Source: British Medical Journal (UK)
Contact:  1 Aug 1998
Issue: BMJ 1998;317:302 (1 Aug 1998)

POSSIBLE CANNABIS RESEARCH IN BRITAIN

News extra: Some encouragement given for research into cannabis (John
Warden, parliamentary correspondent, BMJ)

The Home Office indicated last week that it is willing to set up "workshop
talks" to discuss licensing procedures for research into the medical use of
cannabis, and the Medical Research Council said that it would consider
special treatment for clinical trials. The offers were made when both
bodies gave evidence to the House of Lords subcommittee that is inquiring
into possible changes in the law relating to cannabis and its derivatives
for medical and recreational purposes. Home Office officials said that they
are making arrangements with the Department of Health and the Medicines
Control Agency (MCA) for a conference to discuss aspects of research
licensing with representatives of the research community. The aim would be
to highlight some of the complex issues involved such as the supply of
standardised cannabis and the adoption of sound methodologies. If and when
the benefits of a cannabis based medicine had been scientifically proved
and a marketing authorisation issued by the MCA, the Home Office said that
it would be willing to come forward with a change in the law to allow the
prescribing of such a medicine. Professor George Radda, the chief executive
of the MRC, told the committee that the council did not get many valid
applications for research into the therapeutic use of cannabis, although it
would be prepared to give them special consideration. It was looking into
the possibility of carrying out some preliminary trials at Exeter
university. In addition, the committee set up by the Royal Pharmaceutical
Society under Sir William Asscher (2 May, p 1335) had agreed to focus on
the reduction of pain and spasticity as the end point of possible clinical
trials and committee members were debating which products to investigate.
They were in process of discussing good protocols. In a written submission,
the MRC said that in the absence of data, the scientific evidence in favour
of permitting the medical use of cannabis or cannabinoids must be
considered slight at the moment. Lord Walton of Detchant observed that the
subcommittee had not had any convincing evidence that cannabis had any
effect on the course of a disease.

BMJ 1998 316: 1333. [Full text]:

Research into the clinical use of cannabinoids is to be put on to a new
basis in Britain with the formation of a committee of experts who will draw
up guidelines for good practice.

The working party on the therapeutic uses of cannabinoids is being set up
by the Royal Pharmaceutical Society of Great Britain and will be headed by
Sir William Asscher, a former chairman of the government Committee on
Safety of Medicines. The aim is that the guidelines will encourage the Home
Office to approve research licences which are currently being delayed.

The development was reported by BMA witnesses to a House of Lords
subcommittee inquiring into the use of cannabis and its derivatives for
medical and recreational purposes and into whether any relaxation of the
law is appropriate. Last year the BMA report Therapeutic Uses of Cannabis
concluded that cannabis is unsuitable for medicinal use but that
cannabinoid derivatives should be considered. Dr Vivienne Nathanson, head
of the BMA's professional resources and research group, and Professor
Heather Ashton, consultant writer for the BMA report, gave evidence to the
Lords subcommittee last week. They reported a meeting last month with the
chief medical officer at the Department of Health to discuss further action
in moving forward clinical trials of cannabinoids. It was agreed that a new
independent body to conduct such trials was required.

Dr Nathanson welcomed the Royal Pharmaceutical Society's working party as a
means of producing better research and development of cannabinoids so that
the least possible delay occurs before clinical trials are started. Concern
had been expressed, she said, over Home Office delays in issuing research
licences, with about 14 applications pending.

The new research protocols might help the Home Office to compare licence
applications with a set of guidelines and decide which should be licensed.
In a written submission, the BMA said that individual cannabinoids have a
therapeutic potential in several medical conditions in which present drugs
are not fully adequate.

The long term effects have not been studied, but present evidence indicates
that cannabinoids are remarkably safe. The accumulation of scientific
evidence has been hampered by regulations restricting the use of
cannabinoids to one clinical indication--as antiemetics in chemotherapy for
cancer. The BMA wants a high priority given to carefully controlled trials
of cannabinoids in patients with chronic spastic disorders that have not
responded to other drugs.

In the meantime there was a case for the extension of the indications for
nabilone and [delta]-9-tetrahydrocannabinol for use in chronic spastic
disorders unresponsive to standard drugs.

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Checked-by: Mike Gogulski