A few days ago I participated in a survey about my experience so far with Gilenya. This was by invitation only and was geared toward individuals who had just started taking the newly approved drug.
The fact that I was a clinical trial participant for over 3 years made some of the questions hard to answer. Like they wanted me to remember back that far. And questions about my biggest concerns on the first dose day. Well, my biggest concern (being that I was in a trial that blinded you to whether you'd be getting the real Gilenya or if I'd be taking Avonex) was that I was getting the real shot and going to suffer flu-like symptoms. Not your average response from someone just starting the commercially supplied version.
Sometime during the interview I must have shared the fact that I had multiple URIs and UTIs during the first 6 months which later subsided.
Ding! Ding! Ding! The alarm at Novartis HQ must have sounded and they saw the Bat Signal and raced to the Batmobile to get to a pay phone to call me.
A really nice man called and said he'd heard I'd had URIs and UTIs and wanted to know what my start date was. When I said Aug. 20, 2007 he just sort of paused before the light dawned and he said "oh, so you were in the clinical trials?"
I still had my participant ID card in my wallet -- right there with the picture of my grandaughter -- and I whipped it out and read off all the info about trial location, lead investigator, study number and even my patient ID number which was "0008". I told him I missed being Double-0 7 and ended up Triple-0 8.
He said they must follow through on any and all reports of adverse events to be sure they are documented properly.
I told him to go for it. If that's what makes their day is to look back over my whining about my congestion and how my pee burned, then have at it.
I know it's important that they do this stuff, and that they follow up on any and all reports of side effects but really you would think they could look in their records before the survey and know they already have three 5" binders FULL of documentation.
I don't know if I got a picture or not but it was just crazy how much paperwork is involved in a clinical trial. I saw the binder once and asked if that was for all the patients at that study location and she replied "No. That's just ONE of YOUR binders. There's 2 more like this one the shelf." My jaw dropped.
So if you had a survey regarding starting Gilenya and said anything about any side effect, no matter how slight, be prepared for a phone call.
Actually, after all the fiascos with past MS medications and unexpected adverse events, it's assuring to see Novartis actively staying on top of things and continuing to monitor and gather information. It makes me feel confident that it anything negative arises we will know about it quickly.