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Peter Reynolds

The life and times of Peter Reynolds

Archive for the ‘Politics’ Category

If The UK Government Refuses To Obey Parliament There Is No Longer Any Rule Of Law. Do As You Will.

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The corruption and arrogance of Theresa May, her ministers, her government and the Conservative Party cannot be more clearly demonstrated than in their refusal to comply with the Parliamentary resolution to publish the legal advice on Brexit.

Parliament is supreme.  It is also the highest court in the land, higher even than the Supreme Court. Its will is the law.

And if the deeply corrupt Theresa May pursues this path, the rule of law no longer applies in the UK.  In which case, do as you will. I urge you however to continue to comply with common law and natural justice.  Do nothing that harms or infringes the rights of anyone else.

The most obvious example is grow your own cannabis.  If Theresa May doesn’t want to obey Parliament, there’s no reason why you should either.

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Written by Peter Reynolds

December 4, 2018 at 12:13 pm

Total Defeat and Humilation of Britain By the EU, Plotted By A Treasonous PM and Gang of Remainers

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The British electorate has been betrayed by a devious conspiracy of the political establishment. What we voted for has been denied and Theresa May has subverted what was already a poor excuse for a democracy. Beyond doubt she is a traitor, as with propaganda that we have paid for, fake negotiations and an incompetent opposition she has given away everything that Britain stood for.

This is the time to overthrow the government. A century and more ago this would have been by violent revolution but in our pampered, all-too-comfortable world, our corrupt politicians know that will not happen and in the surveillance state that is modern Britain, the authoritarians that rule over us would never let it.

On the wall of my office, over my left shoulder, is that wonderful war time poster of RAF airmen and Churchill’s famous quote “Never was so much owed by so many to to so few.” Truly, Theresa May and her government have thrown that all away.  We are disgraced and shamed, our leading role in history reversed by small-minded, self-serving bureaucracts.

Our only hope now is that Parliament will overturn this shambles and that we will exit with no deal. I accept that this will be chaotic and may cause all of us great problems but the alternative, to continue with Mrs May’s scheme would be disastrous.  She must be removed from office and although it’s an impossible fantasy, she should go directly to jail.

Written by Peter Reynolds

November 25, 2018 at 10:02 am

Posted in Politics

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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.

Will I Be Able To Get Cannabis Prescribed On The NHS?

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With the publication of new regulations yesterday, it is now clear how cannabis will be available on the NHS starting on 1st November 2018.

Only consultants will be able to prescribe cannabis and it will be entirely up to each consultant to make a decision about individual patients.  The definition of cannabis-derived medicinal products is sufficently wide that both oils and herbal cannabis manufactured to GMP (Good Manufacturing Practice) standards will be available.

There is very little explanation included in the regulations but the intention is that prescribing guidance will be developed over time by NICE (National Institute for Health and Care Excellence).  The regulations prohibit smoking cannabis for medical use but if your consultant decides it is appropriate for you, they will be able to prescribe herbal cannabis for vaping.  Apart from Sativex, all cannabis products are unlicensed medicines described as ‘specials’, so your consultant is supposed to consider licensed medicines first.

There are no restrictions on which conditions cannabis can be prescribed for. Again, it will be up to your consultant to decide.

So this is marvellous news.  It is a fundamental breakthrough and its impact will be enormous but it will take time for it to start working effectively.

The law is no longer an obstacle.  The biggest problem now is that very few consultants have any knowledge of cannabis at all and most are probably going to be very reluctant to prescribe.  For the best part of a century, doctors, just like the rest of society, have been subject to a relentless flow of propaganda and false information about cannabis.  Changing this with medical training, helpful prescribing guidelines and overcoming unjustified prejudice and fear are the new challenges we face.

To begin with, a lot of people will be disappointed because their consultant will be unwilling to prescribe.  The first thing you can do about this is ask your GP to refer you to a different consultant but it may be some time before understanding develops and consultants are sufficiently informed.  Almost certainly there will be more resistance to prescribing herbal cannabis and it will be easier to get oil.

As ever, the best thing to do is gather evidence on the use of cannabis for your condition(s).  If you are well informed and prepared then you can help to educate your consultant.  There is now an enormous amount of evidence available online.  Just be careful to use proper scientific information and avoid the miracle cures and exaggeration that is still widespread.

