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Thursday

 
This story & photo below are from: CelebCrust.com

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Britney Spears went for tanning in North Hollywood last Saturday. As usual the bad momma / horrible driver / crotch flasher continues to do something thats grabs your attention.

This time around, the troubled singer decided to skip the parking search and make herself a self-declared VIP parking. What? She just stole the handicap parking it from the disabled.

Can she get any worst?





 
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BIOMS MEDICAL’S RELAPSING-REMITTING MULTIPLE SCLEROSIS TRIAL RECEIVES POSITIVE REVIEW FROM DATA SAFETY MONITORING BOARD


Edmonton, Alberta, November 7, 2007 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

CLICK HERE TO GO: BIOMS MEDICAL
 
     

Saturday

 

long-term tolerability and effectiveness profiles for THC/CBD (Sativex (R)

1: Clin Ther. 2007 Sep;29(9):2068-79.

Oromucosal Delta(9)-tetrahydrocannabinol/cannabidiol for neuropathic pain associated with multiple sclerosis: An uncontrolled, open-label, 2-year extension trial.


Rog DJ, Nurmikko TJ, Young CA.
Walton Centre for Neurology and Neurosurgery, Liverpool, United Kingdom.

Background: Central neuropathic pain (CNP), pain initiated or caused by a primary lesion or dysfunction of the central nervous system, occurs in ~28% of patients with multiple sclerosis (MS). Delta(9)-Tetrahydrocannabinol/cannabidiol (THC/CBD), an endocannabinoid system modulator, has demonstrated efficacy for up to 4 weeks in randomized controlled trials in the treatment of CNP in patients with MS. Objective:

The purpose of this extension was to establish long-term tolerability and effectiveness profiles for THC/CBD (Sativex (R), GW Pharmaceuticals plc, Salisbury, United Kingdom) oromucosal spray in CNP associated with MS. Methods: This uncontrolled, open-label trial was an indefinite-duration extension of a previously reported 5-week randomized study in patients with MS and CNP. In the initial trial, patients were randomized to placebo or THC/CBD. Patients were only required to maintain their existing analgesia in the randomized study. In the open-label trial they could vary their other analgesia as required. All patients (placebo and THC/CBD) who completed the randomized trial commenced the open-label follow-up on THC/CBD (27 mg/mL: 25 mg/mL). Patients titrated their dosage, maintaining their existing analgesia. The primary end point of the trial was the number, frequency, and type of adverse events (AEs) reported by patients. Secondary end points included changes from baseline in 11-point numerical rating scale (NRS-11) neuropathic pain score, hematology and clinical chemistry test results, vital signs, trial drug usage, and intoxication visual analogue scale scores. Results: Sixty-six patients were enrolled in the randomized trial; 64 (97%) completed the randomized trial and 63 (95%) entered the open-label extension (race, white, 100%; sex, male, 14 [22%]; mean [SD] age, 49 [8.4] years [range, 27-71 years[). The mean (SD) duration of open-label treatment was 463 (378) days (median, 638 days; range, 3-917 days), with 34 (54%) patients completing >1 year of treatment with THC/CBD and 28 (44%) patients completing the open-label trial with a mean (SD) duration of treatment of 839 (42) days (median, 845 days; range, 701-917 days). Mean NRS-11 pain scores in the final week of the randomized trial were 3.8 in the treatment group and 5.0 in the placebo group. In the 28 (44%) patients who completed the 2-year follow up, the mean (SD) NRS-11 pain score in the final week of treatment was 2.9 (2.0) (range, 0-8.0). Fifty-eight (92%) patients experienced >/=1 treatment-related AE. These AEs were rated by the investigator as mild in 47 (75%) patients, moderate in 49 (78%), and severe in 32 (51%). The most commonly reported AEs were dizziness (27%), nausea (18 %), and feeling intoxicated (11%). Two treatmentrelated serious AEs (ventricular bigeminy and circulatory collapse) were judged to be treatment-related. Both serious AEs occurred in the same patient and resolved completely following a period of discontinuation. Eleven (17%) patients experienced oral discomfort, 4 persistently. Regular oral examinations revealed that 7 (11%) patients developed white buccal mucosal patches and 2 (3%) developed red buccal mucosal patches; all cases were deemed mild and resolved. Seventeen (25%) patients withdrew due to AEs. The mean number of sprays and patients experiencing intoxication remained stable throughout the follow-up trial.

