Council for Tobacco Research
Deposition of Carol J. Henry, Ph.D. [Deposition of Henry in the Matter of State of Florida]
Fields
- Master ID
- Ctrmn00041767-1901
- Author
- Aw Roberts, J.R. Assoc
- Henry, C.J.
- Depository Date
- 08 Sep 1997
- Box
- 267
- Type
- TRANSCRIPT
- UCSF Legacy ID
- kmt30a00
Document Images
state oi rloriaa v.
a,m,xican Tobacco Company, et aL
(,l A: Ycs.
Izl Q: Was he a credible scientist?
[al A: Yes.
[cl Q: Was he a man of integrity?
(S1
lel
A: Yes.
Q: Did there come a time when
M Dr. Kreisher -
(al A: I'm sorry.You'rc talking about
(91 Dr. Kouri or Dr. Kreisher?
(,01 0: Dr. Kreisher.
(+,) A: I heard Dr. Kouri. I'm sorry.
hz; Q: Let me start over.
(,31 A: Both of them.
[,al 0: Both of them were men of integrity?
1151 A: As far as I know, yes, and I have
[+sl known them for many years.
(,7) 0: The agreement between the Council for
[+al Tobacco Research and Micro was in the form of a
(+el contract or a grant?
[20l A: It was in the form of a contract.
a+l 0: As a scientist, to your own knovvlcdge,
tnl is there a difference between a funding agency who
[231 issues a contract and a funding agency which
(zal issues a grant?
[2sl A: There can be.There does not have to
t+l be, but there can be.And as it turned out,
hl during the time of this contract, which had been,
pl as I mentioned, ongoing btforc I arrived, there
[l were then discussions about the vehicle by which
(s] the Council had work and research done at Micro,
161 and that a contract implied certain liability for
m the sponsor, meaning certain liability for the
ta; Council in performing the research and the kinds
191 of results we might find.
(10l A grant is - does not - apparently,
t++l and I'm no authority on this, but a grant is -
[+21 apparently has more flexibility in that the
[+31 sponsoring agency is not necessarily responsible
[,<l for the results.
(,s; )X'hether this was true or not or this
(+sl distinction is important or not, it seemed to be
[,r, important to the Council at the time, so that the
[+a; concerns about having a large contract where we
(+el were investigating a wide variety of elements and
[20; issues in carcinogenesis and its relationship
(2+; to - and cigarette smoke in relationship to
[2zl carcinogenesis became of great concern, at least
[231 that's what ne were told, and that eventually the
[2<l contract was then phased down, and we were told
(251 that the Council did not choose to have any
A. Wm. Roberts, Jr. & Assoc.
Page 29
Page 30
Carol J. Henry, Ph.D.
JulS' 31, 1997
l+l further contracts.
m They wanted to have all of their work
tal done under grants.
(al MR. MERRITT: Let me just interrupt
(s7 you for a second. In the spirit of our
(sl stipulation I just want to reiterate that the
m objections that are preserved are also the right
(el to move to strike for nonresponsiveness.
(sl MR. MOTLEY: Sure.
(,ol MR. MERRITT: And any objection based
t++l on the statement of expert testimony beyond the
(1z( witness's competence, that sort of thing.
hsl MR. MOTLEY: Yes, of course.
(+l MR. MERRITT: I'm sorry.
(is] BY MR. MOTLEY:
(+s; 0: When you say "we were told," "we"
(+7) including you?
(1el A: Ycs.
(1sl 0: And told by whom?
(2cl A: In our interactions with staff from
R+l the Council as well as their attorneys.
(zzl 0: Were attorneys involved on a regular
[zsl basis with the scientific research that was being
1Rl done by Micro?
j(i.1 A: My recollection about this is that the
(+l attorneys - the attorneys' involvement changed
m during the time of my association. I don't recall
hl knowing very much about the attorneys for the
[tl Council, although I think they were always
(si present.
Isl But as things progressed and after
m Dr. Kreisher's departure, the presence and
(al interaction with attorneys increased dramatically.
I[sl 0: Now, did there come a time when
~[,o[ Dr. Krcisher was dismissed by the Council for
t++l Tobacco Research?
I[+21 A: Yes. He was abruptly terminated.
(+31 There was no notice to Micro, and Dr.William
h+c Gardner then became our principal point of
i[+s; contact.
(161 0: And that was approximately 1978?
~(+-il A: I would have to check the times.
ina; 0: You have an affidavit that you've
i(+gl entered.You can refer to that to refresh your
czo; recollection.
Ri; A: Yes.As I was able to try and
;rzz; recollect the timing, it was approximately 1978.
~tr31 (Henry Deposition Exhibit Number 2 was
r.l marked for identification.)
IRs, 0: Dr. Henry, I'm handing you a document
Page 31
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~' ~~R ~'°'~~'~ 04' 1';~`"~ ~."

Carol J. Henry, Ph.D.
