Peter Reynolds

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CLEAR and GroGlo Establish First UK Clinical Trials on Cannabis for Chronic Pain.

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groglo banner

CLEAR has formed a partnership with the research arm of GroGlo, a UK-based manufacturer of high power, LED, horticultural grow lighting.

The plan is to grow cannabis under a Home Office licence for the production of cannabis oil, both as a dietary supplement and for the development of medical products.  To begin with, a low-THC crop of industrial hemp will be planted.  We will be using the finola strain, originally developed in Finland and known for its short stature and early flowering. Unlike hemp grown for fibre, finola is usually grown for seed and only reaches a height of 160 – 180 cm but we will be removing male plants before they produce pollen and cultivating the female plants to produce the maximum yield of oil from their flowering tops.

Finola Industrial Hemp

Finola Industrial Hemp

The low-THC oil will be marketed as a dietary supplement, commonly known as CBD oil. There is already a burgeoning market in the UK for CBD products, all of which is currently imported from Europe or the USA.  In the USA, the CBD products market was said to be worth $85 million in 2015 so there is huge potential here at home. Aside from the benefit of being UK grown and processed, we anticipate achieving a CBD concentration of about 40%, which is higher than most products already on the market.

Cultivation will be in glasshouses supplemented with LED lighting.  GroGlo already has an established glasshouse facility in the east of England.  Initial trials will experiment with adjusting the LED technology to provide a changing blend of light wavelengths at different stages of plant growth.  This is GroGlo’s area of expertise -combining LED lighting and plant sciences, including existing relationships with some of Europe’s top universities. Professor Mick Fuller, GroGlo’s director of plant science, will lead this research and development process.

Professor Mick Fuller

Professor Mick Fuller

During the R&D phase, CO2 extraction of oil will be carried out under laboratory conditions at universities in York and Nottingham which already have extensive experience of the process. Each crop will be measured for yield, cannabinoid and terpene content using high pressure liquid chromatography (HPLC).  Safety testing will also look for the presence of heavy metals and other contaminants.  The results of testing will be fed back into cultivation and extraction processes to maximise yield and quality.

It is anticipated that the first batches of low-THC oil will be ready for market in six months.  We are already in discussions with potential distributors and wholesalers. The CBD market in the UK is ripe for an effective marketing campaign which could build a very substantial business for whoever gets it right.

Once we are successfully achieving our production goals with low-THC cannabis, the same testing and development process will begin with high-THC varieties of cannabis.  The aim will be to produce a range of oils extracted from single strains, selectively bred and stabilised for different THC:CBD ratios.

Professor Fuller says that GroGlo lighting products “are in use worldwide to grow a range of crops, but some 60% of sales currently come from overseas users growing cannabis for legitimate medical use.”  He explains that there is an emerging market for all sorts of nutritional and medicinal plant products but cannabis shows particular promise. GW Pharmaceuticals is the only UK company to enter this market and it has become a world leader, despite the current restrictive legislation.  He says:  “Together with CLEAR we believe we can help bring a range of safe, high quality UK-produced cannabis products to market within a matter of two to three years.”

A key issue in the development of a successful medicinal cannabis product is the method of delivery.  Smoking is not an acceptable solution as inhaling the products of combustion is an unhealthy practice but one of the great benefits of cannabis smoked as medicine is very accurate self-titration.  That is the effects of inhaled cannabis are felt almost instantly and so the patient knows when they have taken enough or when they need more to achieve the required analgesic effect.

The oral mucosal spray developed for Sativex is unpopular with patients, many complain of mouth sores from its use and it was developed at least as much with the objective of deterring ‘recreational’ use of the product as with delivering the medicine effectively. It strangles the therapeutic benefits of the cannabis oil of which Sativex is composed in order to comply with the concerns of the medicines regulators about ‘diversion’ of the product into what they would term ‘misuse’.  Absorption of the oil is quicker through the mucous membranes of the inside of the mouth than through the gastrointestinal system but, inevitably, some of the oil is swallowed and the pharmacology of cannabis when processed through the gut and the liver is very different.

We believe the best option is a vapouriser device and our intention is to source a ‘vape pen’ of sufficient quality to operate within clinical standards of consistency and safety. Vapourising cannabis oil avoids inhaling the products of combustion but still enables accurate self-titration of dose.  A vape pen would provide a handy, convenient and very effective method of consuming medicinal cannabis.  However, aside from the technology itself, initial research shows that vapour is more effectively produced when the oil is blended with either vegetable glycerin (VG) or propylene glycol (PG).  Establishing the correct ratio of VG or PG to the oil is another important task.

