The Drug Report

Understanding Drug Scheduling: Marijuana Rescheduling, Safety Concerns, and Public Perception

SAM & FDPS Season 1 Episode 32

Join us for this audio version of last week's zoom webinar on rescheduling,  a deep dive into the intricate world of drug scheduling and addiction with our esteemed guests: Kevin Sabet, President and CEO of SAM, CADCA  policy consultant Sue Thau, and Dr. Russ Kamer. We kick things off by breaking down the history and impact of the 1970 Controlled Substances Act, using relatable analogies to dispel common misconceptions about drug classification. This sets the stage for a compelling discussion on public perception, medical use, and the complexities of drug policy reform.

Get ready for an eye-opening analysis of President Biden's efforts to reschedule marijuana. Starting with a review by the Department of Health and Human Services in October 2022, the process reached an unexpected climax in August 2023. We dissect the irregularities of potentially moving marijuana to Schedule 3 and consider the implications for tax obligations, FDA oversight, and research opportunities. Our panelists bring their unique perspectives to unravel the complexities and uncertainties surrounding this significant policy shift.

Public safety and health implications of rising marijuana use are our final focus. Learn how marijuana's prevalence compares to alcohol and why it's crucial to address misconceptions about its safety. We delve into the challenges of measuring marijuana impairment and emphasize the urgent need for reliable testing methods. With insights from Kevin Sabet, Sue Thau, and Dr. Russ Kamer, we encourage you to engage thoughtfully in the regulatory process and consider the broader implications of these monumental changes in drug policy. Tune in and stay informed!

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Speaker 1:

Yes or no? Do you believe nicotine is not addictive?

Speaker 2:

I believe nicotine is not addictive.

Speaker 3:

yes, Congressman, cigarettes and nicotine clearly do not meet the classic definitions of addiction.

Speaker 4:

I don't believe that nicotine for our products are addictive. I believe nicotine is not addictive. I believe that nicotine is not addictive. I believe that nicotine is not addictive.

Speaker 3:

Well, hello everybody. I hope everyone is doing well. My name is Kevin Sabet. I'm the president and CEO of SAM and joined by a great group today. We're very excited to get started here and we have over 500 registrants, so that's why we waited a few minutes and I'm sure others will continue to come on Obviously a lot of interest in this area. What we kind of thought was I'm going to present some slides just to kind of set the conversation and then, you know, we have such an illustrious panel here, joined of course by our FTPS co-founder and SAM's executive vice president, luke Neferato-Suzan. We're also joined by Sue Thaw, who I think everybody knows needs no introduction. She's the public policy consultant for CADCA and has been in this field almost four decades now. We're just lucky to have her experience and expertise Incredible, to think about that. And also Dr Russ Kamer, who I think most of you know and is doing incredible work with the ISIC group. He's a clinical associate professor at the New York Medical College and was actually the drug testing crew chief for the NCAA and the doping medical officer at the 96 Olympics, which I didn't know about the Olympics, maybe I forgot Russ, but pretty neat. He also co-founded Partners in Safety, occupational Medicine and, like I said, is part of the expert physician council for the International Academy for the Sciences and Impact of Cannabis, iasic, which I encourage you all to check out as well.

Speaker 3:

So I'm going to be sharing some slides here and I think what we'll do again, I really do invite all of the panelists here to interrupt. I think we should just kind of do this in a way that isn't very formal, and so I'm going to present some slides and if there are things I'm missing or things you want to add, just please get in there. And then for the participants here because we have, you know, several hundred, obviously on please, you can, I think you can type your question in, I believe, on the Q&A, so please do that. We should just know as well that there are several media outlets on this is open press. There are people with diverse opinions, diverse points of view and probably diverse funding sources that are on this webinar right now. So just keep that in mind, but we're very happy to have everybody because we're really putting it all out there on this issue. That, I think, is extremely comprehensive and also, I think, extremely misunderstood as well, which I think we're going to talk about some of that right now. So let me go ahead and start scheduling. Probably you can see my slides, I hope. If not, let me know. So let's talk about I'm going to minimize the screen here. Let's talk about the schedules here.

