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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 from that
18 that you would say what were those conclusions?
19 JUDGE BITTNER: Yeah, she really doesn't
20 refer to the conclusions from the report, and of
21 course since it's in evidence, I'll read it. So
22 I'll sustain the objection.
0297
1 MS. CARPENTER: Okay.
2 BY MS. CARPENTER:
3 Q Can I ask you to turn to page 22 of the
4 report?
5 A I did.
6 Q Do you have that?
7 A Yes.
8 Q Do you see recommendation number two?
9 A Yes.
10 Q That says clinical trials of cannabinoid
11 drugs for symptom management should be conducted
12 with the goal of developing rapid onset, reliable
13 and safe delivery systems.
14 A Yes.
15 Q Do you recall whether ONDCP took any steps
16 to implement a recommendation similar to that?
17 JUDGE BITTNER: I'm sorry. What page are
18 you on in the report?
19 MS. CARPENTER: I'm sorry. 22 of Exhibit
20 No., Respondent's Exhibit 1.
21 JUDGE BITTNER: And that's the automatic
22 stamp page 22?
0298
1 MS. CARPENTER: Yes, the Bates stamp
2 number to be clear about that, the number at the
3 bottom of the page.
4 THE WITNESS: No, I don't think any
5 actions were taken to. If it came up, it would
6 have been deferred to NIDA, but there were no, in
7 terms of an endorsement of the recommendation, no.
8 BY MS. CARPENTER:
9 Q Okay. Was there any discussion that you
10 recall about the need for a separate rapid onset,
11 reliable and safe delivery system?
12 A There was discussion certainly about the
13 recommendations in the report because we continued
14 to be bombarded with questions about the outcome of
15 the study, the IOM study, but there was no formal
16 action taken, as I recall--
17 Q Okay.
18 A --to say, you know, we need to have a road
19 map to implement the recommendations, and we have
20 done that with other at the time, with other
21 reports that have come out, but I don't recall that
22 happening in this instance.
0299
1 Q Okay. In those discussions, do you recall
2 whether there was general approval of the notion
3 that marijuana could be delivered in non-smoked
4 delivery way that would be better?
5 A I think there was still a great deal of
6 skepticism about that.
7 Q Okay. Was there any discussion at the
8 time of vaporization devices as an alternative to
9 smoking?
10 A Discussion, but action, no. Discussion,
11 yes, but action, no.
12 Q Okay. Could I ask you to turn to page
13 234?
14 A 234.
15 Q Bates stamp number is at the bottom of the
16 page of Respondent's Exhibit 1.
17 A 234?
18 Q Yes. And give me just a moment, Your
19 Honor. I don't have--oh, here we go. In the
20 second paragraph, the first full paragraph that
21 starts: That marijuana smoked, that marijuana is
22 smoked. If you go down about halfway through
0300
1 starting with the sentence: Marijuana delivered in
2 a novel way that avoids smoking would overcome some
3 but not all of the regulatory concerns.
4 A Yes.
5 Q Do you see that sentence? Sorry.
6 A Yes.
7 Q Okay. And it continues: Vaporization
8 devices that permit inhalation of plant
9 cannabinoids without the carcinogenic combustion
10 products found in smoke are under development by
11 several groups.
12 JUDGE BITTNER: I'm sorry, Ms. Carpenter.
13 Where are you?
14 MS. CARPENTER: It's the middle paragraph
15 on page 234 of Respondent's Exhibit A. The
16 paragraph starts with: That marijuana is smoked.
17 Okay.
18 JUDGE BITTNER: Uh-huh.
19 BY MS. CARPENTER:
20 Q So again was there any discussion back at
21 ONDCP about vaporization devices that would permit
22 inhalation without the carcinogens?
0301
1 A Well, obviously I don't have the records,
2 but I don't recall that there was an effort to look
3 at recommending to NIDA to pursue that as that
4 recommendation.
5 Q Okay.
6 A About vaporization as opposed to smoking.
7 Q Okay.
8 A Yeah.
9 Q And did you have any discussions with NIDA
10 about this issue?
11 A I don't recall that there were discussions
12 with NIDA. As far as pursuing the recommendation?
13 Q Right. Of the IOM report.
14 A No. No, no, no.
15 Q Okay. So to your knowledge, did NIDA or
16 ONDCP ever decide that vaporization of medical
17 marijuana was a goal that they would actively
18 support?
19 A No, it was not.
20 MS. CARPENTER: Okay. Could I have the
21 report, just for a moment?
22 JUDGE BITTNER: Uh-huh.
0302
1 BY MS. CARPENTER:
2 Q And let me just ask you as based on your
3 experience in working with public policy, what's
4 your view about how medical marijuana, the issue
5 should be resolved?
6 A Oh, the same as I would say for any other
7 plant substance, is that it needs to be
8 investigated by the scientists who have the
9 background and experience and training,
10 researchers, to delve into that subject.
11 It's marijuana and its active ingredient,
12 of course, are THC. It's highly controversial, but
13 if there is a medical benefit, then I think that
14 certainly coming down on the side of research to
15 once and for all to resolve the problem, and the
16 issue of its efficacy, and the IOM in a way really
17 provided a blueprint for us, or the go-ahead sign
18 to say to do this, to investigate this and to put
19 it to rest.
20 A tremendous amount of money is spent in
21 the prohibition of its use for medicinal purposes,
22 but certainly I think having the research to
0303
1 resolve this issue would be most beneficial.
2 Q And do you think that having an
3 alternative source to the marijuana that's
4 currently available for medical marijuana would
5 encourage that sort of research?
6 A I think it certainly would encourage
7 competition and NIDA of course does so much of the
8 world's research, as I mentioned previously, but I
9 don't think that there is any, if it can be vouched
10 safe in terms of the security of the product, I
11 really don't see that there is any reason not to
12 have an alternative source in order to pursue.
13 MS. CARPENTER: I have no further
14 questions.
15 JUDGE BITTNER: Okay. Cross.
16 CROSS-EXAMINATION
17 BY MS. PAREDES:
18 Q Dr. Roberts, when did you receive your
19 degrees?
20 A I received my B.A. degree in 1967, my
21 master's in 1969 and my doctorate in clinical
22 psychology as a major and statistics as a minor in
0304
1 1977.
2 Q And do you have a medical degree?
3 A No, I do not. I have a doctor of
4 philosophy degree.
5 Q Do you have any specialized training in
6 the field of drug policy?
7 A I've had considerable experiences and
8 training in different areas, and certainly in
9 working with professors in the field in terms of
10 substance abuse.
11 Q Well, would you call that specialized
12 training?
13 A Yes.
14 Q And when did you get this specialized
15 training?
16 A That would have started in when I was in
17 the federal prison system and that was through the
18 Bureau of Prisons and prior to that. It was in the
19 Department of Justice.
20 JUDGE BITTNER: I assume you were working
21 in the federal prison system?
22 THE WITNESS: Decidedly. Let me clear
0305
1 that up.
2 [Laughter.]
3 THE WITNESS: My husband did you used to
4 say my wife went from prison and then she went to
5 drugs, but--
6 [Laughter.]
7 THE WITNESS: But for the record, that was
8 in training in the Federal Bureau of Prisons
9 System.
10 BY MS. PAREDES:
11 Q And when did you work with the Federal
12 Bureau of Prisons?
13 A That was 197--the early '70s, '72, I think
14 it was, to '73, '71 to '73, somewhere in there.
15 Q So about for two or three years?
16 A No, it was about for a little over a year
17 that I was there with them.
18 Q And what was your position there?
19 A I was a clinical intern and looking at
20 issues of substance abuse and also the Youth
21 Sentencing Act, which was an opportunity at that
22 time for people who were--the judge was uncertain
0306
1 about whether this person should be in a confined
2 setting or not to send them to a federal prison for
3 evaluation and many of those instances involved
4 people who were charged with substance abuse
5 offenses.
6 Q And when you were at the Federal Bureau of
7 Prisons, were you involved in drug policy, making
8 drug policy?
9 A Oh, no. I was a student.
10 Q I'm sorry. You were a student at the
11 time?
12 A I was a clinical intern, yes.
13 Q Okay.
14 A It was a part of your doctoral training.
15 Q And then when you, from there you moved on
16 to the Department of Justice?
17 A It was through the Department of Justice
18 and Bureau of Prisons that I was at that facility.
19 From there I moved to the, I was in the military as
20 a civilian employee, and worked with establishing
21 the first substance abuse program for the military
22 at Aberdeen Proving Ground in Maryland.
0307
1 Q And what did you do to establish the
2 substance abuse program?
3 A Well, it had been mandated by law,
4 primarily prior to that time, most programs had
5 been for the treatment of alcohol use or dependence
6 and the mandate specifically was to move it into
7 the direction of looking at the use of people who
8 were dependent on drugs and primarily at that time,
9 the focus was on marijuana.
10 Q Did you also--were you also involved then
11 with other controlled substances aside from
12 marijuana?
13 A That was the primary one, but of course
14 there were, you dealt with whatever was presented
15 to you at the time, but marijuana was the primary
16 drug that we focused on. Every once in awhile you
17 find someone who had used heroin, but that was not
18 as frequent as the use of--people who presented
19 with the use of marijuana.
20 Q And how long were you in this position?
21 A That was approximately a year that I was
22 there.
0308
1 Q One year?
2 A It was about one year, yeah, and then I
3 went on maternity leave.
4 Q So from 19--can you estimate 197--
5 A Oh, that would have been like '73 to--'72
6 to '73.
7 Q Okay. And then were you employed after
8 that by the Department of Justice?
9 A No, no, no. The Department of Justice,
10 the Bureau of Prisons used to come under the
11 Department of Justice before it became a separate
12 entity. Federal prison installations were under
13 the Department of Justice before they received a
14 separate office and that was the Bureau of Prisons.
15 So, but after I left the military
16 position, I was employed at a university.
17 Q At what university?
18 A That was the University of Oklahoma and
19 that was, that was a very, very short period of
20 time. Then I went to the Veterans Administration
21 Medical Center and the Health Sciences Center at
22 the University of Oklahoma. It was a dual position
0309
1 Q And when did you begin your career of
2 employment with the Department of Justice?
3 A It was when I was in the prison system.
4 Q Okay. And then when did you start your
5 career at ONDCP?
6 A That started in 1994.
7 Q And what was your position there?
8 A I was a senior policy analyst.
9 Q For Demand Reduction?
10 A For the Office of Demand Reduction, yes.
11 Q Okay. Was that your only position at
12 ONDCP?
13 A My last year that I was there, I was the
14 Interim Associate Department Director for the
15 Office of Demand Reduction.
16 Q Interim Associate Deputy Director?
17 A Uh-huh.
18 Q For the Office of Demand Reduction?
19 A That is correct.
20 Q Was that because--well, what does interim
21 mean?
22 A Acting. They did not have a--that
0310
1 position had to been filled.
2 Q How long were you in that position?
3 A It was about a year.
4 Q Okay. And then when did you--was that
5 your last employment with federal government?
6 A That's correct. I took--
7 Q When did you--I assume you retired?
8 A I took the early retirement in August of
9 2003.
10 Q In when?
11 A August 2003.
12 Q And is it correct that your last year when
13 you were the Acting Associate Deputy Director?
14 A That's correct.
15 JUDGE BITTNER: Was it Acting Associate
16 Deputy Director or Associate Director?
17 THE WITNESS: Acting Associate Deputy
18 Director for the Office of Demand Reduction.
19 JUDGE BITTNER: Okay. I left out an
20 adjective in there. Okay.
21 BY MS. PAREDES:
22 Q So it would have been 2002 to 2003
0311
1 approximately?
2 A Yes, yes.
3 Q Now have you ever taught in the field of
4 drug policy?
5 A I taught in the field of substance abuse,
6 substance abuse policy. I'm doing that now.
7 Q And what do you mean by substance abuse
8 policy compared to drug policy? How do you
9 differentiate between--
10 A I would think the terms are
11 interchangeable.
12 Q Okay. So what are you teaching in
13 substance abuse policy?
14 A Well, you're looking at from a national,
15 at least what I'm doing, is looking at a national
16 perspective with the residents, where I'm currently
17 employed in terms of what are the issues that, the
18 data sets that we need to look at on the national
19 positions or the state and local positions on
20 substance abuse usage and in terms of this access
21 to treatment and barriers to treatment, and it
22 takes the residents more or less from a perspective
0312
1 of looking at it and just in terms of a treatment
2 issue, but that treatment is really part and parcel
3 of global positions that people take about in terms
4 of what we know about the particular substances of
5 abuse.
6 JUDGE BITTNER: Now when you say
7 "residents," you're referring to physicians?
8 THE WITNESS: Physicians who are--
9 JUDGE BITTNER: Are residents at
10 Georgetown?
11 THE WITNESS: Who are--that is correct.
12 That is correct. Yes, yes.
13 JUDGE BITTNER: Okay. Not residents of a
14 treatment facility.
15 THE WITNESS: No, no, no, no.
16 JUDGE BITTNER: Okay.
17 BY MS. PAREDES:
18 Q Are there any other areas in which you
19 taught in the field of drug policy aside from what
20 you just described?
21 A Probably some of that would have--I got
22 more involved in policy starting in 1990, 1990, so
0313
1 prior to that time, I was more the administrative.
2 I had gone from treating clinician to the
3 administrative side and then to policy. So that
4 would have started in 2000.
5 Q Okay. Are you published?
6 A Not in terms of benchmark research, no,
7 uh-uh.
8 Q In other regards are you published?
9 A No, not really in terms of scientific
10 papers, no, uh-uh.
11 Q Okay. Have you ever previously testified?
12 Have you ever testified under oath before today?
13 MS. CARPENTER: Objection. Relevance.
14 MS. PAREDES: Testified as an expert on
15 the subject of drug policy?
16 JUDGE BITTNER: Is she being proffered as
17 an expert?
18 MS. CARPENTER: No, we have not proffered
19 her as an expert. I'm sort--
20 JUDGE BITTNER: Okay. Sustained.
21 BY MS. PAREDES: I believe the first
22 prehearing submission had a drug policy expert and
0314
1 when we objected to Dr. Roberts' testimony, Ms.
2 Carpenter referred us to the first prehearing
3 submission which proffered a drug policy expert.
4 MS. CARPENTER: Dr. Roberts was in our
5 original prehearing submission, and separately was
6 a drug policy expert. So we are not offering her,
7 nor does it say in our prehearing statement I
8 believe that we offered her as an expert.
9 JUDGE BITTNER: I think Dr. Roberts was
10 proffered only on the subject of what Respondent
11 Exhibit 1 is and how it came about.
12 MS. CARPENTER: Right.
13 JUDGE BITTNER: That was my understanding.
14 MS. CARPENTER: That's right. And her
15 experience in terms of working at ONDCP at the time
16 it came about.
17 JUDGE BITTNER: Right.
18 BY MS. PAREDES:
19 Q Well, Dr. Roberts, what were your duties
20 as a senior policy analyst?
21 A Well, once again, it was all matters and
22 my specific focus was looking at health-related
0315
1 issues and what are some of the barriers for people
2 who are trying to from a national perspective in
3 terms of the formulation of policy for the
4 administration, what are some of the barriers to
5 people accessing treatment, and how could we, we
6 being the government, break down some of those
7 barriers, facilitate people not having to wait for
8 treatment, so it was treatment on demand. If you
9 need it, you're able to get it.
10 So to that extent, we would also look at
11 issues such as we only at the time that I started,
12 there were no medications for the treatment of
13 cocaine abuse. So that we would look at issues
14 such as how long does it take to bring a medication
15 to market; are there people out there who are
16 actually doing research in this area? What does it
17 take in order to get people more involve in this to
18 facilitate that process for heroin abuse or for
19 cocaine addiction or for people who said, well, you
20 know what, we also believe that there are certain
21 beneficial effects of the use of marijuana, and
22 then exploring that as well.
0316
1 So looking at, looking at it from a public
2 health perspective, looking at the barriers,
3 looking at increasing access for people who were
4 trying to deal with these problems, so the
5 administration could then formulate policy around
6 this area and say this is what we need to do and
7 this is where we need to drive our resources in
8 order to facilitate this particular problem.
9 Q And what kinds of barriers to people did
10 you find, people accessing treatment?
11 MS. CARPENTER: Can I just--a quick
12 objection? Still, I think this goes beyond the
13 scope of the direct examination. I think she
14 testified that was what she had focused on, but it
15 certainly was not anything more than that. I'm
16 happy to let it go forward. I'm a little concerned
17 about the time.
18 JUDGE BITTNER: It may be beyond the scope
19 of direct. It's not beyond the scope of the
20 prehearing statement. But I don't think the
21 witness testified about barriers to treatment. So
22 if you're willing to let that not be in.
0317
1 MS. CARPENTER: I think she mentioned that
2 that was some of the work that she had done as she
3 came into ONDCP.
4 JUDGE BITTNER: Okay. Then I'll overrule
5 the objection.
6 MS. CARPENTER: So, okay. That's fine.
7 JUDGE BITTNER: Now would you repeat the
8 question, Ms. Parades?
9 MS. CARPENTER: Yes, sorry.
10 BY MS. PAREDES:
11 Q What kinds of barriers did you find that
12 prevented people from accessing treatment?
13 A There could be numerous barriers. It
14 could be lack of sufficient or a variety of
15 medications in terms to deal with a particular
16 problem. It could be insufficient numbers of
17 treatment programs to deal with a particular
18 problem. It could be in terms of reimbursement by
19 third-party payers, health care providers, to cover
20 the cost of treatment. It could be geographic in
21 terms of one being too far from a particular, just
22 due to where they lived, too far away to access
0318
1 treatment.
