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Saturday, April 24, 2010

Finally - TODAY - The 2010 MS Getty

It happened and now it's over for at least another year



written April 24, 2010 by Stuart Schlossman

TODAY is the Big day. The event that I have been working on for the last 4+ months will be taking place late this afternoon, into the evening. We are expecting approximately ( 300 ) people. A full house or backyard in t his case and the weather is almost perfect.

Attending will be several neurologists, coming, in respect for a colleague who will be recognized and honored by "MS Views and News" for his 40+ years devoted to the MS community.

Speaking will be two neurologists on matters of importance to many patients. Included will be current treatment updates, such as Ampyra, the oral medications on the near horizon, Stem Cell therapy and CCSVI (chronic cerebral venous insufficiency). A Q&A will follow and then we will begin the recognition of William Sheremata, MD. -

Dr. Sheremata has a CV ( a resume) in excess of 30 pages, documenting all the research, books and ms community activities that he has been part of since the late 1960's.

He deserves this honor and I / MSV&N will give this to him.

All the stress of the last few weeks/months will soon culminate and maybe I will be able to sleep a full night, this evening.

But first let me know get back to my (hopeful) last stress task for this event, the writing of my script.....

Have a great day.

Zamboni's CCSVI theory backed up by Swank's research

Information provide by Gregg L. -- thanks Gregg

Professor Roy Laver Swank was a pioneer in MS research. His successful treatment of 144 people with MS with a low saturated fat diet over 34 years was a breakthrough in MS management, and should have been acknowledged as such by his peers, and taken up by the profession. But on reading his 'Multiple Sclerosis Diet Book', a startling fact emerges. Swank appears to have predicted the work of Zamboni in his Chronic Cerebro-Spinal Venous Insufficiency (CCSVI) hypothesis of MS causation. Not only did he develop the treatment for the disease, but he may have found the cause as well.


On p81 of his book, Swank says: "...the frequent location of the pathological lesions (plaques, or areas of demyelination) in the brain and spinal cord surrounding small venous channels, suggest that the small blood vessels (microcirculation), which includes the arterioles, capillaries and venules, play a role in the genesis of this disease. This contention has been supported by the observations that small arterioles and venules of the brain and spinal cord are thickened, often tortuous, nodular, and alternately constricted and dilated...."


On p84 Swank states that "...Recent study of the cerebral blood flow (CBF)......revealed significant reduction of the flow in the MS patients. ...In patients with MS, there was a progressive, generalized decrease in CBF....The rates of decrease were significantly greater than in normals, and they correlated directly with the speed of progress of the disease."


But Swank took things further than Zamboni. He postulated a cause for these small blood vessel obstructions and decrease in blood flow: on p86 he says: "A search for a mechanism that could cause both an interference with, and slowing down of, the cerebral... blood flow, and breakdown of the blood-brain barrier in the central nervous system, leads to a consideration of the circulatory changes that have been observed in a number of species, including man, following large saturated fat meals." And of course he followed this up with an intervention trial, where he gave people with MS a low saturated fat diet, with startling results.


It is extraordinary that we in the medical profession have ignored Swank's work for so long. In hindsight, not only did he develop his theories from basic observational epidemiological studies, as we do today, but he did laboratory work to confirm the likely causes of circulatory problems in MS, and then actually showed that changing the diet from saturated to unsaturated fats stopped disease progression.


Today, we accept that saturated fat causes many of the circulatory diseases in Western society, including heart disease, peripheral vascular disease, stroke, and so on. These diseases are characterised by narrowing of vessels and reduced blood flow. Zamboni's contribution has been to focus us again on this mechanism in MS, like the others, a typically Western disease. As with the other diseases, Zamboni's work suggests that once the damage is done, opening up the narrowed vessels surgically provides temporary relief; but Swank's lifelong research makes us realise that, in all probability, if we wish to make a real difference long term, dramatic dietary changes are necessary.


Once again, we in the MS community have reason to celebrate the amazing genius of Professor Roy Laver Swank.




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Thursday, April 22, 2010

"I second this" : MS patients report improvements in quality of life, reduced fatigue and improved cognition

MS patients report improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI

In this ongoing one-year longitudinal study, patients with MS were asked to assess their outcomes using validated patient-reported outcome measures prior to treatment initiation and after the third, sixth and 12th infusions with TYSABRI. The posters presented at AAN show that patients reported significant improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI.

