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.

Nearing the end

I went for my checkup on December 1st. Just the usual blood draw, EDSS test, BP, HR, and one other thing I've never done before...

I filled out an application to a special drug program offered by Novartis for clinical trial participants. I had to provide my shipping address and my insurance information. Since I have no insurance that part was filled in with "None".

The rest of the form asked for my doctor to provide prescribing info and I was told the lead investigator would be the one to fill that out.

This form was supposedly faxed off to Novartis the same day and I should be receiving a call on my cell phone within a week or so gathering more info or instructing me on what happens next.

When the details have been all ironed out and I am guaranteed to be on a Rx and know how I'm going to get my Gilenya, then I'll be scheduled to have my Exit Exam.

The exit exam will include a skin exam, eye exam, PFT, MRI, EDSS, EKG, CT, BP, HR and probably a lot more ABCs I can't think of off the top of my head. Basically every test I had to take to get into the trial, I will be taking to get out of it too.

My clinical trial nurse said to expect this final exam (I have no idea how to cram for that) after the first of the year. I have more anxiety about leaving the trial that I had about getting INTO it. I know that sounds crazy, but things have gone so well for me and I have not relapsed in so long that the idea of leaving my comfy cage and exercise wheel behind to just be on my own with a new neuro is scary to me.

I'll be sure to document what happens with the application process as well as the Exit Exam for those of you in the trial who are curious about what happens next.

I'll keep blogging if you keep reading this drivel.

New Drug Appears To Overcome Resistance In Ovarian Cancer

New Drug Appears To Overcome Resistance In Ovarian Cancer

This is AWESOME news! I hope that clinical trials end up confirming that Gilenya / Fingolimod / FTY720 can fight ovarian cancer better than chemo. How many lives may be saved!

Apparently it was just MS fatigue

I've been back on the Estradiol for several days now with no issues. No fatigue like I felt those first few days where keeping my eyes open nearly required toothpicks.

I feel much better now -- back to my old self. That must have just been a blast of severe MS fatigue.

I have been fortunate enough to have been relapse-free for over 3 years now while in this TRANSFORMS clinical trial for FTY720 / Fingolimod / Gilenya and it's extension phase that I sometimes forget how bad my prior symptoms were. When I overdo it and symptoms like fatigue rear their ugly head, I am reminded that I do still indeed have MS.

Sometimes, but not too often because I don't like to dwell on the negative, I allow myself to wonder where I'd be disease-wise if I hadn't had the good fortune of this trial working out for me so well.

Anyhow, fear not the Estradiol. It, nor it's inert ingredients, caused the fatigue after all. Rather old age or MS must have done it.

Update on the Estradiol experiment

Today was inconclusive. I took a 2 hour nap, true, but I am not positive what caused the fatigue.

Today was Mom's birthday and my sister came over and took us all out to a local ice cream shop for hot fudge sundaes at noon. I'm not used that that kind of sugar overload midday. Typically that kind of sugar or carb intake will have me zonked within an hour.

So, I'm scrapping today as any kind of definitive test of the Wal-mart generic version of Estradiol and the possible fatigue inducing qualities of the inert ingredients.

Tomorrow I'll take the medicine again and try to make it a normal day as far as all the constants (like a NORMAL diet) go.

I'll report back when I've had another day to evaluate.

The Estradiol Experiment Continues

Since I last left you, I haven't taken my newly filled Rx of Estradiol any more after suspecting it was causing me extreme fatigue.

I spoke to a pharmacist who pointed out that although the Rx I had from Walgreens (that didn't make me tired) has the same active ingredient as the Rx from Wal-mart (which may as well be sleeping pills), the inactive ingredients may be what's bothering me.

I had too much stuff to do the past couple of days to risk zonking out in mid-chore for a 4 hour nap.

Today, however, I started back on the medicine at 9am to see what happens now. I was either a) MS fatigued, b) tired from having company, or c) adversely affected by the steroids inert ingredients**. We shall see if it was the medicine as that will be the only difference between yesterday and today. Yesterday I was not overly exhausted.

I wish that I had taken time to consider that today is Mom's birthday BEFORE I tried experimenting again. Family is coming over and I wanted to fix her a nice dinner. Hopefully the medicine wasn't the issue and I will be fine.

If not, I have already sung Happy Birthday to her and she'll be surprised with a nice Digiorno pizza tonight.

**PLEASE NOTE: I have no idea what possessed me to write "steroids". I haven't done any of those since 2007 and you probably are wondering where the heck that came from. I left it in place and struck it out, with the correct words coming after it so you won't think you were seeing things if you come back to read again. What was I thinking??

