Friday, December 23, 2011

FTY720 normalizes hyperglycemia

Yet another exciting new use of Fingolimod! Hope this makes it to approval. Both of my brothers have Type 2 Diabetes. Wouldn't it be awesome if FTY720 could cure them?

Fascinating read...


FTY720 normalizes hyperglycemia by stimulating β-cell in-vivo regeneration in db/db mice through the regulation of cyclin D3 and p57KIP2:

'via Blog this'

Wednesday, December 14, 2011

Multiple Sclerosis Research: Fingolimod death

Multiple Sclerosis Research: Fingolimod death:

'via Blog this'

Unsettling news to say the least! I will be very interested to know the outcome of the investigation.

Sunday, December 4, 2011

My first real public speaking gig is finally over!

As a lot of you know, I have been selected to become a Gilenya Guide. What this means is that I have been given the most awesome opportunity imaginable -- to share my MS story with other MSers who come out to presentations about the drug. I get to be the living, breathing example of what it means to be on this therapy and how it's worked for me.

I won't get into the details of the presentation; if you want to find out what it's all about, check to see if there's an event in your area by going here:
http://www.gilenya.com/info/support/upcoming-events.jsp
There are new events being added all the time. If you don't see one close to you, perhaps you can contact your local MS group and have them look into setting one up. You can learn all you could possibly want to know about Gilenya from one of these events and get some one on one face time with a knowledgeable neuro.

Anyhow, I had gone through speaker training to learn how to talk to groups of people without melting into a puddle of nerves. Well, that's what the training was for theoretically, but I was still a ball of electrical energy. So much so that I had to wait until after speaking to even eat the nice meal they provided.

My sister went along for the trip and here are pics of us either near or at the little French restaurant where the event took place -- prior to the talk. This is in Athens, GA, home of the Bulldogs. We were oh so careful not to mention the Florida Gators whose home is  an hour or so from our own.

Just up the street from the restaurant. It was a beautiful day in Athens, GA! Here's my sister Lorraine looking as beautiful and radiant as ever. She was the cheerful cheerleader the whole time. Could NOT have done this without you, sis! ILYWAMH, ES.

Outside the restaurant. We got there early so we hung around outside to let the staff get the tables all set up.

The waiting, accompanied by nervous pacing and trips to the ladies room, was the hardest part.

No turning back. We're here. Let's do this!

So, people start showing up and I recognize Dr. Snyder from his photo that I saw when I googled him the night before. I walked up and introduced myself. We spoke about Anne, who is the other guide he had been scheduled to present with the night before. Their event got canceled due to lack of audience.

Anne is one of my long-time faithful blog readers who got into the Freedoms II trial after seeing that a hypochondriac like me could do the TRANSFORMS trial and live to tell. (according to her) Well, she's the one who brought the Guide Network to my attention and would not relent until I screamed "UNCLE" and got on board. She was in a previous training group and now has done something like 14 events.

Anyhow, after talking with the doctor about the meeting the night before, he mentioned something about her coming to my event. I was confused. Only reason I would be doing this one (which is a couple hours from her home) was because she was scheduled to be in Louisiana on another talking trip. The doctor was mistaken. I told him so.

He just smiled and said "I believe that got canceled." He knew he'd spilled the beans, but so what? It was a matter of just a few minutes in advance... long enough for me to whip out my cell phone, hit Anne's cell number and demand "WHERE ARE YOU?" when she answered. "Trying to find the damn restaurant!" was her reply.

Moments later she walked through the door and I tried my best to bowl her over with a big hug. It was awesome. Her nephew goes to college in Athens and he met us there, too. A good time was had by all. And I think it's safe to say I have met someone my own age and I am bigger than they are. PHHHHHT! Take that!

Anne's the littler one on the left. I have the head twice her size, I see. Poor mom.


Here I am introducing myself and telling everyone that it's my first time so go easy on me. LOL I set my notes down shortly thereafter and never referred to them again, I don't think.

Don't I look so genuine?

Two more pics of Anne and I. The last one is my favorite and captures her essence so well. :P


The trip was fantastic, the presentation was informative, the audience was warm and receptive.

I hope those who came out to attend left having learned something. If nothing else, they learned I cannot for the life of me tell the part about what Gilenya means to me without crying.

From the time I first saw my new neuro at an MS meeting talking about all the exciting clinical trials coming up, through being part of the most awesome clinical trial ever for MS, and now to the part about traveling around and sharing my story, I can't get over what it all has meant to me.

Everyone's experience is different, I know, but mine has been an amazing journey.

If your therapy you are on now is not working for you, be sure to talk to your doctor, be your own advocate, and don't be afraid to try something new. I did and I am so thankful...

PS: Anne, you didn't think I wouldn't blog you, did you?? Honestly? LOL

BTW, folks, Anne is another MS blogger and you can find her gems of wisdom over at

Tuesday, November 29, 2011

When do you know if MS is affecting you mentally?

I'm just curious. I've always been kind of scatterbrained but it seems as I age, (or is it really the MS?), I find that I can be presented with a situation and instantly read it all wrong before I'm clued in and figure out what I'm seeing.

Example: Pulling in to the bank parking lot, heading for the drive-thru lane. On my left is the bank building surrounded by landscaping. On my right is the parking area. From the right comes a short, squat yellow vehicle with no top, yellow/orange metal framework, 4 big tires and someone behind the wheel.

Immediately I see this as someone in a go-cart heading for the drive-thru lane. Just as I was about to open my mouth and give away the fact that I'm clueless by saying "Hey, look at that! I've never seen a go-cart go through the drive-thru before!" I catch myself.

Within seconds he finishes crossing the parking lot and is either doing donuts in the grass around the building or what I thought was a go-cart is actually a lawn mower.

It seems like my perception of things, at least for the first few (sometimes critical) seconds can be way off from reality.

It disturbs me sometimes. Is it MS, or is it age? Or is it just in my genes? Mom, who was sitting beside me, thought it looked like a go-cart, too.

I just wonder... how do we know if MS is affecting us mentally? I know about the "crying when you're supposed to laugh" and vice-versa stuff, but I'm not really sure about the subtleties of perception.

Or maybe it's just me and that I'm clueless in a perfectly fine, healthy, normal way. :)

Sunday, November 20, 2011

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!

Friday, November 18, 2011

Come learn about Gilenya!

As a lot of you know I just went through training to become a Gilenya Guide (patient speaker). This means I will be traveling around telling my MS story and Gilenya experience at different events where Gilenya is presented. There will be a physician who gives a slide presentation to groups of MSers and their family, friends and caregivers along with a real live patient on Gilenya (me) and a nurse provided by Novartis to moderate the meetings. Question and answer sessions follow. This is a great way to get informed about this new drug and be able to have face time with a doctor who will be able to answer all your questions.

I just got my first speaking event! It will be in Athens, Georgia on December 2, 2011 at  Etienne Brasserie. It will begin at 11 a.m.

I am so excited and if you want to come out and get informed, I'd love to see you there!

Just so you know, I wear many "hats" in my life and my blog is totally separate from this speaking experience with Novartis, so if you do come, this blog won't be the topic -- nor will it even be mentioned. It's not the point of the event.

I'm just so happy to be able to share with a greater audience this way and reach out to MSers who might be struggling with their current therapies or may be feeling like they have reached their wit's end. I just want to let you know that there IS hope and things CAN get better. They sure did for me.

While everyone's experience is different, granted, and Gilenya may not work for you, you have to take charge and advocate for yourself since it's your life you're living. Know what I mean? There's nobody who knows your struggles better than you do yourself. So no matter what you choose to do, keep having that dialog with your doctor and keep trying until you find something that works for you.

Trust me. Read my blog. Been there, done that.

Friday, December 2nd, 2011, 11:00 AM, ET
An Overview of Treatment with GILENYA
Etienne Brasserie - Athens, GA
Presented by Thomas Snyder, MD

If you aren't near Athens, Georgia, there are events going on all over the country. You can find an event in your area by visitng the Gilenya website here:  http://www.gilenya.com/info/support/upcoming-events.jsp

In a nutshell:  Just don't give up.

