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UK Medical Cannabis Trials

There has been an amazingly rapid change in government policy in the UK, regarding medical cannabis. A go-ahead has been given to full clinical trials of the medical effects of cannabis. 2000 patients will take part in the properly controlled, properly scientific trials, which remarkably will use inhaled (not oral!) whole plant extracts (not synthetic derivatives!) of cannabis. Further details of the trials are being released all the time and page gathers them all together

Cannabis Inhalers in First Legal Health Test

Daily Telegraph (UK)
13 June 1999

Patients in Britain's first clinical trial of cannabis will take the drug through an inhaler similar to those used by asthma sufferers.

The device, to be unveiled this month, will use vapours from heated cannabis aimed at giving quick pain relief to hundreds of multiple sclerosis, neuralgia and glaucoma sufferers taking part in the trial. The cannabis, a brown viscous liquid, will be heated in a laboratory oven and placed in the inhaler, the size of a mobile phone. The patient will inhale the vapours through a tube under medical supervision. Pain relief is expected in minutes. Eventually, it is planned the heating mechanism will be incorporated into the inhaler.

The drug, which produces an analgesic effect in small quantities and a "high" in larger amounts, is only activated when heated. It is hoped that the trial, involving 900 patients over a three-year period, will begin in July, subject to approval by the Medicines Control Agency. One hundred patients are being selected for the early stages.

Most patients will be MS sufferers but there will also be people with neuralgia, glaucoma and post-operative pain. The dosage will be large enough to relieve pain but not enough to make them "high". If the drug is shown to ease symptoms without side-effects, doctors could be prescribing it to some of the country's 85,000 MS sufferers within five years.

Inhaler technology has existed for some years but GW Pharmaceuticals - which is conducting the trial - has been working with the manufacturers for a year to adapt it for cannabis use. Mark Rogerson, a spokesman for GW Pharmaceuticals, said: "The most important thing is being able to replicate the beneficial effects of inhaling cannabis without the harmful effects of smoking and that's why so much effort has gone into making this inhaler."


Sowing seeds for cannabis cure-all

The Times, (UK)
23 Jan 1999

SIX months ago David Watson might have been dismissed as an oddball whose obsession with cannabis came from spending too much time in California and the Far East. But as he tends the hundreds of sweet-smelling specimens in his secret Amsterdam greenhouse, he rejoices that his dreams of cannabis as a panacea of the 21st century could become reality.

For Mr Watson, a 49-year-old American businessman and self-taught horticulturalist, is the mastermind behind Britain's first licensed cannabis crop to be farmed for medical research. As it was being harvested earlier this week, he described for the first time his involvement in a project that is publicly fronted by a British scientist, Geoffrey Guy.

At his one-acre greenhouse on the outskirts of Amsterdam, Mr Watson explained how he has spent the past six years breeding hundreds of varieties of cannabis in the hope that one day its compounds will be used to treat conditions such as multiple sclerosis, the side-effects of chemotherapy, insomnia and anorexia.

His expertise was such that, when Dr Guy was given his Home Office licence, he contacted the American for help. "Dr Guy asked us to supply seeds and teach them how to grow the crop. I also found his greenhouse for him in England," he said. "I am not allowed to tell you where it is, only that it is one of the most secure, sophisticated sites there is. It has the technology to grow the crop in very precise conditions and, to keep out intruders, it is covered with razor wire, cameras and movement sensors."

Dr Guy's drugs company, GW Pharmaceuticals, has invested millions of pounds in the project and if trials with 900 sufferers of multiple sclerosis and post-operative pain are successful and the results accepted by the World Health Organisation, it would pave the way for legislation to enable doctors to prescribe it. Mr Watson, who has a staff of five, says: "The market could be worth a billion dollars a year and Dr Guy would make a lot of money.

The UK has in effect taken the leadership away from The Netherlands in this field. By doing clinical trials Dr Guy will be able to sew up all the patentable ideas and concepts. "We are not about to be millionaires, though - we just have the contract to supply the seeds and the know-how."

Showing me around his tiny laboratory, where an assistant is busy chopping up cannabis leaves for analysis, he admits he is obsessed with his work, spending most of his waking hours co-ordinating the research and writing reports. "My wife and kids would prefer it if I was less driven but I wouldn't want to do anything else. I know this is good medicine."

