Guidelines On Cannabis For Medical Professionals.
In a new initiative, CLEAR’s scientific and medical advisor, Professor Mike Barnes, has written to the presidents of several Royal Colleges proposing the development of guidelines around the use of cannabis as medicine.
Professor Mike Barnes
This is a tricky situation for doctors. Surveys and individual reports from CLEAR members indicate that many doctors tacitly endorse their patients’ use of cannabis but clearly cannot recommend the illegal use of cannabis, however safe and effective it may be.
Professor Barnes’ letter refers to the recent APPG report, his own paper ‘Cannabis: The Evidence for Medical Use’ and says:
“…cannabis now has a reasonable evidence base for the management of chronic pain, including neuropathic pain, and the management of spasticity as well as in the management of anxiety and a use in nausea and vomiting in the context of chemotherapy.”
In conjunction with CLEAR, Professor Barnes has written to:
Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of Paediatrics and Child Health
Royal College of Physicians
Royal College of Psychiatrists
His letter goes on to explain that about one million people are using cannabis as medicine:
“I do feel that doctors need guidelines to assist them when patients request advice on the use of cannabis…doctors should be properly informed about harm reduction advice and should be aware of the clinical evidence that is now guiding medicinal use in several other countries around the world.”
Our proposal is for an initial meeting to discuss the idea. If one or more of the Royal Colleges is prepared to back this initiative, CLEAR will set up and fund a working group of clinicians and medical education specialists to develop a set of guidelines.
Wise Words From Trump Supporters?
Some thoughts here that chitter-chattering, Remoaners, Remaniacs, the soft left and particularly the illiberal, anti-democratic LibDems would do well to consider.
How did this happen you ask?
You created “us” when you attacked our freedom of speech.
You created “us” when you attacked our right to bear arms.
You created “us” when you attacked our Christian beliefs.
You created “us” when you constantly referred to us as racists.
You created “us” when you constantly called us xenophobic.
You created “us” when you told us to get on board or get out of the way.
You created “us” when you forced us to buy health care and then financially penalized us for not participating.
You created “us” when you allowed our jobs to continue to leave our country.
You created “us” when you attacked our flag.
You created “us” when you confused women’s rights with feminism.
You created “us” when you began to emasculate men.
You created “us” when you decided to make our children soft.
You created “us” when you decided to vote for progressive ideals.
You created “us” when you attacked our way of life.
You created “us” when you decided to let our government get out of control.
“You” created “us” the silent majority.
And we became fed up and we pushed back and spoke up.
And we did it with ballots, not bullets.
I Am Not A Badge Of Honour.
I am not a badge of honour,
I am not a racist smear,
I am not a fashion statement,
To be worn but once a year,
I am not glorification
Of conflict or of war.
I am not a paper ornament
A token,
I am more.
I am a loving memory,
Of a father or a son,
A permanent reminder
Of each and every one.
I’m paper or enamel
I’m old or shining new,
I’m a way of saying thank you,
To every one of you.
I am a simple poppy
A Reminder to you all,
That courage faith and honour,
Will stand where heroes fall.
Achievement Against All Odds.
I am the most fortunate of fathers. I could never have dreamed that my children would scale such heights. A fortnight ago my youngest son, Evan, qualified as a chartered surveyor. Today my eldest, Richard, capped his extraordinary achievement in becoming a barrister by gaining tenancy at 9, Bedford Row, possibly the top international criminal and human rights set in London.
In the 21st century, the route to success as a barrister is almost impossible to negotiate but Richard has done so despite many disadvantages and challenges.
Born five weeks premature, he spent his first days of life in the special care baby unit. Twice-butchered, traumatised before the age of three in what should have been a minor operation at the Royal Surrey Hospital, he was at last properly served by a skilled surgeon at Great Ormond Street. Then, at the age of four, he was diagnosed with type one diabetes. His response, even as a small child, was to become an expert. Before he was a teenager he could have taken on any doctor, any diabetician, any endocrinologist and taught them a thing or two. His whole life is characterised by determination and an ability to gain knowledge through intense study and the application of his most remarkable intelligence.
As a child, he was known in our wider family as ‘the next prime minster but six’. I still have no doubt that he could achieve that if he put his mind to it – and he still may. He was individual national champion in the ‘Debating Matters’ competition and then, despite dyslexia, diabetes and far from the finest secondary education, he made his way to the University of East Anglia to study politics, philosophy and economics, that degree most favoured by our leaders and the elite. In truth, he neglected his studies for student politics, editing ‘Concrete’, the university newspaper and then launching a rival, Norwich-wide student magazine. Despite this he gained the requisite 2:1 and was by that time set on a career in the law.
Unlike many of his contemporaries at the bar, there was no silver spoon for Richard. His mother’s hard work, the support of his grandparents and his own diligence at some depressing jobs enabled his second degree in the law and successful completion of the bar course. To see him called at Middle Temple in October 2014 was then the proudest moment of my life, particularly as it was the very last such occasion for my father, himself a retired lawyer, before he died on the last day of that year. I believe Richard knows what supreme joy he brought to his grandfather in those last weeks of his life.
