Posts Tagged ‘medicinal cannabis’
CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis
This was the response that CLEAR submitted to the APPG in February 2016. In March 2016, Roland Gyallay-Pap, then managing director of CLEAR and Peter Reynolds, president, were called to give oral evidence to the Inquiry.
A PDF copy of this document may be downloaded here.
Introduction
In June 2015 the All-Party Parliamentary Group for Drug Policy Reform (APPG) published a short report arguing for a rescheduling of cannabis to make it more widely available for medical use. Following the publication of that report there are a number of key questions remaining that it would like to address by means of a Short Inquiry.
CLEAR Cannabis Law Reform has been asked to submit evidence to the Inquiry in answer to these specific questions:
- Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
- What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
- What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
- Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
- What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
- What role could EU regulations play in developing the potential for the medicinal use of cannabis?
We have also added a further response with additional information.
- Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
Yes, we consider that switching cannabis from schedule 1 to a less restrictive schedule would be beneficial, both so that it could be prescribed by doctors as medicine and so that it could more easily be used in research into its use and effects.
Cannabis has been in schedule 1 of the Misuse of Drugs Regulations1 (MoDR) since the Misuse of Drugs Act 19712 (MoDA) came into force. Drugs in schedule 1 are specified as having no medicinal value. However, an inquiry by the House of Lords Science and Technology Committee published in 19983 recommended that doctors should be permitted to prescribe cannabis and that it should be moved to schedule 2. Strangely the government’s response to this recommendation was further to tighten restrictions by the Misuse of Drugs (Designation) Order 20014, which designates cannabis under section 7(4) of MoDA so that it is unlawful “for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply” it.
In fact, cannabis has already been re-scheduled into schedule 4 under the international non-proprietary name of nabiximols (Sativex)5. Although this is specified as being an extract of THC and CBD, it is clear from statements by the manufacturing company, GW Pharmaceuticals, that nabiximols is whole plant cannabis. Dr Geoffrey Guy, founder and chairman of GW, is on the record:
“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.”6
GW pharmaceuticals has confirmed that this quotation is accurate.7
The MHRA has chosen to issue a marketing authorisation8 for nabiximols (Sativex) by regarding it as only a two molecule medicine. The marketing authorisation is therefore at best inaccurate, at worst dishonest.
What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
In 2011, CLEAR commissioned independent, expert research from the Independent Drug Monitoring Unit (IDMU). The report, ‘Taxing the UK Cannabis Market’9, reveals there are three million people using cannabis in the UK regularly (at least once per month). Since then CLEAR has regularly polled its members and followers and consistently one in three of respondents claim at least some part of their use is for medicinal reasons. It is reasonable to estimate therefore that there are up to one million people using cannabis for medicinal purposes in the UK. It is certain that there are hundreds of thousands of medicinal users and previous estimates in the region of 30,000 are far too low.
The most common indications for medicinal use declared by our respondents are chronic pain, fibromyalgia, Crohn’s disease, multiple sclerosis and cancer.
Our interpretation of the responses we have received is that generally cannabis is used as a palliative agent. Some people find it so effective that they consider it to be a ‘cure’ as long as they keep using it. Others find it extremely helpful in reducing the amount of toxic and/or dangerous pharmaceutical medicines they are prescribed. Often the side effects of pharmaceutical medicines are severe and debilitating and cannabis offers a way of minimising these.
CLEAR maintains a Medicinal Users Panel10 which members join in order to gain support in lobbying their MPs and/or attempting to obtain prescribed Bedrocan medicinal cannabis. The active membership of the panel varies between 20 to 80 people. Panel members have also been involved in delegations to meet government ministers and other parliamentarians
What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
In the UK there is very little research into the medicinal uses of cannabis, except that undertaken by GW Pharmaceuticals11. There has been some research carried out into single cannabinoids but the evidence is that the therapeutic effects of cannabis depend on the whole plant ‘entourage effect’.
The allopathic, reductionist approach to medicine, which is reflected in the way that the MHRA regulates medicines, is the fundamental, establishment doctrine that impedes research into cannabis.
Sadly, one of the biggest trials of MS patients, the CUPID study at the University of Plymouth12, intended to look at the many anecdotal reports of benefit, used synthetic THC and consequently the results were disappointing and irrelevant to the claims it sought to test.
