Sunday, December 31, 2006

Housing slump, dealmaking dominated state's business news in 2006
Lakeland Ledger - Lakeland,FL,USA
... The Cambridge-based firm won federal approval to resume sales of a multiple sclerosis drug, Tysabri, that was pulled from the market in February 2005 because ...

Saturday, December 30, 2006

just started Tysabri as of November 29

Hello my name is Randy (f) and I have had RRSP (relapsing remitting
secondary progressive) MS for 12 years now. I was recommended to this
group by another existing member. I have been reading the posts for two
or three weeks now and have responded to very few. But I find this
group to be very positive and enlightening to be a part of it.

I am 54 years old, I have 4 children 32, 31, 27 and 25 three girls and
one boy very luckily I was almost finished raising them before I was
diagnosed with this lovely disease lol. We also have five beautiful
grandchildren. I have been married for 34 years to my wonderful
supporting husband who has been my lover, my friend and my 100%
caregiver.

I have been through every treatment that has been offered throughout the
past 12 years. I have just started Tysabri as of November 29 with my
first infusion. Luckily I had no side effects or reactions to the
medication. But I have not seen any other real positive reactions to
this medication so far. I get my second does on December 29, I am very
hopeful and positive that this will slowly start to work for me. My
neurologist was very pleased that I was able to accept the medication so
well. They all said I'd look so great (what did I look like before lol)
so at least it made me feel a little bit better. Is anyone else in this
group on the same medication and if so what is your response been? I
know everybody is different so that probably was not a very fair
question.

I just wanted to introduce myself and I would be very happy to talk to
any and or all of you. Welcome to the many other new members that have
joined this group. I also wish everyone a very happy new year and maybe
there will be a cure on the horizon for all of us. Thanks again, smiles
Randy
Shares of Acorda Therapeutics of Hawthorne, a biomedical company that is testing Fampridine-SR, a drug that could help multiple sclerosis patients walk, increased 164 percent from their February offering price of $6 to yesterday's $15.84 close.
http://www.thejournalnews.com/apps/pbcs.dll/article?AID=/20061230/BUSINESS01/612300333/1066

Healthology survey


4. What treatments are you currently receiving or have you received in the past?




Currently
Receiving

Have Received
But Not Anymore

Have Never
Received




methotrexate


Avonex®


Rebif®


Tysabri®


cyclophosphamide


prednisone


Betaseron®


Copaxone®


Novantrone®


Other

Biogen Idec initiated with "neutral weight" | newratings.com

Thursday, December 28, 2006 1:40:04 AM ET
Prudential Financial


NEW YORK, December 28 (newratings.com) - Analyst Jason Zhang of Prudential Financial initiates coverage of Biogen Idec Inc (BIIB.NAS) with a "neutral weight" rating. The target price is set to $53.

In a research note published yesterday, the analyst mentions that robust sales of Avonex and Rituxan are expected to support the company’s share price. Tysabri may reach blockbuster status by 2009, the analyst says. While Biogen Idec is likely to witness pressure on Avonex’s market share due to competition from other MS drugs, Rituxan has limited scope for growth, given that the drug has saturated the NHL/CLL market, Prudential Financial adds.
http://www.newratings.com/analyst_news/article_1448747.html

Tuesday, December 26, 2006

Stem cells as cancer therapy
PhysOrg Tue, 26 Dec 2006 3:14 AM PST
It is widely hoped that neural stem cells will eventually be useful for replacing nerves damaged by degenerative diseases like Alzheimer disease and multiple sclerosis. But there may also be another use for such stem cells--delivering anti-cancer drugs to cancer cells.

Kaiser held in contempt
Contra Costa Times Tue, 26 Dec 2006 3:03 AM PST
Oakland hospital hasn't made sufficient progress on terms of consent decree to be more accessible to the disabled. Post a Comment

Chronic illnesses can be helped
Evansville Courier & Press Mon, 25 Dec 2006 10:18 PM PST
This is the third column in a series on chronic illnesses.
Higher Levels Of Vitamin D In The Blood May Lower Risk Of Multiple Sclerosis
Medical News Today Mon, 25 Dec 2006 0:13 AM PST
New research suggests that having higher circulating levels of vitamin D is associated with a reduced risk for multiple sclerosis, although this relationship was not seen for black and Hispanic individuals, according to a study in the December 20 issue of JAMA. [click link for full article]

Caregiving takes toll on men
NorthJersey.com Sun, 24 Dec 2006 9:54 PM PST
WEST CHESTER, Pa. -- Joe Wolf still remembers his wife, Joanne, as a healthy 18-year-old with long brown hair and a '61 Chevy. They met through a social group at a Presbyterian church. They got married and had two children.

