Thursday, September 27, 2012

Carnival of MS Bloggers #124

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

MS Hug, Montel Williams, and Massage

by Estizer of MS Open Mic

 I read a blurb in the NMSS Magazine that stated African Americans with MS are less likely to use any of the disease modifying drugs than people of other races. That got my attention although I do think its a matter of personal choice,I choose to do drugs! I set out to find the nearest African American support group to check this out. That was 1.5 hours away in Philadelphia.  Like any other group I’ve come upon, I talked more than anyone in the room. Except this one guy, he was pretty cool. I brought up the article and as it stated most of the people in the room were not on medication. But what the article failed to address was how many people in the room had insurance or co-pay issues.  As I looked around the table I was far more concerned with the level of obesity and a host of other health issues that must only complicate MS.

Everyone went around the table and talked about what bothered them last month and then it was the cool guys turn)At first he had a burning pain in his leg JUST LIKE MONTEL but when Montel said it I thought it was totally BOGUS DUDE and he just wanted to smoke some weed, but now I believed him! (Sorry Montel) Next the cool guy said he had an MS Hug and EVERYBODY in the room was like “oh yeah, oh yeah…they’re the worse right? Hahaha, oh yeah” EVERYBODY except ME! All of the sudden I felt like I forgot to put my drawers on. I just sat really quiet so nobody noticed.

Now… how cool was I when two years later I felt an intense tightening around my chest, along with a pain and burning sensation. I clutched my chest… awashed in fear! This was it! Did I go to the emergency room? Because these were all the signs of a heart attack. I DID NOT. Why you ask? Because this was an MS HUG like the cool guy at the support group had described…just like it…right…everybody said so, right?

by Eddie at Multiple Stupidness

Montel Tells

When I first became ill, I scoured the internet for information on MS. Of course, this included YouTube, and there are probably hundreds of videos there concerning MS. Some are informational, some are testimonials and some are interviews or excerpts from programmes. Some are depressing and misleading, some are interesting and informative, and some are absolutely inspirational.

One of my favourites is the interview on Larry King Live of Montel Williams. I hadn't heard of him before I saw the interview, but he is an American talk show host who himself has been diagnosed with MS. As I watched it, it was wonderful not only because here was a man describing very, very similar symptoms to my own, but he was able to express things about MS that I felt, but had never been able to adequately verbalise.

An example of this is the injection I take every other day. I hate taking my injection. I hate it! Why? It doesn't hurt particularly. It's take less than five minutes, and I don't really suffer side effects from the betaferon like I did in the beginning. So why do I hate taking it? Montel Williams explains it beautifully, and very quickly I started directing people to these videos if they really wanted a clear, articulate expression of what MS is like and, because my illness felt so similar to his, a little of what my experience is like.

[Please go to Eddie's blog to view the videos.]

by Caroline of the Girl with MS

Many folks have asked about the benefits of massage for folks with MS.

Bottom line, I prefer spending my money and health on massage than on many of the Western "medicines" created for MS. Which don't seem to be true medicine. They are drugs that cover up the symptoms. So how do we reduce the symptoms and treat MS proactively?


Among other ways to live healthy including nutrition, exercise, and spiritual well being, massage is a great physical way to remove toxins from our bodies. Whatever caused our MS or whatever exacerbates it, the one thing we can do is keep our body as clean as possible.

Now this is not always easy. Trust me! Coffee, tobacco, alcohol, artificial sweeteners, fake foods, artificial or fake anything can send MS into a tizzy.

The goal always is to reduce these toxins and increase MS beneficial foods, such as cooling mung beans and detoxing apples.

One thing we can do to remove toxins is to have a massage. And what a treat it is!

Massage seems to help in several areas: spasticity, pain, fatigue, poor circulation, and mental wellness...ahhhh....

The National MS Society has good information about massage and bodywork therapies click here. Here is the NMSS summary of how massage effects (or not) the course of MS.
"Massage and the underlying disease of MS:

While massage can be helpful in relieving stress and inducing relaxation, it has no effect on the course of MS. A 1998 study investigated the effect of massage in people with MS on:
  • relief of anxiety and depression 
  • improvement in mood, self-esteem and body image 
  • increased ambulation and improved physical and social functioning. 
The study used self-reports by the participants and found that, at the end of a five-week period, physical and social activity had improved in the people receiving massage. Those in the massage group also reported a decrease in depression. There was, however, no improvement in grip strength and only marginal improvement in ambulation." 
So, keep up the massage and add some strength training or yoga to keep those muscles strong!

Lance Armstrong's talks about the benefits of massage on pain in MS sufferers. By reducing pain, massage can help folks become more mobile. Less pain = more movement. Folks withnMS don't want to be in bed. Sometimes we don't have much choice.

Massage & Bodyworks Magazine has done their research with regards to MS and massage presenting us with one of the most comprehensive yet simple to digest articles summarizing MS, the disease, along with the benefits of massage.
"For the MS patient, a well-being approach for addressing body, mind, and spirit is essential to combating the effects of the disease. Helpful self-care can include a daily routine of tai chi or yoga, meditation, and attention to diet." 
They get it. They get the disease and seem to understand what we need to feel better.

Many therapists, especially in the Northwest where prevalence is higher, jphave numerous MS clients. Crowell is one of them:
"With her extensive MS experience, Crowell says she has learned the importance of balance between releasing spasticity and maintaining enough tone for the client to function. “If you relax someone with MS too much, they can’t walk when they get off the table. They use the spasticity to keep them erect.” By implementing a reflex response technique, she reduces spasms without decreasing tone. The client is better able to maintain standing balance, and for those who are not ambulatory, core stability is increased so they can sit better. “One of the things people tend to lose is control. You are working with refining the amount of contraction they use with a given movement."
Wow! This is some great stuff. A must read for all with multiple sclerosis.

The American Academy of Neurology talks about the most common massage techniques used for reducing pain in MS patients:
  • Craniosacral massage: Light pressure is applied to the head, neck, and spine to ease tension and compression. This type of massage is not appropriate for people with conditions that could be affected by intracranial pressure changes, such as acute aneurysm, cerebral hemorrhage, or hydrocephaly. 
  • Lymphatic massage: Light, rhythmic strokes are used to improve the flow of lymph (a colorless fluid that helps fight infection and disease) and get rid of waste throughout the body. Lymphatic massage is often used to reduce post-surgical swelling and to help heal sports-related injuries. 
  • Myofascial release: Pressure and body positioning are used to loosen and stretch the muscles, fascia (connective tissue), and related structures. Both physical therapists and massage therapists who are appropriately trained use this technique.
  • Reflexology: Specialized thumb and finger techniques are applied to reflex points in the hands and/or feet. 
  • Shiatsu: Gentle finger and hand pressure are applied to specific points on the body to relieve pain. 
  • Swedish massage: A variety of strokes and light-pressure techniques are used to enhance blood flow, remove waste products from tissues, stretch ligaments and tendons, and ease physical and emotional tension. 
  • Trigger point massage: Pressure is applied to trigger points (tender areas where the muscles have been damaged or where tension accumulates) to alleviate muscle spasms and pain. 
One of my favorites? Lymphatic can feel the toxins being squeegeed out of you! But I love them all. In fact, I'm off to get one now! What's your experience? Pro massage or toss it?

