New Lesion - Journey from 11/2/18 to 3/1/19

On November 2, 2018, I awoke with the feeling that my forefinger and thumb had super glue on them - you know that feeling when you get super glue on your finger and you can still feel things but the sensation is duller or abnormal somehow?  That is what it felt like.  I immediately recognized this as an MS symptom.  Then I took a shower and in the heat, the feeling of dulled touch sensation began to spread to my entire hand and then I was even more sure this was something to do with MS.  I had taken part of the day off because my son was out of school.  For the majority of the day, the "numbness" remained mostly from the tip of my thumb to the tip of my pointer finger.  In the afternoon, we went to Chuck E Cheese and played some games which was fine, but there is a gorilla strength game where you're supposed to grasp these handles and then they vibrate and I guess the point is to hold on as long as you can.  My son wanted me to try the game after he had taken a turn; I found it quite easy since the sensation to my hand was quite dull.  I found it to be quite strange and I'm still not really sure what the point of the game was, but oh well.
Throughout the weekend, the numbness continued, varying between two fingers to whole hand to up the arm.  Monday I was scheduled for my regular neurology appointment where we discussed this new symptom and how this was likely a new lesion on my cervical spinal cord.  I knew going into the appointment that this was likely caused by a new lesion - I had dealt with this same issue before but in my left hand so when it happened to my right hand I knew this wasn't just an exacerbation of an old lesion.  I was glad to learn, however, that my strength in my right hand was still good and it was just the lack of sensation that ailed me.  We decided at my last appointment that it was time for me to get an updated brain MRI so after this newly-discovered symptom the decision was made to also get a new cervical spine MRI (I haven't had a cervical spine MRI since right after my diagnosis).  I was very curious to find out what the cervical spine MRI shows because I don't think I had even had the issues with my left hand before my original MRI of the spine.
Monday and Tuesday were frustrating with work creating some aggravations due to having issues typing due to my lessened sensation in my fingertips - kind of like trying to type when your hands are REALLY cold (but it is only one hand having the problems).  Also, the sensation (or lack thereof) began spreading into the right side of my torso, ugh!  Monday evening, I had a private volleyball lesson and was a little worried that I would have issues there but I did not - thank goodness for muscle memory!  The lesson actually gave me a chance to take my mind off of my hand for a bit which was very nice!

Today (November 7th), I am struggling!  My hand feels kind of limp and it is kind of painful to try to type, utilize the computer mouse, manipulate binder clips, and otherwise use my hand.  The pain and "limpness" goes into my arm from time to time making some of these day to day activities even more difficult and frustrating!
What has been most frustrating over these last few days is how hard it is to deal with this while taking care of children - when I was first diagnosed, we had no kids so I really only had to take care of myself (and a little bit, my husband), but now I have to take care of myself and two little ones (my husband helps tremendously, but I don't like to be weak and admitting that I can't do something or need help or need a break is really hard for me).  I know it has been many years since I last posted on this blog, but I felt that I needed to memorialize my symptoms as well as my frustrations and other feelings.
What seems most crazy to me is that the issues I had with my left hand began in November 2010 - eight years ago to the month!  I wrote the following in a blog post from January 27, 2011:

Since My Diagnosis

As I sat at work today, I had the sudden realization that I had regained almost full feeling in my left hand!  In late November, I began to notice some numbness in my left forefinger and thumb.  That numbness quickly spread into the rest of my left hand.  Now, for clarification, I don't mean to say that I had absolutely no feeling whatsoever in my hand, just that I had reduced feeling.  The numbness I experience almost feels as though the skin has gone numb.  I can feel pressure, but the sensation is reduced and feels abnormal.  It was really bad at one point - I had problems picking up the phone and typing with my left hand, but I got used to it and just made it work.  The numbness started to dissipate toward the beginning of this year and by the beginning of this week, I was only noticing numbness in my fingertips.  Today, it feels almost normal, I only notice slight numbness in my fingertips when I rub my fingers against an object.  Very exciting stuff!  It is weird how I just get used to the numbness and then all of the sudden it hits me that the feeling is gone.

