on the NHS moves a step closer
The use of cannabis-based drugs to treat multiple sclerosis and terminal cancer moved a step closer yesterday when ministers asked for an investigation by the panel which vets medicines for the NHS.
Cannabis derivatives are undergoing clinical trials to see if they relieve the symptoms of MS and alleviate the pain endured by cancer patients as well as those with spinal-cord damage. The trials will run for at least another year and if they prove successful the earliest envisaged date by which a manufacturer could obtain a licence to market the drugs would be 2004.
But yesterday the Department of Health included cannabinoids in the latest batch of drugs to be referred for assessment by the National Institute for Clinical Excellence. The move was seen as a tacit acceptance that the medicines will prove to be of value in relieving symptoms such as spasms, bladder dysfunction and pain in patients with severe nerve damage.
It comes ahead of plans by David Blunkett, the Home Secretary, to make possession of cannabis a non-arrestable offence. This more relaxed approach to cannabis will be endorsed by a report from the Commons Home Affairs Select Committee today. If approved for medicinal use, drugs derived from the cannabis plant would probably be formulated so the patient did not experience any narcotic effect.
NHS to prescribe cannabis spray
Last updated 15 November 2005. A pain relieving cannabis-based mouth spray will be available on the NHS to multiple sclerosis (MS) sufferers for the first time, it was announced today.
The spray, called Sativex, contains two chemicals found in cannabis known as tetrahydrocannabinol and cannabidiol. The Home Office has said the drug, which is yet to be licenced in the UK, can be imported for individual patient's use. A doctor would have to take responsibility for prescribing the drug and it will only be available under a licence from the Home Office. Sativex will have to be imported from Canada - where it is already licenced for use - for each individual patient.
The government has asked the Commission on Human Medicines to monitor the safety of the drug, which was refused a licence from regulators last year due to lack of clinical data.
A previous study by the Walton Centre for Neurology and Neurosurgery in Liverpool concluded that Sativex reduced pain and sleep disturbance.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it did not object to the use of the spray.
The regulatory body said in a statement: "Under current regulations the MHRA may only refuse an application to import an unlicensed medicine into the UK to meet the needs of a particular patient if there are overriding concerns about the product’s safety or quality. "Lack of proven efficacy is not a ground for refusing the import."
GW Pharmaceuticals - the company that produces the drug - has said it will continue to seek a UK licence for the pain-relieving spray. About 85,000 people in the UK have MS, which causes a range of symptoms including abnormal fatigue, lack of balance and coordination, slurred speech and pain.
Commenting on today's news, Mike O'Donovan, chief executive of the Multiple Sclerosis Society called the decision a "move in the right direction".
"We believe there is now good evidence that cannabis-derived medicine can relieve distressing symptoms like spasticity and pain in MS," he said.
"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. We very much hope it will not be long before it is licensed for NHS prescription."
NHS patients to be given cannabis
NHS patients are to be given cannabis as part of a government-funded trial. The study, which is being run by the Medical Research Council, aims to find out if the drug really can help to relieve pain.
Scientists will randomly select 400 patients from 36 hospitals across England to take part in the study. They will be given one of four pills after undergoing surgery, two of which will be a form of cannabis.
They will receive a capsule containing standardised cannabis extract or a capsule containing tetrahydrocannabinol - the active ingredient in cannabis.
The remaining patients will receive either a standard pain-relieving drug or a dummy pill.
Researchers will ask the patients about their pain and general well-being at least once every hour while they are awake, over a six hour-period. The patients will be able to request additional pain relief at any time.
The researchers will then be able to compare the experiences of patients in each of the four groups and, hopefully, determine whether the cannabis-based treatments are effective.
The £500,000 trial is being headed by scientists at Imperial College London.
"Many patients and clinicians want an answer to the question of whether cannabis is effective at relieving pain," said Dr Anita Holdcroft, who will lead the study. "We need to assess the scientific merits of some of the anecdotal evidence and we need to do this in the same way as any other experimental pain treatment.
"This is a proper study in a clinical setting where patients can be routinely monitored, using an oral capsule containing a prescribed dose."
Studies have suggested that cannabis and cannabis-based medicines can help to relieve pain. Richard Spencer, who was paralysed 23 years ago after breaking his legs, said using the drug as part of a medical trial took away his pain, relaxed spasms in his legs and allowed him to sleep.
"Without it, I don't know what I would do," he told BBC Radio 4's Today programme. "I just wish it was available 20 years ago, I would have used it. Certainly, I would have had quality in my life."
