o’clock in the morning on Mondays, Wednesdays, and Fridays.

I do acknowledge being somewhat comfortable in recognizing that the past half dozen months or so have been rather consistent when assessing lab work. And I have been “feeling fine,” too. However, my sales background tells me that status quo is not good enough. A successful sales organization relishes a gain in production; otherwise, there is the perspective of falling behind.

So far, on perhaps the greener side at the Fresenius center are the individual patient TV sets that include some sports channels. And hopefully looming ahead is a fresh evaluation of my current and likely future on or off dialysis.  As legendary baseball pitcher Satchel Paige once said: “Don’t look back. Something may be gaining on you.”

Maintain hope in research while coping with dialysis

While coping with the day-to-day life of being on dialysis, I keep my chin up by following the progression of Kidney Project, a research effort that lends hope to the thousands upon thousands of us tethered with end stage renal disease.

Just how much hope that someday many of us may be able to rid ourselves of dialysis altogether is yet to be determined. Any hope at all for many of us, though, makes treatment days at a mundane dialysis center that more tolerable.

For now, the measure of this hope is in the hands of those who are working in collaboration to create an implantable bioartificial kidney that likely will alter the lives of ESRD patients. When the day comes that turns hope into reality will no doubt vastly impact the renal disease industry.

In my recent book – Dialing in on DI-AL-Y-SIS – I devoted a chapter toward several areas beyond current traditional treatment options that might provide needed hope for renal disease patients. Kidney Project was one research effort that offered some in-depth information.

Until that time comes when an implantable artificial kidney truly becomes a reality, there is a place to go on the internet for timely updates – www.facebook.com/ArtificialKidney. A most recent posting (January 30) reports on the status of Kidney Project’s preclinical testing. It states:

“The Kidney Project is (in the midst of) transitioning out of preclinical testing for the Hemofilter, while preclinical testing for the Bioreactor is underway. Results from preclinical testing of the Hemofilter are encouraging. We have successfully implanted the Hemofilter component into large animal models for up to 1 month. The animals responded well, without serious complications. We have collected enough preclinical data to apply for our first clinical trial and are waiting for approval for our first application.”

A post a week earlier addressed how the bioartificial kidney device works, and how big the device really is.

“The bioartificial kidney, the size of a coffee cup, consists of two modules that work together to get rid of wastes. First, a hemofilter module processes incoming blood to create a watery ultrafiltrate that contains dissolved toxins as well as sugars and salts. Second, a bioreactor of kidney cells processes the ultrafiltrate and sends the sugars and salts back into the blood. In the process, water is also reabsorbed back into the body, concentrating the ultrafiltrate into “urine,” which will be directed to the bladder for excretion.”

In May of 2017, the project’s two front-line doctors – Dr. Shuvo Roy of University at California San Francisco and William Fissell at Vanderbilt University – were quoted on how the success of Kidney Project can carry such an impact.

Said Dr. Roy: “Our goal is to eliminate the burdens of dialysis by providing an implantable device that provides both the clearance and biological functions of a kidney.”

Stated Dr. Fissell: “The project is about creating a permanent solution to the scarcity problem in organ transplantation. We are increasing the options for people with chronic kidney disease who would otherwise be forced into dialysis.”

Whenever the hope of Kidney Project becomes a reality, the materialization of such a breakthrough has been promised help by the U.S. Food & Drug Administration. The FDA has selected Kidney Project to a new regulatory approval program called Expedited Access Pathway. EAP is intended to bring breakthrough medical device technologies to patients faster and more efficiently.

From the viewpoint of we treatment patients, Kidney Project success can come as soon as tomorrow.

End Nearing for 1st Year on Dialysis

This very cold month of January (2018) will conclude my first year of being on dialysis.

I am not looking at month’s end as a time for celebration; there are no plans for a party in behalf of surviving one year in partnering with Count Dracula, the name I have given my dialysis machine. Rather, I consider the month’s end as more of one as recognition – a time to acknowledge that my life likely has been prolonged. And done so by a process that three times a week circulates the 10 or 11 pints of my blood, while methodically filtering it each treatment day (about three complete cycles) in removing any excess fluid and cleansing the bloodstream of any bad-boy toxins.

As a result, I generally feel pretty good going into and coming out of dialysis, along with the time in between. Maybe that is reason for celebration.

What I do savor about the past 12 months are the conversations with fellow end stage renal disease patients, and several of the people who I have become acquainted with in doing research for my new book titled Dialing in on DI-AL-Y-SIS and some others who fall into the category of book writers. Among the latter are World Series baseball champion Ed Hearn, University of Cincinnati professor emerita Angelene J. Hall, and noted kidney disease advocate Jim Dineen.

** I have known of Ed Hearn since he was a member of the 1986 World Series champion New York Mets, and soon after involved in a trade that took him to the Kansas City Royals, my favorite team ever since the team’s inception in 1969.

Hearn, whose lengthy Minor League run (eight seasons) but very brief Major League stint was shortened by injuries, was featured in a chapter of my book. Following his baseball career, he endured medical struggles with several very serious diseases – chronic renal disease that forced him through years on dialysis followed by three kidney transplants, a life-threatening sleep disorder, and battles with carcinoma, a type of cancer that requires radiation and a multitude of prescribed pills.

The Florida-born Hearn in 1996 wrote a book titled Conquering Life’s Curves that I discovered while researching my book. I ordered a copy of Ed’s hardcover offering and found it to be an uplifting find. It took me only one overnight read to finish it, and soon thereafter I enjoyed a memorable telephone chat with him, the first kidney transplant recipient I had ever indulged in conversation.

