Posts Tagged ‘CBD’
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/
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.
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.
A CLEAR Response To the Liberal Democrats’ Proposals For Cannabis Regulation.
CLEAR welcomes the Liberal Democrats’ proposals which can be seen here. We set out below a few comments which we intend to be constructive.
We represent more than 600,000 people who support cannabis law reform. Our own publication, ‘How to Regulate Cannabis in Britain’ is now in its second edition.
It is based on independent, expert research which we commissioned from the Independent Drug Monitoring Unit, published as ‘Taxing the UK Cannabis Market’.
Comments on ‘A framework for a regulated market for cannabis in the UK’
1. We support a cautious approach and agree that it is better to start with stricter regulation that could, based on experience, be relaxed at a later date if appropriate.
Spectrum of Cannabis Policy
We reject the diagram ‘Exploring a spectrum of options for regulating cannabis’ which paints an inaccurate picture of the effects of a legal market. Evidence from all jurisdictions that have implemented reform does not support the equivalence of ‘social and health harms’ with ‘ultra prohibition’ and ‘commercial production’. It is absolutely clear that legally regulated commercial production is far less harmful than prohibition.
Essentially, instead of a ‘U’ shaped curve, we consider an ‘L’ shaped curve is more accurate.
2. The diagram indicates a fundamental objection to the commercial model implemented in Colorado, Washington and Oregon and the report explicitly rejects the Colorado model in favour of the Uruguay model.
We disagree with this. The Colorado model is a proven success with virtually no downsides. The Uruguay model is still a theory which is yet to be proven in practice. This conclusion in the report is therefore not evidence-based. This suggests that wider political or philosophical considerations have been allowed to trump existing evidence.
3. We are concerned about the undue weight given to restricting commercial enterprise. The UK is not a socialist economy and there is a danger of a ‘nanny-state’ attitude which we cannot support. We repeat the point that it seems wider political or philosophical considerations have been allowed to prevail over actual evidence. There needs to be a balance between a ‘cautious approach’ as in 1. above and over-regulation which will only result in a continuing criminal market. The UK is a market economy and if the legal market is too strict and rigid, the illegal market will flourish.
4. We have very grave concerns about the cannabis social club (CSC) model which provides significant opportunity for the corruption of those involved into major criminal enterprises with exploitation of both workers and customers. The establishment of such ‘clubs’ is entirely unnecessary given the other more controllable methods of supply and will only lead to diversion and perhaps active marketing of excessive production through criminal networks. In other words, CSCs are a golden opportunity for the emergence of ‘drug pushers’ and they undermine the whole purpose of cautious regulation.
5. We regard the recommendation not to permit the production and marketing of ‘edibles’ as an error. If the other recommendations making raw herbal cannabis legally available are implemented then this will inevitably lead to the production and marketing of unregulated ‘edibles’, undermining the whole purpose of regulation. Far better to learn from the mistakes already made in excessively potent ‘edible’ products and introduce appropriate regulations with reduced dosages.
If anything, ‘edibles’ need regulation far more urgently than the raw product because of the potential for very unpleasant overdosing. To abrogate responsibility for this is an extremely unwise proposal and inconsistent with the whole basis for a regulated market.
6. We would encourage a more positive and supportive approach to enable producer countries such as Morocco, the Lebanon, Pakistan and Afghanistan to supply varieties of cannabis resin and hashish. Encouraging such trade under strict regulation will further undermine criminal activity and offers great potential for better relations and positive ‘soft power’ influence on these countries. We recognise the difficulties involved in this with regard to the UN conventions but consider it is a prize worth working towards.
7. For the same reasons set out above we consider that a refusal to regulate concentrates and vapouriser products undermines the whole purpose of a regulated market. Vapouriser products are almost certainly going to be an important component of the medical cannabis market. These nettles must be grasped. To avoid them is irresponsible.
8. We would argue for far more emphasis on harm reduction information, particularly about smoking and avoiding mixing cannabis with tobacco. As in 7. above, we would actively promote the choice of vapouriser products.
