In this episode, Dr Janet Schloss returns to FX Medicine to discuss her clinical trial researching the effects of medicinal cannabis glioblastoma multiforme, a particularly aggressive type of brain cancer with a low survival rate.
With incidences of glioblastoma multiforme on the rise in Australia and across the world, Janet talks about the vast potential for medicinal cannabis in the treatment of this condition.
Covered in this episode
[00:40] Welcoming back Dr Janet Schloss
[01:27] What is glioblastoma multiforme (GBM)?
[02:20] Prevalence and causes of GBM in Australia and causes
[05:32] Introducing the premise of Janet’s trial: treating GBM with medicinal cannabis
[07:38] Standard treatment for GBM
[09:59] Discussing Dr Charlie Teo’s involvement in the trial
[11:54] Quality of life effects seen in the trial
[14:28] Number of people in the trial
[15:30] Response from the medical community
[16:42] Does cannabis increase tumour size?
[18:19] Form of cannabis used in the trial
[20:09] Results in patients experiencing seizures
[21:41] Side effects
[23:25] Tolerability and compliance
[24:52] Cannabis as a supportive treatment
[25:57] Taking the trial into the future
[28:39] Educating the medical profession and hinderances to accessibility
[31:43] Hopes for the future of patients with GBM
[33:10] Standardising cannabis
[35:16] Completion of the trial
Andrew: This is FX Medicine, I'm Andrew Whitfield-Cook. Joining us on the line today is Dr Janet Schloss, who's been working as a naturopath and clinical nutritionist in her own practice for over 20 years. During this time she undertook further studies to complete her PhD in medical research in the School of Medicine at the University of Queensland. Dr. Schloss works currently part-time as Clinical Trials Manager in the Office of Research, Endeavour College of Natural Health conducting clinical trials and other research. The other part of her working career she devotes to seeing patients, the majority of whom have cancer and require supportive care. Welcome back to FX Medicine. Janet, how are you?
Janet: I'm great, Andy. Thank you so much for having me.
Andrew: Now today we're talking about a clinical trial that you're involved with, so we have to be secretive about certain parts. You're involved with a certain type of therapy with glioblastoma multiforme. And I think first we need to go back and have a definition. What is GBM?
Janet: So glioblastoma multiforme, or GBM, is probably...well, it actually is the most aggressive brain tumour that's around. And what it is is that it can actually start from just normal brain tissues or from another form of astrocytoma, which is a particular brain cell. And you can actually have a grade I to III anaplastic astrocytoma, which can then progress and turn into glioblastoma multiforme.
So in Australia we have approximately 2,000 diagnoses of brain tumours every year. They say originally it was 15% of those were GBM in Australia. Normally there's over 2,000 brain cancer diagnoses per year, in Australia we have around 1,000 diagnoses of GBM yearly.
Andrew: Why such a huge prevalence?
Janet: We're not really sure. They have actually seen an increase over the years. You know, brain tumour is not one of the big cancers, it's not breast cancer, it's not prostate cancer, but the increase is exponential. And they're still really unsure of what actually causes it. You know, they do think that there's some form of genetic involvement, there are certain diseases that may be, like, related to it, like neurofibromatosis, sorry. Some say that radiation to the brain at some stage may actually increase the risk of it. But one of the big things at the moment that they're saying that it may potentially be the result of it is electromagnetic fields, so EMF.
Andrew: That was going to be the big elephant in the room I wanted to address.
Janet: Yes, it is, and absolutely. You know, I think more research is actually required, but a lot of the environmental sciences are now definitely linking EMF to the increase of amount of brain tumours we have seen.
Andrew: Right. And I also remember, although I don't know about the type of cancer this was, but I thought I saw a paper some years back, and it was based at Royal Brisbane Hospital, I thought, an oncologist saying that there was a heck of a lot more parietal tumours being detected.
Andrew: Is that right?
Janet: That is correct, absolutely. And, you know, we obviously would be looking at the brain, depending on where the tumour is depends on what actually gets affected. But they have seen an increase in parietal tumours, which is interesting, which I still think is actually related to EMF.