We anticipate that clinical trials for the use of cannabis oil in treating chronic pain could start within two years.  We want to compare different oils, ranging from high-CBD to equal ratios of THC:CBD and high-THC content. Prior to that we have to overcome the challenges of cultivation, oil extraction, vapouriser development and assemble the necessary research team and gain ethical approval for the trials.  Recruitment for the trials will start in about 18 months time.  If you wish to be considered please email ‘paintrials@clear-uk.org’ with brief details of your condition (no more than 100 words). Do not expect to hear anything for at least 12 months but your details will be passed to the research team as a potential candidate.

Mike Harlington, Managing Director of GroGlo

Mike Harlington, Managing Director of GroGlo

CLEAR is promoting this venture simply because someone needs to do something to make this happen. For all the campaigning and lobbying of MPs and ministers, at the end of the day, the plants have to be grown and the various legislative hoops have to be jumped through. We cannot wait any longer for a radical change in the law. We have to progress through the government’s regulatory regime if we want to bring real therapeutic benfit to patients.

This opportunity arises because of the vision of GroGlo’s managing director, Mike Harlington and the team of experts he has built around him. There is huge demand for legitimate medicinal cannabis products in the UK which is only going to increase with the inevitable progress towards law reform and increasing awareness of the benefits of cannabis. Together, CLEAR and GroGlo are bringing the great hope that medicinal cannabis offers closer to reality than ever before.

 

The CLEAR Cannabis Law Reform Campaign.

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CLEAR home page regulation slider

In five years, CLEAR has transformed the UK cannabis campaign from a ragtag group of protestors into a coherent, science and evidence-based strategy. New groups pursuing similar, responsible advocacy have emerged such as the United Patients Alliance (UPA) and most recently End Our Pain (#EndOurPain).  In the last three years, in government and Parliament, there has been more liaison between the campaign, ministers and senior politicians than in the last 50 years.  The Liberal Democrats have formally adopted policies which are almost identical to those enshrined in CLEAR’s aims and objectives.

Fundamental to CLEAR’s work has been the publication of evidence and the development of plans based on consultation with consumers, patients, doctors, scientists, academics and other experts.

These three publications form the basis for all our work.  Please download them, read them, share them and use them as widely as you can.  Together they defeat all the arguments for the continuing ban on cannabis.

ttukcm thumbnailTaxing the UK Cannabis Market

The most authoritative, independent, expert research on the UK cannabis market by the Independent Drug Monitoring Unit, commissioned by CLEAR in 2011.

 

 

 

 

 

htrcb thumbnailHow To Regulate Cannabis In Britain

This is the second version of a plan for the regulation of the cannabis supply chain in Britain. This version was published on 18th October 2013

 

 

 

 

 

mcte thumbnail fcMedicinal Cannabis: The Evidence

The most up-to-date, comprehensive analysis of the evidence on the safety and efficacy of cannabis as medicine. Focuses on Alzheimer’s disease, cancer, chronic pain, Crohn’s disease and multiple sclerosis. Published April 2015.

CLEAR Withdraws Its Endorsement of UK CBD.

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uk cbd cannabinoid nutraceuticalsCLEAR can no longer endorse or recommend UK CBD as a supplier of CBD products.

This decision is made with regret but is unavoidable due to a number of problems which, despite our best efforts, have proved impossible to resolve.  Our endorsement was based on UK CBD’s ethical and quality standards but the position has changed and the directors of UK CBD have been unable satisfactorily to address our concerns.

Our main concern is that certain products marketed by UK CBD contain such high levels of the controlled drugs THC and CBN that we consider them to be unlawful.

One particular product, UK CBD 710 Cannabinoid Crystals, is being promoted as containing “over 4mg of THC”.  Anyone importing, supplying or in possession of this product risks criminal prosecution.

Potentially this product could destroy the whole CBD market.  If a prosecution was brought under the Psychoactive Substances Act 2016, it could result in all CBD products being regarded as psychoactive.

CLEAR strongly supports the developing CBD market as a legal alternative to high-THC products.  However, it is vital for the security of consumers that products comply with the law.

Written by Peter Reynolds

March 14, 2016 at 4:43 pm

A CLEAR Response To the Liberal Democrats’ Proposals For Cannabis Regulation.

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libdem Framework_for_cannabis thumbnail

CLEAR welcomes the Liberal Democrats’ proposals which can be seen here. We set out below a few comments which we intend to be constructive.

We represent more than 600,000 people who support cannabis law reform. Our own publication, ‘How to Regulate Cannabis in Britain’ is now in its second edition.

It is based on independent, expert research which we commissioned from the Independent Drug Monitoring Unit, published as ‘Taxing the UK Cannabis Market’.

Comments on ‘A framework for a regulated market for cannabis in the UK’

1. We support a cautious approach and agree that it is better to start with stricter regulation that could, based on experience, be relaxed at a later date if appropriate.

