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0468
1 UNITED STATES DEPARTMENT OF JUSTICE
2 DRUG ENFORCEMENT ADMINISTRATION
3
- - - - - - - - - - - - - - - x
4 :
In the Matter of: :
5 : Docket No. 05-16
LYLE E. CRAKER, Ph.D. :
6 :
- - - - - - - - - - - - - - - x
7
8 VOLUME III
9
Wednesday, August 24, 2005
10
DEA Headquarters
11 600 Army Navy Drive
12 Hearing Room E-2103
13 Arlington, Virginia
14
15 The hearing in the above-entitled matter
16
17 reconvened, pursuant to adjournment, at 9:05 a.m.
18
19 BEFORE:
20
21 MARY ELLEN BITTNER
22 Chief Administrative Law Judge
0469
1 APPEARANCES:
2 On Behalf of the DEA:
3 BRIAN BAYLY, ESQ.
Office of Chief Counsel
4 Drug Enforcement Administration
Washington, D.C. 20537
5
IMELDA L. PAREDES, ESQ.
6 Senior Attorney
Office of Chief Counsel
7 (202) 353-9676
8 CHARLES E. TRANT, ESQ.
Associate Chief Counsel
9 Office of Chief Counsel
(202) 307-8010
10
On Behalf of the Respondent:
11
JULIE M. CARPENTER, ESQ.
12 Jenner & Block LLP
601 13th Street, N.W.
13 Suite 1200 South
Washington, D.C. 20005
14 (202) 661-4810
15 M. ALLEN HOPPER, ESQ.
Senior Staff Attorney
16 Drug Reform Project
American Civil Liberties Union Foundation
17 1101 Pacific Avenue, Suite 333
Santa Cruz, California 95060
18 (831) 471-9000 Ext. 14
19 ALSO PRESENT:
20 MATTHEW STRAIT
Representative of the Government
21
Richard Doblin, Ph.D.
22 Representative of Respondent
0470
1 C O N T E N T S
2 WITNESS DIRECT CROSS REDIRECT RECROSS
3 Richard Doblin 471 614 731 742
Voir Dire 592
4
- - -
5
E X H I B I T S
6
EXHIBIT NOS. MARKED RECEIVED
7
RESPONDENT'S
8
12 576 withheld
9
13 542 542
10
14 542 542
11
15 507 507
12
19 559 559
13
26 598 withheld
14
28 - 33 520 520
15
52A and B 546 546
16
GOVERNMENT'S:
17
18 54 588 588
19
20 30B 747 747
21
22 - - -
0471
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. Ms.
3 Carpenter.
4 MS. CARPENTER: Good morning, Your Honor.
5 We'd like to call Dr. Richard Doblin.
6 JUDGE BITTNER: Okay. Dr. Doblin, you
7 know the drill, I think.
8 DR. DOBLIN: I do.
9 Whereupon,
10 RICHARD DOBLIN, PH.D.
11 was called as a witness herein and, having been
12 first duly sworn by the Administrative Law Judge,
13 was examined and testified as follows:
14 JUDGE BITTNER: Please be seated.
15 DIRECT EXAMINATION
16 BY MS. CARPENTER:
17 Q Good morning, Dr. Doblin.
18 A Good morning.
19 Q Could you state and spell your name for
20 the record?
21 A Richard Doblin, D-O-B-L-I-N.
22 Q And what's--
0472
1 A And I live at 3 Francis Street, Belmont,
2 Massachusetts 02478.
3 Q Dr. Doblin, what's your job?
4 A I'm the President of the Multidisciplinary
5 Association for Psychedelic Studies.
6 Q Okay. And before we get to that further,
7 let's talk a little bit about your education. What
8 degrees do you hold?
9 A I have a bachelor's in psychology from New
10 College of Florida.
11 Q Okay.
12 A I have a master's in Public Policy from
13 the Kennedy School of Government, and a Ph.D. in
14 Public Policy also from the Kennedy School.
15 Q All right. And what did you do your
16 master's work in?
17 A The master's was, well, I did my thesis, a
18 survey of oncologists asking them to compare
19 Marinol, the oral THC capsule, with smoked
20 marijuana, and wanted to know what experience they
21 had, what they thought about the two different
22 substances.
0473
1 Q Okay. And I'm sorry, you got your Ph.D.
2 where?
3 A Also at the Kennedy School of Government.
4 Q Is it Harvard?
5 A At Harvard, yes.
6 Q And what did you do for your Ph.D. work?
7 A My dissertation was a study of the
8 regulation of the medical use of Schedule I drugs.
9 Q And when did you receive your Ph.D.?
10 A 2001.
11 Q Okay. So getting back to the
12 Multidisciplinary--tell me again--Multidisciplinary
13 Association for Psychedelic Studies?
14 A Yes.
15 Q Okay. And when was that founded?
16 A I founded that in 1986.
17 Q And can you explain what that is?
18 A It's a nonprofit research and educational
19 organization whose mission is to develop Schedule 1
20 drugs into FDA approved prescription medicines and
21 to educate the public honestly about the risks and
22 benefits. In a sense, it's a nonprofit
0474
1 pharmaceutical company.
2 Q Okay. And what do you mean by--why
3 psychedelic? What does that mean?
4 A Psychedelic is a word that was invented in
5 the 1950s by a fellow named Humphrey Osmond, and it
6 means mind-manifesting, and it doesn't specifically
7 refer to drugs. It can be dreams, for example, are
8 mind manifesting. Meditation is mind manifesting.
9 So it's distinguished from like psychotropic
10 medications which means to move the mind. So
11 antidepressants, stimulants, things like that move
12 the mind, but they don't necessarily in a sense
13 manifest or reveal the unconscious.
14 So it's about tools and procedures that
15 bring to the surface people's subconscious and
16 unconscious and, you know, deeper emotions.
17 Q Okay. And what would be the medical
18 purposes of such drugs or practices?
19 A Well, one of the more interesting ones I
20 think is in the treatment of addiction. So, for
21 example, there was in the '50s and '60s, there was
22 a lot of research with LSD for the treatment of
0475
1 alcoholism. Bill W., who founded AA, actually
2 describes an LSD experience that he had in the book
3 Pass It On, which is the official AA book about how
4 he felt that LSD helps.
5 One of the classic features of addiction
6 is denial, and people suppress a lot of emotions.
7 And so under the influence of psychedelics, you can
8 help people realize the consequences of what
9 they're doing to themselves and others, and then
10 there has also been kind of thousands of years of
11 historical use of these substances in religious
12 context.
13 And so when people have the opportunity to
14 get past the denial, sometimes they feel more
15 connected to a certain spirituality and a certain
16 life and that also can be helpful in the treatment
17 of addiction.
18 There's other benefits, in a sense,
19 generically to enhance psychotherapy. So, for
20 example, we have a study with MDMA, which is
21 otherwise known as Ecstasy. And we have FDA
22 approval for a study there in the treatment of
0476
1 post-traumatic stress disorder.
2 Q Okay. We'll talk a little bit more about
3 that later, but let's just first get a little more
4 information about MAPS. How is it composed?
5 A MAPS is a membership organization. We
6 have about 1,500 members. We have a small board of
7 directors, and--
8 Q And who tend to be the members?
9 A Well, we have a range of members. We have
10 a fair amount of doctors and psychologists and
11 psychotherapists who are interested in the
12 development of these tools that they might
13 eventually use in their professions.
14 We have a fair amount of people who are in
15 one way or another supportive of scientific
16 research in this area, but who wouldn't necessarily
17 use it in their professions. We have a fair number
18 of students. We have about 200 of the members are
19 from around the world. Most are centered in the
20 United States, but a lot of them are in other
21 countries as well.
22 Q Okay.
0477
1 JUDGE BITTNER: Is MAPS a 501(c)(3)?
2 THE WITNESS: Yes, it is.
3 BY MS. CARPENTER:
4 Q And where do you get your funding?
5 A From the members. In a sense, there's
6 what we call market failure because these
7 particular drugs, most of them are off patent, so
8 pharmaceutical companies aren't interested in
9 funding. Government, like the National Institute
10 of Mental Health, these are too controversial for
11 at least support from those organizations.
12 So what we need to do is rely on private
13 donations. We have a fair amount, as with most
14 nonprofits, you know, roughly, you know, ten or 15
15 percent of the money comes from 90 or 95 percent of
16 the members, and then you have a small group of
17 donors that give larger amounts.
18 Those include family foundations. We have
19 a fair amount of people who made a lot of money in
20 the technology business who have then donated
21 money.
22 Q And then what would you say is MAPS'
0478
1 mission? Do you have a mission statement?
2 A Yeah, the mission statement is to develop
3 psychedelics and marijuana into FDA-approved
4 medicines and then to educate the public about
5 that.
6 Q Okay. You said MAPS sponsors research.
7 What kind of research has MAPS sponsored or done
8 along these lines?
9 A Well--
10 Q With what particular substances, I guess I
11 would say?
12 A There's a study that we sponsored in
13 Russia with Ketamine in the treatment of alcoholics
14 and Ketamine in the treatment of heroin addicts.
15 For awhile, that was the only psychedelic
16 psychotherapy study in the world. We've funded
17 research with MDMA. We've funded research--
18 Q Okay. Let's just stop right there. Can
19 you tell me what MDMA is?
20 A MDMA is methylenedioxymethamphetamine. I
21 don't want to spell it. It was invented in 1912,
22 patented by Merck Pharmaceutical in 1914. Looks
0479
1 like it was never, never used by them, and it was
2 then used in the 1950s by the Army Chemical Warfare
3 Service looking for mind-control drugs, and then it
4 was explored by psychotherapists in the middle '70s
5 and then it unfortunately escaped from the
6 therapeutic context and became known as Ecstasy,
7 and then was scheduled by the DEA in 1985.
8 Q Okay. So prior to its scheduling in 1985,
9 it was used by psychotherapists; did you say?
10 A Yeah. Actually--
11 Q What for?
12 A Its use really was pioneered by
13 psychotherapists and psychiatrists and it was used
14 for a whole range of purposes, working with the
15 terminally ill, helping them deal with the anxiety
16 of facing death, working with post-traumatic stress
17 disorder, couples therapy, working with people for
18 personal growth.
19 Q Okay. And what does it do?
20 A It's unique. When you, classically when
21 you think about the word "psychedelic," people
22 think visuals and colors and your mind is, you
0480
1 know, operating in a different way, but MDMA is a
2 different kind of psychedelic in that it deepens
3 people's access to their emotions. It gives a
4 sense of self-acceptance and helps people to deal
5 with difficult emotions, but its use, I would say,
6 is dependent a lot on the context, as with all of
7 these drugs, you know, so that it's also useful in--people
8 have found it to be useful in, you know,
9 energy. It keeps you awake and so that's where
10 it's found its use in the recreational purposes as
11 well.
12 MS. CARPENTER: Okay.
13 JUDGE BITTNER: And what schedule is it in
14 now?
15 THE WITNESS: Schedule I.
16 BY MS. CARPENTER:
17 Q And does it have risks?
18 A Oh, yes.
19 MR. BAYLY: Your Honor, excuse me.
20 Objection here. I'm not sure. I don't believe
21 this is in the prehearing statement, but even if it
22 is, we're getting off target, off base here. We're
0481
1 getting into a lot of detail of MDMA.
2 I understand that it may be helpful to
3 have a little bit of background, but we're going
4 much further than is necessary.
5 MS. CARPENTER: Your Honor--
6 MR. BAYLY: So the two objections are it's
7 not in the prehearing statement and even if it is,
8 we're really getting far afield of the relevancy
9 here.
10 MS. CARPENTER: Your Honor, on page, the
11 proposed testimony of Rick Doblin.
12 JUDGE BITTNER: Uh-huh.
13 MS. CARPENTER: The second paragraph.
14 MAPS promotes scientific research into the risks
15 and benefits of Schedule I substances in treating
16 various medical and psychological conditions. MAPS
17 provides financial, regulatory and scientific
18 assistance to researchers who MAPS helps to design,
19 fund and obtain necessary approvals to conduct
20 their studies.
21 JUDGE BITTNER: Okay. I'm sorry. I can't
22 find it. Oh, okay.
0482
1 MS. CARPENTER: It's second paragraph.
2 It's on the second page.
3 JUDGE BITTNER: Okay. At the top of a
4 page. Okay.
5 MS. CARPENTER: Top of the--right, right,
6 sorry about that. And then in the next paragraph.
7 JUDGE BITTNER: I'll overrule the
8 objection, but I don't want to go real far with it.
9 MS. CARPENTER: I understand. And I
10 guess--
11 BY MS. CARPENTER:
12 Q Are you currently sponsoring research
13 involving MDMA?
14 A Yes. MAPS opened a drug master file for
15 MDMA, 1986.
16 Q Okay.
17 A And we helped sponsor the first study in
18 humans, the first Phase 1 safety study in 1992 and
19 currently we have a project in Charleston, South
20 Carolina which is MDMA for the treatment of post-traumatic
21 stress disorder. And that's halfway
22 completed. We're getting very good results from
0483
1 that.
2 We also have FDA and Institutional Review
3 Board approval for a study at Harvard Medical
4 School with MDMA for advanced cancer patients with
5 12 months or less to live with anxiety, and we're
6 still waiting for DEA approval for that study, but
7 we anticipate hopefully that will come in the next
8 month or so.
9 Q Okay.
10 A We're also working internationally and we
11 have a study for survivors of war and terrorism-related
12 incidents with post-traumatic stress
13 disorder in Israel, and we're working with the
14 Ministry of Health there.
15 We are working in Switzerland with a group
16 of researchers and an ethics committee now also for
17 MDMA for post-traumatic stress disorder.
18 We have a study in Spain that's working
19 through the approval process as well.
20 Q Okay.
21 JUDGE BITTNER: Excuse me, though, Dr.
22 Doblin, Ketamine is not a Schedule I?
0484
1 THE WITNESS: No, Ketamine is not. But
2 it's--
3 JUDGE BITTNER: Okay. So you're not
4 limited to Schedule I.
5 THE WITNESS: Right, right.
6 JUDGE BITTNER: Okay.
7 BY MS. CARPENTER:
8 Q And just all the research that you talk
9 about in the United States, that's all approved by
10 the FDA?
11 A Yes, yes.
12 Q And all the DEA licenses that are
13 necessary have been obtained?
14 A For all the ongoing studies, yes. I mean
15 we're still waiting for DEA for the Harvard cancer
16 patient study.
17 Q Waiting for some, but the ones that are
18 ongoing. Okay. And again, you said you had the
19 master file on that, and we heard some testimony
20 about that yesterday, but MAPS hold that itself?
21 A Yes.
22 Q And how does that happen?
0485
1 A Well, whenever you want to do research
2 with the drug, the FDA wants to know what is that
3 drug, and so we contracted with a private
4 manufacturer, a DEA licensed manufacturer, to
5 product the MDMA, and then the FDA wanted to know
6 all of the steps in the synthesis, how it was kept,
7 and that information went in the drug master file,
8 and then periodically the FDA wants to know the
9 stability of the drug.
10 So we've had to have repeated analysis to
11 see how the purity over time of this particular
12 drug. So that also goes into the drug master file,
13 and then we conducted 28-day toxicity studies in
14 the dog and the rat and submitted that into the
15 drug master file as well.
16 Q Okay. And so MAPS didn't get this MDMA
17 from NIDA?
18 A No.
19 Q Okay.
20 A No, not at all.
21 Q You got it from a private company?
22 A Well, not a company, but a manufacturer,
0486
1 researcher who had a DEA license to produce the
2 MDMA.
3 Q Are there more than one of these
4 companies?
5 A Yes, there's quite a few. There's quite a
6 few. So that we would have had several different
7 options to negotiate with various people to get the
8 MDMA made for us.
9 Q Okay. Have you also done some work with
10 psilocybin?
11 A Yes, we have. We have a study at the
12 University of Arizona Tucson.
13 Q Let me just ask first, what is psilocybin?
14 A Oh, okay. Psilocybin is the active
15 ingredient in psychedelic mushrooms.
16 Q And is that a scheduled substance?
17 A Yes, it is. It's a Schedule I.
18 Q Okay. And what does it do in terms of
19 medical benefits?
20 A It's more--well, in terms of medical
21 benefits, again, it enhances the general preface of
22 psychotherapy. In our particular use that we have
0487
1 the ongoing study for, it's for the treatment of
2 obsessive-compulsive disorder.
3 Q And--I'm sorry--you said you had a study
4 for that going on now?
5 A Yes, yes.
6 Q Where is that?
7 A That was at University of Arizona Tucson.
8 That study, once we got it approved, once we had
9 all the approvals, we actually applied to NIDA and
10 NIMH for a supply of the psilocybin. We needed
11 just about half a gram, which is not very much, and
12 they had in stock, and we waited for a year, and
13 tried for a year, and was unable to purchase the
14 psilocybin from either NIDA or the National
15 Institutes of Mental Health, and so we were able
16 then to go find a private producer of psilocybin
17 that we contracted with.
18 We have the world's most expensive
19 psilocybin. It was $12,250 for one gram, but we
20 felt that whatever price we had to pay would be
21 worth it to get the study started, and so because
22 we had those options, now that study is underway
0488
1 and we're getting good results from that study as
2 well.
3 Q And again, were those studies approved by
4 the FDA before you tried to obtain the psilocybin
5 from NIDA?
6 A Yes, yes.
7 Q And had anybody else approved those
8 studies as well?
9 A Well, every study has, in humans has to be
10 approved by an institutional review board that
11 looks at the safety for the human subjects, and so
12 there was an institutional review boar at the
13 University of Arizona Tucson that had also approved
14 that study.
15 Q Okay. And again, you said there was a
16 private organization that had a DEA license to
17 manufacture those other--is there one? Are there
18 several?
19 A There's quite a few. There's quite a few.
20 Yeah.
21 Q Are there other--and we'll just go through
22 these briefly, but are there other substances that
0489
1 you are conducing research on that are Schedule I
2 substances, FDA approved research?
3 A At this point, we've had--no, those are
4 the only ones currently. We've had studies with
5 Ibogaine that we've helped support in the treatment
6 of heroin addiction.
7 Q And what is Ibogaine?
8 A Ibogaine is a root from Western Africa.
9 Q And what does it do?
10 A It seems to really reduce the withdrawal
11 symptoms and also it promotes this potential
12 psychological opening. And it seems to reduce
13 craving as well. We funded early pilot data and
14 that pilot data was then submitted to NIDA for a
15 larger grant which NIDA refused to provide.
16 Q Is that used in other places?
17 A Ibogaine is legal in England, Canada,
18 Mexico, throughout Europe. United States is one of
19 the few countries that it's criminalized, Ibogaine,
20 even though there has been virtually no reports of
21 its abuse, and so there are clinics in various
22 places administering Ibogaine to patients, and what
0490
1 we felt is that the results are just really
2 anecdotal, and so while there are people who claim
3 to have been helped and I believe that they
4 actually have been helped with Ibogaine, the
5 question is what percentage, how many, and so in
6 Canada, we're going to be trying to do an outcome
7 study with Ibogaine clinic to see really if we can
8 put some science to how well it actually works.
9 Q Okay. And how did MAPS get interested in
10 medical marijuana research, what prompted the
11 interest?
12 A Well, it started really, I'd say, with my
13 survey of oncologists which I did in '89-90, and
14 that showed me that there was substantial support
15 in the medical community for the use of marijuana
16 for nausea control for cancer chemotherapy. But at
17 the time, there was no research ongoing with
18 marijuana for any medical purpose whatsoever, and I
19 felt that that would be an area that would be worth
20 exploring.
21 Q Now, you said there was interest in using
22 it but no research. What do you mean by that?
0491
1 A Well, again-
2 Q When you say--I'm sorry--let me just
3 clarify. When you say "marijuana," is there a
4 difference between than and something else that the
5 oncologists were using?
6 A Well, Marinol is the oral THC capsule and
7 that was a prescription medicine. There had been
8 research. It started actually in the early 1970s
9 about marijuana for nausea control for cancer
10 chemotherapy. And then in the late '70s and the
11 early '80s, a series of states sponsored research
12 into this area, so they were state-funded studies
13 with NIDA marijuana that was provided to them.
14 And some of those studies compared smoked
15 marijuana with the oral capsule, and several of
16 those studies showed that smoked marijuana worked
17 better than the oral capsule in some patients, and
18 what happened, though, was that the FDA approved
19 the oral capsule and then all research was shut
20 down into the smoked form of marijuana.
21 And so when I did the survey of
22 oncologists, and it showed that there were some
0492
1 oncologists who believed that marijuana was more
2 effective in a smoked form than in the oral THC
3 capsule, it seemed that that was something that--
4 JUDGE BITTNER: Let's go off the record.
5 [Off the record.]
6 JUDGE BITTNER: Back on the record.
7 BY MS. CARPENTER:
8 Q All right. So you did this survey and
9 that indicated that there was significant interest
10 in the medical community for more research into the
11 use of smoked marijuana and I felt that MAPS, what
12 we're trying to do, in a way, is establish the
13 principle that drugs of abuse may also have medical
14 uses and that their research should be permitted
15 and that medical benefits should be made available
16 if possible, and so that's why I felt working with
17 marijuana as well. Marijuana, in some senses you
18 could call psychedelic because it also does tend to
19 bring emotions to the surface, thoughts to the
20 surface, so it's more of a milder version of some
21 other psychedelics.
22 Q Okay. So how did MAPS go about helping to
0493
1 fund or sponsor that research?
2 A Well, most researchers in this area had
3 been demoralized and had felt that permission--once
4 the oral THC pill was approved and all research was
5 stopped with smoked marijuana even though smoked
6 marijuana had been shown to be more effective in
7 some patients, the researchers really had gotten
8 demoralized and nobody had been even trying to do
9 research anymore.
10 And so the first thing that I had to do
11 was to try to find researchers who would be
12 interested in applying to the FDA to do studies and
13 that then MAPS would offer assistance in terms of
14 working through the regulatory system in terms of
15 protocol design, in terms of funding, and so I
16 spent about a year or so trying to find researchers
17 willing to invest their time in this, and I
18 couldn't find anybody.
19 And then there was a report in the paper
20 about a woman in California who, she was called
21 "Brownie Mary." She made marijuana brownies for
22 AIDS patients to help them with appetite. And she
0494
1 was arrested at--while she was getting marijuana to
2 make into these brownies, and she worked at San
3 Francisco General Hospital at the AIDS ward.
4 And so I called doctors there, and I said
5 one of your volunteers has just been arrested.
6 Would you be interested in trying to do some
7 research to show whether she was doing something
8 that might actually have been helpful to these
9 patients? She probably thought that it was helpful
10 since, you know, she was permitted on the ward to
11 do this.
12 And so I spoke to a Dr. Donald Abrams and
13 he said that he would be interested in trying to do
14 research in this area, and so we started to
15 collaborate and it took--it's a whole long story
16 which we can get into in a minute.
17 Q Okay. So did you help design a study?
18 How did you and Dr. Abrams work together?
19 A We did. We did. Dr. Abrams is one of the
20 world's leading AIDS researchers. He's often
21 credited with, you know, really helping identify
22 the fact that there was a virus that caused HIV
0495
1 virus. So we worked for quite awhile on the
2 development of the protocol. MAPS gave a small
3 grant for the development of the protocol to his
4 team of researchers, and after about a year and a
5 half or so, they were able to get FDA permission,
6 as well as permission from about three or four
7 other organizations or agencies.
8 In California, they have what's called the
9 California Research Advisory Panel, and they are
10 similar in a sense to FDA. They have to review all
11 projects with Schedule I and Schedule II drugs in
12 California. It's the only state that has that.
13 So Donald had to get approval from the
14 California Research Advisory Panel and various
15 institutional review boards, and also he
16 coordinated AIDS research in the San Francisco Bay
17 area and had to get permission from the Community
18 Consortium's own review board.
19 Q And did he have to get permission from the
20 institution where the research would be done as
21 well?
22 A Yes, from the San Francisco--UC San
0496
1 Francisco. So it was quite an extensive process,
2 and because he has such a good reputation and they
3 were at the forefront of AIDS research and because
4 many, quite a few AIDS patients had discovered on
5 their own that marijuana was helpful for appetite,
6 for dealing with the nausea, for helping them with
7 AIDS wasting, he was able to get permission from
8 all the necessary authorities to do the study.
9 Q When you say "permission," do you mean
10 formal approval?
11 A Formal approval, yes. Yes, and then--
12 Q Okay. Including the FDA?
13 A Including the FDA.
14 Q Okay. So what did he do next or what did
15 you--
16 A The last step that he needed before he
17 could do the study was to apply to NIDA for a
18 supply for marijuana that we're offering to
19 purchase. So we're not asking for any government
20 resources. We're going to pay for the study
21 ourselves. And unfortunately, Dr. Alan Leshner,
22 who was head of NIDA at the time, sent him, first
0497
1 off, sat on his application for nine months doing
2 nothing while we were waiting to see if we could
3 get a supply while people were dying of AIDS and
4 AIDS wasting, and then sent him a brief one-page
5 letter saying that your study is rejected; we're
6 refusing to provide you the marijuana.
7 Q Okay. And what was Dr. Abrams' response?
8 A Dr. Abrams was, I would say, outraged.
9 Q Would you turn to Respondent's Exhibit No.
10 15?
11 A Yes, I see it. Do I see it? Yes.
12 MS. CARPENTER: Do you have that, Your
13 Honor?
14 JUDGE BITTNER: Go ahead. I've got it
15 somewhere.
16 MS. CARPENTER: Okay.
17 BY MS. CARPENTER:
18 Q Have you seen this letter before?
19 A Yes, I have.
20 Q Who is it from?
21 A It's from Dr. Donald Abrams.
22 Q And who is it to?
0498
1 A It's to Dr. Alan Leshner.
2 Q And what's the date?
3 A April 28, 1995.
4 Q Did you see this letter on or around that
5 date?
6 A Yes, I did.
7 Q Okay. And can you tell us what this
8 letter is?
9 A This is the response that Dr. Abrams sent
10 to Dr. Leshner upon receiving the one-page letter
11 saying that the study was rejected and would not be
12 receiving marijuana.
13 Q Okay. And can you just briefly tell us
14 what he's saying in this letter?
15 A What he's saying is that, well, if I could
16 read just one or two sentences. He's saying that
17 he was reviewed and approved by the Committee on
18 Human Research of UC San Francisco as well as by
19 his own scientific advisory committee, and the
20 Community Advisory Forum. It was approved pending
21 location of the source of the marijuana by the
22 California Research Advisory Panel, and the U.S.
0499
1 FDA had approved it.
2 And that the general clinical research
3 center at San Francisco General had agreed to
4 collaborate and that AIDS wasting a serious
5 disease, and that he responded specifically to all
6 of the comments that Dr. Leshner had made.
7 Q Okay.
8 A And then ended up basically saying that he
9 felt that Dr. Leshner should be ashamed of his
10 decision.
11 Q And do you recall just briefly what the
12 particular criticisms were of the protocol?
13 A One of the criticisms was that the study
14 was not large enough to generate convincing data,
15 and what Donald Abrams is saying is that you start
16 with pilot studies, that you don't start with large
17 studies, that the normal drug development process
18 doesn't work that way.
19 He said that--that was in a way his basic
20 comment. He talked about how Dr. Leshner had said
21 that there was no way to standardize the dose of
22 how much patients were taking, and he was saying
0500
1 that they had to address that issue. That patients
2 would return any unused marijuana and that they
3 would be able to assess what patients had actually
4 used. So--
5 Q Okay.
6 A Yeah.
7 Q That's fine. And again, were you seeking
8 NIDA--were you asking--I'm sorry--was Dr. Abrams
9 and MAPS asking NIDA to pay for this study or
10 simply to provide the marijuana?
11 A Simply to sell us the marijuana and then
12 we would pay for the study itself as well.
13 Q Okay. So after you and Dr. Abrams
14 received the rejection from NIDA that they would
15 not provide you with marijuana for this FDA
16 approved study, what happened next?
17 JUDGE BITTNER: Could I ask a question
18 about the exhibit first?
19 MS. CARPENTER: Sure.
20 JUDGE BITTNER: On page two, Dr. Doblin,
21 the second full paragraph toward the end it refers
22 to patients returning any unused marijuana, and
0501
1 then the last sentence of that paragraph, there's a
2 reference to intent to treat analysis.
3 THE WITNESS: Umm, umm, okay.
4 JUDGE BITTNER: What is that?
5 THE WITNESS: Well, what it means is that
6 is it's kind of hard to describe, but intent to
7 treat is where certain factors--you primarily look
8 at the outcomes, and that this was sort of looking
9 at mechanisms, in a sense. How much marijuana did
10 they use? Did they get a certain--did they use a
11 certain amount, and so that's sort of like a dose
12 response study, how much marijuana, or how much of
13 any drug actually is effective in certain patients.
14 But intent to treat is you're basically
15 saying this is our goal to help these people with
16 their food intake and their weight and we're just
17 primarily looking at that as the outcome, and if--so that's-
18 -
19 JUDGE BITTNER: So, and I don't mean to be
20 leading, is Dr. Abrams saying that at this point
21 anyway, the study doesn't care how much the people
22 actually use?
0502
1 THE WITNESS: Well, it cares, but it's not
2 the primary issue. It's really looking at their
3 weight and their nausea.
4 JUDGE BITTNER: Is there any quantity that
5 will make a difference and then go into what
6 quantity would make a difference later?
7 THE WITNESS: Yes, yes.
8 JUDGE BITTNER: Okay. Thank you. Go
9 ahead, Ms. Carpenter.
10 BY MS. CARPENTER:
11 Q So what were the next steps that MAPS and
12 Dr. Abrams took, if any?
13 A Well, there was a whole series of steps.
14 We also were trying to see if we could import
15 marijuana from the Netherlands. There was a
16 company there that had permission from the Dutch
17 government to produce marijuana, and so we tried to
18 work with them to see if we could get permission to
19 import.
20 But it turned into this classic Catch-22
21 where the DEA said that they wanted the Dutch
22 government to issue the export permit first and the
0503
1 Dutch government didn't want to anger the U.S.
2 government, and so the Dutch government was saying
3 we want the DEA to issue the import permit first,
4 and then it ended up where the DEA said that the
5 Dutch government hadn't fulfilled all of what they
6 felt were their obligations under the international
7 drug control treaties to establish this treaty, and
8 that therefore for them to issue this import permit
9 would imply that the Dutch government had complied.
10 The Dutch government said it would comply
11 if they got this import permit and so we were
12 unable to import it. We also tried to see if we
13 could use seized supplies from the state of
14 California, but the FDA really doesn't like
15 research being done with seized supplies. You
16 don't know about where all they're produced. You
17 don't know how you can replicate it with other
18 seized supplies. It would be different.
19 And then finally, the only other option
20 left was to try to see if we could contract with
21 Dr. ElSohly who produced marijuana for NIDA to see
22 if he would contract independently to MAPS. I
0504
1 figured that he had the secure facilities, he had
2 the licenses, that he might be interested in
3 producing for MAPS.
