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0754
1 UNITED STATES DEPARTMENT OF JUSTICE
2 DRUG ENFORCEMENT ADMINISTRATION
3
4 - - - - - - - - - - - - - - - x
:
5 In the Matter of: :
: Docket No. 05-16
6 LYLE E. CRAKER, Ph.D. :
:
7 - - - - - - - - - - - - - - - x
8
VOLUME IV
9
10 Thursday, August 25, 2005
11 DEA Headquarters
600 Army Navy Drive
12 Hearing Room E-2103
13 Arlington, Virginia
14
15 The hearing in the above-entitled matter
16
17 reconvened, pursuant to adjournment, at 9:05 a.m.
18
19 BEFORE:
20
21 MARY ELLEN BITTNER
22 Chief Administrative Law Judge
0755
1 APPEARANCES:
2 On Behalf of the DEA:
3 BRIAN BAYLY, ESQ.
Office of Chief Counsel
4 Drug Enforcement Administration
Washington, D.C. 20537
5
IMELDA L. PAREDES, ESQ.
6 Senior Attorney
Office of Chief Counsel
7 (202) 353-9676
8 On Behalf of the Respondent:
9 JULIE M. CARPENTER, ESQ.
Jenner & Block LLP
10 601 13th Street, N.W.
Suite 1200 South
11 Washington, D.C. 20005
(202) 661-4810
12
M. ALLEN HOPPER, ESQ.
13 Senior Staff Attorney
Drug Reform Project
14 American Civil Liberties Union Foundation
1101 Pacific Avenue, Suite 333
15 Santa Cruz, California 95060
(831) 471-9000 Ext. 14
16
ALSO PRESENT:
17
18 MATTHEW STRAIT
19 Representative of the Government
20
21 Richard Doblin, Ph.D.
22 Representative of Respondent
0756
16 800 800
17 836 836
18 843 843
19 852 852
20 858 858
21 880 880
22 887 887
28 (previously) 905
29 788 788
0757
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. Mr. Bayly.
3 MR. BAYLY: Well, before we actually get
4 started with any proceedings, I wanted to talk
5 about scheduling issues, Judge Bittner, and we can
6 do that on or off the record.
7 JUDGE BITTNER: Let's go off the record.
8 [Discussion held off the record.]
9 JUDGE BITTNER: Back on the record. Mr.
10 Bayly, your opening, if you want. You don't have
11 to.
12 MR. BAYLY: Well, yeah, I've prepared an
13 opening and I'd like to do it now, Judge Bittner.
14 JUDGE BITTNER: Okay.
15 MR. BAYLY: We might as well start
16 although I realize that it's unlikely any of us
17 will remember one word of it come September, but--
18 JUDGE BITTNER: Oh, Mr. Bayly, don't
19 underestimate me.
20 MR. BAYLY: We may have the transcript
21 available. Judge Bittner, you've already gotten a
22 preview of a number of the issues in the testimony
0758
1 based upon what we've heard this week from
2 Respondent's witnesses, both on direct examination
3 as well as cross-examination. And you'll be
4 getting more details on the process and some
5 conflicting testimony with the Respondent's
6 witnesses from some of the Government's witnesses.
7 Other testimony will pretty much be in
8 sync with what you've already heard. You will hear
9 from various witnesses from HHS as well as DEA
10 about this so-called NIDA contract. The NIDA
11 contract, and that stands for the National
12 Institute of Drug Abuse, is the contract that is
13 made with the University of Mississippi and the
14 Research Triangle Institute.
15 Now, NIDA is a component of HHS. That's
16 Department of Health and Human Services. And NIDA
17 has this contract with the University of
18 Mississippi, and the contract is every five years.
19 And you've already heard, Judge Bittner, that Dr.
20 Craker testified that he received a notice of this
21 contract so he could put a bid on it.
22 Now, this contract has been in effect many
0759
1 years, and the entity that has been awarded this
2 contract is the University of Mississippi, which is
3 now the sole supplier of marijuana to researchers,
4 and that marijuana is also given to the
5 compassionate use patients who use it for various
6 reasons, although there's a sunset provision on
7 that Compassionate Use Program, also called
8 Experimental Use Program.
9 I believe there was already testimony or,
10 if not, there will be testimony that the
11 Compassionate Use Program is going to be terminated
12 once the people who are on it now are no longer on
13 it for whatever reason.
14 In any event, this five-year contract was
15 open for bids in 2004, and it was awarded, I should
16 say re-awarded to the University of Mississippi in
17 2005. The government will put in evidence the
18 contract itself, both in 2004 and the 1990 contract
19 as well.
20 Now, this contract with the University of
21 Mississippi is not solely with the University of
22 Mississippi. The contract as will be explained by
0760
1 various HHS witnesses is rolled into a contract
2 with the Research Triangle Institute in North
3 Carolina. Now, their part in the scheme in a very,
4 very basic summary is to--they're like a middleman.
5 They receive the marijuana from the University of
6 Mississippi. They'll roll it in cigarettes, and
7 then they'll deliver it to the appropriate
8 researchers who--all these participants in this
9 scheme are DEA registrants.
10 Now you'll also be hearing from these same
11 witnesses that the researchers, if they want to
12 obtain marijuana from the University of
13 Mississippi, they need to submit a protocol. Now,
14 it's simply not a protocol to NIDA itself because
15 NIDA, as the acronym stands for National Institute
16 of Drug Abuse, that's what they look at, but back
17 in '98-99--the witnesses will have a more precise
18 time frame than I do here--but they will testify
19 that the protocols for these researchers were going
20 to have to be reviewed by a committee from the
21 Public Health Service, so that they would look at
22 various issues.
0761
1 And Judge Bittner, as you recall, an
2 exhibit, and I don't know if it was admitted--I
3 think it was admitted on behalf of the Respondent.
4 It may have been the Government, but in any event,
5 there was a company called Chemic that has
6 submitted a protocol, and this Chemic wanted, as
7 the testimony came out yesterday, I believe, Chemic
8 wanted to get a protocol approved from the Public
9 Health Service, and their protocol was to research
10 or do some research on a vaporizing device on
11 marijuana and they were seeking to obtain marijuana
12 from the University through the NIDA contract and
13 also seeking to import marijuana from Holland to do
14 comparison studies.
15 And as the exhibit demonstrates, there was
16 a committee, which consists of various people from
17 HHS, the Public Health Service and NIDA as well,
18 looked at the protocol and at this time they denied
19 the protocol, and I believe the letter of denial is
20 as recent as August 17, 2005. So I don't think
21 either party really anticipated this coming at this
22 time, although we did anticipate it. We just
0762
1 didn't anticipate it coming in at this time. But
2 nevertheless, that letter demonstrates an idea of
3 how the protocol system operates.
4 Now, not too surprisingly, Judge Bittner,
5 you'll also hear from Dr. ElSohly, and he is the
6 head of the--the Director of the University of
7 Mississippi project to cultivate marijuana, and he
8 will testify how the process works, what they can
9 do, how they can adjust the levels of THC, how they
10 can destem and deseed the marijuana, what they've
11 done to address that issue.
12 He'll explain the process of the marijuana
13 getting to the researchers. He'll explain that the
14 complaints, if any, have not impacted or have any
15 negative hindrance on the University of Mississippi
16 being able to supply a sufficient quality and
17 quantity to the researchers who are doing clinical
18 research, and of course clinical research again
19 being research on humans.
20 Dr. ElSohly will also explain that he
21 obtained another DEA registration in order to work
22 with Mallinckrodt, and I'm sure that's a name
0763
1 you're familiar with, Judge Bittner. That's a
2 major manufacturing company, and he did obtain
3 permission from DEA to work with Mallinckrodt on
4 producing an extract which Mallinckrodt seeks to do
5 studies and launch a product which for lack of a
6 better term I'll term "natural dranabinol."
7 What that entails is Dr. ElSohly doing the
8 extracts needed to then transfer the extracts from
9 the cannabis to Mallinckrodt, who then launched the
10 IND and testing of this, and are ready to actually
11 launch a product.
12 The witnesses from NIDA will also testify
13 that--from HHS--that the complaints that they've
14 received about the University of Mississippi
15 marijuana have been virtually nonexistent.
16 You've already heard some testimony about
17 the CMCR, so that will be also explained as well,
18 and it will be explained, Judge Bittner, that the
19 Medical Marijuana Research Act of 1999 was passed
20 in California, and this created the CMCR, and these
21 were for researchers to look into clinical studies
22 of marijuana.
0764
1 And in addition to the--of course, they
2 need to receive their marijuana through the NIDA
3 contract via RTI, originating at the University of
4 Mississippi. So they submit protocols, and for the
5 most part their protocols have been approved, but
6 they also have to go through certain state
7 procedures as well before they are allowed to
8 conduct clinical research.
9 So there are a number of hurdles, but
10 nevertheless, you'll find out that a number of
11 researchers are very active, or at least as the
12 testimonies show, until the money runs out for now.
13 I think we did hear testimony--I believe it was Dr.
14 Gieringer--one of the witnesses--testified that the
15 budget had been cut, but that they still have
16 current operating funds, and when they run out, I
17 guess it's anybody's guess if they can get those
18 renewed by the California legislature or perhaps
19 even get private funding.
20 But, nevertheless, at this point, we know
21 the research continues and we'll have testimony
22 that these researchers, the CMCR researchers, were
0765
1 contacted by two of DEA personnel to actually
2 interview them to find out what was going on with
3 the researchers. DEA knew that Dr. Craker's
4 application was filed at least in part based upon
5 the allegation that the University of Mississippi
6 supplied the researchers with inferior quality
7 marijuana.
8 So, of course the best thing to do was to
9 have the DEA folks go out there and find out. They
10 interviewed the CMCR researchers, and as you'll
11 hear, Judge Bittner, probably not until September
12 now, but there was a number of other persons that
13 they interviewed as well in conjunction with the
14 investigation, and the interviews of the CMCR
15 researchers did not disclose any substantial
16 problems in terms of impeding or hindering the
17 research to such an extent that they couldn't do
18 it, and the researchers, by and large, were
19 satisfied with the marijuana that they obtained
20 from the University of Mississippi.
21 And certainly Dr. ElSohly will be able to
22 testify that any problems that could be encountered
0766
1 in terms of excess seeds or stems can be certainly
2 dealt with by the University of Mississippi, and
3 based on the University of Mississippi's
4 experience, they have more than adequate expertise
5 to deal with the THC levels that researchers
6 require in their research.
7 Now, Helen Kaupang is a DEA witness who is
8 now the Group Supervisor in Denver, Colorado, but
9 she'll testify that she was in a registration unit
10 while these interviews were being conducted and
11 while Dr. Craker's application was being
12 investigated, and she will testify about the
13 process.
14 She'll testify that it's necessary for the
15 DEA to publish the application in the Federal
16 Register. and when that was done so for Dr.
17 Craker's application, Dr. ElSohly submitted some
18 comments which, of course, Dr. ElSohly--comments
19 and objections--and he'll testify about those.
20 In addition, Helen Kaupang will testify
21 that it's standard procedure to issue a set of
22 questions to the applicant that wants to
0767
1 manufacture controlled substances and I believe
2 it's Government Exhibit 3 that the questions and
3 answers by Dr. Craker were answered, and that
4 exhibit has already been admitted into evidence and
5 we already heard Dr. Craker discuss that exhibit.
6 We'll also have Dr. Eric Voth. Dr. Voth
7 is a medical doctor. He is a practitioner that
8 does treat patients. He's also an adjunct
9 professor, and in addition to his medical
10 expertise, he has developed an expertise on
11 marijuana over the past 20 years, particularly a
12 very impressive expertise. He has written a number
13 of articles in this area. He has researched this
14 area. He has participated in a number of debates,
15 seminars, both as somebody who leads them and as a
16 participant.
17 He has in addition to that background,
18 he's looked into the constituents of cannabis and
19 cannabinoids and can testify to a great extent on
20 how marijuana can and cannot be used.
21 Now, the Government also has tendered some
22 witnesses to talk about some of the problems with
0768
1 the what I'll call the state legalized marijuana.
2 I guess as we kind of described it yesterday, it's--I don't
3 know how you describe it--quasi-legal.
4 It's legal under the state, but after Raich v.
5 Gonzales, it's illegal under federal law, but in
6 any rate, there are several witnesses that will
7 testify about the issues entailing marijuana under
8 these circumstances.
9 One is the buyers' club, so-called buyers'
10 club, that was subject to a search warrant in San
11 Bernandino, California. And how the problems
12 there, where the physician was found to have
13 actually authorized the use of marijuana in advance
14 of actually seeing some of these patients. We'll
15 also have some exhibits from the Medical Board of
16 Oregon concerning a Dr. Leveque. That's L-E-V-E-Q-U-E, I
17 believe. In any event, Dr. Leveque was
18 issued a complaint and a suspension order for
19 issuing marijuana recommendations without any
20 proper medical justification under the Oregon law.
21 And then we'll also have Helen Kaupang
22 testify that she was in contact with the Bureau of
0769
1 Narcotics Chief. It's probably a generic name, but
2 it's similar to the Bureau of Narcotics in
3 California. At any rate, he provided Ms. Kaupang
4 as well as ONDCP a number of statistics on the
5 marijuana program where, Judge Bittner, you'll be
6 able to see that out of just a very handful of
7 practitioners, it's roughly--I think it's 107 out
8 of 4,700--something like that--actually do
9 recommend marijuana.
10 However, you'll see that the top three are
11 disproportional in doing so, a huge amount. And
12 that even one of the Hawaiian medical recommenders
13 is now under investigation.
14 We'll also introduce a copy of an
15 affidavit by a Douglas Throckmorton, M.D. He's the
16 Acting Deputy Director for the Center of Evaluation
17 Research at HHS, and under the FDA. So his
18 affidavit will explain the FDA role in this
19 process.
20 The other witness that we have on tap is a
21 Dr. David Auslander, who based on his education and
22 his extensive experience, he is a pharmaceutical
0770
1 drug expert, and he will be talking, if we do call
2 him, he'll be talking about some of the same issues
3 that Dr. Irwin Martin talked about earlier this
4 week, and that is regarding what's needed to bring
5 medical marijuana product to market.
6 We do have quite a few exhibits, Judge
7 Bittner, and I think that does pretty much end up
8 the summary at this point. I do want to say,
9 however, that based on your order, and based on our
10 motion, the Motion in Limine, and the order that
11 you issued, we will be withdrawing some exhibits.
12 In fact, we've been in discussion with Ms.
13 Carpenter about that.
14 And so some of the exhibits will be
15 withdrawn. If we still feel we need to put them
16 in, but Ms. Carpenter feels that--she feels they
17 should be out based on your order, then of course,
18 we'll deal with that when it comes. We also, and I
19 won't make any commitments for anybody here, but we
20 also talked about possibly stipulating to a little
21 bit of the testimony which is noncontested, or
22 noncontroversial, and perhaps the Research Triangle
0771
1 Institute, some of that or all of that, and we do
2 have a Diversion Investigator, James Place, who did
3 talk to Dr. Craker, but his interview to Dr. Craker
4 was limited simply to security issues, and there
5 doesn't seem to be any, at this point, any great
6 controversy there.
7 So I guess that would be another fertile
8 area that we can look into, but in any event I
9 guess one way or another, that evidence would come
10 in. So at this time, I don't have anything to add.
11 However, I represent that there's probably more
12 evidence coming in than I've summarized here,
13 because I know I've taken enough time as it is. I
14 could probably go on quite a bit.
15 We have I think 92 or 93 exhibits. I'm
16 losing count, but as I indicated I think some of
17 those will have to be withdrawn. So that's all I
18 have for now. Thank you very much.
19 JUDGE BITTNER: Thank you, Mr. Bayly. Are
20 you ready to call your first witness?
21 MR. BAYLY: If we could take a five, ten
22 minute break, please.
0772
1 JUDGE BITTNER: Ten minutes. Off the
2 record.
3 [Whereupon, a short recess was taken.]
4 JUDGE BITTNER: Back on the record. Okay.
5 Mr. Bayly.
6 MR. BAYLY: Thank you, Judge Bittner, just
7 to let the Court know, we believe we can finish
8 Matt Strait today.
9 JUDGE BITTNER: Everything?
10 MR. BAYLY: I think so.
11 JUDGE BITTNER: Okay.
12 MR. BAYLY: I just had a discussion with
13 Mr. Strait and co-counsel, Imelda Paredes, and I
14 believe we can finish with her testimony. We would
15 request a somewhat liberal lunch hour just to be
16 able to go over some of the stuff we didn't have a
17 chance to go over with Mr. Strait, and that would
18 complete the testimony.
19 At that point, I don't know where we'll
20 be, but we've agreed that if Respondent Counsel
21 wants to launch into cross-examination at that
22 time, they can. Otherwise, we can adjourn and
0773
1 perhaps finish with the cross-examination tomorrow.
2 I know we have, I believe it's a three-hour session
3 tomorrow.
4 JUDGE BITTNER: That's what we're
5 currently--that was the current arrangement. I'm
6 here. I'm here all day, so--
7 MR. BAYLY: Well, then perhaps, if--
8 JUDGE BITTNER: I have no problem with
9 going later as long as we have a reporter.
10 MR. BAYLY: That might work, because my
11 guesstimate, and again I realize that I've been
12 wrong before on estimating times, but I wouldn't
13 think we'd get much past the lunch hour on cross,
14 would you?
15 MS. CARPENTER: My cross tomorrow, you
16 mean?
17 MR. BAYLY: Yeah.
18 MS. CARPENTER: It sort of depends on what
19 he says today, but I would think we might push to
20 12:30 or one and be done.
21 JUDGE BITTNER: Okay. Again, I'm here.
22 So, all rightie. Are we ready?
0774
1 MS. PAREDES: Yes, Your Honor. The
2 Government calls Mr. Matt Strait for testimony.
3 Whereupon,
4 MATTHEW STRAIT
5 was called as a witness herein and, having been
6 first duly sworn by the Administrative Law Judge,
7 was examined and testified as follows:
8 JUDGE BITTNER: Please be seated and there
9 should be a cup and some water and all set.
10 DIRECT EXAMINATION
11 BY MS. PAREDES:
12 Q Mr. Strait, would you tell us, please,
13 your current position with Drug Enforcement
14 Administration?
15 JUDGE BITTNER: I think we need his name
16 and spelling.
17 MS. PAREDES: Oh, I'm sorry.
18 BY MS. PAREDES:
19 Q Sir, would you please state your name?
20 A My name is Matthew Strait.
21 Q And can you spell your last name?
22 A S-T-R-A-I-T.
0775
1 Q And what is your current employment?
2 A I work within the Office of Diversion
3 Control, Drug and Chemical Evaluation Section, and
4 I am the Unit Chief for the Quota and U.N.
5 Reporting Unit.
6 Q And that is with the Drug Enforcement
7 Administration?
8 A Yes.
9 Q Okay. And do you have a title?
10 A Yes, Supervisory Physical Scientist.
11 Q And what are your duties in that capacity?
12 A Primarily the functions of the unit are to
13 oversee the administration of the quota system
14 which applies to all manufacturers of Schedule I
15 and Schedule II substances. The unit also takes
16 care of the processing or coordination of the
17 processing of Schedule I researchers.
18 We also handle all of our necessary treaty
19 obligations to provide statistical reports to the
20 International Narcotics Control Board which is a
21 branch of the United Nations.
22 And then some of the other capacities that
0776
1 the unit or the unit chief oversees is assisting
2 some of the other units with their functions, one
3 of which is the coordination of what's known as the
4 303 process, or the process for registering bulk
5 manufacturers of Schedule I and II substances, as
6 well as importers of Schedule I and II substances,
7 and that's overseen by a different unit, and then
8 also a second unit which coordinates the processing
9 of import and export permits and declarations for
10 controlled substances.
11 Q Okay. And in your capacity as the Unit
12 Chief, Quota and U.N. Reporting, do you supervise
13 other personnel?
14 A Yes.
15 Q When did you begin your career with DEA?
16 A I started with DEA August 15, 1999.
17 Q And have you always been in the Quota and
18 U.N. Reporting Unit?
19 A Actually, no. The Quota and U.N.
20 Reporting Unit was created on paper in September of
21 '04, but I've always been in the Drug and Chemical
22 Evaluation Section since I've started.
0777
1 Q Okay. And your highest level of
2 education?
3 A I have a Master's of Science degree.
4 Q Then are you familiar with the DEA
5 procedure when an applicant applies for
6 registration to cultivate a controlled substance?
7 A Yes.
8 Q And you're familiar with that process
9 because your duties with DEA?
10 A Yes.
11 Q Did you have an opportunity to be involved
12 in Dr. Craker's application for registration to
13 cultivate marijuana?
14 A I had been involved in that procedure
15 since October 2002.
16 Q And is that called, what you referred to
17 earlier, the 303 process?
18 A Yes.
19 Q Okay. And how did you get involved in
20 that process?
21 A I believe it all started when DEA received
22 a letter from a law firm known as Covington and
0778
1 Burling regarding the application, and it was
2 tasked to my supervisor at the time, Frank
3 Sapienza, for the coordination of a response. I
4 subsequently was the person involved in
5 coordinating internally within DEA that response.
6 Q Okay. And what did you do to coordinate
7 the response?
8 A It entailed basically consultation within
9 the Office of Diversion Control. Frank was the
10 section chief, and obviously our response would be
11 coordinated by his supervisor or his boss, which is
12 the Deputy Director. At the time that was Terry
13 Woodworth, but then we had--
14 Q Excuse me. Can I interrupt you? Deputy
15 Director of what?
16 A The Office of Diversion Control.
17 Q Okay.
18 A But interoffice coordination is required,
19 and we certainly, in light of the fact that it was
20 from a law firm, we interacted directly with our
21 Office of Chief Counsel.
22 Q Okay. And what did you in particular,
0779
1 what steps did you take, what initial steps did you
2 take?
3 A Actually, initially, I consulted with
4 Frank as to his thoughts on how we should respond,
5 how the agency should respond to this letter. That
6 prompted some, an internal discussion. I don't
7 recall if it was via phone or a sit-down meeting,
8 but it prompted a subsequent discussion with Chief
9 Counsel who I think provided us with the
10 appropriate response that we subsequently ended up
11 going forward with.
12 Q Now, you mentioned a letter from a law
13 firm of Covington and Burling.
14 A Uh-huh.
15 Q Did that contain Dr. Craker's application?
16 A No, it was, it did not contain the
17 application.
18 Q What was the substance of the letter?
19 A The substance of the letter was their law
20 firm's interpretation of the requirements of the
21 international drug control treaties it pertained to
22 the application of Dr. Craker.
0780
1 Q Okay. So let's go back to Dr. Craker's
2 actual physical application, which I believe is
3 Government Exhibit 2 or 3, if the witness can be
4 handed that. It's actually Government Exhibit 1.
5 A Thank you.
6 MS. CARPENTER: I'm sorry. What's the
7 number?
8 MS. PAREDES: One.
9 MS. CARPENTER: Government 1.
10 MS. PAREDES: Government 1.
11 BY MS. PAREDES:
12 Q Mr. Strait, if you could take a look at
13 Government Exhibit 1 and look up when you're
14 completed. Do you recognize this application?
15 A I do.
16 Q Okay. And is this the first time you've
17 seen it?
18 A No.
19 Q Okay. When was the first time that you
20 saw it?
21 A I would say probably at or around October
22 of 2002.
0781
1 Q Okay. And what were the circumstances of
2 you seeing this?
3 A After the response to that first letter
4 that I referred to, we subsequently--I think our
5 office had actually done a little bit of a
6 restructuring, and it was in late 2002 or early
7 2003 where some of the functions that had been in
8 our Registration Section--a different section--we
9 refer to ODR--had been moved.
10 One of the functions that was moved was
11 this 303 process or this registration process.
12 Also, the processing of Schedule I research
13 registrations were also moved out of ODR. We got--
14 our section--the Drug and Chemical Evaluation
15 Section--got the researcher applications which we
16 still do today and it now falls under my unit.
17 And then a different section got the 303
18 process. Our two sections, my ODE, Drug and
19 Chemical Evaluation, and the Domestic Operations
20 Group, coordinated jointly on the processing of
21 this application given what was perceived as a
22 scientific nature of the request.
0782
1 Q Okay. So what did you do--what did you do
2 after you initially were assigned to coordinate the
3 internal response, interoffice response?
4 A Well, actually it was more what I was told
5 to do at the time. Frank Sapienza had taken an
6 active role in the processing of this application.
7 And the first--
8 MS. CARPENTER: Excuse me, Your Honor.
9 Can I just interrupt for a minute? I don't think
10 any of this is covered in the prehearing statement
11 and I was, a little bit of it I was happy to let
12 go, but it seems like we're going to be spending a
13 long time on it--this letter from Covington and
14 Burling. I may have missed something, but I sure
15 didn't see it.
16 JUDGE BITTNER: Okay.
17 MS. PAREDES: May I response?
18 JUDGE BITTNER: Yes.
19 MS. PAREDES: We're not going to go into
20 this letter from Covington and Burling. This is
21 really just background as far as what Mr. Strait's
22 involvement was in going out to see the CMCR
0783
1 researchers.
2 MS. CARPENTER: I thought that's what you
3 were just talking about. I thought he was
4 responding to the letter.
5 JUDGE BITTNER: I think we were now on the
6 application itself.
7 MS. CARPENTER: Oh, not the letter. I'm
8 sorry.
9 MS. PAREDES: Correct.
10 MS. CARPENTER: I misunderstood. I
11 thought he said--is that where we are?
12 MS. PAREDES: Yes, on Government Exhibit
13 1.