It is far easier to obtain funding for research into the harms of cannabis which is undertaken with an almost absurd degree of repetition, most notably by the Institute of Psychiatry at King’s College London (IOPPN).13 It is also worth noting that IOPPN regularly and consistently overstates the results of its research, encouraging the media to report causal effects between cannabis use and mental illness which its research does not support.14
There is a huge stigma around cannabis, largely due to inaccurate, misleading and hysterical press coverage. For instance, neither of the pre-eminent MS patient groups, the MS Society and the MS Trust, will take a stand in support of patients, despite the fact that many use cannabis. Similarly, despite extraordinary human clinical trial results on Crohn’s disease, none of the Crohn’s patient groups will engage with the campaign. Mention cannabis and calls are not returned, people are scared by the stigma. The immediate reaction from all such patient groups is to overlook evidence of benefit and refer to risks to mental health which, in fact, are very low compared to pharmaceutical products. The press, unchallenged by politicians in its disproportionate attention to these risks, bears a heavy responsibility for this stigma and the lack of research.
Unlike many within the reform movement, CLEAR recognises and values the expertise and achievements of GW Pharmaceuticals. However, any doctor or scientist that expresses any interest in medicinal cannabis in the UK is immediately retained or contracted by GW. We receive hundreds of reports of doctors, GPs and consultants, who tacitly and sometimes explicitly support their patients’ use of cannabis but it is impossible to find any doctor who is prepared to speak out publicly. In the few instances where doctors have spoken out on behalf of patients, they have been contacted by Home Office officials and warned. One GP reported that he felt “intimidated”. By contrast, there are tens of thousands of doctors across Europe, Israel and North America who advocate for the use of medicinal cannabis and further research into its applications.
The security and record-keeping requirements for cannabis as a schedule 1 drug15 are wildly disproportionate to the real potential for harm, requiring a high security safe for storage and an audit trail fit for Fort Knox.
In addition the fee for a high THC licence is currently £4700.00 per annum and applications can take more than a year to process. These requirements, delays and corresponding costs severely impede research into medicinal cannabis.
Recently, in response to two government e-petitions, the Home Office issued the following statement:
“In 2013 the Home Office undertook a scoping exercise targeted at a cross-section of the scientific community, including the main research bodies, in response to concerns from a limited number of research professionals that Schedule 1 status was generally impeding research into new drugs.
Our analysis of the responses confirmed a high level of interest, both generally and at institution level, in Schedule 1 research. However, the responses did not support the view that Schedule 1 controlled drug status impedes research in this area. While the responses confirmed Home Office licensing costs and requirements form part of a number of issues which influence decisions to undertake research in this area, ethics approval was identified as the key consideration, while the next most important consideration was the availability of funding.”
We consider this response to be disingenuous and misleading. Cannabis is a special case. It is a combination of hundreds of molecules, unlike other schedule 1 drugs, most of which are single molecules. Also, as is well established in written and archaeological evidence, cannabis has been used effectively for at least 5,000 years as medicine without any evidence of harm.
Furthermore. ethical approval and funding are difficult largely due to the evidence-free scaremongering about cannabis and the consequential stigma, in which the Home Office plays a leading role. Ethical approval and funding do not seem to be a problem in researching potential harms of cannabis. Indeed, as noted above, there is a massive amount of such research even though much of it is repetitive and inconclusive.
Until it is recognised that for many years, under successive governments, the Home Office has been systematically misleading and scaremongering about cannabis, it is difficult to see how an evidence-based decision can be reached. The Home Office regularly makes assertions about cannabis that are completely without evidential support. There is an established prejudice and determination to misinform and this must be tackled at root as it amounts to misconduct and corruption.
Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
There is a vast amount of peer-reviewed, published evidence of the safety and efficacy of cannabis as medicine. Much of this arises from research carried out in the USA, the Netherlands and Israel, where medicinal cannabis regulation has been in place for many years.
It is a populist myth, promoted by the Home Office, the press, the BBC and the prohibitionist lobby, that there is no evidence supporting the use of cannabis as medicine.
In February 2015, a delegation of medicinal cannabis users from CLEAR met with George Freeman MP, the life sciences minister, at the Department of Health who is largely responsible for medicines regulation. At the conclusion of the meeting, Mr Freeman requested CLEAR to produce a summary of the available evidence.
The result is the paper ‘Medicinal Cannabis:The Evidence’16 (MCTE) which has received international acclaim, so much so that in association with Centro de Investigaciones del Cannabis (CIC), a Colombian non profit association, a Spanish language version has been published.
MCTE was submitted to George Freeman MP in April 2015. Since then he has repeatedly refused to meet CLEAR again or respond to us directly, even after multiple requests from individual MPs representing CLEAR members. His only responses, received through third parties, fail to address the evidence at all. He simply refers to the legal status of cannabis, the theoretical availability of Sativex and the MHRA process for issuing marketing authorisations in respect of medicines.
