Thursday, December 12, 2013

Everything Changes

December is here and, yet again, it is time to embrace the new.  Another year of holiday cheer and celebration will roll into another year of unchartered territory.  The New Year always brings with it changes.  Resolutions for change and hope for that magical caveat to everything: better!  Perhaps you know what you need to do to make everything ‘better’.  You may look at eating healthier than last year or addresses your own special list of bad lifestyle habits (to do them less than last year or not at all).  Bad habits can be easy to find, often less easy to fix but the New Year is always that time to try.  Maybe that ‘better’ is improving on the good that you have already built in years’ past: spending more time with your loved ones, reading a bit more or working out more than you did last year.  Whatever the reason and whatever the change, the goals bear the same striking resemblance: to make the bad good, make the good better, make the better…….well, better yet.

My December usually rolls into unchartered territory just a little bit more than most people.  That January 1 change is preceded by my December 28 change.  My birthday.  Birthday resolutions and hope for change rival those of New Year’s.  Put them together and the inspiration for change can be quite exhausting!  Over the years I have embraced some of my biggest changes and improvements during the Holiday-Birthday-New Year time.  It’s always about discovering what I can do to make myself better.

This year is different…sort of.  This year is a time of change but the focus is less ‘what can I do for me’ and more about ‘what will happen to me’.  Allow me to backtrack a bit…
2012 into 2013
MS life is normally a marathon of perpetual ups and downs.  Recovering from the downs and spring-boarding into a new level of ups has become my pattern since I was diagnosed in 1999.  2013 started out with great plans for that next spring-board.  A tough October and November left me knocked down quite a bit; another round of infections and hospitalizations had me on that “Medication Merry-Go-Round” of trying to find the right combination (my MS friends know this joy all too well).  I was focused on the ‘better’ I would see in 2013.

For months I struggled to regain the strength, energy and control lost after my prior year’s bout.  I didn’t succeed.  The general consensus from my neurologists, both at the VA and through local hospital networks, was that my MS had transitioned from relapsing remitting (RRMS) to secondary progressive (SPMS).  I am an average statistic to the MS-community.  I was diagnosed with RRMS 14 years ago.  In a VA research paper, the prognosis trend showed “twenty-five years after the diagnosis of RRMS, 75 percent of patients will have converted to SPMS”(1).  The cause, exact prognosis and cure are still a mystery but statistically my trend is clear.  My disease modifying treatments options are minimal-to-none; my disability progression will likely be steady and unrelenting.  It’s hard to find the ‘better’ in this situation.

As we come to the end of the year my next path has taken shape.  After 14 years, I am no longer on any disease modifying medications.  I am enrolled in a Phase IIb clinical trial for the treatment of SPMS.  The goals of the treatment are “stabilization or improvement in a patient’s MS disability.”  For months, as I dove deeper into the details of this clinical trial, I was constantly reminded of the numerous caveats and disclaimers:
·         I am in a 2-year, randomized, double-blind trial.  There is a 50/50 chance of receiving the treatment or merely a placebo with no medicinal value.
·         The “study”, “trial” and “evaluation” is just that.  The treatment has not been fully evaluated, so even if I get the actual treatment it may not be very effective…if at all.
While enrolling in the study these facts are reiterated over and over.  To consent for this treatment, I had to acknowledge that I understand these points and all the risks involved in a clinical trial.  I am reminded that this cannot be considered a final treatment option, as it is not fully evaluated or approved. 

Translation: it may not work.  Even if it does work I may not actually get the treatment.  Even if it does work and I do get the treatment it still may not work for me.  That is a lot to take in!

So I consented.  I agreed to the trial, and that I understand all the risks, and that I may not actually receive the treatment, and that if I do it may not work, and that if it does it may not work for me.

…but what if it does?
2013 into 2014
So here I am ready to embrace the new.  The holiday season is in full swing.  My focus is already underway for making what is great in my life that much better.  My family and friends are at the center of this year’s celebrations.  December 28 will roll into January 1 again, like it has 41 times before in my life, but then it rolls into my first treatment on January 3.  I will go through new, unchartered territory next year.  I will change significantly in 2014.  Treatment or placebo, effective or ineffective, improvement or decline.  One way or the other, my MS will change.

It’s going to be one heck of a ride!...and a great story for 2014!
I am looking forward to keeping you up to date on my adventures!

Kevin Byrne - Portland, OR

(1) Saisho Mangla, BS,  Seema Jain, Stephen Selkirk, MD, PhD; Disease-modifying agents in progressive multiple sclerosis; Department of Veterans Affairs Journal of Rehabilitation Research & Development; Volume 48, Number 10, 2011; 1224.