Posts Tagged ‘GP’
Nick Hurd MP, The Times. ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’
Nick Hurd MP
This article by Nick Hurd MP, the Home Office Minister, is re-published from the Times of Friday, 29th June 2018.
It is the most significant recent government statement on cannabis.
“Out-of-date rules must not come before compassion for those who need medicinal cannabis
There are times when life presents a situation for which the status quo is no longer viable; when the case for compassion stands in direct challenge to the rules of the day. This is perhaps no better illustrated than in the case of two young boys and their need for a medicine current legislation does not allow within the UK.
The laws restricting access to cannabis-related medicine in this country have stood for decades. The highly emotive cases of Alfie Dingley and Billy Caldwell have brought home the urgent need to reconsider those rules.
It is impossible not to feel huge empathy for parents expressing their desperation at the difficulty of accessing a treatment they consider essential to the health and wellbeing of their children. I am very aware that behind those high-profile cases stand other families and individuals experiencing the same frustration at the current restrictions.
The home secretary and I are in the process of reviewing the case for rescheduling cannabis-related medicine. This review will be evidence led and should be completed in the autumn.
If medicinal and therapeutic benefits are identified, the intention would be to reschedule cannabis-related medicine as a treatment available through GPs. Whilst recent cases in the media have involved epilepsy this would be open to patients suffering from all illnesses where such treatment is identified to benefit them.
While we await this review, we are confined to working within the existing rules which require a licence. I am delighted that we were able to issue one on behalf of Alfie Dingley — the first ever licence for the long-term treatment of an individual using cannabis-related medicine in the UK.
However, this process took too long and I want to thank Alfie’s family and the clinical team for their patience in working with us to reach this landmark.
We have also issued an emergency licence to treat Billy Caldwell at the request of his clinical team at Chelsea and Westminster Hospital. I have assured Ms Caldwell that Billy will continue to have access to the medicine should his medical team request it and have made clear that we will do what we can to facilitate a long-term licence application for Billy.
We have worked intensively to put in place a much better route for clinicians to secure licences on behalf of their patients until a decision is taken on rescheduling. An expert panel of clinicians will advise Ministers on individual applications. I want to reassure those involved that we are determined to strip this process of any unnecessary bureaucracy. As such, any application can expect to receive a final decision within two to four weeks.
We also want to remove anxiety on fees and are committed to urgently reviewing the fees paid for licences that are awarded as a result of the advice of the expert panel.
The bottom line is that we do not want people to suffer needlessly because of rules and processes that no longer feel fit for purpose.”
A Quick, Easy Guide to The New UK Arrangements For Access To Cannabis As Medicine.
There’s already an awful lot of misunderstanding over the arrangements just introduced for medicinal cannabis and there’s no need for it because, to be fair, the government has been very clear.
There is an interim procedure which will be very, very difficult for most to achieve. You must have very strong support from your doctor and they, together with your local NHS Trust, must be prepared to put in a lot of work, form-filling and pay some substantial licensing fees. It’s all explained here. If you don’t understand it, don’t worry. Your doctor will and it’s only if he/she is prepared to pursue this path for you that you have any chance at all.
There also seems to be an idea that there’s a list of conditions for which cannabis will be available. There’s no truth in this at all. It’s up to your doctor and if they pursue this interim procedure, they will have to make the case why cannabis will work for you.
For most people, you are going have to wait until the autumn when cannabis will be re-scheduled and available on prescription from your GP. It will then be up to you to persuade your doctor. The biggest problem is likely to be that most doctors simply have no understanding of cannabis at all. Now would be a good time to start gathering together all the scientific evidence you can find about using cannabis to treat your condition(s).
Something is going to have to be done about introducing some training for doctors. Since December 2017, the Royal College of GPs has had a set of guidelines ready to issue to doctors but it’s been sitting on them. These were authored by CLEAR, clinical information by Professor Mike Barnes with methods of use and harm reduction information by Peter Reynolds. We are urging the Royal College to make these available to doctors immediately.
Initially the products available are likely to be the Bedrocan range but we expect some of the Canadian companies will quickly make products available. We also expect NICE to re-visit Sativex and reassess its cost-effectiveness. It must be time for some hard negotiation over the price. This is an opportunity for GW Pharma and Bayer to make a significant reduction which would be in their own long term interest.
Cannabis for Medical Use And How The Royal College Of GPs Is Letting Us All Down.
The last couple of weeks have brought an enormous breakthrough for those who need cannabis as medicine but with the release of the government’s interim measures for licensing, the difficulties of how this will work in practice are obvious.
Unless doctors are properly informed and educated about cannabis many patients are going to remain without any help and forced to continue in the illegal market.
The Royal College of GPs was supposed to have issued guidelines to all GPs by the end of 2017 but evidently politics have interfered. It seems that either there has been external pressure from government to hold back or there’s been internal wrangling with some senior doctors opposed to any information being released.
What is astonishing is that this directly contradicts a resolution of the RCGP Council last September when it resolved (unanimously according to reports) to publish guidelines on the use of cannabis as medicine. This raises very serious issues about the governance of the Royal College and also an ethical issue in failing to enable doctors to fulfil their professional duty to patients.
It was at the end of 2016 that CLEAR first wrote to all the Royal Colleges suggesting that guidelines on the use of cannabis as medicine should be considered. The letters went out from Professor Mike Barnes, CLEAR’s scientific and medical advisor. We referred to evidence that about a million people were already using cannabis for medical reasons and particularly the explosion in the use of CBD products. We acknowledged that clearly doctors couldn’t endorse the use of an illegal drug but certainly for CBD and because of the reality of what’s actually happening they needed to be properly informed.
