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Timothy L. Vollmer, MD
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Sunday

 
Hormonal Surge During Pregnancy Repairs Faulty Brain Signaling -- New study finds that the release of prolactin strengthens neuron insulation, which could one day help reduce the effects of multiple sclerosis: Scientific American.com:
In what could give hope to the 2.5 million sufferers of multiple sclerosis (MS) worldwide, a new study reports that the hormone prolactin, the levels of which spike during pregnancy, mended nerve damage in mice.

MS is a chronic degenerative disease that causes inflammation of the central nervous system. The onset of this disorder, which strikes women twice as frequently as men, is typically between the ages of 20 and 40 and is characterized by a multitude of symptoms ranging from muscle fatigue and short-term memory loss to complete loss of motility in severe cases. The illness is believed to result from impaired signaling between neurons in the brain caused by a reduction in myelin. This fatty material is an insulator covering and modulating a part of the nerve cell called the axon, which transmits electrical signals to other cells. The immune system in MS patients is known to disrupt myelin formation in axons and in the brain's white matter.

Symptoms of multiple sclerosis (MS) are known to abate during pregnancy, a phenomenon first documented by French scientists in 1998. Christian Confavreux, a neurologist at Pierre Wertheimer Neurological Hospital in Lyon, France, and a member of that team, says that pregnancy is more effective at keeping MS in check than drugs commonly used to treat it. "These observations imply looking for the immunological changes and also the hormonal changes pertaining to pregnancy," he says, "at the background of the beneficial effect."

Toward that end, scientists at the University of Calgary in Canada, devised several mouse models to help determine whether pregnancy affects myelin production.

"It was thought that during pregnancy, their immune systems no longer destroyed the myelin," says Samuel Weiss of Hotchkiss Brain Institute in Calgary and co-author of the study published in The Journal of Neuroscience. "No previous study has tested whether pregnancy actually results in the production of new myelin, which may explain [the] improvement of symptoms."

Weiss and his colleagues compared healthy pregnant and virgin mice of the same age to determine whether differences in myelin formation were taking place. The researchers found that there were twice as many oligodendrocytes (nerve cells that produce myelin) in the brains of pregnant mice and, also, that the mice continued to produce oligodendrocytes throughout their pregnancies, leading to 50 percent more myelin sheathing in their nerve cells than in those of their virgin counterparts.

The research team then injected both sets of mice with a detergent that caused the demyelination of their nerve cells. Two weeks later, the pregnant mice had doubled their output of myelin.

The scientists discovered that if they injected pregnant mice with prolactin, the healthy animals produced more myelin and the demyelinated mice formed new myelin. The reason, say researchers: the hormone stimulates production of more oligodendrocyte stem cells, leading to more oligodendrocytes and therefore more myelin. The authors state that myelin formation was also improved in male mice, which showed an increase in prolactin levels.

"This study provides compelling evidence that the maternal brain is dynamic and provides meaningful clues about the mechanisms of neuronal plasticity," says Kelly Lambert, chair of the psychology department of Randolph-Macon College in Ashland, Va. "Learning more about how the brain changes to adapt to increased environmental demands will lead to an enhanced understanding of many clinical conditions haunting the human nervous system today—MS, learning disabilities, Alzheimer's disease—as well as provide clues about experiencing a more seamless aging process."

The Calgary group is planning to do more animal testing to determine prolactin's effectiveness in treating MS. Weiss says that if all goes well, the hormone could then move on to human testing. Confavreux says that patients in France and Italy are currently being enrolled in an MS treatment study using progesterone, another of the hormones that surge during pregnancy.

Thursday

 

Multiple sclerosis hits women more than men - CNN.com

Multiple sclerosis is an unpredictable disease that can produce mild to severe symptoms. Dr. David Dawson, a neurologist at Brigham and Women's Hospital in Boston, Massachusetts, spoke with CNN about the condition.

CNN: What is multiple sclerosis or MS?
Dawson: MS is an autoimmune disease. Your immune system is making an error and is attacking your nervous system. It starts off as attacks of illness, typically with a relapse, which starts off in a few days, lasts for a few weeks and goes away again.

CNN: How prevalent is it in the United States?
Dawson: It is the leading cause of neurological disability in young adults in this country. Most of the time it starts in your 20s and 30s. Women are a bit more likely than men to have the condition. The ratio is something like three to two women over men, and it tends to run in families.

CNN: Do you know what causes MS?
Dawson: I don't think anybody knows that. We're making a lot of progress in controlling the disease without actually knowing what the cause is. It's clear that there is a genetic component. It runs in families. It is much more likely to occur in someone who is from a European background -- English, Irish, German, Italian -- than it is in someone who is from the Far East or parts of Africa where no one ever gets MS.

CNN: What are the signs and symptoms?
Dawson: Typically, at the start, it shows up as some neurological loss of control. It could be vision. It could be clumsy walking. It could be weakness in one arm. It could be numbness somewhere. Often at the beginning it is quite mild and the patient may not get diagnosed for a year or two after the first symptom because the symptoms go away, they are kind of written off. As time goes by, the attacks or relapses as they are called become more obvious, more definite and it's clear that there is something wrong.

CNN: How is it diagnosed?
Dawson: The diagnosis is greatly assisted by MRI scanning. It's a way of assessing the disease at a very early stage of illness. Areas of inflammation in your brain and spinal cord show up as little white spots. They are very easy to see. What's needed is for the scan to be done at an early stage so that the disease can be diagnosed and the proper treatment started.

CNN: Can you control the disease with medication?
Dawson: There are a number of symptomatic treatments for stiffness, pain, tingling and depression. They don't influence the course of the disease, but they are important in relieving the symptoms. Then there are things called DMAs or disease-modifying agents. These are things you take on a regular basis that are meant to control the illness, stop it from progressing. Patients who are on those medications do quite a lot better than those who are not taking them.

