Betaferon® approved in China for treatment of Multiple Sclerosis

Bayer Schering Pharma AG announced that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010.

Betaferon is available in more than 100 countries around the world. "This approval is good news for MS patients in China, allowing them access to Betaferon, that has been demonstrated to modify the course of MS," said Habib Dable, Global Head, Neurology/Ophthalmology of Bayer Schering Pharma AG. "The approval of Betaferon in China underscores Bayer's ongoing commitment to address the unmet medical needs of people around the world.

A study led by a Scripps Research Institute scientist describes a new, highly pragmatic approach to the identification of molecules that prevent a specific type of immune cells from attacking their host. The findings add a powerful new tool to the ongoing search for potential treatments for autoimmune diseases, such as multiple sclerosis (MS), as well as blood cancers, such as myeloid leukemia.

The study by Thomas Kodadek, a professor in the Chemistry and Cancer Biology Departments at Scripps Florida, and colleagues was published in the journal Chemistry & Biology. In the new study, Kodadek and his colleagues used samples from an animal model of multiple sclerosis to screen for T cells -- a type of white blood cell that plays a central role in the immune system -- with a heightened presence in the disease. The screen also identified molecules that interfere with these T cells' "autoreactivity," in other words, their attack on the body itself rather than a foreign invader such as virus or bacteria.

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"Our technique simultaneously uncovers and isolates autoreactive T cells as well as inhibitors to them," Kodadek said. "It's a double whammy. At the heart of this is a comparative screening process of normal T cells versus disease-causing T cells. While the process is technically complicated and difficult, the thinking behind it is not. We wanted to simplify the process of identifying compounds that could inhibit autoreactive T cells with exceptional specificity, and we succeeded."

The scientists used a model of MS, an autoimmune inflammatory disease affecting the brain and spinal cord, for the study. In MS, the immune system attacks the myelin sheath covering and protecting nerve cells, leading to a variety of symptoms depending on which part of the nervous system is affected. Common symptoms of the condition include fatigue; numbness; walking, balance, and coordination problems; bladder and bowel dysfunction; vision problems; dizziness and vertigo; sexual dysfunction; pain; cognitive problems; emotional changes; and spasticity.

Simplifying the Process

In setting up the new method to shed light on such autoimmune diseases and other disorders, Kodadek and his colleagues created a large collection of peptoids -- molecules related to, but more stable than, the peptides that make up proteins. By arranging thousands of peptoids on a microscope slide, the pattern of binding antibodies (a type of immune molecule) and peptoids can be visualized. By looking at samples from animal models of a known disease like MS, peptoids that bind to antibodies closely associated with that disease can be easily recognized. Better still, peptoids that bind to autoreactive T cells can be identified without knowledge of the specific antigen (molecule triggering the immune attack), providing an unbiased method with which to search for potentially useful compounds.

Most autoimmune research has focused on finding the disease-causing antigens first, Kodadek said, a Quixote-like quest that has lasted more than four decades with little success to show for it. "With our process, it doesn't really matter what the antigen is," said Kodadek, a 2006 recipient of the National Institutes of Health Director's Pioneer Award, which is designed to support individual scientists of exceptional creativity. "That was really the breakthrough. We're setting up a system that recognizes T cell receptors that are very abundant in a sick animal and at low levels in a healthy animal. Why the abundance? Because that's what making them sick."

Potential for Therapeutic Discovery

The new process creates new potential for therapeutic discovery. Molecules that target autoreactive T cells directly, while ignoring those T cells that recognize foreign antigens, could serve as the foundation for a novel drug development program aimed at eradicating autoreactive cells without affecting the normal function of the immune system. "Almost without exception, drugs currently used to treat autoimmune conditions either inhibit something downstream of the autoimmune response itself, like inflammation, or they moderate the immune system non-selectively and that results in significant side effects," Kodadek said.

However, the new study isn't the final answer, according to Kodadek. He noted that the recent study used a model of MS triggered by a single antigen. In humans, there could be two -- or two dozen -- antigens triggering an autoimmune disease such as MS. This calls for further research. The method may be more easily applied to blood cancers, though, since the disease-causing T cells have been fully characterized and there are very few of them.

Source: ScienceDaily © 1995-2009 ScienceDaily LLC (01/12/09)

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Multiple Sclerosis progress slowed by giving birth, Belgian doctors say

Giving birth seems to slow the progression of multiple sclerosis (MS), Belgian and Dutch researchers say. The researchers tracked 330 women with MS for 18 years and found that among those who had children, severe disability took longer to develop.

