Multiple Sclerosis Newsletter
Northern Colorado Edition

August - September 2005

Research Updates

TWO NEW ORAL DRUGS SHOW POSITIVE RESULTS IN PRELIMINARY TRIALS IN M.S.
Nat. M.S. Soc. (June 21, 2005)

Summary: Two different experimental oral therapies for multiple sclerosis have shown positive results in preliminary Phase 2 clinical trials, according to researchers reporting at this week’s European Neurological Society meeting in Vienna. The results, reported by Dr. Ludwig Kappos (University Hospital, Basal, Switzerland) and colleagues, suggest that FTY720 (Novartis Pharmaceuticals Corp) and temsirolimus (Wyeth Pharmaceuticals) warrant further clinical study.

“These are exciting preliminary findings for experimental oral therapies for MS,” said John R. Richert, MD, Vice President of Research and Clinical Programs at the National Multiple Sclerosis Society. “We hope that these drugs live up to their early promise when tested in longer-term studies,” he continued.

Generally drug approval agencies require results from at least one larger, longer Phase 3 trials before they will consider approving an experimental agent. There are currently five disease-modifying agents approved for MS, and all of them are given by injection or infusion.

Details: At this week’s European Neurological Society meeting in Vienna, Dr. Ludwig Kappos (University Hospital, Basel, Switzerland) and colleagues reported results from preliminary Phase 2 controlled clinical trials from two potentially promising oral therapies for MS: FTY720 (Novartis Pharmaceuticals Corp) and temsirolimus (Wyeth Pharmaceuticals).

FTY720: This drug binds to a docking site (sphingosine-1-phosphate receptor) on immune cells, including T cells and B cells that have been implicated in causing nervous system damage in MS, and induces them to remain in lymph nodes, where they can do little harm.

The investigators conducted an international, double-blind, placebo-controlled study involving 281 participants with active relapsing MS. Participants received one of two doses of oral FTY702 or placebo daily for 6 months. The primary outcome studied was the number of enhancing lesions (spots on brain MRIs showing active inflammation) evident on monthly MRI scans. After 6 months, the total number of enhancing lesison was significantly reduced in both groups receiving treatment, versus those on placebo. Similar results favoring the treatment groups were seen for volumes of enhancing lesions and new non-enhancing lesions. There were more people in the treatment group (86%) versus placebo group (70%) who stayed relapse-free during the 6 months of the trial. Both treatment groups experienced a reduction of relapse rates ranging from 53% to 55% compared to those on placebo. The most frequently reported side effects were mild headaches, colds, and gastrointestinal disorders such as nausea and diarrhea. These promising findings from this short-term study suggest that further clinical testing of this oral drug for MS is warranted. According to a Novartis press release, the company is discussing with regulatory authorities a Phase 3 study of FTY720 which they hope to launch by the second half of 2005.

Temsirolimus: This drug blocks the proliferation of immune T cells activated by the immune messenger protein called interleukein 2. Such T cells are thought to play a role in the immune attack against the nervous system that underlies MS. The investigators conducted an international double-blind, placebo-controlled clinical trial involving 296 individuals with relapsing-remitting MS or secondary progressive MS with relapses. The participants received one of three doses of oral temsirolimus or placebo daily for 9 months. The primary outcome studied was the cumulative number of new enhancing MRI lesions at 9 months. By 32 weeks into the study, participants on the highest dose had accumulated significantly (47.8%) fewer new enhancing lesions compared to those on placebo. The high-dose group also experienced 51% fewer relapses than the placebo group. Side effects reported more often in the high-dose group versus those on placebo included mouth ulcerations or inflammation, menstrual dysfunction, increased blood lipids (hyperlipidemia) and rashes. These promising findings from this short-term study suggest that further clinical testing of this oral drug for MS is warranted. At this time, Wyeth has not made public any plans for further Phase 3 testing.

RELAXATION AND HEALTH-RELATED QUALITY OF LIFE IN MULTIPLE SCLEROSIS: THE EXAMPLE OF AUTOGENIC TRAINING
Sutherland G, Andersen MB, Morris T
J Behav Med. 2005 Jun,28(3):249-5

This study was a pilot project to explore the effect of an autogenic training program (AT: a relaxation intervention) on the health-related quality of life (HRQOL) and well-being for people with multiple sclerosis. Participants either met weekly for sessions in AT for 10 weeks (n=11) or were assigned to the control group (n=11). The AT group was also asked to practice the technique daily at home. Scales designed to measure HRQOL and aspects of well-being (mood and depressed affect) were taken preintervention and at week 8 of the 10-week program. ANCOVAs using a measure of social support and pretest scores as covariates revealed that at the posttest the AT group reported more energy and vigor than the control group and were less limited in their roles due to physical and emotional problems. Further research should involve studies conducted over an extended period, together with sufficiently sized samples to explore the effect of frequency of practice of relaxation training on HRQOL and well-being for people with multiple sclerosis.

