Monday, December 28, 2009

My MS Story Chapter 24- Life’s Little Indignities

Small White butterfly (Pieris rapae)
(Photo credit: Wikipedia)
“Humility is the ability to give up your pride and still retain your dignity.”

- Vanna Bonta

In the spring of 2005 our company merged with one from the West Coast. We were both very profitable and fast growing entities, which meant that we could afford to pull together the entire group for a long weekend. This gathering was ostensibly for team building, bBut what I remember most about the weekend was the staggering amount of alcohol consumed.  I can't recommend a party weekend as the most economical or otherwise prudent way to bring two groups of people together to bond. But for this youthful crowd, it was a stroke of genius.  

On a Friday night in October of 2005, we descended upon Callaway Gardens, in Pine Mountain, Georgia. We arrived as two disparate groups who were very suspicious of one another, as we had been bitter competitors in our previous corporate lives. After the meeting we were at least drinking buddies, and that is saying something. I know there were a number of people- the responsible adults - who turned in early and did not participate in the revelry. But they were in the minority. Most people remember it as an epic weekend. Some people don’t remember much about it at all.

I was concerned about mobility issues that I might encounter at this retreat, so I spoke with the meeting coordinator a few weeks ahead of time. Callaway Gardens is a sprawling complex. Our cabins would be in one area; the meeting rooms would be another. We would be tackling outdoor activities in a completely separate corner of the complex. She assured me that my mobility issues were being taken into account. We decided that I would rent a scooter to use on some of the longer walks at the resort. It turned out that two other employees had also mentioned mobility issues, so I volunteered to coordinate the rental of three scooters for the weekend.

When we arrived at Callaway Gardens the scooters were waiting for us. Unfortunately, only two of them were operational. We did a quick assessment and decided that Margo and I needed them the most. Steve had a bad knee, but volunteered to tough it out.

The first evening of dining and drinking went well for me. The only problem was sleeping. We were allowed to choose our own roommates if we so desired. Jeff, my best work buddy, and I decided to room together. But I didn't know about his snoring problem. Man, can that guy cut the zzz’s! The first night of sleep was fitful, but I think the alcohol helped. On the second night I slept on the couch in the living room instead.

After breakfast on Saturday we were instructed to gather at the front of the main building to board buses that would take us to the other end of the resort for the day’s activities. Although I had been told that the buses could accommodate scooters, this was not the case. Being the troopers that we were, Margo and I said that we would just drive our scooters down the road and meet everybody at the destination.

We were handed maps, and instructed on where we would all meet for the group photo. Margo and I set out down the road in our scooters (these were private paved roads around the complex). Before long the buses passed us. People waved to us. I really shouldn’t have, but nevertheless I did feel conspicuous zipping along at 5 mph in my scooter while everybody else except Margo was merrily transported to the destination on buses, like normal people. But I didn't say anything. Let’s call this Indignity Number 1.

Then we literally came to a fork in the road. We chose the road “less travelled by” and it sure made all the difference. When we finally got to the end of the road, there was nobody there. I looked down the hill. I could see people unloading from the buses at the location we would have gone to if we had taken the road more travelled. I should probably stop making my directional decisions based on a Robert Frost poem.

It would have taken us a long time to backtrack to the fork in the road and correct our error. But I noticed a promising path that worked its way down the hill, in the general direction of the buses. Margo and I set out along the path in our three wheeled scooters. It turned out to be another bad move- frying pan into the fire. The path ended about halfway down the hill, and there we sat. We observed from a distance as the other 150 or so folks all posed for the group picture.

Today, this photo is a highly revered and sentimental reminder of that magical weekend. It is proof of who was present for the now legendary meeting, and who the original members of the merged company were. Only Margo, me, and a couple of people nursing their hangovers were missing. The photo still hangs in a special place at the office. I have little doubt that one day it will be displayed in the Smithsonian Museum, in Washington, D.C. The caption will read- “The Coolest Corporate Retreat Ever”. My future grandchildren will exchange knowing glances with one another when Grandpa tells them that he was actually there- just didn’t make the photo.  “Sure Grandpa, did you walk on the moon too?”  Nudge, nudge, chuckle, grin.

Little shit-heads.
Back at Callaway Gardens, some folks eventually took notice of our dilemma and walked up the hillside to help us out. Missing the group photo and being assisted down the hill were Indignity Numbers 2 and 2a.

We then broke into our scavenger hunt teams- maybe six or eight people per group. Our task was to find boxes that had been hidden at various locations. I set out with my group in search of our boxes. It quickly became obvious to me that the boxes weren't hidden in the middle of the road, so I couldn't really be of much help in my scooter. I retired prematurely (hmm, is there a pattern here?) to the location where we were supposed to meet at the end of the scavenger hunt. Also present were twisted-ankle-guy, way-too-hung-over-guy, and eventually Margo. Not being able to help my team out in the scavenger hunt was Indignity Number 3.
After the conclusion of the scavenger hunt we were given the afternoon off to explore whatever part of Callaway Gardens we were interested in. Margo and I, and a few others, decided to visit the Butterfly Conservatory and an exhibit of live birds of prey. This was very interesting stuff. I give Callaway Gardens high marks as a destination for these types of meetings. .

Eventually it was time to return to our cabins and prepare for dinner. There were shuttle buses running, so Margo and I told our walking friends to just grab a shuttle and we would catch up with them at dinner.

With maps in hand, we set out for home in our scooters. Very soon, though, we both realized that we were running dangerously low on battery power. When we were just outside Margo’s cabin, her scooter died. Mine still had a little power, so I maneuvered it behind Margo, and pushed her and her scooter the last 50 feet or so into her cabin. I'll refer to this as Indignity Number 4.

We both charged our batteries and had no more mobility problems that weekend- no more indignities.

I've become accustomed to suffering various public indignities like I did that weekend. It's just part of my life now. I would be lying if I said that my self confidence is so highly developed that these situations no longer bother me, but I am improving all the time.

When I end up in a mobility predicament, which I occasionally do because I refuse to make my home into a cocoon, my situation may appear pathetic to the casual observer. But it’s only pathetic if I take myself too seriously.

As Vanna Bonta suggests in her quote at the top of this post, I’ve found that exercising a certain amount of humility is the best tool for surviving life’s little indignities.
Enhanced by Zemanta

Thursday, December 24, 2009

A Touching Music Video

Click here to see this cool video I found at Stu's Views & M.S. News.

It makes you think.

Wednesday, December 23, 2009

My MS Story Chapter 23- There is life, and more Rituxan, after the trial.

(Photo credit: bfishadow)
I asked my local neurologist to set me up with $10,000 worth of the good stuff. This was a tremendous amount of money for me to spend for two infusions of Rituxan, each weighing only one gram, but I decided it was worth it.

Then I got some bad news. My information on the cost of Rituxan was wrong, by a factor of two. The amount was actually $20,000 for a pair of infusions, not $10,000. For me, this changed everything.  The extra $10,000 was the difference between feasible and not feasible, go and no go. Crap!

We moved on to plan B, or was it C? I lose track. We needed to make our case with the insurance company.  They should pay for the infusions, because I had proof that this treatment was very effective for me, whether or not it would work for the more general PPMS population. Maybe the phrase “make our case” is too soft. We were preparing to “go to war” with the insurance company.

Gun CrewThen the strangest thing happened. The battle that we were preparing for did not occur. Without a shot being fired, my insurance company pre-approved a pair of Rituxan infusions.  No questions asked. No data required. Undoubtedly, somebody at the insurance company screwed up. I suffered no moral dilemma though. If a clerk gave me five dollars too much change, then I would feel obligated to inform them of their error. But when an insurance company reimbursed me $20,000 for treatment that I desperately needed, even though I knew it was a mistake on their part, I followed the advice of the Steve Miller Band.  I took the money and ran.

