As the Fingolimod Blog Turns

As if there weren't enough drama in my life, we now have the added excitement of an impending hurricane bearing down on us.

"Will she get the biopsies in time?"

"Will she have to drive through hurricane force winds to make it to the dermatologist?"

Tune in next week for "As the Fingolimod Blog Turns".

Last week I thought we were only waiting for the main trial HQ in Berlin to approve my MRI. Now I have to get chunks of skin cut off like some sick hazing ritual to prove I am worthy of continuing with Fingolimod.

Truth be told, I'd probably let them shave me bald and tattoo "STUPID" across my forehead if it meant a new bottle of pills. I've become such a Fingolimod junky. Sheesh.

My trial coordinator called this morning but because I had an insomniac moment last night and didn't go to sleep until 3am, I was unable to make the 10 yard dash in the alloted 6 rings of my cell phone before it went to voice mail. I had to listen to her message instead of being able to ask a zillion questions.

She said (good news) that she had spoken with Berlin about my MRI and it had been accepted as satisfatory (meaning the image quality and not necessarily the radiological findings). Then she said she had brought up the argument that I had made for being allowed to visit the original dermatologist for the sake of keeping the experiment more scientifically accurate without a bunch of human variants (trying to appeal to their "logical" side that all scientists have).

They saw right through it, like great scientists do when examining data, and recognized the scared, whiny patient beneath. I have to have the biopsies before they will say I can be in the extension phase. Hey, it was worth a try.

This was just about all I could squeeze into my worry calendar and then I tuned into the weather channel. Shouldn't have done that. Bad mistake. There's a hurricane coming this way and the big white ice cream cone of uncertainty that has a black line going up the center (the storm's predicted path) had the ending dot for Wednesday at 8AM being more or less right out in my front yard. If you looked close enough at the map you could almost make out the pool in the back yard.

So now the woman who didn't like driving on a major highway (i.e. anything with pavement) on a sunny day now may have to brave the elements to stay in this study.

It really is feeling more and more like a hazing. The gods have found out that I will allow hunks of skin to be carved from my body in order to receive these drugs and so now they are saying "hmmmm, she didn't even flinch...let's see, what else we got? anybody? You in the back, Zeus, what's your suggestion? Oh!! That's a GOOD ONE!! Let's throw in a hurricane and see how she reacts."

This one's name is Fay and if it weren't for Fingolimod and how much I love it, I'd have said "F"s are bad luck for me. The only hurricane that ever *got* me was Francis in '04. We had a bunch of trees down in the back yard, some shingles ripped off the roof, and were without power in the middle of a Florida summer for 4 days.

I'm not really looking forward to Wednesday when the storm comes through...but if they tell me I can go have my biopsies that day, maybe there won't be any other idiots on the road and I can make good time. If you see any reporters holding onto a stop sign while they flail sideways in the wind for the dramatic effect like a flag at full mast, be sure to check out the background. You just might see a gray Dodge Ram 1500 inching past. That would be me, on the way to get these moles cut off.

And look! Besides a hurricane, they are predicting a major paint spill across the south east...or no, that's tropical wind speed probabilities. My mistake.

FTY720 may be a novel treatment against chronic viral infections

Just when I seem to be having a really hard time claiming my stake (or steak?) in the extension phase of the Fingolimod Phase III trials, out comes even more great news about the drug.

It seems that researches infected some mice with the mouse form of meningitis and, after 3 days of administering low doses of FTY720, the infection was cleared up. This is phenomenal news as they are discussing possible future trials in Hep C and AIDS patients.

Apparently the war your body wages against viral infections is usually fought in the lymph nodes. This happens to be where Fingolimod sequesters T-cells in order to prevent them from circulating and attacking myelin in MS patients which is why I've not had an MS flare in well over a year.

With the T-cells sequestered in the lymph glands, I guess there's more of them available to fight against the viral infections that try to replicated in the lymph nodes.

I don't pretend to understand it all, but it sounded like good news to me when I read the article that came out the other day.

Here's a recap of it:

London, Aug 14 (ANI): Researchers at Yerkes National Primate Research Center and the Emory Vaccine Center have found that trapping disease-fighting white blood cells (WBC) in the lymph nodes might be a novel strategy against chronic viral infections, such as hepatitis C and HIV/AIDS.