NEW MEDICARE Rx BENEFIT FAST APPROACHING: THIS SUMMER – APPLY FOR FINANCIAL ASSISTANCE
Nat. M.S. SOC. 2005 Spring

The biggest change to public health insurance in forty years, the Medical Prescription Drug Benefit (Part D of Medicare) begins January 1, 2006. This summer, the focus is on ensuring that people with limited incomes qualify to receive the financial assistance which will be available with the drug benefit. This extra help may mean you don’t have to pay a monthly premium or yearly deductible (which on average will be $37/month and a $250 deductible) and your co-payments for your prescriptions will be low. The help is available on a sliding scale, so if your income is higher and near the qualifying limit, you may have to pay a little more.

Some people will automatically qualify for the extra help and do not need to apply. If you have both Medicaid with prescription drug coverage and Medicare, or if you have Medicare and Supplemental Security Income, or if the state pays for your Medicare premiums, then you automatically will get this extra help. You do not need to apply.

If your annual income is below $14,355 for an individual or below $19,245 for a married couple, you likely will qualify for some financial help. Even if your income is a bit higher, you may still qualify based on your special circumstances. Your resources will also be taken into account and will generally be limited to $10,000 for an individual and $20,000 for a married couple. Your home and car do not count as resources and your resource limits may be higher under certain circumstances. Please consider applying if you fall within these limits, or even if you are slightly above because you still may qualify for some assistance.

Applications for the low-income subsidies, or financial assistance, are being processed this summer by the Social Security Administration (SSA). You may have already received an application and related information in the mail. SSA is mailing millions of applications to people it thinks will qualify for the financial assistance. However, anyone can apply. If you think you meet the criteria, even if you did not receive an application for SSA, you should apply for the subsidies.

Applications are available on line at:
www.socialsecurity.gov/prescriptionhelp or you can call SSA at 1-800-772-1213 for an application or for help with filling out the application. The application form is called Application for Help with Medicare Prescription Drug Plan Costs, also referred to as Form SSA-1020.

For continually updated information on the Medicare Prescription Drug Benefit, you can visit the National MS Society's website at www.nationalmssociety.org. Please call 1-800-FIGHT-MS to address any problems you face applying for the low-income subsidies or with the Medicare drug benefit.

Timeline for Medicare Rx Benefit
May 2005-August 2005: Apply for low-income subsidies at www.socialsecurity.gov.

Fall 2005: Current Rx coverage through former employers, unions, or other sources, will notify you if it is equal to coverage under the Medicare Rx benefit.

Early October 2005: Medicare beneficiaries receive Medicare and You for 2006 handbook in the mail; Prescription drug plans begin marketing.

Mid October 2005: Tools available to compare plans at 1-800-MEDICARE and www.medicare.gov.

November 15, 2005: Enrollment drug plan begins.

November 15, 2005- May 15, 2006. Open enrollment period.

January 1, 2006: Prescription drug benefit begins.

View a more detailed timetable.

General Information about the Medicare Rx Benefit

The Medicare Tax benefit (Part D) will be available to all Medicare beneficiaries. However, if you have other prescription drug coverage that is equivalent to or better than the coverage available under the Medicare drug benefit, then you may keep your current Rx coverage. You will be notified this fall as to whether your current cover rate is equivalent (also called creditable coverage).

For people on Medicare without current Rx coverage or for those who want the new drug benefit, the fall will be a busy time for you. To enroll in the drug benefit, you will need to choose from a number of private prescription drug plans in your area which have been approved by Medicare. These plans will become known to the public in October, allowing you to compare plans to decide which is right for you. You need to enroll in a prescription drug plan between November 15, 2005 and May 15, 2006. If you do not enroll by May 15, 2006 and you do not have prescription drug coverage that is equivalent to this benefit, when you do enroll you will have a penalty of 1% per month of delay added on to your monthly premium. For those who enroll by the end of 2005, your drug coverage takes effect on January 1, 2006. Those who enroll after January 1, 2006 will have their coverage begin on the first day of the next month.

