It Finally Happened #gilenya #multiplesclerosis

Yes, I know I said the party was over, and truth be told there's nothing left here on this blog but the confetti on the floor and a bunch of empty solo cups to pick up.

But for the entire duration of this blog, which has been about my experience in the TRANSFORMS clinical trial for the MS drug Gilenya (fingolimod, FTY720), I never had a relapse.

I guess this blog was my lucky rabbit's foot. I should have kept it going. The minute I called it quits (and yes, I realize it's coincidental, but the irony amuses me) I have a bona fide relapse.

For the past week or two I have been suffering crushing fatigue. No all-nighter in my 20's could ever have topped this. A feeling like Horton is sitting square on the center of my chest.

Then, when I'm able to shove him off my chest and become vertical, I realize karma thinks I'd look faaaaaabbulous in a lead suit.

Alanis Morissette left a verse out... "like gaining weight, when your legs don't want to move". I'm serious. I was stuck in bed part of that time taking comfort in snacks because they made me feel better. Thank God the worst of it was over after only a couple weeks or they'd be cutting a hole in the wall to get me out of this joint.

I called my neuro when I finally decided it wasn't just hypochondria getting the better of me (is there an opposite of hypochondria because I think I have that now. Whoops, no, there I go begin a hypochondriac so I guess I'm good).

I went to have a checkup at the clinical trial center and they did the EDSS on me. I had increased weakness in arms and legs, numbness in parts of my forearms and calves, and for the first time EVER I couldn't complete the 500 meter walk.

They always made me do 24 laps of the study center hallway which measures out to be a total distance of 500 meters. I have always completed it (one time in just under 10 minutes), and always unaided.

Yesterday I asked for my cane after 2 laps and had to cry "UNCLE!" after 18 total laps. The study coordinator said "wow! something really is going on, isn't it!"

Duh!

So I will re-end this here now that there is an ending and "Girl Has Relapse".

I'm not gone, however. My new obsession, besides writing for www.healthline.com, is my site, www.partnersinresearch.org, where I'm hoping to educated people who are curious about clinical trials for MS what it's like from a patient point of view.

Also, stay tuned for an update on where I'll be blogging just any old stuff. I need a place to vent and this blog is too confining. There's more to me than my MS, after all. :)

Peace out.

The After Party #partnersinresearch #clinicaltrials #multiplesclerosis

My story here really ended a long time ago when I exited the TRANSFORMS trial on January 20, 2011. The show was over, but I've just been hanging around, excited to connect with so many people who have found me here on my blog and followed along.

This blog, for those of you who are just tuning in, has made a spectacle of itself as it was discovered by big pharma (thanks, Craig Lipset from Pfizer!) and a surreal conversation began. From that one encounter, a bridge was built between the real live trial patient (as opposed to anonymous Donor of Data) and the people behind the clipboards. Here's a fun fact: THEY'RE real people, too! Passionate and dedicated to their life's work, individually they are not nearly as evil as most of us perceive.

I attended the Disruptive Innovations conference and was an oddity to be examined all over again, as they puzzled over just how an industry so regulated might speak around the gag in their mouth and have a real interaction with those of us lab rats behind computers, engaging in social media. It's become a topic very near and dear to me.

Because of this conversation I have been propelled by the force of destiny into the role of patient advocate, and have had the honor of attending several conferences to represent the clinical trial patient and speak to the unmet needs of the patient side of research. I am not unwilling to assume this role, but I know what that girl at the Springsteen concert must have felt like when she was pulled on stage to dance with the band.

Big Pharma pulled me onto their stage and I'm trying to make my dance matter. Whether or not it was ever my intention, at the start of this blog, to become a patient activist seems not to matter any more. What's done is done and I feel the weight of responsibility on my shoulders. I want to represent for patients everywhere and give a voice to those who feel they have no voice.

I was once terrified to enter a clinical trial, but equally terrified of the suffering my MS was doling out. I started this blog when I was a trial patient hoping for a modicum of relief. The incredible benefit I got from that journey–having not had a relapse YET since taking the very first pill on Aug. 20, 2007–has bought me time to do the bigger things I believe I was meant to undertake.

