Cannabis trials to start on patients
The first clinical trials of cannabis-based medicines involving patients suffering from MS, spinal cord injury and other forms of severe pain have been given the go-ahead.
They will be carried out by GW Pharmaceuticals; the company licensed by the UK Home Office to research and develop prescription cannabis-based medicines. If successful they could lead to cannabis-based drugs being made widely available.
The trials, to be conducted at a number of locations, will begin in the Pain Relief Clinic at the James Paget Hospital, Great Yarmouth, under the supervision of Dr Willy Notcutt. Dr Notcutt said: "Our aim is to test some of the claims which have been made for the medicinal qualities of cannabis in a structured clinical research programme. This is an exciting moment, and we hope very much that our findings will lead to significant improvements in the pain relief available for sufferers of MS and other debilitating conditions."
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"I have been involved in trying to get movement in this area for many years now. It has been a long haul from the wilderness but I am just thrilled that we have got there first, Now I hope that this is the thing which ignites the blue touchpaper to get these trials going all over the country. In the last two years everyone has woken up to the fact that cannabis used as a medicine is something that should not be ignored and now at last we will be able to do something about. It has been around as a medicinal drug for 5000 years but it has never been in a medicine form before. So until this point we have not been able to do any proper clinical tests as you cannot really use cannabis smoked in a joint or taken orally as the basis of a clinical trial."
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Dr Notcutt said that while some might consider the announcement controversial, those suffering from debilitating diseases would welcome the news who for years had asked for proper clinical trials. He urged anti-drug campaigners to consider the trials, which are not Government-funded, as a medical step forward and not see them as the start of a relaxation in current drug laws. "I don't think people can argue this because you can prescribe heroin as a drug - and I don't talk about heroin as a painkiller in the same breath as heroin as a recreational substance. These trials cannot in any way be linked with drug abuse, it is an entirely different thing,"
He said it was a misconception that those suffering debilitating illnesses would receive the same feeling from the drugs as recreational users or that they would take such high doses. "A lot of patients are incapacitated by the pain but they don't want to be incapacitated by taking so much that they get high."
Tests will be carried out using a device that sprays medicine under the tongue so that it is absorbed by the body rather than swallowed. Only a strictly limited number of patients will take part in the first trials. However, it is expected that some 2000 people will eventually take part in the trial programme over the next two to three years.
Dr Geoffrey Guy, announcing the launch of the licensed trials, said the numbers of people who could have their suffering relieved was mind-boggling and the trials would help to establish the dose needed to relieve pain, and the best way of delivering the drugs to patients. He said: "There is a considerable body of evidence to suggest that cannabis may have a number of medicinal uses, including the relief of pain and spasm in multiple sclerosis, and for pain relief in disorders such as spinal cord injury and neuralgia. We are now well on the way to being able to demonstrate this in a controlled clinical research environment."
Two thousand patients will take part in the trials over the next two or three years. They will spray the cannabis under the tongue from where it will be absorbed quickly into the system.
"We hope to demonstrate to the authorities the safety and efficacy of the medicine," said Dr Guy. "There are patients who will benefit from these medicines but who would not think of taking cannabis if they had to break the law."
GW has already completed preliminary trials in which a small group of subjects took different cannabis preparations to determine the safe range of dose. GW has set up a database for patients who may be suitable for participation in clinical trials.
The government has indicated that if the trials were successful it would be prepared to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine. GW hopes to market prescription medicines as early as 2003.
The Medical Research Council is also about to conduct trials on cannabis. Neurologists will use different compounds of cannabis in capsule form.