U.S. health regulators said on Tuesday they received a report of a multiple sclerosis patient who died within 24 hours of taking the first dose of Novartis AG’s Gilenya.

SUMMARY

The patient, who had been suffering from multiple sclerosis for over 10 years, died on November 23, one day after receiving his first dose of Gilenya, Novartis said.

The U.S. Food and Drug Administration said at this time, it cannot conclude whether the drug, a potential blockbuster, resulted in the patient’s death, but was evaluating the case.

The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.

Last week, the Swiss drugmaker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug.

The patient, who had been suffering from multiple sclerosis for over 10 years, died on November 23, one day after receiving his first dose of Gilenya, Novartis said.

The FDA said healthcare professionals should observe all patients for signs and symptoms of slow heart rate for 6 hours after the first dose of Gilenya.

However, the regulator said it believes Gilenya provides an important health benefit when used as directed, and patients with multiple sclerosis should not stop taking the drug without talking to their healthcare professional.

What besides throat cancer cause sore throat, some pain, sometimes problems swallowing for longer than 3 months? I don't think I had temperature during that period ether.

Well first a sore throat can be caused by so many things its impossible to name them all and keep the answer fairly short. As for swallowing difficulties, there are a few things besides cancer that can cause this and they can be grouped into two categories Neurological i.e: Stroke, Parkinsons, Multiple Sclerosis, or Muscular i.e: Muscular Distrophy, Myasthenia Gravis. The best thing is to see your doctor so s/he can order the appropriate tests, like a Modified Barium Swallow eval.

Is there any difference..? Or is it the same thing? Also, wondering what the symptoms are..do you KNOW when you've gone insane or have dementia? Because I think I just came down with a case of the "crazies" myself..;s

That is interesting because I'm starting to doubt whether there is a difference between a lot of things myself.

After reading about a disease called Multiple Sclerosis, which can also cause memory loss, (temporary) loss of motor control and a number of other symptoms that are also coherent with for instance insanity and dementia, but also with parkinson's and alzheimer's disease.

So now I'm wondering how many times an actual correct diagnosis is made and what really causes a malfonction in the body.

My wife sometimes feels like she's going crazy. she had 2 kids and hormones do have a big influence on the body. At night when she finally sits down to rest she gets the symptoms. in her case it was a vitamin B12 deficiency in the blood. so she had some vitamin supplements and steel tablets and the symptoms were gone.

So I'd say: go see a doctor and get an elaborate blood test done before you conclude that you're going insane.

not much

dementia is an older term, not well defined, except in the case of 'senile dementia"

and insanity isn't defined real well.
There is the legal definition ( can you tell right from wrong? can you assist your lawyer in defending you)

we can give good definitions to specific forms of insanity -
sociopath
schizophrenic
etc.

mostly, people use the word crazy for behavior that is nothing close to the mental illnesses that exist.

05/30/2011

Biomarkers – mainly defined as surrogates serving as indicators for specific biological states – play an ever-increasing role in neuroscience and especially in the management of multiple sclerosis, scientists reported today at the 21st Meeting of the European Neurological Society (ENS) in Lisbon. In analyzing gene expression patterns, immunological changes and imaging abnormalities, physicians are now able to detect complex nervous diseases at an early stage, to better discern them from other types with similar clinical manifestations, to better foresee the outcome and to evaluate whether or not a patient responds adequately to a specific therapy.

