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4 :
In the Matter of: :
5 :
LYLE E. CRAKER, Ph.D. : Docket No. 05-16
6 :
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9 Wednesday, December 14, 2005
10 DEA Headquarters
11 600 Army Navy Drive
12 Hearing Room E-2103
13 Arlington, Virginia
15 The hearing in the above-entitled matter
17 convened, pursuant to notice, at 9:06 a.m.
22 Chief Administrative Law Judge
2 On Behalf of the DEA:
Office of Chief Counsel
4 Drug Enforcement Administration
Washington, D.C. 20537
6 Senior Attorney
Office of Chief Counsel
7 (202) 353-9676
On Behalf of the Respondent:
10 Jenner & Block LLP
601 13th Street, N.W.
11 Suite 1200 South
Washington, D.C. 20005
12 (202) 661-4810
Senior Staff Attorney
14 Drug Reform Project
American Civil Liberties Union Foundation
15 1101 Pacific Avenue, Suite 333
Santa Cruz, California 95060
16 (831) 471-9000 Ext. 14
19 Representative of the Government
22 Representative of Respondent
1 C O N T E N T S
3 Steven W. Gust 5 23 120 125
- - -
No. 24 -- 11
9 No. 34 -- 73
No. 4 -- 143
10 No. 26 -- 147
No. 27 -- 148
11 No. 31 -- 151
No. 32 -- 152
12 No. 33 -- 153
No. 35 -- 155
13 No. 44 -- 159
No. 45 -- 160
14 No. 47 -- 163
No. 49 -- 164
15 No. 52 -- 165
No. 55 -- 171
16 No. 62 -- 173
No. 64 -- 178
17 No. 82 -- 179
No. 83 -- 180
18 No. 84 -- 181
Nos. 92 and 92A -- 184
22 none
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. Mr. Bayly?
3 MR. BAYLY: We are going to call Dr. Steve
4 Gust, and we can get him done, and then talk about
5 scheduling for tomorrow.
6 I guess I should let you know, Judge
7 Bittner, and respondent's counsels, I think I may
8 have mentioned yesterday that Dr. Auslander, his
9 train is supposed to come in at 9:45.
10 JUDGE BITTNER: Tomorrow.
11 MR. BAYLY: Tomorrow.
12 JUDGE BITTNER: In the sleet?
13 MR. BAYLY: Well, and Amtrak, from my
14 experience, is not good in inclement weather, so we
15 could start in the morning perhaps, or go through
16 the exhibits, or maybe this afternoon, whatever the
17 Court and respondent's counsels prefer is okay with
18 me, but we may be starting fairly late in the
19 morning with Dr. Auslander.
20 That said, his testimony will be I think
21 the shortest by far definitely of all the
22 witnesses, so there isn't any question that we'll
1 get done with him thursday. The question is when
2 we'll start with him.
3 JUDGE BITTNER: Well, let's see what
4 happens today and then we'll sort it out.
5 So are you ready to call Dr. Gust?
6 MS. PAREDES: Yes, Your Honor. The
7 government's going to call Dr. Steven Gust.
8 JUDGE BITTNER: If you would please come
9 right up here. Good morning. And if you would
10 stand and raise your right hand.
11 Whereupon,
13 was called as a witness herein, and having been
14 duly sworn, was examined and testified as follows:
17 Q Good morning, sir. Would you please state
18 your name, spelling your last?
19 A Steven W. Gust, G-u-s-t.
20 JUDGE BITTNER: And would you spell your
21 first name too, please?
22 THE WITNESS: Steven with a V.
1 JUDGE BITTNER: Thank you.
3 Q And your highest level of education?
4 A Ph.D.
5 Q And, Dr. Gust, what is your current
6 position with the Federal Government?
7 A I'm Special Assistant to the Director at
8 the National Institute on Drug Abuse.
9 Q And would that commonly be referred to as
10 NIDA?
11 A Yes, NIDA.
12 Q And how long have you held this position?
13 A Since 1990.
14 Q Could you please explain where NIDA fits
15 within the structure of the Department of Health
16 and Human Services?
17 A Sure. The Department of Health and Human
18 Services has several large agencies, including the
19 FDA and the NIH, the National Institutes of Health.
20 There are 27, I think, at last count, separate
21 institutes and centers within--that comprise the
22 NIH as a whole, and NIDA is one of those 27.
1 Q So can you explain then where's the
2 relationship between NIDA and NIH?
3 A NIDA is one of the components of NIH.
4 Q Can you explain what NIDA's mission is?
5 A NIDA's mission is to support research on
6 the causes, consequences, prevention and treatment
7 of drug abuse and drug addiction.
8 Q Does it also administer the National Drug
9 Supply Program?
10 A Yes, it does.
11 Q Can you explain how NIDA administers that
12 program?
13 A Well, the National Drug Supply Program
14 provides research materials to researchers. These
15 tend to be scheduled drugs, scheduled substances or
16 their precursors. In general that's it. Do you
17 want me to go into details about how it works or--
18 Q No. When you say scheduled drugs, do you
19 mean Schedules I through V, or just Schedule I?
20 A Yeah. Pretty much all scheduled drugs and
21 some nonscheduled drugs as well.
22 JUDGE BITTNER: But scheduling, referring
1 to Federal schedule--
2 THE WITNESS: --under the Controlled
3 Substances Act, yes.
5 Q Can you explain the process by which NIDA
6 distributes marijuana?
7 A Requests for marijuana for research come
8 to NIDA, to our Drug Supply Program, at which point
9 there are three things that need to happen. First
10 of all, there needs to be a peer review for
11 scientific merit of the research proposal.
12 Secondly, there needs to be a registration with the
13 Drug Enforcement Agency. And thirdly, there needs
14 to be investigational new drug application filed
15 with the FDA.
16 Once those three things have occurred,
17 there is an ordering process where an investigator
18 submits an order form--I believe it's a DEA form--to NIDA,
19 and the order's filled.
20 Q Now, that process that you just described,
21 does that apply to all requests for marijuana
22 regardless of funding?
1 A Yes, it does.
2 Q Now, are those three requirements unique
3 to specifically marijuana researchers or does that
4 apply across the board?
5 A It applies across the board for any
6 substances that are provided by NIDA to the Drug
7 Supply Program.
8 Q Now, I want to point your attention to the
9 peer review for scientific merit. When you use the
10 term "peer review," what are you referring to?
11 A Peer review is a process that has been
12 used, certainly by NIH, and I think in other
13 agencies in Department of Health and Human
14 Services, and probably the Federal Government,
15 where outside expertise is acquired and outside
16 opinions on the scientific merit of specific
17 research proposals.
18 Q When you refer to outside expertise, are
19 you referring to outside NIH or outside HHS, or
20 what exactly are you referring to?
21 A For the most part it's outside government.
22 The NIH system is the one I'm most familiar with,
1 and there are established peer review committees
2 that are set up that review proposals three times a
3 year for the NIH, and there are--occasionally a
4 Federal employee participates in one of those
5 reviews, but probably 90 percent or more of the
6 participants are researchers who are in the private
7 sector, for the most part in academic institutions.
8 MS. PAREDES: I'd like the witness to be
9 shown what's been marked as Government Exhibit 24.
10 It has not been admitted yet.
11 MR. BAYLY: May I approach, Your Honor?
13 MS. PAREDES: I'll state for the record
14 that Government Exhibit 24 that has been handed to
15 the witness, does have some highlights in it, and
16 that was unintentional.
17 JUDGE BITTNER: I'm sorry? It has some
18 highlights in it and?
19 MS. PAREDES: It was unintentional.
20 JUDGE BITTNER: Okay. You not offering
21 the highlights.
22 MS. PAREDES: Correct.
2 Q Dr. Gust, do you recognize this document?
3 A Yes.
4 Q Can you describe what it is?
5 A This is an announcement that was made in
6 1999 of the Department of Health and Human Services
7 policies and procedures regarding providing
8 marijuana for research on medical, to medical
9 aspects or medical uses of marijuana.
10 Q And to your knowledge, has this document
11 or this policy contained within this document,
12 hasn't been changed or altered since May 21st,
13 1999?
14 A No.
15 MS. PAREDES: Your Honor, the government
16 offers Government Exhibit 24 into evidence.
17 MR. HOPPER: No objection.
18 JUDGE BITTNER: Received.
19 [Government's Exhibit No. 24
20 received in evidence.]
22 Q Dr. Gust, would you explain what was the
1 necessary peer review for medical marijuana
2 researchers before May 21st, 1999, when this
3 exhibit was published?
4 A The peer review was provided through one
5 of two means. First of all, if a researcher was
6 requesting government funding, that is, through NIH
7 or--through NIH, the peer review would be provided
8 by one of the standing peer review committees at
9 NIH. If the researcher had other sources of
10 funding, NIDA would, the normal course of events,
11 get outside experts, generally two or three outside
12 experts, to do an ad hoc review of the scientific
13 merit of the proposal.
14 Q With regard to the scientific merit of the
15 proposal, are you familiar with the pre-1999
16 guidance?
17 A Well, in general, I think the review
18 criteria--is that what you're asking me about?
19 Q Yes.
20 A In terms of--they may have changed
21 somewhat over the years, but in general there are
22 several kind of criteria that are used. First of
1 all, the significance of the project, what's the
2 scientific significance? Is it going to advance
3 scientific knowledge? The approach, what is the
4 particular approach that the researchers are using?
5 Is it a valid approach? Is it one that's going to
6 provide the data that the researcher thinks it's
7 going to provide? Innovativeness, I think, is
8 another criterion. Is the research new and
9 different, or is it repeating something that's been
10 done in the past? The quality and qualifications
11 of the investigators are also part of the review
12 criterion, and also the research environment,
13 whether or not the facilities themselves are
14 adequate for conducting the proposed research.
15 In addition, researchers also have to
16 provide evidence that their proposals have been
17 reviewed and approved for human subjects' concerns
18 and issues, which tends to be a university based
19 process, but they have to provide evidence that
20 there are no human subjects' issues. And I think
21 that those criterion have been pretty much the same
22 pre and post 1999. There may have been a few
1 little modifications over the years, but in general
2 that's what they are.
3 Q Now, the pre-1999 process that you've just
4 described, did that apply to other controlled
5 substances as well as marijuana?
6 A Yes.
7 Q Now, would you explain what this
8 Government Exhibit 24, what this implemented as far
9 as the medical marijuana research from the National
10 Drug Supply?
11 A I'm sorry. I missed part of your
12 question.
13 Q Would you explain what this document,
14 Government Exhibit 24, what this changed in terms
15 of the National Drug Supply Program?
16 A Right. It was about this time when there
17 was some increased interest in research, in
18 pursuing the medical use of marijuana, and in an
19 effort to make the process more standardized, and
20 to basically provide some expertise that did not
21 really exist at NIDA in terms of reviewing
22 applications that involved primarily the use of
1 marijuana or any other substance for that matter
2 for treatment of diseases, which did not really
3 fall within NIDA's mission, the department
4 established a separate peer review process that
5 made the review--that moved the review into the
6 Public Health Service at the time where additional
7 expertise from other NIH Institutes and other
8 Federal agencies could be brought to bear to help--and help
9 provide reviews, appropriate reviews, of
10 the scientific merit of these applications.
11 I believe the other thing that this policy
12 changed was there was a provision that the
13 marijuana wouldn't be provided on a cost-reimbursable basis,
14 in other words, that marijuana
15 provided to projects that were outside of the NIH
16 system would need to reimburse the NIDA contractor
17 for the cost of the marijuana.
18 Q Dr. Gust, are you aware of where the
19 Public Health Service falls within the Department
20 of Health and Human Services structure?
21 A At the time it was a separate agency of
22 the Department of Health and Human Services, and
1 since that time I believe it's been subsumed into
2 the Office of the Secretary of the Department of
3 Health and Human Services.
4 Q To your knowledge, is the Public Health
5 Service--what is the relationship of the Public
6 Health Service to NIDA?
7 A It's--the Public Health Service is part of
8 the direct Office of the Secretary of the
9 Department of Health and Human Services, and so
10 NIDA is, I guess you'd say, several levels below
11 that in the hierarchy of the department.
12 Q With regard to Government Exhibit No. 24,
13 does this policy change apply to the request for
14 marijuana in all research, or does it limit the
15 circumstances in which cases will be referred to
16 the PHS committee?
17 A It really applies just to applications to
18 do research on medical applications of marijuana in
19 human patients, or research that would be relevant
20 to the application--or relevant to the use of
21 marijuana in a medical application.
22 So what it excludes are sort of basic
1 research studies, some animal research, for
2 example, or research in normal human volunteers,
3 that is, healthy human volunteers looking at other
4 aspects of the effects of marijuana, such as
5 effects on performance and memory and so forth and
6 so on. Those would not go to the PHS committee.
7 Q Would those types of projects be otherwise
8 reviewed?
9 A Absolutely. We would all get a peer
10 review--either through the NIH peer review system
11 or through the still-existing ad hoc system that
12 NIDA does use for the occasional application that
13 comes in that does not have Federal--that has
14 funding other than a Federal source, but is not
15 medical marijuana research.
16 Q Also, Dr Gust, in the administration of
17 your duties with NIDA, you also oversee the NIDA
18 contract with University of Mississippi?
19 A Yes.
20 Q Do you know when NIDA began privately
21 contracting cultivation of marijuana?
22 A To my knowledge, NIDA actually inherited
1 the contract to provide the provision of marijuana
2 from an agency that predated NIDA's existence, so
3 that we have had this contract since NIDA's
4 inception in 1973 or '74.
5 Q And generally are you familiar with the
6 requirements of the contract?
7 A Yes.
8 Q To your knowledge, since you've been with
9 NIDA in 1990, have these requirements always been
10 similar?
11 A Yes.
12 Q Are you familiar with the process by which
13 the contract is awarded?
14 A In general, yes.
15 Q Can you explain what, in general terms,
16 how the contract is awarded?
17 A There's a statement of work that's
18 developed by the program staff, actually, myself
19 and Dr. Hari Singh are the two principals involved
20 in that, and other NIDA staff. Basically draft a
21 statement of work which outlines the work that
22 needs to be accomplished. That statement of work
1 is then put into a request for proposal, and
2 submitted to our Contracts Procurement Office,
3 which announces the availability of this contract,
4 receives applications, conducts the review.
5 There's also a review done of all contract
6 proposals, as well as grant proposals. The
7 contracts are rated on criteria similar to what
8 research grants are. They're a little bit
9 different.
10 The review is conducted by a group, again,
11 of outside experts, and applications and applicants
12 that are reviewed within the technically acceptable
13 range are then reviewed on cost, and all
14 applications that are deemed technically acceptable
15 and within the cost estimates are negotiated with
16 by the Contracts Office, and then the application
17 for the proposal that has the best cost--or the
18 lowest cost and the best technical scores are
19 awarded the contract.
20 Q Now, Dr. Gust, are you personally involved
21 in selecting the winner, so to speak, of the
22 contract?
1 A No, that's done by the Contracts Office.
2 Q Is there a contract in place today?
3 A Yes, there is.
4 Q And you're familiar with who won that
5 contract?
6 A Yes.
7 Q Do you know when it was awarded?
8 A March of 2005.
9 Q Was the process to award the contract in
10 place today, was that process followed as you've
11 just described?
12 A Yes.
13 Q Do you know where the contract was
14 advertised?
15 A I believe it was advertised in Commerce
16 Business Daily, and is it Federal Business Ops, Fed
17 Bus Ops.
18 Q Now, are you aware of Dr. Lyle Craker of
19 the University of Massachusetts?
20 A Yes.
21 Q Do you recall how you're aware of him?
22 A I believe I became aware of Dr. Craker at
1 the time of one of his filings with the DEA?
2 Q How was it that it came to your knowledge?
3 A I believe I was contacted by the DEA.
4 Q And have you ever had any direct contact
5 with Dr. Craker?
6 A Not personally, no.
7 Q And otherwise have you had any contact
8 with him?
9 A Only indirectly through requesting that he
10 be notified of the last competition for this
11 contract.
12 Q And would you explain what you did in
13 regards to notifying Dr. Craker?
14 A I asked our Contracts Office to send Dr.
15 Craker the information on the notice in the Fed Bus
16 Ops, that this contract was available.
17 Q And to your knowledge, was that sent to
18 Dr. Craker?
19 A Yes.
20 Q Let's turn our attention now to NIDA's
21 receipt of complaints regarding marijuana. Have
22 you, are you aware of any time or any instance that
1 NIDA received a complaint from qualified
2 researchers, doctors or patients about the quality
3 of the marijuana?
4 A Only what I've read in the papers. I am
5 not aware of any formal written complaints.
6 Q And has anyone, any researchers, doctors
7 or patients, ever called you by telephone to notify
8 you of any complaints?
9 A Not to my recollection, no.
10 MS. PAREDES: May I just have a moment,
11 please?
13 [Pause.]
14 MS. PAREDES: Nothing further, Your Honor.
15 JUDGE BITTNER: Mr. Hopper.
16 MR. HOPPER: May we have a few minutes,
17 Your Honor, to confer, say 10 minutes?
18 JUDGE BITTNER: Okay. Off the record, 10
19 minutes.
20 [Recess at 9:29 a.m.]
21 JUDGE BITTNER: On the record. Mr.
22 Hopper.
1 MR. HOPPER: Thank Your Honor.
4 Q Good morning, Dr. Gust.
5 A Good morning.
6 Q My name's Allen Hopper. I'm one of the
7 attorneys representing Dr. Craker in these
8 proceedings. You probably have figured that out.
9 I am just going to be asking you a few questions
10 this morning about your testimony.
11 You talked to us about the--about NIDA's
12 mission. Isn't it true that it's not NIDA's
13 mission to study the medicinal uses of marijuana or
14 advocate for the establishment of facilities to
15 support such research?
16 A Yes.
17 Q You told us that NIDA provides marijuana
18 that's grown by Dr. El Sohly at the University of
19 Mississippi to researchers as part of NIDA's Drug
20 Supply Program, right?
21 A Yes.
22 Q And you said that the University of
1 Mississippi grows that marijuana through a contract
2 that it was awarded through a competitive bid
3 process; is that right?
4 A Yes.
5 Q Do you know, has any other person or
6 entity ever submitted a proposal in response to the
7 RFP for that contract?
8 A Yes.
9 Q Other entities have?
10 A Yes.
11 Q And can you tell me who those other
12 entities were?
13 A I don't know.
14 Q Can you tell me how many other entities
15 have responded?
16 A Well, as you know, those contracts have
17 been reissued several times over the last 25 or 30
18 years.
19 Q Right.
20 A Generally in three to five year cycles. I
21 can't tell you any specific name of an offeror
22 other than the University of Mississippi, or
1 Research Triangle Institute off the top of my head.
2 I haven't been involved in the process that long
3 myself. I've only been involved since probably one
4 round before this current round in terms of the
5 contract procurement. And I believe for the last
6 one there was several offerors, actually more than
7 two, but I can't remember their names.
8 Q And are you aware of whether or not other
9 persons or entities have submitted proposals prior
10 to your becoming involved in this process?
11 A Yes.
12 Q Would you just give us a ballpark estimate
13 of--are we talking, you know, five, a dozen?
14 A I really don't know.
15 Q You told us also that NIDA makes available
16 for researchers other Schedule I drugs besides
17 marijuana through its Drug Supply Program?
18 A Yes.
19 Q But aren't there also alternative supplies
20 outside of NIDA's program of other Schedule I drugs
21 besides marijuana that are made available to
22 researchers?
1 A Yes. For some Schedule I substances, yes.
2 Q But NIDA's the sole supplier of marijuana?
3 A Yes. And I think other, many other
4 Schedule I substances as well, NIDA's the only
5 supplier.
6 Q Can you tell me what those other
7 substances are?
8 A I can't off the top of my head, but there
9 are probably 50 to 100 different substances in
10 NIDA's Drug Supply Program in Schedule I, and I
11 think only a handful of those are available from
12 other sources.
13 Q So do you know whether cocaine, for
14 instance, is available from other sources?
15 A Yes, but that's not a Schedule I
16 substance.
17 Q Cocaine is Schedule II.
18 A Right.
19 Q Do you know whether LSD is a Schedule I
20 substance?
21 A That is a Schedule I substance.
22 Q Is that available from other sources?
1 A I believe it is. I'm not positive, but I
2 believe it is.
3 Q And are you familiar with the drug MDMA,
4 also known as Ecstasy?
5 A Yes.
6 Q Is that drug available from other sources?
7 A I believe it is, but I'm not positive.
8 Q Are you familiar with the drug psilocybin?
9 A Yes.
10 Q Is that a Schedule I substance?
11 A Yes.
12 Q Is that available from other sources other
13 than--
14 A I don't know.
15 Q Are you familiar with the Schedule I drug
16 mescaline?
17 A Yes.
18 Q Do you know if that's available from other
19 sources?
20 A I don't know.
21 Q Are you familiar with the Schedule I drug
22 ibogaine?
1 A Yes.
2 Q Do you know if that's available from other
3 sources?
4 A I don't know.
5 Q The PHS review process that you talked to
6 us about, that's required only for research
7 proposals requesting marijuana; is that correct?
8 A That's right.
9 Q So not any of the other Schedule I drugs?
10 A Correct.
11 Q I'm sorry. That are made available
12 through NIDA's Drug Supply Program?
13 A Yes.
14 Q Isn't it true, Dr. Gust, that companies
15 involved I pharmaceutical development with
16 privately funded research generally don't go
17 through a NIH peer review process?
18 MS. PAREDES: Objection, foundation.
19 JUDGE BITTNER: Would you rephrase the
20 question because I wasn't quite clear on what it
21 meant?
22 MR. HOPPER: Sure. Let me try that again.
3 Q You testified that there is a NIH peer
4 review process that takes place for research that's
5 done with NIDA provided marijuana; is that correct?
6 A For research on medical applications, yes.
7 Q Right. And--
8 JUDGE BITTNER: In other words, for
9 applicants who are applying to NIDA to receive the
10 drug or for NIDA funding? I think that's where I
11 got a little confused.
12 MR. HOPPER: Well, I can break it down.
14 MR. HOPPER: Because I want to ask about
15 both.
17 Q So for someone who has received or wants
18 to receive NIH funding for research with marijuana,
19 you testified that they would go through an NIH
20 peer review process that is part of their receiving
21 funding.
