If this gets approved, I'm in heaven!

I was just thinking about how nice it is that I only do a shot once a week. I'm sure those of you who haven't had a shot since getting their last boosters as a child would beg to differ, but for people with MS, shots are a part of reality. A necessary evil.

Since getting diagnosed in '99 I have had to stick myself on a daily basis (well, okay, my family knows that I fell off the shot wagon for a while and then got back on). Copaxone was the MS fighting elixir of choice. A tiny needle the goes only into the fat just beneath your skin. But the medicine it delivered was like battery acid. The stuff burned and there's just no way of getting around it.

At no time in the history of MS medications has a person been able to take a pill once a day that is designed to modify the course of the disease progression... until now. True, I can't pull the sheet out of the box and read about side effects or what not to take it with, etc., but I take my one pill a day and that's it. Well, except for that once a week shot, but who's counting? I do it Monday morning and by Monday afternoon I'm over it. It's done, gone, forgotten. For a week!

From what I have read recently, Fingolimod may even be able to repair previous damaged caused to nerves by multiple sclerosis. If that's the case, not only should I have fewer relapses to look forward to, but maybe I'll get some feeling back in my feet and not be quit so off balance.

It will be a sad day if, at the end of this study, Fingolimod doesn't get FDA approval. I will miss my little brown pill and all that it represents to me as a future that looks so bright.

For now it's looking good. No side effects and no relapses so far. You would probably say that two weeks isn't long enough to say whether it's making a difference in slowing the relapses, but consider this: I have been having relapses on a continual basis every three months for the last two years. I couldn't catch a break. Just when I would start to heal from one flare, another one would wash over me. Like an ocean of symptoms that threatened to drown me, I could get no relief.

My last round of steroids (which is all they can do for you to quiet down an acute attack) was back in June of this year. This is now September and I am having no signs of a new attack. All is quite on the MS front. I hope it stays that way, and with this medicine I'm pretty confident I will.

How nice it is to finally be able to get back to the business of living. Just having a regular life without constantly being nagged by your body that you have a disease is a nice thing. If Fingolimod gets approval I will be the happiest woman on earth. Well, the only request I would have would be to give it a jazzier name. Something like "Gold Finger" maybe? James Bond fighting M.S. -- I like the visuals.

Worrying myself sick

Is it really possible to make imagined things become real if you really, really believe in them? It didn't work for me when I tried it with Santa Claus or winning the lottery. But I do feel there is power in positive thinking.

For instance, I'm walking just fine these days and it is because I am doing well with my MS... or at least I think I am. Could it just be that because I don't have all the facts and I only perceive that I'm doing well that I am a walking miracle? If so, I don't want to know the results of all the MRI's I have had lately.

It could be that the reason they've been "lost" or never received by my new neurologist isn't due to miscommunication between hospitals, but rather I am a curiosity being studied by a team of doctors. Maybe they have seen my MRI's and know that I should be a vegetable confined to a bed, but realize that because I don't know this, I am still up and walking.

In that case, I don't want to know. I believe in the power of positive thinking because I have seen the power of negative thinking. I do it to myself all the time. I can talk myself into a panic attack quicker than you can say "OH NO!". And I even have this detached, analytical part of my brain that sits back saying "there you go again... you brought it on yourself."

If it's true that negative thinking can effect your health, then why can't positive thinking? Today I'm practicing "The Little Engine That Could" alternative medicine. I am going to feel better, and thus BE better, because....

I think I can, I think I can, I think I can.

Just between you and me, I'm sick of worrying myself sick and I think I'm going to give it up as a hobby altogether. If anyone has any great links about the power of positive thinking that they'd like to share with me, I'm all ears. Please post them as a comment.

Is it Fingolimod or is it Avonex? Only the scientists know for sure.

I'm not sure I'm taking to being a lab rat too well. It was okay for the first week. I was skating through life just taking my little dinky capsule every day and managing just fine.

Then today was the dreaded Shot Day. I had to get over the fear of the honking big needle and just do it, like Nike says. I was up at quarter to five for some unknown reason and sat around thinking "well, four more hours and I'll have to do that shot."

Then I decided that was stupid to do a count down and get myself all worked up, so I got the shot out of the fridge and went ahead with it. Everything went exactly as it did last week when I was a spectator while my nurse gave me the shot. Smooth as silk, the needle slid right in. I didn't feel a thing.... It was no biggie at all.

Then about a half hour later I started feeling a little dizzy. I was at the computer and sometimes it will do that to me, so I got up and walked away from it. Next thing I know I'm feeling nauseated as if I were sea sick.

Up until this morning I was positive I was on Fingolimod. Now I'm not so sure. Yes, my heart rate did drop on the initial dosage, so I probably am, but what's the deal with how I'm feeling today??

One thing that's hard about having a chronic disease like MS: every little thing that happens to you, you want to attribute to MS or the meds you are on. Could it be that I'm experiencing... a stomach flu? I often forget that I'm still prone to all the normal stuff that health people have.

I'm feeling better now, 8.5 hours after the shot. I'll know for sure next week if I get sick on Monday again.

