MS Study Blatantly Driven by Financial Concerns, Not Patient Welfare

Image by DavidDMuir via Flickr

This is the kind of thing that really gets me pig biting mad. The beneficent overseers of Biogen, makers of Tysabri, announced the commencement of a study (click here for details) that will test the effectiveness of its blockbuster drug vs. two rival medicines.

The study, which will involve 1800 people in 27 countries (wonder how much that will cost?) will pit Tysabri against Rebif and Copaxone, two drugs that have already been shown to be less effective than Tysabri in reducing relapse rates and the appearance of enhancing lesions on MRI studies.

According to the press release, "A significant number of MS patients continue to experience clinical relapses and disease progression despite treatment with disease-modifying therapies such as Copaxone and Rebif. The SURPASS study, a large, well-controlled comparative trial of MS treatments, will evaluate switching to TYSABRI versus staying on or switching between Copaxone and Rebif and determine whether early use of TYSABRI in the treatment algorithm ultimately leads to better outcomes".

In plain English, the study will prove that Tysabri is more effective than Copaxone and Rebif, which is something that we already know (previous studies have shown Tysabri to be about twice as effective as the other two drugs), in the expectation that these results will lead neurologists to prescribe copious amounts of Tysabri to their patients earlier in their disease course. Of course, I'm sure the study results will skirt around the fact that neither Rebif nor Copaxone have potentially deadly side effects, while Tysabri has been linked to the deadly brain infection PML, the danger of which appears to increase with the length of time that Tysabri therapy is continued.

Rebif and Copaxone are immunomodulators, which leave the patient’s immune system intact, and try to redirect it from attacking the patient's own nervous system. There side effect profiles are relatively benign; Rebif leaves some of its users experiencing flulike symptoms, and Copaxone can sometimes induce a short but frightening allergic reaction after it is injected. Tysabri, on the other hand, is a targeted immunosuppressant, profoundly affecting the workings of the human immune system. Granted, the incidence of PML is small, but comparing Tysabri to Rebif and Copaxone is like comparing a howitzer to a handgun.

Please don't get me wrong, Tysabri has been an extremely effective drug that has benefited many, many patients, some of whom will testify that Tysabri dramatically changed their lives for the better. I am not "anti-Tysabri", and in fact, in the fall of 2006 I was on Tysabri, but received no benefit from the drug. My point here is that conducting this massively expensive study will do nothing to advance our understanding of Multiple Sclerosis, nor bring a cure anywhere closer to fruition. This is merely a marketing ploy, an attempt by Biogen to take a bite out of the market shares of Rebif and Copaxone. Might these research funds not be better spent in, say, actually trying to find the cause of Multiple Sclerosis, or to at least develop more effective drugs with less potentially deadly side effects? Apparently not, as it will be more cost-effective for Biogen to simply prove that which has already been proven for PR purposes, rather than do some actual, groundbreaking scientific research.

The obsession with suppressing the immune system of MS patients must stop. I've said this before, I'll say it again, and I'll keep saying it until the jolly men in the crisp white coats throw a net over my head and drag me away to a rubber room, but an aberrant immune system is a symptom of the disease, not the cause of Multiple Sclerosis. Treating MS by suppressing the immune system is almost like treating a broken leg with painkillers. Yes, the symptoms subside, but the underlying cause of those symptoms is left entirely unaddressed. The current assortment of MS pharmaceuticals have definitely improved the lives of countless MS patients, and I am certainly not anti-MS drug. Lord knows, I've been on most of them. Unlike painkillers treating a broken leg, the MS drugs do significantly alter a patient's prognosis for the better, but they do nothing to combat the as yet undiscovered cause of Multiple Sclerosis. I find it incredibly frustrating that billions of dollars are being spent developing drugs to treat MS without actually attacking the disease at its core.

It's high time for neurologists and MS researchers to end of their love affair with the autoimmune theory. There is mounting evidence that the immune response that is now thought to be the cause of MS is actually a secondary phenomenon, and that there is an unknown mechanism killing nerve cells well before the immune system gets involved. A recent study (click here for the abstract) by an Australian MS pathologist and his colleagues examined autopsy brain tissue of 15 deceased MS patients, and found that nerve cell death precedes the involvement of the immune system, which appears to be activated by the damage that some unknown entity is doing to brain and spinal cord tissue (click here for an analysis of this study, provided by The Accelerated Cure Project).

We don't know what nasty process is killing off the oligodendrocytes of MS patients, but studies like the one above show that it most likely is not the patient's own immune system. The cause could be CCSVI (click here for more info), it could be infectious, it could be genetic, or it could be a combination of factors coming together to form a deadly storm of brain cell toxicity. We'll never know, though, as long as research monies are spent to benefit pharmaceutical companies rather than the patients who are beholden to their products.

