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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Sativex

NICE Rejects Professor Mike Barnes’ Expertise in Cannabis as Medicine for a Second Time

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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.

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The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.

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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.

Written by Peter Reynolds

July 26, 2018 at 5:57 pm

Home Office Denies FOI Request In Cover-Up Of All Information On Cannabis Production Licences

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On 6th March 2018 CLEAR submitted a Freedom of Information Request to the Home Office asking for full details of the licences accounting for the legal production of cannabis in the UK.  This arose from the story which we broke on 4th March revealing that the UK is the world’s largest producer and exporter of legal cannabis, this according to data provided to the International Narcotics Control Board (INCB) by the government.

The Home Office has refused the request.  Its grounds for refusal are that disclosure “would, or would be likely to, prejudice the commercial interests of any person or would be likely to prejudice the prevention or detection of crime“.

Presumably this means that the commercial interest of GW Pharmaceuticals and whoever else has been granted such licences would be prejudiced and that they would risk robbery or other crime at their places of business.

INCB Production of Cannabis 2015-2016

We consider this to be false and without any merit whatsoever. How would it prejudice anyone’s commercial interest?  We would not expect any detail that goes behind the licence holder’s normal commercial confidence and it must be right that the identity of those companies or individuals licenced to produce cannabis should be on the public record together with outline information about the terms of the licence – what is it for, for what period, in what quantities.  Furthermore, with the security precautions required for such a licence, any attempt at crime would be foolhardy and utterly stupid.  It would be much easier either to import or produce your own cannabis.  The sort of criminal enterprise that would be required to raid, for instance, one of GW’s grows would be on a grand scale, incredibly risky and with sentences probably higher than for production of cannabis.

Clearly, disclosure of the information around these licences could, in any case, be limited to redact any specific information which should be kept confidential

It’s quite clear that this refusal is simply an excuse, probably to cover-up not only the extent of the licences but also the basis on which they have been issued.

Of course, the Home Office has pre-empted the next step in a FOI request and states that “the public interest falls in favour” of not providing this information.  We consider this to be nonsense.  It is clear that the public interest (not just the interest of the public) is very much that the issue of such licences should be a matter of public record.  It is outrageous that this information is being kept secret.

The answer to the second part of our FOI Request provides further insight into how little trust can be placed in the Home Office and demonstrates that its answers are dishonest.  In answer to a written question in Parliament on 1st March 2018, Home Office minster Nick Hurd MP said “No licences for pharmaceutical companies to grow and process medicinal cannabis for exportation to other countries have been issued.”  However the INCB report, which information can only have come from the Home Office, shows that in 2015/16 the UK exported 2.1 tons of medical cannabis.  We asked for an explanation of how Mr Hurd’s answer is consistent with the facts reported.

Nick Hurd MP, Home Office Minister

The Home Office’s answer is that “these figures could include any plant material exported for pharmaceutical purposes or pharmaceutical products containing cannabinoids that are manufactured in the UK and exported, such as Sativex.” and that it takes ‘medicinal cannabis’ to mean “substances produced to be consumed, be that smoked or ingested in any way.”

It is clear therefore that the Home Office has given two different answers to the same question and that the answer given to the INCB is correct whereas the answer given by Mr Hurd is without doubt intended to mislead Parliament.  It also seeks falsely to create a distinction between Sativex and other forms of cannabis which is manifestly and beyond doubt another deception, based on information published by GW Pharmaceuticals which CLEAR revealed in 2016.

In summary therefore, the Home Office has refused to answer the FOI Request in relation to licensing on grounds which are entirely spurious and has demonstrated that it is actively engaged in deceiving both Parliament and the public on the export of medicinal cannabis from the UK.

Following the required procedure, we have now requested an internal review of the Home Office’s handling of the FOI Request.  We argue that: “It goes directly to the question of the massive public demand for legal access to cannabis for medical use and the total denial of this by government. This policy is itself irrational and against the public interest and the refusal to disclose the information requested is a political cover-up.”