9. In principle we agree with the proposal for three levels of THC content and for minimum CBD content. However, there is no evidence to support the necessity for CBD content as high as 4%. The evidence suggests that levels of 1% or 2% adequately meet the desirable ‘entourage’ effects of CBD. Furthermore, at these levels, existing strains are available. Little consideration has been given to the practicalities of developing three new strains to meet the THC:CBD ratios proposed. To develop such strains and ensure they are stable and consistent is the work of several years, requiring significant investment and so undermines the ability to implement these proposals in timely fashion.
10. We consider that the ‘plain packaging’ proposal is unnecessarily restrictive in the UK’s market economy. We agree with child proof containers but would recommend that far more emphasis is given to content and harm reduction labelling. There is nothing to be gained from restricting the marketing and commercial enterprise of companies wishing to develop brands and packaging styles within strict regulations.
11. For reasons already set out we consider that the restrictions on exterior and interior retailer environments are oppressive and will be self-defeating. The UK is not accustomed to such overbearing and anti-business regulation. Existing pharmacies do not operate under such heavy restrictions and they make significant use of point-of-sale and merchandising techniques.
Overall, we welcome this document and the proposals it contains. One final point that is of significance is that clearly there was no ‘consumer’ representation on the panel and this is obvious in some of the tone and detail of the report. We recommend that account should be taken of consumer opinion in any future development of the proposals.
This Is The Future Of Cannabis. For Medicine, Nutrition And Pleasure.
One of these vape pens contains Blue Dream sativa cannabis oil, 91% THC, the other is Hindu Kush indica cannabis oil, 85% THC and the spare cartridge has the dregs of some New York City Diesel sativa, 85% THC. You can’t tell which is which to look at them but each has a distinctive flavour and effect. They’re not completely odour free but almost.
This is the future of cannabis as a consumer product. It is cleaner, neater, handier, healthier and better for you than raw herbal cannabis. Most importantly, for medicinal applications, it homogenises all the compounds into an oil of consistent quality and content meaning that dosage and effect at last becomes predictable and reliable.
High CBD Oil For Medical Use
I have been investigating this theory for some time but my recent trip to Colorado enabled me to conduct some practical experiments and more thoroughly understand how this idea can work. I am now convinced that this is the way forward for the cannabis industry. Once we achieve legalisation in the UK, which is inevitable, probably in about five years, these pens are how cannabis will become available as a consumer product on the high street. They are also how medicinal cannabis will be dispensed. Your doctor’s prescription will be fulfilled by a cartridge with the appropriate blend of cannabinoids which you screw onto your battery and use immediately. Batteries will also be supplied on prescription, in the same way that syringes or blood glucose meters are for diabetics.
In Colorado dispensaries these pens are already available in a choice of strains and blends. Currently, the popular products contain 250 mg of THC in a blend of cannabis oil and propylene glycol (PG), just as e-cigs contain a nicotine oil and PG.
Alternatively, you can buy the oil of your choice and fill the cartridges yourself. This is undoubtedly the way to do it and a wide choice of oils is available, made by CO2 and solvent extraction processes. The Farm, my favourite dispensary in Boulder, is already supplying cannabinoid blends such as a 60% CBD, 12% THC, 4% CBN product which is clearly for medicinal use. I have no doubt that soon we will see a Charlotte’s Web product and Sativex-like blends with equal ratios of THC:CBD. Other, more sophisticated blends of other cannabinoids and probably terpenes will soon follow.
However, I am certain that some propylene glycol is a good thing. The oil vapes much better when diluted and PG is nothing to worry about, it is in many health, cosmetic and food products. It has many uses. It’s a solvent, humectant (keeps things moist), preservative and it helps absorption of some products. It is non-toxic.
There is further development work to be done. I believe there is a ‘sweet spot’ for the correct amount of PG, probably around 20%. I also think the battery and cartridges can be improved, particularly for medical use. Once this is achieved, a product like this with perhaps a 60:40 THC:CBD ratio should form the basis of an application to the Medicines and Health products Regulatory Agency (MHRA) for a marketing authorisation. It will knock Sativex into a cocked hat. In fact, if GW Pharma aren’t investigating this already then they are failing in their duty to shareholders. I shall certainly be doing all I can to research and facilitate the funding to bring such a product to market.
