Word count: 21,732 words.
See part 1 of this transcript here: https://weedpress.wordpress.com/2018/12/10/transcript-from-medical-cannabidiol-advisory-board-hearing-august-3rd-2018-ankeny-iowa-transcript/
Audio courtesy of Iowans for Medical Marijuana, retrieved from https://www.iowamedicalmarijuana.org/Iowa/MCAB_2018_08_03_2
Note: This is a very much unpolished transcript. This will be reviewed and clarified by others later on when we have more time. For now, the information is so important, and the transcript close enough to accurate based on the sometimes hard to hear audio recording due to doors slamming and lots of things happening, we are posting here for the reader. Take special note of MedPharm Iowa’s information at this meeting regarding product formulation and similarities in chemical makeup to more marketed brands like Charlotte’s Web or Haleigh’s Hope, meaning Iowa has the same medicine those “Nike’s of Marijuana: have patented and distributed through their CNN marketing channels.
Mod: With a CBD focus, now I’ll open with some other things, so I’m going to make a few points as will the rest of our speakers. Hopefully give you an indication of what the thousands and tens of thousands of people that we represent for prevention and treatment throughout the state, there is a very very serious concern, that’s why it’s being touted as a miracle, a miracle cure, a miracle drug, not unlike what opioids were once approved as a cure for pain. They have a lot of dangerous and unintended consequences. I think that’s why we’re here today.
That being said. We know that we can’t expect marijuana to perform medical miracles, and that the message from a huge reviewist, again, all in the Journal of American Medical Association Publications, a huge review of 79 clinical trials that are taken between ’75 and 2015, assessed the merit of taking cannabinoids, the active component in cannabis to treat different health conditions. We have over 23 states, almost 30 states now have medical marijuana legislation to treat things for long term pain and sleep problems and muscle disorders. But when we examine the evidence, that the drugs are actually beneficial, we found little to suggest it is. It doesn’t mean we shouldn’t be innovative and think ahead. But most trials that have reported an improvement in symptoms of cannabinoids compared to the control groups didn’t usually reach statistical significance. So I’m concerned that when we start expanding the horizons from CBD to THC that we take some very very strong and inherent risks when dealing with a psychoactive inhibiting drug under the pretext and context that CBD is somehow married to this, lends credibility to it medically. Cannabinoids have been generally approved for medical applications without having to go through strict proof of benefit trials used to judge other medicines. We believe it should be evaluated the same way as any other type of medical treatment. And it’s important that all interventions are judged by the same standards as should the benefits be. Adverse effects of cannabinoids should also be considered in light of that evidence.
There’s a failure to test the drugs in the same way as others through the Food and Drug Administration which is in our opinion putting the cart before the horse. If a state’s initiative to legalize medical marijuana is merely a veiled step to allow access to recreational marijuana then the medical community should be left out of the crosshairs. And again that seems to be the crux of this CBD THC debate. Because we know there’s risks. We know that non-FDA approved CBD oil applications, especially the research that we are seeing from the Children’s Hospital in Denver, have resulted in significant problems, even in the target populations with benefits for seizures where CBD is the most vital. And that’s without THC. The problem we have, is the systemic lifespan comparing how long the CBD lasts in a child’s system and how long THC is active in a child’s system are readily different. And doctors are concerned there with the fact that there is a dangerous potential for toxicity that instead of children being relieved of CBD they’re being drugged by THC. And I love things for pain and short term memory loss, there’s no doubt that short term memory loss can help you not worry about your pain. I remember what they showed Mr. Olsen, citing, he himself said that short term memory loss is one of the biggest side effects of marijuana use. I assure you if you forget you’re probably drugging yourself into that situation it’s not necessarily a solution.
That being said. Since we are on course to provide access to CBD to Iowans, we have felt that the criteria that we believe in and this commission has really strengthened have been important. One being maintaining strict limits on THC content at three percent or less. We know that FDA approved drugs can easily meet and even improve that standard. We know THC is dangerous and psychoactive. It’s also addictive. And a little addiction can go a long way as we’re learning from the opiate crisis. A few medicines that have addictive components, and those that do, have proven to be very dangerous. So we want to make sure we maintain strict quality controls and security standards, specific goals for both CBD content, and limitations on CBD content. We want to see continued limitation of any and all advertising as doctors should be the authority on treatment not the court of public opinion, or public interpretation for that matter. We hope that this Board establishes standards for prosecution to the fullest extent of the law for people who abuse the privilege of CBD based medications to create pathways to addiction or recreational use and abuse. And we certainly want everything in child safe packaging that might contain any hint of contamination with THC. So, in it’s mission of managing CBD, based on non-clinical trial tested products, as enforced by our Legislature, under your direction, we have effectively bypassed the FDA, an organization by the way that may be responsible for the most powerful effects on healthy, uh, healthy limits on medicines. They Made America Great in terms of medicines. But ignoring the fact that some of these products are now firmly within the grasp of FDA approved distribution, we’re faced with what may have been the intention of bypassing the FDA in the first place. To build a marketplace for THC. An addictive drug that’s being used more widely recreationally than any other drug we’ve seen. If that is the truth, then, we have a problem. If THC becomes the bellweather drum for all future CBD based medications, all of the compassion, and all of the interest we had in helping young children with seizures will be thrown out the window for an entirely different business. So we’re really supportive of what you’re doing with CBD. We’re just worrying that that is going to be corrupt for THC. Because those same people that are coming to you saying they are for THC are now saying that the business model they lobbied for for CBD years ago, is not viable, because they can’t make enough money to make it work. That’s not our problem. Our problem is to give children access to CBD. So in this case we can not trade a compassionate mission on which the risk to provide CBD to children was undertaken by Iowa, to break federal law and provide the compassionate benefit of CBD to Iowans by tainting the important efforts of this commission with the altogether different drug business associated with THC, the psychoactive and highly addictive drug that is proven to contribute to substance abuse disorders, especially in youth, as a direct tie to increased in opioid abuse later. There has been no substantive evidence that says opioid use reduction over time is relevant or even documentable. This is all anecdotal. We need more research. If it’s true, we’d love to get on that bandwagon. And today, there is no good evidence to say that it’s true.
And, this genesis, of this evolution of THC and this mindset that it somehow provides miraculous cures, is not unlike another well-known epidemic, the opioid epidemic. Which case the advocates are now trying to hitch their wagon to and say this is now an alternative. Well. That vastly understated risk associated with addictive and psychoactive drugs, like THC, we’ve seen the result of that with the opioid epidemic and we’d hate to see it repeat with that social costs, human pain and suffering (unable to hear remainder of sentence). I’d be going for a long time. Jennifer I’ll give it to you.
Jennifer: Ok. Let me just make a brief and pretty informal handout and I also have a copy of the Office of Drug Control Policy’s handout that they had back from last year. It’s a little bit out of date so I put some new information in my handout. So I’m Jennifer Neusmann, I’m an Advanced Prevention Specialist. I work with at um, ASAC, and in treatment, I work in the treatment office, but I’m working on the prevention side. And um, anyway we are, I run a coalition in Jones County, and we work on underage drinking, tobacco use, prescription drugs, opioids, and marijuana. And that this year we just got a grant on that as well. And so I wanted to tell you I’m also on the Executive Board for the Alliance of Coalitions(?) for Change, and I want you to know that we are all for the research and reducing the hurdles of research for cannabinoids and marijuana cannabis plants, to help with conditions for people that should be continued vigorously, vigorously, and I refer that Office of Drug Control Policy flyer that says back in even 2015 the National Institute of Health had 281 cannabinoid research projects going on, and many more since, because in 2015 also the HHS eliminated a bunch of hoops so there’s even more happening now so I didn’t get that information updated yet, but ASAC’s position has always been and continues to be that we should follow federal law in this regard and wait on the science making sure and using the FDA approval process with double-blind clinical studies to improve medicine. We’re, you know, one of the reasons we’re so strongly in support of that, we know that when the double-blind clinical studies are so important because of the placebo effect and especially when we’re talking things, depression, bipolar disorder, different things like that, the placebo effect can be thirty to fifty percent people thinking that’s working for them, and that’s great if people think that’s working for them, but you know we wanna make sure that we’re not like, wasting people’s money in a sense with all of our costs and expenses, or if it’s really no better than a placebo. So that’s why those are important.
This process, as Dr. Smith has already said, is happening for Epidiolex, for intractable seizures, and very likely will be available this fall, in all US pharmacies, as soon as the FDA gets the rescheduling done, which you talked about, which should be done before the end of September because you have 90 days from June 25 when it was approved, so it’ll be legally prescribed by prescribers, and most likely be covered by, hopefully, by prescription insurance coverage or at least for those with LGS or Dravet syndrome. So, I am not, I want to put in a disclaimer first, I am not at all a doctor, I’ve just been studying this issue since 2010, and um, so, I know the doctors know so much more about this, I just wanted to say that, but it could be off label prescribed for Epidiolex, possibly as well. And I might even say Sativex today, but I’ve been saying Sativex for all these years, reading it and not even – anyway, how it’s even pronounced for sure, but um, that is in the FDA as she said, I won’t repeat all that, clinical, processed for MS spasticity. And I put the updated chart from GW Pharmaceuticals in the handout that I created there and that the Office of Drug Control Policy just made in black and white, that one was from 2017, so I put I got the chart right off of the website, their website that says all of the different developmental pipelined cannabis derived drugs that are going through that they have in the process now. And I always think it’s important to remember that Sativex in the US trial made it to phase III and in phase III they found out it did no better for cancer pain than the placebo. And they ended up, they sent it back to the trials, so it’s now in phase III for the MS spasticity. And that has been in other countries, has been in what has been proven to work so hopefully let’s have that very soon around here as well. But we already talked about that, I just wanted you to see, some of those, I don’t have a powerpoint so just make sure that you know that there’s studies being done for schizophrenia right here where they’re in the trials already, um, and I’m gonna butcher these, but the brain cancer that’s the glioma and glioblastoma, and you guys can do that so much better than me, and um, perinatal asphyxia, which has that long much longer name. Previously we were talking about that (?) spasms. Autism, that’s neat to see that that’s on here as well, and tubular sclerosis. So that’s awesome that those things, and probably more from other pharmaceutical companies, but that’s what I know, and so um, anyway, I wanted to say that we know that even the discussion. Well, I’m not going to talk a lot about this, you can read it, because I don’t really want to waste — but I wrote it out as far as what we are really concerned about for youth and the youth data. You can, the next, second page of my handout after the colored, first chart, you know we know that the perception of harm is decreasing greatly for marijuana for youth. And basically an equation for increase of youth use or any substance is reduce the perception of harm and increase the access and you’re going to have increased use of marijuana. Thankfully right now in Iowa we have a very low youth marijuana use rate. And we’re one of the lowest in the country, and that’s great. And we’ve stayed the same the last few years even though our perception of harm has been going down. But we’ve been going down in underage drinking, but it’s stayed the same on marijuana, we’re quite not clear what we’re going to see on this next youth survey, it’s 2018, we won’t see what’s on there until partway into mid-2019. Anyway we are concerned about that. So, there’s a perception, you know, that kids anymore, that marijuana is just healthy for you, and that it is not dangerous at all. And that is just not true. And we’re concerned about that. And most media as to the perceptions and misperceptions that marijuana can be of no harm, and misperceptions even for the public, with headlines and brief statements that are less than accurate. Most of the public is sure that what is coming in Iowa is only cannabis oil or CBD oil and I know this because I talk to the public all the time. And they’re like oh, but we’re just, we’re just getting CBD oil only, and that’s because as stated on local TV stations this past year, our local KCCI, MedPharm Iowa will obtain an (?) property from MedPharm Colorado to innovate manufacture and formulate CBD, it’s still on their website. CBD is an extract of marijuana use to help with pain. That extract does not contain THC, which is the component of cannabis that produces the high. That was right off of the website. You know, there’s no THC. So that’s what, people, kids, this is what we’re having in Iowa is no THC, don’t tell me, for sure. And that’s not true, we know that, because we have one of the forms being called Elevated THC. And in fact it’s only .3% CBD because we didn’t think we’re going to move the level of CBD, which is what Prevention had originally recommended, but the public, and even some legislators, my own legislators, thought that it was only going to be in the oil form, and not vaginal, and suppositories and transdermal patches and nebulizers – nebulizers are under the other forms – so Prevention is thankful that it is not in edible forms other than the tablets and capsules.
