Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘THC

Lord Monson and CLEAR to Campaign for a Regulated Cannabis Market.

leave a comment »

Lord Nicholas Monson, Peter Reynolds

Lord Nicholas Monson, whose son Rupert committed suicide after he had become psychotic from ‘skunk’, has teamed up with CLEAR Cannabis Law Reform to campaign for a safer, regulated cannabis market.

‘Skunk’ is a form of cannabis with zero or very little CBD that can be harmful to young people and the vulnerable. The criminal market has driven the production of ‘skunk’ with high levels of THC, the psychoactive compound and low levels of CBD, the protective, anti-psychotic compound. The absence of regulation and control has also led to sales of highly dangerous products such as ‘Spice’ which contain an extremely potent, synthetic form of THC without any balancing CBD.

Lord Monson says:

“It is urgent that the government takes the historic step of legalising and regulating more traditional forms of cannabis and puts severe penalties in place for those dealing in skunk.”  

CLEAR Cannabis Law Reform is the UK’s largest and longest established drugs policy reform group.  It campaigns for medicinal cannabis on prescription by doctors and a regulated market for adults.

Peter Reynolds, president of CLEAR, says:

“We are honoured to work alongside Lord Monson towards a safer cannabis market that will reduce harm instead of the present policy that maximises all harms.  Just like the policy that President Trudeau is introducing in Canada and already exists across much of the USA, we must rigorously restrict access by children and those with developing brains and ensure that safe, properly regulated cannabis with a good proportion of CBD is available for adults.”

Written by Peter Reynolds

May 18, 2017 at 2:18 pm

Professor Mike Barnes Speaks Out On the CBD Ban.

leave a comment »

professor-mike-barnes-crop

Professor Mike Barnes, Scientific and Medical Advisor to CLEAR

Professor Mike Barnes, neurologist, scientific and medical advisor to CLEAR Cannabis Law Reform, has issued the following statement.

“It is encouraging that the MRHA is recognising that CBD has medicinal value but it is concerning that many people benefitting from CBD now will suffer in the short term as good quality manufacturers have to stop production pending MRHA approval” 

A redacted copy of the letter now being sent to all CBD suppliers can be seen here.

For some weeks, rumours and half stories have been swirling around about the MHRA taking action on CBD.

Initially a number of suppliers were warned about making medicinal claims, even testimonials from satisfied customers were ruled as unlawful.  Anything which suggested that CBD was a medicine or provided therapeutic effects was ruled out under UK medicines legislation.

Responsible CBD suppliers have known this for some time and were scrupulous in ensuring no such claims were made, even including disclaimers explicitly stating that their products were not for medical use. But as CLEAR has reported many times before, the CBD market is full of cowboys, get-rich-quick scam artists that tell bare faced lies about their products as well as making outlandish claims for the medicinal benefits.  The crackdown from the MHRA was inevitable when these fools put their short term gain ahead of developing a responsible and self-regulating market in which CBD could continue to be sold as a food supplement.

We have seen every sort of bad practice it is possible to imagine.  Some suppliers have attacked all of their competitors, stating that they are the only ‘ethical’ supplier and everyone else is telling lies.  MediPen put all its resources and efforts into marketing and PR without providing proper information to customers about what its product contained.  It achieved great coverage in tabloids like the Metro and the Mirror and even managed to spin a wholly misleading story that the NHS was “trialling” its product (In fact it was at last using an NHS accredited laboratory to test its product contents, that is all).  Another supplier called Sacred Kana was rebranding cheap and nasty Romanian hemp extract and selling a bottle for just over £50, claiming it contained 10,000 mg of CBD.  Testing showed that it actually contained less than 200 mg. Wrapped up in a warm, cuddly hippy-style marketing campaign, they were trying to pass themselves off as the Rick Simpson of CBD when all they are is conmen.

Responsible suppliers did include CBD information on their websites and often linked to scientific studies and research.  Clearly, even this has become too much for the MHRA and now the market is being closed down.  You can thank the greedy idiots, the conmen and the barrow boy salesmen trying to pretend they were scientists.

Of course the truth is that CBD is medicine, so the MHRA isn’t wrong.  Most CBD products are, in fact, low-THC, whole plant extracts, so they were, effectively, a legal form of cannabis.  The therapeutic benefits they offered were not just from CBD but from the ‘entourage effect’, recognised by science as the synergy between all the different components of cannabis.  Unfortunately, we even had some companies promoting the fact that their so-called ‘CBD oil’ actually contained significant proportions of THC and CBN, both ‘controlled drugs’ under the Misuse of Drugs Act 1971.