Andrew: And also teens were presenting a lot more than adults, is that correct?
Janet: Yes, absolutely. So the increase of paediatric brain tumours is huge, you know. And we originally put it down to, you know, phones up to your ears and music uploads. But we've seen a huge increase in technology, and especially from a young age.
Andrew: There's a high prevalence of GBM in infants and young children which aren't necessarily the users of mobile phones, you know, ostensibly the culprit of the EMF. How is that answered, like what are people look at there, genetics?
Janet: It's actually quite interesting because GBM is normally an older person's disease, it's not necessarily a paediatric...
Andrew: Oh, okay.
Janet: ...disease. When we say for "young people," what I'm probably talking about for GBM are kids from 15 upwards. So it's, like I said, most of the GBM is primarily in adults, not necessarily actually in kids.
Janet: A rare...like, a rare event will actually be in children, but it's primarily brain tumours in adults.
Janet: Okay, so what we're looking at is medicinal cannabis in assisting people with glioblastomas. So we're doing two trials looking at tolerability and quality of life for people who have actually been diagnosed with glioblastoma or recurrent high-grade glioma, which includes some of the AA3s, anaplastic astrocytoma grade III. And basically we're having a secondary outcome of efficacy to see if it actually works in conjunction with standard treatment, or in some people's cases with no standard treatment because they're past that, to reduce tumour size, or help keep it stable.
Andrew: Right, okay.
Janet: So that's a very quick overview of this, of what the trial is about. But we have specific medicinal cannabis that we had made for the trial to do a randomisation of these two different ratios of 1:1 or 1:4, and looking at around 82 patients.
Andrew: When you're talking about the 1:1, 1:4, that's THC to CBD?
Andrew: Is that correct? So the 1:4 is more CBD than THC?
Janet: No, the 1:4 is more THC. So tetrahydrocannabinol is the part that can have some of the pyschoactivity and has most of the side effects. You know, all side effects related to medicinal cannabis is related to THC. You would need over like 600 milligrams per day of CBD to get any form of side effect, which is a huge dose. But no, what we're actually looking at as a 1:1 is around 6 milligrams of both THC and CBD. And the 4:1 is around 15 milligrams of THC to 3.8 milligrams of CBD.
Janet: Okay, so if possible they will try and debulk it. Because glioblastoma has, like, little tentacles, it's not what most people see as a round...lovely, round, solid tumour. It actually has little tentacles that go out from the main tumour. So a lot of the time they will try and remove as much as they can, so a debulking, if possible. Obviously where some of them are, they cannot actually surgically remove them. So then first-line treatment is radiotherapy and temozolomide, which is an oral chemotherapy. Because most of the chemotherapies don't cross the blood-brain barrier…
Janet: …so they usually take a daily low dose of temozolomide with radiation for about five weeks. They then have a break, and then they have six months to a year on a high-dose temozolomide per month.
Andrew: I know this is off track from the trial, but this is something I don't understand. If most chemotherapy doesn't cross the blood-brain barrier, the BBB, what's chemo brain? Is that based on just an inflammatory reaction in the whole body or is there certain, you know, metabolites or something that cross the BBB?
Janet: Yeah, I think there's still a lot more to look into the chemotherapy brain, which is a real thing. Originally they were just saying, you know, it's just due to stress and all that type of stuff, but that's not the case. I think that, again, similar to cancer, it's very multifactorial. I think that the pressure on the body and the stress on the body has an effect on the brain. I think there are certain nutrient deficiencies made possibly, as B12…
Janet: …that actually affect chemotherapy brain. I also think inflammation affects chemotherapy brain, as well.
Andrew: With regards to debulking, do they use neoadjuvant radiotherapy there to try and shrink the tumour at all or is it mainly surgery that's preferred?
Janet: So surgery will always be first call. If they can do surgery, they actually will. They're usually...even if they use radiotherapy, they usually don't do surgery afterwards, not with brain tumours, unlike other tumours within the actual body.
