Ottawa eyes expanded benefits

GLORIA GALLOWAY
From Friday's Globe and Mail

OTTAWA — The federal government is examining ways of addressing a gap that leaves millions of Canadians affected by moderate disabilities and illnesses without income support.

A report for Human Resources and Social Development Canada, commissioned by the previous Liberal government but completed after the Conservatives took office last January, says workers and their families are vulnerable.

“Much more than a crack, the problem concerns the absence of a social-insurance program for millions of working Canadians whose work or earnings are interrupted because of illness or disability,” writes its author, University of Victoria professor Michael Prince.

The gap exists because employment insurance provides 15 weeks of benefits to people who are seriously ill but are otherwise able to do their jobs. The disability benefit offered through the Canada Pension Plan, on the other hand, is intended for people who are so incapacitated by illness or disability that they will not be able to return to work for at least a year.

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But there exists a whole range of illnesses, Dr. Prince says — including arthritis, multiple sclerosis, AIDS, chronic fatigue syndrome, lupus and even some types of cancer — that create episodes of incapacitation followed by periods of good health. These sufferers don't qualify for CPP when their EI runs out because they don't fit the government's definition of disabled.

And for those who do qualify, there is often a lapse after the 15-week period of EI ends and before CPP disability benefits kick in.

Cheryl Elliott, a 40-year-old nurse from Kanata, a suburb of Ottawa, is glad to hear Ottawa is acknowledging the hole that has engulfed her and others with moderate or episodic disabilities.

In 1998, Ms. Elliott was diagnosed with relapsing MS that left her paralyzed and using a wheelchair. She received EI benefits and started to gradually get better. But the benefits ran out before she was well enough to go back to work full-time. And she had no long-term or short-term disability insurance.

“I tried to return to my predisability employment as a nurse but I was given a job that I clearly could not do,” Ms. Elliott said yesterday.

Although many workers have access to long-term disability insurance — either privately or through their employers — to help bridge the period between the two programs, more than 7.3 million do not. They include more than 62 per cent of those who are self-employed and more than 44 per cent of people who are employed by somebody else.

Dr. Prince recommends three options to address the problem: extending EI sickness benefits, introducing a benefit within the CPP program that would cover partial disabilities, or creating a program that would fall between CPP and EI.

A subsequent analysis of Dr. Prince's report points out that he made no attempt to estimate the costs of those options. Dr. Prince agreed, during a telephone interview this week with The Globe and Mail, that a full costing would have to be done before the measures can be fully debated.

But he pointed out that while the Conservatives were in opposition they were on record as supporting an extension of EI benefits by 35 weeks to those who suffer from a serious or prolonged illness.

Colleen Cameron, a spokeswoman for Human Resources Minister Diane Finley, said yesterday: “We are aware of the concerns outlined in this report and that there are some persons with disabilities experiencing a gap in income supports. Our government continues to evaluate all programs and services to ensure they best meet the needs of Canadians. We are committed to supporting persons with disabilities and are looking into this issue.”

A departmental memorandum prepared for the assistant deputy minister in July of this year, and obtained by Ottawa-based researcher Ken Rubin, accepts the conclusions of Dr. Prince's report.

It says the objective of a new benefit policy would be to provide an incentive for people who have moderate or episodic illness to stay employed and to reduce the likelihood of disabled workers becoming fully dependent on income support.

The memorandum says more research must be done to document the gaps in coverage but it suggests that Dr. Prince's paper be shared with other sections of the department to develop a new policy.

Ms. Elliott said that she tried to re-enter the work force after her condition improved, but as soon as potential employers learned she had MS, the interviews ended. “It's not what I can provide to them,” she said, “it's, ‘How much of a liability are you going to be to me?' ”

Bayer Schering Pharma AG officially launched

New logo underlines specialty pharmaceuticals producer’s status as a Bayer Group company / Squeeze-out decision expected on January 17, 2007

New Bayer Schering Pharma Logo at the main entrance of the headquarters.
Berlin/Leverkusen – Berlin, Germany-based pharmaceutical company Schering has now been officially renamed “Bayer Schering Pharma AG.” The necessary entry in the commercial register took effect on December 29, 2006. Following the entry of the domination and profit and loss transfer agreement in the commercial register on October 27, 2006, this means another important condition for combining Bayer’s and Schering’s pharmaceutical activities has been fulfilled. The new logo has already been mounted on Bayer Schering Pharma’s headquarters building in Berlin.

“We are pleased that Schering now belongs to the Bayer Group in name as well, and that this is visible to the world,” said Bayer AG Management Board Chairman Werner Wenning. “We are continuing to make good headway with the integration process. The appointment of highly qualified people to important positions, particularly in research and development, is largely complete, and we were able to fill these positions equitably with employees from both companies. Now we are focusing on the next steps, particularly the squeeze-out process and realizing the planned synergies.”

Bayer Schering Pharma AG, headquartered in Berlin, is to be managed together with Bayer’s current pharmaceutical business as a division of the Bayer HealthCare subgroup. The resolution necessary for a squeeze-out is expected to be passed at an Extraordinary Stockholders’ Meeting of Bayer Schering Pharma AG to be held in Berlin on January 17, 2007. Employing the legally defined squeeze-out procedure, it is intended that the shares owned by minority stockholders be transferred to the main stockholder, Bayer Schering GmbH, a wholly owned subsidiary of Bayer AG, in return for adequate cash compensation.

The combined pharmaceutical businesses of Bayer and Schering had pro-forma sales of more than EUR 9 billion in 2005. Bayer Schering Pharma will rank among the world’s top ten suppliers of specialty pharmaceuticals. The company is already the world market leader in the field of hormonal contraception and has leading positions in multiple sclerosis therapy, hematology and cardiology, oncology and contrast agents. The new company also holds a leadership position in biotechnological research and has a promising research pipeline.

“We aim to occupy a leading market position in each of the specialty areas on which we are focused,” said Bayer HealthCare AG Management Board Chairman Arthur Higgins, who also serves as Management Board Chairman of Bayer Schering Pharma AG. “With a highly skilled and creative workforce, we are working on the development of new medicines to offer doctors and patients innovative therapies that significantly help to improve the quality of life.”


Important information:

This is neither an offer to purchase nor a solicitation of an offer to sell shares or American depositary shares of Bayer Schering Pharma AG (formerly Schering AG). At the time of commencement of the mandatory compensation offer, Bayer Schering GmbH (formerly Dritte BV GmbH) will file a tender offer statement with the U.S. Securities and Exchange Commission (SEC) with respect to the mandatory compensation offer and Bayer Schering Pharma AG (formerly Schering AG) will file a solicitation/recommendation statement on Schedule 14D-9 with the SEC in respect of the mandatory compensation offer.

Investors and holders of shares and American depositary shares of Bayer Schering Pharma AG (formerly Schering AG) are strongly advised to read the tender offer statement and other relevant documents regarding the mandatory compensation offer filed with the SEC when they become available because they will contain important information. Investors and holders of shares and American depositary shares of Bayer Schering Pharma AG (formerly Schering AG) will be able to receive these documents when they become available free of charge at the SEC’s website (http://www.sec.gov), or at the website http://www.bayer.de.

This news release contains certain forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our reports files with the Frankfurt Stock Exchange and our reports filed with the SEC (incl. on Form 20-F). Bayer AG and Bayer Schering GmbH (formerly Dritte BV GmbH) do not assume any liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

For kids, MS itself just half the battle

Correctly diagnosing disease can be tricky; sometimes, so is talking about it

By Judith Graham
Tribune staff reporter
Published December 28, 2006

Tiffany Jones stood before her classmates at Hillcrest High School, trembling. It was time to present her anatomy class project--and reveal a secret she'd closely guarded.

Eyes downcast, Jones described a high school senior with multiple sclerosis, a degenerative illness of the nervous system. "Numbness, tingling, poor balance, muscle weakness, bladder [problems] and forgetfulness" are among the girl's symptoms, she explained.

The 18-year-old "tries to stay positive because she has a lot of support from her family, friends and her church," Jones continued, her voice cracking. "[But] it makes her feel less of a person at times because she is living with a disease that she can't do anything about. Her name is--Tiffany Jones."

Jones paused, trying to keep her composure, as her classmates stared, some with their mouths open.

"There have been many nights that I sit up and cry just thinking about how I will live the rest of my life with this disease. I often wonder if I will be able to do the things I want in life," she continued, as the paper in her hand fluttered. "Will people think of me as a different person when they find out I have a disease or will they think of me as just being Tiffany?"

Until recently, multiple sclerosis was considered an adult illness. The medical community largely overlooked children with MS symptoms--a type of neglect unfortunately common for chronically ill children, especially those with relatively uncommon nervous system disorders, medical experts say.

But now, youngsters with MS are getting more attention as researchers search for the origins of this incurable illness, which strips nerves of their protective myelin coating and interferes with the brain's functioning, leading to the kind of problems Jones described to her classmates.