The crackdown was inevitable but it may leave tens of thousands of people with real health problems as they are no longer able to obtain what they were legitimately using as a food supplement.

Crispin Blunt MP, Political Advisor to CLEAR

Crispin Blunt MP, Political Advisor to CLEAR

Of course, designating CBD as a medicine is inconsistent with the UK government’s position that cannabis has “no medicinal value” but it’s been common knowledge that this is untrue for many years.  The only good news coming out of this debacle is that this could be the beginning of proper, honest regulation of cannabis as medicine. But if we’re looking at clinical trials before CBD can be marketed again, it could be many years away and that’s after someone or some company decides to invest the £250,000 or more that could cost.

CBD products will still be available offshore and you probably will be able to order online and have them delivered by post.  The price is bound to go up and you will be committing a criminal offence by importing an unlicensed medicine but no doubt may will choose to take this risk.

CLEAR is working with the UK Cannabis Trade Association and our Advisory Board members Professor Mike Barnes and Crispin Blunt MP, to try and persuade the MHRA to enter a consultation process and allow CBD to remain available as a food supplement in the short term.

In the longer term, as we know far too well, the only solution is for a proper system of regulation for cannabis. including its use as medicine.

Fast Developing News On CBD And Medicinal Cannabis.

with 2 comments

cbd-molecule-spoon-oil

We learned today that the Medicines and Healthcare products Regulatory Agency (MHRA) has started issuing letters to CBD suppliers advising them that CBD is being designated as a medicine and that sale of CBD products must stop within 28 days.

This will be alarming news to many people.  However, it is a complex situation which has some positive aspects to it.  In the short term, if you are already using CBD products, you would be well advised to stock up as much as you can afford.

CLEAR has been aware of this possibility for several weeks and consequently we have been working with leading CBD suppliers and licensed producers of both low and high THC cannabis on establishing the UK Cannabis Trade Association (UKCTA).  We are already in correspondence with the MHRA seeking to represent all stakeholders, to establish a consultation process on regulating CBD products and to protect the interests of producers, suppliers and consumers.

lovehemp-oilWhat these MHRA letters mean is that for CBD to be sold in future, suppliers will have to obtain either a ‘marketing authorisation’ or a ‘traditional herbal registration’ from the MHRA.

A marketing authorisation can be fantastically expensive, requiring an initial application fee of £103,000 and full scale clinical trials demonstrating safety and efficacy.

A traditional herbal registration is not as expensive, around £6,000 but relies on the product having been “traditionally used to treat the stated condition for a minimum of 30 years, 15 years of which must have been in the European Union (EU).”  It also requires “scientific evidence relating to the safety, quality and traditional use of the herbal product”. It is far from certain that CBD will qualify for this scheme and in any event registration is only granted if the medicine is used for minor health conditions where medical supervision is not required.

CBD is not a ‘controlled drug’ and is not prohibited but most CBD products are in fact low-THC, whole plant extracts derived from industrial hemp, legally grown under licence.  So yes, they are a legal form of cannabis and, of course, according to the Misuse of Drugs Act 1971, cannabis has ‘no medicinal value’.  So, you may well ask, how can the MHRA classify it as a medicine?

MHRA Headquarters

MHRA Headquarters

This is just the first of many complications for the MHRA, the Home Office and the government. Potentially, it could be very positive as it could make the government acknowledge the medicinal value of cannabis and, in effect, force the beginning of cannabis regulation.

It has been certain for some time that many of the CBD products presently on the market are unlawful because they contain levels of THC and CBN which exceed the limits stated in the Misuse of Drugs Regulations 2001. Some CBD suppliers have taken a head in the sand attitude to this, even in some cases foolishly promoting the THC levels in their products. This led to CLEAR removing its  endorsement of one supplier earlier this year and recommending CBD Oils UK instead.

epidiolexThe path ahead is uncertain. The UKCTA is pressing for an urgent meeting with the MHRA. Apart from the advice to consumers to stock up, these will be very worrying times for CBD suppliers and their employees. Another factor is that GW Pharmaceuticals is very close to applying for FDA approval in the USA and an MHRA marketing authorisation for its CBD epilepsy medicine, Epidiolex.

CLEAR, the UKCTA and leading CBD companies are working together to clarify and progress this situation.  We will keep you closely informed of developments.

CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis

leave a comment »

clear-appg-response-fc

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.

