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0170
1 UNITED STATES DEPARTMENT OF JUSTICE
2 DRUG ENFORCEMENT ADMINISTRATION
3
4 - - - - - - - - - - - - - - - x
:
5 In the Matter of: :
: Docket No. 05-16
6 LYLE E. CRAKER, Ph.D. :
:
7 - - - - - - - - - - - - - - - x
8 VOLUME II
9 Tuesday, August 23, 2005
10 DEA Headquarters
600 Army Navy Drive
11 Hearing Room E-2103
12 Arlington, Virginia
13
14
15 The hearing in the above-entitled matter
16
17 convened, pursuant to notice, at 9:00 a.m.
18
19 BEFORE:
20
21 MARY ELLEN BITTNER
22 Chief Administrative Law Judge
0171
1 APPEARANCES:
2 On Behalf of the DEA:
3 BRIAN BAYLY, ESQ.
Office of Chief Counsel
4 Drug Enforcement Administration
Washington, D.C. 20537
5
IMELDA L. PAREDES, ESQ.
6 Senior Attorney
Office of Chief Counsel
7 (202) 353-9676
8 CHARLES E. TRANT, ESQ.
Associate Chief Counsel
9 Office of Chief Counsel
(202) 307-8010
10
On Behalf of the Respondent:
11
JULIE M. CARPENTER, ESQ.
12 Jenner & Block LLP
601 13th Street, N.W.
13 Suite 1200 South
Washington, D.C. 20005
14 (202) 661-4810
15 M. ALLEN HOPPER, ESQ.
Senior Staff Attorney
16 Drug Reform Project
American Civil Liberties Union Foundation
17 1101 Pacific Avenue, Suite 333
Santa Cruz, California 95060
18 (831) 471-9000 Ext. 14
19 ALSO PRESENT:
20 MATTHEW STRAIT
Representative of the Government
21
Richard Doblin, Ph.D.
22 Representative of Respondent
0172
1 C O N T E N T S
2 WITNESS DIRECT CROSS REDIRECT RECROSS
3 Lyle E. Craker
By Mr. Trant 183 -- --
4 By Mr. Bayly 206 -- --
5 Barbara Roberts
By Ms. Carpenter 281 336
6 By Ms. Paredes 303 342
Further 343 344
7 Further 346 --
8 Lyle E. Craker
(resumed) -- -- 350 377
9 Further 390 --
10 John Vasconcellos 393 406 420 --
11 Dale Gieringer 422 444 452 463
12
- - -
13
E X H I B I T S
14
EXHIBIT NOS. MARKED RECEIVED
15
RESPONDENT'S
16
1 293 293
17
GOVERNMENT'S:
18
1 209 209
19
20 30 278 278
21
22 30A 372 372
0173
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. I have
3 here Respondent's Third Supplemental Prehearing
4 Statement and Motion for Relief to file it. Mr.
5 Bayly, have you had an opportunity to look at it?
6 MR. BAYLY: Yes, Judge Bittner, we did
7 have an opportunity yesterday afternoon when we got
8 it to look at and review it.
9 JUDGE BITTNER: And do you have any
10 objection to it?
11 MR. BAYLY: Yes.
12 JUDGE BITTNER: Okay.
13 MR. BAYLY: For the record.
14 JUDGE BITTNER: Okay.
15 MR. BAYLY: The motion indicates that Dr.
16 Doblin will testify instead of Mr. Alden, and
17 that's because Mr. Alden decided to take the Fifth
18 Amendment. And it is true what Dr. Doblin will
19 testify was placed in the prehearing statement
20 under Mr. Alden's proposed testimony way back in
21 June, but there are a couple of problems, major
22 problems here.
0174
1 First of all, this issue about giving Mr.
2 Alden immunity came up last week and, in fact, it
3 was just this past, I believe it was just this past
4 Friday that I talked to Mr. Alden's counsel, and
5 while I disagree with the characterization that the
6 Government, quote, "refused to give them immunity,"
7 I do want to point out that even if we had some
8 kind of obligation to do so, that obligation was
9 only brought to our attention last week even though
10 Mr. Alden's testimony was out there since I believe
11 the initial prehearing statement.
12 The motion also says that there won't be
13 prejudice to the Government. I would note that we
14 disagree with that characterization simply because
15 we can't cross-examine Mr. Alden. We have to do it
16 through Dr. Doblin, and I don't see how that's
17 possible.
18 I believe, Judge Bittner, you're aware of
19 21 CFR 1316.58(b). That's the rule that says if
20 you've got an affidavit, the affidavit may be
21 admissible, but you have to take into account the
22 fact that the opposing party would not have an
0175
1 opportunity to cross-examine.
2 Well, here we don't even have an
3 affidavit. We just have another witness who just
4 yesterday gave us notice that he's testifying as to
5 hearsay. So obviously we have no opportunity to
6 cross-examine Mr. Alden as we anticipated.
7 Lastly, our objection is based upon the
8 premise that I am totally unaware of any obligation
9 or requirement for the Government to give immunity
10 to a defense witness. Maybe defense counsels can
11 help us out here, but I don't know of any
12 obligation or requirement. If there were any, then
13 this motion might have some merit if it weren't
14 belatedly asserted, but to explain the procedure on
15 this, Judge Bittner, there are a number of statutes
16 which guide prosecutors in giving witnesses--that
17 is Government witnesses--immunity.
18 And of course, it has to be through
19 statute, and we do have an immunity procedure here
20 at DEA. The procedure would be to--it's found--let
21 me give the cite--it's found at 28 CFR 0.175, and
22 the procedure would be to request of the
0176
1 Administrator to give a witness immunity, and the
2 Administrator couldn't unilaterally give a witness
3 immunity without consulting with the Criminal
4 Division of the Department of Justice.
5 And again, I'm totally at a loss to know
6 what kind of a procedure we would do to do this for
7 defense witnesses. I mean I'm Government counsel
8 and theoretically if there were a witness that I
9 wanted to put up there, but I wanted to give the
10 witness immunity, I would request that the
11 Administrator in consultation with the Criminal
12 Division please allow this witness immunity, and
13 they may say fine; they may say, Bayly, you're
14 nuts; get out of here.
15 I don't know if--this is totally
16 unprecedented to me, so I don't know if perhaps
17 even Defense counsel could request from the
18 Administrator. I don't even know if we as counsel
19 or DEA Chief Counsel here, if we'd have the
20 obligation to do it. I just don't know. Like I
21 said, I don't believe there's a legal duty or
22 obligation for us to do this.
0177
1 So for those reasons, I think we would
2 oppose this motion at this time.
3 JUDGE BITTNER: Okay. Ms. Carpenter,
4 would you like to respond?
5 MS. CARPENTER: Thank you, Your Honor.
6 Mr. Bayly is entirely correct in his
7 characterization of the timing. It did come up
8 last week. The reason it came up is because it
9 hadn't occurred to any of us that it would be an
10 issue. The witness who we don't represent
11 obviously talked to his lawyer, and his lawyer
12 said, you know--talked to him about this testimony,
13 and didn't call him until a week or so before, and
14 said this is what I'm going to say, and he said do
15 you realize that there, although it seems remote,
16 there is some possibility that the DEA could come
17 after you for talking about your marijuana use as
18 medical marijuana use.
19 The witness said what can we do about
20 that? As I understand it, counsel contacted the
21 Government to see if they would give immunity. I
22 am not a defense lawyer. I don't know whether
0178
1 there is any obligation, but I'm not sure that
2 that's determinative of the question here.
3 We did ask the Government and they did
4 refuse. So I think that characterization is clear.
5 They would not give immunity regardless of whether
6 they had an obligation. In terms of prejudice to
7 the Government, it is true that they can't cross-examine Mr.
8 Alden, but it is also true that the
9 rules specifically allow hearsay testimony to come
10 in.
11 We're not able to cross-examine all the
12 investigators whose interviews Mr. Strait is going
13 to talk about later during the Government's case.
14 We can't put them on the stand to talk about
15 whether what he characterizes them as saying is
16 accurate or not. That's just a facet of hearsay
17 testimony that's inescapable in the context of an
18 administrative law hearing.
19 So we would argue we're doing the best we
20 can, I guess is our argument. We have a witness
21 who is in some jeopardy of criminal prosecution and
22 who is legitimately concerned about that. We think
0179
1 it's important testimony given that the rules
2 specifically allow hearsay testimony to be
3 admitted, given that Dr. Doblin has talked directly
4 to this particular witness and can say exactly what
5 was in the prehearing statement, and that the
6 Government has had plenty of time to prepare to
7 address that in any way that they see fit.
8 There doesn't seem to me to be any more
9 prejudice to them than that which goes to us from
10 not being able to put somebody on because we're in
11 front of the DEA.
12 JUDGE BITTNER: You know I spent all that
13 time in law school learning the hearsay rule. Fat
14 lot of good it did.
15 [Laughter.]
16 JUDGE BITTNER: Okay. It seems to me that
17 this whole question of immunity and obligation or
18 lack of obligation to grant it is something of a
19 red herring because the only difference between the
20 situation we have today and the situation we would
21 have had if Respondent had initially listed this
22 evidence under Dr. Doblin's testimony is that the
0180
1 issue arose last week. So the Government was
2 assuming correctly that it--appropriately I should
3 say--that it would have the opportunity to cross-examine the
4 witness and now it doesn't.
5 But I have said I don't know how many
6 hundreds of times that hearsay is admissible.
7 Everybody is agreed on that whether we like it or
8 not, and that the hearsay nature of testimony is
9 something that I consider when I weigh the
10 evidence, and I think that's what applies here.
11 So I will overrule the objection, consider
12 Respondent's Third Supplemental Prehearing
13 Statement as properly filed, and therefore I will
14 allow Dr. Doblin to testify as recited therein.
15 But, of course, I will also keep very much
16 in mind that this is hearsay and that the
17 Government is put at "x" amount of disadvantage--and I don't
18 know how to quantify "x" at this point.
19 It may be zero. It may be a positive number. I
20 don't know--by finding this out yesterday instead
21 of earlier. So that's the ruling.
22 Okay. Anything else before we cross-examine Dr.
0181
1 Craker or is that not what we're doing
2 this morning?
3 MR. BAYLY: Your Honor, we do have one
4 request, and Mr. Trant has entered an appearance
5 here.
6 JUDGE BITTNER: Right.
7 MR. BAYLY: And he would start the cross-
8 examination of Dr. Craker, only limited to the
9 questions pertaining to how the witness goes about
10 making, growing, cultivating marijuana, and how
11 that would apply to 823(a)(3) and then that would
12 be limited to where he would cross, and then I
13 would pick it up and move on.
14 JUDGE BITTNER: Any objection, Ms.
15 Carpenter?
16 MS. CARPENTER: I guess not. It's a
17 little unusual.
18 JUDGE BITTNER: Mr. Hopper wants to jump
19 into the act here.
20 MS. CARPENTER: I guess I would ask for
21 similar retroactivity if it becomes necessary to
22 split the cross between us for some reason down the
0182
1 line for your witnesses.
2 MR. BAYLY: You mean reciprocity?
3 MS. CARPENTER: Reciprocity.
4 [Laughter.]
5 JUDGE BITTNER: I like retroactivity
6 better.
7 MS. CARPENTER: I'm feeling a little
8 nuclear this morning.
9 [Laughter.]
10 JUDGE BITTNER: I think, yeah, that would
11 be appropriate. I mean normally I don't allow
12 that, but I think it's safe to say that Dr. Craker
13 is not an unsophisticated witness. So I'll allow
14 it.
15 MR. BAYLY: Yeah, certainly. I mean
16 reciprocity is understandable, and we'd certainly
17 agree with that.
18 JUDGE BITTNER: Okay.
19 MS. CARPENTER: Or retroactivity.
20 [Laughter.]
21 MR. BAYLY: We don't plan to do this as
22 far as I know any other time, but if Defense
0183
1 counsel want to have that arrangement, that's fine.
2 JUDGE BITTNER: Okay.
3 MR. BAYLY: What's good for the goose--
4 JUDGE BITTNER: Dr. Craker, would you
5 please resume the stand now that we've been talking
6 about you. And I'd like to remind you that you're
7 still under oath.
8 DR. CRAKER: Thank you.
9 Whereupon,
10 LYLE E. CRAKER, PH.D.
11 was recalled as a witness herein and, having been
12 previously duly sworn by the Administrative Law
13 Judge, was examined and testified as follows:
14 CROSS-EXAMINATION
15 BY MR. TRANT:
16 Q Good morning. Thank you, Your Honor. Dr.
17 Craker, the reason we're doing this so that you're
18 not in any state of confusion is because it's very
19 important for the Government--
20 JUDGE BITTNER: Hold on, Mr. Trant. We're
21 having this microphone fight again. Off the
22 record.
0184
1 [Off the record.]
2 JUDGE BITTNER: Back on the record.
3 BY MR. TRANT:
4 Q Dr. Craker, the only area that I want to
5 go into is the actual processes that you follow
6 when growing marijuana, and the reason is that it's
7 very important that when the time comes for the
8 Deputy Administrator to make her decision that she
9 have a complete factual record in terms of what it
10 is that you do. She may be a lot like me. I mean
11 I could have been useful in some of your defoliant
12 studies. I walk near a plant; it dies.