Speaker 3:

I mean, you know, probably most people understand that the DEA has classified controlled substances into five categories that are distinct depending on two criteria that Congress came up with in the 1970 Controlled Substances Act. By the way, just a little bit of now that I have so many hundreds of people on here, I get to get on the soapbox a little bit. I guess what's interesting about the 1970 Controlled Substances Act is really if you look at it historically, it was actually seen as a drug reform, meaning a less conservative drug law than was already on the books. In the 1950s we had mandatory minimums, federal mandatory minimums for all drugs, including marijuana. That was a part of the Bob's Act, and what 1970 did interestingly was actually reform that and change the way we look at drugs. And it wasn't until the mid-80s, with the Anti-Drug Abuse Act, did we get mandatory minimums back.

Speaker 3:

So I think a lot of people think about the Controlled Substances Act as some kind of extra punitive measure. In fact, historically, if you look at it, it was actually a non-punitive measure. It was a reform from the previous punitive measures. But anyhow, what it did is it classified drugs into five distinct categories, or scheduling, and what I think, people, is the biggest misconception. You can read what the drugs are there, but what the biggest misconception is that if two drugs are in the same schedule then we think about them as equally harmful, and that's actually not at all what the scheduling is. The scheduling just simply means that if you fall under these two categories of acceptable or accepted medical use and, depending on your abuse or dependency, potential sort of a range there, and if you fall into that, you're in that schedule.

Speaker 3:

So I use kind of maybe a stupid analogy when I talk about this, but I talk about, like the snack aisle at a grocery store. The snack aisle at a grocery store. The definition of that aisle let's say it's aisle three is snacks, and maybe the definition to the manager means snacks that are sort of one to two per person, sort of take home, that are sort of one to two per person, sort of take-home, ready-to-eat snacks. In a ready-to-eat snack aisle you can have banana chips, you might have cut-up apple slices, you also might have Doritos and Oreos. It doesn't mean that Doritos and Oreos are the same thing as the cut-up apple slices. It means that they both fall under this criteria sort of arbitrary criteria but it's a criteria that someone made up. It's a natural law. But somebody made up criteria based, hopefully, on science and, in this case for the grocery store manager, maybe based on something related to, you know, the science of how people shop. And that's how they did that.

Speaker 3:

And so when heroin and marijuana are currently in schedule one, it doesn't mean that the government thinks that marijuana is as dangerous as heroin. It doesn't mean it thinks marijuana is as dangerous as LSD or whatever it is. It means that they fall under the criteria, and the Schedule 1 criteria means it's a drug that has no accepted medical use and a high rate of abuse. Now, traditionally the accepted medical use would mean that it doesn't have an approved medical use and that's a really key distinction. That was never a real distinction before. But FDA, in this latest scheduling recommendation they've made the distinction between accepted and approved and I'll get more into that later. But that's a really interesting distinction that's never been made before.

Speaker 3:

Schedule two substances are plenty dangerous but they might have some accepted medical use. So if you have any accepted medical use, you cannot be in a schedule one. You have to be in two or lower right. And so fentanyl patches have been used in hospitals for decades. It doesn't mean that we think that fentanyl is somehow less dangerous than marijuana. It means that fentanyl is schedule two because it has some accepted medical use, still has a high rate of abuse, so it should be scheduled two, and then so on and so forth in terms of as you go down, but if you have no accepted medical use, you have to be in Schedule 1. All right, and so you think about some other drugs, for example in Schedule 2.

Speaker 3:

And for those that raised hands, I think we'll do questions at the end and then we'll just leave the panelists open here to chime in. But for Schedule 2 drugs, you have drugs like Adderall, methadone, fentanyl, but you also have things like poppy straw, opium straw. And what would poppy straw be used for? Why is that Schedule 2? Well, that's Schedule 2 because the concentrate from poppy straw is used in opiates that we use for medical purposes. So actually poppy straw is, even though it's itself not necessarily a drug, that you can go buy and get poppy straw from a CVS pharmacy, but its concentrate is what you use, so it's pure form, is what's medical. So it has to be scheduled too.

