Transcript from Medical Cannabidiol Advisory Board Hearing August 3rd 2018 Ankeny Iowa [TRANSCRIPT]

This is an unofficial transcript, first draft.

Medical Cannabidiol Advisory Board Hearing

Medical Cannabidiol Advisory Board Hearing August 3rd 2018 Part 1 etc
August 3rd, 2018

Ankeny Iowa

Part 1

https://www.iowamedicalmarijuana.org/Iowa/MCAB_2018_08_03_1.

Moderator: Here’s when I think we’ll go ahead and get started. I officially call to order the August 3rd 2018 Iowa Medical Cannabidiol Advisory Board meeting at 10:02 am. Next item here, we’ll take role call. Dr. Cheney?

Dr. Cheney: Here

Mod: Dr. Liesveld?

Dr. Liesveld: Here

Mod: Dr. Richards? Absent. Dr. Schreck? Dr. Schreck, are you on the phone?

Unknown: Alright. Or are you on mute? No, that’s the end mute.

Mod: We may have Dr. Schreck joining us later. Right now absent. Dr. Stoken?

Dr. Stoken: Here.
Mod: Dr. Zadeh?

Dr. Zadeh: Here

Mod: Next item is uh, approval of minutes. Now time to approve the minutes from the May 4th, 2014 Iowa Medical Cannabidiol Advisory Board meeting. Has everyone had a chance to review the minutes? Are there any questions or amendments to the minutes? Alright. I’d like to entertain a motion to approve the minutes. Um, someone want to make the motion. Ok. Is there a second?

Unknown: Second.

Mod: Ok. Any further discussion? Hearing none, all those in favor to approve say “Aye.”

“Aye.”

Mod: Any opposed say “nay?” Ok. Motion carries. Item 4 on the agenda, with the MCB legality and liability for positions. Heather Adams, Assistant Attorney General and legal counsel for the Board, will share with us a presentation on medical cannabidiol legality and liability for positions. Heather, thank you.

Heather Adams: Alright I’ve got just one hand out. I’ll pass that around. And it’s just a copy of the statute, which you all have gotten in orientation but just in case you don’t clear that (unintelligible) like we do. Um, so just a couple of caveats at the beginning. Um, you know my role here is to advise you, and to advise the Department regarding implementation of the statute, not to provide legal advice to individual positions. And your (legal?) is similar, so you’re here to implement the statute, you’re not here to provide legal advice, or any other advice, to individual positions. But I think having said that, you know there’s certainly some clear areas of the law that have prospective physician liability that we can review and perhaps provide some guidance and comfort to physicians that are involved or want to be involved with this program. So, that’s what I would like to do this morning.

I thought it would be helpful to just start out with a little refresher about what the physician’s duties are under the statute, and so if you will turn with me to page two of the act. Actually, the very first substantive section in this act talks about what are the duties of the physician relative to the patient. And so, it’s that middle section, S 124.123. And really there’s three duties that you’ll see outlined here, and the first is making the determination, about whether the person has the medical condition. The second is if so, providing the written certification. And the third is providing that information from the Department about the risks and benefits associated with providing the medical marijuana, the CBD in our case. You know, again, I think it’s important to point out, it’s not a prescription that the physician is making or handing to the patient, it’s a certification. And so that’s an important distinction when we think about some of the liability issues. And I think, you know, to unpack the statute a little bit is also helpful, in looking at what the physician does and doesn’t do under our statute. So, in making the determination, the Legislature has said, first of all, you rely on your medical judgment, um, and you have to examine and treat the patient to determine they have that debilitating medical condition. So, that’s an important piece that’s built in is that there is that responsibility for the physician to examine and treat and determine that that patient suffers from the condition and qualifies for use of medical cannabidiol. And then they can go get a written certification, and we’ve talked about that, and that’s done under the Department’s forms. And then providing the information about risk benefits and side effects of the proposed treatment, and the Department has on it’s web site, and I have here are some copies if you’re interested. I know that you’ve reviewed the substance of what that looks like but really just telling the patient, here’s how it works, how we go about it, what the benefits are, um, how it’s used, and what the principal side effects might be. So, um, that’s just a quick refresher, but I think those things are important when we look at liability issues. Just understanding the limited scope of the physicians involvement that we have here in our city.

Questioner: If it’s ok to interrupt you. So my question is, is this risks, benefits and side effects, I think it’s kind of a big umbrella, is it possible to take that, away? So the patient can just be told they can look at that themselves? Simply because we’re not dealing with a studied treatment, where there would be clear risks, benefits, side effects. You know what I’m thinking?
Heather Adams: Right. And I mean, what we have here, is we have implement what the Legislature has given us. And this is the language that we have in the act. So, I think that if physicians are going to participate, they need to follow the section and provide that information. I mean I, we’ve talked about, you know, are there better ways to do this, would it be better not to have a physician involved at all and just have someone pull that code from the medical records, and I think all those things are ideas, but, what I’m really trying to do is look at, what’s the guidance that they’ve given, and how do we make sure that physicians are following that guidance.

Questioner: Right. And I’m just parenthetically saying, that I don’t find that (unintelligible). You know. That’s all that I’m saying.
Heather Adams: Yeah. And I think the piece about, that I see is limited, is the Legislature saying, you give them information that the Department of Public Health has provided. So, we’re not saying to physicians, you’ve gotta go out there and scour the literature and come up with some guidance. What the Legislature is saying is, we’re going to have the Department of Public Health put that together, and then that’s what you give your patients. So, that’s my sort of limited role that I see for the permission there, is they’re not responsible for putting that document or uh, that that special together.
Questioner: Does anyone have some other important questions on that? Does it bother anybody?
Questioner 2: So, from my standpoint, I’m ok with the wording that you’re just handing me information that the Department has provided. I don’t think that we necessarily need to do all of the, you know, the leg work and the side effects and benefits. I mean that’s just the way it’s worded. And that’s the role that they’ve captured for the physicians that’s involved. So, will that be easily available to the physicians on the website?
Heather Adams: Yeah, see, it’s prominent on the website right now, where I know that the Department is doing some education too with the physicians too to help them have access to that document.

(Note: Document available as of 11-18-2018 at this link: https://idph.iowa.gov/cbd/For-Physicians )

The Following document is an information sheet that physicians are required to discuss with patients. It provides explanatory information about the possible risks, benefits and side effects of medical cannabidiol.
• Patient Information Sheet
Heather Adams: But it took me I think three clicks to get to it this morning when I went and pulled up copies. So, it’s, so far —

Unknown: Because I’d like to put that in the newsletter, with, for the estopathic (sp?) position, so that they know where to go to find it.

Unknown: And I believe also, in the written application that somebody provided to you, there is the link, the URL .

Heather Adams: Certainly we’re trying to be sensible.

Lucas Nelson(?): Certainly we’re trying to work to improve as well. Something we’re building in the background all the time.
8’ mark

Unknown: Does the patient sign off? Do they understand where to sign all of this?