13 So I would probably need a Gardening 101
14 course, and that's all I'm really attempting to
15 establish at this point, just so it's very clear in
16 the record exactly how this process occurs. We may
17 think of it like growing a tomato plant, you put it
18 in a little dixie cup, and somewhere down the road
19 you transplant it to your garden, and ultimately if
20 the deer don't get at it, you have tomatoes at the
21 end of the season.
22 So would you tell me initially how would
0185
1 you initiate the process? Does it involve like a
2 seed selection? You actually select the seeds that
3 you would want to use in order to start the
4 germination process?
5 A Yes, once we have located a seed source
6 and have permission to import seeds or get seeds
7 that we could use, then we would want to--I mean
8 the normal procedure would be similar to what we
9 use with other plants, your tomatoes included. We
10 would place them in a growth media which growth--
11 Q For want of a better term, that's soil or
12 some type of soil?
13 A No, that would not be soil. We generally
14 don't grow plants in soil because the soil becomes
15 compacted as they're watered. We use a mixture of
16 generally a greenhouse mix they call them, and
17 there are various ones on the market. They usually
18 consist of perlite, vermiculite and peat moss.
19 Q These substances are ones you'd use in
20 virtually then any plant type of growth?
21 A In any plant, any greenhouse plant.
22 Q Just kind of a standard--
0186
1 A Yes. The ratio may change. There's
2 usually lime added to neutralize the acidity of the
3 mixture, and there is usually starter fertilizer in
4 there of some kind, nitrogen, phosphorus and
5 potassium, in order to give the germinating seed a
6 boost, nutritional boost, as it attempts to emerge.
7 Q And these are all commercially available
8 products that you've used in the past and would
9 anticipate using in this project?
10 A Well, I don't know what you're--commercial
11 products?
12 Q Well, I mean you buy--I assume you buy
13 them from somewhere?
14 A The media?
15 Q The media.
16 A Well, at the university, I try not to buy
17 too many things. I like to have donations.
18 [Laughter.]
19 BY MR. TRANT:
20 Q I'm sorry.
21 A The media, generally we use media that's
22 donated to us. We on occasion need to mix our own
0187
1 media because again most commercial media comes
2 with a starter fertilizer, and in some situations
3 where we're looking at a specific nutrient
4 deficiency, we may very well buy the ingredients
5 and mix them ourselves in a cement mixer.
6 Q But this is a process you've used in the
7 past--
8 A Yes.
9 Q --in terms of securing this type of media
10 and then testing it out in order to develop it to
11 the point where it's exactly the type of media that
12 you would want to use for the type of plant that
13 you're seeking to cultivate?
14 A Testing it out I don't quite understand
15 there. I mean commercial media usually is
16 satisfactory for everything we're going to do.
17 Q You said you might have to test. It may
18 need more phosphorus.
19 A Oh, yes, if we need--
20 Q In some way or other make certain it has
21 all the nutrients in it that you want.
22 A Some way, yes. Yes.
0188
1 Q That's the testing process. And then when
2 you secure the seeds, what would you do in order to
3 determine the seeds are acceptable in terms of
4 they--that they are, I guess, fertile seeds or
5 viable seeds or capable of growing or--
6 A Well, hopefully, the source of seed supply
7 will be able to tell us the percent germination of
8 those seeds. The general procedure is to overplant
9 the number of seedlings needed in a greenhouse
10 flat, and then one selects out the most vigorous
11 growing seedlings and places them into a larger
12 container, as we develop the plant towards
13 maturity.
14 Q Okay. And this is a standard methodology?
15 A It's a standard methodology used.
16 Q It's the same methodology you would use in
17 this project?
18 A Same methodology I use with many medicinal
19 plants.
20 Q And in terms of the seeds, now at some
21 point down the road, if you were cultivating a
22 plant like marijuana that actually has seeds, will
0189
1 you secure any of the seeds from those plants for
2 later use so you wouldn't have to purchase them
3 from somewhere else or you would have more control
4 over the supply of seeds that you've been using for
5 future generations of plants?
6 A I think to some extent that depends upon
7 the source of seeds, and I'm not sure about the
8 legal ramifications of that. We would certainly
9 want to go according to any of the instructions
10 from the Drug Enforcement Administration on the
11 ability to keep our own seeds or not. That's not
12 something I'm anxious about doing, especially as
13 the initial studies get underway.
14 We'd rather get the seeds, a seed source,
15 and get our seeds there, yes.
16 Q Yeah. Initially. But then assuming that
17 was permissible practice there to just, you know,
18 collect some of the seeds, then you wouldn't have
19 to worry about having them donated or securing them
20 elsewhere. You'd basically have your own ready--
21 A That's a possibility.
22 Q --recurring supply?
0190
1 A That's a possibility.
2 Q So then you don't actually then test the
3 seeds for their viability. You do that by planting
4 enough and so long as they come in from a reputable
5 source, they will presumably grow a sufficient
6 number of plants for your purposes?
7 A That would be the procedure, yes.
8 Q And then initially, I mean I've described
9 this kind of little dixie cup approach, you know,
10 when you start off, you take the little dixie cup,
11 you have the thing germinate, then move it to a
12 bigger pot and ultimately to a garden?
13 A Yes.
14 Q Is that essentially the process that you'd
15 be following here, when they first start to
16 germinate, you move them from one container to a
17 larger container or?
18 A Well, the answer to that is yes, only your
19 initial container is usually a flat which has
20 several, maybe several hundred seedlings in it when
21 we start out, not a dixie cup.
22 Q Okay.
0191
1 A But they'd be essentially transplanted
2 that way, yes.
3 Q Okay. A flat tray so the media level
4 would be--
5 A They're standard trays.
6 Q --filled in?
7 A They're standard trays and there are
8 standard trays in the tray.
9 Q And these are the type of standard
10 equipment that's available that you've used in the
11 past?
12 A Yes.
13 Q And would use in the future?
14 A Use them. Use them all the time.
15 Q Okay. And then when they're then
16 transplanted, what type of container are they
17 transplanted to initially from the flat container?
18 A I'm sorry? I didn't--
19 Q What would be the next? Initially they
20 germinate on this flat container.
21 A Yes.
22 Q Then they're moved to--what's the next
0192
1 container?
2 A Well, generally, it would depend upon the
3 size of the seedling because you have to match the
4 pot size essentially to the seedling so that you
5 don't rot the roots off with too much water being
6 accumulated and that. So I mean it could be--it
7 could be a three-inch diameter pot, a four-inch
8 diameter pot, or if the seedlings are growing very
9 vigorously, it could be a six-inch diameter pot.
10 But there would probably be--there probably would
11 be in the case of marijuana, which I have no
12 experience in growing, I would suggest we would
13 probably germinate them in flats, probably move
14 the, transplant the seedlings into three-inch or
15 four-inch diameter pots and then transplant them
16 into larger pots for final growth.
17 Q And these are--this is the process you've
18 followed with other plants?
19 A The process we follow with other plants.
20 Q And the types of containers are standard
21 flower pot type?
22 A Standard greenhouse plastic pots that we
0193
1 purchase by--they don't donate those. We have to
2 purchase those.
3 Q And in terms of the growing process, are
4 there any special nutrients, chemicals,
5 fertilizers, you would use or are these--
6 A These are--
7 Q The combination may vary, but they're
8 basically, and again--
9 A They are standards.
10 Q I'm definitely Gardening 101. Is there
11 some standard fertilizer that you would use?
12 A We use a commercially available
13 fertilizer. It's usually 10-10-10, which means ten
14 parts nitrogen, ten parts phosphorus and ten parts
15 potassium.
16 Q So this is not any type of new fertilizer
17 that you'd have to develop specifically to grow
18 these type of plants?
19 A Not that I'm aware of, no.
20 Q And then--I'm sorry.
21 A If special nutrient deficiencies were
22 noticed, then I suspect we would have to add
0194
1 something else, but I don't foresee that.
2 Q So you would then--the plants then just
3 grow given the, I guess, the adequate nurturing,
4 the skills that I'm incapable of?
5 A They're going to need, I assume like all
6 plants they're going to need light and they're
7 going to need water, and I think then they would
8 grow.
9 Q Okay. And all these you anticipate will
10 be grown in a greenhouse environment?
11 A Well--
12 Q That may be the wrong term, and again I
13 apologize if I--
14 A No, that's okay.
15 Q --if I used the inappropriate terminology.
16 A I think where they'll be grown depends
17 upon the security arrangements that are needed.
18 What I have talked with DEA agents who visited my,
19 our campus, we have spoken about an enclosed room
20 with--they wanted one wall against the, buried by
21 earth so nobody could drill through from the
22 outside. We have such a room, and it's an enclosed
0195
1 room. I mean it has one door in and one door out.
2 Q Now you anticipate that they would come to
3 their final maturity there while still in a potted
4 environment as opposed to an in-ground environment
5 or?
6 A I think that would not be to--we could use
7 larger pots to grow those in, yes.
8 Q And at a certain point you would determine
9 that the plant is fully grown, ready for
10 harvesting?
11 A Yes. There would be some point in the
12 development where they want to be harvested.
13 Q Okay. And what determination would go
14 into deciding the plant is ready for harvesting?
15 Is it size or it's something about its ostensible
16 maturity or?
17 A I assume it would be the maturity,
18 depending on the type, the part of the plant that
19 we wanted to harvest. If leaves, you could get
20 almost immediately, but if you want to harvest, if
21 you want to harvest flower buds, you'd have to wait
22 until they appear.
0196
1 Q And then when you harvested it, it then
2 goes to a drying process of some kind? Would that
3 be the next step in the process?
4 A That would be, if people wanted dry
5 material, which I assume that everybody would, the
6 material would need to be dried, yes.
7 Q And what does the drying process entail?
8 A Well, we have, again, commercially
9 available drying ovens which we dry other plant
10 material in. We would probably dry them somewhere
11 around I would suspect about 40 degrees Centigrade.
12 That's usually for medicinal plants is where
13 material is dried, unless there's available
14 literature that suggests another drying temperature
15 and to remove, and they would be dried down to a
16 low enough moisture content so that we would not
17 have to worry about fungal growth then.
18 Q And these are ovens that you already
19 possess or are at your facility?
20 A Well, we have drying ovens. The drying
21 ovens we have available are quite large and they
22 would not be suitable for this, the material,
0197
1 because they would not--I cannot secure those. We
2 have to buy a new drying oven that would go in.
3 Q But the drying oven--
4 A But these are commercially available.
5 Q The drying oven is already commercially
6 available?
7 A Yes.
8 Q But it would just be a smaller volume one
9 than the ones you have?
10 A A smaller volume, yes. The one we have is
11 probably--I don't know--maybe eight feet by eight
12 feet by ten feet high with a lot of shelves in it.
13 I'm not going to move that into a small room.
14 Q But the process that you use would be
15 identical to using the smaller ovens as processes
16 you've used in the past with the larger oven?
17 A That's true.
18 Q So it would then result in the same
19 methodology would be used?
20 A The same methodology would be used, yes.
21 Q Now, you had indicated that you could grow
22 this to specification basically. At what point
0198
1 does that determination have to be made? Is it
2 from the seeds? Is it while the plant is growing?
3 Is it after it's grown? At what point would you
4 determine that you've met the specifications in
5 terms of growing the plant?
6 A Well, I think that needs to--I think the
7 only time you really know whether you're made the
8 specification or not is after you've harvested and
9 the material has been tested. Certainly I can't
10 tell from the seed or the seedling. What the seed
11 can do is give us an estimate of where we're going
12 to be.
13 Q So would you then--say, for example, if
14 you wanted a certain percentage of THC component in
15 there, and when you finished the process, it wasn't
16 where you wanted, would you go through some
17 selection process to then cross-germinating these
18 things in order to take the highest ones and
19 somehow keep boosting it up until your final
20 product reaches your specification?
21 A That would be one way of approaching the
22 problem, and one is not going to do a lot of that
0199
1 in the time we've asked for the license. That
2 would have to be an extended time.
3 Q I guess this is probably what--
4 A Yes.
5 Q --I'm trying to understand is if you get a
6 request in that we want, that the researcher wants
7 a certain product with certain specifications,
8 other than the hope that the plants that happen to
9 be selected because they were the most vigorously
10 germinating plants end up at that level, is there
11 any other way you would manipulate the process
12 during the growth of the plant in order to try to
13 get to specification?
14 A Yes, from--there are some possibilities
15 from the literature, scientific literature that I
16 have read about. Scientific and unscientific
17 literature I guess I would have to say in--
18 Q There are many unscientific growers of
19 marijuana.
20 A Yes, scientific growers of marijuana--which they
21 indicate that various light regimes can
22 influence the THC content. They indicate that
0200
1 various manipulations of plant material, pruning,
2 growing all female plants. There are--I have not
3 looked into those at depth because--
4 Q But there are existing techniques out
5 there that you can try?
6 A There are techniques that we would try.
7 Q And so that you could then be able to do
8 it. And at the end of the process when you have
9 your dried product, how would you go about
10 determining what the THC content is, for example?
11 A Well, again, we have not had experience in
12 that, but those techniques are available, and one
13 would have to run the appropriate type of test
14 using the appropriate instruments, laboratory
15 instruments.
16 Q Okay. But all that technology is
17 available for actual--
18 A The technology is available there, yes.
19 Q Okay. And do you think that you would be
20 performing that function there or having someone
21 else, an analytical lab test it out, or who would
22 make the determination prior to sending it off to
0201
1 the researcher who has requested it? I assume
2 you'd want to test it out to see if it meets their
3 requirements? You would have it tested to make the
4 determination?
5 A Well, I think that could go either way. I
6 don't think it's--I think we're some distance away
7 from making a decision like that. I think either
8 is possible. For example, if I get a sample of
9 material to--I was going to use a sample material--the
10 receiving end would certainly want to confirm
11 what they have and that may be enough that we don't
12 need to test it.
13 We could simply say this has been grown
14 from seed that's supposed to have this THC content.
15 We've done the following things to ensure that.
16 Here's your sample and you had better test it
17 before you use it.
18 Q Okay. Or you could maybe subcontract with
19 someone else to test it so that if the researcher
20 says I don't want to have to test--I want to
21 receive a product that meets my specifications as
22 opposed to here's a product, you test it out and
0202
1 maybe it will meet the specs, maybe it won't,
2 wouldn't they prefer to have it already pretested
3 to make certain that--
4 A Well, that's a possibility, and I assume
5 that if there was a DEA approved laboratory where
6 this could be tested, we could send samples there
7 for testing.
8 Q Okay. To an analytical lab I think would
9 be the type--
10 A An analytical laboratory of some type,
11 yes.
12 Q But again that's a process that already
13 exists and there are people out there--
14 A There certainly are laboratories that--
15 Q Who are capable of doing that?
16 A Capable of doing this.
17 Q Okay. So if that were a requirement for
18 this process to move forward, that would be done
19 through that method?
20 A A former colleague of mine does that for
21 the state police in Massachusetts all the time.
22 Q And you had mentioned something about
0203
1 this, I guess this smaller container. I forget.
2 Sounded like a metal box where you can really--
3 A It's a plastic box.
4 Q It's a plastic box.
5 A Yeah.
6 Q Where you really control all the
7 environmental factors and--
8 A You mean for the growth itself?
9 Q Yes, for the growth itself.
10 A Yeah, that's usually aluminum.
11 Q Okay. Now would that type of device be
12 used in this process at all? Is this just more of
13 a in-the-pot type of procedure?
14 A Well, depending upon--there are two
15 approaches there and I don't know if the final
16 decision has been made yet. My hope would be to
17 grow it under a completely controlled environment
18 where we gain a lot of information than we would
19 just from a hanging a light in a room. But either
20 is possible, and I guess it depends on the funding
21 that's available and everything else--
22 Q Okay.
0204
1 A --which we use.
2 Q So that type of a chamber, it's a
3 possibility that that could be involved in the
4 process?
5 A Yes.
6 Q And if it is, you already have such a
7 chamber?
8 A I have small ones. I do not have ones--we'd have
9 to purchase larger ones.
10 Q Okay. So, but again the technology is
11 available.
12 A Yes.
13 Q It would just be in a larger--a larger
14 capacity?
15 A Yes, and I showed those to the DEA agents
16 who came to campus to visit. We have them in
17 another building, not in the building where we'd be
18 growing the marijuana or not in the room.
19 Q So even though you've never grown
20 marijuana, you've never grown any other Schedule I
21 controlled substance; right?
22 A No, that's true.
0205
1 Q But I guess from the botany or agronomy or
2 gardening level, the technologies are the same in
3 terms of growing these plants as opposed to any
4 other plant?
5 A I've grown a lot of different plants and
6 they've all--they all grow the same.
7 Q All right.
8 A They take the same water, they take the
9 same nutrients, and I don't think that marijuana is
10 any different.
11 Q Okay. And the equipment that you would
12 use in growing these plants is all equipment that
13 you've used in the past?
14 A It's all standard equipment used in the
15 past, commercially available.
16 MR. TRANT: Thank you very much, Your
17 Honor. That was all. I just wanted to make
18 certain so that to help educate the Deputy
19 Administrator in terms of what this process would
20 entail. I think that's been very helpful. Thank
21 you, Doctor.
22 THE WITNESS: You're welcome.
0206
1 JUDGE BITTNER: Mr. Bayly.
2 MR. BAYLY: Thank you, Judge Bittner.
3 BY MR. BAYLY:
4 Q Thank you, Dr. Craker, for bearing with
5 us, and I say us, there's two of us.
6 A Yes. No problem.
7 Q I won't go through the same questions, but
8 I do have a number of questions based on your
9 testimony yesterday.
10 A Sure.
11 Q I want to start off, though, on one
12 question, just to follow up what Mr. Trant asked
13 you. Would you and the people that help you there
14 at University of Massachusetts, would you have the
15 ability to test the marijuana for THC levels? In
16 other words, you harvest some that you've grown and
17 could you do that?
18 A Well, we have standard laboratory
19 equipment. We have gas chromatographs. We have
20 high pressure liquid chromatographs and those are
21 the type of instruments that are usually used to
22 determine constituents in plants. Yes, we have
0207
1 those available.
2 Q And would you have the capability then of
3 testing for suspected marijuana? In other words,
4 somebody said here, I think, Dr. Craker, this looks
5 like marijuana. It smells like marijuana. Could
6 you test this and confirm it?
7 A Well, I suspect I, if I knew the pattern
8 that came from an analysis of those from marijuana,
9 the pattern that it shows from gas chromatograph or
10 from the high pressure liquid chromatograph,
11 theoretically I could, but that's not my job, and
12 I, even ethylene, which is a problem among growers,
13 I do not volunteer to do their analysis either,
14 even though I've been asked several times.
15 Working with the outside people is
16 generally a responsibility of the Extension
17 Division in our university.
18 Q You say theoretically you could, but also
19 if you wanted to, could you actually do it?
20 A You mean do I have the cap--
21 Q Right.
22 A We have the instruments that could do it,
0208
1 yes. We could certainly learn the techniques if
2 necessary to do it, the proper procedure.
3 Q I want to shift gears here, Dr. Craker,
4 and now take you back in time. If the witness
5 could be shown just Government Exhibit 1, please.
6 A Is that one of these?
7 Q I have a copy if I can present it to the
8 witness. Do we have our originals here?
9 A I have Respondent's Exhibits.
10 JUDGE BITTNER: Do you have a book there
11 that says Government Exhibits?
12 THE WITNESS: No, I do not.
13 JUDGE BITTNER: Okay. Mr. Bayly, you have
14 your copy; right? I mean you have the official
15 copy?
16 MR. BAYLY: We're looking for the
17 official. I do have a copy. It's just the
18 original application. I can present this. We use
19 this for now, Dr. Craker.
20 THE WITNESS: Okay.
21 BY MR. BAYLY:
22 Q I just want to confirm that is the
0209
1 original application that you submitted to DEA?
2 A It looks like the original that was
3 submitted to DEA. But understand I did not do the
4 submission. The Office of Grants and Contracts did
5 the actual submission of the form.
6 Q Well, it's got a date stamp of June 28.
7 A Yes.
8 Q So would you be willing to testify that
9 that was the application initially submitted by
10 University of Massachusetts?
11 A Yes, I would think it looks like it the
12 original one to me.
13 MR. BAYLY: Your Honor, we'd like to now
14 just go ahead and admit Government Exhibit 1. We
15 do have a--well, I guess--I don't know if it's an
16 original but it's a clerk copy as well.
17 JUDGE BITTNER: Okay. Any objection, Ms.
18 Carpenter?
19 MS. CARPENTER: No, Your Honor.
20 JUDGE BITTNER: Okay. Received.
21 [Government's Exhibit No. 1
22 was marked for identification
0210
1 and received in evidence.]
2 MR. BAYLY: Thank you, Judge Bittner. If
3 I may, I'll just take that back.
4 THE WITNESS: Sure.
5 MR. BAYLY: I don't think you'll need it.
6 BY MR. BAYLY:
7 Q Dr. Craker, before you filed this
8 application--
9 A Yes.
10 Q --that's Government Exhibit 1, I
11 understand you were approached by Dr. Doblin?
12 A That is correct.
13 Q How did you know Dr. Doblin? Did he just
14 kind of approach you from out of the blue or did
15 you have any prior contacts with him?
16 A I think the initial approach--I can't
17 recall for sure, but the initial approach was
18 probably a telephone call. That's the way usually
19 people get in contact with me initially. And I
20 assume this would be the same procedure followed by
21 Dr. Doblin, but I can't honestly tell you.
22 Q When he called, did you know who he was,
0211
1 or was this--
2 A I had no idea who he was.
3 Q Okay. Any idea how he found out about
4 you?
5 A Well, there's several answers. He could
6 have possibly picked my name by random, I assume.
7 But I suspect that he probably began investigating
8 people that work with medicinal plants and came
9 across my name. I suspect that. I would hope that
10 would be the case, but he could probably answer
11 that better than I could.
12 Q All right. Now, when you were first
13 contacted by Dr. Doblin, were you aware that there
14 was another cultivator of marijuana registered to
15 provide marijuana for researchers at that point?
16 A I had heard of it being grown, but I had
17 no interest in it at the time and had not followed
18 up on anything about it.
19 Q Now, the initial contact from Dr. Doblin
20 in order for you to file this application, was the
21 rationale that we needed another supplier for
22 researchers?
0212
1 A Well, that was certainly, if I can recall
2 from the conversation, what Dr. Doblin talked
3 about. Whether it was the first conversation we
4 had or secondary conversations, I could not tell
5 you. I was convinced by the--when I began, after
6 he--if I could back up just a little bit. I was
7 initially approached by the state of Massachusetts
8 about growing marijuana, medical marijuana,
9 approximately five to six years before Dr. Doblin
10 spoke to me.
11 And I began to look just a little bit at
12 the marijuana literature that was available, and
13 got interested in that, hey, this may very well be
14 a medicinal plant. It's illegal. So after talking
15 with Dr. Doblin, I began to look more into reports,
16 anecdotal reports and anything else I could find
17 about this and began to visualize this plant as
18 perhaps a medicine that should be available to the
19 public, not to violate security regulations or not
20 to see it diverted into a recreational drug, but
21 to--I thought it could be a medicine that could be
22 used.
0213
1 Q And can you recall, Dr. Craker, your
2 initial contacts with Dr. Doblin? Were there
3 discussions about needing an additional supplier
4 because the current supplier's product was not very
5 good or was the discussion more that we need an
6 additional supplier just because we need more
7 supply?
8 A I never heard that--I honestly can't
9 recall the initial conversations that well even
10 though I try. There were several things talked
11 about. I think we mainly talked about the
12 potential health, possible health benefits of
13 medical marijuana for the patients.
14 We probably talked about the available
15 supply, but I cannot, I honestly cannot recall. In
16 the initial conversations I just have no idea what
17 we all covered.
18 Q Well, Dr. Craker, at the time you filed
19 this application, and we'll go by that date stamp.
20 A Yes.
21 Q It must have been in late June--
22 A Yes.
0214
1 Q --2001. When you filed this application,
2 was it your thinking that the University of
3 Mississippi had an inadequate supply of marijuana
4 to researchers?
5 A At the time this application was filed, I
6 had no idea how much the University of Mississippi
7 was producing. I had a minimal idea that there had
8 been some complaints about quality, but only a
9 minimal idea. I was, I think that probably, that's
10 probably where my thinking rested at the time.
11 Q All right. So would it be fair to say
12 then when you filed the application, you weren't
13 concerned with a lack of quantity, but there had
14 been some, a few reports about quality problems
15 with the University of Mississippi marijuana?
16 A I would say that's probably true. I think
17 that, because as I recall, again, we'd have to--Dr.
18 Doblin could answer--we probably had initial
19 contact probably two months or maybe three months
20 before this application went in.
21 Between that time and the application, I
22 had an opportunity to talk with other people about
0215
1 this, and we became concerned at that time, I
2 guess, about the availability. I wouldn't say
3 quantity necessarily, but the availability to
4 researchers to--again I was primarily concerned
5 with clinical, being able to do clinical trials,
6 and I understood from talking to other people that
7 there was a--that the marijuana from Mississippi
8 may have been of relatively low quality, and that
9 was not readily available to run the clinical
10 trials which some people wanted to run.
11 Q All right. Can you recall or, first of
12 all, was there anybody other than Dr. Doblin that
13 you talked about in terms of the quality problem
14 that you're talking about the University of
15 Mississippi had with its marijuana?
16 A I can't remember anybody specifically
17 because I talked to several, several people during
18 that time. I can't recall anybody specifically and
19 I can't recall all the conversations either. It's
20 been way too far from my mind, my memory, to recall
21 the specific conversations. Again, I talked with
22 everybody I could talk with at the time, and I just
0216
1 have to leave it at that. I would, if I had better
2 answers, I would give them.
3 Q Well, Dr. Craker, do you recall contact or
4 communicating with any researchers who use
5 marijuana before you filed your application in June
6 of 2001?
7 A I remember we talked to, I talked to a
8 medical doctor. I recall, I think I spoke with a
9 friend of mine at Beltsville who had been growing
10 these type of materials.
11 Q Was he using marijuana for clinical
12 research?
13 A No, no. It was--and he was using, growing
14 cocoa for cocaine at the time.
15 JUDGE BITTNER: Doctor, I think you should
16 just for the Deputy Administrator and anyone else
17 who may review this explain what you mean by
18 Beltsville?
19 THE WITNESS: With USDA center in
20 Beltsville, Maryland.
21 JUDGE BITTNER: United States Department
22 of Agriculture?
0217
1 THE WITNESS: Yes.
2 JUDGE BITTNER: Okay.
3 BY MR. BAYLY:
4 Q And perhaps also, Dr. Craker, for the
5 record, for clarity, when we talk about clinical
6 studies, we're talking about research with people,
7 on human subjects?