14 MS. CARPENTER: Okay.
15 JUDGE BITTNER: Okay. Do we still have an
16 objection pending?
17 MS. CARPENTER: Not if we're not going to
18 back to the letter. That's fine.
19 JUDGE BITTNER: Okay. Then go ahead.
20 BY MS. PAREDES:
21 Q Did I ask you a question? So what was
22 your role next after Mr. Sapienza tasked you with
0784
1 coordinating the response?
2 JUDGE BITTNER: Now wait a minute. Are we
3 on the response to the letter or the response to
4 the application?
5 MS. PAREDES: No, no, no. The response to
6 the 303, in coordinating the 303 application
7 process response.
8 JUDGE BITTNER: Okay.
9 THE WITNESS: I think I can resolve the
10 questions here. In review of the application, it
11 was decided that Frank would send out a letter to
12 the applicant, Dr. Craker, stating that we had some
13 certain concerns with the application. And that we
14 wanted to get more information from him.
15 JUDGE BITTNER: Okay. Well, wait a
16 minute. Let's get to the active voice here. Who
17 decided that that's what you would do?
18 THE WITNESS: It would have been
19 coordinated by Frank. It was signed by, the letter
20 was signed by Frank.
21 JUDGE BITTNER: Okay. But who--I think
22 what you said is it was decided that, and my
0785
1 question is who decided?
2 THE WITNESS: At this point, there wasn't
3 the interoffice coordination. I mean letters had
4 been coming in from in different capacities. The
5 application had been existent. So I can't say that
6 there was interoffice coordination on the whole
7 aspect of the application at that point, but Frank
8 had taken it upon himself to respond directly to
9 the application that was offered by Dr. Craker with
10 a letter dated March 4, 2003, which is what I
11 assisted in preparing.
12 JUDGE BITTNER: Okay. So Mr. Sapienza
13 decided that he would respond?
14 THE WITNESS: Yes.
15 JUDGE BITTNER: Okay.
16 BY MS. PAREDES:
17 Q So you just finished up by saying that you
18 assisted Mr. Sapienza with writing a letter to Dr.
19 Craker?
20 A Yes.
21 Q Okay. And what was the contents of that
22 letter?
0786
1 A The contents of the letter basically said
2 that we had certain concerns that were both legal
3 and international treaty related, and we just asked
4 for him to provide us some additional comments.
5 Q Okay.
6 A There was also a comment made about the
7 fact that we had disagreed with some assertions
8 that there were problems with the quality and
9 quantity and potency of the marijuana provided by
10 the University of Mississippi.
11 Q Now, what did you do next?
12 A Actually we did receive a response back
13 from the University of Massachusetts, but we also
14 ended up having a coordinated meeting--and this is
15 kind of where I think we get to the point of when
16 this application really started being coordinated
17 within the office--in June of 2002.
18 JUDGE BITTNER: 2002?
19 THE WITNESS: June of 2003. Thank you.
20 And that's when we actually started having
21 interoffice coordination on this application to
22 which I would say Frank was wholeheartedly involved
0787
1 in this process.
2 BY MS. PAREDES:
3 Q Okay. I'd like to show the witness
4 Government Exhibit 29. I apologize.
5 A Thank you.
6 Q Mr. Strait, if you'll look over Government
7 Exhibit 29 and look up when you're completed.
8 A Okay.
9 Q Do you recognize this letter?
10 A I do.
11 Q Okay. And what is it?
12 A This is the letter that I was referencing
13 earlier. This is the March 4, 2003 letter that we
14 provided to the applicant.
15 Q Okay. And you had a hand in drafting
16 this?
17 A Absolutely.
18 Q Do you recognize the signature on page
19 two?
20 A Yes.
21 Q Whose signature is that?
22 A That was the Deputy Section Chief which
0788
1 would have been the person underneath Frank at the
2 time. With Frank's retirement, she has now assumed
3 the position of Section Chief for the office, but
4 typically when responses go out, and the Section
5 Chief is not around on that day, they're out for
6 whatever reason, the deputy is put in charge and
7 has full signing authority for the section.
8 Q And that signature is Christine Sannerud?
9 A Yes.
10 JUDGE BITTNER: Can you spell that? I
11 can't read the handwriting.
12 THE WITNESS: It's S-A-N as in Nancy--N as
13 in Nancy--E-R-U-D.
14 JUDGE BITTNER: Okay. Thank you.
15 MS. PAREDES: Your Honor, we ask that this
16 document be admitted into evidence.
17 MS. CARPENTER: No objection, Your Honor.
18 JUDGE BITTNER: Received.
19 [Government's Exhibit No. 29
20 was marked for identification
21 and received in evidence.]
22 BY MS. PAREDES:
0789
1 Q Okay. I apologize. Let's jump to--you
2 said June 2003 was when the interoffice
3 coordination actually began.
4 A Uh-huh.
5 Q And what did you do in June 2003?
6 A Actually, in June 2003, I was still
7 probably more of just assisting Frank. We had a
8 meeting coordinated by Frank amongst the head of
9 the office or I should say the Deputy Director of
10 the Office, which would have been Terry Woodworth,
11 the Section Chief for our section which was Frank,
12 the Section Chief for our Drug Operations group,
13 which at that time was a woman named Betsy Willis,
14 and then also our Office of Chief Counsel, both the
15 regulatory section and the litigation section, CCR
16 and CCD.
17 Q Okay. And then what did you do?
18 A At that point, we acknowledged that there
19 was an application. We had concerns about the
20 application, and we felt that given some of the
21 past problems that our office has actually received
22 from other offices within the agency, we actually
0790
1 felt that we needed to be very careful in how we
2 proceeded with this application.
3 Q Okay. And so how did you decide to
4 proceed with the application?
5 A At that time, Terry Woodworth had given
6 the direction to have representative from ODE and
7 ODO--this would be our section and Betsy Willis'
8 section--
9 JUDGE BITTNER: Okay. What are those?
10 What are the real names?
11 THE WITNESS: Drug and Chemical Evaluation
12 is ODE, and then the Drug Operations Section, which
13 is ODO. So Terry had directed both sections to
14 conduct interviews, first of all, go out to the
15 CMCR, which we had understood were the only place
16 where this marijuana research was being conducted,
17 to go out and interview the federal government.
18 That is HHS, NIDA, FDA. Go talk to other
19 researchers which were conducting research with
20 Schedule I substances like marijuana for
21 potentially drug abuse type studies, to get a firm
22 understanding of some of the comments that were
0791
1 being made by the applicant regarding quality.
2 BY MS. PAREDES:
3 Q And were you involved in conducting these
4 interviews?
5 A Yes, it was suggested that I be the
6 representative from ODE to assist.
7 JUDGE BITTNER: Okay. Now who suggested?
8 THE WITNESS: That would have been Terry.
9 Terry Woodworth would have suggested this and
10 actually it's an important point because Frank
11 actually initially did not want me to participate
12 because he said I had too many other things going
13 on. So I had asked if I could participate and he
14 finally did allow me to be that person.
15 BY MS. PAREDES:
16 Q And what was the extent of your
17 participation initially?
18 A We were jointly, myself and Helen Kaupang,
19 which was the nominee for ODO, we were jointly
20 tasked with going out to interview all of these
21 people who I just mentioned, all of these agencies.
22 The idea was given the technical nature of
0792
1 the application or what it was that the applicant
2 wanted to do, they wanted someone from the office's
3 scientific staff, which was the Drug and Chemical
4 Evaluation Section. So my function was more to
5 assist in kind of understanding what it was the
6 applicant was trying to do and what the status of
7 research in this area was. So that was more or
8 less my function.
9 JUDGE BITTNER: And who is "they"?
10 THE WITNESS: I'm sorry?
11 JUDGE BITTNER: You said "they wanted
12 someone from the science staff." Who is "they"?
13 THE WITNESS: The Office of Diversion
14 Control, Terry Woodworth.
15 JUDGE BITTNER: Okay.
16 THE WITNESS: Yeah. I'll try to get
17 better at that, Your Honor.
18 BY MS. PAREDES:
19 Q So what did you do next in fulfillment of
20 these duties?
21 A In fulfillment of these duties, we started
22 interacting first with the Center for Medicinal
0793
1 Cannabis Research, or CMCR. That was the first
2 group of people that we had wanted to interact with
3 and Frank certainly had contacts with the CMCR, and
4 so we thought that would be the best place to start
5 first with the researchers.
6 Q Okay. And you physically went there?
7 A Yes.
8 Q Okay. And what did you do to prepare
9 before going out there?
10 A I actually developed a questionnaire and
11 this was at the consultation of the Office of Chief
12 Counsel as well as the Office of Diversion Control
13 in this June meeting. It was thought that it would
14 be a good idea to have on paper the respondent's
15 answers as they, as close as to they could have
16 responded to those answers.
17 Q And when you say respondents, you mean the
18 people that you were interviewing?
19 A Yes.
20 Q Okay. So can we hand the witness
21 Government Exhibit 16? Mr. Strait, if you would
22 look this over briefly and look up with you're
0794
1 completed. And for the record, it's 19 pages.
2 Okay. Mr. Strait, do you recognize this?
3 A I do.
4 Q And what is it?
5 A This is one of two questionnaires we
6 developed. In our understanding of how we would
7 proceed, we decided that we would interview not
8 only the CMCR principal investigators themselves,
9 but then also those that led the CMCR, which was
10 the administrative staff, headed by Dr. Igor Grant,
11 and we figured that he had a different perspective
12 on things that he would probably want to share with
13 us, and actually this questionnaire is slightly
14 different than the questionnaire that we
15 administered to the other PIs.
16 JUDGE BITTNER: I'm sorry, Mr. Strait, but
17 who is "we"?
18 THE WITNESS: Well, it was originally
19 supposed to be myself and Helen Kaupang, but in
20 2003, Hurricane Isobel, I believe, disseminated her
21 apartment right before we left. So I ended up
22 going by myself and then was met by two Diversion
0795
1 investigators in our local office out there in San
2 Diego.
3 JUDGE BITTNER: Okay. And those are the
4 Ms. Bagley and Ms. Bartolomeo?
5 THE WITNESS: Yes.
6 JUDGE BITTNER: Okay.
7 BY MS. PAREDES:
8 Q So Mr. Strait, you or your office designed
9 the questionnaire that we're looking at, Government
10 Exhibit 16?
11 A Yes.
12 Q I'd like you to look at Government Exhibit
13 16, and there is typewritten materials as well as
14 handwritten materials; is that correct?
15 A Yes.
16 Q Whose handwriting is this if you know?
17 A Actually there's two sets of handwriting
18 on here. The majority of it is my own, but then
19 there are notations throughout this document that
20 are from a woman at the CMCR whose name is Heather
21 Bentley.
22 Q Okay.
0796
1 A And the other set of handwritten notes are
2 her comments.
3 Q Okay. And those are the only two
4 handwritten comments on Government Exhibit 16?
5 A I believe so, yes.
6 MS. PAREDES: Your Honor, we ask that
7 Government Exhibit 16 be admitted into evidence.
8 JUDGE BITTNER: Could I just ask which
9 comments are whose?
10 THE WITNESS: The one that is messier is
11 mine.
12 JUDGE BITTNER: Okay. I'm not going to
13 make that subjective determination.
14 MS. PAREDES: I think I can ask some
15 questions.
16 JUDGE BITTNER: Yes.
17 BY MS. PAREDES:
18 Q Mr. Strait, on the first page of
19 Government Exhibit 16, where it says date and place
20 of interview.
21 A Yes.
22 Q This says 9/23/03.
0797
1 A Uh-huh.
2 Q Is that your handwriting?
3 A Yes.
4 Q And then the handwriting just below that,
5 two paragraphs below, where it says CMCR overview
6 Dr. Grant. Is that the other woman, Ms. Bentley's
7 handwriting?
8 A Yes.
9 Q And then again at the very bottom of the
10 first page where it says meeting initiated by DEA.
11 Is that handwriting Ms. Bentley's?
12 A Yes.
13 JUDGE BITTNER: And the reference to Ms.
14 Kaupang being unable to attend due to the--unable
15 to attend is hers?
16 THE WITNESS: I believe so. I don't see
17 that in particular.
18 JUDGE BITTNER: Under introductory
19 remarks?
20 THE WITNESS: No, those comments--oh, yes,
21 under my comment Helen Kaupang, Heather actually
22 responded by saying unable to attend due to
0798
1 hurricane. She must have been taking notes during
2 my introductory remarks.
3 JUDGE BITTNER: And then plasma levels is
4 probably her too?
5 THE WITNESS: Yes.
6 JUDGE BITTNER: Got it. Okay. And the
7 Government has offered this exhibit. Ms.
8 Carpenter?
9 MS. CARPENTER: I just had one voir dire
10 question for the witness.
11 JUDGE BITTNER: Uh-huh.
12 VOIR DIRE
13 BY MS. CARPENTER:
14 Q When were these--when were Heather
15 Bentley's comments added? Was it after you had
16 written or at the same time?
17 A No, actually it's in regard to the process
18 that we followed. After we conducted all of our
19 interviews on September 23 and 24, we left the
20 questionnaires for the principal investigators as
21 well as this particular questionnaire with the
22 CMCR, and Heather Bentley coordinated the review
0799
1 and modifications by the principal investigators.
2 And so this would have been provided to us
3 at the same time when the others were responded to
4 us, when we got the package, which was in January
5 of '04.
6 Q So she added these comments after you had
7 already left as a part of modifying?
8 A I can't, I can't answer that specifically.
9 She may have been taking these notes during the
10 interview.
11 Q Were you taking these notes during the
12 interview? I guess that's my question.
13 A Yes, yes.
14 Q Okay. And she would have had access to
15 the same paper at the same time?
16 A No, actually I don't think she did.
17 Q Okay.
18 A I don't think she did.
19 Q So likely she added them after.
20 A So she may have added this afterwards.
21 MS. CARPENTER: That's fine. We have no
22 objection, Your Honor.
0800
1 JUDGE BITTNER: Received.
2 [Government's Exhibit No. 16
3 was marked for identification
4 and received in evidence.]
5 DIRECT EXAMINATION (Continued)
6 BY MS. PAREDES:
7 Q Okay. Mr. Strait, on September 23, 2003
8 is when you physically went to California to
9 interview the CMCR?
10 A Yes.
11 Q Okay. Now why don't you start at the
12 beginning and what did you bring with you? Did you
13 bring this Government Exhibit 16?
14 A I did.
15 Q Okay.
16 A The uncompleted version of it.
17 Q So when you brought it with you, there was
18 only typewritten information?
19 A Yes.
20 Q Okay. Now start at the beginning with who
21 did you meet when you went there?
22 A Well, there were a number of people
0801
1 actually in the conference room that we met with,
2 and as you'll see on the list here on page one, I
3 tried my best to get the spelling right of all of
4 these folks.
5 But the CMCR, those, what I had been
6 considering the administrative staff, and that's
7 not to degrade their qualifications, but their
8 function within the CMCR, we met with Dr. Igor
9 Grant, who actually led the meeting, who was the
10 head of CMCR; Dr. Atkinson; Dr. Mattisson; Heather
11 Bentley; Dr. Thomas Marcotte; Chaundra Newmeyer;
12 and Karen Houpt.
13 These were people that were available in
14 the room. The investigators that were available as
15 well were Dr. Cory-Bloom and Dr. Wallace, and then
16 they had piped in via phone Dr. Israelski and a
17 registered nurse who was representing Dr. Abrams
18 who, of course, is in San Francisco.
19 Q So all of the people that you just
20 mentioned were participating in this meeting on
21 September 23?
22 A Yes.
0802
1 Q Okay. All at the same time or at
2 different times?
3 A Yes, the initial meeting which started in
4 the morning, these people were all available.
5 After we kind of had gone through some of my
6 introductory remarks in front of the group, certain
7 people, the doctors who were not going to be
8 getting the interviews at that present time,
9 actually were free to go on and take care of other
10 very important things that they do.
11 And only those people who were necessary
12 to be involved in the interviews remained and in
13 that case, I should say that Dr. Mattisson and
14 Heather Bentley did stay for all of the interviews
15 that were conducted while in San Diego. So they
16 were present for all of these interviews that we
17 conducted with the principal investigators.
18 Q Okay. Now, do you know if CMCR was aware
19 that you were coming?
20 A Oh, yes.
21 Q Okay. Now, what was the substance of your
22 introductory remarks?
0803
1 A I noted them here. This is more or less
2 my crib notes. I just kind of like to take notes
3 before I get ready to do anything. And basically
4 from what I wrote down here, I just sent out thanks
5 to Dr. Mattisson who was really my primary point of
6 contact for coordinating the meeting. I had been
7 stating to them throughout this whole process that
8 Ms. Kaupang would be with me, and that we would
9 have two people from the field, who the CMCR was
10 certainly they knew very well.
11 And then I explained a little bit about
12 why we were here and the questionnaires that we
13 there to administer.
14 Q Now let me interrupt you there. I'm
15 sorry. What did you tell them about why you were
16 there?
17 A I actually told them that we were there
18 because we had received an application from a
19 person who wished to cultivate marijuana. I
20 believe that I had also mentioned, and if I hadn't,
21 in preparing for the meeting, it's likely someone
22 had DEA had mentioned that it was the University of
0804
1 Massachusetts. And that certain comments about
2 quality and potency were made and we were coming
3 there to actually just learn about what the
4 principal investigators' thoughts were on these
5 issues.
6 Q Okay. What else did you tell them in your
7 introductory remarks?
8 A I basically informed them that the
9 questionnaire was there to deal with three
10 particular issues--adequacy of supply, quality and
11 potency--and that we were going to administer the
12 same questionnaire to all of the principal
13 investigators who were there. I then gave them
14 instructions that what we were looking for at the
15 time was they would give their comments to us, we
16 would give the questionnaire back to them, and
17 while it was fresh in their mind, they could ahead
18 and make modifications or changes and then initial
19 each page to support that they agreed with the
20 comments that were made, and then they would return
21 it to us, but as I mentioned, in practicality, that
22 didn't actually work out that way.
0805
1 We ended up giving them the questionnaires
2 and they had them for about two-and-a-half months
3 before they actually returned them to us.
4 Q Okay. Now you mentioned earlier that you
5 were taking notes at the time of your interviews?
6 A Yes.
7 Q On this questionnaire?
8 A Yes.
9 Q So do you know if the researchers had
10 access to your handwritten notes?
11 A Yes.
12 Q Okay. Now, I notice that on Government
13 Exhibit 16, they don't appear to be any initials.
14 A Right. We, I'm sorry--
15 Q Can you explain that?
16 A We weren't necessarily interviewing those
17 people who weren't actively doing research. The
18 people who we were most interested in obtaining
19 this information from were those people who, one,
20 were registered with DEA as Schedule I researchers;
21 two, actually filled out the 222s and obtained and
22 viewed the material.
0806
1 We felt that they were the people who had
2 the most information that they would provide. So
3 this questionnaire, we did not seek or try to seek
4 the confirmation from Dr. Grant or Dr. Mattisson or
5 Heather Bentley, for that matter, of their
6 comments.
7 Q But was it Heather Bentley then that
8 mailed you back this Government Exhibit 16?
9 A Yes.
10 Q Now, I don't know if it's on the original,
11 but on my copy, on page one of Government Exhibit
12 16, there seems to be some handwriting at the very
13 bottom that's cut off.
14 A Uh-huh.
15 Q Do you know what--is that your
16 handwriting?
17 A No, it's not.
18 Q Do you know--that's Ms. Bentley's
19 handwriting then?
20 A Yes.
21 Q Do you know what it says or what she meant
22 to say?
0807
1 A I don't know if it's cut off on this
2 version. Maybe it is. It says: Meetings initiated
3 by DEA. Purpose of the meeting: for CMCR to
4 provide information on experience with quality,
5 potency, and availability of study drug received
6 from NIDA in order to assist DEA in evaluating the
7 6/25/03 application from the University of
8 Massachusetts to bulk manufacture marijuana and THC
9 for distribution to approved researchers.
10 Q Okay. Now, with regard to Government
11 Exhibit 16, how long did this meeting last?
12 A I'd say generally, I don't recall
13 specifically, but I would say at least two hours.
14 Q Okay. So after the initial, your
15 introductory remarks, what happened next?
16 A We actually received a presentation from
17 Dr. Grant before we initiated this questionnaire.
18 So I provided my introductory remarks. Dr. Grant
19 then provided an overview of the CMCR which we were
20 certainly very interested in hearing, and at that
21 point it was after that that we initiated this
22 questionnaire.
0808
1 Q Okay. Now, I'm sorry, just to backtrack
2 for one second. When you were explaining why you
3 were conducting these interviews and you explained
4 to the audience that it was the--you had received
5 an application and you were looking at the quality,
6 potency, and quantity of the marijuana, did you go
7 into any specifics as to what about the quality,
8 potency, or quantity, of what the complaints were?
9 A I don't think we got into any detail at
10 that point about what specific issues we were
11 looking at at that point, no.
12 Q But did you mention what complaints you
13 had received about the marijuana?
14 A I don't believe so.
15 Q Okay. Well, what was briefly the
16 substance of Dr. Grant's presentation?
17 A Background on the CMCR, how they came to
18 be, their three-stage research mission, which they
19 felt consistent with the '97 NIH study and the '99
20 IOM report.
21 Q And did he go into any detail about what
22 the three-stage research mission was?
0809
1 A Yes.
2 Q Can you explain what he said?
3 A Yeah, basically according to Dr. Grant's
4 stage one was where they were at in September '03
5 and specifically that was the use of what was
6 available, which was smoked marijuana, to look at
7 its effect in certain patient populations that were
8 approved by their scientific review boards and
9 California's review boards.
10 Stage two involved the identification of
11 different or novel drug delivery systems,
12 inhalants, sprays, vaporizer devices I think were
13 mentioned at that point. Anyway, the point being,
14 as he had said in a conference, beyond the smoke,
15 you know, what types of research can we do that's
16 not involving smoke.
17 And then stage three was really meant to
18 look at certain cannabinoids or cannabinoids that
19 are slightly altered to have a desired impact. So
20 it was really getting down at some of the
21 constituents, synthetic or semi-synthetic
22 cannabinoids or naturally derived cannabinoids that
0810
1 could be used and potentially tested in certain
2 populations of people.
3 Q Now when you say "cannabinoids," what are
4 you referring to?
5 A Cannabinoids, it's my understanding that
6 these are the active or not necessarily active
7 constituents in the marijuana plant. Oftentimes,
8 and we see this with opiates, cannabinoids can be
9 slightly altered or opiates can be slightly
10 altered, and we say synthetically altered, to
11 produce other substances which may have more potent
12 effects or less potent effects on the body.
13 Q Okay. And did he say at which stage the
14 CMCR was at?
15 A Yes, actually I think at the time it was
16 really stage one. They were looking at smoked
17 marijuana protocols.
18 Q Okay. Did Dr. Grant say anything else in
19 his introductory remarks?
20 A I would say really just more background
21 information.
22 Q Okay. And then did you at that point move
0811
1 on to the actual questionnaire?
2 A Yes. And I can't recall if certain people
3 left the room or not. I want to say that, you
4 know, I felt as if we were holding these people up
5 for a long time, so I think we gave those people
6 the opportunity to leave that had other important
7 things to go on. So, but we did immediately
8 following administer the questionnaire.
9 Q Okay. And who was the primary
10 representative, I guess, of CMCR?
11 A Dr. Grant.
12 Q Okay. And then pages two through 19 of
13 Government Exhibit 16, was that the process or
14 procedure that you went through?
15 A Yes, we went question by question through
16 the questionnaire.
17 Q Okay. Now, did Dr. Grant have any
18 specific comments regarding the, or did CMCR, which
19 Dr. Grant is the representative, have any specific
20 comments as to the quality of the marijuana from
21 NIDA, from the University of Mississippi?
22 A The questions regarding quality started on
0812
1 page 11. Based on those questions, there was some
2 mention of some things that we might learn more
3 about from some of the other principal
4 investigators, and if I could summarize to a
5 degree, there was some variation in the potency of
6 the product that was provided to researchers.
7 There was an occasional mention of certain
8 harshness which I later learned meant that it
9 produces cough in certain subjects or some
10 subjects.
11 We learned that he has looked at them and
12 has found no visual difference between placebo and
13 non-placebos. We learned that he had gone to Dr.
14 ElSohly's farm, if you will, to view how material
15 was manufactured and shipped and processed, and he
16 was satisfied with their ability to obtain this
17 visually consistent product.
18 And we also learned that in his opinion
19 there was nothing about the quality of these
20 products that affected their research.
21 Q Okay. May I have the witness see
22 Government's Exhibit 17.
0813
1 JUDGE BITTNER: Could I--there's a few
2 things in 16 I couldn't read first.
3 THE WITNESS: Sure.
4 JUDGE BITTNER: On page eight, at the top
5 the second sort of bullet point there, moving to
6 non-smoked products, and then there's an arrow and
7 sublingual spray. I got that. And then something
8 underneath that?
9 THE WITNESS: There is a company. It's
10 the company that actually manufactures the drug
11 product Marinol. I think they're actually the NDA
12 holder. Solvay is the name of the company, and
13 they're actually working on a sublingual spray.
14 JUDGE BITTNER: Okay. So it's Solvay. I
15 couldn't see if that was Solvay or solving product
16 availability--question mark.
17 THE WITNESS: It should be capital "S" for
18 Solvay.
19 JUDGE BITTNER: Okay. Okay.
20 THE WITNESS: And the question mark after
21 it represents an issue that was brought up when
22 they talk about availability in general.
