June 11th, 2010
02:23 PM ET

FDA panel urges OK of first oral MS drug

By Georgiann Caruso
CNN Medical Associate Producer

An FDA advisory committee on Thursday recommended approval of the first oral treatment for relapsing forms of multiple sclerosis.

The decision paves the way for final FDA approval of  FTY720 or fingolimod before the end of September as a first-line choice for the treatment of relapsing forms of multiple sclerosis.

The drug would complement other long-term therapies on the market, all which aim to modify the course of the chronic neurological disease, and all which involve a needle or injection.  Fingolimod reduces the relapse rate by about half, according to studies early this year in the New England Journal of Medicine.

Fingolimod is taken in capsule form once a day, and if further trials are successful, its use could be extended to people with the primary progressive form of the disease.

In multiple sclerosis, the nerve cells’ protective outer lining becomes damaged, disrupting signals that control muscles.  The cause is unknown, but it’s believed to be an autoimmune disease, which means the patient’s own immune system turns on itself.  This new drug works by preventing the release of white blood cells, so the nerve linings can’t be attacked.  Unfortunately, that can leave the body vulnerable to infection and cancer.

Two studies published in the New England Journal of Medicine in February point out that some serious side effects have been linked to this new MS drug.  One study cited concerns including  infections, cardiovascular effects,  swelling of the retina and elevated liver-enzyme levels.  The other study noted slow heart rate, retinal swelling, infections, and possibly cancers.  An editorial in the same journal pointed out that the rate of herpes infections among patients receiving the 1.25-mg dose of the drug was 5.5 percent; two patients died.

"The risk of infections of any kind is the main side effect we worry about with this drug," says Dr. Loren Rolak, an MS expert from the Marshfield Clinic in Wisconsin and a spokesman for the National MS Society.

But Rolak, who was not involved in the development of the drug, tells CNN he’s still excited about the prospect of this new drug being approved.  “At last, we can treat a whole lot of MS people that we've not been able to treat before."

For people with a phobia of needles, people who don't respond to the current treatments, those who are just plain tired of needle sticks or people who cannot handle the side effects of the existing drugs, including flu-like symptoms or bruising, fingolimod would provide another choice.  Rolak said new patients may be very interested in fingolimod because they’re taking a pill, rather than giving themselves an injection and because overall he says the drug “does seem to be safe and well-tolerated.”

"It's really going to be different for each individual patient. I certainly do have patients being treated with one of our current drugs. They are doing very well, and because it's clearly working for them, I plan not to switch them," he said.

The FDA advisory panel did recommend that if the FDA does approve fingolimod, it should also require “a post-marketing study that would proactively gather information about adverse events and longer-term safety.”

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soundoff (102 Responses)
  1. Hoss

    To Clara: My best friend's mother has MS. After she divorced her husband, she started using marijuana experimentally that her son/my friend procured for her... I have SEEN her walk with my own two eye after using marijuana (notice I say using, not smoking, as she uses a vaporizer which eliminates nearly all of the health risks associated with smoking).... This is a woman that has been wheelchair-bound for over a decade. Without marijuana, she can stand up using her arms for support and perform simple exercises. But with cannabis, she can walk around the house with the aid of a walker. I'm not saying it will work for everyone, but there are methods of using it that are just as safe if not MORESO than the prescription drugs currently on the market... and for many MS patients, it works absolute wonders.

    June 12, 2010 at 00:47 | Report abuse | Reply
  2. C.B

    400,000 and counting diagnosed– horse hockey! That is the same number I was given more than 8 years ago. You are telling me that no new patients have been diagnosed- I know better than that. There is really no telling how many people have MS since many doctors seem to have difficulty diagnosing it in the first place. I got really lucky since my doctor pointed me to the CT Scan/MRI during my first attack- I was two months past my 29th birthday. My sister has had doctor after doctor chasing around ghosts for her issues since she was 28- more than almost 20 years of her life now and still no answers! I have been blessed to have a lot of remarkable people cross my path, and so far I haven't had any burden placed upon me that I haven't been able to carry. My RRMS looks to everyone on the outside like I am doing fine, and I am very grateful for that, no one needs to know any differently but me. My neurologist won't put me on this until she sees more results, but it is encouraging to see that we have the first oral medicine approved. It wasn't looking very good on having one when I was diagnosed. Now if they could just do something about the fatigue I – most of us with MS, I should say- might get the life I/we once had back. They have come along way since 1993, but we all know there is farther still to go. Still I will take all the silver in the cloud's lining I can have!

