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Peter Reynolds

The life and times of Peter Reynolds

Archive for the ‘Health’ Category

Let’s Nail the Home Office’s Latest Smokescreen About Medical Cannabis

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As the evidence and support for legal access to cannabis for medical use grows, so the Home Office adjusts and reframes its arguments in denial.

This should come as no surprise. The ‘hostile environment’ revealed by the Windrush scandal runs through the Home Office like a stick of rock. The culture of this department is defined by Theresa May and it reflects her character and personality. It is secretive, demands total control and micro management of everything it touches and whenever it is challenged it finds another excuse to maintain its iron rule. It is institutionally dishonest.

A Home Office spokeswoman said:

“We recognise that people with chronic pain and debilitating illnesses are looking to alleviate their symptoms. However, it is important that medicines are thoroughly tested to ensure they meet rigorous standards before being placed on the market, so doctors and patients are assured of their efficacy and safety.”

The truth is rather different. In every jurisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. You cannot regulate a 500 molecule plant-based medicine in the same way as a single molecule synthesised in a lab.

Regulation by 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.

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.

So next time you hear this, the last, lame excuse from a government ideologically opposed to this long overdue reform, treat it and them with the contempt they deserve. They prefer that people should continue in pain, suffering and disability than that they should do what science and medicine says is right.

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Written by Peter Reynolds

May 16, 2018 at 1:46 pm

The UK Government’s Latest Excuse About Medicinal Cannabis Is Yet Another Deception.

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Nick Hurd MP, Home Office Minister

Nick Hurd MP, the Home Office minister, said again this week that as far as any consideration of cannabis for medical use is concerned, the government will “await the outcome” of the report on cannabis due from the WHO in 2019 “before considering the next steps”.

In fact, the results of an FOI request show that the UK government has refused to take part in the WHO committee which will “review cannabis and cannabis-related substances on their potential to cause dependence, abuse and harm to health, and potential therapeutic applications”. This despite the WHO issuing a questionnaire to the Department of Health and Social Care “designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control”.

Aside from the obvious concerns this raises, it is quite extraordinary considering that the UK is the world’s largest producer and exporter of legal cannabis.

Fundamentally the government’s postion on cannabis for medical use hasn’t changed since 1971. Those who follow the Home Office’s statements will have noticed gradual changes but they all seek to reinforce the fundamental premise that cannabis is a dangerous drug of abuse with no therapeutic benefit.

Recent ‘adjustments’, shall we call them, of the official position have dealt with the now overwhelming weight of evidence that cannabis does have very real and significant medical value.  The response has been to caution that all medicines must go through the etablished system of testing for safety and efficacy.

This is a deception as well.  As CLEAR revealed at the beginning of 2018, in every jurisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation.

Theresa May is ideologically opposed to the use of cannabis as medicine, it’s as simple as that.  She won’t permit it to be properly considered, discussed or investigated and every time something forces a response, such as a parliamentary question or an enquiry even from a fellow Conservative MP, another deceptive excuse is conjured up.

Victoria Atkins MP, Theresa May MP. Both Have Family Interests In Cannabis For Medical Use.

CLEAR can further reveal that the Home Office’s public position on prospects for licensed cannabis medicnes is also a deception. The statement that has been published is “As happened in the case of Sativex, the Home Office will consider issuing a licence to enable trials of any new medicine…”  We can’t name names just yet but we now have first hand knowledge that at least one publicly-quoted company with established cannabis production facilities in two other G7 countries has been refused permission by the Home Office even to apply for a licence.

The UK government’s stance on cannabis becomes murkier and murkier the deeper you look.  The stench of corruption becomes overpowering when you consider that Theresa May’s husband’s company is the largest single shareholder in GW Pharmaceuticals and the husband of Victoria Atkins MP, the drugs minister, holds a licence to produce 45 acres of cannabis for medical use.

Written by Peter Reynolds

May 12, 2018 at 6:24 pm

There Was Grenfell, Then The Windrush Generation And Now Theresa May Fiddles While Alfie Dingley Faces Death

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When Will This Tyrant Be Overthrown?

The campaign to save Alfie Dingley’s life looked to have succeeded on 20th March when 108 MPs met Alfie and family at Parliament. That same day, accompanied by Sir Patrick Stewart, a petition of over 370,000 signatures was delivered to Downing Street and Theresa May herself met with the family and encouraged them that everything possible would be done to help. Originally, the Home Office were suggesting that they might issue a licence to allow a bespoke trial of medical cannabis but that changed to a suggestion that they would consider issuing a licence on a ‘compassionate basis’. They also  indicated that they might issue the licence for Alfie within days rather than weeks.

Home Office Minister Nick Hurd MP appears to support the petition delivered to Downing Street. Today (3rd May 2016) the petition has gown to over 650,000 signatures.