This concludes the 124th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on October 11, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, October 9, 2012.

Thank you.

Saturday, September 22, 2012

Cognitive Reframing and Stress Reduction

When faced with stress, effective coping skills are your way to staying above the fray.  Stress itself is not necessarily bad.  But an individual's perception and respond to a stressful event is very important.

General stress management techniques include: eating a balanced healthy diet; keeping physically, socially and intellectually active; taking prescribed medications as directed; getting adequate amounts of sleep; and resting if fatigued.  Strive for cardiovascular health.

Maintain a sense of humor and positive attitude.  Be aware of lifestyle habits that can negatively impact your physical and mental health.  Take advantage of cognitive and/or physical aids and strategies when needed.  Cognitive reframing can be one of the most effective stress management techniques available.

Read this post in its entirety:

Stress and MS: Cognitive Reframing and Stress Reduction

Wednesday, September 19, 2012

Stress and MS: The Mind-Body Connection

Stress is not an inherently bad thing, however if you have MS, you know that it can have negative effects. For years, the connection between stress and MS has been accepted by neurologists, neuropsychologists, and patients alike.  I agree that acute stress seems to aggravate my MS symptoms.

Saturday morning, I attended an MS Women’s Breakfast sponsored by the local chapter of the National MS Society.  The guest speaker was Mary Elizabeth Quig, Ph.D., clinical neuropsychologist at Georgetown University MS Center and founding partner at Neuropsychology Associates of Fairfax.  The title of her presentation was “Dames who Reframe.”

Dr. Quig began her presentation discussing neuropsychology, stress, and psychoneuroimmunology (PNI).  Psychoneuroimmunology takes an interdisciplinary approach to the study of the interaction between mental processes, the nervous system, and the immune system.  It offers a scientific study of the Mind-Body connection.

Read this post in its entirety:

Stress and MS: The Mind-Body Connection

Thursday, September 13, 2012

Carnival of MS Bloggers #123

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

FDA Approves MS Pill, MS Inconvenience, 
and Anti-inflammatory Foods to Help MS

from Lisa Emrich of Brass and Ivory: Life with MS and RA 

Late Wednesday afternoon, the FDA announced that Aubagio (teriflunomide) has been approved for adults with relapsing forms of MS.  Click through to the original blog post to find the FDA announcement, a Reuters news report, abstracts for 12 academic studies published between 2006 and 2012 regarding teriflunomide and oral medications in development for MS, and the Genzyme press release regarding the FDA approval of Aubagio (teriflunomide).

from Stax of Multiple Sclerosis & Me

i hate being sick; having MS!!

that's all; no funny stories, no lamenting or feeling sorry for myself. i just hate it; it's a pain in my ass and a big inconvenience.

from The Girl With MS 

Nutrition will allow you to Thrive with MS! Anyone with MS should know what cooling foods are and how they affect the body and the disease.

My research began over ten years ago. Three different Chinese medicine doctors diagnosed me as being kidney yen deficient. While investigating what these doctors were telling me, I found that many of the symptoms for this 5,000 year old Chinese disease were shockingly similar to that of modern day MS and many autoimmune diseases for that matter.

When asked about the cause the Chinese doctors all responded with "Western diet and lifestyle". The Western diet contains many processed and falsely seasoned foods not to mention excess fat. Western people are known to skip meals, eat on the hoof and gorge on salte, fat and sweets with no care about their bodies.

According to Chiness Medicine there are different kinds of food: cool, neutral and heating. Depending upon our makeup and health dictates which foods are best. For an inflamed person with MS the cooling foods are desired.

(FYI - Chinese Medicine offers much more than discussed here where it's been crudely simplified. Resources linked below)

So what foods cool off the body and help my MS?

Some obvious food such as cucumbers come to mind. Apples, bananas, citrus, clams and many more. But what about sushi? Have you ever eaten the eel? Unagi? One summer there was a heat wave in Japan and a subsequent shortage of Unagi due to its cooking effect on the body.

Imagine using foods to cool off and saving that electricity bill!

Information about cooling foods and nutrition for MS has grown significantly these
past ten years. Here are some places to check out:

A good primer on Chinese Medicine and food classifications

Spreadsheet of foods by class from DocStock

Heating vs Cooling Foods. A review

Food as Medicine - a look into Chinese Medicine. (downloadable PDF)

Chinese Food Pyramid for Dogs and More

Nutrition will allow you to Thrive with MS!

This concludes the 123rd edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on September 27, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, September 25, 2012.

Thank you.

Wednesday, September 12, 2012

FDA approves oral drug, Aubagio (teriflunomide), for treatment of Relapsing MS

Late Wednesday afternoon, the FDA announced that Aubagio (teriflunomide) has been approved for adults with relapsing forms of MS.  Below you will find the FDA announcement, a Reuters news report, abstracts for 12 academic studies published between 2006 and 2012 regarding teriflunomide and oral medications in development for MS, and the Genzyme press release regarding the FDA approval of Aubagio (teriflunomide).

As I am the type of researcher/reader who likes to have easy access to complete information in one place.  I thought that you might appreciate the following collection of abstracts/links.  Many of the studies are open access (meaning you do not have to pay for access) and downloadable.  I have a few pdf copies of ones which are not open access, published in the Multiple Sclerosis Journal.

Scroll down to the bottom of this post to read Genzyme's announcement which includes the introduction of their MS One to One™ program.  Update: Aubagio will be priced at $45,000


September 12, 2012 – The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.

The drug contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.

Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.

Aubagio will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Aubagio is made by Bridgewater, N.J.-based Sanofi Aventis.


(Reuters) – September 12, 2012 – Sanofi's multiple sclerosis pill, Aubagio, is set to reach the U.S. market, after the Food and Drug Administration gave a green light on Wednesday.

Aubagio is one of the two multiple sclerosis treatments the French drugmaker is relying on to return to growth after the loss of several blockbuster drugs to generic rivals.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Russell Katz, director of the Division of Neurology Products at the FDA, said in a statement posted on the drug regulator's website.

The European regulator is expected to give its response on Aubagio in the first quarter of 2013.

Compared with older therapies for MS, Aubagio has the advantage of being an oral drug.

