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

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…

Bits and Pieces: Neurologists' Conference Edition (also: Tysabri,Tecfidera, Marijuana, Mold, Asinine Research, and other goodies)

(For those who receive Wheelchair Kamikaze via email, the following post contains videos which can be seen on the WK website – click here)

It’s time once again for Wheelchair Kamikaze’s semi regular compendium of MS news and notes.

Last week the American Academy of Neurology (AAN) held its annual meeting, this year held in Philadelphia. This weeklong event brings together some of the world’s best minds in neurology, and features presentations on all the latest and greatest research. I found it quite striking that this year’s multiple sclerosis presentations almost all had to do with information gleaned from drug trials, but since practically all mid to late stage medical research is conducted by the big pharmaceutical companies, I guess I shouldn’t be surprised. Most of the fault lies not with the drug companies themselves, but with the system within which they operate, which has handed these companies the reins of medical scientific investigation as governments and academia are increasingly less able to fund research due to the current political and economic climate. As a result, our medical research model is becoming more and more dysfunctional, with many potentially paradigm shifting basic research studies never making it out of the lab. Yippee!

I sometimes think about how strange life must be for neurologists who specialize in the most debilitating diseases of the nervous system, none of which have yet to be sufficiently remedied. Doctors practicing most other areas of medicine can look with satisfaction on the patients they’ve cured, but many neuros can spend their entire careers without ever having rid a patient of disease. I can’t help but imagine a group of specialist neurologists getting together at their annual meeting and quickly summarizing the major clinical advances of the past 12 months. “Let’s see, have we cured Parkinson’s disease?” “Nope…” “Okay, how about Huntington’s disease?” “Nope…” “Multiple sclerosis?” “Nope…” “Alzheimer’s?” “Nope…” “Muscular dystrophy?” “Nope…” “ALS?” “Nope…” “Right then, that sucks.... Anybody else really need a drink?…”

Okay, enough of my mental meanderings, here’s my latest collection of mostly MS related research and news, selected solely on the basis of what I deem to be important and/or interesting. Hey, it’s my blog and in this little corner of the Internet I rule with an iron fist. Actually, given my current state of physical decrepitude I’m not sure I could properly muster an iron fist, so I guess I’ll have to be satisfied ruling with a less than formidable half assed fist. Hey, we’ve gotta play the cards we’re dealt…

♦ First up, a sampling of the MS drug news that came out of the AAN meetings. Tysabri was shown to positively impact walking speed in some patients (click here). While at first glance this sounds impressive and could be an indicator that the drug has a positive impact on disease progression, digging down a little deeper leaves me less than knocked out. Slightly over 12% of patients on Tysabri demonstrated improved walking speeds over the course of two years of treatment, which really isn’t bad, but about 7% of patients treated with a placebo also managed a significant improvement in walking speed, which just goes to show you how variable is the nature of relapsing remitting MS. Tysabri did prove to be about 80% better than placebo in this regard, and since most patients would gladly settle for a state of stasis in their disease, any signs of improvement are a big plus. Researchers did find that this effect was more pronounced in patients with more advanced disability, with walking speed increased by as much as five times when compared to placebo in this patient group, which does make the research more compelling.

A small phase 2 trial of Tysabri on SPMS patients came up with encouraging outcomes (click here). In this study, 24 SPMS patients were treated with Tysabri for 60 months, and levels of osteopontin, a marker for inflammation, were tracked in their cerebrospinal fluid. Several other biomarkers were also tracked, and after 60 weeks of treatment statistically significant decreases in markers for inflammation, axonal damage, and demyelination were recorded. These are impressive findings, especially since there are currently no proven treatments for secondary progressive disease. Of course, these results will have to be replicated in larger trials, but this seems to be an encouraging start.

♦ In Tecfidera news, the oral MS drug was shown to be effective when used on patients with highly active disease, reducing annual relapse rates by 60% and the proportion of patients who relapsed by 63% when compared to placebo (click here). I know that many patients are concerned about Tecfidera’s uncomfortable side effects, and a study looking at gastrointestinal side effects in patients taking the drug found that “GI events were largely transient, occurred most frequently in the first month of therapy and were mostly reported as mild to moderate in severity. By the 10^th week of treatment, less than 10 percent of patients reported GI AEs. The incidence of discontinuation due to GI-related AEs was low (7.3 percent).”

There has been much conjecture as to Tecfidera’s primary method of action (in other words, why it works), and a study out of Germany demonstrates that the drug keeps certain immune system cells out of the central nervous system (click here). It’s already been established that Tecfidera has immunosuppressive properties, and it is suspected that the compound also has anti-inflammatory and antioxidant properties as well. Based on the latter suspected properties, some have speculated that the efficacy of Tecfidera could be replicated using a combination of dietary supplements, but since immunosuppression seems to be the drug’s primary method of attack such an approach likely wouldn’t duplicate the effectiveness of the drug.

