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 4   - - - - - - - - - - - - - - - x
 5   In the Matter of:             :
                                   :  Docket No. 05-16
 6   LYLE E. CRAKER, Ph.D.         :
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                              VOLUME IV
10                            Thursday, August 25, 2005
11                            DEA Headquarters
                              600 Army Navy Drive
12                            Hearing Room E-2103
13                            Arlington, Virginia
15             The hearing in the above-entitled matter
17   reconvened, pursuant to adjournment, at 9:05 a.m.
19   BEFORE:
21             MARY ELLEN BITTNER
22             Chief Administrative Law Judge
 2        On Behalf of the DEA:
 3             BRIAN BAYLY, ESQ.
               Office of Chief Counsel
 4             Drug Enforcement Administration
               Washington, D.C.  20537
               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
               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
18             MATTHEW STRAIT
19             Representative of the Government
21             Richard Doblin, Ph.D.
22             Representative of Respondent
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
 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
 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
 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
 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.
 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
 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
 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.
 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
 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
 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
 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
 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
 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
 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
 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.
 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
 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?
 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.
 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
 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.
 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
 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,
 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.
 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.
 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.
 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
 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
 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
 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?
 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
 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
 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:
 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
 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
 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
 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
 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
 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
 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.
 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.
 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
 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
 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.
 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
 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.
 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?
 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
 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.
 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.
 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
 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?
 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.
 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?
 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
 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
 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
 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.
 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. 
 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
 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. 
 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
 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.
 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.
 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
 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.
 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
 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
 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
 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
 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
 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
 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?
 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
 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
 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
 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
 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.
 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?
 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?
 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
 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
 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?
 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?
 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
 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
 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
 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.
 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.
 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.
 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.
 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.
 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
 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?
 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
 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
 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.
 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
 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?
 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,
 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
 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.
 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
 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.
 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
 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?
 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?
 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?
 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
 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.
 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.
 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.
 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.
 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.
 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.
 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?
 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,
 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.
 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
 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.
 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
 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
 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
 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
 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.
 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
 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
 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?
 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.
 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
 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.
 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?
 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
 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,
 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.
 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.]
 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
 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
 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?
 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
 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
 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
 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
 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
 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.
 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.
 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.
 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.
 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
 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?
 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
 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.
 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.
 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
 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.
 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
 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
 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
 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
 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. 
 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.
 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. 
 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
 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
 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
 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
 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
 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
 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?
 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
 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.
 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
 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
 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
 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?
 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.
 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.
 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.
 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.
 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
 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?
 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.
 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
 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.
 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?
 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
 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.
 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
 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
 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
 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.
 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
 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.
 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
 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--
 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
 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?
 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,
 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
 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
 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
 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
 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
 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
 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
 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
 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
 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
 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
 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--
 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
 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?
 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
 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?
 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
 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?
 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
 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.
 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?
 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
 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
 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
 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?
 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
 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
 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
 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.
 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.
 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.
 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
 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
 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.
 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
 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;
 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
 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
 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.
 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
 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
 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
 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.
 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
 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.
 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
 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. 
 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.]
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