“Media hype must be tempered by clinical evidence”


prescription pad doctor

Clinicians say they are cautious as demand for prescription cannabinoids outruns research on safety profile and effectiveness

Doctors have written to the Medical Journal of Australia (MJA) on behalf of the Royal Australasian College of Physicians (RACP), sharing their concerns that the introduction of medicinal cannabis has not followed the usual research-based safety and effectiveness processes.

While there is a growing community demand for prescription cannabinoids on compassionate grounds, the usual medical research standards have not yet been met, they say.

“While the RACP understands the community interest in cannabinoids as a therapeutic product, it emphasises that the usual regulatory processes designed to protect patients from serious harms are incomplete for medicinal cannabinoids, and that evidence for their effectiveness for many medical conditions is at present limited,” write Professor Jennifer Martin, Associate Professor Yvonne Bonomo and Clinical Associate Professor Adrian Reynolds.

“The Special Access Scheme (SAS) provides patient access to cannabis and other unregistered preparations on compassionate grounds without the usual quality and safety data requirements.”

The authors draw a comparison between medicinal cannabis and the introduction of opioid medicines.

“Treatment of persistent non-cancer pain with opioid medicines similarly began with little supportive evidence and has been associated with an epidemic of overdose deaths and poor pain outcomes, resulting in ongoing suffering.”

In an accompanying MJA narrative review, researchers from the Sydney Children’s Hospital and UNSW have reviewed use of cannabinoids for paediatric epilepsy.

They say anecdotal media reports of “miracle cures” have strongly influenced community perception, significantly affecting government policy and creating further complexity.

“High quality scientific evidence is essential to guide medical decision making and the political and legal framework,” says the research group led by Dr John Lawson, a paediatric neurologist and lead investigator in the NSW Ministry of Health-funded medicinal cannabis trials.

In regards to epilepsy, their narrative review found evidence for cannabis’ efficacy in treating the condition is limited but growing, with further clinical trials needed to clearly define efficacy and safety.

A 2017 randomised double-blind placebo-controlled trial of cannabidiol for drug-resistant epilepsy in children with Dravet syndrome found a median decrease of convulsive seizure frequency per month from 12.4 to 5.9 with cannabidiol, compared with from 14.9 to 14.1 with placebo.

However despite the positive results, the cannabidiol group experienced more frequent adverse events including vomiting, fever, illness, anorexia, seizures, sedation, diarrhoea and abnormal liver function test results, with 14.8% of the group withdrawing during the study period.

“There is a need for more scientific studies to understand the risk, benefits and reproducibility of cannabidiol in children with intractable epilepsy,” say the authors.

“The public perception and media hype must be tempered by clinical evidence.”

 

Confusion across the Pacific

Medicinal cannabis use in the US is also fraught with issues, and American physicians are similarly cautious about prescribing it as a treatment, despite cannabis having been legalised in several states.

A recent JAMA article shared survey results that revealed 30% of US clinicians had had patients or their families ask for medicinal cannabis at least once in the past month.

Seventy-nine percent of inquiries were to relieve nausea, 52% were for anorexia (appetite promotion), 26% were for pain, and 24% were for depression or anxiety.

Of all inquiries, only 14% of clinicians had actually facilitated access to medicinal cannabis.

Lead researcher Dr Joanne Wolfe, director of Paediatric Palliative Care at Boston Children’s Hospital, theorised that clinicians who are eligible to certify patients may have more understanding of the medicinal cannabis program in their state – including its nuances and clinical uncertainties – and therefore may be more cautious.

Despite legalisation in many states, cannabis remains classified as a schedule I controlled substance (considered to have a high potential for abuse and to be without medical value) by the Drug Enforcement Administration in the US, making it illegal under federal law.

Many American clinicians are unclear that it is actually against US federal laws to certify patients for medicinal cannabis treatment.

For nearly half the clinicians surveyed, the greatest barrier to recommending medical cannabis was lack of information surrounding formulation, potency and dosing.

Stefan Friedrichsdorf, medical director of the Department of Pain Medicine at Children’s Minnesota in Minneapolis, says he has chosen not to become a certifying physician due to the “unknowns”.

“I’m absolutely certain that there are very useful and good components in this compound, but we have to find out which ones and the safety profile,” he says.

“And with the current system, I have no control. I would certify it, and then my patients would go to a [dispensary] that has nothing to do with me, yet decides which brand to give, which strain to give, whether to go up or down in dosage.”

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14 Comments

  1. Joe Strummer
    19/02/2018

    There is always an element of uncertainty with any drug for a specific individual; its always a question of probabilities. Cannabis has been used for medical purposes for over 2,500 years. If people are fully briefed, accept the potential issues, approach the medication cautiously with appropriate support, and obtain the medication thru prescription, then is the level of caution applied to synthetic drugs warranted? Or are we denying a treatment that would assist, not all, but a significant number of patients? The patient will ultimately determine for themselves whether they benefit or not; plenty of people have been prescribed synthetic drugs which have had a terrible effect on them, its difficult to see mc could be as bad as some. But, the medical profession have been placed in a very difficult position here as they do not have the usual legal protections and information afforded them by clinical studies, which are certainly necessary for synthetic drugs. As one cannot overdose, or become physically addicted, perhaps this issue needs to be approached somewhat differently, with the patient knowingly taking a bit more responsibility; perhaps a limited legal waiver?