But it has produced less impressive results in clinical tests than other oral treatments and has failed to show it was better than Merck's Rebif, a commonly used injectable drug for MS, although Aubagio has milder side effects.

Analysts expect the drug could find favor among newly diagnosed patients, since around 35 percent to 40 percent of MS patients prefer to take no medication rather than face unwanted side effects.

MS pills Gilenya by Novartis and Biogen Idec Inc's BG-12 are seen dominating a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year.

Aubagio is seen grabbing a much smaller chunk of this market, reaching modest sales of $353 million in the United States and five major European countries by 2020, according to business intelligence firm Datamonitor.

Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

In addition to Aubagio, Sanofi has filed MS injectable drug Lemtrada with regulators.

Despite a recent setback at the FDA, when the regulator asked Sanofi to refile its marketing application for the drug, Lemtrada could be launched in 2013 if it wins approval.


Miller AE, O'Connor P, et al. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosisMult Scler. 2012 Jun 21. [Epub ahead of print]

BACKGROUND: The Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), disease progression and magnetic resonance imaging (MRI) activity, with a favorable safety profile in relapsing multiple sclerosis (RMS) patients.Objective:The purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.
METHODS: RMS patients (n=1088) were randomized to placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks. Subgroup analyses were performed for ARR and disability progression by baseline demographics (gender, race, age), disease characteristics (Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis (MS) subtype), MRI parameters (gadolinium-enhancing lesions, total lesion volume) and prior use of MS drugs. A generalized estimating equation method and Cox regression model were used to assess consistency of the treatment effect across subgroups, utilizing a treatment-by-subgroup interaction test for each factor separately.

RESULTS: Reductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.

CONCLUSION: The positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.


Freedman MS, Wolinsky JS, et al. Teriflunomide added to interferon-β in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. Epub 2012 May 23.

OBJECTIVE: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-β (IFNβ) in patients with relapsing forms of multiple sclerosis (RMS).
METHODS: A total of 118 patients with RMS were randomly assigned 1:1:1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 patients entered the 24-week extension. The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate.

RESULTS: Teriflunomide was well tolerated with a low and similar incidence of treatment-emergent adverse events (TEAEs) across the 3 groups; TEAEs led to treatment discontinuation of 4.9%, 8.1%, and 7.9% of patients in the placebo, 7-mg, and 14-mg groups, respectively. The number of gadolinium-enhancing T1 (T1-Gd) lesions was reduced in both teriflunomide groups, with relative risk reductions (RRRs) of 84.6% (p = 0.0005) and 82.8% (p < 0.0001) for 7 and 14 mg, respectively, compared with IFNβ alone at 48 weeks. T1-Gd lesion volume was also reduced in the 7-mg group (RRR 72.1%, p = 0.1104) and 14-mg group (RRR 70.6%, p = 0.0154). A trend toward dose-dependent reduction in annualized relapse rate was also noted (RRRs 32.6% [p = 0.4355] and 57.9% [p = 0.1005] for 7 and 14 mg, respectively).

CONCLUSION: Teriflunomide as add-on therapy to IFNβ had acceptable safety and tolerability and reduced MRI disease activity compared with IFNβ alone.

Classification of evidence: This study provides Class II evidence that teriflunomide, 7 and 14 mg, added to IFNβ, is safe. The T1-Gd lesion burden was significantly reduced with both teriflunomide doses.


Confavreux C, Li DK, et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-1289. Epub 2012 Feb 3.

BACKGROUND: Teriflunomide, an oral disease-modifying therapy in development for patients with relapsing forms of multiple sclerosis (RMS), was well tolerated and effective in reducing magnetic resonance imaging (MRI) lesions in 179 RMS patients in a phase 2 36-week, placebo-controlled study.

METHODS: A total of 147 patients who completed the core study entered an open-label extension. Teriflunomide patients continued their assigned dose, and placebo patients were re-allocated to teriflunomide, 7 mg/day or 14 mg/day. An interim analysis was performed at a cut-off on January 8 2010.

RESULTS: The mean and median duration of study treatment, including both the core and extension phase, from baseline to the interim cut-off, was 5.6 years (standard deviation: 2.7 years) and 7.1 years (range: 0.05-8.5 years), respectively. Of 147 patients, 62 (42.2%) discontinued (19% due to treatment-emergent adverse events (TEAEs)). The most common TEAEs were mild infections, fatigue, sensory disturbances and diarrhoea. No serious opportunistic infections occurred, with no discontinuations due to infection. Asymptomatic alanine aminotransferase increases (≤3× upper limit of normal (ULN)) were common (7 mg, 64.2%; 14 mg, 62.1%); increases >3×ULN were similar across groups (7 mg, 12.3%; 14 mg, 12.1%). Mild decreases in neutrophil counts occurred; none led to discontinuation. The incidence of malignancies was comparable to that of the general population, and cases were not reminiscent of those observed in immunocompromised patients. Annualised relapse rates remained low, minimal disability progression was observed, with a dose-dependent benefit with teriflunomide 14 mg for several MRI parameters.

CONCLUSION: Teriflunomide had a favourable safety profile for up to 8.5 years.


Killestein J, Rudick RA, Polman CH. Oral treatment for multiple sclerosis. Lancet Neurol. 2011 Nov;10(11):1026-34.

BACKGROUND: The armamentarium for the treatment of relapsing-remitting multiple sclerosis (RRMS) is increasing rapidly. Several oral treatments have shown benefit and will generate much interest because of the convenience of such administration. However, availability of convenient oral drugs will not necessarily translate into clinical effectiveness and safety. Here, we provide an interim report about the mechanisms of action, and efficacy and safety results that have been reported since January, 2010, for five new oral drugs. Additionally, we draw attention to issues that neurologists and patients will encounter when considering the use of new oral drugs.
RECENT DEVELOPMENTS: Positive results have been reported for five new oral drugs for RRMS--fingolimod, cladribine, teriflunomide, laquinimod, and dimethyl fumarate--in phase 3 studies; a few new oral drugs are likely to be approved for RRMS soon.

WHERE NEXT?: Emerging oral treatments are ushering in a new era in the treatment of MS, providing not only new treatment options but also new challenges. Since data for some of the new drugs have not been reported in peer-reviewed journals yet and safety profiles are not yet fully developed, opinions about the use of these new oral drugs in practice are preliminary and tentative. Practice will evolve with time as information and experience accumulates. Of importance will be results from comparator trials, information about management of patients with breakthrough disease, results from long-term safety studies, and results of studies to assess the potential for neuroprotective effects of the new drugs.


O'Connor P, Wolinsky JS, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303.

BACKGROUND: Teriflunomide is a new oral disease-modifying therapy for relapsing forms of multiple sclerosis.

METHODS: We concluded a randomized trial involving 1088 patients with multiple sclerosis, 18 to 55 years of age, with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least one relapse in the previous year or at least two relapses in the previous 2 years. Patients were randomly assigned (in a 1:1:1 ratio) to placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks.