A  formal application for a licence was submitted to the Home Office on 16th April 2018 by Alfie’s GP and a consultant neurologist. This was raised at Prime Minister’s Questions two days later and once again Mrs May expressed sympathy and promised that the Home Office would look at it “speedily”.

Now, Hannah, Alfie’s mother, has been told that it could take up to four months for the application to be considered and even then no one can be certain what the decision will be.

Apparently this is because the medical cannabis oil needs to be ‘tested’, whatever that means.  Is this a U turn to requiring a full clinical trial to be undertaken? If so, how can a clinical trial be undertaken on one boy with a particular form of epilepsy so rare that he is said to be one of only nine boys in the world?  Clearly a clinical trial with the normal double blind testing is impossible.  So what other form of ‘testing’ needs to be carried out?

The oil has already been tested on Alfie under the supervision of a consultant neurologist in the Netherlands.  There, having experienced up to 30 seizures per day in the UK, after taking three drops of oil per day he had only two seizures in two months.  The oil is made by Bedrocan, the Netherlands government official contractor for the production of cannabis for medical use and already complies with international standards for Good Manufacturing Practice (GMP).

The only conclusion that can be drawn is that this is yet more procrastination and deliberate delay by a government that is notorious for its inhumane treatment of many people.  Theresa May has a long standing and well documented record of being opposed to any drug law reform and of dismissing the campaign for access to cannabis for medical use as ‘just an excuse to take cannabis’.  With the sole exception of President Duterte of the Philippines, who is engaged in a murderous campaign of extra-judicial execution of suspected drug dealers, Mrs May is the only world leader still calling for the ‘war on drugs’ to continue.

After scandal after scandal after scandal it is difficult to see what will finally bring Mrs May down.  In Britain, where the idea of democracy has become little more than a bad joke, it seems that infighting within the Conservative Party over Europe is a more likely reason for her downfall than the grave abuses of individuals for which she is ultimately responsible.

Let’s be 100% clear, the Misuse of Drugs Act 1971 makes specific provision for any action that would otherwise be unlawful under the Act to be permitted under licence by the Home Secretary.  It would take a single stroke of Sajid Javid’s pen to save Alfie Dingley’s life and Theresa May could have ordered that months ago.

Famously, Mrs May is a practising Christian.  Surely, there must be a special place in hell reserved for her.

Written by Peter Reynolds

May 3, 2018 at 3:54 pm

The Facts About CBD In The UK. April 2018.

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This article is an update to ‘The Facts About CBD In The UK. December 2016.

The past three years have seen a true phenomenon develop around the cannabis law reform movement which has quickly crossed into mainstream society, commerce and general awareness.  It’s the explosion of the CBD market, a trade that has grown from zero to £50 million per annum in the UK in this very short period.

There has been a great deal of nonsense published about the market, the products and their legality both under drugs laws, food and medicines regulation. The facts that are set out in this article are established from close involvement with the developing market on a daily basis as well as consultation with a number of lawyers of all types and levels of experience as well as direct contact with the Home Office, the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA) and other authorities.

The market has been driven initially because of growing interest in the medical benefits of cannabis and the recognition that, within certain constraints, products derived from low-THC cannabis, legally grown under licence as industrial hemp, are a legal alternative.  An important factor has been that CBD is most often consumed by placing a few drops of oil under the tongue. This has avoided the stigma of smoking a joint and is more in line with the way people perceive a medicine or health food.

The CBD market has also exposed the contradictions, inconsistencies and errors in the Misuse of Drugs legislation and particularly in the confused and inconsistent way in which the Home Office attempts to administer it. For instance, currently there are CBD products produced legally in other EU countries and the USA which can legally be sold in the UK but which the Home Office will not permit UK companies to produce.

Ironically, the most significant development has been that responsible CBD suppliers have moved away from claiming the sort of medical benefits that are, in fact, the reason for the market’s existence.  Although everyone knows this is why people are buying CBD, if you’re in the business of supplying the products you can’t say a thing, not even indirectly, about the medical benefits it offers.

18 months ago, all the leading and responsible suppliers of CBD products in the UK joined together to create their own trade association.  The Cannabis Trades Association UK (CTA UK) now represents 80% by turnover of all the CBD suppliers in the UK. It is governed by its members who have established a set of standards on products, labelling and marketing which all abide by.  These standards are designed to protect and inform consumers and to ensure that all CTA UK members are compliant with the law.

The formation of CTA UK was prompted by the MHRA issuing warnings to some suppliers about making medical claims for their products. To remain within the law, CBD products must be sold as food supplements and the most that can be said about them is that they help to improve and maintain health and wellbeing.  Before any product can be marketed with medicinal claims it must have a marketing authorisation from the MHRA. Food supplements must also comply with certain laws and regulations administered by the FSA.