{{{ Hugs to all of you }}}

because MS SUCKS!

Wednesday, November 16, 2011

Is Empathy in Our Genes? - Health News - Health.com

Is Empathy in Our Genes? - Health News - Health.com

A very interesting read. Thought I'd pass this along as I need more time to recover from the weekend and you need something to read in the meantime. I sense that and can feel for you...because I'm empathetic. :)

Monday, November 14, 2011

The weekend of a lifetime!



What an amazing time I had in St. Louis. Loved seeing the sights and meeting so many inspiring, wonderful people. You know who you are. If you are here reading this and you were in St. Louis this weekend, YOU are the wonderful, amazing, inspirational, uplifting person I am talking about. ALL of you.

I'm too completely exhausted both physically and emotionally to say anything more tonight, and I promised there were certain things I wouldn't blog about, but there are tons of anecdotal insights I'd like to share. Nothing that will infringe on stuff that's not to be shared though. :)

Anyhow, if you were in St. Louis and would like to stay in touch, be sure to leave a comment on this post with a way to contact you. I neglected to get about 1/2 of your phone numbers and was disappointed to see that certain folks weren't in there. If you do leave a comment rest assured I will not publish them and I will respond via email.

It was just too great an experience not to keep in touch.

And if you weren't there and you have no idea what I am talking about, I think it's safe to say we were all a group of patients attending training  to become patient speakers for Gilenya. Sorry, but I'm not going to go into detail about what that entailed but I may touch base on some funny tidbits to share with you of my travels.

I'll leave you with one.

Friday, 11/11/11, was the first time in roughly 30 years that I flew. The second leg of the trip was from Atlanta to St. Louis. I had a center seat with two big burly guys on either side. The guy on my left was reading Hemingway's "For Whom The Bell Tolls" and was a couple dozen pages from the end.

The guy on my right was fidgety and listening to his ipod and wearing corduroy pants.

It was all I could do not to lean to my left and say "It tolls for thee," or lean to my right and ask "are you wearing those in honor of 11/11/11?"

Ok, maybe not the greatest jokes, but I was paralyzed with fear so forgive me. When we touched down and bounced a little, I was muffling a scream. The book reader guy was yawning and I said "REALLY?? You're yawning and I'm trying not to scream???" And he just chuckled.

On the way home, somewhere between Atlanta and Jacksonville, I found myself either relaxed enough or exhausted enough to finally yawn a few times myself.

And with that I leave you. I'm going to go hibernate for about a week. And think about all the fun we had.

Wednesday, November 9, 2011

Visualization -- Use it for good, not bad

One of the qualities any hypochodriac who's worth their salt possesses is the ability to vividly visualize any given situation in the near or distant future and predict a negative outcome. I have always been good at this, having learned from Master Of The Hypochondriacal Experts Reknown (henceforth referred to as MOTHER). She is not only a medical worrier, but has widespread fears in general, perpetuated by a vivid imagination that chooses to visualize the inevitable negative outcome of any given situation.

For instance, if it's cloudy out and I'm about to walk out the door, she suggests an umbrella and tells me to leave 15 minutes earlier than planned. According to MOTHER, the clouds mean that a nasty storm is about to unleash it's wrath on me simply because I choose to leave at that moment. This will be a storm that blindsides the weather guy who never knew to warn us. It will bring trees crashing down on the roadways, cause visibility to be negative 4 feet (so I can't see anything but the back seat when looking out the front windshield), and I will not reach my destination without facing many perils. Why, that storm could fill the drainage system and cause  alligators to rise up out of the swamps to nip at our heels if we step outside. Likewise we shall be accosted by snakes.

All this goes on in her head because of the "What-If" mentality. This same visualization could be put to better use envisioning a positive outcome, but if something does go horribly wrong we wouldn't be prepared for it. Instead, both MOTHER and I choose to pre-live every horrible situation in life and fret about those things which are out of our control rather than face things the way normal people do. I imagine normal people leave the house on a cloudy day never knowing they are about to be crushed by a tree in a blinding rain storm. If only they had taken that umbrella.

There is really no way to stop this ingrained internal conversation. It's in my DNA. It's that voice inside my head that narrates my daydreams. It's the voice that argues the what-ifs with my somewhat shyer, less assertive, newly acquired Voice of Reason.

This Voice of Reason is a new voice that I have found. It has lain dormant in my soul, letting the Voice of Irrationality who has had the podium for lo these many years always take center stage.

But I'm encouraging this Voice of Reason. Trying to let myself know that it's not so bad to think positive.

Case in point: I have suddenly found myself about to fly on a commercial airline for the first time in nearly thirty years. I never considered that I would ever be flying again as I had no plans to go anywhere and did not anticipate that I might win a trip or something (I was too busy, preoccupied with negative outcomes to entertain anything foreign like that).

So when I was invited to become part of the Gilenya Guide Network, I had to come to terms with the idea that this is going to mean flying. Not once, not twice, but on a regular basis for the next year. I will be a patient speaker at  MS meetings where Gilenya is being presented. I will be the voice of the real patient who has been on the drug and lived to tell. I can show others with MS who might be considering the drug that look! I haven't grown a third eye or gills from taking it.

But this necessitates flying. My first flight is going to be this Friday as I head off to Speaker Training taking place in St. Louis, MO. for the weekend.

I have known about this for a couple months and have dealt with it in many ways over that time. At first, knowing it was a ways off in the future, I placed it on the back burner where it was a simmering worry that never really took shape but just sat there like a bubbly black mess in a sticky pot that sometimes gave off a foul odor that would waft up into my conscious thoughts.

But as the date has come closer, that pot has shifted place to be on the front burner. I have to deal with my apparent fear of (or at least strong anxiety about) flying.

It's crazy. I was practically raised at a small airport until I was 12. My folks owned a 1/4 share of a Cessna 182. Dad and Mom (yes the same one who is referred to as MOTHER in this post) both earned their private pilot licenses in that plane. We went up flying a LOT.  I can remember one of the most beautiful sights from my childhood was in that plane, looking out the window at the hills of western New York as the autumn leaves were ablaze in red, yellow, orange and gold below me. It was nothing less than spectacular.

But I was 12. I hadn't yet developed my inner hypochondriacal worry wart. I hadn't given voice to my innermost irrational thoughts. I was unencumbered by that demon. So unencumbered was I, that I was able to go up in a T-6 WWII training plane owned and flown by my parents' friend, Ralph Twombly, and do barrel rolls, backwards loops, cork screws and stalls while laughing gleefully at the ground beneath my head and the blue sky at my feet. I felt more alive at 12 years old than at most other times of my entire adult life.

Here's a picture of a T-6 trainer -- not the exact one I flew in, but the only difference was the color. The one I flew in was red and white.



So here I am, certainly no stranger to the air, worrying about every little thing. Until yesterday.

Yesterday something snapped.

I was picking my son up from his return from a school field trip out of town, and we had to pass by the local airport. It was sunset and the sky was golden.

Here's one I snapped while sitting in the parking lot waiting for his bus to come in.



As we passed the airport I caught a glimpse of a Cessna much like Dad's that was backlit by the sunset. I suddenly remembered how excited I always got right before we flew. It was exhilaration, not anxiety, that I remember feeling.

And I want to feel that again. I took that moment to be a sign. A sign that I need to start listening to the child within that remembers life before worry. Anticipation without fear. A feeling that anything is possible and that it's okay to pre-live a happy outcome.

So I say to all you fellow worriers out there, and you know who you are: Next time you catch yourself imaging the most awful of horrendous tragedies in your head, give equal time to the What-If thought that maybe something exciting and happy and pleasant awaits you. You never know, you just might be surprised.

It's just starting to dawn on me that maybe the inner voice that speaks to you actually guides you to your destiny. And depending on what tone that voice is using, your outcome can either be positive or negative. And if I had let that worrier voice freeze me in my tracks, well, then there's a road, a path, I would never know. Just maybe there's something great waiting at the end. I can't let that Voice of Irrationality hold me back. Of all the terrible outcomes I have pre-lived in my imagination, not one of them have ever come to pass.

