The Special Access Program (SAP): What We Know So Far - A Prescriber Discussion

Transcript

so i think we can get started it's two minutes after uh i'll just start off with some indigenous acknowledgement uh the group at theracell just started reading the book braiding sweetgrass and the first chapter is the origin story of sky woman creating turtle island uh and i've just been reflecting lately on on the power of that origin story and how different it is than other origin stories um and the power of perspective and and and narrative within our lives and i i'm really been reflecting the last couple days about the beginning of reciprocity i think for for myself is understanding that i see my life and my experiences through a specific western lens because i haven't had this knowledge or these stories in my awareness and you can only see reality based on what you know so i'm just motivated to learn more and to gain more knowledge about indigenous practices and indigenous cultures i'm in victoria which is the unseated traditional territories of the luangan peoples represented by the song he's esquimalt and wasteenich and we advocate for psilocybin in the western medical context but uh what psilocybin and the knowledge of psychedelic medicines and ceremony wouldn't exist without the indigenous knowledge keepers my name is natasha fernley i if you don't know me i am theresa's clinical intake director i'm also a registered nurse i've been working with therasil for a couple years now since the beginning helping people get access to psilocybin helping to build their processes out and i'm really excited to head this sap in service today i think there's going to be a lot of important information shared as we move forward i'll let valerie masuda who's here with me today who has a lot of experience and knowledge to share introduce herself before i get into some um some background about the the in-service to kind of um support what we're going to talk about but val could you let everybody know who you are what you do whatever you'd like to share with the group i'm valerie masuda i'm a palliative care physician over on vancouver island i've supported a number of patients through the section 56 exemption process uh over the last year and a half um and uh have had the opportunity to be in there psilocybin sits with a therapist as well as we have developed a non-profit organization called um uh my community journeys which uh has two programs one is the ketamine assisted therapy program um through roots to thrive and the other one is the soul fiben assisted group therapy program we started in october we've brought through nine patients uh successfully through our first cohort and are now bringing in hopefully eight patients for our second cohort and through the sap process so i'm hoping to share some learnings with my conversations with health canada how we proceed through the quagmire of the bureaucracy thanks val before we get into the nitty-gritty about sap and what we've learned so far i would love to just prompt anyone who's here to share in the chat if they've navigated sap somehow and let us know what your experience has been like if you haven't navigated sap yet but you're considering let us know why why haven't you navigated yet what's stopping you what are your concerns and if you have any specific questions that you're hoping me or val or someone else on this call might be able to answer we can discuss we'll try to get to those and holly who's supporting us is going to be popping them into my document here so we can get to them at the end for a question period just setting the stage a little bit for this discussion uh therasil has supported 58 canadians so far to successfully successfully receive section 56 exemptions you probably are aware but section 56 exemptions allow the patient themselves to legally use and possess and transport a certain amount of psilocybin for their medical use so it essentially decriminalizes a small amount of psilocybin so they can use it for medical purposes mostly psychedelic assisted psychotherapy but they need to um gain that psilocybin from unregulated sources so the black or gray market and on january 5th of this year health canada announced uh amendments to the special access program which you likely are all aware of that's why you're here uh but these amendments now allow prescribers uh to submit requests on behalf of their patients uh these patients have to have a serious or life-threatening illness and they can request a safe supply of psilocybin synthetic or synthesized that is manufactured or imported by a health canada approved licensed dealer and what we've seen at theraceo when with the patients we've supported is that any patients who submitted a section 56 request before or sorry after the sap amendments uh they received communication from health canada that their section 56s wouldn't be considered that they weren't being um approved and that they would have to prove that they've gained access or tried to gain access through illegal means which is clinical trials or sap we've tried to advocate for these individuals who don't have a way to get access to sap currently through their physicians communicating to health canada them communicating to health canada why section 56 is still the best route and we continue to get the same communication from health canada go to clinical trials or go to sap currently theracell has over a thousand patients uh on our wait list many of those are looking for assistance when it comes to mental health specific uh diagnosis some for chronic pain and i also have over 50 individuals who are currently trying to gain access who have palliative or life-threatening diagnoses and so just navigating how we can support them moving forward with these changes my goals at thericil when it comes to supporting patients moving forward with these changes is i really want to obviously help as many people as we can and so i want to build out a process that empowers prescribers across canada to support patients with psilocybin access so i want prescribers to be able to become comfortable facilitating assessments of patient suitability for psilocybin therapy to feel comfortable supporting patients and navigating the legal pathways and also to understand what they need to do and how to provide medical oversight for these psilocybin treatments and so the ways that i'm hoping to move forward to empower practitioners like yourselves and others is first of all building out our website so that there's really clear steps and guidelines for patients and their healthcare practitioners for all of those things assessments legal pathways how to provide medical oversight and how to support us and i'm going to have many updates on the therasils patients page as well as the support your patients page so if you're interested keep an eye out we'll also announce in our newsletters about