Friday, January 23, 2015

A Stem Cell Scam Unravels…

As many MS patients are aware, stem cells represent one of the great hopes for vanquishing multiple sclerosis by way of their tantalizing potential for repairing damaged brain and spinal cord tissues, regulating aberrant immune responses, and ultimately restoring patients to good health. Research into the use of stem cells to treat a wide variety of diseases is increasing seemingly by the day, and scientists are beginning to unlock the tremendous promise of these emerging therapies. The therapeutic use of stem cells may dramatically transform the medical landscape in the coming years, and this prospect provides much-needed hope to patients desperately searching for answers.

Sadly, where there are significant populations of desperate people, there are almost always human sharks ready, willing, and able to take advantage of them. Thus, it seems, we have the story of Regenetek, a Canadian company that arranged for patients to travel to India for an experimental stem cell treatment under the guise of a certified medical clinical trial. Over the last several weeks, the Canadian press has revealed that the man behind Regenetek, Mr. Doug Broeska, allegedly misrepresented his credentials, the qualifications and abilities of his company to conduct a valid medical clinical study, and cajoled, bullied, and berated patients who dared question his authority or the veracity of his claims (click here). It must be said that while some of the patients who underwent the Regenetek’s stem cell therapy in India received no benefit, others have reported good results, and that’s where this story gets tricky. Though Regenetek and Doug Broeska may turn out to be complete shams, the stem cell therapy the company was hawking may have value, at least according to patients who claim to have seen benefit from it (click here).

I first became aware of Regenetek when Mr. Broeska invited me via email to join Regenetek’s private Facebook group, where patients discussed various aspects of the company’s stem cell treatment and their experiences with it. At that time, Broeska was known as Dr. Doug Broeska, or “Dr. Doug”, claiming that he was a “PhD medical researcher”. That rather generic designation set off a few red flags in my mind, especially after a quick Google search revealed little other than the fact that Mr. Broeska had been involved in some sort of electronic medical records company before taking an apparently rather sudden interest in stem cells.

Further red flags sprung up when, after spending a little time on his Facebook page, I saw that Broeska was posting articles he had written on various stem cell related subjects that contained errors and misinformation. These articles were also posted on Regenetek’s website and blog. One article in particular raised my cackles, a piece about HSCT – a type of stem cell therapy in which a patient’s immune system is ablated using chemotherapy drugs and then rebooted through the use of bone marrow derived stem cells, which clinical trials are proving to be quite effective in properly selected patients – that was so ill-conceived that I felt compelled to call out the myriad inaccuracies in the piece. After a bit of back-and-forth, Broeska removed the article, but his seeming intentional misrepresentations of fact set off alarm bells of doubt in me about his credibility.

As I’ve mentioned in the past, I’m not a huge fan of Facebook, and after the above incident I didn’t spend much time visiting the Regenetek page. I was left with questions about the clinical trial the company was supposedly conducting, since it seemed that the only follow-up being done after patients returned from India were e-mailed anecdotal patient self-reports of how they were doing post treatment (no MRIs, neurologic testing, or other objective measures required), as well as doubts about many of the statements and claims made by “Dr. Doug”, but I’d seen how anybody raising such concerns on the site were met with hostility and frankly wanted no part of it. I remained in email contact with one of the members of the group, who occasionally asked for my opinion on stem cell related topics and told me about several disgruntled patients, but other than that I didn’t give Regenetek or Mr. Broeska much thought at all.

A few weeks ago I was alerted to the fact that the Regenetek Facebook site and related webpages had been taken down, along with Doug Broeska’s business profiles on the LinkedIn website. Soon after, an article appeared in the Winnipeg Free Press detailing Mr. Broeska’s alleged web of deceit (click here). Among the article’s findings were that “Dr. Doug’s” claims of earning a PhD at the University of Manitoba could not be confirmed (the University had no record of his graduating), and that another of his claimed degrees came from an institution called Brightland University, which apparently doesn’t actually exist, and is only part of the University Degree Program, an online degree mill that operates dozens of sham institutions. Furthermore, Broeska had claimed that he was a member of the International Cellular Medicine Society (click here), an international stem cell research oversight organization, but the executive director of the ICMS could find no evidence of Broeska’s membership. It had also been claimed that Regenetek’s clinical trial was being run under the direction of several Institutional Review Boards (IRB’s), which are governing bodies that ensure the validity of medical research efforts. No record of any legitimate IRB approvals could be found, and one of the organizations cited by Broeska as overseeing the Regenetek clinical trial was found to be headed up by one of his business partners.

Additionally, Broeska often boasted that Regenetek was a not-for-profit corporation, and that the company actually helped subsidize the cost of patients' treatments, for which the patients themselves paid up to $45,000 US. While Regenetek is indeed registered with Canada as a not-for-profit entity, most of the patients sent for stem cell treatment in India paid their fees to another Broeska owned company, CliniCard, which is a for-profit corporation (click here). Allegations have also been made that Regenetek paid patients that had gone through their stem cell protocol to recruit other patients, and to post testimonials and videos on Facebook and YouTube.

Perhaps worse than all of Broeska’s alleged falsehoods and financial sleight-of-hand were his practices involving many of the patients with whom he dealt (click here and here). According to reports, patients were threatened with being kicked out of the Regenetek clinical trial if they questioned any of the claims or methodologies used by Broeska after they returned from India. Broeska repeatedly stated that virtually all patients undergoing the treatment protocol in India saw “curative effects”, and that many had “returned to complete health without symptoms” (click here). Patients who reported little or no benefit from the treatment were accused of working for competitors, or otherwise having ulterior motives, and were booted out of the Regenetek study. Upon returning home, most patients received little if any follow-up, despite their supposedly enrollment in an ongoing clinical trial. Broeska was known to spend hours emailing and even Skypeing with prospective clients, befriending them in an effort to convince them of the validity of his claims and of his expertise in stem cell research, and ultimately to sign them up for treatment in India, to the tune of tens of thousands of dollars.

Regenetek partnered with an Indian firm called Genesis, whose Chief Operating Officer is an IT professional named Surjo Banerjee, that oversaw the medical procedures performed at a hospital in Pune, India. As previously stated, patients were charged up to $45,000 US for treatment (not including travel expenses), which consisted of CCSVI angioplasty combined with an infusion of stem cells derived from the patient’s bone marrow, in addition to intravenous and intrathecal (spinal) infusions of these same autologous mesenchymal stem cells. While in India, patients also underwent roughly 2 hours of physical therapy each day, purportedly to help the stem cells circulate to where they were needed. Perhaps not coincidentally, studies have shown that periods of intense physical therapy alone can markedly improved the functionality of many MS patienes, although the benefits fade after physical therapy is stopped (click here). Many of the claims and methodology used in what Regenetek dubbed the CTP (Combination Treatment Protocol) have been challenged by doctors familiar with stem cell technology (click here).

Due to the fact that so little actual follow-up was done on the approximately 70 patients who traveled to India for treatment, it’s impossible to quantify the actual effects of the treatment; suffice it to say that of the relatively few patients who have been heard from there are some who say they have seen sometimes dramatic improvement, and others who claim the CTP treatment to be a total failure. It’s impossible to objectively judge the veracity of subjective anecdotal patient reports, as any number of factors could contribute to the self-reported success or failure of any experimental medical procedure.

I will say by all accounts it does appear that Regenetek patients did receive some sort of stem cell therapy from licensed doctors while in India, effective or not; the scam that occurred lies mostly in the manner by which patients were recruited and then handled after they returned home, and in the financial shenanigans allegedly undertaken by Mr. Broeska and his colleagues. Unfortunately, because of the lack of any rigorous follow-up whatsoever, the actual effects of the treatment on the 70 or so patients who underwent the stem cell therapy will never be known, at least in any scientifically valid fashion. This is a real shame, for who knows what valuable lessons might have been learned if these patients had been properly assessed post treatment by qualified medical professionals?

As of this writing, the Indian company Genesis, which worked hand-in-hand with Regenetek until news of this scandal broke, is planning to continue offering stem cell treatments in India (at a cost of $16,050 US, as compared to the $45,000 charged by Regenetek), and even has plans to open a clinic in Trinidad despite the questions surrounding its offerings (click here). Patients who paid deposits to Regenetek but have not yet gone to India are demanding refunds, but thus far have had very little success getting any response. Posts have appeared on Facebook pages on which this matter has been discussed stating that representatives from Genesis or Regenetek will not be answering any inquiries posed on those sites. A Canadian doctor who worked closely with Regenetek has claimed she was “scammed” (click here). It seems that most of the players involved are now in serious “cover your ass” mode, and investigations into Regenetek by the Royal Canadian Mounted Police and other Canadian government agencies are now underway.

