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.