Heather Adams: There’s not a requirement for the patient to sign off. You know I think that it is good medical practice that you document that you’ve given them that information. That’s, you know, again just showing that you complied with the statutes, that you’ve examined them, that you’ve made the determination, you’ve given them this handout. Those are things that can be documented in the record.
Unknown: So when patients read under the risk and benefits, will it say, this may interact with your other meds and cause toxicity with it, for example.
Heather Adams: There is a statement about both potential side effects with other medications and then contraindications for use. Um, and you know, again, I think we’ve talked about, we’re always open, at the Department, to your guys (unintelligible) on this document. Because that’s, it’s helpful for us to make sure that this is as beneficial for patients in understanding what is out there.

Unknown: Absolutely. We’re happy to field that information from you. But it’s ultimately we are (unintelligible) we want to give you the information that will help you do the best job.

Heather Adams: So maybe we could have that printed out and then be invited for feedback on that, formally?

Unknown MedPharm: Yeah.
Heather Adams: So what I hear, primarily, from um, this Board, and then from staff and professions that I am getting really relate to three questions about physician liability. And the first is, uh, from physicians, if I participate in the program, am I in danger of criminal prosecution? Or are, am I putting my staff in danger if they are participating in this project? So if I’ve got a patient that gets picked up, they’ve got the product, it’s traced back to me somehow, am I at risk criminally for being prosecuted? And so I wanna talk through what the statute provides about that, question, and I think the answer is clearly under the statute, no, we are not at risk of criminal prosecution. The affirmative defenses are contained towards the end of the bill, on page 9, and then on Section 124E.12. And the very first section in that paragraph deals with this issue of criminal prosecution and provides that healthcare providers, including your agents and employees, are not subject to prosecution for any acts involving certification, possession, administration of marijuana under the laws of the state. Any activities that arise out of or are related to your certification for the patient’s use in treatment of a medical condition as authorized in the chapter. So that’s uh, I think some assurances to physicians in terms of that criminal element there’s not a risk of criminal prosecution provided, again, that you follow the statute that we just reviewed regarding that certification.
The second question that we’ve reviewed is, if I participate, by providing the certification, am I putting my medical license, or my DEA registration in jeopardy? So, we’ve had that question come up.

And again, I think that the Legislature’s anticipated that and answered no. Your license is not at risk for participation. That particular provision is in subsection 6 of this same statute on page 9 and provides that healthcare practitioners are not subject to civil or disciplinary penalties by the Board of Medicine, or by any business, occupational, professional or licensing board or entity again for providing that certification in related to the patients possession of medical cannabidiol under the chapter. So that’s a statement regarding um, the license, and I think the Legislature, speaking clearly to whether the Board can take action, and removing that possibility provided that we have that participation. With respect to the DEA registration, there has been some case law about that issue from the 8th circuit. So we have some good guidance that physicians cannot, are going to be, subject to DEA sanction for providing that information, or providing information to their patients about the use of marijuana. And I have that case with me if any of you are more interested specifically in having a copy of that, I did bring copies.

And then the final, the third question that I think we’ve talked about here and I’ve received too is if I’ve participated am I going to be sued for malpractice? Or are my patients going to be able to have a malpractice action against me?

And I think what we can say definitively there is what’s happened across the country. And so, we’ve done pretty thorough reviews from West Law, from Med Scape, I’ve looked at the American Bar Association and Health Lawyer. There are not any reported cases across the country in those many many states where programs are being implemented. We have not seen a single malpractice case regarding a physician’s involvement in the program. So, again, I’m not saying that it can happen, I’m saying that it hasn’t yet happened, and I think that that’s important when we look at how far ahead some other states are in terms of implementing their programs and what they’ve seen regarding physicians. There’s a little bit of guidance out there from some attorneys in this area. And what I’ve seen cited are legal experts saying they think the legal risk is minimal. Again, it’s not non-existent, but that’s the phrase that I see, is minimal. And part of that relates to the fact again that you’re not prescribing, your certifying, so your role there is limited, that you’re providing information some other source has given you, you’re not providing that type of information. So, I think there’s some, again those things in the statute. And the cases I’ve seen, all that I’ve seen reported of doctors either being sanctioned by the Board or having some kind of action, are really those cases where physicians have taken actions that I think all of us would say were outside the pale, or really were clearly inappropriate actions. I saw actions in three states, one from Colorado, where a physician was disciplined for setting up toddlers in hotels to see patients who were seeking recommendations for marijuana, and they weren’t actually his patients, so he just kind of funneled the paperwork through these different venues. There was an Arizona physician who issued 483 certifications without ever actually seeing the patients that he was involved with there. And then a Maine gynecologist who lost his license for writing medical marijuana certificates for men who were not his patients at all. So, really, those are the only three actions that I can find referenced, and I think that, again, they’re actions where physicians were acting very clearly outside the parameters that were set up in the statute. So, the last couple things I’d say with respect to liability, I mean we talk about providing a standard of care for the physicians. And here, what that means I think is you comply with the statute to those things that we’ve already talked about. And then, the Board of Medicine has also adopted some administrative rules to provide for the standard of care for physicians. And those are in their sectional rules where they lay out standard of care for a lot of different kinds of practice. So, there’s standards for pain management, they have standards for tick borne diseases, standards in several different areas. And basically what they’ve done there is to say, you need to follow the statutory provisions. And then there’s one additional requirement that they’ve outlined, which is not to have an office that’s located with a dispensary or manufacturer. So, just looking at that financial relationship I think there. Um, so they’re just saying, make sure you have an established relationship, do the certification, and provide the information in terms of what that standard of care would look like. That’s truly what we have in terms of what that standard looks like for our state. So, again those are kind of the three areas of physician liability that we’ve um, fielded up, at the Department, there’s some things obviously that we don’t know because these programs are new, but in terms of what we do know, I think we can pretty clearly say that criminal prosecution is not a problem. Board licensure is not an issue provided the statutes followed, and then, you know, we’re just watching what’s happening around the country regarding with respect to malpractice but at this point, not seeing any reported cases regarding physicians actions in those areas.

Unknown: So do you perceive any problem if an individual institution wanted to have their own form, where they had the patient, in order to be part of the program, sign that they accept potential risks and benefits?

Heather Adams: Yeah, and you know, I think that some of those questions that I’ve gotten, I don’t see our Board or the Department’s role to give that advice. Those people are going to be saying to their attorneys, for their clinics or their hospitals. And they also need to be talking to their malpractice carriers I think about this issue. And talking about, you know, that very issue, mal, what they think is appropriate. I don’t think we are going to be, and I don’t think we have the authority to be, sort of drilling that sort of advice to providers.
Unknown: I guess why I’m asking you, is there anything in the paperwork that would preclude an individual institution adding their own, um, charted information that a patient signs?
Heather Adams: That’s not precluded by the Act.
Unknown man: There’s somewhere in there that talks about, I think you used a different term, but I think like “ongoing relationship” or something like that like “established patient,” you know what I?
Heather Adams: Right.

Unknown man: So, if somebody came in to see me, and I certified that they had a condition, and they just came back, when I had to recertify them, is that an established relationship, or how do you interpret that?
Heather Adams: No, it’s not, I don’t think that’s the term – the statute uses the term “primary care provider,” and then you in the rules of the Department, we define that as a healthcare practitioner involved in the diagnosis and treatment of the patient’s debilitating medical condition. So, as long as you’re involved in that process, then you’re complying with the statute in that respect.
Unknown man: So how about if like, if somebody had Ulcerative Colitis and used a gastroneurologist but they only see them infrequently and I’m their primary care provider and I had a certification from them that they have ulcerative colitis. Does that mean I have an ongoing relationship with that patient but I can’t certify them even though I’m not treating that condition?

