Posts Tagged ‘cannabinoid’
UK Department of Health Has Neither Requested Nor Received Any Advice On Medicinal Cannabis.
“I know nothing. I ask nothing. I understand nothing.”
This is the astonishing reality of the way the UK government is responding to the national outcry for access to cannabis as medicine. They are doing absolutely nothing.
Across the world a revolution is taking place as more and more jurisdictions are introducing legal access to medical cannabis. Medical professionals and patients alike are realising the huge benefits to be gained from re-opening access to this most valuable of medicines. Scientific research is proving beyond doubt that cannabis is a safe and effective medicine for a wide range of conditions. Many pharmaceutical companies are investigating different cannabinoids, extracts and therapies. Most of all, citizens are demanding access to a medicine that has been denied to them for no good reason and that can improve, even save the lives of people of all ages, from the baby with severe epilepsy to the grandparent suffering the effects of aging, even dementia. Cannabis can help improve and maintain good health in all of us.
Yet the UK government is not considering the evidence. Despite even a year long Parliamentary inquiry which recommended permitting access, the Department of Health has not considered nor even asked for any expert advice. My Freedom of Information request has established this beyond doubt. See here: https://www.whatdotheyknow.com/request/395319/response/965315/attach/html/2/1078680%20Reynolds.pdf.html
I have been pressing my MP, Sir Oliver Letwin, on this issue ever since I became his constituent two years ago. Early on he was an extremely powerful cabinet minster, generally recognised as number three in the government after David Cameron and George Osborne but he was swiftly sacked when Theresa May became prime minister. He has already announced he will not stand for re-election to the next Parliament.
Meeting with Sir Oliver Letwin MP
To be fair, Oliver has always listened to me politely and attentively. We have met on about half a dozen occasions and we frequently exchange emails. He has been more responsive to me than I had hoped and to begin with he told me he was investigating what was happening in government about the subject. His answer was that the evidence has been considered, expert advisors have been consulted and ministers have concluded that there is not a good case for reform.
I have pressed him again and again, shown him reams of evidence, shared stories with him from across the world, both of scientific research and patient testimonies. While always courteous towards me he has remained resolutely opposed. I could have given up long ago. Indeed, when I asked him why can’t we simply leave it to the professional judgement of doctors whether to prescribe it or not, he gave me an answer straight out of a ‘Yes Minster’ script. He said: “But then they would prescribe it.”
At the beginning of this year I asked him once again for assistance in putting me before a minister to advance my case. He replied:
“We have discussed this issue before, but I am happy to set out the reason why I will not support your proposals. The Department of Health have, as you know, considered this issue, have taken advice on it from their professional public health advisors, and have concluded that the gains in healthcare arising from the legalisation of medicinal cannabis (as opposed to cannabinoids) would not be sufficiently great to outweigh the risk of abuse.”
It seems that, at best, Sir Oliver is mistaken. I have written to him again asking for comments on the FOI response.
Whatever reply I now receive, I urge everyone to get on to their MP about this. It is a scandal. There can be no doubt that it is irresponsible and negligent that the Department of Health is so clearly failing in its duty to the country. That’s not to say how very cruel and inhumane this failure is or how much money legal medical cannabis could save the NHS. Jeremy Hunt, the Secretary of State for Health, must be called to account for this.
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/
Top Jersey Doctor Misinforms and Misleads On Medicinal Cannabis.
Dr Nigel Minihane
Dr Nigel Minihane is the head of Jersey Primary Care Trust which represents all GPs on the island. Recently he contributed supposedly ‘expert opinion’ to an article in the Jersey Evening Post about someone who had been juicing raw cannabis for therapeutic reasons. His comments demonstrate an ignorance and lack of knowledge which is unacceptable in a doctor in such a senior position. In conjunction with CLEAR members in Jersey, we have submitted a formal complaint.
Jersey Evening Post, 13th February 2016
Dear Sirs,
On behalf of our members in Jersey, we wish to bring a complaint of misconduct against Dr. Nigel Minihane concerning comments attributed to him and published in the Jersey Evening Post on 13th February 2016.
The article in question is attached to this email. The passage we are concerned about is at the very end of the article where Dr Minihane gives false information about a recent drug trial in France which resulted in one death and several people suffered brain damage.
