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Published 2008-05-15 16:20:00
 


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Swedish Prohibitionists Investigate British And Dutch Medical Cannabis Research;
But Omit Crucial Facts

(Ed. note: The Dutch government briefly got itself into an embarrassing situation, trying to duck the medical marijuana issue. In Holland, people with "prescriptions" can buy cannabis at a discount in some coffee shops. It is also reportedly available at some pharmacies, although the Dutch pharmaceutical system does not actually allow for this.

This has reduced the pressure on the Dutch government to get serious about medical marijuana. However, Dutch MS patients and others have been pushing to get research going on its medical use. At first, the government was so concerned about foreign pressure that it talked about importing marijuana from the UK -- and even the US, so as not to acknowledge that cannabis is grown in Holland. The cannabis from the UK would have been grown with Dutch seeds, so this was just too much. The Dutch government finally faced reality and is beginning research on medical cannabis using Dutch grown marijuana! Oh, somehow that is not reported by the Swedish prohibitionists.

Note the ludicrous statements of the UK government, as they follow the DEAland party line.)

Press release September 15, 1998
THE BRITISH GOVERNMENT AND CANNABIS

Following reports in the Dutch daily ‘Het Financieele Dagblad’ that the British government offered Dutch health minister Els Borst cannabis grown in Britain for research into the medical properties of the drug, Hassela Nordic Network contacted A D Macfarlane, Chief Inspector of the Action Against Drugs Unit with the British Home Office.
In a letter to R Lousberg, Chief Inspector for Health Care in the Netherlands, Macfarlane stated that the British Government has not offered anyone cannabis grown in this country or anywhere else;
the International Narcotics Control Board has not visited the Home Office to investigate any aspect of cannabis (marijuana) research; (This was confirmed by Mr. Fujino, Deputy Secretary of the Vienna-based UN agency International Narcotics Control Board (INCB) yesterday);
the British Government has the necessary technical and legal powers to licence cannabis research. Its Home Office Drugs Branch functions as the necessary organ under the United Nations Single Convention on Narcotic Drugs 1961 for that purpose.

What then are the conditions to be fulfilled for research in Britain into the medicinal effects of cannabis?

Material made available to Hassela Nordic Network by the British Home Office Drugs Branch outlines the conditions to be fulfilled as follows:
1. A research application should be submitted for joint scrutiny by the Department of Health and the Home Office;
2. The Home Office must be satisfied that the cannabis is in a form which is not readily recoverable or is administered in such a way (for example, only on hospital premises) that it is not available for misuse;
3. Any research project should be hospital-based and cleared by the relevant ethics committee;
4. Any dispensing facility should be confined to hospital pharmacy;
5. There should be a review period for the research;
6. Any project must use an appropriate scientific method (e.g. randomised controlled trials); and
7. Cannabis must be available in a suitable format for administration in controlled doses.

These conditions are in addition to the usual safeguards on safe custody and record-keeping which are required of Home Office licensees in respect of controlled drugs.

LICENSING CANNABIS FOR MEDICAL RESEARCH
The British Home Office has issued licences to Dr G W Guy under the Misuse of Drugs Act 1971, to research into the therapeutic use of natural cannabis. The licenses will be operated by the UK company GW Pharmaceuticals Ltd.
See
British Firm To Spend Huge Sums To Turn Medical Marijuana Into An Expensive Pharmaceutical While Arrests Continue
This is not the first licence to be issued for this purpose. There are four other licences currently held in the UK for the research into the therapeutic use of cannabis.
In addition there are 18 licences currently valid for cannabis research not directly related to medical research. They are held for academic purposes, according to the Home Office Drugs Branch.

GENERAL LINES ON THE USE OF CANNABIS FOR PALLIATIVE CARE

If and when the benefits of a cannabis-based medicine are scientifically demonstrated and a marketing authorisation is issued by the Medicines Control Agency, the Government would be willing to propose amendments to the misuse of drugs legislation to allow the prescription of such a medicine;
RAW CANNABIS WOULD NOT BE A VALID MEDICINE;
(Ed. note: Before the research, the conclusion.)
It would not be right to amend the misuse of drugs legislation to allow the prescription of a cannabis-based medicine, or any other potential medicine, unless or until its quality, efficacy, and safety have been established. In this we are treating cannabis no differently from other substances which are claimed to have therapeutic usefulness;
Mechanisms exist under the misuse of drugs legislation to allow research into the effects of cannabis under the Home Office licence.
Applications are scrutinised by the Home Office and the Department of Health and licensees are required to ensure that they meet the strict conditions as to the safe custody and record-keeping in respect of controlled drugs.