    June 12, 2010 at 01:02 | Report abuse | Reply
  3. H1N1

    Jerry – I use cannabis on a nearly daily basis, and I work 40 hours a week and am halfway to my post-graduate education at age 23. Just because pot makes you a moron does not mean that's how it is for everyone. Our last three presidents used cannabis, as well as multimillionaire Virgin CEO Richard Branson and late astrophysicist Carl Sagan. You're just prejudiced because you haven't interacted with marijuana in decades and all you hear of it is what Freevibe tells you.

    June 12, 2010 at 01:05 | Report abuse | Reply
  4. KJG

    Spouse of MS sufferer: I am one of the study participants, and I have yet to die from a cold. Yes, it sucks that I am immunosuppressed, and I have to be more cautious than the average person, but if your white blood cell count gets too low, the docs take you off the meds until the count goes back up. Of course I would prefer a med that better targets the exact cells that need to be targeted, but let's be glad that we are seeing advances in treating MS. Saying people will die from a cold is, at best, misinformation.

    June 12, 2010 at 01:45 | Report abuse | Reply
  5. hdgoell

    As an MS patient I was looking forward to this when I first heard about it. But suppressing my WBC is kind of scary. My neurologist and I both agreed that it would be best to let others test this rather than being one of the first in line. Especially since I went from 55 lesions to 1 in 12 a month span using Copaxone. Yeah I get tired of the needles and rotating injection sites with soreness in muscles. But 55 lesions to 1 in 12 months, I won't mess with that suppression rate until I see how others do on the oral drug. I hope for the best, just worry about sacrificing white blood cells to help with infections and cancer.

    June 12, 2010 at 01:47 | Report abuse | Reply
  6. hdgoell

    TO THE CANNABIS DEBATERS: I had a major attack last year with lasting nerve damage. I have taken vicodin, morphine, percocet, gabapentin, lyrica, cymbalta and tricyclic antidepressants and as of two months ago, POT. Yes, it totally helps with the nerve pain and with sleeping. I have smoked pot for recreation and have no problems with anyone who does as I see it way safer than alcohol. It is also a multi billion dollar a year taxable income stream untapped. But yes, I have had the most success with the lasting, electrical shock like nerve pain with marijuana. If anyone wants to keep it illegal, remember this... if it weren't for the Great depression, it wouldn't be illegal. But the southwest needed away to get jobs for whites and the government made it illegal to get rid of Mexicans. Also Annheiser Busch lobbied what would be billions in todays money to make it illegal to regain revenue lost during prohibition when pot started becoming fashionable. People weren't allowed to drink, but they could smoke.

    Marijuana works for nerve pain and I was a skeptic who had no problems with pot or people who smoke it. Plus, how many people have you ever heard of that died from smoking to much pot versus alcohol poisoning? In my 37 years on this mortal coil, the answer is zero.

    June 12, 2010 at 02:11 | Report abuse | Reply
  7. hdgoell

    @SAM.......ask any doctor SAM... you could smoke anywhere from 1 to 4 cigarettes a day, and never see any damage in your entire life. Check your facts. ask your doctor. Smoking is bad yes, but smoking a few isn't deadly. Smoking a pack is. How do you explain people who die of lung cancer that have never smoked in their lives? The chemicals in diet sodas cause more cancer than smoking one to four cigarettes a day.

    @CLARA... no, pot is not a cure all for MS. There is no Cure All. But it does help with nerve pain and unless you have had it or tried it.. you don't know what you are talking about., so please, stop. You look like a fool.

    June 12, 2010 at 02:27 | Report abuse | Reply
  8. Mary Smith

    I was diagnosed with relapsing remitting MS a year ago and after looking into it chose not to take the injectables. Although I think options are good and everyone needs to make the choice that's right for them, I'm not interested in this new pill based on what I've read. I'd rather keep my white blood cells, thank you very much.

