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1833
1 UNITED STATES DEPARTMENT OF JUSTICE
2 DRUG ENFORCEMENT ADMINISTRATION
3 - - - - - - - - - - - - - x
:
4 In the Matter of: :
: Docket No. 05-16
5 LYLE E. CRAKER, Ph.D. :
:
6 - - - - - - - - - - - - - x
7 VOLUME 9
8 Friday, December 16, 2005
9
10 DEA Headquarters
11 600 Army-Navy Drive
12 Hearing Room E-2103
13 Arlington, Virginia
14
15 The hearing in the above-entitled matter
16
17 convened, pursuant to notice, at 9:04 a.m.
18
19 BEFORE:
20
21 MARY ELLEN BITTNER
22 Chief Administrative Law Judge
1834
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
6 IMELDA L. PAREDES, ESQ.
7 Senior Attorney
8 Office of Chief Counsel
9 Drug Enforcement Administration
10 Washington, D.C. 20537
11 (202) 353-9676
12
13 On Behalf of the Respondent:
14
15 JULIE M. CARPENTER, ESQ.
16 Jenner & Block LLP
17 601 13th Street, N.W.
18 Suite 1200 South
19 Washington, D.C. 20005
20 (202) 661-4810
21
22 MR. JACOBOWITZ, ESQ.
1835
1 C O N T E N T S
2 WITNESS DIRECT CROSS REDIRECT RECROSS
3 Eric A. Voth, M.D. 1855 1919 1967 1972
4 David E. Auslander, M.D.
1974 2020 2029 2032
5
6
E X H I B I T S
7
EXHIBIT NOS. MARKED RECEIVED
8
GOVERNMENT'S
9
10 No. 25 -- 2038
11 No. 36 -- 1891
12 No. 40 -- 1883
13 No. 41 -- 1883
14 Nos. 53 and 53 -- 1841
15
16
17 RESPONDENT'S
18
19 No. 41 (in part) -- 2059
20 No. 54 (in part) -- 2044
21 No. 55 -- 1849
22 No. 57 -- 2053
1836
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. Mr. Bayly?
3 MR. BAYLY: Good morning, Judge Bittner.
4 Dr. Eric Voth is here, ready to testify, but we
5 have just a few evidentiary, or document submission
6 issues that I think we need to clear up. It
7 shouldn't be too long.
8 JUDGE BITTNER: Do you want to be on the
9 record or off?
10 MR. BAYLY: Oh, no, we definitely need to
11 be on.
12 JUDGE BITTNER: Okay.
13 MR. BAYLY: The first thing I'd like to
14 submit is Government 53. Wednesday, Judge Bittner,
15 you said this would be not admitted until we got
16 the contextual document to which 53 was responding.
17 I got that this morning. I'll give Your Honor a
18 copy.
19 JUDGE BITTNER: Okay.
20 MR. BAYLY: I just gave a copy to
21 Respondent's counsel just a few minutes ago. If
22 counsel needs more time to respond, that's fine,
1837
1 but I do want to say that when we admit what I've
2 marked now as 53A, I want to submit it for the
3 context of 53 without being for the truth of the
4 matter asserted necessarily therein. There are a
5 couple of reasons I say that.
6 This is a request by Americans for Safe
7 Access, so it's like a petition or like a brief, an
8 advocacy thing. If you look on page two, they lay
9 out the particular issues that they're complaining
10 about. Apparently, to give some context to the
11 process, there is a statute that allows certain
12 parties to have HHS, quote, "correct" documents
13 that they may put out as policy statements. They
14 may publish them in the Federal Register without
15 knowing the actual details of that statute.
16 The Americans for Safe Access in 53A made
17 a request for corrections of information, so they
18 disagreed with what HHS did. I think they refer to
19 some of the information put in the Gettman
20 petition. As you can see on pages one to two, the
21 issues that they raise go to the efficacy of
22 marijuana, the treatment of nausea, loss of
1838
1 appetite, pain, and spasticity. They talk about
2 whether the chemistry of marijuana is known and
3 reproducible, a consensus among experts. And then
4 the last issue that they want HHS to address is
5 marijuana has a currently accepted use in treatment
6 in the United States. I think that one was kind of
7 trumped by the statute.
8 In any event, I submit that if this does
9 go into evidence, to get Government Exhibit 53 into
10 evidence, that it should be just for its context as
11 opposed to getting into the merits of what's
12 written, and this request.
13 Of course, the other issue is, at this
14 point, I don't know if, one, if HHS made some kind
15 of ruling or finding on this, and two, if they did,
16 what it says. I don't know that we could really
17 trump whatever HHS says in that regard, anyway.
18 So that's my reason for wanting to qualify
19 the admission of 53A with 53.
20 JUDGE BITTNER: Ms. Carpenter?
21 MS. CARPENTER: Yes, two things. First of
22 all. We, I guess, spoke with the President of
1839
1 Americans for Safe Access yesterday and there has
2 been no action by HHS on this, so for what that's
3 worth.
4 Secondly, it seems to me what's good for
5 the goose is good for the gander. The response
6 that the Government wants to submit is the same
7 kind of information as is contained in the
8 petition. So if the Government if wants to accept
9 that not for the truth of the matter asserted, then
10 we'll accept the restriction on the first part.
11 But the Government can't have it both ways and have
12 only their section accepted for the truth of the
13 matter asserted and not what's in the petition, as
14 well.
15 JUDGE BITTNER: I may be corrected. My
16 vague recollection--after all, it was two whole
17 days ago--was that the point of getting Americans
18 for Safe Access's document, Government 53A, was to
19 provide the context for Government 53.
20 MS. CARPENTER: That's true, Your Honor.
21 JUDGE BITTNER: I mean, both of these--one
22 is from Americans for Safe Access. The other one
1840
1 is from G.W. Pharmaceuticals. Neither is a
2 disinterested party, right?
3 MS. CARPENTER: Quite right.
4 JUDGE BITTNER: I mean, nobody's going to
5 argue to the contrary. And so I'm not really--and
6 my recollection about Government 53 was that it
7 provided some explanation of side effects.
8 MS. CARPENTER: In addition to a number
9 of--a lot of other information, such as whether or
10 not their research would support herbal--marijuana
11 as an herbal medicine, and so--
12 JUDGE BITTNER: Right, but what I'm not
13 taking any of this for is back to the marijuana is
14 or is not medicine issue.
15 MS. CARPENTER: That's fine, Your Honor.
16 JUDGE BITTNER: Okay.
17 MS. CARPENTER: I just don't think half
18 the exhibit should be qualified if the other half
19 is not similarly qualified.
20 JUDGE BITTNER: I'm qualifying the whole
21 thing.
22 MS. CARPENTER: That makes sense.
1841
1 JUDGE BITTNER: With that, then,
2 Government 53 and 53A are received.
3 [Government's Exhibit Nos. 53
4 and 53A were admitted into
5 evidence.]
6 MR. BAYLY: Thank you, Judge Bittner.
7 JUDGE BITTNER: You're welcome.
8 MR. BAYLY: I was writing on the original,
9 so if you want to white it out or pretend it's not
10 there, I just--
11 JUDGE BITTNER: Okay.
12 MS. CARPENTER: Oh, that's the original?
13 I see.
14 MR. BAYLY: Yes, and I've got a yellow
15 copy here, a yellow stick-em copy for 53A.
16 Then, Judge Bittner, Wednesday and
17 yesterday, there were three new exhibits that the
18 Respondent has submitted and the reason I'd like to
19 clear that up now is because if any or some of
20 these are admitted into evidence, then we'd be
21 able--or we may be able to address them--I think we
22 can--with Dr. Voth and/or Dr. Auslander, although
1842
1 we don't want to waive the right to put in rebuttal
2 arguments, testimony, letters, what have you, since
3 we just got them either Wednesday or yesterday.
4 So at this point, I would request that we
5 go through these three exhibits and if the
6 Respondent could tender them for the purpose for
7 which they want to be admitted, and then I'd like
8 to have just a brief chance to respond. I've got
9 them marked--well, I'm sorry. I'll let you guys
10 take the ball.
11 MS. CARPENTER: Thank you.
12 JUDGE BITTNER: Are we having fun yet?
13 Ms. Carpenter?
14 MS. CARPENTER: Yes, Your Honor. That
15 would be Respondent's 54, 55, and then the one I
16 sent you yesterday, is that correct, Mr. Bayly,
17 which has not been marked yet? Is that what you're
18 talking about?
19 MR. BAYLY: I call it 56.
20 MS. CARPENTER: Okay. That would be my
21 inclination. And, Your Honor, let me give you a
22 copy of--
1843
1 JUDGE BITTNER: Fifty-four--
2 MS. CARPENTER: Fifty-four is the
3 testimony of Mr. Meyer, Dr. Meyer.
4 JUDGE BITTNER: Right.
5 MS. CARPENTER: Fifty-five is the letter
6 to Mr. Eggertson dated September 9 from Chemic
7 Labs.
8 JUDGE BITTNER: Okay. And I don't have
9 that, right?
10 MS. CARPENTER: You should have that, Your
11 Honor. I think we submitted that, or at least
12 marked it. No? Let me see if we've got--we'll get
13 copies of that.
14 JUDGE BITTNER: I don't think I've got it.
15 I don't have it in my book. Let's put it that way.
16 [Pause.]
17 JUDGE BITTNER: And then the other one is
18 56?
19 MS. CARPENTER: Yes, Your Honor, and I
20 have not given you that one yet.
21 JUDGE BITTNER: Okay.
22 [Pause.]
1844
1 MS. CARPENTER: And then let me just go
2 ahead and give you 56 so we can have them all.
3 [Pause.]
4 MS. CARPENTER: Respondent's Exhibit 54 is
5 the testimony by Robert J. Meyer with the FDA
6 before the House of Representatives on April 1,
7 2004. We had intended to cite this in our briefing
8 to you, and given what the Court has said about
9 having information in that's not readily
10 accessible, we thought it might make sense to go
11 ahead and try and put this in, recognizing that we
12 did not put it in the pre-hearing statement.
13 JUDGE BITTNER: Okay. And Mr. Bayly, what
14 was your position on 54?
15 MR. BAYLY: That perhaps in the brief,
16 this can be cited as legislative history. If it's
17 appended to the brief, then for convenience, that's
18 all right. But at this point, I would object to
19 this being admitted for the truth of the matter
20 asserted in the testimony on the timeliness. As
21 Ms. Carpenter pointed out, you can see the date is
22 April 1, 2004, and it looks like, I believe, this
1845
1 is one we got Wednesday, just this past Wednesday.
2 The other thing, this issue is always lurking, does
3 it get into this medical marijuana issue and is
4 marijuana--i.e., is marijuana a good medicine.
5 But in any event, I really do think it
6 should not be admitted as an exhibit. If it is,
7 and I really don't want it to be, but if it is
8 admitted, then, of course, the Government, being
9 that it just got this the day before yesterday,
10 would like a chance to rebut, supplement the
11 record, or what have you. But I think once these
12 things start getting in late, we start spinning out
13 of control and getting into rebuttal and
14 surrebuttal and what have you. So for that reason,
15 I would object to Respondent's 54.
16 JUDGE BITTNER: Ms. Carpenter? I wouldn't
17 consider it on the medical issue. We know that.
18 But on the timeliness issue, Ms. Carpenter?
19 MS. CARPENTER: Your Honor, we didn't know
20 it at the time, and we also, I think--this is in
21 part of rebuttal to what we anticipate Dr. Voth's
22 testimony will be. So if you want us to hold off
1846
1 and do it as rebuttal to Dr. Voth in terms of--then
2 we could do that, which is what we had planned to
3 do, so--
4 JUDGE BITTNER: All right. I am somewhat
5 more lenient on rebuttal because one doesn't know
6 exactly what the other party's case in chief is
7 going to be, so let's just hold off on this--
8 MS. CARPENTER: That's fine.
9 JUDGE BITTNER: --because it isn't timely.
10 That's my main problem with it.
11 MS. CARPENTER: I understand.
12 JUDGE BITTNER: Okay. With respect to
13 Respondent's 55--
14 MS. CARPENTER: Fifty-five--
15 JUDGE BITTNER: First of all, Mr. Bayly,
16 do you have any--since this obviously was not
17 available prior to our hearing beginning.
18 MS. CARPENTER: No, it was not, and it was
19 dated September 9, which was, as Your Honor will
20 recall, just before the second week of the hearing
21 was to begin, and so at the time, we thought we
22 would just be introducing at the hearing and would
1847
1 not file a supplemental. We had also assumed that
2 Mr. Bayly had seen this, since Mr. Eggertson was a
3 witness who was noticed and was to appear.
4 What this does is basically to complete
5 the record, if you will, with regard to the denial
6 of the Chemic protocol that Dr. Doblin testified.
7 We do have that denial in the record. We have Dr.
8 Doblin's response, or Dr. Chemic's response to Dr.
9 Doblin. This is simply Chemic's response to HHS
10 about that protocol, and I would submit it should
11 come in for that reason.
