Thursday, December 24, 2009

I'm Number 1! I'm Number 1!

Everyone! Put on your big foam fingers and chant along with me! I'm number 1!

(No, she's not gone off her rocker... yet.)

I had my trial checkup last week on the 16th because waiting until the 22nd as planned would have meant I ran out of my drugs before I could see my supplier, er, trial coordinator.

This time I took my friend Karen (whose dearly departed husband I blogged about here) with me. She and I have been friends for at least 25 years now as she has pics to prove it even though my 11 year old swears that's a young boy in that pic. Can I help it I was more *svelte* back then? (ok, flat chested and narrow-hipped with a hairdo like David Cassidy) We just sort of went our separate ways about 15 years ago when everyday life wedged itself between us. Joe's death brought us back into each other's circle again.

So, she went with me on the long ride there and we had a ball. Amazing what stuff you carefully spend decades trying to forget -- and with the help of MS cog fog you successfully do -- until you meet up with someone who likes to say "remember when you _____(fill in the blank with some stupid thing you did)? That was funny as hell!" Glad I could amuse in an everlasting way like that. heh

Anyhow, the checkup was pretty much SOP with nothing new to learn. She had already told me of the unblinding of my TRANSFORMS phase III extension phase study and I know now that I have been on Fingolimod at .5mg for the entire duration. Nothing new to surprise me there.

Then I had my EDSS performed by the same neuro I had last time. She's a young lady who appeared to have swallowed a watermelon last time I saw her. She knew of my having been the last patient the eye doctor (for the study) saw before going into labor and so she had asked if I could rub some of my mojo on her hand because she, also, was due and ready to pop.

When I saw her this time, she's back to her skinny self and her baby is only 1 week younger than the 3 months it has been since we last met. My mojo once again worked and the legend grows exponentially.

She started doing all the follow-my-finger (not to be confused with pull-my-finger or that could be embarrassing) stuff and the exam commenced. Nothing remarkable to speak of.

The whole time I was explaining to Karen how I've always been amazed at the weird stuff they have me do and that I've always asked questions about what each test meant. Right about that time, the doctor was having me take the heel of my left foot and run it from knee to ankle down the shin of my right leg.

I said "I have no clue what she's learning from this tho." and Karen, not missing a beat, said "that's the test to see if you're sexy." My neuro burst out laughing.

She also had a good chuckle when she got to the question they always ask and I always (before) gave the same answer.... "Are you having any sexual dysfunction?" she asked.

"I don't know. I haven't had sex in 3 years." was always the answer before. This time, I had told Karen about that particular question/answer on the drive up and she gave me an idea for an alternative answer.

So, the neuro, staring at her clipboard with her pen poised to check the little box, asked me "Are you experiencing any sexual dysfunction?"

And, without missing a beat, I asked "Do you mean WITH someone?"

A good laugh was had by all.

Then came the 500 meter walk, otherwise known as "Walk this hall 25 times or until you drop dead." Karen was going to walk with me but she's got Oyster Foot and didn't feel up to it. (what's Oyster Foot? She got her foot all cut up years ago jumping from a boat into shallow water wearing only flip flops and got some bacteria in there that apparently won't ever go away and causes a constant pain. huh, I didn't know there was such a thing).

So I walked the hall myself and Karen stood at my exam room door doing cheers each time I passed by. On the final lap, she darted into the bathroom just across the hall from my exam room and nabbed a roll of toilet paper. Whirling off about 4 feet of paper, she jammed the end with the roll still attached into the file holder that was mounted on the wall beside my exam room and strung the rest like a finish line across the hall.

As I approached, I raised my hands in the air in victory and noticed she was humming the theme from Chariots of Fire as I broke through the paper finish line.

Giggling uncontrollably, I wadded up my "finish line" and jammed it into my totebag as a keepsake of the most rewarding 500 meter walk I have had in the trial. I told her I'd be reaching into my purse and whiping my nose or other unmentionables with my treasured finish line before I remembered what I saved it for.

As I was leaving, I asked the trial coordinator if I could know what my EDSS score was now that the trial was unblinded.

It was the best news yet! I'm a 1! (0 being normal and 10 being dead) I'm a 1!!!!

I'm Number 1! I'm number 1! And I owe it all to this pill. Amazing! Simply amazing!

Wednesday, December 9, 2009

Amazing News I Knew All Along, or the Unblinding of the TRANSFORMS Study

I was supposed to head to Jacksonville for me quarterly clinical trial checkup in the TRANSFORMS FTY720/Fingolimod study today. Rarely do I have to reschedule -- in fact I can remember only 1 other time in the past 2yr 4mo since the trial began and that was because of a hurricane.

