Here in NYC, we’ve been subjected twice (so far) to a meteorological horror called the Polar Vortex, a huge mass of frigid air that descends from the North Pole, bringing with it plunging temperatures and loads of snow. In my previous 49 winters I don’t recall ever hearing anything about a Polar Vortex, though I do remember plenty of times freezing my ass off, so perhaps this is just a new name for an old song. Whatever the case, getting around in a wheelchair in temperatures fit for the Arctic can be brutal. Not that walking around when the wind chill hits instant frostbite territory is any great shakes, but at least the very act of walking generates body heat. Sitting in a wheelchair does no such thing, and the breeze added by zipping around at 7 or 8 mph only adds to the freeze.
Fortunately, I’ve got some very good cold-weather gear. Never mind high-tech fleece and modern materials like Thinsulate, my warmest piece of kit is an exact replica of the shearling jackets worn by US airmen fighting high in the skies above Europe during World War II. Back then the interiors of military aircraft were unheated, and at 20,000 feet the temperatures were routinely well below 0°F. My B-6 flight jacket is so warm that I can’t wear it in temperatures much above 25°F, and even when the temperatures hit the single digits a T-shirt and a thin wool sweater worn under the jacket are more than enough to keep me toasty. I also have a replica of the shearling hat worn by World War II flight crews, so decked out in my vintage military gear I can zip around the frozen city making believe my wheelchair is a P-51 Mustang fighter plane engaged in fierce dogfights with the mighty Luftwaffe (represented by oblivious pedestrians staring at their cell phone screens despite the freezy conditions) on the streets of New York. I’m proud to say this winter I’ve achieved the lofty status of “ace”, having bagged far more than the requisite five kills. Mwah hah hah.
Unfortunately, donning the flight jacket requires wrestling with my arch nemesis, the zipper. The freaking things are almost impossible to use when you’re down to only one marginally good hand, so I have to allot myself an extra 10 or 15 minutes of prep time just to get my goddamned coat on. Have I ever mentioned that having MS sucks? (I’ll be presenting some exciting zipper related news later in this post, I hope you can bear the suspense.) Luckily, for temperatures just a bit below freezing I have a very special pea coat that my mother-in-law, who is quite the whiz with a sewing machine, made into a Velcro fastened wonder. She removed the buttons and then sewed them on top of the coat’s now sealed buttonholes, affixing Velcro fasteners to the garment where the buttons would normally hold the coat closed. The black Velcro patches exactly match the color of the coat, making them almost invisible, and when I put it on the coat practically “buttons” itself. The buttons sewed over the buttonholes give the illusion that the coat is fastened in the customary fashion, giving no hint of the Velcro customization within. I made sure to get a military issue pea coat, so the thing is quite warm and sharp looking to boot. I’m pretty sure I have the only Velcro fastened pea coat in existence, and I’m positively tickled with my piece of unique outerwear. It’s like haute couture for gimps.
So, between my World War II flight jacket and my MS friendly Navy pea coat, I’ve got the problem of winter wheelchair attire practically licked. I’m sure this comes as a great relief to all of you, so rest easy, the Wheelchair Kamikaze will not be found frozen stiff in his chair on the thoroughfares of New York anytime soon. And the Luftwaffe will not be menacing the sidewalks of NYC, at least not on my watch. After all, terrorizing the streets of New York is my job.
