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

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 interferon - or another MS drug, glatiramer acetate - for use on the NHS, ruling they did not represent value for money. However, after a sustained campaign by the pharmaceutical companies, charities and patients, the government came up with an alternative approach known as the Risk Sharing Scheme. Under its terms, the government committed around £500 million to providing the MS drugs over a ten year period while scientists studied their long-term effectiveness. If the study reveals the drugs are not as effective as the pharmaceutical companies say, they will have to drop the price of their products to the NHS.

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 move to a commercial company has also dismayed one of the world's experts on Multiple Sclerosis whose research data was being used by the scientists at Sheffield University. George Ebers, professor of clinical neurology at Oxford University, said: "I think you'd have to have a pretty good reason to change horses in the middle of what is a pretty rocky and rapid stream. "One has a certain bit of worry here that you've got an academic group with a well-established and well earned reputation in this whole business and in particular MS, and then for reasons which I don't understand they're replaced by a clinical research organisation. "I have reservations about this being a clinical research organisation that's going to be involved in determining efficacy."

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.

Update - 17/03/08

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/

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 2004, continues to raise concerns after its withdrawal from the market due to its possible involvement in cases of a rare and often fatal brain infection. A fifth case of the brain disease with possible ties to the drug has been reported to federal authorities. Three cases of the disease, known as progressive multifocal leukoencephalopathy or PML, have been confirmed in patients on a long-term course of Tysabri. The patients were continuing on the drug after participation in clinical trials of the drug prior to its release to the public. Of these three, two have died. Two additional cases of PML in MS patients taking Tysabri, including this most recent one, have not yet been officially confirmed.

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:
http://www.fda.gov/cder/drug/infopage/natalizumab/natalizumabQA_2_2005.htm

FACT: Cannabis eases pain and muscle spasms for people with Multiple Sclerosis, and has been shown in trials to slow down the progression of MS and even aid in the repair of damaged Myelin.

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.

Sativex has already been approved as a prescription medicine in Canada. A spokesman for GW Pharmaceuticals said: "We are working very hard to finish clinical trials, which are necessary to get a full licence. The good news for patients is that the mechanism does exist that allows them to have access to this medicine. The final decision on whether to prescribe it to a patient is a matter for individual health boards."

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.
(S2M-157 Colin Fox)
Supported by: Chris Ballance

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."

From Nathaniel in California:

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.

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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.