CNN: Can diet and exercise help control MS?
Dawson: Diet and exercise are very important for people who are faced with a neurological disability. The people who exercise, don't gain weight and don't smoke, do much, much better.


Wednesday

 
ABC News: Ann Romney: I'm Healthy Despite Multiple Sclerosis (click here to watch video)
Presidential Contender Mitt Romney, R-Mass. and His Wife Ann Discuss Her Diagnosis with Multiple Sclerosis

Republican former Massachusetts Gov. Mitt Romney and his wife, Ann Romney, sat down with ABC News' George Stephanopoulos. In a Sunday exclusive, they discussed Ann Romney's health and how it may affect his campaign. Following is an excerpt from their conversation, which will air this Sunday on "This Week."

George Stephanopoulos: Your sister, Jane, says you have lived a charmed life. What's the toughest personal crisis you've ever had to face?

Former Gov. Mitt Romney, R-Mass.: Well, the charm in my life is that I fell in love young. And you can't imagine what a blessing it is, in my opinion, to find your soul mate so young, to raise five kids together, and to see them get married and have children of their own. It's an extraordinary blessing. But without question, the most difficult time in our life was when Ann was diagnosed with multiple sclerosis.

Stephanopoulos: In 1998.

Ann Romney: Yes.

Mitt Romney: And we were in the doctor's office and she was going through a series of neurological tests.

Ann Romney: I was flunking everything.

Mitt Romney: Her right side wasn't working and we were thinking it could be Lou Gehrig's disease. And we said to each other, "As long as it's not fatal, we can live with anything."

Ann Romney: Well, he thought that.

Mitt Romney: You weren't sure about that.

Ann Romney: No, I was really, really troubled by the disease. It was really tough for me.
It was, obviously, hard for Mitt emotionally to have to support me during that, but for me, I am a physical person that loves action and loves to be involved in sports, and I was a tennis player at that point, and I, interestingly enough, had thought, "My gosh, I'm at the end of my 40s, almost 50 years old, I've made it through that period of life where people get diagnosed with MS."

I mean, I was thinking these thoughts, and then to actually have that diagnosis was just such a stunning blow to me.

Stephanopoulos: You're healthy now.

Mitt Romney: She's healthy.

Ann Romney: I am now.

Mitt Romney: She won't brag on herself, but she's really extraordinary. Of course, she used traditional medicine and Eastern medicine, everything she could think of to get herself strong. But she also started riding horses again.

Continued

 

With Multiple Sclerosis, 'Permanent Arrest' May be Temporary - CME Teaching Brief® - MedPage Today

VANCOUVER, British Columbia, Feb. 16 -- It can take more than a decade, but multiple sclerosis patients in a state of "permanent arrest" can find their relatively benign disease progressing.

Among patients who 10 years after a MS diagnosis still had only mild symptoms or no disability, nearly half had significant disease progression after another 10 years, reported Ana-Luiza Sayao, M.D., of the University of British Columbia here, and colleagues.

Approximately 21% became severely disabled and mobility restricted, requiring the use of a cane, and 23% went on to develop secondary progressive MS two decades after symptom onset, the investigators reported in the Feb. 13 issue of Neurology.

"We hoped to identify risk factors that make people more likely to progress in the disease after 10 years of a benign course, but we did not find that gender, the symptoms when the disease began, or age when the disease began were associated with either disease progression or remaining benign," said Virginia Devonshire, M.D., a co-author. "More research needs to be done to identify criteria to determine which people will remain with mild disability over the long term."

As other investigators have shown, the Expanded Disability Status Scale (EDDS) score at 10 years was the only predictor of benign disease at 20 years, yet even this marker was inadequate for describing the disease in the cohort, the authors said.

But as researchers from the Netherlands reported in a separate study in a different journal, MRI scans showing brain changes at the time of diagnosis appear to hold clues to disease progression.

(MORE)

 

Marijuana Linked to Respiratory Complications - CME Teaching Brief® - MedPage Today

NEW HAVEN, Conn., Feb. 14 -- In the long run, smoking marijuana has many of the same effects as smoking cigarettes, such as coughing and wheezing, according to researchers here.

So found a Yale-led team on the basis of a systematic review of 34 studies that evaluated the effect of marijuana smoking on pulmonary function and respiratory complications and bronchodilation, reported Jeanette Tetrault, M.D., and colleagues, in the February issue of Archives of Internal Medicine.

"While there is convincing data on the effects of tobacco smoke on pulmonary clinical outcomes, the effect of marijuana smoke has been poorly understood," Dr. Tetrault said.

To attempt to fill the gap, she and colleagues divided eligible studies into three groups -- challenge studies that experimentally examined airway response to marijuana smoke, studies that looked at changes in pulmonary function associated with long-term use, and studies that looked at respiratory complications associated with long-term use. Some studies fell into more than one category.

(MORE)

 
A hormone produced during pregnancy helps to push multiple sclerosis into remission in mice, Canadian researchers have found
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[Photo: he hormone prolactin leads to the regeneration of protective nerve coatings, Dr. Samuel Weiss says.
(CBC)]

A hormone produced during pregnancy helps to push multiple sclerosis into remission in mice, Canadian researchers have found.

Scientists have long known that MS tends to ease during pregnancy. The finding prompted Samuel Weiss of the Hotchkiss Brain Institute at the University of Calgary and his team to look at whether prolactin reverses damage from MS in mice.

The results appear in Wednesday's issue of the Journal of Neuroscience.

Prolactin stimulates breast development and milk production and has been tested in humans for other reasons.

"It's early to be confident that prolactin will definitely work with people," said Weiss. "But prolactin represents the first example of any molecule, in this case a naturally occurring molecule, that can actually boost the repair of myelin."