those changes we're also going to be creating prescriber-specific education and in-services to build out the knowledge and understanding of prescribers for the ways that we would like them to be able to support patients and we also hope to be able to build out a system for community prescribers to request consultation with psilocybin informed physicians or to also request referrals to physicians who are able to take on the responsibility of supporting a patient as providing medical oversight if community prescribers don't feel comfortable doing so um so in order for me to be able to launch this process and be able to have a system for the patients we support to be connected to people who can support them and organizations that can support them first i really need to build out a pool of prescribers that i know can support patients and are able to take on those referrals and so the starting point of this is just kind of building an understanding of who in canada and who's associated with aerosol who's interested in working with therasil to do some further education as a prescriber or support patients who are reaching out to us and so i've created a little google survey that i would love anyone here to complete it's really easy you get to see kind of what we're thinking about for prescriber education within there uh as well as let us know what you might be interested in moving forward it's just a might you're not signing up for anything for doing a survey holly is going to share the survey in the chat and we'll also share it in the email that you'll get after this with the recording of this webinar so yeah please take part in that it will really help me moving forward with our processes so circling back to the main goal of this webinar we want to empower prescribers we want to support as many patients as we can and we realize that right now there's still many under unanswered questions about the current legal pathways including sap access uh and so i'm going to hand it over to dr valerie masuda for her to now share her experiences with sap what she's learned so far and anything else that she thinks could be informative for us as a group thanks val right unmute um so i just wanted to first say that we've had a lot of discussions with health canada and they're two separate um pieces of health canada departments one is the exemptions office and one is the special access program and it was interesting when we first started having conversation with the special access program they admitted that we actually don't talk to the exemptions department very much and so we managed to actually get a meeting with myself um a representative from therisil representative for maps and a representative from the canadian psychedelic association we met with health canada with the exemptions office and the sap office in the same room which was super informative so what i'd like to do is start with what is health canada's reasoning behind changing from the exemption process to the sap so basically exemption is basically decriminalizing philosophical for one person so that they can access store ingest a substance which is uh controlled and i think health canada was okay with producing it with providing a few section 56 exemptions for this but then when they get you know the swamp as as the canadian public says hey you know this works for so many things people do their research they see what's out there on social media and the regular media and they say we want access so health canada gets now hundreds and hundreds of requests for section 56 exemptions now health canada's mandate is to protect the canadian public they they look at regulating um food and drugs uh and this is being a drug but an odd drug because it's being consumed as a botanical it's not a food but it's a botanical and they said you know we cannot as a as a government service health service be condoning the use of canadians accessing um condoning the use of canadians accessing a product we have no way of monitoring or scheduling or anything like we have no control over mushrooms um and we don't want to be seen as supporting this process you know even if it's on a compassionate basis so how can we do this give canadians access for evidently the canadian public is saying we want access but do it in a safe way where we know that canadians will be accessing safe and secured product so they refer to the the sap program the special access program so they basically say no to exemptions we do not want to be involved anymore in decriminalizing this medicaid this this substance for people to be consuming for whatever reason so that door is essentially shut so now we go to the special access program and they say you know what the program is designed to do is if for example um somebody has a very rare cancer and or they have they've tried all known um treatments available in canada and the oncologist notices that there is a study in the uk using a product that is approved in the uk or the states that is not available in canada they actually can apply for special access to this particular product to administer to their patient and what they have to do is their due diligence they read all the literature associated with it they ask the manufacturer for their human data so that those manufacturers actually produce a product that is involved has been involved in stage one clinical trials and is on the way to finishing stage two clinical trials so health canada is pretty sure that these substances are safe for human consumption so once a physician establishes a producer a producer that's willing actually to provide the drug and health and and the sap program um he was basically saying you know we we have a drug in the states we know is going to help this little kid with this very rare condition but the manufacturer will not produce it in a dosage form that is suitable for this pediatric patient so we can't there's nothing to approve so so the oncologists say in this case the physician has established a producer has reviewed the stage 1 and stage 2 clinical phase 1 phase 2 clinical trials has received the human safety data from that producer and is pretty confident that this is a safe medication for his patients or his or her patients can then apply to the special access program and say this is my patient these are the treatments tried and failed this is the treatment i want to try this is the human safety data for it and can i try this and and i'm willing to procure the drug i'm willing to administer the drug and take responsibility for the administration this drug and i will report back to health canada as to the effectiveness of this drug any adverse effects so this is what the special access program is about so you know they say this was never meant for psilocybin but health canada has actually been going back to the producers and trying to figure out how they're going to navigate this with