Heather Adams: I think that would go, you know, are you involved with that diagnosis and treatment of that medical condition in any way? And so there are patients obviously that have that primary care provider, and then they also have a neurologist who may see them specifically for Parkinson’s or another condition, and those physicians could be involved.
Mod: Are there any other questions for Heather? Ok. You’ll find item 5. Reference: Medical cannabidiol and practice. Iowa physicians perspective. Dr. Jones Smith. Dr. (unintelligible) here? We’ll take a minute. While we’re doing that, Dr. Schreck, Dr. Richards, have you joined in on the phone yet? Apparently not. Ok. Dr. Schreck we’re testing the volume can you speak again please?

Dr. Schreck: Yes, I can count one, two three.

Mod: Alright that’s better we can hear you now. So we’re just getting the next speaker set up it will be a couple minutes sir.
Dr. Smith:

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Dr. Smith: Maybe I’ll stand back here. Does anybody care where I stand? (29:35) So, my name’s Dr. Jolene Smith. Thank you for allowing me to present today. A little background on myself. I am, my medical school training was at Des Moines University here in Des Moines. I did my anesthesiology residency at Mayo Clinic in Rochester. That was followed by my fellowship at Pain Medicine again in Rochester. I’ve been in private practice here at Medical Center Anesthesiologist Pain Specialists of Iowa for the past three years. Although I do hold dual board certifications in both anesthesiology and in pain management, my practice is 100% pain. Which means five days a week this is all I do.

I started to become interested in medical cannabis as I was in Minnesota. During my fellowship training, the program was developing and then after I left the program had launched. So they’ve now had over three years of survey data that they’ve collected and I’ve maintained an interest. And so now that Iowa has a medical cannabidiol law, I felt it was important to present from the medical perspective what we see in pain practice to you guys.

So I am a consultant for Boston Scientifics it should have nothing to do with what we are discussing today.

Just, my disclaimers here. These are my opinions based on the information I have gathered the research that I’ve done. This does not represent what Pain Specialists of Iowa, Medical Center Anesthesiologists or Mercy Medical Center which we’re also affiliated with, this is not their opinion. I’ve done my best to present real information that’s out there. Excuse me. And, again, use medical judgment when basing medical decisions on this information. The other is I apologize if I seem short of breath during times. I am carrying a 7 month old inside and she’s taking my breath away, so. (Laughter) So I’m putting that out there now because I may not look it but I am.

So this is what we’re going to go through as we proceed through this lecture. We’ll first briefly introduce cannabis. We will then go into the cannabinoids, specifically, the receptor types in the body that the cannabinoids work on. We’ll go into the CBD, Delta-9 and THC. We’ll focus mostly on those two compounds. And then other cannabinoids we’ll briefly discuss. We’ll then introduce the pharmaceuticals. A lot of the information that I’ve got are from the pharmaceuticals because research has been done. Ok so that’s what we know. We’ll then go through the pharmacology, specifically routes of administration, dosing, some expert opinions will be represented in the dosing based on communications. But again pharmaceuticals are where we’re going to get most of the dosing information that we know. I’ll then present research on safety, followed by benefits on pain. I may not be able to answer or address questions related to other certifiable conditions as my expertise is in pain, so I apologize if I can’t give somebody an answer if they have a question but I’ll present data that’s out there in regards to pain. Then we’ll talk about the opioids and how cannabis, cannabidiol, can be utilized together. We’ll talk whether it’s an either or an or, or what studies show the use of both of these synergistically. And then at the end we’re going to talk about the Iowa law, and some suggestions I have for the medical board and follow that by our concluding statements.

So, marijuana, one of the oldest cultivated plants, thousands of years ago there’s evidence of people using this for medicinal purposes. It started it’s regulation here in the United States in 1937. That was with the passage of the Marihuana Tax Act. This was a first step in regulation. And then in 1970 it was classified as a Schedule One drug under the Controlled Substances Act. Interestingly we’re gonna see in the next 60 days, so in September the DEA is going to have to reschedule Epidiolex, as CBD is a component of marijuana, and currently CBD would then fall under Class 1. So Epidiolex, and we’ll go into that in more detail is recently passed through Phase 2 trials, it’s ready for market in the United States. Again it can’t go to marketing until there’s some rescheduling, because again it’s illegal for any practitioner to prescribe a Schedule One drug.

So let’s talk cannabinoids. So, cannabinoids, essentially, are a multitude of chemicals that interact with a cannabinoid receptor. So a cannabinoid, cannabinoid receptor. Endocannabinoids, endogenous, which means, within our body. There are two that have been identified. Anandamide was the first one in the 90’s. Essentially what that means is we produce chemicals internally that also bind to the same receptors that external inhaled forms typically but other ingestible forms of marijuana also bind.

Phytocannabinoids. Plant derived. Ok. These include Delta-9 THC, CBD, and others in the cannabis plant.

Synthetic cannabinoids. Made in a laboratory. Ok, the one that we’re going to parallel and discuss today is Marinol. That is identical to THC although it’s synthesized in a laboratory. The other times that you may hear synthetic is when people are talking about Spice or K2. Again these are chemical compounds synthesized in the laboratory that work similar to THC but bind differently. These synthetic compounds are meant to bind significantly more strongly to the cannabinoid receptors, ultimately leading to a lot of the adverse effects that we’re seeing. When we say synthetic THC all we’re saying is it’s manufactured in a laboratory. It’s going to be important to know are we talking Marinol, are we talking the things off the street?
This is what the typical cannabinoid receptor looks like. It’s a transmembrane G protein. CB1 is one aspect of or is one category of this receptor, typically found in the Central Nervous System. Lesser degree is it found peripherally.
CBD2 is the opposite mostly found peripherally especially in the immune system. A small proportion of this is in the Central Nervous System.
This is a pictorial representation of the sort of the vast majority of compounds found within the plant itself. The cannabinoids include things like THC and CBD. That’s important for us here in Iowa. There are other cannabinoids: CBG, CBV’s, CBC’s, and then there are non-cannabinoids such as the flavonoids, the ligands and the terpenes. Over 500 compounds. So research is currently being done not only on the other cannabinoids but also on the non-cannabinoids to determine medical efficacy. There’s not much out there yet but with over 500 compounds there’s a lot of potential within marijuana, but for the purposes of today, we will focus on the top two, which is THC and CBD.
So here is a chemical structure of THC. Ok, so THC comes in three stereo isomers. This is directly from the plant. In the plant form it is an acid. It is converted to an activated form by either CO2 or heat. This binds both to CB1 and CB2 receptors. This is the psychoactive component of the marijuana plant, because of the binding to CB1 receptors which as I mentioned earlier, mostly Central Nervous System. Again this is under Schedule One for the DEA because it is part of the marijuana plant.

Dronabinol or Marinol we’ll talk about next. The reason is Dronabinol is the synthetic THC. This is identical in chemical structure to CBD – ah, to ah, plant based THC. As you can see all, if you look at the chemical structure on the right here and if we flip back it’s identical. Ok?