♦ Okay, let’s turn away from the world of pharmaceuticals and take a look at some recent research regarding more “natural” approaches at treating MS. Green tea has long been extolled as a powerful antioxidant, and a recent study demonstrated that green tea extract has a positive impact on cognitive function (click here). In this small study, healthy volunteers were given green tea extract and then asked to do memory tasks while undergoing functional MRI imaging. The imaging showed that the extract appeared to improve conductivity between certain areas of the brain, and these areas correlated with improved memory function. Happy to hear it, as I take green tea extract every day…

♦ The human gut is home to a wide variety of bacteria, which are known to help with the process of digestion. Doctors have noted for some time that there seems to be some correlation between the gut and so-called autoimmune diseases, and a recent study bears this out (click here-registration may be required, but it’s free and well worth it). Researchers compared the microorganisms contained in the guts of MS patients with those found in healthy subjects, and discovered that MS patients have higher levels of a bacteria that is known to stimulate the immune system, and lower levels of two other types of microorganisms that excrete anti-inflammatory substances. Fascinating findings, I think, which definitely hint at reasons for an immune system gone haywire. Just goes to show how many different elements come into play in the complicated MS disease puzzle, and how many different approaches might be taken to treat the illness.

♦ Here in the US, more and more states are legalizing medical marijuana and a few are even making it legal to use the stuff for recreational purposes. Ganja has been touted as an effective treatment for MS spasticity and muscle spasms, and a recent review done by the American Academy of Neurology gives such notions the official stamp of approval (click here). The AAN found that the demon weed does indeed reduce spasticity and muscle spasms, and the pain associated with these symptoms.

I’ve recently been plagued by an uptick in spasticity and muscle spasms, and the spasms in particular have been driving me crazy. So, though Mary Jane is still illegal in New York State even for medicinal purposes, based on the above study I decided to imbibe in a little reefer madness. Lo and behold, my spasms took a powder and my spasticity loosened its grip.

Truth be told, even as a teenager I was never much of a stoner, though wild and unsubstantiated rumors have it that I occasionally imbibed in some other illicit substances back in the quixotic days of my wayward youth. Hey, I was a teenager and young adult in the 70s and 80s, which were the “say yes to drugs” era. Anyway, as far as sparking up a little boo goes, based on the above study and my own anecdotal experience I see no reason not to give it a try, but if you do, don’t Bogart that joint, my friend…


BTW, despite what the video says, the song is by the band Fraternity of Man, not Country Joe and the Fish. My guess is the person who made the video was probably all goofed up on muggles when they put it together.

♦ Another recent article I came across touched close to home. Between 1993-1995 I worked in a “sick” building which eventually needed to be decontaminated by experts in hazmat suits. In a despicable attempt to save money, the bastards who comprised my company’s upper management withheld a report that said that our building was rife with all kinds of molds and bacteria. I’ve long suspected that my exposure to these nasties played a role in my developing much of the physical crap I’ve been dealing with over the last 15 years or so, and a recent article by an environmental hygienist might just validate my suspicions (click here). The article claims that toxic mold has been associated with MS and other autoimmune diseases, and a quick search around the Internet yielded a few other pieces making similar connections (click here). Granted, the article that originally caught my attention was written by somebody who profits from diagnosing sick buildings, but it isn’t hard to imagine that being exposed to all kinds of toxic muck for an extended period of time could lead to a wide variety of medical problems. And the kicker is that I hated that freaking job…

♦ The good folks at Healthline.com have put together a page full of infographics illustrating “Multiple Sclerosis by the Numbers: Facts, Statistics, and You” (click here). The page delves into statistics and information related to MS disease prevalence, risk factors, and the frequency of the different types of MS, along with symptoms and treatment options. It’s a great primer for all things MS, and highlights some interesting and beguiling facts about the disease. I think my favorite illustration is this one, which starkly demonstrates just how more prevalent MS is in northern regions than southern, using a map of the United States as an example.

The above Infographic shows that people living in the northern half of the US are just about twice as likely to develop MS as those living in the southern states. The Infographic doesn’t go into some other interesting elements regarding the regional effect on MS, such as the fact that people moving from north to south before the age of 15 take on the lower MS risk factors associated with the southern region, while those moving after the age of 15 retain the North’s higher risk of MS. Riddle me that, Batman…

♦ Okay, it’s time once again for one of my favorite topics (drumroll please), ASININE RESEARCH! Scientists from the University of Kansas heroically decided to tackle the following mindbending question: “Is there an increased risk of hip fracture in multiple sclerosis?” (click here). My God, of all of the mysteries associated with MS, finally – finally – paid researchers have valiantly taken on a question that folks with even the scantest knowledge of the disease could answer in about two seconds. Wait – before I divulge their findings, please take a fraction of a second and see if you can guess the answer to this most vexing of inquiries.

Okay, after spending a few microseconds contemplating whether or not multiple sclerosis – a disease that can weaken limbs and thus make walking a bit, um, treacherous – might lead to an increased risk of hip fractures, did you come up with the startlingly radical answer of “yes”? If so, kudos to you, you are now an official multiple sclerosis researcher. You can pick up your certificate at the nearest sandwich shop.

Indeed, after reviewing over one million (!) hospital records of hip fracture admissions spanning a period of 20 years, our stalwart investigators found that MS patients were over twice as likely to suffer hip fractures than the population at large!!! Shocking, no? I mean, who could have possibly surmised that a disease whose symptoms include muscle weakness, spasticity, paralysis, numbness, and balance issues could ever lead those afflicted with it to fall down and break their hips? I only wish the researchers had been able to quantify just how more likely MS patients were to suffer scraped knees and bruised elbows. Inquiring minds want to know!