psilocybin now the exemptions office went out and asked all the producers the psilocybin the people who have a section 56.1 exemption to allow them to produce psilocybin either by growing mushrooms or producing synthetic and they approached them and said hey does everybody here want to be on a list of you know potential suppliers and everybody said oh yeah we want to be on that list so they have this huge list of potential suppliers but only two of the people or to the people two of the companies on that list actually have product that has undergone phase one clinical trial and only two of those names on that list are able to provide to the special access program so it took uh the health canada special access program actually went to all these people and called them and established whether or not they were will they were able to supply we had first gone to usona which is the supplier in the states that is supplying just about all the clinical trials in the states and they said no our mandate is to actually supply clinical trials we have been approached by many groups about supplying programs it's outside of our mandate we will revisit this because canadian special access program went to them directly and asked about this they said it would take many months for us to sort that out so the special access program then came back to me and said there are two companies you can approach that we have have product that we would consider safe for human consumption so having said that i have to then contact the companies and say i want this amount of psilocybin are you able to provide that to me so the answer is yeah but are you but are you able to to to treat the patients with their product because um the producers don't want to just you know give away their product willy-nilly to especially physicians who don't have any experience in treating people in the psychedelic space they don't need the bad press if something goes wrong and they don't need that bad press reflected on their product so they're very cautious so for me um we have a non-profit society it costs us 22 000 to get insurance to be able to administer psilocybin in our space just a liability insurance alone because we're using a controlled step since it was extremely expensive and so we managed to get donations to cover that cost but you know we had to show our liability insurance to the producers to show them that yes there was a team of experienced uh therapists and physicians and nurses that would be deliver would be administering the medication within a um a program that they felt very confident about and safe about so once we received the okay then i had to get their their safety data which is you know i had to sign confidentiality agreements that i would not share at one company's data with another one or anybody outside of myself and our team and i had to review that and then i can actually say to health canada i reviewed the human safety data this company is willing to supply me with this much um psilocybin and we're ready to go on this date so that's what i've had to do to negotiate the sap process so you know we look at how do we go like if i had a single patient how would i support that patient i'd have to fill out the form i'd have to find a producer which you know and it would be really developing a relationship with one of those producers because you'd only have to do this once right and if other producers come on board they may come to you and say hey we'll offer you product too you know but i've had a lot of producers come to me and say hey we'll offer product too and i'm like but health canada is not sap programs never going to approve your product you haven't tested on humans yet so uh so there's a lot of navigating that so once you've developed a relationship with the producer they're willing to give you um product in the dosage form and the amount that you need then you have to you know uh use that in your application you have the producer you know that they're willing to provide for that specific amount um having said that uh even the the producers that we that are health canada potentially approved because they have high clinical trial data um they don't they don't always have product available on hand um so that's another consideration so i did anybody have questions at this point i would like to jump in here val and just ask if you could touch based on the status of your current sap requests have they been approved are you still waiting for verification from producers we have we've gone through all the steps i've resubmitted our application with the verification from the producers and the commitment to provide the exact milligram of product that we need in the form that we could use because we're treating eight patients simultaneously we're able to access enough product to be able to treat them simultaneously at a certain on a certain date so um so i am still waiting at this point but we've gone through all the the process of um of the rest of the process of application so we do have a producer who is willing to to supply us that amount i was i i do have a sample sap form that we could go through just to show you um i think most importantly how you would how you would represent a patient and and also the we have a list of the um references that you would need to attach to your sap to demonstrate that you have in fact done your research and i would encourage you all to read the references and pull the reference material any other questions i see ryan's uh hi there yeah my name is ryan mater i'm a physician family physician in victoria um uh valia thanks so much for the talk and i was just wondering can you share with us who the the providers are the industry providers are good question uh the one is cygen cygen has a synthetic product and the other is filament and filament actually has a natural extract and they have are currently supplying phase two clinical trials in canada and you know health canada said hey if they're they're supplying clinical trials that's good enough for us if they're phased to clinical trials so they have sent me their again their their safety data but i am not allowed to share that but they do have an extract from a natural product a filament okay thanks and and does one seem one um company seem to be more accessible than the other for the through this process i think they're both pretty keen they're both pretty keen to um demonstrate that their product is safe and they're keen to demonstrate that they they can provide the product through the sap program because it's good for them but um that's saying uh you just you have to develop a relationship with these people i know that um filament has uh they're able i think to supply in small amounts at this point but uh cygin cannot at this point produce um like small amounts like 25 milligram capsules they have very limited supply of that but um what filament does is that