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"If
we don't change what we are doing in research, we'll be in the same place in 10
years." Art Mellor, The Accelerated Cure Project | |||||
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During
the past several years we have seen some advances in research into MS. We started
out with no treatment options for MS, and now there is glatiramer acetate (waste
of money?), mitoxantrone (chemo, with AML [Leukemia] as a known side effect),
and the three interferons (waste
of money?). Unfortunately, this success is only partial; all of the available
treatments slow but do not halt the disease, and none are available for primary-progressive
type MS. | |||||
LOUIS Rowe says he is living, walking proof that embryonic stem-cell therapy works. And there are plenty of other Victorians keen to follow his footsteps to India in the hope of a miracle. The 23-year-old paraplegic returned from New Delhi after having the treatment he believes has put him back on his feet. Mr
Rowe was left a paraplegic after severing his spinal cord in a motorbike accident
in Thailand last year, with no While many Australian and international scientists have been critical of the treatment, stem-cell experts declined to comment about the latest apparent success because there is yet to be any clinical research to prove or disprove the claims. The initial $45,000 treatment will be followed up with at least two further treatments in India over the next nine months. "I've got the feeling back. It's not complete at the moment but it is starting to get there," Mr Rowe said. "One morning I woke up over there and my foot was against the cold steel hospital bed and I was able to feel that, and that was when I realised it was working." Mr Rowe was one of five Australians being treated by Dr Shroff at her Nu-tech Mediworld in the last two months. They also include quadriplegic Perry Cross, who can breathe without a ventilator and sit unaided for the first time in 14 years. A St Kilda multiple sclerosis sufferer, a Lakes Entrance woman with motor neurone disease and a Brisbane paraplegic have also travelled to India, hoping for a cure from Dr Shroff. Since developing her technique, Dr Shroff has treated more than 500 patients with stem cells derived from a single embryo derived from an IVF patient. Mr Rowe's mother Vivienne is ecstatic about his improvement. "We all feel a lot better because there is just so much hope," Ms Rowe said. "To see him stand for the first time and take steps, was just the most amazing thing -- like he'd been born again. "I always knew he would walk. I knew there was technology out there." http://www.news.com.au/heraldsun/story/0,21985,23778831-2862,00.html | |||||
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A small number of patients in the Secondary Progressive and Chronic stages of Multiple Sclerosis (MS) have benefited from being treated with SF1019.
SF-1019 is the platform technology of Argyll Biotechnologies. It was developed from extensive research into Biological Response Modifiers (BRMs) undertaken at: Mississippi State University; St George's, University of London (formerly St George's Hospital Medical School); Ohio University; and Methodist Hospital. Listen to Alan Osmond talk about SF-1019 | |||||
| Clinical
Study of Novel Multiple Sclerosis Treatment March 2008 | |||||
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BTG plc, the life sciences company, announces that dosing has commenced in a Phase I clinical study of BGC20-0134, a potential treatment for multiple sclerosis. The randomised, double-blind, placebo-controlled study will assess the pharmacodynamic, pharmacokinetic and safety profiles of single and multiple oral doses of BGC20-0134 in healthy volunteers. Louise Makin, BTG's chief executive officer, commented: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disorder and has the advantage of being an oral product." BGC20-0134 is a novel structured lipid designed to restore the balance between pro-inflammatory and anti-inflammatory cytokines. In a pilot study of a prototype compound, patients with the relapsing-remitting form of multiple sclerosis experienced clinical benefits including decreases in both relapse rates and EDSS scores, together with improvements in pain and cognitive endpoints. http://www.btgplc.com/BTGPipeline/233/BGC200134.html | |||||
| Shortfall in Funds | |||||
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Scientists supported by the Medical Research Council (MRC) are experiencing shortfalls in funds for their research, after awards to large new projects has left the council unable to award many grants. The MRC, a distributor of government funds for research, provides money for projects given top rating, but some 36 projects will not receive funding.The MRC’s chief executive, George Radda, says it has been a difficult year for applicants, and the MRC are sorry not to have been able to fund more. | |||||
| Concern over major MS drug trial | |||||
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Leading scientists have raised serious concerns about a major government study into the effectiveness of drugs used by thousands of people with MS. The study was originally being conducted by an established team at Sheffield University. But it has been switched to Parexel - the company involved in the recent drugs test which went horribly wrong causing six men to suffer multiple organ failure. The same company has commercial links to three of the four pharmaceutical companies involved in the study. There are also concerns about how much of the research will be made public. It
is feared patients currently taking expensive drugs like beta interferon
may be kept in the dark even after the ten year study is complete. The National
Institute for Health and Clinical Excellence decided in 2001 not to sanction beta
The original contract to evaluate the progress of the thousands of MS patients on the scheme was given to the Sheffield team. However, the contract was re-tendered last year following a dispute over the university's right to publish independently on their findings. Sir Iain Chalmers, editor of the James Lind Library, which reviews scientific research, is uneasy about the decision. He said: "I think it's a totally unreasonable expectation, that information which may be important to patients and prescribers should potentially be suppressed because a company does not find it in its interests to see it made public. One of the pharmaceutical companies involved in the scheme has denied that any of the research will be suppressed, even though each company in the risk sharing scheme has the right to decide if any research involving their own drugs should be published.