Yes, this is the future of cannabis. Imagine the packaging, marketing and merchandising opportunities for the recreational market. Understand the overwhelming benefits of this as medicine against the raw, herbal product. Yes, I know some will object and the tired old hippy luddites will say it’s a sell out and many more Big Pharma conspiracy theories will emerge but this is the future. Remember you heard it here first.
Channel 4 Drugs Live. How To Cause Confusion About Cannabis.
Hash
What is this ‘hash’ that looks like weed and this ‘skunk’ that isn’t cannabis?
Channel 4’s ‘Drugs Live:Cannabis On Trial‘ played fast and loose with facts, terminology and ethical considerations.
Cannabis
To be fair, I greatly enjoyed the programme (well I would wouldn’t I) and there was some fascinating science. Particularly about how the brain responds to music when you’re high and about how CBD protects the ‘salience network’, the key to motivation. This gives weight to the theory of an ‘amotivational syndrome’.
In a week’s time though, all that most of the public will remember is Jon Snow saying that using ‘skunk’ was more terrifying than being in a war zone and his distorted reporting of the recent study by which he implied that 25% of people who use ‘skunk’ will become psychotic.
So I am left with very mixed feelings. The pre-publicity was a disgrace: inaccurate, misleading, unethical – words I have already published and I stand by them.
The brazen misuse of the terms ‘skunk’ and ‘hash’ is an appalling error of judgement by Channel 4, Renegade Pictures and yes, sadly, by two scientists for whom I have the greatest of respect: Professors Val Curran and David Nutt.
Why would you choose to use the same word as the gutter press chooses to demonise cannabis? ‘Skunk’ is a scary word and what it really means is a sativa dominant strain with a modest THC content of 8% and only traces of CBD.
As for hash, it also has a specific meaning: the compressed resin, derived from the plant by sieving or by hand rubbing. By definition a more concentrated form of cannabis, yet the programme claimed exactly the opposite.
A far better, more accurate, more scientific and informative shorthand would have been to describe the cannabis as low CBD, high CBD and placebo.
Surely, whether we agree or disagree with their evidence, we are entitled to expect precision and accuracy from scientists?
The fundamental problem with this programme was that there were no cannabis experts present, only detached academics and scientists or cannabis users who were hardly well informed or articulate. I did of course volunteer but for some reason the producers saw fit to exclude anyone from the cannabis campaign or anyone who has both in depth knowledge and real experience.
Unfortunately, this programme will go the same way as all those other earnest endeavours, ‘The Union’, ‘The Culture High’, ‘In Pot We Trust’, etc – all very enjoyable, self-affirming and satisfying but all preaching to the choir. I’ll be interested to see what the viewing figures were for last night’s programme.
Professor David Nutt and his Harm Index.
The best bit was David Nutt’s final conclusion. On his scale of harms, even low CBD cannabis (the demon ‘SKUNK’) is less harmful than alcohol, heroin, crack, meth, cocaine, tobacco and speed. After the study he concludes that high CBD cannabis is the least harmful drug of all.
Cannabis Embarrassment At The Home Office
The re-scheduling of Sativex, the cannabis tincture marketed by GW Pharmaceuticals is causing huge embarrassment at the Home Office.
Everybody’s been able to go along with the white lie up to now that Sativex is some sort of highly complex, super scientific, super medicine containing cannabinoids. True enough, GW Pharma has put millions into development and testing in order to jump through the hoops the government has demanded. At the end of the day though, all Sativex consists of is a tincture, an alcohol extract of herbal cannabis. It’s made simply by gently heating a blend of herbal cannabis in ethanol and then adding a little peppermint oil to taste.
An Honourable Man?
