Dr. Janet Schloss, Clinical Nutritionist and Naturopath from Southern Cross University joined the GCI Content Hub in conversation.
Could you give our readers an overview of your professional background, and what led you to cannabis research?
I have been a naturopath and clinical nutritionist for over 22 years, and I am still consulting and seeing patients primarily in the area of oncology. I have a major interest in supporting patients through treatment and post to assist in mitigating side effects as much as possible, and to assist with diet and lifestyle. I completed my PhD at the School of Medicine, University of Queensland in 2016 where I conduced three trials on B vitamins, particularly vitamin B12 in the prevention of chemotherapy-induced peripheral neuropathy. After gaining my PhD, I have continued to conduct research.
Through my private practice, quite a number of patients were starting to take cannabis. This took my interest greatly and in 2015, I started conducting a review on cannabis in oncology. Although this review was never published, I did identify a key area of research in gliomas and cannabis. While presenting at a medical conference, I spoke to Dr Charlie Teo who presented after me, proposing my idea of conducting a clinical trial on cannabis and GBMs due to the research and what he has seen in his practice. My research into cannabis then exploded, and I have been researching into cannabis ever since.
As a researcher in Australia, what are the difficulties you have found in setting up cannabis-focused clinical studies/trials vs non-cannabis research? What additional requirements are there to get this type of research off the ground?
The first study I undertook was one of the most controversial: looking at cannabis with THC in it, with a controversial doctor and a very vulnerable patient cohort. The Australian cannabis regulatory system was still in its infancy, with medicinal cannabis newly legalised, and getting its head around clinical trials involving cannabis. Hence, there were many obstacles in terms of both gaining ethical approval, and gaining at that stage both State and Federal approval to conduct the study.
I have conducted studies in hospitals before, but always in the public on non-cannabis research, and cannabis in a private hospital took on a completely new level of complexity. So, in addition to the typical clinical trial requirements, certain licences were required, state and federal approval was required at a very strict level, and storage and transport of cannabis were extremely strict, so many levels were required. Pharmacies were not used to dealing with cannabis, so extra training and understanding had to be implemented: as the cannabis was sourced from overseas, getting it through both the Canadian government and Australian government became a logistical nightmare with investigational medical products (IMP) not arriving on time.
Furthermore, as it was a trial, I had to fly around Australia to deliver the IMP as we couldn’t post or send my courier because it was cannabis that we were transporting. In addition, we had people flying in from all over Australia so had to have paperwork for them to fly with cannabis. In addition, because of the THC, they were not allowed to drive (which was OK for this cohort) but added another layer of complexity.
Now, it’s much easier to conduct trials. Pharmacists are more aware and understand medicinal cannabis, the government regulation is much easier and state approval is not required. We now have companies in Australia growing and manufacturing products but still there are a lot of extra regulations to do with cannabis required for trials that non-cannabis research doesn’t have to consider.
Within the Australian cannabis research community, what type of inter-organisational collaboration is there? How would you like to see this community develop and evolve?
It’s quite interesting looking at the Australian cannabis research community. Considering that this is relatively small in comparison, there is still a lot of separation and exclusivity due to industry and university competition, egos, and not wanting to share or collaborate due to conflict of interests. Saying that, there are some independent groups that do bring research from all aspects together which works very well.
Ideally, we would all be working together and in some circumstances, like ‘United in Compassion’, this does occur. Although I think that, like all industries, it’s highly unlikely that everyone in the cannabis research space will work together and collaborate and that is OK, as long as everyone is respectful and supportive of each other and we all work to help advance research in this space.
Cannabis and cancer care is a hot topic. Increasingly, patients have been utilising cannabinoid therapeutics to manage symptoms, moreover, researchers like yourself have uncovered some particularly promising data regarding the ability of certain cannabinoids to tackle forms of cancer. In this, could you tell us about your research into Glioblastoma? How did the study take shape and what indications were you able to infer from the data results?
Yes, you are so right, cannabis and cancer is a hot topic as well as controversial. I didn’t realise how much until I was in it. Like you said, most of the research in this area is based on symptom management; however, in vitro, preclinical and anecdotal evidence are directing cannabis as a potential anti-cancer agent. Our study was one of the first human trials looking at cannabis as a potential anti-cancer agent, although our primary outcome was tolerance and efficacy second. Our study examined 2 different ratios of cannabis: 1:1 and 4:1 ratio for people with stage 4 glioblastoma or recurrent high-grade gliomas.
Each participant was involved for 3 months with MRI’s before- and post-intervention. After the 3 months, they had the ability to continue on cannabis and be followed for 2 years post-study. What we found is that over that three months, we had 48% with stable or reduced growth which is amazing. This cohort have a 6-18-month survival rate generally as GBM’s are the most aggressive brain tumour. Two years now post-study, we have found that 50% of the participants are still alive, which is extremely unusual for this patient group.
So, what we infer and what was identified was that for patients who were quite advanced, cannabis didn’t not help reduce the growth but did help with their quality of life. Cannabis was found to be potentially protective and assisted the efficacy of those on chemotherapy. I believe that cannabis may assist survival in this cohort for some people, but we still need to know more as to why certain individuals react better compared to others. But there is so much potential.
For a study such as this, what should the next phase of research look like?
Ideally, this study would lead to the next phase which would be a trial on newly diagnosed GBM patients who would continue to take cannabis until disease progression or death. Further testing could be conducted on genetics, individual markers, type of tumours, metabolism of cannabis snips or similar biomarkers to identify which patients would be more susceptible to the benefits of cannabis compared to others. Biopsies of the tumour could be tested to see if cannabis would be of benefit to that patient. The issue, however, is that GW Pharmaceuticals have a patent on cannabis for GBM so now most companies do not want to spend money on trials to ascertain if it is of benefit or not.
I have been applying for different grants, but grant money for research is very limited and competitive. This doesn’t mean that it’s not possible, but it does make it much harder to be able to perform the much-needed research in this area.
What other conditions are you researching/interested in researching, pertaining to cannabis as a therapeutic, and why?
Currently, I have a number of research project streams underway. I have a PhD student who has taken up my fibromyalgia and cannabis research which is very exciting. I also have a Master’s student undertaking cannabis and autism. I am currently conducting trials on CBD for sleep disturbance, undertaking surveys for cancer-related pain and cannabis, conducting pharmacokinetic studies and looking at endocannabinoids in fibromyalgia and post-natal depression. I am still trying to get grant money to conduct further trials, so I have my fingers crossed.
The reason for doing this is for people suffering or dealing with these conditions. I have seen so many people with fibromyalgia who have found benefit with cannabis but the research is not strong enough yet for clinicians, particularly rheumatologists, to be suggesting it. Similarly for autism, I have numerous children and adults who have found benefits with CBD for some of their symptoms but further trials are needed, particularly looking at delivery systems in this group that are easy to administer and go to the brain.
I also have a huge interest in the endocannabinoid and pharmacokinetics of cannabis and I think we need a lot of research in this area to really understand the inter-relationship. And lastly, I will always have an interest in cannabis in oncology. There is still a huge stigma and block for cannabis use in this space but, if we can get past this and are able to conduct robust trials, this could be turned around. The main thing that underpins all of the research is the benefit to the people who are experiencing the disease and condition. I always believe in patient-centred and lead care.
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