2 Q And what were your duties as the Interim
3 Associate Deputy Director?
4 A That was more in terms of the coordination
5 of the activities of the office, very much
6 administrative and in terms of driving the issues,
7 not just my own issues, but the issues of all of
8 the staff in the office there for the coordination
9 of the activities of the Deputy Director for that
10 office.
11 Q And did you then report directly to the
12 Deputy Director?
13 A That is correct.
14 Q And then who did the Deputy Director
15 report to?
16 A Deputy Director reported to the Director.
17 Q And at that time that would have been Mr.
18 McCaffrey?
19 A That would have been John Walters.
20 MS. CARPENTER: Just a clarification. At
21 what time?
22 BY MS. PAREDES:
0319
1 Q At the time that you were the Interim
2 Associate Director?
3 A That would have been John. Yes, you're
4 correct. That would have been John Walters, uh-huh.
5 JUDGE BITTNER: And this was from sometime
6 in late 2002 until August of 2003?
7 THE WITNESS: It would have been 2002 to
8 2003, yes, uh-huh. Mid-2002 to mid-2003.
9 BY MS. PAREDES:
10 Q Okay. You testified that during your time
11 at ONDCP, the issue--that ONDCP became involved
12 with medical marijuana issue because there were
13 people who wanted to use medical marijuana but had
14 problems accessing it; is that accurate?
15 A Would you repeat that, please?
16 Q That ONDCP became involved with the
17 medical marijuana issue--
18 A Uh-huh.
19 Q --because there were people who wanted
20 access to it?
21 A Yes.
22 Q To use it for medical purposes?
0320
1 A Right. And also because of the
2 propositions in California and other states at the
3 time that were trying to legitimize that purpose.
4 Q Uh-huh. And what was your particular
5 involvement in terms of medical marijuana and
6 ONDCP?
7 A That's a good question. That we would
8 have tried to formulate positions for the Director
9 through the Office of Demand. That issue would
10 have come directly through the Office of Demand
11 Reduction, as it is an access issue, and so that we
12 would then, as the Director went out to speak, it
13 would be formulating his positions and also
14 crafting his speeches, his remarks for him.
15 Q And is that something that you personally
16 would have done?
17 A You know, I traveled with him on several
18 occasions and I may have written one or two of
19 those. I'd have to go back to try to clarify that.
20 And that also goes back to your issue about writing
21 on that, that there were a number of positions
0321
1 papers that I wrote in that office. I mean quite a
2 few, but on point, there may have been one or two
3 that I wrote with him about that.
4 My specific focus was on heroin and
5 cocaine, but in the course of traveling with him
6 and dealing with these issues, and as he would be
7 confronted with this by press corps, that I would
8 certainly have advised him on that.
9 Q And the "him" that you're referring to is
10 John Walters?
11 A Is General McCaffrey.
12 Q Oh.
13 A That's when that issue first came up. I
14 thought that's what you asked me, yeah, uh-huh.
15 Q Yes, that was my question. Would you have
16 had any other personal involvement aside from what
17 you've just said?
18 A No. But there was considerable discussion
19 in the office as he became more and more mired into
20 the issue and there were several lawsuits that were
21 filed against him, as I previously testified, as to
22 how he should best deal with that issue.
0322
1 Q And were you personally involved in
2 determining how he would deal with that issue?
3 A Yes, yes, with the Deputy Director at the
4 time.
5 Q And what was your involvement?
6 A He asked for, he being the Deputy Director
7 of the Office of Demand Reduction at the time, had
8 sought my advice about how best to deal with that
9 issue.
10 Q And did you provide advice?
11 A That's, I did.
12 Q Okay. And what was your advice?
13 A Is that we needed to have an objective
14 source to investigate the issue.
15 Q And is that on direct when you testified
16 that you recommended that ONDCP request the IOM to
17 study this issue?
18 A That is correct.
19 Q And you wrote a position paper or a formal
20 paper on this?
21 A You know I think it was, it was related
22 directly to the Deputy Director Fred Garcia at that
0323
1 time, and with that he went and talked with the
2 Director and the Director was immediately excited
3 about that prospect of having the Institute of
4 Medicine step in, and it removed him from the
5 firing line almost immediately.
6 Q And was that in a formal paper, your
7 recommendation, or was it informal?
8 A No, Fred Garcia then took that
9 recommendation directly to the Director.
10 Q Fred Garcia being the Deputy Director?
11 A For Demand Reduction.
12 Q Okay. And how did you convey your idea to
13 Fred Garcia?
14 A It was in a meeting with all the senior
15 policy analysts at the time.
16 Q Did you ever put that in writing?
17 A No, he took it from there. He took it.
18 Yeah. If he did, I don't recall that, but I think
19 he just took the information from there and he
20 liked the idea. He immediately grasped onto it,
21 and then the Director took it from that point.
22 Q Do you remember when this would have been?
0324
1 A It had to have been, I'm thinking in 1996.
2 Q And your position at that time would have
3 been Senior Policy Analyst?
4 A That's correct.
5 Q Before the IOM was written and produced,
6 were there any discussions at ONDCP about how they
7 would use a report, the report?
8 A That's really interesting. I don't think
9 that. I think what happened was is that the
10 interest was looking for a way out, not necessarily
11 about how it would be use, but a way out of--he had
12 become a--he being General McCaffrey--had become
13 too much of a lightning rod for that issue and the
14 lawsuits that were, you know, subsequently
15 following that, and so there really had not been--I
16 think it was is that my recollection at the time
17 is, is because of the high regard in which I think
18 all parties, from people who were interested in the
19 use for their own particular medical condition,
20 perceived use for their own particular medical
21 condition, to people who supported the use of
22 marijuana, to people who were opposed to marijuana
0325
1 for any kind of medicinal purposes, would have seen
2 the IOM as an honest broker.
3 Q So there were not any discussions on how
4 to use it?
5 A How to use the report?
6 Q Yes.
7 A I think the report was, is to, that our
8 office at that time was taking the position of let
9 us have the, you know, there may be benefits to it,
10 there may not be benefits to it, but what we want
11 to hear what the Institute of Medicine has to say
12 on point.
13 Q Okay.
14 A And I think every--and it was very well
15 received.
16 Q What was very well received?
17 A The fact that the Office was going to
18 subsidize this report, this study, by the IOM,
19 because it certainly did give us the appearance and
20 indeed and in fact that we were interested, at
21 least, in trying to gain more information about
22 whether it was efficacious or not, the study.
0326
1 Q And it was well received by whom?
2 A Well, that's what I'm saying. I think it
3 was well received by people who were looking for
4 the use of marijuana to deal with what they had,
5 medical conditions that they had, wasting
6 illnesses, HIV/AIDS, whether it was glaucoma,
7 whatever it was, that people would say, and people
8 who supported the use of medicinal marijuana and
9 people who were opposed to it all said, you know,
10 okay, we'll step back and we'll let the Institute
11 of Medicine study this point. I don't recall there
12 being any negative comments around the fact that
13 the Office said that they were going to have this
14 study. I just don't.
15 Q Referring you to Respondent's Exhibit 1,
16 page 22, the Bates stamp page 22, which is
17 recommendation two you discussed with Ms. Carpenter
18 earlier.
19 A Yes.
20 JUDGE BITTNER: I'm sorry. What page were
21 you on?
22 MS. PAREDES: Bates stamp 22.
0327
1 JUDGE BITTNER: Thank you.
2 BY MS. PAREDES:
3 Q You testified that recommendation two
4 received skepticism. Can you describe what you
5 mean by skepticism?
6 A Well, I don't--it's a hot button topic,
7 medicinal marijuana, and what we were looking for
8 at the time was a means to get off the hot spot
9 here and to have it studied. But was there going
10 to be a wholesale endorsement of the
11 recommendations that were set forth by the IOM such
12 as this one that you're asking about, number two,
13 recommendation number two, there wasn't. It had
14 been, I think if my memory serves me correctly two
15 years had passed since the study was initiated.
16 Q Well, you said that it was, this
17 particular recommendation was received with
18 skepticism. Could you explain what you mean by
19 skepticism?
20 A Well, perhaps if I said skepticism, that
21 was perhaps not the best choice of word. I think
22 it was a muted response. It was not skepticism
0328
1 that we doubt that this has application. It was
2 somewhat putting the agency, the Executive Office
3 on the spot of having to endorse it. So the
4 response was muted.
5 Q Was your section, the Demand Reduction
6 Section, tasked with reviewing the IOM?
7 A Yeah, I'm sure that it was. Yes, yes,
8 yes, yes, because that would have been the natural
9 office that it would fall to.
10 Q And did you in particular?
11 A I did review it, uh-huh, uh-huh.
12 Q Was that you by yourself or you with other
13 people?
14 A At that time, I probably had moved on to
15 doing other things, but it certainly would have,
16 and I certainly did review it at the time that it
17 came out, but I'm sure other people did as well,
18 and there was a project officer by that time that
19 had worked with them on that. So, and that person
20 probably would have had the direct responsibility
21 of providing a report about the study.
22 Q So did you review it? Did you review it
0329
1 for your own personal education or did you review
2 it for ONDCP?
3 A Well, my education, yes, but also for the
4 agency, but officially the report would have then
5 come from someone else.
6 Q Would have been reviewed by someone else
7 or?
8 A The actual report that was written, if
9 there was a report, would have been written by
10 someone else, the person who became the point
11 person to the IOM while they were going through the
12 investigation.
13 Q So then how do you know that this specific
14 recommendation, recommendation two, received a
15 muted reception?
16 A From the comments that were made about the
17 report. As I do not have the records, but I do not
18 recall. I mean there may have been a statement to
19 the effect that the ONDCP is in receipt of the
20 report and that we are, you know, having it in, you
21 know, looked into and looking at next steps, but I
22 do not recall that there was a panel that was put
0330
1 into place to look at implementation of the
2 recommendations.
3 Q Of any of the recommendations?
4 A I just don't recall that there were any,
5 there was any panel that did that.
6 Q And then referring you to page 234--
7 A Uh-huh.
8 Q --of the same document.
9 A 234?
10 Q 234, yes.
11 A Uh-huh.
12 Q The second paragraph beginning "That
13 marijuana is smoked." You testified earlier that
14 there was discussion about vaporization devices at
15 ONDCP; do you recall that?
16 A Right.
17 Q Can you explain more fully what you mean
18 by discussion?
19 A There would have been discussions around
20 the report by the policy analysts in the Office who
21 were looking at that matter, and when the, as I
22 recall, when the point was made about looking at
0331
1 vaporization or smoking, there was, as opposed to
2 the inhalation that there may have been some
3 interest around that.
4 But once again, in terms of a formal
5 establishment of a panel to look at the
6 implementation of that, I just don't recall that
7 happening.
8 Q So was there a or more than one policy
9 analyst looking at this particular issue?
10 A Yes.
11 Q Okay. Was that you?
12 A Who were the others?
13 Q Were you one of the policy analysts
14 looking at this particular issue?
15 A Looking at it, yes, uh-huh, uh-huh, uh-huh, but I
16 don't think I had the lead on it. I'm
17 pretty sure about that. At the time that as I
18 mentioned, that there was a person who was working
19 with the IOM while they were going through the
20 study, the investigation, and so that person may
21 have actually written something about it.
22 Q But to your knowledge, do you know if
0332
1 something was written about it?
2 A I just don't think there was. There could
3 have been, but I don't think that there was.
4 Q Okay. Do you know anything about the, how
5 marijuana is provided to researchers today?
6 MS. CARPENTER: Objection. Goes beyond
7 the scope of the direct.
8 MS. PAREDES: Dr. Roberts testified that
9 an alternative source of medical marijuana would
10 encourage competition.
11 JUDGE BITTNER: But I don't think she
12 actually testified to that.
13 MS. CARPENTER: She did testify to that,
14 an alternative source, but that's not--
15 JUDGE BITTNER: And I'm sorry. And the
16 question was how is it provided today?
17 MS. CARPENTER: --distribution.
18 MS. PAREDES: How is it provided today?
19 JUDGE BITTNER: Overruled.
20 BY MS. PAREDES:
21 Q Do you know how medical marijuana is
22 provided to researchers today?
0333
1 A I know that it comes from crops that are
2 grown under supervision in Mississippi through the
3 University of Mississippi.
4 Q And do you know the process by which a
5 researcher would get marijuana from Mississippi?
6 A Well, it seems that they would first have
7 to have a protocol, a research protocol that was
8 approved, and it would have had to be approved,
9 reviewed and approved by NIDA, and once that
10 process was completed and it was deemed
11 appropriate, then they would be granted the amount,
12 whatever was required in order to study.
13 Q Well, do you know how it is that medical
14 marijuana comes from the University of Mississippi?
15 A How it comes from the University of
16 Mississippi?
17 Q By what mechanism? Why is it, why does
18 medical marijuana come from University of
19 Mississippi?
20 A I gather that was through--I mean I know
21 that that relationship, that contract has been in
22 place for some time. Why the University of
0334
1 Mississippi as opposed to some other facility I
2 have no idea.
3 Q So you're aware that there's a contract?
4 A It seems like I'm aware that there is a
5 contract that exists between the two, uh-huh, the
6 two being NIDA and the University of Mississippi.
7 Q Okay. Are you familiar with Dr. Craker?
8 A I've never met him before today.
9 Q Are you currently employed?
10 A Yes.
11 Q Excuse me?
12 A Yes.
13 Q And that's with the University of
14 Georgetown?
15 A That's correct, uh-huh.
16 Q Okay. And you testified earlier that you
17 left federal employment with ONDCP, you took early
18 retirement?
19 A Yes.
20 Q And at that point, didn't you file a
21 discrimination complaint against ONDCP?
22 A That was prior to leaving.
0335
1 Q Is that complaint still pending?
2 A Oh, yeah, yeah.
3 Q Just one second, please. What were the
4 circumstances of your early retirement?
5 A It was all--
6 MS. CARPENTER: Objection as to relevance.
7 JUDGE BITTNER: Ms. Paredes, what's the
8 relevance?
9 MS. PAREDES: Her motive, her bias against
10 ONDCP.
11 JUDGE BITTNER: Overruled, but I don't
12 want to go real far with this. So, yes, would you
13 answer the question?
14 THE WITNESS: Could you repeat it?
15 BY MS. PAREDES:
16 Q What were the circumstances of your early
17 retirement?
18 A It was offered to a number of people who
19 were eligible to, who met the criteria for taking
20 it. I was not the only one. I was not the only
21 one who took it. There were several people who
22 took it. You had to meet the criteria.
0336
1 Q And the criteria is what would be commonly
2 referred to as a buy-out?
3 A Right. Absolutely. Uh-huh.
4 MS. PAREDES: Nothing further.
5 JUDGE BITTNER: Okay. Redirect?
6 MS. CARPENTER: Just a few quick
7 questions, Your Honor.
8 REDIRECT EXAMINATION
9 BY MS. CARPENTER:
10 Q Taking the last first, you testified that
11 you have an EEO claim pending against the ONDCP?
12 A That's correct.
13 Q And do you have any, are you here to
14 settle a claim, a grudge against the ONDCP?
15 A No. That work is very important that goes
16 on at ONDCP, I think, no, and the recommendation to
17 do the study, you know, I made in 1996. I'm a
18 behavioral scientist. This is dealing with the
19 merits of this situation and wouldn't have anything
20 to do with that, you know, uh-uh, with that EEO
21 complaint. That's spurious.
22 Q You testified on cross in response to a
0337
1 question about discussion at ONDCP about how they
2 would use the report. I think you testified that
3 basically ONDCP was looking for a way out of the
4 conflict that you described earlier. And I just
5 wanted to ask you to explain that a little bit
6 further. Were there positions taken by ONDP that
7 opposed medical marijuana? Is that what caused the
8 conflict or were there other issues?
9 A There is a medication on the market today,
10 Marinol, that can be given as a suppository, that
11 can be given to people who had nausea and other
12 complaints that might require its use and so that
13 was one issue.
14 The other one was that this certainly was,
15 I think at the time there was an awareness of the
16 fact that people were not, felt that there were
17 greater benefits to be gained from using different
18 portions of the plant directly, and that it was, I
19 think a matter on which the Director at the time
20 did not feel comfortable because marijuana carries
21 a lot of baggage with it.
22 And so that there was skepticism around
0338
1 the fact that certainly that, I think it was the
2 proposition in California that was passed at the
3 time, that now physicians could talk to their
4 patients about its use, and his concern, and I
5 think rightly so on this point, is that, well,
6 you're going to have people smoking a product that
7 has known carcinogens in it, and he didn't want
8 that to happen.
9 But what he was willing to do,
10 particularly because I think he was very dogmatic
11 on point, and he was looking for a way to try to
12 have some reasonable approach out of this, was to
13 look at the Institute of Medicine studying it. And
14 it would have been interesting to see had he--I
15 think about the time the report came out, he was
16 also thinking about leaving--had he remained there,
17 kind of what he would have done with that
18 information.
19 But it wasn't just an effort to say, oh,
20 well, let me slide out of this by having the
21 Institute of Medicine do it. I think he had a lot
22 of regard--McCaffrey had a great deal of regard for
0339
1 the Institute of Medicine. He felt justified in
2 his positions, but he was certainly I think willing
3 to have the Institute of Medicine, a legitimate
4 body, investigate this whole area.
5 Q Do you know if when the results came back,
6 whether it was ONDC policy to continue oppose the
7 use of marijuana as medicine or whether the policy
8 changed as a consequence IOM report which suggested
9 there were therapeutic uses?
10 A The policy really didn't change. Policy
11 really didn't change, no, uh-uh.