Conclusions: THC/CBD was effective, with no evidence of tolerance, in these select patients with CNP and MS who completed approximately 2 years of treatment (n = 28). Ninety-two percent of patients experienced an AE, the most common of which were dizziness and nausea. The majority of AEs were deemed to be of mild to moderate severity by the investigators.

PMID: 18035205 [PubMed - in process]

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Friday

 

Statins--treatment option for central nervous system autoimmune disease?

Neurotherapeutics. 2007 Oct;4(4):693-700

Department of Neurology and Program in Immunology, University of California, San Francisco, California 94143, USA.

Statins, inhibitors of the enzyme 3-hydroxy-3-methylglutaryl coenzyme A reductase, are well-established agents to lower cholesterol levels and prevent cardiovascular morbidity. Independent of their lipid-lowering properties, statins have been shown to exert pleiotropic immunomodulatory effects in various animal models of human autoimmune disease.

In experimental autoimmune encephalomyelitis, a murine model for multiple sclerosis, statins prevented disease onset and even reversed paralysis when treatment was initiated after experimental autoimmune encephalomyelitis was fully established.

Furthermore, well-tolerated oral statins were recently shown to exert synergistic benefit in experimental autoimmune encephalomyelitis in combination with existing agents for multiple sclerosis therapy.

Based primarily on these encouraging results, statins are now being tested in clinical trials as a monotherapy for multiple sclerosis, as well as in combination with approved disease-modifying therapies.

PMID: 17920550 [PubMed - in process]

 

Psychological aspects of MS

...Clin Neurol Neurosurg. 2007 Nov 16

A significant incidence and prevalence of psychological disorders in multiple sclerosis (MS) has been reported. Their underlying mechanisms and the extent to which they are reactive to psychosocial factors or symptoms of the pathological process itself, remain unclear. Depression is the predominant psychological disturbance with lifetime prevalence around 50% and annual prevalence of 20%. Depression is commoner during relapses, may exacerbate fatigue and cognitive dysfunction and no firm evidence exists of its induction by interferon; instead, treating depression improves adherence to disease-modifying drugs. Anxiety is also frequent, occurs in newly diagnosed patients, and its co-morbidity with depression has been suggested to increase the rate of suicidal ideation. The relationship between stress and MS is an attractive issue because some studies pointed to an association between stressful life-events and MS onset/relapses; however, the evidence supporting this hypothesis is not conclusive so far. Other psychiatric illnesses, as bipolar affective disorder, pathological laughing and crying or psychosis occur less frequently in MS. Therapeutic strategies include psychotherapy, cognitive behavioural therapy, strengthen of coping, and specific medications. The "art" of the MS team in providing the best individualized care is emphasized, aiming to reduce the burden of the disease and improve the patients' quality of life.



 

STEM CELL TRANSPLANT CAN GROW NEW IMMUNE SYSTEM IN CERTAIN MICE, STANFORD RESEARCHERS FIND



STANFORD, Calif. -

Researchers at the Stanford University School of Medicine have taken a small but significant step, in mouse studies, toward the goal of transplanting adult stem cells to create a new immune system for people with autoimmune or genetic blood diseases.


The researchers found a way to transplant new blood-forming stem cells into the bone marrow of mice, effectively replacing their immune systems. Many aspects of the technique would need to be adapted before it can be tested in humans, said Irving Weissman, MD, a co-senior author of the study and director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine. The work was done on a particular group of mice that are a poor mimic for the human immune system. Still, Weissman suggested the remaining hurdles could eventually be overcome.

When those barriers are surmounted, the benefits are potentially big. The study will be published in the Nov. 23 issue of Science.

A person with an autoimmune disease such as multiple sclerosis has a defective immune system in which immune cells attack the person's own body. An immune system transplant, much like a liver or heart transplant, would give the person a new system that might not attack the body.

The way to get a new immune system is to transplant new blood-forming stem cells into the bone marrow, where they generate all the cells of the blood. But before transplanting new stem cells, the old ones first must be removed, which is currently done by intensive chemotherapy or radiation. Those processes eliminate the cells of the bone marrow, but also damage other tissue and can cause lasting effects including infertility, brain damage and an increased risk of cancer. A treatment for M.S. at the expense of brain function is hardly an ideal therapy.

