Saturday, March 27, 2010

CCSVI- Diagnosis and Treatment Log Entry #7

In Log Entry #6 I wrote about what the experience was like for me during the actual CCSVI procedure. Here, in Log Entry #7, I’ll get into the details about the abnormalities that were found, and the actions taken to correct them. To catch up on my complete CCSVI Diagnosis and Treatment log, click here (and then scroll down). 

What an amazing experience it was.

Right Internal Jugular

An angiogram, which is an X-ray test using a special dye and camera to take pictures of the blood flow in the vein, was performed in the right internal jugular vein. This revealed a short segment stenosis adjacent to the confluence of the brachiocephalic vein. The diameter reduction associated with this stenosis was approximately 60%. The more important number, relative to flow restriction, is the cross sectional area reduction which in this case was approximately 85%.

Multiple collateral veins were noted at this location. Collateral veins indicate attempts by the body to establish bypass flow around an obstruction. Dr. Sclafani inserted the intravascular ultrasound device (IVUS) and confirmed the stenosis. A balloon was inserted, and the vein was dilated multiple times. Another angiogram was performed after dilation which indicated improved flow, diminished flow through collaterals, and no stenosis. Note that the nominal diameter of this blood vessel was 12 mm. Dr. Sclafani prefers to slightly over-dilate the vessel in these instances, and so a 14mm x 4 cm balloon was used.  Click on any image to enlarge it. 

RIJV angiogram 01 RIJV partial inflate 01 RIJV full inflate 01

From left to right, the first image shows the stenosis during angiogram. The second image shows the balloon partially inflated. Note evidence of the stenosis resisting dilation. The third image shows the vein fully dilated.

Left Internal Jugular

An angiogram was performed in the left internal jugular vein. This revealed a stenosis at the confluence with the subclavian vein. The degree of narrowing was similar to that in the right internal jugular vein, approximately 60% diameter reduction and 85% cross sectional area reduction. Collateral veins were noted at this location. The IVUS probe was inserted and confirmed stenosis. A 14 mm x 4 cm balloon was inserted, and the vein was dilated multiple times. Another angiogram was performed after dilation which indicated improved flow, diminished flow through collaterals, and no stenosis.

LIJV stenosis 01

The above image shows the stenosis during angiogram.

LIJV partial inflate 01 LIJV full inflate 01

The above images show the balloon during inflation.  Note evidence of the stenosis resisting dilation.

LIJV after 01

Above, angiogram after dilation, showing improved flow through the vein.

Azygos Vein

An angiogram was performed and indicated an abrupt lack of filling approximately 4 cm from the junction between the azygos and the superior vena cava. Dr. Sclafani inserted the IVUS device, which revealed a valve that was failing to completely open. This area was dilated with a 10 mm x 2 cm balloon. Note that the nominal vessel diameter at this location was approximately 8 mm. Another angiogram was performed, and improved flow was noted.

Above is an image of a shorter balloon being used to dilate the azygos at a relatively sharp turn in the vein.

Vertebral Veins

An angiogram was performed on the right vertebral vein. Stenosis was noted, but not treated. This is a smaller vein, and Dr. Sclafani was not comfortable performing angioplasty on it.

An angiogram was performed on the left vertebral vein, indicating that the vein branched into two smaller veins, which is abnormal. No treatment was attempted.

IVUS Images

Dr. Sclafani is innovating the use of IVUS technology in CCSVI diagnosis. I’ll have to take Dr. Sclafani’s word regarding what these images show. Maybe they are like the 3-D pictures that were so popular in the 1990’s. You remember- stare at them long enough and you see dolphins jumping over rainbows (or am I thinking about something else altogether). Anyway, here are some example images.

IVUS rest LIJV IVUS inspiration LIJV

Above, the image to the left shows narrowing of the left internal jugular vein. The image to the right shows the same vein distended during inspiration (breathing in). Wait! I think I see it now. Do you?

IVUS bad valve 1 IVUS bad valve 2

The images above show an incompletely opening valve.  I kinda see it.

Significance of findings and treatment

Most of the public discourse regarding CCSVI has been regarding the internal jugular veins and the azygos vein, so I will address these first.  All three veins showed some type of stenosis, which is a significant finding. The fact that all three stenoses were repaired after angioplasty is potentially significant for my disease progression. 