Senior author John Altman, PhD, associate professor of microbiology and immunology at Yerkes Research Center and Emory University School of Medicine, said that the discoveries are based on the study of two varieties of a virus that causes meningitis in mice.

Standard black laboratory mice can fight off infection by the Armstrong strain of lymphocytic choriomeningitis virus (LCMV), but are vulnerable to chronic infection by a variant called clone 13.

Altman and his colleagues found that infecting mice with the Armstrong strain sequesters white blood cells in the lymph nodes, while clone 13 does so less stringently.

Our hypothesis was that if we could artificially induce conditions like those produced by the Armstrong strain, it would help the immune system clear an infection by clone 13, Nature quoted Altman, as saying.

The researchers turned to an experimental drug called FTY720, which prevents white blood cells from leaving lymph nodes.

FTY720, also known as fingolimod, desensitizes white blood cells so they can't respond to the chemical messenger sphingosine-1-phosphate (S1P).

S1P also influences heart rate and smooth muscle contraction in the airways.

Altman said that the scientists had previously thought of FTY720 as something that suppresses the immune system.

While not approved for sale by the FDA, doctors have tested it for the treatment of multiple sclerosis and preventing kidney transplant rejection.

The researchers found that even if mice have a stable chronic LCMV clone 13 infection, treatment with FTY720 can still improve their immune response against LCMV enough to have them rid it from their systems.

FTY720 appears to prevent exhaustion in the group of white blood cells called CD8+ T cells, which are responsible for killing off other cells that become infected by LCMV.

Altman said that usually, the stress of infection kills some CD8+ T cells and leaves others unable to respond to the virus.

He said that it is unclear whether FTY720 resuscitates non-responsive T cells or allows new ones to avoid being killed off.

It's always the things you least expect

...that end up throwing the monkey into the wrench (or however that saying goes).

Today was supposed to be the ho hum, normal skin exam at dermatologist day. It's the very last test needed to complete my one year study and allow me entrance into the extension phase.

Of course it's located in Jacksonville which is a 2 hour drive, but luckily the appointment wasn't until 11am so there was no need to get up at the crack of dawn or anything. I left here at 9 and had a nice ride all the way up except for a little rain. It was so uneventful I worried I may have to pull over and catch a few z's because the monotony was bringing on fatigue.

Then a truck changed lanes and cut me off and I had to slam on the breaks. I was good to go, all juiced back up from adrenalin and never had to pull over to rest. I ended up 20 minutes early for my appointment.

After reading all the jokes in the new Reader's Digest I brought along, a nice nurse poked her head into the waiting room and said "Jeri?"

I followed her back to the exam room which had a chair, a table, and some weird looking equipment I can't even describe. She told me to undress down to undies and bra and sit on the table with the paper towel she called a "sheet" covering me.

I waited and waited and waited. I got really cold and just as I was seriously contemplating putting some clothes back on, a knock came on the door.

The doctor and her nurse entered. It's not the same doctor as last time because last time the doctor was a man. He had looked me all over and said there was nothing I should be worried about and he even let me show him a couple of bumps on my head that I've always wondered about. They were "nothing" as well.

This time, the doctor came in and walked around to the opposite side of the table from where I was sitting, so she was behind my back.

"Uh oh. I can see right now I want you to lie down on your tummy because I see a couple things I want to take a closer look at."

"You mean that skin bump on my back?"

"No, that looks fine, it's nothing. I see a couple really dark moles that are overlapping."

So I lay down and she turns on the spotlight above me. I guess that's supposed to make me hold still like a deer in the headlights or something.

She whips out a Sharpie from her coat pocket and proceeds to play Connect the Dots on my back, drawing circles around the "suspicious lesions".

She utters the words I had no idea I would hear and thus had not even sufficiently worried about: "I'd like to biopsy those."

"WHAT???!!!"

"Well, they're dark and irregular and are the kind of mole that could turn into skin cancer somewhere down the road. Doesn't mean they are now, but by biopsying them we get rid of them whether they are or aren't and you have the peace of mind that knowing everything is fine."

"I've had those moles ALL MY LIFE! Didn't the last doctor say anything about them?"

The nurse shuffles through the file and says "Yes, Dr. ___ did note them when he saw her last year."