4 Q So at the time he had a contract with NIDA
5 and was producing marijuana for them?
6 A Yes, he was. He was the sole supplier to
7 NIDA.
8 Q Okay. So did you contract Dr. ElSohly?
9 A Yes, I did, and our initial contact went
10 quite well. He seemed to be open to the idea. He
11 said, of course, that he needed to check with NIDA
12 and DEA to see what they would consider about this
13 possibility, and he also talked about how he
14 developed the patented marijuana suppository, a THC
15 suppository that he felt that had some advantages
16 for people that were nauseous for cancer
17 chemotherapy. Sometimes taking a pill is difficult
18 and he thought that this suppository might be
19 helpful.
20 And so as a way to try to encourage him to
21 work with us, we said that we would be happy to
22 test the suppository as well. That we would be
0505
1 willing to add a group to our protocol design that
2 would receive the suppository and test it against
3 smoked marijuana and see comparative advantages.
4 And so we went, you know--
5 Q Okay. Let me just stop you right there
6 and ask you to turn, if you would, to Respondent's
7 Exhibit 28.
8 MR. BAYLY: Is that 28?
9 MS. CARPENTER: 28, yes, and--
10 THE WITNESS: Yes, I see it.
11 MS. CARPENTER: And let me just step back
12 real quickly for one minute. I think I forgot to
13 move in Exhibit 15 which was the copy of the letter
14 from Dr. Abrams to Dr. Leshner, and I would move
15 that into the record at this time.
16 JUDGE BITTNER: Mr. Bayly?
17 MR. BAYLY: It's just one question about
18 the signature on the letter.
19 MS. CARPENTER: Right.
20 MR. BAYLY: At least the copy I have,
21 there isn't one.
22 MS. CARPENTER: That's right.
0506
1 JUDGE BITTNER: Right. There's just a
2 little bracket with signed.
3 MS. CARPENTER: Right.
4 BY MS. CARPENTER:
5 Q Can you explain that?
6 A I can explain it, yeah. At the time that
7 I wrote this, I still am not in the habit of
8 photocopying all the letters that I send out.
9 Q No, no. Who wrote--this is Exhibit No. 15
10 which was written by Dr. Abrams.
11 A Oh, Dr. Donald Abrams. He sent me an
12 electronic version, and so I don't know that I have
13 a signed copy, but I'm sure that Dr. Leshner would
14 have one or the files.
15 JUDGE BITTNER: Who sent you the
16 electronic version?
17 THE WITNESS: Donald. Dr. Abrams. Sorry.
18 Yeah.
19 JUDGE BITTNER: And said this is my
20 letter?
21 THE WITNESS: Yes, yes. I mean.
22 JUDGE BITTNER: Mr. Bayly.
0507
1 MR. BAYLY: Well, since Dr. Abrams is
2 going to be here in September, we want to be sure.
3 He could certainly say I did sign it, but I'll
4 leave that up to the Court whether to admit it now
5 or if Dr. Abrams needs to verify that he indeed
6 signed this.
7 JUDGE BITTNER: Well, since hearsay is
8 admissible, and the witness says, and you were
9 fairly sure that the e-mail--I assume you got it by
10 e-mail?
11 THE WITNESS: Yeah, I'm sure.
12 JUDGE BITTNER: Yeah. Was from Dr.
13 Abrams?
14 THE WITNESS: Yes.
15 JUDGE BITTNER: Okay. In that event, I
16 will receive it, mainly so we don't have to think
17 about this in September.
18 MS. CARPENTER: Thank you, Your Honor.
19 One less thing on the list.
20 JUDGE BITTNER: Okay. Received.
21 [Respondent's Exhibit No. 15
22 was marked for identification
0508
1 and received in evidence.]
2 BY MS. CARPENTER:
3 Q So turning your attention to Exhibit 28,
4 have you seen that letter before?
5 A Yes, yes, I wrote it.
6 Q You wrote it. And what's the date on it?
7 A May 10, 1995.
8 Q And who is it addressed to?
9 A It's to Dr. ElSohly.
10 Q It doesn't have an address. Did you know--was
11 that sent to Dr. ElSohly?
12 A Oh, yes, yes.
13 Q Okay. Do you know how it was sent?
14 A I mailed it to him.
15 Q Okay. And the one that we have is not
16 signed. Why is that?
17 A Well, I wasn't in the habit of making
18 photocopies of letters that I sent out. I had the
19 electronic version which didn't have my signature,
20 so I printed out the electronic version for this
21 case.
22 Q Okay. But this is the letter that you
0509
1 sent?
2 A This is the letter that I sent, yeah.
3 Q Okay. And what's this letter about?
4 A Well, this is the sort of, I think I
5 initially contacted him by phone and then I
6 followed up with this letter saying basically that
7 we were working with--that MAPS was working with
8 Dr. Abrams and that we had a protocol that we were
9 seeking 1.8 kilograms of marijuana to conduct, and
10 that Dr. Leshner had refused to provide the
11 marijuana from NIDA and that we were wondering if I
12 spoke--it says I spoke to an official at the FDA
13 yesterday and he suggested that I resolve the
14 supply problem by directly contracting with you,
15 with Dr. ElSohly.
16 And so I asked him if he would be willing
17 to do this, and that we would do it with all the
18 necessary DEA approvals for the shipment if he
19 would agree to do it.
20 Q Okay. And again did this follow a phone
21 call or was this the first contact?
22 A I think I spoke to him briefly on the
0510
1 phone and then sent this letter to clarify.
2 Q Okay. And just to clarify one point.
3 Does it say in the first sentence there that it's a
4 5.4 kilograms?
5 A Oh, excuse me. Yes. That's right. It
6 was 1.8 kilograms of three different potencies.
7 Q Okay.
8 A I'm sorry.
9 Q All right. And then if you would turn to
10 Exhibit 29, Respondent's Exhibit 29?
11 A Okay.
12 Q Have you seen this document before?
13 A Yes.
14 Q Where is it from?
15 A This is a fax that I sent to Dr. ElSohly.
16 Q And what's the date on that?
17 A May 12, 1995, so two days after the
18 letter.
19 Q Okay. And did you send this--you did send
20 this to Dr. ElSohly?
21 A Yes, I did.
22 Q Okay. And what was the purpose of this
0511
1 fax?
2 A Well, I'm saying I faxed him the FDA
3 approved protocol for his review. He wanted to see
4 the protocol, and then we talk about the marijuana
5 suppository group that he was interested in adding,
6 and I indicate that we would explore that idea, but
7 I needed to talk it over with Dr. Abrams, and that
8 if we were to do that study, that we would ask him
9 to cover the costs of that particular group, since
10 it was a drug that he was trying to develop, but
11 that we would give him an opportunity to actually
12 get some data on his drug that he developed.
13 Estimated the costs per subject and then indicated
14 that, well, I conclude with a quote from Robert
15 Bonner, who ex-Administrator of the DEA, who said,
16 quote, "Those who insist that marijuana has medical
17 uses would serve society better by promoting or
18 sponsoring more legitimate scientific research
19 rather than throwing their time, money and rhetoric
20 into lobbying, public relations campaigns and
21 perennial litigation."
22 And I was saying that I totally agreed
0512
1 with Robert Bonner and felt that research was the
2 way to go, and that I hoped that Dr. ElSohly would
3 help us with that.
4 Q Okay. Did you have a conversation with
5 Dr. ElSohly between the time you sent the first
6 letter and this fax?
7 A Yes.
8 Q Does this fax indicate you did?
9 A Yeah. Yes, I did because that's where he
10 was interested in the protocol, actually seeing the
11 protocol.
12 Q Okay. And do you recall anything else
13 that you talked about during that conversation with
14 him?
15 A Well, just a bit about the suppository
16 group.
17 Q Okay. Did he seem willing at the time or
18 interested in going forward?
19 A He did. I mean he had never committed.
20 He was always saying he had to check it out with
21 his, with NIDA, with DEA, to see what they would
22 all think about it, with his university. But he
0513
1 seemed like he continually wanted to explore it
2 further.
3 Q Okay. And then if you would turn to
4 Respondent's Exhibit 30.
5 A Yes.
6 Q Have you seen this document before?
7 A Yes, I have.
8 Q And what is it?
9 A This is a letter, a fax actually to Dr.
10 Donald Abrams that I sent to him explaining some of
11 the conversations that I had with FDA about Dr.
12 Leshner's letter, and talking about how with Dr.
13 Gieringer that we had set in motion an attempt to
14 see if we could use seized supplies from the state
15 of California, and indicated also that there was a
16 Dr. Curtis Wright at FDA who had been the one that
17 suggested that I contact Dr. ElSohly to see if he
18 might contract with us directly.
19 And I mentioned here Dr. ElSohly has the
20 contract to grow marijuana for NIDA. He's
21 previously refused to analyze marijuana from the
22 buyers' clubs for its cannabinoid content out of
0514
1 fear of alienating DEA and NIDA.
2 Q And how did you know that?
3 A I'd heard that from the buyers' clubs.
4 Q Okay. So essentially you were just
5 telling Dr. Abrams your communications with Dr.
6 ElSohly there?
7 A Yeah. Basically this is just about what I
8 was doing to try to help secure a supply so Dr.
9 Abrams could move forward with his study.
10 Q Okay. And again this was the FDA approved
11 study that NIDA had refused to grant marijuana for?
12 A Yes, yes.
13 Q Could you turn to Exhibit 31?
14 A Okay.
15 Q And what's the date on this--well, first
16 of all, what is this document?
17 A This is another fax to Dr. Donald Abrams.
18 This is May 24, so it's about ten days or so after
19 the previous one. And what--
20 Q Is this a document that you wrote?
21 A Yes, it is.
22 Q Okay. And what was the purpose in terms
0515
1 of the issues that we've just been talking about
2 with Dr. ElSohly?
3 A This I was telling him that I had
4 approached, how I was being forced into this
5 perennial litigation. How I'd actually approached
6 Al Morrison from the Public Citizen Litigation
7 Group to see if they might be willing to help us
8 challenge NIDA's decision. And I also--
9 Q Yeah. Just want to point your attention
10 to paragraph three, the second sentence there.
11 A Okay. In the short run I'm still waiting
12 to hear from Dr. ElSohly, NIDA's supplier at the
13 University of Mississippi, about his willingness to
14 contract directly with MAPS to grow marijuana for
15 your study.
16 Q Okay. So does the indicate that at that
17 point, you still had--you had not heard from Dr.
18 ElSohly?
19 A Yes, that's correct. He was still
20 thinking it over.
21 Q Okay. And then if you turn to
22 Respondent's Exhibit 32. Have you seen this
0516
1 document before?
2 A Yes, I have. This is a fax that I sent to
3 Dr. ElSohly on May 25, 1995.
4 Q Okay. And what was the point of this fax?
5 A This I let Dr. ElSohly know that Dr.
6 Abrams and I had discussed the possibility of this
7 THC suppository group and adding that to the
8 protocol and that Dr. Abrams had indicated a
9 willingness to do that if Dr. ElSohly could fund
10 that portion of the study, and then I informed Dr.
11 ElSohly that we'd need to secure approval for the
12 new protocol design from FDA, UC San Francisco,
13 IRB, California Research Advisory Panel, and the
14 Scientific Advisory Committee of the San Francisco
15 Community Consortium..
16 Q Those are all the people who had
17 previously approved Dr. Abrams' study?
18 A Yes. And I also indicated to Dr. ElSohly
19 that Dr. Abrams had been contacted by a
20 pharmaceutical company several weeks before about
21 doing a study with the suppository and I was asking
22 Dr. ElSohly if those were connected, if that was
0517
1 actually a pharmaceutical company representing him.
2 Q Okay. And finally, if you would turn to--I'm
3 sorry--Respondent's Exhibit 33.
4 A Yes.
5 Q Have you seen that document before?
6 A Yes. This is a fax I sent to Dr. Lester
7 Grinspoon on June 1, 1995, and this was about, at
8 this point we were also exploring the idea of
9 importing marijuana from Switzerland and so I was
10 letting Dr. Grinspoon know that unfortunately the
11 people that I was working with in Switzerland said
12 that they didn't believe the Swiss Minister of
13 Health would stand up to the DEA and authorize the
14 export to the U.S., that that wasn't going to
15 happen, and that I was still waiting till hear from
16 ElSohly to see about his willingness to privately
17 contract with MAPS.
18 Q Okay. And that was dated June 1, 1995?
19 A Yes.
20 Q Okay. So as of that time, you had not
21 hear from ElSohly one way or the other?
22 A No, we were still waiting.
0518
1 Q Okay. At some point did you hear?
2 A Yes.
3 Q From Dr. ElSohly?
4 A Yes.
5 Q What did he say?
6 A Dr. ElSohly contacted me and said that he
7 decided that he didn't feel comfortable doing it,
8 that he'd gotten some sense from NIDA that they
9 would be uncomfortable if he did that, and so that
10 he was not going to help us out.
11 MS. CARPENTER: Okay. At this time, I
12 would move the admission of Exhibits 28 through 33.
13 JUDGE BITTNER: Mr. Bayly?
14 MR. BAYLY: No objection.
15 JUDGE BITTNER: Could I just ask--let me
16 see if I can remember which one--in 29, Dr. Doblin,
17 in the third paragraph, you refer to an open label
18 format. What's that?
19 THE WITNESS: What open label means is
20 that people know what they're getting. So that
21 it's not doubleblind. So that that would be an
22 open label. It would be hard for people to not be
0519
1 aware that, you know, when you get a suppository,
2 it's clearly a suppository, it's not smoked
3 marijuana. So that there would be an open label,
4 meaning that--
5 JUDGE BITTNER: So in a doubleblind--let's
6 see if I understand this--
7 THE WITNESS: Okay.
8 JUDGE BITTNER: --in a doubleblind,
9 neither the administerer nor the receiver knows
10 what's going from one to the other?
11 THE WITNESS: Yes. Yes.
12 JUDGE BITTNER: And in an open, everybody
13 does?
14 THE WITNESS: Yes, yes.
15 JUDGE BITTNER: And then is there also one
16 where the researcher knows and the--
17 THE WITNESS: Yes, there are singleblinds.
18 JUDGE BITTNER: And that's what a
19 singleblind is? Okay.
20 THE WITNESS: Yeah, and there's also
21 tripleblinds where--and that's the way we're doing
22 the MDMA post-traumatic stress disorder, and that's
0520
1 where the raters who do the outcome measures don't
2 know which group the people are in. So that's yet
3 another way to counteract bias where the people who
4 do the outcome measures have no idea which group
5 they're in.
6 JUDGE BITTNER: Thank you. With that,
7 Respondent's 28 through 33 are received.
8 [Respondent's Exhibits Nos. 28
9 through 33 were marked for
10 identification and received in
11 evidence.]
12 BY MS. CARPENTER:
13 Q Now, let me just ask you a couple
14 questions. During the discussion about Dr. ElSohly
15 and the letters that we just looked at, there was
16 some indications of suppositories.
17 A Yes.
18 Q Was it your understanding that Dr.
19 ElSohly was marketing those himself; was that his
20 own business?
21 A Well, he didn't market those. He had a
22 patent on that.
0521
1 Q Okay.
2 A And that he had developed it, and he was
3 obviously interested in trying to do the research
4 to see if he could get FDA permission to market it,
5 but at this point, I was not aware that he had
6 actually gotten any human data, that he'd never
7 used it in humans. And so that's where--or he may
8 have done some preliminary work in humans, looking
9 at what's called bioavailability, how much of it
10 gets into the bloodstream from this delivery
11 system, but I don't think he'd used it in patients
12 at this time.
13 Q Okay. And did you know at the time or do
14 you know now whether that was part of his contract
15 with NIDA or whether that was some independent
16 action that Dr. ElSohly was taking?
17 A I think that was independent and private
18 company that he had, that he was looking to develop
19 on his own for his own, you know, financial
20 purposes and scientific purposes. It was not under
21 contract to NIDA.
22 Q Okay. So was it your understanding that
0522
1 he was then able to use marijuana that was grown at
2 the facility in Mississippi for his own private
3 company's use?
4 A Well, actually I never really knew--I
5 thought that that was the case, but I never really
6 found out did he synthesize it or did he make it,
7 extract it from the marijuana.
8 Q I see.
9 A So I never pursued it to that depth
10 whether exactly he got the THC from.
11 Q Okay. So after NIDA had refused to
12 provide the marijuana at cost for the study and
13 after Dr. ElSohly had refused, what were the next
14 steps that you and Dr. Abrams took to pursue the
15 study?
16 A Well, we couldn't import. We could use
17 seized supplies. We couldn't grow it ourselves and
18 we couldn't purchase it from NIDA. We were
19 stopped. There was nothing we could do.
20 Q Okay. So the study just stopped?
21 A The study died.
22 Q Okay. What happened next?
0523
1 A Well, what happened next was Prop 215
2 which passed in California in 1996 and part of the
3 public debate about whether or not people should
4 vote for Prop 215 was the claim that the state
5 needed to act because the federal system of drug
6 review, the FDA system, was hopefully blocked by
7 virtue of NIDA refusing to supply marijuana to Dr.
8 Abrams and other researchers who were interested.
9 And so after Prop 215 passed, my
10 assumption was that NIDA realized and DEA realized
11 that completely blocking all medical marijuana
12 research was going to just continue to result in
13 more states passing medical marijuana initiatives.
14 So NIDA actually contacted Dr. Abrams and said that
15 now they would be interested in working with him if
16 he would completely redesign the study away from an
17 efficacy study looking at marijuana for AIDS
18 wasting and if he would look at marijuana and the
19 risks of marijuana in HIV positive patients.
20 Q And what did he say?
21 A Well, Dr. Abrams and I talked it over and
22 we felt that wherever we could start the research,
0524
1 at whatever point, that we should do that, that our
2 commitment should be to the patients, that even
3 though the study was not as we had hoped to do it,
4 that we should still go forward with the offer from
5 NIDA and NIDA actually offered a million dollars
6 for the study as well.
7 Q So they funded the study as well?
8 A NIDA funded the study, provided the
9 marijuana and what had happened also around this
10 time was that the protease inhibitors started just
11 early on coming into use, and so Donald was able to
12 figure out a way to design this as a safety study.
13 So he looked at the interaction of
14 marijuana with the protease inhibitors. And then
15 he also was going to look at viral load, immune
16 system functioning. There would still be some
17 information on caloric intake and weight gain, but
18 we were excluded from working with AIDS wasting
19 subjects. We had to specifically work with HIV
20 positive people who did not have AIDS wasting.
21 And so that's why it was primarily a
22 safety study, but Dr. Abrams worked with NIDA,
0525
1 redesigned the study and then submitted it to NIDA
2 for a grant, was able to receive the grant and the
3 marijuana and was able to conduct the study.
4 Q And what were the results of that study?
5 A The results of that study were extremely
6 promising and I think very surprising to NIDA in
7 that we, one of the common concerns that NIDA had
8 put forth was that we know that marijuana hurts the
9 immune system, how could you possibly talk about
10 using marijuana with people who are immuno-compromised? And
11 what Dr. Abrams found is that
12 marijuana did not hurt the immune system, did not
13 increase viral load, did not negatively interact
14 with the protease inhibitors and actually did
15 facilitate, increase caloric intake as well as
16 weight gain, and also oral THC was included in this
17 study as well as a placebo.
18 JUDGE BITTNER: What is viral load?
19 THE WITNESS: Viral load is just the
20 quantity of virus in the blood, how much HIV there
21 actually is.
22 BY MS. CARPENTER:
0526
1 Q And you've referred to protease
2 inhibitors. Can you just explain briefly what
3 those are?
4 A Well, those--
5 Q What they do?
6 A What they seem to do is to inhibit the
7 replication of the virus, so that people can, you
8 know, and so that people can end up a little bit
9 healthier and that their immune system can then
10 fight better the reduced levels of virus that are
11 still there.
12 Q Okay. And that's basically a treatment
13 for AIDS now?
14 A Yes, yes, that--
15 Q For HIV?
16 A Yeah, and there's cocktails where they get
17 multiple different protease inhibitors at the same
18 time because the virus mutates and so it's pretty
19 much the standard treatment now for HIV.
20 Q Were there other FDA approved research
21 products that you're aware of that NIDA refused to
22 sell marijuana for use in?
0527
1 A After Dr. Abrams was unable to purchase
2 NIDA for the study that we had designed, I started
3 working with a Dr. Ethan Russo, and Dr. Ethan Russo
4 is a neurologist with an expertise in migraines and
5 so he tried several times to submit a protocol that
6 was seeking funding from NIDA, and so that protocol
7 was rejected several times, and then we decided
8 that it was really silly for us to try to ask for
9 money from NIDA for a study looking at the benefits
10 of marijuana. That's not NIDA's mission.
11 We felt that we'd never succeed in getting
12 marijuana from NIDA for that, so then we decided
13 that we would try to fund the study ourselves and
14 just ask for NIDA for the marijuana. So Dr. Russo
15 submitted the protocol to the FDA and to his own
16 institutional review board. He got permission from
17 both the FDA and the institutional review board,
18 and then submitted it to NIDA for the marijuana,
19 and NIDA refused to provide the marijuana.
20 Q And again, I'm sorry. Just to be clear.
21 What was this test--what were you seeking to use
22 the marijuana?
0528
1 A Well, this was for migraine, migraine
2 headaches. You know supposedly, you know, Queen of
3 England, Queen Elizabeth used marijuana for
4 migraines. There's historical use of marijuana for
5 migraines, and Dr. Russo felt that it should be
6 explored and it could be quite helpful.
7 JUDGE BITTNER: Which Queen of England?
8 Which Queen Elizabeth?
9 THE WITNESS: I think Queen--I think it
10 was around the time of the American Revolution,
11 Queen Elizabeth. I'm not--
12 JUDGE BITTNER: Well, not the current one.
13 THE WITNESS: Not the current one, no, no.
14 No, no. Hundreds of years ago.
15 JUDGE BITTNER: All right. The first one,
16 1558-1603, that one.
17 THE WITNESS: I'm not sure actually.
18 JUDGE BITTNER: Okay. All right. There
19 was--
20 THE WITNESS: I'm not sure.
21 JUDGE BITTNER: You simply had heard that
22 some monarch of England had used marijuana for
0529
1 migraines.
2 THE WITNESS: Yes, yeah. Dr. Russo would
3 know.
4 JUDGE BITTNER: Okay. Okay.
5 THE WITNESS: Yeah.
6 BY MS. CARPENTER:
7 Q And just roughly what time period was
8 this?
9 A This was like '96, '97, '98, '99, in that
10 time period because it was quite an extended
11 process.
12 Q Okay. So, and again, the FDA had approved
13 this particular protocol of Dr. Russo's that was
14 submitted?
15 A Yes, yes, they had. Yes, they had.
16 Q And his IRB?
17 A And the institutional review board had
18 also approved it, and if we would--
19 Q Was that all before it was submitted to
20 NIDA?
21 A Yes, it was. Yes, it was.
22 Q Are you aware of any other instances in
0530
1 which NIDA has refused to allow the purchase of
2 NIDA marijuana not in clinical studies but in
3 scientific investigational studies?
4 A Yes, I am. One of the areas of research
5 that MAPS has been involved with has been the
6 development of non-smoking delivery systems. As we
7 heard from Dr. Barbara Roberts, the Institute of
8 Medicine, recommended the development of non-smoking
9 delivery systems, and while I think it
10 needs to be decided experimentally what the
11 relative risks of are smoked marijuana versus
12 vaporized marijuana, we felt that it was essential
13 for us to try to develop a vaporizing device that
14 would eliminate the combustion products from
15 marijuana and that would deliver a, quote, "safer"
16 combination of drugs of ingredients to patients.
17 And so with Dr. Gieringer, we started a
18 whole series of students working--initially we
19 looked at water pipes because the common
20 understanding was that water pipes filtered out a
21 lot of gunk from the marijuana smoke and that they
22 might be a safer delivery system. And that initial
0531
1 research was with marijuana from NIDA, that they
2 were willing to supply, and it showed that water
3 pipes were not helpful, that they actually filtered
4 out cannabinoids as well as well as particulate
5 matter and that the smoke at the end of it was
6 pretty much the same proportions as the smoke
7 before, and so they were not helpful, but we had
8 early hints that vaporizer research might actually
9 be the way to go.
10 And so we then started working with Chemic
11 Labs in Massachusetts to do research and two years
12 ago, Chemic applied to NIDA to purchase ten grams
13 and also applied to import ten grams from the
14 Dutch. The Dutch have since complied with all
15 international treaty regulations according to the
16 DEA and according to them, and so now it seemed
17 like it would have been possible to import from the
18 Dutch and so Chemic applied to DEA for import
19 permit and to NIDA to purchase ten grams.
20 Q And what would be the purpose of getting
21 the marijuana for--what would Chemic do with the
22 marijuana?
0532
1 A Well, Chemic would then do studies in the
2 laboratory testing out the vaporizing device to
3 really see what was in the vapor, and NIDA
4 marijuana has virtually no CBD, cannabidiol,
5 another one of the main active ingredients, but the
6 marijuana from the Dutch had, they had available
7 high CBD marijuana and so we wanted to see how the
8 vaporizer device worked for THC, how it worked for
9 CBD, and to use this as preliminary information to
10 submit to FDA about how this device was working.
11 Q Would that have been used in patients at
12 all?
13 A Well, Chemic only does laboratory
14 analysis.
15 Q Okay. So this was not a protocol for use
16 with clinical research?
17 A No, no, it was not at all intended ever
18 for humans. It was just basic research trying to
19 understand how the device worked and what was the
20 composition of the vapor.
21 Q Okay.
22 JUDGE BITTNER: And I'm sorry. What is
0533
1 CBD again?
2 THE WITNESS: Oh, oh, cannabidiol.
3 There's--
4 JUDGE BITTNER: You get to spell that one.
5 THE WITNESS: Like Cannabinoid,
6 cannabidiol.
7 JUDGE BITTNER: D-Y-O-L? D?
8 THE WITNESS: D-I-O--diol--cannabi-D-I-O-L. C-A-
9 N-N-A-B-I-D-I-O-L.
10 JUDGE BITTNER: And THC is
11 tetrahydrocannabinol.
12 THE WITNESS: Yes.
13 JUDGE BITTNER: Without any numbers in
14 front of it?
15 THE WITNESS: Well, Delta-9 THC is what
16 they say.
17 JUDGE BITTNER: Okay. Okay. That's the
18 THC.
19 THE WITNESS: There is a company in
20 England, GW Pharmaceuticals, that has their own
21 marijuana farm in England and they manufacture
22 marijuana extract, and theirs is a combination of
0534
1 THC and CBD and pretty much a one-to-one ratio.
2 JUDGE BITTNER: Okay. But when you refer
3 to THC, you're referring to the Delta-9 one?
4 THE WITNESS: Yes, yes.
5 JUDGE BITTNER: Okay.
6 BY MS. CARPENTER:
7 Q I'd ask you to turn to Exhibit 14 in
8 Respondent's Exhibits.
9 MR. BAYLY: Sorry. What was that number?
10 MS. CARPENTER: Exhibit 14.
11 MR. BAYLY: Thank you.
12 THE WITNESS: Okay.
13 BY MS. CARPENTER:
14 Q Have you seen this letter before, Dr.
15 Doblin?
16 A Yes. This is the letter from Dr. Nora
17 Volkow, the Director of NIDA, to me.
18 Q Exhibit 14?
19 A Oh, is that the wrong exhibit?
20 Q It should be a letter to Dr. Volkow.
21 A Oh, okay. So 14 is the letter. Yes, I
22 see that.
0535
1 Q Okay. And what's the date on that?
2 A The date is May 19, 2004.
3 Q Okay. And did you write this letter?
4 A Yes, I did.
5 Q Did you send it?
6 A Yes, I did.
7 Q Okay. And what was the purpose of the
8 letter?
9 A The purpose of the letter was to appeal to
10 Dr. Volkow and to see if she would be able to get
11 some decision made on the application that Chemic
12 Laboratories had made to NIDA to purchase the
13 marijuana. This was now almost a year after they
14 had initially submitted their application, and we
15 still had not heard from this NIDA review company,
16 review process, whether the protocol was going to
17 be considered scientifically meritorious or not.
18 And so I outlined the time of the
19 interactions, various dates of the interactions
20 that we'd had with NIDA, with HHS, with Mr. Joel
21 Egertson, who is going to be a DEA witness. So we
22 outlined what had happened, and then I also talked
0536
1 about the application from Professor Craker to DEA
2 for the license which we still at this point had
3 not heard from DEA, and I was appealing to Dr.
4 Volkow to help us resolve this, and I also
5 mentioned that Senators Kennedy and Kerry had
6 written a letter expressing their support for UMass
7 Amherst licensing.
8 Q Okay. And in the second paragraph there
9 where it says Chemic Laboratory, a DEA licensed
10 analytical lab, applied to NIDA to purchase ten
11 grams of marijuana for use. Do you explain there
12 what the purpose is of the Chemic requirement?
13 A Well, the Chemic Labs, I was explaining
14 that it was to do--an analytical lab to study the
15 vapors of marijuana when it's heated but not
16 burned. So I--and what I also said is that this
17 excessively lengthy review process completely
18 undermines any program of research.
19 Q So at that point it had been a year?
20 A Almost a year.
21 Q Okay.
22 A Yeah.
0537
1 Q And then if you would turn back in the
2 notebook but forward in time--
3 A Okay.
4 Q --to Exhibit 13.
5 A Okay. Yes, I see that.
6 Q What's the date of that letter?
7 A The date is June 9.
8 Q Okay.
9 A So it's about three weeks after I sent my
10 letter.
11 Q And you've seen this document before?
12 A Yes, I have.
13 Q What is it?
14 A This is a letter to me from Dr. Volkow
15 responding to my letter and what she says is that
16 there's nothing she can do, that NIDA is only one
17 part of the review process, that there's also a HHS
18 review panel that has to do it. She didn't tell me
19 where it was in the process or who I should contact
20 or anything like that. She just said, you know,
21 NIDA is not only the one that's doing this.
22 I can't help you and then she said that,
0538
1 quote, "It is not NIDA's role to set policy in this
2 area or to contribute to the DEA licensing
3 procedures. Moreover, it is also not NIDA's
4 mission to study the medicinal uses of marijuana or
5 to advocate for the establishment of facilities to
6 support this research."
7 Q Okay.
8 A I should add that I was very disappointed
9 to get this letter.
10 Q So then did you hear anything else about
11 the Chemic request to get ten grams of NIDA
12 marijuana?
13 A Well, at this point, it had been about
14 three years since Dr. Craker had applied to DEA for
15 his license and it had been about a year since
16 Chemic had applied, and we really were getting no
17 information on either of these projects and so I
18 felt that it was necessary to sue DEA and HHS in
19 the D.C. Circuit Court of Appeals for unreasonable
20 delay.