Writing in the Journal of Neurology, Neurosurgery and Psychiatry, they say previous studies have suggested a worsening of MS just after birth. But the MS Society said the study was flawed and further research was needed. MS is a long-term inflammatory condition of the central nervous system. It affects the transfer of messages from the nervous system to the rest of the body. Women are twice as likely to develop MS as men and many of the new cases will be among women of childbearing age.

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The researchers from Belgium and the Netherlands said all the women had been referred to one specialist centre and had had their first symptoms from the ages of 22 to almost 38. Nearly a quarter of the women (24%) were childless; 170 had given birth before their symptoms developed (52%); 61 had their children after their symptoms developed (18%); and 19 had had children both before and afterwards (6%).

'Speed of progression'

The researchers used the Kurtzke Expanded Disability Status Scale (EDSS) which runs from one to 10, where 10 is death from MS and six is when an individual needs a cane, a crutch or a brace to walk 100m. After an average of 18 years living with MS, over half the women (55%) were categorised as EDSS six. They found that both the likelihood and speed of progression were affected by childbirth.

Women who had given birth to one or more children at any point before or after the start of MS symptoms were 34% less likely to progress to EDSS six than childless women. Women whose children had been born after their MS began were 39% less likely to progress to EDSS six than women who had not had children. They said this held true even after taking account of the age at which symptoms began. Women who had no children after their MS symptoms started progressed to EDSS six within 13 to 15 years on average. But women who did have children took an average of 22 to 23 years to reach this stage.

'Beneficial effect'

Dr Maria D'hooghe, from the National MS Centre in Melsbroek, Belgium, which co-ordinated the study, said it had shown for the first time the long-term effects of having a baby if you have MS. She said: "It's possible that the hormones released in pregnancy are having a beneficial effect on the immune system.

"Certainly, animal studies show that pregnancy can lead to less damage in their brains. "The other possibility is that it is lifestyle changes caused by having a baby that are delaying the effects of MS perhaps through increased activity or changes in the way we deal with stress."

But Dr Susan Kohlhaas, research communications officer for the MS Society, said it was a small study and they had not taken account of the fact that women with more severe MS may choose not to get pregnant because they are worried about a relapse or about taking care of a baby during a relapse. She said: "It is difficult to form any meaningful conclusions from this research given the small size of the study and its flaws, but further studies will hopefully clarify the effects of pregnancy in women with MS."

Source: BBC News © British Broadcasting Corporation 2009 (24/11/09)

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Vitamin D - the missing link for multiple sclerosis sufferers

Scientists have uncovered increasing evidence of the significance of Vitamin D in the development of multiple sclerosis. Now, Australian researchers have found that Vitamin D may actually reduce its symptoms.

Professor Bruce Taylor, a principal research fellow at the Menzies Institute in Hobart, studied 145 patients in southern Tasmania and tracked their seasonal susceptibility to the disease. He looked at how Vitamin D levels influenced their risk of having an attack of MS. 'We found that the higher your Vitamin D level, the lower your chance of relapse, and for each ten nanomole [a standard measure of concentration of Vitamin D in the blood] increase in Vitamin D, you can reduce your risk of having an attack of MS by about ten per cent. Doubling your Vitamin D will reduce your risk by up to 50 per cent - a major result.'

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Helen Yates, the Multiple Sclerosis Resource Centre's chief executive, says: 'It has long been believed that Vitamin D has a role to play in the risk of developing MS but this new research opens up the strong possibility that this vitamin could impact on relapse rates.' The MS Society's research communications officer, Dr Susan Kohlhaas, says: 'These results are very early-stage and need to be reviewed and validated before we draw any firm conclusions.'

It has been known for many years that the further you live from the Equator, the more likely you are to develop MS. For example, Malaysia has hardly any sufferers but in Scotland and Scandinavia MS is relatively common. It is believed this is due to a shortage of Vitamin D; countries far from the Equator, such as those in Northern Europe, enjoy less sunshine, the main source of Vitamin D.

Research has shown that babies born in May - who developed in the womb during the Vitamin D-scarce winter months - are the most likely to get MS in later life, while those born in November are at much lower risk. Another study this year found evidence that Vitamin D deficiency during pregnancy and infancy could increase a child's risk of developing MS in later life.

