(Photo credit: Ancratyne)
(For those readers who receive Wheelchair Kamikaze via email, this post contains a video that cannot be viewed in standard email formats. To view the video (click here) to open the Wheelchair Kamikaze website in your browser.)
Before we get going with this edition of Bits and Pieces, I’d like to thank all of the wonderful folks who left get well wishes in the comments section of my last post (click here) and who sent me emails full of warmth and support. Your words were appreciated profusely, and I only wish I’d been feeling well enough to respond to each message individually. I did read each and every one, though, and they were far better medicine than anything the doctors could ever prescribe.
I’m still on the mend, even after six weeks since I first took Acthar Gel, which precipitated my unraveling. My physicians are still rather confounded at my reaction to the stuff, and my blood work shows that my endocrine system remains in a bit of a tizzy. I’m feeling much better than I did about four weeks ago, but not nearly back to where I was before things went kablooey. Bit by bit, I suppose, and I’m sure my old friend creeping paralysis isn’t helping with the restorative process. As Samuel Goldwyn once said, in this life you’ve got to take the bitter with the sour…
Anyway, enough about me, as I’ve spent the last six weeks or so stuck in bed contemplating little else but my predicament. Far too much time spent gazing inward, and poking and prodding all the monsters that lie within. Figured a Bits and Pieces post would offer a potpourri of distractions to me and all the folks who read WK, so off we go with a collection of items of interest that were able to catch my attention these last several weeks. Hope you find them informative and/or entertaining.
♦ First up, a look at the results of a poll that’s been running on Wheelchair Kamikaze for the last 3 ½ months or so, designed to get a snapshot view of the experiences of patients taking the new oral MS drug Tecfidera. If you are taking Tecfidera and haven’t yet participated in the survey, please feel free to do so now, as the poll is still “live”. The more respondents we get the more accurate the results will be, so please do take the time to answer this brief survey if you are a “Tec-y”:
How would you characterize the side effects you’ve experienced as a result of taking Tecfidera?
Have Tecfidera’s side effects forced you to stop taking the drug?
(This question should only be answered by those who answered "no" to the previous question) How would you characterize any benefits you’ve felt since starting Tecfidera therapy?
In order to view the results of the three poll questions, just click the “show results” link beneath each query.
Before I attempt to analyze the above numbers, please allow me a few words about polling bias and how it might affect these results. I know, you’re all probably thinking, “What a blowhard, what can the Wheelchair Kamikaze possibly know about the intricacies of polling?”. Believe it or not way back in the 1980s I worked for a political research firm that conducted well-publicized polls on a national level. In fact, we were responsible for the numbers reported on the NBC nightly news every evening during the 1988 presidential campaign, which pitted Michael Dukakis against George W. Bush.
I was hardly an executive in the firm, but I did supervise the “phone bank”, where 40 or 50 people dialed phones incessantly for five hours every night, asking the people on the other end of the line their preferences in the presidential race and their opinions on the issues of the day. Chief among my responsibilities was making sure that the people responding to our questions were representative of the population at large in respect to sex, age, race, income, and other demographic criteria. Obviously, a national poll with a disproportionate number of Southerners, or too few women, or too many Hispanics, would skew the results and lead to highly inaccurate conclusions. For any poll large or small to have a chance at being accurate the respondents to that poll must be representative of the target population as a whole.
This same element comes into play when looking at the little Internet Tecfidera poll I’ve been posting on this blog. Since there’s no mechanism to screen those responding, there’s no way to control for an over or under representation of the myriad variables among the folks who comprise the Tecfidera taking population. Furthermore, the simple fact that this is an Internet poll automatically skews the results, as it doesn’t capture the opinions and experiences of Tecfidera users who aren’t surfing the Internet. Of those who are, it’s only representative of the relative handful of patients who have stumbled upon the poll here on Wheelchair Kamikaze and have chosen to participate.
