VERNON BENJAMIN: We're going to be on schedule. So, it's 10:15. Call the meeting back to order. During the break, Ed made a comment to me that maybe we should make a differentiation here between what schedule 1s and schedule 2s are, so I had Lloyd get me the law book and I'm going to read under the category what the federal law is. It says basic structure of federal law consists of five classifications of controlled substance. The degree of control, the condition of record keeping, the particular order forms and prescriptions required, minimum regulatory requirements all hinge on these classifications. Schedule I are: drugs included in this schedule are considered to have: (1) high potential for abuse; (2) no currently accepted medical use in the United States; and (3) a lack of accepted safety for use under medical supervision. And number, Schedule II, are: drugs that are included in this schedule are still drugs that have a high potential for abuse, so there still can be a high potential for abuse to be a schedule 2. The substances has to currently have accepted medical use in the United States or currently accepted medical use with severe restrictions. And number 3, the abuse of the drug may lead to severe psychological or physical dependence. So, in order for it to be a 2, it can have the qualities of the Schedule I. So, there still is... I or II can still have a high potential for abuse. So, the question that we were asking about the abuse potential, even though we say there is abuse potential, that doesn't mean that it can't be in one or the other.
VERNON BENJAMIN: I've been on the Board of Pharmacy now for seven years, going on eight now, and in those years the times when we have been confronted with drugs that the federal government has rescheduled we have followed suit and we have matched the federal government's guidelines through that course of time. Okay.
The next one on our list is whether marijuana's potential for abuse is properly.
VERNON BENJAMIN: Number 8 is whether marijuana is an intermediate precursor of a substance or some other controlled substance. And I'm not sure that that has any...
VERNON BENJAMIN: What that basically is saying is like if there's a parent drug that this drug is made from, to whether or not, if this one's in Schedule II then because this one is ... This is a Schedule II and its a precursor to this drug therefore this drug would be included in that schedule, so its not something that's probably going to have any relevance to what we're doing today. I knew that. That's why I've skipped over it.
LAUGHTER
VERNON BENJAMIN: Trying to move the program along. Okay, number 9 is whether marijuana's potential for abuse is properly reflected in its inclusion in Schedule I.
VERNON BENJAMIN: The comment that I just made was, that even if it has a potential for abuse, there's a lot of other drugs that are in Schedule II that have potential for abuse. So, anybody want to discuss anything about that? I think that, it's just pretty straight forward that it can have a high potential for abuse and be in either class. It's whether or not, the primary thing is whether or not there is a medical use of the medication, that's primary...
Okay, so, that being said, we'll go to number 10, Whether marijuana's lack of potential for abuse is properly reflected in its inclusion in Schedule I. I guess it would be the exact same thing, is that... We all know there's potential for abuse. And, even... Schedule 1s have to have potential for abuse and schedule 2s have to have potential for abuse or they would not be in those two schedules. So, I would say that probably from the literature we've seen and everything that we would say that based on that it could be..., potential for abuse could place it in either category.
Number 11, marijuana does not have a high potential for abuse. Open that one up for discussion.
MARK ANLIKER: It's got a potential for abuse, but deciding between Schedule I and Schedule II, again, it's not that..., it's not pertinent. This list..., on a to do list, this could be shortened to about 5 or 6.
VERNON BENJAMIN: A lot of them basically say the same thing. Again, I'm going to refer back to this book then and go down the list farther. Because what we're deciding today is whether or not we move marijuana from Schedule I, which means we could move it to II, III, IV, V, you know, any one of the medication designations. Schedule III is a substance that has a potential for abuse, but less than those listed in Schedule I and Schedule II. The substance has a currently accepted medical use in the United States. And number 3, abuse of this drug may lead to moderate or low physiological dependence or high physiological dependence. High phys..., I'm sorry, low physical dependence and high physiological dependence. So, I guess that question to me means, what of the five controlled divisions does anybody see this being? And, I guess I'm going to start the discussion out saying that Marinol which is already a prescription medication, which is THC concentrated, is a C3.
SUSAN FREY: Well, I guess I would go back to the documentation that we talked about under number one that says that in order for the DEA to move it from one, out of Schedule I, is that it has to be reproducible. And medical marijuana dosing is not reproducible, if your using the raw product. And so, for me, I don't think abuse is really the issue. The issue is you can't reproduce that dose in a consistent manner.
MARGARET WHITWORTH: Point of clarification in the discussion. Are we dealing with moving marijuana from Schedule I to Schedule II in Iowa? Or, are we deferring to DEA policy? I had understood based on the vast amount of information we were provided that in many situations a state law does not necessarily match with DEA regulations.
MARGARET WHITWORTH: Okay. The tradition of this board is to be parallel to DEA. And that is tradition as opposed to law.
MARK ANLIKER: If we differed from it, it would be in how we interpret this.
