Posts Tagged ‘Sativex’
NICE Rejects Professor Mike Barnes’ Expertise in Cannabis as Medicine for a Second Time
Professor Mike Barnes is without doubt the UK clinician with the most expertise in the use of cannabis as medicine. He should have been first choice as a member of the NICE committee charged with developing cannabis prescribing guidelines and, as reported here, its rejection of his application was greeted with astonishment. However, NICE relented and invited Professor Barnes to an interview. Now they have rejected him again.
Mike was responsible for obtaining the first medicinal cannabis licences for Sophia Gibson and Alfie Dingley and he has been involved in countless behind-the-scenes efforts to assist others. He joined the advisory board of CLEAR in July 2016, is an ambassador for the End Our Pain campaign and has since contributed his expertise to several other organisations including UPA. He is also founder and director of education at the Academy of Medical Cannabis and founder of the Medical Cannabis Clinicians Society.
What concerned NICE in the first place was that in February 2018, Professor Barnes was appointed Chief Medical Officer of SOL Global Investments (known as Scythian Biosciences until June 2018). NICE was concerned this could be a conflict of interest. In fact, SOL is an international cannabis company with a focus on legal U.S. states. It has no investments or plans for the UK. When Mike told NICE this he was invited for an interview. The second letter of rejection reads:
“It was clear that you have relevant experience and expertise in this area however the interview panel remained concerned about possible conflicts of interest around your links to commercial organisations and your campaign work in the area which means that you have a publicly stated position on the topic.”
Few will regard that as a credible or logical reason for not having Mike on the committee. It’s actually absurd and really makes one wonder who makes these decisions and what planet they are on. If there were even a few alternative candidates to consider then it might make some sense but there don’t appear to be any alternatives to Mike Barnes. If there is anyone else in the UK with his clinical qualifications, knowledge, experience and expertise, no one at CLEAR has heard of them. It’s foolish and irresponsible to reject the only real source of knowledge that will command respect from other clinicians and for such very flimsy and poorly thought through reasons.
How many other clinicians on other NICE committees have commercial relationships with pharmaceutical companies or other medical organisations? How many have also expressed their professional or personal opinions on matters of medical policy and practice? Have they been disqualified for the cardinal sin of holding an opinion? Does NICE want people on this committee who are insufficiently informed or so shy that they do not express opinions?
Could this happen anywhere but in Britain? However patriotic and loyal one is to our country, this sort of crass stupidity and hypocrisy seems to be a special gift of the UK civil service.
NICE has Form for this Sort of Self-Defeating Bureaucracy
Its ‘Do Not Do Recommendation’ on Sativex is directly relevant and is based on on a flawed assessment of cost effectiveness which itself is founded on ignorance of the way cannabis works and a determination not to give proper weight to MS patient reports of the benefit they gain from Sativex. None of this is to overlook the unethical and profiteering price which GW Pharmaceuticals wants to charge for the medicine. Pharmacologically identical products are available from US and Canadian medical cannabis dispensaries for about one-tenth the price of Sativex.
NICE has also failed dismally on the Freestyle Libre glucose monitoring system for diabetics. This revolutionary new system not only makes life much easier for thousands of people, doing away with the need for endless finger pricking, it also dramatically improves blood sugar control promising huge reductions in the long term cost of diabetes to the NHS. It’s been available since 2014 and thankfully will now be prescribed on the NHS from April 2019 but for five years NICE has dithered, waffled and procrastinated on it, exactly as it is now doing with cannabis. Until now, just as with cannabis, it has claimed insufficient evidence but the real problem is NICE has a blinkered view and fails to look widely enough for the evidence it requires.
In a remarkable parallel with the way it is handling cannabis, NICE claimed there was no evidence that the Freestyle Libre led to better blood sugar control in type 1 diabetics, But the reason it claimed this was that there was no study supporting it that met NICE’s criteria and by impeding uptake of the device it was making such a study virtually impossible. NICE totally failed to give any weight to the many case reports of really dramatic benefits – exactly as it is doing with cannabis.
So, while our prime minister and the Home Office drugs minister have a direct financial interest in the UK’s only commercial producer of medicinal cannabis, yet direct and control drugs policy, when it comes to caring for patients, the only British clinician with relevant expertise is disqualified by a connection with an overseas cannabis company and for expressing an opinion than cannabis could help many people.