I think a few of my brain cells just exploded while I was writing this post. Maybe the real cause of MS is the asinine research that is purportedly being done to help patients, but is really designed to line the coffers of the companies conducting that research with cold, hard cash.

Ugh.

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• FDA warns of brain risks with frequent Tysabri use (seattletimes.nwsource.com)

To the Real Heroes...

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I've been surprised, flattered, and humbled by the tremendous response that my recent writings about my "Adventures in CCSVI Land" have elicited. I'm incredibly grateful to everybody who took the time to leave their extraordinarily gracious comments on my posts, or to send me personal e-mails filled with hope and encouragement. The fact that I might serve as an inspiration to anybody seems to me to be the greatest gift in the universe a person could be given, and to all who have taken the time to express such sentiments, I offer my deepest gratitude.

Some kind folks have even used the word "hero" in their correspondences with me. As much as I'd love to have a big "S" emblazoned on my chest, I feel compelled to say that the word hero should be reserved for those who display incredible valor, and who choose to put themselves at risk for the sake of others.

The reality of my situation is that I'm just a guy desperately trying to save his own ass. I've found myself caught up in a raging river, heading swiftly towards a giant waterfall. I'm grasping for whatever handhold I might find, in a frantic effort at self preservation. A hero would be the person who jumped into the river to try to save me, despite the very real danger that they themselves might too be swept over the falls. I had no choice in the matter; real heroes must make the conscious decision to suspend their own survival instincts for the sake of someone else's well being.

Although I'm not a hero, I do live with one. My wife Karen displays, each and every day, the quiet bravery and steadfastness that truly define the word. I was diagnosed just one year after we were married, and in the seven years since, Karen has quite literally been by my side through innumerable treatment sessions and doctors conferences, and suffered with me the long series of raised hopes and shattering disappointments that have defined the course of my disease. Without her, I very well may have checked out a long time ago. I'm stuck with myself and my situation, forced to experience the slow withering away of the "me" I once knew. Karen is here by choice; neither I nor any of my friends or family would have blamed her one bit if at any time along the way she had simply opted out. "In sickness and in health" sounds great in concept, but in practice it's one hell of a promise to keep.

Getting hit with a chronic debilitating disease not only affects the person with the actual diagnosis, but all of those around them as well. Family and friends all feel the concussive force of the disease, which radiates blast waves much like an atom bomb. The patient may be at Ground Zero, but those in close proximity can suffer terribly also, and the closer they are, the more grievous the injuries inflicted. It's not only the patient's life that has been forever changed, but also the lives of all who love and care about them.

The patient, at least, receives all of the attention of the medical community, and most of the sympathy of the world at large. The husband, wife, child, or friend who is suddenly redefined as a "caregiver" is too often overlooked, the tremendous burden they must now bear taken for granted, sometimes even by the patient themselves.

A quick trip through the many Internet MS bulletin boards and forums is all it takes to discover that not all spouses and life partners make the choice to stick around once the disease has bared its fangs. I've read countless heartbreaking tales of MS patients being left by those they loved and trusted, and yet others of spouses and lovers sticking around for a while seemingly to only make the situation worse, offering no support at all but adding guilt and resentment to the cyclone of emotion caused by the disease itself, like ghouls intent on tormenting the tormented.

The MS landscape is littered with the smoking wreckage of lives derailed and dreams shattered, of hearts crushed and realities trampled. I'm blessed to have the support not only of the incredible woman who is my wife, but also of a circle of friends and family who don't deny the reality of my situation, but refuse to let it overwhelm the foundations of their relationships with me. I only wish that every other patient was similarly blessed, as I've known far too many who have been forced to trod this agonizing road alone.

Happily, I've had the pleasure to meet other patients who have their own heroes. People whose spouses, lovers, and families are strong and brave enough to treat them, for the most part, as if the disease had never struck, but also wise enough to know when a helping hand or calming gesture is not only necessary but mandatory. Such qualities are impossible to learn, and it is a special breed indeed that possesses them along with the innate sense of how best to bring them to bear. They might not always know quite what actions to take, or what words are needed, but out of sheer love and devotion can turn potentially embarrassing moments into intensely comical ones, and can make the dehumanizing aspects of a dreadful disease a stage on which to demonstrate the best of what it means to be a human being.

So, I bow my head in praise and thankfulness to Karen and my dear family and friends, and also to Kim, Hilda, Marko, Jordie, Kirsty, Jon, Steven, and Allan, MS partners who I've had the privilege of meeting in the past few months; and to the countless others who I've not met and have never heard of, whose strength, love, and dedication have lightened the load and made the unbearable bearable, whose choice to stay in the game has made the game still worth playing.