New direction for research

While current MS treatments are designed to prevent new damage in patients in earlier stages of the disease, there is nothing to repair myelin that has already been destroyed.

"This may give us some ways to now focus on protecting the brain, as opposed to giving therapies that just reduce the attacks," said Dr. Jock Murray, a professor of medicine at Dalhousie University and founding director of its multiple sclerosis research unit.

The Calgary team compared pregnant and virgin female mice of the same age to count the number of myelin-producing cells. They found pregnant mice had:

**Twice as many of the cells.

**50 per cent more myelin coating their nerve cells after giving birth.

**Twice as much new myelin after it was chemically destroyed.

Prolactin may help promote growth of myelin, although trials for MS treatments based on the findings remain about five years away.

Prolactin may also be beneficial for other diseases in which myelin is involved, such as spinal cord injuries and stroke, said Fred Gage of the Salk Institute, who did not participate in the research.MORE

Tuesday

 
One Utahn with MS Experiencing a Miraculous Recovery KSL-TV - Salt Lake City,UT,USA

GOOGLE ALERT ~ One Mans Amazing Multiple Sclerosis Story

A key employee for Salt Lake County Government with Multiple Sclerosis is out of his wheel chair, WALKING, sometimes even without a cane. ...
<http://www.ksl.com/?nid=148&sid=909753&comments=true>


Sunday

 

New and Improved Copaxone?

New and Improved Copaxone?
Here is a story our friend Jayce sent to us about a company improving on Copaxone. Supposedly it will work more efficiently and only be needed to be injected subcutaneously once a week--eliminating the other six injections (yea!).
Abstract from ECTRIMS 2006 below...
Immunomodulation of experimental autoimmune encephalomyelitis by the novel copolymer PI-2301
B. Carrillo-Rivas, J.T. Kovalchin, J. Krieger, M. Augustyniak, I. Dufour, K. Johnson, H.M. Genova, K. Rafuse, A. Ward, S. Baldwin, R. Kolbeck, J-C. Gutierrez-Ramos, E. Zanelli (Cambridge, USA)
Years of clinical experience have shown that daily subcutaneous administration of the peptide copolymer Copaxone™ (Cop-1), a mixture of millions of peptides composed of the four amino acids YEAK in random order, is a safe and efficacious treatment for relapsing-remitting multiple sclerosis (RR-MS).
Cop-1 was modeled to mimic myelin basic protein (MBP) and turned out to ameliorate experimental autoimmune encephalomyelitis (EAE) in mice, most likely by shifting the immune response away from an effector TH1 to an immunoregulatory TH2/TH3 immune response through presentation by MHC class II molecules.
Recently, a series of new peptide copolymers have been synthesized with the goal to improve the in vivo efficacy of Cop-1. In the present study, we show that Copolymer PI-2301 produced by substituting E with F has improved beneficial effects in a relapsing-remitting murine model of EAE.
Unlike Cop-1, PI-2301 shows long-term therapeutic efficacy when administered either daily or weekly at disease onset. In an adoptive EAE setting, efficacy of PI-2301 administered daily at the time of autoreactive lymph node cell transfer correlates with decreased serum level of Metalloproteinase-9 and increased level of Metalloproteinase Inhibitor-1.
Antibody production against PI-2301 and T-cell recall proliferation assay using splenocytes from PI-2301-treated mice underscore the induction of a TH2/TH3 immunity. Evidences of the expansion of T-cells with regulatory properties expressing Forkhead box protein P3 (FoxP3) and producing Interleukin-10 following PI-2301 treatment are also apparent.
We propose that PI-2301 is a potential novel immunomodulatory compound for the treatment of RR-MS. Clinical trials will soon be started to test this hypothesis.
Also, here's a link to the company developing the drug. Interestingly though, it isn't Teva pharmaceuticals.

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Wednesday

 

Varicella Zoster Often Found in Cerebrospinal Fluid of MS Patients

NEW YORK (Reuters Health) Feb 08 - Cerebrospinal fluid from multiple sclerosis patients commonly contains varicella zoster virus DNA, Italian researchers report in the February issue of the Journal of Medical Virology.

"Our data on varicella zoster virus and multiple sclerosis suggest that the interaction between viruses, in particular, latently infecting viruses, and multiple sclerosis is more complex than expected," Dr. Pasquale Ferrante from the University of Milan, told Reuters Health.

Dr. Ferrante and associates examined cerebrospinal fluid samples from 85 individuals (38 with multiple sclerosis, 28 patients with other neurological diseases, and 19 without neurological diseases) for the presence of genomic DNA from varicella zoster virus, herpes simplex virus-1 and -2, human cytomegalovirus, Epstein-Barr virus, JC virus, and human herpes virus 6.

[MORE]


 

Ski event March 3 to benefit MS: Sunrise Park Resort, AZ

The popular Jimmie Heuga Vertical Express for MS is back on the White Mountains, and this year there's plenty of snow, unlike last year when the event had to be cancelled.

The Jimmie Heuga 2007 Vertical Express for MS will take place Saturday, March 3 at Sunrise Ski Resort.

The Vertical Express for MS benefits The Heuga Center, a national, non-profit organization based in Edwards, Colorado. It is dedicated to improving the lives of people and families living with MS through interactive educational programs unique in all the world. Because of fund-raising efforts, many local families dealing with Multiple Sclerosis have had the opportunity to attend Heuga Center programs.

Anyone who enjoys skiing and competition and a day of fun can join in the event. Great prizes will be awarded in several different categories, so skiers and boarders at any level are welcome. All you have to do is form a team of three and raise some funds. In addition to the day-long competition at Sunrise, there will be a reception the night before at Hollywood and Wine and an awards reception March 3. The event is also seeking donations from local businesses.