As a footnote, I should declare that I also volunteered to give my time to the NICE committee as a lay member and I too was rejected. It’s not for me to question its judgement unless I have good reason to but given its track record with Mike Barnes, I do have legitmate concerns. I first gave expert evidence to Parliament on the subject in 1983 and again in 2012 and 2016. Since 2011 I have worked intensively with hundreds of people who use cannabis as medicine and I lead the group that represents more such people than all other UK groups combined. I am also the author of the study Medicinal Cannabis: The Evidence, which has been translated into three languages and has been cited many times throughout the world. I know of no one in the UK with more relevant experience than me.
The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.
Bedrocan, the Netherlands government’s official producer, grows cannabis in which the cannabinoid and terpene content is standardised and consistent. It does this by very careful cultivation techniques which include clonal propagation, continuous analysis and gamma irradiation to eliminate contamination with potentially harmful microbes. Its production facility is Good Manufacturing Practice (GMP) certified.
With the exception of Sativex, which NICE has declared as not cost effective, the Bedrocan range offers the only medicinal cannabis products which could be readily available in the UK. They are also available as oils extracted directly from the raw herbal flowers.
It’s very simple, unless Bedrocan products come within the definition of a ‘cannabis-derived medicinal product’, the very welcome reform announced today by Sajid Javid will fail and most people will have no option but to continue sourcing their medicine from the illegal market.
There is no doubt that the gold standard in safety, efficacy and self-titration is vaporised herbal cannabis of Bedrocan-standard quality. Cannabis that is ingested as oil, either sub-lingually or through the gastrointestinal system, has a substantially different pharmacology and is very difficult to titrate accurately or to deliver its beneficial effects promptly.
Bedrocan provides an immediate solution. GW Pharmaceuticals could also easily turn to providing a similar range of products. One hopes that it could also be prevailed upon to reconsider its pricing of Sativex. It is essential however that new, domestic production facilities are established quickly. Up to now the Home Office has rejected all efforts to set up such facilities, even applications from extremely reputable international businesses that already have licences elsewhere. This policy must be immediately revised.
Dame Sally Davies advised that “only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios”. The ACMD agreed with this, stating that “raw cannabis (including cannabis-based preparations) of unknown composition should not be given the status of medication.” Bedrocan products fully comply with these requirements and it is essential that they are re-scheduled and made available on prescription.
Home Office Denies FOI Request In Cover-Up Of All Information On Cannabis Production Licences
On 6th March 2018 CLEAR submitted a Freedom of Information Request to the Home Office asking for full details of the licences accounting for the legal production of cannabis in the UK. This arose from the story which we broke on 4th March revealing that the UK is the world’s largest producer and exporter of legal cannabis, this according to data provided to the International Narcotics Control Board (INCB) by the government.
The Home Office has refused the request. Its grounds for refusal are that disclosure “would, or would be likely to, prejudice the commercial interests of any person or would be likely to prejudice the prevention or detection of crime“.
Presumably this means that the commercial interest of GW Pharmaceuticals and whoever else has been granted such licences would be prejudiced and that they would risk robbery or other crime at their places of business.
INCB Production of Cannabis 2015-2016
We consider this to be false and without any merit whatsoever. How would it prejudice anyone’s commercial interest? We would not expect any detail that goes behind the licence holder’s normal commercial confidence and it must be right that the identity of those companies or individuals licenced to produce cannabis should be on the public record together with outline information about the terms of the licence – what is it for, for what period, in what quantities. Furthermore, with the security precautions required for such a licence, any attempt at crime would be foolhardy and utterly stupid. It would be much easier either to import or produce your own cannabis. The sort of criminal enterprise that would be required to raid, for instance, one of GW’s grows would be on a grand scale, incredibly risky and with sentences probably higher than for production of cannabis.
Clearly, disclosure of the information around these licences could, in any case, be limited to redact any specific information which should be kept confidential
It’s quite clear that this refusal is simply an excuse, probably to cover-up not only the extent of the licences but also the basis on which they have been issued.
