It’s time once again for another edition of “Bits and Pieces”, a regular feature of this blog in which I present mostly MS related items that have found their way into my knapsack as I rummage around the Internet. But first, I’m going to try something brand spanking new. Drumroll please…
Okay, brace yourselves for the first ever Wheelchair Kamikaze interactive poll, where readers can register their responses to a few questions, and we can all view the results as they roll in. Creating this rather simple poll was much easier said than done, as the blog platform that I’m using doesn’t provide a handy a way to embed polls in blog posts, but with the help of the Google gods I figured it out (I hope).
The poll attempts to investigate the experiences of Tecfidera users, so, naturally, active participation in the poll is limited to those who have used or are currently using the new MS pill. I expect the results should be interesting for everybody with MS. A few months ago I put up a couple of blog posts summarizing some of the research I did on Tecfidera (click here and here), and the posts have received an incredible number of hits (over 30,000 and over 13,000, respectively), so I figure interest in the subject is high. I’m as curious as anybody to get a snapshot view of the Tecfidera patient experience.
Of course, the results of following poll will be completely unscientific, and are subject to the general whims and vagaries of the inter-webs. So, whatever the results, please take them for what they are, an amateurish attempt at patient pulse taking, hopefully interesting but far from definitive.
So, without any further fanfare, here’s the first ever Wheelchair Kamikaze reader poll. In the interest of trying to maintain some semblance of accuracy, please only answer the poll questions if you have actually taken Tecfidera, and if you are a Tecfidera user, please answer each question only once. No stuffing the ballot box, so to speak. Hopefully, the Google gods will not have steered me wrong, and this will actually work:
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?
All right, hopefully the poll did not cause this blog post to go kablooey, and we can continue on with our regular “Bits and Pieces” business. Here’s a collection of various MS related items that have caught my attention over the past month or so:
♦ There’s been a lot of news recently about the sometimes nefarious shenanigans engaged in by pharmaceutical companies. As long-time readers of this blog must be aware, I’m apt to go off on anti-Big Pharma tirades, but I promise I’ll try to control myself.
First up, an article from the New York Times about efforts currently underway to force pharmaceutical companies to release all of the research results related to the drugs they bring to market (click here). Hard as it is to believe, it’s an all too common practice in the medical research world for unfavorable data gleaned during drug trials to be suppressed and only positive info brought to light. Studies have shown that only about half of clinical trial results make their way to publication, and the vast majority of those results are positive. This phenomenon is known as “publication bias”, and is increasingly being recognized as a major flaw in our medical research model. In effect, it forces doctors to prescribe drugs without having full knowledge of the effects of those drugs, because unfavorable data is shielded from public view. The problem has become so widespread and troubling that the European Medicines Agency, which oversees drug approvals in the European Union, is considering a proposal that would force pharmaceutical companies to release all research results, positive and negative, related to drugs being submitted for approval.
While some drug companies are making a public show of voluntarily opening up all of their research results, it seems that others are not being quite so agreeable. As this article from the British newspaper The Guardian details (click here), a leaked memo reveals that powerful European and American pharmaceutical lobbying entities are attempting to mobilize patient advocacy groups (many of whom are reliant on pharmaceutical company funding) to raise fears that full disclosure of research results might be misinterpreted and lead to waves of health scares. Yes, the drug companies are trying to get patients groups to argue that withholding negative research data is actually in the public’s best interest. Here in New York City, we’d say that such efforts by Big Pharma take a humongous set of balls.
The roots of problems such as publication bias lie in the fact that we’ve evolved a medical research system that is increasingly dominated by the pharmaceutical companies. As this article from the Australian newspaper The Age nicely summarizes (click here), a joint review by American, European, and Australian researchers describes “how the enormous profit involved in making and selling drugs gave the industry power to influence every stage of the health system.”
Many decades ago, medical research was primarily the province of government and academic laboratories. Over the last 25 or so years, though, as the profit potential of pharmaceuticals has skyrocketed, more and more of our medical and drug research is being funded by the pharmaceutical companies themselves. Can anybody say “conflict of interest”? As an Australian doctor quoted in the above linked article states, ''Asking corporate sponsors to conduct pivotal trials on their own products is like asking a painter to judge their own painting to receive an award.'' Keep in mind, were not just talking any products here. Having painters judge their own work wouldn’t have the potential to cause physical harm to those who view their paintings, but allowing pharmaceutical companies to conduct research on their own products has already proven, on numerous occasions, to have potentially dire consequences on the patients taking their drugs.
Unfortunately, this situation is only likely to get worse, as economic and political constraints are leading governments to cut back on the already insufficient funding being devoted to medical research, as is detailed in this article (click here) about cutbacks to funding of the National Institutes of Health, the main government medical research facility in the United States. The NIH has long been at the forefront of innovating ground-breaking medical techniques and technology, but cutbacks to funding are effectively leaving the organization hamstrung, and are ceding more and more influence to Big Pharma.