CTA UK is now engaged in a continuous dialogue with both the MHRA and FSA.  Regular meetings are held to consider new suppliers and products entering the market to ensure they comply with the law, regulations and CTA UK standards.

When supplied by a CTA UK member, consumers can be certain that the product they are buying is 100% legal and is accurately labelled and described.  CBD is not a ’controlled drug’.  It does not appear in any of the classifications or schedules to the Misuse of Drugs Act 1971.

There is widespread misunderstanding about the 0.2% THC limit in industrial hemp.  This is the limit in the growing plant and is not relevant to CBD products.  Clearly what may be under 0.2% in the growing plant would be far higher in an extract which is, by definition, concentrated. The Misuse of Drugs Regulations 2001 make it clear that any product derived from low-THC cannabis grown legally under licence as industrial hemp is “exempt” provided it contains “not more than one milligram” of THC or CBN. This is the limit that matters. See The Misuse of Drugs Regulations 2001 ‘Interpretation’ 2-(1) (a)(b)(c)

Contrary to suggestions that the market is “in chaos”, “half-legal”, “a bit of a mess” and other spurious claims, in fact, it is a model of self-regulation where the industry itself has put aside its competitive instincts to co-operate for the benefit of consumers and in its own long term self-interest.

No suppliers will be admitted to membership of CTAUK unless they cease making medicinal claims, stop selling illegal products (for instance with high levels of THC, described as ‘indica’ or intended for pets or veterinary purposes).  Indeed, any suppliers that continue such conduct are likely to be subject to enforcement action by the MHRA and Trading Standards.

There are further changes or clarifications in the law relating to some CBD products which have emerged in the last few weeks.  These arise out of regulations from the FSA.  Isolates or pure CBD are now no longer permitted as they have been classified as ‘novel foods’.  This could mean a prison sentence of up to two years for anyone selling them.

It’s a myth, although regularly reported in the press, that there has been any change in the law or that CBD has been made legal or classified as a medicine. CBD products can already be prescribed by doctors without any restriction, just as any other food supplement. When the inevitable cannabis law reform takes place it will still be unlawful to make medicinal claims about any CBD or cannabis product without a marketing authorisation from the MHRA.

Within the next few months, the first CBD medicine will receive a marketing authorisation from the MHRA. Epidiolex, a whole plant extract, refined to deliver 98% CBD, is GW Pharmaceuticals’ second cannabis-derived prescription medicine which is intended for severe forms of paediatric epilepsy. It is not derived from industrial hemp but from high CBD strains of cannabis grown specifically for the purpose. It should be noted that this is to be administered in massive doses of up to 20 mg per day per kg of body weight,  CBD as a food supplement for adults has a maximum recommended dose of 200mg per day.

The CBD food supplement market will continue to grow.  Other medicines may be authorised in the near future, most likely under the MHRA’s Traditional Herbal Registration scheme, which will permit them to be described as medicines for minor ailments not requiring the supervision of a doctor.

Clearly, it remains urgent that our government gets to grips with the reality of the need and benefits of cannabis for medical use in the wider sense. However, even as we begin to make progress the CBD market in its present form will continue to fulfil an important need for many years to come.

 

 

 

 

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.

Talking Cannabis With the MHRA

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MHRA Headquarters

In November 2016 I organised a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) and a number of key players in the CBD market.  It was in response to the MHRA seeking to clamp down on sales of CBD oil and related products.  That meeting led directly to the formation of the Cannabis Trades Association UK (CTAUK) which now represents more than 80% by turnover of all CBD suppliers in the UK.

Since that first meeting my friend and colleague Mike Harlington has taken on the leadership role at CTAUK and I give him great credit for what has been achieved.  We expect formal recognition by the MHRA is only a few weeks away and that is a tremendous coup.  For the first time ever, in the face of total intransigence by government, we have established to a significant degree a legally regulated cannabis market.  Clearly, it doesn’t yet go anywhere near far enough but this is the most concrete move ever towards long overdue cannabis law reform.

The first 18 months of CTAUK have not been easy.  Other than the MHRA, the other branches of government concerned are the Food Standards Agency (FSA) and the Home Office.  The FSA has also become a close working partner but, unsurprisingly, the Home Office remains difficult and our efforts to engage constructively with it have been characterised by responses that are inconsistent, irrational, contradictory and a realisation that it’s losing its grip on cannabis policy.  It is impossible to deal with.  In fact, I almost sympathise with the unfortunate civil servants charged with administering a policy that is itself irrational and contradictory and driven only by outdated prohibitionist values.  Maladministration of the Misuse of Drugs Act is now a persistent reality and several legal challenges to the Home Office’s conduct are imminent.  Soon the High Court will become involved in UK cannabis policy and then, in theory, facts and evidence should prevail rather than propaganda and government disinformation.

