Posts Tagged ‘Sativex’
Essentially, UK government policy on cannabis hasn’t altered since 1971. Despite the vast amount of new evidence published since then and revolutionary change, particularly on medicinal use, all across the world, successive governments have stubbornly and obstinately refused to consider any sort of reform.
It doesn’t matter which party has been in power, Conservative, Labour or the coalition, it’s a subject that ministers and MPs simply refuse to engage with. It’s easier that way for them and be in no doubt: laziness, fear of a media backlash and deeply ingrained prejudice are the key factors in this impasse.
We had the downgrade to class C in 2003 and then back up to B in 2009 but this was a turgid and useless effort. No notice was taken of any evidence arising from this experiment. It was enacted to enable police to concentrate more on class A drugs and reversed based on Gordon Brown’s ‘Presbyterian conscience’ and a grubby, corrupt deal with Paul Dacre to win the Daily Mail’s political support. In fact, use went down while cannabis was class C and back up again when it was upgraded but governments have no interest in facts or evidence on this subject, only in political expediency and spinning advantage with the media.
The clamour for medicinal access has increased enormously, just as the evidence for its safety and efficacy has become overwhelming. The UK is now virtually isolated amongst first world countries with a cruel, inhumane and anti-evidence policy which makes us a laughing stock with all who are properly informed. It’s not a laughing matter for the victims though. For those persecuted by this nasty policy it is tears, pain, suffering, disability – all of which could be alleviated to at least some extent just by a stroke of the Home Secretary’s pen. It is sickening that all those who have held that office over the last 45 years escape without any shame or opprobrium on their character.
CLEAR receives hundreds of letters and emails every year from people who have written to their MP about medicinal cannabis and it is astonishing that unlike almost every other policy, exactly the same words are used by all MPs. They slavishly repeat the Home Office line which is ruthlessly enforced across party lines.
There have been some subtle changes. The marketing authorisation issued for Sativex in 2010 has led to a minor change in the tired and inaccurate line ‘there is no medicinal value in cannabis’. It’s now become ‘there is no medicinal value in raw cannabis’. This is scientifically and factually incorrect. Pharmacologically, Sativex and the ‘raw’ plants from which it is made are identical. It is whole plant cannabis oil and its authorisation by the MHRA as an extract of THC and CBD is fundamentally dishonest. GW Pharmaceuticals reveals it contains more than 400 molecules, the MHRA says it only contains two and “unspecified impurities”.
More recently, and in the face of an explosion of supportive evidence, another line has been added. This states that ‘the UK has a well established process for the approval of medicines through the MHRA and that any company wishing to bring a medicinal cannabis product to market should follow this procedure. In fact, inside sources suggest that the government is very keen to see new cannabis-based medicines approved by the MHRA. It would take the wind out of the sails of the medical cannabis campaign
This is the very last excuse for denying access to medicinal cannabis. It is nothing but an excuse and one that is misleading and based on deception. If we can expose how weak, inappropriate and fake it is, the government will have nowhere else to hide.
Firstly, as demonstrated with Sativex, the MHRA process is incapable of dealing with a medicine that contains hundreds of molecules. It is designed by the pharmaceutical industry for regulating single molecule medicines, usually synthesised in a lab, which have the potential to be highly toxic. CLEAR rejects the tired, boring theory that ‘Big Pharma’ is engaged in a massive conspiracy to deny access to cannabis and to ‘keep people ill’ so it can continue to sell its products to the NHS. The MHRA isn’t engaged in such malevolent conduct, it’s simply incapable of properly evaluating a whole plant extract through its existing methods.
The bright, shining truth of this, that totally demolishes the government’s position, is that in every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. 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.
Of course, there is also the ludicrous status of cannabis as a schedule 1 drug, which prevents doctors from prescribing it. If it was moved to schedule 2, alongside heroin and cocaine, or to schedule 4 alongside Sativex (the logical choice), doctors could be prescribing it tomorrow and high-quality, GMP and EU regulated medicinal cannabis from Bedrocan would be immediately available.
So 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.
This is now the most important factor in achieving medical cannabis law reform. Next time you contact your MP or in any advocacy or campaign work you do, this is where to focus your energy. Cannabis is a special case, it is not like other medicines. Once we can open the eyes to this truth the path ahead will be clear.
The Times reports “Stone me: cannabis users don’t like hard work”
The Independent says “Getting high on cannabis makes you less likely to work hard for money, study says”
The mendacious Daily Mail claims: “How just one cannabis joint harms your will to work: Fears long-term drug use could harm motivation even when not high”
Utterly pointless research. Such results can be determined by common sense and experience.