One of the posters on this study, Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. Another titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. A third titled Improvement in Patient-Reported Fatigue and Cognitive Function over Time with Natalizumab Treatment (P06.167) will be available for viewing on April 15 from 3 - 7:30 p.m. EDT.



Read more: http://www.drugs.com/clinical_trials/large-body-data-tysabri-presented-annual-meeting-american-academy-neurology-9150.html#ixzz0ls7SgU00


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Wednesday, April 21, 2010

Sustained improvement in physical function and Quality of Life when using Tysabri

April 2010
Below - find some of what was discussed concerning Tysabri at the recent AAN meetings in Toronto.

Beneath these reviews, find the link to read the complete article.
Source: Drugs.com

Sustained improvement in physical function, as measured on the EDSS scale, was associated with improved quality of life for patients with relapsing MS taking TYSABRI

This study evaluated the relationship between sustained changes in disability, as measured by the Expanded Disability Status Scale (EDSS), and changes in patient-reported quality of life in TYSABRI patients. Disability improvement may be associated with improvements in patient-reported outcomes.

This analysis showed that sustained improvement in physician-rated EDSS scores was associated with sustained improvement in patient-reported QoL, including physical and mental components of QoL (as measured by Physical Component Summary, PCS, [p 0.0001] p="0.0250]" -

The poster, Improvement in EDSS Corresponds with Improvement in Quality of Life in Patients with Multiple Sclerosis (P02.169), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT.

MS patients report improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI

In this ongoing one-year longitudinal study, patients with MS were asked to assess their outcomes using validated patient-reported outcome measures prior to treatment initiation and after the third, sixth and 12th infusions with TYSABRI. The posters presented at AAN show that patients reported significant improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI.

One of the posters on this study, Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. Another titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. A third titled Improvement in Patient-Reported Fatigue and Cognitive Function over Time with Natalizumab Treatment (P06.167) will be available for viewing on April 15 from 3 - 7:30 p.m. EDT.

AAN platform presentation shows MS patients treated with TYSABRI experienced no substantial changes in the presence of JCV DNA, and second platform shows that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of antibodies to JCV that suggests prior infection

One platform presents data suggesting that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients. In the Dose Suspension Safety Assessment (n=1397) and STRATA (n=1094), JCV DNA was detected in less than 1 percent of all patients, approximately 50 percent of whom were TYSABRI naïve.

The second platform presents data indicating that patients who developed PML had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Investigators evaluated serum samples from TYSABRI patients who developed PML where blood samples had been collected at least one year prior to the diagnosis of PML. Most of these samples were collected prior to beginning treatment with TYSABRI. In all of these patients, serum samples were positive for JCV antibodies prior to onset of PML, suggesting pre-existing JCV infection in these patients. Additional analyses are needed to determine whether anti-JCV antibodies are useful in stratifying for PML risk.

The first platform presentation, Effects of Natalizumab Treatment on the Presence of JC Virus DNA in Blood or Urine in Multiple Sclerosis Patients (S31.002), is on April 14 during the session from 4:15 - 5:30 p.m. EDT, and the second, Evaluation of the Incidence of Anti-JCV Antibodies in a Cohort of Natalizumab-Treated MS Patients (S31.003), is on April 14 during the session from 4:15 - 5:30 p.m. EDT.



Read more: http://www.drugs.com/clinical_trials/large-body-data-tysabri-presented-annual-meeting-american-academy-neurology-9150.html#ixzz0lmQklyzy


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AAN: No Pregnancy Issues in Early Natalizumab Review


By Ed Susman, Contributing Writer, MedPage Today
Published: April 13, 2010
Reviewed by Ari Green, MD; Assistant Professor, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
SOURCE: Medpage today

TORONTO -- An early check of registry data from women with multiple sclerosis who became pregnant while taking natalizumab (Tysabri) does not appear to raise concerns of miscarriages or abnormalities, researchers said here.

"We have to emphasize that these are preliminary findings," said Lynda Cristiano, MD, medical director of drug safety at Biogen Idec, Cambridge, Mass., who presented data at a poster presentation at the annual meeting of the American Academy of Neurology.

The prospective Tysabri Pregnancy Exposure Registry has enrolled 179 women, of whom 125 have completed outcomes as of Nov. 23, 2009, Cristiano said.