To which the fine doctor replied, "Well, that's him. I'm sort of known for being the Biopsy Queen around here. I like to be better safe than sorry."

So, she has me turn over and she finds yet another reason to draw a one-eyed, mouthless smiley on my stomach. A tiny dark brown dot of a mole that I know has been there for quite a few years, and it's also noted in the file.

"Um, why are you circling that one?"

"We're going to biopsy it, too."

"It's just a speck. Once you have biopsied it, it'll be gone."

"That's the plan," She smiles.

The nurse pipes up saying "what kind of insurance did you say you have?"

"I didn't." I said, "I am hear being seen as part of a research study and the drug company is paying for everything."

"So are they going to pay for the biopsies?" she asks.

"I am SURE they will since it's their idea that I need to come see you and have my skin monitored anyhow. If you find anything to cut off, I'm pretty sure that's part of the deal. They'll pay."

"Well," says a skeptical nurse, "we'll need confirmation from someone in charge."

I tell them to call the Research Department at Shands Jacksonville. They make me wait there lying on the bed with that little paper towel for a sheet. The nurse comes back and says "we can't reach them. If we don't find out something in the next few minutes we are going to have to schedule for another day as we have a backlog of patients to see today."

In my head I am sighing a gigantic sigh of relief. I have not yet sufficiently worried about the ramifications of all this or how painful a biopsy or three might be. I need to go home and work up a good tizzy first that I can talk myself back out of.

So I leave and I am driving home. About 10 minutes out of the parking lot something makes me pick up the cell phone and just SEE if anyone called my trial coordinator.

She was surprised to get my call and even more surprised when I explained the situation, because nobody ever called her. She said she had gotten 2 calls earlier and when she answered the second one she asked them to hold, which they agreed to. When she came back, they were gone and no message had been left.

"So, these are new moles since your last visit?"

"No, it's just a different doctor who apparently likes getting her quota of $150 biopsies with every new patient she sees."

"So, she thinks these are cancerous lesions?"

"No, she thinks they probably aren't. But a biopsy of each one will leave no doubt."

When I tell her they won't do it until there's some guarantee of payment, she tells me to call them back and give them her cell and pager numbers and tell them it's imperative that I get the biopsies done today.

"In the meantime, I will call the Sponsor and make certain they are aware of this new development and that they are going to agree to pay."

So I find a parking lot to sit in and I try calling the dermatology place. I get a big run around about how she's only an operator and that I need to know a name or an extension. Luckily I remembered the doctor's name. I get put through and get voice mail.

I leave a big long message about how I need to have the biopsies done STAT and that I can turn around and drive back right now (which, in hind sight is what I should have done) and here's all the ways to get a hold of Research and they will verify that Novartis is going to fork over the payment.

I never got a call and neither did the trial coordinator. She called me at 4pm to say that she has been trying all day to get through and keeps getting a busy signal. If not a busy signal then a message saying "we're sorry, all circuits are busy at this time, please try your call later." What the heck?

I spend the rest of the day hitting redial on my cell phone trying to get through as well.

I am highly suspicious that the fact that American Idol is holding next season's auditions in downtown Jacksonville has something to do with the phone circuits being overloaded. The thousands of calls to back home saying "they don't know talent when they see it and Simon's a great big JERK, Mom!" are clogging up the phone lines and preventing people who have issues like MS and cancer and research and other things from actually having any meaningful conversations with those who might hold their futures in the balance.

I finally got through, tho. It was 5:10pm. A lady with a really nice voice told me the office was now closed and if this was an emergency to hang up and dial 911. Figures.

So, here we are. Thursday evening and the results of my MRI have never been okay'd by Berlin, so there's no way the Monday ext. phase was going to happen anyhow.

Here's the new clincher tho. Novartis, upon hearing of the biopsies that need to be performed, are now saying that my ability to even continue in this study at all now rests solely upon the results of the biopsies of these three stupid dark dots on my skin that I have had all my life.

If that ends up causing them to take my beloved Fingolimod away from me, head's are going to roll. Starting with the Biopsy Queen, I think.

I'm still shaking with excitement!!