0814
1 Researchers have had a need to have a basis of
2 comparison for their smoked products.
3 And a lot of companies that market
4 pharmaceutical products are concerned just in
5 general with doing what they refer to as head-to-head
6 studies. And in this case, there was an issue
7 of availability for a sublingual spray if, in fact,
8 the company who they would have to purchase it from
9 would actually have to buy off on the idea that it
10 was going to be compared against smoked marijuana
11 or marijuana available in a smoked form.
12 And companies just as a rule of thumb are
13 very hesitant to want to participate in those types
14 of studies. So the comment made by Dr. Grant is
15 that whereas you may want to compare different
16 types of products to other potentially marketed
17 products--this sublingual spray has not been
18 marketed by the firm--that a lot of these companies
19 may be hesitant to do so, which is a barrier for
20 research for some of them.
21 JUDGE BITTNER: Okay. In the next box, on
22 that same page, can you just--I wasn't sure where
0815
1 the arrows went. So could you read it, the whole
2 box? It's not that long.
3 THE WITNESS: Yeah. I actually spent some
4 time looking at this myself. Basically one of the
5 comments that Dr. Grant had made to me is that the
6 CMCR is dependent on smoked products, first and
7 foremost, because of the limitations in non-smoked
8 alternatives, and--
9 JUDGE BITTNER: Okay. Meaning that--I
10 mean what I was reading is that there are very non-smoked
11 alternatives available, and I didn't--
12 THE WITNESS: I think that is where the
13 insertion is supposed to be.
14 JUDGE BITTNER: Okay. Was the "few"
15 supposed to be in there or not? Because I see it's
16 crossed off.
17 THE WITNESS: It is crossed off on here.
18 I mean at present there is one non-smoked
19 alternative available, and that is Marinol.
20 JUDGE BITTNER: Okay.
21 THE WITNESS: So maybe it was incorrect to
22 say a few because there really weren't a few.
0816
1 There's only one.
2 JUDGE BITTNER: Oh, okay.
3 THE WITNESS: But that was an insertion
4 made by Ms. Bentley.
5 JUDGE BITTNER: Okay. And I think on the
6 next page--
7 THE WITNESS: Uh-huh.
8 JUDGE BITTNER: First box, GW--and this is
9 the British firm about which we heard yesterday?
10 THE WITNESS: Yes.
11 JUDGE BITTNER: Okay--has a very
12 sophisticated procedure--
13 THE WITNESS: Yes.
14 JUDGE BITTNER: --of genetic engineering?
15 THE WITNESS: Yes.
16 JUDGE BITTNER: And can adequately--they
17 appear to be able to predict the concentrations
18 better?
19 THE WITNESS: Yes. And actually that
20 statement Heather corrected down at the bottom by
21 preceding that sentence. She said below, the one
22 area we might look to see more reliability on is
0817
1 the strength of the medical marijuana cigarettes.
2 We know this is difficult with plant material, but
3 we were told that--
4 JUDGE BITTNER: GW has a very
5 sophisticated--okay.
6 THE WITNESS: Yes. Then it proceeds by GW
7 has a sophisticated procedure.
8 JUDGE BITTNER: Okay. I think--
9 MS. CARPENTER: I'm sorry, Your Honor. I
10 don't see "has a sophisticated procedure" on there.
11 Am I missing something? Or is it GW can guarantee
12 the--
13 JUDGE BITTNER: On--
14 MS. CARPENTER: Yeah, maybe the witness
15 could--
16 JUDGE BITTNER: Yes, okay. In the top
17 box, the one with the writing in it.
18 MS. CARPENTER: Right.
19 JUDGE BITTNER: And the question: Do you
20 feel that any problems you experience could be
21 remedied? Okay. The next line: GW has a very
22 sophisticated procedure.
0818
1 MS. CARPENTER: Right. And the arrow,
2 though, doesn't go to that line. It goes to the
3 "but GW"--
4 JUDGE BITTNER: But the next bullet point,
5 according to Mr. Strait, was after do you feel--the
6 answer to the question is the one area we might
7 like to see--
8 MS. CARPENTER: I think--right.
9 JUDGE BITTNER: --more reliability on is
10 the strength of the medical marijuana cigarettes.
11 We know this is difficult with plant material but
12 we were told that--
13 MS. CARPENTER: And it looks like it goes
14 to GW can guarantee--is that with certain, more
15 certainty? No?
16 JUDGE BITTNER: Yeah, I guess the question
17 is what comes after that?
18 THE WITNESS: It appears that she has put
19 the arrow to "told that GW can guarantee with more
20 certainty. If that were possible, it would lessen
21 the degree of uncertainty."
22 JUDGE BITTNER: Now I'm lost.
0819
1 MS. CARPENTER: Yeah, perhaps he could
2 just read it from the beginning with the insertions
3 in the appropriate place?
4 JUDGE BITTNER: Right. I'm missing the
5 "guarantee" somewhere.
6 THE WITNESS: Okay.
7 JUDGE BITTNER: Yeah. Oh, I see. Were
8 told that GW can guarantee with more certainty. If
9 it were possible, it would lessen the degree of
10 uncertainty. GW has a very sophisticated.
11 Yeah. If you would read it the way it's
12 supposed to be, Mr. Strait.
13 THE WITNESS: Well, I'll read it to the
14 extent that I believe that Ms. Bentley meant it.
15 JUDGE BITTNER: Okay.
16 THE WITNESS: I would say that do you feel
17 any problems you've experienced could be remedied
18 by the addition of a second supplier? I would say
19 that the response, as corrected by Ms. Bentley,
20 would be: The one area we might like to see more
21 reliability on is the strength of the medical
22 marijuana cigarettes. We know this is difficult
0820
1 with plant material, but we were told that GW can
2 guarantee with more certainty.
3 And then there is a question as to where
4 it goes from there, but I would say that it
5 probably proceeds by saying: GW has a very
6 sophisticated procedure of genetic engineering.
7 They appear to be able to predict the
8 concentrations. If that were possible, it would
9 lessen the degree of uncertainty.
10 JUDGE BITTNER: Okay. But then what about
11 they don't know if UMiss does that? That's not
12 stricken out. That's in there someplace.
13 THE WITNESS: Yes. I'm sorry. I must
14 have jumped to the wrong section.
15 JUDGE BITTNER: Okay. I think we'll leave
16 it there. I think we've got the basic idea.
17 BY MS. PAREDES:
18 Q Mr. Strait, if you can turn to page six of
19 Government Exhibit 16. Did Dr. Grant point out
20 that they had any availability or adequacy issues
21 with research marijuana?
22 A No.
0821
1 Q Okay. Now, on page eight of this exhibit,
2 the second box. It would be question 18 really.
3 A Uh-huh.
4 Q Can you explain what the substance of this
5 box is? And the reason--
6 MS. CARPENTER: Your Honor, I think we--
7 BY MS. PAREDES:
8 Q Well, in number 18, the answer is no; is
9 that accurate?
10 A Yes.
11 Q But then next it says if yes, please
12 explain, and then there's an explanation.
13 MS. CARPENTER: Your Honor, may I object
14 just based on--yesterday there was a lot of
15 objection to summarizing documents. I think--
16 JUDGE BITTNER: I think it would be better
17 to just read it because it says whatever it says.
18 The question is what it says, not the witness'
19 interpretation of what it says.
20 MS. PAREDES: Okay.
21 BY MS. PAREDES:
22 Q Do you know why--did you write in number
0822
1 18, did you write in no?
2 A I did. And that would have been the
3 response to the question that we asked, but we also
4 gave Dr. Grant the opportunity to provide any
5 comments and that would have been where I would
6 have written them.
7 Q Okay. Okay. On page 12 of this exhibit,
8 question 25, you wrote in that response?
9 A Yes.
10 Q Okay. Did you have a discussion with Dr.
11 Grant about that response, more than what you've
12 written?
13 A Actually the response to the question is
14 no. And there was some follow-up on his part. I
15 don't know if it was proactively asked on my part,
16 but--
17 Q Okay. And what did he say?
18 A He basically informed me that marijuana
19 provided by the University of Mississippi is
20 guaranteed to be a particular potency, but it is
21 guaranteed within a range, and there is some
22 variation to the extent that it is within this
0823
1 range of potencies that is guaranteed by the
2 University of Mississippi through analysis and
3 subsequent analysis.
4 Q Okay. And did Dr. Grant express any
5 satisfaction or dissatisfaction with that range or
6 with that arrangement with the University of
7 Mississippi?
8 A I don't think that anyone complained
9 specifically that this range was a problem. It's
10 just the nature of the research, and it's the
11 nature of plant material. They guarantee that it
12 will be at a potency, and that it falls within that
13 range and over time that material can have a
14 tendency to degrade so they have to give it within
15 a range.
16 Q Okay. Question number 27, is that your
17 handwriting in the box?
18 A Yes.
19 Q And who are you referring to when you make
20 this statement, "did go to UMiss"--
21 A This would have been Dr. Grant.
22 Q So this is Dr. Grant is telling you that
0824
1 he did go to University of Mississippi?
2 A Yes.
3 Q Okay. Okay. The next page, page 13. Is
4 that your handwriting in the second box?
5 A Yes, with exception to the word
6 "occasionally" which was added.
7 Q And do you know who added it?
8 A It would have been Ms. Bentley.
9 Q Okay. Now, did you have a conversation
10 with Dr. Grant then about this question 29,
11 freshness of the marijuana?
12 A I actually did have question about what
13 the term "harsh" meant, and so the second line
14 which says "produces cough" would have been my
15 explanation that I received from Dr. Grant.
16 Q Okay. What did Dr. Grant tell you when
17 you asked him what does "harsh" mean?
18 A Yeah, I had not heard this. I would
19 subsequently hear it from Dr. Abrams when I
20 interviewed him over the phone as well. But at
21 first I did not know what the term meant, so I
22 asked him to describe what that meant and he said
0825
1 that it makes the patient cough. I would learn
2 later that it creates a kind of feeling in the back
3 of the throat that makes you cough.
4 Q Okay. Did he say anything else with
5 regard to what that meant?
6 A No.
7 Q Okay. On page 16--I'm not sure if this is
8 on the original, but on the left hand side of the
9 page under question 35--
10 A Uh-huh.
11 Q --it's cut off.
12 A Yes.
13 Q Some of the handwriting. Is that your
14 handwriting?
15 A Yes.
16 Q Can you, the text that's outside the box,
17 can you read what that should say?
18 A Yeah. That's, it's supposed to read they
19 arrived--that's an ampersand--at eight percent
20 based on discussions with NIDA. NIDA seemed--inserting--
21 NIDA seemed amenable and it seemed
22 appropriate at the time. That's the gist of the
0826
1 comment.
2 Q Okay.
3 A This would have come as a result of me
4 asking in follow-up to his response of, yes, it
5 would be clinically important to evaluate the
6 efficacy of higher potency cigarettes. When he
7 said yes, I would have had a tendency to ask a
8 follow-up question. This question or this response
9 was likely as a result of me asking how you arrived
10 at this highest potency that he had told me in a
11 previous page is what they had come up with.
12 Q Okay. Okay. I'd like to point you now
13 to--do you have Government Exhibit 17?
14 A No, I don't.
15 Q Can you look that over please and look up
16 when you're finished? Do you recognize Government
17 Exhibit 17?
18 A I do.
19 Q What is it?
20 A This is a questionnaire I completed with
21 Dr. Ellis which was over the telephone on the same
22 day that we conducted the CMCR administrative
0827
1 interview.
2 Q Okay. Now, the typewritten portion of
3 Government Exhibit 17 is different from the
4 typewritten portions of Government Exhibit 16; is
5 that correct?
6 A Yes.
7 Q And why is it different?
8 A Well, this goes back to our objective
9 initially from the get-go, and that was that we
10 wanted to meet with the principal investigators and
11 know of their feelings about quality, quantity and
12 potency. The previous questionnaire had dealt with
13 kind of broader picture issues that we felt that
14 the CMCR administrative folks would probably want
15 to address.
16 This was a little bit shorter in that it
17 dealt with just the three central issues that were
18 brought up in Dr. Craker's application.
19 Q Okay. I notice also that, well, did you
20 create this application?
21 A I did.
22 Q Or questionnaire?
0828
1 A Yes.
2 Q Under the typewritten introductory
3 remarks--
4 A Uh-huh.
5 Q Did you write that also?
6 A I did. I wrote this myself.
7 Q Okay. And did you present these to Dr.
8 Ellis verbally or just in writing?
9 A Verbally, and then he, upon receipt of the
10 completed questionnaire that I filled out on his
11 behalf, he would have actually seen these comments.
12 Q Okay. So did you read this, these
13 introductory remarks to him verbatim or--
14 A They were read verbatim, and the idea is
15 that we wanted to make sure we were consistent
16 across all the principal investigators we spoke to.
17 We had actually received a letter in June '03,
18 which was three months prior to us going out to
19 CMCR, from the Multidisciplinary Association for
20 Psychedelic Studies, and we had also received
21 follow-up from Dr. Craker, and we had not ever
22 heard this before, but we were trying to remain
0829
1 attentive to concerns that were brought up in this
2 letter, which the comments in the letter basically
3 stated that they could appreciate--they certainly
4 should be able--DEA should be able to understand or
5 appreciate why principal investigators or marijuana
6 researchers would be fearful of telling DEA about
7 their dissatisfaction with NIDA-grown marijuana.
8 So we tried to remain attentive to that
9 issue and tried to dispel a myth that we, in fact,
10 would not be using this for any reason other than
11 just to help us do some of our internal processing
12 of the application.
13 Q Okay. Now with regard to Dr. Ellis, did
14 you notify him of the reason that you were
15 conducting the interview?
16 A Yes.
17 Q And did you specifically mention the
18 University of Massachusetts or Dr. Craker?
19 A I don't recall. I think once we initiated
20 these interviews, if they weren't available during
21 the introductory remarks, I can't recall
22 specifically about what Government Exhibit 16 said
0830
1 as to whether or not Dr. Ellis was available via
2 phone during the introductory remarks, but we
3 probably did not make those comments during the
4 time when we administered the individual
5 questionnaires.
6 MS. PAREDES: Okay.
7 JUDGE BITTNER: I'm sorry. What comments?
8 THE WITNESS: About the application that
9 we had received from the University of
10 Massachusetts. I tried to stick to these
11 introductory remarks which were handwritten. I'm
12 sorry--which were typewritten. And that would have
13 been my proceeding before I went ahead and started
14 with question one.
15 BY MS. PAREDES:
16 Q Okay. So specifically you didn't tell Dr.
17 Ellis that it was University of Massachusetts or
18 Dr. Craker, but in general did you tell him that
19 another manufacturer had applied for registration?
20 A No, I don't--I don't believe.
21 Q Okay.
22 A I think really all I would have said is
0831
1 that we were assessing the availability of the
2 current source of supply which I think is somewhere
3 paraphrased in my introductory remarks.
4 Q Okay. Now with regard to Government
5 Exhibit 17 under Attendees and Participants, Dr.
6 Ellis was on the telephone, but other people were
7 in the room with you?
8 A Yes.
9 Q And these are the people, CMCR and DEA
10 people, that were in the room with you?
11 A Yes.
12 Q Now, how long was your telephone interview
13 of Dr. Ellis?
14 A I'd say based on the responses, it was
15 fairly short. I don't recall specifically, but I'd
16 say probably no longer than about 20 minutes.
17 Q Okay. And how did you--on the bottom
18 right hand corner, do you recognize this?
19 A Yes.
20 Q And what is that?
21 A That would have been Dr. Ellis'
22 acknowledgement that he has reviewed and accepted
0832
1 the comments that we had handwritten on his behalf
2 based on his verbal responses.
3 Q And do you know how this Government
4 Exhibit 17 was transmitted to Dr. Ellis?
5 A Yes, it was given to Heather Bentley as
6 well as all of the questionnaires upon their
7 completion, and Heather worked and coordinated with
8 the PIs to get their reviews and signatures on
9 these documents.
10 Q Okay. And so then with regard to all of
11 these questionnaires, did you receive them all at
12 the same time from Ms. Bentley?
13 A Yes.
14 Q Okay. Okay. And did you make your
15 handwritten notes contemporaneously with your
16 telephone conversation?
17 A I did.
18 Q And have you noted, do you notice whether
19 Dr. Ellis wrote in anything on the questionnaire?
20 A I think he made one comment. He made a
21 comment on page nine. I'd say he just made a
22 comment on page nine.
0833
1 Q And is that on the right hand side that
2 starts "correction"?
3 A Yes.
4 Q Okay. If you turn to page 12--
5 A Uh-huh.
6 Q --at the very bottom, points to discuss
7 after the interview.
8 A Yes.
9 Q Is that your handwriting?
10 A That is my handwriting.
11 Q And are these points that you discussed
12 after the interview?
13 A Yeah, this was just kind of my standard
14 comments that I wanted to make sure that I gave to
15 each of the participants. And the bottom line is
16 we wanted to thank them for taking their valuable
17 time, but then also felt that we might need to
18 follow up with them at some point, so asked if we
19 could, and then subsequently how they preferred to
20 be notified if we needed to ask follow up.
21 Q Okay. And then point number three, your
22 phone number?
0834
1 A Yes.
2 Q Did you give him your phone number?
3 A Yes.
4 Q And what was the purpose of that?
5 A I informed him that if he had any
6 questions about this or if he had any follow-up
7 things that he wanted to address with me, I would
8 certainly be more than willing to discuss anything
9 at his convenience.
10 Q Okay. And to date, has Dr. Ellis
11 contacted you?
12 A No.
13 MS. PAREDES: Your Honor, we'd move that
14 Government Exhibit 17 be admitted into evidence.
15 JUDGE BITTNER: Ms. Carpenter?
16 MS. CARPENTER: Let me check one thing,
17 Your Honor. No, that's different. We have no
18 objection.
19 JUDGE BITTNER: On page three, Mr. Strait.
20 THE WITNESS: Yes.
21 JUDGE BITTNER: Second box. At present we
22 are considering the use of what's that next thing?
0835
1 THE WITNESS: It's--
2 JUDGE BITTNER: Well, what is written
3 there?
4 THE WITNESS: It's CBME.
5 JUDGE BITTNER: Okay.
6 THE WITNESS: But what it is meant to be
7 is the marijuana extract that is in the product
8 which has been mentioned by Dr. Doblin, Sativex,
9 which has now been approved for use in Canada.
10 JUDGE BITTNER: And what does CBME stand
11 for?
12 THE WITNESS: I don't know what CB stands
13 for, but I know that the ME is marijuana extract.
14 JUDGE BITTNER: Okay. And that's from GW
15 Pharmaceuticals. And then protocol is part of a
16 spring 2003 call.
17 THE WITNESS: Yes.
18 JUDGE BITTNER: Do you know what that
19 references?
20 THE WITNESS: The way the CMCR functions
21 is that they have a spring call or a call for
22 proposals. I don't recall how many calls for
0836
1 proposals they actually had, but at the time of
2 this interview, a protocol submitted by Dr. Ellis
3 involving GW marijuana extract was part of the
4 latest call for proposals, and I don't know the
5 status as to whether or not the CMCR went ahead and
6 provided funding for that protocol or not. But
7 that was the comment that was made.
8 JUDGE BITTNER: Okay. With that,
9 Government 17 is received.
10 [Government's Exhibit No. 17
11 was marked for identification
12 and received in evidence.]
13 BY MS. PAREDES:
14 Q If the witness can be shown Government
15 Exhibit 18.
16 A Thank you.
17 Q Mr. Strait, if you can look over
18 Government Exhibit 18 and look up when you finish.
19 Do you recognize Government Exhibit 18?
20 A I do.
21 Q What is it?
22 A This is the questionnaire that we
0837
1 completed with Dr. Cory-Bloom.
2 Q Okay. And is this in substantial respects
3 the same as Government Exhibit 17?
4 A It is equivalent, yes.
5 Q Now when was the date of this interview?
6 A The date of this interview was on
7 September 23, 2003.
8 Q Was this in person or--
9 A This was in person.
10 Q Okay. And the participants are written
11 there?
12 A Yes.
13 Q Now procedurally, did you follow the same
14 procedure that you did on this interview as you did
15 with Government Exhibit 17?
16 A I did.
17 Q Okay. On the bottom right hand corner on
18 each page, do you recognize those initials?
19 A I don't recognize the initials, but I
20 assume them to be Dr. Cory-Bloom.
21 Q Okay. And did you receive this directly
22 from Ms. Bentley?
0838
1 A Yes, I did.
2 Q Okay. Now when you looked over it, did
3 you notice if there were any other handwriting
4 except for yours?
5 A Actually that's one of the things I was
6 just looking at, and I did not notice any changes
7 to the comments that I provided.
8 Q Okay. Now, in this interview, this
9 personal interview, did the other CMCR employees
10 or, did they have any role in the interview in
11 terms of participating or speaking?
12 A No, this was geared specifically for Dr.
13 Cory-Bloom.
14 Q Okay. So the other three participants
15 were just physically there?
16 A Yes.
17 Q Okay. With regard to page six, question
18 ten, you wrote--is that your handwriting?
19 A Uh-huh.
20 Q Says cannot answer.
21 A Yeah.
22 Q Do you know why?
0839
1 A She was the blinded investigator, which
2 has been described, I think.
3 Q And what does that mean to you when you
4 say blinded investigator?
5 A It means that as part of her scientific
6 protocol, she is not allowed to be aware of the
7 different products that her patients are consuming.
8 Q Okay. Okay. With regard to page ten,
9 question 19.
10 A Uh-huh.
11 Q The handwriting after question 19, is that
12 yours?
13 A Yes, it is.
14 Q Okay. It looks different. I'd like to
15 discuss page 12. Is that your handwriting at the
16 very top?
17 A Yes.
18 Q Okay. I notice that page 12 says
19 additional questions and comments. What happens or
20 what's the point of this page 12?
21 A Yeah, actually what I had kind of learned
22 up-front in the interviews is that Dr. Grant had
0840
1 made some mention of the fact that recruiting has
2 been a problem across the board. So I decided as
3 just an additional thing to make sure I asked
4 across the board was to just ask each PI how
5 recruiting was going.
6 Q And when you say PI, what are you
7 referring to?
8 A Principal investigator.
9 Q Okay. And so did you ask Dr. Cory-Bloom?
10 A Yes, I asked her specifically how
11 recruiting has been going or has it been a problem.
12 Q Okay. The third line, the first two
13 letters.
14 A Yes.
15 Q What is that?
16 A She said that marijuana which is--
17 Q Okay.
18 A That's MJ there--is difficult to recruit
19 for. She also stated that people are not smoking,
20 presumably marijuana, to the degree that they used
21 to smoke, and that for her study in particular,
22 there were a lot of exclusion criteria that went
0841
1 into accepting patients, enrolling patients into
2 her study, and that that had things difficult as
3 well.
4 Q Okay. Now, in the right hand corner, top
5 right hand corner of the box.
6 A Uh-huh.
7 Q There's a letter, looks like N equals 30?
8 A Uh-huh.
9 Q And then 10 of 130 phone calls.
10 A Yeah.
11 Q Can you explain what that means?
12 A The N of 30 is the number of patients that
13 she is recruiting for that study. That's how many
14 she has to have enroll and complete the study as
15 part of her approved protocol. And she had said to
16 me that out of 130 phone calls, only ten at the
17 time of the interview were actually interested in
18 participating in her study.
19 Q Okay.
20 A She also made some mention to this on page
21 three.
22 JUDGE BITTNER: So I'm confused. That
0842
1 sounds like she hadn't gotten the study going yet.
2 THE WITNESS: It means that she was
3 partially through her study. She had called 130
4 patients, ten of which were enrolled, and I don't
5 know at the time what their degree of whether or
6 not they had completed the protocol or whether they
7 were just actively enrolled.
8 But she was ten patients of a total of 30
9 patients deep into the study. So she needed, in
10 order to complete her study, she would have needed
11 30 patients, and as of that day, she had
12 unsuccessfully been able to get 120 out of 130
13 patients to agree to enroll in her study for the
14 various reasons mentioned.
15 JUDGE BITTNER: Okay.
16 THE WITNESS: Does that make any more
17 sense?
18 JUDGE BITTNER: So one thing we don't know
19 on these is how many people over how long and how
20 much they took?
21 THE WITNESS: Right. Yeah, that would
22 have been all stipulated in the protocol.
0843
1 JUDGE BITTNER: Okay.
2 MS. PAREDES: Okay.
3 BY MS. PAREDES:
4 Q Then Mr. Strait, also on the bottom, you
5 wrote--is that your handwriting?
6 A Yes.
7 Q Your wrote points to discuss after the
8 interview. Did you discuss these three points?
9 A Yes, I did.
10 Q Okay. And has Dr. Cory-Bloom contacted
11 you to date?
12 A No, she has not.
13 MS. PAREDES: Your Honor, we move that
14 Government Exhibit 18 be moved into evidence.
15 MS. CARPENTER: No objection, Your Honor.
16 JUDGE BITTNER: Received.
17 [Government's Exhibit No. 18
18 was marked for identification
19 and received in evidence.]
20 BY MS. PAREDES:
21 Q I would ask that the witness be handed
22 Government Exhibit 19.
0844
1 A Thank you.
2 Q Mr. Strait, if you could look this over
3 and look up at me when you finish. Mr. Strait, do
4 you recognize this document?
5 A I do.
6 Q And what is it?
7 A This is the questionnaire that I completed
8 via phone with Dr. Israelski.
9 Q Okay. And is this questionnaire the same
10 as the other questionnaires that you've given to
11 the principal investigators?