RESULTS: Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P=0.001 for both comparisons with placebo). The proportion of patients with confirmed disability progression was 27.3% with placebo, 21.7% with teriflunomide at 7 mg (P = 0.08), and 20.2% with teriflunomide at 14 mg (P = 0.03). Both teriflunomide doses were superior to placebo on a range of end points measured by
magnetic resonance imaging (MRI). Diarrhea, nausea, and hair thinning were more
common with teriflunomide than with placebo. The incidence of elevated alanine
aminotransferase levels (≥1 times the upper limit of the normal range) was higher
with teriflunomide at 7 mg and 14 mg (54.0% and 57.3%, respectively) than with
placebo (35.9%); the incidence of levels that were at least 3 times the upper limit of
the normal range was similar in the lower- and higher-dose teriflunomide groups
and the placebo group (6.3%, 6.7%, and 6.7%, respectively). Serious infections were
reported in 1.6%, 2.5%, and 2.2% of patients in the three groups, respectively. No
deaths occurred.

CONCLUSIONS: Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo.

(Funded by Sanofi-Aventis; TEMSO number, NCT00134563.).


Nicholas R, Giannetti P, et al. Development of oral immunomodulatory agents in the management of multiple sclerosis. Drug Des Devel Ther. 2011;5:255-74. Epub 2011 May 10.

Abstract: The emergence of oral disease-modifying therapies in multiple sclerosis (MS) will have a significant impact on the evolving scenario of immunomodulatory treatments in MS where current therapies are all injectable. Reducing relapses in trials translates for individuals with MS into a therapeutic aim of stopping future events. Thus the possible absence of any perceived benefits to the individual together with the long disease course, variable outcome, and a younger age group affected in MS makes side effects the major issue. The use of disease-modifying therapies as a whole needs to be placed in the context of a widening therapeutic indication where the use of these therapies is being justified at an increasingly early stage and in pre-MS syndromes such as clinically isolated and radiologically isolated syndromes where no fixed disability is likely to have accumulated. The five oral therapies discussed (cladribine, fingolimod, laquinimod, BG-12, and teriflunomide) have just completed Phase III studies and some have just been licensed. New oral drugs for MS need to be placed within this evolving marketplace where ease of delivery together with efficacy and side effects needs to be balanced against the known issues but also the known long-term safety of standard injectables.


Krieger S. Multiple sclerosis therapeutic pipeline: opportunities and challenges. Mt Sinai J Med. 2011 Mar-Apr;78(2):192-206. doi: 10.1002/msj.20241.

Abstract: The year 2010 marked the beginning of the era of oral medications for the treatment of multiple sclerosis, with the approval of dalfampridine to improve walking and fingolimod as the first oral disease-modifying agent. This review provides an overview of these and other emerging therapies, with an emphasis on the opportunities for new treatment paradigms they have the potential to offer, followed by a discussion of the challenges they will pose in the new era of multiple sclerosis management. Therapeutics in late-stage development for MS include non-selective immunosupressants, targeted immune-modulators, and monoclonal antibodies. Oral agents including cladribine, teriflunomide, laquinimod, and dimethyl fumarate, as well as monoclonal antibodies alemtuzumab, daclizumab, and rituximab are considered. Potential side effects and adverse event monitoring, including opportunistic infections, emergent malignancies, and other systemic consequences of immunosuppression are discussed in a unified section. Challenges of optimally staging, sequencing, and combining treatments in the expanding multiple sclerosis armamentarium are discussed. This review emphasizes the multifactorial decision making that these new therapeutics will warrant in terms of patient selection and personalization/individualization of therapy, and the increasingly interdisciplinary approach that will be necessitated by the new generation of agents.


Jadidi-Niaragh F, Mirshafiey A. Therapeutic approach to multiple sclerosis by novel oral drug. Recent Pat Inflamm Allergy Drug Discov. 2011 Jan;5(1):66-80.

Abstract: Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system and the most common cause of neurological disability in young adults, along with a considerable clinical and pathological heterogeneity. Since, current therapies appear to be modest in the magnitude of their treatment effects, particularly in the progressive phase of this disease, thus novel promising therapeutic strategies might open a light horizon in approaching to an efficient treatment in MS. In this review, we will discuss about relevant patents and novel designed immunosuppressive and anti-inflammatory oral drugs promising for treatment of multiple sclerosis.


Palmer AM. Teriflunomide, an inhibitor of dihydroorotate dehydrogenase for the potential oral treatment of multiple sclerosis. Curr Opin Investig Drugs. 2010 Nov;11(11):1313-23.

Abstract: Teriflunomide, being developed as a potential oral treatment for multiple sclerosis (MS) by sanofi-aventis, is the active metabolite of the rheumatoid arthritis drug leflunomide. Both teriflunomide and leflunomide are inhibitors of the mitochondrial enzyme dihydroorotate dehydrogenase, which is critically involved in pyrimidine synthesis. The production of activated T-cells largely depends on de novo pyrimidine synthesis, and thus pyrimidine depletion is thought to result in the inhibition of immune cell proliferation. Therapeutic efficacy of teriflunomide has been demonstrated in vivo in an experimental autoimmune encephalomyelitis model of MS using Dark Agouti rats. In a phase II, randomized, double-blind, placebo-controlled clinical trial of patients with relapsing-remitting MS, treatment with teriflunomide reduced the number of active lesions in the brain and preliminary evidence indicated a slowing in the development of disability. Recently reported data from the phase III TEMSO clinical trial support these initial findings. Compared with current therapies, teriflunomide has the advantage of oral administration. Thus, if good efficacy is demonstrated, teriflunomide may have a role to play in the future treatment of MS.


Barten LJ, Allington DR, et al. New approaches in the management of multiple sclerosis. Drug Des Devel Ther. 2010 Nov 24;4:343-66.

Abstract: Multiple sclerosis (MS) is a central nervous system chronic inflammatory disease that is characterized by an extensive and complex immune response. Scientific advances have occurred in immunology, pathophysiology, and diagnostic and clinical assessment tools, and recent discovery of unique therapeutic targets has spurred numerous Phase II and Phase III clinical trials. Reductions in MS relapse rates and improvements in T₂ or gadolinium-enhancing lesion burdens have been reported from Phase III trials that include fingolimod, alemtuzumab, cladribine, and rituximab. Promising Phase II trial data exist for teriflunomide, daclizumab, laquinimod, and fumarate. The optimism created by these favorable findings must be tempered with evaluation of the adverse effect profile produced by these new agents. Given the discovery of progressive multifocal leukoencephalopathy with the use of natalizumab, ongoing vigilance for rare and life-threatening reactions due to new agents should be paramount. Patients with MS often experience difficulty with ambulation, spasticity, and cognition. Recent clinical trial data from two Phase III dalfampridine-SR trials indicate certain patients receive benefits in ambulation. This article provides an overview of data from clinical trials of newer agents of potential benefit in MS.


