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!

#drugprices : The High Cost of Quality of Life and How You Can Effect Change #socialmedia #activism

If you suffer from multiple sclerosis (MS), unless you have lived in a cave since 1993 when Betaseron, the first FDA approved disease modifying drug (DMD) came on the market, you are well aware that the cost of these drugs is astronomical. It seems morally wrong to put a outrageous price tag on a substance–capable of improving quality of life for those who suffer from this disease–only because people are desperate to get it.

Drug companies, when asked to defend their pricing strategies, quickly point out that the cost of research and development (R&D) is exorbitant, and only a small percentage of drugs ever win FDA approval after decades-long trials. If a drug wins that distinction it must pay for not only its own R&D costs, but for those that failed as well.

But there's much more that factors into how these drugs are priced.


I had the honor of speaking with one of the country's foremost experts on the topic of drug pricing, Dr. Kenneth Kaitin, a professor at Tufts University School of Medicine in Cambridge, Mass. We spoke for nearly thirty minutes on the topic of drug prices, how they are achieved, and the emerging power of social media to effect change.

He spoke to me about value, competition, patent life, and more. But he also spoke at great length about how patient groups, physician groups, and individuals are increasingly effecting change, enabled by the power of social media.

The interview was part of the research I did for the two part series of articles I wrote for Healthline.com:

Part 1: Should Multiple Sclerosis Drugs Cost $62,000 per Year?
Part 2: Voices For Change: How You Can Impact MS Drug Pricing


In short, the pharmaceutical industry is one that operates like any other. They depend on their cash cows–in this case the MS drugs–to be the stable, revenue-producing portion of their portfolio that allows them to invest in riskier, cutting-edge research that often yields astounding breakthroughs in medicine. Like it or not, it's the system we have.

To be certain, all drug companies now offer generous patient assistance programs, so the majority of those who want them have access to the DMDs.

If you need to be on a DMD but think they are cost prohibitive, be sure to ask your neurologist about the programs available to assist in covering the cost.

After writing the series I felt uplifted, empowered, and motivated to use my online presence to try and inspire others. There are so many people suffering from MS out there who are sitting at home feeling powerless, frustrated and desperate about their situation. They feel hopeless to change the course of their disease, or they can't afford health care to try.

In this age of social media, however, activism is only a keyboard away. If you want to make a difference, start by joining the National Multiple Sclerosis Society, encourage those at a local support group to do the same. Get involved in speaking out. Blog your hopes and dreams for the future of healthcare, send your congressperson or senator an email about your situation and your desire for affordable medicines and healthcare. Take a stance and use your voice.

Every little bit helps. I'm going to use my voice to educate others on personal empowerment and how to effect change.

Now go do something positive and never forget: One person CAN make a difference.

#livingwithMS - World MS Day 2013 - Getting Their Tweet On

I recall when I was first diagnosed with MS. I spent several years with my back turned toward the truth. I avoided the local MS group as they seemed to be sad and depressing. Lacking hope. I was so fearful of my own uncertain future that part of me just refused to believe I even had MS.

It was easier to deny than accept. Facing the truth would mean accepting the fact that I have an incurable, unpredictable, potentially disabling disease.

But somewhere along my path, well after my entrance into the TRANSFORMS clinical trial, and even after starting this blog, I became comfortable with facing my disease head on.

I believe my experience with Novartis' Go Program and becoming a patient speaker did more for me that I gave back to them. I learned to accept that I do have MS, that it's not the end of the world, and that with my voice I can reach out and make a difference to others who have MS.

It wasn't until I overcame my fear of public speaking that I came out of my shell and embraced, albeit reluctantly, health activism. But with the single act of accepting my own MS, for better or worse, I have freed myself and realized a passion I didn't think possible.

When opportunity knocked, I went through the door. So that is how my own personal MS motto came about. "Just keep putting one foot in front of the other." Simple, but there's a lot to be said for a pragmatic approach.

When I am speaking or writing on the topic of MS or my experience as a clinical trial patient, I have a sense of purpose. You can go a lifetime without ever knowing that feeling, but I have been blessed.

Tomorrow is World MS Day 2013, when the whole world joins together to recognize–and spread awareness of–multiple sclerosis.