The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Sativex for the treatment of muscle spasticity in MS. I understand that an approval for the treatment of cancer pain is expected shortly. The problem for the Home Office is that Sativex now has to be re-scheduled under the Misuse of Drugs Act 1971. Cannabis is presently in schedule one as having no medicinal value. The Advisory Council on the Misuse of Drugs (ACMD) has recommended this week that Sativex be in schedule four, alongside a variety of minor tranquilisers. However, as the ACMD says, “it will not be appropriate to refer to “Sativex”, which is a proprietary name, in any amendment to the misuse of drugs regulations, and that a suitable description of the relevant component(s) of “Sativex” will have to be scheduled.”
This is going to be tough for James Brokenshire to face up to. GW specifies that Sativex contains approximately equal proportions of THC and CBD but that’s not the whole truth. It also contains as many as 400 other chemical compounds which occur naturally in the plant including at least 85 cannabinoids (nobody is exactly sure how many cannabinoids there are or their effects). You see there’s not really any other accurate way of describing Sativex except to call it cannabis. So how can Mr Brokenshire possibly move it to schedule four? He endlessly repeats the propaganda that “there are no medicinal benefits in cannabis”.
Either Mr Brokenshire has to come clean and accept that his past position was incorrect or he has to promote some further deception.
I trust he will prove to be an honourable man.
Cannabis And Cannabinoids: Pharmacology, Medicalization And Recreational Use
By Professor Roger Pertwee
Discovery of Δ9-tetrahydrocannabinol
Cannabis has been used as a medicine, for religious ceremonies and recreationally for over 5000 years. Indeed, an alcohol-containing tincture of cannabis (Figure 1) was a licensed medicine in the UK until its withdrawal in the early 1970’s.
In contrast, the discovery that cannabis contains (–)-trans-Δ9-tetrahydrocannabinol (Δ9-THC) and that many of the effects experienced when cannabis is taken recreationally are caused by this ‘phytocannabinoid’ was made less than 100 years ago (Pertwee, 2006). These effects include altered mood (usually euphoria); altered perception such that colours seem brighter, music more pleasant and ‘felt time’ appears to pass more slowly than ‘clock time’; an increased desire for sweet food (the ‘munchies’); changes in thought processes; impaired memory…and eventual drowsiness. They can also include increased heart rate, a lowering of blood pressure resulting in dizziness and, at high doses, hallucinations and feelings of paranoia. There is good evidence too that Δ9-THC targets the reward centres of the brain in a manner that can lead to psychological dependence, and that abrupt termination of repeated use of cannabis or Δ9-THC can trigger a transient physical withdrawal syndrome that in abstaining recreational cannabis users most commonly includes disturbed sleep, reduced appetite, restlessness, irritability, sweating, chills, a feverish feeling and nausea.
Some Cannabinoid Pharmacology
The discovery of Δ9-THC was followed by the development of synthetic compounds capable of inducing Δ9-THC-like effects. Results obtained from pharmacological research with some of these compounds culminated in the discovery that they produce many of their central effects by activating specific sites on nerve terminals called cannabinoid CB1 receptors in a manner that influences the normal functioning of the brain (Pertwee, 2006). This finding prompted a search for molecules within our own bodies that can activate these receptors and, in 1992, led to a second major discovery – that we do indeed produce and release such molecules. The first of these ‘endocannabinoids’ to be identified was an ethanolamide of the omega-6 unsaturated fatty acid, arachidonic acid. It was named
‘anandamide’, ananda being the Sanskrit word for internal bliss. It has subsequently emerged that there is at least one other cannabinoid receptor (CB2), that there are other endocannabinoids, and that this ‘endocannabinoid system’ of receptors and endogenous receptor activators plays major roles in the control of our health and in ameliorating unwanted symptoms such as pain.
The search is now on for additional cannabinoid receptors and endocannabinoids. Indeed, we have obtained evidence that ethanolamides, which are converted in our bodies from omega-3 polyunsaturated fatty acids that are found, for example, in fish oil, can both activate cannabinoid receptors and attack cancer cells (Brown et al., 2010).