Let me state that I don’t believe that the pharmaceutical companies are evil entities intent on doing harm to an unsuspecting public. They are only doing what corporations are designed to do, make as much money as possible. Most of the drugs they produce, including the MS disease modifying drugs, have increased the quality of life of millions of patients suffering from dread diseases. As public companies, however, the pharmaceutical giants are mandated by law to be beholden to their shareholders, not to the patients taking their products. While this has led to the production of many hugely profitable blockbuster drugs, it hasn’t led to all that many cures, as curing a disease pretty much eliminates any potential profit to be made from treating it, effectively violating a public corporation’s legal mandate. As I’ve said many times before on these pages, capitalism is a wonderful tool for creating wealth, but when married to medicine the results can be nauseating. Thankfully, there’s a pill for that.
♦ Okay, I’ll step back from the ledge, and refrain from engaging in a full throated rant. Let’s turn our attentions to more positive fare. Here’s a cool little interactive graphic, courtesy Healthline.com, which helps explain some of the common phrases thrown about in the MS patient lexicon. Just click on the graphic to to open it on the Healthline site, where you can mouse over the words to see definitions pop up. It's really kind of cool…
♦ Here’s a video, presented by Everyday Health and Dr. Sanjay Gupta, about a weighted vest that helps MS patients suffering from lack of balance. Kind of an interesting concept with the potential to help many people, and the physical therapist featured in the video is none other than Dr. Stephen Kanter, who is the PT at the MS clinic at which I am a patient. As a matter of fact, I was just in the room that Dr. Kanter is being interviewed in last week. Can my life possibly get any more exciting?
♦ Oh goody, here’s another piece for my ongoing collection of asinine research studies. It’s a brilliant example of scientific exploration that delves into the mystifying question as to whether or not being told they are JC positive makes patients on Tysabri more anxious (click here). For those who aren’t aware, the JC virus is responsible for PML, the potentially deadly brain infection that has been linked to the MS drug Tysabri. Patients who are JC virus negative have a negligible chance of developing PML. JC positive patients, though, have a far greater risk, in some cases less than 1 in 100. Can you guess what the researchers found? Brace yourself for the shocking conclusion, because the investigators discovered that Tysabri patients who are JC positive are significantly more anxious about taking the drug then their JC negative counterparts! Who could have possibly guessed that patients that are far more likely to get a horrible and potentially deadly brain infection due to the medication they are taking would exhibit more anxiety about that medication than those whose risk is barely registrable?
Reading about this research led me to do a little thought experiment of my own. Given my fertile imagination, I assure you that going through with the actual experiment is entirely unnecessary. After much intense thought and contemplation, I’ve concluded that attaching a small guillotine to my gonads would make me significantly more anxious than not having to cope with the perpetual fear of having my family jewels chopped off any second. Of course, just to be sure, I’d like to run this experiment in real life on several hundred men, mostly pharmaceutical and insurance company executives. Where do I go to get my research grant?
♦ This last video has nothing at all to do with pharmaceutical companies, MS, or medicine whatsoever. It does feature a dog, an omelette and Bossa Nova, though, three of my very favorite things. I hope you get as big a kick out of it as I did…
Well, that’s it for this edition of Bits and Pieces. Thanks for reading Wheelchair Kamikaze!…
Received a one month supply and then insurance denied the rest, in appeals process at the moment.ReplyDelete
No major issues in those 30 days.
I suggest everyone make sure they eat before hand. Seemed to make a big difference in GI issues.
I wish my dog would do that...ReplyDelete
I've been on Tecfidera for a whopping 5 days at this point. The first 2 days, I did have some minor flushing. It was limited to my face/shoulder area, and typically went away after 30-40 minutes. There was also a burning sensation. It almost felt as though I had a sun burn (not painful, just that I was radiating warmth). My face was red as a result. However, being that it's the summer months, it really did appear as though I was in the sun a little too long.ReplyDelete
After 2 days of feeling that, I haven't felt a thing, so I chose "none".
Please keep in mind that I'm currently on the introductory dose of 120mg pill twice a day. On day 8, I'll begin the 240mg pill twice a day regiment. I'll see if there are any responses.
As far as benefits, I can't be certain just yet. My current MS issues are severe joint pain, but I began taking an herbal supplement that assists with arthritis pain, and that has virtually done away with my issues. I'll try taking a small brake from the supplement and see if Tecfidera is offering the same result.
Another issue I've noticed the past few days is that I have been sleepy. I'm typically not very tired, but I've been feeling it a bit. Not yawning, per say, but my eyes are dry in a sleepy kind of way. I wonder if that might be an unlisted side effect. *shrugs*
I'll fill in more info as I have more answers.
