Peter Reynolds

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Posts Tagged ‘cannabis

VIDEO. ‘This House Would Legalise Cannabis’. Reynolds v Hitchens. University Of Southampton, 29th September 2016.

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Recording of a debate on the legalisation of cannabis which took place on Thursday 29th September 2016 at the University of Southampton, hosted by Southampton Debating Union.

Written by Peter Reynolds

October 21, 2016 at 12:24 pm

MHRA Confirms Meeting With CBD Industry Representatives.

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Today, the Medicines and Healthcare products Regulatory Agency (MHRA), has arranged a meeting with representatives from the UK Cannabis Trade Association (UKCTA) to discuss its designation of cannabidiol (CBD) as a medicine.

mhra-logoA request for a meeting was was first made in writing on 20th September 2016, when the possibility of the MHRA’s action was still little more than a rumour.  Nearly six weeks later, after repeated requests, complaints and lobbying from many companies, individuals and MPs, the meeting has been fixed for 3rd November 2016.

The main aim of the meeting will be to discuss interim arrangements for people currently using CBD as a food supplement.  Clearly, we will also address concerns over the impact of this decision on many small businesses and the people they employ.

Written by Peter Reynolds

October 19, 2016 at 5:08 pm

The British Medical Journal (BMJ) Features The CLEAR Medicinal Cannabis Campaign.

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By Nigel Hawkes

By Nigel Hawkes

“Muddled thinking” over cannabis leaves patients in limbo, warn campaigners

BMJ 2016; 355 doi: (Published 14 October 2016) Cite this as: BMJ 2016;355:i5556

Download PDF here

Companies selling cannabis based products have been told to remove them from the market within 28 days, after a review by the Medicines and Healthcare Products Regulatory Agency (MHRA) determined that they were medicinal products.

Campaigners for cannabis law reform welcomed the recognition that cannabidiol (CBD) had medicinal properties but warned that the MHRA’s action would deprive thousands of users of a product they relied on. They said that it was impossible to obtain marketing authorisation in the timescale given and may never be possible given the high costs of clinical trials and lack of patent protection for a product that contained many components.

“In the long term, it’s a good thing,” said Peter Reynolds of the pressure group CLEAR Cannabis Law Reform. “But my immediate concern is for the tens of thousands of people who use CBD and have become reliant on it. We urgently need interim measures so that supplies can continue.”

The MHRA sent letters on 3 October to 18 companies that sold CBD, saying that it had concluded that CBD met the definition of a medicinal product as defined in the Human Medicines Regulations as “any substance or combination of substances which may be used or administered to human beings either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action or to making a medical diagnosis.”

This meant, the letter said, that CBD products required a marketing authorisation before they could be sold. Marketing authorisation for drugs requires lengthy clinical trials, only justifiable if the product has patent protection. An alternative route is under the traditional herbal medicines regulations, but that requires evidence that the product has 30 years of use and applies only to minor conditions, where medical supervision is not required. Reynolds said that he thought it unlikely that CBD could qualify by this route.

Mike Barnes, a neurologist and former NHS consultant and chief executive, is clinical adviser to CLEAR. He said, “The decision by the MRHA to treat CBD products as medicines has also been done without thought to the consequences for many thousands of people in the UK who currently benefit from the products. It will have very significant, and in many cases terminal, impact on the many legitimate businesses that provide high quality products.

“The government must now act to sort out their muddled thinking and try to help those people with long term and often painful conditions who benefit from the ready and hitherto legal availability of natural cannabis products. It is ironic that in acknowledging the therapeutic benefits of CBD, the MRHA is effectively suspending access to a product that has enhanced the lives of thousands for many years.”

Crispin Blunt, an MP and CLEAR supporter, has written to the MHRA saying that the decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.

“It is vital that we do not let this anomaly in government policy cause harm to people’s health,” his letter said. He asked for details of how the decision was reached, the consultations undertaken, which specific regulatory regime MHRA proposed for these products, and whether the continued supply of these products, regulated as food supplements, could be ensured until such time that medicinal marketing authorisations could be obtained.

The MHRA has not yet posted details on its website about the decision. In a statement it said that people who used CBD should speak to their GP or other healthcare professional. “We can provide regulatory guidance to any company who may wish to apply for a licence,” the statement added.

Professor Mike Barnes Speaks Out On the CBD Ban.

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Professor Mike Barnes, Scientific and Medical Advisor to CLEAR

Professor Mike Barnes, neurologist, scientific and medical advisor to CLEAR Cannabis Law Reform, has issued the following statement.