they um their extraction pro they extract the psilocybin from the mushroom and then they freeze dry the extract and then they encapsulate it and so they have product they say they have product on hand and 25 milligram capsules so 25 milligrams of psilocybin is what generally has been the dose that was studied and when you look at the studies they've looked to say is there a dose response relationship and there doesn't seem to be a very clear dose response relationship there's kind of low dose and high dose and the in the studies they generally just gave everybody 25 milligrams and um and then went with that they didn't uh they had one usono was providing 25 milligram capsules everybody got a capsule there's no uh milligram per kilogram dosing great thanks for explaining hey i'm going to share my screen just to share the sap um can you ask a question as well please yeah so the list um provided and helped canada of um producers that they have approved oops you know they've given a a license to cultivate and grow you're saying that that even even though health canada has approved them they may not allow you to access their product through the sap so you still have to provide so so if health canada says yes to these two producers they you can access and you can access the product and they said they will provide for you you still have to give evidence enough evidence that your patient requires the use of psilocybin and under what conditions you're going to be giving it to them does that make sense if they could still deny you they could say you know it doesn't look like you've tried everything so this is where in the application there's i think there's good evidence to show that people particularly with end of life existential distress there are no current effective treatments so they don't have to be on several antidepressants anxiolytics in order to apply but i think it's important to incorporate that in your sap request and so i'll show you the references for that and maybe natasha if i send you that can you see the right thing does it say sap am i sharing the right town yes okay yeah we can see it what's the right screen i can't take the screen so val are you saying that through the sap you cannot access um psilocybin as a raw product but they want you to access it as you know pre-made capsules and and either or synthetic so basically they will only approve a drug now extracts there's sort of a gray area for extracts so if the extract says they can prove a milligram per ml amount um then they would consider that because for example sativex is an extract so you know there there are um other medications that that are extract based but it has to be able to have a din number associated with it at some point so they won't at this point um say yeah you can have just like like raw silica it's hard like having a psilocybin powder you know if you're trying to you know trying to put 25 milligrams in a capsule which they have done in certain studies like cygen has provided to the uk and they've just sent you know packages of raw psilocybin and somebody there has compounded it by hand but that's that's not something that sap is really into right they want you to be dispensed exactly what you need from the producer so you don't have any floating around um so for us if we're asking for eight patients we're asking for a vial of 200 milligrams which they can provide and then we're going to reconstitute it and because we're treating everybody immediately we'll reconstitute it with you know 200 ml of these 55 or sterile water will dissolve it and then everybody gets their 25 milligrams from that so for us it would be easier but to do one off with 25 milligrams it'd be too hard to um get 25 milligrams of powder well they may be able to put 25 milligrams of powder in a vial and then you can reconstitute it but they're not kind of at that point yet so i can go just through the the special access program form so you know this is all easy peasy stuff um the key is sending the drug so currently we do not have um pharmacies that can accept um this medication and particularly since the physician is the one administering the medication it's important to either uh for it to go to the practitioner's office hospitals um will not accept psilocybin at this point or health authorities they don't want to be involved with the liability of that um if you are accepting the phil fibin you have to demonstrate to health canada that you have a facility which is locked so if you have an office and you have a locked door and a safe then and the safe is integrated like the safe is screwed into a wall or floor or something then you can store that product uh and safely so um [Music] then we'll go into the manufacturer you have to put the manufacturer in uh and just po order i think it's kind of dumb it's just your invoice for a number um and then for us it's always oral uh ingestion and for us it can be either a capsule or it can be a powder that's reconstituted um if you in fact for us for example we have eight patients uh if one died or dropped off the program and we are able to bring somebody in another person in to replace that person then we could actually request that that that supply for the one patient is transferred to another patient um now the patient information is very interesting because yes you can put multiple patients on one form uh the patients are actually de-identified and they're only given by first and last initial and the date of birth so in fact sap isn't really interested in the whole the patient as a person but just wants to be sure that they are approving an appropriate use for this medication um we have eight people so we're you know the amount of drug that we're requesting is like 200 milligrams but in this case i just put like two patients here um and how much you you uh you're asking for and then they want to know when you're administering or dispensing the drug to the patient um and then they want the clinical rationale about emergency for which the new drug is required and this is where i've just put some samples of how we've approached this so you have your patient who they are what they're suffering from why why they need what what the indication is for the psilocybin and this has been very important is that as described in reference this form of distress is resistant to conventional treatments and there's a reference for this and this is a reference to a cochrane um uh study mitchell 2011 which actually indicates they did a big med analysis of antidepressant treatment in cancer patients suffering from depression and anxiety and showed that there really wasn't any significant benefit to any using this big meta-analysis so i think it's very important to include that particular reference um so for me i had a number of patients who i had like three patients in this cohort were young women you know they have young families and they