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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Home Office

NICE’s Draft Guidelines on Cannabis Prove That Its Methods Don’t Work and It Is Causing Harm to Patients

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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.

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Asking Politicians to Order Doctors to Prescribe Cannabis is a Futile Quest

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Last year, when Sajid Javid introduced the new regulations permitting prescribing of cannabis-based products for medicinal use (CBPMs) he went much further than anyone could have expected.

For 50 years doctors had been told that cannabis was a highly toxic, dangerous drug with no therapeutic value.  Then, in the space of few weeks they were suddenly told by the Chief Medical Officer that there was “conclusive evidence” of therapeutic benefit. The truth is successive governments and the Home Office had been engaged in systematic disinformation and lies about cannabis. Suddenly they expected doctors to believe exactly the opposite of what they had been told before.

In fact, what Sajid Javid really did was to pass the buck, so while I have some sympathy for the predicament of doctors and total contempt for our pathetic political class, the buck is now in the right place.  However, we have a medical establishment that is so risk averse and so crushed by bureaucracy that it is transfixed by the challenge of getting to grips with cannabis and there is a total lack of leadership from the Royal Colleges or any of the professional bodies. The ultimate demonstration of this is that the British Paediatric Neurology Association wants doctors to consider brain surgery for epilepsy before prescribing cannabis.  This is a profession that has lost touch with reality and common sense.

The result is that doctors will not prescribe cannabis but the idea that they can be ordered to do so by politicians is a non-starter.  It is difficult to understand what campaigners hope to achieve by marching on Westminster and lobbying MPs.

Eventually, the efforts that are being made in medical education will bear fruit and doctors will start to prescribe but this will take time and many will suffer while they wait for doctors to catch up with what is already well understood in many parts of the world.

So what can be done?

Government can take action on two fronts which will accelerate progress. First of all, improve supply.  By its own admission, in response to an FOI Request, the Home Office has done nothing to facilitate production of CBPMs. This could be changed immediately. There is a queue of well qualified and financed companies ready to develop production facilities.  While Sajid Javid cannot order doctors to prescribe, he can order his reluctant and backwards officials to issue licences.  Within a year we can have a domestic supply of CBPMs and the doctors will have something to prescribe and products they can become familiar with.

The second way government can act is on regulation.  Doctors are terrified of cannabis and need reassurance. Everything they have been taught goes against prescribing cannabis.

However, cannabis is safe for 99% of people. We know this from 10,000 years of experience. The hysterical scaremongering from places such as the Institute of Psychiatry are actually aboput a tiny proportion of people using high strength cannabis as a recreational drug, a totally different circumstance to a high quality medicinal product used under close supervision. As a plant-based medicine, cannabis contains 400 – 500 molecules unlike pharmaceutical medicines which are usually a single molecule. It is impossible therefore to regulate cannabis in the same way as pharmaceuticals and given millennia of experience it is unnecessary.

In every other jurisdiction in the world where cannabis has been made legally available for medical use a separate system of regulation for it has been established. Until UK follows this path, the pharmaceutical-funded medical establishment will never accept cannabis as a legitimate medicine.

So what politicans can do is free up the supply chain for CBPMs and regulate them in an appropriate and rational way.  This is where we need to be focused in order to make progress and bring relief and a healthier life to millions.

Written by Peter Reynolds

March 19, 2019 at 1:26 pm

Cannabis and CBD. UK and EU Bureaucrats -v- The People and Parliament.

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For decades, public opinion and knowledge on cannabis has been way ahead of those in Parliament and civil servants in the Home Office and the Department of Health.

In other countries, governments have been more ready to update themselves on scientific knowledge and they are more speedily held to account through more effective democracies. At last, the UK Parliament has acted on access to cannabis for medical use as it should have 20 years ago.  Both Canada and the Netherlands introduced legal access in 2001 and California even five years before that.