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Also, back in December, I experienced numbness in my torso, mainly the left side.  At one point or another, the numbness had affected every area on my left torso and some parts of the right torso.  By the end of December, that feeling had mostly gone away, but there were times that although it didn't necessarily feel numb, it definitely felt weird and not normal.


Facinating, right?!?!?!


UPDATE (11/30/18):  Had MRIs  (brain & cervical spine) done on 11/20/18. My symptoms have gone from just 2 fingers (pointer and thumb) to whole right hand to entire arm to entire right side of body including up the back of my neck and into my ear and down into my right foot. From 11/19/18 through 11/22/18, my symptoms have just been isolated to my right hand.  My hand has also felt swollen at times and it can be hard or painful to bend my fingers. I reviewed my MRI scans and could see active lesion at top of spinal cord. Waiting to hear radiologist's opinion still.


UPDATE (12/3/18): New lesion at the top of spinal cord that I saw is all that was seen by neurologist which is good.  I have now began experiencing L'Hermittes occasionally (which indicated inflammation of an old lesion) along with continuing right hand numbness as previously described.  The issues with my hand have still remained isolated to my hand as of late without spreading into my arm and body.

UPDATE (1/8/19): For about a week now, I have noticed my hand feel normal from time to time and the "numbness" has been minor mostly flaring up with heat.  I can still feel slight dullness to the touch sensation, but am feeling much closer to normal!  Hoping to have that same realization I had back in January 2011 of a return to full feeling soon!!!  I still experience L'Hermittes occasionally also but that seems to be less severe as well and seems to happen less frequently.  For about 2-3 weeks, the L'Hermittes has been much more noticeable than the numbness in my right hand.
Towards the end of December, I got a letter from my health insurance company informing me that my Copaxone would no longer be covered and that I would have to switch to the generic glatirmer acetate.  This is something I have been dreading for some time (ever since they announced the generic).  Generally, I am all for generics - I am find with generic ibuprofen, acetaminophen, antibiotics, etc..  However, when I know that a generic medication can vary up to 20% from the original (and I have no way of knowing how much the glatirmer acetate generic varies) and we are talking about a disease that cannot be reversed, I am just not okay with becoming a guinea pig.  I have had ONE new lesion in EIGHT YEARS, which is pretty incredible.  I was lucky/blessed that we chose Copaxone at the onset (before step therapy reared its ugly head) and that Copaxone has worked so well for me.  If I switch to the generic and due to variations (of up to 20%), it wasn't as effective for me and I started getting new lesions or even bad exacerbations, then I may have to try other therapies and fail (possibly leading to various disability) before they'd allow me back on Copaxone.  Step therapy may be the DUMBEST thing I've EVER heard of!  So when I received that letter, I cried then started thinking about what I needed to do to try to stay on Copaxone.  I made some calls and was eventually told that I was approved to remain on Copaxone until 2023 (YAY! I hope...).  The days after receiving the letter and hearing that I may actually get to remain on Copaxone were stressful and emotional which is not generally a good combination for a person with an auto-immune disease and I definitely noticed my symptoms were stronger during those times.  On 1/4/19, I called the specialty pharmacy to refill my Copaxone prescription with the expectation that I'd be told that I could only get the generic and having to jump through a bunch of insurance red tape, but I was pleasantly surprised to have no issue whatsoever and today (1/8/19), I received my medication and it is Copaxone!  YAY!!!  Praying that I truly have no issues with refilling the prescription in the near future.

UPDATE (3/1/19): The "numbness" in my hand/right side has gone away completely!!! The L'Hermitte's is a little more stubborn but is only occasional now! Still no problems getting Copaxone!  All is looking up!  Remaining optimistic.

$2 CHALLENGE

Inspired by Amy from the Bobby Bones Show, I am instituting the TWO DOLLAR CHALLENGE to raise money for the National MS Society.  Amy challenged listeners to give $3 to help pay wages for nannies working in a Haitian orphanage.  Her goal was to raise $120, but ended up raising something like $12,000.  INCREDIBLE!

Now, I am challenging anyone and everyone to give just $2 to help fund programs and services for people living with MS and to help fund research to discover the cause of MS, treatments for MS, and, hopefully, one day, a CURE.