Of course, the Home Office has pre-empted the next step in a FOI request and states that “the public interest falls in favour” of not providing this information. We consider this to be nonsense. It is clear that the public interest (not just the interest of the public) is very much that the issue of such licences should be a matter of public record. It is outrageous that this information is being kept secret.
The answer to the second part of our FOI Request provides further insight into how little trust can be placed in the Home Office and demonstrates that its answers are dishonest. In answer to a written question in Parliament on 1st March 2018, Home Office minster Nick Hurd MP said “No licences for pharmaceutical companies to grow and process medicinal cannabis for exportation to other countries have been issued.” However the INCB report, which information can only have come from the Home Office, shows that in 2015/16 the UK exported 2.1 tons of medical cannabis. We asked for an explanation of how Mr Hurd’s answer is consistent with the facts reported.
Nick Hurd MP, Home Office Minister
The Home Office’s answer is that “these figures could include any plant material exported for pharmaceutical purposes or pharmaceutical products containing cannabinoids that are manufactured in the UK and exported, such as Sativex.” and that it takes ‘medicinal cannabis’ to mean “substances produced to be consumed, be that smoked or ingested in any way.”
It is clear therefore that the Home Office has given two different answers to the same question and that the answer given to the INCB is correct whereas the answer given by Mr Hurd is without doubt intended to mislead Parliament. It also seeks falsely to create a distinction between Sativex and other forms of cannabis which is manifestly and beyond doubt another deception, based on information published by GW Pharmaceuticals which CLEAR revealed in 2016.
In summary therefore, the Home Office has refused to answer the FOI Request in relation to licensing on grounds which are entirely spurious and has demonstrated that it is actively engaged in deceiving both Parliament and the public on the export of medicinal cannabis from the UK.
Following the required procedure, we have now requested an internal review of the Home Office’s handling of the FOI Request. We argue that: “It goes directly to the question of the massive public demand for legal access to cannabis for medical use and the total denial of this by government. This policy is itself irrational and against the public interest and the refusal to disclose the information requested is a political cover-up.”
We anticipate this will be a whitewash and further attempt at a cover-up. Thereafter we have a right to complain to the Infomation Commissioner. At this stage we would also seek to mobilise support from MPs with an interest in this area. Ultimately, we may be able to apply to the High Court for judical review of the Home Office’s decision and we will consider mounting a crowdfunding campaign to enable this.
This is Paul Kenward, husband of Victoria Atkins MP who is the UK drugs minister. He grows cannabis for a living.
Mr Kenward is managing director of British Sugar which grows cannabis under contract to GW Pharmaceuticals at its 45 acre greenhouse in Wissington, Norfolk. As confirmed by British Sugar, the cannabis is for production of Epidiolex, GW’s epilepsy medicine which is understood to be 98% cannabidiol (CBD).
British Sugar website
Epidiolex is not yet licensed as a medicine although it is currently with the FDA for US approval and the European Medicines Agency for approval within the EU including the UK. It’s unclear how the British Sugar operation can be legal as according to the Home Office it only issues licences for research purposes. Only after the medicine has received a marketing authorisation could it be legally grown for commercial purposes.
This is Mrs Kenward, who prefers to be known by her maiden name of Atkins, in a recorded discussion with Kevin Sabet, America’s most notorious anti-cannabis campaigner who is fighting desperately to see the wave of legalisation in the USA reversed.
Victoria Atkins MP is now a junior Home Office minister with responsibility for drugs policy. She has spoken out forcefully against any form of legalisation or regulation of cannabis in the UK. She also rigidly maintains the government’s line that there is ‘no therapeutic value’ in cannabis. Of course, when it comes to her husband she takes a different view and, of course, she has authority to see licences issued entirely on her own discretion.
Ms Atkins spoke about drugs regulation in Parliament in July 2017:
Isn’t it is her husband who is exactly the person she is talking about? He seems to be doing just fine as a “law-abiding citizen”.
Together with the Home Secretary, Amber Rudd MP, other cabinet minsters, including prime minister Theresa May, who was the previous Home Secretary, Ms Atkins is running a giant cannabis cartel. As shown by the International Narcotics Control Board, the UK is in fact the world’s largest producer, stockist and exporter of ‘legal’ medical cannabis.
