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Opexa Therapeutics, a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company is rebranding its leading MS therapy with the new name Tcelna(TM). The product, previously known as Tovaxin(R), will now be known as Tcelna as the company positions itself towards the treatment of patients with Secondary Progressive MS (SPMS).

"Opexa has worked diligently in the optimization of its overall manufacturing process and clinical development program while concentrating its efforts in the SPMS indication. The rebranding of our lead product as Tcelna encompasses these advancements and our continued dedication to make a difference in the treatment of MS," commented Neil K. Warma, President and Chief Executive Officer of Opexa.

The name Tcelna (pronounced Te-SELL-nuh) reflects the T-cell derivation of the product. Opexa has requested a registered trademark for the new brand name.

Source: Market Watch Copyright © 2012 MarketWatch, Inc (21/05/12)

A substance in human mesenchymal stem cells that promotes growth appears to spur restoration of nerves and their function in rodent models of multiple sclerosis (MS), researchers at Case Western Reserve University School of Medicine have found.

Their study appeared in the online version of Nature Neuroscience on Sunday, May 20.

In animals injected with hepatocyte growth factor, inflammation declined and neural cells grew. Perhaps most important, the myelin sheath, which protects nerves and their ability to gather and send information, regrew, covering lesions caused by the disease.

"The importance of this work is we think we've identified the driver of the recovery," said Robert H. Miller, professor of neurosciences at the School of Medicine and vice president for research at Case Western Reserve University.

Miller, neurosciences instructor Lianhua Bai and biology professor Arnold I. Caplan, designed the study. They worked with Project Manager Anne DeChant, and research assistants Jordan Hecker, Janet Kranso and Anita Zaremba, from the School of Medicine; and Donald P. Lennon, a research assistant from the university's Skeletal Research Center.

In MS, the immune system attacks myelin, risking injury to exposed nerves' intricate wiring. When damaged, nerve signals can be interrupted, causing loss of balance and coordination, cognitive ability and other functions. Over time, intermittent losses may become permanent.

Miller and Caplan reported in 2009 that when they injected human mesenchymal stem cells into rodent models of MS, the animals recovered from the damage wrought by the disease. Based on their work, a clinical trial is underway in which MS patients are injected with their own stem cells.

In this study, the researchers first wanted to test whether the presence of stem cells or something cells produce promotes recovery. They injected mice with the medium in which mesenchymal stem cells, culled from bone marrow, grew.

All 11 animals, which have a version of MS, showed a rapid reduction in functional deficits.

Analysis showed that the disease remained on course unless the molecules injected were of a certain size; that is, the molecular weight ranged between 50 and 100 kiloDaltons.

Research by others and results of their own work indicated hepatocyte growth factor, which is secreted by mesenchymal stem cells, was a likely instigator.

The scientists injected animals with 50 or 100 nanograms of the growth factor every other day for five days. The level of signaling molecules that promote inflammation decreased while the level of signaling molecules that counter inflammation increased. Neural cells grew and nerves laid bare by MS were rewrapped with myelin. The 100-nanogram injections appeared to provide slightly better recovery.

To test the system further, researchers tied up cell-surface receptors, in this case cMet receptors that are known to work with the growth factor.

When they jammed the receptors with a function-blocking cMet antibody, neither the mesenchymal stem cell medium nor the hepatocyte growth factor injections had any effect on the disease. In another test, injections of an anti-hepatocyte growth factor also blocked recovery.

The researchers will continue their studies, to determine if they can screen mesenchymal stem cells for those that produce the higher amounts of hepatocyte growth factor needed for effective treatment. That could lead to a more precise cell therapy.

"Could we now take away the mesenchymal stem cells and treat only with hepatocyte growth factor?" Miller asked. "We've shown we can do that in an animal but it's not clear if we can do that in a patient."

They also plan to test whether other factors may be used to stimulate the cMet receptors and induce recovery.

Source: Medical Xpress © Medical Xpress 2011-2012 (21/05/12)

Efforts at making a medication derived from cannabis available for persons with Multiple Sclerosis have moved a step closer, with the completion of the European Mutual Recognition Procedure.

Galway West Deputy Seán Kyne confirmed the news this week, saying that he had a number of representations made to him by constituents concerned at the lack of availability in Ireland of Sativex, a cannabis-derived medication which has been shown to successfully alleviate some of the debilitating symptoms of MS.

“Sativex is available in Britain and the US and has been very successful in assisting people with MS. I first raised the issue of its availability here with the Minister when several constituents contacted me who either have MS or have relatives or friends with the condition.

“Since last September, Minister Reilly and his Department have been examining how to proceed with introducing such a medication that requires the amendment of the Misuse of Drugs Act 1977 which rightly prohibits the manufacture, production, preparation, sale, supply, distribution and possession of cannabis but unfortunately also prohibits cannabis-based medicinal products.”

Deputy Kyne continued to add that the European Commission had been running a European Mutual Recognition Procedure for the drug, alongside the the Department of Health review.

The European Mutual Recognition Procedure was introduced with the 2001 Directive on the Community Code Relating to Medicinal Products for Human Use and aims to ensure agreement on the use of a medicinal product that has been introduced in at least one member state of the EU.

“With the successful conclusion of the procedure, the manufacturer of Sativex, GW Pharma, has committed to working on the wording, packaging and pricing of the medication for introduction in other member states,” explained Deputy Kyne.

“I’m confident that the European efforts, alongside the review underway at the Irish Department of Health, will soon see the introduction of Sativex on the Irish market to the benefit of people in Ireland with MS.”

Source: Galway Independent Copyright © 2007 - 2012 | Powered by iMedia Revenue Ltd (21/05/12)

The Myelin Repair Foundation (MRF) today announced the results of a new peer-reviewed research study published in Nature Neuroscience that demonstrates functional improvement in immune response modulation and myelin repair with factors derived from mesenchymal stem cell (MSC) treatment in animal models of multiple sclerosis (MS).

Funded by the Myelin Repair Foundation, this research conducted by Case Western Reserve University scientists showed positive results with human mesenchymal stem cells in animal models of MS by not only successfully blocking the autoimmune MS response, but also repairing myelin, demonstrating an innovative potential myelin repair treatment for MS.

Multiple sclerosis is a disease of the immune system that attacks the myelin, causing exposed nerves or "lesions" which block brain signals, causing loss of motor skills, coordination and cognitive ability. Compared to the controls, this research study showed fewer and smaller lesions found on the nerves in the MSC treatment group. MSCs were found to block the formation of scar tissue by suppressing the autoimmune response, which would otherwise cause permanent damage to the nerves. Furthermore, the research showed that MSC treatment also repaired myelin, enhancing myelin regeneration of the damaged axon and the rewrapping of the myelin around the axon in animal models of MS. One treatment of MSCs provided long-term protection of the recurring disease.

Led by Myelin Repair Foundation Principal Investigator and Vice President for Research & Technology Management at Case Western Reserve University's Dr. Robert Miller, this study documents a new promising pathway for treating multiple sclerosis that blocks the autoimmune response and reverses the myelin damage in animal models of MS. The human MSCs used in this study were culled from adult stem cells derived from the bone marrow.

"We are thrilled with the publication of this important research study that examines a new pathway to treat multiple sclerosis, one that reverses the damage of the disease," said Dr. Robert Miller. "Since we were just beginning to understand how MSCs provide myelin repair for lesions, with the Myelin Repair Foundation's support, we continue to deepen our knowledge of exploring the next generation of MS treatments that stimulate healing, rather than symptom suppression of the disease."

"We pride ourselves on supporting best-in-class scientists devoted to find new ways to treat multiple sclerosis, advancing highly innovative research projects that otherwise would not have moved forward," said Scott Johnson, president of the Myelin Repair Foundation. "The success of Case Western Reserve University's study and recognition in this prestigious journal furthers our goal to identify new pathways to treat multiple sclerosis by supporting a multi-disciplinary team of the best researchers in the field."

About the Myelin Repair Foundation

The Myelin Repair Foundation (MRF) is a Silicon Valley-based, non-profit research organization focused on accelerating the discovery and development of myelin repair therapeutics for multiple sclerosis. Its Accelerated Research Collaboration(TM) (ARC(TM)) model is designed to optimize the entire process of medical research, drug development and the delivery of patient treatments.

Source: MarketWatch Copyright © 2012 MarketWatch, Inc (21/05/12)

Multiple sclerosis patients taking natalizumab are at higher risk of developing progressive multifocal leukoencephalopathy (PML) if they are positive for the anti-JC virus antibodies, have been treated with immunosuppressants, and have been treated with natalizumab for longer periods, according to a study published in the May 17 issue of the New England Journal of Medicine.

Gary Bloomgren, M.D., and colleagues from Biogen Idec in Weston, Mass., estimated the risk of PML based on the presence of anti-JC virus antibodies, use of immunosuppressants, and treatment length in 212 confirmed cases of PML from a cohort of 99,571 patients treated with natalizumab (2.1 cases per 1,000 patients).

The researchers found that 54 patients who had samples available before diagnosis were all positive for anti-JC antibodies. The PML risk was lowest in patients negative for anti-JC virus antibodies (0.09 cases or less per 1,000 patients). The risk was highest in patients positive for anti-JC virus antibodies who had taken immunosuppressants before starting treatment and were treated for 25 to 48 months (11.1 cases per 1,000 patients).

"Positive status with respect to anti-JC virus antibodies, prior use of immunosuppressants, and increased duration of natalizumab treatment, alone or in combination, were associated with distinct levels of PML risk in natalizumab-treated patients with multiple sclerosis," Bloomgren and colleagues conclude.

The study was funded by Biogen Idec and Elan Pharmaceuticals. All of the authors disclosed financial ties to Biogen Idec.

Abstract

BACKGROUND
Progressive multifocal leukoencephalopathy (PML) is associated with natalizumab treatment. We quantified the risk of PML in patients with multiple sclerosis, according to the presence or absence of three risk factors: positive status with respect to anti–JC virus antibodies, prior use of immunosuppressants, and increasing duration of natalizumab treatment.

METHODS
We used data from postmarketing sources, clinical studies, and an independent Swedish registry to estimate the incidence of PML among natalizumab-treated patients with multiple sclerosis, according to positive or negative status with respect to anti–JC virus antibodies, prior or no prior use of immunosuppressants, and duration of treatment (1 to 24 months vs. 25 to 48 months). Blood samples were available for anti–JC virus antibody testing from 5896 patients with multiple sclerosis and from 54 patients with multiple sclerosis who were treated with natalizumab and in whom PML later developed.

RESULTS
As of February 29, 2012, there were 212 confirmed cases of PML among 99,571 patients treated with natalizumab (2.1 cases per 1000 patients). All 54 patients with PML for whom samples were available before the diagnosis were positive for anti–JC virus antibodies. When the risk of PML was stratified according to three risk factors, the risk of PML was lowest among the patients who were negative for anti–JC virus antibodies, with the incidence estimated to be 0.09 cases or less per 1000 patients (95% confidence interval [CI], 0 to 0.48). Patients who were positive for anti–JC virus antibodies, had taken immunosuppressants before the initiation of natalizumab therapy, and had received 25 to 48 months of natalizumab treatment had the highest estimated risk (incidence, 11.1 cases per 1000 patients [95% CI, 8.3 to 14.5]).

CONCLUSIONS
Positive status with respect to anti–JC virus antibodies, prior use of immunosuppressants, and increased duration of natalizumab treatment, alone or in combination, were associated with distinct levels of PML risk in natalizumab-treated patients with multiple sclerosis. (Funded by Biogen Idec and Elan Pharmaceuticals.)

Gary Bloomgren, M.D., Sandra Richman, M.D., Christophe Hotermans, M.D., Meena Subramanyam, Ph.D., Susan Goelz, Ph.D., Amy Natarajan, M.S., Sophia Lee, Ph.D., Tatiana Plavina, Ph.D., James V. Scanlon, Pharm.D., Alfred Sandrock, M.D., and Carmen Bozic, M.D.