Andrew: Right. Okay.
Janet: Usually once you do radiotherapy, there is no surgical option unless there is another tumour form in a different area.
Janet: So it's being run out of the Prince Of Wales Hospital in Sydney, in Randwick. And Professor Charlie Teo is our Principal Investigator and it's run out of his clinical offices in Randwick.
Andrew: Now he's very famous for, you know, engaging with patients who are, let's say, refused surgery by other surgeons, and indeed by some he's called a cowboy. How is he involved with this, what's his experience with cannabis, what was he drawn to?
Janet: This is really interesting because my...you know, you always hear about him being a cowboy and stuff. And yes, he will actually take on, you know, other aspects which other people don't, but he really does care for people. And where we...this all came about because I was presenting at a medical conference that he was at, as well. We both presented around the same time and I came up and talked to him afterwards. And I discussed this concept of using medicinal cannabis for glioblastomas and he said, "Well, most of my patients are taking it anyway." I said...he said, "I'd really love to see clinical trials, let's do it."
Andrew: Okay, so anecdotally what was his viewpoint on the patients that had taken cannabis?
Janet: Yeah, he thought that they were getting benefits from it. So, which is where his interest actually lies. You know, anything that could, like in his …for brain cancer, foundational, the basis of it, anything that is a potential cure or assistance in helping these people is huge. You know, the prognosis for GBM is really horrible. You know, for most of them they only have a 12 to 15-month survival rate. You've got people, about 25%, lasting like up to a year. And the 5-year survival, which most people use as, you know, the big ideal, is 4.5%.
Andrew: When we're looking at quality of life, are we talking about just things like reduction of pain, reduction of stress, or are we talking about, hey, I'd love to say the word "restoration," but preservation of functioning, you know, lack of migraines, balance, fine-motor coordination? What are we looking at here with regards to QoL?
Janet: Yeah, absolutely, all the above. So what we're actually using is validated tests. So the quality of life instrument we're using is called a FACT-Br, the F-A-C-T-B-R, and it takes in conjunction all of those things that we just talked about. We're also doing a side effect profile. So we're using the cancer toxicity criteria through the National Cancer Institute of all the different aspects involved with people with cancer.
So what we've actually seen... And I can tell you this because we've actually completed 55 people in the trial so far and we've only got 9 more to complete which are now just starting and they should be completed by November, by the end of November. So I've done a little bit of analysis, general analysis, on it, on the quality of life, and at the moment we're seeing around a 12% to 13% increase in quality of life from the 12-week intervention that we're doing. And we've had statistical significance, and I would be interested to see what comes out at the end, for seizure management, for sleep…
Janet: …for pain, for nausea. But what I have seen anecdotally is also the increase in movement for people. So we've had a lot of people who haven't...who, from surgery, have had significant impairment. Someone maybe in a wheelchair is now able to actually stand and walk around her home…
Janet: …her speech hasn't increased as much. We've had a young guy who's like 22, 23 where his left side was quite impaired, with the cannabis he actually felt he could move his toes and have some movement within his leg. We had another lady who was also in a wheelchair actually gain more movement within her hand and was then able to start putting sentences together rather than just words.
Janet: So there's a number of different, you know, quality of life and life events that you can see a huge improvement with.
Andrew: Yeah. So when we're talking about this, you mention 12%. When you're looking at such a rare cancer and you're looking at a smaller group, how do you achieve statistically significance? Are you looking at 80, or, you know, 200 would really be something that you'd prefer? But then that's unfortunately a horrible diagnosis and you'd be following 200 people.
Janet: We could have easily had 200 people on this trial.
Andrew: Oh really?
Janet: Yeah. We had 900 people inquire, of which over 300 people qualified, and we could only take 82.
Andrew: So really this trial is really a proof of concept for a larger trial, yeah?
Janet: Absolutely, and that's what we're hoping to be able to do. You know, with this information, then we can be more precise in raising...doing a phase III trial, which I'm hoping to be multicentre, so all around the trade. Because one of the hard things only being in Sydney is that everybody had to fly into Sydney full time. And we've had people from Perth, from South Australia, from Melbourne, from Brisbane, from New Zealand, all of which fly in.