The Medicalization Of Cannabinoids
Fig. 1. Tincture Of Cannabis
Individual cannabinoids first entered the clinic in the 1980’s (Crowther et al., 2010). The first of these was Nabilone (Cesamet), a synthetic Δ9-THC-like compound that is used to suppress nausea and vomiting produced by cancer chemotherapy. Synthetic Δ9-THC (Marinol) was licensed soon after Nabilone for the same purpose, and subsequently as an appetite stimulant, particularly for AIDS patients. Nabilone
and Marinol were recently joined in the clinic by Sativex: in Canada (2005) for the relief of multiple sclerosis and cancer pain and in the UK (2010) to treat spasticity due to multiple sclerosis. Sativex has also received regulatory authorisation in Spain. Its main constituents are two phytocannabinoids, Δ9-THC and cannabidiol, both extracted from cannabis.
Importantly, whereas exogenously administered cannabis and individual cannabinoids such as Δ9-THC and Nabilone target all cannabinoid receptors in the body and so ‘flood’ the whole endocannabinoid system, endocannabinoids released endogenously are somewhat more selective since they seem to be released in a manner that only targets subpopulations of their receptors. Although such release is often ‘autoprotective’ it can sometimes be ‘autoimpairing’, leading for example to CB1 receptor-mediated obesity. There is, however, currently little interest in developing medicines from compounds that block CB1 receptors, as such a blockade could well also suppress CB1 receptor-mediated autoprotection. Indeed, the CB1 receptor blocking drug, Rimonabant, was recently withdrawn from the clinic because of an increased incidence of depression and suicidality in patients taking it as an anti-obesity agent.
The fact that Cesamet, Marinol and Sativex are all in the clinic is of course an indication that, as prescribed, these medicines do significantly more good than harm. Even so, there is considerable interest in developing a second generation of cannabinoid medicines that display even greater ‘benefit-torisk ratios’ (Pertwee, 2009). Possibilities include compounds that avoid the production of unwanted cannabinoid CB1 receptor-mediated effects by:
(1) Only activating cannabinoid receptors that are located outside the brain and spinal cord.
(2) Only activating cannabinoid receptors in particular tissues such as skin or spinal cord by being administered directly into these tissues.
(3) Activating cannabinoid CB2 but not cannabinoid CB1 receptors.
(4) Being administered at low doses that produce a cannabinoid receptor-mediated enhancement of the sought after effects of non-cannabinoid medicines but are insufficient to produce significant cannabinoid receptor-mediated unwanted side effects.
(5) Boosting the levels of endocannabinoids when these are being released in an ‘autoprotective’ manner, for example to relieve pain.
(6) Targeting ‘allosteric’ sites that we have discovered to be present on cannabinoid CB1 receptors in a manner that will boost the ability of autoprotectively released endocannabinoids to activate these receptors.
Cannabis: A Complex Scenario
Δ9-THC is synthesized in the cannabis plant from a nonpsychoactive precursor, Δ9-THC acid. This process can be greatly accelerated by heat which is why cannabis is usually smoked, often with tobacco, consumed in preheated food or inhaled from ‘volcano’ vaporizers that create fumes by heating cannabis without burning it or producing smoke. Other pharmacologically active phytocannabinoids can also be
formed from their acids by heating cannabis. These include the non-psychoactive yet pharmacologically active compounds, cannabidiol (CBD), Δ9-tetrahydrocannabivarin (Δ9-THCV) and cannabigerol (CBG), each of which has actual (CBD) or potential medical applications. Some of these phytocannabinoids are really ‘fighto’ cannabinoids, their presence in cannabis making it a pharmacological ‘battlefield’. Thus
we have discovered that although CB1 receptors are activated by Δ9-THC, they can be blocked by Δ9-THCV. It has also been found that CBD can oppose certain effects produced by cannabis or Δ9-THC. Indeed, whilst there is evidence that the presence of Δ9-THC in cannabis increases the risk of developing schizophrenia for certain individuals, there is also strong evidence that cannabidiol is a potential medicine for the treatment of schizophrenia. A further complication is that the relative concentrations of different phytocannabinoids are not the same in all strains of cannabis, in all parts of the same cannabis plant or in male and femalecannabis plants, the female flowering heads of sinsemilla (‘without seeds’) being particularly rich in Δ9-THC. This may have important consequences for those who take cannabis either recreationally or for the quite different purpose of self-medication, as high CBD:THC or THCV:THC ratios may lessen the risk from cannabis of developing schizophrenia or cannabis dependence…although probably also alter the perceived nature of a cannabis-induced ‘high’.
