Elan Corporation and Biogen Idec have submitted a priority review application to the U.S. Food and Drug Administration (FDA) for Tysabri (natalizumab) to be made available again for the treatment of MS.

Included in their submission is final two-year data from trials of the drug as a monotherapy, and in combination with the beta interferon Avonex, a safety assessment, and a plan for monitoring risk.

If priority is granted, the FDA will make its decision in approximately six months. The companies will then submit similar data to the European Medicines Agency (EMEA).

In February, Biogen Idec and Elan voluntarily suspended Tysabri from the U.S. market, along with all ongoing clinical trials, based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system.

"I suspect that a priority review will be granted," commented Ben Thrower, M.D., MSF Medical Advisor and Medical Director of the MS Center at Shepherd in Atlanta. "Should Tysabri become available again, I would use it in very select cases, such as in those that have failed treatment with the ABCR drugs. I would not consider it as a first line drug at this time. As we gain more information on monitoring for potential PML, our comfort level with using the drug could increase."

MSFocus, the national magazine of the Multiple Sclerosis Foundation (MSF) is now available on CD for individuals with impaired vision and other disabilities associated with MS.

This new audio version of the MSF's quarterly publication allows everyone with MS the opportunity to benefit from the upbeat, informative articles, many of which are written by neurologists, researchers, and other healthcare professionals from leading MS centers around the world. Articles address traditional and alternative healthcare, cutting edge treatments, research, symptom management, quality of life, gender-specific issues, and more.

"I have been legally blind for 15 years and unable to read on my own," said Cheryl Chatman, who was diagnosed with MS at the age of 25. "My husband has always had to read MSFocus to me. Now that it's on CD, I have regained some of my independence."

Students from the Connecticut School of Broadcasting (CSB) in Davie, Florida, produced and edited the CD under the guidance of Director and Lead Radio Instructor, Christopher Hudspeth, and CSB graduate student, Dayana Pintaluga.

"This project is extremely beneficial to the students at CSB because it allows them to practice their skills in a long form application," Hudspeth said. "At the same time, it teaches them the value and joy of giving back to the community. As an added bonus, they are learning about a chronic incurable illness that affects between 350,000 to 500,000 thousand people in the

U.S."

To obtain an audio subscription to MSFocus, call the MSF's Program Services Department at 888-MSFOCUS (673-6287)

ONCE-DAILY ORAL MED MAINTAINS PROMISE IN PHASE II

Data from the extension of a phase II study to 12 months maintains that FTY720, a new, investigational oral medication for the treatment of MS, reduced the rate of clinical relapses by more than 50% and inflammatory disease activity as measured by magnetic resonance imaging (MRI) by up to 80% during six months compared to placebo. This low relapse rate was maintained during the subsequent 6-month extension. This data, presented at the ECTRIMS/ACTRIMS* meeting in Thessalonica, Greece, lends further confirmation to previous findings.

Based on the positive phase II study results, Novartis Pharmaceuticals Corporation, manufacturers of the drug, are currently discussing the Phase III program with regulatory authorities. Phase III is expected to begin by the end of 2005.

FTY720, which has a mode of action that is different from all available therapies, binds to the surface of certain white blood cells in a way that keeps them from sites of inflammation and causing additional damage.

There were no unexpected safety findings during the extension as compared to the six-month placebo controlled phase. The most frequently reported adverse events in patients treated up to twelve months were colds, influenza, headache, diarrhea, and nausea.

(*21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).)

It's time to honor that special caregiver! Surprise them with some time off by finding someone to take over their duties for a day, or arrange a schedule to rotate responsibilities between several family members or friends. Visit http://www.caregiver.com and sign them up for an informative, weekly e-newsletter, packed with a wide variety of articles for caregivers. It doesn't matter if you bake them cookies, let them sleep late, send them an e-card, or take them out to dinner. Just make sure you do something to pamper the compassionate caregiver in your life.

CANNABIS-BASED MEDICINE EASES CENTRAL PAIN IN MS

Central pain in MS is common, affecting somewhere between 55-65 percent of those living with the disease. Unfortunately, this type of pain is often resistant to treatment.

In the U.K., researchers from the Walton Centre for Neurology and Neurosurgury conducted a single-center, five-week, randomized, double-blind, placebo-controlled, parallel-group trial in 66 patients with MS and central pain (fifty-nine experienced feelings of numbness, tingling, prickling, or burning, and seven experienced painful spasms) and a whole-plant cannabis-based medicine (CBM) delivered via an oral spray. Patients could gradually increase the dosage to a maximum of 48 sprays in 24 hours.

