Why are we running clinical trials for medicinal cannabis? The ancient Chinese used it. So did the Egyptians, Romans, and the Greeks. We've been using it for thousands of years. That’s a long, long time to get to know something we’ve smoked or eaten daily.
Given human’s recreational experience with cannabis, why are the Australian and other governments insisting on clinical trials before they register medicinal cannabis products? Well, it turns out that there is still a huge amount we don’t know about it as a medicine.
In Australia particularly, it comes down to the government holding cannabis to the same standards that it holds every other medicine, meaning there needs to be robust evidence for cannabis for each specific disease and condition, that there needs to be an optimised formulation, and it must be shown to be as good, or better, than current treatments.
What are clinical trials?
Clinical trials are research experiments on new medicines we undertake on humans to answer three specific questions:
- Is it safe?
- Does it work?
- Is it better?
There are three phases to clinical trials, with each phase focusing on answering one of those questions. At any time, anyone can log into the Australian New Zealand Clinical Trials Registry to see what trials are being undertaken.
Australia’s experience with cannabis means we already know the answer to the first question: Is it safe? The short and long-term side effects of cannabis are well documented. As such, no one is really running Phase I trials in Australia for cannabis. But while we can skip over that step, safety data will still be compiled in other phases of clinical trials because there is some information we are missing, such as, can taking cannabis affect the efficacy and safety of other medicines?
Does it work?
So, phase II (Does it work?) is really where we are starting our clinical trials. Now, you may think we could skip over this step as well given what we know from recreational use; good for pain, helps with seizures, gives you the munchies so good for people with low appetite due to cancer chemotherapy.
But not so fast.
There is a saying in science that goes: the plural of anecdote is not data. That is, the results for a few people aren’t transferable to a whole population of people. Let’s take cannabis for pain as an example.
If you broadly ask, is cannabis good for pain, then the broad answer is yes. But the important question is, for what types of pain? Does it work for acute pain, like you’ve just accidentally cut off your hand? Probably not, but we don’t know for sure yet.
Or does cannabis work for all types of chronic pains, like arthritis, lower back pain, cancer pain, and so on? Chances are cannabis works better for some types of pain and less well for others. We can’t just lump all types of pain together and make a broad decision. We need to run trials and make a pain-by-pain decision on whether it works. And right now, we don’t have that information.
Tied with gaining efficacy data, is also the need to know what type of cannabis, how much, and when we need to take it for each condition. Let’s say we want to use cannabis for arthritis. How much cannabidiol(CBD) do you need; 10 milligrams, 100 milligrams, 1000 milligrams?
And what about tetrahydrocannabinol? Should there be none at all or does a small amount of it work synergistically with the CBD? And should the cannabis be in a capsule form, as an oil in a dropper bottle, or should it be inhaled? Because each of those formulations will be absorbed at different rates by the human body which will affect its efficacy.
Finally, how often should you take it? Once a day, twice a day, or whenever you need it? And should it be taken with or without food? These factors also affect efficacy.
When a decision is made about whether cannabis works for a particular condition, that is linked to the specific formulation and dosing schedule that was used in the clinical trial. Change for the formulation or the dose and you could change the efficacy.
Is it better?
Phase III trials deal with whether a medicine is better than the current treatments.
Let’s say we’ve decided that cannabis works really well for arthritis, and we know the dose and delivery method that works best. Now we need to know whether it works worse, the same, or better than other pain killers. Is it better than paracetamol or ibuprofen? Is it better than opioid-based pain killers?
And not only that but is it safer or more dangerous than the alternatives? Maybe it turns out cannabis is as not as effective as opioids and but it’s safer. Or maybe cannabis turns out to be more effective than paracetamol, but not as safe. With phase III data we can do a cost-benefit analysis where we tally up the efficacy of cannabis against its side effects for different conditions and make a decision as to whether it should be used.
What can Canngea do?
Canngea is a business-to-business manufacturer of medicinal cannabis in Australia. As well as white-label supply of pharmaceutical products, we can also assist in the design and supply of medicinal cannabis products for clinical trials. Canngea can help with the design of clinical trial protocols, patient consent and information sheets, trial registration, and ethics applications. Once you have your clinical trial data we can also assist companies with applications to list their product on the Australian Register of Therapeutic Goods and with Pharmaceutical Benefits Scheme applications.
