04 Sep Chemist + Druggist: A New Generation Of Drug

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Originally published in Chemist + Druggist, 3rd September 2014

By Annabelle Collins

Pressure is growing for the government to legalise and fund the use of medicinal cannabis. So how likely is it that cannabis-based medicines will become commonplace in UK dispensaries?

A few years ago, the idea of dispensing cannabis on the NHS seemed unthinkable. Although the pain-relieving properties of the class B drug have long been recognised, its use is banned even for medicinal purposes. But there is increasing pressure for the NHS to fund the new generation of cannabis-based medicines, which claims to have maximum patient benefits and minimal side effects.

The move seemed to gain ground last month, when Wales approved one of these medicines – Sativex – for use in multiple sclerosis (MS). The drug’s manufacturer is now keen to see the approval being extended to other countries and conditions. So could dispensing cannabinoids soon become a regular occurrence for pharmacies in the UK and what is the reasoning behind their use?

The pioneers

The American organisation Realm of Caring is frequently named as the pioneer in medical cannabis treatment. The company was founded last decade in Colorado, where the use of marijuana for medical purposes was legalised in 2000.

Founders the Stanley brothers became interested in the medical benefits of the drug after seeing that their cousin wasn’t helped by conventional pain relief. In 2009, they started growing cannabis plants that were high in the cannabidiol compound (CBD), which has medicinal properties, but low in the psychoactive compound tetrahydrocannabinol (THC).

A few years later, the brothers were approached by parents who were in despair over their young daughter Charlotte, who had Dravet Syndrome, a severe form of epilepsy. They felt CBD oil was her last chance for a normal life. The brothers provided Charlotte with the oil, which reduced her seizure rate from 300 a week to one or two a month, and named their high-CBD plants Charlotte’s Web in her honour.

These plants are now being used by about 400 families in the US to treat their children and there are more than 1,000 people on the waiting list.

“Our main goal is to get patients off the waiting list,” explains Graham Carlson, director of operations at Realm of Caring. Due to strict restrictions on cannabis research in the US over the past 50 years, he says, this is a very young area of science. However, this could all be set to change.

“We’re seeing a cultural shift on a broader scale at the moment,” says Mr Carlson. “We need to focus on legitimising the product. Cannabis is a touchy [subject] and parents feel they’re taking a risk, so we need to explore the safety and learn more about it.”

<>The cultural shift

Wales is one of the first countries to experience the “cultural shift” that Mr Carlson mentions. Last month, the All Wales Medicines Strategy Group approved Sativex to relieve the muscle spasms caused by MS, meaning the product can now be prescribed on the NHS. It is currently the only form of medical cannabis that can be prescribed in the UK.

Pharmacists seem to have accepted the move, if Sion Llewelyn, manager of Rowlands Pharmacy in the Welsh town of Bala, is anything to go by. Mr Llewelyn is willing to try anything that relieves his patients’ pain. “A patient here has MS and is suffering from a lot of pain, even though she has tried the other painkillers available. I looked at various options and Sativex seemed to offer the best relief. There is definitely a place for it,” he tells C+D.

Mr Llewelyn has no concerns over Sativex being made from cannabis. “I welcome it [the drug] very much,” he says. “It’s one more piece of ammunition to try to get the job done.”

The manufacturer of Sativex, GW Pharmaceuticals, is encouraged by the approval in Wales. The company is now conducting further research into its palliative potential and hopes to see its use widened.

“The company is evaluating the potential for cannabinoids in the treatment of Type 2 diabetes, ulcerative colitis and diseases such as epilepsy, schizophrenia and neurodegenerative diseases,” GW Pharmaceuticals spokesperson Mark Rogerson reveals.

“[Our] own specific research on CBD in epilepsy has been going on for about six years,” Mr Rogerson says. “It’s now in clinical evolution in both adult and paediatric patient populations in the US and we are looking to see how the trials programme can be developed in the UK.”

The cost factor

So could Sativex soon be commonplace in pharmacies across the border in England? There will certainly be hurdles to overcome. Sativex is not yet approved by Nice, which recommends treatments for NHS use in England, as it believes the drug is not cost effective.

Campaigners, however, believe the efficacy of Sativex is not in doubt and that only the cost is preventing its approval. Peter Reynolds, the leader of cannabis law reform group CLEAR, believes Sativex is simply deemed too expensive to be prescribed – at a cost of around £175 per bottle. It is now campaigning for an alternative medicine to be used.

“Our main thrust is to try to get the UK government to allow the importation of Bedrocan, which is a cannabis-based product produced by the Dutch,” Mr Reynolds says. “We have doctors who want to write prescriptions for it but have been refused.”