But the will of Parliament is being stifled and subverted by bureaucracts in the NHS and the Department of Health.  As MPs are never shy to remind us, under our constitution, Parliament is supreme.  That makes the conduct of these civil servants unlawful.  They are being obstructive about the prescribing of cannabis.  They need to be compliant with the law or they become guilty of maladminstration.  We should have no more patience with this wilful misconduct.  Their responsibility is to facilitate implementation of the law, not find ways to delay it because of their personal opinions.

The same goes for the Home Office which has done absolutely nothing to revise its cannabis licensing policy in accordance with the new regulations.  Well-qualified, experienced, international corporations, willing to make multimillion pound investments in Britain to produce the cannabis-based products (CBPMs) which we need are being refused licences for no good reason. If the products are not available, how will they ever reach the patients who Parliament has decreed are entitled to access them?

For 50 years, the Home Office has run a systematic campaign of disinformation because it is institutionally opposed to cannabis. Until Sajid Javid, civil servants have thwarted the efforts of all minsters that have tried to introduce any drugs policy reform.  Now he has to stand up against the subversive forces within his own department or someone has to fund judical review of the Home Office’s maladminstration of cannabis licensing. Just as in the Windrush Scandal, the Home Office maintains a ‘hostile environment’ based on senior civil servants’ personal prejudices rather than the best interests of Britain and now, the law.

CBD. Big Pharma Protectionism, Bureaucrat Box-Ticking or Both?

Many people are not yet aware of the meddling that is going on with CBD products.  There is a real threat that they could be removed from sale within the next few months.  This depsite their soaring popularity with the public and that hundreds, if not thousands of people are now employed in our burgeoning CBD industry.

CBD products are, in fact, whole plant extracts from low-THC cannabis which meet the criteria under drugs law to be exempt.  They have become very popular because people were seeking a legal way of accessing the medicinal benefits of cannabis which have become widely understood, mainly as the internet has provided knowledge previously suppressed by government and media scaremongering.

Two years ago, the meddling began as civil servants from the MHRA, the medicines regulator, stepped in with heavy-handed threats to close the market down because of unlawful medicinal claims.  To be fair, there was good justification for this.  Medicines regulation is an essential function of government, otherwise we will have snake oil confidence tricksters selling coloured water as a cancer cure.  So CLEAR acted and organised a response to the MHRA from the leading CBD companies.  Now, the responsible and ethical companies have regulated themselves, stopped making medicinal claims and market their products as food supplements, just like vitamins and minerals than can help to maintain health and boost wellness.

So CBD companies have successfully negotiated their way through both drugs and medicines law but now the food police have stepped in with yet more problems.  This time the civil servants objections are entirely unnecessary and unjustifiable but they are the most serious threat that CBD companies and consumers have faced.

The Food Standards Agency (FSA) from the UK and its opposite numbers in other EU countries have placed cannabis extracts in the EU Novel Foods Catalogue, which is for products that have not been consumed to a significant degree in the EU before 1997. This means that without going through a lengthy and very expensive authorisation process, all CBD products could become unlawful to sell.

Why?  When I met with the FSA and its novel foods team just over a week ago, it acknowledged that the purpose of the novel foods regulations was to ensure that food products and supplements are safe.  It also confirmed that it had no evidence that cannabis extracts or CBD products are unsafe. So, on the face of it, this seems to be simply a matter of bureaucrats who want their boxes ticked, for no other reason than that is what bureaucrats do.

But the widely-held opinion from those in the know, is that what is really behind this are the vested interests of painkiller companies who are seeing a big impact on sales of their products. Even the World Health Organization has recently given CBD an unequivocal endorsement as safe and effective, whereas the toxicity of paracetamol, ibuprofen, other NSAIDs and opioids is now well understood.

You see, however CBD products are sold, it is an indisputable fact that they are purchased for their medicinal benefit – and that they work.  This is a big threat to pharmaceutical company profits and so they are wielding their big stick.  They tried through the MHRA to close down CBD and now they are trying through the FSA.

