Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Department of Health

How To Campaign For Cannabis Law Reform Under A Theresa May Government.

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  • Lobbying Parliament

  • If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

  • The CBD Market

  • Medical Cannabis

  • Educating And Influencing Researchers

For cannabis and drugs policy reform, out of 650 MPs, there could not have been a worse person to seize power than Theresa May.  There are a few who come close on both Tory and Labour benches but no one who has such a long record of bigotry, denial of evidence and refusal even to consider the subject.

Senior Tory MPs For Cannabis Law Reform

To be fair, I am a member of the Conservative Party, which to many people involved in the cannabis campaign is a mortal sin but my advocacy is based on science and evidence, not tribalism or wider politics.  In any case, though many find this fact hard to accept, there has always been more support from Tory MPs than Labour. Highly influential and senior Tory MPs such as Crispin Blunt, Peter Lilley and Dr Dan Poulter are powerful advocates for reform. I firmly believe that the only sustainable route to legalisation is commercialisation and the left wing, nanny state, anti-business types are already pushing the ‘Big Cannabis’ scare stories.

So what can we do and what are we doing to advance our cause in these dark days?  Theresa May always has been secretive, inaccessible, unresponsive and entirely disinterested in any opinion except her own.  How can we possibly make any progress with a PM who has already shown she is prepared to cover up or falsify evidence and defines herself by her belief in a supernatural power?

There is more support for cannabis law reform in Parliament than ever before.  It is now official policy of both the Liberal Democrats and the Scottish National Party. The support from Scotland is far more valuable than that from the discredited LibDems.  With the added factors of Brexit and Scottish Independence, the SNP is in a powerful position to advance its policies.  Also, in Ireland, both north and south, public support for medical cannabis reform is exploding.  Michelle O’Neill, SinnFein’s new leader, has pledged medical cannabis reform if she is re-elected (though she has no power to do so!).  Her negotiating position is immensely strong now that the problems at Stormont, the rise of Sinn Fein and the Brexit factor all combine to make a united Ireland a real possibility.

During the coalition government from 2010 to 2015, few doors were closed to us.  Over that period, CLEAR conducted more meetings with ministers and senior politicians than the entire UK campaign had achieved in 50 years.  Because we had support from the LibDems, and introductions from the Deputy Prime Minister, even Tory ministers were ready to see us, even if they were merely paying lip service.  That all stopped with the election of a majority Conservative government and after Cameron stepped down the doors were slammed in our faces, bolted and double-locked.  The campaign has been in the doldrums ever since. Or has it?

The last major achievement of the last few year’s campaigning was the release of the APPG report on medical cannabis in September 2016.  Alongside it, Professor Mike Barnes, CLEAR advisory board member, published his review ‘Cannabis: The Evidence for Medical Use‘.  To all impartial and reasonable observers, these documents should have initiated positive government action towards reform, even if it was only very limited in scope.  But no, Theresa May didn’t leave it to Amber Rudd, her successor as home secretary, she stepped straight in herself on the day of publication, before she could even have read it and dismissed the report out of hand.  This echoes the apocryphal story of James Callaghan, then PM, throwing the 1969 Wooton Report in the bin without even opening it.  Such is the inertia and prejudice that has not softened at all amongst the bigots despite 45 years of science and research proving that there are better, safer, more beneficial options available on cannabis.

Lobbying Parliament

For now, individual lobbying of MPs is our only route to power. Over the years we have refined our approach to this and we know what works.  Getting into ping pong correspondence with an MP is a waste of time.  An initial letter or email needs to be followed up with a face-to-face meeting and a determined focus on getting a tangible result. What sort of result you should look for depends on your circumstances but getting your MP to arrange a meeting with a government minister should be your goal.