My hunch is that the very nature of a wide-open Internet poll such as this probably skews the results a bit towards the negative, since the many patients taking Tecfidera and experiencing few if any problems are very likely to be simply going about their lives and not bothering to search for Tecfidera info on the web or answering a blog questionnaire on the subject. This phenomena can be seen manifesting itself in the comments sections of the Tecfidera informational posts I’ve put up on WK (click here and here), which are primarily comprised of patients recounting their difficulties experiencing the side effects of the drug.
If one took these comments to be representative of the experiences of all Tecfidera patients, it would be easy to surmise that rather severe side effect reactions were the norm rather than the exception, which clearly isn’t the case. This in no way discounts the validity of the accounts of those commenting on my posts, but simply illustrates the skewed nature of much of the info you’ll come across on Internet MS forums, Facebook pages, and other online communities. Such outlets only provide a window on a subsection of the MS population, and all information and opinions gleaned from such sources, both positive and negative, needs to be viewed in that light.
Now, having said all that, I find the results of my little Internet survey to be quite interesting, especially when a bit of negative bias is taken into account. As of this writing, 557 patients had participated in the poll. Let’s have a look at the numbers.
The first question asked is, “How would you characterize the side effects you’ve experienced as a result of taking Tecfidera?” Fully 61% of those responding report experiencing few if any side effects (answering “none” or “mild”), while 23% of respondents report dealing with moderate side effects, and 14% characterize their side effects as severe.
That 14% of folks taking Tecfidera report experiencing severe side effects is concerning (representing approximately 1 in 7 patients), but, as I stated previously, I suspect these results are skewed somewhat towards the negative. Even so, the number does seem high, and is certainly higher than I expected when I first set up the poll. Still, the terminology involved is a bit subjective, in that people have different tolerances for the discomfort caused by side effects, and what one person terms “severe”, another might term “moderate”.
I think the next question demonstrates this subjectivity to an extent. When asked, “Have Tecfidera’s side effects forced you to stop taking the drug?”, 88% of those answering say no, and 11% report that they have indeed stopped taking Tecfidera due to the drug’s side effects. Since 14% reported severe side effects in the first question, it’s apparent that about 3% of those folks didn’t find their side effects to be severe enough to make them stop taking Tecfidera. This question doesn’t touch on a key element in determining whether or not a patient continues on with a drug, namely the length of time that side effects persist. It’s generally been reported that Tecfidera side effects dissipate after 6-8 weeks, so the possibility exists that some folks experiencing severe side effects might be able to stick out their discomfort long enough for those side effects to no longer be a problem.
Interestingly, the two major late stage trials of Tecfidera reported that only 2% of patients taking the drug had to stop due to intolerable side effects, the same number as those who were taking a placebo. Certainly, these trials were far larger and much more controlled than my rinky-dink little Internet survey, but the disparity in results is curious. While much of this difference can probably be attributed to the negative bias inherent in my Internet poll, it’s been reported that drug companies routinely fail to report on the results of people who drop out of their studies, a practice which, if true, is at best abhorrent. It’s been widely demonstrated that drug companies consistently suppress research results that don’t reflect positively on their products, publishing only favorable study results (a phenomenon called “publication bias”), so such charges wouldn’t surprise me. As I’ve stated time and time again, the mechanisms by which medical research is conducted and reported these days are almost completely dysfunctional, much to the detriment of patients and the doctors who treat them.
But I digress, as I can easily work myself up into a frenzy over pharmaceutical company monkeyshines. Before I start frothing at the mouth, let’s get back to looking at the results of my Tecfidera survey. The last question asked is probably the one that patients would ultimately deem to be the most important, “How would you characterize any benefits you’ve felt since starting Tecfidera therapy?”. After all, Tecfidera’s ability to control MS symptoms is the ultimate arbiter of its worth to patients.
Before delving into the numbers, it’s important to remember that I first posted this survey only a few months after Tecfidera was approved by the FDA, and it’s been shown that it takes about three or four months for the drug to fully take effect. Though I’ve no way of knowing this precisely, I’m sure many of those responding to the poll had not been on the drug long enough for it to reach peak effectiveness. Given that fact, I think the results conveyed are fairly impressive. Nearly 50% of respondents (46%, actually) reported experiencing some benefit from the drug, and 21% deemed those benefits to be “moderate” or “great”.