UCL has a habit of frittering money away on pointless research into cannabis.
First of all we had the reckless overdosing of Jon Snow for the Channel 4 Drugs Live programme, equivalent to asking a teetotaller to drink a bottle of scotch in 10 minutes – set up purely for sensationalism and tabloid headlines. Results? Cannabis was shown to be very safe for 95% of people – as if we didn’t know that already.
Currently Prof Val Curran is studying whether cannabis can be used to treat cannabis dependency. Yes, seriously, Sativex, the cannabis oil mouthspray, is being trialled to see if it can help people give up smoking cannabis!! Not that cannabis dependency is anything like a serious problem anyway. Fewer regular users of cannabis become dependent on it than regular users of coffee become dependent on caffeine. Incredibly the University of Sydney is also conducting an identical trial.
Now we have this absurd study on motivation. Why do people use cannabis? To relax of course, so hardly surprising they become less motivated, that is the point! And the study showed that motivation returns to normal levels after smoking! You really couldn’t make it up that so-called scientists waste their time on this sort of nonsense.
What we need is some constructive research on the therapeutic benefits of cannabis. In the 34 US states that permit medicinal use, expenditure on dangerous and addictive pharmaceutical painkillers has plummeted by hundreds of millions of dollars.
Now that would be something sensible to look into. But maybe it doesn’t suit the agenda of whoever provides UCL with money to conduct its frivolous and pointless studies?
CLEAR has formed a partnership with the research arm of GroGlo, a UK-based manufacturer of high power, LED, horticultural grow lighting.
The plan is to grow cannabis under a Home Office licence for the production of cannabis oil, both as a dietary supplement and for the development of medical products. To begin with, a low-THC crop of industrial hemp will be planted. We will be using the finola strain, originally developed in Finland and known for its short stature and early flowering. Unlike hemp grown for fibre, finola is usually grown for seed and only reaches a height of 160 – 180 cm but we will be removing male plants before they produce pollen and cultivating the female plants to produce the maximum yield of oil from their flowering tops.
The low-THC oil will be marketed as a dietary supplement, commonly known as CBD oil. There is already a burgeoning market in the UK for CBD products, all of which is currently imported from Europe or the USA. In the USA, the CBD products market was said to be worth $85 million in 2015 so there is huge potential here at home. Aside from the benefit of being UK grown and processed, we anticipate achieving a CBD concentration of about 40%, which is higher than most products already on the market.
Cultivation will be in glasshouses supplemented with LED lighting. GroGlo already has an established glasshouse facility in the east of England. Initial trials will experiment with adjusting the LED technology to provide a changing blend of light wavelengths at different stages of plant growth. This is GroGlo’s area of expertise -combining LED lighting and plant sciences, including existing relationships with some of Europe’s top universities. Professor Mick Fuller, GroGlo’s director of plant science, will lead this research and development process.
During the R&D phase, CO2 extraction of oil will be carried out under laboratory conditions at universities in York and Nottingham which already have extensive experience of the process. Each crop will be measured for yield, cannabinoid and terpene content using high pressure liquid chromatography (HPLC). Safety testing will also look for the presence of heavy metals and other contaminants. The results of testing will be fed back into cultivation and extraction processes to maximise yield and quality.
It is anticipated that the first batches of low-THC oil will be ready for market in six months. We are already in discussions with potential distributors and wholesalers. The CBD market in the UK is ripe for an effective marketing campaign which could build a very substantial business for whoever gets it right.
Once we are successfully achieving our production goals with low-THC cannabis, the same testing and development process will begin with high-THC varieties of cannabis. The aim will be to produce a range of oils extracted from single strains, selectively bred and stabilised for different THC:CBD ratios.
Professor Fuller says that GroGlo lighting products “are in use worldwide to grow a range of crops, but some 60% of sales currently come from overseas users growing cannabis for legitimate medical use.” He explains that there is an emerging market for all sorts of nutritional and medicinal plant products but cannabis shows particular promise. GW Pharmaceuticals is the only UK company to enter this market and it has become a world leader, despite the current restrictive legislation. He says: “Together with CLEAR we believe we can help bring a range of safe, high quality UK-produced cannabis products to market within a matter of two to three years.”
