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Friday, November 2, 2012

The Lancet criticizes Sanofi for cost of Lemtrada, withdrawal of Campath


PARIS (Reuters) - Medical journal The Lancet warned that Sanofi's experimental multiple sclerosis drug Lemtrada may be too costly for patients and health insurers once it gets approved by regulators.
The journal, which published the encouraging results of two late-stage Lemtrada tests on Thursday, also criticized the drugmaker's decision to withdraw leukemia therapy Campath, the same drug given at a different dosage, depriving MS patients who had been using it off-label.
In an editorial accompanying the test results, The Lancet voiced concerns that Lemtrada would be priced higher than current MS drugs on the market and said the discontinuation of Campath may mean patients who had used it for MS would not be able to continue their treatment.
The injectable drug, chemically known as alemtuzumab, was sold until September 2012 under the name Campath as treatment for leukemia and given more frequently at a higher dosage.


Read more: http://medcitynews.com/2012/10/the-lancet-criticizes-sanofi-for-cost-of-lemtrada-withdrawal-of-campath/#ixzz2B6jj3dCc


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UB Neurological Researcher and Expert on CCSVI Testifies in Canadian Senate Hearing


He calls for more clinical trials before interventions or treatments can be advanced

Release Date: November 1, 2012
BUFFALO, N.Y. -- Robert Zivadinov, MD, PhD, FAAN, University at Buffalo professor of neurology, provided invited testimony today to the Canadian Senate on Bill S-204, "An Act to establish a national strategy for chronic cerebrospinal venous insufficiency (CCSVI)."
CCSVI refers to impaired blood flow from the central nervous system to the periphery. It has been hypothesized that this narrowing of veins restricts blood flow from the brain, altering brain drainage, and may contribute to brain tissue injury that is associated with multiple sclerosis.
CCSVI has generated intense interest among MS patients worldwide. Independent scientific studies, including one of the largest to date being conducted by Zivadinov and UB colleagues, have suggested an association with MS, although none have found conclusively that the condition is associated with MS.
"While our research points against CCSVI having a primary causative role in the development of MS, we have established that there is a higher prevalence of CCSVI in progressive MS patients," said Zivadinov. "This suggests that CCSVI may contribute to, or be a consequence of disease progression, with important implications for treating its symptoms."
Zivadinov and his colleagues at the Buffalo Neuroimaging Analysis Center, part of UB's Department of Neurology in the School of Medicine and Biomedical Sciences, and at other institutions have published or presented more than 25 studies on CCSVI.
One of these found that patients with other neurologic diseases and healthy individuals also present with CCSVI, a finding that Zivadinov noted further underscores the need for additional research.
"CCSVI intervention should be restricted to blinded, randomized and controlled clinical trials that will establish the safety and efficacy of these endovascular procedures," Zivadinov said. "This should be done according to established clinical, MRI (magnetic resonance imaging), and quality of life treatment outcomes employing safe and ethical approaches.
"Until these steps are accomplished, I believe there is no role for endovascular treatment of CCSVI in MS patients or in patients with other neurological disorders outside of approved clinical trials," he concluded


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Wednesday, October 31, 2012

Psychological Symptoms of MS


MS (multiple sclerosis) damages the central nervous system and nerves, disrupting the nerve signals from your brain to other areas of your body. This creates primary physical symptoms like numbness, coordination problems and fatigue. There are additional psychological symptoms that often accompany the disease.

Depression

  • According to the National Multiple Sclerosis Society, severe clinical depression is more common among MS patients than in patients with other disabling conditions.

Sexual Dysfunction

  • Multiple sclerosis may damage the nerve pathways governing sexual arousal and the ability to achieve orgasm, increasing your risk of sexual dysfunction.
  • The stress of living with a chronic illness combined with the neurological effects of the disease often cause irritability, severe depression, mood swings and the pseudobulbar effect (periods of uncontrollable crying or laughing).

Cognitive Dysfunction

  • According to the Multiple Sclerosis Foundation, nearly half of all MS patients are affected by cognitive dysfunction like memory problems, abnormal reasoning, slow processing of information and slowed speech.
READ MORE




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The Causes of MS Exacerbations


The Causes of MS Exacerbations thumbnail
Lower your stress levels to prevent MS exacerbations.
Multiple sclerosis (MS) is a disease in which the immune system attacks the myelin sheath, or the covering around the nerves, so nerve signals fail to function correctly, according to Kansas' Department of Health and Environment. MS affects parts of the nervous system, such as the brain and spinal cord, causing symptoms which may include speech and vision changes; coordination problems; fatigue; tingling and dizziness. At times, MS patients experience exacerbations in which new symptoms may appear or old ones may become more severe. While exacerbations may occur without a clear-cut reason, several factors are thought to trigger flare-ups.

