Too old for Gilenya?

In the Gilenya Facebook page we recently had a discussion about this article: Meta-analysis of the Age-Dependent Efficacy of Multiple Sclerosis Treatments
 
A meta-analysis in scientific thinking is a review of multiple previous studies to try and confirm a new hypothesis. In this case, whether the efficacy of MS drugs declines with the age of the patient and finally becomes ineffective.
 
MS Drugs
 
Drugs approved for MS are not drugs that can cure the disease. Nothing can cure the disease. We still don’t even know what causes it.
 
So the drugs approved for MS are basically drugs to halt progression of the disease. (And like I said, the cause of which is still unknown, so what halts the progression is still technically unknown.)
 
At this point there are so many DMT drugs for MS (17 to date) that attempt to work in many different ways. It can be a crapshoot.
 
But this article concludes that all DMT drugs that work on MS begin to decrease in efficacy after the age of 53. I wonder if this is why my doctor keeps asking me how old I am?
 
Are expensive
 
MS drugs, especially in this country, are exceedingly expensive. Not to mention the hundreds of others that aim to treat symptoms.
 
In one example, in 2004 the MS Society estimated that “the major drugs approved by the Food and Drug Administration (FDA) for relapsing- remitting MS can cost between $10,000 and $14,000 a year.”
 
Given the news that the cost of prescription drugs in the U.S. is now the highest in the world. Can you imagine what our costs are today?
 
And are difficult to measure
 
And speaking as someone who now has entered the secondary progressive phase of the disease without active exacerbations, it is often hard to tell if the drug I’m taking makes a difference.
 
The only really accurate test we have is the MRI, which can show If there are newer lesions. The idea is that if there are newer lesions the drug that you’re taking is probably not working as its goal is to keep new lesions from forming.
 
But there have been no tests that show that new lesions have any correlation with symptoms. So does the appearance of new lesions on the MRI mean that the disease itself is advancing? Has being on this drug made any difference.
 
What I’m wondering
 
So here’s my dilemma. I have continued to decline over my lifetime.
 
And it is concerning to me that I keep paying x number of dollars to stay on this drug all while studies are showing that stopping it now might not hurt me.
 
On the other hand, other studies show that some people who stop it, even those that switch to something else, experience a major rebound exacerbation resulting in further decline from which I cannot recover.
 
And there is no way to tell in advance how I will respond.
 
Ergo, if I stop the drug based on these latest studies, I will never be able to get back to where I am now if I decline further after doing it.
 
I will be meeting with my neurologist next week and having a chat about this. Stay tuned.
 
Things I’ve learned this week
  • Nasturtium leaves, flowers and pods are all edible
  • Lede is a real word, as in “Way to bury the lede, Amy!” Apparently that’s the noun! I’ve been imagining that phrase wrong.
  • Weight-bearing describes a person who is able to carry their own weight with at least one leg
  • Three inputs to your brain for balance: sight, auditory (vestibular), and proprioception, which is the medical term that describes the ability to sense the orientation of your body in your environment
  • Maybe a picky eater is actually only picky about the method by which the food is prepared
  • Inspiration porn example: ‘He asked her to the prom even though she has Down’s syndrome.’ But should be just like it’s not cool if you say ‘He asked her to the prom even though she is Asian.’
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Lightbulb. Skin is an organ

 
I have never really taken care of my skin. I never got acne, just the occasional pimple. I washed my face at least once a day with Phisoderm or Cetaphil, gentle cleansers.
 
I didn’t moisturize regularly, and applied sunscreen only when I planned to spend the day out doing some activity, like skiing or going to the beach. 
 
But this article made me think about my skin as an organ. According to researchers, it is our largest organ, roughly 8 pounds (3.6 kilograms) and 22 square feet (2 square meters).
 
Could it be affecting or partially responsible for my MS? How could it not?
 
Medline
 
I poked around in the National Library of Medicine’s  PubMed* search: [(skin[Text Word]) AND multiple sclerosis[MeSH Terms]], but didn’t see anything relevant. Mind you, I’m not a scientist or expert in medicine. Caveat Emptor! 
 
*PubMed comprises more than 29 million citations for biomedical literature from MEDLINE, life science journals, and online books.
 