These are the true heroes, for the most part unsung, but all worthy of blazing headlines and a most special Medal of Honor.

One Week After Attempted CCSVI Liberation; Oh, What I'd Give to Be Boring...

Image by krazydad / jbum via Flickr

It seems I've spent my entire life being kind of unconventional, a little bit off-center, a person not wildly eccentric but filled with eccentricities. For the most part, my individuality has served me well, and over time I learned how to capitalize on my somewhat funky qualities to stand apart from the crowd, to separate myself from the writhing masses, and eventually to turn my quirks to my advantage.

Now, medically speaking at least, I find I'd like nothing more than to be a screaming bore, a real snooze, the dullest MS patient on the planet. Unfortunately, my tendency to be atypical has carried over to my disease presentation as well, and while it's garnered my case a lot of attention, that attention has not translated into medical solutions or relief from my illness.

From the get-go, my MS was labeled "atypical". As the years have gone by, more and more eyebrows have been raised by those considering my case, until finally this year the National Institutes of Health decided that I most likely don't have MS. Although my primary neurologist (a happily off-center guy himself) isn't as quick to dismiss MS as a likely culprit, he readily admits that I don't fit the profile of your typical PPMS patient. Unfortunately, the oddities of my case have not worked out to my advantage, as none of the traditional MS treatments have been able to lay a finger on my disease, and the myriad of unconventional remedies I've tried have been utterly useless.

So, I approached the radical CCSVI theory (click here to learn more about CCSVI) in a hopeful but skeptical manner. Even though I don't have classic MS, meaning the CCSVI theory very likely might not apply to me, a CT venogram done early last summer showed an area of stenosis very high up in my internal left jugular vein. Upon seeing this, the NIH opined that my disease may be primarily vascular in nature, but wouldn't commit to that judgment, at least not enough to warrant continued exploration of that possibility.

With no other options left to me, I investigated CCSVI and the idea of a vascular genesis to my illness with great interest, and after many months, with the help of a wily group of determined activist MS patients, found my way to Dr. Salvatore Sclafani, the Interventional Radiologist who performed the Liberation Procedure (a venogram and balloon angioplasty) on me last week. Knowing the peculiarities of my case, Dr. Sclafani and I really weren't expecting to find much in the way of vascular abnormalities during the procedure, but once again, I managed to defy expectations.

Upon injecting dye (via a catheter threaded through my vascular system) into my right internal jugular vein, Dr. Sclafani exclaimed, "Wow!", declared that my vein was significantly blocked, and that I did indeed have the condition now called CCSVI (Chronic Cerebrospinal Venous Insufficiency). Terrific, I thought, at long last a breakthrough!

Dr. Sclafani tried to open the blockage using balloon angioplasty. After four attempts, he had only limited success, the vein was only partially opened and most likely would close back down very soon. He also found some stenosis (narrowing) in my azygos vein, but because of its odd location was unable to fix that, either. Another venogram procedure, using different instruments, would likely be able to fix the azygos problem, but my primary problem appears to be my right jugular vein, which, when compared to the left, looks like something a very drunken Jackson Pollock might have painted on an extremely bad day.

So, the doctor and I are now left with the knowledge that I have some serious Central Nervous System blood flow issues, but are extremely limited in our options for rectifying them. The two most likely options would be traditional "cut the neck open" surgery to remove the malformed valve that is blocking my jugular, or to insert a stent into the vein to press that valve open.

Dr. Sclafani consulted about my case with the doctors and researchers in Italy who have been dealing with CCSVI for several years now, and they commented that they had never seen a valve like mine, that high up in the jugular. Once again, my individuality shines through. Hip hip freaking hooray...

The folks over in Italy suggested that whenever they'd encountered a similar jugular malformation, they'd recommend traditional surgery, or possibly a stent, although they generally try to avoid stents, which are exactly the same conclusions to which Dr. Sclafani had come. Dr. Sclafani talked about my case with some vascular surgeons, who didn't think "open neck" surgery would be a good choice, because of the distinct possibility of severe thrombosis (clotting issues).

This all finally leaves us with the stent option, which I am very uncomfortable with. Although several dozen CCSVI patients have been treated with stents, their use in jugular veins is somewhat controversial, for two primary reasons: stent migration, and eventual stent failure.

It's important to remember that the stents being used were all designed and approved for use in arteries, which are anatomically different from veins in extremely significant ways. A stent that gets loose in an artery generally gets pushed only deeper into the narrowing vessel, and doesn't inflict too much damage. A stent that becomes dislodged in a jugular vein, on the other hand, would inevitably find its way into the heart, with disastrous consequences.