22 A Right.
1 Q And for researchers who are private
2 funded, who do not apply for NIH funding, you
3 testified that the peer review process is by the
4 Public Health Service Committee that was through
5 the procedures set up in the 1999 announcement?
6 A For applications looking at medical
7 applications, for--or if it's not looking at a
8 medical application, it can go through an ad hoc
9 review that NIDA conducts. So there are three
10 flavors of peer review. One is the NIH peer review
11 system. The second is the PHS Committee peer
12 review. And the third is an ad hoc review provided
13 through NIDA.
14 Q And my question to you then is, isn't
15 there a fourth flavor of peer review that occurs
16 that's completely outside of NIH, that occurs
17 through the FDA's procedures when a researcher is
18 privately funded and is working to do
19 pharmaceutical development?
20 A We only provide the peer review for
21 requests for materials that are provided by the
22 government. So if somebody has materials that are
1 provided not by the government, NIH or NIDA, PHS
2 wouldn't get involved.
3 Q And to your knowledge, does that type of
4 peer review that's outside of NIH's involvement
5 because the researcher is not requesting NIDA
6 materials, does--
7 JUDGE BITTNER: i.e., drugs.
8 MR. HOPPER: i.e., drugs.
11 Q Doesn't that occur fairly regularly?
12 A You're asking about peer review? I have
13 no idea what a pharmaceutical company does in
14 regards to peer review. Certainly NIH--I mean a
15 pharmaceutical company has materials and drugs that
16 they want to test. So one might assume that they
17 have some kind of review process, but I don't know
18 that for a fact.
19 Q And the FDA reviews those protocols,
20 correct?
21 A That's right.
22 Q And the FDA reviews those protocols, and
1 that's completely outside of the NIH peer review
2 process?
3 A Yes.
4 Q So if a researcher's not getting drugs
5 from NIDA--I'm sorry, you went through--you gave us
6 four steps--excuse me one moment.
7 [Pause.]
9 Q You testified that the process by which
10 NIDA distributes marijuana involves four steps.
11 No. 1, peer review for scientific merit. No. 2,
12 registration with DEA. No. 3, an IND is filed with
13 FDA. And No. 4, the researcher would then send in
14 an order form to NIDA. Is that correct?
15 A Yes.
16 Q So researchers that we were just talking
17 about a moment ago that are not trying to get their
18 drugs from NIDA, whose research protocols are
19 reviewed by the FDA, they only need registration
20 with the DEA; is that correct?
21 A Yes.
22 Q And their IND filed with FDA?
1 A Yes.
2 JUDGE BITTNER: Dr. Gust, the order that
3 goes to NIDA, is that the DEA order form?
4 THE WITNESS: Yes, it is.
8 Q So those researchers then don't really
9 need the benefits of the NIH peer review process
10 because the FDA is evaluating their research; isn't
11 that correct?
12 MS. PAREDES: Objection, foundation.
13 JUDGE BITTNER: Grounds?
14 MS. PAREDES: Foundation.
15 JUDGE BITTNER: If you know.
16 THE WITNESS: Could you ask me that
17 question again?
19 Q So those researchers that we were just
20 talking about, don't need the benefits of the NIH
21 peer review process because the FDA is evaluating
22 their protocols; isn't that correct?
1 A No, it's not correct.
2 Q So those researchers that we just talked
3 about do need the benefits of NIH peer review?
4 A That's sort of apples and oranges I think.
5 The FDA process, as I understand it, reviews for,
6 primarily for safety uses, not necessarily for
7 scientific merit. So there would be no requirement
8 certainly for somebody, a pharmaceutical company or
9 company to submit to NIH for peer review, whether
10 it would be a benefit or not.
11 Q Sir, give me one moment, please. So
12 whether or not you would agree with my phraseology,
13 characterization of that as a benefit, those
14 researchers that we were just talking about, as a
15 routine matter, whose protocols were reviewed by
16 the FDA, don't go through the NIH peer review
17 process; is that correct?
18 A Yeah. As I said, only proposals that are
19 requesting material provided by the government
20 would need to go through the NIH--or funding--would
21 need to go through the NIH, PHS or ad hoc review
22 process.
1 Q Is there any time limit on the PHS review
2 process?
3 A I don't understand your question.
4 Q I'm sorry. I'll rephrase that. Are there
5 any requirements in the announcement or elsewhere
6 that impose upon--
7 A No.
8 Q --PHS Review Committee some time limit in
9 which they must complete their review of protocol
10 that's submitted to them by a researcher who's
11 attempting to get marijuana from NIDA?
12 A No.
13 Q No time limit at all?
14 A Not to my knowledge.
15 Q Do you know generally how long that review
16 takes?
17 A I'd say three to six months.
18 Q Are you familiar with the application that
19 was filed by Chemic Labs?
20 MS. PAREDES: Objection, outside the
21 scope.
22 JUDGE BITTNER: I don't know yet.
1 Overruled.
4 Q Do you know--can you tell us why it took
5 two years for the PHS review process to be
6 completed with that application, resulting in the
7 denial of the marijuana?
8 MS. PAREDES: Objection, relevance.
9 JUDGE BITTNER: Overruled.
12 Q When did you first become aware that Dr.
13 Craker had applied to the DEA to be registered as a
14 bolt manufacturer or marijuana?
15 A I can't remember exactly the dates, but it
16 was sometime, I believe, in 2003.
17 Q Do you know that Dr. Craker actually filed
18 his application in 2001?
19 A That's probably correct.
20 Q Can you just briefly outline for us the
21 full extent of your involvement relating to his
22 application prior to your testimony today?
1 A I had no direct involvement in his
2 application. Is that what you're asking me, what
3 involvement I had in his application to DEA?
4 Q What was your involvement with his
5 application, the response to his application?
6 A The response to his application?
7 JUDGE BITTNER: From whom?
9 Q From--I guess what I would like to know is
10 what did you do that was in relationship to Dr.
11 Craker's application that was filed with the DEA
12 for registration?
13 A Oh, I commented on Dr. El Sohly's
14 response to the application.
15 Q You also testified, I think, that you had
16 some discussions with DEA about Dr. Craker's
17 application?
18 A Yeah. I think I was notified that he had
19 filed something with DEA about this.
20 Q Do you remember who notified you?
21 A No. I think it may have--Mr. Sapienza
22 (ph), I think, at the time.
1 Q Do you remember whether that notification
2 was by way of a phone call?
3 A It was a phone call.
4 Q Did you receive anything from writing, in
5 writing from the DEA about the application?
6 A Not that I recall.
7 Q Do you remember if there were more than
8 one phone conversations with DEA about the
9 application?
10 A There may have been more than one, but
11 not--you know, one or two.
12 Q Do you recall a meeting in January of 2004
13 with, among others, representatives from DEA about
14 Dr. Craker's application?
15 A Yes.
16 Q Can you tell us about that meeting?
17 A Well, I have very, very--I'm sorry, but I
18 have very little recollection of that meeting other
19 than it occurred. Do you have something that could
20 prompt my memory?
21 Q Can you tell us who else was there?
22 A No, I can't.
1 Q So if I suggested to you that Helen
2 Kaupang from DEA was there, would that refresh your
3 memory?
4 A No.
5 Q Matt Strait from DEA?
6 A I may remember him being there.
7 Q Tim Condon?
8 A Yes.
9 Q So does that help you remember anything
10 more about--
11 A About the substance of the meeting?
12 Q Just generally?
13 A Yeah, just--quite honestly, I think it was
14 just basically providing us some information on the
15 status of the application that had occurred and the
16 status at that time, information. It was
17 informational.
18 Q Have you ever before been called to a
19 meeting to discuss the application filed by some
20 person to become a bulk manufacturer of a
21 controlled substance?
22 A No, not to my recollection.
1 Q So would you characterize that as an
2 unusual meeting?
3 A Perhaps, but generally we have meetings
4 with DEA on a variety of topics. We share
5 information on topics of mutual interest
6 frequently, and so this was just another one of
7 those topics. So it wasn't extraordinary in that
8 respect.
9 Q I'm sorry. But it was specific to--this
10 meeting was specific to Dr. Craker's application?
11 A You know, I don't even recall that now
12 that you bring it up. There may have been several
13 other items on the agenda. I'd have to go back and
14 see if I even had notes from then. It's very
15 possible and likely actually that there were other
16 issues on the agenda.
17 Q And then at some point you became aware
18 then, probably before this meeting, that Dr.
19 Craker's application and notice of Dr. Craker's
20 application had been published in the Federal
21 Register?
22 A Yes.
1 Q And you became aware that Dr. El Sohly was
2 sending in comments to the Federal Register?
3 A Yes.
4 Q Did you discuss with anyone at DEA whether
5 or not Dr. El Sohly would submit comments
6 responding to Dr. Craker's application?
7 A I don't recall that at all.
8 Q Are you familiar with the requirements
9 under the Statute 21 USC 823 as they pertain to Dr.
10 Craker's application to be registered as a
11 manufacturer?
12 A No, I'm not familiar.
13 Q So prior to reviewing Dr. Craker's
14 application, you didn't have any sort of expertise
15 in the application of that criteria to an
16 application to be registered as a manufacturer?
17 MS. PAREDES: Objection, assumes facts not
18 in evidence. This witness never testified that he
19 reviewed Dr. Craker's application.
20 JUDGE BITTNER: Sustained.
22 Q Did NIDA officially oppose Dr. Craker's
1 application?
2 A No.
3 Q Were you opposed to Dr. Craker's
4 application?
5 A Not at all.
6 Q So did you consider sending a response
7 yourself to the Federal Register from NIDA or from
8 yourself, independent of Dr. El Sohly's letter?
9 A As I recall, it was discussed within NIDA
10 and it was decided that there would be no response
11 from NIDA?
12 Q And you've said that NIDA didn't oppose
13 and you didn't oppose the application. But would
14 you characterize Dr. El Sohly's comments as being
15 in opposition to the application, in opposition to
16 the granting of the application I should say?
17 A Yes.
18 Q I'm sorry?
19 A Yes.
20 Q I'm just trying to understand. If NIDA's
21 not opposed, you're not opposed. Dr. El Sohly
22 clearly is, and you're assisting him with his
1 opposition, did you--
2 A I wouldn't say I was assisting him. As I
3 recall the series of events, he approached NIDA
4 with his intent to respond, and NIDA said, "Fine."
5 And he did share copies of drafts of his response
6 with NIDA, and I do recall looking at those, but
7 for factual--primarily at least for factual
8 accuracy. And so he did solicit a review for that
9 reason, and we provided it.
10 JUDGE BITTNER: When you say NIDA, who in
11 NIDA would make these decisions?
12 THE WITNESS: About--in terms of reviewing
13 the staff response?
14 JUDGE BITTNER: In terms of reviewing Dr.
15 El Sohly's response, and also in terms of deciding
16 whether or not NIDA would file comments. Who
17 actually makes those decisions?
18 THE WITNESS: Either the director or the
19 deputy director, penultimately made that decision.
21 Q Thank you. The process that you've just
22 described of Dr. El Sohly asking for input or
1 assistance,and I'll turn to that in a moment. But
2 was this the first time that you have engaged in
3 that sort of a process with someone responding to
4 an application to be permitted to become a bulk
5 manufacturer?
6 A Yes.
7 Q And are you aware of any prior occasion in
8 which NIDA has played that sort of a role in
9 working with someone opposing an application to
10 manufacture?
11 A There have certainly been other occasions
12 when a NIDA contractor has responded to--has
13 responded in various circumstances, where the
14 contractor would certainly have--you know, work
15 with NIDA staff, whether it's working with them or
16 having products reviewed prior to their submission,
17 not in this specific case, but there are other
18 instances, yes.
19 MR. HOPPER: Can Dr. Gust please be
20 provided with a copy of Respondent's Exhibit 5?
21 [Pause.]
1 Q Do you have that, Dr. Gust?
2 A Yes.
3 Q Can you just please take a look at that
4 document and tell me if you recognize it?
5 A Yes.
6 Q Is this a printed version of an e-mail
7 that you received from Dr. El Sohly on August 29,
8 2003 with his draft comments on the DEA published
9 version of Dr. Craker's application?
10 A Yes.
11 Q And that has attached to it the draft
12 comments from Dr. El Sohly?
13 A Yes.
14 Q Did you discuss the application with Dr.
15 El Sohly prior to receiving this e-mail, do you
16 know?
17 A I believe he informed me of his intent to
18 respond.
19 Q Do you recall if it was your suggestion or
20 Dr. El Sohly's suggestion that he send you a draft
21 so that you could review it?
22 A It was his suggestion, as I recall.
1 Q Looking at that e-mail, he wanting your
2 view in particular, do you see the sentence where
3 he's referring to being aware that there might be
4 information that NIDA wouldn't want him to share?
5 It's in that second paragraph.
6 A Yes, I see that.
7 Q "I understand, Dr. Gust and Dr. Singh,
8 that I might have information there that NIDA would
9 not want me to include, and I'll certainly remove
10 it if that's the case." You see that?
11 A Yes.
12 Q Do you have any ideas about what
13 information he might be referring to there that
14 NIDA would be concerned about, from your
15 conversations with him?
16 A No.
17 Q Can you tell us what was your general
18 reaction to Dr. El Sohly's first draft there?
19 A I thought there were a few factual errors
20 that needed to be corrected. In general though, I
21 didn't have any problem with it.
22 MR. HOPPER: Can we, please, now provide
1 Dr. Gust with a copy of Respondent's Exhibit 6?
2 [Pause.]
4 Q Do you have that, Dr. Gust?
5 A Yes.
6 Q Can you please take a look at that
7 document and tell me if you recognize it?
8 A Yes.
9 Q Do you recall receiving the second draft
10 of Dr. El Sohly's comment regarding Dr. Craker's
11 application?
12 A Yes.
13 Q And does this appear to be a printed
14 version of the e-mail that he sent you in that
15 regard?
16 A Yes.
17 Q And the draft that's attached there. It
18 says Draft No. 2?
19 A Yes.
20 Q And you made corrections to that draft, is
21 that right?
22 A I may have.
1 Q Do you recall making corrections to a
2 draft that he had sent you and then e-mailing them
3 back to him?
4 A I remember making some comments in an e-mail. I
5 don't actually recall making changes to
6 the letter itself.
7 MR. HOPPER: Sorry to make you keep
8 getting up, Nicole. Can you please provide Dr.
9 Gust with a copy of Respondent's Exhibit 7?
10 [Pause.]
12 Q Do you have that, Dr. Gust?
13 A Yes.
14 Q Can you please take a look at that
15 document and tell me if you recognize it.
16 A Yes.
17 Q So does this appear to be a printed
18 version of the e-mail from you back to Dr. El
19 Sohly?
20 A Yes.
21 Q And you see attached to it there is that
22 draft. It says Draft No. 2 still?
1 A Yes.
2 Q And you see down beginning in that last
3 paragraph on that first page, there are some
4 strikeouts and additions of text underlined?
5 A Right.
6 Q Did you make those edits?
7 A This is the part I remember changing,
8 because, yes, the language that he had originally
9 was incorrect, so I made some changes to make it
10 consistent with the policies at the time in that
11 paragraph, and then in the next page, the same
12 changes.
13 Q Excuse me. I'll go through some of these
14 with you. I just want to first though have you
15 look, just glance at the second and third page, and
16 you should see that there's strikeout text and then
17 text that's been underlined. So is it your
18 recollection now that those reflect your changes or
19 your suggested changes to Dr. El Sohly's draft?
20 A Yeah, just let me read them, and then I'll
21 get back to you.
22 Q Sure.
1 [Pause.]
3 Q And just so there's no confusion, Dr.
4 Gust, on that third page there are some handwritten
5 comments. At this point I'm just asking about the
6 stuff that's been--it looks like using a word
7 processing program probably. Text has been
8 stricken and other text added with underlines, and
9 I just want to know if you made those changes, and
10 those are the changes that are referred to in your
11 e-mail back to Dr. El Sohly when you say that, "I
12 have made a few suggested changes. Please take a
13 look."
14 A I don't recall--I recall making the
15 substantive changes in that last paragraph on the
16 first page, and the continuation of the strikeouts
17 and the underlining in that paragraph.
18 The second page, the bottom of page 2, I
19 don't recall making that suggestion strikeout
20 actually. I did suggest that he put a comment in
21 here about the complaints, so that sentence,
22 something I would have suggested. The next
1 paragraph which is stricken, I have no recollection
2 of making that suggestion to him.
3 Q I'm sorry. The one you're referring to
4 now that you're saying you have no recollection
5 making that--
6 A In addition to--the one that starts, "In
7 addition to the above described NIDA program."
8 Q Right.
9 A So I guess what I don't know is if this--I
10 don't think this is the actual marked up draft of
11 my changes. It looks like somebody may have
12 combined some changes from several people, or some
13 recommendations, and put them in this draft.
14 Q Well, let's just go through these one at a
15 time then and see which ones you recall having made
16 and what you can tell us about them.
17 A Okay.
18 Q On the first page, that last paragraph on
19 the page, second line, "Registration with the DEA,"
20 and then it looks like new text "and FDA" has been
21 added. Was that a change that you suggested?
22 A Yes, or I would have, yes.
1 Q And can you tell us why you would have
2 added the FDA?
3 A Well, as previously described, there's
4 really three things that need to happen before NIDA
5 can make marijuana available. That include the DEA
6 registration and the FDA IND application, and peer
7 review. So Dr. El Sohly's draft letter did not
8 include the requirement for the FDA, so that was
9 added.
10 Q Okay. And then the next sentence looks
11 like the sentence has been stricken, "Those
12 researchers are required to provide proposals and
13 protocols for their studies to NIDA for review."
14 Do you know why you would have suggested to strike
15 that sentence?
16 A Because the proposals and protocols are
17 sometimes provided to NIDA, but sometimes not.
18 Sometimes they're provided--it would be to the PHS
19 Committee by this time.
20 Q Okay. In that next sentence, "Those
21 researchers with projects approved," and then "and
22 funded" has been added, and then by--and then it's
1 been added, "NIH including NIDA, receive marijuana
2 at no cost to them and their institutions." You
3 suggested those changes?
4 A Yes.
5 Q And the reason being?
6 A To make it more accurate. I guess the
7 previous--previously it must have read, "Those
8 researchers with projects approved by NIDA receive
9 marijuana at no cost to them or their
10 institutions." That was just not correct.
11 Q Right. This again is reflecting what you
12 told us earlier about sort of the two categories of
13 research projects that might be seeking marijuana
14 from NIDA, one being NIH funded and the others
15 being privately funded.
16 A Right.
17 Q And then it looks like the following
18 sentence, "Those researchers with projects," and
19 then "do not meet," well, that sentence has been
20 changed. It looks like it used to read: "Those
21 researchers with projects"--yeah, did you make that
22 change? I guess I'm not going to try to struggle
1 to figure out what it said before.
2 A Yes.
3 Q Can you tell us what you were seeking to
4 correct or change with that language?
5 A That simply is stating that--as you just
6 stated--there are two types--for the researchers
7 that weren't requesting NIH funding but got
8 approved, then they would receive marijuana, but
9 they would have to pay for it.
10 Q So that paragraph now as it reads with
11 your suggested changes, it doesn't say so, but by
12 scientific approval there in that sentence we were
13 just talking about, that was added?
14 A Uh-huh.
15 Q By "scientific approval" you were
16 specifically referring to PHS review, right, and
17 not the FDA or DEA review that is referred to in
18 that first sentence?
19 A Either PHS review approval or ad hoc
20 consultant review if it was not a medical marijuana
21 project.
22 Q Right, okay. So although it's not really
1 acknowledged clearly in that paragraph as changed,
2 there could be FDA and DEA approved studies that
3 would not necessarily receive marijuana even if
4 they were willing to pay for it, because they
5 didn't get PHS review, right?
6 A That's right.
7 Q And then turning to the second page, there
8 is, again, "NIH or NIDA" is added there. That's
9 your correction?
10 A Yes.
11 Q And I think we understand that from what
12 you've told us before, that there could be NIH
13 approval through the peer review process that
14 happens when someone applies for funding.
15 A Right.
16 Q And then you--the next stricken text is
17 "not approved by NIDA," and that's been replaced
18 with "funded by other sources?"
19 A Yes.
20 Q That's your change?
21 A Yes.
22 Q So doesn't that, with your change, kind of
1 suggest that all research that was--been approved
2 by the government and funded by other sources,
3 would be provided with marijuana from NIDA?
4 A What's approved by the government?
5 Q Yeah. I'm just trying to--right. It
6 says, "These cigarettes are provided to researchers
7 at no charge if their project is approved by NIH or
8 NIDA, or at cost if the project is," and then
9 "approved" is taken out and it just says, "funded
10 by other sources." But isn't it true that there
11 could be projects funded by other sources that
12 aren't going to be supplied with marijuana?
13 A Yeah. I would say the availability of
14 funding for the project was not a requirement for
15 obtaining or receiving peer review. The thing here
16 is that any government provided resource--in this
17 case, marijuana, needed to have a review for
18 scientific merit, and maybe that's part of the
19 issue here, is that any--the issue here is that for
20 government funded research or for government
21 provided resources, there needed to be a judgment
22 whether or not the project was scientifically
1 meritorious, and absent that, government resources
2 could not be use, or the government marijuana could
3 not be provided.
4 Q All right. But just to be clear though,
5 this sentence again is suggesting--it says that,
6 "These cigarettes are provided to researchers at no
7 charge if the project's approved or at cost." So
8 it's suggesting that if someone is funded by other
9 sources and it's not a project that's been approved
10 by NIDA or NIH, that they would be provided
11 marijuana at cost, when in fact, some of those
12 people aren't going to get marijuana at all; isn't
13 that true?
14 A Yes. Yes, if they don't have the
15 scientific review, they're not approved.
16 Q So now just moving to the bottom of that
17 page, is this one of the changes that you said you
18 don't think was your own?
19 A I don't recall making that suggestion. I
20 would have no comment on the factual accuracy of
21 that, so I would have--I wouldn't have a comment on
22 that.
1 Q Okay. And the last sentence in that
2 paragraph, you said that it is a sentence that you
3 could imagine?
4 A Yes.
5 Q Did you recall suggesting that that--
6 A I do recall suggesting that he add a
7 sentence I here about the actual experience that he
8 had in terms of receiving complaints about the
9 marijuana quality.
10 JUDGE BITTNER: So we're looking at the
11 added sentence in the first paragraph on page 2?