I am participating in Walk MS for the 6th year.  I will be walking on April 26th and I am trying to raise money for this worthy cause.  Please help by making a $2 donation today!  Every dollar makes a difference. $2 is less than a value meal at McDonald's or a coffee at Starbucks.  Please consider making this SMALL monetary donation to a GREAT cause!

Visit my page to make your $2 donation.

THANK YOU!!!!

Research: "No Association Between CCSVI and MS"

Recent study shows that there is no asscociation between MS and chronic cerebrospinal venous insufficiency (CCSVI).  Read about it here.

New Oral Therapy, Plus A Life Coach

Ok, it has, again, been FAR too long since I posted.  Taking care of an infant is very demanding and, therefore, my blog has been on the back burner for awhile.  I have been meaning to post for some time now, but haven't (obviously), but with the news that the 2nd oral therapy had been approved by the FDA, I knew I would have to post today!

Before I get to that, however, I want to tell you all a little about my friend, Rhonda.  She is a Life, Wellness and Career Coach!  If you feel stuck, whether it be because of a job-related issue, a health-related issue, or just a life issue and you need someone to help you through, I would encourage you to contact Rhonda.  Although she is equipped to help with a range of issues, I should mention (since this blog is about MS) that I met Rhonda through her work for the MS Society, so I know she fully understands MS and how it affects people's lives (not just their health).  If you think you might benefit from her services, check out her website.  Disclaimer: I am, in no way, benefiting by telling you about her services (She is not paying me or anything for this "plug").  She is just a friend who I believe can make a difference in people's lives and if you or someone you know could use help getting out of a "rut", then she may be able to help.

Ok, now onto the exciting news!  If you didn't already know, the FDA approved teriflunomid, an oral therapy for relapsing forms of MS!  The following excerpt was taken from the NMSS website (here):

The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio,® Genzyme, a Sanofi company) to treat relapsing forms of MS. This is the second oral disease-modifying therapy approved for the treatment of multiple sclerosis. The therapy is expected to be available for prescription by October 1, 2012 in the U.S. The company has also applied for regulatory approval in other parts of the world.
“We are greatly encouraged to see a new oral therapeutic option become available to people living with MS,” advised Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and incoming Chair of the National MS Society’s National Medical Advisory Committee. “As with any new therapy, the long-term safety of Aubagio will need to be carefully monitored,” he added. Dr. Timothy Coetzee, Chief Research Officer at the National MS Society agreed. “With the collaborative research underway around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS.”

About Teriflunomide/Aubagio: Multiple sclerosis involves immune system attacks on the brain and spinal cord. Aubagio (pronounced oh-BAH-gee-oh) is a novel oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes), reducing the proliferation of T and B immune cells active in MS and also inhibiting the production of immune messenger chemicals by T cells. It is not thought to affect resting immune cells that are not in an activated state. Two doses (7mg and 14 mg) have been approved.
Potential benefits: Three large clinical trials of Aubagio have been completed, and at least two more are ongoing. In the phase III TEMSO study, Aubagio reduced the average number of MS relapses and disease activity on MRI scans significantly more than inactive placebo in 796 people with relapsing forms of MS.
In a recently completed phase III TOWER study involving 1,169 people with relapsing-remitting MS, oral Aubagio reduced relapses compared with placebo over at least 48 weeks, according to a company press release. Of two different doses tested during the TOWER trial (7 mg and 14 mg), the higher dose also slowed progression of disability.
In another study, called TENERE, Aubagio was compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and did not reach its primary endpoint (the main question posed by the study) -- the “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events defined as treatment failure among the Aubagio and Rebif groups.
Potential risks and screenings: In trials to date, Aubagio was generally safe and well tolerated. The most common side effects experienced by participants in clinical trials include diarrhea, abnormal liver tests, nausea, flu, and hair thinning.

The NMSS website also has some FAQs regarding teriflunomid and links to the various studies, the FDA press release, etc.  Be sure to click on the link above to read this valuable information!
This is such exciting news!  As someone who takes a once-daily injection, an oral therapy is extremely enticing!  I have stayed away from Gilenya (the 1st oral therapy) because of the risks for pregnant women/ women who want to become pregnant.  As you all now know, I recently had my first child.  We have not decided whether more children are in our future yet, so I am hesitant to switch to an oral therapy until we are sure that we don't want more children.  But, if I knew that we were done having kids, I would DEFINITELY be talking to my neurologist about possibly switching to one of these exciting oral therapies!  I can't wait to hear more about how people do on the teriflunomid!