Alternative To Embryonic Stem Cells Stem May Be Provided By Cells Found In Adult Hair Follicles
Medical News Today Sun, 24 Dec 2006 2:10 PM PST
Having recently identified the molecular signature of these epidermal neural crest stem cells in the mouse, their research resolves conflicting scientific opinions by showing that these cells are distinctly different from other types of skin-resident stem cells/progenitors. Their work provides a valuable resource for future mouse neural crest stem cell research. [click link for full article]

The Immune Response Corporation Announces New Trading Symbol As One-for-100 Reverse Stock Split Takes Effect
RedNova Wed, 20 Dec 2006 9:04 PM PST
CARLSBAD, Calif., Dec. 20 /PRNewswire-FirstCal

Study Shows Vitamin D May Cut Risk of Getting MS
RedNova Wed, 20 Dec 2006 3:05 PM PST
By RONALD KOTULAK, SPECIAL FROM THE CHICAGO TRI

Vitamin D May Fight Multiple Sclerosis
First Coast News Wed, 20 Dec 2006 2:13 PM PST
CHICAGO (AP) -- An abundance of vitamin D seems to help prevent multiple sclerosis, according to a study in more than 7 million people that offers some of the strongest evidence yet of the power of the "sunshine vitamin" against MS.

Stakeholder Insight: Multiple Sclerosis - Disease-modifying efficacy and side effects guide treatment choice
Pharmaceutical Business Review Wed, 20 Dec 2006 10:47 PM PST
Introduction The disease-modifying drugs are considered by physicians to represent a significant advance for the management of MS. However, none is fully effective and there are problems with regards to side effects, dosing regimens and cost.

Vitamin D May Reduce Risk of MS, Study Says
RedNova Thu, 21 Dec 2006 6:06 AM PST
Researchers have found new evidence that people with higher blood levels of vitamin D have a reduced risk for developing multiple sclerosis. MS is thought to be an autoimmune disease, meaning that it causes the body's own immune system cells to turn against some healthy part of the body.

Study finds people with higher Vitamin D levels less likely to develop MS
San Antonio Express News Wed, 20 Dec 2006 3:31 PM PST
Vitamin D is called the "sunshine" vitamin. Much of the Vitamin D circulating in your body right now comes from the sun. A new study published in Wednesday's "Journal of the American Medical Association" found people with the highest levels of Vitamin D were 62 percent less likely to develop multiple sclerosis, a chronic nerve-damaging disease.

Vitamin D May Protect Against MS
MedicineNet.com Wed, 20 Dec 2006 12:37 PM PST
Title: Vitamin D May Protect Against MS Category: Health News Created: 12/20/2006 Last Editorial Review: 12/20/2006

Rituxan linked to two deaths, FDA reports
North County Times - Escondido,CA,USA
... Last year, Genentech suspended sales of another drug, Tysabri, due to reports that two patients taking the drug for multiple sclerosis had contracted PML. ...


Biogen issues alert after 2 Rituxan deaths

By Stephen Heuser, Globe Staff | December 19, 2006

Biogen Idec Inc. said yesterday that two patients using its drug Rituxan have died of a rare brain infection, the same one that shadows its multiple sclerosis treatment Tysabri .

In a letter sent to doctors, Biogen and Genentech Inc., which co-markets Rituxan with the Cambridge drug maker, warned that the two patients had contracted fatal progressive multifocal leukoencephalopathy, or PML.

Both patients were being treated for lupus, a disease in which Rituxan use is still considered experimental.

The drug is approved only for use in rheumatoid arthritis and non-Hodgkin's lymphoma , a form of blood cancer, but doctors are allowed to prescribe it for other diseases at their discretion.

In a posting on its website, the Food and Drug Administration said it was looking into the deaths.

The "FDA is working to gather more information about Rituxan and PML and to strengthen the warnings about PML in the Rituxan product label," the agency said.