He recounts how a friend who underwent a liver transplant was able to throw away her pain killers, muscle relaxants, tranquillisers and sleeping pills after he advised her to smoke cannabis. "She was in a very bad way but after two weeks she was able to stop all her medication, including cannabis."

Mr Watson, a former clothing manufacturer, discovered that a cannabis compound was being synthetically produced in the US for $8 a pill for limited prescription. The realisation that the drug could be produced naturally for very little cost and that there was extensive anecdotal and scientific evidence of its wider therapeutic properties prompted his move to Amsterdam in the late 1980s where he was given a research licence from the Dutch Government after setting up his company, Horta Pharm.

His enthusiasm is obvious when he pulls open a large plastic bag of cannabis resin in the laboratory and thrusts his fingers into the pale brown powder. "It's so soft, just like talcum powder! Here, have a feel," he coos. My hand smells like the inside of an Amsterdam coffee shop for the rest of the day.

In the greenhouse he points out the broad-leaved Afghan variety and the thin-leaved Thai specimen. "Look at the leaves on this one, aren't they beautiful?" he enthuses, as he gently strokes the luminous green fronds of a six-foot monster. Pointing out the tiny resin heads among the flowers of one plant, he explains that these contain the active ingredients such as THC, CBD and CBG, which are believed to be the most beneficial to patients.

In the laboratory they are extracted by crushing the plant and adding chemicals such as ethyl alcohol. The ratios of compounds can then be measured in a gas chromatograph machine which gives a computer read-out.

THC is the intoxicating compound that gives recreational users a "high", which has made governments wary of legalising the drug, he says. "It may one day be possible to produce cannabis with all the right medical compounds but with no psychoactive effects. This would make it much more acceptable to the legislators."

After traveling the world to collect hundreds of varieties, Mr Watson claims to have the biggest living cannabis library. Under the expert supervision of his chief plant breeder, Etienne de Meijer, the plants are cloned, inbred or crossed to produce different ratios of the active compounds, and the seeds sent to the British farm for cultivation. During clinical trials Dr Guy will aim to find out which variety work best for which condition.

Mr Watson's team has also developed a vaporiser that bypasses the need to smoke or eat cannabis. It works by delivering heat to the resin. Although he lives in a city where recreational cannabis use is tolerated, Mr Watson is coy about discussing the subject. "That is not an issue we are willing to talk about because it has nothing to do with our work here," he says.

Has he used the drug himself for a medical condition then? "No. I am diabetic but unfortunately cannabis cannot help."

Is he worried that his two daughters, aged 16 and 21, might be tempted? "The eldest might have tried it but I know my children aren't interested."

Retrieving an ancient medicine bottle labelled "cannabis" from a cupboard in his office, Mr Watson insists: "Look, it was once the most widely prescribed medicine in the world before it was banned by most governments earlier this century because of its intoxicating effects. Here in Amsterdam there is a lot of compassion for those who want to use it recreationally so it is tolerated in coffee shops but for those who want to use it for medical use, there is nothing. "Doctors can't legally prescribe it here or in Britain. The patients have to rely on poor quality cannabis from coffee shops or dealers. Where is the compassion in that?"


Hunt for cannabis cure

Daily Mail (UK)
19 Jan 1999

THIS year will see two separate research initiatives which aim to establish if cannabis does have medicinal properties.

One carried out by a private company, GW Pharmaceuticals, will involve an aerosol mixture of pure cannabis.

The second, organised by the Royal Pharmaceutical Society, will examine whether the active ingredients in cannabis can be extracted and formulated into a new medication.

If the research results are accepted as valid by the World Health Organisation, then other pain sufferers will be able to use cannabis on an individual 'named patient' basis until the law can be changed.

GW Pharmaceuticals spokesman, Mark Rogerson explains: "We are producing an extract from the whole plants, which is a bit like syrup. It will be delivered to the patient in the form of a heated vapour because cannabis needs heat to work.

"Patients will use a very clever device rather similar to the nebulisers used by people with asthma." I about six months time, two trials will be carried out, overseen by the Royal Pharmaceutical Society. One, involving 300 volunteers, will establish whether cannabis can relieve post-operative pain (pain following surgery).

The other, with 600 volunteers, will check if the drug can relieve muscle spasms in people with multiple sclerosis.