I'm not so sure I like not knowing what I'm putting in my body. I thought I would read the enclosed pamphlet that came with the Avonex to see what the side effects are. Turns out that great big piece of paper (that's folded in half at least 8 times despite what MythBusters says is the absolute maximum possible) is only the instructions for administering the shot -- written in about 13 different languages.

Apparently when you are in a clinical trial even the FDA approved stuff that you take doesn't come labeled and packaged the way Joe Customer would get it.

I'm so glad I restrained myself and didn't go running to the local ER with a fist full of strangely labeled weird drugs they have never heard of. I"m sure it would have blown their minds. No, instead I got out a pocket notepad, and, like any good participant in a science project, I recorded my symptoms and the date and time. I'll let my neurologist make heads of tails of all the chicken scratch when I go for my 2 week check up. That's why he gets the big bucks.

My Daily Pills

Just so you can get an idea of how really small this pill is, here's my daily handful of the pills I take.

Starting from fingertips down, Fish Oil, Centrum multivitamin, Calcium with D, B-12, another calcium with D, and Fingolimod. It's the tiniest thing I have to swallow. I often gag on the calciums and the daily.

Someone else in the trial said they had no side effects from either drug (Fingolimod or Avonex) upon initial dose and she wanted to crack open the capsule and see what the stuff inside tasted like. Not me! It's probably ghastly and I don't care to know. Besides, I'm pretty darn sure my pills aren't placebos.

Fingolimod Facts

I guess since there's basically nothing in the way of side effects to report, I need to dig up some Fingolimod Facts to bide my time until I can report on my first update neurologist visit.

Fingolimod is a still-investigational drug that, given orally, acts as a superagonist to sphingosine-1-phosphate (S1P) receptors on the surface of thymocytes and lymphocytes, causing them to be sequestered in secondary lymph organs.

What that means is the misbehaving T cells that are thought to be the attackers of the myelin in MS are not allowed to come out and play, but kept in the lymph glands until needed for a real (as opposed to imagined) invader's attack.

This reduces the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS.


These lymphocytes are apparently a lot like undercover cops dispatched at a concert... going around acting all normal and blending in until a problem arises. Then WHAM! they are there to attack the rioters (myelin). Unfortunately, these lymphocytes are like bad cops ... they react first and ask questions later, beating the myelin into submission without asking the axons (the nerve cells) if they were buddies with myelin or not. These bad cop/lymphocytes can get so carried away that they not only beat the myelin to a pulp, but also give the axon itself a pretty good working over too.

Fingolimod is going to keep the bad cops sequestered at the station on desk duty.


FTY720 is a chemical modification of the ISP-1 metabolite of the fungus Isaria sinclairii (Dong Chong Xia Cao).

In other words, it comes from a Chinese fungus. With all the recent toy recalls maybe I should rethink ingesting a fungus from China. hmmm

Fingolimod was first used in clinical trials with transplant patients to see if it worked better than conventional therapies for reducing rejection.

Apparently the final conclusion was that it was no better than what the doctors already had to work with.

So, in researching facts to add to this post I have come to the startling conclusion that I really don't know a whole lot about this little pill I'm popping every day. Of course I don't know a whole lot about my vitamin and I take that. FTY720 has shown me about the same number of side effects as my vitamin, too. Zip, zilch, nada, nyete (okay now I'm just showing off).

Every once in a while I think "ooooo, my hands are getting sweaty and my heart is beating a little fast and I feel like I can't catch my breath..." Then I realize that's not a side effect of Fingolimod; I'm having a stupid panic attack. Then I chill out and I'm fine.

Photo montage of the clinical trial so far

Make photo slide shows at www.OneTrueMedia.com

The mystery medicine is in my system

Yesterday was the day. I had the pleasure of having to get up at 5:30 a.m. on the next to last day of summer so that I could drive for 2 hours through morning rush hour traffic to go take a pill and get a shot. I can't tell you how thrilled I was.

My sister offered to go with me, so we made elaborate plans about what to eat and which movies to watch. She brought all the makings for subs in a big cooler, I brought drinks in a small cooler.

When we arrived there was a flurry of activity; my blood pressure, pulse and temperature were taken along with my weight and height. Then I was covered with sticky pads containing leads for hooking up to EKG and Holter monitor. Fortunately, then nurse told me, they just recently got the double lead pads, otherwise I would have had to wear twice as many sticky pads.

After all the prep work was done, all there was to do now was wait for the nurse practitioner to arrive. She got stuck in Jacksonville morning traffic as she had to wait for the stop and go of passing by two fender benders. I wasn't complaining and sat patiently, contemplating all the wires hooked up to me and wondering just what I was going to "feel" when the new meds hit my system.

When she got there, we made a little small talk -- she's the same nurse I have seen on various office visits to the clinic, so we already know each other. Just having her smiling face there, reassuring me, was enough to get rid of the butterflies. She looked my EKG over carefully (turns out she has 11 years experience in the cardio field and that's why she was asked to be in on this study). She said I had a very normal heart. (YAY!) Then all that was left was to choose my poison.