I did well on Tecfidera for the first month. Itching and a little flushing in the first week (tolerable). Nausea starting the second week. Then intestinal cramping. A pretty miserable weeks 2-3. Eating a decent meal w. the drug was mandatory. But by week 4 there were essentially no side effects and my energy level was increased like never before. My thinking was crystal clear and I could stay up past midnight! I was able to cut down my Provigil use by half!ReplyDelete
But then my tongue swelled up and because this "might" be a sign of a drug allergy my neuro asked me to top the Tecfidera until we figured out what was going on. The first week w/o Tecfidera was fine, but by week 2 I'm back to my same old sluggish self. The lights have gone dim again.
After being off Tecfidrea for 5 days I took one 240 mg dose. WOW! The side effects were intolerable. It was the worst of the first week and the second all rolled in to a 3 hour period. I thought that I had already adjusted, but I guess that after even just a 5 day washout period I need to start again at 120 mg and build up again. I really do not look forward to repeating the first month adjustment period. But I will, because the increased alertness and energy level make it worth it.
As soon as we get to the bottom of my tongue swelling (it is still swollen) I will happily start the Tecfidera again.
I use a Balance Wear vest - it does need occasional adjustment when you progress or gain and lose weight. Well worth the money if it prevents from falling. Good not only for MS - any balance issue such as Ataxia, Parkinsons or simply aging. Would highly recommend it!!ReplyDelete
What a great post - And it didn't implode with the poll. Worked perfectly! I share your pharma opinions and actually all reasons why it took me so long to start taking a med. On Tecfidera for only 3 weeks. Turned red. Didn't turn red. Now turning red again. And burn when I turn red. It's really a color that is NOT attractive on me at all. Also, a few slight stomach issues, but nothing horrid. Everyone always asks, 'when will you feel better?' Hmmm. Well I know it's working because I have the side effects.ReplyDelete
Hallway Pinball (hadn't hear that one) and a really cute video/ just what I needed today.
Totally fun bits and pieces!
I have been on Tecfidera 2.5 months. I have flushing, which I describe as an internal blow torch coming through my skin! It burns. Extreme itching on face, neck, ears, arms (only up to elbow) and ankles and top of feet. Now I have started getting red hives on my arms. I am also experiencing joint main. Last night I felt like my upper arm was broken. Now it just hurts to raise my arm. So how will I know when to go to the doctor because I hurt my arm or is it just a side effect that I need to ride out? :/Delete
At this point I can't tell if it is doing any good or not. I hate MS!! However I am closer to the Lord now than ever before. He is my strength. :)
I had to chuckle at your JC+ study results. I originally told my doc I didn't want the test because it wasn't likely to change my mind about taking Tysabri. If I got a "positive" result my odds would still be in the range of 1 in upper 200's to upper 300's depending on the study. Since these odds still beat the odds a cancer patient with the most treatable cancer faces if they follow the route of lowest morbidity chance (chemo after mastectomy for breast cancer caught early), I am reluctant to stop taking the drug which has allowed me to resume almost normal life for the past 6 years. Still, Biogin insists patients have the test, and so I did. He told me the results, and now every three months when I go back I have to say I want to continue with Tysabri.ReplyDelete
On the pharmaceutical companies choice of which data to act upon, I will forever remember my internship with a company analyzing the market for new medical technologies. After a month's research, I made my presentation pointing out amongst other things that the only other company providing the good in question was the Red Cross, and it would take 5 years of sales with no costs to produce and distribute the goods while capturing 100% of the market to make up the money it would take to get the product through the FDA approval process. I was then asked about a study which didn't show up on med-line (because it wasn't remotely about their product). Their PR department found it. When I hadn't heard of the study the presentation was summarily dismissed and the project got a go from the pharmaceutical company...It can be scary how things come to market in the U.S.
I have been on BG-12 (Tecfidera) since 7.09. I am now on CONFIRM phase for 3 more years. I am on the super-size dose of 3 times a day (2 capsules). I have had no side effects at all from it. I have PPMS, so it isn't supposed to help me necessarily. But it got me in front of Neurologists on regular monthly visits all on Biogen's dime. Since being on BG-12, which is a month after my DX for entrance into this club, I have gone from a 1.5 to a 6.5 on EDSS (less then 5 years).ReplyDelete
I have been in the BG-12 study for about as long, Curtis. I do have RRMS, and I have not had a major episode since I was diagnosed in April 2009. I do regularly still have the flushing, and it lasts for about an hour. It happens around lunchtime, after my first dose around 8am. It's not bad enough to not take the medicine, though, and taking an aspirin about 20 minutes before taking that breakfast dose does help to prevent the flushing. I have several friends that tried Tecfidera and weren't able to stay on it, which is unfortunate.Delete
The 'vegetables' in the omelet my dog makes for me are 'lighten up', 'don't take yourself so seriously', 'throw the ball and watch me jump and catch it out of the air with my awesome eye/mouth coordination' and 'let me snug you to sleep'(my hubby works nights).ReplyDelete
I have been on Techfidera for 2 months now with very little side effects and only then during the first couple of weeks. I also recommend taking the pills with a little bit of food. I was a 9 year user of Rebif. Now after the switch I have less muscle pain, sleep better, less depression, and no more injection site problems. Yea!ReplyDelete
I just got my first shipment of Tecfidera today. Will be starting it in the morning. I hope all goes well. I am 36 year old male who has been dx’d since 1999. I was having double vision and went to the Dr.’s. He told me I possibly had a tumor on my brain. I was supposed to get married in two month’s, So my future wife and I were very worried. A month and a few tests later… the Dr. said Don’t worry, Its only MS.ReplyDelete
He started me on Copaxone. Everytime I would give myself the shot, I would have a 50/50 chance of having a adverse reaction and after passing out and a pleasant unconscious trip to the hospital, he took me off the med and put me on Avonex. Which was alright, but at the time I was working, so I would take it on Friday night and pretty much stay in bed until I had to go to work on Monday.