This will be the last post before I go, but I'll be back to tell you all about my trip. There's going to be plenty to blog for sure!


Friday, November 4, 2011

Francie: the answer is yes

This is just a post to reply to a personal message I received in the form of a comment. The comment was not meant to be published but the question needed to be answered. So, Francie, the answer is yes.

I promise I'll be on here soon to write something witty and entertaining. Possibly informative, but no promises. Life has just been coming at me full throttle lately. When I get a chance to breathe, you'll be the first to know.

Saturday, October 22, 2011

News from ECTRIMS 2011

One of the biggest annual events for information sharing in the world of multiple sclerosis research and treatment is the ECTRIMS meeting going on now in Amsterdam, The Netherlands.

It fills me full of excitement and hope for the future of MS patients the world over!

Here is a video from my former neurologist and lead investigator who recruited me into the TRANSFORMS clinical trial for Fingolimod (Gilenya). He is attending the ECTRIMS 2011 Conference.



You can also find posts on Facebook by Dr. Kantor here:
Multiple Sclerosis Migraine (Daniel Kantor)
Follow him on twitter.

Here are just a few links to news coming out of ECTRIMS this year:

 Advances in Using Stem Cells as a Treatment for MS
by Julie Stachowiak, PhD
The most progress in looking at the effect of stem cells in humans with MS (as opposed to experimental mice models) has been made on hematopoietic stem cells. This research was presented by Mark Freedman, MD from the Ottawa Hospital Research Institute at ECTRIMS 2011.

Hematopoietic stem cells (HSC) are taken from adult bone marrow and blood. They can also come from umbilical cord blood. They are multipotent, meaning they can turn into only a small number of different cell types. HSC are quite rare, making up less than .1% of bone marrow cells. These cells act as the foundation for the immune response.
[Click here to read the entire blog post.]

Acorda Therapeutics Announces Data on AMPYRA® Presented at 5th Joint Triennial Congress of ECTRIMS and ACTRIMS
“Analysis of walking speed data from the extension studies showed that people who responded to AMPYRA had sustained improvement compared to non-responders for up to five years on treatment. Just as importantly, safety data from the extension studies and from one year of real-world use showed that the long-term safety profile of AMPYRA was consistent with that observed in clinical trials, with no new safety signals emerging.” --  Ron Cohen, M.D., Acorda’s president and CEO.
Read more: http://www.bradenton.com/2011/10/21/3583350/acorda-therapeutics-announces.html#ixzz1bVakIWnL


BG-12 Data Impress in Multiple Sclerosis

October 21, 2011 (Amsterdam, the Netherlands) — A phase 3 study of oral BG-12 (dimethyl fumarate, Biogen Idec) in relapsing-remitting multiple sclerosis (MS) found that the drug reduced by roughly half the proportion of patients who relapsed at 2 years compared with placebo.
The findings, from the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial were released today here at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS). The study was supported by Biogen Idec.
"We conclude that these results may provide a therapeutic option for patients with relapsing MS, with robust efficacy, a good tolerability, and excellent safety profile for this oral drug," study presenter Ralf Gold, MD, professor and chair, Department of Neurology, St. Josef-Hospital/Ruhr-University, Bochum, Germany, told attendees here.
Ocrelizumab Benefits in MS Maintained to 96 Weeks
There is increasing evidence that B-cells play a role in the pathogenesis of MS through antibody-dependent and antibody-independent mechanisms, the authors note. Rituximab, an anti-CD20 monoclonal antibody that selectively reduces CD20-positive B-cells, showed "proof of concept" efficacy in MS in phase 1 and 2 investigations, they say. Ocrelizumab is a recombinant humanized version of rituximab meant to provide some advantages in potency, tolerability, and safety for the long term.[Click here to read entire article]

INVESTIGATIONAL LAQUINIMOD DEMONSTRATES ITS POTENTIAL AS A NEW ORAL TREATMENT FOR RRMS
Late-breaking presentation of BRAVO results and additional analyses from ALLEGRO study reinforce novel clinical profile of laquinimod

Pre-clinical evidence supports that laquinimod targets peripheral inflammation and keyneurodegenerative processes occurring directly in the CNS
[Click here to read entire article]

Leading Organisations Launch New Coalition to Address the Needs of People with Multiple Sclerosis in the Workplace
Today, business and health leaders join forces to announce the formation of the ms&work coalition, the first group of its kind to address the needs of people living with Multiple Sclerosis (MS) in the workplace across Europe.

The coalition, an alliance of Merck Serono; a leading healthcare company, Microsoft Corp, Employers’ Forum on Disability (EFD) and the European Federation of Neurological Associations (EFNA) was announced at the 5th Joint Triennial Congress of ECTRIMS and ACTRIMS, Amsterdam, The Netherlands.[Click here to read entire article]

Extension Phase Data on Oral Teriflunomide for MS Released
October 21, 2011 (Amsterdam, the Netherlands) — The benefits of oral teriflunomide on clinical and magnetic resonance imaging endpoints in the pivotal phase 3 Teriflunomide MS Oral (TEMSO) study were maintained in the extension study, 5 years after randomization.
[Click here to read entire article]

These links represent just a fraction of the news coming out of ECTRIMS 2011. It's really refreshing and exciting to see so much research being done -- and with so many positive results! I would have loved to have been in attendance there and gotten to hear all the news first hand. I've been to Amsterdam once and it was beautiful!

Monday, October 17, 2011

Gilenya (Fingolimod) to be highlighted at ECTRIMS meeting Oct 19-22

This is awesome news! From what I read in this article, not only does Fingolimod reduce the relapse rate but it appears to also protect the brain from atrophy. I had heard hints of this before but it's expected to be backed by data gleaned from the very trial I was in (TRANSFORMS) when presented at the ECTRIMS meeting to take place today.

Basel, October 17, 2011 - Novartis will showcase data from 13 abstracts on fingolimod (Gilenya(®)), at the 5th Joint Triennial Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) taking place from 19-22 October in Amsterdam.
Novartis drug Gilenya® (fingolimod) has more than 20,000 patient-years of exposure and shows up to 71% reduction in annualized relapse rates in MS patients with highly active disease | Cision Wire: "Fingolimod 0.5 mg reduced the rate of brain atrophy, or brain volume loss, compared to interferon beta 1a IM over 12 months, irrespective of disease
activity prior to study start as shown in an analysis of the pivotal Phase III
TRANSFORMS study[3]. (Abstract P907)"

'via Blog this'

Sunday, October 9, 2011

Good to go for another six months

It's been more than a week since the most recent neuro checkup but life has gotten in the way of blogging about it.

In preparation for my first meeting with my new neuro who happened to also be the lead investigator in my clinical trial I had kept a calendar with scribbled notes of symptoms and issues I'd been having since August 5th. I felt I'd been having my first relapse (and no matter what anyone might say, I still believe it). I thought he would be interested to know.

I transferred all these scribblings from calendar to notepad and organized them so that I could recite all the pertinent information in chronological order and give him an overview or all the crap I'd been dealing with. It started with the 24 hour bug that had me so dizzy and nauseated I had to crawl on hands and knees to go toss my cookies in the bathroom.

Then it was on to a couple weeks of nearly bedridden fatigue. I defy anyone without either chronic fatigue syndrome or MS or some other disease that will flatten you face first to the pillow to try and comprehend what this is like. You can't. It's like you have suddenly fallen victim to an invisible monster who weighs a ton and sits on your chest pinning you to the bed. Any effort to resist or fight against it is futile.

When the fatigue started lifting after a week or so, I had that buzzing, funny-bone-whacking feeling in my groin again. I'd had this a year ago and underwent a battery of tests from CTs to ultrasounds, only to have it disappear before anything was every found. This left me feeling that it was most likely MS.

Well, it was back with a vengeance and I had to use my cane for 2 weeks lest my leg go unexpectedly out from under me. When that sensation occurred, it was without notice and would lock my leg up much like giving your elbow a good solid whack on the nerve will momentarily cause that (not so funny) buzzing whilst simultaneously locking your limb up and briefly rendering it useless.

