Wednesday, May 13, 2015

Attacked by a Three-Headed Beast

When I first started writing Wheelchair Kamikaze back in 2009 I had very little idea of what these pages might eventually evolve into, but I did know that I didn’t want the blog to take the form of an illness diary, a simple journal of my MS symptoms and day-to-day experiences with the disease. Instead, I wanted to concentrate more on the emotional and perceptual impact of dealing with a progressive crippling disease, of being forced to slowly watch one’s body being consumed from within while trying not to lose one’s head in the process. I also thought the blog would be a good place to share my growing obsession with digging into MS research and my efforts at making some sense out of all that I found.

Having said that, of late my physical ailments have been giving me a pretty good trouncing and I’ve started to feel as though I should probably fill everyone in on the details of my puzzling illness, especially since my increasingly feeling like crap is definitely impacting my ability to keep up with regular blogging activities, particularly so when it comes to responding to the many heartfelt comments, messages, and emails sent by the readers I value so much. I’ve always striven to be extremely open and honest on these pages, and it seems almost disingenuous for me to not directly address my physical state when feeling like crud is taking up so much of my damned time.

I’ve often referred to my condition as “complicated” or “atypical” without going into too many details or explaining exactly what I mean. So, here’s what’s been going on with me physically, in all its glory. My body seems to be under attack by a three-headed beast, a triple whammy that these days has me wondering just who the hell I’ve pissed off.

First up there’s my neurologic illness, which just keeps whacking away at me, and of which I’ve written about most often on these pages. My preferred name of this slice of my physical mess is “creeping paralysis”, which is actually an archaic moniker for multiple sclerosis and other progressive neurologic diseases from back in the 19th century. Although I present symptomatically very much like a patient with progressive MS, many of the doctors I’ve seen have been hesitant to definitively label me as having multiple sclerosis since almost all of my test results defy the accepted diagnostic criteria for the disease.

Foremost among the odd aspects of my illness is the fact that I’ve only ever had two central nervous system lesions, neither of which have ever shown any signs of active inflammation: a tiny one in my brain and a much larger, more invasive and troublesome monster located at the very top of my cervical spine, at the critical juncture between my spine and brainstem. I’ve been told that this lesion is so invasive that it’s almost like having my head cut off.

These two lesions haven’t changed one bit or been joined by any others in the 12 years since I first exhibited the telltale limp that eventually led to my initial diagnosis, yet my physical condition has gone straight downhill ever since. In fact, this duo of destruction even show up fully formed on a set of MRIs done to get a look at my pituitary gland back in the year 2000, a full three years before I started limping. At the time these images were first made these lesions were completely overlooked, until they were discovered with much surprise by the doctors at the National Institutes Of Health while they were going over every MRI image I’d ever had done as part of a comprehensive effort to determine just what it is that ails me, a goal neither they nor any other physician has ever able to satisfactorily complete. So, I’m left with a diagnosis of “atypical PPMS”, and I’ve come to grips with this by insisting that in my case those initials stand for the “Peculiar Paralysis of Marc Stecker”.

Whatever you want to call it, my neurologic illness has been anything but kind. It’s left my right side almost completely useless, the muscles in my hand, arm, and leg withered and twisted. Most of the time my right hand is curled into an emaciated claw, an appendage that would look more at home on a mummy than on a living human being. My right side is becoming increasingly impacted as well, getting weaker and less able almost by the day. At times it seems I can just about watch the muscles in my left arm and hand melt away, and with them any remaining semblance of normalcy in my life. Throw in most of the other goodies that come with neurologic illness, such as spasticity, numbness, tingling, immense heat intolerance, and bladder and bowel issues, and the toll has been staggering.

But that’s but one tine of a three-pronged assault on my physical well-being. I also have a wide range of endocrine problems, most likely due to a severely dysfunctional pituitary gland. The pituitary is the human body’s master gland, sending out chemical signals that regulate hormone production in all of the other glands that make up the endocrine system. Because my pituitary is on the fritz – likely because of some kind of autoimmune attack – I experience a wide variety of hormonal deficiencies, some of which if left unchecked can be just as debilitating as my neurologic issues. Among other hormonal abnormalities, I suffer from low testosterone, low cortisol, and low thyroid levels. Although I take various supplements and medicines in an attempt to make up for these deficits, my endocrine system is balanced on such a razor’s edge that if anything goes awry my overall symptoms often get magnified tenfold and I’m left in a vortex of physical despair.

Lately it seems that my thyroid levels have gone completely out of whack, leaving me tremendously weak and fatigued, and overall feeling severely unwell. I’ve lost about 25 pounds in the last three or four months, most likely due to endocrine issues and hopefully not because of something more ominous. Endocrine abnormalities can often result in muscle weakness and even muscle wasting, and could account for the fevers that attack me nightly, making it difficult to figure out which symptoms are caused by my neurologic stuff and which might be attributed to my hormonal problems or some as yet undiscovered culprit.

The complicated interplay of my progressing neurologic illness and increasingly abnormal endocrine system makes me an extremely difficult to treat patient, a puzzling jumble that regularly leaves my doctors at a loss, though I give them lots of credit for working hard at trying to figure me out. I often have completely unexpected and sometimes disastrous reactions to medications, and even minor surgical procedures like biopsies or oral surgery can leave me flat on my back for weeks because my hormonal deficiencies leave my body with very little capacity to heal itself. My endocrine issues are insidious, always at work just below the surface, hiding behind and sometimes exacerbating the symptoms caused by my neurologic illness. This forces my physicians to treat me with kid gloves, always aware of the fact that my strange brew of ailments can sometimes turn typically benign treatments into nasty surprises.

The last but definitely not least of my medical challenges is the constant and often excruciating pain inflicted on me by a condition called avascular necrosis, which has attacked my shoulders and hips. Avascular necrosis (AVN, sometimes also referred to as osteonecrosis) is a disorder that causes the bones in afflicted joints to quite literally die, leading them to eventually crumble and break. Although the precise cause of AVN is not understood, the condition is known to be a very rare side effect of steroid use, and it first manifested in me about six months after I had gone through a 10 day course of IV steroids meant to curtail my rampaging neurologic symptoms back in 2006. It’s now thought that I may have been more susceptible to developing AVN because of all of my endocrine issues – the extent of which we weren’t aware of at the time – and the fact that my body was chronically deficient of the natural steroids a healthy endocrine system produces.

These days, roughly 8 years after those ill-fated steroid treatments, I’m left with the equivalent of two broken hips and two broken shoulders, and all of the attendant excruciating pain that goes along with them. I’m pretty good with words, but I’m at a loss to convey just how agonizing this condition can be. On really bad days, which of late have been occurring with increasing frequency, whenever I try to stand or otherwise put weight on my hips the bones beneath my skin can be heard loudly and horrifically popping, cracking, and crunching as they collapse into each other, sounds often accompanied by my own involuntary yelps and howls. My wife Karen often bears witness to these horrific auditory fireworks, and the look of dismay that shows on her face is heartbreaking.

Chronic, intense pain subverts every aspect of life and commands absolute attention, shackling its victims to moments of utter despair. Through the years I’ve learned at times to affect an almost dispassionate demeanor about my neurologic and endocrine problems, temporarily divorcing myself from the situation and taking on the role of observer. The ghastly pain caused by the AVN allows no such contrivances. I now fully understand why they say torture often doesn’t work during interrogations; there are moments in every day when I would readily admit to killing John F. Kennedy if it would just make the pain stop for even just a few moments.

Avascular necrosis is the leading cause of hip replacement in the United States. Unfortunately, due to my neurologic and endocrine issues I’m not a candidate for surgery as I very well might not survive the procedure, and even if I did I wouldn’t be able to do the requisite rehabilitation afterwards. For many years a powerful anti-inflammatory drug called diclofenac helped keep my pain levels tolerable, but over the last several months it has been discovered that the drug was degrading my kidney function so I was ordered to stop taking it. I’ve tried other anti-inflammatory compounds in its place, but most seem be as effective as sugar pills. I’ve been on and off of a variety of powerful painkillers, from oxycodone to Dilaudid to methadone, but even these potent narcotics don’t help all that much and I despise the way they cloud my mind. I see a very sharp and creative pain management doctor, but there’s only so much she can do. The bottom line is I must try to get through my days with two broken hips and two broken shoulders, in addition to my omnipresent and progressive neurologic and endocrine problems.

So, there you have it, my triple whammy, a triumvirate of infirmities any one of which could be absolutely incapacitating in its own right. The fact that I suffer from all three simultaneously and that they form a three-headed beast that magnifies the power of each sometimes leaves me wondering if I might have somehow been hexed, the victim of some ancient curse. I do my best not to indulge in too much self-pity and try to remain as productive as possible, even if lately that hasn’t been very productive at all. At times, though, the reality of the situation crashes through all of my defenses and leaves me shaking my head, wondering just what the hell happened.