Speaker 3:

But again, this is really the key point about scheduling. That's very important. And then you go down the list, of course, with Schedule 4 and 5. And then of course you have uncontrolled substances. I mean, congress did not write in alcohol or tobacco in the Controlled Substances Act. Now you may say, well, why didn't they? Well, because culturally we made a decision after Prohibition really to leave most of alcohol regulation to states and you know to have some federal oversight. But frankly, very little. And tobacco now is by special statute, is controlled by FDA, but that's fairly recently, before it wasn't. That doesn't mean again that we think that the macro effect of alcohol is somehow less dangerous than the macro effect of a Schedule 5 drug. Of course not. But that's just the legal decision and definition that's been made. So alcohol and tobacco are not included in the CSA.

Speaker 3:

The scheduling of marijuana Now, marijuana has long been in Schedule 1. It's only ever been in Schedule 1. It's not uncommon. Over the last 30 years We've seen many challenges to that scheduling. Okay, this was actually a fairly good, I've got to hand it to him PR mechanism. In the beginning it was by normal. Normal, the National Organization for the Reform of Marijuana Laws, was once the most prominent marijuana organization in the country. It's a shell of what it once was. It's completely interestingly. As legalization has increased in popularity, these organizations have totally been diluted, um, by the industry, so they're much less relevant than they used to, but they used to be quite relevant in the 70s.

Speaker 3:

They multiple times they challenged this and it got them headlines, it got them in the news, it got it made the government review this over and over again. It was a, it was a tactic. They they used to do this through this bureaucratic act of Congress which is the second bullet there. They couldn't do it through Congress, so they had to do it through the administrative process here. And anyway, the last time this was looked at, other than the time that we're looking at it now, was when President Obama somebody President Obama somebody, a group of medical marijuana advocates petitioned the DEA to look at it again, and so President Obama's administration looked at it Chuck Rosenberg actually was the acting administrator for DEA and they did a very thorough review and, of course, once again found it doesn't have accepted medical use and it has a high abuse potential.

Speaker 3:

So there's no reason why it shouldn't be in Schedule 1. Now again, congress can change these schedules anytime. We've actually advocated for a reform of the schedules because we do think that there are some things where you could add a research schedule to increase the research. I'm going to talk a little bit more about increasing research in a minute, but there were a lot. There are a lot of things that that you know Congress could do if they wanted to change a controlled substances act. I don't know if anyone else wants to chime in on anything I've said so far, or we should keep going.

Speaker 1:

Keep going.

Speaker 3:

So in October of 2022, you know, president Biden, let's just back up he promised on the campaign that he wanted to reschedule marijuana, to schedule, to talk about that kind of seen as a compromise between full legalization and doing nothing. Ok, so, after some other pardons and other actions, in October of 2022, the president initiated the process. And, by the way, the president initiated the process and, by the way, anybody could initiate the process, but this time it happened to be the president that initiated it. Okay, so people will listen. Probably It'll be done faster, probably right, which, by the way, it's been much faster this time than it ever has been. So, clearly, being president certainly counts for something in this. He initiated this process as the administration did for something in this. He initiated this process as the administration did, which meant that the HHS first had to do a review of the marijuana schedule. And they did a review and, interestingly enough, on August 30th at 4.20 pm, which was probably not a coincidence the Department of Health and Human Services said that they have transmitted their recommendation to DEA, because first HHS has to look at it, then DEA has to look at it. And I will tell you, as somebody who's served in three different White House administrations.

Speaker 3:

The public announcement of this was really surprising. I couldn't believe it, to be honest, and I knew from then on I was sort of holding faith that there would be a normal process and there wouldn't be anything different. But I knew from the minute at 4.20 pm on August 30th 2023, that this was an unusual process that was about to be unfolding. And boy was I right, and was so many other people right, because to publicly announce that is a very weird thing. Also, to not share your recommendation but publicly announce that you have a recommendation is a very weird thing. And so I knew that the government processes for this. They were not the normal processes. I probably got a hint about that when I found out that the FDA brought in a lot of new people to do the review. That process has been very much behind closed doors, but from what we can decipher and put the puzzle pieces together, it was interesting that you had new people, including somebody who was the marijuana czar for two states who just was all of a sudden recruited by FDA. So there were definitely changes. Things didn't smell the same way as they did before, so that was done and basically four months, they finally had to release an unredacted version of this recommendation.

