Tuesday, May 3, 2011

Novartis just called

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.


Testing out ScribeFire extension for Chrome

Copying my beloved blog from http://fty720.blogspot.com over to http://gilenya.blogspot.com has created the need for a tool that will simultaneously allow me to post blog entries to multiple blogs so as not to lose my old followers while I'm gaining new ones (that's you cue to click the follow link. Ahem! Did you do it yet? LOL)

Sunday, May 1, 2011

A Trip to the Fair - Part 2

While I was sitting there with bag of ice pressed to my goose egg I started shaking uncontrollably and felt like maybe I was a little bit in shock or something. I just kept saying over and over "Will somebody call an ambulance, please?!"

My son sat next to me sobbing because he thought it was his fault. I tried to tell him it wasn't and that accidents happen. While I was consoling him we were interrupted by a male voice saying "Ma'am, can you get up and walk to the vehicle?"

I was confused. Usually EMTs check you out a little or at least want to take a look at the bump before they go asking you to get up and walk around... I took the bag of ice off my noggin and looked straight into the face of a clown who was asking me to get into a golf cart.

I know it was dollar night but come ON! Surely they could do better than that!

The clown reassured me that the real EMTs would meet us at the back gate. Whew!

Sure enough the ambulance pulled up shortly after we got to the gate. They looked me over, asked a bunch of questions, shined light on my pupils, etc, etc. Then they loaded me up on a stretcher and shoved me in the back of the meat wagon and away we went. Upon finding out that my son was riding up front in the ambulance I told the EMT "That boy would do anything to get a ride in an ambulance! Why, he'd even trip his OWN MOTHER!"

I don't think the guy had laughed that hard in a while. I felt I had done my duty to supply comic relief to those whose jobs are otherwise thankless and stressful. These were some great guys and I appreciated everything.

Not long after were were under weigh I started having waves of nausea bowl me over. Worse than any "I-should-NOT-have-drunk-that-tequilla!" nausea or morning sickness I ever felt. Combined with my normal stage of dizziness, it was the worst part of all of it. They gave me this long plastic bag with a rigid circular opening at the top in case I threw up. I found out later it's a bag for male patients to pee in. Eeewww! Glad I didn't know that as I was holding it up to my face.

We got to the hospital and I had to go over the whole story again, telling the nurse and then the doctor how I tripped on thin air, stumbling over my own two feet. It was humiliating because I had deliberately told everyone I was with that I was NOT going to be riding any of those rides that upset your equilibrium because I didn't want to get dizzy and fall down.

Later my son said "See?? You should have just ridden the rides. You fell down anyhow and didn't get to have any fun." Out of the mouths of babes.. or in this case a smarty pants tween.

The doctor took one look at my noggin and ordered a CT. He said he hadn't seen anyone do that much damage just falling down in quite a while. I told him I was a professional and trained up north for it at a college near Niagra Falls.

I got butterfly bandages on a gash across my forehead and an awesome pill for nausea that totally erased it within 10 minutes, and with a clear CT they sent me home with a diagnosis of probable concussion.

I spent the next 2 days in bed, nauseous and tired... and the next MONTH with 2 black eyes in the shape of my sunglasses. I even had a black stripe across the bridge of my nose.

The eye doctor said they probably took much of the impact and kept me from breaking any bones around my eyes.

Here's a photo from 6 days after the fall. On the right side of the image, over my left eye, you can see some of the road rash that's healing up peeking out.

Before it was all over, my entire face from the eyes down had taken on a greenish tint. It was hideous.

Now that I look back on that day I do recall that it was hot out and I was starting to tire and the more I read up on it I wonder if I fell due to Foot Drop.

I've never actually had a doctor verify that symptom, but I do know that if I get extra tired or overheated I tend to stumble more and have a hard time completely picking my foot up from the floor/ground. I often stub my toes on the ground when I go to swing my foot forward taking a step. While I think I'm clearing the surface, my toes actually drop a little.

Maybe that's what happened?

At any rate, I have worn more darn makeup over the past couple of months than I have warn in the entire rest of my life combined.

My first black eyes ever.

The fair traveled onto the next town the following week and Karen, ever the joker, invited me to drive up there and go to it, black eyes and all.

Needless to say I took a pass on that one. Very funny, Ha. Ha.