I never knew I had a funny bone in my groin area, but sometimes MS is weird like that. Making it nearly impossible to define the symptom and explain it to anyone. Even my doctors (who have big labels on my files that say "CAUTION: EXTREME HYPOCHONDRIA" no doubt) will just look at me quizzically and nod, smiling. That infuriating, placating, condescending smile.

That's pretty much how this whole visit went. I thought I was coming armed with all kinds of documentation of my first ever relapse since starting the clinical trial for Fingolimod (now Gilenya) over four years ago, and he was just nodding and smiling. Never asked a question.

Instead he whacked my knees with his rubber triangle hammer, had me follow his finger with my eyes, stick out my tongue and walk across the room. He rubbed my left ankle and right cheek simultaneously and asked if they felt the same. I resisted asking him if they felt the same to him. "No, one feels like my ankle and the other feels like my cheek."

I knew what he meant but felt he needed a little help earning his pay, so a little playful obstinance couldn't hurt.

Then he said "Well, it looks like you are doing so well we don't have to see you for another six months! Isn't that great!!?"

And I just sat there. I couldn't meet his level of cheerfulness at this news without asking, "That's it? No blood work to check my liver? No urine?"

And he just smiled that dopey smile and said "Nope. You're doing fine. What I think you had there last month was a little viral stomach thing that just aggravated old symptoms. You didn't really have a relapse. You are doing so well and have been on this so long that we can just see you again in six more months."

Now some folks would say that was a great visit and why am I complaining.

Part of me wants to just take the same freakin' happy pill my doc had eaten and say what the heck and be done with it.

But most of me has alarm bells going off and wonders why, if this drug has only been on the market for a little over a year, and I've been taking it for a little over 4, and long term affects are not know, then WHY wouldn't you do routine blood work? There are possible issues with elevated liver enzymes -- I actually had one occurrence of that during the trial -- and so at the very least double checking that might be in order, no?

And he didn't seem at all interested in the fact that I'd had a breast cyst and had to have it aspirated. I had a surgeon try and talk me into a biopsy but chose to wait three months and have a repeat mammo and ultrasound.

I'll be scheduling those this week.

This drug works in ways that I obviously don't have the education nor background to fully comprehend, but I do know that it sequesters T-cells in the lymph glands. I do know there are lymph glands throughout our bodies. They couldn't tell me what that cyst's contents were as it contained too few cells to determine.

So, I'm happy that my doctor was so happy with all he'd seen at our visit, but I didn't leave there feeling all warm and fuzzy.

Maybe it's just the hypochondriac in me, but I'm still waiting for the other shoe to drop.

Saturday, October 1, 2011

BOGO Large Pizza Fund Raiser Card from Dominos

If you live in Florida, Georgia or Alabama, you can get a great deal on Dominos Pizza while helping my son raise funds for the end of year trip for his band class.

For just $10 you get a card that is similar to a credit card and is good thru June of 2012. Use your card to get a FREE LARGE PIZZA every time you order a large pizza! No limits!! Having a party? Imagine the money you'll save when you order 10 large pizzas and get 10 FREE!

He's got to be done with fundraising and turn in the money on Monday, October 3rd, 2011 (THIS MONDAY), so we need your help now!

Here's a link to read a PDF version of the flyer that explains it more in detail:

http://www.tiedyedhippy.com/band-1.pdf

To place your online order, just click the buy now button below. Be sure to include your shipping address. We will be mailing out cards the following week.


Thanks!!!
Jeri

Tuesday, September 27, 2011

Memory is a Matter of Perspective

Have you ever gone back to your childhood home to see the place you thought you'd never forget? I will bet your first impression was one of shock at how small the place is. You remembered it being much larger. But then you realize that last time you saw the place you were 8 or 10 or whatever and it WAS much larger because you were much smaller.

I had a similar experience this morning.

Six years ago when my son was only seven, he wanted to play T-Ball. We got the uniform, the bat, the shoes and all the other stuff you need to be a good t-ball player and good t-ball spectator and we managed to make it through one season before he decided it was not for him. He played right field and spent most of his time dancing with his shadow or watching birds and wasn't really into the game all that much.

I had been dealing with my MS for five years by that point. A cane was a permanent part of my wardrobe, and when I went grocery shopping I rode in one of their electric carts to get around the store.

I wanted to be involved in my son's life and encourage him in whatever he chose to pursue so I attended all the games despite the size of the sports complex and the fact that it was spring/summer in Florida which means sweltering heat and humidity.

It all ended after that first summer. He said he didn't want to do it any more and I was secretly relieved because it took so much out of me physically. It was such a huge place and just getting from the car to the field he played on (bottom left in Google image below) seemed like I was trying to climb Mt. Everest or cross the Grand Canyon on foot or something. It was a monumental task that often required rest stops along the way with occasional assistance from other spectators.




We had no reason to return to that ball field for the next several years until he started middle school. We got to choose which school we wanted him to attend despite our zoning and we chose the best one in the county. Unfortunately that meant a daily drive of over an hour to get him there and back. The trip was shortened dramatically when he started riding the bus which met us (and about 30 other families) half way. Where was the bus stop? The parking lot of that sports complex.

This is my son's 3rd year at that school and so for three years I have been parked in that parking lot which is surrounded by trees and hedges which obscure the actual sports complex. You have to walk past them to see the grounds.

Curiosity got the better of me this morning. I've been wanting to see how easy it would be to walk all around the grounds and it just so happened that an errand I was running took me past the sports complex during mid-morning when very few people were around.

I parked at the corner of the lot closest to the entry and got out. I had my smart phone loaded up with music and my ear buds in, ready to break a sweat walking all around the place.

As soon as I rounded the first hedge and looked down that never ending sidewalk I was stunned. The sidewalk wasn't long at all. Maybe a city block or so. Could it be that they've added things and shortened the walkway? Hmmm Everything still was as I remembered, just a lot smaller. No new diamonds, no new b-ball courts, same old concession stand.

I pressed on. I came to the "T" where I recall I would sometimes have to step off the path and set up my lawn chair to rest more often than not. I turned around, puzzled, and looked back to the parking lot.

Really?? That was as far as I could make it before? I was in total shock. The other sidewalk leading off of the T was not nearly the trek I recalled either.

After the shock of seeing the place I began to cry. I was so sorry for my old self and so happy for my new one. Tears turned quickly to smiles as I picked up the pace and made four laps around all of the connecting walkways and headed back to the car.

I never even broke a sweat.

It was one of the most telling and dramatic moments I have experience since starting on Gilenya. "You've come a long way, baby" doesn't even begin to express how I feel.

I might have gotten older in years, but I feel so much younger today than I did back then. Wow. Amazing to me how easily I slipped right back into taking even simple things like walking unaided for granted. I don't ever want to forget where I came from because I might miss out on feeling the sheer awe of what I can do now.

There's so much that is spectacular about "normal", "average", "boring" and "mundane". If you have the luxury of experiencing that, you are truly blessed.

Monday, September 12, 2011

Unexpected Tears

I had a meeting with a group of people at my son's school today. It was the annual Exceptional Student Education meeting to discuss his gifted education plan. What that means is that some of his teachers, the guidance counselor and the man who heads the gifted program sit around a table with me and my son and discuss their goals for him for the coming year.

The older he gets (he's an eighth grader this year) the more the discussion turns to his "plan" for after high school and how we are all going to help him get there.

Mr. Collier, head of the gifted program, in the middle of the meeting, said "I want to share something with all of you that happened this past week which touched my heart."

He went on to say that my son, who had come into sixth grade two years earlier with the goal of someday being a video game programmer had been showing remarkable signs of maturing over the past summer. He said that he and my son had a meeting last week in which they discussed his reassessed goals to see if he was still wanting to learn computer programming.

"That's when he said something that really made me proud and touched my heart," said Mr. Collier.

He said my boy responded "No, I've decided to go into science because my mother has MS and I want to find a cure."

The room went suddenly quiet for what seemed like a very long time.