Weissman and co-first author Deepta Bhattacharya, PhD, a postdoctoral scholar in Weissman's lab, thought one way around this problem would be to eliminate only the blood-forming stem cells without affecting bone marrow cells or other tissues. They worked with Agnieszka Czechowicz, first author and medical student, to accomplish that feat by injecting the mice with molecules that latch on to specific proteins on the surface of the blood-forming stem cells, effectively destroying the cells. That technique eliminated the blood-forming stem cells without otherwise harming the mice.

"It is essentially a surgical strike against the blood-forming stem cells," said Weissman, the Virginia & D.K. Ludwig Professor for Clinical Investigation in Cancer Research. When they transplanted new blood-forming stem cells into the mice, those cells took up residence in the bone marrow and established a new blood and immune system.

In a person with autoimmune disease, that new immune system would likely no longer attack tissues of the body. Likewise, in people with a genetic disorder such as sickle cell anemia, the new blood system would not have the sickle-cell mutation, eliminating the cause of disease. However, the barriers are still significant.

First, the researchers don't know whether the same molecule on human blood-forming stem cells would be the right one to target with a therapy. Also, the mice they used in the study lack a functioning immune system. They'll need to get the therapy working in mice with a normal immune system before they can begin testing the technique in humans.

Although these steps will take time to overcome, Weissman said he considered this work to be the beginning of research that could lead to human studies.

Daniel Kraft, MD, a postdoctoral scholar, also contributed to this work.

The work was funded by fellowships from the Stanford Medical Scholars Program, the Cancer Research Institute and by the National Institutes of Health.

Wednesday

 

