The California Compassionate Use
Act, CA HSC §11362.5
Medical Board of California
May 7, 2004 Partial Transcript
JERZAK: Okay. The next thing I want to talk to you about is that we’ve got an invitation from Congressman Souder, a Republican from Indiana, who invited us, the Medical Board, to send a representative to testify before the House Committee for Government Reform. And it was a subcommittee on criminal justice, drug policy and human resources. I have…copies were distributed to you in the mail about needing to prepare a five-minute written testimony to give before the panel members there.
This is a fact-finding mission by Congressmen Souder to, I think, explore the states that currently have medical marijuana laws and to look at what the issues are, especially since about five more states are now considering laws in this area. So the testimony that I gave to them was limited to the statement here and I responded to some questions. But there were two panels there. And the first panel was composed of representatives from NIDA the FDA, and the DEA. And the thrust of the testimony was that marijuana has 483 components. And all of those should be studied individually by FDA in order that… their standard is to prove that they’re safe and effective, much like Marinol had been studied in trials and produced to become a prescription drug. And that has not yet been done for the components that remain in marijuana. And that they also said that smoking has been deemed to be hazardous to your health, so why would some medicine be given in that form, in a smoking form when it has already been determined to be hazardous to your health?
There were other things that were said by the FDA and DEA about the limited amount of studies that are currently underway, but I was asked to sit on the second panel where there was a representative from Oregon one of their Board Members came there asking what our statewide… how we look at this and how we responded to the federal question. We basically responded that we had California law in our Health & Safety Code that was initiated by the Compassionate Use Act of 1996, and felt that voters in the state felt that this was necessary to be able to have another option for those patients that were seriously ill and those patients that had certain ailments, and for other illnesses that were deemed appropriate by the recommendation of a physician, holding the physician as gatekeeper to determine when marijuana will be an appropriate recommendation for a patient. So I described our cases that we had, in a general sense, that we were looking at quality of care and that our experts had not been critical of marijuana as a recommendation per se, but they had been more critical of the context of the medical care that had been provided in those cases.
There was some discussion by the proponents of marijuana. There was some other… there was a physician, Claudia Jensen, who has given marijuana to juvenile patients who have ADD. Although there really wasn’t time in the discussion to explore even mechanisms of how marijuana is delivered. I think it’s assumed by the Congressman that smoking is the only delivery source. And there are a lot of other routes of ingesting it, there are routes of steeping in a tea, which is what Dr. Jensen does. Now she has two patients in her practice, as I understand it, that have derived some benefit, rather than everybody in her practice getting marijuana. So it… there’s a lot to be said about what was limited testimony and what was not said.
We have had some follow-up questions from that Committee, asking us until May 12th to respond in writing to some follow-up questions I've given you in that document this morning about the follow-up questions, so we have not yet completed that. But there is a lot of interest on the national level of how they want to respond to this. Of course, they’re looking at the federal response of what… And although we’re a state agency we have to be mindful of these discussions are ongoing and that there’s still time to develop policy by their DEA staff as to how to respond to the states where this exists and where there’s conflict there. So I just wanted to bring you up-to-date on that kind of a unique visit.
Wender: Any questions?
Wender: You will provide us with your answers to these questions, won’t you?
Jerzak: Yes. That’s going to conclude my report.
Wender: Thank you. Which is the segue into probably the hot topic of today, the Medical Marijuana Task Force. I would like to start the discussion by thanking the members of the Task Force: Dr. Lucks, Dr. Breall, Sandra Bressler, Alice Mead, representatives from the Attorney General’s Office. This is not an easy task.
The document that we’re going to present today is really a statement of the Medical Board. Eventually we would like to have a joint statement with the CMA. The discussions will be ongoing. The door is not closed. I look at this as an evolution of a document and not the ultimate document. However, like so many things that we do, if we don’t have at least a statement out there this could go on for years. We could be discussing this five years from now, about eventually we’ll have the perfect document. So this may not be the perfect document, but I do think it reflects the general thinking of the Medical Board, which was my intent when I initiated this task force all along. This is not meant to be a manifesto on the use of medical marijuana. It does have a reference to the CMA website where’s there’s an excellent document which I think is about 17 pages. This is simply a statement from the Medical Board saying to the physicians of this state that if you recommend medical marijuana and you do it in an appropriate fashion to me, such as… in the same fashion that you might recommending an anti-hypertensive, that you will not face prosecution from the Medical Board. Obviously, we don’t have any control over the federal government and its policies. And that’s what this is meant to be. Not the ultimate, not the perfect document, but a document in transition where we will continue to talk, we will reconstitute the task force to see if we can make it better. But I know that many of you in the audience have been anxiously awaiting something from this Board and we would like to get that document out to you. And we certainly will take comments from you, preferably in writing, because we won’t have time for public comment. But if you do have pertinent things that you think could make the document better, we would love to have those in writing from you. Linda has done yeoman’s work on this. And I will turn it over to Linda.
Lucks: Thank you. Actually, I want to thank all the people who’ve participated in this process, which started in November of 2002 when the disciplinary guidelines were distributed to the Board, the DMQ, which actually made the recommendation of marijuana a disciplinary offense, lumping it in the prescription medications as background. I took issue with that document, a draft document, and pointed out that it really was an unfair thing to try to lump it together. And at that point Dr. Wender invited Tom Ungerleider, Dr. Tom Ungerleider, a psychiatrist, Lyn Brown, a marijuana researcher and member of the 1972 Nixon Commission on Drug Abuse, and Alice Mead, formerly with CMA, now with GW Pharmaceuticals and an expert in field to address our views, our [...unintelligible...]. Both of them are here today. Thank you so much for coming and thank you, Dr. Ungerleider and Alice for staying with us all this time.