UK citizens are denied any access to medical cannabis at all, except in the form of another licensed GW product known as Sativex. However, in practice, Sativex is virtually impossible to obtain. It is believed that about one million UK citizens use cannabis illegally for medical purposes.
No, this is not a spoof article. This story is so incredible and outrageous that you really couldn’t make it up. Yes, the picture of Paul Kenward is photoshopped but all these facts are easily verifiable.
Misleading Parliament Again. Victoria Atkins, The Drugs Minister With A Family Cannabis Farm.
She’s back! Victoria Atkins MP is again engaged in answering parliamentary questions on cannabis for the UK government. Clearly this is wholly improper when she directly benefits from commercial production of cannabis.
Ms Atkins disappeared from public view for a few weeks after CLEAR revealed that her husband is growing 45 acres of cannabis under government licence while she argues against drugs regulation in Parliament. It was particularly notable that she was absent from the House of Commons during the recent urgent question debate on a medical cannabis licence for Alfie Dingley. Instead, her colleague Nick Hurd MP, ostensibly the Police Minister, was required to answer a question on drugs. Similarly, she was nowhere to be seen as Paul Flynn MP’s bill came up for debate, which sadly, as CLEAR had predicted, never took place.
It is simply extraordinary that the so-called Drugs Minister should duck and dive out of view when such issues of massive public interest hit the headlines. She has a massive conflict of interest and it is completely unacceptable for her to continue in her present role.
Yesterday, 7th March 2018, she answered a written question from Roger Godsiff, the Labour MP for Birmingham Hall Green.
“To ask the Secretary of State for the Home Department, if she will assess the health and economic benefits of legalising cannabis for medical use.”
Ms Atkins answered:
“The World Health Organization’s Expert Committee on Drug Dependence has committed to reviewing the scheduling of cannabis under the United Nation’s 1961 Convention. This is due to consider the therapeutic use, as well as dependence and the potential to abuse constituent parts of cannabis. This is due in 2019 and we will await the outcome of this report before considering the next steps.”
This answer is at best disingenuous and misleading. Once the full facts are understood it is clear that it is deceptive and mendacious.
British Sugar’s giant greenhouse in Wissington, Norfolk where Victoria Atkins husband, Paul Kenward, grows cannabis
Ms Atkins husband, Paul Kenward, managing director of British Sugar, grows cannabis under contract to GW Pharmaceuticals for the production of medicine. Ms Atkins deceit is predicated on another deception promoted by the UK government that is some way or another, Sativex, GW’s cannabis medicine is not cannabis. GW is perfectly straightforward about this. Sativex is a whole plant cannabis extract adjusted by simple blending of two different strains to deliver 1:1 ratio of THC:CBD. It contains all the other cannabinoids, terpenes, flavonoids and other compounds present in the plants from which it is made. The government deception is to justify the issue of a marketing authorisation (MA) for Sativex by the Medicines and Healthcare products Regulatory Agency (MHRA) which is itself a deception. The MA was issued on the basis that Sativex is THC and CBD alone. The MHRA conveniently overlooks the hundreds of other ingredients and calls them “unspecified impurities”. The consequence of this is that, ludicrously, Sativex is a schedule 4 drug whilst any other form of cannabis remains schedule 1 and may not be prescribed
But the plot thickens. The deceit goes even deeper. It has been widely reported and British Sugar confirms that its grow is not for Sativex but for production of Epidiolex, the 98% cannabidiol (CBD) medicine that has not yet received an MA. If, as appears certain, this is the case then the British Sugar grow is unlawful under the declared policy of the government. Cannabis production licences (other than low-THC industrial hemp) can only be issued for “research or other special purposes“. They most certainly cannot be issued for the production of a medicine that is not yet authorised. Even if the British Sugar cannabis is low-THC, it is definitely not an approved EU industrial hemp strain and the purpose of its production is presently unlawful.
Ms Atkins through her husband is therefore engaged in the unlawful production of cannabis and is directly engaged in misleading Parliament as to government policy, the law and the medical value of cannabis. The World Health Organization story is a trick, a distraction, an excuse to divert Parliament from understanding the truth.