July 31, 1997
(+l produced by Philip Morris dated November 29th,
m 197-i, from a Dr. Osdene to Dr. Seligman, who I ask
(al you to assume were senior scientists with Philip
µi Morris, about the Council forTobacco Research.
tsl And I ask you to take a moment and look at that,
csi please.
m (Witness complies.)
(s( A: It's a little difficult to read, but I
m have read it.
hol Q: Dr. Henry, have you seen that document
(l prior to right now?
1121 A: Never.
pi 0: And does this document reference
1141 Dr. Kreisher?
oui A: Yes.
(+s( 0: In particular, in the paragraph that
t+71 begins, "Dr. Kreisher's work in the area of AHH
(iel from my point of view" - again, this is a Philip
1191 Morris internal document - "starts out with the
w proposition that smoking causes lung cancer.The
(z,l rest of the work seems to justify this approach."
(22; Now, first of all, what is AHHP
rn( A: It is the abbreviation for an enzyme
Iz.l system called aryl - it's actually - I believe
rzsi it's an incorrect abbreviation for aryl
t+l hydrocarbon hydroxylase, the enzyme system that
t4 Dr. Kouri had identified with his colleagues as
p( being one that can activate chemicals and actually
(41 activate or detoxify chemicals.
(sl 0: And was that part of what you,
161 Dr. Kouri and Dr. Kreisher were studying?
m A: Yes.
tei 0: And from your reading of this
191 paragraph, does this reference the work that you
(+ot were involved in?
[I A: It would appear to refer to the work
t+z( that the Council forTobacco Research was doing,
1131 and that with the aryl hydrocarbon hydroxylase
1141 work as well as - and its relationship to what we
(,s( were doing, it would seem to, although it does not
pq mention Micro.
n71 Q: Infactwasthatthctypcofworkyou
(,e) were involved in?
(+s1 A: Yes.
1201 Q0: The last paragraph reads as follows:
[z+( "It is my strong feeling that with the progress
1221 that has been claimed, we arc in the process
t23i of' -"wc" being Philip Morris, since this is a
rr41 Philip Morris document -"arc in the process of
(zsl digging our own grave. I believe that the program
Page 33 - Page 36 (12)
State of Florida v.
American Tobacco Company, et aL
I Page 35
t(+1 as set up has the potential of great damage to the
i m industry, and I strongly urge that the whole
i pl relationship of our company to CTR be carefully
E41 reviewed.
~ tsl "I am very much afraid that the
(e1 direction of the work being taken by CTR is
m totally detrimental to our position and undermines
(el the public posture we have taken as outsiders."
191 And it's signed, I ask you to assume, by
t,oi Dr.Osdcne.
tI+) Now, Doctor, shortly after the date of
(+z( this memo, which was November 29th,1977, was
pi Dr. Kreisher terminated?
(,41 A: It would appear so. I don't know the
psl dates, but November of 1977, and if he was
(te1 terminated in early or mid-1978, the timing is
pi certainly appropriate.
(,el Q: If I ask you to assume that by thc
tisi early fall of 1978 Dr. Kreisher had been
(zol terminated, would that be consistent with what you
Iz+) just said?
(zz( A: Yes.
t2a) 0: Now, when was the large scale mouse
(z4) smoke inhalation study which was designed to study
(zsl chronic smoke inhalation initiated, do you recall?
Page 33
Page 34
r) A: We had a series of long term
m inhalation studies in mice approved by CTR and the
t31 Science Advisory Board during 1980.And we had
I w been sort of building up to that during the time
(si beforehand because of development of the
(61 equipment.
m So it was started in - we were
(al approved to start in - a large series in 1980.
pi Was there another part to your question?
(1ol Q: No, I think you answered that.Thank
t++l you. Doctor, I want to ask you a general
(+z( qucscion.As a scientist who has been involved in
(,31 research since -
(+41 A: Can I clarify something?
(+sl 0: Yes, ma'am. Sorry.
psl A: There are a series of studies that
(,7l we're going to have to make sure we get the dates
(iel right, because we had initiated a study in 1978,
t+sl and we then subsequently got an approval for a
rm series of other studies. So let's make sure we
t2+1 get the dates quite clear.
IrzJ 0: Yes, ma'am.As to the long term
tzal chronic study, that was initiated when?
(24l A:'We started a study in '78 that we had
(zsl approval for a second series, I guess is the way
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Min-U-ScriptO A. Wm. Roberts, Jr. & Assoc.
CTR HN 04 I-f"`ft"a

State of Florida v.
Carol J. Henry, Ph.D.
