Posts Tagged ‘Bedrocan’
The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.
Bedrocan, the Netherlands government’s official producer, grows cannabis in which the cannabinoid and terpene content is standardised and consistent. It does this by very careful cultivation techniques which include clonal propagation, continuous analysis and gamma irradiation to eliminate contamination with potentially harmful microbes. Its production facility is Good Manufacturing Practice (GMP) certified.
With the exception of Sativex, which NICE has declared as not cost effective, the Bedrocan range offers the only medicinal cannabis products which could be readily available in the UK. They are also available as oils extracted directly from the raw herbal flowers.
It’s very simple, unless Bedrocan products come within the definition of a ‘cannabis-derived medicinal product’, the very welcome reform announced today by Sajid Javid will fail and most people will have no option but to continue sourcing their medicine from the illegal market.
There is no doubt that the gold standard in safety, efficacy and self-titration is vaporised herbal cannabis of Bedrocan-standard quality. Cannabis that is ingested as oil, either sub-lingually or through the gastrointestinal system, has a substantially different pharmacology and is very difficult to titrate accurately or to deliver its beneficial effects promptly.
Bedrocan provides an immediate solution. GW Pharmaceuticals could also easily turn to providing a similar range of products. One hopes that it could also be prevailed upon to reconsider its pricing of Sativex. It is essential however that new, domestic production facilities are established quickly. Up to now the Home Office has rejected all efforts to set up such facilities, even applications from extremely reputable international businesses that already have licences elsewhere. This policy must be immediately revised.
Dame Sally Davies advised that “only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios”. The ACMD agreed with this, stating that “raw cannabis (including cannabis-based preparations) of unknown composition should not be given the status of medication.” Bedrocan products fully comply with these requirements and it is essential that they are re-scheduled and made available on prescription.
Home Secretary Invites CLEAR To ‘Enter A Dialogue’ On Cannabis Law Reform.
In a letter dated 15th August 2016, Amber Rudd, the new Home Secretary, has invited CLEAR to raise “any queries and concerns” about present UK policy on cannabis. This is the first time since 2006, with Charles Clarke, that the UK cannabis campaign has had any direct contact with a serving Home Secretary. It reflects the reality, now recognised in government, that changes in cannabis policy are imminent.
In recent months, there has been a manifest and significant change in attitudes within the Home Office. We have seen this through the process of obtaining a low THC cultivation licence for our partnership with GroGlo Research and Development. The response from the drugs licensing department has been enthusiastic. There has been no difficulty with our declared purpose of producing CBD oil for sale as a food supplement and we are now in detailed discussions on our application for a high THC licence, looking towards clinical trials for a medical product for chronic pain.
As soon as Theresa May announced that Amber Rudd would be heading up the Home Office, I contacted my MP, now Sir Oliver Letwin, thanks to Cameron’s resignation honours list. Although he will not openly support our campaign, in the past year or so he has been very helpful indeed, meeting with me on roughly a monthly basis and helping me navigate through the Conservative government. He has now put me in direct contact with Ms Rudd and I will be preparing a written submission as a preliminary to a face-to-face meeting.
In accordance with CLEAR policy, our first concern is how we can enable UK residents to gain access to medicinal cannabis on a doctor’s prescription. In practice that means Bedrocan products as there is presently no other source of prescribable, consistent, high-quality, herbal cannabis. I would expect that to change very soon though. Both Canada and Israel look like potential near-future sources. GW Pharmaceuticals is undoubtedly considering entering the market and our venture with GroGlo could shift gear depending on how quickly UK policy changes.
We will also be addressing the need for wider reform and a legally regulated market for adult consumers. Although medicinal access remains the top priority, there is no doubt that more overall harm is caused by prohibition of the recreational market. It is this that creates the £6 billon per annum criminal market which is the cause of all the social harms around cannabis. This will need to be handled much more carefully as, due to nearly a century of misinformation and media scaremongering, many people still retain great fear as to what legal cannabis will mean.
The one thing that has been very lacking in the cannabis campaign is pragmatism. Most campaigners for recreational use continue to be lost in a swirl of ‘free the weed’, teenage angst, outrage, revolution and delight in being a rebellious outlaw. That was until 2011 when CLEAR introduced a new approach which has led to more engagement with government than ever before. The emergence of the United Patients Alliance and now the End Our Pain campaign has helped this but these campaigns are focused only on medicinal use
The fact is that we need to work with Theresa May’s government and the anti-Tory tribalism that many still adopt is nothing but an obstacle to reform.
In addressing Ms Rudd, our overall strategy for wider reform will be:
1. A final separation from the ridiculous ‘free the weed’ movement and ‘stoner’ groups which are incapable of understanding how they are seen and despised by wider society.
2. Differentiation between medicinal use and the more controversial legalisation for adult, recreational use.
3. Shift public attention onto scientific and medical evidence rather than the very poor standard of media reporting.
4. End the fake policy that says ‘cannabis is dangerous therefore it must be regulated’. Educate that nearly all the harms around cannabis are caused by its prohibition, not by cannabis itself.
5. Emphasise the importance of harm reduction information, education about excessive use and essential investment in treatment for those who do suffer health harms.
6. Clarify that decriminalisation is no solution and is a dangerous option that would probably increase harm. The product needs to be sold within a properly regulated environment, careful that over-regulation would support a continuing criminal market.
Another Pack Of Lies On Cannabis From The UK Government.
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.