The scheme was being overseen by a project management group that included the MS Trust charity, four pharmaceutical companies, the Department of Health and several others including scientists and academics, but the group as a whole was not consulted about the decision to appoint Parexel, which was taken instead by the drugs companies, the Department of Health and the MS Trust. | |||||
| Metals
link to multiple sclerosis (February 2006) | |||||
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Multiple sclerosis could be linked to difficulty in processing iron and aluminium, a study has suggested. Scientists at Keele University, Staffordshire, compared levels of the metals in the urine of people with MS and others without the condition. Significantly higher levels than expected were found in both groups. The study compared 10 MS patients with the relapsing-remitting form of the disorder and 10 who had the more advanced secondary progressive form with 20 people who did not have MS. They looked at iron levels because the metal has been linked with the facilitation and acceleration of oxygenated damage. It was found that iron levels were significantly higher in people with MS, particularly so in those with the secondary progressive form. People with the relapsing-remitting form of MS were found to have very high levels of aluminium - up to 40 times those seen in the group who did not have MS. The levels are as high as those seen in people with a condition known as aluminium intolerance. Dr Christopher Exley, a bio-organic chemist at Keele, who ran the study, said: "We know from animal studies that myelin is the preferred target for aluminium. "As myelin breaks down, something called myelin basic protein is found in urine. "It could be that aluminium is coming out with that. We are going to do further tests to see if that is the case." The present understanding is that developing MS is due to a combination of having a genetic susceptibility and environmental factors. Dr Exley said: "We hypothesise that susceptibility genes may have something to do with how iron is metabolised in the body - something may be going wrong. "And it may be that aluminium is a previously unrecognised factor that exacerbates that problem, which then manifests itself in some as MS." | |||||
| Aimspro | |||||
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Patients with MS have experienced dramatic improvements in their condition after taking part in trials of a drug derived from goat serum. Some have reported being able to cast aside their walking sticks and walk for miles, or of regaining their vision or finding they can again use their limbs after years when any movement was agony. The treatment, given as a weekly injection, is derived from purified serum from immunised goats that produce antibodies. Of the 130 patients on the trial, 85% reported big improvements with no side effects. Dr David Maizels, a family doctor from Chiselhurst in Kent, who had been treating patients in the “informed consent” trials for the past three years, said he had never seen anything like it. “I want to emphasise that this is not a placebo effect. The improvements are sustained and there are almost no side effects. At times the results are amazing,” he said. Among them is Billy Edmiston, of Southsea, who says “I am 500% better than I was. I can walk for several miles without sticks. I’m much stronger and generally healthier.” The success of the trials has started to gain international recognition, with Alan Osmond travelling from the US to take the drug. | |||||
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Decision on Terminated Clinical Trial The Board of Daval International Limited decided, in 2004, to terminate the first full-scale clinical trial of AIMSPRO at St George's Hospital, London. A complaint against the responsible hospital pharmacist was then lodged by Daval with the Royal Pharmaceutical Society of Great Britain. The allegations of misconduct against the pharmacist were considered by the Investigating Committee on 4th March 2008 and it's judgement fully vindicates Daval's action in discontinuing this study. The Committee reasoned that there were a number of factors and areas of responsibility which contributed to the failure of the clinical trial and that the pharmacist had failed to take control of his responsibilities by ensuring that appropriate standard operating procedures were in place. As regards future human studies, Daval's interests are somewhat protected by the tighter Clinical Trial regulations in the United States, Europe and Australia that are now in force. It is re-stated that the company's over-riding priority, as it passes through the development phase of AIMSPRO, a complex biological medication, will be that of patient safety. Link to Daval International: http://www.davalinternational.com/ | |||||
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More Children Diagnosed With Multiple Sclerosis
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Makers of Tysabri Withdraw MS Drug From Market and Trials LINKED TO RARE, OFTEN FATAL BRAIN INFECTION Tysabri,
the multiple sclerosis drug released to the public with great expectations in