Since many of those responding did so within their first few months of taking Tecfidera, the fact that nearly half had already experienced some benefit is encouraging. Tecfidera affects the body on a number of levels: as an immunosuppressant, an anti-inflammatory agent, and as a potentially powerful antioxidant. Given this variety of mechanisms, one would think that the benefits of Tecfidera might increase with time, and indeed this is what the published research on Tecfidera has shown. It would be very interesting to conduct a poll that queried only folks who had been on Tecfidera for five months or longer, but given the vagaries of the Internet there’d really be no way to accurately capture such a population, at least not with the relatively simple tools currently at my disposal.
So, there you have it, my attempt at playing master researcher, and reliving my youthful sojourn into the world of quantitative research, when Dukakis battled the senior Bush for the Presidency of the United States (it really didn't turn out to be much of a battle, actually). I hope these survey results, and my analysis of them, are helpful to folks currently taking, or who are considering taking, this increasingly popular new drug.
♦ Wow, going over the Tecfidera poll results took a lot longer than I was expecting, so I guess rather than this post being a “Bits and Pieces”, it’s going to be more of “A Bit and A Piece”. I blame the length of the poll results section on the fact that I use voice recognition software to “write” my posts, which makes it far too easy to turn verbal diarrhea into written diarrhea. My apologies.
This last item, though, is quite important. The following video was produced by the Myelin Repair Foundation, one of my favorite MS research nonprofits. It features the family members of my buddy George, known on the Internet as The Greek From Detroit, who passed away last March (click here). The video recounts his struggle with MS, and the impact it had on him and all of those around him, while also telling the story of the MRF and the incredibly important work the organization is doing.
Please watch the video, which is both extraordinarily touching and very informative. The research being done by the Myelin Repair Foundation represents one of our best chances at finding a way to repair the nervous system damage done by multiple sclerosis, and their efforts deserve the support of all MS patients and the people who love them.
And to my friend The Greek, I miss you, pal…
Thanks again for all of the get well wishes, they were appreciated beyond words…
I hope you continue to recover. Thanks for the video.ReplyDelete
Your posts are so vital to the MS community.
Thank you for your eloquence, research and strength.
And for showing this video, again, we thank you because the MRF has a real focus and determination to help MS recovery.
And, thanks to the MRF for creating, marketing and showing this video to make MS real to its research community and conference.
Healing to you.
I've only been on Tecfidera for a couple of months, so maybe it's too soon to notice specific benefits. The main one I noticed on Tysabri (which I couldn't take indefinitely because I have JC virus antibodies) was much better heat tolerance, so maybe there's something equally unheralded lurking with this drug. (I was in NYC at the time, and it meant a NYC summer was tolerable.)ReplyDelete
Marc, thanks for all of your hard work, insights, great writing (ok speaking) skills and most of all your attitude which is inspiring more people than you will ever know. My wife has MS ---mild compared to others and has just started Tecfidera after 16 years on Betaseron and these first 3 months have been great for her. Thanks again for... keeping on keeping on.ReplyDelete
I've been on tec for 2 months and I can already tell its been doing its job. Obviously, no flare ups. And my stamina has improved and walking more in a straight line instead of weaving. LolReplyDelete
Glad to hear from you, Marc. I have been on Tecfidera for 3 months and I love it ... mild side effects and less fatigue. Thank you for sharing the video. The fact that George only had the support of his immediate family after a while made me so sad. You have Karen and I have my wonderful husband ... I ache for people who don't have that kind of support.ReplyDelete
Marc glad your doing better you know I've been listening and watching since our early you tube days you used to video alot we used to discuss this crazy thing called Ms...I was born with Ms...you were amazed...well I'm not running anymore but rolling 5yrs to be exact. .been on everything med wise Tecfidera now for 6mnths best drug for me drs are building me a robotic rewalk suit it starts Dec2nd ., I refuse to not fight Multiple Sclerosis! ;)..,Godbless you.ReplyDelete