Nevertheless, 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.
How You Can Help The Campaign For Medicinal Cannabis.
CLEAR is launching a new recruitment drive for its Medicinal Cannabis Users Panel. If you use cannabis as medicine, joining the panel is the most effective thing you can do both to advance the campaign and, in some instances, gain legitimate access to prescribed Bedrocan medicinal cannabis.
The panel has proved itself to be the most effective campaigning method ever used in the UK. As a direct result of the efforts of panel members, in the last two years there have been more meetings with government minsters, officials and senior MPs than the whole campaign has managed in the last 50 years.
You must be a member of CLEAR to join the panel, then you complete a detailed questionnaire providing information on your condition(s) and how cannabis helps. Each applicant is then interviewed by telephone to develop an individual plan. This will depend on a number of factors, such as your relationship with your doctor, your MP, how much time you have available and whether you are prepared to tell your story to the media.
If your doctor is prepared to help, there is now an established route to getting medicinal cannabis prescribed and legally imported into the UK. CLEAR has developed this process through experience working with doctors, MPs, the Home Office and the Border Force. We also have crucial support from the All Party Parliamentary Group (APPG) on Drug Policy Reform and a number of members of the House of Lords. This is on a private prescription basis only. The prescription has to be very carefully written, using exactly the correct wording and, to begin with, you will have to travel to Holland in person to have the prescription dispensed at a pharmacy. Thereafter it may be possible to have repeat prescriptions sent through the post.
Bedrocan is the Dutch government’s official producer of medicinal cannabis. Five different varieties are available at a cost of approximately seven to eight euros per gram. See full details of the different products here.
All panel members are guided in how to approach their doctor and MP. Initial contact should be made by letter or email but then it is important to meet your doctor and MP face to face and provide them with high quality scientific evidence to support your case. CLEAR will offer guidance and help at every stage. If you wish then a member of our executive committee will accompany you to meetings to help you present your case. Whether or not your doctor is prepared to write a prescription for you, we aim to continue leading delegations of medicinal users to meet ministers. We have seen again and again what an impact this can have. When senior politicians who have no experience of medicinal cannabis meet genuine, decent, ordinary people with families and careers who tell their story with sincerity and conviction, it has an enormous impact.
If you live in the UK and are interested in joining the panel, please email a brief explanation of your interest to: meduserspanel@clear-uk.org
Please do not go into great detail at this stage. Applications should be no more than 200 words. We will respond to you with a questionnaire within seven to 10 days.
Channel 4 Cannabis Programme. Irresponsible, Unethical, Misleading.
The pre-publicity for next week’s programme ‘Drugs Live: Cannabis on Trial’ has been nothing but a repeat of 1930s ‘Reefer Madness’. See ‘Jon Snow gets the inside dope on skunk’ for his commentary and a video.
It is tragic that respected journalists, Jon Snow and Matthew Paris, both of whom have been intelligent opponents of the disastrous drugs war, have been duped and manipulated into being used as sensationalist propaganda by an unscrupulous production company, Renegade Pictures. After Channel 4’s prejudicial and hate-mongering programme, Benefits Street, one would have hoped that its editors would have learned lessons and resolved to take a more responsible approach.
I have been in correspondence with Renegade Pictures, with UCL, which is responsible for ethical approval of the study and with Jon Snow. Today I have written to the Chief Executive of Channel 4.
David Abraham
Chief Executive
Channel 4
124, Horseferry Road
London
SW1P 2TX
Dear Mr Abraham,
Drugs Live: Cannabis on Trial. Due for broadcast 3rd March 2015
There are compelling reasons why you should halt the broadcast of this programme in its present form. It is grossly irresponsible, deeply unethical and highly misleading.
I write as the elected leader of more than 320,000 supporters of cannabis law reform. CLEAR represents more people than all other UK drugs policy groups combined. I have made repeated attempts to engage with the producers of this programme, Renegade Pictures, but apart from one acknowledgement my correspondence has been ignored. This is an open letter which will be published on the CLEAR website.
A comprehensive complaint will be made to OFCOM if the programme is broadcast in its present form and I am already in touch with UCL on the question of ethics. At this stage I want to draw to your attention to conclusive evidence of the unethical basis of this programme.
The study being conducted by Professors Curran and Nutt is important science. However, it is not original and the outcome is a foregone conclusion. It is well established in other research and widely understood that CBD moderates the psychoactive effects of THC.
The cannabis used in the programme is not ‘skunk’ as claimed, it is a ‘haze’ variety produced by Bedrocan BV, the Netherlands government official producer of medicinal cannabis. It is prescribed as medicine by doctors in Holland, Belgium, Italy, Germany and Canada.
I would refer you to the Netherlands Office for Medicinal Cannabis, which regulates Bedrocan products. It publishes guidelines for medical professionals which can be seen here: BEDROCAN GUIDELINES
On using a vapouriser these state:
“Inhale a few times until the desired effect is reached or until psychological side-effects occur. Wait 5-15 minutes after the first inhalation and wait between inhalations.”
If you now observe the ludicrous overdose that Jon Snow and Matthew Paris were subjected to, you will understand how gravely irresponsible is the conduct of the programme’s producers.
Aside from the impact on the individuals concerned, this programme will present a highly misleading and false impression of the use of cannabis which millions of British people participate in every day.
I urge you to take prompt action and stop the broadcast of this programme in its present form.
Kind regards,
yours sincerely,
Peter Reynolds