I have been given the opportunity to help raise awareness of MS yet again! www.healthline.com has invited me to participate in a Tweet Chat on the topic of World MS Day 2013. The event will take place live on Twitter at 11 a.m. ET.

I'm inviting everyone to join in or at least follow along by using hashtag #livingwithMS. It should be an awesome event! I will have the honor of tweeting alongside, Samantha Schech, a Client Service Consultant with the Multiple Sclerosis Association of America (MSAA); Ayesha Ali, Campaigns Manager at MSIF; and Ceri Angood, Director of Programs at MSIF.

Won't you join us?

======================
UPDATE: Today's article on Healthline.com just published. Read about the "nuts and bolts of what goes into the making of World MS Day, and find out what comes from all that awareness and fundraising:
http://www.healthline.com/health-news/ms-world-ms-day-raises-awareness-and-funds-052813

Summertime - Too Hot To Handle

I'm talking about heat sensitivity and how it affects MS, not me in a bikini–I'm about 30 years past that expiration date.

Read my latest article on the subject over at www.Healthline.com. To get my own personal view on the matter, keep reading here first...

It was early on in my MS career (because that's how I think of it now, due to the opportunities which have come my way since diagnosis) that I had my battle with summer.

Summer won. That was the year the family drove from Florida to Georgia to see relatives who lived in the middle of Death Valley. Yeah, I know my geography is all wrong, but you could never have convinced me of that.

We were outside in the middle of July with not a single tree in sight. Sitting by a pool and broiling in sunshine. The mercury was pegging 100 degrees. Not knowing there would be swimming involved, I wasn't dressed for the occasion. I was wearing jeans and a T-shirt and sitting at the little round glass table with everyone else. I don't even recall an umbrella. I just remember the unbearable heat.

It grew hotter and hotter, but I never broke a sweat. That reminds me of the back-handed compliment/joke my dad used to tell, "You don't sweat much for a fat girl." Had I been able to sweat, I may have cooled off, but instead the heat just drove my core temperature through the roof.

I got up and staggered to the car, parked about twenty feet away and crawled inside to start up the A/C. Even with it blasting in my face, it seemed I couldn't cool down. By this time both legs were numb and weak. I was experiencing a fatigue like none before. I felt like I weighed a thousand pounds and it took everything I had to even lift my head off the back of the seat to turn and call out the window for someone to help.

That was my first–and most dramatic–encounter with heat sensitivity. After that weekend, when we returned to Florida, I ended up being admitted to the hospital for three days of IV Solumedrol to halt a new MS attack. My neuro at the time claimed it was only coincidental that I had such an intense reaction to the heat and then had a relapse. I've always wondered if maybe it wasn't the reason.

So this week's article about heat sensitivity is something I know most of us with MS are familiar with. If you have MS and don't have an issue with the heat, I'm assuming you are reading this at either the north or south pole, in which case cold is probably more of an issue.

If you are anywhere in between, be sure to read along for some great pointers and links to tools that could make summertime more bearable for you.

Because they don't have room for all the wonderful content I would love to share with you over at Healthline.com, I am going to continue blogging my "leftovers" so you can get a veritable  smorgasbord of useful info.

This Week's Leftovers (in no particular order)...
In an interview with Anne P., who is from Georgia and has had MS for 14 years now, we learn about her own experience with the heat. She also has quite a few good tips on how to deal with it.

"[I use a] cooling towel. I love the Frogg Toggs towels and neck wraps - they are amazing. Other than that I always have ice water at the ready and do my level best not to be farther than a comfortable walk to an air conditioned space - even if it's my car!," Anne advises, "Don't push it. Stop, rest and cool down a lot, even if you think you don't need to. It is better to be safe than sorry!"


When asked how heat sensitivity has made a difference in her life, Anne says "My days of pool parties and outdoor festivals are over. Really, what I miss the absolute most is being able to volunteer at booths for a local charity that I love."

Thanks, Anne!

Corrina Steiger, President of the North Florida Chapter of the NMSS provided a lot of valuable tips on dealing with the heat. She also mentioned that the NMSS has resources to help people in need of assistance obtaining cooling vests or paying high cooling bills. "For more information on how we can help, contact the Society in your area by calling 800-344-4867.”

Thanks, Corrina!