Warnke C, Meyer zu Hörst G, et al. Review of teriflunomide and its potential in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2009;5:333-40. Epub 2009 Jun 10.

Abstract: In the light of new cases of progressive multifocal leukoencephalopathy and induced autoimmunity in multiple sclerosis (MS) patients who received treatment with upcoming disease-modifying immunosuppressant drugs with a highly specific mode of action such as natalizumab, rituximab, or alemtuzumab, alternative oral treatment options for a subgroup of less severely affected MS patients are a major focus of drug development. These agents are currently investigated in phase III clinical trials and some of them are characterized by a favorable safety profile. With an emphasis on teriflunomide, the active metabolite of an immunosuppressant approved for the treatment of rheumatoid arthritis since 1998, a number of oral treatment options for patients with MS are discussed.


O'Connor PW, Li D, et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900.

BACKGROUND: Teriflunomide, a dihydro-orotate dehydrogenase inhibitor, has immunomodulatory effects, including the ability to suppress experimental allergic encephalomyelitis. In this randomized, double-blind, placebo-controlled Phase II study, the authors examined the safety and efficacy of oral teriflunomide in multiple sclerosis (MS) with relapses.

METHODS: Patients (n = 179) with relapsing-remitting MS (n = 157) or secondary progressive MS with relapses (n = 22) were randomized to receive placebo, teriflunomide 7 mg/day, or teriflunomide 14 mg/day for 36 weeks. MRI brain scans were performed every 6 weeks. The primary endpoint was the number of combined unique active lesions per MRI scan. Secondary endpoints included MRI-defined disease burden, relapse frequency, and disability increase.

RESULTS: The median number of combined unique active lesions per scan was 0.5, 0.2, and 0.3 in the placebo, teriflunomide 7 mg/day (p < 0.03 vs placebo), and teriflunomide 14 mg/day (p < 0.01 vs placebo) groups during the 36-week double-blind treatment phase. Teriflunomide-treated patients also had significantly fewer T1 enhancing lesions per scan, new or enlarging T2 lesions per scan, and new T2 lesions. Patients receiving teriflunomide 14 mg/day had significantly reduced T2 disease burden. Teriflunomide treatment resulted in trends toward a lower annualized relapse rate and fewer relapsing patients (14 mg/day only) vs placebo. Significantly fewer patients receiving teriflunomide 14 mg/day vs placebo demonstrated disability increase. Treatment was well tolerated; numbers of adverse events and serious adverse events were similar in all treatment groups.

CONCLUSION: Oral teriflunomide was effective in reducing MRI lesions and was well tolerated in patients with relapsing multiple sclerosis.


FDA Approves Genzyme’s AUBAGIO® (teriflunomide),
a Once-Daily, Oral Treatment for Relapsing Multiple Sclerosis

CAMBRIDGE, Mass. – September 12, 2012 – Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

“We are very excited to introduce AUBAGIO as a new treatment option that can make a difference in the lives of people with multiple sclerosis,” said David Meeker, President and CEO, Genzyme. “The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community.”

The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial.

“Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. “The FDA’s approval of AUBAGIO, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”

The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“We are greatly encouraged to see a new oral therapeutic option become available to people living with MS,” said Dr. Timothy Coetzee, Chief Research Officer at the National MS Society. “With collaborative research underway around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS.”

The AUBAGIO label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).

In MS clinical studies with AUBAGIO, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with AUBAGIO in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.

The labeling for AUBAGIO was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

Please click here for full Prescribing Information for once-daily oral AUBAGIO (teriflunomide), including boxed warning and contraindications, for treatment of Relapsing Multiple Sclerosis.

The AUBAGIO clinical development program in MS also included the recently reported TOWER study. TOWER assessed the efficacy and safety of once-daily, oral AUBAGIO in patients with relapsing forms of multiple sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of disability progression. In addition, a significant reduction in annualized relapse rate was observed in patients treated with teriflunomide 7 mg compared to placebo. Adverse events observed in the trial were consistent with previous clinical trials with teriflunomide in MS. Analysis of the full TOWER data is ongoing and results will be presented at a forthcoming scientific meeting.

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

As part of its commitment to MS patients, Genzyme has developed the MS One to One™ program. MS One to One provides information about multiple sclerosis, AUBAGIO and other relevant resources and is available and staffed by dedicated MS nurses and highly trained representatives who can provide support for individuals living with MS, their health care providers, family and loved ones. For more information about these support services, call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) Monday through Friday, from 8:30 a.m. to 8:00 p.m. ET. Information and support are also available at

Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.

Learn more at


September 12, 2012 | By John Carroll

Sanofi ($SNY) won a badly needed FDA approval Wednesday for its oral multiple sclerosis drug Aubagio (teriflunomide). And soon after the news hit a representative for Sanofi subsidiary Genzyme said that the MS treatment will be priced at $45,000 a year, angling in to grab market share.

"The price of Copaxone is 7% more," the rep added. "The price of Avonex is 8% more and the price of Gilenya is 28% more than the price of Aubagio." The new treatment was filed for approval by Sanofi's biologics arm, Genzyme, which will now handle the marketing.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," commended Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

"We'll stack up quite well with what's out there," David Meeker, the CEO at Genzyme, tells FierceBiotech. All of the drugs available carry warnings about significant side effects. And the injectables on the market present an added burden for the population that oral drugs can eliminate.

"I do predict movement," he added about the patients and physicians considering treatment regimens. "There's going to be a significantly increased willingness to try new things." And after Lemtrada makes it through the approval process on MS, where it's given a good shot at an approval, the Genzyme MS franchise will grow. "These new drugs will be highly complementary, providing meaningful choices."

For Sanofi, the agency's approval marks a key win after a lengthy drought of new approvals. In the next step, Sanofi will work to steal a march on Biogen Idec ($BIIB), which has won the spotlight on MS with its experimental MS drug BG-12. The Aubagio program, which was transferred over to its biologics arm Genzyme as it seeks an OK on Lemtrada as well, failed to beat out the injectable Rebif. The key challenge here, though, will be Aubagio's ability to gain market share among new oral therapies. But some analysts aren't hopeful that the newly approved treatment can come close to blockbuster status.

"We doubt the drug will seriously affect Gilenya or Tysabri, where prescriptions are largely driven by efficacy," Berenberg Bank's Alastair Campbell told Bloomberg. Datamonitor assessed peak sales at just a little above $350 million for the top global commercial markets, according to a report from Reuters.