November The drug's manufacturers, Biogen Idec Inc. and Elan Corp, plc voluntarily withdrew Tysabri from the market and halted any further clinical trials after the second fatality linked to the drug was reported. They are currently working with the FDA to determine the exact nature of the link between their drug and the disease, and if there is a way to use the drug without risk of the dangerous side-effect. Update: An extensive review of safety and effectiveness was completed by an advisory committee to the FDA in March 2006. It confirmed that there were no additional cases of PML and the FDA resumed prescribing of Tysabri. The FDA have installed a risk-minimisation programme including mandatory participant registration and regular follow-up to minimise the risks of developing PML.. Link
to a questions and answers page on Tysabri: | |||||
| MBP8298 | |||||
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BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis, announces that the first patients have been enrolled in its pivotal Phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis, which affects approximately 40% of MS patients worldwide. The trial is expected to enroll up to 553 patients and will be a double-blind, placebo-controlled study involving multiple trial sites. Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. "This trial has been designed to confirm the efficacy and safety shown by MBP8298 in previous clinical trials, particularly in patients with specific genetic profiles often associated with MS. We also anticipate gathering additional data regarding the potential of this treatment in patients with other types of MS," said Dr. Leopold Arfors, Medical Director. Further information regarding the enrollment of patients can be found at the company's website at http://www.biomsmedical.com | |||||
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| MS Drugs 'a Waste of Money' | |||||
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Scientists are questioning the effectiveness of multiple sclerosis drugs Beta Interferon and Glatiramer Acetate. Interferons have been used widely for the treatment of MS for almost a decade, and are available, along with glatiramer acetate, for this use free of charge from many national health services. However, the long-term effectiveness of both drugs has not been confirmed and any beneficial effects might be outweighed by their side effects and high costs. In an analysis of trials conducted so far on the use of interferon in patients with the relapsing-remitting form of MS, interferon had a “modest” protective effect during the first year of treatment. However, results could not be determined for the second year due to |
trial weaknesses, including high dropout rates and little to no follow-up of patients, and differences in reporting of methods. Side effects were greater among patients taking interferon than those taking a placebo. Flu-like symptoms were common and the occurrence of leucopenia, raised liver enzymes in blood, lymphocytopenia, and thrombocytopenia was higher than controls. Scientists conclude that while interferon may have a modest effect during the first year of treatment, its effectiveness beyond one year is not known. Despite this, patients are commonly treated with interferon for long time periods. Scientists say that the drug’s effectiveness should be assessed. | ||||
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Scottish Doctors Prescribe Cannabis On The NHS Feb 2008 Scottish doctors have started prescribing cannabis on the NHS before it is officially licensed in a bid to relieve the pain of multiple sclerosis sufferers. Medics, apparently frustrated by years of trials of medicinal cannabis, have decided to wait no longer and are legally obtaining the drug Sativex direct from the manufacturer. GW Pharmaceuticals announced in 2005 that it had been informed by the Home Office that the Drugs Minister, Paul Goggins, had confirmed that Sativex(R) oromucosal spray may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This means that the prescribing of Sativex can only be permitted under Home Office licence. The Home Office has developed a licensing regime to fit these circumstances. Doctors are allowed to prescribe unlicensed drugs in the UK if they think it is in the best interest of their patient, but they are liable for any unforeseen consequences. Sativex contains two purified forms of cannabis and is considered highly effective at controlling the pain and spasms associated with MS. It contains an extra ingredient which prevents the patient getting a 'high'. Many cancer and MS sufferers resort to cannabis in its illegal form as pain relief and several have been prosecuted, including the late Biz Ivol, from Orkney, who made cannabis chocolates and posted them to fellow sufferers. Trials of Sativex have been ongoing for at least four years and it will be later this year before the makers submit an application for UK licensing. But prescription figures from the Information and Statistics Division of the Scottish Government's health department indicate that around a dozen patients are already being supplied with the drug by their doctors. The true number of Scots receiving the drug is probably higher because those figures do not include prescriptions requested by hospital consultants.