  2. Ricky
    20/02/2018

    “The authors draw a comparison between medicinal cannabis and the introduction of opioid medicines.

    “Treatment of persistent non-cancer pain with opioid medicines similarly began
    with little supportive evidence and has been associated with an epidemic
    of overdose deaths and poor pain outcomes, resulting in ongoing
    suffering.”

    Pathetic. Please stop comparing non-toxic cannabis to a very deadly pHARMa drug. It cheapens your already weak argument. pHARMa drugs kill by the score.

    • Jarrod McMaugh
      20/02/2018

      It’s interesting that you would focus on this point, since it is actually being used as an argument to lighten people’s perception of medicinal cannabis.

      Perhaps you’re bias prevents you from reading the article in context?

      • Ricky
        20/02/2018

        I don’t read it that way.

        Perhaps you’re bias prevents you from reading the article in context?

        • Jarrod McMaugh
          20/02/2018

          My bias is for the legalisation and improved access to medicinal cannabis, so… no

          • Ricky
            21/02/2018

            Please. Explain to me how comparing cannabis to synthetic heroin without noting that one is deadly while the other is not, is promoting cannabis?

            Every cannabis reference in this article makes it sound potentially dangerous and the CBD study reference was abhorrent. The author must have found the worst study results on the subject available. There are many CBD epilepsy studies available.

            Maybe you just don’t know any better.

            I’ll be waiting for you to explain how anything in this article was pro cannabis?

          • Jarrod McMaugh
            21/02/2018

            Well, the first thing I’ll point out is that heroin is synthetic; I’m not if you are implying that other opioids are worse because they are synthetic version of the one opioid everyone fears the most, but whatever your point, it doesn’t really add to the discussion. I think most people can agree that opioids are very dangerous – whether used recreationally or medicinally.

            Secondly, an article covering a letter to a medical journal that calls for restraint will of course discuss the citations used to justify this restraint. That would tend to make a lot of sense, since it is in fact the purpose of this article.

            Yes, there are many studies available on the use of CBD. Many of them are promising. Many of them don’t have the level of evidence that would normally follow for any other medication being introduced to clinicians for therapeutic use. This is, of course, the point of the original letter that this article is discussing.

            So far, all I’ve done is address the points you’ve raised that I don’t agree with, so I’ll answer your question to me, and also your original post.

            I pointed out that I thought the one quote you drew from the article to focus on was the one point that could be taken as a reason to consider medicinal cannabis. The rest of the issues raised in the original letter are not supportive, and question the validity of CBD as an intervention given the high rate of side effects and trial dropout, despite the significant impact. It also focuses on regulatory issues that aren’t specifically relevant to Australia (although similar), although they do explain the relatively low level of post-marketing data available.

            I say that this one quote is the only argument that is likely to lighten people’s perceptions on the medical use of CBD because for those clinicians who are in two minds, the comparison of CBD – which has a particularly low rate of mortality and a fairly tolerable level of morbidity – to opioids (which has high mortality and morbidity) is a disingenuous comparison for the original authors of the letter to make.

            The reality is, there will be three types of response to this article; those who think that cannabis is bullshit will continue to think so, or not even read these types of articles at all. Those who identify themselves as “Kevin Smith Fans” or are similarly at this spectrum on the CBD cheer squad will also find little in these kinds of articles that will sway them (although it might trigger them I guess). For those in between who are open to considering the pros and cons, this article may push them to read more, ask more questions, and form their own opinion. For that reason, reminding health professionals of the impact opioids have had on society is a positive step, because it’s a motivation to do better.

          • Ricky
            21/02/2018

            Btw, in the US real heroin kills a fraction of what pharmaceuticals kill. How you doing down under?

          • Ricky
            21/02/2018

            You never did clarify how this is a pro cannabis piece? Maybe because you can’t.

          • Ricky
            21/02/2018

            The real reality is, Jarrod, you seem to think everyone who reads this ‘story’ is as ignorant on the subject of cannabis and CBD as you and the author are. I am not. I have actually read nearly every published study on cannabis for the last 6 years. Not just on cbd, but thc as well, both synthetic and phyto. Do you know what that means? How many have you read?

            You suggested in your last post that CBD has killed people. Who? Where? When? CBD is a non-toxic derivative of the cannabis/hemp plant. A plant that has never killed anyone, ever. CBD doesn’t get you high and has no addiction potential. It’s a nutritional supplement.

          • Ricky
            21/02/2018

            Why are you editing my comments Jarrod? Why are divulging my personal info, Jarrod? Is this what ajp encourages? I’m positive disqus does not.

          • meganhps
            21/02/2018

            Hello, Ricky. Jarrod is not editing your comments, I am. Your personal information has not been divulged.

            We do not permit name-calling and personal attacks on our journalists or commenters. AJP is a site for health professionals. Please post accordingly.

          • Ricky
            21/02/2018

            Saying someone is ignorant of a subject is not name calling.

            Every post he made in response to mine was snide, but that’s acceptable?

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