But enough about me, there’s been a lot of interesting MS and disability related news lately, so forthwith comes my semi regular compendium of noteworthy tidbits… Onward, doggies, mush mush…
♦ There’s no denying that in addition to being a horrible disease, multiple sclerosis is also a burgeoning multibillion-dollar a year industry, with many of the drugs developed to combat the disease attaining “blockbuster” status. Ever wonder just how much money MS drugs bring in? Well, wonder no more, because here’s a list of the top 10 selling MS drugs of 2013, along with the cash flow generated by each (in American dollars):
#1: Copaxone-$4.3 billion
#2: Avonex-$3.0 billion
#3: Gilenya-$1.9 billion
#4: Tysabri-$1.7 billion
#5: Betaseron-$1.1 billion
#6: Tecfidera-$876 million
#7: Rebif-$622 million
#8: Ampyra-$302 million
#9: Aubagio-$226 million
#10: Extavia-$159 million
Add up all of that mazuma, and the top 10 selling MS drugs generated sales of roughly $14,000,000,000 last year. Yup, that’s a lot of zeros. Keep in mind, the sales of Tecfidera only represent about one quarter of the year, since the drug was first approved midyear and didn’t reach patients in large quantity until the fall of 2013. Additionally, Tecfidera was only recently approved for use in Europe (click here), so expect sales of the drug in 2014 to approach at least four or five billion dollars. Factor in all of the money made by MS neurologists, MRI facilities, infusion suites, medical laboratories and other MS related services and facilities, and it's easy to see that multiple sclerosis has become quite the cash cow. I don't know about you, but the idea of "disease as industry" makes me a little bit queasy. For more info on each of the above drugs (click here).
♦ Speaking of blockbuster MS drugs, the Israeli pharmaceutical company Teva has received FDA approval for a higher dose Copaxone regimen requiring injections only three times a week (click here), as opposed to the daily injections patients currently on Copaxone must undergo. Copaxone was among the first of the disease modifying therapies to be marketed for MS, and was first approved in 1996. Since then, the drug has been shown in several studies to effectively reduce relapse rates and enhancing lesions for those RRMS patients on whom it is effective by about 35%. Recent open label studies looking at the long-term effects of the drug indicate that Copaxone may also positively impact the rate of disease progression (click here).
One may wonder why it took Teva 18 years to seek approval for a thrice a week version of the drug, since the new dosing schedule is obviously much more appealing than the old daily injection regimen. Maybe I’m a jaded cynic, but the fact that several companies are preparing to introduce generic Copaxone on the market might just have a little something to do with it. All of the generic versions of Copaxone are undergoing trials as once daily injections, so by getting approval of the three injections a week dosing regimen, Teva has made good old-fashioned brand-name Copaxone a much more appealing option from the patient perspective. Additionally, the success of Tecfidera, an oral medication, may also have played a role in Teva seeking a way to make the administration of Copaxone a less painful proposition. As was illustrated in the above list of top grossing MS drugs, Teva has about four billion reasons to try to protect their Copaxone franchise. In any event, this is good news for patients who have had success with Copaxone, who will now be required to give themselves 60% fewer injections. Of course, if there are any Copaxone patients out there who are masochists, this could be bad news, but hey, you can't please everybody…
♦ As I reported in my last Bits and Pieces post (click here), the powerful experimental MS drug Lemtrada was recently denied approval in the US by the FDA. The drug has been approved in most of the rest of the world, including, most recently, Mexico (click here). This action by the FDA has raised the ire of US MS patients, researchers, and clinicians alike (click here and here).
The FDA claims that it did not approve Lemtrada because the trials undertaken to prove the drug’s efficacy were poorly designed, but the FDA had previously approved the design of those very same trials. Lemtrada is a very controversial drug, as it carries a very high risk/reward profile. In trials undertaken by the drug’s manufacturer, Genzyme, as many as 50% of patients with highly active RRMS given Lemtrada were shown to have no evidence of disease activity (no relapses or new lesions) five years after they received their last dose of the drug. This is a startling success rate, but it comes at a price, as up to 30% of Lemtrada treated patients develop autoimmune thyroid diseases, and some develop a potentially fatal autoimmune blood disorder. It’s important to note that autoimmune thyroid disease is easily treated using hormone supplements, and the risk of the autoimmune blood disorder can be at least in part alleviated through careful monitoring.