AmLrlcan Tobacco Company, et aL My 31, 1997
nt to put it, after that.
tzl 0: And what were you trying to find out
P1 in that study?
t4t A: We were trying to determine whether
tsi mice could be exposed for long periods of time and
tsl what the biologic activity was of cigarette smoke
m in this animal model system.
tel Q: Now, did there come a time when the
t9i study was caused to be terminated?
t+a; A: Yes.
t++l Q: And would you explain that, please?
hzl A: After having received approval within
1131 the same year, I think the long term study was
t+41 initiated in 1978, and then in July of 1980, CTR
psl informed Micro that it would not support this, and
pel in fact they were going to phase the entire
t+71 contract down.
hal 0: Do you have personal knowledge of
t+sl that?
rrol A: Personal knowledge of...
tz+l Q: The fact that it was tecminated.
= A: Yes. I was responsible for phasing
n down the contract and completing what had been
tz41 initiated, negotiating what we could finish and
Izsl what would be the end disposition of all of the
t+l materials, animals and information.
tz; 0: You were project director?
pl A: Yes. .
t41 Q: Now, how many - it's tough for me to
tsl do honor to Mickey when I say this, but how many
ts; mice were studied? And explain how you designed
m the study from the standpoint of mice that were
tel exposed to smoke versus mice that were not.
ts; MR. MERRITT: Ron, can I just ask what
pol study we're talking about?
tI MR. MOTLEY: The long term inhalation
t,r, study.
1131 BY MR. MOTLEY:
114; 0: You understand that's what I'm asking
t+sl you about noa, Dr. Henry?
ti el A: Yes.NCe may have to refer to some
t171 numbers, because as we demonstrated before, there
p al acrc lots - this was a very large program, there
t191 a'ere a lot of studies.The chronic study that we
tzcl did complete, the long term chronic study - there
t2+1 n-ere - maybe we can brea.k this up.
122: There was a study initiated first to
trl test the equipment, that was of about 12 to 15
n<I months' duration, and then the second study was to
tzsl be a lifetime study which ended up lasting longer
Page 39
t+t than - probably 24 to 36 months.
tzl Q: When you say "lifetime," you mean
(3) lifetime -
141 A: Of the mouse.
tsl 0: Of the mouse.
lel A: Yes. During that study, the challenge
m was to make sure we had a sufficient number of
tat animals to both truly test the equipment on the
tsl animals and to have a sufficient number of animals
t,ol that had been exposed for a long period of time so
t,il we would be able to try and judge what had
pzl happened during that study.
1131 0: Do you feel that the study was
t+41 properly designed -
t+sl A: Yes.
1161 0: - scientifically?
nrl A: Yes.
t+el 0: And what was the result of the study
h91 when you compared the animals that were exposed to
po1 smoke versus animals that were not exposed to
rr+l smoke?
rm A: It was - we tried it a number of ways
mt to evaluate the data, and the shorthand answer to
1241 that is that the smoke exposed ani.mals had more
(2sl types of - one particular type of cancer compared
Page 37
~ Page 40
~ t+l to the sham exposed.
t7l Scientists use a technique called -
nl they try and statistically evaluate the results of
14] these studies, and the results of these studies
ts] did not achieve a probability of replication
i tel within the ranges the scientists like to use.
[71 Let me give you an example. In
; tel general scientists like to use something like a 5
191 percent probability that this study is
t,ol significant.That means if you were to do the
t++l same study over again, you would have a 95 percent
(+zl chance of repeating and getting the same results.
t+31 Our results showed that we would have
t+41 about a 93 percent chance, as opposed to 95, of
t+s1 getting the same results, meaning that the smoke
I(+el exposed animals would have more lung cancers than
ti7) the control animals.
It+el 0: In documents that you produced here
!t»I today, the number of 19 out of 978 smoke exposed
itpl mice developed lung cancer, and seven out of 651
~1211 of the nonexposed developed lung cancer, does that
pm refresh your recollection?
rnt A: Yes.
R41 Q: That's almost twice as many?
r2sl A: Yes.
Page 38
A. Wm. Roberts, Jr. & Assoc. Min-U-Scripto
(13) Page 37 - Page 40
C-"*TR VIN 0`'°~ 1'>'r"7F`--1

C.arol J. Henry, Ph.D.
.
JulY 3;tf 1997 American Tobacco Company, et aL
Page 41 I
111 0: And from a statistical standpoint,
m that reached what level of confidence?
Pl A: The scientific notation is a
tal probability of point 07.And the bright line that
[sl had been applied was point 05.
(s1 0: So you were slightly below the bright
m line?
181 A: Right.
191 0: Does that mean the study was not any
(,oi good?
(++] A: No. It suggested that there was
(+zl absolutely something happening to these animals in
(1sfterms of development of lung cancer, that there
(141 were suggestions of what might have to be changed
(+sl to actually explore this a little bit more, to
1161 understand what the mechanism of disease was or
(+7i the causation was in both exposing the animals to
t1al smoke and undcrstanding what were the biological
(,si changes that occurred to result in this.
rm 0: Would it be accurate or inaccurate for
tz+j someone to have claimed that your study that you
c,m just described was negative, that is, that it
r4 didn't prove - or proved that cigarette smoke did
(241 not cause lung cancer in animals?