For more information, visit http://www.sunriseheuga.org/ or call 928-205-5137.


 

Workplace alternatives exist for employees with MS
By ALLAN APPEL Scripps Howard News Service February 09, 2007

- An employer has numerous alternatives to meet the challenge of accommodating an employee with multiple sclerosis.

The Job Accommodation Network is a free service sponsored by the U.S. Labor Department's Office of Disability Employment Policy. That office publishes a series of fact sheets suggesting how an employer can accommodate employees with specific conditions. One of those fact sheets spotlights employees with multiple sclerosis.

MS is a chronic disease affecting the central nervous system. It manifests itself in any number of ways, including paralysis, impairment of vision, numbness in the limbs, extreme fatigue or spasticity, just to name a few. And no two people with MS are necessarily affected in the same way. The condition may also alternatively enter periods of remission and exacerbation.

Fatigue and muscle weakness are among the more common symptoms of MS. The fact sheet suggests scheduling periodic rest breaks away from the workstation to alleviate those symptoms. Ergonomic design of the components of that workspace (e.g., chair, desk, keyboard, etc.) can also assist the employee. And an employer can always institute a flexible work schedule or devise a plan for the employee to work at home. [more...]


 
"PRESS RELEASE FROM JOHNS HOPKINS UNIVERSITY: CALL MADE FOR CHANGES IN WOMEN'S HEART DISEASE RISK-FACTOR LIST"
-- Family history and blood C-reactive protein should be added to traditional risk factors for all older women

Johns Hopkins cardiologists are calling for an expansion of the criteria widely used by physicians to detect and assess a postmenopausal woman's chances of developing cardiovascular disease, the leading cause of death among women in the United States.

In an editorial appearing in the Journal of the American Medical Association (JAMA) online Feb. 14, Roger Blumenthal, M.D., and colleagues say that a family history of heart disease and blood levels of a protein tied to vessel inflammation, C-reactive protein, should quickly be added to traditional assessments of women's risk of suffering a heart attack, stroke or severe chest pain (angina).

"Physicians should incorporate these factors into their testing and decision-making about which women are most likely to develop cardiovascular disease," says Blumenthal, an associate professor and director of the Ciccarone Preventive Cardiology Center at The Johns Hopkins University School of Medicine and its Heart Institute. "And physicians should intervene with lifestyle changes and drug treatment before symptoms start to appear," he adds. "Our best means of prevention is through early identification of those most at risk."

Blumenthal says these changes could help ameliorate the discrepancy between the death rate for men and women from cardiovascular disease, which has steadily declined for men over the last 20 years, but has remained relatively the same for women.

The new risk-factor list would strengthen existing assessment tools, including the Framingham Risk Estimate, which gauges how likely a person is to suffer a fatal or nonfatal heart attack within 10 years and calculates risk based on a summary score of such factors as age, blood pressure, cholesterol levels and smoking.

The Johns Hopkins experts base their editorial call on research conducted elsewhere and published in the same issue of JAMA, which looked at the predictive value of more than 35 risk factors not included in the Framingham score but reported to play a role in heart disease and stroke.

They found clear evidence that only family history and C-reactive protein, or hsCRP for short, had significant, additional predictive value in determining women really at moderate or high risk of future cardiovascular disease. The new method changed risk scores for at least 20 percent of the women studied.

"These are the best data yet to show how we should be assessing our female patients," says Blumenthal, whose own research showed in 2005 that the gold standard Framingham tool failed to identify approximately one-third of women over age 60 who had advanced hardening and narrowing of the arteries for their age and sex.

The latest findings are not surprising, the Johns Hopkins team says. Family history - where either a parent or a sibling suffered a coronary event - doubles a woman's own chances of arterial disease. High blood levels of C-reactive protein, in excess of 3 milligrams per liter, also double the risk. And the effects are multiplied if both factors are present, with a woman's risk rising almost fourfold.

Also in 2005, Blumenthal and his team suggested additional screening, using CT scans of the arteries and calcium scoring to better find women who would likely benefit from aspirin and statin therapy. Such additional tests, he says, should still be considered for those women with no symptoms and at least two traditional risk factors who are also undergoing lifelong drug therapy with aspirin and lipid-lowering drugs.

But, he notes, the latest analysis, which was funded by the Donald W. Reynolds Foundation, provides a thorough review of many potential risk factors and should be applied for all postmenopausal women. Results are available online at http://www.reynoldsriskscore.org/

Evaluation of the women in the current study included analysis of race, age, body mass index, menopause status, frequency of exercise, alcohol use, postmenopausal hormone use and dietary supplements of vitamin E, other multivitamins and aspirin. Blood factors studied were equally varied and included levels of homocysteine, creatinine, fibrinogen and hemogloblin A1C levels.

The information came from the U.S. Women's Health Study, which tracked for a decade more than 24,000 healthy women to see who developed coronary heart disease and who didn't. All women were over age 45.

"Our goal is to make heart attacks less likely to occur, and to do so by strongly considering therapies such as aspirin, cholesterol-lowering medications and, possibly, blood pressure medications for individuals at higher risk," says editorial co-author and cardiologist Erin Michos, M.D., a clinical fellow at Johns Hopkins.

In addition to researchers' call for change, Michos says that existing treatment guidelines, the 2001 National Cholesterol Education Program Adult Treatment Panel, which currently emphasize the Framingham score, should be revised to incorporate family history and hsCRP.

Assistance with the Johns Hopkins editorial was provided by Khurram Nasir, M.D., M.P.H.

Monday

 
Benign MS May Not Stay Benign, Nearly Half Of "Benign Multiple Sclerosis" Cases Worsen Decades Later, Study Shows - CBS News
(WebMD) Nearly half of cases called benign multiple sclerosis may unpredictably worsen decades after diagnosis, a Canadian study shows.