Biomarkers – surrogates which can be objectively measured and used as indicators for certain biological states, salutogenetic or pathogenetic processes or responses to pharmacological treatments – are of increasing importance in many areas of modern medicine, but especially so in neuroscience. Neurological diseases are most complex in nature, sometimes difficult to detect, and when relying only on clinical examinations, the effect or ineffectiveness of a therapy might become evident at a late stage. “especially in multiple sclerosis (MS) and some related disorders such as optic neuritis and neuromyelitis optica, a number of new biomarkers now greatly help us to quickly and non-invasively confirm or reject a diagnosis, to anticipate the outcome and to check whether or not the chosen therapy is effective in this particular patient,” Prof. Massimo Filippi said today at the 21st Meeting of the European Neurological Society (ENS) in Lisbon. More than 3,200 neurological experts from around the world are currently discussing the latest developments in all areas of their specialty in the Portuguese capital. Massimo Filippi, Professor of Neurology, heads the Interdepartmental Research Programme “BrainMap” and the Neuroimaging Research Unit at the Scientific Institute and University “Vita-Salute”, Ospedale San Raffaele in Milan, Italy. “These are big steps towards therapies that can be speedily customised to a specific patient’s situation in these most burdensome types of diseases.” 600.000 Europeans suffer from multiple sclerosis According to epidemiological studies, about 600.000 Europeans and 2.8 million persons worldwide suffer from MS, an inflammatory disease in which the myelin sheaths insulating the axons in the brain and the spinal cord are disintegrated, causing a wide array of clinical manifestations and leading to progressive physical and often cognitive disability. “The huge variability of symptoms, caused by the fact that MS can affect any part of the CNS, along with a lack of meaningful laboratory and paraclinical tests, led in the past to delayed or uncertain diagnoses,” Prof. Filippi added. “we are that much happier, therefore, that in recent years we could trace a remarkable number of biomarkers, allowing for an improved and quickened assessment of the disease and its progression.” Improved MS diagnosis and differential diagnosis Optic neuritis, an inflammation of the optic nerve potentially leading to a total loss of vision, can be an early sign for MS. “we now found out that the gene expression patterns in a whole blood analysis show significant differences in patients with optic neuritis compared to healthy controls, which can make an early detection of MS easier in the future,” Prof. Filippi said. Neuromyelitis optica (Devic’s disease) is characterised by inflammatory-demyelination and irreversible tissue loss concentrated in the spinal cord and the optic nerve. Seen by some as a subtype of “ordinary” MS and by others as a different, independent disease, it needs a different course of treatment than MS to achieve optimal results. “Neuromyelitis optica is characterised by an autoantibody profile distinct from that of MS, allowing for an improved differential diagnosis and an early start of the appropriate therapy,” Prof. Filippi added. Anticipating disease progression In MS, neurologists discern different phenotypes – including the relapsing-remitting, the primary progressive and the secondary progressive. Each of these has a different prognosis and may require different therapeutic approaches. As a consequence, there is an urgent need to define their pathophysiology. “some of our new biomarkers make this job much easier,” Prof. Filippi explains. “for example, in so-called black holes, lesions with irreversible tissue damage, the patterns of the microglia activation are different in progressive MS as compared to the relapsing subtype. MR measures could also help characterizing the heterogeneous clinical phenotypes of the disease. In particular, patients with progressive MS have an over-recruitment of the cervical cord on functional MRI scans, which is more pronounced in secondary progressive than in primary progressive MS. In relapsing-remitting MS patients, diffusion tensor magnetic resonance imaging (DT-MRI) allows distinguishing the effects of specific tract damage on disability and cognitive impairment. Finally, in neuromyelitis optica, the presence of NMO-IgG (antibodies which destroy aquaporin-4, a protein serving as a water channel through the cell membrane) already in an early stage identifies patients with a worse prognosis.” Evaluating the response to treatment for MS Does an individual patient respond to treatment? This crucial question, too, can in many cases be answered with hitherto unknown efficacy due to new biomarkers and technology to measure them. “The longitudinal atrophy of the spinal cord, a potentially important indicator for disease evolution and treatment response, can now be evaluated more effortlessly by a new segmentation method,” Prof. Filippi continues. “Whether or not a patient responds to natalizumab, a synthetically created monoclonal antibody designed to block the destructive activity of white blood cells in MS, can be assessed by the amount of natalizumab binding to mononuclear cells found in peripheral blood. a marker for the chances that cladribine — a drug targeted to inhibit the immune system overactive in MS patients –will actually reduce disease activity is the amount of activity measured before treatment: the more relapses, the more active brain lesions and the more progression in disability, the more effective the drug will probably be. The effectiveness of an immunosuppressive treatment in neuromyelitis optica can in turn be measured by the NMO-IgG (aquaporin-4-antibody) level: the lower it is, the better the response to therapy; the higher it is, the more probable are relapses.” a new area in MS assessment “with these discoveries, and many more possible biomarkers still under investigation, we are embarking on nothing less than a new area of CNS disease assessment,” Prof Filippi concludes. “Instead of being in the dark for months and years, or dependent on very expensive and burdening diagnostic tools, we increasingly understand an easier-to-read bio-language of the body. It is leading us on relatively simple paths to the right diagnosis and letting us watch the development of disease and/or treatment. we expect this shift in diagnostic paradigms to continue and to yield even more exciting possibilities within the next few years.”  

There’s an old adage that cowboys don’t cry.

They are said to have a tough interior that matches their rugged exterior.

For country-music star Clay Walker, the cowboy in him was put to the test in 1996 when he was diagnosed with multiple sclerosis.

“I was visibly upset. I was shaken to the core – the world kind of started spinning. Literally, I felt like I was going to faint when they said it. it wasn’t real. And it scared me to death,” Walker said.