While I wait on tenterhooks for those revelations, let me try to save future researchers a whole lot of time and effort by answering some other enigmatic questions: Do people with MS have an increased number of visits to neurologists? Yes! Do bladder frequency/urgency issues lead people with MS to spend a ridiculous amount of time in the bathroom? Wait a second, I'll tell you as soon as I get back from the loo... Do bears shit in the woods, is the Pope Catholic, do some researchers seem to have nothing better to do than waste time and money for no apparent reason other than my amusement? Why, yes, yes, and yes! Now which sandwich shop do I go to to pick up my Nobel Prize?…

♦ I leave you, dear readers, with the following music clip, by the British artist Paolo Nutini. I’ve been listening to a lot of the new “retro” Soul and R&B, the best of which captures the spirit of the great music that was made between the mid-60s and early 70s. Being 50 and an old fart gimp who is almost completely divorced from pop culture, this new music has come as something of a revelation, like mana from heaven. Before running across the song, I was completely unaware of Paolo Nutini, but since the video has almost two million hits I suppose I missed something somewhere along the way. From what I can gather, Mr. Nutini is much better known in the UK than in the US, but then again, he could be a household name among twentysomethings here in the states and I’d never know it. Anyway, I think it’s a great song that definitely has that indefinable element called “soul”. It also includes a spoken word piece that comes from a speech in the 1940 Charlie Chaplin film The Great Dictator, a monologue which is as relevant today as it was 74 years ago. The Chaplin clip is well worth googling if you’ve never seen/heard it. I hope you enjoy the music…

Bits and Pieces: 1,000,000 Page Views Edition (Also: Lemtrada, Tysabri Risk/Reward, and Asinine Research)

Eyeballs (Photo credit: Skrewtape)

(If you have received this via email, the following post contains a slideshow and a video, which can be viewed on the Wheelchair Kamikaze website. Please (click here) to view the multimedia content on your web browser.)

Gadzooks! Zounds! Great Gooble Gobble! Late last week Wheelchair Kamikaze received its one millionth page view. 1,000,000! I’m absolutely gob smacked, even though I’m pretty sure about half a million of those page views can be directly attributed to my mother.

In the nomenclature of the Internet, each page view is just what it sounds like, an instance when somebody finds their way to a specific website through a search engine or link and gives it a peek. So, in the four years and 11 months since its inception, my modest little abode on the Internet has been looked at by folks 1,000,000 times, a figure which truly boggles my mind. People from all over the world have visited this place; the stats provided to me by Google show that in the last month alone Wheelchair Kamikaze has been frequented by people in (in alphabetical order): Australia, Belgium, Canada, China, Costa Rica, The Czech Republic, France, Germany, Iraq, Israel, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, United Kingdom, The United States, and Venezuela. Holy crap!

In all honesty, I never expected more than a couple of dozen people to ever look at this thing, as when I started Wheelchair Kamikaze I wasn’t even all that sure of what a blog actually was. I’d been quite active on several online MS forums for a number of years, and during that time several fellow forum members intermittently urged me to start writing a blog, a notion to which I wasn’t all that favorable. I’d never really ventured into the “blogosphere”, and my conception of what a blog could be was fairly limited. In my mind a blog was pretty much just a sort of online diary, and I really didn’t think that what I did or thought would be of interest to anybody outside of the small sphere of human beings who actually knew me.

It wasn’t until my sorry ass landed in a wheelchair, and, at my wife’s urging, I attached a camera to that wheelchair and made a few videos of my wheelchair rides through Manhattan – which friends and family found amusing – that the idea of staking out my own virtual homestead took hold. Okay, I thought, a blog could provide me a place to house the videos and photos I took from my wheelchair, and maybe the occasional scribble or two, in a spot that would be easily accessible to the relatively few people who knew I existed. Never in my wildest dreams did I imagine that this site would provide a conduit through which a part of me could reach out and touch people all over the world, and that in turn these virtual connections would enrich my life in ways that are literally beyond words.

Wheelchair Kamikaze has provided a kind of method to the madness of my being stricken ill, and has many a time proven to be a lifeboat of sorts, helping me keep my head above the churning, tempestuous psychological waters of dealing with my chronic progressively disabling disease. For that I am more than grateful, and to all of the wonderful people who have contributed to those 1,000,000 page views I offer my most humble gratitude, which hardly seems sufficient given the remarkably positive impact creating this blog and interacting with those who view it has had on my life. It may be overstating it to say that Wheelchair Kamikaze has been my salvation, but it wouldn’t be overstating it by much. So, thank you, thank you, thank you.

Okay, with that bit of mushiness done with, let’s get to the business at hand, a rundown of various pieces of MS related news that have garnered my attention over the last few months or so. As usual, these pieces range from the sublime to the ridiculous, and I hope you’ll find them pertinent, useful, interesting, and/or amusing. On with the show…

♦ A new MS drug called Lemtrada has been approved for use in Canada (click here), Australia (click here), and the European Union (click here), but, surprisingly, not here in the United States, where the FDA rejected Lemtrada’s application for approval (click here). The FDA’s rejection comes as something of a shock, as it was widely expected that Lemtrada would receive the FDA’s authorization, despite the problematic side effect profile of the drug.