Professor Nigel Mathers of the Royal College of GPs took up our proposal enthusiastically. Through 2017, Mike Barnes and Peter Reynolds of CLEAR attended a number of meetings at the Royal College and detailed plans were made. A formal proposal was put to the council, the ultimate governing body of the Royal College at its meeting in September and approved. It was agreed and announced that the guidelines would be on the college’s website by the end of the year. It was even reported in The Times.
Professor Mike Barnes, CLEAR Advisory Board
Mike Barnes produced the first draft which covered the endocannabinoid system and a summary of the clinical evidence including side effects and a risk/benefit analysis. Peter Reynolds contributed a section on methods of ingestion and harm reduction.
Professor Nigel Mathers finalised the guidelines to make them compliant with the Royal College’s standards. It was his last project before retiring from his position as Honorary Secretary.
Then everything stopped. Both Mike Barnes and Peter Reynolds followed up regularly but were fobbed off, given a variety of excuses until eventually six months had passed and we came to realise that there was a determination from somewhere to prevent publication despite what the council had agreed.
The extraordinary progress of the past few weeks leaves the Royal College stranded. It has let down doctors and through them their patients. It had every opportunity to be in front of these developments and to enable doctors to offer advice that patients are now clamouring for.
Mike Barnes said:
“It is a great pity that there has been this delay. Given the events of the last couple of weeks it is now really important that the RCGP lead the way and publish guidelines for their members, as the public will be asking more and more questions about the medicinal value of cannabis.”
Prejudice against and misinformation about cannabis has been rife for many years. At last that is changing and cannabis for medical use is going to be available legitimately in the UK. We remain ready to assist the Royal College in ensuring GPs get the information they need.
The Views Of Dr Sarah Wollaston MP On Drugs Policy. A Worrying Case Requiring A Good Dose of Evidence.
Dr Sarah Wollaston MP is chair of the cross party Health Select Committee. She was a practising GP but is now the most senior Westminster politician, not in government, who has expertise in health and medicine.
The views she expresses are extremely worrying because they betray a complete failure to take note of the evidence, particularly surprising because of her profession.
I responded by explaining legalising drugs doesn’t mean a free for all, it means the opposite. We have a free for all now because control has been abandoned to criminal gangs. Regulation must be in accordance with a drug’s potential for harm. It’s more urgent to legalise and regulate dangerous drugs. Keeping crack and heroin supply in the hands of criminals maximises harms through unknown strength and contamination as well as violence and street dealing. Clean, safe supplies should be available in conjunction with therapy at reducing doses. It’s simply absurd that cannabis is illegal and this idiotic policy supports crime and creates a £6 billion criminal market with massive consequential harms. It is shameful and national disgrace that our government continues with this idiocy.
There is very little health harm from cannabis. Healthcare records prove this. There are more health harms from peanuts. 99% of harms of cannabis are created by goverment policy. Ignorance, prejudice and cowardice are the defining characteristics of UK drugs policy.
Dr Wollaston suggests that drug consumers are responsible for the violence and criminal activity around the drugs trade. I say this is utter nonsense. It is for the government to take responsibility!! That’s what you’re paid for. Take this market out of criminal hands and PROTECT people. It is disgusting to blame consumers for the harms of the drugs market which are caused by government. How dare you blame consumers for the harms of the criminal drugs market which irresponsible governments have created! UK drugs policy MAXIMISES all health and social harms. We are plagued by ignorant, stubborn, anti-evidence fools in government who are killing our children.
It is shocking that you and colleagues in government can be so trapped in ignorance and denial of the vast amount of evidence from across the world that legal regulation minimises all drug harms. If UK drugs policy was in the dock then it would get a whole life sentence.
This is an appalling abdication of responsibility by a senior politician. Dr Wollaston isn’t in government but she echoes the evil attitude of ministers who cause most harms around drugs by their idiotic policies. It is government that must take responsibility not consumers. Do your job!!
I have written to Dr Wollaston asking if she will meet me so that I may show her the evidence she is overlooking.
Royal College Of General Practitioners. Draft Council Paper – Cannabis For Specified Medical Indications.
This is the document presented to the Council of the Royal College of General Practitioners (RCGP) on 22nd September 2017. The proposal was approved.
APPG: https://drive.google.com/file/d/0B0c_8hkDJu0DRnBfdGRDRXBROUU/view
Barnes: https://drive.google.com/file/d/0B0c_8hkDJu0DUDZMUzhoY1RqMG8/view
MS Society (2017) Cannabis and MS: The Role of Cannabis in Treating MS Symptoms
Cannabis for Specified Medical Indications
Introduction
In the past year, there has been significant interest in the issue of legalisation of cannabis for medical purposes. The All Party Parliamentary Group on Drug Policy Reform made a recommendation in October 2016 that cannabis should be legalised for specific medical indications (https://drive.google.com/file/d/0B0c_8hkDJu0DRnBfdGRDRXBROUU/view). An accompanying report (the Barnes report: https://drive.google.com/file/d/0B0c_8hkDJu0DUDZMUzhoY1RqMG8/view) summarised the current evidence for medicinal use and outlined the known side effects. This proposal now has all party support with over 100 MPs backing the plan.
Other countries have recently legalised, or are about to legalise, medical cannabis, including over half of the US states, Germany, Canada, Australia and Ireland, amongst several others. It has been estimated that over 1 million people use cannabis for medical reasons in the UK on a regular basis. A recent poll showed 68% of the public supported medical usage and only 12% were actively against (REF). A similar number of GPs also supported the concept in a poll published alongside the APPG report.