“I prayed a lot, and then I really started searching out what MS was and trying to learn about it, because I didn’t even know what it was. I thought it was muscular dystrophy. I didn’t know.”

Multiple sclerosis is a disease of the nervous system that affects the brain and spinal cord when there is damage to the myelin sheath – the material that covers and protects nerve cells – according to the National Institutes of Health.

Symptoms can include vision problems, muscle weakness, trouble with coordination and balance, sensations of numbness or prickling, pain, and thinking or memory deficits. MS affects more than 400,000 people in the U.S., and 2.1 million worldwide, according to the National MS Society.

Walker’s disease presented itself first with double vision, and he then started having weakness and tingling in his right hand and right leg.

After an MRI and spinal tap, he was diagnosed with MS and was told he would be in a wheelchair within four years and dead in eight.

Fifteen years later, the 41-year-old continues to prove that prognosis wrong as he kicks off a U.S. tour tonight at the San Bernardino County fair.

At the time he was diagnosed, new medications were becoming available for treatment of MS, but his first doctor did not prescribe him any, Walker said. his second doctor put him on a drug that did not work.

Finally, a third doctor prescribed him Copaxone, which Walker says has kept him in remission – minimal symptoms and no progression of the disease – for the past 13 years.

So, he says, his message to people suffering from MS is: “If at first you don’t succeed, try, try again.”

“People talk about attitude all the time – having a positive attitude. I think attitude is such an overused word that people don’t really understand where attitude comes from,” Walker said. “So if I could give a little lesson it would be this: Your will is more important than your attitude, because your will affects your attitude – that is where your attitude comes from.”

Walker’s will during the two years he was suffering from the disease kept him going. he was still performing as a musician, though he had a slightly lighter schedule.

He would take steroids to shrink the swelling in his brain – which occurs when the body attacks the nerve cells – but the drugs made his whole body break out into a rash.

“There was some pretty bad things in the first two years, but nothing was worse than the psychological damage that it was doing on me,” said Walker. “I was just scared. And I had never been scared before in my life. But for those two years I was.”

When Walker was first diagnosed, he was a rising star in the country music world. just three years prior, his first two singles – “Live Until I Die” and “What’s it to You” – reached no. 1 on the Billboard country chart. “Dreaming With my Eyes Open” and “If I could make a Living” did the same in 1994.

He decided he had to announce his condition to the music industry and to his fans. it was something he says he couldn’t hide and thought it was fair for people to know the truth.

He also wanted to prove a point.

“I think it can be inspirational because it has not affected my touring or my singing or anything,” Walker said.

“It’s important that other people who are diagnosed with MS, other neurological disorders or any other thing, that they know it doesn’t mean a death sentence and it doesn’t mean the end of your life as you know it,” he said. “It means that you can conquer a lot if you want to, and I’ve done it.”

Though Walker is now in remission, there are still days MS makes him feel weak. he tries to exercise every day because he says circulation is important for those with MS, and it helps boost the immune system.

He is constantly seeking a cure for MS and holds an annual MS fundraiser – the Clay Walker Charity Classic. The golf tournament will take place June 30 through July 2 in Pebble Beach.

He also performed in April, in Century City, at the Race to Erase MS benefit sponsored by the Nancy Davis Foundation for Multiple Sclerosis.

Walker says he feels a sense of duty to help those who are suffering from the disease. his prognosis tested his will, but it proved cowboys are tough and they don’t give up – at least not him.

“The cowboy in me made me want to find a cure and to fight for it. That’s the way I look at it,” Walker said.

“People that know me know I still rope and ride, and I still do all the things I did before I was diagnosed. so that’s important, you know, not to let anything, no disease, nothing, take away your passion and happiness.”

Find out more

Clay Walker

For more information on Multiple Sclerosis, go to nationalmssociety.org.

What: Country-music artist performing at the San Bernardino County fair.

When: 7:30 p.m. todaytonight.5/19

Where: San Bernardino County Fairgrounds, 14800 Seventh St., Victorville.

Tickets: $7.50 and $12.50; includes admission to the fair.

Information: sbcfair.com/2011.

Multiple sclerosis is a condition that affects the central nervous system including the brain and spinal cord. it is caused due to degeneration of myelin, a substance that forms a protective covering on the nerves. This leads to impairment in conduction of signals between the body parts, resulting in problems related to walking, writing, memory, speech, and so on, depending on the part of the brain and nervous system that is affected. there are about 350,000 cases of multiple sclerosis in Unites States alone. it is generally diagnosed in people between the age of 20 and 50; however, children and older adults are also likely to develop this disorder.