Still, each day the sun rises anew, and as long as I’m on this side of the grass I figure I might as well get on with it as best I can. I’ve always vowed that if these things take me down they’ll take me down swinging, but with so many targets to swing at it’s hard to know precisely where to aim. Especially when taking a swing with a weakened, emaciated, and agonized arm doesn’t amount to all that formidable an attack.

I can still spit with the best of them, though, and if that’s going to be the only weapon left to me, then spit I will. Ha!

On a much more uplifting note, the healthcare website has named Wheelchair Kamikaze one of 2015’s best MS blogs. I thank them profusely, and urge readers to click on the badge below and check out some of the other blogs that made the list. Lots of  great stuff being put out by MS bloggers these days , each with their own unique take on life with multiple sclerosis…

multiple sclerosis best blogs badge


Sunday, April 26, 2015

Glimmers of Hope for Progressive MS: Human Stem Cell Trial, Biotin Study Both Show Efficacy

Progressive multiple sclerosis is a particularly horrendous and intractable illness. Unlike the relapsing remitting form of the disease, for which there are currently 12 approved treatment options (however imperfect these may be), there is tragically little available for progressive MS patients (one very flawed treatment option for SPMS and none for PPMS). At the recent American Academy of Neurology meetings, held last week in Washington DC, some rays of hope for progressive MS finally shone through, among them studies done on honest-to-goodness human progressive MS patients – as opposed to those done on mice or in test tubes – that show particular promise.

As I’ve written about extensively (click here ), the Tisch MS Research Center of New York is currently conducting the only FDA approved regenerative human stem cell trial on MS patients in the United States. Yes, this is the very same study that the National Multiple Sclerosis Society has repeatedly refused to fund (click here). Though this phase 1 trial is not yet complete, interim results were released at the AAN meeting, and they look impressive.

The Tisch Center utilizes a unique approach to using stem cells to treat MS, quite unlike the techniques used in previous regenerative stem cell trials or the stem cell treatments being offered by for-profit operations scattered around the world. Employing proprietary methodology developed in the Tisch Center’s research laboratories, raw mesenchymal stem cells – harvested from each patient’s bone marrow – are transformed into stem cells specific to the human nervous system, called neural progenitor cells. The 20 patients enrolled in this early stage trial will each receive three spinal (intrathecal) injections of neural progenitor cells, spaced three months apart. The interim results released last week report on the nine patients who have thus far begun treatment (click here).

Of these nine patients, seven displayed some form of disease improvement. Six of these seven patients suffer from SPMS, and one from PPMS. Based on neurologic exams, five of these seven patients displayed improved motor functions, including better balance, increase muscle strength, and improved ambulation. Six of the patients reported better bladder function. No significant adverse events were reported. Here’s a graphic detailing the Tisch Center stem cell trial results on a patient by patient basis, taken from the poster presented at the AAN meetings. To view the full poster, please (click here).

While exciting, it’s important to keep these results in perspective. We’re looking at a very small patient population taking part in an early phase 1 trial whose primary endpoint is establishing the safety of the treatment. That said, given the intractability of progressive MS, seeing any significant improvement is extremely encouraging, and these early results certainly validate the approach to regenerative stem cell therapy being taken by the Tisch Center.

Alarmingly, though, the Tisch Center is now facing a fund-raising crisis that threatens to impede the phase 2 extension of this study, as well as much of the other groundbreaking MS research currently underway in the Tisch laboratories. In previous posts I’ve expressed my extreme distress at the NMSS’s repeated refusals to fund research being done at the Tisch Center, and due to unforeseen circumstances the Center’s funding shortfall is now being felt quite acutely. The animal research laboratory used by Tisch Center scientists is being closed as a result of the sale of the hospital in which it’s located (only a block away from the Tisch MS Center), leaving the Center with no viable alternative other than constructing their own facility, which will require a massive fund-raising effort.

Since I’d rather this post concentrate on the research itself, I urge all readers to click here for more information regarding this fund-raising crunch, and to spread the word far and wide. While the Tisch Center is actively conducting the only current FDA approved MS stem cell trial on human beings, the NMSS funds preclinical stem cell experiments being done in test tubes and on mice that, even if spectacularly successful, won’t reach MS patients for more than a decade. Just saying…

(Full disclosure: I am a patient at the MS clinic directly associated with the Tisch MS Research Center of New York, and my MS as well as other physical ailments have been totally kicking my ass lately. So, yeah, I might take this crap just a wee bit personally.)

Another much-anticipated study presented at last week’s AAN conference provided yet more hope for progressive MS patients, though perhaps not as much as originally anticipated. The French pharmaceutical company MedDay released the results of a stage III clinical trial involving the use of massive doses of Biotin to treat patients with Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS).

Biotin (vitamin B7, also known As Vitamin H or Coenzyme R) has been used in much lower doses as an over-the-counter “nutraceutical” supplement to treat brittle hair and nails, some skin conditions, and neuropathy brought on by type II diabetes, among other applications (click here). Biotin is known to be necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids (click here).

A small pilot study researching the use of high doses of Biotin to treat MS was conducted by MedDay starting in 2013. This initial study produced astounding results, with 91.3% of the 23 progressive MS patients involved displaying improvements in their neurologic condition (click here). This small, unblinded, non-placebo-controlled trial created much excitement, leaving patients and researchers awaiting the results of a much larger placebo-controlled phase 3 trial, which was completed in late 2014. The results of this phase 3 trial were presented at the AAN conferences on Friday, April 24, 2015.

In this late stage study, conducted at 19 centers around France, patients were given 300 mg of Biotin per day, which is the equivalent of approximately 10,000 times the maximum daily recommended dosage. The study involved 154 patients, 103 given Biotin and 51 given a placebo. The results of this study (click here), while positive, don’t appear to be nearly as compelling as had been anticipated based on the early pilot study results.

The results of MedDay’s late stage study revealed that after 12 months, 12.3% of the Biotin treated patients displayed a verified improvement in disability scores, as opposed to 0% of the placebo group. Secondarily, 4% of Biotin treated patients displayed disease progression after one year, versus 13% in the placebo group. Very few adverse events, all considered non-serious, were reported. While these numbers pale in comparison with those seen in the initial pilot study, they still represent a breakthrough of sorts in treating advanced progressive MS, which thus far has defied almost all attempts at treatment.

Looked at another way, about 1 in 8 patients treated with Biotin saw their disability scores improve, while 1 in 25 saw their disease progress. Interestingly, only 1 in 8 (I’m using ballpark figures here) untreated patients experienced disease progression. While these aren’t the kind of results many hoped for based on the early Biotin study results (9 in 10 patients experiencing neurologic improvement), they are still better than nothing, which is what mainstream medicine currently offers patients with advanced (non-relapsing) progressive MS.

Given these factors, many patients with progressive MS (myself included) have expressed great interest in giving Biotin a try, especially since the stuff is readily available in over-the-counter form. The highest dose capsules commercially available are 10 mg, meaning that a patient would need to take 30 capsules a day to replicate the doses used in MedDay’s trials, which administered 100 mg of biotin three times a day. There are a few serious problems with this approach, though, above and beyond the huge amount of capsules that would need to be ingested to replicate the doses used in MedDay’s trial.

First, the compound used in the MedDay trial is a highly concentrated and purified pharmaceutical grade form of Biotin called D-Biotin, a stereoisomer of Biotin that is extremely bioavailable (easily absorbed by the body) and contains active enzymes (click here). This type of Biotin is generally not available in over-the-counter capsules. Second, over-the-counter nutraceuticals are completely unregulated, and it’s almost impossible to know the purity of the compounds contained within the capsules or what other ingredients might also be present. One study found that a shocking one third of herbal supplements tested contained not a trace of primary ingredient the listed on the bottle (click here)! Additionally, some Biotin supplements contain calcium, which if taken in greater amounts can cause hypercalcemia, a potentially very serious medical condition (click here).

After consulting with a naturopathic physician, I'm looking into procuring ultra high grade, USP certified (click here) D-Biotin from a reputable wholesaler and having it put into properly dosed capsules through a compounding pharmacy (I'm doing this with my naturopath's help, of course, and will need a prescription in order to get the drug). While this approach is likely to be much more expensive than using over-the-counter product (probably about $300-$400/month), it will offer the best chance at replicating MedDay’s trials, and would certainly eliminate the vast uncertainties involved in consuming huge quantities of over-the-counter nutraceutical supplements.

So, there you have it, two clinical trials targeting progressive MS in very different ways, but coming up with encouraging results to one degree or another. While the Tisch Center stem cell therapy is still in early trials and is at least several years away from moving from the experimental stage to general clinical use, MedDay’s Biotin compound should be ready for FDA approval by the end of this year, and highly motivated patients might try to get a head start on things by taking matters into their own hands. Although the results of MedDay’s late stage phase 3 trial were a bit underwhelming, they do represent an important advance over the status quo, and many progressive MS patients are well past the “any port in a storm” stage.

