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First things first, it needs to be reported the drugs listed in the suit against NovartisPharmaceuticals Corp are Starlix (diabetesmedication) and Lotrel and Valturna (hypertension medications), but Pamela Vaughn of Lima brings up a good question for a later debate:
“What other medications of theirs should be added to this? Gilenya? What I do know,” she stresses. “Is I am not going to stop taking Gilenya; it has been working really well for me.”
Ms. Vaughn has multiple sclerosis (MS) and has been taking Gilenya since the middle of last year.
The U.S. government joined in a suit that was already brought against them by a whistleblower, a former pharmaceutical representative, in 2011.
27 states and 3 major cities (Washington D.C., Chicago and New York) joined the suitciting “illegal kickbacks” and they are seeking triple damages under the Federal False Claims Act.
Taxpayers had to payout millions of dollars in Medicare and Medicaid claims and since doctors received lavish dinners, luxurious vacations and accomplishing very profitable speaking fees just for prescribing these medications, Novartis is looking at what is, so far, civil penalties and unspecified damages.
U.S. Attorney, Preet Bharara stated, “And for its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid and other federal health care programs were left holding the bag.”
With this type of dealing, especially in such an economic climate, it is doubtful many taxpayers are going to be very forgiving about this case. Unless they are like Ms. Vaughn and find their medications are ‘working’ for them.
TUESDAY, April 23 (HealthDay News) -- Atrophy of a key brain area may become a new biomarker to predict the onset of multiple sclerosis, researchers say. If so, that would add to established criteria such as the presence of brain lesions to diagnose the progressive, incurable disorder.
Using special MRI images, scientists from three continents found that the thalamus -- which acts as a "relay center" for nervous-system signals -- had atrophied in nearly 43 percent of patients who had suffered an initial neurological episode that often comes before a multiple sclerosis (MS) diagnosis.
"The telling appearance of lesions, which is a hallmark of the disease, is only part of the pathology," said study author Dr. Robert Zivadinov, director of the Buffalo Neuroimaging Analysis Center at the University of Buffalo, in New York. "Our finding is more related to [initiating] clinical trials, to using thalamic volume as a new biomarker for testing and treatment, and to increasing awareness among investigators that this disease is more than just about lesions."
The study was published online April 23 in the journalRadiology.
Believed to be an autoimmune disorder, MS results in lesions on the brain and spinal cord that disrupt nerve signals to various parts of the body. Symptoms, which can come and go, include numbness, tingling, vision disturbances, problems walking, dizziness, and bowel and bladder problems.
When you experience a multiple sclerosis relapse (also known as an exacerbation or flare-up), it's because new damage in your brain or spinal cord disrupts nerve signals. That's why you might notice new symptoms or the return of old symptoms. A true relapse lasts more than 24 hours and happens at least 30 days after any previous relapses. Relapses vary in length, severity, and symptoms. Over time, your symptoms should improve. Many people recover from their relapses without treatment.
A team of researchers has studied and found no link between stress levels, and the overall risk of developing multiple sclerosis. The study was conducted and led by Trond Riise from the University of Bergen in Norway and focused on data from the Nurses Health Study, specifically nurses between the ages of 24 and 55.
For the purpose of the study, nurses were surveyed, questioned in regards to their levels of stress, what type of stress they have gone through, etc.
They then looked at their medical history, including whether or not they have developed multiple sclerosis. What researchers found was that stress levels had absolutely no impact on the overall risk of developing the disease. This is a major study as it has been long-believed that stress may indeed play a role in the overall risk factor of the disease’s development.
Following this study though, it has been confirmed that stress can certainly be ruled out when looking at multiple sclerosis risk factors.
Researchers stated that they removed all other variables, taking into account varying ages, ethnic backgrounds, etc.
The study has been published in the journal Neurology.
People with multiple sclerosis often turn to alternative medicine to help prevent and manage this chronic disease, according to the results of new research from the University of Copenhagen. Which alternative medicine approaches are multiple sclerosis (MS) patients seeking, and what are the results?
Alternative medicine may help some MS patients
Researchers conducted a study using a questionnaire completed by 3,800 individuals who have MS and who reside in five Scandinavian countries. They discovered that the use of alternative medicine among MS patients has been increasing steadily over the past 15 years.
In fact, more than 50 percent of people in the survey said they used only alternative medicine approaches or used them along with conventional medicine. This compares with 25 percent of Danish people in a previous study who said they had tried one or more different alternative medicine treatments within the past year.
According to Lasse Skovgaard, one of the study’s authors and a PhD candidate from the Faculty of Health and Medical Sciences and the Danish Multiple Sclerosis Society, stressed that “Here, many people with a chronic disease find they benefit from using alternative treatments, so we should not ignore this possibility.”
Based on the study, among patients with MS:
A significantly larger proportion with a high level of education use alternative medicine treatments compared with those with a lower level of education
Individuals with a higher income use alternative medicine more than those with a lower income
Younger women compared with older women are more likely to use alternative medicine treatments
These findings may dispel the idea that only naïve individuals who are looking for a miracle turn to alternative medicine, noted Skovgaard. “Our results indicate that it is primarily the well-educated segment that is subscribing to alternative treatments.”
One hope is that the results of this study will help improve how MS patients and others with chronic illnesses communicate with their healthcare providers and use alternative medicine treatments along with conventional approaches. What are some of those alternative medicine treatments for MS?
Alternative medicine for multiple sclerosis Multiple sclerosis is an autoimmune degenerative disease characterized by the destruction of the myelin sheaths, which are protective coverings on the nerves. The severity of symptoms of MS depends on the degree of damage and which nerves are affected.