There is no established cause of multiple sclerosis, where it has been attributed to autoimmune diseases by researchers and neurologists. an autoimmune disease prompts the immune system to act against the body’s own cells or organs, thinking them to be foreign. This may lead to the immune system acting against myelin, resulting in its depletion. Though the body may produce more myelin to compensate for the loss, more often the reduction of myelin is faster than the production, resulting in multiple sclerosis.

Multiple sclerosis has been classified depending on the symptoms experienced by the patients. Some types of multiple sclerosis are mentioned below:

Relapsing-Remitting Multiple Sclerosis: This is the most common form of multiple sclerosis, characterized by a series of attacks, followed by partial or complete disappearance of symptoms. A person suffering from this type of multiple sclerosis has a relapse some weeks after the attack. This condition may continue for years together. This forms the initial stage of multiple sclerosis, where 70-80% patients report with the symptoms.

Primary-Progressive Multiple Sclerosis: This type of multiple sclerosis sets in gradually, where there is slow deterioration in the patient’s physical condition. in such cases there is no relapse, where the patient suffers from the disorder continuously from the time of its onset. Around 10-20% of multiple sclerosis cases come under this type.

The symptoms of multiple sclerosis include impairment in functioning of several parts of the body. Problems in vision such as blurred vision, sudden blindness or red-green distortion are one of the very first indicators of the disorder. Along with this a person may suffer from movement and balance problem combined with muscle weakness. The person may also feel dizzy, weak; feel tremors, have impaired speech and loss of sensation in different parts of the body. Around 50% patients suffer from mental disorders such as attention deficits, memory loss, decrease in concentration, depression, paranoia, and so on.

A neurologist diagnoses the disorders through a series of tests including MRI scan, electro-physiological test and examination of cerebro-spinal fluid. A neurologist considers many aspects while treating a patient with multiple sclerosis. The aim of the treatment is to reduce number of attacks and relapse, improving a person’s ability to recover from an attack, and slowing down further spread of the disorder. The treatment involves medication depending on the extent of the problem and medical history of the patient. Though multiple sclerosis cannot be completely treated it can be effectively managed through medication and therapy.

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Tags: about multiple sclerosis, facts and causes, multiple sclerosis, multiple sclerosis treatment, symptoms of multiple sclerosis

Multiple sclerosis patients held rallies across the country Thursday, calling on Ottawa and provincial governments to make the controversial “liberation therapy” available in Canada.

The therapy involves angioplasty to widen constricted neck veins, improving blood flow from the brain. but researchers have yet to prove that narrowing of the neck veins — CCSVI — is a symptom, or cause, of the disease.

Recent studies suggest not everyone with MS has CCSVI, although it might be more prevalent in those with advanced cases of the disease.

Patients who say liberation therapy has eased their symptoms have had to seek the treatment outside the country. Now politicians like Nova Scotia MLA Alphie MacLeod are joining the cause. his wife suffers from MS, and underwent liberation therapy last summer.

“She has seen an increase in energy and in the quality of life,” he told CTV News.

Rallies were held in Halifax, Ottawa, and Montreal, where rain couldn’t stop the crowds.

Among the protesters was Janine Baker, who posted videos on YouTube that document her condition before and after she underwent the therapy at a clinic in the United States.

She said the disease debilitated her to the point where she needed the help of a walker to move around.

“I was almost in a wheel chair,” she said. “I was living in my own home but was headed for assisted living.”

Baker paid for her therapy on June 2, 2010. afterwards, she said her symptoms eased to the point where she could look after her 90-year-old mother who had suffered a stroke.

“I became her full-time caregiver,” said Baker.

She was also able to travel and even do some rock climbing.

“That was like my inner 12-year-old being set free,” she said. “It was just fantastic.”

But like half of all MS patients who undergo treatment for CCSVI, the improvements seemed to diminish over time. Now Baker is looking at another round of therapy.

Another MS patient, Jamie Chalmers, is in the same position.

“The first three months, I felt like I was 20 again and six months later it’s coming back. The monster is coming back,” Chalmers said.

Going for a second, third or fourth treatment is costly — in the thousands of dollars. but the MS Society of Canada has said the liberation therapy in Canada should only be done as part of a clinical study.

The society sent a statement to CTV News on the protests.

“The MS Society of Canada respects the right of individuals to mobilize and voice their opinion on issues important to our community,” the statement said. “People living with MS have successfully drawn attention to MS issues resulting in real, positive change. For example, the federal government’s recent announcement of a nationwide monitoring system for MS will allow us to better understand the disease and allow people with MS to make better choices about their own care.”