The researchers concluded that taking Vitamin D supplements during these times could reduce the risk, although this has yet to be proven.

Source The Mail Online © 2009 Associated Newspapers Ltd (22/11/09)

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Fifty percent of MS patients avoid treatment over injectable delivery fears

Around half of all multiple sclerosis (MS) patients that are eligible for treatment do not receive it and one in five of those patients that do begin therapy, delay doing so because of fear and anxiety over the treatment process, and not fear and anxiety about the disease.

These observations are according to Patricia Kennedy, a nurse practitioner and consultant at Can Do Multiple Sclerosis, formerly The Heuga Center for MS, US, who presented at the 2nd Vetter Drug Management Leadership Conference in Germany. If the injectable therapies that we have available today are good for MS, good for patients, and good for the future, why aren't patients taking them? questioned Kennedy. It is important for industry to be aware of MS patients' reasons for avoiding treatment and what they go through when facing the disease, she added. She then urged delivery-device manufacturers to consider patient behaviour and feelings when developing new devices in order to increase a patient's chances of initiating therapy and complying with long-term treatment.

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According to Kennedy, healthcare professionals face a number of challenges when dealing with MS patients, with those who are eligible for therapy opting out of treatment for a number of reasons, including: lack of belief that it is needed; fear of needles; the constant reminder of the disease each time they need to inject; lack of family support; and the financial burden of treatment.

Even in those patients that do begin treatment, it's another challenge to keep them on it, admitted Kennedy. She also advised of the problems that US healthcare systems currently face with disposal of syringes and sharp objects; this is a particular problem in more populated regions in the US. Education of patients and their support networks is incredibly important to help with patient compliance and disease management. However, Kennedy also provided advice to industry on how new device development might help MS patients to manage and control their disease since injection-related issues are still a primary cause for patient's fear of starting therapy and is the main reason for lack of compliance.

What can industry do?

The easier we can make it for a patient to administer treatment, the more likely it is that the medication is going to be used, explained Kennedy. In most cases, the smaller the needle, the better. Although a 29-gauge needle might be easier to use than a 30-gauge needle, and although both are small, the patient will opt for the slimmer 30-gauge every time. Psychologically, that's what they want, she added.

According to Kennedy, patients want titrated, prefilled syringes that are marked clearly. Not only does this avoid any issues of efficient mixing and incorrect dosing, but MS patients often have vision problems. Kennedy also emphasized the importance of travel devices, such as pens. Patients want devices that are easy to travel with because we live in a mobile society, and if we provide the option of transporting less bulky injections devices whilst they're away from home, patients are more likely to comply with their medication, she advised.

In general, Kennedy also believes that injection devices could help patients immensely. Most patients like injectors; even if the needle is a 30-gauge needle, patient's don't want to see it. So if you can hide the injector, then that's good. It's psychological, she said. Injection devices not only help overcome the psychological barrier to injections, but they are also easier to use than syringes, which is especially beneficial for those patients that suffer from tremors. In addition, they help patients to obtain a consistent depth of injection and thus reduce the number of injection-related side effects.

I also believe that needless devices would help improve patient compliance with drug therapy, added Kenney. The bottom-line for patients, according to Kennedy, is to provide them with delivery devices that are easy to use, offer choice and flexibility, with increased comfort. What patients really want, first of all, is control over their MS; easily-injectable systems can help with that. They want to be self-effective, they want a medication that's easy to use because then they're not reminded about their MS, and if they're reminded less often then life goes on and they're able to pursue other things.

So in the future, I would urge industry to continue to make injectable devices that are more patient-friendly. We need to work together to decrease the number of non-users; let's raise that 50% to 75%, she insisted. I doubt we'll ever make 100%, but we can lessen the impact of MS on a person's life by giving them maximum control and letting them get on with their life. If we treat people early with the medications, we already have available to us today, and treatment is consistent and easy to administer, it gives them hope for the future, she concluded.

Source: Pharmatech.com © 2009 Advanstar Communications, Inc (20/11/09)

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Drug studied as possible treatment for spinal injuries might also treat Multiple Sclerosis

Researchers have shown how an experimental drug might restore the function of nerves damaged in spinal cord injuries by preventing short circuits caused when tiny "potassium channels" in the fibers are exposed. The chemical compound also might be developed as a treatment for multiple sclerosis.