8 A Well, that would be up to the
9 investigator. That's not my, that's not my--I
10 assume that clinical trials eventually end up with
11 people, as we heard some testimony yesterday that
12 that was--I don't know--they have Phase 1 and Phase
13 2 and Phase 3.
14 Q Well, is it your understanding that you
15 would be supplying marijuana for clinical trials?
16 A My understanding would be that I would be--my
17 understanding is that I would be supplying
18 marijuana to people that wanted to use this
19 material in various DEA approved studies and FDA
20 approved studies, DEA, FDA.
21 Q All right. Other than your friend in
22 Beltsville, were there any other researchers or
0218
1 medical personnel that you talked about in terms of
2 the quality of marijuana before you filed your
3 application here?
4 A Not that I can recall.
5 Q Can you recall the sorts of information
6 that you found out? You said there were a few
7 problems with the quality of the University of
8 Mississippi marijuana. What sources did you check
9 with to find this out before you filed your June
10 28, 2001 application?
11 A I thought I had just told you those--
12 MS. CARPENTER: Objection. Asked and
13 answered, Your Honor.
14 JUDGE BITTNER: I'm not sure. Overruled.
15 Go ahead. Would you like to rephrase the question,
16 Mr. Bayly?
17 MR. BAYLY: All right. Yeah, I think I
18 could.
19 BY MR. BAYLY:
20 Q Were there any other sources that you
21 contacted to confirm or not confirm, as the case
22 may be, about the quality of the University of
0219
1 Mississippi marijuana before you filed your
2 application?
3 A I would say no, nothing other than I've
4 already said.
5 Q Would it be fair to say, Dr. Craker, that
6 this application was filed based on the urging of
7 Dr. Doblin? In other words, if you didn't get the
8 call, would you have filed this application?
9 A That's true. All research at the
10 university is done by source of funding, and
11 without funding, we don't do any research.
12 Q Well, this leads into another topic, Dr.
13 Craker, and I'd like to find out what your--and
14 when I say you, I mean you and the University of
15 Massachusetts--
16 A Yes.
17 Q --relationship is with Dr. Doblin now?
18 Now, Dr. Doblin, I think we all know, is the head
19 of MAPS?
20 A Yes.
21 Q And that stands for?
22 A Multidisciplinary Association for
0220
1 Psychedelic--I don't know what the last--
2 Q Studies?
3 A What?
4 MR. BAYLY: You want to stipulate?
5 MS. CARPENTER: I will stipulate Studies
6 is the last word, yeah.
7 THE WITNESS: Studies. Okay.
8 JUDGE BITTNER: Is it the
9 Multidisciplinary Association for Psychedelic
10 Studies?
11 MS. CARPENTER: Yes.
12 JUDGE BITTNER: Okay.
13 MR. BAYLY: All right. We can stipulate
14 to that again.
15 JUDGE BITTNER: Okay. Received.
16 MR. BAYLY: I know it gets tiring with all
17 these acronyms so--
18 THE WITNESS: Yes.
19 BY MR. BAYLY:
20 Q And MAPS is--your understanding, it's a
21 not-for-profit organization; is that correct?
22 A That's my understanding.
0221
1 Q Okay. Now who is going to pay for the
2 cost of, first of all, of buying any extra
3 equipment that you need to cultivate the marijuana?
4 A This would have to be funded by a research
5 grant.
6 Q A research grant to the university?
7 A To the University of Massachusetts.
8 Q And who would supply that research grant?
9 A Well, the initial funding would, has been--would
10 be raised by MAPS, I'm assuming.
11 Q All right. Now, as MAPS made that money
12 available or is it like in escrow or is there a
13 promissory note or anything of that nature?
14 A No.
15 Q And you've talked a little bit about the
16 security costs, Dr. Craker. Who is going to pay
17 for the security costs for the growing and
18 cultivating of the marijuana? Would that be
19 University of Massachusetts or would you need a
20 research grant?
21 A We would need grants to help support that
22 also.
0222
1 Q And would that come from MAPS?
2 A It could come from MAPS or any other
3 agency that would be willing to contribute.
4 Q When you say "agency," what?
5 A It could be, it could be, it could be
6 another organization interested in supporting the
7 university. We get money from--the university gets
8 money from several sources.
9 Q Dr. Craker, at this point, do you have an
10 estimate of how much money the security would
11 entail to initially install?
12 A Well, I do not have an exact estimate
13 because I don't know exactly what security is going
14 to yet be required. That has not been outlined to
15 me. I mean the, the agents have looked at the
16 room, but they have not, federal agents have not
17 told me anything about what's necessary.
18 Q You mean you've never discussed security
19 requirements with any DEA investigators?
20 A Not with any Drug Enforcement, federal
21 Drug Enforcement Administration people, no. Except
22 for what I've outlined before is they wanted an
0223
1 enclosed room, they wanted the outside wall
2 submerged below the ground level. Beyond that, we
3 have not discussed what would be necessary for
4 security.
5 Q All right. But based on those two
6 requirements that you just mentioned, any cost
7 estimates?
8 A Well, based on those two things, the cost
9 estimates would be practically nil because the room
10 is available to me and it has a lock on the door,
11 if that's all that's necessary. The university
12 will supply that.
13 Q All right. Now, if your application is
14 granted and you cultivate marijuana and you're
15 going to supply it to a researcher, does the
16 researcher pay you as the University of
17 Massachusetts for this marijuana?
18 A Those details are yet to be worked out.
19 Generally, in this type of case, I suspect that
20 there would be some charge to pay for shipping
21 items like this.
22 Q I'm sorry. You said generally what now?
0224
1 A That generally that there would probably
2 be some charges. For example, I would suspect the
3 person who wanted the material would pay for
4 shipping.
5 Q Do you have an idea if the marijuana would
6 be provided at cost or--well, let me back up here--I assume
7 as the University of Massachusetts in your
8 capacity, you're not a for-profit organization; are
9 you?
10 A No.
11 Q And you're not looking to make a profit
12 off of this endeavor?
13 A No. No, that's correct.
14 Q So would it be likely then that the
15 providing of the marijuana would be to reimburse
16 your costs, more or less?
17 A Yes.
18 Q Dr. Craker, are you familiar with the
19 prices that the University of Mississippi charges
20 researchers for the marijuana?
21 A I have no idea.
22 Q Now, will it be MAPS that will direct you
0225
1 to whom to supply the marijuana to? Is that how
2 you find out who your customers are?
3 A Well, that could be one way. I may very
4 well be approached by other people with approved
5 studies who need a source also. At this stage of
6 the game I have really no idea who the potential
7 customers all would be.
8 Q Sorry. Dr. Craker, I'm going to request
9 that you be handed Government Exhibit 3.
10 A Thank you.
11 Q Do you have that?
12 A Yes, I do.
13 Q Okay. Let's go to question, looks like
14 question one. It's the second paragraph, and we're
15 about four or five sentences down. Let's--I'll
16 read it and see, make sure you're with me here, Dr.
17 Craker.
18 It says: MAPS will sponsor research at
19 other institutions using smoked marijuana and
20 marijuana delivered through a vaporizer device.
21 Do you see that?
22 A Yes.
0226
1 Q All right. Now, I assume, and correct me
2 if I'm wrong, but this refers to Chemic; does it
3 not?
4 A I have no idea who it refers to.
5 Q Can you tell us--it says MAPS will sponsor
6 research at other institutions--can you tell us
7 what other institutions?
8 A No, I think that's a question for MAPS to
9 answer.
10 Q All right. So as far as any questions
11 about Chemic then, you're going to refer me to Dr.
12 Doblin?
13 A I would have to. I don't know anything
14 about Chemic.
15 Q Okay. Dr. Craker, has Dr. Doblin given
16 you any suggestions on whom your potential research
17 customers might be?
18 A Well, he certainly indicated to me that in
19 the case of any that MAPS would be working with
20 would be properly licensed.
21 Q Well, I understand that. I'm looking for
22 names, however.
0227
1 A No. They have not been discussed with me.
2 Q Have you yourself canvassed any potential
3 customers?
4 A Have I--the answer to that is no. I have
5 received e-mails from various people indicating
6 that they might be interested if we got a license.
7 Q Did you respond to those e-mails?
8 A I did not.
9 Q Could you tell us who any of those folks
10 are?
11 A No.
12 JUDGE BITTNER: No because?
13 THE WITNESS: No, because I did not, I
14 don't have any record of them with me obviously
15 and, secondly, because I'm not sure they're
16 legitimate requests.
17 JUDGE BITTNER: Okay. So you didn't--
18 THE WITNESS: I didn't make any note of
19 them at all.
20 JUDGE BITTNER: You didn't check these--I
21 don't mean to cross-examine you. I'm sorry.
22 THE WITNESS: No, that's okay.
0228
1 JUDGE BITTNER: Did you check these out at
2 all?
3 THE WITNESS: Not at all.
4 JUDGE BITTNER: You just got them and--
5 THE WITNESS: Not at all. We did not--we
6 don't have a license to manufacture the material,
7 so I get enough e-mails to answer without having to
8 worry about ones that are some time in the future.
9 JUDGE BITTNER: So you didn't respond?
10 THE WITNESS: I did not respond to any of
11 them.
12 JUDGE BITTNER: Okay.
13 BY MR. BAYLY:
14 Q Dr. Craker, have you had any
15 correspondence from or to a pharmaceutical drug
16 company?
17 A No, not that I'm aware of.
18 Q Dr. Craker, I understand--well, let me
19 back up here and rephrase this. Let's look at
20 Government Exhibit 3 here, your answers to the bulk
21 manufacturing questions.
22 A Yes.
0229
1 Q Looks like the second paragraph under
2 question number one, looks like the same sentence I
3 referred to before. I'm just looking at the end of
4 it. It says--well, let me read it. It's short.
5 MAPS will sponsor research at other
6 institutions using smoked marijuana and marijuana
7 delivered through a vaporizer device that heats but
8 does not burn the plant material, thus reducing the
9 products of combustion normally found in smoked
10 marijuana.
11 Do you have an idea of who is developing
12 this vaporizer device?
13 A The exact company, no. I've obviously in
14 talking with Dr. Doblin have become familiar that
15 MAPS is sponsoring research in this area.
16 Q This company, Dr. Craker, do you have any
17 idea of whether they're at this point permitted
18 under law to receive marijuana for research?
19 A I have no idea.
20 Q Do you have any idea what quantity or
21 quality of marijuana this company would need?
22 A I've had no contact with the company.
0230
1 Q All right. Dr. Craker, I understand that
2 you're not intending to do research yourself with
3 the marijuana that you grow and cultivate; is that
4 correct?
5 A That is--I mean--I don't know what you
6 mean by research. Research is a big word that
7 covers a lot of things.
8 Q All right.
9 A Certainly--
10 Q That's fine. Let me break it down then.
11 A Okay.
12 Q Obviously, it's not going to be you the
13 one that is working on a vaporizer device; is that
14 right?
15 A That's certainly true. I'm not a
16 qualified engineer.
17 Q This manufacturing registration, you don't
18 intend to work on any particular devices, do you,
19 that deliver possible--
20 A No.
21 Q --medical marijuana?
22 A No.
0231
1 Q Now is it your intent to--your intent, I
2 understand, is to provide the plant material to any
3 possible researcher or potential pharmaceutical
4 company that would need it for research themselves;
5 is that correct?
6 A That's correct if they have the
7 appropriate licenses.
8 JUDGE BITTNER: Could I jump in here a
9 minute because I have a feeling I'm in the same
10 category as Mr. Trant? I can't keep the deer away
11 from my tomatoes. So are you in a position to, for
12 example, say, supposing you get the registration--
13 THE WITNESS: Yes.
14 JUDGE BITTNER: --and a research, a
15 clinical researcher says, well, you know, I found
16 that with Patient X, the vaporizer did such and
17 such in terms of relief of symptoms, let's say.
18 And with Patient Y, there was a somewhat different
19 response.
20 Based on your expertise with medicinal
21 plants, are you in a position to say maybe it's
22 because of alpha?
0232
1 THE WITNESS: No.
2 JUDGE BITTNER: Okay. So you see where
3 I'm kind of trying to understand. So is your
4 expertise in saying I know how to grow a plant that
5 will have more cellulose in it?
6 THE WITNESS: Yes.
7 JUDGE BITTNER: And less something else?
8 THE WITNESS: Lignin.
9 JUDGE BITTNER: But now what that
10 cellulose is going to do in the human body?
11 THE WITNESS: That's correct.
12 JUDGE BITTNER: Okay. I think I have
13 more, but I have to process that. Okay. Go ahead,
14 Mr. Bayly.
15 MR. BAYLY: All right. Thank you, Judge
16 Bittner.
17 BY MR. BAYLY:
18 Q Dr. Craker, again, I want to refer you
19 to--
20 A Sure.
21 Q --this Government Exhibit 3. And if we
22 could flip over to page two. At the bottom of the
0233
1 page--
2 A Yes.
3 Q You say the goal for the first year is a
4 maximum of 25 pounds dry weight of manicured buds
5 in an FDA approved dosage form. This amount would
6 be from several different strains to ensure
7 researchers a range of potency from about seven to
8 15 percent THC.
9 First of all, you say your goal is to grow
10 a maximum of 25 pounds dry weight. Now would you
11 say--for the first year--and are you able to tell
12 us if that amount of something that a--it's a
13 research amount as opposed to a commercial amount?
14 A I don't understand the point you're trying
15 to get at.