We anticipate this will be a whitewash and further attempt at a cover-up. Thereafter we have a right to complain to the Infomation Commissioner.  At this stage we would also seek to mobilise support from MPs with an interest in this area.  Ultimately, we may be able to apply to the High Court for judical review of the Home Office’s decision and we will consider mounting a crowdfunding campaign to enable this.

This is Paul Kenward, husband of Victoria Atkins MP who is the UK drugs minister. He grows cannabis for a living.

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Mr Kenward is managing director of British Sugar which grows cannabis under contract to GW Pharmaceuticals at its 45 acre greenhouse in Wissington, Norfolk.  As confirmed by British Sugar, the cannabis is for production of Epidiolex, GW’s epilepsy medicine which is understood to be 98% cannabidiol (CBD).

British Sugar website

Epidiolex is not yet licensed as a medicine although it is currently with the FDA for US approval and the European Medicines Agency for approval within the EU including the UK.  It’s unclear how the British Sugar operation can be legal as according to the Home Office it only issues licences for research purposes.  Only after the medicine has received a marketing authorisation could it be legally grown for commercial purposes.

This is Mrs Kenward, who prefers to be known by her maiden name of Atkins, in a recorded discussion with Kevin Sabet, America’s most notorious anti-cannabis campaigner who is fighting desperately to see the wave of legalisation in the USA reversed.

Victoria Atkins MP is now a junior Home Office minister with responsibility for drugs policy.  She has spoken out forcefully against any form of legalisation or regulation of cannabis in the UK.  She also rigidly maintains the government’s line that there is ‘no therapeutic value’ in cannabis.  Of course, when it comes to her husband she takes a different view and, of course, she has authority to see licences issued entirely on her own discretion.

Ms Atkins spoke about drugs regulation in Parliament in July 2017:

“We are talking about gun-toting criminals, who think nothing of shooting each other and the people who carry their drugs for them. What on earth does my hon. Friend think their reaction will be to the idea of drugs being regulated? Does he really think that these awful people are suddenly going to become law-abiding citizens?”

Isn’t it is her husband who is exactly the person she is talking about? He seems to be doing just fine as a “law-abiding citizen”.

Together with the Home Secretary, Amber Rudd MP, other cabinet minsters, including prime minister Theresa May, who was the previous Home Secretary, Ms Atkins is running a giant cannabis cartel.  As shown by the International Narcotics Control Board, the UK is in fact the world’s largest producer, stockist and exporter of ‘legal’ medical cannabis.

UK citizens are denied any access to medical cannabis at all, except in the form of another licensed GW product known as Sativex.  However, in practice, Sativex is virtually impossible to obtain.  It is believed that about one million UK citizens use cannabis illegally for medical purposes.

No, this is not a spoof article.  This story is so incredible and outrageous that you really couldn’t make it up.  Yes, the picture of Paul Kenward is photoshopped but all these facts are easily verifiable.

Misleading Parliament Again. Victoria Atkins, The Drugs Minister With A Family Cannabis Farm.

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She’s back!  Victoria Atkins MP is again engaged in answering parliamentary questions on cannabis for the UK government.  Clearly this is wholly improper when she directly benefits from commercial production of cannabis.

Ms Atkins disappeared from public view for a few weeks after CLEAR revealed that her husband is growing 45 acres of cannabis under government licence while she argues against drugs regulation in Parliament. It was particularly notable that she was absent from the House of Commons during the recent urgent question debate on a medical cannabis licence for Alfie Dingley.  Instead, her colleague Nick Hurd MP, ostensibly the Police Minister, was required to answer a question on drugs.  Similarly, she was nowhere to be seen as Paul Flynn MP’s bill came up for debate, which sadly, as CLEAR had predicted, never took place.

It is simply extraordinary that the so-called Drugs Minister should duck and dive out of view when such issues of massive public interest hit the headlines.  She has a massive conflict of interest and it is completely unacceptable for her to continue in her present role.

Yesterday, 7th March 2018, she answered a written question from Roger Godsiff, the Labour MP for Birmingham Hall Green.