Because nerves usually are not severed in a common type of spinal cord trauma, called "compression" injuries, the drug offers hope as a possible treatment, said Riyi Shi, a professor in Purdue University's Department of Basic Medical Sciences, School of Veterinary Medicine, Center for Paralysis Research and Weldon School of Biomedical Engineering.

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"Compression is responsible for most spinal cord injuries, including many resulting in paralysis," Shi said. "Since the nerves are not severed, this type of drug represents a potential golden opportunity to treat spinal cord injuries." The experimental compound, 4-aminopyridine-3-methyl hydroxide, has been shown to restore function to damaged axons, slender fibers that extend from nerve cells and transmit electrical impulses in the spinal cord.

Findings, based on experiments with guinea pig spinal cord tissue, appeared online in the Journal of Neurophysiology. The work was led by Department of Basic Medical Sciences doctoral student Wenjing Sun. Shi said the findings were made possible by the interdisciplinary nature of the work, which also involves researchers Richard Borgens, director of Purdue's Center for Paralysis Research and the Mari Hulman George Professor of Neurology in the School of Veterinary Medicine; Stephen Byrn, the Charles B. Jordan Professor of Medicinal Chemistry, and Daniel Smith, a research assistant professor, both in the Department of Industrial and Physical Pharmacy; and Ji-Xin Cheng, an associate professor in the Weldon School of Biomedical Engineering and Department of Chemistry.

Researchers have shown how an experimental drug might restore the function of nerves damaged in spinal cord injuries by preventing short circuits caused when tiny "potassium channels" in the fibers are exposed by trauma. The compound also might be developed as a treatment for multiple sclerosis. This diagram illustrates how the drug functions as a "channel blocker," meaning it permits the conduction of signals even though the protective myelin insulation has been damaged.

The researchers subjected spinal cord tissue to stresses that mimic what happens in a compression injury, which stretches nerves. Then they treated the damaged axons with 4-aminopyridine-3-methyl hydroxide. The compound is a derivative of the drug 4-aminopyridine, used primarily as a research tool and also to manage symptoms of multiple sclerosis. The axons of each nerve are sheathed in a thick insulating lipid layer, called myelin, which enables the transmission of signals without short circuiting, much like the insulation surrounding electrical wires.

Spinal cord trauma damages the myelin sheath, exposing "fast potassium channels" that are embedded in the axons and are critical for transmitting nerve impulses. The researchers confirmed previous circumstantial evidence suggesting injury causes the myelin insulation to recede, exposing the channels and impairing signal transmission. Laboratory and imaging techniques revealed the exposed channels in damaged axons. The researchers also discovered that 4-aminopyridine-3-methyl hydroxide is a "potassium channel blocker," using a sophistic laboratory technique called "patch clamp" to measure signal conduction.

Findings confirmed that the compound prevents the exposed channels from leaking electrical current and enhances nerve conduction in segments of the damaged spinal cord. The compound could make it possible to sidestep spinal cord damage by enabling axons to transmit signals as though they were still sheathed in myelin, Shi said. Nerves transmit signals through a series of rapid electrical pulses, or "action potentials." For proper nerve function, the time gap between pulses must be as brief as possible. However, 4-aminopyridine has been shown to lengthen the gap, or "refractory period," between pulses.

The researchers found that 4-aminopyridine-3-methyl hydroxide restores function without affecting the refractory period. As a result, the damaged nerves perform more like healthy nerves than those treated with other drugs, he said. Another key advantage of the new compound is that it's about 10 times more potent than 4-aminopyridine, meaning lower doses can be used to reduce the likelihood of serious side effects.

Because myelin also is damaged in multiple sclerosis, the same drug might be used to restore nerve function in people stricken with the disease, Shi said. Since the newer drug can be used in lower doses, it might be more effective than 4-aminopyridine in treating multiple sclerosis, which affects more than 350,000 people in the United States and 2.5 million worldwide, he said.

Source: Science Codex (20/11/09)

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Three more PML cases and one more death confirmed for Multiple Sclerosis drug Tysabri

It was confirmed yesterday, 18/11/09, by a Biogen Idec spokesperson that there had been a further 3 reported cases of progressive multifocal encephalopathy (PML) in patients taking the multiple sclerosis drug Tysabri. It was also confirmed that one further patient has died of the serious brain infection.