[zsl A: I think it's inaccurate to say the
I+( study proved that cigarette smoke did not cause
m cancer.
131 Q: Do you believe that the study was
141 scientifically imporrant?
(si A: Yes.
;6, o: Why?
m A: Because there were very few facilities
(a] or abilities to expose the animals; and in the
(sj rigorous way it was looked at.
1101 0: And by "rigorous" you mean what?
(++] A: Meaning we were able to control the
(ir way the smoke was generated, to document that the
(,a; smoke had been delivered to the animals, that the
(14) pathology had been done correctly, and that we
(isi could - I belicve we could have reproduced the
(1s1 study and been able to build from that study to
(1r, ask other questions about what this really meant
(,e; in terms of disease and the animal model.
(,g; 0: Did the experiment and its results,
tzc; were they supportive of the hypothesis that
rr; cigarette smoke causes lung cancer?
(22; A: Yes.
tza: Q: Any question in your mind about that?
(124l A: No. I think the issue is that we
(zs, cannot do experiments on people.
Page 41 - Page 44 (14)
Page 42
~ Page 43
I+l 0: We're not supposed to, are we?
m A: And so the point is that animals and
t3i people have some similarities and some
(4l differences.The fact that we were able to
(sl achieve this result seemed to us very important to
161 understand further what the complexities were with
m regard to this chart.
(al Q: Chart being Exhibit 1?
tel A: The stages in carcinogenesis.And the
(,ol reason this was so important was there are - if
(++1 you're trying to model it from the human point of
t+z( view, there are people who get lung cancer and
(+al it's very closely associated with cigarette smokc,
(14) and others who apparently have lung cancer who did
(+s] not get this, and others who smoke who don't get
(+sl cancer at all.
(+n Those are very complex issues. And
(+al from a public health point of view, in order to be
I(19l protective and understand, we wanted to try and
(zol study that.That seemed to be what we were about.
(x+l Q: When did the lawyers for the cigarette
(zzl industry start becoming involved in monitoring
rn( your scientific research, Doctor?
~fz41 A: Let me clarify that it was the lawyers
~(zsI for the Council. I'm not aware of lawyers for the
t+l actual individual companies.
m Q:Okay.
P( A: When the decision was made that the
(Aj contracts would not be - were going to be phased
;(si out, and that the Council was going to fund
i(el grants, the lawyers started to, as I recollect,
, m accompany Dr. Gardner, who was then our point of
i tel contact with the Council, and were present most of
t9i the time, as I recall, in our interactions, the
(+oi scientific staff with the Council.
t++I Q: And you had been a research scientist
(1z1 for how many years, Doctor?
1131 A: A long time. 19,20, 30 years.
(14) Q: In your personal experience have you
(+sl ever seen lawyers as involved with scientific
1(+sl research as occurred during this period of time
It171 with the Council forTobacco Research?
0e] A: In all the years that I have had
1t19t contracts either at the bench or as a consultant
;zoj in doing a wide variety of controversial projects,
p+; I've never had that kind of involvement.
= Q: Of lawycrs?
'rn( A: Right.
(z4l 0: Now, Doctor, let's focus on the
psl closing down of the inhalation study. Did you
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State of Florida v
CTR MN 041 *fr`80

State of Florida v.
Carol J. Henry, PhD.
American Tobacco Company, et aL July 31, 1997
1+1 report your results to the Council forTobacco
r2l Research on a periodic basis?
(al A: Yes.
(4) 0: At a point in time you were notified
(sl by the Council for Tobacco Research that the
(6) chronic inhalation study was going to be
m discontinued?
(a) A: That we would complete one, that we
(9) had started a series of others, and that we would
(,o) then - I believe it was probably our initiation
(I+) to redesign those studies so that we could get the
(+21 most information from them before we had to close
(1al the inhalation facility.
(+41 0: At some point in time, though, funding
(+sl was to be cut off?
(,61 A: Yes.
(+7) 0: As a scientist involved in this study
(,e) which you characterized yourself as important,
(,sl what is your opinion about - from a scientific
(zo) standpoint, of whether or not the termination of
(z,l your studies was premature, scientifically well
(22) advised, or scientifically ill-advised, and why?
(zal A: I believe it was scientifically
(241 ill-advised, for the reasons that this is a very
(zs) large, important industry that had lots of
Page 46
(+) customers, lots of clients, and to not be able to
(zl answer in a credible way fundamental questions
(al about the potential for this material to be
(<1 causing serious disease, not just cancer but other
(sl diseases, it seemed to me that this was not an
(61 advisable thing to do.
m And let me say that the reason I felt
(sl this was important is that the Council had during
tel the time of my initiation of employment been very
(,ol attentive to try to make sure that the inhalation
nq experiments and the work that was done was done in
(,21 a credible way, and that they recognized that an
(1al inhalation facility had to be funded by a
(+41 responsible group in order to get the best kind of
(isl work out.