Whilst not everyone will immediately be able to get the medicine they need, we are now on the correct path.  Instead of politicians imposing their ignorant opinions on you, your doctor will now be making the decisions and that is the way it should be.  In time the right to prescribe will be extended to GPs.  For now the truly wonderful news is that we are no longer engaged in a battle with the law. What it’s about now is patience and education.

Written by Peter Reynolds

October 12, 2018 at 2:05 pm

Posted in Health, Politics

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Arrival After A 36 Year Journey.

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Today I have arrived at the destination I set out for in April 1983 when I first gave evidence on the use of cannabis as medicine to Parliament at the Home Affairs Select Committee Inquiry into ‘Dangerous Drugs’.

Sajid Javid MP, the Home Secretary, has announced that from 1st November 2018, consultants will be able to prescribe cannabis on the NHS. This will include herbal cannabis produced to GMP standards by organisations such as Bedrocan and Tilray.

I am only one of thousands of people who worked on this campaign and I congratulate all those with whom I have shared this journey. In these 36 years there have been more than 22,000 scientific papers published demonstrating the safety and efficacy of cannabis for a wide range of medical conditions.  This is how long it’s taken to get policy changed in the UK in accordance with evidence.

It’s appropriate that it should fall to the son of a Pakistani immigrant finally to sweep aside the prejudice and wilful ignorance that has stood in the way.

Written by Peter Reynolds

October 11, 2018 at 5:12 pm

Posted in Biography, Health, Politics

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CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.

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Last week, CLEAR was invited to participate in a teleconference with representatives of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).  This followed our written submissions made over the last few weeks.

The teleconference included two representatives from each party. The DHSC was represented by the Medicines Pharmacy and Industry section. The MHRA was represented by the Licensing Division.

CLEAR has now submitted a summary of all the advice offered which is reproduced below.

1. The definition of cannabis-derived medicinal products (CDMP) is for products that will be re-scheduled in the Misuse of Drugs Regulations out of schedule 1 and ostensibly into schedule 2.  These products will be available for prescription by doctors.

2. With the exception of Sativex, a whole plant cannabis extract with a THC:CBD ratio of 1:1, there are no cannabis-derived medicinal products available in the UK which have been licensed by the granting of a marketing authorisation (MA) or a Traditional Herbal Registration (THR). THR licensing is for minor ailments only that do not require the supervision of a doctor. MA licensing would be required for any CDMP aiming to treat most of the conditions for which cannabis is currently being used illicitly unless such CDMPs are prescribed as an unlicensed medicine.

3. In every other jurisdiction in the world where CDMPs are legally available, governments have recognised that licensing regimes designed to regulate single molecule pharmaceutical medicines synthesised in a lab are not suitable for regulating CDMPs. All such governments have either established entirely new cannabis regulators or created a specialist division within the existing medicines regulator.  If there is a genuine intent to enable legal access to CDMPs by the estimated one million people currently using illicit cannabis as medicine, this is the only practical route forwards. The cost and length of time involved in obtaining an MA makes them prohibitive for a plant-based medicine. Given the experience of using cannabis as medicine over many millennia, its non-toxic nature and very low risk profile, the rigorous approach of an MA is unnecessary.

Recommendation 1. A CDMP regulator should be established encompassing genuine expertise in the use of cannabis as medicine. The Cannabis Trades Association UK (CTA) is already in the process of developing the Cannabis Products Directive (CPD) in co-operation with the MHRA and FSA.

4. There is no justification or evidence that can support cannabis being in such a restrictive schedule as schedule 2 alongside opioids and cocaine.  The potential for causing social harm, which is the criterion used to determine the correct schedule, is several orders of magnitude greater with all existing schedule 2 drugs. They are all demonstrated to produce far higher levels of problematic dependence and long-term health harms than cannabis.

Recommendation 2. CDMPs should be re-scheduled into schedule 4 alongside Sativex.

5. The primary objective of the definition should be to ensure that the products are safe. Cannabis is non-toxic with no practical lethal dose and any harmful health or social effects are only likely with sustained and abusive use. In normal, moderate and especially medical use the potential for any harm is extremely low, certainly no higher than with common over-the-counter medicines. The main safety considerations are therefore the risk of contamination during cultivation and in subsequent processes such as extraction and refinement of oils, arising from the use of pesticides, herbicides, nutrients and solvents.