The approval will bolster CEO Chris Viehbacher as he continues to push a big shakeup on the R&D side of the business. But it may not be welcomed by the company's French employees, who are staging a strike today to protest deep cuts anticipated for the European side of the operation.

R&D hasn't always been easy at Sanofi. Weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators handed the NDA back, telling the biologics arm of Sanofi that it needs to complete a rewrite before they can properly assess it. But the Aubagio sign-off follows an important approval for its cancer division. Just days ago Sanofi got its first green light for Zaltrap, a cancer drug developed with Regeneron ($REGN). It's a second-line approval, in a market already dominated by Roche's ($RHHBY) Avastin and Bristol-Myers Squibb's ($BMY) Erbitux. But it's a step forward after a couple of oncology setbacks--and a first step toward hundreds of millions in sales.

Saturday, September 8, 2012

Famous Birthdays, September 7

Yesterday was my birthday, and today, I learned that it had been Muffie's birthday as well.  Happy birthday!!

It is always cool to discover that you share a birthday with someone.  The following famous and significant figures also share our day.  Seems like September 7 was a good day for monarchs, politicians, artists, composers, singers, and cartoon character voices.

Of course, it's really neat to share a birthday with Queen Elizabeth I, Grandma Moses, Garrison Keillor, and Buddy Holly.  But I was most excited to learn that I share the day with the famous Heinrich Stölzel, horn player and one of the inventors of brass instrument valves!  How cool is that?!!

Monarchy, Military, Politicians:
English Monarch Queen Elizabeth I
Queen Elizabeth I of England
 ‧ Emperor Saga, 52nd Emperor of Japan (786-842) ‧ Louis II (1438-1471, Landgrave of Hesse) ‧ Frederik I (1471, King of Denmark/Norway (1523-33)) ‧ Thomas Erastus (1524-1583, Swiss theologian) ‧ Queen Elizabeth I (1533-1603, Greenwich, Queen of England (1558-1603), daughter of Henry VIII and Anna Boleyn (d. 1603)) ‧ Ernest Augustus (1674-1728) ‧ Mary Anne of Austria (1683-1754, Archduchess of Austria and Queen consort of Portugal) ‧ Bernardus JC Dibbets (1782, Dutch baron/general-major (Maastricht) ‧ William Hamsley Emory (1811-1887, Major General (Union volunteers)) ‧ Howell Cobb II (1815-1868, Major General/Secy of Treas (Union)) ‧ Louise of Hesse-Kassel (or Hesse-Cassel) (1817-1898, Queen of Denmark) ‧ Thomas Talbot (1818-1886, 31st Governor of Massachusetts) ‧ Henry Campbell-Bannerman (1836, British PM (L) (1905-08)) ‧ Willem H Nolens (1860, priest/Dutch ambassador to Vatican) ‧ Baudouin I (1930, King of Belgium (1951-93) ‧ Omar Karami (1934, Prime Minister of Lebanon) ‧ Abdou Diouf (1935, President of Senegal (1981- )) ‧ Beverley McLachlin (1943, Chief Justice of Canada) ‧

Artists, Entertainers, Cartoon Voices:
Primitive Painter Grandma Moses
Grandma Moses, painter
‧ Grandma Moses [Anna Maria] (1860-1961, NY, primitive painter (Old Oaken Bucket)) ‧ Don Messick (1927, Buffalo NY, cartoon voice (Bam-bam, Astro-Jetsons, Scooby-Doo)) ‧ Garrison Keillor (1942, humorist (Praire Home Companion)) ‧ Julie Kavner (1951, LA California, actress (Brenda-Rhoda, Marge-Simpsons)) ‧

‧ Clemens Thieme (1631) ‧ Pal Esterhazy (1635) ‧ Jean Monnet (1703) ‧ Francois-Andre Danican Philidor (1726, France, also chess champion) ‧ Damasus Brosmann (1731), Elisabetta de Gambarini (1731) ‧ Joseph Legros (1739) ‧ Frantisek Max Knize (1784),  Giovanni Tebaldini (1864) ‧ Attilio Brugnoli (1880) ‧ Kurt von Wolfurt (1880) ‧ Filip Gershkovich (1906) ‧ Ahmet Adnan Saygun (1907) ‧ Hugo Pfister (1914) ‧ Graeme Bell (1914, Australian pianist and composer) ‧ Kirill Vladimirovich Molchanov (1922) ‧ Hugh Aitken (1924) ‧ Graham Dudley Whettam (1927) ‧ Charles Camilleri (1931) ‧ Romualds Kalsons (1936) ‧ Olly Wilson (1937) ‧ Mark Isham (1951) ‧ Michael Byron (1953) ‧

Musicians, Singers, Song-writers:
Horn with Stölzel Valves
‧ Heinrich Stölzel (1777-1844, German musician, horn player, early valve designer, composer, and "inventor of the modern valve trumpet") ‧ Lena Valaitis (1943, Lithuanian-German Schlager singer) ‧ Max Kaminsky (1908, trumpeter) ‧ Jo Juda (1909, Dutch musician) ‧ Natalia Dmitrevna Shpiller (1909, singer) ‧ Al Caiola (1920, American guitarist) ‧ Arthur Ferrante (1922, pianist/composer (Ferrante & Tachere-Exodus)) ‧ Bridie Gallagher (1924-2012, Donegal, Ireland, singer (A Mother's Love's A Blessing, The Boys from County Armagh)) ‧ Sonny Rollins (1930, NYC, jazz saxophonist (Blue Room)) ‧ Little Milton (1934-2005, American musician) ‧ Buddy Holly (1936-1959, Lubbock TX, singer (Peggy Sue, That'll Be the Day)) ‧ Luis Aravena Munoz (1945, Chilean singer/exiled in Netherlands) ‧ Alfa Anderson (1946, Bronx NY, rock vocalist (Chicago)) ‧ Gloria Gaynor (1949, Newark NJ, disco singer (I Will Survive)) ‧ Chrissie Hynde (1951, Akron OH, rocker (Pretenders-Mystery Achievement)) ‧ Morris Albert (1951, Brazilian singer) ‧ Ben Bossi (1953, rocker (Romeo Void)) ‧ Benmont Tench (1954, Gainesville FL, rock keyboardist (Heartbreakers)) ‧ Michael J Feinstein (1956, pianist (Isn't It Romantic)) ‧ Diane Warren (1956, American song writer) ‧ Margot Chapman (1957, Hawaii, vocals (Starland Vocal Band-Afternoon Delight)) ‧ Nadieh (1958, Dutch singer/guitarist/composer (Haifa Blue)) ‧ Jermaine Stewart (1959, rocker) ‧ David Steele (1960, Birmingham AL, rock keyboardist (Fine Young Cannibals)) ‧ LeRoi Moore (1961-2008, American Saxophonist (Dave Matthews Band)) ‧ Jean-Yves Thibaudet (1961, French Pianist) ‧ Eric Eazy-E Wright (1963, rapper) ‧ Christopher Acland (1966, musician) ‧ Kyle Stevens (1968, NJ, rock guitarist (Bang Tango-Dancin' on Coals)) ‧ Little Jimmy Urine (1969, American singer (Mindless Self Indulgence)) ‧ Paul McCoy (1981, American musician (lead singer of 12 Stones)) ‧ Spectacular Blue Smith (1986, American musician (Pretty Ricky)) ‧

