What does the CBD down-scheduling mean?

6 minute read

It’s unclear whether the TGA move to make low-dose cannabidiol available over the counter constitutes progress or a ‘red herring’.

As this wretched year unfolded, so non-COVID health issues surged.

Cases of depression, anxiety, insomnia and loneliness have been rife, commensurate with the distressing and isolating times in which we live.

Speaking after COVID began its insidious influence on our lives, a professor of psychiatry at Melbourne’s St Vincent’s Hospital warned how the pandemic was responsible for rising anxiety.

“Goodness knows how many people I am seeing who are increasingly anxious and not able to sleep at night,” Professor David Castle told a conference.

Part of the answer, he suggested, could rest with cannabis, certainly for those where conventional medicine has failed to work.

While stressing it was not a panacea, he said the medical world needed to be open to the possibilities presented by this most divisive of plants.

Since then, the Therapeutic Goods Administration (TGA) has indicated that it will, indeed, adopt a more open attitude – at least towards low-dose cannabidiol, the non-psychoactive component of cannabis which, according to the limited data available, provides relief from anxiety, insomnia and pain.

By down-scheduling low-dose CBD – classified as 60 mg per day – to a schedule 3 medicine, it will, from June 2021, become available over the counter at pharmacies, without a prescription. Confirmation of September’s interim decision to down-schedule is expected later this month.

Yet beneath the simplistic CBD-for-all headlines that greeted the TGA’s announcement is a more uncertain and nuanced picture. For starters, there are serious question marks about the efficacy of CBD at such a low dose, something recognised in a TGA Safety Review.

But just as damaging to the credibility of the TGA’s motives is the suspicion that very few products will actually make it to pharmacy shelves in the first place. Under the current regulatory framework for most S3 drugs, manufacturers must list their medicine on the Australian Register of Therapeutic Goods (ARTG), a tall ask given efficacy is an evidentiary requirement for ARTG listing.

The medicinal cannabis industry has called the TGA’s apparently progressive move as a “red herring”, with one trade association branding it “politically expedient”.

Dr Vicki Kotsirilos, Australia’s first authorised prescriber of medicinal cannabis, told The Medical Republic there was “promising clinical evidence” and that she had patients who responded positively to even lower doses as a treatment of anxiety and for analgesia.

“For some patients even a few drops can be enough,” she said. “It’s not like pharmaceuticals where we can say this dosage will help for this condition. There is individual sensitivity to medicinal cannabis products, both for THC and CBD.”

But Dr Kotsirilos conceded that the sort of robust, high-quality data usually required for ARTG registration is lacking.

“If the TGA sets the bar high, sponsor companies may find it difficult to meet the efficacy requirements,” she said.

This lack of solid data is among the concerns for RACGP spokesperson Mark Morgan, a GP and Bond University professor. Should low-dose CBD find its way to market, it could simply add to the number of non-prescription “wellness” pharmacy products that provide negligible benefits.

“There are many things sold over the counter that we know have little or no value,” Professor Morgan said. “Pharmacists create a medical environment which confuses people as to whether they are buying evidence-based medicine or just something that has been marketed.”

Low-dose CBD would need to be “carefully monitored” to ensure it is not being sold for a “whole range of indications for which there is no evidence”, he added.

Yet of greater concern for Professor Morgan is how over-the-counter pharmacy medicines – of which CBD will be one – create disjointed healthcare where patients self-treat with products that may interfere with other medications.

“Over-the-counter medicines can lead to fragmentation of care,” he warned. “Seeking medical advice from multiple sources is always concerning. Patients’ confidence and comprehension declines. It’s far preferable for people to talk in detail to their GP and explore all the options before coming to a conclusion about what to try next and in what order to try and find solutions.

“I also don’t like the idea of turning common symptoms into something that needs medication. It’s not good for society or for people’s wallets.”

A change in lifestyle, rather than drugs, can often be the remedy, he said.

Professor Morgan’s concerns around care fragmentation were shared by Dr Kotsirilos, who argued the administering of medicinal products should be the left in the hands of GPs. Nevertheless, assuming pharmacy-only CBD is reliable, and the cost is reasonable, Dr Kotsirilos admitted she would advise patients with certain conditions to source their medication through the pharmacy.

The reason, she said, would be to avoid the Special Access Scheme (SAS), the laborious form-filling exercise required for a GP to prescribe cannabis.

“I would definitely save myself the time of doing the SAS application,” she said. “The time it take to fill out the forms, to offer a clinical justification, and possibly answer more questions from the TGA, is a barrier for GPs in prescribing medicinal cannabis. It’s an onerous administrative task.”

However, that approach does come with risk, albeit a calculated one. While stressing the importance of monitoring a patient taking pharmacy-bought CBD, Dr Kotsirilos acknowledged not everyone would return to their GP for supervision.

“If someone does purchase CBD over the counter, there is no guarantee they will return to see their doctor, so that monitoring may not happen,” she said. “It could be out of the GP’s hands and our control. That’s the main risk.”

An alternative scenario, one the medical cannabis industry is hoping for, is that growing demand for over-the-counter CBD may force doctors to expand their own knowledge.

Such a scenario is unlikely, according to Dr Jamie Rickcord, founder of Ananda Clinics in Byron Bay. He told TMR the relatively easy availability of CBD would further discourage already-sceptical GPs from exploring the use of medicinal cannabis.

“If a doctor who doesn’t know much about medicinal cannabis sees CBD available through a pharmacy, they’ll take the view of ‘why would I bother’?” he said. “They won’t feel the need to become educated, and won’t bother with the paperwork of the Special Access Scheme if people can buy it over the counter. They’ll just think the pharmacist can do it.”

But Professor Morgan and Dr Kotsirilos suggested the opposite could also happen: in the event of CBD products making it to market, GPs may feel compelled to enhance their knowledge.

“If a greater proportion of patients are telling their doctors they have found this treatment, and are describing the effects, I suspect most GPs would go ‘ok, this is something I need to know about’,” he said.

All of this, of course, presumes manufacturers successfully jump through the TGA’s various hoops and successfully register their products. And that is by no means certain.

Steve Jones is a journalist with Cannabiz, a media outlet specialising in the cannabis industry.

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