21 Q Did you do that?
22 A Yes, we did.
0539
1 Q When was that?
2 A That was shortly after, after this letter.
3 Q And what was the result of that lawsuit?
4 A Well, the result was twofold. The D.C.
5 Circuit Court of Appeals asked DEA to explain why
6 they had taken three and a half years. The DEA had
7 to respond to the court as to the, you know, what
8 the purposes of the delay was, whether it was
9 justified.
10 And the court, on the other hand,
11 dismissed the case without prejudice against NIDA,
12 apparently concluding that it was not unreasonable
13 delay for NIDA to have taken this far, that long, I
14 mean to review it.
15 DEA then decided rather than to respond to
16 the court about why the delay was justified, they
17 decided to finally reject Dr. Craker's application
18 and then they issued the order to show cause, and
19 what eventually happened is that last week, we
20 finally heard from NIDA about the review of
21 Chemic's application, which they rejected.
22 MS. CARPENTER: Okay. And I have a new--it's a
0540
1 new exhibit that we talked about before. It
2 doesn't have a number yet, so I'll ask the clerk to
3 number it. I guess it would be Respondent's
4 Exhibit 50--I had it and I lost it--I think it's
5 52. 52.
6 JUDGE BITTNER: And it is five pages,
7 consisting of, it looks like two letters.
8 MS. CARPENTER: That's correct, Your
9 Honor. And if I could just ask the witness--when
10 you're ready--if the witness could have the
11 exhibit? Thanks.
12 And if I could just check with the Court
13 because I have not been circling my exhibits as I
14 usually do when they're admitted. I'm not sure
15 whether I moved the admission of Exhibits 15, 14
16 and 13?
17 JUDGE BITTNER: No, you haven't.
18 MS. CARPENTER: I would like to do that
19 now.
20 JUDGE BITTNER: Okay.
21 MR. BAYLY: No objection.
22 JUDGE BITTNER: I have another one of
0541
1 these questions. Maybe I answered it. Okay.
2 Let's see. 13 is received. Oh, on 14, in the
3 fourth paragraph, you refer to RADM Arthur
4 Lawrence.
5 THE WITNESS: Yes.
6 JUDGE BITTNER: What does RADM mean?
7 THE WITNESS: Rear Admiral.
8 JUDGE BITTNER: Is that the correct
9 acronym, all caps like that?
10 THE WITNESS: Yeah, that's the way he used
11 it in some of his e-mails to me.
12 JUDGE BITTNER: Okay. That's interesting.
13 Okay. 13, 14 and 15 are received.
14 MS. CARPENTER: Thank you, Your Honor.
15 JUDGE BITTNER: Actually, I had already
16 received 15.
17 MS. CARPENTER: Okay. I had that one in,
18 and then I thought--all right. Just want to be
19 clear they're all in.
20 JUDGE BITTNER: No, 14 and 13 I had not.
21 Okay.
22 MS. CARPENTER: Great.
0542
1 [Respondent's Exhibits Nos. 13
2 and 14 were marked for
3 identification and received in
4 evidence.]
5 BY MS. CARPENTER:
6 Q Dr. Doblin, have you seen what has been
7 marked as Respondent's Exhibit 52 before?
8 A Yes.
9 Q And is that two documents?
10 A Yes, it is. The first one is a letter to
11 me from the President of Chemic Labs, and the
12 second document is Joe St. Laurent from Joel
13 Egertson.
14 Q And Joe St. Laurent is the President of
15 Chemic Labs?
16 A Yes, he is.
17 Q And Joel Egertson, he is?
18 A I'm not sure his formal title, but he was
19 the Special Assistant on Drug Policy to the
20 Secretary of HHS.
21 Q Okay.
22 A And he has a similar position now.
0543
1 Q That's fine. He's with the government?
2 A Yes, he's with HHS.
3 Q Okay. And did you receive the letter to
4 Joseph St. Laurent from Mr. St. Laurent? Did he
5 forward that letter to you?
6 A Yes, I did. He sent it to me.
7 Q Okay. Did he send it to you at the same
8 time as he sent the letter to yourself?
9 A No, no. He sent me the letter first and
10 then he sent me the letter he had received from
11 Joel Egertson first and then we talked it over and
12 then I asked him to send me a letter just outlining
13 briefly his response. He's working on a longer
14 letter to respond to Dr. Egertson, but--
15 MS. CARPENTER: Okay. All right. So I
16 would move the admission of Exhibit 52 into
17 evidence at this time.
18 MR. BAYLY: Mr. Bayly?
19 MR. BAYLY: Is that both letters?
20 MS. CARPENTER: Both letters.
21 JUDGE BITTNER: Yeah.
22 MR. BAYLY: Yeah, I think I won't object
0544
1 to them. I know we all just got them recently, but
2 probably it should be 52A and 52B, something like
3 that.
4 JUDGE BITTNER: That would be a good idea.
5 MS. CARPENTER: That's fine.
6 JUDGE BITTNER: So A is the letter on top,
7 and that doesn't have a date, but it was faxed on
8 August 17 apparently.
9 MS. CARPENTER: Right.
10 JUDGE BITTNER: That's 52A. And 52B is
11 the July 27 letter from HHS.
12 MS. CARPENTER: To Chemic, right.
13 JUDGE BITTNER: I'm sorry. 52B--
14 MR. BAYLY: Wait a minute. Judge Bittner,
15 okay, I'm sorry. I think I have missing one of the
16 letters or I was not looking at one of them.
17 MS. CARPENTER: There's--
18 MR. BAYLY: Okay. This is--you know, I
19 just got a duplicate. The first letter is from
20 Chemic Labs to Rick Doblin. Is that it?
21 MS. CARPENTER: That's correct.
22 JUDGE BITTNER: Correct. Undated fax.
0545
1 MS. CARPENTER: 52A.
2 MR. BAYLY: Yeah, well, the fax was sent
3 to us. It looks like there's a fax of 8/17/05, but
4 other than that, there's no date on this.
5 MS. CARPENTER: Right.
6 JUDGE BITTNER: Right.
7 MS. CARPENTER: That's the date it was
8 faxed to Dr. Doblin.
9 MR. BAYLY: Okay. So we don't know when
10 this was written?
11 JUDGE BITTNER: Right. But we know when
12 it was gotten.
13 MS. CARPENTER: When it was sent.
14 JUDGE BITTNER: And sent.
15 MS. CARPENTER: And Dr. Doblin just
16 testified that it was written between the date of
17 the receipt of this letter and the date it was
18 faxed.
19 MR. BAYLY: Okay. No objection.
20 JUDGE BITTNER: Okay. And then 52B would
21 be the July 27 letter to Mr. St. Laurent.
22 MS. CARPENTER: Right.
0546
1 JUDGE BITTNER: Before I receive them,
2 what's Respondent 51?
3 MS. CARPENTER: I think it's a letter--
4 JUDGE BITTNER: That hasn't been offered
5 yet?
6 MS. CARPENTER: Right.
7 JUDGE BITTNER: Because I don't have it.
8 MS. CARPENTER: It has not been offered,
9 right.
10 JUDGE BITTNER: Okay. Okay.
11 MS. CARPENTER: Right. Yes, we're jumping
12 around.
13 JUDGE BITTNER: Okay. 52A and 52B are
14 received.
15 [Respondent's Exhibits Nos.
16 52A and 52B were marked for
17 identification and received in
18 evidence.]
19 BY MS. CARPENTER:
20 Q All right. Let's start with 52B, the
21 letter from HHS to Chemic.
22 A Okay.
0547
1 Q Do you know what that is?
2 A Yes, this is the letter from Dr. Egertson
3 explaining that finally after two years the Public
4 Health Service had reviewed the protocol and had
5 rejected it.
6 Q Okay. And do you know why they rejected
7 it?
8 A Well, I know why they say they rejected
9 it.
10 Q Okay.
11 A And they claim that the protocol is
12 without scientific merit and they make a series of
13 specifics which seem initially, they try to relate
14 it to the provisions that HHS has established for
15 selling marijuana to privately funded projects.
16 And their first claim is that it doesn't seem like
17 it's a clinical study, and that they're
18 prioritizing clinical research, and that it isn't a
19 clinical study.
20 They claim that furthermore that our--
21 MR. BAYLY: Excuse me, Dr. Doblin. I'm
22 going to object here. I think we've, I don't know
0548
1 if we've got any proffer to have Dr. Doblin testify
2 to interpret the letter. I think the letter does
3 speak for itself, so I am not sure where we're
4 going with having a speculation on what the author
5 of the letter meant. I guess that's another
6 objection that we need to have not the witness
7 project what he thinks what the author of the
8 letter has said.
9 JUDGE BITTNER: Ms. Carpenter?
10 MS. CARPENTER: I was trying to avoid
11 having to go through it bit by bit by summarizing,
12 but we can go through bit by bit if we--what's the
13 preference?
14 JUDGE BITTNER: Well, I guess the question
15 is is it necessary to go through it at all?
16 MS. CARPENTER: Well, we think it is, Your
17 Honor, at least in a general way. Maybe I could
18 phrase the question this way.
19 BY MS. CARPENTER:
20 Q Did you talk with the President of Chemic
21 about the letter?
22 A Yes, I did.
0549
1 Q Okay. And what did he say to you about
2 the letter?
3 A He said that after two years with the
4 protocol that they still hadn't even read it
5 correctly, that they made some mistakes as far as
6 what his protocol was actually about, and that he
7 felt that the protocol, that he could address every
8 scientific criticism that they made of the protocol
9 and that he was surprised that they had rejected
10 it, and thought that it was political and that he
11 was going to reply and still continue to try to get
12 the marijuana from NIDA.
13 Q Okay. And has Chemic Labs, does it hold
14 any DEA licenses, to your knowledge?
15 A Yes, it does. It does. I think it's done
16 work with cocaine, cocoa leaves. It's a 40 person
17 analytical lab, and it has a lot of interaction
18 with DEA.
19 Q Okay. Does it work for major drug
20 companies?
21 A Yes, its business is a contract research
22 lab to the pharmaceutical industry. In the period
0550
1 of time that I've worked with it, it's grown from a
2 relatively small firm to, you know, 40 people now.
3 Q Okay. So given that you were aware of
4 various research protocols that had been FDA
5 approved that NIDA had refused to provide marijuana
6 for, and the difficulties in getting marijuana for
7 testing in a vaporizer, what did MAPS decide to do
8 next?
9 A Well, I felt that the way any
10 pharmaceutical drug development should be done is
11 that the pharmaceutical company needs to secure an
12 independent source of supply of the drug that they
13 want to test, and so I felt that it was essential
14 that we obtain our own supply and started working
15 on that.
16 Q And what would that supply be used for?
17 A FDA and DEA approved research. You know I
18 specifically indicated that we would not try to
19 provide for patients who were approved by states,
20 but not for, but not approved by federal agencies,
21 that this is exclusively for federally approved
22 projects.
0551
1 Q Okay. So what did you do to try and move
2 that prong forward?
3 A Well, now this starts back in around 1999-2000,
4 after the two, Dr. Russo and Dr. Abrams,
5 protocols had been rejected, and so I, MAPS does a
6 lot of collaboration with scientists. So I first
7 off tried to think of who would be the kind of
8 person that I would like to work with.
9 Q Okay. Let me just step back for a minute.
10 I think I wanted to get in a couple more points
11 before we move on to that.
12 A Okay.
13 Q I guess you indicated that you needed
14 supply. Were there other concerns that you had
15 with obtaining marijuana for medical research?
16 A Yes. That from my understanding, NIDA is
17 authorized to provide marijuana for research, but
18 they are not in the business, as Dr. Volkow says,
19 of trying to support medical marijuana research nor
20 are they authorized by Congress to go into the
21 business of selling marijuana for prescription use.
22 And so what I wanted was a product that we
0552
1 could do the initial clinical studies with that we
2 would have a guarantee would be available for
3 prescription use should FDA decide that that would
4 be acceptable.
5 Q Okay. Were there issues about source that
6 also concerned you in terms of strains of marijuana
7 or quality of marijuana or--
8 A Yes. NIDA has a--NIDA's marijuana has
9 been low potency, low THC marijuana, and when you
10 do the risk-benefit analysis at FDA, when they are
11 faced with the risk-benefit analysis of a drug, the
12 higher potency marijuana means that people would
13 inhale smaller percentage of particulate matter per
14 therapeutic cannabinoids. So I felt that we needed
15 to experiment with higher potency strains and then
16 we also needed to experiment with strains that had
17 other cannabinoids in it as well as THC.
18 Q Okay. Were there also concerns that MAPS
19 had regarding quality of marijuana from NIDA?
20 A Oh, yes. Yes, NIDA's marijuana, recently
21 in response to our effort actually, NIDA has
22 claimed that they've got a focus on quality, but in
0553
1 the past, their marijuana would be filled with
2 seeds and sticks and stems and was not, it was
3 made--actually the fact that it was seeds, you
4 know, demonstrates that it was not separated
5 plants.
6 The female plants are the ones without the
7 seeds that are the higher potency and that's what I
8 think is more desirable and would be more likely to
9 make it through the FDA risk-benefit analysis and
10 so we were very concerned with NIDA quality. It's
11 old, it's harsh, it's stored for years sometimes,
12 and we felt it was an inadequate product.
13 Q Have you talked to particular patients who
14 have experienced NIDA marijuana?
15 A Yes. There are seven patients right now
16 that legally receive marijuana from NIDA and I've
17 spoken to quite a few of them about their concerns.
18 None of them individually wants to criticize the
19 NIDA quality for fear that their supply would be
20 cut off, but I also felt that we needed to do some
21 sort of study of these seven patients, and Dr.
22 Russo did a study with these patients and there
0554
1 were issues of the quality that were presented to
2 him that then he reported in his paper on that.
3 Q Okay. Would you turn to Exhibit 19?
4 A Yes, I see it.
5 MS. CARPENTER: And Your Honor, before we
6 go further with that, I just wanted to be clear.
7 This was one of the exhibits that you had excluded
8 in part. We're going to be looking--I'm not--
9 JUDGE BITTNER: Would you like to identify
10 the part?
11 MS. CARPENTER: Well, that's what I was
12 going to try to do. It's a little bit difficult
13 and I feel a little like the Exhibit 1 that we
14 talked about yesterday, in that I believe it ought
15 to be received in whole so that the context is
16 complete. But if we--I had this marked in my other
17 copy.
18 JUDGE BITTNER: Could I ask the witness
19 something about female marijuana while you look?
20 MS. CARPENTER: Of course.
21 THE WITNESS: Yes, yeah.
22 JUDGE BITTNER: We won't go through my
0555
1 undergraduate training in botany, but you said the
2 female plants don't have seeds?
3 THE WITNESS: Well--
4 JUDGE BITTNER: Does that mean the male
5 plants do?
6 THE WITNESS: Well, what, well, the buds,
7 the growers separate--to get the higher potency
8 pot, you don't want the buds to go to seed.
9 JUDGE BITTNER: Okay.
10 THE WITNESS: And so the female plants can
11 have seeds, but you try to prevent that from
12 happening. But you separate the male and the
13 female plants. The male, the pollen that would
14 germinate the buds and then turn it into seeds.
15 And so what frequently is done is the female plants
16 are separated from the male plants so they don't go
17 to seed.
18 JUDGE BITTNER: Do the male plants
19 produce--the male plants don't produce seeds; do
20 they?
21 THE WITNESS: They have pollen, yeah.
22 JUDGE BITTNER: Okay.
0556
1 THE WITNESS: And the male plants tend to
2 be lower potency as well.
3 JUDGE BITTNER: I won't comment.
4 [Laughter.]
5 MS. CARPENTER: Though I'm sure you're
6 sorely tempted.
7 BY MS. CARPENTER:
8 Q Dr. Doblin, if you would turn to page 47
9 and that's 47 of the article number, the article
10 page, since it's a separate article.
11 A Okay. I'm there.
12 Q And beginning with the problems of the
13 Compassionate IND program, and I think that's the
14 relevant section that we would be talking about.
15 A Yes.
16 Q Have you seen this document before?
17 A Yes, I have. MAPS helped fund the study.
18 Q Okay. And who wrote it?
19 A Dr. Russo was the lead author of this.
20 Q Okay. And this was a published article?
21 A Yes, it was.
22 Q What was it published in?
0557
1 A The Journal of Cannabis Therapeutics.
2 Q And what was the date?
3 A The date of this is 2002.
4 MS. CARPENTER: Okay. Your Honor, at this
5 point, I would move the admission of Exhibit 19
6 into evidence, either the whole thing if there's no
7 objection, or from page 47 through the end if there
8 is.
9 JUDGE BITTNER: Okay. Mr. Bayly?
10 MR. BAYLY: Well, I think if we can do it
11 consistent with how we did the IOM, I won't object
12 to the whole exhibit being admitted as long as we
13 stipulate that the only relevant evidence is from
14 47, basically the anecdotes of the patients'
15 complaints, and I think that would be from 47
16 through, well, 51, it looks like.
17 MS. CARPENTER: Right. But I'd just like
18 to be clear. I don't think was the stipulation
19 with regard to the IOM in which the entire exhibit
20 came in.
21 JUDGE BITTNER: Well, are you willing to
22 so stipulate?
0558
1 MS. CARPENTER: I will for this one. I
2 just want to be clear that that was not my
3 stipulation with regard to the IOM.
4 JUDGE BITTNER: Okay. So actually I would
5 assume--dangerous spot--that what we're really
6 stipulating to is that I can look at the entire
7 thing, but the portion that everyone agrees is
8 relevant is from the heading "Problems in the
9 Compassionate IND Program" through the third full
10 paragraph on page 51, i.e., up to Conclusions and
11 Recommendations?
12 MS. CARPENTER: Let me just check.
13 JUDGE BITTNER: Except that probably
14 Respondent would like to have recommendation eight
15 on page 52 in.
16 MS. CARPENTER: I was just going to say I
17 think there's certainly one recommendation, yes.
18 JUDGE BITTNER: Would you agree to that,
19 Mr. Bayly?
20 MR. BAYLY: This was under the conclusions
21 and recommendations?
22 JUDGE BITTNER: Right. On page 52, number
0559
1 eight.
2 MS. CARPENTER: Number eight.
3 MR. BAYLY: Yes.
4 JUDGE BITTNER: Okay. With that caveat,
5 Respondent 19 is received.
6 [Respondent's Exhibit No. 19
7 was marked for identification
8 and received in evidence.]
9 MR. BAYLY: I just want to clarify. Mrs.
10 Carpenter said that we didn't have any similar
11 agreement on the IOM. I'm not agreeing with that.
12 I don't know that we were able to parse the IOM out
13 as easily as we could this. This looked like it
14 was easier to segregate the pages that were
15 relevant, but I still believe that the IOM has to
16 be limited in the context of your order, Judge
17 Bittner, so I guess whatever we said speaks for
18 itself, but I just wanted to make sure that we're
19 not now conceding that the whole IOM report goes in
20 uncontested.
21 JUDGE BITTNER: Well, we will devoutly
22 hope that I made it clear yesterday because I'm
0560
1 sure I couldn't repeat it. Okay.
2 So is this is a good breaking time or you
3 want to go on with something else?
4 MS. CARPENTER: That's fine with me, Your
5 Honor.
6 JUDGE BITTNER: Because I've lost my pen.
7 So let's take a ten minute break. Off the record.
8 [Whereupon, a short recess was taken.]
9 JUDGE BITTNER: On the record.
10 BY MS. CARPENTER:
11 Q Dr. Doblin, we had just started talking
12 about Exhibit 19, starting at page 47. I think you
13 indicated that you're familiar with this study.
14 A Yes, I am.
15 Q You've read the study?
16 A Yeah, helped fund it, read it, yes.
17 Q Okay. And you've talked with Dr. Russo
18 about that as well?
19 A Yes.
20 Q Okay. First of all, do you know how many
21 patients were studied in this particular study?
22 A Four. There are seven patients. Several
0561
1 of them were too scared to even be in the study.
2 They felt that this might impact NIDA's willingness
3 to continue to provide them with marijuana so they
4 declined to participate in the study.
5 Q Okay. And let me step back just a minute.
6 This is the Compassionate IND Program. Can you
7 explain what that is?
8 A Yes. This was started almost 30 years
9 ago. What happened is that there were several
10 people that were--it started with Bob Randall. Bob
11 used marijuana for glaucoma, was arrested for it,
12 went to trial and was able to convince the judge
13 that he would continue to need this marijuana and
14 that he would be recycling in and out of the legal
15 system, and so he was able to assert a medical
16 necessity defense.
17 And NIDA agreed, in order to keep him from
18 bouncing back and forth in the court system, to
19 provide him with marijuana as part of a special
20 compassionate IND program.
21 However, no data was gathered so it's not
22 like a normal FDA research program where subjects
0562
1 are studied. This is an open-ended program, and in
2 the late '80s and early '90s in response to the
3 AIDS epidemic and many, many patients using
4 marijuana for the nausea control and AIDS wasting,
5 this program started getting lots of applicants to
6 be admitted into this program, and FDA approved
7 about 35 people to be in the program, but NIDA
8 didn't want to provide them with the marijuana.
9 And I think in 1992, James Mason, who was
10 in HHS, announced that they were closing the
11 program to new entrants. Even though FDA had
12 approved a group of them, they were not going to be
13 provided marijuana. And so now what seems to be
14 happening is that the NIDA is going to wait for
15 these seven people to die, and then the program
16 will be closed.
17 Q Okay. And so the purpose of the people
18 being in this program is for medical use for
19 marijuana?
20 A Yeah. The purpose is--
21 Q And what's required for them to--what was
22 required for them to be approved by the FDA?
0563
1 A They had to have their doctors submit
2 evidence to FDA. Initially, some of the people
3 were granted medical necessity defense in courts
4 and then NIDA decided to provide them with
5 marijuana and then later procedures were developed
6 so people didn't have to go to the courts, that
7 they could apply directly to FDA for--FDA to review
8 their doctor statements and their medical records
9 and then FDA would approve some people for entrance
10 into this program. And that's where it's at.
11 Q Okay. So as you read this article,
12 particularly starting with the problems in the
13 Compassionate IND Program, is it your understanding
14 that NIDA provides all the marijuana for that
15 program?
16 A Yes, yes, NIDA does.
17 Q Okay. And what did Dr. Russo find in his
18 study about cannabis quality?
19 A Well--
20 MR. BAYLY: Your Honor, I have the same
21 objection I had before. If we're going to have the
22 witness interpret what Dr. Russo is saying, then
0564
1 that's not proper. You can't have one witness read
2 the mind of another witness. This article may
3 speak for itself to a certain extent, but the other
4 thing is I don't see anywhere in the prehearing
5 statement where Dr. Doblin was going to interpret
6 Dr. Russo.
7 MS. CARPENTER: Can I just ask a factual
8 question?
9 BY MS. CARPENTER:
10 Q Is this a study that MAPS sponsored?
11 A Yes, it is.
12 Q Helped fund?
13 A It is.
14 Q You participated in?
15 A Yes, we conceived of the idea and felt
16 that these patients should be studied. FDA wasn't
17 requiring them to be studied and so this is part of
18 our efforts to develop a body of scientific
19 literature to submit to FDA to use for the
20 development of marijuana as a prescription
21 medicine.
22 MS. CARPENTER: So since the witness has
0565
1 testified that he sponsored the study, I think it's
2 fair for him to characterize the results.
3 JUDGE BITTNER: I guess, again, this
4 problem of interpreting a document which is now in
5 evidence and the problem is since I didn't know
6 what parts of it were going to be introduced, I
7 didn't read it.
8 MS. CARPENTER: Of course not, Your Honor.
9 JUDGE BITTNER: Let me just very briefly
10 ask the witness a few questions about this, various
11 things that I don't necessarily understand.
12 CO is carbon monoxide?
13 THE WITNESS: Yes.
14 JUDGE BITTNER: On page 48?
15 THE WITNESS: Yes. Yes.
16 JUDGE BITTNER: What does oxidation do to
17 cannabis?
18 THE WITNESS: It tends to reduce the
19 potency of it over time.
20 JUDGE BITTNER: And the IND patients were
21 the--is this the same acronym, Investigational New
22 Drug?
0566
1 THE WITNESS: Yes, but Compassionate IND.
2 JUDGE BITTNER: Okay. I wonder what
3 happens to the lettuce? Anyway.
4 [Laughter.]
5 THE WITNESS: I don't think it gets
6 smoked.
7 JUDGE BITTNER: What's terpenoid?
8 THE WITNESS: Terpenes. They're just some
9 of the, you know, plant components that are not
10 cannabinoids in marijuana plant.
11 JUDGE BITTNER: Okay. I think, I think I
12 understand the rest so I don't see any point to
13 questions about it.
14 MS. CARPENTER: Okay. I'll just ask more
15 general questions about the results of the study
16 and not about this particular article.
17 JUDGE BITTNER: Okay. Okay.
18 BY MS. CARPENTER:
19 Q Since you helped fund the study and
20 sponsored it, what was your understanding about the
21 results of some of the--let me rephrase that--what
22 was your understanding of some of the concerns of
0567
1 the patients in the Compassionate IND Program about
2 the quality of the NIDA marijuana?
3 A The concerns of the patients were that
4 they had to, because of the low potency of the
5 marijuana, they had to smoke large quantities of it
6 and that it was harsh and unpleasant and that they
7 would have preferred to smoke less and would have
8 preferred, therefore, a higher potency and fresher
9 material, and that they were generally finding,
10 though, that this marijuana still worked for them,
11 but that the side effect profile of it was greater
12 than it would have otherwise been with a product
13 that they would have preferred.
14 Q Okay. And if you could turn to page 50.
15 A Okay.
16 Q I think you spoke earlier about one
17 problem with the NIDA cannabis having lots of seeds
18 and sticks. Is the picture on the bottom a picture
19 of the seeds and sticks you were referring to?
20 A Yes. And this is seeds and sticks from
21 just three marijuana cigarettes that had been
22 provided by NIDA. This is the kind of material
0568
1 that really doesn't contain hardly any THC. I mean
2 there's only like one percent THC in the seeds. I
3 mean one percent of the weight of the THC, of the
4 seeds is THC. So this is material that is
5 generally discarded.
6 Q Okay.
7 A The other picture is of the leaf and shows
8 that really they don't use the buds. It's just
9 leaf material.
10 Q And why is that significant?
11 A Well, the leaf again is lower potency THC.
12 The THC tends to be concentrated in the buds, so
13 when you're looking to try to produce a, you know,
14 safer product, you would go away from the material
15 that has lower amounts of THC, more towards the
16 buds.
17 Q Okay. And how would that make it safer?
18 A Just in terms of the ratio of particulate
19 matter that you need to ingest compared to the
20 therapeutic cannabinoids.
21 Q Okay. Dr. Doblin, are you familiar with a
22 man named Philip Alden?
0569
1 A Yes, I am.
2 Q How do you know him?
3 A Well, I've spoken to him several times and
4 I know him initially from newspaper article that I
5 read about how he was a medical marijuana patient
6 in a NIDA study.
7 Q Okay. Do you know what he suffers from?
8 A He has HIV.
9 Q Okay. And this marijuana study that
10 you're referring to, do you know who sponsored that
11 study?
12 A That was one of the CMCR studies that Dr.
13 Dennis Israelski--actually, excuse me, I'm wrong--San Mateo
14 County is the only county that actually
15 allocated money for medical marijuana research. So
16 that even though they're working CMCR, his study
17 was actually funded by San Mateo County rather than
18 the state of California.
19 Q Okay. But it was done through CMCR
20 research?
21 A Yes, they did it through the auspices of
22 that, but they had different funding.
0570
1 Q Okay. So this was an FDA approved
2 protocol research?
3 A Yes, it was.
4 Q And NIDA approved since they provided the
5 marijuana?
6 A Yes, yes.
7 Q Okay. And do you know what his thoughts
8 were about the quality of the NIDA marijuana that
9 he used during that study? What has he told you?
10 I should say that.
11 A Phil Alden personally told me that the
12 marijuana that he smoked in the NIDA provided
13 marijuana in the FDA approved study got, made him
14 sick, that he got bronchitis. That he had
15 previously been using a higher potency marijuana,
16 legal under California law, from buyers' clubs, and
17 that he had had no health problems and it actually
18 had enhanced his health.
19 And that once he had to start using the
20 NIDA marijuana, he got ill and his doctor told him
21 that it was from the low quality NIDA marijuana and
22 recommended that he withdraw from the study.
0571
1 Q What was the illness he contracted?
2 A Bronchitis.
3 Q Okay. Did he withdraw from the study?
4 A He did withdraw from the study.
5 Q And what happened?
6 A He was able then to return to higher
7 potency marijuana and has been able to use that
8 without any ill health effects, and the study
9 itself has not proceeded very far along because
10 they've had trouble getting subjects.
11 Q Okay. So we talked about MAPS, what MAPS
12 was thinking in terms of furthering the scientific
13 development of marijuana. You talked about needing
14 supply. You talked about concerns about NIDA's
15 quality. Were there also issues with the delivery
16 of marijuana as medicine that MAPS wanted to look
17 at?
18 A Yes.
19 Q You had spoken earlier about the water
20 pipe that you did and so--
21 A Yes, yes, I mean our concerns were that
22 when you burn marijuana, you produce certain
0572
1 combustion products and whether or not, to what
2 extent that is harmful is something that needs to
3 be evaluated through scientific studies, but
4 clearly when you vaporize marijuana, that seemed
5 like a step forward in terms of making the end
6 product safer, less likely to cause irritation to
7 the lungs.
8 Q So is it part of MAPS plan here to develop
9 an alternative delivery system?
10 A Yes. In fact, years ago after Dr. Russo
11 and Dr. Abrams' studies were approved by the FDA
12 but NIDA refused to provide the marijuana, I sort
13 of set out that there were two fundamental
14 prerequisites that we needed before we could really
15 justify spending the money on clinical research.
16 One of the prerequisites was that we
17 needed to develop vaporizers, a non-smoking
18 delivery system, in order to work with the FDA.
19 That would be more likely to make it through the
20 FDA than smoked marijuana and then the other was
21 that we needed our own independent source of
22 supply.
0573
1 Q Okay. Dr. Doblin, let me ask you to turn
2 to Respondent's Exhibit 12.
3 A Okay. Yes, I see that.
4 Q Has the FDA granted MAPS an orphan drug
5 designation for marijuana?
6 A Yes, yes.
7 Q And can you tell us what Exhibit 12 is?
8 A Exhibit 12 is a letter dated May 25, 1999.
9 It's from the Office of Orphan Products Development
10 of the FDA. It's a letter to me, and it indicates
11 that they have granted MAPS an orphan designation
12 for the use of marijuana for the treatment of HIV
13 associated wasting syndrome.
14 Q Okay. And what's the date on that? I'm
15 sorry?
16 A May 25, 1999.
17 Q And you received this letter from the FDA
18 or from HHS?
19 A Yes, I did.
20 MS. CARPENTER: Okay. At this time I
21 would move the admission of Respondent's Exhibit 12
22 into evidence.