BEATING THE HEAT
MS Lifelines Newsletter, July Issue

According to some studies, most people with MS are overly sensitive to heat. Even mild overheating may cause a temporary worsening of existing symptoms or the reappearance of symptoms experienced in the past. The most common symptoms related to heat included blurred vision, muscle weakness, and fatigue. MSLifeLines Ambassador Sarah experiences fatigue, weakness, and sometimes loss of balance when she becomes overheated. “Since I know the heat is causing the symptoms, I know how to handle, it,” she says. “I try to stay in air conditioning, drink a lot of water, or use an ice pack to cool off,” says Sarah. Maureen, who lives in Little Rock, AR, says “the humidity is very high where I live. I often limp and feel tired.”

These temporary symptoms may be caused by a slight rise in the body’s core temperature (as little as 0.25 degrees F), because damaged nerves function less efficiently at higher temperatures. In fact, heat tends to make everyone’s nerves work less effectively. This is why applying heat to an injury can help relieve the pain. Raising the temperature of the injured area reduces the ability of these nerve fibers to send their messages. When a person has MS, the movement of nerve impulses is already impaired. Therefore, the heat’s effect on the central nervous system may be more pronounced in someone with MS compared to someone without MS.

There are three things to keep in mind with regard to heat and its effects on people with MS:
* Symptoms caused by heat may be temporary and may not necessarily signal an attack or exacerbation
* Heat exposure does not cause further nerve damage
* Symptoms caused by heat tend to go away once you cool down (usually in half an hour)

But while heat symptoms shouldn’t worry you, it is important to take extra care when they occur. Be sure to talk with your doctor if these symptoms persist longer than an hour.

Three ways to keep your cool. When it comes to coping with the heat, there are three general approaches MS specialists recommend:
* Adapting your lifestyle to avoid very hot situations.
* Maintaining hydration so the body can regulate temperature.
* Using external mechanisms for cooling.

Adapting your lifestyle – This can be as simple as avoiding outdoor activities during the hottest hours of the day. Try and schedule your outdoor activities before 10 am or after 4 pm. And stay out of the direct sun. "I try to go on runs in the morning," Patrick says, "because the heat effects my vision and balance." If you must be in the sun, bring an umbrella to provide your own portable shade, and wear a wide-brimmed, well ventilated hat. Swimming is a great activity for keeping cool if you have to be outside. And it might be a good replacement for other activities you enjoy - such as walking and biking - that you just don't tolerate as well in the heat.

Perhaps the most obvious change you can make during the hottest hours of the day is allowing yourself an air-conditioned "siesta". "I try to schedule a nap on hot days," Sarah says. Have a leisurely lunch. Or go to the movies! In the summertime most theaters are air conditioned to a satisfying chill. "Lots of museum visits are on the agenda during the hot months," Joe admits. You can also read a book like "One Particular Harbor: The Inspiring True Adventures of One Woman with Multiple Sclerosis by Janet Lee James.

Maintaining hydration - It is extremely important to drink fluids when it's hot because the body loses fluid through perspiration and evaporation. Carry a bottle of water with you all the time and drink from it regularly. "I strap a water bottle to my belt so I always have it," Joe says. Some doctors advise people to drink fluids with some sodium in them, such as a sports drink. These drinks provide more of what your body needs to cope with heat. "I always keep a bottle of water within my reach," Patrick says. "And eating popsicles works for me. I go through case of popsicles every summer," he admits.

Many patients make the mistake of cutting back on fluids before they go out, to accommodated their bladder But it's much better to deal with bladder issues directly by planning trips to the bathroom or using medications as directed by your doctor, rather than by cutting fluids. Decreasing fluids not only reduces the body's tolerance of heat, it increases the risk of bladder infections, too. Be sure to ask your doctor about maintaining hydration and managing bladder issues, as there may be specific recommendations just for you.

Using external mechanisms for cooling - Even if you reduce your exposure to heat and maintain hydration, there will be times when the heat is unavailable. What then? Many people wear a hat or bandanna soaked in cold water or containing ice chips. "I'll place a cold compress on my neck," Maureen offers Others get relief by maintaining spritzing themselves with a water spray bottle, sucking on ice chips, or putting a wet towel around their neck when they have to be outside in the midday sun. "I freeze fruit so I'll have something that's cold and healthy to eat, Sara says. "And I treat myself to ice cream cones, milk shakes, and smoothies," she adds. If you'd like to learn how to make your own smoothies and shakes, try Summer Smoothies: Over 130 Cool and Refreshing Recipes by Donna Pliner Rodnitzy.

In addition, there are products you can buy that are designed to help everyone stay cool, which are sometimes used by people with MS. These include:

The CoolSport Vest (310-618-1590 or www.coolsport.net) which works with a unique coolant.