If you’re a medical user then you’ll want to meet a health minister, preferably the Secretary of State, if not a junior minister or perhaps an advisor to the Department of Health.  Work with your MP to achieve the best result you can.  Your MP doesn’t necessarily have to agree with you about cannabis but they should facilitate your communication with government, that’s their job. If you’re more interested in the economic or social benefits to be gained from reform, you could ask for an introduction to the Chancellor, a treasury or business minister, or someone at the Cabinet Office who is involved in policy development.  CLEAR can usually provide someone to accompany you on meetings but this must be arranged in advance and agreed with your MP or whoever your appointment is with.  Alternatively, we can provide advice over the telephone on how to approach the meeting, what to ask for and what evidence or supporting material to take with you.

If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

With an intransigent government that does it all it can to evade engagement on this issue, there is more that CLEAR is already doing.  If the government won’t take responsibility and regulate cannabis, then step by step we are going to do it for them.  Someone has to, there is far too much harm and suffering caused by present policy.

The CBD Market

Through 2016 the CBD market in the UK really began to take off.  These are products derived from industrial hemp, grown legally under licence that offer many of the therapeutic benefits of cannabis.  They should, in fact, be more accurately termed low-THC cannabis as apart from crystals and a few, rare examples of isolated CBD, they are whole plant extracts and contain all the cannabinoids, terpenes, flavonoids and other compounds found in the plants from which they are made.  Therefore they offer many of the ‘entourage effect’ benefits but with very low levels of THC.  It was obvious though that this market was heading for problems.  More and more dubious suppliers were starting up, many making brazen claims for the medical effects and benefits of their products and many without any product testing, quality assurance or honest customer service.  The law was then and always has been crystal clear, you cannot make medical claims for a product without it being properly licensed or regulated.  Inevitably, in June 2016 the MHRA stepped in and sent threatening letters to a number of CBD suppliers.

CLEAR took the initiative.  We wrote to the MHRA requesting a meeting.  We engaged with the leading CBD suppliers and our advisory board members Professor Mike Barnes and Crispin Blunt MP were quickly on the case.  The story has already been extensively reported but now, nearly a year on, our efforts are coming to fruition. We led the approach to the MHRA and in the process created what is now the Cannabis Trades Association UK (CTAUK).  It is now recognised by the MHRA, it has established a code of conduct and it is now the gold standard of quality, ethics and legality that can give anyone buying CBD products real peace of mind.  There are still cowboys out there, making false claims, selling products that offer no real benefit and even endangering their customers with products that are illegal under the Misuse of Drugs Act 1971 or the Psychoactive Substances Act 2016.  Now though, customers can go to the CTAUK website and choose a supplier that is operating legally, ethically and within the regulations that the industry itself has established.  We expect the MHRA very shortly formally to endorse CTAUK members as legitimate suppliers of CBD products as food supplements.

Medical Cannabis

Professor Nigel Mathers, Honorary Secretary, Royal College of GPs

Neither can we accept the government’s irresponsible and cruel policy towards people who need cannabis as medicine. So CLEAR has taken a further initiative. After Theresa May’s dismissal of the APPG report, we approached the Royal Colleges of medicine.  We pointed out that whatever the government might say, around one million people are using cannabis as medicine.  Doctors have a duty and an ethical responsibility to educate themselves on the subject and be able to provide properly informed care to their patients.  Our efforts have borne fruit.  Professor Mike Barnes and I have worked with Professor Nigel Mathers of the Royal College of GPs (RCGP).  We will be producing a draft set of guidelines on medicinal cannabis for GPs which will go the next meeting of the RCGP Council and is planned for publication in June 2017.  If the government won’t do it, we will and the medical profession agrees with us.  This will be the greatest practical advance ever made in medical cannabis in the UK.

Educating And Influencing Researchers

Dr Musa Sami, Peter Reynolds

The UK is the most prolific source of research into the harms of cannabis, particularly the tenuous links between cannabis and psychosis.  Despite dozens of studies, mainly from the Institute of Psychiatry at King’s College Hospital, this has never been shown to be any more than statistical correlation.  Most of these studies are confounded by tobacco use but the latest work from Professor Sir Robin Murray and his team shows an even stronger correlation between tobacco and psychosis than cannabis.

Across the world, UK scientists have become notorious for this scaremongering which seems little different from the ‘reefer madness’ hysteria.  To be fair, much of this is down to the UK media which has barely advanced since the 1930s in its reporting.  It provides the environment in which researchers are able to gain funding for research into cannabis harms but hardly ever for cannabis benefits.

