Iowa Cannabis Advisory Board Meeting, Valentine’s Day 2020, Part 1
Runtime: 2 Hours 18 Minutes
Unofficial transcript prepared by Jason Karimi
Audio and video originally provided by MedPharm Iowa’s Facebook LiveStream. Backup of this video is available here: https://weedpress.wordpress.com/2020/02/14/iowa-cannabis-advisory-board-meeting-valentines-day-2020-part-1-video/
Moderator: Let’s take a roll call here. Dr. Cheyne? Dr. Liesveld?
Dr. Liesveld: Here.
Dr. Miller?
Dr. Miller: Here.
Dr. Richards? Dr. Schreck?
Dr. Schreck: Here.
Dr. Stoken?
Dr. Stoken: Here.
And myself. Next let’s move on to the approval of minutes. It is time to approve minutes from the November 1st 2019 Iowa Medical Cannabidiol Advisory Board Meeting. Has everyone had a chance to review these minutes, and are there any questions or edits to the minutes? Ok. I would like to entertain a motion to approve these minutes.
Dr. Schreck: So moved.
Ok. So we have a motion by Dr. Schreck to approve is there a second?
Dr. Liesveld: Second.
Ok. Is there any further discussion? Hearing none, all those in favor say I? Those opposed say nay. Ok the motion carries and the minutes are approved. Next up from the audience we have a public comment period. We’re going to allow three minutes each. We have set aside this time to allow members of the public who would like to address the board to speak. All speakers are asked to keep comments to three minutes. If you have not already done so, please sign in on the sheet at the entrance which we have up here. So is there anyone who has not signed the sheet to speak today? Ok. First up on the list I have John Fenner. If you would please approach the podium and we’ll start the clock and you may begin.
John Fenner: Hi my name is John Fenner. I’m from Ottumwa. And what I’m trying to find out more is how we can increase the THC levels that’s in, that’s currently (unintelligible). Right now, the levels that we have are 3%. To be totally honest that’s uh, to be totally honest what I’ve understood from different people, that’s basically taking one Tylenol extra strength every nine days. I’ve talked with the Governor herself twice, I’m a veteran, Navy veteran I was in the Navy. Met her on the Capitol and we talked. Her concern was that it might turn into an opioid epidemic. So she did not want to proceed and try to make the increase if possible. I met her again. I was on opioids for a long time. I got hurt in 2012. I’m on a pain pill that’s called (unintelligible). Not addictive non-narcotic. It helps me. I can use my leg now but I still live in pain. The amount of THC that I am getting from this, it’s not doing what needs to be done. I had approved for a medical license in Illinois but I couldn’t get it because I lived in Iowa. I had to give up my Iowa residence. It took a long time to even find a doctor to approve me for a medical license. And then when I got the medical license, went to there expecting relief, and found that I had to pay $78 for a bottle of oil that I had to put under my tongue and that it had basically nothing so that it made my tongue real oily. I think it’s time that we need to increase this to make it work. What you’re doing now, I hate to say this, but you’re making me be an illegal person buying stuff that I need to get what you guys aren’t supplying. You’re not getting me the quality. You’re not getting me the um, the amount of options that I have to choose from. I don’t want to go back to opioids. I got off of opioids because of illegal marijuana. I don’t want to take illegal marijuana. So when I have my license I was excited. I’ve been to Illinois medical license, medical dispensaries. I’ve been to California’s medical dispensaries before they went recreational. That’s the type of stuff that I was expecting. When I showed up at the Iowa one, I saw what we had to offer and that was embarrassing. It was not worth my trip. It was not worth my time. It was not worth the cost, and I don’t understand why we cannot increase it. I don’t understand why, if you go to a Walgreens in Illinois, Iowa, wherever you go, and you get your medicine, it’s the same. It’s not changed. We’re not going to take a little less out of here because you’re from here. And going through some of the rules that –
Moderator: We’re out of time.
John Fenner: Alright. I will get out of here and make it quick. But um, my last thing is we, if this is gonna work, you need to help us. You need to allow us to help treat ourselves. You’ve already given us permission to do this, and now you’re limiting what we can get, and I think that’s wrong. I appreciate your time, and I appreciate the board. I don’t know where the problem –
Moderator: Ok, sir, I have to move on to to the next speaker. Hannah Van Houten?
John Fenner: Thank you for your time. (5:44)
Hannah Van Houten: Thanks. Hi my name is Hannah Van Houten. I am 21 years old. I’m from Des Moines Iowa.
I’m currently a pharmacy technician and hopefully I am a future pharmacy student here in Iowa. Um. I am here today because I love someone with a permanent disability due to a life threatening car accident and medical marijuana saved our life. Um. Without it that person would still be relying on opioids and alcohol to help ease the constant physical and mental –
Moderator: Please mute the phone on the other line.
Hannah: Sorry about that. Um. Without medical marijuana, that person would still be relying on opioids and alcohol to help ease the physical, mental and emotional pain they suffer from. Aside from my personal experiences I see every day at the pharmacy that I work at that the opioid epidemic is very real and very scary. It’s taking over people’s lives, and they need access to alternative options, like medical marijuana, before it’s too late. Chronic pain, seizures, PTSD, anxiety and depression, Parkinson’s disease, and autism are just a few of the medical conditions that can benefit medical marijuana. Rather than over prescribe medications which can be addictive, and spreading harmful toxins throughout our bodies. Raise the limit, remove the cap, and make medical marijuana more accessible before it’s too late for those people.
Medical marijuana saved my dad’s life. Imagine what it can do for you or someone you love. I believe this is a solution to treat physical, mental, and emotional pain, as well as putting a stop to the opioid epidemic in Iowa and in the United States of America. Thank you.
Moderator: Steve Van Houten?
Dave Van Houten: I’m Dave Van Houten, from here in Des Moines. Thank you for your time. Um. I got a little story I’ll share a bunch of it as I can with ya. My story begins December 15th of 2016. I was involved in a very serious car accident involving 16 broken bones, 2 torn rotator cuffs, unrepairable, shattered wrists, unrepairable, broken pelvic which they had to remove part of it, dislocated hip, along with other injuries. After eight surgeries and hours of therapy, accelerated arthritis, anxiety, and depression set in, followed by an addiction to opioids and alcohol. After family intervention and realizing that vomiting in the morning waiting for your pain pills to kick in, was actually withdrawals to opioids. I checked in to a treatment center in Chicago and returned home to find a MedPharm program, excited they could help me through my next surgeries. I cancelled two surgeries to receive this treatment. After trying the program with some success, I found the three percent cap on THC extremely limits the pain relief. I still the year after have not scheduled my surgeries in fear of an opioid addiction. The THC cap which was removed in medical programs in 13 states, resulted in a 33% decrease in opioid overdoses. The years following that, the answer to our opioid crisis, while we are sitting on our hands, because for some reason, people with a proven non-addictive non-lethal alternative is not as safe as prescribing more opioids than needed to kill me. Thank you. Can I see a show of hands of anyone who has been prescribed opiates on the board?
Sarah Reisetter: This really isn’t a back and forth with the board members, it’s just not a good idea for people to –
Dave: Ok, I was just curious on decision making with people, their background, experience.
Sarah: I completely understand.
Dave: Oh. Thank you for your time.
Moderator: Travis Floyd?
Travis: My name’s Travis Floyd. I live in the Des Moines area. I’ve got a background ranging about 17 years working with patients in psychiatric units. Community based mental health crisis intervention, inpatient, long term care, as well as working in emergency departments. Last five years, I left that career to pursue influencing on a larger scale both all around the United States in different states as well as in Canada. Hopefully even further in the future. I did that because of my professional experiences observing the mental and emotional trauma that a lot of people go through as a result of their background, whether it’s familial (?) history or physical pain (?) history and recognizing that the systems that are in place just simply don’t work, and a lot of times I’ve experienced my own personal experiences in family experiences of people who have been consistently fed pharmaceuticals that are just not good for them that cause other side effects that precipitate their own mental and emotional wellness continuing to decrease and be degraded by a system that is educated in a way to push pills in opposed to pushing improvements. One of the biggest things that I have seen that is a barrier to being able to improve outcomes in patient populations in every state, and the places that do it well I’ve found are people who listen, just as these people are saying, who listen to the people who are actually experiencing it. So I urge you to make sure that you continue to have panels and hear commentary from the perspective and viewpoint of what these people are actually going through on a regular basis, listen to it, put yourself into their circumstances, and understand what it might take to overcome some of the fears that have been put into people, based on the societal viewpoint, in what has been the quote unquote war on drugs, which often times has been a war on people who really just need a better opportunity to treat their own lives and their health and wellness. Thank you.
Moderator: Dr. Corey Burchman?
Lucas Nelson: Dr. Burchman’s going to be presenting. Sorry, he just –
Moderator: Ok. Wes Breckenridge?
Dave Holt: Wes had to leave.
Moderator: Ok. Rebecca Lucas?
Rebecca Lucas: Good morning. I wanted to discuss two of the items on your agenda for today. The first one is number 9 part C, the process discussion. And as many of you have probably been following, at the last Board of Medicine meeting, PTSD was denied. Dr. Miller defended that. This was the same thing that happened to chronic pain. When you guys sent it to Board of Medicine, and Dr. Schreck defended that.
Specifically, why it was denied was for not having the correct phraseology of refractory to standard treatment. Um, this has taken a lot of back and forth time as it gets bounced from the Board of Medicine back to the Medical Cannabidiol board. And rather than wait until the next meeting, when petitions can be resubmitted with that language, I think that it would be permissible today under 9 C to, as a board, discuss adding these qualifiers and consider sending these petitions to the Board of Medicine today rather than wait. Therefore I would humbly ask you to take a little bit of time during this process improvement agenda item to discuss and ultimately send back both chronic pain and PTSD with the qualifier of refractory to standard treatment.
The second agenda point is the potential limit on petitions per condition which is agenda item 10. The board’s rule is to discuss forms, quantities, and also new conditions. You guys were put in place because of knowledge, but also because of the flexibility that the legislature just doesn’t have. They’re able to meet one time a year, you’re able to meet four times a year. This gives better access to petitioners but also to potential patients who make up these conditions. Further showing your commitment by setting up a separate committee in order to review petitions. While I’m unsure exactly what your discussion will hinge on later today, I would like to express my concern to limiting certain conditions to particular time period before they’re resubmitted. New research comes out all the time, and the ability to stay agile, and even to potentially submit a condition up to four times a year is really important as really a boon to patients who could benefit from those conditions. So I would like you to consider that in that agenda item as well. Thank you.
Moderator: Michelle Servadio?
Shelly: Thank you. Good morning. Thank you for having me. I’m a recently retired nurse, (something) cannabis nurse. I’m also a state patient, so I have standing under the law. Couple things. 4.5 grams in 90 days is a death limit that will cause me injury. Under the law, I have standing as a patient. You’re here to serve me, and I’m telling you, I use more than that in a month. It’s not therapeutically beneficial for my (too quiet to hear), so I’m gonna ask you, where in the United States, evidence based practice, does that work? And how can that possibly work for several medical conditions as a blanket dose? Please pause. You’re to do no harm. You are to not have political bias in your medical decisions. That’s the first thing I want you to stop and think about. Second thing. 124E.7, we’re gonna, I’m gonna ask you, because you’re going to be (something) yourself for medical cannabis, smoking prohibited, please amend, does not include because you have the form vaporization is already approved by both medical boards. Form, vaporization, treatment options, approved by medical board, will be exempt. On the other side of the House, legislative wise, we’ve got a lot of things going on because we want to ban vaping, because of the vaping illness I understand that but again I am a patient, I have standing under the law, medical forms of vaporization have been approved, I go home, what I do in my own house is my right because I have this card that is medicine and it should be exempt because it’s medical.