This refusal to engage, acknowledge or properly consider the very large amount of evidence that is available is indicative of an inexplicable prejudice within government. Although conspiracy theories abound, it is difficult to understand why ministers adopt this position.
Cannabis was one of the most used medicines in the British pharmacopeia until only about 100 years ago. It could be restored immediately by a stroke of the Home Secretary’s pen to remove it from schedule 1. This would immediately make it possible for doctors to prescribe medicinal cannabis from Bedrocan17, the Netherlands government’s exclusive contractor.
Bedrocan cannabis is carefully regulated by the Netherlands government’s Office of Medicinal Cannabis. It is available in five different THC:CBD ratios. It is already exported to many countries in Europe and the company has established itself in Canada as well. It is less than a tenth the cost of Sativex for equivalent cannabinoid content and can be consumed either by a medical vapouriser or as an infusion.
No minister in this or any previous government has ever presented a coherent reason for the refusal to allow cannabis to be used as a medicine. Their only response is to fall back on largely spurious or exaggerated claims about the harms of recreational use.
What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
Cannabis would not need to be ‘licenced’ for medicinal use following a change in schedule. As soon as it removed from schedule 1, doctors would be able to prescribe it and businesses interested to grow, process and develop cannabis medicines would be able to obtain cultivation/possession licences from the Home Office.
Medicines are no longer ‘licenced’ in the UK. The MHRA grants marketing authorisations. The initial fee, simply for filling in the application form is £103,000.00, thus prohibiting any but the very largest, established businesses from even considering such a venture. The very term ‘marketing authorisation’ reveals the mindset of medicines regulators which is now more about commercial interests than the evaluation of the safety and efficacy of medicines.
The MHRA does have a regulatory scheme for ‘Traditional Herbal Registration’ (THR) but it only applies “if the medicine is used for minor health conditions where medical supervision is not required.”. An application for a THR for cannabis could not be made while it remains in schedule 1 but, if granted, would not permit its use for many conditions where there is excellent evidence of its efficacy.
The MHRA is locked in an inflexible, unscientific and restrictive process which can only evaluate medicines which are either one or two molecules. Its process is designed for synthetic, potentially very dangerous molecules and is entirely unsuitable for a plant based medicine such as cannabis. This is why, as explained above, Sativex has been improperly regulated as containing only two molecules: THC and CBD.
When the Sativex (nabiximols) patent expires, independent analysis of the medicine would certainly demonstrate that it is whole plant cannabis oil. Presumably alternative and/or generic versions could then be produced. However, by any standards, for all parties, the regulation and scheduling of Sativex is inaccurate, if not dishonest, and needs revision.
If cannabis is removed from schedule 1, most appropriately to schedule 4 alongside Sativex, in our judgement there will be a large number of businesses applying for cultivation/possession licences for research which will eventually result in applications for marketing authorisations. In the meantime, it can only be described as cruel and evidence-free not to permit doctors to prescribe Bedrocan, a safe, effective medicine already regulated by another European government.
It is likely that enabling the prescription of Bedrocan would result in substantial savings to the NHS medicines budget. However, any idea that this could be quantified based on existing evidence is fanciful. Certainly, compared to existing prescription medicines and Sativex, Bedrocan is very inexpensive, probably less than 10 euros per patient per day. However, the complexity of calculating which medicines it could replace by individual, partly or wholly and for how long makes the exercise so hypothetical as to be meaningless.
It must be true that once local, UK-based cultivation of medicinal cannabis was permitted, prices would reduce even further.
What role could EU regulations play in developing the potential for the medicinal use of cannabis?
Aside from France and Ireland (which is moving rapidly towards drugs policy reform), every other EU country has a more intelligent, compassionate and evidence-based policy towards medicinal cannabis. Based on existing policy and its record, the UK government would simply refuse to comply with any EU regulation of medicinal cannabis.
Under the Schengen Acquis (of which UK is a signatory, though not to the full Schengen Agreement), if a medicine is prescribed to a resident of a member state, that resident may travel to other member states with up to three month’s supply under the protection of a Schengen certificate. The effect of this is that a resident of the Netherlands, Belgium, Finland, Germany, Italy, etc. can bring prescribed cannabis, likely Bedrocan, into the UK and use it without restriction.