CLEAR is now working with the Institute of Psychiatry to develop a new and more balanced way of surveying the effects of cannabis.  Dr Musa Sami has asked us to advise on the construction of a questionnaire on which the Institute will base its future work.

Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.

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doctor-tips-bud-out-of-pot

Unsurprisingly perhaps, the response to the recent call from MPs and peers to legalise cannabis for medicinal use has come straight from the top.  Theresa May’s longstanding reputation as a denier of science and evidence on drugs policy is reinforced by her peremptory dismissal of the expert report.  It seems that, at least in the short term, the UK government is sticking by a policy that is discredited, ridiculous and deeply cruel.

It fell to Sarah Newton MP, minister of state at the Home Office, to respond to a parliamentary question from Roger Godsiff, Labour MP for Birmingham, Hall Green.

Roger Godsiff MP

Roger Godsiff MP

“To ask the Secretary of State for the Home Department, if she will respond to the recommendations of the report by the All-Party Parliamentary Group for Drug Policy Reform Accessing Medicinal Cannabis: Meeting Patients’ Needs, published in September 2016.”

 

Sarah Newton MP

Sarah Newton MP

“The Prime Minister responded to the All-Party Parliamentary Group for Drug Policy Reform’s report ‘Accessing Medicinal Cannabis: Meeting Patients’ Needs’ on the 27 October.

Cannabis is controlled as a Class B drug under the Misuse of Drugs Act 1971 and, in its raw form, currently has no recognised medicinal benefits in the UK. It is therefore listed as a Schedule 1 drug under the Misuse of Drugs Regulations 2001.

It is important that all medicines containing controlled drugs are thoroughly trialled to ensure they meet rigorous standards so that doctors and patients are sure of their efficacy and safety. To do otherwise for cannabis would amount to a circumvention of the clearly established and necessary regime for approving medicines in the UK.”

In other words, this is nothing more than a re-statement of the same position that the UK government has held since 1971 when legal access to medicinal cannabis was halted.  Quite clearly the government has given no consideration at all to the vast amount of scientific evidence and international experience that has accumulated over the last 45 years.  The latest report which took nine months to produce, took evidence from over 600 witnesses and included a review of over 20,000 scientific studies is simply cast aside.  To be honest, I doubt whether it has even been read by Ms May or anyone in the Home Office or Department of Health. This is the standard that now prevails in the UK – government of the people by an unaccountable, out-of-touch, unresponsive cabal of individuals elected by a deeply flawed system that gives democracy a bad name.

On the face of it, the claim that all medicines must be thoroughly trialled seems plausible – but it is not.  It is a misleading half-truth clearly intended to squash the call for access to medicinal cannabis by painting a false picture.

Doctors are allowed to prescribe any medicine, licensed or unlicensed, as they see fit, based on their own judgement. But prescribing of cannabis is specifically prohibited by Statutory Instrument despite the scientific consensus that it is far less dangerous than many, probably most commonly prescribed medicines.

So it’s not a level playing field.  It’s a policy that is based on prejudice and scaremongering about recreational use of cannabis.  Ms Newton’s answer is at best disingenuous but then she probably doesn’t even realise that herself.  For many years Home Office policy has been systematically to mislead and misinform on cannabis and evidently under Ms May’s successor, Amber Rudd MP, such dishonesty continues.

Theresa May MP

Theresa May MP

Something will eventually force the government’s hand to change its absurd position on cannabis. Sadly the very last consideration will be scientific evidence or the will of the people. Such factors hold no sway with  UK governments. Only when enough of the political elite open their eyes and examine their conscience, or some key individuals or their family members, experience the need for medicinal cannabis will change become possible.  Alternatively, political upheaval may present an opportunity. The Liberal Democrats were too cowardly, weak and concerned with building their personal careers when in coalition to advance the cause they now so bravely advocate.  Perhaps the SNP, with 56 MPs, all in favour of medicinal cannabis may be our best hope.