So the Nuero. Started me on Tysabri. I loved the stuff and was on it for over 5 years. Then the JC virus was being connected to PML. And wouldn’t you know it, I was positive. So my Nuero yanked me off Tysabri and tried me on Gilenya. This was the worst yet. I got canker sores in my mouth so bad I couldn’t eat or even drink. After losing 45 pounds, He took me off of the pills.
So I went a year untreated and It was OK at first, But then I started relapsing. Nuero said I am running out of options but I needed to be on something. Tecfidera will now be my drug of choice. My sister turned me on to your blog and I will keep you updated on my journey. Thanks, Sam
I had the same reaction 2x with Copaxone injections, but also had bloody noses, very high blood pressure, which I have never had in all my life. Went on the other ones that you are taking, adverse reactions. My neuro decided just to see how it goes, I would have some relapses, some serious some minor (I was officially diagnosed in 2000). I am on the start of my 2nd month of 240 mg of Tecfidera. I have bloating, looks like I am pregnant, nausea, wake up at night several times very hot and sweaty. Most benefit is the leg cramps seem to be subsiding and I am sleeping without a sleep aid. Definitely make sure you eat with Tecfidera and you will probably turn bright red and feel like you have a bad sunburn, it lasted with me 1 hour. Good luck, hope it works for you.Delete
I find that the aspirin really really helps with the flushing and burning. Good luck Sam... you've had your fair share of reactions!Delete
Today is my second attempt at starting Tecfidera. The first go around went well (aspirin and food eliminated side affects of burning and GI upset). On day 6 of the increased dose, I quickly and violently became ill with excruciating abdominal pain. I began vomiting and had diarrhea; landed at the emerg dept. Not one doctor/pharmacist etc. knows about this drug or can offer any insight. They kept me in over night thinking it was gall bladder but ultra sound cleared that. The answer was "it could be food, it could be a virus, it could be any medication". I stopped taking Tecfidera until today and will make another attempt. If it happens again, I can positively identify it to be that medication. My case management nurse (I live in Ontario, Canada) hasn't heard of anyone suffering the way I did and I can describe the reaction as "praying for death!" I know that really isn't the case but that is how bad I felt. I am going to take the poll, if it is still open, after I get passed the first 2 weeks of this attempt. Thank you very much for your work!! It is amazing for all of us I am sure! SandraReplyDelete
I had the exact reaction you describe. It occurred about 3 days into the full 240 dose. I spent 5 days in the hospital, because the diarrhea wouldn't relent and pretty severe dehydration set in. The stomach pains were horrible (far worse than anything I had ever experienced before -- even kidney stones). There was also intense dry-heaving and the flushing all describe. Needless to say, I stopped taking Tecfidera and my neuro concurred. Hope that helps. Best of luck!Delete
Oh Whit... I was so hoping there wouldn't be a reply with someone who had the same experience!! thank you so much for taking the time to add your experience. Now the brain will be my worst enemy, practicing mindfulness aside. In any event, I will forge ahead for 2nd attempt with my fingers and toes crossed. I don't ever want to feel that bad again!Delete
I just started day 3 of the 240 mg dose...... so i was a little discouraged to read what has happened to some but at the same time reassured that some of the things i have experienced, others have too. the cramps in my legs and the acid reflux has been the worst for me today. I have experienced the intense flushing once at the first dose of 120 and then again at the first 240mg.... and very teary-eyed at alot of things. ( This is what bothers me the most, because I am a very positive happy individual. Not so sure.......Delete
I had similar experience. My doc suggested three weeks at half dose and then trying again. It worked. I still have minor flushing, but no GI distress. Good luck!Delete
Hi Kim. Welcome to the battle of the unknown :-(. I pray that you have a weaker reaction than what poor Whit or I had! I take panteloc for the acid reflux and I think it keeps it at bay slightly. I woke this morning with abdominal pain which I know is the prelude to an ugly reaction. I am not certain I can continue and my biggest hurdle with that decision is the disappointment from my loved ones around me. Every human body reacts differently to these meds so I'm hoping you are able to manage! Best of luck!ReplyDelete
Hi - I started Tecfidera in July and am on week 3. Some days I flush, other days I don't. I find if I eat a high-protein meal and drink lots of water, there is no flushing and fewer stomach symptoms. I am finding week 3 to be harsher on my stomach - very bloated, nauseous at times, and strange gurgling sounds. My neuro recommends pepto for stomach issues which has helped some when I need it. I also doubled up on my probiotics in hopes that it would help. Like some others, I also noticed being tired (usually a few days into the new dose) and a harder time sleeping (wake up hot). Good luck everyone!ReplyDelete