Source: N Engl J Med 2012; 366:1870-1880May 17, 2012 NEJM.org Copyright © 2012 & Doctors Lounge Copyright © 2001-2012 Doctors Lounge (17/05/12)

Summary: A new epidemiological study from the UK, examining prevalence of MS in northern Scotland, shows a rise in prevalence of the disease over the past 30 years.

The highest increases have been in Orkney, which now has the highest recorded rate worldwide at 402 (95% CI 319 to 500) per 100 000 using the Poser criteria (probable/definite). A rise in prevalence was also seen in Aberdeen and the Shetlands, with lowest levels in the most deprived socio-economic group and highest in women (2.55:1) which the authors believe is best explained by “gene-environment interaction”.

Abstract
Background 30 years ago very high multiple sclerosis (MS) prevalence rates were recorded in northern Scotland. A prevalence study was repeated in Aberdeen, Orkney and Shetland to see if prevalence rates had changed, assess which factors affect prevalence and record disability status.

Methods Hospital, general practice and laboratory records were searched to identify prevalent MS patients (alive and registered with a participating general practice on 24 September 2009). Records were reviewed to confirm diagnoses applying Poser definite and probable and McDonald diagnostic criteria. Disability status (Expanded Disability Status Scale) was recorded from records and questionnaires. Rates were standardised to the Scottish population.

Results 590 patients were found (Aberdeen 442, Orkney 82, Shetland 66). Mean age and disease duration were 53 and 19.4 years, respectively. The standardised prevalence rates for Poser probable/definite MS per 100 000 were: combined area 248 (95% CI 229 to 269), Orkney 402 (95% CI 319 to 500), Shetland 295 (95% CI 229 to 375) and Aberdeen 229 (95% CI 208 to 250). McDonald diagnostic criteria gave a lower prevalence (202, 95% CI 198 to 206). Prevalence was highest in women (2.55:1, 95% CI 2.26 to 2.89) with about 1 in 170 women in Orkney affected. Prevalence was lowest in the most deprived socioeconomic group. 45% had significant disability (Expanded Disability Status Scale ≥6).

Conclusion The prevalence of MS has increased in the overall area, most markedly in Orkney, then Shetland, over the past 30 years. This increase could be due to a number of factors, but rising incidence as reflected by a rising sex ratio, influenced by gene-environment interaction, is the most likely. Orkney has the highest prevalence rate recorded worldwide.

Authors: Visser EM, Wilde K, Wilson JF, Yong KK, Counsell CE.

Source: J Neurol Neurosurg Psychiatry. 2012 May 10 & Pubmed PMID: 22577232 (16/05/12)

Abstract (provisional)

Background

Chronic cerebrospinal venous insufficiency (CCSVI) is a vascular condition characterized by anomalies of the primary veins outside the skull that has been reported to be associated with MS. In the blinded Combined Transcranial (TCD) and Extracranial Venous Doppler Evaluation (CTEVD) study, we found that prevalence of CCSVI was significantly higher in multiple sclerosis (MS) vs. healthy controls (HC) (56.1% vs. 22.7%, p < 0.001). The objective was to evaluate the clinical correlates of venous anomalies indicative of CCSVI in patients with MS

Methods

The original study enrolled 499 subjects; 163 HC, 289 MS, 21 CIS and 26 subjects with other neurological disorders who underwent a clinical examination and a combined Doppler and TCD scan of the head and neck. This analysis was restricted to adult subjects with MS (RRMS: n = 181, SP-MS: n = 80 and PP-MS: n = 12). Disability status was evaluated by using the Kurtzke Expanded Disability Status Scale (EDSS) and MS severity scale (MSSS).

Results

Disability was not associated with the presence ([greater than or equal to]2 venous hemodynamic criteria) or the severity of CCSVI, as measured with venous hemodynamic insufficiency severity score (VHISS). However, the severity of CCSVI was associated with the increased brainstem functional EDSS sub-score (p = 0.002). In logistic regression analysis, progressive MS (SPMS or PP-MS) vs. non-progressive status (including RR-MS) was associated with CCSVI diagnosis (p = 0.004, OR = 2.34, CI = 1.3-4.2).

Conclusions

The presence and severity of CCVSI in multiple sclerosis correlate with disease status but has no or very limited association with clinical disability.

Full Article

Bianca Weinstock-Guttman, Murali Ramanathan, Karen Marr, David Hojnack, Ralph H.B. Benedict, Charity Morgan, Eluen A Yeh, Ellen Carl, Cheryl Kennedy, Justine Reuther, Christina Brooks, Kristin Hunt, Makki Elfadil, Michelle Andrews and Robert Zivadinov

Source: BMC Neurology 2012, 12:26 doi:10.1186/1471-2377-12-26 © 2012 BioMed Central Ltd (16/05/12)

As their European counterparts did last month, the FDA has recommended continued use of the Gilenya multiple sclerosis pill sold by Novartis, but did say the drug should carry stronger warnings about heart risks and that some patients should undergo increased monitoring. The move was largely expected after the European Medicines Agency issued a similar alert, despite arguments by a non-profit safety watchdog that further restrictions are needed.

Although cardiovascular risks were known at the time of approval two years ago, the regulatory review was undertaken in response to patient deaths, including an unexplained sudden death of one person within 24 hours after taking Gilenya for the first time (back story). The back-to-back regulatory decisions will likely ease investor concerns over the prospects for the pill, which Novartis continues to hope will generate blockbuster sales.

The drugmaker has been counting on Gilenya to help compensate for the loss of patent protection on such big-selling drugs as the Diovan blood pressure pill. Meanwhile, competition in the MS market looms as Biogen Idec plans to seek FDA approval for an oral pill shortly.

Last month, Novartis execs maintained that between just 4 percent and 7 percent of MS patients may be at risk for the sort of cardiovascular issues that prompted the FDA and EMA reviews.

The FDA advised doctors not to prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering meds. If Gilenya is considered needed, heart rates should be monitored at least overnight following the first dose. But all patients should have an electrocardiogram and blood pressure measured before a first dose and for six hours after treatment. And continuous ECG monitoring is recommended.

In reaching its decision, the FDA noted data show the maximum heart rate lowering effect usually occurs within six hours of the first dose, but the maximum effect may occur as late as 20 hours after the first dose in some patients (read the FDA statement and data summary here and the EMA report here). Despite these warnings, the FDA did not suggest that all Gilenya patients should be monitored overnight, which Wall Street viewed as a worst-case scenario because such a step would likely have inhibited more widespread usage.

Last month, the Institute for Safe Medicine Practices called on the agency to substantially restrict Gilenya usage and enhance patient monitoring after reviewing adverse events that were reported to the FDA during the second quarter of 2011, shortly after the drug was approved. The watchdog group also criticized the agency for placing Gilenya in its fast-track approval process.

Source: Pharmalot ©2012 UBM Canon Pharmaceutical Media Group (15/05/12)

Smoking marijuana can relieve muscle tightness, spasticity (contractions) and pain often experienced by those with multiple sclerosis, says research out of the University of California, San Diego School of Medicine.

The findings, just published in the Canadian Medical Association Journal, included a controlled trial with 30 participants to understand whether inhaled cannabis would help complicated cases where existing pharmaceuticals are ineffective or trigger adverse side effects.

MS is an unpredictable, often disabling disease of the central nervous system, which is made up of the brain and spinal cord.

The disease attacks the myelin, the protective covering wrapped around the nerves of the central nervous system, and — among other symptoms — can cause loss of balance, impaired speech, extreme fatigue, double vision and paralysis.

The average age of the research participants was 50 years with 63 per cent of the study population female.

More than half the participants needed walking aids and 20 per cent used wheelchairs.

Rather than rely on self-reporting by patients regarding their muscle spasticity — a subjective measure — health professionals rated each patient’s joints on the modified Ashworth scale, a common objective tool to evaluate intensity of muscle tone.

The researchers found that the individuals in the group that smoked cannabis experienced an almost one-third decrease on the Ashworth scale — 2.74 points from a baseline score of 9.3 — meaning spasticity improved, compared to the placebo group.

As well, pain scores decreased by about 50 per cent.

“We saw a beneficial effect of smoked cannabis on treatment-resistant spasticity and pain associated with multiple sclerosis among our participants,” says Dr. Jody Corey-Bloom of the university’s department of neuroscience.

Researchers found that, although generally well-tolerated, the cannabis had the expected short-term but acute cognitive effects.

Corey-Bloom says larger, long-term studies are needed to confirm findings and determine whether lower doses can result in beneficial effects with less cognitive impact.

The Multiple Sclerosis Society of Canada says Canadians have one of the highest rates of the disease in the world. The disease is the most common neurological diseases affecting young adults in this country and every day three more people in Canada are diagnosed with MS.

Source: Metronews.ca Copyright 2001-2012, Free Daily News Group Inc (15/05/12)

Biogen Idec announced that two new dosing innovations designed to help patients receiving once-a-week Avonex (interferon beta-1a) for relapsing forms of multiple sclerosis (MS) are now available in U.S. pharmacies:

-- The new Avonex PEN (Avonex 30mcg/0.5mL solution for injection) is the first intramuscular (IM) autoinjector for chronic use, designed to enhance the self-injection process for patients receiving Avonex therapy.

-- A new dose titration regimen, facilitated by the Avostartgrip titration devices, provides patients with the option to gradually increase the dose of Avonex at treatment initiation to reduce the incidence and severity of flu-like symptoms that patients may experience with therapy.

These product enhancements offer the potential for a more tolerable initiation and an easier injection process compared to the Avonex Prefilled Syringe.

"It is our priority to continue to improve our existing treatments like Avonex, which patients have relied on to effectively treat their MS since it was approved in the U.S in 1996," said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. "Avonex Pen has been shown to help reduce the anxiety patients may experience when self-injecting and for patients initiating treatment, titration can reduce the flu-like symptoms they may have when beginning Avonex therapy."

Avonex Pen is the first IM autoinjector approved in MS treatment. It was designed to enhance the self-injection process and features a substantially smaller needle than the Avonex Prefilled Syringe. The U.S. Food and Drug Administration (FDA) approved the Avonex Pen in February 2012 based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully. In this study patients felt significantly less injection pain after they switched from the Prefilled Syringe to Avonex Pen and the patients experienced reduced injection anxiety with Avonex Pen than with the Prefilled Syringe. Ninety-four percent of patients in the study also expressed a preference for Avonex Pen over the Avonex Prefilled Syringe. The top three reasons for this preference were ease of injection, reduction in pain and reduction in injection anxiety.

"One of the key aspects of treating MS is helping patients manage their treatment in order to get the most out of their therapy," said Peter B. Wade, M.D., medical director at the Joyce D. and Andrew J. Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research at Mount Sinai Rehabilitation Hospital in Hartford, Conn. "For many of my patients, Avonex Pen will help reduce injection-related anxiety and improve the self-injection experience."

The recently-approved Avonex Pen titration schedule can be facilitated by the Avostartgrip kit, a set of three devices that work with the Avonex Prefilled Syringe to administer the appropriate amount of medicine needed to titrate up to a full dose of Avonex over the course of three weeks. The FDA approved this titration regimen in February 2012, based on data from an eight-week, randomized, healthy volunteer study. It showed that a three-week titration period at treatment initiation reduced the severity of flu-like symptoms associated with Avonex treatment by 76 percent, as well as significantly reduced the incidence of flu-like symptoms, versus no titration four to six hours post-injection.

Patients who are new to Avonex treatment have the option to initiate therapy with the Avostartgrip titration kit; once patients have completed the titration regimen, treatment can be continued with Avonex Pen or other approved dosing options.