Sarah Newton is merely a puppet of the Home Office bureaucracy.  Theresa May’s mendacious position on all aspects of drugs policy is well established and she is as stubborn and bigoted as they come on such matters.  Only when she, in person, is subject to sufficient pressure will this cruel, ignorant and hateful policy change.

CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis

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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/

 

 

LibDems: Correct On Cannabis Policy, Wrong On Scaremongering.

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The Liberal Democrats are doing great work on advancing the cause of cannabis law reform.  Their policy proposals are sensible and their arguments for change are irrefutable but they are wrong to buy into and sustain the myths and scaremongering that have dominated the cannabis debate for so long.

Cannabis does not cause psychosis.  Stronger strains do not present serious health risks.  Memory loss is not a significant issue and no issue at all in comparison to the health harms of alcohol or tobacco. Cannabis cannot be described as dangerous unless you also apply that word to hay fever remedies, over-the-counter painkillers  and energy drinks.  There is not and never has been any scientific evidence to support these myths.

Of course, we must be sensitive to people’s fears and concerns.  For more than 50 years the British people have been fed a stream of lies and exaggeration by the tabloid media.  The Home Office, right up to today, is engaged in a systematic and deliberate policy to mislead and misinform on cannabis.  Shocking though that fact is, this policy transcends successive governments and continues irrespective of ministers’ views.  It clearly emanates from dishonest and corrupt officials who are determined to pursue their own agenda, irrespective of truth or concern for the massive harms and cost of cannabis prohibition.

lamb 10 min stillNorman Lamb, the Liberal Democrat MP and health spokesperson, who is leading the party’s campaign, is a brave, sincere and conscientious politician. One of the few in Westminster that matches up to the high standards of probity and wisdom that we should be able to expect from all MPs.  Similarly, Nick Clegg, former leader, and Tim Farron, current leader, have spoken out strongly on the need to reform the law. Now is the time for them also to start telling the truth about cannabis, about how its dangers have been vastly exaggerated, how for adults, in moderation, it can actually be very beneficial and far preferable as a choice of relaxant to alcohol. Indeed, if people substituted cannabis for some of their alcohol consumption, it would be a public health revolution.  It would save the NHS billions and transform the health of our society.

The cannabis campaign will not succeed unless we tell the truth. We cannot compromise facts and evidence for the illusory belief that buying into the scare stories will somehow advance the cause.  We need to push back at the scaremongering, acknowledge there are risks but that they are extremely small.  They really only apply to use by children or to behaviour that is analogous to a ‘white cider drinker’.  Consume anything to excess, regularly, without a break, without regard to other aspects of life and it will cause harm but even then, cannabis will cause less harm than any other substance.

As for children, one of the main aims of reform must be to minimise underage use.  Even then, the scare story that cannabis is causing significant mental health problems amongst young people is untrue.  The Department of Health’s own data shows that in the last five years, there has been an average of just 28 episodes per year of care for ‘cannabis psychosis’ in young people.  28 individual tragedies but an insignificant problem in public health terms.

The misuse of the term ‘skunk’ is also unhelpful. The Channel 4 ‘Drugs Live’ debacle last year was  based on reckless, irresponsible overdosing of inexperienced users by a scientist who should know better.  All the time calling the cannabis was called ‘skunk’ when it is a matter of fact that it was silver haze as grown by Bedrocan, the Netherlands’ government producer of medicinal cannabis. Skunk is actually the name of one particular cannabis strain and not an especially strong one.  Cannabis is available in Britain that is twice, sometimes three times as potent as skunk but the word has been selected and promoted by the tabloid press because of its obvious, sensationalist, negative connotations.

Thank you to the Liberal Democrats for the fantastic work they are doing.  All we need now is a little adjustment and focus on truth rather than scare stories.

Written by Peter Reynolds

March 23, 2016 at 6:37 pm

Top UK Soap ‘Coronation Street’ To Run Medicinal Cannabis Storyline.

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izzy corrie

Coronation Street Character, Izzy Armstrong

Could This Be A Breakthrough In The UK Campaign For Medicinal Cannabis?