16 Q Well, all right. Let me put it this way.
17 25 pounds is not a lot in terms of amount, is it,
18 in your opinion in terms of wanting to supply to
19 researchers?
20 A Well, it all depends on the plant you're
21 talking about. It's certainly not a lot for some
22 plants, but it looks like a lot for me for
0234
1 marijuana.
2 JUDGE BITTNER: It would be a lot of
3 saffron.
4 THE WITNESS: Uh?
5 JUDGE BITTNER: It would be a lot of
6 saffron.
7 THE WITNESS: A lot of?
8 JUDGE BITTNER: Saffron.
9 THE WITNESS: Be a lot of saffron. We
10 should have that, yes.
11 [Laughter.]
12 BY MR. BAYLY:
13 Q All right. Well, let me ask you, if you
14 get there--let's say you get the registration
15 tomorrow.
16 A Yes.
17 Q That you're going to be registered.
18 A Yes.
19 Q Would you now at that point start planting
20 and making arrangements to grow up to 25 pounds?
21 A No. There would be, we'd have to install
22 the security required. We would have to purchase
0235
1 the necessary equipment. I assume that would
2 probably take at least six months.
3 Q Well, right now, you don't have any
4 pharmaceutical companies in mind to--
5 A No.
6 Q --be a customer?
7 A No.
8 Q And you don't have any researchers that
9 you know of except one that is going to develop a
10 vaporizer; is that correct?
11 A That's correct.
12 Q Now, given that status, Dr. Craker, would
13 you still commence--I understand after you put in
14 the security and what have you--
15 A Yes.
16 Q --would you still commence to grow the
17 marijuana?
18 A Well, I certainly think we would start to
19 commence to grow some marijuana because the system
20 needs to be checked and see if it all works.
21 That's probably the first go-around.
22 Q Well, this goal of developing 25 pounds,
0236
1 is that for the purpose of seeing if, how the whole
2 operation is going to work?
3 A No, I think that part of that would be
4 available if requested by appropriately licensed
5 people. That could be used to supply them also.
6 Q All right. Then the question is, Dr.
7 Craker, would you start to grow this 25 pounds for
8 researchers without actually having a commitment
9 from a researcher or pharmaceutical company?
10 A No, I would want to have a commitment
11 that--how much--we need to have a commitment of how
12 much the researcher needed and we need to have a
13 commitment of what THC level they needed in the
14 material.
15 Q Okay. And at this point, you don't have
16 that?
17 A I have not.
18 Q Dr. Craker, I'm going to refer you to the
19 same sentence that I just mentioned in Government
20 Exhibit 3 here, bottom of page two.
21 A Yes.
22 Q It says the goal for the first year is a
0237
1 maximum of 25 pounds dry weight of manicured buds
2 in an FDA-approved dosage form. What do you mean
3 by "an FDA-approved dosage form"?
4 A Well, to me, this meant in a dried ground
5 material.
6 Q So that would not include extracts or
7 anything of that nature?
8 A No.
9 Q Moving on, in the same answer here, on the
10 bottom of page two, top of page three, your answer
11 indicates this amount would be from several
12 different strains to ensure researchers a range of
13 potencies from about seven to 15 percent THC.
14 Dr. Craker, at this time, are you aware of
15 any researchers that would need any specific THC
16 potency amounts in this range? In other words,
17 there's somebody saying, Dr. Craker, I need 12
18 percent THC?
19 A The answer to that is no, I have not
20 received any researcher directly telling me that.
21 The comments I have received from researchers have
22 indicated that this is the type, the range they
0238
1 would like to be working in.
2 Q Can you tell us what researchers gave you
3 that information?
4 A These are--I cannot tell you the names of
5 any of them. Again, my apologies. But I go to
6 several medicinal plant conferences throughout the
7 year, and this is a general indication of the type
8 of range that should be used.
9 Q Dr. Craker, do you have any information
10 that these researchers are not getting this
11 percentage of this range of THC from the University
12 of Mississippi?
13 A I have no direct evidence that they're
14 not.
15 Q Dr. Craker, do you hold any patents with
16 regard to growing medicinal plants?
17 A No.
18 Q Do you have any patents of this nature
19 pending?
20 A No.
21 JUDGE BITTNER: When you say "you," I just
22 want to--does the University of Massachusetts have
0239
1 any patents for things you grew? I mean have you
2 had anything to do with any patent?
3 THE WITNESS: With reference to medicinal
4 plants, no.
5 JUDGE BITTNER: Okay. With anything else?
6 THE WITNESS: Directly, no. Indirectly,
7 one of our, the university does patent some
8 flowers, for agricultural plants, some vegetable
9 plants, and I'm in the same department.
10 JUDGE BITTNER: Okay.
11 BY MR. BAYLY:
12 Q Now, Dr. Craker, if you supply marijuana
13 to researchers, well, let me back up here--let me
14 make sure--let me ask you this. I believe
15 yesterday on direct testimony, you indicated that
16 the supplying of the marijuana would not be for
17 smoked marijuana studies; is that correct?
18 A That's my understand--yes, the initial
19 type of studies for what I'm aware of would be the
20 vaporizer studies. That's all I'm aware of.
21 Q Was that also, were you aware of that at
22 the time you filed your application?
0240
1 A Yes.
2 Q Would you please look at Government
3 Exhibit 3.
4 A Yes.
5 Q Again, I'm sorry to skip around.
6 A That's okay.
7 Q But we're back on page one, paragraph one.
8 In fact, I think it's sentence in the application
9 answer that I've already read. It says: MAPS will
10 sponsor research at other institutions using smoked
11 marijuana. And that's what you put on your--
12 A Yes.
13 Q All right.
14 A Well, I had no idea at the time that we
15 were filling this out where the applications may
16 come from. The only intent I had in mind at the
17 time, the only thing I was aware of was vaporizer
18 studies.
19 Q So where did you get the using "smoked
20 marijuana"? What--
21 A Well, that probably came because it's a
22 common delivery source. If you ask me to write
0241
1 this answer today, I would leave the "smoked" out
2 because now that I've read more on the smoked
3 marijuana, I find that less attractive delivery
4 means.
5 JUDGE BITTNER: So would you be willing to
6 limited and to say I won't provide any marijuana
7 for smoking or do you want to have that option
8 open? I'm not trying to put you on the spot. I
9 don't know if you've thought about it.
10 THE WITNESS: I have not thought about
11 that at all. And we have, the, and again as we get
12 more into it, the science is divided on that. I
13 mean I think that I've read various studies that
14 says the smoked marijuana is a good way to deliver
15 it and smoked marijuana is a bad way to deliver it.
16 I would, I'm not in favor of the smoked
17 marijuana not only because of the possible
18 carcinogens, I'm against smoking in general, and
19 don't look at that as a nice thing to do. But if
20 that's the delivery system that is most effective,
21 then I don't think that we should eliminate it
22 entirely.
0242
1 JUDGE BITTNER: Would you have any
2 interest in, again, because I know nothing about
3 medicinal plants.
4 THE WITNESS: Yes.
5 JUDGE BITTNER: So I'm asking questions
6 that might be kind of stupid. Would you have any
7 interest, for example, down the road, supposing you
8 get this registration, of working on developing
9 plants that wouldn't have the harmful components
10 that would be a problem with smoking or is that not
11 possible?
12 THE WITNESS: That is very possible, and
13 that would be a great idea.
14 JUDGE BITTNER: Okay.
15 BY MR. BAYLY:
16 Q Now, Dr. Craker, if you do supply
17 marijuana for smoking to a researcher--
18 A Yes.
19 Q --would you be in the position to supply
20 the cigarette papers, the marijuana cigarette
21 papers for the--
22 A I have no supply of papers. I have no
0243
1 supply of papers currently. I mean I expect that
2 they probably can be ordered and purchased.
3 Q Well, then, would you, are you planning to
4 send it to the research in bulk, and they will roll
5 it? Are you planning to--
6 A That would be my intention.
7 Q All right. Dr. Craker, let's talk a
8 little bit. I think you mentioned this, and we
9 want to just get some more estimates here. I think
10 you said it's going to take a certain amount of
11 time to put in the security.
12 A Yes.
13 Q Okay. But you're not certain what the
14 actual security requirements are at this time?
15 A That's true. Yes.
16 Q And then the next step would be to grow
17 the marijuana, to see if it works for lack of a
18 better--
19 A Yes.
20 Q And how long would that process take
21 about?
22 A Well, I suspect that would probably take
0244
1 a--we would probably have some idea whether things
2 are going to work probably in the period of three
3 to six months.
4 Q Sorry to skip around. But I got a few
5 more questions about potency.
6 A Sure.
7 Q I think you've indicated both on your
8 application that--and from conferences that you
9 heard that the potency that researchers might need
10 would range from seven to 15 percent?
11 A Yes.
12 Q When you found out about the potency range
13 being from seven to 15 percent at these
14 conferences, were these conferences that you
15 attended after you filed your application?
16 A Yes. Most of them I would say yes.
17 Q And were most of them filed after you
18 filed these questions in Government Exhibit 3?
19 A Probably some of them were, but some of
20 them were certainly--it's another one of those
21 things I've not personally kept track of when I
22 talked to people.
0245
1 Q All right.
2 A It could be either way.
3 Q Okay. Thank you. Would these potency
4 ranges from seven to 15 percent, these are potency
5 ranges that you're saying the researchers would use
6 for clinical trials on people, on humans?
7 A They could use them on humans if they had
8 again the appropriate licenses to do so.
9 Q Okay. When you say "appropriate
10 licenses," just digress here for a second here, Dr.
11 Craker.
12 A Sure.
13 Q What do you mean by "appropriate
14 licenses"?
15 A I mean if they have FDA approval for
16 clinical trials and that they have any regulations
17 to handle these class of materials. I'm trying to
18 emphasize I'm not going to send this material off
19 to someone that would misappropriate it.
20 Q Well, I'll assume that if you develop a 15
21 percent THC content marijuana, that you'll be
22 sending it to a researcher that is licensed to use
0246
1 this marijuana on humans.
2 Do you have any idea what effect 15
3 percent THC would have on a human subject?
4 A I have no idea. That's not in
5 horticulture.
6 Q Dr. Craker, is it your understanding at
7 this time that the current supplier of marijuana to
8 researchers, and you know that's the University of
9 Mississippi--
10 A Yes.
11 Q --supplies an inferior quality of
12 marijuana to the researchers?
13 A I have no direct evidence.
14 Q One way or the other?
15 A One way or the other.
16 Q So I take it then you've had no
17 opportunity to examine or confer with anybody at
18 the University of Mississippi in order to assess
19 their marijuana?
20 A No, I've talked to the principal
21 investigator at a conference last week, but we did
22 not discuss that.
0247
1 Q Now have you ever found out from any
2 source, Dr. Craker, that the University of
3 Mississippi was unable to supply a sufficient
4 quantity to the researchers and they said they ran
5 out, said I don't have any more?
6 A I've never come across that, no.
7 Q Now, I think you--well, I know you
8 testified that at one point about the time you
9 filed your application here that you had heard
10 about some complaints about the quality of the
11 University of Mississippi marijuana; is that
12 correct?
13 A Yes.
14 Q Do you know if the University of
15 Mississippi was ever apprised of these complaints?
16 A I have no idea.
17 Q Do you know if the University of
18 Mississippi ever had an opportunity to address
19 these complaints?
20 A I have no idea.
21 Q To your knowledge, has any researcher ever
22 made a direct complaint to the University of
0248
1 Mississippi about the quality of its marijuana?
2 A I have no idea.
3 Q Dr. Craker, I want to ask you a few
4 questions and we may be able to zip through this
5 topic because I'm not sure you've got information
6 about it, and if you don't, you don't. But are you
7 aware of researchers who have been denied the
8 University of Mississippi marijuana by NIDA?
9 A I have no information.
10 Q Okay.
11 JUDGE BITTNER: And NIDA is?
12 MR. BAYLY: National Institute of Drug
13 Abuse.
14 JUDGE BITTNER: Is it "of" or "on,"
15 probably not "for"?
16 MS. CARPENTER: I think it's "on."
17 MR. BAYLY: Yeah, "on."
18 JUDGE BITTNER: I don't know. Okay. I'll
19 look it up and let you know.
20 MR. BAYLY: Another acronym.
21 BY MR. BAYLY:
22 Q All right. So I take it also, Dr. Craker,
0249
1 you wouldn't have any knowledge about marijuana
2 research protocols that have been rejected by the
3 NIDA in the years 2003 or 2004?
4 A I have no idea.
5 Q Or even this year?
6 A No.
7 Q Are you aware that the University of
8 Mississippi is under a contract with NIDA and?
9 A Yes, I am aware of that.
10 Q And you're aware that this contract now
11 allows the University of Mississippi to cultivate
12 marijuana in order to supply researchers?
13 A I have no idea what the contract. I am
14 not privileged to the contract.
15 Q I think you testified yesterday, Dr.
16 Craker, that you did receive a copy of a bid--
17 A Yes.
18 Q --to compete--
19 A I did.
20 Q --a contract?
21 A Yes.
22 Q And this bid to compete for this contract,
0250
1 was that not for the NIDA contract that the
2 University of Mississippi now has?
3 A Yes. I assume it's the same one anyway.
4 Q Well, there's no other cultivator of
5 marijuana, at least legally, other than the
6 University of Mississippi at this time; is that
7 correct? To your knowledge?