They addressed the group to educate us on the history and issues and research, and the confusion surrounding medical marijuana, to inform us and educate us, so that we could move forward in a progressive direction, which we have done. It’s been a long process. We were hoping to in our initial working group to come up with a joint statement with CMA, and we worked closely with Sandra and CMA to do this. We worked also with Deputy Board Staff of Enforcement… Sheriff, a Deputy Enforcement person Ana Facio and Mary Agnes Matyszewski. Subsequently, when we had a document for distribution in January of 2004, Dr. Wender appointed… or Dr. Chahabi appointed a formal marijuana task force which has been meeting since then, and we refined the language to really make it much clearer and more concise and readable, the purpose being to dispel fears by the physicians to inform staff of what was okay and what was not okay. And we’ve almost reached consensus. We don’t have quite consensus, but it’s a really giant step forward for this board and the people of California. So not everyone’s going to be happy with the language. But I’m happy that we’ve got full consensus and we have … within six months we’ll do it again, and it is an evolving live document.
I personally prefer that some of the references to prescription drugs be not included. I personally sided with CMA and Alice Mead to have the language be less restrictive. But in an effort to compromise and move forward, I’m going to move that the document before you with some modifications, which I’ll tell you, be accepted by the Department of [...unintelligible...] Division of Medical Quality and by the full Board, and be printed in the July 2004 Action Report. It will be a major step forward. And I hope at some point the CMA will join on and have a full consensus.
The language that… you have the draft document there before you. There are a few more changes I’d like to add to my motion. It’s not exactly as you see it before you. If you turn to page 2 [...unintelligible...]. [Paper rattling] I also wanted to thank [Coughing, paper rattling] [...unintelligible..], who couldn’t be here today, participated, and actually came up with the compromise language that we’re looking at today. And we also telephonically had participation by Joan Bathsari, over the last week.
So the changes from the document you see before you are not extensive. However, if you look at page 2, paragraph 3, "these accepted standards are the same as any reasonable and prudent physician would follow when recommending or approving any other medication or prescription drug treatment, and"… it will read that way. "and included the following" as read. And on…
Lucks: Right. ‘…Or therapy intervention in prescribing any drug that requires a prescription…’ And insert the same phrase [...unintelligible...] as in the paragraph under the number that would say, ‘Prescription drug treatment.’ [...unintelligible...]. Is that clear?
Lucks: Yeah, it’s right. That… the one above it, ‘Any other medication…’
LINDA: [...unintelligible...]. And then, again, one other change would be on page 3, number 6: ‘The initial examination for a condition for which medical marijuana is being recommended must be in person.’
MAN: As opposed to the word ‘should.’
LINDA: As opposed to the word ‘should.’ And it might be helpful to read the whole thing. [...unintelligible...]
MAN: We deliberately didn’t want to see a 10- to 15-, 20-page document. We wanted something that people could read, understand, and get to the point.
LINDA: Let me read it aloud, because I think the tone of it is really where we are going. And I’m quite pleased with it.
‘On November 5, 1996, the people of California passed Proposition 215. In this initiative measure, Section 11362.5 was added to the Health and Safety Code, and is also known as the Compassionate Use Act of 1996. The purposes of this Act include, in part (a) to ensure that seriously ill Californians have the right to obtain and use marijuana for medical purposes where the medical use is deemed appropriate and has been recommended by a physician who has determined that the person’s health would benefit from the use of marijuana in the treatment of cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, and for any other illness for which marijuana provides relief. And (b) to ensure that patients and their primary caregivers who obtain and use marijuana for medical purposes upon the recommendation of a physician are not subject to criminal prosecution or sanction. Furthermore, Health and Safety Code Section 11362.5c provides strong protection for physicians who choose to participate in the implementation of this Act… of the Act. Notwithstanding any other provision of law, no physician in this State shall be punished or denied the right or privilege… any right or privilege for having recommended marijuana to a patient for medical purposes. The Medical Board of California and…’
LINDA: We’ll cut out the California Medical Association at this point, ‘…work together to develop this statement… or worked to develop this statement since medical marijuana is an emerging treatment modality. The Medical Board of California wants to assure physicians who choose to recommend medical marijuana to their patients as part of their regular practice of medicine that they will not be subject to investigation or disciplinary action by the Medical Board of California if they arrive at the decision to make this recommendation in accordance with accepted standards of medical responsibility. The mere receipt of a complaint that the physician is recommending medical marijuana will not generate an investigation absent the Medical Board…the Medical Board of California and the…’ take out CMA… ‘…work…’
MAN: [...Unintelligible...] information.
LINDA: ‘…absent additional information indicating that… indicating that the physician is not adhering to accepted medical standards. These accepted standards are the same as any reasonable and prudent physician would follow when recommending or approving any other medication or prescription drug treatment. and includes the following: (1) history and good faith examination of the patient, (2) development of a treatment plan with objectives, (3) provision of an informed consent, including discussion of side effects, (4) periodic review of the treatment efficacy, (5) consultation as necessary, (6) proper record-keeping that supports the decision to recommend the use of medical marijuana. In other words, if physicians use the same care in recommending medical marijuana to patients as they would recommending or approving any other medication or prescription treatment, they have nothing to fear from the Medical Board.
Here are some important points to consider when recommending medical marijuana: (1) Although it could trigger federal action, making a recommendation in writing to the patient will not trigger action by the Medical Board of California. (2) A patient need not have failed on all medical medications in order for a physician to recommend or approve the use of medical marijuana. (3) The physician should determine that medical marijuana use is not making an acute or treatable progressive condition… is not masking, excuse me, an acute or treatable progressive condition or that such use will lead to a worsening of the patient’s condition. (4) the Act made certain medical conditions for which medical marijuana may be useful, although physicians are not limited in their recommendations to those specific conditions. In all cases, the physician should base his or her determination upon the results of clinical trials, if available, medical literature and reports, or on the experience of that physician or other physicians or on credible patient reports. In all cases, the physician must determine that the risk-benefit ratio of medical marijuana is as good, or better, than other medications that could be used for that individual patient. (5) A physician who is not the primary treating physician may still recommend medical marijuana for a patient’s symptoms. However, it is incumbent upon that physician to consult with the patient’s primary treating physician or obtain the appropriate medical patient records to confirm the patient’s underlying diagnosis and prior treatment history. (6) The initial examination for the condition for which medical marijuana is being recommended must be in person. Number 7, recommendations should be limited to the time necessary to appropriately monitor the patient. Periodic reviews should occur and be documented at least annually and more frequently as warranted. Number 8: If a physician recommends or approves the use of medical marijuana for a minor, the parents or legal guardian should be fully informed of the risks and benefits of such use and the parents’ consent to that use.’