To date 63,000 patients have taken Tysabri since it was returned to the market in July 2006, of which 27 have developed PML and 5 of these have died. Based on these evolving figures, the FDA updated the Tysabri prescribing information earlier this month to say that the risk appears to increase as patients stay on the drug for longer periods of time. Questions are being asked as to what is happening to those patients who get PML, but survive.

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Biogen confirmed that it isn't releasing a patient-by-patient breakdown of what is happening to the survivors, but its medical affairs staff is answering those questions from doctors. It is reported by Biogen that some of the patients are severely disabled, but a few of the 27 cases have recovered and some have even return to work.

Commenting on this latest report, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, "It is always distressing and worrying to hear of further cases of PML in patients that have been receiving Tysabri. It is even more of a concern to hear that one of the patients has died as a result of PML when the monitoring process is supposed to alert the medical professionals to the possibility of PML much earlier than previously. We keep being told that PML is becoming more treatable and yet Biogen are not releasing information clearly to the people who are considering this treatment thus leaving them unsure as to the genuine risk they are facing. Tysabri is, without doubt, proving extremely effective for many people but nevertheless patients should be provided with all relevant information when weighing up the risk against efficacy of this drug"

Source: MSRC & Xconomy Boston © 2007-2009, Xconomy, Inc (19/11/09)

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MS is more aggressive in children but slower to cause disability than in adults

Magnetic resonance images (MRI) of patients diagnosed with multiple sclerosis in childhood show that pediatric onset multiple sclerosis is more aggressive, and causes more brain lesions, than MS diagnosed in adulthood, researchers at the University at Buffalo have reported. Interestingly, however, patients with pediatric-onset MS -- which comprise up to 5 percent of total MS cases -- develop disabilities at a slower pace than patients with adult-onset MS, the data showed.

"Patients with pediatric-onset MS have three times as many relapses annually than patients with adult-onset disease, which suggests there is greater disease activity in this population," said Bianca Weinstock-Guttman, MD, associate professor of neurology in the UB School of Medicine and Biomedical Sciences and corresponding author. "But surprisingly, the average time to reach the secondary progressive phase of the disease is longer in patients who develop MS in childhood than in adult onset MS," she continued. "Reaching the next stage of disability is almost 10 years longer in pediatric-onset patients."

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Weinstock-Guttman directs the Pediatric Multiple Sclerosis Center of Excellence located at Women and Children's Hospital, and the William C. Baird MS Center in Buffalo General Hospital (BGH), both Kaleida Health affiliates and UB teaching hospitals. Eluen A. Yeh, MD, UB assistant professor of neurology and co-director in the Pediatric Multiple Sclerosis Center, is first author on the study, which was published online Nov. 5 in Brain. The National Multiple Sclerosis Society estimates that 8,000 to 10,000 children (defined as up to 18 years old) in the U.S. have multiple sclerosis, and another 10,000 to 15,000 have experienced at least one symptom suggestive of MS. The disease causes demyelination -- destruction of the sheath that protects and insulates nerve fibers. Breaks in the myelin sheath disrupt the flow of electrical impulses, causing loss of sensation and coordination.

The UB study involved four sets of patients:

* 17 children with an average age of 13.7 who were diagnosed with MS 2.7 years earlier

* 33 adults with an average age of 36.5 years who were diagnosed with pediatric MS 20 years earlier

* 81 adults with an average age of 40 who have had MS for an average of 2.6 years

* 300 adults with an average age of 50.5 who've had MS for 20 years

All participants underwent a brain MRI scan at facilities at BGH and at Women and Children's Hospital, while the specific MRI metric analysis was performed at the Buffalo Neuroimaging Analysis Center (BNAC), part of the UB Department of Neurology/Jacobs Neurological Institute, located in BGH. Robert Zivadinov, MD, PhD, UB associate professor of neurology, is director of the BNAC.

The MRI measured two types of brain tissue damage: T1-lesion volume, which shows "black holes," or hypointense lesions, which are areas of permanent axonal damage; and T2-lesion volume, which shows the total number of lesions (lesion load) and overall disease burden. Both of these measures indicated that MS is more aggressive in children in the early stages, said Yeh. "This corresponds with recent data that suggest a higher lesion burden in pediatric MS than adult-onset MS.