Been on Tecfidera since it was available. First week I had little flushing and minor stomach stuff. No problems since, going on my third month.ReplyDelete
I'm just curious (and I really don't intend to offend anyone): those who have had more intense reactions to Tecfidera, approximately what size are you? I weight about 125 lbs., and as I described above, my reaction was horrible. However, I was just fine on the half-dose. My hope is that body mass has something to do with all of this, and Biogen will eventually release the 120mg as a regular dose. I know there isn't much research to support that dose being effective, but it has to be better than nothing, especially for those of us who are on the smaller end of the spectrum.ReplyDelete
Hi Whit, I weight about 125 ibs. My side effects have been mild for now (thank goodness). I am on the 240 2x daily now. I have been on Tec since July 11. First I started taken 120 for 5 days, then began the double dose. Once finished, I began 240 the same way and tolerated the meds with mild reactions. I hope it gets better for you.Delete
Hi Whit, I don't want to announce my actual weight, but let me just say I've had severe reactions to the Tecfidera, and I am over weight for sure (200+). I get the occassional flushing which I find to be tolerable and goes away quickly enough, but the gastric problems have been horrible. My neuro dropped my dosage to 120mg twice a day for a limited time to see if I just needed a longer tritation period, but I'm on week 8 or more and still can not tolerate the full 240 dose without major nausea, discomfort, and occasional vomiting. I'm okay on the half dose. My plan is to talk with my neuro at my appt next month and see if I can convince her to let me stay on the 120mg.Delete
I weigh 95 lbs and I am very tiny. Like you, because I am smaller I opted to stay on the smaller dose. I have been on Tecfidera 120 x a day for about a year now. Still have mild flushing but it doesn't bother me anymore, because I am used to it. I am scheduled to go get another MRI and we will see if I have anymore lesions. I do plan on continuing on the lower dose and crossing fingers that it is doing some good. So yes there are a few of us out there on the lower dose :)Delete
Hi, all. My neuro. recommended Tecfidera, but I am quite hesitant. I tried an antihistamine that damaged me in 1998 (Hismanal). I still suffer from the effects of using that drug and therefore might be too cautious. I want to stop the progress of my illness but fear using Tecfidera might be detrimental to me; Which would mean my harming myself once again by trusting clinicians and the less-than-reliable FDA. Guess I will have to risk it in hope of any gain. Will let you know how I do. Until then, wishing each of you well.ReplyDelete
Whit, I weigh 109 and started the 240 dose today. I did fine on the lower dose and am a bit nervous to see what today brings now that I am on the higher dose. I will let you know how things go.ReplyDelete
I took it for 31 days. Tried with food, antiacids and other suggested methods. By the 31st day I was going to either go to the hospital with cramps or stop taking the pills. I stopped for 2 weeks then tried again. The first pill put doubled me over with cramps for almost 2 hours. I guess it is back to Avonex for me.ReplyDelete
i took tecfidera for two days. i felt like i was on fire from head to toe. was so red i looked purple. itched badly then my blood pressure spiked and fluctuated wildly. i wonder if anyone else had bp issues with it. or if i have something else wrong with me. ive never had high bp before.ReplyDelete
I attempted to discuss serious concerns about these new drugs in my west vancouver ms group and was told to go to the curb with negative concerns! Has anyone heard about this Fampyra a walking improvement drug................? There is a major drive to prescribe it. By the way, my sati vex, fampyra and fentanyl are no longer covered by pharmacare. So please realize here in Canada we are being denied financial coverage for specific drugs which i need for SPMS. There are special request forms which are are ridiculous considering I was covered for years.ReplyDelete
We are not given all the facts about these drugs such as tecfidera . It is a deliberate crime to with hold information about crucial finds on concerns and side effects. Thank you for this post. Thank you to all that post comments.
I have had MS since 1999 and have been on avonex and rebif most of the time. I recently tried tecfidera because the rebif was causing muscle weakness and I could not tolerate it any more. I was on tecfidera for only four days and the side effects caused me to end up in the emergency room with severe abdominal pain and blotting. for me this was the worst drug I have ever taking and if anyone has acid reflex problems you should not take this drug it is awful.ReplyDelete
I was dx 4 years age at age 59. Lucky me I got it in my older years. I was still working 2 years after dx. but I got to a point I could not work any longer. After 15 months on Avonex I got off of it I had no quality of life at all. God afful stuff! Started Tecfidera 2 days ago. Good or bad I will try to share with others here. Keeping my fingers crossed. Best whishes to all.