If any or all of the allegations made about Regenetek hold true, I hope all who read this will see this story as a cautionary tale about the dangers lurking in some corners of the world of alternative medicine. Distressingly, there are living, breathing human beings out there who somehow feel no guilt in taking advantage of desperate people with horrible illnesses. Back in high school I took an art appreciation class, most of whose content I don’t remember. I do remember, though, something that my art teacher, Mr. Rosen, once said: “Be careful, there’s human garbage out there…” Don't ask me what that quote had to do with art appreciation, but it sure was memorable, and quite apropos of charlatans who seek to profit from the desperation of sick people.

Friday, January 9, 2015

A Call to the Cosmic Complaint Department…


Mr. Universe…?

Mrs. Universe…?




Well, if you’re listening, I think there’s been a terrible mistake. You see, I’ve got this, well, this creeping paralysis, and it just won’t stop creeping… and creeping… and creeping. It’s creeping so much that it’s creeping me out, and I’m afraid it’s about to swallow me. So, before things get completely out of hand, I’d like to lodge a formal complaint and see if I can get some kind of a cosmic credit, or even maybe a do-over. You know, like back in the schoolyard, when in the middle of a game something would go wrong and all the kids would agree to just wipe the slate clean, and make believe that whatever happened never happened. Do you think we could work something out along those lines? A do-over? Just one?

The department store Nordstrom is famous for taking back almost any item, even if it’s been used, and I’m thinking I must be due some kind of refund or other form of galactic recompense. I mean, if Nordstrom can do it, certainly you, a universe filled with multiple dimensions and all kinds of crazy quarks and pulsars and quasars, must have some way of correcting what has obviously been a royal screwup. No, I don’t have a receipt, but I do have a birth certificate and an expired driver’s license, will that do?

Because, really, I’m pretty sure this isn’t the way things were meant to play out. I’m fairly certain that somewhere along the line the story of my life has gone way off script, like in one of those old movies where somebody accidentally picks up the wrong suitcase at an airport or train station and their fates get switched with the person who picked up their suitcase, and all sorts of wackiness then ensues. I’m positive that somehow my cosmic suitcase got switched, and I’m not at all happy with the ensuing wackiness.

When I was younger, I had a preview reel of what my life would be like running through my head, and I’m certain that literally feeling sick and tired all of the time while becoming ever increasingly paralyzed wasn’t in any of the selected scenes playing on an endless loop in my noggin. I was going to be a famous writer, rock star, or movie director, and my life was supposed to be filled with all kinds of exciting escapades and adventures, with just enough drama thrown in to make things interesting. I wasn't expecting a fairytale, but the screen in my head wasn’t showing a disaster flick, either.

Yes, yes, I know, all of that might seem ridiculous and downright juvenile, but I never claimed to be the paragon of maturity. After all, you’re only young once but you can be immature forever, right? And yeah, I’m well aware that almost no one’s youthful dreams ever really come true, but I never ever imagined that dreams could so easily turn into nightmares. Looking back I’ll admit that I didn’t always make the best choices, and probably made more than my share of mistakes, but surely I never did anything bad enough to deserve this, did I?

I mean, I just watched a television interview with the serial killer Son of Sam, who slaughtered six people and terrorized New York City for months on end back when I was a teenager, and he looked healthy as a horse sitting there in prison. Doesn’t he deserve a nice dose of creeping paralysis? Or how about the monsters who rape or hurt children, or plot horrific terrorist attacks that kill dozens or hundreds of people? I see them on the news all the time, looking all hale and hearty. How about a liberal sprinkling of progressive multiple sclerosis for them?

Believe me, you don’t have to tell me that I’m no saint, but even with all of my missteps and blunders and mistakes, the person I hurt worst of all most often seems to have been myself. Being sick has given me all kinds of time to look back and analyze my past, and at this point I think my regrets have regrets. I’d love to be able to use some of the insights all of this introspection has given me to live a more worthy life and forge a future free of the dunderheaded moves of my past, but the way things are heading if I think too much about my future I might just poop in my pants. As a matter of fact, without being granted a cosmic refund or credit or do-over, pooping in my pants could very well be a large part of my future. Gross. And things could very well only go downhill from there.

I’ll admit that getting sick hasn’t been all bad, and in some ways it’s given me freedoms that I probably otherwise never would have realized. I was able to stop working and start writing, which is probably what I should have been doing all along. Before this creeping paralysis crept so far I was able to take lots of photos and videos from my wheelchair, fulfilling creative impulses I’d long dreamt of indulging (without the wheelchair part), but I’m afraid those days are probably over. I sure have learned a heckuva lot and met all kinds of interesting people, many of them fellow patients, most of whom, FYI, also don’t deserve the crap they’ve been slapped with. It would be nice, Mr. or Mrs. Cosmos, if you could find a way to cut them more than a little slack, too. I’ve discovered emotional and physical resources within myself that I didn’t know existed, which has been kind of cool. But now things are getting pretty dicey, and I think I’ve squeezed all the positives out of this experience that there are to be squeezed. In all honesty, I’m getting scared. Really, really scared.

So what do you say? Can you give a brother a break? How about this: forget about making me better, just stop me from getting any worse, okay? Certainly not the ideal situation from my perspective, but I’ll take it. How’s that for a compromise? See, I’m reasonable, not like all those asshats in Washington. Can’t we work something out? A little give-and-take? I’m not sure I have all that much left to give, but I’m open to suggestions. I’ll be right here waiting for your answer, just a pimple on a flea’s ass in this ever-expanding universe, but I trust that you’ll know where to find me.



Wednesday, December 24, 2014

Ho Ho Heave

Well, it seems that I got a bit of an early Christmas present this year – in the form of THE FLU! Not a present I asked for, wanted, or needed. I guess I opened the window and in flew Enza…

Suffice it to say that the flu and MS don't play well together.  As a result of their unholy alliance, I'm forced to compose this blog post from bed, using my iPad and a blogging app. The iPad is a wonderful little device, but it's voice recognition capabilities suck, at least for composing anything longer than just a few sentences. So, I'm going to have to keep this short, if only to keep from getting so frustrated that I throw the thing across the room, and I don't think Santa has a new iPad for me loaded up and ready to go on his sleigh. I am hoping that he leaves a new central nervous system for me under the tree, and if he doesn't I'm prepared to bring a lawsuit.

Just wanted to wish everybody a very Merry Christmas, Happy Hanukkah, Great Kwanzaa, and also a Happy New Year, just in case I don't get the chance to post again before 2015 rolls around. May the holidays bring all of you happiness, joy, and good health. Multiple sclerosis is no gift, but the ability to rise above it, even if only occasionally, most certainly is. Please try to make good use of that gift whenever you can, if only to stick your thumb in the eye of this Grinch of an illness.

The following is probably my favorite Christmas song of all time, released by a band called The Royal Guardsmen in 1969. I had this record when it first came out, when I was six years old, and I played it over and over and over again. I was a super big fan of the Peanuts gang, and Snoopy was my favorite character. The heroic little beagle's struggles against the dreaded Red Baron fired my six-year-old imagination, and this song, celebrating a short and thoroughly unexpected break in their epic battles, sparked a tender emotion in me that still smolders 45 years later.

This is the long version of the song, complete with a rather elaborate intro mimicking a radio broadcast from somewhere on the Western front in the middle of World War I. I hope you enjoy, and as the Red Baron says to Snoopy at the very moment that Snoopy thinks his number is up, "Merry Christmas, My Friend(s)!"…

Friday, December 12, 2014

Winter’s Discontents

(Apologies to The Mamas and The Papas)

All the leaves are brown, and the sky is gray
I needed to go outside, on a winter’s day
Struggled with socks, sweater, coat; but when all was done and said
Barely had the strength, to just get back into bed…

Please excuse the above bad poetry (actually, it’s a gross disservice to poems to even call it poetry), but I just couldn’t resist. Here in New York City, winter is once again upon us, and along with the season’s cold and inclement weather, for us gimps the winter months are chock full of hurdles and obstacles that the able-bodied need give nary a thought. Simply donning get all of the cold weather gear needed to brace oneself against the chill can prove so damned difficult that the mere prospect of getting out of the house can be daunting all by itself.

In theory, at least, I like winter. The monochromatic palette of the winter months appeals to my black and white aesthetics, and I spent enough years living in Fort Lauderdale (yechh) to know that most human beings look better wearing several layers of clothing. Back in my healthy days I was admittedly something of a clothes horse, my closets brimming with cool duds. When I married my wife I owned more pairs of shoes than she did, and Karen isn’t a one pair for all occasions type of gal. My fetish for shoes goes way back, and my mom likes to tell tales of how, even as a toddler, I would torment shoe salesman by making them haul out box after box of footwear until I found a pair that met my precocious exacting standards. Why my mom allowed the little munchkin me such free reign to terrorize shoe store employees will have to remain a story for another day, but suffice it to say that I think she quietly got a kick out of my shenanigans.