First with the blog, then with Novartis' "Guide Network" of patient speakers for their marketing program, and now as a patient advocate, I go through doors when they open for me. So far, I haven't been disappointed yet.

So, I think it's time to move on. I know I announced blogging my extension trial but wouldn't you really rather go watch paint dry? I mean, it's more exciting, as it turns out. Nothing to see here, people.

Also, considering the name I have chosen for this blog and how closely tied to the medication most of the content is, I have outgrown the desire to post here. It will stand as a testament to clinical trials and the difference it made in my life, but since I have departed from being a part of the advertising campaign (the Go Program) for Novartis, it's only fitting that this blog be put to bed as well.

What started out as a hypochondriac keeping a journal of her clinical trial turned into a platform for so much more.

I'll still be blogging, but stick this one with a fork - it's done. To limit myself to be forever seen as merely Novartis' biggest cheerleader is too confining a container. I'm thinking outside the medication box now. Moving on to bigger and better things.

The day I got my nails done to match my Gilenya box. Hard core cheerleader. :)

Please join me, together with my friend Anne, who was also a clinical trial participant and Gilenya Guide, as we embark on a new call to action... our brand new website....

www.partnersinresearch.org

...where the conversation about MS, clinical trials, and how you can become a patient activist continues.

Partners In Research is intended to be a place where those who are interested can find out all they need to know about clinical trials. We will be expanding the content to include informational videos on the topic of research and adding blog posts from a patient perspective to help MSers see what a study is like from the inside.

We have just launched our Facebook.com page as well at:

www.facebook.com/partnersinresearch.org

I'll miss you, so please come visit over at Partners in Research! :)

Thanks for playing along!

Subject #0008 Version 2.0

My part in the historic TRANSFORMS trial which helped bring the long-awaited, first ever, pill form of treatment for multiple sclerosis (MS) to market ended with my exit date of 1/20/2011. I remember being terrified to start that trial. It contrasted sharply to the day the extension ended and they had to physically toss me from their study center back into the cold, cruel, unsupervised world.

They did so with a vague promise of a future "Extended Study" as soon as everything is lined up. I would be the canary in the coal mine, offering advance notice to those newly started on the drug in case something were to go terribly wrong over the long term.

I kept my study coordinator's cell number on speed dial and would occasionally call to be the squeaky wheel in need of grease, pestering her about when that study might start.

More than two years passed and I gave up hope. Friends in my MS circle who had also taken part in the early trials for Gilenya were sharing news of starting the long-term study. I was as disappointed as that one kid in grade school who comes in on Monday to hear all the happy chatter about the birthday party they missed over the weekend. Nobody invited me.

Then one day I got an email from my old study coordinator asking if my mailing address had changed. She's the kind that likes to remember you with a card on your birthday or at Christmas so I figured it was something along those lines. Making one last feeble attempting at getting my squeaky wheel greased, I wrote back saying the address was the same and inquired if she heard anything about the long-term trial.

Much to my surprise, the email I got in reply, which contained no exclamation points but was brief and to the point merely stated "I'm sending you the IC to look over for the long term trial." The "IC" being the Informed Consent. She probably sent me the email because she knew a phone call would result in maniacal screeching on the other end of the line.

Although I read it cover to cover, there wasn't anything in there that could dissuade me from joining. I have been waiting 2 years, 4 months, and 3 days for this stack of papers to be in my grubby little hands, but who's counting?

So, here we go again! I had my entrance tests all done on May 17, 2013 when I officially began this long term study. I went armed with my camera and made sure everyone knew "I'm blogging this", but I think most of them just thought I was weird.

The shots I got–for your viewing pleasure

 There is a Quality of Life questionnaire this time, same as before. When I see these questions, like, "Do you feel you are a burden to others?" or, "Does you MS make you feel alone?", I feel so sad for anyone that has to answer yes in order to be truthful. What our MS robs from us is often more invisible and less obvious.