Diagnosis usually after puberty

As many as 10,000 U.S. children and teenagers--some as young as 5--have MS; another 10,000 to 15,000 have symptoms but can't be diagnosed with certainty, according to the National Multiple Sclerosis Society.

The youngest known patient with MS was 18 months old, but more commonly the disease surfaces after puberty when teenagers' bodies are changing and flooded by hormones.

Resources are scarce for these patients. With few exceptions, support groups are designed for adult MS patients. There are no medical guidelines for treating MS in children. None of the drugs used for adult MS patients has been tested extensively in school-age youngsters or teens. And it's still common for pediatricians and family doctors to assume children can't get the disease, making misdiagnoses routine.

"Neurologists know about this disease, but they're reluctant to treat children and adolescents because there are so many issues--dealing with school, with development, with behavioral issues, with the family," said Dr. Lauren Krupp, a neurologist who directs the National Pediatric MS Center at Stony Brook University Hospital in New York.

"And pediatricians know how to treat kids, but they don't understand MS or know anything about the medications."

Adding to the confusion, MS in youngsters is quite different than the disease in adults--so much so that researchers aren't certain if it's the same illness or a closely related variant.

For instance, in adults MS overwhelmingly afflicts white people, but at younger ages far more African-Americans, Asians and Hispanics are affected, according to Dr. John Richert, executive vice president of research and clinical programs at the National MS Society.

The disease also appears to progress more slowly in children, and "when we look at imaging studies of the brain, they look different in children with MS than adults," said Dr. Nancy Kuntz, a pediatric MS specialist at the Mayo Clinic in Rochester, Minn.

That may be because young people's brains are still developing, suggested Dr. Tanuja Chitnis, director of a pediatric MS center at Boston's Massachusetts General Hospital, noting that young people with MS appear to have more problems with processing language and visual/spatial perception.

Perhaps most puzzling is the relationship between MS and a separate condition known as acute disseminated encephalomyelitis, which afflicts children more often than it does adults. ADEM, as it's known, is an abnormal immune system response to a viral illness that typically lasts a few days or weeks but sometimes can recur.

"Often, it's hard to sort through what constitutes a bout of ADEM and what is an initial episode of multiple sclerosis in a child," said Dr. Joy Derwenskus, an assistant professor of neurology at Northwestern University's Feinberg School of Medicine. The distinction is important because treatments for the two conditions differ.

Understanding the link between viruses and MS is one of the main goals of a new network of six pediatric MS centers established by the National MS Society late last year.

Improving clinical care and support services for young people is another objective of the centers, whose Midwest location is the Mayo Clinic in Rochester, Minn.

"The biggest single problem these kids have is they don't know anyone else like them," said Maria Milazzo, a pediatric nurse practitioner at the Stony Brook MS center.


Learning to adjust

Nicole Caron was so scared after being diagnosed with MS last year at 15 that she didn't tell any of her friends what was wrong--or even admit the truth of her illness to herself. A basketball and soccer player, Nicole first felt numbness in her fingers, then extreme fatigue. Within a few months, she began getting excruciating headaches, blurred vision and pain behind her left eye.

The final diagnosis came after a brain scan and a spinal tap, but relief at knowing what was wrong was quickly followed by fear and denial.

"I didn't want to believe anything was wrong," said Nicole, who lives in North Attleboro, Mass., and is being treated at Massachusetts General Hospital. "I thought if I kept it to myself it would be all right. And I knew everyone at school would gossip, and I didn't to be the center of attention."

But the more Nicole concealed her worries, the lonelier she became. "I felt like a bad person because I wasn't telling anyone the truth," she said. After a month, she began letting friends know what was going on, but none of them had ever heard of MS.

Twice a week, Nicole left school for doctors' appointments; once, a teacher commented in class on her excused absences. "I started to cry, I was so upset," said Nicole, who gives herself daily injections of the drug Copaxone to help stall the progress of MS. Several weeks later, she disclosed her illness to the teacher.

For her mother, Judy Caron, the hardest part is accepting the unpredictability of MS, with symptoms that can come and go without warning.

"As a parent, you always try to fix everything for your children, but with this disease you have absolutely no control," she said.

In south suburban Country Club Hills, Carol Jones--Tiffany's mom--repeats a similar lament: "What's so scary about MS is, you can't tell what the future holds. You just don't know day to day what tomorrow is going to be."



Coping, with help

Tiffany's symptoms first surfaced in July 2005; after multiple visits with doctors and medical tests, a definitive diagnosis came a year later. In between, this slim dancer and pompom squad member with big, dark eyes couldn't understand why her arms and legs were going numb or why she suddenly would stumble or drop a cup.

"It makes you feel so uncertain and so afraid," said the soft-spoken girl, who started thrice weekly injections of the drug Rebif in November.

For support, Tiffany and her mom turned to a group of adults with MS who meet monthly in nearby Crete.

"It's really helpful to know what other people go through," but many of the group members are in wheelchairs and "I was thinking one day that could be me," she said.

At school, Tiffany told a few close friends about her illness early this fall but kept it concealed from other classmates and her teachers. She felt conflicted. She wanted people at school to know how her life had changed, but she didn't want to tell them.

Then, an assignment for her anatomy class became an inspiration to come forward. The teacher, by coincidence, had asked her to write a report on multiple sclerosis.

Standing before her classmates, Tiffany spoke of her fear, her faith and her confusion about what it means to stand on the edge of adulthood, trying to accept a lifelong illness.

"At times, I still feel like MS is taking over my life. I'm still struggling with that," she said. But "I have to tell myself to stop wondering what will become of me. I know that no matter what, I won't give up."

----------

jegraham@tribune.com

MedImmune In-Licenses Novel Inflammatory Disease Target

GAITHERSBURG, Md., December 28, 2006 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that it intends to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases under a recently signed license agreement with Japan Tobacco, Inc. (JT). MedImmune's initial efforts will focus on developing the current lead antibody, which aims to inhibit a receptor believed to play a key role in controlling adaptive immune responses, called inducible-costimulator (ICOS), and thereby regulate T-cell dependent activation of B cells. Inappropriate activation of T cells resulting in B-cell activation is implicated in a variety of autoimmune disorders.


"The addition of this novel target to MedImmune's inflammatory disease pipeline underscores our commitment to developing innovative therapies for the treatment of unmet medical needs, such as systemic lupus erythematosus (SLE or lupus), Sjogrens syndrome and rheumatoid arthritis," said Anthony J. Coyle, Ph.D., MedImmune senior director, research, and head, inflammation biology. "As we work to develop the anti-ICOS MAb as a potential treatment for such immune system disorders, we also hope to continue to collect scientific knowledge related to the role of signaling pathways in regulating immune response outcomes."

Under the terms of the agreement, JT will receive an undisclosed upfront payment, milestone payments and royalties on any future marketed products. JT retains exclusive development and marketing rights for the current lead antibody in Japan. MedImmune has exclusive development and marketing rights to this antibody for the rest of world and certain rights worldwide for other antibodies developed as a result of the agreement.

About Anti-ICOS MAbs

Preclinical study results indicate that ICOS is only expressed on a subset of T cells and is essential for T-cell dependent B-cell activation. In addition, ICOS is required for IL-17 secretion from activated T cells. IL-17 is a T-cell derived cytokine that is implicated in the development of various inflammatory diseases, including rheumatoid arthritis. In preclinical studies, ICOS-inhibition with MAbs was shown to be effective in models of rheumatoid arthritis, asthma, multiple sclerosis and lupus.

About Japan Tobacco

Japan Tobacco Inc. is the world's third largest international manufacturer of tobacco products. Since its privatization in 1985, JT has actively diversified its operations into pharmaceuticals and foods. JT entered into the pharmaceutical business in 1987 and established the Central Pharmaceutical Research Institute in 1993. JT is currently engaged in the research and development of new drugs in various areas such as glucose and lipid metabolism, anti-virus, immune disorders and inflammation, and bone metabolism. The company's net sales were 4.637 trillion yen in the fiscal year that ended March 31, 2006.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at http://www.medimmune.com.

This announcement contains, in addition to historical information, certain "forward-looking statements" regarding the development of inflammatory disease product candidates by MedImmune, Inc. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change current expectations and could cause actual outcomes and results to differ materially from current expectations. In addition, MedImmune can provide no assurance that these products will be commercially successful. In addition to risks and uncertainties disclosed in MedImmune's filings with the U.S. Securities and Exchange Commission, no assurance exists that development efforts for these products will succeed, that these products will receive required regulatory approval or that, even if regulatory approval is received, they will be commercially successful. MedImmune undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law or regulation.

CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,+1-301-398-4358, both of MedImmune, Inc.

Web site: http://www.medimmune.com/

Ticker Symbol: (NASDAQ-NMS:MEDI)

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Pediatric MS

Rare and often misdiagnosed, pediatric multiple sclerosis may be on the rise

Stuart Kellogg December 28, 2006

It just doesn’t seem fair, if words like “fair” may ever be used when speaking of illnesses. Multiple sclerosis — a disease in which the body’s immune system attacks its own myelin, a fatty tissue meant to protect the central nervous system — affects twice as many females as males. Symptoms typically manifest in adults between the ages of 20 and 45.