0574
1 MR. BAYLY: Just looking, there's no
2 signatory on this. I mean I can't even--you can't
3 tell from the copy I have. There's not even a
4 printed signature, print block, much less a
5 signature. So--
6 MS. CARPENTER: You're right.
7 MR. BAYLY: We would need.
8 JUDGE BITTNER: I--okay.
9 THE WITNESS: That's true.
10 JUDGE BITTNER: I see sincerely yours,
11 squiggle.
12 MS. CARPENTER: Yeah. I first thought
13 that was a signature, but as I look closely, I'm
14 not sure.
15 THE WITNESS: Yeah.
16 BY MS. CARPENTER:
17 Q Do you have a signed copy of--
18 A I believe that I do. It was--
19 Q Yeah. This one probably came from the Web
20 site as it did.
21 A Well, normally we put the original
22 documents on the Web site, so I'm not sure why
0575
1 there's no signature. I think sometimes they have
2 a third page which is where they put the signatures
3 and maybe--
4 JUDGE BITTNER: Could it have not gotten
5 scanned completely?
6 THE WITNESS: That's also possible. I'll
7 check but I'm sure that it was signed and that it's
8 in the records of the Office of Orphan Products
9 Development, but I'll check and try to see about
10 getting a signed copy.
11 MS. CARPENTER: Okay. But you're
12 confident that when it came to your office, this
13 letter was signed?
14 THE WITNESS: Oh, yes, definitely.
15 BY MS. CARPENTER:
16 Q And this is the letter that came to your
17 office?
18 A Yes, it definitely is.
19 MS. CARPENTER: All right. I think on
20 that basis, Your Honor, I would move its admission.
21 JUDGE BITTNER: Mr. Bayly?
22 MR. BAYLY: Well, I think we still need to
0576
1 get some indication who signed it. So, and I'm
2 certainly not going to object if that can, you
3 know, perhaps--
4 JUDGE BITTNER: Yeah. This is a slightly
5 different situation--
6 MR. BAYLY: Somebody can find a copy--
7 JUDGE BITTNER: --because we don't have a
8 name.
9 MS. CARPENTER: Right.
10 JUDGE BITTNER: For anybody. So I think I
11 will withhold ruling on this pending some
12 indication of who signed it.
13 MS. CARPENTER: Okay.
14 JUDGE BITTNER: Preferably a copy of
15 whatever was signed. So ruling withheld on
16 Respondent 12.
17 [Respondent's Exhibit No. 12
18 was marked for
19 identification.]
20 MS. CARPENTER: Okay.
21 BY MS. CARPENTER:
22 Q In any event, it is your understanding
0577
1 that you do have an Orphan Drug designation granted
2 by the FDA?
3 A Yes. There was a roughly two-year process
4 of the application where FDA continually asked us
5 for additional information, which we provided on
6 multiple occasions and then we were awarded this
7 Orphan Drug designation.
8 Q Okay. And what has MAPS been able to do
9 with this Orphan Drug designation?
10 A Nothing actually because we weren't able
11 to get access to marijuana from NIDA. This was
12 specifically for AIDS wasting. Donald Abrams, Dr.
13 Abrams had a study to investigate marijuana for
14 AIDS wasting. NIDA refused to provide the
15 marijuana, and so we've not been able to develop
16 this.
17 Q When you have an Orphan Drug designation,
18 are you still required to develop the drug in the
19 same way as you would any other drug?
20 A Yes, yes.
21 Q It doesn't provide a shortcut for approval
22 somehow; does it?
0578
1 A No, no. What it does do is that it
2 provides a package of incentives. They will
3 advise, the FDA will advise you on the protocol.
4 There are financial incentives that don't apply to
5 a nonprofit because we don't pay taxes like a for-profit
6 company, and then there is the exclusive
7 right to market should you get all the data to
8 convince the FDA to approve it as a medication.
9 Q Okay. But in order to proceed with an
10 Orphan Drug designation development, you would have
11 to have the same things that you would to proceed
12 with a regular FDA or NDA package; is that right?
13 A Yes, the one difference is that because
14 it's a drug for a rare disease, FDA will sometimes
15 accept data from smaller groups of patients rather
16 than thousands and thousands of patients the way
17 they may want for other drugs.
18 Q Okay. Because it would be used in smaller
19 population?
20 A Yes.
21 Q Okay.
22 A And it may be harder to recruit patients
0579
1 for it.
2 Q Okay. Now, obviously you're aware of Dr.
3 Craker's application. That's the reason we're
4 here. How did you come to approach Dr. Craker?
5 Why did you call him?
6 A Well, I felt that MAPS needed our own
7 independent source of supply and so I started
8 trying to think about who we could work with that
9 might have a chance of obtaining approval from DEA,
10 and so I figured that since Dr. ElSohly was located
11 at the University of Mississippi, I decided that
12 first off I would want somebody that was affiliated
13 with a university.
14 And secondly, I wanted somebody who had
15 expertise in medicinal plants, somebody who was a
16 senior tenured faculty so that could, wouldn't be
17 worried about their career if they were to get
18 involved in this controversial issue and it would
19 be more difficult to pressure to withdraw the
20 application should such pressure be placed on them.
21 And I wanted somebody that had nothing to
22 do with marijuana legalization, that was really
0580
1 strictly interested in medicinal plants.
2 So I had my list of ideal criteria and
3 then I started searching around for somebody who
4 might meet that criteria.
5 Q And how did you find Dr. Craker?
6 A Well, there was a chain of about five
7 different people that led me to Dr. Craker.
8 There's people that were involved in botanical
9 medicines. There's a company called Orphan
10 Pharmaceuticals in Minnesota that specializes in
11 orphan drugs, and so they recommended someone and
12 eventually I reached Professor Craker in 2000.
13 Q Okay. So what did you do when you first
14 met him?
15 A Well, I talked to him on the phone. I
16 explained to him the problems that we had been
17 having getting access to marijuana, that my
18 commitment was, in a way, MAPS is part of the
19 conservative wing of, you know, medical marijuana
20 movement in the sense that we're focused on FDA
21 approved research rather than bypassing the FDA
22 through state initiatives.
0581
1 So I explained to Professor Craker that
2 our focus was on conducting research and trying to
3 work through the FDA process and that we'd been
4 unable to do so without our own independent source
5 of supply, and that I would like to contract with
6 him to grow for FDA and DEA approved projects and
7 that MAPS would provide a grant to the university
8 to cover the costs should he be interested in
9 trying to get a license to do this.
10 Q Okay. And what did he say?
11 A He invited me to come to visit him and to
12 talk it over further. And I did so, and we ended
13 up deciding that we would work together. I created
14 like a one-page memorandum of understanding about
15 our relationship and how it would work, and then
16 started trying to work through the university
17 system to see if he could get permission to
18 actually submit the application to DEA.
19 Q Okay. And so when you talked with Dr.
20 Craker, did you talk to him about the need for
21 different strains, different types of marijuana to
22 be grown?
0582
1 A I talked to him about the needs for
2 different strains, the problems with the quality of
3 the NIDA marijuana, the problems with access to
4 NIDA marijuana, the problems with the risks of
5 doing or the risks of trying to do marijuana
6 research with a drug that you wouldn't necessarily
7 have available for prescription use, and explained
8 that even though we were a small nonprofit, that we
9 wanted to operate just like a standard
10 pharmaceutical company, and that we wanted to work
11 with him on getting a supply that then we would
12 then take through all of the testing procedures.
13 Q Okay. And did you also talk with him
14 about the decision to try and find an alternative
15 delivery system for marijuana?
16 A Yes, yes, I talked about the value of the
17 vaporization approach to making, to reducing
18 potential problems to the lungs.
19 Q And did he agree to provide all this?
20 A Yes. Yes, he did.
21 Q You mentioned a memorandum of
22 understanding. What was in that?
0583
1 A Basically what it said is that MAPS would
2 cover all the costs, that any equipment that
3 Professor Craker needed to purchase would remain
4 the property of the university should we end the
5 contract, and that unlike standard for-profit
6 pharmaceutical companies that try to keep all the
7 information proprietary, MAPS as a nonprofit
8 believes in operating in a transparent way and
9 we're not trying to beat anybody to market and if
10 some pharmaceutical company were to take our
11 research and build on it and go faster, that would
12 be fine.
13 So I said that any information that
14 Professor Craker might get about the production of
15 marijuana, about particular strains, that all of
16 that would be theirs to do with, to publish, that
17 there would be no proprietary information
18 whatsoever, and that MAPS would then once a product
19 was produced that we would then indicate where it
20 should be used. And it would only be used in
21 government approved studies.
22 Q Okay. Did you have a whole line of people
0584
1 outside your door ready to, researchers lined up
2 with projects outside your door when you went to
3 see Dr. Craker?
4 A I had stopped trying to--the answer is no.
5 I had stopped trying to develop projects, research
6 projects. It's enormous expenditure of energy and
7 money to try to design a protocol, to try to get it
8 approved. It takes months, sometimes years to get
9 through all of the regulatory procedures, and I
10 just felt it was not worth investing time in trying
11 to have studies ready when I knew it might take--I
12 didn't think it would take this long, but I thought
13 it would take a long time for Professor Craker to
14 find out if he could get the license or not.
15 And so energy that I put was focused on
16 trying to do the vaporizer research and then trying
17 to get an independent source of supply. I know
18 that if we have an independent source of supply,
19 there is such a pent up demand for medical
20 marijuana research in a whole range of patient
21 populations, that it would not be difficult to then
22 start developing the projects.
0585
1 But I just felt it would be a diversion, a
2 waste in a different sense, diversion, a waste of
3 energy to try to actually get products to the point
4 where NIDA would again refuse to provide the
5 marijuana.
6 Q Okay. During your work with Dr. Craker in
7 developing how the growing would be set up and how
8 the relationship would be set up between you two,
9 were you aware of any political support that came
10 from the state of Massachusetts, for example?
11 A Yes, Professor Craker had told me that he
12 had been contacted by the state of Massachusetts
13 years before I contacted him about the possibility
14 of growing for the state for their own medical
15 marijuana program, and that that had not moved
16 forward because the state didn't have any money for
17 that, and that we felt that it was necessary to get
18 support from various congressional representatives
19 including Congressman Olver, whose district UMass
20 Amherst is in, and so we initially got a letter
21 from five Massachusetts congressmen to Asa
22 Hutchinson, the DEA Administrator at the time,
0586
1 expressing their support for this project.
2 Q Would you turn to Respondent's--I'm sorry--this is
3 the Government's Exhibit 54. I don't know
4 if you have that with you.
5 A I don't think I have the book of the
6 Government's Exhibits.
7 MS. CARPENTER: I can just bring that up.
8 MR. BAYLY: This is Government--
9 MS. CARPENTER: Government's Exhibit 54.
10 BY MS. CARPENTER:
11 Q Have you seen that document before, Dr.
12 Craker?
13 A Dr. Craker.
14 Q Sorry. Dr. Doblin.
15 A Yes, I have.
16 Q Okay. And what is that?
17 A This is the letter from Representative
18 Barney Frank, Representative James McGovern,
19 Representative Michael Capuano, Representative
20 William Delahunt, and Representative John Olver to
21 the Honorable Asa Hutchinson, the Administrator of
22 the DEA.
0587
1 Q Okay. And was it your understanding that
2 this letter was urging approval of Dr. Craker's
3 license?
4 A Yes, yes. This was a letter that started
5 out by saying that they applauded the policy of the
6 ONDCP and the DEA to support scientific and medical
7 research into this area, and that they were writing
8 to express the fact that it would be in the public
9 interest as representatives of the public for UMass
10 Amherst to be given a license to grow marijuana.
11 Q Okay. Was one of their interests there
12 that there be adequate competition in the area of
13 bulk manufacture of marijuana?
14 A Yes. They pointed out that since NIDA was
15 the sole source that that was, that that impeded
16 the medical marijuana research.
17 MS. CARPENTER: Okay. At this point, Your
18 Honor, I would move the admission of Government's
19 Exhibit 54 into evidence.
20 JUDGE BITTNER: Mr. Bayly?
21 MR. BAYLY: No objection.
22 JUDGE BITTNER: Received.
0588
1 [Government's Exhibit No. 54
2 was marked for identification
3 and received in evidence.]
4 BY MS. CARPENTER:
5 Q Dr. Doblin, do you currently have a
6 contract with the University of Massachusetts with
7 regard to the growth of--should they get the
8 registration?
9 A We have the memorandum of understanding,
10 and we have been--the answer is no. Not a formal
11 contract. For about the last, about a month and a
12 half ago or so, the Office of Grants and Contracts
13 forwarded their standard contract to Professor
14 Craker and one of the MAPS board of directors
15 suggested that we should plan for success in the
16 eventuality that the license might actually be
17 granted, and that we should try to formalize the
18 agreement with UMass Amherst to detail all of the
19 different aspects of that.
20 And so now we are reviewing the standard
21 contract that was submitted to us and modifying it
22 to our particular circumstances and then we'll
0589
1 submit it back to Professor Craker and the Office
2 of Grants and Contracts.
3 Q And how would you characterize your
4 relationship with Dr. Craker in the context of the
5 contract that you're negotiating, MAPS and Dr.
6 Craker's?
7 A Well, the relationship would be very
8 similar to the relationship that we had with the
9 manufacturer of the psilocybin and the manufacturer
10 of the MDMA, that Professor Craker would
11 manufacture the drug according to our requests for
12 certain kind of potencies, certain kind of strains.
13 He would then produce the marijuana and then MAPS
14 would allocate it to government approved projects,
15 first projects that MAPS was sponsoring and then
16 depending upon whether there was marijuana
17 available for other projects if people appealed to
18 us, that we would either provide it to free or at
19 cost through donations to MAPS to other researchers
20 who are not doing MAPS funded projects.
21 Q Okay. And who would actually send out,
22 who would distribute the marijuana, the medical
0590
1 marijuana for FDA approved research?
2 A Professor Craker would--MAPS at no point
3 would take possession of--
4 Q At your direction?
5 A --any of the marijuana. It would all be
6 under the secure facility that Professor Craker
7 would have established.
8 Q Okay. Dr. Doblin, are you aware whether
9 other developers of marijuana as medicine grow
10 their own marijuana?
11 A I'm aware that there is a company in
12 England, GW Pharmaceuticals, that has permission
13 from the home office for about the last six or
14 seven years, and they grow quite a large amount of
15 marijuana actually that they then use to produce
16 marijuana extracts and they've make this spray
17 under the tongue and they are actively engaged in
18 the development of this marijuana extract.
19 They've got approval in Canada for
20 marketing, and they're seeking approval in England
21 and will eventually try to move into the United
22 States market.
0591
1 Q Okay. Would you turn to Exhibit 26,
2 please? Respondent's Exhibit 26.
3 A Yes, okay.
4 Q Have you seen this document before?
5 A Yes, I have.
6 Q Do you know where it's from?
7 A Yes, this document is from the home office
8 in England, and it is their arrangement with GW
9 Pharmaceuticals and shows exactly how GW is
10 regulated to be in compliance with International
11 Drug Control Treaty obligations.
12 Q And how did you come to have this
13 document?
14 A Through the Steptoe and Johnson firm
15 that's working with us. That request was made to
16 the home office for provision of this document for
17 understanding how they regulate GW in compliance
18 with the treaties and so the home office
19 voluntarily provided it to us.
20 Q Okay. And is it your understanding that
21 the purpose of this United Kingdom National
22 Cannabis Agency protocol or at least the effect of
0592
1 it was to allow GW to grow their own marijuana and
2 hold on to the stocks?
3 A Yes, yes. This was designed in order to
4 meet all the necessary obligations that were
5 required by the international treaties.
6 Q Okay. And would one of those
7 international treaties be the Single Convention?
8 A That is the one that governs the
9 production of marijuana, yes.
10 Q The Single Convention on Narcotic Drugs?
11 A Yes.
12 MS. CARPENTER: Okay. All right. I would
13 move the admission of Exhibit 26 into evidence.
14 MR. BAYLY: Judge Bittner, I'd like to
15 request permission to voir dire the witness. I'm
16 just a little unclear on this exhibit. If I could
17 please.
18 JUDGE BITTNER: Okay.
19 VOIR DIRE
20 BY MR. BAYLY:
21 Q Dr. Doblin, do you have this in front
22 here, this 26?
0593
1 A Yes.
2 Q On the very top, it says United Kingdom
3 National Cannabis Agency. But I don't see any logo
4 for that. Is that a specific agency in the UK that
5 you're aware of?
6 A I'm not sure how it's structured in
7 England or if it's staffed with people that are
8 also part of the regular home office. So I'm not,
9 I think it does have some independent existence,
10 but I'm not sure of the staffing or where it is in
11 the bureaucratic system in England.
12 Q Okay. I understand you've had quite a bit
13 of experience litigating and so you probably do
14 have some background in laws and regulations; would
15 I be mistaken if I made that characterization?
16 A I don't have a whole--yes, I do have some
17 experience in litigating and was, yes.
18 Q All right. I'm trying to determine, Dr.
19 Doblin, is this is not, this is not a law like a
20 statute. This is not like similar to the
21 controlled substance statute; is it?
22 A No. No, this is like a regulation, I
0594
1 would guess. Or, well, how would you describe it--this is--
2 no, it's not a law. It's a procedure.
3 It's relating to the laws that England has
4 established as part of their participation in the
5 international drug control treaties.
6 Q So then is it your understanding that this
7 is interpreting the UK law?
8 A To the extent that the UK, you know,
9 signed on to the international treaties, this is an
10 interpretation of how they're supposed to comply
11 with the international drug control treaties.
12 Q Now, all right. As a predicate question.
13 You're familiar with some of the FDA and DEA
14 regulations that implement their statutes?
15 A Yes.
16 Q For example, well, there's many examples
17 of the regulations, but this exhibit here, 26,
18 that's not a--it doesn't purport to be a
19 regulation; does it?
20 MS. CARPENTER: I'm not sure the witness
21 is really qualified to answer these questions.
22 JUDGE BITTNER: Well, I think that's my
0595
1 problem with the exhibit, is the only, we don't
2 know who issued it, or how it came to be issued.
3 There's a reference on the last page to the Home
4 Office Drugs Branch.
5 MS. CARPENTER: Well, and it says the
6 United Kingdom Cannabis Agency shall come into
7 force with immediate effect, page number seven.
8 JUDGE BITTNER: Right, but we don't know
9 when immediate was because it's not dated.
10 MS. CARPENTER: Right. It came to us
11 undated.
12 JUDGE BITTNER: I think we need more
13 information about the document and how it got
14 generated and how it came to be.
15 MS. CARPENTER: Well, I think the witness
16 did testify that, you know, contact was made to the
17 United Kingdom Home Office asking them what their
18 protocol was for dealing with GW's growth of
19 marijuana and this was the response they sent back.
20 This is the protocol.
21 JUDGE BITTNER: Okay. Was the document
22 sent to you?
0596
1 THE WITNESS: No, no.
2 JUDGE BITTNER: It was sent to Steptoe and
3 Johnson?
4 THE WITNESS: Yes.
5 MR. BAYLY: I'm sorry. It was sent to
6 whom?
7 JUDGE BITTNER: The law firm Steptoe and
8 Johnson, somebody at the law firm.
9 THE WITNESS: Yes.
10 MR. BAYLY: Okay.
11 MS. CARPENTER: Who had submitted--
12 THE WITNESS: Yes, Emanuel Jacobowitz.
13 MS. CARPENTER: Right. Who had submitted
14 a request on behalf of Dr. Craker, yes, Dr. Craker.
15 JUDGE BITTNER: Do you know when he got
16 it?
17 THE WITNESS: I think it was probably
18 about three or four months ago.
19 MS. CARPENTER: We could certainly, you
20 know--
21 JUDGE BITTNER: I think we need more.
22 MS. CARPENTER: Okay.
0597
1 JUDGE BITTNER: I need to know, you know,
2 we've got a reference to the Home Office, but we
3 don't really know--
4 MS. CARPENTER: There was an e-mail that
5 sent this so we could certainly get the cover e-mail that
6 would show the e-mail in England from
7 where it came.
8 JUDGE BITTNER: Right. Because I mean I
9 really don't know, just the reference to the Home
10 Office, if this agency is going to be an office
11 within the Home Office Drug Branch, you would think
12 that the Home Office set it up, but we don't even
13 really know that.
14 I think I'd like to withhold ruling on
15 this until we know more. Are you comfortable with
16 that, Mr. Bayly?
17 MR. BAYLY: I'm sorry. What?
18 JUDGE BITTNER: That I withhold ruling on
19 this document because we don't know where it came
20 from or how it came, who established it.
21 MR. BAYLY: When would we address this?
22 MS. CARPENTER: Right. We could certainly
0598
1 provide the e-mail, the cover e-mail that came with
2 this, which would establish its provenance, if you
3 will. It will have the e-mail address and the name
4 of the person who sent it and the address of
5 presumably the Home Office.
6 JUDGE BITTNER: Well, I also, I guess I'm
7 kind of wondering if this is an official document
8 or not. See, without being on letterhead or
9 having, there's an address, but I don't know what
10 that address means. So I tell you what. Why don't
11 I just withhold ruling on it now and then we'll
12 talk later about what needs to happen.
13 MS. CARPENTER: That's fine, Your Honor.
14 Okay.
15 [Respondent's Exhibit No. 26
16 was marked for
17 identification.]
18 DIRECT EXAMINATION [continued]
19 BY MS. CARPENTER:
20 Q All right. I know you've testified a lot
21 about other places that you've tried to get a
22 supply of marijuana for medical research purposes,
0599
1 FDA approved research purposes, and I just want to
2 make sure that we haven't left--
3 A Oh. Also--
4 Q Can you just--
5 A I also tried to see if GW Pharmaceuticals
6 would provide marijuana for our research.
7 Q Okay.
8 A They felt that as long as they were
9 working with marijuana extract that they were
10 perceived as part of the solution, not part of the
11 problem, but if they were to actually provide us
12 with marijuana in plant form for research, that
13 then the perception at DEA and FDA might be that
14 they were perceived as part of the problem, not the
15 solution. So they declined to provide any to us.
16 Q And why would GW Pharmaceutical be
17 concerned about how FDA or DEA perceives them?
18 Aren't they a United Kingdom company?
19 A Well, they're a United Kingdom--
20 MR. BAYLY: Excuse me. I'm sorry. But I
21 have a couple of objections. First of all, the
22 witness is being asked to testify on behalf of a
0600
1 company or a personnel of a company, and I don't
2 believe he can do that. I don't believe he
3 represents them, and I don't think that's
4 specifically covered in Dr. Doblin's proffer either
5 in his prehearing statement, talking about GW's
6 reasons for not wanting to participate with Dr.
7 Doblin.
8 MS. CARPENTER: My response would be we
9 asked him what they said to him when he asked them
10 to supply the marijuana. That's what he said. I'm
11 not asking him to testify as a representative of
12 the company, but simply what they told him.
13 JUDGE BITTNER: I'll overrule that piece
14 of the objection. However, back to the prehearing
15 statement.
16 MS. CARPENTER: I believe it--
17 JUDGE BITTNER: Okay.
18 MS. CARPENTER: I think the paragraph
19 beginning one, two, three, the fourth full
20 paragraph.
21 JUDGE BITTNER: Under Dr. Doblin's
22 testimony?
0601
1 MS. CARPENTER: Yes.
2 JUDGE BITTNER: In the supplemental?
3 MS. CARPENTER: In the supplemental. As
4 Dr. Doblin testified, based on substantial evidence
5 demonstrating--
6 MR. BAYLY: I can't find it because the
7 pages aren't numbered so--
8 MS. CARPENTER: Well, it's the testimony
9 of Dr. Doblin.
10 MR. BAYLY: Right.
11 MS. CARPENTER: Fourth paragraph.
12 MR. BAYLY: Oh, okay. Starting "Unlike
13 other Schedule I drugs"?
14 MS. CARPENTER: No, starting, "As Dr.
15 Doblin will testify."
16 MR. BAYLY: Oh, okay.
17 MS. CARPENTER: Actually the paragraph at
18 the top of the page is part of the para from the
19 preceding page. "Although it stands ready to
20 sponsor research and has made arrangements for that
21 research to take place, MAPS cannot obtain the
22 cannabis it needs from the one currently existing
0602
1 cannabis provider and it cannot"--and it continues
2 to say it can't get it from other sources as well.
3 I think we did not identify GW
4 specifically. I think that's because when we wrote
5 this, I did not know about GW specifically, but it
6 certainly seems consistent with his testimony that
7 he's been unable to obtain cannabis for purposes of
8 FDA research.
9 JUDGE BITTNER: Umm--
10 MS. CARPENTER: It does list all the other
11 people that he tried to go to and couldn't get it
12 from.
13 JUDGE BITTNER: I'll sustain the objection
14 since there was no supplemental covering this.
15 MS. CARPENTER: Okay.
16 BY MS. CARPENTER:
17 Q All right. Dr. Craker, you testified
18 about this, and I just want to sort of make sure
19 that we've covered everything. Why is it that MAPS
20 needs a supply of marijuana from Dr. Craker? Did I
21 call you Dr. Craker again?
22 A Because our--
0603
1 Q Sorry.
2 A Okay. The reason we need a supply from
3 Dr. Craker is that we are engaged in trying to make
4 marijuana into an FDA-approved prescription
5 medicine, and that we need to establish a drug
6 master file for a particular product, and then we
7 need to conduct research with that product, and
8 have that product available to us for potential
9 marketing should FDA get approved.
10 We heard from Dr. Martin about, when we
11 talk about the costs of pharmaceutical drug
12 development that opportunity costs and the money is
13 a big factor, and the longer things take, the more,
14 you know, opportunity cost is incurred, and so even
15 though we're on a smaller scale, that time is
16 important, so we need a situation where we don't
17 have to wait two years to see if we can get ten
18 grams. We need immediate access once we have
19 appropriate approval from DEA and FDA for clinical
20 studies.
21 And we need to be able to select the
22 strains of marijuana that we want to research,
0604
1 which we don't have that capability with NIDA's
2 marijuana so we really need to do a realistic drug
3 development effort, and that requires our own
4 independent source of supply.
5 Q Okay. Now you've testified that you're a
6 nonprofit.
7 A Yes.
8 Q And that you're not seeking to do this for
9 profit. There were a lot of factors that Dr.
10 Martin talked about in his testimony about market
11 surveys and market size and those were things a
12 regular pharmaceutical drug company would look at
13 before it would decide to invest the money. Do you
14 feel that the source of supply is similar to that
15 in terms of it's just a matter of whether you make
16 more profit or less profit, to have a source of
17 supply over which you have control?
18 A It's not--
19 MR. BAYLY: Your Honor, I'm--wow. Is
20 there any way to break that down? It seems like a
21 multiple question and also leading, and I'm not
22 objecting.
0605
1 JUDGE BITTNER: Would you like to rephrase
2 it?
3 MS. CARPENTER: I will do that.
4 BY MS. CARPENTER:
5 Q Are you concerned about the source of
6 supply because you want to ensure that you make a
7 reasonable profit in your attempts to further
8 medical marijuana into an FDA-approved drug?
9 A Well, profit is not really our primary
10 goal, but in terms of assuming we do invest
11 millions and then get permission to market, we need
12 to be able to be assured that we would be able to
13 have a product at a reasonable price that we could
14 offer as a reasonable price. I believe that smoked
15 marijuana or vaporized marijuana in plant form will
16 successfully compete with marijuana extracts on
17 price.
18 And I believe that the efficacy and safety
19 will be similar when it's used as vaporized, and I
20 think the efficacy will be similar and safety will
21 be slightly different with smoked, but I think that
22 we do--nonprofits can have sort of profit-making
0606
1 businesses in a sense as part of their operation,
2 but that the profits don't accrue to any
3 individual, they accrue to the organization.
4 So we would need to be able to have a
5 product that we could offer that would be marketed
6 at a price that was less than people were willing
7 to pay for--I mean that our costs would be less
8 than people would be willing to pay for. So that's
9 a consideration.
10 Q Okay. And do you think you could get FDA
11 approval for your product if you don't have a
12 source of supply over which you have control?
13 A No, I don't think so. I mean I think FDA
14 wants to know exactly what you're doing research
15 with and they want to approve only the drug that
16 you did the research with. If you do research with
17 a certain drug and then you--or a certain strain of
18 a plant, and then you ask FDA to approve something
19 different, they won't do it.
20 Q Okay. And why couldn't you, if NIDA would
21 agree, if NIDA said you can use our marijuana for
22 your testing purposes, why couldn't you use that as
0607
1 your testing and then go forward, get the FDA
2 approval, see whether the FDA approves it, and then
3 move forward from there?
4 A Well, first off, I think the risk-benefit
5 ratio that FDA is going to evaluate when they look
6 at NIDA's marijuana because it's lower potency than
7 we would want to do research with and therefore
8 higher risk, I think that it automatically makes
9 our job more difficult to get FDA approval.
10 And at the same time NIDA, from my
11 understanding, NIDA is authorized by Congress to
12 pay for drugs to be produced for distribution to
13 research, but NIDA is not authorized to sell drugs
14 on a commercial basis, particularly marijuana.
15 So that we would then need to negotiate
16 not with NIDA but with Professor ElSohly. If we
17 were to use NIDA's marijuana that was produced by
18 Professor ElSohly, assuming that we would even want
19 to, assuming that we had access to it, and if FDA
20 then approved the drug on the basis of that
21 marijuana, then we would be in a position of having
22 to negotiate with Professor ElSohly, who would be
0608
1 in a monopoly position. He could charge us
2 whatever price he wanted or he could say that he
3 preferred not to sell it to us for whatever reason,
4 and then we'd be stuck.
5 So in order to justify the expenditure of
6 millions of dollars on research, really we need to
7 have certain guarantees that the marijuana, first
8 off, is what we want to use, and then secondly that
9 we would have it available, and none of that is
10 possible using NIDA's product.
11 MS. CARPENTER: Okay.
12 JUDGE BITTNER: Could I just ask, Dr.
13 Doblin, when you referred to having to negotiate
14 with Dr. ElSohly, are you saying that you would be
15 negotiating with him to provide marijuana not grown
16 under NIDA auspices? In other words--
17 THE WITNESS: Yes, that--
18 JUDGE BITTNER: --pursuant to his
19 registration with DEA as a manufacturer?
20 THE WITNESS: Yes. In fact, that's what I
21 tried to negotiate with him before for Dr. Abrams'
22 study, that he would grow specifically under
0609
1 contract to MAPS. He would have the secure
2 facilities that he was using to provide for NIDA,
3 but that we would be paying for the extra labor and
4 production costs to produce under contract to MAPS.In a
5 sense, similar to what we're asking Professor
6 Craker to do.
7 JUDGE BITTNER: Do you know whether, do
8 you know the terms of Dr. ElSohly's arrangement
9 with NIDA?
10 THE WITNESS: Well, I know the contract,
11 the request for proposals that NIDA put out, you
12 know, for him to produce certain amounts, to do
13 certain analysis. I don't know whether there's any
14 kind of any statement that he should not provide to
15 anybody else or--
16 JUDGE BITTNER: Okay.
17 THE WITNESS: So I don't know about that.
18 JUDGE BITTNER: And you don't know whether
19 there are any constraints on his DEA registration?