As mentioned above, though, please take caution if you plan on going the over-the-counter Biotin route. Here’s a video featuring the terrific John Oliver explaining in his usual brilliant and sardonic fashion the pitfalls and perils of placing your trust in the nutritional supplements industry. If you are planning on trying over-the-counter biotin in the quantities required by the MedDay trial, this is an absolute must watch:

Monday, April 13, 2015

A Stranger in Strange Lands

Way back in the summer of 1989, just about a month before my 26th birthday, I unintentionally found myself living in South Florida. An unfortunate confluence of bad decisions on my part, ill will on the part of others, and an ample dose of plain old rotten luck landed me in an environ in which I never intended to land. Without getting into the gory details, suffice it to say that for me Florida was a refuge of last resort, a place I had visited fairly often (I’d long had family living there) but one which I’d never even considered a spot in which I might one day actually reside. In fact, if asked just a few months before if my living in Florida were even a remote possibility, I would have looked at the questioner as if they were totally insane. I knew on a very basic level that the Sunshine State and I would never make for a comfortable fit, but lo and behold, there I was, an accidental Floridian, ill-suited to the place by any number of measures.

Now, there’s nothing inherently wrong with South Florida; some people find the locale a paradise. I’m just not one of those people. Before arriving in Fort Lauderdale I had spent my young adult years living a quirky Bohemian existence, primarily in Boston but also for a short time in my native New York City. I’d never held a full-time job and had inhabited an eccentric and lively subculture of writers, artists and musicians, or at least wannabe writers, artists and musicians, that formed what sociologists refer to as an urban tribe, with its own customs, values and interests that quite often veered significantly from those of the mainstream.

In both Boston and New York such enclaves were woven into the fabric of city life and like-minded spirits abounded. Fort Lauderdale, though, held little in the way of such a community. Either by nature or nurture (or both) I was temperamentally completely at odds with the place. Whereas I’d always deeply appreciated the muted beauty of a cloudy day, Florida exalts in its status as The Sunshine State. Fort Lauderdale is renowned for its beaches; I detest the feeling of sand between my toes. If Florida is Ying, I am Yang. Despite Zen ideals, this particular combination of Ying and Yang did not produce harmony, but instead a feeling inside me of perpetual discord that eventually led to a crisis of spirit.

Despite my ongoing sense of otherness I remained in Florida for about 10 years, a fact I still have difficulty reconciling, particularly to myself. When I arrived in Florida I was pretty much out of options and had hazy plans of staying maybe 6-12 months. And then I suppose life just took over. I halfheartedly stumbled into my first ever full-time job, working as a low-level video producer for a local cable television company, a quirky enough position in which I had lots of fun but made very little money. In spite of my always feeling like a piglet among puppies I eventually managed to fashion an active social life and find friends and lovers, and though I grew extremely close to some of them, many were quite different from the folks I naturally gravitated to up North. This taught me a lesson that remains one of the few net positives that I took away from my time in Florida: to not prejudge people based on externals alone. Given half a chance, people of all stripes can be full of delightful surprises.

After a few years, my oddball job working for the cable company led to a more lucrative and much more structured position in a marketing company, and that to yet another career builder in an even more stifling corporate environment. While this evolution provided financial comfort, it also shoehorned me into a day-to-day lifestyle that only a few years earlier I had adamantly and vociferously forsworn. At times I barely recognized the clean-cut young man knotting a necktie who looked back at me in the mirror, feeling as if I were living a life deep undercover or, worse yet, as a feckless imposter. Beneath the surface my native eccentric impulses still simmered, but somewhere along the line I had allowed myself to become a passionate man living a passionless existence.

Along the road to this begrudging semi assimilation I lost track of who I once was, the essence of “me” that existed still at the core of my being. This created a spiritual and psychological void that led to terrible cognitive dissonance, manifesting as what I can only describe as a desiccation of the soul. As the years wore on I grew increasingly discontented but found myself caught in a self-imposed catch 22, shackled by the responsibilities of the very lifestyle that was causing me such massive dissatisfaction. The mental blinders I developed in a misguided attempt to stay the course served also to keep me from seeing a way out.

During my last few years in Florida I started experiencing a variety of strange physical symptoms that subsequently turned out to be a subtle presage of the physical crisis to come. Finally, after nearly a decade, the breakup of a long-term romantic relationship provided me with some long overdue escape velocity and I made my way back to New York. Despite the tropical beauty of parts of South Florida, my favorite view of the place turned out to be the one in my rearview mirror.

Arriving back in New York felt like pulling on a favorite pair of well broken-in jeans, once thought lost but happily rediscovered. Before long things started to almost magically fall into place; I reconnected with dear old friends, landed a promising high profile job in a very prestigious but funky outpost of a worldwide mega-media company, and, just a little over a year after returning to NYC, met the marvelous woman who I would eventually marry.

Things seemingly couldn’t have gone much better until – after four years back in New York and just weeks before my first wedding anniversary – the nagging physical symptoms that began back in Florida finally became too pronounced to ignore and I was soon diagnosed with progressive multiple sclerosis. Even though I’d had a sense for years that things weren’t quite right physically, nothing could have prepared me for the maelstrom that would soon erupt within and around me as I was forced into the world of creeping paralysis, once again a stranger in a very strange land, limping down a path for which no roadmap existed. My discarded crisis of spirit was now replaced by a crisis of body.

Despite the best efforts of me and my doctors my disease progressed quite rapidly. Less than four years after my diagnosis I was forced to quit work and go on long-term disability. About a year and a half later I found myself in a wheelchair, the right side of my body withering and my left side beginning to weaken. Quite unexpectedly, these developments allowed parts of me that had been buried for decades to take root and blossom. The gaping holes in my life left by the excision of work and social obligations were soon filled by pursuits and passions that had for far too long been subjugated by the realities and responsibilities of adulthood. Further, my attempts to save my own backside by learning as much as possible about my disease and the ongoing research into treating it injected a sense of purpose and glimmer of light into this murky and frightening new world.

Not to say that my getting sick was in any way fortuitous or – gack! – a blessing. But my increasing disabilities served to strip my life bare as I became less and less able to utilize the trappings of the land of the healthy, rendering an ever-increasing list of everyday objects little or no use to me, luxuries and perceived necessities that had served not too long ago as balms providing superficial comfort and satisfaction, particularly during my wayward days lurching through life in South Florida.

Slowly a curtain of artifice began to lift, and looking at the healthy world from the outside in revealed the synthetic nature of the forces driving most people’s lives; the unappeasable wants and desires conjured by insatiable consumerism, the intentional discontent fostered by a social order that thrives on keeping its populace in a perpetual state of simmering dissatisfaction. During my Florida days these machinations led me down a primrose path, but in my increasingly compromised physical state I began to see with startling clarity that the frenzied world of imposed needs and longings that I once inhabited depends on no thing – no object, person, or sense of self – ever being good enough. No wonder antidepressants are being gobbled by the ton.

Paradoxically, the crisis of body that came all too soon on the heels of my Floridian crisis of spirit allowed that spirit to take root and blossom, freed by unfortunate circumstance to flourish in the absence of any preconceived notions of success and failure. Perhaps the most maddening aspect of this creeping paralysis is that it very likely will never allow me to fully utilize the lessons learned, to put into action in that ever receding land of the healthy the bits of wisdom and insight garnered by being forced to endure what I once believed to be unendurable. Has the experience of prolonged debilitating illness left me unsuited for a life back among the healthy? Now there’s a problem I wouldn’t mind facing, to once again be a stranger in that strange land.

As for the world I now occupy, this truly bizarre land of multiple sclerosis, I intend to always be a stranger within. Although so many of my fellow inhabitants are among the most inspiring people I’ve ever come to know, I will not – I cannot – accept citizenship in this nation. If I was haphazardly thrust out of my element by my never intended move to Florida, I’m a willful alien in this place. No MS green card for me, thank you.

And so I find myself a stranger in two strange lands, the worlds of the sick and the healthy. Maybe it was my destiny to always be the stranger, or perhaps I’m just strange. In either case, vive la diffèrence!

Well, just as long as I don’t have to vive it in Florida…

Monday, March 23, 2015

Bits and Pieces: Short-Term Memory Edition (including MS drug news, restless genitals, natural remedies, Oscar Wilde, ancient viruses, and nauseating MS studies)

(For those readers who receive these posts via email, the following contains lots of multimedia eye and ear candy that can’t be accessed via email. I wouldn’t want you to miss out on all of the good stuff, so (click here) to view this post on the Wheelchair Kamikaze website)

Over past year or so, I felt like I was experiencing lapses of memory and that I just wasn't as mentally sharp as I used to be. Although my disease continues to decimate my body, it has pretty much left my mind alone, and I thankfully haven’t previously suffered from any of the cognitive difficulties that plague so many of my fellow MSers. Slowly, though, I started feeling kind of foggy, and began worrying that I was showing signs of CRAFT (Can't Remember A Freaking Thing). After fretting about this for a few months, I brought my concerns to my neuro, who ordered a battery of cognitive tests done to check my mental capacities. I subsequently did an intense four hours of cognitive testing, and received the results last week. Happily, everything checked out okay, and when compared to cognitive testing that I had done back in 2005 the results were practically identical. So, I guess those short-term memory problems were all in my head (pun intended). What a relief!