The FDA warned doctors who prescribe Rituxan to be on the lookout for PML symptoms, which include dizziness, difficulty talking, and vision problems.

The disease, a viral brain infection that is usually fatal, strikes patients with compromised immune systems.

Last year, Biogen Idec withdrew Tysabri from the market shortly after its introduction, after three cases of PML were reported and two of the patients died. After a Food and Drug Administration hearing, the company brought Tysabri back to the market earlier this year.

Rituxan is one of the biggest-selling biotechnology drugs in the world, generating $1.8 billion in sales in 2005.

Biogen Idec recorded $709 million of that revenue, making Rituxan its second-biggest seller, after the multiple sclerosis treatment Avonex. Rituxan was discovered by Biogen Idec.

In a "Dear Healthcare Provider" letter posted yesterday on Genentech's website, the companies also said 23 cases of PML had been reported in blood-cancer patients taking Rituxan. The label for Rituxan already includes a warning about PML in those cases.

"This is the first time we've seen it outside the oncology setting," said Biogen Idec spokesman Tim Hunt. "We want to alert the prescribing public that it's been observed."

Both Rituxan and Tysabri are antibodies, a complex molecule modeled on a component of the human immune system.

Hunt said Biogen Idec didn't believe there was a link between the PML cases in Tysabri and Rituxan patients.

"I think the reality is, you see PML with a lot of patient populations," he said.

Hunt said PML is also seen in cancer and lupus patients not undergoing Rituxan treatment.

Rituxan is currently in clinical testing on patients with lupus, multiple sclerosis, and cancer. In addition to revising the label, the makers will obtain renewed consent forms from patients currently in Rituxan clinical trials. The patients who died were not in a clinical trial.

Stephen Heuser can be reached at sheuser@globe.com.

http://www.boston.com/business/globe/articles/2006/12/19/biogen_issues_alert_after_2_rituxan_deaths/

Saturday, December 23, 2006

Tegretol

carbamazepine (kar ba MAZ e peen)
Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR

What is the most important information I should know about Tegretol?

• Do not take Tegretol if you have taken an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) in the past 14 days.

• There are many other medicines that could cause a drug interaction if you take them together with Tegretol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

• Do not take this medicine if you have a history of bone marrow suppression, or history of allergic reaction to an antidepressant such as amitriptyline (Elavil), desipramine (Norpramin), imipramine (Tofranil), or nortriptyline (Pamelor).

• Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Tegretol should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking Tegretol. Tell your doctor if you become pregnant during treatment.

• Do not stop taking the medication even if you feel better. It is important to take Tegretol regularly to prevent seizures from recurring. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures.

• Tegretol can lower the blood cells that help your body fight infections. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

• Tegretol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

• Avoid drinking alcohol, which can increase some of the side effects of Tegretol. It may also increase the risk of seizures.

• Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by Tegretol.

What is Tegretol?

• Tegretol is in a group of drugs called anticonvulsants. It works by decreasing nerve impulses that cause seizures and pain.
• Tegretol is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Tegretol is also used to treat bipolar disorder.
• Tegretol may also be used for purposes other than those listed in this medication guide.


What should I discuss with my healthcare provider before taking Tegretol?
• Do not take Tegretol if you have:
· a history of allergic reaction to a tricyclic antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), doxepin (Sinequan), desipramine (Norpramin), amoxapine (Asendin), imipramine (Tofranil), or nortriptyline (Pamelor);
· a history of bone marrow suppression; or
· if you have taken an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) in the past 14 days.
• Before taking Tegretol, tell your doctor if you have:
· a history of serious side effects from any drug;
· liver disease;
· heart disease or congestive heart failure;
· lupus;
· a history of mental illness; or
· glaucoma.
• You may not be able to take Tegretol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Tegretol without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective non-hormone form of birth control (such as a condom, diaphragm, or spermicidal gel) while you are taking Tegretol.
• Tegretol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
• Older adults may be more sensitive to the side effects of this medicine.