“To ask the Secretary of State for the Home Department, if she will assess the health and economic benefits of legalising cannabis for medical use.”

Ms Atkins answered:

“The World Health Organization’s Expert Committee on Drug Dependence has committed to reviewing the scheduling of cannabis under the United Nation’s 1961 Convention. This is due to consider the therapeutic use, as well as dependence and the potential to abuse constituent parts of cannabis. This is due in 2019 and we will await the outcome of this report before considering the next steps.”

This answer is at best disingenuous and misleading.  Once the full facts are understood it is clear that it is deceptive and mendacious.

British Sugar’s giant greenhouse in Wissington, Norfolk where Victoria Atkins husband, Paul Kenward, grows cannabis

Ms Atkins husband, Paul Kenward, managing director of British Sugar, grows cannabis under contract to GW Pharmaceuticals for the production of medicine.  Ms Atkins deceit is predicated on another deception promoted by the UK government that is some way or another, Sativex, GW’s cannabis medicine is not cannabis.  GW is perfectly straightforward about this.  Sativex is a whole plant cannabis extract adjusted by simple blending of two different strains to deliver 1:1 ratio of THC:CBD.  It contains all the other cannabinoids, terpenes, flavonoids and other compounds present in the plants from which it is made.  The government deception is to justify the issue of a marketing authorisation (MA) for Sativex by the Medicines and Healthcare products Regulatory Agency (MHRA) which is itself a deception.  The MA was issued on the basis that Sativex is THC and CBD alone.  The MHRA conveniently overlooks the hundreds of other ingredients and calls them “unspecified impurities”. The consequence of this is that, ludicrously, Sativex is a schedule 4 drug whilst any other form of cannabis remains schedule 1 and may not be prescribed

But the plot thickens.  The deceit goes even deeper.  It has been widely reported and British Sugar confirms that its grow is not for Sativex but for production of Epidiolex, the 98% cannabidiol (CBD) medicine that has not yet received an MA.  If, as appears certain, this is the case then the British Sugar grow is unlawful under the declared policy of the government.  Cannabis production licences (other than low-THC industrial hemp) can only be issued for “research or other special purposes“. They most certainly cannot be issued for the production of a medicine that is not yet authorised.  Even if the British Sugar cannabis is low-THC, it is definitely not an approved EU industrial hemp strain and the purpose of its production is presently unlawful.

Ms Atkins through her husband is therefore engaged in the unlawful production of cannabis and is directly engaged in misleading Parliament as to government policy, the law and the medical value of cannabis.  The World Health Organization story is a trick, a distraction, an excuse to divert Parliament from understanding the truth.

Ms Atkins conduct cannot be described in any other way except as corrupt.  She is a disgrace as a minister of the Crown, to Parliament, to her profession as a barrister, to the Conservative Party, to her constituents in Louth and Horncastle and to the United Kingdom as a whole and all of its citizens.  She is manifestly unfit for any public office.

 

The UK Is The World’s Largest Producer And Exporter Of Cannabis But Its Citizens Are Denied Any Access At All

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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?

The UK Government’s Very Last Excuse For Denying Access To Medicinal Cannabis.

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hop-cannabis-leaf
Essentially, UK government policy on cannabis hasn’t altered since 1971.  Despite the vast amount of new evidence published since then and revolutionary change, particularly on medicinal use, all across the world, successive governments have stubbornly and obstinately refused to consider any sort of reform.

It doesn’t matter which party has been in power, Conservative, Labour or the coalition, it’s a subject that ministers and MPs simply refuse to engage with.  It’s easier that way for them and be in no doubt: laziness, fear of a media backlash and deeply ingrained prejudice are the key factors in this impasse.

Grubby, Corrupt Deal Between Brown And Dacre

Grubby, Corrupt Deal Between Brown And Dacre

We had the downgrade to class C in 2003 and then back up to B in 2009 but this was a turgid and useless effort.  No notice was taken of any evidence arising from this experiment.  It was enacted to enable police to concentrate more on class A drugs and reversed based on Gordon Brown’s ‘Presbyterian conscience’ and a grubby, corrupt deal with Paul Dacre to win the Daily Mail’s political support.  In fact, use went down while cannabis was class C and back up again when it was upgraded but governments have no interest in facts or evidence on this subject, only in political expediency and spinning advantage with the media.