Stress

  • Both emotional and physical stress can bring on exacerbations in people with MS. Because stress affects your immune system, being under a lot of emotional stress can lead to a worsening of your symptoms, according to WebMD. When your immune system is weakened by prolonged stress, your body cannot deal with MS symptoms as effectively.
    Physical stress also depresses your immune system and may worsen your symptoms. Examples of physical stressors include illness, infections and lack of sleep. MS patients should get the flu vaccine to reduce the chance of getting sick and experiencing exacerbations.

Climate

  • Extreme humidity, heat or cold or sudden shifts in temperature may cause exacerbations in MS patients. Heat causes the already-damaged myelin sheath and nerves to send out signals even more inefficiently than usual, according to WebMD. Patients may experience exacerbations in very cold environments as well. Fortunately, exacerbations caused by extreme climate conditions are not permanent.
Read more: The Causes of MS Exacerbations | eHow.com http://www.ehow.com/list_6870534_causes-ms-exacerbations.html#ixzz2Av49gwWT

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Recovering after a Disaster or Emergency


If you are in need of emergency shelter information and other critical resources as a result of Hurricane Sandy, please contact the Red Cross, your local Red Cross chapter, or FEMA.
The Society’s Information Resource Center can also help families affected by MS find the support and services needed in the midst of crisis, or after the initial emergency has passed. Contact an MS Navigator to learn about financial resources for temporary living assistance, medications, and other MS-related needs : 1-800-344-4867.

MS Views and News hopes that for all who were affected by SuperStorm Sandy, that you find the help you need and that your health remain on top of the list.

For those reading this posting, please forward it to someone else who might be in need, electronically or by phone


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More Medicare Coverage May Soon Help Those with MS


October 2012
After the settlement of a landmark class-action lawsuit this week, Medicare will soon begin paying more often for physical, occupational and other therapies for large numbers of people with certain disabilities and chronic conditions such as MS.
While the reach of change following the ruling is still uncertain, advocates hope that Medicare will soon pay for many forms of therapy that it did not always cover before. For people with MS, this may mean more approval for treatments for spasticity and gait training to prevent falls.

Pending approval by a federal judge, the settlement would end a lawsuit that accused Medicare of allowing the contractors that process its claims to use an “improvement standard” over the last few decades. To the Center for Medicare Advocacy and the many other organizations that joined the suit, that standard seemed to call for cutting off physical, occupational and speech therapy, and some inpatient skilled nursing for many people who had reached a plateau in their treatment.

Medicare is supposed to pay for reasonable treatment of an illness or injury as long as a doctor has prescribed it. For the sort of in-home care that this week’s settlement may affect the most, a doctor must have certified that you are, in fact, homebound and have prescribed treatment that only a skilled practitioner can provide. (The “skilled practitioner” rule keeps Medicare from paying for assistance with everyday activities like bathing and dressing.)

The settlement agreement does not describe itself as an expansion of Medicare coverage. But it does state that the Centers for Medicare and Medicaid Services will revise the manuals their contractors use to make clear that coverage “does not turn on the presence or absence of a beneficiary’s potential for improvement from the therapy but rather on the beneficiary’s need for skilled care.”

The settlement also specifies that skilled care can qualify for Medicare coverage even if it merely maintains someone’s current condition or prevents or slows further deterioration. Certain patients who have had claims rejected will be able to resubmit them.

It is anticipated to take a couple of months before the judge approves the settlement, and then a year or more until the Medicare billing contractors get the newly clarified manuals.

Even so, some patient advocates see no reason for people not to demand coverage that maintains their condition or slows deterioration right now, given that Medicare was supposed to be paying for it all along.

source:MSFyi Newsletter


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Tuesday, October 30, 2012

Top MS Scientists Collaborate at MRF's Annual Research Meeting




Last month, the Myelin Repair Foundation gathered the entire MRF research team together for our annual research meeting, to strategize our pathway moving forward into myelin repair clinical trials. 

Our team of approximately 60 scientists consists of clinical neurologists, cell biologists, immunologists, genetics specialists, government experts and MRF scientific staff members gathered by the bay to collaborate and discuss the latest advances in myelin research towards developing a myelin repair therapeutic. The MRF Principal Investigators presented their latest scientific results alongside with their post-doctoral/graduate students, on posters and in Power Point presentations. Dr. Henry McFarland, head of the MRF Clinical Advisory Board, talked about the history of MS, which began in the early 1300s, with the first known case of MS-an ice skating nun named Saint Liduina of Schiedam. At another session, MRF CAB member Dr. Al Sandrock, Chief Medical Officer and Senior Vice President of Development Sciences at Biogen Idec presented the industry perspective of MS drug development, along with its unique challenges and opportunities to meet patient need.

By gathering our world-class myelin experts together, from places as far as Europe and Australia, the Myelin Repair Foundation facilitated important discussions to strategize our path forward to bring a myelin repair therapeutic to multiple sclerosis patients in 2019.