I’m not using recreationally. What I’m doing, is medicine. And I’m asking, you guys, to please step in, and exempt this, from what’s going on, because they’re trying to ban everything. This is a simple thing. It’s already, the law, in 124E. You guys have already done this. Please codify it. Please recommend to the legislators to exempt it. Please take care of that. You’re already relating your board. Please do it thank you so much. Appreciate your time.
Moderator: Michelle, Servadio?
Shelly: Servadio Elias. Veteran.
Moderator: Carl Olsen?
Carl Olsen: Owen, if you would be willing to distribute it for me? Thank you. Good morning. Um, the Department of Health denied a request that the Board approved for federal exemption for Iowa’s medical cannabidiol act, and that would be Iowa Code Chapter 124E. And pursuant to the federal controlled substances act, the section that talks about positive conflict with state law, and federal regulations 21 CFR 1307.03 which are the controlled substance regulations where the exemption procedure is contained. So the Department wrote that neither the DEA nor any other federal agency has taken any adverse action that we are aware of. And that was on January 7th of this year. Last year on September 23rd, Attorney General Tom Miller wrote, beyond imposing on state’s rights, the status quo poses a serious threat to public safety. So I think these positions are inconsistent with the Department and the Attorney General.
Um, two bills have been filed. On your agenda, item 11, you have these two bills. House Study Bill 653 and Senate Study Bill 3136, which attempt to address this issue by saying the Department will obtain a guarantee from the federal department of education and the federal department of health not to withhold funding as a result of the implementation of our Act. And, I’ve asked the Department if they know what they will do if that passes and they don’t. That’s not very clear. It needs to be a federal exemption across the board for Schedule I.
The Department of Justice and the Administration say they will no longer honor the former administration’s policy of non-enforcement of federal law, and any assistance the Board can provide in lobbying for better language in these bills would be appreciated. Thank you.
Moderator: Flora Schmidt?
Flora: Good morning. I’m Flora Schmidt, the Executive Director of the Iowa Behavioral Health Association. We represent mental health and substance use providers across the state of Iowa. I just came to let the Board know that we have registered in support of House Study Bill 653, which is a medical cannabidiol act that held a subcommittee this past week. This, um, what do you want to say, House Study Bill, has the majority of the recommendations that this Board has put forward in the past. We have supported the majority of those recommendations, and we continue to support them. We specifically like the fact that you are looking to expand the prescribers, the mental health practitioners, practitioners who can help with the registration cards to get more people access to the product as they’re needed. We do though have adamant support of the 4.5 grams over 90 days. We do not believe that going to higher levels is beneficial to the overall public health of this state. There are other opportunities through treatment that are available, and we just want you to know that we are one of those organizations that watches what the Board does very closely, and we want to continue to support your recommendations, and we hope that you will continue to maintain that 4.5 grams moving forward. Thank you.
(23 minutes 12 seconds mark here)
Moderator: Mike Nixon? Am I pronouncing that correct?
Nixon: Nixon.
Moderator: Nixon. I’m sorry.
Mike Nixon: Good morning. My name is Mike Nixon, I’m just a guy off the street. I don’t have any papers with me. I am a ex-Navy C. I joined the service when I was 16 years old, left the day I turned 17 on a delayed entry program. My first deployment was Guantanamo Bay Cuba as a Haitian-Cuban defector guard. I worked closely with the CIA and the token various defectors from other countries, Cuba, Haitia, and Asian villages, and we interrogated them. That was my first exposure at 17 years old.
I have been to Lebanon, Beirut, I’ve been to Grenada, I’ve seen a lot of conflict, and have been involved in a lot of conflict. I have been diagnosed with PTSD. That’s what I’m here for today. I have no horse in this race but as far as THC and you know, medical marijuana, I don’t have a horse in that race. I just wanted to explain to you the medicines that I take for the PTSD and what they do to me.
I take Deloxatine, I take Miniprex, I take another Benzo, I don’t even know what the name of it is. I have lorazepam with me wherever I am and am going to be. I am never without it. I do have a job, I am high functioning. I’m a director of IT and I code for a living, and I have to keep my mind busy to keep my mind off everything else in my past. I have not had a good night’s sleep probably since 1984. Um, I wake up at 2 o’clock every morning, nightmares. I know what death smells like. I know what war feels like. I know what conflict feels like. And the reason I did that is to stop everybody else in this room from having to experience that, and my children from experiencing that. I made a sacrifice for my family and my fellow citizens. So, I don’t blame anybody for what I have. PTSD is mine, I own it. But the medication makes me rock in my chair, it wakes me up every night at 2 o’clock, it makes me jitter, it gives me little lightning bolts from this side or that side of my eyes, it causes me pain down the right side of my body. And if I don’t take it, I am very quick to anger. I fight with everybody, I’ve been to jail because the medicine controls it, and PTSD is something that it it it it’s just a (keys jangle). I fight with my wife, I argue with my kids if I don’t take it, so I have to take it. I haven’t, I haven’t, it affects my love life with my wife. It affects my ability to go somewhere by myself. I can’t really travel.
I love CBD. It works good, but then –
Moderator: We’re at the three minutes. You wanna wrap it up real quick?
Mike: Ok so. I’m here because my CEO, um, made it an announcement that CBD is illegal. And I was taking that, and I was healthy. But now I have to rely more on the medicine that causes all these nasty side effects, because I can’t take the CBD anymore, so anyway that’s what I’m here for. I know you guys have a problem with understanding, you know, who gets PTSD or somebody that’s served in the military so.
Moderator: Alright we’re done.
Carl Olsen: Thank you for your service.
Moderator: Thank you everyone for your information and opinions. We appreciate you sharing that with us today. We’re going to move up to item five on the agenda. Petitions to add qualifying conditions. Sarah Reisetter, Deputy Director of the Iowa Department of Public Health, is here today to lead our discussion and consideration of petitions listed on today’s agenda. Thank you Sarah.
Sarah: So again for this meeting, for these two petitions that have been received, we have turned those petitions over to the subcommittee that you guys established as part of your August board meeting. And so Dr. Schreck, and Dr. Liesveld participated on that subcommittee. I think the first petition on that agenda is panic disorder. So did one of you want to review the subcommittee’s work related to that particular condition and explain the research in your recommendation?
Dr. Schreck: Yeah for the explanation this subcommittee was setup last year because we were getting very good petitions, petitions that were well referenced, including all the way through 30, 40, 50, 60, 100 references. And um, most of these doctors are full time practice and don’t have a whole lot of time to study these in detail, (29 minute 14 second mark) so we thought we’d break it up and divide the labor and have a few physicians basically review the medical literature. Let me make that a bit of an intro comment here, because this has been referred to several times.
We as a medical advisory board, cannabidiol board, we were created by the Legislature because they wanted to hear what medicine had to say about medical marijuana, about cannabis as a medical treatment. And that was what we were established for. I saw it myself, and I think that’s been confirmed, as part of a compromise between the legislature to come up with a program that would enable patients to obtain medication to see if it benefited them. It was specifically designed to be a limited program. That’s in quotes, “limited program.” Evidence for that was in the cap of THC content, not 23 but 3%, and the very creation of this board is evidence of the fact that they are looking for an evidence based, limited program that our first venture into medical cannabidiol here in the state of Iowa. So our study committee was set up to enable us to look at these things in detail.
The panic disorder research we’ve reviewed here is of course all the petitioners reference this – basically one, it was a good reference, it was published in 2017. It’s a review article. It cited 65 public references of which 63 were lab studies, global studies, or descriptions of the disease itself. As a matter of medical honesty, we do not in any of our medicine, prescribe our medications based upon anything other than studies on human beings. And in this list of 63 recommendations, there were only 2 studies on human beings. One was from 1993. That was a placebo controlled randomized controlled trial studying four groups of 10 healthy subjects, but none of these people had panic disorder. They were normal healthy adults. In fact the word panic disorder does not even appear in the article. The other study referenced about human beings was in 2011. None of the study subjects had a diagnosis of panic disorder. The term panic disorder does not appear in the article. The summary itself, um, the summary itself, in the conclusion, they stated, however it is important to stress that we are just in the first steps in the route to getting possible final approval of CBD for the treatment for panic disorder. Here they’re talking about CBD, CBD only, not with any THC content. THC itself can cause panic disorder, so they specifically did not include that medication in their treatment plan. Therefore new studies conducted with a reasonable number of panic disorder patients, Phase II and Phase III studies, are necessary, to demonstrate the efficacy and the dose range of CBD for the treatment of this anxiety disorder. This update itself did not recommend treatment, it recommended further study. For research up to date, which is an expensive website which is literally up to date, first in using the term treatment of panic disorder (something) pharmacology for treatment of panic disorder with or without agoraphobia in adults. This lengthy review does not mention cannabis, marijuana, CBD, or cannabidiol, as either established therapy, nor treatment under study in the text in these references. It was last updated January 20th, 2020.
Um, so the subcommittee voted based upon the review of the medical literature. (33 minutes) Keep in mind the only way medicine can speak, is from the literature. That’s where it speaks from. We cannot ourselves make it up. We can’t allow our own personal biases, our own libertarian tendencies, to impose here. That’s not our job. Our job is to address what medicine says. And medicine speaks from the medical literature. It’s a hallmark of what responsible physicians do to prevent causing harm. Which of (mumbles). The committee voted three to zero, unanimously, to recommend rejection of the petition based upon the review of the medical literature. (Unintelligible mumbling) of women’s, moreover, of women’s studies, presented by the petitioner, did not address panic disorder.
Kind of a lengthy explanation. This is what we do, this is how we talk about information. This is our role.
Sarah Reisetter: Thank you Dr. Schreck for your review of the subcommittees work. **Shelly Servadio raises her hand** Have all of the board members had an opportunity to review not only the petition but the subcommittees report that has been provided as part of the petition process?
Dr. Miller on phone: Yes.
Sarah: Ok. So I think at this point in time then we would be willing to entertain a motion to approve the petition?
Moderator: Is the petitioner here?
Sarah: Oh yeah, that’s right. We should do that. So, usually when the petitions come before the board, there’s an opportunity for a petitioner to address the board. Is the petitioner with panic disorder in the room interested in addressing the board before we move forward? Ok, so. With that, (unintelligible) it’s time for a motion.
Moderator: So, I would entertain a motion from the Board related to approving the panic disorder petition.
Dr. Schreck: I would move to deny.
Dr. Liesveld: I second that.
Moderator: Ok, so we have a motion, and a second, to deny the petition. Is there any further discussion? Hearing none, all in favor say aye. Ok, alright. This is to deny the petition. Um, Dr. Liesveld? “Aye.” Dr. Miller? “Aye.” Dr. Stoken? “Aye.” Dr. Schreck? “Aye.” And myself is also affirmative to deny petition.
Sarah: Ok. So the next petition received is on the agenda for your consideration today is the petition to add ADHD or attention, I’m not going to try it. Alright so, Dr. Liesveld or Dr. Schreck, did one of you want to update on subcommittee work related to ADHD?
Dr. Liesveld: I will update the ADHD petition. Mine will be shorter than Dr. Schrecks. My English teacher did not pay attention to detail as properly as Bob’s English teacher. So anyway, the subcommittee, each of us thoroughly reviewed the references sent to us by the petitioner. So, the majority of the references were single-case studies, lab reports, animal studies, and in looking at those, there was not enough evidence to indicate that using medical marijuana would be helpful for attention deficit hyperactivity disorder. There was one published uh, double-blind randomized placebo controlled trial looking at 30 adults with ADHD. The, you know, the number in the study was fairly small, and looked at some symptoms of ADHD including hyperactivity, inattention, and impulsivity. And, the results of those studies were inconclusive. There just wasn’t enough evidence to meet statistical improvement in those symptoms.