Dr Chris Jones

The CTAUK has been engaged in regular meetings with the MHRA and I was invited along for the most recent occasion.  The CTAUK team was Mike Harlington, Tom Whettem of Canabidol and myself.  The MHRA team was Dr Chris Jones, head of the Borderline Medicines section and Raj Gor. We discussed many administrative matters and gave a great deal of time again to discussing medicinal claims and how members could avoid mistakes.  It seems obvious that no claims of medicinal benefit can be made but there are many instances where it’s not clear cut.  A particular case we looked at was the use of ‘night’ and ‘day’ CBD products.  Eventually it was agreed that this description is acceptable but only just. This is an excellent example of how CTAUK works to represent its members’ interests and with goodwill on both sides how positive agreement can be reached.

On a continuing, day-to-day basis CTAUK and MHRA are in constant touch, ironing out problems, asking for and taking advice from each other.  I am impressed with the way the relationship has evolved and jointly we bring great benefit to the industry and consumers.

UK Is The Only Country In the World To Criminalise Doctors Who Prescribe Cannabis

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Bob Ainsworth MP. Like so many ex-ministers, now a supporter of cannabis law reform

It’s popularly believed that the obstacle to prescription of cannabis by doctors is that it is in schedule 1 of the Misuse of Drugs Regulations.  In fact, in 2001, the then drugs minster, Labour’s Bob Ainsworth MP, enacted a little known provision of the Misuse of Drugs Act 1971 UK specifically to make prescribing of cannabis a criminal offence.

Extraordinarily, apart from mescaline, raw opium, coca leaf, DMT and some extremely rare substances that most people will never have heard of, cannabis is the only substance to which this ruling applies.  The Statutory Instrument can be seen here. It designated cannabis as a drug to which section 7(4) of the Misuse of Drugs Act 1971 applies.  I have reproduced the relevant sections at the end of this article.

Why?  Well that is a very good question and one that will no doubt be subject to endless speculation.  Could it be because only a couple of years previously the House of Lords Science and Technology Committee had recommended that it be available on prescription? No doubt the conspiracy theorists will connect it to that fact that only six months previously GW Pharmaceuticals PLC  had floated on the Alternative Investment Market of the London Stock Exchange.  It certainly demonstrates a determination by the then Labour government to restrict and prevent the medical use of cannabis as tightly as the law could possibly allow. It is unprecedented that such rigid controls should be placed, without any supporting evidence, on a substance which we know from recorded history has been used as a medicine for at least 5,000 years.

What is most important is what this means for law reform.  Removing cannabis from schedule 1 would be insufficient to allow doctors to prescribe it. The Statutory Instrument would also need to be rescinded so that section 7(4) of the Act no longer applied to it.

Amber Rudd MP. A single stroke of her pen can save Alfie Dingley

 

However, what this highlights is that the scheduling of cannabis and its use as medicine is entirely within the discretion of the Home Secretary.  The present incumbent, Amber Rudd MP, or any of her successors can, entirely on her own account, make any change to the scheduling of cannabis or doctors’ ability to prescribe it.  She can also issue a licence on whatever terms she chooses to enable individual prescription, importation or possession.

In other words, the fate of Alfie Dingley and thousands more is entirely in Amber Rudd’s hands.  The dishonest excuses advanced by junior Home Office minister Nick Hurd, that they “want to explore every option within the current regulatory framework” is obfuscation, doublespeak and deception at its most blatant.

 

 

The Misuse of Drugs Act 1971 section 7(3) and (4) Source: https://www.legislation.gov.uk/ukpga/1971/38/section/7

(3)Subject to subsection (4) below, the Secretary of State shall so exercise his power to make regulations under subsection (1) above as to secure—

(a)that it is not unlawful under section 4(1) of this Act for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply a controlled drug, or for a pharmacist or a person lawfully conducting a retail pharmacy business, acting in either case in his capacity as such, to manufacture, compound or supply a controlled drug; and

(b)that it is not unlawful under section 5(1) of this Act for a doctor, dentist, veterinary practitioner, veterinary surgeon, pharmacist or person lawfully conducting a retail pharmacy business to have a controlled drug in his possession for the purpose of acting in his capacity as such.

(4)If in the case of any controlled drug the Secretary of State is of the opinion that it is in the public interest—

(a)for production, supply and possession of that drug to be either wholly unlawful or unlawful except for purposes of research or other special purposes; or

(b)for it to be unlawful for practitioners, pharmacists and persons lawfully conducting retail pharmacy businesses to do in relation to that drug any of the things mentioned in subsection (3) above except under a licence or other authority issued by the Secretary of State,

he may by order designate that drug as a drug to which this subsection applies; and while there is in force an order under this subsection designating a controlled drug as one to which this subsection applies, subsection (3) above shall not apply as regards that drug.

Written by Peter Reynolds

March 18, 2018 at 5:09 pm