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Friday, September 21, 2012

Stem Cell Treatment: Beware of Bogus Claims









D
WebMD Feature
Reviewed by Michael W. Smith, MD


Stem Cell Treatments: 6 False-Hope Warning Signs

Unproven, Risky Treatments Mislead Patients to Seek Cutting-Edge Therapy

There's a dark side to stem cells: bogus treatments that prey on patients' hopes when mainstream medicine has little to offer.
Stephen Byer stepped far outside typical medical care when his son, Ben, had ALS. He took Ben to China for stem cell-like treatments, and later helped hundreds of people do the same, believing it would help them.
The unproven procedure could have killed Ben. It didn't -- but it also didn't work. Ben later died of ALS. So did the ALS patients Byer now regrets helping get the treatment.


Why take the chance? For Byer, it started with misleading promises online.


"The Internet, while increasing communication, has spawned a horde of charlatans and creeps," Byer says. "We were suckered into one of the earlier forms of stem cell chicanery."
But not everyone who seeks unapproved stem cell treatments feels ripped off. Even though the stem cell treatments Dawn Gusty got in Tijuana, Mexico, didn't ease her multiple sclerosis, she doesn't look back with regret.
That moment -- when hope surpasses science, and when someone claims to be able to bridge that gap -- may be one of the riskiest for patients to handle. And it's one of the most alarming for stem cell experts.

Hope's Dark Side

"It is a very dangerous situation," says Joshua Hare, MD, director of the Interdisciplinary Stem Cell Institute at the University of Miami.
Make no mistake: Hare is all for scientific stem cell research. His concern, he says, is "hype" that glosses over an inconvenient fact: There are no new approved stem cell therapies.
The danger becomes clear if you Google "stem cell treatment." You'll get search results from clinics in the U.S. and around the world touting stem cell treatments for conditions ranging from baldness to ALS (Lou Gehrig's disease).
People who pursue those treatments "are spending huge sums of money to get therapies that are completely unproven and unlikely to work," Hare says.

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THE NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES PIVOTAL DATA DEMONSTRATING EFFICACY AND SAFETY OF ORAL BG-12 (DIMETHYL FUMARATE) IN MULTIPLE SCLEROSIS


Sept 19, 2012
The New England Journal of Medicine Publishes Pivotal Data Demonstrating Efficacy and Safety of Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis
Results of Phase 3 DEFINE and CONFIRM Studies Support Dimethyl Fumarate's Potential as a Strong Option for MS Treatment
WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec  announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM).

Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease. Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.
"The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy," said Katherine Dawson, M.D., senior medical director, Biogen Idec Neurology Research and Development and Biogen Idec lead author on both dimethyl fumarate manuscripts in NEJM. "The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible."
DEFINE and CONFIRM Efficacy Results
Together, the DEFINE and CONFIRM manuscripts in NEJM summarize the positive Phase 3 clinical data set for dimethyl fumarate, which formed the foundation for its regulatory filings around the world.
DEFINE was a two-year global study that evaluated dimethyl fumarate (240 mg, BID or TID) compared to placebo in people with RRMS. Results showed that both dimethyl fumarate BID and TID met the study's primary endpoint by significantly reducing the proportion of patients who relapsed by 49 percent and 50 percent (p<0.0001 for both; reported in NEJM as <0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, at two years compared to placebo. Both dosing regimens also met all secondary endpoints in the study.



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Thursday, September 20, 2012

Financial Planning webinar from the National MS Society


The National MS Society
and MS Learn Online invite you to view.. 


Featuring: Silvia Stazzio, CFP

It's never too early to begin planning financially for the future. This is especially true if you are living with MS. Evaluating your income, assets, debts, benefits and other resources is essential for being well prepared for your future. Join us as we discuss financial planning for people with MS. Sylvia is a certified financial planner and serves as chair of the Financial Education Partners Program for the Washington DC Chapter of the Society of Financial Professionals. They work with the National MS Society to provide pro bono counseling to chapters of the National MS Society. 

 Click here to view the webcast, 
or copy into your browser:http://www.nationalmssociety.org/multimedia-library/ms-learn-online/index.aspx   




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Wednesday, September 19, 2012

Another Experimental MS Pill Continues to Show Promise


WebMD Medical News
Reviewed by Louise Chang, MD

Sept. 19, 2012 -- An experimental pill is showing promise for the treatment of multiple sclerosis.

In two late-phase studies appearing in The New England Journal of Medicine, the drug BG-12 (dimethyl fumarate) reduced relapses by about half in patients with the most common form of MS.

If approved by the FDA, BG-12, which is being developed by drug maker Biogen Idec, will become the third oral drug for people with multiple sclerosis.

The second -- Sanofi Aventis’ pill Aubagio -- won FDA approval just last week.