12 Q So the policy was still to oppose the use
13 of marijuana--
14 A Right.
15 Q --as medicine?
16 A Absolutely. Absolutely.
17 Q Okay. And if you know, and I don't know
18 if you do, but what about NIDA's policy at that
19 time? Do you know if that changed at all in
20 response to the Institute of Medicine's report?
21 A NIDA was one of the 55 or is one of the 55
22 agencies that reports status of their work in that
0340
1 area to ONDCP. So to the extent, they would have
2 looked for ONDCP's guidance, and it also being the
3 part of the Executive Office to take its lead on
4 what to do next.
5 Q So it would have been top down, whatever
6 ONDCP's policy would flow down to NIDA?
7 A It would have been top down. It would
8 have been top down.
9 Q So if ONDCP opposed the medical use of
10 marijuana, so would NIDA?
11 A You're not going to find NIDA is going to
12 jump out there and make a statement, no.
13 Q Okay. Let me just ask one other point to
14 clear up. You mentioned that there were some
15 lawsuits that were filed against Director McCaffrey
16 about this issue. Can you just briefly explain
17 what those lawsuits were about?
18 A Those, I think the fact that he was
19 impeding the privilege afforded by the proposition
20 in California to physicians to talk to patients
21 about the use of--I think they couldn't prescribe
22 it, but they would recommend its use, and he was
0341
1 opposed to that. And I think that there were
2 groups that were opposed to General McCaffrey's
3 position, so--
4 Q Okay. So--
5 A And those were the lawsuits.
6 Q Do you know whether there was any action
7 the government took to keep doctors from talking to
8 their patients about the benefits of marijuana?
9 A I think it would have been only through
10 the comments, that that was something that we did
11 not, we at the time, you know, the government did
12 not support.
13 Q Okay.
14 A In terms of an actual, you mean a
15 statement or through an Executive Order?
16 Q A rule.
17 A I don't think there was--there was no
18 Executive Order. Yeah.
19 MS. CARPENTER: All right. I have nothing
20 further.
21 JUDGE BITTNER: Recross?
22 MS. PAREDES: Yes, briefly, please.
0342
1 RECROSS EXAMINATION
2 BY MS. PAREDES:
3 Q Dr. Roberts, you testified that ONDCP and
4 NIDA were opposed to--had a policy in opposition to
5 medical marijuana. Is that accurate?
6 A Let me hear that again, please.
7 Q That the policy from ONDCP and NIDA was
8 they opposed medical marijuana?
9 A No, I said that in terms of the report,
10 that when it came out, that there was no position
11 really taken by ONDCP, and because they did not
12 take a position, you would not have expected to see
13 NIDA then to come out and take a position on the
14 IOM report.
15 Q So there was no position?
16 A No position what?
17 Q There was no position expressed on medical
18 marijuana?
19 A In terms of medical marijuana by ONDCP?
20 Q Yes.
21 A No. I think they would have said that,
22 you know, that they would have gone on record
0343
1 saying that they support the use of Marinol.
2 Q Okay. Well, has either ONDCP or NIDA, to
3 your knowledge, ever opposed medical marijuana
4 research?
5 A I don't think NIDA would oppose medical
6 marijuana research. It would not oppose it. But
7 in terms of--I don't recall a statement from NIDA
8 saying that we have reviewed the Institute of
9 Medicine report and we stand fully behind the
10 recommendations. I just don't recall ever seeing a
11 report like that.
12 MS. PAREDES: Nothing further.
13 JUDGE BITTNER: Okay. Anything else?
14 MS. CARPENTER: I'm sorry, Your Honor. I
15 just want to clear up this point because it's an
16 important one.
17 FURTHER REDIRECT EXAMINATION
18 BY MS. CARPENTER:
19 Q This issue of the policy, I think you
20 indicated that the ONDCP said they would support
21 Marinol. But the conflict that you talked about
22 that led to ONDCP being on the spot, as it were, am
0344
1 I correct that that resulted from opposition from
2 people who wanted to use marijuana for medical
3 purposes and ONDCP who did not want people to use
4 marijuana, smoke marijuana--let's be clear about
5 that--for medical purposes?
6 A That there was no efficacy for its use.
7 That is correct.
8 Q Okay. So that was what created the
9 conflict? ONDCP did not want people to use smoked
10 marijuana for medical purposes?
11 A That is correct.
12 MS. CARPENTER: Okay.
13 THE WITNESS: That is correct.
14 JUDGE BITTNER: Anything else, Ms.
15 Paredes?
16 MS. PAREDES: Yes.
17 FURTHER RECROSS EXAMINATION
18 BY MS. PAREDES:
19 Q To your knowledge, is using smoking
20 marijuana for medical purposes, is that a legal
21 activity?
22 A Is smoking marijuana for?
0345
1 Q For any purpose.
2 A Is it a legal activity?
3 JUDGE BITTNER: Is it a legal, the
4 article, not illegal? Okay.
5 MS. PAREDES: Correct. Is it a?
6 JUDGE BITTNER: Is it legal to smoke
7 marijuana for treatment of a disorder?
8 THE WITNESS: Thank you. I think if it's,
9 once again, I would stand on the science. If it
10 has been deemed medically indicated and it was
11 buttressed by research.
12 JUDGE BITTNER: No, I think the question
13 is, well, Ms. Paredes, I'll ask you to phrase the
14 question.
15 BY MS. PAREDES:
16 Q Can you repeat your answer, please?
17 A I said if it has been deemed medically
18 efficacious and buttressed by research, then I
19 would support it.
20 JUDGE BITTNER: I think the question
21 wasn't what you would support, but what it is?
22 What's the--
0346
1 BY MS. PAREDES:
2 Q Do you know the state of the law today
3 with regard to the use of marijuana?
4 A It's illegal.
5 Q Are you certain that ONDCP has a policy, a
6 stated policy, that they're opposed to medical
7 marijuana?
8 A You mean is there a written policy?
9 Q Yes.
10 A Oh, no. No.
11 MS. PAREDES: Nothing further.
12 JUDGE BITTNER: Okay.
13 MS. CARPENTER: I'm sorry to do this,
14 Judge, but one more question.
15 JUDGE BITTNER: That's all right. I'm
16 here all day.
17 FURTHER REDIRECT EXAMINATION
18 BY MS. CARPENTER:
19 Q If there was an FDA approved protocol--
20 A Uh-huh.
21 Q --for smoking marijuana as part of
22 clinical research, would that be a legal use?
0347
1 JUDGE BITTNER: The problem is the word "a
2 legal," the two words "a legal," and the one word
3 "illegal."
4 MS. CARPENTER: Would that be a--would it
5 be legal--right. Exactly.
6 JUDGE BITTNER: Okay. Which do you mean?
7 BY MS. CARPENTER:
8 Q Would it be legal to smoke marijuana in an
9 FDA approved protocol testing medical marijuana?
10 A Absolutely, yes, yes, yes. That's the
11 only way you're going to make the determination
12 about its efficacy.
13 MS. CARPENTER: Thank you.
14 JUDGE BITTNER: Okay. Are you done?
15 MS. CARPENTER: I am.
16 JUDGE BITTNER: Ms. Paredes, are you?
17 Yes, no? Okay. Then, Dr. Roberts, so are you.
18 Thank you for coming.
19 Would you all like to take a lunch break?
20 Let's go off the record.
21 [Discussion held off the record.]
22 JUDGE BITTNER: Back on the record. We
0348
1 will take a luncheon recess until a quarter to two.
2 Off the record.
3 [Whereupon, at 12:35 p.m., the hearing
4 recessed, to be reconvened at 1:45 p.m., this same
5 day.]
0349
1 A F T E R N O O N S E S S I O N
2 [1:50 p.m.]
3 JUDGE BITTNER: Are we ready for the
4 cross-examination of Dr. Craker?
5 MS. CARPENTER: The redirect examination,
6 Your Honor.
7 JUDGE BITTNER: I'm sorry?
8 MS. CARPENTER: For the redirect
9 examination, I believe. We finished cross this
10 morning.
11 MR. BAYLY: Of Dr. Craker.
12 JUDGE BITTNER: Did we?
13 MS. CARPENTER: Of Dr. Craker.
14 JUDGE BITTNER: Good grief!
15 [Laughter.]
16 JUDGE BITTNER: I'm sorry; yes, let's call
17 it redirect.
18 MS. CARPENTER: It's all been interrupted.
19 [Laughter.]
20 JUDGE BITTNER: That is okay. I do better
21 when I'm reading the transcript.
22 [Laughter.]
0350
1 MS. CARPENTER: That's perfectly all
2 right.
3 JUDGE BITTNER: All right; Dr. Craker,
4 would you resume the stand, please? Have you
5 developed anything for early onset Alzheimer's?
6 [Laughter.]
7 Whereupon,
8 LYLE CRAKER
9 was recalled as a witness herein and, having been
10 previously duly sworn, was examined and testified
11 further as follows:
12 JUDGE BITTNER: Would you repeat your name
13 for the reporter, since we have a new reporter?
14 THE WITNESS: My name is Lyle Craker.
15 JUDGE BITTNER: Okay.
16 MS. CARPENTER: All right?
17 REDIRECT EXAMINATION
18 BY MS. CARPENTER:
19 Q Dr. Craker, if you would turn first to
20 Government's Exhibit No. 3, which I'm not sure is
21 up there or not, and actually, could we get
22 Government's Exhibit No. 2 at the same time to save
0351
1 some steps?
2 A Thank you.
3 Q Now, you were asked a lot of questions
4 about Government's Exhibit No. 2 and 3, in
5 particular with regard to Government's Exhibit No.
6 3 and some of the information that you produced.
7 And I just wanted to talk a little bit about how
8 all this happened.
9 You indicated first, just a little
10 background, but Dr. Doblin had approached you and
11 talked about developing a place to grow marijuana.
12 Did Dr. Doblin assist you in drafting this? Did
13 you talk with him in consultation about drafting
14 the application or the answers to the questions?
15 A On Exhibit No. 2?
16 Q Exhibit No. 2 and Exhibit No. 3.
17 A And Exhibit No. 3?
18 Q Right.
19 A Certainly, Dr. Doblin told me about the
20 need for the application. I do not remember; we
21 did not sit down together and go through this.
22 Q When the questions came in from the DEA,
0352
1 did you have a conversation with him about those
2 questions?
3 A Yes, I did have a conversation with Dr.
4 Doblin, and he assisted in the response to the bulk
5 manufacturer's questions.
6 Q Okay; and so, question number one, for
7 example, I think some of the questions that Mr.
8 Bayly asked you, for example; he asked you if you
9 knew that there was--if you knew that there was
10 just one cultivator, and I think you said yes, and
11 then asked the rationale for why you needed more
12 cultivators. Did you receive information from Dr.
13 Doblin that led you to that conclusion?
14 A Yes.
15 Q And had you talked with Dr. Doblin about
16 the issue of availability of medical marijuana?
17 A Yes, we covered lots of talks about those
18 types of issues, yes.
19 Q Okay; and did you think or have reason to
20 believe at the time that he had talked to other
21 researchers about these issues?
22 A Well, yes, I felt that that--in a way, I
0353
1 don't remember him telling me exactly that he had
2 talked to other researchers, but certainly, I
3 understood that.
4 Q Okay; did he indicate to you that he had,
5 you know, gotten information about quality issues
6 from dealing with other researchers?
7 A Yes.
8 MR. BAYLY: Your Honor, excuse me, but
9 we're getting into the leading area here.
10 JUDGE BITTNER: Yes, I think it is a
11 little leading.
12 MS. CARPENTER: I will try and refrain. I
13 was trying to cut through a little bit of--
14 MR. BAYLY: If we could strike that answer
15 and then start again, please.
16 JUDGE BITTNER: Well, let's just go to the
17 question to which there was an objection, so let's
18 rephrase that one.
19 MS. CARPENTER: All right.
20 BY MS. CARPENTER:
21 Q What sort of issues did he talk with you
22 about?
0354
1 A Well, Dr. Doblin talked with me about--when we
2 initially talked about this thing, the need
3 for an alternative source to the NIDA material, and
4 at that time, he indicated to me that there were
5 reports of quality problems and that there was only
6 the one source.
7 Q Okay; and so, when Mr. Bayly asked you
8 about your individual contacts with particular
9 researchers, you indicated that you hadn't had at
10 least specific ones that you recalled. But what
11 contacts did you rely on when you wrote the answers
12 in Government Exhibit No. 3?
13 A Well, primarily, I relied on the material--
14 discussions with Dr. Doblin.
15 Q Okay; now, you were asked a series of
16 questions about security requirements.
17 A Yes.
18 Q And the cost of that.
19 A Yes.
20 Q And I think you indicated in your direct
21 that there were several visits from DEA agents to
22 the facility. In those discussions, were there
0355
1 general talks about the need for security?
2 A Well, from the Federal Government, I think
3 I've said what they required and that they were
4 looking for a facility that was protected by the--
5 essentially partly underground--but they came and
6 looked at the room we had proposed growing the
7 material in, and from all indications I had, they
8 thought that was satisfactory.
9 Q Okay; and has the DEA said when they'll
10 let you know about what other specific requirements
11 for security, what they might be?
12 A No.
13 Q You were also asked a series of questions
14 about how, should you be issued the registration,
15 how marijuana that you would grow would be
16 distributed, would be provided. And I guess my
17 first question to you is what's the first thing you
18 had to do in order to start this whole process?
19 A The first thing I had to do to what?
20 Q To start this whole process; that is, did
21 you have a full blown plan in place before you ever
22 applied for the license, or did you see applying
0356
1 for the license as the first step?
2 A No, I did not have a full blown plan when
3 we applied for the license, because everything
4 after that depended on getting the license.
5 Q Did you expect to develop it--
6 A Time is valuable.
7 Q Okay; and by that, what do you mean?
8 A Well, I mean that unless we get the
9 license, it doesn't pay to plan much further ahead,
10 and that would essentially be a waste of time.
11 Q Okay; so, do you think--how do you think
12 these issues will be worked out once the license is
13 granted, assuming--
14 A Well, I think that once the license is
15 granted and funding is secured, we will move ahead
16 very rapidly.
17 Q You were also asked a series of questions,
18 I think, about who the potential researchers might
19 be. Is it your understanding--well, let me just
20 ask you this: do you currently have a contract
21 with MAPS?
22 A No, I don't.
0357
1 Q Is there one being negotiated or worked
2 on?
3 A I had supplied Dr. Doblin with the general
4 contract that the university uses.
5 Q Okay; and you expect that that will sort
6 of define the relationship between the two parties?
7 A I think it will define the relationship as
8 far as the university is concerned. The
9 university, of course, does negotiate contracts,
10 and so, there may be changes in the contract.
11 Q Okay; you were also asked some questions
12 about whether you had had any correspondence or
13 talks with pharmaceutical drug companies. Do you
14 remember those questions?
15 A Yes.
16 Q And I think the answer was no.
17 A Yes.
18 Q And is it your understanding that although
19 MAPS may not be a pharmaceutical drug company, is
20 it your understanding that they are looking to
21 marijuana into FDA-approved medicine?
22 MR. BAYLY: Objection, leading.
0358
1 JUDGE BITTNER: Yes.
2 MS. CARPENTER: I'm sorry, Your Honor.
3 JUDGE BITTNER: Let's rephrase that one.
4 It's okay.
5 MS. CARPENTER: I'll rephrase.
6 JUDGE BITTNER: You can go slow. We're
7 here.
8 MS. CARPENTER: Yes.
9 JUDGE BITTNER: We're not going anywhere.
10 [Laughter.]
11 BY MS. CARPENTER:
12 Q What is your understanding of what MAPS is
13 trying to do through its work in sponsoring
14 researchers and in sponsoring your work?
15 A Well, in conversations with Dr. Doblin, my
16 understanding is that my role would be to produce
17 the plant material and that MAPS would do the
18 contact with the investigators and would then--the
19 exact details are not worked out, but essentially
20 route them to us for the supply of the material.
21 JUDGE BITTNER: And when you say
22 investigators, are you referring to investigators
0359
1 who are using in research?
2 THE WITNESS: Yes.
3 JUDGE BITTNER: Not enforcement
4 investigators.
5 THE WITNESS: Yes.
6 BY MS. CARPENTER:
7 Q Medical investigators.
8 A Medical investigators, yes.
9 Q And a similar question with regard to--we
10 talked earlier about the vaporizer.
11 A Yes.
12 Q And what is your understanding of--what
13 would your role in that be in terms of vaporization
14 development?
15 A Having a supply available.
16 Q And to whom would it go?
17 A My understanding is that I know that MAPS
18 has been doing research related to the vaporizer,
19 and I understand that they need a source of
20 marijuana for testing this vaporizer is my
21 understanding and that part of the material that we
22 produced would go towards this.
0360
1 Q Okay; and who would you look to to tell
2 you what's necessary for that research?
3 A Well, I would initially--
4 Q For that material, not for the research.
5 A Right.
6 Q But who would you look toward for to--
7 A Well, I would suspect that the first
8 indication of what would be needed would come
9 through MAPS.
10 Q Okay; now, you were asked some questions
11 about whether since, as Mr. Bayly said, there were
12 no pharmaceutical companies or researchers that
13 you, yourself, knew of, that he asked you whether
14 you would commence to grow the marijuana, and you
15 indicated, I think, correct me if I'm wrong, that
16 you would sort of check the system to sort of make
17 sure that everything worked; is that accurate?
18 MR. BAYLY: Objection; leading.
19 JUDGE BITTNER: Sustained.
20 BY MS. CARPENTER:
21 Q You were asked some questions on cross-examination
22 about whether you would start to grow
0361
1 the marijuana when you got the license. Do you
2 recall that question?