She said 20 miscarriages occurred among those 125 outcomes -- about 16%, similar to the estimated 15% rate reported in the general population, according to the March of Dimes. Six other women elected to terminate their pregnancies. No ectopic pregnancies or stillbirths were recorded.

Of the 99 live births, 78 of the pregnancies were full term, Cristiano reported. Eight malformations were reported in six pregnancies -- two which involved twin births. The average maternal age in these cases was 29 years.

"As this is an internal and preliminary analysis, birth defects have not yet been classified as major or minor," she said.

"In addition, the sample size of enrolled patients is small and has limited power to detect an increased risk of major birth defects." For those reasons, Cristiano said the rate of birth defects was not calculated for her report.

However, she said the cases have no patterns related to the disease-modifying drug.

The registry data reflect the fact that about two-thirds of patients with multiple sclerosis are women, and that the average age of onset of multiple sclerosis coincides with childbearing years. Therefore, disease-modifying agents such as natalizumab are likely to be used by women of childbearing age, Cristiano noted.

Of the 64,600 patients who were exposed to natalizumab through December 2009, about 73% were women, and their average age was 44 years.

"There are no adequate and well-controlled studies of natalizumab in pregnant women," she said.

Animal studies suggested treatment with natalizumab might have adverse impacts on fetal outcomes.

"Doctors tell their patients who are going on disease modifying therapy that none of these drugs are approved for women who are pregnant," said Rosalind Kalb, PhD, vice-president of the professional resource center of the New York-based National MS Society.

"This registry and those that were established for the interferon therapies are designed to capture information on outcomes of women who become pregnant by accident while they are taking these drugs," she explained.

Kalb said registries are the only way to determine safety of these drugs because controlled clinical trials are unlikely to be conducted.

She said the preliminary results presented at AAN do not raise alarms, but don't prove natalizumab is safe for pregnant women, either.

Cristiano is an employee of Biogen Idec. Kalb has no financial disclosures.


Primary source: American Academy of Neurology
Source reference:
Cristiano L, et al "Preliminary evaluation of pregnancy outcomes from the TYSABRI (Natalizumab) pregnancy exposure registry" AAN 2010; Abstract P01.185



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Blog Postings from MS About.com on CCSVI, and Copaxone

From Julie Stachowiak, Ph.D., your Guide to Multiple Sclerosis
With all of the emotions swirling around CCSVI and MS, I was pretty curious to hear what the scientists who developed this theory had to say in the web forum last week (co-sponsored by the National MS Society and American Academy of Neurology). I got the impression that they are a little nervous about the response among MS patients out here in the world. While many people are simply asking to be tested, many others are going ahead and seeking treatment.

I was happy to hear that the conflict between the urgency felt by people with MS and the scientific desire for methodical thoroughness was acknowledged. One of my favorite ideas to date is the establishment of a registry of patients undergoing CCSVI treatment and testing, as this would provide at least some information as to what is going on across the globe, as well as some data in terms of patient outcomes. Seems like a good compromise to me. We'll keep watching this one. Take care of yourselves, my friends.


Scientists Call for Ethical Consciousness Around CCSVI Treatment and Research
In a live web forum entitled, "What Do We Know About CCSVI?" sponsored by the National Multiple Sclerosis Society (NMSS) and the American Academy of Neurology on April 14th, people with MS were able to join researchers and journalists in hearing about chronic cerebrospinal insufficiency (CCSVI) and multiple sclerosis straight from the people who developed the theory and conducted initial research around the MS-CCSVI link. Read more...

Copaxone Still an Option for Many
This is "news" from the meeting of the American Academy of Neurology last week. Basically, research shows that people who switch from interferons to Copaxone (either because of side effects or ineffectiveness) seem to do pretty well on Copaxone. I thought we already knew this was an option, but interesting to see it presented formally here. Read more...




Tuesday, April 20, 2010

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Early Line Dominance of Teva's Copaxone and Biogen Idec's Avonex in the Treatment of Multiple Sclerosis


Early Line Dominance of Teva's Copaxone and Biogen Idec's Avonex in the Treatment of Multiple Sclerosis To Diminish Following the Launch of Oral Disease-Modifying Therapies


WALTHAM, Mass., April 19/PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that early lines of therapy for the treatment of multiple sclerosis are dominated by Teva's Copaxone and Biogen Idec's Avonex, an interferon-beta (IFN-beta) agent. According to surveyed neurologists, Copaxone's superior side-effect profile, particularly the lack of flu-like symptoms, is a key driver of its first-line use. For Avonex, lower frequency of injection-site reactions and weekly dosing are advantages surveyed neurologists say are driving its early line use. However, the new report entitled Treatment Algorithms in Multiple Sclerosis also finds that some use of these agents will shift to later lines of therapy following the anticipated launch of oral disease-modifying therapies for the treatment of multiple sclerosis.