So uh, we also did a pub med search, which really didn’t result in any real conclusive evidence, from the time that we denied this petition back in November of 2018. And I would also add from a clinician’s perspective of treating many many many individuals both children and adults with ADHD, I have seen actually potential harm from particularly adults using marijuana in an effort to treat their ADHD. It actually can, and there is evidence within the literature suggesting that cannabis can worsen memory, attention, and those sorts of things, and really can have an impact on academic performance and social performance as well. So the subcommittee, consisting of myself, Dr. Schreck and Dr. Stevens, did vote unanimously to deny the petition for adding ADHD as a qualifying medical condition.
Sarah: Thank you Dr. Liesveld. Is the petitioner for ADHD in the room and interested in addressing the board this morning? Ok. Have all board members had an opportunity to review the petition that was submitted and all of the research um that was conducted by the subcommittee?
Moderator: Alright. I would entertain a motion from the Board in reference to the ADHD petition.
Dr. Schreck: Move to deny.
Dr. Miller: Second.
Moderator: We have a motion by Dr. Schreck to deny the ADHD petition with a second by Dr. Miller. Is there any further discussion? Ok so we’ll take the same role call vote when I announce your name, if you’re voting aye or affirmative you’re voting to deny the ADHD petition. Dr. Liesveld? “Aye.” Dr. Miller? “Aye.” Dr. Stoken? “Aye.” Dr. Schreck? “Aye.” Myself is also aye or affirmative. Ok we’re up to item six on the agenda, the Manufacture and Dispensary updates. So, welcome to our manufacturing and dispensary representatives in the audience who are here with us today to provide updates to the operation. First up is Dr. Corey Burchman, of Iowa Relief or Acreage Holdings?
Dr. Burchman: Good morning. Thank you for the opportunity to talk. So, a little about me. I am a clinician, just retired from medicine after a 37 year career in anesthesia and pain medicine. And uh, strictly taking care of patients.
And by disclosure, I am employed now as the Chief Medical Officer at Acreage Holdings, which is a large cannabis company. We’re in 20 states. And I have visited all of those states, and I have addressed boards such as yourself. And as well, I’m a member of the Cannabis Oversight Board of New Hampshire.
But I am not a hammer looking for a nail. I am not a marijuana doctor. I’ve been taking care of patients in the operating room all of my life. And probably have treated thousands of patients with medical cannabis, as well as conventional therapies –
Owen Parker: Please mute your phone. Thank you.
Dr. Burchman: — conventional therapies over the last 30 years.
In any event. So I stand before you mainly as a clinician today. I want to start off with a little story. Ok, I was taking care of a patient, her name was Helen, she had metastatic breast cancer. And uh, she probably had weeks to live. I was called in to help manage her pain. Uh, she was on oxycodone several times a day which is a high release extended opioid. She was on a fentanyl patch. She was on a morphine drip. And in between the times when she was comatose and stuporous from her meds, she was awake, moaning, vomiting from her chemotherapy –
Owen Parker: Sir, please! Mute your phone!
Dr. Burchman – in a stuporous state. Another patient of mine, Marilyn, had multiple sclerosis. Severe spastic multiple sclerosis. Also came to me on high dose opioids. Uh, but at this point Pennsylvania had medical cannabis, and I treated her with a tincture of 2.5 milligrams of THC twice a day. That escalated to about 10 milligrams twice a day. And we were very successful in weaning her off of her opioids. THC happens to be an excellent antiemetic which means her vomiting was relieved. And she also died in about three or four months, but she was surrounded by her loved ones, fully cognizant of her surroundings. The difference in these two patients, the difference between Helen, and Marilyn, was 25 years. One was 1987, and the other was in the mid 2000’s when medical cannabis was available to me and my patients.
So, that’s a story. And a story moves. A story moves. But I’m a data driven, evidence based physician, so I need data. So, one thing I talked to my residence for the last twenty years, a story moves, but the data proves. And for a physician to embrace this modality, you need data. And one thing I hear from legislators and physicians from all over the country is show me the data. Where is there data on medical marijuana, uh, on medical cannabis? I care about it, it’s anecdotal, but I don’t know where the data is.
Well I’m here today to tell you where the data is. I’m sure most of the physicians among us are familiar with PubMed. You know, a branch of the National Library of Medicine. It’s a database of 30 million articles — research studies – from 7,000 of the most curated, finest medical journals in the world. It’s a global database. And that stream of information grows daily. By tens of thousands of articles. So if you do a search, for marijuana, in this curated, world’s finest database, how many articles do you think you’d find? Well, I did it last week. There were 31,600. Thirty-one thousand six hundred articles on cannabis, on medical marijuana research studies, ok?
So just as a method of comparison, Tylenol, alright? Very common drug, it’s been in continuous use for sixty years. Do a MedLine PubMed search for Tylenol. 21,000 articles. Twenty-one thousand articles on a common medicine cabinet drug that we all use. Thirty percent more articles on marijuana. I could go on. I know I don’t have a lot of time.
Humera, which is the largest selling drug in America, made twenty-two billion ($22,000,000,000) last year. You know how many research articles there are on Humera? Eight thousand.
So marijuana, which has been around in continuous use for five thousand years, has more research studies and papers written in very reputable journals than, than actually Tylenol, Prozac, Xanax, and one other one I forgot, but anyway, marijuana is an extremely well studied drug.
But anyways, ok, I want randomized, controlled trials. That’s what the FDA likes to see. Crossover randomized controlled trials, for marijuana, it’s about a hundred. A hundred clinical controlled trials. Which doesn’t really sound like a lot when you’re thinking about thirty-one thousand studies, right? It’s really not. But if you take a look at how many randomized controlled trials the FDA wants to see for novel drugs, you know, drugs that are going to be up for FDA approval? My buddies at Yale did this study, this was a great study that was published in the New England journal of medicine. The average number of randomized controlled trials that a drug, a novel drug gets, before FDA approval, is two. And forty percent of those drugs only get one controlled trial before the FDA approves of it. So when you think about cannabis, a hundred controlled trials, that’s pretty good. That’s actually a lot of data.
So where is this data? How can I produce this to you? Well uh, one of my colleagues, Theresa, I sent her a whole bunch of blanks, and I will make all of that available to you.
One of the go to references that I used to educate physicians nationally is a five hundred page document put out by the National Academies of Science Engineering and Medicine. It used to be called the Institute of Medicine. It’s a very reputable, private, not-for-profit institution that deals with American issues regarding technology. So the Institute of Medicine put out an initial study on the health effects and therapeutic use of cannabis in 1997. And then in 2017, 20 years later, they revisited. And it is 500 pages, there are over 35 – I have a link for you – there are over 3500 references, and it’s the real deal. And it doesn’t say that cannabis is great for everything. But it’s very well researched by doctors, you know, with global reputations, but United States physicians. And I stand by it in terms of the gold standard by which we need to judge the efficacy of cannabis. So the research is out there.
And then I produced just, at the last minute, a little paper, it’s five pages, and you’ll get that copy as well. And that just gets you a few examples. I mean I could choose one out of thousands of articles, and so it was really hard, like, I know that the focus of this meeting today is to discuss doses and caps on doses. How much drugs should a patient get. And so I tried to distill some really essential ingredients in these papers, and you will get those. But what I want to say, and I made them bring this up here because I want to show you something. **Moves to easel** Alright, first of all, there’s a huge amount of variability in doses. Marijuana is actually a botanical plant that has maybe three or four hundred active pharmacological compounds in it. And the only one that’s psychoactive is THC. Alright. It happens to be therapeutic, but there are many other compounds. But my point is, it’s not like ibuprofen, which is consistently 200 milligrams per capsule. So, it’s very difficult to dose cannabis. And there’s huge variability for many reasons. Different patients have different genetic predispositions on how they handle drugs, uh, they have different conditions, they’re taking medications that other patients aren’t taking. So the response to a patient getting a drug can be different even though they have the same disease. But the point I want to make, is when you talk about – and and and, drugs and doses is my thing, I’ve been giving drugs to patients all my patients in anesthesia, so I know the pharmacology stuff really well, and I’m not going to lecture you about it, but this is a very simple concept, ok? This is a curve. It’s a bell shaped curve, alright? And this line, is dose. Ok? Dose. And let’s just pick a number. Let’s just say the dose is 5. Ok let’s call it 5 milligrams. And this, this line, is the number of people that respond positively to whatever – let’s just say it’s a patient with back pain, chronic back pain, I’ve had a million patients with multiple back surgeries that have really bad back pain.
This is called a dose response curve. And this is the average. This is where most people respond. So when you read about doses in your journals, and you referenced some, and you say ok, the average patient responds to five milligrams. That means that half the patients respond to more than five milligrams. Do you understand? Because this, this is the average. So if everybody here who gets five milligrams, they don’t get complete pain relief. So normally in medicine, we, we create a range, alright, that’s called a standard deviation. My point is, that when you deal, when you read these journal articles and you look at averages and you say ok, the average is five. That means that there is a proportion of Iowans, if you will, that will not get relief. And we’ve heard some very compelling stories today about patients who are below their their, they’re below their therapeutic levels. And my point is, at least in this state, I study this for a living now, and I’ve seen it in many different locations. The particular number that we’re dealing with, 4.5 grams over 90 days, that works out to about 50 milligrams of THC a day. That’s, that’s probably ok starting. It’s probably ok for a proportion of the patients. But if my mother with end stage multiple sclerosis and neuropathy, who cannot sleep at night unless she gets 50 to 75 milligrams every four hours, she’s not going, she’s going to fall outside of that range. And that’s my range. We’re so focused on 200 milligrams every four hours. And my point is, because of the nature of cannabis, there’s dose variability that’s quite great, that you need to have, that wiggle room to allow patients to titrate and find that proper dose that’s gonna work for them. Ok?
Uh, so I think I covered most of the basics. We talked about the fact that there are a hundred, at least a hundred and growing randomized controlled trials. Cannabis, uh, PubMed is a huge depository of medical information, and I could bore you to death with the number of medical studies by very reputable review journals, and I included a few in my handout. And I’m happy to entertain questions.
**Shelly Servadio raises her hand**
Moderator: Are there any questions from the Board?
Dr. Schreck: Um. The uh, I’ll ask you a question that I’ve asked the manufacturers. Among these one hundred randomized controlled trials, can you show me one that studies doses that are being sold in this country?
Dr. Burchman: Oh yes.
Dr. Schreck: You can? Please do.
Dr. Burchman: I included it in my handout. The state of Minnesota has a very mindful program, and they published about a hundred page document that’s extremely well referenced – and I think I actually cite it in my uh – it’s called “A Review Of Medical Cannabis Studies Related To Chemical Compositions And Dosages For Qualifying Medical Conditions.” That’s exactly what you’re asking for. Exactly. And you can read that, and it divides the science into at least fourteen different qualifying conditions, and as I said, the average dosage, that a patient receives really. And I will tell you honestly, it’s a dose, and it falls within 50 to 75 milligrams a day, but again that’s the average. And by definition, an average means that half your patients will not get that. Will not get that. So my point is that cannabis is an extremely safe product. You will never – there are no receptors in the brain by which cannabis will stop your breathing, or stop your heart. Unlike alcohol, unlike opioids, unlike a host of other psychologically active agents.
And so my point is do we want to take care of 60% of our patients, or do we want to take care of 95% of our patients? If the safety profile is such with this drug, that by boosting the cap, by two-fold, which I think is still pretty moderate considering what other municipalities do. I think the safety is there and the benefit is certainly there.
Dr. Schreck: The um, Minnesota study you referenced has been studied in detail by our group. Read every word. Unless I missed something, that’s not a randomized controlled trial. What that is is a sales report. It reports what has been sold and the dosages patients have bought, limited by effectiveness, if it doesn’t work they’re going to quit spending their money, because it’s an all cash deal limited by how much money they have to spend. But Minnesota has no limit. There’s no limit whatsoever. It’s wide open. As much as you want to buy, you can buy. As much as you can afford to pay for. And so they’ll give us a sales report, which we’ll probably hear from our own manufacturer here shortly. A sales report is not science. It’s just that. It’s a market report. If I open a shop out in West Des Moines, in a strip mall, selling some other psychomimetic drugs, some other psychoactive drug. Let’s say an opiate, an amphetamine, which I could legally sell at no limit. What would I end up selling? What would the average be of people who bought?