Avonex Pen is available from the same pharmacies patients currently fill their Avonex Prefilled Syringe prescriptions.

About Avonex Pen

Avonex Pen is the first single-use, once-a-week, fully integrated IM autoinjector for MS. It is designed for use with Avonex treatment in patients with relapsing forms of MS. Avonex Pen integrates the currently approved Avonex Prefilled Syringe and incorporates a smaller needle (25 gauge, 5/8 inch), which is thinner and 50 percent shorter than the standard Avonex Prefilled Syringe needle.

Additional features of Avonex Pen include: a protective injector shield that conceals the needle prior to injection; automated needle insertion and medication delivery; and a diameter and length designed to stabilize Avonex Pen during the injection procedure. In addition, Avonex Pen incorporates a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication.

The efficacy and safety of Avonex Pen was evaluated in an open-label, multicenter, Phase 3b study (n=70). Efficacy was assessed through objective and subjective assessments of key aspects of patients' use of Avonex Pen.

About Titration

The Avonex label provides physicians and patients with a clinically-supported schedule for gradually escalating the dose of Avonex at the start of therapy, which has been shown to reduce the incidence and severity of flu-like symptoms that can occur with Avonex treatment. In an eight-week, healthy-volunteer, randomized, Phase 1 study (n=234), a three-week titration period at the initiation of Avonex treatment reduced the incidence (odds ratio:0.18) of flu-like symptoms versus no titration four to six hours post-injection. It also reduced the severity of flu-like symptoms by 76 percent versus no titration four to six hours post-injection.

Titration with Avonex can be facilitated by the Avostartgrip kit, a set of three devices that work with the Avonex Prefilled Syringe to administer three titrated doses of Avonex over a three-week period: 7.5mcg, 15mcg and 22.5mcg. The full dose should be administered at week four.

A titration regimen should only be considered for patients initiating Avonex therapy. Once patients have completed the titration regimen, treatment can be continued with Avonex Pen or other administration options.

Avostartgrip titration kits are provided free of charge to patients who initiate treatment with Avonex.

Source: Market Watch Copyright © 2012 MarketWatch, Inc. (14/05/12)

Health services in the community are reaching breaking point in the UK, the Royal College of Nursing is claiming.

The union said evidence from its members showed cuts to councils and hospitals were over-burdening nurses in the community.

The research was released as nurses gather in Harrogate for their annual conference which will be addressed by the Health Secretary Andrew Lansley.

Ministers have said reforms to the NHS will improve services for patients.

RCN General Secretary Peter Carter said nurses were bound to "demonstrate their serious concerns" about the NHS in a Q&A session with Mr Lansley.

At last year's conference RCN members gave him a vote of no confidence.

The latest research was based on online feedback from nearly 2,700 nurses in the community including district nurses, those who work in GP practices and those who specialise in mental health.

Nine in 10 reported their caseloads had increased in the last year with some saying they were even having to fill in for council social care teams by making meals for patients and doing their shopping.

Ministers have talked about moving care away from hospitals and into the community so patients can get more appropriate services.

'Facade'
But the RCN said this was proving to be a "facade" as community services were "under-invested and over-burdened".

Many nurses claimed they were actually spending less time with individual patients because of the pressures being placed on them.

The union also released the latest data from its Frontline First campaign, which has been keeping track of job losses in the health service.

The figures, disputed by ministers, suggested more than 26,000 posts have gone in the last two years and predict another 34,000 are at risk over the next three years.

Mr Carter said: "Yet again and despite numerous warnings NHS organisations are making short-sighted cuts across the UK. Nurses are being stretched too thin and many are approaching breaking points."

'Worrying'
Over the weekend the RCN also released a report claiming hospital patients were being treated in corridors and being left waiting for hours on trolleys because trusts were struggling to cope with demands.

Shadow Health Secretary Andy Burnham said the RCN findings were "worrying" and showed the NHS was "coming under attack from every possible angle".

Health Minister Simon Burns said he did not recognise the figures on job losses.

He added: "We are giving nurses in hospitals and in the community more time to care. We want to remove excessive paperwork and bureaucracy. This government believes in the NHS."

Source: BBC News © British Broadcasting Corporation 2012 (14/05/12)

Disease progression, or gradual worsening, experienced by people who have multiple sclerosis usually occurs over many years, and it is difficult to track with the standard clinical measurement scales used by doctors to assess disease activity.

An international meeting was convened to determine how to improve clinical measures so that MS progression can be better tracked, especially during clinical trials of experimental therapies aimed at stopping progression. Better ways of measuring changes in disability will help to speed the development of new therapies for MS, in particular for progressive forms of the disease.

The meeting was organized by the International Advisory Committee on Clinical Trials in MS, an international group of MS experts jointly sponsored by the National MS Society and the European Committee for Treatment and Research in MS (ECTRIMS).* A summary of this meeting has now been published in Lancet Neurology (2012 May;11(5):467-476). The Society is responding to the group’s recommendations, and sponsoring a collaborative effort to revise one clinical measure for primary use as a means of measuring disability in MS studies.

The Meeting: The “International Conference on Disability Outcomes in MS” was held in Washington, D.C. in 2011. Over 70 experts in MS and clinical trial design from around the world – including academic physicians and scientists, representatives of companies pursuing new therapies in MS and regulators from the U.S., Europe and Canada – gathered to discuss the measures currently used to measure MS disability, including the Expanded Disability Status Scale (EDSS), and the MS Functional Composite (MSFC). They agreed that these measures do not adequately measure the changes in MS progression that occur over time, or the patients’ own perceptions of their health and quality of life.

The group reviewed disability rating methods that show promise but require more study, such as “composite” endpoints that combine several measures, and innovative tools such as smart phones and other instruments that may offer better ways of tracking a person’s mobility.

Imaging, such as sophisticated MRI techniques used to examine changes in MS in the brain and spinal cord, and techniques to assess changes in the visual system over time (such as optical coherence tomography, OCT), were also discussed in terms of their abilities to objectively track signs of disease progression.

Meeting participants also reviewed a variety of “patient reported outcomes” being explored in MS clinical trials. These are surveys of clinical trial participants’ perspectives of their own health status and response to therapies, and are increasingly incorporated into clinical trials in MS and many other disorders. These subjective measures can add a dimension of clinical relevance to the objective measurements used by physicians to assess disability and the effectiveness of therapies.

The attendees made recommendations for improving upon current measures. In the case of the EDSS, they recommended developing a standard interview script so that all clinicians would administer this scale similarly, and simplifying the complex scoring rules. In the case of the MSFC, the group recommended that the MSFC could be improved by the addition of a test that measures change in visual function over time, by replacing the currently used method of assessing cognitive function, and by developing alternative scoring methods.

Following the meeting, these recommendations were discussed by the National MS Society’s senior research advisors, who concluded that the Society should sponsor an effort to revise the MSFC. The advisors appointed an interdisciplinary group of people with expertise in the clinical trials arena, from academia, industry, regulatory agencies and patient advocacy groups. This team is shepherding the process of revising the MSFC scale for use as a primary disability outcome in MS clinical trials.

The goal is to speed clinical trials of promising therapies aimed at stopping progression or restoring function. “We can’t afford to wait years to determine whether a therapy is working against MS progression,” noted Timothy Coetzee, PhD, Chief Research Officer of the Society.

*Additional support for the meeting was provided by the Americas Committee for Treatment and Research in MS, MS International Federation, MS Society of Canada, Bayer Healthcare Pharmaceuticals, Inc., Biogen Idec, Inc., F Hoffmann-LaRoche Ltd., Genzyme Corporation, Novartis Corporation, Sanofi-Aventis SA, and Teva Pharmaceutical Industries Ltd.

Source: The US National MS Society (11/05/12)

Brave Graeme Scott is set to tackle some of the UK’s toughest mountains despite having multiple sclerosis.

Aged just 26, Mr Scott was diagnosed with the neurological condition, which can leave sufferers fatigued and facing problems with their walking and vision, in 2007.

The prospect of facing a life stuck in a wheelchair left him severely depressed and missing the great outdoors.

Now, however, with the help of a dozen friends and a specially-adapted wheelchair, he will take on one of the UK’s toughest challenges.

The 31-year-old will begin the Three Peaks Challenge next Saturday, aiming to climb the highest mountains in England, Wales and Scotland. Groups normally tackle the challenge in 24 hours, but Mr Scott and his friends are aiming to do it in 36.

Mr Scott, who works at Blacks outdoor shop in St Aldate’s, said: “Before my diagnosis, walking was a massive part of my life, I just loved being outdoors.

“Every single holiday and weekend was spent up on a hill or in woodland.

“I had plans to train for serious mountaineering, with hopes of going as far as climbing K2. But then in 2007 I was diagnosed with MS.”

Mr Scott, who lives in Witney, added: “It took me a long time and two or three relapses, which put me in the wheelchair, to come to terms with it.

“That sent me into quite deep depression. I always used to be outdoors and now I’m not. And I miss it.”

A number of relapses over the years left Mr Scott only able to walk short distances and confined to a wheelchair most of the time. He said: “This chair has difficulty making it over a grassy verge let alone a field, so the idea of going anywhere I used to love seemed out of the question.”

But an idea to turn his life around came on a recent visit to the pub with friends.

He said: “It started as a bit of a joke. We were talking about how much an all-terrain wheelchair would help me and someone mentioned the Three Peaks Challenge.

“Then the idea just stuck.”

So next week, a dozen friends and colleagues will “push, pull, drag, roll, haul and carry” Mr Scott to the top of Scotland’s Ben Nevis, England’s Scafell Pike and Snowdon in Wales.

The idea is to raise £4,000 to buy an all-terrain wheelchair, which would allow him to get back some of the freedom he lost.

He said: “It would give me back a huge amount of my life. It will get me outdoors doing what I love doing. And that means everything to me.”

To sponsor Mr Scott and friends, visit the Blacks store in St Aldate’s or call 01865 727632

Source: Oxford Mail © Copyright Newsquest 2001-2012 (11/05/12)

On May 10, the Food and Drug Administration issued a medical alert noting that individuals with multiple sclerosis should be aware of the risks of serious injuries and death associated with treatments for chronic cerebrospinal venous insufficiency—and that benefits of those treatments and promotion as an MS treatment “may lead people with the disease to make treatment decisions without being aware of the serious risks involved.”

As always, the Society of Interventional Radiology strongly urges close communications between doctor and patient. Those persons with MS are encouraged to talk to their interventional radiologists and their other doctors about any concerns or questions. SIR members—interventional radiologists who specialize in minimally invasive targeted treatments and who pioneered venous angioplasty and stenting—endovascular techniques that may be central to novel treatments for MS—may note an increase in calls from concerned individuals who have—or are seeking—treatment for CCSVI.

About 500,000 people in the United States have MS, and SIR understands the public’s desire to advance treatment for MS, generally thought of as an autoimmune disease in which a person’s body attacks its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI (a reported abnormality in blood drainage from the brain and spinal cord) in MS and its endovascular treatment (through a catheter placed in a vein to widen) by an interventional radiologist via balloon angioplasty and/or stents to open up veins could be transformative for patients and is being actively investigated.

The FDA communication is directed toward individuals with MS, health care providers including interventional radiologists, neurosurgeons and vascular surgeons) and clinical investigators. Health care providers were advised to inform patients that (1) there is conflicting evidence about CCSVI as a clinical entity, (2) CCSVI’s relationship to MS is scientifically unproven and (3) consensus on the diagnostic criteria of CCSVI has not been reached.

The FDA also indicated that it has not cleared or approved any angioplasty device or stents for CCSVI treatment and that the use of those devices in treating CCSVI is considered off label. “While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject,” stated the FDA announcement.