(,61 And to stop that seemed to me to not
t+7l be - not be very advisable.
(,sl Q: Did you form a conclusion based on
(+91 your own personal experience as to why this
(zal contract to study long term effects of smoke on
(2+1 anitnals in regard to disease was terminated, based
(z21 on your own experience?
(ral A: Well, the issue seemed to focus on the
(24) liability aspects of the contract versus grants.
czsl And in fact that was the major reason that was
Page 47
p1 given to us.The decision by the Council - it
(m was their decision to make if they chose to not
t31 continue the contract or not. But that seemed to
(4) be the decision.
(sl 0: Now, what do you base that - first of
(61 all, what do you mean by "liability"?
m A: I don't know. I mean, those are the
(a) terms that were used.We were concerned that
(el given the way the experiments were going and what
(+o) we were discovering, that in fact - that
(++1 answers - that people did not want to know what
c+21 the answers were.
1131 0: What people?
(,41 A: Whoever was funding or associated with
ps1 directing the Council.
(,sl Q: Didn't want to hear what you had to
t+71 say?
(,s) A: Or were concerned about where these
(,s) kinds of studies might go.And it would appear-
(zo) I mean, I'm astonished at this document.
12+1 0: Which one?
rM A: Exhibit 2.
p1 0: The "digging our own grave"?
t241 A: Yes.
(zs7 0: Is that consistent with what you were
Page 45
Page 48
told by CTR)
A: They never, ever used terms like that.
0: "Digging our own grave"?
A: No. But it would be - I guess I
would conclude that the concerns that were raised
about the way the research was going and what we
might eventually develop given the kinds of
results we had to date, that there must have been
concerns that this would damage the industry.
0: You base this on your own personal
observations?
A: Yes.
Q: And when you say "we were told," you
arc referring to yourself being told by CTR
officials?
A: Yes. I mean, we have no - in
contract research you have a contract, and there
is a clause in the contract generally that says
the sponsor can canccl the work at any time with
certain kinds of notification, et cetera.
So that the Council did not have to
explain to us, any more than it had to explain to
us why Dr. Kreisher had been terminated, and which
they did not.Thc contractor and the sponsor has
the abiliry to do that.
A. Wm. Roberts, Jr. & Assoc. Min-U-Scripto (15) Page 45 - Page 48
CTR- ~ IN ~°°..~4 17"`a I

Carol J. Henry, Ph.D.
July 31, 1997
t,) So we certainly asked questions, and I
m expect it was - you know, this was the decision
(sl that was made.
t41 0: It's the way business is done under
tel contracts?
(sl A: Yes.
m 0: Now, did there come a time as you were
(ei closing down the long term mouse study that you
m attempted to write up the results of your study?
(,ol A: Yes.This had been an association
(I between Microbiological Associates and the Council
(,21 for many years, and there were many aspects to
(,s1 this.As I mentioned, we had collaborators, and
(,4] it was desired to try and have some record of this
(,sl amount of work.
1161 So we agreed with the Council to write
(,n a final report and try and capture this
(,al information as well as trying to analyze the final
(,sl pathology and statistical analysis of the one long
(zq term study that was completed.
(211 0: How long did it take you approximately
(zzl to complete this final report?
(z3l A: As I remember, it was about six
(z4l months.
[zsl 0: And were your final report efforts
(,l monitored by anyone from CTR?
m A: Yes.
p] Q: Who was that?
(4l A: We were always in contact Rith CTR,
(sI with at that time Dr. Gardner.
(s1 0: Excuse me one second.
m MR. MOTLEY: Are you picking up that
Isl truck?
(sl THE VIDEOGRAPHER: Yes.
(+q BY MR. MOTLEY:
(+,l 0: Will you start over again and tell us
(+z( who at CTR monitored the writing of the final
(1a1 report?
(,41 A: CTR had a scientific staff. It was
(+sl headed by Dr. Gardner. Dr. Gardner was the person
(1s( that we would consult with about this. But as we
n-n started completing the work or doing the work on
t,sl the final report, it changed again a bit in that
(1sl there were definitely directives from the
(z0( attorneys.
(211 Q: From the lawyers?
(zz( A: Ycs.
tz3l 0: For whom?
(241 A: For the Council.
(2sl 0: Do you know the name of the lawyers?
Page 49 - Page 52 (16)
State of Florid.: v .
American Tobacco Company, et aL
Page 49
(,l A: The person I remember most vividly was
m a Mr. Finnegan.
[3I Q: Mr. Finnegan from Jacob, Menninger &
(4l Finnegan?
(sl A: That sounds correct.
(sl 0: If I told you they represented R. J.
m Reynolds and Council forTobacco Research, would
(al that surprise you?
(9l A: I didn't know that.