Sounds like the little man is waking up - back to MOMMY duty!

While the Baby is Sleeping . . .

Well, I know it has been awhile since I posted, but I have a good reason, I swear!  On June 27th, my son decided to make an early appearance into the world! He came a month early (he was due on July 27th)!  Needless to say, my husband and I were not as prepared as we would have liked to have been.  And even though he still isn't even supposed to be here yet, now that he is here, we could not imagine life without him!  So, I have been just a LITTLE busy the last four weeks and haven't had much time to get on my blog to post.  But, I felt it was time to post at least a little something and in the wake of the news on interferons that broke last week, today seemed to be the perfect day (plus the baby is sleeping right now and I felt as though I had just enough energy to put a little something together).  So, in case you haven't heard, the news on interferons is as follows (from the NMSS website):

In a study looking at more than 2,000 people enrolled in MS clinics in British Columbia, there was no reduction in MS progression in people treated with interferon beta compared to untreated controls. This study did not address the value of interferon beta in reducing MS relapses and the development of lesions (tissue damage) or improving quality of life in people with MS. While the results are at variance with other recent research and need to be confirmed, this carefully conducted study presents some evidence that there is an unmet need for treatments that reduce the likelihood of MS progression. Research also is needed to find more comprehensive and better tools to measure the effectiveness of MS treatments. Afsaneh Shirani, MD, Helen Tremlett, PhD, and colleagues (University of British Columbia, Vancouver, Canada) report the findings in the Journal of the American Medical Association. This study was supported by the Canadian Institutes of Health Research, the National MS Society, the MS Society of Canada and others.
Background: Multiple sclerosis involves immune system attacks against the brain and spinal cord. Several treatments, called disease-modifying therapies (DMDs), are available that can reduce the inflammation associated with the immune attack and reduce disease activity, such as relapses and the development of new lesions. The effect of these therapies on damage to nerve fibers is not well understood, and it is controversial to what extent they reduce the progression of MS, which is associated with nerve fiber damage. Data on MS progression comes largely from what is reported from relatively short-term clinical trials. Some of the difficulties involved in answering this question using traditional, randomized clinical trials include the fact that it would take a long time to observe effects on progression, and that the conditions of a trial do not necessarily reflect the ‘real world’ of treatment and how it might affect disease progression.
The study: The investigators collected information from the British Columbia MS database, which captures about 80% of all people with MS in British Columbia and links the four MS clinics in that province. They observed people with relapsing MS who had registered with a clinic between April 1985 and December 2004 and who were eligible for interferon beta treatment. Within this group, they compared 868 people who were treated with interferon beta, 829 people who were not treated, and 959 historical controls (people who were untreated before approval of interferons for MS). The main outcome measure was time to a confirmed and sustained EDSS (a scale used to measure MS-related disability) score of 6. This score indicates “intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.”
The results indicated that those treated with interferon were just as likely to progress to an EDSS of 6 as those who were not treated. The lack of difference among patients persisted whether the controls were contemporary or historical, or whether an EDSS of 4 rather than 6 was considered. However, the authors point out that this study is not capable of discerning a subgroup of patients who might indeed experience reduced progression through interferon use.
Comment: In an accompanying editorial, Tobias Derfuss, MD, and Ludwig Kappos, MD (University Hospital, Basel, Switzerland) point out that the comparison groups used in this study might have tended to underestimate a possible long-term benefit of treatment. They also comment that although this study was methodologically sound, it is subject to the inherent challenges of an “observational” study. In this type of study, researchers infer their conclusions based on observing treated versus untreated patients, as opposed to a randomized, placebo-controlled trial, where the researchers assign patients to either active treatment or a placebo. The results are not likely to stop the debate over the long-term effectiveness of DMDs, including interferons, on MS progression. Recently, Italian researchers using novel study design found that MS treatments were associated with a reduction in MS progression.
The Canadian study’s findings on longer-term benefits of interferons do not negate their proven value for reducing MS relapses, which have been linked to long-term progression, and the development of lesions (tissue damage). Important research is underway to help determine which people may respond best to interferons; success would help guide treatment decisions by people with MS and their health care providers, and pave the way for personalized medicine in multiple sclerosis. Research also is underway to address the need to find more comprehensive and better tools to measure the effectiveness of MS treatments. Novel imaging technology and refined clinical measures may help to capture the full spectrum of MS-related damage, and may improve our understanding of how both currently approved and experimental therapies affect MS progression.

