Posts Tagged ‘National Institute for Health and Care Excellence’
Still ‘Insufficient Evidence’ for the NHS to Fund Medicinal Cannabis – or What’s it Really About?
The laboratory evidence for medicinal cannabis is through the roof in proof of efficacy and safety. The observational clinical evidence is also conclusive.
The evidence that is ‘lacking’ is that which fits in with the medical establishment’s well-established formula for making senior clinicians rich. The same doctors that write the guidelines are the ones who earn the very fat fees for running clinical trials and decide which evidence is valid and which isn’t. When the Royal Colleges and the professional medical bodies have worked out a way to get cannabis under their control, suddenly all the evidence will be OK. Then the committees and advisory boards that these same doctors sit on will turn on the NHS funding tap.
Until then, doctors are frightened of cannabis. A medicine that works, that is safer than virtually all the pills you can buy over-the-counter and has powerful, beneficial effects for a very wide range of conditions is a real threat to vested interests and doctors’ status. It shakes their world and so they are eager to disparage it, exaggerate its risks and diminish its efficacy.
Only when the medical establishment understands how its pre-eminence is going to be maintained, knows where fees and prestige are coming from, then cannabis will be ‘discovered’ by the NHS and all the benefits to patients and in reduced costs will follow.
NICE’s Draft Guidelines on Cannabis Prove That Its Methods Don’t Work and It Is Causing Harm to Patients
The draft guidelines produced by the NICE committee are nothing short of ridiculous. There is a complete absence of common sense and an absurd failure properly to consider all the available evidence.
But it’s actually much more serious than this. It is now abundantly clear that this committee, its membership and its conclusions were only ever intended to delay, obfuscate and sabotage the reforms which were introduced in November last year because of a public outcry.
The selection of members of the committee is by any standards corrupt. The most highly qualified people have been deliberately excluded. Anyone publicly expressing support for the use of cannabis as medicine has been rejected whereas those selected have frequently expressed opposition. The inclusion of the ‘reefer madness’ advocate Professor Finbar O’Callaghan is both reprehensible and inexcusable. If the man had any ethical standards or conscience he would recuse hismself. The committee is a confidence trick.
The medical establishment, the Home Office and all the various regulators, including the MHRA, the FSA and the Royal Colleges are all institutionally opposed to cannabis and they are doing everything they can to stop it reaching the people who can benefit from it. Cannabis, the more intelligent approach to medicine it both requires and inspires, threatens too many vested interests and the comfortable, self-satisfied and self-serving model of healthcare that prevails in Britain.
But if any NICE apparatchik or fat cat pharma supremo thinks they can stop cannabis they are fooling themselves. From right around the world the overwhelming weight of expert opinion and patient experience reveals that what is happening in Britain is merely delaying the inevitable. But in the meantime it is causing great suffering and unnecessary harm to patients. It is a scandal of the highest order and the people responsible for it must be called to account.
CLEAR has responded to the consultation on the draft guidelines in great detail. Without reproducing our line by line commentary, these are our three general observations.
1. The entire guideline is characterised by a failure to consider observational evidence and real-world experience. Cannabis is the oldest medicine known to mankind and failure to give substantial weight to real-world experience of its safety and efficacy is nothing short of absurd. Given its illegality over the past 100 years, the wild scaremongering about its recreational use and therefore the lack of formal clinical evidence, this is simply setting it up to fail. It is irresponsible in the extreme to fail to consider the enormous benefit at very low cost and the very few adverse events associated with illicit cannabis.
2. There is little evidence of potential for harm for cannabis for any medical condition. Given the enormous numbers using cannabis in its most potent form as a recreational drug and/or self-medicating (estimated at 250 million regular users worldwide) there are far fewer adverse events or incidents of harm than for common over-the-counter medicines.
3. The weight given throughout the guideline to the potential for harm of cannabis is wildly disproportionate. There is no evidence of any significant harm from cannabis when used as a medicine, especially when under the supervision of a medical professional. At least 10,000 years of human experience shows that cannabis is essentially safe. Seeking to evaluate its safety in the same way as a new, experimental medicine, synthesised in a lab for which there is no real-world experience is a fundamentally flawed approach. Unlike potentially dangerous or unsafe medicines, cannabis can and should be offered to patients on a ‘try it and see’ basis. Instead of being over-cautious, clinicians should welcome this approach and can be certain that it will benefit patients whether or not in proves effective in individual cases.
NICE Rejects Professor Mike Barnes’ Expertise in Cannabis as Medicine for a Second Time
Professor Mike Barnes is without doubt the UK clinician with the most expertise in the use of cannabis as medicine. He should have been first choice as a member of the NICE committee charged with developing cannabis prescribing guidelines and, as reported here, its rejection of his application was greeted with astonishment. However, NICE relented and invited Professor Barnes to an interview. Now they have rejected him again.
Mike was responsible for obtaining the first medicinal cannabis licences for Sophia Gibson and Alfie Dingley and he has been involved in countless behind-the-scenes efforts to assist others. He joined the advisory board of CLEAR in July 2016, is an ambassador for the End Our Pain campaign and has since contributed his expertise to several other organisations including UPA. He is also founder and director of education at the Academy of Medical Cannabis and founder of the Medical Cannabis Clinicians Society.