Marinol or Dronabinol basically comes in two forms. One is Marinol, which is the capsules in Syndros’s liquid. The FDA has this approved currently for anorexia and patients with AID’s. And then nausea and vomiting with patients undergoing chemotherapy.
Sesamet is another, so this is a synthetic similar to THC, but as you can see the chemical structure is not identical, I will mention it because it’s a pharmaceutical is available, but we won’t focus on it when we talk about research as it is chemically different than the actual THC which we will be providing to patients here in Iowa. Capsules, this is an oral prescription. FDA has this approved for chemotherapy, nausea, vomiting, for patients undergoing chemotherapy who have not responded to, you know, other medical, conventional treatments.
Cannabidiol or CBD. Ok. So here’s the chemical structure of that. Again. Plant derived, precursor in the plant, needs to be converted to the activated form typically by CO2 or heat. This binds to CB1 but only weakly. This is mostly binding to the CB2 receptors. Because of that it’s not psychoactive. There is no evidence that I could find, and by talking with expert opinions I have no evidence to say that there is any psychoactive component of the CBD on it’s own. Because this is part marijuana it falls under the Schedule One category. And, there is strong evidence for efficacy in treating seizure disorders. Ok? This is the CBD alone. Epidiolex is the exact same. It’s basically, I mean, CBD. It’s the exact same compound as plant-derived CBD. Oral solution. The FDA approved it in June of this year for seizures associated with minosygost (spelling) syndrome and Dravet syndrome. So sort of rare seizure disorders, but again, before it’s put to market there needs to be a reclassification on the uh, scheduling of it.

Now Marinol is currently listed as a Schedule III by name. So they did not have to reschedule marijuana in order to replace Marinol into Schedule III. So I doubt anything is going to happen with marijuana still being a Schedule I. Most likely, the DEA will name Epidiolex independently either as a lower scheduled drug or a non-scheduled drug depending on the risk of abuse and of overall efficacy.

Sativex. Um, Sativex is essentially a 1:1 ratio of CBD to THC. Again this is important for us in Iowa as this ratio will be available to our patients that we certify. There are some other minor cannabinoids you know within that product but what we are going to focus on is THC and CBD. This is plant derived, this is not synthetic this is plant derived. It’s, the formulation is a mucosal spray. 21 countries have this approved, it is not yet approved here in the United States for the treatment of multiple sclerosis. It is in Phase 3 trials however. Again, chemical structure is listed, just showing it is an equal proportion of THC and CBD, with some other minor cannabinoids as part of the compound as well.
So that’s an introduction to the pharmaceuticals that are out there, an introduction to how these compounds that work in our body. Let’s now talk about some pharmacology. Different routes of administration. Inhalation after combustion yields high bioavailability of both THC and CBD compared to oral. Makes sense. You don’t have to pass through the liver to become activated. You have a direct source to the brain. Around 30% on average of THC and CBD are available immediately after smoking or inhaling, and then 6% typically after oral ingestion. This is going to be important when we start looking at studies. You know, most of the studies that are out there were before oral based preparations were available. So most of the studies we’ll talk about inhalation, inhalational forms being researched. But again if we’re talking about milligrams of THC per study, or CBD, recognize that it might be much different between studies depending on the route of administration.
Pharmakinetics specifically of Delta-9 THC. Peak plasma levels occur between three and ten minutes, and then the typical “high” that the patient will experience or the person will experience, typically within twenty to thirty minutes after smoking. So fast onset of action. Oral, much more variable. Between sixty and one hundred and twenty minutes is when you get your peak plasma levels. And it can be delayed upwards of four to six hours. It can be effected by food within the stomach, overall metabolism, other medications somebody might be on. But again 6% is bioavailable, typically after oral ingestion, plasma levels will fall sooner than brain levels just because of lipid salability.

Unknown man: “Can I ask you a question?”

Dr. Smith: Yeah?

Unknown man: “Is there a difference between oral and sublingual? So when you see, is there trying to get it to be absorbed or something or…
Dr. Smith: Yeah. Great question. So typically sublingual is going to be absorbed moreso into the blood stream. And have a direct effect and bypass first pass. Now is that 100%? Probably not. Some of that’s going to be passed through first pass but with any other sublingual medication positive action tends to be closer to ID formulations, or, formulations that bypass first pass. Again whether it’s 100%, you know bioavailable based on similar to IV I don’t know to say exactly, but it should be and is most likely more bioavailable than swallowing.

Unknown man: “Thank you.”

Dr. Smith: And then the pharmacokinetics of CBD are similar to THC. So faster onset for inhalation, slower onset for ingestion. This is more, fyi. So as physicians we understand that there are a lot of interactions in anything that undergoes metabolism through the cytochrome P450 system within the liver. THC is predominantly metabolized by this cytochrome system. What this means is there can be a difference in how it’s metabolized, whether it’s prolonged, whether it’s slower metabolized or whether it’s prolonged in the body or whether it’s rapidly metabolized and is eliminated quicker. Also it’s highly protein balanced. So high protein drugs can essentially displace this from proteins making it more activated. So this is more of an fyi slide, so that when we have patients on medications that can either induce or inhibit the cytochrome system, look at whether they’re using medical cannabis products because it could change their side effect profile or how it’s working. CBD is also metabolized apatically, so similar, so whether it’s THC alone or CBD alone or a combination of the two, it’s important to always understand drug-drug interactions can occur.
So dosing. Ok. Like I mentioned earlier, many trials for cannabinoids for pain, specifically for pain which is what I have focused on, use the inhaled form of cannabis or vaporized cannabis. OK? And, understanding the bioavailability differences is important when understanding how these studies are done. Currently no inhalation forms are approved in Iowa. So what we’re going to focus on for dosing are what we know, which are the pharmaceuticals, that are THC, CBD, or the combination of the three which I introduced earlier. According to experts, so speaking to and directly through Dr. Ware and Dr. Wallace, um, Dr. Ware is from Canada, a very large advocate for the Canadian Pain Society, has a lot of patients within these programs. These programs within Canada have been available and open for years. And then Dr. Wallace from UCSD who is in a state where this has been available was also contacted. So basically they’ve come to the same conclusion. There’s really no safety concerns with CBD. Ok? Dr. Ware believes 2.5 mg of THC two to three times per day is a conservative starting point. OK? And it’s in line with the dosing of Sativex or with the pharmaceutical THC. Typically you can use higher CBD ratios in the daytime as they do not cause as much somnolence as we will find later when we talk about side effects as THC, but often times for patients who have a difficult time asleep with their pain, increasing their THC proportion can be beneficial. So essentially the experts in the field from the front lines say really no concerns with CBD, starting slow or starting low and increasing low is the best approach.