Mark T. aka: steammachinist
I am 21, diagnosed with MS at age 16 after MRIs elucidated definite new lesions after my initial catastrophic and highly progressive first episode at 14. Today I have no symptoms at all and despite almost dying from MS and having occasional very small new lesions over the years, I resisted ever starting an MS drug. Recently I received the FDA drug facts for Tecfidera. I study all the drug facts for all MS disease modifiers,( Tecfidera right now) and I often wonder what the less favorable studies discussed in this page might show. I am looking at a "Confirmed progression of disability graph". I am impressed that such a study was actually done, since when I was diagnosed the best that existed was data showing a decrease in observed lesion number for non oral MS drugs (virtually useless to someone who has had 2 or 3 new lesions in 7 years BTW). Anyway after 96 weeks the placebo group experienced an average of 10.7% more confirmed progression of disability over the group prescribed the approved dose. Other numbers are quite promising as well. However, I have a very hard time believing clinical data, since people are not quite as consistent as lab rats that are all nearly genetically identical and cant choose to leave the study anytime they want. 72% of the patients taking the current approved dose stayed in the study for 96 weeks or more. Only 64% of the placebo group stayed for 96 weeks. This tells me that I am not observing patient outcome but rather an endpoint for the 72% that could tolerate the drug. I hypothesize that people that were doing particularly bad in either group (hence double blind) were strongly suggested to leave the study at 24 weeks right when the test group disability progression begins to improve over the placebo, and then possibly again at 48 and 60 weeks when the placebo group dramatically accelerates in disability progression. Anyway I think everyone should become familiar with the very specific facts that the drug companies report. Also, an exceptional diet including all essential and necessary micro and macro nutrients, as well as limited processed foods, remaining active, supplementing D3, anti-inflammatory and antioxidant organic supplements, and a positive outlook have made an exceptional improvement to me and the sate of my MS. Find what works best for you!! Take care everyone!ReplyDelete
Just LOVE your reply!!!! We are so like minded:-) I have only had had 3 attacks in 13 years because I have done what you just described.... Great to hear your take on MS -Thanks :-) Marie LouiseDelete
can you share some of your dietary tips pls?Delete
day 1 on tecfidera today, mild burning sensation on ears and face after four hours, no redness or any other effectsReplyDelete
thanks all for tips, had a nice breakfast sandwich prior to pill and a normal dinner with nighttime dose.
dx 1 year ago this week, did 6 months on rebif and developed hypothyroidism and depression, happy to be off it and enjoying life!
I wish everyone luck (myself included ) and hoping for the best.
I am happy to have found this blog and throughly enjoy your writing stlye, thank you!
I'm starting Tecfidera soon and I've been nervous about it. I was diagnosed about 7 years ago and I have been on Rebif twice, with two breaks for babies. I had a horrible time with Rebif the first time around, so much so that after I weaned my oldest, I drug my feet getting back on it and ended up with the worst relapse I've had so far. It was easier going into the neuro this time with the promise of a new oral drug. Somehow, between my doc's office and the Biogen folks, my info got mixed up and my meds haven't shipped yet, so I've been nearly three months post-weaning with no treatment. Plenty of time to obsess over side effects and worry about every little tick or weirdness in my body that might be an episode starting. I'm really glad to read about all the people who've had mild to no side effects. My neuro has also developed a modified titration schedule with a more gradual ramp-up to full dose for her patients that has helped lessen the side effects. I'll be following that. Thanks everyone who has posted and thanks for the great blog. It's helped immensely!ReplyDelete
I started Tecfidera on 3/27/13 was diagnosd in 2008 but I'm sure I had it at least 5 yrs pior was immediately put on Rebif that stopped working as did the copaxone so this was my next option. Tysbri was out bloodtest was positive so I said no way. Had to be off copaxone 3 months before starting Tecfidera then was told at least 3 months till it kicks in with in that time I had 3 relapses and was given IV steroids 3 days then the pill taper. To the point I do think it is doing something I still slurr my speech,stumble and fall for no reason but not having to do the horrible injections that burned like bee stings for what seemed like forever that alone is reason to celebrate that and relapses have stopped. I get my 1st MRI and blood test the end of Sept to see if its hurting my organs and to see if it has reduced old lesions or if there are any new ones.ReplyDelete
3 months on Tecfidera and I feel awful. Low energy (worse than it was before), terrible burning and itching in my feet and hands, gastro-distressed. I have heard about a diet for improvment. What is it?ReplyDelete
I just started the half dose 3 days ago and I have had flushing with redness that is similar to when I and if I take niacin, but no gastro effects. I am female, 5'10' 165 pounds, RRMS, mid thirties. I do think that it has made me a bit tired, which kind of sucks, but I anticipate that will reduce over time. One thing that I think that it has already helped me with--and it may be way too early to say this, so I am saying it with a virtual whisper--is urinary urgency. For some odd reason, my urinary urgency issues have been way better on this 3rd day of Tecfidera than they have been in so long I cannot remember. I wonder if inflammation is already lower in my body. I went over 7 hours without needing to pee... and that was even after having cocktails, which would normally have me unsuccessfully racing to the toilet every 20 minutes. Those of you that deal with this issue will appreciate the VACATION from porcelain that was. ;)ReplyDelete
Have any of you experienced benefits from this drug? If so, what have they been? I'd like to hear more about them. I am hoping that my chronic pain will improve. My bladder issues and chronic pain are my worse symptoms. If those two issues improved, I would be like a new woman.