Dr. Burchman: I respectfully have to disagree with you about it being a sales report. I, I have enumerated well over one hundred articles, from peer rev—when you have a journal article, from the clinical gastroenterological and journal of hepatology, that is a peer reviewed journal, in the index medicus, so that, there’s no bias in those reports. And again, my point is, that this particular document, which lists hundreds of journal articles, and demonstrates doses – when you hear a number for a dose, as I said, it’s the main dose that a patient is getting. Your circumnavigating at least half the patients. That’s my point.
Dr. Schreck: Well, I hope you don’t have to fly back soon, because I’d love to talk to you about this in detail, and face to face, and look over that information. Because (can’t hear). It’s not a randomized controlled trial. It’s not a clinical study. Their report, under 14 different medical conditions, the average dose, the dose range of what they’ve sold, what people have bought, not what is supported by medical science. That’s the whole point.
Dr. Burchman: Well –
Dr. Schreck: But we can, we’ll look after it.
Dr. Burchman: It might be a point where we can agree to disagree.
Dr. Schreck: Well, or maybe even get together. But that’s my concern. I’m no apologist. You know, I live in, that’s the briar patch in which I live. I don’t give people cancer treatments based on anything except evidence based research. Randomized controlled trials. If we’re going to take a novel substance, a novel drug, if you will call it, like medical marijuana, THC – and by the way, it’s always about THC. It’s always about THC. I think we’re somewhat engaged in a mass society drug seeking behavior here. Everybody wants THC. That’s what they want.
Dr. Burchman: Well, sir –
Dr. Schreck: If we look it up. If we look it up, and we think that they missed something, we’ll invite you to do what I asked the manufacturers to do, which they have not done yet, is to show me one study, that supports the doses that are being sold. One prospective randomized trial that supports those doses. I’d love to see one. I can’t find one. And what we’re here to do, evidence based medicine, not anecdotal, not uh, sales reports. Even the case you cited, the woman with multiple sclerosis, you cited a dose at 10 milligrams twice a day. That’s 20 milligrams. That’s supported in the medical literature. I agree with you that there are many many excellent randomized controlled trials of cannabis that supported (?) in some very limited circumstances, in a very limited dose.
Dr. Burchman: I absolutely appreciate your judgment and insight on that. My point is, when we talk about doses, in these studies, we’re discussing average doses, and there were dose ranges, and the range is what I was concerned about, because if we don’t get the people – uh, if we eliminate fifteen to twenty percent of the patients we’re trying to help, then what’s the point? What’s the point in doing it? And the other point you made about – I certainly do not consider cannabis a novel drug. This is a drug that has been in continuous use for 5,000 years, and in fact some people would say that it is, marijuana has undergone the longest clinical trial in human history.
Dr. Schreck: I would agree. If we could get rid of opiates and alcohol, and trade it in for unlimited cannabis, it would be a better world. Don’t get me wrong. But we’re asked to uh, look at the medical, medical evidence. Here’s another question. I respect the fact that you, your organization, goes to many states. You see I’m sure a lot of different, a lot of variations, a lot of approaches. To my knowledge, and I would love to hear more, Iowa is one of only two states of the thirty-some that have medical marijuana programs that has a board like this. A board composed of physicians. The only other one I know is New Mexico. Do you know one other state that has a –
Dr. Burchman: Yeah. I’m on the Cannabis Oversight, Therapeutic Cannabis Oversight Board for the state of New Hampshire. It’s all physicians.
Dr. Schreck: Ok. I wasn’t aware of that. Any other ones you are aware of?
Dr. Burchman: Uh, Massachusetts. Cannabis Oversight Board. Connecticut Cannabis Oversight Board.
Dr. Schreck: And these are all physicians?
Dr. Burchman: Yes sir.
Dr. Schreck: Given similar roles to what we have right here today.
Dr. Burchman: Yes, absolutely.
Dr. Schreck: So that’s, New Hampshire –
Dr. Burchman: Uh, you know, I live in New England, so that’s where I travel a lot. So New Hampshire, Connecticut, Massachusetts, Maine is a totally different country so we won’t get into that.
Dr. Stoken: So, um. We have a – we recommend a 4.5 gram over ninety days purchase limit, but we’ve also said that the purchase limit can be increased by the certifying healthcare practitioner, if that wasn’t enough with that patient. So we did add that qualifier in there. So they aren’t, they are – go ahead.
Dr. Burchman: Well that’s reasonable. I mean, I think, um. Obviously mindful medicine requires management and communication. And the fastest growing segment of cannabis users is between the ages of 50 and 75. These are not your stoners, these are not your tie-dye people that are looking to get high. I, I visit, and lecture, at medical dispensaries all the time. And every one, with rare exception, I don’t believe in superlatives, are patients. And they’re all so grateful. And remember when I said in the beginning, a story moves, but data proves. And I’m not getting, I don’t make a lot of money doing this. I, I expected to, I told you guys this, I expected to retire in April and paint and write, and I ended up doing this because I’m passionate about it, not because I’m, you know – this is not my retirement gig. But, I think as long as there’s mindfulness in the physician-patient relationship, and that physician cares enough to follow up, this is not a, this is not an instrument of harm. In fact, the Journal of the American Medical Association, a very reputable journal, my friend Martin Bacheburg from Stanford whose a world class epidemiologist, did a very very interesting study. In the states that have medical cannabis laws, and you can look, I can cite you the article, and the date is August 2015 or 16, in the states that have medical cannabis laws, there was a 40% reduction in opioid prescription deaths since those laws were enacted. And why is that? Why is that? It’s not a coincidence because they’ve continued that study, and that data has only been strengthened. And then I was involved in the largest study in the United States at the time. We looked at 2,000 patients, two thousand patients, who had a 40% reduction in alcohol use, opioid use, and sedative hypnotic use, sleep aids, because of medical cannabis. And that was in the Journal of Psychopathology in 2017.
I’m telling you I could go on and bore you all day with data. Now, I know what you’re saying, you want randomized controlled studies for dosage. That doesn’t exist. That does not exist. Those studies are not done. The Cochrane data base, which is a huge body of metanalysis, which are studies that study studies, ok? In other words, review papers that look at studies. Cochrane data base has huge amounts of data looking at 2,000 studies for example on certain segments, certain diseases. And I could certainly reference those for you as well.
Dr. Schreck: I’d be interested in looking at the numbers showing 40% reduction in deaths –
Dr. Burchman: Oh, well I wrote that study, so I happened to give you a copy.
Dr. Schreck: But I appreciate the information. If you could give me information that I have not been able to find myself or obtain from anybody else. If we could have a chance to talk about it afterwards, I would appreciate it.
Dr. Burchman: Absolutely. Well, I really appreciate your time and I appreciate the opportunity to hopefully open your eyes a little bit.
Owen Parker: Uh, Lucas, do you have a powerpoint version of your presentation?
Lucas Nelson: Uh, yeah.
Moderator: So for everybody in the audience, item b there on uh, 6, Lucas Nelson from MedPharm Iowa is gonna go just a little bit later when he also presents when he also presents on item 8, and we’ll combine everything there. Alright, so we’re at item 7, the program update and review, THC purchasing data with Owen Parker. He is the program manager for the office of medical cannabidiol and he is here today to provide a program update. Owen?
(68 minute mark)
Owen Parker: Thank you. Alright everybody, let me get this out of the way here. Did we just lose it?
Carl: Your screen went black too.
Owen: Ok. So usually I give you an update on the, these are the program metrics, some of the things that are important. I think everybody has seen plenty of those at this point. We just released our annual report. So what I wanted to do is discuss things a little more pressing. As the year ended of the program, we do have the granular THC purchasing data, at this point. Something that’s also very important is that we are at year end. A lot of patient cards are expiring, so we want to track, you know, how fast that we’re doing, are they renewing, what percentage of them are renewing.
So, this is a little bit of what we’ll cover. Some THC purchasing patterns, the one important thing is how do we actually track this granular level? Uh, some of the purchasing product that we’ve seen across the program, but also some considerations that are important to our patient population. Um, so the transient averages for those purchasers, and then there attributes.
Actually this is – I won’t cover the proposed legislation. Sarah will be covering that. Um, I will just go from there.
Uh, so this is how we track THC in the system at least uh, in general. So, part of testing, every manufacturer has to make a label plan. They have to tell us exactly how much THC is gonna be in their product. The lab tests against that label claim. So then we load those queues with those THC amounts into our system, we have real time access to all dispensary sales. Our dispensaries must reconcile that inventory each week. So we do have very granular views of how patients are purchasing THC.
So this is a little bit about what we’ve seen. The program to date, is again, part of those conception, Iowa does not have a cap on THC, patients can really purchase as much as they can afford I mean we’ve covered that. But at this point there’s been one hundred and thirty-two individual patients that have purchased more than four-and-a-half grams of THC in any ninety day period, so we can track after the time they purchase, so we can basically create a ninety day period out of any transaction.
Amongst these patients, the average THC has been eight-point-one (8.1) grams purchased amongst those one hundred and thirty-two individuals. Ninety-six percent of these patients are certified for untreatable pain. As we kind of discussed, just over seventy percent of all the patients in Iowa are also certified for that condition.
So some of the considerations for this. Iowa certainly has a very pride sensitive patient population. Also we only have five dispensaries, we’re a very rural state. We’ve gone back and looked at some of these higher purchasers, and many of the are traveling multiple hours to a dispensary. They really only come every three to six months. So they’re not really people that are purchasing, you know, every two weeks, or every three weeks. Other people that are making a long drive and they’re purchasing a lot at one time. So one of the considerations for that was with a lower bound, patients would probably need to travel more often.
Prices, you know, it’s important to compare prices in similar markets. Our prices are competitively priced with Minnesota’s program. They are about the same price. A lot of (?) have significant costs incurred by patients. You’ve heard mixed reports that sometimes that consultation fee is covered, sometimes it is not. There’s obviously the one hundred dollar, or twenty-five dollar, application fee, there’s travel costs. The price of products without any of those cheaper bounds, or ah, you know cheaper product forms, patients do pay, you know, more than they may just in other states just because of a lack of those options. (one hour twelve minutes mark) And again, 40% of our patients qualify for that reduced fee. So either Medicaid or disability.
So with these factors that we’ve gone back and looked at these patients, it’s certainly possible that many of them are purchasing based on budget as opposed to efficacy.
So this is what we have actually seen in the program to date. (?) these patients. You see that these would be obviously more than one thirty-two if you add them up. These are just, these could be repeat patients. We didn’t do individuals with this. But since the program launched, we’ve been ah, this is something we’ve been tracking for the state, is the number of people that have surpassed four and a half grams in any given month, as well as the average amongst those patients. As you can really see that over time as our patient population has continued to grow, this number has really kind of gone linearly right with that. And this is just something that, in all reality, we will continue to see, especially as, again I’m, with the intent of the program, I can understand, but in reality that would kind of turn down because the patients have kind of gotten accustomed to this.
In terms of attributes, kind of as Dr. Bergman mentioned, you know the fastest expanding demographic category that I’ve also mentioned to you, are people in that 50 to 70 age group. Really these four and a half gram purchasers, there’s really no, anything specifically about them by any means. It’s really pretty broadly distributed. But nearly half of them are between the age range of 50 to 70 years old.