Cannabis used as medicine has appeared before in UK soaps but the news is that this Coronation Street storyline could be less jokey and trivial and actually deal in science and truth.  If so it could be a major breakthrough against an intransigent government that flatly refuses even to consider the evidence.

Coronation Street is the world’s longest running soap opera still in production.  Each episode reaches an average of between five and eight million viewers.  It is deeply enmeshed in the fabric of British working class culture.  If it puts a positive spin on medicinal cannabis it could change public opinion quicker than almost anything else.

Most senior politicians know the truth about medicinal cannabis but refuse to act, leaving millions in unnecessary pain and suffering for fear of a media backlash.  But the media is changing too.  Aside from a few individual dinosaur journalists and the bigots who edit the Daily Mail and Daily Telegraph, the rest of the media is pretty much onside.

population membership adThe UK government’s position is nothing short of ridiculous, particularly given developments throughout the rest of the world.  Look to Australia for the latest progressive, evidence-based change in policy, where very soon 23 million people will gain legal access to medicinal cannabis.

A positive Coronation Street storyline will give the cowards in the Department of Health and the refuseniks in the Home Office a way out. It is inevitable that reform will come. This could mean it is sooner rather than later.

Written by Peter Reynolds

December 19, 2015 at 2:11 pm

Another Pack Of Lies On Cannabis From The UK Government.

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bedrocan2

Yet another cannabis petition amongst hundreds of similar pleas was filed earlier this autumn.  This one though is more tightly focused on removing cannabis from schedule 1, which defines it as having no medicinal value.  The petition is also commendably concise but characterises itself as a ‘demand‘ that cannabis be rescheduled, an unfortunate choice of words.

resched petition graphicNevertheless, congratulations are due in that it has exceeded the threshold of 10,000 signatures which means the government must respond.  That response is now in and it is predictably dishonest, dismissive and authoritarian in its tone.  The Home Office has responsibility for drugs policy so it has drafted the response but it surely must have consulted with the Department of Health.

In fact, I was told only this week by a senior minister that “… the search into the medicinal use of cannabis is something that falls within the jurisdiction of the Department of Health.”  That may be a subtle shift in policy from which we can draw some hope.  But I fear that the response to this petition offers no hope at all.  It is stubborn, obstinate, inaccurate and in denial of evidence and experience.

To be clear, the Home Office has been systematically lying and misleading the British people about cannabis for at least 50 years.  The Department of Health is timid on the issue, leaves the public statements to the Home Office heavies and seems more interested in generating fee income for the Medicines and Healthcare products Regulatory Agency (MHRA), than in actually treating patients effectively.

I analyse the response paragraph by paragraph.

“Herbal cannabis is listed in Schedule 1 as a drug with no recognised medicinal uses outside research. A substantial body of scientific evidence shows it is harmful and can damage human health.”

By far the majority of scientists and doctors now recognise that cannabis has real and significant medicinal uses.  Of course it is possible that cannabis can cause harm, as can any substance.  However, there is no scientific evidence that shows cannabis as being any more harmful than over-the-counter medicines or many common foods.  Professor Les Iversen, chair of the Advisory Council on the Misuse of Drugs, is on the record saying: “cannabis is a safer drug than aspirin and can be used long term without serious side effects”.

“The Government will not encourage the use of a Schedule 1 controlled drug based on anecdotal evidence. It is important that a medicine is very thoroughly trialled to ensure it meets rigorous standards before being licensed and placed on the market so that doctors and patients are sure of its efficacy and safety. “

It is not the government’s role to encourage the use of any drug as medicine, that is the role of a doctor.  Only by removing cannabis from schedule 1 can that decision be placed in doctors’ hands.  There is a vast quantity of peer-reviewed, published scientific evidence on the  medicinal use of cannabis including human clinical trials. It is false to suggest that only anecdotal evidence is available.  See ‘Medicinal Cannabis: The Evidence’.  Thousands of doctors and millions of patients are sure of the efficacy and safety of cannabis based on existing research, trials and experience.  Many commonly prescribed medicines have nowhere near as much evidence behind them as cannabis.

