Fingolimod and Me

The new spot...

2011-06-17T22:04:00.002-04:00

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

2011-05-24T16:15:00.001-04:00

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

2011-05-15T10:37:00.001-04:00

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

2011-05-03T13:48:00.001-04:00

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

2011-05-03T11:28:00.001-04:00

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

2011-05-01T12:22:00.000-04:00

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

2011-04-25T09:14:00.000-04:00

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!

2011-01-31T14:09:00.000-05:00

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

2010-12-05T12:17:00.000-05:00

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

2010-11-15T21:35:00.001-05:00

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

2010-11-15T08:50:00.000-05:00

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

2010-11-11T16:03:00.000-05:00

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

2010-11-11T10:13:00.001-05:00

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

2010-11-08T09:34:00.000-05:00

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

2010-11-08T09:04:00.000-05:00

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

2010-11-07T07:27:00.000-05:00

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

2010-11-06T19:41:00.000-04:00

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

2010-10-13T11:47:00.000-04:00

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...

2010-10-02T08:13:00.000-04:00

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

2010-10-01T11:33:00.001-04:00

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.

Gilenya to cost $48000 per year!!

2010-09-30T20:45:00.001-04:00

Holy CRAP!

http://www.bloomberg.com/news/2010-09-30/novartis-gilenya-ms-pill-to-cost-48-000-a-year-update1-.html

What I want to know, oh You Who Run Novartis Yet Do Not Yourself Suffer From MS, is how you people can sleep at night.

Give us a pill which will change our life -- mind you NOT CURE MS so we can be done with it, but merely give us hope and ease our suffering in such a way as to make us Fingolimod junkies for life -- and then try to make us pay $4000 a MONTH for it?? I KNEW when I saw those souped up pill container prototypes in that survey I was asked to take that you would be pulling this. Didn't I say just that?

This really ticks me off. It's the height of greed. I realize the trials were huge and cost tons of money, but production is going to be cheap. There are no syringes to supply, no medication to keep refrigerated. You know as well as I do that you will recover your testing costs within probably the first year on the market. This is just OBSCENE! I can't even begin to put into words how disappointed I am.

Do you think people with MS are just all rich or something? How dare you take advantage of our condition that way. To bring a pill to market -- sure, so you can profit, I get the goal -- but to make it so astronomically priced as to only be a cruel tease for those of us who can't afford it.

It was mentioned in the article that there are assistance programs for those who can't afford it. Well here's a novel idea you can do a clinical trial about... see how much further your drug goes to help people when you price it affordably to start with.

It's human nature I guess

2010-09-25T23:26:00.000-04:00

Ever wonder why the nightly news is always negative? Why we will zip right by an amazing sunset, but give us a good car wreck and we are slowing down to take in ever gory details? I guess it's only human nature to be fascinated with the ugly side of life.

I went to a message board for people with MS. Anyone who's had MS for any length of time has been there, I'm sure, as it's probably the biggest one for our condition on the web. I used to hang out there quite a bit back before the trial started, and even well into my first year of the study.

Then one day I realized there is life outside of MS and I was feeling so much better on the Fingolimod (ok, ok Gilenya) that I wasn't dwelling on my condition as much as getting back to the business of living. Once I broke away from that message board my head became more clear and my depression started to lift. I attributed it to the medication and the relief of finally having the relapses subside.

Well, yesterday I went back to visit and see if anyone was talking about the pill. I mean, I'm so giddy with excitement that I just had to see what folks were saying. I found a thread where the mention was made of the drug getting approval, and while most folks seemed hopeful, several others were quick to point out the serious side effects.

I was overcome with an urge to let everyone know just how much good it has done for me, so I posted.

Imagine my surprise and hurt when someone responded that they were tired of hearing good news and wished someone who'd had side effects would post.

Really?? Good news about the long anticipated PILL FOR MS was something they didn't want to hear?? I know I'm Novartis' #1 fan and I feel I owe them my very health as I know it today, but they ain't payin' me, people. This is real and it's my genuine experience. I haven't been blogging for the past 3 years just to string you along and lure you in so Novartis can finish you off with their pill. True, your mileage may vary, but come on! I"m not the only one out of the 1250 or so trial participants (in what has been touted as the largest clinical trial for MS EVER) to have a positive outcome.

What? My experience ALONE got the FDA to say "ya know, that patient #008 at that Florida location seems to have done really well. Ah, what the hey, let's give it a rubber stamp and call it a day."

I'm not buying it.

Especially after the Tysabri fiasco, don't you think they are crossing t's and dotting i's these days when it comes to immunomodulating drugs??

So I left a comment saying I was sorry to have been the bearer of good news and that I didn't realize they weren't looking for that.

I won't be going back. I know that a lot of great folks are there and that there is a lot of suffering going on and people looking for camaraderie, but there is also a lot of negativity. I don't need that in my life.

There are too many beautiful sunrises I want to pull over to watch. I'm not stopping to see the train wreck, and if you wanted me to tell you about it I guess you'll just have to wait for the evening news instead.

Today is the day!! The FDA Approves Gilenya (Fingolimod, FTY720)

2010-09-22T17:15:00.001-04:00

I had been watching closely all day yesterday for the mention of approval, but went to bed broken hearted.

Today was a mad house of domestic flurries and I forgot all about checking the FDA site. I even forgot to check my email all day until just now.

How fitting it was, then, that the first email I should happen upon was that of my clinical trial coordinator. She sent no message but rather a link to an article announcing the FDA approval.

I'm elated, excited, overjoyed and nearly in tears about this news. Whether tears of joy for all who have been awaiting the pill, or tears of sorrow as a chapter in my life will soon be ending and I will once again have to figure out how to pay for my meds, I'm not sure.

I feel like jumping up and down and I don't know why there's no fireworks when I look outside... surely it will be on the evening news, right?? I mean this IS BIG! The first EVER pill for MS. Wow! And I've been on it for 3 years already!

Anyhow, here is the news straight from Novartis' mouth:
http://www.novartis.com/newsroom/media-releases/en/2010/1445917.shtml

And another link on Bloomberg Business Week:
http://www.businessweek.com/news/2010-09-22/novartis-awarded-u-s-approval-for-ms-pill-gilenya.html

I guess I have to get used to saying "Gilenya" now. Took me forever to learn to spell Fingolimod. Thanks Novartis.

Really, though... THANKS NOVARTIS!! -- and CONGRATULATIONS! You gave me my life back one pill at a time. I wish you much success with lots more MSers out there.

We Were Beaten to the Punch! Russia Approves Fingolimod!

2010-09-10T19:19:00.000-04:00

Russian Authorities Become First to Sanction Novartis’ Oral MS Therapy

GEN news highlights: Sep 10, 2010

Russian regulatory authorities have approved Novartis’ Gilenya® 0.5 mg once-daily oral treatment (FTY720; fingolimod) for relapsing remitting multiple sclerosis (MS). Russia is the first country to approve the sphingosine 1-phosphate receptor (S1PR) modulator, and Novartis plans to launch the drug in early 2011.

An FDA decision on Gilenya is expected during September, and the outlook for U.S. approval looks promising, given that the agency’s advisory committee gave the drug a unanimous thumbs up back in June. Gilenya is also under review by the European Medicines Agency and by other regulatory bodies worldwide.

Novartis says Gilenya is the first oral therapy for treating relapsing MS. The Phase III trial program confirmed the drug reduces relapses, disability progression over two years, and brain lesions. Data also showed Gilenya to be more effective than Biogen Idec’s Avonex®, the firm adds. The FDA granted Gilenya priority review status in February 2010, reducing the standard ten-month review to six months. In May, the FDA extended the priority review period by three months to September 2010.

================ ~*~ ================

Aside from the fact that I believe they spelled Gilenia incorrectly, this news gives me chills. This wasn't a dead end, waste of time study (not that I thought so, but I remember my hesitancy when presented with the Clinical Trial option for trying out therapy). It's really coming to pass.

They beat us by 11 days. But it's coming. I expect ticker tape parades, special treatment, and paparazzi everywhere due to the fame we are all going to have once this thing takes the MS world by storm.

Reality check: ticker tape parade is when the paper shredder goes haywire, special treatment comes when you get phone calls from bill collectors asking for you BY NAME! and the paparazzi is just someone in your family catching you having a bad hair day and deciding for some reason that it should be recorded for posterity.

I can be famous if I try hard enough... see?

GOOOOOOOOOOOOOOOOOOOOOOOO Fingo!

The News I Received at my TRANSFORMS checkup 22

2010-09-09T21:01:00.001-04:00

I didn't mean to leave you hanging -- I really did intend to finish this up, but life got in the way.

Anyway, while I was being examined by the head neurologist overseeing the study in my area, he mentioned that everyone is excited that Gilenia is on track for FDA approval to be announced on the 21st of September.

EEEEEK!! That's too soon. (Sorry to those of you so patiently waiting, I just had to have a selfish moment).

Actually this is amazing news and I am so very excited! So was the neuro. He said "After all this is over, and history is made with this new pill form of treatment, you can say you had a part in making history. What you have done will benefit MSers for years to come. You should be proud."

He also told me that Novartis has me scheduled to stay in the study for another year (translates "1 more year or drugs.") and then they will cut me loose with a 3 month supply as a parting gift.

This is totally different from what other people have claimed their trial people have told them. I thought I distinctly remembered crying tears of joy when someone said they knew for a fact we'd be getting 5 years for free.

Anyway, the drug will be a second line drug and will only be prescribed if you have failed 2 other forms of MS drug treatment. Ironically, even though I have been ON this drug for over 3 years now, I would have to prove that I can't take the others before I can be prescribed this.

So I go home floating on a cloud as the reality of how all these years of poking and prodding are resulting in a pill form of MS treatment finally coming to pass. It just makes me burst with pride at all us guinea pigs hanging in there, and I have so much hope in my heart for those of you who cling to every whisper of a hint that something new and better is just right around the corner.... It REALLY IS!

I have said it before and I'll say it again. I was in a terrible spot before this study, and while I knew I was blessed not to be as disabled as other less fortunate MSers, that thought didn't lessen my miserable attitude and feelings of hopelessness. Looking back, I think now that I may have been nearly suicidal. I was just at the end of what I thought I could deal with and knowing it couldn't get any better didn't help. (Rationally, I know now that's not true, but in my own mind, warped by depression, that was how I felt).

This study gave me my life back. I feel better and better all the time, and have not had an MS attack in over 3 years now. Back then, you couldn't have convinced me I'd be sitting here blogging these words 3 years later.

So if you are at your wit's end and praying that something will help you because you just can't take another day of your situation, please hang in there and know that something better truly is within your reach now... just a few more days...

The New Look:
After trading in my empty pill bottles for 3 new sealed bottles, I woke up the next morning after my appointment and groggily grabbed one of them to take my daily pill. I puncture the foil seal on the bottle to set the capsules free and rolled one into my hand. I stare and blink. Not comprehending.

I peer into the bottle to see it was full of about 35 more capsules that looked just like it.

I slap the first pill back inside and cap the bottle, setting it quickly on the table as if it were poison, shoving it away.

I whipped out my cell phone and call the trial nurse, who, much to her chagrin, is on my speed dial.

Trial coordinator: Hello?
Me: I just open my medicine and they've made a mistake!! I got the wrong pills!
Trial coordinator: What? I don't understand. What are you talking about?
Me: The PILLS! They aren't pink or brown, or whatever you want to call that color!
Trial coordinator: They're not??! What do they look like?
Me: (getting out bifocals and trying to really see them) Well, they are gold on one end, white on the other end, and have little gold racing stripes that go around the white end.
Trial coordinator: (silence)
Me: are you there?
Trial coordinator: oh, yes, I am here, but I am confused. Let me call Novartis and I will call you back. Wait 10 minutes and do not take the medicine.
Me: Ok (squinting) but now that I look closer I do see it says "FTY 0.5mg" on the one end of the pill.... maybe this is the new look??
Trial coordinator: That is what I suspect, but let me call to confirm first.

So I wait 10 minutes and my cell phone rings.

Trial coordinator: (excited!) Yes! That is the new look! Tell me again what they look like because now I am curious since I haven't seen them.
Me: (describes them again)
Trial coordinator: I called all the other patients and asked them to open all their bottles and look. You are the only one who got the new pills!

I wonder if it's because Novartis has been watching my blog? (I'm full of myself, aren't I?) but seriously. They have been reading my blog a lot. It's in my stats.

So, if Novartis is following along, isn't all this great publicity you're getting from my blog just wonderful? Say, worth a lifetime of pills? (sigh I had to try).

Anyhow... here they are... TA DA! Sorry the picture isn't so great but we had to use my sister's cell phone since my video camera's "camera only" mode sucks.

Now I'm sorry I didn't hold back on of the pink ones. They're gone forever all but for the picture in the background of this blog.

I guess they needed to make them gold and add racing stripes to justify the price they're going to be gouging us for.

Checkup 22 TRANSFORMS FTY720, Fingolimod, Gilenia Clinical Trial

2010-09-08T10:28:00.000-04:00

On the 20th of August I had reached the big 3 year milestone in this clinical trial and had a nagging thought that the clinical trial director had told me when my anniversary appointment would be, but I didn't worry too much because she ALWAYS calls the week before to make certain I didn't forget (which I always do).

This time was the same as usual -- on my part -- and I completely forgot. It was not the same as usual on her part as she, too, forgot. She called me yesterday as I was about to take my pill somewhere near 9am. She told me she forgot to call and all my tests were scheduled for that day. It's a 2 hour drive to get there and I hadn't showered yet, so we compromised and she rescheduled some stuff. I got her to push the dreaded MRI back 2 weeks and the skin exam will be the same day.

Whew. I CANNOT just be told "you're having an MRI now," without a sufficient period of pre-MRI worry time. I have to psych myself up for it like Rocky Balboa drinking his pitcher full of raw eggs and stuff. Only my pitcher needs to be full of Xanax.

So I get my shower and call my friend Karen to ride up with me. She drops everything and goes. I know I'll need her for the ride back if the 4:30pm eye exam goes anything like last time .

We get there and I go right in. I have my vitals taken, blood drawn, EKG and peg test and fast paced walking. Then I go across the street to the hospital for my PFT. Everywhere I go everyone is abuzz about how the med is nearing approval.

I ace all my tests and come back to the Research Department for my EDSS and the Numbers Guy. That's the one where the recorded guy says a number every 3 seconds and you have to add the first two, say the result, then forget what you said, remember the last number he said, and add it to the new number he said. Sound confusing? Try doing it.

Evil Recording guy: 5 ...... 3
Me: 8
Evil Recording guy: 7
Me: 10
and so on...
I did perfect until halfway through when I became acutely self-conscious with Karen in the room. I was wondering if she was following along and heard me hesitate at the dreaded 9's. I don't know why I get hung up adding 9 to a number but I do and always before I just got a little slower; I didn't go dead in the water with Evil Recording guy spouting off numbers while I drooled.

Yesterday I missed 3. Out of 60 numbers, that's not too bad.

Then I had my EDSS test and I got to skip walking the hall since I had walked across the street to the hospital and back and that was far enough according to the people in charge of testing me. They used a high tech way of measuring my ability. They asked Karen if I could keep up with her. Hey, I'm not complaining. Any time I get out of the "25 Lap Hall Walking Marathon" for MS I'm happy.

Then it was on to the eye exam which I had been stressing over since my incredible headache and starry-eyed vision the last time I got dilated. After a lengthy conversation with the eye doctor, she reassured me that I would be fine and we proceeded with the drops.

After the eye appointment I had to go back to Research and see the head neuro overseeing the trial at this location. He wacked me with his rubber triangle hammer in a few places, told me how I looked better and better every time I saw him and then started talking about the Exciting News!

With that teaser I'll just leave you hanging for a brief time while I tend to my duties long enough to carve out another slot of time in which I can sit and type the juicy details. Stay tuned!

Results of the Bone Density Scan and Aftermath

2010-09-05T19:27:00.000-04:00

Last time I saw the GYN he told me my blood test revealed my ovaries had given up the ghost and were just sorry sacks of freeloading flesh, never to serve another productive day in their pathetic lives. Well, I'm paraphrasing him, but that's basically the gist of it. I have entered menopause.

He gave me a script for Estradiol that is bioidentical (or molecularly identical) to human estrogen. He also had to give me a handout with all the data gleaned from the Women's Health Initiative, a poorly design study in which skewed results were obtained due to many factors, not the least of which being that the median age of their "newly menopausal" subjects happened to be 63!?!

Being the certified hypochondriac that I am, I could not just start popping a pill just because it was prescribed for me without a lot of agonizing over the whole ordeal. I don't suffer from menopausal symptoms to such a degree that my life is disrupted by them. The main issue was going to be with whether or not it was going to help me with bone density.

I have had a LOT of steroids since being diagnosed with MS and I had strong suspicions that my bones were thin. I have other risk factors including being "thin" (that's according to my doc, not my own definition because I think I could stand to lose 10lbs), not eating enough calcium rich foods due to being lactose intolerant, I used to smoke, and I am menopausal.

So I promised myself I would hold off on the estrogen decision until the results of the bone density test came back. That happened this past Tuesday when I went in for my checkup.

The nurse looks through my file when she's preparing to take my vitals and she's the one who broke the news. "You have osteopenia. It's a precursor to osteoporosis. Here's a bunch of pamphlets to read."

Gee. Pretty anticlimactic.

So I'm going to see the doc and he's a real talker. My sister had the appointment slot 1/2 hour previous to mine and they put us in adjacent (not to be confused with adjoining) rooms. The doctor talked and talked. I got so bored waiting for my turn that I decided to go all McGyver and try to hear what was going on by cupping my hands in a circle tightly against the wall and jamming my ear down into my home made water glass and see if I could hear anything. I could.

Not much, mind you. Mostly my sisters responses because a) her voice is louder and b) she was facing the wall.

Having fun with my spy game, I decided to get all scientific about it and stand up, slowly sliding my water-glass-hand-cup along the wall searching for the optimal audio reception, finding that the studs really do hinder the sound quality, and if I went above the counter level I could get even better audio.

Realizing the compromising position I was in, half squatting with my ear plaster to my hand-cup against the wall and between the exam table and the chair they give you so your clothes aren't just thrown on the floor, I decided that I better just chill out and resume a more natural stance in a section of the room the nurse would not be alarmed to find me.

It wasn't like he'd been telling her anything she's have needed to go all HIPPA on me about. They were discussing what foods constituted a balanced diet. Big whoop. But it was something to do and I tend to do stuff that hidden camera people would EAT UP if I think I'm alone.

About the time I got situated back in my chair where I had been told to sit, stay, was about the same time I heard her door open and the doc saying his goodbyes. Then I could hear him and the nurse discussing his next patient (moi) out in the hallway.

"Oh, they're sisters? Really! Cool."

He then came in, not mentioning my sister or any Family Plan Discount Coupon he might have in his wallet, but just shook my hand and got busy reviewing my file.

He talked about osteopenia and how it shouldn't be confused with osteoporosis since that's not what I have. We talked about how I need to take an aggressive proactive stance against it and start making changes that would decrease my odds of ending up with osteoporosis.

He then asked me how the Estradiol was working for me. I told him my plan to hold off starting until I got the results he'd just given me. He said that was a fair decision. (I didn't know I was getting judged on my decision making).

So now that I was presented with the results it was do or die time. We rehashed all the risk factors checking off those which apply to me..

"Used to smoke, don't have high intake of calcium, sedentary lifestyle, you're thin..."

"Woah! What was that? You think I"m thin?? Can I get that in writing on your watermarked letterhead?"

Then we go on to discuss the percentage of body fat that people have and your optimal body fat in order to hover in a safe place farthest from osteoporosis risk (on the low end) and cardiac complications (on the high end). It needs to be between 25 and 30% on the scale.

Then he tells me there are scales which can accurately calculate body fat and body water, and you can purchase them at wal-mart.com among other places. Intrigued I whipped out some scratch paper and a pen and started taking notes.

Simultaneously he whipped out his iPhone and started surfing to find the one I needed to get, were I so inclined. After writing the brand name (Taylor) and that it needed to be digital and say that it measures body fat and body water, I felt my heart skip a beat...

I had a defective iron I had purchased the day before and needed the receipt to take it back for exchange. I was hoping against hope I wasn't scribbling all over the back of it. I flipped it over and for a second I was relieved.

Then I burst out laughing and confessed to the doctor that I was taking notes about the scale on the back of a Dunkin Donuts receipt. He, too, had a good laugh.

So we decided that I would increase my calcium intake to between 1100 and 1500 mg / day (I have a 1200 mg chewable I got from Walgreens that fits the bill), and I would get that scale, (which I ordered from Wal-mart.com from this ad) , and that I would begin taking the Estradiol as opposed to my inevitable choices I would later be presented with should my bones continue thinning...

Things like Boneva, Fosomax, and other super expensive osteo drugs. I decided I'd give the Estradiol (at $17 for a 1 mo. supply or if I join Walgreens Rx plan I can get it for $4/mo for a 3mo supply) a try. May as well try the cheap route since I'm not made of money last I checked.

That brings us up to date and I am on day 3 of being an estroginated subject.

Here's what I have found.

1st day I was a little dizzier than my ususal MS/Fingolimod dizzy.
I have only gone through 2 nights since starting and already I sleep better with less insomnia, less restless light sleep, more sound sleep and less hot flashes.
My hips don't hurt as bad. They were stiff and sore all the time but I just figured it was from sitting so much and getting older.

Other than those things I have noticed no difference. My moods stay the same and I don't feel like I have any side effects.

If this helps my menopausal symptoms I had been ignoring (the sleep issues, hot flashes and hip aches) and helps increase my bone density, then I guess I am willing to risk certain minimally possible adverse events.

After all, I'm becoming a pro at this drug taking, weigh the pros and cons stuff. I've had 3 years practice with Fingolimod. :D

Another Year Gone By

2010-09-01T09:22:00.000-04:00

I know I have really slacked off on the blogging and for those of you eager to hear news about Fingolimod (now Gilenia) I do apologize.

Just know that "no news is good news" is the phrase du jour . My 3 year mark in the clinical trial was on August 20, 2010 - 12 days ago! It still amazes me that I have come so far and feel safe in saying my MS is in remission.

It took me SO LONG to get over the feeling that if I sneezed too hard or crossed my eyes, I'd send myself into a relapse. But before Fingolimod that was exactly the case. It didn't take much at all, even just a little stress, to send me into the land of numbness, burning, tingling and limbs I had to drag.

So I guess I am trying to ignore the fact that the trial is probably winding down, as is sure to happen. They have to wrap this up sometime and with the pending FDA review, I have tried to ignore the fact that I will soon have to figure out how to stay on this medication and maintain my good health.

It's crossed my mind on more than one occasion that maybe all the success I have had isn't TOTALLY attributable to FTY720 alone, but was partly brought about by quitting smoking and caffeine, and trying to make better food choices. This is a comforting idea to ponder because in my little pea brain it suggests that I have a fighting chance of staying in remission even without my drugs.

I think that keeping a positive attitude and having a new outlet for my creative energies has also helped to keep me stable. I just can't get enough of the tie-dyeing that my sister and I have started doing/selling. It's been a joy to have something so satisfyingly artistic to do after years of feeling frustrated that MS had taken my finest motor skills so that I no longer can do really detailed pen and ink drawings.

Tie-dye IS an artform, by gosh! And unlike drawings I may have started and got bored with or frustrated by, none of the tie-dye stuff sits around unfinished. I do them beginning to end with the untying being the most exciting part. It feels like Christmas morning every single time. Love to see the surprising designs of colors and patterns.

It's that exhilaration that keeps us doing it, and the fact that it keeps my mind from stagnating in a MS pondering funk is a great big plus. SELLING something would make me even more ecstatic but I guess that's too much to ask for ROFL.

I have another BIG clinical trial checkup coming soon but oddly I have not heard from my trial nurse in a while. Usually she calls a couple weeks before the appt. to confirm. For the past couple "anniversary" appointments, it's always been a big deal, with every single test performed from PFT to MRI -- all having to be completed within so many days (14 or 30 maybe?) of the anniversary date (8/20).

Counting my pills, I see I have 23 left and I already took today's, so I'm good for a few weeks anyhow.

Until then, I'll keep pretending to be normal and revel in my new found creative outlet. Hopefully I'll have a more MS-y, clinical trial-ish post for you soon.

The Psychological Impact of Multiple Sclerosis

2010-08-13T06:32:00.002-04:00

A friend shared this info with me and I thought I should post it.

From the Cleveland Clinic Online Health Chats:

The Pschological Impact of Multiple Sclerosis
Wednesday, August 18, 2010 - 12 Noon (Eastern Time)

Do you have Multiple Sclerosis and find yourself depressed because of the challenges it presents? You are not alone. Up to half of all people who suffer from Multiple Sclerosis also show signs of being depressed, or having psychological problems, at some point during their illness.

To read the whole announcement, click here.

I know I have had low periods during the course of my illness and I am fortunate enough to have not suffered much if any disability. And they don't mention it in the announcement, but MS itself can be a direct cause of psychological problems, I believe.

I once had a relapse in where I suffered severe panic attacks about 5 times a week. A couple of them were so severe that I actually went to the ER thinking I was having a heart attack. Of course I walked out before I was ever seen or called because they wore off within 30 minutes, but I finally had to be put on a low dose of Xanax to be taken as needed for the 3 months that relapse lasted. After that, the panic attacks just faded away and I haven't had one now in 3 years. (knocking wood)

So I know that even if there is little emotional impact from your condition and that you might be handling it well, you could still fall victim to depression simply from your medication or your MS itself.

Have hope! There is light at the end of the tunnel and NO it's not always a train. Seek help and quit suffering. Things CAN be better. I'm living proof. 3 years ago I was suicidal and saw nothing to look forward to when I was relapsing every 3 months. Then I got in this study and my life was turned around. I look back now and I'm so glad I didn't let that depression swallow me whole and do something stupid.

So go check out the chat. Maybe you or the one you love can find some bit of something to take away from it.

TieDyedHippy.com new shirts preview #1

2010-08-05T12:50:00.000-04:00

I know this seems like it's totally out of left field, but my sister and I started a website selling tie dyed stuff called "www.tiedyedhippy.com" and here's a video preview of some stuff that will be listed tomorrow.

It's all one of a kind, unique designs that we probably won't remember how we did it so you are safe in knowing there will never be another just like yours.