But it added that work continues to “understand CCSVI’s relationship to multiple sclerosis.”

Clinical trials continue across Canada. A study underway in British Columbia is looking at whether those with MS do have blocked veins, while Saskatchewan is expected to announce new research into angioplasty.

Dr. Kirsty Duncan, Liberal MP for the Ontario riding of Etobicoke North, is fighting for clinical trials that may prove the effectiveness of liberation therapy.

“There is absolutely evidence to do clinical trials in Canada,” she said. “We need to know if this improves quality of life for MS patients.”

With a report from CTV’s Medical Specialist Avis Favaro and Lauren Drong

I just basicall need information on it for a project I have to do. all answers welcome!

I believe MS is a breaking down of the mylon sheath that allows nerve messages to be sent through the body. It progresses at different speeds but the result is a loss of the brains messages getting to the desired location. this applies to motor functions but I'm not sure about vital organs

Hope this helps.
Multiple sclerosis is the leading cause of neurologicl disability in young adults. usually it will strike around 20 and 50 yrs of age, with a peak of age 30 and women are afflicted twice as men.
I have a brochure you can read, email me and i can scan this info for your project ,
Go to Oly4TheHealingJuice.com , my email is there.

ms is an autoimmune disorder wherein the body's immune system "attacks" a substance called myelin, which insulates nerve cells. nerve cells, just like a copper wire, conduct electricity. and, like the conducting wire between your computer and your wall, the nerve cells are wrapped in a sheath. in the nervous system, the sheath is made of myelin. in ms, the body's immune system "chews up" the myelin.

One site is all you need (see below)

A clinical study that has been recently conducted on Neprinol use to treat Multiple Sclerosis has produced some surprising results.

Multiple Sclerosis (MS) is a progressive disease that damages the nervous system and affects the spinal cord, brain and optic nerves.

Symptoms of MS include numbness, paralysis and possible blindness.  MS symptoms occur and disappear, sometimes reoccurring months later and MS is classified as an autoimmune disease.  Doctors are unsure as to why the body suddenly starts attacking itself, but it has something to do with genetic and environmental factors.

Neprinol contains several enzymes whose main job is to break down fibrin.  Fibrin plays a role in blood clotting and the formation of scars in the body.  Fibrin will accumulate on the damaged nerves of patients with MS after myelin breaks down.

Neprinol helps break down the fibrin in the blood which is shown to be beneficial in patients with MS.  Many patients suffering with MS have seen significant responses when taking Neprinol and it has even helped to restore neurological function in some patients.

For more information about Neprinol take a look at enzymus.com

As a rule, I crave stability. in my job, in my home, in the people I surround myself with. I like a sure thing. Unpredictability, flakiness and variables outside of my control freak me out. Too much open space or free time, which can sound awesome at times, can stress me out. I prefer structure. a schedule of activities. Lists. Things I can plan on. and I don’t like it when people change my plans unexpectedly. I can adapt to change, but I appreciate a heads-up–and really would like to be involved in the decision in the first place.

Multiple Sclerosis obviously throws a huge wrench in my plans. It goes without saying, really, but you can’t plan for MS.

So, even though I know all this, why do I let it bother me so much when my symptoms suddenly act up, like they have this week? I was doing fine. or as fine as I’m used to, with the ever-present numbness in my right leg and a grab bag of other random, but pretty mild, symptoms. but yesterday, I noticed while taking a shower (shower water is a really great way to discover What’s New in Numbness), that my upper right thigh was also numb. okay. whatever. and then throughout the day, I began to notice how numb the back of my left leg was, as well as my left shin. Hold on. That’s not part of the deal. I’m willing to accept right Leg = Numb, but my left leg is supposed to be the steady one. I can’t have them both acting up on me. It makes walking and standing especially hard.

I wobbled through the day, clinging to and leaning on walls and countertops, staying seated during meetings and generally taking it slow. I hoped (and am still hoping) that this increase in numbness was a side-effect of the start of my Lady Time, but I’m still bothered by it because it’s not typical for my symptoms to get *this* bad in conjunction with my period (TMI? Deal with it.).

Anyway, I should know better than to worry about it. This is what happens with MS. Things change unexpectedly. there doesn’t have to be an explanation or warning signs. It just does what it does. I have no control. I know this to be true.

But three years since my diagnosis, I still resent how flaky this disease can be, like an unwelcome and inconsiderate house guest that invites friends over who drink all your beer, make a mess and stay too long. If it can’t tell me when extra symptoms are going to show up, I wish it could at least tell me how long they plan to stay. because I really don’t want to feel like this every day forever.