12 A Yes. With the exception, and I should
13 have mentioned this with the previous one, the
14 third, the third underlined portion on page one
15 says "protocol," that was just my notation, a note
16 to myself as to what protocol or protocols the
17 principal investigator has approved with the DEA.
18 So that's the only part that changes in the
19 questionnaires.
20 Q Okay. Now, you said this is your
21 telephone interview of Dr. Israelski?
22 A Yes.
0845
1 Q Okay. Now, as far as the attendees and
2 participants from CMCR, were these people
3 physically in the room with you when you did this
4 interview?
5 A Yes.
6 Q And did they participate in any way in
7 terms of talking or contributing to the
8 conversation?
9 A No.
10 Q And did you follow the same procedure with
11 regard to this interview as you did with the other
12 two?
13 A I did.
14 Q Okay. And was this returned to you from
15 Ms. Bentley then?
16 A Yes.
17 Q And when you looked through it, did you
18 notice any handwriting aside from yours?
19 A I don't recall seeing any. I don't
20 recall. I don't believe so, no.
21 Q Okay.
22 A No.
0846
1 Q I want you to turn to page ten, page ten
2 of this exhibit.
3 A Okay.
4 Q Question 18.
5 A Uh-huh.
6 Q Is the answer written there, is that your
7 handwriting?
8 A It is.
9 Q Okay. And can you explain what you meant
10 or what was discussed with regard to internal
11 discussions?
12 A That was a comment made by Dr. Israelski
13 is that there, he has never actively in any of the
14 spring calls for proposals--
15 Q And I'm sorry. When you say "spring
16 calls," what are you referring to?
17 A This would have been the CMCR's request
18 for proposals that they send out from time to time.
19 Q They send them out in the spring?
20 A In one case, they had sent them out in the
21 spring. I don't know if that was a general rule or
22 not.
0847
1 Q Okay.
2 A But he had never through this process
3 sought a higher potency product than what he was
4 currently using for this study, which I believe was
5 around three-and-a-half percent. But he said that
6 he had some interest in potentially looking at
7 higher potencies and that was just internally
8 discussed.
9 Q Okay. And did he mention whether any
10 decisions had been made with regard to actually
11 requesting higher potencies?
12 A Actually, by inference, I would say no,
13 just because he stated that he had not sought a
14 higher potency marijuana product and that there
15 were some discussions on it.
16 Q Okay. And then I'd like to point your
17 attention to page 12 of the questionnaire.
18 A Uh-huh.
19 Q Okay. From reading this, we know that you
20 presented Dr. Israelski with a newspaper article?
21 A Yes.
22 MS. PAREDES: I'd like the witness to be
0848
1 shown Government Exhibit 30A, I believe.
2 THE WITNESS: I guess as a point of
3 clarification, this was via phone so we didn't
4 actually present him with the article, but we did
5 ask him if he knew of a San Mateo article dated
6 January 24 '03.
7 Thank you.
8 BY MS. PAREDES:
9 Q Look over Exhibit 30--is it 30A?
10 A 30A, yes.
11 Q And look up when you're finished.
12 A Uh-huh.
13 Q Do you recognize this exhibit?
14 A I do.
15 Q And what is it?
16 A This is one of the attachments that Dr.
17 Craker had sent to Frank Sapienza in June '03 when
18 he was trying to support his comment that
19 researchers are unhappy with the quality of the
20 marijuana that they received.
21 Q Okay. And is that the San Mateo County
22 Times article?
0849
1 A It is.
2 Q Okay. Now you mentioned earlier that this
3 interview was over the telephone. So what did you
4 tell Dr. Israelski about this article? I take it
5 he didn't have a copy in front of him.
6 A He did not have a copy in front of him. I
7 would have asked an open-ended question of are you
8 familiar with a newspaper article that was written
9 in the San Mateo newspaper regarding certain
10 comments made about the quality of marijuana in his
11 study.
12 Q And did he?
13 A He actually, he certainly knew about the
14 article, yes.
15 Q And what did he say about the article?
16 A He said that he was actually very careful.
17 He was interviewed for the article, and he said he
18 was very careful not to make any statements about
19 the quality, and that he could state equivocally
20 that he did not make any comments about the
21 quality.
22 He subsequently said that when he read
0850
1 this article, he stopped reading this paper in
2 whole, and actually considered writing a letter to
3 the editor of the newspaper.
4 Q Okay. Now, in the text of your
5 handwriting on page 12 of this exhibit--
6 A Uh-huh.
7 Q The second sentence from the bottom.
8 A Yes.
9 Q Beginning "Subject perception"?
10 A Yes.
11 Q When you write "subject," what are you
12 referring to?
13 A Well, this was in reference to Philip
14 Alden who is quoted in the article. Dr. Israelski
15 was the person who made this comment. He said, and
16 I'm paraphrasing, but basically the subject's
17 perception of quality is oftentimes different than
18 the principal investigator or the researcher's
19 perception of what quality means to them.
20 And that was his way, I think, of
21 separating himself from the comments made by the
22 patient that had interviewed in the newspaper
0851
1 article.
2 Q Did Dr. Israelski comment on Mr. Alden's
3 statement about having had bronchitis?
4 A Not specifically with regard to any
5 comments about bronchitis. I did not ask him
6 whether he had actually diagnosed him with
7 bronchitis or not, but he did say that in
8 retrospect he wished that he had the opportunity to
9 prescreen Mr. Alden's responses to the reporter and
10 he had not done so.
11 Q Okay. Now, I notice again at the bottom
12 of page 12, you handwrote your three points after
13 the interview.
14 A Yes.
15 Q Did you bring up these three points with
16 Dr. Israelski?
17 A Yes.
18 Q And have you heard from Dr. Israelski to
19 date?
20 A No.
21 MS. PAREDES: Okay. Your Honor, we ask
22 that Government Exhibit 19 be moved into evidence.
0852
1 MS. CARPENTER: I have no objection, Your
2 Honor.
3 JUDGE BITTNER: Okay. Government 19 is
4 received.
5 [Government's Exhibit No. 19
6 was marked for identification
7 and received in evidence.]
8 MS. PAREDES: Okay. We would ask that the
9 witness be handed Government Exhibit 20.
10 THE WITNESS: Thank you.
11 BY MS. PAREDES:
12 Q Mr. Strait, if you can look over this
13 document and look up at me when you're finished.
14 A Okay.
15 Q Do you recognize this document?
16 A I do.
17 Q What is it?
18 A This is the personal interview that I
19 conducted with Dr. Wallace face to face.
20 Q This was face to face?
21 A Yes, and this was on the following day.
22 He was unavailable that day, the day that we
0853
1 initially did our, the majority of our interviews,
2 but I came back to the center the next day before I
3 went over to the Scripps Institute to conduct this
4 interview.
5 Q Okay.
6 A Oh, I'm sorry. This was by phone. I
7 apologize.
8 Q This was--
9 A It was by phone.
10 Q Okay.
11 A But it was the following day.
12 Q Okay. And where were you physically?
13 A I was in the CMCR administrative building.
14 Q And the CMCR personnel that were present
15 were the people who were listed here?
16 A Yes.
17 Q And did they participate in any way in
18 your telephone interview?
19 A Not during the interview. Just to
20 coordinate getting the room set up for me.
21 Q Okay. Now, I notice that you were the
22 only one from Drug Enforcement Administration?
0854
1 A Yes.
2 Q And did this come to you directly from Ms.
3 Bentley?
4 A Yes.
5 Q Now did you notice any other handwriting
6 on this document aside from yours?
7 A Yes.
8 Q Okay.
9 A On page five where he corrected the
10 varying levels of THC content in the cigarettes
11 that he was approved to use.
12 Q That's question nine.
13 A Yes. And also question 16 on page nine
14 where he again made the correction to what he had
15 done on question nine.
16 Q And are those numbers that he--
17 A Yeah, it represents the THC content of the
18 cigarettes that he obtains from NIDA.
19 Q Okay. And it's 0, 1.4 and 7?
20 A Yes, it goes up to seven percent THC
21 content.
22 Q Okay. So other than those two exceptions,
0855
1 all the other handwriting is yours?
2 A Yes, except for on the first page where
3 Dr. Wallace provided me his phone number if I
4 needed to call him for any follow-up.
5 Q Oh, so--
6 A That was provided--
7 Q After your interview?
8 A Yes, after, after the interview.
9 Q Okay. And did you in executing this
10 questionnaire, did you follow the same procedures
11 that you did in the other three questionnaires?
12 A Yes, yes.
13 Q Okay. I'd like to direct your attention
14 to question ten on page six.
15 A Uh-huh.
16 Q I don't know if the original is cut off,
17 but the copies certainly are. Is that your
18 handwriting?
19 A It is.
20 Q Okay. And can you read what it says?
21 A Yeah. The question reads: Is the potency
22 of the current product consistent? And he said he
0856
1 can't comment other than to say, other to say that
2 the product falls within the range specified, which
3 would have been via UMiss' obligation to provide it
4 within a certain target zone.
5 He goes on to say, however, but even by
6 examining blood levels, it brings up questions as
7 to whether that would be an appropriate way to
8 address this question due to the fact that other
9 factors relating to the efficiency in which the
10 product was consumed would come into play.
11 Q Okay. Okay. Also, I'm sorry, on page
12 one, you wrote in what looks like another protocol
13 or another study.
14 A Yes.
15 Q Why did you do that?
16 A I had each principal investigator confirm
17 the protocols that they had approved, and in this
18 case, I had left out the protocol entitled
19 "Analgesic Efficacy of Smoked Cannabis."
20 Q Okay. So this investigator actually had
21 two at the time, protocols?
22 A Yes.
0857
1 JUDGE BITTNER: What are the words "after
2 cancer pain," "SF reduce."
3 THE WITNESS: This I believe referred to
4 the level of review that it was under. I can't
5 remember specifically what SF review meant, but it
6 was, there are multiple levels of scientific review
7 that each protocol goes under, so depending on
8 where the protocol is in that review process would
9 have been my comment there.
10 I think it--
11 JUDGE BITTNER: This was before the study
12 began or the results being--
13 THE WITNESS: Yes.
14 JUDGE BITTNER: What's being reviewed?
15 THE WITNESS: In fact, yeah, the protocol
16 that's listed with the number one actually implies
17 that it hadn't begun because it was still under and
18 I think it's state and federal review is what I
19 probably put there.
20 The CMCR protocols undergo scientific
21 review by the CMCR, by the state of California, and
22 then when it goes to the federal government, the
0858
1 PHS, it undergoes its federal review. That's a
2 somewhat lengthy process, and I believe, now
3 recollecting what that means, it's probably what I
4 had, my crib notes there.
5 JUDGE BITTNER: What's a refractory cancer
6 patent?
7 THE WITNESS: I don't know.
8 JUDGE BITTNER: Okay.
9 BY MS. PAREDES:
10 Q Mr. Strait, on page 12 at the very bottom,
11 is that your handwriting?
12 A Yes.
13 Q Okay. And did you go over these three
14 points with Dr. Wallace?
15 A I did.
16 Q And have you heard from him to date since?
17 A I have not.
18 MS. PAREDES: Okay. Your Honor, we move
19 that this exhibit be moved into evidence,
20 Government Exhibit 20.
21 MS. CARPENTER: No objection.
22 JUDGE BITTNER: Received.
0859
1 [Government Exhibit No. 20 was
2 marked for identification and
3 received in evidence.]
4 MS. PAREDES: And I'd like to have the
5 witness be handed Government Exhibit 21.
6 THE WITNESS: Thank you.
7 BY MS. PAREDES:
8 Q Mr. Strait, if you can look over this
9 document and look up at me when you're finished.
10 A Okay.
11 Q Do you recognize this Government exhibit?
12 A I do.
13 Q What is it?
14 A This is my phone interview along with Dr.
15 Sannerud back in D.C. after we had left. Dr.
16 Abrams was not available to meet, to come down to
17 San Diego from where he's located in San Francisco,
18 for our meeting, but we followed up, via phone,
19 with him when we got back to D.C. and this is the
20 questionnaire that we administered to him via
21 phone.
22 Q Okay. Do you remember if Dr. Abrams was
0860
1 in the initial CMCR meeting with Dr. Grant or by
2 telephone?
3 A I'd have to look back at Government
4 Exhibit 16.
5 Q So you were physically in Washington, D.C.
6 when you did this interview?
7 A Yes.
8 Q And everyone was on the telephone?
9 A Yes.
10 Q Okay. And who conducted this interview?
11 A I did.
12 Q And did Dr. Sannerud participate in any
13 way?
14 A She may have asked a follow-up question,
15 but I don't recall specifically.
16 Q Okay. And did the other CMCR employees or
17 personnel participate in the conversation?
18 A No.
19 Q Okay. And did you follow the same
20 procedure with regard to this telephone interview
21 that you did with the other telephone interviews
22 that you did?
0861
1 A Yes.
2 Q And did you receive this back from Ms.
3 Bentley?
4 A Yes.
5 Q And it was in the package with all the
6 other?
7 A Yeah. In this case, we actually had to
8 physically--I don't know--I don't recall if we
9 faxed this. No, we probably didn't because I don't
10 see any fax stamps on it, but we would have sent
11 this out to Ms. Bentley and then she would have
12 subsequently sent it out to Dr. Abrams.
13 Q Okay. Now I notice you have--well, you
14 looked it over and did you see any handwriting
15 that's not yours?
16 A Yes.
17 Q And can you point those out?
18 A Okay. It's page seven in the second box.
19 I learned that Dr. Abrams has the handwriting of
20 most doctors.
21 Q And what sentence is not yours, and what
22 handwriting is not yours?
0862
1 A I asked Dr. Abrams when he mentioned this
2 idea of harshness to explain what that meant to
3 him, and he indicated that it is the irritation of
4 the posterior pharynx and that good marijuana as he
5 says may cause coughing but this is not the same
6 type of cough that's created from harshness and he
7 gave me the comment, "If you don't cough, you don't
8 get off."
9 Q And that's someone else's handwriting, not
10 yours?
11 A That's my handwriting, but it's the
12 qualifying statement afterwards that's his.
13 Q Oh, the part in brackets?
14 A Yes. And I've spent some time studying it
15 so I can read it you if you'd like.
16 Q Okay.
17 A It says: Is an adage used by some to
18 explain positive benefit of a cough. However, this
19 is different cough than that caused by harsh
20 marijuana.
21 Q Okay. Do you know what he means there
22 from your conversation with him?
0863
1 A I think the only thing he's trying to
2 qualify is that this was a statement that he's
3 heard that distinguishes the fact you do cough from
4 smoking marijuana, but there's two different types
5 of cough.
6 Q Okay. Now, is there any other place in
7 this document which is not your handwriting?
8 A Actually, on that same, in that same box,
9 I actually had originally wrote, had originally
10 written larynx, and he corrected me by stating
11 pharynx.
12 Q And that's circled?
13 A And he circled that with the edit there.
14 I don't believe there are any other edits. I
15 apologize. On page 12, when I asked him the
16 question about recruiting, the first major bullet
17 point, sub-bullet three, I had identified that his
18 groups, the groups that were in his study, which
19 were Ns of 20 or so, group three, I had originally
20 stated that that patient population received
21 Marinol plus placebo, and he corrected me by
22 stating that it's not Marinol plus placebo, but it
0864
1 is, in fact, just a Marinol placebo. So he removed
2 the plus.
3 Q Okay. Okay. Now, going back, are those
4 the only places which are not your handwriting?
5 A Those are the only that I see.
6 Q Okay. I'd like to turn your attention to
7 page one.
8 A Okay.
9 Q Under "Protocols."
10 A Uh-huh.
11 Q Now there is some typewritten information
12 and then handwritten information.
13 A Yes.
14 Q Is that your handwriting?
15 A Yes, it is.
16 Q Okay. Now what is all the typewritten
17 information? What does that signify?
18 A What it signifies to me is that he has a
19 number of protocols that he submitted through the
20 CMCR and actually one predates the CMCR which is
21 his first study. I think it's probably the one
22 that Dr. Doblin referred to as being completed.
0865
1 And that actually has been published in
2 the Annals of Internal Medicine, which is my
3 handwritten note there. And that he subsequently
4 has four other protocols that at the time were
5 approved and ongoing or undergoing state and
6 federal review.
7 Q Okay. So in number two and number three,
8 what does the "ongoing" at the end of--
9 A It meant that they had been approved and
10 they were in active recruiting phase to recruit
11 patients, and when I read these off to him, he
12 qualified for me that number four was actually
13 approved and was planned on being started November
14 1, and I assume that would have been 2003.
15 Q So do you remember now what your notation
16 S/F review means?
17 A Yeah, I'm quite confident it meant state
18 and federal review.
19 Q Did that mean that it was, it had been
20 given state and federal positive review or was
21 pending review?
22 A It was a pending review there.
0866
1 Q Okay.
2 A It was a footnote for me to recognize that
3 although this state/federal review process is
4 lengthy, it was somewhere in that review process.
5 Q Okay.
6 JUDGE BITTNER: So the word "clear" means
7 approved?
8 THE WITNESS: In this case, he had given,
9 it had told me it was cleared, and it was starting
10 on November 1. So that would have meant that he
11 corrected my comment about it being under state and
12 federal review.
13 BY MS. PAREDES:
14 Q And then on my copy the year is cut off
15 from November 1. What was the year?
16 A 2003.
17 Q Okay. I'd like to turn your attention to
18 page, page seven, question 13.
19 A Yes.
20 Q Do you recall speaking with Dr. Abrams
21 about this question?
22 A Yes.
0867
1 Q Okay. And what, do you remember what he
2 meant by mimic? Is that the sixth word, mimic?
3 A Yes.
4 Q That which is being--what is that word?
5 A Consumed in the SF or San Francisco area.
6 Q Okay. And what did he mean by that?
7 MS. CARPENTER: Objection to the question.
8 The witness can certainly testify to what he said,
9 but not to what he meant.
10 BY MS. PAREDES:
11 Q What was your understanding as to what Dr.
12 Abrams meant by that?
13 MS. CARPENTER: That's the same question.
14 It's the same objection.
15 JUDGE BITTNER: Right. What did he say?
16 Did you report verbatim what he said?
17 THE WITNESS: To the best of my ability,
18 yes. And this is, these are my notes as to what he
19 said.
20 JUDGE BITTNER: Okay. Did he say anything
21 more than what you wrote?
22 THE WITNESS: Not that I recall.
0868
1 JUDGE BITTNER: Okay. Then I'll sustain--
2 THE WITNESS: But if I had, but if I had,
3 he certainly would have had the opportunity to make
4 those additions to the statement.
5 JUDGE BITTNER: Okay. So you didn't.
6 Then I'll sustain the objection.
7 BY MS. PAREDES:
8 Q Did Dr. Abrams say what his goal was in
9 regard to this question?
10 A No, I don't believe he stated specifically
11 what his goal was.
12 MS. PAREDES: Okay.
13 JUDGE BITTNER: Could we go back, please,
14 to page three, the second box, point three, very
15 serious flu-like symptoms based on consumption of--what is
16 that?
17 THE WITNESS: Interleukin.
18 JUDGE BITTNER: I'm sorry?
19 THE WITNESS: Interleukin-2.
20 JUDGE BITTNER: What is that?
21 THE WITNESS: I don't know.
22 JUDGE BITTNER: Okay.
0869
1 THE WITNESS: I know how to spell it, but
2 I don't know what it is.
3 JUDGE BITTNER: And the effect of cannabis
4 on interacting with these receptors?
5 THE WITNESS: Yes. This--
6 JUDGE BITTNER: Okay.
7 THE WITNESS: It was clear to me that this
8 was an area that he would like to pursue with
9 regard to future research interest with marijuana.
10 He had stated that one receives flu-like symptoms
11 based on--in his patient population.
12 JUDGE BITTNER: Okay.
13 THE WITNESS: Which I believe would be HIV
14 patient population. And Interleukin-2 must be a
15 product which is consumed to help with that. And
16 he'd liked to see how cannabis may affect that
17 interaction.
18 JUDGE BITTNER: Okay.
19 BY MS. PAREDES:
20 Q Going back to now again page seven,
21 question 13.
22 A Yes.
0870
1 Q Did you ask Dr. Abrams whether his
2 research was adversely affected by these
3 cigarettes?
4 A I think question 13 actually does ask that
5 question to which he said in this case yes.
6 Q And did you take that to be a complaint?
7 A I, when the respondent is asked to
8 respond--when they respond affirmatively, the idea
9 was to ask a follow-up question to get his
10 understanding of why he would have said yes. His
11 response, which is stated subsequently, is as
12 stated.
13 Q Okay. Okay. On page eight, the next
14 page, did Dr. Abrams say whether patients had
15 dropped out for other reasons other than harshness?
16 A I don't believe that he did in this
17 question.
18 Q Okay. On the third line, where it reads
19 "current 30, less have dropped."
20 A Right.
21 Q What is the "less" referring to? Less
22 than what?
0871
1 A I want to say that I recall something
2 about a protocol where the exclusion criteria was
3 changed slightly for one of his studies and that as
4 a result he's had less people dropping out of the
5 studies.
6 Q Okay. On page nine, the second block, is
7 that all of your handwriting?
8 A Yes, it is.
9 Q Okay. On the right hand side, where it's
10 underlined, it says "MAPS data."
11 A Yes.
12 Q And can you explain what this is in
13 relation to the rest of the writing?
14 A Yeah. Actually it was data that Dr.
15 Abrams had presented or information he had
16 presented that was used to partially respond to the
17 question. Dr. Abrams, I would say, probably had a
18 scientific curiosity as to many if not all
19 researchers that are true scientists to explore a
20 range of potencies, and so as he had stated in a
21 previous question, if the goal is to mimic that
22 which is perceived to be available on the street,
0872
1 and he presents MAPS data which suggests that there
2 is higher potency material available on the street,
3 then certainly that would be of interest.
4 Q So this is your notetaking of what Dr.
5 Abrams is telling you that MAPS data shows?
6 A Yes.
7 Q Okay. And the word next to ten to 12
8 percent.
9 A Yes.
10 Q Can you tell us what that word is?
11 A Yeah, paraphrasing, basically according to
12 MAPS or according to what Dr. Abrams said about the
13 MAPS data, the lowest potency available on the
14 street is about eight percent, but it's actually
15 closer to ten to 12 percent.
16 Q Oh, so that word is "closer"?
17 A Yes.
18 Q Okay.
19 JUDGE BITTNER: I'm sorry. And what was
20 on the second line in that box? But there were
21 questions?
22 THE WITNESS: From the SRB.
0873
1 JUDGE BITTNER: Which is what?
2 THE WITNESS: Scientific Review Board. An
3 important point. One of the layers of scientific
4 review of any protocol for merit is the location
5 where the study is to take place, they all have
6 scientific review boards who review the protocol.
7 And he had expressed during this portion
8 of the interview that he has an interest,
9 scientific curiosity, in looking at higher THC
10 containing marijuana cigarettes. However, there's
11 an obstacle or an obstruction at the level of the
12 university in getting them to approve such studies.
13 And so that's what he refers to as SRB.
14 He subsequently would have also stated that the
15 state of California would potentially have
16 difficulty if they couldn't get it through the SRB.
17 The SRB represents the first layer of review.
18 JUDGE BITTNER: Okay. And that's a
19 university organization?
20 THE WITNESS: And that is within the
21 University of California San Diego.
22 JUDGE BITTNER: And you have needs to be
0874
1 more education something.
2 THE WITNESS: It was his comment where he
3 said that the SRBs actually need to be more
4 educated on the effects of higher potency marijuana
5 before any studies could really go on at these
6 higher levels.
7 JUDGE BITTNER: Okay. So there needs to
8 be more education to them; is that?
9 THE WITNESS: Yes.
10 JUDGE BITTNER: Okay.
11 BY MS. PAREDES:
12 Q Okay. And then under MAPS data, where it
13 says "Dutch."
14 A Yes.
15 Q 14 to 19 percent. What's the word next to
16 that?
17 A Prescribed.
18 Q And what does that refer to?
19 A I don't recall the laws in Europe, but I
20 think what is meant there is that there is
21 marijuana that contains 14 to 19 percent THC which
22 is used for whatever purpose in that country.
0875
1 Q And it's a prescription? It's available
2 through prescription? Or?
3 A Well, marijuana is a Schedule I substance
4 and in Schedule IV of the Single Convention so I
5 don't know if it could be used for medical purposes
6 there or not.
7 Q Okay. Okay. Turning to page ten of the
8 exhibit, is this all your handwriting?
9 A Yes.
10 Q Okay. The handwriting outside the box,
11 the second box.
12 A Uh-huh.
13 Q Is this something that Dr. Abrams sent to
14 you?
15 A Yes.
16 Q And can you explain what that is?
17 A Yeah. This goes back, I think, partially
18 to the SRB approval and the California state
19 approvals, whenever work is being done, you know,
20 where patients are consuming Schedule I substances,
21 you can't go ahead and give a naive patient a
22 Schedule I substance because of issues of
0876
1 dependence and tolerability and probably more
2 dependence.
3 Q Excuse me. I'm sorry. When you say
4 "naive patient," what are you referring to?
5 A A patient that is naive to the use of
6 consuming a Schedule I substance such as marijuana.
7 Q Okay.
8 A So meaning that they've never consumed
9 marijuana before. So as a rule, these protocols,
10 and one of the exclusion criteria that is kind of
11 negotiated with these SRBs is the fact that you
12 will not use naive patients. So I think what he is
13 saying is that his, all of his protocols used
14 experienced or what we refer to as non-naive
15 marijuana uses, in which case his protocol is
16 actually further stipulated where 50 percent of his
17 consumers, of his patients are current consumers
18 and 50 percent are not current, meaning that they
19 have consumed, but at least six times in their
20 life. That is what he has defined or his protocol
21 defines as not current.