But I digress, the subject at hand is the perils of winter for those of us trying to get through life with uncooperative bodies. Whereas I used to take delight in such winter wear as warm socks, comfy sweaters, and fashionable outerwear, these days all of these items have been transformed into potential instruments of torture. The right side of my body is almost completely defunct – weak, spastic, emaciated and largely paralyzed. My left side is still functional, but is weakening, seemingly by the day. Additionally, the more effort I exert the less functional my left side becomes, and with my fatigue levels at an all-time high my energy reserves leave much to be desired. All of this conspires to transform the formerly simple act of getting dressed into a feat of exhausting contortions, the anticipation of which often makes the thought of getting out of the house an extremely unpalatable option, even though being sequestered away inside my apartment for days and days on end is a recipe for mental malfeasance that also needs to be avoided. Quite the conundrum, then, once the temperature plummets.

During the warm weather months getting ready to go outside is a relatively simple affair, although struggling into a pair of elastic waisted shorts, a pullover short-sleeved shirt, and slip on shoes isn’t nearly as easy as it used to be. Still, even in my current dilapidated state it’s just a few minutes’ tussle and then I’m in my chair and out the door, willfully ignoring the fact that yes, my disease is indeed progressing. Once the temperatures drops below, say, 60°F, things get infinitely more complicated, and the very fact of my distressing physical decline from one season to the next cannot be avoided. Things that were merely difficult to do last year have now become almost impossible, and no amount of denial can paper over this reality.

The first bugaboo to be faced when preparing to venture out of doors all by myself is a pair of nefarious garments called “socks”. With a little effort and ingenuity I can usually get my left sock on without much calamity, but getting on my infernal right sock requires the use of a not so handy dandy device called the “Deluxe Flexible Sock and Stocking Aid” (click here). Basically, this contraption consists of a piece of relatively stiff but flexible material with two long straps attached. The flexible material can be rolled into a cone, on whose skinny end a sock can be scrunched up and pulled over (this miraculous feat is accomplished by my wife Karen the night before I’m due to make an appearance out in the world). In theory, then, a person can place the device on the floor and insert their foot into the wide end, and then by tugging on the straps pull the sock onto their foot using the flexible cone thing as a kind of guide. I’m sure this works quite well if the user has at least some dexterity in their right leg and arm. My right leg below the knee, though, has as much dexterity as a piece of overcooked fettuccine, so using this device is increasingly becoming an exercise in futility. The notion that I’ve become too gimpy to use a device made specifically for gimps thrills me to no end, let me tell you. As does the prospect of facing subfreezing temperatures without the benefit of a pair of warm socks. Sigh.

Next up in the cavalcade of whimsy that has become the process of my getting dressed are pants. Luckily, a couple of years ago I discovered that the Duluth Trading Company was selling fully elastic waisted decent looking trousers, which negated my needing to struggle with buttons or clasps to fasten my pants, which even back then had become nearly impossible. For whatever reason the company no longer offers these garments, but I was wise enough to stock up while the getting was good. If anybody knows of similar apparel currently available, please let me know. As long as they aren’t too, you know, ugly. Amazing how resilient vanity is, even in the face of progressing decrepitude, isn’t it?

After struggling with socks and pants, next in line are shirts and sweaters. Even the pullover variety are getting harder and harder to manipulate (the button-down kind may as well be radioactive as far as I’m concerned), and after struggling into them a somewhat disheveled appearance seems just about unavoidable, as a sleeve or shoulder always seems to be bunched up or stretched out in a way I can’t remedy given my limited amount of nimbleness. I suppose I should be happy that I can still don these garments, but there’s that dastardly vanity thing again. If I have to be a gimp I want to be a fashionable gimp, dammit!

Last comes the horror of all horrors, the winter coat. I used to wear all kinds of cool leather winter outerwear, retro car coats and flight jackets, but though these garments still hang in our closet, getting them on and fastened without assistance has become pretty much impossible. My mother-in-law, who is quite handy with a needle and thread, altered a standard military issue peacoat into a Velcro fastened wonder for me, for which I am eternally thankful. When closed up, the thing looks like any other peacoat, as mom fashioned the coat to make it look like the buttons are still fully functional, and folks are always surprised and tickled when I simply rip it open, which I try to do with a dramatic flourish. Still, getting the thing on and off of my stiff, spastic, and weakened body is no picnic, but I suppose we should be appreciative for whatever good graces still lay within our domain. So, yes, I’m quite grateful for my one-of-a-kind Velcro fastened peacoat. As I once said in a previous post, it’s like haute couture for the disabled.

Jeez, it looks like I just composed an entire blog post about the scintillating topic of my getting dressed. How horrifyingly mundane. Thing is, this freaking disease has made even the mundane a challenge, activities that had previously been taken completely for granted now fraught with anxiety, pushing my physical abilities to their limits and conjuring up a maelstrom of disheartening emotion. While the boundaries of those physical limits grow ever tighter as the disease continues its relentless progression I endeavor to live by the motto “use it until you lose it”, but as the losses mount the limitations imposed by these increasing deficits makes using what’s left harder and harder and harder. A decade ago, even on the coldest day of the year, I could be dressed and out of the house in 10 minutes, max. These days, that ever so humdrum of activities called “getting dressed” takes about 45 minutes at best, after which I’m often quite literally so physically spent that I’d rather get undressed and climb back into bed than go about whatever business awaits me out-of-doors. 

But there is life yet to be lived, and with dogged persistence my comrades in arms (weak and spastic arms, but arms nonetheless) and I  forge ahead as best we can, each displaying a quiet steadfastness that should be the fount of much pride, if I do say so myself. I will admit, though, that it’s hard to be prideful when you’re stuck with a sweater half on and half off, the nefarious garment doing its best impression of a straitjacket. Damned disease.

If you’ve made it this far through my long-winded description of getting dressed (egad), you deserve to be rewarded with the following musical delight, a version of The Mamas and The Papas “California Dreaming”, performed by the very underrated classic soul and R&B artist Bobby Womack, who sadly passed away earlier this year. Enjoy…

Sunday, November 23, 2014

iConquerMS – Your Chance to Help Bloody the Beast
Okay, my fellow MSers, are you sick of sitting on the sidelines like powerless spectators observing a do or die contest that will determine your very own fate, waiting anxiously for neurologists, researchers, and pharmaceutical companies to ride to the rescue? Are you, like me, sick and tired of being sick and tired, weary of having very little ability to do anything about the situation except listen to the same old same old, held hostage by a status quo that offers more questions than answers? Do you just for once want to pick up a club and give MS a good smash in the kisser, to kick the fiend squarely where the sun don’t shine, to metaphorically extract a pound of flesh even as the disease quite literally attacks your own? Do you want to actively help conquer MS? Well, take note, that chance has arrived, and you needn’t even get up from your computer to help wage war on our mutual enemy, multiple sclerosis.

Enter iConquerMS, a new patient driven research initiative that allows those living with MS to participate in a groundbreaking research effort aimed at amassing the most comprehensive database about MS patients and the manifestations of their disease ever created. Through the web based iConquerMS portal (click here) patients can participate in a series of surveys and questionnaires that will soon form the most complete repository of information about the disease and those who suffer from it in existence. Researchers from around the globe will be granted access to this data, a wealth of information that could very well reveal brand new insights about the disease itself and those who suffer from it. In addition, the iConquerMS website provides patients and those who care about them the ability to address researchers directly with questions and suggestions, thereby helping to shape the future of MS research.

But first things first -  what exactly is iConquerMS? The face of iConquerMS is a user-friendly website, (click here), designed to allow MSers to easily contribute information about themselves and their disease. The driving idea behind iConquerMS is the concept of Big Data, a pooling of vast amounts of vital information that can reveal patterns and trends that otherwise wouldn’t be detected. Just as the intricate actions of the tides can’t be determined by observing a single drop of water but instead only by studying the oceans themselves, the complexities of multiple sclerosis may very well best be revealed by the pooling of data from tens of thousands of patients. Big Data-enabled MS research may help answer questions such as: what causes the disease and what strategies might prevent it, cure it, or arrest its progression; which treatments work best in which individuals; and what factors affect the progression of the disease.

The initial 18 month funding for iConquerMS has been provided by the Patient Centered Outcomes Research Institute (PCORI), an independent nonprofit organization authorized by Congress in 2010. Tasked with funding research that will provide a chance to overcome the challenges presented by traditional models of medical research, PCORI is working to close the gaps in evidence needed to make the paradigm shifting medical breakthroughs so urgently needed to rid the world of many dread diseases.

One of my favorite MS nonprofits, the Accelerated Cure Project (ACP), is playing a key role in administering iConquerMS. I’ve been involved with the ACP for eight or nine years now, ever since I contributed blood and spinal fluid samples to their MS repository, which was put together to allow researchers access to biologic material provided by a wide spectrum of MS patients. I've been told by anonymous sources that my Wheelchair Kamikaze blood and spinal fluid samples are being kept in a hyper secure facility alongside alien entities recovered from the Roswell flying saucer crash, watched around the clock by a super vigilant squad of ferociously trained Sasquatches. We don’t want that stuff falling into the wrong hands, who knows what bedlam might result?