The crucial test here is residency, so it is not possible for a UK resident to travel to another country, obtain a prescription and then return to the UK legally with cannabis. Presently, a Schengen certificate for a UK resident has to be issued by the Home Office. Strangely and in contravention of this explicit provision, Norway (Non EU but a signatory to Schengen) does permit its residents to obtain prescriptions, usually in the Netherlands, and return home with cannabis.
It is also likely that given the hostility towards EU regulation, adding cannabis into that debate would be counterproductive. It would be used as another stick with which to beat the EU.
Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
As some members of the APPG are aware, CLEAR has been involved in trying to obtain legal access to prescribed Bedrocan since 2012. We now have approximately a dozen members who regularly receive private prescriptions from their doctors (both consultants and GPs) and travel to the Netherlands to have them dispensed.
In all instances, these individuals have either declared their medicine at customs and/or have made prior arrangements with the Border Force, producing supporting documentation.
This is possible because of errors and inconsistencies in the MoDA and the MoDR. All English drugs legislation, including the recent Psychoactive Substances Act 2016, is badly drafted, contradictory and scientifically illiterate.
The principle active ingredients of cannabis are delta-9-THC and cannabidiol (CBD). Bedrocan products are specified with different ratios of these substances. While cannabis is classified in schedule 1, so is delta-9-THC but it is also in schedule 2 described as dronabinol, which is the international non-proprietary name (INN) for delta-9-THC. CBD is not a controlled drug.
Therefore, if a doctor is prepared to write a prescription e.g. dronabinol (Bedrocan 22%) or dronabinol (Bediol 7.5%), three month’s supply of the medicine may be legitimately imported as a schedule 2 drug.
In the past four years only one CLEAR member has been frustrated in this. He had his medicine seized but he was not prosecuted. An appeal against the seizure failed.
Clearly, the vital factor in this scheme is a doctor who understands the law and the science and is prepared to write the prescription.
References
1. Misuse of Drugs Regulations 2001 http://www.legislation.gov.uk/uksi/2001/3998/contents/made
2. Misuse of Drugs Act 1971 http://www.legislation.gov.uk/ukpga/1971/38/contents
3. House of Lords Science and Technology Committee report 1998 http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm
4. Misuse of Drugs (Designation) Order 2001 http://www.legislation.gov.uk/uksi/2001/3997/made
5. Nabiximols (Sativex) https://en.wikipedia.org/wiki/Nabiximols
6. Cambridge News, 24th Jan 2012 http://www.cambridge-news.co.uk/Cannabis-company-enjoys-major-growth/story-22509041-detail/story.html
7. Email corres with Marc Rogerson, GW Pharma, 160312. Attached.
8. Sativex (nabiximols) marketing authorisation, MHRA , 2010 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf
9. Taxing the UK Cannabis Market, IDMU, 2011 http://clear-uk.org/media/uploads/2011/09/TaxUKCan.pdf
10. CLEAR Medicinal Users Panel http://clear-uk.org/pages/medicinal-panel/
11. GW Pharmaceuticals website http://www.gwpharm.com/
12. CUPID study, University of Plymouth, 2015 http://www.ncbi.nlm.nih.gov/pubmed/25676540
13. Institute of Psychiatry at King’s College London website http://www.kcl.ac.uk/ioppn/index.aspx
14. King’s College Confirms Institute of Psychiatry Misled Media On Cannabis Brain Study. CLEAR, 2015 http://clear-uk.org/kings-college-confirms-institute-of-psychiatry-misled-media-on-cannabis-brain-study/
15. Controlled Drugs (Supervision of management and use) Regulations 2013, Dept of Health https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf
16. Medicinal Cannabis: the Evidence, CLEAR, 2015 http://clear-uk.org/static/media/PDFs/medicinal_cannabis_the_evidence.pdf Attached
17. Bedrocan BV website http://www.bedrocan.nl/
Chip Somers, Drug Therapist Charlatan. Ignorant? A Liar? Or Both?
It takes a lot to get me angry these days about attitudes towards cannabis. Many people are simply misinformed and are themselves victims of a relentless propaganda campaign by governments and the gutter press. Today though I watched the Victoria Derbyshire show on catch up from last Tuesday, the day that Parliament published published its report on medicinal cannabis. In the studio were CLEAR member Lara Smith, UPA member Faye Adams and Chip Somers, described as a ‘government advisor’, was on Skype from his home in Hampstead.
You can watch the programme on BBC iPlayer here. The segment runs from 1:22:09 to 1:33.58.