Lemtrada is a powerful immunosuppressive agent which works by essentially rebooting a patient’s immune system. For patients with highly aggressive relapsing remitting disease, suffering some of the worst ravages of MS, the potential benefits of the drug could very well outweigh the known risks. I personally spoke to an MS neurologist who has my utmost respect about the FDA’s decision, and he was extremely dismayed by the agency’s actions, telling me of one patient who was being laid to waste by one of the most aggressive forms of relapsing MS. Not only did the drug stop the disease in its tracks, but the formerly MS ravaged patient recovered enough to actually be able to go back to work. Given this level of potential benefit, shouldn’t the decision as to whether or not to use Lemtrada be left in the hands of neurologists and the patients they treat? Seems the rest of the world thinks so, but not the FDA. Nope.
♦ In a disconcerting piece of MS news, a recent study has found that MS does indeed negatively affect life expectancy in the patients it strikes (click here). Researchers used insurance claims to identify a group of over 30,000 MS patients, and compared them to about 90,000 non-MS patients, finding that the MS patient population lived on an average six years less than their non-MS counterparts. The results of this study mirrored those done in some other parts of the world, but this was the first time such data was examined for MS patients in the United States. It’s important to note that this study looked at patient data from 1996-2009, and thus doesn’t include patients taking some of the newer, more powerful MS drugs. One can only hope that these drugs will positively affect MS patient longevity, and that future treatments will have an even greater significant positive impact. One can also hope that researchers concentrating on areas other than immunosuppression will come up with drastically more effective treatments that – gasp – actually address the root cause of the disease. Fingers crossed.
♦ In some better news, researchers in Australia have had initial success treating a patient with secondary progressive MS by increasing his immune response to Epstein-Barr virus (click here). EBV has long been suspected to play a role in the MS disease process, and this is the first research to directly target the virus in an attempt to alleviate multiple sclerosis. The research involved isolating a specific type of immune system cells, called “killer T cells”, from the patient’s blood, adding an experimental anti-EBV vaccine to them, and then growing more of them in the laboratory. The cells were then injected back into the patient over the course of eight weeks. The patient reported less fatigue, fewer leg spasms, better cognition, and improved use of his limbs. Of course, this was only one patient, and this research is in its very earliest stages. But hey, hope springs eternal…
♦ More news on the “infectious” front. Researchers following up on the discovery of a rare foodborne bacteria in an MS patient (click here) have infected rodents with that same bacteria, and found that the little varmints developed a disease very much like MS (click here). It’s long been suspected that infectious agents play some role in the MS disease process, a belief based on a convincing body of evidence. In fact, before attention shifted to the “autoimmune hypothesis” and pharmaceutical companies started making billions of dollars by producing drugs that tinker with the MS immune system, much if not most MS research was directed at finding the presumed infectious cause of MS. This area of research has been widely neglected for the past couple of decades, though, but interest in it seems to be picking up. From a patient perspective, this is a very good thing, for if one or more infectious cause or causes of MS can be positively identified we would finally be making great strides towards curing the disease. So, let’s pick up our MS research cheerleader pom-poms and shout in unison: “Frika Fraka, Firecracker, Shish Boom Bah, Infectious Agents, Infectious Agents, Rah Rah Rah!” Unfortunately, because of my debilitated physical state, I’m only able to pick up one of my MS research cheerleader pom-poms, but I expect the rest of you who are more able-bodied to do some vigorous two-fisted cheering.
♦ Although the above rhyme is about as poetic as I get, another member of the MS blogger community, Judith Mercado, is a far more accomplished poet, and has now published a book of her inspired work. Author of the blog “Peace Be with You” (click here), Judith writes her poetry in the ancient Japanese form of haiku, and I’ve long been a fan of her work. I was greatly honored when Judy asked me to provide a blurb for the back cover of her upcoming book, Peace on the Journey, and was of course happy to do so. If I may take the liberty of quoting myself, Judy’s “words resonate with wisdom and truth, and grace the reader with intimacy, honesty, and understanding.” While Judith’s blog often references her MS, the poems in Peace on the Journey are meant for a more general audience, anybody who travels on the sometimes gentle but all too often tumultuous path of life. Peace on the Journey is available in paperback and electronic Kindle version on Amazon (click here). Highly recommended.