8 A Well, for the manufacture of marijuana,
9 yes. I mean there are, there are other places
10 where marijuana is being grown legally.
11 Q Well, when you say manufacturing, I think
12 for purposes of your registration, it would be
13 growing, cultivating marijuana?
14 A Yes.
15 Q And you obtained this notice to bid for
16 the contract, and that was for--that was sometime
17 in 2004?
18 A I don't think so. I think it was 2005.
19 Q Okay.
20 A But I don't know.
21 Q But in any event, fairly recently?
22 A Fairly very recently. We're in 2005;
0251
1 aren't we? Yes.
2 Q All right. And you chose not to compete
3 on the bid for this contract?
4 A That's true.
5 Q I think you said that yesterday as well.
6 A Yes, I did, yes.
7 Q Now, if I'm not mistaken, Dr. Craker, I
8 think one of the reasons you gave was that you
9 didn't feel you had the experience that the
10 University of Mississippi had and therefore there
11 wouldn't be much point in competing on this
12 contract?
13 A That was one of the reasons, yes.
14 Q And the other reason was you weren't--I
15 think you said you weren't interested in doing
16 analysis or assessing marijuana; is that correct?
17 A That's correct.
18 MR. BAYLY: Your Honor, I'd like the
19 witness to be shown Government Exhibit 13.
20 JUDGE BITTNER: Okay. I think you have
21 those, Mr. Bayly.
22 MR. BAYLY: Okay.
0252
1 JUDGE BITTNER: I think you have the
2 official copies of the ones that haven't been
3 received; am I right, Nicole?
4 MR. BAYLY: I'm sorry. Yeah. We may
5 have--should have given it to the clerk, but we
6 have the official--
7 JUDGE BITTNER: Okay.
8 MS. CARPENTER: We have it, yeah. Thanks.
9 THE WITNESS: Thank you.
10 BY MR. BAYLY:
11 Q Thank you. Dr. Craker, I just handed you
12 Government Exhibit 13. And I'll represent that
13 that is the contract between NIDA and the
14 University of Mississippi and if you go to the
15 second page--
16 A Yes.
17 Q --Dr. Craker, and the second paragraph, it
18 says in addition to analysis of grown material,
19 analyses shall be performed on approximately 100
20 samples of confiscated marijuana each month which
21 are provided by the Drug Enforcement
22 Administration.
0253
1 These analyses provide a means of
2 determining potency trends of illicit marijuana by
3 determination of the--I'm going to say THC rather
4 than pronounce that--concentration and also of
5 screening for herbicide contamination which might
6 create a public health problem.
7 Now, I believe you indicated yesterday
8 that the other reason you didn't choose to compete
9 on this contract was you weren't interested in
10 doing that aspect of it?
11 A Yes.
12 Q Dr. Craker, if you get this registration,
13 you wouldn't be the only person that would be
14 cultivating, drying, getting the marijuana ready to
15 be sent and all the other things you need to do,
16 would you? Would you have some help?
17 A Well, I usually have help in all projects,
18 yes.
19 Q All right. And what kind of--have you
20 planned who's going to help out and do what? Have
21 you made any plans?
22 A I mean we're an educational institution.
0254
1 I assume there would be graduate students that
2 would be interested in any type of project. We
3 hire technicians at the university to do work, and
4 I assume that they would participate in this in
5 some manner.
6 Q But you don't know how yet?
7 A I don't know how. I mean I usually don't
8 go down and water the plants in the greenhouse; I
9 usually, I have a technician that does that.
10 Q Other than that, any plans for what these
11 graduate students would do?
12 A I have no plans currently. It depends on
13 the graduate students you get and what their
14 interests are. They vary all over the board. Some
15 of them come interested in everything from growing
16 plants to determining the effect of environmental,
17 of variables on plants. It's very difficult to
18 predict what a student will be interested in down
19 the road.
20 Q What would be--what would be some of the
21 tasks that they would do?
22 A Well, we talked about watering. They
0255
1 would probably do the transplanting. They would
2 do--I don't know. I assume there would have to be
3 a daily check on any environmental controls we
4 have. They'd have to do that. These are the type
5 of things.
6 MR. BAYLY: All right. Your Honor, I'd
7 like Dr. Craker to be shown Government Exhibit 30,
8 and again we'll have to supply that.
9 JUDGE BITTNER: Can I just ask, Doctor--
10 THE WITNESS: Yes.
11 JUDGE BITTNER: --do you have any
12 experience with having to provide security for
13 plants?
14 THE WITNESS: I have personally no. The
15 only security I'm aware that I've dealt with in
16 plants has to do with my work at the U.S. Army in
17 Fort Detrick, Maryland, which was secret work we
18 did there.
19 JUDGE BITTNER: Okay. But you haven't
20 worked on growing, say, extremely rare or valuable
21 plants that had--
22 THE WITNESS: No.
0256
1 JUDGE BITTNER: Like the iris gardens that
2 got trashed the other day. Off the record.
3 [Discussion held off the record.]
4 JUDGE BITTNER: On the record. Okay. Mr.
5 Bayly, did you find your exhibit?
6 MR. BAYLY: Yes.
7 JUDGE BITTNER: Okay.
8 MR. BAYLY: And I'd like to present Dr.
9 Craker with Exhibit 30, Government Exhibit 30.
10 JUDGE BITTNER: Okay.
11 THE WITNESS: Thank you.
12 BY MR. BAYLY:
13 Q Dr. Craker--
14 A Yes.
15 Q --I just presented you with Government
16 Exhibit 30, and this purports to be a letter from
17 you to Frank Sapienza, who was then with the Drug
18 Enforcement Administration.
19 A Yes.
20 Q Is this a letter you wrote to him?
21 A It has my signature on it, and I would
22 assume this is the letter I wrote to him.
0257
1 Q And this is dated June 2, 2003?
2 A Yes.
3 Q All right. So you indicate--I'm going to
4 refer you--
5 MS. CARPENTER: Just for a minute, for the
6 witness to have a chance to read the letter before
7 he answers questions about it.
8 THE WITNESS: I'm sorry. I did not hear.
9 MS. CARPENTER: Do you need a minute to
10 read the letter before you answer questions about
11 it?
12 THE WITNESS: I'd like--unless he's going
13 to refer to a specific part that I can read. I
14 mean I can--it looks like--may I read it?
15 MR. BAYLY: Well, yeah. I was going to
16 read the excerpts but if you want to review the
17 whole letter.
18 JUDGE BITTNER: Why don't we just go off
19 the record and give the witness--I don't think we
20 really need to read it into the record. You can
21 just refer to paragraphs.
22 MR. BAYLY: That's fine.
0258
1 JUDGE BITTNER: Again, if it's received,
2 I'll read it.
3 MS. CARPENTER: It was just that it was
4 sometime ago, and I want to make sure Dr. Craker
5 remembers it.
6 JUDGE BITTNER: Right. Okay. Let's go
7 off the record for a minute.
8 [Off the record.]
9 JUDGE BITTNER: Back on the record.
10 BY MR. BAYLY:
11 Q Dr. Craker, have you had a chance to
12 review Government Exhibit 30, the letter from you
13 to Frank Sapienza?
14 A I've done a read of it, yes.
15 Q All right. I want to refer you to an
16 excerpt in the first paragraph.
17 A Yes.
18 Q You indicate, quote, "A second source of
19 plant material is needed to facilitate privately
20 funded FDA approved research into medical uses of
21 marijuana."
22 Now, at the time you wrote this letter to
0259
1 Frank Sapienza, there was, you had no specific
2 researchers in mind; did you?
3 A That's true.
4 Q And the last sentence in this letter--
5 A Yes, the last sentence in the letter?
6 Q I'm sorry. Last sentence in the first
7 paragraph of the letter.
8 A Yes.
9 Q I apologize. Let me read it here because
10 it's short so we'll get the context:
11 Ultimate testing of marijuana for
12 medicinal use will undoubtedly cost several
13 millions of dollars and expense that private drug
14 companies will be hesitant to invest without
15 assurances of being able to evaluate various plant
16 sources.
17 First of all, could you be a little more
18 specific about the amount of cost other than
19 several million or can you? I mean can you--
20 A I can't be. I've taken this from
21 anecdotal evidence, anecdotal things you read in
22 the newspaper that it costs several million dollars
0260
1 to develop a drug.
2 Q All right. So there hasn't been any
3 specific pharmaceutical company--
4 A No.
5 Q --that gave you that estimate?
6 A No.
7 Q And you didn't get this information from
8 any specific pharmaceutical drug company
9 representative?
10 A No.
11 Q Did any specific pharmaceutical drug
12 company representative give you the information
13 that their company would be hesitant to invest
14 without assurances of being able to evaluate
15 various plant sources?
16 A Reference to marijuana, no.
17 Q Okay. Let's drop down to I think
18 paragraph two. I'll quote it again.
19 Quote: "While I recognize that the primary
20 researchers now receiving plant material may openly
21 state to you that they are satisfied with the
22 current source, I am sure you appreciate that in
0261
1 private conversations, these same researchers
2 indicate a fear of having the current supply
3 eliminated if they complain about the available
4 source material."
5 So I just want to ask you a few questions
6 about that.
7 A Certainly.
8 Q When you wrote this letter to Frank
9 Sapienza, did you have any specific information
10 that any of these researchers had contacted DEA to
11 express dissatisfaction with NIDA marijuana?
12 A I had no information that they had
13 contacted NIDA, no.
14 MR. BAYLY: I'm trying to find this.
15 Maybe somebody can help me out here. I'm looking
16 for a quote, and it says in private conversations,
17 these same researchers indicate a fear of having
18 the current supply eliminated if they complain
19 about the available source material. That would be
20 the second paragraph.
21 JUDGE BITTNER: Oh, here you go. I am
22 sure you appreciate that in private conversations--second
0262
1 line, second paragraph.
2 MR. BAYLY: Right. Maybe I should read
3 the whole sentence for context.
4 MS. CARPENTER: That would be a good idea.
5 MR. BAYLY: The whole sentence is, quote:
6 "While I recognize that the primary researchers now
7 receiving plant material may openly state to you
8 that they're satisfied with the current source, I'm
9 sure you appreciate that in private conversations
10 these same researchers indicate a fear of having
11 the current supply eliminated if they complain
12 about the available source material."
13 BY MR. BAYLY:
14 Q The question is, Dr. Craker, do you know
15 what researchers have made these private
16 complaints?
17 A By name, no. Again, this results from e-mails
18 that I've had.
19 Q E-mails from whom?
20 A Various individuals and whether they are
21 legitimate or not, I have no idea.
22 Q Okay. So you can't say that these e-mails
0263
1 are even from--
2 A I can't even say these people were getting
3 the material from NIDA at the time, no.
4 Q Are you aware of the CMCR researchers in
5 California?
6 A No.
7 JUDGE BITTNER: I'm sorry. I think we
8 need the acronym spelled out. This is a quiz, Mr.
9 Bayly.
10 MR. BAYLY: Center for Medicinal Cannabis
11 Research. We had some exhibits on that, I think.
12 I think probably Defense does too.
13 MS. CARPENTER: Yes, that's the name.
14 JUDGE BITTNER: I'm sorry. The Center?
15 MS. CARPENTER: The Center for Cannabis--
16 MR. HOPPER: Center for Medicinal Cannabis
17 Research.
18 MS. CARPENTER: --Research.
19 MR. HOPPER: CMCR.
20 JUDGE BITTNER: Guess who no longer knows
21 the alphabet. CMCR.
22 MS. CARPENTER: Right.
0264
1 JUDGE BITTNER: Okay.
2 BY MR. BAYLY:
3 Q Right. So you won't be able to tell us if
4 any of these CMCR researchers made any complaints
5 about the University of Mississippi?
6 A I would not have any idea.
7 Q Okay. Now, your letter--this is going
8 down to the next to the last paragraph, Dr. Craker.
9 Third paragraph. It starts out, quote: "To
10 illustrate the problem of quality, I've enclosed
11 copies of two documents for your review, both of
12 which I know you are familiar. The letter you
13 received from Dr. Russo and an article from the San
14 Mateo County Times quoting Dr. Israelski, Director
15 of Medical Research at the San Mateo"--I think it
16 meant Medical Center in California.
17 A Umm, misspelling.
18 Q Probably a misprint. Have you ever spoken
19 with Dr. Israelski?
20 A No.
21 Q Did you actually see a quote in this
22 article where he complained about the marijuana?
0265
1 A Without looking at the original article, I
2 have no idea.
3 MR. BAYLY: Your Honor, I'd like to
4 present Dr. Craker with a copy of--it's not a
5 Government Exhibit, but I'd mark it I guess for
6 identification as a Government Exhibit. It's San
7 Mateo County Times article.
8 MS. CARPENTER: Was this previously
9 furnished to us?
10 MR. BAYLY: No, this was not. This was
11 only used for cross-examination. It's not a--
12 MS. CARPENTER: I'm sorry. I had
13 understood we had to introduce all documents that
14 were going to be used. Is there a rule about cross
15 examination that's different?
16 JUDGE BITTNER: No. It's that you have to
17 exchange or advise all documents that you intend to
18 offer into evidence.
19 MS. CARPENTER: Into evidence. Okay.
20 JUDGE BITTNER: I don't know if this is
21 going to be offered or not.
22 MS. CARPENTER: Okay. I understand.
0266
1 JUDGE BITTNER: I haven't gotten that far.
2 MS. CARPENTER: Okay. Well, I would have
3 objection if it's going to be offered into
4 evidence.