3 A Yes, I do.
4 Q Would part of your determination about
5 when to grow that marijuana, what would go into
6 that determination?
7 A Well, as I've indicated, the facility
8 would need to be tested to see if everything
9 worked, and we would certainly want to do that
10 before we started to produce any for possible
11 clinical trials or testing in any way. After that,
12 it would depend upon whether we had any firm orders
13 for the marijuana. I can see no use in growing it
14 if there wasn't some.
15 Q And if MAPS made a firm order, would that
16 be sufficient?
17 A That would be sufficient.
18 Q Okay; and what's your understanding of the
19 process that any particular marijuana you would
20 raise--I'm not talking about the technical process,
21 but would there be testing involved with marijuana
22 that you would raise that would be needed to be
0362
1 done before it could be used for clinical purposes?
2 A You mean testing for the constituents?
3 Q Could be, or for any other--
4 A There may be a need for that, but I think
5 that would depend upon who was the--and I think we
6 discussed that earlier. It depends on the--I guess
7 we could call them the customer for the material.
8 Q And if the customer was a Federal agency
9 that was going to approve or disapprove use of a
10 particular project, that would be--
11 A We could do that then, yes.
12 Q You were also asked a series of questions
13 about whether you knew particular researchers who
14 would need marijuana in a particular potency range,
15 and let me draw your attention to Government's
16 Exhibit No. 3, page 3. Do you see at the top of
17 the page, to ensure researchers a range of potency
18 from about 7 to 15 percent THC?
19 A On page 1?
20 Q Page 3; I'm sorry.
21 A Page 3? And where are you looking?
22 Q The first sentence there.
0363
1 A Okay; to all material?
2 Q No, it starts to ensure researchers.
3 MR. BAYLY: It starts at the bottom of
4 page 2.
5 BY MS. CARPENTER:
6 Q Right; it starts at the bottom of page 2;
7 I apologize. This amount would be from several
8 different strains to ensure researchers a range of
9 potency from--
10 A Yes.
11 Q Sorry, from about 7 to 15 percent THC.
12 And then, it goes on to say all material will go on
13 to be distributed to Federally-approved
14 researchers. And again, did some of this
15 information come from Dr. Doblin?
16 A This information came from Dr. Doblin.
17 Q You were asked a series of questions about
18 smoked versus nonsmoked.
19 A Yes.
20 Q And I think you indicated a personal
21 preference for nonsmoked. Is your understanding of
22 your agreement with MAPS that you will provide
0364
1 marijuana for FDA-approved research or for
2 something else?
3 A No, only for FDA-approved research. I was
4 going to say, in reference to the--and I understand
5 that this would not be smoked, but we have to leave
6 in the smoked, I think, in case there needs to be
7 comparisons made between smoked and nonsmoked
8 material. So I don't think we can eliminate--I
9 would be afraid to eliminate it entirely.
10 Q And if the FDA-approved protocol called
11 for smoked marijuana, is that what you would
12 provide?
13 A Yes.
14 Q I think you were asked some questions
15 about whether you had heard of complaints from
16 particular researchers, and you indicated that Dr.
17 Russo had done a seminar.
18 A Yes.
19 Q At the University of Massachusetts.
20 A Yes.
21 Q Do you recall the subject of that seminar?
22 A It had to do with--I recall the subject
0365
1 had to do with marijuana and the need for research.
2 I guess his struggles to do research, but that's
3 only in general. I cannot remember the exact
4 details other than that.
5 Q And when you say marijuana, are you
6 talking about medical marijuana?
7 A Medical marijuana, yes.
8 Q All right.
9 A Please.
10 Q And based on that, did you understand him
11 to be a researcher?
12 A My understanding was that he was
13 interested in researching this, yes.
14 Q You were also asked a series of questions
15 on cross-examination about the bid for the next
16 NIDA contract.
17 A Yes.
18 Q Was it your intent when you filed this
19 application to replace NIDA as a supplier?
20 A No, not at all.
21 Q What was your intent?
22 A Our intent was to have an alternative
0366
1 supply available.
2 Q All right; and why would you want to
3 provide an alternative supply?
4 A Well, I think an alternative supply was
5 necessary in my mind because the current research
6 was being--a couple of reasons, I think. The
7 current research was being controlled by the
8 Government, because they can choose who they gave
9 the material to to influence the research, and
10 secondly, in science, we don't go by one thing. We
11 have replicated by different investigators whether
12 things work or not, and that's certainly a
13 principle I adhere to.
14 Q Okay; I think you were also asked some
15 questions about your experience in providing
16 security for plants.
17 A Yes.
18 Q And you indicated that your work when you
19 were at Fort Dietrich, Maryland--
20 A Yes.
21 Q --was secret; was that classified work?
22 A Yes, classified.
0367
1 Q And were there restrictions on what you
2 could do while at the laboratory? Were security
3 systems in place while you were at the laboratory?
4 A There were security systems in place
5 similar to the security you have in this building.
6 Q Okay; so you're familiar with how those
7 work?
8 A Yes.
9 Q Do you recognize the importance of that
10 sort of security in a situation like this
11 registration application?
12 A Yes.
13 Q Now, the Government, if I could ask you to
14 turn to Government's Exhibit No. 30.
15 A Yes.
16 Q Okay; and I think you were asked a series
17 of questions about particularly an article
18 involving Dr. Israelski.
19 A Yes.
20 Q Well, let me just, before I get there,
21 with regard to this letter, did you also consult
22 with Dr. Doblin as you worked on the response to
0368
1 the DEA's questions?
2 A To be honest with you, I cannot recall
3 whether I did or not.
4 Q Do you think it's likely that you did?
5 Were you consulting with--
6 A Well, yes, I think it is likely that I
7 probably did consult with him. I have generally
8 tried to keep him informed of all material.
9 Q Okay; so in paragraph number two, the
10 references to private conversations that I think
11 you had some questions about on cross-examination,
12 is it possible that information came from Dr.
13 Doblin? I'm sorry; let me just be a little bit
14 more clear about that. You had been asked some
15 questions about the first sentence of that
16 statement.
17 A Yes.
18 Q Of that paragraph, and while I recognize
19 that the primary researchers receiving plant
20 material may openly state to you that they are
21 satisfied with the current source, I am sure that
22 you appreciate that in private conversations, these
0369
1 same researchers indicate a fear of having the
2 current supply eliminated if they complain about
3 the available source. Is it likely or possible
4 that information came--
5 A Well, certainly, some of that came from
6 Dr. Doblin.
7 Q As well as other sources?
8 A As well as other sources, and I heard that
9 at a conference I attended.
10 MS. CARPENTER: Okay; Your Honor, there
11 was some discussion about whether the letter
12 attached, the Government's Exhibit that was shown
13 was the letter that was actually attached. I think
14 that we have ascertained that it is, and I would
15 offer it to make this letter record complete, if
16 that is helpful for sort of completeness of the
17 record.
18 JUDGE BITTNER: Although there is also
19 another attachment.
20 MS. CARPENTER: There is, which we don't
21 have, and the Government--
22 JUDGE BITTNER: Okay.
0370
1 MS. CARPENTER: --doesn't have either.
2 JUDGE BITTNER: Mr. Bayly?
3 MR. BAYLY: That's fine; absolutely. Let
4 it in.
5 MS. CARPENTER: So it's not numbered.
6 Should we make it a Respondent's Exhibit?
7 MR. BAYLY: Could we just append it to
8 Government's Exhibit No. 30 as--
9 JUDGE BITTNER: Let's call it 30A.
10 MS. CARPENTER: 30A?
11 MR. BAYLY: 30A?
12 JUDGE BITTNER: Yes.
13 MR. BAYLY: Okay. Now, I don't have a
14 copy of it.
15 [Laughter.]
16 JUDGE BITTNER: I don't, either. We need
17 to make copies. Do you happen to have a copy for
18 me for any chance? I think our photocopying
19 machine is up to making one copy.
20 MR. BAYLY: Did I give you one, Judge
21 Bittner?
22 JUDGE BITTNER: I gave it back to you.
0371
1 MR. BAYLY: Uh-oh. That was your mistake.
2 [Laughter.]
3 MR. BAYLY: It went into my black hole
4 here.
5 JUDGE BITTNER: Okay; why don't we make a
6 copy of it?
7 MR. BAYLY: No, I take it back.
8 JUDGE BITTNER: Okay.
9 MR. BAYLY: I pulled it out of a black
10 hole.
11 JUDGE BITTNER: It can go into my memory
12 instead.
13 [Laughter.]
14 MR. BAYLY: I'll give you the one with the
15 yellow stick-em, and we can just mark that.
16 JUDGE BITTNER: Oh, no, that will confuse
17 the issue. Then, I'll think I can't write on it.
18 Okay; so that's the official copy, and that's 30A.
19 And now, do you have a copy for me?
20 MR. BAYLY: Oh, you need a copy?
21 JUDGE BITTNER: Right.
22 MR. BAYLY: No.
0372
1 [Laughter.]
2 JUDGE BITTNER: We'll make a copy. We can
3 make a copy of it. But let me just take a look at
4 it.
5 Do I correctly assume that this should be
6 offered without the underlinings?
7 MS. CARPENTER: I assume so.
8 JUDGE BITTNER: I assume that they weren't
9 in whatever was received by Mr. Sapienza?
10 MR. BAYLY: Yes, that is correct, Judge.
11 JUDGE BITTNER: Okay.
12 MR. BAYLY: Is your clerk's copy also--
13 JUDGE BITTNER: Yes, I'm not worried about
14 the underlinings. I just want to know whether
15 they're--okay, they're not.
16 MR. BAYLY: Well, can we say for the
17 record that they shouldn't be there?
18 JUDGE BITTNER: Right.
19 MR. BAYLY: That they should--
20 JUDGE BITTNER: Okay; yes; 30A is
21 received.
22 [Government's Exhibit No. 30A
0373
1 was marked for identification
2 and received in evidence.]
3 BY MS. CARPENTER:
4 Q Do you have a copy, Dr. Craker?
5 A No.
6 JUDGE BITTNER: How about I give you--oh,
7 okay.
8 THE WITNESS: Thank you.
9 BY MS. CARPENTER:
10 Q And I'll give you just a minute to look at
11 that, although you certainly looked at it earlier
12 today.
13 A Yes.
14 Q And again, looking at Government's Exhibit
15 No. 30 and the third paragraph, the first sentence,
16 to illustrate the problem of quality--
17 A Yes.
18 Q --I have enclosed copies of two documents
19 for your review, both of which I know you are
20 familiar, parentheses, the letter you received from
21 Dr. Russo and an article from the San Mateo County
22 Times, et cetera. The article that was attached,
0374
1 that we have all now agreed is Government's Exhibit
2 No. 30A without the underlinings, does that article
3 illustrate the problem of quality with regard to
4 cigarettes from NIDA?
5 MR. BAYLY: Objection, leading.
6 JUDGE BITTNER: I'll allow it.
7 MS. CARPENTER: Thank you, Your Honor.
8 THE WITNESS: The article certainly
9 represented to me the problem with quality.
10 BY MS. CARPENTER:
11 Q And did you intend--do you think your
12 letter to Mr. Sapienza indicates that Dr. Israelski
13 in particular was concerned about the quality, or
14 was he just quoted in the article?
15 A I did not understand the last part of your
16 question.
17 Q I don't blame you. It was a complicated
18 question. In your letter--
19 A Yes.
20 Q --to Mr. Frank Sapienza, when you noted in
21 parentheses that Dr. Israelski was quoted--
22 A Yes.
0375
1 Q --were you representing there that he was
2 quoted as specifically condemning NIDA marijuana or
3 just that the article was about the quality of it?
4 A Well, we can immediately see that there is
5 no direct quote from him, so I think that there are
6 a couple of things here. First, we have the
7 general tone of the article is very titled:
8 doctors want better marijuana for study. Dr.
9 Israelski was, I suspected, picked on or cited in
10 my letter because of his association. He is the
11 first one listed there.
12 It probably should have been--maybe
13 quoting was wrong; should have been about; I don't
14 know.
15 Q Well let me just point your attention to
16 the very last paragraph of the article.
17 A Yes.
18 Q Is there not a quote there from Dr.
19 Israelski?
20 A There is, I guess. Also a need for a
21 nonsmokable form of marijuana for pain relief from
22 chronic disease.
0376
1 Q Well, I was talking about the very last
2 paragraph, which begins Israelski, medical director
3 of this study. Oh, yes, that's exactly the one you
4 just read, yes. And then it says the county is
5 well positioned to lead in this effort.
6 A I'm sorry.
7 Q So just to be clear, there is a quote from
8 Dr. Israelski in the article.
9 A Yes, there is a quote from him there, yes.
10 MS. CARPENTER: Okay; that's all.
11 Your Honor, we don't have, or I guess we
12 do have a copy of the Russo letter, but only on the
13 computer. And I was wondering for completeness
14 sake if we could also include--get a copy of the
15 Russo letter and attach it to the letter as well so
16 that it will be complete as a--
17 JUDGE BITTNER: As long as you can reach
18 agreement that that's what it is.
19 MS. CARPENTER: Yes.
20 JUDGE BITTNER: But I guess Mr. Bayly
21 can't do that until he can see it.
22 MS. CARPENTER: Right.
0377
1 MR. BAYLY: No, I can't answer that right
2 now. I don't think we have a copy available and--
3 MS. CARPENTER: I'm happy to do that at a
4 later date. I don't want to ask questions.
5 JUDGE BITTNER: Right.
6 MS. CARPENTER: I just want to make that--
7 JUDGE BITTNER: Okay.
8 MS. CARPENTER: --document complete.
9 MR. BAYLY: If someone would like to
10 remind me about this issue, we can look at it at a
11 later time.
12 MS. CARPENTER: Right.
13 MR. BAYLY: But right now--
14 JUDGE BITTNER: Okay.
15 MR. BAYLY: --I don't have it.
16 JUDGE BITTNER: Sure.
17 MS. CARPENTER: All right; I think that's
18 all we have, Your Honor.
19 JUDGE BITTNER: Okay; redirect.
20 MR. BAYLY: Yes, thanks, Judge Bittner.
21 RECROSS EXAMINATION
22 BY MR. BAYLY:
0378
1 Q Dr. Craker--
2 JUDGE BITTNER: Recross.
3 BY MR. BAYLY:
4 Q You've still got both these exhibits,
5 Government 3 and 30 up there.
6 A I have Government 30 and 30A.
7 Q You don't have the questions in Exhibit
8 No. 3?
9 A No, I do not.
10 Q Thank you.
11 A Now, I have Government Document 3.
12 Q You've indicated, Dr. Craker, that Dr.
13 Doblin helped you fill these questions out on
14 Exhibit No. 3, the response to bulk manufacturing
15 questions.
16 A Yes.
17 Q What I want to try to find out is the
18 extent that helped you with these questions. Did
19 he supply a rough draft for you to answer these
20 questions?
21 A That could well be. Again, we're talking
22 about something that's quite old, and I can't
0379
1 remember everything, but he may very well have
2 supplied a rough draft for me. Certainly, this, as
3 I recall, was probably done by email. I think that
4 I, as I recall, indicated to him that I had gotten
5 a question from the DEA, and I probably sent those
6 to him at that time, and I suspect knowing Dr.
7 Doblin, he probably sent me back his proposed
8 answer for each of the questions.
9 Q All right; and then, do you recall if you
10 made any substantial changes to the email drafts
11 that you received from Dr. Doblin?
12 A I teach a class in editing, and there is
13 no paper that passes my desk without some red ink
14 changes on it. Substantial, I don't know what we
15 can call substantial but--
16 Q Well, I understand, Dr. Craker, so let's
17 maybe look at this in a little bit more detail--
18 A Sure.
19 Q --so I can give you some more specifics.
20 Under paragraph one, question one, paragraph two,
21 it says MAPS is seeking to develop the marijuana
22 plant into an FDA-approved prescription medicine.
0380
1 I imagine that is something that Dr. Doblin
2 indicated that he would want in this response?
3 A That may very well be.
4 Q And MAPS will sponsor research at other
5 institutions using smoked marijuana and marijuana
6 delivered through a vaporizer. That's the last
7 sentence there.
8 A Yes, I see the sentence.
9 Q That one was supplied by Dr. Doblin.
10 A I have no idea--I could not define the
11 authorship of that sentence. It may be.
12 Q I'm sorry, Dr. Craker. Go ahead and
13 finish.
14 A I said it may be, and it may not be. And
15 it may be partially his. I cannot identify the
16 author of each sentence or the wording of each
17 sentence.
18 Q Well, would it be safe to say that Dr.
19 Doblin supplied this sentence to you because
20 without him, you would have had no knowledge that
21 there was a vaporizer device that would heat up the
22 marijuana for use?
0381
1 A Well, we had talked about the--he had
2 talked about marijuana research with me before this
3 memorandum was written.
4 Q All right; Dr. Craker, let me just
5 digress: are you aware of the company that's doing
6 this vaporizer research? Do you know the company's
7 name?
8 A No.
9 MS. CARPENTER: Objection, asked and
10 answered several times.
11 JUDGE BITTNER: Not quite that way,
12 actually. Overruled.
13 THE WITNESS: No, I do not.
14 BY MR. BAYLY:
15 Q So nobody--Dr. Doblin or no one from MAPS
16 has ever told you who this company is?
17 A If they have, I haven't paid any
18 attention. It was of little relevance to me at the
19 time. If it was discussed, there was little
20 relevance. I do not recall ever having it
21 discussed with me.
22 Q Okay; then, you would have no idea of the
0382
1 legal status of this company, whether it is
2 entitled to receive marijuana under Federal law.