But Bryan Yglesias was 10 when, in August 2005, he was diagnosed with MS. And he was just 5 when he first complained of having “tingly hands.”

“Nothing fits,” his mother said. “The chances of a kid younger than 16 being diagnosed are between 2 percent and 5 percent, and MS is rare in Hispanics.”

Bryan lives in Hesperia with his father, Nick; his mother, Kathy; and his brother, Justin, 15.

Nick works for Hesperia High School’s athletic department; Kathy works in food service for the Hesperia Unified School District. Justin is a sophomore at Hesperia High School.

In February 2005 Bryan was diagnosed (misdiagnosed, Kathy thinks) with Bell’s palsy, a temporary facial paralysis caused by damage to one of the two facial nerves.

Put on steroids, he gained 33 pounds in just six months, going from 107 to 140.

Before becoming sick, Bryan, an avid soccer player, had played all three midfield positions. Now it was hard for him to balance.

“He walked as if he were drunk,” Kathy said. “At first I thought it was because he’d suddenly gotten so much bigger.

“But he also felt weak and couldn’t sign his name.”

Bryan recalled “feeling heavy and tingly on my right side.”

After two spinal taps ruled out Lyme disease, West Nile virus and meningitis, three MRIs of his brain revealed lesions where myelin had been destroyed.


Bryan Yglesias practices along with the rest of his soccer team during a recent practice in Apple Valley. Photos by AARON J. WALKER, Staff Photographer.
Bryan would be hospitalized three times at Loma Linda University Children’s Hospital: in August 2005 and again in January and February of this year.

In March, Bryan’s parents began taking him to the University of California, San Francisco’s Regional brand-new Pediatric Multiple Sclerosis Center.

There he is seen by a doctor, a nurse, two neurologists, a pediatric psychologist and a school psychologist.

The school psychologist, Mary Crittenden, assessed Bryan’s mood, memory and cognitive functions to establish a baseline for charting the progress of his disease.

“Our insurance doesn’t cover his treatment, so UCSF sees us for free,” a grateful Nick said.

Once a week, Bryan is given an injection of Avonex, a medicine designed to keep the body from attacking itself.

For fear of side effects, he started the Avonex on May 25, the last day of school.

“I get the shot at 5 p.m. and by 7 p.m. the side effects — tired, achy, chills — kick in,” Bryan said. “But they’re gone by the next morning.”

If it wasn’t covered by the family’s HMO, Bryan’s medication would cost them $1,600 a month for four injections.

Of the four forms of MS — relapsing-remitting, primary-progressive, secondary-progressive and progressive-relapsing — Bryan has relapsingremitting. The most common form, it is characterized by flare-ups of new symptoms or exacerbation of existing symptoms, followed by periods of partial or complete recovery.

“When he has a relapse,” Nick said, “Bryan goes to physical therapy: lifting weights, doing pushups, working with a balance ball, two or three times a week for two months.”

“We let him recover but don’t let him get lazy,” said Kathy.

Nick agreed: “We can’t let the disease win.”

UCSF’s is the only pediatric MS center west of the Rocky Mountains supported by a grant from the National Multiple Sclerosis Society (NMSS). The other five campuses are in Rochester, Minn.; Buffalo, N.Y.; Stony Brook, N.Y.; Boston, Mass.; and Birmingham, Ala.

But the Yglesiases have heard that a satellite may be started at the University of California, Los Angeles — much closer to home.

“Now that we’re seeing all these kids being diagnosed,” said Cindy Langwell, field programs manager for the Inland Empire Field Office of the NMSS’ Southern California Chapter, “it’s very important that the program come down here.”

Once a month, the NMSS hosts a chat line for teenagers with multiple sclerosis.

“But I want to meet other kids with MS,” said Bryan, who admits to feeling “different.”

He’s also noticed how often his father asks if he’s doing all right.

“That is love, Bryan,” Kathy reminded him. “Love and stress.”

At Maple School, where Bryan is in the sixth grade, only his closest friends know that he is sick.

“He doesn’t want the label ‘I have a disease,’ ” his mother said. “But I think other kids should know — just in case something happens.”

Word may get out soon enough.

Last year the Yglesiases took part in NMSS’ fundraising walk. And on April 14 Bryan plans to walk again, this time with his soccer team, the Apple Valley Storm. His favorite subject is math, but Bryan hasn’t yet chosen a career. “When he was little,” Kathy said, “he wanted to be a scientist and ‘cure something.’ Now he says no. “But I say, ‘Cure MS!’”

Kaiser held in contempt over access for disabled

By Alan Lopez

CONTRA COSTA TIMES
Kaiser Foundation Health Plan has been found in civil contempt of court for failing to meet the terms of a consent decree requiring its Oakland hospital to be more accessible to the disabled.

A decision reached Dec. 1 by U.S. Magistrate Judge Joseph Spero says Kaiser failed to comply or show it made all reasonable efforts to meet deadlines associated with the consent decree that stemmed from an Alameda man's lawsuit against the giant health care provider.

Kaiser signed the decree following the lawsuit brought against it by John Mannick, a disabled man who stayed at Kaiser's Oakland hospital for a week in 2003 and found that the bathrooms were inaccessible to people in wheelchairs.

"In particular," the decision says, "from the time of the execution of the consent decree, through at least March of this year, defendants repeatedly failed to comply with the timeline required under the decree. They failed also to notify plaintiff at all, during this period, of the delay or the causes for the delay.

"In addition," the decision notes, "at present time, defendants are in continuing violation of the requirement for an accessible ramp at an accessible patient discharge area."

In a statement, Kaiser said it was committed to doing all of the work outlined in the consent decree. Kaiser also claims to have completed all of the work in the consent decree except for an access ramp.

"The work completed includes an accessible room on the 6th floor ... and work related to parking spaces, entrances, 'paths of travel' and signage," according to Kaiser's statement. "We have agreed to complete the access ramp and accessible facilities on each of our four other medical surgical floors."

On Monday, U.S. District Judge Phyllis J. Hamilton signed an order adopting the Dec. 1 report and recommendation, which says Kaiser will be required to participate in compliance hearings in front of a magistrate judge every four months until all of the required work is completed.

At Kaiser's request, the order also gives the hospital more time to construct accessible patient rooms on the eighth floor and accessible restrooms/roll-in showers on the seventh, ninth and 10th floors.

Kaiser will be required to acquire all permits immediately, but the work will be done in two six-month phases to reduce the number of beds temporarily out of service during construction, according to the court decision.

Mannick, who was diagnosed with multiple sclerosis in 1982, has said he was shocked to find that the hospital lacked any accessible patient rooms and bathrooms, equipment such as lift slings to help patients in and out of bed and roll-in showers to accommodate people with wheelchairs.

The Americans with Disabilities Act, passed in 1990, requires businesses to have accessible facilities, services and parking for disabled people.

Mannick filed suit against Kaiser in December 2003. A jury trial was avoided after Mannick settled out of court for damages in August.

Reached by phone this week, he offered little comment.

"As soon as all the issues are dealt with," he said, "then I'll talk about it."

Mannick's attorney, Paul Rein, said various sanctions could have been levied against Kaiser as a result of it being in contempt of court. But he said the purpose was not to "damage" Kaiser.

"Our primary purpose is to make the premises accessible for disabled persons as soon as possible," said Rein, who specializes in disability access litigation. "We have no way of knowing how many other people may be affected."

One person affected was Jana Overbow, 44, of Oakland, who has rheumatoid arthritis and was hospitalized at Kaiser Oakland Hospital for eight days in July.

In a Sept. 29 declaration in support of Rein's motion to enforce the consent decree, Overbow made a statement saying that she had not been asked about her needs as a disabled person and was distressed to find that no accessible restrooms were made available to her.

Reach Alan Lopez at 510-748-1659 or e-mail alopez1@cctimes.com.

Longevity Gene Also Protects Memory, Cognitive Function

American Academy of Neurology
12/26/2006 9:33:05 AM

ST. PAUL, Minn – A gene variation that helps people live into their 90s and beyond also protects their memories and ability to think and learn new information, according to a study published in the December 26, 2006, issue of Neurology, the scientific journal of the American Academy of Neurology.

The gene variant alters the cholesterol particles in the blood, making them bigger than normal. Researchers believe that smaller particles can more easily lodge themselves in blood vessel linings, leading to the fatty buildup that can cause heart attacks and strokes.

The study examined 158 people of Ashkenazi, or Eastern European, Jewish descent, who were 95 years old or older. Those who had the gene variant were twice as likely to have good brain function compared to those who did not have the gene variant. The researchers also validated these findings in a group of 124 Ashkenazi Jews who were between age 75 and 85 and found similar results.

“It’s possible that this gene variant also protects against the development of Alzheimer’s disease,” said study author Nir Barzilai, MD, the director of the Institute for Aging Research at Albert Einstein College of Medicine in Bronx, NY.