12 JUDGE BITTNER: Mr. Bayly?
13 MR. BAYLY: Well, aside from the
14 timeliness issue, putting that aside just for the
15 moment, it seems like this Chemic is what I'll call
16 a silent partner in this litigation and it is very
17 collateral. But I do realize that the denial came
18 in. So on this one, I will not argue timeliness,
19 but--
20 JUDGE BITTNER: That's probably good.
21 MR. BAYLY: Pardon?
22 JUDGE BITTNER: That's good.
1848
1 MR. BAYLY: Oh, okay. Well, it might make
2 it a little easier. But I certainly don't want to
3 waive the Government's right to argue and give
4 notification to Respondent that we are going to
5 object on a number of grounds, probably more in
6 detail in the brief, since you probably don't want
7 to listen to me too much here today. We want to
8 get the witnesses on and off. But it is a
9 collateral issue, it's not a DEA issue, and there
10 are other problems with this. So with that, I will
11 ask the Judge for a ruling.
12 JUDGE BITTNER: Okay. I'll overrule the
13 objection because I think since it wasn't available
14 earlier, there's not a timeliness question, and I
15 think it does pertain to some of the testimony that
16 we've heard from the Government. But I do have a
17 problem, which is I don't know what all these
18 abbreviations mean. There's a bunch of them in the
19 letter. So I would ask the parties to stipulate
20 what they are so that I don't have to guess.
21 MS. CARPENTER: Okay.
22 JUDGE BITTNER: So with that, I will
1849
1 receive Respondent's 55.
2 [Respondent's Exhibit No. 55
3 was admitted into evidence.]
4 JUDGE BITTNER: And 56?
5 MS. CARPENTER: Fifty-six, Your Honor, is
6 a letter that was sent yesterday, and it's on the
7 very same subject. It was sent by essentially a
8 peer reviewer of the Chemic protocol, and again, it
9 was not available until yesterday and we would
10 simply add that to the Chemic pile.
11 And with regard to the argument that it's
12 collateral, I think in our view, it is not
13 collateral. MAPS has been trying to do research
14 using marijuana from NIDA in a number of different
15 ways, some of them clinical, some of them using
16 this vaporizer, which is an important part of the
17 research, and they have not been able to get it.
18 So in that sense, it's not collateral at all. It's
19 a clear indication of the difficulty of researchers
20 getting marijuana to do research.
21 JUDGE BITTNER: Mr. Bayly?
22 MR. BAYLY: Big problem with this.
1850
1 Definitely timeliness, and this looks like it's for
2 the purpose of litigation. It's not one of those
3 documents where you're waiting interminably for an
4 agency to come out with something and you have no
5 control. This is a document that is solicited to
6 litigate this Chemic issue, and if you look at the--and I do
7 appreciate the Respondent putting in this
8 fax cover sheet. It shows where it comes from--
9 JUDGE BITTNER: Actually, I don't have a
10 fax--it's an e-mail cover sheet, right?
11 MR. BAYLY: I'm sorry.
12 MS. CARPENTER: Right.
13 JUDGE BITTNER: Okay. I just want to make
14 sure we all have the same thing.
15 MR. BAYLY: I get e-mail and faxes mixed
16 up. I guess I'm old fashioned in that regard. But
17 at any rate, reading the letter, it is addressed to
18 Mr. Eggertson, and I think he's the fellow that did
19 write the letter to Chemic and then Chemic wrote
20 back to Eggertson, but this is somebody that is
21 clearly just jumping into the litigation and there
22 was no reason that we have on the record why this
1851
1 person had to do it December 15.
2 The Chemic rejection letter from Joel
3 Eggertson was dated July 27, '05, and I realize we
4 put that into evidence because maybe Chemic didn't
5 disclose it until right before the August hearing,
6 but we've got this Chemic issue is on the table
7 since mid- or, I guess, the latter part of August,
8 when we had the first hearing, and this is, of
9 course, very much sought to be admitted to support
10 the Chemic position. And so we've got--this should
11 not come in on timeliness and for what it's
12 tendered for.
13 JUDGE BITTNER: Ms. Carpenter?
14 MS. CARPENTER: Yes, ma'am. We had
15 extensive testimony yesterday from Dr. Gust about
16 the back and forth between the PHS Committee and
17 that how when the PHS Committee denies something,
18 it's not really denied. They're issuing an
19 invitation for back and forth.
20 This is a peer review, which takes quite
21 some time to get somebody to agree to in the first
22 place, and then sometime to accomplish. It's a
1852
1 peer review rebuttal of the comments that Mr.
2 Eggertson and the PHS Committee made about the
3 Chemic protocol. So this is--Mr. Bayly's
4 assumptions notwithstanding, this was designed to
5 address the Chemic issue before the PHS Committee.
6 It was not gotten for litigation purposes. Even if
7 it were, I'm not sure that would disclude it or
8 disqualify it.
9 But the point is, this was filed
10 yesterday. We had no control over the peer
11 reviewer, when they would finish their research or
12 when they would write the letter. They sent it
13 yesterday. It can hardly be a timeliness problem,
14 Your Honor.
15 JUDGE BITTNER: My concern is if we put
16 this in, then it seems like I'd need the entire
17 Chemic file. In other words, we have a letter in
18 support of Chemic. We don't know what else. I
19 feel like I'm getting part of what Mr. Eggertson
20 got, and I don't know what else he got and I don't
21 really want to get into that.
22 MS. CARPENTER: Part of what Mr. Eggertson
1853
1 got from who?
2 JUDGE BITTNER: In other words, what we
3 have is, if I recall correctly--
4 MS. CARPENTER: A denial from Mr.
5 Eggertson.
6 JUDGE BITTNER: Right. And now we've got
7 Chemic's response, which I just received.
8 MS. CARPENTER: And then a peer review of
9 that protocol.
10 JUDGE BITTNER: And I guess what I'm
11 concerned about is I don't see anything in
12 Respondent's 56 saying that it's a peer review.
13 What we've got is Dr. Hasecamp saying, I support
14 Chemic, but it doesn't appear to have been
15 solicited by the PHS Committee.
16 MS. CARPENTER: No, certainly not, Your
17 Honor. It was solicited by Chemic in order to
18 establish to the PHS Committee that their critiques
19 were--
20 JUDGE BITTNER: Right, and so what I'm
21 concerned about is I don't know what else there
22 might be. In other words, we've got a letter in
1854
1 response to a solicitation from Chemic. I don't
2 know what else--I mean, I'm not going to second-guess HHS.
3 MS. CARPENTER: Certainly not.
4 JUDGE BITTNER: I guess what I'm trying to
5 say is I don't see what this letter adds to the
6 record that wouldn't require me to have every other
7 letter. I mean, Chemic's response makes sense. To
8 have it in evidence makes sense to me. But to have
9 somebody now coming forward right now, three months
10 after Chemic's response to Mr. Eggertson, saying,
11 oh, by the way, I support Chemic, it just doesn't
12 help me any, I don't think.
13 MS. CARPENTER: I would just represent for
14 the record, Your Honor, I don't believe there are
15 any other letters, so I think this is the complete
16 package, certainly in terms of what Chemic--
17 JUDGE BITTNER: Well, at this point, I
18 will reject it but will keep it in the file and
19 send it to the Deputy Administrator.
20 MS. CARPENTER: Thank you, Your Honor.
21 JUDGE BITTNER: So 56 is rejected, but I
1855
1 won't read it, but I'll hang on to it.
2 MR. BAYLY: And if I may add one more
3 ground for the objection, because they may appeal
4 it to Your Honor, as well as the Deputy
5 Administrator, using the generic term "rebuttal"
6 doesn't mean that you can get in documents late.
7 It just doesn't work that way. Otherwise, this
8 process never stops, because certainly, given that
9 we got this yesterday, and if it did come in, we
10 certainly would want to rebut it, so we want to
11 preserve that argument, as well.
12 With that, we're finally ready to call Dr.
13 Eric Voth, please.
14 JUDGE BITTNER: Okay. Doctor?
15 Whereupon,
16 ERIC A. VOTH, M.D.
17 was called as a witness, and after being first duly
18 sworn, was examined and testified as follows:
19 JUDGE BITTNER: Please be seated. There
20 should be water in the carafe there.
21 DIRECT EXAMINATION
22 BY MR. BAYLY:
1856
1 Q Please say your name for the record.
2 A Eric A. Voth, M.D.
3 JUDGE BITTNER: And would you spell both
4 your first and last name for me?
5 THE WITNESS: First name is E-r-i-c, and
6 last name is V as in Victor-o-t-h.
7 JUDGE BITTNER: Thank you.
8 MR. BAYLY: Your Honor, I'd like to
9 present the witness with Government Exhibit 33.
10 That's the CV for Dr. Voth. I don't think we have--no, we
11 have not admitted it yet.
12 JUDGE BITTNER: I think that's correct.
13 Yes, we did. No, wait a minute. That's not
14 Government 33. I'm sorry. What number was it, Mr.
15 Bayly?
16 MR. BAYLY: Thirty-six.
17 JUDGE BITTNER: Ahh, okay. Thirty-three
18 is admitted, but it's not the right exhibit.
19 Thirty-three has not been offered. Ms. Carpenter?
20 MS. CARPENTER: Thirty-six, Your Honor?
21 JUDGE BITTNER: Yes. You haven't actually
22 offered it yet. Does the witness have it?
1857
1 MR. BAYLY: Yes. We'll go through it in a
2 minute, here.
3 BY MR. BAYLY:
4 Q Start from the face, Dr. Voth, of your CV.
5 We've always had to clarify this in the past, so I
6 see no reason to change our protocol here, but what
7 does M.D. stand for?
8 A It's medical doctor, physician.
9 Q And then we see the initials F.A.C.P. on
10 the face of your CV. Can you tell us what that
11 stands for and what it means?
12 A That stands for Fellow of the American
13 College of Physicians.
14 Q Does that have anything to do with board
15 certification?
16 A No, not really. The Fellowship in the
17 American College of Physicians is bestowed by the
18 American College of Physicians essentially for
19 academic and professional accomplishments.
20 Q All right. And can you tell us why you
21 have this designation, what your accomplishments
22 are, just generally?
1858
1 A More or less, this is a nomination by
2 peers and then looked at by the Fellowship
3 Committee at the American College of Physicians
4 relative to academic accomplishments, teaching
5 accomplishments, professional accomplishments,
6 those kind of things. I think that most of what
7 they looked at in that regard was my work in drug
8 abuse.
9 Q Right now, I'd ask you to turn to page
10 three, please, of your CV. It's marked both on the
11 top and the bottom of the right--
12 A Yes, I have it.
13 Q We see that--I want to refer you to the,
14 quote, "Board certification, American Board of
15 Internal Medicine, 1985." Can you tell us what
16 Board certification means?
17 A Board certification for internal medicine
18 is a process that's been set up by the Academy,
19 more or less, that sets up a testing process, and
20 if you pass that testing, then you become board
21 certified.
22 Q Is you Board certification current?
1859
1 A Oh, yes.
2 Q I'd like you to flip back to page two.
3 A Okay.
4 Q The CV bio summary starts out, "Dr. Voth
5 is a specialist in internal medicine and addiction
6 medicine, working at Stormont-Vale Health Care in
7 Topeka, Kansas." First of all, can you just give
8 us a general description, Dr. Voth, of your
9 internal medicine practice?
10 A Sure. About two-thirds to 70 percent of
11 my time is in the practice of internal medicine,
12 which for all intents and purposes is adult
13 medicine, taking care of heart disease, lung
14 disease, cancer, that kind of thing. I don't do
15 surgery and I don't deliver babies and really don't
16 take care of young children, but other than that,
17 it's more or less adult medicine. And that's the
18 internal medicine part of it.
19 The addiction medicine part has been kind
20 of a broad spectrum of areas. That involved
21 actually being the medical director of a chemical
22 dependency unit for ten years. I continue to do
1860
1 consultation, recommend treatment, detoxification
2 and a lot of drug policy work.
3 Q Have then you in your practice actually
4 treated patients for either addiction or abuse of
5 controlled substances?
6 A Oh, yes, certainly.
7 Q Can you give us an estimate of how many
8 patients you've treated in this regard?
9 A Well, when I finally quit counting, it was
10 about 4,000. We used to keep pretty close track of
11 that for some period of time, and since probably
12 the early '90s, I've not actually tracked that. So
13 at least 4,000, but certainly more than that by
14 now.
15 Q Now, these patients that you testified
16 about, Dr. Voth, have they entailed patients who
17 have had either abuse or addiction problems with
18 marijuana?
19 A Certainly, yes, they have.
20 Q Can you give an estimate of about how many
21 of all these various patients that you have treated
22 for abuse or addiction had marijuana issues?
1861
1 A It's a little hard to guess, but as a
2 general guess, since we didn't track it in those
3 kind of terms, about half of them had some element
4 of marijuana abuse, whether that was along with
5 other drugs or primary marijuana abuse, and
6 somewhere in the neighborhood of, say, a quarter,
7 roughly, would have been strictly marijuana abuse.