We scheduled the infusions for August 22 and September 5, 2007. I would receive the IV in my own town, instead of two hours away in Worcester. These infusions would be 20 weeks later than they should have been if I had stayed on the trial schedule. I had wasted almost half a year in this process. After the infusions I waited to determine if Rituxan would once again stop or at least slow down my progression.

These two Rituxan infusions created a new problem. My commitment when I started the trial was that I would not take any out-of-trial treatments for my MS. Doing so would understandably corrupt their data. These two infusions of Rituxan were definitely out-of-trial, so I was informed that I had to withdraw 3 months before the finish line. At this point the trial was providing no benefit for me. That was a non-issue. But I was officially a quitter- something Mom and Dad and the President and Jesus told me I shouldn’t be. Despite the legitimate justifications for my decision, I was still disappointed that I didn’t finish.

I had my exit interview and examination with Peter. His final assessment reconfirmed significant disease progression beginning about six months after my last Rituxan trial infusion. We parted on good terms. Peter understood that I was simply doing what I had to do.

In a clinical trial, the doctors and nurses who administer the trial protocol on behalf of those nameless, faceless administrators are put in a difficult position. All of these clinicians, or at least folks like those I worked with at UMass Memorial Hospital, chose their career paths in part because they possessed the quality of empathy. As a requirement of their jobs, they listened to patients’ concerns, consulted with them about the best solutions, and shared emotionally in their success or failure. Medical professionals certainly must be careful of becoming too caught up in the lives of their patients, but these people are not robots. They are caring and thoughtful human beings.

But in a clinical trial environment these caring and thoughtful human beings are no longer allowed to consider empathy in their treatment decisions. They still care about their patients, but it doesn’t matter.  There is a protocol after all.

It's a perverse system. I'm not saying that I’ll never participate in another clinical trial, and I'm not advising other people to avoid clinical trials.  But if I ever do participate in another one I'll go in with my eyes wide open.

Although I try to be an understanding and forgiving person, I do harbor resentment towards my Rituxan clinical trial.  It didn't care that I was getting better on Rituxan. It didn't care that this was the first drug that had ever shown any hope for me. It didn't care that when the trial drug was withheld from me I started to suffer permanent, irreversible damage to my central nervous system. It didn't care about anything. But it wasn't the clinical trial’s job to care about its patients, other than to do them no direct harm. This cool detachment was possible because the trial’s administrators made sure to never look me in the eye, shake my hand, or even hear my voice. If the goal is to keep patients and scientists separated, physically and emotionally, our country’s standard clinical trial protocol is highly effective.

We don’t bother to keep scientists and their lab rats separated in this way, only scientists and their human subjects. I suppose, however, that there is less risk of lab rats eliciting unwelcome empathy from their researchers.

OK, I’ve beaten this dead horse enough.  Next week we’ll move on to some new subjects.

For the final installment in the series, click here.
Enhanced by Zemanta

Thursday, December 17, 2009

My MS Story Chapter 22- Clinical Trial Endgame

Image via Wikipedia
I want to be clear.  I never met the people who screwed me over in this trial. I don't know their names. I don't know what they look like. I just know they screwed me over.

The people that I dealt with personally, the doctors and nurses and technicians, were all wonderful people. They just weren't holding the cards. Neither was I.

For some background on my experiences with this clinical trial, please read my previous posts:

MY MS Story #14- All in the Name of Science
My MS Story #16- The Clinical Trial Begins
My MS Story #17- There Will be Blood
My MS Story #19- Measuring the Immeasurable
My MS Story #21- A good friend turns into a coldhearted sonofabitch.

In the two extreme cases of a clinical trial, the endgame is straightforward. Often times it is clear even before the scheduled completion date of a clinical trial that the treatment is either not working or is actually doing some harm. In those cases the trial is stopped early or simply considered a failure at its conclusion. Everybody just packs up and goes home. Nice try. Good effort. We’ll get ‘em next time! This is not what happened in my trial.

On rare occasions a clinical trial may be a rousing success- high fives all around. When this happens sometimes the participants continue with the treatment in what is called an open label phase. After all, it would be cruel to just snatch a miracle drug away from long suffering patients who are finally getting relief, wouldn’t it? Plus, this gives the trial sponsors, usually the drug company, an opportunity to continue studying the long term effects of the treatment. This is how the trials worked out for several of the RRMS drugs that currently have FDA approval. I was hopeful that my trial would fall into this category, but it didn’t.

My trial endgame was in limbo. It was not an abject failure. It was not a rousing success. So there was no clear path forward.

I expressed an interest to my trial physician, Peter, about continuing with Rituxan infusions after the scheduled completion of the trial, but how? Peter indicated that he would be going to a conference of the trial doctors in a few weeks, and would let me know what he learned. We naively assumed that timely and compassionate decisions would be forthcoming.

For me the formula was simple. MS bad. Rituxan good. Must have more Rituxan.

I worked two parallel paths. I was hopeful that Peter would learn of an open label phase to the trial. But at the same time I was consulting with my local neurologist about setting up Rituxan treatment outside of the trial. Since Rituxan was not approved for MS, it seemed unlikely that my insurance company would cover it. I assumed the cost to be $5,000 per infusion, for an annual cost of $20,000.

I had my last two trial infusions of Rituxan in November of 2006. Like all the previous infusions, it went well. I felt that if I did not get another pair of infusions six months later then the effect of the Rituxan treatment would wear off, and my disease progression would return to the pre-trial rate.

The trial plan called for continued close tracking of the patients for a period of one year after their final infusion. The trusting soul in me assumed that this plan existed so that doctors could monitor for and react to any negative side effects. It was done, you know, for my safety.

The cynic in me believed otherwise. Perhaps this post-infusion period existed not for my benefit, but for the trial’s benefit, and by extension for the drug company’s benefit. Maybe the trial designers wanted to shore up their statistical case by demonstrating that two things occurred in the trial. People not only got better when they took the drug but also got worse again when they stopped taking the drug.

Had they even considered the possibility that in order to gather this information some group of trial participants, like me, would need to stop taking the only treatment that had ever worked for us?  I think it is easier for trial administrators to ignore these nuisance considerations when they have never met any of the patients face to face. Clinical trials permit nameless, faceless trial administrators to make medical decisions that would never be made by a compassionate physician treating a sick patient.

Probably it was a little of both- patient safety and data collection. I don’t mean to attack the trial administrators personally.  They are most likely decent people.  Our lovely system of approving new drugs is what elicits this heartless behavior from them.  

In April of 2007, about the time I would otherwise have received another pair of infusions, I had a routine appointment with Peter. I learned that the trial sponsor was still pouring over the data, and there was some hope of an open label study in…get this…January of 2008…maybe! That would be almost a year away, and well over a year after my last pair of infusions. I was not pleased with this information, because I expected that in the very near future my disease progression would resume with vigor (I was right). They were going to spend another year just watching and thinking and graphing and pondering! What amount of disability would I accumulate during that year? Nobody asked me.

Sure enough, almost on schedule, by July of 2007 I noticed that the disease progression had returned to the same rate it was at before the trial. I needed to get me some Rituxan.

I had another appointment in July with Peter. I shared with him my observations about the resumed disease progression. His testing confirmed it. For the first time ever, he measured a significant decline in my function, specifically my leg function. There was still no word from the drug company about an open label study. I told Peter that I might have to start Rituxan on my own, which would mean leaving the trial before its official conclusion. He understood.

I asked my local neurologist to set up a pair of infusions for me. I would pay the $10,000 cost out of pocket for these first two infusions. This wasn't an expense that I could easily support long term, but I just needed to bridge the gap until Rituxan got approved for treatment of MS, at which time my insurance company would take over the expenses.

Remember, with PPMS I'm not talking about symptoms that come and go. I'm talking about irreversible, permanent damage that was occurring slowly and steadily, like a Chinese water torture…drip, drip, drip. Every smidgen of disability that I have ever accumulated has remained with me. Given this reality, time was of the essence.