Steelevest (1-888-STEELEV or www.steelevest.com), which uses ice packs to cool you.

Personal Cooling System from The Sharper Image (1-800-344-4444 and www.sharperimage.com), a battery-powered device, which is worn around the neck, uses a tiny, quiet motor fan to create evaporative cooling.

While effective for general cooling, it is important to note that these devices are not specifically designed for people with MS, and their mention here does not constitute an endorsement by Serono and Pfizer. Before using any of these products, it's a good idea to consult your doctor.

There is also evidence that "pre-cooling" the body may be an effective way to deal with summer heat and humidity. Some medical researchers studying the most effective cooling methods for people with MS now recommend immersing the legs up to the thighs in tepid or lukewarm water, and then adding cold water until the tub reaches the temperature of a cold swimming pool. This results in something they describe as a "heat sink", as blood circulates through these pre-cooled parts of the body. Patients report having up to four hours of cooling effect after just 20-30 minutes of soaking in this bath.

Ask your doctor for specific suggestions to deal with heat. You may even want to discuss the ideas in this newsletter with your doctor. Together you can decide what will work best for you. You don't have to suffer and you don't have to be a hermit just because you have MS.

Related Facts:
* Chances are that once you reach the point of thirst, you're already dehydrated.
* Watch out for humidity. The evaporation of sweat helps to cool the body, but humidity limits the amount of evaporation.

BOVINE SPONGIFORM ENCEPHALOPATHY, MULTIPLE SCLEROSIS, AND CREUTZFELDT-JAKOB DISEASE ARE PROBABLY AUTOIMMUNE DISEASES EVOKED BY ACINETOBACTER BACTERIA.
Ebringer A., RashidT., Wilson C.
Ann NY Acad Sci. 2005 Jun;1050:417-28.

Bovine spongiform encephalophy (BSE) belongs to a group of conditions named together as transmissible spongiform encephalopathies (TSE). They are fatal neurodegenerative diseases that include "scrapie" in sheep, Creutzfeldt-Jacob disease (CJD) and kuru in humans, and chronic wasting disease in deer. BSE-affected animals suffer from "hindquarters' paralysis, which is also one of the main features of "experimental allergic encephalomyelitis" (EAE). EAE is considered an animal model of Multiple Sclerosis (MS) and lower limb Atoxia is often observed in MS patients. The presence of clinical and histopathological similarities in these diseases suggests a common pathology. Specific brain peptides, which produce EAE, were shown to have "molecular mimicry" with the soil and skin saprophytic microbe, Acinetobacter. BSE-affected animals and patients suffering from MS have been found to have elevated levels of antibodies to both Acinetobacter and Pseudomonas bacteria, as well as autoantibodies to both white and gray matter brain components. The hypothesis is proposed that Acinetobacter/ Pseudomonas bacteria may have evoked both BSE and MS through the mechanism of "molecular mimicry" and autoimmunity in a similar way to Streptococcus microbes producing rheumatic fever and Sydenham's chorea. The possibility that CJD patients may show similar features remains to be determined.

SEASONAL FLUCTUATION OF MULTIPLE SCLEROSIS BIRTHS IN SARDINIA
Sotgiu S, Pugliatti M, Sotgiu MA, Fois ML, Arru G, Sanna A, Rosati G.
J Neurol. 2005 Jul 20

Study results from different geographical areas provide some circumstantial evidence that, when compared with the general population, people who later in life develop multiple sclerosis (MS) have a pattern of birth excess numbers in spring and late summer, which may disclose an association with MS-predisposing environmental agents. To identify the presence of season-related clusters of MS birth in Sardinia, we have designed a case-control study in the province of Sassari, Northern Sardinia, insular Italy, an area at very high and increasing risk for MS. Mean birth incidence rate of people with MS (810 cases) on a three- and six-month basis were compared with that of two control populations: the MS unaffected siblings (1069), sharing genetic material with patients, and a representative number of births (247,612) of the general population of the study area. We found that the birth in months peaking in spring significantly represents one risk factor for future MS development. This seasonal deviation of MS births reveals an intriguing epidemiological overlap with common environmental agents, which may open a new scenario of hypothetical explanations for environmental factors perhaps affecting the CNS at the crucial time of myelination or shaping the newborn immune system.

FIGHT THE BITE!
Join the "Swat Team" Against West Nile Virus
CO Dept. Health & Env.

West Nile virus is a disease that can be transmitted to humans by mosquitoes. Common in the Eastern Hemisphere for decades, it first appeared in the eastern U.S. in 1999 and now is in Colorado.