One patient who has benefited from the drug is MS sufferer Joyce Fisher, from Dollar, Clackmannanshire. The 45-year-old former library assistant has had the condition for 15 years and is now confined to a wheelchair. Her GP agreed to prescribe Sativex after Fisher heard about the drug last year, and she took it for three months. However, she says her local health board, NHS Forth Valley, will no longer fund her treatment. "Sativex eased the pain within the first two days and it also relieved the muscle spasms. It relaxed my body and allowed me to stand up and exercise." Patients have long campaigned for the legalisation of cannabis for medicinal purposes. Scotland's best-known campaigner was MS sufferer Biz Ivol, from Orkney, who died in 2004 after falling ill with a chest infection and refusing any further medication. Ivol was admonished at Kirkwall Sheriff Court in 1997 after she admitted growing 27 cannabis plants to relieve her pain. She produced cannabis chocolate bars, "cannachoc", for fellow sufferers. Last night Linda Hendry, spokeswoman for the Legalise Cannabis Campaign Scotland and a former acquaintance of Ivol, said Sativex could have saved Ivol's life. Motion put forward in the Scottish Parliament, 18th June 2003: That
the Parliament sends its support and solidarity to Orkney woman Biz Ivol, who
has highlighted the situation of people with multiple sclerosis (MS) who need
to seek medical supplies of cannabis to help alleviate their suffering; is seriously
concerned about the health of all MS sufferers when the range of effective medical
help that they have at their disposal does not include medical cannabis supplies;
calls for greater financial resources to be allocated to help search for treatments
that alleviate the symptoms of MS; believes that these treatments include the
medical use of cannabis and further calls on Her Majesty’s Government to issue
an immediate review of the law regarding the use of cannabis for medical purposes
so that MS suffers like Biz Ivol are not treated like criminals. Orkney and Shetland MP Alistair Carmichael is calling for the law to be changed. He said: "It's ridiculous people looking for relief from pain from an incurable disease such as multiple sclerosis are left in a position where they are made criminals." In
California we passed Proposition 215 which allows physicians to recommend the
use of marijuana for medical purposes. They may not, however, prescribe it, so
it's not as easy as going to the pharmacy just yet unfortunately. There are many
medical marijuana co-ops all over the state. A patient goes to one, shows his/her
medical marijuana ID card, and makes a purchase of medication. Governor Gray Davis
signed SB 420 into law before leaving office. This gives patients better rights
to their medicine, including a new state run medical marijuana ID card system
that is voluntary. Currently, the clubs take ID cards from the Oakland Cannabis
Buyer's Cooperative, which is currently the official verifier of patients' recommendations
from their doctor. Politics outsmarts Science at the FDA For a Food and Drug Administration (FDA) increasingly mired in controversies over the politicization of scientific and regulatory decisions, the agency's April 20, 2006 statement regarding medical use of marijuana may represent an all-time low point. Politics, it appears, has now completely trumped science at this once proudly independent agency. The FDA has announced that "no sound scientific studies" support the medical use of marijuana, contradicting an increasingly large body of scientific literature. To those of us who do research in this area, this is a personal affront. Even the federal Drug Enforcement Agency's (DEA) own Administrative Law Judge, the Honorable Francis Young, stated in 1988, "Marijuana is the safest therapeutically active substance known to man..." He went on to say, "The evidence clearly shows that marijuana is capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. . .it would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance." Perhaps more remarkable were the conclusions of President Nixon's Shafer Commission, who were appointed to investigate marijuana's available scientific and medical evidence. To the shock and dismay of President Nixon, the Commission found enough evidence to recommend that marijuana be decriminalized. Click here to read the rest of this article From July 2001: Canada is to become the first country to legalise possession of cannabis to chronically ill people - if it will help them cope with their conditions. From the end of this month, patients will be given photo identity cards stating they have a right to possess or grow the drug. This compassionate measure will improve the quality of life of sick Canadians, particularly those who are terminally ill. Patients have reported that cannabis helps to relieve the symptoms of a variety of diseases, including arthritis, cancer, Aids and multiple sclerosis. The Canadian health minister, Allan Rock, described the new regulations as a compassionate measure. But Hugh Scully, a former president of the Canadian medical association, criticised the move, saying that too little was known about possible harm from the drug. In Britain, juries have acquitted defendants who say they have smoked the drug for medical purposes, even though the law does not allow it. The United States Supreme Court, on the other hand, recently ruled against moves in California to relax the law. Canada is now giving some patients the formal right to possess cannabis and to grow a limited number of plants. They will be able to apply if their doctors certify that they have a terminal illness or one of a number of specified medical conditions - and that conventional treatments have not worked. The Canadian Government also plans to license a company in Saskatchewan to start growing cannabis legally. However, for the time being, there will be no legal way for sufferers to obtain the drug other than to grow it themselves, or to have it grown by a nominated friend or relative. Commercial production will continue to be a criminal offence. Officially, the new rules have no implications for the law in Canada on recreational use of cannabis. But there, as in many countries, the pros and cons of de-criminalisation are being hotly debated. | |||||