Barzilai noted that many studies have identified risk factors associated with developing age-related diseases. “But little effort has been made to identify the reasons for longevity in exceptionally old people, and why they don’t develop disease. In studying these centenarians, we hope to learn what factors lessen their risk for diseases that affect the general population at a much younger age. Our results bring us a step closer to understanding the role that genes play in longevity.”

Work is being done to develop drugs that can mimic the effect of this gene variation, Barzilai said.

Approximately one in 10,000 people in the general population lives to the age of 100.

The study was supported by grants from the Einstein Aging Study, the Paul Beeson Physician Faculty Scholar in Aging Award, the Ellison Medical Foundation Senior Scholar Award, the National Institutes of Health, the Albert Einstein College of Medicine, and the Baltimore VA Geriatric Research and Education Clinical Center.

The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer’s disease, epilepsy, Parkinson disease, and multiple sclerosis. For more information about the American Academy of Neurology, visit www.aan.com.

Soy-derived protease inhibitor effective in animal model of multiple sclerosis

Reuters Health - Dec. 26, 2006

By Will Boggs, MD

NEW YORK (Reuters Health) - Bowman-Birk inhibitor (BBI), a soy-derived protease inhibitor, suppresses experimental autoimmune encephalomyelitis, according to a report in the current (November 1st) issue of Multiple Sclerosis.

"An oral agent with an extremely benign side-effect profile is shown to have significant effect in prevention and suppression of inflammation in the CNS of an experimental model of MS," Dr. Abdolmohamad Rostami from Thomas Jefferson University, Philadelphia, Pennsylvania told Reuters Health. "The hope is that it can be effective in MS patients as well."

Dr. Rostami and colleagues tested the efficacy of orally administered BBI concentrate in experimental autoimmune encephalomyelitis (EAE). BBI has previously been shown effective in treating benign prostatic hyperplasia, oral leukoplakia, and ulcerative colitis.

BBI administration at the time of induction significantly delayed the onset of EAE and reduced the disease duration, maximal clinical score, and cumulative score, the researchers report.

BBI treatment (400 mg/day) after the onset of EAE significantly reduced disease duration, cumulative clinical scores, and disease-related weight loss, the results indicate.

Treatment with BBI was also associated with a reduction in central nervous system inflammation, the researchers note, as well as inhibition of antigen- and mitogen-induced T cell proliferation.

"We are planning a phase I trial of BBI concentrate in MS patients," Dr. Rostami said. "We need to secure funding for the study from NIH or other sources."

Mult Scler 2006;12:688-697.

Pot law in peril

By: Jim Baron
12/27/2006

PROVIDENCE - Rhode Island's medical marijuana law, which allows people with debilitating medical conditions such as cancer, AIDS and multiple sclerosis to possess small amounts of the otherwise illegal substance without fear of arrest or prosecution will expire this year unless the General Assembly votes to reauthorize it.

Providence Rep. Thomas Slater, who, with Providence Sen. Rhoda Perry, championed the bill through its first passage, is working on making the law permanent.

The current law contains a "sunset provision" that will in effect erase it from the books on June 30 unless the legislature takes further action. That was done as a safeguard in case the law was abused or turned out to have unanticipated consequences. Slater said there has been only one incident linked to the measure since it became law and he intends to introduce an amendment that would eliminate the sunset clause as soon as the General Assembly returns to session next week. He said he would like to see the amendment pass early in the session, rather than waiting for the last-minute crush of legislation that comes at the end of every session, usually in mid-to-late June.

Slater's effort has the backing of House Majority Leader Gordon Fox.

"The sunset clause was placed into the medical marijuana legislation to be certain that no major problems occurred upon implementation, Fox said. "My understanding from the Department of Health is that all the related issues have been handled very smoothly. Given that fact, I will support Representative Slater's effort to repeal the sunset clause during the upcoming session."

"I want to get it on a fast track," Slater said Tuesday. "If we don't get it done by June and it gets vetoed, we could have a problem."

Gov. Donald Carcieri vetoed the measure when it passed during the 2005 session, but the House voted to override that veto when it returned from recess last January as its last order of business before adjourning and immediately starting the 2006 session. The senate had voted its override months earlier.

Carcieri spokesman Michael Maynard said Tuesday that the governor has not changed his negative view of medical marijuana, but added the administration wants to see the specific legislation before commenting on what the governor would do about a veto.

"The health department is receiving data and will make a recommendation to the governor," Maynard said.

The law allows an individual certified by a physician as having a debilitating illness to register with the health department so that person and two caregivers can possess up to 2.5 ounces of marijuana or 12 marijuana plants without facing arrest or prosecution by the state. The drug is still illegal to possess under federal law, but those on all sides of the debate agree it is unlikely the federal government would come after an individual patient under most circumstances.

Also, patients are on their own to obtain the marijuana, which is not available anywhere legally and must be bought though street dealers or other means.

Health Department spokeswoman Maria Wah-Fitta said that as of last week, 193 patients have registered for a medical marijuana card and 19 applications are pending. Also, 173 caregivers have been registered, with two more pending.
At this point, Wah-Fitta said, "we don't have a specific recommendation" about whether the sunset provision should be repealed.

Only one medical marijuana card has been revoked because of abuse since the law took effect a year ago, she noted.
A 48-year-old man from Exeter, Steven Trimarco, was arrested earlier this year for allegedly meeting with teenage girls online and offering to smoke marijuana with them.

The Trimarco arrest is just one incident among the nearly 200 patients who have registered, Slater noted, adding, "we're not even sure he had a medical marijuana card. That is confidential information. If Trimarco was a registered patient, the police gave out that information improperly, Slater said.

Slater told The Times there may be a couple of other "tweaks" to the law recommended by the health department.
He said the department suggested that criminal background checks be conducted on caregivers, to make sure none of them have a felony record. Slater says he does not think that would be a problem and is willing to work with the health department, which although it opposed passage of the law "has been pretty good about" executing it.

Slater said he is also looking at some of the things being done in California as far as establishing dispensaries where the drug can be obtained legally, but he is afraid "the federal government will jump right on that" to shut it down and arrest people. "That would get their attention quickly."

Bruce Mirkin with the Washington D.C.-based Marijuana Policy Project said his group will work in Rhode Island to support the renewal of the legislation, as it pushed to get the original law passed.

Mirkin said he believes "there is a pretty broad understanding within the legislature that this law has worked pretty well and helped a lot of people." He added "we have no reason to believe the governor's attitude has changed, but we hope that it will."

Rhode Island is one of 11 states with a law permitting the medical use of marijuana, and he expects more bills will be introduced in state legislatures this year, including efforts in Illinois and Minnesota. He said no state that has passed a medical marijuana law has subsequently repealed or weakened it. "What tweaking has been done has sometimes expanded it," Mirkin said, explaining that Maine subsequently increased the amount of the drug a patient could possess after the law was first passed.

The law has been effective, Slater said, to the extent that it has "given peace of mind" to patients who use the drug to relieve pain, nausea and other symptoms. "I don't think anyone argues that it is a cure-all."

The medical marijuana law lost one of its most zealous advocates with the death this month of 35-year-old Warren Dolbashian, a Tourette's syndrome patient who testified before legislative committees and played a prominent role in rallies and press conferences in support of the bill.


©The Pawtucket Times 2006

Multiple Sclerosis: Treating Multiple Sclerosis With Botox

What is Botox?
What is spasticity?
How does the botulinum toxin work?
How are botulinum toxin treatments given?
What are the advantages of botulinum toxin?
What are the disadvantages of botulinum toxin?
What are the side effects?
What does it mean to "develop antibodies" to botulinum toxin?
Is this treatment right for me?
Does insurance cover this therapy?
When should I call my doctor?
How will I know if the treatment is working?
For more information
What Is Botox?

Botulinum toxin, called botox for short, is a muscle relaxing medication used to decrease spasticity related to multiple sclerosis and other neurological conditions.

Botulinum toxin is derived from the bacterium Clostridium Botulinum and is in a class of drugs called neurotoxins. There are two types of botulinum toxin available for therapeutic use:

Botulinum toxin type A (Botox®)
Botulinum toxin type B (Myobloc®)

Your doctor will decide which type of botulinum toxin is more appropriate for you. Many other types of botulinum toxin have been identified but are not used to treat MS symptoms.

The FDA, despite the drug's effectiveness, has not yet approved the use of botox to treat MS-related spasticity.

What Is Spasticity?

Spasticity refers to a wide range of involuntary muscle contractions that result in muscle spasms or stiffness. Spasticity interferes with voluntary muscle movement and usually involves the muscles of the legs and/or arms.

Spasticity may vary, based on many factors including infections, stress, pain, temperature, position, and time of the day. Over time, severe spasticity may cause decreased range of motion in the affected limbs.

Spasticity is the result of an imbalance in the central nervous system, caused by a trauma or disease in the brain and/or spinal cord. This imbalance causes hyperactive muscle stretch reflexes, which result in involuntary contractions and increased muscle tone.