Now this is the BBC, which is always pro status quo and has a dreadful record on inaccurate reporting about cannabis. It’s also the Victoria Derbyshire show, which is a long way from serious news and is more like a cross between Jeremy Kyle and Woman’s Hour – but give them credit for covering the issue
You can’t blame people who have been misinformed and whose prejudice is deeply ingrained from years of brainwashing. This applies to many MPs, journalists, even doctors and scientists. Remember, the endocannabinoid system. one of the most important physiological systems, isn’t even taught in UK medical schools, so ignorance is widespread, even amongst those you would expect to be well informed.
Chip Somers
There can be no excuse for this mendacious and wicked man, Chip Somers, though. He is, you will remember, the addiction therapist who grandstanded over his work with Russell Brand a couple of years ago. He advocates the total abstinence route to recovery which has been so eagerly embraced by the judgmental puritans at the Home Office and has led directly to the highest ever rate of drug overdose deaths, only released last week. Is the man simply a complete fool or is he deliberately dishonest? I think it has to be both. No one with the experience he claims could be so stupid. For some reason: misplaced morality, corrupt influence of money, government pressure, self-promotion of his therapy business – he is engaged in deception.
I’m not going to analyse every one of his miserable words. Watch him for yourself but prepare to be appalled. Suffice to say that his only tactic was to argue against medicinal use with ‘dangers’ that apply only to recreational use by children – a transparent disinformation strategy. He was also nothing less than abusive to Faye’s and Lara’s testimony and his dismissal of Professor Mike Barnes’ evidence review, which analyses 20,000 scientific papers, was just laughable.
Chip Somers is a liar, a charlatan, a confidence trickster and a deceiver. If only some such donkey of a faux therapist would seek recourse in the courts for such descriptions of him. Then we would have the opportunity to prove that he is a man of bad character and evil motivation.
Senior Conservative MP, Crispin Blunt, Joins CLEAR Cannabis Law Reform.
Crispin Blunt, Conservative MP for Reigate, has joined the advisory board of CLEAR Cannabis Law Reform as political advisor.
CLEAR is the largest drug policy reform group in the UK with more than 685,000 registered supporters. It was formed in 1999 and its main aim is to “To promote as a matter of urgency and compassion the prescription of medicinal cannabis by doctors.”.
Crispin Blunt is a graduate in politics from the University of Durham and an ex-Army officer. He has represented the constituency of Reigate, Surrey as a Conservative MP since 1997. He is presently chair of the foreign affairs select committee.
He commented on his appointment:
“I am pleased to join the board of CLEAR. It is wrong that people with a range of conditions are missing out from medicinal benefits of cannabis because of the UK’s out-of-date drug laws. We need a new approach and a sensible regulatory system to support patients and their healthcare professionals in accessing safe and effective medicinal cannabis products.”
Mr Blunt’s appointment comes a few days in advance of the publication of a Parliamentary report on medicinal cannabis. It is to be announced in the House of Lords, committee room 2 at 11.00am on Tuesday 13th September 2016. Alongside the report, Professor Mike Barnes, the world-renowned neurologist, who is also a member of the CLEAR advisory board, will be publishing a comprehensive review of the evidence of the medicinal applications of cannabis.
Peter Reynolds, president of CLEAR, said:
“This is what we need, a forward-thinking, Conservative MP, Crispin Blunt, alongside an eminent scientist and clinician, Professor Mike Barnes. Very shortly, we will also be appointing a human rights barrister to our advisory board. We aim to shake up the cruel, anti-evidence policy that denies British people access to cannabis as medicine. The UK is in the dark ages on this compared to most of Europe, the USA, Canada, Israel and Australia.”
CLEAR Member Lara Smith To Be ‘Star Patient’ In Parliamentary Report On Medicinal Cannabis.
Vicky Hodgson, Norman Baker, Lara Smith, Peter Reynolds, Nick Ellis. CLEAR meeting at Home Office, July 2014.
The launch of the APPG report on its inquiry into medicinal cannabis is a public event which anyone can attend. It takes place at the House of Lords committee room 2 on 13th September 2016 at 11.00am.
Baroness Molly Meacher and Caroline Lucas MP, are co-chairs of the APPG. The guest speakers will be:
Frank Field MP
Ron Hogg, Police and Crime Commissioner for County Durham
Professor Mike Barnes, Neurologist, CLEAR Scientific and Medical Advisor
Lara Smith, Medicinal Cannabis Patient, Life Fellow of CLEAR
Lara Smith
Lara was awarded a Life Fellowship of CLEAR in August 2014 in recognition of her enormous contribution to our campaign. She suffers from a terrible chronic pain condition which is only relieved by cannabis. Her consultant is one of those few courageous doctors in the UK who have supported their patient by prescribing access to Bedrocan medicinal cannabis products. Using the protocol which CLEAR pioneered, which exploits loopholes in the Misuse of Drugs Act 1971, Lara now gains legal access to Bedrocan products on a regular basis. She has to travel to the Netherlands in person to collect her medicine every three months and it has to be paid for on a private basis. The important thing is she gets the medicine she needs and she is within the law.