According to the report, 48 and 43 percent of surveyed neurologists expect to decrease their first-line use of Copaxone and Avonex, respectively, by 2012, while 45 and 38 percent of respondents expect to increase their third-line use of each respective therapy. Meanwhile, approximately half of surveyed neurologists do not expect to adjust their prescribing of Copaxone, Avonex or any other IFN-beta therapies in any line of treatment over the next two years.

"While the launch of the first oral disease-modifying therapies will no doubt be a transformative event in the treatment landscape for multiple sclerosis, many surveyed neurologists say they do not expect to change their prescribing habits over the next two years, which demonstrates how entrenched Copaxone, Avonex and the other IFN-beta therapies are in the treatment algorithm for multiple sclerosis," said Decision Resources Therapeutic Area Director Bethany Kiernan, Ph.D. "The fact that the prescribing trend is similar for Copaxone and all of the IFN-beta agents suggests there is little differentiation in the minds of neurologists in the suitability of these agents for use in early lines of therapy, making it critical for product marketers to emphasize the advantages their product offers to capture and defend market share."

READ MORE



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Monday, April 19, 2010

An MS Patient's Frustrations and Concerns, while feeling left behind

The Testimonial found below was recently sent to me by an MS Peer who wanted to vent. After she sent this to me, I asked her permission to post it, so that we can get reaction and response from others who feel the same (as she) or want to provide other feedback. Her acknowledgement to have it printed on this blog is shown below her featured writing.

Subject: where do we go from here?

Hi Stu,

I have been getting your newsletter for sometime and I read it thoroughly.
I feel like I am being left behind as others in my stage of this illness.

I feel like there is a political agenda that is outlining how I am supposed to act and feel about the fact that there is no more treatment options for those like myself who have been on different meds over the years and have been on Novantrone in particular and have now been told there simply is no current treatment options for you.

I feel angry about the lack of not only interest in this part of the MS Community but also feel like there is a total lack of concern in helping people once they have exhausted current meds and have what they classify as Secondary Progressive.

It is like Oh Well, to bad but there is nothing for you at this time, so just accept the fact that you are getting worse, things are more difficult and live with it.

Be upbeat about the fact that the medical community has nothing to offer. We want you to have a positive outlook though so we can continue to help those who are in the early stages of this illness.

I CANNOT ACCEPT THIS , I WONDER IF WE TOLD ALL THOSE PEOPLE IN THE MS COMMUNITY OF PROFESSIONALS, TO JUST ACCEPT THAT THERE IS NO HELP FOR YOU, HOW THEY WOULD REACT?

Not to long ago at least in my generation, there was a disease that turned the world upside down, AIDS, If we look back to where it began and how far they have come in relatively a few short years, in comparison to MS, they have managed to harness the disease that is no longer killing or disabling people. IT IS BEING MANAGED WITH EFFECTIVE MEDICATIONS. HIV DIAGNOSIS IS NO LONGER A DEATH SENTENCE.

I feel betrayed by the MS Community, we lack not only effective medications to stop the progression, but we lack services to help with the care of those afflicted and losing their mobility and the ability to maintain their indepedence.

What is to become of those people if they are Single and Sick?

We resemble the AIDS community in that respect that a large number of MS is SINGLE and living alone. No family to help.

So yes I am angry about the press constantly telling us what new things the researchers are looking at.

I have had a MS Diagnosis for 20 years. I AM NOT NEW TO THIS. What I AM NEW TO, IS the fact that I am now at the end of the line for effective treatment options, and that the attitude is ,sorry but there is nothing for you at this time.


I feel those of us facing this point need to have a voice. We need to be heard not brushed aside.


IT IS NOT OK. IT IS NOT ACCEPTABLE AFTER 20 YEARS IN MY TIME THAT WE ARE NOT ANY FURTHER ALONG WITH PROVIDING MEDICATIONS THAT ACTUALLY STOP THIS DISESE FROM PROGRESSING.


THE DIFFERENC IN THE AIDS COMMUNITY AND THE MS COMMUNITY. IS, THEY DID NOT ACCEPT THE INFERIOR PROGRESS THAT WAS BEING MADE.