Pretty crazy to think that the Interferon treatments may not be slowing progression!  I would love to hear people's thoughts on this.  I was taking Copaxone before getting pregnant and have been off my meds since last November.  I will go back on the Copaxone as of August 1st.  Since I have not taken one of the interferon treatments, I don't know how to respond to this news, but I can't quite wrap my head around it!  The interferons have been around the longest and I seriously thought about taking Avonex or Rebif until we finally decided on Copaxone.  I think I would be really disappointed right now if I had chosen one of the interferons!  If you take/took an interferon, let me know what you are thinking/feeling about this news.

Back to baby duty.  I will try to post again soon!

Pregnancy & MS

I recently got a comment requesting information on how MS is affecting my pregnancy.  Rather than just reply to that one person, I thought I would share with all who may be curious.

I have been very lucky.  I have had a fairly "easy" pregnancy and my MS has been very manageable and almost non-existent.  By "easy" pregnancy, I mean that I got lucky and didn't really have any morning sickness and aside from not sleeping well and minor aches and pains, I haven't had any real complaints.  Regarding my MS, I stopped taking my MS medications when I learned I was pregnant, so I have been off treatments for approximately 30 weeks now.  I have barely even thought about my MS throughout this pregnancy because my focus has been on having a healthy baby.  The only time I am really reminded of my MS is when we take our dog for walks (since I no longer take daily shots, I am not reminded quite as frequently).  On our walks, I do fine until we stop walking.  At that point, I generally have some sort of numbness or tingling in my lower back, buttocks and/or legs.  It is nothing debilitating, more annoying than anything else.  It is my understanding that these are just "residual" symptoms, meaning these are not new symptoms or relapses, just my old symptoms recurring.  Some of my first and most prominent symptoms have consistently been numbness and tingling in those areas and, to my knowledge, I have not experienced any new symptoms since I got pregnant.  I have spoken with my neurologist about getting an updated MRI done after the baby is born so that we can see if any new lesions have formed, but I am not sure how telling that will be regarding the pregnancy considering my last brain MRI was 4 months prior to my diagnosis (April 2010). 

That is an overview of how everything has been.  In my research, I have read that it is common for MS to go into remission during pregnancy because the immune system is suppressed during pregnancy and, therefore, not attacking itself.  I think this has been my experience just based on how I have felt physically throughout my pregnancy. 

As I am sure all of you know, MS varies so much from person to person and I was lucky enough to have been diagnosed very early on (when I only had 2 or 3 lesions).  Also, I had been doing very well before getting pregnant.  I had been on treatments for over a year and had been essentially symptom-free since January 2011 (about 10 months before getting pregnant). 

I hope this helps anyone who has/had questions.     

WORLD MS DAY 2012

Today is World MS Day - a day to advocate and spread the word about MS.  My goal since my diagnosis has been to educate people about MS in any way that I can in hopes that, once people understand what MS is and how devastating it can be, more people will want to get involved in helping find an end to MS.  World MS Day is designed to spur people to do just that.  Today, I received my newest MSF emailer and in it was some VERY exciting news - more progress in MS research.  Below is a few excerpts from the emailer.

Neutralizing Enzyme May Hold Key to Staving Off MS

Researchers studying MS have long been looking for the specific molecules in the body that cause lesions in myelin, the fatty, insulating cells that sheathe the nerves. Nearly a decade ago, a group at Mayo Clinic found a new enzyme, called Kallikrein 6, that is present in abundance in MS lesions and blood samples and is associated with inflammation and demyelination in other neurodegenerative diseases. In a study published in Brain Pathology, the same group found that an antibody that neutralizes Kallikrein 6 is capable of staving off MS in mice. 