On the other side of the equation, it is unknown whether the repair of these stenoses will be permanent. Furthermore, since most of my lesion load is in the cervical spine, it is unclear how much benefit I will see from even permanent treatment of stenoses in the internal jugular veins.

The findings of stenosis in the vertebral veins may be significant, given the location of my primary lesion load. In my situation, the vertebral veins may be a more important factor than they are in patients with a lesion load primarily in the brain. This remains to be seen.

Below is an MRI image of my cervical spine. This is the problem we are trying to solve (or at least halt the further progression of).  Arrows indicate MS lesions.

The Bottom Line

I had abnormalities in five out of five veins examined- all are blood vessels that drain my central nervous system. Therefore, it can be said that I had significant CCSVI. The three larger veins were all treated with angioplasty. The two smaller vertebral veins were not treated. One day I hope that we can attempt to treat at least one of these vertebral veins.

Only time will tell if Dr. Sclafani’s efforts were enough to slow or even stop the progression of my MS. I can only hope.

Friday, March 26, 2010

Some Links I’ve Come Across Lately

I’m still working on finalizing a post with more details of my CCSVI procedure on March 17, but it’s not ready yet.  I’m fully recovered from the procedure (but not from MS).

In the meantime, I want to share two links with you.  At long last, the U.S. media has taken notice of CCSVI.  On Monday, March 22, the Associated Press issued this report, and on Thursday, March 25, the Wall Street Journal ran this piece.

I rate both articles with a solid C. The reporters got some things right, some things wrong, and omitted some important facts.  But this is a start.  I expect much more detailed media coverage in the coming years.  Some of it will be well done, and some of it will be crap.

I also want to share this gut wrenching video with you.  You cannot help but be impressed by Carolyn’s strength and courage.  She calls for a cure, not so much for herself, but for those who follow her.   

Friday, March 19, 2010

CCSVI- Diagnosis and Treatment Log Entry #6

“Life is either a daring adventure or nothing.”  Helen Keller

IMG_1356I can’t recall the precise moment when I decided that CCSVI was a legitimate theory about the root cause of MS. Probably it was in October of 2009. I was influenced, like so many of us are, by my friend the Wheelchair Kamikaze. If he thinks something is legitimate, it usually is. CCSVI really became clear to me when I sat down and spent about 6 hours reading through the TIMS message board. From that point forward, all other theories about treating MS became just so much background noise. Sorry, Big Pharma.

I will relate the rest of my CCSVI diagnosis and treatment story in two parts. This post will address what the experience was like from a patient’s perspective- mine. The second post will go into more detail about what was found in my veins, and exactly how it was treated by Dr. Sclafani, at King’s County Hospital Center in Brooklyn, NY.  Before I publish that second post, I’ll need to run it by Dr. Sclafani for accuracy (see the photo of the good doctor and me at top, with a photo of one of my veins on the monitor).

Although I approached this CCSVI adventure with a mixture of optimism and realism, I didn’t feel any apprehension. After I made the decision to follow this road, I never looked back. I was not confident in the result, but I was convinced that I had no better option.

I’ll pick up the story on Wednesday, St. Patrick’s Day, 2010 (see previous posts for an accounting of the days leading up to my procedure day). Kim and I arrived at the hospital around 11:30, because our new friend, Barbara, was being treated by Dr. Sclafani first. Holly, Dr. Sclafani’s capable assistant escorted us to the surgical intake area, and handed us off to that team. I filled out some paperwork, and we waited and waited. Finally, the surgical nurse came out and led me into the prep area.   

IMG_1348 Kim helped me change from my street clothes into some surgical gowns that, well, were only marginally better than being naked. But you soon lose any semblance of modesty while undergoing this procedure, given that the doctors are operating from an access point near your groin.

The nurse started an IV in my arm. She was successful on the second try, which is par for the course for me. The nurses and Kim together transferred me from my wheelchair to a stretcher. Kim was allowed to stay by my side until it was time to move me into the operating room, which happened about 30 minutes after Barbara’s procedure was done.

Once I was in the operating room the nurses and technicians hooked me up to various monitors, and began to prep the area where the catheter would be inserted. When Dr. Sclafani arrived he stopped the show for a minute to conduct some legal, and frankly polite, formalities. He introduced his team and asked me to introduce myself. He asked me why I was there, and what procedure I was expecting to receive. This is a required step in New York to prevent medical errors, like doing brain surgery on a patient with tennis elbow, for example.