12 THE WITNESS: Right.
13 JUDGE BITTNER: I just want to--it occurs
14 to me we've kind of been talking about this. Are
15 we all agreed that in these drafts the words that
16 are struck through are deleted using some kind of
17 revision tool, and the underlining is material
18 that's added? Are you all willing to stipulate to
19 that?
20 MR. HOPPER: That's been my understanding,
21 and I thought I had gotten Dr. Gust's agreement
22 that that looked like what had happened.
1 JUDGE BITTNER: But we don't have a
2 stipulation that that is indeed what happened, as
3 opposed to somebody just merrily running around
4 striking through things and underlining things.
5 MR. HOPPER: That's true, Your Honor,
6 although we do have the final submitted version
7 which tracks that understanding of what the--
8 JUDGE BITTNER: Ms. Paredes, are you
9 willing to stipulate that in these drafts what was
10 stricken through was intended to show proposed
11 deletions, and what was underlined was intended to
12 show proposed insertions?
13 MS. PAREDES: Yes, Your Honor, and I
14 believe that's consistent with Dr.Gust's testimony.
15 JUDGE BITTNER: Okay, thank you.
16 MR. HOPPER: Right, and with Dr. El
17 Sohly's testimony.
18 JUDGE BITTNER: It just occurred to me
19 that we should get that nailed down.
20 MR. HOPPER: Thank you. One moment.
22 Q Turning then to that next paragraph that's
1 completely stricken.
2 JUDGE BITTNER: On page 3?
4 Q On page 3. It begins, "In addition to the
5 above-described NIDA program." Do you see that
6 paragraph, Dr. Gust?
7 A Yes.
8 Q I believe you said that that's not a
9 change that you recommended.
10 A I don't recall making any suggestion on
11 that wording.
12 Q Have you read that paragraph?
13 A Yes.
14 Q Do you--is it factually accurate?
15 A I don't know.
16 Q So what the paragraph is suggesting--I'll
17 paraphrase and please tell me if you disagree. Is
18 that Dr. El Sohly, with a registration, a DEA
19 registration outside of his NIDA contact, is
20 cultivating marijuana legally, and that he could
21 provide some of that marijuana to researchers
22 outside of NIDA's program outside of the NIDA peer
1 review process. Would you agree that that's a
2 correct reading of that paragraph?
3 MS. PAREDES: Objection.
5 MS. PAREDES: Asked and answered.
6 MR. HOPPER: I'm sorry. I didn't hear the
7 objection.
8 JUDGE BITTNER: Asked and answered. The
9 witness said he didn't know if it was accurate or
10 not.
11 MR. HOPPER: I'm not asking about--I'm
12 sorry. He read the paragraph and said he didn't
13 know if the paragraph itself was accurate, and I'm
14 trying to elicit from Dr. Gust what he believes
15 that paragraph says, what it describes.
16 JUDGE BITTNER: Okay. Why don't you ask
17 him that?
19 Q So isn't it true that what this paragraph
20 describes is that Dr. El Sohly, growing marijuana
21 with his license, registration to do so that's
22 separate from his NIDA contract, could provide some
1 of that marijuana to medical marijuana researchers
2 outside of the NIDA program without NIDA peer
3 review?
4 MS. PAREDES: Objection, calls for
5 speculation, and the document speaks for itself.
6 JUDGE BITTNER: Overruled.
7 THE WITNESS: I can only reiterate what--well, I
8 think you just basically paraphrased this
9 sentence, "Materials could be made available to
10 researchers outside the NIDA program if they are
11 properly registered with the DEA, and for some
12 reason do not wish to receive or are not qualified
13 to receive materials under the NIDA program." I
14 have no way of knowing if that's true or not.
15 JUDGE BITTNER: Do you interpret that
16 sentence to say just what it says, I guess?
17 THE WITNESS: Yeah. I mean--
18 JUDGE BITTNER: Well, every once in a
19 while, what is said and what is meant aren't
20 necessarily the same, and only people knowledgeable
21 in the field would know that.
22 THE WITNESS: Oh, yes.
2 Q Are you aware, Dr. Gust, that Dr. El Sohly
3 has a DEA registration that permits him to
4 cultivate marijuana at the University of
5 Mississippi outside of the parameters of the NIDA
6 contract?
7 A Yes.
8 Q And is it your testimony that you do not
9 know whether that marijuana could be provided,
10 legally provided by Dr. El Sohly to medical
11 marijuana researchers?
12 A That is my testimony.
13 Q Just--I know that you've said that you
14 didn't--you don't recall having made these changes.
15 Would it surprise you or refresh your recollection
16 if I told you that Dr. El Sohly testified that in
17 his recollection it was you who explained to him
18 that in fact what that paragraph states is not
19 true, is not accurate, and would not be provided,
20 or would not be legal?
21 A I would have a very different recollection
22 of that, because I definitely would not feel
1 qualified to comment on whether or not that was
2 true or possible or feasible.
3 Q Okay, thank you. So just one last
4 question then on this subject. So NIDA doesn't--you said,
5 you testified that you are aware that Dr.
6 El Sohly has a separate DEA registration that
7 permits him to cultivate marijuana at the
8 University of Mississippi outside the parameters of
9 the NIDA contract; is that correct?
10 A Yes.
11 Q And it's your testimony them that NIDA
12 does not supervise or control in any way Dr. El
13 Sohly's activities in that regard?
14 A Correct.
15 Q You don't--NIDA doesn't supervise them,
16 oversee them, license them?
17 A No.
18 Q Are you aware that Dr. El Sohly has in the
19 past conducted non-clinical analytical research
20 with the marijuana he grows under that second
21 registration?
22 A I'm sorry. Could you ask that again? I'm
1 sorry.
2 Q Sure. Are you aware that Dr. El Sohly has
3 in the past conducted nonclinical, analytical
4 research using the marijuana that he grows outside
5 of his NIDA contract?
6 A I have no knowledge of what he does with
7 the marijuana he grows on that separate contract.
8 Q So I'm assuming then that that--well,
9 maybe I shouldn't assume. I should back up. Would
10 it be your testimony then that any of that research
11 that he's doing is not subject to NIDA supervision?
12 A If he were doing some of it under an NIH
13 grant or with NIH funding, he would, but absent
14 that, no.
15 Q So absent NIH grant or funding, that
16 research wouldn't be subject to NIDA supervision,
17 wouldn't be subjected to the PHS review that we've
18 been talking about; is that correct?
19 A Correct.
20 Q Are you aware of any other authorized
21 privately funded research with marijuana that is
22 able to avoid that PHS review process other than
1 Dr. El Sohly's own research?
2 A Yes. You mean on medical marijuana?
3 Again, we always have the preclinical work that--there is
4 some of that going on.
5 Q I'm sorry. Just to clarify, the
6 preclinical work that you're referring to is
7 reviewed by this other ad hoc process that we
8 referred to, so it's not the PHS review process; is
9 that correct?
10 A Right, right.
11 Q So, yeah, excluding that.
12 A So ask me your question again. Sorry.
13 Q Sure. Are you aware of other authorized,
14 privately funded research with marijuana that is
15 not subject to either the PHS review or this other
16 ad hoc NIH review that you've talked to us about?
17 A No, not in the U.S.
18 MR. HOPPER: Can Dr. Gust please be
19 provided with a copy of Government's Exhibit 24?
20 [Pause.]
21 JUDGE BITTNER: Could I just ask, Mr.
22 Hopper, when you refer to privately funded, do you
1 mean not federally government funded? I'm just
2 thinking--
3 MR. HOPPER: I apologize, Your Honor. I
4 understand your confusion. When I refer to
5 privately funded--and I should have made this
6 clear--I'm using that as a shorthand for non-Federal
7 Government funded, non-NIH, I should say,
8 funded research.
9 JUDGE BITTNER: And that's what you meant
10 too, doctor?
12 JUDGE BITTNER: I just want to be sure you
13 were both in the same page here. Could there be,
14 for example, research that is funded by some other
15 agency of the Federal Government other than NIH or
16 HHS, that, say, goes through an academic
17 institution or also research that's funded by a
18 state government, right?
19 THE WITNESS: Uh-huh.
20 JUDGE BITTNER: So what we're really
21 talking about, when you say "private" you mean non-NIH.
22 THE WITNESS: Right.
2 MR. HOPPER: Right. For instance, there
3 was the CMCR research that was--
4 JUDGE BITTNER: State funded.
5 MR. HOPPER: State funded, but not NIH
6 funded.
7 THE WITNESS: Correct.
8 MR. HOPPER: Thank Your Honor. I should
9 have been more clear with that.
11 Q Do you have Government's Exhibit 24 in
12 front of you, Dr. Gust?
13 A Yes.
14 Q And do you recognize that document?
15 A Yes.
16 Q So that's the one that you were talking
17 about in your direct testimony as setting out the
18 guidelines for PHS review for marijuana research?
19 A Right.
20 Q So for the record, I'm just going to refer
21 to this document during these questions as the 1999
1 NIH announcement.
2 Dr. Gust, do you know, are there
3 additional regulations or guidelines beyond this
4 1999 NIH announcement that governed the provision
5 of marijuana to privately funded, as we now
6 understand that term to be defined, privately
7 funded researchers?
8 A Just the FDA's IND process and the DEA
9 registration process.
10 Q And the ad hoc review process that you've
11 talked to us about, are there separate guidelines
12 or criteria for that process that exist somewhere?
13 A They're generally the same as the NIH peer
14 review criteria that we talked about earlier in
15 terms of looking at the scientific significance and
16 the approach and the--you know, the quality of the
17 investigators and the environment, they're the
18 same.
19 Q So it's they mirror or are closely related
20 to the guidelines that NIH uses when determining
21 whether or not to approve a research grant?
22 A Yes.
1 Q And the guidelines in this 1999 NIH
2 announcement set out the criteria that's used by
3 the PHS review committee that you referred to in
4 your direct testimony, to determine whether or not
5 NIDA will marijuana to a privately funded
6 researcher, isn't that right?
7 A Yes.
8 Q And just to clarify another point of
9 terminology here, we've been referring to PHS
10 review and a PHS Committee. Can you just
11 distinguish for me what--I know that PHS refers to
12 Public Health Service, which I assume has a great
13 many other responsibilities than just reviewing
14 research protocols for marijuana, is that right?
15 A Yes.
16 Q So the PHS review that's being referred
17 to, that is review that is conducted by a committee
18 of the Public Health Service, is that correct?
19 A Yes. Members are from the Public Health
20 Service and its components, NIH, FDA.
21 JUDGE BITTNER: You just lost me. The
22 Public Health Service--so the people who do the
1 peer review, the PHS review, are they employees of
2 the Public Health Service?
3 THE WITNESS: Inasmuch as I'm an employee
4 of the Public Health Service. In other words, the
5 Public Health Service runs the committee, chairs
6 the committee and runs the committee. The members
7 of the committee are from the PHS and its component
8 agencies including FDA, NIH--
9 JUDGE BITTNER: The PHS--oh, I'm really
10 confused. So PHS is the umbrella within the
11 Department of Health and Human Services?
15 JUDGE BITTNER: Oh, okay. Maybe I need an
16 organizational chart of HHS.
17 MR. HOPPER: Yeah, I could also benefit
18 from--
19 MR. BAYLY: Excuse me. I just want to
20 note for the record, we do have an exhibit that's
21 going to cover it. It's a statute that I think
22 just lists the agencies.
1 JUDGE BITTNER: Okay, because I didn't
2 realize that. That's why I was so confused.
3 MR. HOPPER: I'm sorry. Ms. Paredes, has
4 that exhibit already been introduced? Is there a
5 way to--
6 MS. PAREDES: It's not been introduce yet,
7 but it's Government Exhibit--
8 MR. BAYLY: No, it hasn't been introduced
9 yet.
10 JUDGE BITTNER: But could we refer to it?
11 That might help.
12 MR. HOPPER: --that I could refer to as
13 we're--
14 MR. BAYLY: Yes.
15 MR. HOPPER: What's the number that was
16 assigned?
17 MR. BAYLY: I knew you were going to ask
18 that.
19 [Laughter.]
20 JUDGE BITTNER: No pointing, Mr. Hopper.
21 MR. HOPPER: Excuse me. I was scratching
22 you head.
1 JUDGE BITTNER: Yeah, yeah, that's what
2 they all say.
3 MR. HOPPER: Perhaps 34, Government's
4 Exhibit 34?
5 JUDGE BITTNER: Yes, that's what it looks
6 like.
7 MR. BAYLY: Yes.
9 MR. HOPPER: Thank you very much, Mr.
10 Bayly.
11 MR. BAYLY: Can we move to admit this
12 right now then?
13 JUDGE BITTNER: Any objection, Mr. Hopper?
14 MR. HOPPER: No objection.
15 JUDGE BITTNER: Government 34 is received.
16 [Government's Exhibit No. 34
17 received in evidence.]
19 Q So, Dr. Gust, who set up the PHS
20 Committee? Is that the PHS that established the
21 committee, or was it NIH?
22 A PHS.
1 Q And can you just tell me the organizations
2 from which its members, the PHS Review Committee's
3 members are drawn?
4 A FDA, NIH, primarily. I believe other
5 agencies are--have been--I'm trying to remember if
6 they actually were members--but SAMSA, the
7 Substance Abuse and Mental Health Services
8 Administration. I think those three.
9 Q Thank you. So the guidelines that we're
10 looking at Government's Exhibit 24, they--isn't it
11 true that they establish a level of review that is
12 above and beyond FDA approval and DEA approval of
13 the research protocol?
14 A I would say--above and beyond--I would say
15 no, because there's always been a requirement for
16 scientific review, whether it's provided through
17 the NIH peer review system or the NIDA ad hoc
18 system prior to 1999. So this was just adding one
19 more way of achieving that scientific peer review.
20 It's not above and beyond. It's just an
21 alternative method to achieve that.
22 Q But for researchers who have not applied
1 for NIH funding, don't these guidelines set out
2 criteria and a review process that is an additional
3 layer of review beyond just the DEA registration
4 and FDA review of protocol that would be--
5 A Not for anybody looking for government
6 resources, i.e., government provided marijuana.
7 Q Right. That's my--
8 A If it's not government provided marijuana,
9 then it would be, but those are reviewed, as you
10 previously stated. Those go to the FDA and the DEA
11 for other Schedule I drugs, for example, that are
12 available from other sources. So any applicant
13 looking for government resources, i.e., government
14 provided marijuana, has always needed to be
15 subjected to a scientific peer review to determine
16 whether or not it was scientifically meritorious.
17 Q Right. But someone who, a researcher who
18 is not seeking government provided resources, who
19 wants to do research with a controlled substance
20 other than marijuana, would not need to go through
21 this type of a review process, right?
22 A Correct.
1 Q So just to be clear, a privately funded
2 researcher might well obtain the appropriate DEA
3 Schedule I registration, have their protocol
4 reviewed and approved by the FDA, and still be
5 denied access to NIDA marijuana by a PHS Committee
6 under the conditions and priorities that are set
7 forth in this document; isn't that correct?
8 A Yes.
9 Q And PHS, for instance, gives preference to
10 protocols that have specific safety or efficacy
11 endpoints. Is that one of the criteria that they
12 establish here?
13 A That's in the guidance, yes.
14 Q And therefore, protocols for ongoing
15 trials are not likely to be deemed eligible to
16 receive NIDA marijuana, isn't that correct?
17 A Not necessarily. I'm a little confused by
18 the question. How could it be an ongoing trial if
19 they didn't have marijuana, if they're going to use
20 marijuana?
21 Q Sorry. Just give me a moment. I want to
22 refer to a specific part of this document. So
1 turning your attention then to the third page of
2 that document, Dr. Gust, see that heading, Roman
3 numeral IV, Marijuana Trial Design Elements?
4 A Yeah.
5 Q Second paragraph, second sentence.
6 "Protocols for open-ended or ongoing trials that do
7 not include ending dates are not likely to be
8 eligible to receive marijuana."
9 A You're asking what that means?
10 Q Yes. Can you give me an example that
11 illustrates the difference between a specific
12 endpoint and an ongoing trial?
13 A Well, I didn't draft this, but let me see
14 if I can help. I think it's just simply stating
15 that preference would be given to controlled
16 studies that had specific start and endpoints, and
17 in terms of both time and the outcome measures.
18 The next sentence that you read I think is
19 referring to basically what it says. Open-ended
20 trials are trials that have no specific endpoints
21 in terms of time or outcome measures. So basically
22 it just goes back to kind of the scientific rigor
1 and merit of the application, and it's simply
2 stating that priority would be given to those that
3 had more clear-cut goals and endpoints than those
4 who did not.
5 Q Okay. Thank you, Dr. Gust. I'm trying to
6 understand that distinction. I mean are you able
7 to provide an example of a--can you sort of
8 describe for us a hypothetical study that would be
9 uneligible under that criteria?
10 A I cannot.
11 JUDGE BITTNER: Do most studies have
12 endpoints?
13 THE WITNESS: Most do.
14 JUDGE BITTNER: You say we're going to do
15 this for three months or two years or 40 years or
16 whatever.
17 THE WITNESS: Yeah, absolutely.
19 Q Isn't it true that this 1999 NIH
20 announcement evinces a strong PHS preference for
21 clinical research?
22 A It's all about clinical research, isn't
1 it?
2 Q I'm sorry. When you say it's all about,
3 are you referring to--
4 A This whole guidance is about clinical
5 research, that is, studies of the medical
6 applications of marijuana in patients, would all be
7 clinical studies.
8 Q Right. But a study, for instance, that
9 wanted to measure the functionality of a vaporizer
10 device to measure the output of that device when
11 marijuana is vaporized on it, with the intention of
12 eventually being able to use that kind of device in
13 a clinical trial.
14 A Right.
15 Q Would be hard pressed to qualify under
16 these criteria and guidelines; is that true?
17 A Not at all.
18 JUDGE BITTNER: No, it wouldn't be hard
19 pressed to qualify?
20 THE WITNESS: Would not be hard pressed.
22 Q I'm just trying to understand why you say
1 that in light of your previous comment that really
2 this is all about clinical research?
3 A Well, studies of--vaporizer studies, as
4 you described them, would be clinical studies.
5 Looking at--certainly, you know, the delivery of
6 marijuana constituents in a vaporizer to be
7 delivered to human patients would be a clinical
8 study.
9 Q I understand that. I was asking about a
10 study that, a research protocol that proposed to do
11 a study preliminary to clinical studies.
12 A Right.
13 Q That would just be an analytical--
14 A There would be no prejudice against those
15 types of studies based on this guidance, nor has
16 there been in practice.
17 Q Isn't it true that the PHS Review
18 Committee will examine the goals of a proposed
19 research protocol to see if those goals are
20 consistent with those described in this
21 announcement?
22 A In practice the Committee has reviewed
1 projects primarily based on--not primarily--exclusively
2 based on the review criteria, as I
3 previously described.
4 Maybe this would be a good point to just
5 say a little bit more about the review process at
6 NIH and the review process at--in terms of what
7 they do, in terms of making judgments about the
8 scientific merit of a proposal. The NIH committees
9 typically make--first they make an initial cut
10 about whether a project is not recommended for
11 further consideration, i.e., disapproved. That's a
12 certain percentage of the proposals that get not
13 recommended for further consideration and they're
14 disapproved.
15 All the other proposals get reviewed, and
16 basically they get a score, they get a grade. They
17 get a grade from 1 to 5, where 1 is the best and 5
18 is the worst, but 1 through 5 are all approved.
19 And there's basically a priority score, it's
20 called, in terms of Number 1 is the highest
21 priority, Number 5 is the lowest priority. And
22 then all the approved projects can be considered
1 for funding by whatever NIH institute a proposal is
2 assigned to.
3 In practice, of course, there's never
4 enough money to fund all the approved projects, and
5 so what happens is generally projects with
6 priorities between 1 and 2, there's a cutoff
7 between 1 and 2, so only the highest-ranked
8 projects get funded. The PHS Committee uses sort
9 of a similar kind of metric, where there's--projects can be
10 not recommended for further
11 consideration or disapproved, or they can be ranked
12 high priority, low priority, but basically it's a
13 decision of whether it's approved or not approved,
14 and the PHS Committee in practice has basically not
15 discriminated against--has not made a distinction
16 between a Priority 1 versus a Priority 5, in other
17 words, the high priority or low priority.
18 Basically the bar, scientific bar has been set very
19 low, that any project that has scientific merit is
20 approved.
21 And while the criteria that you're
22 mentioning and the guidance in terms of relevance
1 to clinical practice and so forth, may be part of
2 the discussion. They generally would only affect
3 the enthusiasm or that priority score ranking. It
4 wouldn't affect whether or not a project was
5 approved or disapproved.
6 JUDGE BITTNER: To receive NIDA marijuana.
7 THE WITNESS: To receive NIDA marijuana.
8 And anything that gets approved gets NIDA
9 marijuana. So it gets approved for NIDA marijuana
10 with high enthusiasm, medium enthusiasm or low
11 enthusiasm. It doesn't matter, they're all
12 approved to receive NIDA marijuana.
14 Q So is it your testimony then that these
15 guidelines, the written criteria that are referred
16 to here as priorities and conditions, that those
17 are supplemented by or--what's the appropriate
18 word? That there's an informal process that occurs
19 that isn't really reflected by the written
20 document?
21 A Can you--maybe you should tell me exactly
22 where you're looking in here.
1 Q On page 2 of Government's Exhibit 24 at
2 Roman numeral heading II, Availability of Marijuana
3 for Research Purposes. "HHS has determined that it
4 will make research grade marijuana available on a
5 cost reimbursable basis subject to the priorities
6 and conditions described in Section 3 below."
7 Doesn't that suggest that HHS is going to
8 condition, NIDA's going to condition the provision
9 of marijuana to a researcher on the criteria that
10 are laid out there?
11 A Uh-huh.
12 Q And is what you're describing an informal
13 process that is more forgiving than the written
14 text of the document? I'm just trying to be sure I
15 understand your testimony.
16 A Can I have a minute just to read this, so
17 that I'll answer your question better?
18 Q Take as long as you need.
19 [Pause.]
20 THE WITNESS: Okay. Your question was
21 whether Section 3 here is used in to guide the PHS
22 review?