I'm hippy #1 in the video and my sister is hippy #2 who can't hold a camera and laugh at the same time.

She came over today (that's the back porch of my mom's house where I am living now) and we showed each other our new stuff and decided to run out back and shoot a video. Getting each product photo shot and prepared for the website takes time and we are like a couple of kids who can't wait for that stuff, so the Video Preview is something we will be doing regularly to show off what's coming soon.

I'll be making a blog for www.TieDyedHippy.com shortly and when I do I will put a link here for those who'd like to follow along. That way I can keep my fingo drug habit blog separate from my hippy tie dyeing adventures. :) I did just want to share with you guys first tho.

So I'm just getting old??

2010-07-18T12:41:00.002-04:00

For the past 3 weeks I have been poked, prodded, scrutinized, observed, jabbed, grabbed and lit up like a Christmas tree. And now I find out that all my problems could quite possibly be caused by my ovaries ceasing to function. Otherwise known as menopause.

Huh. I'd have never have guessed that.

I had a hysterectomy 11 years ago so that's why I had no *clue* if you know what I mean.

After the CT and pelvic ultrasound and all the blood work turned up nothing unusual, I returned to see my GYN and it's his opinion that the discomfort and quite possibly the buzzing could be caused by my lack of estrogen. He knows for certain that my ovaries have stopped working by the results of the blood work.

Everything else that all these doctors have tested for have turned up normal.

The first thing I did was to go home and cancel my colonoscopy. After meeting with the doctor who was supposed to have performed it and getting his opinion that, after viewing the results of my pelvic CT, he didn't expect to find anything unusual on the colonoscopy, I just decided to give myself a break.

They told me I can call to reschedule at any time and I promised myself I would, but I'm just sick of all the cold metal tables and the backless gowns. If I'm never going to again wear a backless gown that's covered with sequins an has matching shoes, than I'm not going to wear one that's one size fits all and still shows my butt. At least not right away.

If the buzzing were getting worse or there was more pain, then maybe, but right now I just want to relax and start taking the Estradial and see if it helps.

The GYN had a long talk with me about the Women's Health Initiative study clinical trial results about hormone replacement therapy and the big scare it gave all women in 2002 when the news had it plastered all over the place that HRT causes breast cancer and increases your chance of heart attack.

We discussed how the study which was supposed to measure the benefits of HRT in NEWLY menopausal women was fundamentally flawed because they selected women who were of the average age of 63 -- an age quite well past "newly" menopausal.

He gave me some literature and told me to go home and research it on the internet. Apparently he hasn't gotten the memo. All my other doctors have each, at one time or another, rolled their eyes, expelled heavy sighs, and told me to "PLEASE, stay OFF the internet, would you?!"

I've been doing very well this time around though. I think I really have learned some lessons about late night frantic, fear-driven searches for answers to the worst possible hypothetical questions. I just am burnt out on that kind of stress and didn't even bother this time.

That said, ovarian cancer had been rolling around my mind the past couple of weeks but I was good, and didn't Google the symptoms.

Because I already know that ovarian cancer, unless it's in late stages, doesn't really have any symptoms (or so I vaguely think I remember from reading about Gilda Radner a long time ago). So the buzz and the pressure/soreness symptoms didn't scare me into thinking it would be a close match.

So, here, on the eve of my 11 year old's 12th birthday, only 3 months shy of the 12th anniversary of my hysterectomy surgery, I sit contemplating on how age is catching up to me no matter how young my mind still insists on acting.

Who'd have thought a little estrogen might fix all my complaints? Doc asked if I'd been having hot flashes (check), night sweats (check), mood swings (check), achy joints (check), trouble sleeping (check)...

I think I'm going to start the Estradial. It can't hurt to try it for a couple months and see if it helps. I may feel a lot better or maybe nothing will change. For $4 a month (full Rx price with no insurance) I can find out.

If only Fingo were going to be that cheap...

An interesting survey

2010-07-14T10:43:00.005-04:00

I know a lot of my readers are MSers and quite a few of you may also be members of www.patientslikeme.com. If so, did you get the invitation to participate in a survey recently?

It was a survey titled "If you could choose the packaging for a pill for MS, would it look like this?" Normally I am hit or miss on the surveys I take. It depends on my mood. Sometimes I have even been know to delete emails from places like that without even reading them if I haven't weeded my email account garden lately and I'm going nuts trying to spruce it back into shape. I might have 100 unread emails and if they look spamy in the least, they're history.

Why I chose to open this email and respond before I even saw the title, I can only attribute to serendipity.

As I suspected, once I started the survey it was instantly clear to me that the medication in question was Gilenia, Fingolimod, FTY720, that Chinese fungus, whatever you want to call it.

There were 3 videos included showing 3 prospective packaging ideas.

The first one appears to be some contraption that is made of plastic, has windows where you can view your medication packets that are blister packed inside. You slide the guts out, push your pill through the blister pack, slide the guts back in, and tilt the whole contraption so that the pill "dispenses" into your hand.

The days of the week are clearly marked beside each pill so you can easily see which pill you need to take next and if you already took the one for today or not. Kind of like it comes in it's own pill minder box or something.

Now, I had copied all the questions and my essay type answers to a notepad file but got distracted by something before saving it. Then I forgot about it and went to bed. This morning I wake up to find my computer had rebooted after installing updates (I thought I had changed that setting! Doh!) and so I lost all my witty answers and their respective questions.

I did save a file that had the urls of all their youtube videos that they used in the survey. I am not sure what the ramifications would be if I shared them here as they were not shared on youtube.com. Erring on the side of caution, I'll just describe their use as I witnessed in the video.

The next prospective package looks like samples you might get at a doctor's office. The package initially looks like a little cardboard "book" and you open it up to reveal your pills -- all marked with the days of the week -- embedded in the book in a blister pack. You open it all up, find the correct day, push the pill through the blister and it falls into your hand underneath. You fold the book back up and slide the whole thing into another cardboard sleeve much like VCR tapes used to come in.

This one looks like a huge waste of paper to me.

The last one looks like any other capsule type medication you might buy like say Benadryl. Open the box, slide out the cardboard card with blisters on it, push the pill through the aluminum foil backing. Still, in my opinion, too much packaging.

What I told them in the area they gave me for comments on the survey is that I have been in this study for 3 years now and have only missed a grand total of 3 pills due to not planning ahead and being in the wrong place at pill time (all 3 times I was 30 min or more away from my pills).

I do not need a pharmaceutical company to tell me what day it is or when to take my pill. I can get a pill minder for that for just a couple bucks at CVS or Walgreens. No doubt it will cost much less that way than having my pills already come in some kind of pill minder.

I also told them I had taken Copaxone for 8 years prior to getting into the study and that stuff doesn't come all labeled with the days of the week.

I guess they mean well, but it's my impression that they are going to go with some type of outrageous packaging in order to justify the cost of what they're planning on gouging us for. If they are really concerned about the compromised dexterity of some MSers then perhaps the final choice with just the simple foil back blister pack might be the way to go. But really, anyone with problems getting their pills out of a bottle already has devised a way to do this for all their other medications, haven't they? Why special (read: costly) packaging for Gilenia?

They wanted to know my impression on how child-proof the packaging was at the same time, how easy it was to dispense for the intended patient.

What I want to know is WHY are they trying to reinvent the wheel, or in this case, the bottle?? See that bottle at the top left of this screen? That's what my medicine has always come in since starting this trial. They are not worried about impressing me with its looks at this point, so I imagine I'm actually receiving the pills in the most cost effect container at this time. It has a childproof cap.

Voila! Stick your label on it and call it a day.

I think most of us who have to take other things on a daily basis such as our multivitamin or prescription drugs will be able to figure out how to remember to take our pill every day. Please leave the cost of the hand holding out of the equation.

What we really need, that you didn't bother to ask, is to give input on how much we can afford to pay for this new medicine. Why didn't you ask about that, Novartis?

Keep your fancy Pez dispenser and just give me some pills I can afford. Thanks.

Nothing to report yet...

2010-07-14T10:15:00.002-04:00

I've just been poked and prodded more and more.

I went to the consultation with the GI guy who's going to do the colonoscopy and he seemed confident after a preliminary exam that my test was going to reveal nothing profound.

Then I went on Monday and had an abdominal ultrasound. She spent quite a bit of time trying to isolate my right ovary for imaging and it was pretty uncomfortable. Of course she kept that poker face that all techs have to have and I didn't even bother asking if she saw anything. I knew the answer would be "I'm not allowed to say".

In any event, getting my digestive system "regular" again seems to have helped with the symptoms although I still get that fluttering nerve tingling "wack-your-funny-bone" feeling in my lower right abdomen so who knows. By the time they figure it out I'll either be back to normal or really ill.

I have let it go though. I'm no longer stressing over it. I just can't drain myself with worry that way. I think when you do that it only complicates things and increases any pain you might already be enduring.

When I get stressed my stomach knots up. My stomach already is uncomfortable so screw stress.

Now, when I find myself dwelling on all of this in an unhealthy way, I focus on my son and we do something fun together. Hey, if I can't fix what's wrong then doing something fun to pass the time is better than sitting in the dark and worrying. Either way the time is going to pass. May as well have a memory to show for it.

So I've been going to the beach a lot. I had forgotten how calming and soothing the sound of the gentle surf can be. And the cawing of the seagulls as they circle overhead. The sun is not exactly my friend, but we go early enough that it's still relatively cool out and the ocean is warm as bath water. We live on the side of Florida that is almost as far from the Gulf oil spill as you can get -- the NE coast. Even though it was reported that tar balls were found on the beach the other day (and ruled out as far as being from the BP spill) we found the beaches to be pristine sugar sand that felt luxurious on our feet.

Any stress I might have felt before just melts away with the sun, the surf and the gentle breeze in my hair.

And it's nice to see my son with a smile on his face, and no electronics were used in the creation of his happiness.

I'm thinking I get more from the beach than I've been getting from the doctors. At least I come away with less stress than more. :)

Is there no help for me? LOL

2010-07-08T17:41:00.003-04:00

I just read my last post and realized I was whining and complaining about being a whiner and complainer.

Ok, it's safe to some back because I'm not going to apologize any more. Take me as I am. I can't be any other way.

Love you all for hanging in there with me. Now back to my eccentric, hopefully humorous, reality.

Blogs come in all levels of hilarity, self-absorption, information, etc. I can't write like anyone but me, so I'm not going to try pretending.

Thanks for playing along. We now return you to the previously scheduled "As Jeri's World Turns".... we left off with her worrying about some undefined stomach pain and nerve twitching.

Will the doctors find out what's causing this?

Will she need surgery or just a good dose or two of Mirilax?

Stay tuned....

Today's Results

2010-07-08T16:56:00.003-04:00

Since I had gone to my PCP and he had ordered the CTs of my pelvis and abdomen and then, the next day, referred me to my GYN, it stood to reason that something the PCP saw on the CT needed the attention of the GYN. (are you following this?)

Turns out there was nothing notable on the CT. Nothing abnormal about any organs and no sign of aortic aneurysm or anything else. No masses, nada, zip, zilch.

GYN did a full exam and then ordered a pelvic ultrasound which I will have on Monday.

Tomorrow I go to the consultation visit for the colonoscopy. One test I'm really not looking forward to, but as long as they are poking and prodding every inch of me, what the hey.

It may end up being MS after all...who knows. I do know I need to let go of the worry and of things beyond my control.

I really don't know how those of you out there who have severe disability can cope so well. How do you find the joy in living each day for all it's worth? You are my inspiration, I want you to know. I admire each and every one of you who finds the inner strength to face each day with a smile on your face and not dwell on the bad, but focus on the good.

I thought I was doing so well and had such a good attitude until learning that others see me as a complainer. I am ashamed of myself for being so blessed with the good health I have --compared to so many of you who have lost so much -- and I have been bothered by this all day. I will try to take into consideration that much of my audience consists of MSers who undoubtedly have more issues than I, and I will try not to appear so self-absorbed and whiny.

I do have it good. I am so blessed that my MS is so mild after 11 years. I do thank God every day that I can still walk, that I'm in this trial, that things seem to be going well for me.

I really am not trying to focus on something little and make a mountain out of a mole hill. I have just lost too many people in my life to stuff they brushed off as nothing, which came back to bite them and turned out to be something. I'm not going to let something this weird and abnormal just slide by with no explanation.

I've been writing this blog ever since the start of my trial and I promised myself I wouldn't just be a fair weather blogger, logging only the good things. Rather this is documentation (however interspersed with trivial, unrelated flotsam and jetsam) and all these tests are part of that process.

If this turns out to be in some way related to the clinical trial, I think those who follow along, wanting the unvarnished truth about a first hand participant's experience, deserve to be given the honest truth. Of course I can't hide the fear or whininess, but I'll try.

Hopefully I can get back to posting the hilarity of it all -- just as soon as I get my sense of humor back. I know it's around here somewhere...

My Apologies

2010-07-08T05:34:00.002-04:00

To all those suffering from MS who have it so much worse than I do.

As you can see from Kim's comment on my last post, I apparently complain a lot. For that I am truly sorry. I know there are many who suffer far worse than I, and I DO thank my lucky stars that Fingolimod has brought my EDSS from where I was using canes and occasionally a wheelchair and had gone from relapsing every 3 months to not having a relapse in 3 YEARS.

I didn't realize I was such a complainer. I have, right in the tagline of my blog, admitted to being a hypochondriac and I'm a 9.9 on the Worrier Scale, but I didn't realize "Complainer" was my other hat I wear.

I don't do it trying to disrespect anyone else who suffers far worse than I.

And if you mean because I posted about the "buzz" I was feeling in my groin, and you think that it's a slight MS symptom that is unworthy of my worry, mention or complaint, then I have GREAT NEWS for you! IT'S NOT an MS symptom.

I had the CT on Tuesday and yesterday, while trying to shake off the worry and hang out with a friend to watch Avatar, I get a call on my cell phone from my GYN's office. Haven't spoken to them in about a year....

Apparently my PCP called them to refer me due to whatever was seen on the CT.

I won't know what's going on until after 8:45 when I go see him.

When I hung up the phone I immediately puked.

So again, I do apologize to anyone with MS worse than what I have. I am sorry that I appear ungrateful for the mild case of the disease that I have been blessed to endure. And I'm sorry that I whine about whether or not I'll be able to afford this drug which has given me back my life.

As it turns out, I may not have to worry. They may just pull me out of the trial.

Sorry to sound crabby. I don't mean to lash out. I would hate to be in ICU/CCU for MS symptoms of have ports installed for delivery of medicine, or have my child not remember that I could ever walk...

I started this blog to give hope, relieve angst, abate fear, and to let the world know that if I, The Worry Queen, can do it (the trial), anyone can. I hope in some small way I have contributed something others with MS felt was worthy of their time spent reading it. If not, my apologies.

Just because the things I fear are not as bad as what others might live, doesn't mean I'm not going to worry. Maybe I'll just do it inside my own head from now on so you don't read it as complaining....

What's the buzz all about?

2010-07-02T12:52:00.004-04:00

No, not some new designer MS drug that I'm going to be talking about... but a BUZZ, literally, in my lower right abdomen.

The only way to explain this odd sensation is to equate it to wacking your funny bone (not so funny, eh?) really hard and that tingling, buzzing sensation that you get. That's what I keep feeling in my right groin and lower right abdomen area. It briefly shoots that buzz down my right leg and up across my side. Sometimes even causing loss of control of that leg briefly. I can't tell you how many times I have nearly fallen because of it.

I had a clinical trial checkup a couple weeks ago and told them about this sensation. The clinical trial nurse said she'd speak with the head neuro and see what we should do about it. Meanwhile I had an EDSS test performed (Expanded Disability Status Scale test) and there was no change, therefore they think it's not MS.

It's been getting worse over the past 2 months. I hadn't really thought about it much because up until I saw the study people I assumed it was maybe a new MS flare and I'd just let them know. After all, I have had Lhermitte's Sign before and that's what this feels like. However I did find it odd that the sensation was down the FRONT of my leg and not the back.

They told me I needed to go see my primary care physician. I saw him Wednesday and ever since I have been a nervous wreck. I can't eat, I can't sleep, and I daydream constantly about what it might feel like to die.

What did he say, you are wondering all alarmed? He doesn't know. There's not enough symptoms to make a diagnosis without a bunch of tests. So....

I have to have a CT of my abdomen and another of my pelvis, I have to have a bunch of blood work done, and I have to have a repeat colonoscopy because the last one I had was 10 years ago.

When I asked what it could possibly be, he said it could be any number of things ranging from ovarian cancer to a colon cancer, to trouble with gall bladder, appendix or a kidney stone. Until we have all the tests back, there's just no telling.

That night I couldn't sleep. I lay there in my bed, staring at the ceiling wondering if the answer is going to be a death sentence.

Another of the symptoms I noticed and mentioned to the doctor was that the nerve trouble seems worse with constipation and since I am pretty regularly constipated (hey! I just made up an oxymoron!) he's got me on Mirilax to try and clear that up.

My CTs were scheduled for 10am today and I called at 8 and rescheduled. I don't know if it's because I am frozen from fear (most likely) or that my rationale made sense, but I told them I wanted to give the constipation a chance to clear up so they could see everything clearly on the CTs.

Now I've bought myself time until Tuesday at 10:30.

The colonoscopy scares me even more. I hate feeling so helpless and vulnerable while being poked and prodded. I'd just as soon go on day in and day out having a normal healthy life, thank you very much. But that is not to be. Chronic illness sucks but something like this scares me even more... and until I know what I am facing I guess this fear will just keep me paralyzed.

See, it's my philosophy that as long as I don't know it's something terrible, I can pretend it's not. But the minute they sit me down to deliver news of something awful, I'm going to snap and just go into one irreversible panic attack. I just can't deal with it. Fear is awful.

And it's not getting any better. I keep telling myself it's just a pinched nerve, but there's a strange "fullness" on that side of my abdomen that makes sitting or bending uncomfortable. Not painful, just feels like when you are really constipated, only I have not had that issue in several days.

Ideally I would like to find out that it's a benign cyst that they can empty with a needle and I don't have to have surgery, chemo, radiation or anything else.

I'm just so freaking scared though...thinking about everyone I have lost to cancer in my life and how it seemed quite painful in the end.

I'll know more next week, so I'll be certain to post the good, the bad and the ugly.

Stay tuned. (What a cliff hanger, eh?)

OMG IT's TRUE!! The advisory board recommended approval of FTY720!

2010-06-11T17:35:00.003-04:00

http://www.prnewswire.com/news-releases/fda-advisory-committee-unanimously-recommends-approval-of-novartis-investigational-treatment-fty720-to-treat-relapsing-remitting-ms-96104399.html

I just got this as a comment -- THANKS KIM and LF!

Oh, and I forgot...

2010-05-27T21:58:00.002-04:00

One of the other symptoms I've been having is short term memory loss.

I have always been kind of an airhead that spaces stuff out, but I have been COMPLETELY and thoroughly forgetting entire conversations and other important stuff lately.

I have to write copious notes and then REMEMBER to read them.

I'll have to mention that at my appointment....

...I hope I don't forget.

News on Gilenia, Fingolimod, FTY720

2010-05-27T18:37:00.004-04:00

I'm slacking again, I know, I know.

There's news out and I haven't yet reported it...
http://www.novartis.com/newsroom/media-releases/en/2010/1418321.shtml

FDA has extended the review period by another 3 months pushing the expected approval date from June 21 to Sept.

I know this is disappointing to some and I feel bad for those who are eager to give Fingo a try, but for me it's another 3 months of free meds for certain.

I really don't know what I'll do if they take this stuff away.

That said, I do suspect that I am currently in a relapse. I'll know for certain in a week or two when I go to my next checkup. I say that I suspect it due to having reduced sensation in the bottoms of both feet, kind of like wearing socks when I'm really barefoot. I also have this odd Lehrmitte's type of buzzing, shocking sensation that runs from my groin down the front of my thigh and for an instant I lose all control of that leg. I don't know if it's truly Lehrmitte's though as I don't feel it's caused by a lesion in my cervical spine. The position or movement of my head seems not to affect it at all.

It's not a constant pain but a fleeting symptom that comes without warning and has caused me to fall several times, usually at inopportune moments (but when is it ever okay to fall just because you had nothing else planned at that moment?).

Beyond that, spasticity has returned to haunt my daily movements. My legs seem stiff and pained just about constantly although I can make myself ignore it.

I think that Fingo has kept the symptoms of this relapse -- if indeed that's what this is -- to such a minimum that it has allowed me to convince myself that I'm just having a bad day today" and not really relapsing. But it just dawned on me the other day that I have been having these bad days for a few weeks straight.

It's not the knock down, drag out, kind of relapse that punches you in the gut and lets you know it means business. I'm not trying to find what I did with my cane. I just feel "off". If that's a relapse, then I can live with it.

Better than the old ones that caused me to reflect on whether life really was worth living. Many was the time I suspected not.

So, I leave you today with this thought... If a relapse falls in the forest and nobody's paying attention to it, did it really happen?

I guess only my MRI tech knows for sure.

I hope they don't make me get in that thing...

OH, HAPPY DAY AFTER WORLD MS DAY! (always fashionably late to the party. sigh.)

For the Love of Oreganato Bread

2010-05-08T09:42:00.002-04:00

My father, who passed away in 2000, was an avid baker. It was his hobby, his passion, to cook and bake exquisite concoctions to please his family and friends. His specialty was bread.

He once had to spend more than a month in a Skilled Nursing Unit at the hospital after having a hip replacement. They had an activities director who did things with the patients to keep their spirits up and to get them socializing. One day she brought a bread machine in and made fresh bread for everyone.

Dad saw what a profound effect a simple thing like fresh baked bread could have on the spirits of the patients that he vowed to bake for them every week when he got out. Of course, he did it the old fashioned way, not with a lowly bread machine. "You can't get the love worked into the loaf if you're not kneading it by hand", he would say.

That was 10 years before he passed away, and for 10 years everyone looked forward to his weekly, sometimes twice weekly, visits bearing gifts of bread, still warm from the oven.

Faculty would flock from all over the hospital for a crumb of his loaves. And the patients would break out in smiles at the site of him coming in the door with his big brown grocery bags.

He never asked for a thing in return. He paid for it all out of his own pocket. His reward was the satisfaction in seeing so many people smile.

They loved him.

After he died, I visited the SNU and brought a gift of my own brown bag full of loaves made from his recipes. The staff embraced me and cried with me as they let me know how much my father had brightened their lives and touched their hearts with his simple homemade gift.

I wanted so badly to carry on the tradition but it hurt too much to try. So I only bake bread for family on special occasions.

I now live in his home and every day I use the counters, stove, oven and sink where all those loaves were made. I think about it often.
I found his bread book the other day and, although he's been gone for 10 years now, I cried when I saw all his handwritten notes.

This Oreganato was my mother's favorite of all his bread recipes, so I surprised her the other night when I baked two loaves for her.

She had mentioned in passing that she had to start eating store bought bagels after Dad died because she didn't have any homemade bread any more. I'm not making any promises out loud, but I think it's time I brought a little of Dad back to the kitchen and kept the bread making tradition going.

Oreganato Bread

Makes 2 1.5lb loaves

A brightly spiced and herbed French-style bread (it contains no oil, milk or sweeteners), especially good when served with seafood or pasta dishes, Oreganato is seasoned with cracked black peppercorns, garlic, parsley and oregano and it sparkles with a golden glint of polenta nuggets. It's important to use polenta which is course, rather than cornmeal which is fine, because polenta retains its identity in the loaf.

8 cups high-gluten bread flour or unbleached all-purpose flour
3/4 C uncooked polenta
4 tsp. granulated garlic or 4 Tbsp. crushed fresh garlic
6 tsp. dried parsley flakes or 6 Tbsp chopped fresh parsley
4 tsp. dried oregano or 4 Tbsp fresh, chopped oregano
2 tsp. coarsely cracked black pepper (this can be omitted or you can use reg. black pepper if you don't like it quite so hot)
2 Tbsp instant yeast or 2.5 tablespoons active dry yeast (proof active dry yeast first in 4Tbsp lukewarm water)
2 Tbsp sea salt
Approximately 2 3/4 - 3 cups water

Mixing and Kneading
Mix all of the dry ingredients including the yeast together in a bowl, then add the water, saving some for the final adjustments. Turn the mixture out onto a floured counter and knead for 10-15 min. or untilo the dough is elastic yet firm, tacky but not sticky. Enjoy the garlic and herb bouquet while you knead.

Proofing and Forming Loaves
Return the dough to a clean bowl, cover it with a damp towel or plastic wrap or slip the bowl into a plastic bag.
Allow it to rise for 1.5 hrs. at room temperature for the first rise.
Punch down and knead gently for 5 minutes.
If you are making pan loaves, form them into loaves and allow the loaves to rise in the pans for an additional hour.
If you are making free-standing French loaves, allow the dough to rise in the bowl once more for an hour, then follow the instructions below for forming loaves.

Forming French Loaves
Cut the dough into 4 pieces to make baguettes.
Roll out each piece of dough into a long rectangle.
Fold it into thirds, from top to bottom, and roll it out again, keeping the seam on the bottom.
Fold the rectangle of dough in thirds again, crimping the seam with your fingers so that it will not open up.
The goal is to create a firm surface tension that allows the bread to rise rather than spread out sideways. If the dough becomes too tough to roll out, allow it to rest, covered, for about 3-5 min. This lets the gluten relax and then the dough should be more compliant. If it begins to dry out, spray it with water.

Sprinkle a baking pan or French bread molds (curved metal cylinders) with polenta to prevent the dough from sticking and to give a nice crackle to the bottom of the loaf. Do not oil the pan as this will brown the bottom of the loaf prematurely.
Place the baguette seam side down on the pan.

Some days you can't escape the things that bother you

2010-04-13T13:02:00.002-04:00

As illustrated by this dog, tormented by his own shadow (there's a couple F-bombs in the audio, so watch out for young ears).

It's like trying to escape or confront the *shadow* of MS... only way more funny.

Gilenia(R)* (FTY720) shown to reduce relapse rates regardless of treatment history

2010-04-13T09:15:00.002-04:00

Read the whole press release

An excerpt of the part about the TRANSFORMS trial:

Of the 1153 patients who participated in the one-year TRANSFORMS study, 1027 (89%) elected to enter the one-year extension study. Patients in the extension study who also received Gilenia in the core study remained on their original dose (0.5 mg or 1.25 mg), while patients who had received intramuscular interferon beta-1a (Avonex^®) were randomized to receive Gilenia 0.5 mg or 1.25 mg[2].