A one year wait for an open label study that may or may not materialize simply was not an option.

For the next installment in the series, click here.

Reblog this post [with Zemanta]

Sunday, December 13, 2009

Memories: Golf’s Cruelest Trick

Golf Green Island
(Photo credit: jurvetson)
My wife and I both agree that there were only three things in my life that ever really made me angry. Other than these tormentors, I have always been a pretty calm character.

First, there was my 20-year-old daughter. Well, she's 20 years old now, but she's not the one that drove me crazy. It was the teenage version of her that drove me crazy. She's grown into a fine young woman and we get along quite well now.

The second thing that drove me crazy was the play of my sports teams. Sometimes they did the stupidest things even though I'd instructed them, via yelling at them on the TV, to do otherwise. Why wouldn't they listen?

The third thing that drove me crazy was golf. Before I became disabled I was a decent athlete. I could run fast and jump high. I could hit and catch a ball, and make a basket. In high school I was a three sport athlete (football, basketball or indoor track, outdoor track). I also played a passable game of tennis and ping pong. After having a billiard table in my basement for a few years I could hold my own at pool. But golf? I could never understand that game, except one day a long time ago…

Our daughter Amy was born in May of 1989, well before my MS diagnosis. One Sunday morning that summer I took my turn with the 4:30 a.m. bottle feeding. I put Amy back in her crib at around 5:00 and prepared to return to bed myself. But I had just purchased a golf membership at the local 9-hole course, and it was a beautiful morning, so instead I quietly snuck out of the house and headed for the golf course.

When I got to the course nobody was there. The clubhouse was dark and quiet, but that was not a problem. The flags were in the holes and I had a membership, so I set out to play.

The first hole was a par four. I have no idea what I scored on it, but likely something well over par. The second hole was a 172 yard par three. I pulled out my 3 iron (this is evidence to any experienced golfer that I was a neophyte since the standard club for this length shot is more like a 5 iron, and Tiger would use an 8 iron if his wife is not chasing him with it). My tee shot went straight and rather low, as is standard for a well struck 3 iron.

The hole was cut just over a ridge in the green, so that I could not actually see the cup from the tee box. Most of the flag stick was visible, just not the last couple of inches and the cup itself. I was pleased with my shot because it appeared to have landed either close to the front of the green or on the green itself. I put my three iron back in my bag and trudged down the fairway.

As I approached the green I was a little disappointed. The ball was neither in front of the green nor on the green, so it must have run past the putting surface. There were some shrubs behind the green, and I started looking under those shrubs for my missing ball.

Then it happened. Remember, it was very early in the morning, just after sunrise, so there was still a heavy dew on the green. I stood there in disbelief as I noticed a curved track in the dew, running from the front of the green into the center of the cup, as clear as if it had been drawn by the finger of God himself. I shook my head in disbelief.

I approached the cup and dared to peer down into it. There was my ball. I had made a hole-in-one. Instinctively, I looked up and surveyed my surroundings in preparation for sharing this glorious moment with my fellow golfers. Let the congratulatory hand shaking and back slapping begin! But there was not another human being in sight. Well, that was not exactly correct. I could see the owner stirring up near the clubhouse. I left my golf bag beside the green and jogged up to where he was cleaning off the golf carts.

“Good morning, Jim.”

“Good morning, Mitch.”

“Jim, I have a problem.”

“What? Is it the mosquitoes?”

“No," I chuckled, “I just shot a hole-in-one and I have no witnesses. But I can prove it to you if you'll just come with me for a minute.”

We got in a golf cart and headed off for the second green.

For those of you who are not familiar with golf etiquette, holes-in-one really only count if they are witnessed. Otherwise any unscrupulous, attention-seeking hack could claim he hit one when nobody was watching. I was a hack, but I was of the scrupulous variety.

When we arrived at the second green I was pleased to see that the dew, and the evidence it possessed, was still intact. I told Jim my story and asked him if he believed me.

“I believe you Mitch.”

That didn't make my hole-in-one completely legitimate, but it was better than nothing. I never got another ace, witnessed or not, even though I golfed for about 15 more frustrating years.

In a sense this was the cruelest trick golf ever played on me, and it played some really cruel ones. To allow me a hole-in-one, but without a witnesses…ah, touché golf. Well played.

MS really sucks. But there are one or two silver linings. MS gets the credit for finally making me a quit a game that cost me too much money, caused me to spend too much time away from my family, and left me miserable more often than not. Unfortunately, MS took all those other sports away from me as well.

So as I mentioned above, my daughter no longer drives me crazy. Scratch that one off the list. My MS had made it impossible for me to continue golfing. Scratch that one too. What’s left?

If the Patriots and Red Sox can just win every game they play for the rest of my life…no, wait, that’s not enough…if the Patriots and Red Sox will never make even a minor mistake in any game they ever play for the rest of my life, then I’ll have nothing in this world that makes me angry.

(I’m aware of how well I just set up the Boston sports haters…have at it in the comments section, Louie).
Enhanced by Zemanta

Wednesday, December 9, 2009

My MS Story Chapter 21- A good friend turns into a cold hearted sonofabitch.

Progression types of Multiple sclerosis
Image via Wikipedia
There are two obstacles to finding a treatment for Primary Progressive Multiple Sclerosis (PPMS). First, it appears that nothing works. Second, even if something were to work, I doubt that the scientists would notice it.

Here’s the problem. With the more common form of MS, Relapsing Remitting Multiple Sclerosis (RRMS), there are some clinical measurements that correlate with disease activity: the number of enhancing lesions measured by MRI and the number of relapses experienced over a given period of time. Because people with PPMS don't have enhancing lesions and don't have relapses, all we are left with is trying to quantify the change in overall level of disability. This is accomplished by measuring patients’ ability to perform certain tasks, as I described in My MS Story #19.

It's much more challenging, from a statistical analysis point of view, to draw conclusions from these PPMS tests than from the RRMS tests. To make matters worse, I don't think they were even measuring the correct tasks during my trial.

When I was participating in the clinical trial I never had any vision or cognitive problems, so measuring those types of tasks was meaningless for me. I didn’t have any disability in my hands during the trial, so the test where I placed pegs in holes didn't yield any interesting results. The only part of my body that was affected at that time was my legs. Even then, the tests that they did on my legs didn’t actually measure what was wrong with them.

If I came to the doctor’s office using my scooter, so that my legs were not tired, I demonstrated near normal strength in all my leg muscles. I could walk across the examining room, albeit a bit like a drunk. That's how they tested me- always fresh and well rested (no, they didn’t test me drunk). However, at this point in my disease progression the defining characteristic of my disability was not how strong my legs were when I was well rested, but rather how quickly my leg strength deteriorated during exertion.

These are some of the reasons why I wonder if researchers would notice an effective treatment for PPMS, even if it was staring them in the face. PPMS progression is just so difficult to measure.

Throughout the trial my “official” performance data on the various tests indicated that the disease was no longer progressing. In fact, on good days, I was supposedly getting ever so slightly better. For the first year or so, I agreed with this assessment.

Unfortunately, in the summer of 2006, a little over a year into the two-year trial, I noticed that my legs were becoming fatigued more quickly than they used to. But still this change in my condition did not show up in the trial data. At work and at home I started using two crutches all the time, instead of sometimes one and sometimes two. I was just too unstable on one crutch. This indicated definite disease progression, but still at a much slower pace than before the trial.

At this point I had received three of my four courses of Rituxan (six of my eight infusions). In November of 2006 I was scheduled for my last pair of infusions. Both the doctor and I considered this trial to be a success for me personally. We’d have to wait a while to see if the larger population of trial participants also benefited. By his measures my progression had stopped. By my measures it had slowed down significantly. But either way, the trial had been worth it for me.  Naturally, I began to wonder about how to transition from getting Rituxan in the trial to getting Rituxan outside the trial, ideally without skipping a beat.

