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


  1. Excellent reference to Flowers For Algernon. I want to cry if I just think of that book.

  2. Same here! I was just unblinded and I'm on the lower dose too! Happy to be continuing on. I hope Novartis needs us to stay on trial for a long time to give long term results.

  3. Me too!!!! I'm also on the lower dose. It's weird finally knowing.

    the whole year of needles.....and they were filled with saline.....

  4. Ashley, that was my very FIRST thought... all those 2" needles jabbed in my thigh for absolutely nothing.

    Then I thought of how I didn't have any Avonex type side effects and was happy it had been water. LOL

  5. Hello darlin'. I just stumbled on to your blog. I work for Novartis and we just recently submitted the application to the health authorities for approval. It's very nice to read a personal account. Helps balance out all of the hard work, and very long hours!!! Congratulations on doing so well!!!

  6. I've been wondering how this trial would turn out -- I learned about fingolimod back in 2004 while doing research for another project. It's great to hear that FTY720 has actually turned out so well.


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