♦ As promised, here is the earth shattering zipper news I promised the opening paragraphs of this post. An inventor seeking to help his physically challenged uncle has come up with “Possibly the Most Radical Innovation to Zippers in over a Century” (click here). Eventually joined by his mom and a mechanical engineer neighbor, inventor Scott Peters spent six years and went through over 100 prototypes before coming up with the Quickzip, a magnetically assisted zipper that only requires one hand to fasten. Be still my heart! The team of the inventors struck a deal with athletic clothing manufacturer Under Armour, which plans to start marketing Quickzip (now renamed Magzip) equipped clothing in the fall of 2014. I’m not one to encourage patent infringement, but I call on clothing manufacturers worldwide to meet this challenge and come up with their own easy fastening zipper innovations. Must I pick up my cheerleader pom-pom once again?
Here’s a rather, um, dramatic video produced by Under Armour highlighting the new technology…
As usual, Marc, a well researched and comprehensive review of the state of most things MS, that is, in the realm of MS drugs. I can't believe that you actually drive your chair out in the cold NYC Winter, but your coats sound awesome. What to you use to keep your legs warm?? It seems that a pair of long johns wouldn't cut the cold coming at you at 8 MPH. I assume you are also wearing a ski mask and goggles!? You're braver than I am, that's for sure, and my chair hasn't yet arrived.ReplyDelete
Well, truth be told, I try to keep my wheelchair excursions fairly short in the freezing weather, so longjohns are more than up to the job. Ever since I got sick I've been far less sensitive to the cold then I was in my younger days, and I prefer the cold of winter to the heat of summer, which positively makes me wilt.Delete
Seems that you've been waiting for your chair for quite a while. I know how that is, though, as trying to deal with insurance companies and equipment vendors can be a huge headache. Hoping you get your chariot soon…
Marc, it is I who is honored. Thank you so much for mentioning my book. Thanks also for your wisdom as you help us navigate the MS experience.ReplyDelete
Judy, thank you. Guess we have a little mutual admiration society going. Best of luck with your book…Delete
I really want that zipper, in spite of the dramatic video :).ReplyDelete
Me too! Can't even begin to express how much easier that zipper will make my life…Delete
Your bomber jacket sounds like my heavy Irish sweaters. I can understand why fisherman could brave the damp and cold wearing one. I love the zipper -- I wish it wasn't owned by just one company.ReplyDelete
Yeah, my bomber jacket is kind of like the comfort food of clothing. I'm also a little ticked that the innovative zipper has been monopolized by one company, but I'm sure if the feature proves popular, other companies will find ways to emulate it.Delete
Marc, I recommend adding "kill marks" to your new chair for each pedestrian you strike. Will make you more menacing and may inspire prudent avoidance on the streets of Manhattan. At least when folks actually look up from their phones.ReplyDelete
Dave, love the idea about "kill marks". I'm visualizing each being a little stick figure with a broken shin. As for folks actually looking up from their phones, I think that may just be a lost cause at this point… Why look around and take in the sights and sounds provided by one of the most fascinating cities in the world when you can concentrate all of your mental capacities on a 3 inch screen? I'll never understand it.Delete
So now they're making automobile in dash video/navigation systems compatible with smart phone technology. Imagine playing your favorite video games while cruising 70 mph down the highway... Brilliant !!!Delete
That is some video all right. Favorite line: "My god, he's going to give us a hard time about those stinking zippers again?"ReplyDelete
just great....and it wouldn't be the first time equipment, training or rehab for athletes benefited us gimps.
I just hope the magnets prove to hold well.
Also, thanks for the great breakdown on MS drugs. Stay warm!