SIR supports and agrees with the FDA’s recommendations to encourage research on CCSVI and the current knowledge regarding the safety and effectiveness of treatment procedures. SIR also agrees that clinical research of CCSVI should be performed through well-designed clinical trials, which should require approval through the FDA investigational device exemption (IDE) program.

In 2010, the SIR published the position statement “Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association,” which specifically notes:

SIR recognizes the urgent need for more effective treatments for MS patients and the public’s interest in rapidly making such therapies available to this patient group.

SIR recognizes that patients with MS constitute a particularly vulnerable population, whose safety must be protected as new therapeutic approaches are evaluated.

At present, SIR considers the published literature to be inconclusive on whether CCSVI is a clinically important factor in the development and/or progression of MS and on whether balloon angioplasty and/or stent placement are clinically effective in patients with MS.

SIR strongly supports the urgent performance of high-quality clinical research to determine the safety and efficacy of interventional MS therapies and is actively working to promote and expedite the completion of needed studies.

SIR recognizes the challenge and the potential opportunity presented by promising early studies of an interventional approach to the treatment of MS. SIR is pleased that public advocacy groups have pushed the medical community forward to meet this challenge and is committed to assuming a national leadership role in launching needed efforts.

Interventional radiology is a recognized medical specialty requiring dedicated training that encompasses clinical patient evaluation and management, non-invasive venous imaging and the delivery of targeted, image-guided minimally-invasive treatments to patients. Interventional radiologists perform balloon angioplasty and stent placements on a daily basis in thousands of patients with diverse venous conditions, including acute deep vein thrombosis, post-thrombotic syndrome, superior vena cava syndrome and portal hypertension; they also perform procedures to maintain hemodialysis access. Interventional radiologists perform many of the CCSVI procedures in the United States; they are highly qualified to perform such treatments when appropriately indicated.

SIR will provide additional information for patients as it becomes available.

Source: Society of Interventional Radiology (11/05/12)

Relying too much on brain scans appears to be one reason doctors each year misdiagnose multiple sclerosis in hundreds of patients whose symptoms are caused by some other disease.

Researchers at Oregon Health & Science University and the Portland Veterans Affairs Medical Center surveyed 242 multiple sclerosis specialists in the U.S. to find out how often they see patients who have been misdiagnosed. Among the 122 respondents, more than 95 percent said they saw at least one patient in the past year diagnosed with MS by another medical provider, but the specialist "strongly felt" the patient had some other disease. Three out of four specialists said they saw three or more misdiagnosed patients within the past year.

The authors estimate that the 122 specialists saw 600 patients in a year who had been given an incorrect diagnosis of MS. An estimated 280 of the misdiagnosed patients were receiving therapy for MS with a disease-modifying drug, which can cause serious side effects and cost $40,000 or more per patient per year.

"Some of these patients have had this diagnosis for years," says lead author Dr. Andrew Solomon, an assistant professor at the University of Vermont College of Medicine, who began the research while he was at OHSU. "All of us had seen patients like this, who had a diagnosis of MS but we felt sure they did not have MS. That's what prompted this study."

MS is a chronic disease that attacks the central nervous system. Symptoms vary from mild numbness in the limbs to severe paralysis and loss of vision. The severity and progress of the disease vary unpredictably.

Doctors have no definitive blood test or imaging scan to confirm the diagnosis. They must take into account the patient's health history and performance on tests of movement, balance, vision, and mental function. Spinal fluid tests and MRI brain scans can be helpful.

The pattern of misdiagnosis revealed by the survey suggests that doctors are leaning too much on MRI findings, Solomon says.

That fits with previous reports, including a 2003 study in which two-thirds of the 281 patients referred for possible MS had other neurological conditions. Among the patients referred because of abnormal MRI results who did not have MS, 70 percent had a more obvious explanation for the abnormal MRI, including high blood pressure, migraine, or other neurological disease.

"MRIs are not a substitute for a good history and neurological examination in the diagnosis of MS," cautioned Dr. John R. Corboy of the University of Colorado Multiple Sclerosis Center and co-authors.

'Therapeutic frenzy'

Unnecessary use of powerful MS drugs on misdiagnosed patients was underway as early as 1997. In a review of 366 cases that year, Harvard Medical School neurologist Charles Poser found that 130 patients did not have MS, and 14 of them were receiving recombinant β-interferon treatment for MS. Another 10 misdiagnosed patients said their neurologist had recommended the treatment.

Back then, Poser speculated that marketing of the newly approved β-interferon had created a "therapeutic frenzy" that further propelled misdiagnosis. "I found that some patients referred to me with the diagnosis of multiple sclerosis had already been given these drugs, irrespective of the clinical characteristics of their disease," he wrote. "I have also noted that many patients who receive β-interferon do not have multiple sclerosis, and some patients started to take the drugs even after they were told that I could not confirm the diagnosis of multiple sclerosis."

Solomon and colleagues in Portland hope their survey points the way to improving diagnostic accuracy.

"We have lot of data on all of the problems that can be mistaken for MS," he says. "This provides a snapshot of what we are actually seeing in practice." The journal Neurology is publishing the study, funded by the Department of Veterans Affairs, the National Institutes of Health and the Partners MS Fellowship Award.

About one out of seven of the surveyed MS specialists who had identified a misdiagnosis said they did not always tell the patient. They reasoned that the patient wasn't receiving MS therapy and that changing the diagnosis might cause psychological harm.

The Colorado study found that psychiatric disorders were the root of the problem for more than one-fifth of patients referred for possible MS. "These patients often go from physician to physician, using significant resources, not getting appropriate evaluation and treatment, and undergoing great emotional distress," Corboy and colleagues noted.

Dr. Dennis Bourdette, director of the OHSU Multiple Sclerosis Center and co-author of the new survey, says misdiagnosed patients remain at risk of getting a harmful treatment, while being deprived of treatment likely to help. Money wasted as a result of misdiagnosis is hard to count but would surpass $11 million a year just on medical treatment of cases identified in the survey.

Source: Oregon Live.com © 2012 Oregon Live LLC. (09/05/12)

The U.S. Food and Drug Administration is alerting health care professionals and patients1 about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

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

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

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

MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.

Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.

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

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

Source: FDA (09/05/12)

Both U.S. and European regulators have accepted for review Biogen Idec's application for experimental multiple sclerosis drug BG-12, the company said on Wednesday.

The pill is seen by some Wall Street analysis as having the potential to become the world's leading treatment for the chronic, disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

Biogen already makes multiple sclerosis drugs Avonex and Tysabri, which are given by injection.

The company said the U.S. Food and Drug Administration granted a standard 10-month review for BG-12 and the European regulatory agency has validated its application. Both applications were submitted in the first quarter of this year.

Source: Reuters © 2012 Thomson Reuters (09/05/12)

For people living with Multiple Sclerosis, some of the simple things many of us take for granted can be daunting. And, too often that leads to a withdrawal of activities for the person living with the disease.

A group of local researchers is trying to change that by helping MS patients stay mobile one step at a time.

With every step, Rob Loewen is fighting to keep his independence. He was diagnosed with Multiple Sclerosis in 1992 but says he's been living with the symptoms much longer-symptoms that have made life a challenge.

"You plan a day and think here's a few things I want to achieve today. And at the end of the day, you say, I did nothing. That's pretty hard to live with," says Loewen.

It's Loewen's determination to stay active that has led him to be screened for a new pilot project in Saskatoon. Researchers are working with MS patients to maintain their independence by engaging in exercises that promote mobility and help them with everyday activities.

"In this particular case, regular mobility involves us doing things we take for granted, like getting across a crosswalk in time, getting up a flight of stairs without having to hold onto a handrail," says lead researcher with the project Larry Brawley.

Brawley says those seemingly easy tasks can be daunting for MS patients. And, too often, that results in a loss of confidence and a withdrawal from activities all together. "Our motto here would be rather than run, our motto for this program would be we'd like to get people to walk before they run to make sure their mobility is preserved."

Dr. Katherine Knox is the director of the Saskatoon Multiple Sclerosis Clinic. She says preserving that mobility is especially important as MS is a progressive disease.

"People who maintain an active lifestyle and activity program that focuses on maintaining balance, range of motion and aerobic conditioning, they tend to live better with their disease," says Dr. Knox.

People like Rob Loewen. Although he has good days and bad, he applauds any effort to help those in similar situations stay on their feet, and fight MS, every step of the way.

"I'm always looking for the next challenge to enhance my quality of life and there's no shortage of those," says Loewen.

Source CTV News © 2012 CTV Bell Media (09/05/12)

The health system in the UK cannot cope with the rising number of under-65s with long-term medical conditions and needs "radical change", says a study in The Lancet.

A team of researchers analysing 1.75 million people in Scotland found that nearly a quarter had two or more chronic diseases.

Their care was often co-ordinated poorly and inefficient, the study said.

The team wants a more personal approach to patients with complex problems.

At present, healthcare services, medical research and the education of medical students are dominated by a focus on individual diseases, the study authors say.

Yet rising numbers of people are living with more than two long-term disorders, called "multimorbidity", which could include coronary heart disease, diabetes, cancer, stroke and depression.

In general, people with multimorbidity are more likely to live in deprived areas and have a poorer quality of life. Their care is fragmented because they see a number of different specialists.

Generalist approach
The study, led by Bruce Guthrie, professor of primary care medicine at Dundee University, Professor Stewart Mercer, of Glasgow University, and Graham Watt, professor of general practice at Glasgow, says this approach should change.

"Existing approaches need to be complemented by support for the work of generalists, providing continuity, co-ordination, and above all a personal approach for people with multimorbidity."

Their study of nearly two million patients registered with 314 medical practices in Scotland showed that people living in the most deprived areas were particularly affected by long-term physical and mental disorders.

These disorders were more common among poorer communities and occurred 10-to-15 years earlier than among those living in affluent areas.

The study looked for 40 chronic conditions among the participants' data.

Researchers found that 42% of patients had one or more conditions and 23% had two or more.

It also found that only 9% of those with coronary heart disease, had that one disease alone.

Similarly, only 23% of those with cancer, had only cancer and no other long-term disease.

'Wake-up call'
Although the prevalence of multimorbidity increased with age and was present in most people aged over 65, the actual number of people with multimorbidity was higher in those under 65, the study said.

Graham Watt, professor of general practice at Glasgow University, said this was a problem affecting many countries, not just Scotland.

"Any country with an ageing population is heading in this direction. All these countries are waking up to the problem.

"The status quo isn't an option because it leads in the wrong direction."

Prof Watt said that rather than more specialists, patients with multiple conditions "need someone who can oversee all the problems of a patient".

"These patients need continuity, and we need ways of measuring how well care is joined-up."

Financial burden
In an accompanying article in The Lancet, Dr Chris Salisbury, from the School of Social and Community Medicine at the University of Bristol, said the increasing proportion of people with several co-existing medical problems had a financial impact.

"Expenditure on health care rises almost exponentially with the number of chronic disorders that an individual has, so increasing multimorbidity generates financial pressures. This economic burden heightens the need to manage people with several chronic illnesses in more efficient ways," said Dr Salisbury.

Dr Salisbury suggests that general practitioners in more deprived areas should have lower caseloads to account for higher levels of multiple morbidity.

He also says that in hospitals, those with multimorbidity should be assigned to a generalist consultant who would be responsible for co-ordinating their care.

The Scottish Government's Health Secretary, Nicola Sturgeon, said: "We are working in partnership with NHS, primary-care providers and patients, as well as the research community, so that we have effective systems in place to address the needs of people with multiple health conditions and to reduce these health inequalities."

Source: BBC News © British Broadcasting Corporation 2012 (10/05/12)

Diagnosed with the debilitating condition when they were only in their thirties, three women tell Stephanie Bell what it’s like depending on your children to care for you.

They are the mums who have had to cope with their worlds spinning out of their control. Struck down in their prime by the cruel condition multiple sclerosis, today three mums talk about how they are finding the strength to fight back against an illness which has robbed them of so much of their independence.