I wish all of you the best and I am very sorry that this drug hasn't worked out for everybody on here, because it does seem like the most promising drug on the market so far.
I have also experienced a decrease in (shhhhhh!) urinary urgency, particularly at night. I've been on Tec for 4 months now. I used to get up two times in the night to pee ... last month, that dropped to once a night. In the past couple weeks, I have slept the whole night - that hasn't happened in years!
There is nothing in the literature about it improving bladder function, but I have not changed anything else in my life. Who knows? Maybe others will 'fess up about this improvement, too ...
Just started today. I had been encouraged by the low side effects I HAD read until 2 hours after my first dose ... the "flushing" was so intense my work wanted to take me to the ER. Face, neck, back, arms. I am at work, so I refuse to take off my pants and see how far that flushing goes. I still look a little like an oompa loompa 3 hours in. I was not aware the itching was going to be so intense. But I tend to reject all meds routinely. After that initial flare, the itching has already subsided. I was surprised the reaction was so quick, and then I started reading ... I try to never read about others symptoms because I am afraid psychosomatic neurosis will certainly set in.ReplyDelete
Knowing how my body tends to not like drugs, I am a little worried to see that the symptoms are a little more intense than my initial understanding. But the 1 out of every 4 weeks I spent sick in bed with Copaxone didn't set well with my need for employment as a single parent. And the knots/bruising/welts with Avonex drove me to tears.
So, oompa loompa status, I can dig. Plus, secretly I am hoping the nausea, vomiting and diarrhea do hit me. I've put on 70 lbs since diagnosis in 2008. I've lost 20, but would really love to kick start that weight loss again. I am a glass half-full sort of girl.
As always, I wish each of you the best in this ongoing effort to redefine normal one day at a time.
I was diagnosed with MS 9/12 although I have likely had it for 10+ years. I went on Tecfidera in April soon after the FDA approval. I initially had minor flushing but no other major problems for three months. I began to notice increase levels of fatigue to the point where I had to take several naps each day. I also began to notice swelling in several lymph node regions. My neuro said that he hadn't heard of any similar reactions but suggested that I stop the Tecfidera. Within two days, my energy level returned to normal although my lymph nodes remained swollen. After seeing some other physicians for the lymph node swelling, we determined that it was probably unrelated to the Tecfidera and instead caused by a virus; the lymph nodes finally returned to normal. I was still fearful to go back on the Tecfidera because of the extreme fatigue. My neuro recommended a restart of the Tecfidera with a prolonged titration - 120 each day for two weeks, 2 - 120 each day for two weeks then 1 - 120 and 1 240 for two week and finally the full 2 240 each day. He also prescribed Provigil which helps alleviate the fatigue. I started the Provigil 3 days before the Tecfidera arrived and WOW, I thought that I had my old life back again. I was thinking clearly and had normal energy levels. Unfortunately, when I resumed the Tecfidera (just 120 mg per day) the severe fatigue returned. I am going to tough it out for a few more weeks to see if things change, but if not I am going to drop the Tecfidera again.ReplyDelete
Just to update, after the initial yuck on day 1, I had very little side effects. I was warm. I feel like I had an early glimpse of menopause with the internal thermostat issue. Just switched to the double dose, and yes, there is some abdominal cramping, but so far so good.ReplyDelete
The GREAT news is that I am also experiencing an increase in energy. And for the first time in a year, I am getting sensation back in my right hand, which has had no feeling for nearly a year. Now, as a point of full disclosure, I suffered a major new attack last September. I am steroid resistant, but my insurance denied both Athgar and plasmaferisis (the second I have tried before and is my miracle worker of choice), so docs only opted to treat me with steroids .... again. I do not think that my attack from last September ever abated. I don't know if the anti-inflammatory portion of this drug is having an effect on calming down the 4th of July celebration that has been occurring in my brain non-stop for the last year, so the two could or could not be related at all.
I will say, I don't support medications, I have a hard time believing the reported effectiveness of said drugs that have been on the market for less than 20 years and prior to that there was no adequate base line of diagnosis or progression of this disease, and I especially don't approve of meds that are so ridiculously overpriced that I can't really conceive of it is a viable option because it is not other people's responsibility to provide for my personal healthcare... .However ... I am totally digging the HOPE and renewal that I am experiencing with this medication.