Nick Ellis, a member of CLEAR and a sufferer of ulcerative colitis, can personally testify to the potential benefits of such a move (see Case study, below). He says the palliative qualities of cannabis oil have significantly improved his quality of life. “I’m in chronic pain and, to relieve it, I use a high concentration of CBD oil,” he explains. “It’s been treating me very successfully and I’ve been taking it since January but, if I stop taking it, every single one of my symptoms returns.”

Mr Ellis believes the legal status of cannabis has caused it to be under-regulated and left “in the hands of criminals”. “We want it to be regulated by evidence and not bias,” he says.

The beginnings of change

There is a glimmer of hope for patients such as Mr Ellis, though. He believes the perception of medical cannabis is slowly changing across the western world, which could force England to rethink its position. “We do have a good chance of getting some medicinal access in the near future because of the tide that is rolling out across the world,” he argues.

Mr Ellis has even taken his argument to Westminster. This most recently involved a meeting with drugs minister and Liberal Democrat MP Norman Baker. “I was one of three on the medical users panel. We all had a chance to tell our story and it seemed like they were taking it on board,” he recalls.

Indeed, his argument does seem to be gathering ground. In July, Mr Baker told the United Patients Alliance, a campaign group calling for the legalisation of cannabis for medicinal purposes, that evidence of the drug’s benefits should be followed even if this resulted in controversial policy-making. Last month,

Mr Baker wrote to health minister Jeremy Hunt calling for a review of the medical properties of cannabis. The Liberal Democrat MP called for drug laws to be relaxed to enable its use in certain severe conditions, such as Crohn’s disease and epilepsy.

Mr Baker tells C+D that England should not assume it has “nothing to learn” from other countries in cannabis regulation (see Medical cannabis regulations around the world, left) and is looking into how the drug is managed internationally. He could face some stiff opposition from his colleagues, though, and Mr Baker says the government has “no plans to legalise cannabis”.

Harry Shapiro, spokesperson for UK charity Drugscope, says there is still a way to go before cannabis-based medicines become commonplace. “The issue for big pharma is that it costs millions to bring a new drug to market, so any company undertaking research and development has to be assured they are going to see a return on their investment,” Mr Shapiro says. “The issue is, are there applications for cannabis that are likely to produce better results than currently available treatments?”

<>So it seems it will be a while before pharmacists are routinely dispensing medicines such as Sativex in England. The end goal of normalising the medicinal properties of cannabis is in sight, though. The research being done by GW Pharmaceuticals could certainly lead to more cannabis-based medicines emerging in the market and Wales’ trailblazing position could encourage other countries to follow suit. But there are still cost and political barriers to overcome.

With these developments, perhaps the next decade could see cannabis taken out of the hands of criminals and into those of the scientists and people such as Nick Ellis, who have come to depend on its healing properties.

Case study

‘Cannabis has treated me very successfully’

Nick Ellis, patient and member of CLEAR

“I use a 30 per cent concentration of CBD to treat ulcerative colitis, which is a disease that causes bad inflammation of the bowels and the digestive system. I’ve been taking it since January and it’s treating me very successfully. My symptoms massively subside within a maximum of two days and sometimes within a couple of hours.

“I read through anecdotal evidence of CBD and I wasn’t expecting it to work as well as it did. I’m now a member of [cannabis law reform group] CLEAR so I’ve become knowledgeable in most areas of medicinal cannabis use.

“We [CLEAR] want to have a much safer and more regulated system surrounding cannabis. Because it’s illegal, it’s in the hands of criminals. There is no quality control. It’s also too expensive at the moment and the illegal market has caused that to happen. The more open the market is, hopefully the cheaper [medicinal cannabis] will get. We want regulated access for adults only, by evidence and not bias.

“I think people’s opinions on medicinal cannabis are getting more positive – people are waking up to the benefits – but there are a lot of scare stories going around. The more that ordinary people see the benefits, the more they will do their own research. The shift in opinion is slow but it is happening.”

Medical cannabis regulations around the world

UK: Sativex is currently the sole licensed cannabis-based medicine – in Wales only. Cannabis is a Class B drug and possession can result in prison or a fine.

US: 23 states and Washington DC have approved marijuana for medicinal purposes

Colorado: Cannabis was legalised in November 2012, but rules vary within the state’s municipalities.

Nevada: As of 2013, Nevada limited patients to 2.5oz of marijuana every 14 days. Patients must register for an ID card that permits medicinal use and renew their membership with a doctor’s approval every year.

Florida: A proposed medical marijuana amendment is currently being discussed.

Texas: Cannabis is illegal in Texas, even for medical uses, and can result in prison or a hefty fine.

Netherlands: Cannabis is legal. The Office for Medicinal Cannabis is the government office responsible for the production of cannabis for medicinal purposes and will provide it to pharmacies, universities and research institutes.

Spain: Cultivation of cannabis for personal use is legal. North-western province Catalonia is currently finalising plans to legalise medical marijuana.