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UK: Cannabis drug available to MS patients
Nigel Hawkes The Times
Wednesday 16 Nov 2005 PATIENTS with multiple sclerosis can be treated with a cannabis-based medicine, despite its failure to win a licence in Britain. The Home Office opened the door yesterday to the importation of Sativex from Canada, where it is licensed. This will enable doctors to prescribe it to specific patients, but the doctor, and not the drug company, is liable if anything goes wrong. The decision by Paul Goggins, a Home Office minister, was made in spite of the refusal of regulators last year to award Sativex a full licence in Britain until more clinical data was provided. GW Pharmaceuticals, which makes the drug, said that there was scope within the Medicines Act for a drug to be supplied in response to a specific request from a GP even if it has not yet been licensed. "The basis on which Sativex may be imported, therefore, is the clinical judgment of doctors in relation to specific, nominated patients," the company said. Because the drug is based on cannabis, a controlled substance, the Home Office had to agree to its importation. Once in Britain, doctors can prescribe it - as they can any substance that they believe will do their patients good - at their own discretion. Sativex comes in the form of an oral spray designed for the relief of pain and of involuntary muscle contractions in MS sufferers. Because it will remain a controlled drug, GW said that talks will take place with the Home Office during the coming weeks over how a licensing regime can be put in place. GW confirmed that it still intended to seek full regulatory approval for Sativex in Britain. It is conducting further trials and plans to submit a fresh application for a licence next year. A Department of Health spokeswoman said: "It is vital that we ensure that drugs are safe before they are used in the NHS. Last year the MHRA refused a licence for Sativex . . . but a clinician may prescribe the drug for unlicensed use for named patients in exceptional cases." Mike O'Donovan, chief executive of the Multiple Sclerosis Society, said: "This is a move in the right direction. We believe there is now good evidence that cannabis-derived medicine can relieve distressing symptoms in MS. "Many people do not find available treatments effective and will now have the opportunity to try a new drug, which could significantly improve their quality of life." - A study published this week in Rheumatology found that Sativex was effective in treating rheumatoid arthritis. The trial was small, involving 56 patients, and the results were variable. But the researchers found that patients who had taken Sativex felt less pain, slept better and had less inflammation than those given a placebo.
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