How should I take Tegretol?
• Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
• Take each dose with a full glass of water.
• Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.
• You may open the extended-release capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.
• Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
• The Tegretol chewable tablet must be chewed before you swallow it.
• Tegretol can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.
• Tegretol can cause eye changes. Your doctor may recommend having your eyes examined regularly while you are taking this medicine.
• Do not stop taking the medication even if you feel better. It is important to take Tegretol regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures.
• Carry an ID card or wear a medical alert bracelet stating that you are taking Tegretol, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking Tegretol.
• Grapefruit and grapefruit juice may interact with Tegretol and cause unwanted side effects. Do not change the amount of grapefruit products in your diet without first talking to your doctor.
• It may take 4 weeks or more for you to start feeling better. Do not stop using Tegretol without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
• Store Tegretol at room temperature away from moisture and heat.


What happens if I miss a dose?
• Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
• Seek emergency medical attention if you think you have used too much of this medicine.
• Symptoms of a Tegretol overdose may include shallow breathing, fast heartbeat, nausea, vomiting, urinating less or not at all, muscle twitches, restlessness, seizures, tremors, slurred speech, staggering walk, and feeling light-headed or fainting.


What should I avoid while taking Tegretol?
• Tegretol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
• Do not drink alcohol while taking Tegretol. Alcohol may increase drowsiness caused by Tegretol. It may also increase the risk of seizures.
• Avoid prolonged exposure to sunlight. Tegretol may increase the sensitivity of your skin to sunlight. Use a sun screen and wear protective clothing when exposure to the sun is unavoidable.
• Tegretol should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking Tegretol.


What are the possible side effects of Tegretol?
• Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• Call your doctor at once if you have any of these serious side effects:
· a red, blistering, peeling skin rash;
· fever, sore throat, body aches, flu symptoms;
· easy bruising or bleeding, unusual weakness;
· white patches or sores inside your mouth or on your lips;
· feeling short of breath, even with mild exertion;
· swelling of your ankles or feet;
· nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
· urinating less than usual.
• Other, less serious side effects may be more likely to occur, such as:
· feeling unsteady;
· mild nausea, vomiting, diarrhea, constipation, stomach pain;
· confusion, headache, blurred vision;
· feeling agitated or depressed;
· ringing in your ears;
· dry mouth, swollen tongue; or
· joint or muscle pain, leg cramps.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Tegretol?
• There are many other medicines that could cause a drug interaction if you take them together with Tegretol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.


Where can I get more information?
• Your pharmacist has additional information about Tegretol written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Click here for more information on Tegretol

http://www.drugs.com/tegretol.html

Thursday, December 21, 2006

Top Picks 2007: Ken Kam revisits Elan and Tysabri
Blogging Stocks - USA
... editor of Marketocracy's Marketscope, explains, "Last year, I also chose Elan as my top pick because I thought their multiple sclerosis drug, Tysabri, would be ...
REMYELINATION EXTENSIVE IN SUBSET OF THOSE WITH MS
A study by an international team of collaborators suggests that a substantial amount of natural remyelination can occur in people with MS. While previous studies had shown natural myelin repair in people with MS, this study found evidence of extensive myelin repair - not only in patients with relapsing MS, but also in a subset of patients with progressive disease.

The investigators examined completely remyelinated lesions (so-called shadow plaques) or partially remyelinated lesions (shadow plaque areas) in 51 autopsies of patients with different clinical courses and disease durations.

In about 20 percent of patients' brains studied, remyelination was extensive, not only in those with a relapsing course, but also in those with progressive disease. The extent of remyelination was variable. In 20% of the patients, the extent of remyelination was extensive, with 60-96% of the global lesion area remyelinated. Longer disease duration and older age at death were associated with more extensive remyelination. No link was found between the extent of repair and the age at onset, gender or type of MS.

Further research is needed to determine why some individuals show highly efficient myelin repair while others do not. These study results indicate that the variable and individual extent of remyelination must be considered in the design of future clinical trials seeking to promote CNS repair.

Center for Brain Research, Medical University of Vienna, Vienna, Austria
ONLINE EDUCATION FOR THOSE WITH MS
The Expert MS Patient, online at http://www.expertmspatient.com, is an educational tool that addresses your specific needs.

The site, created by the Consortium of MS Centers (CMSC) and the International Organization of MS Nurses (IOMSN), offers:
· Video programs, featuring CMSC and IOMSN members, addressing relevant MS topics. Transcripts of these topics will also be available.
· A searchable online database of Frequently Asked Questions (FAQs).
· An opportunity for you to ask questions, which will be answered by nurses, doctors, and therapists who specialize in MS care.