So let’s look at how Marinol is dosed. Again, identical to THC. Ok? Currently for this is the FDA indication, chemotherapy associated nausea. The recommended starting dose equates to a daily dose of 15 to 20 milligrams of THC per day, ok, in divided doses. Titrate slowly, they don’t want to define what that means, but as healthcare practitioners typically titrating slowly means allowing enough days to pass to determine efficacy and side effects before making a dose adjustment. Typically in the order of 3 to 7 days. Their maximum dose equates to a total daily dose of 135 to 180 milligrams of THC per day.
Dosing of Epidiolex. So CBD. This is again for those two seizure disorders listed. Starting dose is based per kilogram. So 2.5 milligrams per kilogram twice per day, they recommend if you increase to wait for a week. And then the maximum recommended dosing is 10 milligrams per kilogram twice per day. So if a 70 kilogram adult, the maximum dose is 1,400 milligrams per day. So obviously much higher allowable doses with Epidiolex compared with Marinol. And again this is most likely due to safety profile and potential for side effects.
Sativex combines the two. So again, not available here in the United States, but we can look at dosing information as 1:1 ratios of THC and CBD will be available to our patients here in Iowa. These are based on sprays, so per day, 5 milligrams of each, so two sprays per day. Titration is recommended. And it’s some of this uh, some of the trials that were performed, some of the patients were allowed up to 48 sprays per day, so that equates to about 120 milligrams THC and CBD allowed per day. This is what, after speaking with some of the experts, this is a lot of what they’re using for their titration schedule, is they’re following the Sativex dosing, so again, inhalational forms are not available here in Iowa but this just shows you that typically starting low and going slow is going to be the best way to maximize efficacy so finding the lowest effective dose while reducing the risk of adverse side effects.
So safety. Safety’s always a big concern. As a physician we wanna know why, you know what’s the safety of something that we are recommending or prescribing and what is the overall benefits. So we’ll first focus on safety.
Cannabis adverse effects. Ok. So the risks, so this comes from a paper, 2011, looking at the DSM-4 criteria, but cannabis lifetime risk of, based on this study, of dependence was 9%. Uh, 67% for nicotine, 22% for alcohol and 20% for cocaine. So much less risk of dependence and withdrawal symptoms if taken away and compared to these other three compounds. These are not looking at medical cannabis users. These are looking at recreational cannabis users. We’ve heard of cannabinoid hyperemesis syndrome. Not common. This is in long term heavy recreational users. We’re talking years of use. Often times present to the emergency department with dehydration related to uncontrollable vomiting. Support of care is the treatment, give them IV treatment and have them stop using. Symptoms will improve.

THC specifically or cannabis overdose. Overdose severe enough to cause depression of consciousness should be treated with the normal precautions for dealing with an unconscious patient, right? Supportive care. Um, sometimes with a, with a high level of ingestion, immediate responses can be psycho, you know psychological. They can become paranoid. They can have hallucinations. So typical treatment is you can put them in a quiet room, shut the lights off, and wait hours. Typically the symptoms resolve within hours. Sometimes benzodiazepines can be utilized for that anxiety effect, but really it’s time, take your time, take them away from, you know, stressful or something that’s going to perpetuate their reaction. In the emergency department they typically put them in a quiet room, symptoms will improve.
So these are the short term effects. What are the long term effects of THC? How can we make decisions, how can we educate patients. It can transiently cause tachycardia. This is important when we are certifying. Does someone have an uncontrolled heart condition? Do they have an arythmia? Are they prone to tachycardias? This is not going to be a good thing for them to have. Higher doses, which as we mentioned can cause anxiety, panic, confusion or disorientation. It can prevent transient psychosis like states at higher doses. This is especially problematic in people with known psychotic disorders. Schizophrenia, bipolar with psychosis, or even first degree relatives. The experts in the field say they are very cautious in recommending this if that history is present. It can impair attention and short term memory. Cognitive psychomotor and perceptual alterations typically lasting three to eight hours. And then it has been proven to cause driving impairment in both on road and simulator tests. This is dose dependent. This is both occasional and in heavy users of cannabis. Again none of this is known as far as medical users. These are typically observed in recreational users.

