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Thursday, May 3, 2012

Oral MS Drug Gilenya May Carry Serious Side Effects








By CRegalEditor
 - May 1, 2012


As many likely already are aware, Gilenya was approved by the FDA for use in the United States back in September 2010.  It is the first--and only--oral disease-modifying drug for multiple sclerosis.  Once thought to be something that would only exist in a futuristic world with flying cars and jet packs, an oral MS drug is a reality. 

Unfortunately, it may also carry serious side effects.

Although Gilenya was approved by the FDA, the drug carries a warning that it could slow a patient's heart beat when they start taking the medication.  The FDA guide indicates that, "your heart rate will usually slow down the most about six hours after you take the first dose," but also notes that your slow heart rate should return to normal within one month of starting Gilenya.  The FDA also warns to contact a doctor if you experience dizziness, tiredness or a slow or irregular heartbeat. 

Before taking the drug, then, it would be wise to inform a doctor of any previous heart problems you may have experienced.

And now the European Medicines Agency (EMA) – the European equivalent of the FDA – is recommending that doctors not prescribe the drug to patients with a history of cardiovascular and cerebrovascular disease or those taking heart-rate lowering medication.  The EMA also recommends that anyone considering taking Gilenya first have a doctor monitor their heart activity prior to starting the drug.  Their heart rate should also be closely watched immediately after taking the drug for the first time - the aforementioned six-hour window. 

The Committee for Medicinal Products for Human Use – the division of the EMA that issued the new recommendations – closely examined 15 incidents of sudden or unexplained deaths in patients who took Gilenya.  The majority of these deaths were cardiovascular in nature but were not necessarily directly tied to the drug. 

The bottom line is that Gilenya can be very beneficial to patients with multiple sclerosis, but its use needs to be closely monitored by a doctor.  Patients should have a heart monitor test before taking the drug and patients with a history of heart problems should avoid the Gilenya.  

Source:
 Rattue, Petra.  (27 April 2012).  Gilenya Heart Side Effects – European Medicine Agency Gives New Recommendations.  Medical News Today.  Retrieved fromhttp://www.medicalnewstoday.com/articles/244719.php


Article Source: http://www.healthcentral.com/multiple-sclerosis/c/215658/152565/carry?ic=6081

Article provided by Aileen W. in Boca Raton Fl.



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New MS awareness Video - an MS Patient's Video


"Frustrations of MS Changes"






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HIKING for M.S.



My name is Shawn Feliciano Garber.

I was diagnosed with Relapsing Remitting Multiple Sclerosis in August of 2009. It was less than a month before my wedding.  Although I didn’t know a lot about the disease the diagnosis left me stunned. I wasn’t sure how that would affect my outdoor spirit. I had always considered myself a healthy and adventurous individual.  Would I be wheelchair bound or have limited physical access?

After many trials and tribulations, I was finally able to accept my diagnosis and overcome the side effects, of not only the medications, but of the disease itself. I realized that I was still strong and had the fight within me to deal with the multiple sclerosis and help others do so as well. There would be many like myself who would face the same challenges. 

I am fortunate in that I have been fortunate to do and see a lot in my life and those experiences have helped me reach out to others who might not be so fortunate.

The hiking of the Arizona Trail, 817 miles across the state of Arizona, came about on one of our hikes through the Grand Canyon. My husband Bob and I wanted to hike an area that would be accessible to others regardless of physical limitations. The Trail can be segmented and its trails are available to all.

Why would I hike 817 miles?  Raise awareness within the general public. Multiple Sclerosis is often ignored or misunderstood amongst the general public. It often brings stigmas and prejudices because of a general lack of understanding.   My main goal is to foster and encourage other MS patients to find courage and resiliency in their individual battles against Multiple Sclerosis.  To fight and embark on their individual “Big Hike”, whatever that might be.

During my hike, which will take 2-3 months and begins on August 4th, 2012, we will also be raising funds for National MS Society; MSViews and News and future hikes for Hiking for Multiple Sclerosis.

I am not a famous person but just someone who would like to make a difference in the lives of others by helping others in their own struggles.  Ultimately, we each make an impact not only in other’s lives but by bringing out the inherent happiness, courage and strength within each other.


Donations can be sent to:
Send Checks to:
Hiking for Multiple Sclerosis
P.O. Box 236 Springville, Ut. 84663

OR go to: www.az817.org there is also an option for paypal.


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Wednesday, May 2, 2012

How Does the Immune System Fight Off Threats to the Brain?


ScienceDaily (Apr. 30, 2012) — Like a police officer calling for backup while also keeping a strong hold on a suspected criminal, immune cells in the brain take a two-tier approach to fighting off a threat, new research from the University of Michigan Health System finds.