don't want to take a sedative um i have another patient who who it's against your core values to take um antidepressant or a sedative um and you know i think bringing those also those issues about who your patient is and why they don't necessarily want to try an antidepressant because not only are they ineffective but they don't want to actually use those medications doesn't mean you have to trial your patient through many many different medications and certainly for our end-of-life patients we don't have time to trial them through multiple antidepressants so um so this was just sort of an example of how i presented the patients uh and again not having a list some some patients do have a list of antidepressants and things they've tried with the exemptions process i've had patients denied who have tried really everything um and yet some bureaucrats stamped no not approved and i you know i've had patients die with uh with their section 56's um in denied with extreme existential distress so um i think that this if if we manage to find a formula that works with the sap program the government's like okay we're providing access to canadians and we're doing it safely then this will be maybe not a bad way to go so at the end of all this you know you sign your attestation document yeah everything's correct and then we have i have a list of um references uh about the youth the psilocybin the effectiveness um the uh and um under the conditions at which you would want to uh administer the psilocybin so this isn't a physician walking into a patient's home giving them a drug and walking away i what i see is physician therapist teams who are very skilled in doing the pre-work and in all the the literature we have you know you have your three 90-minute sessions with the patient for preparation intention setting you have your one sulfin treatment uh usually with a dyad either could be a physician and patient a therapist or two therapist where the physician comes in administers the medication sits for a bit leaves in his own call but also if they're coming back to look at the effectiveness while the volvo therapists send you the sit as well as the uh three treatment and integration um visits after that so um [Music] so we're happy to share our our lists of um of references with you so you can have something to read too uh but i think it also looks towards some and some of the the references uh are not particularly relevant to the um specific sap application but it just does demonstrate some knowledge within the within the use of the psychedelic space for these patients well i would love to jump into some questions now just having a look at the time uh and before we do that i i'll just throw out there that um you all of you probably know that thera still has a training curriculum and we have a lot of therapy teams and practitioners going through who can potentially support physicians within the context of these sap requests and so if you're a physician or a practitioner who's looking to support sap requests therocyl is working on establishing a system to be able to connect these trading practitioners who are trained with the uh prescribers so that they can we can build these teams out and so reach out to us if you're looking to make those connections um something that's coming up for me val is just the thought around when i connected with health canada at one point i was communicated that section 56 exemptions may still be considered um if that it can be proved that clinical trials and sap isn't a reasonable route and i'm just wanting to throw it at you the thought around do you think that as we navigate sdp moving forward and as we learn more about who gets access and how it is accessible we'll have more um rationale to be able to share to the section 56 office about how the section 56 is still should be granted and we may move back to that process i don't think we'll ever move back to it honestly because health candidate is again they do not want to be in a position where they are seen to be condoning the use of an unregulated and unsafe product and a story and i think that's why they shut it down and provided another portal for access so quite honestly every time i discuss this with health canada it's the same message find a clinical trial do sap we don't want to talk about it anymore you know it sounds like it sounds like they can't say 100 the section 56 is a no because of the whole compassionate perspective but they're just going to keep directing us away and i'm i'm thinking that maybe then what's going to happen is if we prove that sap isn't accessible and if we see the ways in which it isn't getting people access maybe then we're moving forward towards regulations i see you know quite on i don't see it happening because quite honestly if you look at at which is better having um these producers jude like cannabis like sit on the you know everybody and anybody can access it any doctor can prescribe it people can just i mean people are microdosing but this isn't microdosing this is taking a psychedelic dosing um and you know how vulnerable people are emotionally vulnerable psychologically vulnerable physically vulnerable in that space they do not want to be putting canadians at risk and uh it is what i think they want and they want it they understand that these medications are very powerful that they can be used effectively for depression anxiety um probably substance use disorder and they want to make sure that they do this right so that we're not they want to make sure we're doing this correctly so we're not going to shut it down like in the 1970s where it just like poof no this is not going to happen so if we do it right if this is where health canada is thinking if we do this right we can possibly have programs developing um with you know with using these psychedelic medications in a really helpful way but what they've done is they put the cart in front of the horse right they are saying yeah you can do saps but there's no physicians to prescribe it there's no there's no multidisciplinary teams that can support you know groups of people to have access to treat actual treatment right so um this is where i think there's going to be a bit of a stop uh unfortunately you know even though i'm very you know i've been working very hard to get my group through as soon as my group's true they're going to say hey other people are doing it so figure a way out so this is where where i see therasil as being able to support patients by getting together these therapy teams across the country where you have a prescriber linked with some therapists where you can prove to help canada we are going to do this right even outside of a clinical trial because let's face it there will be clinical trials but we it's not like big pharma who has billions of dollars that can pour into a clinical trial these are grassroots organizations who have no money