Rather than troll the internet for new information which could possibly be inaccurate, I had a brilliant idea. I called my study coordinator to get the info straight from the horse's mouth.
You may recall that she is the one from a foreign country and speaks with a beautiful accent which is mesmerizing and I blamed not hearing my correct appointment date for my last visit on the fact that I was busy listening to her voice.
Well, today I paid attention to every single word.
I called because someone had posted on the MSWorld message board that there have been 2 deaths. That was news to me.
I told the coordinator that I was concerned and to please tell me all that she knew.
Here is what she had to say:
One patient has contracted viral encephalitis and she is now in a coma.
The other patient had suffered a MS relapse and was put on steroids. She returned to work at a day care facility before it was recommended that she do so. She contracted chicken pox from a client. Due to her immune system being further compromised by the use of steroids, she ended up dying.
They are not at this time going to halt the study or the extension phase.
Tomorrow, Thursday June 12, they will be having an online conference where Novartis is going to communicate with all the involved study centers at once to inform them of any updates to the info that they have gathered concerning these two patients, and they will instruct the study coordinators as to any new protocol they may have.
Both patients had been on the study drug for nearly a year, starting this phase III trial in the summer of '07.
Novartis has not released whether these patients were on the Fingolimod or Placebo or Avonex.
My study coordinator was unsure whether they were both in the TRANSFORMS study or a different FTY720 study. The TRANSFORMS study has no placebo. You are either on Fingolimod or Avonex.
My instructions were to not worry, be vigilant about any infections I may get and inform the study nurse/neuro about them.
She reminded me that I had suspected I had a UTI last year and had mentioned it to them and they started me on Doxycyclin right away -- even before getting the result of the urine test back. Turns out I was right, I did have a UTI. She said THAT is how I should always approach any type of new thing I become aware of...to tackle it head on, right away, and not take a wait and see stance.
I asked that she please call me if she finds out any new info after the conference tomorrow as I am very curious, having a huge stake in this.
So...I'm back to thinking only good thoughts and trying to forget that there are risks with everything we do in life. The benefits still outweigh the risks for me. I'd rather have a fantastic quality of life and die suddenly than have a terrible miserable existence and live to be 100. So far this study has given me my life back and I'm still not ready to give up on it!
If I get any calls from the study people and have any more info to share, I'll be sure and post it.
7 comments:
Well, I'm sorry to have caused you any undue stress, and I feel a bit like Chicken Little, but Herr Doktor did tell me the coma patient died. I was reading the reports along with him and the viral encephalitis man was on the 1.25 dose of Fingolimod. I didn't see what day care lady was on.
It was not a cheery visit today - he also gave me the rundown on other non-lethal serious events experienced by some patients. There were a couple of cancer cases (of course, that could be caused by anything) and one heart condition that will require a pacemaker.
Dr. K. doesn't think that Novartis will can the extension phase based on these cases, but I guess we'll all know more after this conference call.
I'm with you - I've only had one relapse since being on this trial, and I LOVE that it's an oral med. I hope everything continues to move forward.
Hmmmm maybe the coma patient died since my study coordinator was last updated! Being in a coma is bad enough even if they haven't died.:(
Don't worry about the "undue stress". I have a habit of combing the internet and stressing over everything I find. It's nothing personal -- I'm an admitted hypochondriac. LOL
So the one in the coma was on the higher dose of F and we don't know what the day care lady was on. See? I didn't even know the coma patient was male.
I knew about the cancers, didn't know about the pacemaker.
If you find out anything about the conference call do please post back and leave a comment about it. I'm all ears.
I am GLAD you posted on MSWorld. It gave me the kick in the butt to go call the trial lady which is what I should have done on the 5th when the sh*t first hit the fan with all this.
We Fingo-heads have to stick together. If I find anything out, I'll let you know.
I don't even care that this is an oral drug...I am just thrilled that I've not had even one relapse in over a year now. (13 mos.) If it were a shot I would still be thrilled to be on it....of course, the fact that it's a pill is icing on the cake. :-)
What center do you go to? Is Dr. K. in Jacksonville? Just curious since I also see a Dr. K. LOL
Hey, Pinkie!
You are my source of information and inspiration about FTY720...I was getting my Tysabri yesterday and a woman who USED to work with my previous neurologist (and ran the Rituxan study I was in) NOW works for my current neurologist. She popped her head in my exam room to say "hi"...one thing led to another (she's running the FTY720 study for Dr. SWWNBN)and I referenced your blog. I just cut and pasted THIS post in an email to her as she had heard NOTHING about this!!!
Do keep us informed (as I watch like a voyeur from afar).
Linda D. in Seattle
I go to USF in Tampa. I can't WAIT for no needles. Not that I'm a needle weenie, but my skin reacts to just about anything it comes across. I had to stop taking Copaxone because of the hives it gave me. So I <3 the pills...
I will definitely let you know if I hear anything new.
When I went in for my appointment last week, I really wasn't sure how to react when the research coordinator told me a 29 yr old died and a 24 yr old was in a coma
I was told that if I did relapse, they probably wouldn't give me steroids.
I've been in the extensions phase since April. Last week my blood results were shown to me. My white blood cell count is way down, as is other things.....it really makes you think
Hi girls! Eventhough more than 6 months has passed since the last post, I would like to share my experience as well. I was on Fingolimod and I got out by mid October reason being that I was feeling worse than before and also because my white cells count dropped dramatically. I also very concerned by the way Novartis handled the situation regarding the 02 deaths. Actually, i brought the news to my study coordinator on the same day Novartis did. I was under the impression that I was taken the 1.25 dose because of the side effects that I had. But the goods news is that the 0.5 dose seems to be efficient than the 1.25 and Novartis will push for approval of the 0.5 by the end of this year. Keep your fingers crossed ;))
my husband is in an induced coma right now and has a brain infection. he was on fingolimod for 6 months. 1/8/10
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