"Scientists Bypass Need for Embryo to Get Stem Cells" - New York Times

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Published: November 21, 2007 Two teams of scientists reported yesterday that they had turned human skin cells into what appear to be embryonic stem cells without having to make or destroy an embryo — a feat that could quell the ethical debate troubling the field. All they had to do, the scientists said, was add four genes. The genes reprogrammed the chromosomes of the skin cells, making the cells into blank slates that should be able to turn into any of the 220 cell types of the human body, be it heart, brain, blood or bone. Until now, the only way to get such human universal cells was to pluck them from a human embryo several days after fertilization, destroying the embryo in the process. The need to destroy embryos has made stem cell research one of the most divisive issues in American politics, pitting President Bush against prominent Republicans like Nancy Reagan, and patient advocates who hoped that stem cells could cure diseases like Alzheimer's. The new studies could defuse the issue as a presidential election nears. The reprogrammed skin cells may yet prove to have subtle differences from embryonic stem cells that come directly from human embryos, and the new method includes potentially risky steps, like introducing a cancer gene. But stem cell researchers say they are confident that it will not take long to perfect the method and that today's drawbacks will prove to be temporary. Researchers and ethicists not involved in the findings say the work, conducted by independent teams from Japan and Wisconsin, should reshape the stem cell field. At some time in the near future, they said, today's debate over whether it is morally acceptable to create and destroy human embryos to obtain stem cells should be moot. "Everyone was waiting for this day to come," said the Rev. Tadeusz Pacholczyk, director of education at the National Catholic Bioethics Center. "You should have a solution here that will address the moral objections that have been percolating for years," he added. The White House said that Mr. Bush was "very pleased" about the new findings, adding that "By avoiding techniques that destroy life, while vigorously supporting alternative approaches, President Bush is encouraging scientific advancement within ethical boundaries." The new method sidesteps other ethical quandaries, creating stem cells that genetically match the donor without having to resort to cloning or the requisite donation of women's eggs. Genetically matched cells would not be rejected by the immune system if used as replacement tissues for patients. Even more important, scientists say, is that genetically matched cells from patients would enable them to study complex diseases, like Alzheimer's, in the laboratory. Until now, the only way most scientists thought such patient-specific stem cells could be made would be to create embryos that were clones of that person and extract their stem cells. Just last week, scientists in Oregon reported that they did this with monkeys, but the prospect of doing such experiments in humans has been ethically fraught. But with the new method, human cloning for stem cell research, like the creation of human embryos to extract stem cells, may be unnecessary. The new cells in theory might be turned into an embryo, but not by simply implanting them in a womb. "It really is amazing," said Dr. Leonard Zon, director of the stem cell program at Children's Hospital Boston at Harvard Medical School. And, said Dr. Douglas A. Melton, co-director of the Stem Cell Institute at Harvard University, it is "ethically uncomplicated." For all the hopes invested in it over the last decade, embryonic stem cell research has moved slowly, with no cures or major therapeutic discoveries in sight. The new work could allow the field to vault significant problems, including the shortage of human embryonic stem cells and restrictions on federal financing for such research. Even when scientists have other sources of financing, they report that it is expensive and difficult to find women who will provide eggs for such research. The new discovery is being published online today in Cell, in a paper by Shinya Yamanaka of Kyoto University and the Gladstone Institute of Cardiovascular Disease in San Francisco, and in Science, in a paper by James A. Thomson and his colleagues at the University of Wisconsin. Dr. Thomson's work received some federal money. While both groups used just four genes to reprogram human skin cells, two of the genes used differed from group to group. All the genes in question, though, act in a similar way — they are master regulator genes whose role is to turn other genes on or off. The reprogrammed cells, the scientists report, appear to behave very much like human embryonic stem cells but were called "induced pluripotent stem cells," meaning cells that can change into many different types. "By any means we test them they are the same as embryonic stem cells," Dr. Thomson says. He and Dr. Yamanaka caution, though, that they still must confirm that the reprogrammed human skin cells really are the same as stem cells they get from embryos. And while those studies are under way, Dr. Thomson and others say, it would be premature to abandon research with stem cells taken from human embryos. Another caveat is that, so far, scientists use a type of virus, a retrovirus, to insert the genes into the cells' chromosomes. Retroviruses slip genes into chromosomes at random, sometimes causing mutations that can make normal cells turn into cancers. One gene used by the Japanese scientists actually is a cancer gene. The cancer risk means that the resulting stem cells would not be suitable for replacement cells or tissues for patients with diseases, like diabetes, in which their own cells die. But they would be ideal for the sort of studies that many researchers say are the real promise of this endeavor — studying the causes and treatments of complex diseases. For example, researchers could make stem cells from a person with a disease like Alzheimer's and turn the stem cells into nerve cells in a petri dish. Then they might learn what goes awry in the brain and how to prevent or treat the disease. But even the retrovirus drawback may be temporary, scientists say. Dr. Yamanaka and several other researchers are trying to get the same effect by adding chemicals or using more benign viruses to get the genes into cells. They say they are starting to see success. "Anyone who is going to suggest that this is just a sideshow and that it won't work is wrong," Dr. Melton predicted. The new discovery was preceded by work in mice. Last year, Dr. Yamanaka published a paper showing that he could add four genes to mouse cells and turn them into mouse embryonic stem cells. He even completed the ultimate test to show that the resulting stem cells could become any type of mouse cell. He used them to create new mice. Twenty percent of those mice, though, developed cancer, illustrating the risk of using retroviruses and a cancer gene to make cells for replacement parts. Scientists were electrified by the reprogramming discovery, Dr. Melton said. "Once it worked, I hit my forehead and said, 'It's so obvious,'" he said. "But it's not obvious until it's done." The work set off an international race to repeat the work with human cells. "Dozens, if not hundreds of labs, have been attempting to do this," said Dr. George Daley, associate director of the stem cell program at Children's Hospital. Ever since the birth of Dolly the sheep in 1996, scientists knew that adult cells could, in theory, turn into embryonic stem cells. But they had no idea how to do it without cloning, the way Dolly was created. With cloning, researchers put an adult cell's chromosomes into an unfertilized egg whose genetic material was removed. The egg, by some mysterious process, then does all the work. It reprograms the adult cell's chromosomes, bringing them back to the state they were in just after the egg was fertilized. A few days later, a ball of stem cells emerges in the embryo, and every cell of the embryo, including its stem cells, is an exact genetic match of the adult. The abiding questions, though, were: How did the egg reprogram the adult cell's chromosomes? Would it be possible to reprogram an adult cell without using an egg? About four years ago, Dr. Yamanaka and Dr. Thomson independently hit upon the same idea. They would search for genes that are being used in an embryonic stem cell that are not being used in an adult cell. Then they would see if those genes would reprogram an adult cell. Dr. Yamanaka worked with mouse cells, and Dr. Thomson worked with human cells from foreskins. The researchers found more than 1,000 candidate genes. So both groups took educated guesses, trying to whittle down the genes to the few dozen they thought might be the crucial ones and then asking whether any combinations of those genes could turn a skin cell into a stem cell. "The number of factors could have been 1 or 10 or 100 or more," Dr. Yamanaka said in a telephone interview from his laboratory in Japan. If many genes had been required, the experiments would have failed, Dr. Thomson said, because it would have been impossible to test all the gene combinations. As soon as Dr. Yamanaka saw that the mouse experiments succeeded, he began trying the same brute force method in human skin cells that he had ordered from a commercial laboratory. Some were face cells from a 36-year-old white woman and others were connective tissue cells from joints of a 69-year-old white man. Dr. Yamanaka said he thought it would take a few years to find the right genes and the right conditions to make the human experiments work. Feeling the hot breath of competitors on his neck, he was in his laboratory every day for 12 to 14 hours a day, he said. A few months later, he succeeded. "We did work very hard," Dr. Yamanaka said. "But we were very surprised.

