[ Also see the Document Register ] 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 - - -