The interview I had with Dr. Scott Silliman was conducted over the phone and I did my best to type and listen and comprehend all at once, but I probably failed him miserably. He had so much great info to share.

"I usually see [heat sensitivity] most in people with spinal cord MS and in those with optic neuritis. I see it less in patients with a cerebral form of MS." Silliman said, "This is because there is less redundancy of nerve pathways in the spinal cord and also in the optic nerve, so there is less ability to compensate for nerves that aren’t working.”


It was an honor to have the pleasure of interviewing Dr. Silliman, as he is my own personal neurologist and was the lead investigator of the TRANSFORMS trial in which I participated.


Thanks, Dr. Silliman!

Kim Gillespie, creator of the TaTa Coolerz, has a different approach with how to combat the heat, for women anyway. She was away on a camping trip over Memorial Day Weekend (happy anniversary, Kim) when she got the idea for a cooling device that could be discreetly worn to cool you off without everyone aware you are suffering. The TaTa Coolerz are worn tucked inside a woman's bra, providing cool comfort to a sensitive area while bringing down your core temperature.

"They go right in the freezer, then you take them out and squish them up to get them malleable. Then, when you tuck them in your bra, they conform to your shape. We've had them last as long as two hours, fifteen minutes in the Florida sun."

"They are designed after high-end fashion push-up bras, and they are durable and reusable," said Gillespie. From her facebook page, "For the entire month of May TaTa Coolerz is honoring Mom. Please use code: Mom2013 to receive a 20% discount on your purchase."

Thanks Kim, for giving us another alternative to fighting this intolerable heat!

Summer doesn't have to be dreaded and unbearable. We can once again venture back out into nature to take part in fun activities like pool parties or picnics as long as we approach it with common sense and a few tools.

That's it for this week.


If I don't see you before, I'll see you next week. Until then, try to stay cool.

The Halfway Mark

Last Thursday was the halfway mark in my clinical trial and for some reason I've been so melancholy about it that I didn't even want to blog it. I just don't want it to end and there's always the "what if" about whether it will get approval or not. I can't imagine that it won't but I fear if I don't hold my breath and cross my fingers, knock on wood and any other superstitious thing I can think of doing, I might jinx it or something.

Anyhow... the checkup went smoothly. My sister drove me again because of having to have my eyes dilated for the eye exam and OCT. My first appointment was at 9 am for the Pulmonary Function Test, and the last appointment of the day was going to be the OCT at 1 pm. I don't know why I expected it to all go smoothly and as scheduled. It never does.

I'm still getting over this head cold that decided to make a home in my chest. It only bothers me at night and first thing in the morning with a gagging cough that threatens to push my lungs out my mouth. I have started sleeping in my lazy boy all night just so I'm somewhat inclined. If I lay flat I cough nonstop. I was worried that my breathing test would be skewed because of this, so I made sure I told the guy doing the test.

He's the same guy who always does the test and after he did the first part of it (where I'm sitting in the plexiglas box) he said "you actually did better this time than last time since you had a cold last time."

Geeze! I'd forgotten that! Anyhow, he said that my lungs were normal just like they were last time.

Then it was off to go back across 4 lanes of traffic to get from the hospital to the Towers. For the last 7 visits I have walked there, risking life and limb. On this occasion however, the tester guy asks if we knew about the Orange Shuttle. Huh?? All this time there's been a shuttle I didn't know about?

He walks us out the back entrance to the hospital to an area with an orange sign that says "Orange Shuttle Stop". He leaves us there with the warning "Don't take the blue one because it goes all over town. The orange one goes from here to the Pavilion, to the towers."

A few minutes later, here comes a big white bus (he neglected to mention WHITE) and we just stood there as it stopped. No other people were at the stop but my sister and me. We tried to wave the lady driving the bus on, but she just pulled up farther and opened the door. "What are you waiting for?" she asks. "The Orange shuttle, we reply in unison."

"This IS the Orange Shuttle, get on."

We say "no it's not, it's white." (Like because she's inside, we are compelled to describe the outside to her so she has a clue). She rolls her eyes and tells us she keeps telling them she needs something orange to stick in the window so people aren't so confused. Turns out they have 4 orange shuttles and 3 of them are white. Go figure. We get on.