8 Q Let me just ask you, when did you first
9 become interested in studying marijuana?
10 A Well, probably well back into the '70s,
11 even in college, before I was involved in medicine.
12 Q Have you become familiar with marijuana
13 research issues, as well?
14 A Most certainly. Absolutely. I started
15 really paying close attention to that in probably
16 the mid-'70s.
17 Q Okay. So when did you start learning
18 about marijuana research?
19 A I think it would be safe to say around
20 1974, 1975, really started closely studying and
21 following marijuana research.
22 Q Have you ever studied marijuana policy
1862
1 issues?
2 A Absolutely, yes.
3 Q And how long have you studied marijuana
4 policy issues?
5 A Pretty much hand-in-hand that whole time,
6 following the research and also the drug policy
7 issues and implications, so probably since
8 certainly the mid-'70s, about 30 years.
9 Q All right. Now, Dr. Voth, I'd like you to
10 please turn to page four.
11 A Okay.
12 Q Listed under positions held, we see
13 Chairman, Institute on Global Drug Policy.
14 A Right.
15 Q My first question is, when was this
16 Institute founded?
17 A I actually helped found that Institute in
18 the year 2000.
19 Q And what is the Institute's function?
20 A The best way to characterize it is that
21 we're really a drug policy think tank.
22 Q What is the role in the Institute? What
1863
1 is your role in the Institute?
2 A Well, I'm Chairman of it, and as such, I
3 try to organize policy issues, statements, put
4 together position papers, those kind of things. I
5 guess I also work on putting membership together
6 and recruiting new members, that kind of activity.
7 Q All right. I'm now still on page four,
8 Dr. Voth, of your CV, dna if you could just very
9 briefly give us an idea of what you did as a
10 Clinical Associate Professor of Internal Medicine,
11 Department of Medicine, University of Kansas School
12 of Medicine, 1999 to current? That's about the
13 sixth one down on positions held. Do you see that
14 one?
15 A Yes, I do.
16 Q All right.
17 A As a Clinical Associate Professor, that's
18 more or less a clinical teaching position. I may
19 have residents or medical students or various
20 students from the university working with me,
21 rotating with me for part of their educational
22 processes.
1864
1 Q All right. Next, I'd like to briefly
2 describe your duties or what you do on number nine,
3 and that's the--I've listed it as nine, they're not
4 numbered, but I'll quote it so we know where we're
5 at--alcoholism and drug abuse consultant, Kansas
6 State Board of Healing Arts, current.
7 A With some regularity, our State Board of
8 Healing Arts may have issues involving physicians
9 and their use or handling of alcoholism issues or
10 drug abuse issues, or for that matter, physicians'
11 individual problems, so a physician may be addicted
12 to some substance and how to deal with them.
13 Q And then drop down two more. I think I've
14 got it numbered as 11, but let me quote it here.
15 It's the consultant, National Institute of Drug
16 Abuse, Epidemiology, and Preventative Review. Can
17 you tell us what this organization is and what your
18 duties or functions are in relation to it?
19 A Those functions were actually back in the
20 probably mid- to late '80s when I served on
21 committees to oversee some of the grants that NIDA
22 was looking at relative to prevention programs and
1865
1 maybe even some treatment programs at that point in
2 time. But that was probably two to three years,
3 I'd say, in the mid- to late '80s.
4 Q Okay. So how long were you on this
5 committee, then?
6 A I think it was two to three years. I've
7 not been involved since the late '80s.
8 Q I'd like to ask you now to please flip
9 back to page three of your CV there, Government
10 Exhibit 36. It looks like it's the next-to-last
11 entry there on page three, Dr. Voth. I'll quote it
12 so we make sure we're all together on this.
13 "Member, Advisory Committee, Centers for Substance
14 Abuse Treatment, U.S. Health and Human Services
15 Administration, 2003-," end quote. First of all,
16 can you tell us what this committee is?
17 A Right. The National Advisory Committee
18 for--this is CSAT, or Centers for Substance Abuse
19 Treatment, oversees virtually all the grants that
20 the Centers for Substance Abuse Treatment hands
21 out. We look at research, kind of the general
22 direction for the Centers for Substance Abuse
1866
1 Treatment. And this also, just parenthetically,
2 was appointed by the Secretary of Health and Human
3 Services.
4 Q And Dr. Voth, what do you do in your
5 capacity as an advisor for this committee?
6 A Oh, we attend a number of meetings and
7 also do a lot of grant review, looking at research
8 grants and also treatment grants to communities and
9 different organizations for drug abuse treatment.
10 Q Now, I'd like to ask you to please flip
11 back to page four, and I'm on entry number 12, so
12 let me quote that so that we are all on the same
13 page, so to speak. Quote, "member and former
14 Chairman, Committee on Impairment and Advocacy,
15 Kansas Medical Society." First of all, tell us
16 when you were the Chairman of the Committee.
17 A That was roughly the early '90s, about
18 roughly 1990 or 1992, along in there. There were a
19 couple of years when I sat in oversight of that
20 Committee, which is essentially in some States
21 called the Physician Impairment Committee or the
22 committee that liaisons with physicians that have
1867
1 chemical dependence problems and help them get
2 treatment and that kind of thing.
3 Q And are you now a member of this committee
4 still?
5 A Yes, I'm still involved, but I'm not
6 Chairman.
7 Q And, first of all, tell us--just describe,
8 please, what your function was on this committee,
9 first of all, as Chairman.
10 A Probably the best way to describe that
11 would be coordinating services for impaired
12 physicians, so if a physician was reported, rather
13 than reporting to the State Board of Healing Arts,
14 Kansas allows physicians to be able to be reported
15 to this committee. We would then establish an
16 intervention or evaluation and see about arranging
17 treatment for them and follow-up services and then
18 reintroduction back into practice.
19 Q Next, Dr. Voth, I'd like to refer you to
20 the next entry on page four. That's the Chairman,
21 St. Francis Stormont-Vail Hospital, Physician
22 Impairment and Advocacy Committee, 1990 to 1994, as
1868
1 well as take you over to page six. I think the
2 cross-reference there would be the last one, or the
3 last two, I think. Page six, Chairman, Physician's
4 Health and Advocacy Committee, Stormont-Vail, 2002
5 to current, and Chairman, Physician Risk Management
6 Committee, Stormont-Vail, 2003 to current. Those
7 three entries, can you tell us, describe what you
8 do for those?
9 A The involvement for the Impairment and
10 Advocacy Committees was pretty similar to that
11 Kansas committee. In other words, if a physician
12 has a chemical dependency problem, it's our job to
13 deal with that and help them get treatment or
14 intervene on them and then see to it that they're
15 reinstituted back into practice.
16 The Risk Management Committee is a little
17 more along the lines, really, in terms of looking
18 at physician practice patterns, behaviors, things
19 that might result in litigation or malpractice
20 cases, those kind of things.
21 Q All right. Thank you. Now, I'd like you
22 to move to page five and look at the entries. I'm
1869
1 going to kind of roll these into one here to
2 expedite things. But if you'll look on page five
3 at the entries, the first one is book reviewer for
4 the American Journal of Addiction, 1994-dash-current. And
5 then we go down to six and the last
6 one is peer reviewer, Archives of General
7 Psychology--Psychiatry, excuse me--2004 to current.
8 Can you describe what your duties or what you do in
9 terms of the book reviews and peer reviews for
10 these journals that you've listed that I've noted
11 on page five of your CV?
12 A These journals are all major medical
13 journals and my review there, or my function there
14 is when papers are submitted to these journals,
15 they are then--I will be sent papers to evaluate
16 for their content, for their usefulness to be
17 published, et cetera, and then comment back to the
18 editor about accepting them or changing them or
19 that kind of thing. So this is really--when you
20 term a peer review journal, I'm serving as a peer
21 reviewer for those journals.
22 Q Dr. Voth, have you been a consultant and
1870
1 reviewer for the National Academy of Sciences?
2 A Yes, I was.
3 Q And what was the function of that
4 organization in relation to marijuana?
5 A In 1997, they came out with the big review
6 called the IOM Study that has been referred to
7 relative to medicinal uses of marijuana. I was a
8 consultant to that review, testified to it and also
9 was a reviewer of the final product of the IOM
10 Study.
11 MR. BAYLY: Your Honor, I'd like the
12 witness to be shown Respondent's Exhibit 1, and
13 I'll absolutely promise I'm not going to have him
14 go through that.
15 [The document was shown to the witness.]
16 BY MR. BAYLY:
17 Q Thank you. But for the record, Dr. Voth,
18 I want to ask you if this--if you just look at the
19 cover sheet and maybe peruse the first few pages,
20 the title page, what have you, and ask if this is
21 the study that you're referring to.
22 A Yes, it is.
1871
1 Q All right. Thank you. I guess you can
2 put that aside now and back to some of these peer
3 review and book review functions that you've listed
4 on your CV. Did any of these articles you review
5 pertain to marijuana?
6 A Yes, some have.
7 Q Did any of these articles you review
8 pertain to marijuana abuse and addiction?
9 A I believe so. I don't recall
10 specifically, but I generally believe that to be
11 the case, yes.
12 Q And any of these articles you review
13 pertain to marijuana's potential medical use?
14 A Yes, I believe they have.
15 Q And in the course of these peer reviews,
16 have you reviewed marijuana in terms of its
17 constituents and its use and abuse?
18 A Oh, certainly. Yes.
19 Q All right. And I'm going to ask you--let's see, I
20 think we're still on page five. The
21 entry there, it looks like it's the third from the
22 bottom, Consultant to the International Task Force
1872
1 on Strategic Drug Policy sponsored by the United
2 States Department INL and Drug Prevention Network
3 of the Americas, 2001 to current. First, in regard
4 to that entry, what does INL stand for?
5 A It stands for International Narcotics and
6 Law Enforcement.
7 Q And can you tell us what your function is
8 in this organization, Dr. Voth?
9 A In a general sense, we have provided drug
10 policy recommendations and review of drug policy in
11 various parts of the world and may make
12 recommendations about changes or processes that are
13 taking place in various countries.
14 Q And I'd like to refer you to page seven,
15 where you've listed some of your scientific
16 publications.
17 A Correct.
18 Q Are some of these articles--do they
19 pertain to marijuana?
20 A Yes, some of them do.
21 Q Are the articles listed here under this
22 section here, are they subject to peer review?
1873
1 A Most of them are subject to some form of
2 peer review. Letters to the editor would be
3 reviewed by an editor. They may or may not
4 actually go out to a specific peer reviewer. The
5 papers listed certainly are under peer review.
6 MR. BAYLY: Your Honor, I'd like the
7 witness to be given Government Exhibits 38 and 40.
8 MS. CARPENTER: She doesn't have them.
9 MR. BAYLY: I'm sorry, we've got them. If
10 I may approach. Thirty-eight--I think we're going
11 to hold off on 38, but I'm going to at least ask
12 Dr. Voth about Government Exhibits 40 and 41, so
13 I'd like to give Dr. Voth these exhibits.
14 JUDGE BITTNER: Okay.
15 [The documents were shown to the witness.]
16 BY MR. BAYLY:
17 Q Dr. Voth, I've just given you Exhibits 40
18 and 41. Can you, first of all, identify those
19 exhibits for the record?
20 A Exhibit 40 is titled "Medical Marijuana:
21 A Survey of Teenagers and Their Parents," by Dr.
22 Richard Schwartz. And 41 is "The Use and Toxicity
1874
1 of Cannabis in Teenagers," by Dr. Richard Schwartz
2 and co-authored by me.
3 MR. BAYLY: Your Honor, I'd like to
4 introduce Exhibits 40 and 41 into evidence.
5 JUDGE BITTNER: Ms. Carpenter?
6 MS. CARPENTER: Let me just check 41, Your
7 Honor. I'm sorry.
8 [Pause.]
9 MR. JACOBOWITZ: We accept that with the
10 note that we had previously discussed this exhibit
11 and I believe Your Honor has ruled that it is
12 excluded to the extent that it discusses the risks
13 of cannabis smoking.
14 JUDGE BITTNER: No, I don't think so. I--
15 MR. JACOBOWITZ: That may overstate it a
16 little. I'm sorry.
17 JUDGE BITTNER: Whatever I ruled, I'll
18 probably still rule, we hope. But I'm a little
19 unclear. Mr. Bayly, do you have someplace a cover
20 sheet from the journal or something so I can cite
21 it correctly if I need to, or is it in your exhibit
22 list cited?
1875
1 MR. BAYLY: Was it listed as an exhibit?
2 Yes.
3 JUDGE BITTNER: Okay. So Clinical
4 Pediatrics was 40 and Advances in Pediatrics--is
5 this a book or a journal or part of a book, with
6 respect to 41?
7 MR. BAYLY: Could I ask--could the witness
8 address that?