Janet: Yeah, so we've had a very mixed response from a lot of the medical fraternity. We've had a lot of people who are very interested and, you know, want to see what the outcome of this because they get a lot of questions. You know, there's a lot of stuff on the Internet and a lot of things that's out there saying, you know, cannabis can cure cancer and stuff like that, which has not been proved. So they want to have an answer to give to these patients who actually ask them about it. And they're very interested to see what the outcome is and we've had a number of them refer.
Then we've had people saying, "Well, until you run a phrase III trial, you know, I'm not going to really take notice." And then we've had other ones who blatantly say cannabis, like, creates or increases tumour growth and is really bad, and have really put us down. There's also so much information, I've had so many different people come back and tell me a range of different things that people have been talking in the medical field about our trial which is completely wrong. So, you know, if they had any questions, all they have to do is actually ask me rather than people making up stuff.
Janet: No, I haven't seen any research to actually say that cannabis increases tumour growth. However, in the medical fraternity, and I've heard it said a number of times now that cannabis can increase tumour growth. To my knowledge I haven't seen any studies that show that cannabis itself increases tumour growth. And not to say that it can't. You know, I think anything has a potential for doing stuff because it's...there are so many different factors. So I'm open to the fact that there is a possibility in some people that it could, but I've never seen the research to say that's the case. I would think that where this has come from is from recreational use with, like, tobacco versus looking at medicinal cannabis itself.
And I think that's where this misconception has come out and to me there's still this huge stigmatism around medicinal cannabis. And, you know, you talk to it and the first thing people go, "Oh, you know, getting high," and stuff like that, but that's not what medicinal cannabis is. Medicinal cannabis is a plant that's a drug that has specific actions and it needs to be addressed as such. And, you know, we need to lose this whole stigmatism of it being a recreational drug. You know, I've heard this one doctor, you know, put it to the same as, "Oh, it's just like ice and speed and ecstasy." It's completely different. And we need to really change the view of that, particularly in the medical fraternity. They already got a number of different drugs that they actually use that are plants and this is...there's no difference.
Andrew: So let's go into the usage of, or the actions of, medicinal cannabis. You say it's not to get high, that's got something to do at least with how it's taken. So how is this form of the drug taken?
Janet: So when we're looking at this, this is in oil-based extraction. So it's...it comes in a small bottle, as most of them do, 60 mls, and it's an oil extraction using both coconut and olive oil. And there's a whole process of it because it needs to be carboxylated to release the THC and CBD. And the one that we actually use is an organic one, it's using the whole plant extract that comes from it, and there's no additives. Because a lot of the companies will put in things to replace, like, terpenes that they're being lost in the processing. So they'll put in, like, rosemary oil and those type of things to make it up.
Janet: Ours doesn't have that, it's absolutely complete.
Andrew: So it's the naturally occurring terpenes and phenols?
Andrew: This is something that really interests me with regards to what Simon Eckermann said about, you know, we really need this entourage effect, we can't just be relying on the, I'm going to quote the word, "drug" here, the THC, as the...you know, the poster child, if you like, of cannabis, and now the CBD. We can't just rely on those for the whole action of the plant.
Janet: No, absolutely. And that's what we're looking at. You know, there's 140 different cannabidiols that have actually been found, there's your terpenes, there's your polyphenols, there's a whole range of aspects that we still need to address. It's not just CBD or THC. And that's one of the reasons, when we look at the literature, that most of the trials on the synthetic drugs don't work as well as the whole plant. And that's where that entourage effect of it all working together makes such a big difference.
Andrew: You also mentioned anti-seizure medications before, and this is one of the reasons for caution amongst neurologists when they're dealing with their patients who have epilepsy. So what's been your experience with this trial…
Andrew: …when using the product with patients who are experiencing seizures?