Speaker 3:

Um, and that was actually done by a uh you know, uh sort of somewhat pro-cannabis lawyer who said wait a minute. And he was right. I mean, we were totally in agreement. How can you announce this, not even tell us what you're doing, and yet you're announcing it on twitter, like what you're announcing something on twitter, but not the whole picture. So he, he actually sued HHS and before that lawsuit could go forward, it would take too long. They basically relented and said, okay, okay, yeah, we probably botched this, go ahead. Here's our version. Here's what it is. So it was a 252 page review. Now we've gone through this review. If you're interested in our take of why FDA went there, you can scan to review the full rationale.

Speaker 3:

But I really couldn't believe what an exercise in cherry picking this recommendation was. If this was a dissertation, a PhD dissertation, it would have failed at first blush. It was incredible how this was basically fitting a square peg in a round hole, and I'm not necessarily blaming FDA, because I think they were put in there, for you know, there were political, obviously political reasons. I mean, this was a campaign promise after all. So they had to figure this out and you know they were under pressure from legalizers to de-schedule it completely. Like they said wow, we don't want it to be in there at all. They were under pressure by a lot of people, but the reality is they basically said in 252 pages, one of the key points is that because marijuana is popular, it's accepted and so that means it has acceptable use. Now there's a little footnote in there that says we're not saying it's approved, don't think that it's, you can't get the prescription, don't think that it's approved, but we're saying it's accepted. And so for the first time ever that I understand, you have a drug that has accepted but not approved medical use. That's out of Schedule 1. It's unprecedented. They also did the way they did. The review in terms of the tests that they used was a test that they've never used. It was a completely new test, a new two-part test that they've never used. So there were a lot of irregularities here. Now what does this mean if it is happening? Well, it wouldn't legalize marijuana. It would not allow the prescription for marijuana because there's no approved medical use.

Speaker 3:

Frankly, the industry is kind of split. I mean part of them. They welcome this because they're going to be not subject to taxes as much. They're going to be able to deduct business expenses, like advertising expenses. But in reality, you know, some of them say well, wait a minute, does that mean we have more FDA oversight? What does this actually mean? Nobody knows what it means. I mean, you really you have no idea. I mean I can't imagine FDA's can all of a sudden exercise their administrative power that they haven't done you know ever on this issue and go and you know, force pot shops in Denver to comply with Schedule 3 requirements. But God knows what's. It's very actually unknown what would happen if this actually went through.

Speaker 3:

Now a lot of people and a lot of very well-meaning people and well-meaning organizations say you know, kevin, regardless of you know the headlines we're going to get that are going to confuse people completely about what this does, regardless of the tax rate, maybe this is good because we can do more research, and maybe there's just such a difference that we can do more research and it'll be easier to look at, and so it's true that research would probably be a little bit easier. But that's kind of like saying you know my car you know is going to be, you know, a lot safer because you know I changed one of my windshield wipers. Now it might be safer, like one of them might be bad, and so you made it. But if there are a lot of other problems with your car, you know the windshield wiper especially if you live in California aren't going to be that relevant. And what I'm getting at here is that funding is the number one reason why there's research into any drug, and I'm not sure moving into Schedule 3 is going to like.

Speaker 3:

All of a sudden, the clouds are going to part and the investment is going to fly from the sky in terms of a true pharmaceutical drug. For many reasons, one of which is why would you go to the pains of doing that when 40 states have just gone around the fda process and created their own drug themselves? Um, but, anyhow, we've made a grid. We have not publicly released this because we still actually have some people at dea looking at it, but basically, um, what's the difference between marijuana as a Schedule 1 and marijuana as a Schedule 3? The big difference is that the criminal penalties are generally unchanged, right? So you know, people, the way this has been touted by the White House is that all of a sudden, we're going to have, um, you know, like we shouldn't.