The findings suggest that doctors should be cautious about using the term "benign multiple sclerosis" or "benign MS."

"We need to be careful what we tell people, and not give them false hope that their symptoms may never get worse," says Ana-Luiza Sayao, MD, in a news release.

Sayao works in Vancouver at the University of British Columbia.

She and her colleagues studied 169 patients with "benign MS," which the researchers defined as having a low level of disability 10 years after diagnosis.

Multiple sclerosis is a disease of the brain and spinal cord. Its symptoms may include vision problems, muscle weakness, and difficulty with walking, coordination, and balance.

Some patients experience relatively mild MS; other cases are severe.

Changes in 'Benign' MS

Sayao and colleagues checked the patients' medical records 20 years after MS diagnosis.

Just more than half the patients — 52 percent — still had "benign MS," meaning their disability was still relatively mild 20 years after MS diagnosis.

But disability had worsened in the other patients.

Of all the patients studied, roughly one in five needed a cane to walk 20 years after their MS diagnosis.

Sayao's team found no factors — such as patients' sex or age at MS onset — that predicted which cases would worsen.

Benign Really?

The study questions the use of the term "benign multiple sclerosis."


"Although there is certainly a unique subgroup of patients with MS who remain mild in disability over the long term, a lack of consensus in the criteria that define 'benign' MS continues to exist," the researchers note.

Journal editorialist Scott Pittock, MD, agrees.

"Whether there is a benign form of multiple sclerosis continues to be a controversial issue," writes Pittock, who works at the Mayo Clinic in Rochester, Minn.

Pittock says "a 'watchful waiting approach,' with regular clinical and MRI monitoring" may be preferable for some patients with benign MS before starting MS drug treatment.

He also sees reason for optimism for such patients.

"The MS prognostic glass is half full for a high proportion of these most benign cases," Pittock writes.



SOURCES: Sayao, A. Neurology, Feb. 13, 2007; vol 68: pp 496-500. Pittock, S. Neurology, Feb. 13, 2007; vol 68: pp 480-481. News release, American Academy of Neurology.

Tuesday

 

DR. TIMOTHY VOLLMER'S NEW STUDY WAS JUST PUBLISHED IN THE MAJOR MEDICAL JOURNALS THROUGHT THE WORLD!

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This study on the new oral MS drug Fampridine-SR was performed by Dr. Vollmer and 4 Doctors from the University of Rochester... Mellen Center, Cleveland Clinic Foundation...Washington University of St Louis and Yale University!


Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study

ABSTRACT:
Objective
To determine the safety of sustained-release 4-aminopyridine in subjects with mutiple sclerosis (MS) and to examine dose-related efficacy up to 40 mg twice daily.

Methods
Multicenter, randomized, double-blind, placebo-controlled, study. Following a 4-week baseline peroid, subjects were randomly assigned to receive Fampridine-SR (n=25, doses from 10 to 40 mg twice daily, increasing in 5 mg increments weekly) or placebo (n=11). A battery of assessments was performed weekly, including the MS Functional Composite (MSFC), fatigue questionnaires, and lower extremity manual muscle testing.

Results
Improvement were seen in lower extremity muscle strength (prospective analysis) and walking speed (post-hoc analysis) in the Fampridine-SR group compared to placebo (unadjusted p-values of 0.01 and 0.03, respectively). There were no significant differences in other MSFC measure or fatigue scores.

The most common adverse events were dizziness, insomnia, paresthesia, asthenia, nausea, headache, and tremor. Five subjects were discontinued from Fampridine-SR because of adverse events at doses greater than 25 mg, and these included convulsions in two subjects at doses of 30 and 35 mg twice daily.


Conclusions
Future studies should employ doses up to 20 mg twice daily with lower extremity strength and walking speed as potential outcome measures.

Saturday

 
BREAKING NEWS: 18 MILLION U.S. MEN AFFECTED BY ER*CT*LE DYSFUNCTION - Lifestyle Changes Could Improve Male Sexu*l Function
(PRESS RELEASE FROM: Johns Hopkins University)

From: Johns Hopkins University
Date: February 1, 2007 3:00:00 AM MST
Johns Hopkins University Bloomberg School of Public Health
Office of Communications and Public Affairs

NOTE: Due to its subject matter, some words in this release have been edited to avoid its being captured by spam filters

FOR IMMEDIATE RELEASE
18 MILLION U.S. MEN AFFECTED BY ER*CT*LE DYSFUNCTION
- Lifestyle Changes Could Improve Male Sexu*l Function

More than 18 million men in the United States over age 20 are affected by er*ct*le dysfunction, according to a study by researchers from the Johns Hopkins Bloomberg School of Public Health.
The prevalence of er*ct*le dysfunction was strongly linked with age, cardiovascular disease, diabetes and a lack of physical activity. The findings also indicate that lifestyle changes, such as increased physical activity and measures to prevent cardiovascular disease and diabetes, may also prevent decreased er*ct*le function. The study is published in the Feb. 1, 2007, issue of the American Journal of Medicine.

"Physicians should be aggressive in screening and managing middle-aged and older patients for er*ct*le dysfunction, especially among patients with diabetes or hypertension," said Elizabeth Selvin, PhD, MPH, lead author of the study and a faculty member in the Bloomberg School of Public Health's Department of Epidemiology. "The associations of er*ct*le dysfunction with diabetes and cardiovascular risk factors may serve as powerful motivators for men who need to make changes in their diet and lifestyle."

For the study, the research team analyzed data from 2,126 men who participated in the National Health and Nutrition Examination Survey (NHANES). Men who reported being "sometimes able" or "never able" to get and keep an er*ct*on were categorized as having er*ct*le dysfunction, while men who reported being "always or almost always able" or "usually able" were not.