I got the most exciting phone call earlier! It was my trial coordinator. I had called this morning and left her a voice mail asking if she had scheduled my dermatology appointment yet. Of course I was confused about how we left things -- whether I was supposed to call them directly or if she was going to set it up for me. Naturally, I was supposed to call myself. Oh well.

When she called she said she would hang up right then and get it scheduled and call me back.

When she called back she asked how many shots I had left.

"3" was my answer.

"How many pills?" she quizzed.

"Let me go get the bottle and count them, hang on. 25" was my reply.

She said my appointment with the dermatologist is this Thursday at 10:50. Then came the exciting part.

"I was thinking about this and if Berlin says your MRI is good and does not have to be redone, then after your dermatologist appointment everything will be done."

I said "Yes....??"

She said, "Well, then if Berlin says it's okay to move to extension phase, rather than wait until Sept. 3, we can do it next Monday instead."

I paused while it sank in.

"Are you still there, Jeri?" she asked.

"Oh YES! I'm still here! Just trying to believe what I'm hearing. You mean NO MORE SHOTS??!!"

She laughed her beautiful lyrical laugh and it rained over me like a soothing salve. "Yes, that's exactly what that means."

So...I'm not getting my hopes up, but my fingers are crossed, as well was my toes. I'm saying a little prayer that my MRI was good to go. It turns out that it doesn't matter WHAT it shows, just as long as the images were taken according to protocol.

I'm guessing that they were because the MRI technician (after peeling my keys off the tube and taking my dead ATM cards to the locker for me) told me that they were going to take a while because since I was in the clinical trial, they had to be done a certain way. That tells me that she was aware of how she had to do them even if she wasn't aware that my ATM cards should not go in the tube with me. Hopefully she got the important part right.

Thank goodness I took pictures while doing my last shot. I wanted to show a friend of mine how big the needle was.

Here's the last one...hopefully forever:









That's not easy to do one handed. Usually I'm grabbing my thigh and pinching up a big roll so I can trick myself into believing the needle won't come anywhere close to my bone if I do that. Just sticking it in with one hand while watching through the camera I was holding with the other was a really strange experience. It was like watching on TV and I wanted to look away but remembered that I really had to watch if I wanted to do it right. No changing the channel.

So, I hope I'm not speaking too soon and jinxing myself here, but that, folks, might be the last time I ever stuck myself with a needle. Ever.

I'd say "pinch me! I'm dreaming!" but it might feel too much like a shot and scare me.

I'm that person who holds the line up

You've seen the commercial. Everything's moving at the speed of light with customers doing a synchronized dance around the store and smoothly moving through the checkout by swiping their credit card thingie...

I'm the one who makes the music come to a stop and everyone in line has a chain reaction rear-ender accident -- because I'm the one who has to write a check. I almost forgot HOW to write a check since I opened my account 2 years ago and have never even finished the first book of checks because there was no need to write one since I got the debit card for the account, too.

I have no choice. I apologize if you find that I'm in front of you fumbly farting around trying to get to a blank check and looking for a pen. I hate those people and now I are one.

I took my MRI'd debit card to the bank and they gave me the bad news. They got the test results back from the radiologist and my card is DEAD. I was beside myself. He had his whole life ahead of him, my debit card did, but he was struck down in his prime, and there's just no reason why it should be that way. I mourn him terribly.

His Uncle Check Book is living in the olden days and I hate lugging that clunky sucker around. I have to keep hearing his stories about "in my day, before there WERE any ATM contraptions, everyone had to know how to write and carry a pen!" Sheesh!

Anyhow, the people at my bank were beside themselves with hysteria. I told the death by MRI story to one lady and she had to gather all the other bank employees to hear it all over again. It was a slow day at the bank. I was their only customer at the time. Apparently there's not much need for people to go into the bank any more. Seems they are all out swiping their debit cards and never giving a second thought to their magnetic strip that is the single thin line that separates them from living the retro horror story that my life has become. The poor sots in the dark cave-like space of the bank's interior actually seemed starved for outside contact.

I'm really glad that I could serve my fellow citizens by uplifting the spirits of the bank employees and leaving them with a grin on their faces that was equal and opposite to the frown on mine. 7-10 days to replace the card?? Are they serious? I mean, they have that scanny thingie right there on the desk so they can change the pin. Can't they get the dude behind the curtain to give my card a brain again?