 One of the best perks about the study is being able to go back to the generic, utilitarian bottles. Who cares that they aren't pink and orange with a catchy logo? I love my pills no matter what
they look like on the outside–it's what's inside that counts! And these bottles are so much easier  to manage for those of us suffering from the disease. Who has time for "slide this out, flip this down, try to push a pill through industrial-grade aluminum without crushing it, and then TRY to get the whole thing all flipped, folded and slid back to normal"?

 They have an all new, state of the art, peg test now! Nothing but the best this time around! See this post for the jack-o-lantern bowl we used last time and you will no longer wonder why I scored better this time.

The story goes that the nurse who first used the pumpkin bowl to administer the test did so without authorization, however, for the sake of consistency throughout the remainder of the trial, we were forever punished with that slippery, contoured, deep sided pumpkin bowl. I do not miss it at all. And now everything seems to be a uniform (Gators?) shade of royal blue or light blue.

  I had forgotten that half of my bodily fluids would have to stay behind, sucked out of me via a sharp, pokey needle, the likes of which I thought I'd never have to face again. I had forgotten the First Rule of Clinical Trial Visits: fluff up your veins by drinking lots of water to make blood drawing easier.

 The very last picture I got was of their brand new MRI machine. This replaced the old monstrosity they had, requiring the removal of an entire wall to get the swap made.

The surprise MRI was the only scary part for me this time around. You see, I had no idea it was even scheduled for the 17th, so I did not prepare by adequately fretting about this for a week prior and–more importantly–getting a Rx from my doctor for some Xanax. I'm still  50% hypochondriac, it turns out, and I am more than 20% Drama Queen.

When the study coordinator emailed at 4:45pm on the 16th to ask if I planned to come up early so I could complete paperwork and other testing prior to my 11am MRI, I didn't even bother to hit "reply".

I whipped out my cell phone and hit speed dial for her number instead.

"What do you mean the MRI is tomorrow??"

"I wondered why you never replied to my email asking if you were okay with that time."

"So, is it the same machine as last time? Because that's a short machine and I could deal with the MRI in that thing. Then even if I had Xanax, which I don't think I do, it just ends up being recreational anyhow."

"No, they replaced the MRI machine with a brand new one last year. It's much bigger."

"Bigger around, or in length?" (because in this case length DOES matter! They have to put your head in the middle of the tube to get the images, and that's not so bad in a 4 foot tube; less fun in an 8 footer.)

"Well, I don't know really. I know it's big."

So I spent that night and the next day tearing the house apart looking for a bottle containing exactly half of one Xanax. The other half of the pill was the one I took at my last MRI upon exiting the TRANSFORMS trial on January 20, 2011.

I finally found the pill the next morning, and even though I did take it, I think it just had a placebo effect. It was old and there was only half a pill. At any rate, I was  able to lay in that tube long enough for them to get pictures of my brain without freaking out and squeezing the emergency bulb, shouting "GET ME OUT OF HERE!"

Oh, you think that's funny? Heh. I've done it before.

So this is the second time around and I'm older and wiser now. Well, older anyhow.

This is Subject #0008 all over again, but I know the drill.

You're looking at version 2.0.

New Hope for ALS Patients - A Study with Gilenya

I think the scariest words a person could ever hear on this earth would be "You have ALS." I cannot begin to imagine the terror that must grip a person as their body stops responding to the brain's commands. To some extent, having multiple sclerosis, I have felt the fright of limbs that won't move or cannot feel.

Over the course of my disease I have had to use canes, a walker and even a wheelchair for brief periods of time. But, with a relapsing-remitting diagnosis, I have always had the luxury of making a nearly full recovery once the disease activity subsided between relapses.

Not so with ALS patients. Their disease marches on, unrelenting, unforgiving, robbing them of one thing after another. Taking away voluntary movement and confining the person to a prison within a body they can no longer control. The worst part is that there is no treatment to slow the slaughter of neurons.

