Patients with multiple sclerosis who choose to smoke marijuana to help relieve some of their symptoms may be harming their cognitive abilities, finds new Canadian research.

 

The researchers, with Sunnybrook Health Sciences Centre in Toronto, say they found that MS patients who regularly smoked pot appeared to have more difficulties with processing information and short-term verbal memory.

 

Study author Dr. Anthony Feinstein says MS patients should be aware of the risks of pot, because many are already dealing with cognitive problems.

 

“The significance of this finding is particularly important because MS is itself a cause of neuropsychological impairment in 40 to 65 per cent of patients, and therefore this research suggests that smoking marijuana may only be worsening the problem,” Feinstein said in a statement.

 

The study, published in the online edition of the journal Neurology, compared the mental skills and emotional status of a small group of 10 MS patients who said that they regularly smoked pot for symptom relief against 130 patients who didn’t use the drug.

 

The researchers found that the pot smokers performed poorly on tests that measured speed of thinking, cognition, and information processing. They were, on average, about 50 per cent slower on these tests than non-marijuana users.

 

The pot smokers also had a higher lifetime likelihood of developing psychiatric disorders, such as anxiety, depression and other mood alterations.

 

Multiple sclerosis can cause co-ordination problems, muscle spasticity, and partial or complete paralysis. It also affects the mind, impairing short-term memory and decision-making. As well, people with MS have higher rates of depression and suicide compared to the general population.

 

Feinstein admits that the study sample size was small and says his team can’t be sure that it was the marijuana that reduced mental sharpness and not the natural progression of the disease.

 

He says more studies are needed to replicate his team’s findings and to see whether cannabis-based drugs have the same effect.

 

In Canada, federal regulations allow some MS patients to apply for permits to possess and/or grow marijuana for medical reasons or to designate another person to grow it for the person who has the permit.

 

There are also prescription medications available that contain the active ingredient in marijuana, tetrahydrocannabinol (THC), sold under such names as Saltivex, Marinol and Cesamet.

 

The study subjects in Feinstein’s study used “street” pot as opposed to federally-provided medical marijuana or medications.

 

 

 

 

Trial Information

Summary: Are you between the age of 18 and 65 with a diagnosis of Multiple Sclerosis?

 

The Billings Clinic Research Center is currently conducting a research study to evaluate the safety and tolerability of a once weekly oral dosing of an investigational treatment for patients with Multiple Sclerosis. Qualified participants may receive study-related neurological examinations, physical examinations, laboratory tests, ECG’s, MRI’s, investigational study medication and compensation for time and travel.

PatientInclusionCriteria
Male/Female between the ages of 18 and 65; diagnosis of clinically isolated syndrome or a relapsing form(s) of Multiple Sclerosis; clinical relapse within the past three years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months; baseline EDSS score of 0-6.5.

Patient Exclusion Criteria
Primary progressive Multiple Sclerosis; history of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infections, or any current active infection; concurrent diagnosis of any other autoimmune disease (i.e., rheumatoid arthritis or lupus).

 

Contact: Mary Salle (Ext 6489) or Becky Kiesow (Ext 8473), Recruitment Team Billings Clinic Research Center 1045 North 30th Street Billings, MT 59101 Telephone: (406) 255-8470 or toll free at (800) 996-2663 Fax: (406) 255-8479 Email: research@billingsclinic.org  Profile Page: Billings Clinic Research Center, Billings, MT

MONTREAL – Canada has one of the highest rates of multiple sclerosis in the world and the country fails in providing adequate services for patients, a new study suggests.

 

The global survey by the World Health Organization and the Multiple Sclerosis International Federation focuses on the prevalence of the disease in more than 100 countries representing almost 88 per cent of the world’s population.

 

The Atlas of Multiple Sclerosis was launched on Wednesday,

September 17, 2008 at the beginning of a four-day conference on the disease.

 

The study said MS strikes 133 people out of every 100,000 in Canada, the fifth-highest rate among the nations surveyed between 2004 and 2007.

 

Only in the United States, Germany, Norway, and Hungary was the disease more prevalent.

 

Allan Thompson, a top official with the MS International Federation, says Canada has always been a model in terms of the treatment of MS and in addressing quality of life for MS patients.

 

“But I think even in Canada the services could be better,” Thompson said in an interview, noting that support for employment is a big issue for Canadians with MS.