After I was given the local anesthesia at the injection point, there was no more pain involved with this procedure. There were, however, some very odd sensations when the catheter was moved around my venous system, when dye was released into my veins, and when balloons were inflated. It was all good though. That was where I wanted to be, and those were the experiences I wanted to have.

Dr. Sclafani first examined my right internal jugular vein. I could actually hear the whoosh sound of the dye as it was released into my vein. By watching the behavior of the dye on a monitor, and by using a tiny ultrasound device from inside the vein, he found stenosis in the right jugular, and ballooned it. He also found very similar stenosis in the left jugular, and ballooned that. Nice symmetry, huh? He identified a problem with a valve in my azygos vein, and ballooned it. He also found issues in both of my vertebral veins but was not able to correct those.

I didn't always feel the catheter moving around in my chest and neck, but once in a while I could sense its location.  But again, these sensations were subtle, and not at all frightening.  I could sometimes feel when the balloon was being expanded, and other times I could not.  When I felt it, it was not a sharp sensation, but rather like a momentary feeling of gas (the burping kind of gas).

Once the procedure was complete, the catheter was removed. A nurse applied significant pressure to the injection site for 20 minutes, and then covered it with a garden variety band-aid. I was then transferred from the operating table to a stretcher, and wheeled off to another room, where I had to lie still for an hour to let the injection site completely heal.

I love my wife dearly, and she was a rock for me the entire week. She really took care of me. I’m blessed to have her. But, when she walked into the recovery room with a sandwich in her hand, I may have shown the sandwich a little more love and appreciation than I did my wife. After all, I’d been fasting for quite a few hours. Sorry honey.

Although we had discussed the possibility of my spending the night in the hospital, I think that Dr. Sclafani is finding this to be generally unnecessary. So we drove back to the hotel, and I enjoyed a comfortable night’s sleep. At about 11:00 on Thursday Kim and I met with Dr. Sclafani to go over the procedure and the images in detail. We were home in Maine by 10:00 Thursday night. What an experience!

IMG_1352 - CopyDr. Sclafani’s assistant, Holly, is an amazing woman (picture on right). She is now managing the entire CCSVI patient workload, while still doing her "day job" for Dr. Sclafani.  I’ve received emails and calls from her at some pretty odd hours of the day, which speaks to her dedication to her patients. She knows she is doing important work, and thrives on it.

Each time I met with Dr. Sclafani this week, I became more impressed with him. He cares deeply about his patients, and cares relatively little about what others think of his foray into experimental MS treatment (and I mean this in a good way). The word “maverick” comes to mind. Yet, he is anything but reckless. He’s just the sort of doctor that the CCSVI movement needs.

As soon as I can I will post more details about what was found, and how it was treated.

How am I doing, you ask? I’m doing just fine, thank you. Ask me again in six months or a year, and I may be able to tell you if this procedure had any positive effect on my disease progression.  Wouldn’t that be something?

Wednesday, March 17, 2010

CCSVI- Diagnosis and Treatment Log Entry #5

Just a short note to let everyone know that today's procedure went well. Dr. Sclafani successfully used angioplasty on both of my jugular veins and my azygos vein. I have a meeting with him tomorrow where I'll get more details on just how severe the stenosis was.

I'm in my hotel room now, and expect to be sleeping in my own bed tomorrow night.

No miracle changes on the operating table. It may take me many months to assess the impact.

No matter the final results, it was a most interesting experience.

I will blog in more detail later.

CCSVI- Diagnosis and Treatment Log Entry #4

I have a couple of hours to kill before I leave for the hospital this morning for my CCSVI venogram and possible angioplasty, so I thought I’d blog for a few minutes.

I was critical of MRV’s and ultrasounds in my post last night. Let me qualify that a little bit. For someone in my situation, who will be getting the gold standard for CCSVI diagnostic tests later today (venogram), the noninvasive tests I underwent yesterday are relatively unimportant to me.

But we do need to come up with a set of noninvasive tests that are accurate and repeatable, for a couple of reasons. First, administering a venogram to every MS patient in the world would be a tough sell, today anyway. It is an expensive test, and it is somewhat invasive. So we need a screening tool, but it can't be a screening tool that has high false negatives or high false positives. At this point in the early “life” of CCSVI, it takes someone with the experience level of Dr. Zamboni’s team in order to accomplish this. It takes practice. It takes repetitions. Some organizations around the globe are starting to gain this valuable experience, but so many other organizations are just getting started.