 
I did see at lot of discussion about MS and sympathetic skin response (SSR) as diagnostic test. The SSR test measures whether the sympathetic nerves of the skin are working.
 
Apparently in a lot of MSers, the response is absent in one or both limbs, for example. In healthy subjects the response is always there. This is interesting, but not something I think I could fix!
 
Google search
 
Next I tried an internet search. Again I found nothing MS specific, although there are some warnings on various drugs about possible skin cancer. Meaning that some subjects began showing skin cancer during or after the trial.
 
There is no way to tell if the skin cancer was already “on board” before the trial started. Or if the drug made them more sensitive to the sun.
 
 
So there is some involvement there!
 
Ergo
 
Yet again I find interesting (to me) information, but nothing conclusive. Just a vague hypothesis: I think I should be taking care of my skin better.  But who knows what that means?
 
For now, I will just accept prevailing theory until proven otherwise. So I resolve to craft a regular, daily, non-negotiable skin care routine, something like this:
  1. Wash my face once a day, every night. Don’t over wash and risk drying out the skin, causing it to produce more oil.
  2. Shower, wash hair at least once a week. Gross I know, I used to shower daily but it’s hard now. Plus I read this and this
  3. Wash my feet every night before bed, slather with lotion
  4. Slather body lotion daily – moisturize, moisturize, moisturize
  5. Use sunscreen daily or at least before venturing outside anywhere
  6. Ask your GP to include a regular skin cancer check in your annual, or see a dermatologist. Some doctors recommend every year!
  7. Drink lots of water
All this is based on my gut feeling about the right thing to do for me. Your results may vary! 🙂
 
Other stuff
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MS and hot cocoa

Hey, did you read the article that hot cocoa made with high-flavonoid chocolate could ease MS fatigue? I have MS fatigue. I like cocoa. This sounds like a recipe for an informal experiment!
 
The headline of the article I read is Daily Cup of Flavonoid-rich Cocoa May Help Ease MS Fatigue. It details a small trial of 40 MSers, half daily drinking high-flavonoid cocoa made with rice-milk and half drinking low-flavonoid cocoa. (Was the choice of rice-milk just a nod to food allergies?)
 
Fatigue was measured by a quality-of-life self-report, and fatigability was measured by a six-minute walk test (i.e., how far could a user walk in six minutes).
 
The trial concluded that the high-flavonoid cocoa was not only linked to heart and gut health but may “improve fatigue and fatigability” in MS.
 
What is a Flavanoid?
 
They are a type of plant-based antioxidant that occurs naturally in fruits, vegetables, wine, and tea, and are responsible for the vivid colors found in produce, for example. Studies have suggested that flavonoids have anti-inflammatory and neuroprotective benefits.
 
One place they are found is in cocoa beans. Usually the cacao tree produces the beans that are then roasted and ground into a paste called the cocoa solids. 
 
Thus, cocoa solids are a good source of flavonoids and the percentage of solids in the product should be listed on the side of a package. You can use this number as a general guide for choosing chocolate made with the highest concentration of solids. 
 
Unsweetened cocoa powder has 88 to 96 percent cocoa solids, for example. Dark chocolate contains 45 to 80 percent, and milk chocolate has only 5 to 7 percent, as the solids are “watered down” with sugar and milk. White chocolate doesn’t contain any.
 
(Was low-flavonoid cocoa achieved by replacing solids with “artificial flavors”?)
 
What about Heat?
 
As cozy as a cup of hot dark chocolate cocoa before bed sounds, it probably isn’t the optimal way to get your flavonoids. According to researchers, boiling causes the highest loss of antioxidants in vegetables, for example.
 
The length of time you expose foods to heat can significantly impact the antioxidant content. 
 
And imagine the roasting process by which the cocoa bean is converted to a cocoa solid. Although roasting is considered a “dry cooking method” and one of the best ways to retain nutrients, it may be reducing antioxident content by as much as 60%.
 
This shouldn’t matter much to us, as the cocoa we buy in the stores has the solids number on the label. But then again, researchers have discovered in some studies that the labeled cocoa content of the chocolate did not always reflect analyzed levels of flavonoids. Sigh.
 
Bottom line
 
This was a small study; more research is needed of course. But it seems like a thing that would definitely qualify for a go.fund.me effort. Hot cocoa is pretty much universally liked.
 