An advisory board, composed of CMSC and IOMSN members, reviews all material on the site.
MBP8298 HOLDS PROMISE FOR PROGRESSIVE MS
Following the sixth meeting of the independent Data Safety Monitoring Board, (which provides objective, independent safety monitoring of clinical trials) BioMS has received a recommendation to continue its pivotal phase II/III clinical trial for MBP8298 for the treatment of secondary progressive MS.

This was the sixth of several regularly scheduled reviews by the Data Safety Monitoring Board. The pivotal phase II/III study is now ongoing at trial sites across Canada and Europe.

Results of the Phase II and long-term follow-up treatment of progressive MS patients with MBP8298, which were published in the European Journal of Neurology, show that MBP8298 safely delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

Treatment and follow-up in patients in this DR2 and DR4 responder group - who comprise up to 75% of MS patients - had a median time to disease progression of 78 months as compared to 18 months for patients who received placebo.

"Our data suggest that we can safely delay progression of MS in an identified responder group of patients for extended periods of time," said Ingrid Catz, co-inventor of the drug and co-author of the Phase II study. "Recognizing the high variability of the disease in MS patients, the clinical and mechanistic evidence gathered to date supports the rationale of targeting patients with the HLA-DR2 or HLA-DR4 immune response gene. The identification of this responder group will improve efficiency toward the achievement of objectives in future clinical trials with MBP8298, while the potential for clinical responses in patients with other HLA haplotypes is further explored."

MBP8298 is a synthetic Myelin Basic Protein peptide (MBP) comprised of 17 amino acids. Administered as an intravenous injection, five minutes or less in duration, every six months, the drug is expected to induce immunological tolerance specific to the injected antigen.

"MBP8298 appears to have a mechanism of action somewhat like glatiramer acetate (Copaxone)," explains MSF Medical Advisor Ben Thrower, M.D. "Copaxone was designed to look like myelin basic protein and works by shifting the immune system to a less inflammatory state. MBP8298 appears to work in a similar fashion."

While these results are positive, they must be confirmed in the ongoing Phase III trial. To learn more, visit http://www.biomsmedical.com.
Vitamin D may fight multiple sclerosis
AP via Yahoo! News Tue, 19 Dec 2006 5:48 PM PST
An abundance of vitamin D seems to help prevent multiple sclerosis, according to a study in more than 7 million people that offers some of the strongest evidence yet of the power of the "sunshine vitamin" against MS.

Vitamin D may cut multiple sclerosis risk, study finds
Reuters via Yahoo! News Tue, 19 Dec 2006 1:57 PM PST
People with higher levels of vitamin D have a markedly reduced risk of developing multiple sclerosis (MS), according to a study published on Tuesday that may point to a promising way to protect against the disease.

Vitamin D May Lower Risk of Multiple Sclerosis in Whites
Health Scout Tue, 19 Dec 2006 5:12 PM PST
WEDNESDAY, Dec. 20 (HealthDay News) -- Could getting some extra sunshine help prevent the development of multiple sclerosis?

Vitamin D May Lower Risk of Multiple Sclerosis, Study Finds
RedNova Wed, 20 Dec 2006 4:20 AM PST
By Kathleen Fackelmann Vitamin D might help protect people from developing multiple sclerosis, an incurable disease of the central nervous system, a study reports today.

Higher levels of vitamin D in the blood may lower risk of multiple sclerosis
EurekAlert! Tue, 19 Dec 2006 1:10 PM PST
New research suggests that having higher circulating levels of vitamin D is associated with a reduced risk for multiple sclerosis, although this relationship was not seen for black and Hispanic individuals, according to a study in the December 20 issue of JAMA.

Schoolgirl Raises Jd2,000 for Multiple Sclerosis Patients
RedNova Tue, 19 Dec 2006 1:50 PM PST
According to "Jordan Times", a 15-year-old girl single-handedly raised more than JD2,000 for patients diagnosed with multiple sclerosis (MS).

Vitamin D May Lower Risk of Multiple Sclerosis in Whites
KOLD News 13 Tuscon Tue, 19 Dec 2006 2:49 PM PST
By Serena Gordon , HealthDay Reporter WEDNESDAY, Dec. 20 (HealthDay News) -- Could getting some extra sunshine help prevent the development of multiple sclerosis?...