I have always felt a strong compassion and sadness for those unfortunate enough to be diagnosed with ALS, feeling "there but for the grace of God go I." So when news of a possible treatment for the disease in Phase 2a clinical trials hit the wire this morning I could't wait to share it. The fact that it is my pride and joy, Gilenya, (TDI-132 aka: fingolimod, Gilenya™) that might make a difference in the lives of these patients leaves me smiling ear to ear.

http://www.prnewswire.com/news-releases/fda-approves-clinical-trial-of-tdi-132-gilenya-in-als-patients-190659561.html

It's my wish that amazing things are discovered and Gilenya can help lots of ALS patients live longer lives. More importantly, I wish them Quality of Life, because without that, living becomes just a prolonged wait for death.

Best of luck and Godspeed to all who enter the trial and to those who await the results.

A formal listing of the clinical trial can be found here:
http://www.als.net/ALS-Research/166/ClinicalTrials/

Information on why Gilenya might be helpful for ALS (pdf):
http://www.als.net/docs/uploads/Why_might_Gilenya_be_helpful_for_ALS.pdf

The Conversation with Big Pharma About Research Continues

I was invited by Gerry Matczak from Lilly Clinical Open Innovation to write a guest post for their blog.  They suggested around 1200 words. HA! Apparently they didn't realize how hard it is for me to get to the point. Family has learned to tune me out after the first five minutes or so, but fortunately for me, Big Pharma wants to hear what a clinical trial patient has to say. They gave me free range and let me talk until I was done. Fair warning: It ended up being over 2200 words.

Read it here on their blog:
http://portal.lillycoi.com/2013/01/08/meet-subject-0008-a-patient-perspective-on-clinical-trials/

Thanks so much to Gerry and Lilly COI for making this happen. Giving me a platform to reach those who might make a difference in the design of clinical trials is a priceless thing indeed.

Thanks also to Novartis for conducting the TRANSFORMS trial for Fingolimod (now Gilenya) and allowing me to take part in this massive study. I owe my very quality of life to you.

My Impressions of the Disruptive Innovations Conference in Boston - Part 3: The Interview

If you are just tuning in, you can read parts 1 and 2 of My Impressions of the Disruptive Innovations Conference here:

Part 1:
http://gilenya.blogspot.com/2012/09/my-impressions-of-disruptive.html

Part 2:
http://gilenya.blogspot.com/2012/09/my-impressions-of-disruptive_19.html

The evening of Day 1 of the event found me networking like crazy. I wasn't even trying but so many folks seemed to be genuinely interested in a patient's perspective on clinical trials that I got caught up in one conversation after another.  I learned a lot and was so very fascinated by every single person I met. It filled me with hope to see so many brilliant people working so hard in concert to try to effect change in an industry anchored securely in its mid-20th century fundamentals.

After the reception was over and a few of us were politely shooed out to the lobby so the ballroom could be closed, I found myself standing with Abbe Steel, VP, Patient & Physician Services for www.unitedbiosource.com and Valerie McClean, Sr. Mgr., Patient & Physician Services for www.unitedbiosource.com . We decided to go grab dinner and asked the concierge which direction we should walk to find a nice restaurant. We headed down the street which, at 9pm was bustling with activity. We talked about clinical trials, Big Pharma, and shoes. You know, girl stuff.

After deciding against Sushi and not finding many other choices we began heading back the way we came. We ended up eating at the restaurant inside the Fairmont. We spoke about a lot of fascinating stuff and before long I was lying awake in bed, staring at the ceiling, wondering how I would ever sleep since tomorrow I would be speaking to all those incredibly smart and talented people.

Next morning came and found me again sitting at the table in the back, listening to speakers share their ideas on topics I know little about. I had a moment of panic, wondering what in the world I was doing in this place and surely Craig Lipset, of Pfizer and event coordinator Valerie Bowling of www.theconferenceforum.org would realize the error of their ways in asking me to participate.

Valerie had previously emailed a list of questions that Craig was going to be asking me so I'd have a chance to prepare. Initially, upon receiving the email, I printed it out and got a pad of paper and pencil, determined to write out profound, thoughtful answers sure to impress the audience.