Lemtrada isn’t actually a new drug; in a previous incarnation, when it was called Campath, it had been used successfully to treat leukemia and lymphoma since 2001. The drug is a monoclonal antibody, a member of the same family of drugs as Tysabri, and works by dramatically depopulating immune system cells in treated patients. Lemtrada is so effective in wiping out its immune cell targets that it in effect prompts the body to “reboot” the immune system, much the same way that certain stem cell therapies attempt to do. The idea is relatively straightforward – wipe clean a person’s immune system, in the hopes that when that immune system is reconstituted it will no longer have an appetite for the patient’s own central nervous system cells. This relatively straightforward concept has proven somewhat tricky to pull off in practice, but Lemtrada does seem to accomplish this feat over an extended period of time.

When used to treat MS, Lemtrada is given intravenously in five day courses two or three times over a 12 month period. After this initial one-year period of dosing, clinical trials have shown Lemtrada to be remarkably effective when given to relapsing remitting patients with active disease. One study (click here) showed that five years after treatment 65 percent of such patients were free of clinically active disease, 72 percent were relapse free, and 87 percent of Lemtrada treated subjects were free of sustained accumulation of disability. In other words, five years after treatment, well over half of the patients given Lemtrada showed virtually no signs of multiple sclerosis activity – they were, for all intents and purposes, MS free.

What then, is the problem? Unfortunately, Lemtrada’s effectiveness comes at a price. Approximately 30 percent of Lemtrada treated patients develop autoimmune thyroid disease, which, though not to be pooh-poohed, can be effectively treated using conventional therapies. More disturbingly, some patients develop an autoimmune blood disease called immune thrombocytopenia (ITP), which, if not caught in time, is often fatal. Patients can be effectively monitored for ITP, but the fact that Lemtrada leaves patients susceptible to the potentially deadly disease is problematic, to say the least.

In those places where it has been approved for use, Lemtrada poses RRMS patients quite a dilemma. Is the prospect of being disease-free five years after treatment worth the risks associated with autoimmune thyroid disease and ITP? Quite the conundrum, but I would think that at least some folks being ravaged by highly active MS, experiencing relapse after crippling relapse, would certainly be willing to take the risk. As we’ve seen with Tysabri, patients can be quite tolerant of risk when a drug dramatically increases their quality of life. It will certainly be interesting to watch as the Lemtrada saga plays out in the regions that have given it approval.

Just as a side note, Genzyme, the drug company that manufactures Lemtrada, engaged in some sleazy activity several years ago by pulling Campath off the shelves when it appeared that the drug – newly named Lemtrada – would sail through the approval process for use as an MS therapy (click here). Why pull Campath off the shelves? Because Genzyme planned to dramatically hike the price of the drug when they changed its name from Campath to Lemtrada and switched focus from leukemia/lymphoma patients to those suffering from MS. When used to treat leukemia or lymphoma, a typical course of Campath treatment cost about $60,000. Since MS patients would need a far lesser dose of the drug, the cost for a course of multiple sclerosis treatment would only be about $6000. So, Genzyme made Campath unavailable and only planned to reintroduce it as Lemtrada once it was approved for use in MS patients, at a dramatically higher price, of course. 

Although the drug has been approved in Canada, Australia, and EU, those places restrict the price of drugs, something that is unheard of in the US, where drug companies can pretty much charge whatever they please. And now the FDA has failed to approve Lemtrada, foiling Genzyme’s Machiavellian business plans. What goes around comes around, as they say…

♦ Having mentioned Tysabri and the fact that it improves the quality of life for many of those taking it, here are two studies that illustrate just that. One study (click here) shows that Tysabri treated patients require less sick leave from work 12 months after initiating treatment. This retrospective study demonstrates that one year after initiating Tysabri treatment, MS patients required 33 percent less sick leave than before they started on the drug. Another study looked at MS patients requiring inpatient hospital stays, and found that Tysabri treated patients exhibited “significant reduction in the percentage of patients with MS related inpatient stays, MS related inpatient costs, and length of stay” (click here).

Most MS patients know that taking Tysabri carries with it the risk of developing a potentially deadly brain infection called PML. Now that Tysabri has been on the market for a considerable amount of time, we have reliable figures as to just what the risks are of developing PML while on the drug. The latest figures indicate that patients who are JC virus negative (JC virus is the pathogen that causes PML) have very little risk of developing the infection, about a 1 in 10,000 chance.

For patients who test positive for the JC virus, two factors come into play in determining their risk of developing PML. The first is whether or not they’ve previously been treated with immunosuppressive drugs, and the second is the amount of time they’ve been on Tysabri. JC virus positive patients who have been treated with prior immunosuppressants have a 1 in 556 chance of developing PML during the first two years of treatment, and a 1 in 89 chance in years two to four.

JC positive patients who have not been treated with prior immunosuppressants need to keep a careful eye on the amount of JC virus antibodies present in their blood, which can now be checked by blood tests. Depending on these levels, the chance of developing PML for these patients in the first year of Tysabri treatment ranges from 1 in 1000 to 1 in 10,000, in years two through four from 1 in 123 to 1 in 3333, and in years four through six from 1 in 118 to 1 in 2500.

The above figures can be viewed nicely in the slideshow below. Click the symbol in the lower right-hand corner of the slideshow to view fullscreen (if that doesn't work, right-click on the symbol and choose "open in new tab"). I’d advise all Tysabri patients to familiarize themselves with these numbers, and make risk/reward calculations based on their individual circumstances, in conjunction with their neurologists. Knowledge is power, people; arm yourselves accordingly.