MAN: Excuse me, just if I could stop you there for a minute. I’m not sure that’s a complete sentence or a complete thought at the end, so if you could just tell me what you’re getting at. Must the parents’ consent be obtained?
MAN: It doesn’t say that.
MAN: So the parents consent to that use…
LINDA: It must be obtained.
‘Physicians may wish to refer to the CMA’s on-call document number 1315, titled the Compassionate Use Act of 1996, updated annually for additional information and guidance.’ The website is listed there. [...unintelligible...].
LINDA: ‘Although the Compassionate Use Act allows the use of medical marijuana by a patient upon the recommendation or approval of a physician, California physicians should bear in mind that marijuana is listed in Schedule 1 of the Federal Controlled Substances Act, which means that it has no accepted medical use under federal law. However, in Conant vs. Walters, 9th Circuit 2002, F 3rd, 629, the United States Court of Appeals recognized that physicians have a constitutionally protected right to discuss with and recommend to their patients all potentially beneficial treatments. Physicians could exceed the scope of this constitutional protection if they conspire with or aid and abet their patients in obtaining medical marijuana.
[break in tape, tape changed]
MAN: Can we add something that says or recommends… something to the affect that you can recommend in writing to a patient?
Matyszewski: Yes, we can…
MAN: And we can add a phrase or sentence there, so that’s…
MAN: I just have concerns that we be as clear as we possibly can be [...unintelligible...] to know precisely where the line is so they don’t wind up accidentally on the wrong side of it.
Matyszewski: I agree with you there.
MAN: Thank you.
MAN: So I think we should include that and it’s clear. Any other Board discussion?
WOMAN: I have a question. Is Conant being appealed?
Matyszewski: Conant was appealed to the Supreme Court. They denied cert [...unintelligible...], which means they upheld the… so that means they upheld… and it does mean the 9th Circuit’s decision is final.
WOMAN: Okay. Thank you.
WOMAN: Was it your intention… in the last sentence, this leaves open for our board whether we would take action against a physician who… [...unintelligible...].
WOMAN: Well, this document basically says that we are not going to take action if a physician prescribes.
Lucks: No, recommends.
Lucks: Not going to take action. If a call comes in and somebody reporting, like a park ranger or someone who is arrested with a letter that is not going to trigger an investigation by this Board.
WOMAN: What if a call comes in that does say that the physician has violated this 9th Circuit decision, that, in fact, a physician not only has recommended, but has, you know, provided directions as to where to obtain or, actually furnish… do you know what I’m saying?
Lucks: Right. And it’s very specific that’s not a [...unintelligible...] that would warrant investigation.
WOMAN: For our board?
WOMAN: For our board.
Lucks: Merely the writing of the recommendation and following all regular medical protocols is not [...unintelligible...].
WOMAN: The practice of medicine, and you won’t have any trouble with this board.
MAN: I’m going to ask for public comment, and I’m going to start with Alice Mead and Sandra Bressler. And then do we have sign-up sheet?
JANE SIMON: Can I just make… I’m Jane Simon. I just wanted to make one quick comment. I think Ms. Rice’s point was the right one, and perhaps we should further state in there… because the [...unintelligible...] decision is distributing marijuana [...unintelligible...]
Simon: I think we should further explain it.
WOMAN: Well, I think it’s pretty clear to me that that’s what it says, that it’s not allowed.
[Several voices overlap]
Simon: Under federal law, but it… would that be actionable by the Medical Board? And I think it probably would be.
MAN: I think just a simple sentence that states this would be actionable by federal and by the Medical Board clarifies the whole thing.
Simon: Right. Your job is to medically evaluate [...unintelligible...]…
WOMAN: Right, right. I want just to be very, very clear. So, [...unintelligible...].
MAN: Do we have a sign-up sheet? If not, I’ll [...unintelligible...]. Alice, go ahead
ALICE MEAD: I’m Alice Mead, representing CMA as a consultant today. I would just like to respond to that particular point. There is a provision, Business and Professions Code states that a violation of federal law, federal or state law, governing controlled substances constitutes unprofessional conduct. But at least in my legal opinion, Proposition 215, the Compassionate Use Act, has by implication affected that statutory section, because under Proposition 215, there’s a broad immunity for physicians. And it is a more specific statute later in time than that statute. So, while CMA doesn’t encourage physicians to furnish or dispense or direct a patient to the nearest cannabis dispensary, in fact, it is possible that that would be permissible and not sanctionable under Proposition 215. So I don’t think it’s actually black and white, and I think it should be further considered before any changes are made to the language in this document.
MAN: All right.
SANDRA BRESSLER: I think Alice is going to have some other things to say subsequently, but she wanted to comment on that. Sandra Bressler, the California Medical Association. I would like at this point just to kind of give a background about how we came to be involved in this discussion that we’ve been having with the Task Force and where CMA has been on this issue of medical marijuana over quite a long period of time, including back in 1996 when it was on the ballot. And then I think Alice could talk to you a little bit more about some of the legal concerns that we have and some more things about the document.
When Prop 215 was on the ballot, CMA did not support it. And we did not for a number of reasons, but most particularly because we realized at the time that this was going to put physicians in the middle of a significant conflict between state and federal law and thought it would be complicated. And, indeed, we were correct in that assumption.
In addition, as a rule, I’m sure you all can appreciate and feel similarly, many of you, if not all, CMA has always been concerned about the smoking issue, and not particularly supportive of that as a method of delivery for any medication. And that concerning the [...unintelligible...] today, but is not particularly relevant to this aspect of it, the statement that we’re trying to develop. But just so you know, by way of background, some of the concerns we have.