I was very pleased with my trial experience. The doctors, the staff, and the facilities were first rate.  I was lucky enough to be receiving the trial drug instead of the placebo (a correct assumption as it turned out). These clinical trials, I thought, are a good thing both for the participants and for medical science in general. The results, although imperfect, were much better than anything else I had ever tried. The trial had become like an old friend to me.  I didn’t want the relationship to end.

But soon enough I would learn that clinical trials can be an uncaring, coldhearted sonofabitch.

For the next installment in this series, click here.
Reblog this post [with Zemanta]

Saturday, December 5, 2009

My MS Story Chapter 20- Sometimes I am the predator. Sometimes I am the prey.

Young Bambi: What happened mother? Why did we all run?
Bambi's Mother: Man was in the forest.

I forbade my children to watch that movie. I was OK with more realistic films like The Wizard of Oz, Gremlins, or Willy Wonka and the Chocolate Factory.

Hunting is one of the many physical activities that has been limited by my disability, but it is a particularly significant one for me.

If you didn't know any better you might envision hunting as a bunch of heartless, drunken idiots wandering around the woods in orange clothing, carrying high-powered rifles. It's not your fault. These hunters do exist, and most television and movie writers (guardians of our culture) have chosen to paint us all with that broad brush.

For me, hunting is a family affair- more precisely, a male family affair. Sure, my mother and grandmother both dabbled in hunting a bit. I took my wife a couple of times. She actually shot a grouse once, but never showed much interest after that. This is what the men in our family do in the fall- my father and my two brothers. Our newest generation of hunters (my son and my 3 nephews) is batting .500. Two boys are interested in hunting and two are not. The times, they are a changin’.

We take our hunting seriously, and we work hard at it. It is an opportunity for us to catch up with one another- male bonding I suppose. There is a social aspect to it as well, sometimes involving alcohol. Getting drunk in the evenings was certainly more common when we were younger, back when we owned that hunting camp. Below is a photo of Andy with a deer in front of the camp. But we (almost) never allow the drinking to interfere with getting up early and going hunting, and we never have that first sip of alcohol until the guns are put away for the day.


Hunting provides me with a means for connecting to the land and to the many wonders of nature, and also to my ancestry and my heritage. In many ways the hunting that we do today is not all that different from the type of hunting that our forbearers pursued for the past couple of hundred years (power wheelchairs, ATV’s, and precision optical scopes aside). The primary difference is that if I am unsuccessful, which I often am, then my family won’t go hungry. Today we treat the land that we hunt on and the game that we pursue with respect. We were taught this by our father, who was taught by his father, who was taught by his father...

Now that the hunting season in Maine has ended for another year, this is an appropriate time for me to reflect upon and share with you how my hunting life has changed since my MS diagnosis.

The first two years of hunting with MS (fall of 2001 and 2002) were not hugely different from my healthy years. At that time I considered the changes in my walking ability and my hunting ability to be significant. These changes, however, were relatively mild compared to what would come later. I couldn't walk as far in the woods as I used to walk, but we still went to the same locations as we had always gone and employed the same hunting strategies we had always employed.

In the fall of 2003 I noted a significant drop-off in my hunting ability. I encountered a lot of difficulty walking in the woods because I couldn't easily lift my legs up over obstacles like stumps and logs and rocks. I was relegated to hunting in the open areas, such as logging roads and fields. I stumbled often and even fell a couple of times. That’s not a good thing when you are carrying a loaded gun.

I did have some success in 2003 though. We try to shoot bucks when we can, but late in the season if we have a doe permit (which, like a moose permit, is based on a lottery), then we will try to harvest a doe. My friend Dean and his father took me to a spot where they knew some does were hanging around. With just one day left in the season I was able to shoot a doe. I didn't know it at the time, but that would be the last deer I would shoot (to date). Below is a photo of me with the doe.

Copy of doe03

In October of 2004 I went on my first moose hunt. In Maine, hunters enter a lottery for the small number of moose hunting permits, and my name was finally drawn (the only moose permit I’ve ever won). This was my coming out week too- showing my cane to my extended family for the first time. On the second day of the hunt we came upon a mature bull moose, at a close range, and I didn't miss. Below is a photo of me with the bull. I wish we would've removed all of that cabling and rope lying on top of the bull’s body before we took the picture. We used an elaborate, field engineered cable and winch system to get this 750 lb (field dressed) bull out of the woods. Maybe somebody clever can Photoshop those cables away for me.


That same November I began to deer hunt from an all terrain vehicle (ATV) for the first time. The good news was that it allowed me to get around to a lot of locations in the woods that I couldn't have accessed otherwise. It certainly didn't allow me to venture deep in the woods where I used to hunt. Those days were gone forever. The bad news about deer hunting from an ATV was that it made a lot of noise and undoubtedly alerted the deer to my presence.

Although I could no longer walk in the woods, the bio-kinetics of my condition at the time still allowed me to safely climb a ladder into a tree stand, or so I convinced myself. Instead of being a stealthy ground hunter, I became an ATV and tree stand hunter. It was not ideal, but I still felt as if I was a legitimate hunter, and I could shoot a deer at any moment. Below is a picture I took from my tree stand.


Later that fall I was thrilled to have my son, Zach, shoot his first grouse at the advanced age of 12. He was getting a little old for his first hunting success, and I was growing concerned. What would people think if he became 13 or even 14 years old without his first kill? See the picture below.


Fall 2005, 2006, and 2007 were very similar to 2004 in terms of my hunting abilities. Instead of the cane I was using two forearm crutches. I fashioned a special holder on the ATV so that I could bring my crutches with me. I still managed to climb up into tree stands in ’05 and ’06, but got stuck halfway up the ladder in ’07, and so I grounded myself.

In the fall of 2008 I started to have some difficulty getting into and out of the ATV. One time I fell as I was trying to get off. That season was pretty much a bust for me. It rained a lot, and I just wasn't able to schedule much hunting time due to work conflicts. I owned my iBOT in the Fall of 2008, and planned to hunt from it, but that didn't really materialize. I harbored mixed feelings about the hunting season just completed, as well as my hunting future.

I recently finished up the Fall 2009 season, and again I didn't shoot anything. I mounted an ATV only once, and it was a major chore for my friend to boost me in and out of it. I was able to spend time hunting with my brothers, Andy and Tom, my two friends both named Mark, and a few other hunters who were very motivated to help me out. I know that any one of these folks would rather have seen me shoot a deer than shoot one themselves. That's just the kind of people I'm lucky enough to know.

I essentially gave up on the ATV idea and decided to hunt from my iBOT.  But I must say, this year I became re-energized about hunting.  I had an enjoyable season.

The iBOT has a four wheel drive mode, which allows me to go places a normal wheelchair would never go, but of course not as many places as the ATV allowed me. The iBOT, however, is pretty damn quiet compared to the ATV. I used a brace to hold up my gun and provide for a more steady aim, despite my weakening arms. I went deer hunting eight times this fall, usually for only part of the day.  I think it was just bad luck that I wasn't able to harvest a deer. On four of those hunts I went alone.

“What would you have done if you had shot a deer, alone?" asked my lovely and sensible wife.

“That's what cell phones are for,” I replied, knowing that my brothers and friends would have been more than happy to help me take care of a deer, if I had been so fortunate. 

I worry about how much longer I’ll be able to hunt, but I have an inspiration. A gentleman that I've met online, Don, is more disabled than I am and is still out there chasing deer. Check out his website at If you spend enough time at Don’s website you may come across a picture of me with my bull moose.

I always find the end of each hunting season to be somewhat emotional. As I gather up all the things and put them away for another 10 months, I reflect back on all the hours I just spent in the woods. I'm usually ready for each season to end though, because it's a lot of work and it's time to get back to other responsibilities. For me, the end of hunting season is a great segue into the Christmas season, which the child in me still thoroughly enjoys.