Multiple sclerosis strikes twice as many women as men and Northern Ireland has one of the highest rates in the world.

It is usually in their 20s and 30s, at a time when most women are settling into their careers and starting their own families, that they are hit by this devastating neurological disorder.

Not only does it often mean an end to their working life but, as our mums reveal, it can leave them so helpless some days that they cannot even care for their own children.

MS is a disorder of the central nervous system. Symptoms can attack at random, resulting in problems with mobility and balance, eyesight, memory and thinking, bladder control and extreme fatigue. As well as coping with the terrible pain and impact on their everyday family lives, sufferers also have to contend with a shocking lack of understanding by people outside of the home.

Hurtful remarks, strange looks and even being mistaken for being drunk is part of the appalling attitude which people with the condition encounter from strangers.

Patricia Gordon, director of the MS Society NI, says: “Because it’s poorly understood, living with MS can turn a simple shopping trip or social event into an ordeal — where strange looks and hurtful remarks can all be part of daily life.”

Three local mums who have shown remarkable courage in fighting back against the condition share their stories of the harsh reality of living with multiple sclerosis.

‘When I can’t cope, my son becomes my legs’

Pauline Ward (44), from Derriaghy, is a midwife and single mum to Connla (11) and was diagnosed with relapsing MS in 2004. She says:

I was living in Germany in 2004 when I developed back pain and at first it was thought I had a prolapsed disc. Then one day I couldn’t lift my foot to put it on the accelerator of the car.

Doctors thought I had a trapped nerve and I had surgery and everything was fine for a month and then I started trailing my foot.

I then asked to see a neurologist and five days later I was told it was MS.

I was relieved to know what was wrong but it was still a shock and very frightening.

I didn’t want to know too much about it then as I knew some people became dependent on wheelchairs and I didn’t want to think about that.

I suppose I didn’t want to scare myself anymore by reading up on it.

Two years ago I was told that my condition had become ‘secondary progressive’ which meant it had worsened and has left me depending on crutches to get about.

I try to live as normal a life as possible and have been lucky to have been able to keep my job on as a midwife in the ante-natal unit of the Royal Jubilee Maternity Hospital, even though it is a struggle and usually leaves me exhausted.

The hardest part for me is that Connla has to do things which normally an 11-year-old shouldn’t have to deal with, like carrying in my shopping, cutting the grass and taking the clothes out of the tumble dryer, things that I can’t manage.

There are some days when I find the stairs difficult to manage or walking a major hurdle and then Connla is my legs.

It upsets me that I can’t kick a football around with him and he has asked me a couple of times why I can’t be normal like other mummies.

It is very frustrating for both of us and Connla gets angry with the MS.

I try to keep as positive an attitude as I can — you just have to.”

‘There are days when I paint on my happy face’

Linda Watson (39), a former hairdresser from Bangor, was diagnosed with relapsing MS in 2009. She is married to Darren (40), a bus driver, and has two children, Chloe (14) and Jamie (16). She says:

Some days I feel like screaming but I’ll always fight back against MS. I had been experiencing fatigue, dizziness, mobility and speech problems for a number of years but always put it down to the pressures of working in a busy hairdressing salon.

I didn’t know much about MS before I was diagnosed so it never really crossed my mind. Then I temporarily lost the sight in my left eye which was terrifying. I was hospitalised and after a number of tests I was eventually diagnosed.

I refused to accept it initially. I didn’t think it could happen to me. I tried to find another reason for my symptoms. My husband Darren was really supportive and helped me to come to terms with it and learn more about it. I’ve found it difficult because many people don’t understand MS. They think because you look well, that you can’t be feeling unwell and that can be frustrating.

Every single day I experience pain and fatigue. It is constant and it would be very easy to feel down about it and give up but I have my kids and lovely husband to keep me going. They help me to fight back by helping me to stay positive and living my life to the full.

Having to give up my career was terrible as my job was my world. At 37 you don’t expect to be finishing work for good — you expect to have another 30 years at least in you.

As a mum it’s the simple things like not being able to make breakfast or get the kids’ uniforms ready before they go to school which is hard. My husband is brilliant but it is frustrating not being able to care for your kids the way you want to.

I am in a wheelchair most of the time although I will use a walking aid around the house. I try to keep smiling. There are many days when my happy face is just painted on as I try not to let how I’m feeling show. There are a lot of people out there who are a lot worse off than me and so I try to make the best of it. There is no cure for MS yet but that’s not an excuse. I have no choice; I just have to keep fighting back.”

‘Some days making a cup of tea is too much’

Madeline McBride (42), a former childminder, was diagnosed with MS in 2004. She lost a sister to MS and has a brother and another sister with the condition. She and her husband Raymond (43), a production worker, have five children, Caoimhe (19), Baolan (18), Roisin (16), Ellen (14) and Eoin (10). She says:

I had been experiencing a range of symptoms including numbness in my face, fatigue, pain and mobility problems. My husband and I would go out walking and I kept tripping up and losing co-ordination. I wasn’t sure why it was happening. My sister Clare was diagnosed with MS at the age of 16 so it was always in the background but I really wasn’t convinced that I had MS.

I visited my doctor but there was no conclusive diagnosis and I just tried to carry on as normal. With five children, we have a busy house and I just didn’t have the time to allow these suspicious symptoms to hold me back.

However, the numbness and fatigue continued. I had a lot of pain and eventually my doctor advised me to go to see a neurologist, who conducted a number of tests.

In many ways my diagnosis was frighteningly quick. I really wasn’t expecting it to be MS and it was a big shock for my husband Raymond, because I’d tried to hide my pain and no one really knew the extent of it.

Sadly my sister died six months after my diagnosis and another brother and sister have since been diagnosed. I’m very independent and I want to be strong for myself and my family so I just take each day at a time.

Living with MS can be so unpredictable and frustrating. Some days I just forget I can’t do all the things I want to. Simply making a cup of tea can be too much and I just have to admit I need more help than I used to. I’m very lucky that my husband Raymond and all my children are very supportive and help out around the house. It was tough giving my job up and financially it put a lot of pressure on us.

I fight back against my MS by maintaining a positive attitude and trying to maintain as much normality as I can. At the end of the day I’m still a mum so I try to do the housework and everything an average mum does.

Living with MS can be difficult but I won’t let it get the better of me. It’s all about being positive and never giving up. My dad Joe, husband Raymond and children Ellen, Roisin and Eoin and nephew Oisin are taking part in the Belfast City Marathon to raise funds for the MS Society NI.”

the prejudices sufferers face...

A disturbing report by the MS Society has revealed that many people are “narrow minded” and “ignorant” in their attitude towards those with disability.

More than 2,000 people were surveyed for the report ‘Fighting Back — ordinary people battling the everyday effects of MS’.

It revealed that as many as one in five (21%) think disabled people need to accept they cannot have the same opportunities in life as non-disabled people and one in four (24%) believe disabled people often exaggerate the extent of their physical limitations.

A separate poll of people with MS showed that as many as 42% feel that people often don’t consider them as equal.

Over half (53%) said their symptoms have been mistaken for drunkenness, while three quarters (76%) have experienced someone questioning the fact they have MS because they ‘looked well’.

Source: Belfast Telegraph © Belfasttelegraph.co.uk (09/05/12)

Background. Recombinant T-cell receptor ligand 1000 (RTL1000) is a single-chain protein construct containing the outer two domains of HLA-DR2 linked to myelin-oligodendrocyte-glycoprotein- (MOG-) 35-55 peptide. Analogues of RTL1000 induce T-cell tolerance, reverse clinical and histological disease, and promote repair in experimental autoimmune encephalomyelitis (EAE) in DR2 transgenic, C57BL/6, and SJL/J mice.

Objective. Determining the maximum tolerated dose, safety, and tolerability of RTL1000 in multiple sclerosis (MS) subjects.

Methods. This was a multicenter, Phase I dose-escalation study in HLA-DR2(+) MS subjects. Consecutive cohorts received RTL1000 doses of 2, 6, 20, 60, 200, and 100 mg, respectively. Subjects within each cohort randomly received a single intravenous infusion of RTL1000 or placebo at a 4 : 2 ratio. Safety monitoring included clinical, laboratory, and brain magnetic resonance imaging (MRI) evaluations.

Results. Thirty-four subjects completed the protocol. All subjects tolerated the 2-60 mg doses of RTL1000. Doses ≥100 mg caused hypotension and diarrhea in 3 of 4 subjects, leading to discontinuation of further enrollment.

Conclusions. The maximum tolerated dose of RTL1000 in MS subjects is 60 mg, comparable to effective RTL doses in EAE. RTL1000 is a novel approach for MS treatment that may induce immunoregulation without immunosuppression and promote neural repair.

Yadav V et al. Recombinant T-Cell Receptor Ligand (RTL) for Treatment of Multiple Sclerosis: A Double-Blind, Placebo-Controlled, Phase 1, Dose-Escalation Study. Autoimmune Dis. 2012;2012:954739. Epub 2012 Apr 5.

Comment

For T cells to be activated they must see the antigenic peptide (a fragment of a protein, such as a myelin protein) in the context of major histocompatibility complex in addition to co-stimulatory signals provided by molecules such as CD80 and CD86. However it the T cell does not get the costimulatory signals it either triggers the T cell to be silenced by a process called anergy, of the cells are stimulated to commit suicide. It only does this and would not be expect to have any side-effects, unlike current immunosuppressive drugs that removes alot of the immune repertoire and can lead to increased susceptibility to infection. It is clear from genetic studies that HLA-DR2 is a variant of the major histocompatibility complex that is a predisposing susceptibility factor for MS. This molecule is common in Northern Europeans and accounts for a reason why MS is more common in Northern Europeans.

This HLA-DR2 molecule has been linked to a myelin peptide (a small stretch of amino acids) with the idea that this drug called RTL1000 will inhibit myelin-reactive T cells. They have shown that this works in mice and can inhibit MS-like disease from developing. However, I believe the efficacy claims are wildly exaggerated. In my opinion there is absolutely no reason why this molecule would promote repair and remyelination directly. However because it inhibited the damaging immune response it may of allowed the natural repair processses to do some repair, but this is very differnt from the the drug actually causing repair as implied.

This new drug has passed through its first test in humans, the next one will be do this in MSers. Whilst this paper is perhaps and advertisement for investors, it has to be said the authors have declared conflicts of interest,as long as your arm, because the are recieving stuff for doing the study. However this all transparent and above-board. If MS is not autoimmune then the approach will fail.

Source: MouseDoctor Blog (09/05/12)

GW Pharmaceuticals plc and Almirall S.A. today announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).

Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex® to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex® meets their requirements for approval. The countries involved in the MRP and in which Sativex® is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.

"For Almirall, the successful completion of this second MRP regulatory process for Sativex® represents very good news and reinforces our commitment to expand this innovative medicine to MS patients across Europe. Sativex® is the first treatment specifically indicated for the treatment of spasticity, and related symptoms, in MS patients" said Bertil Lindmark, Chief Scientific Officer at Almirall.

The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, each country is then expected to issue a national marketing authorisation. Launch timing in these ten new countries is dependent on national pricing and reimbursement procedures. Launches are anticipated from the end of 2012 onwards.

Dr Stephen Wright, GW's R&D Director, said, "Today's news means that regulatory authorities in a total of eighteen European countries have now recommended Sativex® for approval. The successful outcome of this most recent regulatory process provides further endorsement of the quality, safety and efficacy of Sativex®. Sativex® has an important role in meeting the needs of people with Multiple Sclerosis and we look forward to working with our partners Almirall to make the medicine available to patients across Europe."

In Europe, Sativex® is approved and marketed for MS spasticity in the UK, Spain, Germany, and Denmark. In addition to the ten new European markets included in this MRP, launches are also currently being planned in Sweden, Italy, Austria and the Czech Republic.

