Posts Tagged ‘medicinal cannabis’
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.
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 ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’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.
Let’s Temper Hope For Paul Flynn’s Medical Cannabis Bill With Some Reality.
Paul Flynn MP introducing his 10 Minute Rule Bill
No one would like to see Paul Flynn’s ‘Elizabeth Brice’ bill to re-legalise medical cannabis pass through Parliament more than me. Yet it concerns me that expectations are being raised way beyond what is realistic. There is widespread misunderstanding about what the bill is and what are its chances of getting any further.
The Legalisation of Cannabis (Medicinal Purposes) Bill 2017–19 is a Private Member’s Bill. It was introduced to Parliament on Tuesday 10 October 2017 under the Ten Minute Rule. This allows an MP to make his or her case for a new bill in a speech lasting up to ten minutes. An opposing speech may also be made before the House decides whether or not the bill should be introduced. If the MP is successful the bill is taken to have had its first reading.
Private Member’s Bills almost never become law. Those that have the best of a very slim chance are proposed by one of about 20 MPs who win the right to put a bill forward a bill in the ballot that takes place at the beginning of each session. This also decides the order of precedence for the 20 bills to be given parliamentary time.
A 10 Minute Rule Bill is even less likely to become law. It is the only way other than the ballot that an MP can introduce a bill personally and if it passes its first reading, as Paul Flynn’s bill did, it is set down for second reading. All Private Member’s Bills are debated on Fridays and before any 10 Minute Rule can be debated the bills put forward under the ballot will come first and even for those, mostly there will be no time available. Remember also that on Fridays most MPs will not even be in Parliament, they will be back in their constituencies seeing people in their surgeries.
Sadly, the truth is that the second reading of Paul Flynn’s bill is unlikely even to take place. Although it is set down for 23rd February 2018, there is virtually zero chance of any time being found for it. It will simply wither away with no progress or further mention.
Even Parliament’s own website says of 10 Minute Rule Bills “an opportunity for Members to voice an opinion…rather than a serious attempt to get a Bill passed.”
I asked Paul Flynn himself what he thought were the chances of his bill making any progress and his response is illuminating. His exact words were: “I am expecting major changes to political party attitudes in the next 12 months following the developing trends in the United States.”
I think we can all agree on that. In fact, I would say that there already have been major changes in the attitudes of most MPs. The single biggest obstacle to any drug law reform is Theresa May. After all, what other leader anywhere in the world, apart from the murderous thug President Durterte of the Philippines, has recently called for a continuance of the war on drugs?
May and Duterte – two of a kind on drugs policy
I am confident that once Theresa May is gone, then whatever party is in power, we will see some progress. There is similar, hopeless optimism about Jeremy Corbyn. Speaking at a Labour leadership debate in Glasgow, in August 2016, he said: “I would decriminalise medicinal uses of cannabis.” I think it was the same day or the day after that both John McDonnell and Diane Abbott contradicted him. Nevertheless, there is a delusional strand of opinion that Corbyn would act on this immediately he was elected. Dream on! The Labour Party has the worst record of any UK political party on drugs policy. For instance it was Margaret Thatcher who introduced needle exchange back in the 80s and yes, even Theresa May sanctioned the provision of foil to heroin users for smoking as an alternative to injecting. The Labour Party has never done anything in support of progressive drugs policies that it hasn’t reversed under pressure from the tabloid press.
Progress on access to medical cannabis is coming irrespective of which party is in power. In the meantime, the best that any of us can do is keep up pressure on our personal MPs and in our local media and through our doctors. Probably the biggest breakthrough this year on medical cannabis will be the publication of guidelines by the Royal College of General Practitioners (RCGP). Organised by CLEAR and authored by our Scientific and Medical Advisor, Professor Mike Barnes, this shows MPs that however irresponsible and pig-headed government ministers may be, doctors have a responsibility to their patients, an ethical duty that transcends the grubby and corrupt politics that ministers subscribe to.
Sadly then, 23rd February and the second reading of Paul Flynn’s bill will be a non-event. For the rest of 2018 look out for the RCGP guidelines and drop your MP a line when they come out asking for his or her view. Also, in July look out for Canada’s legalisation of cannabis for all adults. Again, another opportunity to bring the subject up with your MP. The latest, standard, Home Office approved reply from MPs reads as follows:
“Cannabis in its raw form is not recognised as having any medicinal purposes. The licensing regime for medicines is administered by the Medicines and Healthcare products Regulatory Agency (MHRA), which issues licences for medicines in the UK which have been tested for their safety, quality and efficacy.