In addition I think it’s fair to say that physicians and the CMA did not appreciate what the clinical and scientific evidence was for medical marijuana at the time that 215 was on the ballot as well. But when it passed, one of the things that we knew is that this is the law in the State of California, and we need to advise our physicians practicing in California adequately on a lot of things now that this was the law of the land. And so we set up a technical advisory committee to look further into the whole issue. And that advisory committee stayed in existence for several years, did a large number of investigations and considerations about medical marijuana and… including going to an Institute of Medicine meeting that was convened to explore the scientific basis for marijuana. And, in fact, visiting some of the distribution points in California that were distributing marijuana, and taking very seriously this as an explanation of the science and the clinical, and all kinds of concerns. And I’m not going to go into all that that group did and recommended, but suffice it to say that CMA’s policy has changed over this time because of a lot of exploration that that group did and recommended to our policy-making bodies.
Initially, CMA’s policy was to oppose the recreational use of marijuana and to support this medicinal use when scientific studies demonstrated its appropriateness. Since that time, I think that CMA is persuaded there is sufficient scientific evidence for its medicinal value, and supports its use in limited ways because of the distribution system, which is of great concern to us to have a drug distributed in a way that’s not normal, the way in which most drugs are distributed. And, also, because it is a smoked product, which is not something that we’re thrilled about. But we believe that the scheduling of it a Schedule 1 drug at the federal level is inappropriate, that it does have medicinal value, and, therefore, it’s inappropriately scheduled a Schedule 1 drug.
Having said that, it is not possible for us to determine what schedule or whether it ought to be scheduled at all. That’s a very complicated process, which has largely been impeded for political reasons at the national level. And so there’s still a lot to be done with respect to that issue and how it should be treated. And… but at the same time there are physicians who are recommending it in California, and CMA has a great interest that those physicians be treated appropriately and with respect to California law, and has done a lot to try and promote that, including participating in these discussions to clarify what the Medical Board’s attitude and, in fact, actions are going to be with respect to physicians who do recommend marijuana. And we are under a mandate to work with the Board on this from our house of delegates of two years ago. And that is what got us involved in this discussion.
I think we would always prefer more clarity than less. This has been difficult in devising on a statement that we could all agree upon. And as you can see from the original document that was distributed to you that we… and this is, by the way, we as those who participated in the Task Force, were willing to take further in the CMA policy-making apparatus the statement that was originally distributed to you. So at this juncture, we were not prepared today because if this statement hasn’t really been vetted through our process and have a lot of internal comment. We are working with the Board to develop a draft, but then we could distribute for much broader comment within CMA. So independent of whether you decided to accept the language that we now don’t have consensus on or not, we were not prepared to be able to sign-on to this document today because it still needs review. And I cannot tell you how that process will come out. We will do it, and, you know, we’ll move forward with you in this Task Force that you have continued, and work on trying to reach some kind of an agreement on the document that will, you know, can be altered or amended or signed onto as time goes by.
Wender: I think that’s really a good intent. That this is… they will… we hopefully will come out with a statement today, that we will look at this as a work in progress, and look forward to working with both of you to eventually have something that is… that both organizations can agree to.
SANDRA BRESSLER: And we’re committed to working with you and will do so. So that… any questions?
MAN: Sandra, I listened to your testimony carefully, and I’m trying to read between the lines to make sure I’m forming an opinion properly. The draft language that we had on May 7th that had had a chance to go through the CMA process and that was agreed on language, and it was the edits that we did today that put it out of compliance?
Bressler: No. No, not at all. And I wanted that to be clear.
MAN: So neither [...unintelligible...] had a chance…
MAN: Okay, based on your reading of the tea leaves, do you think we are very far apart? And, if so, do you have an insight as to what areas might be at variance.
Bressler: Well, I think that the area that we could not, you know, achieve consensus on is likely to be of concern. I can’t predict how that’s going to come out because we haven’t really discussed it with…
Bressler: Well, I think that the language that we have bolded and said is of concern to us in the document that you originally received is problematic, at least from our perspective, and we believe may well be from the perspective of CMA when we discuss it. But, you know, anything can happen. And Alice wants to say something, so let me…
Mead: Well… because it’s relevant to… we’re trying to focus on what might be the primary concept concern or disagreement. And I… I mean, to my reading, it’s primarily holding physicians to an explicit prescription drug treatment standard. And I think there are several legal concerns with that, that I’d just like to go through quickly that I think will be of concern to CMA.
The first is, and I don’t' have to tell most of you, that under the Federal Food and Drug and Cosmetic Act, a drug subject to… by prescription only when the FDA determines that it’s sufficiently toxic or otherwise dangerous in its form of use or in its constituency that it can’t be dispensed by a pharmacist unless a patient is under the close detailed supervision of a physician who is licensed to administer it. Now, in deciding whether to prescribe medication like that, the physician has to do a prospective on anticipatory weighing of the risks and benefits for that particular patient. And in doing so, the physician decides what dosage form, what dose, what dosage regimen the patient should be on—that’s all part of the prescription. The patient can’t get the medicine except from the pharmacist through the prescription, and the patient can’t get more than the prescription allows. This is not the model that the Compassionate Use Act establishes. Under Proposition 215, the physician doesn’t have that kind of close supervisorial authority or responsibility. It doesn’t give the physician the authority to administer it, it doesn’t give the pharmacist the authority to dispense it. The Act places the control of the manufacture and/or the procurement of the medicine in the hands of the patient. Patients can cultivate the medicine themselves. They can determine the route of administration. They can determine the dosage that’s best for them. So it seems to me that the people of California in enacting the Compassionate Use Act, have determined that medicinal cannabis is not a toxic or otherwise dangerous drug that should be subject to the prescription drug standard.
WOMAN: Excuse me.
WOMAN: I think that’s really a leap.
WOMAN: I mean, I don’t think that the people of California… and I don’t think that was an issue that was [...unintelligible...].
Mead: But when you look at this structure of the system that Proposition 215 establishes, in fact, it’s the patient that has most of the control…
WOMAN: Correct, I agree…
Mead: …over the medication. And that’s unlike any other prescription drug.