But last weekend, as I was putting away the hunting gear, I found myself pondering a question that I hope is premature, but I just can’t know for sure.

Was this hunting season my last?

Tuesday, December 1, 2009

A New Theory about the Root Cause of MS- Chronic Cerebrospinal Venous Insufficiency (CCSVI)

One of the frustrating realities of living with MS is that nobody has a clue as to its root cause. It’s hard to imagine that a cure is on the horizon when we don’t even understand why the disease exists. It seems that for the past 50 years neurologists have been telling newly diagnosed MS patients that the cure is “about 10 years away.” Sure it is.

There have been a lot of root cause theories presented over the years. None have survived the scrutiny of time and truth. This one probably won’t either, but who knows?

An Italian doctor by the name of Paolo Zamboni has discovered a correlation between MS and restricted flow in the veins that drain the central nervous system. Furthermore, he has used angioplasty to open up these restrictions in the veins of some MS patients, with apparent success. Dr. Michael Dake, of the Stanford School of Medicine, has been placing stents in the veins of MS patients, with similar success but also with more complications, a couple of them serious. Many patients of both doctors have stopped getting worse and started getting better.

Click here to watch an inspirational piece produced by CTV that does an excellent job of describing Dr. Zamboni’s CCSVI work. I find the tone of the piece a bit too optimistic, but again, who knows?

What is my take on CCSVI? I think the final answer will lie somewhere on a continuum between total fraud and a miracle cure. Here are three of the possible outcomes:

1.  Further independent studies by other researchers fail to replicate Dr. Zamboni's results. CCSVI is thrown on the trash heap of failed MS breakthroughs, which is becoming a very tall heap indeed.

For me, unfortunately, this is the least desirable but most likely scenario. I don't base this opinion on the facts of the case as much as I do on my experience as a long-suffering MS patient. Most great ideas simply do not pan out.

2. Some researchers are able to correlate some CCSVI cases with some MS cases. CCSVI continues to be studied, and a subset of the MS population benefits from new procedures developed to open up the stenosis (flow restrictions) in these veins.  More specifically, if only some MS patients benefit, it seems likely that it will be the more common relapsing remitting group, rather than the primary progressive group. This is a trend in MS treatment.

In my humble opinion, this is the second most likely outcome, and the second-most desirable one. Again, this is based on a gut feel from me, not a scientific argument for or against CCSVI.

3. Dr. Zamboni's findings are confirmed by independent researchers. CCSVI is identified as the primary cause of multiple sclerosis. The world of MS research and treatment is turned upside down. We stop concentrating on developing new and expensive drugs that only treat the symptoms or secondary causes of MS. Doctors develop safe and effective ways to repair CCSVI in patients. Eventually, when a young person who would otherwise have been diagnosed with MS speaks with his or her doctor, the doctor will say something like, “We found the cause of your problems. It is a condition called CCSVI. In the past it was referred to as multiple sclerosis. I scheduled a procedure for you next week. Since we found this early we should be able to easily repair it, and you should have no lasting effects. Have a nice day, and a nice life.”

Naturally, I consider this the most desirable and least likely outcome of the CCSVI saga. Wouldn’t that be a wonderful thing though?

Just to clarify, even if scenario 3 comes to be, people like me who have already suffered significant damage to our central nervous systems will not see much, if any, improvement in our current conditions. We would simply stop getting worse. I need to stop getting worse, like, yesterday. Getting better can wait.

So, given all this information, what actions am I taking personally? I may very well subject myself to an experimental repair of a theoretical condition well before others might find it prudent to do so, simply because I'm on the doorstep of becoming a complete invalid. My risk/reward appetite is skewed away from the conservative and toward the aggressive, and I believe that to be appropriate given my circumstances.  I'll try not to do something obviously stupid, but too much patience or indecision in this situation will yield a very predictable result.

Right now, as unlikely as I find CCSVI theory to be, it’s the best option I see out there, today.

Here are some more resources on CCSVI:

See my subsequent post  CCSVI- Is this the calm before the storm?

For a more detailed and very balanced discussion about CCSVI, see this overview by a fellow blogger:

A comprehensive website put together by an MS patient, tying to gather together many of the online resources dealing with CCSVI:

A link to a study being done at the Buffalo Neuroimaging Analysis Center, attempting to confirm the findings of Dr. Zamboni:

A link to the original publication of Dr. Zamboni’s findings:

A patient message board, called This Is MS, where the subject is discussed in great detail:

Dr. Zamboni will publish a second paper any day now. I’ll put that link here when it is available:  Here it is:

A Canadian Broadcasting Company piece on the University of Buffalo study (added 12/16/09)
Reblog this post [with Zemanta]

Thursday, November 26, 2009

My MS Story Chapter 19- Measuring the Immeasurable

Laboratory mouse
Image via Wikipedia
Because I participated in a clinical trial in 2005 - 2006, I have an appreciation for the life of a lab rat. OK, that’s a bit of an exaggeration. I took part in the trial of my own free will, and I got to go home almost every night. Never did I sleep on a bed of cedar shavings, nor did I drink from a bottle suspended on the side of my cage.

But, like a lab rat, I was given a substance that I officially did not know the composition of. I was poked and prodded and measured and tested and treated again and again for a period of two years. At times I felt as if I was in a maze, so the comparison has some merit.

Despite all the trips to Worcester and everything that I was asked to do, I never felt overwhelmed by it all. In fact, I was thrilled to be participating in this experiment. The buzz of activity associated with the trial made me feel that I was fighting back against MS. At least I was doing something. Furthermore, since I was pretty sure I was on the trial drug and not the placebo, I knew there was at least some possibility that I could be winning the battle with MS. The fact that I was contributing to scientific knowledge about MS was not lost on me either.

But how could we tell if the trial was working? In situations like this, it is the nature of engineers, scientists and doctors to try to quantify their observations. It's not enough to say that a patient has MS for example, or even to say that a patient has Primary Progressive MS. We need to measure the patients’ capabilities so that we can assign numerical values that describe just how bad their MS is. Throughout my life I've been as guilty of this need to quantify as anyone. I see the world so much more clearly when I can describe it with numbers.

In this clinical trial there were two primary, numerical measures of my disability. These two assessments were called the EDSS and MSFC tests.


Expanded Disability Status Scale

This is perhaps the most widely accepted MS disability metric. A completely healthy patient scores a zero. A patient who has difficulty walking more than 200 meters scores a 5.0. Someone confined to bed but still able to eat and communicate gets a 9.0. Death by MS scores you a 10.0. This is one of those rare situations where a perfect 10 is highly undesirable. When I started the trial my EDSS score was a 6.5. Today, my EDSS score is an 8.0.


Multiple Sclerosis Functional Composite

This is a three part assessment that measures walking ability, hand dexterity, and cognitive skills. The walking test was a simple 50 meter timed walk down the hallway. The hand dexterity test measured how long it took me to place 9 little round pegs into 9 holes (don’t worry, there were no square pegs, although on some level that would have been appropriate). The cognitive test was very interesting. Give it a try yourself. Here's how it worked.

A CD player read off random digits between 1 and 9, at a regular and relentless pace, pausing about 3 seconds between each number. My job was to add the previous two numbers in my head and verbally give the correct answer to Roberta, who was keeping track. For example, the red numbers below are the ones that the CD player read to me, and the black numbers are the answers that I gave. Remember, the red numbers were read off at a constant cadence, with a three second pause between each one. It was during this pause that I would do the quick addition in my head and give my answer.

6 (because 1 plus 5 is 6)
8 (because 5 plus 3 is 8)
12 (because 3 plus 9 is 12)
13 (because 9 plus 4 is 13)

And so on. This went on until 30 or 40 numbers had been read to me by the CD player. I scored very well on the test, but I hated it with a passion. It required a lot of concentration to avoid becoming confused. If I hesitated even a little the damn machine didn’t care and just kept shouting out numbers at me without mercy.