1 MR. HOPPER: Yes.
4 Q All right. Let me just turn then just to
5 some of the specific conditions and priorities that
6 are set out there to see if we can get a better
7 understanding of exactly what kind of research will
8 or will not be provided with marijuana. Do you see
9 that first full--or the second paragraph under that
10 Roman heading II?
11 A Uh-huh.
12 Q Second sentence beginning, "The goal of
13 this program must be to determine whether
14 cannabinoid components of marijuana." Can you just
15 read from that point through the end of that
16 paragraph? Not out loud, but just to yourself.
17 A Okay.
18 Q So isn't it true that according to this
19 announcement, the PHS review process is going to
20 strongly favor and in fact encourage research with
21 other than whole plant marijuana, in other words,
22 the cannabinoids and synthetics, the derivatives,
1 and non-smoked delivery systems?
2 A I think that's the ultimate goal of the
3 program, yes.
4 Q I'm sorry. It's the ultimate goal of?
5 A Of the program.
6 Q Of the program. And isn't it true that
7 when the PHS Review Committee is reviewing a
8 research protocol, that one of the things they look
9 very closely at is whether the goals of the
10 research are consistent with the goals of the
11 program?
12 A Yes.
13 Q So would you agree then that a researcher
14 who was seeking to do research with the intent of
15 taking the whole plant marijuana, smoked or
16 vaporized, through the FDA approval process and
17 through the pharmaceutical development process, to
18 make it available as a prescription drug, would--
19 MS. PAREDES: Objection.
20 MR. HOPPER: I'm sorry.
21 JUDGE BITTNER: You can finish.
22 MR. HOPPER: Would have a very difficult
1 time gaining approval from the PHS Review Committee
2 under the criteria that are delineated here in the
3 announcement?
4 THE WITNESS: Not at all. There's an
5 understanding that research with the crude plant
6 material is a necessary first step in demonstrating
7 proof and principle, if you will, before additional
8 research in purifying pharmaceuticals and
9 components of marijuana, and developing non-smokable and
10 alternative delivery devices could
11 occur. So there is a need for research on smoked
12 marijuana.
14 Q All right. But the--calling your
15 attention to that same paragraph that you just
16 read, the last sentence of that paragraph, "As the
17 IOM report stated, therefore, the purpose of
18 clinical trials of smoked marijuana would not be to
19 develop marijuana as a licensed drug, but such
20 trials could be a first step towards the
21 development of a rapid onset non-smoke cannabinoid
22 delivery system."
1 Now, isn't that pretty clearly stating
2 that researchers with the goal of developing
3 marijuana as a licensed drug would have research
4 with the goal that is inconsistent with this
5 program?
6 A That's a question for FDA. It's not a
7 question for this program or for research on smoked
8 marijuana. And also, this is a comment by IOM,
9 it's not a comment of the PHS. I can clearly say
10 that there is a strong endorsement of this concept
11 within NIH and HHS that ultimately there's going to
12 be pharmaceuticals developed based on the
13 components of marijuana, that there will be
14 purified pharmaceuticals. They won't be in a
15 smoked product, and they'll probably develop to be
16 administered through alternative delivery devices.
17 Q I understand what you said, that
18 ultimately this is a question for the FDA. But
19 isn't it true that under the current system, with
20 NIDA having complete control over the provision of
21 marijuana for research, that there are research
22 protocols approved by the FDA to do research with
1 whole-plant marijuana that are not provided with
2 marijuana under these guidelines? PHS with that
3 additional layer of review says no to research that
4 has been approved by the FDA. Isn't that true?
5 A Well, I have problems with--there is no
6 additional review, and I also take issue with your
7 characterization that NIDA has complete control
8 over the distribution of marijuana. Actually, NIDA
9 has very little control over who gets marijuana for
10 research purposes. It's based upon recommendations
11 of either an NIH peer review committee or the PHS
12 committee, for the most part.
13 Q I believe that you've testified, though,
14 and just to be clear, NIDA's marijuana, which can
15 be obtained only through an application by a
16 researcher to NIDA--
17 A I'm sorry. Go ahead.
18 Q I'm sorry, what--let me back up. I
19 thought you said there were four steps that someone
20 has to go through in order to obtain marijuana
21 through the NIDA program.
22 A Right.
1 Q And that the fourth of those steps was the
2 submission of a form--
3 A Yes.
4 Q --to NIDA.
5 A Right.
6 Q That's the only way that a researcher--privately
7 funded, government funded, anywhere in
8 the United States--can get marijuana to do that
9 research. Isn't that true?
10 A Well, that--you're mischaracterizing the
11 fourth step. There are really three steps, the
12 first three things you mentioned.
13 Q Okay.
14 A There's an FDA IND process, there's a DEA
15 registration, and there's a scientific peer review.
16 The fourth--what you're characterizing as a fourth
17 step is simply a piece of paper, just the
18 paperwork. It's a way to administratively make it
19 happen. There has to be some kind of
20 administrative procedure, and that's the DEA Form
21 222 that's actually sent to the NIDA contractor.
22 So there's no decision at that point. There's no
1 decision that NIDA makes at that point. There's
2 simply an order form.
3 Q Isn't it true that the only way that a
4 researcher in the United States can get marijuana
5 to do research is through this program that
6 provides marijuana that is under the control of,
7 grown under contract with, NIDA?
8 A Yes.
9 Q So unless a researcher is able to get
10 marijuana from NIDA through this program, that
11 researcher cannot do his or her research. Correct?
12 A Yes.
13 Q And this program you've described, I think
14 that we've established, sets up conditions and
15 criteria such that a researcher who has FDA
16 approval for a research protocol and who, if their
17 research were with any other controlled substance
18 than marijuana, could just get the controlled
19 substance and proceed with the research, can't
20 proceed with that research unless they get their
21 marijuana from NIDA. Isn't that right?
22 A Well, there's a few Schedule I substances,
1 as I've said, are available from other sources, but
2 not "any" other Schedule I substance. And then,
3 yes, as I've described, there is a requirement for
4 a scientific review before any government resources
5 can be used--and in this case it's government-produced
6 marijuana can be provided to researchers.
7 So yes.
8 JUDGE BITTNER: Doctor, I have a feeling
9 we're back to being on parallel planes here.
10 Earlier, I think you took issue with something in
11 one of Mr. Hopper's questions referring to NIDA
12 approval, if I recall correctly, a few minutes ago.
13 Does NIDA have representatives that sit on the PHS
14 committee?
16 JUDGE BITTNER: Who makes the decision as
17 to whether the product, the marijuana, will be
18 provided? Who actually says this guy gets it, this
19 guy doesn't?
20 THE WITNESS: It's a committee decision.
21 JUDGE BITTNER: The PHS committee?
1 JUDGE BITTNER: Okay, the director, the
2 deputy director and so on of NIDA do not sign off
3 on that? In other words, the committee is the
4 final authority?
6 JUDGE BITTNER: And the people on the
7 committee are from where?
8 THE WITNESS: They're from NIH, FDA, and I
9 think there's been--I think SAMSA--I mean, SAMSA, I
10 know that three agencies that have been requested
11 to participate in this are the FDA, NIH, and SAMSA.
12 JUDGE BITTNER: Are they employees of
13 those components?
14 THE WITNESS: Yes. They are.
15 JUDGE BITTNER: They're not private
16 practitioners who are called in as--
18 JUDGE BITTNER: --contractors or
19 representatives, like of the American Medical
20 Association or something like that?
22 JUDGE BITTNER: Okay. Go ahead, Mr.
1 Hopper.
2 MR. HOPPER: Thank you, Judge Bittner.
4 Q And just to clarify something you just
5 said, Dr. Gust, did you say that representatives
6 from those other government agencies have been
7 invited to participate on the PHS committee, or
8 actually participate currently? Is there someone
9 from FDA on the PHS Review Committee now?
10 A Yes. I believe so. Actually, I think
11 you'd better not quote me on that. I'm not exactly
12 sure who the members are.
13 JUDGE BITTNER: How big is the committee?
14 And does the committee sit for, like, a period of
15 time?
16 THE WITNESS: It's a group that is, that
17 meets as needed.
18 JUDGE BITTNER: Is it always the same
19 people, or--
21 JUDGE BITTNER: --do they have specific
22 terms, or...?
1 THE WITNESS: It's not--there's no
2 specific term of membership, it's more--people are
3 identified for their specific expertise, for a
4 specific protocol. If somebody has a protocol, for
5 example, to look at marijuana and pain, effects on
6 pain, there will be somebody from the National
7 Institute of Neurology on the committee.
8 JUDGE BITTNER: So it's a--
9 THE WITNESS: With cancer, it's sort of ad
10 hoc according to what the specific protocol is
11 about. But in general, there's from six to 10
12 members.
13 JUDGE BITTNER: Who appoints the members?
15 JUDGE BITTNER: Who in the PHS?
16 THE WITNESS: Pardon?
17 JUDGE BITTNER: Who in the PHS?
18 THE WITNESS: It's--there's an executive
19 chairperson of the committee.
20 JUDGE BITTNER: And that's a continuing
21 function?
1 JUDGE BITTNER: So this individual would
2 say, okay, this particular proposed research has to
3 do with--
4 THE WITNESS: Cancer pain or whatever.
5 JUDGE BITTNER: And therefore we need
6 somebody from--
7 THE WITNESS: Cancer Institute.
9 THE WITNESS: Neurology. Whatever.
10 JUDGE BITTNER: And then does this
11 chairman contact the prospective committee
12 members,or does the chairman call the director of
13 the Cancer Institute?
15 JUDGE BITTNER: Okay. Thank you. Go
16 ahead, Mr. Hopper.
17 MR. HOPPER: Thank you very much, Judge
18 Bittner.
20 Q Do you know--are you familiar with the
21 composition of the--well, let me just back up for a
22 second. I believe that your final answer to my
1 last question was that you couldn't tell us whether
2 or not there's someone from the FDA on the PHS
3 committee?
4 A I know there has been in the past, I just--I can't
5 tell you currently if there is or not.
6 Q Do you know who was on the PHS Review
7 Committee that reviewed the Chemic Labs protocol
8 that was denied?
9 MS. PAREDES: Objection. Relevance.
10 JUDGE BITTNER: Overruled.
11 THE WITNESS: Do you want specific names
12 and members? I could give you a few names of
13 individuals.
15 Q Yes, if you could. I mean--
16 A I know the institutes. I know the
17 institutes that were represented were the National
18 Center on Complementary and Alternative Medicine,
19 the National Cancer Institute, the National
20 Institute of Neurology, NIDA. And one or two
21 others.
22 JUDGE BITTNER: Doctor, what's the
1 difference between a center and an institute? If
2 there is one.
3 THE WITNESS: Prestige. No, centers are--there's
4 no real difference. NIH is comprised of
5 centers and institutes. They're sort of the same.
6 JUDGE BITTNER: I see. Somebody just
7 wanted to confuse the--
8 THE WITNESS: Yeah, right.
11 Q So no one from FDA, to your knowledge?
12 A I--quite honestly, I can't remember if
13 there was somebody from FDA. There may have been.
14 Q What department does the Public Health
15 Service chair for? I'm sorry, I didn't quite get
16 that.
17 A He's in the Office of the Secretary.
18 Q Office of the Secretary of HHS?
19 A Office of the Secretary of Health and
20 Human Services.
21 Q What's his name?
22 A Up to now, it's been Joel Eggertson.
1 Q Mr. Eggertson is retired, is that it?
2 A Mr. Eggertson has recently retired, yes.
3 Q And you don't know who the replacement is?
4 A No.
5 Q So if I--I think that is very useful
6 information and I'm afraid it got me a little bit
7 off my main track. I want to try to get back to
8 that, which is that--and so forgive me if I'm
9 repeating a question. I'm sure that counsel for
10 the DEA will let us know if I am.
11 I'm trying to understand your earlier
12 response that a person who was seeking a researcher
13 or a research sponsor, seeking to do research with
14 marijuana, whole-plant marijuana, smoked marijuana,
15 with the stated goal an intent of that research
16 being to take whole-plant smoked marijuana through
17 the FDA approval process and make it available as a
18 prescription medicine, would be able to do that
19 under the criteria set out in this announcement.
20 Is it your testimony that a person seeking
21 to do that kind of research would not have a
22 problem getting marijuana from NIDA under the
1 criteria laid out in this announcement? On the
2 basis that what they're trying to do is
3 inconsistent with the goals of the program?
4 A If they had an IND from FDA, I would say
5 they would not have a problem getting marijuana.
6 JUDGE BITTNER: And when you say, Mr.
7 Hopper, when you say a whole plant--again, I have a
8 certain naivete about marijuana in general. When
9 you refer to "whole-plant smoked marijuana," are
10 you referring to something akin to a marijuana
11 cigarette?
12 MR. HOPPER: Yes, Judge Bittner, I--
13 JUDGE BITTNER: In other words, a
14 prescription product that looks like a cigarette?
15 MR. HOPPER: Yes, or--
16 JUDGE BITTNER: And that you light and you
17 smoke?
18 MR. HOPPER: --rolled cigarette, but my
19 distinction is between the botanical plant and
20 cannabinoids that have been extracted or
21 synthesized in a lab.
22 JUDGE BITTNER: Okay. All right. That's
1 a little different than what I meant, then.
2 MR. HOPPER: Well, I'm very glad that you
3 asked the question, then, because I think that--
4 JUDGE BITTNER: I guess what I'm asking
5 is, what sort of item is the consumer going to pick
6 up at the drugstore when the prescription is
7 filled? What will that thing look like?
8 MR. HOPPER: My understanding is that in
9 Canada, for instance, what it looks like is either
10 a rolled cigarette or a--what Dr. El Sohly referred
11 to as a "bud." Marijuana in a plastic package, as
12 he was describing that he was--he saw the Dutch
13 manufacturing plant.
14 JUDGE BITTNER: Okay, but it's actually
15 plant material?
16 MR. HOPPER: Right. Right, versus a--I'm
17 sorry.
18 JUDGE BITTNER: Versus a tablet or a
19 capsule that contains something that's made out of
20 plant material, or extracted from it?
21 MR. HOPPER: Precisely.
22 JUDGE BITTNER: Okay, so I guess the
1 question is would someone who's intended goal was
2 to achieve FDA approval for such a product as a
3 prescription drug have more difficulty getting
4 marijuana from NIDA than would somebody who wants
5 to produce some sort of an extract. I don't know,
6 is that the question, Mr. Hopper?
7 MR. HOPPER: Yes.
9 THE WITNESS: I don't believe so.
11 THE WITNESS: I mean, that would be a
12 tough road to hoe--tough row to hoe to get there,
13 for sure. But that's not a question for the
14 research, it's a question for the approval process,
15 the regulation and approval process that goes on
16 through FDA. And I really can't comment on that.
17 JUDGE BITTNER: In other words, that's a
18 question as to whether or not this "stuff"--
20 JUDGE BITTNER: --could ever be safe,
21 effective, et cetera, as a prescription drug?
22 THE WITNESS: Yeah, I don't think there's
1 any presumption that the ultimate goal of any
2 particular researcher looking at a product--or
3 looking at a research proposal, if the ultimate
4 goal is to have that, have the marijuana ultimately
5 approved as medicine or have an extract of
6 marijuana approved as medicine or have some
7 purified component of marijuana approved as a
8 medicine, does not significantly impact whether or
9 not that protocol is approved. In my view.
11 Q But by the FDA or by--
12 A No, by the PHS review--
13 Q By the PHS.
14 A The PHS Review Committee.
15 Q I just--I'm trying to understand. I just
16 want to read the sentence to you.
17 A Okay.
18 Q The goal of this program must be to
19 determine whether cannabinoid components of
20 marijuana administered through an alternative
21 delivery system can meet the standards enumerated
22 under Food, Drug, and Cosmetic Act for commercial
1 marketing of a medical product, as the IOM report
2 stated. Therefore, the purpose of clinical trials
3 of smoked marijuana would not be to develop
4 marijuana as a licensed drug, but such trials could
5 be a first step toward the development of rapid
6 onset non-smoked cannabinoid delivery systems.
7 Isn't it true that that states, in pretty
8 strong terms, that the goal of the research must
9 be--
10 A That's the IOM's view. And I would say--as I
11 said, I think the HHS would strongly endorse
12 that, that ultimately, if there's going to be an
13 approved medication, it's going to be a purified
14 constituent of marijuana that will be delivered in
15 a non-smokable form. You know, and I think that's
16 certainly the strong preference. If you're asking
17 me if there's a bias towards the concept of
18 approving marijuana as a medication, I would say
19 not at the level of the PHS review--in my view, in
20 my experience.
21 Q But what you just referred to as a strong
22 bias, is that not expressed in very clear terms in
1 this document, which sets out the conditions and
2 priorities under which PHS will approve protocols
3 to receive NIDA marijuana?
4 A It doesn't really set--what does it up
5 that--it simply is stating--I don't see how that
6 preempts--that's preempted in any way in terms of
7 what particular studies or what particular goals of
8 any particular study might be. I just don't see
9 that.
10 Q Well, wouldn't you agree that that
11 paragraph that we've just been looking at, where it
12 says "the goal of this program must be," doesn't
13 the "this program" refer to the program--NIDA's
14 provision of marijuana to researchers under the PHS
15 review process?
16 A I think--
17 MS. PAREDES: Objection. Asked and
18 answered.
19 JUDGE BITTNER: Overruled.
20 THE WITNESS: I think that is an ultimate
21 goal but that does not preempt any other studies
22 along the way.
2 Q Okay. And isn't it true that a researcher
3 with FDA approval and DEA approval for their
4 research could still be denied access to NIDA
5 marijuana under the guidelines and conditions that
6 are set out here in the announcement?
7 A If they do not have scientific merit, then
8 it's true.
9 Q Right, if the PHS committee determines
10 that there's no scientific merit.
11 A That's correct.
12 Q And is it your testimony that the FDA,
13 then, by approving a protocol, hasn't evaluated the
14 scientific merit of the protocol?
15 A I don't--
16 Q So just turning your attention to the
17 third page of that announcement, Government's
18 Exhibit 24--do you have that page, Dr. Gust?
19 A Yes.
20 Q Okay. Roman numeral IV, heading
21 "Marijuana Trial Design Elements."
22 A Mm-hm.
1 Q Third paragraph down. Doesn't that
2 sentence read, "FDA's primary objectives in
3 reviewing an IND are in all phases of the
4 investigation to assure the safety and rights of
5 subjects and in Phase 2 & 3 to help assure that the
6 quality of the scientific evaluation of drugs is
7 adequate to permit an evaluation of the drug's
8 effectiveness and safety. Therefore, FDA's review
9 of Phase 1 submissions will focus on assessing the
10 safety of Phase 1 investigations. FDA's review of
11 Phases 2 & 3 submissions will also include an
12 assessment of the scientific quality of the
13 clinical investigations and the likelihood that the
14 investigations will yield data capable of meeting
15 statutory standards for marketing approval."
16 Do you agree with that statement of FDA
17 objectives?
18 A I don't work at FDA, I'm not an expert on
19 FDA, so I can't comment on--I mean, it's written
20 there. As to whether or not it's accurate and
21 would reflect what FDA would say in this chair, I
22 can't answer that. I assume it was vetted and
1 approved by them, but I have no personal knowledge
2 of that.
3 Q Well, just given your experience and the
4 work that you do for NIDA, is it your belief that
5 the FDA would approve a research protocol that had
6 no scientific merit?
7 A Well, I think the FDA generally, as is
8 stated here, reviews protocols for safety concerns.
9 And that's based upon the presumption that a drug
10 company would never put forward a compound to be
11 tested if it wasn't going to provide data that they
12 would be able to use to get ultimate drug approval.
13 And so...
14 Q Okay. What you just described is FDA
15 Phase 1 studies, right? Safety--
16 A That's what it says here, yeah.
17 Q Right. Phase 2 & 3, though, it says the
18 submissions will include an assessment of the
19 scientific quality of the clinical investigations.
20 Doesn't that indicate that the FDA, in its review
21 of research protocol for Phase 2 & 3 studies, is
22 evaluating the scientific merit of the research
1 protocol?
2 A That's what it says, yes.
3 Q Just going back to this distinction that
4 Judge Bittner helped us clarify between what I've
5 been referring to as whole-plant marijuana versus
6 cannabinoids and extracts, isn't it true that an
7 example of a non-smoked cannabinoid delivery system
8 such as that given preference by the conditions and
9 priorities set out in the announcement, an example
10 of such a system would be the THC suppository
11 product that's being developed by Dr. El Sohly?
12 A Yes.
13 Q And isn't the FDA's stated position that
14 FDA is receptive to research into the medicinal
15 uses of botanical marijuana, not just cannabinoids
16 or synthetics?
17 A I don't know that.
18 Q Dr. Gust, if a privately funded researcher
19 wanted to conduct purely analytical and good lab
20 practice research--say, again, the example that I
21 gave you earlier, to measure the functionality of a
22 vaporizer machine designed to deliver cannabinoids
1 from botanical marijuana--with the goal of
2 eventually facilitating FDA approval of botanical
3 marijuana using a vaporizer delivery system, isn't
4 it true that PHS would be unlikely to grant its
5 approval for marijuana--
6 A That's a PHS decision, actually. I mean,
7 anytime there's a--we defer to the PHS anytime I
8 get a request or an application for marijuana when
9 a decision needs to be made about whether or not
10 it's ultimately going to be of clinical relevance
11 and related to medical use of marijuana. So I
12 can't say that necessarily. Certainly there are
13 instances, and I think the proposal you're
14 referring to is one that was deemed to be
15 appropriate for review by the PHS committee, given
16 that it was going to be ultimately used, or the
17 goal was to use it in patients.
18 JUDGE BITTNER: Mr. Hopper, what would be
19 non-botanical marijuana?
20 MR. HOPPER: Dr. El Sohly's extract, the
21 THC extract, is non-botanical marijuana. Any of
22 the cannabinoids that have been isolated for--
1 JUDGE BITTNER: But then they're no longer
2 marijuana, are they?
3 MR. HOPPER: That is a bit redundant,
4 isn't it?
5 JUDGE BITTNER: It seems so, unless it's--perhaps
6 it's just for emphasis. Okay.
7 MR. HOPPER: Not at all. I'm open to
8 suggestions about a better way to make that
9 distinction. I'm merely trying to distinguish
10 between the synthetics and the extracts versus the
11 whole plants.
12 JUDGE BITTNER: Right. Okay. I got you.
13 MR. BAYLY: Your Honor, may I comment?
14 Just to make things clear, the problem is synthetic
15 is really part of a marijuana, it's synthetic.