These findings are somewhat surprising, considering we have assumed that children generally have a greater capacity for central nervous tissue repair." "Our findings, which are limited to a cross-sectional study design, suggest that children have a somewhat better reserve and functional adaptability than adults, but less support for a better remyelination process," added Weinstock-Guttman. "However, the remyelination process may require a more in-depth prospective analysis" Weinstock-Guttman said the data support the need for early diagnosis and therapeutic intervention in pediatric MS patients.

Murali Ramanathan, PhD, associate professor in the departments of Pharmaceutical Sciences and Neurology in the UB School of Pharmacy and Pharmaceutical Sciences and School of Medicine and Biomedical Sciences, respectively, also contributed significantly to the research. Additional contributors were Jennifer L. Cox, PhD, research assistant professor and BNAC's director of neuroimaging, and neurology research assistants Deepa Preeti Ramasamy and Laura M. Willis. The research was supported in part by grants from the National Multiple Sclerosis Society and Children's Guild Foundation of Buffalo. Source: Insciences Organisation Copyright Insciences Organisation 2009 (17/11/09)

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Possible stop to Multiple Sclerosis could be just one trial away, however, pharmaceutical companies not interested

An Utah woman is about to begin a medical journey that she hopes will save her life. Michelle Colledge has Multiple Sclerosis, a disease that causes paralysis, blindness, and sometimes death. Johns Hopkins is testing a new treatment for this debilitating disease that so far, is dramatically effective. Michelle Colledge has been accepted as part of the study of this new and very aggressive treatment.

Michelle was diagnosed on Valentines Day 2007. She says, "The only way to describe those first couple of months was absolute terror, and crying at night for several hours, and just thinking my life was over." The young mother developed lesions on her brain and spine, her own immune system, charged with protecting her, had turned against her and become the enemy. Dr. Adam Kaplin, M.D. from Johns Hopkins explains; "What these people have, are these periods of time where their brains, spinal cords and their optic nerves are under attack ." He says no one knows why it happens, but doctors believe the immune system is tricked in reaction exposure to bacteria, viruses, or even a vitamin D deficiency.

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Michelle can't pinpoint a trigger for her MS, but she says each attack takes away the ability to live a normal life. "When I say attacks, I am not talking about, oh, I woke up and I wasn't feeling well. I lost something. I would stop being able to walk, or I would lose my eyesight." She has regained those abilities, but the MS has taken its toll on her balance, she has lost feeling in her hands, and they shake, making it difficult to hold objects, or her own daughter. "My daughter is four years old and I don't know if she will ever know who her mom is. She may just see what the disease has left behind." But because Michelle's MS is progressing so rapidly, there is new hope. She has been selected for a clinical trial that could dramatically change her life, and the lives of everyone battling Multiple Sclerosis.

Johns Hopkins has found a way to erase a faulty immune system. Dr. Kaplin says it's a little like what you do to a computer. "It resets the immune system. We think of it as kind of the control, alt, delete of the immune system." Michelle will undergo intense chemotherapy using a strong drug developed decades ago. Dr. Kaplin says "We use it at 14 thousand milligrams, in one treatment, over the course of four days." And when it's over Michelle's old immune system will be gone, and so will her MS. "You watch the patients white blood cell count go to zero, and then something amazing happens, which is their cells start to repopulate and eventually the white blood cells come back to normal."

Patients are given an additional medication that along with the chemo, puts them into long term remission. So far, out of 40 patients who have participated in the study, 90 percent have shown no signs of the disease one to three years after their treatment. For some, the symptoms of MS have also disappeared. "We had one individual who needed a walker to get around and he now runs five miles every morning."

Michelle is nervous to begin the journey to living MS free, but she's excited about what it will mean to her and her family, as well as others who battle the disease. "This is a chance for me and it should not stop with me." Unfortunately, it could. Michelle believes she is the last patient accepted into the second of Johns Hopkins clinical trials, and it may be the last.

Dr. Kaplin says that although the first two trials were exceedingly promising, and no side effects were reported, outside of the usual reactions associated with Chemotherapy, there may be no more opportunity to test what could prove to be the cure for MS and other autoimmune disorders. "We need to do a randomized clinical trial, a much larger trial ,between 150 and 300 patients. It's a very expensive process. We need 15 million dollars to get this done." Without the trial, there can be no FDA approval, and insurance companies will not cover the cost of the treatment.

"We have gone to three different pharmaceutical companies and we have showed them the data, and asked them if they would be willing to get involved in this. We've had the same response from all of them. They all said it's an amazing treatment, we have seen nothing like it, this might one day lead to a cure for MS, if we could refine it. They say its fabulous, but we don't think we could recoup our investment, so it's not for us."