Home Secretary Invites CLEAR To ‘Enter A Dialogue’ On Cannabis Law Reform.
Rt. Hon. Amber Rudd MP, Secretary of State for the Home Department
In a letter dated 15th August 2016, Amber Rudd, the new Home Secretary, has invited CLEAR to raise “any queries and concerns” about present UK policy on cannabis. This is the first time since 2006, with Charles Clarke, that the UK cannabis campaign has had any direct contact with a serving Home Secretary. It reflects the reality, now recognised in government, that changes in cannabis policy are imminent.
In recent months, there has been a manifest and significant change in attitudes within the Home Office. We have seen this through the process of obtaining a low THC cultivation licence for our partnership with GroGlo Research and Development. The response from the drugs licensing department has been enthusiastic. There has been no difficulty with our declared purpose of producing CBD oil for sale as a food supplement and we are now in detailed discussions on our application for a high THC licence, looking towards clinical trials for a medical product for chronic pain.
As soon as Theresa May announced that Amber Rudd would be heading up the Home Office, I contacted my MP, now Sir Oliver Letwin, thanks to Cameron’s resignation honours list. Although he will not openly support our campaign, in the past year or so he has been very helpful indeed, meeting with me on roughly a monthly basis and helping me navigate through the Conservative government. He has now put me in direct contact with Ms Rudd and I will be preparing a written submission as a preliminary to a face-to-face meeting.
In accordance with CLEAR policy, our first concern is how we can enable UK residents to gain access to medicinal cannabis on a doctor’s prescription. In practice that means Bedrocan products as there is presently no other source of prescribable, consistent, high-quality, herbal cannabis. I would expect that to change very soon though. Both Canada and Israel look like potential near-future sources. GW Pharmaceuticals is undoubtedly considering entering the market and our venture with GroGlo could shift gear depending on how quickly UK policy changes.
We will also be addressing the need for wider reform and a legally regulated market for adult consumers. Although medicinal access remains the top priority, there is no doubt that more overall harm is caused by prohibition of the recreational market. It is this that creates the £6 billon per annum criminal market which is the cause of all the social harms around cannabis. This will need to be handled much more carefully as, due to nearly a century of misinformation and media scaremongering, many people still retain great fear as to what legal cannabis will mean.
The one thing that has been very lacking in the cannabis campaign is pragmatism. Most campaigners for recreational use continue to be lost in a swirl of ‘free the weed’, teenage angst, outrage, revolution and delight in being a rebellious outlaw. That was until 2011 when CLEAR introduced a new approach which has led to more engagement with government than ever before. The emergence of the United Patients Alliance and now the End Our Pain campaign has helped this but these campaigns are focused only on medicinal use
The fact is that we need to work with Theresa May’s government and the anti-Tory tribalism that many still adopt is nothing but an obstacle to reform.
In addressing Ms Rudd, our overall strategy for wider reform will be:
1. A final separation from the ridiculous ‘free the weed’ movement and ‘stoner’ groups which are incapable of understanding how they are seen and despised by wider society.
2. Differentiation between medicinal use and the more controversial legalisation for adult, recreational use.
3. Shift public attention onto scientific and medical evidence rather than the very poor standard of media reporting.
4. End the fake policy that says ‘cannabis is dangerous therefore it must be regulated’. Educate that nearly all the harms around cannabis are caused by its prohibition, not by cannabis itself.
5. Emphasise the importance of harm reduction information, education about excessive use and essential investment in treatment for those who do suffer health harms.
6. Clarify that decriminalisation is no solution and is a dangerous option that would probably increase harm. The product needs to be sold within a properly regulated environment, careful that over-regulation would support a continuing criminal market.
Oh No! Do We Really Want Jeremy Corbyn Supporting Medicinal Cannabis?
It’s a bit like when Russell Brand came out in favour. He’s right, just as Corbyn is but it doesn’t do us any good. It just gives our opponents ammunition to portray the campaign as the preserve of losers and eccentrics.