Spectrum of Cannabis Policy

Spectrum of Cannabis Policy

We reject the diagram ‘Exploring a spectrum of options for regulating cannabis’ which paints an inaccurate picture of the effects of a legal market. Evidence from all jurisdictions that have implemented reform does not support the equivalence of ‘social and health harms’ with ‘ultra prohibition’ and ‘commercial production’. It is absolutely clear that legally regulated commercial production is far less harmful than prohibition.

Essentially, instead of a ‘U’ shaped curve, we consider an ‘L’ shaped curve is more accurate.

2. The diagram indicates a fundamental objection to the commercial model implemented in Colorado, Washington and Oregon and the report explicitly rejects the Colorado model in favour of the Uruguay model.

We disagree with this. The Colorado model is a proven success with virtually no downsides. The Uruguay model is still a theory which is yet to be proven in practice. This conclusion in the report is therefore not evidence-based. This suggests that wider political or philosophical considerations have been allowed to trump existing evidence.

3. We are concerned about the undue weight given to restricting commercial enterprise. The UK is not a socialist economy and there is a danger of a ‘nanny-state’ attitude which we cannot support. We repeat the point that it seems wider political or philosophical considerations have been allowed to prevail over actual evidence. There needs to be a balance between a ‘cautious approach’ as in 1. above and over-regulation which will only result in a continuing criminal market. The UK is a market economy and if the legal market is too strict and rigid, the illegal market will flourish.

4. We have very grave concerns about the cannabis social club (CSC) model which provides significant opportunity for the corruption of those involved into major criminal enterprises with exploitation of both workers and customers. The establishment of such ‘clubs’ is entirely unnecessary given the other more controllable methods of supply and will only lead to diversion and perhaps active marketing of excessive production through criminal networks. In other words, CSCs are a golden opportunity for the emergence of ‘drug pushers’ and they undermine the whole purpose of cautious regulation.

5. We regard the recommendation not to permit the production and marketing of ‘edibles’ as an error. If the other recommendations making raw herbal cannabis legally available are implemented then this will inevitably lead to the production and marketing of unregulated ‘edibles’, undermining the whole purpose of regulation. Far better to learn from the mistakes already made in excessively potent ‘edible’ products and introduce appropriate regulations with reduced dosages.

If anything, ‘edibles’ need regulation far more urgently than the raw product because of the potential for very unpleasant overdosing. To abrogate responsibility for this is an extremely unwise proposal and inconsistent with the whole basis for a regulated market.

6. We would encourage a more positive and supportive approach to enable producer countries such as Morocco, the Lebanon, Pakistan and Afghanistan to supply varieties of cannabis resin and hashish. Encouraging such trade under strict regulation will further undermine criminal activity and offers great potential for better relations and positive ‘soft power’ influence on these countries. We recognise the difficulties involved in this with regard to the UN conventions but consider it is a prize worth working towards.

7. For the same reasons set out above we consider that a refusal to regulate concentrates and vapouriser products undermines the whole purpose of a regulated market. Vapouriser products are almost certainly going to be an important component of the medical cannabis market. These nettles must be grasped. To avoid them is irresponsible.

8. We would argue for far more emphasis on harm reduction information, particularly about smoking and avoiding mixing cannabis with tobacco. As in 7. above, we would actively promote the choice of vapouriser products.

9. In principle we agree with the proposal for three levels of THC content and for minimum CBD content. However, there is no evidence to support the necessity for CBD content as high as 4%. The evidence suggests that levels of 1% or 2% adequately meet the desirable ‘entourage’ effects of CBD. Furthermore, at these levels, existing strains are available. Little consideration has been given to the practicalities of developing three new strains to meet the THC:CBD ratios proposed. To develop such strains and ensure they are stable and consistent is the work of several years, requiring significant investment and so undermines the ability to implement these proposals in timely fashion.

10. We consider that the ‘plain packaging’ proposal is unnecessarily restrictive in the UK’s market economy. We agree with child proof containers but would recommend that far more emphasis is given to content and harm reduction labelling. There is nothing to be gained from restricting the marketing and commercial enterprise of companies wishing to develop brands and packaging styles within strict regulations.

11. For reasons already set out we consider that the restrictions on exterior and interior retailer environments are oppressive and will be self-defeating. The UK is not accustomed to such overbearing and anti-business regulation. Existing pharmacies do not operate under such heavy restrictions and they make significant use of point-of-sale and merchandising techniques.

Overall, we welcome this document and the proposals it contains. One final point that is of significance is that clearly there was no ‘consumer’ representation on the panel and this is obvious in some of the tone and detail of the report. We recommend that account should be taken of consumer opinion in any future development of the proposals.

Tim Farron. Another Politician Displays Total Ignorance About Cannabis.