Some forms of cannabis are legally available, including Sativex for MS-associated spasticity. An important component of natural cannabis, Cannabidiol (CBD), is also legally available without prescription through health food outlets.
It is likely that GPs will be asked, by those with a variety of chronic conditions, for advice on the use of cannabis and related products. It is proposed that the RCGP works with a number of other organisations (including the MS Society) to produce a GP information booklet which offers balanced and reasonable advice on the appropriate use of cannabis, bearing in mind of course, that natural cannabis and the main psychoactive component, Tetrahydrocannabinol (THC), remain generally illegal.
The MS Society has recently reviewed its position on cannabis use as a medicinal treatment for people with MS (MS Society, 2017). The society believes that there is now enough evidence to assert that cannabis for medicinal use, if managed properly, could benefit around 10,000 people who suffer from pain and spasticity as a result of multiple sclerosis.
They want to see all licensed treatments derived from cannabis made available to people who need them. But until that happens they are calling on the UK government to legalise cannabis for medicinal use to treat pain and spasticity in MS, when other treatments have not worked. They believe that people should be able to access objective information about the potential benefits and side effects of using cannabis for medicinal purposes.
Furthermore, they believe it’s both unfair and against the public interest to prosecute people with MS for using cannabis to treat pain and spasticity, when other treatments have not worked for them (MS Society, 2017).
The Proposal
It is proposed that the RCGP works with a number of other organisations (e.g. MS Society, Newcastle University) to produce a GP information booklet which offers balanced and reasonable advice on the appropriate use of cannabis, bearing in mind of course, that natural cannabis and the main psychoactive component, THC, remain generally illegal.
The aim of the GP information booklet would be to offer balanced and reasonable advice on the appropriate use of cannabis.
The booklet would be short and concise (about 4 pages of A4). It will briefly cover the history of cannabis and outline the natural endocannabinoid system found in all humans. The different forms of cannabis and means of ingestion/inhalation would be outlined. It will also outline the current legal status as a Schedule 1 drug but also highlight the legally available varieties of cannabis (Sativex, Nabilone and CBD).
The medical evidence for different conditions will be given in a balanced way with a reasonable appraisal of existing evidence for those conditions with a good evidence base and for those conditions currently lacking in evidence.
It is important that the side effects will be carefully outlined. This would include the known short-term effects of the psychoactive component as well as a discussion of the potential and actual longer-term effects. This would clearly include the concern around triggering schizophrenia-like syndromes and the risks associated with cognitive problems, driving, dependency.
It will be important that the evidence is presented in a reasoned and reasonable, balanced way without any bias either for or against the legalisation argument.
NM, MB, PR
August 2017
CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis
This was the response that CLEAR submitted to the APPG in February 2016. In March 2016, Roland Gyallay-Pap, then managing director of CLEAR and Peter Reynolds, president, were called to give oral evidence to the Inquiry.
A PDF copy of this document may be downloaded here.
Introduction
In June 2015 the All-Party Parliamentary Group for Drug Policy Reform (APPG) published a short report arguing for a rescheduling of cannabis to make it more widely available for medical use. Following the publication of that report there are a number of key questions remaining that it would like to address by means of a Short Inquiry.
CLEAR Cannabis Law Reform has been asked to submit evidence to the Inquiry in answer to these specific questions:
- Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
- What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
- What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
- Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
- What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
- What role could EU regulations play in developing the potential for the medicinal use of cannabis?
We have also added a further response with additional information.
- Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
Yes, we consider that switching cannabis from schedule 1 to a less restrictive schedule would be beneficial, both so that it could be prescribed by doctors as medicine and so that it could more easily be used in research into its use and effects.
Cannabis has been in schedule 1 of the Misuse of Drugs Regulations1 (MoDR) since the Misuse of Drugs Act 19712 (MoDA) came into force. Drugs in schedule 1 are specified as having no medicinal value. However, an inquiry by the House of Lords Science and Technology Committee published in 19983 recommended that doctors should be permitted to prescribe cannabis and that it should be moved to schedule 2. Strangely the government’s response to this recommendation was further to tighten restrictions by the Misuse of Drugs (Designation) Order 20014, which designates cannabis under section 7(4) of MoDA so that it is unlawful “for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply” it.
In fact, cannabis has already been re-scheduled into schedule 4 under the international non-proprietary name of nabiximols (Sativex)5. Although this is specified as being an extract of THC and CBD, it is clear from statements by the manufacturing company, GW Pharmaceuticals, that nabiximols is whole plant cannabis. Dr Geoffrey Guy, founder and chairman of GW, is on the record:
“Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”6
GW pharmaceuticals has confirmed that this quotation is accurate.7
The MHRA has chosen to issue a marketing authorisation8 for nabiximols (Sativex) by regarding it as only a two molecule medicine. The marketing authorisation is therefore at best inaccurate, at worst dishonest.
What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
In 2011, CLEAR commissioned independent, expert research from the Independent Drug Monitoring Unit (IDMU). The report, ‘Taxing the UK Cannabis Market’9, reveals there are three million people using cannabis in the UK regularly (at least once per month). Since then CLEAR has regularly polled its members and followers and consistently one in three of respondents claim at least some part of their use is for medicinal reasons. It is reasonable to estimate therefore that there are up to one million people using cannabis for medicinal purposes in the UK. It is certain that there are hundreds of thousands of medicinal users and previous estimates in the region of 30,000 are far too low.