Speaker 3:

We have a failed approach to marijuana is what I've heard, or you know because of the criminal penalties and this is going to help people not go to jail. The criminal penalties are basically unchanged because marijuana is by statute in the Controlled Substances Act. Now there are some trafficking penalties that are like minor differences, not major ones, depending on how you read the statute, but bottom line is marijuana is in the statute not as a Schedule I drug but as marijuana, and so there's a very good argument to be made that none of these criminal penalties are going to change. Secondly, these are federal penalties, so I mean most of the penalties have been done on the state level, unless you're talking about, like the biggest drug cartels, which are, by the way, they're always charged with another drug anyway, and it's certainly not for personal use. So this idea that, like people won't be in prison and we'll, like we need to change our failed approach, it doesn't actually do that at all and that's probably my biggest pet peeve with this is that it's being touted as we'll have fewer penalties. That's not what scheduling does at all. So really, that's a key point. Business taxes will be deductible under Schedule 3. Not a good thing in my mind, a great thing in the industry mind. Of course, it does not allow a state for illegal use of the drug. It is not eligible for a prescription because it's not an approved product.

Speaker 3:

What about the research requirements? Well, you may not have to submit your research protocol to DEA immediately, but you're still probably subject to IRB approval. You still need documentation. You still have to keep inventory records. You know you are. Even if it's a schedule one drug, you can distribute drugs to other authorized individuals, so that doesn't change. The dea has to still be notified if you lose your drugs. Um, you know, you still have to maintain accurate records. You still have to maintain inventory. You have to do it in a different way than you would normally, but a lot of this stuff is technical. You still need to store your, your product, in a securely locked, substantially constructed cabinet. I mean, this is how detailed we're going into. You don't need a statement of it, but you still need to do it. So you need a lot of.

Speaker 3:

There's a lot of things that actually don't even change when it comes to research requirements, and yet I think people have been duped into thinking that overnight the research is just going to fall from the sky because it's so much easier. Is it somewhat easier? Yeah, you can argue it's somewhat easier. That's good, but you know you don't need to to to total your car if just the windshield wiper is broken, like there are ways to fix this without completely changing what's happening and allowing industry to really invest in this more. And again, that's the medical side and research side. There's other slides we have on, but I do want to let the other panelists in here on why this is actually a drug, that under their they use the word abuse so that's their word in the statute but why you could argue that it's actually also one of the most highly abused drugs. It's actually the most common commonly abused drugs. For young people it's not like one of the most common, it's the most common right. One in three users have a use disorder. There's so many stats and so many things we can go with. When you look at the rates of substance use disorder in the United States across all age groups. Alcohol it's not scheduled for better or worse. That doesn't matter on that front, but I mean when you look at marijuana, I mean the idea that it's somehow less of a macro effect in the United States doesn't really make sense.

Speaker 3:

So where are we now? Well, there is now a proposed rule. They initiated this. There's what they call a Notice of Proposed Rulemaking NPRM that they've published on May 21st, and so this is now open for public comment. You have until July 22nd. You can only do it once After that comment period ends. And, by the way, if you want to know how to do it, we'll be sending out an email about it. We've already done that and we can talk about that. After the comment ends, the administration will analyze it, develop a final rule and then, of course, that can be challenged as well. So we're still, you know, kind of.

Speaker 3:

The process is far from over. Let's put now. They could speed the process up. They could say we're done on July 22nd and on July 25th we're going to publish the final rule and we're not going to allow any hearings on this. Goodbye, thank you. They could do that. The idea that there wouldn't be a hearing of course, this whole process has been completely irregular from the start, so I'm out of the business of predicting anything about it anymore. So, who knows, I would think they would grant a hearing, but we don't know. So we do encourage you to include your comments. We provided comments as well. Obviously, the industry and the legalizers have done so as well. They have a form letter. A lot of the pro-legalization groups don't like rescheduling because they want to see de-scheduling. They want it out of the Controlled Substances Act. They want to treat it like tobacco or alcohol, meaning it does not have those regulations. So that's something to remember. You can submit your comments there, go back to that previous slide real quick.