Thanks so much for posting this poll! I've only been on it 2 weeks so I've been eager for other information and experiences. I titrated more slowly than Rx (took 2 weeks rather than 1 week to work up to the full daily dose) but so far, 16 days in, I'm doing well with only mild side effects. From the get-go I have made sure to take it with a full meal (protein, fat and carb) and premedicate with baby aspirin and Zantac.ReplyDelete
I have been on Tecfidera 4 month. Mild nausea in 2nd month. Previously on rebif, tysabri & copaxone but none were able to stablize ms progression. While no promise of improvement. For the 1st time since dx in 2006, finally stablized. Wake some mornings walking pretty close to normal, though I have been dependent on cane & finally a walker. Now have somedays at home where I am able to walk with little or no use of cane or walker. Shortly after starting tecfidera, I can now say I don't "feel" sick. Also have "desire to do more for myself. Having great faith and giving God credit. Don't know where tecfidera will take me but great appreciate where it's brought me. Was sure I had MS 10 years before dx. But I also know a positive outlook has been greatly beneficial. Hope many others are helped and hoped this encouraged someone else. Best wishes to all of us that's journeying the path.ReplyDelete
I started Tecfidera in June. By August, I was having severe, random, migrating joint pain. One day I could not use my arm. A few days later, it would be a hip. It has happened in both shoulders, hip, wrist, elbow, and jaw. 12 or 13 times at least in a little over 2 months. My neuro told me to stop the meds for 2 weeks. The symptoms did not go away, so he said to start it again. I have since been tested for RA, lyme disease, a bunch of vitamin deficiencies, thyroid, etc. and all tests are normal. I don't think there was enough data to make an accurate list of side effects for this medication. I have stopped taking it and don't plan to re-start it. The joint pain has been debilitating, and is not completely gone yet. My last dose of Tecfidera was Oct 7. I now understand when people say a treatment is worse than the disease.ReplyDelete
Been on Tecfidera for a month now with relatively no side effects. I had slightly flushing/itching on my wrists after my first day, but nothing since. I've been noticing some minor constipation and runny nose, but those effects are very manageable. I hate to hear about all the negative experiences that some have had and I hope they find something that works, but I wanted to reinforce the fact that for many of us, Tecfidera is easy and side effect free (more or less). Looking forward to hearing the impact it has on relapses/lesions etc. over the next year or so.ReplyDelete
Wheel Chair Kamikaze: well done! I am a Canadian living in Westchester. I was diagnosed with PP MS 11 years back and so far I have been very very lucky. Still walking, though with a lot more effort. Love your blog and videos.ReplyDelete
You mirror my disgust with the Pharmaceutical Industry's amazing ripoff of the American Health Insurance business. It will not change as long as most Americans continue to understand the issues as "The gummint can't do anything right, Leave it to the private sector and competition will bring prices down." This might apply except that the competition is purely theoretical. The reality is COLLUSION Insurance/Big Pharma/DEA/retail Pharmacies, That primitive misunderstanding is a big reason that US health care costs are about 2X as high per capita as other industrial countries. But apparently that is better than "European style socialism." Oi.
My current Copay for Copaxone is $15/month. Of course the other $2500/mo is picked up by my insurance company. And that MAY be the reason a family policy for me and my wife cost $2000/month (Will come down to 1/2 that with the ACA). At least we can GET insurance due to NY State regulations.
Another question for anyone who has an opinion: When I moved to the USA I assumed the American MS Society might provide information and support. My experience since is they don't have any info you can't just get with a Google search and they are constantly after me to donate. Do they do good work? I'm not sure. I was kind of shocked when I asked a couple of reps if they knew where I might buy some smoke (As you may be aware it is a great help with symptoms) Their response was as if I was asking about kiddie porn. MS is not a PG rated disease and I remain amazed that NY, otherwise a liberal bastion, is the only state in the Northeast without medical mj.
I know, many (most) here have worse problems, but the American fuss over people smoking a simple weed for symptom relief is mystifying. Strange and amazing country, but I sure as hell would have stayed in Canada if I were poor.
It appears I need to do more research. I have been on Tecfidera 3 months. Normal WBC prior to taking Tecfidera. 3 month checkup shows lowered WBC. My understanding is the purpose of the drug is to lower the immune system as any autoimmune disease benefits from this. But now that mine is lowered..I am rethinking this whole process. Interestingly I have an infection in my foot that is slow to heal and I am certain this is why. I asked my Neuro about risks because I work in hospital and she said my immune system would not be compromised and it would be fine to work in hospital. I'm sure many MS patients work in medical setting. Confusion...ReplyDelete
I have been on the med. since last December, and my ms has worsen. has any one had the same experienceReplyDelete