The most common indications for medicinal use declared by our respondents are chronic pain, fibromyalgia, Crohn’s disease, multiple sclerosis and cancer.
Our interpretation of the responses we have received is that generally cannabis is used as a palliative agent. Some people find it so effective that they consider it to be a ‘cure’ as long as they keep using it. Others find it extremely helpful in reducing the amount of toxic and/or dangerous pharmaceutical medicines they are prescribed. Often the side effects of pharmaceutical medicines are severe and debilitating and cannabis offers a way of minimising these.
CLEAR maintains a Medicinal Users Panel10 which members join in order to gain support in lobbying their MPs and/or attempting to obtain prescribed Bedrocan medicinal cannabis. The active membership of the panel varies between 20 to 80 people. Panel members have also been involved in delegations to meet government ministers and other parliamentarians
What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
In the UK there is very little research into the medicinal uses of cannabis, except that undertaken by GW Pharmaceuticals11. There has been some research carried out into single cannabinoids but the evidence is that the therapeutic effects of cannabis depend on the whole plant ‘entourage effect’.
The allopathic, reductionist approach to medicine, which is reflected in the way that the MHRA regulates medicines, is the fundamental, establishment doctrine that impedes research into cannabis.
Sadly, one of the biggest trials of MS patients, the CUPID study at the University of Plymouth12, intended to look at the many anecdotal reports of benefit, used synthetic THC and consequently the results were disappointing and irrelevant to the claims it sought to test.
It is far easier to obtain funding for research into the harms of cannabis which is undertaken with an almost absurd degree of repetition, most notably by the Institute of Psychiatry at King’s College London (IOPPN).13 It is also worth noting that IOPPN regularly and consistently overstates the results of its research, encouraging the media to report causal effects between cannabis use and mental illness which its research does not support.14
There is a huge stigma around cannabis, largely due to inaccurate, misleading and hysterical press coverage. For instance, neither of the pre-eminent MS patient groups, the MS Society and the MS Trust, will take a stand in support of patients, despite the fact that many use cannabis. Similarly, despite extraordinary human clinical trial results on Crohn’s disease, none of the Crohn’s patient groups will engage with the campaign. Mention cannabis and calls are not returned, people are scared by the stigma. The immediate reaction from all such patient groups is to overlook evidence of benefit and refer to risks to mental health which, in fact, are very low compared to pharmaceutical products. The press, unchallenged by politicians in its disproportionate attention to these risks, bears a heavy responsibility for this stigma and the lack of research.
Unlike many within the reform movement, CLEAR recognises and values the expertise and achievements of GW Pharmaceuticals. However, any doctor or scientist that expresses any interest in medicinal cannabis in the UK is immediately retained or contracted by GW. We receive hundreds of reports of doctors, GPs and consultants, who tacitly and sometimes explicitly support their patients’ use of cannabis but it is impossible to find any doctor who is prepared to speak out publicly. In the few instances where doctors have spoken out on behalf of patients, they have been contacted by Home Office officials and warned. One GP reported that he felt “intimidated”. By contrast, there are tens of thousands of doctors across Europe, Israel and North America who advocate for the use of medicinal cannabis and further research into its applications.
The security and record-keeping requirements for cannabis as a schedule 1 drug15 are wildly disproportionate to the real potential for harm, requiring a high security safe for storage and an audit trail fit for Fort Knox.
In addition the fee for a high THC licence is currently £4700.00 per annum and applications can take more than a year to process. These requirements, delays and corresponding costs severely impede research into medicinal cannabis.
Recently, in response to two government e-petitions, the Home Office issued the following statement:
“In 2013 the Home Office undertook a scoping exercise targeted at a cross-section of the scientific community, including the main research bodies, in response to concerns from a limited number of research professionals that Schedule 1 status was generally impeding research into new drugs.
Our analysis of the responses confirmed a high level of interest, both generally and at institution level, in Schedule 1 research. However, the responses did not support the view that Schedule 1 controlled drug status impedes research in this area. While the responses confirmed Home Office licensing costs and requirements form part of a number of issues which influence decisions to undertake research in this area, ethics approval was identified as the key consideration, while the next most important consideration was the availability of funding.”
We consider this response to be disingenuous and misleading. Cannabis is a special case. It is a combination of hundreds of molecules, unlike other schedule 1 drugs, most of which are single molecules. Also, as is well established in written and archaeological evidence, cannabis has been used effectively for at least 5,000 years as medicine without any evidence of harm.
Furthermore. ethical approval and funding are difficult largely due to the evidence-free scaremongering about cannabis and the consequential stigma, in which the Home Office plays a leading role. Ethical approval and funding do not seem to be a problem in researching potential harms of cannabis. Indeed, as noted above, there is a massive amount of such research even though much of it is repetitive and inconclusive.
Until it is recognised that for many years, under successive governments, the Home Office has been systematically misleading and scaremongering about cannabis, it is difficult to see how an evidence-based decision can be reached. The Home Office regularly makes assertions about cannabis that are completely without evidential support. There is an established prejudice and determination to misinform and this must be tackled at root as it amounts to misconduct and corruption.
Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
There is a vast amount of peer-reviewed, published evidence of the safety and efficacy of cannabis as medicine. Much of this arises from research carried out in the USA, the Netherlands and Israel, where medicinal cannabis regulation has been in place for many years.
It is a populist myth, promoted by the Home Office, the press, the BBC and the prohibitionist lobby, that there is no evidence supporting the use of cannabis as medicine.