I was sitting there with all of these relative strangers who, up until then, probably had no idea why I was using my cane today. After all, when they saw me at the end of last year, I was walking just fine. I could imagine a silent, collective "Ah! That's what the deal with the cane is!" going off in all their heads.

But that was only a fleeting thought. Mostly, I was so damn proud of my son. It felt as if his words had reached out and wrapped themselves around me in a big verbal hug.

And to hear them coming from someone he had shared them with when I was not around took me so off guard I burst into tears of joy right there and had to hug him in front of all those people.

He, of course, was thoroughly embarrassed and will probably stay as far from science as he can now in order to avoid any future situations like that.

But it was a moment I'll always remember. I sure love that kid.

Tuesday, September 6, 2011

A surreal encounter between epatient and pharmaceutical exec

All this time I never knew that I was living the life of an "ePatient". That's what they are calling us. We are the new trend that's been developing since the advent of the internet. Patients who no longer sit back and digest only what our doctors have to say or what we can learn from local support groups.

We are the patients who have gone electronic. The ePatients. We google, we surf, we join yahoo or Facebook groups, we tweet, we post, we reach out. We read everything we can on the topic that is nearest and dearest to our hearts. Our own health.

I started this blog in 2007 when I was wrestling with the idea of joining a clinical trial. My first instincts were to head to the internet and look for info. As naturally as the generation before me might have reached for the Encyclopedia Britannica, I reached for my mouse.

What I found was that I couldn't find information regarding a clinical trial from a patient's point of view. I needed so badly for someone to put a face on the process and tell me that a) not everyone dies if they join a trial and b) they didn't actually have to live at the study center in a cage, running on a wheel.

Deciding that I needed to take the chance despite the lack of e-reassurance, I jumped in. But I vowed to write a blog so that others after me might have a place to go. To look in through the exhibit glass and see that the "specimen" which was me, was doing just fine. Just don't tap on the glass or try to feed me anything but that 50-cent handful of pellets.

So the blog was born. I got much feedback from MSers who happened to land on my page by chance. Almost always it was either encouraging or inspirational. Many times it was both.

To this day it shocks me sometimes to know that there are actually people who are reading along. I guess I think I am sitting here in my solitary room, drafting my memoirs and merely storing them in cyberspace, forgetting that others can and do read it. Thank you for that. I am truly humbled.

But you are wondering when I am going to get to the point, aren't you? I piqued your interest with the title and, in my patented style, am taking forever to spit it out.

Drum roll please.........................................

It all started with the purchase of my new Android phone. Never having had a smart phone before, I was playing with all the gadgets it came with. One of them was Twitdroid. I set up my @FingoHead account and went poking around at what the app can do.

Now, while I appear to tweet fairly often, it's all an illusion. Behind the smoke and mirrors I have Twitterfeed doing all the work. Taking my blog posts, shortening the url, and posting to twitter for me.

Because of this, I never go there or see the direct messages I may have gotten. But with this new app on my phone and the fact that I was clicking around checking stuff out, I found out that @CraigLipset had DM'd me asking if he could talk to me about being an ePatient who blogged a clinical trial start to finish.

I answered on a whim, not digging any further to see who he was, figuring he was either a fellow MSer or a fellow blogger or something.

Imagine my surprise when, after sending him my email address, I get a response within an hour, and it's signed by Craig Lipset, Head of Clinical Innovation, Worldwide Research & Development for Pfizer Pharmaceuticals.

Wow. I needed a moment to absorb all that. And another moment to do what we ePatients do best: go google the heck out of him and see if it was legit.

Turns out it was. I won't copy and paste the email here, but let me just give you the gist of it. He is interested in the ePatient and the whole social networking angle. He said that he thought my blog was unique in that I was writing about my clinical trial from start to finish (with a lot of other crap mixed in, granted -- that being my observation, not his).

Here's the part that really gave me goosebumps: He said that he had followed my blog for the duration of the trial and that he has included the story of my blog in a few presentations: "including this past June at the NIH". What I wouldn't have given to hear that!! I wonder if there's a podcast of it somewhere?

Here is a very interesting read. A blog post written by Craig Lipset on the topic of the ePatient:
https://science.pfizer.com/content/epatients-and-clinical-trials/

Long story short (okay it's too late for that), he asked if we could speak by phone. I sent him my number and he called last Friday morning. We spoke for over an hour and we both learned from each other, I think. If nothing else, he learned about the person behind the blog he'd been reading, and I learned that Big Pharma actually has at least one genuine, nice, down to earth, caring person behind the neon sign.

A big part of the discussion revolved around the future of blinded clinical trials and drug companies not having control over patients comparing notes. In the past, if you were in a clinical trial, the only place you might have encountered a fellow lab rat might have been in the waiting room of the study center. Now we can find each other everywhere on the internet.

It's only human nature to want to reach out and know you aren't alone. And by sharing experiences we can bond and overcome our fears.

The trouble is that bonding comes at a price.

I believe that not only will we see the Placebo Effect that is documented in clinical trials and a known phenomenon, but we will now start seeing the Hypochondriac Effect, where you find out someone else who is in your particular study (and may or may not be on the same stuff you are on) has a side effect (which may or may not be due to the study medication) and you suddenly are dead certain you, too, are having that issue.

What I have learned over the years of blogging the trial and observing/participating on message boards and support groups is that once we start sharing the questions of "is this a side effect" it can snowball out of control and start widespread panic.

Deep down I think that all of us suffer to one degree or another of Hypochondria. Some of us just openly admit it. :)

I cannot stress enough to anyone out there who might be reading this as they search for answers to their health related issues: You should speak to your doctor first and foremost. Go for a second opinion if you don't trust what he's telling you, and if you MUST go googling, do so on Google Scholar. Granted the results might be a little dry and hard to read, but they will probably be far more trustworthy than JoeBlow55's posted opinion on some unmoderated message board. (I made that up about JoeBlow55 so if that's you, here's my disclaimer: JoeBlow55 is a fictitious character who in no way is meant to be construed as an actual person in real life).

So, we concluded our phone call and I was left pondering the future of the ePatient and clinical trials.

Hopefully I will be able to continue as a trial blogger in the future... I am awaiting word of Novartis starting the long term Phase IV trial of which I have heard whispers.

If I'm going to be poked and prodded, I'm going to be here blabbing about it.

It's therapy for me, and if it helps you any, well, that's good, too.

And if you are reading this, @CraigLipset, thanks for the call -- I felt like I had been pulled up on stage to dance with the band for a moment. Best of luck in harnessing the empowered ePatient. You've got your work cut out for you.

Tuesday, August 30, 2011

Most up-to-date safety data regarding Fingolimod / Gilenya / FTY720

Here is the latest safety information document last update on 7/2011 . There are certain people on the internet who are determined to link this drug to so called "new findings" regarding the issue of PML and Gilenya. They stand by their information citing the most recent changes to the drug data sheet updated on 7/2011.

Here is that document for you to read yourself:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf

Turns out if you search that document for "PML" or "Progressive multifocal leukoencephalopathy" you will not find any results.

BECAUSE PML IS NOT AN ISSUE WITH GILENYA / FINGOLIMOD / FTY20.

This is why so many doctors are considering switching Tysabri patients to Gilenya if they have tested positive to the JC Virus or are nearing 24 months on therapy.

I hope that this will ease the minds of those of you looking for accurate, up-to-date information regarding this medication. Especially if you are considering this as a therapy of choice.

While there are other serious side effects related to the use of this drug, so far PML is NOT one of them.

You just can't make this stuff up



This morning I was driving my son to the bus stop 20 min. from our house (the school itself is over 30 min. away but the best in the county so we sacrifice convenience for quality). I dropped him off and it's still quite early as I head back. It was about 6:30 a.m. and inky dark outside.

I am driving along when a sheriff's car pulls out from a side street and falls in behind me. Up ahead I am planning to turn left and then right in order to get on the street parallel to where I am driving in order to be able to cross the river to get home.

As I'm preparing to turn left I look in my rear view to make certain the people behind me are slowing down too (it's just a habit of mine to check and see if I'm about to be rear-ended). I notice the cop had turned his headlights off and I thought this was pretty odd considering how dark it still was.