3 A That's true; that's true.
4 MS. CARPENTER: If I could just--I have
5 some objection to characterizing the notion that
6 they're talking about a specific company here. I
7 mean, as I read it, it says will sponsor research
8 at other institutions. I don't think it makes
9 reference to a particular company. I could have
10 missed something.
11 MR. BAYLY: Yes, I think that can be
12 picked up on redirect, Judge Bittner.
13 MS. CARPENTER: Sorry.
14 JUDGE BITTNER: Well, no, but if the
15 question assumes a fact not in evidence, it's a
16 proper objection, so we'll just leave it right
17 there.
18 BY MR. BAYLY:
19 Q Dr. Craker, let's drop down to question
20 number two on these--
21 A Certainly.
22 Q --Government Exhibit No. 3. It talks
0383
1 about--it asks please describe the production
2 process for these controlled substances from start
3 to finish.
4 A Yes.
5 Q Would you say that answer is yours or Dr.
6 Doblin's?
7 A Well, I would say that it probably is
8 predominantly mine.
9 Q Let's go all the way to question number
10 six.
11 A Yes.
12 Q Okay; you say the goal for the first year
13 is a maximum of 25 pounds dry weight. Do you know
14 whose answer that would be? Would that be yours?
15 A That would be Dr. Doblin's. He would give
16 me that number.
17 Q Okay; and do you know on what basis he
18 came up with that number?
19 A Well, I assume he has contact with--I
20 mean, that was my assumption that he had contact
21 with potential customers, if we can use that term
22 again and would have some idea of what would be
0384
1 needed.
2 Q Okay; but you've never found out who those
3 potential customers were.
4 A I did not, no.
5 Q Now, you indicated in your conversations
6 with Dr. Doblin that he had some--he related some
7 quality problems to you about the University of
8 Mississippi's marijuana; is that correct?
9 A Yes.
10 Q Did he tell you what kind of quality
11 problems?
12 A Ones that I've indicated before, that the
13 material contained extraneous material.
14 Q I'm sorry?
15 A It contained extraneous material.
16 Q And you don't know if that's been
17 addressed or not by the University of Mississippi.
18 A I have no idea.
19 Q Any other kind of quality problems?
20 A Quality, if we're referring to the level
21 of constituents, then, it had a low constituent
22 level.
0385
1 Q When you say low constituent level, are
2 you talking about THC?
3 A Yes.
4 Q Okay; and did he tell you who had these
5 problems?
6 A Not that I recall.
7 Q And can you tell us roughly, and I
8 certainly am not going to hold you to any dates,
9 when you had this conversation with Dr. Doblin?
10 A I suspect that some of the initial
11 conversations were held when I first met with Dr.
12 Doblin. How much they were discussed in detail, I
13 have no idea. But certainly, at the time, I would
14 have had to have been convinced of the necessity of
15 doing this.
16 Q Dr. Craker, when was the last time that
17 you can recall that Dr. Doblin related any kinds of
18 problems with the quality of the University of
19 Mississippi marijuana?
20 A I have no idea. I do not think we have
21 talked about it this year.
22 Q All right; so it hasn't been recent, then?
0386
1 A Well, I don't know what recent is; we've
2 been talking about five years here.
3 Q Within the last year.
4 A I don't believe we have. But January was
5 a long time ago also.
6 Q Now, MAPS itself is not a registered DEA
7 entity, right?
8 A I have no idea.
9 Q Do you know if MAPS is authorized to
10 physically take marijuana, say, from you if you
11 were registered, to a researcher?
12 A I do not believe so, and that was not the
13 intention. The intention is I would ship the
14 material directly to the investigator, using the
15 term again.
16 Q I think Ms. Carpenter asked you if you
17 attended a conference with Dr. Russo. Would you be
18 able to tell us when that conference occurred?
19 A Conferences meld together with me because
20 I attend so many, but I think it was in 2004.
21 Q And would it be your intent to pursue this
22 application even if you knew that the University of
0387
1 Mississippi supplied an adequate quantity and
2 quality of marijuana to researchers?
3 A Well, the answer to that is yes, because
4 we're talking, we're still talking about a
5 government control of who gets to do the research
6 as far as I can see. And secondly, with only that
7 source, we're eliminating any secondary source that
8 could be used for comparison purposes.
9 Q Well, you say government control, but, I
10 mean, if you're registered, you will be government
11 controlled as well.
12 A Yes, you're right, to a certain extent.
13 Maybe to a large extent.
14 Q But are you saying, then, you want--what
15 difference would it be, then, between the
16 government controls if you're both registered, if
17 you know?
18 A Well, my understanding is that Mississippi
19 is under a government contract. Our work would
20 certainly not be under a government contract. With
21 a government contract, they can supply to who the
22 government decided what experiments were relevant
0388
1 to various investigators. In our case, we would
2 offer a competitive source and could be supplied to
3 investigators that were licensed to do the studies.
4 Q So you say a government contract. A
5 government contract; let's define government here--
6 A Yes.
7 Q --is with NIDA, right?
8 A Yes.
9 Q And that's a division or branch of HHS.
10 A Yes, I guess.
11 Q So DEA would have nothing to do with this
12 contract, to the best of your knowledge?
13 A I have no idea what the flow chart looks
14 like for NIDA or DEA.
15 Q If we could take a look at Government
16 Exhibit No. 30, Dr. Craker.
17 A Sure.
18 Q Did Dr. Doblin supply you with the article
19 from the San Mateo County Times that we have now
20 marked as Government Exhibit No. 30A?
21 A I honestly do not recall.
22 Q Don't know where that came from?
0389
1 A I have no idea where that came from
2 currently, no.
3 Q And the same response for the letter from
4 Dr. Russo that's referenced in this letter?
5 A Whether that was supplied by Dr. Doblin or
6 by Dr. Russo to me, I do not know.
7 Q But the information in paragraph two, and
8 it starts out--
9 A Yes.
10 Q --while I recognize, that whole paragraph
11 there is not something you came up with, but that
12 was information supplied by Dr. Doblin?
13 A Well, certainly, the initial conversations
14 along this line came from Dr. Doblin. But as I
15 indicated to you also earlier, that once we
16 applied, and this got into the public domain
17 through various newspapers and radio stations, I
18 received emails along this line indicating a
19 similar type of things.
20 Q Now, Dr. Craker, then, I take it that
21 you're going to rely on Dr. Doblin to find
22 customers if and when you get your registration as
0390
1 a DEA manufacturer of marijuana.
2 A That would be the initial work in this
3 area, yes.
4 MR. BAYLY: That's all on recross.
5 JUDGE BITTNER: Okay; re-redirect?
6 MS. CARPENTER: Just bear with me, Your
7 Honor.
8 FURTHER REDIRECT EXAMINATION
9 BY MS. CARPENTER:
10 Q Dr. Craker, you indicated that you had
11 talked with Dr. Doblin a lot about the information
12 that you got in the paragraph one of Government's
13 Exhibit No. 3, and that paragraph was what's the
14 purpose of the bulk manufacturer.
15 A Yes.
16 Q And why did you talk to Dr. Doblin about
17 the purpose of the bulk manufacturer?
18 A Well, because Dr. Doblin was my primary
19 contact at the time, and I guess I needed someone
20 to discuss with, and he was handy.
21 Q And were you guys doing this together?
22 When I say this, I mean this whole project of
0391
1 developing marijuana and--
2 A Yes, that was the initial thought there,
3 yes, that we were working on this collectively,
4 yes.
5 Q As a joint effort?
6 A A joint effort, yes, I would say it could
7 be considered a joint effort.
8 Q And then, question number two, I think you
9 said you provided that information.
10 Would you look at question number three?
11 Is that information relating primarily to the
12 growing or supplying?
13 A Yes, it has to do with the growing of the
14 material.
15 Q Okay; and the same thing about question
16 number four.
17 A That has to do with the growing the
18 material also, yes.
19 Q Okay; and question number five?
20 A Has to do with growing the material except
21 for the seed supply.
22 Q Okay; so, would it be fair to say that
0392
1 with regard to how the stuff would be grown, you
2 would provide the information?
3 A Yes, definitely.
4 Q And with regard to the uses in research,
5 Dr. Doblin essentially provided the information?
6 A Yes.
7 MS. CARPENTER: One moment, Your Honor.
8 I think that's all, Your Honor.
9 MR. BAYLY: Finally, that's all.
10 JUDGE BITTNER: You may step down, Doctor.
11 THE WITNESS: Thank you.
12 [Witness excused.]
13 JUDGE BITTNER: Dr. Craker, you have
14 decided you don't want to stay and watch the rest
15 of this?
16 DR. CRAKER: I would love to, but my wife
17 said I have to come home a day before I went to
18 Atlanta, so--
19 JUDGE BITTNER: I see.
20 DR. CRAKER: It will give me a chance to
21 go home and see what she looks like briefly.
22 [Laughter.]
0393
1 JUDGE BITTNER: Okay; have a good trip.
2 Ms. Carpenter.
3 MS. CARPENTER: Yes, Your Honor, we would
4 call Former Senator John Vasconcellos.
5 Whereupon,
6 JOHN VASCONCELLOS
7 was called as a witness herein and, after being
8 duly sworn, was examined and testified as follows:
9 DIRECT EXAMINATION
10 BY MS. CARPENTER:
11 Q Would you state your name for the record,
12 please?
13 A Certainly, John Vasconcellos.
14 Q Would you spell it for the record, please?
15 A Certainly; V-as in Victor-A-S-as in Sam-C-O-N as
16 in nickel-C-E-L-L-O-S as in Sam.
17 JUDGE BITTNER: O-S or A-S? I'm sorry.
18 THE WITNESS: O-S.
19 JUDGE BITTNER: All right.
20 BY MS. CARPENTER:
21 Q And what's your address, Mr. Vasconcellos?
22 A My home address is 1915 Bellomy Street B-E-L-L-O-M
0394
1 as in Michael-Y Street in Santa Clara,
2 California 95050.
3 Q Mr. Vasconcellos, what do you do?
4 A I'm retired as of November 30, 2004.
5 Q And what did you retire from?
6 A I retired from 38 years of service in the
7 California Legislature, representing the heart of
8 Silicon Valley.
9 Q Okay; were you a Senator? An Assemblyman?
10 A I was in the Assembly from 1967, January,
11 to 1996 and in the Senate from 1996 until 2004; 30
12 and then eight and then left because of term
13 limits, not because of any other decision.
14 [Laughter.]
15 THE WITNESS: They took it out of my
16 hands, my voters' as well.
17 BY MS. CARPENTER:
18 Q Rather than the alternative.
19 A Because my voters--I'm sorry.
20 [Laughter.]
21 Q At some point during your service to
22 California, did you get involved in setting up
0395
1 research relating to medical marijuana?
2 A Yes.
3 Q Can you tell us how that came about?
4 A Most immediately in 1996, the people of
5 California passed Proposition 215, which called for
6 the decriminalization of marijuana for medical uses
7 upon certain prescribed conditions. And I had
8 earlier carried legislation that would have
9 decriminalized medical marijuana for only four
10 conditions: glaucoma, sclerosis, I think cancer
11 and AIDS, and that was passed and vetoed by the
12 Governor.
13 And then, people took it to the ballot,
14 and it was put on the ballot, and I did not partake
15 in the drafting of it, but I did support it. It
16 was enacted by a heavy vote of the people in 1996.
17 And I then felt we ought to honor the vote of the
18 people, the will of the people, and proceed to put
19 together what it would take to have the people's
20 will carried forward in terms of its not being
21 illegal in California under the California people's
22 enacted law to partake of marijuana for medical
0396
1 purposes under those same conditions.
2 At the same time, a curious thing
3 developed: we had a governor's race that year, and
4 the one candidate had fiercely opposed--the June
5 ballot was the Initiative 215. One guy had
6 severely, staunchly, avidly opposed it. As soon as
7 it passed, he declared we don't enough about it; we
8 should do some research and find out what the truth
9 is about the use of marijuana for medical purposes.
10 I thought great idea and great
11 opportunity. So I introduced legislation to create
12 the University of California Medical Cannabis
13 Research Center, after discussing with the
14 university, with my colleagues, and with the
15 attorney general, who is now in the Congress from
16 California. I think he would call himself a
17 conservative Republican.
18 And he and I together wrote the
19 legislation. And every word, every word was
20 negotiated by his chief of staff and mine to make
21 the legislation absolutely above reproach about
22 objective research.
0397
1 Q And let me just stop you there for a
2 minute and ask you what did the legislation do?
3 A It created, within the University of
4 California, the university concurring, a research
5 center, and it provided funding. It began at $1
6 million a year for three years. We went to $3
7 million a year for three years, a total of $9
8 million, to conduct research by all of the rigorous
9 protocols could be properly called upon to find out
10 whether in fact marijuana has medical value for
11 illnesses or whether it doesn't. And if it does,
12 what up sides, what down sides, what risks, what
13 benefits and what methodologies might be entailed.
14 JUDGE BITTNER: And what is the name of
15 this research center?
16 THE WITNESS: It is the University of
17 California Center for Medical Cannabis Research.
18 The university, the president of the university,
19 Richard Atkinson, by executive order created it;
20 the Regents approved it, I believe, and it was
21 chosen to have the University of California at San
22 Diego be the major host and the University of
0398
1 California at San Francisco be a secondary host but
2 the entire system be involved in the protocols, the
3 proposals, and the operation of the center.
4 BY MS. CARPENTER:
5 Q And is that what's also come to be known
6 as CMCR?
7 A That is correct.
8 Q Okay; so did that research occur?
9 A The research was begun, and it took awhile
10 to get it going, because they were so careful to
11 work with the Federal, you know, all the agencies,
12 so the DEA, and NIDA--I don't know, because I was
13 not involved in that at the ground level, to get
14 everything done particularly strictly by scientific
15 protocols and to, before they went out public for
16 the grant proposals to be sure everything was
17 okayed by the Federal Government for this process.
18 And to my understanding, and I've been on
19 an advisory group, and I've followed it closely,
20 and one of my friends, in fact, has been involved
21 in helping to direct it, carefully--it took awhile.
22 Money was made available, and they put out the
0399
1 research proposals, and there have been 15
2 proposals funded over the course of these--I guess
3 it's about five years now since the center was
4 created. And each of them, I mean, there were more
5 proposals that they could fund.
6 Each of them was--the statute required
7 that they create a scientific advisory committee to
8 be sure it was done appropriately. Upon the
9 proposals they had selected, they were each
10 submitted to three members of the Committee,
11 scientists, who would first vet it and then say
12 these ones should go forward to the full Committee,
13 these ones shouldn't. And those that did went to
14 the full Committee, which vetted all of them, I
15 think through Internet conversations, and 15 have
16 been selected and funded, and the others were not.
17 Q Okay; do you know if NIDA provided the
18 marijuana for that research?
19 A I believe so.
20 Q And the researchers were all licensed by
21 DEA, I think you said?
22 A I believe every proposal was approved by
0400
1 whoever--HHS, DEA; I mean, I don't know the Federal
2 Government. I was fully occupied with California
3 in my tenure, but they were all approved here
4 individually and en masse eventually to obtain the
5 marijuana and then to proceed with the research.
6 Q Okay; and is that research over?
7 A No, it's still going on. In fact, not one
8 of the studies have been fully completed and
9 reported on yet, although I am advised that there
10 are two of them that have been completed, and the
11 results are now being written up and hopefully will
12 be published in a medical journal as appropriate.
13 And--
14 Q Sorry; is there further funding for
15 additional research to be carried out by that
16 group?
17 A There is not. And there is not--well, two
18 things on that question, if I may. The first
19 legislation created a four-year program, at which
20 point the center dissolved, sunsetted is the term
21 they used. After three years, it was clear that
22 this research takes longer than, you know, a year
0401
1 or two years or three years to do it properly and
2 find a result that is, whichever way, legitimate
3 and convincing, hopefully to all people who are
4 attending to it.
5 So the sunset was removed I guess two
6 years ago. The funding, we got $3 million a year
7 for three years, and then, California fell upon
8 what you must have known about here, the dot-com
9 collapse, and our state budget was $40 billion
10 short, and there was no way to get more money for
11 medical marijuana research, much less keep the
12 universities open without doubling the fees and
13 tuition so there was no more money.
14 And sad to say, in the three years since,
15 there has been no successful effort accomplished by
16 the government sector to rewrite, to recorrect
17 California's fiscal imbalance. So there has been
18 no more money, and I can't predict the future, but
19 there is nothing on the horizon that would indicate
20 that California is going to be back in the black
21 very soon.
22 Q So is it likely that that research is
0402
1 pretty much done when it's done?
2 A It's likely that that research is done
3 when it's done. Whether that center will be able
4 to obtain other funding sources for additional
5 research remains to be seen. Certainly, they have
6 made themselves credible, I think, across all
7 boundaries, and they're looking for that but so far
8 have not found any of that that I know of and, you
9 know--
10 Q Was the center designed, since you drafted
11 the legislation, was it designed to develop
12 marijuana into a medical drug that would be
13 approved by the FDA?
14 A No, no, it was on my mind, and it would
15 not have ever gotten the attorney general's
16 approval and the bill passed. I mean, to pass a
17 bill in our legislature, unlike all but one other
18 state, requires a two-thirds vote in both houses
19 and the governor to sign.
20 That meant I had to get in my house like
21 four Republicans, and I finally got four of the
22 most conservative, by their own self definition, no
0403
1 one of which wanted to be the 27th vote. So I said
2 how about all four of you standing at once and
3 saying aye? And it was the first and only chorus
4 in the history of our legislature; the bill was
5 passed and stood, and it was simply worded to find
6 out whether in fact the claims about marijuana
7 being medically of value had substance
8 scientifically or did not.