High Levels of Vitamin D In the Body May Decrease the Risk of Multiple Sclerosis
Newswise Tue, 19 Dec 2006 2:28 PM PST
In the first large-scale, prospective study to investigate the relationship between vitamin D levels and MS, researchers at the Harvard School of Public Health (HSPH) have found an association between higher levels of vitamin D in the body and a lower risk of MS.

'Sunshine vitamin' linked to lower risk of MS in whites: study
AFP via Yahoo! News Tue, 19 Dec 2006 1:08 PM PST
A study published provides yet more evidence that vitamin D, the so-called sunshine vitamin, may protect against the crippling neurological disease multiple sclerosis (MS).


Biogen, Genentech issue warning for Rituxan
MarketWatch - USA
... Based on the antibody rituximab, Rituxan works by manipulating the immune ... Biogen's biggest revenue driver next to its popular multiple sclerosis therapy Avonex ...
Acorda Therapeutics Provides Update on Clinical Development of ...
Business Wire (press release) - San Francisco,CA,USA
... on feedback it received in a meeting with the US Food and Drug
Administration (FDA), it will design and conduct an additional Phase
3 trial of Fampridine-SR in ...

2006 - A Very Good Year in MS Research
PR Newswire (press release) - New York,NY,USA
... The FDA approved the return to market of Tysabri(R)
(natalizumab ... Since Tysabri's return to market last summer
there have been no new cases of PML reported. ...

MS drug unlikely to gain OK for Crohn's
Boston Globe - United States
... executive, James Mullen, says the Cambridge biotechnology
company is unlikely to receive approval from European regulators
to use its drug Tysabri to treat ...
See all stories on this topic

Dismay over MS treatment decision
BBC News - UK
Both the MS Society and the MS Trust believe the drug
Tysabri
could help slow the progression of disability in hundreds
of sufferers. ...
See all stories on this topic

Monday's Analysts' Upgrades and Downgrades
TheStreet.com - USA
... Stock is up 15% since the strong third quarter earnings report.
Tysabri also unlikely to see accelerated sales in the near-term,
based on channel checks. ...


Acordia Plans Added Trial
TheStreet.com - USA
Acorda Therapeutics (ACOR - commentary - Cramer's Take) plans an additional Phase 3 trial of its Fampridine-SR drug in people with multiple sclerosis. ...

Acorda to conduct additional MS drug trial
BusinessWeek - USA
In September 2006, the company said its Fampridine-SR MS drug improved the ... completed under a Special Protocol Assessment with the FDA, meaning Acorda sat down ...

Acorda Calls for 2 More Trials
Motley Fool - USA
... On Friday, Acorda updated investors on the progress of its MS drug, named Fampridine-SR. As expected, the FDA is requiring another ...

UPDATE1-Acorda to conduct additional Phase III trial for MS drug
Reuters - USA
... In September, the company had reported positive data from its earlier late-stage trial of the drug, Fampridine-SR. Acorda Therapeutics said the FDA requires ...

Market Report -- In Play (ACOR)
MSN Money - USA
Acorda Therapeutics announces it will design and conduct an additional Phase 3 trial of Fampridine-SR in people with MS Co confirmed that, based on feedback it ...

Acorda Therapeutics (ACOR) To Conduct Additional Phase 3 Trial for ...
StreetInsider.com (subscription) - Birmingham,MI,USA
Acorda Therapeutics, Inc. ... based on feedback it received in a meeting with the FDA, it will design and conduct an additional Phase 3 trial of Fampridine-SR in ...


Roche presents yet more promising data on MabThera
Pharma Times (subscription) - London,UK
... addition of rituximab to CVP confers long-term benefit. ... has shown promise in various other indications, notably rheumatoid arthritis and multiple sclerosis. ...


2006 - A Very Good Year in MS Research
PR Newswire (press release) - New York,NY,USA
... of the year include: * Acorda Therapeutics (Hawthorne, NY) announced positive results of a Phase 3, placebo-controlled clinical trial of Fampridine-SR, an oral ...


Drug maker sees room for change in federal approach
Boston Globe - United States
For Biogen Idec Inc., the return of the multiple sclerosis drug Tysabri to the market and continued sales growth for its cash cow, Avonex, were the highlights ...