A key issue in the development of a successful medicinal cannabis product is the method of delivery. Smoking is not an acceptable solution as inhaling the products of combustion is an unhealthy practice but one of the great benefits of cannabis smoked as medicine is very accurate self-titration. That is the effects of inhaled cannabis are felt almost instantly and so the patient knows when they have taken enough or when they need more to achieve the required analgesic effect.
The oral mucosal spray developed for Sativex is unpopular with patients, many complain of mouth sores from its use and it was developed at least as much with the objective of deterring ‘recreational’ use of the product as with delivering the medicine effectively. It strangles the therapeutic benefits of the cannabis oil of which Sativex is composed in order to comply with the concerns of the medicines regulators about ‘diversion’ of the product into what they would term ‘misuse’. Absorption of the oil is quicker through the mucous membranes of the inside of the mouth than through the gastrointestinal system but, inevitably, some of the oil is swallowed and the pharmacology of cannabis when processed through the gut and the liver is very different.
We believe the best option is a vapouriser device and our intention is to source a ‘vape pen’ of sufficient quality to operate within clinical standards of consistency and safety. Vapourising cannabis oil avoids inhaling the products of combustion but still enables accurate self-titration of dose. A vape pen would provide a handy, convenient and very effective method of consuming medicinal cannabis. However, aside from the technology itself, initial research shows that vapour is more effectively produced when the oil is blended with either vegetable glycerin (VG) or propylene glycol (PG). Establishing the correct ratio of VG or PG to the oil is another important task.
We anticipate that clinical trials for the use of cannabis oil in treating chronic pain could start within two years. We want to compare different oils, ranging from high-CBD to equal ratios of THC:CBD and high-THC content. Prior to that we have to overcome the challenges of cultivation, oil extraction, vapouriser development and assemble the necessary research team and gain ethical approval for the trials. Recruitment for the trials will start in about 18 months time. If you wish to be considered please email ‘email@example.com’ with brief details of your condition (no more than 100 words). Do not expect to hear anything for at least 12 months but your details will be passed to the research team as a potential candidate.
CLEAR is promoting this venture simply because someone needs to do something to make this happen. For all the campaigning and lobbying of MPs and ministers, at the end of the day, the plants have to be grown and the various legislative hoops have to be jumped through. We cannot wait any longer for a radical change in the law. We have to progress through the government’s regulatory regime if we want to bring real therapeutic benfit to patients.
This opportunity arises because of the vision of GroGlo’s managing director, Mike Harlington and the team of experts he has built around him. There is huge demand for legitimate medicinal cannabis products in the UK which is only going to increase with the inevitable progress towards law reform and increasing awareness of the benefits of cannabis. Together, CLEAR and GroGlo are bringing the great hope that medicinal cannabis offers closer to reality than ever before.
“Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”
One of these vape pens contains Blue Dream sativa cannabis oil, 91% THC, the other is Hindu Kush indica cannabis oil, 85% THC and the spare cartridge has the dregs of some New York City Diesel sativa, 85% THC. You can’t tell which is which to look at them but each has a distinctive flavour and effect. They’re not completely odour free but almost.
This is the future of cannabis as a consumer product. It is cleaner, neater, handier, healthier and better for you than raw herbal cannabis. Most importantly, for medicinal applications, it homogenises all the compounds into an oil of consistent quality and content meaning that dosage and effect at last becomes predictable and reliable.
I have been investigating this theory for some time but my recent trip to Colorado enabled me to conduct some practical experiments and more thoroughly understand how this idea can work. I am now convinced that this is the way forward for the cannabis industry. Once we achieve legalisation in the UK, which is inevitable, probably in about five years, these pens are how cannabis will become available as a consumer product on the high street. They are also how medicinal cannabis will be dispensed. Your doctor’s prescription will be fulfilled by a cartridge with the appropriate blend of cannabinoids which you screw onto your battery and use immediately. Batteries will also be supplied on prescription, in the same way that syringes or blood glucose meters are for diabetics.
In Colorado dispensaries these pens are already available in a choice of strains and blends. Currently, the popular products contain 250 mg of THC in a blend of cannabis oil and propylene glycol (PG), just as e-cigs contain a nicotine oil and PG.
Alternatively, you can buy the oil of your choice and fill the cartridges yourself. This is undoubtedly the way to do it and a wide choice of oils is available, made by CO2 and solvent extraction processes. The Farm, my favourite dispensary in Boulder, is already supplying cannabinoid blends such as a 60% CBD, 12% THC, 4% CBN product which is clearly for medicinal use. I have no doubt that soon we will see a Charlotte’s Web product and Sativex-like blends with equal ratios of THC:CBD. Other, more sophisticated blends of other cannabinoids and probably terpenes will soon follow.