Though we are concerned with how often consumers with medical cards will be allowed to purchase. The Powerpoint links that I had said a 90 day supply of each of the 11 or so types of products can be purchased from A, a dispensary, at one time. I’m not sure if that is correct, that is the exact definition, there’s more of a definition, is that possible that someone could go in multiple times within those 90 days and get multiple types of a product at a time? And even visit multiple dispensaries, I don’t know, I’d like to know that. So, um, and I also wondered are we beyond saying each product, because we don’t have, can we have a lack of, can it be in each part level, so can that be four times, so if we have four different levels of each product, I don’t know if you want to answer that or if you want to wait to talk about it later.
The other thing we are concerned about, is I want to tell you why we’re concerned about THC, because of what it can do to the developing brain, we just don’t want to end up with more access and you’ve seen that. In the eight other states that have legalized marijuana they started with medical marijuana. We aren’t one of the 30 states that yet have medical marijuana we just have a CBD program, along with the other 17 states, but along with the developing brain, it definitely affects not only definitely addiction, much higher than the regular population, but serious mental health conditions, academic and educational success. My son said make sure and tell them kids don’t want to do school, or finish school at all if they’re on pot. And intellectual capability. All of this is more concerning if the THC level of the products is raised and if more conditions are approved without the science there yet, resulting — and I mean the science of the double blind clinical trials – resulting in the products being in more homes where youth are and where other family members have access.
We are concerned about increased drug driving and other negative decisions made by both adults and youth when under the influence of THC, affecting all folks on the roads.
There are also the confusion of the over the counter CBD oils. What, confusing the kids and the public even more. I just found out that we have a local in what county I won’t say but near of us, the CEO of the local hospital and a nurse practitioner have all been a spa and they’re selling the CBD oil. And I’m like, how would the public not think this must be healthy? The chiropractors offices have it. I’ve seen the natural health food stores, I’ve seen at one of the natural health food stores that I no longer frequent but, I can go to a different one that doesn’t have this, but saying on their website that they are legal because they are made from hemp. And, you know, what are we doing about this situation in our state when we have all these products out there which will be similar to what we are producing here, the lower level ones of the two lower levels of the CBD products we are going to be having out on December 1st. Where is this program going, if more THC and more conditions are approved? With increasing any addictive drugs availability, we end up with other kinds of drug use. Colorado the place where you would say is you know, really the experimental state of watching how medical, started, they have now an increasing, people have medical access like no other there, right? And yet they have, um, an increasing rate of opioid overdoses and deaths, and, an increasing rate of meth overdoses as well, we have a meth problem here too, and so when you have one drug you’re having more, and we’re not really talking about prevention anymore, we need to talk about all, all substances, not just that one just begets another, when you have hard drugs. And so, so many young people are addicted to opioids, are addicted to opioids, and then first we watched the chasing the dragon video, it talked almost every young person that had, had overdosed but still was alive to be on video you know it started with marijuana use. And so it’s kind of a double edged sword because it sounds like there’s some potential for some you know, careful if it was through the scientific we’re all for it but the opioid CBD and that type of thing isn’t helping with reducing the opioid use but, but it’s also going to be the other way around. If we end up, if this program ends up increasing THC we kind of run a pathway for legalization and we end up with more opiates, and you know, that’s kind of what I’m concerned about. And I want to say, you know, legalization is not happening inevitable in Iowa. You know. A lot of people think that and I wanted to say that in a public place. It is not inevitable. It has to be work. We’re not a referendum state so that helps a whole lot because there’s not as much money thrown into fund um, changing the public’s opinion on that. Anyway.
Guy: If I could interrupt you on that, are we willing to, we only have so much time scheduled for this.
Jennifer: Yep. I know. Ok, so. And I gotta get to lunch. Right, right but we are ahead of schedule. So if you want to turn the page there, I have the heroin use being part of a larger substance abuse problem showing the link, just a link though, between marijuana users being three times more likely to be addicted to heroin. Those who are addicted to marijuana is three times more likely to be addicted to heroin. Even worse for cocaine and of course prescription drug painkillers are four times more likely. So just a caution on the PTSD and bipolar. I wrote a little bit about the data right there in remembering that placebo effect, especially if more THC is allowed, it could end up being more harmful. Maybe there are some things that are better at getting to the root of the problem like EMDR and those kinds of things for people with PTSD. And I just wanted to link to the bipolar, is that, I also have the experience of my own son who um, when he was upper high school he um, he started using marijuana a little bit and he ended up at college really using it a lot. He was starting to have some issues at upper high school as well with mental health around that same time. He’s twenty seven now and he’s now recovering from both mental health, or in recovery I should say for mental health issues and substance use disorder. But um he you know he started that with marijuana, and he even said, you know, that he knows that that’s, the heavy use of marijuana is what, we have mental health issues in our family, and we went through a lot for the last seven years. When he turned twenty when he got the diagnosis of both marijuana use disorder and bipolar. One doctor said schizoaffective disorder but he’s doing well, but he just wanted me to say, he wanted me to share that as well that, you know that, some, for some people, it’s been very hard, he’s had a lot of suicide attempts and he actually a couple years into his bipolar diagnosis he, you know, tried to self medicate with meth, it’s just been in and out of treatments. It’s just been very real for me as a parent, this connection, and why I’m so passionate about marijuana. I was before, actually, but um, anyways, so.
And Linda? Ok good you did make it. We told her 1 o’clock so. She’s right on schedule. So, I wanna introduce, I know Linda, but um, if you just want to talk for a few minutes. One minute. One minute.
Guy: We’re running short. So,
Another guy: You want us to defer the public comment side?
Guy: Well, we’ve already signed up, can I give you Linda, and you like, five minutes combined, so we can wrap this up and keep moving? Is that fair?
Linda: So, I’m Linda Weir. I, as a nurse of thirty years working in emergency medicine, also in our poison center, my perspective may be of consideration. I’m also the mother of a twenty-four year old who overdosed on fentanyl last year, and because of that have started a group called PAH, Parents Addicted to Hope. So, I feel like I have a very full view perspective of a lot of what’s going on with marijuana use and how that ties into like you said all of these substances ultimately that we’re talking about. And the effect of how all of this combining comes together not only as the mother of someone who started on marijuana and then swiftly moved onto many other things eventually heroin and he was killed by fentanyl. I also sat on the phone and in emergency rooms and listened to patients you know tell me the nurse, will tell the nurse anything. They don’t talk to the doctors near as much or are not near as open, and I just have such a different perspective than what I hear comments of so many people saying. And as a nurse I took an oath to try and help save people, to help make their lives better, and for that reason I’m not standing up here saying that I am against the use of CBD to help people with certain medical conditions. If there are rules and regulations in place to show in fact that this person has gone through steps one two and three, is not effective for them, someone has been monitoring that full succession, and then in giving them a prescription cannabis, there also is monitoring and supervision of you know how is that actually effecting and helping that person’s condition, you know whose responsible for that, and what are the guidelines and the criteria that we’re following to monitor that, that’s of concern to me. And also having worked at appointment center, and I know you’re in a hurry, I want to consider safety of children. We know by research, that by 2 months of age, all children, not all, most children are able to master opening a child resistant package. We’re talking about giving a 90 day supply of a controlled substance that’s which, we basically are allowing the patient to control or figure out on their own, because there is no set amount, um, you know in giving that to them in such a large supply, it’s hard for someone to monitor the amount they have gotten from say a dispensary and know in say 60 days oh gosh, some of my medication is missing, I wonder if my kid got ahold of it. I wonder if the neighbor came over and took some of it. Um, they’re probably not going to know that until they get closer to their 90 day period. And there is not enough research and science to support and back what exactly the effects are of this are on children, I’m particularly concerned about younger children because when I see things like Charlotte’s Web which comes in a cute little package with a squirty bottle in it um I can tell you a two or three year old is very infatuated by that and will sit and squirt the whole thing in their mouth. That’s what happened with Tylenol years ago when we took away the child resistant caps. So, I’m not asking you to, you know, I think in today’s world when you make a statement you automatically create a division. And as a nurse I want to help people, but I want us to step back a little bit and think about, you know, what are we doing here, how is this actually regulated, supervised, monitored, and what are the effects ultimately of opening this Pandora’s box, because we know what it is, we did this with opiates years ago. It’s opiates, they’re safe. Doctors can give them out and it will cure everything under the sun and no big deal. Um, and we know what happened with that. And um, you know, like Peter said, this is anecdotal, this isn’t scientific medicine, enough scientific research and evidence to show not only that the side effects but the helpful points of giving marijuana medically so, if you’d like to talk to me more, you can get ahold of me.
Guy: This is actually the public comment period so I’ve got twelve people signed up on the list. Is there anyone else that we missed that would like to speak?
Audience member: Yes please.
Guy: Ok. We’ll go get, get you –
Lady: If we could, originally we were told 30 minutes, I was gonna say, if we were allowed to just finish —
Guy: How about comment period start at
Lady: And I know someone else is coming through but they thought it was starting at 1.
Guy: For the audience, I can’t help the time. Sometimes we get done earlier, or later, so we’ll save your comments for the public comment period.
Lady: That’s fine.
Another guy: And we do thank you. We just have so many, thousands of procedures on states so it’s hard to distill things into a short enough of a message.
Guy: I understand. Ok, so the next item here is the public comment period. Just gonna kind of go over the rules and set aside some time today on the agenda to allow members of the public to address the board. All speakers are asked to keep their comments to five minutes or less. Persons interested in speaking should have signed up on the sheet. We’ve got a couple additions. If you have not done so, we’ll get you added. Then when you approach the podium, please state your name so we can write that down, and as we get close to the time limit I will hold up the stop sign to signal that. If you wanna have a seat, we’ll get the first person up that’s signed up. His name is David Barnett. Are you ready?
David: My name is David Barnett. And I have multiple sclerosis. Um, I have been through numerous medications that are normally prescribed for neuroplasticity, neuropathic pain, sleep issues. All to help me enough, I wasn’t coherent enough to function. It was, you know, I was in either a lot of pain, unable to sleep, or, you know, in a comatose state. Um, I used alcohol to help deal with that for a long time. And that ended me up in mental health care for a while. Inpatient, Iowa City. After I left there my wife convinced me, you know, to try, cannabis, for my symptoms. I have not drank alcohol since I left. My sleep with cannabis has improved. I was on Adderall to help with my MS related fatigue. With cannabis and helping my sleep I’ve almost completely eliminated that. Used cannabis to also help with my spasticity and pain for that which is what, made it so I couldn’t sleep as well. And all this said, my doctors know this, that I use it, I’m open to my doctors about it, and being a patient at the VA, they cannot fully approve or endorse but as far as they legally can, they support my use. They say they wish they could fill out my paperwork for it, but because it’s the VA they can’t. Which is one issue that I wanted to state to this board is, you know, it’d be helpful, because the politician’s are gonna listen to the Board more than just a random person. I haven’t heard you say something to them about getting VA patients to have access to the program. Because I’m 100% disabled (34 minutes 14 seconds) and I only see the VA doctors. They can’t sign anything. I know other states have programs where you can send in your VA medical records and have them reviewed to show that you have the certifying condition. That would be one thing I find very helpful because it’s in all of my medical documentations that I have spasticity I have the MS and everything, all of the medications that I’ve tried. But my doctor can’t sign the form saying yes he has MS with spasticity. And then there’s a few other points that, because of the other speakers I’d like to uh, hit on real quick.
