The new spot...

Come join me over here so I can quit posting in 2 spots. Since Novartis decided to change the name of the drug from Fingolimod to Gilenya, I redid my blog and have a new home for it. So far only a few followers, so if you follow here, come follow there and I'll quit trying to post in both places.

http://gilenya.blogspot.com

See ya there!

Starting a weight loss plan and feeling better

I started the TRANSFORMS Fingolimod (now Gilenya) Phase III trial way back in August of 07, and one of the known side effects of the drug was a slight asthma-like breathing issue. While this wasn't necessarily a given that I would have that happen, they did say they were going to do a pulmonary function test every three months.

This frightened me, an admitted hypochondriac, into quitting smoking cold turkey on the 4th of July, 2007 prior to my entering the study.

Why mention all this? Well because up until that time the only times I had been overweight in my life were the two times I was pregnant with each of my boys. But that didn't really count. Not even the second time when it took more than a year to shed the "baby weight". 

Then I quit smoking and the gradual change happened. It happen SO gradually that it snuck right past me and packed the weight on my backside while I wasn't looking. Well, if I had looked down at my gut I may have noticed, but I was in denial... right up until I went shopping for a new bathing suit since we got season passes to Wild Waters in Silver Springs, FL. After forking out that kind of dough I am not ABOUT to not go due to having no suite.

I ended up having to get one that hid my rolls as best as could be expected. It's black with bright paint splatter pattern in hot pink, yellow, green, blue, etc... a sort of old lady's camo. And the bottoms are swimming shorts, no T-back for this rump. I wouldn't subject anyone to that.

So I'm realizing that quitting smoking was actually EASY compared to losing weight. My philosoply that has worked so far with smoking is, "just never do it again and you won't ever start back up."

I'm finding out food doesn't work like that. How cruel. I have to actually make a conscious choice every time I eat something. Is this the best choice? Do I really need to eat it or why am I eating it? Boredom or hunger?

I'm making a little headway and not back sliding much, but it's hard, and I"m not seeing instant results like I did when I quit smoking. My clothes aren't getting any tighter, but they certainly aren't noticably looser yet. 

I've had a couple spells where I wasn't able to get my next meal in a reasonable time period and I got hot, sweaty, shaky, and dizzy. Almost feeling like I was going to pass out. Eating something sweet or carb laden seemed to bring me right out of it.

I'm wondering if maybe I have made too many big changes in diet and fitness to suddenly for my 50yo body to handle.

Anyhow, at least I'm not contending with MS symptoms. What a great relief. I am STILL, after nearly 4 years on Gilenya, astounded every day that I have yet to relapse. I thank God I have a life now. Prior to the study I was suicidal and all consumed by the terrible symptoms that had zapped me of my will to go on.

Seems like I should be doing something meaningful with my time since I have been granted the precious gift of near normalcy... but right now I'm concentrating on trying to shoehorn myself in that bathing suit and not burst the seams when I'm going down the slides at the water park.

Sorry to say I'm not writing an everlasting piece of literature that will become a classic that endures time. And I"m not finding a cure for cancer.

I'm just trying to spend some quality time with my family and that is enough accomplishment for me. :) 

The Muffins Win

I give up. I found the best recipe for Golden Raisin Oat Bran Muffins and the very first time I made them they were to die for. Awesome flavor, tender texture, heady aroma right out of the oven.

And EVERY time I've made them since then, I've screwed them up. Today was no exception.

I ran down the list of ingredients, deliberately checking them off once I made sure I had each item AND in the appropriate quantity. These muffins weren't going to get the best of me this morning, by God!

Everything went perfectly - I even remember to get the melted butter out of the microwave this time. (Last time I made them I only discovered the butter about 10 min. after the pan of muffins had gone into the oven. That batch was a little....rubbery).

Then came my fatal mistake. I thought I could be like Dad and improvise. Dad was a great all around cook and baker. He had many many winning recipes that could never again be duplicated because he had used no recipe or had improvised so much as to have eclipsed the original instructions.

 I live in Dad's house now, keeping Mom company and trying my  best to feed her in the manner to which she had become accustomed when Dad was alive. He's been gone a decade now and lots of stuff remains behind that reminds us all of him...

...including, I suspect, the bag of pecans I found in the back of his flour cabinet which I attempted to use in my muffins this morning. Bad mistake.

