Dean Billington, chief operating officer at Brains Bioceutical, discusses the research behind medical cannabis and whether it can help tackle the UK’s chronic pain problem.
Globally, chronic pain is a major therapeutic challenge and affects more than 15% of the population. It is one of the most troubling and expensive issues for the NHS and patients. In fact, a recent study by The British Pain Society suggests that chronic pain affects more than 40 per cent of the UK population, meaning that more than 26 million people in the UK are living with pain that has lasted three months or longer. Writing in the BMJ, one study has suggested that this could rise to as high as 60 per cent among those over the age of 75.
For many patients battling this silent epidemic, it can be an exercise of jumping from one prescription to another and at a huge cost. The associated treatment for these patients is estimated to account for 4.6 million GP appointments each year, at a staggering cost of £69 million.
Unfortunately, treatment pathways have often directed patients to opioid painkillers. A review published by Public Health England revealed that the UK now has the fastest-growing rate of opioid use across the world, with prescriptions rising by 22 per cent over the past decade to 40 million prescriptions a year. This is despite NHS guidelines recommending that opioids should not be taken for more than a few weeks at a time to avoid the risk of addiction. In addition, health experts have warned that opioid painkillers are not effective for 90 per cent of people with chronic pain.
With the NHS now looking to move away from prescribing these addictive opioid or non-steroidal anti-inflammatory drugs (NSAIDs) – following updated draft guidance issued by NICE in August 2020 – many feel there is now an undeniable need for alternatives.
Cannabis as an alternative to opioids
In September 2020, Dr Steve Hajioff, a former chair of the British Medical Association, argued that cannabis should be made available legally using prescriptions to prevent patients turning to the black market for pain relief.
Evidence from clinical trials showed therapeutic benefits of cannabis, especially THC (delta-9-tetrahydrocannabinol) and other cannabinoids in reducing neuropathic pain intensity in various conditions.
In the United States, where cannabis has been made legal for medical purposes, prescriptions for opioids and anti-depressants have dropped by around 30 per cent. Data released by the US Government also suggested that prescribing cannabis medicines can also help prevent around 31 per cent of deaths linked to opioid addiction each year. A 2019 study published by the US journal Health Affairs found that more than 62 per cent of Americans who use medical cannabis did so to treat chronic pain.
Also in the US, a longitudinal analysis of the number of opioid prescriptions filled under Medicare Part D, found that when medical cannabis laws went into effect in a given US state, opioid prescriptions fell by 2.21 million daily doses filled per year. When medical cannabis dispensaries opened, prescriptions for opioids fell by 3.74 million daily doses per year. The reductions in daily opioid doses were particularly notable for hydrocodone (Vicodin) and morphine prescriptions.
It could be argued that the UK should also now consider the potential for cannabis medicines more seriously.
The medical cannabis sector in the UK
The UK has been slower than the US to embrace medical cannabis fully as a medicine. UK law was amended in November 2018 to allow specialist doctors to prescribe a range of cannabis based medicines to patients who might benefit from them. This amendment to the Misuse of Drugs Regulations 2001 (MDR 2001) was considered a landmark decision at the time.
There was wide pharmaceutical support in the lead up to the change in legalisation. In June 2018, results from a Royal Pharmaceutical Society (RPS) survey showed that over 80% of pharmacists agreed that cannabis should be rescheduled, and the three RPS national pharmacy boards signed a policy statement to the Home Office saying that this would give ‘pharmaceutical scientists greater freedom to research its potential medicinal uses and to carry out clinical trials’.
However, while there has been some support in the healthcare industry, very few prescriptions have been issued on the NHS. This may be partly due to a lack of awareness around cannabis based medicines available, but also due to the responsibility placed on doctors who elect to pursue this form of treatment. With the exception of Sativex, which is a fully licensed drug, all other cannabis based medicinal products (CBMPs) are unlicensed. Patients looking to qualify for medicinal cannabis need referral from their GP to a specialist clinician listed on the Specialist Register of the General Medical Council.
At the same time, a YouGov poll (commissioned from the Centre for Medicinal Cannabis in November 2019) suggested that around 1.4 million people in the UK regularly use cannabis illegally for medical reasons.
There are currently three cannabis medicines that have been through extensive clinical trials and are licensed in the UK to treat specific and rare conditions. Sativex can be prescribed to treat MS-related spasticity; Epidyolex has been approved by the EMA to treat seizures in patients with Lennox-Gastaut syndrome and Dravet Syndrome, and Nabilone can be used to treat chemotherapy induced nausea and vomiting where other treatments are not effective.
While the approval of these three medicines is undoubtedly a step in the right direction, they are expensive to access and only a limited number of prescriptions have been issued on the NHS to date.
Guidance from the National Institute for Health and Care Excellence (NICE) remains cautious and calls for more research and large-scale clinical trials. One to watch is Project Twenty21, launched in November 2019, which will see up to 20,000 patients trialing medical cannabis for various conditions including chronic pain, backed by the Royal College of Psychiatrists.
Other examples of research into the efficacy of cannabis include a preliminary study from the Dent Neurological Institute in Buffalo, New York, which suggested that cannabis medicines offered elderly patients relief from chronic pain and other ailments associated with the side effects of Parkinson’s disease and multiple sclerosis. A clinical review published in JAMA (2015) discussed the use of cannabinoids in the treatment of chronic pain associated with multiple sclerosis.
To ensure patients receive safe, consistent, pharmaceutical grade medical cannabis, there needs to be a wider education programme, and approved evidence base to help clinicians and pharmacists understand cannabis and cannabis-based medicinal products (CBMPs) to support prescriptions and funding decisions.
Pharmacists will be on the frontline of supplying cannabis-based medicinal products and in giving advice to patients on them as part of their treatment plan. It is essential that there is robust governance around prescribing and dispensing.
As the chronic pain problem in the UK continues to deepen and concerns of an opioid epidemic develops, evidence from international studies is being taken on board by some physicians, particularly those looking to issue unlicensed cannabis medicines. However, it is yet to go mainstream.
Continued research in the area will be needed over time to advance NICE guidelines, draw extensive conclusions, and create a climate whereby medical cannabis is accepted as a medicine for a variety of health conditions including chronic pain. It is only with a strong and regulated industry that we can help remove the remaining stigma around cannabis, produce high quality, consistent, refined products that help the nation with its chronic pain problem and ultimately improve the patient experience and access to medical cannabis.
There is a great deal that producers, pharmaceutical companies, the NHS, and the wider health ecosystem can learn from the experience accumulated to date. By collaborating, innovating and leading in a science-based understanding of the full impact of cannabis for the healthcare and wellness markets, the medical cannabis industry will not only look to provide solutions to today’s most pressing problems, but potentially even more complex ones in years to come.
Dean Billington is chief operating officer at Brains Bioceutical and is based in BSPG Laboratories, Kent, UK. The company produces natural CBD as an Active Pharmaceutical Ingredient (API) for pharmaceutical applications, research & development and clinical trials.