I’ve seen bipolar disorder was to be discussed later. Uh, my wife is diagnosed bipolar. She’s had multiple suicide attempts due to her prescribed medications. And since she started using CBD between 150 and 250 milligrams a day of just straight CBD, she has discontinued klonopin, gabapentin for her restless legs and Trileptal for her mood stabilizer, all of which are very addictive drugs at very bad side effects for her. She was extremely dependent on the klonopin. If she missed a dose, if she was late on a dose, it was, I was scared for her life. And with CBD she has gotten off those three medications and she’s better than I’ve seen her in her whole life form the day I’ve met her. So. Personally that alone proves enough to me that it helps the bipolar. And then for the placebo effect, I didn’t go into it believing marijuana is going to help me. It was kind of a last ditch effort.
Guy: Thank you.
David: Oh. And one other point, I want to state.
Guy: I gotta keep moving on, trying to keep everybody on schedule.
David: I’m sorry. Can I just have one second?
Guy: Your time is up I’m sorry. Mr. Bolkcom is up next.
Joe Bolkcom: Good afternoon. I am State Senator Joe Bolkcom from Iowa City and I’d like to start (37 minutes 19 seconds) by thanking the Deputy Director Reisetter and her team at the Iowa Department of Public Health for the amazing work they’ve done in trying to implement this law. I’d also like to thank the members of the medical advisory board for your service in helping stop the suffering Iowans. And I’d also like to thank the manufacturers and the dispensaries who have come forward to invest in Iowa and their commitment to help people that suffer.
I’ve been a strong advocate for a comprehensive medical cannabis program over the past decade. Since 2014, I’ve spent literally hundreds of hours studying what’s working across the country to provide benefit to suffering patients. I’ve met dozens of Iowans who suffer from debilitating conditions who have doctored with the best, have taken the most powerful drugs, and have petitioned our government for access to safe legal medical cannabis. And really those are the stories I think of those patients that have brought us to this point today after all that has been, is why we are here. You really have your work cut out for you to implement the worst medical cannabis law in the nation. Unfortunately a defective law that come November, unfortunately a defective law that come December 1st, will leave thousands of Iowans to continue to suffer with debilitating conditions that could be eased by access to medical cannabis, available to more than 150 million Americans in 29 other states. The false hope that this law creates for suffering Iowans is both cruel and unnecessary.
One of the top responsibilities of the Iowa Medical Cannabidiol Advisory Board is to make recommendations on how to improve the program, something I hope that you will do. And as I parenthetically will suggest, my knowledge and involvement in this has largely been driven by the patients I have met. Suffering people across the state. And I hope that this board will have more structured time on your agenda in the future to hear from patients. Cause you’re gonna make a lot of decisions and recommendations on how to benefit patients, and I think you need to hear from them as you get into this, because they have a much different view I think on that whole issue.
Here are four things I think the Board should recommend prior to the 2019 session of the Iowa Legislature.
Number one: remove the restriction on THC content on medical cannabis that will be available to Iowans. Iowa is the only state with a comprehensive program that restricts patient access to the benefits of the entire cannabis plant. THC provides therapeutic benefits necessary to treat most of the medical conditions approved in the Iowa law. Without abolishing the THC limitation, patients will simply be wasting their money on medicine that won’t help them.
Number two. Recommend more debilitating medical conditions be included in the program. Iowa is again unnecessarily restrictive. Iowans suffer from many many conditions that could be benefitted by having access to medical cannabis. There is no state interest served by forcing Iowans to break the law, or move out of state to get the medical care they need.
Three: Patients need more convenient access to medical cannabis. Having only five medical dispensaries located in the entire state is woefully inadequate. There are more than eight hundred pharmacies in Iowa. Sick patients will find it difficult and costly to travel long distances to get the medicine they need. The Board should recommend at least 15 to 20 more locations.
Four: Patients need affordable medical cannabis. This is a cash program. There’s no private insurance coverage, no Medicaid, or Medicare coverage to help patients pay for these medicines. Many patients will be able, will be unable to afford medicine. The most cost-effective form of medical cannabis is actual flower from the plant. That’s because every time you reprocess the plant you add expense. I encourage the Board to reconsider your opposition to allowing patients to have access to plant flower. This is the most cost-effective form of the medicine. Patients want access to flowers. It should be available to Iowa Patients just like it is today to millions of Americans in 28 other medical cannabis states. As I’ve said, you have your work cut out for you. Iowa voters have their work cut out for them. That’s because the Iowa Legislature and the Governor have the sole authority to fix this program, and if Iowans are going to fix Iowa’s broken law, we need to fix the Legislature. In November it’s time for folks to step up and pay attention to this issue. Let me conclude by saying thank you for your service, you have a big job ahead, I look forward to working with you and other members of the General Assembly, to make our program help folks that need it. Thank you.
Guy: Thank you. Kim Loeffler?
Kim: I’m Kim Loeffler with the Loeffler group. I’m also owner of the Corner Store Apothecary. I want to echo what Mr. Bolkcom said. Thank you for your service and all that you are doing for us. And again for all of the other people here to advocate for CBD.
I just want to touch on a few things. Basically it was, my main reason for signing up, was to, just to ask again to add more conditions. And I see the three that are on here and I just wanted to advocate for those three, the fibromyalgia, the PTSD, the bipolar, also the colitis. I have seen several patients and customers of ours been able to get off of medications. I too am a nurse, I have been a nurse in the emergency room, orthopedics, counselling services, the University of Iowa student health where we did counsel people on abuse of drug and alcohol. We’ve also uh, been out to DC recently, and got a lot of education. I’m out there pounding the pavement. I’m visiting these dispensaries, I’m visiting these doctors, I’m visiting these patients and all these advocates in other states getting a better education first hand. Not statistics that I read online, not statistics that are handed to me or advocates out there that are just, there’s a, I guess, my biggest frustration I should say is education. Education education. There’s all these statistics, here here here here, you didn’t need to show statistics today. Let’s talk about these people’s lives, and how it’s really affecting them. I have Ball pain cancer center in Cedar Rapids, I have Ball pain clinics in Cedar Rapids, sending patients down to us, helping us get them off opioids, helping them wean off. We go out, we advocate and we educate. I also believe there should be no THC content, cap, for the medicinal part of it. THC, and this is my biggest education, if this is the takeaway, the THC is not the psychoactive things. When they were up here talking about THC, do you know that’s to a drug, to a brain? Do you know what a seizure does to a brain? You know. It’s incomparable. I have been out to many hospitals, I have been out to the Mayo clinic. I have been out to Denver, to the children’s hospital out there. I have walked the halls. I have talked to patients. I have seen these kids in fetal positions. My husband’s 6’4”, weighs almost 300 pounds, on these same medications that these kids are on that are small. As a nurse, I thought that these kids were in these fetal positions, in wheelchairs, and all these were cognitive problems due to the seizures. No. It was more the medications. See these kids getting off their gabapentin, seeing them getting off all of the medications for seizures, and seeing them walk, talk, and their quality of life is so much better.
You talk about placebos, yes, there’s a placebo effect to everything I believe. But, tell that to a child who has no idea what a placebo effect is. Tell that to an infant who a parent who sees a child recover within 15 seconds from a seizure by using this medication. It is a plant based thing that God put on this earth. It is natural. If you do the research, if you actually do the studies, that is my biggest advocation for it is, CBD versus THC. Study it, go out there, walk the pavement, talk to these people, talk to doctors, go to other hospitals, clinics. Dr. Josie, who left the University of Iowa, she is now out there in Denver. Wonderful strides. The doctor who was here earlier, who gave the, um, I’m sorry, I’m just so passionate about this. I have so much to say and I’m trying to keep it small. But um, wonderful. Everything she is saying is what I talk to people daily about. The receptors, the cannabinoids, everything that is up there.
Out in DC in Congress last week talking to people, you would be amazed. I’m (unintelligible) week of hospital, they are using CBD. This is not public known. They are using CBD products for PTSD, for all, for, you know, the military and stuff like that. This is not publicly known. There is so much out there that is not publicly known. You don’t know this until you go to these places. Start talking to people. Start talking to Senators. I have law enforcement, senators, doctors, lawyers, using our products, and we educate people on our products. I am full on, here, to answer any questions, give you any um, statistics that we have first hand from our patients and customers that we see that have been able to get off medications. It is just astounding, and um, somehow we are going to start working with the University and the doctors in Cedar Rapids as they continue to send people our way and get an idea of more of how many people are coming to us, how many we’ve seen weaning off medication. My husband’s off five seizure meds, two diabetic meds, two heart meds, driving seizure free, and my husband is a huge advocate for that. And we hope to be down here and give our story and give more information at a later date. Thank you.
Guy: Thank you.
48 minute mark
Philip Daughty: Hi I’m Philip Daughty. I’m the registered lobbyist for Have a Heart, which won two of the dispensary licenses earlier this year and we will be open, we’re ready to be open on December 1st, in Davenport and Council Bluffs. And that’s the end of me saying anything corporately. I want to talk to you all as a longtime medical cannabis patient in Washington state. I also had the privilege of being able to write the collective gardens law which we operated under for about five years. The law you got here isn’t gonna work for people with chronic pain. Won’t work for me. It’s because of the THC cap and I want to try to approach this with you a little differently.
I need to get about 250 milligrams of THC into my body every evening or I’m in bad shape. I don’t medicate during the day because I have to do things like drive cars and have complicated conversations. I have to consume about a gram of flower a day to get what I need. Somewhere between seven and ten bucks, pretty much affordable. I have to consume probably about ten times of the amount of product in Iowa under the current program, I don’t even want to guess at what that will look like expense wise, but it’s probably going to be over fifty bucks a day, and I don’t think too many people can handle that. So I really wish you guys would uh, reevaluate the situation with the THC cap.
I completely agree with Dr. Smith on redefining pain, particularly getting rid of the requirement that somebody has to do a trial of opioids or something first or creating a situation where that’s the case. When I became a medical cannabis patient ten years ago I was offered opioids. I rejected them. I wouldn’t take them. They, I watched too many people die. Just, straight up. And these were people who were being taken care of by docs. I feel very strongly that I, I really hope that you recommend to the Legislature that they add PTSD. We added it to our list of qualifying conditions about four years ago in Washington and it’s proving to be quite helpful. Leave it at that.
Realistically for patients, particularly for chronic pain patients, we need to get relief as quickly as possible. And the reality is smoking cannabis is the quickest method of getting it there. It crosses the blood-brain barrier very quickly. You saw what Dr. Smith’s number she put up, and I can support those based upon my own experience. I hope you’ll just reexamine that situation. There’s some pretty good research out of UCLA on are there any airway issues created by smoked cannabis? And remarkably enough, pretty much not.
Like Senator Bolkcom, I would like to see patients more involved in the process here. I don’t quite know how you engage them and get them in. But as he said, you’re going to be making a lot of decisions that impact their lives and you should hear from them.
So, I disagree with almost everything the AC4C people said. There’s one place where I agree with them and that’s on packaging. We found in Washington state that we had to create rules over the last few years that banned the like, cartoon images, or bright colors, or stuff like that on packages because we did have some unintended consequences when 502 passed, and that was, will sloppy parents leaving stuff laying around, will little kids get into it because it looked attractive? I think we’ve gotten rid of that problem now, and so if you’ll look at our liquor board’s rules, that we write right there, um, I’m not even going to rip up some of the stuff that AC4C says. I’m just going to leave it alone. Thank you.
Guy: Thank you. Dillon?
Dillon: Hello and good afternoon. My name’s Dillon and I am a master’s student in psychology, and also a cannabis user. I’m an Iowa citizen in support of the use of CBD for ulcerative colitis, a chronic gastro-intestinal auto-immune disease similar to Chron’s which the Board has already approved as a qualifying condition for CBD. I come before you today with a petition to add ulcerative colitis to the list of qualifying conditions, based on medical science and I’ll also tell you a little bit about my own experience using CBD, just cannabis flower for ulcerative colitis.
