Archive for the ‘Health’ Category
WARNING. So-Called ‘Indica’ CBD Products Are Illegal.
Any CBD products marketed in the UK as derived from ‘indica’ cannabis are illegal and you could be prosecuted for possession, importation or supply as with any other form of prohibited cannabis.
The situation which started last October with the MHRA trying to shut down marketing of CBD products arose because of irresponsible, cowboy companies making medicinal claims about their products. It was well understood by all professional CBD companies that this would cause problems and indeed it has. Only the intervention of CLEAR and the formation of the Cannabis Trades Association UK has saved the market from collapse.
We are deeply concerned to see that at least one company is now advertising some CBD products as derived from indica cannabis grown in the Netherlands. This is unlawful. The only cannabis strains that may be grown as industrial hemp and therefore used to produce exempt products are on the EU approved list. There are no indica strains.
You have been warned. Please do not endanger yourself.
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The Facts About CBD In The UK. December 2016.
On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.
A lot has happened since. Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available. This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic. There will be some changes but no one will lose access to CBD for the foreseeable future.
Background
Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses. It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine. On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm. If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.
It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers. Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.
CLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK. The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.
On 13th October, the MHRA issued a statement on its website explaining its actions.
CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA. Even the British Medical Journal covered the story.
On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November. On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter. CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.
The meeting took place at MHRA headquarters on 3rd November. It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD. Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement. Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation. We await the MHRA’s response.
The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them. However, CTAUK has been able to negotiate that our members have until the end of January to comply. This is excellent news and demonstrates recognition of the association by the MHRA.
Is CBD Legal In The UK?
Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016. As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.
Is The MHRA Going To Ban CBD?
No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.
What Will Happen In the Future?
We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation. However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes. We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.
My 11-Year Old Dog, Capone, Is A Miracle Of Medicinal Cannabis.
Capone Stanley Reynolds, to give him his full name, has been my faithful, handsome and sweet-natured companion since 2007. He really is a lovely dog, a strong silent type, very self-contained, gentle, calm and, I believe, wise.
Sadly, he developed epilepsy around the age of five and a couple of years later was struck with severe arthritis which means for the last three years or so he hasn’t been able to walk with me as he used to. However, regular use of CBD oil has transformed his life and I think we will have several more years together before he goes to that neverending walk in the sky where he will be able to run and play as he did when he was younger.
He’s a cross between a Staffordshire Bull Terrier and a German Shorthaired Pointer – which is where he gets his gorgeous coat from, a mottled mixture of grey, black, white and a few touches of orange. I believe that, apart from his siblings, he is unique and he attracts a great deal of attention. People say he looks like a leopard and several times I have been offered large sums of money for him.
We have walked hundreds of miles together. He first came to live with me when I lived in Emsworth, Hampshire. We learned the pleasure of walking together around Chichester Harbour and I had an article about our adventures published in Country Walking magazine.
I had once before, in the late 70s, seen someone fall down on a zebra crossing while having an epileptic fit. Nothing prepares you though for when someone you love first endures a seizure. It is frightening and deeply distressing. I can only despair at what it must be like for a parent whose small child suffers so.
Quickly though, you become used to it. You have to, for your own sake and so that you can look after the one who is fitting. In fact, there’s not a lot you can do, except protect them from hurting themselves while thrashing about. Every seizure is different but for Capone they all start with the most intense rigidity, arched back, teeth clenched and violent shaking. Then, after a minute or so, he will appear to relax and his legs will start a frantic bicycling motion while he froths at the mouth and usually loses control of his bladder, weeing everywhere. Occasionally he will go back into the rigid phase but at some point, usually within three or four minutes, he will jump slightly as if he’s just woken up – and indeed he has. Then he wants to stand up, although he doesn’t have proper control of his legs and he will fall over or walk into the wall or furniture. For up to an hour afterwards he will be wide-eyed, panting crazily and usually ravenously hungry. Gradually he calms down, until at last he sleeps, exhausted.
Capone’s seizures come in clusters over a 36 to 48 hour period. To begin with it was about every three hours, so it’s utterly draining, all through the night, never more than an hour or two’s sleep before the next one starts. When at last it comes to an end, it takes three or four days for him to recover. It’s almost like he’s had a stroke and he seems stupid, off balance and doesn’t really seem to know where he is. Thankfully, he always has recovered, right back to normal again and a week later it’s all forgotten.