Speaker 1:

So one thing that's important to note is that the Drug Enforcement Administration, in their notice of proposed rulemaking, did something that is highly unusual, that indicated that DEA is really not on board with this rescheduling process. It's clearly a big debate right now at the administration, so what they did was, for each of the sections of this NPRM, they specifically asked for more data and more more, you know, writing on the concerns related to this change. You know. So what they asked for was more information and data and feedback on marijuana's potency, on marijuana's addictive potential, on the impact of the illicit market diversion, on the harms that people who who have a cannabis use disorder are experiencing, what those symptoms are like. They're asking for those things in the NPRM, so it's almost like they're giving a roadmap for how to rebut their own proposed rule, which there's a lot of political and a lot of thought around why that would be, but it's important. You understand that the DEA is asking for this information, and so we've had a few questions already about, you know, high potency marijuana, protecting youth. Those are all things that you should be including in your public comment. You can scan this, you know, to go to our page. We give you the feedback. Cadca also has an amazing write-up of comment as well. You can go to their website and check that out too.

Speaker 1:

But when you submit public comment, it's important to understand you only get one shot at it, once you submit it. You can't submit again, you can't redo it. So be thoughtful about how you're doing it. You know, put everything that you want to cover in there, and what I would say is you know, obviously we and CADGA have both provided form letters for you to use, with a lot of the data already there. That's great, but the most effective thing to do would be to include your personal touch to this. So, whether you have a story, whether you have other data that are not in there, so think of our form letters as just something to help you get started or at least give you things to think about.

Speaker 1:

But don't hesitate to remove those things and put your own information in in, because they're going to be looking for unique feedback. That's useful, and they are required by law to by federal law to look at all the comments. So there's 10,000 plus public comments already submitted. I don't know how they're going to go through that, but they are required to consider these comments. So really, really important that you do that and really important to understand understand. Da wants the information on potency, addiction, on the harms, of the abuse potential. So really you know those are some key areas to look at, yeah.

Speaker 3:

Great.

Speaker 3:

Thank you. I don't know if we need to go through all of this sort of why. Schedule 3, and I talk about a lot of this the analysis was different. They moved away from their normal test. There are some legal issues there. I mean, one of the issues is that we're subject to international conventions against drugs, which many people think that means we have to put including the federal court thinks that we have to put marijuana in Schedule 1, two to be in compliance. Um, you know, there are a lot of there are a lot of issues there. But uh, uh, you know they.

Speaker 3:

They totally changed the, the, the, the criteria, I mean the studies that they use to support medical use are a few very bad studies. Basically, literally a few very bad studies. Um, the standard has been totally changed, as I mentioned, um, and so it's basically just saying that if it's popular, then it's approved and then it's accepted. I should say, and so if it's accepted, it doesn't need to be approved. I mean, we've never heard something like this before. It basically means, I mean, look, if you're in the drug business, you should forget about the FDA process. You should absolutely just go to the ballot initiative process and then, all of a sudden. If you get 50% plus one all of a sudden, you should be considered approved. You should be off schedule one.

Speaker 3:

I mean, if I was an LSD, I'd be good. That's what I would be doing right now, which, by the way, they are doing right now. There's multiple States and voting on that, so it's very smart. I mean, that's that's the kind of thing that they are creating, which is really pretty amazing. When they looked at abuse potential, they basically did a cherry pick list of other drugs and said that marijuana is not as harmful as these, so therefore it can't be Schedule 1. Again, this is something that you could imagine a legalizer in their basement doing in 1978 know, in 1978, based on the research from that.

Speaker 3:

I mean, this is not 2024. This is not how it's done. This is not what it is. So there are a lot of things we can do, even if the administration agrees that after the notice, proposed rulemaking, there are legal challenges, congressional Review Act. We're looking at all of that right now, rest assured, and we assured and we're going to be maximizing this because we think Schedule 3 is really a bad idea and there are a lot of challenges that we are looking at. I don't necessarily need to get into details of all of that, so I do want to see what Sue and Russ have to add their thoughts on this, and then we'll kind of go through. We have a bunch of Q&A which we can all go through as well.