Second, we need a noninvasive test in order to examine those patients who have already undergone a CCSVI procedure. Those people will want to have their CCSVI repair evaluated periodically in order to determine if the veins that were opened have closed (re-stenosed). It’s not practical to have those patients submit to an invasive test every six months or year.

So, although I consider the ultrasound and MRV to be imperfect tools at this time, I am not advocating that we discard them. I am advocating that we perfect their use in CCSVI diagnosis.

Tuesday, March 16, 2010

CCSVI- Diagnosis and Treatment Log Entry #3

The most exciting phrase to hear in science, the one that heralds new discoveries, is not 'Eureka!' (I found it!) but 'That's funny ...'
  - Isaac Asimov

If yesterday showed King’s County Hospital Center at its worst- slow service, confusion, piles and piles of sometimes redundant paperwork- then today revealed the hospital at its best. In one day I had an Ultrasound, MRV, neurological exam, and consultation with Dr. Sclafani (photo below). Everything went off like clockwork.


This is such a learning experience for me, and for all of us. I learned something today which I began to suspect a week or so ago. Noninvasive procedures such as ultrasound and MRV have minimal value, especially when they are being conducted by people without a huge amount of experience in diagnosing CCSVI this way (which is almost everyone), and especially when you plan to undergo a venogram the following day anyway. My ultrasound today probably showed no CCSVI issues, or maybe it did. Who knows? Who cares? Today’s MRV of my jugular veins may have indicated some CCSVI, or maybe it didn’t. Who knows? Who cares? The azygos vein was not scanned at all today, and according to Dr. Zamboni this is the vein most often associated with stenosis in primary progressive MS.

Use of these noninvasive tests are a bit like trying to map the surface of the moon by viewing it through a telescope. The venogram is more like mapping the moon by walking on the surface- with a surveyor’s transit in your hand. Tomorrow, Dr. Sclafani will be walking on the moon for me.

Barbara, who is the other person being treated this week, is first up tomorrow morning. I’ve grown to know Barbara quite well this week. She’s an incredible woman who deserves some sort of relief from MS as much as anyone does. I’ll be rooting for her.

When Barbara is done, it will be my turn. I won’t be able to report out to relatives and close friends until late afternoon or early evening. I may or may not be able to blog about my experience tomorrow night.

Am I nervous? A little. I’m not anxious about the procedure itself. I’m worried that I could be the first MS patient of Dr. Sclafani’s who does not have CCSVI. Lying on that table tomorrow, wide awake, with a catheter wandering around in my venous system, I’ll be thrilled if I hear Dr. Sclafani utter something along the lines of “that’s funny…”

CCSVI- Diagnosis and Treatment Log Entry #2

Today was a day of hurry up and wait.  Nothing accomplished other than paperwork, etc.  Tomorrow should be busy with MRV, Ultrasound, and consults.  It’s late, and today was uneventful, so this post will be short.

Why is it late, you ask?  Well, Kim and I went to dinner in Manhattan with a group that included some MS friends of mine.


Left to right:  Michelle (bestadmom), Marc (Wheelchair Kamikaze), Barbara (Montana), Mitch (Enjoying the Ride)

Oh, and I now have clearance to share Dr. X’s name.  He is the same physician who has already treated Michelle and Marc- Dr. Salvatore Sclafani of the Kings Country Hospital Center in Brooklyn, NY.

I hope to leave a much more detailed post tomorrow, because I’ll be less tired, and, frankly, I should have more to write about.

Sunday, March 14, 2010

CCSVI- Diagnosis and Treatment Log Entry #1

English: There's a light at the end of the tun...
(Photo credit: Wikipedia)
As I indicated in my previous post, this is my CCSVI week- diagnosis and hopefully treatment. I plan to update this blog frequently with details of my adventure. This post is installment #1.

My lovely wife and I made the trek from Maine to our hotel room- a 5 hour drive without traffic, bathroom breaks, wrong turns, etc. So, it was about 7 hours total. I have this hotel room reserved for 8 nights, but I’ll be looking for another room tomorrow. I’ve learned over time that the term “wheelchair accessible” is a very subjective one indeed. I’ve traveled a lot in my wheelchair, and this is the smallest “wheelchair accessible” room I’ve ever seen. I can’t even turn my chair around in it. I have to drive in, and back out. I won’t trouble you with a description of how complicated it is for me to use the bathroom.

But we’ll survive one night anyway. The internet access is good, and free, and the place appears clean.