My greater concern, though, is eventual stent failure. The stents now in use were almost all designed and approved to be placed in arteries located in the chest cavity, and these arteries are relatively rigid and not subject to much flexing. The stents now in use are constructed to withstand the tremendous pressures generated by the rhythmic pumping of the heart, not the torque, bending, and twisting they would be subject to when inserted into a vein in the incredibly flexible neck. Laboratory tests have shown that stents do indeed fail over time when subject to the kinds of stresses one might expect them to undergo when placed in very pliant jugular veins. The results of some studies suggest that stents placed under such stresses could likely fracture within 10 years. Needless to say, such a failure could be catastrophic.

Dr. Sclafani, ever the inventive guy, is trying to come up with some alternative solutions, and I'm confident that the good doctor will get it all figured out. In the meantime, though, the choice is between going for the stent, and the inherent dangers that entails, or waiting for the development of a unique procedure that would come with no guarantees, either. And all the while, the relentless drumbeat of my disease progression pounds inexorably onward.

Of course, I'll muster the forces and the gear up for the battles to come, but just this once, it sure would be nice to be scintillating dull...

Details on My CCSVI "Liberation Procedure"

Image by Okko Pyykkö via Flickr

Okay, folks, here's the skinny on my experience undergoing the CCSVI "Liberation Procedure", and the results obtained from it. For those unaware of what CCSVI or the Liberation Procedure are, please click here.

On Wednesday morning, March 10, my wife and I arrived at Kings County Hospital promptly at 7:45 AM, quite the improbable feat considering my intense loathing of the early morning hours. The hospital is about a one hour drive from my apartment in Manhattan, so we had a car pick us up at 6:45 AM (egad!). I somehow managed to get some sleep the night before, which was important because I had a long day in front of me.

Since my power wheelchair weighs about 300 pounds, making it impossible to transport in vehicles not specifically designed to handle such contraptions, we had to use my manual chair to get my gimpy ass in motion, which I despise (I feel like it renders me completely helpless). Because of the impending procedure, I had to stop taking the powerful anti-inflammatories that help keep my Avascular Necrosis in check, and the pain in my joints was intense. Riding in the uncomfortable manual wheelchair only made it worse.

Although I was considerably anxious, the trip to the hospital was made gratefully tolerable by our Egyptian cab driver, who was extremely intelligent and engaging. Our conversation allowed me to exercise my esoteric knowledge of ancient Egyptian gods, goddesses, and religious beliefs, which I rarely get to do in the course of a normal day (or week, or month, or decade), and telling tales of Isis, Osiris, and Horus went a long way towards taking my mind off of the potentially momentous events of the day to come.

Upon our arrival at the hospital, we took our place in the pre-op waiting room, and waited. And waited. And waited. I did my best to keep anxiety from taking root, trying some breathing exercises and meditation, attempting to stay in the moment and all that crap I like to spout off about, but still the butterflies kept churning away. We were finally called at 10:30 AM, and Karen and I were led to the changing area, where my godsend of a wife helped me out of my civvies and into the usual flattering hospital garb, complete with shower cap hat and rubber soled socks. We then again resumed waiting, until they finally carted me off to the surgery staging area around noon.

In the staging area, I conferred with some of the doctors and staff who would be assisting in the procedure, and Dr. Sclafani and I once again discussed that our expectations of finding anything significant were rather low, since my disease presentation is so atypical as to call my diagnosis into question , and my initial CT scans showed only one small area of stenosis high up in my left jugular, in an area that would be hard to address. I told Dr. Sclafani that I would prefer that he err on the side of caution, and he assured me that this was his intention from the get-go. I'll take this opportunity to sing the praises of Dr. Sclafani, who is an accessible, compassionate man that strove to make me a full partner in the process, and who respected and answered all of my questions and concerns in a professional but truly friendly manner. In short, Dr. Sclafani a very good man. I'm very lucky to have found myself in the care of some exceptional doctors who are also terrific human beings, including my primary neurologist, Dr. Saud Sadiq.

At about 12:30 PM, I was taken into the operating room, and gingerly made my way onto the operating table, with the help of a nurse and two orderlies. An IV was inserted into a vein in my left hand, and I believe the IV was attached only to a bag of saline, as I don't think I was sedated at all during the procedure. I may be wrong, but if there was any sedation, it was quite mild, as I was awake and alert throughout the entire process.

After sterilizing the location that the catheter would be inserted (my upper right thigh, adjacent to the groin area), I was given lidocaine injections in the area to numb it up in preparation for the catheter insertion. The lidocaine injections stung a tiny bit, but weren't really bothersome. Soon after, the procedure began, and the catheter was inserted into a vein in my upper thigh. The actual insertion was painless; all I felt was pressure and some tugging in the area.