The overall prevalence of er*ct*le dysfunction among men in the United States was 18 percent. Men aged 70 and older were much more likely to report having er*ct*le dysfunction compared to only 5 percent in men between the ages of 20 and 40. Nearly half of all men in the study with diabetes also had er*ct*le dysfunction. And, almost 90 percent of all men with er*ct*le dysfunction had at least one risk factor for cardiovascular disease, including diabetes, hypertension, having poor cholesterol levels or being a current smoker. Men with er*ct*le dysfunction were also less likely to have engaged in vigorous physical activity within the month prior to participation in the study.

###
"Prevalence and Risk Factors for Er*ct*le Dysfunction in the U.S." was written by Elizabeth Selvin, PhD, MPH, Arthur L. Burnett, MD, and Elizabeth A. Platz, ScD, MPH. Selvin and Platz are with the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. Platz and Burnett are with the James Buchanan Brady Urological Institute at Johns Hopkins Hospital.

 
Opexa Achieves Midpoint in Patient Admissions in Phase IIb Trial of Tovaxin for Multiple Sclerosis

BUSINESS WIRE - Opexa Therapeutics, Inc., a company involved in the development and commercialization of cell therapies, announced today that it has admitted the first 75 patients in its 150-patient Phase IIb clinical trial of Tovaxin(TM) in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 34 trial sites in the U.S., all of which are actively recruiting patients.

David McWilliams, president and chief executive officer of Opexa, commented, "Given the efficacy and safety demonstrated in our Phase I/II study of Tovaxin and the emerging understanding in the scientific literature of the involvement of pathogenic T-cells in multiple sclerosis, this trial has been highly anticipated in the MS community. We are excited about the enrollment interest we are receiving and feel comfortable that we will be able to achieve our 100% enrollment goal in the first half of this year."

Jim Williams, Ph.D., chief operating officer of Opexa, commented, "We are pleased to have reached this important milestone in our clinical program for the development of Tovaxin as a first line therapy for multiple sclerosis. The admission of 75 patients into the Phase IIb trial attests to the ability of Opexa to organize its clinical trials, including patient recruitment, site selection and manufacturing capacity as we meet the challenge of developing a patient-specific autologous T-cell vaccination therapy for multiple sclerosis."

As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.
All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

 
Ginkgo biloba for the improvement of cognitive performance in multiple sclerosis: a randomized, placebo-controlled trial

Abstract: Objectives To determine if Ginkgo biloba (GB) improves the cognitive performance of subjects with multiple sclerosis (MS).

Methods Randomized, double-blind, placebo-controlled trial of GB, 120 mg twice a day or placebo for 12 weeks. The primary outcomes were: the long delay free recall from the California Verbal Learning Test-II; the Paced Auditory Serial Addition Test; the Controlled Oral Word Association Test; the Symbol Digit Modalities Test; Useful Field of View Test; and the color-word interference condition from the Stroop Color and Word Test.

Results On completion, the GB group (n=20) was 4.5 seconds (95% confidence interval (CI) (7.6, 0.9), P=0.015) faster than the placebo group (n=18) on the color-word interference condition of the Stroop test. Subjects who were more impaired at baseline experienced more improvement with GB (treatment*baseline interaction, F=8.10, P=0.008). We found no differences on the other neuropsychological tests. Subjects on GB reported fewer cognitive difficulties in the Retrospective Memory Scale of the Perceived Deficits Questionnaire than subjects on placebo (1.5 points, 95% CI (2.6, 0.3), P=0.016). No serious drug related side-effects occurred and GB did not alter platelet function assays.

Conclusion Overall, GB did not show a statistically significant improvement in cognitive function. A treatment effect trend, limited to the Stroop test, suggests that GB may have an effect on cognitive domains assessed by this test, such as susceptibility to interference and mental flexibility.

 
Advanced lightweight cooling-garment technology: functional improvements in thermosensitive patients with multiple sclerosis

Abstract: Cooling of thermosensitive patients with multiple sclerosis (MS) can improve clinical symptoms. In order to study the effectiveness of an advanced lightweight cooling-garment technology based on aquatic evaporation, a single-blinded balanced crossover study was performed on 20 patients with an Expanded Disability Status Scale score 6.5. The results using a tight-cuff cooling-garment prototype for peripheral cooling suggest improvement of a timed-walking test, leg-strength, fine-motor skills and subjective benefits. Preliminary data of the heart rate variability (HRV) including six patients suggest that the MS patients show an abnormal HRV after sham condition, which is normalized after cooling. Technical information was gained about the cooling activity and the practicability and handling of the device. These encouraging findings promote further adaptations of the prototype to increase its cooling properties and ameliorate the practicability of the cooling garment.

 
Predicting beta-interferon failure in relapsing-remitting multiple sclerosis

Abstract: Proposed beta-interferon (IFNbeta) treatment failure criteria for patients with relapsing-remitting multiple sclerosis (RRMS) have not been validated in clinical practice. This study aimed to establish (a) whether IFNbeta attenuated accumulation of fixed disability in comparison to a cohort of matched historical control subjects from the Sylvia Lawry centre for MS research, and (b) whether relapse-based treatment failure criteria or clinical and demographic variables had predictive value for the accumulation of fixed disability.

Of the 175 IFNbeta-treated RRMS patients, 60 (34%) developed accumulation of fixed disability over a median of five years follow-up, which was significantly less than the rate of accumulation of fixed disability in the control group (P<0.0001). Any relapse in the treatment period predicted accumulation of fixed disability with a sensitivity of 80% and specificity of 43%; patients totally relapse free were less likely to develop accumulation of fixed disability (P<0.002).