Speaker 4:

But, sue, did you want to add anything? I did. I wasn't sure how many people saw the American Trucking Association's letter. They are extraordinarily concerned because this basically takes it out of being a safety sensitive thing and they could definitely be liable if their truck drivers end up smoking marijuana. They wouldn't necessarily be needed to be tested anymore, getting a big crash and you know gigantic liability issues, gigantic issues with traffic safety, airline pilots and other safety sensitive jobs Schedule three you don't have to be tested for those. Anyway, so interesting that there's some unlikely allies in this that are very concerned and that have made their thoughts known. And I'll stop there and let Russ have his chance to say something.

Speaker 2:

All right, thank you, sue. His chance to say something. All right, thank you, sue, right? So number one, I wanted to talk about the difference between cannabis and cannabinoid medicines, because what this rescheduling does? They specifically talk about marijuana, meaning botanical cannabis, botanical cannabis, and now that's not a medicine. We do have cannabinoid medicines that are in circulation that have been approved either in the United States or in Europe, so that in small, defined doses, thc and CBD and a combination of THC and CBD are all approved medications. So these substances in small, well-defined, regulated doses, are medicinal.

Speaker 2:

The problem is that giving botanical cannabis I'll just say weed I sound like George Carlin. Weed is one syllable, botanical cannabis is about nine. It's weed. Weed is not medicine. It's from batch to batch, it's different. There's all sorts of different chemicals, different percentages, even if it's tested, when it's tested in medical so-called medical dispensaries, from one batch to another, one day to another, it's all different and that's not how medicine is prescribed. Medications have to be prescribed very carefully on a milligram per milligram basis, and you want to have a reproducible substance. So when you go back for your second prescription, it's the same stuff that's in your first prescription.

Speaker 2:

The other thing is in the definition, as Kevin was talking about how they tried to fit the square peg in the round hole, or as I learned from lawyers that their whole analysis was pretextual right. This is a pretext for legalizing and scheduling botanical cannabis, because they changed the definition of what currently accepted medical use is. Currently accepted medical use used to mean FDA approved or similar, having the same criteria. Instead, what HHS came up with, as Kevin said, if it's popular, you know they're doing it. Everyone else is jumping off the Empire State Building. We're going to jump off the Empire State Building, but it's even under their definition.

Speaker 2:

They fail because it's not widespread. They said that this is HHS's own justification that 30,000 providers across the United States are certified to recommend marijuana and that may sound impressive until you consider there are over 1 million physicians and that doesn't include the other providers who are allowed to authorize you, such as physician assistants, nurse practitioners, dentists, podiatrists, veterinarians and other people dentists, podiatrists, veterinarians and other people. So if you do the math, those who are authorized to recommend marijuana, it amounts to 0.3% of the providers. So that's not widespread. That is a small minority. In Colorado they keep good statistics on who is writing certifications and how many certifications they write and if you look at their numbers you find that the top one-tenth of one percent it's only one-tenth of one percent of providers are writing the vast majority, about 75 percent, of the recommendations. So again, it's not widespread. One other thing I'll mention, since I'm really a primary care provider and Dr Kammerer, that's a fantastic point.

Speaker 1:

I'm hoping you guys put that in your public comment. I'm assuming you did.

Speaker 2:

Yes, thanks Lou. Very good, and any other doctors out there.

Speaker 1:

Please feel free to bring up that point again. That's an excellent point. To bring up that point again.

Speaker 2:

That's an excellent point, right, and that's one good thing. Colorado was an early state. They did put that into their laws that they have to compile these things. So as far as doctors out there and I'm really a primary care doctor, I've done all these other things I can still consider those sidelines because basically I'm an internist and in my practice, like this morning for example, this is a problem when marijuana sort of indiscriminate raw crude cannabis preparations are now considered medicine and like a 74-year-old woman this morning said that her friend in Florida sent her some gummies and one's 10 milligrams and one's 25 milligrams that's really the dose and that she starts taking them every so often at night. Now she's a little confused to start with. Maybe she was a little more confused, but we have no idea. I have no idea what that is really doing to her, but people are now convinced this is it's almost like this is the holy water that they have to have. Everyone has to have a gummy every night as their nighttime ritual and it's yeah.

