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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 i