Janet: Most of our patients on the trial, participants in the trial, are on some form of anti-seizure medication. The main one that most of them are actually put on is Keppra, which has no interaction at all because it doesn't actually go through the liver. So it's only the ones that they need to monitor, like Phenytoin or Tegretol, which requires a blood test to make sure they've got the right level, that is more of a concern. So of all the people on our trial, we only had one on Phenytoin and we had one on Tegretol. And we actually do blood tests with them to ensure if there is any interaction with it.
So we haven't got enough numbers in our trial to say if there is or isn't, but they do use the same CYP450 enzyme pathway. So there's a potential that cannabis may increase the clearance of these drugs, therefore decreasing some of that anti-seizure activity. But what we find with glioblastoma, like I said, most of the time they're actually not on those particular anti-seizure medications so there's no interaction...possible interaction.
Janet: Yeah, definitely. So the majority of people think, you know, like I said, they're going to get high, but that's not the case. So the way that we've worked it with this trial is that we start low and we titrate up slowly. So our research nurse contacts them consistently, usually every second day, when they're starting until we get to their tolerability, which is based on side effects. So the first main side effect most people get is drowsiness, so it's one of the reasons why it's worked so well for sleep. So they may feel more drowsy after they've taken it, usually about an hour or so. And then maybe more drowsiness on waking, so they'll actually sleep in longer and take a little bit longer to get going. The second major side effect is dizziness. So if they wake up during the night and have to go to the toilet, they may feel a bit off balance and a bit dizzy. Another major side effect is dry mouth, so it can cause, like, dryness from there. We had a couple people who had some mild rashes from it, as well, but they're the majority of side effects…
Janet: …that we're actually seeing. Some people say nauseous, as well, because it is an oil. So with those people we got them just to have it with food and it decreased the nausea from the oil.
Andrew: And the prevalence of side effects, what would that be around?
Janet: That's actually quite interesting. In our trial it's actually quite low, and I think, again, because we did that individual dosing in slow titration. Some of the other researchers have actually found a much higher side effect profile. And I think, again, depending on how their dosing actually goes, that makes the difference.
Andrew: And what about route of administration, would that be affecting the side effect profile, as well?
Janet: Absolutely fantastic. We've had 100% compliance.
Andrew: Oh, gosh, okay.
Janet: Which is rare. Because we give them a diary that they actually have to fill out.
Janet: And every one of them, there's been 100% compliance.
Andrew: That's really unusual because most of the feedback I get from the oral administration of oils is not good.
Janet: Well, we had a couple people who really did not like the taste and they...we had got them to mix it with different foods to one that they actually found. And that was only a couple people. But even those, because, I think, the hope that comes with this, with what could be the outcome…
Janet: …has increased it. And the lady that I just talked about who really did not like the taste of it but continued with it actually had a 20% reduction in her tumour growth and decided, "I'm going to keep on it."
Andrew: Wouldn't that be good if that was standard?
Janet: It would be. You know, that's not the standard outcome, but in that particular lady that was the outcome and she still has had reduction in growth. She's obviously on chemotherapy, as well. She's on temozolomide as well.
Janet: But it just shows you the potential that could be there.
Andrew: …to achieve their end goals of reducing tumour growth? I mean if nothing else to reduce side effects, but potentially to enhance its actual action. This is what I like about, you know, natural medicines, about the potential to help existing therapy.
Janet: Exactly, I totally agree. You know, there's never going to be one thing, and not one thing is going to work for everybody, and I don't expect cannabis to work for everybody.
Janet: We’ve had 18 people pass away on this trial already, and that's not including the ones that we had on our waiting list to get on. So, and we've had people where they have had increased growth. You know, so I think there's nothing wrong with looking at something that can actually enhance standard treatment, which is what I think cannabis can do for glioblastoma. And not only enhance the treatment, but also enhance quality of life and possibly longevity.
Andrew: …you know, initial responses. What's your hopes for the future, where do you think this is going to lead? Obviously a multicentred trial, but is there optimism from other centres to say, "Yes, we'd like to repeat your trial"?
Janet: Yeah, well, I've had a number of people already contact me saying they'd like to be a site.