In addition to MS spasticity, Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.

Source: GW Pharmaceuticals plc (08/05/12)

The leading physicians from Accentia Biopharmaceuticals, Inc. and Johns Hopkins University have presented plans for a randomized clinical trial to study Cyrevia (formerly Revimmune) in multiple sclerosis (MS) to a number of key opinion leaders in the field and potential site investigators. Johns Hopkins University will serve as the lead trial site for the study.

Physicians also co-hosted a meeting with prospective clinical trial investigators at the recent American Academy of Neurology (AAN) Annual Meeting in New Orleans.

A group of invited key opinion leaders and neurologists from leading Multiple Sclerosis Centres of Excellence attended the Cyrevia investigators meeting, hearing presentations from two Johns Hopkins physicians: Douglas E Gladstone, MD, associate professor of Oncology, clinical director in-patient/out-patient programme (IPOP), Sidney Kimmel Comprehensive Cancer Centre; and Daniel M Harrison, MD, assistant professor of Neurology. Drs Gladstone and Harrison reviewed multiple open-label phase II Cyrevia studies conducted at Johns Hopkins, demonstrating significant benefit for Cyrevia versus historical outcomes in the treatment of a range of autoimmune diseases, and jointly proposed a controlled, randomized, multi-centre phase III MS study.

“It was a great privilege to hear positive feedback from such an esteemed group of leading MS physicians, and we look forward to making a formal announcement as to the institutions that will participate in our planned Cyrevia clinical trial,” stated Samuel S Duffey, Esq., Accentia’s president and CEO. “In particular, we found tremendous enthusiasm for a single course of Cyrevia therapy administered over four consecutive days that offers patients the potential to 'reboot' their immune system in order to reduce their disability.”

As a novel system of care to treat multiple sclerosis, Cyrevia (high-dose Cytoxan or “HiCy”) temporarily, but almost completely, eliminates circulating white blood cells, including autoimmune disease cells, while sparing the immune stem cells in the bone marrow. Following Cyrevia, the immune system reforms, only with new white blood cells derived from these stem cells, in effect “rebooting” itself and reestablishing an immune system without a large population of autoimmune cells. Cyrevia therapy includes a comprehensive risk management program (REMS) to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

Source: Pharmabiz.com Copyright © 2010 Saffron Media Pvt. Ltd (08/05/12)

A new oral drug to treat the symptoms of Multiple Sclerosis, which has been licensed and deemed cost-effective here, remains unavailable to sufferers.

The final stage in the HSE’s process before which it could be prescribed was “neither fair nor transparent”, a leading neurologist has said.

Prof Orla Hardiman, consultant neurologist at Beaumont Hospital in Dublin, said the MS drug Gilenya had been assessed and deemed cost-effective at the National Centre for Pharmacoeconomics (NCPE) in St James’s Hospital, Dublin.

Any pharmacological company seeking to have a new drug reimbursed for patients under the Community Drugs Schemes must first have its cost-effectiveness assessed by the centre.

Speaking on RTÉ radio yesterday, Prof Hardiman said the new drug was the first of a new generation of MS drugs that could be taken orally. “It looks like it’s going to be very effective.”

It would be prescribed to people already on injectable drugs for relapsing and remitting MS and for whom the drugs were not working effectively. Prof Hardiman said about 1,000 of the 6,000 or so MS sufferers here would benefit.

“It has been approved across Europe actually and we are one of the last countries where funding is a problem,” she said.

“There is a kind of a go-slow across the sector in terms of anything that might cost money.”

She said Gilenya would replace another drug so the extra cost would be “minimal”. There had to be a system that was “fair and transparent”.

“But the point at which drugs become available, when they reach the queue post the analysis, that’s not transparent . . . It’s not clear how the drug progresses from the top of the list into becoming available, and that’s a thing of grave concern to many of us in practice.”

There seemed to be another process, “whereby if you have an advocate, if you have a condition that generates a certain amount of sympathy through advocacy, that that’s the system to get the drug through”.

A spokeswoman for the HSE said there were a number of drugs, including for the treatment of MS, going through the process of approval. She said the assessment process was “well-established and has been in place for a number of years”.

Source: Irishtimes.com © 2012 irishtimes.com (08/05/12)

Abstract
Multiple sclerosis (MS) is a disease with multiple etiologies. The most recent theory of the vascular etiology of MS, Chronic Cerebrospinal Venous Insufficiency (CCSVI), suggests that cerebral venous obstruction could lead to cerebral venous reflux, promoting local inflammatory processes.

This review article offers strong evidence that the route of the observed narrowing of cerebral veins arises from autonomic nervous system dysfunction, particularly cardiovascular autonomic dysfunction.

The dysfunction of this system has two major effects: 1) the reduction of mean arterial blood pressure, which has the potential to reduce the cerebral perfusion pressure and the transmural pressure, and 2) the failure of cerebral autoregulation to maintain constant cerebral blood flow in the face of fluctuations in cerebral perfusion pressure. Alterations in cerebral autoregulation could in turn raise the critical closure pressure, indicated to be the cerebral perfusion pressure at which the transmural pressure will be sub-sufficient to overcome the active tension imparted by the smooth muscle layer of the vessel. These two effects of autonomic nervous system dysfunction (reduction in arterial blood pressure and alterations in cerebral autoregulation), when combined with inflammation-induced high levels of nitric oxide in the brain, will lower transmural pressure sufficiently to the point where the threshold for critical closure pressure is reached, leading to venous closure.

In addition, cerebral vessels fail to overcome the closure as a result of low central venous pressure, which is also regulated by autonomic nervous system function. Furthermore, through their neuroregulatory effects, infectious agents such as the Epstein-Barr virus and vitamin D3 are able to alter the functions of the autonomic nervous system, influencing the rate of CCSVI occurrence.

The absence of CCSVI specificity for MS, observed in recent clinical studies, may stem from a high prevalence of autonomic nervous system dysfunction in control groups which were recruited to these studies. Future studies should investigate CCSVI in relation to cardiovascular autonomic function.

Abbreviations
ANS, autonomic nervous system; BBB, blood brain barrier; BP, blood pressure; CCSVI, chronic cerebrospinal venous insufficiency; CIS, clinically isolated syndrome; CP, chronic progressive; CrCP, critical closure pressure; EBV, Epstein-Barr virus; EDSS, expanded disability status scale; HR, heart rate; IJV, internal jugular vein; MBP, myelin basic protein; PTA, percutaneous transluminal angioplasty; RR, relapsing remitting; SLE, systemic lupus erythematosus; Vit D, 1,25-dihydroxyvitamin D

Zohara Sternberg, Department of Neurology, Baird MS center, Jacobs Neurological Institute, 100 High St. Buffalo, NY 14203, USA

Full Article

Source: Autoimmunity Reviews Copyright © 2012 Published by Elsevier B.V. (08/05/12)

Multiple sclerosis involves demyelination and axonal degeneration of the central nervous system. The molecular mechanisms of axonal degeneration are relatively unexplored in both multiple sclerosis and its mouse model, experimental autoimmune encephalomyelitis.

We previously reported that targeting the axonal growth inhibitor, Nogo-A, may protect against neurodegeneration in experimental autoimmune encephalomyelitis; however, the mechanism by which this occurs is unclear.

We now show that the collapsin response mediator protein 2 (CRMP-2), an important tubulin-associated protein that regulates axonal growth, is phosphorylated and hence inhibited during the progression of experimental autoimmune encephalomyelitis in degenerating axons.

The phosphorylated form of CRMP-2 (pThr555CRMP-2) is localized to spinal cord neurons and axons in chronic-active multiple sclerosis lesions. Specifically, pThr555CRMP-2 is implicated to be Nogo-66 receptor 1 (NgR1)-dependent, since myelin oligodendrocyte glycoprotein (MOG)35–55-induced NgR1 knock-out (ngr1−/−) mice display a reduced experimental autoimmune encephalomyelitis disease progression, without a deregulation of ngr1−/− MOG35–55-reactive lymphocytes and monocytes.

The limitation of axonal degeneration/loss in experimental autoimmune encephalomyelitis-induced ngr1−/− mice is associated with lower levels of pThr555CRMP-2 in the spinal cord and optic nerve during experimental autoimmune encephalomyelitis.

Furthermore, transduction of retinal ganglion cells with an adeno-associated viral vector encoding a site-specific mutant T555ACRMP-2 construct, limits optic nerve axonal degeneration occurring at peak stage of experimental autoimmune encephalomyelitis.

Therapeutic administration of the anti-Nogo(623–640) antibody during the course of experimental autoimmune encephalomyelitis, associated with an improved clinical outcome, is demonstrated to abrogate the protein levels of pThr555CRMP-2 in the spinal cord and improve pathological outcome.

We conclude that phosphorylation of CRMP-2 may be downstream of NgR1 activation and play a role in axonal degeneration in experimental autoimmune encephalomyelitis and multiple sclerosis. Blockade of Nogo-A/NgR1 interaction may serve as a viable therapeutic target in multiple sclerosis.

Full text

Steven Petratos, Ezgi Ozturk, Michael F. Azari, Rachel Kenny, Jae Young Lee, Kylie A. Magee, Alan R. Harvey, Courtney McDonald, Kasra Taghian, Leon Moussa, Pei Mun Aui, Christopher Siatskas, Sara Litwak, Michael G. Fehlings, Stephen M. Strittmatter and Claude C. A. Bernard

Source: Brain Copyright © 2012 Guarantors of Brain (08/05/12)

Two major medical and cultural societies in Kuwait have joined hands with local experts to raise awareness of the neurological disorder Multiple Sclerosis (MS) through a series of educational talks.

“Most of the MS information on the Internet is available only in English, which makes it difficult in predominantly Arabic-speaking populations like Kuwait to keep the patients and public informed,” said Dr Raed Al Roughani, senior neurology specialist in Al Amiri Hospital, Kuwait City, at one of the talks organised by the Kuwait Multiple Sclerosis Association (KMSA) and Kuwait Women Cultural and Social Society (KWCSS).

“We are finding more and more that they use blogs and forums with non-approved medical information as the basis for their choices.”

“Also we’re finding that many people are afraid of being diagnosed with an illness, so while they know that they are exhibiting symptoms that are unusual, they will not go seek a diagnosis out of fear. This is why these talks are so very important,” Dr Al Roughani added.

“The first educational forum hosted on April 15 with MS patients and their families was a great success. Dr Al Roughani answered questions from patients and their families about the best and latest treatments for MS as well as explaining the importance of psychological care for patients to improve their quality of life – information they all quite desperately needed,” said Mona Al Musaireei, chairperson of the KMSA.

The second educational forum that took place yesterday (May 2) evening focused on the critical importance of MS awareness of patients and primary health care providers, to help diagnose the disease, said Al Musaireei.

“There are up to 1,400 patients in Kuwait with MS and our recent results have shown that about 40 per cent are not fully adherent with their current medication regimen. This is a result of the undesirable side effects of some drugs and also a perceived lack of efficacy – the patients believe that the drug has no effect,” said Dr Al Roughani.

Kuwait’s Ministry of Health licensed the world’s first oral medication for the relapsing remitting form of MS last year, which affects around two-thirds of those diagnosed with the disease. Local doctors said that this new treatment option would help improve the quality of life and medication for patients in the country.

Existing treatment includes the need for patients to undergo regular injections, which can cause flu-like symptoms for 24 hours and leave red marks on the skin. The new oral treatment would remove the need for these regular injections.

Research figures show MS affects around 25 to 50 people in every 100,000 in Arabic populations and about 100 per 100,000 in Northern Europeans who display the highest risk of MS across the world, with prevalence seeming to increase with further distance from the equator.