In February 2015, a delegation of medicinal cannabis users from CLEAR met with George Freeman MP, the life sciences minister, at the Department of Health who is largely responsible for medicines regulation. At the conclusion of the meeting, Mr Freeman requested CLEAR to produce a summary of the available evidence.
The result is the paper ‘Medicinal Cannabis:The Evidence’16 (MCTE) which has received international acclaim, so much so that in association with Centro de Investigaciones del Cannabis (CIC), a Colombian non profit association, a Spanish language version has been published.
MCTE was submitted to George Freeman MP in April 2015. Since then he has repeatedly refused to meet CLEAR again or respond to us directly, even after multiple requests from individual MPs representing CLEAR members. His only responses, received through third parties, fail to address the evidence at all. He simply refers to the legal status of cannabis, the theoretical availability of Sativex and the MHRA process for issuing marketing authorisations in respect of medicines.
This refusal to engage, acknowledge or properly consider the very large amount of evidence that is available is indicative of an inexplicable prejudice within government. Although conspiracy theories abound, it is difficult to understand why ministers adopt this position.
Cannabis was one of the most used medicines in the British pharmacopeia until only about 100 years ago. It could be restored immediately by a stroke of the Home Secretary’s pen to remove it from schedule 1. This would immediately make it possible for doctors to prescribe medicinal cannabis from Bedrocan17, the Netherlands government’s exclusive contractor.
Bedrocan cannabis is carefully regulated by the Netherlands government’s Office of Medicinal Cannabis. It is available in five different THC:CBD ratios. It is already exported to many countries in Europe and the company has established itself in Canada as well. It is less than a tenth the cost of Sativex for equivalent cannabinoid content and can be consumed either by a medical vapouriser or as an infusion.
No minister in this or any previous government has ever presented a coherent reason for the refusal to allow cannabis to be used as a medicine. Their only response is to fall back on largely spurious or exaggerated claims about the harms of recreational use.
What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
Cannabis would not need to be ‘licenced’ for medicinal use following a change in schedule. As soon as it removed from schedule 1, doctors would be able to prescribe it and businesses interested to grow, process and develop cannabis medicines would be able to obtain cultivation/possession licences from the Home Office.
Medicines are no longer ‘licenced’ in the UK. The MHRA grants marketing authorisations. The initial fee, simply for filling in the application form is £103,000.00, thus prohibiting any but the very largest, established businesses from even considering such a venture. The very term ‘marketing authorisation’ reveals the mindset of medicines regulators which is now more about commercial interests than the evaluation of the safety and efficacy of medicines.
The MHRA does have a regulatory scheme for ‘Traditional Herbal Registration’ (THR) but it only applies “if the medicine is used for minor health conditions where medical supervision is not required.”. An application for a THR for cannabis could not be made while it remains in schedule 1 but, if granted, would not permit its use for many conditions where there is excellent evidence of its efficacy.
The MHRA is locked in an inflexible, unscientific and restrictive process which can only evaluate medicines which are either one or two molecules. Its process is designed for synthetic, potentially very dangerous molecules and is entirely unsuitable for a plant based medicine such as cannabis. This is why, as explained above, Sativex has been improperly regulated as containing only two molecules: THC and CBD.
When the Sativex (nabiximols) patent expires, independent analysis of the medicine would certainly demonstrate that it is whole plant cannabis oil. Presumably alternative and/or generic versions could then be produced. However, by any standards, for all parties, the regulation and scheduling of Sativex is inaccurate, if not dishonest, and needs revision.
If cannabis is removed from schedule 1, most appropriately to schedule 4 alongside Sativex, in our judgement there will be a large number of businesses applying for cultivation/possession licences for research which will eventually result in applications for marketing authorisations. In the meantime, it can only be described as cruel and evidence-free not to permit doctors to prescribe Bedrocan, a safe, effective medicine already regulated by another European government.
It is likely that enabling the prescription of Bedrocan would result in substantial savings to the NHS medicines budget. However, any idea that this could be quantified based on existing evidence is fanciful. Certainly, compared to existing prescription medicines and Sativex, Bedrocan is very inexpensive, probably less than 10 euros per patient per day. However, the complexity of calculating which medicines it could replace by individual, partly or wholly and for how long makes the exercise so hypothetical as to be meaningless.
It must be true that once local, UK-based cultivation of medicinal cannabis was permitted, prices would reduce even further.
What role could EU regulations play in developing the potential for the medicinal use of cannabis?
Aside from France and Ireland (which is moving rapidly towards drugs policy reform), every other EU country has a more intelligent, compassionate and evidence-based policy towards medicinal cannabis. Based on existing policy and its record, the UK government would simply refuse to comply with any EU regulation of medicinal cannabis.
Under the Schengen Acquis (of which UK is a signatory, though not to the full Schengen Agreement), if a medicine is prescribed to a resident of a member state, that resident may travel to other member states with up to three month’s supply under the protection of a Schengen certificate. The effect of this is that a resident of the Netherlands, Belgium, Finland, Germany, Italy, etc. can bring prescribed cannabis, likely Bedrocan, into the UK and use it without restriction.
The crucial test here is residency, so it is not possible for a UK resident to travel to another country, obtain a prescription and then return to the UK legally with cannabis. Presently, a Schengen certificate for a UK resident has to be issued by the Home Office. Strangely and in contravention of this explicit provision, Norway (Non EU but a signatory to Schengen) does permit its residents to obtain prescriptions, usually in the Netherlands, and return home with cannabis.
It is also likely that given the hostility towards EU regulation, adding cannabis into that debate would be counterproductive. It would be used as another stick with which to beat the EU.
Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
As some members of the APPG are aware, CLEAR has been involved in trying to obtain legal access to prescribed Bedrocan since 2012. We now have approximately a dozen members who regularly receive private prescriptions from their doctors (both consultants and GPs) and travel to the Netherlands to have them dispensed.
In all instances, these individuals have either declared their medicine at customs and/or have made prior arrangements with the Border Force, producing supporting documentation.
This is possible because of errors and inconsistencies in the MoDA and the MoDR. All English drugs legislation, including the recent Psychoactive Substances Act 2016, is badly drafted, contradictory and scientifically illiterate.
The principle active ingredients of cannabis are delta-9-THC and cannabidiol (CBD). Bedrocan products are specified with different ratios of these substances. While cannabis is classified in schedule 1, so is delta-9-THC but it is also in schedule 2 described as dronabinol, which is the international non-proprietary name (INN) for delta-9-THC. CBD is not a controlled drug.
Therefore, if a doctor is prepared to write a prescription e.g. dronabinol (Bedrocan 22%) or dronabinol (Bediol 7.5%), three month’s supply of the medicine may be legitimately imported as a schedule 2 drug.
In the past four years only one CLEAR member has been frustrated in this. He had his medicine seized but he was not prosecuted. An appeal against the seizure failed.
Clearly, the vital factor in this scheme is a doctor who understands the law and the science and is prepared to write the prescription.
References
1. Misuse of Drugs Regulations 2001 http://www.legislation.gov.uk/uksi/2001/3998/contents/made
2. Misuse of Drugs Act 1971 http://www.legislation.gov.uk/ukpga/1971/38/contents
3. House of Lords Science and Technology Committee report 1998 http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm
4. Misuse of Drugs (Designation) Order 2001 http://www.legislation.gov.uk/uksi/2001/3997/made
5. Nabiximols (Sativex) https://en.wikipedia.org/wiki/Nabiximols
6. Cambridge News, 24th Jan 2012 http://www.cambridge-news.co.uk/Cannabis-company-enjoys-major-growth/story-22509041-detail/story.html
7. Email corres with Marc Rogerson, GW Pharma, 160312. Attached.
8. Sativex (nabiximols) marketing authorisation, MHRA , 2010 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf
9. Taxing the UK Cannabis Market, IDMU, 2011 http://clear-uk.org/media/uploads/2011/09/TaxUKCan.pdf
10. CLEAR Medicinal Users Panel http://clear-uk.org/pages/medicinal-panel/
11. GW Pharmaceuticals website http://www.gwpharm.com/
12. CUPID study, University of Plymouth, 2015 http://www.ncbi.nlm.nih.gov/pubmed/25676540
13. Institute of Psychiatry at King’s College London website http://www.kcl.ac.uk/ioppn/index.aspx
14. King’s College Confirms Institute of Psychiatry Misled Media On Cannabis Brain Study. CLEAR, 2015 http://clear-uk.org/kings-college-confirms-institute-of-psychiatry-misled-media-on-cannabis-brain-study/
15. Controlled Drugs (Supervision of management and use) Regulations 2013, Dept of Health https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf
16. Medicinal Cannabis: the Evidence, CLEAR, 2015 http://clear-uk.org/static/media/PDFs/medicinal_cannabis_the_evidence.pdf Attached
17. Bedrocan BV website http://www.bedrocan.nl/
May Brings A Fresh Start To The Cannabis Campaign.
Would that we were in spring looking forward to a splendid summer. Instead, in mid-July we are heading into autumn towards what looks like a stern, drab and ominous future. Theresa May is prime minister, perhaps the worst nightmare for those who seek cannabis law reform.
You have to admire her first few days though. What you see is what you get. She is smart, calculated and very, very certain about the nature of the government she will lead. I have no doubt she has a softer, caring side and there is testimony to that effect from those who support her. She is a strong woman, she will be sympathetic to people and causes that she chooses but ruthless and absolute against those she opposes. Our problem is that, as confirmed by both the National Audit Office and Public Accounts Committee, evidence has nothing to do with it. Theresa May’s drugs policy is based on her personal opinions and even the plight of those in chronic pain and disability is unlikely to change her mind even on the medicinal use of cannabis. I remember Norman Baker told me that she simply does not comprehend that cannabis can be a legitimate medicine. The very idea is anathema to her. It is beyond her comprehension. The daughter of a vicar, who attended a convent then a grammar school, she has a lot about her that suggests piety, reserve, self-discipline and control. Admirable qualities but lacking perhaps in empathy with modern lifestyles and values.
Amber Rudd MP, Home Secretary
But this is a fresh start. Amber Rudd, the new Home Secretary, is cast from the same mould as Ms May. My MP, Oliver Letwin, himself disposed of in the new cabinet, has already written to Ms Rudd and asked her to see me. As of today, CLEAR represents nearly 700,000 registered supporters, equivalent to the electorate in more than eight parliamentary constituencies, so I think she has a good reason to give me a few minutes. I will continue to press for a meeting until she or one of her junior ministers agrees to see me.
It can only help that I am now a fully paid-up member of the Conservative Party. I made this decision shortly after the EU referendum and I have also joined the Conservative Policy Forum which works to influence Conservative Party policy from the grassroots. I will be advancing the cause of medicinal cannabis and wider drugs policy reform as quickly and effectively as I can through the party’s established channels. Whether it is a short or long game, it has to get started now.
I do believe this is the best way forward for the cannabis campaign. I will work from within the party of government to try and influence change. It is more than likely that the Tories will be in power for the next 10 years, if not more. Now is the time to get involved, face our opposition, engage with those who have power. Every other UK political party is in disarray.