THEY WERE LOUD AND VISIBLE AND NOT ACCEPTING THE DEATH SENTENCE. THEY SIMPLY DEMANDED RESULTS. AND THEY WERE VISIBLE AND NOT GOING OT HIDE IN A CORNER AND ACCEPT THE ILLNESS.


IT IS UP TO US TO SAY THIS IS NOT ENOUGH! IT IS NOT OK.

WE ARE BEING LED DOWN A ROAD OF SUBMISSON, AND LURED INTO ACCEPTING THAT THE MEDICATIONS ARE SLOWING THE DISEASE PROCESS.


WE NEED TO DEMAND MORE. SLOWING IS NOT ENOUGH! NOT AFTER 20 YEARS. NO.
I WILL NOT BE PRAISING THE MS COMMUNITY FOR A JOB WELL DONE, NOT UNITL THEY STOP THE PROGRESSION.


WE NEED TO SAY AS A COMMUNITY, IT IS NOT ENOUGH!


Thank you Stu for your diligent work in sharing this newsletter with us.

I hope you understand my views. Although not politically correct with that of the MS Community


Sincerely,
Felicia J

Here was Felicia's response:
I guess it would be OK, especially if it inspires others to respond and I will look to see how others respond.
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Sunday, April 18, 2010

MS-Related Fatigue Responds to Immunodulator (Copaxone)


By Ed Susman, Contributing Writer, MedPage Today
Published: April 17, 2010
Reviewed by
Ari Green, MD; Assistant Professor, University of California, San Francisco.


TORONTO -- Multiple sclerosis patients treated with glatiramer acetate (Copaxone) reported a trend to lessening of the fatigue caused by the disease, researchers said here at the annual meeting of the American Academy of Neurology.

After six months, 59.1% of the patients given the immunomodulator had experienced an improvement of fatigue severity as measured with the total Modified Fatigue Impact Scale score compared with baseline, Norman Putzki, MD, of the Klinik fur Neurologie und Neurophysiologie in St. Gallen, Switzerland, and colleagues reported.

"Fatigue is one of the most frequent and most debilitating symptoms of multiple sclerosis," Putzki and his noted in their poster presentation. "Its origin is poorly understood, but immunologic mechanisms may play a role."

The researchers scrutinized outcomes with glatiramer acetate because the drug is thought to modulate T-cell activation. Glatiramer acetate is also believed to favorably impact the Th1 to Th2 ratio -- the subsets of T cells that produce different cytokine activity, which characterizes different immunologic responses.

However, other recent work also suggests that GA may exhibit its primary clinical effect via modulation of antigen presentation on monocytes and B cells and not by changing T cell activity.

Putzki and colleagues enrolled 29 patients diagnosed with the remitting-relapsing form of multiple sclerosis. They had been diagnosed for a mean of 34 months and their mean Expanded Disability Status Scale score was 2.2 -- indicating minimal to mild disability.

These patients -- 20 of whom were women -- were naïve to multiple sclerosis treatment when they were started on glatiramer acetate. Their scores on the Modified Fatigue Impact Scale at baseline were compared with similar scores at the end of six months in this prospective, observational study.

"The majority of patients who initiate GA experience a mild decrease of fatigue severity while fatigue worsening is rare," Putzki reported.

The mean scores of the physical subscore of the scale showed a tendency to decrease from baseline to month 6 while the other subscores and the total scores did not show significant changes during the investigational period.

Mean Functional System Scores decreased from 4.4 to 4.1 (P=0.06).

Only a few patients scored worse six months after treatment initiation with glatiramer acetate, the researchers reported.

A limitation of the study is that it is difficult to draw definitive conclusions from very small open label trials such as this one.

The study was supported by Teva, Germany.

Putzki disclosed financial relationships with Biogen Idec, Merck Serono, Schering, Teva Neuroscience, sanofi-aventis, Allegan, Ipsen and Novartis. Other authors disclosed financial relationships with Antisense Therapeutics, Bayer, GlaxoSmithKline and Pfizer.


Primary source: Neurology (Supplement) 2010 Annual Meeting Program

Source reference:
Nowack M, et al, "Course of Multiple Sclerosis Associated Fatigue during Treatment with Glatiramer Acetate," [P05.055]Neurology 74, March 5, 2010 (Suppl 2) p. A421.


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