Patients who received Gilenia 0.5 mg for two years experienced a consistently low ARR at year one (0.16) and at year two (0.18). These patients also retained a significant reduction in relapses and MRI brain lesions over two years compared to the group originally randomized to intramuscular interferon beta-1a and later switched to Gilenia[2].

In the subset of patients who received intramuscular interferon beta-1a during year one and Gilenia 0.5 mg during year two, the annual relapse rate in year two was reduced by 31% and the number of new or newly enlarged T2 lesions in the brain, a marker of disease activity, was reduced by 67% in the second year[2].

These findings on efficacy are consistent with those of the one-year core TRANSFORMS study demonstrating Gilenia significantly reduced annualized relapse rates by 52% (0.5 mg dose) vs. intramuscular interferon beta-1a[3].

This is such awesome news! I was just explaining to my son this morning how close I was to suicide before this opportunity came along. I wanted him to know that no matter how bad things may seem in life, the situations we find ourselves in are fleeting, but death is permanent. If I had chosen suicide, I would have deprived myself -- an my family -- of these wonderful last three years that I had no idea would be such a vast improvement for me health wise.

You just never know where your rainbow is going to come from...Gilenia (Fingolimod) is mine. :-)

A gentle nudge, hint, suggestion for Novartis

2010-04-08T09:46:00.002-04:00

What the heck. I've already posted twice this morning, why not make it a hat trick, right? That should settle the natives who have restlessly been awaiting some new smoke signals from my blog.

Anyhoo, I was hanging out on Facebook yesterday trying to wrap my 49 year old brain around the site that was obviously created for the under 30 crowd (and being unsuccessful at figuring anything out, I might add) when I got a message from a friend. She's also an MSer and in the Fingolimod, FTY720, a.k.a. Gilenia trial and she knows how concerned I am about my medicinal future and whether or not I will be begging for someone to help me pay for the stuff month by month after the party (clinical trials are FUN!) is over.

I asked if I could quote her and she said I could. Here's what she had to say:

"I just had my 18 month check up yesterday, and was told by one of the trial coordinators that the head of the study from our location was/is working on our behalf.

At a conference recently, the neuro was advocating to Novartis that they should do something to take care of us guinea pigs when the drug is approved to the FDA and released to the market. He didn't think it is right if we have put in the time, just to possibly be cut off of our wonder drug."

So, to Novartis, if you are listening, PLEASE PLEASE (picture me on my knees here) have mercy on those of us who have laid our bodies on your examining tables and offered ourselves up for your poking and prodding, needle sticking and eye exams and PFTs and MRIs and CTs and all the other abc tests...

We have come to you as a last resort, some of us. We have no health insurance and the only way we could get treatment for our disease and ease some of the suffering and slow the progression was to gamble with our very lives and let you use us as guinea pigs in order to advance treatment for all who suffer from MS. We have had to deal with the news that at least 2 fellow lab rats gave their very lives to this clinical trial. For a hypochondriac to continue and forge ahead despite this news was the hardest thing I have ever had to do.

Novartis, your company has a reputation for compassion, and I plead with you to show that compassion when this trial is over. Give those of us who cannot afford to buy this miracle drug (of which I am the #1 cheerleader) a chance to stay on the medicine and continue leading lives that are once again worth living.

I am terrified that you will snatch it away and I will be left to once again have my MS run rampant and destroy my body. Please, please don't take it away.

From all of us who have helped you make Gilenia a success, we're just asking for a little compassion. Not too much to ask, is it?

Inspirations from Michael J. Fox

2010-04-08T09:16:00.002-04:00

I try to have a positive point of view and do the glass half full thing, but nobody can be upbeat and happy ALL the time. If they are, you just want to grab them by the throat and shake them until they feel as lousy as you, thus brightening your own day.

Anyhow, not to say I've been down or anything... just a little stressed out. My entire family had the flu that dragged on for 2 weeks, followed immediately by my youngest going back to school for a day or two just long enough to catch Strep Throat. He topped it off with Scarlet Fever. So for nearly 3 weeks I have been taking care of someone who was ill, including myself for a 3 day stretch over our first nice weekend of the season. All I could do was lay around aching and feverish while looking at what a beautiful sunny day it was through the window.

So I have been feeling stressed and worn out lately. Wondering if that's what's bringing on the gut craps (stress) and just not feeling very cheerful or finding any fun in my life lately. Then last night I sat down and grabbed the latest Reader's Digest with Michael J. Fox's smiling face on the cover. I flipped through to find his story.

As everyone knows by now, unless you have been buried in a time capsule and are still shaking off the dirt, Michael J. Fox has been diagnosed with young onset Parkinson's Disease. He's had it rough, to say the least. And being one who has another chronic, debilitating, incurable disease of the nervous system, I have always feel a camaraderie with him and looked up to him for how he soldiered on through life with a smile on his face.

The magazine included an excerpt from his new book titled "A Funny Thing Happened On The Way To The Future". In the excerpt I found a very poignant point he made that was so very zen-like that it made me stop and think. It reads...

"So let me make this suggestion. Don't spend a lot of time imagining the worse-case scenario. It rarely goes down as you imagine it will, and if by some fluke it does, you will have lived it twice."

and a quote from the interview itself...

"...if I stand apart from the moment and say 'In this moment, I am struggling and I can't do what I want to do,' not only have I not had a good moment, I've missed the moment completely, just by standing outside it and judging it."

That man would make an incredible friend. He is so positive and he "gets" it. He knows what to appreciate and why you should.

So many able bodied people go through life complaining about this or that, never realizing the gift they have of just being healthy. I know. I was one of those people. I remember lamenting my boring life.

Now, with the help of my medication, I lavish in boring where the drama of MS is gone from my mind.

I thought it worth blogging both of those quotes as everyone needs some positive perspective. In my eyes, Michael J. Fox is a heckuva role model. Thanks, Michael, for spreading your positive message like sunshine. :D

Elevated Liver Enzymes and Gut Wrenching Charlie Horses

2010-04-08T08:44:00.003-04:00

I had the blood draw a week ago today and the phone call with the results came on Monday. At least they hadn't gone UP, but they didn't go down. They were "about the same".

My clinical trial nurse says the neuro is on vacation until next week so she's going to get with me then, after he's had a chance to review the data, and let me know what the course of action will be. Naturally, I wanted to know if I'd have to get off the Gilenia (a.k.a. FTY720, a.k.a. Fingolimod). She said the numbers weren't so high as to warrant that, but we may have to keep tabs on it more often than the every-3-months check-ups we'd been doing.

From a hypochondriac's point of view, I would really like to know what a liver that is excreting high levels of enzymes is supposed to feel like. First, I need to google where my liver IS so I can being imagining pains in the appropriate spot.

I kid you not, though, I have been having trouble for the last few days with a spot in my upper right abdomen, just beneath my ribcage. I've had this pain before and everyone thought I was nuts when I described it. It feels EXACTLY like a charlie horse in my guts. On a scale of 1-10, the pain, when it hits, is oh.... somewhere around 100. "Owie! Owie! Owie!" is all I can say as I writhe around trying to get in a position that will make the agony stop. It's worse than labor pains, that's no lie.

It only lasts for a few minutes, but I am always alarmed and sure I am dying.

Last time I had the charlie horse was Christmas day. I had to get out of the kitchen and go lay down and roll around biting my lip trying not to scream.

I contributed it to wearing pants that were too tight which created the dreaded Muffin Top Effect, and then trying to bend over. Certainly one's guts cannot survive that kind of punishment without some objection. I have never in my life (before now) been overweight to any degree, so since I gained 20lbs after quitting smoking, I have had to learn all about the discomforts of carrying around 2 10lb sacks of potatoes I can't set down.

Before gaining the weight I had never had this weird gut cramp, so I am motivated to lose the extra baggage in hopes of never experiencing it again.

Besides the weight issue, I thought perhaps it could have something to do with the nerves controlling my guts. Kind of like spasticity of the intestines or something. Once you've had MS for a decade plus, you catch yourself blaming it for everything from an eye twitch to not being able to find your keys.

Then, in casual conversation the other day, I mention the gut cramp to a friend of mine. Turns out she (who does NOT have MS... or maybe she does? hmmm) has the same charlie horse thing happen to her! We started to compare notes.

We are both lactose intolerant but she has actually brought up the phenomenon with her doctor and was told it is related to the IBS she has also been diagnosed with. I have never had an actual diagnosis of IBS but naturally I googled it and now display all the classic symptoms. I guess maybe I have it. Who knows? But I'm going to keep wearing my comfy sweat pants and let it all hang out until I can get in to see a doctor to find out what's going on.

Elevated Liver Enzymes...

2010-03-26T19:55:00.004-04:00

... were known to be a risk as far back as before I signed the original consent form.

Here's a screen shot of the scan I made of the original form:

The study nurse did tell me a while back that one person had to be taken off the meds due to elevated liver enzymes, but was subsequently restarted when they returned to within normal limits.

I'm just hoping I'm back to normal at the next blood draw.

{crossing fingers}

Down for the count

2010-03-26T17:22:00.003-04:00

Two Sundays ago I was at my elder son's house and found that his roommate was coming down with a nasty case of "something". My son and his wife soon followed in her footsteps with everyone in the household --save my 7 year old granddaughter -- rolling around moaning about how terrible they felt in between trips to the bathroom for a chorus of dry heaves.

I decided to keep my granddaughter for a day or two to let everyone have time to revile in their own misery. And the first night we had her, she spiked a fever of 104. So much for saving her from the terrible case of "something."

That was last Tuesday. For the next 4 days I was playing nursemaid/quarantine guard to my granddaughter who so quietly laid in bed, never complaining, and barely moving about. I was trying hard not to catch whatever IT was and washed my hands until they were raw and cracked.

I ended up taking her to the doctor who looked down her throat with a black light/hand gun looking thing and pronounced "She's got strep!"

I'm not convinced of the accuracy of a tool left over from some hippy pot-smoking sixties era novelty shop, so I'm still skeptical that she had strep. We got antibiotics and after another 4 days she seemed better. She probably would have felt better by then anyhow.

So two days before she returned home, I awoke in the middle of the night to much stronger feelings of achiness than I felt should be normal for my nearly 50 body. By midday that day I was spiking my own fever.

I took Advil and laid in bed for an entire weekend while my elderly mother took over caring for my granddaughter. At least I felt she was probably past the contagious stage.

After my 3 days of misery, we finally got my granddaughter returned to her now-well parents, and everything was fine for the next 24 hours.

Then my son awoke on Wednesday saying he ached all over and he had a fever of 101.

Here we go again.

I took him to the doctor today because he still has the fever, but he decided to upgrade his illness and added on bathroom trips for explosions from both cannons if you know what I mean.

The trip to the doctor was mainly due to good old Murphy. He's got some stupid law that mandates a child who is slightly ill on Friday will become deathly ill before the doctor re-opens on Monday. However, this law can be overriden by actually seeing the doctor on Friday thus nullifying the death sentence and causing the mother to appear to hover like a helicopter.

Worked like a charm. The nurse had him blow his nose in a cup (ewwww!) and whatever they did to test it came back saying he has Influenza type A. Great. The bug now has a name.

It has to have been the same thing I had. I did feel nauseated and a little dizzy and very achy and had a fever that for all the world wanted to be 101, but never quite got there, always stopping at 100.8.

Which leads me to the conclusion that my immune system is in better condition than that of my 10 year old son's. I fought this bug off without hardly breaking a sweat and mostly in my sleep.

That's the good news.

Now, after all this, and walking around with a swelled head about how profoundly superior my immune system is from that of the average person, my liver has delivered me a possibly crushing blow...

I get a phone call from the trial coordinator and it's nowhere near my next scheduled appointment date. After swapping our viral stories about how our families have been ill, she got down to brass tacks.

It seems my blood work came back from my last appointment and my liver enzymes (which have never in 3 years been an issue in this study) were slightly elevated. EEEEEK!!

I have to come up for another blood draw next week and hope that the situation has resolved or at least plateaued. Otherwise who knows. She did say that at the current levels I'm not in any danger of having to get off the meds. But she's looking at my blood from a month ago. Who knows how much more *elevated* those little buggers could have gotten?!?

And here I have been worrying all along about losing the medicine due to no medical coverage once it gets approved. I may not last that long!

The only thing I can say that has changed since 6 months ago at my normal liver enzyme levels is my recent discovery of Jello Shooters.

I started making them for John to take to his weekly poker game and naturally I had to sample them to be sure they were fit to serve.

Well, one thing led to another and my friend Karen and I decided that Saturday would be our Jello Shooter making day so that they would be ready for John on Sunday. After all, sampling the recipes is more fun with a friend.

I'll be trusting everyone else's opinions from now on, just in case the combination of Fingolimod and Jello Shooters is what has my liver in an uproar. Sigh. It was fun while it lasted, but I'd rather be on Fingo than hopped up on Jello. The choice is a no-brainer, fortunately for me.

I'll be sure to post back when I find out the results. Not sure how long it takes, but it's been weeks since I had the blood draw they called me about today, so I'm guessing it'll be another several weeks.

Maybe between now and then I'll find something inspiring to blabber about on here...

A Modicum of Happiness

2010-03-08T19:28:00.002-05:00

My day starts early. 5am to be exact. Some of you will say "that ain't early (if you have poor grammar)" and others will say "OMG I thought that was still considered the night before."

When we moved in with my elderly mom last summer I knew it would be like this since we moved 20 min. in the WRONG direction from my son's school which was already a 15 min. drive. PLUS, add on top of that the fact that he's now going to middle school and they begin their day even earlier than grade school and you have 2 very squinty-eyed yawning people every morning in this house.

But we have both figured out a way to approach this that I truly believe my MS taught me. The trick is to look for the good.

We each have a travel mug and mine's filled with decaf and his has hot cocoa.

The drive is long, true, but it's also beautiful. We start out walking down the wooden walkway that my boyfriend built last summer. It's like going to one of those nature parks where there is a deck-like path that winds around through the wilderness. The view from this walkway is spectacular and always sets the mood.

We get in and drive the winding road to town surrounded by alternating patches of housing developements, wild Florida woodland, and farmland where the locals grow corn, potatoes and cabbage.

We merge onto the 4 lanes of HWY 17 North and head into the small town of Palatka. (Prounounced like the sound of a tall cow crapping on a flat rock -- Puh LAT kuh).

We crest the Memorial Bridge over the St. Johns River where we never cease to be amazed at the beautiful sunrise surrounding us. Even on the rainy gray days, we still find reason to be in awe for on at least one occasion we were enveloped in a cloud atop the bridge (just fog really, but if my son wants to think it's a bona fide cloud he can).

And we aren't even half way there yet!

We drive along, sometimes singing, sometimes practicing our jokes on each other, always talking in character voices, and never ceasing to make each other laugh. He especially likes my Elmo impersonation and I really get a kick out of his ailing, grumpy old man he invented named Mr. Abernathy who loves oyster crackers, reminisces about the days when a dollar could buy you anything, and is constantly complaining about today's youth.

One time he made me laugh so hard I had to pull over to catch my breath and wipe the tears from my eyes. All the while, *Mr. Abernathy* kept complaining about how I was going to make him late for school, "goll durn it!"

Anyhow, we turn off of 17 and head out State Road 100 W. where it's so rural I have to make certain I have gas before the turn off because it's 15 more miles to the school without a gas station in site.

The road is lined the whole way on either side with stands of pine forest planted by Georgia-Pacific and other sections that have scrub oak, palmettos and other trees native to the area. You feel like your going "over the river and through the woods to Grandmother's house we go.."

There are power lines along one side of this road and the trees have been trimmed away to keep from touching them.

Now I don't know if it's just us, but I swear to you that whoever is trimming the trees learned how to do it working for Disney.

The first unusual tree we come to is the Dinosaur Tree which stands with a thin neck above the rest and hangs out over the road like T-Rex. Next comes the Elephant Tree complete with trunk that snakes first down then up in an S curve.

Last but not least is our favorite of all. The Turtle Tree. His head looms over the road with an open mouth grin sporting one tooth hanging down. In the distance beyond this tree is another sculpted growth that creates a "wing" on our turtle when everything lines up just right.

We know when we come to the Turtle Tree that we are very nearly there. We prepare to slow for the school zone and he starts zipping up his jacket and gathering his binder and other school supplies.

I bring my camera on these trips so I can take pictures if we have time and if I remember. For that reason, I have none to post yet.

It's an amazing ride that is always the same and yet always different. Sure, we could look at it as the ride that takes an hour round trip at a time of day when I'd rather be sleeping, but we both have learned to embrace it and look forward to it as our own personal time together. No computers, no chores, no rules really... just fun.

And only 35 minutes after it began, our morning ride is over and it's time to head back. We say our "I Love You"s and he begs me not to embarrass him (again) by yelling it out the window in my Elmo voice. And then he's gone.

I turn the car and head back the way I came, but the ride home sucks. I've seen everything already, there's nobody to talk to and the sun is in my eyes. Hey, I did entitle this "A MODICUM of Happiness".

The flip side of anything is never that great. Just look at all the 45's we never played the *other* side of.

My MS taught me to at least TRY and make the best of things. During this MS Awareness Month, tell me, what has your MS taught you?

My Eyes

2010-03-05T08:34:00.002-05:00

Last time I posted was shortly after my last checkup where I had my eye exam and got a lot of visual side effects along with a headache I was told was a migraine.

A few days after this event I had to take my mom to see her eye doctor.

It seems every time we go to see him the conversation inevitably turns to my clinical trial. This visit was no different. When I saw him putting the dilation drops in my mother's eyes it made me blurt out right then and there:

"Hey doc, that reminds me... have you ever heard of someone getting a migraine caused by using those drops?"

To which he replied "It can happen, but it's not a common side effect. Why do you ask?"

I proceeded to tell him about how I got this centralized headache over my brow area and my eyesight got really blurry, light hurt my eyes, and anything bright was surrounded by a halo and had a "star filter" effect ( where all lights looked like star bursts).

His curiosity piqued, he rolled across the room toward me on his little round stool. Peering into my eyes, he brought his light in from the side and shone it into my vision starting from the peripheral edge.

He said he thought I should have been checked right then and there at my visit in question for having a Closed Angle Glaucoma Attack.

He said I had all the classic symptoms and that it would be more likely than a migraine especially since my *migraine* was on both sides of my head.

Being the hypochondriac that I am, I wouldn't have done my self-proclaimed title justice if I didn't worry myself into being totally convinced I was on the verge of going blind (<-- I had to edit that because I have a typo that said "blonde" heh an even SCARIER proposition).

Naturally, I went home and googled it to death.

He said there were tests that can be done right in the eye doctor's office and the cure for it is poking holes in your iris (the colors part) with a laser (eeek!). Like I want to be the freak with 3 pupils. But better I can see than not.

So I called my clinical trial coordinator and she was not concerned at all. She said my eye doctor for the trial would have checked for that (I thought the same thing) upon hearing of my headache. In fact, I told the doctor about the headache when she was looking into my eye with what looked for all the world to be one gargantuan eyeball of her own, but turned out later to be just a large magnifier (much to my relief).

The trial nurse said that this doctor was SOOOOOOOOOO good (everybody: "HOW GOOD WAS SHE??") she was so good that she actually caught early stages of glaucoma in ANOTHER trial patient (I could have sworn she meant this very SAME trial) and the patient didn't even exhibit any symptoms.

While this might seem a comforting fact to my clinical trial nurse, she obviously is NOT versed in the workings of a hypochondriac's mind. For I immediately jumped to the conclusion that Fingolimod must cause Glaucoma. Otherwise, if I had a suspicious episode AND another patient was actually diagnosed, it stands to reason it's the drug (in my mind, warped by hypochodria).

For now, I'm letting it slide. She said she'd run it by the doctor and see if she wanted to reevaluate me. I haven't gotten any return call asking me to drive up there, so a) she forgot to say anything or b) she didn't think it was necessary.

I go back for another eye exam in either 3 or 6 months and you can bet I will keep an EYE on the situation until then. Much as I plan on keeping ABREAST of the situation with the mammary cysts.

If anything new happens, I'll be sure to post it. I can't remember ever having quite that spectacular a change in my vision from dilation drops before, but I may have now worked myself up in to false memories of just how bad it really was. For one thing, I DID drive myself home so it's not like I could have been having that bad of a time, could I?

I know one thing I am sure of. I have a new reason for a panic attack at my next clinical trial checkup. I never would have guessed I'd be terrified of eye drops.

FTY720 TRANSFORMS ext. phase checkup at 6 mo into 2nd year

2010-02-24T17:15:00.003-05:00

Went for my trial checkup yesterday and had great results!

I didn't quite beat my best time on the timed 500 meter walk of 11 min 46 seconds, but I sure gave it the old college try. I was limping and stiff legged by lap 12 (out of the 25 laps of the hallway that somehow equal a distance of 500 meters).

I ACED that MSFC test where you have to listen to a recording of a guy spouting numbers every 3 seconds. Your job (if you choose to accept it) is to add the 2 numbers he said together, say the sum out loud, then throw away what you just said and concentrate on the last number the guy said so you can add it to the next one he says... it goes something like this.

Guy: 3
Guy: 7
Me: 10
Guy: 5
Me: 12
Guy: 5
Me: 10
Guy: 9
Me: 14

...and so on

It can get very hairy when Recording Guy starts saying things with double digit answers. All that math can wear a girl out! And I'm not good with adding 9 to anything although logically it should be as easy as adding 10...minus 1.

At one point, in the middle of the test, I faltered and couldn't come up with 9 + 6 = 15... and while my brain was farting, he spouted another number. I quickly said "15!" and then had to remember that he was still saying numbers... I was able to blast out 3 correct answers in one massive breath and get back on track.

It was close, but I scored 100%. :D

The clinical trial nurse shared with me that she once administered the test to another trial patient who is a school teacher and she failed so miserably she broke down in tears. I can really relate to this as the first time I took the test I didn't know the *trick*. Since I devised The Trick © I haven't failed yet.

It consists of simply saying the answer necessary and "throwing it away" only to repeat over and over (in my brain) the number the guy just said... so it would go something like this:

Guy: 4
Guy: 8
Me: 12 (8 8 8 8 8 8 8 8 )
Guy: 9
Me: 17 (9 9 9 9 9 9 9 9 )

And that's all there is to it. Since concocting The Trick © I now no longer fail this test, my hair is growing in thicker, I have made a fortune on Wall Street, and my boobs are 3 times their normal size.

You're more than welcome to use The Trick © but be forewarned: your mileage may vary.

Other highlights of my visit included the animated discussion of the new name "Gilenia" which I stated sounded like LymphopENIA or some other such medical deficit. My clinical trial nurse said to her, it brought about the image of GardENIAs.

I told her that unless they put a flower on the box, I'm going to be sorely disappointed.

I had my PFT performed by a new guy who asked me if I could teach him how to administer the test and then, after a big ol "Ha Ha!" about that... I ended up having to teach him how to administer the test.

Well, at least the part with the flute that you have to measure peak inspiration and expiration. That thing that looks like something a pothead might get some bright ideas about how to turn into a bong... It is a clear plastic cylinder with a hole in the side, open on one end and closed on the other and hooked to some plastic tubing that in turn connects you to the machine that knows everything... every little breath you take, so to speak.

The point of the test is to breathe normally, and then take a big breath and cover the hole in the "flute" with your finger for a couple seconds during peak inhale or exhale, to create resistance, thus in turn, measuring your lung function.

We kept getting the timing off and I was getting my cardboard mouth guard soaking wet and soggy. That's when I told him "you're not doing it like the other guy does it."

He perked up hoping for an answer to how to get this old stupid dog to perform his new trick.

He said "how'd he do it?"

I said "He said 'Breathe nomal, finger over the hole, deep breath in, finger off.'"

It was like a light shone down upon him from the heavens as he had his eureka! moment. You'd have thought I just gave him the secret to the universe.

Then his eyes narrowed to little, untrusting slits.

"If you KNEW that, why didn't you just DO that?"

To which my reply was "I was the one having to breathe. You can't expect me to breathe AND think at the same time, can you?"

With the test completed he walked me to the exit door, thanking me for actually teaching him something about communicating his directions to patients better.

I told him he'd be getting my bill in the mail.

Then on to the eye exam. Well actually I got it all out of order since blood draw was first, PFT second, EDSS and patient questionnaire was next, and then eye exam last, but that's the power of being an Author. I can relay it any way I like. And since I have short term memory issues, I'm not worried so much about order of events as much as I am ecstatic that I can recall any of them.

So, where was I? Oh yeah, the eye exam. There is one important reason that I remember distinctly that this was the LAST test of the day. Because I had my eyes dilated so much I had to sit in the parking lot for an additional hour in order to allow them to adjust enough to attempt a 2 hour drive at dusk in rush hour 6 lane traffic.

The eye exam was not anything to speak of really. I was in and out and given a clean bill of eye health in a relatively short time (in waiting room years).

But the part I really remember was getting the drops. 3 kinds. One to numb me for the pressure test, some yellow stuff to see what, I don't know (but it really freaks you out when you wipe your eyes with a Kleenex and then look and see fluorescent yellow stuff on it. Eeek!) and then the drops to open up the pupils.

After I got the drops, within a minute I could feel them draining into my sinuses. And within another minute my head started to hurt. Just mildly at first, but snowballing into a big old headache of peculiar intensity.

I asked the doc when she was shining that bright light in my eyes if it was normal to get a headache from the drops.

She asked "do you have a history of migraines?"

To which I said "yes", but was thinking "well DUH! Read my file, would ya??"

"Oh, well those drops can precipitate a migraine so be sure to get some sunglasses on the way out."

So I left there looking like I just came out of a 3D movie that I really hated. I had the stupid glasses but all I could do was frown.

I made it home somehow. My vision looked a lot like this only you had to add in a squint factor since it was making my headache worse:

How I managed to get hom without a huge game of bumper cars is beyond me.

I still have the headache today, but luckily my vision has returned to normal.

All in all, it was a pretty good day. I liked all my results and all the people who work with the patients in the trial are great to be around and fun to talk to. Everyone has a good sense of humor. Of course, they have to if they are going to be dealing with the likes of me. :D

The lead investigator, when I told him I would be making him my regular neuro after the trial ends responded with a big smile and quipped:

"I'll be sure to call in sick that day."