Multivariate analysis confirmed that a greater risk of accumulation of fixed disability was conferred by a higher Expanded Disability Status Scale (EDSS) score starting IFNbeta (P=0.02), and by failure of IFNbeta to completely suppress relapses (P=0.004). In conclusion, IFNbeta therapy reduced the accumulation of fixed disability in a cohort of RRMS patients, followed for a median of five years. Higher baseline EDSS and failure of complete relapse suppression were associated with a significantly greater likelihood of accumulation of fixed disability.

 
Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study

Abstract:

Objective To analyse transcranial magnetic stimulation (TMS) variables in a prospective six-month follow-up pilot study on patients suffering from relapsing-remitting multiple sclerosis (RRMS), satisfying inclusion criteria for interferon (IFN) beta-1a treatment.

Background So far, no predictive factors are available as to the course of RRMS treated with IFN beta-1a.

Design/methods Fifteen RRMS patients were studied before (month 0 (M0)) and after IFN beta-1a onset (M3, M6). The parameters analysed were motor functional score (mFS), Expanded Disability Status Scale (EDSS), and TMS variables - central motor conduction time (CMCT) and amplitude ratio (AR).

Results Four of the six patients with no motor signs at inclusion, subsequently showed signs of pyramidal dysfunction. All had abnormal M0_TMS variables. The number of M0_TMS abnormalities per patient was greatest in the group that showed mFS worsening, and was significantly correlated with M6_EDSS. The M0_CMCT was significantly correlated with M6_EDSS. During follow-up, the number of patients with abnormal TMS variables decreased from 12/15 to 4/15, and the total number of abnormalities decreased from 33.3 to 16.7%.

Conclusions TMS variables might be predictive of disease progression. The improvement observed here in the TMS variables may reflect an improvement in MS patients undergoing IFN beta treatment.

 
Health-related quality of life in secondary progressive multiple sclerosis

Abstract: Common disability scales in multiple sclerosis (MS) are often weighted towards physical disability. Non-motor symptoms such as depression, fatigue and pain substantially influence wellbeing in MS. Health-related quality of life (HRQoL) measures the broader impact of MS and might indicate less obvious disease burdens. We analysed HRQoL, using the Nottingham Health Profile Part I (NHP-I), among 345 secondary progressive MS (SPMS) patients participating in a randomized trial of interferon-beta1a (IFN-beta1a), 22µg subcutaneously weekly, or matching placebo. The results did not reveal any beneficial effect of IFN-beta1a in any outcome measure. NHP-I sub- and sum scores were compared for 217 population controls and correlated with demographic and clinical disease variables. SPMS patients had lower NHP-I sum and all subscores than the controls. Patients experiencing disease progression reported worse NHP-I sum scores. Increased fatigue, Expanded Disability Status Scale (EDSS) and Arm Index scores were independently associated with reduction in several NHP-I subscores. SPMS patients had significantly lower HRQoL than controls and physical disability (EDSS and Arm Index), disease progression and fatigue strongly influenced this. MS influenced subdimensions such as pain, sleep and emotional reactions. Increased focus on optimizing symptomatic treatment and psychosocial patient care could improve patients' HRQoL.

 
The Effect of Disease, Functional Status, and Relapses on the Utility of People with Multiple Sclerosis in the UK.

Heron Evidence Development Ltd, UK;

Objectives: Because published utility estimates in multiple sclerosis (MS) are concentrated in people with moderate to severe disease severity and focus on specific types of MS, we conducted a cross-sectional study of people with MS to estimate the utility associated with disease, functional status as measured by the Adapted Patient Determined Disease Steps (APDDS) Scale, and relapse to enhance knowledge of the association of these factors and utility.

Conclusions: The results are comparable with previous published utility estimates. We have demonstrated a clear relationship between functional status, disease type, relapse status, duration of illness, and utility. As a set of coefficients, the utility estimates we have calculated may be used to compare the quality of life of people with MS with other illnesses and to inform future economic evaluations in MS.

 

Familial effects on the clinical course of multiple sclerosis.

Department of Clinical Neuroscience, University of Cambridge Clinical School, Addenbrooke's Hospital, UK.

BACKGROUND: Familial factors influence susceptibility to multiple sclerosis (MS) but it is unknown whether there are additional effects on the natural history of the disease.

CONCLUSION: Familial factors do not significantly affect eventual disease severity. However, they increase the probability of a progressive clinical course, either from onset or after a phase of relapsing remitting disease. The familial effect is more likely to reflect genetic than environmental conditions. The results are relevant for counseling patients and have implications for the design of studies seeking to identify factors that influence the natural history of the disease. PMID: 17261686 [PubMed - in process]


 

STANFORD HIRES EMBRYONIC STEM CELL RESEARCH EXPERT

STANFORD, Calif. - The Stanford University School of Medicine has recruited Renee Reijo Pera, PhD, to be the new director of human embryonic stem cell research and education for the Stanford Institute for Stem Cell Biology and Regenerative Medicine.

Reijo Pera, 47, is joining Stanford from the University of California-San Francisco, where she was co-director of the human embryonic stem cell research center and director of the training program funded through the California Institute for Regenerative Medicine. In 2003 she established UCSF's embryonic stem cell program, pulling together faculty with common interests in human embryonic stem cell biology.

Reijo Pera said her new position is a perfect fit for her research interests. "The strength of the research community is tremendous at Stanford," she said, listing the strong human genetics and developmental biology programs, and the school's world-class assisted reproduction clinic. Her work will draw on the strengths of those departments to probe human developmental genetics. "The people and research are amazing."

Her primary appointment will be in the Department of Obstetrics and Gynecology where she will be director of human stem cell research.

Irving Weissman, MD, director of Stanford's stem cell institute, said Reijo Pera is among the leading embryonic stem cell researchers. "She brings a level of sophistication in embryonic stem cell research and the genetics of egg formation that we are excited about having at Stanford," he said. "We expect her to be a leader in our women's health programs."