Wednesday, September 5, 2012

Carnival of MS Bloggers #122

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Sleep Disorders, MS, and Multipurpose Sticks

from Thomas of BiPolar, MS and still as handsome as ever 

Take a look at this picture:

On the left you see a very dilapidated golf club, a one iron of some
ancient make probably used by the Morris clan (golf joke) and left in a garage sale.  The paint wasn't on there originally.  Just an added touch to being stuck in a garage by a guy who found that he could not play golf, but could hit a ball with a stick and follow it around.  I just didn't feel the need to pay some stranger for the use of their land to hit the little ball and follow it around privileges.

The club has a MS use though.  A few times a week I grab the club, stand in the grass, assume the position, and take a good swing.  If I remain standing, its a good day.  If I come down goofy or start to tumble, this is not a good day and I should be careful.  So while my one iron and its friends in the bag sitting in my garage may never see a golf course again, they do remind me of another day when I could freely play a sport I sucked at.

Now as for the stick in the middle of the photo, that's my new walking stick.  On Friday, Jackie and I went to the Southern Vermont Craft Fair in Manchester, Vermont.  This has been a tradition for many years and we'd stay at local B & B's and go to the Craft Fair at the rolling lawns of Hildene, the former home of Robert Todd Lincoln and his family.  Highly recommended. Well, the bed and breakfasts closed.  And this year the Craft Fair moved to the other side of Manchester.  Ch-ch-ch-ch-changes, said Mr. Bowie.

Time to turn and face the strain.  The Craft Fair is in the midst of a field, a Vermont field, meaning rocks and little gullies and tiny holes, and if you have any problem with coordination, and I believe lots of MSers do, here was a challenge.  If I held my wife's hand I could move pretty well, going from booth to booth, but the moment she stopped to look at jewelry or whatever and I continued on my own, any quick turn or "excuse me" step out of the way might send me reeling into any booth anywhere, and I'd find myself staring at a piece of crockery that would only set me back three hundred bucks.  I'd mumble some excuse like - "Astounding work. I must remind the Queen." - and move along, find Jackie and head out.

We got a drink and hit the food tent where free samples were distributed.  My favorite was the rye whiskey (butterscotch in a paper shot cup).  When we left the food tent, we headed out to the tents off to themselves on the other side of the field.  There was the temporary abode of Debi Hitter, purveyor of custom made walking sticks (Eagle Scout sticks a specialty).  I ended up with one of the those sticks, and used it successfully to move around the craft with slightly more balance.  The stick also opens up new possibilities for career options:

1. Religious leader  (i.e. Moses) - see the staff in his right hand - by the way, the statue is in Washington Park in Albany NY, and this shot was taken during the Tulip Festival held each May.  Let's see, I might  ask my former employer to "let my people go", but they would, and then try and run the Department of Social Services with trained monkeys  (a lot easier to pass out bananas than support).  And where would I lead my people anyway? Across the street for lunch? The parking lot?

2. Robin Hood - there's that scene in every Robin Hood movie and parody from Mel Brooks to Daffy Duck where Robin and Little John parry with quarterstaffs, like this. See maybe I could become the local Jedi Knight for the Luther Forest area.  There must be an opening somewhere.  I know my first enemy, the chipmunks in the back yard. 

I figure a swing or two with my new Jedi stick (I can make the noises) and those little buggers will head off into the Endor forests.

3. Join one of those German groups with the leiderhosen, and the sticks with the jingle bells on them, but I'd probably be asleep in my chair by the second song, so never mind.

I'll try to come up with other stick uses (open for suggestions).  Right now I'll use it on tough walking days.  It's better than a wheelchair.  It's a reminder that tough days may be ahead, but I can handle them in style.  The lady who made the stick is also interested in providing others to the MS group.

From the update pile: I've got appointments with both my new psychiatrist and neuro this month, and just need to step away from my old psych (who I noticed in the newspaper today didn't pay his taxes and got slapped by the Feds), and do my paperwork to transfer stuff. Best of luck to my old neuro as she moves to New Jersey.  I found that out through a meeting of the minds of the two people who showed up at the support group Thursday.  I could not have met a more gracious lady, and I hope the group works out.

from The Girl With MS

Why can't we sleep? There is no real reason other than MS as to why I have sleep issues, but it's amazing how I can mess myself up!

Here I am in the beautiful Eastern Sierras listening to Bishop Creek as it riffles by below the cabin. My current view:

On vacation but with a few minor projects and tasks to tend. But not enough to keep me awake all morning. The first night I was exhausted and fell asleep at 9pm when my head hit the pillow, awaking at 4am, which did constitute seven hours of sleep. But I didn't want to be awake at 4am.

So last night I aimed to stay up later thinking I could get seven hours and wake at a reasonable time. Now as the day progressed, after some time in the warm Bishop sun, some fly fishing and some creative cooking, I thought to myself, you are at 8,500' altitude, "Go fill up your water glass". Yes, I thought this often, every time I opened another beer.

I even thought of the magnesium supplement, magneleveux, in my bag, as I opened another beer.

Daydreaming, sketching, visualizing, I had a fun night, as I opened another beer.

Exactly what NOT to do with MS!

Sure, I stayed up until midnight, then woke up at 4:38am. Bing! And I'm awake. The need to pee and the incessant leg spasticity kept me squirming all morning long. The 42 degrees winding through the window bringing with it the sound of the creek was my saving grace. Ugh. I know better. I did take 1/2 a klonopin and a melatonin before going to bed. And another half of klonopin in am when couldn't fall back to sleep.

Three glasses of water later, a banana, magnalevure and some Shen Trition, and this Girl with MS is finally feeling a little better.

What I could have done:
  • Enjoyed the great healthy dinner we had (micro greens, salmon, veggies)
  • Dry brushed my legs
  • Took a not to hot bath
  • Read a book
  • Wrote in blog

Yes, these are all better choices then the one I made. So, live and learn. Let go and let God as they say.

This all inspired me to do some researching on sleep and MS. Here is some of what I found:

This is a great summary from WebMD of what can cause folks with MS to have restless sleep: Multiple Sclerosis and Sleep

Life aspects that can effect sleep patterns in those with MS:
  • Stress
  • Anxiety
  • Eating
  • Drinking
  • Nutritional health
  • Age
  • Physical activity
  • Mental activity
  • Spasticity
  • Depression
So, how do we deal with this sleep issue?