The clamour for medicinal access has increased enormously, just as the evidence for its safety and efficacy has become overwhelming. The UK is now virtually isolated amongst first world countries with a cruel, inhumane and anti-evidence policy which makes us a laughing stock with all who are properly informed. It’s not a laughing matter for the victims though.  For those persecuted by this nasty policy it is tears, pain, suffering, disability – all of which could be alleviated to at least some extent just by a stroke of the Home Secretary’s pen.  It is sickening that all those who have held that office over the last 45 years escape without any shame or opprobrium on their character.

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Home Secretaries Have A Lot To Answer For

CLEAR receives hundreds of letters and emails every year from people who have written to their MP about medicinal cannabis and it is astonishing that unlike almost every other policy, exactly the same words are used by all MPs. They slavishly repeat the Home Office line which is ruthlessly enforced across party lines.

There have been some subtle changes.  The marketing authorisation issued for Sativex in 2010 has led to a minor change in the tired and inaccurate line ‘there is no medicinal value in cannabis’.  It’s now become ‘there is no medicinal value in raw cannabis’.  This is scientifically and factually incorrect.  Pharmacologically, Sativex  and the ‘raw’ plants from which it is made are identical.  It is whole plant cannabis oil and its authorisation by the MHRA as an extract of THC and CBD is fundamentally dishonest.  GW Pharmaceuticals reveals it contains more than 400 molecules, the MHRA says it only contains two and “unspecified impurities”.

More recently, and in the face of an explosion of supportive evidence, another line has been added.  This states that ‘the UK has a well established process for the approval of medicines through the MHRA and that any company wishing to bring a medicinal cannabis product to market should follow this procedure.  In fact, inside sources suggest that the government is very keen to see new cannabis-based medicines approved by the MHRA.  It would take the wind out of the sails of the medical cannabis campaign

This is the very last excuse for denying access to medicinal cannabis. It is nothing but an excuse and one that is misleading and based on deception.  If we can expose how weak, inappropriate and fake it is, the government will have nowhere else to hide.

Firstly, as demonstrated with Sativex, 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.  CLEAR rejects the tired, boring theory that ‘Big Pharma’ is engaged in a massive conspiracy to deny access to cannabis and to ‘keep people ill’ so it can continue to sell its products to the NHS. The MHRA isn’t engaged in such malevolent conduct, it’s simply incapable of sativex-with-cannabis-leafproperly evaluating a whole plant extract through its existing methods.

The bright, shining truth of this, that totally demolishes the government’s position, is that in every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. 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.

Of course, there is also the ludicrous status  of cannabis as a schedule 1 drug, which prevents doctors from prescribing it.  If it was moved to schedule 2, alongside heroin and cocaine, or to schedule 4 alongside Sativex (the logical choice), doctors could be prescribing it tomorrow and high-quality, GMP and EU regulated medicinal cannabis from Bedrocan would be immediately available.

So the MHRA is the final excuse, the last obstacle to a revolution in healthcare in the UK.  We need an ‘Office of Medicinal Cannabis’ as there is in the Netherlands, or ‘Access to Cannabis for Medical Purposes Regulations’ as administered by Health Canada. Colorado has its ‘Medical Marijuana Registry Program’ and other US states have similar arrangements.  Israel’s Ministry of Health has its ‘Medical Cannabis Unit’.  In Australia, its equivalent of the MHRA, the Therapeutic Goods Administration, has established its own set of medical cannabis regulations.

This is now the most important factor in achieving medical cannabis law reform.  Next time you contact your MP or in any advocacy or campaign work you do, this is where to focus your energy.  Cannabis is a special case, it is not like other medicines.  Once we can open the eyes to this truth the path ahead will be clear.

Written by Peter Reynolds

January 31, 2017 at 11:56 am