Among the alternative medicine approaches taken by MS patients are dietary changes. Although no specific diet has been identified for people with MS, some dietary and supplement modifications have shown some benefit. For example:
Vitamin D. Research indicates that low levels of vitamin D is associated with an increased incidence of MS and that supplementation with the vitamin may protect against its development or relapse. Since few foods are rich sources of vitamin D (e.g., salmon, sardines, mackerel, sun-dried shiitake mushrooms), taking a supplement is recommended.
A dose of 3,000 International Units (IU) of vitamin D per day is suggested. However, individuals should consult their healthcare provider and have a vitamin D test to determine their blood levels of the nutrient.
Gluten. Studies suggest that people with multiple sclerosis are more likely to be intolerant of gluten, a protein found in all forms of wheat and thus have a higher incidence of celiac disease. Therefore, following a gluten-free diet may help some people who have MS.
Following a gluten-free diet can be a challenge, but more and more products are becoming available that do not contain gluten. People with MS can be tested to see if they have a gluten intolerance before they try such a diet.
Low-fat diet. Extensive research by several scientists, especially Dr. Roy Swank, currently a physician at the Health Science Center at the University of Oregon, has shown that individuals with MS who follow a low-fat diet may experience fewer attacks and have a 95 percent chance of not getting worse if the diet is adopted early in the course of the disease. Swank and other advocate a diet that contains about 7 percent fat.
Beyond dietary approaches, there are other alternative medicine options patients with multiple sclerosis may try.
Apr. 23, 2013-- Mayo Clinic and Acorda Therapeutics, Inc. today announced that the first patient has been enrolled in the first clinical trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis (MS). This is a Phase 1 clinical trial enrolling people with MS to assess the safety and tolerability of rHIgM22. The study also includes several exploratory efficacy measures.
In MS, a person’s own immune system destroys myelin, a substance that insulates nerves and facilitates conduction of nerve impulses that control neurological function such as movement and vision. Progressive damage to myelin causes functional impairment in people with MS. Currently there are no approved therapies that stimulate the repair or regrowth of myelin once it has been damaged.
“This remyelinating antibody, if successful in clinical trials and approved, would be a novel approach to treating people with chronic neurologic deficits from multiple sclerosis or other similar conditions,” said Moses Rodriguez, M.D., a neurologist specializing in MS at the Mayo Clinic, whose team initially identified rHIgM22. “We are excited that this Mayo discovery is now being evaluated in people with MS to determine its therapeutic potential.”
“The current standard of MS care does not address the underlying issue of the loss of myelin that leads to progressive functional impairment in people with MS,” said Anthony Caggiano, M.D., Ph.D., Acorda’s Vice President of Research and Development. “Stimulation of remyelination represents a novel and potentially significant advance in the treatment of people with MS, and one which could be complementary to existing therapies. In preclinical studies, rHIgM22 has shown the ability to stimulate production of new myelin and improve function.”
The primary objective of this double-blind, randomized single ascending dose study is to evaluate the safety and tolerability of rHIgM22 in people with MS. The study also includes several exploratory efficacy measures, including magnetic resonance imaging and standard clinical measures used to assess people with MS, such as walking ability. Participants in the trial will receive either placebo or rHIgM22 administered as a single intravenous dose. If rHIgM22 is well tolerated in study groups receiving a low dose of rHIgM22, subsequent groups will receive single infusions of higher doses. Participants in this study will continue receiving their standard MS treatments.
Additional details on this clinical study, including enrollment criteria and contact information for study sites, can be found at:
The remyelinating antibody program is the result of a research collaboration between Acorda and the Mayo Foundation for Medical Education and Research. Acorda licensed worldwide rights to patents and other intellectual property for these antibodies related to nervous system disorders under an exclusive license agreement with the Mayo Clinic in September 2000. Dr. Rodriguez is an employee of Mayo Foundation.
About MS and rHIgM22
Multiple sclerosis (MS) is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin (a process known as demyelination) and eventually the nerve fibers themselves. Myelin is a fatty layer of membranes that insulates nerves, facilitating the transmission of electrical impulses through nerve pathways that control neurological functions such as movement, bowel/bladder function, vision and sexual function.
The cells that make myelin, called oligodendrocytes, can initially repair myelin, but as MS progresses, there is little spontaneous repair. Currently, there are no therapies that repair or restore myelin in demyelinating diseases such as MS. If myelin is able to be repaired it could restore electrical conduction and may serve to protect the exposed nerve fiber from further damage.
Preclinical studies in animal models and laboratory studies have demonstrated rHIgM22 can protect oligodendrocytes (the myelin producing cells) and stimulate them to repair areas of demyelination. rHIgM22 treatment of these animals also resulted in sustained improvements in motor activity.
Take control of your MS symptoms with practical strategies you can use every day.
By Katherine Lee
For the more than 400,000 people in the United States with multiple sclerosis, the disease is often unpredictable. Because symptoms can vary from day to day (you may be feeling too fatigued to even walk out of the house one day, but completely fine the next), living with this progressive autoimmune disorder can be particularly challenging.
But if you rely on a few simple strategies (along with your treatment plan), you can take charge of your disease, says Rosalind Kalb, PhD, vice president of the Professional Resource Center at the National Multiple Sclerosis Society. These 10 tips that can help you manage your MS more effectively.
Chrissy Amphlett, the frontwoman of '90s band The Divinyls, died
at her home in New York City yesterday at the age of 53. She was diagnosed with
breast cancer in 2010, and her musician husband, Charley Drayton, said in a
statement that she "succumbed to the effects of breast cancer and multiple