So this is one of the things that I mentioned again. Basically moving forward this is going to be our primary metric for program health. You know it’s really, it’s one thing to have, patients join the program, it really speaks to the efficacy if they actually stay. So uh, we’ve been tracking this. This will obviously take time to mature. Obviously we’re just getting to the point where many of those cards are expiring. But at this point 68% of our patients have not renewed. We’ve gone back and looked at that, and actually half of that 68% only made one purchase, or no purchases. So those are people who might have came, didn’t see what they wanted or it didn’t work for them, or they didn’t come back. This percentage here is something that we’re really going to watch for, the people that have renewed before they expire. Those are obviously people that are finding it very efficacious. They don’t even want any lag time between when their card expires, and when they can purchase more product. But in general, this is what we’re going to be tracking to find out, you know, is the program working for patients, because obviously if it was working, they would stay.
I meant to take these out. Sarah will cover these. But one of the last things I wanted to discuss with you was a petition that we discussed in August that Carl had submitted um for the Department to seek an exemption from the DEA. We do understand that this is, you know, there’s obvious conflicts between federal and state law. But to our knowledge no states have moved forward with this. The most likely reason for this is in 2013 Barack Obama passed the Cole Memo, which restricted (?) for state programs. It was in the (?) in 2014. That did expire in September, so technically Carl is correct that the US Attorneys could do something if they really wanted to, but at the same time, we’re not familiar with anything that’s ever happened to any of these states. You have the state banking act that is moving through, which would help. So, they’re really going the opposite way, they’re not really looking to punish states that are operating their programs legally, especially medical ones.
So, at this time, we have declined to submit that request to the DEA. That’s really where I wanted to leave it. I really kind of wanted to keep it brief if there was any other discussion. I just wanted to provide you with some objective data with what our seed-to-sale system is actually telling us about the patients that are purchasing THC. Are there any questions? Yeah, sure.
Dr. Stoken: What’s the total number of patients on the program?
Owen: Uh, we’re, it’s uh, about 5200 or so, if Doug is here.
Doug: It’s about right.
Owen: I don’t have it right in front of me.
Dr Schreck: Um, I kinda thought. There are 5200 patients. There are a hundred and thirty some –
Owen: Individuals.
Dr. Schreck: — individuals who are currently purchasing more than 4.5 grams?
Owen: Correct.
Dr. Schreck: So, if we were to come in and kind of change the law that would make it difficult for those one hundred and thirty-two people?
Owen: Um, yes, yes —
Dr. Stoker: They could be recertified.
Owen: Yeah. They would either have to go back, go to their provider, you know, to have that limit waived for them, um.
Dr. Schreck: Yeah. And that’s part of my point. It’s a hundred and thirty-two people, and I look at the Minnesota data and they talked about thousands. At least that’s not Iowa.
Owen: Yeah, Minnesota has about 20,000 patients, we have about 25% of the patients that they do. Their program is four years old.
Sarah Reisetter: You can go.
Dr. Schreck: Just to clarify, uh, I guess I read this, but I’m not sure I understand it. Can you enlarge on why it is that the Department of Health doesn’t want to, chose not to back up Mr. Olsen’s request?
Owen: Of the what?
Dr. Schreck: Voting to petition the DEA.
Owen: Um. You know, really, it is um, the way I think about this is, you know, Jeff Sessions was one of those Attorney Generals that was a drug warrior, he did rescind that Cole Memo. He is not there anymore. We’ve really just seen the progression of this go towards the opposite. You know, they’re trying to provide more research. They’re trying to provide safe banking services. They do understand this is something they need to reconcile. You know, in the last four months, we’ve had the first stand alone bills to ever make it through, you know, a chamber of the US Congress. So really, this is a, this has been a problem that has been obvious, you know, for twenty-three years. They’ve done all kinds of, you know, things to kind of protect it along the way, and now we’re at the point where, you know, there may be a gap the Rohrabacher amendment expiring. But at the same time again, there’s these other legislative movements, they’re trying to solve this, and there’s really nobody that is actively going after states, especially small ones like Iowa that have only been doing this for a year. So we really just see the risk, you know, as being low, and we really think there’s other states that, you know, this is a lot bigger part of what they do, um, that will probably move it forward.
Dr. Schreck: You know, I’ve had a hard time myself with understanding what Mr. Olsen has proposed. But he points out there is already an example of this thing done, which is peyote. And it’s a Schedule I substance, and (?) dispensation from the feds that that’s allowable under certain circumstances. I also get the impression, and he’s sitting right there so he can correct me, he’s offended by the idea that we’re all breaking federal law.
Owen: Yeah, I –
Dr. Schreck: So, if there’s a way to not break the law, let’s not break the law. Seemed to me to be a simple thing for the Department to do. But I think a couple of the bills that are in the Legislature are going to require you to do that if passed.
Owen: Yeah, for certain, yes. For certain, you know, we will have to have to figure out, you know, how to do that. Ah, but again, I certainly understand, you know, the issue, um, but we’re not familiar with another state that has moved forward with that. And if no one has done that, having this problem for a lot longer period of time, in terms of the risk, right, remember, we’re always going to gauge those things. Combined with the protections that were in effect, you know, for the last six years, that just ended, you know we really think that any risk of this is low, and probably likely to (one hour twenty-minute mark)
Dr. Schreck: Well, and I would agree with that, but in the meantime, we’re all breaking the law, and it seems like a simple thing to do. Um, we passed on it with verbal approval but on a vote, so you really are going to the Department of Health. And uh, meanwhile we’re just going to have to wait, and see. I think we hear what he wants. It makes sense initially. I hope we are both around to see it. He is a very dedicated and committed.
Owen: I know. He is.
Sarah Reisetter: Dr. Schreck, the records for response to Carl’s petition for agency action to the Department of Health (unintelligible).
Carl Olsen: Yeah. When you read that, I address it. Thank you.
John Fenner: I happen to be one of the 5200 people that has been a patient. I’m also one of the patients of the 132 that have bought more than 4.6. And I am also sixty eight percent that I didn’t go back, and I will won’t redo my card. At this point it’s useless, there’s no quality, there’s no, it doesn’t work.
Moderator: Dr. Schreck?
Dr. Schreck: Um. I sympathize with that. With the current three percent cap, you can buy as much as you want.
John: Yeah.
Dr. Schreck: Now at some point, it’s a lot of money. And that’s, I’m not sure anything is going to solve that problem. This is going to be sold by the milligram per THC basically. It’s the way it’s done in Minnesota, that’s the way our govern – it’s one of our manufacturers, they pretty much set it up the same way. So it’s gonna be a, to get the larger amount, you’re going to have to pay more money. If you pay more money, you can get it right now. We think that’s going to change. That three percent is going to change. Just some other, mechanism. Just a suggestion. It’s a lot of money, it’s out of pocket, it’s not covered by insurance, and right now it’s cash.
Off screen: I’m a card holder, I’d be a hundred and thirty-three people, but I can’t afford to buy that much a week.
Dr. Schreck: Right. I’m not sure the cost is going to change no matter what we put on a limiting cap. Cost is still going to be milligram –
Off-screen: But isn’t a lot of the cost the taking the THC out of the product?
Moderator: We need to kind of move on here because we’re getting off topic.
Shelly: If we could change the strains, and add in terpenes, that could more effectively treat pain. That would change this.
Moderator: Well we’re gonna move on to item eight here, ok? Lucas, (unintelligible). (One hour twenty-five-minute mark). Ok we’re at item eight, MedPharm THC data and purchase cap presentation. We have Lucas Nelson General Manager of MedPharm Iowa, is here today to provide information on THC purchase data. Lucas, thank you for your patience.
Lucas Nelson: No problem, thank you guys.
Perfect. If you will, you can even go to the next one and it will start right there. Great.
Well, thank you for the opportunity to discuss THC levels today. We’d like to quickly recap other states purchasing caps and then show you some data that we’ve compiled. We would then like to offer a compromise that I feel confident the Legislature will accept provided that this board and the other licensees are able to demonstrate to the Legislature strong support for this compromise. I would note at the outset that based on, at least our conversations with lawmakers, a statement in the minutes even of this compromise I think would be enough for them to insert it into legislation.
And also, in giving up our licensee update time, hopeful that you won’t feel rushed and engage in some thoughtful discussion during this time. To that I’d like to try to leave time available at the end for some discussion and I’ve also brought Rebecca along for that as well.
So I’ll start by reviewing the data provided by IDPH in 2019 as a reminder of where Iowa is right now and where we may fall. As you’ll recall, there’s no purchase limit under our current program. Once in the program, for up to an entire year, a patient is limited as Dr. Schreck pointed out, only by the funds he or she may have access to. Proposed legislation last year and this year would still make Iowa the most conservative state in the country as far as THC purchase caps. The proposal from this board would also make us the most conservative by more than a fifth of the next largest state limit.
I think it’s safe to say that any legislation passed in this state will take us from an uncapped program today to the most conservative in the country regardless of where that final number might fall.
I’d now like to show you, if Owen, if you could move on to the next one. The THC purchase data we’ve shared with lawmakers, especially as it relates to a potential effect on patients. You’ve already heard Owen sort of explain this column then. Um, the state’s data on actual purchases, and of course while we agree that that is accurate data, it’s not our opinion that purchases alone take into account the full picture, and Owen even alluded to that. We think that it is vital that we establish policy not based on financial, or geographical, or other limitations patients may face. Instead we should establish policy based on both science and compassion.
The data in the middle column is from MedPharm. This is from our real experiences in our two dispensaries with real Iowa patients. These are the people we interact with every single day; our staff is doing it right this very moment, and it is caring for them that has driven our entire business. It was the whole purpose we decided to apply for this license in the first place.
While a patient may have been able to reach his or her proper dose at some point, it’s our experience that few patients are actually able to sustain that ideal dose. So, as you can see, that’s what our column there in yellow in the middle are based on. How did we actually arrive at what we feel is those proper doses for our patients? We’ve used a number of different actual data points based on again those actual experiences in the dispensary, and our knowledge of our patients’ habits. For some, we have journals that describe each dose taken. Benefits, side effects, what level relief was, or wasn’t achieved. We also have six-month surveys that focus on these same topics. From this data based on those actual interactions, we’re able to calculate our patients’ ideal dose, even if that patient isn’t able to sustain it. And you’ve already heard Acres discuss that exact point, that a number of different patients really do fall in a range of different doses. We then took those ideal doses and extrapolated them across ninety days and compared to them proposed purchase limits there on the far left.
Owen’s already discussed a little bit, but why might a patient not actually be able to reach his or her proper dose? Cost is that number one factor. Factors contributing to high cost of products include among other things, extremely high laboratory testing costs, high licensing fees, the three percent formulation cap, which obviously adds cost unnecessarily, it prevents certain forms from being manufactured, and then of course the relatively low number of patients. The high cost is compounded by the financial situation many patients face. Again, Owen alluded to that. About 40% of them qualify for that reduced fee. And then of course the relatively few dispensaries which means patients are driving long distances for their medicine which also contributes to them not necessarily purchasing exactly to their dose.
However, what we wanted to do was make sure that our columns there actually make sense and were reasonable. And in order to confirm that our dose numbers were realistic, we compared them to a program that is the most similar to ours, Minnesota’s medical cannabis program. As you guys know, Minnesota has similar eligible conditions, and perhaps the most critically, does not allow whole plant access. (One hour thirty-one-minute mark).
When we reviewed Minnesota’s published data on it’s program, and their reported doses, which I must emphasize while I can appreciate the point Dr. Schreck made earlier about it being a sales report, I must emphasize that those doses in Minnesota are determined by medical professionals. In Minnesota’s case, pharmacists. As you can see, a four-and-a-half-gram cap in Minnesota would cut out more than 60% of the patients. Again, those patients were dosed by pharmacists.
As you can see Minnesota’s data actually trends a bit higher than Iowa’s. If we make the reforms as we’ve discussed over the past year, removal of that formulation cap, adding PTSD as a condition, etcetera, I believe we’ll have a program pretty similar to Minnesota, which would likely result in a similar demand for THC, and would also result in the related effects as you can see for various related purchase caps may have on Iowa patients.