MS is a nervous system disease with no known cause that affects the brain and spinal cord, leading to symptoms such as visual disturbances, muscle weakness, trouble with coordination and balance, sensations such as numbness, prickling or "pins and needles" and thinking and memory problems.

Globally MS affects women more than men and often begins between the ages of 20 and 40. The disease can be mild but some people lose the ability to write, speak or walk. There is no cure for MS but medicines can slow disease progression and help control symptoms.

Source: TradeArabia News Service Copyright (c) 2012, Al Hilal Publishing & Marketing Group (03/05/12)

Disturbing findings published in a new report have revealed that too many people are ignorant and narrow-minded when it comes to considering the lifestyle people with disabilities, such as multiple sclerosis (MS), can lead.

Fighting Back – ordinary people battling the everyday effects of MS, was launched on Monday by the MS Society to mark MS Awareness Week this week.

It highlights the impact MS has on people’s emotions and relationships, social life and work life. It also reveals the full extent of alarming stigmas and negative attitudes that exist towards disabled people.

Over 100,000 people in the UK are living with MS. In Northern Ireland, more than 4,000 people are affected by the neurological condition, one of the highest prevalence rates in the world.

A ComRes poll, commissioned for the report, of more than 2,000 British adults shows one in five (21 per cent) people think disabled people need to accept they cannot have the same opportunities in life as non-disabled people and one in four (24 per cent) believe disabled people often exaggerate the extent of their physical limitations.

A separate poll of over 1,400 people with MS reveals as many as 42 per cent of people with MS feel that, as a result of their condition, people often don’t consider them as equal, while almost one in three (30 per cent) even say they have been visibly ignored because of their condition.

It’s likely that such shocking statements are largely due to the lack of public understanding about disability, and MS in particular. The research shows 71 per cent of British adults admit they don’t feel they know enough about MS – and even among people who know someone with MS, understanding of the condition is still poor. Over half (53 per cent) of people with MS surveyed say their symptoms have been mistaken for drunkenness, while three quarters (76 per cent) have experienced someone questioning the fact they have MS because they ‘looked well’.

Multiple sclerosis affects the central nervous system and is usually diagnosed in people in their 20s and 30s. Symptoms can attack at random, resulting in problems with mobility and balance, eyesight, memory and thinking, bladder control and extreme fatigue. Around twice as many women as men have MS.

Patricia Gordon, director of the MS Society NI, said: “Because it’s poorly understood, living with MS can turn a simple shopping trip or social event into an ordeal – where strange looks and hurtful remarks can all be part of daily life.

“Yet people with MS have the same aspirations as anyone else. Most want loving relationships, an active social life and a successful career – and they can have this, given the right support and understanding. Of course MS presents many challenges, but society can place further unnecessary barriers in the way of people with MS, making it harder than it needs to be to live a full life.”

With such stigma and misunderstanding it’s no surprise that people with MS find it hard to talk about their condition with others: almost one in three people with MS surveyed (30 per cent) say they often avoid telling people they have the condition. This extends to the workplace too, with 42 per cent of people admitting to being concerned about telling their employer they have MS in the current economic climate.

More positively, many people with MS (41 per cent) have found the condition has had a positive impact on relationships with their immediate family, almost half (49 per cent) say it has led them to take up new hobbies and interests, and over a third (37 per cent) of employed people with MS feel their condition does not impact on their work

Thirty-four-year-old mother-of-two Tracey Orriss, who is a member of the MS Society Newry branch, says that she found it difficult to accept that she wasn’t always going to be able run around the garden with her children.

She was diagnosed with relapsing remitting MS last year, and admits she was shocked and deflated by her diagnosis.

“In my late 20s I started to experience extreme fatigue, back problems and mobility problems,” she says.

“It was so bad that I ended up on crutches during my pregnancy. At the time it was always assumed that it something else. My symptoms would come and go but it just seemed to get worse. Eventually I was admitted to hospital and had an MRI scan. It showed damage to my spine, back and brain and indicated MS. It was an extremely frightening experience but in many ways my diagnosis was a relief because I finally understood my symptoms.

“I worried about whether I would be able to be a full time mum for my two children and I worried that people would pity me when they found out. I didn’t want to use a walking stick and as a young woman it was hard to adjust to this. Nevertheless, I soon realised that living with MS would mean that I have to accept more help. I have severe back pain and I find it difficult to do everyday tasks like lifting the phone and making a cup of tea but my partner Gareth is such a big support.

“He helps me to fight back against MS by staying fit and active. Gareth is competing in the Camlough Triathlon in June to raise funds for the MS Society NI. He helps me by training with me at the gym. I find keeping active helps me to sleep better and manage my symptoms. I’ve also joined Slimming World to try and lose some weight and I’ve lost 8lb already. I feel healthier and more positive.”

Another local woman diagnosed with relapsing remitting MS was Linda Watson, from Bangor.

The former hairdresser, 39, had been experiencing fatigue, dizziness, mobility and speech problems for a number of years but always put it down to the pressures of working in a busy salon.

“I didn’t know much about MS before I was diagnosed (in 2009) so it never really crossed my mind. My symptoms really could have been caused by a number of things so I never really expected MS. At one point I temporarily lost my sight in my left eye. I was a terrifying experience and I just didn’t understand why. I was hospitalised and after a number of tests I was eventually diagnosed.

“To be honest I refused to accept it initially. I just didn’t think it could happen to me. I tried to find another reason for my symptoms. My husband Darren was really supportive and helped me to come to terms with it and learn more about the condition. I’ve found it difficult because many people don’t understand MS. They think because you look well, that you can’t possibly be feeling unwell and that can be frustrating.”

Linda continues: “Every single day I experience pain and fatigue. It is constant and it would be very easy to feel down about it and give up but I have my kids and lovely husband to keep me going. They help me to fight back in my way by staying positive and living my life to the full.

“I regularly attend my local bowling club, Comber Bowling Club and play bowls with my family. My two children play for the international team and I’m so proud of them. The club received a grant to provide a specially adapted wheelchair so I can still enjoy a game with my family. I go two or three times a week and really love it. Staying active helps me to manage my condition.

“There is no cure for MS yet but that’s not an excuse. I have no choice; I just have to keep fighting back”.

Source: News Letter © 2012 Johnston Publishing Ltd (03/05/12)

Neuropathic pain, caused by nerve or tissue damage, is the culprit behind many cases of chronic pain. It can be the result of an accident or caused by a variety of medical conditions and diseases such as tumors, Multiple Sclerosis, and diabetes. Typically resistant to common types of pain management including ibuprofen and even morphine, neuropathic pain can lead to lifelong disability for many sufferers.

Now a drug developed by Tel Aviv University researchers, known as BL-7050, is offering new hope to patients with neuropathic pain. Developed by Prof. Bernard Attali and Dr. Asher Peretz of TAU's Department of Physiology and Pharmacology at the Sackler Faculty of Medicine, the medication inhibits the transmission of pain signals throughout the body. In both in-vitro and in-vivo experiments measuring electrical activity of neurons, the compound has been shown to prevent the hyper-excitability of neurons - protecting not only against neuropathic pain, but epileptic seizures as well.

The medication has been licensed by Ramot, TAU's technology transfer company, for development and commercialisation by BioLineRx, an Israeli biopharmaceutical development company.

Targeting potassium for pain control

According to Prof. Attali, the medication works by targeting a group of proteins which act as a channel for potassium. Potassium has a crucial role in the excitability of cells, specifically those in the nervous system and the heart. When potassium channels don't function properly, cells are prone to hyper-excitability, leading to neurological and cardiovascular disorders such as epilepsy and arrhythmias. These are also the channels that convey pain signals caused by nerve or tissue damage, known as neuropathic pain.

With few treatment options available for neuropathic pain, Prof. Attali set out to develop a medication that could bind to and stabilize the body's potassium channels, controlling their hyper-excitability and preventing the occurrence of pain by keeping the channels open for the outflow of potassium. This novel targeting approach has been recently reported in the journal PNAS.

Inducing calm in the neurons

Understanding the mechanism that controls these channels has been crucial to the development of the drug. By successfully controlling the excitability of the neurons, Prof. Attali believes that BL-7050 could bring relief to hundreds of millions of patients around the world who suffer from neuropathic pain. The medication will reach the first phase of clinical trials in the near future.

In pre-clinical trials, BL-7050 was tested in rats experiencing both epilepsy and neuropathic pain and was found to be efficient in protecting against both when taken as a pill. While on the medication, rats were no longer affected by stimuli that had previously caused pain. Measures in the electrical activities of neurons also revealed that the medication was able to induce "calm" in the neurons, inhibiting pain pathways.

Source: Medical News Today MediLexicon International Ltd © 2004-2012 (03/05/12)

Bone marrow mesenchymal stem cells (BMMSCs) activate a mechanism involving coupling of FAS/FAS ligand to induce T cell apoptosis and immune tolerance, according to an experimental study published online April 26 in Cell Stem Cell.

To investigate the mechanisms underlying the therapeutic benefit of BMMSCs in autoimmune disease, Kentaro Akiyama, D.D.S., Ph.D., from the University of Southern California in Los Angeles, and colleagues infused BMMSCs into mice.

The researchers found that, in mice models of systemic sclerosis or experimental colitis, infusion of BMMSCs induced T cell apoptosis via the FAS ligand-dependent FAS pathway, and reduced symptoms of the disease. This was not seen in BMMSCs not expressing the FAS ligand. The apoptotic T cells triggered macrophages to produce transforming growth factor-β which upregulated CD4+CD25+Foxp3+ regulatory T cells leading to immune tolerance. In five patients with systemic sclerosis who received a transplant of allogenic mesenchymal stem cells, disease symptoms improved and the FAS pathway was involved.

"These data therefore demonstrate a previously unrecognized mechanism underlying BMMSC-based immunotherapy involving coupling via FAS/FAS ligand to induce T cell apoptosis," Akiyama and colleagues conclude.

Abstract

Source: Doctors Lounge Copyright © 2001-2012 Doctors Lounge (03/05/12)

Accidental fetal exposure to natalizumab did not appear associated with shorter mean birth length, lower mean birth weight, or lower mean gestational age in pregnant multiple sclerosis patients, according to small studies presented here.

Based on data from an MS and pregnancy registry in Germany, seven babies born to MS patients were exposed to natalizumab (Tysabri) during the third trimester and two were found to have profound anemia at birth, but both recovered and all the infants in the group are now healthy, said Kerstin Hellwig, MD, from St. Josef Hospital/Ruhr University in Bochum, at the annual meeting of the American Academy of Neurology.

Women with MS are often advised to discontinue disease-modifying drugs prior to conceiving -- Hellwig noted that current recommendations call for suspension of natalizumab therapy 3 months prior to a planned pregnancy -- but accidental exposure still occurs.

In the national registry, Hellwig said 62 pregnancies were recorded in which exposure to natalizumab occurred at some time point during gestation. Of those babies, 48 babies were born healthy. One boy was born with an extra digit that was successfully amputated at age 1. There were eleven spontaneous miscarriages that occurred, there was one tubal pregnancy, and one women who electively terminated the pregnancy.

"From our study it appears that accidental exposure to natalizumab in the first trimester does not appear to cause major risk to the children," she said. "There might be some minor risks but we cannot observe them at the present because we have small numbers of patients."

In a second study, Ellen Lu, a PhD candidate at the University of British Columbia in Vancouver, and colleagues conducted a literature review through August 2011 and found 15 studies that identified 761 interferon-beta, 97 glatiramer acetate (Copaxone), and 35 natalizumab exposed pregnancies.

They reported that compared with unexposed pregnancies, fair to good quality prospective cohort studies reported that interferon-beta exposure was associated with lower mean birth weight, shorter mean birth length, and preterm birth, but not low birth weight, cesarean delivery, congenital anomaly, or spontaneous abortion.