This illustration shows what the researchers found -- that a killer T cell (yellow) in the brain can target an infected or tumor cell (marked with A) and surrounding cells by releasing cytokines (dots) both within the gasket-like immunological synapse between the cells, and into the surrounding area via "leaks." These findings may help advance research on infections, tumors and autoimmune disease. (Credit: Lowenstein/Castro lab)
For the first time, the scientists managed to capture that reaction in action, showing how certain immune cells locked onto a model of virus-infected brain cells, while also sending signals to neighboring uninfected cells to let them know about the immune attack.
The findings may help research on how the brain fights off viruses and tumors. It also aids the search for ways to harness the immune response to attack and kill brain tumor cells -- or to calm the overzealous self-attack that occurs in people with certain autoimmune diseases.
Published online April 30 in theProceedings of the National Academy of Sciences, the findings illuminate how cells called CD8+ T cells, or "killer" T cells, carry out their police-like role. Pedro Lowenstein, M.D., Ph.D., professor in the Department of Neurosurgery at the U-M Medical School, led the research team.
He explains that the research yields new insight into the nature of the "gasket" that forms between killer T cells and their target cells, i.e., infected -- or tumor -- cells. Killer T cells go after cells when they detect the presence of foreign proteins, called antigens, on the cell surface.
The gasket-like structure creates an area between the two cells called an immunological synapse -- and has been thought of by some scientists as a tight seal. Studies, including previous ones by Lowenstein's team, have suggested that it allows the killer T cell to lock on to its target and bombard it first with molecules called cytokines, and then with chemicals that break down the infected cell and kill it.
But other scientists have shown that when killer T cells are attacking infected cells, the cytokines they release seem to cause a reaction in many neighboring, uninfected cells -- suggesting a very open connection. These latter studies question the role of immunological synapses.
Using a unique live-cell imaging technique developed by the team, the new results show that the gasket connection focuses the T cell attack on the infected cell, but is leaky. This creates a two-tier response when a killer T cell goes after an infection.
"The T cell targets the infected cell preferentially, but it also secretes cytokines that reach a number of other cells in the neighborhood," says Lowenstein. "The immunological synapse fails to restrict how far cytokines can spread."


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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.

Source: MS Foundation's Movers and Shakers newsletter


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Investigators Recruiting for Study of Daclizumab HYP Delivered in Prefilled Syringe–


Re-posted News from the MS Foundation


Investigators worldwide are recruiting 100 people with relapsing-remitting MS for a study testing the use of a prefilled syringe to administer monthly under the skin injections of the experimental therapy daclizumab high yield process (DAC HYP). Specifically, the study is looking at the immune response that is stimulated by this delivery method, and how the drug is absorbed in the body. This study – also called the OBSERVE study – is being sponsored by Biogen Idec and Abbott Biotherapeutics.

To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email neurologyclinicaltrials@biogenidec.com.



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Participate in a Trial of Vitamin D Supplementation–


News from the MS Foundation:


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://www.clinicaltrials.gov/ct2/show/NCT01490502, or e-mail vitamindtrialms@jhmi.edu



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How Big Data Is Fighting Multiple Sclerosis


SUNY Buffalo researchers will use IBM Netezza appliance and third-party software to seek cures for multiple sclerosis.




Researchers at the State University of New York (SUNY) at Buffalo are harnessing "big data" technology from IBM and another firm in the fight against multiple sclerosis.
The scientists will use IBM's Netezza analytics appliance, combined with software from Revolution Analytics, to analyze huge databases and seek correlations among genetic, clinical, and environmental factors that might help reveal the causes or the acuity of MS in particular individuals.
The insights that the researchers derive from this approach might help pharmaceutical companies develop new drugs or might help physicians and patients better manage the disease, said Shawn Dolley, VP of big data, healthcare, and life sciences for IBM, in an interview with InformationWeek Healthcare.
The SUNY Buffalo scientists have been using Netezza, a massively parallel computing system, for the past two years and have published some papers based on that research, Dolley said. But the addition of Revolution Analytics' application will greatly increase the number of variables they're able to include in their analyses, he said.
[ Is it time to re-engineer your clinical decision support system? See 10 Innovative Clinical Decision Support Programs. ]
The big difference between what the researchers were doing earlier and what they're able to do now is that, instead of using computers to test a particular hypothesis, they will use the Big Data approach to spread as wide a net as possible.
"The SUNY Buffalo people have said with the decreased cost of the IBM Netezza and its amazing processing power, they're going to let the computer discover what the relevant phenotypes are and look at every combination of every possible variable across a large number of patients," Dolley said. Phenotype refers to the physical characteristics of a patient that result from the interaction of his genetic makeup with the environment. According to an IBM press release, the researchers will be able to study more than 2,000 genetic and environmental factors that might contribute to MS. The reason for this scattershot approach is that scientists still understand relatively little about this condition, which affects 400,000 people in the U.S. MS is now regarded as a type of auto-immune disease, but environmental, genetic, and infectious factors might play roles in MS.
The UB researchers will incorporate patient data including medical records, lab results, MRI scans, and patient surveys, as well as genomic datasets obtained from the National Institutes of Health and other sources. Among the specific factors to be examined are patients' gender, geography, ethnicity, diet, exercise, sun exposure, and living and working conditions.




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