    Instead of pharmaceuticals, I'm supplementing with Vitamin D. Two recent studies found that boosting vitamin D levels to the high end of normal dramatically cut MS relapses. One of the studies also found that vitamin D changed the immune system profile to a more beneficial one. And there's the fact that the rate of MS is much lower near the equator, where people can get vitamin D from sunlight year round.

    In addition I'm limiting my saturated fat intake to no more than 15 mg per day. There are lots of indications that this may help. For example people with MS with high clorestoral have more disability than those with low cholestoral. And people with MS who have vascular disease have more disability sooner than those without vascular disease. Also people who live in countries with low saturated fat diets have a lower rate of MS. And then there's Dr. Swank's study showing great benefit from a low saturated fat diet for MS.

    This strategy (vitamin D plus low saturated fat diet) seems to be working for me so far, with no side affects.

    And then there's CCSVI on the horizon. Google it, its a form of angioplasty that according to many who have already had the procedure, can actually reverse some symptoms of MS. Its currently in clinical trials in the US, Italy, Kuwait and soon in Canada. There are lots of first-person accounts from people with MS who have had the procedure on youtube.

    Time will tell, but it sure looks like things may be looking up for people with MS!

    June 12, 2010 at 02:28 | Report abuse | Reply
  9. Carolyn

    This is great news, and I will look forward to more detail and more progress. I take every other day injections, and am tired of the bruising; but it seems a small price to pay. But while my medication (Rebif) has side effects just as this oral one does, they don't seem as significant (possible cancer?) and don't pass through the intestinal system. I am willing to continue with injections even at the quoted 30+% reduction in relapse rate. Relapses cause permanent damage.
    PS You're right, Clara..It is possible marijuana may help with symptoms but will do nothing for the physiology of the progression of MS.

    June 12, 2010 at 08:08 | Report abuse | Reply
  10. Abby

    Could this drug possibly help with the treatment of neuromyelitis optica? I currently have a family member suffering from that disease and we are looking for any possible treatment.

    June 12, 2010 at 09:52 | Report abuse | Reply
  11. Dr. Josh

    As a Neurologist who treats many patients with MS, this new medication is exciting and encouraging.
    I caution that we should not forget the lessons learned from Tysabri, which, as a very good treatment, has serious risks and generally should be reserved for people intolerant or refractory to the current well established treatments.
    Fingolimod, for the first several or more years, should be used with caution as a second or third line (after tysabri) only, until we understand more of the long term issues it is bound to have. It should NOT be a first line agent at this time, nor should it be used for anyone successfully treated but "sick" of needles.
    I welcome the valuable tool in our ability to treat MS, the more options the better, and there certainly will be a role for this medication in my practice as it should be in every neurology practice. But with caution. Over time we will learn if it may be safe to use more freely, but if we start treating every patient who doesn't like or want shots with it, there will be a huge number of them and if anything goes awry, like with Tysabri, we could hurt many, many more people than we could ever help.

    June 12, 2010 at 10:04 | Report abuse | Reply
  12. Neal

    Amanda and Clara,

    I'm with both of you, my dad has had MS for 15 years. He hates taking the drugs because he knows they don't work (benefits of being a doctor) so he's been on the Swank Diet for years. If not for the middle age gut he'd be absolutely healthy. It's tough, but the results are so positive doctors refuse to talk about it because expensive meds are not required.

    Do not trust large MS societies; pharm companies support them.

    June 12, 2010 at 12:04 | Report abuse | Reply
  13. ash

    This is great news. I hope and pray we have cure for this disease in the next 10-20 years. kudos to Novartis.

    June 12, 2010 at 12:20 | Report abuse | Reply
  14. DoSomeResearch

    You don't know what you are talking about!.

    DEA Judge Francis Young – “Marijuana, in its natural form, is one of the safest therapeutically active substances known to man.”

    June 12, 2010 at 12:56 | Report abuse | Reply
  15. Laurie

    I'm so happy to see that finally they are getting close to approving an oral medication for MS. However, even though I'm getting extremely tired of injections every other day, I don't think I"ll be running to my doc about this. The side effects are pretty scary if you ask me. I think I'll deal with the flu like symptoms and pop a couple of ibuprofen to deal with that....and leave the oral meds for another time.

    To trade MS for the risk of cancer is not the answer. And infection? I have psuedo exaserbations every time I'm sick with a cold. I think I'd be worse off with the oral medication then I am with the needle stick.