When we relaunched the Legalise Cannabis Alliance as CLEAR Cannabis Law Reform in 2011, we brought a totally new, professional approach to the campaign. Others have followed and there is now a significant group that understands how to use professional lobbying techniques. The greatest achievement of this has been to get the Liberal Democrats involved and although there remains great resistance amongst party members in the shires, the leadership is very much onside. Sadly, the party itself is as far away from power as it has ever been and, in my view, has swung widely off course in a futile and misguided effort to reverse the referendum result. Such whimsical strategies have always been the LibDems’ problem. Unless a political revolution suddenly makes Corbyn a serious contender then there will be no other party in power but the Tories. This is where we must invest time, effort and all our resources. We must understand how to turn Tory aims, ambitions and viewpoints to our advantage. Which arguments will work and how do we get them across?
Although we now have a more professional campaign and several individuals with real ability, now is not the time to revert to talking amongst ourselves. Conferences, meetings, documentary films and events are all very well but they almost exclusively preach to the choir. Just like the demos and protests that have at last ebbed away, they make those involved feel good and they ramp up morale but they do little to create change. This is no way to make progress. I will ensure that CLEAR is on the front line. It is those who oppose us that we need to be talking to, not those who already agree with us.
Professor Mike Barnes
At the same time, specifically on medicinal cannabis, our focus must be on the medical profession. We published ‘Medicinal Cannabis:The Evidence’ just over a year ago and it has added real credibility to the campaign. In a few weeks when the APPG for Drug Policy Reform publishes its report on medicinal cannabis, Professor Mike Barnes will release his own review of current evidence and it will become the definitive work on the subject. CLEAR will be taking this to GPs all over the country, to the Royal Colleges and particularly to those working in pain management. We already know that thousands of doctors endorse their patients’ use of cannabis for chronic pain, it is time to bring this out of the closet. Doctors and nurses have literally been terrorised into keeping quiet about cannabis. We have first hand knowledge of Home Office officials warning off doctors who have tried to assist their patients by prescribing Sativex off label or recommending Bedrocan. This must stop. We must equip the medical profession with the evidence it needs to be able to do the best by its patients.
I know many will be downhearted by this new government but change is always a good thing. It offers us the opportunity to renew our campaign. Most important, we must walk towards the enemy, not hide in our bunkers, fearful of their response. All over the world, mainstream opinion is turning in favour of cannabis as medicine and wider drugs policy reform. Now is the time to step forward, to do all we can to educate and inform those who are still in the dark. I have set out above what CLEAR’s new strategy will be. Please join us. Become a member. Sign up here. Your first duty? Make an appointment to see your MP. This is the most effective thing you can do. We will publish new guidance in the next few days on how to prepare for and conduct these meetings.
Top Jersey Doctor Misinforms and Misleads On Medicinal Cannabis.
Dr Nigel Minihane
Dr Nigel Minihane is the head of Jersey Primary Care Trust which represents all GPs on the island. Recently he contributed supposedly ‘expert opinion’ to an article in the Jersey Evening Post about someone who had been juicing raw cannabis for therapeutic reasons. His comments demonstrate an ignorance and lack of knowledge which is unacceptable in a doctor in such a senior position. In conjunction with CLEAR members in Jersey, we have submitted a formal complaint.
Jersey Evening Post, 13th February 2016
Dear Sirs,
On behalf of our members in Jersey, we wish to bring a complaint of misconduct against Dr. Nigel Minihane concerning comments attributed to him and published in the Jersey Evening Post on 13th February 2016.
The article in question is attached to this email. The passage we are concerned about is at the very end of the article where Dr Minihane gives false information about a recent drug trial in France which resulted in one death and several people suffered brain damage.
The trial to which Dr Minhane refers was not “of a cannabinoid substance”, it was of an FAAH inhibitor, known as BIA 10-2474. This drug is designed to inhibit the natural degradation of endocannabinoids, leading, it was hoped, to pain relief through modulation of the CB receptor network. It was therefore neither a cannabinoid substance nor cannabis. See: http://www.nature.com/news/scientists-in-the-dark-after-french-clinical-trial-proves-fatal-1.19189
Dr Minihane’s words were therefore inaccurate and misleading and contribute to the prejudice and misunderstanding around the use of cannabis and cannabinoids as medicine. Dr Minihane is, of course, entitled to his opinion but based on his other comments in the article he is clearly very poorly informed on the subject. There is a vast amount of peer reviewed, published evidence which supports the safety and efficacy of cannabis and cannabinoids as medicine. See attached paper ‘Medicinal Cannabis: The Evidence’. Furthermore, it is well established in the evidence that cannabis is physically addictive, with about 9% of regular users developing dependence which is characterised by physical withdrawal symptoms including insomnia, lack of appetite and headache.
We understand that Dr Minihane is head of the Jersey Primary Care Trust and the Jersey Evening Post will have asked him to provide an expert opinion. The information he provided was inaccurate, misleading and reckless. In our view it falls well below the professional standard that one is entitled to expect from any doctor. It is woefully inadequate in the case of a doctor in such a senior position who holds himself out as an expert yet communicates false information to the public through the media.
We would be grateful if you would consider this complaint at your earliest opportunity. We are able to provide oral evidence in support and to suggest witnesses resident in Jersey who endure unnecessary pain and suffering due to medicinal conditions that coud be treated by cannabis if the PCT was properly assessing and considering the evidence.