Spice
One notable recent event has been the arrival in the recreational cannabis world of herbal mixtures laced with synthetic cannabinoids (‘designer drugs’) such as JWH-018 (e.g. Spice or K2, named after the second highest mountain on earth). These little-investigated synthetic cannabinoids share the ability of Δ9-THC to activate cannabinoid CB1 receptors and hence to produce a ‘high’. Moreover, any of them that
activate these receptors more strongly than Δ9-THC will most likely produce a more intense ‘high’ and perhaps also more serious unwanted effects than usually experienced by recreational cannabis users. They probably also differ from THC in other ways. Thus, although Δ9-THC shares its ability to target cannabinoid receptors with many synthetic compounds, the additional pharmacological actions it possesses provide it with a unique ‘pharmacological fingerprint’ that distinguishes it from many of these other compounds.
Harm Minimization For Recreational Cannabis
One important challenge for the International Narcotics Control Board that monitors and implements United Nations drug control conventions is to select an optimal but workable strategy for minimizing the harm that is now being caused both to themselves and to Society by some of the many millions of people world-wide who currently take cannabis (or Spice) recreationally and also, indeed, by some of those who self-medicate with ‘street’ cannabis. For the UK, options include leaving the present law unchanged and increasing or
decreasing current penalties for the supply and/or possession of ‘street’ cannabis. It would also be advisable to develop strategies directed (i) at discouraging cannabis from being taken by adolescents or other individuals who are thought to be at particular risk from cannabis-induced harm and (ii) at providing advice (a) about combinations and levels of cannabinoids in cannabis that are thought to be the least
harmful and (b) about how to take cannabis as an inhaled unburnt vapour or in other ways that avoid the lung damage caused by smoked cannabis. It will be important that policy makers have discussions with cannabinoid pharmacologists whilst considering these and any other potential strategies for minimizing the harm caused by recreational cannabis.
Brown I, Cascio MG, Wahle KWJ, Smoum R, Mechoulam R, Ross RA, Pertwee RG and Heys SD. Cannabinoid receptor dependent and independent anti-proliferative effects of omega-3 ethanolamides in androgen receptor positive and negative prostate cancer cell lines.
Carcinogenesis 2010; 31: 1584-1591.
Crowther, SM, Reynolds, LA and Tansey, EM (eds). The Medicalization of Cannabis. Witness Seminar Transcript. Volume 40. The Wellcome Trust Centre for the History of Medicine, at UCL. 2010; http://www.ucl.ac.uk/histmed/downloads/c20th_group Pertwee RG. Cannabinoid pharmacology: the first 66 years. Br J Pharmacol 2006; 147: S163-S171. Pertwee RG. Emerging strategies for exploiting cannabinoid receptor agonists as medicines. Br J Pharmacol 2009; 156: 397-411. Professor Roger Pertwee has three degrees from the University of Oxford: MA (in biochemistry), D.Phil. (in pharmacology) and D.Sc. (in physiological sciences). He is Professor of Neuropharmacology at the University of Aberdeen, Director of Pharmacology for GW Pharmaceuticals, co-chairman of the International Union of Pharmacology (IUPHAR) Subcommittee on Cannabinoid Receptors, a co-ordinator of the British Pharmacological Society’s Special Interest Group on Cannabinoids and visiting Professor at the University of Hertfordshire. He has also served as chairman of the International Association for Cannabis as Medicine (IACM; 2005-2007) and as President of the International Cannabinoid Research Society (ICRS; 2007-2008; 1997-1998) and is currently ICRS International Secretary and a member of the IACM board of directors. He was the recipient of the 2002 Mechoulam Award “for his outstanding contributions to cannabinoid research” and in 2005 was recognized to be an “ISI Highly Cited Researcher” and hence among “the world’s most cited and influential researchers” (see Pertwee at http://isihighlycited.com/). His research has focused mainly on the pharmacology of cannabinoids. This he began in 1968 at Oxford University and continued when he moved to Aberdeen in 1974. His research has played major roles in:
• the discovery of endocannabinoids and the endocannabinoid system;
• the recent discovery that ethanolamides formed from omega-3 polyunsaturated fatty acids seem to be endocannabinoids;
• the gathering of evidence supporting cannabinoids for the management of multiple sclerosis;
• the discovery that tetrahydrocannabivarin (THCV) is a phytocannabinoid;
• the pharmacological characterization of certain phytocannabinoids and of novel synthetic cannabinoids, e.g. the phytocannabinoids THCV, cannabidiol and cannabigerol, the first water-soluble cannabinoid (O-1057), the first CB1 receptorselective agonists (e.g. methanandamide), and a widely-used CB2 receptor antagonist (AM630);
• the discovery of a cannabinoid CB1 receptor allosteric site;
• the development of cannabinoid bioassays, some widely used (e.g. the “ring test”).