MARGARET WHITWORTH: Okay, so, again, walk me through this stuff. Your point on the DEA regulations, does that have to do with the schedule?
MARGARET WHITWORTH: Okay. Did not one of the articles we have, had, address the issue of cloning? So would that in fact not be reproducible?
MARGARET WHITWORTH: If it were available. But was not that study... Did that study not indicate that it could be cloned?
SUSAN FREY: But, I'm saying, for what we've got right now.
MARGARET WHITWORTH: Okay, but that capability exists at least at, in one time in one place with the leap of faith that could be expanded.
ANNABELLE DEIHL: I just asked Mark a question that I didn't understand about scheduling, and maybe you don't either.
MARK ANLIKER: Basically our side discussion, Ann, as a retired nurse practitioner, had asked how does this all tie into writing prescriptions. And I said it won't, it can't. Because...
MARK ANLIKER: Exactly. It's a freedom of speech issue, rather than a... You can't... You can't force a pharmacy to carry it because they'll be in violation of the DEA regs. You can't have a doctor writing a legitimate prescription for it, because it would be in violation of DEA regs. My question is, is there any other situation where we don't match the DEA on scheduling.
TERRY WITKOWSKI: Pseudoephedrine, Ephedrine, and Phenylpropanolamine. In Iowa they are Schedule V. Under DEA regs they are controlled, but not as a controlled substance. It's a totally separate law.
MARK ANLIKER: And we do that because of the whole meth thing, public safety?
TERRY WITKOWSKI: Yes. That... Before the federal government regulated those products, it was decided in Iowa that they wanted to regulate them and the..., they apparently..., well, they decided to place them in Schedule V to get the regulation that they wanted.
SUSAN FREY: You can always be more strict. Where you have the issue is when you try to loosen that, which is where we are.
VERNON BENJAMIN: My understanding it that..., it's different than what Sue's is, so... I don't think that it has to be reproducible to be classified in one of the schedules, but it does have to be reproducible to be a medicine and to get FDA approval. My understanding is that we can put it on Schedule..., if we put it on Schedule II that's not saying that that's a product that's going to be an end product used. That means that it, it's in that classification and the people that are doing the experimentation on it can use that product then to concentrate a form or do..., develop a product that actually would be acceptable to the FDA to run tests on.
VERNON BENJAMIN: So, I think probably what they, just to comment more on what I was saying, opium might be a Schedule II, but we're not going to be dispensing opium to people as a prescription. Products made using the opium poppy to derive products that are Schedule II medications are what is dispensed then, you know, what's derived from that product.
EDWARD MAIER: So, back to 11. Eleven says marijuana does not have a high potential for abuse. I guess if you go right to the bottom line, there is a potential for abuse. We've decided that up above, so, that point, to me, has already been decided.
VERNON BENJAMIN: It does have a potential for abuse. I was saying before, that's why there's controlled substances, is all of them have a potential for abuse. But whether or not the potential for abuse is such that merits it to have no accepted value or no accepted medical use is... I guess we're rating relatively the abuse potential. The abuse potential is there. We have that. Whether it's high enough to keep it in C1 would be what our discussions are centered around, I think. No more discussion on that, then?
Number 12, marijuana has an accepted medical use in the treatment, accepted medical use in treatment in the United States.
MARK ANLIKER: I'll jump in. The DEA classifies it as a Schedule I, and yet the federal government is still providing for four or five medical marijuana patients..., can say there are three in Iowa, with marijuana cigarettes
MARK ANLIKER: Right. Two in Iowa. And are there four or five surviving?
MARK ANLIKER: I guess I could make a case, a fairly easy connection, that there's a problem at the federal level with trying to sort that out, but they are providing marijuana cigarettes for four patients.
MARGARET WHITWORTH: One question I have on this, it says marijuana has an accepted medical use. My question is, accepted by whom? By the federal government? By medical or scientific organizations? I don't know who is the accepter here.
LAUGHTER.
SUSAN FREY: I think typically, from a health care professional's viewpoint, be it pharmacist, be it physician, be it nurse practitioner, accepted medical use would be an indication that has been accepted by the FDA, that that product has gone through the FDA process and has an..., and is listed in the U.S. Pharmacopeia, has an indication it's used for. This diagnosis, here's what you can expect. Here's how it works, and it's gone through that, the clinical studies, and has gone through the entire new drug application process.
MARGARET WHITWORTH: Okay, then, so it is the whole process. So, a new drug that emerges from research would go through all of that.
MARGARET WHITWORTH: Is there, has there been a process that an old, as in historically long lived, product that is not manufactured? Does this get back to your not reproducible thing?
MARGARET WHITWORTH: So any, so that this particular thing would rule out the whole area of, I don't know if it's called alternate medicine, alternative medicine. In other words, processes, or procedures, techniques that do not rely on manufactured substances, then are in and of themselves kind of illegal or fringe because they have not gone through this process.
MARGARET WHITWORTH: And I'm not arguing for this, or a whole bunch for... I'm just trying to understand. Does it only have to go through sort of a corporate process to be, to meet these requirements.
SUSAN FREY: You have two..., you have two processes. A prescription, a medication that is deemed to be..., or a product that is deemed to be used for medicine will go through the FDA process, where they apply for a new drug, as a new drug, then it has to go through animal studies, human studies, clinical trials, and then it goes through FDA, they take all that information to the FDA, the FDA looks at adverse reactions, that kind of thing, and then if they approve it, then it goes into what we call post marketing, so that when a medication is approved for use then it still is continually watched for any adverse reactions that pop up after post marketing. The other process would be the typical non-pharmaceutical ones which would include your vitamins, your health products. And those are not regulated by the FDA. And so those would be, you know, your ginsengs, those kind of things. Those processes, the manufacturing process is not monitored by the FDA. It's...
SUSAN FREY: No. So, it's, there are, there have been some manufacturers of over the counter..., we call those over the counter products, that have banded together to set their own standards, but that is just a certain group.
SUSAN FREY: Yeah. It's a volunteer thing. There's no federal law that requires that type of monitoring or oversight.
MARGARET WHITWORTH: Thank you, Susan, for the tutorial. I feel much better informed. Thank you.
MARK ANLIKER: Only two things I would add to that. In the health food isle, they'll guarantee you that what it says is on the, is in the package is actually what's in the package. It doesn't also talk about what's in the package but it's not on the label.
MARK ANLIKER: Contaminants. If you will, okay? And that's been a bit of a historic problem with some of the natural products. And once a product has been approved with a list of indications, a list of things that medication can be used for, once it's on the market doctors are relatively free to prescribe it for whatever they'd like to.
MARK ANLIKER: And that's the call, what in the heck are you using this for?
SUSAN FREY: The one thing I can say, that I..., that, of the studies that we were given, most every study in the conclusions ended up with the phrase this shows promise, this shows potential. And I think there's a lot we need to, we can learn about the products, and the... There are so many active ingredients in marijuana that I think do have potential, but, you kmnow, I just think there needs to be more research and I think that until, we need, you know, I think we need more information on it. To... And not that it's not beneficial, because I think we've seen that it can be beneficial. But I also think that we've got current products on the market that are as effective and certainly more controlled and more reliable in dosing.
ANNABELLE DEIHL: I would like to add, I agree with that 100%. And there are those who have stepped up to me and said, well, you know, this worked for me or this worked for my brother, or... You're going to find that with any drug on the market. I've been prescribed different medications that are supposed to be totally innocuous but help with, when I had a spinal cord injury. I had one, I took one, I can't even remember now what it was, and I should remember because I won't ever take it again. But, most people who use it had no problem. I couldn't remember what I had... I functioned normally, my husband said, in his office, but I couldn't remember the next day what I had done. So, I tend..., I got off of that. You're going to find that with most any pharmaceutical of any potency, so, you know, I don't think that's necessarily..., I think you're just going to find it with anything.
EDWARD MAIER: I think, to echo maybe a little of what's been done. I think as I read through it, I don't think there's much to argue with as far as there being some potential for use. I think it, you know, there's a lot of good there. I struggle with the reproducible part, you know, I struggle with how do you find a dose that you can put a tag on. How do you do those kinds of things? And, you know, people can take on the FDA, but, you know, if anybody goes back and reads the history book, before we passed the federal, the Food, Drug, and Cosmetic Act, you know, I've still got some things that were sold in pharmacy sitting in a museum back home that were that, you know, wouldn't be sold today because they were sold in those days before the Food, Drug, and Cosmetic Act, and it's there for our protection. And, you know, this is the part I struggle with. This has been a very difficult struggle. This has been a really tough thing. But I still struggle with the fact that, you know, we are talking about a plant. One of these drugs that comes from..., we have lots of drugs that come from plants. You know, but we don't drag up purple fox glove plants today and use them, we use Digoxin. We use a purified form, because that dose is there and we can chemically check it. We know what it is. We know we are giving the same dose every time. This is the tough part about this whole thing. So, yes, I think there is some medical use and potential. It just depends on how you define that word accepted.
VERNON BENJAMIN: The United States government has a patent on cannabinoids and it says in their abstract that cannabinoids do do all those things. And they got it, they were granted a patent for that product to treat inflamation, auto-immune diseases, stroke, trauma, alzheimers, parkinsons, and dimensia.
VERNON BENJAMIN: Right. It's on the cannabinoids from marijuana. But I think, I'll just reiterate again that, by us switching schedules, what we're saying is that... We're not saying that somebody can take marijuana and use marijuana. We're saying that the potential for abuse and the other things that are there, the fact that it doesn't give a medical reproducible thing, that's for the FDA to determine when they determine whether a medication should be used. They, I mean when a drug first goes into a restricted, in the controlled substances act, it doesn't say in there it can only use, you know, 30 milligrams of codeine in a product. It says codeine, and then the company determines what strength they're going to put in it and it does the testing on it. It doesn't... You don't set all the standards and everything up and then do the testing. You do the testing and then get your product evaluated whether is does what you say it's going to do.
ANNABELLE DEIHL: I have on problem with that. I mean, have there ever been any other drugs patented that were not approved by the FDA? A patent and FDA approval are not the same.
MARK ANLIKER: There'd be a number of them, because they, the drug companies, big pharma, if you will, has to patent the entity before FDA approval or somebody will steal it from them.
SUSAN FREY: I want to go back to your point about, you know, listing the drug and then the company determines the dose. The part of that, that process that the company goes through, is determine, or, they have to show the FDA that that dose reproduces the same effect on a consistent basis. And that's part of the...
ANNABELLE DEIHL: I think we're still kind of in a quandary. I mean, the same person who, the same entity that puts it on Schedule I sends it out to people for use.
VERNON BENJAMIN: Patents a product that is the thing, puts in C controlled class 3 the main active ingredient in the product and then says it's Schedule I.
VERNON BENJAMIN: The main active ingredient is how I see it evolving. One of them.
Number 13 is marijuana does not lack accepted safety for use in treatment under medical supervision.
LAUGHTER.
MARK ANLIKER: And it's hard to suppose that because nobody is, relatively nobody is supervising the usage of an illegal product the way we think about supervision.
SUSAN FREY: Well, and, as I was looking at the..., as I was reading our studies and looking at that, thinking about that, I guess one of the things that became apparent was that there have not been any longevity studies on whether or, you know, what the potential harm would be of the use, when you're looking strictly at health safety of the person using the medication. You know, there was one study where the people, they, the range was, or the average time was two weeks. The range was from 4 days to, I think what, 4 years or something like that. And, so, you know. And, so, the longest study that I saw where they had looked at the ill effect of marijuana use was 12 months. And that's just simply not long enough. I mean, we know it takes a long time. Plus the other factor was that a lot of those studies had people that were also cigarette smokers. And so it was difficult to separate strictly marijuana use and the development of any lung issues versus those people that had been cigarette smokers. And, you know, that's, again, you're not comparing apples and apples there.
SUSAN FREY: So, for that reason, I feel that there is a safety issue. That we don't know what that longevity, you know, what the long term use of marijuana will do.
MARGARET WHITWORTH: I think also its interesting here, in terms of accepted safety for use in treatment under medical supervision, because I think that what would enter back has to do with the medical supervision and a modification if there are negative impacts. And the other thing, and this gets to the anecdotal, not to the scientific with which we are dealing, safety for use of medical marijuana for people who in fact have terminal illnesses. It becomes a different issue.
MARGARET WHITWORTH: Your longevity of any of the studies, I think, is a big issue and once again gets back to the amount of scientific knowledge. We simply need a whole lot more. Because I don't think 4 days is anybody's definition of very long.
SUSAN FREY: And the other point I would bring up, in my mind, is that medical marijuana, in my opinion, medical marijuana is not the first drug of choice to treat any medication, or, any illness. We have FDA approved medications out there that should be the first choices and tried first. I think that when we talk about compassion care, you're talking about those people that have tried everything else and that nothing else has worked. I felt, Ed mentioned the gentleman from Israel, and I cannot pronounce his name. I apologize to him. But, in, I thought he made it a very interesting fact is that even though they do have medical use, medical use in Israel is very strictly controlled. In order for a patient to have the medication, they have to go through a peer review. I mean, the physician has to, you know, show to his peers, I think they had, what, three physicians or something that were in this peer review committee, that they had to have three physicians that reviewed the case to make sure before that person went on to use medical marijuana. And, so, to me, that speaks a lot to the fact that they, you know, even in those countries that use it, or that allow it, that it is not the drug of choice to be the first line.
MARGARET WHITWORTH: And I think from our perspective your points are extremely important, that, you know what we are talking about here, a vote on a schedule change. But the real concern I think we all have is not that issue as much as the implications of the change and then how, you know, really, the delivery system, the controls.
SUSAN FREY: ...in the use of the medication, of any medication.
VERNON BENJAMIN: Well, just right now, see if there's any more input and then, I guess, we go around the table and each person give their evaluation of the discussion and how they feel and what the basis of their argument would be. That sound logical?
SUSAN FREY: Well. like I said, I think I have learned a lot through this whole process. We've had a lot of material, and I echo Vern's comments at the first, is that I appreciate all the input that we've had. Our goal was to do a very thoughtful and thorough review of the information and, you know, present, so that we could make a very deliberate decision. And, certainly that has been something that I have taken very seriously. I feel that based on my review and, I think that marijuana should stay, we should keep it in Class 1. But I also think that we should consider reviewing our rules for the experimental use and revive the classification in Class 2. As a health care professional I have really struggled with the need of those patients that truly need the medication, and, if they do, it's very difficult for me to say no you can't have it. But, I think that without adequate controls we would have mayhem. And that is not what this board is about. This board is about keeping the public safe, keeping the individuals safe, and in giving them a decent product, and having them have a substantial safe product that they can use. And, so, my recommendation would be that we look, go back and look at our previous rules for the experimental use and perhaps reactive those for the use, for compassionate use.
EDWARD MAIER: Lloyd, remind me. Previously it was changed to Class 2 for the use of, for the purpose of investigation. Right?
LLOYD JESSEN: Right. We have a dual classification right now. Its classified both as Schedule I and Schedule II, but it's only Schedule II if this board has administrative rules for the medicinal use of marijuana. And we can go retrieve those rules from the late 1970s and read it to you. It was basically for investigational use. It's our understanding, we weren't with the board at that time, but it's our understanding that those rules were never really implemented.
TERRY WITKOWSKI: The rules were adopted, but there were no research programs. That's what I was told at the time they were recinded, anyway, is that nobody applied for any research programs under those rules.
LLOYD JESSEN: But we can refresh the board's memory of that historical piece and you can see what you want to do with it.
SUSAN FREY: And, I, somewhere, I, we had those rules brought out. I can't remember when. But, in those rules it allowed for peer review. It required, you know, a good study base. They were very, it was very controlled. And, I think that is something we need to consider as a board.
EDWARD MAIER: I, I, too. I really appreciate the fact that so many people showed up at those, at those hearings. They had, we had a lot of good input. We heard a lot of things. And as a health professional, and I think, you know, I'm a small town guy, just a guy from out back in the hills of western Iowa. You know, pharmacists, we get to know our people and we really are compassionate people. We want to do what's right for people. And I could hear in a lot of those, in a lot of those appeals out there that, your know, this is something a lot of folks would want, want to do, and they just don't want to be breaking the law to do it. Having said that, however, I look at this thing, and I think that there are just so many things. I look at a potential distribution problem. How do you put this out. I don't believe any of the states that have done it so far have done it right, completely. I believe none of them have done it exactly right. And, so, I guess, you know, at this point in time I would, I might lean exactly toward exactly what, what Sue has said. In other words what we would do is we would retain exactly, we would make no action. We would leave it as Schedule I, except it would be Schedule II under an investigative situation. And then we would look at those rules and make sure they had some teeth. The problem that we have, one caveat to that is, you know, in present economic situation who's going to be able to fund the studies. How are they going to get done. You know, that's just something I throw out there as the... I certainly think something needs to be done. You know, there needs to be a group of people enabled to take a look at this from different disciplines, you know, and take a look at this and decide exactly what needs to be done in this thing. And I'd certainly be in favor of having, you know, a group of physicians, pharmacists, treatment people, law enforcement, what have you, take a look at this thing and really investigate it. Because I think there's no doubt, there's no doubt that there is some, there is some benefit. Could we benefit more if somebody did some research and tries to come down with the specific, instead of looking at hundreds of different components in marijuana. If we could come up with specific components, I think that that would be the ultimate solution to this thing. We don't have it right now. So, I guess that, yeah, I would lean towards actually just not doing anything with what we have right now, but to take a real hard look at the Schedule II that's in place and see what we can do with it. At first blush it looks like these rules would have to be dusted off and completely updated.
EDWARD MAIER: But the law, I mean, the code is still there. Right?
MARGARET WHITWORTH: What are we waiting for? I'm a little confused here. Are we making our closing arguments, or what?
MARGARET WHITWORTH: Alright. Having reviewed the 13 points, and goodness knows an incredible amount of information. This is, obviously, very complex. There are, you know, I think I had understood the schedule change what our responsibility is. My concern has to do... I got all kinds of concerns. One of my concerns has to do with the fact that I have heard with my, the last two of colleagues, one is to redo the rules, the other is there is no doubt there is some benefit. I am concerned that we are, to be really trite, letting perfection be the enemy of the good. I do not know that we can solve all related problems, deal with all related issues. But I'm not convinced that simply redoing the rules and not moving of it up, trying to move forward to see if there in fact ways in which medical marijuana can be made available under highly controlled circumstances to people who can find relief from pain. I will admit very definitely that I have a personal experience of watching my mother die from bone cancer. The woman was addicted to morphine, had some kind of bizarre surgery where nerves were cut so she would not feel the pain and went cold turkey off morphine because she didn't think she should be using it. Anything that could have given that woman relief I would have wanted to have at least the opportunity to pursue it. I realize certainly that consideration of medical, any legalization of medical marijuana will loose the people who want all rules removed. I cannot be responsible for that. I realize that the interest in this issue is significant, the number of people who submitted anecdotal or scientific information, the number of people who spoke at the various hearings, the poll that was in the Register yesterday. As Mark said, this isn't running for prom queen. What's most popular is not necessarily what we need to do, but I am not convinced..., talk about double negatives..., I am not convinced that not acting is the right thing.
MARK ANLIKER: As we notice from the three previous colleagues, reasonable people can come to different conclusions looking at the same information. And I truly believe this is that divorce issue, his story, her story, and the, the middle out there. The baggage I bring to this is a pharmacist, and we're used to dealing with a product, that's in a dosage form that you can identify, that's got a strength that you're familiar with, that you know what it is by the labeling, you know what's in it, you know what the purity is, you know where it came from. Marijuana cigarette doesn't meet any of those. Just random thoughts as I listen to the discussion and I kind of use that as my summary. We have not heard anything from law enforcement, and that's a huge issue in my way of thinking. I don't believe there was anything submitted in the, that 30 pound box that any information about law enforcement's stand. I assume I know what it is, but I don't know for a fact. We heard from area substance abuse agencies. They're concerned. I understand that concern. That's, that's their livelihood. That's what they do. They try to protect who they view as their constituency. As we look at this, there's no way we're going to be able to provide a legitimate safe source of supply if we decide to make a move on this product. We can't, we can't say this is where you get your Iowa seal of approval medical marijuana. Like many medications, a percentage of patients using this product are going to have psychosis, schizophrenia, tachycardia, MI, stroke, those things are going to happen. Side effects happen with other medications. If this was an FDA approved medication it would be one of those wonderful med-guide things. I'd be handing out a 13-page, this is what may happen. Read the next one because they may change it. They may change the information in this med-guide, but the information hasn't changed. I guess I am in favor of recommending that the legislature review changing scheduling from Schedule I to Schedule II. For me to not do that would have required that there was no information about any kind of legitimate medical use out there and I think there is at least some legitimate medical use going on. Legitimate, as we've talked about, is open to interpretation. But I think there is enough use out there that I could make up the prom queen thing and punt it to the legislature and say I think we should, I think it's prudent for you to review this, changing it from Schedule I to Schedule II. Understanding dusting off the old regulations, I think that's fraught with problems as is the source of supply, because in the information we've got it seems that its very difficult to have legitimate research done because its hard to get product, well, it's hard to get approval, its hard to get product, hard to get reasonable product. It appears the U. of Mississippi is growing product from the 70s, and we need to have current product to really do current medical research. If I was disappointed in anything in that 30 pound box, it was the volume of information before, pick a date, 1985. More current stuff than that would have weighed more heavily in my thinking. Now, whatever we do here today, I think the understanding is that we can't provide a source of supply and we can't protect you from the federal government. You know, this is, whatever we do today, but the federal regs are going to continue. End of story.
ANNABELLE DEIHL: Well, as a nurse and a care giver for over 30 years, there's parts of me that's still wrestling. I watched my mother die. Thank goodness I didn't have to deal with the pain issue. But I've taken care of, I couldn't even tell you how many people I've taken care of that I've wished I could have helped through the pain part. And if this issue were only about compassionate care, I would..., if changing it to Schedule II would provide compassionate care I would be 100% for that. I'll have to agree with what these two said, I, the caregiver part of me also wants safe delivery of medication, safe deliver of medication and delivery of safe medication. I don't know that this is and... And my third point is if we change it, if we recommend changing, we can't change it... But, if we recommend to the legislature changing to a Schedule II, what is the point? If I were still prescribing, I couldn't prescribe it for those people that I thought really needed it. I could just say, well, you know, have you thought about this. I'm not sure I would do that, when... I don't know what I would do. I'm against it. With those things still swirling around in me, I just cannot see the point in changing to Schedule II at this time, recommending changing to Schedule II.
EDWARD MAIER: Could I ask a question? We've got the rules that were made. Do we have the original citation from the code that..., the law that created that?
TERRY WITKOWSKI: These were created based on a piece of legislation, or a bill, I mean a law that authorized the board to adopt rules for research program. That code section then was..., it grandfathered out.
TERRY WITKOWSKI: The research part of it, yes. This was specifically and only for research. It was not for medical use. After that grandfathered out, then the legislation was, the code was changed to provide for medical use pursuant to board rules. And that's what the code currently says.
LLOYD JESSEN: Here's what it says right now, 124.206(7)(a), marijuana when used for medicinal purposes pursuant to rules of the board. And that's under the Schedule II classification.
TERRY WITKOWSKI: So, marijuana currently, what that amounts to is its Schedule I unless the board adopts rules for medical use and then...
EDWARD MAIER: So, can I suggest, that my colleagues who want to change it to Schedule II, it's there. It's there. What we need to do is promulgate rules that would say exactly how that needs to progress, as far as research or whatever.
LLOYD JESSEN: If you go that route, then the issue for you is in your rules to determine all those things you talked about this morning that all the other 14 states have struggled with, how to do it, and that's the issue you'll face.