Over past year or so, I felt like I was experiencing lapses of memory and that I just wasn't as mentally sharp as I used to be. Although my disease continues to decimate my body, it has pretty much left my mind alone, and I thankfully haven’t previously suffered from any of the cognitive difficulties that plague so many of my fellow MSers. Slowly, though, I started feeling kind of foggy, and began worrying that I was showing signs of CRAFT (Can't Remember A Freaking Thing). After fretting about this for a few months, I brought my concerns to my neuro, who ordered a battery of cognitive tests done to check my mental capacities. I subsequently did an intense four hours of cognitive testing, and received the results last week. Happily, everything checked out okay, and when compared to cognitive testing that I had done back in 2005 the results were practically identical. So, I guess those short-term memory problems were all in my head (pun intended). What a relief!

Right then, now that we’ve established that I’m just a sharp as ever, I offer my latest anthology of MS news and info that has caught my attention over the last few months. It’s been quite a while since I’ve done a Bits and Pieces post, so there’s lots and lots of stuff to go over. So much so that I’m leaving out all of the recent research that’s been released regarding HSCT, the extremely promising stem cell therapy that “reboots” the immune system. I’ll do a separate blog post on HSCT in the next few weeks, as it looks like HSCT just might radically change the MS treatment landscape. In the meantime, what follows may be kind of lengthy, but I’ll try to keep it as entertaining as possible and provide you with lots of multimedia distractions. So, let’s have at it…

♦ I first wrote about the iConquerMS program a few months ago (click here), and I’d once again like to urge all MS patients to sign up and take part in actively helping to kick MS's ass (click here). IConquerMS is a patient driven research project designed to use data collected from thousands of patients to compile information about those patients’ disease history, treatment experiences, and family background so that researchers can glean new insights into the wild world of multiple sclerosis.

I like to think of the project like this: if you imagine MS as a huge jigsaw puzzle made up of millions of pieces, and each patient a single piece of that puzzle, it's easy to see that looking at only a few pieces of the puzzle at any one time would give you very little chance of figuring out what picture the puzzle makes when all the pieces are fit together. While it might be impossible to collect every single piece of this immense puzzle, grabbing a significant chunk of them would give you a much better shot at discerning the picture as a whole. Likewise, iConquerMS aims to collect data from at least 20,000 patients to give researchers a chance to glimpse as big a piece of the MS puzzle as possible. Additionally, patients who sign up at the iConquerMS website can take part in member forums where they can submit research ideas and give their opinions on a variety of MS related topics. The project is being facilitated by The Accelerated Cure Project (click here), one of my favorite MS nonprofit research organizations, so you can be confident that all data will be anonymized and the identity of any individual patient will be kept confidential, and that none of the info will be sold or otherwise put to nefarious use. So, please, please, please, pretty please, sign now up to take part in iConquerMS  (click here).

♦ Now, a peek into the always warm and fuzzy world of MS drugs (insert dripping sarcasm here). Although I started out quite critical of the MS Disease Modifying Drugs (DMDs), through many years of interacting with hundreds of MS patients and reading study after study I now understand that these drugs (especially the newer generation drugs, like Tysabri) can at the very least dramatically increase the quality of life of many of the patients who take them. They are far from perfect, and none of the current MS drugs do a lick to cure the damned disease, but I've learned that you have to go where the science leads you. No patient should be satisfied with the MS status quo, which more and more focuses on treatment rather than cure, and all of the newer generation multiple sclerosis drugs carry with them worrisome potential side effects and a whole set of unknowns regarding the effects of long-term treatment, but at this point I don't think there can be any arguing their beneficial impact on many of patients who choose to take them. I personally feel that the effectiveness of these immunosuppressive drugs has led researchers to take their eye off of what should be the real target, finding the ultimate cause of the disease, but that's a subject for a different day. Here then is a mixed bag of some of the newest research info on MS drugs, both good and bad.

It seems that ever since the first MS drugs were introduced back in the mid-1990s there has been an ongoing debate as to whether or not these drugs actually alter the course of the disease, or if they merely mask symptoms while underlying disease progression chugs along unabated. Through the years a multitude of studies have been published supporting both sides of the argument, some saying that the drugs do slow disease progression while others offer completely contradictory evidence. The latest study to look at this issue comes out of Sweden, using a large database of Swedish MS patients who were diagnosed between 2001 in 2005. This study finds that early treatment with disease modifying drugs does indeed slow disease progression (click here). And though the Swedes seem to be among some of the world’s most trustworthy people and – perhaps more importantly – they make some damned good meatballs, I’m sure this won’t be the last word on the subject. It does appear, though, that there is a growing mountain of evidence that supports the notion that early, aggressive treatment may be a vital component in keeping the MS beast at bay, at least for folks with RRMS.

As many patients are keenly aware, Tysabri is among the most effective MS drugs available, but the treatment comes with some troubling potential side effects. Chief among these is PML, a horrendous and often fatal brain infection caused by the JC virus. Although the JC virus is quite common in humans, infecting between 70%-90% of the general population (click here), the immune system typically keeps the virus in check. However, the same immunosuppressive properties that makes Tysabri so effective in combating MS can also allow the JC virus to become active and lead to PML. Since Tysabri became widely available to the public in 2006, neurologists have attempted to reduce the risk of PML by carefully monitoring patients for the presence of JC virus antibodies in their blood, and these efforts have lessened the dangers associated with Tysabri treatment. For patients currently on Tysabri or considering starting the drug, the folks at the Barts and London Medical School in England have come up with a web-based “PML calculator” (click here), which should help patients assess their chances of getting the dreaded disease by simply answering a few questions. I did some quick hypothetical calculations using this web-based gadget, and found that patients who aren't infected with the JC virus have a 1 in 10,000 chance of developing PML. In other words, for these patients, the risk of PML is very, very small, about .01%. On the other end of the spectrum, though, patients who are JC virus positive, who have previously been on immunosuppressive treatments, and who have been taking Tysabri for between two and four years have a 1 in 89 chance of developing PML. Not so good. In addition to the PML calculator, the page also includes information on the effectiveness of Tysabri, and I’d encourage anybody interested to take a look.

Now, some good news about Tysabri. A recently released study shows that in addition to the drug's well documented ability to reduce the most obvious signs and symptoms of MS such as relapses and lesions appearing on MRIs, Tysabri also has a positive impact on some less apparent but very debilitating aspects of MS, such as depression and fatigue (click here). Those of us who suffer from MS fatigue know all too well how crushing a symptom this can be, and in fact for some patients MS fatigue is their most debilitating symptom. Many patients don't realize it, but in addition to the depressing nature of the destructiveness of MS, the disease can cause physical changes in the brain that can trigger depression. So, the fact that Tysabri can improve fatigue and depression in MS patients is no small positive.

Some troubling news about the oral MS drug Gilenya: it was disclosed earlier this month that a patient who had been on the drug for four years developed PML (click here). This is the second case of PML reported in patients taking Gilenya. Like Tysabri, Gilenya is a powerful immunosuppressant, and though its mechanism differs from that of Tysabri, both drugs are effective in treating RRMS in large part by keeping T cells out of the central nervous system. While the incidence of PML in Gilenya patients appears to be quite rare – there are currently about 110,000 patients taking Gilenya – this latest case serves to illustrate the potential dangers of long-term immunosuppression. As previously noted, these newer, more powerful MS drugs have dramatically increased the quality of life for many relapsing remitting patients, however, the potential dangers associated with their long-term use remained largely unknown. Keep in mind, most drug trials last only 2-3 years, and until newer, more effective, and perhaps more benign treatments become available, patients are expected to be on these drugs indefinitely.

In more bad news regarding Gilenya, the much anticipated results of a trial testing the oral MS drug on patients with Primary Progressive Multiple Sclerosis (PPMS) were finally released, and much to the chagrin of those of us who suffer from this especially insidious form of creeping paralysis, the news wasn’t good (click here). Gilenya proved to be no better than placebo in treating primary progressive disease. This was a very disappointing outcome as there are currently no approved therapies for treating PPMS, which afflicts approximately 10% of the MS population. PPMS differs from RRMS in that PPMS patients never experience any relapses or remissions, instead only a steady increase in their ever more disabling symptoms. There are quite a few other differences between these disease types, including the fact that PPMS attacks men and women in equal numbers, while the female to male ratio in RRMS is somewhere along the lines of 3 to 1. Take it from me, PPMS is a grizzly bear, and this was the first drug trial involving PPMS patients in quite a long time. Researchers were initially very optimistic about this trial’s chances at success, but their expectations proved to be misguided, dammit. There are more trials directed at progressive disease now underway, and researchers are increasingly focusing their attentions on the enormous problem of progressive MS, so hopefully there will be better days ahead.