I can’t remember the exact sequence of events now but it was around this time that the story of Charlotte Figi became known, the remarkable effect of CBD oil on this small child with Dravet’s Syndrome, a severe form of paediatric epilepsy. It wasn’t long before I decided to try Capone on CBD.
Carla And Capone
His arthritis had also dramatically worsened by now. We went from walking five miles every day to the point where it was taking the same amount of time for him just to walk half a mile or so. Both I and my other dog, Carla, were frustrated and suffering from a lack of exercise. Eventually I had to make the heartbreaking decision to leave him at home and just Carla and I would go for a walk. With a lack of exercise he began to put on weight and it became a vicious circle. About three years ago it had reached the stage where he couldn’t walk more than about 20 yards and I feared I would have to make the toughest decision of all. In this state, when a cluster of seizures came along, he truly was a pathetic sight, my wonderful, beautiful dog and friend in so much distress and pain.
I tried various CBD products. I didn’t really know what I was doing and they didn’t seem to have much impact. But then, nothing did. The best the vet could offer was rectal tubes of diazepam, like a small toothpaste tube with a nozzle that you stick up his bum and squeeze. They had no impact at all. I have given him 30mg of diazepam while he was fitting (enough to lay me flat out for 24 hours) and it’s made absolutely no difference. But then neither did CBD. There was none of this immediate effect like you see on the many YouTube videos of children being dosed with CBD oil.
Gradually though the frequency and intensity of his seizures started to diminish. I had settled on using PlusCBD Gold oil. Two grams of this dissolved in olive or hempseed oil contains about 500mg of CBD and that would last for a month or so, giving him a dropper full every morning with his breakfast.
He was walking better. On a good day he could now manage a couple of hundred yards. In the summer he was able to do his very favourite thing and walk up the garden into full, unshaded sunlight and spend most of the day there sleeping on the lawn. The seizures seemed to have stopped.
Then, perhaps a year ago, I quadrupled his dose. I now use LoveHemp 20% oil which provides a full 2000mg of CBD. I dissolve this in
olive or hempseed oil in a 50ml dropper bottle and he continues to get one dropper full every day.
In the past two years, Capone has had just one cluster of seizures. It took place over the same period but there were far fewer fits of much less intensity, perhaps seven or eight over 48 hours. He can walk a few hundred yards now. He’ll never be the vigorous, fast-running dog he once was but occasionally I take him for a slow walk now for half an hour or so. If he sees another dog he gets excited and gets up a rather ungainly and clumsy turn of pace – but it’s almost a run and he’s still Capone and I treasure every minute that we have together. CBD oil, or as it should be more accurately termed, low-THC whole plant cannabis extract, has saved his life.
Crispin Blunt Asks Parliamentary Question On Medicinal Cannabis, 22nd November 2016.
Crispin Blunt MP
Q. To ask the Secretary of State for Health, whether (a) his Department and (b) the Medicine and Healthcare Products Regulatory Agency has reviewed the latest evidence, including evidence on different regulatory approaches in other jurisdictions, for the use of medical cannabis.
Nicola Blackwood MP. Minister Of State For Health
A. The Medicines and Healthcare products Regulatory Agency (MHRA) reviews evidence submitted by a company seeking a marketing authorisation for a medicinal product in the United Kingdom. One product containing extracts of cannabis, Sativex, has been licensed as a medicinal product by the MHRA. However, no such application has been received in respect of herbal cannabis, and therefore the MHRA has undertaken no review of the evidence for its medicinal use. Outwith the MHRA licensing process, the Department has not conducted or commissioned a review of herbal cannabis or its regulation in other jurisdictions.
Breakfast Of Champions 3.
This is the classic breakfast for me. It’s essential to serve it with HP sauce, genuine HP sauce (I know of no acceptable own brand substitutes).
Split, season and bake large tomatoes at about 150 C for about 20 mins. It has to be smoked bacon for me, fried until it just starts to go crispy in some places. Serve on thick, buttered, granary toast.