Barts MSer PML Risk Guide Dec 2013 from Gavin Giovannoni

♦ One of the big problems I have with all of the currently available MS treatments is that they don’t do anything at all to address the root cause of the disease. How can they, since the root cause of MS remains completely unknown? Several recent discoveries may shed some light on that elusive cause, which increasingly appears to be at least partially infectious in nature. In one study, researchers found evidence that a soil-based bacteria, which has rarely if ever previously been found in humans, may be prevalent in MS patients (click here). Researchers reported that “that we identified this bacterium in a human is important enough, but the fact that it is present in MS patients is truly significant because the toxin targets the exact tissues damaged during the acute MS disease process.”

Another study found toxins secreted by bacteria associated with sinus infections in the cerebrospinal fluid of MS patients (click here). This is important because most blood-borne bacteria are blocked from entering the central nervous system by the blood brain barrier, nature’s way of keeping the brain and spinal cord isolated from the nasties that can infect other parts of the body. Infections in the sinuses, though, can circumvent the blood brain barrier by leaking directly from the sinuses into the central nervous system, opening up the possibility that nose to brain transport of bacterial toxins may play a key role in the MS disease process.

Though studies such as these are far from definitive, they do at least attempt to answer THE key question regarding MS: what in heaven’s name causes the freaking disease? There will never be a cure for the MS until that query is answered, and far too little time, effort, and money is currently being spent attempting to unravel this all-important mystery. One would think that such inquiries would be at the forefront of MS research, but instead, because most research is funded by pharmaceutical companies who must turn a profit to survive, the majority of MS research is currently targeted at finding new and better ways to suppress the immune system, resulting in ridiculously expensive drugs that may tame the disease but will never cure it. I’ll practice some self-restraint and stop this line of argument now, before I start ranting and raving and giving myself and my readers a migraine. Arghhh!

♦ Okay, on to one of my favorite subjects, the wonderful world of asinine research. Crack researchers in Germany have determined that spasticity is a problem for MS patients (click here). When I say “crack researchers”, I mean that the researchers must have been smoking crack. How else to explain them wasting time and precious research money conducting a study that confirms what is obvious to anybody suffering from MS spasticity, or anybody observing, even from a distance, somebody suffering from MS spasticity? The researchers could have spared themselves a lot of effort by just asking me or some of my MS buddies about spasticity. Spasticity sucks. End of study.

For those who are blissfully unaware of MS spasticity, the phrase refers to muscles that are rendered stiff and nonfunctional because they receive nerve signals to contract but not the requisite impulses to relax due to the fracked up nature of the MS ridden central nervous system, replete with faulty wiring and short-circuits. Spasticity can afflict almost any muscle in the body, and often causes considerable disability and pain. In fact, many MS patients consider spasticity their most troublesome symptom.

Now, through their earthshaking work, German researchers have, after fastidious and meticulous investigation, determined that “MS patients with spasticity suffer a significant burden because of resulting disabilities and reduced quality of life, especially in cases of severe spasticity”.

HOLD EVERYTHING!!! LIGHT MY PANTS ON FIRE!!! Do they mean to tell me that my twisted and clublike right arm and my clawlike right hand are not doing me any favors, and are in fact a “burden”? That my quality of life might be better if putting on a shirt, sweater, or jacket didn’t require my gimpified body to attempt the moves of a circus contortionist? That the “burden” of my disease would be less if I – gasp – didn’t have any spasticity? And all this time I’ve been gazing upon my twisted and useless appendages with such warmth and affection. Stupid me!

Let me save any researchers currently working on similar studies a lot of sweat and elbow grease. Not only does spasticity decrease quality of life, but weakness and paralysis can also be quite “burdensome”. Yup, arms and legs possessing all of the strength of a fart in a hurricane should not be counted as one of the pleasures of life. Also, bladder and bowel issues are not nearly as much fun as a night at the GiggleSnort Motel. That’s right, contrary to popular belief, urinary frequency and urgency don’t make for a whooping good time. Yes, I’d like to down a couple of pints of icy cold beer as much as the next guy, but I’d better be sitting on a toilet when I do so, because you could calculate the time it takes for the liquid to go from mouth to urethra with a stopwatch. Now, that might be the subject for some fascinating research.

Good grief…

♦ Being “retired” and grappling with a chronic debilitating illness leaves one with plenty of time to contemplate the mysteries of life, wondering just what the hell it’s all about. Gratefully, I came across the following video, in which Father Guido Sarducci (comic Don Novello) explains The Secret of Life. I actually recall the good Father doing this bit on Saturday Night Live back in the late 1970s, when the cast included such greats as John Belushi, Gilda Radnor, and Dan Aykroyd. I remember loving this monologue back then, and the intervening decades have done nothing to diminish its effect on my funny bone. Yup, life is a job, we’re all just here collecting our paychecks, hoping that our balance sheet comes out in the black when all is said and done…


Ciao for now…

Latest MS Drug News; Much of It Bad…

Image by mtsofan via Flickr

There’s been a spate of news in the last two weeks regarding existing and proposed MS drugs, much of it on the negative side. Several drugs have been rejected by the European regulatory agencies, and another has seen the specter of its deadly side effects continue to rise.

Although much maligned by the MS activist community, many of the drugs prescribed for MS have in fact improved the quality of life for many of the patients taking them. Although exorbitantly expensive, not targeted at the root cause of the disease (which remains unknown), and of help to only a portion of the MS population, the approved drugs have been shown to reduce the rate of relapses in some RRMS patients, though there is much question over whether they actually slow the insidious progression of the disease.