The British home Office has issued a licence for GW Pharmaceuticals, founded by Dr Geoffrey Guy. The company has been licensed under the Misuse of Drugs Act 1971 to proceed with a complete pharmaceutical research and development programme into cannabis and its chemical compounds, and in particular into delivery methods other than smoking. The objectives of the research and development programme will be: initially to develop standardised extracts of cannabis sativa (the most common cannabis plant), specially grown under controlled conditions;
to establish the best delivery method into patients, other than smoking, of cannabis and/or its constituents, and to establish if safe therapeutic uses exist in a range of illnesses;
(Ed. note: Before the research, the conclusion.)
to provide materials for clinical trials and extended monitoring programmes;
to prepare data for Product Licence Approval by the Medicine Controls Agency;
to expand the programme internationally with academic researchers and pharmaceutical partners;
eventually to identify purified fractions and/or subsets including single entities, which may have useful therapeutic applications or can serve as research tools.

All work will be carried out at secure research facilities in the UK.

Two licences have been granted, allowing GW Pharmaceuticals Ltd to operate a pharmaceutical development programme:
See
UK Will Not Arrest Medical Marijuana Users For Telling About Their Experiences – IoS --
But Dr. Guy Is Against Smoking It -- 2 Articles

A CULTIVATION LICENCE. This permits GW Pharmaceuticals to cultivate from seed or clones a range of cannabis chemovars (cultivars or races of cannabis defined by their particular chemical composition) in a highly secure glasshouse facility. GW will work on a scale representative of the quantity of materials required for pharmaceutical batch sizes. Strict Standard Operating Procedures have been agreed to ensure non contamination by chemicals, infestation or fungal growth, consistency of content, methods of harvest, drying, primary extraction, storage, and onward consignment.

POSSESSION OF SUPPLY FOR MEDICAL RESEARCH. This licence, under Section 7 of The Misues of Drugs 1971 Act, allows Dr Guy and GW Pharmaceuticals to store in a secure facility and dispense cannabis preparations for the purpose of research. It was granted after lengthy consultation with the Home Office and the Department of Health.

An additional research and development resource is recruited to carry out the programme the licence will be extended to cover those professionals nominated by Dr Guy and approved by the Home Office to perform specific sections of the programme. Such professionals will include analytical chemists, formulation pharmacists, Pharmaceutical Qualified Persons, clinical research associates, hospital pharmacists, and clinical investigators.

Under existing legislation, Schedule 1 drugs are those with high potential for abuse and no therapeutic value, such as Ecstasy. Schedule 5 drugs are those containing very limited amounts of certain controlled drugs. As a Schedule 2 drug, use of cannabis and/or its constituents could be restricted, in the same way as morphine, but not banned.

GW PHARMACEUTICALS Ltd has recently negotiated a world wide collaboration with the Dutch medicinal cannabis breeding specialists HortaPharm B.V., who have extensive experience in the cultivation and standardisation of cannabis sativa for medical purposes.

DR GEOFFREY GUY is a Pharmaceutical Physician with 18 years experience in pharmaceutical development covering New Chemical Entities, Biotechnology products, plant based medicines and drug delivery systems. Dr Guy has been the physician in charge of over 250 clinical studies including first dose in man, pharmacokinetics, pharmacodynamics, dose ranging, controlled clinical trials, and large-scale multi-centered studies and clinical surveys. Specialist areas of interest include Narcotic Analgesics, Hormone Replacement Therapy, Asthma and eczema. Dr Guy was the founder of the pharmaceutical drug delivery group, Ethical Holdings plc, and of Phytopharm Ltd, a phytomedicines company. Dr Guy has established GW Pharmaceuticals LTD in the UK solely to operate its Home Office Cannabis Medical Research Licences.

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