It has been estimated that 1000 people with MS already use cannabis illegally to relieve muscle spasm.


These women could be the first to take cannabis legally - but should they be allowed?

by Ann Kent, Daily Mail (UK)
19 Jan 1999

These women are pillars of the community, the kind of people who always turn up at school parents' evenings. Yet they also habitually break the law - by smoking cannabis as a painkiller.

Now they could be among the first Britons to be administered the drug legally. As part of a unique and controversial new study, they will inhale cannabis to try to establish if it really does have medicinal effects. They already take the illegal drug to alleviate excruciating pain and muscle spasms, buying it from street dealers. At least now they will be able to obtain it in a safe, standardised form.

DIANA BEEDLE, 44, from Torquay has been disabled with chronic back pain for 13 years. She says: "I tripped on the stairs when I was rushing to answer the door and fell all the way down. It caused sever damage to discs, vertebrae and nerves. I was on my back in hospital for three months, and was left with severe pain and a leg that went into spasms.

"I stuck to prescription drugs for nearly three years and also tried TENS machine and chiropractic. But nothing worked as well as cannabis - something I tried, reluctantly, after a friend suggested it and bought some for me.

I smoked it first thing in the morning. If I didn't, my muscles would go into spasms and I would barely be able to move. I also smoke in the evening to help me sleep. I see myself as a totally law-abiding citizen and would hate anyone to think of me as a criminal. You see MPs interviewed with a scotch in one hand and a cigarette in the other. They're taking much more dangerous drugs than I am. There has never been a death attributed to cannabis alone."

SYBIL LUCAS-BREWER, 43, of Preston was diagnosed with severe rheumatoid arthritis ten years ago, and is registered as disabled. She says: "I don't feel comfortable about taking an illegal drug, and using it is the most illegal thing I have ever done. Unfortunately, with painkillers you get immune to the effects.

"When my arthritis flares up, the pain is soul-destroying - life-sapping. If you take too many painkillers, you just sit in a chair and dribble. You want to go to sleep and not wake up.

"I try to relieve my pain by meditating, and use cannabis as a last resort. It was something a friend told me about.

"If I am chosen for the trials there is a chance I will get a placebo, which will do nothing for my pain. But it is worth the risk. I want the authorities to realise how effective cannabis is, because even when I get hold of it, I can't really afford it on my disability benefit.

"it is expensive because it is illegal. Cannabis would be cheap to manufacture if legalised. If it could be made available as an aerosol medicine, that would be ideal. It would hit the bloodstream instantly and give maximum pain relief.

"An awful lot of people take cannabis, but you don't hear about them. When I was in hospital a while ago, an old lady on the ward, who also had arthritis, took me into the grounds and rolled me a joint. She was in her 70's and she was perfectly matter-of-fact about it."

CLARE HODGES, 41, a house-wife and mother from Leeds, has multiple sclerosis. Seven years ago she set up the Alliance for Cannabis Therapeutics (ACT) to campaign to have cannabis made available on prescription. She says: "I am a nice, middle-class mother of two, and I belong to our local Crimebusters Group. Until recently, the supporters of Act have been lone voices. Now e have support in the House of Lords. I had Ms for nine years before I tried cannabis. I found it stops muscle spasms and helps against nausea. It also relieves bladder problems, so I don't have to constantly get up in the night to go to the loo.

"I hope something is sorted out because thousands of people with medical problems use cannabis in a potentially dangerous way. You don't know the quality or the strength of what you are taking, and forced to break the law.

"I don't feel as if I am a threat to society. Nor are we a crowd of dope-smokers - most people don't take enough to get high. We take cannabis because we need to."

VOLUNTEERS for research should contact Disability Now, 6 Market Road, London, N7 9PW


Doctors volunteer to test cannabis

The Daily Telegraph (UK)
12 Jan 1999

THE therapeutic effects of cannabis are to be tested by two doctors who have volunteered to run the first official patient trials.

Dr Anita Holdcroft, from Hammersmith Hospital, London, will investigate whether the drug or some of its components can relieve post-operative pain. A second trial investigating the effects of cannabis on multiple sclerosis sufferers will be run by Dr John Zajicek, of Derriford Hospital, Plymouth.