    So, although I'm happy that we are progressing towards oral meds, I will wait until we progress a bit further before I change meds.

    It may work for some, but not me I'm afraid.

    But....GO Novartis!!! Our family thanks you for your efforts.

    June 12, 2010 at 15:29 | Report abuse | Reply
  16. DCH

    Well, it sounds better than all the other RR drug solutions. I will continue what I'm doing – It works for me: Food restrictions and supplementations. WHY does the FDA and pharma not study these very promising solutions? Could it be that they can't patent it?
    I have managed with mega-doses of Vit.D,plus B12, and Evening Primrose Oil, and giving up gluten and dairy, and staying below 15grams of Saturated fat per day, plus Yoga and meditation.
    It's been over 10 years now since MRI, and only have an attack when I stray from my natural program. I will continue on my path.

    June 12, 2010 at 15:52 | Report abuse | Reply
  17. Joyce

    I've had RR MS for more than 25 years. It was relatively dormant for several years. Then in 2004, it reared its ugly head and I participated in a clinical trial for FTY-720 in Canada. It kept my symptoms at bay for about 4 years, then it stopped working for me. I now have RR MS as well as SP MS. After months of agonizing about my options I am now in the middle of a 2 year program of chemo. Side effects (mainly cancer) are more possible with chemo than FTY-720. This oral drug is a great treatment for most people with MS, but I am VERY interested in the Liberation treatment. Let's get moving on this.

    June 12, 2010 at 19:33 | Report abuse | Reply
  18. MS Spouse

    Marijuana isn't a "cure all" but it isn't just "ignorant potheads" that believe in it's ability to help with some patients. My spouses doctor advised it "off the record". It was that or prozac-type meds to relieve the initial emotional pain he was experiencing. It's not meant for all, or to be taken forever. But it CAN be helpful.
    And no, we aren't potheads. Just 2 people grateful to have a short term solution for anxiety and depression after being told he may never walk again.
    After that, we did Betaseron, which is helping.
    Good luck and god bless to ALL MS sufferers!

    June 12, 2010 at 19:45 | Report abuse | Reply
  19. Van

    It seems progress is being made on the pharmaceutical front but not in scientific illness specific based studies on Cannabis. Prohibition of Cannabis for medical case studies is long overdue to end. Jerry is a case in point, his comments are not based in scientific fact but ignorance and prejudice. Not everyone who smokes pot is a pot head just as everyone who drinks is not a drunk. People commenting on here about Cannabis not fully utilized for numerous illnesses and disease are right. Does anyone who has a debilitating illness like M.S. want this kind of negative attention and stereotyping, NO. We smoke marijuana because it helps control our symptoms and suffering just like other drug therapies. The misinformed prohibitionist propaganda spewing voices will end when the government reschedules Cannabis and these folks find the truth that we as medical Marijuana user`s already know.

    June 12, 2010 at 20:01 | Report abuse | Reply
  20. Kaye

    My mother had RR MS. She was dxed in the early 80's and took cytoxin by mouth after a year of iv treatments. It helped her tremendously for about 10 years. However, 10 years later she died from leukemia. Hmmm trading MS for cancer sucked big time!

    I am glad to see there are new things being worked on. But this wouldn't be one I would be willing to try.

    June 12, 2010 at 22:21 | Report abuse | Reply
  21. rob

    My husband was on interferon years ago for about 6 months.It almost killed him.He started taking copaxone 10 years ago and has kept his MS at bay.He still has severe nerve pain a couple of times a week.I wish scientists could discover a cure for that since nerve pain is the worst sympton..We have insurance that covers the cost of His expensive drugs.I feel sorry for those who don't.But everybodies health coverage is just hanging by a thread.

    June 12, 2010 at 22:52 | Report abuse | Reply
  22. Chomsky

    First of all marijuana helps treat the smyptoms but it does nothing to arrest the development of the disease.

    Second, there is a standard protocol to test for and rule out Lyme's disease before MS is officially diagnosed.

    Third, there are no "all natural" treatments to arrest the disease. The closest you can come is the Swank diet, and the research is not conclusive.

    Fourth, people should be cautious of switching from any injectible/IV drug that is helping to an oral medication with such serious side effects. When Tysabri came out in 2006 they had to pull it from the market and change the protocol when they re-released it. Give it a year or two to make sure it is safe. The FDA has approved dangerous drugs before, and they are likely to do it again.

