Comments & a CCSVI Update

I want to take a moment to thank everyone who has left a comment on this blog!  It is so amazing to know that people are reading and that my blog has an impact.  I think I had forgotten that, to some extent, until my last post (Too Long).  In response to that post, I got two very kind, very supportive, very positive comments.  It reminded me of why I started this blog and it reminded me that everyday is a blessing and that I need to stay optimistic.  Your comments lift my spirit and I appreciate your words!  I am so lucky to have such an amazing support system, from my family to my friends to the readers of my blog.  It warms my heart to know that people whom I have never met support me.  It is also always great to hear about other people's experiences with MS; it helps me remember that I am not alone in this fight and that there are so many people to be fighting for.  I hope and pray that someday soon we will have a cure.  Thanks again for your continued support and for your always appreciated comments!

And now . . . a CCSVI update from the MSAA:

Background Information on CCSVI and MS

Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage. With CCSVI, the veins located on the outside of the brain (extracranial cerebrospinal veins) - those designed to transport blood from the brain back to the heart - collapse and/or become blocked, a condition known as "stenosis." Studies have shown that when the normal blood flow is altered, especially when the flow of blood is reversed, the body may react with an inflammatory response.
Two years ago, Paolo Zamboni and others published the results of a pilot study in the December 2009 edition of the Journal of Vascular Surgery. In this article, lead investigator Dr. Zamboni describes an experimental procedure to widen the narrowed or blocked veins in a study of 65 MS patients. Some refer to this as the "liberation procedure," where angioplasty is performed using a tiny balloon inserted into an affected vein. From this small, open-label study, Dr. Zamboni noted that a portion of the patients with relapsing-remitting MS (RRMS) experienced fewer relapses and improvement in function.
Since these results were published, the CCSVI theory in MS has received a great deal of attention. While a small number of studies are underway, some MS patients are seeing vascular surgeons or interventional radiologists on their own to undergo speculative diagnostic and corrective procedures. Additionally, vascular specialists and neurologists are not always in complete agreement about the presence of this condition in patients with MS and the procedures.
Anecdotally, some individuals with MS who have undergone a procedure feel that they are experiencing some improvement in certain symptoms. Typically, these might include improvements in fatigue, heat sensitivity, sleep, concentration, and balance. Over time, some even attribute improvements in bladder issues, mobility, flexibility, and other symptoms to the procedure. Conversely, some patients did not see any improvement following the procedure.

Research Challenges with CCSVI and MS

The problem faced by the medical community in researching the CCSVI theory is two-fold. First, researchers need to prove whether or not CCSVI occurs more often in individuals with MS versus the general population, and if so, how it may be related to the disease. Further complicating the issue is the fact that no single procedure or protocol has been identified for its diagnosis, and a wide range of results can occur when using different imaging equipment, techniques, and technicians.
The second problem in researching the CCSVI theory involves treating the condition. Dr. Zamboni and others have used an angioplasty-type of treatment for opening closed veins with a tiny balloon that is inflated several times and then removed. Possible adverse events can include bleeding, heart arrhythmias, and rarely an allergic reaction to the dye used to illuminate the veins. Additionally, veins sometimes close (restenosis) in the months following the procedure. A second option is to insert a stent into the closed veins, which poses additional risks - such as the stent dislodging and moving to another area of the body - requiring immediate surgery. Even with the stents, scar tissue can sometimes form and clog the stent. Finally, doctors will still need to determine if and to what extent MS patients may benefit from such a procedure, and if the benefits outweigh the risks.
More than 50 articles on the subject have appeared in peer-reviewed publications over the past two years, although many present conflicting results - with some finding significant proof of CCSVI in MS patients, and others finding no evidence - a problem often blamed on the lack of a protocol for specific diagnosis. Doctors are also looking at possible relationships between CCSVI and known risk factors for MS, including Epstein-Barr virus, genetic factors, Vitamin D deficiency, and cigarette smoking.
Experts agree that a strict protocol for testing will need to be developed, that a combination of tests may be required for a confirmed diagnosis of CCSVI, and that the operators performing these tests will need specialized training for consistent results. Another impressive hurdle in these studies is the issue of blinding. The researchers, doctors, and operators performing the diagnostic tests and evaluating the patients after the procedures need to be blinded as to who has MS and who received the active treatment, or the results could be biased.

Current Studies and CCSVI Registry

Studies may be found by visiting www.clinicaltrials.gov and searching for "CCSVI and multiple sclerosis." Many of the studies are listed as still recruiting participants, but interested individuals should check with the contact person listed for the most current information on recruitment. Currently, seven studies are listed, with locations in New York, Texas, California, Poland, and Italy. In June 2011, the Canadian Institutes of Health Research announced that they will be proceeding with a Phase I/II clinical trial.
One of the studies listed is sponsored by the Hubbard Foundation, titled, "Multi-center Registry for CCSVI Testing and Treatment." Located in San Diego, California, the purpose is to develop a registry of patients evaluated and treated for CCSVI, looking at changes in quality of life. The Hubbard Foundation is looking for doctors and medical facilities that perform CCSVI testing and treatment to register under their IRB (Institutional Review Board) approval to conduct research and provide the outcome of those tested and treated for CCSVI.
In June 2010, the National MS Society and the MS Society of Canada committed more than $2.4 million to support seven new research projects focusing on the role of CCSVI in MS.