Gilenia? Are you serious? You'll always be Fingolimod to me.

2010-02-22T19:12:00.002-05:00

This little tidbit just hit my inbox courtesy google alerts....

Novartis Oral Multiple Sclerosis Development Compound Gilenia®* (FTY720) Granted US Priority Review Status

Really??! Is that the best you could do? How the hell am I going to remember Gilenia? And I'm not crazy about the "enia" suffix. Sounds too much like a depletion of something vital to my system. Conjures up negative connotations. Sure, I realize that it does create lymphopenia which is the primary medthod of action, but come on!

I was hoping for a little more glitz and glamor. May as well just stick with Fingolimod (which I will no doubt do).

And is "Priority Review" a fancy, scientific term for Fast Tracking? Does this mean evil people at the FDA are reading my blog and rubbing their hands together and laughing their insidious "MWAHAHAHAHAHAHA!" knowing full well that the end of the review process marks the end of my Pharm Party?

Say it ain't so!

Oh yeah, I almost forgot... Here's the story that goes with that headline:

. US Food and Drug Administration grants priority review status after accepting US regulatory submission for 0.5 mg once-daily Gilenia (fingolimod)
. US and European Union regulatory submissions completed in December 2009 for Gilenia include more than 4,000 patient years of clinical trial data

Basel, February 22, 2010 - Gilenia®* (FTY720, fingolimod) has been granted priority review status by the US Food and Drug Administration (FDA), which accepted the regulatory submission made in December 2009 for this medicine. Once-daily Gilenia (0.5 mg) has the potential to become the first approved oral therapy for the treatment of multiple sclerosis (MS).

The FDA grants priority reviews for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists. As a result of this designation, the standard 10-month FDA review period will be reduced to six months.

Since Gilenia involves a new active ingredient (New Molecular Entity), the FDA is likely to require an Advisory Committee meeting and evaluate the risk management program, which could result in the FDA extending its review at the end of the six-month period in June 2010.

"We welcome the decision granting priority review to Gilenia, which underscores the potential benefits of this medicine to patients," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "MS is a leading cause of neurological disability in young adults, particularly in women, and this medicine has the potential to offer real advances in the care of people with MS."

Approximately 4,000 patient years of experience have been gained in MS clinical studies involving Gilenia, with some patients now in their sixth year of treatment. Data from one of the largest-ever Phase III clinical trial programs conducted in MS patients were submitted to support the US and European regulatory submissions, including results of the TRANSFORMS and FREEDOMS studies that were recently published in The New England Journal of Medicine[1],[2].

Combined data from these studies provided evidence of the efficacy of Gilenia in reducing relapses, disability progression and brain lesions in patients with the relapsing-remitting form of MS as well as safety data. Approximately 85% of patients with MS are estimated to have the relapsing form at the onset of disease[3].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "priority review," "potential," "could," "will," "likely," or similar expressions, or by express or implied discussions regarding potential marketing approvals for Gilenia, or the potential timing of such approvals, or regarding potential future revenues from Gilenia. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Gilenia to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gilenia will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that Gilenia will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Gilenia could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

The brand name Gilenia has been provisionally approved by the FDA for use in connection with the product, but the product itself has not received marketing authorization or NDA approval from any regulatory authorities.

References
[1] Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version).
[2] Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version).
[3] National Multiple Sclerosis Society website. http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx. Accessed January, 2010.

Just how long....?

2010-02-21T06:49:00.003-05:00

...Can a person taking Fingolimod expect to be in remission?

I think about this question A LOT lately. This has been the longest period of remission in my MS *career* (it's kind of like a job since dealing with it every day sucks), and I can't help but wonder when it's going to end.

Yesterday marked the 2 year, 6 month mark since starting the trial, and the 2 year, 10 month, 16 day mark since the start of my last MS attack. To me, that is insanely fantastic. I still can't get over it and (other than the part about being broke and knowing it's NOT true), I often feel like I have won the lottery or something. Well, I am winning the MS lottery I guess.

If I were a character in some video game and the cruel kid playing forced me to choose between the More Health potion jar, or to go around finding bags of gold coins, I'm taking the health every time. It's only logical that running around gathering bags of gold coins all willy nilly without regard to your Health-o-meter getting low and turning red will only result in a premature Game Over message...

Fingolimod has restored my Health Meter back into the green zone and I just don't know when the MS monster is going to poke it's head back up in this game and bite me on the butt, sending my health meter into a downward spiral.

I read somewhere on the internet (so it must be true, right?) that FTY-720 has residual effects. Some lab rats somewhere (the furry version, not two legged) were followed after being given the drug to see how long the stuff stayed in their system and had a beneficial effect. If I recall correctly, (and don't hold me to this because I can't recall correctly why I went into the kitchen and stood in front of the pantry a few minutes ago), it seemed the length of time it had a beneficial effect depended on the length of time one was on the stuff.

It would really be cool if you could spend 3 years taking it for 6 years of coverage. Maybe this trial will drag out for 10 years (please oh please) and, when the magic Fingo carpet gets yanked out from under me, I could have 10 years of residual protection.

That's probably too much to ask. It's probably more like a guy taking off a condom and saying "the residual effects of having warn it will guarantee that you are safe from STDs and becoming pregnant, I swear!". Guys. They'll say anything won't they? (JUST kidding, okay? You men out there don't need to send me snarky comments because I made this drivel up.)

Back on topic... It used to be that, way back at the start of this trial, if I so much as sneezed I would cringe and duck and wait for the wrecking ball with the big "MS" logo on the side to smash me where I stood. I used to have pretty ferocious attacks which were precipitated by nothing more than a head cold or stressing about money. It was only natural, when I experienced these triggers, that I would brace myself for the wallop of a big old relapse.

I think it was somewhere around the beginning of the second year into the trial that I got a cold for a couple of days and realized it came and went and I didn't even worry about an MS attack.

By God, this stuff has more power than I thought! It has the power not only to leap tall buildings in a single bound, but, more importantly, to force me to feel normal again.

The average person, health meter intact and never drained by a chronic disease, cannot realize what a precious gift they possess. They run around with a green, sparkly health meter over their heads never even aware they could ever turn to yellow or red. To have "normal" health is taken for granted.

To have something like Fingolimod put this green, shiny almost-as-good-as-new health meter over my head and allow me to run around (literally!) in this big video game that is my life, to me is just incredible.

Maybe it's got something to do with the other lifestyle changes I made at around the same time as starting the study (i.e. quitting smoking) and the fingo's got nothing to do with it? Who knows. Maybe the simple act of laying down the coffin nails and not cramming something lit on fire into my mouth so I could suck the soot and ashes of it into my lungs was enough to make the MS monster say "Ahhhhhhh!" and go back into his cave and hibernate. Maybe.

But I'm not willing to give up that little pill in order to find out.

I never thought when I got into this trial that I would become so affectionately and emotionally attached to an ugly Chinese fungus, but I have. The day this all ends will be a sad one indeed.

So I'm wondering... don't they need to do a reeeeeeaaaaaaaalllllly long term extension study (say, hmmmmm, til I die maybe? <--omg I HOPE that's going to be a really long time (frantically seeking wood on which to knock!)) to see how long this stuff can keep a person in remission? Come on! Nearly 3 years with no relapse? That's gotta be some sort of record. Well, for me at least I KNOW it is. The longest I went before that was the first 38 years I lived, but that doesn't count because it was pre-diagnosis.

I propose a study called "JERI" or Just Exactly how much time Remains In which patients from the phase III trial can go between relapses? (See, Novartis, you aren't the only one who can come up with those catchy trial names! I figured out how you do it and before that I thought it was cheating to use letters out of the middle of a word for your acronym).

Anyhoo, what better person to have in this extended, last until she's dead, Phase Infinity trial than the person's whose name matches the acronym? Eh, see? Great idea, no?

In case that idea never makes it to the board room, my only other option is to hope the FDA takes their sweet time. I can't bring myself to wish that selfish wish, though, because there are TOO MANY MSers out there waiting to quit jabbing sharp metal objects into their bodies repeatedly.

Ya'll are just going to love this therapy. You pop the teensy tiny capsule, way smaller than a vitamin, and take a sip of water. The capsule floats in your mouth and when you swallow you have to check around with your tongue to make sure it's gone. You never felt it go down.

It just doesn't get any better than that.

I'm praying I can go forever without another relapse on this stuff.

That said, watch. I'll be crawling back to this computer chair tomorrow to try and bang out H-E-L-P M-E-! on the blog.

Cringing and ducking, I'm outta here... to go have a NORMAL, BORING DAY. YAY! I've won the Lottery.

Oh and I forgot this one...

2010-02-19T23:35:00.003-05:00

In referring to that huge jug of castor oil my goader sent in the last message, they followed up with this image.

In response to that, (and I WILL respond right here because no doubt you are reading this, you-know-who-you-are, and will see it) I post this picture:

Honestly, my Personal Goader (a personal trainer for the constipated blogger) is so funny themselves, they should be the one writing the blog.

I get my material from everyday life and life's not been funny lately.

If I think hard enough and try to remember some of the stuff that's happened since last month, I bet there have been lots of things I could have turned from disaster/tragedy into a humorous "Life In These United States" moment.

If I didn't laugh I'd be crying all the time no doubt.

Oops! I Did It Again!

2010-02-19T17:46:00.003-05:00

I said I wasn't going to slack off and let the blog go stale, but here I see I did it again. Doh!

I have a friend, (who shall remain anonymous) who has been prodding me, pleading with me and downright GOADING me to write again and I just have to share some of the little comments they've made these past few weeks...

Thinking my blog STINKS because it's sitting here wasting away, they sent me this picture...

Then, in another message, I was made aware by visual imagery that things needed to be freshened up...

I love the mouse in the picture, who I assume represents me, kind of sticking with my theme of being a lab rat.

When I wrote back in self defense that I was suffering from Writer's Block and that nothing would come out... I got this:

EVERYBODY'S A COMEDIAN! (or in this case, commodian)

So, there are no more excuses and I am going to return to the world of posting in order to post, whether or not I have anything informative or intelligent to say (it's never stopped me before, just read the rest of my blog).

Anyhow, I hope I haven't been dropped from everyone's blog roll as being DOA.

I still have a few more things to say...

Is my microphone on? I'm just warming up, and I'll be here all week.

Be sure to tip your waiters and waitresses.

For now it's closing time and you don't have to go home, you just have to get the heck out of here.

Night all.

Jeri

PS, It's good to see you again. I've missed you.

Mixed Emotions

2010-01-21T13:02:00.004-05:00

I know I haven't blogged in a while but life has been driving me crazy since my major source of income dried up.

Just a few minutes ago, I walked by the TV where my mother was watching Fox News and I heard the words "MS" and "new pill". This perked me right up so I grabbed the remote, punched up the volume and sat back to soak it all in.

They didn't mention any names but said that 2 new pills were competing for first ever FDA approved ORAL treatment for MS. A doctor showed an MRI and described in grade school terminology the basics of the disease and what the pills do to combat it.

They spoke of a "news release today" that I was unaware of and so I sat down here to google.

My heart lept into my throat as I did a Google News search to find out that Novartis has filed for FDA approval of Fingolimod / FTY720 yesterday, January 20, 2010 -- exactly 2 years and 5 months to the day since I swallowed my first pill.

This is great news, however I am terrified by it. The clock is ticking on my free ride and I know it's silly because it's not like the FDA is going to just rubber stamp this today when it hits the big guy's desk, but it's a huge reminder that this trial is not going to last forever and I'm not going to get this stuff for free forever either.

I have GOT to get that letter done (the one I drafted and then set aside to go over again a few times but haven't yet gotten to) so I can send it off to the CEO of Novartis and ask him to help a guinea pig who's down on her luck out with a lifetime supply of Fingo.

I just don't want it to sound too whiny but ever time I read it, it sounds all "woe is me" or is that "WHOA!"?

Anyhow, when I get it written, I was toying with the idea of posting it for all to see here on the blog, but don't know how that would effect the results....

Any ideas you readers (if anyone still reads this) have for getting Novartis' attention and persuading them to give me drugs, please post them as a comment -- I'm all ears!

This has been a wonderful journey for me. I don't want to revert back to relapsing every 3 months and being chronically under the dictatorship of so many horrible symptoms. I would rather die than go back there.

When Novartis yanks their Magic Carpet of Fingolimod out from under my feet, I just know I'm going to fall into that dark, black, bottomless, horrifying pit of MS again.

I'm scared. Someone tell me how to keep that carpet, if you know a way!

Here goes nothing. I'll be on the edge of my seat following right along as we wait and see what the FDA has to say.

Cross your fingers, would ya?

I'm Number 1! I'm Number 1!

2009-12-24T08:30:00.004-05:00

Everyone! Put on your big foam fingers and chant along with me! I'm number 1!

(No, she's not gone off her rocker... yet.)

I had my trial checkup last week on the 16th because waiting until the 22nd as planned would have meant I ran out of my drugs before I could see my ~~supplier~~, er, trial coordinator.

This time I took my friend Karen (whose dearly departed husband I blogged about here) with me. She and I have been friends for at least 25 years now as she has pics to prove it even though my 11 year old swears that's a young boy in that pic. Can I help it I was more *svelte* back then? (ok, flat chested and narrow-hipped with a hairdo like David Cassidy) We just sort of went our separate ways about 15 years ago when everyday life wedged itself between us. Joe's death brought us back into each other's circle again.

So, she went with me on the long ride there and we had a ball. Amazing what stuff you carefully spend decades trying to forget -- and with the help of MS cog fog you successfully do -- until you meet up with someone who likes to say "remember when you _____(fill in the blank with some stupid thing you did)? That was funny as hell!" Glad I could amuse in an everlasting way like that. heh

Anyhow, the checkup was pretty much SOP with nothing new to learn. She had already told me of the unblinding of my TRANSFORMS phase III extension phase study and I know now that I have been on Fingolimod at .5mg for the entire duration. Nothing new to surprise me there.

Then I had my EDSS performed by the same neuro I had last time. She's a young lady who appeared to have swallowed a watermelon last time I saw her. She knew of my having been the last patient the eye doctor (for the study) saw before going into labor and so she had asked if I could rub some of my mojo on her hand because she, also, was due and ready to pop.

When I saw her this time, she's back to her skinny self and her baby is only 1 week younger than the 3 months it has been since we last met. My mojo once again worked and the legend grows exponentially.

She started doing all the follow-my-finger (not to be confused with pull-my-finger or that could be embarrassing) stuff and the exam commenced. Nothing remarkable to speak of.

The whole time I was explaining to Karen how I've always been amazed at the weird stuff they have me do and that I've always asked questions about what each test meant. Right about that time, the doctor was having me take the heel of my left foot and run it from knee to ankle down the shin of my right leg.

I said "I have no clue what she's learning from this tho." and Karen, not missing a beat, said "that's the test to see if you're sexy." My neuro burst out laughing.

She also had a good chuckle when she got to the question they always ask and I always (before) gave the same answer.... "Are you having any sexual dysfunction?" she asked.

"I don't know. I haven't had sex in 3 years." was always the answer before. This time, I had told Karen about that particular question/answer on the drive up and she gave me an idea for an alternative answer.

So, the neuro, staring at her clipboard with her pen poised to check the little box, asked me "Are you experiencing any sexual dysfunction?"

And, without missing a beat, I asked "Do you mean WITH someone?"

A good laugh was had by all.

Then came the 500 meter walk, otherwise known as "Walk this hall 25 times or until you drop dead." Karen was going to walk with me but she's got Oyster Foot and didn't feel up to it. (what's Oyster Foot? She got her foot all cut up years ago jumping from a boat into shallow water wearing only flip flops and got some bacteria in there that apparently won't ever go away and causes a constant pain. huh, I didn't know there was such a thing).

So I walked the hall myself and Karen stood at my exam room door doing cheers each time I passed by. On the final lap, she darted into the bathroom just across the hall from my exam room and nabbed a roll of toilet paper. Whirling off about 4 feet of paper, she jammed the end with the roll still attached into the file holder that was mounted on the wall beside my exam room and strung the rest like a finish line across the hall.

As I approached, I raised my hands in the air in victory and noticed she was humming the theme from Chariots of Fire as I broke through the paper finish line.

Giggling uncontrollably, I wadded up my "finish line" and jammed it into my totebag as a keepsake of the most rewarding 500 meter walk I have had in the trial. I told her I'd be reaching into my purse and whiping my nose or other unmentionables with my treasured finish line before I remembered what I saved it for.

As I was leaving, I asked the trial coordinator if I could know what my EDSS score was now that the trial was unblinded.

It was the best news yet! I'm a 1! (0 being normal and 10 being dead) I'm a 1!!!!

I'm Number 1! I'm number 1! And I owe it all to this pill. Amazing! Simply amazing!

Amazing News I Knew All Along, or the Unblinding of the TRANSFORMS Study

2009-12-09T09:21:00.003-05:00

I was supposed to head to Jacksonville for me quarterly clinical trial checkup in the TRANSFORMS FTY720/Fingolimod study today. Rarely do I have to reschedule -- in fact I can remember only 1 other time in the past 2yr 4mo since the trial began and that was because of a hurricane.

This time I was faced with my 11 year old getting off a school bus at noon with nobody to pick him up if his mother was in Jacksonville.

The schools do this quirky thing as they have ever since the 2004 hurricane season when so many storms crisscrossed our great state of Florida. They now make the school day last 15 min longer every day, and if we have no days off due to inclement weather, school will let out 1/2 day early 1 day a month... always on Wednesday for some stupid reason. It couldn't be a Friday so we could plan a long weekend or something. It has to be Wednesday when people who work for a living have to find time to go get the kids and then find someone to care for them until their parents get off work.

Not that I have to worry about that because the only job I have that I can't get up and walk away from at the drop of a hat is caring for my elderly mother. And she's pretty self sufficient anyhow, so I can get up and walk away from that, too.

But I digress.

I didn't have anyone to pick my son up since my other son's car broke down. So I had to call my trial coordinator at 3:00 on Tuesday to see if she could reschedule my 9am Wednesday appointment.

Usually when I call I get her voice mail, so I was pretty much figuring I'd just have to take my youngest out of school all together for Wednesday and drag him to my exciting and ultra educational clinical trial. Sort of a science project field trip. At least that was how my mind was whirling as I tried to justify that approach.

But she answered on the first ring and had no problem moving my checkup to the 22nd instead.

"Since it's just a blood draw and your EDSS it's not a problem. Now, if it were an eye exam, that would be another story since that doctor is so backed up."

"By the way", she said, "I was going to call you today anyhow..."

(and I'm wondering WHAT NOW??!! and worried to death.)

"Novartis has changed the trial again." (so now I'm thinking I have another War and Peace sized Informed Consent to re-sign).

She continues on...

"They have unblinded the study and you are now in the Open Label Phase.

OH CRAP! was my first thought. The party is nearly over and I'm having way to much fun to take off my lampshade and go home. I'm hoping I can feign losing my keys in Novartis' couch and talk them into letting me just hang out for a really long time in their comfy clinical trial confines. With all the nice people who have become my only social circle outside of immediate family. (yes, I already know how pathetic that sounds, but the truth can be ugly).

Then she proceeded to unveil, without so much as a drum roll, the results of my particular study.

Seems she was just finding out what I've known all along. I've been on the Real McCoy since the first day of the trial, and the lower of the 2 doses at that. Just what I prayed for and got (unlike the pony when I was 10, but this is waaaaaay better in my opinion).

The choices were:
1. High dose Fingolimod (1.25mg)
2. Low dose Fingolimod (.5mg)
3. Avonex (the interferon already approved and on the market, used as a comparison)

I knew I wasn't on the Avonex because I never had the first side effect. Not any injection site irritation (beyond the "OUCH" that you would expect from a 2" needle) nor any of the notorious *flu like symptoms*.

And I was pretty sure that I must be on the low dose Fingo because I'm the same person who needs a quarter of the weakest Xanax they make to take the edge off for an MRI. In other words, just let me sniff the pill bottle and I'm good.

And now I hear that they are converting everyone in the trial to the low dose. If you were on high dose through the initial phase (where we all had to do the once a week shot and take a pill every day) you would have entered the Extension Phase on that same high dose. Now, however, you will be put on the low dose.

So that way, no matter what any of us started out taking, we are all going to be singing the Fingolimod Praise Song as one unified chorus all on the same drug at the same strength.

And sing it's praises I will!

I have now gone the longest length of time between relapses ever. No relapses in the 2 years 4 months of the study and my last one was in April 07. Another 4 months and that will be THREE YEARS RELAPSE FREE! Oh my God it's just like being given my life back! Nothing short of a miracle in my book.

Novartis, if you are listening, THANK YOU for the opportunity to be in this study. Thank you for pursuing it as a treatment for MS and thank you for giving it to me for free for life.

Ok, ok, I may have jumped the gun on that last part since you never said anything about that, but you have given me a taste of the good life... far more valuable to me than if I had won the lottery or any other material gain. You have allowed me to run and jump again, to get a head cold and not cringe in horror waiting for the relapse that always used to follow, and you have allowed me to keep up with my kids and grandkids in a way I never thought would ever be possible again.

It's going to be a sad day when I have to say goodbye to the clinical trial staff. They are my friends. But what I will miss most is that precious pink pill I have so long paid homage to here.

Because I don't have insurance and won't be able to pay for it again.

I will feel like Algernon, I'm afraid.

But thanks for the 3 years of high Quality of Life your trial did give me (I'm assuming you won't kick me out before it's over so that's why I'm saying 3 years).

Hey! I have an idea!! Don't you guys need someone to be on this long term to study, so you can see the cumulative affects over many many years?? I'm your volunteer!! And all it will cost you is one pill a day.

I'm easy like that! :P

Blowing the dust off

2009-12-06T15:56:00.002-05:00

And blogging again.

Sorry I let 2 months go by without so much as a peep. Rumors of my succumbing to side effects from the clinical trial drug have been greatly exaggerated (to paraphrase Mark Twain).

Since we (I) last spoke, I've just been busy with life. Living at Mom's means doing all those normal daily things like cooking and cleaning and doing dishes and stuff on a more regular (like normal people do) basis.

We no longer live smack dab in the middle of town so we can't just *run out* for whatever whim-driven thing we need. No, now logistics and lists and travel routes and plans all come into play. When it's a 20 minute drive to anywhere you want to go, you don't just run out for a gallon of milk.

I'm doing a LOT of driving these days. We moved east by 10 miles from our old place, while we put our son in the best middle school in the county 20 miles in the other direction. So we live a 30 min drive from school. Funny thing is, if he rides the bus, we have to get up 30 minutes earlier (5:30) in order to make the bus on time (at it's last stop 20 minutes from home). But if we drive the whole way we can sleep in until 6 and still get out of the house by 6:30 and make it to school by 7 so he can have breakfast before first period.

I'd rather sleep that extra 1/2 hour and get a 1/2 hour of one-on-one parent/child time in the morning. Of course we spend it honing our improv routines. My son is quite the comedian. It's only gotten him in slight trouble so far. One kid wanted to kick his ass for pronouncing his name with an exaggerated English "hoity-toity" accent. The other kids loved it and asked for a repeat performance. Jack Gogan didn't think it was so funny when he pronounced his name "zjaaaahk go-gaaaaahn" however and we had to give our son the "he's more afraid of you than you are of him" and "if he was going to kick your ass he'd have done it and not talked about it" pep talks.

Anyhow.... I got side tracked. He's a real comedian and I'm proud of him. He makes me laugh on a daily basis.

The other day we got the mail from the PO Box. The one on top was a window envelope that had great big letters on it saying "BILL ENCLOSED". He grabbed the envelope and held it up near his mouth and said "Bill! If you can hear me, we're gonna get you out of there! Just hold on, Buddy! We called the fire department and they are bringing the Jaws of Letter Opener."

I said "hey! At least it's a window envelope so he can see out." To which he replied "I can see through the window that they have your mother in there too... see her name right there?"

So, anyhow, we love our morning drives. And because I do so much driving all the time, I'm away from the house (and computer) more.

And because I don't have any earth-shattering news to report about Fingolimod or my trial, I guess I've just not thought about it.

I'm so BLESSED to be at the point in my life that I've had MS for 10 years and yet I can forget about it. I have no constant reminders other than some stiffness in my legs in the morning (which could very easily be due to age as much as MS).

I think about those MSers who are less fortunate. Who are wheelchair bound or constantly struggling in some other way to deal with their MS on a daily basis and I am moved to thankful prayer. I have to thank God daily that I have a normal boring life again.

And with that normal, boring life I would like to make some kind of mark on the world with the gifts I have been given.

I want to either write children's books or get back into doing my artwork. I used to be quite good and to turn from that and give it up like it's something I got tired of is sort of like telling God I didn't care for that scarf he got me. IT'S A GIFT! I need to appreciate and use it... before it could be gone in a flash. One good relapse and my drawing/painting/sculpting skills could all be a memory.

So maybe I should start drawing again.. and maybe I'll share my creations here. It'll give me a reason to come back and post.

As far as my trial goes, I'm headed up Wednesday the 9th for another poking and prodding session to be rewarded by 3 more bottles of the magic potion.

I heard that Merck got a "refused to file" letter from the FDA in regard to their oral med, cladribine, so that's making it a closer race. The drug companies can fight all they want over who gets to claim their spot in history as the first to offer a pill for MS. The winners are going to be the thousands of MSers who get to benefit from their effects.

Maybe not everyone will be as fortunate as I have been... to have no more side effects from the pill than they get from a daily vitamin... but hopefully they will.

And -- knock wood -- I'm STILL relapse free since April 07. The LONGEST span of remission I've ever had since being diagnosed.

I'm lovin' it.

One Lump Or Two?

2009-10-12T20:01:00.004-04:00

Last Friday morning I awoke with a slight pain in my left breast. It's not unusual for me to be tender sometimes so I really just ignored it although I did remember thinking it was odd the pain wasn't bilateral.

Saturday it hurt a little worse.

Sunday I got to poking around to see if I could pinpoint the actual area of pain since it now seemed to radiate into my entire left breast.

That's when I found the lump.

This thing seemed as big as a ostrich egg to me, but, since my breasts aren't much bigger than hen's eggs I knew my brain was exaggerating.

So then I naturally went Googling for the better part of Sunday and by the end of the day I was convinced I only had months to live.