9 And if, insofar is there is some substance
10 or value, are there benefits, and are there risks
11 like in smoking or whatever, and if so, how much of
12 which, and are there other ways with respect to
13 marijuana--FDA was not talked about in terms of
14 approval; it was not calculated to look for
15 approval. It was calculated to demystify the
16 roaring contentions of contrary viewpoints and to
17 find out by science carefully designed and
18 commissioned and arbitrated by the protocols to
19 find out whether, in fact, it's of any use.
20 Q And when you're talking about medical
21 marijuana, are you talking about the medical
22 marijuana plant, or are you talking about isolated
0404
1 pieces of it?
2 A The best answer is the legislation itself,
3 since it was so carefully drafted. And I'm sure
4 it's available to the Court. I would--certainly,
5 we can have it, you know, faxed back to you, and
6 you can read that.
7 Q It's in the California Statutes.
8 A Your question again?
9 Q Was the CMCR designed to test smoked
10 marijuana or vaporized marijuana?
11 A At that point, vaporized marijuana had
12 barely been mentioned, in my recollection. And
13 smoked was the usual delivery system that seemed to
14 be operating, if sub rosa then.
15 And you may know also that the legislation
16 also directed the legislature and the governor to
17 put together a system for distribution so that
18 those people who could now use it without criminal
19 sanction could get it and that those who helped
20 provide that would also--but it was all about that
21 process. But at that point, as I recall, smoked
22 was the more likely. Other things were only being
0405
1 talked about or proposed, but they were not on the
2 table particularly.
3 Q And I think you said that the money had
4 run out. Do you know if California, the state,
5 plans to continue this research some other way or--
6 A Well, you know, the votes are probably
7 there to do it except that there is no money there
8 to do that, and I left only in November, at which
9 point the state was terribly short of funds for
10 that last fiscal year and had a budget deadlock
11 that went almost until September. And I'm not
12 there now, but this year, I read about the budget
13 fight; it went on again, and they passed it again
14 together without any money, without even paying the
15 bills that we should.
16 So California is still in the red by
17 several billion dollars.
18 Q Do you think it would be appropriate for
19 private research organizations to take the results
20 of this and build on it if it looks promising?
21 A Well, if it looks promising, if it looks
22 promising, it seems to me that people have a right
0406
1 to know more about what might help them in their
2 suffering and pain or illness, whatever it might
3 be; whatever it might be and that the more
4 research, the better, provided it's rigorous and
5 according to protocol and objective and careful and
6 approved by everybody who has to approve it.
7 I don't think 15 studies are likely to be
8 sufficient to resolve this matter, and I would
9 guess if they come in with some show of efficacy,
10 then, it would seem in the public interest smart
11 and to me appropriate to find out more about it.
12 MS. CARPENTER: I think that's all we
13 have, Your Honor.
14 JUDGE BITTNER: Okay; cross?
15 CROSS-EXAMINATION
16 BY MS. PAREDES:
17 Q Mr. Vasconcellos--
18 A Vasconcellos, please.
19 Q Vasconcellos; sorry. Are you familiar
20 with an author by the name of Bernard Goldberg?
21 A Bernard Goldberg, no.
22 Q Are you familiar with a book called 100
0407
1 People Who are Screwing Up America?
2 A I've had emails from friends about the
3 book.
4 Q So, I'm sorry, I didn't hear your
5 response.
6 A I have had friends email me about the book
7 and congratulate me on making it.
8 MS. CARPENTER: Your Honor--never mind.
9 BY MS. PAREDES:
10 Q So you haven't actually read it?
11 A I haven't read it, nor have I seen what it
12 has to say.
13 Q Well, you testified on direct that you
14 supported the CMCR bill.
15 A I authored the bill.
16 Q You authored the bill.
17 A Yes; I thought it up; I created it; I
18 authored it; and I support it, of course.
19 Q To determine whether marijuana has value
20 as a medicine.
21 A Yes.
22 Q Is that accurate?
0408
1 A Yes.
2 Q Now, when these studies, when the results
3 from the CMCR are finally published, I assume--are
4 there any published now?
5 A No.
6 Q Okay; when they are published, will you
7 take their recommendations and conclusions as
8 valid?
9 A I expect so. You know, I never know what
10 I'll do until I see something, so I don't predict
11 my own behavior. I always try to act with
12 integrity in the moment.
13 Q So hasn't there been a time in the past
14 when scientific studies disproved a bill that you
15 sponsored or a movement in California that you
16 sponsored, and your response was all the research
17 in the world won't change my mind about it?
18 A Do you want to be specific what you're
19 talking about?
20 Q Yes, do you recall sponsoring legislation
21 called or creating a task force called the
22 California Task Force to Promote Self Esteem and
0409
1 Personal and Social Responsibility?
2 A Yes, I do; my proudest work in 38 years; I
3 do.
4 Q I'm sorry?
5 A It's my proudest work in 38 years.
6 Q And that task force issued a report
7 declaring self esteem a vaccine that would attack
8 academic failure, drug use, and juvenile crime.
9 A If I may, that's inaccurate.
10 Q Excuse me?
11 A That's inaccurate.
12 Q What report did it issue?
13 A It issued a report in January--the bill
14 was passed and finally signed by George Deukmejian,
15 a very conservative Republican Governor, in 1986.
16 It created a task force whose challenge was to find
17 out whether, in fact, self esteem is important in
18 issues of violence, educational failure, drug
19 abuse, child abuse, welfare dependency, and a sixth
20 field.
21 The task force was created; the Governor
22 and I negotiated this. He named the chair. He
0410
1 named nine of the 25 members. The majority were
2 Republican of the 25, 13 to 12, and they included
3 everybody from cops, the attorney general to gay
4 therapists and housewives, and I served ex officio
5 on the task force.
6 It worked for three years. We had 400
7 applicants for the task force, the most history for
8 anything in California. And they had, like, 18
9 hearings, and they had 15 meetings, and the average
10 attendance was 21. They produced a report in
11 January 1990 called Toward a State of Esteem. And
12 in that report, they said the research is at this
13 point still scanty, but it looks as though, it
14 didn't declare; it said it looks as though self
15 esteem is probably helpful.
16 And then, it quotes Dr. Jonas Salk of the
17 Salk vaccine fame as saying it looks like it
18 amounts to a social vaccine. And I thought Jonas
19 Salk was a pretty good authority for me to quote in
20 the report. I didn't write it; the task force
21 wrote it. It didn't declare. It just said looks
22 like--it was indicative; that's the task force and
0411
1 its report.
2 Q And as a result of the task force and the
3 report, were self esteem programs placed in
4 elementary schools in thousands of districts in the
5 State of California?
6 A As a result of the report, self esteem
7 became widely known throughout the world, including
8 some satire by Doonesbury you might have seen,
9 maybe not. And it became popular in many places,
10 in prisons, for prison reform, rehabilitation, in
11 some schools, not because of the report; the report
12 dictated nothing. The report just said it looks
13 like it's valuable. From my granddaughter's
14 experience, it looks like it's really valuable
15 anyway.
16 A lot of schools, because of their own
17 teachers and their own administrators and their own
18 trustees adopted programs to attempt to prepare
19 children with healthier self esteem to face the
20 world in mature ways. I think the most model was
21 the Moreland District of West San Jose, and Bob
22 Riesner was Superintendent of Schools there, we're
0412
1 still in touch as friends.
2 His district, after self esteem for the
3 parents, the kids, the teachers, the trustees left
4 with no truancy. They all went on to school; there
5 were no drop-outs, no truancy, and no graffiti. It
6 was a remarkable result in that school. That's the
7 most prominent one. There weren't thousands, but
8 there were a lot.
9 Q Well, since the institution of those
10 programs in schools, haven't research studies shown
11 that in academic terms, self esteem curricula are
12 worse than useless?
13 A No, they haven't. You're quoting the
14 Baumeister study, obviously, from Roy Baumeister
15 from Pennsylvania.
16 JUDGE BITTNER: I'm sorry; I missed that.
17 THE WITNESS: A man named Roy Baumeister,
18 B-A-U-M-E-I-S-T-E-R.
19 JUDGE BITTNER: Okay.
20 THE WITNESS: He's from Pennsylvania, I
21 believe--who has made a career out of ragging on
22 self esteem. Says a little about him, I think.
0413
1 And if you read the report and his studies, he
2 misdefines it, to start with. He misdefines this
3 thing. You get obviously a result that isn't worth
4 two cents.
5 The task force that I authored, after
6 weeks of argument with two fundamentalist Christian
7 ministers and the gay therapist and people of all
8 race, color, orientation--I mean, it was California
9 as you all think about it, and they negotiated,
10 they argued, and they put a definition together
11 about self esteem being that which holds me
12 accountable for myself and responsible to others.
13 And that--
14 BY MS. PAREDES:
15 Q Well, sir, but that's not my question. My
16 question is have there been research studies that
17 have shown that self esteem curricula is [sic]
18 useless.
19 A Not that I know of.
20 Q There are tens of thousands of research
21 studies have--you haven't seen tens of thousands of
22 research studies that--
0414
1 A No, I haven't seen one that I think is
2 credible.
3 Q Were you ever interviewed concerning these
4 self curricula?
5 JUDGE BITTNER: I'm sorry; what was the
6 question?
7 BY MS. PAREDES:
8 Q Were you ever interviewed concerning the
9 introduction of self esteem curricula in the
10 schools?
11 A You know, I don't recall, but I'm sure I
12 must have been, because I was well noted for being
13 a major champion in the field. I undoubtedly was
14 interviewed.
15 Q Do you recall ever being confronted with
16 the these research studies that show that self
17 esteem curricula is not useful?
18 A Not a one that had any valid definition as
19 a basis for the research.
20 Q And do you recall saying all the research
21 in the world won't change my mind about it?
22 A That's true, because my granddaughters are
0415
1 10 and 15; they have self esteem, and there
2 couldn't be healthier kids in the whole world than
3 those two. They're more powerful than any
4 research.
5 Q So assuming that there were research
6 studies that showed self esteem curricula were not
7 useful, those studies would not change your mind?
8 A Probably not, but I haven't seen any. I
9 bet you haven't either, but that's gratuitous. I'm
10 sorry.
11 Q Now, you testified that there were 15
12 proposals funded over the past five years by CMCR.
13 A Yes.
14 Q How many proposals were put to CMCR for
15 approval?
16 A There were--I don't know the answer to
17 that question.
18 Q Were there more than 15?
19 A Yes.
20 Q Can you estimate how many were sent to--
21 A No, I don't want to guess under oath. Not
22 appropriate.
0416
1 Q So would it be your testimony that some
2 proposals were refused?
3 A Yes; I talked last night with one of the
4 principals there, and he said yes, some were
5 refused, because the money only would support 15.
6 Q Is that the only reason some were refused?
7 A That's the only reason some were refused.
8 And some were refused because they didn't measure
9 up scientifically. This was a very serious
10 operation.
11 Q You mean because they lacked scientific
12 merit?
13 A Pardon?
14 Q Because they lacked scientific merit?
15 A Some were refused because they didn't have
16 sufficient scientific merit, yes, and those that
17 were approved were then all approved by the FDA,
18 some after further change, but all of them--
19 JUDGE BITTNER: Do you know--I don't
20 remember, Mr. Vasconcellos, if you testified--you
21 were not involved in the selection process for this
22 project; correct?
0417
1 THE WITNESS: Not at all. I went to the
2 first meeting of the group to kick it off, and I
3 went back to visit. But I was not involved, no.
4 JUDGE BITTNER: Do you know whether all
5 the projects that were considered for funding
6 already had appropriate Federal approvals to use
7 marijuana? In other words, do you know which was
8 the chicken and which was the egg?
9 THE WITNESS: I think the chicken was the
10 submission to the center, and after vetting it,
11 three persons and then the whole scientific group,
12 they selected the ones that would be chosen with
13 the funds that were available. Those were all then
14 forwarded to the Federal Government, FDA or HHS;
15 I'm not quite sure which agency back here does
16 what, and every one of them was then reviewed by a
17 totally different set of scientists unknown to the
18 center staff, and every one of them was, though
19 some with comments and edits, all 15 of those then
20 were approved by the Feds and are in operation now.
21 JUDGE BITTNER: I guess what I was trying
22 to get at is depending on which came first, if
0418
1 there were sort of eccentric proposals, let's call
2 them, then, they wouldn't have been vetted--they
3 wouldn't have received the requisite Federal
4 approvals before going to the center; in other
5 words, the screening out would have been by the
6 center first.
7 THE WITNESS: I think it was the center
8 first, and I think they screened out the eccentric
9 ones first.
10 JUDGE BITTNER: Okay; thanks.
11 THE WITNESS: The ones that they approved
12 were all approved, each approved back here.
13 BY MS. PAREDES:
14 Q With regarding to funding, looking for
15 more funding for research.
16 A Yes.
17 Q Do you know where CMCR has been looking
18 for funding?
19 A Well, they've been hoping the Federal
20 Government might come through with some, but I
21 don't know a lot about that. I just heard that.
22 Q So are you personally involved in looking
0419
1 for more funding?
2 A No, I'm retired.
3 Q Have you heard, then, of anywhere else
4 that CMCR might be trying to look for funding aside
5 from the Federal Government?
6 A I don't think I have.
7 Q Of the 15 studies that were approved by
8 CMCR, were any discontinued before they were
9 completed?
10 A Yes.
11 Q How many?
12 A I don't know.
13 Q Do you know the reasons why they were
14 discontinued?
15 A The main reason why was because some of
16 the studies couldn't get enough subjects to have a
17 legitimate sufficient number for a study, so the
18 center said we're not going to do it. In other
19 words, you have to 24 or--you have to have some
20 number of subjects to have a research project.
21 Some couldn't find enough. One of them was about,
22 I think, some form of cancer, and they couldn't get
0420
1 more than half a dozen, so it was canceled.
2 Q Are you aware of any other reasons they
3 would have been discontinued?
4 A I'm not aware of any other reasons.
5 MS. PAREDES: Nothing further.
6 JUDGE BITTNER: Redirect.
7 MS. CARPENTER: Just one second.
8 REDIRECT EXAMINATION
9 BY MS. CARPENTER:
10 Q Let me just ask you real quick, Senator:
11 have you heard of anybody else who's made it into
12 this book, 100 People Screwing Up America?
13 A You know, the first guy who came through
14 mentioned a couple others, but I forgot who they
15 were.
16 Q Do you want me to refresh your
17 recollection? Jimmy Carter?
18 A Might be.
19 Q Barbara Walters?
20 A I think it--yes; as I said, I'm proud to
21 have made that list.
22 MS. CARPENTER: Norman Mailer--I think
0421
1 that's all I have.
2 JUDGE BITTNER: Okay; any recross?
3 MS. PAREDES: No.
4 JUDGE BITTNER: Okay; thank you very much,
5 Mr. Vasconcellos.
6 THE WITNESS: Thank you.
7 JUDGE BITTNER: Have a good trip back.
8 THE WITNESS: I will.
9 [Witness excused.]
10 JUDGE BITTNER: Would you like a short
11 break before your next witness.
12 MS. CARPENTER: That would be good.
13 JUDGE BITTNER: Okay; 10 minutes?
14 MS. CARPENTER: Thank you, Your Honor.
15 [Recess.]
16 JUDGE BITTNER: Okay; Ms. Carpenter.
17 MS. CARPENTER: Yes, Your Honor, Mr. Allen
18 Hopper is going to be conducting the next
19 examination.
20 JUDGE BITTNER: Okay.
21 MR. HOPPER: Thank you, Your Honor.
22 Respondent calls Dr. Dale Gieringer.
0422
1 Whereupon,
2 DALE GIERINGER
3 was called as a witness herein and, after being
4 duly sworn, was examined and testified as follows:
5 DIRECT EXAMINATION
6 BY MR. HOPPER:
7 Q Can you please state and spell your first
8 and last name?
9 A Dale Gieringer, that's G-I-E-R-I-N-G-E-R.
10 JUDGE BITTNER: G-A-E--
11 THE WITNESS: G-I-E--
12 JUDGE BITTNER: I've already messed up;
13 okay. I-N-G--
14 THE WITNESS: G-I-E-R-I-N-G-E-R.
15 JUDGE BITTNER: Okay; and your first name?
16 THE WITNESS: Dale, D-A-L-E.
17 BY MR. HOPPER:
18 Q And I'm going to apologize in advance,
19 because I've been in my head calling you Dr.
20 Gieringer. I'm going to try to call you Dr.
21 Gieringer, because that's how you just pronounced
22 it, but I'm sure I'm going to mess that up, so
0423
1 please forgive me.
2 And where do you reside?
3 A 3514 Dwight Way--D-W-I-G-H-T--in Oakland,
4 California.
5 Q And Dr. Gieringer, can you please tell us
6 about your education? Do you hold an undergraduate
7 degree?
8 A Yes, A.B. from Harvard in mathematics.
9 Q And when you say A.B., I'm sorry; that's
10 a--
11 A That's a B.A. to other people who don't
12 speak Latin.
13 Q That's a B.A. in Harvardspeak.
14 A Yes, right.
15 Q And, I'm sorry; in what field of study?
16 A Math.
17 Q And do you also hold an advanced degree?
18 A Yes, a Ph.D. from Stanford Department of
19 Engineering Economic Systems.
20 Q And can you please tell us a little bit
21 about that program, engineering economic systems?
22 That's something that I'm familiar with.
0424
1 A That was a cross-disciplinary program that
2 involved economics, policy analysis, and decision
3 analysis.