In addition to the EDSS and MSFC tests I was also given a bajillion of those general neurological examinations where you are asked to complete tasks like following the neurologists finger with your eyes, or using your index finger to alternately touch your nose and his hand as fast as you could, etc., etc. I had several of those wonderful MRIs. Before each one I would secretly pop a couple of Valium to counteract my claustrophobia. I was given one spinal tap during the trial. The three spinal taps that my local neurologist had given me over the years were relatively painless. This spinal tap doctor (not Peter) was a butcher. He kept poking and poking without hitting the spot he was looking for. Each poke sent an electrical shock up my spine. I shiver just thinking about it.

And then there was the blood testing- always the blood testing. I was tested every time I showed my face at the hospital. On those days when I had infusions, I was tested before and after the infusion. I was a virtual blood spigot.

My disease had progressed without interruption beginning when I first noticed my left foot slapping on the treadmill many years earlier. Then something most peculiar happened. After my first pair of Rituxan infusions the disease progression stopped- dead in its tracks.

For the next installment in this series, click here.
Enhanced by Zemanta

Monday, November 23, 2009

My MS Top 10 Lists

The Top 10 Reasons Why I Hate MS (at least my version of MS)

10. Accessibility problems in general, bathrooms in particular. 

9. MS costs too damn much money. Most years I spend enough out of pocket money on medical expenses to exceed the 7.5% of AGI required to claim medical expenses as a tax deduction, even after insurance payments are taken into account.

8. Because this is a progressive disease, sometimes I don’t know what it is I can’t do until all of a sudden I can’t do it anymore.  I spend a lot of times on the sidelines watching people take part in fun activities.

7.  I miss all the good things that come with working, including income; sense of accomplishment; sense of being engaged in worthy endeavors; spending time with customers, vendors, and coworkers who are some of the nicest people I know.

6. It’s hard to stay healthy and maintain good body weight when I’m so inactive.

5. I miss outdoor activities like snowmobiling, ATV riding, camping, and actually walking in the woods when I hunt (I still hunt from my wheelchair). No thanks, not interested in handicapped skiing.

4.  I am completely reliant on technology. If a disaster struck (nuclear war, asteroid smashes into the Earth, Yankees win another World Series) how would I survive?

3. I hesitate to talk about things in the distant future, because the future is so fuzzy for me.  When others talk about their long term hopes and dreams, I don’t participate in the discussion.

2. So many people- my wife, my kids, many others- need to go out of their way to help me. I know they don’t mind, but I’m bothered that I must ask them to.

And the number 1 reason I hate my brand of MS is…

1.  No known cause, no disease modifying treatment, no cure.

The Top 10 Silver Linings of Having MS

Let me be perfectly clear about this- MS sucks! But my life has changed so much due to MS, and some of that change has been for the better.  It's been a one step forward, ten steps back process.  Here are some of the steps forward:

10. I have time to keep up this blog.

9.  I’ve met so many wonderful people I would have never otherwise met: people with MS, medical professionals, people who just care.

8.  Lifetime, complementary hunting license and state-wide doe permit.

7.  I can now justify the “3 movies at a time” option at Netflix.

6.  Wheelchair accessible tickets for Red Sox, Patriots, and Celtics are so much easier to get than normal tickets.
Fenway 03
5.  I physically cannot clean a bathroom, rake leaves, or vacuum the house- three things I hated to do anyway.  Please, do not forward amazing new discoveries that will allow me to do any of these things again.

4.  I’ve become a better person in several ways. I’ve had to adopt Zen perspectives like “living for the moment” and “mindfulness” that I should have adopted anyway, but probably wouldn’t have if not for MS. I keep things in perspective better now. I don’t sweat the small stuff as much.

3.  I get preferential treatment wherever there are long lines: amusement parks, museums, boarding airplanes, etc.

2.  I’m out of the corporate rat race.  I run a lot of “if I had it to do over again” career scenarios in my head.  If I had a do-over, I doubt I would choose the corporate life again.  I missed out on my calling, whatever that was.

And the number 1 silver lining of having MS is…

1.  Handicapped parking.  Enough said?

106/365 uno, dos, tres, quattro, count 'em cin...

For those of you with MS, what are your top reasons to hate MS, and what are your silver linings? 
Reblog this post [with Zemanta]

Thursday, November 19, 2009

My MS Story Chapter 18- Mobility aids, who needs 'em?

A day when you first incorporate a new mobility aid is a milestone day indeed, but not in the way you might think.

Sure, as my disease has progressed and my abilities have diminished, I’ve employed assistive devices that are more and more, well, assistive. So looking at the big picture, it would seem reasonable to say that the use of increasingly elaborate mobility aids correlates with increased disability, and that’s not a good thing, so mobility aids are a bad thing.
But this would be a mistake.  Although mobility aids are markers of disease progression, they are not causes. In fact, they are allies in the war I’m fighting. In every case, when I’ve first adopted a new mobility aid, I’ve thought something along the lines of, “This is really cool. I’ve needed help for so long. Why didn’t I get a (cane/crutch/scooter/wheelchair/sexy nurse) sooner?” These have all been happy days, like Christmas, or at least like Root Canal Appreciation Day.

The sad days have been those days when I realize that I can no longer do something that I’ve always done in the past, but that sadness has never been the fault of a mobility aid.

So rather than use a phrase like “Mitch is confined to a wheelchair,” it would be appropriate to say “Mitch is confined by MS,” or even “Mitch is liberated by his wheelchair.”

If you read my post on Judy the Physical Therapist, you may recall that when I visited her for the first time I was using a wooden cane to help with walking. One of the first things Judy did, in an act that I characterize as picking the low hanging fruit, was to grab a pair of demonstration forearm crutches, adjust them for my height, and let me try them out. Wow! What a difference.

These crutches were an improvement over the cane in two ways. Look again at the photo of my wooden cane, above. Notice that the connection to my arm exists only at my hand. This is not a very rigorous connection. It’s the weak point of the whole arrangement, kind of like that little piece attached to each leg on the underside of a folding table. If the piece is locked in position, then all is well. If you break that link though, the table leg folds, whether you want it to or not.

Now look at the photo below of the forearm crutches. They link up with my arm in two locations. My hand connects in a similar manner as with the wooden cane, but there's a second connection point further up on the forearm. So using even one forearm crutch is already much more stable than using a cane. The crutch feels like a natural extension of my arm.

The other improvement with the forearm crutches is obvious- there are two of them. Your body makes contact with the earth in not two places, not in three places, but in four places. Think about the stability of a bicycle, versus a tricycle, versus a car.

Another nice feature of the forearm crutches is that you can let go with your hands and the crutch doesn't fall to the ground, as depicted below. This frees up your hands for whatever activity you need them to do.

Quick aside:  How is a fulltime wheelchair user able to stand for these photos?  Well, because of the spasticity in my legs I am able to stand for a few seconds as long as I can hold on to something for stability.  I can’t move my legs (take a step) anymore, even with both crutches.  Spasticity is not all bad (just half bad). 

The same day that Judy introduced me to forearm crutches I went to a medical supply store and purchased a pair. Initially I would often use only a single crutch, to leave my other arm completely free, and, well, frankly to appear less disabled. A person using a single cane or crutch has some difficulty. A person using a pair of forearm crutches is a cripple, or so I thought. Over time though, I naturally gravitated toward the added stability that came with using two crutches instead of one. This migration was due both to overcoming my feelings of conspicuousness and to simply needing more support as my condition worsened.

After just a couple of weeks with the forearm crutches I realized that although they gave me a lot of added stability, they did not address the issue of fatigue. I still could not walk very far without my legs becoming too weak to continue. Luckily, I knew just the device I needed for those longer walks. I had rented one a year earlier when I toured Washington DC. It was time for an electric scooter.

