(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…