| You
are in Medical GW
Pharmaceuticals | |
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| "My
professional view of cannabis as a substance is that it appears to be a remarkably
safe substance in comparison to most medicines prescribed today. The more I learn
about this plant the more fascinated I become. It has through its various constituents
multiple effects of therapeutic interest, many of which are now being validated
by the enormous growth in basic cannabinoid research." - Dr Geoffrey
Guy, Chairman of GW Pharmaceuticals. | | | |
On
the 11th of June 1998, the campaign for the availability of medical marijuana
received a boost, as a UK-based company, GW Pharmaceuticals received a license
from the Home Office in order to conduct research into the medicinal uses of cannabis.
The company had noted the large amounts of evidence that cannabis has beneficial
effects on a number of medical symptoms. They then set out to conduct controlled
clinical trials to evaluate these with a view to producing a final product to
bring relief to thousands of sufferers to whom existing pharmacological treatments
do not suffice. GW Pharmaceuticals thus became the only company in the UK licensed
to provide raw cannabis materials for trials.
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Is this legal?
Research on medicinal cannabis
is generally forbidden under the Misuse of Drugs Act 1971. GW Pharmaceuticals
applied to the Home Office in order
to receive permission to conduct these vital trials. They receieved two licences:
A Cultivation Licence, allowing GW Pharmaceuticals to grow cannabis plants
from seed or by cloning, subject to strict conditions.
A Possession and
Supply for Medical Research licence allowing GW Pharmaceuticals to store cannabis
in specified secure conditions, and supply the stored cannabis solely for research
purposes. | | GW
Pharmaceuticals then collaborated with the Dutch plant-breeding company Hortapharm
which allows GW Pharmaceuticals to use any of Hortapharm's cannabis plant varieties,
and provide assistance in the cultivation of their own, in return for the development
of devices to safely administer the cannabis medication into patients.
The first
cannabis seeds were sown in July 1998, and by November 1998, GW Pharmaceuticals
had a healthy crop of 5000 cannabis plants growing in the agreed secure storage
structure in the South of England. It was thought that during the research about
20000 plants would be needed, most of which would be cloned off the 5000 grown
from seed. In
January 1999 the first harvest was taken. Plants were cut off above the stem,
dried, and then transferred to a laboratory. In
June, an application was made for GW Pharmaceuticals to establish a partner company
in Canada to continue its investigations in more detail. |
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November, the clinical trials were well underway. According to the company, humans
were monitored whilst ingesting different extracts of cannabis through varied
delivery devices for the first time. This formed part of the Phase 1 trial which
was completed without problems. The results of this study allowed the selection
of the best cannabis extracts for further testing. Significant differences may
be expected in the effectiveness of plants which differed in the ratios of the
cannabinoids. | | | |
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The trial procedure As
with any other medication, for cannabis to be 'officially' proved an effective
and safe medicine, it needs to go through several medical trials. These typically
occur in 3 phases.
Phase 1 establishes the 'safety' of the drug. Healthy
subjects ingest variable amounts of the drug and their physical functions are
monitored to ensure no harm occurs to them. As a result of this, a safe dose-range
can be established.
Phase 2 establishes the 'efficacy' (effectiveness)
of the medication in potential patients. A small group of people suffering from
the relevant affliction are medicated and studied to see whether the drug is in
any way effective. This allows sensible tests to be developed and provides a mechanism
for interpreting results.
Phase 3 involves much larger scale trials
involving hundreds of potential patients. Typically comparisons between the active
compounds, placebos and different medicines are taken. Special issues are considered
such as special target patient groups (e.g. children) and interactions with other
drugs.
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| By
April 2000, GW Pharmaceuticals had received a clinical trial exemption certificate
from the Medicines Control Agency. This was permission from the UK medical authorities
to start a Phase 2 trial, involving patients who had multiple sclerosis, severe
pain, spasticity and related conditions. The trials took place in several locations
but commenced in Great Yarmouth's James Paget Hospital, initially under supervision
by Dr Willy Notcutt. In this case, the trial was to establish the effectiveness
of pain relief using a cannabis-based sublingual spray. Trials soon expanded into
other areas of the country, including their first 'off-shore' research location
in Guernsy. Overall,
the Phase 2 trials went well, and by May 2001 started its Phase 3 trials, involving
many more patients living in more diverse locations. Hundreds of patients were
involved, in a cross-country coordinated study based in Oxford. At this stage,
£12 million had been spent on the trials, and the company hoped to be able
to produce its first authorised prescription medicine in 2003, which would be
targeted at patients who suffered from Multiple Sclerosis, arthritis, cancer pain
and spinal cord injuries amongst others. This medicine would as far as possible
attempt to try and let the patients gain medical benefits without psychoactive
'side effects' and without the health dangers related to smoking. The method of
delivery was such that the patients could adjust their doses individually to provide
the best level of benefit without side effects. In addition the company received
an Investigational New Drug approval from Health Canada, allowing them to commence
further Phase 2 trials in Canada - the first step in the 'international roll-out
of GW's product activity'.
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Administration Many
self-medicating patients smoke cannabis in order to relieve their symptoms, as
this allows quick action and an easy method of dose titration. However, smoking
does produce unwanted side-products such as tars. To avoid these, GW Pharmaceuticals
have looked into other methods of ingestion. These include:
Sub-lingual
spray - allows patients to spray their medication under their tongue using
a conventional medical spray.
Sub-lingual tablet - a pill patients
let dissolve under their tongue.
Inhaler - an electrical inhalation
device allowing patients to 'smoke' their medication without the associated tars
etc, in a similar vein to a vapouriser.
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At the same
time, GW Pharmaceuticals were seeking admission into the Alternative Investment
Market of the London Stock Exchange. They wished to raise £16 million from
investors, in order to fund the expansion of the already-large trials, their cultivation
and production facilities and to allow research to take place in other places
in Europe and America. They gained entry to the Stock Exchange and floated with
unprecedented success - raising £25 million from investors, showing perhaps
the interest, excitement and practical success of the trials so far. The
general success of the trials gives hope of a change of law allowing thousands
of sufferers to relieve their illness via a relatively safe medication. The
current Phase 3 trials some of GW Pharmaceutical's products are going through
are in effect the final stage in preparing an application to the Medicines Control
Agency for a Product Licence Approval | |
This Product
Licence is an endorsement by the medical authorities of the UK that a medicine
is safe and effective. The Government still has the final say - even when cannabis
has been proven to be an unusually safe and effective medicine, it still won't
be able to be used under the current law. However, the UK Government has indicated
that if GW Pharmaceuticals are granted a licence, it would be willing to change
the Misuse Of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine.
This
has lead GW Pharmaceuticals to suggest in 2001 that the day you can walk into
your Doctor's office with a severe medical complaint and receive a prescription
for legal, pure, safe and affordable cannabis-based medication may only be 2 or
3 years away. 2010
update Sativex
still hasn't been properly licenced as a medicine, but was made avaiable in 2006.
It can now be prescribed, but is very hard to get. For
more information, see GW
Pharmaceuticals official website. | |
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