Yours faithfully
Peter Reynolds
President
Back To The Future Of The NHS
I have grave concerns about the government’s NHS reforms. I feel like it’s Groundhog Day.
I was deeply involved in the last major health service reforms back in the 1990s. I am hearing exactly the same ideas, phrases and promises as we heard then. Haven’t we done this all before?
When the “internal market” was introduced and the first NHS Trusts were “founded”, the idea of marketing was introduced to the NHS for the first time. I saw the opportunity, organised a conference at the QEII conference centre and built a nice business, thank you very much, for several years as an expert in the field. I was an advisor to several health authorities and a number of the new NHS trusts. I undertook marketing and communications audits, ran training courses and I made something of a specialty of designing, writing and producing annual reports. I learned a lot and I felt I contributed a lot. Why is it all being done again?
Marketing is a perfect description of the way the health service should work. It is the management process responsible for anticipating, identifying and satisfying customer needs efficiently. The 1990s NHS model was that “purchasers”, health authorities and GP fundholders, would buy services from “providers”, hospitals and community health services. “Purchasing” was later renamed “commissioning” to reflect how complex the task is. It’s about understanding what services are required and making complex choices as well as actually contracting for them.
Strategic Health Authorities (SHAs) were always a redundant tier of bureaucracy in my view. District Health Authorities (DHAs) were to be the principal commissioners but the plan was that GP fundholders would eventually take over most of it with DHAs becoming centres of expertise rather than administration. Then there was a rather messy fudge between GPs and community health services and we ended up with Primary Care Trusts (PCTs).
There is a huge amount of expertise required in commissioning. The complexity of the tasks involved – understanding, assessing, testing, planning, choosing, contracting and much more, is enormous. GPs will have to buy in that expertise which will build a bureaucracy which we will call – what? We will have gone round in a circle.
One of the biggest mistakes made about the NHS is the endless stream of attacks on managers. Almost all the problems that the NHS has and that people complain about are management problems. NHS managers have a hugely demanding and thankless task for which they are regularly pilloried and censured. They are, actually, crucial to an effective NHS, just as much as the clinicians.
So now we are to have “Foundation Trusts” and GP commissioning. It is the same thing, yet again, under a slightly different name. The NHS is not broken. It is, in fact, greatly improved. It doesn’t need fixing.
We do not need more reform. We need some adjustments. There have been great achievements on waiting times. Now, we need to shift the emphasis towards outcomes. We need targets on quality rather than quantity. It’s a tweak rather than a revolution.
Under Pressure
About four months ago I embarked on a course of medication for high blood pressure. For some time I’d been warned that I was marginal with a reading of 140/90 so I decided it was time to start looking after myself. I was a heavy smoker and drinker. My only redeeming factor was that I walk with my dogs every day for about an hour – and that’s vigorous walking, up and down steep hills.
I was started on a calcium antagonist and within a few days I had virtually lost the will to live. I had no energy at all. I’d lost all motivation. In the most degrading epsiode of all, one morning I found myself prostrate on the sofa watching “Homes Under the Hammer”. That’s when I knew it was serious.
I took myself straight off that poison and went back to see my GP. My blood pressure reading was now 168/100. He advised a change to a thiazide diuretic. Being the not so patient patient that I am, I insisted on a full explanation as far as my “O” level science was capable of understanding.
This time it was more subtle. My energy, motivation and enthusiasm was sapped gradually. As my positive life signs went down my thirst rocketed to absurd proportions. After a month or so I was regularly up six times a night with a raging thirst and a full bladder. When I cleaned out the space behind the passenger seat in my car I had two carrier bags full of empty drink bottles.
In the meantime, I gave up smoking. I give the pharmaceutical industry credit for this. A month of patches and a nicotine inhaler weaned me off the evil weed easily. About this I am both pleased and proud. I have at least one “cigarette moment” every day but I am not going back to it. Although I can recognise no physiological benefit at all (if anything I seem to get more breathless now), I am much richer and everything around me is cleaner as a result.
The next visit to my GP saw my pressure reduced to 150/95. Better but not good enough. He advised me to start taking an ACE inhibitor as well as the diuretic.
I researched ACE inhibitors and was horrified at the range of side effects and contraindications. Then, suddenly, coming fast up behind and undertaking me before I knew what was happening (forgive my blushes) I discovered I was impotent. One embarrassing date and then a dawning realisation that nothing was happening, even involuntarily. No more waking up with a big itch!
I’m not ready to give up my sex life just yet. The one and only criticism I have of my GP is that he never warned me of this side effect. I have also cut my drinking by a huge proportion. From a half bottle of whisky upwards a day I am now comfortable with a single glass of wine or a small beer. In the last few weeks my motivation has gone again. I can’t be bothered with long walks with the dogs anymore. Just half an hour out in the mornings and I’m exhausted. I’m not interested in anything. My occasional lunchtime nap has become a necessity. Sometimes, even before midday I feel so exhausted, I just can’t wait to go back to bed.
Four days ago I stopped the diuretic and yesterday I felt like I had got my life back. I have so much more energy. I’m enthusiastic as I can’t remember for months. I fair romped up the hill with the dogs this morning. My thirst is calming down and I was only up twice last night. My mojo isn’t back yet but I can feel a little twitch developing. Come Christmas time I advise you to lock up your daughters once again.
The punch line? My blood pressure is now 170/110. I may be heading for a massive stroke or heart attack any minute but at least I’ll die happy. Despite giving up smoking and decimating my alcohol consumption, my blood pressure is much worse than when I started. So what does that tell me?
I have no idea at all but at least now I have a smile on my face!
Peter Reynolds 