Andrew: Got you. This is awesome.
Janet: So that is a good thing. I think that in general there will always be the haters, if you want to put it that way, you know, about the new things…
Andrew: Yeah. Sure.
Janet: …but there's still optimism that's actually out there. And I think if people start to... Like one of the things I was asked, you know, "What would you like to tell the medical fraternity?" To me it’s "Open your eyes and see this as any other drug that could enhance your possible treatment." And I think once that actually occurs and they start doing that, I think we'll have a lot better opportunities. I think that down the line that they will. I potentially believe that that will actually happen. I believe with the amount of trials that are now being conducted in different areas, and with a lot of the medical fraternity, I think that there is potential for turning people around and seeing it for what could be beneficial, especially in diseases and conditions that have such a poor prognosis. Eventually I'm hoping it would also be on the PBS so that the cost is more available and the access, the patient access to this, is much easier.
Andrew: You know, we always think about major centres as the capital cities, but we know that rural patients fare worse with any cancer, let alone GBM. Is there any interest from rural centres wanting to repeat the trial?
Janet: They can't, I don't think, will be able to repeat the trial, but actually what you're probably talking about is being a site for the next one.
Andrew: Got you.
Janet: And yes, the answer to that is yes.
Janet: So, and, you know, a lot of people do actually have to travel to the capital cities and there has been definitely a lot of interest in some of the more, like, regional type centres.
Janet: Not, you know, really rural, but these regional centres. And I think that's an option down the line, I really do think that can actually happen in the next trial. What I'm also hoping is that Tasmania opens their eyes a little bit, too, to be able to help and join into what could potentially happen in Australia. Their rules are slightly different.
Andrew: Right, I see.
Janet: As a state, even though it's legalised federally.
Andrew: Yeah, which is interesting. So now onto that, about education, opening medicos' minds. We obviously need more education, and Dr Teresa Towpik was one of those people that wrote a course for GPs.
Andrew: Where's that headed now? Is there more acceptance, is there more dissemination of this education to other centres rather than just, you know, New South Wales?
Janet: Yeah, there is, there's a lot of different courses that are being conducted. It's not just Dr Teresa Towpik, who I think is fantastic, and it's great that we actually have these. Obviously there's Dr David Caldicott, as well…
Janet: …who actually has done a number of them and that go through some of the rural areas, as well. That is now starting to go into different states, which is great, and we do need more of that education. There's now some more online assistance, as well. And I think that's one of the biggest things for a lot of the GPs as well as the specialists, is they just don't feel competent in being able to prescribe it or knowing what to prescribe and then what to actually look at and know, like, how this is going to interact. And I think once that education becomes more clear, that it's a lot more easily accessible to the medical fraternity, there will also be a lot more acceptance.
Andrew: Also one of the hindrances was the original use of the Special Access Scheme. So now I understand that's been streamlined, the SAS Cat B?
Janet: Absolutely. TGA have actually done a fantastic job. They now have online access to their SAS Cat B that all you need is the doctor to be able to log in. They actually fill out all the different forms, it actually links to the state for approval, and they just can attach all their documentation for it. So it's been hugely streamlined to what it was previously, which is excellent. The TGA now actually can have an approval within 24 hours. Unfortunately we still need, in certain states, state approval, which can delay some of that up to like three weeks. But in the general process it’s been made much easier. I think what happens is, again, a lot of the medical fraternity don't realise that it's been made easier, they still think they have to go through the whole system.
Janet: I think the other big hindrance is the fact that, you know, they've got opioids and all this other stuff, they can just write a script and give it to the person and they can just go to the pharmacy. Whereas with cannabis they actually then have to take the time to go onto...online, fill out all the forms, put all that type of things in before they can get approval to write a script. Now that's completely different to being able to just write a script.
Janet: And that's a hindrance in itself.
Andrew: Yeah. But I understand that I think an oncologist in Sydney was saying that she...after a little bit of experience, she now has that down to about 15 minutes.
Janet: Oh, yeah.
Andrew: So it's not unwieldy like it used to be.