I wasn't going to tell John or my mother (with whom we now live), I told myself, until I had gone to the doctor and found out if there was anything I should be worried about.

Yeah, right. I cannot keep my mouth shut and within minutes of telling myself to keep it to myself, I was listening to the whole lumpy story poor out of my mouth. Like an uncontrollable case of diarrhea I helplessly sat there spewing forth detail after detail, well, much the same as I'm doing now.

Note to self: check to see if they make Imodium BM (for "big mouth").

Anyhow, I can't stop the story now as I'm obligated to satisfy the reader and I'm sure you want to know if I've been told I only have months to live, right? You do care, don't you? (Please just say you do, whether you do or not. Thanks.)

Monday morning I called the clinical trial nurse to let her know what was up and see if she could get Novartis to pay the bill for a mammogram. I told her I thought you could walk in for a mammogram and not have to have a doctor's order at the local radiology center.

She said that was for "screening" mammos, not diagnostic like she wanted me to have.

She said I needed to get with my GYN and he could do an exam and then write the order for the mammo or ultrasound or both.

I called the GYN and the he could see me after lunch, but the only problem was that when I had to see him back in June and have a pelvic ultrasound, he'd never been paid for the visit. $160 that Novartis promised they'd cover.

So this visit they agreed to see me but only if I forked over $100 cash at time of service. Having a big painful egg lodged in my breast, what choice did I have? Besides, my mother made me go.

I'm telling myself the whole time that I didn't really feel a lump and that's it's all in my head. After all, it's Breast Cancer Awareness month and the pink ribbons are everywhere, along with shirts and bumper stickers and TV specials and news stories. A hypochondriac like me can't HELP but end up with certain breast cancer after being inundated like that.

I don the paper shirt and wait.

The doc comes in and asks me how I am. Why do they do that? Don't they know why you are there and that, because of that, you are having a less than zippittydoodah day? How moronic, eh? He should walk in and say "Life's sucking for you right now, isn't it?" And then he should tell me his is too because his Mercedes is broke down and he had to take the Jag today. We could commiserate.

I tell him the series of events that led up to my sitting on his table in a paper shirt. He listens and scribbles and then has me lie down.

He starts to palpate my left breast and stops at the noon position. "Is that what you are talking about?" he asks.

Geeze, did I miss something ELSE?? I wonder to myself.

"No, it's right about 4:00, or half past 4, but not quite 5," I tell him.

"Holy COW! That's HUGE!" he says.

The red lights flashed and the warning sirens went off inside my head. This guy who does this for a living every day and has done so for the past 30 years or so just said "holy cow that's huge". CRAP! that's NOT good!

All I could think to say was "but it's squishy, right? so that's a good thing?"

And his come back was, "Uh-uh, that felt mighty firm to me."

Great!

He says "The ONLY good news I have for you is that breast cancer isn't NORMALLY painful, but that doesn't mean it can't be cancer. It could even be that you have a painful cyst right up against a tumor."

He went on to say that it was irregularly shaped and not round. His estimate was 4 centimeters by 2 centimeters. (I just now googled how big 4 centimeters is and it's about 1.5" WOW!)

He said an irregular shape and the firmness, coupled with my age, family history of my maternal aunt dying of breast cancer, plus the fact that I haven't had a mammogram since 2000 were all pointing at probable bad news.

He said we'd move on to the discussion of course of treatment after I got the mammo and we see what's what.

I asked if I should get it in town or wait to see if the clinical trial could schedule it for me at Shands in Jacksonville and I wouldn't have to worry about paying.

His response was that we needed the info here if I wanted him to be in on making a plan. It's too hard to get records from Shands. In fact, he never got the pelvic ultrasound results from back in June. Case in point.

He wrote the order and said we'd make a plan when the results came back.

The diagnostic center was just across the street from his office so I went right over to schedule the mammo. I was in luck, they said. I could have it right now.

Great! I really wanted to get this over and get onto the next phase of dealing with whatever the result.

Turns out the nice lady who did the mammo used to work with my mother (before she retired) in the Medical Records department of Putnam Community Medical Center in Palatka, FL. She asked all about Mom and we had a nice conversation while I tried to ignore the fact that she was handling my boobs the whole time.

She did the right side first and it was fairly uncomfortable, but when she got to the left side it was all I could do to keep from screaming. I very nearly drew blood as I bit my lip to hold back the pain in my chest. I was sure she was going to pop that lump no matter what kind it was.

Afterward she told me to stand right there and wait while she went to see the radiologist who reads the diagnostic mammograms while the patient waits.

So I waited.

She came back in and apologized saying "The doctor wants you to have an ultrasound now so he can get a better look at what he's seeing to make a more positive diagnosis. The girl who does the ultrasound work is over helping out across the street at the hospital and we've called her back so she's coming right over."

She had me take a seat in the waiting room and left me with a "hope everything works out ok for you" that just seemed to drip with sympathy.

I did NOT like the sound of that! I've had my share of medical tests done where the tech knew what was going on but couldn't let on that she/he knew anything and this sounded more like "tell your mom if she needs anything after you're dead I'll be there for her."

I sat and tried to get a handle on my fear. I kept telling myself that cancer doesn't hurt. But my mind kept coming back to everyone I ever knew who died of cancer and how they seemed to be in awful pain. I imagined that mine was now painful because of the stage I must be at... past the point of no return.

Oh hell, just bring on the morphine and get me outta here.

Fortunately I only had time to read part of the pamphlet on "Breast Cancer: Your Treatment Options" before the ultrasound tech walked in.

I didn't think anything could hurt worse than the mammogram did, but I was wrong. I actually had tears running down my cheeks as she pressed to get the best view of the lump.

She said she would be right back. She was going to go see the radiologist.

Then *the man behind the curtain* finally appear beside my table where I lay covered by a towel.

He introduced himself and said he was the radiologist.

He told me my breasts were chock full of cysts on both sides. "But you knew that, right?" he asked.

"No, I had no clue." I said, still waiting for him to get to the point.

"That huge lump your GYN felt was a grouping of 4 or 5 cysts all lined up side by side. They are firm because they are very full of fluid. Your breasts build up fluid and the body gets rid of it as your monthly cycle waxes and wanes," he explained. "Your body just isn't very good at taking out the trash."

"We call that Fibrocystic Disease" and that's what I see going on here. The lumps can be painful, tender, sore. I can relieve that pain by aspirating the fluid out with a fine needle. Would you like me to do that now?"

I politely declined. Funny how, since getting into the extension phase of this trial and no longer having to stick myself, I have regained my previous aversion to needles.

"Ok, that's fine," he said. "But if the pain increases and you find it unbearable, you can always come in and have me do the procedure."

I told him I'd keep that in mind.

I asked if Fibrocystic Disease was a precursor to cancer and he said he didn't see anything anywhere on my scans that even hinted at anything cancerous.

I couldn't help myself and the biggest smile ever broke out across my face.

"Oh my God, Doc! I was praying for good news, but I was thinking along the lines of surviving 5 years, not that the news could POSSIBLY be this good! THANK YOU!"

"Hey, I just call it like I see it, it's not me you have to thank." he said as his eyes glanced skyward at you-know-who.

So here it is God: THANK YOU! I owe you one. Well, I owe you more than one, but you know that.

So now I sit here with boobs that have been handled more in the past day than a cheerleader's on Prom Night, and even though they are so sore I'm taking Ibuprophen today, I'm one happy lumpy lady.

And with that, let this be a public service announcement to all you women out there. This is National Breast Cancer Awareness Month and you need to go have that mammogram done.

For about 2 hours of my life yesterday I was absolutely certain that I had a large cancerous tumor in my breast and I now know what that terrible fear is like. I was lucky this time. I could just as easily been sitting here writing about how scared I was of my upcoming chemo or mastectomy, etc.

So go get checked out. You know who you are. Quit putting it off. Too many people love you.

So Long Joe

2009-10-09T11:03:00.003-04:00

The other day I was up at 5 a.m. A little early for getting my son up at the usual 5:30 to get our school day started, so I walked out to the box to get the morning paper. Usually this trip is one my mother makes in order to get her daily walk in, but I thought I would use the quiet time to at least read the headlines before we had to get the day in gear.

I was reading some story on the front page. I don't even remember what it was about. It was continued on page 7a, the inside of the back page of the first section.

Right where the obits are.

I scanned the page searching for the rest of the story when my eyes locked on a small picture probably 2" tall by 1" wide.

"I know that guy," I said to myself. I just couldn't remember who he was. My eyes flew up to the obit title. It was my best-friend-from-20-years-ago's husband. Karen's husband.

We haven't *hung out* for 20 years since we sort of slowly quit doing things together. Mostly it was my bad choice in men that prevented our friendship from enduring. I married a drunk who took up all my time and isolated me from the world while I tried to *fix* him.

She married Joe, a dream-come-true kind of guy who was everything any woman ever wanted in a man. Hunky, smart, loving, funny, a great cook, a good friend, an awesome host of the greatest keggers known to man... and a lot more I'll never know about.

Karen and Joe. The perfect couple. The ones you just knew would be together until the end of time.

I was looking at his obit and it said he died at the hospital, unexpectedly, at the age of 51.

That's not my idea of the "end of time" as was promised in all the fairy tales.

My jaw dropped and I pictured Karen hugging her pillow, overcome with sorrow and grief.

It broke my heart.

I couldn't call her because I didn't have words to say that could convey how very sorry I am for her.

Last night my sister (who used to work with Karen) went with me to the visitation.

The parking lot was packed with cars, just like the land around their place always was when the bonfire was going by the pond and the BBQ smells wafted across the hot summer nights and the sounds of laughter and pleasant conversation filled the air.

The door to the funeral home was opened by the polite and somber staff, and sounds of Lynyrd Skynyrd drifted across the room. We were led to a guest book to sign our names. I looked up and there, beside the book was an easel with a huge wedding photo of Karen and Joe.

I burst into tears.

I remember that day. It was the most magical day I ever experienced and I had always wished it had been my magic. But it was Karen and Joe's day. Karen was a beautiful angel all dressed in white with flowers ringing her golden hair and Joe was the knight in shining armor, (ok, a white tux) who was there to bring her a new life of joy.

One they both deserved. One they lived to enjoy for 16 more years.

I moved on from the guest book to cross the open doorway that led into the sanctuary where the people were gather in pews and milling about in quiet conversation.

I wasn't ready to go inside.

On the other side of the doorway was a lovingly created display of photographs. All the good times, captured forever on film. Every one of them had Joe's smiling face. Most of them were cheek to cheek with Karen's smiling face.

My sister and I looked up and I saw a face I remembered from 20 years ago but had no name to put with it. I saw lots of people I knew I knew but don't have a clue who they are. Whether it's just age related memory loss or MS stealing my past I guess it makes no difference; I am starting to accept the fact that time is robbing me of my memories.

Anyhow, this person from my past remembered me enough to smile and say "Karen was asking about you and if anyone had heard from you."

This started me crying all over again.

What a lousy friend I've been that I could let anything come between us. She'd always been the best friend a person could ever ask for and I just let this time slide by while I kept telling myself "I really need to call Karen and see how they are doing...it's been so long."

We entered the sanctuary and there on the back wall was a video of photos playing, with Joe's grin smiling over us as if to say "everything's going to be alright". I asked quietly if someone knew where Karen was and they whispered "she's down front wearing the black suit".

I made my way down there and got in line to greet her as everyone offered their condolences. She saw me over the shoulder of someone she was hugging and I could see in her eyes she was surprised and happy to see me. As happy as you can be at a time like that.

I gave her a big hug and cried in her ear, croaking out an "I'm SO sorry!"

What the hell can you say at a time like that??

She put her arm around me and we all walked over to a pew to sit and talk.

I told her just how envious I'd always been of her wonderful marriage and that she had the most wonderful guy in the world.

She tried to tell us the story of what happened, but understandably, she wasn't really able to talk about it.

From what I gathered, their time had been taken up recently with caring for a sick, elderly mother who was being hospitalized. Her's or his, it wasn't quite clear. Next thing Karen knew, she was rushing Joe to the hospital where the doctors came out and said "we're sorry, your husband is dying." And then he was gone.

She said "he new he was sick but he kept it from me."

Not sure what he died of, but that's a heck of a way for your spouse to find out.

I feel so bad for Karen.

But you know, I've speculated that if it was cancer and Joe found out a while ago, it was his right to refuse treatment, or to keep the knowledge to himself.

After all, dying is a very personal and private thing. No matter how close another human being might be to you, they will never know your personal death. They might be there to witness, but death is a solo flight.

Joe chose to keep the inevitable to himself and not dwell on it.

I don't know how long he had known he was sick before he died, but Karen said they had gotten to spend the last 3 years together 24/7 after they had both retired and she will always cherish that time.

Today is the memorial service. A tribute to his life. Afterward there is going to be a big party at the pond. Just like Joe would have thrown. Just like he would have wanted.

And after the party is over, and all the guests have gone back to their lives, I promise I won't forget about Karen.

I promise to be a better friend.

So long Joe, we will ALL miss you!

<3 Jeri

So anyhow...

2009-10-05T13:51:00.003-04:00

I guess I shouldn't leave ya'll hanging in suspense when I announce something like having an MRI that I'm so not looking forward to and then that date comes and goes and not a peep from me.

Maybe it really did cave in and crush me after all, and all those fears were rational?

For all the other MRIaphobes out there, you can relax. I lived through it.

And with 1/2 of one of the two .5mg Xanax pills my trail nurse called into Walgreens for me, I very nearly fell asleep during the whole ordeal. This is the same MRI that I was yelling "get me out of here!" from before the forward movement of sliding me inside was even complete just a week prior. Funny how a drug can alter your perspective so drastically.

Actually, I was pretty anxious before they slid me in this time. The tech said we probably could have let me "soak" another 10 minutes for maximum effect.

I had to do some zen-ish calming deep breathing on the way in, but after I got a little relaxed, it seemed like it was over in no time.

The plan had been to envision the beach and do some astral projection type mental exercise, but the truth of it was that I got in there and started going over all the stuff I needed to do when I got home, and made a mental grocery list, worked out the logistics of some errand runs for maximum gas usage and blah, blah, blah.

Xanax makes me into the average boring housewife, I guess. And I'm not even married.

I got my next 3 months of meds, never heard a peep about the results of that angiolipoma biopsy, and never got pulled from the study. So, no news must be good news.

There seems to be an awful lot of internet chatter lately about Fingolimod/FTY720 and results of the 2nd year of the FREEDOMS study, and it's all good. Something like a 60% reduction in relapses over Avonex?

Quote from the Wallstreet Journal, September 30, 2009:

   By Anita Greil
 Of DOW JONES NEWSWIRES
ZURICH (Dow Jones)--Swiss drugmaker Novartis AG (NVS) said Wednesday a new study showed that patients taking its experimental oral multiple sclerosis drug FTY720 were more likely to go two years without seeing the disease flare up, paving the way for a possible launch as early as next year.

Well, I don't need any stinking WSJ report to tell me THAT! Let's see... I have to go to www.wolfram-alpha.com to find the answer...just a sec.

That's some kinda freaking record for me! In all of my MS-having history of the past decade, I have never had a hiatus like that!

I actually thought my streak was shattered last Friday. I spent the day babying my right leg which felt kinda like I had worn steel wool pants and then got dragged behind the car while holding onto a rope, sitting on the pavement.

But just on the one leg.

My skin felt raw and it was on fire...either that or packed in ice. I couldn't decide since there are only fine nuances that differentiate between the two.

Then, after fretting all day that I would have to call my trial coordinator on Monday, I went to sleep that night and awoke Saturday morning to blah, bland, back to normal. Whew. That was a close one.

I know it's got to happen again eventually, but I'm enjoying my extended stay in the Land of De Nial. As long as I can't feel the symptoms, I can talk myself right out of having MS... and even tho I really DO know I have it, there's no harm in pretending.

As long as I don't forget to take my little magic pill.

Extension Phase 1 year checkup -- part 2

2009-09-15T07:39:00.002-04:00

Yesterday I was supposed to drive back up to Jacksonville to finish up my one year anniversary checkup for the extension phase of the Fingolimod trial. All I had left was the dermatology visit, the eye contrast chart, and the MRI.

Piece of cake, I thought.

I need to quit thinking that because inevitably it's NOT a piece of cake but rather a piece of dog poo I mistook for a piece of cake.

I get in the exam room at the dermatology office, waiting for the doctor in my backwards paper shirt and the pathetic little paper blanket draped over my lap.

He's just supposed to give me a quick once over and double check the scars of my last visit to his office where he decided my cute little beauty spots on my lower back needed to be excised to see if they were something more ominous. They weren't.

He comes in and shakes my hand and starts his exam by looking at the backs of my ears. That's odd, I thought, but didn't say out loud. I guess he's got to start somewhere and since I have a LOT of hair, maybe he thought they might get lost and forgotten all up in there (as they say down here in the south).

Ears; check. Neck, face and shoulders; check. Left arm; check. Right arm...

"So what does the study do if I find something I think needs evaluation?" he asks casually.

"They pay for it because that's why they sent me to you," I say. Why do I open my mouth?

"How long have you had this blue spot on your arm?" he asks as he tried to grab it and pop it like a big pimple or something.

"That thing?" I say, "at least a few years. Longer than I have been in this study, so it's nothing new."

"Does it hurt when I mash it like this?" he asks as he squeezes with all his fingers and thumbs.

"It doesn't normally hurt," I say, "but I can't be certain what you're doing wouldn't be hurting no matter where you did it."

"Sorry."

Ever so casually he says to his assistant, "Get me a blade and a punch kit. We're going to have a look."

"EEEEEK!" was all I could say.

"I should know better to come here! Every time I go away, I leave a piece of me with you." (ala that Paul Young song).

He just laughed and said "What can I say? I like to collect souvenirs."

He buzzed through the rest of the exam and next thing I know I'm getting 3 needles of numbing agent circling my blue spot (more of a subcutaneous lump actually) and draped with a steril cloth with a hole in it.

Since it was the back side of my upper right arm, I had to twist my arm across my torso to allow the good doctor easy access with this Dremel tool kit.

I looked away at first but then noticed a bloody scalpel being handed from doctor to nurse across my body. Time to squeeze the eyes shut tight.

It took about 10 minutes tops to cut me open, gouge out the offending blue lump, and then sew me back up. It actually seemed like a fortnight. (Not really, but hey, how often do you get to use the word "fortnight" in everyday conversation?)

He said something that sounded like "Diagnosis: Antidisestablishmentarianism-oma" to the nurse, not really directing it at me.

I then said "hey, can you write that down so I can show my trial coordinator because I'd hate like heck to get the wrong 'oma' when I tell her."

He obliged me and after scribbling the name of the lump that heretofore had always just been called "Old Blue", he disappeared out the door leaving me to change from the sweaty, rumpled mess my paper clothes had become into my more durable cloth attire.

I looked at the paper and the word was a regular tongue twister. Here I thought "Fingolimod" was a mouthful.

Angiolipoma.

(ăn'jē-ō-lĭ-pō'mə, -lī-)
n. A benign tumor composed chiefly of fat cells and containing an unusually large number of vascular channels.

When he first gouged it out of my arm and held it aloft at the end of his spear (I'm guessing here because my eyes were shut tight), he announced "Yeah, it's nothing to worry about. We'll send it off for path, tho."

I asked the nurse if he was cross stitching his initials into my arm since it seemed to be taking so long to close me up.

So, now I have this huge patch on my arm and I have to wait until the 24 hours are up at 11 a.m. before I can unveil his masterpiece of surgical excellence. I hope I don't pass out. I'm not much of one for movies like Frankenstein, and there's no looking at this trying to convince myself it's only movie magic -- don't be afraid.

And that was only the BEGINNING of my day.

I drove from there all bandaged up like a mummy (ok, well, I had to wear my short sleeve hiked up a little in order to get any sympathetic glances at ALL) and drove over to The Towers as I so affectionately refer to them now.

My trial coordinator was waiting for me and burst into giggles when I told her not to send me there many more times because he's whittling away at me so much I'll eventually disappear.

She had the contrast eye chart for me to do.

Black on white was just fine. Gray on white was a little more troublesome, and the slightly shiny letters on white were gone. She was pointing at the chart with her pointer and I was saying "there's nothing there."

After fiddling with the position of the chart and the blinds on the windows to alter the ambient light, we tried again.

This time I did better, but still a dramatic change from last time. Had it not been for the fact that this was the new deviation from the standard practice of the actual eye doctor performing the test in her office, I may have worked myself into a panic thinking I was going blind (even tho I could see just fine).

But since the eye doc is such a busy lady, my trial coordinator thought she'd help out by doing the eye contrast tests in her office instead.

So much for the constants in the science experiment that has become my life. I asked her to please mention to Novartis that we aren't conducting the test in the normal place and the lighting is different so they don't boot me from the trial and give me a candy striped cane as a parting gift.

After that was over, the only thing left was the MRI. I was scheduled to be on the same machine as always since the start of the trial so I knew it was the 4 foot tube and that it's no big deal.

At least it wasn't any big deal last year when I shot the tube with no drugs to calm me. I recall I was so relaxed I nearly fell asleep.

I guess yesterday was an exceptional day. I got in there and laid down on the table to get ready to slide into the tube and I just started hyperventilating.

It didn't help that the technician was trying to calm me by telling me all the stuff that was NOT going to happen to me. Stuff I may not even have been worried about was now thrust as actual scenarios into my conscious thought...

"Don't worry...it's not like it can crush you or anything."
"And there's plenty of air in there, you won't suffocate."

Did she really wonder why I mashed that panic button as soon as she left the room before the MRI was even out of neutral??

I had a washcloth over my eyes, headphones closing me off from the world and gripping my head, and a bird cage slid over my face. Then I was shoved into a paper towel tube and a muffled voice was saying "you're doing fine! just relax...nothing bad will happen, I promise."

BZZZZZZZZZZZZZZZZZZZZZZ!

"You want to get out?"

"yep."

"Ok, that's fine. Tell your trial nurse you need some meds to do this and we'll reschedule."

"Ok, I'm so sorry. I didn't mean to waste your time. I just can't do it. The stress of having my arm gouged out unexpectedly a couple hours ago must be why my lunch wants to come back up."

So I went back to my trial coordinator who looked at me with a puzzled "how can you be in the MRI machine right now AND be standing before me?" look.

"I couldn't do it. I gotta have some Xanax, sorry."

"That's ok.... but..."

"What?"

"Well, didn't you do it last year on the same machine without any drugs?"

"What can I say? I'm perfecting my hypochodria in my old age," I shrug.

So now I have another MRI scheduled for the day I have to come back up to get my Frankenstitches out.

Stay tuned for Extension Phase 1 year checkup -- part 3, or

The never ending clinical trial checkup.

I go back on the 24th.

One Year Anniversary of the Extension Phase in Fingolimod Trial

2009-09-05T19:28:00.002-04:00

It came and went. The two year mark of being in this clinical trial (including the past year that was the extension phase) happened on August 20th.

It came and went without so much as a "hey, today is the day!" comment. And what is so amazing about that is it went by because I was having a BORING normal day. No MS drama, no steroids, no hospitals, no canes, walkers or wheelchairs (although I own them all, just in case).

It was a Thursday and I was enjoying sitting around with my mom and sister for our usual Thursday night get together where we watch Big Brother or Survivor... whatever is in season.

But it is a monumental day in my life that should not go unrecognized. It marks the two year anniversary of the best decision I have ever made in my life. To join this clinical trial has literally given me my life back.

When I look back at where I was two years ago, I realize with some alarm how close I was to cashing in my chips, buying the farm, kicking the bucket, pulling the plug, punching my ticket... whatever you want to call it, I was at the end. I was looking at my future with MS, that drama queen that would steal the show and alter all lives in it's path, even if only for a few weeks at a time, and I just didn't want to do it any more.

I remember reading over the informed consent and weighing my options. "Either I take a chance with this stuff and perhaps die, or just stick with what I have known for several years and want to die."

The choice made itself. And I have not had a single documented MS relapse since starting.

With all the stress, heat and exertion of moving and trying to get the house up to snuff for the insurance company this past month, I know if I hadn't been in this trial and taking my pink power potion, there is NO earthly way I could even have imagined doing all that I have done without having to have a nap from the sheer exhaustion brought on by such an idea.

When I went to my 1 Year Anniversary of the Extension Phase Checkup, the lady neurologist who performed my EDSS test said (and I quote) "I really can't find much wrong with you. You really seem pretty normal to me."

To which I replied "My kids would beg to differ."

I took that other test where they play the recording of the guy saying numbers and you have to add the first 2 together and say the total, while remembering the last one he said and adding it to the next one he's going to say (if it sounds confusing, try having to actually DO it! A new number ever 5 seconds.)

I always get a perfect score on the practice round, get cocky and tell them "I don't need no more steenk-eeng practice rounds!" and then majorly flub the real McCoy.

But this time I ACED IT!! No fooling! I was surprised as you are. Well, probably more because you had to be there for the drama of it and all. The lady giving the test couldn't believe it either.

I also did the peg test, had an EKG, walked the hall 25 times (in 12 minutes) for 500 meters, had a PFT, gave about 6 vials of blood, and peed in a cup. Oh, and I had my eye exam.

Everything was just fine.

I go back on the 14th for my MRI and dermatology visit. Hoping everything is "fine" then too. Being a hypochondriac it would go against my very being not to worry that something was terribly amiss. So, that's what I'll worry about between now and then.

My next real worry is: what am I going to do when this stuff gets approved?? I won't be able to afford it. It sucks to think I might not be able to afford to pay for having even a normal, boring, mundane life. I'm not asking for a million bucks or to be able to travel the world or even a $100 Wal-mart shopping spree. I just want to live a life where my biggest worry is how to pay the electric this month. And not have to worry about "am I going to be able to walk this week?"

Novartis, if you're listening, the humane thing to do for all those of us who are so bravely offering up our very lives in order to further the advancement of this magic Fingolimod pill so that you may reap obscene profits from the suffering of hundreds of thousands of people with MS would be to at least give those of us who allowed you to poke and prod us in the name of Science free meds for life. Would that really be such a dip into the billions you are projected to make off this pill?

And you know I've been plugging this stuff for a couple years now for you. What better hype could you get than word of mouth?? You can't BUY that kind of advertising... but I'd never turn my nose up at free meds for life. Come on, have a heart. I'd be sure to blab all about it and you'd look like a bunch of humanitarians on top of delivering a pill to all those poor MSers sick of sticking themselves.