Those patients taking Tecfidera or thinking of starting Tecfidera treatment will be interested in a recently released study that looked at the levels of immunosuppression brought about by the drug (click here). Tecfidera is one of the newest “blockbuster” MS drugs to hit the market, an oral drug that is supposed to have a less daunting side effect profile than some of the other powerful MS disease modifying drugs now available. Although not initially marketed as such, it turns out that Tecfidera is a potent immunosuppressant, and patients on it are well advised to get regular blood tests to make sure their white blood cell counts don’t drop into dangerous territory. This new study sought to understand exactly which immune cells are most affected by the drug, and found that a type of immune cell known by the catchy name CD8(+) T cells are more heavily suppressed by Tecfidera than other lymphocytes (a type of white blood cell). This is significant because CD8(+) cells are heavily involved in fending off viruses, and if they are overly suppressed a patient could be made vulnerable to opportunistic viral infections, such as the infamous JC virus, which can cause PML. No reason to panic if you are on Tecfidera, but definitely reason to insist that your neurologist is diligent in checking your blood counts.

♦ Okay, I’m not going to giggle, I am not going to giggle… Researchers have recently identified a new symptom of neurologic disease related to Restless Leg Syndrome (RLS), a condition dubbed Restless Genital Syndrome or RGS (click here). Also known as Persistent Genital Arousal Syndrome, the condition was recently described in a 65-year-old female patient suffering from Parkinson’s disease. I know that many MSers, myself included, complain of restless leg syndrome. RLS can drive you absolutely batty, making your limbs feel like they have been overwhelmed by the creepy crawlies, urgently insisting that they need to move for no apparent reason whatsoever. I call my version of the syndrome “Restless Everything Syndrome”, as it effects not only my legs but my arms and hands as well. It never even occurred to me that The Mean Wrigglies – my other name for the condition – might cast it's maddening spell on someone's naughty bits. And now I find out about Restless Genital Syndrome. Gadzooks!

Thinking back, it occurs to me that RGS may have been my first ever neurologic symptom, manifesting itself quite suddenly when I was around the age of 12. Yes, I can vividly remember my nether regions becoming plagued by an ever growing restlessness at the start of my adolescence; by the time I was in high school my trouser worm was positively hyperactive, a coiled spring just looking for any chance to go “boing”! Damned impatient precocious baloney pony! And then, as a young adult, my Mr. Winky developed a veritable wiener wanderlust, an almost whimsical need for tallywhacker exploration and ding-a-ling derring-do! Such was my tragic lot, to be tormented in the very bloom of youth by as pernicious a condition as Restless Genital Syndrome! RGS, epidemic amongst teenagers worldwide!

I’m terribly sorry for the above display of rank immaturity, as I can only imagine that RGS is an extremely distressing condition for any individual having to deal with it. My sincerest apologies. My only excuse is that I'm as mature as two-day-old scotch. To make up for my boorish behavior, here’s a gift of music, a rockin’ old stomp blues number about a lady who most definitely did not suffer from RGS, by the little-known but in his day absolutely irrepressible Mr. Wynonie Harris…

♦ Researchers have recently determined that Constance Wilde, the wife of legendary 19th century Irish writer, wit, and bon vivant Oscar Wilde, died of multiple sclerosis (click here). It seems that Constance Wilde suffered from a mysterious malady that none of the doctors of her time could diagnose. She first became ill in 1889, suffering from lameness in her leg that required her to use a walking stick. Over the next several years her disease progressed, and she suffered from bouts of severe pain as well as decreasing mobility. In 1896 she wrote, “I am tired of doctors and no doctors finding out what to do with me”. Sound familiar? In 1898 she underwent surgery, performed by a doctor who was convinced her bladder problems were caused by a tumor, and she died several days later. So, it seems Constance Wilde received medical care in 1896 that is just about on par with that received by a few of the MS patients I know in 2015. Sadly, I'm only being mildly sarcastic here, and I’m sure Oscar would have something quite droll to say about the current state of MS affairs… In honor of Constance Wilde, here are some of her famously sardonic husband's amusing quips:

– "The world is a stage, but the play is badly cast."

– "I like men who have a future and women who have a past."

– "Work is the curse of the drinking classes."

– "Anyone who lives within their means suffers from a lack of imagination.”

♦ A Wheelchair Kamikaze reader recently reached out to me with what I think is a terrific idea. An MS sufferer herself, she wants to start a website on which artists with MS can sell their work, with a percentage of the proceeds going to MS nonprofits. Seems like a terrific concept as I’d love to find a no hassle place to sell my photos, and I know quite a few other MSers with an artistic bent who I’m sure would take advantage of such an outlet if it existed. I you're interested, please take a few minutes to fill out an online survey about the planned website (click here), which will help the website creator as she moves forward with her idea.

♦ Regular readers of this blog probably know that my favorite theory regarding the root cause of MS has to do with ancient viruses called HERVs (Human Endogenous Retroviruses) that have, over the course of millions of years of evolution, become incorporated into human DNA. At points in the distant past these viruses were infectious and perhaps deadly, but through the eons they've been rendered inert. Scientists thought that these bits of ancient viruses were permanently dormant, but over the last decade evidence has emerged suggesting that they can be activated by the presence of other viruses, bacteria, and/or toxins (the primary suspect is Epstein-Barr virus), and once activated can cause our own cells to produce proteins that identify the cells as potential attackers. This would set the immune system into motion, and thus we might have the mechanics behind “autoimmunity”. This is the only rational explanation for autoimmunity I’ve yet come across, and my gut tells me that investigations into these ancient viruses will upend modern medicine. Some researchers now believe that HERVs may be the driving force not only autoimmune diseases, but also many cancers and even some psychiatric illnesses. Let’s not forget, despite the fact that all current MS drugs target the immune system, the aberrant immune response in MS is more a symptom than a cause, a sign that there is some deeper as yet unidentified problem behind all the chaos.

A new study provides yet one more hint that HERVs play a significant role in multiple sclerosis. Scientists decided to see if antibodies to a specific HERV that has been associated with MS were more prevalent in MSers than in healthy people (click here). Sure enough, two of the antibodies that target this ancient virus were found to be elevated in MS patients when compared to healthy controls, indicating that the virus was active in those suffering from MS. Furthermore, antibody levels decreased after treatment with interferon beta (the stuff in Rebif, Avonex, Betaseron, and Plegridy). Might it be that these drugs suppress MS disease activity because of their antiviral properties rather than the supposed immunomodulatory properties that the MS establishment has been touting for the last 20 years? Things that make you go “hmmmmm…”

♦ Two new studies indicate that drinking lots of coffee can protect people from getting multiple sclerosis (click here). A study out of Sweden – yes, those Swedes have been up to a lot of MS research lately – found that people drinking six or more cups of coffee a day were one and a half times less likely to develop MS than people drinking less coffee. Disappointingly, no word on whether the consumption of Swedish meatballs has any impact on the disease. A US study looked at similar data and found that folks who drank four or more cups of coffee were also one and a half times less likely to develop multiple sclerosis. No word on whether coffee consumption impacts people who already have MS. I spoke to my naturopathic doctor about these studies and although many people might jump to the conclusion that caffeine is probably the reason behind coffee's anti-MS properties, she reminded me that Java contains a wide range of biologically active components, so caffeine alone may not be the answer. I’ve always been a tea drinker, so it's no wonder I got this damned disease. I must say, though, that if I drank 6 cups of coffee a day I'd be so wired that not even the quickest researcher would be able to catch and hold me long enough to conduct any kind of medical study on me. That’s a hell of a lot of coffee. Also, if I tried to drink 6 cups of coffee a day with my current MS related bladder issues, I would simply never stop peeing. Literally. Never. Never ever, not for a single second stop peeing. My wheelchair would have to be converted into a commode.

In tribute to the researchers who conducted these studies, who, considering the current pay to play model of medical research were probably employed by Starbuck's, I present you with the following delightful old tune, “Java Jive”, performed by the classic swing era vocal group The Ink Spots…

♦ In more news about potential natural remedies, researchers in Chicago have discovered that the oral ingestion of cinnamon can suppress multiple sclerosis, at least in mice (click here). Cinnamon appeared to fight off the mouse version of MS in animals that didn’t yet have the disease, and helped suppress symptoms in mice that did. Now, I generally don’t report on MS research done on mice because the most common mouse model of MS, called EAE, bears very little resemblance to the human version of the disease. So many substances have been found to cure mice with EAE that I usually don’t even bother reading research reports once I realize the experiment being reported on was done on mice with EAE. If even a tiny fraction of the substances that cure EAE were effective in treating multiple sclerosis, MS would have been wiped out decades ago. Despite these caveats, cinnamon is pretty yummy, so for those who might want to try gulping down some cinnamon on the off chance it might help their disease I'll go ahead and provide the following instructional video, featuring YouTube sensation Glozell Green:

♦ Here are three bits of MS research news that share one thing in common: the yuck factor. Though they’re all different, upon reading these studies my first response was to wrinkle my nose and say “blechh!”