Tip. You don’t get what you pay for with bacon, particularly not in supermarkets. Those expensive, flat trays where six rashers of bacon are artfully displayed alongside various logos, brands and quality claims are mainly a rip off. A proper butcher is of course best and sliced thickly but I use Sainsbury’s value brand, smoked back bacon. It’s excellent value and very tasty.
Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.
Unsurprisingly perhaps, the response to the recent call from MPs and peers to legalise cannabis for medicinal use has come straight from the top. Theresa May’s longstanding reputation as a denier of science and evidence on drugs policy is reinforced by her peremptory dismissal of the expert report. It seems that, at least in the short term, the UK government is sticking by a policy that is discredited, ridiculous and deeply cruel.
It fell to Sarah Newton MP, minister of state at the Home Office, to respond to a parliamentary question from Roger Godsiff, Labour MP for Birmingham, Hall Green.
Roger Godsiff MP
“To ask the Secretary of State for the Home Department, if she will respond to the recommendations of the report by the All-Party Parliamentary Group for Drug Policy Reform Accessing Medicinal Cannabis: Meeting Patients’ Needs, published in September 2016.”
Sarah Newton MP
“The Prime Minister responded to the All-Party Parliamentary Group for Drug Policy Reform’s report ‘Accessing Medicinal Cannabis: Meeting Patients’ Needs’ on the 27 October.
Cannabis is controlled as a Class B drug under the Misuse of Drugs Act 1971 and, in its raw form, currently has no recognised medicinal benefits in the UK. It is therefore listed as a Schedule 1 drug under the Misuse of Drugs Regulations 2001.
It is important that all medicines containing controlled drugs are thoroughly trialled to ensure they meet rigorous standards so that doctors and patients are sure of their efficacy and safety. To do otherwise for cannabis would amount to a circumvention of the clearly established and necessary regime for approving medicines in the UK.”
In other words, this is nothing more than a re-statement of the same position that the UK government has held since 1971 when legal access to medicinal cannabis was halted. Quite clearly the government has given no consideration at all to the vast amount of scientific evidence and international experience that has accumulated over the last 45 years. The latest report which took nine months to produce, took evidence from over 600 witnesses and included a review of over 20,000 scientific studies is simply cast aside. To be honest, I doubt whether it has even been read by Ms May or anyone in the Home Office or Department of Health. This is the standard that now prevails in the UK – government of the people by an unaccountable, out-of-touch, unresponsive cabal of individuals elected by a deeply flawed system that gives democracy a bad name.
On the face of it, the claim that all medicines must be thoroughly trialled seems plausible – but it is not. It is a misleading half-truth clearly intended to squash the call for access to medicinal cannabis by painting a false picture.
Doctors are allowed to prescribe any medicine, licensed or unlicensed, as they see fit, based on their own judgement. But prescribing of cannabis is specifically prohibited by Statutory Instrument despite the scientific consensus that it is far less dangerous than many, probably most commonly prescribed medicines.
So it’s not a level playing field. It’s a policy that is based on prejudice and scaremongering about recreational use of cannabis. Ms Newton’s answer is at best disingenuous but then she probably doesn’t even realise that herself. For many years Home Office policy has been systematically to mislead and misinform on cannabis and evidently under Ms May’s successor, Amber Rudd MP, such dishonesty continues.
Theresa May MP
Something will eventually force the government’s hand to change its absurd position on cannabis. Sadly the very last consideration will be scientific evidence or the will of the people. Such factors hold no sway with UK governments. Only when enough of the political elite open their eyes and examine their conscience, or some key individuals or their family members, experience the need for medicinal cannabis will change become possible. Alternatively, political upheaval may present an opportunity. The Liberal Democrats were too cowardly, weak and concerned with building their personal careers when in coalition to advance the cause they now so bravely advocate. Perhaps the SNP, with 56 MPs, all in favour of medicinal cannabis may be our best hope.
Sarah Newton is merely a puppet of the Home Office bureaucracy. Theresa May’s mendacious position on all aspects of drugs policy is well established and she is as stubborn and bigoted as they come on such matters. Only when she, in person, is subject to sufficient pressure will this cruel, ignorant and hateful policy change.
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.
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
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.
Peter Reynolds 