and so we are having to rely on you know clinical trials out of the universities and and cihr has just announced that they're going to dedicate 3.5 million dollars towards um psychedelic therapy for i think it was substance use disorder um specifically uh but you know these are going to be years and years um coming down the pipe we're not looking at what are we going to do now so now what we have to do is train people get physicians up and running supported by therapists so we can start delivering this medication out in the community safely and effectively amen i'm just going to jump to another question here that maybe i can answer it says i am keen to do the therausal training and wonder if it's worth waiting for the prescriber training or applying to the current training that's available and so just to speak to that the current training that's available is an intensive usually week-long in-person uh training that's supposed to prepare you to be able to provide the psilocybin assisted therapy in a cohort or in a dyad and so you're trained to be able to hold space to understand how to be there for someone and do experiential if we gain access to be able to do that and so the prescriber training that we're creating is almost like um supplemental education to anyone who's either done that training so that they understand specifically things focused for prescribers like inclusion and exclusion and patient safety and medication discontinuation um and so if you're a prescriber who's providing medical oversight you don't necessarily need to be there on the treatment day or be the core treatment team you may have therapists that are doing that that have completed seriously training and you may be providing medical oversight which would you'd get all that information from our subsequent educations that we're going to be launching so if you want to gain a week-long education about how to actually do the solution assisted therapy and feel confident to do that yeah sign up for our training get into that that's amazing we love to have prescribers who can do that but if you don't have the time or it's too much of a commitment and you still want to support patients these extra modules will supplement it and will be another building block to be able to help physicians do what they need to do um so someone's asking uh i would love to know more about what sap might look like for patients who are in the hospital oh well it would be a no-brainer no go because the hospitals will not allow you to go in with a controlled substance and treat the patient it would be a no go to we we found when we were uh so our program was running through viu and um our health authority but as soon as the health authority when we tried to bring the still five and arm because we were using ketamine uh for uh psychedelic consistent treatment and um anxiety depression as soon as we said end-of-life patients biu dumped us and as soon as we said psilocybin our health authority dumped us it was just like oh no we're not doing that um just a comment on experiential training um i know that um this is my personal view is that everybody who does psychedelic medicine should have experiential training in the psychedelic space um and currently there's no legal way um to access this you can access ketamine assisted psychedelic therapy if your primary care physician writes a little referral saying hey man this this guy is really suffering from whatever and they should be referred to a program which is an underhanded way of accessing it but the only way that health canada is going to let health care providers and they've said this many many times access experiential training is through a clinical trial and i think we could as the community develop in conjunction with the university or several universities a clinical trial looking at uh administration of psychedelics to healthy volunteers to see whether or not that are training and provision of psychedelic therapy there are a lot of producers out there as you saw on the big list that health canada has released and they don't have any human safety data and they will not get any of the safety data unless they do a phase one clinical trial so i see big opportunity and connecting with these these uh companies and saying look we have healthy volunteers here who want experiential training why don't why do we all get together and do a phase one clinical trial with these products right so you know incorporating universities uh producers because we don't have big pharma on our side right um i think this is the only way we're gonna get experiential learning into the system is to do it through a clinical trial because health canada is just not going to say yeah you guys can go and have a good trip and whoever wants to say hey i want to have some training can have a good trip too they're just you know that's of course i'm being cynical about it but and that's where they're coming from right like there's no medical indication for taking a medicine you shouldn't take it and so training is not a medical uh reason i'm sorry another question sorry i just had a good question because you mentioned that you were transitioning or you were adding on to a ketamine program and i'm just i know it's not the point of the talk but i i'm registered for ketamine training coming up and i'm just wondering uh like just a 10 second overview of why you would move to psilocybin above above ketamine or how ketones being effective for your patients yeah so um you know i've been uh through ketamine training program as well and this is where i'm spring joining off into the phil fiber realm ketamine you know the time at which the brain actually has the potential be plastic right you're talking about a 90-minute session with im ketamine for example um and it doesn't appear that the that the effect is very durable you know people are often having to be uh redosed and you know in some clinics people are being dosed every week kind of thing with psilocybin uh when we look at the data uh from from randomized clinical trials one dose has a 14 month effect and it's probably because people go really deep so you know i've had experiential training in both ketamine is like this and psilocybin's like this right you go super deep and for super long so you know you're looking at a a four hour four to six hour um period of being uh in the medicine versus academy which is sort of in and out so um you know the the data there are ketamine trials with people with existential distress and ketamine's legal and it's easy to access so there is a potential for developing these models in the ketamine space but psilocybin just seems to be just that much more effective as far as one treatment and long durability of response thank you very much all right can i ask a question about um sap again specifically um so you had mentioned um going to saigen and filament and getting their safety