(+o1 Q: Go ahead. So the lawyers got involved
p+l in the writing of the final report or the
(+2] monitoring of it?
(,al A: In trying to shape the final report
p4I and what could and could not go into the final
(+sl report, it was agreed - we were told that what we
(,s1 should have is a - try to capture the data
n7l without interpretation, without direction of where
nal one might conclude or what hypotheses in
nq scientific terms one might mant to explore as to
(20l the meaning of these things.
rdsl This was meaning that you would
(zzl collect the data in this final report in a fairly
ml proscribed, limited way.
(z41 0: And who was setting these limits?
(zsl A: Mr. Finnegan appeared to have very
Page 51
Page 50
t+l strong feelings and directions about what should
(21 and should not be in this report.
p( 0: And Mr. Finnegan, again, is a lawyer?
(4l A: Yes.
(sl 0: In your long career, Dr. Henry, as a
(sl research scientist, have you ever experienced such
m as you have just described, that is, lawyers being
(al involved in the writing of the report and placing
(9i limits on what can be said?
(,ol A: No.
(>>I 0: Never have?
(+zl A: No.
(+a1 0: Not before that time?
(141 A: And not since.
(,s) Q: Describe for the Court and jury how
(+sl this lawyer, if I can use the term "looking over
p7l your shoulder," made you feel as a research
(+al scientist.
(,91 A: I objected to it and said that because
(zol the shape of the report, of the final report was
p,l altered, it - and I was told that the sponsor had
(2z( the authority to dictate this.
(2al Q: You were told by whom?
(x4l A: Both my management as well as the
(zsl Council.
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(,1 0: You were told that they had the right
M to do this?
pi A: Right.
(41 0: Now, this final report that was
Isi prepared with respect to the long term chronic
Isl mouse inhalation study, which produced I believe
m you told us 19 lung cancers as opposed to seven in
Ial the nonexposed group, who were the primary
(a1 scientific authors? Leave aside the lawyer
(,o] involvement.Who were the scientific authors of
I) that report?
(,z1 A: Dr. Kouri and I had - were the
(,31 primary authors.
(,41 0: Approximately when was this final
(,sl report, with the limitations that were placed on
(,s[ it as you have described, submitted?
(,71 A: I think the date was February of 1984.
[,s[ Q: Now, in the usual preparation of a
(+91 report and the submission of a scientific study to
(zol be published for other scientists to read, do you
(z+l present your data in a certain structured way?
(z2) What is the usual practice? Describe that, if you .
(zal would.
[z41 A: Most scientific publications will have
(zsl an introduction which describes why you're - and
(II the rationale for what you're trying to
(z] accomplish. It will cite references in the
!al scientific literature that support or suggest
(41 where - why you're designing the experiment that
(sl you're going to describe.
(6) There will be a materials and methods
m that will describe how you carried out the study.
Isi There will be a results section that will then
(sl describe the results of what you found.
1101 And then there will generally be a
(++1 discussion section in which you interpret your
(1z1 results in the context of all the other studies
I+a) that have been done or in which you relate
1141 similarities and differences to other either
(,sl similar studies or why you think this is an
hsl important piece of information.
I+7i Q: Were you allowed by the sponsors,
pel Council forTobacco Research and their lawyers, to
I+g) prepare the report in the normal way?
Izol A: Not for the final report.
(z1l Q: And what were you not allowed to do?
ra) A: The sort of general introduction about
[n( the rationale as well as the conclusions and
[z41 interpretation to put these results in a context
(2sl that might be better understood.
A. Wm. Roberts, Jr. & Assoc.
Carol J. Henry, Ph.D.
July 31, 1997
Page 53
Page 54
hl But the other point here is that this
m was never our understanding, that this final
p[ report would be anything besides for CTR reference
141 and our own internal reference.
Isl Q: In other words, it would not be
(s1 published to the other scientists?
m A: It wasn't that it was not of interest
Is[ or that it couldn't be read. But our intention
(9I was that without that kind of interpretation or
(,ol context, the final report might - in the way it
(I q was written might be difficult to understand or it
n2[ might not be understood.
(,a1 0: I'm going to hand you an Internet
p.l version of an article that appeared in the Wall
[+s] Street Journal dated February 11th,1993, entitled
(,s3 "Smoke and mirrors, how cigarette makers keep
(,n, health questions open year after year. Council
~(,el forTobacco Research is billed as independent but
jpel is guided by lawyers," by Alex Friedman and Laurie
ipl Coherr.
I(z,l Fir.sr of all, Doctor, have you ever
(zzl met Sis. Friedman, who is a Pulitzer prize-winning
cnl reporter?
(z41 A: I have not met her.
(zsl Q: Have you spoken to her?
(,[ A: Yes.
t2l 0: And were you aware that an article was
(3) published in part addressing the research you were
(41 involved in?
(s) A: Yes.
(sl Q: And did you speak with Ms. Friedman
m about your experience with CTR and the lawyers?