I’ve had about 7 months to think about CCSVI, and today I had about 7 hours to really think about this. Here’s where my mind is now…

There’s a battle going on inside me, other than the battle between MS and my central nervous system, and other than the battle between the anxiety of traveling and the tranquility of my little plastic glass of shiraz. The battle I’m referring to here is between optimism for the events of the coming days, and realism about the prospects.

One part of me has optimistic expectations that this experience could affect my MS in a positive way. I don’t spend much time talking or writing about this part of me. I’m almost ashamed of it. But I must admit that this aspect of my being does exist, because if I didn’t have some level of optimism, I would not have spent hundreds of hours researching this, and I wouldn’t be sitting where I am tonight. This is the emotional, hopeful part of me.

The intellectual part of me is working hard to keep the emotional part of me grounded. My brain keeps telling my heart to guard its expectations. After all, this is an experimental treatment of a condition that is related to MS only theoretically (so far). If I let my hope and my emotions run the show, I could be in for a big disappointment.

So my state of mind is the product of these two warring factions in my head. So far they are fighting to a draw, which is probably a perfect situation from a mental health point of view. A little optimism is good for the soul. A little realism is needed to hedge against the possible negative outcomes.

What are some of the potential outcomes this week?
  1. We could find no problems with my veins. Ironically, healthy veins would be a huge disappointment for me. I’d be back to the drawing board in terms of finding a strategy to fight my MS.
  2. We could find problems with my veins, but be unable to fix them. This is disappointing, but less so than outcome #1. If I know I have problems, I can continue to research options for repairing them in the future.
  3. We could find problems with my veins, and successfully address them surgically. This is the ideal outcome of this week’s work. But even then, there are three possible sub-outcomes (I just made that word up):
    1. The repairs could be permanent, and positively affect my MS (best sub-outcome).
    2. The repairs could be temporary, and re-repair would be required later (next best sub-outcome).
    3. The repairs could be permanent, but have no positive effect on my MS (worst sub-outcome).
What keeps my spirits up is that I’ve been wondering and wondering for so many months, and now I’m that much closer to having answers. Answers are good.

Schedule for tomorrow: MRV and then dinner with friends.
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Wednesday, March 10, 2010

CCSVI- It’s My Turn

(Photo credit: The Fayj)
“There are risks and costs to a program of action. But they are far less than the long-range risks and costs of comfortable inaction.”
John F. Kennedy

I've been posting here for a couple of months about a new theory of the root cause of MS, called CCSVI. I’ve spoken to, called, emailed, blogged, private messaged, posted on message boards, Skyped, tweated, and Facebook chatted with so many people. I did all this to gain a better understanding of the relationship between CCSVI and MS, and I did this to find out what my options were for treatment. I am happy to say that the time for talk is over, and the time for action is here.

I met a wonderful group of MS patients who studied CCSVI even more than I did. They put me in touch with a doctor who is forward-thinking enough to start diagnosing and treating MS patients right now. Most of the folks in this group have already been treated for CCSVI. Now, thanks to them, it’s my turn.

On Sunday, my wife and I will be packing up the wheelchair van and driving to a “far away” hospital to spend a week or so with Dr. X, an Interventional Radiologist and Chief of Radiology at a major hospital. On Monday and Tuesday the 15th and 16th, I'll be going through some diagnostic activities (MRV and Ultrasound). On Wednesday the 17th I expect to have a venogram and angioplasty (if warranted) on the veins that drain my central nervous system. No green beer for me on St. Patty’s day this year. I’m not exactly sure when I’ll be home- probably a couple of days later.

Dr. X asked me to keep his identity confidential, so that he is not inundated with requests that he cannot handle at this time. As soon as I am given the okay to disclose his contact information, I will.

Because many of you are interested in what I'll be going through with this experimental treatment, I plan to blog about the details of my experience on a regular basis -- hopefully at least once per day while I am at the “far away” hospital. 

Although I am very encouraged by the possible connection between CCSVI and MS, I have to be realistic about the chances that this will make a difference in my life. In other words, I am managing my expectations. This is how I operate. Others, in a similar situation, might effuse optimism. To each his own. Perhaps this will slow down or stop the progression of the disease. Maybe it won’t help at all. But one thing is certain. If I do nothing, then I know where this thing is headed.