The injectable CRAB drugs (Copaxone, Rebif, Avonex, and Betaseron) have been demonstrated in clinical trials to significantly reduce relapse rates in about one third of patients taking them. Copaxone has a relatively mild side effect profile, but the other three compounds, all forms of beta interferon, often make those taking them suffer flulike symptoms for a day or two after dosing. For the patients in whom they work, though, a significant drop in relapse rates can substantially lessen the impact of the disease on their lives. Unfortunately, after over a decade of use, it's still not clear whether or not these drugs have any influence on the progression of disability. A recent report out of Great Britain challenged the notion that the CRAB drugs positively impact progression (click here), but other studies (click here, here, and here) seem to support the claim that these drugs do at least something to slow progression.

A newer generation of MS drugs, including Tysabri, Rituxan, and the recently approved (by the FDA) Gylenia offer a marked uptick in efficacy in both the reduction in relapse rates and MS symptoms, as well as the proportion of the patient population for whom they are beneficial . Unfortunately, along with this increased efficacy comes an increased severity in their potential side effects, which can include deadly brain infections and cancer. These drugs, too, do nothing to address the underlying cause of MS, and work by profoundly altering the workings of the very complex and little understood human immune system, the consequences of which, over the long-term, have yet to be seen. Still, the sometimes dramatic improvements experienced by some patients taking these drugs have led many to be extremely reticent to give them up. In the case of Tysabri, I personally know several patients who, after several years on the drug, have tested positive for the virus that causes PML, a ghastly brain infection, but still refuse to come off Tysabri because of the positive impact it has had on their lives.

Unlike some other MS voices on the Internet, I'm unwilling to label the current crop of MS drugs "snake oil", simply because of the positive influence they do have on the lives of many patients. Certainly, they do nothing to cure the disease, and I do doubt their ability to significantly impact the progression of MS, but I know of enough patients whose lives have remained relatively productive in large part due to these medications that I can't help recognize their value. The actual financial cost of these drugs is mind-boggling, with the price of the newly approved Gylenia (the first oral medication approved for MS) coming in at almost $50,000 per year, and I abhor the fact that MS has been turned into the goose that continues to lay the golden egg for many pharmaceutical companies, but the apparent positive effect of these compounds shouldn't be ignored. Before the introduction of the CRAB drugs, MS was known among physicians as a "diagnose and adios" disease, one with very little that could be done to combat it. The advent of these drugs, no matter how flawed they are, has at least put some arrows in the quiver of those trying to fight MS.

Unfortunately, all of the drugs currently approved for MS have only been shown to work on patients suffering from the relapsing remitting form of the disease; those of us suffering from the progressive forms remain shut out from any even nominally effective treatment. Very few drugs have even been trialed for use on progressive MS patients, but recently at least some attention has been turned to the plight of those suffering from SPMS and PPMS (click here).

Okay, enough of my bloviating about the current state of MS drugs. Here's a rundown of the latest news regarding MS pharmaceuticals. The fact that many of the articles linked to come from financial websites speaks volumes as to the sad state of affairs regarding MS as Big Business:

• Biogen, the makers of Tysabri, released its monthly report on the rate of PML (a devastating brain infection) in patients taking the drug (click here). When first starting Tysabri therapy, patients in the United States are enrolled in what's called the TOUCH program, designed to carefully track them for signs of the infection. The risk of PML infection as a result of Tysabri therapy has long been touted as 1000:1. The statistics released earlier this month show that the infection rate for patients taking Tysabri for less than two years falls well within that figure, but starts to rise dramatically once patients surpass the 24 month mark. The incidence of PML in long-term therapy is now stated at 2.13 per 1000, and the trend suggests that the longer patients are on Tysabri, the higher their risk of infection. After first being introduced in 2005, Tysabri was quickly withdrawn from the market when the threat of PML became known. It was reintroduced in the second half of 2006; therefore, the majority of patients taking it have yet to reach the "danger zone". As I stated previously, many patients are loathe to stop Tysabri after experiencing sometimes dramatic relief from their MS symptoms while on the drug. As the PML count increases, many patients now on Tysabri will have to grapple with some very difficult decisions.
• The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended against the approval of the oral drug Fampyra (click here), which in North America is called Ampyra. Ampyra, approved by the FDA in 2010, is the only drug thus far approved strictly for the symptomatic relief of MS. The compound increases walking speed in approximately 1/3 of the patients who take it. Some patients on Ampyra also report an overall increase in muscle strength. In recommending against the drug, the CHMP said that it "was not convinced that Fampyra’s small effect on the walking speed was a meaningful benefit for patients. The effect on speed could not be linked to meaningful improvements such as better coordination, balance or stamina or increased range of action. The Committee was of the view that the medicine’s uncertain benefits did not outweigh its side effects which included pain, dizziness, paraesthesia (unusual sensations like pins and needles) and problems with balance, as well as symptoms similar to those of multiple sclerosis that could impair the patient’s ability to walk. The Committee also noted the lack of adequate long-term data on the medicine’s benefits and safety as well as data on some groups of patients, such as the elderly and patients with epilepsy or heart problems. The CHMP concluded that the benefits of Fampyra did not outweigh its risks and recommended that it be refused marketing authorisation."
• The CHMP also recommended against the approval of the experimental oral MS medication Cladribine (click here), marketed by the giant drug company Merck. Cladribine has been used in IV form as an anticancer agent since the mid-1990s, with known possible severe side effects. Reformulated in an oral form and named Movectro, the drug went through a full trial regimen for use in RRMS patients, and was shown to reduce the rate of MS relapses and possibly impede the speed of disease progression. In deciding against the drug, the CHMP had concerns about the medicine’s safety. "An increased number of patients with cancer were observed in trials with Movectro, which may indicate an increased risk of cancer over time and with increasing doses. The Committee also noted that the benefits and the most appropriate dosage for treatment had not been fully established in patients who were expected to use the medicine. Therefore, at that point in time, the CHMP was of the opinion that the benefits of Movectro did not outweigh its risks and recommended that it be refused marketing authorisation." The drug will be up for FDA approval later this year, and it will be interesting to see if the FDA follows their European cousins’ decision.
• The CHMP recommended for the approval of the oral MS drug Gylenia, formally known as Fingolimod or FTY 720 (click here). This drug has already won approval from the FDA, and should be hitting the market sometime in the first half of this year. Gylenia is a powerful drug that greatly alters the workings of the human immune system. The compound traps the immune system's T cells in the lymphatic system, thereby keeping them out of not only the central nervous system, but the rest of the body as well. As one neurologist told me, "Tysabri keeps the cops out of a certain neighborhood, but Gylenia keeps them locked in the police station". While many patients relish the thought of giving up their injections or monthly infusions for the simplicity and pain-free action of taking a daily oral tablet, the mechanism of this drug should give pause. Though it has not yet reached the market, it is believed that neurologists will initially be quite careful in prescribing the drug. Interestingly, Gylenia is being tested as a possible neuroprotective agent, so the drug may have a double-barreled effect. It would be wonderful if science could isolate Gylenia's neuroprotective properties and develop a compound that shields nerve cells from the MS disease process, but that development seems far off in the future.