17 MR. BAYLY: And yet you can extract from
18 the marijuana different cannabinoids and I don't
19 think we would characterize them as synthetic.
20 JUDGE BITTNER: Right. I think I
21 understand. We'll hope that I do, since we don't
22 want me to be confused. Now I'm okay. I've got
1 it. It's just the "botanical" that got me
2 confused. Somehow it's easier if you say "plant."
3 I'm thinking, well, maybe there's a fake marijuana,
4 plastic marijuana.
5 Okay, go ahead, Mr. Hopper.
6 MR. HOPPER: Thank you. Thank you, Mr.
7 Bayly.
9 Q Just a few more questions here, Dr. Gust.
10 So you've testified that NIDA has a
11 contract with Dr. El Sohly and the University of
12 Mississippi to cultivate marijuana for research.
13 Right?
14 A Yes.
15 Q But NIDA does not license Dr. El Sohly or
16 the University of Mississippi to permit them to
17 cultivate. Is that right?
18 A Right.
19 Q No license from NIDA.
20 A Correct.
21 Q And isn't it the DEA that's the government
22 entity that's responsible for licensing them to
1 cultivate, do the very same process that Dr. Craker
2 filed an application seeking his own registration?
3 A That's my understanding.
4 Q And as part of that licensing process, is
5 it your understanding that DEA sends someone out to
6 inspect the facility where the marijuana's going to
7 be grown and the space where it's going to be
8 cultivated is adequate and secure?
9 A I have no--I don't know. I don't know
10 exactly what they do.
11 Q Okay. NIDA doesn't do that, do they?
12 A No.
13 Q And the same is true--I'm sorry. Dr. El
14 Sohly has two sort of non-NIDA registrations, and
15 the same is true with both of those, right? Your
16 answer is in terms of NIDA doesn't license them,
17 NIDA doesn't inspect the facilities, NIDA doesn't
18 evaluate security--
19 A Certainly not.
20 Q --for anything outside the NIDA contract?
21 A Correct.
22 Q And it's DEA, again, not NIDA that does
1 the licensing for Dr. El Sohly to engage in his
2 activities? I'm sorry, you said that you weren't
3 sure.
4 A As far as I know.
5 Q Okay. And isn't it the DEA and not NIDA
6 that sets quotas on the quantities that can be
7 grown under the non-NIDA licenses?
8 A I don't know who sets--I know there are
9 quotas, and those are established under the, some
10 of the international treaties. I'm not sure how--who
11 monitors that and--
12 Q But--I'm sorry. But it's not NIDA? Is
13 that right?
14 A It's not NIDA.
15 MR. HOPPER: Your Honor, could we take
16 another 15-minute break, and then I think we are
17 about done.
18 JUDGE BITTNER: Okay. Fifteen minutes.
19 Off the record.
20 [Recess.]
21 JUDGE BITTNER: On the record.
22 Mr. Hopper.
1 MR. HOPPER: Thank you.
3 Q Dr. Gust, really, just a couple more
4 questions, I promise.
5 JUDGE BITTNER: They all say that, Doctor.
6 MR. HOPPER: This time it's true.
8 Q You testified, Dr. Gust, didn't you, that
9 there are other Schedule I drugs beyond marijuana
10 for which NIDA is the sole source? Is that
11 correct?
12 A Yes.
13 Q But isn't it true that there no
14 requirement as to any of those other drugs that
15 NIDA be the sole source?
16 A I don't know the answer to that.
17 Q Are you aware of any requirement that NIDA
18 be the sole source for any of those other drugs?
19 A No.
20 Q With regard to the PHS review process that
21 we've been talking about, once a protocol has been
22 denied or rejected, disapproved, by the PHS Review
1 Committee, is there any kind of an appeal process
2 available to a researcher?
3 A The general practice of the committee has
4 been that no project is disapproved. It's
5 generally the deficiencies and weaknesses in the
6 proposal are pointed out to the researcher and the
7 approval is denied until such time as those changes
8 are made and protocols are revised and resubmitted
9 and re-reviewed. It's been the general way that
10 the committee has operated.
11 JUDGE BITTNER: And, I'm sorry, this is
12 the PHS committee?
13 THE WITNESS: The PHS committee.
15 Q And is it your understanding that that is
16 going to continue to be the procedure?
17 A Yes, my understanding is that that will
18 continue.
19 Q And with regard to the Chemic application
20 that we talked about, if I told you--are you aware
21 that a letter has been sent from Chemic to the PHS
22 Review Committee rebutting the rationale for PHS
1 having denied its application?
2 A No.
3 Q If I told you that Chemic has sent such a
4 letter, then would it be your understanding that
5 the PHS review will continue and that the PHS
6 Review Committee will take into account the letter?
7 A Yes.
8 Q And can you tell us--do you know if it's
9 the same PHS Review Committee, it's the same
10 people, that will be conducting this continued
11 review as the committee that denied the initial
12 application?
13 A Generally, yes. I mean, there is some
14 turnover as employees perhaps leave the government
15 and so forth, but in general it tends to be the
16 same individuals, yes.
17 Q You testified earlier that your
18 understanding is that generally the time period for
19 review is about three to six months, although
20 there's no time limit. Is that correct?
21 A Yes.
22 Q Can you tell us, then, based on your
1 understanding of the way the system works and
2 familiarity with Chemic's application, when Chemic
3 might expect to hear again from the committee?
4 A Without any additional information, I
5 would say between three and six months.
6 Q Three to six months from the time that the
7 committee received that subsequent communication?
8 A Mm-hm.
9 Q Do you know, Dr. Gust, is there any way
10 for a researcher or for the general public to
11 obtain from PHS the names of, the identity of the
12 people who are actually conducting the peer review
13 of their protocols?
14 A Am I aware of any way that researchers can
15 get those names? No, I'm not.
16 Q Do you know if a research were to request
17 from PHS the names of the committee members who had
18 reviewed that research's protocol, would that
19 information be provided?
20 A I would think so, but I don't know for--I
21 don't know. I would think so.
22 Q And Dr. Gust, you testified, I believe--I
1 just want to make sure I have this clear--that the--well,
2 you testified that there are these two forms
3 of NIH review, actually three forms of NIH review.
4 One is when you apply for funding from NIH, and
5 then the other is the PHS review we've been talking
6 about, and then there's a third ad hoc review that
7 takes place for, I think you said, non-human,
8 animal-type studies? Is that accurate?
9 A Yeah, I would say exactly that and
10 probably also other types of studies that were
11 conducted in humans but were not related to medical
12 applications of marijuana.
13 Q Okay. And was it your testimony that the
14 ad hoc review that takes place, that those reviews
15 are undertaken by non-government employees for the
16 most part, that those are people from the non-government
17 community?
18 A Yes.
19 Q And the PHS Review Committee that you've
20 described to us, that is all government employees.
21 Is that correct?
22 A That's correct.
1 Q But I think you also testified that even
2 the PHS Review Committee is ad hoc in that it is
3 not a standing committee comprised of the same
4 people, but rather those committees are formed on
5 an ad hoc basis depending upon the nature of the
6 protocol that's been submitted. Is that correct?
7 A Yes.
8 MR. HOPPER: That's all we have, Your
9 Honor.
10 JUDGE BITTNER: Ms. Paredes?
11 MS. PAREDES: Yes, thank you, Your Honor.
14 Q Dr. Gust, to your knowledge, when was the
15 last time that NIDA declined to provide marijuana
16 to a medical researcher who did have an FDA-approved IND and
17 DEA registration to conduct the
18 research protocol?
19 A Again, I would say that in general the
20 response of the PHS committee and of NIDA in the
21 past has been not to really deny anybody access to
22 marijuana but to basically point out the
1 deficiencies in the protocol and invite
2 resubmissions. But having said that, there was an
3 instance that was 10 years ago now, where a
4 researcher who had an IND approved was denied or--was denied
5 approval to receive the marijuana from
6 NIDA based upon scientific deficiencies and that
7 researcher declined to revise and resubmit his
8 application. So in effect, it did--it was a
9 denial.
10 Q And--
11 A That was--there's only been one instance
12 of that, to my knowledge.
13 Q And with regard to the Chemic application,
14 to your knowledge does Chemic have an FDA-approved
15 IND?
16 A I do not know.
17 Q Now, when you discuss that the PHS
18 committee doesn't deny applications but invites
19 resubmissions, can you explain a little more what
20 the PHS committee does in terms of inviting
21 resubmissions?
22 A Well, what--the feedback given to the
1 researcher is basically a critique of the proposal
2 pointing out the strengths and weaknesses. And in
3 a case where the recommendation is not made,
4 obviously, the weaknesses outweigh the strengths.
5 The weaknesses are pointed out in those areas of
6 the scientific--or the criteria for review, which
7 are the--as I mentioned before--the scientific
8 significance of the work, the innovativeness, the
9 technical approach, the qualifications of the
10 environment and of the investigators.
11 Q Now, in the past 10 years, can you
12 estimate how many instances NIDA has approved the
13 distribution of marijuana to approved researchers?
14 A How many different researchers have
15 received marijuana from NIDA?
16 Q Yes.
17 A In the last 10 years?
18 Q Yes.
19 A I would say probably dozens. I mean,
20 that's about as close as I can give you, an
21 estimate.
22 Q Mr. Hopper asked you several questions
1 about your knowledge of Dr. El Sohly's growing
2 marijuana outside of the NIDA contract. Do you
3 recall those questions?
4 A Yes.
5 Q Are you aware that Dr. El Sohly's growing
6 marijuana outside the NIDA contract, he actually
7 distributes or transfers marijuana extracts and
8 not--
9 MR. HOPPER: Objection, Your Honor.
10 Leading.
11 JUDGE BITTNER: Sustained. Could you
12 rephrase it, please?
14 Q Dr. Gust, are you aware of what Dr. El
15 Sohly is--the purposes of Dr. El Sohly's growing
16 the marijuana outside the NIDA contract?
17 A I understand that it's to provide an
18 extract of marijuana to a drug company.
19 Q So it's your understanding that he does
20 not transfer--
21 JUDGE BITTNER: Wait a minute.
22 MR. HOPPER: Objection.
1 JUDGE BITTNER: Would you rephrase it,
2 please?
3 MS. PAREDES: I'm sorry, Judge, can you--
4 JUDGE BITTNER: It was heading into
5 leading territory.
6 MS. PAREDES: Okay.
8 Q I'm sorry, Dr. Gust, did you state that it
9 was your understanding it was an extract?
10 A Yes.
11 Q And when did you come by that knowledge?
12 [Pause.]
13 Q If you can recall?
14 A Well, I'm trying to recall. I can't
15 recall specifically, but I have a feeling it was at
16 the time when Dr. El Sohly was drawing up his
17 response to Dr. Craker's petition.
18 Q And are you aware of how many DEA
19 registrations Dr. El Sohly holds?
20 A No, I'm not.
21 [Pause.]
22 MS. PAREDES: Nothing further.
1 JUDGE BITTNER: Any recross?
2 MR. HOPPER: Yes, Your Honor, if we could
3 just have one moment?
4 JUDGE BITTNER: Off the record.
5 [Off the record.]
6 JUDGE BITTNER: Okay, on the record.
9 Q Dr. Gust, you testified just now that the
10 only time that you're aware of that NIDA has
11 refused to provide marijuana to someone with an
12 FDA-approved protocol was 10 years ago. Is that
13 correct?
14 A Yes.
15 Q Do you know the name of that researcher?
16 A Yes.
17 Q Was that Dr. Donald Abrams?
18 A No.
19 Q Who was that researcher?
20 A Ethan Russo.
21 Q Are you aware that Dr. Russo in fact
22 applied twice to the PHS review panel for
1 marijuana?
2 A He never applied to the PHS review panel.
3 Q I'm sorry. Are you aware that Dr. Russo
4 twice submitted protocols to NIDA for accepting
5 marijuana from them?
6 A I'm aware of three applications that Dr.
7 Russo made to NIH.
8 Q Can you tell us the dates of those--
9 A No.
10 Q --the years of those three applications?
11 A No. I can't recall. I can't. Early 19--
12 Q Go ahead.
13 A I think around 1999 was probably the last
14 one.
15 Q Okay, so just to be clear--
16 A Prior--just prior, I believe, to the
17 establishment of the PHS Review Committee.
18 Q Okay. Would it surprise you if I told you
19 that Dr. Russo applied in 1998 with an FDA-approved
20 protocol for NIDA marijuana, was denied by the PHS
21 review process, then applied again in 1999 with a
22 revised protocol which was again denied?
1 A It wasn't to the PHS Review Committee
2 because it didn't exist in 1998. So, what's your
3 question?
4 Q My question is the process that you
5 referred to when you said "10 years ago" is the
6 only instance that you're aware of in which NIDA
7 marijuana was refused to some researcher who had an
8 FDA-approved protocol, was that process PHS review
9 that you're referring to?
10 A No.
11 Q I'm sorry, is that--
12 A I thought the question was what instance
13 did I recall when NIDA did not provide marijuana to
14 a researcher who had an FDA IND approved. I can
15 recall that one instance. And it was denied
16 because Dr. Russo never received--he actually
17 applied, I believe, through the regular NIH grant
18 system initially and went through the review
19 process and did not get--either approved or did not
20 get approved at a fundable score. He did that a
21 couple of times and then I think he did it--once he
22 found an alternate source of funding and did not
1 request government funding was when--and he would
2 have been reviewed through the NIDA ad hoc process,
3 since that was prior to 1999, and similarly there
4 was no recommendation made, or at least the
5 recommendation was not made to go forward given
6 certain weaknesses in the scientific design of his
7 protocol. And at that point, he declined to revise
8 and resubmit.
9 Q So, then, your testimony that you were
10 aware of only one time in which a researcher with
11 an FDA-approved protocol had been denied NIDA
12 marijuana, are you now saying that, in addition to
13 that, you're aware of Dr. Russo, more recently than
14 10 years ago, with an FDA-approved protocol being
15 denied NIDA marijuana?
16 A Yeah, I guess my estimation of time is
17 bad. That's the instance I was thinking of.
18 Q Okay. So the one you were thinking of
19 when you responded--
20 A Yes.
21 Q --to DEA's question was Dr. Russo?
22 A Correct.
1 Q And I'm sorry if you've answered this, but
2 do you recall that there were two--
3 JUDGE BITTNER: No pointing, Mr. Hopper.
4 MR. HOPPER: I'm sorry?
5 JUDGE BITTNER: No pointing.
7 Q Do you recall that there were two--
8 THE WITNESS: There's a strict rule about
9 that.
10 MR. HOPPER: There is, I know. Every time
11 I go to scratch my head, she thinks I'm pointing at
12 someone.
14 Q Dr. Russo in fact applied twice--once in
15 1998, once in 1999--both times with an FDA-approved
16 protocol, both times denied NIDA marijuana. Were
17 you aware of that?
18 A That's probably right, yes. I'm not aware
19 of where in the process he got his IND, but I know
20 that he--at some point in the process, he did get
21 his IND approved.
22 Q And are you aware of Dr. Donald Abrams
1 having submitted an FDA-approved protocol seeking
2 NIDA marijuana? In the early 1990s?
3 A You don't submit an IND requesting NIDA
4 marijuana.
5 Q No, no, I--
6 A So what's your question?
7 Q My question is are you aware that in the
8 early 1990s, Dr. Donald Abrams had an FDA-approved
9 protocol and submitted a request for NIDA marijuana
10 to carry out the research identified in that FDA-approved
11 protocol, and was denied access to NIDA
12 marijuana?
13 A Are you referring to the NIH grant
14 proposal that Dr. Abrams submitted?
15 Q No.
16 A Okay, I'm not familiar with it. I'm only
17 familiar with his NIH grant which he eventually did
18 get funded.
19 Q So the NIH grant to which you were
20 referring, to your knowledge did Dr. Abrams have to
21 modify his research proposal from the initial
22 proposal in order to receive NIH funding?
1 A I hope he did, because generally when you
2 revise a grant proposal you do modify it, yes, to
3 respond to the criticisms that were addressed and
4 identified by the review committee.
5 Q Are you aware that Dr. Abrams initially
6 wanted to study the efficacy of marijuana in
7 treating AIDS patients with AIDS wasting syndrome,
8 was denied funding, and then modified his protocol
9 to examine the dangers, the harms that might be
10 caused by smoking marijuana when you have AIDS, in
11 order to get the marijuana?
12 A I'm not familiar with the specific
13 criticisms nor his responses to that proposal.
14 Q And just to be clear, was your testimony
15 that Donald Abrams was declined funding or declined
16 marijuana?
17 A He was declined funding at that--as I
18 recall, his grant proposal was to NIH to get NIH
19 funding to do a research project. Absent an
20 approved and funded protocol, NIDA would not
21 provide marijuana.
22 Q And you are familiar--we've discussed it
1 already, Chemic's application that's been denied--that
2 didn't require FDA approval because it's not a
3 clinical study, is that correct?
4 A I don't know.
5 Q You have testified that the PHS review
6 process is sort of an ongoing one, that it's not a
7 denial with the door slammed closed but that the
8 committee critiques a protocol and invites changes
9 in order to address those criticisms. Is that
10 correct?
11 A Yes.
12 Q Is it your understanding that the letter
13 that was sent to Chemic Laboratories telling them
14 that their request had been denied invited response
15 from Chemic, invited Chemic to respond to
16 criticisms and continue the dialogue and process?
17 A Am I aware of that? I never saw the
18 letter that went to Chemic.
19 Q Is it your understanding that this process
20 that you have described to us is communicated to
21 the applicants who receive a letter denying them
22 access to the marijuana?
1 A As far as-- Yeah. Yeah. That's my
2 understanding.
3 Q So if the letter to Chemic did not contain
4 such an invitation, would you find that unusual?
5 A Oh, I don't know if it's necessarily an
6 invitation, a direct invitation to revise and
7 submit. I don't think there's any specific
8 language that's required or not required. But in
9 general, the critiques, I know in general what I
10 had said, that they're--they point out strengths
11 and weaknesses and certainly leave the door open,
12 if not--I don't know if you're getting at there was
13 a specific invitation. I don't know.
14 Q What I'm getting at is do you know if an
15 applicant who has been denied access to NIDA
16 marijuana is made aware of the fact that they may
17 continue--
18 A That's certainly been the case, as far as
19 I know. I mean, pretty much--I mean, most of the
20 experience in this committee has been reviewing
21 proposals from the California center, and they
22 certainly have--in the few instances when their
1 proposals have been critiqued and recommendation is
2 not made to provide marijuana, they have been very
3 aggressive and vigorous at doing--at revising their
4 protocols and resubmitting them.
5 Q And you testified just now on direct that
6 in the past 10 years there are a number--you didn't
7 know how many exactly, but a number of times that
8 NIDA has in fact approved and given marijuana to
9 researchers who didn't have NIH funding. Is that
10 correct?
11 A No. I think the question was how many
12 researchers have received marijuana from NIDA,
13 regardless of whether or not there--I didn't pick
14 up that there was distinction between NIH-funded
15 versus not-NIH-funded.
16 Q Okay, so to your knowledge, in the past 10
17 years have there been non-NIH-funded researchers
18 who were granted access to NIDA marijuana?
19 A Yes.
20 Q And were all of those researchers that
21 were part of the CMCR program?
22 A No.
1 Q So you're aware of researchers outside of
2 the CMCR program who were not funded by NIH, who
3 received marijuana through the PHS review process?
4 A Probably prior to the PHS review process,
5 but certainly received marijuana from NIDA in the
6 past.
7 Q Can you tell us approximately how many?
8 A I would say 10, around 10, plus or minus.
9 Q And do you know if any of those were
10 seeking pharmaceutical development of botanical
11 marijuana?
12 A Not to my recollection.
13 Q And were those all clinical studies?
14 A No.
15 Q Were any of them clinical studies?
16 A Yes.
17 Q Can you tell us about how many of them
18 were clinical studies?
19 A Probably the majority. You know, half, at
20 least, were clinical.
21 MR. HOPPER: We have nothing further.
22 JUDGE BITTNER: Any re-redirect?
1 MS. PAREDES: No, Your Honor.
2 JUDGE BITTNER: Dr. Gust, what's your
3 Ph.D. in?
4 THE WITNESS: Psychology.
5 JUDGE BITTNER: Thank you very much. You
6 may step down.
7 [Witness excused.]
8 JUDGE BITTNER: Mr. Bayly, what would you
9 like to do? Talk about an open-ended question.
10 MR. BAYLY: Judge Bittner, that's it for
11 the witnesses for today. We hope Dr. Auslander
12 will be here in the late morning. As I indicated
13 earlier this morning, we're a little concerned
14 about the weather. And as I indicated yesterday,
15 the Government would like the opportunity to go
16 through all the exhibits to indicate on the record
17 which ones are withdrawn voluntarily, which ones
18 have been excluded by order, and which ones have
19 been admitted. Then there's the leftovers we would
20 seek to admit because they would not be admitted
21 through any witnesses per se.
22 And I can do that now, I can do it after
1 lunch, I can do it sometime tomorrow morning.
2 JUDGE BITTNER: How long did you think Dr.
3 Auslander was going to take?
4 MR. BAYLY: Well, he'll be the--the length
5 of his testimony will be the shortest of all
6 witnesses. It's pretty definitely very non-lengthy
7 compared to, certainly, Dr. El Sohly. It will be
8 less than Dr. Gust.
9 MS. CARPENTER: Would it be possible for
10 Dr. Auslander to call--to come in Friday and to do
11 Dr. Voth and Dr. Auslander on the same day?
12 MR. BAYLY: Now, what kind of schedule do
13 you want to do?
14 MS. CARPENTER: I was just wondering if,
15 instead of coming a little bit tomorrow and a
16 little bit Friday, we could just do them both on
17 Friday. I don't know if Dr. Auslander's schedule
18 would allow for that or not, or Dr. Voth's. But
19 I'm just trying to think of how we can combine it
20 so that we're not coming back and forth.
21 MR. BAYLY: Well, I know Dr. Voth is
22 definitely set only for Friday. He can't change
1 because of patients and prior commitments. So--
2 JUDGE BITTNER: Do you want to try calling
3 Dr. Auslander and see?
4 MR. BAYLY: I can try.
5 JUDGE BITTNER: Why don't we just take,
6 like, 10 minutes and do that, and see what happens.