On a much more serious note, the privacy of patients contributing their data on the website will be even more strictly guarded than my blood and spinal fluid samples and will never be sold to advertisers or otherwise be used for commercial purposes. The IConquerMS project is devoted solely to fostering vital research in the fight against multiple sclerosis, and the iConquerMS website is designed to be highly interactive, promoting contact between people living with MS and researchers studying the disease.

I urge all patients reading this to register at the iConquerMS website (click here) and fully participate in the program, and by doing so take up arms in the battle against our shared enemy. iConquerMS will provide updates on how the data is used and what insights are emerging from the research to all registered users.

Here’s a video that helps explain the iConquerMS project, and how the participation of individual MS patients can help vanquish MS. Knowledge is power, folks, and contributing your info to the knowledge base compiled by iConquerMS may go a long way towards giving multiple sclerosis the good swift kick in the ass it so richly deserves.

Thanks in advance for helping to further the cause…

Monday, November 17, 2014

Bits and Pieces: Multiple Universes Edition (includingLemtrada,theMS-Gut Connection, Progressive MS, Pharma to Doctor Payola,andmore…)

(For those receiving this via email, this post contains videos which can be viewed on the Wheelchair Kamikaze website – click here)

I’ve been reading about the very real possibility of the existence of multiple universes, a collection of hypotheses which state that our universe is actually part of a Multiverse made up of perhaps an infinite number of parallel or alternate universes (click here). As fantastical as this might sound, more and more physicists and cosmologists are coming to accept the notion that our universe is but one of many. In fact, most of the latest cosmological theories and mathematical models of existence point directly to the reality of a physical realm comprised of multitudinous universes, as well as many dimensions beyond the three which our tiny little brains can experience and comprehend.

The form that these multiple universes might take varies from theory to theory, from each universe abiding to its own unique set of physical laws and properties (and therefore some being quite bizarre and very different from our own), to a limitless number of universes similar to this one, with perhaps only subtle changes distinguishing each. The latter model supposes that there may even be an infinite number of like universes each playing out different timelines based on the boundless possible choices each of us makes on a daily basis. In other words, there could very well be universes out there where I don’t have MS, or where I finished that novel I started in 1988, or where my parents never got divorced. Of course, that would also mean that there are universes in which my parents never even met, in which case those universes would have never been graced by my presence. Such a pity.

Given the fact that I have way too much time on my hands and have been able to parse my old healthy life rather obsessively and in minute detail, picking out key instances when a different decision or action on my part might very well have resulted in an entirely different existence, maybe even one devoid of this damnable creeping paralysis, I find the idea of multiple or parallel universes extremely appealing. It gives me great pleasure to imagine a universe in which I am at this very moment driving a sleek convertible sports car way too fast down the Pacific Coast Highway. Or a universe where I would have never spent a minute watching a Tom Cruise movie (sorry, he makes my skin crawl). Or one in which my wife Karen and I just returned home from a long, leisurely walk in the park, strolling arm and arm with effortless grace and ease. How nice to think that all of these scenarios could very well be playing out as I write this, in universes coexisting with our own. Hey, the greatest minds in science say it's possible, and who am I to argue with the greatest minds in science?

Alas, here I am rooted in this universe, in which it’s time for yet another edition of Bits and Pieces, my semi regular compendium of mostly MS related news and items of interest. I hope you find this batch interesting, enjoyable, or at least tolerable, and here’s to the notion that in most other universes there’s no such thing as MS and thus no reason for some alternate version of me to write this blog or for some alternate version of you to read it.

Anyway, on with the show (I apologize in advance for the length of this post, but as I was writing it news broke that the MS drug Lemtrada had been approved by the FDA, which is a pretty big deal, so make yourself comfortable, this may be a long one)…

♦ Reversing a decision it made late last year, the FDA has approved the powerful drug Lemtrada for use in MS patients (click here). Since the drug was initially denied approval in the USA last December it was approved in over 40 other countries, including most nations in the European Union. US patients and neurologists had been agitating for its approval since last year’s FDA denial, as the drug had been shown to be remarkably effective in trials and had been used off label for some years to treat MS patients here in the USA (it was previously known as Campath). One MS neurologist I spoke to soon after the initial denial was quite upset by the FDA’s actions, telling me that the drug had not only rescued one of his patients who had been ravaged by a particularly aggressive case of relapsing remitting MS, but had actually allowed the patient to recover all the way from completely bedridden to back to work.

Lemtrada (chemical name alemtuzumab) is an intravenous drug that works by wiping out a patient’s existing immune system and then allowing it to reconstitute, presumably without the autoimmune tendencies that many believe play a major role in the MS disease process. In some respects, this is the same mechanism as HSCT, the type of stem cell therapy in which a patient’s immune system is ablated using a powerful chemotherapy regimen and then rebooted using the patient’s own bone marrow derived stem cells. It appears that Lemtrada achieves this same goal in less dramatic fashion.

Unlike all other existing MS disease modifying drugs, Lemtrada is not meant to be used indefinitely by the patients to whom it is given. Instead, the drug is administered intravenously for five consecutive days, and then again one year later for three consecutive days. Some patients may require additional infusions at some point down the line, but most do not. Trials have shown that in about 70% of patients with active RRMS the drug eliminates all signs of disease activity (relapses and new lesions) for at least three years after treatment, and in some cases for many years more. In other words, Lemtrada has been shown to put the long-term kibosh on all MS symptoms for the majority of patients with active relapsing remitting disease who have gone through the treatment protocol without further dosing, a result not seen with any other existing MS drug therapy. Some patients have even experienced a reversal of their symptoms, regaining neurological function that had been lost to the disease. As has been the case for all MS drugs so far, Lemtrada unfortunately has no apparent benefit for patients suffering from progressive MS.

These astounding results do not come without risk, however, as a majority of treated patients develop some secondary autoimmune disorders (most often autoimmune thyroid disease, which can typically be controlled with medication), and a small percentage (1%-3%) develop a very serious autoimmune blood disorder, which if caught early can be remedied before any harm is done. As might be imagined, the long term effects on MS patients by a drug this powerful are hard to predict, but the drug has been used to treat patients suffering from various blood cancers for decades. For these reasons, patients treated with Lemtrada must be monitored very closely (most likely in the form of monthly blood tests) for years after their last infusion of the drug.

In the UK, Lemtrada has been approved as a first-line therapy for patients with highly active RRMS. Here in the USA, the FDA has approved Lemtrada only as a third line drug, to be given to patients whose disease has not previously responded to two different MS therapies. This restriction may prove to be problematic, since there are indications that early treatment with the drug provides patients with the best chance for success, in the form of a complete and long-lasting remission of all MS signs and symptoms. For a full discussion of Lemtrada and its associated issues, I urge you read this article recently posted on the always informative Multiple Sclerosis Research Blog, which is maintained by neurologists at Barts and the London Medical School in the UK (click here).

Lemtrada could be a game changing drug for many RRMS patients, particularly those hardest hit by the disease, but the drug’s risk/reward scenario may prove daunting to many patients and neurologists. It will be very interesting to see how adoption of this drug plays out over the coming months and years. Will the prospect of years without any disease symptoms whatsoever tempt patients to try Lemtrada despite the drug’s potentially serious side effect profile?

Wouldn’t it be nice if researchers could come up with a highly effective MS therapy that didn’t scare the living shit out of the patients who it is supposed to help? Perhaps in an alternate universe all forms of MS can be effectively treated with hot fudge sundaes. I hope some version of me is living in that universe.

Edited To Add: a reader who has worked with this drug in her job as an oncology nurse left the following comment, which I thought valuable enough to place into the body of this post.:

As a former oncology nurse, I am familiar with Campath and this drug scares me. You can say that it has been used in treatment for blood cancer for years, but you may not know is that it is not used often and the practice I worked for stopped giving it in our usual outpatient clinic because of severe infusion reactions. There were even deaths, although that did not happen at our facility. I treated several patients with the drug and the infusion reactions were significant. The dosage and frequency of treatment is likely very different for MS, but I have seen what it can do and it is definitely a big gun that should be used very carefully.

As I previously noted, Lemtrada (the same drug as Campath) is used differently to treat MS than it was to treat cancer, but the concerns raised are certainly valid. Infusion reactions are reactions that occur while the drug is being given intravenously to a patient. Such reactions were noted in the Lemtrada MS trials, but were not deemed to be dangerous enough to prohibit the approval for the drug for use in the treatment of active relapsing remitting MS. Still, yet another variable to consider when presented with the option of using Lemtrada to treat your disease. As always, knowledge is power, and I thank Mary Beth Knapp for contributing this information.

Edited Again to Add: the folks at the Multiple Sclerosis Research Blog have posted some very interesting and valuable information on taking the risk out of Lemtrada. One of the topics discussed are infusion reactions, so this is a very pertinent and important read (click here).