CLICK HERE TO GO TO THE NEW YORK TIMES


Sunday

 

Press Release: INITIATION OF ENROLLMENT IN PIVOTAL PHASE III CLINICAL STUDY OF ORAL LAQUINIMOD FOR RELAPSING-REMITTING MS



Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX NORDIC: ACTI) announced today the initiation of enrollment in the Allegro trial (assessment of oral laquinimod in preventing progression of multiple sclerosis). Allegro is a global pivotal, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of the oral investigational compound laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enroll approximately 1,000 patients with RRMS.

"Currently there are several RRMS treatments available; however, they are all administered via injection or infusion. An orally administered therapy brings us one step closer to offering patients and physicians a highly effective, new, convenient and less invasive method of drug delivery," said Doug Jeffery, M.D., Ph.D., Associate Professor, Wake Forest University Baptist Medical Center. "Previous Phase II studies have demonstrated positive results for laquinimod, and we hope that results from this pivotal Phase III trial will further reinforce these findings."

Recently, Teva concluded a 36-week extension of the 36-week Phase IIb core trial, which demonstrated that laquinimod 0.6 mg met its primary endpoint. The data from this extension trial further confirmed and strengthened the results from the initial 36-week Phase IIb trial. The majority of the patients that have participated in the trial are now receiving treatment with laquinimod in a continued open-label extension trial.

"The initiation of Phase III clinical trial is a critical milestone for Teva in our commitment to the MS community," said Moshe Manor, Group Vice President - Global Innovative Resources, of Teva Pharmaceutical Industries Ltd."We are excited about the development of Laquinimod, which together with Copaxone, will broaden our MS platform and position Teva as a leading company in the MS field".

Additional new data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13, 2007 in Prague, demonstrated that laquinimod reduced inflammation, demyelination and axonal damage in an animal model experimental autoimmune encephalomyelitis (EAE), indicating that the compound may have both anti-inflammatory and neuroprotective properties.
Based on encouraging results from various animal models, laquinimod is now being investigated for other autoimmune diseases.

"We are very pleased to see how Teva has successfully advanced the laquinimod clinical trial program in order to bring a novel, first-in-class product to the market for the treatment of MS," said Sven Andr?asson, President and CEO of Active Biotech AB.

The efficacy, safety, and tolerability of laquinimod will also be studied in an additional Phase III pivotal trial in RRMS (BRAVO), which is expected to begin enrollment in the first quarter of 2008. This trial is a multinational, multi-center, randomized, parallel-group, placebo-controlled study which will compare the effects of laquinimod to those of placebo, and provide risk-benefit data comparing once-daily orally administered laquinimod to a product presently used for treatment of RRMS (an active comparator). This study plans to enroll approximately 1,200 participants who will be followed for 24 months.

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Anti-depressant use in association with interferon and glatiramer acetate treatment in multiple sclerosis


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.

Patten SB, Williams JV, Metz L.
Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada T2 N 4N1.