What concerned NICE in the first place was that in February 2018, Professor Barnes was appointed Chief Medical Officer of SOL Global Investments (known as Scythian Biosciences until June 2018). NICE was concerned this could be a conflict of interest. In fact, SOL is an international cannabis company with a focus on legal U.S. states. It has no investments or plans for the UK. When Mike told NICE this he was invited for an interview. The second letter of rejection reads:
“It was clear that you have relevant experience and expertise in this area however the interview panel remained concerned about possible conflicts of interest around your links to commercial organisations and your campaign work in the area which means that you have a publicly stated position on the topic.”
Few will regard that as a credible or logical reason for not having Mike on the committee. It’s actually absurd and really makes one wonder who makes these decisions and what planet they are on. If there were even a few alternative candidates to consider then it might make some sense but there don’t appear to be any alternatives to Mike Barnes. If there is anyone else in the UK with his clinical qualifications, knowledge, experience and expertise, no one at CLEAR has heard of them. It’s foolish and irresponsible to reject the only real source of knowledge that will command respect from other clinicians and for such very flimsy and poorly thought through reasons.
How many other clinicians on other NICE committees have commercial relationships with pharmaceutical companies or other medical organisations? How many have also expressed their professional or personal opinions on matters of medical policy and practice? Have they been disqualified for the cardinal sin of holding an opinion? Does NICE want people on this committee who are insufficiently informed or so shy that they do not express opinions?
Could this happen anywhere but in Britain? However patriotic and loyal one is to our country, this sort of crass stupidity and hypocrisy seems to be a special gift of the UK civil service.
NICE has Form for this Sort of Self-Defeating Bureaucracy
Its ‘Do Not Do Recommendation’ on Sativex is directly relevant and is based on on a flawed assessment of cost effectiveness which itself is founded on ignorance of the way cannabis works and a determination not to give proper weight to MS patient reports of the benefit they gain from Sativex. None of this is to overlook the unethical and profiteering price which GW Pharmaceuticals wants to charge for the medicine. Pharmacologically identical products are available from US and Canadian medical cannabis dispensaries for about one-tenth the price of Sativex.
NICE has also failed dismally on the Freestyle Libre glucose monitoring system for diabetics. This revolutionary new system not only makes life much easier for thousands of people, doing away with the need for endless finger pricking, it also dramatically improves blood sugar control promising huge reductions in the long term cost of diabetes to the NHS. It’s been available since 2014 and thankfully will now be prescribed on the NHS from April 2019 but for five years NICE has dithered, waffled and procrastinated on it, exactly as it is now doing with cannabis. Until now, just as with cannabis, it has claimed insufficient evidence but the real problem is NICE has a blinkered view and fails to look widely enough for the evidence it requires.
In a remarkable parallel with the way it is handling cannabis, NICE claimed there was no evidence that the Freestyle Libre led to better blood sugar control in type 1 diabetics, But the reason it claimed this was that there was no study supporting it that met NICE’s criteria and by impeding uptake of the device it was making such a study virtually impossible. NICE totally failed to give any weight to the many case reports of really dramatic benefits – exactly as it is doing with cannabis.
So, while our prime minister and the Home Office drugs minister have a direct financial interest in the UK’s only commercial producer of medicinal cannabis, yet direct and control drugs policy, when it comes to caring for patients, the only British clinician with relevant expertise is disqualified by a connection with an overseas cannabis company and for expressing an opinion than cannabis could help many people.
As a footnote, I should declare that I also volunteered to give my time to the NICE committee as a lay member and I too was rejected. It’s not for me to question its judgement unless I have good reason to but given its track record with Mike Barnes, I do have legitmate concerns. I first gave expert evidence to Parliament on the subject in 1983 and again in 2012 and 2016. Since 2011 I have worked intensively with hundreds of people who use cannabis as medicine and I lead the group that represents more such people than all other UK groups combined. I am also the author of the study Medicinal Cannabis: The Evidence, which has been translated into three languages and has been cited many times throughout the world. I know of no one in the UK with more relevant experience than me.
The UK Is The World’s Largest Producer And Exporter Of Cannabis But Its Citizens Are Denied Any Access At All
This is the astonishing fact revealed by the International Narcotics Control Board (INCB) in its 2017 report on narcotic drugs.
In the UK no one has any legal access to any form of cannabis except exempt products derived from industrial hemp, most commonly CBD oil.
Theoretically, the cannabis medicine Sativex is available but in practice, in England it is virtually impossible to obtain it except on a private prescription as the National Institute for Health and Care Excellence (NICE) has recommended that it is not cost effective. In Wales it is available on prescription but doctors are first required to try highly toxic and dangerous drugs such as baclofen, tizanidine, gabapentin, pregabalin, even botulinum toxin or opioids.
The reality is that UK citizens are denied access even though their country is producing and exporting vastly more cannabis even than countries such as the USA, Canada, Israel, the Netherlands and Italy, all of which have legitimate and well regulated medical cannabis provision.
This revelation will further inflame the sense of righteous injustice in the UK. Against this background the UK continues to prohibit even medical use and is stubborn and intransigent in even being prepared to consider or discuss the evidence in favour.
How can the country which sanctions the legitimate production of more medical cannabis than any other in the world deny its own citizens legitimate access?
Peter Reynolds 