    June 13, 2010 at 00:01 | Report abuse | Reply
  23. Tony


    We can all whine and try to make up facts with no sources, but that's never effective. Next time you should try backing up what you say.


    That is a page that shows a myriad of government studies involving marijuana. Guess what? You're completely wrong.

    Sounds like you really wish you lived in your dream world though.

    You're the ignorant one.

    June 13, 2010 at 02:35 | Report abuse | Reply
  24. Chris

    My brother has been treating ms for 10 years on his own and with some doctor suggestions. I wonder how he would feel if I asked him if he would like to keep ms and add cancer? Come on . Why release a treatment just to cause other diseases? Is it all about the money still?

    June 13, 2010 at 07:12 | Report abuse | Reply
  25. Kathy Brewster

    I have ths form of MS and had to give myself a shot every other day for 8 years until my skin could no longer support the shots. I now take a different intramuscular shot once a week which makes me sick and achey for two days, I plan my shots for Friday nights so that I do not lose any work time and as a result my weekends are far from pleasant. Price of 4 – 30 mcg pre-filled syringes is over $2500 a month. Interesting that no one ever talks about the cost of medication for MS. I am very excited that there may be something oral – perhaps to take the place of these shots? Maybe I will get my weekends back again!

    June 13, 2010 at 08:31 | Report abuse | Reply
  26. Greg

    The FDA is a joke. They are in bed with the pharma companies just like everyone else in the govt. Hurrying up to push something not tested for a long enough period of time. I have had MS for 9 years and HATE taking a shot, but better than taking something for ease that has no history. I went to MAYO not too long ago and they are not going to push this pill to their patients...hmm, some of the best doctors in the world aren't even going to recommend this.

    June 13, 2010 at 10:29 | Report abuse | Reply
  27. Sheree

    Hi everyone, I was diagnosed at age 18 I'm 41 now. My MS is Secondary Progressive & I'm one of the patients that all the meds backfire on : ( but I'm currently taken "Cyumedrol" & "Tysabri" monthly. I'll try anything so yes I will give this new drug a try!

    June 13, 2010 at 11:31 | Report abuse | Reply
  28. Sharon

    I'd recommend that everyone read the original research (the articles are open access in Pub Med) to understand the potential benefits and risks of this "oral" drug.

    The current drugs for MS (and I assume this one too) are aimed at reducing the number of relapses and brain/spinal cord lesions. Unfortunately, neither the number of relapses or lesions are significantly connected to the disease progression and disability that occurs in people with MS.

    I'd encourage CNN to consider an article on chronic cerebrospinal venous insufficiency (CCSVI) in people with MS. It's been rather ignored in the US media and many of us with MS are hopeful for the first time that this is a significant breakthrough.

    June 13, 2010 at 11:39 | Report abuse | Reply
  29. Janell Fontenot

    Mother of MS Sufferer............I have watched my daughter battle MS.for years
    She is a fighter...........has two children she is a great mom .We live in Louisiana so the summer is the worst..........She has tried all MS meds and react to all of them Doctors don't know why and keep trying
    About this new med I am not sure about it. sounds to risky !!
    try to help MS only to die of CANCER or some other infection...........get this med safer before you give it to anyone .............

    June 13, 2010 at 13:56 | Report abuse | Reply
  30. Dale Woolsey

    As a Canadian 65 year old man with PPMS for 25 years it is imperative for both Canada & Us to test and treat MS patients for CCSVI which Dr. Zamboni found to be the cause for MS. 90% of the patients he tested had blocked or restricted veins draining blood from the brain and causing excess iron build up in the brain. By using veinoplasty to open these veins all patients MS symptoms improved or disappeared. Hundreds of MS patients from Canada have gone to countries like Poland, India, Ireland, Kuwait, Bulgaria and can now go to Mexico & Scotland to be tested for CCSVI (chronic cvoronary spinal veinal insufficiency) and get the Liberation treatment.. In the mean time Canadian & US Ms Societies continue to test drugs to treat MS SYMPTOMS

    June 13, 2010 at 15:30 | Report abuse | Reply
  31. Dave

    Finally, a real medical breakthrough - something that will make the lives of patients less painful while treating their disease. Far too often medical science focuses way too much on cures and way too little on improving people's lives. This does both. It eliminates a constant need for needles and allows painless treatment. Congratulations to the many, many, many researchers and drug trial participants who made this possible.