The trial to which Dr Minhane refers was not “of a cannabinoid substance”, it was of an FAAH inhibitor, known as BIA 10-2474. This drug is designed to inhibit the natural degradation of endocannabinoids, leading, it was hoped, to pain relief through modulation of the CB receptor network. It was therefore neither a cannabinoid substance nor cannabis. See: http://www.nature.com/news/scientists-in-the-dark-after-french-clinical-trial-proves-fatal-1.19189
Dr Minihane’s words were therefore inaccurate and misleading and contribute to the prejudice and misunderstanding around the use of cannabis and cannabinoids as medicine. Dr Minihane is, of course, entitled to his opinion but based on his other comments in the article he is clearly very poorly informed on the subject. There is a vast amount of peer reviewed, published evidence which supports the safety and efficacy of cannabis and cannabinoids as medicine. See attached paper ‘Medicinal Cannabis: The Evidence’. Furthermore, it is well established in the evidence that cannabis is physically addictive, with about 9% of regular users developing dependence which is characterised by physical withdrawal symptoms including insomnia, lack of appetite and headache.
We understand that Dr Minihane is head of the Jersey Primary Care Trust and the Jersey Evening Post will have asked him to provide an expert opinion. The information he provided was inaccurate, misleading and reckless. In our view it falls well below the professional standard that one is entitled to expect from any doctor. It is woefully inadequate in the case of a doctor in such a senior position who holds himself out as an expert yet communicates false information to the public through the media.
We would be grateful if you would consider this complaint at your earliest opportunity. We are able to provide oral evidence in support and to suggest witnesses resident in Jersey who endure unnecessary pain and suffering due to medicinal conditions that coud be treated by cannabis if the PCT was properly assessing and considering the evidence.
Yours faithfully
Peter Reynolds
President
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.
There Is No Scientific Evidence That Cannabis Cures Cancer In Humans – Yet.
Cannabis Oil
Most of the evidence concerning cannabis and cancer is in vitro or in vivo (animals). There is virtually none in humans, only human cell lines in petri dishes. There is no evidence of a curative effect. The only clinical trial was purified THC fed directly into glioma brain tumours in nine patients. Eight showed some benefit but all were dead within one year.
The evidence almost certainly will come but it does not yet exist and may require specific extracts, concentrates or other processes to produce reliable, consistent, clinical results.
This is a pre-publication extract from ‘Medicinal Cannabis:The Evidence’, the most comprehensive and up to date review of the evidence on medicinal cannabis, shortly to be published by CLEAR.
Studies And Clinical Trials
Cancer
The anti cancer properties of THC, CBD, CBG and other cannabinoids are well established. Scientists have been investigating them since the early 1970s and more than 1100 papers on cannabinoids and cancer have been published. (42)
It is also well established that cannabis helps with the side effects of cancer treatments, particularly nausea and lack of appetite. (43,44,45,46)
Cannabis may also help alleviate anxiety, depression, insomnia and mood disorders in cancer patients. However, some patients may find exactly the opposite results (47)
A very large quantity of anecdotal reports detail remarkable results with cannabis oil on many different forms of cancer. (48) One of the most important properties of cannabis as a cancer therapy is that it is non-toxic and even if little therapeutic effect is achieved, it causes little harm.
On balance, while there is good evidence of anti cancer properties in vitro (human cell lines) and in vivo (animal) studies, there is little evidence of actual results in humans except in the treatment of basal cell carcinoma (49). However, few would disagree that the palliative value of cannabis is of great benefit to many cancer patients. (50)
Clinical trials are underway on cancer pain (51) and the treatment of glioma brain cancer (52).
These selected studies indicate the evidence currently available.