Ms Atkins conduct cannot be described in any other way except as corrupt. She is a disgrace as a minister of the Crown, to Parliament, to her profession as a barrister, to the Conservative Party, to her constituents in Louth and Horncastle and to the United Kingdom as a whole and all of its citizens. She is manifestly unfit for any public office.
The UK Is The World’s Largest Producer And Exporter Of Cannabis But Its Citizens Are Denied Any Access At All
This is the astonishing fact revealed by the International Narcotics Control Board (INCB) in its 2017 report on narcotic drugs.
In the UK no one has any legal access to any form of cannabis except exempt products derived from industrial hemp, most commonly CBD oil.
Theoretically, the cannabis medicine Sativex is available but in practice, in England it is virtually impossible to obtain it except on a private prescription as the National Institute for Health and Care Excellence (NICE) has recommended that it is not cost effective. In Wales it is available on prescription but doctors are first required to try highly toxic and dangerous drugs such as baclofen, tizanidine, gabapentin, pregabalin, even botulinum toxin or opioids.
The reality is that UK citizens are denied access even though their country is producing and exporting vastly more cannabis even than countries such as the USA, Canada, Israel, the Netherlands and Italy, all of which have legitimate and well regulated medical cannabis provision.
This revelation will further inflame the sense of righteous injustice in the UK. Against this background the UK continues to prohibit even medical use and is stubborn and intransigent in even being prepared to consider or discuss the evidence in favour.
How can the country which sanctions the legitimate production of more medical cannabis than any other in the world deny its own citizens legitimate access?
The UK Government’s Very Last Excuse For Denying Access To Medicinal Cannabis.
Essentially, UK government policy on cannabis hasn’t altered since 1971. Despite the vast amount of new evidence published since then and revolutionary change, particularly on medicinal use, all across the world, successive governments have stubbornly and obstinately refused to consider any sort of reform.
It doesn’t matter which party has been in power, Conservative, Labour or the coalition, it’s a subject that ministers and MPs simply refuse to engage with. It’s easier that way for them and be in no doubt: laziness, fear of a media backlash and deeply ingrained prejudice are the key factors in this impasse.
Grubby, Corrupt Deal Between Brown And Dacre
We had the downgrade to class C in 2003 and then back up to B in 2009 but this was a turgid and useless effort. No notice was taken of any evidence arising from this experiment. It was enacted to enable police to concentrate more on class A drugs and reversed based on Gordon Brown’s ‘Presbyterian conscience’ and a grubby, corrupt deal with Paul Dacre to win the Daily Mail’s political support. In fact, use went down while cannabis was class C and back up again when it was upgraded but governments have no interest in facts or evidence on this subject, only in political expediency and spinning advantage with the media.
The clamour for medicinal access has increased enormously, just as the evidence for its safety and efficacy has become overwhelming. The UK is now virtually isolated amongst first world countries with a cruel, inhumane and anti-evidence policy which makes us a laughing stock with all who are properly informed. It’s not a laughing matter for the victims though. For those persecuted by this nasty policy it is tears, pain, suffering, disability – all of which could be alleviated to at least some extent just by a stroke of the Home Secretary’s pen. It is sickening that all those who have held that office over the last 45 years escape without any shame or opprobrium on their character.
Home Secretaries Have A Lot To Answer For
CLEAR receives hundreds of letters and emails every year from people who have written to their MP about medicinal cannabis and it is astonishing that unlike almost every other policy, exactly the same words are used by all MPs. They slavishly repeat the Home Office line which is ruthlessly enforced across party lines.
There have been some subtle changes. The marketing authorisation issued for Sativex in 2010 has led to a minor change in the tired and inaccurate line ‘there is no medicinal value in cannabis’. It’s now become ‘there is no medicinal value in raw cannabis’. This is scientifically and factually incorrect. Pharmacologically, Sativex and the ‘raw’ plants from which it is made are identical. It is whole plant cannabis oil and its authorisation by the MHRA as an extract of THC and CBD is fundamentally dishonest. GW Pharmaceuticals reveals it contains more than 400 molecules, the MHRA says it only contains two and “unspecified impurities”.