Everything had gone so smoothly up to that point that I must have gotten cocky. I wanted to add something "extra" that the recipe didn't call for. I had successfully done this on my second attempt at making these muffins and while they were rubbery from lack of butter, the pecans were slightly redeeming.

I grabbed the bag of pecans thinking they were probably purchased in the past year or two by one of the many family members who regularly use the kitchen when we have holiday get togethers. Just because I didn't personally remember purchasing them sent up no alarm bells.

Neither did the musty odor of the nuts when I opened the bag.

In my own defense I did look at the front of the bag again to make sure it said "pecans" because I didn't remember them smelling like that.

I don't have any self confidence when it comes to cooking or baking, though, and I always think the ingredients know themselves better than I do, so maybe pecans had every right to smell that way.

Turns out that odor carried through the baking process and even blossomed into a more pungent odor -- and flavor.

Mom, bless her heart, was the first to take a bite and, ever the Encourager, she managed a "tastes good!" while she gagged it down.

My son was next and had no problem spitting it out immediately accompanied by an "Oh my gosh, Mom! What did you DO to these?? They SUCK!" He immediately grabbed a handful of graham crackers to get the taste out of his mouth.

I scolded him for being such a harsh critic while I was peeling back the paper to take a bite of my own muffin...which I immediately spit out.

We both tossed our muffins to the squirrels out back who didn't seem in any too big of a hurry to scarf them up, and headed back to the graham cracker box for tongue wipes.

I tried to tell Mom not to eat any more, but someone who lived through the Great Depression has a hard time parting with perfectly good food even if it's "a little off". She ate around the nuts. How you do that is beyond me.

So, if you are in the market for a wonderful Golden Raisin Oat Bran Muffin recipe, here is the link to it:

http://www.epicurious.com/recipes/food/views/Golden-Raisin-Oat-Bran-Muffins-357450

but it may be a while before I attempt it again. If I keep on screwing these up we will all have a knee jerk gagging response to the very mention of muffins in this house. I knew I should have gone with the chocolate chips over the nuts when I was debating. You can't screw up chocolate chips.

And actually...they tasted pretty good the first time when I just followed the recipe and didn't try to emulate my father. I did NOT inherit his improvising genes or they got severely mutated along the way.

 

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)

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.

A Trip to the Fair - Part 1

The azaleas are in bloom here in North Florida, ushering in the springtime. One of the annual events is the Putnam County Fair which we always try to attend but usually something comes up and we don't go.

This year was different. A year and a half ago I reconnected with my best friend at, of all things, her husband's funeral. I kicked myself for letting the time -- nearly 20 years -- get by us, and I regretted losing out on spending time with them both when they were a happy couple.

So now, with my perspective changed, I am trying to do things before it's too late. Even the little things are important. No more "there will be time for that later" as we all know that later may not come. And nobody lays on their death bed wishing they'd worked more. No, they regret that they didn't spend more quality time with the kids and grandkids.

So, with that goal in mind, I DID go to the fair this year by gosh! And I went with my 12 year old and my rediscovered friend, Karen, and her great neice and great nephew. It was dollar night and all we needed to do was bring 1 canned good donation per person and entry into the gates was just $1 a head. All rides were also just a buck.

The kids kept encouraging me to go with them on all these rides that whipped you around and turned you upsidedown, but I was content to be there living vicariously and watching them have all the fun. The smiles and laughter brought joy to my soul.

We walked around the park and let the kids ride all the rides and play all the games while Karen and I reminisced. At one point we were in the back corner of the fair, looking out across the entire event. The glow of the setting sun bathed the screaming, laughing crowd in a golden glow and all seemed right in the world.

I said something like "this day couldn't be more perfect!" and Karen said "Used to be I'd come to the fair and see so many people I know. This year I don't see anyone. It's a shame to say, but nowadays if I want to see people I know I have to go to the hospital."

Since losing her husband over a year ago it seems like she's spent all her free time nursing her loved ones with no time for grieving her own loss. The remark about the hospital was funny, but true.

At that moment the kids got off a particularly crazy ride that had spun them silly and they were staggering all over. My son, who leans toward the dramatic, was overacting it a bit and stumbled into me causing me to, in turn, stumble before I caught my balance. In a cross voice I tell him "Hey! Be careful! I ALMOST FELL!"

My heart pounding in my chest from the near catastrophe, we turned and headed  down the fairway toward our next ride. It was maybe all of 10 steps later that it happened.