As I was completing my turn I caught sight of both headlights in my rearview at once. One was off and the other was on. The cop had a headlight out!

I completed my left and then right turn so I was then driving parallel to the deputy. I considered cutting back over and flagging him down to tell him about it, then decided it was a waste of time.

But I keep looking down each side street to my right to see if I can see his car. About 5 blocks later, there he is. He had turned left and was heading toward me, one headlight glowing, pulling into a parking lot and getting in a take-out line.

How could I resist? I, too, pulled in the lot and swung up on the right side of my now captive audience. I waved at him through his passenger window. He rolled it down, inquisitively.

"Hi! Did you know you have a headlight out?" I ask cheerfully.

"Oh...yeah...that..." he stammers "it happened on patrol last night and there's no place open to get it fixed yet."

I look at him sternly and say "You shouldn't drive it until daylight then, officer," adding "I'll let you off with a warning this time, but you'd better get that fixed!" and I actually wagged my finger at him.

How many times have you ever been given the chance as an average citizen to pull over a cop?

And don't you know I laughed until I cried when it finally dawned on me where this all took place.

We were in the drive-thru line at Dunkin Donuts.

Monday, August 29, 2011

These idiots don't WANT anyone to post anything truthful apparently

I reregistered and posted the info I had found sans links in rebuttal to the post with all the misinformation about Gilenya.

AGAIN my account was suspended. This time for reregistering and apparently acting as an "authority" by trying to post some actual facts instead of spewing garbage like the other poster.



I'd say "what a joke" but it's no laughing matter when they allow incorrect info to be posted on their site and disallow any rebuttal. That is total irresponsibility as a moderator in my opinion.

(Edited to add a link to the post where I discuss what this is all in reference to.)
http://gilenya.blogspot.com/2011/08/setting-record-straight.html

Beware of HealthBoards the website.

The gloves are off. I'm warning all my MS friends, and especially those in search of information regarding Gilenya / Fingolimod / FTY720.

See my most recent post for the thread I found on healthboards(dot)com and my reply I had to post here as it was not showing up on their site. I was careful yesterday not to mention the site, but no more.

I got an email today saying there had been a reply to the conversation so I excitedly went to see if my post had finally "taken". But it did not. It was as if the 30 minutes of careful, thoughtful, informative reply never even happened. The reply to the thread was from the original poster who, as you may have guessed, was shocked by the PML information this idiot had warned her of with their misinformation.

I assumed my browser had just timed out trying to post the reply, so I quickly logged in so I could provide the original poster with correct info.

Here is what I saw (click to enlarge):



Really?? My account was suspended due to asking for links or criticizing someone? I ask you, dear reader, to go judge my response (in the immediately preceding post here: http://gilenya.blogspot.com/2011/08/setting-record-straight.html) and see if you think it was unjustly critical. And furthermore, I don't think asking for links to references that back up the garbage they are trying to spew is unreasonable.

To be fair, perhaps it was an automated process that suspended my account and perhaps a live moderator might be more understanding. However, my patience with their board and the idiots who are free to post their BS has worn down to a frayed thread. I'm done with it.

READER BEWARE! This is not the only message board or "group" out there that allows members to post misinformation being passed off as some kind of "fact" that they know to be true.

At least I will tell you when something I am saying is my own stupid opinion. And if I believe something to be factual I will at least do a little research and provide you with a link to what I've found so you can use your own noggin and judge for yourself.

Now I REALLY feel that a primer about how to research info for MSers is in order. Give me a few days to compose it.

Sunday, August 28, 2011

Setting the record straight

I have Google set up to send me email alerts when anything Fingolimod/ Gilenya related comes across the internet. Normally I might briefly check it out, but usually dismiss the stuff as old news.

Lately, though, there are so many people starting this therapy who are in search of accurate information to help them overcome their fear or at least give them knowledge on which to base their decision. When I see misinformation I can't help myself, I have to correct it.

I got such an email today that had a link to a discussion on one of the many MS forums. Someone wanted to know if anyone out there was on Gilenya.

A person who sounded for all the world like he knew what he was  talking about posted this:

I just attended a very intereting lecture on this drug last week. I had been considering asking my doctor about switching me in 2012; however after what I learned, Im not going to.

Gilenya is now being recognized as having some PML related issues, same as Tysabri....and the JC virus, which is what people get tested for before being started on either drug, makes over 50% of the candidates ineligible. I actually have the virus myself, they did blood draws at the meeting I attended. I got the results in 5 days.

The biggest risk besides cardio issues, is eye problems, making anyone who has had ON also riskier to take the drug. Macular Degeneration is an increased risk if you take this. The first dose and now they recommend the first 3 doses, should be done in a hospital or doctors office setting due to the risk of tachacardia- increased heart rate. This can cause additional problems down the road. The actual statistics which are available for efficacy arent that impressive and there is virtually no long term data available since the drug was released only this year for FDA approval for MS.

All of this is public knowledge if you do your homework, In my opinion the ease of taking the pill vs the risk, just doesnt cut it for me....but let us know what you think!

Naturally I had to respond. I went to all the trouble to create an account at this place, and it took me a good half hour to compose my rebuttal along with supporting documentation, and once I posted it's as if I was never there. Nothing showed up.

Not one to be easily swayed into giving up the discussion when I have invested so much time into composing my reply, I have decided to post it here. Maybe more people will see it and benefit from it anyhow.

Using my trusty "back" button on my browser I was able to return to the page on which I had composed the response and I'm copying/pasting it here...

My Response

I received a link to this discussion in a Google Alert email I have set up for all things related to Fingolimod / Gilenya. Usually I read them and dismiss them. I'm pretty familiar with the topic having been a part of the TRANSFORMS clinical trial and having just past my 4th anniversary on Gilenya. I don't know everything about it, granted, but know more than the casual observer or average MS patient.

The post by XXXX  however was troubling to me. Enough so that I felt compelled to create an account here on XXXX for the sole purpose of being able to ask for the sources for the information being provided.

First, where was this lecture you mention and who was providing the information?

Points you make that I disagree with:

1. Increased risk of PML. 
Where is the supporting documentation regarding this PML risk you speak of? You mentioned having your blood tested at this meeting for the JC virus. I believe you are mistaking the risks associated with chicken pox/herpes/shingles family of viruses with the JC virus. I have never been tested for the JC virus and I would think that if you were correct, that test would have been performed.  At the very least, if it were a new development as you say, my neurologist who also happened to be the lead investigator at my clinical trial location, would have gotten me back in there to test for this.

 From the Novartis website's Safety Information Guide PDF. (http://www.pharma.us.novartis.com/assets/pdf/REM/Gilenya_HCP_Safety_Information_Guide.pdf)

Patients without a history of chicken pox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV.

I WAS tested (as were all clinical trial patients and now so too are current candidates for Rx) for the VZV antibodies.

2. Risk of increased heart rate and first 3 doses in hospital setting.
The risk is with a decrease, not increase, in heart rate and this only occurs with the first dose. Unless you have had an abnormal EKG or significant drop in HR that does not recover during the first 6 hours, there is no recommendation for 3 monitored doses that I am aware of.

From the published trial results:
There was a transient, dose-dependent reduction in the heart rate that developed within 1 hour after the initial administration of fingolimod, which is consistent with the findings in previous clinical trials.12,13,23 Mean maximal decreases were reached after 4 to 5 hours of 12 beats per minute in the group that received the 1.25-mg dose and 8 beats per minute in the group that received the 0.5-mg dose, with the changes starting to attenuate within 6 hours after the first administration of the drug. Most patients had asymptomatic reductions in the heart rate of less than 20 beats per minute. Mild-to-moderate symptomatic bradycardia after the first dose of fingolimod was reported in four patients who received the 1.25-mg dose (0.9%) and in three patients who received the 0.5-mg dose (0.7%). Symptoms resolved within 24 hours without treatment. There were no cases of syncope. Second-degree atrioventricular block was reported during the first day of treatment in four patients receiving fingolimod — three in the 1.25-mg group (0.7%) and one in the 0.5-mg group (0.2%). Two patients in the 1.25-mg group had mild symptoms (intermittent dyspnea and dizziness in one patient and chest pain and palpitations in the other patient), which resolved within 24 hours without treatment. No significant effect on heart rate or atrioventricular conduction was observed with continued administration of the drug. Increases in mean arterial pressure occurred in both fingolimod groups (3 mm Hg in the 1.25-mg group and 2 mm Hg in the 0.5-mg group) during the first 6 months and remained stable between 6 and 12 months.