It's a win-win, don'tcha think?? :D

I'm Baaaaaaack!

2009-09-05T07:21:00.003-04:00

Did you miss me?

Sorry for the long hiatus but it wasn't because I was stranded on some luxurious island sipping exotic drinks while laying in my hammock feeling the breeze and listening to the lapping waters.

No, I have been preparing to move and then actually doing it.

The reason I mention the "preparing" part is because that is what really took the longest. I've been in the same house for 20 years and I'll go ahead and confess now that I was a hoarder. I think it came from the fact that we had a devastating flood when I was a child (1972 hurricane Agnes caused the Genesee River in Wellsville, NY to fill up our first floor of our home). We lost darn near everything.

After that I just held onto everything. Well, it's either that or I was just too lazy to go through stuff and kept "saving it for later just in case".

At any rate, I had lived in this house for longer than I ever lived anywhere and so the "save for later" stuff had pretty much been allowed to take over my back room.

So I have been freed from my obsession through a couple weeks of sorting and a bunch of trips to Stinky Town (the dump) with trailer loads of stuff I no longer felt compelled to drag around with me through life.

I'm telling you, it's a liberating feeling to be leaning more towards a "zen" kind of minimalistic existence.

When you have to move all that crap it really brings its worth to the forefront. I had some stuff that I was really attached to go rolling down the hill at the dump and I didn't even shed a tear.

I didn't do a yard sale, ebay or even craigslist because there wasn't any time and it would have meant holding onto stuff longer and possibly having second thoughts. There wasn't even any lucky helper to root through stuff and say "You're really getting rid of this?? Can I have it??"

Well, my oldest son did help me (he, in fact, did most of the lifting/hauling) but he didn't get overjoyed or envious of any of the junk I was throwing away with the exception of a box of wires that could be used to connect various electronic components.

Right in the middle of our move, a guy came by from the insurance company to take pictures and report back to our new home owner's insurance company.

We got a subsequent letter stating we were canceled.

The reasons being:

The bushes were too big (my 50 year old azaleas).
The house was green and needed pressure washing.
The yard needed to be mowed.
Branches from the tree out back hang over the roof.
The steps needed handrails on both sides.
The laundry room steps needed handrails (even tho nobody has ever used that door in the last 20 years.)
The trampoline was still up (I had told them it would be disassembled but I hadn't gotten that far yet).
The project Jaguar in the back yard (inside the privacy fence) was listed as a "junk vehicle" that needed to be removed.
There was "trash" all over the yard. (the stuff I was sorting and taking to the dump, along with all the construction materials I was saving from our remodeling efforts from the past 2 years).

So, while I was trying to go through all my "stuff" to pack and move, etc., I also now had to contend with a deadline to get the house in shape by Sept. 4th so I could find a new insurance company who would write a policy based on my "rebuttal" photos.

So, one day would be spent making trips to the dump, or filling up boxes with the "keep" stuff, and other days would be spent pressure washing the house, painting the porch, building handrails etc.

If it weren't for the help of my son, and John and his carpenter friend and motivational force Larry, I'd have never made it.

We:

Hacked the azaleas down to the ground so they couldn't argue that they were still too big or possibly touching the house (they are stumps now).
Pressure washed the whole place with Larry's industrial sized pressure washer (I did very nearly all of that chore myself).
Hired a guy with a riding mower to do front and back yards.
Used Larry's pole saw to trim trees that hung over the house.
Had Larry build handrails for front porch.
Had him build a pair for the laundry room steps.
Took apart the trampoline.
Put the hood back on the Jag and covered it with a car cover.
The "trash" pretty much took care of itself once we had the stuff sorted and packed or hauled to the dump.

Whew.

Yesterday was the deadline and I emailed all the pics to our insurance company. They still want a few more pics, but they sent me a quote from another provider. Hopefully that will all be a bad memory real soon and everything will be back to normal and fully insured.

It's almost like they wanted a brand freaking new house to insure. The place was built in the 40's for crying out loud.

So, now the other part of the story.

We moved because a) we are struggling to pay the mortgage since John works construction and is out of work much of the time lately and b) my son and his wife and daughter (who live with my mother) wanted their own place and were going to move out and leave her living alone.

I couldn't have that. So, John and I talked it over and decided the logical solution would be for our family to move in and stay with her while my older son's family moved into our house and paid the mortgage. Problem solved.

The move is nearly complete but each party still has "stuff" at the other party's former home.

And none of this would have been possible without my Fingolimod. I think it gives me super human strength, or at least it kept me from collapsing into one big puddle.

All this, and I had my 2 year study checkup last week, but that's another post.

2009-07-16T07:18:00.004-04:00

An excerpt from an article on Novartis' performance in the first half of 2009. :

FTY720 (fingolimod), a novel oral development therapy for multiple
sclerosis, showed continued low relapse rates after four years in
patients with relapsing-remitting MS in an open-label Phase II
extension study. The data, presented at the American Academy of
Neurology (AAN) meeting in April, also showed no significant change
in the safety profile from three to four years. Data at AAN from
TRANSFORMS, a one-year Phase III trial against interferon beta-1a
(Avonex®), showed 80-83% of MS patients given FTY720 were
relapse-free for one year compared to 69% of patients treated with
Avonex® (p<0.001), with a safety profile for FTY720 in line with
previous experience. US and European regulatory submissions are
expected by the end of 2009. Initial results of the Phase III
placebo-controlled FREEDOMS trials are also expected in the fourth
quarter of 2009.

So, it still sounds like it's set for submission later this year, but then who knows how long the approval process will take assuming it will even get FDA approval?

Small wonders

2009-07-04T16:42:00.003-04:00

Drat the fact that my camera has dead batteries. I would love to show you what I discovered in my back yard.

I have been lamenting ever since the start of summer that I live on a major road that goes through my small town and we don't have a lawn mower or money to buy one or to pay anyone to cut the grass for us.

Because of this, I have tried to time it so that I am only seen outside after dark so I don't have to see the stares of passersby who gawk at the incredible height of my grass which has now V'd off at the top and gone to seed in all its splendid glory.

I try to spend most of my time behind the privacy fence I once attempted unsuccessfully to scale and ended up hanging by my bra from at rush hour for all to see. That way I have my ... privacy ... with my backyard jungle where the waist-high weeds don't bother me nearly as much.

But, as John so often tells me when his eyes glaze over while listening to one of my stories, I guess I need to GET TO THE POINT!

Well, ok, the point is that the other day I decided the only way this last 10lbs is going to leave my body is if I do something proactive like, I don't know, walking. I decided to walk the inner edge of the privacy fence and maybe the tall grass would actually be beneficial by providing some resistance and making me burn more calories.

I have to be careful where I walk. There are pine cones and dead tree branches hiding in the tall grass waiting to trip me up. So I look down.

Funny thing about that. Looking from my back porch around the yard all I can see are flourishing weeds and tall grass that makes me feel ashamed and embarrassed. But when I waded out in it and began making the circuit around the yard, I found so many hidden treasures that mowing would have never allowed to happen.

All the weeds were in full bloom. There are white flowers, yellow flowers, purple flowers and blue flowers all over my back yard that I never knew were there. After making only one revolution of the yard, I had to go inside and get my 10 year old son to come out and join me for the hunt for the elusive flowers.

Some were flat and oval, some were on stalks that bloomed all the way up the stem. Some were little puff ball shaped things. Some were shaped like bells.

It was incredible. It was beautiful. And I never knew it was out there in my back yard.

And it never would have been if I had a lawn mower or could afford to pay someone to cut the grass.

So, once again I am humbly reminded that there are silver linings to everything and many different ways to view any situation.

I was choosing to be embarrassed and stress over the tall grass. Until my eyes were opened to the beauty cradled beneath.

Don't get me wrong... I still wait until after dark to check the mail.

And I would have run out to buy batteries and capture the beauty to share with you, but as I write this John has gone out and fired up the weed eater and decided to tackle the back yard manned only with that insufficient tool.

Our back yard alone has to be nearly a half acre. And he's gallantly swiping back and forth. Vanquishing the tall green foe.

Obliterating the small wonders within.

I wish he would have done the front yard, but no dice. He says he'd rather have tall grass than have anyone who knows him drive by and catch him trying to weed eat the entire thing.

Oh well, it's like my dad said when he built his house and didn't spend much time on it's outer beauty but made the inside look like something out of Better Homes and Gardens... "I'm not spending my time making it look good for the neighbors - I want it to look good for us."

So the back yard is looking pretty good -- even if the neighbors will never know.

Newly discovered brain cell could be key to MS therapies

2009-06-30T10:46:00.002-04:00

The article below was passed to me by a dear friend and it sounds both promising and exciting! Read on...

Newly Discovered Brain Cell Could be Key to Multiple Sclerosis Therapies

Institute researchers have identified a type of cell within the human brain that may be a previously unknown precursor to the stem cells that are capable of promoting growth of new neurons. The discovery could lead to new therapies for neurodegenerative diseases such as multiple sclerosis.

Bruce D. Trapp, PhD, Chair of the Institute's Department of Neurosciences and a leading multiple sclerosis researcher, said the cells called beta 4 tubulin (betaT4) are scattered throughout a region of the brain called the subventricular zone. This zone is known to be a source of stem cells capable of regenerating neurons. It is within the cerebrum, the part of the human brain responsible for social interaction, learning, memory, speech and language, and motor functions.

“Strategies for cell replacement to treat neurodegenerative diseases are very attractive and offer therapeutic possibilities. One example is generating the cells needed to replace the myelin that surrounds, protects and nourishes the neurons in the central nervous system. It's the loss of this myelin that causes lesions in multiple sclerosis [MS] brains,” Dr. Trapp said.

Oligodendrocyte progenitor cells (OPCs) generate new oligodendrocytes, which are required to produce myelin. “Unfortunately, OPC growth is limited, so MS lesions often don't remyelinate. Stimulating other types of precursor cells shows great potential in promoting oligodendrocyte production and remyelination in MS patients,” Dr. Trapp said.

Dr. Trapp's research points to betaT4 cells as one of the precursor cells needed for remyelination.

The presence of betaT4 cells in the subventricular zone peaks during the later stages of fetal brain development, but decreases shortly after birth – suggesting the cells' role in forming neurons. Researchers also found that the number of betaT4 cells significantly increases in the subventricular zone that borders MS lesions in the white matter of brains.

“In our research, we observed that the myelin generated by a relatively small number of transplanted betaT4 cells exceeded that of another known progenitor cell,” Dr. Trapp said. “It's still not clear if betaT4 cells are true stem cells or primitive precursors to stem cells, and the potential of stem cell therapeutics to treat neurodegenerative disease requires additional studies of stem cells in human brains.

“But we propose that betaT4 cells represent a cellular source for the latter stages of myelination and neural repair in the central nervous system” he said. “They could be a promising new direction for cell replacement therapies for neurodegenerative disease.”

Dr. Trapp's collaborators include Chuanshen Wu, PhD, Ansi Chang, MD, Maria C. Smith, Roy Won, Xinghua Yin, MD, Susan M. Staugaitis, MD, PhD, and Grahame Kidd, PhD, of the Institute's Department of Neurosciences; Dimitri Agamanolis, MD, of the Department of Pathology at Akron Children's Hospital; and Robert H. Miller, PhD, of the Department of Neurosciences at Case Western Reserve University School of Medicine. The findings appeared in the Journal of Neuroscience ( www.jneurosci.org/ June 16, 2009). The research was supported by grants from the National Institutes of Health's National Institute of Neurological Disorders and Stroke and the National Multiple Sclerosis Society.

Source Article

RIP Billy Mays

2009-06-30T10:43:00.002-04:00

He missed his calling and should have been a comedian. I'd have liked to have seen more of him than just the 2 minutes of yelling at me to buy something.

Loved watching "Pitchmen".

Infomercials just won't ever be the same again.

My next move...

2009-06-29T19:25:00.003-04:00

Inspired by all the videos floating around out there as a result of Michael Jackson's untimely death, I have decided this is the next thing I'm going to try to accomplish.

I want to go for my visit to the clinical trial checkup and have the neuro performing the EDSS test ask me to walk for him. I just want to see the look on his face when I pull off the Moon Walk.

I'll probably lose points off the mental stability part of the test (with copious notes accompanying the test outlining my Wacko Jacko impersonation). Heck, they may even admit me for further evaluation, or maybe even halt the clinical trial because of this heretofore unknown side effect.

I just want to see their faces.

And between tests, when I have to walk from one office to another... I'm going to say it's the only way I can now walk. BWAHAHAHA!

I'll be lucky if I can do it at all. So far, in preliminary practice sessions in my hardwood floored hallway and stockinged feet, I have been unsuccessful at recreating this move in a smooth, flowing fashion.

First off, I have to put my hands on either wall to my sides in order to maintain my balance in the starting position, which ends up more reminiscent of Daniel about to pull of the Crane kick in Karate Kid.

Maybe I should just practice that. Then when the doc goes to wack me on the knee with his rubber mallet, I can say it was just my hyper reflexes. Not my fault.

I don't know what is driving me to conquer moonwalking at this time in my life when I couldn't do it back in the 80's.

Maybe I do have some mental deficit.

Or maybe I should just get a life. :-)

My own personal update in the FTY720 TRANSFORMS clinical trial

2009-06-24T20:35:00.003-04:00

I just posted about the newest findings that kick butt about FingoHeads from the Phase II trial being still relapse free after FOUR YEARS (standing ovation for them, please) but I thought I should throw in my own two cents about my experience thus far.

I started in August 07 so that means I have been in this clinical trial for

this long (according to www.wolframalpha.com )

During this time I have never officially had a relapse, although I have informed my trial nurse at least 2 times that I remember that I thought I might possibly be having one.

And lately I have been having not so much of a relapse, but just a recurrence of oldies but goodies. For instance, my legs are doing that fire and ice thing again where my calves feel like they are burning or really cold. The other night they cramped up really badly, too. I remember both of these symptoms from the very last bona fide relapse I did have -- the one from April of 07. It was much more pronounced back then. After having just a taste of it lately I wonder how I made it through life back then where I was in a constant state of misery.

These latest symptoms are only cropping up lately because I'm trying to do too much, or getting myself stressed out, or not getting enough sleep, or a combination of all of them.

They really started right around the time my son was going to graduate from elementary school and I realized he's growing up despite my efforts to keep him forever young so that I, too, shall be. With all the end of year parties, and then the HSV attack which led me to the GYN only to find out I need that ultrasound of the ovarian cyst and getting reprimanded about ovarian cancer, and then over working myself, etc. etc.

Well, these symptoms are like some sort of divining rod or something. When I have all the right circumstances, my legs start to burn and I get that buzzing down my spine and everything starts cramping up. All as if to tell me, "hey now! Take it easy!!" I don't find water, but I do find my body needing rest.

Once I've had a good night's sleep in my recliner (I've been sleeping there for 2 years now [possible Fingolimod side effect alert!!] and, try as I might to go back to a real bed, I just can't do it) I feel all better.

When I tell the trial people about these "almost" relapses, I am asked to grade them on a scale of 1-10 as far as severity goes. It's always been a 1, or 2 at the most, so they end up conveniently forgetting that I called. Nobody ever really checks it out to follow up with poking/prodding/testing to verify whether or not there is disease activity.

So, while the news I posted in my last blog entry is GREAT, I just wonder how many of us have actually had some form of a relapse that went unnoticed.

I still proudly say that I am relapse free after more than 2 years (since April 07) but sometimes I wonder if that's really the case...

Or maybe I'm just being true to my hypochondriacal self?

Only my hairdresser knows for sure. (for your younger people, that's a Clairol commercial from the 70s I think).

I'll have to ask her next time I see her.

Oral Fingolimod Lowers Disease Activity in Patients With MS for Up to 4 Years

2009-06-24T20:31:00.002-04:00

Just got this in my alert email today and wanted to share. My favorite part is in green.

Oral Fingolimod Lowers Disease Activity in Patients With MS for Up to 4 Years: Presented at ENS

By Judith Moser, MD

MILAN, Italy -- June 23, 2009 -- Patients with multiple sclerosis (MS) show sustained clinical benefit when treated with the novel sphingosine-1-phosphatase receptor modulator fingolimod (FTY720), according to the extension phase of a multicentre study presented here at the 19th Meeting of the European Neurological Society (ENS).

Ludwig Kappos, MD, Clinic of Neurology, University Hospital Basel, Basel, Switzerland, presented the 4-year follow-up findings of a phase 2 proof-of-concept study investigating oral fingolimod in the treatment of MS here on June 22.

Fingolimod targets MS via the immune system and probably via the central nervous system as well. "The main mode of action pertains to a redistribution of lymphocytes, which normally stay protected in lymph nodes," Dr. Kappos explained.

The core study, which covered the time between baseline and 6 months, compared once-daily fingolimod 1.25 and 5.00 mg with placebo. In the randomised, dose-blind extension study (months 7-48), patients formerly on placebo were rerandomised to once-daily oral fingolimod 1.25 or 5.00 mg so that all patients were on active treatment.

As Dr. Kappos noted, the number of circulating lymphocytes was permanently reduced in all dose groups by approximately 70% throughout the extension period.

Similarly, the number of gadolinium-enhancing lesions remained low in all arms over 48 months. More than 95% of the study population were free of gadolinium-enhancing lesions at the end of the 4-year extension period.

These findings translated into a low annualised relapse rate. Most patients (51%-70%) remained relapse-free for up to 48 months. Furthermore, most patients were free from disability progression at the end of the study.

"Fingolimod was well tolerated," Dr. Kappos reported. "The long-term safety profile was in line with previous findings."

In the group with the highest cumulative dose, a tendency toward higher infection and nasopharyngitis rates was seen. However, serious adverse events were equally distributed between the dose groups.

Blood pressure and pulmonary function measurements remained stable during the extension study. Asymptomatic elevations of liver enzymes were observed in 16% of patients without any evidence of serious drug-induced liver injury.

Seven cases of localised skin cancers, which were detected by regular examination, occurred within the first 36 months. Between months 37 and 48, no new cases were seen. "This indicates a lack of cumulative risk with increasing drug exposure," Dr. Kappos said.

A phase 3 study program is further characterising the efficacy, safety, and tolerability of oral fingolimod in patients with MS.

Funding for this study was provided by Novartis Pharma.

[Presentation title: Majority of Patients With Relapsing Multiple Sclerosis Receiving Oral Fingolimod (FTY720, a Sphingosine-1-Phosphatase Receptor Modulator) Remain Free From Any Inflammatory Activity: Results of a 4-Yr, Phase II Extension. Abstract O21]

Source: http://www.docguide.com/news/content.nsf/news/852571020057CCF6852575DE00716D8A

If you don't have insurance, just don't get sick. Simple.

2009-06-11T15:03:00.002-04:00

I'm so sick of this crap. I've been dealing with it (like a LOT of other American's) for years now. A diagnosis of MS that keeps me from being able to get health insurance, thus effectively cutting me off at the knees when it comes to health care.

I just got a call from the imaging center saying that the idea of billing Novartis for the ultrasound I need of my left ovary is "too third party" for them. I can't have it done.

Great. There is a machine in that building and a person who gets paid by the hour to operate it, that is just so close I can smell that stupid gel they smear you with, BUT I can't get it done so I get to just GUESS if I have an ovary-bomb waiting to kill me.

Or, I can pay thru the nose. Money I don't have that I am trying to scrape up to keep from losing my home (a whole different ball of stressful worry wax).

Funny that Novartis' check was good for them last year when they did the first ultrasound that discovered the cyst. You get one new person in the mix and they have no problem telling you NO.

How can one human being sit there and not break down into tears having to tell another that a possibly life-saving procedure that could change the whole direction of the remainder of the other person's life is going to be denied them because they don't have enough pictures of dead presidents hanging around???

This is freaking absurd and God is looking down on us ready to throw up because it makes him so sick to see what we have become as a society. Maybe he should. Maybe it should be a big plague of puke raining down on us all, clogging all the precious machines that only the wealthy are privileged enough to be treated with. Clogging everything and sickening everyone. What would the insurance gods do then?? Go hide under a big red umbrella? I think not.

And they would be running around screaming in fear as the puke slowly killed them. And the rest, like me, would be calmly standing by welcoming them to our world.

there. I feel better.

Maybe I can get someone to loan me the money.

And then I better just pray it turns out to be nothing because if just DIAGNOSING ovarian cancer can be so elusively hard for the uninsured to accomplish, treating it will take an act of... well, God.

On a scale from 1 to 10, or, the EDSS

2009-06-11T12:38:00.003-04:00

Today was visit number 17. It was to be a short checkup (after the long, gas-guzzling drive there)to include blood draw, vitals, and the Expanded Disability Status Scale test.

This test, as I've blogged about before is performed by a neurologist and it's the neurological equivalent of the 20 Questions game, but instead of "Is it bigger than a bread box?" you get questions like "Do you have hesitancy/urgency when urinating?". I always want to ask them something equally embarrassing in return and see how they like it...

"Do you have to sit like a girly-man when you pee?"

Anyhow, today's test was performed by a doctor whom I have seen before for the same test. He recalled my answer the last time he asked the standard question "Do you experience any sexual dysfunction?" and my reply was "Does not having any sex count as a dysfunction? No? Then I don't know if I'm sexually dysfunctional."

He had a good laugh over that (again) today, with the young guy accompanying him (remember it's a teaching hospital and I was the live specimen today).

The test went as it usually does, with notes being made that my left side was more outta wack (that's a medical term) than my right, which seemed in perfect wack.

At the end of the test I got 3 pleasant surprises.

1) When I asked what, theoretically, would happen if I couldn't finish the 500 meter walk, the doctor replied "What? Are you tired today and don't feel like it? Because it won't count toward your score if you don't want to walk."

So naturally, being of sound mind, I stated that I didn't feel like it. Thinking back now, that could have been a test of my mental acuity in that nobody in their RIGHT MIND would choose walking a long-ass hall 25 times over opting to take a pass. Therefore, I am in my right mind today. whew!

And the other pleasant surprises, you ask?

2) I got to listen to the neuro who performed the test explain to his student how to grade an EDSS test.... and I HEARD MY SCORE!! I have never before had an EDSS test and known what the results were because of all the hush-hush "we can't let #8 know anything about her trial stuff" kinda treatment.

I scored a 1.5. on a test where 0 is perfect and 10 is dead. The only thing they ever told me before was that I was closer to 0 than 10. Well, duh. I could have figured that out on my own.

and last but not least, the most pleasant of all surprises....

3) My extension phase is NOT one year as I could have SWORN I was told to begin with... it's 2 years! YIPPEE!! Guaranteed drugs for at least another year and 3 months. Whew. A Fingohead's worst nightmare -- to be denied her FTY720 -- avoided for another 365 days, or 12 months or 52 weeks but who's counting?

The rest of the visit was just getting my new pills and trying to work out the details of Novartis being cajoled into paying for my recent GYN visit due to an HSV outbreak and the need to be seen as my trial coordinator insisted. Seems if they insist, they should pay, right??

Well, the GYN visit collapsed from being about HSV into a scathing lectured (once the doc reviewed the notes from my last visit) about how I never got a follow up ultrasound regarding that cyst on my ovary.

He launched into a tirade about how there are no perfect tests for ovarian cancer and that I needed to stay on top of this. When he said "three months" it did not mean "or in a year, whichever you prefer".

So now here I am waiting to see if the drug company will pay for a follow up ultrasound of my ovary, which, if I self-paid would cost me $231 (might as well add a string of "0's" after that for either way I can't afford it).

I don't have the desire or mental strength to spend time worrying about the possibility that I have ovarian cancer. I just can muster the horror. Does that mean I'm slacking as a hypochondriac? No, whew, I was worried there for a minute, but any hypochondriac that can actually worry that they are somehow not performing correctly as said hypochondriac, well, they have nothing to worry about. How ironic.

I'll try to blog more when I have something profound to say. I've been waiting for profound thoughts and that's why it's been so quiet here. Maybe I should just stick to posting profound thoughts on Twitter since it is less strain on the brain to come up with profoundness in 140 characters or less.

Hope ya'll are staying relapse free or able to fake your way through. It's too beautiful out today... as my father would say "I think I'll leave it out."

Time once again for the Blue Crab Festival or What was I thinking?

2009-05-24T14:27:00.001-04:00

Last year found me venturing out to the Blue Crab Festival for the first time since my diagnosis in '99. Fingolimod had given me back so much of my life that I dared to walk where I hadn't walked in years: the streets of downtown Palatka, FL during one of their many street-clogging, traffic-halting "festivals".

This year was not going to find me sweating and gimping around cursing myself and wishing I had never left the comfort of my air conditioned home with comfy chairs ever 10 feet. No sir! I had learned that I COULD scale Mt. Blue Crab Festival and live to tell the tale... those who climb Everest don't do it as a once a year family vacation. They do it, they got the T-shirt, and they move on.

I was going to move on.... over from the computer to the couch and see what was on satellite.

Until I got the call from my sister.

"Did you want to take the kids to the Blue Crab Festival and check out the Seafood Cookoff?"

Knee jerk reaction would be to say "NOOOOOO!!!" Not only was I happy not to drive there, find a place to park within a day's hike to the activities, walk all over in the heat and humidity until I couldn't feel my legs and my knees wanted to buckle... I didn't want to also spend my life savings on letting the kids gamble with their lives aboard the rickety-looking carnival rides operated by folks with names like "Cletus" who were sporting a whole set of 3 teeth in their heads.

But there was something intriguing, magical, beckoning, about the words "Seafood Cookoff". Maybe it had to do with the fact that since I gave up cigarettes I have doubled down on my food fascination, or maybe it was the fact that I had yet to eat breakfast that day, but I caved.

Within hours we were instructing the kids on how much of a rip-off the rides were and how much more enjoyment they would get out of a funnel cake as we were on our way (blue parking plackard in hand) to go the the Blue Crab Festival Seafood Cookoff.

We parked at the Holiday Inn, which was across the 4-lane highway from the festival. As we pulled into the parking lot we saw 3 dirt-bag looking people with a hand made sign stuck in the ground that said "Parking $5". They were sitting on those plastic patio chairs you can get from Big Lots for $5 each and they just didn't have any "officalness" about them. We handed them $5 as my sister passed on the joke that we thought they were just sitting there taking $5 because it seemed like a good scam. I still don't know if Holiday Inn had a clue they were selling their parking spaces.

