

NOTE: This is an archive site - we now have a new site.
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.
|