Next stop is the research department to see my trial nurse for the blood work, urine test, MSFC, EKG, and exam with Dr. Kantor.

The MSFC, I'd forgotten all about. It's the test with the dreaded Numbers Guy. See this post for the horrors of the first MSFC exam. The numbers guy stumped me again and I was left sitting and listening to him rattle off numbers for 3 in a row somewhere in the middle. It was those 7's and 9's again. You have to add 2 numbers and say the result and wait for him to say the next number. You add that to the last number he said while trying to forget the previous total which you just said out loud. Sound confusing? Try playing the game. Just as last time, the practice test went perfectly. I waited for the real thing to screw up.

Then, when that was over, I did the peg test and it seemed a little harder this time. My hands just don't want to behave themselves. Either that or the pegs shrunk since the first time. I actually had one peg stick to my sweaty fingers as I went to drop it in the bowl. It release when I had my hand, mid-swing, over the table. I lost precious seconds scrambling for it and nearly knocking it on the floor. If this is a test of how clumsy one can be, does that mean I passed?

Speed walking came next. I was so excited that, between last time I was tested and this time, I have actually retaught myself to run, I just had to ask...

"Is it okay if I run instead of walk?"

(laughter)

"no really."

(more laughter, then a pause)

"you're serious?"

"dead."

"No, honey, it's a walking test. Just walk as fast as you possibly can."

So I walked the way the kids at school walk when they know they aren't allowed to run but can't help pushing the rule a bit by speed gliding. I'm sure I did way better this time than last.

Next, the blood draw. Two little vials rested next to the rubber tourniquet, alcohol wipe and pokey stick. I tried to go to my Zen place and not think about it. I have small veins that wiggle and roll and hide when someone tries to prick them. Last time it took the one lady six tries before she went and got Geri (a name I can remember, yes!) who is the Master Sticker. She got in right on the first try and told me which vein and the angle it lies at in the left elbow area for future reference.

This time I say "well, if all else fails, you can go get Geri."

"Um, Geri got another job."

"Crap! But no, that's fine, you'll do just fine, I'm sure! No offense or anything. By the way, the vein's right here, running at this angle."

Thank God she left me with that tidbit of info before moving on to bigger and better opportunities. My nurse stuck me good the first time. But, right before she did, she said "Oh, I forgot to get the Kit out." She brings out this box and opens it to expose another several dozen vials (actually only 4 more, but once you've reached 6 vials they might as well get the last couple of drops you have left in you while they're at it). I nearly fainted, but I stayed strong.

I still needed to get my EKG, see the doctor, and fill out the PRIMUS paperwork. (That's a questionnaire about how MS affects your life). But there was no time. I was running late for my eye exam. She said "go to your appointment then come back for the rest of this stuff." So I did.

The eye exam went great. No changes to my vision and I left there all blurry eyed, gripping my sister's arm and feeling like Mr. Magoo. We went to the truck and had the lunch we packed while waiting for time to go have the OCT.

I love going for the OCT after seeing the eye doc because my eyes are already dilated and they bump me to the head of the line while the other poor saps are waiting for their drops to start working.

The OCT went well. I kind of enjoy watching the spirograph-like designs and the challenge of not blinking. I never have the urge to blink until someone tells me not to. Kind of like "Don't swallow." when you are having a C-spine MRI. All you can think about is to wonder if anyone every drowned in their own saliva.

We ended up the visit back at Research where I got the EKG and they scheduled a future appointment with the doc because he wasn't going to be able to squeeze me in that day.

The EKG went well. I heard the nurse and one of the doctors looking over my printout.

"Look at this."

"Wow!"

(my ears perk up and my heart starts pounding and palms sweating in anticipation of bad news.)

"Have you ever seen such a perfect EKG?!"

"Can't say as I have. That's a beauty. Just look at that spike."

(huh?)

That was my excitement for the day and lucky I wasn't still strapped to the machine or they might have changed their tune.

I was loaded down with my 3 boxes of new shots and my 3 bottles of pills and sent on my merry way.

Everything's looking good so far. Keeping my fingers crossed that the second half of this study is as successful as the first. I'd love to say I could barely remember my last MS attack -- and not have it be from cognitive dysfunction. :-)

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