♦ There has been a lot of chatter recently about the relationship between the gut and the nervous system, with evidence pointing to a direct connection between dysfunction within the digestive system and disorders of the brain and spine. One study found a relationship between a disease known as “leaky gut syndrome” and multiple sclerosis and other inflammatory diseases, at least in mice (click here). Researchers found that mice with leaky gut syndrome had higher levels of inflammatory immune cells and lower levels of immune cells that suppress inflammation, leading those mice to suffer more severely when induced to develop the mouse version of MS (on a side note, the mouse version of MS is an absolutely horrible mimic of the human disease and I usually tend to discount almost all studies that rely on it, but in this case the findings are backed up by similar observations in people).

A fascinating article in the New York Times explored the relationship between celiac disease and disorders of the nervous system (click here). Celiac disease is an autoimmune disorder of the gut triggered by the gluten proteins contained in wheat and other grains. The article details several cases in which diseases supposedly rooted in the central nervous system, like dementia and autism, were completely reversed when patients were found to have celiac disease and put on gluten-free diets. Pretty amazing stuff, which only further fuels my suspicion that many if not most MS patients (and patients suffering from other nervous system disorders) are afflicted with some as yet unidentified systemic disease rather than one confined strictly to the brain and spinal cord. Unfortunately, modern medicine has become so specialized that each physician tends to focus only at those areas of their particular expertise when examining a patient without giving enough thought to other areas of physiology that might be impacting the patient’s condition, in effect missing the forest for the trees.

Other studies have looked at the trillions of single celled organisms that populate the gut (known as the gut biome), and found that the gut biome of MS patients is often markedly different than those not suffering from the disease (click here). Normally the relationship between our bodies and the microbes that inhabit the gut is mutually beneficial. However, it seems that in patients with MS and some other immune related diseases the mix of microbes in the gut is noticeably altered. There is so much mounting evidence that links the gut biome to MS that four major US multiple sclerosis research centers have formed the MS Microbiome Consortium to further investigate the role of the microbiome in multiple sclerosis. Turns out that 80% of our immune system is contained within our gut. Who knew?

If you find all of this interesting and who would like the chance to discover just what little buggers are residing in your gut, then you’re in luck! The Human Food Project is currently running the American Gut program, which for $99 will provide a kit with which you can sample your saliva, skin, and poop (I know, yuck) to find out precisely what microbes are living on and in you (click here). The Human Food Project will do a complete DNA analysis of your samples and return a full report. The American Gut program is a crowd funded research effort, so your $99 will not only go towards purchasing your sampling kit but also help fund this ongoing project. I ran all of this info past the naturopath who works at my MS clinic before signing up, and she said that there is no guarantee that the results of this analysis will turn up anything actionable, but that you never know. At worst I’d be helping out with a valuable research initiative. Good enough for me, so I’m currently awaiting the arrival of my saliva/skin/poop testing kit. BTW, for readers residing in the UK, there is also a UK Gut program, so all you British folks can participate as well (click here).

♦ I’ve previously written about the problem of misdiagnosing MS on quite a few occasions, and here I go again. It’s estimated that between 5%-15% of patients diagnosed with MS are not actually suffering from the disease but instead from one of the dozens of other conditions that can mimic multiple sclerosis, a notion that is quite disconcerting to say the least. I myself am suffering from some strange mix of increasingly debilitating symptoms that may or may not be multiple sclerosis, so this issue is of particular interest to me. The website EmaxHealth has recently run a series of short and easily digestible articles on this subject, all of which are worth reading. The first is titled simply “Misdiagnosing Multiple Sclerosis” (click here). Other articles in this series include “Is the Diagnosis of Lupus or Multiple Sclerosis?” (click here), “Is It Multiple Sclerosis or Transverse Myelitis?” (click here), and “Is Multiple Sclerosis Mainly an Autoimmune Disease?” (click here). As I’ve also stated previously it’s easy to drive yourself nuts with this kind of information, so be careful, but if you suspect you may have been misdiagnosed these articles could be very valuable reading.

♦ Progressive multiple sclerosis is a particularly nasty form of the disease, in which patients don’t suffer from the onset of MS attacks (relapses), but instead suffer a steady neurologic decline without ever returning to their previous level of functionality. If I do have MS, it’s of the progressive type, and I’ve been forced to watch myself go from slight limp to nearly complete gimp over the last 11 ½ years without any respite or period of stability. Take it for me, this sucks. Roughly 10% of MS patients suffer from progressive disease from the outset, a form of MS called Primary Progressive (PPMS). A substantial number of people with relapsing remitting disease (RRMS) eventually transition to Secondary Progressive disease (SPMS), at which time they stop experiencing relapses and remissions and instead start accumulating ever-increasing neurologic dysfunction. Currently, there are no effective treatments for any form of progressive multiple sclerosis.

The International Progressive MS Alliance (click here) was formed in 2012 to specifically address the vexing problems posed by progressive multiple sclerosis, and to speed up research and the development of therapies aimed specifically at this form of the disease. The Alliance recently announced the funding of 22 research projects in nine countries, all aimed at helping to unravel the mysteries of progressive MS and to eventually smite this horrendous beast (click here). Let’s hope the Alliance realizes its ambitious goals sooner rather than later, as patients suffering from progressive MS have for too long been ignored by the medical research community.

They say a picture is worth 1000 words, so a video must be worth millions, and the following video put out by The International Progressive MS Alliance sums up the horrendous nature of progressive MS and the problems the disease presents to researchers better than any of my long-winded blog posts ever could. Please watch, but I’ll try to sum up the message of the video in one word: “Help!”

♦ I’ve always found it mind-boggling that pharmaceutical companies are allowed to pay off the doctors who prescribe their drugs. Of course, these actions are never quite as blatant as bald-faced bribery, and instead these payments are dressed up as speakers’ fees, trips to educational seminars, meals provided to office staff, etc. Despite this song and dance, the fact remains that many doctors receive significant amounts of money from pharmaceutical companies, and let’s face it, Big Pharma wouldn’t be doling out all that dough if they didn’t believe it was influencing the actions of the doctors receiving their “generosity”.

If you’ve ever wondered just what kinds of gifts, honorariums, and other payments your doctors may be getting from their pharmaceutical masters (oops, I mean partners), you are now in luck, at least if you live in the USA. Courtesy of the much-maligned Affordable Care Act, a new website is now online that allows patients to enter their doctors' name, click a button, and discover just what pharmaceutical company payments their physicians received in 2013 (click here). I just entered the name of one of my physicians and came up with four pages of pharmaceutical company payments to him, most for “food and beverage” expenditures. It sure is nice to know that he and his staff are well fed.

Let me be clear, I genuinely like this doctor, but the fact that pharmaceutical companies are legally allowed to engage in this kind of crap makes me want to vomit in my mouth. Perhaps if we all print out the info we get from this website and present it to our physicians, along with some pointed questions, our esteemed doctors may think twice about engaging in such activities. Whoops, there I go, crossing over into yet another parallel universe. Silly me.

♦ Okay, now that this blog post is threatening to rival the length of Webster’s Unabridged, I’ll mercifully bring it to a close. As has become my tradition (and I really do enjoy creating my own traditions) I’ll end this edition of Bits and Pieces with a music video by an artist in the “retro-soul/neo-soul” genre. This time around I present you with Sharon Jones, a sublime belter who simply oozes all of the innumerable and unquantifiable qualities that define the notions of funk and soul. This video dates back to 2007, so I guess it’s kind of old at this point, but Sharon Jones is still going strong and deserves as much attention as she can get. Though the video looks like it was made in the 1960s, trust me, it’s a product of the 21st century, although it was shot with vintage TV cameras that its producers bought on eBay for about 50 bucks. So get ready all you cuties to shake your booties to the infectious sounds of Sharon Jones and the Dap-Kings, a righteous, mighteous, and out of sighteous infection for which I want no vaccination! Bring it on…

Thursday, October 30, 2014

Patient Taking Tecfidera Develops PML, Later Dies – Outlier or Harbinger of Things to Come?

Last week, in disclosing the company’s quarterly financial report, pharmaceutical giant Biogen revealed that a patient taking its oral MS drug Tecfidera had developed the dreaded brain infection PML and later died of pneumonia (click here). This news understandably created much anxiety in the MS population, particularly among those patients currently taking Tecfidera and those considering starting the drug. Let’s take a careful look at the details of this unfortunate news and try to properly assess its impact.

In the roughly 18 months since it was first approved by the FDA, Tecfidera has become a blockbuster drug, generating nearly $2 billion in sales over the last nine months alone (click here). The tremendous financial success of Tecfidera is in large part due to its ease of use (it’s a pill), relatively high efficacy rates, and a perceived low risk of serious side effects. Until this case of PML was reported, the Tecfidera side effects receiving the most attention were flushing and gastrointestinal distress, both of which subside after 6-8 weeks in the majority of patients taking the drug. Obviously, adding the risk of PML to the equation could change this calculus significantly, so it’s vitally important to parse this new information as best as possible to try and appreciate the true risk posed by PML in the Tecfidera MS population.