20 THE WITNESS: I'm not sure about that
21 either.
22 JUDGE BITTNER: Okay.
0610
1 MS. CARPENTER: Can I just ask a follow-up
2 question to that?
3 BY MS. CARPENTER:
4 Q When you were having discussions with him
5 about providing medical marijuana for Dr. Abrams'
6 study, did he indicate that there were any
7 restrictions in terms of legal restrictions on
8 whether he could do that?
9 A Well, he, at least initially, was open to
10 the idea, and so that suggested to me that if he
11 wanted to contract with us separately, that he
12 would, of course, need to speak to DEA about
13 additional production, perhaps additional quotas
14 that would need to be established for producing for
15 us, but whether theoretically he could or could not
16 produce for a private purpose other than for NIDA,
17 at least initially I got the impression that that
18 would be possible, but then he indicated to me that
19 more for political reasons he didn't want to do it.
20 Q Okay. Dr. Craker, as far as you're aware,
21 is there any--so sorry--there's a lot of doctors in
22 this courtroom. Dr. Doblin, as far as you're
0611
1 aware, is there any sort of market incentive for
2 NIDA to produce the strains or the strength of
3 marijuana that your researchers might need?
4 MR. BAYLY: Objection. Excuse me. I have
5 an objection. I'm sorry. But I just can't see
6 where this is covered, and plus if we're getting
7 into expertise issues on competition, we have the
8 same problem that we did with Dr. Craker.
9 MS. CARPENTER: I guess that's why I
10 characterize it "as far as you know." I'm
11 certainly not looking for expertise in terms of--
12 Your Honor, I guess I would say that in
13 paragraph, under Dr. Doblin's testimony, one, two,
14 three, four, five, the sixth paragraph, which
15 begins "MAPS sponsored researchers are currently
16 unable to purchase marijuana from NIDA."
17 Do you see that?
18 JUDGE BITTNER: I do.
19 MS. CARPENTER: The last sentence.
20 JUDGE BITTNER: I do.
21 MS. CARPENTER: Says "MAPS privately
22 funded therapeutic drug development effort is
0612
1 fundamentally compromised by NIDA's monopoly on
2 supply."
3 And I simply want to ask him whether he
4 thinks he has any way to effect that monopoly,
5 whether there's any market incentive that might
6 suggest that monopoly would work his way.
7 JUDGE BITTNER: Oh, that's a different
8 question. Why don't you ask that one?
9 MS. CARPENTER: Okay.
10 BY MS. CARPENTER:
11 Q Is there anything you know of that you
12 could do, Dr. Doblin, that you could offer NIDA in
13 terms of market incentive that would likely, that
14 you feel would likely allow them to provide or
15 incent them to provide you with the necessary
16 medical marijuana?
17 A Absolutely not. I've tried absolutely
18 everything that I could think of including suing
19 them and I think there's nothing that I can do to
20 make them want to provide marijuana to our studies.
21 MS. CARPENTER: Okay. All right. Your
22 Honor, I think that's all we have.
0613
1 JUDGE BITTNER: Okay. Would you like to
2 start your cross, Mr. Bayly, or would you like a
3 lunch break?
4 MR. BAYLY: Well, maybe this looks like a
5 good time to take a break.
6 JUDGE BITTNER: Okay. How did it work to
7 take an hour yesterday? Was that enough?
8 MS. CARPENTER: That was fine, Your Honor.
9 JUDGE BITTNER: Okay. I'll give you an
10 hour and three minutes. How's that for exciting?
11 MR. BAYLY: Anybody need more time? Hour
12 is okay.
13 JUDGE BITTNER: Okay. Let's resume at ten
14 minutes to one o'clock. Off the record.
15 [Whereupon, at 11:45 a.m., the hearing
16 recessed, to reconvene at 12:50 p.m., this same
17 day.]
0614
1 A F T E R N O O N S E S S I O N
2 [12:55 p.m.]
3 JUDGE BITTNER: I think we're ready for
4 cross, yes? Okay.
5 MR. BAYLY: Thank you, Judge Bittner.
6 Whereupon,
7 RICHARD DOBLIN
8 was recalled as a witness herein and, having been
9 previously duly sworn, was examined and testified
10 as follows:
11 CROSS-EXAMINATION
12 BY MR. BAYLY:
13 Q Good afternoon, Dr. Doblin.
14 A Good afternoon, Mr. Bayly.
15 Q I guess you know who I am now, so I don't
16 have to introduce myself. But I do want to ask you
17 a few questions about your testimony that you gave
18 this morning.
19 First of all, I understand that you were a
20 participant in the recent United States Supreme
21 Court decision of Gonzales v. Raich.
22 A Yes, we submitted an amicus curiae brief
0615
1 in that case.
2 Q And you submitted the brief on behalf of
3 Ms. Raich, I take it, and not on behalf of DEA,
4 correct?
5 A Yes, correct.
6 [Laughter.]
7 Q Wild guess.
8 Now, you were contending, Dr. Doblin, in
9 your amicus that the Supreme Court should allow
10 California as an internal state matter to go ahead
11 with its Proposition 215 that allows so-called
12 medical marijuana. Would that be a roughly fair
13 characterization of your position?
14 A Yes; I wouldn't have called it so-called
15 medical marijuana, but yes.
16 MR. BAYLY: Well, okay, let's talk a
17 little bit about that. I want to first present
18 everybody with a copy of another Supreme Court
19 decision. I think marijuana is unique in that it's
20 probably one of the few drugs that has been in the
21 Supreme Court more than any other drug. But I
22 would like Judge Bittner to first of all, I ask you
0616
1 to take this administrative notice. I guess we
2 normally call this judicial notice. But it's
3 Alliance for Cannabis Therapeutics, Petitioner, v.
4 DEA, and it's a 1994--actually, it's a D.C. Circuit
5 opinion. My understanding is it's the last word on
6 the Schedule 1 litigation. Well, I better not say
7 the last word.
8 MS. CARPENTER: I just have a quick
9 objection. There was no discussion of
10 reclassification or this litigation in direct, and
11 I'm not sure that it's--
12 JUDGE BITTNER: What's the purpose, Mr.
13 Bayly? Go ahead and hand it out.
14 MR. BAYLY: Yes.
15 JUDGE BITTNER: As I said it's--
16 MR. BAYLY: Well, for the purpose--one
17 purpose, Judge Bittner, is this is litigation, that
18 of course, I have to ask the witness, but I
19 understand that Dr. Doblin was involved in this
20 litigation, and it would, if nothing else, show the
21 witness' propensity, bias, what have you.
22 Secondly, this opinion does list some
0617
1 criteria in it that goes to what constitutes
2 medicine, and I think Dr. Doblin has talked about
3 marijuana in terms of the potential use for its--any medical
4 purposes. So in this regard, I think
5 it would be appropriate to ask him a few questions
6 about this and refer to these standards.
7 JUDGE BITTNER: Well, first of all, I
8 don't know that I generally take official notice of
9 cases. I mean, they're there, but I don't have any
10 objection to everyone having a copy of this
11 decision. And I think I'll stop right there and
12 see where we go.
13 MS. CARPENTER: I guess I certainly don't
14 have any objection to the Court having a case. I
15 mean, I would think that you would have the case
16 whether it's submitted or not. I guess I'm not
17 quite sure how it goes--participating in litigation
18 goes to bias.
19 JUDGE BITTNER: That may be a point to
20 argue.
21 MS. CARPENTER: Okay.
22 JUDGE BITTNER: Go ahead, Mr. Bayly.
0618
1 MR. BAYLY: You'll have to see where I go
2 here, then. Thank you.
3 BY MR. BAYLY:
4 Q Well, first of all, Dr. Doblin, do you
5 recognize this case here that you have a copy of?
6 A Yes, I wasn't directly involved in it, but
7 I recognize it.
8 Q Well, did you have an opportunity at one
9 time to be a witness on behalf of groups to place
10 marijuana into Schedule 2 from Schedule 1?
11 A I don't recall actually being a witness in
12 this case.
13 Q Okay; you don't ever recall testifying
14 back--I know I'm taking you back a long ways--but
15 back in the eighties, you don't recall testifying?
16 A Well, I was involved in the MDMA hearings,
17 the rescheduling of MDMA, and then, this was what
18 followed on with that, but I never testified before
19 an administrative law judge or anything like that.
20 JUDGE BITTNER: Did you testify in the
21 MDMA--
22 THE WITNESS: No, I coordinated the
0619
1 testimony.
2 JUDGE BITTNER: Okay.
3 THE WITNESS: But I didn't actually
4 testify myself.
5 BY MR. BAYLY:
6 Q Then, were you involved, however, in this
7 particular case, ACTS v. DEA?
8 A Well, not in any direct way, but Alliance
9 for Cannabis Therapeutics is Bob Randall's
10 organization, and I was working with Bob Randall
11 during this period of time. Prior to this,
12 actually, I worked with him on my oncology survey,
13 but I was not directly involved in this case.
14 Q Okay; were you involved in the Supreme
15 Court case that was fairly recent, the Oakland
16 Buyers Club case?
17 A We submitted--yes, I think we submitted an
18 amicus curiae brief in that case, yes.
19 Q All right; and again, that was obviously
20 not on behalf of the government but--
21 A Yes.
22 Q Now, I understand that it's your position
0620
1 that FDA should approve marijuana as medicine; I
2 mean, the herbal plant itself. Would that be
3 accurate?
4 A Well, pending sufficient data to prove
5 safety and efficacy.
6 Q Okay; Dr. Doblin, then, if you would turn
7 to the copies that we have, it looks like it would
8 be page 7.
9 A Okay.
10 Q And if you see down at the bottom, the
11 last paragraph, it says the final order discards
12 the earlier formulation and applies a new five-part
13 test for determining whether a drug is currently
14 accepted medical use. Do you see that?
15 A Yes.
16 Q Okay; and then, if I could ask you to
17 review the five factors they put under that
18 paragraph, they go from page 7 to page 8. It's
19 pretty short.
20 A Yes.
21 Q It's just like a short laundry list there.
22 A Yes, I see them.
0621
1 Q Have you had a chance to review them?
2 Take your time.
3 A Oh, yes, no, I'm aware of them, yes.
4 Q Oh, you are.
5 A Yes.
6 Q Now, would you say that the herbal plant
7 marijuana fits into any of these factors?
8 A I believe that the drug's chemistry must
9 be known and reproducible; that's factor one. I
10 think that herbal marijuana can fit with that, and
11 in fact, NIDA has a drug master file that the FDA
12 has accepted, so at least FDA believes that there
13 is a known and reproducible chemistry in the plant.
14 The FDA is trying to work with botanical medicine,
15 so I believe number one.
16 There must be adequate safety studies. I
17 think at this point, I would say that there are not
18 sufficient adequate safety studies for FDA to make
19 marijuana into a medicine. This was a lawsuit
20 trying to get the DEA to reschedule based on what
21 currently accepted medical use might mean.
22 Factor three, there must be adequate and
0622
1 well controlled studies proving efficacy. I don't
2 think that those exist yet for making marijuana
3 into a prescription medicine.
4 The drug must be accepted by qualified
5 experts. I would say there are qualified experts
6 who accept marijuana as a medicine. The scientific
7 evidence must be widely available. I think that
8 there is substantial scientific evidence that is
9 widely available; for example, you know, Sativex
10 has been approved in Canada as a medicine. But I
11 think the key factor here for me is that in order
12 to work with the FDA to get the FDA to reschedule,
13 you need additional adequate and well-controlled
14 studies and adequate safety studies.
15 Q So, then, it's your opinion that these
16 criteria are met except for number two. Would that
17 be an accurate summary of what your testimony is?
18 MS. CARPENTER: Again, I just have a quick
19 objection. I'm not sure what the relevance of this
20 is. These are factors that relate to
21 reclassification, which is not an issue before the
22 Court, nor was it something testified to on direct.
0623
1 MR. BAYLY: The witness did talk about
2 having marijuana become an FDA approved medicine on
3 direct, definitely, and in addition, I think we
4 need to look into this as much as the witness has
5 indicated that he has supported the Raich v.
6 Gonzales litigation and in so doing has supported
7 having herbal marijuana as allowable as a medicine.
8 MS. CARPENTER: Well, let me just respond
9 to that. First of all, the issue before Raich v.
10 Gonzales was not whether or not herbal marijuana
11 would be available as a medicine but whether there
12 was interstate commerce involved in the particular
13 marijuana involved in that case. So that's not
14 really on point.
15 MR. BAYLY: That's not what the amicus
16 brief said, no.
17 JUDGE BITTNER: But I haven't read the
18 amicus brief, and I'd much rather not.
19 [Laughter.]
20 JUDGE BITTNER: I'm sure it's beautifully
21 worded but--okay, Ms. Carpenter, you have a point.
22 MS. CARPENTER: And the second point,
0624
1 again, is that what's referred to in this case are
2 the classification, these criteria for
3 reclassifying marijuana into a Schedule 2 from
4 Schedule 1, which is not what the FDA requires in
5 order to have something become an FDA-approved
6 medicine.
7 JUDGE BITTNER: Okay.
8 MS. CARPENTER: So I think it's just not
9 relevant.
10 JUDGE BITTNER: Okay; see if I can work my
11 way through the thicket here or whatever it is,
12 swamp, thicket, woods.
13 [Laughter.]
14 JUDGE BITTNER: As I said Monday, I think,
15 this case is not about whether marijuana has a
16 medical use, and we are not relitigating the
17 rescheduling cases, which I remember. That's what
18 we're not doing. What this case is about is, as
19 far as I'm concerned, anyway, is whether or not Dr.
20 Craker shows that his application to manufacture,
21 cultivate marijuana meets the criteria of 21 U.S.C.
22 Section 823(a).
0625
1 Now, having said that, inasmuch as the
2 evidence we have so far indicates that Dr. Craker
3 would be working with MAPS, and the researchers to
4 whom Dr. Craker would provide the marijuana if he
5 had the registration to grow it would be brought to
6 him by MAPS, I think there is some relevance to
7 what MAPS intends to do with this research if it
8 ever gets it, gets the research.
9 So to that extent, I will--and I'm not
10 sure whether there can be a prescription drug made
11 from a Schedule 1 substance. I'd be kind of
12 surprised, but I've been surprised by a lot of
13 things, so that means absolutely nothing. But I
14 think that Dr. Doblin's testimony as to how these
15 factors, these criteria that are listed by the
16 court would work into what MAPS intends to do is
17 probably relevant. So I'll overrule the objection.
18 But I don't want to get down the medical marijuana
19 road, okay?
20 So do either of you remember what the
21 question was?
22 THE WITNESS: Yes; you were asking whether
0626
1 I thought factor two was the only factor that
2 really hadn't been met yet. I think that's what
3 you were asking.
4 BY MR. BAYLY:
5 Q Right.
6 A And factor two is there must be adequate
7 safety studies. And I think that that has not been
8 met yet, nor do I think that factor three has been
9 met, adequate and well controlled studies.
10 I'm not sure if it's appropriate for me to
11 address what you just said, but several Schedule 1
12 drugs have been made into prescription medicines,
13 including THC.
14 Q I think I can walk you through that, Dr.
15 Doblin.
16 JUDGE BITTNER: All right; okay. Got it.
17 THE WITNESS: Okay.
18 BY MR. BAYLY:
19 Q I think other witnesses may go into this,
20 but you can explain how, potentially, a Schedule 1
21 could get into a lower schedule. What's the
22 process?
0627
1 A Well, the process is to conduct these
2 adequate and well controlled studies, both into
3 safety and efficacy, and then convince the FDA that
4 indeed, you've demonstrated a balance of safety and
5 efficacy that suggests that they should be
6 approved. If FDA decides to approve a Schedule 1
7 drug as a prescription medicine, then, DEA has to
8 decide should it be Schedule 2, should it be
9 Schedule 3, which schedule does it go in.
10 But once FDA decides that a drug has been
11 demonstrated to be efficacious for a particular
12 indication, then, it will be made available as a
13 medicine, and then, in which schedule and how it is
14 controlled is more to the purview of DEA.
15 Q Is that what happened with dronabinol?
16 A Yes, I think so.
17 MR. BAYLY: Your Honor, I'd like to have
18 Dr. Doblin be shown Exhibit No. 24. It's
19 Respondent Exhibit No. 24.
20 JUDGE BITTNER: Okay.
21 THE WITNESS: This is the American Medical
22 Association document; is that it?
0628
1 BY MR. BAYLY:
2 Q That is correct.
3 A Okay.
4 Q I want to refer you, Dr. Doblin, it
5 appears you already have it up there, the exhibit,
6 and it's page 4. It says the pharmacology of
7 marijuana.
8 A Yes.
9 Q And I want to refer you just to the very
10 first sentence below that. I will read it without
11 trying to slaughter some of these pronunciations
12 too much. Quote, marijuana contains more than 400
13 chemical compounds. The main psychoactive
14 substance is generally believed to be delta-9-
15 tetrahydrocannabinol and at least 60 other
16 cannabinoids, C-21 containing compounds having been
17 identified in the pyrolysis products.
18 First of all, and I'm not even sure I'm
19 pronouncing this right, but pyrolysis--
20 A Pyrolysis.
21 Q That's burning right?
22 A Pyrolysis, that's burning, yes.
0629
1 Q Burning, okay. I told you I'd slaughter
2 the pronunciation of some these. But anyway, okay,
3 do you agree with what's in there?
4 A I'm not a chemist, but I would believe
5 that there probably are 400 chemical compounds and
6 that there may be 60 other--I think it would differ
7 depending on the strains, but what I believe the
8 FDA looks at is primarily the main active
9 ingredients. And the FDA has developed guidelines
10 for developing botanical products that also have
11 similar amounts of chemicals.
12 When you look at what is in various other
13 plants, St. John's Wort, other chemicals that have
14 been used or other plants that have been researched
15 for depression and other things, so the FDA clearly
16 is capable of making a botanical product into a
17 prescription medicine.
18 Q Yes, but as it stands now, Dr. Doblin,
19 given this information that we're going to take on
20 face value in Respondent Exhibit No. 24, would you
21 still agree that the drugs, i.e., marijuana's
22 chemistry is known and reproducible?
0630
1 A It sounds like it's pretty known right
2 here. That's what they're saying. If they know
3 that there are 400 chemical compounds and I think
4 that you can produce through cloned plants, you can
5 reproduce the same chemical composition in a plant
6 over and over and over and make it standardized and
7 make it available as a prescription medicine. So I
8 believe that it s definitely possible to make
9 plants into prescription medicines and specifically
10 the marijuana plant.
11 Q Right; but you don't actually know what
12 all of these constituents will actually do, how
13 they will affect a person.
14 A Well, in a sense, you do, because what the
15 FDA has said is that you can assess safety from a
16 plant as a whole. As long as you have a
17 standardized product, you don't need to do safety
18 studies on each of these 400 compounds. You don't
19 need to do efficacy studies on each of these 60
20 cannabinoids, but you can assess safety and
21 efficacy with the plant as a whole and that the FDA
22 will ask you to standardize--probably what the FDA
0631
1 would do with marijuana is--what the FDA does with
2 NIDA's marijuana is only on the THC.
3 They ask that the THC content be
4 consistent. You know, it may be possible that they
5 would become more sophisticated and say we would
6 like the THC and the CBD to be consistent from each
7 plant product to make sure that it is standardized.
8 But I think that this is not a barrier to making
9 marijuana into a prescription medicine, nor do I
10 believe that the FDA would say that there is an
11 inherent barrier.
12 Q Well, all right, would your position now,
13 however, be changed and the position that you took
14 in Gonzales v. Raich in light of your testimony
15 that you don't feel there are adequate safety
16 studies yet for marijuana?
17 A My position in Gonzales-Raich was that
18 when the Supreme Court makes the decision about
19 whether or not to permit the State of California
20 and other states to make marijuana available to
21 patients, it should be aware that the standard
22 route, the appropriate route, the way that our
0632
1 society has decided to evaluate medicines is to
2 take things through the FDA and that the FDA system
3 was fundamentally obstructed as a result of NIDA's
4 monopoly.
5 So the Supreme Court should take that into
6 consideration when they evaluate the legal
7 arguments about interstate commerce. Our amicus
8 curiae brief didn't say anything about interstate
9 commerce. What I had hoped would happen is that
10 the Supreme Court would acknowledge the fact that
11 there had been a fundamental obstruction of the FDA
12 process and at least take note of that, maybe
13 encourage DEA to license Professor Craker's
14 facility. That was my intention of submitting that
15 amicus curiae brief.
16 Q But wasn't your intent, then, to also, if
17 your intent, if you had prevailed in your position,
18 then, the result would have been that at least in
19 California and perhaps in the other states that
20 have legalized marijuana, then, it would be
21 available solely within the state as medicine for
22 people that wanted it.
0633
1 A If the Supreme Court would have decided
2 that that was the case, yes, that would have been
3 the outcome.
4 Q But the Supreme Court wasn't deciding the
5 safety of the marijuana, then, were they?
6 A No, they were just deciding this
7 interstate commerce issue.
8 Q But you would agree, though, that no
9 matter what they decided in Raich v. Gonzales that
10 marijuana should not be available at this point for
11 medicine.
12 A No, I wouldn't agree with that, no.
13 Should--no, I think that--
14 JUDGE BITTNER: I'm not sure what the
15 question was. Would you repeat the question, Mr.
16 Bayly?
17 BY MR. BAYLY:
18 Q You would agree that marijuana, under the
19 existing circumstances now, should not be available
20 for medical use for patients.
21 A Well, as I'm sure you'll probably ask me
22 later, I believe that the system of prohibition
0634
1 that we have is counterproductive and that
2 marijuana should be a legal substance for both
3 medical and nonmedical purposes. That's my
4 personal belief. I believe that in order to work
5 with making it into a medicine that working through
6 the FDA is the appropriate way to go.
7 Q And until and unless that happens, you
8 would agree that marijuana should not be used by
9 patients.
10 A No, I would not agree. I would agree that
11 for the last 30 years, research has been blocked,
12 and I think the Government should be penalized for
13 blocking medical marijuana research for 30 years.
14 Q But what about the safety of the people,
15 Dr. Doblin, that are using this now?
16 A I think that's--right now, I think that
17 the way it was in the State of California and other
18 states, that's a decision that doctors make in
19 conjunction with their patients. I don't think
20 that's ideal. I don't think that that's ideal. I
21 think that the fact that as far as I can tell,
22 roughly $15 million has been spent on these state
0635
1 medical marijuana initiatives. I think that's
2 incredibly socially wasteful. I think that that
3 money should have gone into research so that we
4 would get these answers.
5 But since the research has been blocked,
6 patients face life and death decisions today, and I
7 think that the doctors and patients in the absence
8 of an open field to do the research are left with
9 some difficult decisions, and I would rather those
10 decisions be made by doctors and patients rather
11 than by police.
12 Q And that's your opinion, as a policy
13 matter, you would rather--it's like a cost-benefit
14 analysis, then? In other words, would like to have
15 the doctors and the patients circumvent any FDA
16 approval of marijuana as--
17 A I think there is no FDA approval process
18 that's permitted right now. CMCR is not making
19 marijuana into a prescription medicine; we are
20 blocked from even buying 10 grams to do vaporizer
21 research. So I think that our society has set up
22 the FDA as the proper venue to evaluate medicines,
0636
1 and I fully support that. And I just wish that we
2 could go through the FDA with marijuana. And
3 that's what this whole application for Professor
4 Craker is about.
5 I want to take this through the FDA and
6 evaluate under scientific conditions what are the
7 safety issues, what are the efficacy potentials,
8 and I'm fully supportive of the FDA process. But I
9 don't think there is a fair avenue to do the
10 necessary research.
11 Q So the answer to my question would be yes.
12 A Well, could you restate your question?
13 MS. CARPENTER: Objection; he's answered
14 the question fully.
15 JUDGE BITTNER: Actually, no, I don't
16 think that was the answer.
17 [Laughter.]
18 MR. BAYLY: Well, then, maybe I better try
19 it again.
20 [Laughter.]
21 BY MR. BAYLY:
22 Q So in other words, because the FDA for
0637
1 whatever reasons you believe has not been able to
2 do the safety study on marijuana, you believe that
3 it should be available to patients for medical use
4 pending FDA's safety studies.
5 A I think that doctors and patients should
6 have the right at this stage to decide on whether
7 they should be able to use--whether the patients
8 should use marijuana. But I feel that that is a
9 fallback position. That's not the ideal approach.
10 The ideal approach and the one that I've been
11 trying fruitlessly to pursue for a long time is to
12 move marijuana through the FDA drug development
13 process and then really see what conditions does it
14 help, what conditions does it not help, how much of
15 it is the placebo effect, how many side effects
16 there are.
17 So because, I think, the Government has
18 blocked the research, I think that patients and
19 their doctors facing serious illnesses should have
20 the right to decide for themselves whether to use
21 marijuana for medical purposes.
22 Q Well, do you recognize, though, that
0638
1 marijuana is also a drug that has a high potential
2 for abuse?
3 A Yes.
4 Q And do you agree that marijuana should not
5 be used for recreational purposes because of its
6 high potential for abuse?
7 MS. CARPENTER: Objection to the relevance
8 of the question. I'm not sure why his personal
9 opinion is relevant.
10 MR. BAYLY: Well, this definitely goes to
11 bias, Judge Bittner.
12 JUDGE BITTNER: Well, I'm not sure that
13 the witness' bias--I mean, the witness is a party
14 in interest in the litigation, so presumably, he's
15 got a bias. But in light of his earlier testimony,
16 I'll overrule the objection.
17 THE WITNESS: I believe that individuals
18 should have, adults should have the right to decide
19 for themselves whether they would like to use
20 marijuana or not and that they should pay taxes on
21 the purchase of it and that--I believe that
22 prohibition is counterproductive to reducing drug
0639
1 abuse. I believe that there is a high potential
2 for abuse of marijuana, and I don't think the
3 current system really does a lot to reduce
4 substantially the abuse of it and creates
5 additional problems.
6 So I think on balance, our society would
7 be better off. We would have less drug abuse, less
8 crime of certain types if we had marijuana as a
9 legally available substance.
10 BY MR. BAYLY:
11 Q All right; so just so I'm clear in your
12 answer, Dr. Doblin, you believe that a citizen
13 should have the right to use marijuana even if
14 there's no medical justification for it.
15 A Well, yes, similar to alcohol, similar to
16 tobacco, similar to coffee, similar to sugar, yes.
17 Q But at this point, you don't consider
18 smoked marijuana to be medicine.
19 A I consider smoked marijuana to be
20 medicine, yes, I do.
21 Q Let me draw your attention, Dr. Doblin, to
22 the IOM report. That's what I call it. It's
0640
1 Respondent Exhibit No. 1.
2 A I have it now.
3 MR. BAYLY: If I could have you please
4 turn to page 233, Dr. Doblin.
5 JUDGE BITTNER: That's the Bates stamp
6 233?
7 MR. BAYLY: Yes, right.
8 BY MR. BAYLY:
9 Q I may have misnumbered some of these. I
10 hope not. But I'm trying to stick with the Bates
11 stamps on the bottom center of the page.
12 A Yes, I see it.
13 Q And this is out of Chapter 5, Respondent
14 Exhibit No. 1, the IOM report. You will see the
15 subheading there, regulatory hurdles to market,
16 almost in the middle of the page.
17 A Yes, I see it.
18 Q And if you go down three paragraphs--
19 A Yes.
20 Q I want to ask you to--well, let me read
21 this sentence, and then, I will ask you a question
22 about it. Quote, bringing marijuana to market as a
0641
1 new drug is uncharted terrain. The route is
2 fraught with uncertainty for at least three
3 pharmacological reasons: marijuana is a botanical
4 product; it is smoked; and it is a drug with abuse
5 potential.
6 Do you agree with that statement?
7 A Yes, I think that--I would say, though,
8 that the uncertainty as far as marijuana being a
9 botanical product has been reduced. Last year, FDA
10 put out a guidance for the development of botanical
11 products as medicines. So I think it's no longer
12 as uncertain how to develop a botanical product.
13 I think the fact that it's smoked is
14 interesting, and it's an issue, but vaporization is
15 not the same as smoking, and so, since the IOM
16 report has come out and recommended nonsmoking
17 delivery systems, it's not inherently the case that
18 marijuana must be smoked as a medicine. And I
19 certainly agree that it has abuse potential.
20 Q All right; and Dr. Doblin, the next
21 sentence, then, quote: in general, botanical
22 products are inherently more difficult to bring to
0642
1 market than are single-chemical entities, because
2 they are complex mixtures of active and inactive
3 ingredients. Do you agree with that?
4 A Yes, I do.
5 Q And certainly, marijuana would be
6 considered one of those botanical products, would
7 it not?
8 A Yes, it would.
9 Q And if you would please turn now, flip
10 over to 235, I apologize; we're going to be
11 flipping around a little bit here, but next
12 statement: if you look under market outlook, that
13 subtitle.
14 A Yes, I see it.
15 Q In the middle of the page.
16 A Yes.
17 Q And I think we're on the third or fourth
18 sentence; let me quote it, and I'll make sure that
19 you find it there. Quote, further scientific
20 hurdles are related to satisfying the exacting
21 requirements for FDA approval of a new drug. The
22 hurdles are even more exacting for a botanical
0643
1 product because of the inherent problems with, for
2 example, purity and consistency.
3 Do you agree with that statement?
4 A I agree with it, but I would also point
5 out that GW Pharmaceuticals has a botanical extract
6 that's from the plant that's been accepted in
7 Canada and approved as a prescription medicine. So
8 I don't think the fact that marijuana is a
9 botanical product inherently means that you can't
10 demonstrate purity, consistency, and anything else
11 that the FDA would require of it.
12 Q Are you aware--you're talking about
13 Sativex, right?
14 A Sativex, right.
15 Q And that is S-A-T-I-V-E-X.
16 A Yes, yes, that's it.
17 Q I know the court reporter will appreciate
18 that. And that is now on the market in Canada, as
19 you pointed out; is that correct?
20 A Yes.
21 Q Is that even under consideration to be
22 marketed in the United States at this time?
0644
1 A It is my understanding that GW
2 Pharmaceuticals intends at some point to try to
3 bring it to market in the United States. I think
4 it's certainly not yet approved in the United
5 States. I believe that they're going to try to get
6 it approved in England, and then, they're going to
7 start trying to move to the United States.
8 Q And if they move to the United States,
9 where would they get their supply of marijuana?
10 A They grow it themselves. They have
11 permission to--
12 Q Import it.
13 A They would import it from their production
14 in England.
15 JUDGE BITTNER: I am confused. Would it
16 be produced in the United States, or would it be
17 produced in England and exported to the U.S.
18 THE WITNESS: Well, again, that would be a
19 decision that they would make.