Then I decided not to get so uptight about it. They were asking me about ME after all... and MY BLOG. So who is the expert? Nobody knows me like me.

That's when I let go and deliberately avoided reading the questions again. I was going to make sure whatever I said was fresh, unrehearsed, and from the heart. I was given this audience of the very researchers all clinical trial patients secretly wish they had an "in" with. To stand before them and say what I thought they needed to hear.

The idea was to get up on stage and be just as surprised as the audience by whatever came out of my mouth. I didn't disappoint myself. In fact, twenty-five minutes flew by and I wasn't anywhere near done talking but due to time constraints and others needing their chance, I reluctantly gave up the mic.

But while I was onstage, seated side by side with Craig Lipset, I have to say that I felt SO comfortable and maybe only a smidgen nervous -- at first. And  didn't even need the Xanax I was wishing I had. Craig is a wonderful person who is down to earth, compassionate, friendly, warm and funny. There goes my preconceived notion of what Big Pharma execs are like. And I got the chance to tell them so.

I told them that like many other people in the general population, I always thought of Big Pharma as a money-driven, faceless, evil entity that had only their bottom line at heart. But after meeting them I was able to see that pharmaceutical companies, from the execs to the researchers themselves all seem to be surprisingly passionate about their life work, dedicating themselves to helping others achieve better quality of life. I told them that I wanted to thank them personally for what they do every day because it gave me a better life.

I also shared with them pointers about clinical trial patients and how we really ARE real people and not just numbers. We have lives to lead and if they want to recruit and retain patients they need to try not to have too much of an impact on our daily lives. Pointers such as:

1. Combine appointments so we don't have to make a bunch of trips to the trial center.
2. Provide day care during visits.
3. Reimburse for gas/meals.
4. Reimburse lost wages for those who have to take time off from work.

I said travel to the study site was an issue for me since I feared driving on I-95. I was asked if I would have felt having a nurse come to my home was acceptable or too invasive. I personally would have welcomed it -- with at least a week's notice to clean the place up first.

We talked about how I got into blogging and how clinical trial patients are finding each other and sharing notes. I told them not to fear Social Media and the Clinical Trial Patient because we are not out to ruin all your hard work by comparing notes and inadvertently unblinding ourselves. WE of all people are the ones who want to see your research be successful and have the drug we are on win approval. We have the most at stake! So my suggestion is to provide trial-specific forums with first hand factual information patients are looking for in regard to their study. But also a place to commiserate as nobody can understand a clinical trial patient as well as a fellow lab rat.

After my interview I was greeted with resounding applause (I LOVE that sound!) and I got lots of compliments as I returned to my seat. That's when I remembered the microphone and went to the sound booth to have it removed before I accidentally burped or something and ruined the illusion of sophistication I had worked so hard to pull off.

While getting de-mic'd (it's a word now) I noticed someone coming at me from the left. It was Donald Stanski, MD Global Head of Modeling & Simulation at Novartis Pharmaceuticals. He came right up and gave me the biggest bear hug! He told me how proud he was of me and that I did a great job. I can't tell you how wonderful that made me feel.

I did some more networking and was greeted with rave reviews of my talk. Many of these researchers have never before met a real live patient. I likened it to looking inside the cage and being surprised that the lab rat can speak!

I was interviewed by Aaron Fleishman of www.bbkworldwide.com and his blog post should be up tomorrow I think. I will share a link when I get it. I am going to do a reciprocal interview on his take of the conference. I just need to do some grocery shopping, a little laundry and pick the kids up from school, but it's on the agenda.

I had to catch a plane not long after that. Sort of like my carriage turning back into a pumpkin. I left with a fist full of business cards and a couple of pens, hoping to connect with as many people as I can and keep this dream of the ePatient Making an Impact on Clinical Trials and Social Media alive. I want to stay proactive and be an advocate for all clinical trial patients. I'm just not sure how to do that. One thing's for certain, I have found that when a new door opens, I'd be a fool not to go through it and see what life offers next. So far it's been an amazing journey.