Background Randomized controlled trials incorporating validated depression scales have failed to identify an association between interferon beta treatment and depression in MS. This is surprising since interferons used in other clinical contexts are considered capable of causing depression. The negative results in MS could be due inadequate power in the published trials. Methods In this study, longitudinal data from an IMS Health Canada database called the Therapy Dynamics database were analyzed. The database contains information about prescriptions filled at outpatient pharmacies in Canada, linked at the individual level over time periods as long as 36 months. Antidepressant prescriptions were used as a proxy indicator for depressive disorders. The frequency of antidepressant use was compared in cohorts treated with glatiramer acetate and interferon beta. Results No differences in the frequency of antidepressant treatment were observed. A large proportion (approximately 40%) in all treatment cohorts were treated with antidepressants at some time over the study interval. The proportions remained comparable after adjustment for age and sex and in a time-to-event analysis of new antidepressant prescriptions. Among patients receiving prescriptions exclusively from Neurologists, the frequency of exposure to antidepressants was much lower (2.4%).

Conclusions This analysis uncovered no evidence that antidepressant treatment occurs more often in people treated with interferon beta than in those treated with glatiramer acetate. These results help to confirm that depression is not associated with interferon beta treatment in MS.


PMID: 17986504 [PubMed - as supplied by publisher]

Thursday

 
Prozac May Help Reduce the number of New Brain lesions in patients with multiple sclerosis

Article provided by Sarafaith in Pembroke Pines, Fl.

Fluoxetine Shows Promise in Multiple Sclerosis CME
News Author: Thomas S. May
CME Author: Laurie Barclay, MD
Medscape Medical News



October 16, 2007 (Prague, Czech Republic) — Fluoxetine (Prozac) may help reduce the number of new brain lesions in patients with multiple sclerosis (MS), according to a study presented here at the ECTRIMS 2007: 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

The study, which was conducted by Jop P. Mostert, MD, and colleagues at the University of Groningen, the Netherlands, shows a trend toward a reduction in new enhancing lesions with fluoxetine treatment in patients with relapsing-remitting or relapsing secondary progressive MS.

Why Fluoxetine?

Fluoxetine, a selective serotonin reuptake inhibitor, was approved by the US Food and Drug Administration in 1987 and is frequently prescribed for the treatment of various psychiatric disorders, including major depression. However, fluoxetine also has a number of immunomodulatory effects, and previous studies have indicated that it might be beneficial for patients with MS, Dr. Mostert said in his presentation.

One of these earlier studies, which was first presented at the 1997 Annual Meeting of the American Association of Neurology, showed that fluoxetine reduced disease activity in experimental autoimmune encephalomyelitis, the animal model of MS, Dr. Mostert noted. "Furthermore, psychiatrists already reported in 1991 reduced MS in patients using fluoxetine," he added.

Previous research has also found that astrocytes in patients with MS lack beta-2 adrenergic receptors, and this leads to decreased cyclic adenosine monophosphate (cAMP) production, which in turn contributes to the initiation of the inflammatory cascade that eventually results in demyelination, Dr. Mostert explained. Because fluoxetine is able to increase the amount of cAMP in the astrocyte, the researchers hypothesized that the drug could help compensate for the loss of beta-2 adrenergic receptors and thus, reduce the amount of inflammation in MS.

Fewer New Lesions

To test their hypothesis, Dr. Mostert's team enrolled 40 patients (age 18 - 65 years) with relapsing-remitting or relapsing secondary progressive MS in a randomized, double-blind, placebo-controlled trial, with a duration of 24 weeks. Half of the patients were given fluoxetine (20 mg/day), whereas the remaining subjects received placebo.

The primary end point was the cumulative number of new gadolinium-enhancing lesions on T1-weighted magnetic resonance imaging (MRI) of the brain performed at weeks 4, 8, 16, and 24. Secondary outcome measures included changes in the Expanded Disability Status Scale (EDSS) and in the Multiple Sclerosis Self-Efficacy Scale (MSSE) from baseline to week 24.

The investigators found that the study drug was generally well tolerated, with only 1 patient dropping out because of adverse effects (nausea) in the treatment group. One patient also dropped out from the placebo group, leaving 19 completers in each group.

