Would you mind telling us a little bit about yourself and your background when it comes to entheogens?

"My name is Ben, I am a consultant child and adolescent psychologist, which means I trained in general medicine and then specialized in mental health and then went on to specialize in child and adolescent mental health. I worked in that field for about ten to fifteen years and then for the last ten years I've been working predominantly in adult addictions and human psychopharmacology research for psychedelics. My position is senior research fellow at Imperial College London Psychedelic Research Unit, since before it was set up actually, working under David Nutt. During that time, I have worked on studies with LSD and psilocybin and DMT and ketamine and MDMA. I am also a medical cannabis prescriber and in the last year I have taken up the position as chief medical officer at Awakn Life Sciences, which is a biotech company, first in Europe to provide a network of clinics for psychedelic assisted psychotherapies. We just opened our first clinic in Bristol, and we are planning on opening 15 to 20 high street clinics across the UK and Europe in the next few years. We are providing initially at this stage ketamine assisted psychedelic psychotherapy for a range of different psychiatric disorders. We are using ketamine because that is the only licensed medicine with psychedelic properties at this stage. Other drugs such as MDMA and psilocybin are only at the level of research and you can only work with those drugs under research protocols, but ketamine is a licensed medicine and can be used off license. It is not licensed as a psychedelic for psychotherapy, it is licensed as an anesthetic but it can be used off license in its racemic form for anything, and we are using it for a range of psychiatric disorders, including depression, anxiety, addictions, PTSD, and eating disorders. We are not an intravenous ketamine infusion service and 99% or so of the so called ketamine clinics around the world use little or no psychotherapy. They just infuse the drug as an antidepressant and thats it. We are using ketamine in the same way as we may use MDMA and psilocybin. I am an approved MDMA and psilocybin therapist. I have been trained with those modalities with map and compass. We are using ketamine in the same way as we may use those compounds to assist psychotherapy so that kind of makes us stand out. There are a few [clinics] in the States and elsewhere that do do this but generally most people use ketamine just as an antidepressant. The other things we are doing at Awakn is we are doing research. So we are understandably building on the safety and tolerability study with MDMA for AUD [alcohol use disorder] and we are currently submitting protocols for a randomized controlled study, placebo controlled study to explore MDMA for alcohol use disorder with the hope of getting it licensed for that psychiatric indication in the next few years. Like many other companies we are also doing some novel molecular development research, looking at analogs of MDMA and ketamine to see whether they can be developed as clinical medicines. I also work very strongly in the field of drug policy reform working with governmental and non governmental agencies to try and move that issue forward which has been a very long and arduous process."

 

Do you think psychedelic substances will ever be removed from their Schedule 1 classification, and accepted for medical use? 

"Schedule 1 means the government considers them not to be medicines. Which creates a catch-22 situation because it is very difficult to research them since they are Schedule 1. It costs a lot of money and it takes a lot of time to work with Schedule 1 compounds, which then conveniently means for the government that we can't move them out of Schedule 1  because it is difficult to do the research to demonstrate that they can be medicines. Drug development in psychedelics is no different from any other drug in the eyes of the FDA, EMA, or the MHRA and nor should it be. These agencies don't consider LSD, psilocybin, DMT , MDMA to be any different from penicillin or ibuprofen and of course they are not really any different when it comes to them as medicines. We have to jump through the same regulatory hurdles as we would for the development of any new medicine, so I don't subscribe to the kind of conspiracy theories that governments irrationally stop this research. All the governments are asking is that we jump through the same regulatory hoops as we would for every other medicine, so we have to do phase 1, phase 2, phase 3 studies. We have to collect the data, we have to demonstrate their safety and efficacy, and if we do all of that there should be no reason why they shouldn't be approved. So yes, we are doing that research, we are collecting the data, we have been doing it for a long time. MDMA is now in phase 3 of development. Psilocybin is about to enter phase 3 of development. When all of that research and data is in and it is shown to be safe and efficacious there is no reason whatsoever they shouldn't become medicines. Now, if at that stage there is an irrational blocking then we can start believing in the conspiracy theories, but I don't see that there would be any case to argue on the part of regulatory authorities and there is no reason once these medicines have been through all those stages of development that they wouldn't be approved. It is looking good after many decades of research specifically MDMA is due to be licensed in late 2022 and psilocybin a year or two after that. The difficulty with this sort of research is that most human psychopharmacology research is carried out by the pharmaceutical industry who need to reap back enormous amounts of R&D costs once they finally produce the medicine and it is patented. So there is little financial motivation in the pharmaceutical industry to do this because if you are developing a drug like SSRI's which you then take everyday for weeks, months, years, decades, the pharmaceutical industry that have put in the millions to get the drug on to the market will then reap back their R&D costs. But psychedelics are unique you only have to take them one, two, or three times and then you are better. You don't need to sit on a maintenance drug for the rest of your life. So from a marketing perspective it's a nightmare for pharmaceutical companies. Why would they spend 100 million dollars in developing this drug that you only have to take two or three times and thats it. They are not going to get their money back. So that does make psychedelics unique in terms of drug development. But from an ethical point of view it is the right thing to do. We shouldn't only be developing drugs that tie patients into lifelong treatments in order to reap back R&D costs. So the outcome of this situation is that it has been very slow and very difficult to do psychedelic research because all of the funding has come from charitable organizations, philanthropy, donations, etc. It is really expensive to do human psychopharmacology research which isn't particular to psychedelics its always been about funding and money. The question is will someone put up a 100 million dollars to put these drugs to market? It will happen."       

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