Three hundred patients will take part in the post-operative pain trial and 600 in the MS trial. The doctors signed up for the trials yesterday at a meeting of Government officials and scientists at the Royal Pharmaceutical Society in London. Delegates were there to set guidelines for the trials.

Cannabis contains chemicals which are said to be useful as painkillers and for treating illness such as MS and epilepsy. Many MS sufferers now take the drug illegally. Dr Zajicek's trial will look specifically at the ability of cannabis to control spasticity - muscle rigidity - in MS patients.

The Home Office has already granted special licences to a drug company, GW Pharmaceuticals, allowing it to grow and supply cannabis for medical research. An initial crop of 5,000 plants was sown in August at a secure glasshouse in the south of England. The mature, 8ft plants are now being cut off just above the stem and hung up to dry before being transferred to a laboratory.

The aim of the trials is to obtain results that will be accepted by the World Health Organisation. Findings from previous studies have not been recognised as scientifically sound. Acceptance by WHO would pave the way for cannabis to be rescheduled under the Misuse of Drugs Act. Standardised preparations of cannabis or its active ingredients could then be prescribed, subject to certain regulations.

Prof Tony Moffat, chief scientist at the Royal Pharmaceutical Society, said that the tests should offer "conclusive scientific evidence" that cannabis could have therapeutic benefit. The trials are likely to start in six months' time. Assuming that they showed cannabis to work as a medicine, it could be prescribed on a named patient-only basis before being licensed.

It would take at least five years for cannabis or its active components to be fully licensed so that it was widely available on the NHS. One question that must be settled first is how the drug might be administered to the patient.

Dr Geoffrey Guy, chairman of GW Pharmaceuticals, has developed a special inhaler device for taking measured amounts of cannabis. Whether this system or another - such as capsules or injections - will be employed remains to be decided.


Secret farm harvests legal cannabis for medical trials

The Guardian (UK)
5 Jan 1999

Five thousand cannabis plants are being harvested at a secret drug farm for therapeutic research - with the approval of the Home Office.

The crop was sown in August at a glasshouse in the south of England. The 8ft tall plants are being cut off just above the stem and hung up to dry before being transferred to a laboratory.

The Home Office issued special licences for the cannabis farm to be set up, in the light of evidence that the drug has therapeutic value and could be especially useful as a pain killer and in treating illnesses such as multiple sclerosis and epilepsy. Eventually 20,000 plants will be under cultivation at the secret location.

Trials on whether cannabis can help multiple sclerosis sufferers begin this spring. Up to 2,000 patients are expected to take part.

Geoffrey Guy, chairman of GW Pharmaceuticals, which is growing the crop under high security, said: "We will be using whole plant extracts for delivery by inhalation, since this is far more precise and controllable than the oral route.

"The first area of study in patients will concern the relief of nerve damage pain, including for sufferers of MS."

The company is growing a potent variety yielding large amounts of chemicals that induce a "high". Because of its potential illegal street value, the crop was guarded round the clock as it reached maturity.

GW Pharmaceuticals has two licences, one allowing it to cultivate cannabis and the other allowing the possession and supply of the drug for medical research.

It is collaborating with the Dutch company HortaPharm BV, specialists in breeding medicinal cannabis.


Ministers Approve NHS Cannabis Tests

Sunday Telegraph (UK), 27 Dec 1998

THE Government is officially to sanction a series of trials, involving more than 1,000 patients, into the therapeutic uses of cannabis, The Telegraph has learnt.

The Medical Research Council and the Royal Pharmaceutical Society will set out the guidelines for the trials on January 11 at a closed scientific meeting to be attended by Department of Health officials.

The Medicines Control Agency, the Government's licensing authority for prescription and over-the-counter drugs, has agreed to advise the scientists on the regulatory aspects of the proposed trials.

The Prince of Wales last week appeared to lend his support to the campaign to legalise cannabis for therapeutic uses when he asked a multiple sclerosis sufferer if she had ever tried the drug for pain relief.

The patient was later quoted as saying: "He asked me if I had tried taking cannabis, saying he understood that, under strict medical supervision, it was one of the best things for it."

But Peter Cardy, chief executive of the Multiple Sclerosis Society, said that he was inclined to think it was for a doctor - rather than Prince Charles - to make recommendations about trying cannabis.

The drug trials will mark the first time that the Government and its agencies have given official sanction to investigating the therapeutic value of cannabis and its derivatives, cannabinoids.