ive been part of the trial since 2009 extended study since 2011...now I can work in education couldn't even dream of doing that before and no relapses for those years...in fact improvements...walk further faster and balance so much better..can get on my push bike & go for a ride mow my lawn for half and hour straight without collapsing with the fatigue walk around supermarket sometimes carrying heavy basket of groceries (5kg maybe) without having to stop and sit down or even stumble...ReplyDelete
my name is Tessy i was suffering from hiv/aids my pcv which is my blood level was very high, i was worried about my cd4count and viral load.. i heard about the power of Dr Oko healing medicine i apply for it and the doctor gave me the medicine and spiritual healing prayers to say and told me that the power of the healing drugs can cure my hiv/aids and he also told me to for get about the pcv, cd4 and viral load.. i really used the medicine and i was cure from hiv/aids i urge you all to get the DR OKO healing medicine, you reach the great man that produce the healing medicine through his email address at: email@example.comReplyDelete
Thanks for introducing me to George. What a great video. Like him, I have lost most of my friends and my brothers. The only ones who have stayed with me are my husband and two friends. Fortunately, the MS Community is loving and strong. Thank you for your intelligent and inspiring blog, WK.ReplyDelete
Thanks again Marc for your words and all of your efforts in keeping dialogue and information coming out.ReplyDelete
I've been on Tecfidera since early July. I felt a slight perk up for about 2 weeks immediately after taking it (but that could've been just a blip). Since then, I've regressed back to feeling as if I am in some sort of a chronic flare since that started at least since last Spring. I have limited amounts of time where I feel a lift from the onslaught of symptoms like achiness, tight muscles, chronic pain, weakness, debilitating fatigue and the myriad of other MSey stuff. Oddly enough (even though my spinal tap showed 9 o-bands and elevated proteins), my MRI's have typically been pretty unremarkable and there is no change and no new lesions. So I feel worse, yet my MRI shows nothing new. My husband and I were wondering if the drug is actually hindering rather than helping or if it's just not effecting anything for me at all and MS (or whatever) is just doing it's thing. I am going to continue the drug to see how things go for a few more months. The Tecfidera side effects are minor. I will flush at times (sometimes hours after taking it and after eating) and get nauseous still, but nothing I consider a deal breaker.
Thanks so much for what you do.
Glad you are on the mend! Thanks for the blog - it is the best info on Tecfidera I've found!ReplyDelete
I initially answered the poll in Mid-October -- because I was having problems and searching out info. I quit on Day 12 I think, and that is probably when I answered the poll. I am back on the drug now though, and have been for about a month. I am only taking one 120 mg pill per day. Tomorrow I will start 2 120 mg per day. My doc decided that I should be on a very low dose as opposed to nothing and didn't want me switching around since I did want to give Tec a try again when I felt I could miss more work and handle the side effects. (I have been teaching ad junct this semester in addition to working full time with three kids - and in October, I was both teaching and making a Halloween costume - I had NO time to be sick then - its nice to choose when you are sick, isn't it?) Anyway, I will do the 2 120s a day for the next month and then go to a 120 and a 240, then the full dose in February.
On the 120 per day, I did still experience stomach issues the first week or two. I really don't notice any now. I still get very severe flushing sometimes though. Taking the pill with fat makes a huge difference - as in NO flushing at all. I never eat fried food much but once I took it with fried chicken (this was just the third or fourth day back on it) and I had NO reaction. I just learned that all the t-giving food (which should have been pretty high fat) didn't stop the flushing unless I ate a few bites of ham as opposed to turkey. Yesterday, I ate a slice of pizza and salad and had NO reaction. I can eat a cup of tomato bisque and salad with just a little cheese and egg, and that is enough fat to buffer it. I'm trying to figure out how much is enough so I don't gain weight.
Here's another interesting discovery though -- jalepenos will bring on a crazy flush. So, no matter what I take the pill with, something hot later on in the day will bring on the flush.