Sixty-four patients completed the trial. Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale. CBM was superior to placebo in reducing the intensity of pain and sleep disturbance. CBM was generally well tolerated, although more patients on CBM than placebo reported dizziness, dry mouth, prolonged drowsiness. Cognitive side effects were limited to long-term memory storage.

The researchers concluded that cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with MS-related central neuropathic pain and is mostly well tolerated.

This year, why not send holiday greeting cards and support the programs and services of the MSF at the same time?

Jennifer Bonini of Tinley Park, Illinois is at it again! Her MS Awareness Magnets were so successful, that she's now created a new website for MS Holiday Cards. Cards come in boxes of twelve with six holiday designs.

"I have received so many letters from people about my MS Awareness Magnets," Jennifer says. "I thought I'd give this a try. It's a great feeling when you can make someone else smile."

The price of twelve cards is $15. Price includes shipping and handling. Payment is accepted online with a credit card or by sending a check or money order via postal mail. To learn more, visit

http://www.msholidaycards.com.

In response to a Food and Drug Administration's advisory asking patients, family members, and clinicians to monitor antidepressant treatment, Families for Depression Awareness has created the Depression Monitoring Kit.

Designed for adults diagnosed with major depression or dysthymia (a chronic, mild form of depression that has been present for at least two years) the Depression Monitoring Kit is an educational booklet to help adults with depression (and their family members) monitor depression treatment with daily and weekly tools.

It is believed that the kit works best when used with a family member or friend because research has shown that working with others helps people with depression get better sooner and stay well. However, the kit can be used alone as well, either by the patient or their friend or family member.

"Whether the patient is on medication, engaged in talk therapy, or both, this kit is the first of its kind to help both patients and families to work together to monitor treatment and get well," said Julie Totten, President and Founder of Families for Depression Awareness. "This kit will also help people to recognize what works for them and what doesn't, and to focus on getting well rather than struggling with treatment that may not be working for various reasons."

If you would like to participate or simply learn more, call 781-890-0220 or send an email to info@familyaware.org. To learn more about Families for Depression Awareness, visit http://www.familyaware.org

The arts are a creative path to self-expression, communication, and independence. They allow us to experience the delight of discovery and exploration, and the value of one another's ideas. VSA arts, an international organization founded in 1974, is dedicated to providing opportunities for people with disabilities to participate in the visual, performing, and literary arts.

Each year, VSA arts sponsors juried exhibitions, performances, and festivals across the U.S. and in 60 countries worldwide. For aspiring artists, these events provide exposure, recognition, and monetary awards that can be invaluable to their careers.

Working at the state, national, and international level, VSA arts reaches out to all artists and encourages them to sign up for their Artist Registry. More than 1,200 visual, literary, and performance artists are already members of the registry, an online database that is connected to the VSA arts site. A quarterly magazine is also available, full of information on upcoming events, and Internet resources for the disabled community in the arts.

VSA arts is an affiliate of the John F. Kennedy Center for the Performing Arts. Registration is free. Visit www.vsarts.org to see what's happening in your area.

A special thank you to mosaic artist Patsy Rodriguez for assistance with this article. Wife, mother, and mosaics teacher, Patsy has had MS for 18 years. To learn more about VSA arts, email her at PRODRIG95@AOL.com. Please type "from MSF" in the memo line.

Studies have shown that many mothers in the general population have not yet fully resumed their usual level of activities of daily living (ADL) at six months postpartum. Among mothers with MS, ADL functioning may be further compromised as a result of MS relapse. Identification of specific areas of ADL functioning deficits among mothers with MS over the postpartum year can provide caretakers and health providers with information so that appropriate interventions may be sought.

Consequently, a longitudinal study was conducted to compare ADL functioning of mothers with MS who experienced a relapse with those who did not at three-month intervals throughout the first postpartum year.

Across North American, pregnant women with MS, or those who had recently given birth, were recruited. The women completed the five-item ADL scale for persons with MS at 1, 3, 6, 9, and 12 months following the birth of their baby or babies, along with a health questionnaire that included the experience of confirmed MS relapse. Independent tests were used to determine if differences existed between mothers who experienced relapse with those who were relapse-free. Testing was conducted in two areas of ADL functioning, Personal Care & Communication, and Intimacy & Socializing.