Exactly the same thing is happening in the USA.  The recent passage of the Farm Bill has removed CBD from the Controlled Substances Act but now the FDA (which combines the functions of our MHRA and FSA) has stepped in and said it is illegal to sell as a food supplement because it is the active ingredient in a licensed medicine.

We Will Overcome

So a battle royal is starting.  What the outcome will be is uncertain.  It is complex and multi-threaded.  Different strategies are being developed and varying ideas are being put forward as to how to deal with this threat.  Many people now rely on CBD for their health and the imminent threat of it not being available is a danger to individuals and so to our entire society.

Whatever happens, I am certain that commonsense and the people will prevail.  For a century, the use of cannabis as medicine has continued despite every effort from governments and vested interests to stamp it out.  The same will happen with CBD.  Even it it disappears from the high street, it will continue to be available online and if it can’t be sold as a food supplement, it will move into a new category.

Once again, it will take politicians far too long to wake up and out-of-control civil servants will try to pursue their own agenda which, I am quite sure, is under the corrupt and improper influence of big business.  It will be challenging and very difficult but the people have dealt with these dark forces before and we will continue to do so.

Written by Peter Reynolds

February 10, 2019 at 2:19 pm

Cannabis Professionals. The Trade Association for the UK’s Cannabis, CBD and Hemp Businesses

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Cannabis Professionals (CannaPro) is the trade association for the UK’s cannabis, CBD and hemp businesses.

CannaPro will represent this fast-growing sector to the authorities, standing up to the Home Office, MHRA, FSA and Trading Standards, advocating for members’ interests, not acting as a government enforcer but as our members’ champion and to promote the development of the legal cannabis sector.

CannaPro will offer guidance and support to all businesses, helping them to navigate through law and regulations on drugs, medicines, food and cosmetics.

CannaPro will also launch a social media campaign, aiming to inform and educate the public about the benefits of CBD and the pitfalls.  The market is full of scammers, fake claims and snake oil salesmen.  Because of the historic stigma and fear around cannabis, government authorities are doing nothing, many people are misinformed and misunderstand.  CannaPro will explain the facts clearly and direct consumers to certified businesses which they can rely on.

Membership of CannaPro is without charge. All guidance will be published openly for everyone to benefit from. Free-of-charge support and answers to individual questions will be available online.

Businesses wishing to be certified by CannaPro will be reviewed for their products, trading standards, marketing and conduct. Certified companies will be entitled to display the CannaPro badge as a mark of quality, ethics and reliability.

Backed by CLEAR, the UK’s longest-established cannabis group with a network exceeding all other UK drugs policy groups combined, CannaPro members will benefit from CLEAR’s wide reach and influence with UK consumers.

Website: https://cannapro-uk.org

Facebook Group: https://www.facebook.com/groups/cannapro/

Written by Peter Reynolds

November 20, 2018 at 4:52 pm

Cannabis Advocates Really Need To Stop Accusing Doctors of Being Bribed By Pharmaceutical Companies.

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There may well be some doctors who are corrupt and there are still, despite much improvement, serious questions over the relationship between pharma companies and doctors but the idea that every member of the Faculty of Pain Medicine who signed that letter to the Times is taking bribes is ridiculous.

The real reason is ignorance and that’s not an attack on doctors, it’s a reason.  They have been subject to the same relentless torrent of reefer madness propaganda from government and media as the rest of society.  They have been prevented even from learning about the endocannabinoid system by the authoritarian policy of prohibition and any doctor in the UK who has any experience of cannabis as medicine will have been in breach of professional ethics as well as the law.

CLEAR has been working with some of the very few enlightened doctors since way before the cause of cannabis as medicine became fashionable.  Working with members, their MPs and doctors, we have organised lobbying of ministers and MPs over more than the past 10 years. In several instances we had doctors, both GPs and consultants, contact the Home Office to enquire about obtaining a licence for a specific patient.  In at least three instances these doctors were then contacted by Home Office officials who warned them off using threats and intimidation.  Shocking but completely true.