7 MR. BAYLY: All right.
8 MS. CARPENTER: It might sit--I was
9 thinking with the weather, you know, Friday maybe
10 being better than tomorrow. We might have a better
11 shot at getting it all done on time. We can be
12 here whenever the Court wants us to, but it might--
13 JUDGE BITTNER: Let's go off the record.
14 [Off the record.]
15 JUDGE BITTNER: On the record.
16 Mr. Bayly, what did you ascertain?
17 MR. BAYLY: Judge Bittner, I did actually
18 get ahold of Dr. Auslander and at this time he
19 doesn't believe that he can come down here. He
20 would like to leave it for Thursday. However--so I
21 think we'd like to tentatively leave it for
22 Thursday. He'll try to reconfigure his schedule to
1 see if he can come down Friday. If he can, he will
2 immediately notify me and then I would, of course,
3 contact your office. If I can have a contact
4 number for you, I'll notify and then see if we can
5 do it for Friday. But as of now, he said that it
6 would not work. But he'll try to reconfigure.
7 MS. CARPENTER: Okay. That's fine, Your
8 Honor.
9 JUDGE BITTNER: So let's go off the
10 record.
11 [Whereupon, at 12:38 p.m., a luncheon
12 recess was taken to reconvene at 2:00 p.m., this
13 same day.]
1 A F T E R N O O N S E S S I O N
2 (2:01 p.m.)
3 MR. BAYLY: Your Honor, at this time the
4 Government would like to go through its exhibit
5 list. I'd like to be able to confirm that the--I
6 just want to go down the entire list to confirm
7 that it's either admitted or it's been withdrawn
8 either voluntarily or pursuant to an ALJ order or
9 that we seek to admit it.
10 JUDGE BITTNER: All right, well, let's
11 just start, and then if there are any questions--because I
12 don't have a list. I figured--
13 MR. BAYLY: You don't have--
14 JUDGE BITTNER: I don't have a list that
15 shows what I've done, but I do have the filings and
16 orders and stuff here, so if there's any question
17 we can deal with it. Okay.
18 MR. BAYLY: Government Exhibit No. 1 is
19 the UMass application, and that should be admitted
20 already.
22 MR. BAYLY: Two, U.S. application
1 resubmitted. That is admitted already?
3 MR. BAYLY: Three, UMass bulk
4 manufacturing questions response should be
5 admitted?
7 MR. BAYLY: No. 4 is a UMass Federal
8 Register notice, and that has not been admitted in
9 regard to Government Exhibit 4.
10 JUDGE BITTNER: And there is a page number
11 on this at the top--43755, 43756?
12 MR. BAYLY: Yes.
14 MR. BAYLY: Only it's just a one-page
15 exhibit.
16 JUDGE BITTNER: But in the book--I mean,
17 we probably got it. Do you want to see it as
18 printed? Does that matter, Ms. Carpenter?
19 MS. CARPENTER: I'm sorry.
20 JUDGE BITTNER: Do you want to see the
21 printed version? We've probably got it.
22 MS. CARPENTER: My only question is that I
1 have actually three pages. I have a Government's
2 exhibit, and then there's a second document?
3 MR. HOPPER: Which appears to be the
4 printed page, actually, from the Federal Register.
5 MS. CARPENTER: Ah. I have a copy of the
6 pages and then there's a sort of--like it's been
7 taken off-line.
8 MR. BAYLY: Can I see what you have?
9 MS. CARPENTER: Sure. I think it's the
10 same thing that you were just saying, twice.
11 JUDGE BITTNER: I'd rather have the
12 printed page just because--
13 MS. CARPENTER: It looks more like the
14 Federal Register.
15 JUDGE BITTNER: I think that's an age
16 thing for me, that I'm just more used to seeing
17 things in hardcopy.
18 Off the record.
19 [Off the record.]
20 JUDGE BITTNER: We now have the copy of
21 the notice as printed in the Federal Register, so
22 we know where the page break is. Any objection,
1 Ms. Carpenter?
2 MS. CARPENTER: No, Your Honor.
3 JUDGE BITTNER: Okay, Government Exhibit 4
4 is received.
5 [Government Exhibit No. 4
6 received in evidence.]
7 MR. BAYLY: Next, Government Exhibit 5,
8 Dr. El Sohly's comments to the UMass application up
9 front. That is admitted already?
10 MS. CARPENTER: Okay, hold on. You lost
11 me here. Yes.
12 MR. BAYLY: Okay, 6, 7, and 8 are U.Miss.
13 abstracts and they have been admitted.
14 MS. CARPENTER: Correct.
15 MR. BAYLY: Number 9 and No. 10 we are
16 withdrawing voluntarily. I think No. 10 was pasted
17 over one of the contracts anyway, so--
18 JUDGE BITTNER: Okay, so Government 9 is
19 withdrawn?
20 MR. BAYLY: Yes.
21 JUDGE BITTNER: And Government 10
22 withdrawn. Let me give these to you, Mr. Bayly.
1 That way I don't have something I'm not supposed to
2 have.
3 MR. BAYLY: Okay.
4 Number 11, there isn't any. There was
5 originally, but there should be no No. 11.
6 Number 12 and 13 were these U.Miss. NIDA
7 tracts and they should both be in evidence.
8 MS. CARPENTER: Yes. Twelve--I'm sorry.
9 Twelve, 13, yes.
10 MR. BAYLY: Okay. Fourteen is withdrawn.
12 MR. BAYLY: Fifteen is the NIDA bid for a
13 proposal. That should be admitted already.
14 JUDGE BITTNER: Okay. It is.
15 MR. BAYLY: And 16 through 22, I just
16 called them "trip reports." Those are the
17 documents that the various researchers filled out.
18 JUDGE BITTNER: They're all in.
19 MR. BAYLY: All right, No. 23, HHS Fact
20 Sheet Investigating Medical Use of Marijuana, I
21 believe that we are excluding. I think I went over
22 this with Ms. Carpenter and told her that we were
1 excluding it, so that's what we'll do. So that's
2 23, is out.
3 JUDGE BITTNER: I have one question. I'm
4 going to wish I didn't say this. In 24, Government
5 Exhibit 24, I believe it is, there is a reference
6 to a 1997 workshop.
7 MR. BAYLY: Did you say protocol?
8 JUDGE BITTNER: No, to--I'm trying to find
9 it. Okay. On page 3 of Government Exhibit 24,
10 under IV, which was discussed at some length this
11 morning, there's a reference to "clinical studies
12 involving marijuana should include certain core
13 elements, many of which reflect recommendations
14 made by the 1997 NIH workshop." Okay? Now,
15 Government 23, at the bottom of the first page,
16 refers to a 1997 workshop. Does that reference
17 mean anything in terms of whether I need to have
18 this exhibit, or can we just leave it out?
19 I'm not really dying to read any more, you
20 know.
21 MR. BAYLY: The '97 workshop, I think that
22 may have led to--perhaps Respondent's counsel can
1 affirm or deny this, I don't know--but that may
2 have led to the IOM report.
3 JUDGE BITTNER: Okay, which I think we
4 have.
5 MR. BAYLY: Respondent No. 1?
6 MS. CARPENTER: Or 2, right.
7 JUDGE BITTNER: And that is in, right?
8 MR. BAYLY: Yes.
10 JUDGE BITTNER: Okay, so we can get rid of
11 Government 23?
12 MR. BAYLY: Yes.
13 MS. CARPENTER: Yes. I think Exhibit 25--isn't
14 that the workshop?
15 JUDGE BITTNER: Oh, it may be.
16 MS. CARPENTER: But that's been excluded
17 as well. Government's withdrawn that.
18 JUDGE BITTNER: Okay. I just wanted to be
19 sure that we didn't run into the problem I
20 sometimes have of we take things out and then
21 discover there's a big hole.
22 MS. CARPENTER: Right.
1 JUDGE BITTNER: Okay, Government 23 is
2 withdrawn today. Okay. Mr. Bayly, you can have
3 it.
4 MR. BAYLY: Okay. I'll load it up here
5 with superfluous documents.
6 And 24 should already be admitted.
8 MR. BAYLY: Twenty-five we're going to--
10 MR. BAYLY: --not offer that, really.
11 JUDGE BITTNER: Okay, so let me give you
12 this one.
13 MR. BAYLY: Twenty-six and 27 are some RTI
14 manufacturing statistics, and we would like to
15 admit those two exhibits.
16 JUDGE BITTNER: Ms. Carpenter?
17 MS. CARPENTER: I think that's fine, Your
18 Honor. Let me just check.
19 That's fine, Your Honor.
20 JUDGE BITTNER: Okay. Received.
21 [Government Exhibit No. 26
22 received in evidence.]
1 JUDGE BITTNER: Let's see, that's 26. And
2 the heading on it is on RTI letterhead and it says
3 Manicured Plant Material Received, et cetera.
4 That's 26.
5 And 27 is Marijuana Cigarettes Produced at
6 RTI. Right? Just so we make sure I have the right
7 documents. Okay.
8 And, Ms. Carpenter, you don't have any
9 objection to that one either?
10 MS. CARPENTER: I'm sorry, to which one
11 Your Honor?
12 JUDGE BITTNER: Twenty-seven. Twenty-six
13 I think you said you did not have any objection.
14 MS. CARPENTER: Do not have to either one.
15 JUDGE BITTNER: Okay, 27 is received.
16 [Government Exhibit No. 27
17 received in evidence.]
18 MR. BAYLY: Twenty-eight is another trip
19 report for a Dr. Lichtman [ph], and I have that's
20 been admitted.
22 MR. BAYLY: Twenty-nine is a letter from
1 Frank Sapienza, the former head of ODE, so it's a
2 DEA letter to Dr. Craker. We would seek to admit
3 29.
4 JUDGE BITTNER: According to my notes, you
5 already did.
6 MS. CARPENTER: I think it already is in,
7 Your Honor.
8 MR. BAYLY: Okay. Then 30 is Dr. Craker's
9 Response to Frank Sapienza Letter, so we would--if
10 that's not admitted, we'd like to--
11 JUDGE BITTNER: It's in.
12 MR. BAYLY: It's in, okay.
13 MS. CARPENTER: I think there was a 30-A
14 and 30-B that were added in, do you recall?
16 MS. CARPENTER: Thirty-A was a copy of the
17 article and 30-B was a response to that letter.
18 JUDGE BITTNER: Okay. Yes. So 30 is the
19 June 2, 2003, letter from Dr. Craker to Mr.
20 Sapienza. Thirty-A is an article from the San
21 Mateo County Times.
22 MS. CARPENTER: That was enclosed with
1 that letter.
2 JUDGE BITTNER: And 30-B is a letter from
3 Dr. Russo to Mr. Sapienza.
4 MS. CARPENTER: Right. Also enclosed with
5 that letter. So it's the letter with the two
6 enclosures.
7 JUDGE BITTNER: Okay, all of those were--oh, wait
8 a minute. I don't show 30-B as received.
9 Nicole?
10 THE CLERK: I do, actually, August 24th.
11 JUDGE BITTNER: Oh, you're good. Okay.
12 On August 23rd or 24th, did you say?
13 THE CLERK: Twenty-fourth. The other two
14 are August 23rd.
15 JUDGE BITTNER: Okay, thank you.
16 Okay, whipping right along.
17 MR. BAYLY: Yeah, I wanted to make sure we
18 have the attachments, and we do. So that's 30, 30-A
19 and 30-B should be admitted.
20 And then 31 is some testimony of Nora
21 Volkow of NIDA. This looks like Hill testimony, so
22 we want to admit Government Exhibit 31.
1 JUDGE BITTNER: Ms. Carpenter?
2 MS. CARPENTER: That's fine, Your Honor.
3 JUDGE BITTNER: And--well, you know what?
4 Page 3 is cut off. Do you have a better copy?
5 MS. CARPENTER: My page 3 is fine.
6 JUDGE BITTNER: Okay. Nicole, would you
7 make some copies of this, please. And it's a
8 three-page document, right?
9 MS. CARPENTER: That's what I have. And
10 I'm sorry, Ms. Carpenter, presumably you didn't
11 have any objection since you--
12 MS. CARPENTER: No, I do not. That's
13 fine.
14 JUDGE BITTNER: Okay. Government 31 is
15 received. We'll just fix it.
16 [Government Exhibit No. 31
17 received in evidence.]
18 MR. BAYLY: I guess I was going to hold up
19 until we got our complete copy, or should I
20 continue?
21 JUDGE BITTNER: No, no--well, let's wait a
22 minute. Off the record.
1 [Off the record.]
2 JUDGE BITTNER: So we've got 31 all
3 squared away and it's received. Okay?
4 Next.
5 MR. BAYLY: Thirty-two are the--they're
6 just California statutes and they concern the CMCR.
7 JUDGE BITTNER: Okay. And I have it--wait
8 a minute, hold on. The page is out of order.
9 Okay, I just had pages 4 and 5 out of
10 order.
11 Okay, five pages. Ms. Carpenter, any
12 objection?
13 MS. CARPENTER: No, ma'am.
14 JUDGE BITTNER: Okay. Government 32 is
15 received.
16 [Government Exhibit 32
17 received in evidence.]
18 MR. BAYLY: All right, and then to--33 is
19 a CMCR press release announcing the marijuana
20 research proposals. We'd like to admit that.
21 JUDGE BITTNER: February 22, 2001?
22 MR. BAYLY: If I can--I'll confirm that.
1 MS. CARPENTER: Ms. Carpenter, any
2 objection.
3 MS. CARPENTER: I'm just looking at it
4 very quickly, Your Honor, just to see whether there
5 are any issues I saw.
6 We don't have any objection to that, Your
7 Honor.
8 JUDGE BITTNER: Okay, received.
9 [Government Exhibit No. 33
10 received in evidence.]
11 MR. BAYLY: Okay, then we're on to 34. I
12 think we admitted that.
13 JUDGE BITTNER: Oh, that's in, yes.
14 MR. BAYLY: Then 35.
15 JUDGE BITTNER: Okay, it's a copy of part
16 of 42 U.S. Code Section 241. Somebody has a
17 terrible printer. It's 10 pages.
18 MR. BAYLY: This is a copy of statutes
19 relating to research and investigations generally
20 of drugs.
21 MS. CARPENTER: Okay. I assume this is
22 just for the Court's convenience. Typically one
1 doesn't submit statutes as exhibits.
2 JUDGE BITTNER: Right, but actually I'd
3 rather have it as an exhibit because then I know
4 what to call it.
6 JUDGE BITTNER: As opposed to just taking
7 official notice of it and then having to write out
8 the whole thing ever time we want to talk about it.
9 MS. CARPENTER: Ah. Well, if we have
10 statutes that we want to cite, should we then
11 submit them to you as exhibits? I just want to do
12 whatever is going to make it easiest for Your
13 Honor, but I--
14 JUDGE BITTNER: Oh, thank you.
15 Not necessarily. But we don't have the
16 whole--I have the U.S. Code online. My
17 computerized research skills are--what do they say
18 when you take a physical?--"needs improvement?" So
19 I think for something like this, it's convenient,
20 but--
21 MS. CARPENTER: Or we could even submit
22 copies with the pleading, if that would be helpful.
1 JUDGE BITTNER: Right. Okay.
2 Okay, Government 35 is received.
3 [Government Exhibit No. 35
4 received in evidence.]
5 MR. BAYLY: It would be my understanding,
6 Judge Bittner, that--hypothetically, let's say--if
7 this were incomplete and there was another section,
8 certainly Respondent could cite that.
9 MS. CARPENTER: Oh, sure.
10 MR. BAYLY: As well as the Government. So
11 it is more for convenience.
12 JUDGE BITTNER: Okay, now...
13 MR. BAYLY: Thirty-six, we might as well
14 hold off on that. Dr. Voth will be here, should be
15 here Friday.
17 MR. BAYLY: Thirty-seven, we are not going
18 to introduce that.
19 Thirty-eight, if I could have a second.
20 [Pause.]
21 MR. BAYLY: --is an article, but we're
22 going to--that may or may not come in through Dr.
1 Voth, so we'll hold off on that as well.
3 MR. BAYLY: Thirty-nine we are not
4 introducing.
5 Forty and 41, those are articles that we
6 may be introducing through Dr. Voth, so we'll hold
7 off on those.
8 JUDGE BITTNER: Okay, 40 and 41?
9 MR. BAYLY: Right.
11 MR. BAYLY: Forty-two is withdrawn.
13 MR. BAYLY: We are introducing 43. It's
14 called Report on Rare Diseases Research, NIDA.
15 Really, the only relevant part of this, we're
16 introducing for pages 9-10. There's a little
17 discussion about marijuana abuse and treatment. So
18 we want to introduce Government 43 on that basis.
19 JUDGE BITTNER: Ms. Carpenter?
20 MS. CARPENTER: Your Honor, I think we
21 would object just on relevance as to what
22 medications development for cannabis-related
1 disorders would have to do with this hearing. It's
2 certainly not relevant to any of the statutory
3 factors. It's not relevant to Dr. Craker's
4 application. So if we could just get a statement
5 of that.
6 [Pause to review document.]
7 JUDGE BITTNER: I think--therefore I am--that this
8 issue came up earlier with respect to
9 evidence of potential for abuse. Didn't it? And I
10 don't remember when.
11 Let's go off the record while I try to
12 find this.
13 [Off the record.]
14 JUDGE BITTNER: Respondent has objected to
15 Government Exhibit 43, and my determination is that
16 the last two paragraphs on page 9 of the exhibit,
17 under the heading Medications Development for
18 Cannabis-related Disorders, and those two
19 paragraphs start, respectively, "The treatment of
20 cannabis-related disorders" and the second
21 paragraph starts "Sufficient research has been
22 carried out," I believe those two paragraphs are
1 relevant and the rest of the document is not. But
2 in order to show where it came from, I'll keep the
3 entire document in the file but I'm only going to
4 consider those two paragraphs. Okay?
5 Let's go on to the next brilliant ruling.
6 MR. BAYLY: All right, Your Honor, just
7 for the record we want to argue that all four
8 paragraphs should be admitted. And I understand
9 the two on 9 are admitted and the two on page 10
10 are not. Is that correct?
12 MR. BAYLY: Then we will move on to
13 Government Exhibit 44--oh, I'm sorry. I wrote
14 "page 9" on that.
15 JUDGE BITTNER: That's okay.
16 MR. BAYLY: So that's my copy.
17 JUDGE BITTNER: Okay, page--I'm sorry,
18 Exhibit 44.
19 MR. BAYLY: First of all, 44 we seek to
20 admit now. It's a Federal Register publication on
21 a notice of the denial of petition concerning
22 marijuana. I call it the "Gedman petition." Some
1 of the objections to 43 by Respondent may spill
2 over into this petition, but it's--if I may, Judge
3 Bittner, I'd like to point out what--
4 MS. CARPENTER: Can I just address what
5 you think my objections are?
6 JUDGE BITTNER: First see if there's any
7 objection. Okay.
8 MS. CARPENTER: I might cut you short.
9 JUDGE BITTNER: Okay, Ms. Carpenter.
10 MS. CARPENTER: Our view of this was this
11 is--you know, it's part of the public record, it's
12 a decision, and it's citable. So I wouldn't object
13 to a particular part of that.
14 The other document was more of a private
15 agency document. It may be public record, but it's
16 not part of the--you know.
17 JUDGE BITTNER: So you're not objecting to
18 44?
20 JUDGE BITTNER: Okay, it's received.
21 [Government Exhibit No. 44
22 received in evidence.]
1 MR. BAYLY: Thank you. You save me--
2 JUDGE BITTNER: Then you could have a
3 peroration.
4 MR. BAYLY: I just want to mark on page 9,
5 44 admit.
6 JUDGE BITTNER: Okay, we're up to 45.
7 MR. BAYLY: This is a--yes, we seek to
8 admit this article as well. It is a publication,
9 however--it doesn't appear that it is published in
10 the Federal Register, but it's the National Drug
11 Intelligence Center, National Drug Threat
12 Assessment 2005. And I've got the whole document
13 in here, but only the part that talks about
14 marijuana, obviously, is relevant.
15 MS. CARPENTER: Based on Your Honor's
16 previous ruling--I mean, we had moved to exclude
17 this one, I believe, and it was not excluded. So
18 we just stand on that objection. But--
19 JUDGE BITTNER: Okay. Government 45 is
20 received.
21 [Government Exhibit No. 45
22 received in evidence.]
1 MR. BAYLY: Forty-six is the AMA stance on
2 medical marijuana, and I believe, Judge Bittner,
3 you excluded that under your last order. So that's
4 out.
5 JUDGE BITTNER: Okay. So I'll give it
6 back to you.
7 MR. BAYLY: Forty-seven--do we have 47?
8 This is another publication by the National MS
9 Society Information Sourcebook. The reason that we
10 seek to admit this document is that it has got a
11 discussion on Sativex.
12 JUDGE BITTNER: Oh, Sativex, the--
13 MR. BAYLY: Sativex. S-a-t-i-v-e-x. And
14 it also mentions the latest Supreme Court case. I
15 guess that's the Raich case, which we may be using
16 that in the brief. That's the one where the--the
17 interstate commerce issue.
18 JUDGE BITTNER: Okay. Ms. Carpenter?
19 MS. CARPENTER: I'm sorry, the only
20 relevance is that it mentions Sativex? Is that why
21 you want to put it in?
22 JUDGE BITTNER: No, and there was also
1 something else Mr. Bayly just said.
2 MR. BAYLY: It mentioned Sativex and the
3 Raich case. And the Sativex, there's been a number
4 of discussions--I mean, there's been a number of
5 testimony on it, so I feel it should go in.
6 MS. CARPENTER: Well, Your Honor, I guess
7 I--there certainly has been a lot of testimony on
8 Sativex, but I'm not sure that's sufficient reason
9 to admit any document that happens to mention it.
10 And I think generally the rest of this document is
11 certainly about the therapeutic benefits or lack
12 thereof, and I think it's in that context that
13 they're talking about Sativex. The Supreme Court
14 ruling sort of stands on its own, so I'm not sure
15 why this document would come in. And I guess if it
16 does come in, we might like to introduce some
17 updated information, you know--
18 JUDGE BITTNER: Story of my life.
19 MS. CARPENTER: --from these same
20 organizations about recent studies that have been
21 done.