MAN: I think she’s taking more of an unintended consequences argument, and when they enacted 215, they were looking at a particular thing. But if we take the medical prescription model and there’s a whole lot of other things that get folded in here sort of accidentally, as it were.
Wender: I think that the reason for it was that it would be very difficult for this Board to come out with a statement which did not… which lowered, let’s say, where we thought medical marijuana was, that this was not comparable to ginseng, but it was at least as comparable to a. you know, recommending an anti-hypertensive. And that we really wanted it within a context that if a physician is going to be held responsible, in great detail, to what is recommended, that there should be due diligence, at least in the same vein as recommending an anti-hypertensive or a proton inhibitor for gastric reflux. That it really wasn’t the same as saying, ‘Okay, we recommend massage therapy or why don’t you get some glucoamine and chondroitin at the health food store.’ And I think that’s really where we’re in sort of somewhat in conflict. That I think we would be as a board in a very difficult position if we just put it on that level. I’m not really suggesting that. But I think, you know, this is certainly the area for further discussion. I think that we need some feedback from the CMA, from the medical people, and we look to resolving this in the future. But I think we would be in a difficult situation to be taken seriously if we really just kind of said, ‘Well, okay, you recommend it and it’s up to the patient to do whatever the hell they’re going to do.’
WOMAN: I would venture that we would all need to remember that we are treading on very new territory. And it’s better to have something out there that we can take a look at and change and manipulate to make it work for us than to have nothing out there at all. So from that perspective, I really want to thank the Task Force and community for working together, but I think that what we need to be very careful of is looking at every word under a microscope and how it’s going to impact or how it’s going to affect whatever might happen. Might happen is a lot of Hollywood, and we don’t need that. What we need is real and tangible. And I think that what we see in front of us is really a remarkable document.
Mead: I think one concern we have about using sort of a blanket prescription drug standard rather than, say, an anti-hypertensive or, you know, something that may be an intermediate is that there really is no global standard of care for prescribing prescription medicine. I mean, it really depends on the patient’s medical condition and the particular medication that’s in question. Some medications are so prone to produce adverse events, where there’s allergic reactions or organ toxicity that they require very close monitoring. And they should really only be offered as a last resort. There are types of prescription medicines like that. So what you do is you put up an expert who’s experienced in that patient’s condition and the use of that medication. But there are not experts for the use of medicinal cannabis. And, therefore, to use a blanket prescription drug standard gives the board, frankly, very broad discretion to use in a medicinal cannabis case without the requisite expert opinion to inform and make that standard more appropriately specific in a particular patient.
MAN: Well, my pledge to you is we will work on that together and see if we can’t fine a place that’s better.
Bressler: And just in response to your comment about needing to get something out, I hope that you will all listen to, because we were asked to tell you what our concerns are. This is an educational function, independent of what you may do today or with this document. But you asked what our concerns are. We’re trying to let you know what they are, and hopefully help you think about it as well, because this is going to be an ongoing discussion.
MAN: And we appreciate that.
Mead: The final point, I don’t believe it’ll be too long, but the final point is, you know, physicians recommended medicinal cannabis before Prop… before the Compassion Use Act was enacted. The Compassionate Use Act didn’t authorize physicians to recommend medicinal cannabis. It just gave special legal affect following the enactment to a recommendation like that. Physicians had been recommending medicinal cannabis for quite some time for very… particularly for patients who were undergoing cancer chemotherapy. So this is not really a new thing. It’s just something the Board is now interested in. But it should be borne in mind that, you know, recommendations had been around for awhile. So…
Lucks: I just wanted to say that this is really a giant step forward, and not perfect and not… nobody’s 100% happy today. But my promise and the promise of this board is that [...unintelligible...] this document is going to help dispel a lot of fear and move us a hundred steps forward, and there’s only forward to go after that. So I really urge the physicians to adopt the language as amended, and hope that the full Board will do the same, and have it published the in July Action Report would do a whole lot to move forward.
MAN: I also would like to compliment the Task Force on an excellent document. I’d like to point out also that there are many prescription drugs where we do ask the patients to regulate the dosage themselves to a degree. We tell them to use it on a prn or as-needed basis, based on their symptomatology. We warn them about possible side effects, possible over-use. So that it’s not totally inconsistent. Yes, this is a drug that’s usually smoked rather than taken as a pill, which is a difference, but the prn usage and warning about side-effects, etc., is not an unusual situation.
WOMAN (?Rice): Just to… I don’t want to really lose the point that I had made earlier, and that was that if we’re talking about the issue of quality of drug, in which I said, you know, the importation of drug or a real concern[...unintelligible...] like that. How is that relates to this is what we said right now is the physician can recommend. And then the patient says, ‘Well, where can I get it?’ And the patient at this point may or may not know where to get quality marijuana, as opposed to, you know, adulterated or something like that. So my question is what would… is there any legal prohibition or restriction to even consider adding to this document something that would say that the Board will not proceed against any physician for directing the patient as to where to obtain quality marijuana.
WOMAN: Well, exactly, [...unintelligible...].
(Steve Alexander?): Laurie, if I heard correctly, though, I heard Nancy or Jane, somebody say we need to put in a couple more words in that end section t make it crystal clear that they cannot do that.
WOMAN: Well, it says that the federal law prohibits…
MAN: No, they said… they would put it in our language, I heard them say, [...unintelligible...]
MAN: It was also [...unintelligible...] Profession Code [...unintelligible...].
WOMAN: I know that, but what I’m wondering is, is there any allowance if we didn’t want to go in that direction to say that we will not prosecute those physicians who directs a patient as to where to obtain? So that they could recommend and they can say, ‘You can get it…’ someplace.
WOMAN: I think that would be perhaps something to be brought up…Task Force meeting. I think we have something before us that we need to…
WOMAN: [...unintelligible...] a copy of it, so you should hold that thought.
MAN: I’m going to take the Chair’s prerogative here and we’re going to take a 15-minute break. What I would like to do is delay the regulatory hearing. We have a long list of individuals to speak to this issue, to finish this issue, and then give the regulatory hearing. So it is quarter to 10. I plan to start promptly at 10 o’clock with public comment. I have a list. If some of you have not signed-up and wish to add to this list, we will be happy to do it. We will allow everyone on the list a statement…
MAN: …We’ll go through it and everyone will have an opportunity, but I would ask you to keep your remarks within a couple of minutes, please
WOMAN: Good morning, my name is…
MAN: Is the mike on?