The table I was lying on was integrated into an articulated x-ray machine, which changed position almost constantly as the catheter made its way through my vascular system and into my right jugular vein. Dye was injected into the vein via the catheter, so that blood flow could be tracked via x-ray. When the dye was squirted through the catheter, I could hear it as it filled the vein. Kind of strange, but nothing to freak out about. As soon as the dye filled vein was imaged, Dr. Sclafani literally said, "Wow!", and announced that I definitely had CCSVI. The blood in the right jugular was hardly flowing at all, and was blocked by a malformed, very large valve that was stuck almost shut. This seriously impeded blood flow, and forced blood to reflux back into my brain.

Dr. Sclafani tried to open the valve with a balloon device attached to the catheter, and each time he inflated the balloon it kind of felt like my ears were popping, very similar to the feeling you get in an airplane on final descent. He tried to open the valve three or four times, but with only limited success, and does not expect the valve to remain open for very long.

Next, the catheter was fed into my left jugular, and again dye was injected. This time, the x-ray images showed my blood flow to be perfectly normal, and the blood vessel showed no sign of stenosis.

These are some of the actual images taken during my venogram. The first two images show the abnormal right vein and the normal left vein. Notice all the fuzzy grayness on the left most image (right IJ). those are all the collateral veins trying to drain the right side through the vertebral vein. Unfortunately, even the vertebral vein is malformed and doesn't drain properly. The second image from the left is the normal left side and you can see uniform size and no collaterals. The third image is a close up of the abnormal valve, ( it's the gray area between the two areas of black ). Finally the image on the right is a view of the inflated angioplasty balloon.

The final step in the procedure was to explore my azygos vein, which is located in the chest and drains blood from the spinal cord. The catheter was manipulated into the azygos, and when the dye was injected, a small area of stenosis (narrowing) which was restricting blood flow was detected at the very bottom of the vein.

The azygos vein is a very twisty vessel, with lots of nooks and crannies. Unfortunately, the area of stenosis that was detected in my azygous was located in a very hard to reach part of the vein, and despite numerous attempts with different types of instruments, Dr. Sclafani could not access the site of the stenosis.

At this point, the procedure had already lasted over 4 1/2 hours, and the lidocaine that was used to numb the area of catheter insertion started wearing off. Suddenly, things started to become quite painful. I stupidly tried to gut it out for a while, trying to be the "Zen Warrior" that I like to imagine myself, but after a few minutes I realized I was being a "Zen Idiot" and alerted the doctors to the situation. After a few more lidocaine shots, the pain abated, and the procedure continued.

Trying his best to get at the area of stenosis in my azygos, Dr. Sclafani continued to try different instruments and tools in an attempt to reach the stenosis and balloon it open. This part of the procedure was not very pleasant, as I could feel the catheter snaking around inside my chest, creating an uncomfortable sensation of pressure that made me feel like I was having difficulty breathing. After exhausting his entire bag of tricks, Dr. Sclafani finally had to give up and leave the azygos stenosis unaddressed.

At this point, almost 5 1/2 hours after it started, the procedure was over. The catheter was removed, and pressure was applied to the area in which it had been inserted for about 15 minutes. When it was determined that the insertion point was no longer bleeding, I didn't even need a Band-Aid, and I can't even see where the catheter went in.

I was then wheeled into a room to recover, but since I hadn't been sedated, there really wasn't all that much to recover from. Karen appeared by my side, which gave my spirits an immediate boost.

Dr. Sclafani soon came in to explain his findings, which were that the right jugular was seriously occluded, and that although he tried with limited success to balloon it open, he didn't feel that it would stay open for very long. The options for addressing the abnormal valve that is causing the blockage are either the insertion of a stent, or a more traditional surgical procedure in which my neck would be cut open and the offending valve cut out. Neither of these options is particularly appealing, as Dr. Sclafani and I agree that until stents are designed specifically to be placed in the jugular vein, the risks involved in stenting the jugular are largely unknown and could be considerable. He suggested that the traditional surgical procedure might be the best option.

As for the obstruction in my azygos vein, Dr. Sclafani thinks that there is an instrument that he didn't have on hand during my procedure which he could use to reach the area of stenosis and balloon it open. This obstruction should remain open after ballooning, so we might decide to do another catheter procedure sometime in the near future.

After it was obvious that I had come out of the procedure in good shape, I didn't even need to spend the night in the hospital. Karen and I stayed in a local hotel, so that we didn't have to make the trip back to Manhattan, since we needed to visit Dr. Sclafani again the next morning.