(al A: I did.
(91 MR. MOTLEY: Would you mark this
(iol please as Exhibit 3.
(++l (Henry Deposition Exhibit Number 3 was
[+zl marked for identification.)
(+3[ BY MR. MOTLEY:
[141 0: Doctor, in the interests of time I
(+sl have highlighted certain portions. First of all,
(isl I would ask if you this is a copy of the article
(+7l with which you are familiar that discusses your
(tel research.
(,sl A: This seems to be the article.
(zol Q: May I have it back, please? I want to
(z+I ask you about certain quotes or statements that
(m arc attributed to you and ask you if they're
rn[ accurate, if I might.
(z41 You are reported as telling in the
(zsl Wall StreetJournal article of February 1993.this
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Carol J. Henry, Ph.D.
July 31, 1997
(Il is attributed to you, "'The lab initially had
m considerable freedom: says Carol Henry, who was
r3l its director of inhalation toxicology,'but after
lal nine years of work and $12 million, the team was
(s7 told in 1982 that it could no longer meet with
)sl Council forTobacco Research staffers unless a
m lawyer was present: "
(a) Is that a correct statement?
Pi A: I think the date is - the date may
(,o) not be quite accurate. But that is definitely the
(>>1 sense of what we were told.
(,zl 0: What date would be more accurate than
l+al 1982?
hal A: I think it might have been a little
(+s) bit earlier because of the phase down:
(,a7 Q: You are quoted as saying, "'We had
1,71 never done science through lawyers before and we
(,e) told them it was unacceptable; says Dr. Henry."
(,91 Is that a correct statement that you made to her?
rm A: Mm-hmm (affirmatively).
(z,l 0: Is that what in fact happened, and you
rm said that?
p3l A: That's certainly the way it looked to
lzsl me.
12s) 0: That's what you observed?
(,1 A: (Witness nods in the affirmative.)
m 0: "She," meaning you, "says a Jacob
[31 Menninger lawyer told her, 'that's just the way it
lal is"' Did that happen?
(sl A: As I recall.
161 0: And that would be Mr. Finnegan?
m A: Yes.
(a) 0: Representing the Council forTobacco
[91 Research?
(+c] A: Yes.
(IIl Q: You were then quoted as saying,
(,21 "Dr. Henry says the study built a 'very strong
(1a1 case that cigarettes can induce cancers in
(1a) animals:" Is that a fair statement of what you
(+sl told her?
r,61 A: Yes.
(+n Q: And is that accurate?
(,a1 A: Yes.
(+sl 0: Is that your professional opinion?
(201 A: Yes.
cz+) 0: Then it goes on to say, "but lawyers
(221 from Jacob Menninger told Microbiological
p3) Associates that the project could go no further."
(2a1 And then it quotes you as follows. "'When a
Rs7 contract is canceled, given these kinds of
Page 57 - Page 60 (18)
State of Florio, v.
American Tobacco Company, et aL
Page 57
Page 58
(+1 results; Dr. Henry says, 'reasonable scientists
mmight conclude the liability issue must have
(3) suddenly become apparent to this group:"
(4) Is that a fair recitation of what you
(s) experienced?
(sl A: Yes.
m 0: Is it correct?
(al A: Yes.
m 0: Do you believe that?
(,ol A: Yes.
(+1) 0: From your own observation?
(121 A: Yes.
(131 0: And then it quotes Dr. Kreisher, who
(ul you have described, the Council's former associate
(+s) scientific director, as follows. "Council lawyers
(,sl 'worried like hell' about the research." Did you
(17) observe that yourself?
(,el A: Only in the actions that they took
(+9) of - and our interactions during the writing of
r4 the final report would I - and one could conclude
li,l that there werc conccrns by the lawyers.
tm 0: Now, did there come a time, D.r. Henry,
r41 when you learned that a book or a manuscript had
[z.1 been distributed to scientists, Congressmen, and
I Izs1 other people?
I
I
A: I didn't know that it had been
distributed in that way. But my first knowledge
of the book was when a reporter called me and
asked me questions about the publication from the
Council that had my name on it.
And I really - it took some time to
figure out what this book was, how this person had
such a book, and what in fact it meant.
MR. MOTLEY: Can we take a fiveminute
break now, please?
THE VIDEOGRAPHER: We're going off the
record.The time is 11:16.
(Recess.)
THE VIDEOGRAPHER: We are back on the
record.The time is 11:27 a.m.
BY MR. MOTLEY:
0: Dr. Henry, I'm going to hand you
Exhibit Number 4 and ask you to identify this, if
you might.
(Henry Deposition Exhibit Number 4 was
marked for identification.)
THE VIDEOGRAPHER: We're going off the
record.The time is 11:28 a.m.
(Discussion off the record.)
THE VIDEOGRAPHER: We are back on the
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State of Florida v.
American Tobacco Company, et aL
(+) record.The time is 11:28 a.m.