 

“Staying in employment is so important for quality of life and self-esteem and we just simply ignore it in most countries and Canada would probably fall into that group as well.”

 

Stewart Wong, a spokesman for the Multiple Sclerosis Society of Canada, agreed.

 

“You can’t easily earn income without reducing the benefits that are given to you by the government in a seamless way,” he said.

 

“It means that in many cases people will choose not to work even if they are able to so they can afford their treatments and that’s a very unfortunate thing.”

 

Still, the study also highlights where Canada succeeds, Wong said.

 

“If someone has a first symptom of MS, they can go to a doctor, they can go to a neurologist, they can go to a support group; and that’s all within a couple of phone calls,” he said.

 

“That stands out for us.”

 

But Thompson believes the overall results highlight the lack of services, expertise, and training in the area of MS worldwide.

 

“We’re failing miserably and we’re failing in even the most affluent countries,” he said. “That’s something that needs to be addressed urgently for which there’s really no excuse.”

 

Multiple sclerosis is a chronic disease that attacks the central nervous system, causing inflammation and damage. It has also been linked to environmental and genetic factors.

 

Wong said 2.5 million people worldwide have MS.

 

The MS Society of Canada says 55,000 Canadians have the disease.

 

 

 

 

 

The Canadian Press

 

Updated Thu. Sep. 18 2008 8:31 AM ET

Teva to Present New Treatment Data at World Congress for Multiple Sclerosis

 

JERUSALEM,

 

Sep 15, 2008 (BUSINESS WIRE) –

 

 

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA | Quote | Chart | News | PowerRating) today announced presentations of several new studies at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal.  New data will be presented on COPAXONE(R) (glatiramer acetate injection), a leading therapy for relapsing-remitting multiple sclerosis (RRMS) treatment, covering early treatment with COPAXONE(R), long-term efficacy and safety.

 

In addition to Teva’s post-marketing studies of COPAXONE(R) in RRMS, the company will also present data on oral laquinimod, which is now being investigated in 2 global Phase III studies (www.tevaclinicaltrials.com) and on ATL/TV1102, a second-generation VLA-4 inhibitor which has recently published positive results from a Phase IIa study in RRMS patients.

 

Teva’s extensive work and continuous investments exemplified by these presentations represents the Company’s commitment to research that advances the understanding of MS and its goal to seek improved therapies to address unmet needs within the category. Teva R&D efforts in this area include a breadth of pipeline compounds focused on various areas of discovery which hold promise for the treatment of MS.

 

Platform Presentations/Poster Sessions

 

COPAXONE(R) Clinical Studies

 

– Treatment with glatiramer acetate protects axons in patients with clinically isolated syndromes: evidence from the PreCISe trial (Presentation # 17, September 18 at 11:40 AM)

 

– Treatment with glatiramer acetate delays conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome (CIS): subgroup analyses (Presentation # 32, September 18 at 3:30 PM)

 

– Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15 year Analysis of the US Prospective Open-label Study of Glatiramer Acetate (Presentation # 44, September 18 at 3:30 PM)

 

– The impact of long-term treatment with disease modifying therapy on disability progression in relapsing-remitting multiple sclerosis patients (Presentation # 26, September 18 at 3:30 PM)

 

– Long-term follow-up of immunomodulatory therapies in early relapsing-remitting multiple sclerosis (Presentation # 57, September 18 at 3:30 PM)

 

– Fatigue in relapsing-remitting multiple sclerosis — assessment of clinical neuropsychological and immunological parameters in patients treated with glatiramer acetate (Presentation # 478, September 19 at 3:30 PM)

 

– Glatiramer Acetate Reduces Multiple Sclerosis Severity: Analysis of Patients from the US Pivotal Studies Using the Multiple Sclerosis Severity Scale (Presentation # 454, September 19 at 3:30 PM)

 

– Short-term Immunosuppression with Mitoxantrone Followed by Long-term Glatiramer Acetate vs. Glatiramer Acetate Alone: Results at 36 Months in Patients with Relapsing-Remitting Multiple Sclerosis (Presentation # 3, September 18 at 3:30 PM)

 

Laquinimod

 

– Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: 9-month double-blind active extension of the Multi-center, Randomized, Double-blind, Parallel-group Placebo-controlled Study (Presentation # 31, September 18 at 3:30 PM)