    June 13, 2010 at 16:27 | Report abuse | Reply
  32. J Sommerville

    I was diagnosed with RRMS over 8yrs ago, and luckily have not had any bad relapses since (knock wood). I have tried the various injections, and I just can't get past the site reactions. This sounds like a great possibility, but I wonder how the doctors plan on monitoring people to keep the side effects to min (esp the potential for cancer!)? Especially with the almost disaster that Tysabri turned out to be.

    Of course, I wonder how expensive this drug will be? Without insurance, the injectable drugs are a few grand a month for every-other-day or once-a-week shots. If you have to take this every day, how pricey will that be and would insurance even remotely cover it?

    And Sharon I agree: I hope that more articles about CCSVI are written. I think this could be the true breakthrough all MS sufferers really need. Instead of taking drugs to control the symptoms of MS, we need a friggin cure!!!

    June 13, 2010 at 18:16 | Report abuse | Reply
  33. jim d.

    June 11th, 2010 16:20 ET

    Cannabis helps with MS. Why don't they let the FDA test that out? Oh thats right, becuase the DEA classifies cannabis as a more dangeous drug then cocaine and herion so they won't even let the FDA test it. WAY TO IGNORE COMMON SENSE!!!!

    this is not a true statement. marijuana and heroin are class I, cocaine is class II. look it up before you ramble on about that which you know nothing.....

    June 13, 2010 at 18:23 | Report abuse | Reply
  34. bob

    Glad I was never healthy with cerebral palsy so I never have to worry about a cure that will give me cancer, herpes and kill me. Find a cure for CP, you'll find one for MS too. But alias there is no money for a cure for any neuro impacts, only bad treatments and experiements.

    June 14, 2010 at 08:40 | Report abuse | Reply
  35. philygrl

    My daughter has MS and two years ago had a cold which progressed overnight into pneumonia. She spent a month in the ICU on a vent then spent time in physical rehab to build her strength to be able to walk and care for herself. The ICU doc felt that the reason she could not fight the infection was related to her MS med depleting her white blood cells rendering her incapable of fighting off a basic cold. Her neuro doc disagreed saying that it was impossible. Now I read this article and am amazed that anyone would think it is a good idea to take a med that will leave a person defenseless against a cold let alone the cancer issue. I certainly hope that the docs who eventually prescribe this new drug are very carefully monitoring their patients WBC count to ensure that the patient is not being rendered defenseless.

    June 14, 2010 at 09:36 | Report abuse | Reply
  36. Mike Ng

    Based on the side effects.

    You can intuitively estimate that the drug will lower blood pressure so will likely cause more heart attack in women & palpitation (tachycarida or other).
    Lower energy
    Higher incident of cataract and glaucoma -higher liver enzyme & blindness

    Develop coughing, and which will lead to asthma.

    This is not a treatment because the side effects far outweights the any temporary gain.

    If you looking for tremor treatments use gastrodia -very safe & effective. Just trying to help.

    June 14, 2010 at 11:23 | Report abuse | Reply
  37. Ted

    My wife has had M.S. for the past 17 years and is on Beta Seron and is able to work 40 plus hours a week. I think that she will stay on this injectible for as long as it is working for her. She has no problems with tgiving herself the shots with the Autoinject that they have out and with a very small and fine needle. However can someone explain to me why, when we moved and she started to see a new Neurologist the first thing he wanted to do was take her off all the meds that have been working for her and put her on something totally different? Is this because he was'nt getting a kickback from the companies that manufacured the meds she was taking. If so thats whats really wrong with this countries medical professions.

    June 14, 2010 at 11:56 | Report abuse | Reply
  38. MS Patient

    You give this coverage but not CCSVI? I know you have been receiving request upon request from many different MS patients to cover CCSVI–there is a very informative ireport on CNN about it, submitted by a patient because its impossible to get coverage.

    Shame on you!