What is the flush exactly? For me, my head starts itching, and then my face, neck, it moves down. and I turn very very red - like a lobster and very very hot. A bad one will go all the way down my body. A mild one might just be some itching around the neck and face, and then it's gone. It doesn't last beyond 30 minutes though even if it's a bad one. It can be embarrassing if it happens in public but otherwise I think it's not enough to stop me taking the drug. And I kind of know how to keep it in check now with the fat intake.
As for benefits, I really don't have many MS symptoms typically and have only had one relapse since onset in 2001. I have very cold feet all the time (they are not in fact cold - just feel cold to me), and I have some issues in the Summer with heat. I have some swallowing issues but not sure that is MS or just acid reflux issues (the drug I take for that can cause a feeling of tightness in the throat). So, I am doing well, which is the status quo for me.
I write all this in hopes it might help someone who is taking Tec or thinking about it -- in case you have really bad side effects initially (like the stabbing stomach pains I had), know you can move to a slower titration and probably do better -- although that remains to be seen in my case because it will be two more months before I start full dose.
Thank you for all of your research and postings. I always look forward to reading your posts.ReplyDelete
I am 56 years old,Relapse/remitting, diagnosed in 2011 . I also am a type 2 diabetic. I tried Tecfidera for 4 days. I could endure the upset stomach, and the hot skin flushing, but had to stop taking Tecfidera when I started getting blurry vision and mild headaches. I feared swelling behind my right retina...the same thing that made me stop taking Gilenya . Any suggestions on what the best MS Drug to take with the least amount of bad side effects?
Thanks, Marc. My profile is a lot like yours - 54, male, from NY, diagnosed in 2003, apparently PPMS (never a relapse) but some people suspect Lyme or who knows what. I'm still walking, but with a cane, and progressing rapidly. I've tried Copaxone, Gilenya, and Tysabri (despite being JC positive and briefly using an immunosuppressant a while back), and nothing has worked. This morning, I will start Tecfidera.ReplyDelete
Your site is fantastic - smart, unflinchingly honest, serious, funny, ironic, well written, and well researched. I hope doing it has helped you, because it is definitely helping me and many others. I watched the George Bakos video and I wept.
I wish you, and me, and everyone dealing with this scourge heath and hope.
Hi Marc and Readers...I have been quietly visiting your site and absorbing information I had no idea I would need to deal with in my new reality just two months ago. After a hard fall at my age of 64, a mild concussion persisted to be bothersome, and after two weeks of returning to an Urgent Care, I was sent to the emergency room. The CT scan showed questionable lesions that led to two MRI's, first of the head and then of the neck. The up side to the down side was/ is MS as opposed to metastatic tumors. I may well have had it for over ten years. The fall triggered tingling in my hands. I used to get dizzy at the change of temperatures as the seasons rolled and for years attributed it to vertigo. I am now in my second week of Tecfidera. Thank you all for sharing your experiences. I don't eat meat or dairy now, and have adjusted somewhat well since we have been healthy eaters. I have scoured the Internet and adopted a three meal plan that works. I am less lightheaded, less dizzy, but feel a weakness I did not know before the fall. My eyes feel tired and scratchy....I wanted to reach out to you because there are times when I have felt incredibly alone, embarrassed to keep focusing on me, and wondering how others fare. It felt frightening at first...to read what I was afraid I might learn, but now I see by the conversations, the remarkable photographs, and heartfelt sharing, life goes on. I want to thank you. May God bless each of you with smiles and peace each day. This is a lovely community....(I'm a dinosaur with computers...I have no idea what I clicked to get an open id, sorry)ReplyDelete
Hi, so sorry to hear of your diagnosis, but it does sound like you're doing all the right things including starting treatment early. Glad that you found some useful info and support here, and thanks for the kind words about my blog.Delete
For more info and access to other people with MS, there are many other interactive Internet forums that act as active MS communities. May I recommend MSworld.org, one of the largest of these sites, which has many different forums ranging from general interest to individual medications to healthy lifestyle advice. It's a great place to "meet" other people going through the MS experience, for both learning and support.
Wishing you the best…