If you don’t like dark-chocolate cocoa, a square from a dark chocolate bar upon waking seems like it would help. If you want a higher flavonoid count, try making your own cocoa with unsweetened cocoa powder.
 
Maybe it is just a quality-of-life thing. Having a cup of cocoa every day makes you happy. We deserve that. 
 
And even if you only drink milk-chocolate cocoa, as long as there are some solids in it, you are getting a few flavonoids. 🙂
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Genial Gilenya

I am now taking the oral medication Gilenya (fingolimod). It was first synthesized in Japan in 1992 by chemical manipulation of a naturally occurring antibiotic, and finally approved by the FDA in 2010 as “the world’s first oral MS drug“. 
 
I call it genial because compared to giving myself daily shots, it is just a daily pill I swallow. But “genial” by no means suggests benign. This drug is as toxic as everything else I have tried. Incidences of PML occurring in people taking Gilenya do happen.
 
This Method
 
Everyone’s immune system contains lymph nodes, which are tiny glands containing immune cells (AKA white blood cells) called lymphocytes. Lymphocytes are usually helpful, but in MS they get confused and attack the central nervous system (CNS), and permanently damage the myelin sheath.
 
Gilenya activates sensors on your lymph nodes to restrain some white blood cells. That way, these blood cells aren’t released into the bloodstream, where they can attack. (Other lymphocytes are still circulating and available to do their job, watching out for intruders like viruses and bacteria.)
 
It also activates sensors on your heart, which can cause your heart rate to temporarily slow down. So it is recommended that all users be monitored by a medical professional for at least six hours after the first dose.
 
My Experience
 
I have been taking Gilenya since April 2012. This is from an earlier blog post:
 
…I packed my backpack with items to stave off the boredom of sitting around that long: two books I am currently reading [one fiction and one non-fiction], a book of Sudoku puzzles [I’m addicted!], lip balm…
 
We also brought a cooler with yogurt, granola bars, and sandwiches.  [My husband] brought a fingertip pulse oximeter so I could check my pulse regularly on my own.
 
In the end, the whole experience was pretty anti-climactic, which is probably the best-case scenario, really.  I read one book the entire time, and they let us leave before the rush hour started.
 
It was a record heat in SF, which lent the whole outing a surreal feel, and now that I’m onto Day Five, it is like it never happened…
 
It’s now been 6 years and I have tolerated it fine, but it has not made any amazing difference, as I had secretly wished. 
 
Things I’ve Learned
 
Gilenya might increase your risk of skin cancer. It can render a “live” vaccine inert while using it. And it can interact with a multitude of drugs, including vitamins, and herbal products.
 
It is rare but macular edema (a correctable eye condition causing swelling and blurry vision) may occur within the first 3-4 months of starting. It may be confused with an MS exacerbation, so check with your doctor, and consider annual ophthalmology appointments.
 
Finally, I have started to see reports about a “rebound relapse” phenomenon when users go off it. Obviously, once you go off, you should expect that the “door” of all lymph nodes is no longer being guarded so you most likely will resume MS where you left off.
 
But in about 25% of patients, there is an even more aggressive worsening of MS after stopping and these patients “do not return to the level of function that they had before or during treatment“. This worsening most often happens within 12 weeks of stopping. It is definitely something to consider before you start if you think you will want to go off it to get pregnant, for example.
 
Other stuff

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Caustic Copaxone

My liver toxicity from Avonex meant that I couldn’t take anything else with interferon, ruling out all other MS drugs at the time, except for one: Copaxone.
 
Copolymer-1, as the chemical was originally called, was discovered by scientists in the 1960s in Israel. Again, I don’t know what they were looking for, but they discovered that it suppressed MS-like disease in mouse models.
 
[As an aside, this is called Experimental Autoimmune Encephalomyelitis (EAE), still accepted today as a murine model for this disease. Interesting because MS doesn’t seem to appear in the animal kingdom, or maybe their lives are just too short to foster development of a slow-progressing disease like this. So scientists needed an animal model to study and use in tests. But we still don’t know what causes human MS, so the thing researchers use to induce it in animals may sometimes cause unintended consequences hard to tease out (i.e., was our result due to the mechanism of the disease itself or a reaction to the variable, which is not found in human subjects?) Something to make you go “hmmm”. ]
 
Drug development continued and it was finally approved for the Relapsing-Remitting form of MS (RRMS) in 1996.
 