It’s essential to understand just what is PML, and how Tecfidera’s mechanism of action might increase the risk of contracting the disease. PML (Progressive Multifocal Leukoencephalopathy) is an infection of the brain and central nervous system that is caused by the JC virus, a pathogen that is present in about 50%-60% of the general population (click here). Under normal circumstances, those carrying the JC virus are completely without symptoms and the virus is kept in check by the human immune system. In patients whose immune systems have been compromised (for instance, people with AIDS),  the JC virus can lead to PML, an infection that destroys myelin in large portions of the brain, leading to significant disability, and, in many cases, death. PML is a much-publicized potential side effect of the intravenous MS drug Tysabri, which profoundly suppresses immune system activity in the central nervous system of patients taking the drug, thereby leaving those carrying the JC virus potentially susceptible to the infection. This is why strict testing for JC virus antibodies has been instituted for all patients on Tysabri therapy. PML has also been seen patients with MS as well as other diseases taking other immunosuppressive drugs, as these drugs can, by their very nature,  compromise the body’s ability to keep the JC virus under control.

Tecfidera (whose chemical name is dimethyl fumarate) is purported to work through a variety of actions. The drug is thought to have anti-inflammatory and antioxidant properties, but studies have definitively shown that one of the drug’s primary actions is immunosuppression. In trials, Tecfidera was demonstrated to reduce the amount of lymphocytes (infection fighting white blood cells) by about 28% in treated patients (click here, the pertinent information is on page 9). While this level of lymphocyte suppression is not considered to put patients at any kind of serious risk, it could very well account for Tecfidera’s efficacy in treating multiple sclerosis, as the disease is, at least in part, driven by an aberrant immune response.

These same studies also found that about 4% (1 in 25) of patients treated with Tecfidera develop a more serious drop in lymphocyte count, resulting in a condition known as lymphopenia. Severe lymphopenia can indeed open the patient up to opportunistic infections, and for this reason FDA guidelines call for regular blood testing to monitor for the condition in Tecfidera treated patients (click here). Currently, the FDA suggests patients have their blood counts checked once a year, but in practice many neurologists are being far more diligent in testing their Tecfidera treated patients. This recent news about PML and Tecfidera could very well result in more stringent blood testing requirements, but even without such a mandate it seems wise that patients be tested quite regularly to check that their lymphocyte counts remain at safe levels.

Although there currently aren’t many available details on the PML Tecfidera case reported last week by Biogen, it is known that the patient in question had been on Tecfidera for nearly 5 years (she started taking the drug during the approval trials), and had been experiencing severe lymphopenia for 3 ½ years. Logic would seem to dictate that a patient be taken off the drug as soon as their lymphocyte counts drop into dangerous territory, so the fact that this unfortunate soul was left with severe lymphopenia unaddressed for years on end is, to my mind, completely inexplicable. Indeed, it would seem that given the circumstances, her neurologist was courting disaster. Again, I am basing this assessment on scant details, but I have a hard time imagining any scenario that would warrant keeping a patient on a medication that was suppressing their immune system to dangerous levels for such an extended period of time. If the specifics of the case are as originally reported, the fact that the patient was kept on Tecfidera for three and half years after she first tested positive for severe lymphopenia quite frankly boggles the mind.

If anything, this case would seem more to underscore the importance of diligent patient monitoring than any inherent potential danger posed by Tecfidera. Ceasing the drug in the face of troubling blood test results should be a no-brainer. Patients experiencing severe lymphopenia in the Tecfidera trials saw their lymphocyte counts increase significantly within four weeks of stopping the drug. It is currently not known how long is required for lymphocyte counts to return to pre-Tecfidera levels.

While it would be extremely concerning if the patient in question developed PML while her lymphocyte counts remained at acceptable levels, the facts as now known indicate that this simply was not the case. Given the immunosuppressive properties of Tecfidera, it would appear to be vitally important that patients be regularly tested to check their white blood cell counts. It would seem that the FDA suggestion of once yearly blood tests is insufficient, and I know many neurologists are checking their patients much more frequently, more on the order of at least once every three months. Monitoring for JC virus might make sense if PML were to be seen in Tecfidera patients not experiencing severe lymphopenia, but at this point the available evidence doesn't seem to merit the taking of this extra step. Then again, any extra bit of information is valuable, and I'd imagine that some neurologists might Institute testing for JC virus in their Tecfidera patients on their own. Tecfidera is proving to be quite effective in reducing relapse rates and the formation of new brain lesions when used to treat RRMS (click here), and with proper monitoring it would appear that the drug is actually quite safe.. Of course, the drug has only been on the market for a year and a half, and only time will reveal the true long term efficacy and safety of Tecfidera.

As this tragic PML case demonstrates, the fact that Tecfidera can induce severe lymphopenia in 1 out of 25 patients taking it should make both patients and doctors alike keenly aware of the need for proper blood count monitoring. Patients shouldn’t be shy about requesting such tests if their neurologists don’t currently require them. Knowledge is power, folks, and patients need to equip themselves as best as possible with the most accurate data available and take an active role in making treatment choices. The doctor-patient relationship should be a partnership, not a dictatorship. It’s terribly unfortunate that PML has entered the Tecfidera picture, but the case in question seems much more like the exception than the rule. This is not to say that this recent news shouldn’t be cause for concern, but it certainly shouldn’t induce panic among those currently taking the drug or those considering Tecfidera therapy.

It is my fervent hope that future MS therapies will turn away from immunosuppression and find some other more effective, more benign mechanism for fighting the disease. But, as the current crop of drugs are generating billions and billions of dollars in profit for the companies that make them, it will likely be quite some time before my hopes are realized. For now, it is imperative that patients as much as possible use their heads, and, armed with accurate information, work in tandem with their physicians to best beat back the beast that is MS. At this point, Tecfidera appears to be a valuable tool in this quest, but like all tools it needs to be used intelligently and with care.

Friday, October 17, 2014

My Body, My Self

In Mel Brooks’ 1981 comedy “The History of the World, Part 1”, a scene set during the French Revolution features a member of the aristocracy rushing to tell King Louis XVI, “It is said that the people are revolting!” His Majesty quickly replies, “You said it, they stink on ice”. 

The exchange is an amusing play on words that succinctly and humorously sums up the crux of the social upheaval engulfing France at the end of the 18th century. Substitute me for the King of France and the words “your body” for “the people”, and you’ll get a pretty good idea of what’s going on inside me, both physically and mentally, courtesy my creeping paralysis. My body is in full revolt, increasingly refusing to obey my commands, and I find the situation along with my withering body itself completely repellent. My body is revolting, and it stinks on ice (not literally, I hope, for the sake of those who get close enough to smell me).

The mind-body connection is a strong one, but progressive multiple sclerosis can be a buzz saw intent on breaking that bond. As the disease advances it forces one to separate body from mind, as the “self” becomes more and more divorced from the body that serves as its vessel. Despite lofty ideals about looking beyond the physical to the person within, our sense of self can’t help but be intricately entwined with our physical state; our identities, for better or worse, are in so many ways shaped by our outward appearance, a dynamic that seems ever on the increase in a culture obsessed with beauty.

We live in a society that idolizes physical beauty to the point of absurdity, elevating the utterly talentless but extraordinarily beautiful to fame and fortune and fueling in many an obsession with physical perfection. This incessant quest for beauty has in turn birthed entire industries devoted to indulging this ravenous appetite for youthful good looks which only further feed our insatiable societal lust for flawless appearance. Billions of dollars are made catering to a population infatuated by comeliness, with cosmetics, fad diets, exercise crazes, and plastic surgery all exploding to the sound of cash registers ringing and money changing hands.

Though we pay lip service to the idea that beauty is only skin deep, study after study has shown that in modern Western society those perceived as physically attractive have a quantifiable advantage over those not similarly blessed. There are, of course, exceptions to the rule, and beauty is by no means a sure ticket to happiness. Indeed, for some it can become a curse – think Marilyn Monroe – but our popular culture covertly and overtly continuously pounds home the message that the spoils of life most often go to those deemed gloriously pretty or handsome. I’m not sure that anyone can be immune to this pervasive zeitgeist, and I certainly was no exception back in my healthy days, although my relationship with my body even pre-MS had a long history of discord.

Growing up I was as skinny as they come. I’m not talking merely thin, I’m talking Boney Maroney, stick figure, almost comically scrawny. In addition to earning the nickname “Bones”, until I was 15 or so I was also quite short, and as a skinny little pipsqueak I was often subject to teasing not only by other kids but sometimes by adults as well. While it’s considered bad manners in grown-up circles to talk about a heavy person’s weight, it seems no such taboo exists when it comes to the extremely thin, regardless of their age. Being teased by other kids was bad enough, but in response I quickly developed a smart and scathing wit with which to defend myself from their juvenile barbs. Hurtful comments made by adults, though, always struck home hard, and I can still vividly remember some of the most boorish comments directed my way by adults who should have known better, the combined effects of which spawned massive insecurities that persist to this day.