So typical side effects observed in clinical trials. So this summary of randomized controlled trials was looking at studies through April of 2015. The studies represented in this conclusion were of all sorts. THC only, CBD only, and combinations. They were associated with the increased risk of short term adverse effects, and the withdrawal of treatment due to these adverse effects. Most common however were dizziness, dry mouth and drowsiness. So really what we would expect. No significant or life threatening adverse effects. Mostly these three, we’ll see as we move forward, that’s typical of all of these studies.
So what Minnesota has done with their definition under intractable pain is they send out survey data. And they’ve been able to collect a lot of survey data from utilizers of the cannabis plant plus the certifiers. So Minnesota, we know that there is varying ratios of THC and CBD available. And under the qualifying, intractable pain definition, they reported these side effects, so, dry mouth, drowsiness, fatigue, mental crowding. So similar to the randomized controlled clinical trials that I just reviewed.
So adverse events most commonly reported, dizziness, dry mouth, drowsiness, nausea, vomiting. Ok? There is a three year trial, this is a prolonged study looking at Marinol in patients with multiple sclerosis. And basically what they found is nothing new compared to what was previously recorded. So no new safety concerns outside of the safety or the side effects noted in the other studies. This compass trial is looking at THC, a lot of these were previous THC users who were habituated so the milligrams were much higher, so again there was no increased risk for non-serious adverse effects.
And they did note that there was a reduction in pain. And any study that I’m referencing here, which I’m not going into details because we’re going into a lot, is referenced at the end of the lecture. So if you would like to look at any of these studies in more detail please refer to the references as they are available.
And again, contraindications for THC, poorly controlled heart conditions, history of certain psychiatric problems, substance abuse in pregnancy or breastfeeding. And again these studies show that there is a low risk of dependence. And in support of THC overdose.
So now let’s look at drug labeling. Ok. So we’re gonna look at these pharmaceuticals to find out what they have in their packages, as far as their package inserts. So under Marinol, neuropsychiatric adverse effects, we’ve talked about that, they recommend not operating motor vehicles until the patient knows how it effects them. Chemodynamic stability, again, uncontrolled heart beat, be cautious when prescribing Marinol. Seizures and seizure-like activity. Ok. So, there can be seizure activity, especially with discontinuation abruptly from Marinol, so there is thought that it can lower the seizure threshold, so again, somebody has a history of seizure activity, know that up front and be cautious when doing those titrations. And then of course multiple substance abuse. Anyone with a history of substance abuse you should be cautious with when treating with Marinol. And then paradoxical vomiting or abdominal pain.
As far as Epidiolex, from the safety label, generally well tolerated with good safety. To date there’s no evidence of recreational use of CBD or any public related problems with just pure CBD. No abuse liability identified. Most of the adverse effects are listed there, some are very similar to THC. Warnings, this is, and this can cause hepatocellular injury, this is obviously for patients with seizure disorders who are most likely on alternative or additional antiepileptics which can create transaminus elevation, so following liver function is going to be important. And then again, don’t operate motor vehicles until you know how it effects you. There has been, or at least on the labelling, there has been concern about suicidal ideation. And then of course if they’re hypersensitive, you gotta send them to get treated. Again be careful with epileptics who need to withdraw slowly as it can lower that seizure threshold and precipitate seizure activity.
So first of all for now we’re going to just summarize CBD since that’s what we just talked about with Epidiolex. Favorable safety, no risk for abuse or dependence, maximum doses are listed here under Epidiolex labelling under 1,400 milligrams a day. And then these are the most common adverse effects in clinical trials.
So then Sativex, is combining both of those because it’s a 1:1 ratio combining THC and CBD, so think about the safety profile between Marinol and Epidiolex and you’ve got the safety profile for Sativex. Mild to moderate side effects and severity, no serious adverse events were considered to be statistically significant in these studies. Most of these adverse effects were considered to be mild to moderate.
So now we’ll go into the benefits for pain. So this first systematic review was basically looking at 28 studies, ok? And these were looking at both smoked THC or Sativex when they looked at the review. And what they found was that or what they concluded is that there are moderate or there is moderate quality evidence to suggest that cannabinoids may be beneficial for the treatment of chronic or neuropathic pain. This other system review from 2017, essentially what they did was they added two additional studies that the previous review did not include, and concluded themselves that there was substantial evidence that cannabis was effective for treatment of chronic pain in adults. So they’re speaking specifically to cannabis which means they’re talking about both THC and CBD.
There are primary research studies. Ok, so these primary research studies. This first one was looking at varying levels of THC for diabetic peripheral neuropathy. They had low, medium, or high THC levels. And then they were measuring pain over four hours. So more of a fast response. And they concluded that dose dependent reduction and diabetic peripheral neuropathy spontaneous pain readings occurred. The second primary study was another randomized placebo controlled trial looking at placebo versus low and high what they call high dose THC’s. And they found that cannabis reduced neuropathic pain scale readings. So these are two primary research studies, randomized controlled. And then clinical reviews. We’ll end by talking about what they found. So this clinical review by Hill in 2017 states there is conversion evidence to support the notion that cannabis can produce acute pain inhibitory effects among individuals with chronic pain. And then the one two years earlier concluded that chronic pain, neuropathic pain and spasticity associated with multiple sclerosis are the indications for medical marijuana supported by high quality evidence. So, high quality evidence as of 2015, was determined as available for these three conditions listed there.
Dayton from Minnesota. So our neighbors to the north whose program is three years ahead of ours approximately. Again, what they did is they took survey data from patients under the condition for intractable pain from August 1st to December 31st of 2016. So there’s 2245 patients enrolled, they were enrolled for these common conditions: axial back pain, ridicular back pain, fibromyalgia, neuropathy and osteoarthritis. Those were the top 5 conditions patients were certified for. They sent survey data out to all of these patients. 54% of patients responded back, 40% of healthcare practitioners who are certifiers for this condition responded. So basically the way that their scale works is high level benefit is based on a number 6 or 7 on a 7 point scale. 61% of patients reported high level benefit, or 43 practitioners stated high level benefit. Little to no benefit, meaning a 1 2 or 3 scale, was 10% of patients and 24% of healthcare practitioners. And a reduction in pain severity was the most common reported benefit in 64%. Here’s a pictorial representation of that. As you can see the top boxes here are showing the patient responses and the bottom is the healthcare practitioner. For the most part the benefits of the right half of the chart is showing higher numbers although it’s higher on the patients end compared to the provider end.
So summary of benefits. It is widely accepted that cannabis has efficacy for pain. The systematic reviews and clinical reviews presented have all reached that same conclusion. Based on reports from Minnesota patients and healthcare providers are also reporting reduction in pain. And then expert opinions are finding pain reduction in their practices and basically both states have substantial benefits from patients with pain.
So a big question that’s out there on what to do with patients on opioids. Obviously as pain physicians we see a lot of patients are on opioids. So how can we utilize medical cannabidiol in concert with patients on opioids? Is it safe, is it not safe? What should we be thinking about. So it’s important to understand the critical view of the situation. So as of 2017, 115 Americans overdosed per day on an opioid. And this includes prescription analgesics, it takes care of fentanyl. Four to eight percent of people who misused painkillers transitioned to heroin. Interestingly from 2013 to 2017 there’s been a national decline of 22% in opioid prescriptions. However, there’s been an increase in opioid related deaths and overdoses during that same time. Ok? What we’re finding is that deaths from fentanyl and heroin have skyrocketed in the time that the opioid prescriptions have declined. Ok? Fentanyl is going to be the big problem and the big cause of death. In the past 50 years fentanyl use has escalated. Fentanyl is 50 to 100 times more potent than morphine. Fentanyl is typically provided for acute pain controlled for post-surgical pain or for end of life or terminal pain. Ok this is not as an injectable form this is not an everyday medication people should have, and the problem is that car fentanyl which is coming illegally from China, is even more powerful. This is an elephant tranquilizer. And I spoke with a naturopath who does addiction medicine as well who basically says, think of the size of the grain of salt. Salt crystal. That could be enough car fentanyl laced within these opioid or heroin products that is enough to kill. So a lot of people using these heroin products don’t know that there’s car fentanyl within it and that’s why we’re getting a lot of unexpected overdoses.

So because of the opioid situation the CDC came out with guidelines, ok. The guidelines were there to help guide healthcare practitioners specifically primary care practitioners in the outpatient setting who treat patients with chronic pain with opioids. And what the CDC did is they said, use caution, if you’re oral morphine equivalent doses are above 50 milligrams per day. Use extreme caution if you’re using more than 90 milligrams of morphine per day. American Academy of pain medicine has concerns as many primary care clinicians may interpret these as may interpret these as thresholds or ceilings. And what I see in my practice is sometimes patients come in saying my primary care provider is refusing to prescribe any opioids because they think they could get in trouble. So, what we’re seeing is these levels might be seen as caps. Patients who may be benefitting on higher doses of opioids that are stable and showing functional benefit might be leaning down with having increase of pain, and we’ve potentially swung the pendulum pretty far in the other direction. So, being on the front line, this is something that we’re seeing, and you know I would say it’s a frequency that we’re seeing this.