5 JUDGE BITTNER: Well, I'll let you show it
6 to the witness and we'll see what happens.
7 MR. BAYLY: All right. Your Honor, may I
8 approach you and give you a copy too?
9 JUDGE BITTNER: Sure.
10 MR. BAYLY: So we're all on the same page,
11 so to speak.
12 JUDGE BITTNER: As it were.
13 MR. BAYLY: And I have one for Dr. Craker.
14 MS. CARPENTER: I guess I'd just like to
15 know are you representing that this is what was
16 attached to the letter? Is that the relevance of
17 this?
18 MR. BAYLY: Yes.
19 MS. CARPENTER: Okay. And do we have some
20 evidence of that?
21 MR. BAYLY: I'm sorry?
22 JUDGE BITTNER: Well, I think that's where
0267
1 we're going.
2 MS. CARPENTER: Okay.
3 MR. BAYLY: I have to ask the witness.
4 MS. CARPENTER: Got it.
5 JUDGE BITTNER: Right. Okay.
6 BY MR. BAYLY:
7 Q Dr. Craker, I just handed you a copy of
8 what's been identified as a San Mateo County Times
9 news article. It's dated January 24, 2003, and to
10 the best of your knowledge, is this the article
11 that you're referring to in the letter in
12 Government Exhibit 30?
13 A I don't see the date, the January 24, or
14 June 24 on here anyplace. Oh, from the January 24
15 from the date of the paper, you mean? Not the date
16 of the--
17 Q Right. It's, you go down several lines
18 and then you see staff writer.
19 JUDGE BITTNER: Under the byline.
20 THE WITNESS: Yeah, in the byline. I see
21 where you're getting the January 24 from now, yes.
22 BY MR. BAYLY:
0268
1 Q Right. It says Friday, January 24, 2003.
2 A Yes.
3 Q Is this, to the best of your knowledge,
4 what was attached to the letter to Frank Sapienza
5 by you?
6 A I honestly cannot say, but if it came, if
7 your records show that it came with the memorandum,
8 I assume that it's probably what I sent. But you'd
9 have to testify to that, not me. I have no idea.
10 JUDGE BITTNER: Oh, I see. Okay.
11 BY MR. BAYLY:
12 Q Well, referring to this letter then, is
13 there any quote from Dr. Israelski that the
14 marijuana from the University of Mississippi has
15 quality problems?
16 MS. CARPENTER: Objection. That
17 mischaracterizes the letter that Dr. Craker sent in
18 which he just says I enclosed two copies of a
19 document quoting Dr. Israelski. It doesn't say
20 what the quote is in reference to.
21 JUDGE BITTNER: Sustained. I guess the
22 question--well, Mr. Bayly, would you rephrase your
0269
1 question?
2 MR. BAYLY: I'm sorry?
3 JUDGE BITTNER: Would you rephrase your
4 question?
5 MR. BAYLY: Okay.
6 BY MR. BAYLY:
7 Q Dr. Craker, was this letter sent to Frank
8 Sapienza to illustrate that Dr. Israelski himself
9 had problems with the quality of the marijuana that
10 University of Mississippi provided?
11 A Not necessarily.
12 MS. CARPENTER: Just for clarification,
13 when you say "this letter," you're talking about
14 the letter, not the article?
15 MR. BAYLY: I'm sorry. The article, the
16 San Mateo article.
17 THE WITNESS: I'm confused about what
18 we're talking about now.
19 JUDGE BITTNER: Okay. The document that
20 Mr. Bayly just gave you--
21 THE WITNESS: Yes.
22 JUDGE BITTNER: --which appears to be
0270
1 something from a Web site.
2 THE WITNESS: Yes.
3 MS. CARPENTER: I'm sorry. Let me just
4 make one other objection. There's also no
5 foundation that shows that this is the one that was
6 sent.
7 JUDGE BITTNER: Right. But no pointing,
8 Ms. Carpenter.
9 MS. CARPENTER: Sorry.
10 JUDGE BITTNER: All right.
11 MS. CARPENTER: I forgot your rule.
12 JUDGE BITTNER: Okay. I believe the issue
13 that Mr. Bayly is addressing is do you know if this
14 document or a copy thereof is what you attached to
15 Government Exhibit 30 when you sent it to Mr.
16 Sapienza?
17 THE WITNESS: I have no idea if this is
18 the exact one that I attached. I would assume it
19 is because Mr. Bayly says it is.
20 JUDGE BITTNER: Well, no. Mr. Bayly is
21 not testifying.
22 THE WITNESS: I know he's not testifying,
0271
1 but I would believe him.
2 [Laughter.]
3 JUDGE BITTNER: But do you recall what you
4 attached to the letter?
5 THE WITNESS: Well, all I recall is what
6 I've said here. I have no idea if this is the one
7 or not.
8 JUDGE BITTNER: Okay.
9 BY MR. BAYLY:
10 Q Well, Dr. Craker, you sent some news
11 articles from the San Mateo County Times in this
12 letter, and that's what you indicated in the
13 letter. Is that right?
14 A Yes, yes.
15 Q And if it weren't this, what else would it
16 be?
17 A I have no idea if there are other
18 articles. I have no idea. I mean I just can't
19 honestly answer that. I assume this is the one.
20 Q All right. But given that you're assuming
21 this is the one, is there anything in there that
22 indicates that Dr. Israelski had some complaints
0272
1 about the University of Mississippi marijuana
2 quality?
3 A There's no direct quote that I see in it
4 that says that he had a problem. What he talks
5 about is a variety of factors. To me, the headline
6 in this story, the first line, which I assume from
7 my journalism class several years ago, you put the
8 most important thing first. And says that the
9 medical marijuana study want a better quality.
10 Q All right. It says: Doctors conducting a
11 groundbreaking medical marijuana study want better
12 quality weed from the federal government. But you
13 don't know who those doctors are?
14 A I have no idea.
15 Q And you didn't check with the reporter to
16 confirm who these doctors were?
17 A I did not.
18 Q And there's no way to determine whose
19 these doctors are? They may not even be
20 researchers; is that correct?
21 A Well, we have, both you and I have no idea
22 who these doctors are. We can leave it at that. I
0273
1 have no idea. I assume that the staff right here--
2 Jean Whitney writing the article attempted to do a
3 good job and probably talked with appropriate type
4 of doctors.
5 Q All right. Dr. Craker, you didn't check
6 with Dr. Israelski--
7 A I did not.
8 Q Now you also mentioned a letter from Dr.
9 Russo in--now, again, to clarify here, Government
10 Exhibit 30, that's your letter to Frank Sapienza,
11 June 2, 2003. And down to the third paragraph,
12 first sentence, quote, "To illustrate the problem
13 of quality, I have enclosed copies of two documents
14 for your review, both of which I know you're
15 familiar, the letter you received from Dr. Russo
16 and an article from the San Mateo County Times."
17 Now, I'm going to refer to the letter from
18 Dr. Russo. Actually Dr. Russo himself. Do you
19 know Dr. Russo personally?
20 A I have met Dr. Russo.
21 Q When did you meet him?
22 A The date I cannot recall. He's given a
0274
1 seminar in our department.
2 Q How long ago was that?
3 A Over a year. Maybe probably over two
4 years. I mean it could be three years. I don't
5 know the exact date.
6 Q Okay. Well, have you ever talked to or
7 corresponded with Dr. Russo about any complaints he
8 may have had about the Mississippi marijuana?
9 A Again, I did not understand your question.
10 Q Have you ever talked to or corresponded
11 with Dr. Russo about any complaints he may have had
12 about the marijuana provided by the University of
13 Mississippi for research?
14 A I've not had any correspondence with him
15 directly. We have, we've talked the time he gave
16 the seminar. We certainly talked about that issue.
17 Q Right. And what did he tell you?
18 A He told me that, well, again, my
19 recollection of the direct conversations is faded,
20 but from my memorandum here, we probably, we
21 probably talked about what was the problem with the
22 Mississippi source.
0275
1 Q And what was the problem according to what
2 you were talking about with Dr. Russo?
3 A I cannot directly attribute this to Dr.
4 Russo because of the number of times I've talked
5 with different people, but the general thing that's
6 been talked about is the material has been of poor
7 quality, that it's included stem tissue and other
8 artifacts, and that it has low potency.
9 Q Okay. But you're saying you can't recall
10 getting that information from Dr. Russo?
11 A I've talked to several people, and I can't
12 recall if that's directly for Dr. Russo or if it's
13 from some other people I've talked to at a
14 conference.
15 Q Do you know if Dr. Russo is currently a
16 researcher?
17 A I have no idea.
18 Q Do you know if Dr. Russo is currently
19 seeking any marijuana from any source to conduct
20 research?
21 A I have no idea.
22 Q Dr. Craker, I wanted to clarify one thing.
0276
1 I think earlier we talked about, I think both
2 yesterday and today, about you getting a notice, a
3 bid to compete for the NIDA contract?
4 A Yes.
5 Q Now, you did get that notice mailed
6 directly to you?
7 A I can't remember. It came by mail or e-mail.
8 Q Okay. But you didn't have to look in the
9 Federal Register and find it?
10 A No.
11 Q And that did come before the contract was
12 awarded; did it not?
13 A Yes, I recall it didn't come too soon
14 before the contract was awarded, but I mean it was
15 not a lot of lead time. That I recall.
16 MR. BAYLY: All right. Your Honor, if I
17 may just have a minute, please?
18 JUDGE BITTNER: Uh-huh.
19 MR. BAYLY: Thank you.
20 BY MR. BAYLY:
21 Q Dr. Craker, is it--I'm going to go back to
0277
1 just a couple of questions on funding. Is it your
2 understanding that you'll have a continual grant
3 from MAPS if you get this registration to cultivate
4 marijuana?
5 A No, that's not my understanding. I would
6 hope that would be true, but it's not my
7 understanding.
8 Q Well, if the MAPS funding doesn't come
9 through, let's say it comes through initially but
10 then it dries up, what would you anticipate being
11 the source of your income for the cultivation of
12 marijuana?
13 A Well, the source would have to be, as I
14 think we've answered before, would have to be from
15 other agencies, whether they were private
16 organizations or other government agencies that
17 were interested in sponsoring some type of research
18 on this. We'd have to search for funding.
19 Q Okay. And Dr. Craker, I understand that
20 the contract that you got the bid for, the NIDA
21 contract in 2004--
22 A Yes.
0278
1 Q And you chose not to compete for that; is
2 that correct?
3 A That's correct.
4 Q And you know that that's every five years?
5 A Yes. I do now.
6 Q You do now. Okay. So that would make it
7 2009 and are you planning to complete on that?
8 A I have not made any decision there at all.
9 That's a little bit too far away. That's nice lead
10 time, but it's a little bit too far. Too much lead
11 time.
12 MR. BAYLY: Your Honor, I'd like to admit
13 Government Exhibit 30 into evidence. That's the
14 letter from Dr. Craker to Frank Sapienza and I
15 asked some questions on. It's dated June 2, 2003.
16 JUDGE BITTNER: Any objection?
17 MS. CARPENTER: No, Your Honor.
18 JUDGE BITTNER: Okay. Government 30 is
19 received.
20 [Government's Exhibit No. 30
21 was marked for identification
22 and received in evidence.]
0279
1 MR. BAYLY: Do we have a yellow copy of
2 30? Can I get it from Dr. Craker unless on
3 redirect, if you want him to keep the letter?
4 MS. CARPENTER: Yes, that would be great.
5 JUDGE BITTNER: Let's mark it and give it
6 back to the clerk, and then if necessary we can
7 give it back to Dr. Craker so that she has
8 everything that's received.
9 MR. BAYLY: I got to tell you I had the
10 experience of a witness I gave him a--it was a DEA
11 witness, too--even more embarrassing. I gave him a
12 copy that was supposed to be in evidence, and
13 before I could put it into evidence, he ran away
14 with it.
15 JUDGE BITTNER: I think that was my case.
16 [Laughter.]
17 JUDGE BITTNER: Okay. So, Nicole, would
18 you please retrieve exhibit. Okay. Do you have
19 anything else, Mr. Bayly?
20 MR. BAYLY: No. I'm done at this point.
21 JUDGE BITTNER: Okay. Let's take a ten
22 minute break before cross--redirect. I'm sorry.
0280
1 [Whereupon, a short recess was taken.]
2 JUDGE BITTNER: On the record. I think
3 we're ready for redirect.
4 MS. CARPENTER: We are, Your Honor, and
5 once again we have talked with Government counsel
6 and they have agreed to let us go out of order.
7 JUDGE BITTNER: Okay.
8 MS. CARPENTER: If you don't mind breaking
9 up Dr. Craker's testimony one more time, we have a
10 very short witness who's been here most of the
11 morning, Dr. Barbara Roberts. Her testimony will
12 be very short and we thought if we could just get
13 her on and off, she wouldn't have to come back
14 after lunch.
15 JUDGE BITTNER: Okay.
16 MS. CARPENTER: So we call Dr. Barbara
17 Roberts to the stand.
18 JUDGE BITTNER: Dr. Craker must be feeling
19 like a patchwork quilt.
20 [Laughter.]
21 JUDGE BITTNER: Dr. Roberts, if you would
22 come up here, please, and if you would stand and
0281
1 raise your right hand.