The problem Dr. Kaplin explains, is the drugs used in combination in this new treatment are decades old, cheap, and the patents have expired. This means, it is difficult for pharmaceutical companies to make a profit. Johns Hopkins has started a grass roots campaign to try to raise the money.

Source: ABC 4 News Copyright 2009 Newport Television LLC (16/11/09)

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As England ended the 2007 Rugby World Cup in Paris in defeat, sports commentator Alastair Hignell breathed a sigh of relief - and not at the result. He was bone-tired after a gruelling series of matches. A former England rugby player himself - as well as a first-class cricketer - he knew his body well enough to know it was time to quit.

Despite his diagnosis with multiple sclerosis (MS) in 1999, he had flourished in his second career as a commentator. But now the disease had progressed so far he could no longer do the job justice. However, far from being bitter about his fate, Alastair says he feels "blessed" to have experienced the world from such radically different perspectives.

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"I was finding it increasingly difficult to build up the energy needed to do the job and not fall apart doing it," he says. Tipping point "The World Cup in 2007 was a fantastic event, but the last two weeks were hard. "I was in France, but I just spent my time either going to matches and press conferences, or lying on my back on my bed. "That was the tipping point and then England went to South Africa that summer. "I came to the conclusion that I could not give the job the justification it needed or myself. "I was taking so much out of myself it was hard to live a good normal life outside of it. "One of the things with MS is the incredible fatigue. "I found I was not approaching my job as well as I wanted to, or as it deserved to be done. I was looking at things like going to a stadium not in terms of 'Great, I have a fantastic commentary to do on a match', but more, 'How difficult is it going to be physically for me to get up there?'"

So Alastair took medical retirement, bowing out the same day as former England captain Lawrence Dallaglio quit playing the game - 31 May 2008. Alastair, who played rugby for Bristol and cricket for Gloucestershire, still writes a weekly newspaper column on sport, but said that apart from that he was happy to take an armchair view.

Diagnosis shock

He now uses a mobility scooter to get around. "I can't walk very far and I can't do stairs. I could walk to the end of the street but beyond that I would struggle - I'd probably fall or trip," he says. "I'm resigned to a scooter to get me about and do everyday things, like attending physio, which is about one mile away. "I go once or twice a week at the moment but I just wouldn't be able to go without the scooter. "When I was diagnosed and told I had an incurable disease and one that was going to be progressive and debilitating it was a huge huge shock to the system.

"I have only had two experiences of people with MS; one was my cousin who had been diagnosed with it seven years before and had not actually had any other symptoms. "And on the other hand the wife of a friend of mine had died with it. "She had a galloping form of MS which had taken her from active to wheelchair, to bed, to bedridden and then she died from influenza because her system could not cope with the problem. "These were the two extremes and I was rather hoping I had the first rather than the second, but was sent scurrying to the internet to discover everything I could."

Alastair had an MRI scan, eye test and lumbar puncture before being told he had the secondary progressive form of the disease - which gets gradually worse. Before diagnosis Alastair, now 54, said his doctors had been baffled by a series of seemingly unconnected symptoms of headaches, drop foot, bladder problems, pins and needles and extreme fatigue. He said his competitive nature had both helped and hindered his disease progression.

"The competitive nature of being a sportsman had me saying 'I am going to take this on', but of course that leads to frustration," he said. "Thinking you can beat something incurable, progressive and debilitating obviously leads to a lot of anger when you can't beat it. "You have to learn to go with the flow of it, to cope with it and manage it - to learn, as we say in the Multiple Sclerosis Resource Centre, 'I have MS, but MS does not have me'."

Treatment options

Alastair has tried a variety of treatments including the drug beta interferon, hyperbaric treatment (as used by deep-sea divers to counteract the bends), reflexology and physiotherapy. "I set aside a Monday for treatments every week as a way of recharging my energy levels," he said. "I would not wish MS on anyone but I would wish the side effect - that you get exposed to people's kindness and generosity. "You are made aware of the love that there is in the world. "I feel blessed to have MS, which seems a funny thing to say about a disabling progressive and incurable disease. "But it has sent me on a journey I would never have had otherwise, and I think that it has enabled me to find out how good, loving and generous people are in general."

Source: BBC News © British Broadcasting Corporation 2009 (15/11/09)

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