I'm sure that "stinking zippers" guy must be a real charm to work for. I've been unfortunate enough to work for a couple of corporations that transformed the CEO into the center of a cult of personality, and let me tell you, those guys can be real pricks. Then again, maybe that's what it takes to be successful these days. If true, that's a condemnation of these days.Delete
I really enjoyed reading this latest blog post of yours. I feel for you on the winter front (I'm just outside of Philadelphia), and as an avid lover of snow, I'm tired of it already. Enough is enough.ReplyDelete
The info about Lemtrada is always enjoyable, as is the news from Australia. Thanks for keeping me informed.
Hey Jonathan, looks like we are in for more snow this weekend. Great, right? The winter that wouldn't die…Delete
As for Lemtrada, I'm of two minds about most MS drugs, but I certainly think that the decision as to whether to use a drug that has proven to be potentially beneficial should be one made by patients and their doctors, as long as the drug doesn't represent major risk to life. Lemtrada certainly has its downsides, but then again, so does MS.
Ampyra - $302million An interesting figure.ReplyDelete
As far as I am aware the potassium channel blocking abilities of 4 Amino Pyridine (active ingredient in Ampyra?) is the only useful medication for my SPMS. However at $600pm the commercial medicine is unaffordable.
Enter compounding pharma. In Australia a local pharmacist make me slow release 4AP for $50pm
It does (as proven to me by stopping and restarting) make a huge difference. Would you consider a post about 4AP?
I spoke to my neurologist yesterday about Ampyra. He said it was less than wonderful. He has 5-6 patients that are currently on it, all of whom are very unsteady on their feet. The patients swear they can tell when they miss a dose, but the doctor himself can't tell a difference outside of piece of mind.Delete
Aside from that, he's not a big fan of the company himself. It seems that the medication has been around for a LONG time, but the company in question realized that it was used a lot in the MS field, so they decided to remarket it as an MS medication, and decided to substantially up their price range in the process. Not unlike HP Acthar Gel.
So yeah, there you have it (from my Neurologist). Enjoy.
David-I wrote a few posts about Ampyra/4-AP back when Ampyra was first getting its FDA approval. If you search for Ampyra in the search box in the upper left corner of the blog you should find a handful of posts on the subject. BTW, did you know that 4-AP has been used commercially for years as bird poison? Yup, fries their feathery little nervous systems…Delete
Jonathan-the Ampyra trial results were less than impressive back when Acorda was getting the drug approved. If I remember correctly, about 30% of trial subjects had their walking speed increased by about 30%. So, not earth shattering, but I suppose for those patients on which it works, it's better than nothing… As David points out, it's possible to get pretty much the same stuff from a compounding pharmacy for much less than the cost of Ampyra…
good read thanks those jackets are pricy! i am always cold. you are always so informative thank you :)ReplyDelete
Hi Camille, yes, the bomber jacket is pricey, but I looked at it as a long-term investment. The thing is quite rugged, and will probably last longer than I do…Delete
Thanks for your kind words about the blog…
I know I might be in the minority, but I think the 6 year reduction in life expectancy is a good thing. All of the numbers I have seen before this post had it between 7 and 9 years shorter.ReplyDelete
Not to be morbid, but that relatively slight reduction in life expectancy applies primarily to RRMS patients. I believe that if the study concentrated on folks with progressive MS, the drop in life expectancy would be much more substantial. Don't want to scare anybody, but progressive MS can be a terror…Delete
I am a boring person who talks about the weather all the time but seems to affect my life lately. I did not know all those drugs were that much money. I know progressive is a terror, hope they can get some meds for it soonReplyDelete
Hi Marc, I've been trying to reach you through a few different avenues ... I work with Sermo.com and would love to speak to you about thanking doctors. Sorry for leaving this as a comment on your blog. But if you're up for it, I'm Lisa.Johnson [@] Sermo [dot] com ... also did the music scene in Boston in the 80s btw, wonder if you ever hung out at the Rat or TTs? :-)ReplyDelete