6. The definition should be wide enough to encompass all cannabis products that are produced to specified quality standards. It should not be so narrow as to prohibit high THC and/or low CBD products that may well be appropriate in individual circumstances. Prescribing guidelines should be issued to enable doctors to make appropriate clinical judgements on appropriate THC:CBD ratios for different conditions. These guidelines must be compiled by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine.  FOI Requests have revealed that none of the members of the panel have any knowledge, experience or expertise in the use of cannabis as medicine.

7. The definition should be wide enough to provide for a future in which doctors can vary THC:CBD ratios and terpene content in accordance with evidence for therapeutic effect. For example, in paediatric epilepsy, CBD has been shown to be the most important compound but some children require a small percentage of THC for it to become effective.  Doctors should be free to vary dosage in the same way as they do with many licensed medicines in accordance with the way the patient responds.

8. Regulators/authorities will properly require some independent assessment of the safety of products as defined above. The only such assessments currently available are Good Manufacturing Practice (GMP) and certification by the Cannabis Trades Association UK (CTA). By definition, these certifications are only available for products that are legally available and CTA only operates within the UK where only exempt, low-THC products (known as CBD products) are legally available. GMP certification is available on some cannabis products legally available outside the UK.

9. Cannabis consists of around 500 molecules including approx. 110 cannabinoids, 120 terpenes and 20 flavonoids which provide the important therapeutic effects, most effectively, when working together in what is known as ‘the entourage effect’. The most significant cannabinoids are believed to be THC and CBD. THC has long been demonised as the principal psychoactive component but it has very important therapeutic effects, notably as an analgesic, an anti-spasmodic and an appetite stimulant. CBD works as an analgesic, anti-inflammatory, anxiolytic and anti-psychotic.  It is beyond doubt that they work best together as they enhance each other’s positive effects and ameliorate any side effects. It is vital that cannabis for medical use contains a balance of both.  In some conditions, THC is more important than CBD and in others the reverse will be the case. We recommend that for medical use the ratio of THC:CBD should ideally not be less than 10:1.  This will protect against any negative effects of THC which a very small proportion of patients may be vulnerable to. In most instances, for medical use, the ideal THC:CBD ratio will be 1:1. Doctors should however be free to prescribe outside these parameters including high THC and high CBD products, subject to prescribing guidelines.

Recommendation 3. The definition of CDMPs should be primarily concerned with safety in the production process. CDMPs should have either a. GMP certification b. CTA certification c. an existing MA d. an existing THR. The composition and cannabinoid ratios of CDMPs should be a matter for determination by doctors in accordance with prescribing guidelines.

Recommendation 4. Prescribing guidelines for CDMPs should be developed by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine. 

10. Cannabis has traditionally been smoked and millions of people have gained great benefit from it over many centuries. The principal benefits of smoking, which are extremely important, without any of the negative effects, can now be achieved through vaporising. The benefits are rapid onset of therapeutic effect and accurate self-titration of dose.  When ingested, either through the GI system or absorbed through the mucus membranes, onset is much slower, the effect is prolonged and accurate titration is very difficult to achieve. Vaporisers are already in widespread use and a variety of different types are available.  The Storz and Bickel ‘Volcano’ has a CE mark and is a licensed medical device in Canada and Israel. The Teva Pharma ‘Syqe’  has completed three clinical trials with positive outcomes for safety and efficacy.

11. Vaporised, pharmaceutical-quality, standardised herbal cannabis with consistent cannabinoid and terpene levels is the gold standard in the use of cannabis as medicine.  Presently the only way to achieve this in Europe is with GMP-certified cannabis produced by Bedrocan BV, the Netherlands government officially contracted producer.  Some Canadian producers are also GMP certified.

Recommendation 5. Vaporisers should be made available on loan, for subsidised purchase or free-of-charge in accordance with existing provision for those in receipt of benefits.

12. The DHSC should prevail on GW Pharmaceuticals to reconsider its pricing strategy on Sativex which is presently under a ‘do not prescribe’ edict from NICE on the grounds that it is not cost-effective. The price of Sativex is extraordinarily high and products which, for all practical considerations of safety and efficacy, are identical are available over-the-counter for one-tenth of the price in US cannabis dispensaries. There is no justification for the price of Sativex except for the recovery of the cost of clinical trials which GW Pharma was required to engage in in order to obtain a marketing authorisation.  GW Pharmaceuticals should also be encouraged to make herbal cannabis products available as an alternative to Bedrocan, something it should be able to achieve within a few months with little difficulty.