We had the bright idea that we should walk the boardwalk that goes parallel to the bridge, out over the water, and then crosses under the bridge and back parallel to the other side of the street. This way we would avoid all the traffic as there was no light to cross at right there by the foot of the bridge.

We won't do that again.

Northeast Florida has just had 8 straight days of torrential downpours and this day (Saturday, May 23, 2009) looked to hold no promise of any glimpse of sunshine, altho the rains had temporarily ceased.

The walkway was wooden and the cupped boards were puddled with water. This was fine until we entered the underworld side of Beneath The Bridge where bird crap, bat droppings, mold, and mildew rule the domain. Suddenly the puddles became slip-n-slide death trap land mines to be avoided at all cost.

At one point my sister grabbed the handrail to avoid catastrophy. Big mistake. She shook hands with a great big spiderweb instead. Ewwww!!

By the time we had walked first out over the water, then under the bridge of trolls, and back to dry land, we had walked about 10 times the crow flying distance between the car and the tent with the Seafood Cookoff. Ah well, live and learn. Or, live and forget and be condemned to think that street-crossing strategy is a good idea next year.

We made it to the tent where the Seafood Cookoff was underway but not before hunting down a funnel cake. Seems my son was more interested in cartoons than breakfast, so (once you take away electronic forms of stimulation) he was suddenly starving to death.

Hard to believe a fried lump of drizzled batter much akin to the mess I sometimes make creating pancakes can actually fetch $5. Same thing with the lemon, chopped in half and tossed into a cup (no larger than I'm given for urine samples) along with a little hose water and sugar. They dub it Lemonade and get $5.

We spent $15 on one funnel cake and 2 lemonades before we ever made it to the Seafood Cookoff tent.

Once seated at a plywood table we tore into the funnel cake from 4 competing sides and devoured the poor thing before you could say "drawn and quartered".

We saw a few people we knew, but mostly strangers who came up with their kids and said "my kid knows your kid from school and wanted to say 'hi'."

There's nothing more disconcerting than taking a 6-year-old granddaughter and a 10-year-old son someplace out in public only to discover they have more of a social life than you do.

Then came the judging. I don't remember who won what for which entry, but I do remember that Mary Conner who got 3rd place for her chowder gets my vote for best tasting seafood concoction I ever ate. Yum! I don't even CARE that I didn't get to sample 1st or 2nd place stuff. Her's was downright heavenly.

After we tossed our sample cups we debated the long avenue stretched out ahead of us. What appeared to be hundred of blocks (in reality only about 10 maybe) lined on either side with booths of arts and crafts, downright junk, and the wild and weird.

Dammit. I was tired of giving in to my old body and tired legs every year. It's gotten to where if you ask one of the kids in the family to do something, they complain "I don't want to...my legs are tired!" Knowing where they got that saying made me want to fight thru the pain that much more.

"Let's see what's up that way," I said to my sister. She was taken aback (I always wanted to say that) and had a look of awe and wonderment on her face.

"You really want to??" she said in that "I'm not so sure about your current state of mind" kind of tone.

"Yeah, I think so."

And with that we each took the hand of one of the kids and started wandering with the ebb and flow of humanity in the general direction of Up the Street and (more critically) Away from the Car.

There were leather belts and caps with names stamped on them, there were cloggers dancing in the street, there was a guy with an automatic bubble blower, there were food vendors and hand-made everything....

I came to stop (more out of physical necessity than interest) at a booth where the vendors were selling their hand made pottery. The longer I looked, the more beautiful the pieces became. I started looking at the price tags (something I never bother to do at these places since I have no intention of spending money).

And then I spied the basket.

There was a woven basket with these small disk shapes of pottery, all ruffled on their edges and stamped with various designs in the center -- all beach themed. I read the sign -- "Spoon rests - $4 ea. or 3/$10".

That's all it took. I've been meaning to buy a spoon rest and what nicer one could I ask for? A trophy of sorts that, in future years, I can look and and think "I walked a LOT that day!" and hopefully that memory will make me smile.

I picked out one for me, one for Mom and let my sister pick her own.

We forged ahead.

After several minutes of seeing stupid T-shirts for sale and dog toys, and handmade wooden furniture... I suddenly realized my legs were screaming "UNCLE!".

"You want to go back now?" my sister asked, as she noticed I was no longer moving forward but rather standing still staring glassy-eyed at the endless corridor of booths ahead of us.

"I'm done walking," I said. Trouble was, I wish I would have known halfway to that point that THAT was all the walking I wanted to do. That way I could give out exactly as we made it back to the car.

My rubber chicken legs managed to carry me (without too many antics) back to the car via crossing the street down by the light. No more scary pigeon poop, spiderweb, and god-knows-what covered walkways beneath bridges. We leave that to the trolls.

As we were strapping on our seatbelts, my granddaughter said "Look! Just in time!"

We all looked up to see the black cloud in the sky split open and pour it's guts out on the Blue Crab Festival.

As we drove away, my sister and I reminded each other that no matter what we might think NEXT year, we really DON'T want to do this again.

Too many spoons used, not enough return. (if you don't know the spoons theory, you can read about it by clicking here).

If I could have walked another 10 feet or so, I probably could have gotten that guy in the T-shirt booth to make me one that said "I survived another stupid festival and all I got was this overpriced T-shirt".

Secretly, tho, I am ecstatic to be able to complain that I WALKED AROUND at another moronic festival. It's better than not walking around at all. Which means that, despite the fact that I know it will suck, I'll probably try it again next year.... just because I can.

Regenerate Myelin?

2009-05-16T16:44:00.001-04:00

Interesting article I came across today...

Researchers Identify Pathway To Reactivate Myelin Repair

Article Date: 13 May 2009

UMDNJ researchers have identified a key pathway that could lead to new therapies to repair nerve cells' protective coating stripped away as a result of autoimmune diseases such as Multiple Sclerosis (MS). An article reporting their findings will appear in the May 13 online edition of the Journal of Neuroscience.

Myelin is fatty material that coats and protects the ends of nerve cells. The loss of myelin and myelin-producing cells impairs the ability of nerves to conduct signals. A severe loss may lead to erosion of nerve tissues and result in permanent damage.

"In people with MS that is relapsing-remitting, the body can replace myelin that has been stripped away," explained Teresa L. Wood, Ph.D., the study's lead investigator. "But, after repeated attacks, that process of replacement no longer functions well," she added.

"Our data demonstrate that a novel cellular pathway, called the mammalian target of rapamycin (mTOR), regulates the generation of new myelin-producing cells (oligodendrocytes) and the production of myelin in immature rodent cells," Wood said. She is a professor in the Department of Neurology & Neurosciences and the Rena Warshow Chair in Multiple Sclerosis at the UMDNJ-New Jersey Medical School.

More work is needed to determine if the key to reactivate remyelination is to stimulate the pathway or if environmental impediments, such as inflammation, also must be overcome to allow the pathway to function normally. "Now at least we know a target to go after to promote repair," she said.

The researchers' work may also lead to new therapies for other disorders where the myelin-producing cells are affected, such as autism, Alzheimer's disease, and perinatal brain injury.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation's largest free-standing public health sciences university with nearly 5,700 students attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health on five campuses. Annually, there are more than two million patient visits at UMDNJ facilities and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a statewide mental health and addiction services network.

Pill vs Shot

2009-05-01T06:03:00.002-04:00

Just yesterday I was wondering if I took my pill already. I do that a lot. I need to use a pill box and then check to see what day it is and whether or not my pill for that day is gone.

I do use both Google Calendar and Yahoo Calendar reminder emails set to send out at 9am every day. I'm usually sitting at the computer so that works out well. But I had to make a plan to get up as soon as I see the email, take the pill, and then delete the email.

I seem to have a lot of short term memory issues and find that sometimes I get up, go to get the pill, realize my coffee needs warmed up so I can have something to swallow the pill with and I busy myself with refreshing my cup... only to find that I sit back down at the computer with a steaming cup of decaf and no pill.

I go back to checking email and see the pill reminder again. Then I sit there in a panic trying to rewind the DVR of my life to see if I took it or not, only to realize my life has no DVR or rewind button and what I see is that snow you get when you forget to pay the cable bill.

So, I now realize that the shots actually HAVE one up on the pill in the reminder category.

I never had to have a reminder email to do my shot. Not when I was on Copaxone, and not in the first part of this Phase III trial when I was *supposedly* injecting Avonex once a week but it turned out to be a healthy dose of IM water, no doubt. (I won't know until August, but I'm fairly certain I've been on fingolimod the whole time).

So, if I were sitting here wondering if I took my SHOT, I could just pat myself down until I found the sore, welted spot. The shot wins in the "I Know I Did It" department.

I think when I am done with the trial and go back to facing a choice in medications I'm pretty sure I'll opt for more email reminders or cellphone reminders or some other foolproof routine to use over the itchy, bruised, sore, welted shot reminder. True, it works well, but still.

New data released on Fingolimod FTY720

2009-04-29T10:31:00.002-04:00

I've been patiently awaiting the news from the American Academy of Neurology (AAN) congress, and here it is, hot off the presses...

Basel, April 29, 2009 - New Phase III results presented at the American Academy of Neurology (AAN) congress show that 80-83% of patients taking FTY720 (fingolimod)*, an investigational oral compound for relapsing-remitting multiple sclerosis, remained free of relapses during the one-year study compared to 69% of those on interferon beta-1a[2], an established standard of care[3] (p<0.001).

These data reinforce previous results from the TRANSFORMS study announced in December 2008 showing that the relapse rate at one year was 52% lower in patients taking FTY720 0.5 mg than with interferon beta-1a, or Avonex®** (0.16 vs. 0.33 respectively)[2]. The relapse rate with FTY720 1.25 mg was 38% lower than with interferon beta-1a (0.20 vs. 0.33, both p<0.001)[2].>

"TRANSFORMS is the first Phase III clinical trial to show that oral fingolimod may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis," said Jeffrey Cohen, MD, lead investigator of the TRANSFORMS study and staff physician at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research in Cleveland, Ohio, USA.

Also presented at AAN were longer-term results from an ongoing open-label Phase II extension study (n=155)[1]. This showed continued low relapse rates after four years of treatment with FTY720, with no significant change in the safety profile from three to four years[1].

In TRANSFORMS, FTY720 was generally well-tolerated with 87% of FTY720 patients completing the study on treatment[2]. The most commonly reported adverse events, seen in more than 10% of patients in all three study arms, were headache, nasopharyngitis and fatigue[2]. Adverse events seen in FTY720-treated patients in TRANSFORMS included transient reductions in heart rate at the start of treatment, small increases in blood pressure on average, elevations in liver enzymes (also seen with interferon beta-1a)[2], and a small number of cases of macular edema. In terms of serious adverse events, infections, bradycardia and atrioventricular block, malignancies and dyspnea were reported in less than 2% of FTY720-treated patients[2]. Following the preliminary release of data in December 2008, a patient who had discontinued FTY720 treatment in August 2008 died from aspiration pneumonia related to a progressive neurological condition in February 2009. The exact nature of the underlying diagnosis is unclear, but viral testing has proved negative, including testing for progressive multifocal leukoencephalopathy (PML). A role for FTY720 could neither be confirmed nor excluded. In general, the safety profile of the FTY720 0.5 mg dose appeared to be better than that of the 1.25 mg dose.

Read the rest, including disclaimers, etc. [click here].

When you least expect it...

2009-04-28T20:08:00.002-04:00

Last night my old man ran out of cigarettes. He went to the convenience store to buy some more and happened to run into a guy he knows through a mutual friend. That's when he got the bad news.

Ted, our *mutual friend* had been murdered.

We had wondered why he hadn't been around in the past 6 months, but Ted's like that. He's an aging hippy that always has something going on, some new scheme to try and make money without actually working. Mostly it was selling collectible car parts on ebay and buying/selling property. He seemed to do well at both and spent his time however he saw fit.

To think he has been murdered and I'll never see his bearded grin show up at my sliding glass door again (which he knew ticked me off as I prefer to have visitors come to the front door and not scare the crap out of me), well it just leaves me really sad.

And thinking about how nothing we can do will stop the inevitible from becoming the Present. At some point, and the day will come, we will each face our mortality.

I can picture Ted standing here having this very conversation with me and giving me his philosophy on what comes after... I just can't believe he is gone.

Like dandelion seeds scattered by the wind, he is no more. And while we weren't the best of friends (and I often found myself ticked off at him for pushing my buttons which greatly amused him), I do miss him and now feel so vulnerable to the fragility of life itself.

And it was so pointless and preventable that it pisses me off that it happened at all.

He went to argue with someone he's had a long-standing feud with. I vaguely remember him recounting tales of why the two families (much like the famed Hatfields and McCoys) didn't get along.

But that was back in western NY state and altho he makes frequent trips between FL and NY to get car parts to sell on ebay, I thought the feud was all in the past.

Apparently it wasn't.

Ted went to the guy's house and fought with him in the driveway. When the guy ran into his house, Ted followed full of rage. The man ran to his bedroom and locked the door behind him. Ted, unarmed but angry, stood outside the door yelling at him to come out and banging on the door.

The man in the bedroom had a shotgun.

One blast through the door and Ted, who only had words as a weapon, lay dying on the floor.

The man who shot him calmly called 911 after bystanders to the incident tried unsuccessfully to administer CPR, and reported that he needed the cops to come because he had just killed a man.

And with that, Ted's laughter, wise-ass comments, eagerness to lend you a hand, and gentle friendship was extinguished forever.

I just can't picture him as the "aggressor" in a confrontational situation, but everyone has lost their temper before. Now I wish I had paid more attention to the stories of why they had a beef to settle. Then maybe I could see why Ted had become so angry and chased the guy right into his home.

In NY state, you can shoot to kill if you are in fear for your life. The grand jury decided that is just what this guy did and that he had every right to. Never mind the long standing feud, or the fact that Ted was unarmed. He made a poor judgment call to visit this guy... and paid for it with his life. My guess is that no matter what the problem was, Ted wouldn't have thought it worth losing his life over. Nor taking one.

Can you picture a hippy all laid back and grinning with his long hair, beard, faded, ripped t-shirt, holey jeans and tennis shoes held together by duct tape doing such a thing? I can't.

Death is a slap in the face. Death is ugly. Death is unfair. And death keeps stealing my friends.

I feel like it's circling me.

The worst part about all of this??

The indignity that I can't find a single obituary or eulogy to Ted. The newspaper story just has him as the victim of an incident. It didn't even humanize him. It was all about the other guy.

Now that I've read that and seen the outcome of a story about a person I knew pretty well, it makes me wonder about our whole justice system. True, I wasn't there and Ted could have been menacing and maybe scared the other person bad enough to use deadly force...

Or maybe the guy set him up, running right to his gun and figuring he'd end it once and for all. A trap that he knew he'd get out of by playing the self defense card. Finally winning the feud once and for all.

Who knows.

But the fact that he's gone and life goes on and it seems just like he never existed... that creeps me out and pisses me off. Something ought to have changed because of his having been here, and there should be some kind of hole -- other than the one in my psyche -- that is left by his absence.

Not one line in the local paper.

Just a For Sale sign in front of his house.

So, that's why I'm writing this. Something needs to be out there somewhere to say goodbye to Ted.

We loved you (sorta, ya big lug) and will miss you.

We'll miss you showing up in God knows what kind of new clunker you got for a song so you can rev it up in the driveway and ask the old man what he thinks that noise might be.

I'll miss looking casually over to the back door and jumping out of my skin because you freaked me out by standing unannounced on my back patio.

I'll miss the way you kept trying to talk me into helping you with your real estate ventures, and trying to get me to make that website for your car parts.

I'll miss how you knew it all, or thought you did.

I'll miss how you told such wacked out stories that we never believed you once you had some Jack Daniels in you.

Guess maybe we should have paid more attention.

I'll remember your wave as you left on your trip to NY. "See ya!" you yelled.

In heaven, Ted.

Someday.

I can't believe it took this long...

2009-04-20T07:02:00.003-04:00

...to finally get called for jury duty. I thought I had managed to fly under the radar and escape detection. Oh well. It was fun while it lasted.

Today I have to report to the courthouse at 9 am, paper in hand. First off, I can't believe they would send me a piece of paper a month in advance and tell me that I had to bring it to court. If I so much as open the electric bill and set it down I can't find it 10 minutes later. I have spent a solid month stressing over making sure I'm constantly aware of where that paper from court is at all times.

I pinned it to my cork board, but I so rarely do something like that that I worried I wouldn't think to look there. Then I put it on top of the stack of stuff in front of my computer but fretted that it would be buried in the chronological order of stuff that piles up there. Then I folded it up and stuck it in my purse.

I rarely, if ever, carry a purse. I'm a license in my back pocket, money in the front kinda gal. I don't carry around makeup because I don't wear it, and all that other junk that women tend to haul around just seems better left at home to me.

But I figured if I put it in my purse, and then trained myself to use the purse that by the time I went to court I would have the whole dilemma solved. So I've been carrying around this little canvas satchel for a month now. Well, not always carrying it around because there have been 3 times I had to return home for it because all my money now resides there and the grocery store no longer takes wampum. Besides, I wasn't totally sure what "wampum" was and didn't want to seem ignorant at the checkout when trying to pay with parking lot scrapings.

So, now I am trained, partly, to carry a purse. The letter is neatly folded in the purse. My bifocals and car keys and license and money are also in the purse so as to remind me that I need to strap on the canvas satchel before leaving the house. Thus I will "remember" the letter because I can't possibly leave without it.

I tried all this with the corkboard first, but that was awkward to carry around.

Anyhow, all joking aside, while I am more than ready to do my civic duty and serve my community by screaming out "hang the bastard!", I am more terrified of this than I am about having an MRI.

Maybe because I have had that "conditioning" treatment when you are faced with your fear repeatedly in order to overcome it. (Not out of choice, but I've had a few more than normal due to this clinical trial).

The thought of standing before a room full of people and having to recount any mundane details of my life has me locked in fear. I once tried to get a permit for a conditional use for my home so that I could operate my print shop out of the garage. I had to speak before the city board and the general public gathered there. When I spoke it sounded more like a croaking frog chomping down on a squealing mouse. My words came in grunts and squeaks.

It was then I realized I'm no public speaker.

So today, if my attempt to play the MS card and get out of all this stress inducing circus fails me, I will at least have an opportunity to face my fear of public speaking and hopefully overcome in with a minimal amount of embarrassment and a semi-human speaking voice.

If I can just get past the "it's all about me" part, then jurors get to sit back and shut up. The worst part will be over. And I have learned to sleep sitting up, so I'm good to go. :-) (you know I'm kidding, don't ya?)

If I get picked for some juicy trial I'll blog about it after it's all over. I've been looking for something to talk about anyhow.

wish me luck (croak).

From my google alert email yesterday...

2009-04-16T14:59:00.002-04:00

I like the news I just posted about fingolimod from the Rocky Moutain MS Center's newsletter...

I don't so much care for this news that broke yesterday on Reuter's:

Patient on Novartis’ MS Drug FTY720 Gets Hemorrhaging Focal Encephalitis

April 14, 2009

Novartis (NVS) is reporting that one of its shining star drugs in development may be in trouble. Doctors in the trial for FTY720, also known as Fingolimod, have reported a case of hemorrhaging focal encephalitis in one patient. The company said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.

Eric Althoff from Novartis commented on the scenario:

“As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators. It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed.”

FTY720 works as an immunosuppressant, causing lymphopenia by preventing lymphocytes from leaving lymph nodes. The drug has already demonstrated superiority over Biogen’s Avonex and is currently in an ex-US Phase 3 study called FREEDOMS I. The trial is comparing two doses of the drug vs placebo in 1,272 MS patients.

The drug is a potential star because it is given orally (all MS drugs on the market are injection) and has already demonstrated superior efficacy over Avonex. The main concern is safety, safety and safety. Up until now, the known safety issues had been transient heart rate reductions, elevated liver enzymes, skin cancer, infections (there have already been two fatal viral infections) and minor increases in blood pressure. This is the first serious brain inflammation case in the trial which would put concerns about the drug’s safety right up there with Tysabri.

The safety issue might be a positive for Merck’s cladribine which is in a race with NVS to become the first oral MS therapy. Cladribine also had some issues earlier this year when the company reported four patients had died of cancer.

*********************************

It's weird. Even though I'm a full-fledged, professional, card-carrying Hypochodriac, the news of the bleeding brain infection (as far as I can figure, that's what Hemmorhaging Focal Encephalitis means) does not stun me into a frozen state of panic whereby I am unable to ingest my daily pill.

On the contrary, I get up and yawn and stretch with eyes still half closed (regardless that it's the crack of 9a.m.) and slug my little capsule down with a swig of decaf. Oblivious to any idea that should be swelling up in my subconscious that my brain may get infected and bleed.

I just can't seem to muster the fear. I guess it's because I tell myself that when complications like this arise, I don't know the full back story and the poor person that had these complications obviously was not well by definition since we all (in these clinical trials) have a MS diagnosis. I feel like since I quit smoking, started eating better and got on this trial, my MS has been whipped into submission and I'm actually quite healthy.

That reminds me of the one time I saw an eye doctor in the study. I forget how it came up, but I replied to whatever the question was with : "other than having MS I'm healthy as a horse."

He just stared at me before bursting out laughing. I, at first, couldn't see the humor, but I guess to someone who doesn't HAVE MS, the diagnosis must seem like the ultimate branding of Incurable Illness. I tend to see it as an annoyance and a Life Obstacle. We all have them. Mine just happens to be MS. That doesn't mean I can't be *otherwise healthy*.

So, while this isn't the greatest news for the clinical trial, I'm not personally freaking out or losing sleep or pausing before tossing back my pill.

Read the packaging insert that comes with your aspirin. Even that stuff can cause death. Everything in life is a gamble. And I'm all in on this hand.

From the Rocky Mountain MS Newsletter

2009-04-16T14:57:00.001-04:00

I just received my copy of the Rocky Mountain MS newsletter and the very first article was an update on Fingolimod:

Fingolimod is an oral agent that is now being researched in three Phase III trials. This is the first of a new class of potential MS medications known as "S1P receptor agonists," which work by keeping certain immune cells out of circulation. It does not kill immune cells, but rather "locks" them up in the spleen and lymph nodes, which means that if patients stop the medication, their immune system will be back to normal within a week. The recently reported results of one phase III clinical trial of Fingolimod, TRANSFORMS, has shown that Fingolimod is more effective than interferon beta-1a (Avonex), which is currently a standard of care in the treatment of MS.
The study calculated the annualized relapse rate at one year in patients given one of two varying doses of Fingolimod or an injection of interferon beta-1a. Patients given Fingolimod 0.5 mg exhibited a 52% reduction in relapse compared to those given interferon beta-1a. Those given Fingolimod 1.25 mg also showed a significant reduction in relapses (38%) compared to interferon beta-1a. Both doses met their primary outcome measure – a measurement that is required by the FDA to determine the effectiveness of each study drug – and there was no statistically significant difference seen between the two doses, meaning that the higher dose did not seem to provide greater benefit than the lower dose.
The safety profile of the therapy seen in TRANSFORMS was in line with previous clinical studies. The compound was generally well-tolerated and side-effects included fatigue and headache. However, like with all study drugs there are potential risks. Fingolimod does affect other organs, including the heart, liver and eyes. The therapy suppresses the immune system and there are concerns about the development of potentially serious infections and certain types of cancer, such as skin cancer. There were 7 cases of localized skin cancer lesions seen in the TRANSFORMS study, all of which were successfully removed. The benefit to risk factor of Fingolimod is still being researched and further study on the safety profile needs to be done; more detailed information will likely be released sometime this year.
TRANSFORMS is the first of three clinical trials of Fingolimod. The three different studies collectively will involve more than 3,400 patients from around the world. The two other trials, FREEDOMS and FREEDOMS II, which are both two-year placebo-controlled studies, are underway and results are expected later this year. Novartis, the company that manufactures Fingolimod, expects to send the drug to the FDA for approval at the end of 2009. It is currently unavailable outside of clinical trials.

FYI, I am in the extension phase of the TRANSFORMS trial mentioned above.

Sounds like good news, eh?

Yet another infection

2009-04-14T12:02:00.002-04:00

The day after my last entry (March 31) I awoke with a ticklish/scratchy feeling in my throat. Next day I was coughing and had a runny nose. 10 days later I was sitting in the waiting room of my primary care doc hoping to get squeezed into his busy schedule.

I had spent 10 days non-stop coughing. Day and night. I had almost developed 6-pack abs from all the effort, but that was the only redeeming factor in the plight that had seemed destined to become a way of life.

I'm one of these people who believe that "this too shall pass" and tend to wait out things like head colds hoping to rough it through the tough spots. But after 10 days of no sleep and barely being able to take a breath due to the coughing fit that inevitably resulted, I finally relented, suspecting an infection. Head colds don't last 10 days.

Doc saw me, listened to my chest and back, and told me it was Allergic Rhinitis which had become a sinus infection. Coughing was brought about by post nasal drip. (ewww)

I got a 5 day course of Zithromax and a script for some allergy meds, but I opted to take Benadryl instead since I know how that makes me feel. (I'm skeert to take any new meds that might make me feel dopy[er] so I usually tough it out with nothing).

But I tell you what... no cough drop or cough syrup touched my cough in all that time, yet 15 min after I took a half of my kid's melt in your mouth Benadryl strip (a quarter dose for someone my size/age) I was breathing free and my lungs could relax a little. Now 5 days after beginning the antibiotics I am back to being perfectly normal (as a oddball like me can be).

I guess this means I now have Seasonal Allergies? Nobody mentioned it, but what else could it be?

I can't believe it's been this long since I posted anything (sorry) but honestly, my life has become quite boring and Fingolimod isn't making any news.

Don't get me wrong, I'm not taking the fact that I haven't relapsed yet lightly. I still marvel on a daily basis that my body is acting normally and not shorting out.

OMG I just realized it has been TWO YEARS this month since my last relapse!!! Woohoo!! I mentioned it somewhere the other day that I hadn't relapsed in 20 months but it was definitely April of 07, so that means 24 mos. a.k.a. 2 YEARS! It's the longest I have gone since diagnosis. For real. wow.