9 JUDGE BITTNER: Sure.
10 THE WITNESS: That was part of--I think
11 that was a chapter in a larger book, Recent
12 Advances in Pediatrics.
13 JUDGE BITTNER: Okay.
14 THE WITNESS: The chapter was, "The Use
15 and Toxicity of Cannabis in Teenagers" on this
16 cover sheet.
17 JUDGE BITTNER: Okay. Then--
18 MS. CARPENTER: Your Honor?
19 JUDGE BITTNER: I'm sorry?
20 MS. CARPENTER: I should be clear about
21 something first. Mr. Jacobowitz is going to be
22 doing the cross-examination today of Dr. Voth.
1876
1 JUDGE BITTNER: Okay.
2 MS. CARPENTER: If I may, could I just
3 make one objection, and then I'll not make any more
4 the rest of the time.
5 JUDGE BITTNER: Mr. Bayly, do you have any
6 objection to Ms. Carpenter making an objection when
7 she's not cross-examining the witness?
8 MR. BAYLY: I object to the objection.
9 [Laughter.]
10 MR. BAYLY: No, I don't.
11 JUDGE BITTNER: Okay. Thank you. Go
12 ahead, Ms. Carpenter.
13 MS. CARPENTER: This is just, I think, to
14 set a groundwork for where we're going today. I
15 guess for the record we should say we do object to
16 Government's Exhibit 41, and the reason is that
17 Your Honor has excluded evidence relating to the
18 therapeutic uses and the risks of marijuana use
19 with regard to medical marijuana. This testimony
20 is one-half of that equation. You're now allowing
21 testimony as to the risk of using marijuana,
22 although it sort of comes in, I guess, under the
1877
1 abuse, which I presume is relevant to diversion,
2 and I guess I'd like to talk a little bit about
3 that.
4 So two objections. One is that it allows
5 in evidence that Your Honor had previously excluded
6 and only one-half of that evidence, so that what's
7 now before Your Honor are only the risks, whether
8 it's medical use or otherwise, and not the other
9 side of that evidence, which would be the benefits
10 of medical use.
11 The second part of it is I understand, and
12 Mr. Bayly can correct me if I'm wrong, that his
13 notion is that this is relevant to diversion.
14 Maybe you should just be clear about that now. Is
15 that correct, Mr. Bayly?
16 MR. BAYLY: That's one reason for
17 admitting it, not necessarily the only one, but
18 yes, definitely.
19 JUDGE BITTNER: Okay. And the other or
20 others is/are? Reasons for admitting.
21 MR. BAYLY: As I recall, these were not--there was
22 a motion in limine filed by Respondent
1878
1 and these were not rejected under that motion, but
2 there's a couple of reasons. Number one, it goes
3 to diversion, and number two, it goes to abuse, and
4 those issues are definitely on the table. I think
5 as with the case of the IOM report, Judge Bittner,
6 if some of these admissible exhibits do spill over
7 into the issue that marijuana as a herbal plant, or
8 any other form, I suppose, is good medicine and
9 should be rescheduled as Schedule I, then certainly
10 we would have to say that any and all exhibits are--can't
11 and shouldn't get into that issue.
12 MS. CARPENTER: Well, I guess similarly, I
13 would say that can't and shouldn't get into the
14 issue of that it is bad medicine and shouldn't be
15 used because of the risks, and that seems to be
16 exactly the point.
17 JUDGE BITTNER: Okay. First of all, let
18 me see if I can find what I did. This is all--well, in
19 theory, it's useful.
20 [Pause.]
21 JUDGE BITTNER: I have the Government's
22 objections. Where are Respondent's?
1879
1 [Pause.]
2 JUDGE BITTNER: Okay. Let's see.
3 [Pause.]
4 JUDGE BITTNER: Well, I'm confused. This
5 is bad. We don't want me confused. The reason I'm
6 confused is the reference that I have to Government
7 Exhibit 41 was the Government's motion back in July
8 to file it two days late, which is not the issue we
9 have right now. Was there an objection to it back
10 then?
11 MS. CARPENTER: I don't--to them filing it
12 late?
13 JUDGE BITTNER: No, no, no. I'm just
14 saying that's the only reference I have. I didn't
15 mean to get off on a tangent here.
16 MS. CARPENTER: No, I don't think so. I
17 think this comes in from Your Honor's order back
18 in, what was it, July, where the Government had
19 moved to exclude much of our evidence and Your
20 Honor held that rescheduling was not before the
21 Court and so you were not going to hear evidence
22 about the therapeutic benefits or the risks of--
1880
1 JUDGE BITTNER: The August 12 memo--
2 MS. CARPENTER: --medical use, and based
3 on that, we then talked to Mr. Bayly and to Ms.
4 Paredes and this is one of the documents that we
5 thought ought to be removed. They did not. I
6 think we then moved to exclude--did we include this
7 one in a motion to exclude?
8 MR. JACOBOWITZ: I thought we had.
9 MS. CARPENTER: But in any event--
10 JUDGE BITTNER: That's what I'm not
11 finding. It doesn't mean you didn't do it. I just
12 haven't found it.
13 MR. BAYLY: If I may hopefully add some
14 elucidation to this, what I'm looking at is
15 Respondent's motion to exclude some of the
16 Government's proposed testimony and exhibits. So
17 that was the Respondent's--
18 JUDGE BITTNER: And when was that? Do you
19 have a date on that?
20 MR. BAYLY: --and then, even better yet,
21 to find your order on that. But this--Respondent
22 filed the motion September 16, 2005.
1881
1 JUDGE BITTNER: Oh, okay. Thank you.
2 MR. BAYLY: I know I filed a response.
3 JUDGE BITTNER: Yes. I was looking at the
4 August 12 ruling, which doesn't apply to this.
5 But, you know, I'm going to paper clip it.
6 MS. CARPENTER: Your Honor, I don't know
7 that we included this one.
8 JUDGE BITTNER: Okay.
9 MR. BAYLY: That's your order.
10 JUDGE BITTNER: Yes, it is.
11 MS. CARPENTER: That was Exhibit 41, and I
12 think Your Honor--right, and that's the one that
13 Your Honor limited, I believe, in your order.
14 JUDGE BITTNER: That's what I'm trying to
15 find.
16 MS. CARPENTER: Okay.
17 MR. BAYLY: I found it.
18 JUDGE BITTNER: Okay. What's the date,
19 since mine are filed by--
20 MR. BAYLY: November 8, 2005. It's
21 entitled--it should be a Memorandum of Accounts and
22 Ruling on Motion to Exclude Evidence. Yes, that's
1882
1 it.
2 JUDGE BITTNER: Okay.
3 MS. CARPENTER: Page five of that order.
4 MR. BAYLY: Okay. So 41 was on the table--
5 JUDGE BITTNER: I'm sorry, what was the
6 date of it?
7 MR. BAYLY: November 8, 2005.
8 JUDGE BITTNER: Aha. Okay.
9 MS. CARPENTER: Page five, at the very
10 bottom.
11 JUDGE BITTNER: Okay. So what I said was
12 just that I would limit--I may as well quote
13 myself. Suppose Government Exhibit 41 discusses
14 both the risks of smoking marijuana and the extent
15 of use. I shall not exclude the article, but to
16 the extent it discusses risks, I conclude that it
17 pertains to whether marijuana has the potential for
18 use as medicine and shall not consider it. So I
19 will adhere to that.
20 I think that there is kind of a fine line
21 between risks and diversion, and I also don't think
1883
1 that I'm in a position to draw that line now. I am
2 aware of it, and I know you will all brief it and I
3 know you will all tell me that I should consider
4 certain things and not consider other things
5 because of that line, wherever it may be.
6 MS. CARPENTER: Okay.
7 JUDGE BITTNER: So with that, I'll
8 overrule the objection to 40 and 41 with this
9 caveat. So 40 and 41 are received, finally.
10 [Government's Exhibits Nos. 40
11 and 41 were received into
12 evidence.]
13 MS. CARPENTER: Your Honor, I just have
14 one follow-up question to that. Then the risks--we
15 just want to understand for purposes so we're not
16 jumping up and down and objecting continuously.
17 But by diversion, Your Honor means the risk that
18 something will go out into the illicit market from
19 the manufacturing market, is that correct?
20 JUDGE BITTNER: No.
21 MS. CARPENTER: No?
22 JUDGE BITTNER: I think, and I may--since
1884
1 I wasn't expecting this question, I may modify it,
2 but I think of diversion somewhat more broadly,
3 that a substance will be used for other than a
4 legitimate use, okay?
5 MS. CARPENTER: Okay.
6 JUDGE BITTNER: In other words, off the
7 top of my head, I would say that a consumer, for
8 example, an individual consumer who is prescribed a
9 narcotic for pain relief and who then continues to
10 use that drug after the pain is gone is diverting.
11 MS. CARPENTER: Okay.
12 JUDGE BITTNER: Okay?
13 MS. CARPENTER: And that's the sort of
14 diversion you're considering relevant for this
15 hearing, where you talk about a manufacturer of
16 something that's not--
17 JUDGE BITTNER: Well, you asked broadly
18 about what diversion is--
19 MS. CARPENTER: Right.
20 JUDGE BITTNER: --and I think my
21 definition of diversion--and there may be another
22 one someplace that I should be applying, I'd have
1885
1 to look--is the use of any controlled substance for
2 other than a legitimate use. Note that I didn't
3 say legitimate medical use.
4 MS. CARPENTER: Okay. But it's the risk
5 of that happening and not the risk of--and not the
6 harm caused by that, because that's the reason it's
7 in the controlled substance in the first place.
8 I'm just trying to understand whether that includes
9 harm caused by that substance, which I think you've
10 excluded by your--
11 JUDGE BITTNER: If it's harm caused by--there's
12 risk and risk, I guess, and Dr. Voth knows
13 a lot more about this than I do--at least I hope
14 you do--that there's the harm that comes from--that
15 could come--potential for harm from using anything,
16 right? I mean, you take too much pain killer for
17 pain, you can have side effects and you could have
18 other issues. And then there's harm associated
19 with the non-legitimate use and what I'm trying to
20 do is draw that line, but I haven't gotten there
21 yet.
22 MS. CARPENTER: Then we'll just try and
1886
1 draw it as we go.
2 JUDGE BITTNER: Yes. Now that I've
3 totally confused the issue, would you like to go
4 on, Mr. Bayly?
5 MR. BAYLY: At the risk of--
6 JUDGE BITTNER: Oh oh--
7 MR. BAYLY: --muddying up the waters, I
8 just want to put in a response to Ms. Carpenter's
9 concerns. And I think I should put this on the
10 record because we're going to get into this on our
11 brief, and I think, Judge, you should know, and
12 Respondent should know, too, where we're coming
13 from, and that is the problem is that somebody that
14 uses a drug legitimately, whether it's prescribed
15 by a physician or whether it's in a proper IND
16 study or any other legal circumstances, those drugs
17 have some kind of an effect. Of course, if the
18 persons use them outside of these legitimate
19 avenues, the drugs still have an effect. It's just
20 that the effects can be even worse if they're not
21 controlled by a limited or a lawful-type setting.
22 But the problem is, and this is why I think the
1887
1 effects of marijuana or really any controlled
2 substance would be relevant because the effects are
3 going to occur in a diversion-type setting.
4 So, in other words, if an article talks
5 about toxic effects, say, of any drug, those toxic
6 effects may occur in a diversion context. They may
7 occur even in a legitimate medical setting where a
8 doctor has got some pretty weighty issues and has
9 got to weigh it on kind of a cost-benefit analysis.
10 So that's, I think, why we contend that maybe some
11 of these articles were relevant whereas maybe Your
12 Honor perhaps excluded them or Respondents argue
13 that, well, the effects should not be considered
14 because they're effects in a clinical or legitimate
15 context. For whatever that's worse, I just want to
16 get that on the record.
17 JUDGE BITTNER: That's the line I'm going
18 to have to draw.
19 MS. CARPENTER: Right.
20 JUDGE BITTNER: But I'm not drawing it
21 now.
22 MS. CARPENTER: I understand. Thank you.
1888
1 JUDGE BITTNER: Okay.
2 MS. CARPENTER: The statute 823(a), you
3 know, it's in the context of manufacturing and it
4 says the DEA shall consider maintenance of
5 effective controls--this is the context of a
6 particular license--maintenance of effective
7 controls against diversion of particular controlled
8 substance, you know, the ones for which the license
9 will be granted. So I think it's getting very far
10 afield to say the fact that at one point, FDA may
11 make this into medicine and it may be usable and
12 somebody may misuse it, that's really an issue for
13 the FDA to decide at the point where they're
14 deciding whether or not it's going to be permitted
15 to be used as medicine. One of the things they'll
16 consider is what the risks are.
17 So I think looking that far down the road
18 and talking about the risks of that sort of use,
19 anybody else using it, and not looking at the risks
20 of diversion from the granting of this license, it
21 goes way beyond what the statute allows the DEA--
22 JUDGE BITTNER: Right, but there is also
1889
1 the other--the catch-all phrase, and--
2 MS. CARPENTER: But--
3 JUDGE BITTNER: --I think, also, there is
4 the issue that the same harm, whatever that might
5 be, that might be incident to legitimate use could
6 also be a reason for illegitimate use. That's
7 where the line gets fuzzy.