The move follows a report from a House of Lords scientific committee which said that doctors should be allowed to prescribe cannabis for multiple sclerosis sufferers and other patients who find it helps to relieve pain. Each of the initial three trials will cost about UKP 500,000, with funding from the MRC if it gives final approval.

The first trial will be for spasticity in multiple sclerosis patients. One group of about 100 patients will be given the ordinary treatment for controlling muscle spasms.

The second, similar-sized group will receive tetrahydrocannabinol (THC), a cannabis derivative known to have an anti-sickness effect, as well as producing euphoria.

A third group will be given standardised cannabis plant material in order to see if THC is the most important compound or if there are other elements of the drug which help patients.

The following two trials will be into the treatment of chronic pain for dying cancer patients or those with phantom limb problems, and for acute pain following operations.

Professor Tony Moffatt, scientific adviser to the Royal Pharmaceutical Society, said that the test on acute pain would be one of the easiest because it would take only one dose of the cannabis, or its derivative, to see if the amount of morphine could be reduced.

Prof Moffatt said that the trials were "all about getting cannabis into patients who need it". He said: "Despite all the huffing and puffing over whether it should be legalised, nobody has done anything about it. There is no good scientific evidence that these materials are effective at all."

THC is not legally available to patients in Britain, as it is in America. The Home Office and the MRC have, however, agreed to provide exemption certificates allowing its use in clinical trials.

The British Medical Association maintains its opposition to any change in the law until there is scientific proof of its therapeutic efficacy.

However, Clare Hodges, of the Alliance for Cannabis Therapeutics, said that she was delighted that the trials were to go ahead after years of pressure from patients.

The tests are expected to start in the summer and to run for 18 months.


Multiple Sclerosis victims to test medical effectiveness of Cannabis

The Guardian (UK)
Tue, 28 Jul 1998

Sarah Boseley


LONDON -- The first human trials of the medicinal properties of marijuana will controversially involve inhaling substances made from the entire weed, not derivatives, it became clear Tuesday.

Dr. Geoffrey Guy, chairman of GW Pharmaceuticals, a company he set up with a license from the British Home Office to explore the medical uses of marijuana, told the House of Lords select committee on science and technology in London that he expected to move to clinical trials, probably with multiple sclerosis sufferers, within the next few years. He hoped the drug would be licensed as a medicine within five.

It became clear during his evidence that he believes it will be difficult to discover exactly what combination of cannabinoids -- molecules derived from the plant -- has the pain-relieving, muscle-relaxing effect that sufferers from MS and other diseases claim they experience when smoking the illegal drug.

Asked about synthesizing the chemicals found in the plant in order to produce a safe medicine, he said, "I don't see the value in taking apart something that seems at the moment to work."

The British Medical Association, which gave respectability to calls for the medicinal properties of the drug to be explored, backed the legalization of cannabinoids -- not cannabis itself -- to treat MS and other conditions.

But there has been a growing lobby in Britain for legalization of marijuana itself. A number of judges and police officers are among those who think criminalization is a mistake.

Next year about two dozen volunteers will be allowed to inhale a small dose of cannabis as part of the first human clinical trials. They will be exempt from prosecution under the terms of a Home Office license.

Guy said he thought the beneficial effect of the drug occurred within the first minute of inhaling smoke from a joint, and that the psychotropic effect came only later once a much larger quantity had reached the brain.

Asked how he proposed to deliver the drug into the patient's system, he said: "I have changed my mind five times in the last six months." His current feeling was that inhaling brought fast pain relief.

"The smoking route is very, very intriguing indeed," he said. But he was not proposing any sort of reefer -- it would more likely be "something between an aerosol and a vaporizer." There were, however, people who claimed the effects of cannabis lasted longer if they ingested it orally.

Guy has spent some $16 million so far in his marijuana project and has invested in a Dutch medicinal marijuana breeding company called HortaPharm BV, which has the biggest "living library" of marijuana plants in the world. GW Pharmaceuticals is about to begin seeding in a secret, high-security greenhouse complex in the south of England.

Besides helping to lessen pain and spasticity, marijuana is also said to alleviate nausea in patients taking anti-cancer drugs. There is also evidence that it may stimulate the appetites of AIDS patients and assist in the treatment of glaucoma.


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