Nearing the end

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

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

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

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

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

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

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

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

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

New Drug Appears To Overcome Resistance In Ovarian Cancer

New Drug Appears To Overcome Resistance In Ovarian Cancer

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

Apparently it was just MS fatigue

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

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

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

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

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

Update on the Estradiol experiment

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

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

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

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

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

The Estradiol Experiment Continues

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

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

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

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

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

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

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

Blood Pressure Medicine and MS

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

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

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

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

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

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

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

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

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

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

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

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

Estradiol update

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

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

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

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

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

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

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

Vote Now to Help Fund Research for CCSVI and LDN

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

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

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

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

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

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




So please take a moment and vote today!

http://www.refresheverything.com/neurologique

Estradiol and possible fatigue

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Doxycycline and MS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Or will the price drop? Ha!

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

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

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

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

Taking a deep breath...

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

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

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

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

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

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

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

Also at their website is a pdf of the:

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

HIGHLIGHTS OF PRESCRIBING INFORMATION FOR GILENYA

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

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

Gilenya to cost $48000 per year!!

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

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)

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!

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

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

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

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

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

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

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??

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

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...

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

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

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

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?

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!

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...

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

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

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

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

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. :-)