“Cannabis in its raw form (herbal cannabis) is not recognised as having any medicinal purposes in the UK. There is already a clear regime in place to enable medicines (including those containing controlled drugs) to be developed and subsequently prescribed and supplied to patients via healthcare professionals. This regime is administered by the Medicines and Healthcare products Regulatory Agency (MHRA), which issues Marketing Authorisations for drugs that have been tried and tested for their safety and efficacy as medicines in the UK.”

The lack of recognition for the medicinal purposes of cannabis is a grave error with no evidence that supports it.  Cannabis is a traditional medicine which recorded history shows has been used safely and effectively for at least 5,000 years. The only thing that stands in the way of cannabis being prescribed by doctors is its schedule 1 status.  The MHRA is a diversion and is irrelevant.  It exists to trial and regulate new medicines and requires a £100,000 application fee before very costly clinical trials take place. This is an unnecessary obstacle to a traditional medicine which contains more than 400 compounds.  The MHRA process is designed for potentially dangerous, single molecule drugs and is not applicable to cannabis.

“It is up to organisations to apply for Marketing Authorisation for products that they believe have potential medicinal purposes so that these can be subject to the same stringent regime and requirements that all medicines in the UK are subjected to.”

Many substances and drugs which have medicinal purposes are regulated either as Traditional Herbal Products or food supplements.  It is the schedule 1 status of cannabis which prevents it being regulated and controlled in this way which is far more appropriate given its very low potential for harm and the very wide range of conditions for which it can be useful.

“Since 2010 UK patients can use the cannabis-based medicine ‘Sativex’ for the treatment of spasticity due to multiple sclerosis. ‘Sativex’ can also be prescribed for other conditions at the prescribing doctor’s risk. ‘Sativex’ was rigorously tested for its safety and efficacy before receiving approval, and is distinguished from cannabis in its raw form. It is a spray which is standardised in composition, formulation and dose and developed to provide medicinal benefits without a psychoactive effect. Due to its low psychoactive profile ‘Sativex’ was rescheduled from Schedule 1 and placed in Schedule 4 Part 1 to enable its availability for use in healthcare in the UK.”

Sativex is a massively expensive form of cannabis oil which is not prescribed because of its cost.  It is at least 10 times the price of Bedrocan medicinal cannabis as regulated by the Netherlands government which could be immediately made available in the UK.   It is a deliberate falsehood to claim that Sativex does not have a psychoactive effect.  The statutory document ‘Summary of Product Characteristics’ describes “euphoric mood” as a “common”  side effect.  The scheduling of Sativex in schedule 4 is a deception requiring 75 words falsely to distinguish it from other forms of cannabis whereas every other drug in every other schedule requires just one word.

“The MHRA is open to considering marketing approval applications for other medicinal cannabis products should a product be developed. As happened in the case of ‘Sativex’, the Home Office will also consider issuing a licence to enable trials of new medicines to take place under the appropriate ethical approvals. “

Cannabis, which contains 400 + compounds is not suitable for MHRA regulation which is designed for single molecule drugs which are potentially dangerous. There is no significant danger from the use of cannabis when prescribed by a doctor.  This is already well established in scientific evidence and the referral to the MHRA is a diversion and an excuse for failing simply to put the decision in doctors’ hands.

“In view of the potential harms associated with the use of cannabis in its raw form and the availability of avenues for medicinal development, the Government does not consider it appropriate to make changes to the control status of raw or herbal cannabis. “

The government has offered no evidence of the potential harms to which it gives such weight.  No “development” of cannabis is required.  It is a traditional medicine consisting of the dried flowers of the cannabis plant.

“The Government’s view is that the Misuse of Drugs Act 1971 and regulations made under the Act continue to facilitate the development of medicines which are made from Schedule 1 controlled drugs. The legislation is aimed at protecting the public from the potential harms of drugs and is not an impediment to research into these drugs or development of medicines.”