Some doctors believe that an increased sensitivity in the parts of the muscles that are responsible for contracting (tightening), relaxing, and stretching the muscles contribute to spasticity.

How Does the Botulinum Toxin Work?

Normally, the brain sends electrical messages to the muscles so that they can contract and move. This message is transmitted to the muscle by a substance called acetylcholine. Botulinum toxin works to block the release of acetylcholine, therefore the muscle doesn't receive the message to contract.

How Are Botulinum Toxin Treatments Given?

Botulinum toxin is given as an intramuscular injection (in the muscle). Your doctor will determine the muscle(s) in need of treatment.

If the muscles to be injected are small or difficult to reach, it may be necessary to send short electric impulses, or to record electric signals from the muscles, to ensure that the appropriate muscles are receiving the injected medication.

A very fine needle is used for the injection. Some people report minor and temporary discomfort from the injection. The medication does not sting or cause irritation after it has been injected.

You can expect the appointment to last from 1 to 2 hours.

The effects of the medication begin to appear from one to two weeks after the injection. The muscles injected should then relax.

What Are the Advantages of Botulinum Toxin?

Improvement of discomfort related to spasticity symptoms.
In some cases, improved ability to use the affected part of the body.
The medication is effective for two to six months, depending on the individual.
What Are the Disadvantages of Botulinum Toxin?

The benefit of botulinum toxin is limited to the injected muscles. Therefore, botulinum toxin may not be a good choice of treatment when many muscles are involved or when the spastic muscles are large.

The effect of the injections is temporary. Therefore, injections must be repeated over time to maintain the beneficial effects. Injections are not repeated more often than every 3 months to minimize the risk of developing antibodies to the botulinum toxin (see below).

What Are the Side Effects?

Side effects of botulinum toxin include:

Temporary weakness of the injected muscle and weakness in some nearby muscles
Brief flu-like symptoms (these may develop one week after the injections and usually only last for about one day)
What Does It Mean to "Develop Antibodies" to Botulinum Toxin?

There is a slight chance that you may develop antibodies to botulinum toxin. Antibodies to botulinum toxin cause the botulinum toxin to be less effective. If this occurs, switching to the other type of toxin (for example, from type A to type B) may be helpful. To minimize the risk of developing antibodies, specific guidelines are followed to restrict the frequency of injections and the dose of medication that is injected.

Is This Treatment Right for Me?

A doctor will perform a complete evaluation to determine if you are eligible to receive botulinum toxin therapy.

Does Insurance Cover This Therapy?

Insurance coverage varies greatly, depending on individual insurance plans. Check with your insurance company before treatment begins. Give them the following CPT (procedure) codes:

When Should I Call My Doctor?

Call your doctor:

If you think that the medication is not working (please wait at least 2 weeks after the injection)
If you are experiencing side effects that you think may be related to botulinum toxin
When the effects of the medication wears off
How Will I Know if the Treatment Is Working?

You will be examined during frequent follow-up appointments to determine if the treatment is working properly. Typically, you will be re-evaluated every 3 to 6 months, when the effect of the medication wears off, to determine if it is appropriate to repeat the injections.

For more information about Botox®, please call 1-800-44-BOTOX or visit the Website at www.botox.com.

For more information about Myobloc®, please call 1-888-GO-1-CALL or visit the Website at www.elan.com/products/neurology/myobloc/.

Reviewed by the doctors at the Mellen Center for Multiple Sclerosis Research at The Cleveland Clinic.
Edited by Charlotte E. Grayson, MD, WebMD, May 2004.

Portions of this page © The Cleveland Clinic 2000-2005

New Options for Treating Neurological Disease: Stem Cell Therapy

Decision Resources, Inc., Dec 2006, Pages: 25

Stem cell therapy development is challenged by controversy, intellectual property issues, and a high failure rate. Despite these challenges, stem cell therapy presents some of the most promising options for hard-to-treat and highly degenerative neurological diseases.

Get the Answers You Need to Shape Your Strategy

Stem cell therapy holds vast potential for treating degeneration or injury in areas of the body that are incapable of autonomous healing, such as the central nervous system (CNS). How can stem cells boost healing in the CNS? What are the limitations of these therapies in the CNS? What scientific and regulatory roadblocks exist for developing stem cell therapies for the CNS?

Several manufacturers are investigating stem cell therapies to treat neurological disease. What are the different approaches for developing these therapies? What value do different stem cell therapies offer, and what challenges do they face? How might these agents impact the different disease markets?

Stem cell therapies may represent the first true disease-modifying therapies for multiple neurological diseases, but their success will depend on many factors, including ethics, clinical trial design, and safety concerns. How are ethics affecting stem cell design? What can we expect from future stem cell clinical trials? Which stem cell therapies are likely to offer the best safety profiles?

Scope
Stem cell introduction: stages of stem cell differentiation, comparison of stem cell types, history of stem cell development.
Value of stem cells for neurological diseases: benefi ts and limitations of stem cells and their therapeutic value for multiple neurological indications, including Alzheimers disease and Parkinsons disease.
Emerging stem cell therapies for neurological uses: discussion of multiple companies initiatives into developing neurological stem cell therapies.

Outlook: hurdles for stem cell therapy development, discussion of which stem cell therapies are more likely to succeed.



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MS sufferers the losers in cannabis chocolate case

Published on 22/12/2006

Saviours? Mark and Lezley Gibson produced more than 20,000 bars at their Front Street home, sending them to MS sufferers who could provide medical proof of their condition

By Dave Gudgeon and Phil Coleman

THE collapse of a cannabis chocolate ‘industry’ following the prosecution of the Alston couple who ran it for people with multiple sclerosis has left many sufferers in distress, says a national charity.

Mark and Lezley Gibson produced more than 20,000 bars at their Front Street home, sending them to MS sufferers who could provide medical proof of their condition.

Production ceased shortly before the couple were convicted along with a friend at Carlisle Crown Court of conspiring to supply the class C drug.

The Gibsons, both 42, and Marcus Davies, 38, who lives in Camridgeshire, will be sentenced on January 26, though the judge has said they will not face immediate custody.

Mrs Gibson, who was diagnosed with MS 21 years ago, is adamant that using cannabis has saved her from a wheelchair.

All three had hoped to escape conviction because their motive was not to make money but to help MS sufferers ease symptoms.

Judge John Phillips told the jury that the law has to be applied as it is, and not as some say it ought to be and a recent Appeal Court ruling made it clear that can be no medical necessity defence.

He said: “It’s not lawful for unqualified individuals to assume the role of unqualified doctors by obtaining, prescribing, and supplying cannabis, whether in chocolate or otherwise. No doubt there’s a debate to be had on whether that should be the law.

“But the court is not the proper place in which that debate should take place.”

As the debate on the case continued, powerful evidence has emerged suggesting that the loss of the Canna-Biz bars has left many MS sufferers with no effective way to ease often crippling symptoms.

Helen Yates, of the national MS Resource Centre charity, said: “We’re getting calls from people who have been very distressed by this case.

“They’re distressed emotionally by the prosecution, and physically distressed in terms of the impact this case is now having on their symptoms. There are a significant number whose quality of life is being directly affected by this.”

She spoke of one 25-year-old for whom the chocolate was her only way of preventing incontinence, while another MS victim, aged 81, said the chocolate was the only thing that freed her from pain.

Ms Yates added: “We can’t condone law-breaking but in this case the law is wrong.”

Several Cumbrian MS sufferers also contacted The Cumberland News to speak of the impact on them.

They included Wigton woman Helen Wallage who said: “Because I walk badly, everything tenses up and I get burning sensations. The chocolate eases all that and makes those feelings disappear. It makes life bearable.

“There should be an exemption for people with MS who need to use cannabis. I feel so sorry for Mark and Lezley – they were only trying to help people like me.”

This week the THC4MS (Therapeutic Help from Cannabis for Multiple Sclerosis) website, set up by Marcus Davies, was displaying the following message: “We regrettably have to inform you that THC4MS, to comply with our judge’s ruling, have ceased manufacture and supply of Canna-Biz chocolate. THC4Ms has now reverted to a pressure group fighting for your right to use cannabis as medicine.”

During the trial Mark Gibson said he began making and supplying the cannabis chocolate about six years ago after a woman living in the Orkneys, became too ill to do it. Lezley helped out.

The jury heard that over the years about 36,000 bars were sent around the world to about 1,600 sufferers.

All had supplied medical notes to prove they has MS.

The service was funded by donations of cash and cannabis. The police took action after a package containing one of the Canna-Biz bars burst open at the Royal Mail sorting office in Junction Street, Carlisle.

After the verdict a spokesman for the Crown Prosecution Service said: “We prosecuted the case because it is an offence to possess or supply cannabis or to conspire to supply it.”

Health Tip: Understanding Ataxia

12.22.06, 12:00 AM ET

(HealthDay News) -- Ataxia, a Greek word meaning incoordination, describes a class of nervous system conditions that cause people to have uncontrolled movement of the limbs, face and body.
Ataxia may be inherited, or it can be brought on by other diseases or conditions.