“It is encouraging that the MRHA is recognising that CBD has medicinal value but it is concerning that many people benefitting from CBD now will suffer in the short term as good quality manufacturers have to stop production pending MRHA approval” 

A redacted copy of the letter now being sent to all CBD suppliers can be seen here.

For some weeks, rumours and half stories have been swirling around about the MHRA taking action on CBD.

Initially a number of suppliers were warned about making medicinal claims, even testimonials from satisfied customers were ruled as unlawful.  Anything which suggested that CBD was a medicine or provided therapeutic effects was ruled out under UK medicines legislation.

Responsible CBD suppliers have known this for some time and were scrupulous in ensuring no such claims were made, even including disclaimers explicitly stating that their products were not for medical use. But as CLEAR has reported many times before, the CBD market is full of cowboys, get-rich-quick scam artists that tell bare faced lies about their products as well as making outlandish claims for the medicinal benefits.  The crackdown from the MHRA was inevitable when these fools put their short term gain ahead of developing a responsible and self-regulating market in which CBD could continue to be sold as a food supplement.

We have seen every sort of bad practice it is possible to imagine.  Some suppliers have attacked all of their competitors, stating that they are the only ‘ethical’ supplier and everyone else is telling lies.  MediPen put all its resources and efforts into marketing and PR without providing proper information to customers about what its product contained.  It achieved great coverage in tabloids like the Metro and the Mirror and even managed to spin a wholly misleading story that the NHS was “trialling” its product (In fact it was at last using an NHS accredited laboratory to test its product contents, that is all).  Another supplier called Sacred Kana was rebranding cheap and nasty Romanian hemp extract and selling a bottle for just over £50, claiming it contained 10,000 mg of CBD.  Testing showed that it actually contained less than 200 mg. Wrapped up in a warm, cuddly hippy-style marketing campaign, they were trying to pass themselves off as the Rick Simpson of CBD when all they are is conmen.

Responsible suppliers did include CBD information on their websites and often linked to scientific studies and research.  Clearly, even this has become too much for the MHRA and now the market is being closed down.  You can thank the greedy idiots, the conmen and the barrow boy salesmen trying to pretend they were scientists.

Of course the truth is that CBD is medicine, so the MHRA isn’t wrong.  Most CBD products are, in fact, low-THC, whole plant extracts, so they were, effectively, a legal form of cannabis.  The therapeutic benefits they offered were not just from CBD but from the ‘entourage effect’, recognised by science as the synergy between all the different components of cannabis.  Unfortunately, we even had some companies promoting the fact that their so-called ‘CBD oil’ actually contained significant proportions of THC and CBN, both ‘controlled drugs’ under the Misuse of Drugs Act 1971.

The crackdown was inevitable but it may leave tens of thousands of people with real health problems as they are no longer able to obtain what they were legitimately using as a food supplement.

Crispin Blunt MP, Political Advisor to CLEAR

Crispin Blunt MP, Political Advisor to CLEAR

Of course, designating CBD as a medicine is inconsistent with the UK government’s position that cannabis has “no medicinal value” but it’s been common knowledge that this is untrue for many years.  The only good news coming out of this debacle is that this could be the beginning of proper, honest regulation of cannabis as medicine. But if we’re looking at clinical trials before CBD can be marketed again, it could be many years away and that’s after someone or some company decides to invest the £250,000 or more that could cost.

CBD products will still be available offshore and you probably will be able to order online and have them delivered by post.  The price is bound to go up and you will be committing a criminal offence by importing an unlicensed medicine but no doubt may will choose to take this risk.

CLEAR is working with the UK Cannabis Trade Association and our Advisory Board members Professor Mike Barnes and Crispin Blunt MP, to try and persuade the MHRA to enter a consultation process and allow CBD to remain available as a food supplement in the short term.

In the longer term, as we know far too well, the only solution is for a proper system of regulation for cannabis. including its use as medicine.

Fast Developing News On CBD And Medicinal Cannabis.

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We learned today that the Medicines and Healthcare products Regulatory Agency (MHRA) has started issuing letters to CBD suppliers advising them that CBD is being designated as a medicine and that sale of CBD products must stop within 28 days.

This will be alarming news to many people.  However, it is a complex situation which has some positive aspects to it.  In the short term, if you are already using CBD products, you would be well advised to stock up as much as you can afford.