It is and it always has been government – stupid, prejudiced, bigoted and self-opinionated politicians – who have prevented access to cannabis, even in the face of overwhelming evidence.  This means that there has been no education at all and doctors are as poorly informed as everyone else. They’re also, and understandably, worried, even scared.  They don’t understand cannabis, many will not even have heard of the endocannabinoid system and they are concerned about being sued, professionally disgraced, losing their job and now of being swamped by patients demanding cannabis about which they know nothing.

Of course, it was thoroughly stupid to assert in the letter that “the evidence suggests that the prescribing of cannabis (containing the psychoactive and addictive tetrahydrocannabinol component) will provide little or no long-term benefit in improving pain and may be associated with significant long-term adverse cognitive and mental-health detriment.”

There is no reasonable interpretation of the evidence that supports this. THC can be addictive in a very modest sense but the withdrawal symptoms and negative effects are trivial compared to those from opioids which doctors prescribe readily and frequently.  There is excellent evidence from many sources that cannabis containing THC and CBD benefits pain and while there may be some cognitive and mental health effects, to suggest they are significant or even come remotely close to those from opioids is false and in opposition to the evidence.

I repeat, doctors aren’t saying this because they are bribed by pharmaceutical companies, it’s because they have no idea what they are talking about.

The urgent requirement now is medical education.  It is amazing how radical the new regulations are and many people still don’t seem to realise how far the government has gone.  They go much further than we at CLEAR had even dared to dream and the definition of cannabis-derived medicinal product (CDMP) is very broad.  When we were consulted on it by the Department of Health and MHRA we never thought they would accept all our recommendations.  They enable the prescription of every form of cannabis, including flower, oil and concentrate, provided they meet quality standards.

So the problem with the law is gone. Literally, it is all over. It is absolute and total victory. Now two big problems remain. Education is the first but this is being addressed.  NICE has acted commendably fast to start recruiting a panel to advise on prescribing guidelines and Professor Mike Barnes, CLEAR’s scientific and medical advisor has already developed a series of introductory online training modules. Early in November his Medical Cannabis Clinicians Society launches and this will be an important forum for the future.

The second big problem is supply.  Where are the CDMPs to come from?  Sativex falls into the definition and this was GW Pharma’s big opportunity to act responsibly and imaginatively.  The possibility still exists that it will substantially reduce the absurd, rip-off price that it has been charging for Sativex since 2010.  If it had the imagination it could very easily turn over some of its production to unlicensed CDMPs for which there is now a ready market. I fear that it is wedded to licensed products only, hugely expensive and, in my judgement, unnecessary clinical trials and very high prices for its end products.  If so, then I will be selling my shares.  I admire the company for its courage, innovation and high standards but if it does not seize this opportunity then I believe it is failing in its duty to shareholders and also to Britain, which let’s remember has gifted it a privileged and unique opportunity in the world.  Fail now to provide for the needs of UK patients and that amounts to betrayal.

So for now the only possible sources of supply that meet the definition will be Bedrocan in the Netherlands and some of the Canadian licensed producers. US companies cannot export.  Neither can the Israeli companies and they would also face a thoroughly deserved boycott of their products even if Netanyahu was to issue export licences.  Bedrocan can barely meet demand from its existing customers and there is talk of it having difficulties with a ceiling on its export licenses. Only some Canadian producers meet the required GMP quality standards and they too are facing shortages as they also supply the recently legalised recreational market which is seriously short of product.

So the Home Office has to act and start issuing domestic production licences and it has to do so immediately.  Whether it will, remains to be seen.  Its drugs licensing department is a shambles, staffed by officials who do not even understand the law they are supposed to administrate, who regularly give different, contradictory answers on different days and exceed their lawful authority as a matter of course.  If there is a ‘hostile environment’ for immigration in the Home Office, for drugs licensing and cannabis production it has been hostile but also aggressive, paranoid and stupid ever since the Misuse of Drugs Act 1971.