22 MR. BAYLY: I think, Judge Bittner, we can
1 limit this document to--
2 MS. CARPENTER: If there's going to be
3 witness testimony about that, I'm not sure--which I
4 assume there is, from the prehearing statements--I'm not
5 sure why this document would be necessary
6 or--
7 JUDGE BITTNER: Okay. The problem is, I'm
8 really not going to know until I read everything.
9 So at this point, I'll admit with the
10 understanding, which you just all need to be aware
11 of, if when I go through the record I conclude that
12 it doesn't tell me anything, I won't consider it--it doesn't
13 tell me anything that it ought to tell
14 me, put it that way.
15 So with that caveat, 47 is received.
16 [Government Exhibit No. 47
17 received in evidence.]
18 MR. BAYLY: Forty-eight, it looks like
19 that was the exhibit that was excluded by your
20 latest ruling, Judge Bittner.
21 JUDGE BITTNER: Yes. Okay, here you go.
22 MR. BAYLY: We were hoping to avoid noise
1 by the construction downstairs in the new
2 cafeteria; instead, we have window washers.
3 JUDGE BITTNER: It's considerably better
4 than the cafeteria noise, trust me.
5 Okay, 49.
6 MR. BAYLY: Let's see. This is an
7 article, and it's entitled Who Become Cannabis
8 Dependent Soon After Onset of Use. Epidemiological
9 evidence from the U.S. 2000-2001--
10 JUDGE BITTNER: This is the one I said I
11 would not exclude.
12 MS. CARPENTER: That's right. So we're
13 not going to argue now, but I just want to be clear
14 that, for the record, we stand on the objections we
15 made.
16 JUDGE BITTNER: Okay. Well, I'll overrule
17 the objection and it is received.
18 [Government Exhibit No. 49
19 received in evidence.]
20 MR. BAYLY: Fifty was excluded by your
21 order, Judge Bittner.
22 JUDGE BITTNER: Here you go, Mr. Bayly.
1 Off the record.
2 [Off the record.]
3 JUDGE BITTNER: Okay. We're up to 51.
4 MR. BAYLY: Yes. We're withdrawing that.
5 52 and 53. 52 is a document concerning
6 Sativex. It's what I call a Canadian version of
7 the PDR. It just describes the product, so I think
8 we would, again, need to have something in the
9 record on this inasmuch as it's been referred to in
10 quite a bit of the direct and cross, of the
11 testimony.
12 JUDGE BITTNER: Ms. Carpenter, any
13 objection?
14 MS. CARPENTER: Well, that's part of 53,
15 but there's actually additional sections.
16 JUDGE BITTNER: Wait a minute. We're on
17 52.
18 MS. CARPENTER: Oh, I'm sorry. Did I jump
19 ahead. Oh, yes. No objection, Your Honor.
20 JUDGE BITTNER: Received.
21 [Government Exhibit No. 52
22 received in evidence.]
1 MR. BAYLY: And 53, I first want to go
2 through it and make sure that respondents and Your
3 Honor have each part of this exhibit. It's like a
4 composite. The first page is a fax transmittal
5 from a Ms. Mead to a Christine Beato.
6 JUDGE BITTNER: Okay. And there's a cover
7 sheet and a letter of four pages?
8 MR. BAYLY: Right. There is a cover
9 sheet, and then, right, there's a letter of four
10 pages. And then after that is the Office of Public
11 Health and Science Office of Executive Secretariat.
12 That's actually faxed to me. I don't know if that
13 needs to be in there.
14 MS. CARPENTER: Isn't the letter in?
15 MR. BAYLY: Yes, it looks there may be two
16 copies.
17 JUDGE BITTNER: It certainly looks like
18 it.
19 MR. BAYLY: Yes. It looks like there's
20 some superfluous material I here. Really, what
21 we're only seeking to admit, this fax cover sheet
22 and the letter, which goes from page 2 in the top
1 right corner, through page 5.
2 JUDGE BITTNER: Okay. And then the other
3 stuff. Let me give you that. I assume you don't
4 want the second copy and the fax to you, right, Mr.
5 Bayly?
6 MR. BAYLY: Right.
7 JUDGE BITTNER: Let me give you that back.
8 MS. CARPENTER: I guess my concern here is
9 that this is clearly a response to something, to a
10 letter. It's a response under the Data Quality
11 Act, wishes to provide clarification concerning
12 several of the studies cited in the ASA's request
13 for correction. And I guess I would ask that we
14 have the opportunity to put that in to respond, so
15 that the context of the letter is complete, because
16 without knowing what they're responding to, it's a
17 little hard to have the context that this is
18 answering.
19 JUDGE BITTNER: Oh, okay. Ms. Mead is
20 with GW Pharmaceuticals.
21 MS. CARPENTER: Right.
22 JUDGE BITTNER: I had them backwards,
1 okay. And Dr. Beato is with GW Pharmaceuticals.
2 MS. CARPENTER: She's with the--
3 JUDGE BITTNER: Oh, no, she's with--
4 MS. CARPENTER: Health and Human Services.
5 JUDGE BITTNER: Okay, got it. So the
6 question is?
7 MS. CARPENTER: The letter from Ms. Mead,
8 you know, clearly says this is--we're sending this
9 in response to another document, and she's
10 referring in part to that other document, so I
11 guess in order to keep the record complete, we
12 would like the opportunity to get that other
13 document, or maybe the DEA has it and would combine
14 that with this exhibit.
15 JUDGE BITTNER: Mr. Bayly?
16 MR. BAYLY: I'm just looking to see if
17 there's something in here that might answer this.
18 Request for correction of information submitted to
19 the Department of Health and Human Services by the
20 ASA on October 4th, 2004 under the Data Quality
21 Act. That's something that I would have no
22 objection to supplementing the record with in terms
1 of the context of this. I don't know that it
2 necessarily would preclude this from being admitted
3 right now because this document, of course, has
4 been hanging around for quite a while, so either
5 the government or the respondent could have
6 obtained this earlier to supplement our record.
7 But if, Judge Bittner, you want us or respondent to
8 get this--
9 JUDGE BITTNER: I think I would like you
10 to get the comments from ASA to which this letter
11 responds. That's under the provision of providing
12 additional documents, which in fairness should be
13 considered with--wherever it is.
14 MR. BAYLY: I have no objection to that if
15 that's the--
16 JUDGE BITTNER: So I'll withhold ruling on
17 53 until we get the comments to which it responds.
18 MR. BAYLY: Okay.
19 JUDGE BITTNER: 54 is in.
20 MS. CARPENTER: I'm sorry. We're on 54,
21 Your Honor?
22 JUDGE BITTNER: Yes, it is received, was
1 received in August.
2 MS. CARPENTER: Right. I actually had a--I spoke
3 to Mr. Bayly about that this morning. We
4 have a--oh, no, I'm sorry, that's a different one.
5 We have a supplemental exhibit, a substitute
6 exhibit with more signatures, but it's not this
7 letter, it's one of the others. I'll hold off
8 until that comes up.
9 JUDGE BITTNER: 55, Mr. Bayly.
10 MS. CARPENTER: So 54 was admitted?
11 JUDGE BITTNER: That was admitted in
12 August.
13 MS. CARPENTER: Yes, that's right.
14 JUDGE BITTNER: 55 is a letter from then-
15 Administrator Hutchinson.
16 MR. BAYLY: Are we on 54?
17 JUDGE BITTNER: 54 was admitted in August.
18 MR. BAYLY: Okay. But this is the new--
19 MS. CARPENTER: That's a different letter.
20 It's not 54.
21 MR. BAYLY: Right, okay. And then 55, I
22 don't think that's been admitted, but that's simply
1 the response to 54.
2 JUDGE BITTNER: Any objection?
4 JUDGE BITTNER: Received.
5 [Government Exhibit No. 55
6 received in evidence.]
7 JUDGE BITTNER: Okay. 56.
8 MR. BAYLY: Well, 56 through 59 have been
9 voluntarily withdrawn.
11 MR. BAYLY: 60, that was excluded, Judge
12 Bittner, by your last order.
14 MR. BAYLY: Last order pertaining to the
15 admission of evidence.
16 JUDGE BITTNER: Okay, here it is.
17 MR. BAYLY: 61 is another Federal Register
18 DEA adjudication concerning marijuana called Church
19 of the Living Tree.
21 MS. CARPENTER: I would object to that on
22 relevance.
2 MR. BAYLY: This Federal Register does
3 talk about the deleterious effects of using
4 marijuana, so at the very least, I would say that
5 it should be admitted on that basis. Certainly,
6 the government should be given an opportunity to
7 argue.
8 JUDGE BITTNER: I would say it shouldn't
9 be an exhibit though. I mean you can cite it in a
10 brief. It was a summary disposition, so I think I
11 would exclude it. If you want to cite it in your
12 brief, that's fine. I mean, obviously, I have
13 access to it. So I'm going to give this to you
14 too. Oh, well, actually, do you want me to reject
15 it formally, or how do you want to handle this?
16 MR. BAYLY: Yeah, let's do it that way.
17 JUDGE BITTNER: Do you want me to keep it
18 in the file so it can be submitted to the
19 administrator?
20 MR. BAYLY: Yes.
21 JUDGE BITTNER: Okay. So Government 61 is
22 rejected.
1 [Pause.]
2 JUDGE BITTNER: Okay. 62 we're up to.
3 MR. BAYLY: Right. That's just a copy of
4 the Supreme Court case, U.S. v. Oakland Cannabis
5 Buyers Co-op.
6 JUDGE BITTNER: Ms. Carpenter?
7 MS. CARPENTER: I'm sorry.
8 JUDGE BITTNER: Government 62 is the
9 Supreme Court decision.
10 MS. CARPENTER: Right. And, again, I
11 think as a court decision it's citable if it's
12 convenient for the Court to have it int.
13 JUDGE BITTNER: That's the only reason.
14 Okay, received.
15 [Government Exhibit No. 62
16 received in evidence.]
17 JUDGE BITTNER: Then when you cite it you
18 can put Government 62 in parentheses, and you know
19 that I have no excuse for not having it, not that I
20 had any excuse anyway.
21 MS. CARPENTER: On that, would it be
22 helpful, Your Honor, if when we cite cases for us
1 just to make a binder to send with our brief?
2 JUDGE BITTNER: Oh, my gosh, would you
3 really?
4 MS. CARPENTER: We would do that. In
5 fact, I did that for a Federal judge just two days
6 ago.
7 JUDGE BITTNER: Yes, it would. I mean I'm
8 not going to require it, but, yes, it would.
9 MR. BAYLY: That would be what, citing
10 the--
11 JUDGE BITTNER: The cases that you cite,
12 just send to me. Gee, that would be terrific.
13 That could start a very serious precedent.
14 MR. HOPPER: Start requiring that in all
15 of your cases.
16 JUDGE BITTNER: We won't go there. Okay,
17 63.
18 MR. BAYLY: Yes, that's another Federal
19 Register. This is an adjudication concerning Dr.
20 Marion "Molly" Fry. Molly Fry sounds like a rock
21 band, but it is a physician, and this Federal
22 Register was an adjudication which I think revoked
1 her registration or denied her application. It
2 does talk about marijuana abuse by physicians, and
3 describes some marijuana abuse facts. So in that
4 sense, we think it's relevant and should be
5 admitted.
6 JUDGE BITTNER: Ms. Carpenter?
7 MS. CARPENTER: Just one second, Your
8 Honor. Let me just look at this quickly. I've
9 looked at it before, but to refresh my--I had
10 thought this one was excluded, but I see that it
11 wasn't. I think we moved--we moved to exclude this
12 one. Was this one that the Court decided to leave
13 in, or did we not move to exclude this one?
14 JUDGE BITTNER: Let me see.
15 MS. CARPENTER: I guess in the same sense
16 that it's a citable decision from the DEA, we don't
17 object to having it as a--but I guess we do object--we
18 object to it being an exhibit on relevance
19 grounds.
20 JUDGE BITTNER: All right. Well, I think
21 I should probably try to be consistent, so on the
22 same grounds as the Church of the Living Tree
1 decision, I'll reject it, but it stays in the file
2 and goes to the deputy. [Phone ringing.] Is that
3 you?
4 MR. BAYLY: I'm sorry, I apologize. May I
5 take a quick break?
6 JUDGE BITTNER: Yes. Off the record.
7 [Recess at 3:02 p.m.]
8 JUDGE BITTNER: We were on Government
9 Exhibit 63, and Ms. Carpenter objected on grounds
10 of relevance, and I sustain the objection, but I'm
11 assuming that Mr. Bayly wants it to remain in the
12 file so it will be transmitted to the Deputy
13 Administrator; am I correct?
14 MR. BAYLY: Oh, yes, absolutely. I feel
15 pretty strongly this needs to go in if we're
16 talking about marijuana abuse and the effects of
17 abuse. I think that was pretty clear in your
18 order, Judge Bittner--
19 JUDGE BITTNER: I'm going to have to say
20 what my real problem is, and my real problem is
21 that these are cases that--at least this one--that
22 were not decided on the basis of a record, but on
1 the basis of an investigative file.
2 MR. BAYLY: Okay.
3 JUDGE BITTNER: So that's my underlying
4 problem. And I think, although Church of the
5 Living Tree is a little more complicated, I believe
6 that--I maybe wrong about this, but that again,
7 much of the discussion was based on an earlier case
8 involving the same respondent that was again
9 decided on the basis of a file. So you can argue
10 the extent to which cases that are not based on a
11 litigated record and not a summary disposition
12 should have weight. That's an open issue at the
13 moment, I think.
14 So Government 63 is rejected and will go
15 to the deputy.
16 MR. BAYLY: Judge Bittner, for the record,
17 the reason why we would like to have these two as
18 exhibits is, number one, hearsay's admissible, and
19 maybe it's hearsay on an investigative file, but
20 that's still proper hearsay. Secondly, we do want
21 to retain the right to argue that these should be
22 considered on the merits even if they are what I
1 loosely call "default" orders. So we want the
2 opportunity to present that argument to you, Judge
3 Bittner, to reconsider, and we want the
4 opportunity, of course, then for the Deputy
5 Administrator.
6 JUDGE BITTNER: Right, understood.
7 MR. BAYLY: With that, I will move on.
8 JUDGE BITTNER: Okay. 64.
9 MR. BAYLY: That's the UN's World Drug
10 Report 2004.
11 MS. CARPENTER: We don't have any
12 objection to that, Your Honor.
13 JUDGE BITTNER: 64 is received.
14 [Government Exhibit No. 64
15 received in evidence.]
16 JUDGE BITTNER: 65, 66, 67, 68, 69, 70,
17 71, are all in. 72, Mr. Bayly.
18 MR. BAYLY: Those are withdrawn, 72 and
19 73.
20 JUDGE BITTNER: Okay. 74 is in, as is 75,
21 76, 77 and 78, and 79. We're up to 80.
22 MR. BAYLY: 80, 81 are withdrawn. 82 we
1 do seek to admit.
2 JUDGE BITTNER: Okay, hold on a second.
3 MS. CARPENTER: Your Honor, I think this
4 is one we had objected to, Your Honor, and I think
5 Your Honor overruled our objection.
6 JUDGE BITTNER: Was it even or odd?
7 [Laughter.]
8 JUDGE BITTNER: Okay. So 82 is still
9 objected to, but I overrule the objection, and it's
10 received. Okay.
11 [Government Exhibit No. 82
12 received in evidence.]
14 MR. BAYLY: That's Dr. Auslander's CV. I
15 can withhold on that because he'll be testifying
16 from it, or I can admit it now. I know it will be
17 admitted, but I guess I could just hold off until
18 he testifies.
19 MS. CARPENTER: Fine with me to admit it
20 now.
21 JUDGE BITTNER: Okay. Let's get it off
22 the list. So you have no objection, Ms. Carpenter?
1 MS. CARPENTER: No, we have no objection.
2 JUDGE BITTNER: Okay. Government 83 is
3 received.
4 MS. CARPENTER: Just to be clear, no
5 objection just to the exhibit. We're not
6 stipulating to his expertise in anything.
8 [Government Exhibit No. 83
9 received in evidence.]
10 MR. BAYLY: Right. No, understand that
11 respondent can voir dire.
13 MR. BAYLY: This is another Federal
14 Register. It's the marijuana scheduling petition,
15 and since there was some cross-examination of Dr.
16 Doblin, I believe, on some of the factors in this,
17 we would seek to admit this into evidence.
18 MS. CARPENTER: Your Honor, I thought the
19 Court's order was pretty clear that scheduling is--
20 rescheduling is not before the Court and that's not
21 the issue.
22 JUDGE BITTNER: I think it's useful as
1 background, however, so I'll receive it. I don't
2 know if I have it anywhere else. I probably do,
3 but, okay, 84 is received.
4 [Government Exhibit No. 84
5 received in evidence.]
6 MR. BAYLY: It looks like we're about
7 finished here.
9 MR. BAYLY: 85 through 91 are withdrawn.
11 MS. CARPENTER: 85 through what? I'm
12 sorry, Your Honor.
13 MR. BAYLY: 91.
15 [Pause.]
16 JUDGE BITTNER: Okay. I don't have a 92
17 either.
18 MR. BAYLY: It was one of these
19 supplementals, so it was attached to a
20 supplemental--
21 JUDGE BITTNER: Let me give you the big
22 bear back.
1 [Laughter.]
2 JUDGE BITTNER: And let me see whether 92
3 is--
4 MS. CARPENTER: I think it's the fourth
5 supplemental.
6 JUDGE BITTNER: Government's fourth,
7 obviously.
9 JUDGE BITTNER: Can you give me a date?
10 MS. CARPENTER: Yes, that would have been
11 August 18th.
12 JUDGE BITTNER: Oh, my heavens, I'm months
13 off. Fourth. And it's an affidavit by Dr.
14 Throckmorton.
15 MR. BAYLY: Yes.
17 MS. CARPENTER: Your Honor, I guess I have
18 one comment on that, which is in that he refers to
19 a document there on page 5, and in particular he's
20 talking about regulation of botanicals. We've had
21 that document. It's been referred to several
22 times, and I guess I would--we could either submit
1 it as one of our exhibits, or maybe it makes sense
2 to append it to this one, but he does specifically
3 refer the Court to that in his affidavit, so I
4 think it's important to get that in.
6 MR. BAYLY: I don't think we have an
7 objection to that being admitted. In fact, it may
8 be referred to by Dr. Auslander.
9 JUDGE BITTNER: Can you get it, Mr. Bayly,
10 and attach it, and I'll withhold ruling on this?
11 MS. CARPENTER: I think we have some
12 copies if the Court would like to do it now.
13 JUDGE BITTNER: Oh, do you have it? Oh,
14 super.
15 MR. HOPPER: Our copy has some
16 highlighting.
17 MS. CARPENTER: Oh, no, I think we've got
18 a plain one.
19 MR. HOPPER: I don't know if we have
20 enough for everyone, but I think we have one. We
21 can get a few copies. Well, look at that.
22 JUDGE BITTNER: Okay. So could we call
1 this 92 and 92A?
2 MR. BAYLY: Yes.
3 JUDGE BITTNER: I usually don't like to do
4 that, but since it's already been marked. And, Mr.
5 Bayly, you are offering both?
6 MR. BAYLY: Yes.
7 JUDGE BITTNER: And, Ms. Carpenter?
8 MS. CARPENTER: No objection.
9 JUDGE BITTNER: Received.
10 [Government Exhibits Nos. 92
11 and 92A received in evidence.]
12 JUDGE BITTNER: And 93 is received. And
13 94 was received. I think you're done, Mr. Bayly.
14 MR. BAYLY: Yes.
15 JUDGE BITTNER: I'm sorry. What was 94,
16 Your Honor?
18 MR. BAYLY: Was the document used to
19 refresh Dr. El Sohly's recommendation--recollection.
20 JUDGE BITTNER: Okay, thank you.
21 So, Ms. Carpenter, would you like to go
1 through a similar exercise?
2 MS. CARPENTER: Yes, Your Honor, except I
3 think I must have missed one of Mr. Bayly's because
4 we had a substitute for that and I was waiting for
5 it, and I must have missed it. Let me just see if
6 I can figure out which one that was.
7 JUDGE BITTNER: Mr. Bayly, do you have a
8 list of yours? It was that letter dated--to
9 Administrator Tandy from the--there were five House
10 of Representative signatories, and I'm pretty sure
11 that was a government exhibit. Did I just miss it?
12 Okay. There was the letter to Mr. Hutchinson.
13 That was the only letter in the government's batch.
14 MS. CARPENTER: It is one of our exhibits.
15 Okay, so we'll update our own exhibit.
16 JUDGE BITTNER: All right.
17 MS. CARPENTER: Thank Your Honor.
18 [Pause.]
19 MS. CARPENTER: Do you want me to go
20 through the names of each document or just--I kept
21 them by list of a number, but I don't have the--
22 JUDGE BITTNER: I don't think it's
1 necessary to go through the names unless we run
2 into a problem. I mean I can just tell you what
3 I've got.
5 JUDGE BITTNER: Number One is the
6 Application--
7 MS. CARPENTER: That was the Institute of
8 Medicine Report?
9 JUDGE BITTNER: Yeah. I just want to make
10 sure I've got the applications right. This is date
11 stamped June 28th, 2001, as Respondent 1.
12 MS. CARPENTER: No, I don't--
13 JUDGE BITTNER: Date stamped by--
14 MS. CARPENTER: Is that the administrative
15 exhibits?
16 JUDGE BITTNER: I'm looking at--sorry.
17 Wrong set of exhibits. I thought I had everything
18 together. I apologize.
19 MS. CARPENTER: Quite all right.
20 JUDGE BITTNER: That was a lovely
21 reference to the government exhibits. Okay. Let's
22 try this again. I was wondering why you all looked
1 kind of discombobulated here. We try again.
2 Respondent Institute of Medicine Report.
3 MS. CARPENTER: Yes. Is that admitted?
5 MS. CARPENTER: And Number 2, the Single
6 Convention was admitted?
8 MS. CARPENTER: Number 3, Curriculum Vitae
9 Law Curriculum was admitted?
11 MS. CARPENTER: Number 4--should I just do
12 numbers? Would that be shorter?
15 JUDGE BITTNER: Because we--yeah.
16 MS. CARPENTER: Four is admitted? I had
17 five as admitted--six, seven, eight, nine, 10 are
18 admitted.
19 JUDGE BITTNER: Okay. I don't have--I
20 don't show 10 as admitted. That's Dr. Ginspoons--
22 JUDGE BITTNER: Is that 10?
1 MS. CARPENTER: Oh, no, you're right. I'm
2 sorry.