Time to change our habits!

Food suggestions:

Small bananas are good: (they still contain sugar so small is better before sleep)

"Combining the amino acid tryptophane with carbohydrates as well as calcium and  magnesium can help your brain relax and your body nod off to sleep."

And the magic of oatmeal can make the difference of a more restful sleep pattern:

"Calcium has been proven to help the brain use and process tryptophan, while  magensium, a natural sedative, acts as an "assistant" to calcium helping it to be absorbed into your system."

Check out more Foods to eat before bedtime from The Health Central Network

There are other things too. This is just a start!

There is Proof that sleep patterns affect MS!

If you've been having sleep issues and feeling more fatigued, there is proof that the two go hand in hand.

Check out this study: "Treatment of sleep disorders can improve fatigue and other clinical outcomes in MS."

“@MSBuzzNews: Multiple Sclerosis Research: Treatment of sleep problems reduces fatigue: Epub: Côté et al. Impact of sleep diso...”

Ok kids. There is more to come on this and would like your thoughts but there's a high Sierra creek calling my name....

from Lisa Emrich of Brass and Ivory: Life With MS and RA

Sleep disorders, especially sleep apnea, can cause fatigue and increase the risk of cardiovascular disease.  Untreated sleep apnea can lead to depression, heart disease, diabetes, obesity, and excessive daytime sleepiness.  Stress hormones released during frequent drops in blood oxygen level caused by sleep apnea increase the risk of high blood pressure, heart attack, stroke, irregular heart beats (arrhythmias) and heart failure.  Excessive sleepiness can lead to fatal car crashes and accidents at work.

Sleep disorders may be under-diagnosed in both rheumatoid arthritis and multiple sclerosis, according to research.  For information regarding sleep disorders, including sleep apnea, and their connection with RA and MS, please read the following posts I wrote this week for HealthCentral.


This concludes the 122nd edition of the Carnival(Apologies for the late posting.)  The next Carnival of MS Bloggers will be hosted here on September 13, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, September 11, 2012.

Thank you.

Tuesday, September 4, 2012

Two-year Update on MS Society-Funded CCSVI Projects

The National MS Society has released a two-year progress report on the seven society-funded CCSVI research studies in MS.  While some researchers have presented preliminary findings at the ECTRIMS conference in October 2011 and the AAN conference in April 2012, most researchers are still in the process of completing their projects.

Updates for each of the seven projects (as of January 2012) are available on the NMSS website.  Click on the title of the research project to open up a more detailed description of the project and preliminary results, including links to abstracts presented at ECTRIMS by Drs. Fox and Wolinsky.  Details of the posters presented at AAN by Drs. Fox and Wolinsky are included in the Society’s news bulletin of May 16, 2012.

One team of society-funded researchers from Calgary has published a paper based on the cases of five people who had experienced medical complications after undergoing CCSVI venoplasty procedures: “Complications in MS Patients after CCSVI Procedures Abroad.” Burton JM, Alikhani K, Goyal M, Costello F, White C, Patry D, Bell R, Hill M. (Calgary, AB) Can J Neurol Sci 2011 Sep;38(5):741-6. 

For information regarding other CCSVI-related studies, the CCSVI Alliance maintains a searchable database of published articles.

National MS Society Press Release (May 4, 2012):

Researchers Continue With Their Progress in the Seven Society-Funded CCSVI Studies in MS

Seven research projects investigating CCSVI (Chronic Cerebrospinal Venous Insufficiency) and MS -- launched with a $2.4 million investment by the National MS Society and the MS Society of Canada -- have reached the two-year milepost.

The funded multi-disciplined researchers have been reporting significant progress in their two-year study goals. As of July 2012, most of the investigators are in the process of completing their projects and expect to do so within the next year. Although the work continues for several of the teams, some are already presenting preliminary results at medical meetings, and all have shared technical advice so that the projects can move forward as smoothly and quickly as possible.

The need for continued work beyond the two-year grant funding period is not uncommon, as practical and logistical issues begin impacting on projected timelines, including such items as:
  • getting proper protocols in place;
  • applying for and gaining approvals from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a requirement established by regulatory authorities to protect humans involved in research projects;
  • getting technicians and other team members trained on how to conduct appropriate screenings; and
  • recruiting study participants.
After the research projects are completed, the data collected in these studies will be analyzed and submitted for publication in one or more scientific journals so that other scientists can evaluate and comment on the findings. Currently it is not known when the full data and results will be available, though updates will continue as appropriate to reflect the ongoing transparency of the work being supported by the U.S and Canadian MS Societies. Results from the seven projects, as well as other studies underway around the globe, will help guide our planning for future investments in this area of research.

Research project highlights and progress
  • The teams include an integration of experts drawn from all key relevant disciplines including neuroradiology, neurovascular imaging, MS imaging, vascular surgery, biostatistics, interventional radiology, interventional neuroradiology and MS clinical neurology. Bringing together experts across these areas will help to facilitate understanding of CCSVI in MS as quickly as possible.
  • The research teams have recruited and scanned a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process. 
  • Already more than 900 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.
Some of the teams have been trained in, and are using, the ultrasound technique originally published by Dr. Zamboni. Others are using the same methods but are utilizing standard Doppler ultrasound machines rather than purchasing the specific machine used by Dr. Zamboni’s team. 

Future Steps – Clinical Trial and Live Webcast PlannedGrantee results will help guide future steps, including the development of a clinical trial to test whether treating vein blockages is a safe and effective therapy for people with MS. The Canadian Institutes of Health Research (CIHR) announced in April 2012 that a research team had been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The location of the study has not yet been announced.  The clinical trial is a collaborative initiative between the CIHR and the MS Society of Canada.

At this point, no connection has been confirmed between CCSVI and MS, in fact, CCSVI appears to occur in many people who do not have MS. Although some individuals who have MS have undergone surgical procedures for CCSVI, there has not yet been a controlled trial to determine its effectiveness in treating the symptoms or course of the disease. In addition, the U.S. FDA has issued a safety communication about potential risks associated with procedures and devices used to treat CCSVI, encouraging additional research.

The National MS Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible, and is urging researchers to complete their studies and to analyze and publish their results as soon as possible. The Society plans to host a live Webcast in the spring of 2013 as a forum for a discussion about the progress made in the understanding of CCSVI and MS. 

For those who may not want to wait for research results in order to get tested for CCSVI and/or who want to undergo surgical treatment now, this is a personal decision to be discussed with their healthcare providers. To get the most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, as well as to further the overall understanding of CCSVI and how it may affect people diagnosed with MS, it is important that such surgery be performed as part of controlled trials, especially in light of adverse events reported to date.