How It May Work
 
Now known as glatiramer acetate (brand name Copaxone), it is a synthetic (man-made) protein that mimics a component of the myelin sheath and seems to block damaging cells, though the process is still not understood.
 
Some researchers believe that it acts as faux material to lure and distract the attacking cells away from their real target, but others believe it actually alters the body’s immune function itself.  Concerns about this persist but there is no evidence yet to prove it.
 
Anyway, my neuro switched me to this. I administered myself sub-cutaneous shots of 20mg daily for 7 years, from June 2003 until July 2010.
 
More recently the FDA has approved a newer 40mg dose injected only 3 times a week, and there are some reports that those taking the higher dose less often have fewer side effects. But the lower dose and schedule are still used as well.  
 
Ugh
 
I’m not sure if I would’ve welcomed news of a less frequent dosing option. I hated the shot I took everyday, and I doubt a higher dosage less often would’ve made that much difference. 
 
I rotated injection spots on my body as I was instructed, but no matter where I shot, it felt like I was injecting acid. 
 
For the first few years, I tried to dutifully apply ice packs to the area, both before and after it, as I was told, but it always seemed to make it worse.
 
Finally one day I tried heat instead. Ahhh, the relief!
 
Who’s In Charge Here?
 
Wanting to check that I wasn’t harming things, I called the helpline. But the nurse on the other end told me that she hadn’t received any information ether way. But as far as she understood it, it wasn’t affected by heat.
 
We decided that if a heating pad worked for me, I could continue doing it until I heard otherwise.
 
And as I was looking over new prescribing documents about this drug, I found this: “Before use, allow the solution to warm to room temperature.” Doh! Why didn’t I think of that?
 
Helpful tip: Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist whenever you get a new medicine.
 
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MS or gout

In 1997 I came across a tidbit that I thought was funny. It turns out that MS and gout are mutually exclusive, meaning that if you get one you likely don’t get the other and vice versa.
 
I’d love to know what researchers were looking for when they found that out! But there it is. We are lucky I guess. Although I suppose if I was able to choose I would choose gout. 
 
I understand the pain is excruciating, but it can be treated with medication. Even without treatment you could recover within 1 to 2 weeks.
 
Also it affects men more than women. Interesting because according to NMSS, MS affects at least two to three times more women than men.
 
What Cases It?
 
Gout is caused by an overabundance of uric acid (UA) in the blood.  This may be brought on by genetic factors, or by “what was once characterized as a “rich man’s diet” (high amounts of meat, seafood, alcohol and sweetened drinks)”.
 
It is produced by the body and is the main component of urine in both humans and primates. Normally, it is excreted from the body via the kidneys in the urine. But when UA backs up, causing high levels in the blood, it forms crystals in the joints which results in gout.
 
But these same high UA levels also appear to prevent the development of MS leading to my question: which came first? Does MS prevent us from getting gout? Or does getting gout prevent a person from getting MS? 
 
How Can Knowing This Help Us?
 
Researchers now know that UA acts as a “free radical” scavenger in the body.  For example, as part of basic daily processing, any body produces “highly reactive” molecules that create inflammation and damage nerve fibers. UA acts as an antioxidant and just “mops them up”.
 
It also has been shown in animal models of MS to reduce inflammatory flare-ups in the brain and slow the passage of inflammatory cells into the central nervous system.  It even prevented paralysis in mice. Unfortunately not in humans.
 
Another recent study found that lower UA was associated with disability progression, as well as cognitive decline. 
 
Even more recently, another study found that “UA levels declined during the course of MS, which suggested that the periodic flare-ups of inflammation that occur in MS may ultimately exhaust the body’s antioxidant reserves.”
 
So I assume then that keeping UA levels up is a good thing for MSers as well as supporting my antioxidant levels. I will add the forbidden-for-gout foods to my diet to increase my levels of UA. See list here.
 
Where To Next?
 
 
That leads to another question I have: since animals generally don’t produce UA because they have an enzyme that breaks it down, we have to artificially induce it in them. So doesn’t this enzyme skew the test results? 
 