Cannabinoids and cancer: potential for colorectal cancer therapy. Biochem Soc Trans. 2005. http://www.ncbi.nlm.nih.gov/pubmed/16042581 (53)
A pilot clinical study of Δ9-tetrahydrocannabinol in patients with recurrent glioblastoma multiforme, British Journal of Cancer, 2006 http://www.nature.com/bjc/journal/v95/n2/full/6603236a.html (54)
Cannabinoids for Cancer Treatment: Progress and Promise. Cancer Res. 2008. http://cancerres.aacrjournals.org/content/68/2/339 (55)
Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating the Cross-talk between Apoptosis and Autophagy. Mol Cancer Ther., 2011. http://mct.aacrjournals.org/content/10/7/1161.long (56)
The intersection between cannabis and cancer in the United States. CROH, 2011. http://www.croh-online.com/article/S1040-8428(11)00231-9/fulltext (57)
Cannabinoids: a new hope for breast cancer therapy? Cancer Treat Rev. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22776349 (58)
Towards the use of cannabinoids as antitumour agents. Nat Rev Cancer. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22555283 (59)
Cannabis Extract Treatment for Terminal Acute Lymphoblastic Leukemia with a Philadelphia Chromosome Mutation. Case Rep Oncol. 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901602/ (60)
Non-hallucinogenic cannabinoids are effective anti-cancer drugs. Anticancer Research, 2013. http://www.sgul.ac.uk/news/news/study-shows-non-hallucinogenic-cannabinoids-are-effective-anti-cancer-drugs (61)
Cannabidiol as potential anticancer drug. Br J Clin Pharmacol. 2013. http://www.ncbi.nlm.nih.gov/pubmed/22506672%20 (62)
Cannabis, cannabinoids and cancer – the evidence so far. Cancer Research UK, 2014. http://scienceblog.cancerresearchuk.org/2012/07/25/cannabis-cannabinoids-and-cancer-the-evidence-so-far/ (63)
The Combination of Cannabidiol and Δ9-Tetrahydrocannabinol Enhances the Anticancer Effects of Radiation in an Orthotopic Murine Glioma Model. Mol.Cancer.Ther. 2014. http://mct.aacrjournals.org/content/13/12/2955 (64)
References
42. PubMed search term ‘cannabinoid cancer’ http://www.ncbi.nlm.nih.gov/pubmed?term=cannabinoid%20cancer
43. Cannabis and Cannabinoids. National Cancer Institute, 2014 http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page5
44. Cannabinoids in medicine: A review of their therapeutic potential. JEthPharm, 2006. http://www.ww.ufcw770.org/sites/all/themes/danland/files/CannabinoidsMedMetaAnalysis06.pdf
45. Review on clinical studies with cannabis and cannabinoids 2005-2009. IACM 2010. http://www.cannabis-med.org/data/pdf/en_2010_01_special.pdf
46. Medical marijuana for cancer. CA: A Cancer Journal for Clinicians, 2014. http://onlinelibrary.wiley.com/doi/10.3322/caac.21260/abstract
47. Cannabis and Cannabinoids. National Cancer Institute, 2014 http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page5
48. Cannabis Oil Testimonials. Cure Your Own Cancer, 2014. http://www.cureyourowncancer.org/testimonials.html
49. Physician’s documentation confirms successful treatment of basal cell carcinoma resulted from the application of a topical cannabis extract. Cannabis Science, 2011. http://www.cannabisscience.com/2011/499-cannabis-science-provides-physician-s-documentation-that-confirms-successful-treatment-of-skin-cancer
50. Cannabis in Palliative Medicine: Improving Care and Reducing Opioid-Related Morbidity. AM J HOSP PALLIAT CARE, 2011. http://ajh.sagepub.com/content/28/5/297
51. Third phase III Sativex cancer pain trial commences http://www.gwpharm.com/Third%20phase%20III%20Sativex%20cancer%20pain%20trial%20commences.aspx
52. GW Pharmaceuticals Commences Phase 1b/2a Clinical Trial for the Treatment of Glioblastoma Multiforme (GBM) http://is.gd/Wac81a
53. Cannabinoids and cancer: potential for colorectal cancer therapy. Biochem Soc Trans. 2005. http://www.ncbi.nlm.nih.gov/pubmed/16042581
54. A pilot clinical study of Δ9-tetrahydrocannabinol in patients with recurrent glioblastoma multiforme, British Journal of Cancer, 2006 http://www.nature.com/bjc/journal/v95/n2/full/6603236a.html
55. Cannabinoids for Cancer Treatment: Progress and Promise. Cancer Res. 2008. http://cancerres.aacrjournals.org/content/68/2/339
56. Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating the Cross-talk between Apoptosis and Autophagy. Mol Cancer Ther., 2011. http://mct.aacrjournals.org/content/10/7/1161.long