First up, some news out of Australia about a very promising new drug targeted at secondary progressive multiple sclerosis (SPMS) that uses the bacteria found in human acne as one of its ingredients (click here). Go figure, zit juice might someday help vanquish progressive MS. Yuck! Quite honestly, I don’t think there is anything so revolting that I wouldn’t try it if I thought it might help me fight my disease. What’s that? Crawling up the ass of Chris Christie might slow down my disease progression? Get me to New Jersey!

Our second piece of cringe worthy MS news is quite fascinating, really. Researchers in Australia (Aussies again, what’s up with that? They must be in cahoots with the Swedes) noticed that women who are infected with the bacteria that causes stomach ulcers have a reduced risk of developing MS (click here). Specifically, the study found that 14% of women with MS were infected with the bacteria H. pylori, but the same bacteria showed up in 22% of healthy subjects, a wide enough discrepancy to suggest that infection with the bacteria somehow protects against MS. Researchers propose that H. pylori itself may not inhibit the development of multiple sclerosis, but that infection early in life with certain bacteria and even parasites may prime the immune system to fight infectious agents and steer it away from attacking the body’s own cells. This line of thought is often referred to as the “hygiene hypothesis”, which states that the ultra-hygienic nature of life in the developed world may actually be detrimental to long-term health. After all, our immune systems evolved in the presence of all kinds of infections and parasites that are no longer part of life in hygiene obsessed Western cultures. The absence of such nasties may leave the immune system with too much time on its hands, eventually leading it to mount an attack on the body’s own cells. As they say, idle hands to the devil’s work…

In a related piece of nausea inducing MS news that may argue against the hygiene hypothesis, a study demonstrated that drinking parasitic worm eggs appears to be of no use in battling RRMS (click here). In this trial, patients drank a solution containing worm eggs every two weeks for 12 weeks. Though the treatment was well-tolerated (I take this to mean that nobody hurled while drinking their worm eggs), it also proved to be ineffective. Previous studies of this ilk have found that similar treatments have helped patients with Crohn’s disease, so maybe the jury is still out on worm egg cocktails as a treatment for autoimmune disease, so the hygiene hypothesis lives on. Heck, I’ll take parasites over MS any day of the week. In fact, I’ll have my wormtini dry and with olives, thank you… Here’s mud in your eye! Hey, there’s an idea for a MS clinical trial…

♦ As has become my tradition, I’ll end this edition of Bits and Pieces with some red-hot music by an artist tearing it up in the “neo-soul/R&B” genre. Though Nick Waterhouse hardly looks the part of the soul shaking bluester, his music has turned this funky monkey into a Nick Waterhouse junkie. In this video Nick and his band are joined by Daryl Hall and some additional sensational musicians. The saxophone on this track slays me. If this doesn’t shake your booty it's time to shout "code blue" and break out the defibrillators…

RIP George Bokos, two years gone but never forgotten.

Monday, March 9, 2015

National MS Society Decision Makers Take Big Bucks from Big Pharma

As I detailed in two recent Wheelchair Kamikaze essays, the American National Multiple Sclerosis Society has repeatedly rejected grant proposals to help fund the only FDA approved human MS stem cell trial currently being conducted in the US, which is now underway at the Tisch Multiple Sclerosis Research Center of New York (click here and here). These two previous posts resulted in a flood of email and phone calls to the powers that be at the NMSS (thank you, dear readers), who responded by saying that the Society makes decisions regarding which research projects to fund based on the recommendations of committees populated by a wide range of internationally renowned experts. This got me thinking, just who are these experts and what elements might go into their decision-making process? Inspired by a comment left by WK reader Jennifer Ziegler, I decided to do some digging.

One of the provisions of the ever controversial Affordable Care Act (otherwise known as Obamacare) is the creation of a website that allows the general public to search a database of pharmaceutical company payments to physicians, called the Open Payments Data website (click here). For those who may be blissfully unaware – and as outrageous as it may seem to those who are aware – it’s common practice in this country for pharmaceutical companies to line the pockets of the physicians who prescribe their products by way of cash payments given out largely as consulting and speaking fees. Mind you, for the most part these payments are perfectly legal, but it does make one wonder just how objective even the most well-meaning physician can be when making decisions that involve choosing between the products of the drug manufacturers whose money they accept versus those of their benefactor's competitors. This ethical quagmire is often described quite politely as a potential “conflict of interest”.

The NMSS helpfully provides lists of the “Scientific Peer Reviewers” who advise the Society on decisions regarding which research projects are worthy of support (click here). Plugging the names of these peer reviewers into the Open Payments Data website reveals what I think is some enlightening information. First, though, please let me illustrate just how much money the pharmaceutical companies that sell MS drugs pay to physicians in efforts to promote their wares. On a drug by drug basis, the following list details the amount of money that made its way from pharmaceutical company coffers into the pockets of MS doctors in the five months spanning August-December 2013. Naturally, the list excludes drugs that have been approved since 2013. I gleaned this info from the Pro Publica website (click here), which provides detailed numbers derived from the database compiled by Open Payments Data:

· Aubagio $3.4M

· Avonex $775.8K

· Betaseron $510.8K

· Copaxone $4M

· Gilenya $682.2K

· Rebif $856.6K

· Tecfidera $2.2M

· Tysabri $1.4M

· TOTAL $13,825,400

Your eyes are not deceiving you, the pharmaceutical companies paid MS doctors who prescribe their drugs $13,825,400 during the last five months of 2013 alone. Again, this is all publicly disclosed data, and such payments are perfectly legal. Call me crazy, but I can think of only one non-expletive that can adequately describe that number: Yikes!

Now, moving on to the NMSS and its peer reviewers; the National Multiple Sclerosis Society utilizes nine standing committees to review research grant proposals for MS research. As previously noted these committees are comprised not only of physicians, but also PhD researchers as well as lay experts in various related fields. It should be noted that the Open Payments Data website contains only information on pharmaceutical payments to licensed physicians, so while the PhD researchers who sit on these committees might occasionally benefit from pharmaceutical company largesse, such payments wouldn’t show up in the database. It should also be emphasized that the physicians on the following list are not evil people; far from it, they are simply professionals legally taking part in an insanely dysfunctional medical system. I'm sure that those who actively treat patients care deeply about those patients. I’ve even had the occasion to meet one or two of these doctors, who I would without hesitation describe as quite brilliant. Still, the pernicious influence of pharmaceutical company money can’t be discounted, even if it works only on a subconscious level.

The two committees I chose to investigate are those that include licensed MDs and which seemed most likely to play a role in making decisions on human stem cell trials. Here then, a list of MD peer reviewers who sit on NMSS advisory committees who accepted pharmaceutical payments from August through December 2013, and the amount of money they received. These totals exclude any funds paid for medical research efforts:

MDs On The NMSS "Research Programs Advisory Committee" Who Received Pharma Money

· Dr. Bruce Cohen, Northwestern University Medical School – $224.87

· Dr. Anne Cross, Washington University – $4311.28

· Dr. Stephen Hauser, UCSF – $4184.86

· Dr. Mary Hughes, Neuroscience Associates – $13.62

· Dr. Aaron Miller, Mount Sinai School of Medicine – $26,855.11

· Dr. Michael Racke, Ohio State University Medical Center – $5733.86

MDs on the NMSS "Clinical and Translational Research Committee" Who Received Pharma Money

· Dr. Laura Balcer, University of Pennsylvania – $2281.36

· Dr. Bruce Cree, UCSF – $74,965.41

· Dr. Philip Dejager, Brigham and Woman's Hospital – $15,294.97

· Dr. Edward Fox, MS Clinic of Central Texas – $76,760.44

· Dr. Omar Khan, Wayne State University – $112,964.52

· Dr. Andrew Pachner, UMDNH-New Jersey Medical School – $29,995.44

Yes, in the mere five months covered by the records of the Open Payments database one of the NMSS research committee physicians received over $112,000 from pharmaceutical companies, two received over $74,000 each, and two more received over $25,000 each. When considering these numbers, ask yourself whether you would trust the recommendations of a film critic who was found to be receiving generous payments from some of the movie studios which produced the films he was reviewing? Would you allow that critic to decide which scripts should be greenlighted and made into movies if you knew that some of those scripts might in some way damage the profit-making abilities of the studios from which he was receiving payments? Me neither.

I’ve often railed that the NMSS should immediately stop accepting funding in any form from the pharmaceutical companies, if only to avoid even the slightest hint that those funds might influence the Society’s actions. I’m confident the goodwill generated by the Society taking such a public stand would far outweigh any financial hit they might incur, and in fact would be priceless. After looking into the pharmaceutical monies received by physicians who serve with the NMSS in research decision-making capacities, I find myself aghast at my discoveries. Even if the doctors involved are nothing but well-intentioned, as I’m sure they are, I would think it impossible that the tens or even hundreds of thousands of dollars they receive from pharmaceutical companies would have no influence on their decision-making process, perhaps even only on a subconscious level. If these payments didn’t result in tangible benefits for the pharmaceutical companies making them, they wouldn’t be made. Large corporations are not in the habit of handing out millions of dollars a year for no good reason. This may be good business, but it makes for bad medicine.