According to the National Ataxia Foundation, the most frequent symptoms include problems with balance; poor coordination of arms, legs and hands; slurred speech; difficulty walking; and difficulty eating or writing. Hereditary ataxias can lead to deadly symptoms including difficulty breathing and swallowing.

Ataxia can also be a symptom of other conditions, including stroke, alcoholism, multiple sclerosis, or an injury to the head, the foundation says.

Norwegian stem cell company eyes Wis.

By SCOTT BAUER

MADISON, Wis.

Access to scientists working with stem cells and proximity to the WiCell Research Institute attracted a Norwegian biotechnology company to locate in Madison, Gov. Jim Doyle said Friday.

CellCura, Inc., is the fourth stem cell company to start or locate in Wisconsin the past two years, the governor's office said.

Doyle, who made his support of embryonic stem cell research a lynchpin of his successful re-election bid last month, wants Wisconsin to capture 10 percent of the stem cell research market by 2015. In April he directed the state Department of Commerce to spend $5 million to help recruit stem cell researchers like CellCura.

Wisconsin is the birthplace of stem cell research. University of Wisconsin researcher Jamie Thomson first isolated embryonic stem cells in 1998.

About 80 UW scientists are conducting a variety of embryonic stem cell studies, mostly using the five cell lines developed by Thomson and patented by the school's research arm, the Wisconsin Alumni Research Foundation.

WiCell is a subsidiary of WARF that does stem cell research and education and is the home of the National Stem Cell Bank.

Doyle's office said Wisconsin currently has 22,000 people working with stem cells which generates $7 billion for the state's economy.

Embryonic stem cell therapies could hold cures for a host of debilitating illnesses such as cancer, multiple sclerosis and Parkinson's and Alzheimer's diseases.

But the research is divisive because scientists destroy unused embryos from fertility clinics to obtain the stem cells, which are the basic material that give rise to nearly all organs, cells and other body tissues.

San Diego judge upholds state medical pot law

Published 12/21/2006

by Liz Highleyman

A San Diego judge earlier this month upheld California's medical marijuana law, rejecting a challenge by three counties contending that the state law puts them in conflict with federal policy.

"Medical cannabis patients everywhere can breathe easier," said Steph Sherer, executive director of Americans for Safe Access, a patient advocacy group, following the December 6 decision. "States can act to protect patients, and local officials are now on notice that they cannot hide behind the federal reluctance to acknowledge medical use."

San Diego County will appeal the decision.

The state's Compassionate Use Act, better known as Proposition 215, passed by a substantial margin in 1996. The law allows individuals with illnesses such as AIDS, cancer, and multiple sclerosis to use cannabis for medicinal purposes with a doctor's recommendation. An additional law passed in 2003 requires counties to implement a patient identification card program to enable police to identify legitimate medical users.

The federal government, however, does not recognize the laws of California and 10 other states, maintaining that marijuana has no legitimate medicinal value and that its use is illegal under all circumstances. The U.S. Supreme Court ruled in June 2005 that the federal Controlled Substances Act trumps state medical marijuana laws, but did not declare such laws invalid.

This past February, the San Diego County Board of Supervisors filed a lawsuit against the state, claiming that California could not require the county to implement the patient ID card system, since the state law is at odds with federal policy. San Bernardino and Merced counties later signed on to the suit.

"California authorized use of marijuana for medical purposes, but federal law has said marijuana has no legitimate medical use," said San Diego County Counsel Thomas Bunton. "California authorizes, and in fact encourages, people to use marijuana, when that is forbidden by federal law."

On November 16, Superior Court Judge William R. Nevitt tentatively ruled that this discrepancy does not prevent California from permitting medicinal cannabis use, as long as the state does not require residents or officials to act in ways that are directly prohibited under federal law.

This month, Nevitt reaffirmed his preliminary decision that the patient ID card system does not constitute a "positive conflict" with federal law.

The state attorney general's office, ASA, the American Civil Liberties Union, and the Drug Policy Alliance argued in favor of the Compassionate Use Act. The advocates represented Stephen O'Brien, an Oakland physician who specializes in HIV/AIDS care, and a group of patients who use medical cannabis, including one who died after the lawsuit was filed.

"This is a vital win for patients and a resounding step forward for the medical marijuana movement," said ACLU attorney Adam Wolf, commenting on the most recent court decision.

"This ruling upholds both the will of the voters and the legislature's attempt to help implement it," added ASA chief counsel Joe Elford. "The protections provided to patients under state law have been confirmed."

Deputy state Attorney General Leslie Lopez said Congress never intended to require states to enact identical laws.

"We are pleased that the court ruled that San Diego must follow California's medical marijuana law," said Dale Gieringer of the California chapter of the National Organization for the Reform of Marijuana Laws. "The ID cards will save the county money by avoiding needless arrest and prosecution of legal patients."

The week after the ruling was handed down, however, the San Diego County Board of Supervisors voted 4-1 in a closed session to file an appeal.

According to board Chairman Bill Horn, the judge did not directly rule on whether the state or federal government has ultimate authority over marijuana policy. "[Nevitt] kind of gave us the politically correct opinion that we ignored the will of the voters," he told the San Diego Union-Tribune. "Maybe the 4th District [Court] will give us an answer."

In contrast, Merced supervisors decided not to appeal Nevitt's ruling, and the county will begin issuing patient ID cards in accordance with California law.

Biotechnology for producing more tolerant immune system available for licensing

December 21, 2006 -- By Evelyn Boswell, MSU News Service

BOZEMAN -- Montana State University researchers have found a new way to fool the immune system into becoming more tolerant.

David Pascual, MSU professor of veterinary molecular biology, said the process will let people tolerate instead of over-react to certain antigens. Antigens are foreign substances that cause the immune system to respond, but some immune systems respond too strongly.

The discovery is good news for people with allergies, autoimmune diseases and inflammatory diseases like arthritis and multiple sclerosis, Pascual said. The discovery will let people use a nasal spray or take a pill to keep their bodies from overreacting to specific antigens. Their immune system will become non-responsive instead of producing allergic reactions or painful inflammations.

"We are pretty excited about it," said Pascual who noted that MSU has been working on the project for five years. The biotechnology is available now to companies or entrepreneurs that want to license it and develop it further.

The key to the biotechnology is a protein that can be fused to a broad range of antigens, Pascual said. By fusing the protein to a specific antigen, researchers can target diseases. The approach is effective at extremely low doses, Pascual said. In some cases, tolerance is produced after only one dose.

MS is one of many diseases that the new biotechnology could target. Becky Wiehe, regional program manager for the Montana Division, All America Chapter, National Multiple Sclerosis Society, said she is encouraged every time she hears about research projects that can help people with MS. She didn't used to hear such reports.

"There are many investigations in the research pipeline," Wiehe said. "That, to me, is exciting. It suggests we have new places to go, and we will get there."

At least 1,600 Montanans have multiple sclerosis, and much about the neurological disease of the brain and spinal cord is a mystery, Wiehe continued. Common symptoms are fatigue, tingling, numbness, and inflammation of the nerve to the eye, but symptoms come and go unpredictably in many people. Montana also has a relatively high number of cases which are related, it seems, to genetic tendencies and the state's distance from the equator.

MS becomes more common the farther you are from the equator, Wiehe said, theorizing that, "It might be a viral issue in colder climates."

She added that Montana's level of MS is comparable to those in other states and countries along the 48th parallel. She said it might also reflect the large number of Montanans whose ancestors came from Scandinavia and Norway. Those areas have MS levels similar to Montana's.

Nick Zelver of the MSU Technology Transfer Office said companies and entrepreneurs that want to license the MSU discovery should express their interest in writing to him by Jan. 31. They can contact him at (406) 994-7868, http://tto.montana.edu or at nzelver@montana.edu

To date, MSU has licensed 111 technologies developed by faculty, Zelver said. Seventy of those licenses are with Montana companies. To access these and other MSU technologies, visit: http://tto.montana.edu/technologies
Evelyn Boswell, (406) 994-5135 or evelynb@montana.edu

High levels of vitamin D in the body may decrease the risk of multiple sclerosis

Boston, MA – The possibility that vitamin D could help protect people from developing multiple sclerosis (MS) has been posited by researchers in recent decades, but evidence to support that link has been scant. 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. The study appears in the December 20, 2006, issue of the Journal of the American Medical Association.

"If confirmed, this finding suggests that many cases of MS could be prevented by increasing vitamin D levels. Although these levels could be increased by taking supplements, before any recommendation is made it is important to establish whether we are seeing a true causal association or whether vitamin D levels are only a marker of MS risk," said Alberto Ascherio, senior author of the study and associate professor of nutrition and epidemiology at HSPH.

MS is a chronic degenerative disease of the central nervous system. It affects some 350,000 people in the U.S. and 2 million worldwide, and occurs most commonly in young adults. Women, who are affected more than men, have a lifetime risk of about 1 in 200 in the U.S. Vitamin D is a hormone manufactured naturally in the body, and its levels can be increased with exposure to sunlight, consumption of foods rich in vitamin D, such as fatty fish, and by taking supplements.