20 JUDGE BITTNER: Right.
21 THE WITNESS: Right now, their only
22 production facility is in England. If they get it
0645
1 approved by the FDA, they might then go to DEA and
2 ask for permission to grow it here as well. I
3 don't know that the shipping costs are all that
4 substantial, so that they would need a separate
5 plant here with all the security. I'm not sure
6 what their economic decisions would be, but they
7 may indeed decide to try to grow it here as well if
8 they get it approved by the FDA.
9 BY MR. BAYLY:
10 Q Well, do you have any reason to believe
11 that if FDA, if they did get it approved by FDA to
12 market that DEA would block the rescheduling of it?
13 A My feeling, I don't know for sure, but I
14 would imagine that if FDA--if FDA approves a drug
15 as a medicine, DEA must reschedule out of Schedule
16 1. The only decision that DEA has to make is what
17 schedule to put it in. But shifting from 1 to 2
18 means that there is a currently accepted medical
19 use, and we all agree that FDA can determine if
20 there is a currently accepted medical use.
21 Q All right; Dr. Doblin, going back to the
22 statement here, further scientific hurdles are
0646
1 related to satisfying the exacting requirements for
2 FDA approval of a new drug, and the hurdles are
3 even more existing for a botanical product because
4 of the inherent problems.
5 A Right.
6 Q For example, purity and consistency. Is
7 that something that you believe a pharmaceutical
8 company would take into consideration when they're
9 looking to develop a possible medicinal use for
10 marijuana?
11 A Well, MAPS is a pharmaceutical company,
12 and we do take these things into consideration.
13 And I'm sure that other pharmaceutical companies
14 would take all of these factors into consideration,
15 and I'm sure that GW Pharmaceuticals took this into
16 consideration.
17 Q Well, when you say MAPS is a
18 pharmaceutical company, you don't mean that you
19 actually have facilities to process drugs and make
20 drugs and manufacture them.
21 A Well, that's actually not a necessary
22 requirement to be a pharmaceutical company. We
0647
1 contract with manufacturers to manufacture
2 psilocybin, MDMA. We hope to obtain permission
3 from FDA to market those drugs as prescription
4 medicines. At some point, we may, if we ever do
5 get permission, decide to create our own facilities
6 with DEA licenses to produce.
7 So we hope eventually that Professor
8 Craker would grow for research, and if the research
9 pans out, that that facility would be expanded to
10 provide for prescription use. So we are a
11 pharmaceutical company without a marketable
12 product. We are a pharmaceutical company that is
13 trying to work through the FDA to develop a
14 pharmaceutical product. There's a lot of
15 pharmaceutical companies that don't have products
16 yet that are approved for marketing.
17 Q Yes, but you are looking for a
18 pharmaceutical company to develop this product if
19 it is approved, right?
20 A No, no.
21 Q You're not going to do it yourself, right?
22 A No, no, MAPS would do it ourselves. We
0648
1 are sponsoring the MDMA research. We're sponsoring
2 the psilocybin research. We are acting as a
3 nonprofit pharmaceutical company, and we would like
4 to be at the other end of the process engaged in
5 actually marketing for prescription use.
6 Q Now, you say you've sponsored other drugs
7 like MDMA.
8 A Right.
9 Q If MDMA is approved as a--let's say it's
10 approved for Schedule 2, so it's approved for some
11 kind of medical use.
12 A Okay.
13 Q Is MAPS, then, prepared to actually launch
14 the product, produce the product and launch it into
15 the market?
16 A Yes, that's our explicit goal. That is
17 our mission statement.
18 Q And MAPS, then, is prepared to obtain a
19 DEA registration as the manufacturer of a Schedule
20 2 product.
21 A Well, that is an economic decision,
22 whether we would try to produce it in house or
0649
1 contract with people who already have DEA licenses
2 to manufacture it. So it's not clear to me whether
3 we would choose to try to produce it ourselves or
4 whether we would contract out to somebody else to
5 manufacture. But we would be the company that
6 would market it for prescription use. That's the
7 goal, yes.
8 Q Well, but I'm not talking about marketing,
9 though, Dr. Doblin. I'm talking about the actual
10 production of the medicine itself, be it in pill
11 form or what have you.
12 A It's entirely possible that we would work
13 with DEA to set up some sort of secure facility
14 with people that you would trust to be in charge of
15 that facility to manufacture and that they would be
16 part of MAPS. Nonprofits can manufacture drugs;
17 can have profit making components. We might spin
18 it off to some other company and then use the funds
19 for additional research with additional substances.
20 But it's definitely our goal to try to
21 get, to fund the research, to get the data to FDA
22 for them to decide whether MDMA and marijuana
0650
1 should be approved as prescription medicines. And
2 then, if we do that, FDA is then looking to us to
3 provide the substance for prescription use. And
4 whether we produce it in house or contract with a
5 firm to do it, that's a decision for a later time.
6 Q But, okay, so right now, you don't have
7 any imminent plans to build a production facility
8 to make any kind of medicine from Schedule 1 drugs
9 that are rescheduled to a lower schedule.
10 A We have no plans like that. I mean, we're
11 years away from getting sufficient data and doing
12 the Phase Three studies. I'm anticipating that
13 it's roughly a $5 million, five-year process to do
14 the research to make MDMA into a prescription
15 medicine.
16 Q All right; and that's just for the
17 research, then.
18 A That's just for the research, yes. And it
19 could be $5 million to $10 million, in that range,
20 but it's certainly not out of our ability to raise
21 the funds and sponsor the research.
22 Q Okay; if I could ask you, please, to flip
0651
1 back to 233.
2 A Okay.
3 Q I'm sorry for having you flip around, but
4 let's just bear with me here and let me read the
5 quote from page 233. I think it's in the same
6 paragraph that we referred to about the third
7 paragraph down from--
8 A Okay.
9 Q --under the subheading regulatory hurdles
10 to market.
11 It says, quote, concerns arise about
12 product consistency, potency of the active
13 ingredients, contamination and stability of both
14 active and inactive ingredients over time. These
15 are among the concerns that a sponsor would have to
16 overcome to meet requirements for an NDA,
17 especially those related to safety and to chemistry
18 manufacturing and control.
19 Would you agree with that statement, Dr.
20 Doblin?
21 A I would agree with it and say that it's
22 actually more rigorous than they're saying, because
0652
1 you need to establish these things for an IND.
2 Just to do the research prior to even getting a new
3 drug approval, you have to satisfy to the FDA that
4 you have a consistent product, that you have a
5 product that's not contaminated.
6 So while this is all true with an NDA,
7 it's true even earlier in the process just to do
8 your first research studies, and that's what NIDA
9 has done with Dr. ElSohly. They have developed
10 marijuana to the point where the FDA is convinced
11 that there is a certain product consistency, that
12 they know the potency of the active ingredients;
13 it's not contaminated and that it's stable over
14 time, more or less.
15 Q You're talking about Dr. ElSohly's
16 marijuana that's obtained through NIDA by the
17 researchers.
18 A Yes, yes. FDA wouldn't permit the studies
19 to take place unless NIDA had a drug master file
20 that satisfied FDA that these conditions were met
21 just to do the research.
22 Q Okay; but that doesn't necessarily
0653
1 translate to the fact that this marijuana is
2 medicine.
3 A Just doing research doesn't mean that
4 something is a medicine. I mean, getting something
5 in research just means that the FDA has decided
6 that at this point of the scientific uncertainty
7 that the safety factors are not so much that the
8 research shouldn't be done and that the research is
9 designed to evaluate whether something should
10 become a medicine.
11 Q All right; let's turn all the way back to
12 page--I think it's 22 of Government Exhibit No. 1.
13 JUDGE BITTNER: Government or Respondent.
14 MR. BAYLY: I'm sorry; Respondent.
15 THE WITNESS: Okay.
16 BY MR. BAYLY:
17 Q This is the executive summary, Dr. Doblin.
18 A Okay.
19 Q It's the first full paragraph, and let me
20 quote it to you: defined substances such as
21 purified cannabinoid compounds are preferable to
22 plant products which are variable and of uncertain
0654
1 composition. Use of defined cannabinoids permits a
2 more precise evaluation of their effects, whether
3 in combination or alone. Medications that can
4 maximize the desired effects of cannabinoids and
5 minimize the undesirable effects can very likely be
6 identified. Do you agree with those statements?
7 A I'm quite reluctant to disagree with the
8 Institute of Medicine and the National Academy of
9 Sciences, but in this case, I do disagree. For
10 example, CBD is an antianxiety agent, and the
11 combination of THC and CBD in the plant acts to
12 reduce some anxiety. And so, the isolated
13 cannabinoid in Marinol is more likely to produce
14 anxiety reactions than smoked marijuana.
15 So I think preferred by whom? There is
16 more and more of a development towards acceptance
17 of botanical medicines that have a synergistic
18 effect of the various ingredients. So while
19 pharmaceutical companies frequently prefer the
20 isolated ingredients, which they can patent, that's
21 not the only kind of medicine.
22 Other people prefer to take medicines in
0655
1 plant forms. Usually, plants are less toxic in
2 some ways. The ingredients are moderated by other
3 ingredients in the plant. So I would say that it's
4 not inherently true that always, you prefer an
5 isolated substance to the plant form itself.
6 Q All right; let me take you to page 21 and
7 the next to the last sentence. The effects of
8 cannabinoids on the systems studies are generally
9 modest. In most cases, there are more effective
10 medications. Do you agree with that?
11 A I don't know that I would agree with that
12 either; for example, for nausea control for cancer
13 chemotherapy, sometimes, marijuana seems to work
14 where other medications don't work. And it's not
15 modest; it's substantial. For appetite
16 stimulation, for AIDS wasting, many people report
17 that it's not modest at all. For pain control,
18 sometimes, marijuana seems to work where other
19 medications don't.
20 I think that we will see how to evaluate
21 this statement once some of the CMCR Phase Two
22 studies get published. And frequently, in order to
0656
1 do research, you have to work with--with drugs that
2 are considered to have a high potential for abuse,
3 a lot of times, the clinical studies are designed
4 to work with treatment failures, with people who
5 have failed on other medications; then, they get
6 enrolled in these studies.
7 So I think that there are subpopulations
8 of people for whom the effect of marijuana is not
9 modest, and I think in many cases, there are not
10 more effective medications.
11 Q Well, Dr. Doblin, doesn't the IOM study
12 tend to lead more toward the cannabinoids as a
13 potential medicine as opposed to the plant material
14 itself?
15 A Yes.
16 MR. BAYLY: Your Honor, may we take a
17 short break?
18 JUDGE BITTNER: Mm-hmm. Ten minutes?
19 MR. BAYLY: Sure.
20 JUDGE BITTNER: Off the record.
21 [Recess.]
22 MR. BAYLY: Thank you, Judge Bittner. I
0657
1 would like the witness to be handed--is it
2 Respondent 52? July 27 letter, 2005? HHS to
3 Mister--yes, the whole exhibit.
4 THE WITNESS: I have it.
5 BY MR. BAYLY:
6 Q Dr. Doblin, the letter you now have is the
7 denial of the protocol of Chemic by NIDA; is that
8 correct?
9 A Yes, it is.
10 Q Now, how long have you been with MAPS?
11 How long do you go back with them?
12 A Well, I started MAPS in 1986.
13 Q And the Chemic study with a water pipe and
14 vaporizer goes back quite a long ways, didn't it?
15 A Well, Chemic didn't initially do the water
16 pipe study. That was with the American Health
17 Foundation in New York. So that was with a
18 different company, but yes, it does go way back.
19 Q And in fact, back in 1994, actually, NIDA
20 agreed to provide marijuana to MAPS for a water
21 pipe and vaporizer study; is that correct?
22 A Yes, that's true.
0658
1 MS. CARPENTER: I'm sorry; what was the
2 date on that that you said?
3 MR. BAYLY: 1994.
4 MS. CARPENTER: Four; thank you.
5 BY MR. BAYLY:
6 Q Now, you see that Government--or
7 Respondent Exhibit No. 52 up there is the denial by
8 NIDA. Is there anything in the exhibits that
9 you're aware of where FDA has approved Chemic's
10 protocol here, or is FDA approval not necessary?
11 A FDA approval is not necessary, because
12 this doesn't involve human subjects.
13 Q So the only game in town is NIDA to
14 approve it or not.
15 A Because NIDA has a monopoly on the supply,
16 we need to go to NIDA for the material to do the
17 study at this point, yes.
18 Q Well, now, Chemic is hoping if it gets a
19 protocol approved to get marijuana from NIDA and
20 import it from Holland; is that the plan?
21 A Yes, yes.
22 Q Now, Chemic certainly can resubmit its
0659
1 protocol, can it not?
2 A Well, my belief is that Chemic is not
3 going to resubmit the protocol. They are going to
4 respond to the allegations of NIDA that it was not
5 scientifically meritorious, and they intend to
6 argue that there is a series of mistakes,
7 misunderstandings, misreadings and that the
8 protocol is indeed scientifically meritorious. So
9 at this stage, they do not intend to redesign the
10 protocol. They intend to challenge the claim that
11 it's not scientifically meritorious.
12 Q When you say challenge, are you talking
13 about going into court or just going back to NIDA
14 and saying let's see if we can work this out?
15 A Well, that depends on how long it takes to
16 get a response. This took us two years to get a
17 response to the protocol, whether it was
18 scientifically meritorious or not according to NIDA
19 and HHS, so that if they submit their reply, which
20 I anticipate will be submitted within the next
21 couple of weeks, and then, NIDA and HHS respond
22 within a reasonable amount of time, which I would
0660
1 interpret to be, you know, a couple of weeks or a
2 month, you know, then, we have no intention of
3 going to court.
4 That was only after 16 months that we
5 didn't get an answer that we felt that it was
6 necessary to file a lawsuit.
7 Q All right; but there is still the
8 possibility that this protocol can be approved.
9 A Yes, I certainly think that once Joel
10 Egertson reads the reply from Chemic that he will
11 realize that some of these critiques were not
12 appropriate, were misunderstandings and that this
13 protocol should be approved as written.
14 Q In your opinion.
15 A In my opinion.
16 Q Now, the protocol, Dr. Doblin, actually is
17 not NIDA, per se; it's the Public Health Service,
18 PHS.
19 A Yes, it is a combination of NIDA and the
20 Public Health Service. As Nora Volkow said, NIDA
21 is only one of the agencies involved in reviewing
22 the protocol.
0661
1 Q And I think if the PHS doesn't review the
2 protocol, then, no one else will. I mean, no one
3 else has a legal obligation to do that; is that
4 correct?
5 A Right, right; FDA doesn't need to. DEA
6 still needs to make sure that Chemic has the
7 necessary licenses, but in terms of reviewing the
8 protocol, that's the Public Health Service.
9 Q All right; but the bottom line is, Dr.
10 Doblin, you would agree with me that there is
11 nothing DEA can do in terms of Chemic's
12 application. Well, let me back up here. Chemic
13 has filed an application as a researcher; is that
14 correct? Is that your understanding?
15 A Well, yes, Chemic has applied to DEA for
16 the importation.
17 Q But in order to import as well as to get
18 the marijuana through NIDA and the PHS, they would
19 need to get this research application.
20 A I think it's DEA's discretion, in a sense,
21 what it decides, how to evaluate an application to
22 import.
0662
1 Q Right, but an import application is
2 contingent on a proper registration with DEA as a
3 precondition to import; is that correct?
4 A Yes, yes.
5 JUDGE BITTNER: Chemic doesn't hold a
6 researcher registration now for Schedule 1?
7 THE WITNESS: That's very interesting.
8 That's a whole other story. Chemic was approached--Chemic
9 has an analytical license that they--you
10 know, they're a 40-person firm. They do all sorts
11 of analytical work. And to my understanding, DEA
12 went to them and said that they need an additional
13 license as a researcher, which they have applied
14 for quite a few months ago.
15 From what I understand, the security
16 arrangements, all of the things that would be used
17 to evaluate whether to give a research license are
18 the same as whether to give an analytical lab
19 license. And so, Chemic is waiting to receive this
20 research license from DEA and has been waiting
21 quite a long time, longer than they expected to
22 wait.
0663
1 I think DEA has sent out inspectors again
2 quite a long time ago. So Chemic believes that it
3 can get the necessary licenses from DEA to do this
4 research.
5 BY MR. BAYLY:
6 Q So Chemic's application for a researcher
7 is pending.
8 A Yes, you would probably know more about
9 that than I do, but, I mean, it's pending. I'm not
10 sure where it is in the process.
11 Q Well, all right, but at least to your
12 knowledge, have they submitted an application to be
13 a researcher?
14 A They submitted it immediately after they
15 were told by DEA that their analytical laboratory
16 license needed to be supplemented by a research
17 license.
18 Q All right; and then, the researcher
19 application is contingent upon getting the NIDA
20 marijuana, for one; is that correct?
21 A Well, we could go forward with the
22 imported marijuana to do a portion of this study.
0664
1 We want to compare both.
2 Q But isn't the purpose of the study is to
3 compare the two, the NIDA and the Dutch marijuana?
4 A In part, it is to compare the two. The
5 Dutch marijuana is high in CBD, a variety that NIDA
6 doesn't have available. But also, part of it is to
7 evaluate the vaporizer to see how consistent it is
8 in terms of every time you use it, is it
9 consistent. And so, they could go forward with the
10 portion of the study that would be with the
11 imported marijuana prior to actually having the
12 marijuana from NIDA.
13 Q All right; but your understanding, though,
14 is that DEA doesn't have any authority to indicate
15 to NIDA or PHS to whom to give marijuana; is that
16 correct?
17 A Right; I think that is a decision to be
18 made by the Public Health Service and NIDA.
19 Q Right; that's not DEA.
20 A Right, I think DEA is limited to the
21 importation issue.
22 Q And even if Dr. Craker got registered,
0665
1 that doesn't affect Chemic's denial here.
2 A Oh, it completely does, because marijuana
3 is the only drug for which the Public Health
4 Service reviews protocols when you're seeking to
5 purchase them yourself. When you want a government
6 grant, naturally, the government will review
7 protocols for any drug. However, when you're going
8 to pay for the studies yourself, and if you have
9 the source of supply--for example, if we had Dr.
10 Craker's facility and we wanted to do this Chemic
11 study, NIDA and the Public Health Service wouldn't
12 be involved at all.
13 Q You would have to get a protocol approved
14 somewhere in the government.
15 A No, no, no, because there is not human
16 use. You can do all sorts--as long as the
17 necessary DEA licenses are in place, the key issue
18 is when you want to take the data from your study
19 and then submit it to FDA, then, FDA will evaluate
20 the protocol to see if they accept the data as
21 valid.
22 But you don't have to have prior approval
0666
1 from FDA when you do an analytical study like this
2 that doesn't involve humans. So that what we're
3 trying to do is get the Public Health Service and
4 NIDA out of the picture; they're only in the
5 picture just for marijuana only because they have a
6 monopoly. And that is what is so obstructing the
7 system. If Professor Craker had the facility, this
8 study would have been done years ago.
9 Q Yes, but Dr. Doblin, then, your dispute is
10 really with the PHS committee and NIDA and not DEA;
11 is that correct?
12 A Well, for the portion that is trying to
13 purchase NIDA marijuana, it's with NIDA. For the
14 portion where we're trying to import, where we're
15 seeking the DEA permit, our concern is with DEA.
16 JUDGE BITTNER: Could I just interject?
17 Doctor, I think you just said marijuana is the only
18 drug for which PHS reviews protocols. And that's
19 where there's no humans.
20 THE WITNESS: And where you're not asking
21 for Government money. So when you want to get
22 Government money, then, of course, they--
0667
1 JUDGE BITTNER: Right.
2 THE WITNESS: --have the whole grant
3 review process.
4 JUDGE BITTNER: If you either want
5 government money, or you want to use people, you
6 have to--
7 THE WITNESS: Yes.
8 JUDGE BITTNER: People requires more.
9 THE WITNESS: Yes, people requires FDA;
10 Government money requires whichever agency you're
11 going to do it. But just analytical lab research
12 requires the researchers to have the DEA
13 permissions to do the research, and that's it.
14 JUDGE BITTNER: And the reason that
15 marijuana is in this special category is that--
16 THE WITNESS: The Government has a
17 monopoly on the supply.
18 BY MR. BAYLY:
19 Q Dr. Doblin, I think you indicated that
20 Chemic has a registration as an analytical
21 researcher.
22 A I don't know if it's analytical
0668
1 researcher; I know there's like research license
2 and analytical.
3 Q Well, chemical analysis. Let me rephrase
4 that.
5 A Yes, yes, yes, yes, yes, it has a DEA
6 license for that.
7 Q And they previously have done studies with
8 this vaporizer under that registration, correct?
9 A Yes, it was their assumption that that
10 would be sufficient.
11 Q And sometime back in the latter part of
12 2000, and you can correct me on the chronology
13 here, but you supplied them with some marijuana for
14 this research, did you not?
15 A Well, I didn't supply them; DEA-licensed
16 facilities supplied them.
17 Q All right; and what facility was that?
18 A Well, from what I understand, there is
19 only one place in the United States that can accept
20 anonymous samples for analysis, and they received
21 marijuana that they analyzed for potency and then
22 had extra and sent some to Chemic with all the
0669
1 proper DEA--
2 Q Where is this place located?
3 A This is in Sacramento, California. It's
4 called Drug Detection Lab.
5 Q And how did you know that Chemic got this
6 marijuana from this place?
7 A Well, we had contacted Drug Detection Lab
8 to see if they might be able to send some.
9 Q So you arranged with this facility to send
10 some marijuana to Chemic.
11 A Yes.
12 Q For research?
13 A Yes.
14 Q And this facility, is this a facility that
15 makes marijuana or transfers marijuana to
16 compassionate use users?
17 A No, no.
18 Q What are they for? What do they do?
19 A Well, they do a lot of drug testing. I
20 mean, just for, you know, urine testing, blood
21 testing, things like that. And then, they have a
22 license to take anonymous samples. So why I
0670
1 understand DEA gave them the license is because
2 there are people around the country that have drugs
3 that are illegal. They don't know what's in them.
4 They can send them on an anonymous basis
5 to this laboratory to have them analyzed, and then,
6 they call with some code number, and then, they
7 find out what's in them, and then, DEA uses that
8 information to track what's made available on the
9 illicit market.
10 Q Right; and then, you contacted this
11 facility to send some marijuana to Chemic?
12 A See, initially, I have multiple
13 relationships with this particular company.
14 JUDGE BITTNER: Which?
15 THE WITNESS: This is this Drug Detection
16 Lab.
17 JUDGE BITTNER: Okay.
18 THE WITNESS: And what we wanted to do was
19 to compare the potency of marijuana in marijuana
20 buyers' clubs with what's available from NIDA. So
21 years ago, we worked with them, where they received
22 samples from various buyers' clubs and compared it
0671
1 to the potency from NIDA marijuana and discovered
2 that the buyers' clubs offer marijuana average of
3 around 12 percent THC. And so, that's what led us
4 to believe that patients prefer a higher THC
5 content marijuana.
6 BY MR. BAYLY:
7 Q Well, Dr. Doblin, what I'm interested in
8 finding out is you indicated you contacted somebody
9 at this Sacramento DEA-registered facility to
10 transfer the marijuana to Chemic; is that correct?
11 A Yes.
12 Q Can you tell us who you contacted?
13 A Yes, Jeff Zender.
14 Q Who?
15 A Jeff Zender is the head of that company.
16 Q And did you tell Mr. Zender why you wanted
17 him to send this marijuana to Chemic?
18 A For the vaporizer research, yes.
19 Q Did you find out whether he was authorized
20 to do this, to send the marijuana to Chemic?
21 A I got the impression he was.
22 Q Did you ask him?
0672
1 A Yes, yes.
2 Q And he told you yes?
3 A I believe so; yes, I think so. I mean, he
4 is regulated by the DEA; he didn't want to do
5 anything that would cause that registration to be
6 put in jeopardy.
7 Q So you knew when you called him that he
8 had a DEA--or I guess the Sacramento facility had a
9 DEA registration as a chemical analyst.
10 A Yes, we have another project with him
11 which is to test the purity of ecstasy pills that
12 are being distributed around the country.
13 Q But let's talk about just the marijuana
14 now.
15 A Yes.
16 Q Did you know whether that registration
17 entailed them sending marijuana to other
18 registrants?
19 A I got the impression that it did, yes. He
20 certainly didn't say that he didn't have permission
21 to do that. He indicated that that would be
22 possible for him to do, and since he's heavily
0673
1 regulated by DEA, I assumed that he had the
2 permission to do that.
3 Q Did you subsequently find out that he did
4 not have permission to do that?
5 A I don't know that I ever found that out,
6 no. I know that at some point, DEA went to talk to
7 him about it, and I wasn't sure that, you know, he
8 still has his DEA licenses, so I assume that that
9 was something that was within his purview to do.
10 Q Did you ever supply Chemic with some
11 marijuana that was designated for a compassionate
12 use patient?
13 A Well, I believe that some compassionate
14 use patient whom I don't know which one, supplied
15 marijuana to Drug Detection Lab for analysis to
16 compare with the marijuana that was coming in from
17 the buyers clubs.
18 Q I'm sorry; they supplied it to whom?
19 A Well, excuse me, to Drug Detection Lab.
20 Drug Detection Lab did our potency study, comparing
21 marijuana that was made available by NIDA to
22 patients with marijuana that was made available to
0674
1 patients through the various buyers clubs around
2 the country.
3 Q Now, was it your advice to have the
4 compassionate use patients supply--give their
5 marijuana to this particular registrant?
6 A Well, I didn't actually speak to the
7 patients, but that was our goal was to try to
8 evaluate NIDA marijuana compared to the marijuana
9 available in buyers' clubs.
10 Q Now, you say it was your goal, but what
11 did you do to help have the patients donate their
12 medical marijuana to this registrant?
13 A Well, we made it publicly known that we
14 were interested in having some NIDA marijuana to
15 evaluate from what compassionate use patients had
16 so that that could be then evaluated and tested.
17 Q Did you attempt before you did that to see
18 if you could get some from NIDA for this purpose?
19 A By this point, after NIDA had refused to
20 provide marijuana for other purposes, I assumed
21 that they would not provide it, and now, after we
22 tried to get it from NIDA, you know, waiting two
0675
1 years to find out NIDA refuses to provide it, it
2 seems like our assumption is correct that we would
3 not have been able to get it directly from
4 Q Okay; so basically, you did this, then, to
5 circumvent NIDA.
6 A Not to circumvent NIDA. I mean, I think,
7 from my understanding of the situation, you know,
8 this marijuana did not go to any human for use; it
9 strictly went for testing, and so, it was a way to
10 test NIDA marijuana.
11 Q But subsequently, you learned, Dr. Doblin
12 that you were not authorized to diver that medical
13 use or marijuana used for the compassionate use
14 program to this chemical analysis; is that correct?
15 MS. CARPENTER: Objection to the form of
16 the question. It assumes facts not in evidence.
17 There's no testimony that Dr. Doblin diverted
18 anything.
19 JUDGE BITTNER: Sustained.
20 BY MR. BAYLY:
21 Q Dr. Doblin, it was because of your request
22 and help that this marijuana went from the
0676
1 compassionate use people to this chemical analysis
2 in Sacramento; is that correct?
3 MS. CARPENTER: Same objection.
4 JUDGE BITTNER: Overruled.
5 THE WITNESS: Yes.
6 BY MR. BAYLY:
7 Q And then, it was based on your urging that
8 the Sacramento DEA registrant sent it to Chemic for
9 their analysis.
10 A Yes.
11 Q And did you subsequently learn that that
12 was not authorized, that you were not authorized to
13 do that?
14 MS. CARPENTER: Objection, asked and
15 answered. Assumes facts not in evidence.
16 MR. BAYLY: I don't think it's been
17 answered.
18 MS. CARPENTER: It assumes, A, that he
19 wasn't authorized to ask somebody to do something,
20 and he did testify that he did not know that he
21 was--I'm sorry; can you read back the question?
22 JUDGE BITTNER: No, I think I know where
0677
1 we are.
2 MS. CARPENTER: Okay.
3 JUDGE BITTNER: And overruled.
4 THE WITNESS: I got--in conversations with
5 Jeff Zender, I understood that DEA came to speak to
6 him about it and that he explained what he had
7 done, and I didn't get the impression that it was
8 necessarily forbidden, but I certainly got the
9 impression that what we wanted to do was to go
10 directly to NIDA, that that would be a preferable
11 approach. And that's what we've done.
12 BY MR. BAYLY:
13 Q Did anyone from DEA ever contact you about
14 this--
15 A No.
16 Q --about this incident?
17 A No, no.
18 Q Well, let me ask you this: do you know if
19 it's legal for a compassionate use person to divert
20 the marijuana to a purpose other than using it for
21 their own medical use?
22 A Well, my understanding of diversion is to
0678
1 have it used by some other person rather than by
2 some analysis, so for a medical marijuana patient
3 getting marijuana from NIDA under the compassionate
4 use program, if they wanted to know what was in the
5 drug, if they wanted to verify that the information
6 that they got from NIDA about this medicine that
7 they were taking was accurate, I thought that they
8 would probably have the right to send it to a DEA-licensed
9 lab and have it analyzed.
10 Q Okay; but that was not the purpose,
11 though, Dr. Doblin, that this marijuana was taken
12 from the compassionate use people and given to the--ending
13 up in Chemic, right? They weren't
14 analyzing it just to see what the user was getting.
15 MS. CARPENTER: I have two objections to
16 that question: one, it misstates a fact in
17 evidence, because there's no evidence anything went
18 to Chemic, and two, the characterization that it
19 was taken from compassionate use patients and given
20 to Chemic improperly characterizes the testimony.
21 JUDGE BITTNER: Hold on. I need to back
22 up a little bit.
0679
1 MR. BAYLY: I can rephrase.
2 JUDGE BITTNER: Would you?
3 MR. BAYLY: I think half the objection is
4 incorrect, because there was definitely evidence
5 that it got to Chemic, but I can rephrase the
6 question.
7 JUDGE BITTNER: Okay; if you would
8 rephrase the question, Mr. Bayly.
9 MR. BAYLY: Okay; thank you.
10 BY MR. BAYLY:
11 Q Okay; Dr. Doblin, you agree with me that
12 it was not Chemic--Chemic got this marijuana from
13 the compassionate use people to do chemical
14 analysis, correct?
15 A Yes, yes.
16 Q But it was not Chemic's intention to do
17 this only for the purpose of notifying the
18 compassionate use people about the content of what
19 they were getting; is that correct?
20 A There's a two-step process, okay? So the
21 chemical analysis was done by the Drug Detection
22 Lab, all right? They had extra supplies. They
0680
1 sent them to Chemic for use in the vaporizer study.
2 Q All right; now, you are familiar, are you
3 not, with DEA recordkeeping requirements.
4 A Pretty much, yes.
5 Q And is it your understanding that when a
6 Schedule 1 substance is distributed to a person
7 other than the ultimate user that a DEA 222 order
8 form is necessary.
9 A Yes, yes.
10 Q And was that done in this instance from
11 the compassionate use people when they transferred
12 the marijuana to this DEA registrant in Sacramento?
