Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘FDA

Fast Developing News On CBD And Medicinal Cannabis.

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cbd-molecule-spoon-oil

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.

The Man Who Smashed UK Cannabis Prohibition – And Looks Set To Do The Same In America.

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Dr Geoffrey Guy

Dr Geoffrey Guy

Across social media, it’s ‘on message’ to despise Big Pharma and to promote the idea that government and pharmaceutical companies are engaged in the business of making people ill and feeding them with drugs in the pursuit of profit.

In the cannabis campaign, it’s virtually compulsory to abuse, defame and promote conspiracy theories about GW Pharmaceuticals, the world’s leading developer of cannabis-based medicines.

Now GW Pharma is hardly ‘Big Pharma’. It’s annual revenues for 2014 were £30 million. By contrast, Pfizer’s 2014 revenue was $50 billion. But such trifling facts are of no concern to the keyboard warriors and trolls that plague the cannabis campaign and bring it into disrepute every day.

In any case, I’m not sure whose message this is and why anyone buys into this hate-filled invective and unjust condemnation of an industry that has saved so many lives. Antibiotics, vaccines and, yes, chemotherapy products have saved or extended millions of lives. The most profitable pharmaceutical product of all time, Zantac (ranitidine), cures or prevents stomach ulcers and has prevented millions from having to undergo major surgery. Certainly, as in any industry, there have been mistakes, things have gone wrong and much could be improved but overall, the pharmaceutical industry is a huge force for good in our world.

Those engaged in these bitter, vindictive, online campaigns are largely sheep, ignorant of the facts and simply jumping on another hysterical bandwagon that they understand nothing about. They complain about the pursuit of profit and that money is being made from medicines and healthcare. It’s a strangely socialist and anti-business attitude, particularly as so much of it comes from America, supposedly the home of free enterprise where the maverick and outsider who triumphs against all the odds is usually revered.

Dr Geoffrey Guy, who founded GW Pharmaceuticals in 1998, is such a man. He has broken the UK government’s prohibition of cannabis by outwitting a regulatory process run by the Home Office and the Medicines and Healthcare Products Regulatory Agency (MHRA) that is corrupt, dishonest and denies scientific evidence. In my view, he deserves great admiration and should be seen as a hero by cannabis campaigners, not as the villain that he is often portrayed.

Now, both GW’s lead products, Sativex and Epidiolex, look set to gain FDA approval in the US. This will be a fantastic achievement for Dr Guy and all his colleagues. It’s also something that we Britons should be immensely proud about. Even though America is a very long way ahead of us in understanding and using cannabis as medicine, it is British science and expertise that is breaking down US federal prohibition. Soon most Americans will have state sanctioned access to medical marijuana but also the option for doctor-prescribed cannabinoid medicine of unparalleled quality and consistency.

Of course, for now GW Pharma stands against the use of raw herbal cannabis and at present that’s a rational business decision but I won’t be at all surprised if in future it moves into that market too. There are already unconfirmed rumours that GW is considering entering the CBD market.

This is a story of enormous courage, innovation and triumph against all the odds.  It is in the finest tradition of British ingenuity and business skill. Since the Middle Ages we have led the world in engineering, science and technology. Geoffrey Guy is another world leader from Britain, this small island that has given birth to so many. Surely, at least a knighthood, possibly a Nobel prize must be coming his way soon. Even if the curmudgeonly, loud mouthed critics of today attack him, in future years he will be seen as a great pioneer of medicine and he will deserve his place in history.

Written by Peter Reynolds

August 7, 2015 at 3:03 pm