Best,
   
Scott Johnson
President, CEO and Founder
Myelin Repair Foundation 

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Monday, October 29, 2012

CCSVI and Multiple Sclerosis


By 
WebMD Feature
Reviewed by Louise Chang, MD

People with a lifelong condition like multiple sclerosis (MS) are always on the lookout for a new treatment that might improve, or even cure, their disease. In the last few years, there's been a lot of buzz about a vein condition called CCSVI and its possible connection to MS.
However, this connection is very controversial. Some researchers say treating CCSVI can relieve MS symptoms. Others say CCSVI isn't even real. They compare it to the snake venom, bee stings, and other dubious "cures" that have been proposed to treat MS over the years.
So what is CCSVI? Could it be the next big breakthrough in MS research? Or is it just a false theory with a potentially dangerous treatment?


CCSVI Explained

CCSVI stands for chronic cerebrospinal venous insufficiency. It's a narrowing of veins in the neck and chest that carry blood away from the brain and spinal cord. The theory is that when blood flow is slowed, it backs up into the brain and spinal cord and leads to oxygen loss and iron deposits in the brain.
In 2009, Italian researcher Paolo Zamboni, MD, first introduced the idea that CCSVI might cause MS, or make its symptoms worse. When he used ultrasound to compare the blood vessels of people with and without MS, he found abnormal blood flow in 100% of the people with MS, but in 0% of people without MS.

Does CCSVI Really Exist?

Zamboni's findings sound impressive. But when other researchers have tried to copy his research, they haven't gotten the same results.
  • Some studies have found that CCSVI is more common in people with MS than in healthy people -- but not nearly as common as Zamboni found.
  • Other studies have reported CCSVI in almost exactly the same number of healthy people as in people with MS.
  • Some researchers have also found CCSVI in people with other nervous system conditions.
These differences in results raise questions about whether CCSVI is a real condition and how it relates to MS. "When something is true, it is replicated. This is how science works," says David A. Hafler, MD, chairman of the Yale School of Medicine department of neurology.
Why have researchers gotten such different results? One reason is that research teams use different criteria to evaluate CCSVI.
"The way the ultrasound is conducted is not yet standardized," says Robert Fox, MD, staff neurologist and medical director at the Cleveland Clinic Mellen Center for MS. "It's not like getting a blood count." He found that when people were examined with different types of scans, the number of CCSVI cases changed.
The difference in results could also have to do with something as basic as how much water study participants had to drink before their scans. "If you don't have a lot of volume in the veins they're going to collapse down," Fox says. When he had study participants drink Gatorade before their ultrasound, many of them no longer had signs of CCSVI. "Once you fill up the veins, you have much more blood flowing through them, and they're much more plump."
Even though researchers are still divided on whether CCSVI exists, some studies have started looking at the effects of treating it with surgery.


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Scientists Deepen Genetic Understanding of Multiple Sclerosis

TEHRAN (FNA)- Scientists discovered that 30 percent of our likelihood of developing multiple sclerosis (MS) can be explained by 475,806 genetic variants in our genome.







October 26, 2012
Genome-wide Association Studies (GWAS) commonly screen these variants, looking for genetic links to diseases. 

Corey Watson, a recent Simon Fraser University doctoral graduate in biology, his thesis supervisor SFU biologist Felix Breden and three scientists in the United Kingdom have just had their findings published online in Scientific Reports. It's a sub-publication of the journal Nature. 

An inflammatory disease of the central nervous system, MS is the most common neurological disorder among young adults. Canada has one of the highest MS rates in the world. 

Watson and his colleagues recently helped quantify MS genetic susceptibility by taking a closer look at GWAS-identified variants in the major histocompatibility complex (MHC) region in 1,854 MS patients. The region has long been associated with MS susceptibility. 

The MS patients' variants were compared to those of 5,164 controls, people without MS.

They noted that eight percent of our 30-per-cent genetic susceptibility to MS is linked to small DNA variations on chromosome 6, which have also long been associated with MS susceptibility. 

The MHC encodes proteins that facilitate communication between certain cells in the immune system. Outside of the MHC, a good majority of genetic susceptibility can't be nailed down because current studies don't allow for all variants in our genome to be captured. 

"Much of the liability is unaccounted for because current research methods don't enable us to fully interrogate our genome in the context of risk for MS or other diseases," said Watson. 

The researchers believe that one place to look for additional genetic causes of MS may be in genes that have variants that are rare in the population. "The importance of rare gene variants in MS has been illustrated in two recent studies," noted Watson, now a postdoctoral researcher at the Mount Sinai School of Medicine in New York. 

"But these variants, too, are generally poorly represented by genetic markers captured in GWAS, like the one our study was based on." 


Source: Fars News Agency

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What Medicare Will Cover Even if You’re Not Likely to Get Better



Should the federal government cover the costs of many kinds of treatments for patients who aren’t going to get any better?


It didn’t, for many years. But after the settlement of a landmark class-action lawsuit this week,Medicare will soon begin paying more often for physical, occupational and other therapies for large numbers of people with certain disabilities and chronic conditions like Alzheimer’s disease, multiple sclerosis and Parkinson’s disease.
The two questions patient advocates were left with this week were just how many people may benefit from the clarification of the regulations and how quickly.

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