4 Q And what specifically did your studies
5 focus upon in that program?
6 A I focused on FDA drug regulation. I wrote
7 my Ph.D. dissertation specifically on that subject.
8 Q Excuse me; and the topic of your
9 dissertation was?
10 A Consumer choice and FDA drug regulation.
11 Q And what year did you obtain that degree?
12 A 1984.
13 Q And how many years did you work on
14 researching and writing that dissertation?
15 A Four or five.
16 Q And in the course of that work, did you
17 conduct extensive work into the FDA regulatory
18 process for developing and approving new drugs for
19 use by patients in the United States?
20 A You bet.
21 Q And are you affiliated with any
22 organizations that are concerned with medical
0425
1 marijuana?
2 A Yes.
3 Q And can you tell us what those
4 organizations are? And I know that one of them is
5 going to be CMCR, and I'd like you to save that one
6 for last, please. Tell us about the others first.
7 A Well, to begin with, I'm the California
8 coordinator for NORML, the National Organization
9 for the Reform of Marijuana Laws, which is devoted
10 to general marijuana reform, as you know, and as a
11 subset of that or corollary of that, of course, we
12 also support medical marijuana and have from the
13 very beginning.
14 Q And I'm sorry; you said you're the
15 California--
16 A Coordinator for NORML.
17 Q Coordinator.
18 A Yes.
19 Q And is that a full-time job?
20 A Yes.
21 JUDGE BITTNER: And what does it entail?
22 THE WITNESS: It entails legal aid, press
0426
1 releases, research, lobbying, the gamut, answering
2 phone calls.
3 JUDGE BITTNER: And are you like the
4 executive director for NORML in California?
5 THE WITNESS: The coordinator, yes, I head
6 the home office, out of which I work, yes.
7 JUDGE BITTNER: So you're the
8 administrative head of--
9 THE WITNESS: Yes, representative of NORML
10 in California.
11 JUDGE BITTNER: Okay.
12 BY MR. HOPPER:
13 Q Okay; and are there other organizations
14 that you're affiliated with that are also concerned
15 with medical marijuana?
16 A Yes, there's the IACM, International
17 Association for Cannabis Medicine.
18 Q And can you tell us just briefly what that
19 organization is?
20 A Yes, that's a collection of scholars and
21 researchers interested specifically in medicinal
22 cannabis, which they do publications and
0427
1 conferences that I've participated in.
2 Q And I'm sorry; your affiliation with them
3 is as a--
4 A I'm an affiliate. I'm a member.
5 Q It's a membership organization?
6 A Yes, for researchers.
7 Q And you said something about presenting at
8 conferences.
9 A Yes, they have a conference coming up in a
10 couple of weeks that I'll be presenting at. And
11 they also have a journal, the Journal of Cannabis
12 Therapeutics, and I was on the editorial board of
13 that.
14 Q And the upcoming conference, what's your
15 presentation going to--
16 A On medicinal use of marijuana in
17 California.
18 Q Other organizations?
19 A Let's see: Drug Policy Forum of
20 California, sort of an email list, basically; I
21 mean, I'm a member of most of the drug reform
22 organizations one way or another.
0428
1 Q I'm sorry; you mentioned the Drug Policy
2 Reform Coalition?
3 A Yes--Drug Policy Forum of California.
4 That's just an email list, basically.
5 Q An email list; okay; what about an
6 organization called Californians for Compassionate
7 Use.
8 A Yes, I was involved with Californians for
9 Compassionate Use.
10 Q And can you tell us about that
11 organization?
12 A Yes, well, they were involved in
13 establishing the California Compassionate Use Act,
14 Proposition 215 back in 1996. I haven't really
15 been affiliated with them since Proposition 215
16 passed.
17 Q And what was the nature of your
18 affiliation with that organization or your
19 participation?
20 A I was the treasurer.
21 Q And then, the one I asked you to save for
22 last; you're also affiliated with the Center for--
0429
1 A Medicinal Cannabis Research; yes, I'm on
2 the National Advisory Council.
3 Q And that's the organization--I'm sorry;
4 you were present for Senator John Vasconcellos'
5 testimony just a moment ago.
6 A Yes.
7 Q That's the organization that he was
8 testifying--
9 A Same one.
10 Q And that is also known by the acronym
11 CMCR.
12 A Right.
13 Q And again, I apologize. I'm sure I'm
14 going to mess up that acronym at some point during
15 the day.
16 Have you reviewed the proposed testimony
17 from you that was submitted to the administrative
18 law judge on behalf of Respondent in this matter?
19 A Yes.
20 Q Did you and I sit down and look at that?
21 A Yes.
22 Q And did you see that it included an
0430
1 assertion that you are on the advisory board of
2 MAPS?
3 A Yes, that's in error. I don't know where
4 that came from. I've never said such a thing, and
5 it's not on my CV. So that's an error.
6 Q That's just incorrect.
7 A Yes.
8 Q A mistake that was made by your lawyers or
9 by lawyers.
10 A I guess so.
11 MS. CARPENTER: Just leave it.
12 [Laughter.]
13 BY MR. HOPPER:
14 Q I like that better.
15 Okay; let's talk about the Center for
16 Medicinal Cannabis Research, CMCR. Tell us about
17 your affiliation with them. You said you were on a
18 council?
19 A The National Advisory Council, it's
20 called.
21 Q And how did you come to be on the National
22 Advisory Council?
0431
1 A The legislation that established the CMCR
2 calls for an advisory council, and I was appointed
3 to it as a public interest member, representative.
4 Q Okay; have you reviewed recently the
5 statute that you just mentioned?
6 A Yes.
7 Q The enabling statute?
8 A Yes.
9 Q And is that California Health and Safety
10 Code Section 11-362.9?
11 A So it is.
12 Q So can you tell us, then, what is CMCR? I
13 know we heard some testimony about it from Senator
14 Vasconcellos. But can you tell us just briefly--
15 A Well, it's a research center headquartered
16 at the University of California-San Diego that
17 coordinates and conducts studies on medical use of
18 cannabis. It's funded them and shepherds them
19 through the regulatory process and the whole works.
20 Q Okay; and can you tell us just a little
21 bit about your duties as a member of the National
22 Advisory Council?
0432
1 A Well, The national Advisory Council is
2 supposed to oversee the center and make sure it
3 adheres to its basic legislative mandate base.
4 Q And the Center is, I think, did you say it
5 was affiliated with the University of California?
6 A Yes, and located specifically--their
7 physical headquarters is at San Diego.
8 Q Okay; but the research that they
9 undertake, does that all happen in--
10 A That's around the state; various
11 University of California campuses are conducting
12 the research.
13 Q So the research is conducted, just to make
14 sure I understand it, at campuses throughout the
15 State of California. It's coordinated from an
16 office at the University of California-San Diego.
17 Were you--and I think you told us you were involved
18 in the drafting. I guess you referred to this
19 legislation, the CMCR enabling legislation.
20 A Yes.
21 Q Were you involved in some way in the
22 drafting of that legislation?
0433
1 A Yes, I was.
2 Q And can you tell us what your involvement
3 was?
4 A Well, there was sort of a committee of
5 people who had been involved in the medical
6 cannabis issue who worked with legislative staff,
7 Senator Vasconcellos' staff in particular, in
8 developing the legislation.
9 Q Dr. Gieringer, you told us earlier that
10 the work you did writing and researching your
11 doctoral thesis at Stanford required you to conduct
12 extensive research regarding the regulatory
13 process, the FDA regulatory process; is that
14 correct?
15 A Yes.
16 Q And does the FDA approval process involve
17 or require specific types of research that are
18 distinct from the sorts of research that has been
19 undertaken by CMCR?
20 A Yes.
21 Q And can you give us a brief overview--again, we've
22 had extensive testimony from earlier
0434
1 witnesses about the regulatory process, and I don't
2 need you to get into that kind of detail, but if
3 you can just give us enough of an overview so we
4 can understand the distinction between the research
5 that is undertaken at CMCR and the research that
6 would be required to take a drug through the FDA
7 approval process.
8 A Okay; well, CMCR is just doing pure
9 research studies with no aim of actually developing
10 a drug or bringing it to market. If they wanted to
11 bring a drug like marijuana to market, they would
12 have to go through an involved process called
13 filing--where they have to file an apologize for
14 new drug approval, or an NDA, as it's called, with
15 the FDA.
16 And in order to get through the new drug
17 approval process and win approval of their drug,
18 they would have to file an exhaustive amount of
19 information about studies showing the drug was safe
20 and effective. And this would include animal
21 toxicity studies, it would include human toxicity
22 studies, so-called phase one studies; phase two
0435
1 studies, which generally involve, you know, a few
2 dozen subjects that are aimed at demonstrating
3 efficacy in certain populations of patients with
4 certain indications; and then, phase three studies,
5 which are large-scale clinical studies, usually
6 involving hundreds of patients, which are sort of
7 the acid test for showing that the drug is really
8 effective and safe in clinical use, and the FDA
9 usually likes to see one or two of those phase
10 three studies plus anything else before they will
11 grant a new drug approval.
12 Q So let me just ask you hypothetically, if
13 I wanted, if I were a researcher, and I wanted to
14 take marijuana through the FDA approval process to
15 make it into a prescription medicine, would I be
16 able to rely upon the research, the specific
17 research that's been done at CMCR? Would I be able
18 to use that research as part of my own application
19 for an IND or an NDA?
20 A Well, you might be able to cite the
21 literature in your new drug application, but there
22 would be other, more important things that you
0436
1 would have to do, like, to begin with, you would
2 have to get a drug master file. You would have to
3 get the product.
4 You would have to have a drug to present
5 to the FDA, which involves, you know, having a
6 production process, an manufacturing process, and
7 explaining all that to the FDA in the first place
8 so you have something to present to them for
9 approval. So that would be the first step that you
10 would have to do, and then, you would have to
11 conduct studies with that drug.
12 You might possibly be able to cite to the
13 California studies as part of the phase two
14 evidence, but you would also need some phase three
15 work done, you would definitely need some work done
16 with your specific product, because the product
17 that they're using at University of California
18 would be the NIDA marijuana, and if you had your
19 own marijuana, that would be different. So there
20 would be issues there that the FDA would have to
21 deal with.
22 Q Well, let me just ask you about that for a
0437
1 minute. If I were going to try to conduct these
2 studies that we're talking about to move a drug,
3 marijuana, through the FDA approval process, I
4 mean, and let's say that I were able to convince
5 NIDA to supply the marijuana to me to do the
6 research studies: then, would I be able to--you
7 were saying I needed my own product.
8 A Yes.
9 Q Why couldn't I just use NIDA's marijuana
10 as my product?
11 A Well, that makes no sense. First of all,
12 as I say, you need sort of a drug master file to
13 work off of. You have to have--you're presenting a
14 product; I mean, it's like can I take out an NDA
15 for Bayer aspirin? I mean, that makes no sense.
16 Bayer already has the aspirin. I can't sell
17 Bayer's aspirin. I have to sell my own aspirin, so
18 I would have to start a whole new manufacturing
19 process myself for aspirin, and the same thing
20 would go for marijuana.
21 Q So I would need--why wouldn't I be able to
22 use NIDA's marijuana? Is the reason I wouldn't be
0438
1 able to use NIDA's marijuana for these studies is
2 that I wouldn't have the guaranteed ability to
3 access that marijuana?
4 MR. PAREDES: Objection.
5 THE WITNESS: Yes, you have no right to
6 control it. You couldn't distribute it afterwards.
7 You--
8 JUDGE BITTNER: Okay; stop a minute.
9 THE WITNESS: Yes.
10 JUDGE BITTNER: We have an objection
11 pending. I think we need a rephrasing of the
12 question.
13 MR. HOPPER: Okay.
14 JUDGE BITTNER: As opposed to is the
15 reason--
16 BY MR. HOPPER:
17 Q What is the reason, Dr. Gieringer, that I
18 would not be able to use NIDA's marijuana to go
19 through the FDA approval process with the ultimate
20 goal of gaining approval?
21 A Well, you don't have the master file to
22 begin with. That is the property of, I guess, NIDA
0439
1 or its contractor, actually, and it's confidential
2 information. You don't even have that.
3 JUDGE BITTNER: Well, excuse me.
4 THE WITNESS: Yes.
5 JUDGE BITTNER: Do you know if NIDA has a
6 drug master file?
7 THE WITNESS: Either NIDA or the
8 contractor does. I forgot how it works; yes, there
9 is one. I asked once to see it, and I was told
10 that that's proprietary information.
11 JUDGE BITTNER: Okay; I'm showing my
12 ignorance of FDA requirements. Why do they need a
13 drug master file if there's no FDA product here?
14 THE WITNESS: Well, there is a
15 pharmaceutical product here, all right? Every
16 pharmaceutical product that is administered to
17 humans has to have some sort of a master file
18 describing it, you know, its properties to show
19 that it has what it has; that it is, you know, it's
20 manufactured safely and consistently and all of
21 these things.
22 JUDGE BITTNER: So NIDA would have to have
0440
1 that.
2 THE WITNESS: Yes.
3 JUDGE BITTNER: NIDA would have it.
4 THE WITNESS: Yes, they do have it.
5 JUDGE BITTNER: Okay.
6 BY MR. HOPPER:
7 Q Was CMCR ever intended to go through the
8 process of applying to the FDA for a new drug
9 application--
10 A No.
11 Q --for medical uses of marijuana?
12 A No.
13 Q Have any of the researchers funded or
14 supported by CMCR sought to apply for an NDA for
15 medical uses of marijuana?
16 A No.
17 Q Has the CMCR advisory council that you sit
18 upon ever proposed or discussed the idea of
19 applying for an NDA or undertaking the research
20 necessary to move marijuana through the FDA process
21 for approval as a prescription medicine?
22 A Never.
0441
1 Q Are you aware of the funding that was
2 provided for CMCR?
3 A Yes.
4 Q How much funding was provided?
5 A Three years of $3 million each, a total of
6 $9 million.
7 Q And to your knowledge, is any additional
8 funding contemplated from the legislature or any
9 other source at this time?
10 A No.
11 Q And do you know if anything remains from
12 that $9 million that was appropriated?
13 A No, it's all been committed to ongoing
14 studies.
15 Q So there are still some CMCR studies that
16 are underway now.
17 A They're almost all underway, really.
18 Q And so, those projects are underway;
19 they're funded, but there's no funding remaining
20 for additional new research projects beyond those
21 that are currently--
22 A That's right.
0442
1 Q --underway? Okay.
2 Based upon your knowledge of the FDA new
3 drug approval process and the CMCR, had the CMCR
4 desired to undertake that necessary research that
5 we were talking about to move marijuana through the
6 approval process, could it have done that?
7 A Well, it would have had to have
8 established its own garden, its own supply, to have
9 done that.
10 Q And was that idea ever discussed by CMCR?
11 A Yes; well, not by CMCR, but the idea was
12 discussed when we were working on the legislation
13 that was to become CMCR.
14 Q And what was the nature of those
15 discussions?
16 A Well, the idea was that we were going to
17 propose that California establish its own medical
18 marijuana garden to do research for CMCR.
19 JUDGE BITTNER: You mean to grow plants
20 for it.
21 THE WITNESS: To grow plants, yes, in
22 California with all the requisite permits that
0443
1 would be required to do that, yes.
2 BY MR. HOPPER:
3 Q And what was decided in that regard?
4 A In the end, that was turned down.
5 Q And instead, what was the source of
6 marijuana, then, that was to be used for all of the
7 CMCR studies?
8 A NIDA; well, actually, it says NIDA or if
9 NIDA doesn't supply the marijuana within six
10 months, then, the Attorney General of California
11 can supply confiscated marijuana or something like
12 that. But it was always intended that it would be
13 NIDA marijuana.
14 Q But there was a provision in the enabling
15 statute that sort of a fallback that there was
16 provision for using marijuana seized by law
17 enforcement in California?;
18 A Yes.
19 Q If NIDA didn't provide marijuana in a
20 timely fashion?
21 A Right.
22 Q And to your knowledge, were the CMCR
0444
1 researchers able to get marijuana from NIDA for
2 their research?
3 A Yes.
4 Q If CMCR's purpose was never to develop
5 marijuana into an FDA-approved medicine, which is,
6 it sounds like, what it would take in order to make
7 it available by prescription, then, what was the
8 purpose of the research? Why was CMCR established?
9 What was the purpose, and why--
10 A The purpose was to find whether marijuana
11 did indeed have medical uses; what those medical
12 uses might be; you know, what was its efficacy, in
13 other words, what safety drawbacks it might have
14 and the best way of administering it medically.
15 Pure knowledge quest.
16 MR. HOPPER: I have nothing further.
17 JUDGE BITTNER: Okay; cross.
18 CROSS-EXAMINATION
19 BY MS. PAREDES:
20 Q Yes, sir, Dr. Gieringer, has CMCR come out
21 with a solution for why they exist? In other
22 words, have they found out whether or not marijuana
0445
1 has medical uses?
2 A Well, as I say, there's about 15 studies
3 going on. Two of them, I am informed, are pretty
4 much complete and are waiting for publication, but
5 nobody is going to discuss the results of those
6 until they are published. Everything in due
7 course.
8 Q Okay; the National Advisory Council that
9 you are a member of for CMCR, what exactly is your
10 role on that council?
11 A Well, everybody pretty much has the same
12 role; you know, we have occasional meetings and
13 discuss ongoing research with the directors of the
14 center and give them advice on, you know,
15 appropriate course and what we think of what's
16 going on now.
17 Q And is the council's recommendations or
18 advice, is that by consensus, or do individual
19 members give their advice?