8 MS. CARPENTER: Okay.
9 JUDGE BITTNER: I don't think I want to go
10 beyond that. So we're just going to have to leave
11 it where it is and I'll do the best I can. Okay.
12 MR. BAYLY: I think all these will be
13 briefed, so--
14 JUDGE BITTNER: I think the briefs will be
15 fascinating.
16 MR. BAYLY: The brief will be, I am sure,
17 a misnomer, but if I may continue, Your Honor,
18 questioning.
19 JUDGE BITTNER: Yes, please.
20 MR. BAYLY: Thank you.
21 BY MR. BAYLY:
22 Q Dr. Voth, based upon your experience and
1890
1 education, have you studied and learned about
2 marijuana and its constituents?
3 A Yes, I have.
4 Q And based upon your experience and
5 education, have you studied and learned about the
6 physiological and psychological effects that
7 marijuana and its constituents has on a human?
8 A Yes, I have.
9 Q Have you testified in court as an expert
10 about marijuana before?
11 A Yes, I've testified not only in Federal
12 court, but some State courts, as well.
13 Q Roughly how many times have you testified
14 as an expert on marijuana?
15 A Maybe three or four or five, along in--three to
16 five times.
17 MR. BAYLY: All right. Your Honor, I now
18 want to move Government Exhibit 36 into evidence.
19 That's Dr. Voth's CV.
20 JUDGE BITTNER: Mr. Jacobowitz?
21 MR. JACOBOWITZ: No objection, Your Honor.
22 JUDGE BITTNER: Okay. Government's 36 is
1891
1 received.
2 [Government's Exhibit No. 36
3 was received into evidence.]
4 MR. BAYLY: Based upon the CV and Dr.
5 Voth's testimony and the articles mentioned in the
6 CV and the two articles actually admitted, I'd like
7 to now request that the Court qualify Dr. Voth as a
8 medical expert in internal medicine and as an
9 expert in marijuana as it pertains to its effects,
10 abuse, and potential medical use on humans.
11 JUDGE BITTNER: Mr. Jacobowitz?
12 MR. JACOBOWITZ: Dr. Voth appears
13 qualified as an expert in these matters, but we
14 remain objecting that the potential effects on
15 humans of medical use of marijuana is not relevant
16 in this hearing. It's been excluded.
17 JUDGE BITTNER: Okay. We'll hope that I'm
18 consistent in my rulings. The question is whether
19 Dr. Voth is an expert, and I gather you don't
20 dispute that he is.
21 MR. JACOBOWITZ: I don't dispute that he's
22 an expert. I--
1892
1 JUDGE BITTNER: You just want to limit his
2 testimony, but not on the basis of his expertise
3 but on relevance?
4 MR. JACOBOWITZ: Yes.
5 JUDGE BITTNER: Okay. You're an expert,
6 Doctor. Thank you.
7 MR. JACOBOWITZ: I'm sorry. Just a
8 moment, Your Honor.
9 [Pause.]
10 MR. JACOBOWITZ: Actually, I'm not sure
11 we've heard his qualifications on the potential
12 medical use of marijuana.
13 JUDGE BITTNER: Would you like to voir
14 dire him?
15 [Pause.]
16 VOIR DIRE
17 BY MR. JACOBOWITZ:
18 Q Dr. Voth, have you yourself done any
19 research on the potential medical use of marijuana,
20 the plant marijuana?
21 A I have not performed actual plant
22 research, no.
1893
1 MR. BAYLY: Your Honor, if I may cut this
2 short, we tendered him as an expert on medical use.
3 We also tendered Dr. Voth as an expert on
4 marijuana's effects and abuse on humans. So let me
5 cut down the proffer here and offer Dr. Voth as an
6 expert in marijuana as it pertains to its effects,
7 abuse, and constituents on humans--well, effects,
8 abuse on humans, and its constituents. We won't
9 get into the medical use issue.
10 JUDGE BITTNER: Okay.
11 MR. JACOBOWITZ: No, Judge.
12 JUDGE BITTNER: Okay. Then you're still
13 an expert, Dr. Voth.
14 BY MR. BAYLY:
15 Q Dr. Voth, could you generally tell us,
16 what is a constituent?
17 A Well, in all drugs, whether they be plant
18 or otherwise, there are substances that constitute
19 the drug, and in marijuana's case, there are a
20 number of substances that have been identified in
21 the plant marijuana.
22 Q And can you generally tell us what
1894
1 substances have been identified in the plant
2 marijuana?
3 A There are approximately 480-plus
4 substances. About 66 of those are cannabinoids, so
5 when I use the term "cannabinoids," I just want to
6 be clear that that means the substances that
7 resemble the major active ingredient Delta 9 THC,
8 or Delta 9 tetrahydrocannabinol. So in other
9 words, 66 cannabinoid-related substances and then
10 400-plus other substances that have been
11 identified.
12 Q All right. Why segregate the cannabinoids
13 from the 488 other substances identified?
14 A Well, primarily because they're
15 structurally related. They're very similar in
16 structure, but they're not identical.
17 Q You're talking about the cannabinoids?
18 A Cannabinoids, correct. The others, there
19 are groupings, but not the same in the
20 cannabinoids. They don't resemble the
21 cannabinoids. They're other things like tars and
22 that kind of thing.
1895
1 JUDGE BITTNER: Do cannabinoids appear in
2 any other plant product--in any other plant, I
3 should say?
4 THE WITNESS: That's an interesting
5 question. I don't know the answer to that.
6 JUDGE BITTNER: Okay.
7 THE WITNESS: Interesting question,
8 though.
9 JUDGE BITTNER: I only get to ask one or
10 two a hearing.
11 THE WITNESS: It would seem reasonable
12 that they would. Off the top of my head, I can't
13 think, though, of others that they would exist in.
14 JUDGE BITTNER: Okay.
15 THE WITNESS: Naturally occurring, anyway.
16 JUDGE BITTNER: Right. Okay.
17 BY MR. BAYLY:
18 Q Dr. Voth, when you're talking about the
19 cannabinoids, the 66 cannabinoids, are you talking
20 about some of them being active as opposed to
21 inactive ingredients, or how would you characterize
22 that?
1896
1 A Well, that's an interesting point, because
2 really, they've not all been studied in detail as
3 far as their activity. I mean, there's a sense
4 that there are certain ones that are more active
5 than others. Certainly Delta 9 THC, Delta 8 THC,
6 cannabidiol. The drug Sativex, for instance, works
7 with Delta 9 THC and cannabidiol. So there has
8 been some look at those. But to the best of my
9 knowledge, there's no one that said that one
10 through 66, certain ones absolutely are active and
11 certain absolutely aren't active. I think they
12 probably all have relative degrees of activity, is
13 the best way to put that.
14 Q But it's relative, then?
15 A Relative, yes.
16 Q How about the 488 other constituents? How
17 would you describe those in terms of active versus
18 inactive?
19 A Just to be clear, there would be
20 approximately 420, not that it makes any
21 difference, but just to be clear. That's again
22 another interesting question, because I'm unaware
1897
1 that anyone has looked in detail at every one of
2 those. Many of them are the kind of things like
3 turpines and tars and et cetera that one has to be
4 concerned about activity, but I don't think that's
5 been well defined. Certainly, there's a lot of
6 similarity between tobacco smoke and marijuana
7 smoke. We know that tobacco smoke is very active.
8 So I guess that's a larger area of concern, what
9 happens in that mix of 400-plus other substances
10 that's sucked into people's lungs. Don't know.
11 Q But do some of these 420 other substances,
12 then, do you say they have some parallel active
13 activities similar to tobacco?
14 A Well, it's probable that there are
15 physiologic effects from them. Whether any of them
16 have any kind of intoxicating effects or mood
17 altering effects is less likely, but certainly
18 physiologic effects.
19 Q Now, you've already mentioned, I think,
20 one of the cannabinoid constituents. I think you
21 characterize it as one of the main ones, as Delta 9
22 THC. Do you recall that testimony?
1898
1 A Yes.
2 Q All right. Can you tell us what the
3 effect of the--I'm just going to call it THC for
4 shorthand purposes, but what is the effect of THC
5 on a person in the short term?
6 A In the midst of that cough, did you say in
7 the short term?
8 Q Yes.
9 A So the acute effects, more or less, just
10 to be clear?
11 Q Yes.
12 A To the best of what I'm aware of, the
13 primary effect is a sense of intoxication, a sense
14 of feeling stoned. So to some extent, a change in
15 mood and those behaviors that go along with
16 intoxication, such as coordination, concentration,
17 short-term memory involvement, driving skill
18 abilities. Interestingly, dysphoria, panic
19 attacks, psychotic episodes can occur with that.
20 Some sedation. So in terms of--I guess those are
21 the effects that would most typically be associated
22 with some acute use.
1899
1 Q Could you tell us some of the effects on
2 humans of THC in the long term? I guess I'd
3 characterize that as chronic use?
4 A Yes. With chronic use--well, one of the
5 big areas of concern is habituation or dependence,
6 and some refer to this as addiction, certainly
7 worsening of memory disorders, concentration
8 ability, short-term memory, increasing risk of
9 psychotic and other psychiatric disorders, for that
10 matter. And depending on age groups particular,
11 but especially in young people, productivity,
12 school performance, cognitive abilities, those kind
13 of things.
14 Q Dr. Voth, can a person suffer--is a
15 possible for a person to suffer an acute lethal
16 dose from ingesting too much THC from marijuana?
17 A No, it's not, because THC doesn't really
18 affect the brain stem and drugs that cause
19 overdoses that way, like alcohol and some of the
20 sedatives, will suppress the activity in the brain
21 stem and stop people's breathing, but marijuana
22 does not affect that part of the brain.
1900
1 Q But what are some of the effects of a
2 person ingesting higher levels of THC from
3 marijuana just at one time, for example, compare
4 somebody who smokes a marijuana cigarette with just
5 four percent THC potency as opposed to a marijuana
6 cigarette that has THC potency of 15 percent.
7 A So you're talking about a roughly three-time--a
8 factor of three intensity. Well, certainly
9 the high, the intoxication potential, is greater.
10 I would say the risk of dysphoria is certainly
11 greater. Panic attack, certainly greater.
12 Clearly, coordination, driving skills. One effect
13 that I had failed to mention earlier is the effect
14 on heart rate, heart rate being increased. I can't
15 honestly say that I'd be aware of studies that
16 looked specifically at changes in heart rate
17 relative to concentration. Theoretically, perhaps.
18 But I think that would pretty well encapsulate it.
19 Essentially, any effect at a low dose is enhanced
20 at a three times or three-fold factor higher dose.
21 Q Dr. Voth, what would one potential--let me
22 rephrase the question here. Would one potential
1901
1 benefit of marijuana be that if one smokes a higher
2 level of THC, then wouldn't that person need to
3 smoke less of the carcinogen constituents in
4 marijuana in order to get, quote, "high"?
5 MR. JACOBOWITZ: Objection, Your Honor.
6 JUDGE BITTNER: Grounds?
7 MR. JACOBOWITZ: This goes directly, I
8 think, to the medical effects. We are speaking now
9 of the carcinogenic effects. This goes directly to
10 side effects as a medical use.
11 JUDGE BITTNER: Overruled, but if I decide
12 I was wrong, I won't consider it.
13 MR. BAYLY: For the record, I'm talking
14 about and I asked specifically about abuse, so
15 that's the--
16 JUDGE BITTNER: Okay.
17 BY MR. BAYLY:
18 Q Do you want me to repeat the question?
19 A No, I think I understand it. The real
20 question would be--
21 MR. JACOBOWITZ: Objection to a lack of
22 foundation, also, I think, about carcinogenic
1902
1 effects.
2 JUDGE BITTNER: Would you rephrase the
3 question, Mr. Bayly?
4 BY MR. BAYLY:
5 Q We can back up here. In smoking
6 marijuana, are there carcinogenic effects from
7 that?
8 A Well, there are certainly carcinogens that
9 are inhaled. There is concern in the literature
10 about damage to the lungs and airways. There is
11 some conflict in the literature about whether there
12 is actually a causality for lung cancer, mouth
13 cancer, that kind of thing. So yes, carcinogens
14 are inhaled. What happens with those carcinogens
15 is hard to say for sure. There is certainly
16 irritation in the airways, certainly things like
17 bronchitis and airway changes and all of that.
18 Now, relative to carcinogens, one has to
19 consider what effect you're talking about. If it's
20 to become intoxicated, the literature has actually
21 looked at this and not found a consistent pattern
22 in the use of a higher drug--the use of a higher
1903
1 THC concentration and inhaling less, necessarily,
2 and that's only relative to intoxication.