As an MS patient, I find it incredibly frustrating that millions upon millions of dollars are being spent researching, developing, and marketing pharmaceutical compounds that do absolutely nothing to actually cure the disease, but in effect turn patients into indentured servants of Big Pharma. Unfortunately, our medical research model has evolved into a highly dysfunctional beast, one which all too often ignores real patient benefit in favor of the possibility of huge financial gain. The aberrant immune reaction seen in MS is essentially a symptom of an as yet undiscovered disease cause. If even a fraction of the research dollars spent by Big Pharma on drugs designed to suppress or modulate the immune system were instead spent on finding this unknown cause, we might actually be on the road to a cure for this damned disease.

One can only hope that the beliefs of the most fervent CCSVI advocates hold forth, and vascular abnormalities do prove to be a vitally important part of the MS disease process. At the very least, may investigations into CCSVI finally wrench the focus of MS research away from the concept of autoimmunity and onto a model of MS as disease in which an immune system gone awry signifies greater ills still hidden, and at long last brings those hidden ills to light.

Can I get an Amen?

Bits and Pieces: From Sublime to Ridiculous

Image via Wikipedia

Faithful readers of this blog know that I like to regularly share various news items that I find interesting or otherwise tickle my fancy, most of which have at least some peripheral relationship to Multiple Sclerosis. Here's another such collection, along with some commentary. This compilation includes items that range from the extremely serious to the extremely silly, which more or less reflects the real life balance needed to maintain one's sanity. Even though we're dealing with a serious illness, we don't need to be serious about it all the time. In any event, I'll try to put these in some semblance of order, in descending rank from serious to silly…

• "Multiple Sclerosis Will Become a Controlled Disease like AIDS" screams the headline of this article (click here), which talks about some of the breakthroughs that geneticists have made in identifying genes associated with MS. While these discoveries are both encouraging and fascinating, transforming MS into a controlled disease falls far short of the expectations and wishes of those afflicted with the illness. While controlling MS is certainly preferable to just letting the disease run rampant through our brains and spines, it sure would be nice to see the scientific bar raised a bit, to include at least a cursory mention of the possibility of a cure.

  As anybody knows who lived through the scourge of AIDS in the 1980s and 90s, a time when people were being buried at a tragic and distressing rate, the fact that AIDS is now for the most part controllable by means of a cocktail of strong antiviral medications is definitely a huge relief. Certainly, the hunt for a cure for the disease hasn't been abandoned, but you can't help but think that the fact that the disease is now considered controllable has lowered the urgency of that endeavor. I'd hate to see the same situation arise for MS, but in reality, I suppose it already has.

  The advent of disease modifying drugs that do nothing to address the still mysterious root cause of MS, but which have been a tremendous financial boon to the pharmaceutical industry, has almost certainly dampened research efforts to hunt for the genesis of the disease. The fact that these drugs are tremendously expensive and must be taken for the life of the patient has turned MS into a multibillion dollar a year windfall for pharmaceutical companies. Since these companies fund over 70% of the medical research done in this country, and they are public companies whose mission is to constantly increase profits, their money flows towards research that shows the potential for tremendous financial return, which most often takes the form of blockbuster immunosuppressive or immunomodulating drugs.