So now, for MedPharm’s proposed compromise. I’ve personally listened to this Board’s thoughts and opinions since it was formed in 2017. Above all else, it is at least my opinion, and MedPharm’s opinion, that this Board has been clamoring and yearning for more provider involvement in Iowa’s medical cannabis program. To that end, late in 2019, this Board recommended a purchase cap of four-and-a-half-grams of THC over ninety days, but importantly, as Dr. Stoker pointed out earlier, it also recommended that providers be permitted to dose a patient up to, theoretically, any amount of THC, which essentially could become an unlimited amount.
I believe the Board was taking two positions with that recommendation. One, an implicit acknowledgment that certain patients may need more than that four-and-a-half grams of over ninety days, and second, that this Board wanted providers more involved in the process. As you probably are aware, the Controlled Substances Act prohibits provider dosing, as proposed by the Board. Settled law from the early 2000’s and the 9th Circuit Court established that providers could discuss medical cannabis with their patients, dosing is prohibited per the CSA. So with the Board’s recommendation and with the Controlled Substances Act as a backdrop, MedPharm went to work brainstorming ways to provide effective purchase limits, while legally providing more provider involvement.
Our proposed compromise, which I had the privilege of sharing with Dr. Miller during his visit to our facilities last week, is to set a purchase limit of seventeen grams of THC per ninety days, while also providing the ability for providers to decertify patients from the program. Allow me to explain this a bit further.
First, the purchase limit is enforced at the dispensary level. This limit provides a hard cap that dispensaries must comply with, one that does not exist today. IDPH’s seed-to-sale tracking system can track this across all dispensaries, so that we can ensure that the system is not abused.
I believe seventeen grams is a strong compromise. It balances the Governor’s concern that the twenty-five gram cap was too much. It ensures that we are transformed into the most conservative state in the country, as far as purchasing limits are concerned, but most importantly, it allows dispensaries to treat more than ninety-seven percent of current Iowa patients who would be able to reach that proper dose.
Even if Minnesota, where pharmacists, again, establish doses, such a limit would allow treatment of more than ninety-five percent of Minnesota patients.
It’s key to remember that we’re no longer at the start of our medical cannabis program. We’re in fact more than a year into it. Even if it was only one patient, it will be absolutely heartbreaking to establish a policy that forces a patient to reduce his or her dose. While unfortunately this proposed limit of seventeen grams would force patients to indeed reduce their doses, afforded it just is a part of this compromise. Now this compromise works in tandem with the second aspect we support: provider decertification. As previously mentioned, we believe that this Board has been saying for years that it wants providers more involved in the process, so we believe this can be legally accomplished for decertification. Decertification is simple enough. For any patient, his or her provider would have the ability to decertify the patient from the program. This may be, because, for example, medicine is not effective. Maybe there’s suspected abuse. Or simply in the provider’s opinion, the patient purchased too much THC.
If a provider decertified a patient, the patient would be required to return the product within a short amount of time to any of the dispensaries, and would be prohibited from buying products unless he or she became a patient again. To prevent doctor shopping we would recommend that a patient could only be certified twice in a one year period. That initial one, then perhaps one recertification.
I must note that our situation is somewhat outside the norm for medicine. I know a few instances if any where a Board or the Legislature even essentially regulates what medicine a patient takes or how much. The FDA of course, does not do this. If the Board’s recommendation on requiring pharmacists to work in dispensaries becomes law, it may become especially strange, since pharmacists would essentially be limited in their ability to properly dose patients. However, I do believe that in the face of the Controlled Substances Act, providing for decertification is indeed the best option we have. If you’d like to see it on paper, please review senate study bill 3136.
Please recognize that this proposal moves us from one checkpoint in the program, which is certification, to at least three. Certification, dispensary limit of seventeen grams, and perhaps most importantly, provider decertification.
And right off the bat let me address a few current concerns Dr. Miller raised in our discussion. How would a provider know how much a patient had been buying? We thought it made the most sense for this data to be provided directly into the pmp to make it as easy as possible to review. I have no doubt that the state’s robust tracking system build on Sales Force can accomplish that.
What if a provider isn’t sure whether two grams or twelve grams is the right number when the provider sees that number on the screen? It’s our bet, it’s our hope, that this facilitates a discussion between the provider and the patient. What’s going on? Is medical cannabis not working? Are you building up your dose? Has something changed in your day to day routine? Have you decreased opioids but increased medical cannabis? The beauty of this proposal in our eyes is that both the patient and provider are encouraged to have more ongoing conversations than they are now. Again, providing that level of involvement with the provider that is not facilitated in our current program.
I believe it’s fair to say, and perhaps today’s discussion demonstrated that, that at times in the past various scientific research and this Board have disagreed somewhat on proper THC dosing. I think it’s fair to estimate that there are other opinions from the nearly thousand Iowa providers who have certified a patient. I think pharmacists dosing in Minnesota would have yet another interpretation.
All of this well-intentioned disagreement and these different interpretations, I think, demonstrate the usefulness of establishing some limit at the dispensary level, while providing, legally, flexibility for providers from patient to patient. This is the same concept that permeates medicine in the United States, with a bit of a twist to account for the CSA.
I must agree with Dr. Miller’s comments about the Legislature’s desire to have a compromise reach between this Board and it’s licensees, who are the ones again face to face with those patients every day. It’s our opinion that a compromise that both this Board and the licensees support, will likely win quick favor with the Legislature, and such a compromise can ensure that meaningful legislation is indeed passed in 2020 that benefits all stakeholders in our program.
So today, I am asking for a statement of support, by this Board, for this compromise. Seventeen grams of THC per ninety days along with doctor decertification. And for that statement to be inserted into the minutes for this meeting. I’ll take any questions you all have.
Dr. Schreck: Um. What’s illegal? What, what can’t – you mentioned the CSA. What can a doctor not do?
Lucas: So, exactly. So there’s a case from the 9th Circuit Court, Conant v. Walters, that was decided in conjunction with California’s medical cannabis program, and it was settled by the 9th Circuit in the early 2000’s. And what it established was that patients, or excuse me, providers, have a specific actual First Amendment right, to discuss medical cannabis with their patients. They do not, however, have the ability to dose patients up because that is prohibited under the Controlled Substances Act. It’s our fear, it’s our belief, as well, that the recommendation that came from the Board that Dr. Stoken mentioned earlier about providers being able to dose a particular patient up, would in fact bump up against that Controlled Substances Act and would perhaps make that illegal. And so, when we looked at it, ok, if we know that that’s illegal, what else can we do to hopefully address the exact same concerns, in again, a legal way.
Dr. Schreck: The case you cited in California, 2001, that was federal court, right?
Lucas: It was, yes.
Dr. Schreck: It was under federal law.
Lucas: Yes, the Controlled Substances Act –
Dr. Schreck: Which we know federal law is not being enforced.
Lucas: It may not be being enforced at every single level, that’s fair.
Dr. Schreck: And somebody may find out that somewhere along the way, somebody said you can’t do that. Currently, I have sat with doctors’ practices. I see no problem with doing that. The doctors that are – in fact let me read – the Board is trying to keep us, what I would call compassionate, and yet maintain a footing in medical science. As recommended, two exceptions to the four-point five gram limit. One was actually in House File 732 last year. It’s not there now but we’re gonna try to get it there. And that is if you don’t have long to live. If you’re a hospice patient, or maybe you’ve never met, if you can get your doctor to just certify you have one year to live or less, the best, the doctor’s best opinion. All bets are off. Buy as much THC as they want. That’s the bill last year, which we supported that, we liked that bill. In an effort to make this more flexible and more compassionate, we have also recommended, and this came from the board, the terminal illness feature and the grams per ninety days, actually came from the Legislature or maybe, industry or somehow, it was an improvement on what the Board could think of, that’s for sure. But we’ve gone a step further. The Board recommends that certified healthcare practitioners be able to certify any other patient for a higher THC purchase limit if, after participating in the program, under the four point five gram THC purchase limit, the patient and certified healthcare provider, agree that four point five grams of THC over ninety days is not a sufficient amount of THC to treat the patient with a debilitating medical condition. So anybody can walk in the door and say to their doctor, it’s not working, I want to be an exception. You can do that. That’s our recommendation. We recommended that last summer. We agree to enforce that, or excuse me, we recommend at our meeting on November 1st. It’s already been discussed with legislators. Now, your idea of coming around the other way, and giving everybody a higher amount right up front, it can only have it taken away. I’ll use the example of Miss Lucas, your expression. It’s a lot easier to beg for forgiveness than it is to ask permission. Much easier. We all know that. That’s how we deal with our parents, that’s how we deal with our peers, it’s much easier. But it’s not the way to control what’s given out. Much more efficient to get the doctor involved up front, right on the spot, so there’s a discussion between the doctor and the patient right away. In going over this medical support of a cap. Now, I think that offers more of a sense of infinite flexibility. The doctor is not going is not going to prescribe that amount. He may discuss it with a patient as time goes on. But he’s not going to prescribe the amount to her. He’s just going to free them from that four-point-five grams cap. That will force the Department as I see it to issue two different kinds of cards. A standard card of four-point-five which everybody comes in on, and a subsequent card for any amount that the patient wants to buy. Yet it introduces tremendous flexibility, it does the same thing that you said was a laudable goal, it involves the physician in the discussion. I don’t think that physicians are going to be real happy about this because they don’t know a whole lot about this, but it will force them to learn. So I would disagree with your backdoor approach and I would do it right up front. I’m not sure that anybody is aware or regular people are aware that the Board had made this recommendation. In fact, it’s not in the current House Study Bill, six whatever it is, to try to get it in there. In fact I think we’ll have real trouble getting it in there. To allow flexibility, and also, quite frankly, to help with something that the government will be able to sign. We need that, we need that there. And there’s a series of compromises here. As an oncologist, I can tell you that we compromise very easily for the truly ill patient. Number one, they’re not going to live long after developing problems. Not going to live long and have to get uh, cannabis use disorder. Um, there’s also a compassionate psychological effect here. It’s bad enough when somebody tells you you have to go to the nursing home and you don’t want to go to the nursing home, but they have to do it anyway, and you try not to do that. It’s also bad not to do but try what you think what might help you, and nobody allows you to do it. With all the publicity and all the hype involved with medical cannabis, that truly ill patient can go and buy as much as they want. And they can describe for themselves if it’s really helpful.
As far as the other category of patients, since there’s no medical evidence I’ve seen from you folks, (unintelligible) from our guest physician today, no medical evidence whatsoever that higher doses are being studied. I don’t think there are any practicing physicians who are going to be enthusiastic about providing that admission to their patient, but they certainly can’t. I think it would be a rare circumstance for it if it were going to be done. You will still maintain good control of your not THC in our streets, our homes, and our place in our society. I may be wrong about that, maybe the default follows everybody (??). But then we’ll find out. We’ll find out about that. So we will do our best to get those two exceptions in House study bill, and make this a more flexible program hopefully the government will sign.