The researchers, led by Ascherio, worked in collaboration with colleagues in the U.S. Army and Navy to determine whether vitamin D levels measured in healthy young adults predict their future risk of developing MS. The investigation relied on a study population of more than 7 million individuals, whose serum samples are stored in the Department of Defense Serum Repository. Between 1992 and 2004, 257 U.S. Army and Navy personnel with at least two serum samples stored in the repository were diagnosed with MS. A control group, consisting of participants who did not develop MS, was randomly selected from the study population. Serum samples were analyzed for levels of 25-hydroxyvitamin D, a good indicator of vitamin D availability to tissues, and individuals were divided into five groups of equal size according to their average levels. Because vitamin D levels are strongly influenced by skin color, separate analyses were conducted among whites, blacks, and Hispanics.

The results showed that, among whites, MS risk declined with increasing vitamin D levels--the risk was 62% lower among individuals in the top fifth of vitamin D concentration (corresponding approximately to levels above 100 nmol/L or 40 ng/mL) than among those in the bottom fifth (approximately below 63 nmol/L or 25 ng/mL). The association was strongest among individuals who were younger than 20 when they first entered the study. No significant association was found among blacks and Hispanics, possibly because of a smaller sample size and the lower levels of vitamin D found in those groups. The average age of onset of MS cases was 28.5 years old; there was no significant difference in the results between men and women.

"The results of this study converge with a growing body of experimental evidence supporting the importance of vitamin D in regulating the immune system and suppressing autoimmune reactions, which are thought by most experts to play a key role in the development of MS," said Ascherio. Kassandra Munger, first author and a doctoral candidate in nutrition at HSPH, added, "The amount of vitamin D that is needed to reach levels associated with MS protection is largely considered safe, and in fact higher vitamin D levels could be beneficial to prevent osteoporosis and other chronic diseases."

The researchers note that there could be other possible explanations for the protective role of vitamin D. For example, it’s possible that exposure to UV light from the sun--the major determinant of serum levels of 25-hydroxyvitamin D--could protect people in other ways than increased vitamin D production.

The authors suggest further studies exploring how vitamin D may protect individuals from developing MS. "Although the results of this study are quite encouraging, reasonable certainty of a protective effect of vitamin D supplements requires direct experimental evidence in a large trial. Meanwhile, we are planning to expand our study to obtain more accurate data on the importance of age and of the vitamin D levels that need to be achieved for optimal protection," said Ascherio.

###
The work was supported by grants from the National Institute of Neurological Disease and Stroke and by a pilot grant from the National Multiple Sclerosis Society.

Harvard School of Public Health is dedicated to advancing the public's health through learning, discovery, and communication. More than 300 faculty members are engaged in teaching and training the 900-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children's health to quality of care measurement; from health care management to international health and human rights. For more information on the school visit: www.hsph.harvard.edu

Stem Cells Found In Adult Hair Follicles May Provide Alternative To Embryonic Stem Cells

Science Daily — A team from the Medical College of Wisconsin in Milwaukee has applied for a patent on their work to isolate, grow and identify a new and readily-available type of adult stem cell that is found in the bulge of hair follicles, and appears to have a potential for diversification similar to that of embryonic stem cells.

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.

A report on the research from Dr. Maya Sieber-Blum's laboratory, co-authored by Yao Fei Hu, Ph.D., and Zhi-Jian Zhang, Ph.D., researchers in cell biology, neurobiology and anatomy at the Medical College, was published in a recent issue of Stem Cells: The International Journal of Cell Differentiation and Proliferation.

Epidermal neural crest stem cells are found in the bulge of hair follicles and have characteristics that combine some advantages of embryonic and adult stem cells, according to lead researcher, Maya Sieber-Blum, Ph.D., professor of cell biology, neurobiology & anatomy. Similar to embryonic stem cells, they have a high degree of plasticity, can be isolated at high levels of purity, and can be expanded in culture. Similar to other types of adult stem cells, they are readily accessible through a minimally invasive procedure and could lead to using a patient's own hair as a source for therapy without the controversy or medical issues of embryonic stem cells.

"We see the potential for cell replacement therapy in which patients can be their own donors, which would avoid ethical issues and reduce the possibility of tissue incompatibility," says Dr. Sieber-Blum.

The Medical College team in collaboration with Prof. Martin Schwab, director of the Brain Research Institute of the University of Zürich, recently injected these cells in mice with spinal cord injuries. According to the study, when grafted into the spine, the cells not only survived, but also demonstrated several desirable characteristics that could lead to local nerve replacement and re-myelination (restoration of nerve pathways and sheaths).

Neural crest stem cells generate a wide array of cell types and tissues and actually give rise to the autonomic and enteric nervous systems along with endocrine cells, bone and smooth muscle cells. The cells can be isolated from the hair follicle bulge as multipotent stem cells, and then expanded in culture into millions of cells without losing stem cell markers.

"We grafted the cells into mice that have spinal cord injuries and were encouraged by the results. The cells survived and integrated into the spinal cord, remaining at the site of transplantation and not forming tumors," Dr. Sieber-Blum says.
According to Dr. Sieber-Blum, subsets of the epidermal neural crest stem cells express markers for oligodendrocytes, the nerve-supporting cells that are essential for proper neuron function. She has been awarded a grant from the Biomedical Technology Alliance, a Milwaukee inter-institutional research group, to determine in collaboration with Brian Schmit, Ph.D., associate professor of biomedical engineering at Marquette University, if the grafts lead to an improvement of spinal reflexes in the injured spinal cord of mice.

Dr. Sieber-Blum points out that the cells may also be useful to treat Parkinson's disease, multiple sclerosis, Hirschsprung's disease, stroke, peripheral neuropathies and ALS. Certain defects of the heart, and bone defects (degeneration, craniofacial birth defects) could also be treated through neural crest stem cell replacement therapy. Together, these conditions affect over 11 million people today in the US and are estimated to annually cost more than $170 billion.

Note: This story has been adapted from a news release issued by Medical College of Wisconsin.

MultiCell Technologies Fulfills Upfront License Fee Payment Obligation to Amarin Neuroscience for MCT-125

MultiCell Technologies, Inc. (OTCBB:MCET), developing first-in-class drugs based on advanced immune system modulation and other proprietary technologies, today announced that the Company has completed payment of all upfront license fees related to its acquisition of MCT-125, a breakthrough drug candidate being developed as a treatment for primary chronic fatigue associated with multiple sclerosis (MS).

The payment was completed pursuant to the terms of the amended license agreement with Amarin Neuroscience Ltd. MultiCell estimates MCT-125 could generate up to $3 billion in cumulative worldwide sales during the time MCT-125 is under patent protection. If such revenue forecasts are realized by MCT-125, under the terms of the agreement, Amarin could receive up to $275 million in milestone payments and cumulative royalty payments during the same period.

“MCT-125 is one of our leading therapeutic candidates because it promises to be among the first treatments for the debilitating effects of chronic fatigue caused by multiple sclerosis,” said Dr. Stephen M. Chang, Chief Executive Officer of MultiCell Technologies.

MCT-125 targets fatigue associated with MS, an autoimmune disease in which immune cells attack and destroy the myelin sheath protecting neurons in the brain and spinal cord. About two million people worldwide are afflicted with MS, and approximately 70 percent of them report fatigue as the worst symptom of their disease.

In a 138 patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the UK by Amarin, MCT-125 (then known as LAX-202) demonstrated efficacy in significantly reducing the levels of fatigue, with few if any side effects, in all MS patient populations enrolled in the study including relapse-remitting, secondary progressive and primary progressive.

About MultiCell Technologies, Inc.

MultiCell Technologies, Inc. is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technology. MultiCell’s drug development program is focused on modulation of the immune system.

MultiCell’s therapeutic pipeline includes drug candidates some of which are in various advanced stages of human clinical trials. These therapies include:

* MCT-125 for the treatment of chronic fatigue in MS patients. MCT-125 completed a Phase II clinical trial and demonstrated significant efficacy in reducing chronic fatigue in MS patients. There is no drug specifically approved for the treatment of chronic fatigue in MS patients anywhere in the world.

* MCT-175 for the treatment of relapsing-remitting MS. MCT-175, in preclinical development for the treatment of relapsing-remitting MS, targets disease specific autoaggressive T-cells that destroy the myelin sheath of nerve cells. MCT-175 successfully ameliorated the disease in animal models.

* MCT-275 for the treatment of type-1 diabetes. MCT-275, in preclinical development, targets disease-specific autoaggressive T-cells that destroy insulin producing cells in the pancreas. MCT-275 completely reversed the type-1 diabetic phenotype and prolonged life in animal models.