The urgent need is for prospective British cannabis producers to mobilise their MPs and for immediate pressure to be brought on the Home Office at the highest level.  Sajid Javid has shown he can act decisively.  Expanding domestic cannabis production is the inevitable next step in what he has already achieved.  He must act now.

So the future in the UK for those who need cannabis as medicine is brighter than could ever have been imagined.  The next steps are challenging but nowhere near as difficult as the campaign to reform the law that CLEAR has fought for nearly 20 years.  Don’t blame doctors, continue to blame the government and hold their feet to the fire until they act on medical education and cannabis production as they must.

Statement Concerning The Cannabis Trades Association UK

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With regret, I have withdrawn my endorsement of and support for the Hemp Trade Association Ltd (HTA) trading as Cannabis Trades Association UK (CTA).

I created and founded CTA in September 2016. Since November 2016, HTA has traded under the CTA name with my permission and I was appointed to its advisory board.  That permission has been withdrawn from 18th October 2018 and I have resigned from the advisory board with immediate effect.

The reasons behind this are complex and great effort has been made to resolve differences and agree a way forward but this has proved impossible to achieve.  The reasons include but are not limited to:

Systematic Dishonesty

Over the two years of HTA’s existence many false claims have been made, in particular about HTA’s relationship with the MHRA and FSA, alleged exclusive stakeholder arrangements and HTA’s ‘authority’ to regulate the CBD market.  Further claims have been made by the chairman about his links with the security services, other Home Office staff, ‘inside information’ and unlawful use of government computer systems to run DBS and criminal record checks on prospective members. HTA’s reputation and that of its members was severely damaged by the chairman’s recent conduct in relation to the States of Guernsey, which resulted in official government repudiation of his claims, and his personal feud with a major CBD supplier which is not a member.

Misuse of Members’ Funds

Members pay membership fees primarily in order to have their interests effectively represented to government and the authorities. In practice, very little if any of this takes place and instead membership fees are used to finance the chairman’s ambitions to establish the Cannabis Products Directive (CPD) across Europe. While some members are supportive of the CPD initiative, it is not HTA’s purpose, nor is extending HTA’s operations outside UK.

Failure to Represent Members’ Interests

Instead of representing members’ concerns and interests to the authorities, HTA acts as an enforcer for the authorities. The chairman has confirmed in writing that HTA will “never go against” and will always “work with the authorities”. Members who have complained about lack of action against non-compliant CBD suppliers have been told to “stop bitching”.  Non-compliant CBD suppliers is the issue of principal concern to members but HTA has failed to take this up effectively. As a result, it is a positive disadvantage to be a member of HTA as members are subject to stricter enforcement and additional costs than non-members.

Maladminstration of HTA, a Company Limited By Guarantee

HTA was fomed as company limited by guarantee deliberately to place control in the hands of its members rather than its directors. Members have not been properly included in decisions.  They have been subjected to autocratic rule, prevented from obtaining proxy votes and resolutions at general meetings have been railroaded through without time for proper discussion. Protests by members at such treatment have resulted in them being ejected from discussion groups.

Bullying, Threats and Intimidation

A large number of reports have been received from former and current members detailing instances of such behaviour as coercion to join HTA or to comply with HTA policies.

Chairman’s Antecedents

Evidence has come to light which reveals that the chairman has a string of 28 dissolved companies behind him and a large number of oustanding county court judgements relating to those companies. He is also indebted to the company of another director of HTA in a substantial five figure sum for a period in excess of two years with no effort made to commence repayment. As a result that director has now resigned.

Unlawful Restrictions on Members

Legal advice has been received which confirms that HTA has been exercising unlawful restrictions on members preventing them from trading freely.  This supports allegations that have been published accusing HTA of running a ‘protection racket’.

 

 

 

Written by Peter Reynolds

October 16, 2018 at 2:48 pm

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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