A sudden growth spurt when I was about 15 years old took care of the pipsqueak part of my problem, but I remained superduper skinny for years to come. When I graduated college I was 6 feet tall and weighed in at a whopping 120 pounds soaking wet. Fortunately, sitting atop that emaciated frame was a face that was kind of cute, and much to my delight and amazement I discovered that there were women who actually like skinny men. I naturally gravitated towards artsy social circles and wound up the lead singer of a punk rock band, a role in which thin was most definitely in. In the underground music scene in the 1980s there was more than a touch of heroin addict chic, and I had the decided advantage of being as thin as a junkie without actually having to take drugs. I’d managed to find a social scene in which my being the skinniest guy around was actually an advantage. Go figure.

My body finally filled out in my late 20s, but I always remained on the thin side. Nobody was ever going to mistake me for Adonis. Although I was considered attractive, and was sometimes even called handsome, the insecurities that first took root when I was a skinny little nebbish lived on and I fought hard to overcome a shyness that at times bordered on social anxiety. I’ve been told that some found me aloof or even standoffish, but in reality I more often than not was quaking in my boots. That scrawny little 10-year-old was never far from the surface, a mind-body connection that persisted far into adulthood even though it no longer reflected my physical reality.

Now an entirely different kind of mind-body connection, or, more correctly, a mind-body disconnection plagues me. Just around the time that I had become comfortable in my own skin – thank you, decades of psychotherapy – a little problem called multiple sclerosis reared its ugly head. While walking my pooch along the Hudson 11 ½ years ago, I developed a slight limp in my right leg. All too soon that limp was joined by a weakening right arm, and whatever dastardly bastard was causing this distress refused to release its grip. Fast forward a decade plus and this beastly disease has just about fully consumed my right side and is gluttonously munching away at my left. My mind reels in horror at the damage that has already been done and can barely stand to contemplate that which may lie just beyond the horizon. But the me that existed before my illness struck still resides within, inevitably changed by the experience but ever yet struggling to maintain itself.

In a situation surreal but all too real, I find myself (and my self) trapped in a body that increasingly not only refuses to obey my wishes but seems to have a mind of its own. I sometimes put my disease to the test, concentrating intently, face contorted with effort, commanding my right ankle to flex, but much to my overwhelming chagrin and frustration, nothing ever happens. Absolutely nothing. Many nights, though, just about the time when I’m ready to go to sleep, my entire right leg will shudder and quake in muscle spasms beyond my control, violent enough to shake the bed frame, the tremors coming in waves every 30 seconds or so for hours on end despite the pharmaceutical cocktail meant to quell them. All the while, inside, buried deep within the emotional maelstrom brought on by my illness, lays a big kernel of the old me, observing it all in utter disbelief.

Since the onset of my disease, the divide between my essence and the body that contains it has grown from a slight fissure into a great chasm. I’ll occasionally struggle from my wheelchair to stand in front of a mirror, trying to strike a pose that suggests some semblance of normalcy, imagining that if someone were to glimpse me at that precise moment they might not guess I was so afflicted. But then I see in my reflection that my right arm has withered, the fingers on my emaciated right hand curl unnaturally inward, and my right wrist and elbow stay unbent only by my precariously lodging them against the side of my body. In shorts my legs reveal themselves to be sticks, as if they remembered who they were back in my skinny youth and decided to reprise the role. My once lean stomach has become a bulbous belly, courtesy years of sitting in a wheelchair. This is not the me that I hold in my mind’s eye, and yet this is the reality of the body I now possess, a body that will become only more and more unfamiliar with time barring some incredible medical intervention.

This decrepit circumstance has forced me to break the mind-body connection that we are so conditioned to accept as reality. Though I struggled to embrace my physical self in my younger days, I must reject the physical decay that now besets me, as for sure this defective mass of flesh and bone does not define me. My mind remains sharp, maybe too sharp, and my sense of self is more pronounced now than ever, albeit in an increasingly disembodied state. I don’t know if consciousness survives our ultimate physical demise, but I do know that the essence of who I am is increasingly independent of the physical form that maintains it.

In a strange paradox, I have become more sure of the person I am these days than I ever was back when my body was whole. I’m privy to insights I likely never would have attained if not for my unfortunate situation. It’s a strange life, this existence within an existence, but it is life nonetheless, not one I ever would have chosen but one in which holds within it not only sorrow and frustration but also still moments of contentment and sometimes even joy. Along with my sense of self those two most vital elements of life, joy and contentment, have by necessity undergone their own bits of revision, reshaped and reimagined by a me that more and more severs the connection between body and mind.

My body is revolting, and yes, you said it, it stinks on ice… Ha!

Monday, September 29, 2014

Bits and Pieces: Autumn Equinox Edition (also Tysabri, MS and HIV,viruses, relapse rates, misdiagnoses, diet, and asinine research)

Personification of Autumn (Currier & Ives lith...

Personification of Autumn (Currier & Ives lithograph, 1871) (Photo credit: Wikipedia)

Well, according to the full scale replica of Stonehenge that I have sitting in my living room (which is right next to my exact copy of the Sphinx and down the hall from my faux Taj Mahal – it’s incredible what you can fit in a 900 ft.² apartment with a little ingenuity) summer is over and autumn is now upon us. Time for packing away the seersucker, preparing for the harvest, and getting ready for the ceremonial sacrificing of virgins. Luckily, there are no virgins available in my apartment, so we’ll probably make do with sacrificing some gourmet chocolates.

Wish I could say I had an exciting summer, but this one was actually quite dull. A big shout out to Multiple Sclerosis for that one, as the beast has been heavy-handed with me these last few months. Even though I have progressive disease and the overall trajectory of my symptoms is always steadily downward, their severity does tend to inexplicably wax and wane a bit. The last few months they’ve definitely been waxing, and boy, I’m more than ready for a little wane – and I’m not talking about L’il Wayne, the notorious hip-hop artist (click here).

Alas, my replica of the Temple of the Oracle at Delphi tells me that it’s time for another edition of Bits and Pieces, my semi regular compendium of interesting MS related news and notions. Can’t argue with the Oracle at Delphi, lest mighty Zeus unleash a lightning bolt in my direction, and really, I have enough problems. So here goes…

♦ First up, some MS drug news. A study out of Italy has found that Tysabri is even more effective in real life clinical practice than it was during the trials that led to its approval for use in treating RRMS (click here). This study of 343 patients from 12 Italian MS centers found that, over time, treatment with Tysabri resulted in a 68% reduction in MS relapses, that 93% of treated patients saw no disease progression, and that 53% of Tysabri treated patients were free of any signs of disease activity. Very impressive numbers, to say the least, despite the fact that Tysabri is not without its concerns (chiefly the possibility of contracting opportunistic infections, primarily PML, a potentially fatal infection of the brain).

When Tysabri was first introduced I was highly dubious of the stuff, thinking that the drug’s dangers far outweighed its potential benefits, but I must admit that time has, it seems, proven me wrong. I personally know a quite a number of RRMS patients whose lives have been dramatically improved by Tysabri, some so much so that they refuse to come off the drug even after developing a higher risk of contracting PML. I’m still not entirely comfortable with the idea of screwing with the workings of the human immune system for years on end, and it pisses me off immensely that medical science (or at least the pharmaceutical companies) seems content at treating the disease rather than curing it, but if I was a newly diagnosed RRMS patient with a low risk of developing PML (in other words, negative for JC virus antibodies), given all of the available data starting Tysabri would certainly high on my list of treatment options. That's honestly something I thought I'd never say six or seven years ago. There are currently trials ongoing testing Tysabri on progressive disease, and it will be very interesting to see how those turn out.

♦ There’ve recently been a spate of headlines to the effect that “HIV May Help Prevent Multiple Sclerosis” (click here). The basis for these headlines is a study that looked at MS rates among people infected with the HIV virus (the virus that causes AIDS), which found that HIV-infected people were far less likely to develop Multiple Sclerosis then the general population (click here). What could be behind these shocking findings? Well, it’s certainly possible that the HIV virus itself has some kind of anti-MS properties. It’s also possible that HIV, which can do serious damage to the human immune system, suppresses the aberrant immune cells that are thought to lead to the development of Multiple Sclerosis. More intriguing, though, is the possibility that the anti-retroviral drugs given to treat HIV patients, which have become extremely effective over the last decade, may be doing something to curtail the development of MS in HIV infected people.

About a year and a half ago I wrote about an emerging theory that ancient retroviruses which have become part of human DNA over millions of years of evolution may be behind a variety of illnesses, including cancer, schizophrenia, and, yes, so-called autoimmune diseases like Multiple Sclerosis (click here). These ancient viruses are in the same class of virus as HIV, called retroviruses. Long thought to be simply “junk DNA” and merely innocuous remnants of the ancient past, it’s recently been found that some of these viral bits, which are part of every human beings’ genetic structure, might be activated by the presence of certain environmental factors (other viruses, bacteria, or toxins), and thus cause all kinds of trouble. This hypothesis provides an elegant explanation of autoimmunity, in that, if correct, it would mean that under certain conditions our own cells might act as attackers, thus initiating a response by our body's own immune system.