WOMAN: Good morning, my name is [...unintelligible...?Anna Halloran?]. I’m here on behalf of Senator Vasconcellos. Unfortunately, he’s not available to be here with you. But he asked that I attend this hearing to share with you some of his thoughts about the guidelines that, I know, the Task Force people worked very hard over the last few years to put together, and he commends the effort.
As some of you may know, the Senator has being involved in the implementation of Proposition 215. And was… legislation was signed last year by Governor Gray Davis. He urges that the Medical Board move in the direction that’s consistent with Prop 215. The [...unintelligible...] main concerns by… raised by CMA, he would ask that you hold off in adopting the guidelines until consensus can be reached. It is his opinion that medical cannabis is not a prescription drug, therefore should not be treated as such.
And the last point is that he asked for you reinsert "therapeutic intervention" into the guidelines, [...unintelligible...] or prescription treatment.
MAN: Dr. Ungerleider.
Dr. Ungerleider: Good morning, everybody. I’m Tom Ungerleider. It’s a privilege to be here and see you all again. I want to say I think it’s a terrific piece of work that you’ve all done. And I want to say I think it’s a very important of work. And I think I would like to respectfully disagree with you and my good friend, John, we always disagree on things. I think now it’s important, and I think it’s important to say it, and to give physicians clear message. And not just in California. I go around the country and talk and I… I testify sometimes in various cases and people always say, ‘What’s going on in California? What’s the Medical Board doing?’ You really don’t realize how important this is to doctors, in general. And if you try to wait for agreement, you’re going to wait forever. I’m telling you, I’ve been waiting since 1971 for marijuana to be rescheduled. And we recommended it…then when medical proof came in to be rescheduled, none of the work had been done in 1971, a very close friend of mine was our Executive Director on the Presidential Commission. He was the one who was BNDD. which is a DEA predecessor, had written the Controlled Substances Act and he said, ‘I can’t believe…’ He said recently, ‘we’re still on Schedule 1.’ Through criteria, you know, it’s unsafe when given by a doctor, and its more of a drug of abuse than any other drug in the Schedule 2, that kind of thing. And no medical use… it’s just impossible. You’re going to wait forever.
So I think it’s really important that what we’re talking about, and my final comment, is something that no law [...unintelligible...] can spell out. And that’s clinical judgment, that clinical judgment of the physician. Everyone of you physicians knows what we’re talking about, that means you decide what to do and in what context and when to pick something out. That you’re now adding to that and spelling out what the right things are when you’re doing a prescription. And you say it’s not a prescription. Well, it really is a prescription medication the way we’re talking. And it is going to be a prescription medication, even if it goes down to Schedule 2, or whether it belongs in 3 or 4. You still have to keep records and do the right thing. So congratulations [...unintelligible...].
MAN: I’m going to go through the list here. William McKenny? Is he here? Frank? Where’s Frank? Frank?
MAN: Frank Lucido?
FRANK CUNY: Frank Cuny, California Citizens for Health. I had the opportunity of hearing almost the same dialogue, but not a written thing about eight years ago in San Francisco at a Medical Board meeting to the supporters of marijuana. Saying the [...unintelligible...] Medical Board defines at that point. This is what we’ll do… You know, practice good medicine with [...unintelligible...] I support the committee effort. Thank you.
MAN: Bob Flowers? Julie?
MAN: Frank Lucido?
FRANK LUCIDO: Members of the Medical Board of California, the Division of Medical Quality, I’m going to make some of the points I made before, but I’ll be brief. Number one, medical cannabis is safe and effective. There have been no reported deaths. I’ve given you ample evidence of the effectiveness of it at previous times. Number two, law enforcement’s cultural bias that I’ve mentioned before. I’ve checked again on the website, and have told you this each time, the website of the California Narcotics Officers Association as of yesterday still says, ‘There is no justification for using marijuana as medicine.’ This lie is clearly contradicted by the Institute of Medicine’s own 1999 report, the federal government’s report. So, again, just be aware of law enforcement’s institutional bias. I still make the case that the legal staff has been ignorant of the law. There’s been no apology to-date for this, and for the inappropriate targeting of doctors for having recommended medical cannabis. I and other doctors still do not feel safe from further harassment, nor do other doctors in California.
Let’s see… I actually want to… and I’m going to commend the working group on medical cannabis. I like the document, a lot of the document. The main… I’m going to look over it sentence by sentence and come up with more comments. But one of the…
MAN: I’m going to ask to submit those to this Board in writing.
Dr. Lucido: I will submit them. But one important thing is when you’re talking… if you mention prescription drug, you need to say ‘prescription or non-prescription drugs.’ The point I want to make is this is the Physician’s Desk Reference for non-prescription drugs and now they’ve added dietary supplements to it. But the pharmaceutical drugs in here, non-prescription, almost every one of them has caused deaths. So if you’re going to add prescription drugs, you’ve got to say prescription or non-prescription drugs, because doctors have whatever responsibility they have. So you’ve got to hold… whatever standards you’ve made for medical marijuana you have to make that for any therapeutic intervention. So I’m glad it does say, ‘therapeutic intervention.’ If you’re going to say prescription drugs, you’ve got to add ‘or non-prescription drugs.’
And just two more… a couple more comments. I was a little bit troubled to see the working group included this morning at breakfast, included Larry Mercer and Jane Zack Simon. They are PROSECUTING attorneys of the District Attorney’s office. And I’m a little dismayed that they would be on it because I think, again, law enforcement’s institutional bias has been showing throughout in the investigation of doctors.