22 Q And that applies to all of his protocols
0877
1 that are listed on page one?
2 A That is what his comment was to me as I've
3 written it down.
4 Q Okay. Now under the typewritten word
5 "risk," you used the word or you write the word
6 "dysphoric."
7 A Yes.
8 Q Can you explain what that is?
9 A Yeah, I'm not a pharmacologist by
10 training, so I--
11 MS. CARPENTER: Excuse me. I'm just going
12 to object to the extent that he can talk about what
13 did Dr. Abrams said, but again his interpretation
14 of what Dr. Abrams said is not relevant.
15 JUDGE BITTNER: Yeah. Dr. Abrams said
16 dysphoric effect.
17 THE WITNESS: Absolutely, yes.
18 JUDGE BITTNER: Did you ask him what he
19 meant?
20 THE WITNESS: No, I didn't ask him
21 specifically what dysphoric meant.
22 JUDGE BITTNER: Okay. Then I'll sustain
0878
1 the objection.
2 BY MS. PAREDES:
3 Q On the last page, page 12, the second
4 handwritten line.
5 A Uh-huh.
6 Q You write "the completed N equals 20-21
7 PTS" and then an arrow.
8 A Yes.
9 Q "N equals 67."
10 A Yes.
11 Q Can you explain what that is?
12 A What it's meant to say is that when asked
13 the question of having problems with recruiting, he
14 stated for me that he has no problems with
15 recruiting and that as an example, in his completed
16 study, which had a protocol, predetermined number
17 of patients of 20 to 21 patients, he has had no
18 problems with recruiting.
19 I capitalized the "N" or he did perhaps--I'm not
20 sure which--but a capital N typically
21 refers to the total number of patients which I
22 think in this case is to be across all of his
0879
1 studies. Oh, actually I'm taking that back. I'm
2 taking that back.
3 There's only one patient population or
4 one--he's got three populations of patients that
5 are involved in his study. One patient population
6 is getting just marijuana cigarettes. To that the
7 lower case "n" is 20 to 21 patients.
8 Another group is receiving Marinol, which
9 is he said 20 plus patients. And then the third
10 group receives a Marinol placebo, which he says is
11 another 20 plus. So the capital "N" refers to the
12 fact that in total across his whole study in this
13 completed study, his "N" was 67.
14 Q Okay.
15 A That's what that refers to.
16 Q And then on the same page, the very
17 bottom, did you handwrite points to discuss after
18 the interview?
19 A Yes.
20 Q And did you follow, explain to him these
21 three points?
22 A Yes.
0880
1 Q And have you heard from Dr. Abrams since
2 receiving this document?
3 A No.
4 MS. PAREDES: Your Honor, the Government
5 asks that Government Exhibit 21 be admitted into
6 evidence.
7 MS. CARPENTER: Let me just look. There
8 was one other thing I couldn't read. Let me just--if I
9 could just get clarification on page nine, in
10 the second box, and it's number one, the third
11 line. Does that say "and funding agency"?
12 THE WITNESS: Yes.
13 MS. CARPENTER: Okay.
14 THE WITNESS: Which in this case would
15 have been the CMCR.
16 MS. CARPENTER: Okay. I have no
17 objection.
18 JUDGE BITTNER: Received.
19 [Government's Exhibit No. 21
20 was marked for identification
21 and received in evidence.]
22 MS. PAREDES: Okay. The witness can
0881
1 finally be handed Government Exhibit 21--22, sorry.
2 THE WITNESS: Thank you.
3 BY MS. PAREDES:
4 Q Mr. Strait, if you can look over this
5 document and look up at me when you're completed.
6 A Okay.
7 Q And do you recognize this document?
8 A I do.
9 Q What is it?
10 A After we met with the folks at CMCR we
11 actually knew, since we maintained the list of all
12 Schedule I researchers in the Office of Division
13 Control and in my section, we also knew that there
14 was an NIH or actually I believe NIDA-funded
15 researcher that was right down the street from CMCR
16 at a place called the Scripps Research Institute,
17 which actually receives marijuana from NIDA for
18 purposes of doing a drug abuse type of study.
19 And so we decided that since we were out
20 there, we would take the opportunity to cross over
21 and not only look at those that were looking at
22 potential therapeutic benefits of marijuana, but
0882
1 then also other researchers which are getting NIDA
2 marijuana.
3 Q Okay. And do you know what kind of
4 research Dr. Pollich was doing?
5 A Yes. Dr. Pollich is taking a look at
6 the--how the brain is affected by smoking
7 marijuana.
8 Q Now did you, is this the same
9 questionnaire that you used with the CMCR
10 investigators?
11 A It is.
12 Q Okay. Well, did you follow the same
13 procedure with Dr. Pollich that you did with the
14 CMCR investigators?
15 A I did.
16 Q Okay. Now this was in person?
17 A This was in person, yes.
18 Q Now, the only participants were you and
19 Dr. Pollich?
20 A It was, yes.
21 Q Okay. Now, who did you receive this
22 document from?
0883
1 A Actually I had him interviewed and then he
2 actually stood there or I stood there while he
3 reviewed my comments and initialed off on them.
4 Q Okay.
5 A So I was able to walk away with this on
6 that day.
7 Q Okay. And did Dr. Pollich have any
8 corrections or additions to your questionnaire?
9 A Not that I'm aware of.
10 Q And how long was this interview?
11 A This interview probably took about an hour
12 and a half because I got to take a look at his
13 facility and talk to him just a little bit about
14 his research.
15 Q Okay. Now even though he was not an CMCR
16 researcher, did you also cover then the
17 introductory remarks that are on page one?
18 A Yes, I did.
19 Q Okay. Okay. Now, with regard to page 12,
20 at the bottom of page 12 with your handwritten
21 notes.
22 A Uh-huh.
0884
1 Q Did you cover these with Dr. Pollich?
2 A Yes, I did.
3 Q And have you heard from his since you saw
4 him personally?
5 A No, I have not.
6 MS. PAREDES: Your Honor, the Government
7 requests that Government Exhibit 22 be admitted
8 into evidence.
9 MS. CARPENTER: Could I just voir dire the
10 witness?
11 JUDGE BITTNER: Uh-huh.
12 VOIR DIRE
13 BY MS. CARPENTER:
14 Q At the top, the front page, page one.
15 A Uh-huh.
16 Q There's no protocols listed. Was Dr.
17 Pollich involved in any protocols at the time?
18 A Yes, absolutely and it's because I didn't
19 know the title of the protocol prior to going out,
20 and he actually gave me a copy of one of his
21 publications, which I did not attach to this
22 document, but in talking to him, he provided me
0885
1 with his publication resulting from his marijuana
2 that he received and then also some of the
3 protocols that he was then forwarding back to get
4 additional funding from federal government.
5 Q Okay. And so what was the time period
6 covered by these protocols? When was he engaged in
7 this research?
8 A It was ongoing at that time.
9 Q At that time.
10 A In 2003.
11 Q And how far back did it go? Do you--
12 A Dr. Pollich, I don't recall specifically,
13 but it was prior to 2002.
14 Q So 2002, 2001, 2002, 2003?
15 A Yes.
16 MS. CARPENTER: Okay. I think with that
17 clarification, we have no objection, Your Honor.
18 JUDGE BITTNER: What is Dr. Pollich's
19 doctoral degree in?
20 THE WITNESS: I don't recall specifically.
21 JUDGE BITTNER: Okay. I'd like to know
22 that at some point.
0886
1 THE WITNESS: I can get that for you,
2 sure.
3 JUDGE BITTNER: Yeah. Since I usually
4 refer to the degree. Okay. With that Government
5 22 is received.
6 MS. CARPENTER: I'm sorry. Could I just
7 ask one more question? And I assume from this that
8 it was clinical research that he was involved in
9 with human patients?
10 THE WITNESS: Human patients, absolutely,
11 yes, and I'm sorry, Judge Bittner. Were you
12 referring to whether he's got an M.D. or Ph.D.?
13 JUDGE BITTNER: Or whatever?
14 THE WITNESS: He has a Ph.D.
15 JUDGE BITTNER: Okay.
16 THE WITNESS: He is not an M.D.
17 JUDGE BITTNER: Okay.
18 THE WITNESS: If that's sufficient, then?
19 JUDGE BITTNER: No, that's enough. I
20 don't need to know the field. It's just when I
21 identify individuals, I usually say what their
22 degree is. Okay. No objection?
0887
1 MS. CARPENTER: No objection, Your Honor.
2 JUDGE BITTNER: Received.
3 [Government's Exhibit No. 22
4 was marked for identification
5 and received in evidence.]
6 MS. PAREDES: Your Honor, we were
7 wondering if this might be a good time for a break?
8 JUDGE BITTNER: Okay. Any objection, Ms.
9 Carpenter?
10 MS. CARPENTER: Are we done with all the
11 CMCR? Or all--
12 MS. PAREDES: I'm not sure. No, no, we're
13 not.
14 JUDGE BITTNER: We're not done with all
15 the interviews?
16 MS. PAREDES: We're done with the
17 documentary interviews, yes, but we're not finished
18 questioning Mr. Strait on his interviews.
19 MS. CARPENTER: Oh, there's additional
20 interviews for which there are not documents?
21 MS. PAREDES: No. There's additional
22 questions for the interviews that we've just
0888
1 discussed.
2 MS. CARPENTER: Oh. I wonder if we could--
3 JUDGE BITTNER: How much more is there?
4 MS. PAREDES: Maybe about 15, 20 minutes
5 on this topic, not total for Mr. Strait, but on
6 this topic.
7 JUDGE BITTNER: Okay. But you'd like to
8 break for lunch now?
9 MS. PAREDES: Whenever.
10 MS. CARPENTER: I was just hoping we could
11 sort of finish this topic, but if it's going to go
12 on for awhile.
13 JUDGE BITTNER: Yeah, I'd kind of like to
14 finish the interviews, if we could. Okay. Is that
15 okay with you, Mr. Strait?
16 THE WITNESS: Fine by me.
17 JUDGE BITTNER: Okay.
18 DIRECT EXAMINATION (Continued)
19 BY MS. PAREDES:
20 Q Mr. Strait, with regard to the interviews
21 of the investigators that we've just talked about,
0889
1 did any of them--what was the, I guess the
2 atmosphere of your interviews?
3 A I tried to make it as loose and
4 comfortable as possible. It is the reason why I
5 created the introductory remarks the way I did.
6 And it is the reason why I made sure that I thanked
7 everyone at the end of the interviews because we,
8 in reading some of the comments that were provided
9 by the applicant, we were taken aback to say the
10 least that there would be this perception of DEA to
11 the researchers, and we remained exquisitely
12 sensitive to that.
13 Q Now, what was your impression with regard
14 to the researchers' openness with talking to you?
15 A I felt that no one that I spoke to had,
16 was holding anything back. I thought everyone was
17 comfortable and I think we just had a nice open
18 frank conversation.
19 MS. PAREDES: Okay. Nothing further.
20 Sorry.
21 JUDGE BITTNER: At all or on this subject?
22 MS. PAREDES: On this issue.
0890
1 JUDGE BITTNER: Okay.
2 MS. PAREDES: CMCR questions.
3 JUDGE BITTNER: Okay. So now you really
4 want lunch.
5 [Laughter.]
6 JUDGE BITTNER: Okay. Is an hour enough
7 time?
8 MS. CARPENTER: It's enough for us. I
9 know Mr. Bayly had mentioned this morning--
10 JUDGE BITTNER: Oh, you wanted an extra
11 long break. I'm sorry. Let's go off the record.
12 [Discussion held off the record.]
13 JUDGE BITTNER: Back on the record. We'll
14 recess for lunch and resume at 2:15 this afternoon.
15 Off the record.
16 [Whereupon, at 12:15 p.m., the hearing
17 recessed, to reconvene at 2:15 p.m., this same
18 day.]
0891
1 A F T E R N O O N S E S S I O N
2 [2:25 p.m.]
3 JUDGE BITTNER: Ms. Paredes.
4 MS. PAREDES: Yes, thank you, Judge
5 Bittner.
6 First, I apologize. Before we broke, I
7 said that that was the last of the interviews.
8 JUDGE BITTNER: Aha.
9 MS. PAREDES: There is one more, and I
10 would ask that the witness be handed Government
11 Exhibit No. 28.
12 Whereupon,
13 MATTHEW STRAIT
14 was recalled as a witness herein and, having been
15 previously duly sworn, was examined and testified
16 as follows:
17 JUDGE BITTNER: Hold on; let me see if I
18 have the Government--yes, never mind; I have them,
19 I think.
20 THE WITNESS: Thank you.
21 MS. PAREDES: Mr. Strait, if you can look
22 this document over, and when you're finished, look
0892
1 up at me.
2 JUDGE BITTNER: That's okay. We can go
3 ahead while I find them.
4 DIRECT EXAMINATION (Resumed)
5 BY MS. PAREDES:
6 Q Mr. Strait, do you recognize this
7 document?
8 A I do.
9 Q What is it?
10 A This is the questionnaire that I
11 administered to what was originally to be Dr. Billy
12 Martin at Virginia Commonwealth University, but
13 then, subsequently, he nominated Dr. Aaron Lichtman
14 to participate on his behalf.
15 Q And did you interview both doctors or just
16 one?
17 A Actually, I did. I spent a significant
18 amount of time discussing, and I should say myself
19 as well as Ms. Kaupang and someone from our
20 Richmond field office, Melanie Mattocks. We did
21 actually spend a significant amount of time with
22 Dr. Martin. Dr. Martin has basically been heavily
0893
1 or for a long time involved in marijuana and
2 different research efforts.
3 He's been on both sides, too. He's been
4 in the research community as an active researcher
5 for more than 30 years and also on the pseudo
6 government side. He's been, according to him,
7 involved in some of the PHS review processes for
8 marijuana protocols.
9 JUDGE BITTNER: Public Health Service.
10 THE WITNESS: Yes, ma'am.
11 JUDGE BITTNER: Okay; and do you know what
12 Dr. Lichtman's degree is?
13 THE WITNESS: Ph.D.
14 JUDGE BITTNER: Okay.
15 BY MS. PAREDES:
16 Q And Mr. Strait, after the first line,
17 where it says name, Billy Martin, comma, and it
18 says Ph.D.I--
19 A That would be a typographical error.
20 Q Thank you.
21 A Yes.
22 Q So this was an in person interview?
0894
1 A Yes, it was.
2 Q And did you follow the same procedures
3 with this interview that you did with the other
4 CMCR in person interviews?
5 A The procedure was the same, yes.
6 Q Now, when you looked this over, did you
7 see any handwriting that's not yours?
8 A I don't believe so; no, I believe it's all
9 my handwriting.
10 Q Now, as far as the attendees and
11 participants, did any of the Drug Enforcement
12 Administration personnel participate in the
13 interview, aside from yourself?
14 A Yes, Helen Kaupang was in the interview.
15 Q Well, I'm sorry; I'll rephrase that. Did
16 Ms. Kaupang or Ms. Mattocks participate in terms of
17 speaking with the investigators?
18 A Actually, Ms. Kaupang may have had some
19 follow-up questions that would have been
20 incorporated into the document. Like I said in my
21 previous testimony, it was the two of us that were
22 really initially the ones that were asked to go out
0895
1 and conduct these interviews. Hurricane Isabel
2 prevented her from going to CMCR, but she was on
3 tap for this trip.
4 Q And this trip was in Virginia.
5 A Yes, it was.
6 Q And then, did Ms. Mattocks participate in
7 the interview at all?
8 A Only to be available to meet us and to sit
9 down with Dr. Martin, but she did not participate
10 in the questionnaire.
11 Q And then, did Dr. Lichtman participate in
12 terms of providing information?
13 A Yes; actually, Dr. Martin sat with us for
14 the first 45 minutes, and then, he actually left,
15 and this was before the interview was or the
16 questionnaire was implemented, and he brought in
17 Dr. Lichtman. And Dr. Lichtman is actually the
18 person responsible or the person who responded to
19 the questionnaire.
20 Q Okay; and to your knowledge, did you show
21 Dr. Martin the questionnaire at all?
22 A We actually had wanted to do the
0896
1 questionnaire with him specifically but actually
2 never ended up showing him the questionnaire,
3 because as he said, he's gone onto more
4 administrative aspects of the department, and if we
5 really wanted to get the true answers about the
6 quality or quantity or potency of this stuff, we
7 really needed to speak with a gentleman who had
8 been interacting with it on a daily basis, which
9 was Dr. Lichtman.
10 Q So with either or both Dr. Lichtman and
11 Dr. Martin, did you go through verbally your
12 introductory remarks that are printed on page 1?
13 A I did with the exception of the one cross-out, and
14 it's an interesting distinction. Like I
15 said, we went and interviewed both researchers that
16 were doing work in human subjects, had been kind of
17 referred to as clinical studies or medical
18 marijuana studies, and then, we also tried to
19 identify some researchers that were doing animal
20 studies that might be of the drug abuse nature or
21 of some other nature.
22 And actually, Dr. Lichtman and Dr. Martin
0897
1 participated in the latter. Their research has
2 been involved with animals.
3 Q Okay; and I also notice on page 1, there
4 are no protocols listed.
5 A Yes.
6 Q To your knowledge, did they have any
7 ongoing research with NIDA marijuana?
8 A Yes, they did. I also believe that Dr.
9 Martin has an extensive resume with regard to
10 publications in the field of marijuana, and I
11 didn't solicit that vita or that list, but we all
12 understood his background in marijuana, in
13 marijuana research. So there was not a need to
14 list it.
15 JUDGE BITTNER: What is, presumably, Dr.
16 Martin's degree? Ph.D. or--
17 THE WITNESS: Ph.D., and I believe it's in
18 chemistry.
19 JUDGE BITTNER: Okay.
20 BY MS. PAREDES:
21 Q Now, I would like to direct your attention
22 to page 3 of the exhibit, the second block with
0898
1 handwriting in it.
2 A Yes.
3 Q Is that your handwriting?
4 A Yes, it is.
5 Q With regard to note one, the second
6 paragraph that's indented of it starts this study.
7 A Yes.
8 Q Can you read that?
9 A This study was rated, and there could be a
10 set of quotes there, as high, by--I believe that's
11 supposed to be NIDA slash NIH, but there is not
12 funding for this at present. What this means is
13 that they do have future research interests, and
14 they have submitted a protocol to NIDA or NIH, and
15 forgive me, but it is using animals and assessing
16 sensitization of marijuana.
17 But that had undergone some review by the
18 Federal Government for funding, and it had been
19 given a rating by the Federal Government.
20 Q And was that rating high, is high a term
21 of art?
22 A He used it as--I would say as a term of
0899
1 art, where it is something that in their community
2 is understood as a favorable rating to obtain
3 funding.
4 Q Okay; and then, in note two, the indented
5 paragraph, and it looks like there's a star, and
6 then, it starts Dr. Martin.
7 A Yes.
8 Q Can you read that sentence?
9 A Dr. Martin alluded to this as fortifying
10 marijuana.
11 Q And did he say fortifying?
12 A Yes, this was something that was discussed
13 in our first 45 minute session with Dr. Martin.
14 Dr. Martin has had--I don't know the best way to
15 say this--has interacted with a lot of private
16 pharmaceutical companies that are engaged in active
17 research looking at certain substances for
18 potential therapeutic value, which I think I may
19 have mentioned may be inherent in the marijuana
20 plant or may be slightly altered from compounds in
21 the marijuana plant. It's kind of in a discovery
22 phase right now.
0900
1 And he said that there are certainly
2 interests, their future interests, to look at some
3 of these compounds and see what kinds of effects
4 they may have in their animal models that they have
5 developed over the years. My comment here is that
6 with regard to the availability of such compounds
7 to complete this research, he said there is a
8 process of what he referred to as fortification, so
9 that if you didn't have a product that was suitable
10 for your research need, what you could do is
11 actually take, in this case, a marijuana cigarette
12 and fortify it, either with a dropper or some kind
13 of pipette or something, and actually infuse into
14 it the amount of the active drug of interest.
15 And so, that is a way, an inherent way in
16 which researchers get around the idea of not
17 necessarily having precisely what it is that they
18 require for a research project.
19 Q I'd like to direct your attention now to
20 page 5 of the exhibit, question eight. There's
21 handwriting to the far right of the page.
22 A Yes.
0901
1 Q Is that your handwriting?
2 A Mm-hmm.
3 Q And can you read what that handwriting is,
4 beginning with they have?
5 A Yes, they have received, and the idea is
6 bulk, marijuana. They don't get marijuana
7 cigarettes, because they're not distributing it or
8 giving it to humans. They get it in bulk. And
9 then, they actually hand roll it themselves, and
10 they've received bulk marijuana at what he refers
11 to as--
12 Q I'm sorry; there's--beginning parentheses
13 and then number three.
14 A Yes, it's, I'm sorry, 3 percent. It's
15 meant to be 3 percent THC.
16 Q Okay; and that refers to the bulk
17 marijuana.
18 A Yes, the THC content of the, quote, active
19 marijuana.
20 Q Okay; and then, the third line, which is
21 in quotes.
22 A It says ditchweed.
0902
1 Q Okay; ditchweed. And then, there's an
2 arrow that goes down. Can you read what it goes
3 down to?
4 A It says natural placebo. So based on this
5 comment, if I could summarize, that what they
6 receive from NIDA is three different products. One
7 is bulk material, which contains 3 percent THC.
8 Another is a placebo, which would be bulk material
9 where the THC has been actively removed by the
10 University of Mississippi.
11 And then, the third product would be a
12 strain of marijuana which just naturally does not
13 contain much THC. I can't say that it contains
14 zero. That probably would be inaccurate but very
15 little.
16 JUDGE BITTNER: Is that the ditchweed?
17 THE WITNESS: That's what they refer to it
18 as ditchweed. He refers to it as ditchweed. I had
19 to actually ask him what ditchweed was, and that
20 was his explanation.
21 JUDGE BITTNER: It's a strain of marijuana
22 that contains very little THC.
0903
1 THE WITNESS: It's commonly referred to as
2 hemp, maybe.
3 JUDGE BITTNER: Okay.
4 THE WITNESS: That might be the best way
5 to explain it.
6 JUDGE BITTNER: Okay.
7 BY MS. PAREDES:
8 Q And then, also with regard to question 8,
9 the box, the first box, there is handwriting, and
10 it's the third line of handwriting.
11 A Yes.
12 Q It says slight difference in swell.
13 A It's actually smell.
14 Q Oh, smell.
15 A Yes.
16 Q I was going to ask you if that was a term
17 of art.
18 A Dr. Lichtman, actually, was able to
19 provide the most amount of information about what
20 he recognized as the difference between placebo and
21 active marijuana or THC-containing marijuana.
22 JUDGE BITTNER: The next line, the
0904
1 reference ditchweed doesn't burn as fast as
2 placebo.
3 THE WITNESS: Yes.
4 JUDGE BITTNER: You mean that ditchweed
5 doesn't burn as fast as the placebo marijuana does?
6 THE WITNESS: Yes, yes.
7 JUDGE BITTNER: Oh, okay.
8 THE WITNESS: Yes.
9 BY MS. PAREDES:
10 Q Okay; now, Doctor, on the bottom right
11 hand corner of the questionnaire, you see initials
12 and then a date.
13 A Yes.
14 Q Did you witness Dr. Lichtman putting his
15 initials there?
16 A Yes, we conducted these interviews on
17 December 18, interview, and he actually did do that
18 for us on the spot.
19 Q Now I notice on the last page, page 12,
20 you did not write down your commonly used three
21 wrapup questions for the interviewers. Did you do
22 that with Dr. Lichtman?
0905
1 A I would say I probably didn't in this.
2 Q Did not?
3 A I probably did not. I probably would have
4 written it down if I had.
5 MS. PAREDES: Okay.
6 Your Honor, the Government requests that
7 Government Exhibit No. 28 be entered into evidence.
8 MS. CARPENTER: No objection, Your Honor.
9 JUDGE BITTNER: Received.
10 [Government Exhibit No. 28 was
11 received in evidence.]
12 MS. CARPENTER: I'm sorry; I meant to ask
13 one question about that. At the top, it says
14 attachment number one. I just--
15 JUDGE BITTNER: At the top of page 1,
16 right.
17 MS. CARPENTER: I think it's in your
18 handwriting.
19 THE WITNESS: It's not my handwriting, but
20 it's the handwriting of Helen Kaupang, who I
21 believe was responsible for the trip report, which
22 was the internal document that we wrote for
0906
1 management within DEA. So this would have been
2 referred to in that document as attachment number
3 one. It has no bearing for this.
4 BY MS. PAREDES:
5 Q Okay; Mr. Strait, what else did you do
6 with regard to Dr. Craker's application?
7 A Well, we did a bunch. We did a bunch of
8 things. We went to the CMCR. We went to
9 University of Mississippi and spoke to Dr. El-Sohly
10 and interviewed with him. We went to the Research
11 Triangle Institute, and on our way back is when we
12 stopped at VCU.
13 JUDGE BITTNER: Now, who is we again?
14 THE WITNESS: This would have been the two
15 of us who were assigned to this project, which was
16 Helen Kaupang and myself.
17 JUDGE BITTNER: So you went by yourself to
18 California.
19 THE WITNESS: CMCR only, yes.
20 JUDGE BITTNER: And she went with you to
21 Mississippi and to North Carolina and to--
22 THE WITNESS: Yes.
0907
1 JUDGE BITTNER: Richmond.
2 THE WITNESS: Yes
3 We went to speak to the folks at NIDA. We
4 went to HHS headquarters in Washington, D.C., and
5 spoke to them as well as FDA. FDA was on via
6 conference call. But we conducted numerous
7 investigations.