I did my due diligence (as those of you who know me personally can imagine) and found the ideal electric scooter. Insurance paid for most of it. I also bought a portable ramp so that I could get the scooter in and out of my minivan. We removed the minivan’s middle seat for this purpose.

I also purchased an attachment for the back of the scooter so that I could carry my forearm crutches with me. I would use the scooter to get from point A to point B if these two points were sufficiently far apart, and then use my crutches at the destination. For the longest time though, I did not use the scooter in my house or at my place of work. I’ll write about those transitions in a later post.

If a cane implies some difficulty, and crutches shout out “cripple,” then what does a scooter say? How about old, miserable, frail, overweight, mentally challenged? These are not nice terms, I know, but actual connotations nonetheless. That’s why I always made an effort when driving my scooter to engage people that I encountered, to show them that I was none of these things. Well, I was a bit overweight.

For the next three years I was a crutches and scooter kind of guy. In May of 2005 I was using my crutches 95% of the time and my scooter 5% of the time. By July of 2008, just before I got my iBOT wheelchair, those percentages were reversed.

Thursday, November 12, 2009

My MS Story Chapter 17- There Will be Blood

Roulette Wheel 08
Image by marc e marc via Flickr
I was entrusting my healthcare to complete strangers, and these strangers didn’t even know what substance they were pumping into my veins. Maybe it was a powerful immunosuppressant, or maybe it was sugar water.

I’ve always been a bit of a risk taker. You probably know several people who’ve had laser eye surgery. Maybe you’ve even had Lasik yourself. Back in 1993, before laser eye surgery was available, I allowed an ophthalmologist to reshape my corneas by hand using a procedure called radial keratotomy. (Dr. Werner, wherever you are, I hope you eventually had your medical license reinstated. You got a bum rap.) As you can see, accepting risk in return for potentially significant rewards was not exactly out of character for me. By the way, I’m now on year 16 of not wearing glasses or contacts. I hated glasses and contacts. I hate MS even more.

Roberta, Kathy and Peter, employees of UMass Memorial Hospital, would become very important people in my life. Over the coming years I would see more of them than I would of anyone other than my wife and kids or coworkers, and certainly more often than I would see my local medical team.

Kathy, the trial coordinator and a nurse, was my primary point of contact and eventually my good friend. Within five minutes of meeting her, she was poking around my arms and hands looking for a vein from which to extract a blood sample. Because the trial protocol required so much patient health data, Kathy became bloodthirsty. I wonder just how many vials she filled over the next couple of years- too many. This blood collection adventure didn’t go smoothly at first.

Kathy was not an experienced phlebotomist. She understood the basics of taking blood samples and was technically qualified. Clearly, however, this was not her area of expertise. To complicate matters, I don’t give blood easily. I've managed to frustrate even the most veteran phlebotomists over the years. My veins are just not visible. If you determine where there might be one, by feel, the vein is likely to roll out of the way when you poke it with a needle. After a couple of months, however, we identified a magic spot in my right arm where Kathy could almost always strike red gold on her first try.

Roberta was also a nurse. She administered two tests called the MSFC and the EDSS (more on them in later posts). These were the primary tests used to evaluate the condition of the trial participants by measuring feats of strength, dexterity, vision, and cognitive ability. Roberta was a lovely lady- pleasant, engaging, and always professional.

Peter was the medical director of the MS clinic. He was both an MD and a PhD, as this was a teaching hospital. Peter was absolutely brilliant. He was a renowned leader in the field of MS treatment, but remained down-to-earth and unassuming despite his lofty credentials. He even asked that everyone refer to him by his first name.  I wonder sometimes what sort of doctor decides to specialize in MS. Why not choose a less depressing field where you occasionally cure patients, like maybe oncology?

On June 2, 2005, on my fourth visit to Worcester, I received my first infusion. In my previous post, My MS Story #16, I described my serious reservations about sticking with this trial for 2 1/2 years if I suspected that I was on the placebo instead of the trial drug. Before my first infusion I had studied the side effect profile for Rituxan, which was well documented. If I was on the trial drug, all was well. If I was on the placebo, all bets were off.

During the first infusion my blood pressure slowly dropped and my body temperature steadily increased. These were both classic Rituxan side effects. In fact, as I later learned, if my temperature had risen any a higher the nurse would have suspended the infusion. On the drive home I spoke with Kim about whether or not this was conclusive evidence that I had just received an infusion of Rituxan. I wondered, “They wouldn't give me a placebo that would raise my body temperature, just to throw me off track, would they?”

Later, before we had arrived home, I developed a significant headache. I didn't remember reading about headaches as a side effect. When we got home I pulled up the information I had on Rituxan. How had I missed it? One of the primary side effects of the initial infusion of Rituxan is a headache. I was inching ever closer to concluding that I was on Rituxan. There was just one more piece to the puzzle.

With Rituxan treatment, any reactions you experience during the first infusion are typically not present at the second. Two weeks later, on June 16, 2005, I had my second infusion. Sure enough, I had zero side effects. I was convinced. Hooray! I was getting the real thing. I had some hope of stabilizing this damn disease.

Stabilization was the ultimate goal of this treatment. Suppressing the B cells in my immune system, which is what Rituxan was designed to do, might slow down or even stop the progression of my disease. There was no reason to believe that any of the damage already done could be reversed by Rituxan. With a progressive disease like MS, the primary goal is to halt the damage- to stop the bleeding. If you can do this, you can buy time while you wait for some medical advancement that will repair myelin and re-grow axons.

That's all I was doing by participating in this trial. I was just trying to stop the bleeding.

For the next installment in this series, click here.
Enhanced by Zemanta

Thursday, November 5, 2009

My MS Story Chapter 16- The Clinical Trial Begins

(Photo credit: jeff_golden)
In early 2005 I was accepted into the Rituxan clinical trial, or so I was told. I kept waiting for word on when I should show up in Worcester for my first appointment, but the months kept going by. The start of the trial was perpetually imminent.

Finally, in May of 2005 I got the call instructing me to report to the UMass Memorial Hospital in Worcester, Massachusetts for my first appointment. I was excited about the trial, but not in the way that some people get excited about prospects like this. Let me explain. Oftentimes, when people who are in dire straits see a rare opportunity, they invest emotionally in a positive outcome. They seize hope and hold on tightly.

“I know this will work.”

“Fate has brought me here. Everything happens for a reason.”

“This is the answer to my prayers.”

I'm not finding fault with people who operate in this manner. It's just not me. I had a modest level of optimism because the pharmaceutical company was investing a lot of money in this trial. Some project manager or product manager or vice president had stuck his neck out to advocate for this very expensive experiment. The fact that a board of directors was allowing the expenditure of precious corporate assets made me feel that this trial had a better than average chance of success.

I was enthusiastic and cautiously optimistic, but I knew that no trial in the history of clinical trials had ever produced a treatment for PPMS.

The protocol for this trial was double-blind, placebo-controlled. The placebo-controlled part, at least in this case, meant that two thirds of the participants would receive Rituxan and one third would receive a placebo. The double-blind part meant that both the patient and the treating physician (and his/her staff) were blind to whether the patient was receiving Rituxan or a placebo. Only a few nameless, faceless (at least to me) data analysts would know who was who.

Each trial participant was making a 2½ year commitment that we would not undergo any other MS treatments and that we would show up in Worcester between one and four times a month for treatments and examinations. For me, it was a two hour drive to the trial hospital, each way. This was a huge commitment.

It bothered me that I might forego all other treatment options, as unpromising as they might have been, while receiving nothing but a placebo for 2½ years. This was a frightening prospect, especially since I had a progressive disease. Left untreated, I could only guess what my condition would be 2½ years down the road. Those of us who participate in clinical trials are often heralded for our unselfishness. We risk our health for the cause of science, but let's examine that concept a little more closely.