Thanks so much to Craig Lipset, Pfizer, for reaching out to me initially, and to Valerie Bowling of www.theconferenceforum.org for inviting me to participate. It was an honor... and a dream come true.

My trip to St. Louis, as captured in napkins

I hadn't flown in nearly 30 years and when I flew to St. Louis for speaker training for the Gilenya Guide Network, I saved the napkin from the first leg of the flight.

I had forgotten all about my napkin collection I'd had as a child. I wonder if it would be worth anything now if I had saved it? I collected a scrapbook full of napkins from trips my parents took us on. Every flight, every restaurant. It was a cool way to remember the fun times.

But I parted with the collection at age 12 when we moved aboard the boat and never gave it another thought until 11/11/11 when I was flying from Jacksonville, FL to St. Louis, MO. I got 2 napkins with my drink (I'm sure, quite by accident) and so I scribbled the date and flight on the white part of the extra one to save as a token from my trip.

Something slowly dawned on me. The spark that was the fire. I remembered my collection from my youth suddenly and realized it would be a great way for me to chronicle my experience as a Gilenya Guide.

For those of you who don't know, there are events happening across the country where MSers and their families, friends and caregivers can go to learn all about Gilenya and ask questions of the doctor who gives the presentation. Many of these events will feature one of the real life patients who have been on Gilenya and have been invited to travel and share their stories. We are trying to spread the message of empowerment. "Take control of your own MS and be your own advocate." is pretty much what I tell people.

So this is going to be quite an adventure for me. And I'm going to bring you along one napkin at a time.

I will keep blogging my usual stuff, but when I go on a trip I'll be sure to post my napkin pics. :)

Here are the ones I have so far -- in chronological order.

I was terrified. My poor sister, who accompanied me, probably still has bruises on her forearm from my white-knuckled grip.

Second flight, I was a wee bit more relaxed but not totally. I did get to see that St. Louis looked lovely in her sequined evening gown and jewels -- or so it appeared from the night sky.

At introductions I was so nervous all I could hear was my own heart pounding in my ears. I told them I am so shy about public speaking that I can't even talk to my own family at Thanksgiving dinner. I finally got going, describing my MS journey and by the end I was recounting how I used to have to use canes or a walker. But then I started crying. Everyone clapped. Someone brought me napkins to dry my eyes. Naturally, I kept one.

Sunday night we were done with training but couldn't get a flight out early enough so we spent an extra night. We wanted some of that famous BBQ we'd heard so much about. We checked to see if Pappy's was open (our driver had recommended it) but alas it closed at 4pm. Someone else said the Brewhouse, located in the hotel, had awesome BBQ. This wasn't an exaggeration. We had the sampler platter. mmmmm

Note: Susan K. we tried to find you when we found out Pappy's was closed but apparently I never got your number. Duh. Sorry!

Monday morning I was back to having pre-flight jitters. I had already learned that walking through airports with an overstuffed carry-on and leaning to compensate for it while using a cane is awkward and tiring. I never have to use my cane day-to-day but decided to take it for the extra walking involved in travel.

A Delta ticket agent saw me with the cane and asked if I wanted to pre-board and she offered me a wheelchair ride down the jetway (see Anne? I remembered the word. :P) She ran me down the jetway (actually saying "vroom" as we took off with the chair). Then we got to the little ramp where the jetway telescopes and she said "little bump!" right before the wheels stopped dead and suddenly I flew through the air. I landed on my cane, crumpled in a heap. She freaked out and helped me up saying I must have been dragging my feet. Uh, no, sorry. Totally your fault, not mine. I now have a huge bruise, but all in all it was no big deal. 

The flight was otherwise beautiful and I was able to relax and channel my inner child who used to love flying and collected napkins with glee.

So that's how this new chapter of my life is shaping up so far.

More napkins to come as my first speaking engagement is scheduled for Athens, GA on 1/2/11. If you're in the area, come on out!