The government’s view is intransigent and as demonstrated by this response is ignorant of the available evidence.  This response reinforces the government’s clear intention not to consider the evidence and simply to deny it.  The evidence shows that the potential harms of cannabis as medicine are trivial and inconsequential.  If its schedule 1 status was not an impediment to research, there would already be a great deal more research into cannabis as medicine.

“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.”

The Home Office is entirely untrustworthy and dishonest on anything to do with cannabis.  Researchers, scientists, doctors and those already using cannabis as medicine simply do not trust anything it says on the subject based on long experience of its calculated dishonesty and misinformation.

On The Eve Of The Cannabis Debate, CLEAR Meets Top Government Minister.

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letwin pjr

Oliver Letwin MP, Cabinet Office Minister. Peter Reynolds, President of CLEAR

Today, Friday 9th October, in advance of Monday’s cannabis debate in Parliament, I met with Oliver Letwin, the Cabinet Office minister with responsibility for the implementation of government policy.

According to The Independent, Oliver Letwin is “probably the most powerful person in the government after the Prime Minister and Chancellor”.  I first met with him back in July and he agreed to investigate the possibility of cannabis being available on prescription. When the cannabis debate was announced, I asked to see him again before the debate took place and he very generously arranged to see me just in time.

Monday’s debate will be the first time in nearly 50 years that MPs have had an opportunity to consider the subject.  Throughout the world, more and more governments are waking up to the huge damage that cannabis prohibition causes. Nearly all the harms around cannabis are not caused by cannabis itself but the laws against it. Prohibition of anything for which there is huge demand inevitably creates a criminal market. More than three million people in the UK choose to use cannabis regularly. We consume more than three and a half tons every day and spend more than £6 billion every year, all of which goes into the black economy.

Since the early 20th century, acres of newsprint have been devoted to telling us how harmful cannabis can be.  The alcohol industry fiercely guards its monopoly of legal recreational drug use.  It has enormous influence in government and its £800 million annual advertising spend give it great power over the media.

But the truth is becoming clear. Scientific evidence and real world experience show that compared to alcohol and even common painkillers and over-the-counter medicines, cannabis is very, very safe.  Concerns about mental health impacts are proven to be wildly overblown as cannabis use has escalated by many orders of magnitude but mental health diagnoses have remained stable. Increasingly, those responsible for drugs policy realise that abandoning this huge market to criminals only makes things worse. Criminals don’t care who they sell to or what they sell, so children and the vulnerable become their customers and their product becomes low quality, contaminated, often very high strength ‘moonshine’ varieties.

A Win Win Proposal To The UK Government On Cannabis.

Perhaps the most pernicious effect of cannabis prohibition is the denial of access to it a medicine. On this, Mr Letwin has been consulting with other ministers in the Department of Health and the Home Office.  He says he is now convinced that there is a very positive future for cannabinoid medicines. As a result, I hope to be meeting again shortly with George Freeman MP, the Life Sciences Minister. I led a delegation of medicinal cannabis users to meet with him at the beginning of this year. Mr Letwin has indicated to me that it is Mr Freeman’s office that needs to deal with this, so I am hopeful of real progress in the near future.

Mr Letwin warned me that the debate itself will not produce any change in the law and I acknowledge this but it is part of the process that will eventually get us there. I suggested that there is a win win option that could be implemented very easily and quickly. There is huge pressure on the government to act but also great inertia and resistance to change from the old guard. I proposed that if cannabis could be moved out of schedule 1 of the Misuse of Drugs Regulations it would enable doctors to prescribe it and researchers more easily begin the task of developing and testing new products.

The great benefit this would offer to the government is that it would be seen to be responding to the evidence, being progressive and keeping up with the worldwide movement towards reform. However, for the more conservative thinkers, the ‘tough on drugs’ mantra would remain in place. Cannabis would still be a class B drug and all the same penalties would remain in force.  Both sides of the debate could see this move as a success for their argument.

So we all look forward to the debate. As is normal practice, no government ministers will participate but I expect a Home office minister will give some sort of response. We are making progress.  Revolution is not the British way but I do think we can continue with guarded optimism that our message is getting through and the direction of travel is certain.

Written by Peter Reynolds

October 9, 2015 at 1:18 pm