If I knew that a certain placebo-controlled clinical trial would produce results beneficial to mankind, then that would be one deeply personal decision for me to make. However, in the clinical trial world it is very unlikely that patients’ sacrifices will contribute to significant medical progress. Most clinical trials fail, especially clinical trials for PPMS. Scientists are quick to point out that even failed trials yield important scientific and medical information. Okay, I'll concede that point, sort of.

My health and well-being may be worth sacrificing for significant medical progress. However, there is no way that my health is worth sacrificing for tidbits of scientific information that may or may not ever make a difference to anyone. Furthermore, my health is clearly not worth sacrificing simply for the financial gains of a pharmaceutical company.

But evaluating all of this from the front end of a trial is daunting. You don’t know anything. You don’t know if this trial could be THE trial. You can’t possibly know if you’re making a huge mistake. You just can’t anticipate what your world will look like 2½ years down the road, with or without the trial.

There was one fact that made my decision to go forward easier, though. I simply had no better option.

So I came up with a plan. I decided to break the rules and make every reasonable effort to ascertain whether I was on the placebo or the trial drug. If I determined that I was actually getting Rituxan, I would stick with the trial until the end. If I determined that I was on the placebo, that would be another story. I would secretly reserve the right to withdraw from the trial if I felt that I was missing out on some other opportunity to fight the disease.  This might mean that I would be a quitter, something Mom and Dad and the President and Jesus told me I shouldn’t be. Nevertheless, this was the only plan I could live with.

So how in the world could I outsmart these brilliant doctors and figure out if I was on the trial drug or a placebo? I couldn't figure it out with certainty, but I had some ideas.

Because Rituxan was already being used for cancer patients there was a lot of documentation about its side effects. I learned that when somebody gets their first infusion of Rituxan their blood pressure typically drops and their core body temperature typically rises. Sometimes they have a more severe respiratory reaction that forces the infusion to be temporarily stopped. On subsequent infusions there are usually no side effects at all. So my plan was to see if I had the side effects on infusion one, but not on infusion two, which would come only two weeks later.

As a friend of mine said to me, “You need to be in this trial because it might make Mitch better, not because it might further scientific knowledge. If you happen to contribute to a medical science in the process, then that’s just a bonus.”

Selfish? Perhaps. Do I regret taking this position? Not one bit.

In fact I did withdraw from the trial before its completion- not because I thought I was on the placebo, but for a completely different reason.

For the next installment in this series, click here.
Enhanced by Zemanta

Sunday, November 1, 2009

My MS Story Chapter 15 – Judy the Physical Therapist

In February of 2005 I developed a mysterious pain in my right shoulder, and I just couldn’t shake it. My doctor recommended that I see a physical therapist. Her people made an appointment for me with Judy. By a cosmic stroke of luck, Judy was also the rehab clinic’s MS specialist.

I told Judy about my sore shoulder, but frankly she could not have been less interested, and rightfully so. Here was a real, live MS patient in front of her- a patient at that critical juncture where walking was beginning to fail. Furthermore, I had never received the services of a physical therapist since my diagnosis. That meant that I was a physical therapy MS virgin, gift wrapped and left on her front doorstep. Judy tactfully explained to me that I had much bigger issues than a sore shoulder, and she was right. The shoulder pain soon cleared up on its own, and, well, I still have MS.

At one appointment Judy asked me if I had driven myself to the clinic. I sensed where she was going with this seemingly innocuous question. I was taken aback, maybe even a little insulted. I replied that I was fully independent, and of course I had driven myself to the appointment; thank you for asking. She pleasantly but firmly indicated that she was surprised, given how weak my legs were (speaking pleasantly but firmly is a required skill for a physical therapist).

After that session I began to pay closer attention to my driving. Holy crap! I was taking some serious shortcuts. Leisurely drives along the interstate were not the issue. The issue was with city driving, where I frequently had to move my right foot from gas to brake and back again. I was actually compensating by using my right hand to grab my pant leg just above the knee and assist my right leg in these brake-to-gas-to-brake transitions. I hadn't even realized I was doing it. Judy was right again.

As luck would have it, there are ways to drive a car without using your legs. The first step was to get hand control driving lessons, which Judy set up for me. It was a bit odd at first, but I got used to it. I simply needed to practice enough so that the connections in my brain that had previously traveled to my right leg for driving were rerouted to my left hand. After a couple of weeks it became automatic. The next step was to find a company who would install the hand controls into my two vehicles for me. I did find one, at $1,400 per vehicle, and no insurance help.

One day I received a letter from the State of Maine, indicating that I needed to take a driver's exam with my new hand controls in order to continue driving. Judy had forewarned me that an exam would be required, but I hadn’t really thought it all the way through. I was expecting to have it both ways. I was expecting to drive with my feet when they felt strong enough, and with my hands when they seemed like the best option (hand controls are set up so this is possible when others drive my car). Whose business was it anyway how I chose to drive?

It turns out that it was the State’s business. Once I started the process of acquiring hand controls there was no turning back. As far as the State was concerned I had to get my new license for hand controls and surrender my old license. These people were treating me like I was disabled or something. Come on.

I showed up at the Department of Motor Vehicles at the appointed time. I then sat down among the 16-year-olds and their parents to wait for my name to be called by an examiner. My parents did not accompany me.

Fortunately, this examiner was unlike the gentleman who failed me on my first try as a 15 year old. He seemed human, and quickly put me at ease. He was the special medical examiner. If you had suffered a stroke or had a limb amputated then you needed to demonstrate to this guy that you could still function adequately behind the wheel, in order to get your license back. Or, if you have a progressive disease and needed certain driving adaptations, like I did, then you had to pass muster with this guy.

The examiner shared a story with me as I drove around the streets of Portland, more deliberately than I had ever driven these streets before, or since. A few weeks earlier a person who had lost his license due to mental illness was taking the driver’s exam in order to get his license reinstated. The examiner asked the driver to parallel park. As everyone knows, this is easily the most stressful part of the driver’s exam. The driver struggled with the task and began arguing with himself in two different voices, as if the examiner was not even present.

“You idiot! Can’t you even park a car correctly?”

“Shut up. Leave me alone. You’re not helping things.”

“You big dummy. You are going to fail this test, aren’t you?”

“Shut up!”

And so on…

The mean spirited personality was right. The examiner was compelled to fail this driver. Breaking that news to somebody who had already been through hell and back (or not quite all the way back) was not fun. I guess, in the grand scheme of things, MS was not the worst driving handicap that I could have.

I passed my driving exam without any difficulty. For a while afterward I would still use my right foot to temporarily operate the brake or the gas pedal, usually if I had something else to do with one of my hands. But now I can’t remember the last time I touched a brake or gas pedal with my feet. In fact, since I was issued my special driver’s license I have not operated a vehicle unless it was equipped with hand controls (I learned that you can rent cars this way).

My advice to anyone who is indecisive about adaptive driving controls- don't be.  They will only make your driving easier and safer, and they don't take long to get used to.

Thanks, Judy, for helping me out so much back in 2005. You are the best. It’s probably time for me to come see you again. I’ve got a whole new set of issues for you to look at- you lucky girl, you.

Below is a quick hand controls tutorial.  Pictures were taken in my wheelchair accessible minivan. 


A: Primary control lever
    I push this lever forward for brake and down for gas

B: Right hand turning signal controller
    I need to be able to operate the blinkers with either hand, whichever is least busy at the time

C: Spinner knob
    Also referred to as the suicide ball. If you get in an accident you don’t want this to impale you. Allows me to easily operate steering wheel with one hand.

D: Horn

E: High/low beam switch

(click on photos to enlarge)

View from driver’s side door

Driver’s view

View showing the connections at the pedals.  Note that the connections do not interfere with normal operation of the brake and gas pedals.