    June 14, 2010 at 18:01 | Report abuse | Reply
  39. Jim Dyer

    I am a medical malpractice attorney in Tucson, Arizona, diagnosed with PPMS three years ago. I was told there was no effective treatment. I read hundreds of articles and studies. I ran across a META study by the Harvard School of Public Health. The study analyzed data from the “Nurses Health Studies” (80.000 nurses) for the last 20 years, and found that nurses who took any amount of vitamin D daily had a 40% lower incidence of MS.
    I found another study, a mouse study, from the University of Wisconsin-Madison. Colleen Hayes, PhD was able to completely stop the development of EAE (the mouse model for MS) by pre-treating the mice with calcitriol (hormonal vitamin D) before injecting the mice with human myelin to induce the EAE (Typically, the presence of the foreign myelin triggers an immune response that over-reacts and attacks the nerves of the mice as well. The vitamin D completely stopped the white blood cells from attacking the native nerve tissue of the mice).
    I contacted these researchers, discussed their findings, and with the help of some dosing recommendations from an article by Michael Hollis, raised my 24(OH)D (vitamin D blood level) to between 100-150. I kept my blood level in that range for 10 months, and had a gadolinium MRI, which showed no active MS lesions (I had active lesions when diagnosed a year earlier).
    The Harvard School of Public health the published another study based on blood samples obtained from the department of defense. The study found that those individuals with the highest 25(OH)D levels had a 62% lower incidence of MS than individuals with the lowest 25(OH)D levels.
    Another “study” was published by the University of Wisconsin. This study was composed of 12 individuals with RRMS, and no control group. The study was only 28 weeks long, and found that people with MS can take HUGE doses of vitamin D (resulting in 25(OH)D levels as high as 3 ½ times the upper limit of normal– over 350 nml/L) with no side effects. MRIs taken at the end of this short (28 week) study revealed that 4 participants had no active lesions, and the remaining 8 had a 50% reduction in the number of active lesions.
    I had another gadolinium MRI in June 2008 (18 months after the first “clean” MRI) and then a third MRI in July, 2009, and I still have no active MS lesions. I have maintained my 25(OH)D level>100 and 150 throughout, and have obtained serial 25(OH)D levels and blood calcium testing, and have had no increase in blood calcium or other side effects. Based on some advice I receive from Dr. Cannell of the “Vitamin D council, I have been maintaining my 25(OH)D level right around 150. Maintaining this level requires first getting your blood level up ( with a combination of supplements and/or UVB (only) lights – do not go to a “tanning salon” – you will get skin cancer), and then taking 15,000 IU per day. You can find 50,000 IU vitamin D3 online from a couple of sources by “Googleing” “50.000 IU vitamin D3 price”, or you can get 5000 IU pills from Warehouse Vitamins or online at http://www.vrp.com. Studies have shown rthat 15000 IU of D# can be taken for extended periods with no side effects.
    The research from the Harvard School of Public Health and the University of Wisconsin shows that vitamin D has an immunomodulating effect that stops white blood cells from attacking native tissue. Raising my 25(OH)D level stopped the progression (at least radiographically) of my MS for the past 4 years. I have not found any contraindication for taking vitamin in conjunction with any other treatment, but you should check with your Doctor. If you want to see a discussion of my research, with citations, so you can read the studies yourself, go to http://www.vitamindmscure.com.
    In February of last year, British Researchers found that the gene they believe to be primarily responsible for MS is regulated by vitamin D. And still there are no definitive studies.

    June 14, 2010 at 19:01 | Report abuse | Reply
  40. Tina Veach

    I want to say that this drug is just one more way for neurologist to get kick backs from the drug companies. The drug companies don't care if we have liver damage from lets say Rebif like I did. Maybe even worse have PML or die from Tysabri.

    I was liberated on Thursday and before I had treatment for CCSVI I couldn't blance, my eye hurt, my bladder was over acting, brain fog and I couldn't point my toes on my right foot and the list goes on. Not ONE SINGLE DRUG TOOK THESE SYMPTOMS AWAY. I had stenosis in the right jugular and the azygous vein was so stenosed that the doctor could barely get the catheter through my vein. I was out at dinner and a move 4 hours later with my husband with barely any pain. I took a Naproxen and was fine!!!

    It seems the drug companies want us sick. The NMSS's money they are funding isn't going to have any angioplasty done. People will still be sick. You can't see stenosis in the azygous vein with MRV. So there study is going to be a waste of money. My right jugular was so low that the doctor didn't think he would see it with a doopler either. I don't feel like I have MS anymore. The drugs are not as good as liberation. I am proof!!!