3 JUDGE BITTNER: So that was excluded?
4 MS. CARPENTER: Yep, excluded. Right. It
5 was offered and excluded.
6 JUDGE BITTNER: It was rejected?
8 JUDGE BITTNER: Okay. So do you want it
9 to go to the Deputy Administrator?
11 JUDGE BITTNER: Okay. Then I won't get it
12 back to you.
14 JUDGE BITTNER: Do we know when I did
15 this? 10. Okay. It will be in the transcript.
16 MS. CARPENTER: I'm sorry. What do you
17 need? Oh, yes.
18 JUDGE BITTNER: Okay. We just need to
19 look for the date of when I rejected. I think I
20 did it--I excluded it in her document, so I don't
21 think you ever actually offered it.
22 MS. CARPENTER: That's correct, Your
1 Honor. The government moved to exclude testimony--
3 MS. CARPENTER: --and exclude it as a
4 witness.
5 JUDGE BITTNER: So are you offering it
6 now?
7 MS. CARPENTER: So we would offer it now.
8 Yes.
9 JUDGE BITTNER: Okay. And Mr. Bayly is
10 objecting to it, and I'm rejecting it. So I'm
11 rejecting it as of today.
13 JUDGE BITTNER: Okay. Just so when the
14 Deputy Administrator gets this stuff, she knows
15 what I did when.
17 JUDGE BITTNER: Okay. Eleven is received;
18 so is 12.
19 MS. CARPENTER: And that's--we have
20 a--there was a substitute for that one. I just
21 want to make sure the court had the signed copy.
1 MS. CARPENTER: Okay. Great.
2 JUDGE BITTNER: Okay. All right. I'm
3 showing ruling withheld, and that's no longer the
4 case?
5 MS. CARPENTER: Right. Because we had a
6 substitute.
7 JUDGE BITTNER: Okay. So I'm just going
8 to throw that out.
10 JUDGE BITTNER: So it's not so confused.
11 Okay. Thirteen is received.
12 MS. CARPENTER: Thirteen was admitted.
13 Fourteen.
14 JUDGE BITTNER: Fourteen.
15 MS. CARPENTER: Fifteen?
16 JUDGE BITTNER: Sixteen I excluded.
17 MS. CARPENTER: Sixteen, 17, 18 you
18 excluded.
19 JUDGE BITTNER: So do you want to offer
20 them or just take them back?
21 MS. CARPENTER: I think we'd like to offer
22 them. Let me just take a look. If you could have
1 one--just one second, Your Honor. Your Honor, I
2 think we'll leave those in, just so the record is
3 complete.
4 JUDGE BITTNER: Okay. So you want as
5 expected?
6 MS. CARPENTER: That's right.
7 JUDGE BITTNER: Okay. So that Respondent
8 16 is rejected. And you want it to go to the
9 Administrator, Deputy Administrator?
10 MS. CARPENTER: That's correct.
11 JUDGE BITTNER: Seventeen is also
12 rejected.
13 MS. CARPENTER: That's right.
14 JUDGE BITTNER: Eighteen also rejected.
15 MS. CARPENTER: That's correct.
16 JUDGE BITTNER: And 19--
17 MS. CARPENTER: Was admitted for limited
18 purposes I think.
21 JUDGE BITTNER: Okay. Twenty was
22 excluded?
1 MS. CARPENTER: Twenty was rejected under
2 the same ruling.
3 JUDGE BITTNER: So you want it rejected
4 the same way?
5 MS. CARPENTER: Yes, Your Honor.
6 JUDGE BITTNER: Twenty-one, the same
7 thing?
8 MS. CARPENTER: Yes, Your Honor. And then
9 22 the same thing.
10 JUDGE BITTNER: Okay. Also rejected.
11 Okay. Twenty-three?
12 MS. CARPENTER: Twenty-three. Your Honor,
13 I guess I have--there is some of this evidence that
14 we are not going to introduce. I guess some of it
15 we may want to use with Dr. Voth if he goes or is
16 allowed to go places where we don't think he's
17 allowed to go under the order, so I would say for
18 purposes now, we would withdraw it. But we would
19 certainly want to be able to use those--
20 JUDGE BITTNER: But let's just not do
21 anything--
22 MS. CARPENTER: Not address it now. And
1 that makes sense.
2 JUDGE BITTNER: Okay. Twenty-four--
3 MR. BAYLY: Your Honor, just for the
4 record, I would say for the exhibits that we
5 withdrew or rejected, we may find other ways that
6 they would be admissible, too, so I don't think
7 either party is precluded from reintroducing on
8 maybe perhaps other grounds and for what they
9 excluded.
10 JUDGE BITTNER: Oh, sure. Sure. Yeah,
11 no. This makes reading the record so much more
12 interesting. Okay. Respondent Exhibit 24?
13 MS. CARPENTER: The same thing I think,
14 Your Honor. We would just hold off on that one.
15 JUDGE BITTNER: Okay. Twenty-five.
16 MS. CARPENTER: Twenty-five would be the
17 same.
18 JUDGE BITTNER: Okay. Twenty-six I
19 withheld ruling on August 24th. We're going to
20 keep--oh, what did I finally do with that? Oh.
21 Right. What did we do? Okay. Off the record.
22 What we need to--
1 [Recess.]
2 JUDGE BITTNER: We're on the record. With
3 respect to Respondent's Exhibit 26 by a Memorandum
4 to Counsel on Ruling on November 29th of this year,
5 I received it. So it's in.
6 MS. CARPENTER: Thank you, Your Honor.
7 And just to be clear--
8 MR. BAYLY: For the record that we would
9 like to renew the objections that we submitted in
10 the written ones where you subsequently overruled,
11 but we do want to ask you to reconsider, and we
12 resubmit the objections.
13 JUDGE BITTNER: Okay. I'll deny the
14 motion to reconsider, but the Deputy Administrator
15 will get the whole thing. So and--maybe it
16 wouldn't hurt to point that out right now that I
17 don't--at the end of the case, after I issue my
18 decision and I submit everything to the Deputy
19 Administrator, I don't send every piece of paper
20 that got filed. But I do send everything that
21 didn't get subsumed into the hearing or
22 post-hearing filings. So at this point, I don't
1 know what I will send in terms of all of these
2 supplemental pre-hearing statements. But I would
3 just like to note that when I send the whole thing
4 to the Deputy Administrator, I write her a letter.
5 I send her a list of what she's getting, and I send
6 you both, counsel, a copy of the letter and the
7 list.
8 MS. CARPENTER: Okay. Thank you, Your
9 Honor. That's good to know.
10 JUDGE BITTNER: So you just need to know
11 that, and please when you get this letter from me,
12 take a look at it and see if I missed anything.
13 MS. CARPENTER: Thank you, Your Honor.
15 MR. BAYLY: Judge Bittner, would this be
16 appropriate time or perhaps later to ask you to
17 include some of these items in the record, like
18 we've reviewed the objection here, so the record
19 would need to have the newly submitted evidence or
20 a document with the affidavits, and I guess
21 respondent may have filed a motion with that, and
22 then our response and your ruling?
1 JUDGE BITTNER: Well, see, that sort of
2 thing I would normally send.
3 MR. BAYLY: Okay.
4 JUDGE BITTNER: What I don't send are
5 things like routine requests for extensions of
6 time. And where I'm going to run into needing to
7 look at things are, for example, if we have a
8 filing that I normally would not send, but then in
9 a subsequent filing that's disputed, there's a
10 reference back to that one. And that's why you
11 need to look at the list.
13 JUDGE BITTNER: And obviously, in your
14 briefs, you can point out things that you really
15 feel I need to send that I might otherwise not.
16 But, by and large, I send almost everything.
19 MS. CARPENTER: Just for the record, Your
20 Honor, should that affidavit then be part of
21 Exhibit 26, or would you just rather have it
22 separate? How should we refer to that?
1 JUDGE BITTNER: I think for this purpose,
2 it can be separate, because I will be sending that
3 supplemental pre-hearing statement to her.
5 JUDGE BITTNER: Otherwise, the Deputy
6 Administrator is going to get something that's
7 referenced in one way up until a certain date, and
8 the has a different reference after that.
10 JUDGE BITTNER: And that's confusing.
11 MS. CARPENTER: Okay. So should we make
12 that a separate exhibit, then, at the end?
13 JUDGE BITTNER: It will go with your--
14 MS. CARPENTER: With the hearing, with the
15 supplemental statement?
17 MS. CARPENTER: Great. Okay.
18 JUDGE BITTNER: Okay. Whipping right
19 along. Twenty-seven?
20 MS. CARPENTER: Twenty-seven I think would
21 be in the same category of hold until testimony is
22 over.
1 JUDGE BITTNER: Twenty-eight is in.
2 MS. CARPENTER: Twenty-eight is in.
3 Twenty-nine, 30, 31, 32, and 33 I have in?
5 MS. CARPENTER: Thirty-four we will
6 withdraw.
8 MR. BAYLY: Thirty-four is withdrawn?
9 MS. CARPENTER: Yes. Thirty-five is
10 withdrawn. Thirty-six is withdrawn. Thirty-seven
11 is withdrawn. Thirty-eight is withdrawn.
12 Thirty-nine, Your Honor, although we have not used
13 it, it is simply a copy of the Federal Register
14 report as to the license being granted that there
15 was considerable testimony about, and we would
16 submit that.
17 JUDGE BITTNER: Mr. Bayly, any objection?
18 MR. BAYLY: Federal Register notice, no.
19 JUDGE BITTNER: Okay. Received.
20 MS. CARPENTER: So let me just make this
21 clear. So thirty--and then the same for 40, Your
22 Honor.
1 JUDGE BITTNER: You're offering it?
2 MS. CARPENTER: Yeah. Forty, 41. I think
3 those were all the same category. Forty-two.
4 JUDGE BITTNER: Okay. Mr. Bayly, any
5 objection to Respondent 49?
6 MR. BAYLY: No.
7 JUDGE BITTNER: And 40, what? I'm sorry.
8 Forty is received. Let me--and 41, Mr. Bayly?
9 MR. BAYLY: No objection.
10 JUDGE BITTNER: Received.
11 MS. CARPENTER: And then 42, Your
12 Honor--the same.
13 JUDGE BITTNER: Mr. Bayly?
14 MR. BAYLY: No objection.
15 JUDGE BITTNER: Received. Okay. Okay.
16 Forty-three is in?
17 MS. CARPENTER: Yes, ma'am.
18 JUDGE BITTNER: This may be the letter
19 you're talking about.
20 MS. CARPENTER: This is the one.
22 MS. CARPENTER: No, actually. That's the
1 one that I believe that government--that was the
2 government exhibit. There's another one that--
3 JUDGE BITTNER: Okay. So are you offering
4 44? There was a question. I have a note on here
5 signed copy.
6 MS. CARPENTER: And I have clear up the
7 date. But let me just check--I think it came in
8 under the government's exhibits, and so we did not
9 end up getting another copy. Let me just check
10 that.
11 JUDGE BITTNER: Yes, it's the order to
12 show cause. It's the same as ALJ-1. Okay. We
13 need another copy of 43. Oh, never mind.
14 MR. BAYLY: Is 43 admitted?
16 MS. CARPENTER: Sorry, Your Honor, I just
17 don't have a list of the--there it is. Nope. Your
18 Honor, instead of taking your time, could I just
19 hold off on that one?
21 MS. CARPENTER: And I'll figure out.
22 JUDGE BITTNER: Forty-five. Thank you.
1 MS. CARPENTER: Forty-five we will
2 withdraw.
4 MS. CARPENTER: Forty-six we will
5 withdraw. That may have been--was that excluded?
6 JUDGE BITTNER: I don't remember.
7 MS. CARPENTER: I don't, either. Could we
8 check the order on that?
9 JUDGE BITTNER: See that was the August
10 12th order?
11 MS. CARPENTER: Yes, that would be the
12 August 12th order. Your Honor, I don't see in
13 your--
14 JUDGE BITTNER: I think that it was
15 excluded. I didn't refer to it, and I don't know
16 why.
17 MS. CARPENTER: I don't know--if maybe the
18 government didn't move to exclude it. But in any
19 event, we would offer it.
20 JUDGE BITTNER: Okay. Mr. Bayly, do you
21 have a position on Respondent Exhibit 46?
22 MR. BAYLY: If I could just have a brief
1 look through, please?
2 JUDGE BITTNER: Sure. You want to go off
3 the record?
4 [Recess.]
5 MR. BAYLY: I think we can go back on the
6 record.
7 JUDGE BITTNER: On the record?
8 MR. BAYLY: Yeah. Judge Bittner, I have
9 some objections to this. First of all, what we're
10 talking about a completely different country. This
11 is obviously the U.K. and not the United States.
12 And secondly, it looks like this publication gets
13 into a lot of collateral and irrelevant issues as
14 well.
15 I know it gives some history on marijuana,
16 and I don't believe that's going to be relevant,
17 since it is pretty old history. We've got the IOM
18 report, so there may be some duplication of that as
19 well. And I really don't see where this is going
20 to add anything to the record on the decision to
21 grant or not grant the application.
22 JUDGE BITTNER: Okay. Ms. Carpenter?
1 MS. CARPENTER: Well, Your Honor, I guess,
2 you know the fact that it's from England might also
3 exclude all the information from Sativex, since
4 that's from England as well. So I'm not sure
5 that's a ground for excluding it. But I think the
6 reason we had offered it was even simply as
7 background material as to the development of
8 marijuana and would submit that it's relevant for
9 that purpose.
10 JUDGE BITTNER: I haven't read it, so I'm
11 going to have to do that. So I will withhold
12 ruling on this.
13 MR. BAYLY: I would point, Judge Bittner,
14 that, for example, Chapter 5 talks about medical
15 uses, so I know that wouldn't get in, because
16 that's been--that kind of evidence has been
17 excluded by your previous order, so--
19 MR. BAYLY: I don't know. I'm objecting
20 to the whole thing, and perhaps we can revisit
21 this. There may be parts that the court will admit
22 and other parts that will not be admitted.
1 JUDGE BITTNER: Okay. I will read it at
2 some point. Okay. So ruling is withheld on that
3 one. Forty-seven.
4 MS. CARPENTER: Yes, Your Honor, that's a
5 curriculum vitae of Rodney Skager. I do not expect
6 we would be calling on him. He was a potential
7 rebuttal witness, but I guess we should hold that
8 open.
10 MS. CARPENTER: And, in the event that
11 something pops up we need him for.
12 JUDGE BITTNER: Okay. Forty-eight?
13 MS. CARPENTER: That would be relevant to
14 the same witness, so if you could withhold that one
15 as well.
16 JUDGE BITTNER: Okay. Forty-nine.
17 MS. CARPENTER: Forty-nine. Your Honor, I
18 think we do submit that.
19 JUDGE BITTNER: Okay. Mr. Bayly?
20 MR. BAYLY: If I may just. Okay. No
21 objection to that.
22 JUDGE BITTNER: Okay. Received. Fifty is
1 in. Is that the one that you have the update of?
2 MS. CARPENTER: Yes, it is.
4 MS. CARPENTER: Yes, and I had given a
5 copy earlier to Mr. Bayly. This is the exact same
6 letter, but instead of they're now 38.
7 JUDGE BITTNER: Ah. Okay. Mr. Bayly, any
8 objection to substituting the new Respondent 50?
9 MR. BAYLY: Well, if they can get 200 more
10 representatives and 51 in the Senate we can move
11 this hearing out, but--
12 [Laughter.]
13 JUDGE BITTNER: Well, the only thing
14 is--you know.
15 MR. BAYLY: I--just for the record, can we
16 stipulate, and I'm not absolutely sure, but I
17 strongly suspect that the Congressmen and
18 Congresswomen that signed this may be from the
19 Democratic Party. Just a wild guess.
20 [Laughter.]
21 MS. CARPENTER: For the record, there are
22 two Republicans.
1 MR. BAYLY: Hooray.
2 JUDGE BITTNER: Let's not stipulate as to
3 party affiliation. If you do, somebody will
4 switch. Okay. You're willing to accept the
5 substitute?
6 MR. BAYLY: I am willing to allow this to
7 come in, but I don't want any more to come in.
8 Perhaps they may be able to persuade a few more
9 Republicans to sign this letter a little later, but
10 I think we should cut it off here.
11 JUDGE BITTNER: Well, at the moment,
12 anyway. We'll see again if they get another 200.
13 MR. BAYLY: There's the 2006 elections,
14 and I really don't want to go there. This is fine,
15 though.
16 JUDGE BITTNER: All right. The substitute
17 for Respondent 50 is received.
18 MS. CARPENTER: Thank you, Your Honor.
19 JUDGE BITTNER: And, Nicole, do you have a
20 copy for me? Do you have a copy for me, Ms.
21 Carpenter?
22 MS. CARPENTER: Oh, I thought I gave. I
1 have a copy, the official copy.
2 JUDGE BITTNER: But I need a copy for me
3 so I know who these.
4 MS. CARPENTER: Did I give you an extra
5 one, Mr. Bayly?
6 I had four.
7 I know I had given you one earlier this
8 morning. Did I give you another one now?
9 MR. BAYLY: I remember getting it this
10 morning. I don't remember.
11 JUDGE BITTNER: Well, we can make a copy.
12 It's all right. Don't worry about it.
13 I'm not going to get my feelings hurt.
14 And then in your bound book that you gave me, there
15 is something after this letter, but it doesn't have
16 a little tab on it. Is this Respondent 51?
17 MS. CARPENTER: Fifty-one, which is the
18 letter--
19 JUDGE BITTNER: To Mr. Bayly from?
21 JUDGE BITTNER: Patients Out of Time?
1 JUDGE BITTNER: And what number is that?
2 MS. CARPENTER: That is 51.
3 JUDGE BITTNER: Are you offering it?
4 MS. CARPENTER: Yeah. We'll offer it.
5 JUDGE BITTNER: Mr. Bayly, do you have any
6 objection to it?
7 MR. BAYLY: Well, they misspelled my name,
8 but I guess that's not going to keep it out. No.
9 JUDGE BITTNER: You're not objecting?
10 MR. BAYLY: No.
11 JUDGE BITTNER: Okay. Fifty-one is
12 received.
13 MR. BAYLY: Do we have another copy of
14 that? Fifty-one?
15 JUDGE BITTNER: Now, I've--oh, I've got
16 it.
17 MR. BAYLY: You've got it? Okay.
19 MS. CARPENTER: Yeah. They should have
20 it.
21 JUDGE BITTNER: Okay. And then--and I've
22 got. Your exhibit is kind of squirreled away in
1 various places. It's a problem with doing binding
2 I think. It's so nice, but then what do you when
3 you add something?
4 MS. CARPENTER: Right. That is the
5 problem.
6 JUDGE BITTNER: Okay. I have a 52A that
7 was received.
8 MS. CARPENTER: Right. And 52B.
9 JUDGE BITTNER: And I believe, if I have
10 an A, well, you should have a B.
12 JUDGE BITTNER: And then there's a 53.
13 And that was received yesterday.
14 MS. CARPENTER: Was there a 52A and a 52B?
16 MS. CARPENTER: Okay. Great.
18 MS. CARPENTER: And then 53.
19 JUDGE BITTNER: Right. And that's it so
20 far; correct?
21 MS. CARPENTER: That is. Now, there are a
22 couple of other letters, a couple of other exhibits
1 that I don't know whether we want to talk about
2 those now or?
3 JUDGE BITTNER: I--okay. I don't have any
4 more.
5 MS. CARPENTER: No, that haven't been--oh,
6 I guess. Let me see the affidavit. We had and I
7 sort of offer this based on what you said earlier
8 today. We'd add some testimony from it. It comes
9 from a congressional hearing, at which the FDA
10 testified to--at which the FDA testified.
12 MS. CARPENTER: And would offer that again
13 as a matter of convenience for you to have
14 available, if that's convenient for you or we can
15 just cite to it and attach a copy of it as you
16 prefer.
17 JUDGE BITTNER: Now, Mr. Bayly, do you
18 have this?
19 MR. BAYLY: I'm sorry.
20 MS. CARPENTER: Do we even have another
21 copy. I'm not sure we do.
1 MS. CARPENTER: Oh, we do? Okay.
2 JUDGE BITTNER: Okay. Let's go off the
3 record. Could I see it?
4 [Recess.]
5 JUDGE BITTNER: Respondent 54 is testimony
6 by Dr. Meyer before the Committee on Government
7 Reform of the House of Representatives on April
8 1st, 2004. And ruling is we're just holding on to
9 that while Mr. Bayly has an opportunity to study it
10 and see if he objects.
11 MS. CARPENTER: And then along the same
12 lines and these are--there may be objections to
13 these. There's been a lot of testimony about the
14 Chemic letter and in Dr. Doblins' testimony there
15 was--that Exhibits 52A and 52B were the Chemic, the
16 letter to Chemic from HHS. We now have a response
17 from Chemic to HHS. And we'll probably tomorrow
18 have another document dated today or tomorrow that
19 is being sent to HHS with regard to that whole
20 incident.
21 JUDGE BITTNER: And maybe we should wait
22 until Friday and--
1 MS. CARPENTER: All right.
2 JUDGE BITTNER: --we'll have a complete
3 package, but that way--at least Mr. Bayly should
4 have it now.
5 MS. CARPENTER: Right. Why don't I go
6 ahead and give you a copy of this right now.
7 MR. BAYLY: You want to mark this as 55?
8 MS. CARPENTER: Right, 55.
9 MR. BAYLY: Okay.
10 JUDGE BITTNER: All right. Then we'll
11 hold off on this.
12 MS. CARPENTER: Okay. And I think that is
13 all.
14 JUDGE BITTNER: I think so, too. We'll
15 get this complete--disaster area here. Okay.
16 Anything else before we adjourn for the day? Mr.
17 Bayly?
18 MR. BAYLY: No, Judge Bittner.
19 JUDGE BITTNER: Ms. Carpenter?
20 MS. CARPENTER: No, Your Honor.
21 JUDGE BITTNER: Nine o'clock Friday
22 morning?
1 MR. BAYLY: Yes.
2 JUDGE BITTNER: Okay. Thank you all very
3 much. Have a nice evening.
4 [Whereupon, at 3:45 p.m., the hearing was
5 adjourned to reconvene at 9:00 a.m., Friday,
6 December 16, 2005.]