Dr. Sclafani is going to consult with other doctors who are working on CCSVI, and determine the best approach regarding the two areas of abnormality he found in my CNS vascular system but had to leave largely unaddressed. We are still on the cutting edge of medicine when dealing with CCSVI, a theory that is still in its infancy, and there is much that needs to be learned.

In short, the procedure was a "successful failure", in that we successfully determined that I do have significant abnormalities in the vascular system associated with my central nervous system (a very important discovery), but those abnormalities unfortunately could not be remedied during the procedure.

As usual, I just can't seem to do anything "easy". While I now know that I do have significant blockages in my jugular and azygos veins, the scientific community still isn't sure that such blockages could be responsible for neurodegenerative damage such as is seen in my case. It stands to reason, though, that having such significant blockages in blood flow can't be doing me any good, and now that I know that I have these abnormal blockages, I would definitely like to get them fixed.

Dr. Sclafani is going to consult with my neurologist, and, I hope, with the neuroimmunology team that has been tracking my case at the National Institutes of Health, so the coming days and weeks should be filled with some important decisions and revelations.

Stay tuned, I'll keep updating Wheelchair Kamikaze with all of the latest news...

Post on My CCSVI Procedure Coming Soon, I Promise

I know that everybody is waiting for me to post a detailed account of my CCSVI Liberation Procedure, and I've got a full draft ready to go. I'm letting the doctor who performed the procedure look it over, to make sure that everything I stated is factually correct, because I think it's important to get it right.

The post not only goes over the results of the procedure, but gives a blow-by-blow account of what it was like to undergo "liberation". So please stay tuned...

And thanks to everybody who has left such thoughtful comments and sent such lovely words of encouragement. I appreciate your expressions of concern more than words can convey...

Back Home, Safe and Sound

First of all I'd like to thank everybody who left comments and sent e-mails wishing me their best, offering their support and encouragement. I don't have the words to express how much I appreciate the comfort sent my way, and I am continually astounded that my silly little blog has touched the lives of so many.

I'm back home, safe and sound, after undergoing the CCSVI angioplasty procedure, which lasted longer than I expected, almost 5 1/2 hours, and discovered several abnormalities within my CNS vascular system. I'll detail these abnormalities in a later post, when my own understanding of what was found is more clear.

For now, I'll just say that the abnormalities that were discovered were not able to be fully treated at this time. Dr. Sclafani, who performed the procedure, is going to consult with a variety of experts to determine the best course of action to take moving forward.

As for the procedure itself, it really wasn't painful or even all that that unpleasant, just long and tiring. Not that I'd recommend it for a recreational activity, but the degree of anxiety I felt before the procedure was out of proportion to the actuality of the event.

Again, I'd just like to thank everybody for their wonderful show of support. I will post a detailed explanation of the findings after I consult further with my doctors, and can give an entirely accurate account. I expect I'll be able to do this within the next few days. There is surely enough misinformation on the Internet regarding CCSVI and the procedures used to address it without my adding to the confusion.

Again, thanks everybody...

Well, I'm Going for It - Having CCSVI Procedure This Wednesday

Image by nats via Flickr

This Wednesday, March 10, I'm scheduled to undergo a diagnostic venogram, looking for stenosis (narrowing) and/or other abnormalities in my azygos and jugular veins. If any such anomalies are found, they will be addressed via a balloon procedure. The venogram itself involves feeding a catheter from a vein in my upper thigh, through my vascular system, to the veins associated with the central nervous system. In the parlance of CCSVI, this is known as the "Liberation Procedure". (For info on CCSVI, click here)

The procedure will be performed at Kings County Hospital in Brooklyn, New York, by Dr. Salvatore J. A. Sclafani, the Chief of Radiology of the facility. He's also Professor and Chairman of Radiology at the SUNY Downstate Medical School. Dr. Sclafani has a long history of innovation in the field of interventional radiology, and is excited to be at the vanguard of CCSVI research and treatment. He attended the recent CCSVI conference in Hamilton, Ontario, along with all of the acknowledged experts in the field, including Dr. Paolo Zamboni, who developed the CCSVI hypothesis. Dr. Sclafani continues to regularly consult with Dr. Zamboni.

I'm hopeful that the procedure will prove to be of benefit, but I'm also trying to keep in mind the realities of my situation. It's important to understand that my illness is highly atypical. There's much question about my diagnosis, and it's quite likely that what is causing my neurodegeneration is not MS.

The neuro immunology team at the National Institutes of Health has examined me extensively, and has concluded that my disease does not fit any of the diagnostic criteria that are required to label my condition Multiple Sclerosis. They aren't sure what I do have, but one of the possibilities they've talked about is that my disease may be primarily vascular in nature, since a CT venogram done this summer did reveal stenosis very high up in my left internal jugular, unfortunately in a spot that will be difficult to fix. However, Dr. Zamboni has recently expressed the opinion that stenosis high in the jugulars is often secondary to stenosis found lower in the vein, and that addressing the lower stenosis often opens up the upper problem as well.