Lucas: I’ll say, just in, there’s a lot there, make sure I catch it, but hopefully some of it at least. You guys, you all are aware of my expertise is, is in law, not in, in the medical profession. I keep people like Rebecca around to help with that. To your first, your very first point about the violations of federal law. I believe, it’s my opinion, that the reason the federal government has stayed away from all of these states, from more than thirty states at this point, is because they’ve established that we have very tight programs in most cases, and have not to my knowledge, any state that has actually gone with any sort of provider dosing. Again, something that there is specific case law out there about. Maybe it wouldn’t happen, that we would be the first ones to be called out for that, that something would happen. I don’t know that it’s something that patients, providers, or licensees are going to want to be willing to risk. That’s another step in what we’ve seen across the country. So, it’s perhaps unknowable, but I do think that providers, bumping up against anything that resembles dosing puts our state in a more precarious position than it’s in now. And to your point Dr. Schreck about if we set a gram limit of seventeen, for instance like we have suggested today, that all of a sudden there will be this rush out to buy it, I respectfully disagree with that. Again, it’s unlimited right now, it has been for more than a year, we have not seen or have reports of abuse of people running out and buying an excessive amount that they didn’t need. Saw some of that data, uh, in my opinion backed up by what Owen presented, um, and you know, I know there’s a recommendation to take the DOT out. I certainly don’t mean to disparage the DOT by any means but, you know a two-card system, I don’t know if that injects more uncertainty, if that injects more complexity. This is already a difficult program, it’s already difficult to navigate. Again, our patient population is such that we’ve spent days, weeks, months, years with them. It is not easy to get into this program necessarily. It is not easy to understand all the various things you have to do. I’m glad that the Legislature is looking at that and trying to improve that, but I do fear that in explaining to patients, OK, well here’s the process for doing this, here’s a form you need to fill out. You know, you all are some of the more involved medical professionals in the state, we travel around to small towns in Iowa, we travel to big program, or big providers, big hospitals here in Des Moines. That are confused about this process. That don’t understand, how does this work? Where am I protected? What am I not protected for? Where is my risk? All of those things I think those risks, those issues are just going to increase by adding these additional layers of complexity. That’s why we tried to come up with a solution that addressed the concerns, simple to understand, simple to implement for the state, it’s simple to enforce. And again that is where we were coming from with our proposal.
Rebecca Lucas: And, that used medical and professional data. So I think, one of the things, to echo Lucas, is Minnesota is yes it’s an uncapped program, however, they have medical professionals dosing. If we think that no cap will cause people to take 1,000, 2,000, 3,000 milligrams, we actually don’t see that in practice. With Minnesota being uncapped, if we were to take the viewpoint that now everyone is going to go crazy and buy as much THC as possible, we don’t see that anywhere realistically. We don’t see everyone taking 25, or everyone taking 20, or everyone taking 40 in Minnesota’s program. So, by setting a cap that also is accorded by the medical professionals that dose in Minnesota, I think we will see that dose curve just like Dr. Burchman talked about.
Moderator: Any other questions from the Board?
Dr. Schreck: Dr. Miller, are you still there?
Dr. Miller: I am.
Dr. Schreck: Alright. Correct me if I must scream. Dr. Miller and I were both invited by the Governor, last May, whenever it was, two days before she drew up the bill, to come and talk to her. The first question she asked us is, how much can we compromise here? And before I could open my very busy mouth, (unintelligible). He wanted 2.7 grams be the limit, because that’s 30 milligrams a day. In which, I can’t find the study (feed cuts out). We compromised within ourselves at the time, 4.5 milligrams, or 4.5 grams per ninety days, but that’s 50 milligrams per day. How did we do that? Well, if somebody’s already sick, or different sized patients, or patients with inefficient application of the medicine, and so forth. So we raised the dose by 66.6%, which would be a medically justified dose, as a compromise. There was already a compromise there. Yeah, at that point, any, all discussion of compromises (?). So uh, I can’t change what medical science does. I can’t make it up. I can’t do it in my practice, my practice being cancer patients, I can’t say something different to what the medical literature said. It speaks to us. It speaks to us. And at 2.7, and we’ve already compassionately gone to 4.5. Is this too much? We knew it would be hard on some patients to cut back admittedly. It’ll be harder a year from now, harder five years from now. Just going to be more and more patients.
(one hour fifty-one minute mark)
Lucas: Uh, and I think I will refer you to Rebecca, and to Dr. Burchman, and their statements. He summed it up quite perfectly that, at least he disagrees with some of that that’s out there, and there, you know, the interpretations that he’s seen, that Rebecca’s seen, that this Board has, that Minnesota has, again those doctors that are certified across our state. And again, I would direct you right back to my point that that disagreement I think is well-intentioned, I don’t think anyone is out here with nefarious intent, but at the same point, that’s why we’ve come up with something that makes sure we capture all of those patients, but also it puts a limit at some point, and we say, there’s a point where enough is enough, and give another checkpoint to those providers. You are the ones having hopefully those conversations that are in there understanding with the patients what’s going on that allows them to get them removed from the program. And that’s something that we’ve heard from physicians just beyond this Board, the desire for some sort of mechanism there. Because there isn’t one right now. And if it’s unchecked and for that year, who knows what could happen?
Dr. Schreck: The uh, the number you gave us of Iowa patients who would be affected by 4.5 cap was one hundred and thirty so. The number on your site was more than twice that.
Rebecca: Yeah, sorry –
Owen: I did explain that. So with our conversation, there were 132 individuals, is with a 90 day period attached to it. (Hard to hear rest)
Dr. Schreck: Got you.
Moderator: I just have one question. So, when we’re talking about a cap, is there any data on tolerance? So, patients having to increase the amount of THC they intake to get the same effect? We set a cap at 17, a year from now, we’re gonna hear 17 is too low, we gotta raise that. How quickly do these patients –
Rebecca: Yeah, I can take on that question. And actually, the paper that you all cited last year, Russo’s paper, that looks at Canadian patients. They say that, this (?), but one to three grams is what patients are usually taking per day. Now what he also explains in that paper is that while you see a tolerance to the side effects of cannabis, there isn’t tolerance to the medical benefits, once people are at their maintenance dose. There’s a couple other studies out there that show that once people get to their maintenance dose that’s basically where they stay, and I think that paper went out three years. Of course we have degenerative conditions, where the dose will probably go up as the degeneration keeps happening with that condition, but on the whole, we see people go up for maintenance dose, and stay there. Unlike, for example, opioids, where we see a stair-step process, where you find that their tolerance is where you’re not really seeing any benefit anymore.
Dr. Schreck: And I will point out, and I hate to be stuck on the medical literature. Sorry to be stuck on it. We are only one voice. We are an advisory Board. We don’t decide what to do. We advise the Legislature, who created us. And hopefully along the way, are educating patients, and especially physicians, what’s going on and what’s happening, and I’m sure some people will look back at this as an unsettled time, not just in Washington but here.
Lucas: Sure.
Dr. Schreck: And, we’ll uh, have it perfected and set up. But as the Governor herself said, it’s a new program, and we should proceed slowly. And I don’t think there’s anything wrong with being the only state that follows what medical science says. We’ll be the rational state, even if it makes us an outlier.
Lucas: I would argue that’s exactly what we’re proposing and trying to do. Again, moving from more, from less checkpoints to more, providing to my knowledge maybe the only legal means to allow for some sort of required (?), some sort of more involvement from, from providers. It’s a challenging situation, but the better we can do for patients is the only thing that MedPharm, that I care about, that Rebecca cares about.
John Fenner: Why is what we are trying to do reinvent the wheel? Other states have done this and gone through this. You’re, you’re saying –
Moderator: We have to keep moving on sir.
John Fenner: You’re saying after one year –
Moderator: Sir. Sir.
John Fenner: I’ll leave after this if you want me to. You say, if that’s how we’re going to handle it, and I can get –
Moderator: — we don’t have time for a back and forth from the audience.
John Fenner: You guys were wanting to take this thing and delay it, and all you are doing is punishing us. I’ll leave. Do you want me to leave?
Moderator: Ok. Sarah, would you like to lead the discussion regarding the Board of Medicine’s decision on the autism condition and the petition process with the Board of Medicine in general?
Sarah: Ok. So, this is on the agenda because, as you know, this Board recommended a number of different conditions to the Board of Medicine, and they’re actually on those as, you know, some of them have been approved, others have been denied. So, you approved pediatric autism, for self-injurious or aggressive behaviors, that was adopted by the Board of Medicine and presented by the advisory board.
Um, then you also approved severe intractable autism with self-injurious or aggressive behavior, I think under the, in an effort to enroll in the adult population as well. Um, the Board of Medicine in the form of a notice of intended action on that particular rule, but then did not move forward with adopting that particular condition. (One hour fifty-seven minutes) And my understanding of the reason, and Owen can chime on this one too, he was at the meeting when this happened but, um, the Board of Medicine I think is struggling with concept of refractory nature of some of these conditions, and so, they have um, you know, as part of their discussion, they would like to amend the condition that had been recommended to be severe autism with intractable irritability and aggression refractory to apply behavioral analysis and for being an acceptable standard of pharmacological treatments. The Board doesn’t have the authority under the statute to amend your recommendations, and so I think that’s why we really wanted to have the conversation with you kind of about the process. It was alluded to earlier, one of the things that we want to avoid if at all possible, is petitions bouncing between this, you know, your board, and the Board of Medicine. So I know Owen has had some conversations with staff from the Board of Medicine, and I think they may come up with a conceptual way for the two boards to communicate more proactively in advance of this Board’s consideration of the petition at the outset. So Owen, I don’t know if you want to just kind of explain a little bit of what you and Joelfrom the Board of Medicine have talked about as maybe, a way to bring the Board of Medicine in a little bit earlier in terms of that partnership.
Owen: So yeah, I had a talk with Joel, Joel is here, talked to the Board of Medicine. (quiet and hard to transcribe here plus I’m tired)
Sarah Reisetter: Yeah I think that, one of those – I think that conceptually what has been discussed is that the Board of Medicine might move to put up some language in their rules. So if you remember, the statute says that, you know, you make your recommendation to the Board of Medicine, they put it into their rules to the extent that new conditions are added, that um, and and Joel can correct me if I’m wrong when I’m finished. But I think that the the, what has been discussed has been that the Board of Medicine might just add some language to that, to their own rules to kind of discuss this concept of, of refractory. Um, and, so, I think that, I think, that’s one way of saying, that I think we can address, cause some of the Board of Medicine’s concerns, um, and Joel, I don’t know if you want to, if you have anything else that you’d like to add to the conversation.
Joel: Right. I think –
Sarah: I’m sorry Joel. Why don’t you go ahead and introduce yourself?
Joel: Sure. High, I’m Joel Carolyn, legal rep for the Board of Medicine. Um, so Sarah got it right basically. In looking at our rules governing standards of practice, um, for prescribing medical cannabidiol. Um, we, I think we sort of reached, what the Board of Medicine saw as, the sticking point, which was that these uh, as added by this Board, the conditions that this Board approves, uh, the treatment as administered by the Board of Medicine, um, uh, is that, they should be refractory, uh, to, except for both, and standard treatments for those conditions that already exist. So, rather than, as Sarah mentioned, having petitions bounced back and forth and having that included in every single condition, we’re looking at our own rules, and seeing if we can just amend the language there, uh, to state that the conditions added by this Board are understood to be refractory, and then also adding (?) of language about, what that actually means to give guidance to physicians in Iowa who are uh, who are prescribing.
Dr. Schreck: Um. You know, that was in fact the problem with the original pain diagnosis, that diagnosis was refractory pain, there was even a paragraph description of what refractory pain meant in the original marijuana legislation. And that caused problems because there’s excellent evidence in the medical literature. Prospective randomized controlled trials, done elsewhere, not in this country. Israel and Europe. And in publishing the (?) journals, that, um, medical cannabis is effective for refract, for chronic pain, not severe pain, the evidence for cancer pain is not good, but chronic pain, pain that goes on and on and on and won’t go away. And um, it was even a rationale for having that be the first treatment you try. For a number of reasons. You know, people are afraid of opioids, people have allergies to opioids, people can’t take uh, (?) because they’ve got blood conditions and stomach conditions and so forth. And so uh, you couldn’t try all all the standard techniques. Maybe the patient just comes in and says, none of those are for me, I wanna try cannabis, and there’s medical literature to support that. So that would not necessarily be a circumstance for this is the last ditch thing to do. And our efforts to persuade the Board of Medicine to uh, OK chronic pain, failed, uh, flat-footed, and we (?). That was a failure to communicate. We didn’t take the time and energy and to provide the resources to educate them, where we’ve been, where we’ve come from, and what the medical literature is saying. But we’re doing better now. We’re getting closer and closer. This would, anything that would bring us closer (?) would be great.