13 A Well, it is my understanding that Drug
14 Detection Lab is licensed by the DEA to accept
15 anonymous samples without DEA Form 222 and that
16 that is a substantial part of their business and
17 that they do that all the time and that people send
18 them anonymous samples for analysis without
19 requiring Form 222.
20 Q Well, these are anonymous samples from--are you
21 saying the samples from the compassionate
22 use people were anonymous?
0681
1 A Yes, yes, as far as I know. I don't
2 know--
3 Q So DEA has no idea who transferred, other
4 than knowing it's perhaps a compassionate use
5 person, DEA has no idea which one transferred the
6 marijuana to this DEA registrant in Sacramento?
7 A I think that's true, yes. I think DEA
8 doesn't have any information, nor do I, as to which
9 one did it.
10 Q Well, did you--let me ask this: how did
11 you solicit, how did you get the word out to the
12 compassionate use people to transfer some of their
13 compassionate use marijuana to this registrant in
14 Sacramento?
15 A Well, we were in contact with them,
16 because we were also trying to do Ethan Russo's
17 study. We were involved with trying to see what
18 they have to say about quality, so that some of
19 them, I know who they are; some of them, I don't
20 even know who they are, so we will just, you know,
21 try to indicate that we were interested in this
22 sort of project.
0682
1 Q Well, did you contact them, Dr. Doblin,
2 the ones you knew by email or mail or calling them?
3 Or how could you--
4 A No, I had no direct contact in order to
5 facilitate it. I sort of put the word out through
6 others to try to reach the patients to see if
7 anyone would be interested in doing that.
8 Q So you asked other persons to contact the
9 compassionate use people to transfer their
10 marijuana.
11 A Yes.
12 Q Who did you ask?
13 A I asked Dr. Gieringer, among others.
14 Q Did Dr. Gieringer agree to contact these
15 compassionate use people?
16 A Yes, he did.
17 Q So you never discussed any ramifications
18 with the compassionate use people of sending their
19 marijuana to this DEA registrant.
20 A No, I didn't.
21 Q Anyone else besides Dr. Gieringer that you
22 contacted to solicit the compassionate use people
0683
1 to transfer their marijuana?
2 A Well, there were a--there was a lot of
3 people that knew that we were trying to do the
4 water pipe vaporizer research, so that was, I
5 think, widely known in the community.
6 Q When you say community, what--
7 A Just the medical marijuana community, the
8 compassionate access patients.
9 Q Let's talk a little bit about Dr. Abrams.
10 You were testifying about his research protocol
11 being denied initially.
12 A Right.
13 Q And when was that denied?
14 A I think it was FDA approved in 1994,
15 probably denied around 1995 or so.
16 Q 1995?
17 A 1995.
18 Q And then, it was eventually approved in
19 1997.
20 A A completely different protocol was
21 eventually approved.
22 Q And he got the grant.
0684
1 A Yes, he did.
2 Q And what--you say a completely different
3 protocol was approved in 1997. Did that derail Dr.
4 Abrams' research?
5 A Well, the research that he originally had
6 intended to do that we had initially set out to do
7 was derailed, yes.
8 Q All right--
9 A For example, the first study was in AIDS
10 wasting patients. We were looking to see could
11 marijuana be helpful to AIDS wasting patients. The
12 protocol that was approved, specifically he was
13 told by marijuana to exclude AIDS wasting patients
14 from the study.
15 Q Well, Dr. Doblin, was Dr. Abrams then
16 precluded from trying to persuade the PHS to go
17 along with his initial protocol? Do you know if he
18 went back to him and said hey, wait a minute, let's
19 see if we can work this out?
20 A He sent a letter to Dr. Leschner outlining
21 his objections to the critiques that were made, and
22 I think he believed that Dr. Leschner, if he would
0685
1 have been persuaded, would have contacted him and
2 said oh, okay, we will let you go forward with this
3 study, but that did not happen.
4 Q Right, but he's since 1997, as far as you
5 know, he has been able to obtain marijuana from
6 NIDA to do the studies that he wants to do; is that
7 correct?
8 A Exactly; he's a world class researcher,
9 which makes me believe that his original protocol
10 was also scientifically meritorious, despite the
11 fact that it was determined not to be
12 scientifically meritorious in this letter from Dr.
13 Leschner. He's certainly demonstrated his ability
14 to design and implement and conduct scientifically
15 meritorious studies.
16 Q Right; but right now, he's even working on
17 a vaporizer himself, is he not?
18 A He used the data from Chemic as part of
19 his application to FDA, and he has now completed
20 his vaporizer study, which was funded by CMCR, and
21 he's in the data analysis process right now.
22 Q Okay; but since 1995, since his protocol
0686
1 was denied in 1995, there have been no other
2 problems with him obtaining NIDA marijuana, have
3 there?
4 A Well, what he has realized it that he will
5 not get NIDA funding or NIDA marijuana for research
6 looking at the benefits of marijuana in specific
7 patient populations; but as long as he phrases his
8 studies as safety studies, that then, it's possible
9 to get NIDA marijuana and possibly even a NIDA
10 grant and it's my understanding that he's currently
11 trying to look at the safety of marijuana combined
12 with opiate painkillers.
13 So that it has completely derailed our
14 orphan drug designation efforts to do work with
15 AIDS wasting, that we've come to the conclusion
16 that we will not get permission from NIDA to use
17 marijuana for studies to develop marijuana for AIDS
18 wasting.
19 Q Since 1997, has Dr. Abrams asked the PHS
20 committee to revisit this issue?
21 A No, I mean, he was successfully
22 discouraged, and that's the problem that I think
0687
1 that we see all over America, is that a lot of
2 researchers who would like to do research in this
3 area have given up hope, don't think it's worth
4 their time and decided based upon the experience
5 for us, we can't even buy 10 grams after two years.
6 We're the only people in America who can't get 10
7 grams of marijuana.
8 [Laughter.]
9 Q Well, Dr. Doblin, did Dr. Abrams tell you
10 that he's so discouraged that he's not going to get
11 the protocols that he wants approved?
12 A In terms of AIDS wasting. I mean, he's
13 worked with--
14 Q Can you answer the question? Did he tell
15 you that?
16 A At the time, yes. At the time, he gave up
17 trying to do the study with AIDS wasting patients.
18 Q When you say at the time--
19 A At the time when NIDA decided not to
20 provide the marijuana for him.
21 Q That was in 1997?
22 A Or 1996 or so.
0688
1 Q 1996?
2 A Right.
3 Q The PHS committee, now, that's a whole
4 committee of people that review it. It's not just
5 Dr. Leschner; is that correct?
6 A Well, as far as I know, that was prior to
7 the creation of the standards that the HHS created.
8 I think that was 1999 that HHS created the
9 standards where there would be this Public Health
10 Service review of studies that were privately
11 funded. And so, Dr. Leschner rejected Dr. Abrams'
12 study prior to those standards that were put into
13 place. And all that Dr. Abrams got was a letter
14 from Dr. Leschner, one page, several paragraphs,
15 saying your study is not scientifically
16 meritorious.
17 I assume that Dr. Leschner probably asked
18 other people to review the protocol, but there were
19 no formal Public Health Service procedures at that
20 time.
21 Q Okay; and that was changed later on,
22 right, so that, for example, you've got in
0689
1 Government Exhibit No. 52B, there now is a
2 formalized committee that reviews these protocols.
3 A Yes, yes.
4 Q Now, you've mentioned Dr. Abrams is doing
5 some studies on a vaporizer. Is this something
6 that he has pursued for a long time?
7 A For several years. I mean, we brought the
8 idea to him to work with this particular vaporizer
9 that we had preliminary data. We made available to
10 him the data that Chemic had already developed, and
11 then, he was able to submit that to FDA and conduct
12 a study with funding from CMCR.
13 Q Are you satisfied that Dr. Abrams in order
14 to conduct these studies has obtained the marijuana
15 he needs through the PHS and NIDA?
16 A Yes; I mean, I think the CMCR has been
17 able to obtain marijuana from NIDA for a number of
18 studies, and that's been very helpful. I think the
19 distinction is that they're not trying to make
20 marijuana into a prescription medicine, which is
21 MAPS' explicit goal, so therefore, I think that
22 sends up red flags, and anything that we do gets
0690
1 shut down.
2 Q Well, Dr. Doblin, there is nothing that
3 prohibits anybody in CMCR from sharing their
4 results with a pharmaceutical company, is there?
5 A No, and in fact, once Dr. Abrams gets his
6 data and puts it in the public domain through
7 publication, we can use it and cite it in our
8 submissions to FDA for further studies.
9 Q And that's true of any CMCR DEA registered
10 researcher for marijuana, is that correct?
11 A Yes, yes.
12 Q And they could share that with a
13 pharmaceutical company.
14 A Yes, and I think CMCR is doing helpful
15 research, and I commend NIDA for providing
16 marijuana to those studies and to DEA for approving
17 them. I think those are helpful steps.
18 Q And throughout CMCR's history, other than
19 Dr. Abrams, is there anyone that you know of that
20 had problems getting marijuana through the PHS and
21 NIDA?
22 A Well, Dr. Russo.
0691
1 Q Is Dr. Russo now part of the CMCR?
2 A Dr. Russo has been hired by GW
3 Pharmaceuticals as one of their scientific advisors
4 on their clinical research, so that now that he is
5 involved in the development of Sativex, he is not
6 able to do anything to develop the marijuana plant
7 itself.
8 Q So the answer is no, he's not.
9 A Right.
10 Q Okay; and then, he has no interest now in
11 developing a herbal marijuana as a possible
12 medicine.
13 A I think personally that he would be
14 interested in seeing studies conducted, but
15 professionally, he's focused on his work with GW
16 Pharmaceuticals.
17 Q Now, let's talk a little bit about Dr.
18 Russo. When was his protocol denied?
19 A His protocol was denied, I think, around
20 1998, 1999. He had three denials. The first two
21 times, starting around 1996, 1997, he was
22 interested in seeing if he could get a government
0692
1 grant, so the first two times, he applied to
2 receive a grant for the study and was both times
3 rejected for reasons that he considered to contain
4 some valid critiques, some invalid critiques.
5 He felt that overall, that they were more
6 or less invalid but that he realized that since he
7 was asking for government money that it was
8 certainly within the rights of, you know, the
9 Public Health Service to review and deny him. The
10 third time--
11 Q Well, let's get a year on this. When are
12 you talking about?
13 A I think it was 1996, 1997, 1998, 1999.
14 There was, like, a four-year process.
15 Q All right.
16 A We subsequently in conversations with Dr.
17 Russo, we decided that it would be better to
18 eliminate the effort of asking for government
19 money. And so, then, he got a protocol approved by
20 the FDA by his institutional review board and then
21 submitted that protocol to the Public Health
22 Service for requesting to purchase the necessary
0693
1 marijuana at our own expense. And that was also
2 denied.
3 Q And what year was that?
4 A I think it was 1999.
5 Q And do you know when Dr. Russo was hired
6 by GW?
7 A It was several years later. I actually
8 encouraged Dr. Russo to continue to respond to the
9 Public Health Service, as, for instance, I have
10 encouraged Chemic to continue to respond. And Dr.
11 Russo just said there's no point; he just gave up.
12 It was just a frustrating situation for
13 me. I said you should continue to fight; you
14 should continue to try to negotiate scientifically,
15 but eventually, you know, maybe they will agree to
16 something, but he just felt it would never happen,
17 and so, he was successfully discouraged. I think
18 this was the outcome that NIDA had hoped for, and
19 he gave up.
20 Q All right; Dr. Doblin suggested to him
21 that he could either continue to fight or
22 negotiate; is that what you're saying?
0694
1 A My recommendation was that he continue to
2 respond to the critiques that were made of the
3 protocol, and he decided that he didn't want to
4 invest his time in doing that.
5 Q Now, you disagreed with several of the
6 protocols that were not approved, and did you ever
7 contemplate legal action?
8 A No, I did not. I did not. I mean, he had
9 a protocol approved by FDA, approved by the
10 Institutional Review Board when the Public Health
11 Service refused to provide the marijuana; no, I did
12 not contemplate legal action, because Dr. Russo
13 gave up. You know, there was--
14 Q Dr. Doblin, do you have any idea how many
15 CMCR researchers that had PHS protocols approved?
16 A My understanding was that once they went
17 through the vetting process that CMCR had
18 established, I think that everyone that CMCR
19 submitted to NIDA was approved. And what Senator
20 Vasconcellos said was that sometimes, there's
21 negotiation back and forth about changing protocol
22 designs, but I think CMCR has been successful in
0695
1 obtaining marijuana from NIDA for all the studies
2 it put forward.
3 MR. BAYLY: And when you say CMCR, how
4 many researchers are you talking about in terms of
5 CMCR?
6 JUDGE BITTNER: Researchers or projects?
7 I don't know if they're the--I mean, you could have
8 one project with six or seven different
9 researchers, I suppose.
10 MR. BAYLY: Well, I thought they were all
11 individually--
12 JUDGE BITTNER: I don't know.
13 THE WITNESS: No, no, some of them are
14 teams of researchers.
15 BY MR. BAYLY:
16 Q Teams?
17 A I understand that there's roughly 15
18 projects. See, I think at the same time that CMCR
19 is moving forward, the initiatives were moving
20 forward in multiple states. People were trying to
21 get marijuana legal in different states, and I
22 think that it would have propelled that movement
0696
1 even more if NIDA had refused to provide the
2 marijuana to the State of California for its own
3 studies.
4 It would have been too transparent, the
5 fact that they were doing these initial studies,
6 that they were not aimed at making marijuana a
7 prescription medicine; I think that they were under
8 those circumstances able to get the marijuana.
9 Q Would a doctor, a researcher might have
10 more than one protocol, correct?
11 A Yes, that's true. For instance, Dr.
12 Abrams has had the vaporizer protocol, and then,
13 he's had a protocol for AIDS-related neuropathy,
14 AIDS-related pain, and that study has been
15 completed with promising results, and it is pending
16 publication.
17 Q And both of those protocols were approved?
18 A Yes, I think 15 protocols in total were
19 approved by CMCR.
20 Q The one for the vaporizer, when was that
21 approved?
22 A Maybe two years ago.
0697
1 Q Okay; I won't hold you to dates, but then,
2 you said he had another one for pain.
3 A Yes, AIDS-related neuropathy, AIDS-related
4 pain.
5 Q And when was that protocol approved?
6 A Maybe four years ago, something like that.
7 Q So in light of those protocols being
8 approved, then, Dr. Doblin, do you know if Dr.
9 Abrams has seen a need to revisit the 1995 protocol
10 rejection?
11 A No, and in fact, what's happened, one of
12 the main reasons is that with the rise of the
13 protease inhibitors, the incidence of AIDS wasting
14 has dramatically declined to the point where he
15 felt that his research time would be better devoted
16 to other clinical indications. It's a problem in
17 other parts of the world more so than in the United
18 States.
19 Q Now, I think, Dr. Doblin, you testified
20 about one of Dr. Abrams' AIDS wasting experiments,
21 or did you not?
22 A Well, the million dollars that he got from
0698
1 NIDA to do his study that finally got approved was
2 explicitly not in AIDS wasting subjects; it was in
3 HIV-positive subjects who were not AIDS wasting.
4 Q Dr. Doblin, let me just ask you a few
5 questions. You've talked about some plans about
6 developing a pharmaceutical company from the
7 funding, and you say you have 1,500 members; is
8 that correct?
9 A Yes.
10 Q And those members are the ones that supply
11 MAPS with their operating budget.
12 A Yes.
13 Q And how long has MAPS been supplied by its
14 members with its operating budget?
15 A Well, MAPS was started in 1986. So we've
16 had members and money coming in ever since then.
17 Q And what is your budget, how much have you
18 taken in, say, starting in 2001?
19 A Well, last year's budget was somewhere
20 like $800,000. The year before that was a little
21 over $1 million; before that was, like, $600,000,
22 so I would say in the last five years or four
0699
1 years, it's probably been $4 million, something
2 like that.
3 Q But that's--you're talking that over the
4 last four years.
5 A Yes, four, five years, yes.
6 Q And that includes your salary, of course.
7 A Yes.
8 Q And who else works for MAPS full time?
9 A We have about four different people who
10 work for MAPS full time. We have several people
11 who just handle the membership, donations, and
12 membership communications. We have someone whose
13 full time job is to look at the MDMA literature and
14 keep up-to-date with that. There's over 2,000
15 papers in Medline on MDMA, and we have to
16 continually review that for submission to FDA. And
17 then, we have researchers that we give grants to
18 that do studies that are not employees but that do
19 projects under contract to MAPS.
20 Q Now, when you consider the $4 million
21 incoming and those expenses that you related, what
22 is the outgoing, what do the expenses come to
0700
1 roughly?
2 A Well, we usually spend what we bring in.
3 I mean, we reserve some; we have some that is
4 restricted to certain projects that we have yet to
5 obtain approval for or that we get some for
6 projects, and we spend it out over time.
7 Q Well, how much of the actual money--let's
8 say--what did you say? $4 million over the last
9 two years?
10 A Four or five years, yes.
11 Q How much of that goes into research?
12 A It varies. I would say that of that
13 amount, probably in excess of $1 million. See, the
14 situation is that until 2004, we worked since 1986
15 to 2004 to get the first study approved with MDMA.
16 So most of our resources have been spent on
17 protocol development, educational projects, trying
18 to get to a position where we actually had research
19 studies that we could, you know, spend money on.
20 So now that we have permission, our
21 budgetary needs are increasing; our access to
22 donors is increasing. So I believe that it will be
0701
1 possible for us to raise the $5 million to $10
2 million that we need to make MDMA into a medicine;
3 I believe it will be possible to raise the $5
4 million to $10 million that I think we need to make
5 marijuana into a medicine should we get our own
6 facility.
7 Q Would it be safe to assume that you would
8 be more confident about MDMA than marijuana at this
9 point?
10 A Without an independent source of supply,
11 we're going basically nowhere with marijuana.
12 Q Well, Dr. Doblin, let me ask you: other
13 than CMCR, what researchers are you subsidizing for
14 marijuana research?
15 A Well, we're not doing any marijuana
16 research because we can't seem to get permission to
17 get marijuana. So that we're subsidizing, you
18 know, we're spending money on perennial litigation,
19 as Bonner said, which is not our goal, not our
20 priority; it is a diversion of our resources from
21 what the purposes should be ideally for research,
22 so that, you know, we don't really have any
0702
1 research other than this now attempt to do the
2 vaporizer research ongoing for marijuana.
3 Q Okay; and that's--you're talking about the
4 Chemic, right?
5 A Right.
6 Q And that's very much up in the air right
7 now.
8 A Right, right, right.
9 Q Okay; and there are no pharmaceutical
10 companies in the pipeline as far as you know that
11 are seeking your assistance or seeking MAPS'
12 assistance?
13 A Well, again, MAPS is a pharmaceutical
14 company. There are no pharmaceutical companies;
15 there are--no, there are no pharmaceutical
16 companies seeking MAPS' assistance.
17 Q Dr. Doblin, you've been present here the
18 entire time, have you not?
19 A Yes.
20 Q And you've listened to all the witnesses.
21 A Yes, I have.
22 Q So you're basically the person that is
0703
1 sponsoring Dr. Craker's application.
2 A Yes.
3 Q He wouldn't be here without you; is that
4 correct?
5 A Yes, that's true.
6 Q You heard Dr. Martin testify.
7 A Yes, I did.
8 Q And you heard his estimate about how much
9 it would cost to bring a drug to market.
10 A I don't know that he actually gave an
11 estimate. I heard him explain where the numbers
12 came from, and I could actually--a large portion of
13 my dissertation was focused on trying to estimate
14 the amount of money that it would take to bring
15 MDMA or marijuana through the FDA system, and so, I
16 looked very closely at the number that was
17 developed by the Tufts Center for the Study of Drug
18 Development, which is the number that he cited.
19 And so, I can explain where they got their
20 number and why I think the number that I'm giving
21 you of $5 million to $10 million is reasonable for
22 marijuana or for MDMA.
0704
1 Q How much, you're saying?
2 A $5 million to $10 million.
3 Q All right; now, you've talked about Chemic
4 not getting its protocol approved; obviously, we
5 just had that here as well as Dr. Russo, Dr.
6 Abrams. Anybody else?
7 A No, that's it.
8 Q That's it? And we don't know of a
9 pharmaceutical company that has indicated any
10 interest in developing the crude plant marijuana as
11 medicine.
12 A I don't know if characterizing it as crude
13 is appropriate.
14 Q All right; strike the adjective crude.
15 A There may be pharmaceutical companies that
16 are working on it. They have no reason to contact
17 MAPS necessarily, but I am not aware of any. I
18 think with the political obstacles, the fact that
19 it's difficult to patent; I think that for a for
20 profit company to get involved in this with the
21 current NIDA monopoly makes no sense, so I don't
22 there are any.
0705
1 Q Now, Dr. Doblin, it's your belief that if
2 Dr. Craker gets his DEA registration, then, or DEA
3 should give Dr. Craker's registration so that there
4 will be a supply for researchers who get an FDA
5 approval.
6 A That's true. What I would say is that
7 what the FDA likes to see is what's called a
8 clinical plan, so that once we were to have a
9 supply from Dr. Craker, what we would do, and we've
10 done this for MDMA in association with FDA as well,
11 so that you develop a clinical plan. You pick your
12 patient population. You sort of outline in general
13 the sequence of studies and how you think roughly
14 they need to be designed, how many subjects, how
15 long you think they'll take.
16 And you have a whole time line and a plan
17 for the development from the first pilot study to
18 the final phase three studies, and you develop that
19 clinical plan, and we would do that; MAPS would
20 make a strategic analysis just like a
21 pharmaceutical company of which patient population,
22 did we want to go with another indication for
0706
1 orphan drug designation; did we want to work with
2 AIDS wasting to work with patients in other parts
3 of the world and some patients in America that
4 still have AIDS wasting.
5 We would then have to do an analysis, a
6 clinical plan. We would show that to FDA, and
7 then, we would negotiate, and then, we would decide
8 what kind of researchers we need to contact. Maybe
9 it would be for MS. Maybe it would be for AIDS-related
10 neuropathy. Maybe it would be for AIDS
11 wasting.
12 We would try to figure out what was the
13 most likely path to get from where we are now to
14 having an approved medication, and then, we would
15 solicit researchers. We don't anticipate
16 researchers will come to us because they're all
17 discouraged. Once we, of course, if we did manage
18 to get DEA licensing for Professor Craker's
19 facilities, I think that we would have quite a few
20 researchers contact us about their interests.
21 Q Dr. Doblin, you say the researcher
22 discouraged. Which researchers are you talking
0707
1 about? Who are you talking about?
2 A Well, like Ethan Russo gave up. There's a
3 researcher, Paul Consroe, who has recently retired.
4 I mean, he was frustrated by NIDA, and we couldn't
5 even get him to apply for permission to do studies.
6 Q Could you give us his name, please?
7 A Paul Consroe.
8 Q Could you spell the last name, please?
9 A C-O-N-S-R-O-E.
10 Q Now, this was a DEA-registered researcher?
11 A I am not sure what kind of studies that he
12 had conducted. I think he may have conducted some
13 projects in the past, but I'm not positive. But
14 the point is that as a sponsor, you are trying to
15 focus on individual researchers. Sponsors have
16 been discouraged. MAPS is not trying to sponsor
17 research.
18 Q But Dr. Doblin, the question was do you
19 know if Paul Consroe is a DEA registrant.
20 A Currently, he's not.
21 Q He's not.
22 A No, he's retired. He's not interested in
0708
1 doing any research at this point.
2 Q Okay; so he never submitted a protocol.
3 A No; he was discouraged from doing so. He
4 never thought he would get permission; didn't think
5 it was worth his time. People in academia need to
6 struggle to get grants, to keep their income, to
7 keep their jobs, and it's just too difficult.
8 Q When you said he was discouraged, is that
9 because of what happened to Dr. Russo?
10 A This was even prior to that, what had
11 happened to Dr. Abrams.
12 Q Dr. Russo and Dr. Abrams.
13 A Well, this was prior--I mean, this was
14 quite a long time ago that I had spoken to Dr.
15 Consroe when I was trying to see if he was also
16 interested.
17 Q I'm sorry; when did you speak to Dr.
18 Consroe?
19 A Ten years ago, maybe.
20 Q How many years ago?
21 A Ten years ago, maybe.
22 Q Oh, my goodness.
0709
1 All right; any other names of researchers
2 that fall into the class of Mr. Consroe?
3 A No, I don't have any other names that I
4 could give you.
5 Q Okay; I think, Dr. Doblin, you indicated
6 you had a Ph.D. in--what did you say?--public
7 policy?
8 A Yes.
9 Q Yes? Okay; have you got any other
10 degrees? You don't have a Ph.D. or a masters in
11 pharmacology.
12 A No.
13 Q Do you have any degree in biochemistry?
14 A No.
15 Q Any degree in botany?
16 A No.
17 Q Okay; you don't have a medical degree,
18 then, I take it?
19 A No.
20 Q Have you ever worked for HHS or any of its
21 components?
22 A I came really close to getting a job with
0710
1 FDA, but DEA was not that comfortable, actually,
2 and I was ending up--I wanted to work in the--I had
3 a Presidential Management Internship that I got
4 after I had my master's degree, and I wanted to go
5 into the Federal Government service, but I wanted
6 to work at FDA in the branch that regulates
7 Schedule 1 drugs.
8 And so, this was, at the time, the pilot
9 drug evaluation staff. And I tried to get a job
10 there, and John Harder, who was head of that
11 division, wanted me there. But because I had been
12 involved suing the DEA before as far as the MDMA
13 administrative law judge hearings about the
14 scheduling of MDMA, the DEA did not want me to be
15 working in this branch that coordinated closely
16 with DEA, and that was communicated to FDA.
17 And as things turned out, I was ultimately
18 not able to get the job at the FDA, but that had
19 been my goal, to try to work at the FDA, to learn
20 how they do drug development. And so I--
21 Q What year was that, Dr. Doblin?
22 A This was 1990, 1991.
0711
1 Q 1990, 1991. Okay; have you ever worked
2 for a pharmaceutical company?
3 A Other than MAPS, no.
4 Q I take it your full time, sole employment
5 is with MAPS.
6 A Yes.
7 Q Is that correct?
8 A Yes.
9 Q This has been the case since 1986?
10 A Well, I've been in school at various
11 portions of that time as well.
12 Q Do you know who in DEA discouraged FDA
13 from hiring you?
14 A I don't know who, no. I know what I was
15 told was that I could not work on anything to do
16 with marijuana, with MDMA, with any of the
17 controlled substances. That division also worked
18 with other drugs that were not controlled
19 substances and that if I were to be permitted, it
20 would have to be with something else.
21 Q Well, Dr. Doblin, how did you find out
22 that it was DEA that jettisoned your application
0712
1 with FDA?
2 A Dr. Harder told me. Dr. Harder is now
3 dead.
4 Q What's his name?
5 A He is since deceased. Dr. John Harder.
6 Q Okay; so is there anyone alive who could
7 corroborate what he said?
8 A Perhaps. I'm not sure. I'm not sure.
9 There are other people who are in that division who
10 may or may not have been aware of that, that DEA
11 did not want me to work on controlled substances
12 that were being reviewed by that division.
13 Q Can you give any other names?
14 A I'm not sure how widespread the
15 information actually was.
16 Q Okay; so the answer is no.
17 A At this point, I wouldn't know.
18 Q Okay; Dr. Doblin, have you yourself smoked
19 marijuana for recreational use?
20 MS. CARPENTER: Objection to the relevance
21 of that question.
22 MR. BAYLY: May I respond?
0713
1 JUDGE BITTNER: Yes.
2 MR. BAYLY: Yes, there's quite a bit of
3 relevance here. It's impeachment that is necessary
4 because, number one, Dr. Doblin is obviously an
5 important person on this application. He sponsored
6 it. He's testified that he wrote some information
7 for Dr. Doblin to answer the questions.
8 JUDGE BITTNER: You mean Dr. Craker.
9 MR. BAYLY: Dr. Craker; I'm sorry. I get
10 the doctors mixed up.
11 He's, of course, been here as a
12 representative of the applicant as opposed to Dr.
13 Craker. He also indicated and testified that there
14 were problems with getting employed by FDA due to
15 DEA, and of course, your background in drug use is
16 a factor. And that's something under factor, I
17 think it's factor six--four? Well, it's the
18 catchall factor, as I call it.
19 And unfortunately, I think Judge Bittner,
20 you need to know this for bias and impeachment
21 purposes as well as the deputy administrator. I
22 don't know how we can get around it.
0714
1 MS. CARPENTER: Well, let me just say that
2 I'm not sure what impeachment would come in for,
3 because there's been no foundation whether he has
4 or has not. Impeachment would be to indicate that
5 he had said something that was untrue on his direct
6 testimony. We're in cross-examination, and he has
7 said nothing about that. So there is certainly no
8 indication that there's going to be any impeaching
9 material about it.
10 Number two, although it certainly is true
11 that there is a joint relationship between the
12 applicant and Dr. Doblin, the applicant, Dr.
13 Craker, is the one who has to meet the standards
14 that are set forth in the requirement. I mean,
15 there is certainly no question of Dr. Craker
16 whether he smoked marijuana recreationally. So I'm
17 not sure why suddenly Dr. Doblin is the one who is
18 being questioned.
19 I think that's it. And I would also argue
20 that it's unduly prejudicial.
21 JUDGE BITTNER: Well, this is why I'm
22 really glad we don't have a jury. I'm not sure,
0715
1 but I can assure you that when I decide that
2 evidence is irrelevant, I don't consider it, and
3 that's the advantage of not having a jury, because
4 I know what I've considered. I don't know what a
5 jury would consider.
6 So I will overrule the objection and allow
7 the question with the caveat that I might decide
8 later that it was irrelevant, in which case, I
9 won't consider the answer. Okay.
10 So, would you answer the question, please?
11 THE WITNESS: Yes.
12 MS. CARPENTER: Let me just raise one more
13 issue, then.
14 THE WITNESS: I'm sorry.
15 MS. CARPENTER: I cost you nothing.
16 [Laughter.]
17 THE WITNESS: I take that back.
18 [Laughter.]
19 MS. CARPENTER: Oh, well.
20 JUDGE BITTNER: Okay; next question, or do
21 you still want to raise something, Ms. Carpenter?
22 MS. CARPENTER: We'll see what goes on.
0716
1 If this goes any further, I certainly will.
2 JUDGE BITTNER: Okay; next question, Mr.
3 Bayly.
4 BY MR. BAYLY:
5 Q And I take it's yes to the use, the
6 personal use of marijuana for recreational use.
7 A Yes.
8 Q And is it by smoking or other means?
9 MS. CARPENTER: Your Honor, I just don't
10 know why it's necessary to go on. He's gotten out
11 the fact that he needs, and I don't know what would
12 be the point of continuing further down the road.