My primary neurologist here in New York is less convinced that I don't have MS, but agrees that whatever disease afflicts me is highly atypical. I have only one significant lesion, at the very base of my brainstem, which has not changed in size or appearance in the nine years that I've been getting regular MRI imaging. My spinal fluid is clear of O-bands or other evidence of inflammation, and my clinical presentation is at odds with the results of my diagnostic testing. I do have evidence of "autoimmune activity", such as Hashimoto’s Thyroiditis, and some unexplained episodes in my medical history.

As a result of this lack of clarity regarding my diagnosis, Dr. Sclafani and I are unsure as to what Wednesday's venogram will reveal, or that addressing any problems that do show up will have any beneficial impact at all on my condition. If I don't have MS, then the CCSVI theory doesn't even apply to me. However, my disease progression continues unabated, and since I already know that I have stenosis in my CNS venous anatomy, it makes sense to further investigate the possibility that vascular problems may be playing a part in my illness.

Thanks to the diligence and hard work of a very small group of grassroots activist MS patients, who relentlessly sought out physicians who would pick up the CCSVI gauntlet, Dr. Sclafani agreed to look at the available evidence, and upon doing so became convinced that the CCSVI theory has merit and warrants serious investigation. After much study and consideration, he's recently begun performing catheter venogram procedures on MS patients, and has found a high correlation between MS and CNS venous abnormalities. He's addressed these abnormalities using balloon angioplasty, to gently force open the azygos and/or jugular veins of his patients.

I first met with Dr. Sclafani about six weeks ago, and he devoted over three hours to consulting with my wife and me. After first being examined by the hospital’s neurologist, I sat down with Dr. Sclafani to go over the results of the CT venogram that had been done this past summer. The good doctor carefully examined dozens of the images contained in the scan, explaining what he saw in each one to Karen and me.

Since my diagnosis, I've met with some of the most renowned doctors in the land, but have encountered few as empathetic and considerate as Dr. Sclafani. Rather than being talked to, I felt I was being talked with, and Dr. Sclafani responded to all of my concerns and unhesitatingly voiced a few of his own. He was scheduled to go to the Hamilton CCSVI symposium about a week after my appointment with him, and we decided to put off making any treatment decisions until after he attended the symposium and had a chance to consult with the assembled doctors.

Our consultation lasted far longer than had been anticipated, and the doctor’s staff thoughtfully had a car service waiting to take my wife and I home when it ended. Dr. Sclafani personally saw my wife and me out of the facility, then helped me into the car. Other than my primary neurologist, Dr. Saud Sadiq, who is also quite exceptional, I don't know many other doctors who would exhibit such down to earth humanity.

After the Hamilton symposium, Dr. Sclafani contacted me and told me he thought we should move forward with the venogram. His assistant Holly attentively handled all the arrangements, and this past Thursday I went back to Kings County for pre-op testing. Thus far, every step of this process has been handled in a professional, timely, and even (gasp!) cheerful manner. Hopefully, the actual procedure will go just as smoothly...

If I were recently diagnosed, or my symptom profile was more mild, I think I'd wait to see what the coming wave of CCSVI research reveals before undergoing this procedure. The speed with which my disease is progressing, though, makes it not too hard to envision the Wheelchair Kamikaze becoming the Mattress Kamikaze in the foreseeable future, and I'm determined to do everything I possibly can to cut that eventuality off at the knees. Upon my diagnosis, just about seven years ago, I vowed that if this son of a bitch was going to take me down, it was going to take me down fighting, all guns blazing, both fists bloodied, and with bite marks firmly implanted in its skull. This is war, and surrender is not an option.

For those interested in contacting Dr. Sclafani, please e-mail his assistant Holly Barr (ccsviliberation@gmail.com).

Alternative Treatments For MS (LDN and Antibiotic Regimens)

Image by eli santana via Flickr

While CCSVI (the "vascular theory" of MS) has recently grabbed the lion's share of attention as an alternative approach to understanding and treating MS, there are some older "outside the mainstream" theories and treatments that also deserve some attention. While the list of purported MS treatments is long and sometimes quite bizarre (including everything from bee stings to ingesting colloidal silver), there are two controversial treatment approaches that do stand out, both of which have some strong anecdotal evidence to back them up. These two are LDN (Low Dose Naltrexone) and long-term antibiotic therapy.