data um was that a requirement in order to apply for sap and did you include that data along with the application was it required uh yes i i i had to review it health canada had specifically asked if i had reviewed the human safety data with this and says it's your your responsibility as a clinician to ensure that these drugs is safe um and because it hasn't been through phase three clinical trials once something's through phase three clinical trials you can prescribe at you know with gay abandon but but um because of these have only kind of gone through the phase one clinical trials and have not completed even phase two clinical trials then they're like you need to do your due diligence right and you have to show us you've done that so uh yes um they have such a scigen and filament safety data already but they want to make sure that you've also reviewed that and so their liability is transfer liability transfers to you and the responsibility transfers to you as a clinician this is a great lead up val to a couple more questions here so where in the process does the physician like call up scigen sorry and filament and say like can i access yeah when you have a patient yeah when you have a patient and you have a plan about how you're going to treat the patient that you have a plan about okay i can acquire it i have a place to store it and i have a plan and how to administer it even in the all the clinical trials right even though there was a therapist dyad that was sitting with the patient a physician was required to take the psilocybin out of the safe bring it to the patient and witness ingestion before they left the room so even in the clinical trial that was my question um i meant more like in the context of when you're filling out the sap well i'm not a physician so let's say when a physician is filling out the sap form do they fill up the sap form first and basically name scigen or uh the other company do they put that in the manufacturer's thing submit the form then call them up do they call them up first before they're even filling out the form filament sorry uh where in that process are they actually calling up side gender filament and saying hey i'm filling out a sap i need to get some psilocybin from you guys before before they actually fill the the sap they should contact the producer and say one do you have product on hand that you could provide for my patient i have one patient do you have 25 milligrams um of psilocybin available that's the first thing because you may put in this the whole sap application with cygen and then they say oh we we didn't know you were doing this we don't have product for you and then you go i have to reapply with somebody else so you put in be at this day of age you know early days yes you have to contact the company directly and and and um get a guarantee that they would supply you are going to have to provide that company information about your treatment plan correct so that they feel comfortable so you want to have that created before you reach out yeah you want to say you know um you know i'm not just joe blow physician that i've gone through some training that you know i've done this before um that i have support with whoever therapist and this is what my plan for administration because again they're very they're kind of like like for me i had to show them my insurance policies right like it's not that easy but and they're they're kind of navigating this as well so we're the first people outside of a clinical trial that they are going to be providing for so you know i said really it's going to be really important for you guys to get up and running as to what is your policy about you know providing one-offs to physicians like one 25 milligram capsule to a physician who wants to treat one patient and so they are still navigating that space too and someone uh mentioned aren't the manufacturers released from any liability with the outcome of the sap as it's solely the responsibility of the prescriber yes but maybe not and one thing they don't want is bad press like they may be free from liability in the courts but they're not free from the liability of bad press if somebody goes public so that's what they're really fearful of because it's a very secret they're very secretive about their product and it's very very highly competitive right now um so and and you know you look at pharmaceutical companies you know they have gone through phase three clinical trials and they produce a product and yet there may be a class action lawsuit about some some side effect or adverse effect that comes out years later so they're not completely uh a free from liability so i think they're this is a new space so they're they're really tiptoeing that carefully when you spoke to health canada val um did they explain why they would approve so many people to be able to cultivate or grow psilocybin for instance and then like who are these people like what do they approve them for now that they can't actually sell the product anywhere legally they approve them for research they approve them for growing and supplying clinical trials if you look at what they've actually the section 56.1 is for it's not about providing to the public it's about providing for clinical trials um and that's kind of where it goes and they will also now say you can you can apply you can now provide through the sap so the one part of healthcare is saying you have a section 56.1 you can provide clinical trials in sap but sap is saying whoa we're not going to we're not going to approve you know companies that have not finished the phase 1 and phase 2 clinical trials right so that's the two don't talk to each other thing ryan i see you have your hand up as well hi thanks yeah um you'd mentioned value mentioned uh 22 000 in insurance liability insurance that's obviously cost prohibitive for the vast majority of providers out there and i'm just wondering what kind of legal guidance um you received in regards to that and you know with within the realm of medicine what uh the cmpa has directed you if anything so that's a good question um we were kind of looking around for insurance because uh we were we were kind of kicked out of viu and we went to we kind of explored what do we need for insurance like for general liability insurance and everybody out there was like you're doing a controlled substance that's actually legal through section 56 exemptions we're not going to get involved so we ended up going through lloyds of london who actually insures the clinical trials and this was the first time they actually insured a program we had to do they were originally going to charge us 35 000 and we managed to talk them down to 22. um and we i talked to we talked to cnpa and cmp and the college are pretty hairy fairy about it they go cnps well we'll protect you for anything that's within your scope of practice but you should check with the