3 Now, you're talking about a three times
4 higher concentration and I don't think that's been
5 studied nor looked at. But for lower
6 concentrations, the literature has been very
7 inconsistent in that regard. In other words,
8 whether a user would smoke less just because it's
9 stronger. A user may very well smoke more because
10 he's getting more stoned, or smoke differently. So
11 it's very inconsistent as to what's actually seen
12 in the literature. Relative to your specific
13 question of four percent versus, I think you said
14 15 percent, I don't know, and I don't think that's
15 been defined in the literature.
16 Q All right. But let me ask you just
17 generally, Dr. Voth. What is tolerance?
18 A Tolerance is more or less a biochemical
19 process and a brain process that the user develops
20 an ability to be exposed to a dose of any medicine,
21 narcotic or whatever, marijuana, to be exposed to
22 that at increasing levels without experiencing a
1904
1 side effect from it, particularly the intoxication
2 side effect. An example would be alcohol. A
3 person who drinks a significant amount can, quote,
4 "hold their alcohol" better than a person who
5 doesn't. The same way with narcotics. Marijuana
6 is very much the same.
7 Q Can this phenomena of tolerance, as you've
8 described it, occur with the THC in marijuana?
9 A Certainly it can, yes.
10 Q Do you, in your expertise, Dr. Voth, make
11 any distinctions between marijuana in its herbal
12 plant form and its constituents?
13 A I'm not sure I understand that question.
14 Q Okay. Is there a difference between the
15 plant marijuana and the isolated individual
16 constituents?
17 A Oh, absolutely, because the plant
18 marijuana, of course, has that milieu of 400-plus
19 substances, 66 cannabinoids, and the individual
20 constituents are just that, individual
21 constituents--Delta 9 THC, Delta 8 THC, et cetera.
22 Q Dr. Voth, in terms of the abuse of
1905
1 marijuana, what is the common form of marijuana
2 that is abused? Is it the plant material itself or
3 is it any of its constituents?
4 A Well, the most common abuse is with the
5 plant form. In fact, I have not been able to
6 determine any significant abuse listed out there
7 for Drabinol or Marinol, which would be the only
8 prescribable form of Delta 9 THC available on the
9 market, that I'm aware of--in the U.S., anyway.
10 Q Right now, let's turn to another subject.
11 Dr. Voth, are you familiar with a product called
12 Sativex? I'm going to spell that for the record
13 and the court reporter. That's S-a-t-i-v-e-x.
14 A Yes, I am familiar with it.
15 Q Okay. Can you tell us what your
16 understanding of what this product is, generally?
17 A To the best of my knowledge in regards to
18 Sativex, it's been a highly hybridized and worked
19 on product that has created a hybrid so that Delta
20 9 THC and cannabidiol are in pretty much a one-to-one ratio
21 rather than the very low ratios seen
22 typically in leaf marijuana as we know it.
1906
1 Q I just want to back up to get some other
2 information about it before we get into more
3 details on that subject, Dr. Voth, and ask you, are
4 you aware of who is the manufacturer of this
5 product?
6 A I believe G.W. Pharmaceuticals is the
7 manufacturer of it.
8 Q And are you aware of how this product is
9 administered?
10 A I believe they have an inhaler--well, the
11 substance is more or less extracted and refined and
12 then administered via a small inhaler.
13 Q Are you aware in what country or countries
14 that Sativex is marketed a lawful prescription
15 medicine?
16 A To the best of my knowledge, I think that
17 Canada is the only one where it's readily legally
18 available at this point.
19 Q Can you tell us what the difference is
20 between the crude plant marijuana and Sativex?
21 A Well, quite a few things, really. The
22 biggest one is that there is a difference between
1907
1 the THC and cannabidiol ratios. G.W., in their
2 research, has found that this one-to-one ratio of
3 Delta 9 THC to cannabidiol is more effective for
4 the things that they're using it or suggesting it
5 to be used for than the higher Delta 9 and very low
6 cannabidiol concentrations.
7 The other difference is that, well,
8 marijuana, of course, is marijuana. It's got all
9 of the other substances associated. What I am not
10 clear on is how much of that other mix of stuff,
11 we'll call it, the other 400-plus substances is
12 represented in Sativex when it's extracted, and I
13 don't--I haven't seen good data as to what all is
14 in that. So there is probably some difference
15 between that and leaf marijuana, but I can't recite
16 to you the differences exactly. I think that may
17 be one of the failings, unfortunately, of Sativex,
18 too, is that there's this sort of unknown stuff
19 that hasn't been clearly defined.
20 Q Well, when you say "stuff," are you
21 referring back to the cannabinoids or are you
22 referring back to the other 400-and-so
1908
1 constituents?
2 A All substances, because I have not seen a
3 clear definition of what other cannabinoids are
4 present, what their activities are, and what of the
5 other 400-plus substances exist and what their
6 activities are, and that's probably, if I were
7 guessing, why it's having difficulty in the U.K.--
8 MR. JACOBOWITZ: Objection.
9 JUDGE BITTNER: Sustained.
10 BY MR. BAYLY:
11 Q Are you familiar with a product called
12 Marinol?
13 A Yes, I am.
14 Q Have you ever used it in your practice,
15 Dr. Voth?
16 A I have occasionally, yes.
17 Q Do you know what it's made from?
18 A It's a synthetic form of Delta 9 THC
19 called Drabinol.
20 Q Any other constituents in it?
21 A There are inert constituents, but I
22 believe it's all Delta 9.
1909
1 Q Okay. And what is Marinol designed to do
2 in terms of treatment?
3 A Its primary indications are for appetite
4 enhancement and nausea, and there is some use now
5 for nursing home patients in agitated states and
6 also to stimulate appetite in cachexia or people
7 that are not eating well in nursing homes.
8 Q Is there a benefit medically of smoking
9 marijuana over the oral administration?
10 A I've certainly never seen any, I mean,
11 benefit-wise. The only potential benefit-wise
12 might be the rapidity in absorption. However, that
13 has some downside to it, too.
14 Q Dr. Voth, does smoking marijuana lead to
15 problems with the harshness on the throat and
16 lungs?
17 A Certainly, it does.
18 Q Would such problems be related to the
19 amount of THC or the potency of the THC in the
20 marijuana?
21 A Not necessarily. It's really just due to
22 the fact that it's a smoked substance, that there
1910
1 is a lot of irritant in that smoke.
2 Q Would such problems be related to the
3 amount of stems and seeds in the marijuana?
4 A I think there is old street rumor about
5 being down to seeds and stems again, but I've never
6 seen anything systematic that said that seeds and
7 stem constituents necessarily cause greater or less
8 irritation.
9 MR. BAYLY: Your Honor, I'd like to
10 request that the witness be handed--I think it's
11 Respondent's Exhibit 92A. That's the entitled,
12 "Guidance for Industry: Botanical Drug Products."
13 I want to make sure that's right for the record.
14 JUDGE BITTNER: I'm sorry, Government--did
15 you say Respondent--
16 MR. BAYLY: Is it Government?
17 JUDGE BITTNER: Well, it's not Respondent
18 92.
19 MS. CARPENTER: No.
20 MR. BAYLY: Okay, it's Government 92.
21 [The document was shown to the witness.]
22 BY MR. BAYLY:
1911
1 Q Dr. Voth, now that we've cleared that up,
2 you've got Government Exhibit 92A?
3 A Yes, I do.
4 Q Please turn to page 21.
5 A I'm at page 21.
6 Q I'd like you to go down toward the bottom
7 of the page, but you should see four bullets, four
8 paragraphs.
9 A Yes, I see them.
10 Q All right. Third from the bottom, it
11 starts out, "The quantitative description
12 (strength) of the drug substance." Can you read
13 that entire paragraph to yourself, please, and let
14 us know when you have looked at that paragraph.
15 [Pause.]
16 THE WITNESS: Okay, I've read it. Yes.
17 BY MR. BAYLY:
18 Q All right. And how would this paragraph
19 relate to marijuana as a botanical?
20 A Well, it would say that with the known
21 ingredients, in other words, we've got 400-plus
22 substances and we have a pretty good sense what
1912
1 they are and we know that they're measurable, the
2 amount--it says in this, the amount in which they
3 are present in the botanical should be declared,
4 and for a multi-herb substance, should be declared
5 in terms of relative ratio of the individually
6 processed botanical drug substances. So in other
7 words, relative to marijuana, Delta 9 THC and Delta
8 8, cannabidiol, blah, blah, blah, that should be
9 clearly delineated and, let's see, I think that's
10 pretty much all it would say. So, essentially,
11 you've got to know what's in your botanical and
12 what its ratios are.
13 Q In terms of the marijuana herbal or plant
14 material, is its chemistry, in your opinion, known
15 and reproducible?
16 A Well, I think the chemistry is known, but
17 it's reproducible is a very, very difficult
18 question. I don't think that the chemistry in
19 marijuana is easily reproducible. Again, you've
20 got 488 substances that have to be clearly
21 reproduced and defined in a predictable manner to
22 fulfill these criteria. So yes, the chemistry is
1913
1 defined, but reproducible, it is not.
2 Q I'd like you to turn to page 22--
3 A Okay.
4 Q --of this Government Exhibit 92 here, the
5 botanical guidelines.
6 A I'm there.
7 Q Please look at the three paragraphs under
8 "Appearance." It's about in the middle of the
9 page. Do you see where I'm talking about?
10 A Yes, I do.
11 Q If you would look at paragraph one, it
12 starts, "Chemical identification by spectroscopic
13 and/or chromatographic fingerprints," and just read
14 that paragraph to yourself, please, and let us know
15 when you have completed reading that.
16 A I want to be sure which one you want me to
17 read. Everything under "Appearance"?
18 Q Just the first paragraph. It ends, "two-
19 dimensional--TLC and gas chromatography."
20 A Okay.
21 [Pause.]
22 THE WITNESS: Okay. I've--
1914
1 BY MR. BAYLY:
2 Q All right. Can you tell us how marijuana
3 relates to this paragraph?
4 A Well, essentially, it would say that a
5 marijuana specimen would need to undergo these
6 chemical identification processes to see exactly
7 what's in it, exactly the constituents and they
8 need to be characterized and defined, in other
9 words.
10 Q Now, I'd like you to look at the second
11 paragraph. It starts, "Chemical assay--"
12 A Right.
13 Q --and it ends, "amounts should be
14 defined." Do you see that paragraph?
15 A Yes.
16 Q If you'd please read that and then just
17 let us know when you've completed reading that.
18 A Sure. I've read it.
19 Q How does plant marijuana relate to this
20 paragraph?
21 A Well, again, per their last comment, when
22 multiple active constituents or markers are known,
1915
1 they should be chemically characterized and their
2 relative amounts should be defined. So with
3 marijuana, 400-plus substances, those need to be
4 defined, marked, characterized, and the amount of
5 them need to be present, and especially in light of
6 the fact that from growth to growth, grower to
7 grower, those are going to change, that could be a
8 fairly--that's quite a process. Just a
9 parenthetical comment, but it's 400-plus
10 substances.
11 Q And then, Dr. Voth, I want to refer you to
12 the last paragraph. It starts, "Biological assay,"
13 and ends with, "should be performed." Please read
14 that and then let us know when you've done.
15 A Yes, I have.
16 Q And how does marijuana in its plant form
17 relate to this paragraph?
18 A Well, it particularly relates to the
19 second sentence, which says if the botanical drug
20 substance is considered potent, toxic, addictive,
21 or has abuse potential, an assay for biological
22 activity and/or a chemical assay for the active
1916
1 constituents should be performed. So at least the
2 cannabinoids in that regard.
3 Q Now, Dr. Voth, I want to ask you to please
4 turn to page 24 of Government Exhibit 92A,
5 Botanical Guidelines.
6 A Yes, I'm there.
7 Q Again, we're down toward the middle of the
8 page under, you see "Appearance," and then it's
9 three paragraphs down. Let me identify that for
10 you. The paragraph starts, "Biological assay (when
11 the active chemical constituents are not known or
12 quantifiable)." How does the plant marijuana
13 relate to this one phrase, whether the active
14 chemical constituents are not known or
15 quantifiable?
16 A Well, that's very similar to that last one
17 that we reviewed. In other words, when there's a
18 segment of the chemistry that we really don't know
19 necessarily what they are, but yet the drug itself
20 is potent, addictive, abuse potential, then there
21 needs to be biological activity and chemical assay
22 for the active constituents. So certainly that
1917
1 relates to marijuana. It's toxic, addictive, and
2 has abuse potential, so therefore there needs to be
3 biological activity and chemical assay for those
4 active constituents.
5 MR. BAYLY: That's all for now.
6 JUDGE BITTNER: Dr. Voth, if you know, can
7 something be addictive and not have abuse
8 potential?
9 THE WITNESS: Well, by definition, really,
10 if you're talking about addictive, dependence
11 formation, virtually every substance that I can
12 possibly think of that would have dependence
13 potential would also have abuse potential, and that
14 would cross into narcotics and virtually any other
15 drug I could possibly think of.