Regarding the primary end point, the results show that there was a trend toward a reduction in the number of new enhancing lesions in patients treated with fluoxetine. The mean (SD) cumulative number of new enhancing lesions during the 24 weeks of treatment was 1.84 (2.9) in the fluoxetine-treated patients and 5.16 (8.6) in the control subjects (P = .15).

At week 4, the cumulative number of new enhancing lesions was "quite comparable" in the two 2 groups, pointed out Dr. Mostert. He emphasized, however, that in the latter part of the trial, there was a steady increase in new lesions in the placebo group, while the number of lesions in the fluoxetine-treated patients remained relatively stable. Restricting the analysis to the last 16 weeks showed a "nearly significant" reduction in the cumulative number of new enhancing lesions and a higher number of patients without new enhancing lesions (63% vs 26%; P = .02).

Commenting on the study, session cochair Roland Liblau, MD, PhD, from Toulouse University Hospital in France, noted that the researchers used "a very interesting approach," because fluoxetine has a very good safety profile.

"It has been used in hundreds of thousands of patients, so we know it's safe," he told Medscape Neurology and Neurosurgery. "The possibility that it has even a slight effect in multiple sclerosis would be very interesting," he added. "The data showed a trend toward efficacy in MS, and I would strongly encourage further trials involving more patients."

This study was an investigator-initiated trial, with no pharmaceutical industry funding.

Pearls for Practice
In a 24-week, randomized, double-blind, placebo-controlled trial of 40 patients with relapsing-remitting or relapsing secondary progressive MS, there was a nonsignificant trend toward a reduction in the number of new enhancing MRI lesions in patients treated with fluoxetine, 20 mg/day. At week 4, the cumulative number of new enhancing lesions was similar in both groups. However, in the last 16 weeks, there was a nearly significant reduction in the cumulative number of new enhancing lesions and a higher number of patients without new enhancing lesions.
Fluoxetine was generally well tolerated, and only 1 patient dropped out because of adverse effects (nausea) in the treatment group. One patient also dropped out from the placebo group. Fluoxetine has a very good safety profile.

 
Alternative Computer Keyboards and Mice Provide Connected Opportunities for People with MS

myMS>myWay.com
By Ellen Kampel & John M. Williams


Shirley Thomson, 62, of New Plymouth, New Zealand was diagnosed with multiple sclerosis in 1994. When she was told she had MS, she didn't panic. She reasoned that she was going to live the best life she could. Priorities such as maintaining a job, remaining independent, staying connected and living an active and high quality of life became personal goals. Over the years, her muscle coordination deteriorated and made it difficult for her to use a standard computer keyboard she started looking at alternatives.

Two years ago, her life changed. She said, "I was in the hospital for a few days in August 2005. I was restless to go home, and persuaded the doctors to discharge me. That night I saw the Lomak (light operated mouse and keyboard) on television, and I knew I had to try this amazing keyboard."

She brought one, and today, she uses it from four-to-12 hours every day to write e-mails, letters and a biography of her father. Designed for people who have difficulty using a standard computer keyboard, Lomak is a hands-free keyboard and mouse that tracks a small light device mounted onto a headband worn by the user. Lomak moves the cursor by tracking head movements with a laser beam. The laser beam produces a keyboard or mouse action, and each keystroke is confirmed before being input. Lomak is also available in a hand-operated version.

"I just point the laser-beam light at my target in the center of the board and presto, I have computer access," Thomson said.

Lomak is not the only input device on the market for people with MS. There are a variety of assistive technologies available, including foot pedals, head-tracking pointers, joy sticks, tracking balls and other hands-free options. Alternative input devices are designed to utilize the strongest muscle groups to give people maximum control and minimize stress on weaker muscle groups.

Below are descriptions of input devices that can be used either alone or in combination to make the computer easier to use and in some circumstances, control other appliances .

Foot pedals allow hands-free activation commands that otherwise require a keyboard stroke or mouse click. Using their feet, users learn to use frequently assigned keys, key combinations, or macros.

Head-tracking pointers use a camera and allow users to control a mouse pointer with head and facial movements.

Joy-sticks control computer games and can control the cursor on other computer applications. Often a joystick has one or more push-buttons, called switches, whose position can also be read by the computer.

Track balls are another way to move the cursor and execute other mouse functions by moving or rotating the ball. A traditional mouse requires the user to grasp the mouse, move the mouse, and click a mouse button separately.