I suffered from a flare up of ulcerative colitis a little over a year ago. It was the worst time of my life. I suffered from abdominal cramps and was in the bathroom for hours a day for a couple of weeks. As a college undergraduate I was absent from my class and job and during most of my flare up I had no idea what was happening to me. As a previous cannabis user, also a side comment, I used cannabis since I was a teenager and have succeeded in my education, I don’t think there’s, some people are predisposed to addiction, but it doesn’t mean everybody who tries it in their teenage years is gonna become an addict and lack any good sensible education.
As a previous cannabis user, I wondered if cannabis would help relieve my pain. Indeed it did relieve my abdominal pain and helped me get to sleep at night. Cannabis also helped me cope with the mental stress of having my body taken over by some sort of disease that was yet unnamed. A colonoscopy later, the doctor told me it was ulcerative colitis and I began taking olsalazine, which works most of the time and helps prevent relapse. That’s the gold standard for ulcerative colitis. But it’s not perfect. Every now and then I still suffer from abdominal cramps and inflammation, and cannabis helps take the edge off. And thinking about the future, if I ever have another flare up, I would want cannabis there to help me through the pain and of course working with my doc getting plenty of steroids, whatever it may be, to up the level of anti-inflammation. But for me it really helped just relieve the immediate pain right away so I could get up out off the toilet and to the doctor.
So that’s my anecdotal experience, in terms of the medical literature, which will also be in the petition so I won’t go into it too deeply. In a 2011 study, researchers published an article that found CBD reduced inflammation in the gut via the neuroimmune axis in both animal and human tissues. In just this year researchers published an article, which was a randomized, double-blind, placebo controlled parallel group study of CBD oil for ulcerative colitis and they found that CBD reduced patient’s ulcerative colitis symptoms and improved their quality of life scores. These studies demonstrate that CBD is beneficial for patients with ulcerative colitis, and these studies will be further discussed in today’s petition.
For my closing statement I would like to respectfully ask the board for the betterment of Iowans with ulcerative colitis please add it to the list of qualified conditions. Thank you.
Michael: Laurel?
Laurel: Thank you. My name’s Laurel Manning. I work at Heartland Family Service. As a prevention program director I’ve been doing prevention work since 2002. And so I thank you for allowing me to speak during the public comment time and thank you for inviting AC4C up here to speak. As a member of AC4C across the state we’ve worked together on issues like this. And I, I appreciate the duties that you are charged with as a board are large and vast, right, so thank you for your service, to that.
We are cautiously optimistic that the CBD program will help suffering Iowans. Again as we see it, before, we are for the compassionate use, we want the science and research to be there before we jump into increasing THC content and things like that. Our voice represents hundreds of thousands of Iowans, just like every other person that’s here, but often times our, the people that we represent, their voice goes unheard. And so we just want you to take that into consideration.
And everyone’s story is important. Whether it’s a story of someone whose been having seizures, or whether it’s a story of someone who has addiction, or has lost someone to addiction, and so often times our stories get aside when we’re talking with people, and it’s frustrating because our stories are just as important as everyone else’s story in this room. And the people that we represent who suffer from addiction and die, we know that the damage that THC does to developing brains is real. It’s really real science. Are the people who have smoked marijuana through college and been fine and passed it successful? Yes. But are there people that have smoked marijuana in college and dropped out and developed an addiction and died from a heroin overdose? Absolutely. And so that is your job as a board, right, is to root out all of these things and not take one perspective into consideration into another but weigh them all equally.
One of the things that I would like to recommend is that there’s a voice of prevention and treatment on the medical board. We are prevention specialists, we work tirelessly to study what’s going on in other states. 360 degree view. It’s not just from an anti-marijuana standpoint. We work and look at everything because we wanna help people who are sick. That’s our bottom line too. But also we don’t want to help, we don’t want to, risk, other people who have a propensity for addiction with THC. You know, I just think that the THC content should not, that the limit on it should not be eliminated at this point. Our program is not even up and running yet. It’s not even fully operational. And we’re already considering taking off the three percent limit? Why? Why are we doing that? Why can’t we wait and see how this goes, and see what happens once it gets up and running?
And I know that the intent is this “medical CBD” and even, people have mentioned medical cannabis, and recreational use is not (unintelligible) at least that’s what people say but every single legislator that I have talked to have always, they say, it will not lead to recreational use. This will not happen within our state. And I’m here to tell you it will. It’s happened in lots of other states. Eight already, where medical leads to recreational. This is like a snowball sitting at the top of a hill. That three percent limit is keeping that snowball at the top of the hill. Let the program get up and running, let’s see what happens with this, let’s see where the research goes before we take away that limit and push that snowball down the hill. Thank you.
Michael: Thank you. Alright. That’s going to close the public comment period. Thank you for everyone for the information and feelings you gave. We do appreciate that. Nine on the agenda are the petitions to add or remove qualifying conditions. Sarah Reisetter, deputy director for the department will lead our discussion on the petition proceedings, um plus the addition of these three conditions to the list of debilitating conditions.
(1 hour) Sarah: Thanks Michael. Um, I thought I would just start this portion just by giving you guys a quick overview of the petition process, what happens with petitions, once they’re, once you guys do something with them. You know, there are additional steps that would come next in the event that you would choose to recommend the addition of a condition. And so, um, the petition form, the petition process is laid out in our administrative rules for the program, that kind of dictates the framework in terms of what information is requested on a petition form. There is a petition form that has been developed, it’s posted on the Department’s website so it’s available to the public. Anybody can file a petition to add a condition. And so before you today, the Department has received three petitions.
The rules provide that the Board needs to take action on the petition within six months of the time that that petition was received, unless you work with the petitioner to provide for a little longer period of time. Setting you guys up for quarterly meetings means that we should have probably a couple of meetings at which you have an opportunity to consider each petition. You’ll recall we talked about the the the, and I tried to say this at your last meeting and I butchered it, and I’m going to do it again – the trigeminal neuralgia petition. That one was received in April so we will need you guys to take action on that form today. The other two were received after that and so you could defer and take the action at your November meeting if we, don’t feel like you’re ready to take action on those today.
So basically the rules call for either a recommendation to add the condition or a denial of the petition at your level here, this board’s level. If you do choose to recommend the addition of a condition, the next step is that recommendation under the statute would be forwarded to the Board of Medicine. And so then the Board of Medicine would decide whether to move forward with adding that condition, and the Board of Medicine is to do that by administrative rule. So, in the event, just for everybody to be aware, in the event that you would recommend the addition, that’s not the last step. It would go to the Board of Medicine, and if the Board of Medicine decides to add it by rule, then there would be a period of time for rulemaking. I think the minimum time to adopt a rule under the normal process is 105, 108 days, somewhere around there. So it’s a lengthy process, it’s been established, um, the statute, that’s procedure wise how this (unintelligible).
The other thing that we have done, is to protect patient confidentiality, we have redacted identifying patient information on these petitions. And so as we’ve called them up today, we’ll ask if the petitioner is in the audience and would like to address the Board related to the petition. The petitioner would have the option to not get up and identify themselves and that would be just fine.
The rules indicate that the Board can also ask petitioners to submit additional information concerning the petition. We talked about that at the April meeting related to the trigeminal neuralgia petition and you guys indicated you weren’t seeking any additional information.
The rules also say that you can solicit comments from any person on the substance of a petition, and that comments on the substance of a petition may be submitted to the board by any person, and so we heard some of those today during the public comment period as well.
Do you guys have any questions about process before moving forward? Ok. So the first petition, and I will clarify too then, um, if you decide to take action on these, we’ll need a motion, and a second, and a final vote on the board related to any action that you wish to take on any petition.
So the first petition is trigeminal neuralgia. And so I think that the petitioner is here and wishes to speak to the board now would be a good time to do that on the original petition.
Ok so with that I guess I’ll go ahead and just turn it over to you for discussion for the petition. What do you guys think?
Dr. Guy: One question I have, how is this different from chronic pain, and what are other states doing, are they identifying specific individual conditions, or are they kind of lumping it in with the chronic pain, and the gastrointestinal severe just, for input?
Dr. Other guy: I can’t directly speak to it but I’m not (unintelligible) just being a specific issue. I remember at the last board meeting, Dr. (unintelligible) did mention that someone would (unintelligible).
Dr. Guy: I haven’t seen it in other states.
Dr. Someone: I think it would fall under intractable pain as well but I think that there are (unintelligible) that are here today that are not entirely sure what that definition means. So, personally I would support adding this because I think it’s already known under the intractable pain one, but I think that if somebody thinks that they need more explicit evidence of that I would be surprised.
Dr. Lady: I agree. I think it’s, it would be, it’s under untreatable.
(Quiet murmurings of agreement)
Deputy Director Sarah Reisetter: Would you be supportive of, because it fits under intractable pain, would you be supportive of um, supporting it, the addition of this particular condition as well? A an enumerated condition for which a doctor could certify?
Dr. Lady: That would be fine with me.
Sarah Reisetter: Dr. Miller, Dr. Stoken, Dr. Schreck? Are you still with us? Any other discussion?
Dr. Schreck: One more?
Sarah Reisetter: Hi again Dr. Schreck. We’re talking about the trigeminal neuralgia.
Dr. Schreck: K. Actually I’m muted so I can hear you all well. I think you’ve seen my comments, I assume, from earlier. I could find one record of that in the literature and a, and cannabis. (Unintelligible). I do agree with the idea that untreatable pain will be called in Iowa, it’s intolerable, it’s a terrible condition to have, it’s a horrible, bad problem, to go through. And there is no solution for it. (Unintelligible). It’s not very treatable. I would think you would qualify with any condition to be prescribed powerful products based upon the untreatable pain. There’s lots of medical conditions that cause pain. But I don’t think we need to have everything under one of them.
Dr. Guy: So here’s my question for you then. Do we, need to see if this can be included under the already existing untreatable pain or is that up to the motion, how?
Sarah Reisetter: So if the board decided not to move forward with adding the condition, um, in terms of making a recommendation to add a condition on that basis, this is untreatable pain, we would detail that information to the petitioner when we would send the board’s response back to them. I can’t even say what that person’s physician would do with that information. I don’t know whether they would certify them based on the board’s denial or not. And so really, you know I think that’s, for you guys to discuss, in terms of whether you want to recommend enumerating all of these sorts of pain conditions.
Mod: I guess, is there a motion, anybody would like to set forth to kind of get the next process here from the board?
Dr. Guy: I would recommend that we would recommend to the Iowa Board of Medicine that trigeminal neuralgia be added to the qualifying conditions as we considered already covered by the – well, I’ll just stop.
Mod: Is there a second?
Dr. Lady: Second.
Mod: Ok. So we have a motion and a second. Um, so all in favor say aye and because it’s going to come down to a majority vote we’ll only, kind of pause so Jen can take votes, so say “aye” to indicate long enough so that the vote can be taken. Say aye.
“Aye.”
Mod: Ok. So we’ve got three in favor, two um, Dr. Schreck are you opposed?
Dr. Schreck: Oh. I have no objection to that motion. That’s fine.
Dr. Lady: I do have one other quick question. So if we’re saying that trigeminal neuralgia already fits under untreatable pain, then why do we have to add it as another condition? I just worry that any condition that has pain could, we’d have to, we’d have to discuss all of those different conditions, and then it already falls under, potentially untreatable pain, if the patient was, sounds like this person has already tried multiple medications without success. So I guess my question is, are we adding this as a separate condition, or are we saying it already falls under untreatable pain?
(1 hour 11 minutes) Mod: I think the motion was to add separate stand alone condition, am I correct?
Dr. Guy: Yeah. I don’t know if we can, can we say this is included in the other, is that, because I thought we could recommend, you know, things to be added, but, I mean, I don’t know how otherwise we would say that we think that this isn’t included. We could add a statement. Does that have any merit? You know? In what the statute allows us to do?