A copy of the Powerpoint presentation delivered by CLEAR at the oral evidence hearing can 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/

 

 

Even The Guardian Is Now On The ‘Skunk Scaremongering’ Bandwagon.

with 4 comments

guardian cannabis psychosis headline picRead The Guardian’s Editorial Here

In the last couple of years, even the Daily Mail has shifted its stance on cannabis as it sees opportunities to sensationalise ‘miracle cures’ from medicinal use – the epileptic child now smiling, the cancer patient whose tumour has disappeared. Truth and balance are irrelevant when a dramatic headline is all you’re after.

The Daily Telegraph has become the new home of ‘reefer madness’ with bad science, nasty prejudice and booze-fuelled fear of a safer recreational drug threatening the massive profits of the alcohol industry.

Now, even the Guardian jumps on the ‘skunk scaremongering’ bandwagon with the exaggerated claim that “the risks of heavy teenage cannabis consumption should frighten all of us”. In a backhanded editorial it suggests legalisation because cannabis is dangerous. It claims the consequences of cannabis “abuse are devastating. Psychotic breakdowns smash up lives and can lead to full-blown schizophrenia.” There is little evidence to support such hysteria. In reality, such effects are so rare as to be virtually unheard of and it’s impossible to prove they are caused by cannabis.

Of course we must protect young people, particularly from the high-THC/low-CBD ‘moonshine’ varieties that are a direct result of government policy. However, we cannot compromise facts and evidence for the illusory belief that buying into scare stories will somehow reduce harm. The only way to protect children is by legal regulation with mandatory age limits.

The Guardian makes much of Public Health England’s (PHE) figure that “there are more than 13,000 under-18s in treatment for the consequences of heavy cannabis use in England”. It neglects to mention that PHE also publishes more than 69% are referred by the criminal justice, education and social care systems while only 17% are referred from healthcare and just 11% by themselves or their family. Thus, more than two-thirds are receiving coercive treatment and only 11% actually consider they have a problem.

It is government propaganda that thousands of young people are suffering from mental health problems due to cannabis. Why is The Guardian promoting this myth? Last year, in answer to a Parliamentary question, Jane Ellison MP, minister of state at the Department of Health, revealed there have been average of just over 28 ‘finished admission episodes’ (FAE) for ‘cannabis-induced psychosis’ in young people for each of the past five years.

Of course, each of these 28 cases is a tragedy for the people involved and nothing must distract from that but it clearly shows that in public health terms, ‘cannabis psychosis’ is of negligible significance. To put it into perspective, there are an estimated 3,000 FAEs for peanut allergy each year but we don’t waste £500 million pa on futile law enforcement efforts to ban peanuts!

For 50 years, the Home Office has systematically misled and misinformed the British people about cannabis. Successive generations of young people know they have been lied to. Such dishonest health information is counterproductive. As a result, many children may think that heroin or crack are not as harmful as they have been told.

Cannabis is not harmless but neither is it ‘dangerous’. If you apply that description to it you also have to apply it to energy drinks, over-the-counter painkillers and hay fever remedies. Similarly, whatever scaremongering there is about ‘addiction’, the scientific evidence is that dependency amongst regular cannabis users is slightly less than caffeine dependency amongst regular coffee drinkers – and withdrawal symptoms are similar in nature and intensity.

What we need is evidence-based policy. Government needs to take responsibility for the £6 billion pa cannabis market instead of abandoning our young people and communities to street dealers and criminal gangs. The benefits to be gained from cannabis law reform are reduced health and social harms, massive public expenditure savings, increased tax revenue and proper protection for the vulnerable, including children.

References

Young people’s statistics from the National Drug Treatment Monitoring System (NDTMS), Public Health England, December 2015
Drugs: Young People. Department of Health written question – answered on 20th March 2015.
Relative Addictiveness of Drugs, Dr. Jack E. Henningfield, NIDA and Dr. Neal L. Benowitz, UCLA, 1994

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

with 15 comments

groglo banner

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

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

Finola Industrial Hemp

Finola Industrial Hemp

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

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

Professor Mick Fuller

Professor Mick Fuller

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

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

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

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

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

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

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

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

Mike Harlington, Managing Director of GroGlo

Mike Harlington, Managing Director of GroGlo

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

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

 

CLEAR Withdraws Its Endorsement of UK CBD.

leave a comment »

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

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

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

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

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

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

Written by Peter Reynolds

March 14, 2016 at 4:43 pm