For some basic information about CCSVI, and its potential relationship to MS, please read my previous posts on the subject.
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Friday, March 5, 2010

My MS Story Chapter 33- The Lesions in My Spine Are Not Simply in My Head

Kayak 02a We all employ coping mechanisms to deal with life’s misfortunes.
“I didn't want that job anyway. The commute was too far.”
“He’s just going through a midlife crisis. He’ll come crawling back to me."
“Although my legs are pretty much shot, at least my upper body works fine."
But what happens when these little stories we tell ourselves don't turn out to be true anymore?

For the first seven years of my battle with MS, there was a clear line of demarcation. I was taking a direct hit in my legs, but my upper body was unaffected. I held my breath. I felt that as long as the disease stayed in my lower body, then I could handle it. I didn't want to think about the possibility of my upper body becoming involved. Instead, I just held my breath.

Then the first signs emerged. I noted this in my journal:

Playing poker with Kim’s parents- seemed to have a little problem shuffling. Seems to be some dexterity issue there.
Not long after, I began to sense more changes:
I think I feel it in my hands a little when I write or type.
The steady deterioration continued. In January of 2009 I asked my employer to purchase a program called Dragon NaturallySpeaking, so that I could dictate to my computer rather than type (I'm using that program right now).

In the spring of 2009, when I took my handcycle out for the first few rides of the season, it became apparent that the problem wasn't only in my hands, but also in my arms. I couldn’t peddle my handcycle nearly as far as I had the previous summer. So, what did I do? I shortened my route, of course.

In May and July of 2009 I made the following observations.

I’ve noticed considerable deterioration in fine motor skills. Left arm/hand worse than right. Noticing that I favor right hand now.

I am noticing continued deterioration in my hands. I have some difficulty manipulating my fork and knife at dinner. Hands feel a bit numb, not like no sensation but rather like no control. I notice it with the remote control as well. It is as if I am manipulating objects while wearing a pair of heavy mittens.
Now things were getting serious. I mean- the remote control?!?! Today I’m relegated to being a right-hand-only clicker operator, which means I can’t be eating or drinking at the exact same moment I’m surfing the 900 channels on my big screen TV. This is a major inconvenience.

Other than handcycling, and channel surfing, I also enjoyed two other pursuits that required upper body strength. Here's what I noticed about those activities in the summer of 2009.

Went for short ATV ride with Zach, down by Carole’s house. I could still drive the thing, but due to arm and hand weakness it is not fun. I’ll keep one ATV for hunting, but won’t enjoy the riding, so will sell the other one.

Went Kayaking for first time this year. Getting in was OK. Could not paddle very far- 10 minutes. Getting out was a job, but I had 4 helpers.
IMG_0045Today, I continue to ride my handcycle, just not very far. I still have the kayaks. I'll probably give that a try again this summer. I’ll just need to make sure there are 3 or 4 people to help me get out of the kayak and back into my wheelchair at the end. I sold both of my ATVs.

I tried not to think about what life would be like if the MS spread to my upper body. Clearly, holding my breath didn't work. But now that I'm here, and now that it's happening, I'm simply dealing with it in the best way that I can. I suppose I could feel sorry for myself, but I don’t…I can’t. It’s just not in me. The sun still rises and sets. I still wake up, enjoy the day, and then go to sleep. I have difficult moments and I have joyful moments, just like everyone else.

As many of you know, I'm inspired by my late mother. She was a quadriplegic with some limited use of her arms and hands (due to an accident, not MS). Her crippled hands had a distinctive appearance that I’ll always remember. In recent months, my own left hand has, when in a particular position or while completing a particular task, looked very much like hers did.

I must admit, given the uncanny way in which my physical condition has grown to mimic hers, I’ve entertained the thought that my entire disability may simply be a psychosomatic emulation of my beloved mother. I wish it were so, because then I could be cured with a handful of visits to a shrink. But, unfortunately, the lesions on my spine are not simply in my head, so to speak.

Postscript: When I look over this post, I have some concerns. I want people to understand- to feel- what I'm going through. I try to be brutally honest. But there are two responses that I hope not to elicit. First, I don't want pity. That's not why I'm sharing my experiences. I still have a wonderful life. Second, I don't want to come off as self-righteous. Just because I am innately capable of dealing with my struggles in a positive way, doesn't mean that I think any less of people who are having a more difficult time dealing with their struggles. After all, my piece of mind is a gift that I have been given, not a mountain that I have climbed, or a merit badge that I have earned.