Sarah Reisetter: I’m sorry (unintelligible). Um. Well, you could just, or the motion could fail and you could just make a new one.
Mod: And on the initial motion, I heard three in favor, um, being I guess Dr. Liesvold, how did you vote?
Dr. Liesvold: I didn’t vote anything.
Mod: So, by rule the motion fails on that. Is there a motion to amend it and make it a little better qualifying motion?
Dr. Guy: My concern is that if we were add it as another qualifying condition then every condition which is painful will need it’s own addition and I think it falls well under the untreatable pain category so that would be the basis of my opposition of adding to the list of conditions, because it already falls under the list of covered conditions.
Mod?: That’s kind of where I’m coming from. I don’t know how many other conditions may come forward as a petition. I understand this condition is fairly limited, but definitely painful, and that’s my concern, that this might fall under a catch all, some kind of chronic pain? Could the definition be tweaked by the legislators? I do think so, there’s room for that. Is there any other discussion on this? Sarah?
Sarah Reisetter: Yeah. Mike. I might um, I might recommend. So it sounds like, where you guys are headed, most recently, is to deny the petition, but to send some information back to the petitioner to indicate that you, the board believes, and you’ll need to have that somebody stated as a motion, but the board believes this condition qualifies under the untreatable pain category that’s already approved as a debilitating medical condition. The thing that I would ask moving forward is on the motions, is when you guys vote, if we could do a roll call vote.
Mod: Ok.
Sarah Reisetter: And just go down the row. I think that would just be really helpful for the record. So I think where we stand, now is that there’s a motion that failed and so we would be looking for another motion on this particular petition.
Dr. Liesvold: So if I could make a motion on the trigeminal neuralgia, it would be classified under the untreatable pain condition, identified as a separate condition, and to deny the petition.
Dr. Guy: Second.
Mod: So we have a motion and a second any further discussion before we do a roll call vote? So, Dr. Cheney? In favor or against?
Dr. Cheney: Favor.
Captain Mike: Ok. Dr. Liesvold?
Dr. Liesvold: In favor.
Captain Mike: Ok. Myself. Ok.
Dr. Lady: In favor.
Dr. Another Lady: Thank you.
Captain Mike: Dr. Miller?
Dr. Miller: In favor.
Captain Mike: Dr. Richards is absent. Dr. Schreck are you in favor or against.
Dr. Schreck: I’m in favor.
Captain Mike: Ok. Dr. Stoken?
Dr. Stoken: In favor.
Captain Mike: Dr. Zadeh is gone. Myself I am in favor of including that one. Is there anything else we need to be doing to that one?
(1 hour fifteen minutes) Sarah Reisetter: Not to that one, nope. So the next petition on the agenda is for the addition of PTSD and bipolar disorder. Is our petitioner here in the audience and would you like to make comments to the board if you are? Ok. Seeing that I think it’s time to open it up to the board for discussion on the PTSD and bipolar disorder petition. As a reminder, you have six months to make your, determination about what you want to do on a petition under your rules. So theoretically this could be deferred to November if there is additional information that you would like the Department to gather or if there’s additional research you guys would like to do. We’re happy to help with any of that, so at this point in time I’ll turn it over to you for discussion.
Dr. Schreck: I can’t, this is actually, it’s (unintelligible) to add two separate conditions. I think we should discuss it and think about it separately. (Unintelligible)
Dr. Lady: And my question was, is this person petitioning to add both of them because it just says add PTSD on the second page even though it says PTSD and bipolar disorder on the first page. But then they didn’t include any information on bipolar disorder within their petition, just PTSD.
Sarah Reisetter: So I think that you guys, I mean it says PTSD and bipolar disorder on the cover page. I think if there is one condition that you feel like, do you want to move forward with today, there’s another condition that you’d like to request more information about. You know you could certainly do that. I agree with Dr. Schreck’s recommendation to kind of take them in turn and to vote on each of those conditions separately.
Dr. Guy: I would agree with Dr. Schreck’s recommendation as well. But unfortunately that is not how it is proposed. So. I don’t know that we can split the proposal as we see fit, or if we prefer to table it, seek clarification and then readdress at a later time.
Captain Mike: Any other discussion or input from the board?
Dr. Schreck: We don’t need a petition to add a condition. (unintelligible)
Dr. Lady: I would certainly agree. I mean they’re clearly two separate conditions.
Captain Mike: Do we want to do this, or do we wanna kick it back just for clarification, I’m just – are we setting a precedent here, that some of the information on the submitted petitions can be different, um, then what’s on the cover page, and then, is that true that we can decide conditions without a petition or a little inaccuracy on the document?
Sarah Reisetter: Um. I think that that’s right and I think you guys have the authority to recommend adding or removing conditions. Um, if I could look at that statute here really quickly. Yeah, so in Section 124E.5, subsection 3, where it outlines the duties of this board, it says um, the duties of the board shall include the following: accepting and reviewing petitions to add medical conditions, medical treatments or debilitating diseases to the list of debilitating medical conditions for which the medical use of cannabidiol would be medically beneficial under this chapter. So that kind of outlines the petition part. And then a separate paragraph there, paragraph “b” says, making recommendations relating to the removal or addition of debilitating medical conditions to the list of allowable debilitating medical conditions for which the medical use of cannabidiol under this chapter would be medically beneficial.
So those two duties are set forth, and kind of exclusively in the statute, so I do think that we would have the ability to add them without receiving the petition. We would have the ability to make those recommendations.
Captain Mike: Ok. Any further discussion?
Dr. Liesvold: Well, I’d be in favor of giving us a little time to look at some of the studies. Specifically for PTSD so we (unintelligible).
Dr. Stoken: You know I think the dilemma I have as a physician being on this board is that there just isn’t a lot of scientific medical evidence for some of these conditions. And I agree with Wendy, you know, if we approach it as compassionate care, I’m going to be doing a much better job at that than looking at controlled studies with some of these conditions, because there just isn’t a lot out there, particularly in psychiatry with bipolar disorder in particular, and also with the literature with PTSD, there just isn’t a lot out there. Certainly we could go on with anecdotal evidence and listen to what our patients tell us, I have many many many patients who tell me that marijuana is the only thing that has worked for anxiety, or depression, or insomnia, or PTSD or whatever. But it’s pretty much all anecdotal information. But certainly, I would like to consider myself to be a compassionate physician, and I certainly recognize that, you know, marijuana might be helpful in certain situations, but there just isn’t a lot of scientific literature out there to show that there is evidence for treating these conditions.
Dr. Zadeh?: There’s a review of twelve studies that was just published. They reviewed these twelve studies that have been done on, using cannabis for mood, anxiety, depression, PTSD, panic disorder, bipolar. And, well it helped them. Well they found that it acutely helped them but long term it didn’t help as much, so. You know I agree with being the compassionate care, so, I would be interested in taking a look at these studies, and getting a more educated answer.
Captain Mike: Any further discussion?
Dr. Guy: As I would understand it, we would need a motion to separate these two conditions, is that correct?
Sarah Reisetter: Yeah, well, um, I think that you can just consider, I don’t think you need a motion to consider them separately. I think that both, we just need a motion to say how you want to treat each condition. So, if you want to defer to a future meeting, if you want, or if you choose to make a recommendation today or a denial today, on each of the conditions, that would be helpful.
Dr. Guy: I think the cleanest way would be to separate the conditions and then I guess work on both, eventually at some point, on either condition –
Sarah Reisetter: Yes.
Dr. Guy: — otherwise, as this petition is written, it is for both conditions. So.
Sarah Reisetter: Correct. Yeah, so I don’t think we need a motion to consider them separately I just think, in your motion, just, refer to one of them at a time.
Dr. Guy: So I guess what I’m looking for is a motion to take a vote on the first condition today, or, a motion to delay it?
Sarah Reisetter: Yeah. I would say that the motion, you have three options. One would be a motion to deny the petition, to add the condition. The next would be a motion to make a recommendation to add the condition, and the third would be a motion to defer a decision on the condition until the November meeting.
Captain Mike: So hearing all that, is there any further discussion? Otherwise I’ll entertain the motion.
Dr. Lady: I would make a motion to be firm on this particular petition (unintelligible).
Sarah Reisetter: Excuse me, for both conditions?
Dr. Lady: For both conditions.
Dr. Guy: I second.
Captain Mike: So we have a motion and a second. We’ll do the roll call vote again. Dr. Cheney are you in favor or against the motion?
Dr. Cheney: Uh, in favor.
Captain Mike: Dr. Liesvold?
Dr. Liesvold: In favor.
Captain Mike: Dr. Miller?
Dr. Miller: In favor.
Captain Mike: Dr. Schreck?
Dr. Schreck: In favor.
Captain Mike: Dr. Stoken?
Dr. Stoken: In favor.
Captain Mike: And myself in favor.
Sarah Reisetter: Ok so, hearing that, is there any information that you guys would like us to request from the petitioner that, I went over your rules earlier, you can solicit comments on the petition from anybody that you want, so, what can the Department do to assist you in preparing for your November meeting in terms of gathering information and making contacts?
Dr. Guy: So, this is at the opposite end of where I practice, but, I believe that the VA is involved in some ongoing studies about this and if there’s any preliminary data from some of those ongoing studies with PTSD would be useful. I don’t know if any of you know about those?
Dr. Lady: I do know that there are ongoing studies, I’m not privy to the results of course.
Audience member: On that subject –
Captain Mike: I can’t allow any public input on this. I’m sorry. Is there any further discussion now then?
Dr. Guy: I think the one question I had was, was this a comorbid thing occurring in the one patient? Or was this the different multiple diagnoses? I didn’t know if this was a personal request, or just kind of a shotgun approach to include different disorders.
Captain Mike: Any other questions or input you’d like the staff to research?
Dr. Guy: Is it helpful for you to know what other states have approved conditions? Or do you not care?
Captain Mike: Sure.
Dr. Guy: I think that’s always helpful.
Dr. Lady: I would be interested in just reviewing, it was just published yesterday, I mean July 30th, (unintelligible).
Dr. Guy: What they took into account.
Dr. Lady: And I sense that’s (unintelligible).
Captain Mike: For me, to, is there kind of like an ending, recognized opinion on the amount of THC, I mean obviously that’s kind of the elephant in the room. Right now we’re talking about a three percent cap, but let’s say we approve these two things going forward, and then there’s a motion to let the THC content go wide open. I think what I’ve seen in the studies, the higher the THC, the more there might be negative issues or adverse side effects, so what would happen if that happens and all of a sudden the laws change? It’s kind of hard to put the genie back in the bottle and, what happens from there?
Dr. Guy: I think we could decide to remove a condition from the list of coverages.
Sarah Reisetter: You could do that yeah. It’s addition or removal.
Captain Mike: Ok.
Sarah Reisetter: In terms of making a recommendation.
Captain Mike: Is there any other input or discussion on that one?
Dr. Lady: Randy, for the states that have approved PTSD if they have any data on if it’s been helpful, particularly for PTSD, have there been any adverse reactions such as increase in psychosis and that sort of helpful to know as well.
Dr. Guy: Just for my input, can any medical doctor diagnose somebody with PTSD or is there a certain test or industry approved standard?
Dr. Lady: I would like to think it’s the intelligence of a psychiatrist that can only diagnose that, but certainly those conditions can be diagnosed by a family medicine practitioner.
Sarah Reisetter: Ok. So is there anything else that we can pull together for you? We will work on doing that here so we can get it to you in the amount of time so you will have the opportunity to take a look at it by the November meeting, and we’ll split these up and put them both on the agenda for that, for that meeting. Ok.
So the next petition on your list today is ulcerative colitis. So is the petitioner in the room and wish to make? Ok.
Petitioner: Would it be like a comment before or can I just be available for questions?
1 hour 30 minute mark
Sarah Reisetter: You can certainly be available for questions if the board has them as they discuss that that would be fine. Did you have a comment before as well? No? Ok. Alright. So with that I’ll go ahead and turn it over to you for discussion.