As expected, increased deficits in ADL functioning occurred in the relapse compared to the non-relapse group mostly during the birth to 3 and the 10-12 postpartum months. Significantly poorer Personal Care & Communication functions included: 'getting in and out of the tub or shower,' 'turning from side to side while lying,' 'working buttons/zippers/ laces,' 'walking inside the house,' 'getting to and from their present method of travel,' 'using a telephone,' and 'reading printed material.'

Significantly poorer Intimacy & Socializing functions included 'participating in social and recreational activities,' and 'confiding in someone.'

Mothers with MS are vulnerable to relapse and continuing or re-occurring ADL functional deficits during the year following the birth of their baby/babies. Consideration must be given to possible ways that may prevent relapse and promote a higher level of ADL functioning.

"Increased communication of needs, and willingness to ask for help, as well as learning how to pace yourself is essential," states Traci Seidman, Ph.D. "New mothers must avoid the need to have everything under control at all times. If help is available or offered, say yes! Don't feel compelled to be in charge of everything. All the little things add up in a day, and can lead to exhaustion. When the baby is napping, Mommy needs to be napping, too - not folding laundry or cleaning baby bottles. Remember to eat a healthy diet and get plenty of rest."

(International Journal of MS Care, Summer 2005)

BEE STING THERAPY SHOWS NO BENEFIT FOR MS

Bee sting therapy or apitherapy is sometimes used to treat individuals with MS and other health problems. Advocates claim that the bee sting produces inflammation and that the body naturally produces an anti-inflammatory response. However, previous studies in the animal model of MS indicate that bee sting therapy is not effective or may actually be harmful.

In a randomized, crossover* study, researchers from the Netherlands assigned 26 patients with relapsing-remitting or relapsing secondary progressive MS to 24 weeks of medically supervised bee sting therapy or 24 weeks of no treatment. Live bees (up to a maximum of 20) were used to administer bee venom three times per week.

During bee sting therapy, there was no significant reduction in the cumulative number of new gadolinium-enhancing lesions. The T2-weighted lesion load further progressed, and there was no significant reduction in relapse rate. There was no improvement of disability, fatigue, and quality of life. Bee sting therapy was well tolerated, and there were no serious adverse events.

In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity, disability, or fatigue and did not improve quality of life.

* In a "crossover study," one group starts on placebo and one group on active treatment. At the halfway point, the two groups are switched.

From the Department of Neurology, University Medical Center Groningen, Groningen (Drs. Wesselius, Heersema, Mostert, De Keyser, M. Heerings), Department of Radiology, Gemini Hospital, Den Helder (Dr. Wesselius), Department of Radiology, Leiden University Medical Center, Leiden (Drs. Admiraal-Behloul, Talebian, and van Buchem), The Netherlands

PMID: 16221950 [PubMed - as supplied by publisher]

If you enjoy the music of Ricky Scaggs, Alison Krauss, Charlie Daniels, Dottie Rambo, Sonya Isaacs, Russ Taff, and others, then we've got a great way for you to help others with MS and get the inspirational music you love!

Over 20 legendary country/gospel performers gathered to record an inspirational CD/DVD combo called Roger Neal & Friends Sing for MS: The Lord Will Provide.

Proceeds benefit the Multiple Sclerosis Foundation, the Multiple Sclerosis Society, and the MS Kids Connection.

When Lynn Neal, wife of Southern Gospel artist Roger Neal, was diagnosed with MS last year, the couple longed to help others with more progressive forms of the disease.

The CD/DVD combo, priced at $19.95, is now available - just in time for holiday gift giving! To get your copy of Roger Neal & Friends Sing for MS: The Lord Will Provide, visit www.wheregodguides.com. Or call toll-free, 1-877-450-9697.

Editor's Note: The MSF is a secular organization and appreciates the support and involvement of all faiths.

Are you a friend, family member, care partner, spouse, or significant other of someone living with MS or struggling through the diagnostic process? Visit our new MSFamilies forum and talk to others facing similar challenges. Ask questions of those who have been where you are, offer support to those in need, meet new friends, or just vent among peers who understand where you're coming from.

Log onto our website at http://www.msfocus.org. Click on "forums" on the left-hand side of the home page and then click on MSFamilies. We need you to help make MSFamilies the supportive network we envision for the MS community. So, don't be shy - log on and say hi!.