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Tim Farron on BBC's Victoria Derbyshire show

Tim Farron on BBC’s Victoria Derbyshire show

It is truly pathetic to see.  Farron clearly understands the huge harm caused by cannabis prohibition but doesn’t have the knowledge, the courage or the integrity to speak the truth.  Instead he panders to to the scaremongers and says:

“Cannabis causes psychosis”

“Cannabis is dangerous”

“People who use cannabis have a health problem”

“Cannabis is a bad thing”

The Liberal Democrat’s report ‘A framework for a regulated market for cannabis in the UK: Recommendations from an expert panel’ is a re-hash of Transform’s ‘Blueprint’ and its work on a socialist model of cannabis regulation in Uruguay.  It denigrates the highly successful commercial model introduced in Colorado and follows Transform’s evidence-free exaggeration of the harms of cannabis and its determination to impose anti-business controls on a legal cannabis market.

There is no evidence that cannabis causes psychosis.  The most that can be said is that in a very small number of genetically-vulnerable people, it may be one of many ‘component causes’.

There is no evidence that cannabis is dangerous.  The most that can be said is that it does have the potential for harm if used by children, to excess, irresponsibly or by a tiny group of people who may have an allergic reaction.  If you describe cannabis as dangerous then you have to describe peanuts, aspirin and hay fever remedies as more dangerous.  That’s without even considering comparison with the two most dangerous drugs of all: tobacco and alcohol.

Some people who use cannabis have a health problem and they use cannabis for its remarkable properties to relieve pain and other symptoms.  For most people, in moderation, cannabis is actually beneficial, helping to protect against autoimmune conditions, cancer, dementia and other diseases of aging.

For at least 95% of people who use cannabis they do so safely, without any negative consequences and it is a very good thing for their health and wellbeing.

Written by Peter Reynolds

March 8, 2016 at 11:21 am

Top Jersey Doctor Misinforms and Misleads On Medicinal Cannabis.

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Dr Nigel Minihane

Dr Nigel Minihane

Dr Nigel Minihane is the head of Jersey Primary Care Trust which represents all GPs on the island.  Recently he contributed supposedly ‘expert opinion’ to an article in the Jersey Evening Post about someone who had been juicing raw cannabis for therapeutic reasons.  His comments demonstrate an ignorance and lack of knowledge which is unacceptable in a doctor in such a senior position.  In conjunction with CLEAR members in Jersey, we have submitted a formal complaint.

JEP PCT 1

JEP PCT 2

Jersey Evening Post, 13th February 2016

Dear Sirs,

On behalf of our members in Jersey, we wish to bring a complaint of misconduct against Dr. Nigel Minihane concerning comments attributed to him and published in the Jersey Evening Post on 13th February 2016.

The article in question is attached to this email. The passage we are concerned about is at the very end of the article where Dr Minihane gives false information about a recent drug trial in France which resulted in one death and several people suffered brain damage.

The trial to which Dr Minhane refers was not “of a cannabinoid substance”, it was of an FAAH inhibitor, known as BIA 10-2474. This drug is designed to inhibit the natural degradation of endocannabinoids, leading, it was hoped, to pain relief through modulation of the CB receptor network. It was therefore neither a cannabinoid substance nor cannabis. See: http://www.nature.com/news/scientists-in-the-dark-after-french-clinical-trial-proves-fatal-1.19189

Dr Minihane’s words were therefore inaccurate and misleading and contribute to the prejudice and misunderstanding around the use of cannabis and cannabinoids as medicine. Dr Minihane is, of course, entitled to his opinion but based on his other comments in the article he is clearly very poorly informed on the subject. There is a vast amount of peer reviewed, published evidence which supports the safety and efficacy of cannabis and cannabinoids as medicine. See attached paper ‘Medicinal Cannabis: The Evidence’. Furthermore, it is well established in the evidence that cannabis is physically addictive, with about 9% of regular users developing dependence which is characterised by physical withdrawal symptoms including insomnia, lack of appetite and headache.

We understand that Dr Minihane is head of the Jersey Primary Care Trust and the Jersey Evening Post will have asked him to provide an expert opinion. The information he provided was inaccurate, misleading and reckless. In our view it falls well below the professional standard that one is entitled to expect from any doctor. It is woefully inadequate in the case of a doctor in such a senior position who holds himself out as an expert yet communicates false information to the public through the media.

We would be grateful if you would consider this complaint at your earliest opportunity. We are able to provide oral evidence in support and to suggest witnesses resident in Jersey who endure unnecessary pain and suffering due to medicinal conditions that coud be treated by cannabis if the PCT was properly assessing and considering the evidence.

Yours faithfully

Peter Reynolds
President

Written by Peter Reynolds

February 25, 2016 at 10:25 am

GW Founder And Chairman, Geoffrey Guy, Explains Sativex.

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geoffrey guy caption

“Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”

Source

Written by Peter Reynolds

February 14, 2016 at 12:27 pm

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