Captain Mike: Did you wanna make the comment first or? Ok. To the board is there any discussion on this condition?
Dr. Guy: I would say that this was almost an oversight, that this was left off to begin with with a very close condition being included from the get go so.
Dr. Miller: You know, in my take on this I’m not really sure how the conditions are on, got on, and why certain ones didn’t, so you know I think we’re probably adding conditions now, we’re probably going through a more rigorous process than the ones that are already on that have been approved. And I honestly haven’t done literature reviews, say on Crohn’s and some of the others, so, you know, I think for us to be giving some medical advice and going through a more rigorous procedure, it’s not really fair for the people who are petitioning new conditions to go through a more rigorous process compared to people who, you know, already have approved conditions that didn’t go through a medical advisory board.
Dr. Guy: And for the other
Dr. Schreck: I’d agree with that. We’re supposed to have a gastroenterologist on our board but we’ve been (unintelligible) which is unfortunate because they can help at least give guidance on what the literature says. But we can probably obtain that opinion and information out by the board. Are there gastroenterologists available to talk and visit and be questioned?
Dr. Guy: I kind of agree with Dr. Miller, I think that the fact that they are including crohn’s and not ulcerative colitis was probably an oversight in the middle of the night, because they were forming this legislation. No offense.
Unknown: It was a ridiculous process.
Carl Olsen: 6 am
Dr. Schreck: (Unintelligible.) These people are in a tough position because opiates…(unintelligible)…we talked about pain. Untreatable or intractable pain. (Unintelligible).
Dr. Zadeh?: I would agree with that. I think crohn’s disease and ulcerative colitis are very similar so if we are going to have crohn’s disease as a listed and approved condition and then deny ulcerative colitis it just doesn’t make sense to do that.
Captain Mike: And just for clarification, Randy’s served our department for a long good –The board did not decide any of those prior medical conditions. That was the state legislature –
Sarah Reisetter: Right.
Captain Mike: — that did those, so this is actually the board’s first go around with this, so bear with us, we’re trying to do this for the first time. But all of the conditions that are out there were already picked. My next question is, so besides crohn’s and ulcerative colitis, is there anything similar, (unintelligible) chronic pain thing, is there something where the bad gastrointestinal issues that we could kind of make a one size fits all to include those or are these kind of the major ones that you folks have heard of?
Dr. Liesveld: I mean I’m a psychiatrist but I’m not aware of any other major GI conditions besides crohn’s or ulcerative colitis.
Dr. Guy: Sir, I believe I’m correct in saying they all fall under the category of inflammatory bowel diseases.
Dr. Zadeh?: Well, appropriate, instead of crohn’s, inflammatory bowel disease.
Sarah Reisetter: So, because crohn’s is listed in the statute, that would certainly be something, I’m jotting a little list down here, because of course at your November meeting we’re going to talk about your report to the Legislature, and recommendations that you wanna make in that report again. And so that this, you know, we can’t do anything about that that crohn’s is listed in the statute but we can certainly make a recommendation that they include irritable bowel syndrome.
Captain Mike: Is there any further discussion from the board members? Ok so hearing this, again, it’s the same three options as before correct?
Sarah Reisetter: Correct.
Captain Mike: Take the vote today, um, delay it, or um, deny it.
Sarah Reisetter: Deny it.
Captain Mike: So hearing all that if there’s no further discussion, is there a motion?
Dr. Guy: I move we add ulcerative colitis.
Dr. Schreck: I would second.
Captain Mike: We’ll give that to you, Dr. Schreck. (Laughter) Thank you for staying on the phone. So we have a motion on the second, any further discussion on this before I take a roll call vote? Dr. Cheney, favor or against?
Dr. Cheney: Favor.
Captain Mike: Dr. Liesveld?
Dr. Liesveld: I’m in favor.
Captain Mike: Dr. Miller?
Dr. Miller: In favor.
Captain Mike: Dr. Schreck?
Dr. Schreck: Favor.
Captain Mike: Dr. Stoken?
Dr. Stoken: In favor.
Captain Mike: And myself. I’m in favor. Is there anything?
Sarah Reisetter: Ok. So the next steps on that will be we will draft some correspondence to reflect your decision here today and we’ll get that sent down to the Board of Medicine. I believe their next regularly scheduled meeting will be in September so that will be the time in which it will be on the agenda at the Board of Medicine, um, if you’re interested.
Captain Mike: Thank you.
Dr. Guy: I would just say as adding it on last time to represent the Board of Medicine doesn’t take care of all the things you would do so it might be beneficial for the petitioner to comment don’t you think Brandon because they really are like, dealing with this for the first time too so I think it’s always good for them to hear.
Captain Mike: Ok. Thank you. Next item is department update with Sarah again, the Deputy Director, um, to explain the activities and the work in the Office of Medical (unintelligible).
Sarah Reisetter: Yeah. Actually I’m going to go ahead and defer my time to Owen Parker. So, I introduced Owen at the May meeting to you guys. Owen’s been working with us full time since about that May time frame.
Owen: I believe our last meeting was the first week.
Sarah Reisetter: Yeah. That’s right. So we’re gonna kind of let him give you an update today and then if I have anything to add when he’s done, I will, I will give you that but as soon as he gets his presentation up here.
Owen: I just want to thank the board for doing a bunch of work with us this far and for all of the public for being here. As I mentioned, last week, or the last time we were here was my first week of working. We certainly have a lot still to do. (Unintelligible) and construction of the program. I’ve only been here a few months, we definitely made some good strides. And um, this is mostly um, I’ll definitely keep it uh, generally high level here. A lot of the information is meant to be for the medical board.
So this is just going to be a high level overview of some of what we’ve been charged with and (unintelligible) with from the start. One of my first tasks was designing an inspection protocol, (unintelligible) an overview of the protocols and timelines for how we were going to do this. This is, there’s not a lot of an issue with standards, specifically for these protocols but we worked with our neighbors (unintelligible), each program is similar to ourselves. Including, we looked at Pennsylvania, Massachusetts, Oregon, Minnesota. And we feel like we designed a program because it resolved our compliance rules, essentially it’s straight from the statute. And it’s also pretty straightforward with licensees, all of them have those down, we haven’t had any complaints yet.
The next thing, we applied acceptance criteria. This is also definitely a challenge. It requires collaboration between all of the parties including our manufacturer. (1 hour 39 minutes) We are posting inpatient here. Obviously public safety is at the forefront of, you know, everything that we’re doing here. It’s hopefully also not an unnecessary cost burden to our licensees. We’ve done, you know, quite a bit of even amending, some of our rules do change, stages of which we’re gonna be testing.
The third thing, going up there, and I’ll also speak a little bit more in depthly with some of these things with future slides. But our website comes to a little bit of a private, faster project we’re a little bit behind on. As we’ve heard today, education is a very important piece to this. We’re in the process of creating a temporary site, editing what we have now, there’s obviously processing that’s going to be updated, information that needs to be better structured. And then behind the scenes we’re working with an internal consultant group to build a similar bus site for, to be live in the next couple of months or before the go live. But we also are, a second licensing manufacturer, we have four applications for that, and that’s something I’ll go a little deeper in on in the next slide.
Inspection of our manufacturer, MedPharm. I’ll also go deeper into this. MedPharm having, you know, now that he’s experiencing very similar industries, is definitely a sophistication of facilities. We inspected security and cultivation and they completed all aspects of their check lists.
Uh, dispensary inspections. This will obviously will not be ready until the fall. All of our licensees are still in the process of building out, and then product to market is obviously how they’re (unintelligible). A lot of programs don’t start on time, projects get delayed, there’s a lot of variables that go into that. But in general, we feel (unintelligible).
There’s some, some recent accomplishments. We ended up selecting Iowa Relief as our second manufacturer. They’re a organization that has multi-state work grade experience. They will be in Cedar Rapids Iowa and required to be operational on September or uh July 1st of next year. You know what their experience brings to the table is that they already have systems that work for them. They have already tried a lot of different things. They have experience with remaining compliant, they’re also proposing some complementary products to MedPharm which will just increase the spectrum that’s available to our patients.
And as mentioned –
Dr. Lady: I’m sorry. But they will have a manufacturer right here in Iowa?
Owen: Yes. They’re, um, MedPharm, you know retooled an existing facility. Iowa Relief will be building a stand-alone facility. It’s a mimic of what they’ve built in other states, so again, they don’t need to, they’re not recreating the wheel, it’s something they’ve already done.
Dr. Guy: They’re going to be in Cedar Rapids?
Owen: Yes.
Dr. Guy 2: Will we be getting a different presentation by then?
Owen: Um, we did invite them, um, but they, you know they have a lot of moving parts and they’re just getting going. We just licensed them on July 1st. He said –
Dr. Guy 2: In the future.
Owen: Yeah. He said, there will be, he mentioned there will be a presentation at the next meeting. Or at least there’s one to call in to update (unintelligible).
Uh, inspection of MedPharm. Again we’re doing kind of an operational readiness type of inspection protocol. Uh, my experience in a lot of states, the things that delay programs are when you have to wait for the end of operations to begin inspection. Considering how comprehensive those things are, if there’s even one thing that’s not checked off, you have to wait, you know, you have to design a protocol, come back, inspectors can, you know, that can risk delaying projects altogether, months. Sometimes even longer. But again, I think MedPharm’s experience directly now in this industry in terms of, you know, extracting molecules from plants, has definitely helped them from this.
And again, the same thing with protocols and testing. Again we’ve had quite a bit of back and forth on this. In terms of industry standard it’s something that’s incredibly variable across the space. We have, you know, collaborated more and more with all of the other stake holders involved, and we will have that completed shortly. And, you know, how we are going to be testing is something I’m going to be sharing with you all as well. But in general, it will be public on the website.
Some of our upcoming plans here. Again the big thing is the website. We understand how important the education of it is, but first, you know, putting first things first, developing our compliance and infrastructure has been the most important. And additionally we feel that, you know, again, as I mentioned earlier, we are not the physicians. I think in terms of education, that’s something we would like to collaborate with you, and in general, you know we, we were doing some speaking throughout the fall, and we were kind of relying on Q & A sessions, um, to get feedback from physicians on what they’re looking to hear and what information they wanna make public so that they would feel most comfortable in certifying, certifying these conditions.
They um, in general, again, what we’re generating into is real patients and providers. And the big thing coming in the fall as well is going to be inspection of our dispensary licensees. And uh, adjoins with compliance and rules. Public safety is, you know what I mean, priority, and then, you know, compliance of our licensees, and then starting the program on time. And uh, Doug will speak more to this after I’m finished. But our seed to sale system will be, you know, it will be relaying information at pivotal times that we’re looking to keep track of from our licensees. And uh, we also are, we have, we do weekly stand ups, and we are in constant communication with our licensees, and I think that just gives us the best chance to insure overall compliance. And I think, you know I just, again, when we keep it fairly high level we’ll have even more information for you come November, but these are just some of the things we’ve been working on within our department. And I’m happy to, you know, answer any questions, from an operational standpoint that I’m qualified to answer. It’s really where we’re at.
Captain Mike: Ok. Any questions for Owen? Sarah? Ok. Thanks so much. Moving on to the next item. IT tracking system update. Doug Cretsinger is also working on the IT tracking system for the department is here today to provide an update on the seed to sale system?
Doug Cretsinger: Thank you. Good afternoon ladies and gentlemen. Thank you for having me. My name is Doug Cretsinger. I am the project manager for the Iowa secure seed to sale tracking system. By way of background, I have over 20 years of experience with large IT system implementations and I’m very happy to be apart of this program. Over the last five years I’ve also served as a Chief Information Officer here in the Des Moines area so I am very pleased to bring that experience to this project and this outstanding group of project team members. Many of them with us today in the room. Randy is our project sponsor, he does a fantastic job of supporting us on the project. Sarah is our executive sponsor. I escalate issues to both of them and they’ve been very helpful in resolving those issues as they come up. And Owen being the newest addition has been extremely helpful in understanding the industry background that we need to comply with.