Also would UA protect you from getting worse if you already had it? Because right now there is very little that can be done for those of us that have transitioned to secondary-progressive (SPMS).
 
Obviously I’m not a scientist. But clearly, I think the relationship between UA and brain inflammation should continue to interest scientists.
 
I pledge to bring it up at my next neurologist appt. at least.
 
Other stuff
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1M U.S. MSers

I had never heard of it when I first got told of my probable-diagnosis, but once I was told it was probably MS and I mentioned it to other people, almost everybody replied that someone else they knew also had it.
 
So I wondered how many others in the country were also dealing with this disease? How big was my tribe?
 
I called the National MS Society (at that time the WWW was still in its infancy) and got the same answer that they had been giving for years: that there were approx. 400,000 people in the US living with it.
 
I knew that wasn’t correct since everybody seemed to know at least someone afflicted with this disease.
 
I demanded to know what benefit the Society had in keeping the number reported so low? Did it mean the disease was considered an ‘orphan disease,’ eligible for money and tax breaks? No answer.
 
Why it matters
 
Turns out, according to the MS Society today, this 400,000 number was just an estimation based on population growth. In fact, “(i)n the United States, there has not been a scientifically sound, national study of prevalence since 1975.
 
Since the U.S. government never required MS incidence (number of people NEWLY diagnosed) or MS prevalence (number of people currently living with it) be reported or followed, the MS Society and others just estimate.  
 
To be fair, I do recognize the difficulty counting incidence of a disease in which there is no definitive criteria for diagnosis.
 
But it is said that “Society expects epidemiology to accurately document our health.” Difficult or not.
 
Studying MS leads to understanding its impact on people’s lives, their finances, and the healthcare and services people with MS need. Keeping an accurate count of us should underscore the extent of economic burden to our society.
 
It could also help scientists know if MS is spreading, and if there are MS clusters that hint at factors that may trigger MS.
 
New numbers
 
Since the government has shown little interest, the Society finally decided to do it for themselves and launched the MS Prevalence Initiative to determine a better way to determine a “scientifically sound and economically feasible” estimate of the number of MSers in the U.S.
 
They went on to explain that they are now using new and improved measurements because it had been so hard to count before. 
 
And I was both pleased and dismayed when I saw a new notice that a recent study more accurately showed that close to 1 million people in the country have this disease, more than twice the number they had been using.
 
They also noted that “the dramatic jump seen in prevalence has more to do with methodology than an actual rise in the number of MS cases” though they don’t discount that possibility. Sigh.
 
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MS and the DMTs

In 1991 when I was first diagnosed, I was told there was no treatment, nothing even recommended. I was told to just go home and though it may never get this bad, to make plans for a being in a wheelchair.
 
So I squirreled away old shoes I would wear when in a wheelchair to demonstrate to others that I use to walk, that I was still in their club. And I signed up for motorcycle lessons.
 
Then the first “MS drug” —Betaseron— was approved by the FDA in 1993. But everyone was quick to remind us it was not a cure. Nothing yet could halt  progression. The drug could only slow it.
 
Do I Start?
 
So began the advance of the “modern” age of MS medication and the word “immunosuppressant.” Yes, while everyone else works to boost their immune system, ours is out of control, attacking the nerves in our brain and spinal cord.  
 
(There are now more than 15 drugs, sometimes called disease-modifying therapies or treatments, DMTs. See chart here.) 
 
But it was still new, my doc at the time never even mentioned it, and I thought giving myself a shot was such an extreme, big deal since I didn’t have any symptoms. So I assumed I could wait to see if I got any. 
 
Big regret. Once I started having symptoms, and started giving myself shots, it was apparently too late. The disease had silently progressed while I “was busy making other plans.” (John Lennon, Beautiful Boy)
 
I will always wonder if I would’ve started sooner, would I still be able to  walk?
 
Why start them?
 
Evidence now says you should start disease-modifying drugs as soon as possible. I concur. What I learned is that you can never have a do-over in disease.
 
Often when you are first diagnosed, you decide you can treat it with alternatives to Western medicine. By changing your diet or taking herbal supplements, maybe. 
 
And when you do, you feel better.  It can’t just be placebo, can it? But you are forgetting two things. 
 