Janet: No, it's actually really quick. I mean I've been doing some of these for the trial, as well, for Charlie.
Janet: And I can easily do it within 15 minutes.
Andrew: Right. Okay, got you. So with regards to the future, you know, what's your hope? You talked about a multicentre trial, but what's your hope for the future with regards to helping people who have GBM, helping their treatment, helping their quality of life?
Janet: My hope is that we are able to conduct a phase III trial, that it actually gets recognised, that it can actually be put on the SAS Cat B as a treatment option for people...as an adjunct treatment option for people with glioblastoma, but also for the people with high-grade gliomas and brain tumours, as well. So it's not just the glioblastomas. And that it becomes standard treatment. It becomes standard treatment when you go into first-line things you're about to undergo, you've been diagnosed, you're about to undergo your radiation and chemotherapy afterwards if you're possible to have surgery, and that cannabis is actually given to them, as well. And if we can get it to a point where we know who is going to benefit more from cannabis and not, be that from some form of genetic testing or blood testing, then that would be even more streamlined. In addition to that, it needs to be on the PBS.
So my long-time goal, long-term goal, is that it will be standard treatment for people with high-grade brain tumours in conjunction with their other treatment, and on PBS.
Andrew: Okay, devil's advocate question here. And that is basically when you have, you know, carbamazepine, when you have phenytoin sodium, you have one entity. But when you have cannabis, you have the CBD, the THC, then phenols, the terpenes, you have a whole range of chemicals there. How do you know which product therefore to use? Because you got so many players on the market.
Janet: Part of that is being able to do the profiles of the ones that we've found to be of benefit. And also then doing the blood test. So not...every cannabis, including every batch, can be slightly different, which makes it more difficult to say, "Well, it has to be this particular one." But if we have a range that says, "This is the profile that actually helps people with brain tumours," it then gets patented, and then obviously people can do things that are similar, you're then going to have some more of standardisation.
Andrew: So yeah, so this opens up a whole can of worms with regards to standardisation. In this case it seems like we should be standardising for at least four components, THC, CBD, terpenes as a group, and then polyphenols as a group. Is that the way that we're moving?
Janet: Absolutely. I definitely think it is. It should not just be standardised to THC and CBD, we should actually have the standardisation of a range so that we do the analysis. And, you know, it's not going to be exact because you're never going to get an exact replica of it, but you have a range…
Janet: …that they need to be in. And it's not...I think it's more than just four.
Andrew: Right. So within a range you can get an accepted repeatable profile.
Andrew: So I guess, well, that would gel with regards to the 10% that's allowable for even drug manufacturing, yeah? Area under the curve variation, things like that.
Janet: Absolutely. So you have a 10% range of each of those that you can actually put into, if you want to call it, a product or that drug.
Janet: So this particular trial, it will...the last person will actually come through at the end of November. So from there I'm going to be doing a lot of cleaning data entry and stuff like that. And I'm hoping to have the first main report on quality of life and tolerability about by around April next year.
Andrew: So April 2020 we expect to see some sort of results. This is absolutely awesome work, Janet.
Janet: Well, thank you.
Andrew: Yeah. I can't thank you enough for taking us through. This is really important medicine.
Janet: I think so.
Andrew: Not the least of which we've got to understand that this is prescribed medicine, this is not going to be available in Australia to the repertoire of naturopaths and herbalists and clinical nutritionists. But, you know, this is very important medicine that you're doing to show that a plant-based drug is showing efficacy in helping patients through, you know, what is otherwise a devastating diagnosis.
Janet: I totally agree. And it's one of the reasons, I think, that it's really important and also showcases the fact that people in complementary medicine that have the research knowledge with certain plants can work really well with the medical fraternity to enhance patient outcomes and best practice.
Andrew: Brilliant words. Dr. Janet Schloss, thank you so much for joining us on FX Medicine today.
Janet: Oh, you're more than welcome, it's been my absolute pleasure.
Andrew: This is FX Medicine, I'm Andrew Whitfield-Cook.