So that’s the background. We’ll get into, how does this thing work? To the right. Here we go. So I just talked about the team. I’m on a small system team with a group, BioMorris out of Oregon, who have came out of pharmacy industry doing tracking pharmaceutical products to from product creation to distribution so they have a long history of developing those systems, and they then in the medical cannabis system development, in the industry, coming out of Oregon. So they’re a very talented but small group of folks working diligently to create this system. As Owen said, we are working very closely with MedPharm as our manufacturer in the state hygienic lab and all of our dispensaries as Owen said. We have weekly meetings with both MedPharm and dispensaries to ensure that we are on track and staying on track.
Overall we’re on very good shape. Manufacturing is on track for 12/1. Go live, the dispensary is on track for 12/1. All of them are in various states of construction at this point. All of them are saying that by October they’ll have stores built in the five locations that we’ve established for Iowa. The last time I think Randy gave the update the dispensary system had not been fully tested and approved. It is now, and we got a jump start on registration system, which is how patients and caregivers get their cards authorized through the Department of Public Health. We’re pretty proud of the changes we’re gonna be making here. This is going to be a fully online system, with the ability to pay with debit card, credit card, or e-check. Any of those payment types will be accepted by us and it will allow us to review all of those applications online at the Department of Public Health to go through the approval process. The biggest problem we have today is incomplete applications. Well any of you that do online applications or online work at all know that the system will call out anything that you’re leaving off before you hit the submit button. It will say here’s a red item, you need to complete this in order to move on through the process. So this will systematically ensure that the applications are complete. And then when you submit you know you’re good to go and you know you don’t have an incomplete application. So that’s the state of the union um, we’re ahead of schedule on registration, we’re actually going live at the end of this month with that new system. We’ve revised the health care practitioner form, the patient application and the caregiver application and those will all be available online at the end of this month.
So the last thing I was going to talk about is just, um, we control all of the transfers in the state of Iowa, from the manufacturer to the dispensaries, to the lab, and back, and we’ve created the first of it’s kind mobile transfer app for the drivers at MedPharm. So, the drivers leaving the factory at MedPharm will have the ability um, to deliver and pickup products and returns from the dispensaries. Some states the dispensaries actually have to destroy it on site and they have to call a sheriff out to throw gasoline on the product and incinerate it there in front of them. It’s that ludicrous. We don’t have any of that. All of the destruction will happen at MedPharm. The dispensaries are quite happy about that that they don’t have to involved in disposal. So all of the deliveries and pickups to the dispensaries and the labs are tracked throughout their life cycle and what this app does is allows the driver to say, I’m on my way to um, to one of the dispensaries. Are you ready to receive this transport. Here’s my ETA, it’s run off of Google Maps, uh so any of you that use Google Maps or any other mapping system know that it gives you an ETA, um, we also have the ability to log all stops. So as the driver stops for gasoline, or restroom, or food, they just hit the stop button, and when they start up again they hit the start button. And what that allows us to do, using Google Maps again, is know if there’s an unusual duration for this trip. So if you’re expecting a two hour trip and it’s a three hour trip, Google Maps will say well there was construction, it did pick that up on the map, and this is not an unusual trip even though it took three hours even when we thought it might take two hours. It sets up multiple legs and transfer itineraries for the drivers so they can, if they’re making a multiple trip to several dispensaries it helps them to do that. And it racks that inventory again from MedPharm to the dispensary and it actually in the background makes inventory adjustments. So we know at all times in the state of Iowa where is that product. Is it in the dispensary? Is it in the manufacturer? Or is it in the truck between those? Or is it in the lab? Any of those places.
Um, so we track all of that inventory shipped and received. We make all of those adjustments in the background in our system, and we handle all returns and make those inventory adjustments as well. And we would be able to track all of that and recall all of the product that has been delivered to the dispensaries and is in their inventory and any sales that have gone to the patients or caregivers we would know that those sales have occurred as well within our system. So we can track the title “seed to sale tracking system” is exactly what we do, all the way from plant, through manufacturer through delivery through consumption by patients and caregivers and we can track that front to back just as they do in the pharmaceutical industry. Any questions? Thank you. (1 hour 53 minutes)
Captain Mike: Thank you. Next up, uh Lucas? Are you ready to go? Ok. Up next we have Lucas Nelson the general manager of MedPharm Iowa is here to provide us with an update. Welcome Lucas.
Lucas Nelson: Thank you. Alright, well thank you all for the time today. Just got a couple slides to run through then I’ll be taking you through several different things here and then obviously of course I’ll be open for any questions that you guys may have. Uh, wanted to give you an update on the building. Also our employees, kind of where we stand right now as far as hiring. Give you a little update on production, and some product, and then I wanted to touch just briefly on some of the education initiatives we’ve taken on. Obviously you’ve heard us say multiple times that we see ourselves as more than just a manufacturer, so let me touch on that just to give you all kind of a summary about what we’ve been hearing.
So building update first. As you may remember from our last meeting, we’ve done this in three phases. So phase one was the office and cultivation area, again that was so important to make sure that cultivation area was up and running so we could start our plants on time and give us enough time to make sure we could have the plants grown up and then actually hitting the market with product by December 1st. This phase is entirely complete. I think as we were talked last time, in May, we were about a month away from phase two which is the rest of our cultivation area, so veg and flower. Where our plants will spend most of their life. And then all of the rooms that were sort of pre-extraction. That includes the room where we weigh the material after it’s harvested, that includes the rooms where we actually hang and dry the plants, and then finally a room where we will do decarboxylation, and some of the grinding before it goes into extraction. (1 hour 55 minutes)
So this date we picked in our application as June 1st to hit for as far as completion and certificate of occupancy, we actually nailed that exact date, which was an absolute, amazing job by our team and by Newman construction who have been performing our work. So, we’re completely done with phase two.
And then phase three is coming along quite nicely. This is the rest of the building. So this is the extraction, all of the post extraction where we’ll formulate, our quality control lab is in there as well, and then a couple other miscellaneous rooms where products will actually be packaged, and then made available for shipping.
So I did wanna highlight just a few photos real quick of those and you can see it turned out a little darker than I would have liked. But this right here is our QCQA lab. So obviously our chemist will spend an incredible amount of time here. They insure that we know exactly what is in our products, whether or not they’re going to test positive for any sort of contaminants, anywhere from pesticides, which we’re not using in our production so it shouldn’t be an issue, um, up to metals and those sorts of things. So the goal here is anything that we send to the state lab for testing we already know what the results are going to be.
And you can see behind where that worker is standing. That’s actually the formulation lab so as things progress from here and once they’ve passed our internal quality control, there’s some controls that they’ll have to pass from the state lab of course, but we’ll actually formulate our final products within that room. And for those of you who they remember, I know it’s been several months, but this is actually a hallway that’s connecting the lab side of the facility to the grow side. So that door there at the end is actually where you enter the cultivation area. As soon as construction is complete there will actually be a door to the lab side. So just like most of Kemin’s buildings where raw materials enter one side and the manufacturing process happens and then the final products are delivered out the other end, very very similar setup here.
So employment update. We are nearly fully staffed. We have one cultivator right now, we’re looking to bring on another, and we’ll also likely be looking to hire a little bit of part-time labor help. But our current cultivator does have a horticulture degree from Iowa State, and so very very well equipped, he’s run a different medical industry in Arizona before, so very very happy to have him on board. Our extraction staff is now fully built out. We have a senior chemist with a PhD in chemistry, and an associate chemist as well, both with Iowa ties too.
Operations staff, we’re hiring one operations coordinator as the position we’ve titled it. He will work very closely very closely with me on kind of everything that touches this operation. That gentleman will be joining us next week actually. So just about fully staffed for the manufacturing side right now at least. There are certainly more to come as hopefully we are able to expand, of course. Um, transportation staff is probably the last thing we need to do as you all may remember from the law, MedPharm is required to have two employees who will transport material to dispensaries, back from the dispensaries to the lab, we’ll be hiring those folks here a little bit later in the year.
And then finally, this isn’t quite manufacturing but we are close to hiring a dispensary general manager who will kind of oversee that entire side of the operation. So that’s progressing nicely and will hopefully eliminate those duties from the team here.
So, thought I’d give you a little update on production for now. So we did perform our first mini harvest that we’ve called it. These were a couple extra mother plants that we decided to go ahead and flower out. So those plants were grown through the entire life cycle. They were then taken down and harvested. We weighed them. They’ve just completed the drying phase. In fact when Owen and Doug were out they were able to see the plants hanging in our curing room because they were such a small number of them it was great that we were able to experiment with them a little bit with exactly what size of plants we’ll want as far as the drying is concerned. So, we hung the whole plant, and we cut some others down into pieces and we wanted to hang those as well to kind of experiment time in there. So we have that as well. Most of that material will eventually be extracted, mostly for testing for our team so they know kind of what to expect from the extraction machines. We obviously have a good idea but nothing like doing it in your actual building.
So right now we’re in the middle of growing our first production run. Those plants are mostly in the early flower stage right now. They’ve still got several weeks before they’ll be complete but they’ll be coming along quite nicely. And we’re looking forward to seeing exactly the yield we’ll get. I think it’s going to be a little bit better than we expected which ultimately hopefully means a little bit more product available of course.
Future schedule. We’re basically kind of running these in a couple rooms concurrently but there is a little bit of a break in there to make sure we’re cleaning the rooms and that sort of thing. But we do have several more harvests scheduled for the next several months here so I think we will have adequate product and without a doubt as soon as this market opens in December, and we’ll obviously be ready to continue to address those needs as the market hopefully expands.
(2 hours zero minutes)
But let me give you a little bit more of an update on our product. After working with the Department to make sure we were approved we recently announced our product line. They’re going to be branded under the Aliviar line. So there will actually be various formulations, we mentioned this, you all have heard this before, various formulations for our products, that will contain ratios of CBD and THC. Underneath the Aliviar brand will be a descriptor that we’re using, Calm, Comfort and Harmony, those are various formulations. And really hopefully we’ll make it easier on patients, on providers, on the folks that are working in the dispensaries to quickly identify ok, Calm is associated with a little bit higher THC, the Harmony is the balanced ratio, and then Comfort would be the other side, a little bit more CBD than THC. So all of those are progressing nicely, we’ve been working closely with Owen and Doug as well on getting all of the labels finalized. Hopefully we will be able to have that done here in the next couple weeks. Trying to make sure we make sure that all of the information that is necessary is actually included right there on the label or on the packaging and depending on how that all shakes out of course we want to make sure we are educating our patients so that they don’t encounter any sort of issues with law enforcement or with any of the other physicians they may be speaking with. Certainly a big concern of ours and I think this entire industry.
So this is the last point I wanted to touch on a little bit. As I mentioned we see ourselves as much more than a manufacturer. Certainly concerned with education. Um, let’s start with some of the community education forums we’ve been hosting. So these are forums where we invite the general public, anyone can come. We give a brief little discussion just to kind of highlight some of the aspects of the program that a lot of folks may not know enough about, and then open the floor up for questions, for discussion about this entire program.