Oh well. It's really put a damper on my spending habits because I hate using checks so maybe it's a good thing. I'll have plenty of cash built up in the account when I get the new card and have to go break it in with a mad swiping frenzy.

NOTE TO SELF: Remember NOT to leave cards in pocket at next MRI. (I know it is a stretch to think I will remember this for a year, but maybe the agony of check writing will sufficiently warp my psyche so that I cannot forget).

Don't always believe the MRI technician...

...when she says you are fine from the waist down.

Yesterday, as part of my decathlon grand finale clinical trial VISIT NUMBER 10, I had to have a brain MRI. The tech told me I was fine. Just remove any mouth jewelry (??? like I have any!) and earrings or necklaces or bobby pins, etc. I had none so I was good to go.

Last time I recall the lady saying I needed to remove my underwire bra. This time I asked about it and she said "Nah, that's too far away from where we will be shooting." So it never occured to me to worry about the contents of my jean pockets which are still a good distance from my underwire bra thankfully. Gravity hasn't had it's way with me to that degree ... yet.

She puts me in there and goes out the door to the other side of the glass. Before it ever winds up like a jet taking off and sounds like sneakers in a dryer, I am feeling a tug on my pocket. I pat my pocket and realize my keys have come alive and are trying to make a break for it through the cloth prison of my jeans. I reach inside my pocket and grab them by the fob. Aiding and abetting, I free them from their jean prison so I could show the tech that my keys were escaping.

No sooner were they loose than they made a beeline for freedom, shooting straight up out of my hand. They were caught by the prison guard magnets of the MRI machine and were held securly until the correctional officer MRI technician came rushing in to collar them and escort them to solitary confinement in the locker outside.

She asked if I was holding anything else back like a cell phone or anything. I said "No, but I have these." I reached in my back pocket and pulled out my credit card, my debit card and my driver's license. I waved them around so she was sure to see them and, apparently, so that the magnets could have their way with them.

Tonite I just got back from the grocery store where the ATM machine told me that "Your card cannot be read. Please try another card." Like I have a deck of 52 in my pocket or something. Good thing I took my checkbook with me, and even better that there was money in that account. We get to eat for another day! YAY!

Anyhow, the MRI debacle was the highlight of the show yesterday. The rest was rather mundane. I left the house at 7am and didn't get home until after 7pm. I started out with the Pulmonary Function Test and the tech is the same one I always have. We finished in 20 minutes and he said I was getting better at it because we got done so fast. I told him I'd had lots of practice breathing since the last time I saw him. I told him I even practiced in my sleep.

Then it was across the street to the towers to have bloodwork, EKG, peg test, numbers test, etc. I screwed up the numbers test the same way I always do...I aced the practice with perfection, but sat midway through the 60 number test like a drooling idiot just listening to the guy spout 7's and 9's again.

Then came the EDSS (Expanded Disability Status Scale) testing. The neuro I had was brand new. The one I had the last two times had finally completed his fellowship and had a practice now, but he had trained the new "fellow". As fellows go, he was quite likable and more importantly, very conscientious of his job. Very thorough in every aspect of the test. Only thing is, at the end he actually told me that my score had improved and I'm not sure he's allowed to do that. I don't have a clue what my score is, but it's got to be better than 10 because the fact that I aced the breathing test proves I'm not dead. I just don't know how close to 1 I am.

Then there was the CT, the MRI, the OCT and the eye exam. It all culminated in a 20 second visit with the neuro who swooped in, did a couple neuro-esque moves on me, signed a paper, asked if I wanted to be in the extension, said "Great!" when I said yes, and then flew out the door all in one graceful fluid motion.

I felt like asking if that was a bird or a plane or Super Neuro. As long as it wasn't Under Dog, I'm cool with it.

I signed the paperwork to go into the extension phase without even reading them. It would have been impossible anyhow because my eyes were so dilated from the eye exam that she had to point to the line for me to sign a couple of times because it all blurred together with the surrounding type.

I'm not too concerned because I already know someone died and someone else was in a coma. I still pop my little pill every morning knowing that if I didn't I would be a whole lot worse off. I know because I was. They'll take my Fingolimod from me when they pry it from my cold dead hand...hopefully not any time soon, tho.