Dan Moys: Dan Moys I work with Jolene, one of the pain docs in town. I wanna add to this new legislation that was passed by Medicare at the center for CMS. Starting January 1st of 2019 in the United States of America, uh, Medicare is adopting these rules. So Medicare is setting a limit of seven days of pain pills for new opioid patients. And they are shooting for a 90 morphine equivalent cutoff. There will be an opportunity for a soft edit where you can talk to a pharmacist up to 200, um, but when medicare is adopting this Medicare actually wanted a three-day script, a max three day script. What that means for the healthcare system, I don’t think they understand the ramifications. When you have surgery, elective surgery, you’re not taking pain pills, that means you’re getting seven days of pain pills. Ok, so if you have your knee replaced, you’re getting seven days of pain pills. What happens if you need more pain pills? You gotta go back and see a provider. You can’t call it in. You gotta see someone. A lot of insurances are making you document that you had uh, a urine drug screen, all of these things in order to get your pills filled and paid for. So there is increasing legislation that all these numbers, important for you to know here, all of these numbers come from the Centers For Disease Control paper from 2016. There’s a lot of controversy about this. But you see, insurance companies have latched onto these numbers, and like Dr. Smith is saying, this is what we’re seeing on the front lines, is, there’s hard numbers. And insurance companies have picked up on this too. United Healthcare, you have to fill out extra paperwork if you have someone over 90 morphine equivalence. They may have been on it for twenty years, but they are basically forcing people to come down. For better or for worse, there’s some controversy, but they are eliminating high-dose opioids, which we all know, higher dose opioids, you know, the danger, the risk goes up. And that’s very well quantified in a lot of data out there. But they’re gonna, there’s increasing legislation – Wal-Mart will not fill out more than 50 morphine equivalence for a prescription period. So there’s surgeons telling patients don’t go to Wal-Mart if you’re having surgery and you’re getting your pain pills filled. So there’s different, it’s coming from all angles, from the insurance companies, from Medicare, which isn’t an insurance company but is from the government, and also from pharmacies. And this is being extrapolated to the providers. And we see a big dichotomy, the younger docs, they just don’t write opioids. They’re raised in this culture that we’re in and what’s going on, and they just say, we don’t want to do this. It doesn’t work. The older docs, generally they were practicing in the day where you could be sued if you didn’t treat people’s pain. Big vital sign. Ok. So you gotta treat people’s pain more and more and more. And so there’s, it’s very complicated, but we’ve seeing more legislation passed, and I think just going on this, sorry to interrupt.
Dr. Smith: Yeah that’s great points. Um. So, you know, we can’t say cannabis, cannabidiol, is the thing that is going to be the cure, the problem eraser of this opioid problem. However, studies and data have shown that in certain subsets of patients this can be efficacious as an adjacent in helping lowering opioid requirements or even eliminating opioid requirements. The safety profile of CBD and cannabis versus opioids is profound, ok, so there’s more favorable safety profile for cannabis compared to opioids. And that’s pretty clear in the research. So, two studies recently published in JAMA, looked at the association between legal cannabis and medical cannabis in the reduction in opioid prescriptions. So, prescriptions for all opioids decreased by 3.7 million daily doses per year when a medical cannabis dispensary opened. 5% decrease in all Medicaid coverage in opioid prescriptions in states with medical cannabis laws. 5% was in Schedule 2 prescriptions and 10% was in Schedule 3 and 4. So when there’s a law that when there’s a dispensary, there is a reduction in opioids. So, survey data from Minnesota. Over the past six months, this is a question that they come up with, over the past six months has this patient’s use of medical cannabis assisted in reducing dosage or eliminating other medications used for pain? This was going straight to the healthcare providers. 58% indicated a reduction in pain medication, ok, so the rest said no reduction. 37% of that reported a reduction of that medication was an opioid. Of that, almost 50% of them reported that that opioid was reduced by at least 50% or more. Ok? Based on expert opinions, again, um expert in Canada, experts in California who are big on papers and have done a lot of their own primary research. Um, so, interestingly, so Canada currently, the cannabinoids are listed as third line treatment for neuropathic pain. So this is behind gabapentinoids, tricyclites, SSRI’s and opioids. These guidelines, four years old. So the Canadian pain society is currently considering whether to basically change their opinion on cannabinoids. Should it be first line or second line? Clearly there’s a better safety profile compared to opioids, and the way the guidelines are, they’re requiring somebody to try an opioid before a cannabinoid. Seems silly to the experts based on risk profile. Dr. Ware, again in um, Canada, does have patients on both opioids and cannabis. He says it’s ok to co-administer, ok, typically the protocol is if you’re co-administered the goal is to pressure down the opioid. You should be considering a dose reduction of opioid, or even an elimination of an opioid in his practice, if you’re co-administered cannabinoids. Again Mark Wallace out of UCSD, same opinion. Basically in his practice he’s finding a tapering of 80% of his patients on opioids when cannabis is introduced. Higher CBD in the day, higher THC at night helps to prevent that somnolence in the daytime and awakeness at night. So that’s his practice. Again these experts too they say start low titrate slow. Iowa law. So this is kind of the meat of what all of what we’ve presented now, we’re going to transition and talk, how does that impact us. So, looking at other states now, Colorado and Oregon, and we can assume other medical states where cannabis, other states where medical cannabis is allowed, severe pain, number one certified condition. By a lot. Ok? The Iowa definition, so currently our Iowa cannabidiol certifying conditions states, and this is directly from Iowa House File 524 – the things I emphasize are for my own personal emphasis not emphasis within the actual document – so untreatable pain. Means any pain whose cause cannot be removed, and according to generally accepted medical practice, the full range of pain management values appropriate for the patient has been used without an adequate result or with intolerable side effects. Ok? Untreatable pain, full modalities have been tried, no results or inadequate results.
Let’s now compare that to the Minnesota definition for pain. So, intractable pain means a pain state in which the cause of the pain cannot be removed or otherwise treated with the consent of the patient, and in which in generally accepted course of medical practice no relief or cure for the cause of pain is possible. Or no one has found after reasonable efforts. Reasonable efforts are listed here below. Ok? Now let’s compare and contrast these two definitions. Minnesota, intractable. Definition from Webster: “Hard to control or deal with.” Iowa, untreatable: “No medical care is available or possible.” In my opinion, the Iowa definition is both nagless and an oxymoron. Also what does the full range of pain management modalities actually mean? And, does our clause eliminate the patient’s consent? So what if a patient does not want to wish, or does not choose or want to be prescribed an opioid? Ok. Does that automatically disqualify them, because you haven’t tried something that is considered a viable treatment option? Under the Iowa law that would disqualify that. So, I would like the Board to consider clarifying Iowa’s definition of pain and aligning it more closely than that of Minnesota. Pain will be the most common reasons that patients seek certifications. Physicians need a clear definition to feel comfortable in providing a treatment course for our patients here in Iowa. So, again, by certifying a patient for untreatable pain, I am essentially saying that there is a treatment. Ok? I am wanting to treat my patient’s pain with cannabis, but they are, I am wanting to treat an untreatable condition. So you see by checking that box you are basically saying that there is a treatment. That you want them to be treated with cannabis. So, I really, at the end I’ll conclude, I really want this to be considered for legislation to really clarify it on the front and ask somebody who has certified patients.
So inhalable forms, and this is just a comment from me, currently not available in Iowa. But understanding that there is a higher bioavailability than oral, meaning a faster onset of action, could become a question as to what are we treating? Do we wanna treat a condition that requires long acting, or, do we want a short acting version?
Useful conditions. So for example, trigeminal myalgia. An extremely difficult condition to treat. Often presents with lancinating facial pain that comes on like a stroke of lightning, ok? Taking an oral based form may not provide the appropriate relief for this type of painful condition. So as we move forward, and as we transition into the beginning stages of utilization, in the future I would recommend considering some type of an inhalable form, as some kind of fast acting or rapid treatment for these rapid occurring pain states.
The other thing to consider is some of these patients aren’t able to swallow pills. Multiple sclerosis, ALS. What options are we going to have for them if they can’t swallow a pill outside of sublingual? But again, quick acting, something to consider would be inhalable.
The other thing that we don’t have, and to my knowledge, no other states really have this clause, and something that we would all, or myself, and in speaking with the experts would like something to be considered but, add a provider withdrawal certification. So, currently we certify that patient has their medical marijuana card for a year. Ok, there are many reasons that could occur over that year that means that physician would not want that person to utilize cannabis. Has abuse become a problem, have they developed heart problems where it would be unsafe, is it not working? Ok. There are many many reasons where we have no control once we certify a patient for an entire year. Ok, so those were my main points that I’d like to focus on so far as Iowa. So let’s just now conclude what we’ve gone through throughout this lecture. So cannabinoids show efficacy in treating pain in some patients, particularly when looking at studies that have shown THC alone or THC in combination with CBD. They may assist patients in combination with other medications, including opioids. And to really drive home the point Iowa in my opinion should consider clarifying the definition of pain. I would recommend considering to be more in line with that definition from Minnesota. In the future as a program develops consider inhalable forms for the reasons I mentioned. I would recommend in Iowa we collect data. We collect survey data because Minnesota has a robust survey response rate, and to follow how our patients are doing, will ultimately help us in Iowa make better decisions, and maybe identify additional qualifying conditions that are not being covered under what we currently have. And then again considering the ability for providers to withdraw certification, at intervals throughout the year of their eligibility card.
A lot of references here at the end. What questions does anybody have?
Carl Olsen: What’s the dependency liability on opiates, you showed the alcohol and the cocaine and the nicotine.
Dr. Smith: 9% is what the study shows.
Carl Olsen: What about the opiates?