8 BY MS. PAREDES:
9 Q I'd like to direct your attention to a
10 meeting with NIDA.
11 A Mm-hmm.
12 Q And what does NIDA stand for?
13 A National Institute on Drug Abuse.
14 Q And when was that meeting?
15 A Let's see; I would say that it was in
16 January, mid-January 2004.
17 Q And who was present at that meeting?
18 A This would have been myself and Helen
19 Kaupang, and then, we had three representatives
20 from NIDA, four representatives from NIDA, three of
21 which I remember: Steve Gust was one; Tim Condon,
22 I believe, was the second.
0908
1 Q Can you spell Condon?
2 A C-O-N-D-O-N, and Mr. Gormley; I can't
3 recall his first name.
4 Q And can you spell Gormley?
5 A G-O-R-M-L-E-Y, and I can't remember the
6 name of the fourth individual, and of course, he
7 was probably second in charge.
8 JUDGE BITTNER: While we're on name
9 spellings, what is the name of the investigator, I
10 think is from Richmond, Melanie?
11 THE WITNESS: It was Mattocks, I believe--
12 JUDGE BITTNER: M-A-T-T--
13 THE WITNESS: I believe M-A-T-T-O-C-K-S.
14 JUDGE BITTNER: Okay; thank you.
15 BY MS. PAREDES:
16 Q Was anyone else at this meeting aside from
17 the people you just listed?
18 A No.
19 Q What was the purpose of this meeting?
20 A We felt it was important since there were
21 comments being made in the application about the
22 process of obtaining NIDA marijuana, we thought it
0909
1 was important to go to NIDA, learn what that
2 process was and to actually just get some
3 background about the marijuana cultivation program
4 at the University of Mississippi. It was more, I
5 would say, fact finding.
6 Q Would you describe it as getting just
7 background information for your purposes?
8 A Yes.
9 Q Now, was this before or after going to
10 interview CMCR investigators?
11 A This was after.
12 Q Okay; and just briefly in general, what
13 did you learn from that meeting?
14 A This is where we learned about the
15 contract that NIDA has had and the National
16 Institute on Mental Health, its predecessor agency
17 had before them since 1968 with the person group
18 institute that was awarded the contract since then
19 was the University of Mississippi. We learned that
20 the contract was free and open competition and that
21 anyone had the capability of pursuing that contract
22 if they were interested.
0910
1 We learned a little bit what was included
2 in the contract with regard to the cultivation of
3 marijuana at NIDA's discretion, the idea of having
4 to analyze samples for DEA, a whole monitoring
5 program for monitoring seized samples of marijuana,
6 so it was fact finding in regard to what we were
7 truing to gather from them.
8 Q Now, Mr. Strait, did you yourself visit
9 anyone else in terms of acting on Dr. Craker's
10 application?
11 A I believe other than those that I
12 mentioned previously, I don't believe we went to
13 see anyone else.
14 Q Do you recall when you were in San Diego--
15 A Yes.
16 Q --visiting La Jolla and Hillcrest?
17 A Yes.
18 Q When did you do that?
19 A That was in September of 2003. It was
20 part of the CMCR trip that we had some of the
21 administrative folks from CMCR, specifically Dr.
22 Mattison and Ms. Bentley had actually taken us
0911
1 around the facility, around the campus to learn
2 about the handling of the marijuana that they
3 received for NIDA to do--to execute their approved
4 study programs.
5 Q And what campus was this?
6 A This would have been the UC-San Diego
7 campus. I guess you could consider it the La Jolla
8 campus. I don't know if there's another campus in
9 San Diego affiliated with the University of
10 California.
11 Q Now, I'd like to direct your attention to,
12 then, when you were in La Jolla. I assume that's
13 in San Diego.
14 A Yes, both the Hillcrest facility and the
15 La Jolla center that I mentioned were both in San
16 Diego. I think we may have had to get in a car to
17 travel between the two, but by and large, they're
18 at the same location.
19 Q Now, what was the purpose of visiting
20 these two facilities?
21 A We wanted to learn specifically about how
22 the University of California handled marijuana and
0912
1 specifically to learn about how DEA had worked with
2 them to identify this protocol for handling the
3 drugs in a way so they wouldn't be diverted.
4 Q Okay; and did you learn what the protocol
5 was?
6 A Generally, yes.
7 Q Can you explain what that is?
8 A Sure; the study protocols that had been
9 approved by the CMCR and funded used patients that
10 were either inpatient folks, meaning those that
11 were in a hospital setting, or outpatient folks, in
12 which case the patient or the subject enrolled in
13 the study would actually have to visit the campus
14 in order to get the marijuana that they required.
15 So they had methodologies for dealing with
16 both and two different sites. The Hillcrest
17 Research Facility, if I'm not mistaken, was the
18 site where the inpatients were located. The way
19 that worked was the principal investigator, weeks
20 before getting ready to begin, would request via
21 222, DEA Form 222, marijuana. That 222 would go to
22 NIDA. NIDA would authorize the University of
0913
1 Mississippi to actually go ahead and transfer or
2 deliver the stuff to San Diego.
3 It was received at UC-San Diego's
4 pharmacy, which was located in the Hillcrest
5 building, so in the same location is where these
6 patients were located, and then the medicine was
7 delivered, or the substance was delivered
8 consistent with the way all other medicines were
9 delivered in a hospital setting. That which wasn't
10 used on the spot was then sent back to the pharmacy
11 and stored under lock and key.
12 For outpatient subjects, the same protocol
13 for obtaining the marijuana from the University of
14 Mississippi through NIDA was done. The material
15 had gone to the pharmacy. And then, once a week,
16 the La Jolla facility that was mentioned earlier
17 would make a trip over to the pharmacy and pick up
18 the amount of marijuana which was necessary for
19 that five-day period in which subjects would be
20 brought through their protocols.
21 And there were multiple protocols going on
22 at any given time, so certainly, it probably was a
0914
1 little bit of a task to identify how much was
2 necessary for the week.
3 But then, what would happen is a guard
4 would travel along with the marijuana from the
5 pharmacy back to this outpatient facility where it
6 would be retained under lock and key, and there was
7 all sorts of monitors to make sure that the stuff
8 wasn't going to be left unmonitored throughout the
9 time that it was there, and that material which was
10 not consumed during that week was returned back to
11 the pharmacy on Friday prior to the weekend
12 beginning by armed security, where it would stay
13 back in the pharmacy.
14 Q Now, you mentioned, you alluded to there
15 being monitors.
16 A Yes.
17 Q What did you mean when you say monitors?
18 A Basically cameras and motion detectors. I
19 don't claim to be an expert in this area. I'm not
20 a diversion investigator, but it is some of the
21 training that the diversion investigators within
22 DEA receive prior to them going out to the field.
0915
1 The diversion investigators who assisted in the
2 CMCR interviews, Ms. Bartalomeo and the other
3 person whose name is escaping me now were probably
4 the two individuals who assisted in working with
5 CMCR to develop this protocol.
6 MS. PAREDES: Okay; nothing further from
7 this witness.
8 JUDGE BITTNER: Mr. Strait, do you know
9 why DEA spells marijuana with an H, and HHS
10 apparently spells it with a J?
11 THE WITNESS: I've used it
12 interchangeably. I know in our regulations, it's
13 spelled with an H, so when we give out quotas, we
14 spell it with an H. But I have seen it more
15 commonly used with a J.
16 JUDGE BITTNER: Okay; I just wondered if
17 there was some signal I was missing.
18 THE WITNESS: We've had documents where
19 we've actually had to list it both ways depending
20 on whether or not we were referring back to the
21 C.F.R. or not so--
22 JUDGE BITTNER: Okay.
0916
1 MS. CARPENTER: It's a level of Government
2 complexity that just makes me shudder.
3 JUDGE BITTNER: Well, you never know if
4 maybe, you know, it's like the difference between
5 cannabis and marijuana. Are you sending some sort
6 of a signal by spelling it one way or the other
7 that I maybe didn't intend to send?
8 Okay; cross.
9 MS. CARPENTER: Sure. I don't think we'll
10 have time to get finished today, but we'll
11 certainly get started. If I could take just one
12 minute, Your Honor.
13 JUDGE BITTNER: Sure.
14 MS. CARPENTER: Actually, it would be
15 helpful for us to take 10 minutes.
16 JUDGE BITTNER: Sure. Off the record.
17 [Recess.]
18 MS. CARPENTER: Thank you, Your Honor.
19 CROSS-EXAMINATION
20 BY MS. CARPENTER:
21 Q Mr. Strait, I'm Julie Carpenter, counsel
22 for Respondent, just to let you know who I am.
0917
1 I'll be asking you a few questions.
2 A Sure.
3 Q You talked first that you often work in
4 conjunction with other offices. Can you tell me
5 what the process is at DEA when applications for
6 licenses such as the one Dr. Craker submitted are
7 received? What happens to them?
8 A Sure; an application is received by the
9 Office of Diversion Control. They're submitted to
10 our registration unit. The registration unit, in
11 the case of bulk manufacturers of Schedule 1s and
12 2s, which obviously this pertains, as well as
13 importers of Schedules 1s and 2 substances, there
14 is a whole registration process which is aside from
15 all the other registrant types with the exclusion
16 of Schedule 1 researchers, which is another subset
17 of the registration process.
18 Typically, when an application is
19 received, it gets a control number by the
20 registration group. That's about the only thing
21 they do. They look at it for completeness, which
22 is now not an issue, because you can do this
0918
1 online. And it gets a control number, and it gets
2 forwarded to the appropriate section.
3 And now, as a result of a September 2004
4 reorganization, this process falls within our
5 section. Now, I testified earlier that it was in a
6 different section that I referred to as ODO, and
7 that section no longer exists. So we changed
8 things around a bit. But now, it gets forwarded to
9 our section, to a unit which was created which I
10 mentioned that I assist with, and that's the
11 regulatory unit.
12 Q Okay; let me just interrupt you and ask
13 you; I'm talking specifically in 2001.
14 A Oh.
15 Q Which I think is when the application
16 was--
17 A Sure.
18 Q --submitted; I'm sorry.
19 A In 2001, I'm not sure really to the extent
20 I can talk about it just because I wasn't involved
21 in the registration process at that time.
22 Q Okay; but it would have been sent at that
0919
1 time to ODO?
2 A It would have been sent at that time to
3 ODR.
4 Q ODR?
5 A Just like I mentioned, registration unit.
6 JUDGE BITTNER: I think it would be better
7 if you used the names instead of the acronyms.
8 MS. CARPENTER: I think so, too.
9 THE WITNESS: Okay.
10 JUDGE BITTNER: Because in all these
11 years, I still don't get them straight.
12 THE WITNESS: Okay.
13 JUDGE BITTNER: So office of--
14 BY MS. CARPENTER:
15 Q Office of something, I guess.
16 A The registration section of the Office of
17 Diversion Control. And where it would have gone at
18 that time would have been to a diversion
19 investigation working in that section.
20 JUDGE BITTNER: Could I just ask before we
21 get there, just in terms of the organizational
22 chart, the Office of Diversion Control is within
0920
1 the--
2 THE WITNESS: Office of Operations.
3 JUDGE BITTNER: Office or division?
4 THE WITNESS: Division.
5 JUDGE BITTNER: Division of Operations;
6 okay.
7 THE WITNESS: Yes.
8 JUDGE BITTNER: And then, the Office of
9 Diversion Control has sections?
10 THE WITNESS: Yes.
11 JUDGE BITTNER: And how many now?
12 THE WITNESS: Now, I believe it's five.
13 JUDGE BITTNER: And in 2001, if you know?
14 THE WITNESS: I think it's five as well
15 but--
16 JUDGE BITTNER: But they're different.
17 THE WITNESS: But they're different. And
18 then, within each section, there's units.
19 JUDGE BITTNER: So it goes division,
20 office, section, unit.
21 THE WITNESS: Yes.
22 MS. CARPENTER: I'll try and keep those
0921
1 straight, too.
2 BY MS. CARPENTER:
3 Q So in 2001 when the application came in,
4 it would have been sent to the registration section
5 of the Office of Diversion Control.
6 A Yes.
7 Q Not division; okay, and then, where would
8 it have gone within that office?
9 A It would have gone to a diversion
10 investigation.
11 Q Diversion investigator.
12 A Who worked in that section at the time.
13 Q So it would be assigned to one person?
14 A Yes.
15 Q Okay; and do you know in this case who was
16 assigned to Dr. Craker's evaluation?
17 A Only by reference to the historical file.
18 I've seen one of two people who had been involved
19 in the capacity, and the first person was Sharon
20 Lick, and the other person is a gentleman named Don
21 Hickman.
22 Q Okay; now, the first time you heard of
0922
1 this application, I think you testified on direct
2 was in 2002.
3 A October.
4 Q October of 2002; okay. And you're aware
5 that the application was originally sent in dated
6 June 2001; is that correct?
7 A At that time, no I had not.
8 Q But you're aware of that as you sit here
9 now.
10 A Yes.
11 Q And do you know what could have happened
12 to it between June 2001 and October 2002 when it
13 came to your attention?
14 A If you'd like me to speculate, I certainly
15 will.
16 Q I'd be happy to have you speculate.
17 A Okay; I can tell you that the Office of
18 Diversion Control in 2001 had been getting a little
19 bit of criticism from the Administrator of the DEA
20 at that time for not advising the Administrator of
21 certain activities that were going on with regard
22 to Schedule 1 research in marijuana, and that we
0923
1 had been registering certain folks to do marijuana
2 research, and we weren't advising the other
3 building. That's a big no-no in DEA.
4 JUDGE BITTNER: The other building being--
5 BY MS. CARPENTER:
6 Q Yes, I was just going to ask for
7 clarification on that.
8 A Yes.
9 Q The other building?
10 A The administration, the Administrator.
11 Q The administrator.
12 A Yes. And I'm speculating that as a
13 result, there was a virtual paralysis when anything
14 came out with regard to marijuana as a result of
15 kind of the beating that the office took. So I
16 don't know precisely why or what happened in 2001
17 with the application, but I've often thought that
18 that probably had something to do with the reason
19 why it really didn't move.
20 Q Okay; and so, tell me a little bit about
21 this beating that was taken. What was the problem
22 with the registration being granted?
0924
1 MS. PAREDES: Objection; foundation.
2 Calls for speculation. Outside the scope of
3 direct.
4 MS. CARPENTER: Well, he just testified
5 about--
6 JUDGE BITTNER: Overruled. If you could
7 just expand on that a little bit.
8 THE WITNESS: Sure; the Administrator had
9 come back to the office head at the time and had
10 informed the office head that anything and
11 everything involving marijuana must go through the
12 Administrator.
13 BY MS. CARPENTER:
14 Q And who was the Administrator at the time?
15 A I don't recall precisely who was the
16 Administrator during that time.
17 JUDGE BITTNER: Are we talking when?
18 THE WITNESS: June 2001. Was it Mr.
19 Marshall?
20 JUDGE BITTNER: I would entertain a
21 stipulation that--let me see if I've got this
22 right--I'm looking to Mr. Bayly here; that Donnie
0925
1 Marshall was the Administrator in early 2001.
2 MR. BAYLY: Ooh, I believe so.
3 JUDGE BITTNER: This is embarrassing.
4 MS. CARPENTER: Your secret is safe with
5 me, everybody.
6 MR. BAYLY: We go through them pretty
7 quick--well, sometimes, I'll say. Some stay and
8 some move in--
9 JUDGE BITTNER: Asa Hutchinson became
10 Administrator in August of 2001.
11 MS. CARPENTER: August of 2001.
12 JUDGE BITTNER: If you'd like to stipulate
13 to that.
14 THE WITNESS: August of 2001.
15 JUDGE BITTNER: Mr. Bayly, could you--
16 MR. BAYLY: Yes.
17 JUDGE BITTNER: Ms. Carpenter, are you in
18 a position to?
19 MS. CARPENTER: I do not know, Your Honor,
20 but I'm happy to accept your word.
21 JUDGE BITTNER: Well, I don't like to
22 bring evidence.
0926
1 MS. CARPENTER: We can figure that out.
2 JUDGE BITTNER: I could go through the
3 organization charts, if you like.
4 MS. CARPENTER: I think we may have
5 someone looking that up right now.
6 JUDGE BITTNER: But I believe in the
7 summer of 2001, it was Mr. Marshall.
8 MS. CARPENTER: Okay.
9 BY MS. CARPENTER:
10 Q And to your knowledge, had there been
11 improper registrations, registrations where people
12 were researching with medical marijuana that were
13 improper somehow?
14 A No, no, really what it was was the
15 Administrator at the time had been asked in an
16 interview on TV or in the public media, and he just
17 frankly was not aware of it and insisted from that
18 point on he would make sure that he was made aware
19 of it.
20 Q And this related to any registration for
21 any use of marijuana whatsoever, any research use
22 of marijuana whatsoever, that is, medical or
0927
1 scientific or--
2 A Yes.
3 Q --or industrial?
4 A Yes.
5 Q Okay; do you know if Ms. Lick was sort of--do you
6 know if anyone was particularly named in
7 this, you called it beating up?
8 A No; I was not involved.
9 Q Okay; all right; are there still some
10 books up there?
11 A Yes.
12 Q Exhibit books? If you could turn to--oh,
13 actually, I don't think it's up there. It's
14 Government's Exhibit No. 2, but I don't think it's
15 there.
16 A Yes, I don't have Government Exhibits.
17 Thank you.
18 Q If you'd turn to the third page of
19 Government's Exhibit No. 2.
20 A Yes.
21 Q And I think you mentioned a control
22 number. Did you say where on the application the
0928
1 control number would go?
2 A It doesn't go on the application.
3 Q It's an internal number?
4 A It's an internal number.
5 Q And written up in the corner there in
6 handwriting is D1640 and then a bunch of other
7 numbers.
8 A Yes.
9 Q In the right hand corner; do you see that?
10 A I do.
11 Q Do you know what that is?
12 A I don't.
13 Q All right; and let me ask you who would
14 have stamped this when it came into the DEA's
15 office with that date stamp, June 28, 2001?
16 A The registration unit.
17 Q All right; and is that the same person
18 that would stamp it that would give it the control
19 number.
20 A I don't know exactly how the registration
21 unit works, so I'm not sure of that.
22 Q All right; so given the edict that
0929
1 anything about medical marijuana ought to go
2 directly to the Administrator, do you think that's
3 what happened in this case, that this application
4 just went to the Administrator's office and sat
5 there for a year?
6 A I don't know specifically, but I know
7 another reason why it wouldn't have been taken care
8 of. It's actually been filled out incompletely. I
9 don't know--or I won't say incompletely. I will
10 say incorrectly.
11 Q And what are you talking about?
12 A There's a process in the application where
13 manufacturers that wish to--bulk manufacture, in
14 this case, cultivate, when they note the drug code
15 that they wish to bulk manufacture, they're
16 actually supposed to list the four digit drug code
17 number and then circle it. So when this--I know it
18 seems like a mute [sic] point, but if they don't
19 circle it, it has a vastly different way that it's
20 processed within the office.
21 Q I'm sorry; can you tell me where you're at
22 in the schedule?
0930
1 A Yes, on page two--
2 Q The second page?
3 A Yes; subsection A, it says drug code
4 numbers. 7360 is marijuana. And then, under
5 manufacturer--
6 Q Yes.
7 A --there's some notations. It says bulk
8 manufacturer, synthesizer, extractor must circle
9 below those basic classes of controlled substances
10 in Schedule 1 or 2. The reason being for that is
11 because this initiates this infamous 303 process,
12 which is quite an extensive process.
13 Q Okay; and let me just ask you this: have
14 you talked to Sharon Lick, who was the registration
15 unit SC?
16 A I've spoken to her from time to time.
17 Q And did she ever tell you that this was
18 not acted on because the numbers were not circled?
19 A No, no, i've never asked, never inquired.
20 Q And you have no information that this
21 particular application was not acted on because the
22 numbers were not circled.
0931
1 A I wasn't in the registration unit at that
2 time.
3 Q And if they weren't scheduled and DEA saw
4 that and didn't want to act on it, would they
5 normally send it back to the applicant or let them
6 know somehow that they needed to be circled before
7 it could go forward?
8 A Well, it would be handled differently by
9 different folks, I would imagine. If headquarters
10 got it, I presume they could have sent it back to
11 him. If a field office received the application
12 for certain things that they're allowed to process,
13 I imagine they could have phoned, but I don't think
14 there's a specific protocol as to how they're to
15 respond.
16 Q But in any event, somebody at DEA would
17 have contacted the applicant and said there's this
18 problem?
19 MS. PAREDES: Objection, asked and
20 answered.
21 JUDGE BITTNER: No, I don't think it was.
22 Overruled.
0932
1 THE WITNESS: Presumably, yes.
2 BY MS. CARPENTER:
3 Q And to your knowledge, nobody ever
4 contacted Dr. Craker and said that was a problem
5 with this application; is that right?
6 A I can't answer that, because I wasn't
7 involved.
8 Q But to your knowledge, nobody did. Nobody
9 ever said to you, you know, the reason this hung
10 around for a year before we did anything was
11 because the numbers weren't circled.
12 MS. PAREDES: Objection, asked and
13 answered.
14 JUDGE BITTNER: No, it hasn't been.
15 MS. PAREDES: He said he wasn't involved.
16 THE WITNESS: To my knowledge, no.
17 MS. CARPENTER: Okay; thank you.
18 BY MS. CARPENTER:
19 Q Let's then to June 2002, which I think was
20 the first time you came to be familiar with this
21 application.
22 A October.
0933
1 Q I'm sorry?
2 A It was October.
3 Q October; I'm sorry.
4 JUDGE BITTNER: Could I just ask: am I
5 correct, Mr. Strait, that this application in
6 Government Exhibit No. 2 is a different format, the
7 form itself is a different form from that which
8 would be executed by a practitioner?
9 THE WITNESS: I think you may be correct,
10 because there's a 224 form and a 225. Does this--
11 JUDGE BITTNER: Okay.
12 THE WITNESS: Yes, this actually, if you
13 note, in Subsection A, applies to analytical labs,
14 distributors, importers, exporters, researchers and
15 manufacturers. I think our physicians and
16 osteopaths and them all get a different
17 application.
18 JUDGE BITTNER: Okay.
19 BY MS. CARPENTER:
20 Q Okay; just so I'm clear, I had thought on
21 direct you said you had a meeting in June 2002.
22 But it was October 2002.
0934
1 A The meeting that I referred was in June
2 2003.
3 Q Okay; so the first time you ever came into
4 contact with Dr. Craker's application was October
5 2002.
6 A Yes.
7 Q And that was when you became involved to
8 coordinate a response to this Covington and Burling
9 letter?
10 A Yes?
11 Q And can you tell me again who--I don't
12 think we ever got a list of who was at that meeting
13 where you were coordinating that response. Did you
14 say there was a meeting or--
15 A No, there was no meeting. This was more a
16 situation where the tasking came down to Frank
17 Sapienza, my supervisor at the time, and he
18 basically said, you know, please prepare a
19 response, and as normal, he would say see me, and I
20 would go and see him, and we would just kind of
21 verbally talk about things a bit, and then, he
22 would direct me to interact with chief counsel if
0935
1 necessary.
2 Q Okay; and in that conversation with Mr.
3 Sapienza, what did he say about the application, if
4 you recall?
5 A Well, I think at that time, Frank had
6 limited knowledge of the application as well,
7 because at that time, it wasn't handled by his
8 section. I don't know specifically if he made any
9 comments about the application.
10 Q Had he seen it at the time you had this
11 conversation, seen the application?
12 A Probably.
13 Q Okay; and I guess he had seen the answers
14 to the questions that DEA had asked.
15 A I can't say that for sure.
16 Q Had you seen those at the time you had
17 this meeting with Mr. Sapienza?
18 A I don't believe so.
19 Q So after you spoke to Mr. Sapienza, who
20 did you talk to?
21 A I spoke with two people.
22 Q Who else?
0936
1 A Which was himself and then a gentleman up
2 in chief counsel.
3 Q And who was that?
4 A A gentleman named Dan Dormont.
5 JUDGE BITTNER: When you say himself, you
6 mean Mr. Sapienza.
7 THE WITNESS: Yes.
8 BY MS. CARPENTER:
9 Q And what did Mr. Dormont tell you?
10 MS. PAREDES: Objection. Objection. It's
11 privileged communication. It's deliberative
12 process privilege as well.
13 JUDGE BITTNER: It's what? I'm sorry?
14 MS. PAREDES: Deliberative process
15 privilege.
16 JUDGE BITTNER: What's that?
17 MS. PAREDES: That's when an organization
18 or an agency is deciding on how to take official
19 action, and the communications that personnel
20 making those decisions have in arriving at a
21 decision are privileged, and they're deliberative
22 process.
0937
1 MS. CARPENTER: I believe that's a
2 privilege that applies to FOIA, but I don't believe
3 it's an evidentiary privilege that applies to court
4 testimony.
5 JUDGE BITTNER: I don't know. Can you
6 cite me anything?
7 MS. PAREDES: Not off the top of my head,
8 no.
9 JUDGE BITTNER: I think that is a FOIA
10 exemption.
11 MS. CARPENTER: I think it is.
12 JUDGE BITTNER: I do not purport to be an
13 expert on FOIA. I knew I didn't like this rule.