Blood Pressure Medicine and MS

How could this be a year old and I never saw it?

http://www.medicinenet.com/script/main/art.asp?articlekey=104764

A drug commonly used to treat high blood pressure may also double as a multiple sclerosis treatment.

A new study shows the inexpensive blood pressure drug lisinopril blocked development of multiple sclerosis in laboratory mice bred to develop the disease. And when the drug was given to mice with full-blown symptoms of multiple sclerosis, it reversed their paralysis without affecting their overall immunity.

Of course, big pharma probably was aghast when this news hit the wire. We CAN'T have a cheap alternative to the established DMDs! This would be unacceptable -- especially one that does not alter the immune system and comes in the form of a PILL!

Lisinopril is not without it's drawbacks, however...

SIDE EFFECTS: First doses of lisinopril can cause dizziness due to a drop in blood pressure. Lisinopril can cause nausea, headaches, anxiety, insomnia, drowsiness, nasal congestion and sexual dysfunction. Lisinopril should be stopped if there are symptoms or signs of an allergic reaction including feelings of swelling of the face, lips, tongue or throat. Severe allergic reactions (anaphylaxis) and hives occasionally occur. Rarely, lisinopril may cause a drop in red blood cells, white blood cells, and platelets.

Lisinopril can impair the function of the kidneys, and every person taking this medication should have their kidney function checked.

My first question would be: "That's great! But what does someone with LOW blood pressure do? Are they not a likely candidate for this type of treatment?"

I'm just amazed at all the different things, like LDN, CCSVI and now apparently this blood pressure medication that are being studied and what the ramifications might be for those of us with MS.

This is why it's so urgent that we do our best to help fund research into alternative treatments. Big pharma is not going to do it unless there's a billion dollar reason.

By the way, if you haven't done so, please go vote for the Pepsi Refresh Everything idea to Establish a Non-Mainstream MS Research Institute.

Estradiol update

Yesterday I forwent (is that a word? Okay, how about skipped?) my Estradiol in a little experiment of my own to see if it had any effect on the extreme fatigue I have been suffering for four days.

Turns out I needed no nap yesterday and didn't have that weighted down, someone-pull-me-from-the-deep feeling of oppressive exhaustion I had felt for the previous 3 days.

I had to go to Walgreens to pick up a few things and asked the pharmacist what she thought. I explained that I had been on a Walgreens-filled Rx of generic version of Estradiol for a month and had no issues, but then I went to Wal-mart and got their cheaper refill (it was hard to confess this but I did) and have had the fatigue issues since.

I did mention that I also have MS so I wasn't sure if that was the issue and it was just coincidental that I started having problems on or about the same day as starting my new bottle of pills.

Her response was interesting. She said that while the active ingredient was still the same, different manufacturers use different inert ingredients so there was a possibility that I was experiencing a side effect of one of them somehow.

I think I am going to wait until Wednesday to start taking the Estradiol again. I have an urgent need to be awake and alert for the next two days and don't want to continue my experiment until sleeping all day is an option I can afford.

I am very curious to see if I just had MS fatigue from company overload that required a few days to balance back out, or if it really is the new version of the same old pill causing me issues. If so, that sucks. The pills from Wal-mart are insanely cheaper than those at Walgreens. $17 for 30 days at Walgreens vs. $10 for 90 days at Wal-mart. When you're broke and have no insurance, those kinds of things matter.

Vote Now to Help Fund Research for CCSVI and LDN

My friend and former neurologist, Dr. Daniel Kantor has dedicated his life to Multiple Sclerosis. He is the singular most passionate person I know who stands as an advocate for those of us with MS.

His latest venture in pushing toward finding the ultimate Holy Grail of a cure is to try and get funding for a non-mainstream research center that will explore treatment options like LDN and CCSVI.

He is SO passionate about this project that he is willing to donate his own time to see this to fruition. Quote from the project notes:

Budget Notes: The budget will not cover Dr. Kantor's salary, which will be donated pro bono by him to the project. The budget will not cover services that we are applying for from in-kind donations. The budget will not cover administrative costs, which Neurologique will donate pro bono to the project.

I, for one, cannot see a better way for Pepsi to distribute it's Refresh Everything grant money, but you might say I'm a little biased.

Please watch the video below and cast your vote now before it's too late. Funding for research that doesn't necessarily have a goal of padding big pharma's pockets is rare indeed. We MS patients have a chance to take a proactive role and cast our vote to help better our own choices tomorrow.