But we highlight and don’t necessarily have to debate anything, you know I’m happy to clarify any more. But did want to highlight a couple of things we heard the most. Physicians not willing to certify conditions. We’ve gotten all sorts of range of, they don’t know how the program works, or they’re unsure about it, to, there’s not evidence, to I just thought that it was important to point out that there’s still a lot of patients very very concerned about if I do have a qualifying condition what should I do? We’ve got some, some certainly some ideas as far as getting outside groups in to speak to physicians across the state. As you all I think heard before, some of the state’s do require sort of a CME course for physicians before they’re allowed to prescribe, or, I shouldn’t say prescribe, before they’re allowed to recommend cannabis. And we’ve talked to some of those groups, and they’re certainly willing to come in and speak to physicians across the state. And so to the extent that any of you may know folks who would be interested in that, or your own clinics, we would certainly be happy to connect you with that group or others that are doing these education seminars. Again, what we’ve told these patients, what we’ve told physicians, what we’ve told some of you in our individual meetings, is that, what our biggest goal, is making sure that everyone is on an even playing field as far as understanding how the program works, what the physician’s role are, and what evidence is out there. We’re not advocating our position, obviously we are fairly biased and we think this is certainly beneficial for patients, but we think it’s more important that everyone across the state kind of is brought to the same level of understanding again to how the program works, and what evidence may be out there and then those decisions are obviously left to the physicians and the individual patients.
Again just to highlight something that we’ve heard, inhaled forms is certainly a concern for a lot of our patients that do have breakthrough pain. Dr. Smith mentioned earlier that that is something to look at and of course we’ve been hearing that from folks that are attending education forums.
We’ve done a lot of outreach to as many physicians as we can possibly reach as well. We think this is another big important part of this entire program. And if we’re going to make this thing successful in this state, obviously we have to have physician input. I’ll just kind of summarize it, some of the highlights of where the impediments have been. You kind of all heard it today. Whether or not there is evidence, and (2 hours 5 minutes) how good that evidence is is certainly a concern we hear a lot. Again confusion about the role that physicians have in this program, and then the liability questions which Heather Adams spoke to earlier. Again something we’re happy to connect any clinic, any doctor, any group with other providers who have done this before in other states or to other educational resources. Again, we want to be a partner in bringing success to this program, and so anything we can do to help we are certainly happy to do so.
And again, just to kind of highlight this for you, some of the members of the medical community, uh, we’ve heard some issues about wanting to meet with us, or wanting to meet in general to discuss this program, so if there’s anything that you all can do in your role as a physician in your various clinics and offices, we’re happy to help you in any way shape or form that you need. Again, very very concerned with making sure that everyone understands how this program works and want to serve as a resource and a partner, for all of you, for all of the physicians and for all the patients across this state. So with that I’m happy to answer any further questions. Thank you all for the time.
Captain Mike: Any questions from the board –
Dr. Schreck: This is Dr. Schreck. Can you hear me?
Lucas Nelson: Yes! I can Dr. Schreck.
Dr. Schreck: First of all, don’t be offended. It’s hard as a doctor (unintelligible) Just keep trying. Number two, again, we spoke about this before. I don’t think the list of products, I don’t think it’s just CBD oil.
Lucas Nelson: Well, there is nothing that there, there is nothing that does not have a trace of THC. That is true. One of our product ratios will be very very high in CBD. We’re looking at a formulation that would be anywhere between about 1,000 to 1,500 milligrams of CBD within the total package. And then within that same package there would be under 100 milligrams total of THC. A lot of the research that went into our product formulation decisions was based on that little bit of THC activating some of that CBD, and it’s certainly not a technical term, I can have a couple members of my team who are in the room speak to that a little bit more if you’d like, who have dove into that research, but that obviously gets beyond my skillset quickly. But no, so we will have one that is quite high, that would be the one that we recommend to epileptic patients or others who are looking for that very high dose of CBD. Within each of our products we’ll actually have dosing instructions, and the way we recommend dosing and titrating this product particularly delivers less than – I shouldn’t have done this off the top of my head – I think about a milligram or less of THC, so it will be very very minimal within each dose. Obviously for some of those patients they’ll need to start at a bit higher level and will receive a little bit more THC, but the basis of this product is to serve those with epilepsy or other conditions that strictly need CBD or, for patients who just simply do not want THC at all.
Rebecca Nelson: Yeah. And Dr. Schreck, this is Rebecca, uh, the products where CBD are mimicked off some of the products that we see in other states, so our pediatric epileptic families for example have used Charlotte’s Web, Haleigh’s Hope, and our ratios almost exactly mimic those Charlotte’s Web –
Lucas Nelson: A little higher actually.
Rebecca Nelson: Yes, ratios. So our, is about, I don’t know, 1:20, 1:30 THC to CBD and that is exactly what the Charlotte’s Web ratio as well.
Lucas Nelson: And I’ll say, this is certainly anecdotal, but a couple similar products are out on the market in a couple of other states and have sold very very well. And the patients have reported pretty good outcomes from those. So, again, anecdotal, not saying that that necessarily guarantees anything here but we feel very confident about that particular formulation.
(2 hours ten minutes)
Dr. Schreck: You know, I think it’s fine. The lack of information might not be a good idea (unintelligible) two different formulations, there’s a whole larger ratio between CBD and THC —
Lucas Nelson: Yep.
Dr. Schreck: — there’s a (unintelligible). So, looking at the least concentrated THC, with a ten to one ratio –
Lucas Nelson: Yes.
Dr. Schreck: — I mean, so if that’s all you care to explain about that?
Lucas Nelson: So, we yes. We kind of, you know, obviously I think that information was presented to you, probably from our RFP which was written in November, of 17? And as you can imagine things have changed drastically since then on some of the fronts. One of that was working with patients in this state and in other states and understanding what their needs were, what their concerns were, and so in looking at the best ways to address those needs and concerns we decided to actually up the amount of CBD that will be in those formulations. Thought that that would best serve what we were hearing from those patients who I think will be seeking that higher dosage and more concentrated CBD.
Dr. Schreck: Thanks very much.
Lucas Nelson: Sure.
Dr. Zadeh: I have a question.
Lucas Nelson: Sure.
Dr. Zadeh: One of the feedback that I get from physicians that I know is we’re concerned about who is recommending what these patients take. Can you tell us about the education of the, the potential education of the um,
Lucas Nelson: Dispensaries? Absolutely. So this is 100% a concern of ours. Something that we identified since we wrote this application. Um, what we are doing is a couple different things. So, part of the way we’re going to try to make this very very easy for our patients is having those dosing instructions and some other materials that will accompany it. And also develop our products in ways that will make it very easy to know exactly how much you’re taking. For instance, in our tinctures there is lines on the dropper that shows you exactly how many milliliters you have that corresponds to information on the outside of the packaging that says how much that is. So there we want to make it very very simple for our patients to understand how much they’re taking.
From there we have a titration schedule or instructions that are built out. We will put all of that information together, we will be educating, in fact we have already set up meetings with other dispensaries, and obviously our own, dispensary and agents. But educating them on what we recommend, based strictly on scientific literature, and most of that would start at a 5 milligram dose and proceed up from there depending on the condition. Now for some who may have experience in other ways hypothetically, there’s certainly other options where they could start at another dose, and we’re happy to have those discussions with those patients. One of the other things that we haven’t formally announced yet but that we’re trying to develop is basically an on time way for physicians if they choose, and the patients if they choose as well, to kind of collaborate and share data among all three parties. So that would be with the dispensary, with their physician, and the patient. And what that would allow is some interaction to say look, this isn’t working at this particular dose, what should I do next? And should I start feeling a particular way, and I think we need to trim this back. And that gives us the ability to work with these groups and say, OK, that makes sense, let’s start you here, and let’s increase that dose a little bit. Obviously it’s going to be voluntary participation, and it may be slow going at first. So that’s another aspect that we wanted to implement at least in our dispensaries to really help in that discussion. The dosing protocol like I said has been compiled over 60, 80, 100, I don’t know how many papers off the top of my head. That is by condition, by symptom of those conditions. So we certainly feel pretty confident about that. We’re also developing a, what will hopefully basically operate as a starter pack. Rather than diving into a full product, buying 30 capsules, or buying an entire tincture bottle, this will give you an option to slowly increase. So you start at the 5 milligrams, and you try that once a day for 3 to 5 days. And then in this pack, your instruction would be, depending on your response, then you increase to maybe 5 milligrams at the beginning of the day and then maybe 5 at the end of the day. And then see how that goes. And then again if you’re not getting those responses to slowly step it up from there.
(2 hours 15 minutes)
What Dr. Smith said is absolutely true and what we’ve heard in the other medical states is, starting at a low dose and slowly increasing from there. Certainly we can’t promise that everyone will follow that advice as soon as they leave our dispensaries, but we’ll be doing everything we can, both from the time the patient walks in and has these discussions, we’ll have obviously availability to call in if they’re having issues, if they choose to do that. Reach us online. We’ll try to make as many options available so that each patient feels that they can come back and look at us as a resource for what do I do next.
Dr. Zadeh: Thank you.
Captain Mike: Any other questions? Alright. Thank you.
Lucas Nelson: Thank you.
Captain Mike: Next item on the agenda is just to prepare for the next regularly scheduled meeting for this board and that’s going to be Friday, November 2nd, 2018.
Sarah Reisetter: Let me just add to that really quickly. What we will also do, is um, I just was talking to Jen over here, we need to get 2019 dates on your calendars, so in between now and the next meeting we’ll also send you what those look like for the board meetings for 2019, see if we can get those, get those unlocked.
Captain Mike: Last item is uh, we’ve come to the conclusion of the meeting. Um again, I want to appreciate the audience, the board, the staff, all that, for participating. We had a long list of items today. I would entertain a motion to adjourn.
Dr. Schreck: Do I get to call it?
Captain Mike: Ok. I guess so.
Dr. Schreck: I do didn’t want to interrupt earlier, but (unintelligible) is very well done, and very interesting. We talked about the definition of pain, and you know, I’ve been so (unintelligible). Now Minnesota used the term, I can’t think of the expression here, but the pain (unintelligible). But if we have a patient that says, I don’t want to use opioids, well then for that patient opioids are not (unintelligible) now. You know, if you have a patient that says sure, I’ll get more powerful surgery, but you can’t give me a blood transfusion. Well, ok, we do the best we can without a blood transfusion. So I think her idea of changing that definition would have been nice to start off with. But we’ve got that covered, (unintelligible) from the patient would actually cover that.
Number two, we have an issue that I’d like to consider. We voted way back that this medication would be an acceptable form of medication. And we didn’t get it past the Board of Medicine. Which I was surprised. I understand they thought it was bad optics, and many of you have expressed (?) as well, but Dr. Smith’s presentation today, as we know more and more about this, I suppose that we should revisit with the Board of Medicine. Um, the um, five year, saw this as, Debbie, I didn’t realize myself, these tiny issues that take so long (unintelligible). If we were to go back to the Board, and we were to take Dr. Smith with us. And, go to that with what we now know. I don’t want to irritate them, I don’t want to make them mad, I don’t want to waste their time. But we were going to it anyway, so this would improve communication. (unintelligible) In fact I was making it a motion that we should reapproach the Board of Residents about vaporization. Looking for a second.
Sarah Reisetter: Yeah, I mean, I think it’s, that’s kind of problematic, because we didn’t have that particular item on our agenda today for the Board to actually take action on. Um, it’s something that we could put on the agenda for the, for the November meeting.
Dr. Schreck: I think I understand. Thank you.
Dr. Guy: I don’t disagree with Dr. Schreck at all. I think we are going to have to have a convincing argument. I think we didn’t have a convincing argument, because we didn’t think that they were going to question that. And one of the docs on there is a hospice doctor, and she had kind of understood and was trying to argue for us. But I think we’re going to have to refine our argument a little bit. In mind of that, some of the people have reached their terms and there’s new people. I just think that we’re going to have to sharpen that argument which I think we can do. With new information that we have I think we’re prepared, I just think we’re going to have to be a little sharper about that.
Sarah Reisetter: We will plan to put that on the agenda for November, for your November meeting, to have a discussion about moving that recommendation forward again to them. And I think it would come in the form of a proposed rule draft, so, um, we can draft that up and put that on the agenda for the November and then you guys can talk about strategy.
Captain Mike: Any other comments or discussion? Ok. Is there a motion to adjourn?
Dr. Liesveld: Motion.
Captain Mike: Is there a second?
Dr. Guy: Second.
Captain Mike: All those in favor say aye.
“Aye.”
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