Speaker 1:

Anyway, thank you very much. Any other questions? Great. Thank you, Dr Kamer. We do have a ton of questions, and a lot of them are really good questions, so I'm going to package a few of the ones we've gotten together. There's a general question that's come from a few different folks about. You know, is Schedule 3 really where it should go? What about Schedule 2? Is anyone even thinking about Schedule 2 in this process? So yeah, Kevin, I don't know if you want to lead off the answer.

Speaker 3:

Well, I mean, yeah, dea could turn around and say, actually, now we're going to actually say it should be Schedule 2. So they could change it. You know what does that mean? Again, it means it still has some accepted medical use. So you know, they could. I mean, again, anything is possible. They could do this as a compromise, they could do that. But we, but we really don't know.

Speaker 1:

That's good. Another question was you know what? What would the overall public safety impact be of rescheduling it to three? Sue, I don't know if you want to. If you have an answer you want to add to that one.

Speaker 4:

Well, obviously, the whole safety sensitive job thing is a tremendous problem, but if it was in Schedule 2, you would still be under those rules and regulations. So you know car accidents. We've seen poison control data go off the charts, especially among young kids who are accessing this through their parents having gummies, lollipops, cookies, all kinds of stuff. You know regular drug driving, and the other thing that we haven't talked about yet is just daily use, especially among kids. It's really way up.

Speaker 4:

And as far as the research, I think we all agree we need a lot more research on high potency marijuana and what it does, not only to the adolescent brain but also to a number of other factors. So I think we definitely need that. But yeah, no, car accidents, accidents, er visits all of that goes up as the use of a drug goes up. And I just want to say too, as you saw, kevin showed it people are like alcohol is so much more dangerous than marijuana. It's just so many more people use it. If we get to even playing field and we're starting to almost get there between the use of these two substances, you are going to see many, many more issues with public safety and medical problems related to marijuana, because it has to do with the number of people that use it, and then of those number, some large percentage can get into trouble with it. I don't know if, kevin, if you want to add to that.

Speaker 1:

Yeah, well, what I would say is. You know, I think with more money from the tax write off for all of their business expenses, we can expect a lot more availability and a lot more advertising and a lot more accessibility. Go ahead, dr Kamer.

Speaker 2:

Right. So I was going to say two things that follow up on what Sue said, with the use of marijuana going up to and reaching and exceeding the use of alcohol. We finally got to a stage now where the daily or near daily use of marijuana has equaled the daily or near daily use of alcohol. When I walked to work around the corner in a suburb not even in New York City, but in a suburb I smell weed at 8 am. I don't see people with bottles of alcohol at 8 am.

Speaker 2:

And this is part of this myth of medicine that it's okay, it's healthy. I mean, when people tell me why they use marijuana, what if they're using marijuana 20, 30 years ago? They would say they were at a concert, they were at a party and it's friend. Now it's oh. I use it because I have a pain and I don't want to take opioids, I have anxiety. Maybe no one goes to parties or concerts anymore, but this has become the myth of it's a great excuse. It's a great excuse for people to say it's my medicine. And people look. Patients have told me over the years. Sometimes they say you know alcohol, they have their drinks, that's their medicine, medicine. People said there are other drugs, other illicit drugs? Are there not some?

Speaker 2:

And the other thing that Sue was talking about with the point that as Schedule 3 drug, that THC would come off of the DOT testing panel, is that impairment from THC is very tricky. It's tricky in measuring if someone's impaired, it's not as easy as with alcohol, but for reasons that are the opposite of what I'm playing with a lot of participants, because what is never said is that you can be impaired from marijuana and your blood level of THC will be undetectable. Marijuana and your blood level of THC will be undetectable right In the occasional user of marijuana. The impairment and this has been shown over and over clearly shown that the impairment can last for hours after use and the THC blood level goes under the limit. Within can be the two hours. So the only way to really guarantee safety would be by the urine test. There are other types of testing that shows use for a longer time period. The error on the side of safety. We're talking about airplane pilots, railroad engineers, interstate tractor-tra trailer drivers and school bus drivers.