More recently, and in the face of an explosion of supportive evidence, another line has been added. This states that ‘the UK has a well established process for the approval of medicines through the MHRA and that any company wishing to bring a medicinal cannabis product to market should follow this procedure. In fact, inside sources suggest that the government is very keen to see new cannabis-based medicines approved by the MHRA. It would take the wind out of the sails of the medical cannabis campaign
This is the very last excuse for denying access to medicinal cannabis. It is nothing but an excuse and one that is misleading and based on deception. If we can expose how weak, inappropriate and fake it is, the government will have nowhere else to hide.
Firstly, as demonstrated with Sativex, the MHRA process is incapable of dealing with a medicine that contains hundreds of molecules. It is designed by the pharmaceutical industry for regulating single molecule medicines, usually synthesised in a lab, which have the potential to be highly toxic. CLEAR rejects the tired, boring theory that ‘Big Pharma’ is engaged in a massive conspiracy to deny access to cannabis and to ‘keep people ill’ so it can continue to sell its products to the NHS. The MHRA isn’t engaged in such malevolent conduct, it’s simply incapable of 
properly evaluating a whole plant extract through its existing methods.
The bright, shining truth of this, that totally demolishes the government’s position, is that in every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. Every other government that has recognised the enormous benefit that medicinal cannabis offers has come to the same conclusion: cannabis is a special case. It is far more complex but much, much safer than pharmaceutical products.
Of course, there is also the ludicrous status of cannabis as a schedule 1 drug, which prevents doctors from prescribing it. If it was moved to schedule 2, alongside heroin and cocaine, or to schedule 4 alongside Sativex (the logical choice), doctors could be prescribing it tomorrow and high-quality, GMP and EU regulated medicinal cannabis from Bedrocan would be immediately available.
So the MHRA is the final excuse, the last obstacle to a revolution in healthcare in the UK. We need an ‘Office of Medicinal Cannabis’ as there is in the Netherlands, or ‘Access to Cannabis for Medical Purposes Regulations’ as administered by Health Canada. Colorado has its ‘Medical Marijuana Registry Program’ and other US states have similar arrangements. Israel’s Ministry of Health has its ‘Medical Cannabis Unit’. In Australia, its equivalent of the MHRA, the Therapeutic Goods Administration, has established its own set of medical cannabis regulations.
This is now the most important factor in achieving medical cannabis law reform. Next time you contact your MP or in any advocacy or campaign work you do, this is where to focus your energy. Cannabis is a special case, it is not like other medicines. Once we can open the eyes to this truth the path ahead will be clear.
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/
Whose Money Is UCL Wasting On Pointless Cannabis Research?
The Times reports “Stone me: cannabis users don’t like hard work”
The Independent says “Getting high on cannabis makes you less likely to work hard for money, study says”
The mendacious Daily Mail claims: “How just one cannabis joint harms your will to work: Fears long-term drug use could harm motivation even when not high”
Utterly pointless research. Such results can be determined by common sense and experience.
UCL has a habit of frittering money away on pointless research into cannabis.
First of all we had the reckless overdosing of Jon Snow for the Channel 4 Drugs Live programme, equivalent to asking a teetotaller to drink a bottle of scotch in 10 minutes – set up purely for sensationalism and tabloid headlines. Results? Cannabis was shown to be very safe for 95% of people – as if we didn’t know that already.
Currently Prof Val Curran is studying whether cannabis can be used to treat cannabis dependency. Yes, seriously, Sativex, the cannabis oil mouthspray, is being trialled to see if it can help people give up smoking cannabis!! Not that cannabis dependency is anything like a serious problem anyway. Fewer regular users of cannabis become dependent on it than regular users of coffee become dependent on caffeine. Incredibly the University of Sydney is also conducting an identical trial.
Now we have this absurd study on motivation. Why do people use cannabis? To relax of course, so hardly surprising they become less motivated, that is the point! And the study showed that motivation returns to normal levels after smoking! You really couldn’t make it up that so-called scientists waste their time on this sort of nonsense.
What we need is some constructive research on the therapeutic benefits of cannabis. In the 34 US states that permit medicinal use, expenditure on dangerous and addictive pharmaceutical painkillers has plummeted by hundreds of millions of dollars.
Now that would be something sensible to look into. But maybe it doesn’t suit the agenda of whoever provides UCL with money to conduct its frivolous and pointless studies?
Listen to me interviewed on Talk Radio about this latest study.
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.
Peter Reynolds 