57. The intersection between cannabis and cancer in the United States. CROH, 2011. http://www.croh-online.com/article/S1040-8428(11)00231-9/fulltext
58. Cannabinoids: a new hope for breast cancer therapy? Cancer Treat Rev. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22776349
59. Towards the use of cannabinoids as antitumour agents. Nat Rev Cancer. 2012 http://www.ncbi.nlm.nih.gov/pubmed/22555283
60. Cannabis Extract Treatment for Terminal Acute Lymphoblastic Leukemia with a Philadelphia Chromosome Mutation. Case Rep Oncol. 2013. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901602/
61. Non-hallucinogenic cannabinoids are effective anti-cancer drugs. Anticancer Research, 2013. http://www.sgul.ac.uk/news/news/study-shows-non-hallucinogenic-cannabinoids-are-effective-anti-cancer-drugs
62. Cannabidiol as potential anticancer drug. Br J Clin Pharmacol. 2013. http://www.ncbi.nlm.nih.gov/pubmed/22506672%20
63. Cannabis, cannabinoids and cancer – the evidence so far. Cancer Research UK, 2014. http://scienceblog.cancerresearchuk.org/2012/07/25/cannabis-cannabinoids-and-cancer-the-evidence-so-far/
64. The Combination of Cannabidiol and Δ9-Tetrahydrocannabinol Enhances the Anticancer Effects of Radiation in an Orthotopic Murine Glioma Model. Mol.Cancer.Ther. 2014. http://mct.aacrjournals.org/content/13/12/2955
The Miracle Of Healing.
Whatever your religious belief, if any, the stories of Christ’s miraculous healing have persisted for more than 2,000 years. Such legends develop from oral history and we can never be certain how much is truth, how much is myth and what is a combination of both. Those of faith carry their own certainty in their soul. What is remarkable is the coincidence of several factors that together strongly suggest that the Holy anointing oil used by Christ, his disciples and other healers of the time may have contained cannabis as one of its major active ingredients.
The recipe for Holy anointing oil appeared in ancient Hebrew texts and, unsurprisingly, there are conflicting views about translation.
‘Kaneh-bosm’ ‘qneh-bism’, etc, etc are variants on a word used in ancient Hebrew texts which can be interpreted, credibly, as cannabis. So can ‘calamus’ or ‘sweet calamus’. Different sources seem to use the words interchangeably. However, if you add in the other factors, the healing, the region, its flora, the archaeological evidence and the well established use of cannabis in the region at the time then there is a very, very strong hypothesis. To anyone who understands the miraculous healing properties of cannabis, now explained by modern science it seems common sense.
One CLEAR member, David Boylan, wrote these beautiful words about his faith and cannabis:
“God must have spent a lot of time and effort to produce your endocannabinoid system.
An incredibly complex neurological system in everyone, with the sole purpose of being a receptor for cannabinoids. That must have taken our creator a lot of thought and effort to design…
Trillions of cells devoted to receiving THC and other compounds found ONLY in cannabis. God also ensured that this plant shows up all over the world and grows all around man where ever he looked… So God took all that care for what?
Did God say – “Let there be cannabis”? Then said “Let man have an endocannabinoid system which is stimulated only by cannabis”?
Then did he say…”And now let man get an £80 fixed penalty ticket if man uses it?? Did he say that? NO! Makes no sense, and there is nowhere in the bible I can find that.
I can’t see why Christians don’t have a problem with the government making Gods work illegal? Who are the government to ban God’s work?
It must have been God’s intent for us to at least experiment with cannabis.
That is my only logical conclusion, knowing the facts about the endocannabinoid system. The only conclusion I can make on a creator and pot.”
References:
http://www.freeanointing.org/cannabis_in_the_holy_oil.htm
http://patients4medicalmarijuana.wordpress.com/marijuana-info/marijuana-in-the-bible/jesus-cannabis/
http://cannacentral.com/news/cannabis-christianity-and-the-great-kaneh-bosm-debate-did-jesus-use-pot/
Synthetic Cannabinoids. A Nasty Business, By Nasty People, With Nasty Results.