In the past couple of decades, Hearn has become one of the top 10 inspirational speakers in the country.

** I came to know of Angelene J. Hall just this past holiday season when my second-oldest daughter, Erin Gilmer, provided me with a book receipt in a festive bag beneath our modest window-box tree. The thoughtful reading titled Duck Summer was en route, arriving a few moons after Christmas Day. Angelene’s interesting book chronicles her six-year odyssey on dialysis that preceded her eventual kidney transplant in 2004.

After reading Hall’s book, I was able to connect with her by telephone. She still resides in Cincinnati, and Summer Duck, her most recent literary writing, represents her efforts in using her experiences with ESRD to educate the public about renal decline and ultimate failure, dialysis treatment, and the urgency of organ donation.

** Even more recently, I have had an occasion to hook up through Facebook and by email with dialysis patient/kidney transplant recipient Jim Dineen. The West Chester (Ohio) former steel industry manager penned a poem titled Those Who Go, Those Who Stay that appears in my book as a very appropriate presentation.

Jim wrote the poem in 1990, when someone asked him about his experiences during the Vietnam War. His daughter, Shari, then painted a picture for him using his poem as her inspiration. The picture has the same title and depicts a Vietnam veteran kneeling at “The Wall” memorial in Washington, D.C.

Dineen was diagnosed with kidney failure in 1998. After three years on dialysis, he received a kidney in November of 2003 from Joyce, his wife of more than 40 years. In June of 2004, their story was featured in Readers Digest, focusing on how kidney disease dramatically affected their family and brought them together.

In addition to his poetic prowess, Dineen has authored two books – one titled Life’s Just Not That Complicated and another titled Stand Up, SPEAK! He also since his transplant has dedicated hours upon hours of time and effort as a spokesman for kidney disease at various levels of advocacy.

Though Dineen’s poem originally was written with a specific subject in mind, the words, according to the author himself, “also ring true for everyone, and especially for those of us with kidney disease.”

Dineen’s poem – Those Who Go, Those Who Stay – appears in Dialing in on DI-AL-Y-SIS as follows:

Those Who Go, Those Who Stay

 By Jim Dineen (dialysis patient, transplant recipient)

 If time were a day, or a week, or a year,

and friends were the fluid that creates a tear;

Then life for me continues a dream ….

Bear with me a moment, here’s what I mean.

 

I’ve lost a few throughout my life,

Some ’cause natural, others ’cause strife;

And through it all some things remain …

Life’s really not cruel, it just has some pain.

 

 When we rise each morning, sun shining or not,

Don’t think of who’s gone, but think of who’s not;

And give them respect and warmth and love

to get through their day on the wings of a dove,

Or maybe an eagle, an osprey’s wing …

Give them something to make their hearts sing.

 

You see, our friends, through life’s perils and strains,

are always ours, regardless of pain;

Always seeing the good, forgetting the bad,

that each of us shows whether happy or sad;

Whether times are good or sometimes hard,

they’re there for us, they’ll deal the card

That’s best for us when we’re in need …

No questions asked, simply planting the seed.

 

The end of this piece is nowhere to be found,

’cause just like our lives, it flows ’round and ’round;

New friends will come, and old ones will go,

But the ones we know best continue to show

The need for our presence, the need for our trust …

Look around you, my friends, those folks are us.

Are we splitting hairs on ideal body weight?

A post shared by noted Facebook kidney disease advocate James Myers caught my attention regarding Ideal Body Weight. Many dialysis patients such as myself take a serious approach to keeping our scale weight into the close vicinity of our dry weight. I know that I do on a daily basis.

My actual height is 5-feet, 8 1/2-inches. My scale weight has fluctuated between 164 pounds to 168 pounds over the past seven to eight months, ever since I was placed on dialysis on February 1 (2017).

The Ideal Body Weight chart has me, a male, using a midway point between 5-foot 8 and 5-foot 9, which would set my Ideal Body Weight at 157 pounds or 71.2 kilos.
My dry weight has been established by my treatment clinic doctors and staff at 76.5.

On many treatment day weigh-ins the scale reflects figures below the dry weight level; therefore, on many occasions Count Dracula (the dialysis machine) has little or no excess fluid to draw on. That leaves my three and one-half hours of treatment relegated to only circulating my blood in removing those bad-boy toxins.

On several occasions, nurses and technicians have suggested lowering the dry weight level, which likely would call for more frequent drawing of excessive liquids. I balk at that notion. Why? I perceive myself as being too skinny as it is. With the exception of the first six weeks of dialysis, when my scale weight of more than 200 pounds was brought down to 163 pounds, I have come to dialysis feeling good, and I leave dialysis feeling good. My monthly lab work consistently falls within the parameters desired by my dietician and by the Kidney School’s charts that provide an understanding of lab results. Even my heart doctor has encouragingly cleared me to resume playing tennis, when and if we ever enjoy much better outdoor weather.

So far, even the doctors at Premier Dialysis where I receive treatments three days a week, the lowering of my dry weight has become a mute topic. Since my stamina remains constant, evidenced by my wife (Maureen, the chauffeur) and I on occasion leaving my treatment center for a restaurant meal, or to walk the aisles at a grocery store for a basket full of sustenance.

Hopefully, I will discover that my stubbornness over lowering my dry weight is just a matter of splitting hairs. Or maybe I just need to grow a couple of inches while maintaining my current weight fluctuation.