Peter Reynolds

The life and times of Peter Reynolds

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

How Much So-Called ‘Anti-Semitism’ is Actually Opposition To Israeli War Crimes?

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Yes, On This Subject I Am A Corbyn Supporter

Yes, On This Subject I Am A Corbyn Supporter

It suits supporters of Netanyahu’s gangster regime to characterise any and all opposition to it as anti-semitism.  It’s also true that much of that opposition and emotional outrage is badly framed and expressed so that it can be easily or deliberately misinterpreted as opposition to the Jewish people and their religion.  But the Israeli regime itself plays fast and loose with the confusion between state, race, nationality and religion.  It twists and distorts anything to justify its apartheid policy and genocide of the Palestinian people.

Personally, I see very little anti-semitism.  In fact I cannot remember the last time I saw any words, behaviour or actions that could properly be described as such.  On the other hand there are daily examples of the brutal discrimination, oppression, murder, land theft and extra-judicial execution of Palestinians.

So I call total balderdash on the invented stories of anti-semitism within Labour.  In this instance, I believe Jeremy Corbyn and Shami Chakrabati are absolutely in the right.  Of course, there are the loony left extremists in Labour who are a danger to the whole of our society.  They undoubtedly push their delusional agenda of a Jewish banker mafia but they are bonkers anyway.  We all have to deal with their idiocy on a daily basis.  The far greater danger they pose is their already-achieved elimination of any effective parliamentary opposition.

No, the accusations of anti-semitism, including from the Home Affairs Committee, come from the pro-zionist apologists for Israeli war crimes.  I really don’t believe that amongst decent, honourable British people of all political persuasions, there is any significant anti-Jewish prejudice or actions.  Obviously I’m not saying it never happens but it’s largely Israeli government propaganda.

The answer is to root out the corrupt Israeli lobby in the UK Parliament and in US Senate and Congress.  Stand up to Netanyahu and the despicable conduct of so many in the Knesset. Give the Israeli people back the freedom to live in peace with their neighbours and for the nation to flourish without the hatred and oppression which constrains it today.

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.

The Man From The MHRA. Endangering Public Health With Precipitate Action On CBD.

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Dr Ian Hudson, Chief Executive, MHRA

Dr Ian Hudson, Chief Executive, MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) apparent decision to designate cannabidiol (CBD) as a medicine is an unholy mess and has been handled about as badly as it is possible for a government agency to deal with a matter of public safety.

The desk of Dr Ian Hudson, the Chief Executive, will shortly be groaning under the weight of correspondence from MPs asking him to explain exactly what is going on.  We know that the MHRA call centre has been swamped with calls from people desperate for information and in fear that they will be cut off from supplies of the food supplement that is so important for their health.  Many are now being told that no final decision has been taken and everyone is in limbo waiting for some coherent response.  We say “apparent decision” because nothing is clear, no public statement has been issued and anything you have seen in the press is from responses to individuals.

Crispin Blunt, the Conservative MP and a member of the CLEAR advisory board has written to Dr Hudson urging him to meet with CLEAR, Professor Mike Barnes and the newly-formed UK Cannabis Trade Association to discuss what interim arrangements can be put in place.  Tens of thousands of people’s health has been placed in jeopardy and not for trivial matters.  People suffering from serious conditions such as epilepsy, chronic pain, anxiety and Crohn’s Disease have come to rely on CBD products to maintain their health. There are also hundreds of jobs in danger at suppliers providing CBD to the UK market.

We know that many CLEAR members have asked their MP to write to the MHRA seeking clarification.  In Crispin Blunt’s letter he goes further.

“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. I should be grateful, therefore, if you could explain how the MHRA reached its decision, the consultations it undertook, which specific regulatory regime it proposes for these products and whether the continued supply of these products, regulated as food supplements, can be ensured until such time medicinal marketing authorisations can be obtained.”

CLEAR has received a holding response from the MHRA indicating that a meeting will be arranged and that we will hear by the end of this week. Responsible action from a government agency that is supposed to protect, not endanger public health is urgently needed.


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.