2 Whereupon,
3 BARBARA ROBERTS, PH.D.
4 was called as a witness herein and, having been
5 first duly sworn by the Administrative Law Judge,
6 was examined and testified as follows:
7 JUDGE BITTNER: Please be seated, and
8 there should be a fresh cup and some water over
9 there.
10 THE WITNESS: Oh, I see both.
11 JUDGE BITTNER: Okay.
12 DIRECT EXAMINATION
13 BY MS. CARPENTER:
14 Q Dr. Roberts, could you state your name and
15 address for the record?
16 A Yes. It's Dr. Barbara Roberts, and I'm a
17 resident of Washington, D.C., 1346 Montique Street,
18 Northwest.
19 Q Okay. And what's your current position,
20 Dr. Roberts? What's your job?
21 A I'm a clinical associate professor in the
22 Department of Psychiatry at Georgetown University
0282
1 Medical Center.
2 Q Okay.
3 A And I'm also a psychotherapist in private
4 practice here in the city.
5 Q So I assume you have your Ph.D.?
6 A I do.
7 Q And what other degrees do you hold?
8 A I have a master's degree in psychology and
9 a B.A. degree in psychology as well.
10 MS. CARPENTER: Okay.
11 JUDGE BITTNER: So it's a Ph.D., not an
12 M.D.?
13 THE WITNESS: Ph.D.
14 JUDGE BITTNER: Okay.
15 BY MS. CARPENTER:
16 Q Have you worked in the government
17 previously?
18 A I have.
19 Q And where have you worked in the
20 government?
21 A In various locations and in offices. My
22 last position was for about nine and a half years
0283
1 in the White House Office of National Drug Control
2 Policy.
3 Q Okay. Would that be ONDCP?
4 A ONDCP.
5 Q Okay. And what did you do when you were
6 there?
7 A I held two positions. One, I was a senior
8 policy analyst in the, both in the Office of Demand
9 Reduction, as a senior policy analyst looking at
10 all issues having to deal with treatment of abused
11 substances and particularly for the mandate for
12 that office, which was heroin and cocaine but also
13 substances of potential abuse to underage users.
14 Looking at barriers to treatment, creating
15 access to treatment, looking at health-related
16 issues in the area of treatment.
17 Q Okay. Did you work with NIDA at all in
18 connection with that work?
19 A NIDA is one of 55 agencies that have
20 mandates for substance abuse issues, and therefore
21 report to the Office of National Drug Control
22 Policy. NIDA conducts about 85 percent of the
0284
1 world's research in substance abuse policy and to
2 that extent we had considerable engagements and
3 encounters with dealings with that office.
4 Q Okay. Did the issue of medical marijuana
5 come up during your time at ONDCP?
6 A Yes, it did.
7 Q And how did that come up? What was the
8 context?
9 A Well, primarily in regards to underage
10 use.
11 Q Let me just be clear. This was medical
12 marijuana?
13 A Medical--oh, in terms of medical
14 marijuana.
15 Q Medical marijuana, right.
16 A In terms of the use of it by people not
17 under age but at any age who might have problems of
18 wasting diseases or who had difficulty with other
19 kinds of medical disorders and who wanted to be
20 able to use medical marijuana, medicinal marijuana
21 for those purposes.
22 Q And how did that come up at the ONDCP?
0285
1 Why was it an issue?
2 A Primarily it came up as a very huge and
3 very public issue during the time that Barry
4 McCaffrey was the Director, that person known as
5 the drug czar, for that office, and there were a
6 number of proposals I that were pending in
7 California and did pass to allow the use, permit
8 the use of--and Oregon too I believe at the time--of
9 medicinal marijuana, and he became very much
10 engaged on that point, and took some positions that
11 primarily in terms of and attempts perhaps--I don't
12 want to mischaracterize this, but in terms of
13 physicians who might want to engage with patients
14 and so he took some positions about perhaps
15 prohibiting that use, but it became a very public
16 discussion about that.
17 And he certainly did bring himself up to
18 date on what the issues were and then took a
19 position on that. He was very vocal on that, but I
20 think that there was a recognition at some point
21 that it was becoming very personal and that he was
22 getting in the middle of a lot of issues and there
0286
1 was some suits that were taken, lawsuits that were
2 filed against him on that point, and there was a
3 considerable amount of discussion in the office
4 about the best means for dealing with that.
5 And it was at one of these meetings that I
6 recommended that an office that we had extremely
7 high regard for and in terms of the work that they
8 do, and that was in the Institute of Medicine, to
9 let them study this issue in terms of any kind of
10 benefits from the use of marijuana in which the
11 Director, or the Drug Czar, General McCaffrey could
12 then announce that his office was recommending that
13 the Institute of Medicine study this issue which
14 would then take him out of the spotlight, but also
15 defer to this august body in terms of where we
16 should go on this issue. And, in fact, was there
17 any viable reason to study it in that regard?
18 Q So that was your suggestion?
19 A To him and to my, first, to my immediate
20 supervisor who at that time was Fred Garcia, who
21 was the--he was the Deputy Director for Demand
22 Reduction in that office, and he agency did accept
0287
1 that position and the IOM did, the Institute of
2 Medicine did take upon itself that study, and I
3 think they make some reference to the fact how they
4 came to become involved in that in their executive
5 summary.
6 Q Okay. Could I ask you to turn to, in the
7 first book there, Respondent's Exhibit No. 1?
8 JUDGE BITTNER: Could I just ask, Dr.
9 Roberts, what is the Institute of Medicine?
10 THE WITNESS: The Institute of Medicine is
11 a body that is formed from the National Sciences
12 Academy in which they take leading researchers and
13 scientists to study particular issues and to form
14 the state of the art in terms of thinking and
15 direction on matters of scientific matters.
16 JUDGE BITTNER: So it's like a medical
17 think tank?
18 THE WITNESS: A medical think tank.
19 JUDGE BITTNER: And it is funded by?
20 THE WITNESS: Congress.
21 JUDGE BITTNER: Okay. So it is a federal
22 agency?
0288
1 THE WITNESS: Yes, yes.
2 JUDGE BITTNER: Okay.
3 BY MS. CARPENTER:
4 Q Is it part of NIH or is independent; do
5 you know?
6 A It's a part of the National Science
7 Academy, NSA.
8 Q NSA?
9 A Yes.
10 JUDGE BITTNER: Is it the National Academy
11 of Science?
12 MS. CARPENTER: Oh, NAS, right.
13 THE WITNESS: National--I'm sorry.
14 National Academy of Sciences.
15 JUDGE BITTNER: That's okay. I figured
16 next we were going to go on the shuttle and--
17 [Laughter.]
18 JUDGE BITTNER: Okay.
19 THE WITNESS: Did you say the Respondent's
20 Exhibits?
21 BY MS. CARPENTER:
22 Q Yes, it's a--
0289
1 JUDGE BITTNER: It's a big thick one.
2 MS. CARPENTER: Big thick one. Number
3 one.
4 THE WITNESS: Okay. There are two big
5 thick ones over here. Under No. 1, yes.
6 BY MS. CARPENTER:
7 Q Have you seen that document before?
8 A Yes.
9 Q And can you tell the Court what it is?
10 A Tell you what it is. It is the marijuana
11 in medicine assessing the science base. It's a
12 study conducted by the Institute of Medicine.
13 Q And did you see this when it came out?
14 A Yes.
15 MS. CARPENTER: Okay. At this time, I
16 would move the admission of Respondent's Exhibit 1
17 into evidence.
18 MR. BAYLY: May I address that?
19 JUDGE BITTNER: Sure.
20 MR. BAYLY: Thank you, Judge Bittner. I
21 wanted to make what I will call partial objection
22 because we have to make sure we are in the bounds
0290
1 of your order, Judge Bittner, the order granting at
2 least in part the Government's Motion in Limine not
3 to delve into all these research issues.
4 On the other hand, I realize that it would
5 be an impossible task to redact what we would
6 consider not in compliance with your order. So
7 with that, I would not object to the admission of
8 Respondent Exhibit No. 1, but I would like for the
9 record to have it admitted with the understanding
10 that your order, Judge Bittner, would limit what it
11 can be used for in terms of admissibility.
12 JUDGE BITTNER: Okay. Ms. Carpenter.
13 MS. CARPENTER: Could I respond to that
14 briefly? There were certainly specific exhibits
15 that were excluded as not being necessary given the
16 stipulations and the statute that authorized
17 regulation and the Government's stipulation that--I'm sorry-
18 -that authorized research and that
19 research is ongoing.
20 I think it's very hard to admit an exhibit
21 just partially, as Mr. Bayly just said, and while
22 we are not going to argue extensively about the
0291
1 therapeutic benefits of it, I think that exhibit
2 should be admitted as a full exhibit because it is
3 the context in which the pieces of it that we're
4 going to draw out are based, and I think it's
5 important for the record to be complete about what
6 that context is.
7 So I would urge that it be admitted with
8 my assurances to the Court that we're not going to
9 spend a lot of time going through it in terms of
10 therapeutic benefits.
11 JUDGE BITTNER: Thank you. My thinking
12 when I granted the Motion in Limine, at least in
13 substantial part, was that whether marijuana should
14 stay in Schedule I is not an issue in this case,
15 and I think everybody agrees with that assessment.
16 Respondent's side is nodding their heads.
17 Mr. Bayly, you're not.
18 MS. CARPENTER: We certainly do, Your
19 Honor.
20 JUDGE BITTNER: Or are you?
21 MR. BAYLY: I'm nodding in agreement.
22 JUDGE BITTNER: Okay.
0292
1 MR. BAYLY: I'm not falling asleep.
2 JUDGE BITTNER: I thought you probably
3 would. Okay. Now, and consequently evidence from
4 individuals who have or have not found therapeutic
5 benefit to marijuana per se is useless to me
6 because that's not an issue in this case.
7 I do think, however, and because we didn't
8 get the complete copy of Respondent 1, well, and
9 also because it's huge, I haven't read it. I just
10 kind of glanced at it to make sure it was complete.
11 I think the evidence as to the state of the issue
12 may be relevant. I'm not sure yet.
13 In other words, it may be in terms of
14 looking at the public interest aspect of this
15 application relevant as to what has been done and
16 what various authorities think needs to be done,
17 and it's basically impossible to have evidence on
18 those issues without having some indication of what
19 they think the results were.
20 So with that caveat, I will receive the
21 exhibit, but I do want to emphasize the parties
22 stipulated that research is ongoing. No one is
0293
1 arguing that research should not be ongoing or at
2 least nobody so far is arguing that position in
3 this case, and the question of whether or not there
4 is indeed a medical use for marijuana is not any
5 issue here.
6 I realize it may be an issue in a lot of
7 other places but not in this room, so with that,
8 Respondent's 1 is received.
9 [Respondent's Exhibit No. 1
10 was marked for identification
11 and received in evidence.]
12 MS. CARPENTER: Thank you, Your Honor.
13 JUDGE BITTNER: And of course, you are all
14 going to brief how much I should rely on it.
15 [Laughter.]
16 BY MS. CARPENTER:
17 Q Dr. Roberts, let me just step back. I
18 think you said you saw this when it came out. Were
19 you still with the Office of--ONDCP at that time?
20 A Yes, yes.
21 Q And do you recall what the reaction was at
22 the agency when the report came out?
0294
1 A Well, I would say probably muted would be
2 a good way to describe it. I don't think that it
3 was necessarily what had been expected, but I
4 certainly did accept the report, but I don't think
5 much happened with it after that point in time.
6 Q Okay.
7 A There was a recognition that it would have
8 been produced. We, when I say we, ONDCP, paid for
9 the study, but I don't recall that there was
10 anything significant that happened after--
11 Q Okay.
12 A --after it was--at least on the part of
13 our office.
14 Q Okay. Do you recall whether there were
15 any task forces set up to implement any of the
16 recommendations?
17 A Oh, no.
18 Q No.
19 A No, there were not, uh-uh.
20 Q Do you recall generally, and this is very
21 general, given the thickness of the report,
22 generally what the conclusions were of the report?
0295
1 MS. PAREDES: Objection. It's outside the
2 scope of the summary from prehearing statements.
3 MS. CARPENTER: I think we said she would
4 talk about the IOM report.
5 JUDGE BITTNER: And this would have been
6 in the initials; right?
7 MS. CARPENTER: Or the supplemental. I
8 don't think it changed.
9 JUDGE BITTNER: Okay. So it's actually
10 the first supplemental. If I had the first
11 supplemental tabbed, I'd have just about
12 everything?
13 MS. CARPENTER: That's right.
14 JUDGE BITTNER: Because, but the first
15 supplemental isn't then repeated in subsequent
16 supplementals; right?
17 MS. CARPENTER: That's right. Because
18 they were just so short and simply added a few
19 sentences.
20 JUDGE BITTNER: Okay.
21 MS. CARPENTER: I was trying to cut down
22 on paper.
0296
1 JUDGE BITTNER: Okay. Now, all I need to
2 do is find it. Here we go.
3 MS. CARPENTER: I'm sorry that those pages
4 are not numbered, but it's very close to the end.
5 It looks about like five, five or six pages back
6 from the end.
7 JUDGE BITTNER: Here we go. I've, of
8 course, forgotten what the question was.
9 MS. CARPENTER: I think the question was,
10 it was do you recall generally the results or the
11 conclusions of the IOM report? And our proposed
12 testimony was during her tenure she specifically
13 recommended that the National Academy of Sciences
14 be commissioned to undertake a review of the
15 scientific evidence regarding therapeutic
16 applications of marijuana.
17 It seems to me to flow directly f