Closing Remarks

As with any unproven theory and treatment, interested patients are strongly encouraged to talk with their doctor, and if appropriate, participate in an approved clinical trial. Without a tested and proven protocol for the diagnosis and treatment of CCSVI, individuals could be putting themselves at risk. In July 2011, news arrived of a second individual with MS from Canada who sought treatment outside of the country and died due to complications. Although such tragic results are not common, individuals considering these types of procedures should be aware of the risks involved.
MSAA enthusiastically but cautiously supports the investigation of potential causes and treatments for MS, striving to communicate such research to the MS community as soon as any information becomes available. However, MSAA's policy is to consider patient safety as the top priority - recognizing that all prospective theories and experimental treatments need to be thoroughly studied through rigorous clinical trials.

For more information on CCSVI from the MSAA, visit the MSAA's news center.

Thanks for reading!

Too Long

It has been too long since I last posted and, for that, I am sorry.  I have been a little down lately and I haven't had the motivation to post.  I guess I am finally realizing what it means to have relapsing-remitting MS.  I have been experiencing some numbness, tingling, and L'Hermittes intermittently lately and it has been frustrating.  I had been doing very well with little to no symptoms at all, but lately I have noticed some flare ups.  I am still much better off than I could be and I am grateful for that, but I was really enjoying being in complete remission.  Relapses suck, even the less severe relapses.  My "flare ups" have not been particularly bad (nothing like my symptoms before beginning treatment), but they are noticeable, which is enough to put me in a bit of a funk. 
I did go for a run for the first time since my diagnosis.  I am trying to get back into a workout routine so I went for a jog and my entire lower half was numb by the end, plus I was experiencing L'Hermittes pretty bad.  Will continue to jog for awhile and hope that my symptoms don't get any worse.  I just need to stay as cool as possible (with winter on the way, that shouldn't be too difficult). 

In other news, a dog park just opened up about 2.5 miles from our house, so we took our puppy there today.  He was in doggy heaven; he loves playing with other dogs.  He listened well and played nice, so it was definitely a success!  We will have to take him back soon.

Enough about me.  A recent study found that "subjects who were born by Caesarean section had a significantly higher risk of developing MS. The authors conclude that their results suggest those born by vaginal delivery are at a lower risk of subsequent MS, but that much larger and preferably prospective studies are needed."  This is very interesting to me; I am not sure how this would affect risk of developing MS, but apparently it may be a contributing factor.

For a limited time only, every donation made to the NMSS is doubled. Go to the NMSS website today to make a donation!!!

Follow up - MSF News

Now, more from the MSF email:

FDA Approves Botox to Treat Urinary Incontinence with MS

The U.S. Food and Drug Administration has approved Botox® (onabotulinum toxin A) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder. The approved treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

"Urinary incontinence associated with neurologic conditions can be difficult to manage,” said George Benson, deputy director, Division of Reproductive and Urologic Products. “Botox offers another treatment option for these patients."

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in people with bladder overactivity associated with a neurologic condition is up to 10 months.

The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The participants had urinary incontinence resulting from spinal cord injury or MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid, and a condition in which the eyes are not properly aligned.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.

Botox is marketed in the United States by Allergan Inc., of Irvine, Calif. 

Laquinimod Faces Hurdles
Teva Pharmaceutical Industries, Ltd. faces growing challenges and uncertainty surrounding its MS treatments, according to an Oppenheimer analyst.

The Israeli drugmaker said that its experimental drug, laquinimod, an oral MS treatment, did not reduce patients' annual relapse rates in a late-stage clinical trial. The study involved 1,331 patients who were treated with one of three options: laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec, Inc.

Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis, and if study results are adjusted to remove that imbalance, laquinimod met its main goal of lowering the relapse rate.

Teva and its partner Active Biotech still plan to seek approval of laquinimod in the U.S. and the European Union. In December, the companies said the drug met its main goal in its first late-stage trial.

Analyst Christopher Holterhoff said in a research note it is unclear whether the U.S. Food and Drug Administration will accept adjusted data from the latest study as meaningful or require Teva to run another study.

"We are unaware of a precedent case where an MS drug was approved without two statistically significant trials," the analyst wrote.

Free Smartphone App Helps Keep Track of Injections
A free smartphone app, TrackMyShots, is available to help ease the log-keeping of people with MS, diabetes, and other conditions requiring frequent injections.

The app eliminates the need for bulky log books by allowing the user to record each injection, track injection sites, and monitor adverse reactions. Users can set up an ongoing schedule for their injections and get email alerts when it is time for their next shot.

Developed by Linxter, Inc., a software development company in Cooper City, Fla., the app was created to help a family friend with MS, says company CEO and founder Jason Milgram.

“She had carried around a bulky paper logbook for years,” Milgram said. “She and her husband asked if I could help develop an app that would allow her to keep track of the injections.”

The app’s initial release is available for Windows Phone 7 users. An Android version was scheduled to be available in late August, and iPhone users will be able to access the app in late September.

TrackMyShots, http://trackmyshots.com, recently received a Hero of the Week award from Microsoft, which “honors excellence in the field of app development.”

Definitely going to look into that app!  It looks as though Gilenya may continue to be the only available oral treatment for awhile.