Nearly 3,000 human cases of the disease were reported in Colorado in 2003; 63 Coloradoans died from the disease and 861 were hospitalized. Most of those who became seriously ill recovered but some suffered permanent disabilities.

Only certain types of mosquitoes transmit the virus to people and only a small percentage of those mosquitoes carry the virus. The risks are low but why take chances? It is important that everyone use insect repellent containing DEET while outdoors to protect themselves from mosquitoes that carry this virus.

How the Virus is Spread:
The virus is carried long distances by infected birds. The virus is then spread locally by mosquitoes that bite the birds. The mosquitoes then spread the virus to other birds, animals and humans.

The risk of infection varies, depending on mosquito habitat, wind and other factors. Colorado's mosquito season is usually from early spring to mid-September, with the highest risk in August and September. There is a vaccine for horses. A human vaccine won't be available for several years. Dogs, cars and other animals can be infected but usually don't become ill and don't spread the virus. Health departments across the state track the virus by testing dead birds and mosquitoes and by monitoring human and horse cases. Some cities and counties have mosquito control programs to destroy mosquito larvae and adult mosquitoes.

Risks and Symptoms:
It is very rare to catch the virus. When bitten by an infected mosquito, most people will not become sick or will only have flu-like symptoms. However, the virus can be debilitating. Some individuals will become seriously ill and can suffer permanent disabilities and even death. Twenty percent of those infected become seriously ill. Signs of illness usually appear 3 to 14 days after being bitten.

People who become ill may have a flu-like illness, including fever; lethargy; severe headaches; muscle aches; and muscle weakness. Some have a rash, swollen lymph glands and vomiting. This West Nile fever may last up to two weeks and more serious forms of the illness may last much longer.

West Nile virus also may cause serious illness: encephalitis, swelling of the brain, meningitis, swelling of the brain's lining or the spinal cord, or paralysis. Initial symptoms of these forms of West Nile virus may include high fever, severe headache, neck stiffness, muscle weakness and tremors, mental confusion, convulsions, and coma. These severe infections can result in brain damage, hearing loss, movement difficulties, vision changes, permanent paralysis, or even death.

The various illnesses can affect people of all ages, but those over age 60 are the most likely to die from the disease. People with any of these symptoms must seek medical attention immediately.

Personal Protection Against Mosquitoes:
* Avoid being outdoors at dawn or dusk when mosquitoes are most active. If outdoors, use insect repellent on a regular basis. * Wear long-sleeved shirts and long pants outdoors.
* Your backyard or patio is not a "safe zone". Even a brief trip to the barbeque or garden allows time for an infected mosquito to bite, and most people are infected at or near their home.
* Keep doors and windows closed and/or properly screened to keep mosquitoes out.
* Repair and replace torn or damaged screens.

It is important that people take these personal protection tips seriously, especially the recommendation to use an insect repellent containing DEET. Make it a habit for both adults and children through the summer months.

Use Insect Repellent That Contains DEET…In the Back Woods and in the Back Yard!
*Repellents containing DEET are proven safe and effective in preventing mosquito bites.
*The higher the percentage of DEET in a repellent the longer the protection lasts.
*Choose a product containing the right amount of DEET to match the time spent outdoors: 25 percent DEET lasts up to five hours; 5 percent DEET lasts from 45 to 90 minutes.
* Use products containing 30% DEET or less for children. Repellents containing DEET should not be used on children under six months of age.
* Reellents that don't contain DEET may provide protection, but studies have shown that they do not provide protection as long as DEET.
* Clothing can be sprayed with insecticides containing DEET or permethrin. Always follow label directions.

Don't Breed Mosquitoes Around Your Home:
Eggs laid by mosquitoes in still water hatch in five to 10 days. If standing water is eliminated weekly, many eggs will be destroyed. An inch of standing water is all mosquitoes need to lay eggs Here are some effective things you can do:
* Remove standing water in ponds, ditches, gutters, flower pots, tires and cans.
* Check unusual items that might collect even small amounts of water, such as wheelbarrows, hubcaps, toys, garden equipment, pool covers, and plastic sheeting. Turn these items upside down to prevent them from holding water.
* Drill drainage holes in tire swings.
* Empty water in birdbaths and wading pools every week so mosquito larvae cannot survive.
* Treat livestock water tanks with BTI, a bacteria that kills larvae but is safe for animals. BTI is available at home and garden stores and is commonly called mosquito "dunks" or pellets.
* Stock ornamental ponds and foundations with fish that eat mosquito larvae or treat with BTI.
* Prevent standing water by not overwatering lawns and gardens.
* Trim shrubbery and remove garden debris.