Cannabis treatment concerns

Cannabis oil treatment has been approved for Alex Renton after having a severe seizure and a subsequent two month coma.

Cautious concerns have been expressed by experts about the cannabis product approved as it is virtually untested in this situation, and it has more of an industrial background than a medical background.

One expert says “this is uncharted territory”

The biggest concern is for Alex’swell being, and whether any cannabis oil treatment will help him. We have to hope.

It will have been an awful and very stressful time for Alex’s mother (and sister). Any mother in her position would be desperate for something to help her son. She has pushed hard for approval for alternate treatment, as nothing the hospital could do seems to have worked.

But what is going to be tried now has virtually been untested, and some concerns have been expressed about the particular product that has been chosen and approved. It’s a risk – but any new treatment would be a risk, and doing nothing would also be a major risk.

There’s been a post on this at the Science media Centre: Cannabidiol as a seizure treatment – Expert reaction where they ask:

Health authorities have approved the use of hemp derived medication Elixinol – on a one-off basis – to treat a coma patient suffering ongoing seizures. But does it work?

I don’t think anyone knows whether it will work.

The drug was approved on compassionate grounds by Associate Minister of Health Hon Peter Dunne, to be administered by clinicians treating Wellington patient Alex Renton.

The Minister said that  “despite the absence of clinical evidence supporting the efficacy of CBD in patients with Mr Renton’s condition status epilepticus, my decision relies on the dire circumstances and extreme severity of Mr Renton’s individual case”.

The Science Media Centre contacted New Zealand experts for comment.

There is a lot of interest in what is happening with Alex and whether cannabis products will help or not.

Dr John Ashton, Senior Lecturer, Department of Pharmacology and Toxicology, University of Otago, comments:

“There is some evidence that enriched CBD oil may help reduce seizures in specific kinds of hard-to-treat childhood epilepsy, but much of this evidence is anecdotal, and relies on parental reports. Controlled experiments have yet to be completed, though one product “Epidiolex” which is 98% CBD and produced by GWPharmaceuticals (who also make Sativex) is showing promising interim results in an ongoing experiment.

“However, there is no evidence that CBD can treat status epilepticus nor encephalitis, so this is uncharted territory. Also, the product Elixinol is an industrial hemp oil product, not from medicinal cannabis; hemp and medicinal cannabis are distinct variants of the same species. Elixinol only has 18-19% CBD, and contains a range of other compounds, and has not been tested in any kind of seizures under controlled conditions.”

So there is no evidence that the product, Elixinol, has had any beneficial effect for the type of seizure Alex has had. A significantly different product, Epidiolex, “is showing promising interim results in an ongoing experiment”.

Assoc Prof Michelle Glass, Head – Department of Pharmacology, University of Auckland, comments:

“The reports that we have seen in the media today strongly imply that the government has approved cannabis for the treatment of Alex Renton, it is important that people recognise that this is not the case.  What has been approved is oil made from industrial hemp, which is not marijuana, it is not a drug that will make the user experience any of the “high” generally associated with cannabis based products.  Instead, these are plants with a very high fibre content and a negligible THC content (less than 0.2%).  THC is the component of cannabis that generates a high.

“The use of high cannabidiol (CBD)  strains of cannabis or hemp have recently garnered a lot of public attention, particularly in pediatric seizure disorders such as Dravets syndrome, where there have been some dramatic results in individual patients (see the media coverage around Charlottes Web).  The strength of these individual results was such that the FDA awarded a pharmaceutical preparation of CBD – Epidiolex (from GW pharmaceuticals) orphan drug status, helping to drive the progress of clinical testing.

“These larger scale clinical trials are currently underway, and early reporting of the initial results looks very promising, with good seizure control being achieved and the drug being well tolerated, but it’s important to note that these are still in quite low numbers of patients (around 150) and a limited number of seizure disorders, meaning it is difficult to generalise at this stage.

“The compound that has been approved for Alex Renton is not Epidiolex which is a pure 98% CBD oil – but Elixinol, this is reported on the manufacturers web site to be 18% CBD hemp oil, which to the best of my knowledge has never been tested in clinical trials – however, there are some anecdotal reports of similar products proving useful in seizure disorders.  There is even a suggestion from animal studies that less pure products with a range of plant based cannabinoids in them might be preferable to a highly pure product.

“This is really a tragic case, and given that this is a compound which appears to be well tolerated, it is certainly worth a try, we can only hope in the future that there will be stronger clinical evidence as to what composition and dose of medicine is most likely to succeed.”

So the use of CBD for Alex looks like a bit of a medical punt.

And the particular product approved is also a punt.

As nothing else has worked for Alex then trying anything is probably better than nothing, as long as the risks are relatively low and that would seem to be the case here.

If Elixinol works and Alex’s condition improves that would be great, but there will be no way of knowing whether it was the best product to use or not. A different cannabinoid may have had more or less effect. There’s little way of knowing.

Epidiolexis mentioned above.

If there is no improvement then it will leave many questions unanswered. It wouldn’t prove that Elixinol was ineffective in general as it’s possible Alex’s condition is simply untreatable. And it wouldn’t prove that cannabinoids wouldn’t help Alex.

If Elixinol has no effect on Alex, or has little effect, then perhaps an alternative like Epidiolex could be tried to see if it is more effective for him.

Another product that’s been suggested is from StateWide Dosed Medicines.

This all seems like hit or miss experimentation, and that’s pretty much what it is. Nothing else has worked for Alex so there seems little to lose – CBD could have an adverse effect but so could any other treatment.

It seems to be a risk worth taking – if Alex was my son I’d want to try anything that gave me hope of success.

I hope that the medical advice behind the decision to try Elixinol is sound – there are criticisms of this product online.

And I hope Alex gets better. It would be a major for him and his family, obviously. It would also be significant in the use of CBD as a treatment for seizures.

Leave a comment

3 Comments

  1. When I did my blog post on Sativex, and can we do better, I had no idea about statewide collective, they are a perfect example of what may be possible.

    As for Elixinol, its not even Medical Cannabis, its industrial hemp. Its legal at the federal level so its no big deal. As a hemp derivative, which are low in cannabinoids naturally, mountains of hemp fibre is needed for extraction, from a plant known for its ability to leech toxic materials such as heavy metals from the soil… so there is concern there, as adverse events have been reported in the past, both in Australia and the US. And the company that owns Elixinol LLC is known for dodgy dealings in the USA to boot.

    Reply
  2. Well said Shane.. we need to move past this over-exaggerated hysteria around ‘medical marijuana’.. Elixinol is NOT ‘Marijuana’ (slang name). Stated clearly on their website. Its a Hemp extract.
    Hemp is legal to grow here in Aotearoa/NZ, why are they making such a big deal of this ?
    Cannabis is a class C drug, why are they making it sound like its ‘Super A’ (more harmful & addictive than morphine) !

    not wishing to sound like a ‘stuck record’; NZ is really ‘dragging the chain’
    Elixinol is available in all 50 USA states WITHOUT a prescription, as a Dietary Supplement :/

    Reply

Leave a Reply to Zedd Cancel reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: