VERNON BENJAMIN:  Well, its 9:02.  We'll call this meeting of the Board of Pharmacy to order.  As we do roll call, what we'll do is we'll go around the table and you say your name and what your position is on this board.
SUSAN FREY:  I'm Susan Frey, Vice Chairman of the Board of Pharmacy, pharmacist from Villisca, Iowa.
EDWARD MAIER:  Ed Maier, pharmacist member of the Board from Mapleton, Iowa.
MARGARET WHITWORTH:  Peggy Whitworth, a public member of the Board from Cedar Rapids.
DEBBIE JORGENSON:  Debbie Jorgenson, Board staff.
BECKY HALL:  I'm Becky Hall, Board staff.
JIM WOLFE:  Jim Wolfe, Compliance Officer.
BERNARD BERNTSEN:  Bernie Berntsen, Compliance Officer.
SCOTT GALENBECK:  Scott Galenbeck, Assistant Attorney General.
TERRY WITKOWSKI:  Terry Witkowski, Board staff.
LLOYD JESSEN:  Lloyd Jessen, Board Staff.
MARK ANLIKER:  Mark Anliker, pharmacist member from Emmetsburg.
ANNABELLE DEIHL:  Ann Deihl, public member from Osceola.
VERNON BENJAMIN:  I'm Vern Benjamin.  I'm chairman of the Board from Argyle, Iowa.
VERNON BENJAMIN:  First, I want to thank Lloyd and all the office staff for all the work that's been done on this project this far.  It's been a long process up 'till now.  I also want to thank anybody that spoke at the forums that we had in four different locations and all the input that we've got.  I'd like to thank those that submitted data and information.  We got a lot of information from people other than at those meetings to help us in our decision making.  So, it took a lot of effort to get to this point.  And, if you saw our boxes, or box, of material, you can see how much material was collected.  Besides, there are several CDs in the box that have a lot of other information other than just printed material.  We need to announce, too, that this is a public meeting.  The input from the public into our decision making has ended.  Today, its a discussion among the Board members.  And, comments from the public are not going to be admitted into our decision making.  And, if anyone has to be reminded more than once of that, then Luke, our Highway Patrol man in the back of the room, will escort you out of the room.  So, just to try to try keep it peaceful so it goes forward in a manner that we all want to have it do.
What we have is a list of 13 points that we as a Board...  Oh, cell phones.  That would probably be a good idea.  Everybody make sure that their cell phone is on vibrate so that we don't get that interruption.  We have 13 points that the law requires us to make a decision on when we schedule a controlled substance.  And, what we're going to do is we're going to discuss each one of them as we go down the list, have input from the Board members, get their opinion, and then at the end of the discussion of those things then we would get to a point where we should be able to get a vote on the issue of whether we're going to reschedule marijuana out of Schedule I.
So, the first one that's on the list is marijuana, is marijuana actual, ...  What is marijuana's actual or relative potential for abuse?  So...  Open the discussion up.  Jump in.  This discussion is going to go real fast.
UNIDENTIFIED MALE:  We don't want to be here all day.
SUSAN FREY:  Well, I guess I'll start it out.  I do think that the literature has shown us that there is potential for abuse.  We've had numerous reports, follow up reports, from the states that currently have medical marijuana that, you know, there have been abuses to the, not only with the medication, but to the system.  And, I think that is encompasing, is an encompassing factor that we need to consider as we're, during this deliberation.
MARK ANLIKER:  The struggle in my mind is whether its got a greater potential for abuse than other medications that we've got in Class 2 at this point.  And, I've been tossing that around since I start reading through that 3 pound box of information.  I'm waiting to see how the discussion goes on this issue.
SUSAN FREY:  You know, the fact that it is, it does alter the mind's perception to pain by affecting the pain receptors that it does.  It does alter the mind's perception of pain, so, therefore, it does have, in my opinion, a potential for abuse.
VERNON BENJAMIN:  We've got a lot of literature that spoke to that point, and it's probably one of the things that all of us have had to mull over in our minds is that there are things that are on the market right now that have a potential for abuse and alcohol, being something that's legitimate, still has a lot of abuse of it, does has a lot of negative effects, but the idea is it's something that's allowed to be used by the general public.  Most of the opiates that are on the market have probably a higher potential for abuse than what the marijuana does because of the, I would say the addiction potential for that.  Part of the abuse of some things is as long as its illegal its probably going to be abused because it offers that incentive for people that can't use it to use it just by the fact that it is illegal.  We lowered the drinking age to 18 and 19.  18 and 19 year old kids probably didn't seek it as much because then it wasn't like skirting the law.  I think, definitely, with all that we've seen in the literature, the pile that we had on the adverse effects of marijuana, was probably number 2 behind other medications.  Alcohol being the first one that has the most potential abuse and the probably the narcotics drugs and then marijuana after that.  It probably does have potential but probably not as much as some of the other drugs that are available by prescription today.
EDWARD MAIER:  Yeah, I think as I read through, I see that there is definitely potential for abuse.  The question I have, much like Mark:  What's the relative potential there?  However, I do look at the track record in states like California, where it's evident that there's been some abuse even of the system that's been put in place there.  And, most of that is because of the abuse of the system which is not going to happen.  So, I think its very important to have some controls.
MARGARET WHITWORTH:  I think its two different things that they're talking about abuse of medical marijuana, or marijuana, and the abuse of a system that may have been put in place, because they are two actually different factors.  And I think our discussion, you know, certainly is acknowledging here that particular issue.  But I think we need look in terms of the questions here.  And the system of delivery, should a change be made, is an entirely different issue here.
VERNON BENJAMIN:  Do you have anything you want to add, Ann?
ANNABELLE DEIHL:  No, I'm sort of like Mark.  I've seen alcohol abused.  And I've seen marijuana abused.  And I've seen prescription drugs abused.  Reading through the literature its hard for me to discern which is the most, and which has the most, potential for abuse.  I'm speaking as a person who was...  I'm the age where it was not available to me when I was a young person, so we got into my dad's alcohol.  Then by the time marijuana...  I didn't even know what it was then.  By the time it became available, I had two young children and I wasn't interested in doing it right then.  So, I'm still wrestling with...  I'm not wrestling with the fact that it can, has a potential for abuse.  Because I think anything that makes you feel good and you can get..., does have a potential..., whether or not its...  Whether or not it exceeds drugs on Schedule II, I'm not sure.  And I'm open to hear more from the rest of the Board.
VERNON BENJAMIN:  Okay.  Is there anything else on that?  We'll go to number 2, marijuana's pharmacological effect.  So, basically, what its asking there is the pharmalogical profile, the negative effects of a medication, such that it would be classified as a Schedule I, which means there is no pharmalogical reasoning for using the medication or is there stuff to show that there is pharmalogical effect that's positive.  Go to Sue again.
SUSAN FREY:  All right.
VERNON BENJAMIN:  Right around the table.
SUSAN FREY:  Okay.  In this, I feel the information stated very clearly the concerns of the adverse effects, particularly those of paranoia and the effect that it has on younger brains.  I was very interested, I found that very fascinating, and found the information very helpful on that, in that it, in the studies that we looked at, they, there are effects, ill effects on all products, the smoked marijuana, oral marijuana, oral THC, they all have adverse reactions.  They all have similar effects.  A lot of them are dose dependent.  But, there again, we come with, when we're looking at the raw product, we have no way of standardizing that dose.  And, that, to me, is a problem.  That would be enough for me to say that it still needs to have, that it needs to remain in Schedule I.  As you're look at the criteria for, at the federal level, to change a medication from Schedule I to Schedule II, one of the first things is that it has to be reproducible.  That the product has to deliver the same thing each time.  And, with the raw product of cannabis, that reproducibility is not there.  And, so, as a health professional, I would have a difficult time recommending that therapy because I couldn't guarantee that the patient would get the same effect each time.
EDWARD MAIER:  I think Sue probably brought up my concerns in this situation, is the reproducibility of the pharmacological effects.  There definitely are, under certain cases there are some positive effects, but there also, along with that we're looking at some negative side effects that are a concern.  And, the biggest thing is the reproducibility.  It's just inherent with that plant, that botanical, that there's not, you know, each plant is going to be different.  And trying to...  And in there are several, as...  The states have struggled with that, the ones that have made it legal, how big a dose?  How much do you allow?  Because the dose is not reproducible.  There are several states that struggle to say how much do we allow because its hard to reproduce that effect.  That's a concern.
MARGARET WHITWORTH:  I certainly agree with that in terms of what is a dose and how is that, how would that occur.  And I think that is simply one of the realities of dealing with the issue.  And that is one of the unknowns.
MARK ANLIKER:  In that stack of literature that we looked at, I looked at far more rat and mouse studies than I have in a number of years.  And the whole cannabinoid receptor issue, you know, that's pretty much a given in my mind.  Again, effects in humans.  So, I guess, I really narrowly looked at number 2 as a straight yes or no kind of answer.  Those other issues we do need to discuss, obviously they're part of the larger picture.  There's a definite pharmacological effect, in my mind, in humans with smoke.
ANNABELLE DEIHL:  I would go along with that.  I really don't have anything to add.
VERNON BENJAMIN:  I think probably, when I looked at this particular point, my thought was that in a lot of the literature where the doctors are making comments about the negative effects of the medication, and that one of the main things that they're talking about is the fact that it is, right now, in the smoked product you're having the marijuana smoked at a temperature where its burning, the product creating tars in the system...  They said that the tar was like 4 times as much that you got from a marijuana cigarette as from a regular cigarette, and when you take that into the fact that when they are smoking marijuana the whole intent to get more absorption is to keep it in the lungs longer so, therefore, you're having the product in the lungs longer allowing it to have more of an effect, negative effect, from that.  Most of the literature where the doctors are actually making a recommendation, they're recommending to find an alternate delivery system.  Most of them that are doing anything right now are saying that the preferred method is to use a vaporizer, where you don't get the burning of the product, you get the oils, resins coming up into a vapor form and breathe.  There was some discussion where that type of delivery system versus the smoking was not effective, as effective, because you could take a couple hits off the joint and if you feel good then you could just quit.  Well, the exact same thing is true about the vapors.  If you get the relief that you want, you just stop.  The product that is taken orally, which is by prescription, is a medication where you take it and you ingest it and you get a set dose.  There is no titrating, I guess you'd say, of the effect of the medication.  It's a set dose.  The products that are on the market that have the THC in them, one of them is an oral mucosa where you put it, apply it right into the mouth.  It's absorbed readily.  You don't have any of the burning.  And, without them knowing exactly what all the ingredients are of the smoke that is being inhaled from a cigarette its pretty hard to tell what is causing the pharmacological effect with the THC and the, I can't think of the chemical name, the other ingredient they put together in the product.
UNIDENTIFIED FEMALE:  CBD.
UNIDENTIFIED MALE:  CBD.  Cannabi...
VERNON BENJAMIN:  Cannabidiol?
UNIDENTIFIED FEMALE:  Yes.
UNIDENTIFIED MALE:  Yes.
VERNON BENJAMIN:  If you have those two in combination you get better results.  There again too, what they're trying to do is do the research to make sure that they have the active ingredients determined what it is and a delivery system that will work that will be able to be recommended by the doctors.  That they won't have the qualms about writing something that might do damage as well as help the individual.  Anybody else?
Third one on the list is current scientific knowledge regarding marijuana.  Some of these things are going to start getting to be redundant, because when we thought about them ...
SUSAN FREY:  To be real honest, I was amazed at the amount of information that came about.  That being said, there are couple of things that I did find problematic in the information that we received.  First of all, the studies that were done were very small studies.  And, you had a lot of people that were excluded from studies.  We didn't know what the sample size was.  Sometimes we didn't know statistics.  We didn't always have complete information.  And so, I found that a little problematic.  I also found problematic the fact that we were given a lot of information of oral versus smoked, in that, you know, you're kind of, you're talking about different delivery systems and so they work differently.  Your effect might be a little different.  So that, I sort of had to sort that, through that a little bit.  The one thing that I was impresses with, though, is that I think the oral THC products have been getting a lot of bad rap.  And, in the studies, I have been impressed that actually given the appropriate dosing, and with appropriate monitoring, that they can be just as effective or more effective.  It's taught me that in my practice we're probably not dosing it appropriately.  And, so I learned something new from this information.  So, I think that we need to do more work on using that medication better.  I think we need to do more education with physicians to use the oral THC in a more appropriate way.  And, I think that the other problem that I had, particularly when I was looking at the studies with glaucoma, is that those studies singled out particular active ingredients of the marijuana plant, different ingredients, and made it more difficult to say that, yes, as a whole, it was effective, because the studies that we looked at were, you know, effect might go from 4 minutes to several hours, and, so, that was, you're not comparing apples to apples in those cases.  But I was overall impressed with the amount of scientific knowledge that was prepared and presented to us, but I did have some reservations in the quality of that information.
EDWARD MAIER:  I guess I would echo what Sue says.  I think that there was, there was certainly a lot of information there.  Some of it was very good.  As I read it, if you've, if you've ever had some training in how to look at scientific literature, a lot of those studies were small, a lot of them.  That makes it very difficult.  The power of the study, then, is not as good as it would be had we had a larger sampling of people.  The other thing that I noticed is that a good many of those were a comparison of marijuana to placebo, to something that has no effect.  There was an overall lack of comparison of marijuana to present treatment modalities.  Things like, you know, a comparison like in glaucoma of marijuana to Timoptic or one of the eye drops that's used presently.  How effect is it in comparison?  Is it better?  Is it worse?  Those kinds of things were not very well addressed in the literature we had.  So that was a concern.  I think there was a lot of stuff there and I think it needs to be looked at seriously and longer.
MARGARET WHITWORTH:  I would agree in terms of looking at this whole issue more seriously and longer.  One of the things that hit me on all of these studies is because medical marijuana or marijuana is illegal the whole issue of how do you study the illegal substance without breaking the law.  And I think that there is a real barrier to understanding medical marijuana because research cannot occur as it ordinarily would.  Obviously, much of what we read was certainly challenging for a non-scientific reader and I really have great admiration for the scientists who are doing this work and wish them well and hope they continue.  But, just the nature of how the studies are done, they are so targeted, so isolated.  And I think that always, there could be, we would like to have more information.  But to me the real thing that hit me there is a lot of information.  There is need for a lot more research.  And the barrier because it is illegal and how the research can occur.
MARK ANLIKER:  I find myself this morning wishing I had sorted the stacks of information, you know, whether it was provided by the public, provided by the Board, regardless of its source, I wish I had sorted it into two piles, smoked marijuana and cannabis based medications.  Because the vast, vast majority of what we received is cannabis based medications and that's not what we're dealing with this morning.  We're dealing with smoked marijuana.  The smoked marijuana studies, to my recollection, specifically in glaucoma and nausea, talked about over medications.  There were very limited information with smoked marijuana versus the Zofran kind of product, we're talking Haldol, we're talking Procloprazine.  There were some significant dosages of Dexmethasome in some of the studies, so that's more current than the other.  But that I found a little disappointing and disconcerting.  The glaucoma with the cannabis based medications, some of the eye drops, I noticed they were using pumps which, you know, microliter kinds of drops continually into the various animal eyes they were doing these studies on which addresses my original concern about the length of effect of those medications.  I did notice that in the pain medications the currently available marijuana tends to have a biphasic response on pain relief.  And, again, we deal with all kinds of pharmacologic effects, but I thought it was interesting that you get a biphasic pain relief reaction from marijuana.  And maybe that's a point for smoke, because its easier to titrate than the orals but that's part of the whole discussion on having smoking.
ANNABELLE DEIHL:  I'm not sure what you mean by biphasic.
MARK ANLIKER:  Lower doses...  Let's see, low dose, in the study I think I'm recalling, had no effect.  Intermediate kind of dose in that study potentiated opioids.  The higher dose actually made the people hyper-analgesic.  They got more pain than they did..., more pain from the painful stimulant that they're using in the study than they did from the pain with no use.
VERNON BENJAMIN:  Got anything else? I was looking for this one page and I found it.  And this is hard to find.  The page you're thinking about in all the stuff that we have.  In this one article it said the Controlled Substances Act schedules certain types of classes of substances, not specific products.  And although new medications undergo a schedulign analysis as part of the FDA approval, placement of the substance in Schedule II is not sufficient to allow a specific product containing the substance to be marketed and distributed directly to the patient.  Basically, what that's saying is if something is put into Schedule II that doesn't necessarily mean that there's been approval for that product to be used.  It goes on to say that then the DEA has to determine whether it has acceptable medical use, and then it has to determine from all the studies of qualified experts and scientific evidence that the product actually is a product that can be approved by the FDA.  So, I guess as far as scientific knowledge regarding marijuana, I think that's part of what a lot of the scientists and that out there are asking for is for us to reschedule it off of Schedule I so that they can have access to it so they can do the studies, so they can develop the products that they feel will target a specific medical problem.  And, I guess this one paragraph here explains a lot of what, the rationale and the reasoning why we are trying to do what we are trying to do.  A lot of the people want to do experimentation on it but they're holding back because of the fact that it is a C1.
ANNABELLE DEIHL:  Now, correct me if I'm wrong.  The FDA can approve studies.  Some.
VERNON BENJAMIN:  Yes, they could actually provide the marijuana if they...  If somebody wanted to do a study, the FDA could actually give them, legally give them the marijuana for that study.
MARGARET WHITWORTH:  What's the process to get that approved to do it, though?
VERNON BENJAMIN:  I haven't done that before.
SUSAN FREY:  Actually, I think its the DEA that provides the marijuana.
VERNON BENJAMIN:  Probably, yeah.  They would be the one.
SUSAN FREY:  It was my understanding, as Class 1 experimentation can be done on it.
VERNON BENJAMIN:  Uh Hum.
SUSAN FREY:  So that process, that's how they get, those people that have done the research, that's how they have obtained it is through going through the DEA process for study on a Class 1 medication.  I don't think we have to reschedule it to Class 2 in order for experimentation.  That's already, I mean that process is already in place.
VERNON BENJAMIN:  That's one of the criteria that a lot of the experimenters are saying.  If it could be a Schedule II they could be able to do their experiments a whole lot more...
EDWARD MAIER:  I think one of the comments that I read somewhere is that it is able, you are able to get it from the DEA, but it has become a very difficult application process and very few of those applications are approved.
VERNON BENJAMIN:  Number 4 on our list is the history and current pattern of abuse of marijuana.  Basically, its two things there.  It's..., what's the history of marijuana?  Has it been used in the past?  And what's the current use of it and abuse that we see today?  Put the pressure on Sue again.
MARGARET WHITWORTH:  She's doing fine.
SUSAN FREY:  Well, actually, I think if anywhere that our information was probably lacking, this is the one area that it was lacking in.  I, we all have, you know, the historical part of it.  I mean, basically, the information has just been looking at, or has been over and over that it was taken off the federal register by the FDA.  We really didn't have any information, or I didn't find any information, that addressed that historical abuse, nor did I, outside of, I think that one piece of information from the FDA considered, that talked about the current pattern of abuse, where they were mainly talking about the adverse reactions, that they are seeing an increase in admissions to mental health facilities, or mental health services, because of adverse reactions.  And I think maybe if I recall there was something from California information that they were seeing an increase in the number of prescriptions that were used in a younger, healthier population than what was expected.  That's what I recall for information on that subject.
EDWARD MAIER:  I really don't have a lot to add to that.  Yeah, I, this was a disappointment to me that we didn't have better information than that, what's actually happening and the patterns of abuse.  And of course the argument can always be made that, you know, its abused because its classified the way it is so any time anybody uses it its a circumstance of abuse.  But, yeah, I did catch that one part.  It's interesting in California that the users, there's a really high group of younger, healthy people who are using it, medical marijuana.  So, that's an interesting kind of, piece of information.
MARGARET WHITWORTH:  I think this whole issue is surrounded by myths and stereotypes.  I think that there are overwhelming cultural implications and have been historically tied very much to racial and ethnic biases.  Generationally there are significant changes in attitute.  But, I think that, you know, we don't have a lot of historic reference.  It is also frought with political and ideological implications of when things are moved through the system and something is moved from schedule to schedule then the laws change.  And I don't know that the Board of Pharmacy is necessarily the best place to get the thorough cultural history of some of these products.  But it is, that I think is a very real issue.  And that is not going to show up and the implications are not going to show up in terms of any of our scientific studies.  It also is having a more than a bit of emphasis here in what we are studying today and what we are discussing and the whole idea of, that there are, you know, definitely we all have our biases.  Some people are freer to admit them than others.  But they are in fact biases.  And we all have our own cultural baggage.  I think there is great confusion in the discussion now that we're here to legalize marijuana, which we are not.  We are here to basically handle almost a technical adjustment in a legal process.  And, that is certainly something, and anyone looking to write a dissertation in a number of different disciplines I would encourage them to consider this and we can add to our scientific knowledge.  Because that it's simply something we don't have.  It wasn't in the material.  That is not a criticism of how the material was gathered or anything else.  But, we certainly are surrounded by myths and stereotypes in this as in many other issues.  That's the public member speaking.
EDWARD MAIER:  I don't think it has anything to do with the amount of material.  I think the material's probably not there.
MARGARET WHITWORTH:  Well, much of it is not.  Yeah, I would totally agree.
EDWARD MAIER:  It's unfortunate.  It's just not...
MARK ANLIKER:  I'd go along with what Peggy said.  There are huge implications, huge amounts of it with this whole discussion.  One easy way for me to pigeon hole it was alcohol prohibition.  You know, you make it illegal and all of a sudden its a panacea.  It's everybody wants it.  You know, I think there's a fair amount of comparison there.  Is it a straight up comparison?  No.  But, in my mind there's a tie together in that issue.
ANNABELLE DEIHL:  I'll pretty much go along with what Peggy said, too.  There's so much of this myth and cultural attitude mixed in with what we have, that it's hard to look at it.  I have found it very interesting, just people coming up to me on the street in little Osceola and saying, first, like you said, how are you going to change that law?  And then I explain that we're not going to change the law.  But, there doesn't seem to be any happy medium in opinions.  It's you better do it this way or you better do it that way.  I've been surprised at the responses with the people that I've known for years that I've never discussed this with.
MARGARET WHITWORTH:  I think we will be called evil no matter what.  We've been called a lot of names all day.  That's what we do.  We'll probably be called some of the same, but probably some new ones.
ANNABELLE DEIHL:  You might be right.
MARGARET WHITWORTH:  I hope they get more creative.  The last names are so predictable.
MARK ANLIKER:  This is sort of like the divorce proceedings.  There's his story, her story, and then there's that middle ground which is the truth.
VERNON BENJAMIN:  You are right about the amount of history that was in here, there wasn't much.  But if you do take what is available, just because of the fact that they didn't write about these drugs didn't mean they weren't being used.  I think that there was several different places where it made reference to the use of marijuana throughout history and how it particularly wasn't that big of a problem in society until, I think Sue that said, politically, and, I guess it was Peggy that said, politically and ideologically a wrong thing to do.  I think there is a pattern of history for it that it, up until that point it wasn't that big of a problem.  And I think it currently is being abused just because of the fact that it is illegal.  Just like, as a comment was made earlier about the young kids trying to get the alcohol.  If its illegal, its going to be something that they are going to seek after, probably.  In the California situation, as soon as the federal government said they weren't going to be pressing so hard because of medical users, the average age of the user in California went from 42 down to 24, which means that you still have those older people who are still in the mix but there has to be a lot of people under 24 to draw that number down to 24.  So, I think, there, their situation and the way they have their medical marijuana program set up leaves an awful lot to be desired and I would not want to be a board of pharmacy member or anything like that in the state of California.  They didn't set their rules and regulations up tight enough to begin with to make sure that their issues didn't become problems.
EDWARD MAIER:  I think a lot of the stigma that comes with this polarizing thing about people being on one side or the other...  The stigma is the recreational use.  And we're not looking at recreational use, we're looking at medical use.  Unfortunately, there are times when that line becomes blurred, and that's an unfortunate thing, but it has happened when things were not done correctly.
MARK ANLIKER:  My thought was that those documentation that we received, that the forums were almost 100% for marijuana.  The documentation that we received, whether it was emails, letter, communications of any kind, my estimate is someplace 30% or more were just people who wanted to smoke pot.  They had no aspirations about the medical issue.  They just wanted to smoke pot.  It's hard to separate those out, because there were some interesting comments from the pot smokers, if you will.
VERNON BENJAMIN:  It's good that you said what you just said, because what I, this one other piece that we got, it was a comment from the Institute of Medicine.  They stress that the purpose of the clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as the first step toward the development of non-smoked, rapid onset cannabinoid delivery systems.  The FDA agrees that herbal cannabis is not a medication and that the long term prospect of smoked herbal cannabis as a medicine is almost nill.  So, it's probably the easiest way for them to experiment on it is to smoke marijuana now to find out what the ingredients of the smoked marijuana are actually having the effect, but probably in the long run that's not where we're going to where we have smoked marijuana be a medicine of sorts.  Its what it is right now.  And what they're tring to do is use the information they gather from the experimentation on the smoked marijuana to develop drugs that actually target specific disease states and at doses where they can become medicine.
The scope, duration, and significance of the abuse of marijuana.  Discuss that.  Anybody have any comment they want to make on that particular point?
MARK ANLIKER:  5 and 4 are tied together in my mind.
VERNON BENJAMIN:  Number 6.  It's probably a big question in a lot of people's minds.  The risk to the public health of moving marijuana to a different controlled substance schedule.
MARGARET WHITWORTH:  I think this also gets to one of those things of what it is we're really dealing with here.  And the risk to the public health of moving marijuana to a different schedule I think is probably not so significant.  What we're talking about, what is the risk.  I mean...  But what most people are concerned with is is what is the risk to public health in terms of the delivery system, the controls, how would all of that be established.  And then, of course, taking the leap to, you know, the whole legalization of marijuana position, not what we're dealing with today.
VERNON BENJAMIN:  Well, just so everybody in the public realizes, what these are, is these are criteria that the Controlled Substance Act tells us we have to judge the basis of our decision.  So, all these things, we have to be, say yes we agree with all this stuff that it does fall within the boundaries of these definitions and therefore we change it to a different schedule.  So, that's why each one of the points we're discussing individually.  And I agree, too, its not public health really, it a small portion of the people that are wanting to use the marijuana for medical purposes, so its not even...
MARGARET WHITWORTH:  Its a very valid point, but in terms of the narrow discussion, or the narrow issue we're considering today its not that great.
VERNON BENJAMIN:  If we were talking about scheduling opioides, that's for everybody.  This is not going to be for everybody.
SUSAN FREY:  Well, I guess, I would take a different tac on that.
MARGARET WHITWORTH:  That's just fine.
SUSAN FREY:  Exactly.  I think as we're making this recommendation, we do have to look at the bigger picture.  And the bigger picture is that if you, in my mind, if you allow for medical marijuana, then that becomes a medicine.  There is a risk to public health if you allow smoked marijuana, then where do you practice that?
MARGARET WHITWORTH:  Bingo.
SUSAN FREY:  Does it practice, do you...?  I mean, you can't restrict it to a patient's home.  How does that effect...?  You know, are we going to allow a person walking down the street to smoke marijuana?
MARGARET WHITWORTH:  See, I think that that's a good valid point.  With the change in smoking laws in Iowa recently adopted, there, you know, its sort of like yes you can, however no you can't.
SUSAN FREY:  Right.  You know, we could not, we could not...  You know, in my mind you could not restrict a diabetic patient from injecting themselves in a restaurant.  If it's a medical necessity, how do you restrict that use?  I think the risk to public health is very valid.  If I were a person with young children, I certainly would not want them exposed to someone smoking, anything.  And, so, you know, I think that's a very valid point.  I think that is something we really need to look at, that there is a risk.
EDWARD MAIER:  Another things is that is, as I recall, at the Council Bluffs hearing we listened to the gentleman from Israel who was very pro medical marijuana.  Well, he did make one caveat, I would never let anybody drive while using medical marijuana.  That's public health.  I mean that is a public health concern.  So, you know, as we do this, consider this, we have to consider those things.  And a lot of that depends on how it's controlled.
MARGARET WHITWORTH:  And you are looking at it, clearly, public health in the, you know, language has different things.  And your points are extremely valid and I'm glad that you raised them.  And, you know, how many substances are there for which you get a doctor's prescription filled at a pharmacy that come with a disclaimer of do not operate heavy machinery but are the heavy machinery cops out there looking for you when you do it?  No, I'm really serious.  How do you?  How are those things?  And, I guess, we need to, and you can't legislate common sense, which is really unfortunate because that would be a good law.
MARK ANLIKER:  A couple of thoughts.  We're not changing the driving under the influence regs.  You can still get picked up for alcohol.  You can still get picked up for more tab, those kinds of things.  It seems that at least a number of the states had time or place and distance restrictions similar to, I'll use the child abuse registry people, not within so many feet of a school, not on public transportation, not on, there were a number of those caveats or regulations, and so I think we've got a legitimate issue but I think it can be dealt with in regulations promulgated by whoever gets to promulgate the regulations.
EDWARD MAIER:  But, unfortunately, those are not things that, if you look at it in a pure sense, that we have in our responsibility.  Our responsibility is to decide whether to change it or not.  We can make a lot of comments, but the bottom line is, you know, our decision is to change the schedule, but...
MARK ANLIKER:  I will toss out one thing.  Typical hospital campus, you can't smoke on the campus.  If they've got an oncology floor, and if medical marijuana comes to pass, what are they going to do?
EDWARD MAIER:  They are going to have to use a different.
MARK ANLIKER:  Remember those old bunkers that used to be on along the edge of the property where they'd send people to smoke?
EDWARD MAIER:  I don't know.  I'm just...
VERNON BENJAMIN:  I'd say, for me, it would be what's the relative risk of marijuana to the public health as compared to like opiates?  Is marijuana then, if we use it, does it incapacitate you more than what, say, like Vicodin does?  Or does Vicodin have more of a sedative effect such that you can't drive?  At least, from what I've read, is its probably less negative effects than what you could be dosing yourself on using opioids.
ANNABELLE DEIHL:  Strictly to the person who is using it?
VERNON BENJAMIN:  To the person using it, yes.  And I agree, too, that a lot of the states have that in their laws, they restrict the usage and I would recommend that whoever in the legislature puts together, drafts the legislation, if that would be the case that they would make sure, I'm sure that discussion will all be dealt with if it does come to that.
SUSAN FREY:  Well, Ann, did you have any other?
ANNABELLE DEIHL:  Well, I have a question, that just all of a sudden, in my mind, if we're talking about changing the schedule, are we talking about changing the schedule for smoked marijuana only?  Or like how the mist does it?
EDWARD MAIER:  Just for marijuana.  It doesn't say anything about the delivery system.
ANNABELLE DEIHL:  So, you take the whole thing.
VERNON BENJAMIN:  Marijuana in its raw form.
ANNABELLE DEIHL:  All right.  Well, I tend to look to look at public health in a bigger scope than just the person using, so...  But, there again, we're not here to decide how its managed, if we change it, which gives me a little concern if we change the schedule.
VERNON BENJAMIN:  Okay.  We're doing number 7 and number 7 is the potential of marijuana to produce psychic or psychological dependence liabilty.
SUSAN FREY:  In one of the studies, I think it was probably addressed very well.  It was, and I don't have the particular one to cite, but it was in, they looked at use of the oral THC, smoked marijuana, and a placebo.  And, in that study they, and I think they were using it for nausea, that they found that the smoked marijuana and the oral THC were comparable, if the THC was dosed appropriately.  And, I found interesting in that study that the comment was made that one of the issues that they found was that, number one either the physician did not ask about the patient's previous marijuana use and the level of that use, or that the patient, or the study person, study recipient, was not forthcoming in their previous use.  And, that, because tolerance can be built up, that the reason a lot of times that the oral THC was not effective was because that, it wasn't dosed appropriately, because that tolerance level had been, because the previous use, tolerance level had been built up and so they were actually underdosed.  And, once they figured out that issue, then the study came, took a little bit of a different turn, and they realized that the oral THC and the smoked marijuana were both effective and that the immediate relief that has been associated with smoked marijuana was not really any different than a person that was stabilized on the oral THC.  And, so, to answer this question, yes, definitely there is a physiological dependence because you do have the build up of tolerance and it does require, you know, eventually, it does require more medication to get the same effect.
EDWARD MAIER:  It's what I noticed, too.  Any time you have something that it takes more, more and more.
MARK ANLIKER:  It's true of the opioids, too.
EDWARD MAIER:  True, the opioids, too.
MARK ANLIKER:  And, in a number of medications.  I remember one of that stack of that stuff, talked about if a patient was stopped immediately, cold turkey, if you will, that it was very similar to a nicotine withdrawal, that after about a week you were through with those kinds of things.  Now, I've got a patient who I believe to be a cannabis and former cocaine user and he says cigarettes is the hardest thing he's ever quit and he's done it multiple times in my practice life.  So, that's again a plus and minus kind of thing, as most of these are.
SUSAN FREY:  And that's not to say that that's necessarily a bad thing.  I mean, I deal with long term care residents.  I deal with long term care pain and we deal with that tolerance.  And its not, you know, I don't want to give the impression that I think that that's necessarily a bad thing.  That, you know, you're going to have, you know, its just an escalating, escalating thing.  That doesn't happen rapidly, its a slow process.  But it does happen.  And that's one of the criteria of making a drug either..., a physiological dependence.  I think that was supported in the literature.  The psychic dependence.  There again, that one...
MARGARET WHITWORTH:  We didn't have, you know, any specific...
SUSAN FREY:  Yeah, we didn't have a study, we didn't really have studies that really looked at that psychological dependence.
MARGARET WHITWORTH:  I think the other thing that's a bit of a challenge in the way these questions, or these points, are made, the potential for marijuana to produce, you know...  You can substitute a lot of other words.  We are dealing with the other words.  We're dealing with that end right now.  And that's something that I have to remind myself of.
VERNON BENJAMIN:  Okay.  Does anybody want to take about a 5 minute break?
MARGARET WHITWORTH:  That would be great.
VERNON BENJAMIN:  We'll start back up at 10 after 10.  10:15 at the latest, okay?