Descriptions of other alternative keyboards, such as a touch screen keyboard, on-screen keyboard and speech recognition are available on the MyMSMyWay Website.

There are also no cost ways to adjust the computer operating system to accommodate an individual's dexterity needs.

The Nouse-- is another example of a hands-free input device. The National Research Council (NRC) and the Elizabeth Breyer Research Institute in Ottawa, ON, Canada developed a "nose as mouse "technology called the Nouse, which uses a Web camera and integrated software to translate the nose movements of computer users into computer cursor movements and clicks. As Nouse users turn their heads the pointer follows across the screen. Tilting the head works the same as clicking a mouse button.

Between 10 and 15 patients at St. Vincent Hospital in Ottawa are testing the "Nouse" as a new alternative to a regular computer mouse . One of the patients, Linda Baker, has primary progressive MS, and she was on the Internet regularly until she lost mobility in her arms. She hopes the Nouse, or some other hands-free device, will enable her to get back online and reconnect with others who have MS.

"I have a rare form of the disease and it's kind of nice to talk to someone else who has the same kind - just to see what they're doing, how they're making out,"said Baker, who tries hard to be independent and uses her head to operate her wheelchair.

"The Nouse will open doors for many people," said Hilary McKee, an occupational therapist, who works at the Elizabeth Breyer Research Institute said,

"Computers are so integrated into our lives these days that it's really important for people with disabilities to be able to access the computer and use it to its full advantage,"McKee said.

Taking full advantage of the empowering effects of computers and their benefits to people with MS is also in line with Thomson's thinking.

"Multiple Sclerosis has made it almost impossible to use a conventional keyboard," Thomson said. "My alternative keyboard has given me freedom, independence and a sense of completeness. I am once again typing long e-mails and letters as well as performing countless other computing tasks," says Thomson.

Since fatigue is an important cause of early departure from the workforce, alternative input devices may help you stay employed longer. They can be used in occupational therapy to help simplify tasks at work and at home.

Experience dictates that you may need to experiment with many alternative input keyboards to discover the one that is right for you.

Ellen Kampel is the public affairs manager for the Accessibility Business Unit at Microsoft. John M. Williams has been writing about disability issues since 1978 and coined the phrase "Assistive Technology".

 
Support of Daughter Wins MS Award
By ANDREW POTTER


Recent winners of the Multiple Sclerosis Parents of the Year Award Wayne (left) and Diane Kreimeyer flank their daughter Lisa. Lisa was diagnosed with MS five years ago and Wayne and Diane received the award for the support they have given their daughter.

Since being diagnosed with Multiple Sclerosis five years ago there have been many ups and downs for Marshalltown’s Lisa Kreimeyer. One thing has been constant though — the support of her parents Diane and Wayne Kreimeyer.

As a result Diane and Wayne recently received the North Central States Chapter of the Multiple Sclerosis Society Parents of the Year Award.

Lisa nominated her parents for their support through her doctor’s appointments and help in every aspect of life.

“They‘ve been with me during doctor’s appointments,” Lisa said. “And recently they helped me get into a house. They’ve just been a good support system for me.”

Diane said getting the message that her and her husband won the award came as a surprise.

“I was shocked,” Diane said. “She didn’t tell us we were nominated. It was a very surprising and heartfelt moment.”

Wayne also was taken off guard after getting the call while he was on a fishing trip in Minnesota.

“We feel honored,” Wayne said.

Diane said her and Wayne are ready anytime to be by Lisa’s side when she has flare ups with blurred vision or trouble moving her hands and legs.

“Anytime she needs us, if she calls we’ll be right there,” Diane said.

Lisa is part of the Marshalltown Area Multiple Sclerosis Support Group that meets every other month.

“When you first get diagnosed with it you think there are not that many people out there with MS,” Lisa said. “But there’s a lot of people that have it. The group has helped me a lot.”

The next meeting of the group is Dec. 2 at 2 p.m. in Room A at the lower level of Marshalltown Medical and Surgical Center. For more information on the group call Lisa at 485-4191 or Bob Polley at 752-7404.

“Until you have somebody that has it you don’t realize how many people in the area have it,” Wayne said.

———

Contact Andrew Potter at 641-753-6611 or apotter@ timesrepublican.com


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