“This is an exciting time in the development of new drugs for MS, especially considering the fact that we had no effective treatments just a few decades ago,” says National MS Society Chief Research Officer Timothy Coetzee, PhD.

BG-12 Reduced Relapses, Lesions

Multiple sclerosis is a chronic disease in which the immune system attacks the insulation that coats and protects nerve fibers of the brain and spinal cord.

With the most common type, people experience sporadic attacks or flare-ups of symptoms that are then followed by periods of remission. Symptoms include numbness, fatiguevision problems, spasms, and issues with bladder and bowel control.

People with this "relapsing-remitting" form of MS were the target group for the new oral drug.
The two newly published trials were funded by the drug’s manufacturer.

In one, patients with relapsing-remitting disease who took BG-12 twice a day had a 44% reduction in relapses over two years of treatment. In the second study, the relapse reduction over the same period was 53%.

The most common side effects associated with treatment were flushing and stomach issues such as diarrhea andabdominal pain. But most patients experienced fewer of these events after the first month of treatment.

Twice-daily treatment was also linked to a 71% reduction in new brain lesions associated with MS in one of the studies, led by neurologist Robert J. Fox, MD, who runs the Cleveland Clinic Mellen Center for Multiple Sclerosis.

Fox has served as a paid Biogen Idec consultant for projects unrelated to the BG-12 study.
“In my opinion, BG-12 offers a very strong combination of (effectiveness), safety, and tolerability,” he says.



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Tuesday, September 18, 2012

Alternative Treatment Options


Many people with MS use complementary and alternative medicine (CAM), which refers to unconventional medical practices that are not part of mainstream medicine. The term complementary medicine refers to therapies that are used in addition to conventional medicine, while the term alternative medicine is used to describe treatment that is used instead of conventional medicine.

Surveys have shown that approximately 90% of people who use CAM also use conventional medicine. Thus, a small fraction of people who use CAM do so in a truly alternative manner.
One of the biggest testaments to the appeal of CAM is that approximately 85 million people have paid for it, out of their own pockets, to the tune of $10 billion a year. Studies reveal that at least one out of three people in the United States has tried CAM and a majority of physicians supports the use of one or more CAM therapies. Currently two-thirds of health maintenance organizations (HMO’s) offer some CAM to their members.

The fact that over 125 medical schools, including Harvard, Albert Einstein College, Cornell, Duke University, Stanford University School of Medicine, now offer CAM to their patients, has eased the minds of many who once felt all doctors were highly opposed to alternative medicine.

While methods of conventional medicine provide the greatest hope for understanding and curing MS, there are three areas of CAM that may be of interest to people with MS because conventional medicine does not, as of yet, have a cure:

  • Health and Well Being – diet, exercise, herbs, vitamins, apitherapy, hyperbaric oxygen
  • Stress - massage, reflexology, meditation, guided imagery, biofeedback, tai chi, yoga
  • Symptom Management - acupuncture, ayurveda, homeopathy, chiropractic

With a large number of people with MS pursuing CAM therapies, it is essential for people to be knowledgeable about the therapies they choose and for physicians, other healthcare providers, and CAM practitioners to be aware that multiple conventional and CAM therapies are in use and that interactions among them are possible.

By focusing more attention on CAM, and increasing communication between patients and healthcare professionals, we may actually develop a new understanding of the disease process, perhaps even discovering new therapies

(Last reviewed 7/2009) - MSF


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Living with multiple sclerosis means struggles and triumphs



(CNN) -- It started in May of last year for Beth Ulibarri, as she would go on the occasional long run.

"I would experience a tingling sensation throughout my lower legs. I described it as feeling like something was tickling my legs from the inside and just figured it was my muscles firing away from the exertion of the run."

Less than a year and many medical tests later, the Albuquerque, New Mexico, resident was diagnosed with multiple sclerosis, or MS.

"My biggest struggle has been dealing with the unknown -- questions that do not have answers," she said. "Concern for my children -- will they get this disease as well? Concern for my future. Will I end up in a wheelchair? Concern for how my husband will handle everything to come."

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CCSVI Studies, continue


Sep 04, 2012
Seven research projects investigating CCSVI (Chronic Cerebrospinal Venous Insufficiency) and MS -- launched with a $2.4 million investment by the National MS Society and the MS Society of Canada -- have reached the two-year milepost.

The funded multi-disciplined researchers have been reporting significant progress in their two-year study goals. As of July 2012, most of the investigators are in the process of completing their projects and expect to do so within the next year. Even though the work continues for several of the teams, some are already presenting preliminary results at medical meetings, and all have shared technical advice so that the projects can move forward as smoothly and quickly as possible.
The need for continued work beyond the two-year grant funding period is not uncommon, as practical and logistical issues begin impacting on projected timelines, including such items as:
• getting proper protocols in place;
• applying for and gaining approvals from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a first step established by regulatory authorities to protect human subjects involved in research projects;
• getting technicians and other team members trained on how to conduct appropriate screenings; and
• recruiting study participants.
After the research projects are completed, the studies will be analyzed and submitted for publication in one or more scientific journals so that peers can evaluate and comment on the findings. Currently it is not yet known when the full data and results will be available, though updates will continue as appropriate to reflect the ongoing transparency of the work being supported by the U.S and Canadian MS Societies. Results from the seven projects, as well as other studies underway around the globe, will help guide our planning for future investments in this area of research.