The next stage in a barrister’s career is to gain pupillage, the essential apprenticeship that leads to a practising certificate. Fewer than one in ten who are called to the bar achieve this and often they are aided by family contacts, networks, their Oxbridge or public school connections. Richard had none of this, only his ability, courage and a focus which makes determination an inadequate word to describe him.
I am very grateful that 9, Bedford Row granted Richard pupillage and has now given him the opportunity to reach the very top in his chosen profession. In the year before he began pupillage he showed how much the open market already values him and was appointed General Counsel on a fat salary at TES Global, the world’s leading educational publisher.
I am in awe of my son. He humbles me with his achievements. I have no doubt that he will take silk, become a judge, or triumph at whatever challenges he chooses. I am the proudest father.
CLEAR Statement Concerning Cannabis Legalisation Measures In US Election.
“This is marvellous news for liberty, health and human rights. The USA, unlike Britain, has a functioning democracy where the will of the people prevails rather than the bigotry and self-interest of politicians. It is wonderful to see that truth, justice and evidence is winning out over the lies and misinformation we have been fed about cannabis for almost 100 years.
In 1971, the British government abdicated all responsibility on cannabis and abandoned our communities and our children to criminal gangs. Since then all the harms have multiplied exponentially. The laws against cannabis fund organised crime, promote dangerous hidden farms which are fire risks, the destruction of rental property, selling to children, contaminated ‘moonshine’ cannabis, gang violence, lives ruined by criminal records and the cruel denial of safe, effective medicine that can relieve pain, suffering and disability.
Donald Trump has supported access to medicinal cannabis all along. Many British politicians who consider him to be an unreasonable person should now look to themselves and ask whether they are being reasonable by supporting prohibition, even for medical use.
It is time for Theresa May, Amber Rudd and the UK government to take responsibility for the £6 billion pa cannabis market. The tide of legalisation is now unstoppable and it would be deeply irresponsible for them to fail to act. They must grasp this nettle now!”
Peter Reynolds, president of CLEAR Cannabis Law Reform
CLEAR Cannabis Law Reform Accounts 2015.
Income
Compared to the previous year, CLEAR’s regular income in 2015 was up 79% to £17,074. The majority of income continues to come from memberships, with the remainder coming from donations, merchandise and Google advertising.
Regular income: £17,074
Expenditure
CLEAR spent a total of £12,023, a decrease of 11% on the previous year.
Total expenditure: £12,023
Administration: membership administration, stationery, postage, telephone & internet, meeting expenses, etc. Administration costs have increased as an overall proportion of expenditure as there were no dedicated campaigns during the year.
Travel: expenses incurred meeting government ministers, MPs, agency representatives, media engagements, boards meetings, also re-imbursement of travel costs for Medicinal Use Panel members
Fundraising costs: PayPal fees and other fundraising costs
Promotion: Facebook advertising, printing of leaflets, design work, etc.
Breakfast Of Champions 2.
A recent invention of mine.
Bake the black pudding at about 150 C for about 10 minutes. Chop roughly and fry in butter for a few moments in the omelette pan to give crispy edges. Add as many well-seasoned, beaten eggs as you wish and cook for a couple of minutes. You can fold it or serve it flat and cut into sections.
Remember to give the dogs a little taste, it’s only fair.
Tip. Please keep the inside of the omelette as runny as you can, it makes all the difference. After decades of experience as a black pudding connoisseur, I buy mine from Framptons of Bridport. It’s described as ‘local’ but it isn’t that local because it’s made in Poole – but it is the business!
Report Of Meeting With MHRA On Regulation of Cannabidiol (CBD).
Tom Whettem, Canabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development
Yesterday, 3rd November 2016, six delegates from the UK Cannabis Trade Association (UKCTA) met with Medicines and Health Products Regulatory Agency (MHRA) representatives at the agency’s headquarters in Victoria.
We were courteously received. The meeting was cordial, productive and enabled both sides to clarify their positions and better understand each other’s perspective.
In summary, in my opinion, there is no immediate threat to to CBD consumers or businesses. The MHRA has now extended until 31 December 2016 the date by which businesses should voluntarily comply with its opinion, either by withdrawing existing products from the market, or by complying with necessary regulation. Thereafter, the next step would be to begin the process of statutory enforcement. This would take a matter of some months and I believe, even were this to be started, we are looking at more than a year before any impact would be felt. More importantly, based on the meeting, I think the outcome is likely to be that we can negotiate a form of regulation that will work for everyone.
The MHRA team was led by Gerald Heddell, Director of Inspection, Enforcement and Standards. Also present were regulatory advisors David Olszowska and Chris Groutides; Dr Chris Jones, Manager of the Medicines Borderline Section; Greg Markey, Senior Medical Assessor and Malcolm Evans, Head of Patient, Public and Stakeholder Engagement. Mr Heddell opened the meeting by thanking us for bringing to the agency’s attention just how many people are using CBD, some for quite serious medical conditions.