"We were able to slow the course of disease through early chronic stages, both in the brain and spinal cord," says lead author Isobel Scarisbrick, Ph.D., of the Mayo Clinic Department of Physical Medicine and Rehabilitation.
Researchers looked at mice representing a viral model of MS. The model is based on the theory that a viral infection early in life results in an eventual abnormal immune response in the brain and spinal cord. One week after being infected with a virus, the mice showed elevated levels of Kallikrein 6 enzyme in the brain and spinal cord. However, when researchers treated mice to produce an antibody capable of blocking and neutralizing the enzyme, they saw a decrease in diseases effecting the brain and spinal cord, including demyelination. The Kallikrein 6 neutralizing antibody had reduced inflammatory white blood cells and slowed the depletion of myelin basic protein, a key component of the myelin sheath.
"These findings suggest Kallikrein 6 plays a role in the inflammatory and demyelinating processes that accompany many types of neurological conditions," says Dr. Scarisbrick. "In the early chronic stages of some neurological diseases, Kallikrein 6 may represent a good molecule to target with drugs capable of neutralizing its effects."

It is so exciting that researchers continue to find new ways to attack MS so that it stops attacking us!  It would be great if they could get a medication formed and start testing this theory out - sounds very promising.

Adult Stem Cells from Bone Marrow Repair Myelin in Mice

A recent study reports that human mesenchymal stem cells (MSCs) have been used in animal models of MS to not only successfully block the autoimmune MS response, but also to repair myelin. Researchers say this demonstrates an innovative potential myelin repair treatment for MS. The human MSCs used in this study were culled from adult stem cells derived from the bone marrow.

The Myelin Repair Foundation (MRF) announced the results of a new peer-reviewed research study published in Nature Neuroscience. Funded by the MRF, this research was conducted by Case Western Reserve University scientists.

Compared to the controls, this research study showed fewer and smaller lesions found on the nerves in the MSC treatment group.

Research by others and results of their own work indicated hepatocyte growth factor, which is secreted by mesenchymal stem cells, was a likely instigator.
The scientists injected animals with 50 or 100 nanograms of the growth factor every other day for five days. The level of signaling molecules that promote inflammation decreased while the level of signaling molecules that counter inflammation increased. Neural cells grew and nerves laid bare by MS were rewrapped with myelin. The 100-nanogram injections appeared to provide slightly better recovery. 

To test the system further, researchers tied up cell-surface receptors, in this case cMet receptors that are known to work with the growth factor. 
When they jammed the receptors with a function-blocking cMet antibody, neither the mesenchymal stem cell medium nor the hepatocyte growth factor injections had any effect on the disease. In another test, injections of an anti-hepatocyte growth factor also blocked recovery. 
The researchers will continue their studies, to determine if they can screen mesenchymal stem cells for those that produce the higher amounts of hepatocyte growth factor needed for effective treatment. That could lead to a more precise cell therapy. 
"Could we now take away the mesenchymal stem cells and treat only with hepatocyte growth factor?" Miller asked. "We've shown we can do that in an animal but it's not clear if we can do that in a patient." 
They also plan to test whether other factors may be used to stimulate the cMet receptors and induce recovery.

 This is more great news in MS research!  I love the continuing research regarding stem cells and how they can be used to help with so many problems, including MS!  This is great to learn that something may actually be able to REPAIR myelin - something I thought was probably beyond the realm of possibility!

Stem cell research and CCSVI all in one blog!  Oh my!

FDA Alerts on Potential Dangers of “Liberation Therapy” for CCSVI

The U.S. Food and Drug Administration (FDA) is alerting people with MS to the risks of serious injuries and death associated with certain procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). The benefits of these experimental procedures, commonly known as “liberation therapy” or the “liberation procedure” have not been proven, says the FDA, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved. 

The FDA’s announcement is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.

The “liberation procedure” uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of cases involving death, stroke, detachment, and migration of the stents, as well as damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.

Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause MS or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established, according to the FDA.

The FDA gave the following reasons for issuing the warning:

There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.

Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.

The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.

There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS, or improves the quality of life for MS patients.

It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.

“Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”

Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program. For more information visit www.fda.gov/Safety/MedWatch/HowToReport.    

In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.

The FDA says it will continue to monitor reports of adverse events associated with “liberation therapy” or the “liberation procedure” and keep the public informed as new safety information becomes available.