However, I am certain that some propylene glycol is a good thing. The oil vapes much better when diluted and PG is nothing to worry about, it is in many health, cosmetic and food products. It has many uses. It’s a solvent, humectant (keeps things moist), preservative and it helps absorption of some products. It is non-toxic.
There is further development work to be done. I believe there is a ‘sweet spot’ for the correct amount of PG, probably around 20%. I also think the battery and cartridges can be improved, particularly for medical use. Once this is achieved, a product like this with perhaps a 60:40 THC:CBD ratio should form the basis of an application to the Medicines and Health products Regulatory Agency (MHRA) for a marketing authorisation. It will knock Sativex into a cocked hat. In fact, if GW Pharma aren’t investigating this already then they are failing in their duty to shareholders. I shall certainly be doing all I can to research and facilitate the funding to bring such a product to market.
Yes, this is the future of cannabis. Imagine the packaging, marketing and merchandising opportunities for the recreational market. Understand the overwhelming benefits of this as medicine against the raw, herbal product. Yes, I know some will object and the tired old hippy luddites will say it’s a sell out and many more Big Pharma conspiracy theories will emerge but this is the future. Remember you heard it here first.
Yet another cannabis petition amongst hundreds of similar pleas was filed earlier this autumn. This one though is more tightly focused on removing cannabis from schedule 1, which defines it as having no medicinal value. The petition is also commendably concise but characterises itself as a ‘demand‘ that cannabis be rescheduled, an unfortunate choice of words.
Nevertheless, congratulations are due in that it has exceeded the threshold of 10,000 signatures which means the government must respond. That response is now in and it is predictably dishonest, dismissive and authoritarian in its tone. The Home Office has responsibility for drugs policy so it has drafted the response but it surely must have consulted with the Department of Health.
In fact, I was told only this week by a senior minister that “… the search into the medicinal use of cannabis is something that falls within the jurisdiction of the Department of Health.” That may be a subtle shift in policy from which we can draw some hope. But I fear that the response to this petition offers no hope at all. It is stubborn, obstinate, inaccurate and in denial of evidence and experience.
To be clear, the Home Office has been systematically lying and misleading the British people about cannabis for at least 50 years. The Department of Health is timid on the issue, leaves the public statements to the Home Office heavies and seems more interested in generating fee income for the Medicines and Healthcare products Regulatory Agency (MHRA), than in actually treating patients effectively.
I analyse the response paragraph by paragraph.
“Herbal cannabis is listed in Schedule 1 as a drug with no recognised medicinal uses outside research. A substantial body of scientific evidence shows it is harmful and can damage human health.”
By far the majority of scientists and doctors now recognise that cannabis has real and significant medicinal uses. Of course it is possible that cannabis can cause harm, as can any substance. However, there is no scientific evidence that shows cannabis as being any more harmful than over-the-counter medicines or many common foods. Professor Les Iversen, chair of the Advisory Council on the Misuse of Drugs, is on the record saying: “cannabis is a safer drug than aspirin and can be used long term without serious side effects”.
“The Government will not encourage the use of a Schedule 1 controlled drug based on anecdotal evidence. It is important that a medicine is very thoroughly trialled to ensure it meets rigorous standards before being licensed and placed on the market so that doctors and patients are sure of its efficacy and safety. “
It is not the government’s role to encourage the use of any drug as medicine, that is the role of a doctor. Only by removing cannabis from schedule 1 can that decision be placed in doctors’ hands. There is a vast quantity of peer-reviewed, published scientific evidence on the medicinal use of cannabis including human clinical trials. It is false to suggest that only anecdotal evidence is available. See ‘Medicinal Cannabis: The Evidence’. Thousands of doctors and millions of patients are sure of the efficacy and safety of cannabis based on existing research, trials and experience. Many commonly prescribed medicines have nowhere near as much evidence behind them as cannabis.
“Cannabis in its raw form (herbal cannabis) is not recognised as having any medicinal purposes in the UK. There is already a clear regime in place to enable medicines (including those containing controlled drugs) to be developed and subsequently prescribed and supplied to patients via healthcare professionals. This regime is administered by the Medicines and Healthcare products Regulatory Agency (MHRA), which issues Marketing Authorisations for drugs that have been tried and tested for their safety and efficacy as medicines in the UK.”