Also, a little bit concerned, as I mentioned the time before that, that Mr. Thornton is back, when he had made the mischaracterization a year ago of "all of these doctors are just having a cash register, charging $200, no medical equipment." The mischaracterization was as if that was ALL doctors. He pointed to one outlier, and that’s a misinterpretation. When he wasn’t there for the next meeting, I assumed he had been fired. So then at the November, the November meeting when I hear he’s a consultant, I was dismayed. I mentioned that in the January meeting. And now I hear he’s back as… Anyway, I don’t want to [...unintelligible...] him, but…
MAN: Keep it to the [...unintelligible...] medical marijuana…
Dr. Lucido …I’m just a little bit concerned about how you get your staff. This brings up the question I’ve been wondering about and would like to know if you have an answer for me. I’m very concerned about how they come to be your legal staff, HOW do you chose them, DO you chose them, are they CHOSEN FOR YOU? By WHOM? By WHAT criteria or by what process? Who chooses WHAT is investigated? Who audits them, and how often?
That’s all I need to say about that. I just want those questions to be there. But, again, I want to commend the working group. I like most of this and I will give you comments in writing for further…
Two other things I’m going to just give you that you could pass out, just a… one salient page of two paragraphs from Conant v. Walters. I gave you the entire thing last time, but I want to make sure you have that. And I have transcripts of 50 minutes of last time’s meeting. So I want you to have the transcripts of the salient 50 minutes, and you might want to see how much of that actually ended up in the minutes. And are the minutes available for us too, in the public? The minutes of last time’s meeting?
Dr. Lucido: Great. I would like a copy of that.
Dr. Lucido: Great. Thank you. That’s my comments.
MAN: R. Stephen Ellis, M.D.?
R. STEPHEN ELLIS: No thank you. But I would like to thank you guys all for all the work that everyone’s doing.
MAN: Dennis Peron?
MAN: He stepped out just for a moment, I believe.
MAN: John Entwhistle? Okay, this looks like P. Denny?
DR. DENNY: Yes. Good morning. Thank you for allowing me a moment to speak. My name is Dr. Denny. I’ve been involved with medical cannabis evaluation practice, first in Sacramento, now here in Orange County for the last 4 years. Just a couple of brief comments.
First of all, I would just make a brief comment that what we’re talking about should be called ‘cannabis’ and not ‘marijuana.’ Marijuana’s a Mexican slang word. And I think we should use proper terminology in this professional context. And I would ask for that.
Secondly, it’s clear that the government has lied to us about the risk of cannabis for over the last 60 years. The fact of the matter is with any cursory evaluation of the literature, it will become clear that cannabis is less harmful and risky than even aspirin. And this is all documented. If you look at a term called the therapeutic Index, which we physicians use to determine the potential risk of medication we can see that use of cannabis in the Therapeutic Index is almost infinity. That means it’s very low risk, even in large amounts.
I would point out that in California there are now approximately 3 million users of cannabis. Now, of course, these are not all medical users but there are 3 million people who use cannabis. This points out the ubiquitous nature of this substance. And I would ask the question, with 3 million users, where’s the harm? It’s hard to see it in any casual look. This suggests that these people who use cannabis, if they use even a minimal amount, about 7,000 pounds of cannabis is consumed in California every day. So just to put that in perspective.
In comments about the document that was produced today, I also commend the staff for producing this. It’s a long time coming. And very welcome. My comment is, is that cannabis is not a prescription. I would prefer that it were. And were it a prescription, I would be happy to follow the same standards as any other prescription. But the fact is it is not a prescription. And I feel that we should not be held to the same standards until, and if, it becomes a prescription. It is not possible to prescribe this substance, as much I would like to.
I would finish my comments with just a brief comment about how I see my role as a physician here. And that is, is that I’m a specialty consultant about this issue and not a primary care physician. It would be hoped that each patient would have a primary care physician, but as we know in the real world that is not always the case. I would object to being held to the same standards as a primary care physician, because that is clearly not the service that I offer. And I would ask that the Board consider that in looking at this whole issue.
MAN: ANDREW [...Unintelligible...]?
MAN: Yes, sir. Ladies and gentlemen of the Board, thank you very much for all your time. And I know this is ongoing for, oh, since the last century, which I’ll bring up in a moment.
But I’m… I’d like to implore the Board to distribute a bulletin to… I believe the proper would be… I’ll… this microphone. To distribute a bulletin to law enforcement, preferably the Attorney General’s Office, in respect to all of California’s 58 counties, to notify them that the medical cannabis issue became law last century, almost eight years ago, and law enforcement in our 58 counties, hundreds of cities, are still having difficulty accepting this law. Even the latest SB420, signed by Governor Davis before leaving office, before the Governator here came in, pertaining to guidelines, law enforcement is still unclear and in the dark, and ignorance is no excuse for not knowing the law. Right here in Orange County, the 39 cities all have different policies, ranging from confiscating the patient’s medical cannabis and their documents, the recommendation from their physician, as well as putting the patient through four pre-trials in one city, whereas the neighboring city will… the police officer will honor it. They’ll be questioned by a couple of different officers on what their medical condition is, if they stand with their right, their patient’s right, the officer does return their medicine and their document. And that’s one city to the next, neighboring cities, Irvine and Mission Viejo, which are the two neighboring cities of the city we’re in right now. And that’s just an example. But here we have 39 cities. Every city takes it differently—okay?—because every law enforcement narcotics officer handles this differently. I think, I really feel a bulletin needs to be put out and maybe you can encourage the Attorney General’s Office to do so.
But I’d also like to say is that… maybe a copy of the Action Report that is going to be published with the amended, hopefully, motion that’s on the table now, once it’s seconded and put through, if it is put in your Action Report, maybe a copy of that Action Report can be forwarded to the Attorney General’s Office, to Mr. Lockyer… the General, Lockyer. And all police chiefs and narcotics officers in all California cities, not just counties, but go for the cities. Yes, there is an expense, but, you know, I think we can even raise the funds if there’s an expense that you don’t want to put forth. I’m not asking for anybody on this Board or law enforcement to vote in any elections to make law here in California. I’m just asking for you to enforce it. Again, I implore all of you on this Board to please put these different agencies on notice, starting with the Attorney General’s Office. Thousands of sick, disabled, and dying patients are still being harassed right here in our wonderful golden state of California. It really needs to cease.