I got to choose which to do first, so I figured the pill would be easiest. Everyone knows how to swallow a pill. She had to open the medicine bottle in front of me -- I guess so I know I'm getting the study drug and not a Tic Tac or something, but really...how am I to know? I mean, look at the label. Would you understand it? Besides, how do I know this particular bottle is the one the pharmaceutical company wants me to take? I might be getting 2 placebos or 2 active drugs for all I know. But I'm not going in that direction because it could drive me crazy and that's a very short trip.

I trust the people I'm dealing with in this study and I'm sure they have checked and double checked that they gave me what I'm supposed to get.

Anyhow, I look in the paper cup when she hands it to me and am pleasantly surprised to see an innocuously small gel cap that was brownish red in color. I pop it in my mouth, take a swig of water and it washes down without so much as a bump into the back of my throat. My first thought was "oh no. no turning back now...what have I done?" Then that feeling passed and we were on to the more important issue. The Shot.

I was scared to death of this part and I know it's stupid and silly -- after all, I have given myself shots on a daily basis for many years -- but this needle looked really huge in that video I posted a couple of days ago.




She gets the box of medicine and very unceremoniously rips it open. Out comes the pre-filled syringe and the needle, wrapped in it's own little package. She asks me where I want the shot delivered. I say "what are my choices?" Either thigh, either arm, or butt. I wanted to see what was going on and I'm not going to be giving myself a shot in the butt or arm, so thigh was my choice.

She tells me the shot should go in the outter half of my thigh, somewhere in the center 1/3. I didn't know I was going to have to be good at fractions to be able to do this, but I listen to her and nod like I'm understanding it all. She wipes with alcohol, and the next thing I know I'm seeing that big needle sink into my thigh like I was the Pillsbury dough boy's sister. It went right in with no effort at all and I couldn't even feel it. She pushed the plunger and I braced myself for a sting or burn as the medicine hit my muscle, but ... nothing. It was at that point that I'm thinking "hey!! I bet that was just water!!" which means I can quit worrying about Avonex side effects and worry about Fingolimod ones.


With all the drugs in my system and me all hardwired to a Holter monitor strapped to my waist, I go off in search of my sister. She left the room when she suspected the needle might be coming out. She's a big wuss and can't stand the sight of needles, but I love her even so.

She had meanwhile been tracking down the place where we would be spending the next six hours for observation. She scored us a conference room with a huge long table and fairly cushy "exective" chairs that swiveled and leaned back the way exectives like to do.

First thing I did once they left us alone was to sit at the head of the table and say "I suppose you're all wondering why I called this meeting today." I couldn't help myself -- I've always wanted to do that. My sister wanted to alter the words on the dry erase board that were all neurological terms. She wanted to misspell them so some doctor got embarrassed next time he saw what he had written, and then spend all day trying to recall why he didn't catch that when he did it.

When we were sufficiently amused, we tackled the TV. I came armed with all my movies and decided to watch "Holiday" first. I popped it in and the day of waiting began. An hour later the nurse came in to take my vitals. I made the mistake of saying "you don't have to tell me... I'll just peek over your shoulder while you write." So she covered it up. I still didn't have any fever, chills, body aches that are common with Avonex, so I was just waiting. With all the research I had done on the side effects of Avonex, I never did pay attention to how quickly they come on, so I still had no clue which medicine may have been real.

Hour after hour went by, pretty uneventfully. At hour 3 I told the nurse that I was sure I was on the Fingolimod because I wasn't sick yet and my heart rate had dropped from 80 to 64 (the reason for all the heart related testing since Fingolimod can drop your heart rate by up to 25 beats per minute upon initial dosage). She laughed at me and took my vitals. She held the clipboard so I couldn't see what she wrote, but I saw her hand swirl in the motions necessary to write a "6" and "4". "Aha! I knew it!" I said and she laughed.

We made a couple of trips to the parking lot for the retrieval of various things. On the one trip we made together, to get the coolers, we caught the same elevator as Dr. Kantor, the lead investigator in the study. I tell him I'm there for randomization and he said he knew that. Then I tell him "I think I know which drug I'm on!" but he quickly puts up his hands as if to ward me off and says "Don't tell me!! I can't know!". Sheesh! like I'm an expert?? He never believes anything I say any other time, why worry about what I think?

I tell the nurse about our ride in the elevator and she said "If you compromise the blind, they question the data." That made sense to me.

At the end of the 6 hours another EKG was performed and the nurse read the results comparing them to the pre-medicated one. She pronounced that everything was fine and after an education in how to inject Avonex I could go home.

I got to learn about how injecting something subcutaneously (under the skin) was different from injecting IM (in the muscle). It seemed simple and besides, I don't have to worry about messing with it for another 5 days. I'll worry then.

So, that ends the initial phase of my journey and so far I'm happy with the results. For a full blown hypochondriac to have nothing to complain about is a rare event indeed. The mystery medicine is doing it's job and I couldn't be happier. Now I can get back to my regularly scheduled program called Life.

There will probably be less entries unless I can find something to talk about and still stay on topic. Just wanted to let you know I appreciate the comments and the emails. Nice to have such a team of cheerleaders on my side.