  Many neurologists have expressed genuine shock over the tremendous emotional embrace given by the MS patient population to the CCSVI hypothesis and the Liberation Procedure used to address it. This surprise on the part of the physicians exposes a serious disconnect between MS Neuros and their patients. MS sufferers innately know that the sometimes extremely toxic drugs they are being given will in no way free them from their disease. They may improve a patient's quality of life by cutting down on MS relapses, but they do nothing to slay the enemy within. Since CCSVI apparently offers at least the hope of a cure, patients have latched onto the theory like shipwreck survivors grasping at life preservers. Regardless of the ultimate outcome of the CCSVI debate, hopefully the patient-doctor dynamic has forever been altered, and even if CCSVI turns out to be less than we now hope it will be, patient driven initiatives will help jumpstart the search for a cure.

• Speaking of disease modifying drugs, the FDA has approved the first oral treatment for RRMS. Developed by the pharmaceutical company Novartis, the drug is called Gilenya, formerly known as Fingolimod or FTY 720. This is the first MS Disease Modifying Drug that doesn't require injections or intravenous infusions (click here for info).

  Hooray, right? No more sticking yourself with needles, or spending several hours a month in an infusion suite, what could be bad about that? Well, unfortunately, potentially quite a bit.

  During trials, Gilenya was found to increase the chances of developing severe, sometimes fatal infections, as well as an increased propensity for melanoma, a deadly skin cancer. In addition, there was some association of the drug with adverse vascular events, macular degeneration, and the possibility of lymphoma.

  On the plus side, Gilenya does dramatically decrease the relapse rates of patients taking it, and also dramatically cuts down on the number of enhancing lesions seen during MRI imaging. There is also some evidence that the drug may be neuroprotective, one of the holy grails of MS research, and for that reason it's currently being trialed on PPMS patients, for whom there are no approved, or even unapproved, treatments. Gilenya may also slow disease progression, another holy grail of MS research.

  I find the mechanism of the drug somewhat troubling, though. Like Tysabri, Gilenya inhibits the ability of immune system T cells to gain entrance to the Central Nervous System, where they significantly contribute to the CNS damage seen in MS patients. While Tysabri accomplishes this by blocking T cells from crossing through the blood brain barrier that separates the Central Nervous System from the rest of the body, Gilenya keeps T cells trapped in the lymphatic system, not only restricting their access the CNS, but to the rest of the body as well. In effect, Tysabri keeps the cops out of one specific neighborhood, but Gilenya keeps them trapped in the police station. Since the compound was only trialed for two years, no one can say for sure what the long-term effects of so profoundly altering our delicately balanced immune systems might be. Sounds like many doctors are going to be cautious about this drug, at least at first (click here for info).

  On an interesting side note, Gilenya is derived from an ancient Chinese herbal remedy called Cordyceps, which is a fungus that grows on the back of caterpillars, and is purported to have many medicinal properties, including those of an aphrodisiac. It's also supposed to increase blood flow and oxygen supplies throughout the body (possible CCSVI implications?) (click here for info). Cordyceps is available through online vitamin and herbal supplement retailers (click here), but I'm not sure what alterations were made to the compound when Novartis synthesized and patented it. Strangely enough, Cordyceps in its raw form is known to increase the activity of the immune system, but some MS patients do report it helps their MS fatigue.

• In yet more drug news, the FDA has approved Nuedexta (click here for info), the first drug designed to combat "emotional incontinence", otherwise known as the pseudo-bulbar affect (click here for info). Some MS and ALS patients suffer from a very strange symptom: the inability to control their emotions, which often leads to inappropriate fits of laughing and crying. I must admit, I do get awfully weepy at some movies, and have even been known to cry at commercials, but these reactions predate the onset of my MS. Throw "Casablanca" in the DVD player, and I'm apt to start crying from beginning to end. What can I say? I'm hopelessly smitten with Ingrid Bergman, and when Humphrey Bogart makes the ultimate sacrifice, letting the love of his life, once lost but then found, fly off with another man in the name of a greater cause, well, pass me the tissues, and they'd better be two ply…

• It appears that a slightly bonkers British chap has eclipsed me as a real Wheelchair Kamikaze. Seems this bloke has attached a gasoline engine to a standard mobility scooter, and reached speeds approaching 70 mph (click here). Hey, my hats off to him, and I heartily applaud his efforts. Wait a second, since he's using a scooter, I guess I can still hold onto my Internet moniker. He's the Scooter Kamikaze. And, in keeping with mobility device kamikaze tradition, he made a pretty cool video of his exploits…

• And in news that has nothing at all to do with MS, it seems that a time traveler has been caught in a 1928 film starring Charlie Chaplin. In the background of a scene in the Chaplin film "The Circus", it appears that a woman walks by apparently talking into a cell phone. Of course, cell phones weren't invented back in 1928, so her actions are quite mysterious. I love the idea of time travel, and if one day I seem to simply disappear, look for me back in 1935, dancing a mean jitterbug at The Savoy Ballroom in Harlem, burning my shoe leather to some big band version of Fats Waller's "This Joint Is Jumping". I'm assuming, of course, that traveling back in time would cure my MS. Anyway, here's a piece from the Chaplin film, showing the alleged time traveler…

Related articles

• From Cicada Fungus To MS Drug: How Big Will Novartis' New Pill Be? (blogs.forbes.com)
• Gilenya priced at $4000/month, 30-50% higher than MS self-injections (brassandivory.org)

MS Study Blatantly Driven by Financial Concerns, Not Patient Welfare

Image by DavidDMuir via Flickr

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

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

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

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

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

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

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

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

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

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

Ugh.

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