Joel: Certainly. And thank you Dr. Schreck, for coming to our Board meeting. We appreciate it. Absolutely. I certainly have been working with Owen, um, and (?) to work with on this. And hopefully our goal is to, to have this not bounce back and forth between boards, and we can just get these conditions – you can have more feedback from the Board, uh, prior to it reaching the Board, so (?).
Shelly: May I please ask a question. As the –
Sarah Reisetter: You know what, Shelly, this is not an opportunity for –
Shelly: But, when people are submitting these petitions do we have to have the word refractory?
Moderator: We can’t, we can’t do this.
Sarah: Um, ok. Board members –
Shelly: It’s about the 00
Sarah: — do you have any other questions for Joel? Ok. Is there –
Dr. Liesveld: I have one quick question?
Sarah: Yeah.
Dr. Liesveld: So just from a, legal definition, or whatever, what’s the difference between intractable, and refractory?
Joel: Well, refractory, I guess I can’t give you a great uh, answer to that. The refractory to acceptable standard treatment was the language that the Board discussed at the Board meeting, and we were gonna work on at our, at our future meetings proposing some um, rules, that would give a definition of that? So it wouldn’t just be that phrase. Um, so we are gonna work on trying to provide as much guidance to physicians. Because again, these are under the standards of practice for prescribing. So we definitely want to make sure that uh, and that was the Board’s chief concern, giving physicians enough uh, enough guidance on what needs to be (?). So.
Sarah: So, Joel I guess I would put out there that, you know, to the extent that the Board of Medicine would like to be involved, in the, you know, kind of getting the petitions when they’re filed, and providing some feedback to our board, as they consider that, I think that I would ask you in turn that our Board would have an opportunity also to have a look at this language that you’re considering, um, that your board is considering related to your conditions, so that they would also have an opportunity, you know, to provide input into what that looks like. Because, you know, I’m not sure what level of agreement necessarily that they might have on that particular topic at this partic, at this time. So, we would also want to have a meaningful opportunity to engage with your board.
Joel: Sure. Yeah. And I gave Owen a, a very preliminary draft, it hasn’t been looked at by the Board yet, some language I tossed around. Um, but certainly when we get some more language put together we can share that.
Dr. Schreck: There was a couple of introduced bills in the legislature, to get the Board of Medicine out of the line of fire completely. But even though they haven’t cooperated with us on everything, they’ve not seen the, they’ve not seen the proposals that we’ve rejected. They’ve only seen the proposals that we’ve approved and sent on to them.
Joel: Yeah.
Dr. Schreck: And uh, I would, as difficult as they’ve been to deal with – not really, haha – I would have personally and professionally proposed that idea. I think we need the Board of Medicine to, we need a widespread look at this. Because we see it from a little bit different angles. (?) in the line of fire is I think to the benefit of this program.
Joel: Um, thank you. Aha. And I think the Board agrees with you. If I’m not mistaken, they did declare against at least one of the bills that would take them out of the process. I think the Board considers their role to be serious and, you know, appreciates working with this Board, and wants to make sure (?) um, what’s best for Iowa Patients.
Dr. Schreck: A little bit of free nickle advice, or legal advice, excuse me. You’re legal, legal role in the Board of Medicine. Addressing Mr. Nelson’s concern about the CSA. Do you see a problem there? I mean, it’s an awfully off the cuff question –
Joel: It is. Hahaha. Uh, I mean, I am not at all an expert in the Controlled Substances Act. Um, clearly that’s a Schedule I drug. It makes it difficult to research and deal with marijuana large scale. Um, generally speaking, I should preface, this is not the Board of Medicine’s position you’re sort of asking – um, there hasn’t been a lot of enforcement, of even recreational use of marijuana that we’re seeing. So, whether they would target medical is unclear, but uh, that’s a question for someone with probably more expertise on (?).
Sarah: Well, you know, Joel, actually I can, I can answer that. So we’ve heard this concern (?) related to uh, allowing the physician to certify a patient for excess of four-and-a-half grams. Certainly I haven’t done a 50 state review of that, but our neighbors to the East, Illinois, their medical program has a provision in their statute that a patient can apply for a waiver where a physician provides a substantial medical basis, and a signed written statement, asserting that, based on the patient’s medical history, and the physician’s professional judgment, two-and-a-half ounces is an ineffic – is an insufficient adequate supply for a fourteen day period to properly alleviate the patient’s debilitating medical condition, or symptoms associated a debilitating medical condition, and then there’s administrative rules that, you know that implement that particular code section, that say the waiver shall include a statement by the physician (?) that would be an insufficient supply. Um, so, that is, you know, at least one other state has something in place that’s kind of similar to what your Board is recommending.
Dr. Schreck: Thank you. Very good.
Sarah: Ok, any other questions for Joel, before we let him out of the hot seat? Alright, ok. And so I think, I think the other thing that Rebecca mentioned during her public comment earlier was related to, you know, the chronic pain, the chronic pain order that you guys set up with the Board of Medicine as well as the PTSD order for them. I don’t think, we don’t have an order on our agenda today as an item for consideration. (2 hours 9 minute mark) Um, I think we’ll talk about chronic pain when we get to our conversation about legislation, what’s been proposed. But that would be something that the Board would consider putting on an agenda for an upcoming meeting. If you wanted to talk about resubmitting those conditions back to the Board of Medicine, understanding that there’s gonna be this kind of conversation about the refractory concerns that they have expressed. So, if you guys would like to have that discussion we can certainly go ahead and put that on the agenda.
Dr. Miller: I like that.
Sarah: OK.
Dr. Schreck: Are we, are we here with the (?) Have we discussed more of the autism issue (?)
Owen: It would just be at this point, my understanding is, someone would need to resubmit it. And that could be you, but my (?) it could be effectively denied, as it is. And the recommendation that, you know, you would have to resubmit a new petition, or somebody else would, or the Board of Medicine could decide first.
Sarah: Well, I think the other thing that we could do is, I think today, you could, because we have, we do have the autism issue on the agenda, so the other thing that you could do today is you could ask to resubmit that autism order that you sent down previously, um, with the understanding that they’re gonna have this, you know, continued conversation about their own rules. That may resolve the concern if um, you know, you guys would also agree to those concepts.
Dr. Schreck: You know, we ourselves, amended the petition.
Sarah: Right.
Dr. Schreck: We, we did what they say they can’t do.
Sarah: Well, that’s your authority to, if you don’t analyze it, they can make the recommendation, right.
Dr. Schreck: I think they did this for Dr. Miller. He uh, saved the day, because there’s no medical evidence of practicality in use of medical cannabis for autism. In fact there’s on the contrary lots of research done not to do it. Um, Lonnie, Dr. Miller, came up with a compromise, which is that phrase, you know, aggression and self-injury, which enabled us to what we considered to be compassionately approved that. We’ve already modified the petition, they want to modify it further. And um, Lonnie, it’s their idea. What do you think?
Dr. Miller: I think I would like to resubmit it with a modification of the title, so that we can be inclusive of those patients who are out of the pediatric age range.
Dr. Schreck: How about their further limitations, where they had the exact wording that they proposed? You may not have that in front of you.
Dr. Miller: I have that in front of me. I think that uh, at least we will from what I gathered from the last meeting, that some sort of modification, doesn’t have to be the exact words, would make it more palatable for the medicine.
Dr. Schreck: Sounds like a thing for the –
Dr. Miller: For instance, possible motion might be for severe autism with intractable irritability and aggression refractory to an acceptable standard of treatment might be a way to shorten it down to make it something that the Board of Medicine might reconsider.
Dr. Schreck: Uh, if that’s a motion, I’ll second it.
Dr. Miller: Uh, so moved.
Dr. Schreck: For discussion.
Moderator: Let’s make sure we have this.
Sarah: Yeah, we need to get the, we need to get that language right. We have, we’ll have it on the (?). But, Dr. Miller, will you repeat that one more time, please?
Dr. Miller: Yes. Severe autism, with retractable irritability and aggression, refractory to acceptable standard of treatments. I think the uh, Board of Medicine understands from other discussions that, uh, the devi, or, to apply behavioral analysis isn’t practical in a lot of the rural areas as a resource.
Sarah: Ok.
Moderator: So, motion the second, is there any further discussion?
Dr. Liesveld: I’m in agreement with that. I like the way it’s worded, adding the refractory and the, and the other word.
Moderator: Does it still give us some wiggle room to submit it to the Board of Medicine and see if they have any issues with the wording then, under the due process procedure?
Sarah: Well, what I think we would do, is, we will just, you know, update your prior order to name the condition, severe autism with intractable irritability and aggression, refractory to acceptable standard of treatments. To rename the condition in your prior order, update the date to um, you know, to reflect that you know you have had further discussion in this meeting and resubmit that petition to the Board of Medicine for their consideration.
Dr. Schreck: This has gone on for a long time in there, and there are people up there who benefit.
Moderator: Alright, is there any further discussion before we take a roll call vote? Dr. Liesveld? “Aye.” Dr. Miller? “Aye.” Dr. Stoken? “Aye.” Dr. Schreck? “Aye.” Myself, I, for affirmative.
Sarah: Ok, so we’ll do that, and then we’ll go ahead and add chronic pain and PTSD to your agenda, in May, and then we can have this similar conversation in terms of how we might address the language. By then we’ll probably have some information from the Board of Medicine to about, kind of what they’re proposing is, the overarching concept.
Moderator: Considering the rules —
Shelly: Then we have to wait for May. Bullshit! You’ll do it for kids, but not for veterans. **Walks out dramatically**
Moderator: considering the rule for the timeline of review for repeat petitions (?) for a rule for review of petitions.
Sarah: Sure. So, um, and I’ll probably also, um, I’ll offer this a little bit. I think some other states have limitations on, considering petitions for conditions that have been previously addressed by their decision maker, whether it’s, you know, the commissioner, the department of public health, or a board, or whatever, the responsible party is for making the decision to add additional conditions. I think, in some of those cases, um, it might be, you know, a petition with the same condition cannot be considered for a year for a certain period of time, unless there was additional new research that’s emerged since the last time that petition was considered. So, Owen, do you have anything else that you want to add to that?
Owen: Um, not necessarily. It was something that the Board actually brought up previously. Um, I believe at the August meeting. And so it was just something there had been (?) as it is, again, not defer this to patchwork framework, as far as a six month to one year timeline, he wanted to, (?).
Dr. Schreck: I think that we were copying Minnesota in that regard as well. Because they do have a limitation on resubmitting. But I think our discussion did include at the time, if there’s new evidence, if there’s new medical evidence, (?) that we could certainly be able to (?).
Sarah: So, I think if that’s something the Board is in favor of, you know, the Department of Public Health would be the entity responsible for adopting those rules to our State Board of Health, and so we have a couple of other things I think that we need to do, but what we would propose is that we would draft up some language related to this petition, um, submission issue, and we’d send that to you just for, you know, to provide individual feedback to see if you think that that’s, you know, meeting the mark. I think certainly we want to make sure that petitions can be submitted, that they’re evaluated, you know, in a timely way, but they do take time enough for the sorts of review that you guys are doing. So we would certainly roll in this concept of, again, this new informational research that is available since the last time the Board had considered it, but that timeline would not necessarily apply. Does that sound ok with you guys? Ok.
Moderator: Item 11. Review and discussion of pending legislation. Sarah again, would you like to lead this discussion about –
Dr. Schreck: That might take awhile. Can we take a break?
Sarah: Yeah, that’s, that’s, yeah take a break.
Moderator: Ten minutes?
Sarah: Ok. Back at 12:30?
Moderator: Yep. Ten minute recess, everyone.
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