13. Cannabis extracts and oils will be required for some patients, particularly children, and those that cannot or do not wish to use inhalation via a vaporiser.  Prescribing guidelines must recognise that the pharmacology of cannabis is totally different when ingested through the GI system or absorbed through the mucus membranes.  Absorption of oil through suppositories has also been found to a valuable method of ingestion.

14. While CLEAR fully supports decriminalisation of domestic cultivation of cannabis for personal use, homegrown cannabis should never be considered part of a therapeutic programme under the supervision of medical professionals.  The potential for contamination and poor quality is far too high.

Recommendation 6. In the short term, aside from low-THC exempt products known as CBD products, the only CDMPs readily available are from GW Pharmaceuticals, Bedrocan BV or Canadian producers, notably Tilray. Standardised herbal cannabis for vaporising or oils for other methods of ingestion should be available from these producers immediately.

15. Originally Nick Hurd MP, the Home Office minister, wrote in The Times, 29th June 2018, that cannabis would be rescheduled and could be prescribed by GPs whenever a benefit could be identified. Without any explanation that now appears to have morphed into ‘specialist’ or ‘senior’ clinicians and only in cases of ‘exceptional clinical need’.  As well as a broken promise which is causing widespread consternation, this is irrational, as are suggestions that cannabis should be regarded as a medicine of last resort.  The safety profile of cannabis is such that any rational, evidence-based policy would suggest cannabis as a medicine well before many analgesics, anxiolytics and anti-depressants which are widely, readily and regularly prescribed by doctors without any concern.

16. A workable definition of CDMPs together with well-informed prescribing guidelines that enable prescription by GPs for any condition where a benefit is identified is essential. Unless this is satisfactorily achieved, the one million people in the UK currently using cannabis as medicine will continue to do outside the law, outside any form of medicines regulation and without any medical supervision.  The likelihood is that this cohort of patients will continue to expand rapidly as knowledge of the therapeutic benefits of cannabis and its use in other countries becomes more widespread. The implications of failing to establish a proper regime are very significant for health, patient-doctor relationships, the criminal market in cannabis, the police and the criminal justice system. This is a nettle that must be grasped.

Recommendation 7. CDMPs should be available in accordance with the Home Office’s initial commitment, that is on prescription by GPs for any condition where a benefit can be identified

Nick Hurd MP, The Home Office And Their Massive Broken Promise On Medicinal Cannabis.

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Nick Hurd MP, Home Office Minister

On 29th June 2018 in The Times newspaper, Nick Hurd MP, minister of state at the Home Office, published the following promise:

“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.”

Source: ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’

Recently, including in response to a written parliamentary question on 7th September 2018, this promise has been dramatically broken and Mr Hurd’s message is now wholly different:

“The Home Secretary has confirmed that cannabis-derived medicinal products will be rescheduled. This means that senior clinicians will be able to prescribe the medicines to patients with an exceptional clinical need.”

Source: ‘Cannabis: Medical Treatments:Written question – 167359’

So ‘GPs’ has now become ‘senior clinicians’ and ‘open to patients suffering from all illnesses where such treatment is identified to benefit them.’ has become ‘exceptional clinical need’.  These are dramatic and far reaching changes which wholly change the nature of the promise made by Nick Hurd and will result in a highly restricted and limited regime making it very difficult for anyone to access cannabis as medicine.

This is a betrayal of the estimated one million people in the UK currently using cannabis to treat medical conditions.  It demonstrates how when this issue was in the headlines it provoked what was a sensible, measured and appropriate response. Now that the media storm has passed, in typical Home Office style, a totally different, hardline and repressive policy is being pushed through as quietly as possible.  No attempt has been made to explain why there has been such a dramatic change and it is quite clear that the Home Office hopes this will go through without attracting media attention.

CLEAR has submitted an FOI Request seeking a full explanation which can be seen here: ‘Provide full details concerning minister’s broken promise on the use of cannabis as medicine’

Written by Peter Reynolds

September 10, 2018 at 10:22 am

Posted in Health, Politics

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