So please take a moment and vote today!

http://www.refresheverything.com/neurologique

Estradiol and possible fatigue

Honestly, with the many and varied symptoms one can experience due to MS it's so hard to know what might be caused by something else.

My new issue, only to have reared its ugly head over the past 3 days is FATIGUE. OMG kind of debilitating fatigue that I have never had to this degree before. I have to admit that always in the past, when I'd heard of someone complaining of chronic fatigue and the fact that it ruled their life, I just couldn't comprehend. To me it seemed like maybe they should just get another hour or two at night and maybe they'd feel better.

Well, to all of you Chronic Fatigue Syndrome sufferers and anyone else out there battling falling asleep at the drop of a hat, my SINCERE apologies! I have now been indoctrinated in the ways of how the ocean of unconsciousness tries to suck you down and keep you from functioning.

We had family visit last week, but it wasn't like that should have affected me.They didn't stay at the house; they had a motel. They helped with cooking and clean up and even the shopping so the experience should have been a vacation for me rather than any kind of stress inducing event.

The day after they left, however, I took my son to school (the hour long round trip drive to the best school in the county), came home, fed the cats, made the coffee, told Mom I was going to lay down for a bit, and promptly crashed and slept nearly until it was time to go pick him up from school 6 hours later.

Chalking it up to needing to catch up a little on my rest, I just blew it off. That night I worried I'd be up all night, having slept all day, but I got my son in bed at 9:30 and had a hard time staying up long enough to do that. Next day, same scenario.

The weather here in Florida has recently turned cool (I'm freezing my ass off, if you want to know the truth, but I know a  lot of you readers would beg to differ that 45 or 50 degrees is "cold", so I held back). Driving my son to school is now an event that requires the radio to be on and the window to be halfway down. My son thinks I'm torturing him needlessly but once I explained, he was forgiving and understood. I don't want to succumb to the constant drowsiness that threatens to pull me down.

So what does this have to do with Estradiol you ask?

Well, I started on hormones a month or so ago when I found out I have Osteopenia in order to prevent Osteoporosis. I've had a hysterectomy so there's no worry of uterine cancer. I noticed immediately that many of my menopausal symptoms subsided after starting this therapy, among them hot flashes, night sweats, mood swings, etc.

My first batch was purchased at Walgreens and a 30 day supply cost me $17. My GYN told me that I could purchase the same med in 90 day qty at Wal-mart for $10. Sounded like a no-brainer.

I got the new Rx filled 4 days ago. I noticed right away the pills didn't look anything like my old ones. The new one is sort of a football shape with a line down the middle and a different shade of light blue from my old, tiny round pills.

Googling them I see they have different manufacturers but profess to be the same thing at the same dosage. I just tried to call the Wal-mart pharmacy to speak to a pharmacist but the phone rings off the hook, totally ignored, as I expected.

All I can figure is that these new pills have somehow activated my fatigue button. I have had this problem for as many days as I have been on the new refill of Estradiol. Last night I went to bed at 9:30, slept until 8:15am and then after lunch I laid down because I felt groggy and ended up sleeping from noon to 4:30 when John woke me up to ask if I planned on making any dinner.

I drank a glass of caffeinated ice tea and tried to pry my eyes open long enough to shake the grogginess and get some grub going.

I honestly don't know what's going on. I had just chalked it up to having too much excitement this past week, but when my mother suggested maybe it had something to do with my new bottle of pills it made me wonder.

Or maybe it's MS rearing its ugly head? If so, fatigue is the only new symptom I have so I seriously doubt it. I normally don't do single symptom relapses. I have to have big dramatic relapses as befits a hypochondriac.

I remember being a kid and fighting sleep and hating that I had to do it. Sleep seemed like such a waste of time. Now, as I sit here glazing over, all I have to do is think of my soft pillow and fuzzy blanket and I'm so tired I could just...........lay...........down...........nowww zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz

Doxycycline and MS

I know this is old news but something I have thought about for over three years now...

http://www.medicalnewstoday.com/articles/91379.php

While this was hardly a major clinical trial as compared to the trials with FTY720, I have had my own personal experience with Doxycycline and MS that, at the time, I was told by my neurologist was just a fluke. This had been prior to the article which was written in December 07.

Being allergic to everything from Penicillin to Levaquin, there are very few antibiotics that I can take. I had begun having symptoms of a urinary tract infection and, not being able to get it under control, I visited my primary care physician. He prescribed Doxycycline at 100mg twice a day for 10 days.

I was not on any MS therapy at the time and was in the midst of a relapse involving my legs being numb, burning and weak.