A medicine derived from the cannabis plant, Sativex, has already been licenced for use in the treatment of spasticity due to multiple sclerosis (MS). The MHRA is open to considering other licence applications for medicines containing cannabinoids should such products be developed.
In 2014, the National Institute for Health and Care Excellence (NICE) published its clinical guideline on the management of MS that does not recommend Sativex as a cost effective use of NHS resources. In the absence of positive guidance from NICE, it is for commissioners to make decisions on whether to fund this treatment based on an assessment of the available evidence.
I do appreciate that there are people with chronic pain and debilitating illnesses who seek to alleviate their symptoms by using cannabis. Although such use is illicit, the Sentencing Council’s guidelines on drug offences identify such circumstances as a potential mitigating factor.
The Government has no plans to legalise the recreational use of cannabis. The official advice from the Advisory Council on the Misuse of Drugs cites medical and scientific research showing that cannabis use has a number of adverse acute and chronic health effects, especially for people with mental health problems, and continues to present a significant public health issue.”
If you receive this response, first of all, don’t bother writing back, it will get you nowhere. If you really want to do your bit then make an appointment to see your MP at his/her surgery. Then give him/her this simple fact that totally devastates the Home Office and MHRA position:
In every jurisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation.
This is the government’s very last excuse for denying access to medicinal cannabis. The MHRA process is incapable of dealing with a medicine that contains hundreds of molecules. It is designed by the pharmaceutical industry for regulating single molecule medicines, usually synthesised in a lab, which have the potential to be highly toxic. Every other government that has recognised the enormous benefit that medicinal cannabis offers has come to the same conclusion: cannabis is a special case. It is far more complex but much, much safer than pharmaceutical products.
“The Settled View Of Ministers Is That The Medicinal Campaign Is Just An Excuse To Take Cannabis”.
These are the words of Sir Oliver Letwin, my MP, during a meeting with him just a few days ago.
To some this may be an astonishing revelation, to others it will be depressing confirmation that this bigoted and out-of-date view still persists. Anyone with even a modicum of knowledge will agree that it is deeply ignorant and in defiance of a vast quantity of scientific evidence.
This is the end point of my two and half years of discussion with Sir Oliver. He’s not currently a cabinet minster but through his 20 year parliamentary career he’s always been at the top of the Conservative Party: Shadow Home Secretary, Shadow Chancellor and then in government in 2010 elevated to the status of right hand man to David Cameron. As Minister for Government Policy and then Chancellor of The Duchy of Lancaster, he was been described as ‘the intellectual powerhouse of the Tory Party’ and as ‘number three in the government after Cameron and Osborne’.
So what goes through Oliver’s mind is a pretty good indication of how the Tory Party establishment thinks. I’m absolutely certain that what he has told me is exactly the present mindset of ministers from Theresa May down.
Back in 2015 Oliver wrote to George Freeman MP on my behalf, then the minister with responsibility for medicines. He’s also written to Jeremy Hunt, the Health Secretary and Amber Rudd, the Home Secretary. None of this correspondence has resulted in anything but the usual, anodyne words that are nothing but a brush off. I did think I was getting somewhere though when he told me he would establish with the Department of Health what its position was on the scientific evidence. Back came the answer that all the evidence had been considered, expert advice had been taken and the conclusion was that the risks of legalising for medicinal use would outweigh the benefits.
Now this didn’t make sense to me. I wanted to know what evidence and what experts. After half a dozen requests for this information and no response I submitted a Freedom of Information Request to the Department of Health. Eventually it was returned stating quite clearly that it had neither requested, received nor considered any evidence on medicinal cannabis. Coincidentally, just a few days later, Paul Flynn MP asked almost exactly the same question in Parliament and received the same answer. So I wrote to Oliver and said that either he had been misled or he was misleading me, which was it? It was at this point that he stopped replying to my emails.
After several months of repeated requests and no response I went direct to his parliamentary secretary and booked a surgery appointment to see him as a constituent. I was quite prepared to confront him face to face. I was amused to receive an email from Oliver the very same day in which he said that would reluctantly agree to see me on the subject “one last time”. So at the meeting his explanation was that it had all been a huge misunderstanding, he didn’t mean to suggest that any evidence had been examined, it was simply “the settled view of ministers is that the medicinal campaign is just an excuse to take cannabis”.
Such is the state of our so-called democracy and so-called evidence-based policy.
UK Drugs Policy Equivalent To A Grenfell Tower Tragedy Every Fortnight, Yet Ministers Prescribe More Of the Same.
The scandal that is UK drugs policy deepened last month as the Home Office published what must be one of the most irresponsible government reports ever.