college they're the ones that determine whether you're practicing within your scope of practice and then when i go to the college they go well it's kind of like alternative medicine so you just have to conform to the alternative medicine guidelines i said well this is now legal right like and they're saying well you know we're not going to bring out any policy until it's mainstream so so we in addition to the cmpa uh liability insurance which is like two million dollars we have a top up to five million dollars through our general life our new liability coverage which also covers all the therapists and the the nurses and people who are not medical professionals that are working within the team as well as the venue so it would be up to your individual office insur yeah it would be it's about the venue right like if you're giving the psilocybin in a patient's home the patients the patient holds the liability insurance i think because it's a patient's home but if you bring the patient into your clinic it's a totally different situation and you'd have to ask your the the insurance agent who holds the insurance policy with your clinic to determine whether or not that would be okay with psilocybin academy is no problem at least in bc because the college says you can give ketamine like anywhere i'm sorry about have you actually done the home like administering and or do you know people who have done that yes i have done home um uh for a number of patients of mine with a section 56 exemption who were just it was before we did the group therapy and uh for people who are too unwell to actually participate in the group therapy um so i've had about five patients where i've done them at home and what insurance are they using like what type of insurance are they actually getting so so i'm just using my professional liability insurance and the patient is in their own home so they're completely like i'm not paying for that venue right so i don't know so they don't need to get insurance realistically if they don't want to not yeah that makes sense i would love to just uh note the time and just respect that if anybody needs to leave um we're almost through this is an amazing discussion and i have a couple more questions here val about um the dosages of the substance that you're asking for if you have time to dive into these before we wrap up okay um so really uh synthetics come in 25 milligram capsules that's been what the studies have been you know been using is just one 25 milligram capsule so um so most the producers like even the the botanicals um like luminous would actually dry mushrooms and package them where they know that package of mushrooms contains 25 milligrams of psilocybin then they do have different dosage forms like 10 milligrams 20 milligrams for 25 milligrams 5 milligrams sorry um but the uh like i said the um flygen is producing it in powder though and then they will and they can't encapsulate it at this point that i um that i know of and then uh filament is freeze-drying their extract and putting it into capsules saying that there's 25 milligrams in this capsule so we're not doing milligram per kilogram we're just now for us we've been allowed for our last cohort of patients we've allowed them to make a choice because we used actually whole mushrooms that were verified by mycologists then we let them pick between 2.5 and 5 grams of dried mushroom which would be the equivalent of like 12 and a half to 25 milligrams but i mean we didn't test the this little cyber amount and that obviously in the dried mushrooms we just had them donated through a through a um uh just not a producer but just a a um individual who who was trusted by the team who grew them themselves do you know the cost of that val are they are we we're asians at this point no uh saigen has is providing for us free of charge and filament was prepared to provide for us free of charge and um and we and the first cohort had a donation um so yeah people the the companies they you know what's in it for them is if they can provide um certain patients free of charge in the early days they get they're asking hey can you can you do some vitals before can you report back to us about um the effectiveness or adverse effects like this is post marketing surveillance right and they're all about doing that so you know if you have a really good relationship with them um i think in the early days we'll be able to access free of charge on the street um you're looking at about you know 40 or 50 like a dollar a gram i would think uh for a dried mushroom um but you know as times change i think that might go up as we start seeing demand go up well it feels like we've answered a lot of the questions that were asked in the chat before we wrap up i'll just do one other uh ask of the group if there's anyone who has any dying questions they really want to ask before we wrap up oh amazing that was such a good discussion val thank you so much for sharing your experience and for like paving the way val for physicians in canada because if it wasn't for you working with us at therisil i don't even know where we would be and what we would be doing and since the beginning you've been here advocating for this publicly and advocating for the patients that you support and i'm i'm seeing these patients come to me after they've done the my community journeys and expressing like how healing and how safe the container is that you're providing over there and the work that you're doing so i just want to send you so much love and appreciation for everything that you do val i know you've been really busy yeah and everyone say it's not paving the way it's shoveling the way right on here thank you everyone for being here thank you for supporting psilocybin access thank you for being being interested in it thank you for advocating thank you for speaking about it thank you for supporting your patients thank you for learning with us um and everyone will receive an email recording of this webinar which will also have that prescriber survey that i would really appreciate if you could fill out i'll take you two seconds but it'll be really informative for us um and keep an eye on our newsletter and our websites for changes in our clinical protocol that'll guide prescribers to navigate these new processes um and final sign off from there hill is we're going to just keep advocating for psilocybin to be accessible uh including regulations like we believe that this should be available with uh prescriber uh being able to provide this for any patient in medical need and not just those who have someone who can navigate sap and meet these criteria so keep following us to learn more and keep supporting us and if you want to reach out to anyone on the team our emails are all our first name at theracle.ca so if you want to contact any of us thank you so much everyone and i hope you all have a wonderful rest of your day