I urge the NMSS to immediately institute a policy forbidding physicians who sit on any of their decision-making committees from accepting pharmaceutical monies for any reason. The confluence of the interests of for-profit corporations with the clinical practice of medicine and medical research cannot be anything but corrosive. These practices will only stop when we as patients and those who love us rise up and demand action. It’s horrendous enough to be stricken with a dreadfully heinous disease intent on robbing those it attacks of their very humanity; to find oneself simultaneously caught in the misguided, tangled mess that is the modern medical industrial complex can crush the soul. It’s time for those of us stricken with MS to make our voices heard, to make a stand and demand that the largest MS advocacy organization in the world take the initially painful but ultimately crucial steps towards living up to their mandate; to not preserve the status quo but instead eradicate once and for all the fetid scourge of multiple sclerosis, a mission I fear impossible when done in concert with corporate entities whose own legal mandate is to turn illness into industry.

The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here). I would ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, making pains to avoid personal attacks. The goal is not to antagonize, but to foment change that would benefit both the National Multiple Sclerosis Society and the patients it is meant to serve.

I leave you with the following brilliant piece of video from the HBO TV program Last Week Tonight, featuring John Oliver. This incisive and hilarious segment illustrates better than I ever could just how insane is the current state of Big Pharma/physician relationships. Please, please watch, learn, and enjoy…

Tuesday, February 24, 2015

Interview With A Kamikaze

I was recently contacted and asked for an interview by fellow MSer Meagan Freeman, who writes the excellent blog “Multiple Sclerosis, Motherhood, and Other Traumatic Experiences: The Life of a Nurse Practitioner With MS”. After checking out Meagan’s blog and making sure she wasn’t part of the vast government conspiracy intent on siphoning off my Cosmic MS Mojo for use in covert attempts to transform reptilian aliens into characters on the “Real Housewives” reality TV shows (you didn’t think those people were actual human beings, did you), I readily agreed.

Meagan asked me a series of eight questions, on topics ranging from what I may have learned from dealing with my disease (that La Paz is Bolivia’s third most populous city – oh, wait, on second thought I think I learned that from the CNN show “Anthony Bourdain’s Parts Unknown”) to my opinion of stem cells (I think they're kind of cute, especially the ones with long whiskers).

I’ve taken the liberty of posting three of Meagan’s questions and my corresponding answers below. To read the full interview, you’ll have to hoof it on over to Meagan’s blog, by (clicking here). While you’re there, be sure to check out some of Meagan’s other essays. She’s a passionate, insightful writer who shares her, thoughts, feelings, and experiences dealing with the beast quite eloquently.

Thanks for your indulgence…

What motivates you on your “bad days,” and gives you the strength to carry on?

Sometimes nothing motivates me on bad days, and I accept that it's okay to listen to my body and do as close to nothing as possible if that's the way I'm feeling. I think it's very important for MS patients to realize this; discretion is the better part of valor, and some days it's okay to just allow yourself to be a person with a horrible disease who just flat-out doesn't feel good. Even on those days, though, it's important to do nothing to the best of your ability, if that makes any sense. If you're going to stay in bed and watch SpongeBob SquarePants all day, that's fine, but try to enjoy the heck out of watching SpongeBob SquarePants all day while you do it, rather than just succumbing to the fear and misery that can become part of life with multiple sclerosis, using SpongeBob as a backdrop while you wallow in the muck. It's okay to wallow every now and then, also, but don't get stuck in the muck, whatever you do.

On most days, though, what motivates me is the knowledge that this day is the only "this day" that I'm ever going to have, this minute is the only "this minute" that I'm ever going to have, and this second is the only "this second" that I'm ever going to experience. Time is everybody's most precious possession, and it gets more precious with each passing moment. Unfortunately, you don't get any rebates or refunds for time you spend miserable; there's no cosmic scorekeeper keeping track of the brownie points you might think you're earning while wrapped in self-righteous unhappiness. I think back on all the time I wasted when I was healthy, tied up in knots about things that ultimately turned out to be completely insignificant– and, boy, I went out of my way to find things to be miserable about – and realize just what a fool I was.

Not saying that you can somehow just sit around grinning like a blithering idiot and smile away your problems, but we do shape our own realities through the filter of our minds, and we can control our emotions, not the other way around. Pop culture often leads us to believe that it's our emotions that rule the day. In reality, nothing could be further from the truth, as your emotions are born of you, not you of them…

How has writing and blogging changed your daily life? Do you find writing therapeutic?

Writing the blog is definitely therapeutic, much more so than any of the MS therapies I've tried. I honestly never thought that more than a few dozen people, mostly friends and family, would ever read Wheelchair Kamikaze, and its success continues to astound me. Going back to one of your previous questions, researching items for the blog and answering email from readers is one of those things that motivates me on bad days. So, yeah, the blog has definitely impacted my daily life, in so many positive ways.

When I left work to go on disability, I wondered how I would fill my days. In all honesty, occupying my time turned out to not be that much of a problem; despite being relatively successful I never really liked working, and the freedom of no longer having to work was kind of exhilarating. I know this isn't the case for many people, but who I was and what I did for a living very rarely meshed as I built my career. The success of Wheelchair Kamikaze really makes me wish I had devoted more time to writing when I was younger, which may have led me to a more fulfilling career. Better late than never, though, as they say. I just wish that I had something a lot more pleasant to blog about, and that there weren't so many people who can identify with my subject matter.

Any advice you would have for those who are transitioning to using a wheelchair?

My best advice would be to just go for it. It took me way, way too long to finally get over myself and admit that I needed a wheelchair. By the time I did so, I was practically housebound, and the disease had definitely gotten the upper hand as far as my having any kind of independent social life was concerned. Believe me, there's a big difference between Armchair Kamikaze and Wheelchair Kamikaze. In the months immediately preceding my getting the mechanical monster, my ability to leave the apartment on my own had dwindled to almost nil. The day I got my wheelchair the world was once again open for business, so to speak, and suddenly I was able to fill my days with adventurous urban excursions around New York City.

I vividly remember the day my chair was delivered. After the wheelchair tech left, I sat across from the chair giving it the stink eye, having a hard time accepting the fact that this thing was now basically a part of my broken body. Then the 12-year-old boy that lies just below the surface took note of the fact that the thing has wheels, motors, and the joystick. I dragged myself over to the chair and sat down, and was soon whizzing around my living room, recklessly smashing into and upending coffee tables, sofas, and chairs.

That evening when my wife came home she insisted we go out for a "walk", a notion that had me horrified. Me, in public, in a wheelchair?!? Good heavens, no! With a bit of cajoling, my wife soon won out, and we were out on the streets of Manhattan, me with my backside firmly planted in a rolling electrical beast. I was certain that the attention of every pedestrian in the city would be riveted upon me, but instead nobody seemed to notice. Truth of the matter is, most people are so self-absorbed that they barely give any attention to anything outside of their own heads, and they could care less that some guy in a wheelchair is sharing the sidewalk. Gotta say, the moment I realized this was one of the few times I've ever been grateful that narcissism plays such a large role in human psychology.

To read the rest of the interview, please (click here) to go to Meagan’s blog. Thanks.

Tuesday, February 10, 2015

National MS Society FAIL: UPDATE – The NMSS Responds

First, I’d like to thank all who helped contribute to the online dialogue (some might even call it a brouhaha) spurred by my last post on this blog (click here), which detailed the American National Multiple Sclerosis Society’s repeated refusals to fund the only current ongoing FDA approved stem cell trial being done on MS patients in the nation, at The Tisch Multiple Sclerosis Research Center of New York. Your response has been a personal inspiration to me, and your comments and sharing of the article on social media have definitely been noticed by the powers that be.

Several readers have forwarded me statements they received from the NMSS in regards to phone calls or emails they sent to the Society in response to that Wheelchair Kamikaze post. The body of each example of the Society’s feedback includes identical text, apparently written by the Society’s communications department. Nothing wrong with that, per se, as any large organization needs to fashion a coordinated response to any issue of concern, but I do feel it necessary to make some points about the reply sent out by the NMSS. Here’s the heart of the text sent by the Society to those who inquired about the organization’s repeated lack of funding for the Tisch Center’s ongoing stem cell research efforts:

“Regarding stem cell research, the Society is currently funding 15 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin.  We have supported 70 stem cell studies over the past 10 years.  We have also convened international meetings on the potential of stem cells to drive new, effective MS treatments.

The Society’s research funding decisions are determined with advice from internationally renowned scientific experts who review the more than 500 research proposals received each year.  These volunteers bring a broad range of knowledge in different MS specialties, including stem cell research and clinical trials expertise. They help us determine each proposal’s scientific merit and relevance to MS, assess the originality of the proposed project, and evaluate the experience and scientific track record of the applicants. 