I quite like Jeremy Corbyn, even if many of his policies are, in my opinion, bonkers. I certainly think he’s a very healthy influence on British politics but his support is not going to help us gain legal access to medicinal cannabis. If anything it’ll get in the way. With at least 10 years of Tory government in front of us, probably 20, allying ourselves with Corbyn is going to alienate those whose minds we need to change.
Eccentrics, Please Do Not Apply.
Again, like Russell Brand, whose intellect is beyond doubt, so is Corbyn’s sincerity – although his statements on wider drugs policy at last night’s leadership hustings are as confused as any politician on the illiberal wing of the Conservative Party or the authoritarian wing of Labour. It seems Mr Corbyn is just as much in favour of prohibition and supporting criminal drugs markets as any alcohol-sponsored Tory MP.
It’s not Jeremy Corbyn we want onside. It’s politicians that now or in the future will hold the reins of power. I admire the way he has seen off the despicable rump of New Labour, Blairite ponces. Their spiritual leader, Peter Mandelson, and his up and coming disciples like Chuka Umunna are the last people we want anywhere near government. The record of science-deniers like Jack Straw, Jacqui Smith and Alan Johnson is best forgotten. If Corbyn can keep that nasty bunch occupied and distracted he will deserve huge credit. I wouldn’t quite, yet, place him in the same category as Tony Benn, a man who I disagreed with profoundly yet respected enormously but he’s cast from the same mould. He is a man of integrity but sadly, not a man cut out for success in terms of gaining political power.
If I’m wrong about Corbyn and his support does positively influence the campaign for medicinal cannabis, I’ll gladly eat my hat – or present Match of the Day in my underpants or whatever forfeit is deemed appropriate. In the meantime though, CLEAR will continue to focus on and work with politicians who can actually make a difference.
May Brings A Fresh Start To The Cannabis Campaign.
Would that we were in spring looking forward to a splendid summer. Instead, in mid-July we are heading into autumn towards what looks like a stern, drab and ominous future. Theresa May is prime minister, perhaps the worst nightmare for those who seek cannabis law reform.
You have to admire her first few days though. What you see is what you get. She is smart, calculated and very, very certain about the nature of the government she will lead. I have no doubt she has a softer, caring side and there is testimony to that effect from those who support her. She is a strong woman, she will be sympathetic to people and causes that she chooses but ruthless and absolute against those she opposes. Our problem is that, as confirmed by both the National Audit Office and Public Accounts Committee, evidence has nothing to do with it. Theresa May’s drugs policy is based on her personal opinions and even the plight of those in chronic pain and disability is unlikely to change her mind even on the medicinal use of cannabis. I remember Norman Baker told me that she simply does not comprehend that cannabis can be a legitimate medicine. The very idea is anathema to her. It is beyond her comprehension. The daughter of a vicar, who attended a convent then a grammar school, she has a lot about her that suggests piety, reserve, self-discipline and control. Admirable qualities but lacking perhaps in empathy with modern lifestyles and values.
Amber Rudd MP, Home Secretary
But this is a fresh start. Amber Rudd, the new Home Secretary, is cast from the same mould as Ms May. My MP, Oliver Letwin, himself disposed of in the new cabinet, has already written to Ms Rudd and asked her to see me. As of today, CLEAR represents nearly 700,000 registered supporters, equivalent to the electorate in more than eight parliamentary constituencies, so I think she has a good reason to give me a few minutes. I will continue to press for a meeting until she or one of her junior ministers agrees to see me.
It can only help that I am now a fully paid-up member of the Conservative Party. I made this decision shortly after the EU referendum and I have also joined the Conservative Policy Forum which works to influence Conservative Party policy from the grassroots. I will be advancing the cause of medicinal cannabis and wider drugs policy reform as quickly and effectively as I can through the party’s established channels. Whether it is a short or long game, it has to get started now.
I do believe this is the best way forward for the cannabis campaign. I will work from within the party of government to try and influence change. It is more than likely that the Tories will be in power for the next 10 years, if not more. Now is the time to get involved, face our opposition, engage with those who have power. Every other UK political party is in disarray.
When we relaunched the Legalise Cannabis Alliance as CLEAR Cannabis Law Reform in 2011, we brought a totally new, professional approach to the campaign. Others have followed and there is now a significant group that understands how to use professional lobbying techniques. The greatest achievement of this has been to get the Liberal Democrats involved and although there remains great resistance amongst party members in the shires, the leadership is very much onside. Sadly, the party itself is as far away from power as it has ever been and, in my view, has swung widely off course in a futile and misguided effort to reverse the referendum result. Such whimsical strategies have always been the LibDems’ problem. Unless a political revolution suddenly makes Corbyn a serious contender then there will be no other party in power but the Tories. This is where we must invest time, effort and all our resources. We must understand how to turn Tory aims, ambitions and viewpoints to our advantage. Which arguments will work and how do we get them across?