CLEAR has been aware of this possibility for several weeks and consequently we have been working with leading CBD suppliers and licensed producers of both low and high THC cannabis on establishing the UK Cannabis Trade Association (UKCTA).  We are already in correspondence with the MHRA seeking to represent all stakeholders, to establish a consultation process on regulating CBD products and to protect the interests of producers, suppliers and consumers.

lovehemp-oilWhat these MHRA letters mean is that for CBD to be sold in future, suppliers will have to obtain either a ‘marketing authorisation’ or a ‘traditional herbal registration’ from the MHRA.

A marketing authorisation can be fantastically expensive, requiring an initial application fee of £103,000 and full scale clinical trials demonstrating safety and efficacy.

A traditional herbal registration is not as expensive, around £6,000 but relies on the product having been “traditionally used to treat the stated condition for a minimum of 30 years, 15 years of which must have been in the European Union (EU).”  It also requires “scientific evidence relating to the safety, quality and traditional use of the herbal product”. It is far from certain that CBD will qualify for this scheme and in any event registration is only granted if the medicine is used for minor health conditions where medical supervision is not required.

CBD is not a ‘controlled drug’ and is not prohibited but most CBD products are in fact low-THC, whole plant extracts derived from industrial hemp, legally grown under licence.  So yes, they are a legal form of cannabis and, of course, according to the Misuse of Drugs Act 1971, cannabis has ‘no medicinal value’.  So, you may well ask, how can the MHRA classify it as a medicine?

MHRA Headquarters

MHRA Headquarters

This is just the first of many complications for the MHRA, the Home Office and the government. Potentially, it could be very positive as it could make the government acknowledge the medicinal value of cannabis and, in effect, force the beginning of cannabis regulation.

It has been certain for some time that many of the CBD products presently on the market are unlawful because they contain levels of THC and CBN which exceed the limits stated in the Misuse of Drugs Regulations 2001. Some CBD suppliers have taken a head in the sand attitude to this, even in some cases foolishly promoting the THC levels in their products. This led to CLEAR removing its  endorsement of one supplier earlier this year and recommending CBD Oils UK instead.

epidiolexThe path ahead is uncertain. The UKCTA is pressing for an urgent meeting with the MHRA. Apart from the advice to consumers to stock up, these will be very worrying times for CBD suppliers and their employees. Another factor is that GW Pharmaceuticals is very close to applying for FDA approval in the USA and an MHRA marketing authorisation for its CBD epilepsy medicine, Epidiolex.

CLEAR, the UKCTA and leading CBD companies are working together to clarify and progress this situation.  We will keep you closely informed of developments.

It Sticks In My Throat But Theresa Is Magnificent.

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The Andrew Marr Show. 2nd October 2016

The Andrew Marr Show. 2nd October 2016

Ms May’s performance on the Andrew Marr Show today was a triumph.

She delivered common sense, wit, an inclusive vision and very broad appeal.  In a “country that works for everyone” she is undermining the incoherent left. She is showing true leadership in excellent style.

Now all we have to do is get her properly informed about cannabis and drugs policy.  I cannot believe that someone who is so rational and considered can fail to understand.  I think the truth is that prejudice and years of propaganda is so entrenched, even in sophisticated, intelligent people, that some politicians, including Theresa, have not had the evidence properly presented to them.

We must do better to get our message across and somehow we have to get Theresa May properly to consider our arguments.

Written by Peter Reynolds

October 2, 2016 at 9:13 am

‘This House Would Legalise Cannabis’. Reynolds v Hitchens. University Of Southampton, 29th September 2016.

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A vote was taken before the debate started: For the proposition: 49  Against the proposition: 18  Abstain/undecided: 17

A Good Attendance

A Good Attendance

John Pritchard, studying economics. For the proposition.

Jacob Power, studying philosophy. Against the proposition.

Peter Reynolds, CLEAR Cannabis Law Reform. For the proposition.

Peter Hitchens, Mail on Sunday. Against the proposition.

A vote was taken after the debate finished: For the proposition: 57  Against the proposition: 26  Abstain/undecided: 8

My speech

I start with an assertion that I think we can all agree on – the only purpose of any drugs policy is to reduce harm.

I argue that British drugs policy, specifically on cannabis, causes far more harm than it prevents and that the solution is to legalise. But by legalise, I do not mean a free for all.  In fact, I  mean a system of regulation which minimises harm.

Under the Misuse of Drugs Act, cannabis is called a “controlled drug” but nothing could be further from the truth. What every government since 1971 has done is abandon all control. They have abandoned our communities.  they have abandoned our young people and they have abandoned those who need cannabis as medicine.  All of them, Conservative, Labour and the coalition, they have abandoned us all to criminals.