All in all, I can't say as I have ever experienced quite the whirlwind of exams that I did yesterday. Everything was fast, fast, fast. Everyone was efficient and quick. The eye exam took the longest because she had to squeeze me in between other patients, but whenever she WAS with me it was fast and efficient. It was the 3 hours of waiting that went slow.

I did the 500meter walk of the EDSS in 11 min. which I am told by a certain Chickie is roughly 2 mph or normal walking speed for most people. I'm ecstatic about that!

So everything's looking good except for the bad news about my credit cards being wiped out, and you'll be stuck with my meandering shenanigans for at least another year while I cover the extension phase.

To infinity and beyond!

Grand Finale Time

Cue drum roll please....

We must ask those of you in the audience to give us complete and utter silence as this next feat will take the utmost concentration.

Well, I feel like I've been a circus act since I've been in this trial. Working without a new, tight rope act, but mostly clowning around. I'm not going to see how many people come out of my car when I open the door tho. I have to draw the line somewhere.

The Grand Finale that I speak of is my Visit 10. My one year anniversary, and official end of the clinical trial, is August 20th, so I have been gearing myself up for moving on to the extension phase where there will only be pills and not shots (SQUEEEEE!!!)

I have been counting down and Monday is Shot Day. When I took my shot today, it was #4 in the count down to needle freedom...with 3 left to go.

After I did my shot, the phone rang. It was the study coordinator saying she's scheduling my visit 10 appointments. Due to the large number of tests that have to be done for the Grand Finale, she wanted to know if I'd like to split it into 2 visits or just make it one long day.

Then she told me she had my Pulmonary Function Test scheduled for August 5th at 9am and my eye exam and OCT for 1:30 and 2:30 (that same day) respectively. So if I don't have anything else scheduled that day, AND they get me in on time for my appointments, I will have to leave my house at 7am and not get home until 5:30. I told her to cram a few more tests in for that day since being poked and prodded makes the time go faster than reading magazines in a waiting room.

Then I asked her about Aug. 20th.

"Do I have to come in on that very day since it's my 1 year anniversary date."
"No. The tests that we are scheduling for the 5th and whichever other day I can get the remainder of your tests on will complete your Visit 10."

She said that my MRI films and other test results will be sent to Berlin (huh? I didn't bother asking why) and that with Novartis' approval I may end up entering the extension phase a few weeks early.

It took a few beats. Sometimes I'm not so quick on the uptake.

When it hit me I squealed in the poor lady's ear.

"YIPEE!!!! You mean I may not have to take the rest of these shots?? Next week's might be my last one??!!"

She laughed at my enthusiasm and said "Yes, that it correct."

I'm one happy camper.

Staying true to hypochodriacal form, however, my next question was this:

"Hypothetically speaking, IF I were on Fingolimod now, when I enter the extension phase is there a chance they will change my dosage? Or will they keep me on whatever I have been on, IF I've been on it?"

She knows what a worrier I am and knew what I was thinking...I'm going to freak out.

"You will remain on whatever dose you have been on for the last year, or you will begin Fingolimod for the first time. We don't know which. BUT, IF you were on it all along, the dose you will be on in the extension phase will be the same."

She knows how to calm me down, bless her heart. I wonder if the other patients have been such wussies.

So, today I celebrate! Maybe I'll have Dairy Queen for dessert tonite. I deserve it. Plus, I want it and have been waiting for a good reason. Looks like as good a one as any.

So far, to date, I have missed only 2 pills (both times I was out of town with my mother and sister when I remembered) and no shots. I can't say I was ever that good about remembering my shot when I was on Copaxone.

But I have a routine. I take the pill at 9am rain or shine. 9am has become ingrained on my brain as a time when I should suddenly freak out that there's something I should be doing. When I realize 9=Fingolimod, I take my pill and (almost) never forget. The results I've gotten are a added plus that helps me remember.

I wake up every morning knowing MS is with me. And then I take my pill, and then I say a silent prayer that I have been one of the fortunate ones who has done well in this trial and been able to live a relapse-free life for 14 (or 15, I lost track) months now. I am truly blessed.

So this concludes my show for now, hope you found it entertaining.

I'll post back when I go for the visit 10 appointments as I sure there will be some fiasco that I could spin into a funny tale for you. Got to keep you all entertained.

And we still have the extension phase. :-)