    June 14, 2010 at 20:10 | Report abuse | Reply
  41. sandman


    Ths drug kills white blood cells......CCSVI has shown amazing results

    June 15, 2010 at 12:17 | Report abuse | Reply
  42. fingolimod tester #2

    I also participated in the phase 3 study. I unfortunately developed MRSA in both arm pits because the fingolimod keeps all the bad stuff in the lymph nodes, so I was discontinued from the study, kicked out of it, actually. I was also told to watch out for developing lesions on other parts of my body, because that could mean that I have developed hidradenitis suppurativa, so I watch and pray I don't have any more outbreaks. I feel lucky that in the 3 years since discontinuing, I haven't!

    None of the MS drugs work for everyone; none of them work for me. So I am using LDN and watching what's happening with CCSVI. I have friend who is going to Poland for treatment later on this month. I pray that she has a successful outcome!

    June 15, 2010 at 12:43 | Report abuse | Reply
  43. Sheila McKee

    Does this new MS medication affect weight? I am interested tin hearing about the future results in this drug.

    June 21, 2010 at 14:40 | Report abuse | Reply
  44. Taking Fingolimod

    I have been part of the study for two years. Am doing better on it than I was on an injectable. It seems well worth it so far. As to side effects. Yes, there is an increased risk of infection. I do have ear infections quite a bit, but then again, I have always had ear infections, just not as often as I do now. I did have a pre-cancer skin abnormality, but if you watch for this closely, shouldn't be a problem–easily removed. Your immune system with this drug is not completely shut down. Plus, I very much suspect that I was on the higher dosage (I'll know in a few weeks), so I expect less of a problem with infections.

    Your decision, but were I was progressing before, I am not any more. In fact, it seems that I am slowly improving. Keep in close contact with your doctor and get checked regularly by a dermatologist for signs of skin cancer (one of the least scary forms of cancer). I don't know if this is the only sort of danger from cancer, nor about other possible side effects, so check it out.

    June 23, 2010 at 17:48 | Report abuse | Reply
  45. Get Liberated from CCSVI/MS

    Fingolimod – FTY720 – Gilena their all the same thing, and I could swear right now it advanced my syptoms within 12 weeks into the clinical trials, as a matter of fact I sincerely believe that it was Fingolimod who triggered my advance from rrms to spms.

    Next thing you will have millions who will immediately run like fools to the pills instead of the injections regardless.

    But the fact of the matter is that pill or no pill, injection or no injection they all will be needing assstance in walking and walkers and wheelchairs within 10-12 yrs, Im not being pessimistic, Im being realistic.

    Some mser's are dodging CCSVI Liberation procedures because their scared of it, even tho its minor day surgery (under and hour, under local anesthetic) and a painless procedure, but their stil scared of the lil wire and the balloon.

    Soooo they will all jump to the cool new pills and every single drug company will have one ready for each of them any minute now, actually most others are in Phase 3 or 4 right behind FTY720.

    But the results will be CATASTROPHIC because in reality what they really need to correct the stenosis in some of their veins, and their blood flow, and not take any more poison regardless of its new cool presentation.

    Thank Dr Paolo Zamboni of the University of Ferrara in Italy for the discovery of CCSVI in MS

    Its Vascular and it becomes Autoimmune afterwards, not the other way around –

    Dr Zamboni will eventually win the Nobel Peace Prize in Medicine for this huge breakthough, which will be even bigger than the Polio vaccine ever was, because this disease not only paralyses but it can also make you blind and all during your youth.

    June 24, 2010 at 20:47 | Report abuse | Reply
  46. Buck

    I have had rrms for 3-4 yrs. A year ago got pulsating tinitus in one ear. After reading about ccsvi just wondering if they could be connected. Seems logical to me. Btw, I'm on rebif.. It's working so I'll continue with the shots.

    June 26, 2010 at 19:00 | Report abuse | Reply
  47. william mirch

    Is this durg available

    July 19, 2010 at 20:37 | Report abuse | Reply
  48. rtyecript

    I really liked the article, and the very cool blog

    August 25, 2011 at 17:27 | Report abuse | Reply
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.