The results are street dealing, dangerous hidden cannabis farms that cause fires, theft of electricity, destruction of rental properties, gangs that exploit children, both by selling them cannabis and getting them involved in dealing, human trafficking, modern slavery, most often Vietnamese children, smuggled into Britain and locked up in cannabis farms to look after the plants. And as for the product itself, it is frequently poor quality and often contaminated with toxic residues.

These are the harms that the Misuse of Drugs Act is supposed to prevent but, in fact, it creates them, promotes them and maximises them.

Now, it may surprise you to know that the law is not about protecting people from health harms.  The exact words of the Act are that it is about the misuse of drugs “having harmful effects sufficient to constitute a social problem”.  It is social harm that the Act seeks to prevent.

Which is just as well because the “harmful effects” of cannabis are very difficult to identify.  Most of what you hear is either wild exaggeration or completely false.  Even the Institute of Psychiatry, the source of many scare stories, admitted last year that its press office was misrepresenting and exaggerating its own research.

Now t’other Peter will tell you that cannabis is a dangerous drug which can cause serious, irreversible mental illness.  In a debate like this it is impossible to compare all the various scientific studies that form the body of evidence on which cannabis policy should be based.  I can certainly answer specific questions later on but for now, let’s rely, not on evidence, but on cold, hard facts.

The populist myth is that thousands of young people are afflicted by this terrible condition called ‘cannabis psychosis’.  The facts are that in the last five years there has been an average of just 28 finished admission episodes in hospitals each year for people under 18 for cannabis psychosis.

Of course these are 28 tragedies and I don’t overlook that but in public health terms it is an insignificant figure.  For instance, there are more than 3,000 finished admission episodes each year for peanut allergy but we don’t spend £500 million each year on a futile attempt to ban peanuts, do we? Yes, that’s how much we spend every year on police, courts, probation and prison services to try and stop people using cannabis.

However, it’s not as simple as that.  Apart from hospitals, thousands of people each year receive what’s called ‘treatment’ for cannabis use disorder from community health services.  Nearly 16,000 young people for the year 2014/15.

Now the only ‘treatment’ for cannabis is counselling but that’s not what this is really about.  It’s actually about trying to force people to stop using cannabis regardless of whether it’s causing any harm. Public Health England, which records these figures, shows that 89% of all those in treatment have been referred from the courts, educational institutions or some other authority.  In other words this is coercive treatment.  You have no option.  If you don’t agree the courts will impose a tougher penalty or you might get expelled from school.  Only 11% of those receiving this treatment actually decide they need it themselves.

Don’t get me wrong now, I’m neither suggesting cannabis is harmless nor that it can’t be a real problem for some people.  But I ask you this, if it has the potential for harm, is it better that we leave the entire market, now worth £6 billion per year, in the hands of criminals, or would it be better and safer for everyone if it was properly regulated and controlled?  Wouldn’t any health harms be reduced, better treated, if we had quality control, age limits, proper labelling of what you’re buying?  Isn’t this obvious, common sense?

We will continue to put most of our effort into the medical campaign because that is what morality and compassion demands   But actually, there is far more harm caused by the prohibition of recreational use.  As well as all the social harms I mentioned earlier, do you know there are one million people in the UK with a conviction for cannabis?  People whose careers, ability to travel, even their credit score can be damaged because they got caught smoking a joint. 

In all jurisdictions where cannabis is legally available, the benefits are dramatic and very easy to see.  In Holland, far fewer children use cannabis than in the UK.  Underage use is declining in Colorado, Washington, Oregon, Alaska where cannabis is legal for all adults and in the other 30 US states where medical cannabis is legal.  Crime is down, fatal traffic accidents are down, alcohol consumption is down, overdoses and deaths from dangerous opioid painkillers are down.

The prohibition of cannabis is a great force for evil in our society.  It promotes crime, it maximises the health harms of cannabis, it ruins lives, it denies people medicine that science proves will help them, it blights communities, endangers children, fritters away precious law enforcement resources.

Indeed, prohibition is a fundamentally immoral policy.  It sets the police and the courts against the communities they are supposed to protect.  After all, the demand comes from us and it is not going away.  We are adults, free human beings who are entitled to act as we wish provided it doesn’t harm others.  Our government and our police should serve us.  It is an affront to justice, to the rule of law, to morality and to each one of us that this oppressive, ridiculous, evidence-free policy persists.

Legalise cannabis now!  Please vote in favour of the motion.