UK Drugs Policy Kills As Many People Every Fortnight
The 2017 Drug Strategy adds nothing of any significance to the same document published in 2010. Since then, deaths from drug overdose have reached an all time high of 2,479 (latest 2015 data). There has been an explosion in highly toxic new psychoactive substances and the Psychoactive Substances Act 2016 has increased harms, deaths, associated crime and potency, exactly as was predicted, warnings the government chose to ignore. The government has refused to consider or take any expert advice on introducing legal access to medical cannabis, something that virtually all other modern democracies are moving forward on. Its continuing policy on cannabis defies scientific evidence and real-life experience from places where reform has been implemented. It also supports and encourages the criminal market, encourages street dealing, dangerous hidden cannabis farms and the production of poor quality, low-CBD, so-called ‘skunk’ cannabis.
Do not doubt that this dreadful toll of death could be drastically reduced, at least halved, by a more responsible, progressive and evidence-based policy. We should treat those with the disease of addiction humanely, not criminalising them for their drug use, prescribing pharmaceutical heroin where necessary, introducing drug consumption rooms and giving far more weight to harm reduction rather than the unrealistic and ideological pursuit of abstinence. That would deal with the problem of drug deaths but millions more could have their lives improved, billions in public expenditure could be saved and many divisions and causes of conflict in our society could be swept away by a new approach to drugs policy in general.
Sarah Newton MP, Minister of State, during the drugs debate
The subsequent drugs debate in Parliament exposed the brazen dishonesty and deceit of Home Office ministers. The home secretary, Amber Rudd, couldn’t be bothered to show up so it was left to Sarah Newton, MP. Her performance consisted only of lies, deceit and trickery, the like of which I have rarely seen before. For many years, the Home Office has been systematically misleading and misinforming the public about drugs but here was a minister, clearly, deliberately and without compunction, misleading Parliament. As with so much of the wickedness enforced by the Home Office, Ms Newton is now beyond redemption. There can be no doubt at all about the depth of her dishonesty and the effect on the lives of millions of people should, surely, amount to a very serious crime. Its consequences are far, far more serious than the failure of national and local government that led to the Grenfell Tower tragedy but they are caused by the same mindset of arrogance, prejudice and refusal to listen to expert evidence.
If there is any reason behind what comes out of the Home Office on drugs then it is most certainly corrupt. It may not be plain brown envelopes changing hands but at best it is negligence, failure to act responsibly and in the interests of the public. This is corruption and there is no doubt it is firmly embedded amongst Home Office civil servants. Their reputation is in the gutter: other government departments, universities and research institutions, drug licence applicants and holders, politicians – they all report stubborn, intransigent, uncooperative conduct. While giving evidence to a Parliamentary Committee a year or so ago, I was nervous about how trenchant was my criticism of the Home Office. I needn’t have been. Every member of the panel nodded and agreed with me that Home Office is impossible to deal with.
Nothing can absolve ministers of their responsibility but after nearly 40 years I have seen many of them come and go while the Home Office remains exactly the same. There is a culture amongst the civil service that resists any move towards any drug reform using whatever methods it deems necessary. This is nothing less than subversion of our democracy and it is senior civil servants engaged in this treachery.
There is blood on the hands of Sarah Newton, Amber Rudd and, of course, the former home secretary, Theresa May. That’s on the top of the misery, deprivation, violence, poverty, crime and ill health that their policies cause.
Change is inevitable but only after many more have died and others have had their lives blighted or ruined by this oppressive, unjust persecution. Although the drugs debate was once again sparsely attended, it was better than the last time the subject was discussed and more MPs from all parties are at last beginning to see the light. The Labour Party remains disgraced. Its record is even worse than the Conservatives and despite some positive words from Corbyn about medicinal cannabis, this is not reflected in policy and flatly contradicted by John McDonnell. Diane Abbott, as shadow home secretary, was truly pathetic in the debate and she offered no real opposition at all to the government.
From the campaign point of view it’s very disheartening but reformers should not despair. We are making steady progress, not just among MPs but also within the media. Even the Murdoch press, the Mail and all the tabloids have changed their position. The darkest time of the night is just before dawn and I do believe that shortly we will see the first glimmers of light. We are on the cusp of change and legal access to medical cannabis will almost certainly come first.
New Drug Strategy Promises More Death, Misery And Ill Health For UK.
The long overdue update to the UK Drug Strategy is published today by the Home Office. A copy may be downloaded here.
Sadly, as expected, it is nothing except more of the same. It offers no new ideas worthy of any note and reinforces the failure of existing policy by further embedding an approach which has already been conclusively proven not to work.