This time I was faced with my 11 year old getting off a school bus at noon with nobody to pick him up if his mother was in Jacksonville.

The schools do this quirky thing as they have ever since the 2004 hurricane season when so many storms crisscrossed our great state of Florida. They now make the school day last 15 min longer every day, and if we have no days off due to inclement weather, school will let out 1/2 day early 1 day a month... always on Wednesday for some stupid reason. It couldn't be a Friday so we could plan a long weekend or something. It has to be Wednesday when people who work for a living have to find time to go get the kids and then find someone to care for them until their parents get off work.

Not that I have to worry about that because the only job I have that I can't get up and walk away from at the drop of a hat is caring for my elderly mother. And she's pretty self sufficient anyhow, so I can get up and walk away from that, too.

But I digress.

I didn't have anyone to pick my son up since my other son's car broke down. So I had to call my trial coordinator at 3:00 on Tuesday to see if she could reschedule my 9am Wednesday appointment.

Usually when I call I get her voice mail, so I was pretty much figuring I'd just have to take my youngest out of school all together for Wednesday and drag him to my exciting and ultra educational clinical trial. Sort of a science project field trip. At least that was how my mind was whirling as I tried to justify that approach.

But she answered on the first ring and had no problem moving my checkup to the 22nd instead.

"Since it's just a blood draw and your EDSS it's not a problem. Now, if it were an eye exam, that would be another story since that doctor is so backed up."

"By the way", she said, "I was going to call you today anyhow..."

(and I'm wondering WHAT NOW??!! and worried to death.)

"Novartis has changed the trial again." (so now I'm thinking I have another War and Peace sized Informed Consent to re-sign).

She continues on...

"They have unblinded the study and you are now in the Open Label Phase.

OH CRAP! was my first thought. The party is nearly over and I'm having way to much fun to take off my lampshade and go home. I'm hoping I can feign losing my keys in Novartis' couch and talk them into letting me just hang out for a really long time in their comfy clinical trial confines. With all the nice people who have become my only social circle outside of immediate family. (yes, I already know how pathetic that sounds, but the truth can be ugly).

Then she proceeded to unveil, without so much as a drum roll, the results of my particular study.

Seems she was just finding out what I've known all along. I've been on the Real McCoy since the first day of the trial, and the lower of the 2 doses at that. Just what I prayed for and got (unlike the pony when I was 10, but this is waaaaaay better in my opinion).

The choices were:
1. High dose Fingolimod (1.25mg)
2. Low dose Fingolimod (.5mg)
3. Avonex (the interferon already approved and on the market, used as a comparison)

I knew I wasn't on the Avonex because I never had the first side effect. Not any injection site irritation (beyond the "OUCH" that you would expect from a 2" needle) nor any of the notorious *flu like symptoms*.

And I was pretty sure that I must be on the low dose Fingo because I'm the same person who needs a quarter of the weakest Xanax they make to take the edge off for an MRI. In other words, just let me sniff the pill bottle and I'm good.

And now I hear that they are converting everyone in the trial to the low dose. If you were on high dose through the initial phase (where we all had to do the once a week shot and take a pill every day) you would have entered the Extension Phase on that same high dose. Now, however, you will be put on the low dose.

So that way, no matter what any of us started out taking, we are all going to be singing the Fingolimod Praise Song as one unified chorus all on the same drug at the same strength.

And sing it's praises I will!

I have now gone the longest length of time between relapses ever. No relapses in the 2 years 4 months of the study and my last one was in April 07. Another 4 months and that will be THREE YEARS RELAPSE FREE! Oh my God it's just like being given my life back! Nothing short of a miracle in my book.

Novartis, if you are listening, THANK YOU for the opportunity to be in this study. Thank you for pursuing it as a treatment for MS and thank you for giving it to me for free for life.

Ok, ok, I may have jumped the gun on that last part since you never said anything about that, but you have given me a taste of the good life... far more valuable to me than if I had won the lottery or any other material gain. You have allowed me to run and jump again, to get a head cold and not cringe in horror waiting for the relapse that always used to follow, and you have allowed me to keep up with my kids and grandkids in a way I never thought would ever be possible again.

It's going to be a sad day when I have to say goodbye to the clinical trial staff. They are my friends. But what I will miss most is that precious pink pill I have so long paid homage to here.

Because I don't have insurance and won't be able to pay for it again.