Although we now have a more professional campaign and several individuals with real ability, now is not the time to revert to talking amongst ourselves. Conferences, meetings, documentary films and events are all very well but they almost exclusively preach to the choir. Just like the demos and protests that have at last ebbed away, they make those involved feel good and they ramp up morale but they do little to create change. This is no way to make progress. I will ensure that CLEAR is on the front line. It is those who oppose us that we need to be talking to, not those who already agree with us.
Professor Mike Barnes
At the same time, specifically on medicinal cannabis, our focus must be on the medical profession. We published ‘Medicinal Cannabis:The Evidence’ just over a year ago and it has added real credibility to the campaign. In a few weeks when the APPG for Drug Policy Reform publishes its report on medicinal cannabis, Professor Mike Barnes will release his own review of current evidence and it will become the definitive work on the subject. CLEAR will be taking this to GPs all over the country, to the Royal Colleges and particularly to those working in pain management. We already know that thousands of doctors endorse their patients’ use of cannabis for chronic pain, it is time to bring this out of the closet. Doctors and nurses have literally been terrorised into keeping quiet about cannabis. We have first hand knowledge of Home Office officials warning off doctors who have tried to assist their patients by prescribing Sativex off label or recommending Bedrocan. This must stop. We must equip the medical profession with the evidence it needs to be able to do the best by its patients.
I know many will be downhearted by this new government but change is always a good thing. It offers us the opportunity to renew our campaign. Most important, we must walk towards the enemy, not hide in our bunkers, fearful of their response. All over the world, mainstream opinion is turning in favour of cannabis as medicine and wider drugs policy reform. Now is the time to step forward, to do all we can to educate and inform those who are still in the dark. I have set out above what CLEAR’s new strategy will be. Please join us. Become a member. Sign up here. Your first duty? Make an appointment to see your MP. This is the most effective thing you can do. We will publish new guidance in the next few days on how to prepare for and conduct these meetings.
Why I Have Joined The Conservative Party.
I would vote against Theresa May. She would be a disaster for Britain and for the Tory Party. Sadly, I will not have been a member long enough to vote in the leadership election.
Now, more than ever, we need to walk towards the enemy, not run away. The entrenched, bigoted, old-fashioned, anti-evidence faction of the Conservative Party, of which Theresa May is part, is the enemy of Britain and the enemy of a progressive, enlightened society. I will work from within the Tory Party to campaign for more rational, reasonable and responsible policies. We need to tackle the future head on and only from within the Conservative Party is there any realistic possibility of having meaningful influence.
I resigned from the Liberal Democrats shortly before the EU referendum because I believe its support for the remain campaign was a betrayal of fundamental values of liberalism and democracy. Support for the unelected, unaccountable oligarchs of the EU is the nemesis of the Liberal Democrats and Tim Farron’s subsequent hate speech, branding all who voted leave as ‘intolerant, closed-hearted, pessimistic and inward looking’ has moved his party’s talent beyond self-harm to political suicide.
Clearly, in my special interest area of drugs policy and particularly medicinal cannabis, the Conservatives, and particularly Ms May, have not been our allies. Yet another reason why I, and others, must now grit our teeth and get involved with the Tories. We will make no progress unless we do. We have to appeal to the libertarians, to those who value personal liberty and who believe in evidence-based policy, not prejudice.
The response of both remainers and the left to the Brexit vote has been appalling. Aside from Tim Farron’s conduct, the chattering classes, particularly the soft left which dominates the drugs policy debate, has been defeatist, bitter and negative. It will spend its time, as it always does, in endless circular discussions talking amongst itself, the same old faces, the same old ideas. Someone needs to take the fight to where the real battle is.
I recognise that my decision to join the Tories will be difficult for many to understand. It will not be an easy path but the drugs policy and cannabis campaign needs someone to lead it into battle, to take on the establishment, to engage with and change minds.
The Labour Party is unelectable and if it survives at all, it will never see power again for many years. All other parties are irrelevant. There is no other route to power in the UK except through the Conservative Party.
CLEAR and GroGlo Establish First UK Clinical Trials on Cannabis for Chronic Pain.
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
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
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
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.
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.
The most authoritative, independent, expert research on the UK cannabis market by the Independent Drug Monitoring Unit, commissioned by CLEAR in 2011.
How 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
Medicinal 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.
Peter Reynolds 