Last year, a small trial involving 34 British patients with multiple sclerosis, spinal cord injury and other conditions causing severe pain, found that using cannabis-based treatments reduced their pain and helped them to sleep more soundly.
Researchers have also found evidence to suggest it can help to reduce the side effects of chemotherapy treatment given to cancer patients. In the United States, the Food and Drug Administration has approved the oral use of dronabinol, a cannabis derivative, for people with Aids. There is evidence that cannabis may stimulate the appetites of Aids patients with wasting disease. It may also help relieve the pain of menstrual cramps and childbirth. Claims have also been made for its use in treating asthma, strokes, Parkinson's disease, Alzheimer's disease, alcoholism and insomnia.
However, opponents of the use of cannabis point to the fact that it damages the ability to concentrate and, if smoked, may increase the risks of developing lung cancer.
The British Medical Association has said that only cannabinoids - part of the cannabis plant - should be used in medicine.
Two MPs today backed calls to legalize cannabis for medicinal use, saying it would offer relief to thousands of sick and elderly people suffering from chronic pain. The Labour MPs Paul Flynn and Brian Iddon were supporting a rally today in Parliament Square by the Cannabis Education Trust to raise awareness of the problems faced by medicinal cannabis users. Mr. Flynn, who has campaigned for the legalization of the drug for medical purposes for 12 years, said he planned to reintroduce his private member's bill, first presented to parliament in 2001, to prevent the prosecution of chronically ill people. "People around the world have testified in their thousands about the benefits of taking cannabis to relieve chronic pain," he said. "But because of our hang-up in this country with recreational use of the drug, we've condemned otherwise law-abiding citizens to risk jail." He said there had been legal cases in which juries had let off people who said they were using cannabis medicinally. "We must test the waters again. The law is an ass.
Judges have called for parliament to revisit the issue." Mr. Flynn blamed the political parties' fear of being painted as weak on law and order for the failure to legalize cannabis for medicinal use. "We had a bill last year that wasn't opposed by anybody to reclassify magic mushrooms as a class A drug - the same level as heroin, which is stupid because they're not at all that dangerous." Many people with multiple sclerosis have used cannabis illegally to relieve their symptoms, including spasticity - muscle tightness and stiffness - and nerve pain. An estimated 85,000 people in Britain suffer from the disease. Mr. Iddon, chairman of the all-party parliamentary drugs misuse group, favours legalizing cannabis for medicinal and recreational use, provided that in the latter case it is sold with clear health warnings.
The MP, a former chemistry lecturer, said it was "very wrong" that chronically sick patients had to choose between living in severe pain or risk themselves or one of their relatives being sent to prison for buying cannabis or growing it for medicinal use. He said most medicinal cannabis campaigners were "normal people" and did not fit the "loony cannabis smoker" stereotype. Earlier today, campaigners delivered a petition to Downing Street calling for an end to the prosecution of medicinal cannabis users. Adam Slade, who suffers from chronic pain as a result of a congenital condition, said the current law on medicinal cannabis use put him in "an awkward position". Mr. Slade, who found standard painkillers ineffective at relieving his pain, said: "Cannabis improves my quality of life but because it's illegal it doesn't improve my quality of characterization." As well as decriminalizing such use of the drug, the campaigners want a pain-relieving cannabis mouth spray to be made available on the NHS and cannabis clinics opened to provide patients with pain relief. The mouth spray, Sativex, is already on sale in Canada to treat nerve pain but the company is facing a longer wait than expected for approval in Britain. Regulators in this country asked for additional data from the company last June. Andrew Cornwall, coordinator of the Cannabis Education Trust, said the status of medicinal cannabis was a grey area of the law that needed clearing up. "The needs of medicinal cannabis users are being neglected," Mr. Cornwall, a lawyer, said. "There's no legal medicinal cannabis yet available in this country but many would argue that it was a medical necessity to provide the drug to chronically sick people to relieve their symptoms."
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News Story 20 August 2003
NHS trial of cannabis in pain control announced
A study to be run by the MRC aims to determine whether cannabis has any effect on post-operative pain control. There is much anecdotal opinion that cannabis is useful in pain but little good clinical evidence. The trial will involve about 400 postoperative patients who will be given one of four treatments in capsule form: a standardised cannabis extract, tetrahydrocannabinol, a conventional analgesic, or placebo; all will be able to request further analgesia as required. Patients will be asked regularly about pain and general well-being over a six-hour period. More information on the trial is available at Current Controlled Trials.
BBC News report; more information at Current Controlled Trials (free registration required)