Totnes, Devon. Worldwide Centre For Synthetic Cannabinoids
Cannabinoids are powerful substances. They are fundamental to life. With that power comes danger. Modern science and chemistry allows unscrupulous businessmen to exploit and endanger young people as they follow the perfectly natural path of all youngsters – to experiment and to get “high”.
In mammals, birds, reptiles and fish, the endocannabinoid system regulates all aspects of physical and mental health. Evolution, Mother Nature, God, Science – whatever name you assign to it – has endowed the cannabis plant as the only natural source of cannabinoids outside the body. Self-evidently, we are in a chicken and egg dilemma here about names and terminology but the facts remain the same, cannabinoids are vital substances. The cannabis plant exists in a symbiotic relationship with mankind. No wonder that some call it sacred.
The great immoral evil that is prohibition seeks to deny access to cannabis. So, in our modern, technological world, inevitably, people find a way to circumvent the law. This was the birth of “legal highs”, the creation of “analogues” or slight molecular variations of delta-9-tetrahydrocannibinol (THC), notorious as the ingredient in cannabis that gets you “high”. In fact, the benefits of cannabis are much more complex than that. It is the interaction of around 100 cannabinoids in the plant together with terpines, flavonoids and other compounds that produce the delightful and therapeutic effects.
The effect of synthetic cannabinoids – “Spice” was the biggest brand name ever – is vile. It is really, truly horrible. It has none of the inherent, natural, protective balance of real cannabis. It causes paranoia, anxiety, fear, delusions, all the symptoms that describe psychosis, the term that has been used to demonise cannabis which, in its natural form, is actually very safe and contains anti-psychotic agents. Worse than that, Spice can lead to elevated blood pressure, heart palpitations, seizures and vomiting. As well as the lack of natural, counterbalancing ingredients, it is also believed to bind more strongly to the cannabinoid receptors, increasing the duration and potency of its effects.
In Britain, the centre of the synthetic cannabinoid business is Totnes, an apparently sleepy market town in Devon. In fact, it is an important hub of the synthetic cannabinoid business in Europe and worldwide. Here, in a grubby warehouse, on a run down industrial estate, completely untested chemical compounds are imported from China, mixed with other ingredients of dubious source and then distributed around the Britain and the world, largely to be sold to young people and children, completely outside the control, moral or legal regulation of any responsibility.
If Shaun Sawyer, the chief constable of Devon and Cornwall wants to do something effective to protect young people, instead of breaking down the doors of people growing a few cannabis plants he should be checking out the contents of this warehouse in Totnes. It is a combination of laziness and ignorance that the police aren’t dealing with this. Spice and other synthetic cannabinoids are far, far more dangerous to our young people and our communities than the natural and generally benign cannabis plant.
Spice and other synthetic cannabinoids are usually dried herbs or plant material that has been sprayed with cannabinoid(s) and marketed as a smoking material. Often the plant material itself has some sort of psychoactive effect. These include blue water lily (Nymphaea caerulea), dwarf skullcap (Scutellaria nana), Maconha brava (Zornia latifolia or Z. diphylla), Siberian motherwort (Leonurus sibiricus), Indian warrior (Pedicularis densiflora) and lion’s tail (Leonotis leonuru). Large amounts of Vitamin E have also been found in some samples, possibly to mask detection of the cannabinoids. The cannabinoids themselves are usually JWH-018, JWH-073, JWH-200, CP-47,497, HU-210 and cannabicyclohexanol. They might be used individually or in any ratio or combination that is convenient or profitable.
From 23rd December 2009, these known ingredients of Spice were prohibited and are now “controlled” under the Misuse of Drugs Act 1971 as if they are cannabis. However, they are very difficult to detect and many more synthetic cannabinoids have been developed. In Totnes there may be a large amount of left over Spice, re-packaged as something else, possibly even mixed with new synthetics which this “Mr Big” has formulated for him by his expert chemist who he told me is based in Austria. Who knows what these products contain? Mr Big and the Austrian chemist engage in frequent email correspondence and samples are sent back and forth as ever more effective attempts are made to evade the law and produce stronger and more profitable chemicals.