Not surprising that the FDA is warning us about CCSVI; I think it was pretty clear that CCSVI treatment has not been proven to help MS patients - it seems to be very helpful for some but not helpful for others.  It is always important to research different "treatments" and "procedures" before diving right in.  It is nice that the FDA is recognizing this and looking into it though.

Finally, the emailer reports that Tovaxin has undergone a name change and will now be referred to as Tcelna (pronounced Te-SELL-nuh).  Tcelna is being researched as a treatment for secondary progressive MS.

Happy World MS Day! 

Last Year of my 20s

I turned 29 last week and officially entered the last year of my 20s.  I hope that this year is a great end to an era :)  I will have my first child, entering motherhood is sure to be amazing in more ways than one!  I will mark my 2nd anniversary of my diagnoses with MS in September and I will hopefully have an opportunity to get a new MRI and see if I have developed new lesions - I will keep my fingers crossed that I have not!  I am optimistic that this will be a good year!

In news, I just read a blurb that a study was done to see if there is a link between cell phone use and MS - lucky for all of us living in the technology-rich world, "no significant evidence for a pronounced association between mobile phone use and risk of MS or mortality rate among people with MS" was found.

Want to be involved in a clinical trial?  Check out one of these:

What Triggers MS in Kids? –

Investigators nationwide are recruiting 640 children with early relapsing-remitting MS or CIS (clinically isolated syndrome, a single episode of MS-like symptoms) and 1280 children without MS or CIS for a four-year study to determine environmental and genetic risk factors that make children susceptible to developing MS. The study, funded by the National Institutes of Health, leverages the National MS Society’s support of the Promise: 2010 Pediatric Network of Centers of Excellence.

Those under age 18 who had disease onset (MS or CIS) in the last two years may enroll in this study with the consent of their parents. Children without MS or CIS can enroll if they are 19 or younger and don’t have a demyelinating disease or an autoimmune disorder (except asthma). 

Participants are providing blood samples to test for genetic and environmental risk factors that may be associated with pediatric MS. Next, all participants are completing questionnaires about relevant environmental factors. Investigators also will draw information from participants’ medical records.

For further information, please contact Janace Hart (University of California, San Francisco) at (415) 514-2476.

Participate in a Trial of Vitamin D Supplementation –

Investigators at several centers nationwide are recruiting 172 people with relapsing-remitting MS to compare the effectiveness of the current recommended amount of vitamin D supplementation versus high dose vitamin D supplementation at reducing MS disease activity, when added to standard therapy with glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries).

To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please see: http://click.icptrack.com/icp/relay.php?r=28288047&msgid=425901&act=X8WI&c=263560&destination=http://www.clinicaltrials.gov/ct2/show/NCT01490502, or e-mail vitamindtrialms@jhmi.edu. 

Pregnancy & MS

Well, life has been pretty overwhelming lately.  I am now into my 6th month of my pregnancy and although I am very excited to welcome my baby boy into the world, I am definitely not ready/prepared.  Good thing we have 3 more months!  My husband and I are trying to get our basement finished before our little one arrives because right now we don't have an empty room for the nursery.  Due to my "condition," I have not been much help in the basement project.  I feel a little helpless, but I am trying to help in any way that I can.  Unfortunately, this pregnancy (or this pregnancy plus my MS) have me pretty tired!  I seem to make it through the work day ok, but when I get home, all I want to do is sit and/or sleep.  I know that my body is working really hard and it is normal to be tired, but we have SO much to do and SO much going on right now that being tired is not really an option right now during daylight hours.  I have been going to sleep around 9pm each night which helps, but the problem is I feel ready for bed around 7pm (some days even earlier).  Anyway, I just wish I had a little more energy to get everything done that needs to be done.

Speaking of pregnancy, this article was in my last emailer from MSF:

Pregnancy May Cut Risk of Developing MS

New research suggests that pregnancy may decrease women's risk of developing multiple sclerosis.

In an Australian study of 282 people with MS symptoms, having one pregnancy was associated with nearly halving the risk of developing MS symptoms compared to those who were never pregnant. Risk decreased even more with additional pregnancies, according to the study.