 

– Laquinimod given before and after disease onset reduces inflammatory cell infiltration and demyelination in experimental autoimmune encephalomyelitis (Presentation # 842, September 19 at 3:30 PM)

 

ATL/TV1102

 

– VLA-4 antisense: an oligonucleotide targeting VLA-4 mRNA (ATL1102) significantly reduces new active lesions in patients with relapsing-remitting multiple sclerosis (Presentation # 81, late-breaking news, September 20 at 9:15 AM)

 

About COPAXONE(R)

 

COPAXONE(R) is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

 

COPAXONE(R) is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

 

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

 

About Laquinimod

 

Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech (OMX NORDIC:ACTI) developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb study in 306 patients was recently published in The Lancet and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced magnetic resonance images (MRI) disease activity by a median of 60 percent versus placebo in RRMS patients. Laquinimod also showed consistent and robust effect on all secondary MRI endpoints. In addition, the study showed a favorable trend toward reducing annual relapse- rates and the number of relapse-free patients compared with placebo. Treatment was well tolerated, with only some transient and dose-dependent increases in liver enzymes reported. Over 460 MS patients have received laquinimod in various Phase I-II clinical trials.

 

In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barr Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva expects to initiate the clinical development of laquinimod for Crohn’s disease and Lupus Nephritis in the near future.

 

About ATL/TV1102

 

ATL/TV1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4) originally developed by ISIS Pharmaceuticals, Inc. (Carlsbad, California), and licensed to Teva Pharmaceutical Industries Ltd. by Antisense Therapeutics Limited (ANP) (Australia).

 

VLA-4 is a clinically validated target in the treatment of MS inhibiting the trafficking of inflammatory cells to the site of inflammation. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS

 

A Phase IIa trial studying the safety and efficacy of ALT/TV1102 in RRMS patients was completed. The study showed a significant reduction of 54.4 percent in cumulative number of new active lesions in patients taking ATL/TV1102 for 8 weeks, compared to placebo, as measured by MRI. Teva is planning to continue the development of this new molecule to confirm its efficacy and safety.

 

About Teva

 

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

 

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

 

This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra(R) , Neurontin(R), Lotrel(R) and Protonix(R), the effects of competition on our innovative products, especially Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission (”SEC”).

 

SOURCE: Teva Pharmaceutical Industries Ltd.

 

Women with low vitamin D levels have more chronic widespread pain, a new study has found. The modest findings do not support the use of vitamin D status as a key determinant for chronic pain, researchers suggest, but they do raise interesting questions about the possible influence of endocrine or immunological factors. The work is published online August 12 in the Annals of the Rheumatic Diseases.

 

Chronic widespread pain is thought to be a multifactorial condition. To date, the focus has been on psychosocial influences, note the study investigators, led by Kate Atherton, MD, from the University College London Institute of Child Health, in the United Kingdom. Although associations between chronic pain and general psychological distress, depression, somatization, and other factors have been consistently reported, translating these observations into management strategies has been fairly unsuccessful, they note.

 

Vitamin D deficiency has been suggested as a new modifiable risk factor for chronic pain. Vitamin D is a hormone precursor, which is obtained either through diet or skin synthesis. Using a nationwide population sample of white British adults, the researchers wanted to examine the link between vitamin D and chronic pain.

 

Women With Vitamin D Levels of 75 to 99 nmol/L Had Less Pain

 

“To our knowledge, this study is the largest population-based examination of the association between vitamin D status and chronic widespread pain to date,” write the researchers. The work is also the first to consider related variations in lifestyle factors or to focus on white ethnic groups, they add.

 

The study included more than 9300 participants in England, Scotland, or Wales born during 1 week in March in 1958 who had completed a biomedical assessment at age 45 years. Of these, 6824 participants had data on 25-hydroxyvitamin D and pain.

 

Investigators found that chronic pain levels varied by 25-hydroxyvitamin D concentration in women, but not in men. “In our study, the lowest prevalence of chronic widespread pain was observed for women with 25-hydroxyvitamin D 75 to 99 nmol/L,” Dr. Atherton and her team report. “This is intriguing given that 25-hydroxyvitamin D 75 nmol/L has been previously suggested as the cut-off point for optimal bone health.”