14 Mr. Strait, I'm trying to ascertain
15 whether or not there was a privilege without
16 getting into what Mr. Dormont said to you, which is
17 what I'm having a little difficulty with. Can you
18 just tell me the topics you discussed, not what was
19 said?
20 THE WITNESS: Yes.
21 JUDGE BITTNER: Okay.
22 THE WITNESS: We talked about whether or
0938
1 not the law firm was representing the applicant.
2 JUDGE BITTNER: Okay; I think that's
3 probably covered by the privilege of an attorney
4 within an agency discussing matters with an
5 employee of the agency about the employee's
6 official duties. So I will sustain the objection.
7 MS. CARPENTER: All right.
8 JUDGE BITTNER: But if you can cite me
9 something that says I'm wrong, I'll reconsider.
10 MS. CARPENTER: I don't think I can, Your
11 Honor.
12 JUDGE BITTNER: Okay.
13 BY MS. CARPENTER:
14 Q Let me just ask you one other question:
15 when you talked to Mr. Dormont, did anything of
16 what he told you get put into the letter that--the
17 responsive letter that was written?
18 A Yes.
19 Q Do you understand my question?
20 JUDGE BITTNER: We're still on Covington
21 and Burling, right?
22 THE WITNESS: Yes.
0939
1 BY MS. CARPENTER:
2 Q So some of what he told you went into the
3 letter that went back to Covington and Burling?
4 A Yes.
5 Q Okay; can you tell me what that was?
6 A Yes.
7 Q Will you do that?
8 A The part of the context of the letter
9 asked please provide us with information which
10 demonstrates that you represent the applicant.
11 Q Oh, I see.
12 A Before we decide whether or not we wish to
13 entertain the letter any further.
14 Q On its merits, as it were.
15 A Yes.
16 Q And is that all?
17 A Yes.
18 Q Mr. Strait, when you were involved in this
19 October time frame or anytime, did you ever see any
20 letters from any Members of Congress to the
21 Administrator or to anyone else with regard to Dr.
22 Craker's application?
0940
1 MS. PAREDES: Objection; outside the scope
2 of direct.
3 MS. CARPENTER: Your Honor, he testified
4 that he was coordinating the response to the letter
5 and that he then worked on the application and
6 talked with lots of people about it.
7 JUDGE BITTNER: Yes, I think what he--since he was
8 coordinating the response, I think
9 that's an appropriate question. Overruled.
10 THE WITNESS: I was one of the people who
11 were coordinating multiple responses, and I am
12 aware from viewing timelines that there were
13 certain pieces of correspondence that came in. At
14 that time, I was not privy to those. I became
15 aware, even though it didn't come to our section
16 for response of the Kerry-Kennedy letter, but
17 that's just about the only one.
18 BY MS. CARPENTER:
19 Q And are you aware what the concern was
20 that was raised in that letter?
21 A If I'm not mistaken, when that letter came
22 in, it was shortly after we received a letter from
0941
1 Dr. Doblin, and one of the comments that I had
2 noted when I read the letter from Kennedy and Kerry
3 that it seemed uniquely similar to the letter that
4 Dr. Doblin had prepared for us. And I actually had
5 wondered, and we had some discussions, as to
6 whether or not that information was provided to the
7 Senators themselves.
8 Q Okay; but can you tell me what the
9 concerns were that were articulated in those
10 letters is my question.
11 A Yes, I believe a comment about quality of
12 the marijuana, a comment about a government
13 sponsored monopoly; those seemed to be the things
14 that come back to my memory.
15 MS. CARPENTER: Just one moment, Your
16 Honor.
17 [Pause.]
18 MS. CARPENTER: If I could ask you to turn
19 in that book up there to Respondent's Exhibit No.
20 44.
21 MR. BAYLY: Sorry, what exhibit was that?
22 MS. CARPENTER: Respondent's Exhibit No.
0942
1 44.
2 BY MS. CARPENTER:
3 Q Have you found that, Mr. Strait?
4 A I have.
5 Q And is that the letter that you recall
6 seeing?
7 A Actually, it's not the letter I recall
8 seeing. I recall seeing one with signatures on it.
9 But it looks most likely similar in what was said.
10 I don't know line for line if it's exactly what the
11 incoming said.
12 Q Okay, and paragraph two, that paragraph
13 talks pretty much exclusively about under
14 adequately competitive conditions, doesn't it?
15 A Yes, there is a mention of 823(a)(1).
16 Q And also 21 C.F.R. 1301.33(b), a DEA
17 regulation, isn't that right?
18 A Yes.
19 Q Which also refers to the necessity for
20 adequately competitive conditions.
21 A Yes.
22 Q Okay; can you tell me, Mr. Strait, whether
0943
1 either this letter from Senator Kennedy or Senator
2 Kerry or another letter which I don't know if you
3 saw from five Massachusetts Congressmen, do you
4 know whether they played any role in the decision
5 of the agency in terms of granting the registration
6 or not granting the registration?
7 A Well, the decision by the administration
8 to grant or not grant certainly fell well above my
9 head.
10 Q I understand that.
11 A So I don't know whether or not these
12 pieces of correspondence had anything to do with
13 the response, the inevitable response.
14 Q Okay; and given that you did see this
15 letter at the time, was it a concern of you in
16 particular or DEA in general to determine whether
17 there were adequately competitive conditions in
18 manufacturers of bulk marijuana as you decided
19 whether or not to--
20 MS. PAREDES: Objection, outside the scope
21 of direct and lack of foundation. Calls for
22 speculation as to what DEA as an organization was
0944
1 going to do.
2 MS. CARPENTER: Again, I think he was
3 coordinating the response. I think he's rather
4 uniquely able to say what it is that he heard other
5 people talking about at the time.
6 MS. PAREDES: He's certainly not an expert
7 on competition.
8 MS. CARPENTER: That wasn't the question.
9 JUDGE BITTNER: Would you repeat the
10 question again, please?
11 MS. CARPENTER: Sure; could I ask the
12 Court Reporter to read that back?
13 JUDGE BITTNER: Oh, I hate to--
14 MS. CARPENTER: I'll do it, then. I'll do
15 it then.
16 COURT REPORTER: I can.
17 JUDGE BITTNER: All right.
18 [Whereupon, the reporter read back the
19 pending question.]
20 JUDGE BITTNER: Overruled.
21 THE WITNESS: Actually, I can't speak for
22 the Agency, but I will speak for myself to what
0945
1 extent that is helpful to you. And I actually
2 never saw competition as an issue, in that the
3 marijuana that is provided is on a cost
4 reimbursable basis. This is a not for profit
5 situation for the University of Mississippi, so
6 when the C.F.R. designates certain aspects that the
7 agency is supposed to consider when looking at
8 competition, they all seem to be geared around the
9 economics, and it's presumably the economics of
10 substances which are utilized in the legitimate
11 market for legitimate medicines.
12 This is a Schedule 1 substance which has
13 no legitimate medical use and therefore is used in
14 very limited quantities for basically scientific
15 research.
16 MS. CARPENTER: Okay.
17 BY MS. CARPENTER:
18 Q Well, it's also used for legitimate
19 medical research, isn't it?
20 A Legitimate research. I don't think we
21 designate between medical research or nonmedical
22 research.
0946
1 Q So if there are legitimate medical
2 research purposes going on, then, that would be an
3 area where competition under the statute would be
4 called for, wouldn't it?
5 MS. PAREDES: Objection; calls for
6 interpretation of the statute.
7 MS. CARPENTER: Well, he just interpreted
8 it.
9 JUDGE BITTNER: I didn't understand the
10 question.
11 MS. CARPENTER: Let me see if I can
12 rephrase it, Your Honor.
13 BY MS. CARPENTER:
14 Q You just testified that--as I understand
15 it you just testified that because it was a
16 Schedule 1 substance, there was no legitimate
17 purpose for it and therefore that competition
18 wasn't really an issue; is that right; is that
19 fair?
20 A No.
21 JUDGE BITTNER: No, I don't think that's
22 what the witness was saying. Maybe I
0947
1 misunderstood.
2 MS. CARPENTER: That's where I got
3 confused.
4 JUDGE BITTNER: What did you just say?
5 THE WITNESS: I'm not sure if that was a
6 correct characterization of what I said.
7 JUDGE BITTNER: Okay.
8 THE WITNESS: I think what I was getting
9 at was the fact that there are limited amounts of
10 Schedule 1 substances that are necessary to conduct
11 Schedule 1 research. There simply is just not a
12 lot that is required. So with that in mind, and
13 given the fact that a marijuana cultivator provides
14 marijuana to researchers at a not for profit basis,
15 I just didn't necessarily see the argument for
16 competition.
17 BY MS. CARPENTER:
18 Q Okay; so, you didn't ever consider
19 competition as you went through this process.
20 A Well, again--
21 Q You yourself, personally. I'm just
22 talking about you.
0948
1 A Me myself?
2 Q Right.
3 A Well, I should make sure for the record
4 it's clear that I have no decision in how the
5 Agency was going to come on this application, but
6 for me, if I were the person to make the decision,
7 I probably would have given less weight to the
8 competition argument.
9 Q And that's because there's not a lot
10 required, and so, there doesn't need to be
11 competition if there's not a lot required.
12 A That's not the primary reason. I'd say
13 the primary reason is that the University of
14 Mississippi provides it on a cost reimbursable
15 basis. So there's no profitmaking in this
16 situation. So the cost would be considered to be
17 much lower than the cost you would see for other
18 substances.
19 Q Okay; and if somebody else could provide
20 it for research on a--and their cost was much less,
21 and they were also able to provide it on a cost
22 basis, do you think that would be competition that
0949
1 the agency would consider?
2 A I've never seen that happen before, so I
3 don't know.
4 Q But if it were, would that be an issue
5 that you would have to consider?
6 MS. PAREDES: Objection, calls for
7 speculation.
8 JUDGE BITTNER: Yes, I think that's
9 getting kind of far afield.
10 MS. CARPENTER: Okay.
11 JUDGE BITTNER: Sustained.
12 MS. CARPENTER: All right.
13 BY MS. CARPENTER:
14 Q And let me just ask you one question: do
15 you make any recommendation as a result of your
16 investigation to approve or deny the license?
17 A No, actually. I do not make a
18 recommendation. I was responsible for drafting
19 decision paper for the deputy administrator to make
20 the decision.
21 Q So you drafted the decision paper that
22 presented both sides; is that--
0950
1 A I cowrote the decision paper along with
2 Ms. Kaupang.
3 Q And in that decision paper, there was no
4 recommendation one way or the other?
5 A No, absolutely not.
6 Q Okay; let me--I think you said in your
7 direct testimony that--I think this is a quote--that DEA had
8 problems with the application. I
9 think this was--when you were talking about one of
10 these early meetings in June 2002 when you were
11 coordinating the response. Could you tell me what
12 those problems were?
13 A If I'm recollecting what I was thinking at
14 the time, it may have been the incorrect way the
15 application was completed.
16 Q The lack of circles?
17 A Yes; that would be my guess as to what my
18 problem with the application.
19 Q And did anybody ever communicate that to
20 Dr. Craker.
21 A I don't know.
22 Q Is that still a problem with the
0951
1 application?
2 A No, we actually understand through his
3 response to the bulk manufacturing questions what
4 his intention was.
5 Q So the only problem as far as you knew in
6 2002, October 2002, the only problem DEA had with
7 the application was that the numbers were not
8 circled?
9 A I can't say that.
10 MS. PAREDES: Objection; the witness said
11 that was his problem, not DEA's.
12 JUDGE BITTNER: I'm not sure, but in any
13 event, the witness answered.
14 MS. PAREDES: Yes.
15 BY MS. CARPENTER:
16 Q At this coordination meeting you had, were
17 there problems with the application discussed?
18 JUDGE BITTNER: Are we talking about--I
19 want to get our meetings straight here.
20 MS. CARPENTER: I'm sorry.
21 JUDGE BITTNER: Are you talking about what
22 date, Ms. Carpenter?
0952
1 MS. CARPENTER: June 2003; sorry about
2 that.
3 THE WITNESS: Yes.
4 BY MS. CARPENTER:
5 Q Okay; that's the meeting where you had a--well,
6 tell me what happened in June 2003. Let's
7 just be clear about that.
8 A June 2003, the Drug and Chemical
9 Evaluation Section, Frank Sapienza's group, the
10 Drug Operations Group, which was Helen Kaupang's
11 group--
12 JUDGE BITTNER: Okay; now, wait a minute,
13 now, you're getting groups into the action.
14 [Laughter.]
15 THE WITNESS: I'm sorry; section,
16 sections.
17 JUDGE BITTNER: We were on sections,
18 units, divisions, and offices before.
19 THE WITNESS: Yes.
20 JUDGE BITTNER: Okay.
21 THE WITNESS: The Drug and Chemical
22 Evaluation Section, the Drug Operations Section,
0953
1 the Deputy Director of the Office of Diversion
2 Control, and the Office of Chief Counsel had gotten
3 together to decide a course of action on the
4 application.
5 BY MS. CARPENTER:
6 Q And what was the catalyst for this
7 meeting? What caused it?
8 A I think it was the application and the
9 incoming pieces of correspondence that had come in,
10 whether they were from the Senate, the House of
11 Representatives, Covington and Burling, DEA's,
12 Frank Sapienza's March 4 letter to Dr. Craker and
13 his subsequent response. Basically, I think it was
14 a coordination meeting.
15 Q Okay; so we're now two years after the
16 application was filed, and this is the first time
17 there has been a coordinated meeting about how to
18 respond to it?
19 A I don't know if there was anything the had
20 gone on in 2001 or early 2002, but this is the one
21 that sticks in my memory.
22 Q Okay; but you certainly weren't involved
0954
1 in any before this 2003 meeting.
2 A I was not.
3 Q Do you think you would be likely to have
4 been involved in one if there had been one?
5 A No.
6 Q Because of the reorganization?
7 A No, because in 2002, it really was, if
8 anyone got involved initially, it would have been
9 Frank Sapienza talking with other section chiefs,
10 but I wasn't privy to the conversation.
11 MS. CARPENTER: Okay.
12 JUDGE BITTNER: When did you become the
13 unit chief?
14 THE WITNESS: September 2004 in an acting
15 capacity and then actually officially this past
16 April.
17 JUDGE BITTNER: Okay; so what were you in
18 June 2003?
19 THE WITNESS: I was a drug science
20 specialist.
21 JUDGE BITTNER: In what unit?
22 THE WITNESS: No unit. We didn't have
0955
1 units at the time.
2 JUDGE BITTNER: Okay; the Drug and
3 Chemical Evaluation Section was just one whole--
4 THE WITNESS: We were unitless, yes.
5 JUDGE BITTNER: When did it get divided
6 into units, if you know?
7 THE WITNESS: September 2004, which was
8 when I took on the acting function.
9 JUDGE BITTNER: Okay; okay. Go ahead, Ms.
10 Carpenter.
11 MS. CARPENTER: I will. Thank you, Your
12 Honor.
13 BY MS. CARPENTER:
14 Q Is there a file that's kept with an
15 application, for example, that when different
16 actions are taken, they would all be in one file or
17 one place?
18 A I think in the best case scenario, yes,
19 but I don't think that's always the case.
20 Q Okay; do you know if there was such a file
21 in this case?
22 A I know we had a file, ODE, Drug and
0956
1 Chemical Evaluation Section had a file.
2 Q But you don't have any records that would
3 indicate that anything happened with regard to this
4 application in terms of formulating a response to
5 the application until June 2003?
6 A Well, no, I think there were some things
7 that had been going on prior to 2003 which, you
8 know, like I mentioned was Frank Sapienza's March 4
9 letter.
10 Q To Dr. Craker?
11 A To Dr. Craker, the Covington and Burling
12 response; I think could have been the Administrator
13 or one of his designees who responded to some of
14 these earlier letters to the House of
15 Representatives. But they weren't centrally
16 located. And so, therefore, I don't know.
17 Q And again, those were responding to
18 different letters to people but weren't actually on
19 the applications, were they?
20 A They weren't part of the application, no.
21 Q Okay; I think you also testified on direct
22 that you said given the problems we had with other
0957
1 agencies, we needed to be very careful about how we
2 handled the application. What did you mean by
3 that?
4 A I'm not sure if I recall the context.
5 Q I think it was Exhibit No. 29. I think it
6 was in the context of, if he could be handed
7 Government's Exhibit No. 29. That's in my notes,
8 but I think it may have been just before you
9 started talking about Exhibit No. 29, you said
10 this, and it was in the context, I think, of this
11 coordination meeting in June 2003.
12 A Okay.
13 Q When you first said the DEA had problems
14 with Dr. Craker's application.
15 A Right.
16 Q I think you identified the lack of the
17 circles and the numbers.
18 A Yes, there were other.
19 Q Oh, there were other problems as well.
20 A Absolutely.
21 Q And what were they?
22 A First of all, I would think the first
0958
1 problem that was noted to us or that we noted with
2 the application was that it represented the bulk
3 manufacturing of a Schedule 1 substance for the
4 development of a pharmaceutical product.
5 Q And how was that a problem with the
6 application if the application is authorized under
7 law?
8 A It's not a problem with the application
9 itself but what the application presented.
10 Q I see.
11 A And I think that it's not anything in
12 particular about the application, but it's probably
13 the same concern DEA would have if a company said
14 they wanted to develop heroin into a
15 pharmaceutically approved product. That was, I
16 think, one of the issues that was kind of a concern
17 to DEA about the application or what the
18 application presented.
19 Secondly, the other bulk manufacturers of
20 that drug class have opportunity to provide
21 comments to any notice of application published,
22 that being the University of Mississippi. I think
0959
1 we were kind of anticipating the fact that there
2 would probably be comments filed, and it could
3 potentially lead to a hearing, what we're sitting
4 in now, so I think we had concerns or a need to be
5 careful in how we proceeded with this.
6 Q I'm sorry; let me just interrupt you real
7 quick. Why would comments filed in response to a
8 notice lead to a hearing?
9 A Well, we have to consider the comments,
10 and if we don't have the information that's
11 necessary in order to accurately review the
12 comments, then, it's our obligation to go out and
13 make sure that we have the information that's
14 necessary in order to review the comments and put
15 the into perspective.
16 Q And how would that lead to a hearing?
17 A Well if DEA didn't feel that it had the
18 information it needed, it could always request a
19 hearing to try to obtain the information that it
20 needed, a public forum to obtain the information it
21 might need to further consider the application.
22 Q So DEA was anticipating at this time there
0960
1 might be a public hearing to gather information
2 relevant to this issue?
3 A I think DEA was anticipating that the
4 other bulk manufacturer of marijuana could provide
5 comments and that we needed to make sure we had
6 information that was going to be adequate to
7 address those comments.
8 Q I see, okay.
9 A With the idea that it inevitably could
10 lead to a hearing, sure.
11 Q Were there any other problems that DEA had
12 with the application?
13 A Yes, actually, there was a longstanding
14 history of the financier of the application, his
15 history was brought up in question at this meeting
16 and to the extent that we had concerns about the
17 financier's intention.
18 Q And who are we talking about when you say
19 the financier?
20 A MAPS.
21 Q MAPS? Okay.
22 A And specifically Dr. Doblin. There were
0961
1 concerns raised that he has an extensive what we
2 refer to as NADIS history.
3 Q NADIS?
4 A NADIS.
5 Q What is that?
6 A It's an internal database that the Agency
7 uses to track those individuals that--whose names
8 are either mentioned or who have been involved in
9 certain previous and ongoing cases, DEA cases.
10 Q So it tracks litigation against the
11 Agency?
12 A That's beyond me, but I don't know
13 specifically if it's litigation. I know it's more
14 of investigation type of thing, who we have ongoing
15 investigations with.
16 Q Okay; do you know what does NADIS stand
17 for?
18 A I do not.
19 Q And what was this discussion about this
20 longstanding history?
21 A Actually, it was really just a discussion
22 of the fact that Dr. Doblin does have a NADIS
0962
1 history, and we needed to consider that.
2 Q And when you say involved in ongoing
3 investigations, what does that mean?
4 A Well, actually--
5 Q An openly active investigation when you
6 were talking about it or a previous investigation?
7 A This would be the other side of DEA.
8 We're a regulatory group. So I can't say precisely
9 what that means. Perhaps other people in the
10 agency, some of our special agents and our
11 diversion investigators would probably know more
12 about what that means. I can't necessarily tell
13 you what that means.
14 Q Was there specific discussion about any
15 particular investigations of Dr. Doblin and whether
16 or not they had been resolved or not resolved?
17 A No, what I had understood was that the
18 Deputy Director, Terry Woodworth, had basically
19 asked one of his staff in a different section to
20 take a look at the NADIS history of Dr. Doblin and
21 to basically provide information as to what that
22 was. And it's my understanding that he received a
0963
1 report.
2 Q Did you ever see that report?
3 A I saw a previous version of it.
4 Q Previous to what?
5 A Previous to it's updated from time to
6 time, so--
7 Q And what did that report say?
8 A I don't know if I'm--first of all, I don't
9 really know if I can speak to some of it, because I
10 don't know to what extent it involved active
11 investigations, but also, I'm not even sure as to
12 its content. I don't think I could do a good job
13 of explaining its content.
14 Q Well, can you tell me what you remember
15 about what it said?
16 MS. PAREDES: Your Honor, we'd object at
17 this point to a law enforcement privilege as far as
18 ongoing investigations are concerned.
19 JUDGE BITTNER: Okay; are you representing
20 that there is an ongoing investigation?
21 MS. PAREDES: No, I'm not. I'm asserting
22 the privilege as far as any ongoing investigation
0964
1 as may or may not be happening.
2 JUDGE BITTNER: Okay; I think I need some
3 citation for this. I--
4 MS. CARPENTER: There certainly is--there
5 is an ongoing law enforcement investigation
6 privilege, at least in FOIA.
7 JUDGE BITTNER: But this isn't--
8 MS. CARPENTER: But not for closed.
9 JUDGE BITTNER: So when you're all talking
10 to the courts of appeals and the other courts and
11 the people who write the Federal Rules of Evidence,
12 would you please ask them to clarify this?
13 [Laughter.]
14 JUDGE BITTNER: I've gotten tangled up in
15 this much more than I want to be.
16 The question was what was in the NADIS
17 report; am I correct? What the witness saw in the
18 NADIS report.
19 MS. CARPENTER: Right. And if I can take
20 just one minute and--
21 JUDGE BITTNER: Yes.
22 MS. CARPENTER: While you think, could I--
0965
1 JUDGE BITTNER: Yes, let's go off the
2 record.
3 [Discussion off the record.]
4 JUDGE BITTNER: Counsel for Respondent has
5 just withdrawn her last question.
6 BY MS. CARPENTER:
7 Q Let me ask you this question: do you have
8 any knowledge about whether this NADIS report had
9 any bearing on the denial of Dr. Craker's
10 application?
11 A I can't answer that, because I wasn't
12 involved in making the decision.
13 Q Okay; that's fine. And the NADIS report
14 would be a private DEA report, DEA internal record.
15 A I know information in NADIS is considered
16 to be private, yes.
17 Q Okay; all right; so going back to the
18 discussion when I had originally started this with,
19 which you said given problems with other Agencies,
20 and this is right after you were talking about the
21 coordination meeting in June 2003. You said DEA
22 had problems with the application, and then, you
0966
1 said we had had problems with other agencies, and
2 we needed to be, quote, very careful about how we
3 handled this one, close quote.
4 A I don't really remember saying it within
5 that context.
6 Q Actually, you did, but you may not
7 remember what you were talking about. You don't
8 have any recollection?
9 A I don't have recollection of saying that.
10 Q You don't know problems with other
11 agencies that would have caused you to be careful
12 with this application or with an application?
13 A I'm questioning the term problem. I know
14 there is a lot of interaction that we have with
15 other agencies. So I'm not sure if I said problem.
16 Q Do you think you said something else?
17 A I don't recall.
18 Q All right; and I think you said that
19 Terry, and what was his last name? Is it him or
20 her?
21 A Him.
22 Q Is it Woodworth?
0967
1 A Yes.
2 Q So Mr. Woodworth directed you to go to
3 CMCR, HHS, NIDA, FDA, and other researchers with
4 Schedule 1 drugs to get an understanding of the
5 comments?
6 A Myself and Ms. Kaupang.
7 Q And Ms. Kaupang. Okay; and you told us
8 about going to CMCR. Did you talk to anybody at
9 CMCR that you haven't talked about on direct
10 examination? Did you talk to any other researchers
11 or administrators?
12 A Just those that were mentioned in each of
13 the questionnaires.
14 Q Okay; and what about HHS? Did you go to
15 anybody at HHS and talk to them?
16 A Yes.
17 Q Would that be NIDA? Because we'll get to
18 that in a minute.
19 A We met with Mr. Egertson, and then, we had
20 a phone conference at that same point with FDA.
21 Q And when you met with Mr. Egertson, what
22 did you talk about?
0968
1 A The PHS process.
2 Q Okay; and did you talk with him
3 specifically about Dr. Craker's application?
4 A Sure, putting it into the context of this
5 particular application that we received.
6 Q Okay; and did he have any comments about
7 Dr. Craker's application?
8 A I'm not sure if he knew about Dr. Craker's
9 application.
10 Q Well, I think you just said you told him
11 about it.
12 A Well, prior to us going there, I'm not
13 sure he knew that we had received an application.
14 Q Right, but after you told him about it,
15 did he make any comments about it?
16 A Oh, maybe; I don't recall if he made any
17 specific comments about it.
18 Q Was that the only person at HHS that you
19 talked with?
20 A Yes, that was there during that meeting
21 separate from FDA.