16 JUDGE BITTNER: But something could have
17 abuse potential but not be addictive?
18 THE WITNESS: I'd say they go very hand-in-glove.
19 Now, whether a person--no, I think
20 they're very hand-in-glove. I think a person can
21 abuse a drug and not necessarily become dependent
22 upon it, but having become dependent upon it,
1918
1 certainly, that drug can be abused, also. If you
2 want me to go on, I mean, I could give you some
3 examples, because that's really a much broader
4 answer than it might seem.
5 JUDGE BITTNER: Yes, please.
6 THE WITNESS: Narcotics, for instance, may
7 not be abused at all, but they are very dependence
8 forming. However, they certainly can be abused and
9 that's a great area of misunderstanding in the pain
10 management world right now, is if a person takes a
11 certain high dose, are they taking it because their
12 body is physically dependent on needing that
13 medicine for its therapeutic effects, yet they are
14 not actually abusing the drug. So they are
15 somewhat hand-in-glove, but they are not
16 necessitating of each other.
17 JUDGE BITTNER: Okay. Mr. Bayly?
18 MR. BAYLY: I have no follow-up, Your
19 Honor, and I am done with direct.
20 JUDGE BITTNER: Oh, okay. I thought you
21 were just done with that one exhibit. I was all--okay. Mr.
22 Jacobowitz? Do you want a short break?
1919
1 MR. JACOBOWITZ: We would like a short
2 break, please.
3 JUDGE BITTNER: Ten minutes. Off the
4 record.
5 [Recess.]
6 JUDGE BITTNER: On the record.
7 MR. BAYLY: Judge Bittner, I just want to
8 make one quick scheduling announcement. I just got
9 cell phoned here. Fortunately, it was before we
10 were on the record, but right before. Dr.
11 Auslander's train should get him in here so that he
12 should be at DEA headquarters by 1:15.
13 JUDGE BITTNER: Okay. Mr. Jacobowitz?
14 MR. JACOBOWITZ: Thank you.
15 CROSS EXAMINATION
16 BY MR. JACOBOWITZ:
17 Q Dr. Voth, as regards reproducibility,
18 would you agree that the primary factors that
19 control the cannabinoid content of marijuana, of
20 marijuana plant, are genetics and environmental
21 influences?
22 A I think that's fairly stated, yes.
1920
1 Q Environmental influences would include
2 such things as light and heat and nutrition,
3 humidity?
4 A Correct, yes.
5 Q And, in fact, also potency can be
6 affected, as well, by the stage of growth, I
7 believe?
8 A Yes, that's correct.
9 Q And also by the specific plant part used,
10 that leaves from one part of a plant will be
11 consistently higher in THC and perhaps in other
12 cannabinoids than leaves from another part of the
13 plant?
14 A It is possible, yes.
15 Q Also, there are hundreds of different
16 strains of cannabinoids with different genetic
17 qualities--sorry, of marijuana, I mean to say?
18 A I believe that's correct, yes.
19 Q Now, you referred to, I believe, to
20 studies showing great variation in marijuana. Do
21 you know that those studies did control for each
22 one of those separate variables?
1921
1 A Well, I think my comment was really more
2 to your prior question along that line of the
3 different variant species, et cetera. I mean,
4 there's a broad spectrum of THC content and
5 certainly percentage content of the various
6 cannabinoids and things. So I don't know that any
7 specific studies that was looking at that was
8 necessarily controlling those variables. No,
9 specifically to your question. But I think my
10 point was really more to the issue of you can't
11 just say, quote, "marijuana." I mean, you're
12 really referring to a very broad representation of
13 plants.
14 Q Now, are you familiar with the term
15 "vegetative propagation"?
16 A Yes. I mean, I've heard it. I'm not sure
17 I can give you a definition of it, but go ahead.
18 Q Do you know of plant cuttings, growing a
19 plant from cuttings?
20 A Yes, I do.
21 Q Now, would you be satisfied to call
22 growing a plant from cutting vegetative
1922
1 propagation?
2 A I don't know that I have the botanical
3 expertise to say one way or the other, honestly. I
4 wouldn't necessarily comment one way or the other,
5 no.
6 Q Are you aware that a plant grown from a
7 cutting is genetically identical to the parent
8 plant?
9 A Well, it certainly makes sense, yes. It's
10 like a stem cell phenomenon, more or less.
11 Q So a grower could grow genetically
12 identical plants rather than genetically varying
13 plants if he grew from cuttings?
14 A Theoretically, I'd have to say that would
15 be correct, yes.
16 Q And are you aware of Dr. Craker's
17 application to--
18 MR. BAYLY: Objection; out of the scope.
19 MR. JACOBOWITZ: I think it's what the
20 entire hearing is about. I think all of his
21 comments are related to Dr. Craker's application.
22 JUDGE BITTNER: Right, but that's not the
1923
1 issue. Sustained.
2 BY MR. JACOBOWITZ:
3 Q Have you seen Dr. Craker's application?
4 MR. BAYLY: Same objection.
5 JUDGE BITTNER: Sustained.
6 BY MR. JACOBOWITZ:
7 Q Could a grower of marijuana grow his
8 plants in a greenhouse or a growth room or an
9 environmental chamber?
10 A In a theoretical sense, yes. That's
11 frequently how marijuana is grown, whether legally
12 or illegally.
13 Q In such an enclosure, environmental
14 factors could be tightly controlled?
15 A I believe that that's certainly viable,
16 yes.
17 Q Just a moment.
18 [Pause.]
19 BY MR. JACOBOWITZ:
20 Q In general, plants are not of a single
21 chemical compound, are they?
22 A Are we talking about botany in general, or
1924
1 marijuana--
2 Q Botany in general, if you know, plants--
3 A Well, most plants have many chemicals in
4 them, yes.
5 Q Possibly many hundreds of chemicals even?
6 A Certainly. I mean, that's what we see
7 with marijuana, of course. Right.
8 Q And turning your attention, if I may, to
9 Government's Exhibit 92A, which you discussed on
10 direct--
11 [The document was shown to the witness.]
12 BY MR. JACOBOWITZ:
13 Q Now, if you could look to page two, to the
14 second paragraph under the heading "Background"--
15 A It starts, "For the purposes of this
16 document," is that correct?
17 Q Mm-hmm.
18 A Okay.
19 Q And it continues, the term botanicals
20 includes plant materials.
21 A Yes.
22 Q And turning to page one, under
1925
1 "Introduction," that first paragraph, if you could
2 look at that.
3 A I'm on page one.
4 Q Page one indicates that this will provide
5 guidance for submitting what are called INDs,
6 Investigational New Drug applications, for, among
7 other things, botanicals.
8 A Yes.
9 Q And that is the term defined as including
10 plant material?
11 A That's correct.
12 Q So this guidance, then, would go to
13 submitting INDs for materials that include hundreds
14 of chemical compounds, possibly, or certainly more
15 than one or a couple?
16 A Well, first of all, I've only seen this
17 this morning. It's my--I'm assuming by botanical
18 compounds we're talking about plants, as we've
19 mentioned, and as we've also discussed, plants may
20 contain hundreds of compounds. So I think my
21 answer to your question is yes.
22 Q Now, if you could turn to page nine, at
1926
1 the first paragraph under the italicized list--
2 A It starts, "Section 312"?
3 Q Exactly. Now, do you see the sentence
4 that begins, "A sponsor need not differentiate the
5 clinical effects of each molecular entity--"
6 A Yes, I do.
7 Q "--in a botanical product"?
8 A Right.
9 Q And that sentence says that the sponsor
10 does not need to make clear which effects are
11 caused by exactly which of each separate molecular
12 entity in a botanical product for purposes of
13 submitting the IND, is that right?
14 A Specifically, it says a sponsor need not
15 differentiate the clinical effects of each
16 molecular entity in a botanical product derived
17 from a single part of a plant, okay.
18 Q And if you could also go on and tell me
19 what the next sentence indicates.
20 A Even where the components of a combination
21 product must be studied under the statute, initial
22 control studies could be used to evaluate the
1927
1 entire combination product.
2 Q By combination product, that would mean
3 the combination compounds of botanical material?
4 A I think that's a fair assumption.
5 Q Now, you read earlier, I believe, from
6 pages 21 and 22, and just to make clear, could we
7 look at page 19, the beginning of the section in
8 which those pages appear.
9 A Page 19, Section 8, is that correct?
10 Q Mm-hmm.
11 A Okay.
12 Q And this is the section for Phase I and
13 Phase II clinical studies for non-marketed
14 botanical products and products with known safety
15 concerns?
16 A That is correct, yes.
17 Q And as you discussed before, this section
18 specifically discusses marijuana as such a
19 compound?
20 A I don't believe it specifically named
21 marijuana.
22 Q If you could look at page 24, I believe we
1928
1 discussed this paragraph on direct.
2 A --marijuana, sure enough. Okay.
3 Q And at page 22, also a section you were
4 looking at on direct, I believe.
5 A Yes, I'm on page 22.
6 Q The fourth indented paragraph.
7 A That says "Chemical Assay"?
8 Q "Biological Assay."
9 A "Biological Assay," okay.
10 Q And that also specifically refers to
11 marijuana?
12 A It gives as an example marijuana, yes,
13 ephedra marijuana. Right.
14 Q Now, when you were discussing that
15 paragraph earlier--I may be confusing it actually
16 with the nearly identical paragraph on page 24, so
17 I hope this will apply to both of these very nearly
18 identical paragraphs--I believe you indicated that
19 the requirement may only apply to the cannabinoids?
20 A No, I don't think so. I think I was
21 giving the cannabinoids as an example. In other
22 words, one of the things that might be looked at
1929
1 would be a biological assay of what cannabinoids
2 and what their concentrations were, for instance,
3 and that was more of an example, I think, than my
4 interpretation of statute or of the statements.
5 Q Are there inactive--I'm sorry. Let me go
6 back. This paragraph and the one on page 24, the
7 ones you discussed from these two pages, discuss
8 active constituents?
9 A I believe they do. To the best of my
10 recollection, I believe they do. I'm not sure
11 where it's specifically stated, but nonetheless--
12 Q Well, let's take a look. On page 22, that
13 paragraph beginning, "Biological Assay," could you
14 look at just the last, say the last clause of the
15 last sentence, an assay for biological activity?
16 A For the active constituents, right.
17 Q And on the paragraph just before that,
18 could you read the first sentence of that
19 paragraph?
20 A "Chemical assay for active constituents
21 were characteristic markers," right.
22 Q Now, are there such things as inactive
1930
1 constituents of plants?
2 A Oh, certainly there are, mm-hmm.
3 Q Are there inactive constituents of the
4 marijuana plant?
5 A I would assume there are, and there are
6 different types of activities of the active
7 constituents. In other words, psychoactive,
8 physiologically active, inactive, et cetera. So
9 there are a whole host of those things.
10 Q So not every one of the 420 or 480
11 compounds in marijuana would have to be--would be
12 covered by these two paragraphs, which refer to
13 active constituents?
14 A That's a reasonable assumption. The
15 problem is, unfortunately, knowing which are active
16 and which are inactive, and that's kind of a
17 difficult question. I mean, there's psychoactive,
18 there's physiologically active, and then there's
19 inactive, and I don't think that's been well
20 defined. There's certainly a lot of substances
21 that need to be looked at and defined.
22 Q More research would be needed?
1931
1 A Yes.
2 Q And that's a determination that the FDA
3 would make under this guidance if an application
4 were submitted under this--
5 A I assume they would. I can't speak for
6 them, but I don't know. I would assume they would
7 make that determination.
8 MR. JACOBOWITZ: Now, could the witness be
9 given a copy of Respondent's Exhibit No. 54.
10 JUDGE BITTNER: Are you through with
11 Government 92A?
12 MR. JACOBOWITZ: I believe we are. Thank
13 you.
14 JUDGE BITTNER: And so you believe not?
15 MR. JACOBOWITZ: I believe we are.
16 JUDGE BITTNER: Just trying to figure out
17 what books I can close up.
18 BY MR. JACOBOWITZ:
19 Q Dr. Voth, let me ask you, I had the
20 impression from your testimony about
21 reproducibility that it is your understanding that
22 marijuana is not chemically reproducible. I
1932
1 believe you testified to that.
2 A If that's--well, I don't think that's
3 exactly what I said. I said reproducibility is a
4 difficult part, making a substance always
5 reproducible in the same percentages, the same
6 constituent states, et cetera, because there's a
7 lot of substances herbally and botanically to
8 reproduce.
9 Q But not impossible?
10 A It's not impossible, no.
11 Q And the FDA would be open to considering
12 whether marijuana is reproducible?
13 A Beats me.
14 MR. BAYLY: Objection, Your Honor. First
15 of all, there's a lack of foundation. Secondly,
16 Dr. Voth has already testified he can't speak for
17 them, and indeed, he can't. He is a private
18 doctor. So I definitely think he's not qualified
19 or should answer that question.