Hawthorne-based Acorda Therapeutics will continue testing MS drug
The Journal News.com - Westchester,NY,USA
The company said it decided to continue testing the drug, Fampridine-SR, based on feedback it received from the US Food and Drug Administration. ...

Tuesday, December 19, 2006

Multiple Sclerosis

This 30 year old male had a week of visual
blurring described as "milkiness" involving
the left eye at the age of 13 years. At 24, he
experienced numbness and tingling in both
legs and stumbling gait. MR images show
high signal in periatrial white matter on
T2-weighted images, and low signal on T1
pre- and post gadolinium. These findings are
typical of the non-acute plaques seen in MS.
There is very little enhancement with gadolinium.
The lateral ventricles are somewhat enlarged.
Most of the lesion burden is in white matter,
but, as seen at a higher level, grey matter is
also involved.
Some details have been altered to protect confidentiality.
Keith A. Johnson (keith@bwh.harvard.edu), J. Alex Becker (jabecker@mit.edu)

http://www.med.harvard.edu/AANLIB/cases/case38/case.html

‘Sunshine vitamin’ protects against MS

Huge study suggests vitamin D reduces risk of debilitating disease

Image: Sunscreen









Mary Godleski / AP file
There’s some evidence that the incidence of multiple sclerosis is increasing in sunny regions including the South and West, possibly because people are avoiding the sun or using sunscreen to protect against skin cancer.
Updated: 11 minutes ago

An abundance of vitamin D seems to help prevent multiple sclerosis, according to a study in more than 7 million people that offers some of the strongest evidence yet of the power of the “sunshine vitamin” against MS.

The research found that white members of the U.S. military with the highest blood levels of vitamin D were 62 percent less likely to develop multiple sclerosis than people with low levels.

There was no such connection in blacks or Hispanics, possibly because there were so few in the group studied. Also, the body makes vitamin D from sunlight, and the pigmented skin of blacks and other dark-skinned ethnic groups doesn’t absorb sunlight as easily as pale skin.

<>The new research echoes findings in smaller studies that examined why the nerve-damaging disease historically has been more common in people who live in regions farther from the equator where there is less intense year-round sunlight.

“This is the first large prospective study where blood levels are measured in young adults and compared to their future risk. It’s definitely different and much stronger evidence,” said Dr. Alberto Ascherio, the senior author and an associate professor of nutrition at Harvard’s School of Public Health.

The study appears in Wednesday’s Journal of the American Medical Association.

“If confirmed, this finding suggests that many cases of MS could be prevented by increasing vitamin D levels,” Ascherio said.

Still, he said the findings don’t prove that a lack of vitamin D can cause MS, so it’s too preliminary to recommend that people take vitamin D pills to avoid the disease.

Sources of vitamin D
Vitamin D also is found in fortified milk and oily fish, but it’s hard to get enough just from diet. Sunlight is the biggest source of vitamin D, which is needed for strong bones. Other studies have linked high levels of vitamin D in the blood to lower risks of a variety of cancers.

The MS researchers worked with the Army and Navy in analyzing blood samples of military personnel stored by the Department of Defense.

More Health News



Military databases showed that 257 service men and women were diagnosed with MS between 1992 and 2004. The increased MS risk was especially strong in people who were younger than 20 when they entered the study. The researchers said that finding suggests that vitamin D exposure before adulthood could be particularly important.

Using blood samples to measure vitamin D levels “tends to nail it down in a much more reliable way” than studies that have relied on people’s memories of vitamin D exposure, said Dr. Nicholas LaRocca of the National Multiple Sclerosis Society.

MS is among the most common nerve disorders affecting young adults, mostly women. About 350,000 people in the United States and 2 million worldwide have MS, a chronic autoimmune disease in which the body attacks the fatty insulation that surrounds nerve fibers.

Avoiding the sun
Ascherio said there’s some evidence that its incidence is increasing in sunny regions including the South and West, possibly because people are avoiding the sun or using sunscreen to protect against skin cancer.

Some doctors think those practices also have contributed to vitamin D deficiencies in adolescents and young adults.

“There’s no question that vitamin D deficiency is an epidemic in the United States,” said Dr. William Finn, a vitamin D expert at the University of North Carolina at Chapel Hill. The MS study “is just one more reason to pay attention to it.”

MS symptoms vary but can be disabling and can include tingling pain in the arms and legs, fatigue and vision problems.