The UK has become increasingly isolated in its approach to drugs policy and now that both Ireland and France are moving towards decriminalisation we are unique amongst modern democracies in maintaining an approach based on nothing but prohibition. We now stand closer to countries such as Russia, China, Indonesia and Singapore. In fact, the only thing that separates us from countries with such medieval policies is that we do not have the death penalty for drug offences. Otherwise our policy is just as repressive, anti-evidence, anti-human rights and based on prejudice rather than what is proven to work.
From Home Secretary Amber Rudd’s introduction, through sections based on repetition of the original strategy, ‘Reducing Demand, Restricting Supply and Building Recovery’, the document is more of the same old platitudes, bureaucratic doublespeak and meaningless civil service and social worker jargon. It offers nothing but despair to those wracked by addiction, desperate for the proven medical benefits of cannabis or suffering from the tremendous social problems caused by prohibition. In every respect it mirrors the government’s approach to housing which has led to mass homelessness, depravation and the Grenfell Tower disaster. It is yet another inadequate response imposed by a government which is out of touch and wedded to policies based on ideology rather than evidence.
UK Government Policy
Current UK drug policy has already led to the highest ever rate of deaths from overdose. Deaths from heroin more than doubled from 2012 to 2015, yet there is absolutely nothing offered in this document that might change this – as if existing policy is quite OK. Similarly, in what would be farcical humour were it not so tragic, the government seeks to portray the Psychoactive Substances Act 2016 as a success. It trumpets the closure of hundreds of retailers and websites and end to open sales but it doesn’t even mention the burgeoning new criminal market which has led to a massive increase in harm and products which are more potent but also more inconsistent and unpredictable. All the experts (except those appointed by the government) agree that this new law has been a disaster. Just like Grenfell Tower, this is government enforcing policies which significantly increase danger and harm without any regard at all to evidence or public opinion.
As before, this strategy doesn’t even consider harm reduction, it offers only a puritanical, moralistic approach based on abstinence. It fails entirely to recognise that 95% of all drug use is non-problematic, without causing harm to anybody. It is entirely focused on mis-use and blind to the great benefits, often therapeutic but also simply of pleasure, enjoyment and recreation that many people gain from safe drug use, just as most people do with that most dangerous drug of all, alcohol. These people, the vast majority, are completely ignored by their government.
By its own title this is a drug strategy, not a drugs strategy. It treats all drugs and all drug users the same, whether they are a prisoner serving a long sentence without access to education or rehabilitation, a ruthless gangster engaged in human trafficking, an affluent clubber, humble festival goer or a multiple sclerosis patient who grows a few cannabis plants for pain relief. It is a travesty of government, failing entirely to meet the needs of the population.
It also contains some of the most extraordinary factual errors and contradictions. “Most cannabis in the UK is imported”, it states in defiance of the evidence that the UK has been virtually self-sufficient in homegrown cannabis since the 1990s, even to the extent where we are ‘exporting’ to other European countries.
Unsurprisingly, the report states “We have no intention of decriminalising drugs” but then makes the dubious assertion that “Drugs are illegal because scientific and medical analysis has shown they are harmful to human health.” This is simply unsustainable in face of the facts about harms caused by legal substances such as alcohol, peanuts and energy drinks. It is also inconsistent with the stated purpose of the Misuse of Drugs Act 1971 which is about misuse “having harmful effects sufficient to constitute a social problem.”, nothing to do with individual health harms.
The report fails at all to consider the negative effects of current policy and how prohibition rather than drugs themselves is actually the cause of most harms connected with drugs. It doesn’t even mention the worldwide revolution in the medical use of cannabis or that one million UK citizens are criminalised and placed in danger of criminal sanctions or contaminated product simply for trying to improve their health. Neither does it mention drug testing, a proven method of reducing the harms of club drugs, now being supported by many police forces at festivals.
This report really is as empty, ineffectual and useless as anything produced by this already tired and discredited government. The parallels between Grenfell Tower and a government which actively maximise the harms of drugs through its policies are extraordinary. Thousands are dying every year because Mrs May and Mrs Rudd won’t listen to evidence. They pick and choose whether to accept the advice of their own Advisory Council based on political convenience rather than facts and while the Council includes eminent scientists it also includes specialists in ‘chocolate addiction’ and evangelical Christian ‘re-education’ of gay people.
Whether it’s determining the inflammability of building materials or the relative potential for harm of different substances, what is clear is that this government is more concerned with dogma, vested interests and old-fashioned prejudices than the safety, health and wellbeing of the population. This Drug Strategy is a recipe for failure, for continuing exactly as before.