Tuesday, March 2, 2010

My MS Story Chapter 32- The Conclusion of the Rituxan Epic

I try not to make this blog too depressing. The subject matter is often difficult, yet my life is not cheerless at all. My goal is to be genuine, with just a dash of uplifting. I hope people feel better after visiting here, not worse, or at the very least they become more informed about disabled life. One of these days I'm going to tell a story with a plain, simple, happy ending. But, unfortunately, this is not that day.

Here is a brief recap of what I’ve already written about the Rituxan clinical trial:
Boy meets Clinical Trial
They fall in Love
Trial gives Boy Rituxan; Boy reciprocates by showering Trial with Data
The first year is great
The second year is not great, but still good
Trial forsakes Boy, leaving him wondering, “What did I do wrong?”
Boy strikes out into the cold, hard world, on a quest to recreate what he once had with Trial
Eventually, Boy does find more Rituxan
Boy rejoices!
There. You are up to speed. If you’d like the whole story, please read the previous posts about my Rituxan experience, which can be found here.

After the trial I did find more Rituxan. In September of 2007 I had my first two out-of-trial infusions. We were surprised that the insurance company had covered the $20,000 cost of the drugs. I don’t think they meant to. We caught them snoozing. Due to the confusion around my departure from the trial, these infusions came a full 20 weeks later than they should have come, if I had stayed on the “2 infusions every 6 months” trial protocol. Better late than never though, right?

My third and fourth post-trial infusions were planned for six months later- March of 2008. We followed the same process we had followed earlier to get approval for the two infusions. But this time the insurance company woke up and said, “Wait, this is not an approved treatment for MS. Request DENIED.”

We were prepared for this denial. My doctor and I dusted off the battle plan that we had put together in 2007. The first item of business was to get a letter from the clinical trial administrators indicating that I had been given the trial drug and not the placebo. We strongly suspected this, but written proof would be the crux of our argument to the insurance company. We had data showing that “something” stalled the progression of my MS during the trial period. Now we only needed a document stating exactly what had been pumped into my veins for two years. That’s a reasonable request, right?

I asked the trial administrators for just such a document…an email…some hen scratching on the back of a napkin…anything proving that I had been on the trial drug and not the placebo. My request fell on deaf ears. The study was not yet unblinded. Therefore, this information was under lock and key. March, the scheduled month for my next pair of infusions, came and went- so did April, May, and June. I made phone calls. I wrote letters. While I waited to hear back, more irreversible damage occurred to the myelin sheath around some of my nerves in my spinal cord. While I waited, I accumulated more permanent disability. But, the important thing was that protocol was preserved. That’s what I’ll always remember about this trial. The damn protocol was preserved.

Finally, in July of 2008 I received the written confirmation that I needed.  My doctor and I threw together an appeal package and submitted it to my insurance company for review. In late August I learned that my appeal had been approved. For a period of one year they would reimburse me for Rituxan, a total of 4 infusions, and then they would re-evaluate. I got my next set of infusions in September of 2008, six months later than I should have, if it had not been for the insurance company denial, which was exacerbated by the pharmaceutical company’s hoarding of critical information. Finally, things were looking up, right?

In March of 2009 I had my first “on-time” infusions of Rituxan in a long while. Maybe I was back on track. Maybe I could recapture the magic I had felt during the clinical trial a couple of years earlier. In August of 2009, before I could receive my next scheduled infusions, the insurance company re-evaluated, as promised, and denied me again. My doctor asked me if I wanted to appeal.

I took an objective look at my situation, and I had to admit that Rituxan had not provided me any benefit since the clinical trial had ended. I’d fought so hard for the six post-trial infusions that I had received. But it simply wasn’t working anymore. Was the problem that I’d lost momentum with all the delays? If I had stayed on the trial schedule, with no missed infusions, would the Rituxan have continued slowing my disease progression? I’ll never know.

Rituxan is not a drug anyone should take lightly. It is heavy duty stuff, with potentially harmful long term consequences. Given this, and given its ineffectiveness, I told my neurologist that I’d had enough. For a period of four years, this drug had been my big hope. I’d need to find some other hope now.

My doctor agreed. So the great Rituxan adventure had ended not with a bang but a whimper.

To summarize this last chapter of the Rituxan epic:

breakup Boy finds Rituxan once more after Trial
However, Boy never again feels what he felt with Trial
Boy gives up on Rituxan altogether, and remains drug-celibate for a long, long time
With no treatment, Boy asks himself, “What now?”