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Pain management

The bar must not be lowered for medical cannabis

There have been calls to loosen regulations around medical cannabis to increase access for those who need it, but the government must resist and view cannabis with the same scrutiny as any other new medicine.

cannabis euopa conference

Source: Nigel Praities / The Pharmaceutical Journal

Calls have been made to lower the regulatory bar for medical cannabis, but this represents a slippery slope that we all must be wary of

It was a very smart event, held in an auditorium on the south bank of the Thames, within sight of the Houses of Parliament. In a packed hall, a few thousand young industry executives in suits typed furiously on their tablets, watched a series of presenters — including well-known politicians and the Maltese prime minister — and then later networked over poached salmon, chicken salad and sparkling wine.

One session even featured Sir Norman Lamb, a former health minister, sitting on a panel of experts chaired by the BBC’s Andrew Neil. Surrounded on stage by giant letters spelling out the words ‘Cannabis Europa’, Sir Norman called for looser regulation for medical cannabis products, arguing that “we will be waiting years” if the usual route of using clinical trial data is followed.

The conference was billed as the “arena to share knowledge and shape the future of medical cannabis in Europe”, held by companies “at the forefront of the cannabis industry”. It came to the UK eight months after the government was under intense scrutiny resulting from weeks of publicity around Charlotte Caldwell, who was barred from bringing cannabis oil into the UK to help her son with severe epilepsy.

Legalising the medical use of cannabis in November 2018 neutralised the media headlines but, since then, disquiet has grown about the lack of access to these treatments. The latest data show that only three NHS prescriptions were dispensed in January and February 2019.

The problem is that only specialist doctors can prescribe medical cannabis, and they have to do this as a ‘special’ medicine. Only one medical cannabis product is licensed in the UK and guidance from the National Institute for Health and Care Excellence on the use of medical cannabis will only be out in draft form later in July 2019. Right now, most of these specialists are not taking the risk of prescribing something they are not confident about, perhaps with good reason.

Exceptionalism for cannabis was a theme of the conference, but it represents a slippery slope for other illicit substances

But at the Cannabis Europa conference there were no such doubts. Sir Norman was met with a rapturous reception and, despite some tough questioning from Neil on his logic for lessening the burden of proof for medical cannabis, the audience was cheering from the rafters.

Sir Norman explained that, because cannabis is a plant, it cannot be studied in the same way as most medicines and that lowering the regulatory hurdles would enable many people to stop taking opiates — perhaps not recognising the irony that the opium poppy was not treated in the same way when new opioid products were introduced. He was supported by a fellow politician Crispin Blunt, Conservative Party MP for Reigate, Surrey, who told the conference that the UK needed a “specialist cannabis authority”, as they have in Germany.

This exceptionalism for cannabis was a theme of the conference, but it represents a slippery slope for the licensing of other illicit substances. It may take time, but it would be a mistake to lower the bar for medical cannabis products.

The legalisation of medical cannabis allows for better research and study of the benefits of this drug. However, as the chief medical officer for England has said, any medical product must prove itself through the usual regulatory routes. Companies must be willing to subject their products to rigorous clinical trials to ensure that prescribers have the confidence to prescribe it and that it provides the benefits that the manufacturers claim, without any significant risks.

To give credit to some industry bodies, a representative group called the Centre for Medicinal Cannabis announced a plan to push for targeted funding from the NHS and their own pockets to conduct clinical studies into the benefits of medical cannabis products in June 2019. The National Institute for Health Research, funded by the Department for Health and Social Care, has also put out two calls for trial funding.

Matt Hancock, secretary of state for health and social care, has asked NHS England to “rapidly” evaluate NHS prescribing of medical cannabis to “address barriers to clinically appropriate prescribing”, and this is welcome. But the government must resist any pressure to water down the requirements for licensing medical cannabis products and put patients, rather than politics, first.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206734

Readers' comments (2)

  • This is a misguided and deeply flawed editorial position which is extremely disappointing. One would have hoped for leadership from The Pharmaceutical Journal, not this miserable, poorly-thought through, evidence-free defence of the indefensible position of the medical establishment.

    Cannabis is not a "new" medicine. We know beyond doubt that it has been used as medicine for at least 5,000 years and that currently it is used regularly in its most potent, virtually unregulated, form as a recreational drug by around 250 million people worldwide. Given this history and current data on healthcare related to cannabis use we can say, beyond any reasonable doubt, that cannabis is safer even than most over-the-counter medicines.

    And cannabis is not a single pharmaceutical product. It is not one molecule but around 500 molecules, the most important of which can be provided in an innumerable number of permutations for different patients and conditions. Physicians all over the world are learning to prescribe specified ratios of THC, CBD and terpenes in response to the observed condition of a patient's endocannabinoid system. Sadly, this level of understanding is almost completely extinct in the UK and this editorial shows the appalling ignorance of cannabinoid science which i seriously letting patient's down.

    Regulatory hurdles do not need to be lowered but they most certainly do need to be changed and not in the cause of 'politics', the scurrilous claim made in this editorial but in the cause of patients. The current 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. It does not and cannot work for cannabis.

    In every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. 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.

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  • Context is seldom provided. How toxic is cannabis? It has an LD50 effectively of infinity. Yes, taking too much at once is very unpleasant but never fatal. In the UK, about 3000 people per year die from taking Asprin. Yes, cannabis can trigger a psychotic episode but it is an extremely rare event. Current research indicates that amongst regular users of cannabis, one in 23 000 experiences a psychotic episode in any given year. How does that stack up against alcohol? Psychiatric drugs? SSRIs? Cannabis is that lacking in toxicity and severe side effects that it does warrant less restrictive regulations than any of the licensed drugs that one can buy at a supermarket and certainly those that are dangerous enough to require a pharmacist to dispense them. It's not entirely benign, but peanuts, sesame seeds, eggs and Asprin kill people whereas cannabis does not.

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