Study author Anne-Louise Ponsonby, head of the environmental and genetic epidemiology and research group at Murdoch Children's Research Institute in Melbourne, Australia, and her research team reported they found an association between pregnancy and a lower risk of MS symptoms, not a direct cause-and-effect link.

Previous research has found that pregnancy in women who already have MS is linked with lower rates of relapse. The researchers say this association may help explain why the incidence of MS in women has inched up over the past few decades, as more women delay pregnancy or have fewer babies or none at all.

“In our study, the risk went down with each pregnancy and the benefit was permanent,” said Ponsonby.

Researchers reviewed information about 282 Australian men and women between the ages of 18 and 59 who had a first diagnosis of central nervous system demyelination, which means they had their first symptoms similar to MS but had not yet been diagnosed with the disease. They were compared to 542 men and women with no MS symptoms. For women, the number of pregnancies lasting at least 20 weeks and the number of live births were recorded. For men, the number of children born was recorded.

The study found that women who were pregnant two or more times had a quarter of the risk of developing MS symptoms and women who had five or more pregnancies had one-twentieth the risk of developing symptoms than women who were never pregnant. There was no association between the amount of children and risk of MS symptoms in men.

“The rate of MS cases has been increasing in women over the last few decades, and our research suggests that this may be due to mothers having children later in life and having fewer children than they have in past years,” said Ponsonby.

The researchers couldn't say exactly why pregnancy may lower MS risk, but they speculated it could be the increase in estrogen during pregnancy or the effect pregnancy has on inflammatory genes involved in MS.

The information may lead to future studies looking into hormonal treatment or other treatments that may alter the disease course.

The study was published online in the journal Neurology.

This article really made me wish that I had gotten pregnant earlier on in my life.  I am 28 now, will be 29 when this baby is born (god willing he doesn't come THAT early), and it would appear that had I gotten pregnant in my early 20s or even earlier, maybe I would have significantly decreased my risk of developing MS.  I guess there is no point in dwelling on what might have happened had I gotten pregnant earlier, but it does make me wonder if I ever would have been diagnosed had I had a baby earlier.  I wouldn't have been ready to be a mom in my early 20s, so really it is best that I didn't have a baby then, but sure would be nice to not have MS.  Makes me think of a Shel Siverstien poem called Woulda-Coulda-Shoulda:

All the Woulda-Coulda-Shouldas
Layin' in the sun,
Talkin' bout the things
They woulda-coulda-shoulda done...
But those Woulda-Coulda-Shouldas
All ran away and hid
From one little did.

 We all have woulda-coulda-shouldas, but we have to learn to live with the way things are (the "dids").  Don't get me wrong - I am very happy with the way my life has turned out.  I love my husband, my family, my job, my unborn baby boy, etc.  But who doesn't wonder and who doesn't wish certain aspects of their life was different?

100th Post!

This is my 100th post!  What a milestone!

Last Saturday was my local Walk MS - we had a great turnout and I was, again, reminded of just how blessed I am.  My husband, my parents, my boss, 2 co-workers/friends, and a high school friend all walked with me!  In addition, my high school friend, who is now a high school teacher and coach brought her varsity softball team out to walk AND they made t-shirts for our team!  It was so great to have so many friends/family supporting me by walking beside me!  I am constantly amazed at the incredible people in my life!  I have such a great family, great co-workers, and great friends who are always so supportive; I am truly blessed!  Also, my sister made a HUGE donation this year helping me reach my lofty $3000 fundraising goal!  Even though she lives too far away to walk with me, she is always super supportive of my efforts!  I also had a number of other great friends donate, helping me reach my goal - I am always overwhelmed at all of the support I get.  Sometimes I probably don't seem a appreciative as I am.  I am always trying to get people involved and raise as much as I can, and sometimes I don't always realize how burdensome that can be.  But, when I really reflect, I could not ask for more supportive friends and family.  Thank you to all who walked and thank you to all who donated!  I was able to surpass my personal fundraising goal and I think we will surpass our team fundraising goal (the totals are not final yet, but I am very confident)!  It means so much to me to raise money for research.  As all of my friends, family, and readers know, the ultimate goal is to end MS - to find a cure!  And we can do that, I really believe that!  I just hope that the cure comes within my lifetime!

Thanks to all who have supported me in all of the ways that you have!