While there were fewer studies of fair quality available for glatiramer acetate and natalizumab, neither drug was associated with lower mean birth weight, congenital anomaly, preterm birth or spontaneous abortion.

However, they cautioned that the quality of all the studies ranged from poor to good and most studies were limited by small sample sizes. Also, few studies examined long-term developmental outcomes in children who were exposed in utero.

Lu said the jury is still out on recommendations for newer agents such as fingolimod (Gilenya). "There is no clear signal of harm with these newer drugs," she said. "If women are exposed to these drugs, we don't think we should recommend that they terminate their pregnancy, but they should try to come off the drug."

Hellwig stressed the importance of counseling female MS patients about the possible consequences of MS drugs. In her study, 40% of the women experienced MS relapse while off natalizumab during pregnancy. "There does appear to be a protective effect of pregnancy on MS patients, but that protective effect is not complete," she explained.

She pointed out that if severe MS activity occurs during the pregnancy, and the mother takes natalizumab during the last trimester, the babies require close watch after birth. "I would continually monitor the mother, and would closely follow the children for 2 years," she said.

She said that additional safety data of natalizumab exposure during pregnancy are needed to exclude any major teratogenic or pro-abortive risks.

Hellwig disclosed commercial interests with Bayer Pharamceuticals, Schering AG, Biogen Idec, Merck Serono, Teva Neuroscience, Aventis Phramceuticals Corporation, Novartis, and Serono.

The German MS and pregnancy registry was partly supported by Bayer Healthcare, Biogen Idec Germany, Merck Serono, Teva Sanofi Aventis, and Novartis.

Primary source: American Academy of Neurology

Source reference:
Lu E, et al. "Disease-Modifying Drugs for Multiple Sclerosis in Pregnancy: A Systematic Review" AAN 2012;abstract P06.188.
Additional source: American Academy of Neurology
Source reference:
Hellwig K, et al. "Natalizumab and Pregnancy – Results from the German MS and Pregnancy Registry" AAN 2012;abstract P06.187.

Source: MedPage Today © 2012 Everyday Health, Inc (02/05/12)

Researchers studying multiple sclerosis(MS) have long been looking for the specific molecules in the body that cause lesions in myelin, the fatty, insulating cells that sheathe the nerves. Nearly a decade ago, a group at Mayo Clinic found a new enzyme, called Kallikrein 6, that is present in abundance in MS lesions and blood samples and is associated with inflammation and demyelination in other neurodegenerative diseases.

In a study published this month in Brain Pathology, the same group found that an antibody that neutralizes Kallikrein 6 is capable of staving off MS in mice.

"We were able to slow the course of disease through early chronic stages, both in the brain and spinal cord," says lead author Isobel Scarisbrick, Ph.D.,of the Mayo Clinic Department of Physical Medicine and Rehabilitation.

Researchers looked at mice representing a viral model of MS. The model is based on the theory that infection with viral infection early in life results in an eventual abnormal immune response in the brain and spinal cord. One week after being infected with a virus, the mice showed elevated levels of Kallikrein 6 enzyme in the brain and spinal cord. However, when researchers treated mice to produce an antibody capable of blocking and neutralizing the enzyme, they saw a decrease in diseases effecting the brain and spinal cord, including demyelination. The Kallikrein 6 neutralizing antibody had reduced inflammatory white blood cells and slowed the depletion of myelin basic protein, a key component of the myelin sheath.

The findings in the MS model have implications for other conditions affecting the brain and spinal cord. The group has previously shown that the Kallikrein 6 enzyme, produced by immune cells, is elevated in spinal cord injury, while other studies have shown it to be elevated in animal models of stroke and patients with post-polio syndrome.

"These findings suggest Kallikrein 6 plays a role in the inflammatory and demyelinating processes that accompany many types of neurological conditions," says Dr. Scarisbrick. "In the early chronic stages of some neurological diseases, Kallikrein 6 may represent a good molecule to target with drugs capable of neutralizing its effects."

Source: Medical Xpress © Medical Xpress 2011-2012 (01/05/12)

Randomised controlled trials of multiple sclerosis drugs have consistently improved since the first positive result in 1993, but more transparent methodology is required as trials enter a “new era”, experts argue.

After analysing the methodology of 53 eligible RCTs that took place in the eighteen years up to 2010, the Italian trio note a steady rise in quality – mainly down to “many journals having statistical refereeing and clearer guidelines to authors.”

But with the clinical scenario in MS changing “rapidly” as trials become increasingly benign, certain questionable practices need closer scrutiny, the authors say.

“The advent of new therapies has made the use of placebo unethical, at least in trials lasting more than six months,” they write in Multiple Sclerosis Journal.

Despite general improvements there also remain problems with the use of significance tests for detecting baseline differences.

Occurring in about half of the trials analysed, the authors argue its use is null since randomisation guarantees that any baseline differences are due to chance.

A more significant practice would be to provide information on whether baseline factors are associated with outcome. This, however, is rare.

As well, there are enduring problems with subgroup analysis.

Interaction tests, used to assess the heterogeneity of treatment effect across different subgroups, are the “correct approach” but remain underused.

Smaller trials are often underpowered to use such tests effectively, say the authors, who argue for companies to work together and pool collective analyses – something they habitually avoid out of a reluctance to share information.

It is up to journals, so instrumental in boosting methodological quality to date, to encourage pooled analysis, they conclude.

Multiple Sclerosis Journal, 2012; doi:10.1177/1352458512444327

Source: Neurology Update (01/05/12)

Scientists claim to have discovered that the progress of debilitating disease multiple sclerosis could be slowed or even stopped by blocking a protein which contributes to nerve damage.

An international team has shown that the key role played by the collapsing response mediator protein 2 (CRMP-2)) in the development of multiple sclerosis (MS), the `Brain` journal reported.

In their research, the scientists found that a modified version of CRMP-2 is present in active MS lesions, which indicate damage to the nervous system, in a laboratory model of MS.

The modified CRMP-2 interacts with another protein to cause nerve fibre damage that can result in numbness, blindness, difficulties with speech and motor skills, and cognitive impairments in sufferers.

When either the modified CRMP-2 or the interaction between the two proteins was blocked, using a method already approved in both the US and Australia, the progression of the disease was halted.

The scientists say that the discovery could lead to new treatments for MS.

"Blocking the same protein in people with MS could provide a `handbrake` to the progression of the disease," Prof Richard Boyd of Monash University, a team member, said.

Dr Steven Petratos, the team leader, said the method used to block the protein was approved for the treatment of other disease conditions by both the US Food and Drug Administration and Australia's Therapeutic Goods Administration.

"This should mean that clinical trials -- once they start -- will be fast tracked as the form of administration has already been approved," he added.

Source: ZeeNews.com © 1998-2012 Zee News Limited (30/04/12)

The Helen Ley care centre near Leamington has finally been saved from closure, now that neighbouring care home Castel Froma has signed a take-over deal.

The move comes two years after former owner, the national charity the MS Society, announced it would have to close the centre - which provides respite care for people with multiple sclerosis - unless a new owner was found. The uncertainty over whether this would happen prompted all of Helen Ley’s permanent residents to find homes elsewhere.

Castel Froma, a specialist neuro-disability rehabilitation based in Lillington Road, has now confirmed that it has taken over the 34-bed home.

Robert Pearce, chief executive of the centre, which already cares for patients of multiple sclerosis, as well as other neurological conditions, said that, having worked tirelessly to keep Helen Ley operating, it was now “open for business”.

He said: “The centre is now available for both long-term stay and respite support.

“Helen Ley will continue to be a dedicated centre for those with MS, and in future we might consider offering the facility to people with other neurological conditions in response to local demand.

“Our main focus now is to place the centre on a sound financial footing and to ensure that it remains in the heart of the community for years to come. We owe it to the public to keep it going.”

The MS Society made the decision to end its respite care service in 2010 and was unable to find an alternative provider to buy it until negotiations began with Castel Froma at the end of last year.

Source: The Courier © 2012 Johnston Publishing Ltd. (30/04/12)

If you had told 30-year-old George Pepper, from Leeds, a few years ago that he would travel round the world, he wouldn't have believed you.

That his girlfriend would accompany him and return as his fiancée, was a little less of a surprise - for him at least.

"We were in Florianopolis in Brazil. I'd got the ring beforehand, there was a really nice beach...," he says, voice tailing off as he recalls the romantic proposal.

George's trip was particularly special because he was diagnosed with multiple sclerosis when he was 22.

Getting used to his diagnosis was difficult and the uncertainty of how the condition would progress was frightening.

In the first two years, he had seven relapses. He experienced blurred vision, difficulty walking, vomiting, extreme fatigue and a lack of feeling on his left side.

George has Relapsing Remitting MS, which meant that the symptoms only lasted a number of weeks at a time, but he did have to stop working for several months.

"But I'd always wanted to go travelling. The more I heard about it, the more I wanted to do it," George says.

"I'm quite stubborn. I didn't want to look back and regret anything."

Months of careful planning and years of saving funds followed.

"My trip was incredible. I feel very lucky. I look back and think 'what an experience'.”

'Alone'

In the meantime he founded a website, shift.ms, for young people with the neurological condition, because he felt alone and isolated in those early days.

A grant from the Wellcome Trust to improve communication between MS researchers and young MS sufferers followed.

As a result, a busy online forum and a real community of friends has now built up around the website, which has become a valuable support network for young people.

Before George set off on his world tour he had another relapse, losing his hearing in one ear for eight weeks. He also had co-ordination issues, kept losing his balance and felt extremely tired.

At the same time it was suggested that he change his treatment from daily drug injections to monthly intravenous infusions - a move which dramatically improved his health.

To maintain this treatment schedule, his doctors in Leeds suggested stopping off at hospitals in Melbourne, Australia, and Sao Paolo, Brazil, to receive the required drugs dose - an arrangement that worked perfectly.

But there were other considerations too.

"I was very nervous about the heat and humidity before we left, a common issue for people with MS.

"So we always planned activities in the early morning or evening - and took lots of drinks breaks.

"And we tried to put in lots of rest days in our itinerary, and paid a bit more for comfier seats on long-distance bus journeys."

'Incredible journey'

After recently returning from his long-awaited six-month journey to places like India, Japan, Indonesia, New Zealand and South America, George is elated by all the things he has done and seen.

"It was incredible. I feel very lucky. I look back and think 'what an experience'."

George is just one of more than 100,000 people in the UK who have MS.

Most are diagnosed between the ages of 20 and 40 and yet a new report from the MS Society found that few young people were aware of this fact.

The report surveyed over 1,400 people with MS, and over 2,000 without MS.

Almost one in three people couldn't name any of the common symptoms of MS, which include problems with balance, vision, fatigue, bladder, bowel, speech, memory and muscle spasms.

Simon Gillespie, chief executive of the MS Society says multiple sclerosis is poorly understood, even by those who know people with MS.

"Because it is poorly understood, living with MS can turn a simple shopping trip or social event into an ordeal where strange looks and hurtful remarks can all be part of everyday life."

Social impact

The survey found that more than half of people with MS find it harder to socialise since their diagnosis, with around two-thirds saying their MS has hampered their ability to enjoy everyday social activities.

Yet people with MS want the same things as everyone else, like a successful career and an active social life.

Before his travels, George worked for a marketing agency in Leeds but he has now decided to concentrate full time on shift.ms, and on helping other people achieve their goals.

"There are plenty of people less fortunate than me. I feel fine now. The side effects from the drugs are minimal and I'm getting married next spring."

His condition didn't stop him enjoying a wonderful trip, partly because MS was way down his list of priorities.

There were slow days and tiring days, he admits, and a bout of tonsillitis in New Zealand, but keeping busy was important.

"MS doesn't mean giving up on your ambitions, it just means rethinking how to achieve them," he says.

Source: BBC News © British Broadcasting Corporation 2012 (30/04/12)