A few days into the treatment for the urinary tract infection I could have sworn I noticed a marked improvement in my MS symptoms. It felt to me the same way it does after steroids. Like something had tamped out the fire in my nervous system.

Next time I saw my neuro I mentioned this to him and he chuckled and told me it had to be coincidental that my MS appeared to improve while on Doxycycline. So that was that. I blew it off, never to think of it again until next time I had a UTI and needed it.

During the first six months of my participation in the TRANSFORMS trial of Fingolimod I had many UTIs as well as URIs. As often as once a month for that first six months. Each time I was placed on Doxycycline to treat the infections. Although I was not relapsing at the time, just the act of taking those blue capsules brought back the memory of how it had once seemingly quieted an MS attack all those years before.

Now don't go taking my word for this because I will tell you up front that I am not a medical professional and do not profess to be. I'm merely an MS patient who has her own thoughts on things and sometimes wonders them aloud here in my small corner of the internet. Should you chance upon these words, please take them as musings of an untrained observer.

That being said.... I wonder... ("here she goes", you say)

I wonder if what they concluded in the small study of 15 patients with active RRMS that stated "doxycycline, and other antibiotics in the tetracycline family, may help combat MS and other inflammatory diseases by slowing down enzymes that attack certain cells of the nervous system." might actually be true?

The sad thing is that we may never know. Doxycyline has been around since its development in the 1960's and was first marketed under the name Vibramycin by Phizer, Inc. It's a cheap drug. A 30 day supply costs roughly $22.

Compare that to the nearly $4000 that Gilenya is going for on www.DrugStore.com and you can see why there are no massive studies being done on the possibility of an old, relatively harmless antibiotic being used as a therapy for MS.

It's all about the almighty dollar, and investors, and breakthroughs that might lead to a well-padded bottom line, not necessarily to affordable treatment for all. Who cares about that? Let the government cover the cost for the uninsured poor folks who qualify and let the insurance companies pay for the rest. For those who fall between the cracks?

Well, unless we can traverse the land of patient assistance programs and beg for free meds, or meds at a reduced price, from the Almighty Drug Companies who bottle our future and hold out a greedy palm in exchange for Quality of Life, then we're basically screwed.

Too bad the world isn't a more compassion-driven place. Could you imagine a world where your possessions, accommodations, health and happiness were not solely based on the paper in your wallet? What if it were a compassion-based society. Where we did things for others because it was the right and moral thing to do. In return our needs were also met by other compassionate-driven people.

There would have been cures for cancer and MS and other horrible diseases long ago. Instead, we are a society driven by greed at the expense of others. There will never be a cure for cancer or MS or any other costly, debilitating disease or condition simply because the money is in the maintenance. Cure them and there's no more costly meds they have to have.

It's the same philosophy behind big tobacco. Hook your consumer and you have a customer for life. There's no way we are ever going to outlaw tobacco as the cancer causing carcinogen that it is. There's just too much money at stake. Too many greedy, unethical people driving the beast.

Big pharma has no reason to find cures. There's no money in a world rid of cancer or MS. And if you aren't happy about that they can help. They have a pill for that.

I'm not trying to take the wind out of the sails of the S.S. Gilenya by any means. This is a most wonderful pill that I am happy the world of MSers now has at their disposal. The only thing is, it's just a big tease for many of us. I am just appalled and ashamed of us as a human race that we have *evolved* to this. Charging outrageous fees for a medicine that has the potential to help so many. That's not evolution.

Don't argue that it was the biggest clinical trial in MS history and that there are so many costs to cover. Novartis will recoup those costs in the first year, I'm betting. Then after that, what is the excuse? That CEOs need bigger 3rd homes?

Or will the price drop? Ha!

 I remember being appalled at the cost of Copaxone back in 1999. $600 for a month's supply. Simply outrageous. I never imagined in my wildest dreams that the prices would skyrocket the way they have. When big pharma realized the gold mine they had in the *maintenance* meds, who was to put a foot down and stop them? The answer is NOBODY and that's why the pricing is out of control. They charge so much because THEY CAN.

There is no way the production of a powder in a gel cap costs as much as pre-filled refrigerate-at-all-times syringes costs.

Gilenya will be no harder to produce that Doxycycline, except that 100mg of the latter is a MUCH bigger capsule. I just hope I can continue to receive Gilenya which has been directly responsible for my good health these past three years and I don't have to resort to trying out my theory that Doxycycline might help me.