.3. Macular Degeneration as a side effect.
It's Macular Edema (swelling of the Macula at the back of the eye) that is possible, not macular degeneration.

From the published results of the TRANSFORMS trial: 
Macular edema was confirmed on central review in six patients receiving fingolimod — four in the 1.25-mg group (1%) and two in the 0.5-mg group (0.5%). In three patients, the macular edema was asymptomatic and diagnosed by ophthalmologic examination. Five of the six cases were detected within 4 months after the start of therapy. The edema resolved within 3 months after discontinuation of fingolimod in four patients, was unchanged 1 month after discontinuation in one patient, and was reduced 8 months after discontinuation in one patient. Mean visual acuity and retinal thickness were similar across the study groups and remained stable over the 12-month study period.

4. The actual statistics for efficacy aren't that impressive.
I guess that's a matter of perception and opinion. I went from relapsing every 3 months for several straight years with Copaxone  not making any difference to joining this trial in August of 2007 and going 4 years with no relapse. My study was a head to head comparison with 2 different doses of Fingolimod (1.25mg or .5mg) with Avonex. There was no placebo. We were blinded to the real drug until the end of the study. We had to take a pill and do a shot once a week. Turned out I was on the .5mg Fingolimod from day 1. The results of that study concluded that, compared to Avonex, Fingolimod had quite an impressive increase in efficacy.

Again from the published study results:
This phase 3 study shows the superior efficacy of oral fingolimod over intramuscular interferon beta-1a. Fingolimod reduced the annualized relapse rate to a range of 0.16 to 0.20, as compared with 0.33 for interferon beta-1a, corresponding to a relative reduction of 38 to 52%

I didn't come here necessarily to correct errors I perceived as much as to find out if there is any truth to the statements being made If there have been changes in documented findings for this drug I have a great desire to know. If you can substantiate your statements with supporting links, I'd love to see them.

I just have a strong feeling that while you meant well some of your statements were incorrect.

Link to data that supports my statements (see charts/images included for side effects, etc.):
http://www.nejm.org/doi/full/10.1056/NEJMoa0907839#t=articleTop

==================================

Now, I don't profess to be an expert and there is a slim chance that he/she was right and I am wrong because I'm using outdated material compared to the new data they could be referring to. But I DON'T THINK SO. I'm just sayin'.

It makes me mad as hell when people go off half cocked and start posting things they sorta recall from a meeting someplace and try to pass them off as the gospel truth. If you're going to make these claims at least provide some supporting documentation from a reliable source of authority. Don't just say "do your homework, the data is out there". 

There are people out there who have MS,  who are looking for some way to battle this insidious monster, and would like to not waste their time on reading stuff posted by idiots who have no business possessing an opinion.

Call me an idiot, but that's my opinion. :P

My next blog entry is going to deal with how to do research on the internet. It will be aimed at the average MSer who no doubt is experiencing some level of anxiety and wants to be reassured by the information they find online.

Friday, August 26, 2011

Could it finally be a MS relapse? Not earth shattering if it is...

I sat down with my pocket calendar and worked backwards, grabbing some dates from memory and some from my older blog entries. I think this has been going on for nearly a month.

It all started back around the beginning of  this month when I woke up one day and was sick to my stomach and so dizzy that I actually had to crawl to the bathroom to throw up. The dizziness scared the heck out of me (I've had it as a MS symptom in the past and DISlike it very much).

So I spent the day in bed  with a bucket beside me "just in case". I ate nothing and slept as much as I could. I took my temperature and it was absolutely normal. I sure felt like I had some kind of awful stomach bug but I didn't know you could have that without an accompanying fever. huh.

Turned out it was a 24hr thing. The dizziness was gone the next day along with the nausea, and I was back to eating. The only thing left behind in its wake was an overwhelming fatigue. The kind that pins you to the bed and won't let you up. The kind that increases gravity 10-fold and causes even the most mundane tasks to seem utterly insurmountable. I spent most of that week in bed, coming out only to force myself to do those things I could not avoid. We ate a lot of Tuna Helper and ham sandwiches during that time.

By the end of the week I was starting to get over the fatigue when I ended up having to make a trip to the ER. Not for me, but for my son who had been stung by a wasp for the first time and we all found out he apparently inherited not only his left-handedness from me, but my severe allergies to stinging bugs.

Maybe it was the stress of that day on top of the fatigue I'd been battling right after that awful stomach thing, but soon other little symptoms began raising their ugly heads. Try as I might, they refused to be ignored.

I was having intermittent numbness in my lower legs and feet as well as in my hands, coupled with burning pains and spasms. The severity of each symptom seemed to directly correlate to the amount of rest I had received during the previous 24 hour period.

Not wanting to admit that my beloved Fingolimod (a/k/a/ Gilenya) could ever let me down, I have been reverting back to my mindset of DENIAL as I remember from the first year or so immediately following my diagnosis back in 1999.

"Oh I'm just a little tired," and  "Maybe I'm coming down with something," were my two mantras looping through my head for the past couple of weeks.

But things are getting worse instead of better and demand my attention, refusing to be ignored.

That weird, buzzing, funny-bone-wacking sensation I experience for three months last summer (and despite extensive testing, no cause could be found) has mysteriously returned. This is such an odd thing I can't imagine even doctors being able to visualize or understand just what sensation I am experiencing. The closest I can come is this: I suddenly, randomly, and with no forewarning intermittently experience this odd sensation where my leg meets my body, at the groin area that feels like your elbow does if you wack it horribly on the nerve. There is ferocious buzzing and tingling while the surrounding muscles contract in a fit of spasms. My leg will contract and go out from under me.

So now I know right where my cane is after all these years. Within easy reach, that's where. I have come close to falling a couple times in the past few weeks because of this weird buzzing groin thing yanking my leg out from under me, so I'm not taking any chances.  I still see the scar from the gash I got last time I fell on my face every time I look in the mirror. I don't need to kiss the ground again, thank you.

The buzzing groin was an enigma last year. The clinical trial people pooh-poohed my questioning of whether or not it could be MS, and my primary care doc wore himself out dreaming up new ways to figure out what was going on. When an x-ray, a CT and an ultrasound revealed my only problem was that I was full of crap (literally, I had a constipation issue that amplified the groin buzz issue) I drew the line at getting the upyerasscopy.

Later, at the first neuro visit I had since exiting the study, Dr. Whosenameiforget told me it could DEFINITELY have been MS related and when I said it was worse when I was constipated he nodded, saying it made sense. There are nerves that travel through that area that come out of the spine, go through the groin and down the leg. With a full lower intestine and colon, the pressure placed on the nerve would be increased. He could easily see how it was a nerve thing and most likely MS.

Not to mention the fact that last year it mysteriously disappeared after never showing on any diagnostic test and was gone completely after 3 months... coincidentally the length of time it normally takes me to recover from a MS attack (if memory serves me).

Referring to my pocket calendar, let's see what else has been going on...

  • Eye twitching but I get that a lot anyhow if stressed or tired or mad (if you think you've ticked me off but don't know  for sure, just look me in the eyes. You can bet I'm NOT winking at you!)
  • Itching. Itching on my head, neck, side of torso, middle of my back. And never all at once, and never satiated by scratching. Back before the trial I could always tell when a new flare was coming on and guess the location of the lesion within several inches because of where the incessant itching was located.
  • Numbness in feet. Sort of feels like I have rubber gloves on them. Can feel cold/hot, but not especially fine sensations.
  • Tenderness in my left armpit and across the collar bone like I imagine where parts of  my lymphatic system reside.
  • When I lay down to go to bed at night my legs start jumping and twitching. It's a weird feeling. I can tell when it's going to happen because sometimes I get this stinging sensation like an ant bit me somewhere on my upper thigh or hip, and then within seconds my leg will jerk. If I wasn't so overly tired and wanting to go to sleep I might be amused and entertained by it, but mostly I find it annoying.
All in all it's a really wimpy list of symptoms, none of which are so earth shattering that I feel a need to go lie in a 8 foot MRI tube and get shot up with contrast dye to have them just say "yep, it's MS".