MARGARET WHITWORTH: Is that the appropriate role of the board of pharmacy as opposed to the rules of the legislature?
LLOYD JESSEN: That's more discussion you need to have. Who's the appropriate body to do that, you or the legislature?
TERRY WITKOWSKI: The legislature at the time that this code change was made determined that it was the board of pharmacy that should adopt those rules.
TERRY WITKOWSKI: The board of pharmacy has never acted upon that authority. So, if you...
SCOTT GALENBECK: Well, and the other things I would say is that any rules that you adopt go through this rule process that you're so familiar with, with public notice, public comment, and final review by the legislative rules review committee, is a branch of the legislature. So, there are many steps in the rule making process.
MARGARET WHITWORTH: Okay, my basic question comes down to, if that is in fact the, an option, the preferred option, what have we been doing? No, I'm very serious. Have we been creating a lot of work, spending a lot of time, raising hopes or fears of a lot of people for naught?
LLOYD JESSEN: No, because you have dual classification right now. Without rules, it's Schedule I here. So, we have no rules, it's Schedule I.
MARGARET WHITWORTH: Okay, so, if we would..., if we would vote to change it to Schedule II, what are the next steps? It has been my understanding that then it became a legislative matter.
LLOYD JESSEN: That's correct. If you recommend that it be reclassified as Schedule II, that's the first step of the process then for the legislature to consider it. Either a legislator could take it up now and run with it, or we can pre-file legislation for the next session which presents it to them, they have to act on it.
MARGARET WHITWORTH: Okay, then, excuse me just a minute, then if we are dealing with the issue that's just been raised with it being in two schedules, then what's the process.
TERRY WITKOWSKI: If you decide that you want to leave it the way it is now and proceed with rules, then it would be up to the board to draft rules, adopt rules that would provide for a means of opening up a medical use program for marijuana.
TERRY WITKOWSKI: Right now you have, the board has the authority to adopt rules under which medical marijuana, marijuana can be used for medical use. If that is the decision, if you decide that you want to move forward with that, then this board would have to develop those rules, propose them, put them through, as Scott mentioned, all of the public notice, etc. But you would have to, in the course of that, probably address all of the issues that have been raised here about how are you going to make this product available, where is it going to come from, etc. But you have that authority under legislation right now to do that. Where you can decide how your medical marijuana program, or how any medical marijuana program could be legal in Iowa, and you can address that by rules.
LLOYD JESSEN: It boils down to who do you think should do it, you or the legislature. In keeping in mind, the legislature has to basically review and approve what you would do on your own. But, still, the focus in on who has the primary duty responsibility.
TERRY WITKOWSKI: And if you decide that you don't want to do it under the current legislation, but you want to make a recommendation to the legislature to change the schedule, scheduling for marijuana, what you would recommend to them actually would be to remove the current provision that puts marijuana in Schedule I, remove the current provision that says that it can be, that the board can adopt rules for medical marijuana, and simply move marijuana into Schedule II under the hallucinogens. And then however that's going to be made available to the public is going to be up to somebody to make that determination. Because that still would be something that's approved for medical use, which means that it has to be under medical supervision. So, somebody's still going to have to determine how that is going to be done. If you take your authority out of the code, then that take it back totally to the legislature and it's up to them, or someone, to propose legislation that would provide for medical use of marijuana.
MARK ANLIKER: Back to my thought, I guess, if I was thinking we were going to..., my scenario was punting to the legislature and hard to think for that many people, but I could anticipate them saying you created this, take care of it, so it would be back in our lap anyway.
MARGARET WHITWORTH: One of my concerns is what you just raised, the relative fact that we haven't heard from law enforcement. There are probably several other things we haven't heard, you know, groups from which we haven't heard. What is our obligation to get them to talk? You know, this is a..., because my inclination has to, would be to, that it should go to the legislators, because they represent very specifically, you know, their own districts, you know, this kind of a thing. I think that the board of pharmacy has done an admirable job of seeking input, but I think its very different, in terms of, because we are all, quite frankly, appointed. And I would admit, and apologize, not understanding at all this whole other option.
VERNON BENJAMIN: This option would only be able to happen if the legislature votes to approve an extension. Because there's three options...
LLOYD JESSEN: Scott can explain that, what role they have in our promulgation of rules.
TERRY WITKOWSKI: Well, first of all, I want to point out, this is not medical marijuana rules. This was a research project, or program. So, this is not in, the same as what the code currently authorizes.
SUSAN FREY: And I would, I would suggest that, and I apologize for bringing this forth, because I thought this was medical, medical use. It is not. It was strictly research.
SUSAN FREY: I was confused on that. I did not have that clear in my mind. So, this document really has no relevance.
SUSAN FREY: And it's just historical, and I would like to take that out of the discussion, period.