Do we really want to do something about the healthcare crisis in America? Start by getting the drug prices and costs of things like MRIs and CTs etc. under control. The crisis stems from greed. Meanwhile people suffer and die needlessly.

Taking a deep breath...

Ok, so the issue of cost of Gilenya has been weighing heavily on my mind for as long as I have been having such great results. I knew it wouldn't be as cheap as say my Estradiol (which I get for $17.99/mo) but was never expecting $48000/year as mentioned in my previous blog entry, either.

Thank goodness someone is thinking straight and had the presence of mind to call Novartis and try to get the info straight from the horse's mouth. The Queen put her foot down (see profile pic at link) and demanded to know the one true answer. Here's the queen's comment from the last post (in case you don't want to bother with all that clicking and scrolling):

I read a little more on this today [regarding the topic of my last post], and the person giving the info has no relationship with Novartis, he's just a stock market analyst commenting on stock. He says Novartis could charge as much as $40,000. Well, they could. Doesn't mean they will. I called the Gilena line and the woman there said two things: 1)she couldn't give me the exact price and 2) she suggested Novartis has a very generous assistance program if I couldn't afford it. I started to laugh and asked,"Do you know of anyone who could afford to pay over $100 PER PILL?" and she laughed. I was encouraged after I spoke with her.

I suppose that's why she's The Queen, taking that logical, level headed approach and all. Thanks for calming me down.

So, here's my plan. I got a link in a Google Alerts email I have set up, and found that Novartis has launched a brand spanking new website for their baby: http://www.gilenya.com/index.jsp .

I signed up to be updated on new information and to allow them to contact me. During the sign up process, one of the questions asked was about the current therapy I was on. One of the choices was Gilenya. They then asked how long I had been on it, giving me several choices to choose from -- 3-4years being among them.

This tells me that they are interested in contacting us lab rats and getting our input on our personal experience. I found that interesting. If they call I may just direct them here and tell them to start from the beginning. Make them work for the info. Muahahahahaha.

Also at their website is a pdf of the:

MEDICATION GUIDE
GILENYA™ (je-LEN-yah)
(fingolimod)
capsules

Here's the link: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya_pmg.pdf

I just noticed, while reading what I have copied/pasted above, that once again I have already been mispronouncing a medication name.  "je-LEN-yah" sounds even stupider than the "gill-EEN-yah" I had been saying. Oh well, maybe that's Swiss for "cure". Hopefully not for "suck you dry of all you money and worldly possessions."

There is a phone number, address and email listed to contact them regarding je-LEEN-yah and without further ado, here they are:


1-888-NOW-NOVA (1-888-669-6682)
Monday - Friday, 8:30am - 5:00pm EST

Customer Interaction Center
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080

Email (actually a contact form):
https://www.gilenya.com/jsp/utils/contact/info/emaili.jsp

I plan on calling them Monday to pick their brains and see who I need to kneel before and beg for free medication for all of the test subjects (and here's the kicker) REGARDLESS of income or insurance coverage.

I have heard stories among the various trial participants of some of us getting reimbursed travel money for getting to testing sites. Not only have I NOT gotten reimbursed, I have been billed many times over for tests performed as part of this study, with the ophthalmology department being the most consistently guilty of this practice.

I know I read the informed consent and agreed to their terms that I would not reap any benefits beyond the possible health benefits due to the medication, but I'm talking about the morality and compassion of the issue here.

I think congress needs to be lobbied on behalf of clinical trial patients everywhere to make it a law that if a medication gains FDA approval those who risked their lives in the name of medical advances should be granted free access for life to that medication regardless of their financial status or insurance coverage.

If this were law, you might even find that the attraction of joining a trial would increase and there would be even more test subjects available to expedite the advancement of future medications.

I don't know how to go about lobbying for this, and maybe there aren't that many folks who agree with me or would be as passionate on the subject, but there MUST be someone out there who either knows, or knows someone who knows, how to go about turning this into one of those made for TV movies based on a real life drama and get the action needed to see this as more than a pipe dream (or pipeLINE dream, get it?) and have it be reality.

I truly believe everyone has a purpose in life. Our mission is to discover it and see it through. Maybe I have finally found my calling. Anyone with me on this?

Here is a formal call out to anyone out there who knows how to get started on this. Please leave a comment with your thoughts and any info that could point me in the right direction. In the meantime I'll go google how to get a law passed. I knew I should have paid more attention in Political Science class.

HIGHLIGHTS OF PRESCRIBING INFORMATION FOR GILENYA

http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf

Here's the highlights from the prescribing info sheet for which we all got poke prodded and inspected to provide the data.