The decision to not fund the Tisch MS Center stem cell clinical trial was based on the advice of a review committee comprised of experts with experience in stem cell research and clinical trials as well as perspective from individuals living with MS.  The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns. We are pleased to receive proposals from Dr. Sadiq and to work with him. In fact, the Society has collaborated with his research team on an innovative pilot project to understand one of the biological pathways in MS. 

There is exciting progress being made through innovative research related to the potential of many types of stem cells for both slowing MS disease activity and for repairing damage to the nervous system. With the urgent need for more effective treatment for MS, especially progressive forms of the disease, we believe that the potential of all types of cell therapies must be explored.  

Additional information about Society funded stem cell studies and stem cells research underway internationally can be found on our website

Although my own professional expertise on any of the matters outlined above is infinitesimally small compared to that of the internationally renowned scientific experts who decide which research efforts the NMSS will fund, I’ll take the liberty of commenting from my position of expertise as a patient being forced to slowly watch himself disappear courtesy a horrendous brain and body eating disease. I've also been a patient at the MS clinic that works hand-in-hand with the Tisch Center since 2004, and being the pain in the ass that I am I’ve become quite familiar to and with many of the doctors and researchers involved.

I’ll start my comments on the statement put out by the NMSS with a short, general critique of the Society : Too Much Pharma!

Now, I know that this criticism may sound simplistic, hyperbolic, and even a bit trite at this point, but the influence of Big Pharma on all aspects of medical research has been terribly corrosive, and not because the pharmaceutical companies are staffed by evil ogres intent on hiding cures from a nettlesome population of sick people. No, I honestly believe that the vast majority of pharmaceutical company employees are good people doing their jobs to the best of their abilities, and therein lies the crux of the problem.

The job of pharmaceutical company executives, who helm what are almost all publicly traded enterprises, is to make as much money as possible to keep their companies’ stock prices on an ever increasing upward trajectory. This creates a confounding conflict of interest; treating chronic diseases in perpetuity with hyper expensive drugs has become a very successful business model; curing them, on the other hand, kills that business model. Combine this dynamic with the fact that we’ve handed almost all of our mid and late stage medical research over to the pharmaceutical companies, and you have a research model that is dysfunctional to its core, and one which leads many to suspect that the pharmaceutical companies would use a variety of tactics to delay or suppress any potential treatments – like, say, stem cells – that might damage their core business model.

The NMSS has consistently stated that less than 5% of their donations come from Pharma. I’m not sure if this figure includes all of the advertising dollars the pharmaceutical companies spend on NMSS publications and events, but even if it does, it’s too much. I am always astounded by the massive amount of advertising contained in the NMSS’s primary publication, the slick quarterly magazine Momentum, which serves as the face of the organization that serves as the face of multiple sclerosis for most of the general population of America. It’s hardly a stretch to say that every other page contains a Madison Avenue type advertisement for one MS drug or another, the total effect of which makes it easy to perceive the NMSS as a mere extension of the pharmaceutical companies.

If indeed Pharma monies make up less than 5% of the Society’s yearly take, my best advice to them would be to divest themselves completely of these monies. The shortfall would in large part, I’m sure, be quickly made up by donations from people who have long held back from giving because of their perception of the NMSS being locked in Big Pharma’s embrace. The Society could continue educating patients about MS disease modifying drugs, and do so without even the slightest hint of being under the sway of the companies who manufacture them.

In contrast, the International Multiple Sclerosis Management Practice (IMSMP), the MS clinic associated with The Tisch Center, doesn’t even allow pharmaceutical company representatives through the front door. The doctors who work there are not allowed to take any pharmaceutical company largess, and the clinic is one of the few medical facilities I’ve ever visited that doesn’t have the name of one pharmaceutical product or another emblazoned on every pen, sticky note, and wall decoration in the place. You’ll find none of these things at the IMSMP, precisely because the physician who runs the facility, Dr. Saud Sadiq, is fiercely independent and refuses to let the influence of Big Pharma, no matter how subtle, cloud the judgments of the staff who works there.

It is true, as the statement put out by the NMSS asserts, that the society has funded research into stem cell therapy in the past, and is currently funding 15 stem cell trials in the US. The problem is, as best I can tell, all of those studies are early-stage studies being conducted in test tubes or on animals, and even if successful the benefits of these trials will not reach MS patients for at least a decade or more.

The study being conducted by the Tisch Center is a human trial, using living, breathing MS patients to test a technologically advanced stem cell therapy which, if successful, could revolutionize the treatment of multiple sclerosis in a relatively few number of years, not decades. The Tisch Center spent over 10 years doing test tube and animal research before getting their FDA approval, so that work has already been successfully completed. Again, this trial is the only FDA approved stem cell study currently being conducted on MS patients. The only other such trial that I know of was completed by the Cleveland Clinic last year.

The NMSS writes that their decision whether to fund a project depends on “each proposal’s scientific merit and relevance to MS”, assessment “of the originality of the proposed project”, and evaluation “of the experience and scientific track record of the applicants”. I spoke to one of my friends who works at the NMSS's headquarters in Denver, but due to confidentiality agreements between the Society and grant applicants they could not divulge whatever issues the NMSS may have had with the research being done by the Tisch Center. I can say that the research proved safe enough and showed enough potential coming out of the laboratory to be only the second MS stem cell trial to win FDA approval, and the Tisch center applied for NMSS grants on three separate occasions, each application addressing the issues the Society had with the last. I'm not sure what "individuals living with MS" the NMSS consulted with, but from where I sit (since I can barely stand) the research is most certainly relevant to MS.

Furthermore, the Tisch trial is using proprietary methods to transform raw stem cells into a type of stem cell specific to the central nervous system, a technique far more sophisticated than any previously used in human stem cell trials, and far more refined than the stem cell treatments being offered, at substantial cost, to patients by most offshore clinics. I’d say that accomplishment should tick the “originality” box on the list of NMSS requirements.

As for the “experience and scientific track record of the applicants”, if I were to list the research published by scientists at The Tisch Center in only the last five years, this post might just break the Internet. Okay, maybe that’s an exaggeration, but you can check out just some of the research being done by the Center on their website (click here).

The Society’s response to inquiries about their repeated rejections of the Tisch Center’s research proposals further states that “The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns.” This is quite true. What is also quite true is that Dr. Sadiq submitted not one, not two, but three proposals to the NMSS, attempting each time to address their concerns, to no avail.

The first proposal was submitted before the trial received FDA approval, and one of the primary stated reasons for the NMSS’s rejection of that proposal was the fact that the trial wasn’t FDA approved. After the trial received FDA approval, another proposal was made, which was again rejected. Undaunted, and in need of funding to continue this vital research, the Tisch Center submitted a third proposal, which the researchers involved believed addressed the concerns expressed by the Society's most recent rejection. The third proposal was again rejected.

I’m not privy to the precise concerns expressed by the Society that were used to back up their rejection of the third and final grant proposal submitted by the Tisch Center. However, I do know that the trial did win an extremely rare FDA approval, is using state-of-the-art technology and techniques, is testing methodology that if successful will expand the boundaries of the science, and is being conducted by world-class researchers at a world-class facility in the heart of the biggest city in the nation.

Any safety concerns that the NMSS's experts may have had should have been alleviated by the FDA approval, and unless those experts included soothsayers and seers I'm not entirely sure how they could determine the odds of success for a trial the likes of which has never before been attempted. I may be admittedly biased, but I find it hard to imagine that the Society’s concerns were so dire that three rounds of proposals couldn’t result in a solution. Especially since, even as you read this, hundreds if not thousands of MS patients are flocking to medical tourism sites offering unproven stem cell treatments at facilities of widely varying quality at a cost of many tens of thousands of dollars out-of-pocket.

The NMSS further states that it is funding one pilot project currently underway at the Tisch Center, and this is true. The trial in question was funded back in 2011 to the tune of $44,000, which may seem like a substantial amount of money to the average Joe, but in the world of medical research is fairly negligible (keep in mind that the NMSS receives approximately $100 million worth of donations every year). I spoke with the head of fundraising at the Tisch Center, who told me that the NMSS may have funded another Tisch Center study back in 2005, but she’d have to dig through her files to confirm that. I told her not to bother.

So, there you have it, the National Multiple Sclerosis Society’s response to inquiries as to why they refused to fund a trial that, in my humble opinion, has at least as much potential to change the lives of MS patients as any currently ongoing study, and my reaction to that response. Perhaps I’m partial since I am a patient of Dr. Sadiq’s, but my passion on the subject comes more from the desperation I feel as a human being whose body is being consumed by a relentlessly vicious disease, and not from my allegiance to any medical professional or facility. I promise.

I would urge those who feel similar passion to have their voices heard. The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here).

I would also ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, as to a person the NMSS staffers I know personally are truly good people who are fully dedicated to the cause. It’s just the institution they work for that may be misguided…