And I want to thank the Board again. Thanks for your time.
MAN: Fred Gardner?
FRED GARDNER: Good morning. I’m the editor of a paper called O’Shaughnessy’s, named in honor of the physician who introduced cannabis to Western medicine in 1839. It’s produced on behalf of a small but growing group of physicians who are interested in the clinical applications of cannabis, and I would like to give you a copy… give each of you a copy this morning. And in my comments on the work of the Task Force will be in the next issue. Thank you very much.
MAN: William Britt?
WILLIAM BRITT: Yes. I’m William Britt. I’m the Director of Association of Patient Advocates. And, first I’d like to thank you for addressing this issue. And I attended in 1997 when [...unintelligible...] decided to just take it on a case-by-case and it seems like it’s been awhile, almost seven years since… to get to this state. I just hope that the guidelines will move forward a little faster now that we have some relief from the federal government and from the state, and with the Mower decision. The only thing that disturbs me, though, is that there’s no patients’ represented on the Task Force. And I believe in the future to really be fair, that there should be patients or their representatives represented on the Task Force, and establish an input on it.
That’s about it. Just, once again, thank you for working so hard and getting moving forward on this and I hope you move forward a little faster. Thank you.
Wender: Is… I’ve gone through the sign-up sheet. Is there anybody else?
MAN: Dennis Peron had wanted to [...unintelligible...].
DENNIS PERON: Thank you for your [...unintelligible...]. I [...unintelligible...] Proposition 215, having written it, and I’ve taken a little responsibility for what is happening here today, and… and I’d like to thank you for the guidelines. I don’t agree with them. [...Unintelligible...]
MAN: Excuse me. They’re going crazy over there. They need your name for the record.
Peron: Oh, excuse me. My name is Dennis Peron. I’m the author of Proposition 215. And I know when I wrote this law that I would stir up a hornet’s nest because here is a conflict with the federal and the state. People voted for this, and they wanted to see it happen. I was hope… hopefully the federal government will come around. I know they will. It will take time. I didn’t know it would take this much time, but, it did. And I thank you for the guidelines, because doctors really didn’t know what to do. And it’s a new field and I know we’ve had a little conflict going on. I wrote it for my lover who had AIDS. He is not with us any longer.
And on the recommendation of number seven, it said to periodically review the patient. Well, that may be very good, but, see, AIDS does not go away. And for Jonathan, my lover, to go to see a doctor every six months or every year, would have been inconvenient, not to mention it would have been a little expensive. And Jonathan used marijuana for anorexia, for… he used it also for depression. And the AIDS didn’t go away, the depression didn’t go away, the anorexia didn’t go away. He could have gone to a doctor every six months to say, ‘Doctor, I still have these things.’ It would have been a little inconvenient. So number 7 that say they have to review every six months, even Mr.Britt, that just came before us obviously has cerebral palsy. Cerebral palsy is not going away. If they’re going to keep going back to a doctor every six months seems a little redundant, not to mention it is expensive. Doctors are expensive and they take time out and the physician had to take time out.
And I would like to thank Alice Meade for giving me guidance when I was writing the drafting Proposition 215. She gave me a lot of guidance in how to word it and how to present it to the people. And today she’s still with us, and I appreciate her work.
And I also appreciate Larry Mercer and Jane Simon, who are [...unintelligible...] for eight years too. And I appreciate their help and their guidance. Even though that they were the initial prosecutors of myself, I developed a rapport with them. And I agree with them, that marijuana is a drug, that I’d put it under doctor’s supervision because I didn’t want people to go to jail. I trust the doctors more than I trust lawyers or even the police.
And if we think that what is Proposition 215, what does it do, it protects a patients from going to jail. They’re using marijuana to alleviate a certain thing that helps them. Should they go to jail? And I thought it was wrong. And I think you would agree with me that jail is not good for a patient. And I put recommend or approve, what are we recommending or approving? We’re approving that a patient should not go to jail for a medicine that they think is helping them. And a lot of people say, ‘Well, they think that they’re getting better, but they’re not.’ I don’t separate the mind and the body. And Eastern medicine considers mind and the body as one. If you think you are feeling better, you are feeling better. And marijuana makes you feel better.
And I would like to thank you for doing all that you’ve done here, and these recommendations. I have no problem with them, except number 7, to constantly review the use of marijuana. I think that could be done with a phone call without having the patient go in to see the doctor. And… well, I’d just to thank that we’ve come this far, and know that we still have further to go and have conflicts.
I have a short story with Conant. Marcus Conant is a good friend of mine. He’s a doctor. He’s a dermatologist. And it was on the stand… he was prosecuted for his recommendation of marijuana. At one point, the prosecutor said, ‘Did your recommendation allow a patient to get marijuana? Did you tell that patient to go through Cannabis Club to get marijuana?’ Marcus’ lawyer says, ‘Oh, I would like a time out.’ He went out in the hallway and said, ‘Marcus , if you say yes, the prosecutor is going to arrest you and charge you with furnishing marijuana with the… as prosecutor.’ Marcus went on the stand and said, ‘Yes. I recommended it. I’m totally [...unintelligible...].’ Subsequently, Marcus was arrested right after the trial and charged with furnishing marijuana.
It was that decision, the Alsup decision which was really… originally furnished that… put that on hold, that said "no, you cannot prosecute Marcus Conant" despite the fact that he did recommend marijuana, and he did that person where to get it. And so that is the decision that is on… it is the law of the land. So Marcus Conant, a very brave man stood up to the beasts and was exonerated. And that is the law of the land now and right now we have a federal court that says you can, indeed, grow your own marijuana as long as it’s intrastate and you do not sell it. And that will be challenged by the Supreme Court. As we all know on May 21st, the case is set to begin. For this moment in time, there is no conflict with federal and there is no conflict with… with Proposition 215 on a federal or a state level. So for this window, this one moment in time, there is no conflict that what we are doing here is correct.
I thank you very much for your indulgence.
MAN: Hearing no further comments, with a motion on the floor that's
been seconded. All in favor? All opposed. Passed.
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