Could it be that the powerful antiretroviral drugs being given to HIV patients are shutting down these ancient retroviruses (called Human Endogenous Retroviruses, or HERVs), and so are preventing the HIV-infected people on these drugs from developing Multiple Sclerosis? An intriguing possibility, and one which is currently being investigated by a group in London who are using some off-the-shelf HIV drugs to treat MS patients in a trial that is now underway (click here). Additionally, another related trial being conducted by a research group in Switzerland is testing a drug specifically designed to target an ancient retrovirus that has been linked by some scientists directly to Multiple Sclerosis. This group recently released the results of a small preliminary trial which tested the drug on progressive MS patients and showed it to be safely tolerated. Furthermore, the trial demonstrated some early indications that the drug may be effective in treating the disease (click here).

This is exciting stuff which could potentially change the way we view and treat many dread diseases in some very profound ways. My gut tells me that there is really something to this research, and I only wish more time, money, and effort was being devoted towards fully exploring this hypothesis and its many implications.

♦ Yet more research on viruses and MS: a recently released study using new testing methods found that the spinal fluid of Multiple Sclerosis patients is rich in antibodies targeted at Epstein-Barr Virus (EBV) and Human Herpes Virus-6 (HHV-6), rather than against human myelin and nervous system tissues, as might be expected if MS were truly an “autoimmune” disease (click here). Epstein-Barr Virus, and to a somewhat lesser extent HHV-6, have long been suspected in playing some role in the MS disease process. Fascinatingly, both of these viruses have been implicated in activating HERVs , the ancient retroviruses that I discussed in the previous item. Could it perhaps be that in genetically susceptible people, common infections such as EBV (which is carried by more than 90% of the population) can turn on DNA switches that lead the immune system to attack tissues of the central nervous system? In the decades before the autoimmune theory took hold, much of MS research was directed at finding the presumed infectious cause of the disease. Perhaps these now discounted theories were in fact on the right track, and strict adherence to autoimmune dogma over the last 20 years has led MS research astray. Again, clues like those divulged by this study demand that more attention be paid to this area of research.

♦ Here’s one that belongs in the MS version of Ripley’s Believe It or Not. The gold standard of medical research is the double-blind trial, in which one group of patients is given whatever treatment is under study and another is given a placebo (such as a sugar pill or saline solution), so that the responses between the two groups can be compared. In MS research, one of the most common measures by which an experimental drug’s efficacy is judged are annual relapse rates, the number of MS attacks experienced by relapsing remitting test subjects over the course of a year. Strangely, over the last two decades the annual relapse rates of patients in the placebo arms of late stage drug trials has dropped by half (click here). That’s right, since the 1990s the rate of relapses experienced by patients being given “fake” drugs has declined by 50%, while the rates of people getting MS worldwide have gone up (click here). And no one knows why. Isn’t that reassuring?

♦ Some more reassuring news: I came across a list of the 15 most misdiagnosed diseases (click here), and wouldn’t you know it, our good friend and close confidant Multiple Sclerosis is right up there. Given the many mysteries surrounding MS and the fact that there is no diagnostic test that definitively determines whether or not a patient does indeed have MS, this really shouldn’t come as much of a surprise. Truth is, most experts peg the misdiagnosis rate of MS at somewhere between 5%-15%, meaning that perhaps 1 out of 10 of the MS patients reading this don’t actually have the disease. There are literally dozens if not hundreds of diseases and conditions which can mimic MS. Here’s an academic paper on the subject, which lists at its end 100 illnesses that can be mistaken for MS (click here). It’s easy to drive yourself crazy with such information, so be careful, but if you suspect you may have been misdiagnosed, there’s a reasonable chance that you could be right.

♦ The relationship between diet and MS has become a very hot topic of late. Through the years, many different diets have been said to be “anti-MS”, most often low-fat or low-carb diets rich in anti-inflammatory and antioxidant foods. In fact, I’m currently trying the Paleo diet, a way of eating that is supposed to resemble the dietary habits of our ancient ancestors. The theory is that the function of our digestive systems evolved over the millions of years that our forebears were hunter gatherers, and that much of what we’ve taken to eating since the discovery of agriculture some 10,000 years ago is actually bad for our health. The Paleo diet cuts out all sugar, dairy, wheat, and some of the most common cultivated crops. This means that people on the diet can’t eat bread, milk, cheese, rice, potatoes, corn, or many of the other staples of the modern menu.

Given the fact that I’m giving Paleo a try, my interest was quite peaked by this article (click here), which details the results of a study that followed dietary habits of 185,000 women over 20 years and found that diet seems to have absolutely no impact whatsoever on whether or not they developed Multiple Sclerosis. In fact, the numbers appeared to show that those eating what is considered to be an unhealthy Western diet developed MS in lesser numbers, although this trend did not reach statistical significance.

Now, I know there are many patients who swear that a radical change in diet has noticeably lessened the impact of their disease and some have gone as far as to claim that diet can even cure MS, and I’m certain that most of these claims are made in all earnestness. I'm not saying that this study is the last word on the subject, but it should provide food for thought (pun intended). At the very least a healthy diet is, well, healthy, and that can only be a good thing especially for people suffering from chronic illness. And for those who are wondering how I’m doing after more than two months on the Paleo diet, I’m sorry to report that I’m feeling pretty crappy, worse, I think, than before starting the diet. I have dropped a few pounds, which is definitely good since I was beginning to resemble a walrus (sitting in a wheelchair does nothing for the physique), but given my lack of results otherwise I believe my time eating like a caveman may be drawing to a close. I’m thinking that the next diet I try might be one of my own invention, which I dub the “Nothing But Philly Cheesesteaks Diet”. Probably not very healthy but… Yum.

♦ Okay, time for yet another edition of ASININE RESEARCH! Once again, I present another in apparently endless stream of studies that that delve into the ever enigmatic conundrum that is the relationship between multiple sclerosis, difficulty walking, and falling down. This topic really seems to float the boats of top-notch medical researchers who apparently can’t get enough of publishing papers probing the seemingly unfathomable relationship between a crippling disease and its patently obvious effects on ambulation.

Today’s asinine research paper is tantalizingly titled “Concern about Falling Is Associated with Step Length in Persons with Multiple Sclerosis” (click here). The abstract starts out with this sentence: “Fear of falling is one of the major concerns of people with multiple sclerosis.” Yes, yes, a dazzling observation! And fear of ruining ones undergarments is one of the major concerns of people suffering from explosive diarrhea. From this auspicious start, the paper goes on to detail research looking at how concern about falling alters the way MS patients walk. While investigators suffering from severe oxygen deprivation might assume that MS patients stride like Rockettes and strut about with all of the bravura of a young Mike Tyson, after much mumbo-jumbo about “spatio-temporal parameters of gait” and “gait asymmetry patterns” this study instead shockingly finds that multiple sclerosis patients tend to walk slower and take smaller steps than their healthy counterparts, and that this astounding effect is greater in those with a higher fear of falling. The study concludes by postulating that measuring step length might be a good tool for assessing the level of fear of falling in people with MS. I suppose assessing the level of terror on their faces is just too bothersome.

Did it ever occur to the researchers that MS patients walked slower and took smaller steps as a result of the disease, and that this might in fact be the reason behind their fear of falling and not the other way around? I certainly don’t remember having a healthy fear of falling before, you know, the disease took a hammer to the connection between my brain and my legs and left me no choice other than to walk slower and take smaller steps. In fact, these days if my steps get any smaller or my walking gets any slower my attempts at ambulation might better be termed "standing still". Yes, this all makes for a frightening experience, but it's not the fear that keeps my legs from moving, it's some little-known phenomena called "weakness" and "paralysis". Sheesh.

♦ It’s become my custom over the past several Bits and Pieces posts to end with some music from the “Neo-Soul/Retro-Soul” movement. Words can’t express how smitten I am with much of this music, which never fails to put some funk in my junk, some glide in my stride, some pep in my step, and some growl in my prowl. Hey, wait a minute, as mentioned above these days I can barely manage a stride, step, or prowl, so I’ll have to amend that – this funky stuff puts some chimp in my limp, some jumble in my stumble, and some gall in my fall. Can I get an Amen? Hallelujah!

The following ditty is by St. Paul and the Broken Bones, a band I was lucky enough to see at a free concert outside of Lincoln Center a few months ago. I went to the show primarily to see Charles Bradley, who I featured in a previous Bits and Pieces, but I was unexpectedly blown away by these guys, who I’d never heard of before they took the stage. As I mentioned earlier, this summer wasn’t a particularly terrific one in my book, but this show was definitely a highlight…