One, you were most likely diagnosed with Relapsing-Remitting MS (RRMS), so while your doctor was determining what was causing whatever you went to her for, you probably went back into remission all on your own.
 
And two, it’s a neurological disease. Because you now have been told it’s probably RRMS, you will never again be able to judge your disease by how you are feeling.
 
Why stay on them?
 
Yes, these drugs are so expensive and generics are hard to come by. You may fear that drug companies are just being greedy. The news reports all the time about shady practices and all kinds of fraud.
 
But it’s your life. You may be able to get financial assistance from the drug companies, or even the MS societies. You must now recognize that you’re on an expensive journey not of your choosing.
 
You must trust your healthcare professionals, or find new ones, since you can’t necessarily tell if it is doing anything. And I’m not suggesting that you give up any alternatives you believe are helping too. Obviously ask your doctor first.
 
Please just know that if you stop to see if you will feel worse, you can’t just resume and get back to where you were.
 
Related Stuff
-Added 2/20/2020-
Things I learned recently
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From my dad’s daughter

I love you, Dad! Happy Father’s Day and thanks for everything.


image from lorna.typepad.comI believe that what we become depends on what our fathers teach us at odd moments, when they aren’t trying to teach us.”
 
– Umberto Eco
 
Dear Dad,
 
As the quote above says, I have become who I am partly because of how you and mom raised me, and also by what you have taught me by example. More than just contributing your genes, you shaped me.  I learned that I was safe in my surroundings, how to be a companion, what to look for in a spouse.
 
In our family, you are the “thinker and planner,” the gentle intellectual.  Some of the things I got from you were an understanding of how finances work, an interest in researching, and, apparently, your ability to make friends: mom reports that you know all the others on your morning hiking trail by name.  This has been one of the delights of my life–thank you for that!
 
Some of my fondest memories include going on a test date together to learn how to expect to be treated, flying to visit colleges with you, going on the family trip to Hawaii and another time renting a beach house in Sea Ranch, sitting quietly (comfortingly) with you in a car dealership as I was nursing a broken heart, convincing you to help me buy my house (“if this is a mistake, let me make it”), then helping me replace a broken sewer pipe in it when I had no money left to pay a plumber.
 
As recently as the 70s, fathers were viewed like second class citizens.  I’m sorry if I made you feel like that.  I have always known that you would be my safety net, helping me navigate my life if I needed it.  I see my brother with his son and am charmed by their relationship and know that he learned how to be a father from you.
 
I can only imagine what it is like to raise a head-strong child like me, imagining what that life would be like, then watch as illness takes over and feel helpless to do anything about it.  But I learned from both of you how to be flexible and always to have humor.  Please know that I know we are all just doing the best we can.
 
I love you, Dad! Happy Father’s Day and thanks for everything.

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Hello? MS is still here

It’s March 2018. MS is still here. So I’m introducing it again in case you all forgot.

image from lorna.typepad.com

It's March 2018. MS is still here. And it still sucks. Like a vacuum hoovering away abilities. So I'm introducing it again in case you need a refresher.

Because March is recognized since 2003 as MS Awareness Month. It's orange bracelets and orange ribbons and proud walkers and swimmers as fundraisers.

But MS has been around since at least the 1860's. You can read about the history here.

And while the MS Society says that there are 400,000 people diagnosed with it in the US, everyone knows at least someone who has it. I think it was Montel Williams says it should be 1 million or more.

And that's just in the US. It is estimated to be 2.3 million worldwide.

Organizations

At this point, there are multiple MS associations in the U.S. alone that have information on the disease. Any would be pleased to take donations.

For research there's the Consortium of Multiple Sclerosis Centers (CMSC), The North American Research Committee on Multiple Sclerosis (NARCOMS)  and Americas Committee for Treatment and Research in Multiple Sclerosis (ATRIMS) to name a few.

I guess my point is that there are a lot of eyes on it, whether you are aware or not.

Why Donate

There's a good article demonstrating how to research charitable contributions here. Suffice it to say, there are better organizations than others, even better chapters of the same organization.

Bottom line is that this disease still needs more research. It has proven to be a troublesome, perplexing, messy puzzle. 

And that research costs money.

So wear orange. Wave flags. And remind everyone you know: March is MS Awareness Month, but you can find reasons to give everyday. 

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