The MHRA set out its reasons for its opinion that products containing CBD used for medical purposes are medicines. Greg Markey explained the mechanisms of action and pharmacology that had been considered and Dr Jones explained that the Borderline Section existed to deal specifically with products where it was difficult to determine whether they should be regarded as medicines or food supplements. The example was offered of vitamin C where if it was being used to treat scurvy then it was clearly a medicine, whereas if it was used to supplement a normal diet it could be regarded as a food supplement. We were able to explain that all so-called CBD products on the market, with the exception of crystals, are actually whole plant extracts from low-THC cannabis, usually industrial hemp. We pointed out that the growth in the CBD market had been driven by people seeking the therapeutic benefits of medicinal cannabis which until now had been denied by the British government.
The nub of the issue is really the nature of the condition for which CBD is used. The MHRA has already issued orphan designations for CBD for Dravet Syndrome, graft versus host disease and perinatal asphyxia. Orphan designations are granted where the benefit of a medicine can be recognised even though necessary regulatory processes have not yet been completed. It is important to understand that this is what has guided the MHRA’s opinion, viewing CBD as a medicine for very serious conditions.
We discussed a range of options whereby, at the lowest level, CBD products could continue to be marketed as a food supplement. For minor conditions, not requiring medical supervision, it may be possible to obtain a Traditional Herbal Registration (THR) at a cost of a few hundred pounds. A third option is a ‘Specials’ exemption where a doctor or prescriber has specified and taken responsibility for an unlicensed medicine for a particular patient. Finally, the highest level is a Marketing Authorisation (MA) where the costs including fees and clinical trials are probably a minimum of £250,000.
It is our view that CBD products should be regulated at all these different levels dependent on the purpose for which they are used and the concentration at which CBD is present. We have agreed that we will write formally setting out these proposals and the MHRA will respond accordingly.
The UKCTA and a number of individual companies have now obtained legal advice including counsel’s opinion. We have shared this with the MHRA and formal solicitors letters have already been served. In essence, the advice is that the MHRA has failed to comply with its own guidelines and requirements in issuing its opinion to CBD suppliers and that any requirement to comply with regulations would have to be addressed on an individual, product by product basis.
So, all in all, we believe the meeting was a success. We demonstrated that the new trade association is to be taken seriously and that we will work constructively with the agency. There was visible surprise at the level of professionalism we presented, particularly with the legal advice we had obtained. I believe we convinced the MHRA that we could establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements.
The CBD market in the UK is presently worth several million pounds a year. If it is to continue to grow, provide safe, effective products for consumers and patients and job security for its workers, then we need to establish UKCTA so that it effectively represents the whole industry. We need to show that we are responsible, we care, we are professionals and we are ready to put our collective head above the parapet as a legal, ethical and regulated industry.
Breakfast Of Champions.
I decided I deserved a treat this morning.
Kippers pan-fried in butter and a touch of olive oil, two very soft poached eggs, served with hot, buttered, granary toast and strong tea. The dogs get a mouthful each and then are allowed to clean the plate and the pan.
Bliss.
Tip. Choose your kippers wisely, buy them from a proper fishmonger and season generously with black pepper.
MHRA Backtracking Super Fast On CBD Ban.
In advance of the meeting between the UK Cannabis Trade Association (UKCTA) and the MHRA on Thursday, there has been a flurry of activity which amounts to a climb down by the regulator.
This statement was published on the MHRA website at lunchtime today.
“Update 1 November 2016
An MHRA spokesperson said:
While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
Originally the MHRA wrote to CBD suppliers in threatening terms:
“You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
So quite a change in tone. The MHRA seems to have recognised that contrary to its declared mission ‘to improve health’, its original statement actually endangered the health of tens of thousands of people.
Additionally, solicitors representing the UKCTA have now written to the MHRA seeking clarification of its intentions and making three crucial points:
- The letters to CBD suppliers and the MHRA’s original press statement have caused serious financial damage to the CBD industry.
- The MHRA has conducted no effective consultation with stakeholders.
- The MHRA’s own guidelines require it to consider each product on a case by case basis and a blanket ban on products containing CBD would be unlawful.
Professor Mike Barnes
Professor Mike Barnes, scientific and medical advisor to CLEAR, commented:
“The MHRA’s new stance is an improvement from their previous position. However, I cannot see any value in delaying only a few months. Some patients might be able to find an alternative medicine from their doctor but many people will have already tried alternative medications and found that CBD is the only satisfactory treatment for their condition. This is the case, for example, for children with epilepsy who will have almost certainly have been under the care of a specialist and tried available anticonvulsants and found that CBD is the only treatment that works for them. The MHRA does not seem to realise the impact of this arbitrary and rushed decision which will clearly be detrimental and potentially have very serious (and in some cases life threatening) implications for some people. The MHRA need to work with the manufacturers and the medical profession to determine the best way forward that both recognises that cannabis based products have medicinal value, and as such need proper trials of efficacy and safety, yet on the other hand does not place existing users at risk of harm”.
Peter Reynolds 