Besides, all they'd do is offer me steroids and I am so much happier to deal with these minor annoyances than I would be to deal with the roid rage I go through every time. Besides, that stuff makes me eat like there's no tomorrow and I INVENT meal names just so I can eat 6 times a day. "Oh! Look at the time! It's almost Linner! Better hurry and fix it or it will soon be time for Dinner and before you know it Dineakfast!" nom, nom, nom. And the acne, and the camel hump (NOT toe, thank you.), and the insane way my brain won't shut up, and the insomnia, and the weird taste in my mouth, and the unquenchable thirst, and the uncontrollable urge to clean. No thanks.

What I AM going to do is keep documenting my symptoms as this progresses, go see the doc if it really gets out of hand, and then on Sept. 28th when I go see my neuro I will bend his ear about all of this.

I have talked to a couple other folks in the Fingolimod trials who have definitely had relapses while on the drug and they have said what I suspected... you know you are having a relapse but it feels as if Fingo is keeping it in check. Like if not for the drug you might just explode into one of those horrible attacks that knocks your junk in the dirt.

If this IS a relapse and I'm going through the worst of it now, then I can handle it. I have not lost my gratitude for the drug, that's for sure. If anything I know for SURE it's working now. To go with no relapse for all this time could have just been a fluke. To have an attack and have it be so muffled as to leave me wondering if it really IS one, well, that to me speaks volumes about the power of Gilenya.

Saturday, August 20, 2011

Another Normal Boring Day - 4th Anniversary on Gilenya!

Today marked the 1460th pill I have taken since August 20, 2007. It's been 4 years since I started this study and I'm happy to report I spent a normal, boring, uneventful day much like anyone else I know. Totally UNlike the days I spent leading up to this trial.

If you had told me 4 years ago that things COULD get better and that I wasn't necessarily on a slippery slope leading to total disability from MS, I would have maybe laughed at you. Then again maybe not as my sense of humor was severely lacking from constantly being beaten down by my MS symptoms. I didn't laugh at much of anything back then.

Today, 4 years later, here is how I spent my day...

I got up at 9:15 after laying in bed watching TV for a while, deciding if I was ready to fight my right hip which has decided to remind me that I'm 50. They say you're only as old as you feel and most of me feels 18 but that stupid hip wants me to be eating prunes, sitting in a rocker knitting a shawl because it's a bit chilly in here. So the hip won out for a short while, but then I was up and making coffee.

I checked email, took my pill, got dressed, fed the cat. All boring stuff.

Note how taking my pill is nestled nonchalantly between two other mundane normal activities. That does not go unnoticed by me. It's been four years, but every day when I pop that pill out of its blister pack I am amazed that I am fortunate enough to be JUST taking a pill.

Used to be my morning went: get up, eat breakfast, get dressed, FRET OVER MY SHOT, fiddle fart around, PUT THE SHOT OFF, run errands, do other stuff and finally some time before bed, DO THE SHOT. It was the least favorite part of my day and was always dramatic and stressed me out.

But I digress. I took my son to the shoe store to get his back to school tennis shoes and since they were having a BOGO sale (well actually BOGOHO but that doesn't sound like something you should say in mixed company. The second pair was 1/2 off, suffice it to say) I found myself trying on high heels. My son was totally distressed about it. He said "that's not YOU, Mom! You look too weird! Take them off!!" And I said "Why do they not look like me? I think they're cute!"

His response? "You are flip flops and sneakers, Mom, not high heels." All I can say is he has only ever known the MS me and not the younger healthier me who loved to wear heels. I did end up putting the heels back on the shelf and got a Hello Kitty purse for my granddaughter instead. The purse will get more use than the heels would have, but the point is that it was a day where I actually dared to think it might be possible.

There have been so many things that MS has stolen from me over the years that even something so simple as putting 2 shoes on my feet in a store and standing there, not falling down, seemed like such a major accomplishment. Sure, maybe I'd look silly in them and I would never buy them, but the feeling I got of knowing I COULD if I wanted to...well that was priceless.

I also went to the parts store and carted the old battery from the lawn mower inside and exchanged it for a new one which I carried out and plopped in the trunk. Another boring, normal thing most anyone might do. Unless they walked with two canes like I used to. Those days may be fading farther and farther into the past but the memory of those times, and the realization of what a gift I have been given is always right near the surface of my mind.

People who have never know illness, or disability can maybe never fully appreciate the simple things. But once you have been there, if you are ever blessed with a new taste of normalcy, you will relish the little moments.

I felt the hug of my son today as he came in to see if I was okay after I had napped for a couple hours. There was no numbness as he wrapped his arms around me.

There was no excitement in my life today. It was boring and normal and just another day. Thank God I am so blessed. Normal is the most wondrous feeling of all.

Here's hoping for another 4 boring years. :)

Tuesday, August 16, 2011

Reminiscing about Recapping...

I was just searching my blog for when it was that I regained the ability to jump and run (in short bursts, no marathons) and I happened on a post that listed my pre-trial symptoms and how I was doing at the one year anniversary of starting the TRANSFORMS trial for Fingolimod (now Gilenya).

I thought it was worth drudging it up again for anyone searching to see how I've done on the drug, so here goes:

Clinical trial start date: 8/20/07
Starting symptoms:

  1. Numb legs.
  2. Severe burning in both legs from knees down.
  3. Unable to walk the grocery store (used the electric cart)
  4. Walked with a cane or often 2 canes.
  5. Unable to run, hop, jump.
  6. Severe panic attacks that necessitated use of Xanax as needed.
  7. Depression.
  8. Spasticity in arms and legs.
  9. Extreme fatigue coupled with insomnia.
  10. Bladder and Bowel *issues*. That's all I'm saying.
(there may have been more symptoms but I forget).

At one year anniversary:
Change in above symptoms:
  1. My legs aren't numb, except occasionally if I overdo it (the numbness comes back slightly but goes away with rest).
  2. Same thing with the burning -- only upon overdoing it.
  3. I can walk the entire grocery store and even PASS other slow pokes while doing so.
  4. I do NOT use the electric carts or the blue parking spaces.
  5. I don't know where my cane is.
  6. I can run across the yard, I can hop on both feet or either foot, I can JUMP!
  7. I haven't had any Xanax in at least 11 months.
  8. I'm no longer depressed. (I never took any medication for it either).
  9. My arms and legs still have some occasional spasticity.
  10. I sometimes take naps in the afternoon -- getting fatigued if I eat too many carbs at lunch.
  11. The insomnia thing I still have some trouble with. Some nights I fall right to sleep, other nights I go to sleep and wake up a few hours later, and some nights I don't fall asleep until the wee hours of the morning. It all depends. I adjust my naps accordingly.
  12. Thank God the bladder and bowel issues are over.
=====================================

So now, three years after that update as I approach the 4 year anniversary (8/20/11) of my start date, I can say the only things that have changed may be that I no longer have insomnia and the spasticity in my arms is totally gone and the spasticity in my legs is more of a morning stiffness which I may or may not have had despite the MS since I am *getting up there* in age.

I didn't really remember just how bad I felt getting into this trial. The mind tends to make us forget the lousier parts of our lives so reading that back over I was kind of shocked into a vivid memory and I can truly say that life with MS before this drug was pure misery.

I'm all for living a healthy life and trying to do as much as you can for yourself without the use of pharmaceuticals, but when you are up against a wall and suicide is looking like an option, drugs don't look so bad. Gilenya has my respect, gratitude and admiration. Without it, I can honestly say I probably wouldn't be here.