See also www.abdn.ac.uk/ims/staff/details.php?id=rgp
The Truth About Sativex
Sativex is super strong, concentrated cannabis. Nothing more, nothing less.
GW Pharmaceuticals would have you believe that it’s a “pharmaceutical” product because according to its research that’s what patients prefer. As the GW spokesman puts it, “It’s a pharmaceutical solution, formulated with the ability to deliver a precise dose and with stringent standards of quality, safety and efficacy”.
In fact, what GW does is grow high quality cannabis under pretty much the same conditions as most illegal growers. It uses clonal propagation to ensure consistent levels of cannabinoids. Lighting and hydroponic nutrition is computer controlled with automatic ventilation. It really is no different from the most sophisticated and efficent illegal cannabis farms. It’s a recognised and proven technology now also used by Bedrocan in Holland, the Dutch government’s exclusive medicinal cannabis grower and Gropech in California which is building a new 60,000 sq ft facility in Oakland for a crop worth $50 million per year.
Bedrocan Grow
The difference between these crops from legal and illegal growers is insignificant. It’s similar to buying your tomatoes from the supermarket or the farm shop.
GW Grow
GW takes its high quality cannabis, chops it up and makes a tincture by heating it under pressure with CO2 and then adding ethanol to precipitate an oil. Then, with the addition of a little peppermint oil to mask the taste and some preservative, the filtered liquid is packaged into tiny little aerosol bottles. Each spray delivers 2.7mg of THC and 2.5mg of CBD. What GW doesn’t tell you that it also contains all the other 100+ cannabinoids found in the plant, each of which has its own mechanism of action and effect. It also contains flavonoids, terpines and other compounds. Everything that is found in the plant.
Illegal Grow
I applaud GW Pharmaceuticals for bringing the enormous benefits of cannabinoid therapy into the 21st century. It’s nothing new though. The medicinal value of the plant has been known and widely used for thousands of years. Only in the last century has it been demonised by lies and propaganda. It would be a mistake though to think that Sativex is anything different from the plant itself. It’s just been wrapped up in a marketing and physical package which has enabled stupid and cowardly politicians to accept it.
In fact, Sativex remains just as illegal in Britain as herbal cannabis. Even though it has received MHRA approval for use in the treatment of MS spasticity and may be prescribed by a doctor, it remains a schedule 1 drug under the Misuse Of Drugs Act. The Home Office has indicated that it intends to amend the law but has not yet done so. This means that any pharmacist who dispenses Sativex at present is guilty of exactly the same criminal offence as any street dealer in weed or hash.
The Home Office will, of course, turn a blind eye to this but not to medicinal herbal cannabis even though, in every sense, it is identical to Sativex (except that Sativex also contains alcohol and peppermint oil). The stark idiocy of British law is revealed.
Never before has there been a better example of the how the law is an ass and so are the spineless politicians who support it.
Peter Reynolds 