EDWARD MAIER: If we were to go do that, we would have to promulgate all of the rules for the whole program. Personally, I believe, even if we do a schedule, if we change this to Schedule II for the purpose of moving this, this discussion to the next level, I really don't believe, personally I don't believe that this decision belongs in the hands of all pharmacists, and I don't believe it belongs in the hands of all politicians either, although I do agree with your point that those are the elected people and the people speak. I've looked through, Vermont put together a study committee and it was a very good cross section of, there were, and one of the other states did eight different disciplines, palliative care, the attorney general's office, people from the judiciary, chiefs of police, physicians, etc. I think that's the kind of body that needs to look at the other states and put this together. It shouldn't be all pharmacists. It shouldn't be all politicians. Politicians, quite frankly, are not, you know. experts in this kind of thing.
MARGARET WHITWORTH: You mean elected officials, or are you focusing exclusively on the politicians?
LAUGHTER
EDWARD MAIER: I mean you see where I'm coming, what I'm at. I think that the, if, I would almost go along with Class 2, if there was a strong enough recommendation there, that a cross section of people from different disciplines are involved in putting this delivery and everything else together, so that it's truly...
MARK ANLIKER: That Vermont paper was a nice piece. It had all of the stake holders involved, from the president of the chiefs of police association, to the attorney general's office, palliative care, chemotherapists, had everybody. I buy into that.
EDWARD MAIER: I'm worried about just classifying it Class 2 and wondering what's going to happen with it from there. A strong recommendation about what happens with it is another thing, about where it goes.
MARGARET WHITWORTH: And, I, the reason I would like the committee, is this board, for example, we are aware of many issues in other states that are a problem. We cannot anticipate all of them. The devil would be in the details, that the
Vermont approach, in terms of taking it to the next step, I think, is a reasonable and as thorough as it can be.
SUSAN FREY: And we also have to realize that there are products in the FDA process now that are cannabis based, that are in inhaled form, that will soon, hopefully, be available, if they pass through the FDA process, which might make this whole thing a moot point. But, you know, we need some... We've got to make a decision today, so...
ANNABELLE DEIHL: You know, that changed my thinking a little bit. I think I'm, I think part of the thing that caused me concern about just recommending change to Schedule II was, you know, what's going to happen. Who's going to run with this and where is the public safety? But, you're Vermont example is excellent.
EDWARD MAIER: We have to remember, though, these are just recommendations.
EDWARD MAIER: The legislature might take it, and forget part of it. But, you know, that's not our problem. Our problem is to make the best... Vern, we haven't heard from you yet.
VERNON BENJAMIN: I, I just had some points that I was making as everybody was talking about different things, but... I think the purpose of moving, my opinion, the purpose of moving it to a C2 is so they can do more testing of the marijuana, and, hopefully, like the medical groups are saying, to develop alternate delivery systems to other than just smoked marijuana. I think the fact that the U.S. government has a patent on the cannabinoids makes a big point in that the federal government does approve of the use of it, it's just they've got caught where they're, they've been enforcing the rules against marijuana all the time and they are going to have to come up with something that's going to... There'd be no reason for them getting a patent on that product if there wasn't somewhere down the road where they were planning on using that patent for some... Marinol, which is concentrated THC is already a controlled 3 substance. We discussed earlier that there's political and ideological profiling done to have marijuana come to the point where it has in our society. The FDA does not approve of bulk substances or active ingredients. They approve the direct prescriptive product, the product that's been tested and tried. So, to say that the active ingredients is something, is based from marijuana isn't meaning the product you're going to have eventually maybe be written by the doctor be marijuana. It will probably be the active ingredients that do come from the marijuana plant originally. Just reading what the stipulations of this medical use for marijuana that we could have done back then almost sounds like, like Ed was talking about the guy from Israel saying, is... I'd be convinced that medical marijuana is something that should be able to be available. If it takes three physicians to approve that process, that's exactly what the research project showed was that three physicians would have to approve the person to be in the research project for the medical marijuana. I think, personally, I think the time's come for us to do some kind of action, which I think was probably expected to happen back then but didn't. So, whether it would be to reinstitute a program like this to basically get medical marijuana in the, at least planning stages, I'd have to say that this would be... If you're, if we're just going to directly reschedule marijuana into Schedule II and make a recommendation for how to set the program up, I'd say that, I agree with the, we need to make a suggestion as to what state's guidelines to follow, but I think that's probably something that if we're going to go that route we can actually maybe today agree on what kind of action we're going to take and then maybe have another meeting which would be what we recommend as far as what action plan to follow.
MARK ANLIKER: I understand the thinking there Vern. I'd like to wrap it today.
EDWARD MAIER: I'm going to suggest that we take a five, ten minute recess.
EDWARD MAIER: Let's do lunch. That would give us time to maybe craft some kind of a motion and be prepared when we come back from lunch to wrap this thing.