20 A Various people--there is no formal
21 decision making mechanism.
22 Q Doctor, are you aware if CMCR has pursued
0446
1 alternate funding?
2 A Yes, there has been some attempt to scare
3 up some alternate funding. In specific, I know
4 that last year, there was a conference at the
5 International Cannabinoid Research Society meeting
6 in Italy, there was a seminar that was put on by
7 CMCR with money from private pharmaceutical
8 companies concerning specifically cannabinoid
9 research as opposed to cannabis for marijuana
10 research; this was cannabinoid research.
11 And that came from private drug
12 developers, and I know there has been some interest
13 in CMCR in getting some outside funding from
14 pharmaceutical companies, specifically because I
15 don't think they see any more money coming from the
16 state anytime soon.
17 Q And to your knowledge, is there anything
18 concrete?
19 A No.
20 Q Doctor, were you part of or did you take
21 part in the litigation--well, are you familiar with
22 the Gonzales v. Raich litigation?
0447
1 A Yes.
2 Q And did you take part in that litigation
3 as California NORML?
4 A Not specifically. I think NORML filed an
5 amicus brief in that case.
6 Q And you personally, did you have any role?
7 A Not as--I'm not an attorney. I mean, I
8 helped with research. I helped the attorneys with
9 research on certain issues. They consulted me.
10 Q What kind of research?
11 A Oh, just background of marijuana and drug
12 regulation, regulatory issues, things like that.
13 Q And were you, yourself involved in the--are you
14 familiar with the Oakland Cannabis Supreme
15 Court case?
16 A I had pretty much the same relationship to
17 those litigants.
18 Q And was your role via NORML, or was that
19 in your personal capacity.
20 A I would say in my personal capacity?
21 MS. PAREDES: Nothing further.
22 JUDGE BITTNER: Could I just--before we
0448
1 have redirect, back on this drug master file issue.
2 THE WITNESS: Yes.
3 JUDGE BITTNER: Could you explain to me
4 what a drug master file is?
5 THE WITNESS: Well, it's the paperwork you
6 present to the FDA explaining your process for
7 producing the drug: the source of the drug, the
8 manufacturing process, you know, evidence of its
9 purity and quality control, proprietary
10 information, the kind of stuff that you might be
11 patenting, for example, if this is your own process
12 for producing aspirin or whatever, marijuana,
13 whatever it is, that sort of information. This is
14 how you make our drug and this is how we make our
15 drug.
16 JUDGE BITTNER: And that is considered
17 very proprietary by most drug companies, right?
18 THE WITNESS: Yes.
19 JUDGE BITTNER: So, and you started to say
20 something about you had asked to see the drug
21 master file for the NIDA marijuana--
22 THE WITNESS: Yes.
0449
1 JUDGE BITTNER: --and couldn't see it.
2 THE WITNESS: Right.
3 JUDGE BITTNER: So for a botanical--I
4 think you were here yesterday, weren't you?
5 THE WITNESS: Yes.
6 JUDGE BITTNER: And we had a little
7 discussion about what's a botanical. So for a
8 botanical product like marijuana, does the drug
9 master file include information like where the
10 seeds come from and how they're grown and how long
11 they're grown and--
12 THE WITNESS: How it's harvested, dried
13 afterwards, and yes, how it's rolled up into
14 cigarettes if that's what they're going to do with
15 it.
16 JUDGE BITTNER: So then, if NIDA changes
17 anything about how the marijuana is grown or
18 University of Mississippi changes it, then, that
19 file has to be updated.
20 THE WITNESS: Yes.
21 JUDGE BITTNER: So, then, could you--my
22 notes are unclear here--could you explain again
0450
1 why, if someone were to, say, purchase NIDA's
2 marijuana--
3 THE WITNESS: Right, we could purchase
4 their marijuana.
5 JUDGE BITTNER: --and wanted to develop a
6 drug product out of it.
7 THE WITNESS: Right.
8 JUDGE BITTNER: Leaving out all of the
9 other issues.
10 THE WITNESS: Okay.
11 JUDGE BITTNER: But assume that a
12 pharmaceutical company concludes--
13 THE WITNESS: Right.
14 JUDGE BITTNER: --that there is money to
15 be made here for whatever reason. So why couldn't
16 it use, because there is a drug master file on the
17 NIDA marijuana, why couldn't it use NIDA as its
18 source for the material and then develop its dosage
19 form?
20 THE WITNESS: They would have to make some
21 sort of an agreement with NIDA to do that, I
22 suppose. Since NIDA really controls the product,
0451
1 it would have to be NIDA's decision to do that.
2 JUDGE BITTNER: Right.
3 THE WITNESS: And then, you would sort of
4 be serving as the distributor for NIDA or something
5 like that. I suppose something like that would be
6 feasible, but it doesn't make any economic sense to
7 me, because it would depend on the foibles of NIDA,
8 you know. Selling somebody else's product, you
9 know, you can't control how much of it you'll get
10 or the price or anything else like that.
11 JUDGE BITTNER: But I guess what I'm
12 trying to get with is why, in theory--I can
13 understand practical problems, but why in theory
14 couldn't NIDA be the raw material supplier just
15 like any of the active pharmaceutical ingredient
16 manufacturers are?
17 THE WITNESS: In theory, if NIDA wanted to
18 do that, if NIDA were disposed to go along with
19 that, that might be doable.
20 JUDGE BITTNER: Okay.
21 THE WITNESS: Convoluted way of doing it.
22 JUDGE BITTNER: Right; but I keep going
0452
1 back to there is a drug master file.
2 THE WITNESS: Yes.
3 JUDGE BITTNER: Which would include the
4 protocol for growing the stuff.
5 THE WITNESS: Right, and it belongs to
6 NIDA or to El-Sohly Labs.
7 JUDGE BITTNER: Okay.
8 THE WITNESS: Their contractor.
9 JUDGE BITTNER: Okay; redirect.
10 MR. HOPPER: Thank you, Your Honor.
11 REDIRECT EXAMINATION
12 BY MR. HOPPER:
13 Q And just a couple of questions, and I
14 think I'd like to start with where Your Honor left
15 off. Dr. Gieringer, do you have the exhibits
16 there, the DEA Respondent's exhibits in the binder?
17 A Yes.
18 Q Can you turn and look at Exhibit No. 13?
19 A Yes.
20 Q Do you see that? It's a letter dated June
21 9th.
22 A I have seen this one before; yes.
0453
1 Q You're familiar with that letter.
2 A Mm-hmm.
3 Q And who's that addressed to?
4 A To Dr. Doblin.
5 Q And can you just--I'd like to draw your
6 attention to the second paragraph of that letter,
7 the fourth line, the first sentence that begins on
8 that fourth line, so after the end of that partial
9 sentence there. It begins it is not--
10 A It is not NIDA's role to set policy in
11 this area or to contribute to the DEA licensing
12 procedures.
13 Q The next sentence.
14 A Moreover, it is also not NIDA's mission to
15 study the medicinal--
16 MS. PAREDES: Objection.
17 THE WITNESS: --uses of marijuana or to
18 advocate for the establishment of facilities to
19 support this research.
20 JUDGE BITTNER: I'm sorry; wait a minute.
21 Do we have an objection?
22 Ms. PAREDES: Yes.
0454
1 JUDGE BITTNER: Okay.
2 MS. PAREDES: We're objecting on the basis
3 that it's outside the scope of the prehearing
4 supplement.
5 JUDGE BITTNER: Well, this is a little
6 awkward, since I started it.
7 [Laughter.]
8 MR. HOPPER: And I'm not going to go into
9 this in great detail, Your Honor. And this is an
10 exhibit that we're clearly going to be able to move
11 in later with Dr. Doblin's testimony, but I do
12 believe it is directly relevant to the question you
13 just asked Dr. Gieringer.
14 JUDGE BITTNER: Okay; well, actually, I
15 was only trying to get to the theoretical issue,
16 not the practical one. So I think we should leave
17 it right there.
18 MR. HOPPER: Very good. We'll talk about
19 that with the other testimony.
20 Just give me one moment, please.
21 [Pause.]
22 BY MR. HOPPER:
0455
1 Q All right; sorry for the delay.
2 Excuse me. Dr. Gieringer, you responded
3 to questions on cross-examination about the pursuit
4 of alternative funding, CMCR pursuing alternate
5 funding since it looks like they're not getting any
6 more money from the California legislature.
7 A Yes.
8 Q And you indicated that something about a
9 conference and that private pharmaceutical
10 companies were interested in the pursuit or
11 research involving cannabinoids.
12 A Correct.
13 Q Can you just explain a little bit for us
14 the distinction between researching cannabinoids
15 versus the whole plant as a medicine? I'm not sure
16 I understood the--
17 A Yes, well, the cannabinoids are the
18 chemical--they're chemical constituents of
19 marijuana. There's 62 cannabinoids known in
20 marijuana, and then, there's artificial
21 cannabinoids as well, and as they have been doing
22 research with the newly discovered cannabinoid
0456
1 receptors in the human brain, they're starting to
2 discover natural cannabinoids.
3 So there's this whole host of chemicals
4 known as cannabinoids now that are out there and
5 drug companies are developing products based on
6 these as pure chemicals, so they are synthesizing
7 one way or another these various cannabinoids and
8 trying to develop products that are chemical
9 products, pure chemical products, unlike marijuana
10 itself, the plant, the whole plant.
11 JUDGE BITTNER: So is everything that's a
12 chemical that's in marijuana considered a
13 cannabinoid? Or is it--I'm trying to get at what
14 is the definition of a cannabinoid?
15 THE WITNESS: Well, I can't give you the
16 exact chemical definition, but the basic--the
17 active, the primary, unique active elements in
18 cannabis are known as cannabinoids, the primary one
19 being delta-9-THC, and then, there's a whole bunch
20 of relatives and spinoffs of this--
21 JUDGE BITTNER: And they may or may not be
22 present in something else as well.
0457
1 THE WITNESS: Absolutely.
2 JUDGE BITTNER: Or chemically
3 synthesizable.
4 THE WITNESS: Every sample has its own
5 unique mix. Like the NIDA marijuana has only its
6 own unique profile of these cannabinoids.
7 JUDGE BITTNER: Right.
8 THE WITNESS: And so, many other kinds of
9 marijuana would have other mixtures of these
10 cannabinoids.
11 JUDGE BITTNER: But a cannabinoid could
12 happen to be present in something else as well.
13 THE WITNESS: Yes.
14 JUDGE BITTNER: Okay.
15 BY MR. HOPPER:
16 Q So is Marinol a synthetic--
17 A Yes.
18 Q --derivative of marijuana that is, as you
19 were just saying, it's synthesized, a cannabinoid
20 or mixture of cannabinoids?
21 A Yes, they tried to synthesize the major
22 psychoactive ingredient of cannabis, the delta-9-THC is the
0458
1 primary ingredient that was in Marinol,
2 and it's synthesized rather than extracted from the
3 plant.
4 Q And Marinol is a drug that is now
5 available by prescription.
6 A That's right.
7 Q And a private company markets Marinol; is
8 that correct?
9 A Yes.
10 Q And that private company apparently went
11 through the FDA approval process necessary to get a
12 new drug to market.
13 A Right.
14 Q And so, why didn't that private company
15 have the same problem that we've been talking about
16 in terms of having to have your own source of
17 marijuana?
18 A Because they could--
19 MS. PAREDES: Objection, foundation.
20 JUDGE BITTNER: Sustained.
21 Would you backtrack, please? Foundation
22 issue.
0459
1 MR. HOPPER: Sure.
2 BY MR. HOPPER:
3 Q Do you have some familiarity with how
4 Marinol is produced?
5 A Yes; vaguely, I'm not a chemist.
6 Q Well, basically that it's synthesized.
7 A Yes, it's synthesized, right.
8 Q And do you know whether the marijuana that
9 was synthesized or from which--back up a minute.
10 Was THC created in a laboratory rather than derived
11 from existing marijuana?
12 A Yes, for Marinol, that's true.
13 Q For Marinol. So Marinol was created
14 basically in a test tube. It wasn't pulled out of
15 existing marijuana.
16 A That's true.
17 Q So the company that put Marinol on the
18 market--
19 JUDGE BITTNER: You're getting leading.
20 You're heading right in that direction.
21 [Laughter.]
22 BY MR. HOPPER:
0460
1 Q Would the company that put Marinol on the
2 market have needed to obtain marijuana from NIDA in
3 order to do that?
4 A No, I don't think they ever did obtain any
5 marijuana from NIDA.
6 Q Because it was--
7 A They synthesized it--they had a patented
8 process for synthesizing THC.
9 Q So there is a distinct line of research in
10 production of medicine possible that is--
11 MS. PAREDES: Objection, leading.
12 JUDGE BITTNER: Yes, it is.
13 BY MR. HOPPER:
14 Q Is there--
15 A Is there what?
16 Q Based on what you've just told us, is
17 there a distinct line of research and production of
18 drugs possible that are based on cannabinoids and
19 other constituents of marijuana that don't require
20 extraction from a marijuana plant?
21 A Yes, there are other products under
22 investigation right now that are of that
0461
1 description, and they are not THC; they are other
2 kinds of cannabinoids that are being developed.
3 Actually, there's at least another one that's on
4 the market in England, anyhow, Nabilone, which is
5 sort of a pseudo-cannabinoid, artificial one.
6 Q So a pharmaceutical company wishing to
7 develop one of these into a drug like Marinol and
8 get it to market doesn't have to have a source of
9 marijuana.
10 A No, it does not, if it can synthesize it.
11 Q And you said that CMCR was exploring the
12 possibility of this type of research, cannabinoid
13 research.
14 A That would be privately funded. It would
15 have to be privately funded, because the mandate
16 for CMCR in the legislation only allows it to look
17 at marijuana. So with the state funding, it should
18 and could only look at natural marijuana, but if
19 they want to continue research in other areas with
20 private funding, they could look in this area of
21 general cannabinoid research.
22 Q So there is a financial motivation then
0462
1 for--
2 MS. PAREDES: Objection, leading.
3 JUDGE BITTNER: Sustained.
4 BY MR. HOPPER:
5 Q Is there, then, would there be a financial
6 motivation for CMCR to move to this type of
7 research as opposed to researching the whole plant?
8 A Oh, absolutely, yes.
9 MR. HOPPER: Okay; I have nothing further.
10 JUDGE BITTNER: Dr. Gieringer, before we
11 go into recross, are you in a position to describe
12 for me synthesis versus extraction?
13 THE WITNESS: Yes.
14 JUDGE BITTNER: Would you, please?
15 THE WITNESS: Well, yes, extraction: you
16 take some marijuana. You need some marijuana,
17 okay? And I only know of one place in the country
18 that you could get it but--
19 JUDGE BITTNER: Well, marijuana is not the
20 only plant that--
21 THE WITNESS: To get cannabinoids, to get
22 cannabinoids--
0463
1 JUDGE BITTNER: Well, I'm not talking
2 about cannabinoids. I'm talking about in general.
3 THE WITNESS: Well, okay, to take the
4 example of marijuana, you can process marijuana to
5 extract, say, the cannabinoids that you're
6 interested in, you know, by alcohol extraction or
7 any other number of chemicals, and you eventually
8 just take out the active constituents that you want
9 as some sort of extract from that plant, that
10 natural source.
11 With the synthesis, you start with a bunch
12 of chemicals that really have no relation to the
13 plant itself, and you put them together in a way
14 that you assemble them in a way so that you end up
15 with a product similar to what the plant produces.
16 JUDGE BITTNER: Okay.
17 THE WITNESS: Usually a more expensive way
18 of doing things.
19 JUDGE BITTNER: Recross.
20 RECROSS EXAMINATION
21 BY MS. PAREDES:
22 Q Doctor, would you agree that Marinol is a
0464
1 Schedule 3 controlled substance?
2 A Yes, it is.
3 Q And would you agree that the leafy plant
4 marijuana is a Schedule 1 controlled substance?
5 A So it is.
6 Q Okay; going back to the drug master files,
7 how familiar are you with pharmaceutical companies
8 filing drug master files?
9 A Well, I know it is done. I have not been
10 in the pharmaceutical industry myself.
11 Q Have you, yourself, ever filed one.
12 A No.
13 Q Have you ever otherwise worked on one?
14 A No.
15 Q Contributed?
16 A No, no.
17 Q Then, do you know if a drug master file
18 would include proprietary information?
19 A Yes.
20 Q You are familiar or--
21 A I know it contains proprietary
22 information, yes; that's the nature of it. People
0465
1 file these with the FDA in the hopes that
2 eventually, once it gets approved, they will have a
3 patent on it, and they want to keep it a secret, of
4 course, while--
5 MS. PAREDES: Nothing further.
6 MS. CARPENTER: We have nothing--sorry;
7 speaking out of turn.
8 MR. HOPPER: We have nothing further.
9 JUDGE BITTNER: Okay; thank you very much,
10 Doctor.
11 [Witness excused.]
12 JUDGE BITTNER: Do you want to quit for
13 the night?
14 MS. CARPENTER: Oh, Your Honor, we would
15 be delighted.
16 MR. HOPPER: I think that would be a
17 wonderful idea.
18 JUDGE BITTNER: Mr. Bayly, how is that
19 with you?
20 MR. BAYLY: Yes, that sounds like a good
21 idea, Judge.
22 JUDGE BITTNER: Oh, I always like to get
0466
1 the parties to agree on something. You're very
2 good at getting agreement quickly.
3 Okay; 9:00 is good for tomorrow morning?
4 [Whereupon, at 4:07 p.m., the hearing
5 recessed, to reconvene at 9:00 a.m. on Wednesday,
6 August 24, 2005.]
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