Weissman said Reijo Pera's experience in establishing an embryonic stem cell program will be an asset to Stanford, where she'll be training scientists in how to work with the finicky cells, deriving new stem cell lines and working to establish collaborations among the school's researchers.

Although she's moving her lab to Stanford, Reijo Pera said she's looking forward to continuing her collaborations with UCSF colleagues. In particular, she has a joint grant with Linda Giudice, MD, PhD, who was a professor of obstetrics and gynecology at Stanford before becoming chair of obstetrics, gynecology and reproductive medicine at UCSF in 2005.

Weissman said that when he heard Reijo Pera might leave UCSF, he called Giudice to let her know Stanford would be among those recruiting her. "I have the greatest respect for Linda Giudice, who led our early efforts at Stanford in setting up our stem cell programs, and I am excited that we will be able to continue our collaborations," he said.

One of Reijo Pera's primary interests is using embryonic stem cells to better understand the very first days of embryonic development. "To me, there is nothing more exciting than the fact that sperm and egg come together to form an embryo," she said.

She has uncovered a timeline of the earliest genes that become active in the human embryo, including those that are required for the development of the germ cells that will eventually produce sperm and eggs. Reijo Pera said this research could lead to a better understanding of infertility and common birth defects. "This is a very exciting time for studies in human developmental genetics that will translate to improvements in current clinical practices, especially in women's health," she said.

In addition to her work understanding early human development, Reijo Pera has led an effort at UCSF to develop new embryonic stem cell lines, and plans to continue this work with Stanford colleagues. A collaboration with Stanford's in vitro fertilization clinic is already under way to develop new stem cell lines from donated embryos.

Weissman said that in addition to Reijo Pera's ongoing work developing new lines from IVF blastocysts, he thinks her work could lead to new avenues of creating embryonic stem cell lines. Her research could reveal ways of differentiating embryonic stem cells into eggs that can eventually be used as an alternative to eggs donated by women.

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Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu.


Thursday

 
Familial effects on the clinical course of multiple sclerosis

Background: Familial factors influence susceptibility to multiple sclerosis (MS) but it is unknown whether there are additional effects on the natural history of the disease.

Method: We evaluated 1,083 families with 2 first-degree relatives with MS for concordance of age at onset, clinical course, and disease severity and investigated transmission patterns of these clinical features in affected parent-child pairs.

Results: There is concordance for age at onset for all families (correlation coefficient 0.14; p < 0.001), as well as for affected siblings (correlation coefficient 0.15; p < 0.001), and affected parent-child pairs (correlation coefficient 0.12; p = 0.03) when each is evaluated separately. Concordance for year of onset is present among affected siblings (correlation coefficient 0.18; p < 0.001) but not the parent-child group (correlation coefficient 0.08; p = 0.15). The clinical course is similar between siblings (kappa 0.12; p < 0.001) but not affected parents and their children (kappa –0.04; p = 0.09). This influence on the natural history is present in all clinical subgroups of relapsing-remitting, and primary and secondary progressive MS, reflecting a familial effect on episodic and progressive phases of the disease. There is no concordance for disease severity within any of the considered family groups (correlation coefficients: all families analyzed together, 0.02, p = 0.53; affected sibling group, 0.02, p = 0.61; affected parent-child group, 0.02, p = 0.69). Furthermore, there are no apparent transmission patterns of any of the investigated clinical features in affected parent–child pairs and no evidence for anticipation or effects of genetic loading.

Conclusion: Familial factors do not significantly affect eventual disease severity. However, they increase the probability of a progressive clinical course, either from onset or after a phase of relapsing remitting disease. The familial effect is more likely to reflect genetic than environmental conditions. The results are relevant for counseling patients and have implications for the design of studies seeking to identify factors that influence the natural history of the disease.

 
WASHINGTON (Reuters): Neurological disease common, survey finds

- Multiple sclerosis, Parkinson's disease and other neurological diseases may be far more common than most people had believed, according to new estimates published on Monday.

Nearly one out of 1,000 Americans has multiple sclerosis or MS and one out of 100 elderly Americans has Parkinson's disease the survey found.

"Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982," said Dr. Deborah Hirtz of the National Institute of Neurological Disorders and Stroke, who led the survey.

It is not clear whether the disease is actually more common or if it is being diagnosed more accurately, she said.

The new survey, published in the journal Neurology, also found the rate of Alzheimer's disease was up substantially from past estimates, with 67 out of 1,000 Americans over the age of 65 affected.

Nearly 10 out of 1,000 older Americans have Parkinson's disease, and four out of every 100,000 has amyotrophic lateral sclerosis, also called ALS or Lou Gehrig's disease, the survey found.

The survey projects that the number of people with Parkinson's will double from about 4.3 million people now to 9 million people worldwide over the next 25 years.

It corroborated other studies on childhood neurological disorders, finding that nearly six out of every 1,000 children has autism, and two out of every 1,000 children has cerebral palsy.

Hirtz and colleagues reviewed studies from nearly 500 medical papers published between 1990 and 2005 for their report.

They found that 101 out of every 100,000 Americans has a traumatic brain injury each year, 50 percent fewer than previous estimates.

More than 180 out of every 100,000 people suffer a stroke each year, and close to five out of every 100,000 have a new spinal cord injury each year.

Steven Albert of the Department of Behavioral and Community Health Sciences at the University of Pittsburgh said the impact of Alzheimer's will be substantial as the population ages.

"Current projections of AD (Alzheimer's disease) suggest that there will be about 10 million cases in the United States in 2050, of which 6 million are expected to have moderate or severe dementia," Albert wrote in a commentary in the journal.

There is currently no cure and treatments only delay the progression of Alzheimer's slightly. There is also no cure for MS or for Parkinson's, although drugs can also delay their progression.


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