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Aubagio, a once a day pill for MS, Now FDA Approved


The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”


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Monday, September 17, 2012

Added benefit of Cannabis sativa for spasticity due to multiple sclerosis is not proven


Manufacturer deviates from the appropriate comparator therapy of the G-BA

An extract from the plant Cannabis sativa (trade name Sativex®) was approved in May 2011 for patients suffering from moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS). In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new drug, which is used as a mouth spray, offers an added benefit over the optimized standard therapy. However, no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.

Comparison of different possibilities for optimizing treatment
The extract from Cannabis sativa, which contains the active ingredient combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), is approved as add-on therapy to the already used antispastic drugs. Usually, drugs such as baclofen or tizanidine are given to treat muscle spasms. The cannabis extract can be considered when, despite an individual, patient-tailored use of these drugs, the symptoms caused by spasticity cannot be adequately relieved.

The G-BA specified an optimized standard therapy containing baclofen, tizanidine or drugs that are approved for the treatment of spasticity in underlying neurological diseases as the appropriate comparator therapy. At least two previous attempts at treatment were to have been made, in each of which different oral antispastic (spasmolytic) drugs had been used in an optimum way. Again, at least one product was to have contained the active ingredients baclofen or tizanidine. The aim of the assessment by IQWiG was to compare the additional administration of the Cannabis sativa extract with other available possibilities for optimizing treatment and to assess the added benefit.

Optimization of premedication was not planned in any of the studies
However the manufacturer deviated from this specification of the G-BA, without providing adequate justification for doing so. In its dossier, the manufacturer drew no conclusions about the extent and probability of the added benefit compared to the appropriate comparator therapy specified by the G-BA. The studies submitted by the manufacturer were not suitable for reaching conclusions on added benefit in comparison with an optimized standard therapy. This was because in none of these studies was it planned to optimize the antispastic premedication. Instead, this treatment was to be continued unchanged. Therefore there is no proof from the manufacturer's dossier of an added benefit of Cannabis sativa extract compared to the appropriate comparator therapy of the G-BA.

G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
An overview of the results of the benefit assessment by IQWiG is given by an English-language extract. You can also find easily understandable and brief German-language information on the website gesundheitsinformation.de, published by IQWiG.
The G-BA website contains general English-language information about the procedure of benefit assessments pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of Cannabis sativa.

source press release found here
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Multiple sclerosis patients, doctors appreciate help from Ann Romney, Michelle Obama

Caroline Holloway, an MS patient from Largo, goes through an arm strength assessment by Dr. Stanley Krolczyk, director of the Multiple Sclerosis Division of the Department of Neurology at USF Health in Tampa, during one of her regularly scheduled visits.
Caroline Holloway, an MS patient from Largo, goes through an arm strength assessment by Dr. Stanley Krolczyk, director of the Multiple Sclerosis Division of the Department of Neurology at USF Health in Tampa, during one of her regularly scheduled visits.
[SKIP O’ROURKE | Times]
Regardless of your political leanings, at least one group of Americans was grateful for the Republican and Democratic National Conventions: Those affected by MS.

People with multiple sclerosis appreciated the shout-out from Ann Romney, wife of presidential nominee Mitt Romney, at the Republican National Convention in Tampa and from first lady Michelle Obama with the Democrats a week later in Charlotte, N.C
Romney has been living with MS since 1998. Obama's father lived with the disease for about 30 years before his death at age 66. Both women related how their lives were affected by MS.
That kind of exposure does more than increase awareness of an often misunderstood disease that afflicts 400,000 Americans, experts said.
"In the case of Ann Romney, seeing someone at the podium, in the national spotlight, living an obviously busy, active life allows others to see how much you can accomplish with MS," said Dr. Stanley Krolczyk, director of the multiple sclerosis division in the department of neurology at USF Health. "It puts a different face on the disease when celebrities, like Montel Williams and Clay Walker, for example, go public and talk about living with MS."
Jzon Livingston Sr., a patient of Krolczyk's, agrees. The 33-year-old self-employed IT administrator was diagnosed with MS four years ago. With treatment, he's been able to continue working and keep up with his three children, ages 15, 13 and 11. Livingston was moved when Obama described watching the decline in her father.
"That's what the average person needs to know about MS. It's a hard disease to have," he said. "Without knowledge of how it can affect lives, there's no understanding. Without understanding, there's no action.
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