I will feel like Algernon, I'm afraid.

But thanks for the 3 years of high Quality of Life your trial did give me (I'm assuming you won't kick me out before it's over so that's why I'm saying 3 years).

Hey! I have an idea!! Don't you guys need someone to be on this long term to study, so you can see the cumulative affects over many many years?? I'm your volunteer!! And all it will cost you is one pill a day.

I'm easy like that! :P

Sunday, December 6, 2009

Blowing the dust off

And blogging again.

Sorry I let 2 months go by without so much as a peep. Rumors of my succumbing to side effects from the clinical trial drug have been greatly exaggerated (to paraphrase Mark Twain).

Since we (I) last spoke, I've just been busy with life. Living at Mom's means doing all those normal daily things like cooking and cleaning and doing dishes and stuff on a more regular (like normal people do) basis.

We no longer live smack dab in the middle of town so we can't just *run out* for whatever whim-driven thing we need. No, now logistics and lists and travel routes and plans all come into play. When it's a 20 minute drive to anywhere you want to go, you don't just run out for a gallon of milk.

I'm doing a LOT of driving these days. We moved east by 10 miles from our old place, while we put our son in the best middle school in the county 20 miles in the other direction. So we live a 30 min drive from school. Funny thing is, if he rides the bus, we have to get up 30 minutes earlier (5:30) in order to make the bus on time (at it's last stop 20 minutes from home). But if we drive the whole way we can sleep in until 6 and still get out of the house by 6:30 and make it to school by 7 so he can have breakfast before first period.

I'd rather sleep that extra 1/2 hour and get a 1/2 hour of one-on-one parent/child time in the morning. Of course we spend it honing our improv routines. My son is quite the comedian. It's only gotten him in slight trouble so far. One kid wanted to kick his ass for pronouncing his name with an exaggerated English "hoity-toity" accent. The other kids loved it and asked for a repeat performance. Jack Gogan didn't think it was so funny when he pronounced his name "zjaaaahk go-gaaaaahn" however and we had to give our son the "he's more afraid of you than you are of him" and "if he was going to kick your ass he'd have done it and not talked about it" pep talks.

Anyhow.... I got side tracked. He's a real comedian and I'm proud of him. He makes me laugh on a daily basis.

The other day we got the mail from the PO Box. The one on top was a window envelope that had great big letters on it saying "BILL ENCLOSED". He grabbed the envelope and held it up near his mouth and said "Bill! If you can hear me, we're gonna get you out of there! Just hold on, Buddy! We called the fire department and they are bringing the Jaws of Letter Opener."

I said "hey! At least it's a window envelope so he can see out." To which he replied "I can see through the window that they have your mother in there too... see her name right there?"

So, anyhow, we love our morning drives. And because I do so much driving all the time, I'm away from the house (and computer) more.

And because I don't have any earth-shattering news to report about Fingolimod or my trial, I guess I've just not thought about it.

I'm so BLESSED to be at the point in my life that I've had MS for 10 years and yet I can forget about it. I have no constant reminders other than some stiffness in my legs in the morning (which could very easily be due to age as much as MS).

I think about those MSers who are less fortunate. Who are wheelchair bound or constantly struggling in some other way to deal with their MS on a daily basis and I am moved to thankful prayer. I have to thank God daily that I have a normal boring life again.

And with that normal, boring life I would like to make some kind of mark on the world with the gifts I have been given.

I want to either write children's books or get back into doing my artwork. I used to be quite good and to turn from that and give it up like it's something I got tired of is sort of like telling God I didn't care for that scarf he got me. IT'S A GIFT! I need to appreciate and use it... before it could be gone in a flash. One good relapse and my drawing/painting/sculpting skills could all be a memory.

So maybe I should start drawing again.. and maybe I'll share my creations here. It'll give me a reason to come back and post.

As far as my trial goes, I'm headed up Wednesday the 9th for another poking and prodding session to be rewarded by 3 more bottles of the magic potion.

I heard that Merck got a "refused to file" letter from the FDA in regard to their oral med, cladribine, so that's making it a closer race. The drug companies can fight all they want over who gets to claim their spot in history as the first to offer a pill for MS. The winners are going to be the thousands of MSers who get to benefit from their effects.

Maybe not everyone will be as fortunate as I have been... to have no more side effects from the pill than they get from a daily vitamin... but hopefully they will.

And -- knock wood -- I'm STILL relapse free since April 07. The LONGEST span of remission I've ever had since being diagnosed.

I'm lovin' it.