No news is good news and you can't get much better than that. :-)

Since the vaccine

2009-03-30T13:54:00.002-04:00

We went last week and I toughed it out and entered the germ-laden office of my son's doctor. I imagined coming in contact with all kinds of deadly things while there, but here it is a week later and I am alive.

He got his Chicken Pox vaccine and ended up getting this golf-ball (diameter, not height and everything) size welt on him arm. He never got a fever, never got any other reaction, and did just fine. The welt is almost totally gone now.

I did fine, too. After learning of my immunity I guess I must have really sold myself on the belief that there was no way I could contract Chicken Pox due to my "super power" like immunity levels.

Of course, incubation for the virus is at least 10 days from exposure, so, um, I guess I'm really not out of the woods yet....

Whew! There's the hypochondriac I know and love. I'm back!

No news on the Fingolimod front is always good news.

Another boring normal day -- and I'm thanking God for it and loving every minute of it! :-)

What the trial nurse had to say about the chicken pox vaccine

2009-03-24T21:24:00.002-04:00

I never got a call back yesterday after my frantic efforts to contact my clinical trial nurse on Friday in reference to my 10 year old's appointment today for his physical and vaccinations.

I called her this morning and apparently she never got my message. When I asked if it was ok for my son to get vaccinated, she misunderstood and asked if I meant that I wanted to get vaccinated.

I said "no! It's just that the new consent form had all that added stuff about not being around people with chicken pox or those who had been recently vaccinated and I just wanted to make sure I do the right thing. If he's not to get vaccinated, then I'll send someone else to take him to the doctor's office so I'm not exposed to kids with the pox, and I'll let them know not to give him the shot."

She said "let me check your file and I'll call you back".

Within 10 min. she had located the results of the lab work that Novartis had done on me, same as all the rest of the trial participants in light of the 2 deaths from viral infections related to chicken pox.

She said "Oh, you don't have to worry! You have a strong immunity. In order to be considered a positive test for antibodies sufficient enough to allow you to stay in the study, you must test at a level of 1.0. Your levels are 1.70. You are very immune, so don't worry about it. Go get your son vaccinated and don't be afraid of the doctor's office."

I breathed a sigh of relief in knowing that I could accompany my son and get all the dirt from the doctor first hand instead of trying to rely on John for any details. Whew.

Being the compulsive worrier that I am, though, on the way to the appointment it occurred to me that lab results are often misread or inaccurate....what if....

Nooooooooooo! I have to quit thinking like that! But I am a card carrying member of the WCSDDA. AKA Worst Case Scenario Day Dreamers' Association. You cannot possibly know or control what the future has in store, so why not imagine the worst case scenario and then be pleasantly surprised and relieved when you survive another day?* It makes living on the edge more attainable for those folks who don't have the finances to go sky diving or mountain climbing. For those of us who have mundane lives, the WCSDDA is a way to invigorate yourself and keep your pulse pounding.

*Not for the feint of heart or for that matter, not recommended for people who have no imagination.

Avoiding a virus you can't see

2009-03-22T05:43:00.002-04:00

Just how do you do that? Avoid something that is common, yet unseen?

The informed consent I had to re-sign the other day at my 18 mo. study checkup specifically stated that it could lead to fatal complications to be exposed to the Chicken Pox virus.

I read the words knowing that Novartis has to cover their butts and include anything that could possibly happen in the informed consent, so I wasn't really all that alarmed about it. After all, I already have HSV in my system so I'm not really sure I can even GET chicken pox. I don't think I would be as susceptible as say someone who has never had any type of herpes related viral infections.

I left without a copy of the informed consent -- that's how worried I was -- I forgot to even get my copy.

But on Friday a routine call to my son's doctor's office left me rethinking my level of concern over this new instruction warning me to stay away from anyone with Chicken Pox or anyone recently vaccinated against it.

My son has asthma and he's on Singulair and Brovex as maintenance therapy that seems to (finally) have his breathing issues under control. He ran out of Brovex and there wasn't another refill left, so I called his doc's office to see if they could call it in for me.

Then it occurred to me that he really needed his yearly physical, so why not schedule that at the same time? I got an appointment for next Tuesday.

As we were about to conclude the call I said "oh, one more quick question..." and proceeded to ask if they used a live virus for Chicken Pox vaccines and if they had many kids coming in lately with Chicken Pox.

Once I explained why it might behoove me to know the answers, she got the nurse to call me back.

Turns out they do use a live virus. I had gotten that confused with the Polio vaccine (I think) that they used to give a live version of but don't any more. The Chicken Pox vaccine is live and always has been.

So my dilemma is, do I go with him to the doctor's office and just wear a mask and take my hand sanitizer with me? Do I take that risk and expose myself to possible contact with the virus? If I choose not to go, however, then I'm not in full control of the interaction with the doctor. I really like having first hand knowledge of what the doc has to say straight from his mouth and not a "he said something about something" version from someone else (i.e. John) who might not a) pay attention, b) understand c) worry enough to ask the right questions in response.

A true hypochondriacal worrier's nightmare!

Of course, the equal and opposite worry is that I will contract Chicken Pox and it will eat me alive and kill me while Novartis looks on and shakes their heads and "tsk tsk's" me because they told me so and my 22 sets of initials and one full signature prove that.

And on top of that, the nurse said my son is due for his shots. One of those is the Chicken Pox virus that "they" are recommending everyone get revaccinated with these days.

Obviously he can't get his vaccination while I'm in this study, but what about later? I mean, it's my deep desire and greatest wish in the world that I get to stay on Fingolimod (despite it's stupid name) well past the end of the trial and on into my golden years after it gets approved.

What does this mean for my kid? He will be always vulnerable to Chicken Pox? Or does the fact that he already gets wicked cold sores (a strain of the herpes virus that also causes chicken pox) mean that he's got some build up of antibodies?

I sure wish I knew the answers. It's not just the strategy of how to get him seen by his doctor without unnecessarily exposing myself to the virus that is the issue. He's a kid who goes to public school. I spend some of my time at that school, around lots of kids. I go grocery shopping...where there's lots of kids. I go to Wal-mart...where there's lots of kids.

How does one know if someone is contagious? And is it airborne or can you only catch it from direct contact? These are some pretty important questions that need to be answered given that I have a 10 year old, I have to buy groceries, and I tend to go to Wal-mart for stuff that I absolutely can't find to buy online or don't want to pay shipping for.

Trust me, if I could order groceries online and have them delivered, there would almost be no reason to leave the house and that would be fine with me. Getting out of this place via the portal of my computer monitor is escape enough. I like my life, I like my plot of land and my little abode. If I didn't kill every plant I ever touched, I'd plant a garden and have less reason to ever leave.

But, since I have brown thumbs and a kid who attends public school, avoiding the world beyond my staked out territory is impossible.

I put in a call to my study nurse and hopefully she'll call back on Monday so I know what to do on Tuesday for the appointment. I have half a notion to make John take him, but when they get in the exam room, to call me on the cell phone so I can listen in and ask the right questions, besides hearing what the doctor says first hand.

And someone has to remember to tell him not to vaccinate our son. I guess I could always pin a note to him with all the info on it. (our kid, not John)

When the trial nurse has given me the best plan of action, I'll post back the results.

18 month milestone

2009-03-20T20:26:00.002-04:00

Today marks exactly 18 months since I popped that first little mauve capsule and wondered "what the heck have I just done??!!!" and proceeded to worry about all the side effects to which I would soon be subjected.

I went yesterday for my 6 month Extension Phase checkup. Everything went really well!

I'm most proud of my performance on that numbers test thing. The one where they play the CD with the smug guy spouting numbers and you have to add together each pair. He says "Seven.....Nine" (you say "16) he continues with "5" (and you have to throw away that 16 you said and add 5 to the last number he said -- in this case 9 -- and say "14").

Out of the 60 consecutive numbers that he said, I missed ONE (1) (yes, count them...O-N-E) number!! I was so proud of myself. The lady testing me was pretty impressed, too.

The peg test went as it normally does. I fight getting them out of the bowl, putting them in the little peg holes and getting them back out to drop in the bowl again. I guess I do it in pretty good time, but I feel so uncoordinated while I'm doing it. My hands don't do the minutia the way they used to.

At my PFT (pulmonary function test) the guy who did it is the guy who always does them and has since my very first one a year and a half ago. He commented that, while I had been within the normal range on my very first test, it "seems like that stuff must be doing good for your MS because you don't seem nearly as weak as you did the first time I saw you."

Hey, at 48 I guess that's about as good a compliment as I can expect. I'd have rather heard "you look 20" but I'll take what I can get.

I got hooked up to the spaghetti mess of carburetor wiring and had an EKG. She swore I moved and I swore I held still. We both agreed it would just have to do.

I had lots of blood taken, peed in a cup, and had my EDSS test.

For those of you not familiar with an EDSS test, it goes something like this:

The neurologist examines you and has you follow his finger with your eyes while you hold your head still. (looking to see if you can track in a smooth motion with no jerkiness)

Then he touches your face with both hands in a gentle brush at forehead, cheeks and jawline while asking if it feels the same on both sides.

Then you have to smile real big and stick your tongue out and say "AH!"

He asks if you have any trouble swallowing or eating.

He then checks for weakness by having you push and pull against his resistance with each arm, and then each leg. He has you make a fist and has you pull and push against him with that to check the wrist.

Then he gets out this cold metal thing that buzzes when he wacks it with his hand. He places it against fingers and toes while having you close your eyes and tell him when the buzzing ceases and you can no longer feel the vibrations.

He asks if you feel the cold when he touches your body on each side in various places with that (apparently multi-purpose) gadget that was just buzzing a minute ago.

He has you close your eyes and he bends your fingers and then your toes both up and down, asking if you can feel in which direction he just bent said appendage.

He gets out the little triangle rubber mallet thingie that he wacks you with on various reflex points, knowing to stay well to the side of the flying feet when he wacks the knees. (I can cause my leg to fly out just by slapping my thigh when I laugh hearing a good joke. Never stand in front of me and tell a joke.)

He has you walk across the room doing the heel to toe drunk walk. Then you stand, feet together and arms straight out in front of you, palms up. He has you close your eyes and then he catches you when you fall over (as I did).

You walk on your tippy toes, you walk on your heels, you hop on one foot and then the other.

Then he asks you a bunch of strange questions while rating you from 0 to 4 on each answer (I think it's 0 to 4). I score 1 on a few answers but mostly 0s.

The questions are ones like "Are you depressed?", "Are you happy for no reason?" (like one must have a reason to be happy because life sucks and anyone that is happy for no reason must have a big MS lesion right over their sane spot on their brain.)

"Do you have any problems with bladder or bowels?" (no comment)

And a bunch of other stuff I don't remember...oh! One question was "has your MS interfered with your sex life?" and I answered "I don't know, I don't have sex." To which he actually chuckled and said "you said that 6 months ago, too." To which I responded with "If I had sex, it probably would interfere with my MS life, so I don't bother." Like people can't actually be happy and have a fulfilling life without sex?? I beg to differ...but that's another story.

Then after the game of 20 questions comes The Walk.

The dreaded walking of the hallway 25 times...to equal 500 meters. OMG it just KILLS me to walk that stupid hallway. I hate it. I did very well, completing the 25 laps and not crashing into anything although I tripped over my own feet on the very last lap and stumbled to the finish line. But I made it.

And that pretty much sums up the EDSS test.

There were a bunch of MS patients there yesterday. I know because they were all having to walk the hall and I don't believe they subject any other neurological group of patients to that particular punishment.

After all that I got my new meds (the real reason a fingohead like me shows up for the appointment in the first place) and had to sign yet ANOTHER informed consent.

This one was 23 pages long and now they have you initial every page along with the grand finale signature at the end.

I actually read all the new stuff in the adverse events section and found they had added a big section relating to the issues surrounding the earlier deaths in the study.

Now they make you well aware that anything related to the herpes virus is a dangerous (possibly lethal) thing to come in contact with. You are warned not to get vaccinated for chicken pox or to come in contact with anyone recently vaccinated, and to stay away from anyone who has Chicken pox, shingles, viral meningitis, herpes, etc.

Kind of hard to do considering my own HSV diagnosis, but nonetheless...

So, what started as a routine call to my son's doctor's office today to get a prescription refilled for his asthma ended up being a long drawn out strategy session about how to get him to the office for a physical that was due when many of the patients coming and going are going to either have chicken pox or have just been inoculated against it in the office.

They use a live virus for the vaccine.

I have a call in to my trial coordinator about what a regular person who has a life outside of being a guinea pig for science is supposed to do when their kid is due for a vaccination. Just how long am I supposed to avoid chicken pox exposure?? For the rest of my pill-popping life?? No answer on that yet, but I'll post the answer when I get one.

Anyhow, it was a great checkup. I was happy with how happy everyone seemed with my progress.

And now it's been something like 23 months since my last MS attack... I know it was April of 07 that was the last time I had steroids. I don't miss them one bit!

Normal, boring, everyday life is a damn nice thing to experience. I could get used to this all over again.

Here's hoping for another 18 months just like the last 18 months. Cheers!

So soon?? Will the party be over?

2009-03-06T12:03:00.002-05:00

This just in, from a Google alert sent by email:

*****************************************************************

ZURICH -(Dow Jones)- Novartis AG (NVS) chief operating officer Joerg Reinhardt said Wednesday Novartis plans to file experimental multiple sclerosis pill FTY720 for regulatory approval before the end of this year.

Reinhardt was speaking at a press conference to detail the pharmaceutical company's fourth-quarter earnings.

Company Web site: www.novartis.com
-By Anita Greil, Dow Jones Newswires; +41 43 443 8044 ; anita.greil@ dowjones.com
(END) Dow Jones Newswires 01-28-09 0426ET
Copyright (c) 2009 Dow Jones & Company, Inc.

*****************************************************************

So, the GREAT news is the drug will be submitted for approval by the end of this year...

The news that is between those lines is that my free drug ride may be ending sooner that I hoped.

Don't get me wrong -- I'm thrilled that the MS population will be able to finally have a pill added to their choice of CRABs, but I don't know where I'm going to get the money to pay for this stuff when they start charging. As soon as it gets approved, I've got to fork over money for the stuff. I'm uninsured and don't qualify for Medicaid...what am I going to do??

I sure wish part of the agreement to enter the clinical trial had been "free medication for life". Would it really have put that big a dent in Novartis' pocket to take care of us guinea pigs who so graciously allowed the experiment to proceed to the point at which their cash cow will be ready for milking??

It's my anniversary!

2009-03-04T08:33:00.002-05:00

I'd be excited if it were "of the day I graduated from MIT" or "of the day I sold my first oil painting" or "of the day I received the Congressional Medal of Honor"...but nooooooooooo.

It's the 10th anniversary of my MS diagnosis. Oh boy.

But, even though it's not really the kind of milestone you celebrate -- and I can see my sister now, quickly yanking the balloons down behind her back and throwing a dishtowel over the cake -- it's still a time for reflecting.

I vividly remember the day of my diagnosis. I actually was diagnosed a week or two before that, but I went to the head of the neurology department at Shands Hospital at the University of Florida in Gainesville, FL for a second opinion.

When that second doc confirmed what the first one said, that's when I gave up hope of thinking the first one was off his rocker and it was all just a big tadoo over a pinched nerve or something.

I drove myself home somehow. It was an hour ride in the silence of my own car, by myself, crying the "poor me" freakout cry.

I remember thinking first of my son who was not yet quite 6 months old. What kind of mother could I be? Since my neuro told me he had seen a lot of MS patients and he felt my case was "particularly aggressive", I was certain that death in a matter of a short time was imminent.

My mother knew a woman with whom she used to work who had been diagnosed 10 years prior. She was on Copaxone and had been in the clinical trial for it. Before that her husband had raised bees and they tried the bee sting therapy. She looked wonderful and had not had a relapse in many years. She didn't have any outward, telling signs of MS, and that gave me hope for my future.

I remember thinking..."what will I be like after 10 years??" and all the answers I conjured up terrified me. If I hadn't killed myself off, I had myself at the very least bed ridden.

Now, on this day of reflection, I think I want to see those balloons and have some of that cake after all, Lorraine. I've had my ups and downs and some really scary relapses that I wondered "is this the big one?", but I'm here. I'm walking, running and jumping, loving, eating, breathing, laughing, writing, complaining, joking, taking my pill and happy to be alive.

So for all you newly diagnosed, take away this nugget: I feel better now than I did 10 years ago. It doesn't all have to be gloom and doom. While MS is a devastating disease and has robbed so many of so much, you aren't automatically sentenced to that end of the spectrum.

I thank God every day for the fact that I have regained nearly all I have lost from each relapse.

MSers have a way of being thankful for the little things that the rest of humanity takes for granted.

Every morning when I get up and the carpet tickles my feet, I am amazed I can feel it... and I say "thanks, God," in my head. I know what it's like not to feel that, and I didn't like it one bit.

So, it might seem weird to say, but so far, I'm having a very happy anniversary! :-)

Novartis / Fingolimod (FTY720) in the news again...

2009-02-13T02:49:00.003-05:00

An interesting article...

MS Drug Prize of $1.3 Billion Spurs Merck KGaA, Novartis Race

By Naomi Kresge

Feb. 13 (Bloomberg) -- Merck KGaA and Novartis AG are racing
to market the first multiple sclerosis pill, a prize that may
generate $1.3 billion a year in sales as patients switch from
injectable drugs.

Merck and Novartis plan to ask regulators this year to
approve tablets to fight the incurable illness. Initial test data
showed that patients who took the drugs had fewer disease flare-
ups than those who received placebo or existing treatments.

A pill may mean an end to painful injections or infusions
that can cost $28,000 a year to control multiple sclerosis, which
can rob people of their mobility and leave them with chronic
aches and depression. Merck, of Darmstadt, Germany, and Novartis,
of Basel, Switzerland, are running ahead of Teva Pharmaceutical
Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the
chase for an oral treatment. The results may shake up the $6
billion multiple sclerosis market.

“It’s going to be a neck-and-neck race between Merck and
Novartis,” said Markus Mayer, a Munich-based analyst for
UniCredit SpA, after Merck released initial data last month.

The Teva, Biogen and Sanofi pills may not reach patients
before 2012, according to Jack Scannell, an analyst for Sanford
C. Bernstein Ltd. in London. Frost & Sullivan, a research company
based in New York, predicts the market for drugs to treat early
stages of multiple sclerosis may double by 2013.

Merck fell 73 cents, or 1.1 percent, to 67.37 euros in
Frankfurt trading, while Novartis shares climbed 42 centimes, or
1 percent, to 42.51 francs in Zurich.

Cancer Cases

Merck said in January that four patients were diagnosed with
cancer during the late-stage trial of its medicine, known as
cladribine. An independent monitoring board didn’t consider the
cases a safety concern because there were too few to show a
statistical significance, said Phyllis Carter, a Merck
spokeswoman.

Conceived as both a leukemia and multiple sclerosis drug,
cladribine was approved to treat the blood cancer more than 10
years ago and has been used by doctors in injected form to treat
multiple sclerosis in so-called off-label use.

Novartis has also reported two fatal infections and seven
successfully treated cases of skin cancer in patients who took
its candidate, FTY720. Final test results later in the year will
demonstrate how safe each of the medicines is.

If the tablets aren’t linked to such side effects, either
could “revolutionize treatment,” Citigroup analyst Mark Dainty
wrote in a note to clients in January. The products may generate
a total $2.6 billion in revenue in four years’ time, according to
the analyst.

Vulnerable

Merck’s existing drug Rebif, which is injected by the
patient three times a week, had revenue of 1.22 billion euros
($1.57 billion) in 2007. Rebif loses patent protection in 2012,
leaving the German drugmaker vulnerable to generic competition.
Merck reports fourth-quarter results on Feb. 18.

Rebif vies with two other so-called beta interferons, Betaseron by Bayer AG and Biogen’s Avonex, and with a fourth injected therapy, Copaxone from Sanofi and Teva. Interferons generally cut patients’ rate of flare-ups by about 25 to 30 percent, Scannell of Bernstein said. To take over the market, the oral medicines first need to overcome safety concerns.

“Concerns over cancer and opportunistic infection are the
real barriers to what could be substantial first-line use in a
multiple sclerosis market worth around $10 billion a year,”
Scannell said in a note to clients this week.

Infection Risk

Unlike interferons -- genetically produced versions of
natural proteins that suppress the entire immune system --
cladribine and FTY720 affect only certain types of cells, said
Doug Brown, research manager for the Multiple Sclerosis Society
in London who doesn’t have financial ties to either Merck or
Novartis.

The pills work by lowering the amount of immune cells in the body, leaving patients susceptible to infections, Brown said.

Long-term side effects from cladribine are unproven because
leukemia patients took the drug on a shorter-term basis than
multiple sclerosis sufferers would do, he said.

“We don’t see anything in the study that could prevent the drug from being given to patients,” said Bruno Musch, head of global clinical development unit for neurodegenerative diseases for Merck, in an interview before the preliminary results were released last month.

Emma Delahay, 30, a multiple sclerosis patient from
Canterbury, England, who started taking injected Rebif about two
and a half years ago and has since switched to Copaxone, said she
suffered side effects, including skin rashes, while she was
adjusting to the shots.

Disruptive

A pill would end the disruptive after-dinner routine of
organizing syringes, preparing her shots and choosing a new place
to inject herself every day, she said.

“Even though I can inject as part of my daily routine now, it’s still having to prepare myself,” she said. “With taking an oral therapy, it would be a second. With my injection, even though it’s not that long, it’s five or 10 minutes. It’s the preparation time, making sure my injections get stored properly.”

Merck’s study results suggest cladribine and FTY720 could be
as effective as Tysabri, the newest injected multiple sclerosis
drug from Irish drugmaker Elan Corp. and Cambridge,
Massachusetts-based Biogen Idec Inc., according to Scannell.

Tysabri has been plagued by safety concerns, with Biogen and Elan pulling the drug temporarily from the market in February 2005 after two patients died of a rare brain infection, progressive multifocal leukoencephalopathy. Five patients taking Tysabri have been diagnosed with the infection since it was reintroduced to the U.S. in 2006. One patient died.

Risk-Benefit

For patients, “it will be a case of weighing up the risk-benefit,” said Brown of the U.K. multiple sclerosis group.

“Doctors and neurologists will be weighing it up as well.”

In tests, cladribine reduced the relapse rate for the disease by more than half compared with patients given a dummy pill in a two-year study, Merck said last month.

The pills, like the injected therapies, work against so-
called relapsing-remitting multiple sclerosis, the most common
form among the estimated 2.5 million people with the disease,
according to the U.S. National Multiple Sclerosis Society.
Symptoms such as loss of vision and numbness flare up and then
subside, and the likelihood of full recovery can sink with each
attack. There is no treatment for rarer forms of the disease in
which patients experience a steady decline.

$1 Billion a Year

Merck, which isn’t affiliated with U.S. drugmaker Merck &
Co., said last fall cladribine could be its next $1 billion-a-
year seller.

In December, Novartis said patients who took its candidate, known generically as fingolimod, had 38 to 52 percent fewer attacks than those on Biogen’s Avonex.

The Novartis pill may surpass $1 billion in annual sales,
Chief Executive Officer Daniel Vasella said on a conference call
with analysts on Jan. 28.

The Swiss company made its first foray into the multiple-sclerosis market this year with Extavia, an injectable interferon identical to Bayer’s Betaseron. Extavia was introduced last month in Germany and Denmark. Extavia will be important for Novartis to gain a foothold in the multiple sclerosis market before it begins selling FTY720, Vasella said.

To contact the reporter on this story:
Naomi Kresge in Zurich at
nkresge@bloomberg.net

Last Updated: February 12, 2009 18:00 EST

Suldog: Michelle Hickman Gave Me PD!

2009-02-10T07:08:00.001-05:00

Suldog: Michelle Hickman Gave Me PD!

For all you bloggers out there who have ever taken part in the ritual of passing around the blog awards, you have GOT to read this.

Hot beverage warning level: 10

You will be erupting in uncontrollable laughter, so be forewarned. Make sure to just drink water as it cleans off your screen with no residue. For even better results, drink Windex.

FTY720 and Bone Density

2009-02-09T05:35:00.002-05:00

So far, throughout this trial, I have done my best to keep up on breaking news about FTY720. The worst news yet came in February 08, a year ago now, when two deaths of trial patients taking FTY720 were reported.

Other news that has been reported include the fact that it has a 50% increase in relapse reduction over Avonex, and reduction in symptoms of clinical depression in MS patients.

Data from the six-month placebo-controlled Phase II study of once-daily oral FTY720 in patients with MS found that the proportion of patients with clinical depression was significantly lower in the FTY720 groups at six months compared to placebo. Depression is a common co-morbid condition in people with MS; the presence of depression in MS may reduce adherence to disease-modifying therapy and lead to higher rates of treatment discontinuation.

This is all wonderful news!

Then, this morning, as I'm sitting here reading news online due to not being able to get my TV fix of it (help! I'm being held captive in a home with a giant TV that gets no TV signal) I come across this article:

Scientists discover key factor in controlling the breakdown of bone

The chemoattractant sphingosine-1-phosphate (S1P), which is associated with the trafficking of immune cells into and out of the lymph nodes, also caused immature osteoclasts to mobilize.

That's a mouthful, no doubt, but from what I gathered after reading that paper is that they are discovering that FTY720 can play a roll in keeping the cells that cause osteoporosis from doing their dirty deed.

Hence it may someday be used as a treatment for Osteoporosis. They are testing out their theories in mouse models. Little old mice walking with canes and trying not to fall off their exercise wheels lest they break a hip, I guess.

I am so excited about this news!!

I have bone loss due to excessive steroid use during the first 8 years of my MS since Copaxone sucked for keeping my MS under control. I can't tell you how many times I have had IVSM, but I do know that I have shrunk in height by 1.5" and that's nothing to sneeze at, lest I break something.

I'm not always so good about remembering to take my Calcium with D pills, but I have only ever missed 2 Fingolimod capsules in the past 18 months (and that's only because I went out of town on both occasions and didn't remember until I was too far away from my pill bottle).

Maybe the FTY720 might be helping my bone density, maybe not. They didn't say if it at all affected the bone density of those who damaged their bones with steroid use. At least it wasn't bad news.

Until they try out FTY720 on those mice they gave experimental allergic encephalomyelitis (EAE) (which is the mouse equivalent of MS) who have also undergone repeated treatments with steroids, I guess we'll never know.