13 JUDGE BITTNER: Yes, what's the relevance
14 of--
15 MS. CARPENTER: How he does it?
16 JUDGE BITTNER: --how he ingested it?
17 MR. BAYLY: All right; you can strike the
18 how, but I still have a few more follow-up
19 questions.
20 JUDGE BITTNER: Okay; well, let's see
21 where we're going.
22 MR. BAYLY: All right.
0717
1 BY MR. BAYLY:
2 Q Can you give us a rough estimate of when
3 you started using it for personal, recreational
4 use, Dr. Doblin?
5 MS. CARPENTER: Your Honor, same
6 objection. I just don't know--he's admitted that
7 he's used it. If that's relevant for factor six;
8 Your Honor can decide that. But when he started,
9 when he used it, details about that, there are
10 issues, and, you know, he's testifying in front of
11 the DEA. I think there may be Fifth Amendment
12 issues we may get into.
13 JUDGE BITTNER: Well, that one, I can
14 resolve. There is no privilege against self-incrimination
15 in administrative proceedings, which
16 means that if a witness declines to answer a
17 question, I can draw certain inferences. At least
18 that is what I have been doing for the last 25
19 years.
20 So I will overrule on that ground. Again,
21 I don't want to get into too much of this, since
22 I'm not sure if I'm not going to consider it at
0718
1 all. But I will overrule this objection.
2 So would you answer?
3 THE WITNESS: When did I start using
4 marijuana?
5 BY MR. BAYLY:
6 Q Right.
7 A In college.
8 Q And what year, roughly, was that?
9 A 1971.
10 Q And have you used it regularly since then,
11 at least once a week since then?
12 A No.
13 Q Okay; how often do you use it?
14 MS. CARPENTER: Your Honor--
15 JUDGE BITTNER: That's assuming a fact not
16 in evidence, I think.
17 BY MR. BAYLY:
18 Q When was the last time you used marijuana?
19 MS. CARPENTER: Objection, Your Honor.
20 JUDGE BITTNER: Overruled.
21 THE WITNESS: Last week.
22 BY MR. BAYLY:
0719
1 Q And can you tell us within the last year
2 how often you used it? Roughly once a week, once
3 every other week?
4 A About once a week or so.
5 Q Okay; and can you tell us your source of
6 this marijuana?
7 MS. CARPENTER: Your Honor?
8 JUDGE BITTNER: I'll sustain that
9 objection. I don't think that advises me of
10 anything.
11 MR. BAYLY: First of all, I think for the
12 record, we need to know what the objection is.
13 MS. CARPENTER: The objection is
14 relevance. It has no relevance to this proceeding.
15 JUDGE BITTNER: I don't think it's
16 relevant.
17 BY MR. BAYLY:
18 Q All right; Dr. Doblin, at least let me ask
19 you this question: the marijuana that you use for
20 recreational use, is that from, how would I put
21 this, illicit street marijuana, or is it from
22 marijuana that is in the stream of HHS-DEA
0720
1 commerce, lawful marijuana?
2 A I have never used any marijuana that was
3 from NIDA, nor would I want to.
4 [Laughter.]
5 Q Have you ever had the opportunity to visit
6 the University of Mississippi?
7 A No.
8 Q Have you ever had the opportunity to talk
9 to Dr. ElSohly?
10 A Yes.
11 Q Have you talked to him about the quality
12 of his marijuana?
13 A Yes.
14 Q And did he agree with you that it wasn't
15 very good?
16 A No.
17 Q And you're not surprised about that?
18 A No, I'm not surprised about that.
19 Q Now, you've talked about Dr. Russo, and
20 actually, the complaints of the patients in Dr.
21 Russo's article, you recall that?
22 A Yes.
0721
1 Q And do you know if the complaints of those
2 patients were addressed by Dr. ElSohly and the
3 University of Mississippi?
4 A I know that in Dr. ElSohly's letter to the
5 DEA, once they finally published in the Federal
6 Register Dr. Craker's application, he indicated
7 that he had an interest in quality and that now, he
8 was trying to take out the seeds and stems and the
9 sticks from the marijuana that was being provided.
10 Q And do you know if that's happened or not?
11 A I'm not sure if that's happened. I
12 presume it's happened to some degree, but I have
13 not had an occasion to actually examine marijuana
14 from NIDA.
15 Q Dr. Doblin, you would be the one to direct
16 Dr. Craker where to send the marijuana if he gets
17 registered; is that correct?
18 A Yes, I assume that I would never be in
19 physical proximity to the marijuana. I would
20 never--probably might not even, unless DEA approved
21 it, would not even be able to visit the facility.
22 MR. BAYLY: Your Honor, I just need a
0722
1 minute to find, if I may, Respondent's latest
2 supplemental prehearing statement.
3 JUDGE BITTNER: Okay; let's go off the
4 record for a minute.
5 [Pause.]
6 BY MR. BAYLY:
7 Q Dr. Doblin, I just want to ask you a few
8 questions. You testified for Philip Alden; is that
9 correct?
10 A Yes.
11 Q And Philip Alden elected not to come,
12 because he was concerned about disclosing his
13 illegal use of marijuana; is that correct?
14 A No; I think that under California law that
15 his use may indeed have been legal under California
16 law. But I think he was concerned about possible
17 consequences. He was scared to sit here and answer
18 the questions you're asking me.
19 Q So he was concerned about Federal
20 prosecution in light of his illegal use of
21 marijuana under Federal law.
22 A Yes, I think that's fair to say.
0723
1 Q Now, when did Mr. Alden make this
2 complaint about the NIDA marijuana that he was
3 given?
4 A I think it was probably about four years
5 ago.
6 Q Three years ago?
7 A I think it was four years ago.
8 Q And he obtains this marijuana under the
9 compassionate use program.
10 A No, he was in a--
11 Q He was in a clinical study of Dr.
12 Israelski?
13 A Yes, in a clinical study.
14 Q Dr. Israelski himself didn't make a
15 complaint on behalf of Mr. Alden, did he?
16 A Not that I know of, no.
17 Q Now, did you testify that Mr. Alden
18 complained that the NIDA marijuana gave him
19 bronchitis?
20 A Yes.
21 Q Okay; now, did Mr. Alden tell that to you,
22 Dr. Doblin?
0724
1 A Yes, yes, he did.
2 Q He attributed only the NIDA marijuana to
3 his bronchitis.
4 A Only the NIDA marijuana made him sick, of
5 all the experience he's had.
6 Q Now, he had been using marijuana outside
7 of the NIDA marijuana; is that correct?
8 A It's my understanding that he has had
9 occasion to use marijuana that was outside of the
10 NIDA marijuana that he was in the clinical trial
11 using.
12 Q And do you know when he started using this
13 marijuana that was not NIDA marijuana?
14 A No, no, I don't.
15 Q But the marijuana that we're talking
16 about, Dr. Doblin, is marijuana that is grown
17 legally under California law and illegally as far
18 as the Federal Government in Gonzales v. Raich is
19 concerned; would that be correct?
20 A Yes, I would think that.
21 Q And you can't really testify that the
22 bronchitis indeed was caused by the NIDA marijuana
0725
1 or by the other marijuana that Mr. Alden used.
2 A Yes, I can.
3 Q Based on what he said?
4 A Based on what he told me, that the
5 bronchitis was associated with the period of time
6 that he was using the NIDA marijuana in the
7 clinical study; that he had not had bronchitis
8 before or after.
9 Q How do you know it wasn't caused by the
10 other marijuana that he used?
11 A Because he didn't have the bronchitis
12 until he started using the NIDA marijuana
13 exclusively in the context of the clinical study.
14 Q That's what he told you.
15 A That's what he told me.
16 Q Did you confirm that with Dr. Israelski?
17 A No.
18 Q Did you confirm that with Mr. Alden's
19 family practitioner or any physician?
20 A No, no.
21 JUDGE BITTNER: So, Dr. Doblin, your
22 premise is that while Mr. Alden was in Dr.
0726
1 Israelski's study, he used only the NIDA marijuana
2 and no other.
3 THE WITNESS: Yes, that is my
4 understanding. That's what you're asked to do when
5 you're in a clinical study, to use only those
6 supplies, and I believe that that was what he
7 complied with.
8 JUDGE BITTNER: Okay.
9 BY MR. BAYLY:
10 Q Dr. Doblin, did Mr. Alden indicate to you
11 that while he was using the NIDA marijuana he also
12 used marijuana from the California, the other
13 source?
14 A No, he indicated to me that while he was
15 using the NIDA marijuana, he was only using the
16 NIDA marijuana.
17 Q Now, did he then indicate to you that he
18 on his own switched to the marijuana, I'll call it
19 the other source; you know what I'm talking about.
20 Did he indicate that he used marijuana from another
21 source.
22 A Yes.
0727
1 Q And another source we define as legal
2 under California, illegal under Federal law.
3 A Yes.
4 Q And how long did he use that marijuana?
5 Do you know?
6 A He didn't tell me that.
7 Q Do you know how often he used that
8 marijuana?
9 A No, I don't know that.
10 Q Do you know the THC level of the marijuana
11 that he used under NIDA?
12 A I think it was probably around 4 percent
13 THC, 3 to 4 percent THC.
14 Q And where do you get that number? Why do
15 you conclude that?
16 A Because I've looked closely at what NIDA
17 has had available, what they've provided for
18 clinical studies. I know that NIDA now has a
19 maximum of 7 percent potency marijuana, that Dr.
20 ElSohly has responded to complaints, as has NIDA,
21 about their low potency product and that they have
22 made a point of trying to make higher potency
0728
1 marijuana available. I think at the time of the
2 study, that the marijuana was probably 3 to 4
3 percent THC.
4 Q And that was three years ago?
5 A I think that was about four years ago.
6 Q Four years ago?
7 A Mm-hmm.
8 Q Can you tell us about when Mr. Alden
9 informed you that he developed bronchitis?
10 A Well, I spoke to him last week. I had
11 spoken to him prior to that, but most recently last
12 week.
13 Q Okay; you spoke to him last week, and
14 maybe the question wasn't that clear. Did he tell
15 you when he developed bronchitis?
16 A Yes, he told me that he developed
17 bronchitis while he was in the clinical study
18 taking the NIDA marijuana.
19 Q And to your knowledge, he's still smoking
20 marijuana, though.
21 MS. CARPENTER: Objection; relevance.
22 Beyond the scope of his direct examination.
0729
1 JUDGE BITTNER: Sustained. I don't see
2 what difference that makes.
3 MR. BAYLY: Well, Your Honor, I think I
4 want to find out--I think Dr. Doblin already did
5 testify that Mr. Alden explained to him that he was
6 using marijuana from another source, so let me
7 withdraw that question and ask you this, Dr.
8 Doblin:
9 BY MR. BAYLY:
10 Q Did Mr. Alden indicate to you that he
11 still has bronchitis?
12 A He indicated that he does not have
13 bronchitis.
14 Q So did the bronchitis, then, go away as
15 soon as Mr. Alden--did he indicate to you that the
16 bronchitis ceased to exist as soon as he started
17 using another source of marijuana?
18 A He indicated to me that the bronchitis
19 went away as soon as he stopped using the NIDA
20 marijuana or shortly thereafter.
21 Q And did he ever indicate to you that it
22 resumed at any time, the bronchitis?
0730
1 A He's indicated to me that he's never had
2 it since.
3 Q So he said he's never had it since.
4 A Right.
5 Q When did he tell you that?
6 A Last week.
7 Q Now, was Philip Alden taking this--he's
8 got AIDS; is that the issue?
9 A Yes.
10 Q And that means he's got an immune
11 deficiency?
12 A Yes.
13 Q Dr. Doblin, the potency of the NIDA
14 marijuana that was taken by Philip Alden while he
15 was under the research care of Dr. Israelski,
16 wasn't there a protocol for the THC level in that
17 marijuana?
18 A Yes, there was.
19 Q But are you able to say what that THC
20 level is in light of that answer?
21 A I have not seen that exact protocol.
22 MR. BAYLY: If I could have a moment, Your
0731
1 Honor.
2 JUDGE BITTNER: Yes.
3 MR. BAYLY: Thank you.
4 [Pause.]
5 MR. BAYLY: That's all for now. Thank
6 you, Dr. Doblin.
7 JUDGE BITTNER: Redirect?
8 MS. CARPENTER: Would it make sense to
9 take a five minute break?
10 JUDGE BITTNER: Sure; you can even have
11 10.
12 MS. CARPENTER: Oh, thank you, Your Honor.
13 [Recess.]
14 MS. CARPENTER: Thank you, Your Honor.
15 REDIRECT EXAMINATION
16 BY MS. CARPENTER:
17 Q Dr. Doblin, you were asked on cross-examination
18 some questions about whether you
19 thought medical marijuana ought to be available for
20 medical use pending FDA studies. Do you know if
21 it's legal to use marijuana as medicine in some
22 places?
0732
1 A I think it's--
2 MR. BAYLY: Objection; I think it's out of
3 the scope of cross. I don't think we got into
4 that.
5 MS. CARPENTER: I believe there were
6 specific references to whether it was illegal or
7 not.
8 JUDGE BITTNER: I think we did, so I'll
9 allow it. But I think it might be a good idea to
10 get from the witness a definition of the term
11 illegal under the circumstances.
12 BY MS. CARPENTER:
13 Q What's your understanding of the word
14 illegal?
15 [Laughter.]
16 A Well, I guess I would understand it to
17 mean illegal under Federal law or under state or
18 local laws or in other countries.
19 Q Okay; basically against a law.
20 A Against a law.
21 Q Is medical marijuana legal in some places
22 in the United States?
0733
1 A Well, I think there are 10 states where
2 it's legal for patients to use under state law and
3 illegal, now, as the Supreme Court has said, under
4 Federal law. I think there is to the extent that
5 you want to--well, I guess Marinol is, you know,
6 not marijuana; it's THC. That's legal everywhere.
7 In other countries, the Netherlands, they provide
8 marijuana to pharmacies, so it's legal there.
9 Q That's fine. You were also asked some
10 questions about CMCR and MAPS sponsoring, and I
11 believe you were asked a question that was other
12 than CMCR, what researchers are you subsidizing for
13 marijuana research. Does MAPS subsidize CMCR
14 research?
15 A No, we don't. We did collaborate, in a
16 sense with Dr. Donald Abrams on the vaporizer study
17 in that we provided the analytical data to him that
18 he then submitted to FDA as part of his application
19 that CMCR then funded.
20 Q Okay; and you were also asked some
21 questions about the cost of developing
22 pharmaceutical drugs, and I think you said I could
0734
1 explain why I say $5 million to $10 million is
2 reasonable for marijuana or MDMA. Could you
3 explain that a little further?
4 A Yes.
5 Q Why is it a reasonable number?
6 A Yes; I mean, this was a really big part of
7 my dissertation, because I needed to figure out, in
8 a way, if it was an unreasonable or unrealistic
9 goal to try to develop marijuana into a
10 prescription medicine or MDMA into a prescription
11 medicine.
12 And so, I went to Dr. Joe Dimasi, who is
13 the fellow for the Tufts Center for the Study of
14 Drug Development that works for the pharmaceutical
15 industry that developed the estimates of what it
16 costs. And the latest estimate is something like
17 $880 million. And of that $880 million, more than
18 half of it is opportunity cost that they calculate
19 at 12 percent per annum.
20 So you knock off, you know, more than $420
21 million just because of opportunity costs. So
22 those are not expenses that anybody needs to raise.
0735
1 JUDGE BITTNER: Now, when you say
2 opportunity costs, I don't know if I asked the
3 other day.
4 THE WITNESS: Okay.
5 JUDGE BITTNER: Would you like to define
6 how you're using it?
7 THE WITNESS: What I mean is that the
8 money that a pharmaceutical company invests in
9 research, they could just as easily invest it in
10 the stock market or invest it in bonds. And so,
11 they calculate from the first money that they
12 invest in the synthesis of drugs through the whole
13 course of the drug development what profit they
14 could have earned on that money, and they assume 12
15 percent per annum as the appropriate rate of return
16 for pharmaceutical companies.
17 And so, in addition to their cash outlay,
18 it's what money they've foregone that they could
19 have raised by just investing the money somewhere
20 else.
21 JUDGE BITTNER: And compounding it over
22 time.
0736
1 THE WITNESS: Yes.
2 JUDGE BITTNER: So the first $10 million
3 in year one and the $10 million in year two, et
4 cetera.
5 THE WITNESS: Yes, and it could be 15
6 years or so from the time they initially do
7 something to the time they get it through. So more
8 than half of that goes away from opportunity costs.
9 Then, they amortize the costs of all the failures
10 onto the few successes. So that's all the studies
11 that they do that end up being--the drug doesn't do
12 anything, or it's too risky, or there are safety
13 consequences that they find unacceptable.
14 So of the roughly $400 million that's
15 left, more than half of that is gone for the cost
16 of the failures. Then, as Dr. Irwin testified,
17 these large scale studies that are primarily
18 looking at safety in thousands of patients, the
19 advantage that we have as a small nonprofit working
20 with marijuana or working with MDMA is that
21 governments of the world have spent hundreds of
22 millions of dollars looking at the risks of these
0737
1 drugs, and that is then published, and it's in the
2 scientific literature, and then, we can summarize
3 that and submit that to the FDA as part of our risk
4 analysis.
5 So we are fundamentally in a different
6 position that a new drug which, by the time the FDA
7 gets the file, the NDA to look at, only a few
8 thousands of people have used it. With marijuana,
9 tens of millions of people have used it. With
10 MDMA, many, many millions of people have used it.
11 So that for example, with MDMA, there's over 2,000
12 scientific papers in the literature, in the peer
13 reviewed literature.
14 And we have a very good idea of what the
15 risk profile is of these drugs. With marijuana,
16 there's been hundreds and hundreds of millions of
17 dollars spent on the risks so that we don't need to
18 replicate all those studies about the genetics, you
19 know, the effect on reproduction, the effect on all
20 sorts of bodily systems. There is just an enormous
21 body of evidence about safety that's out there that
22 we don't need to replicate.
0738
1 What we primarily need to do is look at
2 the use of marijuana in a specific patient
3 population that then, we see what are the risks in
4 that particular patient population at the same time
5 that we're assessing efficacy. So the chances are
6 by the time that we go from the first study to the
7 final study, we've tested 500 or 600 people. I
8 think we can develop the data sufficient to provide
9 information to FDA about marijuana's medical use on
10 the basis of 500 or 600 subjects.
11 And then, when you look at what the cost
12 is, the costs for the pharmaceutical industry are,
13 you know, they have a much higher overhead; they
14 have much higher expenses. They have a whole set.
15 We get a lot of donated labor, meaning that
16 researchers work for nonprofits for a fraction of
17 what they might charge others, so that we're
18 estimating somewhere in the neighborhood of around
19 $10,000 per subject per clinical trial.
20 And so, based on that, it seems to me that
21 it's within the range of $5 million to $10 million.
22 And when you look at the amount of resources that
0739
1 have gone into these state medical marijuana
2 initiatives and legislative actions, we're in
3 excess of $15 million. So I think that it will be
4 possible to raise the necessary money and conduct
5 the kind of studies that FDA would want.
6 The other thing to say is that the actual
7 number of subjects depends on two factors. One is
8 what is called the effect size, which is how strong
9 the clinical effect is. So the stronger the effect
10 is, the easier it is to see, if it's a mild effect,
11 a small reduction in pain or whatever. So the
12 effect size is one factor, and then, the other is
13 the variability. If it sort of works for
14 everybody, then, it's easier to see statistically;
15 if it works for 20 percent of the people but not
16 for 80 percent, then, it is a harder thing to see,
17 and then, you need to use a larger number of
18 subjects.
19 So when you look at what we estimate would
20 be effect size and variability, and we won't know
21 those for sure until we do the initial pilot
22 studies. But at this point, I think that it's $5
0740
1 million to $10 million, and I think that's a
2 reasonable estimate and one that's within the range
3 of what we can raise.
4 We have some very wealthy donors that
5 could donate that amount of money if they felt that
6 we were on a track towards FDA approval. So I
7 think it's not an unrealistic situation that we're
8 involved in.
9 BY MS. CARPENTER:
10 Q Dr. Doblin, you were also asked some
11 questions about whether you would be directing who
12 would get the marijuana that Dr. Craker would grow
13 should the application be granted. And I think you
14 answered yes, but you had never had it. How would
15 that process work of MAPS identifying sponsors, and
16 then, how would they get the marijuana that they--
17 A Well, should we get a license for
18 Professor Craker's facility, we would then work
19 with FDA on this clinical plan. We would come up
20 with what our strategy was for the development of
21 marijuana for a particular clinical indication.
22 And then, we would try to find researchers who
0741
1 would be willing to do those sorts of studies.
2 And then, once we found those researchers,
3 and they had the appropriate protocols approved,
4 then, we would say we have this supply here, and
5 then, this is where the marijuana needs to go. And
6 then, Professor Craker would ship it to whatever
7 researcher was going to receive it with the
8 appropriate DEA Form 222, and that would be the way
9 it would be done.
10 Q You were also asked some questions about
11 Mr. Alden and his participation in the clinical
12 study with Dr. Israelski, and you were asked
13 whether Dr. Israelski complained about the
14 marijuana to your knowledge, the NIDA marijuana.
15 Do you know, did Mr. Alden tell you anything about
16 what Dr. Israelski told him?
17 A Yes, Phil Alden told me that Dr. Israelski
18 advised him to leave the study, that it would be in
19 his best safety interests or the interests of his
20 health if he were to withdraw from the study.
21 MS. CARPENTER: Your Honor, I think that's
22 all we have.
0742
1 JUDGE BITTNER: Recross?
2 MR. BAYLY: Yes, thank you, Judge Bittner.
3 RECROSS EXAMINATION
4 BY MR. BAYLY:
5 Q Dr. Doblin, you testified just now that
6 Mr. Alden said that Dr. Israelski advised him to
7 leave the study; is that right?
8 A Yes.
9 Q And that's what Mr. Alden told you.
10 A Right.
11 Q But you didn't confirm that with Dr.
12 Israelski.
13 A No, I did not.
14 Q You indicated that there was somebody who
15 helped you with a market analysis? Is that right?
16 A Market analysis? Clinical plan? I'm not
17 sure what you mean.
18 MR. BAYLY: I'm sorry; maybe I'm mistaken.
19 JUDGE BITTNER: Are you talking about the
20 cost of developing a drug?
21 MR. BAYLY: Yes.
22 JUDGE BITTNER: Okay.
0743
1 BY MR. BAYLY:
2 Q Was there somebody who helped you?
3 A Oh, where this $880 million number comes
4 from?
5 Q Yes.
6 A Okay, it comes from a Dr. Joe Dimasi, and
7 he just explained to me where the number comes
8 from. I mean, he's written papers on it in the
9 literature.
10 Q How do you spell his last name?
11 A D-I-M-A-S-I. And he's the one who works
12 for the Tufts Center for the Study of Drug
13 Development, and they're the ones who come up with
14 these estimates. They're the same estimates that
15 Dr. Irwin was--
16 Q When did you contact him, Dr. Doblin?
17 A When I was working on my dissertation.
18 Q What year was that?
19 A So it was 2000, like 2000.
20 Q Around 2000?
21 A Yes, yes, 1999, 2000.
22 JUDGE BITTNER: I'm sorry; would you spell
0744
1 Dr. Dimasi's name again?
2 THE WITNESS: D-I-M-A-S-I.
3 JUDGE BITTNER: Okay.
4 BY MR. BAYLY:
5 Q And Dr. Doblin, you were asked about the
6 legality of marijuana in various jurisdictions,
7 but, I mean, it's your understanding that using
8 marijuana for other than medical uses is even
9 illegal under all the state law; is that correct?
10 A Yes, yes.
11 MR. BAYLY: Thank you; that's all I have.
12 JUDGE BITTNER: Any re-redirect?
13 MS. CARPENTER: No, thank you.
14 JUDGE BITTNER: Okay; Dr. Doblin, you're
15 through. Thank you.
16 [Witness excused.]
17 JUDGE BITTNER: Ms. Carpenter, what would
18 you like to do now?
19 MS. CARPENTER: Your Honor, we are done.
20 JUDGE BITTNER: Except for Dr. Abrams.
21 MS. CARPENTER: Except for Dr. Abrams, who
22 will be here in September; that is correct.
0745
1 JUDGE BITTNER: Okay; are there any
2 exhibits that you would like to proffer now that
3 you haven't?
4 MS. CARPENTER: Yes, Your Honor; there was
5 a letter, there was discussion yesterday about a
6 letter to Dr. Leschner--all these doctors again--from Dr.
7 Craker to the DEA, and it was attaching
8 the letters.
9 JUDGE BITTNER: Oh, yes.
10 MS. CARPENTER: And we had one attachment
11 yesterday, and we have the second attachment today,
12 which is also not signed, so we had this problem
13 because I think doctors don't think like lawyers,
14 that they'll actually need these papers later. So
15 the copies they send out to other people interested
16 in their correspondence are--
17 JUDGE BITTNER: Why don't you show it to
18 Mr. Bayly and see where we go from that?
19 MS. CARPENTER: He's already seen it. I
20 gave it to him this morning.
21 JUDGE BITTNER: Okay.
22 MS. CARPENTER: So--
0746
1 JUDGE BITTNER: And I can't remember which
2 exhibit this was the attachment to.
3 MS. CARPENTER: Yes, let me figure that
4 out.
5 [Pause.]
6 MS. CARPENTER: It was an attachment to
7 Government's Exhibit No. 30. I think we made the
8 first letter, which would be from--or the newspaper
9 article became Exhibit No. 30A.
10 MR. BAYLY: Right.
11 MS. CARPENTER: And then, this would be
12 30B.
13 JUDGE BITTNER: 30B.
14 MR. BAYLY: Do you have another copy,
15 Julie?
16 MS. CARPENTER: I gave you my copy this
17 morning.
18 MR. BAYLY: Okay.
19 JUDGE BITTNER: And this is a two-page
20 document.
21 MR. BAYLY: We do.
22 MS. CARPENTER: And again, this would just
0747
1 complete that as the document that was originally
2 sent.
3 JUDGE BITTNER: Okay; so I gather, Ms.
4 Carpenter, that you are offering Government Exhibit
5 No. 30B.
6 MS. CARPENTER: We are, as we did
7 Government 30 and 30A.
8 JUDGE BITTNER: Okay; Mr. Bayly, any
9 objection?
10 MR. BAYLY: No.
11 JUDGE BITTNER: Okay; received.
12 [Government Exhibit No. 30B
13 was marked for identification
14 received in evidence.]
15 MS. CARPENTER: We also checked during the
16 break today, Your Honor. Let me just check my
17 notes.
18 This was Exhibit No. 12, Your Honor.
19 JUDGE BITTNER: Your Exhibit No. 12?
20 MS. CARPENTER: Yes, Respondent's Exhibit
21 No. 12. That was the letter where the FDA granted
22 the orphan drug designation.
0748
1 JUDGE BITTNER: Oh.
2 MS. CARPENTER: And it was unsigned.
3 JUDGE BITTNER: Right.
4 MS. CARPENTER: We had checked the
5 Website, and it does have a signed copy. I don't
6 know why the copy I have was cut off, but we'll
7 bring that in tomorrow.
8 JUDGE BITTNER: Okay.
9 MS. CARPENTER: And we can clear that up.
10 JUDGE BITTNER: Okay; so everything else
11 either it's in, or I excluded it in the response to
12 the ruling on the motion in limine, or you're not
13 ready to offer it yet.
14 MS. CARPENTER: That is correct, Your
15 Honor.
16 JUDGE BITTNER: Okay.
17 MS. CARPENTER: I hope that's correct.
18 JUDGE BITTNER: Okay; well, if it's not,
19 we can resolve it. So, you're on temporary hold.
20 Mr. Bayly, do you wish to start your case-in-chief?
21 MR. BAYLY: Judge Bittner, I guess the
22 case has kind of whittled down more than we
0749
1 expected. We found out awhile ago, Donald Abrams
2 was not coming, and he will be here in September,
3 but then, we found is it Dr. Lilly--and then, Mr.
4 Alden and now Mr. Irv Rosenfeld.
5 MS. CARPENTER: Right; Mr. Rosenfeld was
6 to be here today and decided it was not in his best
7 interests. He's one of the compassionate use
8 patients.
9 JUDGE BITTNER: Okay.
10 MS. CARPENTER: He had some concerns about
11 testifying about--
12 JUDGE BITTNER: Okay; so he's not going to
13 testify at all.
14 MS. CARPENTER: So he's not going to
15 testify at all.
16 JUDGE BITTNER: Right.
17 MS. CARPENTER: As we told the Government
18 this morning, we found out last night.
19 JUDGE BITTNER: Okay; so, I guess I've got
20 two queries for you, Mr. Bayly: do you have any
21 witnesses you want to start with today and--
22 MR. BAYLY: We'd like to start tomorrow if
0750
1 we could. We also note that Dr. Grundspun is not
2 coming either so--
3 JUDGE BITTNER: Not at all?
4 MS. CARPENTER: No, no, that's right. His
5 testimony had been largely excluded so--
6 JUDGE BITTNER: Right.
7 MS. CARPENTER: So he didn't feel it was
8 worthwhile to come for a little bit.
9 JUDGE BITTNER: Then, my next question,
10 Mr. Bayly, is do you want to give your opening
11 statement today?
12 MR. BAYLY: I'm not prepared to do that
13 either because--
14 JUDGE BITTNER: Okay; you don't have to.
15 I was just asking.
16 MR. BAYLY: I just thought we would kill
17 the day easily.
18 JUDGE BITTNER: Well, it's not that early.
19 So all right; so is there a consensus--I always
20 like to get consensus among the adversaries--that
21 we should quit for the day now?
22 MR. BAYLY: Certainly.
0751
1 MS. CARPENTER: I would join in that
2 consensus, Your Honor.
3 JUDGE BITTNER: Okay; shall we start at
4 9:00 tomorrow morning? Yes; 9:00 tomorrow morning.
5 MS. CARPENTER: That would be fine.
6 JUDGE BITTNER: Mr. Bayly, is that okay
7 with you?
8 MR. BAYLY: That's fine.
9 JUDGE BITTNER: Ms. Carpenter, I don't
10 show that you offered the single convention.
11 MS. CARPENTER: No, we have not, Your
12 Honor.
13 JUDGE BITTNER: Okay.
14 MS. CARPENTER: And there are probably
15 some others, because I understood we had to submit
16 what we were going to use, whether it was cross or
17 direct, so there are several things, I think,
18 that--
19 JUDGE BITTNER: Okay; that's fine. I just
20 wanted to make sure I hadn't missed something.
21 MS. CARPENTER: I appreciate that.
22 JUDGE BITTNER: In that case, I will see
0752
1 you all at 9:00 tomorrow morning. Have a nice
2 evening.
3 [Whereupon, at 3:52 p.m., the hearing was
4 recessed, to reconvene on Thursday, August 25,
5 2005, at 9:00 a.m.]
6 - - -