The lack of recognition for the medicinal purposes of cannabis is a grave error with no evidence that supports it. Cannabis is a traditional medicine which recorded history shows has been used safely and effectively for at least 5,000 years. The only thing that stands in the way of cannabis being prescribed by doctors is its schedule 1 status. The MHRA is a diversion and is irrelevant. It exists to trial and regulate new medicines and requires a £100,000 application fee before very costly clinical trials take place. This is an unnecessary obstacle to a traditional medicine which contains more than 400 compounds. The MHRA process is designed for potentially dangerous, single molecule drugs and is not applicable to cannabis.
“It is up to organisations to apply for Marketing Authorisation for products that they believe have potential medicinal purposes so that these can be subject to the same stringent regime and requirements that all medicines in the UK are subjected to.”
Many substances and drugs which have medicinal purposes are regulated either as Traditional Herbal Products or food supplements. It is the schedule 1 status of cannabis which prevents it being regulated and controlled in this way which is far more appropriate given its very low potential for harm and the very wide range of conditions for which it can be useful.
“Since 2010 UK patients can use the cannabis-based medicine ‘Sativex’ for the treatment of spasticity due to multiple sclerosis. ‘Sativex’ can also be prescribed for other conditions at the prescribing doctor’s risk. ‘Sativex’ was rigorously tested for its safety and efficacy before receiving approval, and is distinguished from cannabis in its raw form. It is a spray which is standardised in composition, formulation and dose and developed to provide medicinal benefits without a psychoactive effect. Due to its low psychoactive profile ‘Sativex’ was rescheduled from Schedule 1 and placed in Schedule 4 Part 1 to enable its availability for use in healthcare in the UK.”
Sativex is a massively expensive form of cannabis oil which is not prescribed because of its cost. It is at least 10 times the price of Bedrocan medicinal cannabis as regulated by the Netherlands government which could be immediately made available in the UK. It is a deliberate falsehood to claim that Sativex does not have a psychoactive effect. The statutory document ‘Summary of Product Characteristics’ describes “euphoric mood” as a “common” side effect. The scheduling of Sativex in schedule 4 is a deception requiring 75 words falsely to distinguish it from other forms of cannabis whereas every other drug in every other schedule requires just one word.
“The MHRA is open to considering marketing approval applications for other medicinal cannabis products should a product be developed. As happened in the case of ‘Sativex’, the Home Office will also consider issuing a licence to enable trials of new medicines to take place under the appropriate ethical approvals. “
Cannabis, which contains 400 + compounds is not suitable for MHRA regulation which is designed for single molecule drugs which are potentially dangerous. There is no significant danger from the use of cannabis when prescribed by a doctor. This is already well established in scientific evidence and the referral to the MHRA is a diversion and an excuse for failing simply to put the decision in doctors’ hands.
“In view of the potential harms associated with the use of cannabis in its raw form and the availability of avenues for medicinal development, the Government does not consider it appropriate to make changes to the control status of raw or herbal cannabis. “
The government has offered no evidence of the potential harms to which it gives such weight. No “development” of cannabis is required. It is a traditional medicine consisting of the dried flowers of the cannabis plant.
“The Government’s view is that the Misuse of Drugs Act 1971 and regulations made under the Act continue to facilitate the development of medicines which are made from Schedule 1 controlled drugs. The legislation is aimed at protecting the public from the potential harms of drugs and is not an impediment to research into these drugs or development of medicines.”
The government’s view is intransigent and as demonstrated by this response is ignorant of the available evidence. This response reinforces the government’s clear intention not to consider the evidence and simply to deny it. The evidence shows that the potential harms of cannabis as medicine are trivial and inconsequential. If its schedule 1 status was not an impediment to research, there would already be a great deal more research into cannabis as medicine.
“In 2013 the Home Office undertook a scoping exercise targeted at a cross-section of the scientific community, including the main research bodies, in response to concerns from a limited number of research professionals that Schedule 1 status was generally impeding research into new drugs.
Our analysis of the responses confirmed a high level of interest, both generally and at institution level, in Schedule 1 research. However, the responses did not support the view that Schedule 1 controlled drug status impedes research in this area. While the responses confirmed Home Office licensing costs and requirements form part of a number of issues which influence decisions to undertake research in this area, ethics approval was identified as the key consideration, while the next most important consideration was the availability of funding.”
The Home Office is entirely untrustworthy and dishonest on anything to do with cannabis. Researchers, scientists, doctors and those already using cannabis as medicine simply do not trust anything it says on the subject based on long experience of its calculated dishonesty and misinformation.