My hands were involved in the task of digging for ride tickets in my purse which was hanging from my shoulder when my left toe came to a stop on my leg's forward motion. For anyone that has tripped in their life, they know that utter panic that instantly hits you when your gait is suddenly interrupted and there is no recovery, and not really even any planning time for the best way to minimize your impact. It's no different than being strapped into a ride at the fair and knowing you made a horrible mistake thinking you could handle The Zipper this time. You just ride it out until it's over.

I sort of flew horizontally for a brief moment before my left knee impacted the blacktop, followed almost instantly by the left side of my forehead. I remember it made an amazingly loud "CRACK!" sound and my glasses flew off my face.

The first thought I had was being angry because I paid a lot of money for those bifocals, but then I remembered I had been wearing sunglasses. Whew.  It's funny what stupid things you think about at times like that. (well maybe it's just me.)

My son came running up screaming "MOM! MOM! Are you ok???" and my friend Karen turned around, not having seen me go down, and immediately panicked thinking it was my MS. Since we have been reunited in our friendship, she's not had the pleasure of seeing what an MS attack does to me and did not know that normally it's more gradual than that and would not put me unexpectedly flat on my face.

So there I lay. Next thing I know, some guy who saw me fall came running over and was helping me up. When I lifted my face from the ground I heard a collective gasp from everyone around. I reached for my forehead and was surprised to feel a huge goose egg there. When I pulled my hand back it was covered with blood. Eeeek!!

THAT'S when I started to freak out. Karen and the stranger both helped me to a bench just feet away where I sat cupping my goose egg and shaking uncontrollably.Karen ran to get me some ice and I could hear people shouting to call an ambulance.

It seemed like everything was moving in slow motion. Karen gave me a bag of ice that I pressed to my head while my son sat sobbing beside me. I was confused about what happened and had initially scolded him again for tripping me. He said he didn't think he did, and after reliving it again in my mind I realized he'd been behind me to my right and there wasn't really any way he could have done it. No, I had just tripped over my own two clumsy feet.

(to be continued...)

It's finally over!

Wednesday and Thursday (the 19th and 20th of Jan.) were a blur of testing. Novartis wanted things wrapped up for the TRANSFORMS trial by January 20, 2011 and the folks at my location were giving it the ol' college try.

Wednesday I had my final dermatology exam and as usual I came away with a bandage on me. I have suspected since my very first visit when 3 beauty marks I'd had all my life remained behind in a specimen jar (or on a slide or whatever they do with that stuff) that this was a money making proposition. In the four visits I'd made to the facility, I lost 5 moles and one angiolipoma. None of them were anything to be worried about.

As if to confirm my suspicions, when the new doc (from the same group) couldn't find anything remotely suspicious to cut off, he reviewed the clinical trial paperwork they'd been provided and said "They'll pay for up to 3 removals per year... is there anything you want removed?"

Instead of explaining to him that technically that was supposed to only be IF the moles looks suspicious, I just pointed to this gigantic mole on my neck I'd had all my life. I'm sure it's the cause of my early-onset low self esteem and I decided with my birthday looming I'd just go ahead and treat myself.

He said "you've got 2 more coming for free... anything else?" When I shook my head he turned to his nurse and said "Just numb her up for that big honkin' one then."

"HONKIN' ONE??" I asked. "Is that medical terminology?"

Ah to be the brunt of a funny joke! Anyhow, to make a long story short, the big "honkin'" mole is gone and in it's place is a big honkin' scar. Oh well.

Next day I had my EDSS test and had to deal with the recorded man asking me to add numbers. This time I ACED it. Not a single wrong answer. Just the way I'd planned -- to go out on top.

I also had a PFT, EKG, bloodwork, eye exam and a MRI that day to wrap everything up.

When it all was over, I gave back my last 3 bottles of trial medication however wistful that I would like to have kept one for a souvenir. In return I was handed my first 30 day supply of the commercial version!!

I applied to their assistance program and qualified to get my Rx FREE for a year. After that, I'll have to reapply. As long as I stay indigent like I've been all my life, I'll be okay. What a plan.

If I win the lottery, I'm screwed.

Anyhow, it's been a long strange trip and I am so very grateful to have had the honor to be a part of it.

If you want to keep reading I'll try to remember to blog, but it may just be about me and not the drugs now. I'll keep reporting how I'm doing but since the trial is over I won't be blogging my checkups.

Thank goodness because the dermatology group would have whittled me away to nothing before long.