* MCT-465 in an adjuvant therapy for the treatment of virus infection and cancer. MCT-465 in preclinical studies successfully reduced pulmonary influenza virus levels 1,000-fold in animal models, and has demonstrated effectiveness in reducing virus levels of HIV and HCV in animal models. MCT-465 in preclinical studies successfully eliminated certain types of tumors in animal models.

The Company also holds unique cell-based technology for use in drug discovery screening applications, and is a leading producer of the cell lines needed by the biotechnology industry to develop new drugs and therapeutics.

For more information about MultiCell Technologies, please visit www.multicelltech.com. For investor information about MultiCell, please visit www.trilogy-capital.com/tcp/multicell.

Botox is gaining respect as medication

BY DEBBE GEIGER
Special to Newsday

December 19, 2006

Botox may have risen to fame on its ability to freeze frown lines and make wrinkles temporarily disappear.

But when used properly by trained professionals, doctors say, botulinum toxin - sold under several brand names including Botox, MyBloc, Dysport and NeuroBlock - can be a versatile therapy for a range of medical conditions.

It is not always the first treatment of choice for these conditions, according to medical reports, but it can be surprisingly effective, say doctors familiar with it, and might someday have even broader uses.

"People who don't know anything about it have this impression of what Botox is," says Dr. Anthony Geraci, a neurologist at Lutheran Medical Center in Brooklyn, who is studying Botox in stroke patients. "It's received a bad rap. The reality is that it's an incredible medicinal."

Years before receiving FDA approval to smooth facial lines, Botox had already been approved to treat crossed eyes and uncontrollable eye blinking. It's also approved for head and neck pain associated with an involuntary movement disorder known as dystonia.

Two years after it gained fame as a wrinkle reducer, Botox received FDA approval for the treatment of excessive underarm sweating. Today, studies are under way to evaluate its ability to reduce headache and chronic migraine pain, alleviate muscle stiffness and control overactive bladders.

It also has been studied in patients with tennis elbow and tinnitus, or ringing in the ears, although initial reports say more evidence is needed to prove its effectiveness for those conditions.

"Botox works by temporarily relaxing muscles, and by blocking the release of certain substances that cause pain," says Dr. Robert Duarte, director of the Long Island Jewish Pain and Headache Center in Manhasset. Aside from possible injection discomfort, there are few to no reported side effects, he said.

"I've been working with Botox for 10 years," says Geraci, who uses it to treat patients who have stiffness from stroke, spinal cord diseases, traumatic brain injury and multiple sclerosis. "I became interested in it because of its ability to relax muscles in a very targeted fashion. One of the big problems we have when we treat patients is that all the medications made them sleepy and have other bad side effects. I can put this medication into the muscles and affect relaxation without any systemic side effects. It's really safe."

Sharon Roth, 48, of Roslyn Heights has been receiving Botox injections to fight her chronic, daily migraines for the past three years, about four times a year. "I tried every medication on the market for migraines, and nothing worked."

Once she started receiving injections in her forehead, temple and neck, she felt different almost immediately. "At first it feels like you have duct tape on your head. Then I feel relief. My migraines are less severe, and I don't have to take my medication as much. I went from being incapacitated in bed in a dark room to being able to function while still having pain."

Nevertheless, Duarte cautioned that patients considering Botox should consult a specialist in their condition. And insurance may cover only an FDA-approved use of the drug.

Multiple Sclerosis Is the Most Common Cause of Neurological Disability in Young Adults in the UK

December 19, 2006 10:30 AM Eastern Time

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/reports/c47292) has announced the addition of Espicom Business Intelligence’s CNS Drug Discoveries: Multiple Sclerosis Chapter to their offering.

The incidence of multiple sclerosis varies throughout the world, although there is a significantly higher incidence of the disease found in the Northern Hemisphere. Find out more in this chapter of CNS Drug Discoveries.

It is estimated that over 350,000 Americans (approximately 1 in 1,000 aged over 30 years) live with multiple sclerosis (MS) and approximately 3 million live with it worldwide. However, the prevalence may be higher because of the uncertainty in diagnosing the condition. Women are twice as susceptible as men and it is more common in people in northern latitudes over the age of 18 years. In addition, siblings of an individual with multiple sclerosis have a higher chance of developing the disease.

The incidence of multiple sclerosis varies throughout the world, although there is a significantly higher incidence of the disease found in the northern hemisphere. Multiple sclerosis is the most common cause of neurological disability in young adults in the UK.

It is variable in presentation and progression. Although there is no cure, there are many symptomatic treatments available. However, many patients do not respond to currently available products (30%) and the more chronic forms (secondary-progressive MS) are poorly treated with existing therapies.

Global multiple sclerosis market

The MS market is estimated to be worth US$4.9 billion in 2006 with a growth rate of 8.9% year-on-year. It is the fifth largest segment of the CNS market and has attracted considerable R&D investment from big pharma, biotechnology companies and specialty pharma. The market is currently driven by the use of six disease-modifying agents: Avonex (Biogen Idec), Betaseron/Betaferon (Schering AG), Copaxone (Teva), Novatrone (Schering AG), Rebif (Serono/Pfizer) and Tysabri (Biogen Idec/Elan).

Sales growth will be driven by current drugs gaining broader indications, MS medicine being prescribed earlier in treatment in clinically-defined multiple sclerosis patients and the longer-term use of combination therapies as more classes of drug become available.

Key questions answered in this chapter include:

-What are the 5 leading products in the US, Europe and Japan?

-What will the shape of the market be in 2012?

-How will Biogen Idec defend its market leading position from Serono, Schering AG and Teva?

-What role will combination therapies play?

-What opportunities are there in the treatment of primary-progressive multiple sclerosis?

-What are the prospects for drugs in development such as Campath, Mylinax, and laquinimod?

Content Outline:

MULTIPLE SCLEROSIS

EXECUTIVE SUMMARY

THE FACTS

PATIENT STATISTICS

PATIENT MODEL

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

GLOBAL MS MARKET

GLOBAL SALES SPLIT

CURRENT TREATMENTS

ANALYSIS OF LEADING BRANDS

Disease-modifying agents

GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005–2012

NEW DRUGS IN R&D

ANALYSIS OF PHASE III DRUGS

MS Symptoms

GLOBAL SALES FORECASTS OF PHASE III MS DRUGS 2006–2012

ANALYSIS OF PHASE II DRUGS

Disease-modifying agents

Vaccines

GLOBAL SALES FORECASTS OF PHASE II MS DRUGS 2006 – 2012

COMPETITOR RATIO ANALYSIS - PRODUCTS

COMPETITOR RATIO ANALYSIS - COMPANIES

DISCONTINUATION OF DRUGS

MS APPENDIX 1

MS APPENDIX 2

MS APPENDIX 3

MS APPENDIX 4

MS APPENDIX 5

Ms APPENDIX 6

MS GLOSSARY

MS REFERENCES

ACRONYMNS

For more information visit http://www.researchandmarkets.com/reports/c47292

Contacts
Research and Markets
Laura Wood
Senior Manager
Fax: +353 1 4100 980
press@researchandmarkets.com

Warning Given On Drug's Use To Treat Lupus

New York Times Full Feed - Dec. 19, 2006

Biogen Idec and Genentech have warned doctors of two deaths among patients receiving the cancer drug Rituxan as a treatment for the autoimmune disorder lupus.

The medicine, used to treat patients with non-Hodgkin's lymphoma and rheumatoid arthritis, is not approved as a therapy for lupus, Biogen, based in Cambridge, Mass., said yesterday in a regulatory filing. The patients developed a rare brain infection called progressive multifocal leukoencephalopathy, or P.M.L., the companies said.

Rituxan's prescribing information already includes a warning about P.M.L. for cancer patients taking the drug. The infection is also a risk of Biogen's multiple sclerosis drug Tysabri, which was withdrawn from the market in 2005 because of three cases of the disease, which has no treatment and is usually fatal. It was reintroduced last July after Biogen adopted a new safety program for the drug. The companies are also testing Rituxan as a multiple sclerosis treatment.

''This might make it more challenging to develop Rituxan in M.S. and lupus,'' Eric Schmidt, an analyst with Cowen & Company in New York, said in a telephone interview. ''Even though we can't necessarily link this to Rituxan, it's an unfortunate circumstance.''

The Food and Drug Administration posted a public health advisory on its Web site about the two deaths.

Biogen shares, after closing at $50.23 on Nasdaq yesterday, fell $2.69, or 5.3 percent, to $47.54 in after-market trading. Genentech shares, after closing at $80.96 on the New York Stock Exchange, fell $1.46 in after-hours trading, or 1.5 percent, to $79.50. Genentech, based in South San Francisco, Calif., markets the drug with Biogen in the United States. Roche Holding, based in Basel, Switzerland, sells Rituxan in Europe under the name Mabthera.

Since its approval in 1997, Rituxan has been linked to 23 cases of P.M.L. among patients with non-Hodgkin's lymphoma, a cancer of the lymphatic system, said Tim Hunt, a Biogen spokesman.

The infection is a known risk in patients whose immune systems are suppressed because of their diseases or the drugs they are taking, the companies said.