Dr. Smith: Oh, the opiates. Yeah. I don’t know that number off the top of my head.

Carl Olsen: So high it’s probably –
Unknown man: Yeah I mean it doubles in how you define it and uh, you know, everything is, those are, gross extrapolations from small studies, it’s a huge problem, little of that number. I wouldn’t say it’s higher than 20% but it’s probably above 5%.
Woman: And you did mention that 4 to 8 percent of people that take prescription opioids did go on to —
Dr. Smith: Transition to heroin.
Woman: — transition to heroin – so that gives you kind of an idea.
Dr. Smith: Yeah. Unfortunately I’m not an addiction specialist so I don’t know that number off the top of my head.

Woman: I just want to make one clarifying comment about Iowa’s law. With respect to um, the definitions. So for our law, you’re not required to show untreatable pain if you have cancer or a terminal illness, the definition there is for severe or chronic pain, so I just want to make that distinction.
Man: We’ve talked about this a bunch. You know there’s a CPT code that intractable back pain, intractable pain. There’s no CPT code that’s acknowledged by payers for untreatable pain, because there’s usually always something we can offer. And that’s why, if you look at the regularity of this, that’s something that we want to practice having in the space of medicine. Clarifying that is more in line with what I think medical terminology, why we’re doing that. Um, and that’s, we’ve had some discussion about opioids too. There’s no evidence that opioids are effective over twelve weeks. Ok if there is tough for Due Pharma, they want to know it right now, ok there’s not, and yes we write opioids on a daily basis. It is a, as long as we’re having surgery, we’re living longer than ever, we can do heart transplants, liver transplants, we still can’t do back transplants, ok. And as long as we are doing surgery and we live longer and longer pain will be continued for a basic part of our existence. Chronic pain is about a $650 billion a year. That’s more than than cancer, heart disease and diabetes combined. And that number is going up. We need to offer patients alternatives. And we want to make this very clear that we are not anti-pain pill we’re not pro-pill pill. We’re pro-patient. We’re not anti-marijuana, we’re not pro-marijuana, you know we are pro-patient. And looking at the data, giving patients alternatives and evidence-based options. And just promoting dis of all the stuff.

Woman: Can I point out one issue. It’s hard for us when we’re keeping minutes to capture comments from the public, so we have a section on the agenda for public comments, if we could confine it to your presentation then questions from the board and then any comments can certainly be made during that public comment period, that’s just a lot easier for our minute taker.
Dr. Schreck: Dr. Smith this is Dr. Schreck can you hear me?

Dr. Smith: I can. Hi Dr. Schreck.

Dr. Schreck: Couple questions. You yourself prescribe Marinol for pain.

Dr. Smith: So, right now we don’t treat the FDA indications for Marinol, and it’s too much of an issue of getting prior authorizations for everything else that we treat in regards to pain, so no, to your answer.

Dr. Schreck: Use a legal optical for doing so?

Dr. Smith: A legal?
Dr. Schreck: I’m asking you as a doctor for a legal opinion.
Dr. Smith: Oh.

Dr. Schreck: We prescribe lots of medicines. That’s what the person (can’t understand).

Dr. Smith. Sure I don’t see a legal problem, it’s more of an administrative challenge when discussing prior authorizations and the difficulty we have with things like Lyrica that we’re using more frequently. But I have had patients who are on it, typically prescribed by, often times oncologists which is what you are, for helping with nausea and vomiting. So I have had patients on it, um, but typically it’s not something that I bond to. The other problem is if it’s an uncovered service or if it’s off label, often times insurances are not covering, so often times it becomes a financial burden to the patient. Even with Lyrica, which is listed for postapetic neuralgia, for patients with post Lyrica Tami pain or other neuropathic conditions, we’re not getting it covered and it’s hundreds of dollars out of the pocket. So the cost becomes an issue, you know, on the front line when trying to utilize products that are off label.
Dr. Schreck: All of these products out of Iowa will be out of pocket cost as well.

Dr. Smith: Correct.

Dr. Schreck: I haven’t to look at the out of pocket cost of applying Marinol around insurance companies out of pocket.
Dr. Smith: Neither have I.

Dr. Schreck: Thank you.

Woman: Thank you for the comprehensive conversation.

Dr. Smith: Sure.

Woman: Since we’re talking, since you mentioned using the word intractable, which, I like that, as well, what do you think about including the term compassionate in here? The reason that I’ve sort of pushed for that is that I feel that when we’re using something off label, when you add that term, it suggests to me that everybody understands that you’re using something out of compassion.
Dr. Smith: Yeah, I, I, I mean to Dr. Moys’s point, in our practice we’re there to treat the patient. You know, knowing that every patient is different we are pro-patient. And if being compassionate for a condition on the front end is difficult to manage, I’m all for adding that verbiage to the definition. I like that as well.
Man: What other clarifications? The rules do allow for a nebulizable inhaled form.

Dr. Smith: Correct.

Man: So that could be developed. Could you please talk a little bit about the difference between delivering it in a vaporized form versus whatever a nebulized one might be?

Dr. Smith: So often times when we’re talking about inhaled we’re considering inhalers. So each inhaler puff has a very limited ability to direct a large amount of medication. For example, one inhalant may contain one gram. That means thirty milligrams THC per nebulizer. That’s typically 200 puffs to get 30 milligrams. Some of the data is showing patients requiring 130 milligrams per day. So an inhaler, as in what an asthmatic would use, are also very expensive. So potentially you could be doing 200 puffs times up to three inhalers per day. So an inhaler at the current 3% THC would be difficult. So as far as other vaporized forms such as a nebulizer, I can’t comment on how that would be able to be concentrated. But typically an inhaler form, which is the vaporized form that we have, doesn’t seem to be very feasible for what most patients would require in a day.
Man: So what about the mucal spray that Sativex has, what would you define that as, would that fit under nebulizable?

Dr. Smith: Well I think that’s considered a
Man: Cause it’s not vaporizing it, it’s actually a –
Dr. Smith: Right.
Man: It’s not heating it.

Dr. Smith: What was that? Sublingual I think, so yeah, rather than inhaling it into the lung, it’s going through –
Man: Ok.
Dr. Smith: Yeah.
Woman: Are there more questions, or? Thank you.

(Applause)