A year or so ago I was invited inside this warehouse myself and it opened my eyes to the extremes that some people are prepared to go to make a fast buck. It is dark, dank and clammy. It reeks of slightly rotten or putrid contents. There are boxes and crates spread in no apparent order everywhere. There are large envelopes and plastic containers on shelves containing indeterminate substances that look like dried mushrooms, herbs and plant material. There are also unlabelled powders and pills and, surprisingly for something that is now supposed to be against the law to possess or sell, large quantities of packets that are labelled “Spice”, although what they actually contain is uncertain.
Mr Big is surrounded by a small group of sycophants, some work in his warehouse, some are controlled by gifts and “entertainment”. Downstairs in the dingy warehouse groups of people sit around smoking.
Upstairs in the office is even more worrying. There’s everything you would expect at a thriving mail order business. People working on computers, answering telephones, packing orders and yet more strange substances and distinctly dodgy looking products. I am shown a tea caddy-like container, covered in Chinese decoration and writing. I’m told it is the very latest synthetic cannabinoid imported from China. It’s a fine white powder that glistens slightly. Then I’m introduced to the manufacturing process.
Drug Mixer
A large red “Kitchen Aid” food mixer, the sort you would find in a professional kitchen, is taken off the shelf and Mr Big produces a football sized lump of squidgy, black, supposedly inert, base material. Yes, it looks just like squidgy, black hash but what exactly it contains I have no idea and neither, I should think, does Mr Big. Into the mixing bowl goes a generous handful of this gunk and then the cannabinoid is sprinkled over it. There’s no measurement or calculation or care involved . It’s entirely haphazard and, it has to be said, reckless. The mixer is cranked up to maximum and left to do its work with just one more slug of the white powder for luck. Soon it will be cut into small portions and distributed through head shops and by mail order for unsuspecting people to try.
Yes, I tried it myself. It was horrendous. I am a very experienced cannabis user of over 40 years standing. I’ve tried and enjoyed the strongest varieties, be it Nepalese, Afghan or Pakistani hash, concentrated oil, Thai sticks, the finest medicinal product from Bedrocan in Holland and MMJ dispensaries in the USA. Nothing could have prepared me for the potency and horrible effect of this Totnes poison.
I crumbled a very small amount into my favourite metal pipe, lit it and took a very gentle pull, just enough to get it burning. Within moments I had the most powerful and unpleasant sensation. Every negative, nasty and unwanted effect that I’ve experienced from anything cannabis related was there. Previously, the only bad effects I’ve had from the real thing are when I’ve eaten too much but this was much worse than that. I was instantly on edge, feeling slightly panicky and breathing very quickly. It took fifteen minutes to wear off and the rest of the small sample that Mr Big had given me went straight in the bin.
So what’s the answer to this? Ban it? Lock up Mr Big and throw away the key?
Not at all. Prohibition is a dangerous and irresponsible policy that always causes more harm than it prevents. Remember, Spice is already banned but it hasn’t made any difference to Mr Big and he probably doesn’t even know himself which products in his sordid inventory are allowed and which aren’t. It would probably keep the local drug testing laboratory busy for a year before they manage to go through them all.
These synthetic cannabinoids and all “legal highs” whether or not they’ve yet been banned, are the product of prohibition. They would not exist, nor pose any significant problem, were it not for the ludicrous, self-defeating and harmful policy followed by the British government and other misguided administrations all over the world.
Mr Big and his Austrian chemist will be happy to continue designing new chemicals to sell to our children and there are plenty of unscrupulous Chinese manufacturers who will service their evil trade.
The only answer is to regulate, to introduce a system of licensing, age restrictions and consumer protection. It won’t eliminate the problem entirely but at least it will give us some degree of control, because prohibition provides none.
Mr Big doesn’t give a damn. Although he has a family of his own including small children, all he is concerned with are the hundreds of thousands of pounds he has made by turning Totnes into a worldwide centre for his disgusting trade. We must take responsibility, regulate, control and protect and in due course, Mr Big will get what’s coming to him.
I am pleased to announce that CLEAR will be launching an information campaign about the dangers of synthetic cannabinoids.
The ultimate answer is to end the prohibition of cannabis.