20 MR. JACOBOWITZ: I believe he's testified
21 as to what the FDA guidance suggests to him and
22 what it means.
1933
1 JUDGE BITTNER: Ask him if he knows, Mr.
2 Jacobowitz.
3 BY MR. JACOBOWITZ:
4 Q Do you know whether the FDA would consider
5 marijuana a reproducible substance for these
6 purposes?
7 A I have no idea. I have had no
8 communications with them, nor would I guess.
9 Q But you have no reason to believe that
10 they would not do so, would not consider it?
11 A I have no reason to believe either way. I
12 mean, I've seen nothing in either regard.
13 Q Are you familiar with the, what are called
14 Drug Master Files?
15 A Vaguely. I mean, I know that they exist,
16 but I really don't know a heck of a lot about them.
17 Q Are you aware that the Drug Master Files
18 are filed with the FDA as a part of applying for
19 Phase I or Phase II clinical trials?
20 A That wouldn't surprise me, no.
21 Q Are you aware that Dr. Elsohly of the
22 University of Mississippi has filed such a Drug
1934
1 Master File for marijuana with the FDA?
2 A I don't believe I was aware of that, no.
3 Q Are you aware that the FDA has approved
4 Phase II clinical trials for Dr. Elsohly based on,
5 among other things, this Drug Master File?
6 A I have no knowledge one way or the other
7 in that regard, no.
8 Q You are unaware of Dr. Elsohly's medical
9 trials with marijuana? I'm sorry, of any Phase II
10 clinical trials with marijuana?
11 A No. I think it was specific to Elsohly.
12 I'm unaware that he's filed and I'm unaware that
13 there's any such master file at the FDA for
14 marijuana. I'm not sure--I mean, I just am
15 unaware.
16 Q Going to Sativex, would it be correct to
17 say that you're skeptical of the concept of whole
18 plant use as a medication?
19 A Yes. I think that's a fair statement.
20 Q But it's--these are herbal remedies of the
21 sort we used before we progressed to modern
22 medicine.
1935
1 A Well, certainly not Sativex. Sativex is
2 probably a generation beyond that. I do think,
3 relative to marijuana, that that is sort of a
4 throwback to the days of herbal remedies and
5 witches' brews, yes.
6 Q Would that apply to other plant compounds,
7 as well, well, to other plant products, I guess I
8 should say?
9 A That's an awfully broad question. I mean,
10 there's a lot of things in medicine that have plant
11 origins that we use on a regular basis.
12 Q St. John's Wort, for example.
13 A St. John's Wort, sure.
14 Q That could be used as a medication?
15 A I'm aware that some people do that, yes.
16 Q It is prescribed in some countries as a
17 medication?
18 A I believe it is, yes.
19 Q And it is a whole plant product?
20 A That's correct.
21 Q Just a moment. I'm sorry.
22 [Pause.]
1936
1 BY MR. JACOBOWITZ:
2 Q Are you aware that the DEA recognizes that
3 the interaction among cannabinoids in marijuana may
4 be a critical factor in how marijuana affects the
5 body and the brain?
6 A I'm not sure that I have any opinions
7 about what the DEA is or isn't aware of. I--if
8 there's a specific thing you'd like me to comment
9 on, I'd be happy to do that.
10 Q I'm sorry. Just a moment, please.
11 [Pause.]
12 MR. JACOBOWITZ: Could the witness be
13 given Government Exhibit 25?
14 MR. BAYLY: I just want to confirm, Your
15 Honor, that for the record, I don't believe this
16 was admitted, is that correct?
17 MS. CARPENTER: That was one of the things
18 withdrawn yesterday.
19 MR. JACOBOWITZ: Oh--
20 JUDGE BITTNER: Let me look. Hold on.
21 MR. BAYLY: Yes, I believe that's--
22 MR. JACOBOWITZ: Then by all means, don't
1937
1 give the witness Government Exhibit 25.
2 JUDGE BITTNER: Let me just double-check,
3 since I, in theory, kept detailed notes of all of
4 these things. We're about to test that premise.
5 Yes, it was withdrawn on Wednesday.
6 BY MR. JACOBOWITZ:
7 Q Are you aware that researchers who wish to
8 use controlled substance in the research must apply
9 to the DEA for a registration number permitting
10 that?
11 A Yes, I'm aware of that fact.
12 Q And specifically if they wish to conduct
13 research on a Schedule I substance, they must
14 submit a written application with the protocol of
15 the study?
16 A Yes, I'm aware of that fact.
17 Q And is it correct that such an application
18 will describe exactly how much of the substance
19 they want and in what dosage they will apply it?
20 A I've not actually read the requirements
21 for that. I have a general sense that that is
22 correct, but I've never actually read any
1938
1 regulations in that regard.
2 Q Are you aware that the application must
3 also state for the DEA's consideration the security
4 precautions to be used in the study to guard
5 against diversion?
6 A Again, I have a general awareness of that
7 fact, but I have not specifically read it nor been
8 aware of regulations in that regard.
9 Q Are you aware that manufacturers, as well,
10 must submit an application to the DEA to
11 manufacture bulk drug products that are on Schedule
12 I?
13 A I believe that's correct, yes.
14 Q And manufacturers also must take security
15 precautions against diversion?
16 A To the best of my recollection and
17 knowledge, yes.
18 Q As an expert in drug abuse, do you think
19 that the DEA fulfills its duty in ensuring the
20 safety of controlled substances that are used in
21 such research programs?
22 MR. BAYLY: Objection. There's a scope, a
1939
1 foundation, and it's kind of unclear where the
2 question is going to.
3 JUDGE BITTNER: Sustained. I'm not sure
4 that being an expert in drug abuse necessarily
5 leads to knowledge of whether DEA controls
6 diversion in research, plus I think this goes
7 beyond the scope of direct.
8 MR. JACOBOWITZ: We may get to scope a
9 little more.
10 JUDGE BITTNER: Okay.
11 BY MR. JACOBOWITZ:
12 Q Are you aware of the University of
13 Mississippi's cannabis cultivation program?
14 A Yes, I am.
15 Q And that it cultivates and supplies
16 marijuana for research purposes?
17 A Yes, I am aware of that.
18 Q Are you aware that its cultivation site is
19 an outdoor site?
20 A Is a--
21 Q Is an outdoor site?
22 A Yes, I am aware of that.
1940
1 Q Are you aware that it employs temporary
2 workers, not permanent staff, sometimes for tenting
3 and harvesting?
4 MR. BAYLY: Objection. This is getting
5 out of the--definitely out of the scope of the
6 direct. I don't think the witness on direct ever
7 testified about Dr. Elsohly or any other cultivator
8 or manufacturer of marijuana.
9 MR. JACOBOWITZ: I wasn't going to go too
10 far more with this. I had one more question.
11 JUDGE BITTNER: I'll provisionally allow
12 it, but I might end up not considering it. I'll
13 change my ruling. Overruled, sort of.
14 THE WITNESS: I have no knowledge of that
15 element of how the Mississippi marijuana project is
16 run.
17 BY MR. JACOBOWITZ:
18 Q Are you aware of any incidents of
19 diversion from that program or the research from
20 that program?
21 MR. BAYLY: That, I would object.
22 JUDGE BITTNER: Sustained.
1941
1 BY MR. JACOBOWITZ:
2 Q Marijuana is a very commonly used illicit
3 drug in the United States, is it not?
4 A Yes, it is.
5 Q In fact, it's the most readily available
6 illicit drug in the United States?
7 A I think it's fair to say. Actually,
8 probably alcohol is among teenagers, but it would
9 be a very close second.
10 MR. JACOBOWITZ: Could the witness be
11 given Government Exhibit 45, please.
12 JUDGE BITTNER: That was Government
13 Exhibit 45?
14 MR. JACOBOWITZ: Yes.
15 [The document was shown to the witness.]
16 MR. BAYLY: Your Honor, I'd like to
17 confirm that it's been admitted. I think it has.
18 JUDGE BITTNER: It has.
19 MR. BAYLY: Yes. Okay.
20 THE WITNESS: I have it in front of me,
21 yes.
22 BY MR. JACOBOWITZ:
1942
1 Q Thank you. Could you, looking at the
2 first page, could you just identify this for the
3 record?
4 A This is the National Drug Intelligence
5 Center National Drug Threat Assessment 2005.
6 Q For what drug?
7 A For marijuana.
8 Q Thank you. If you would look at page six--
9 A I'm on page six.
10 Q On the second paragraph under the
11 "Availability" section.
12 A Okay.
13 Q The first sentence of that indicates that
14 at some DEA field offices and HIDTA offices,
15 marijuana is the most available illicit drug?
16 A I suspect that's accurate, but not being
17 looked at relative to alcohol, but I'll agree with
18 you. I think it's widely available.
19 JUDGE BITTNER: Do we know what DEA means
20 by the term "illicit drugs"? I'm asking anybody.
21 I don't know. I don't know if in preparing this
1943
1 document, DEA was considering controlled substances
2 only or if they were considering alcohol.
3 MS. CARPENTER: I don't think it includes
4 alcohol.
5 BY MR. JACOBOWITZ:
6 Q In fact, if the witness could look at page
7 31, at the final paragraph on that page, it's not--it speaks
8 somewhat to it.
9 A A specific area of this page, or what
10 would you--
11 Q At the final paragraph, please. I believe
12 there is a sort of comparison there--
13 JUDGE BITTNER: Oh, okay.
14 MR. JACOBOWITZ: --between marijuana and
15 illicit alcohol.
16 JUDGE BITTNER: Okay.
17 THE WITNESS: Well, but this says easier
18 to obtain, but if you look at things like National
19 Household Survey or Monitoring the Future, I think
20 you'll find as far as abuse, alcohol is about two-to-one
21 over marijuana. So I'm not going to split
22 hairs. I mean, it's a widely used, abused, and
1944
1 widely available drug.
2 BY MR. JACOBOWITZ:
3 Q Actually, could you read that sentence you
4 were just paraphrasing from?
5 A "Among established users, particularly
6 among older teens and young adults--"
7 Q I'm sorry, I believe it's the sentence
8 before that.
9 A Oh. "Indeed, reporting from some areas
10 has suggested that marijuana is easier for youths
11 to obtain than alcohol or cigarettes."
12 Q I'm sorry, one moment, please.
13 [Pause.]
14 MR. JACOBOWITZ: Could the witness be
15 given Government Exhibit 43, please.
16 [The document was shown to the witness.]
17 THE WITNESS: And I have in front of me
18 43, which is "Office of Rare Diseases Reports."
19 BY MR. JACOBOWITZ:
20 Q Who is that?
21 A "Office of Rare Diseases Reports, Report
22 on Rare Diseases Research Activities."
1945
1 Q And who is the issuer of that report?
2 A National Institute on Drug Abuse.
3 Q And if you would turn to page nine of that
4 report, which I believe has been admitted--rather,
5 a part of page nine has been admitted--looking at
6 the Section 4, the first paragraph.
7 A Okay.
8 Q Could you tell me what the estimate of
9 marijuana use made there is?
10 A That 14.6 million users in the past month
11 and particularly heavy use occurring in adolescent
12 populations, over 20 percent of all high school
13 seniors.
14 Q Mm-hmm.
15 A Is that the sentence you were after?
16 Q And the sentence after that?
17 A "Approximately 2.4 million people use
18 marijuana for the first time every year. Two-thirds of them
19 are between 12 and 17 years of age."
20 Q And turning back to Exhibit 45--
21 A I think I gave it back to her.
22 Q Oh, okay. I'm sorry. I didn't mean to
1946
1 make you go back and forth.
2 [The document was shown to the witness.]
3 THE WITNESS: That's kind of an
4 interesting paragraph right underneath that, too,
5 but I guess you didn't ask me to read that one, so--
6 BY MR. JACOBOWITZ:
7 Q No thank you. Putting this aside for the
8 moment, would you have an estimate of the number--of the
9 tonnage of marijuana made available in the
10 United States over an average year?
11 A Oh, gosh, I--
12 MR. BAYLY: Objection. This gets out of
13 the scope, too. I don't think we got into the
14 numbers.
15 JUDGE BITTNER: Sustained.
16 MR. JACOBOWITZ: I'm sorry. Excuse me for
17 a moment.
18 [Pause.]
19 BY MR. JACOBOWITZ:
20 Q One other question about diversion. You
21 testified, I believe, that one concern with respect
1947
1 to diversion is dependency and habituation.
2 A I'm not sure what the context exactly was,
3 but that would be a reasonable concern, that people
4 who would divert it would abuse it or become
5 dependent or sell it or involve people who had
6 become dependent on it, yes.
7 Q Now, isn't it true that marijuana has been
8 found in studies to cause dependency in only 0.5
9 percent of people who begin use after the age of
10 21?
11 A That wouldn't surprise me, because after
12 the age of 21, the instance of use drops quite a
13 lot. But in earlier ages, 14, 15, whatever,
14 incidence of dependence is extremely high.
15 Q Would that be as high as five percent?
16 A I think that's certainly compatible,
17 certai