22 Q That was there at that meeting. Were
0969
1 there other meetings?
2 A No; I mean no other meetings other than
3 our NIDA meeting which is HHS.
4 Q HHS, right, and keeping that separate.
5 Okay; did you have reason to discuss an
6 application from Chemic with Mr. Egertson?
7 MS. PAREDES: Objection, outside the scope
8 of direct.
9 MS. CARPENTER: Your Honor, he testified
10 he talked--had these conversations with regard to
11 this particular application. I think anything that
12 went on in this conversation is--
13 JUDGE BITTNER: No, I think this is beyond
14 the scope. Sustained.
15 MS. CARPENTER: Okay.
16 BY MS. CARPENTER:
17 Q Whom did you speak with at the FDA?
18 A Those that were available via conference
19 call during our meeting with Mr. Egertson was
20 Sylvia Calderon--
21 Q Let me just be clear. So you met with Mr.
22 Egertson and the FDA at the same time?
0970
1 A Yes, FDA was on conference call.
2 MS. CARPENTER: I see.
3 JUDGE BITTNER: And I'm sorry, when was
4 this meeting?
5 THE WITNESS: This would have been the
6 January 2004 meeting, I believe, or was that our
7 NIDA meeting?
8 JUDGE BITTNER: I don't know; you're on
9 your own. You can't ask anybody.
10 THE WITNESS: I'm sorry; I'm confusing it
11 with our NIDA meeting. This was December--I want
12 to say 16th or 18th of 2003.
13 JUDGE BITTNER: Okay.
14 BY MS. CARPENTER:
15 Q So where was this meeting?
16 A At HHS headquarters.
17 Q Okay; and Mr. Egertson or Dr. Egertson, I
18 don't know which one he is, was there from HHS.
19 And then who was on the phone?
20 A Sylvia Calderon and a woman whose name is
21 Corinne Moody.
22 Q And did you tell them as well that there
0971
1 was an application from Dr. Craker submitted to be
2 a bulk manufacturer of marijuana?
3 A I assume that they probably were involved
4 and listened to any introductory remarks I did.
5 Q Do you recall if they had any response or
6 any comments on Dr. Craker's application?
7 A I don't recall specifically. Nothing that
8 comes to mind.
9 Q Do you recall if there was any discussion
10 at that meeting about licensing bulk manufacturers
11 in general of marijuana?
12 A I don't believe so. The application
13 process is not subject to their review, so I'm not
14 necessarily sure if we can ask them for information
15 or any comments they could provide to us.
16 Q Well, I'm not asking you if you asked for
17 it. I'm just asking you if they said anything.
18 A I would say no.
19 Q And then, turning to your CMCR meeting,
20 you said that Frank Sapienza had contacts out
21 there. Do you know who those contacts were?
22 A Drew Mattison was his primary contact.
0972
1 Q Do you know how he knew Dr. Mattison?
2 A Through various previous conversations
3 over the phone. Dr. Mattison had visited
4 Washington, D.C. on a number of occasions to talk
5 about the CMCR.
6 JUDGE BITTNER: And is it Madison as in
7 President Madison?
8 THE WITNESS: It's actually M-A-T-T-I-S-O-N.
9 BY MS. CARPENTER:
10 Q So had Dr. Mattison come to DEA to make
11 presentations about the CMCR?
12 A I don't recall. I know he had been to
13 HHS.
14 Q Do you know if Mr. Sapienza spoke with
15 anyone else at CMCR?
16 A Who? Did who speak to--
17 Q Did Mr. Sapienza?
18 A I think Frank actually knew Dr. Grant
19 fairly well.
20 Q Do you know how he knew him?
21 A No, not in particular.
22 JUDGE BITTNER: And this is Igor Grant?
0973
1 THE WITNESS: Yes.
2 BY MS. CARPENTER:
3 Q So how did it happen? Did Mr. Sapienza
4 call Dr. Mattison, or did you make the first
5 contact or who?
6 A No, actually, Frank requested that he make
7 the first contact.
8 Q Requested that he, Frank, make the first
9 contact.
10 A With Dr. Mattison, yes.
11 Q And do you know what he told Dr. Mattison
12 at that point?
13 A No, I don't; wasn't there.
14 Q How did you get involved in it?
15 A Shortly thereafter, I contacted Dr.
16 Mattison and introduced myself and proceeded to try
17 to organize a meeting.
18 Q And when you talked to the folks at CMCR
19 about setting up these meetings, what did you tell
20 them?
21 A What did I speak to to Dr. Mattison?
22 Q I assume you said you called him to set up
0974
1 the meeting.
2 A Mm-hmm.
3 Q Okay; what did you say to him?
4 A That we were evaluating an application,
5 and the applicant had made certain comments about
6 quality, quantity, potency and that we were out
7 there or wishing to go out there to interview the
8 PIs specifically to get their thoughts on those
9 issues.
10 Q Okay; and was there any conversation with
11 the folks at CMCR about getting information about
12 whether there was adequate competition within the
13 field, in the field of manufacturing of marijuana?
14 A Doubtful.
15 Q Not from you.
16 A Not from me, but I don't know why we would
17 interact with researchers around issues involving
18 competition.
19 Q Now, let me just ask you some questions
20 generally about the questionnaires that you all
21 developed. You had some conversations that were
0975
1 face to face, I think you said; is that right?
2 A Yes.
3 Q I don't recall who exactly, but why did
4 you fill out the interview forms instead of asking
5 them to fill them out while they talked with you
6 about the questions?
7 A I think it was more of a burden. We felt
8 that they were doing us a service to make
9 themselves available, to help us with one of our
10 administrative procedures, so if we gave it to them
11 and said hey, fill this out, I think they probably
12 would have been less likely or just would have said
13 you know what? I don't have the time for it. So
14 we said we'll take care of that part.
15 Q And were you pretty careful--I assume you
16 were pretty careful to write down everything that
17 people said.
18 A Yes.
19 Q Okay; you carefully wrote down all of
20 their comments.
21 A To the best of my ability.
22 Q And you testified about Dr. Grant giving
0976
1 an overview at the beginning of the meeting; this
2 was the meeting in September of 200--
3 A Three.
4 Q 2003. And he referred to a three-stage
5 research mission.
6 A Mm-hmm.
7 Q And he said that was CMCR's mission.
8 A Yes.
9 Q Did he say that was a mission that was
10 required by statute?
11 A No.
12 Q So it's not your understanding that that's
13 a mission required by statute.
14 A No, I think the statute just formed the
15 organization, and as the head of the organization,
16 I'm sure that he probably, interacting with other
17 folks came up with the vision instead of mission;
18 it was the vision of the CMCR.
19 Q Okay; let me just ask you: Dr. Grant
20 never said that CMCR intended to take smoked or
21 vaporized medical marijuana through the FDA
22 process, did he?
0977
1 A No.
2 Q In fact, he didn't say that they were
3 seeking to take any particular drug through the FDA
4 process of approval, did he?
5 A No.
6 Q Let me ask you to turn to Government's
7 Exhibit No. 18. Actually, Government's Exhibit No.
8 17; sorry about that. In that first paragraph
9 there of your introductory remarks, and I believe
10 you said that you wrote this; is that right?
11 A I did, yes.
12 Q And it says the DEA has heard that there
13 may be concerns amongst the marijuana research
14 community that if you spoke freely about the
15 marijuana that you received from NIDA that it could
16 result in your supply being cut off; is that
17 correct?
18 A That is what I've stated here.
19 Q And the place where you had heard that,
20 that was from the information you had gotten from
21 Dr. Craker; is that correct?
22 A The response from Dr. Craker to Frank's
0978
1 March 4, 2003, letter.
2 Q Okay; and Mr. Strait, are you familiar
3 with the Conant case?
4 A I am not.
5 Q Okay; are you familiar with a case in
6 California in which a doctor challenged a DEA
7 policy in which the DEA said that it would revoke
8 DEA license of any doctor who recommended
9 marijuana to a patient?
10 A I am not.
11 MS. PAREDES: Objection; relevance.
12 JUDGE BITTNER: Overruled.
13 BY MS. CARPENTER:
14 Q You're not familiar with that case?
15 A No, I'm not.
16 Q Let me represent to you that there was a
17 case called Conant v. Ashcroft, Ashcroft, maybe,
18 one of the--in which a doctor did challenge that
19 DEA policy. Assuming that to be the case, well,
20 let me rephrase that. If doctors were aware in
21 California of a DEA policy in which the DEA
22 threatened to revoke the DEA registration of any
0979
1 doctor who recommended marijuana, do you think
2 doctors who were aware of that policy might be
3 nervous about talking about marijuana with the DEA?
4 A Repeat that question for me one more time.
5 A Sure; assuming that there are doctors in
6 California that are aware of a DEA policy in which
7 the DEA said that it would revoke the DEA
8 registration of any physician who recommended
9 marijuana to a patient, would it be reasonable for
10 doctors in California to be a little nervous about
11 talking about marijuana with the DEA?
12 MS. PAREDES: Objection; calls for
13 speculation.
14 JUDGE BITTNER: I guess my bigger problem
15 with it is I don't think that what the witness
16 thinks makes any difference. No insult intended,
17 Mr. Strait, but Mr. Strait can think anything he
18 wants about this. I don't see how it accomplishes
19 anything. So I will sustain the objection.
20 MS. CARPENTER: That's fine, Your Honor.
21 BY MS. CARPENTER:
22 Q Mr. Strait, if you could turn in
0980
1 Government's Exhibit No. 17 to page 6, did you find
2 that page?
3 A Yes.
4 Q And question number 10 says is the potency
5 of the current product consistent. What's the
6 answer there?
7 A The answer is no, with a footnote.
8 Q Okay; and given that the answer is no,
9 would you consider that a complaint?
10 MS. PAREDES: Objection; relevance.
11 MS. CARPENTER: Well, Mister--
12 JUDGE BITTNER: Overruled.
13 THE WITNESS: I think it's an answer to a
14 question. Is it a complaint? I don't know.
15 BY MS. CARPENTER:
16 Q Well, you testified that you were looking
17 for whether there were complaints about the
18 marijuana, and that's the reason you designed the
19 questionnaire, right?
20 A We designed the questionnaire to address
21 three central issues brought up by the applicant,
22 yes.
0981
1 Q About quality, right?
2 A About quality, potency, and availability.
3 Q And that was a response to the assertion
4 by the applicant that there were complaints about
5 the quality, isn't that what you testified to on
6 direct?
7 A Sounds reasonable.
8 Q So if somebody says the potency of the
9 current product is not consistent, wouldn't that be
10 a complaint?
11 A I don't feel comfortable saying the word
12 complaint. It was an answer to a question, but the
13 comment that we got from--in followup to that was
14 that when the product did not meet a certain
15 potency, the University of Mississippi or NIDA was
16 actually very responsive.
17 Q But that's not actually what it says, is
18 it? It says at least two shipments, some
19 variability in stated THC and the actual measured.
20 They have been very responsive.
21 A Yes, that is what it actually says.
22 Q Yes.
0982
1 A They refers to NIDA or the University of
2 Mississippi.
3 Q Right.
4 A And actually trying to get a product back
5 to them, responsive in getting a product back to
6 them to fulfill their needs.
7 Q And is that what the researcher told you?
8 A Absolutely. That's--
9 Q But that's not written down here, is it?
10 A The comments I prepared on this
11 represented the answers by the researcher. So if I
12 said no with this footnote, then, this would have
13 been comments that the researcher provided to me.
14 Q But I'm just trying to get clear whether
15 there is stuff that the researchers told you that
16 you didn't write down, because now, you're telling
17 me the researcher said that NIDA or Mississippi
18 sent something back, and that's not written down
19 here. Do you just remember that now?
20 A No, I'm saying that that's exactly what is
21 inferred or if not stated--I don't know if I agree
22 with your assessment that it's not stated.
0983
1 Q It says they have been very responsive,
2 but we don't really know what responsive means
3 until you say they sent it back. I'm just trying
4 to get clear whether you wrote down everything that
5 they said or whether these are sort of your
6 interpretations of what they said.
7 A I wrote them down to the best of my
8 capability, and I gave each principal investigator
9 the opportunity; in fact, some of them took up to
10 three months to respond to my comments and to make
11 additions, deletions, whatever--
12 Q Right.
13 A --any modifications.
14 Q And nobody added anything here, right?
15 A No, nor did they delete it.
16 Q Right, but nobody explained what it meant
17 by very responsive I guess is my point.
18 A No.
19 Q Okay; but do you recall that that's what
20 they said, that NIDA had sent them a different
21 product?
22 A I recall that just simply what's in my
0984
1 statement here, that they, which is the NIDA and
2 the University of Mississippi, had been very
3 responsive in providing the material.
4 Q Ah, so that's the additional part. In
5 replacing the material or in providing the
6 material?
7 A Absolutely in replacing it, sure.
8 Q If you turn over to the next page, box
9 number 14, and the question was have any patients
10 ever complained about the freshness of the
11 marijuana, and what was the answer to that?
12 A The answer is yes.
13 Q Would you consider that a complaint?
14 A I consider it a response to the question.
15 Q What would you consider a complaint?
16 A I don't know if I was necessarily looking
17 for actual complaints from the people. It was
18 really just the completion of a questionnaire.
19 Q So you wouldn't say that there were
20 virtually no complaints from the researchers about
21 the quality of marijuana, would you?
22 A I would say that there were comments that
0985
1 were made regarding the availability, the potency
2 and the quality of product.
3 Q Okay; but would you say--
4 A Positive and negative.
5 Q But would you say that there were
6 virtually no complaints about the quality of NIDA
7 marijuana?
8 A Virtually no complaints? I don't know. I
9 can't answer your question. I'm not sure if I
10 could make that assumption.
11 Q Okay; if you look in the box under number
12 14, some patients have reported that the smoke--and
13 tell me if I'm reading this correctly--was, quote,
14 harsh, and it was hard to finish the cigarette. Is
15 that accurate?
16 A Yes.
17 Q And then, underneath that, it says
18 cannabis naive, and then, pts; is that short for
19 patients?
20 A Yes.
21 Q Are allowed, but most if not all are
22 experienced cannabis users.
0986
1 A Yes.
2 Q Okay; and then, under number 15, and the
3 question is have any of the issues discussed
4 regarding the quality of research grade marijuana
5 adversely affected your research? The answer is
6 no. And then, after that, could you read what that
7 is?
8 A It says hyphen one removed because of
9 cough only.
10 Q And what does that refer to?
11 A It would be in reference to one patient.
12 Q One patient removed from this particular
13 study?
14 A Yes.
15 Q Do you know how many patients were in this
16 study?
17 A It looks like 30.
18 Q Okay; and if you'd turn over to page 9,
19 box number 16.
20 A Yes.
21 Q Is that your writing out there to the
22 side, or is that somebody else's that says
0987
1 correction?
2 A No, that is Dr. Ellis'.
3 Q And that says 8 percent received but
4 tested potency was approximately 7 percent?
5 A Mm-hmm.
6 Q Okay; so does that refer back to the
7 variation in potency he was talking about?
8 A I would presume so.
9 Q There is no indication here that NIDA
10 replaced it, though, is there?
11 A Not based on his answer.
12 Q Comment right there; okay. And page no.
13 10, number 18, have you ever sought a higher
14 potency marijuana product; there's a yes there and
15 then struck out a no. Did the answer change, or
16 did you just write yes wrong the first time.
17 A The answer is no. I don't know the exact
18 situation as to why the patient or the doctor said
19 yes or if I incorrectly said yes.
20 Q All right; and then, the last page, page
21 12 of 12, when it says at the top have you had any
22 problems recruiting, not a problem with recruiting;
0988
1 a little slow, however; 9 or 10 of 30.
2 A Yes.
3 Q Does that indicate that at the time of
4 this interview that you only had 9 or 10 patients
5 enrolled?
6 A Nine or 10 enrolled, yes.
7 Q And one of those had dropped out?
8 A I'm not sure if the one is the difference
9 between the nine and the 10 that he's referring to.
10 I don't know if that is in fact the case.
11 Q But one of those nine or 10 had dropped
12 out; is that right?
13 A I'm not sure; I presume. I presume that
14 it may have been one of those 9 or 10 that had
15 subsequently dropped out, but I don't know if I can
16 say that as fact.
17 Q Okay; and I'm sorry to make you go back,
18 but back to no. 15, you were talking about one
19 patient removed, and it said because of cough only.
20 Do you recall what Dr. Ellis said about that?
21 JUDGE BITTNER: I don't you meant 15.
22 MS. CARPENTER: I'm sorry; question number
0989
1 15 on page 7.
2 JUDGE BITTNER: Okay.
3 MS. CARPENTER: I beg your pardon.
4 THE WITNESS: Yes, it really was in
5 reference, this is the catch-all question that
6 talks about quality, and there were four aspects
7 that the questionnaire got into, and it was visual
8 differences, deformities, plant parts and
9 freshness.
10 BY MS. CARPENTER:
11 Q Right, I'm just asking you what he meant
12 by one removed because of cough only.
13 A Yes, so really, what it means is in terms
14 of the four factors that we discussed with quality,
15 the cough, which is the harshness was the quality
16 aspect that was--that he was addressing.
17 Q So one patient was removed because of
18 cough related to the harshness of the marijuana.
19 A Yes.
20 Q Okay; If you'd turn over, Mr. Strait, to
21 Exhibit No. 18; that would be Government's Exhibit
22 No. 18. And again, this was the interview or the
0990
1 questionnaire with Dr. Corey-Bloom.
2 A Yes.
3 Q If you would turn to page 7 of 12, and in
4 box or question number 14, it says have any
5 patients ever complained about the freshness of the
6 marijuana, the answer is yes, isn't it?
7 A It is.
8 Q And then, just below that, it says
9 recently, one of 10 patients complained of the
10 product being harsh.
11 A Yes.
12 Q And then, underneath that, a note: didn't
13 explore what that means; don't know if it was
14 placebo or active. Does that mean that Dr. Corey-Bloom
15 didn't explore what that meant?
16 A Yes.
17 Q Okay; and let me ask you, this study with
18 Dr. Corey-Bloom, did NIDA provide both the placebo
19 and the active cigarettes?
20 A Yes.
21 Q That's what happened with all the studies?
22 A Absolutely.
0991
1 JUDGE BITTNER: Mr. Strait, I'm going to
2 show my ignorance again, I'm afraid. If you know,
3 in these studies, would a given patient always get
4 the same substance? In other words, he wouldn't
5 switch back and forth in patient X between the
6 placebo, the ditchweed or the marijuana?
7 THE WITNESS: It depends on the study
8 protocol design. There are certain types of
9 studies that are called crossover studies. If it
10 had a crossover design, it meant that the bias
11 introduced by different patients is removed,
12 because the patient takes one treatment, and then,
13 at some point, there is a washout period, and then,
14 there is another treatment, so that they actually
15 end up consuming over the study period both drugs,
16 but it is randomized as to which one they get first
17 and which one they get second.
18 JUDGE BITTNER: So if a patient is able to
19 distinguish between the placebo and the active, is
20 that what it's called?
21 THE WITNESS: Mm-hmm.
22 JUDGE BITTNER: Then, I guess what I'm
0992
1 thinking is if a patient always gets the same
2 stuff, the patient would be less likely to be able
3 to distinguish between them, because it wouldn't
4 see the others. But if you cross over, and they
5 are somewhat different in terms of how they feel,
6 how they look, how they smoke, you would know or
7 could know.
8 THE WITNESS: Presumably yes; if the
9 difference is great enough, then, they would be
10 able to.
11 JUDGE BITTNER: Okay.
12 BY MS. CARPENTER:
13 Q If you would turn to page 10 in
14 Government's Exhibit No. 18, and the first
15 paragraph there under benefit.
16 A Yes.
17 Q I'm going to read it, and you tell me if
18 I'm worthwhile. As a researcher, she would like to
19 explore the envelope of concentrations to evaluate
20 the, quote, more is better concept, close quote.
21 A Yes.
22 Q Did she say anything else about that that
0993
1 would explain what that means?
2 A I don't recall. This is the note that I
3 took from her comment, so I would say that this
4 represented fully what she said.
5 Q And did you ask her what she meant by
6 explore the envelope of concentrations?
7 A No.
8 Q And this was within the context of the
9 question do you think it--do you feel it would be
10 clinically important to evaluate the efficacy of a
11 higher potency cigarette for your patient
12 population, right?
13 A Yes, the question was represented within
14 that context.
15 Q So would explore the envelopes of
16 concentrations mean be interested in exploring
17 higher potency concentrations?
18 MS. PAREDES: Objection, calls for
19 speculation.
20 JUDGE BITTNER: Oh, I'm sorry; Ms.
21 Carpenter, can you reread what you read before?
22 MS. CARPENTER: Yes; it's just under the
0994
1 benefit section.
2 JUDGE BITTNER: Right; as a researcher she
3 would--
4 MS. CARPENTER: She would like to explore
5 the envelope of concentrations--
6 JUDGE BITTNER: Okay; okay.
7 MS. CARPENTER: --to evaluate the more is
8 better concept.
9 BY MS. CARPENTER:
10 Q And when you put the more is better
11 concept, you didn't ask her what she meant by that?
12 A I don't believe so.
13 Q Okay; did you understand what she meant by
14 that?
15 A I think I understand what she meant.
16 Q What does that mean?
17 A A lot of times, if a patient takes X,
18 then, in theory, if they take two times that X,
19 then, they should derive twice as much benefit.
20 Q Okay; so the notion was to explore higher
21 concentrations to--oh, I see, a higher
22 concentration of whatever the active ingredient is.
0995
1 A A higher concentration equates to the same
2 amount of inhalation, you know, an increased amount
3 of drug delivered. So if you introduce more drug,
4 then, see what kind of additional or not additional
5 benefit you derive from it.
6 Q Okay; and did she discuss at all the
7 notion that having more drug in terms of smoked
8 drug, getting more at one time would be better
9 because you would inhale less particulate or
10 carcinogenic matter? In other words, you would
11 have to smoke less to get the same amount?
12 A That comment was not made by Dr. Corey-Bloom.
13 Q Okay; was it made by anybody else?
14 A I believe so.
15 Q Do you recall who?
16 A No.
17 Q Okay; we'll get to that, I guess.
18 And then, underneath that, it says
19 further, and risk is slashed out. Does that mean
20 that this comment there does not relate to risk?
21 A Yes, it appears that I was separating the
0996
1 two comments and wanted to make it clear that this
2 comment was not fielded as a risk.
3 Q Very good notes. And could you just read
4 that? I was having a hard time figuring it out.
5 Maybe you could read that into the record.
6 A Further, even with one potency and one
7 inhalation procedure, there are different blood
8 levels, so perhaps there are other ways to get the
9 effect of more drug in the body just by the method
10 in which it is consumed.
11 Q Okay; and may I ask a question which I
12 concede is irrelevant? What is the one over the C?
13 Is that a medical--
14 A That's with.
15 Q With? Is that like a doctor's notation?
16 JUDGE BITTNER: Like cum? Is that where
17 it comes from?
18 THE WITNESS: Actually, my wife is a
19 physical therapist, and she uses it for with, so--
20 JUDGE BITTNER: Okay; yes.
21 THE WITNESS: So I assume nothing.
22 JUDGE BITTNER: Thank you.
0997
1 BY MS. CARPENTER:
2 Q In question number 19, on page 10 of 12,
3 in response to the question do you feel it would be
4 clinically important to evaluate the efficacy of a
5 higher potency cigarette for your patient
6 population, the answer is not in this particular
7 study but perhaps in a future study.
8 A Right.
9 Q No need for a higher potency product.
10 A Right.
11 Q Was it your understanding that her
12 response to that was saying I don't need it for
13 this study, but I might for another one?
14 A Yes, within this context, her protocol was
15 not approved for use of a higher potency product,
16 so it wasn't necessary for this study.
17 Q Okay; so, but her response to this
18 particular study wouldn't necessarily mean that her
19 response was that there was never going to be a
20 need for a higher potency product, would it?
21 A I think she says here that there is no
22 need for a higher potency product, but perhaps in a
0998
1 future study, maybe she's making an inclination
2 that she has an interest.
3 Q And you may not know this, but wouldn't it
4 make sense for a protocol, if a person is designing
5 a medical protocol for that to be designed to use
6 products that are then available?
7 MS. PAREDES: Objection; foundation; calls
8 for speculation.
9 JUDGE BITTNER: If the witness knows.
10 THE WITNESS: I'm not sure I can answer
11 that question.
12 JUDGE BITTNER: Okay.
13 MS. CARPENTER: Okay.
14 MS. CARPENTER: All right; let me ask you
15 to turn back to Exhibit No. 16, which I passed
16 over.
17 JUDGE BITTNER: You know what? I think
18 we're at--
19 MS. CARPENTER: Should we take a break?
20 JUDGE BITTNER: --a very good stopping
21 point.
22 MS. CARPENTER: Fine with me, Your Honor.
0999
1 I'm just trying to push on as long as you can stand
2 it.
3 JUDGE BITTNER: I know. I can see that.
4 Do you think you'll be able to finish your
5 cross tomorrow morning?
6 MS. CARPENTER: I think so, Your Honor.
7 JUDGE BITTNER: Okay; and we don't know
8 how long redirect will be; okay, so we'll see how
9 far we get. 9:00 tomorrow morning?
10 MS. CARPENTER: Yes, ma'am.
11 JUDGE BITTNER: Okay; off the record.
12 [Whereupon, at 4:41 p.m., the hearing was
13 recessed, to resume at 9:00 a.m. on Friday, August
14 26, 2005.]
15 - - -