Doctors believe it is genetic and perhaps triggered in susceptible people by environmental causes, including possibly some viruses. Vitamin D deficiency could be another trigger.

It’s unclear how lack of vitamin D might contribute. In mouse experiments, the vitamin stimulated production of chemicals that fight an MS-like disease.

____________________________________________

Live Vote

Will this study cause you to change your diet or behavior in an attempt to help prevent multiple sclerosis? * 54 responses
Yes, I plan to start taking vitamin D supplements and eating more fish and fortified foods.
37%
Yes, this is exactly the excuse I need to take more tropical vacations!
5.6%
Yes, all of the above.
33%
I'm not sure what I'll do. I'd like to spend more time in the sun, but don't want to get skin cancer or wrinkles.
13%
No, I'm going to wait for more evidence about vitamin D.
11%
Not a scientific survey. Click to learn more. Results may not total 100% due to rounding.

http://www.msnbc.msn.com/id/16284822/

Clinical Trials – Active Research for MS

This year has been an active one for clinical trials focused on treatment for multiple sclerosis. Some treatments are very close to receiving approval from the FDA or other decision-making organization, while others are many years away but still offer hope of new therapies. The time until approval can generally be determined by the phase of clinical trial that the treatment is in. Some of the treatments that are currently in clinical trial are:
  • Fingolimod – Phase 3
  • Fampridine – Phase 3
  • Cladribine – Phase 3
  • MBP8298 – Phase 2-3
  • Sativex – Approved in Canada, Final in Europe
  • Campath – Phase 2
  • Neurovax – Phase 1-2

  • http://ms.about.com/b/a/257728.htm?nl=1
    Clinical Trials: Active Research for MS
    This year has been an active one for clinical trials focused on treatment for multiple sclerosis. Some treatments are very close to receiving approval from the FDA or other decision-making body...read more
    Uncertain Biogen Applying to Sell MS Drug for Crohn's
    RedNova Mon, 18 Dec 2006 10:05 AM PST
    By Jeffrey Krasner, The Boston Globe Dec. 16--Biogen Idec Inc. and Elan Corp. said yesterday that they have applied to the Food and Drug Administration for approval to sell Tysabri, a multiple sclerosis drug, to treat patients with Crohn's disease.

    Health calendar
    Gloucester Daily Times Mon, 18 Dec 2006 9:25 AM PST
    *Mondays, 10 to 11 a.m., Tai chi with Meredith Morgan. *Tuesdays, 9:45 to 11 a.m., Yoga with Mary Ann Wenniger. *Wednesdays, 12:30 to 1:30 p.m., Chair Yoga with Nana Dunn.

    'It was the start of a very different life'
    Guardian Unlimited Mon, 18 Dec 2006 0:51 AM PST
    Michelle Mullen had it all: good job, money, and a busy social life. Then she went to her doctor with numbness and blurred vision, and everything changed ...

    Biogen wants approval of Tysabri for Crohn's disease
    San Antonio Business Journal - San Antonio,
    TX,USA
    ... Tysabri was cleared to return to
    market in July, with restrictions, after previous
    clinical data was reevaluated, giving Cambridge,
    Mass.-based Biogen Idec and ...

    Elan and Biogen Idec Submit Supplemental Biologics License ...
    PharmaLive.com (press release) - Newtown,PA,USA
    ... of a supplemental Biologics License Application
    (sBLA) to the US Food and Drug Administration
    (FDA) seeking approval to market TYSABRI(R) (natalizumab) in the ...

    UPDATE 1-Elan, Biogen jump on Crohn's filing for Tysabri
    Reuters - USA
    ... and Biogen Idec on Friday said they asked
    US regulators to approve use of their multiple
    sclerosis drug Tysabri, which has been hurt by
    safety concerns, to ...

    Elan, Biogen seek Tysabri OK for Crohn's
    United Press International - USA
    15 (UPI) -- Irish firm Elan and US drug maker
    Biogen Idec said Friday they are seeking approval
    of multiple-sclerosis drug Tysabri for Crohn's
    disease. ...
    See all stories on this topic

    Elan wants to use Tysabri to treat Crohn's
    RTE.ie - Ireland
    Elan Corporation and Biogen Idec said today that
    they have asked US regulators to approve use of their
    multiple sclerosis drug Tysabri, which has been
    hounded ...