LDN-Low Dose Naltrexone uses a long approved drug that was originally intended to help heroin and opium addicts kick the habit. In very low doses, the drug Naltrexone is said to have immunomodulating properties, and the Internet MS forums are peppered with patients who claim that LDN has helped relieve their symptoms and halt the progression of their disease.

Naltrexone blocks the opiate receptors in the brain, and is therefore useful in treating people addicted to heroin and other opium-based narcotics. The drug is typically used in doses of 50 mg for the treatment of addiction. When used in much smaller dosages, 3 mg to 4.5 mg, many MS patients report sometimes dramatic benefits from the drug. Patients suffering from other autoimmune diseases, such as Crohn's disease and Lupus also report symptom improvement and disease remission resulting from the use of LDN.

The use of LDN has been shown to increase endorphin production, and critics have said that this increase in endorphins ("feel good" chemicals produced naturally in the body) helps relieve patient's symptoms without actually addressing the core disease.

Unfortunately, Naltrexone is off patent, and as is the case with all off patent drugs, very little money is available to fund full-fledged scientifically valid trials, simply because there is not much profit to be made from drugs that can be bought cheaply as generics. Several small studies have indicated possible benefit. The results of a phase 2 trial on the safety and efficacy of LDN as a symptom relief drug for MS patients was recently released (click here), and "suggests that LDN is safe and may have positive effects on the mental quality of life in people with MS; but no effect on a patient's physical quality of life". I know that there are many patients taking LDN that would vociferously disagree with these findings, and insist that the drug has indeed positively impacted their physical condition.

I tried LDN several years ago, and derived no benefit from it. My disease presentation is very atypical, though, and I hesitate to draw any conclusions based on my experience alone. Since I now take narcotic painkillers to tolerate the avascular necrosis I developed as a result of steroid use, I'm no longer a candidate for LDN therapy. If I weren't on the painkillers, though, I'd probably give the drug another try, based on the positive reports that continue to filter in. For more information on LDN, click here.

Antibiotic Therapy-The use of long-term antibiotic therapy to treat MS is based on the theory that an infectious agent is responsible for Multiple Sclerosis. The two infections most often linked with MS are Chlamydia Pneumonia, and the Lyme disease bacteria B. burgdorferi.

Chlamydia Pneumonia is carried by a large majority of the adult population, and is usually thought to be harmless. Researchers at Vanderbilt University, though, in addition to British physician Dr. David Weldon, have linked CPN with MS in several studies, and have developed a combination antibiotic protocol, taken over a long period of time (usually 12 to 24 months) to combat the infection. This "Vanderbilt Protocol" has gone through many modifications, and is usually taken in conjunction with a wide variety of vitamins and supplements meant to enhance the effectiveness of the antibiotics and reduce any deleterious effects such long-term therapy might have on the body.

Many patients who have undergone the rigorous combination antibiotic protocol report vast improvements in their condition, with some even claiming dramatic improvements in disability levels and complete remission of the disease. Unfortunately, these reports remain strictly anecdotal, as no long-term blinded studies have been conducted to test the treatment protocol.

I tried a Combination Antibiotic Protocol about four years ago, and failed to see any benefit from it. Again, I hesitate to draw any conclusions based on my experiences, because of the atypical nature of my disease. For more information on chlamydia pneumonia, its links to MS, and the combination antibiotic protocol, please visit CPNhelp.org (click here).

Chronic Lyme disease (a tick borne infection) has also been implicated as a Multiple Sclerosis suspect. While quite controversial, some physicians and researchers claim that many cases of MS are in actuality misdiagnosed instances of chronic Lyme infection. It is known that the Lyme bug (B. burgdorferi) can attack the central nervous system, and can cause MS like lesions to show up on MRI scans. Some researchers have found evidence of B. burgdorferi in the spinal fluid and nerve tissue of MS patients, furthering the argument that at least some MS is actually Lyme disease. Standard tests for Lyme can often be inaccurate, and several specialized testing labs have developed protocols much more sensitive to detecting evidence of chronic Lyme infection in patients.

Like chlamydia pneumonia, chronic Lyme disease is treated with long-term antibiotics, in the case of Lyme often given intravenously. For info on Lyme disease misdiagnosed as MS, click here. For general info on Lyme disease, click here.

My personal take on this is that these different theories may in fact all be correct, for different subsets of the MS population. Given the heterogeneous nature of MS, I believe it's likely that what we call MS is probably a collection of related diseases that share common characteristics, each of which might respond to different treatments and therapies. The wide disparity in the effectiveness of current MS treatments from patient to patient could be explained by the fact that MS patients are not all suffering from precisely the same disease. MS is a complex beast, and it could very well be that infectious, genetic, toxic, and vascular issues all play a role in the Multiple Sclerosis spectrum. Unfortunately, there is still much to be learned...