(zl BY MR. MOTLEY:
[3) 0: Dr. Henry, I've handed you Exhibit 4.
(4j Can you identify that for the record, please?
(sl A: This seems to be the book that - or a
161 copy of the book that was published by the Council
in entitled Chronic Exposure of Mice To Cigarette
[e1 Smoke.
1e1 Q: Were you aware that the Council for
(10i Tobacco Research was publishing that book?
[++] A: No.
1121 Q: You were not?
[61 A: No.
1141 Q: And what is contained in that book?
(,sl A: What it says on the first page is that
(,e] it is the final report of research performed under
(17i contract entitled "Smoke inhalation studies in
(1el mice" between Microbiological Associates,
(i91 Bethesda, Maryland, and the Council forTobacco
(zo) Research-U.SA., Incorporated, New York, New York.
1211 And what it looks like is the final
(rr( report that we had submitted to the Council as a
(231 result of closing down the contracts at Micro.
[241 0: Is it in fact identical to the final
(zsl report that you submitted?
[,l A: It is not identical.And I was told
(21 it was identical with the exception of having a
(o[ foreword inserted into this book by Dr. Sheldon
[41 Sommers.
(sl 0: Who is he?
(6) A: The scientific director for the
m Council during 1984. 1 believe he succeeded
(el Dr. Gardner.And so there a foreword by
[91 Dr. Sommers and the other part about this is it's
(,ol been slightly rearranged from the way we submitted
(++l the document to the Council.
[12( 0: In what way, Doctor?
1131 A: We submitted the final report so that
(14l following the table of contents was a summary of
l,sl what was in the document, followed by chapters
(161 that had an introduction and then describing the
[171 facilities, et cetera.
[18[ And what has happened is that the
(,el introduction has been inserted after the foreword,
(20l and part of the introduction describes the
(211 inhalation facility, the equipment and the
[m logistics of doing a large inhalation facility,
(z3j which doesn't refer only to one experiment, it
(241 really talks about the facility, so it's a very
rzsl large issue.
Page 61
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Carol J. Henry, PhD.
July 31, 1997
(+l And then it's followed by the summary.
[21 So I was surprised to discover - and I only
t31 discovered this recently, as I was trying to
(41 understand why this had been done. I don't know
(sl why it was done. I can surmise, but I don't know
[61 for sure why it was done.
m Q: Well, without surmise, Doctor, did the
(e( alteration of the final report from the way you
(el had presented it to the form it took in this book
[,ol have any affect in your view on the ability of a
[11( reader to understand the significance of what was
[+21 done?
(131 A: Yes. It is my - as one reads this,
(141 by coming upon the first - the foreword by
(,s] Dr. Sommers, then followed by this introduction to
(,el the facilities where the summary and some of the
(17) other results are not accomplished until the end,
(,sl the impression I think is very different.
11191 The summary itself that has been
(zol inserted by Dr. Sommers is an interpretation of
(21l the work we did, which we were not allowed to
(zzl write, or at least Dr. Sommers did not consult
Iml with us when he put that in.
rui And so there is an impression here,
(zs( and in fact what Dr. Sommers says in his foreword,
Page 63
Page 64
[ll he gives the results, but he says that the
m experiments represented a determined effort to
Iot develop a suitable model, and it is believed that
(.l the report will be of interest.
[s) He then goes on to - his final
(61 statement is,'The overall numbers of pulmonary
m neoplasms identified were not significantly
[s) different from the smoke exposed mice compared to
(9j the sham."
(10i 0: Is that true?
(++l A: That is true.That's why it's kind of
[121 intriguing, that that is the point he chose to
(131 pull out from this entire report.And one would
(ul then conclude from the way this is written that I
1(+si think the impact of the results would not then
161 encourage further discussion and tended to
171 diminish discussion about these results.
[+e; 0: Doctor, I'm handing you what will be
[i9( Exhibit 5.
rr.( (Henry Deposition Exhibit Number 5 was
(z+[ marked for identification.)
irm
BY MR. MOTLEY:
i(z3; 0: I will ask you, Doctor, to assume this
(z4) was produced by the Council forTobacco Research,
Rsl and that Leonard Zahn is a public relations
A. wm. Roberts, Jr. & Assoc. Min-U-Script®. (19) Page 61 - Page 64
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Carol J. Henry, Ph.D.
July 31, 1997
(>> consultant to the Council forTobacco Research.
m It's dated November 9th,1984.
(3) And it's entitled "Findings published
(al on cigarette smoke, inhalation study with mice."
(sl Now, first of all, Doctor, did CTR seek your
(61 permission to publish the book in the form that it
m takes as represented in Exhibit 4?
(al A: No.
(el Q: Would your interpretation of the tests
(,ol that you performed personally have been the same
(>>1 as Dr. Sommers states in his foreword?
(,zl A: No.
p31 Q: You would have stated it differently?
(,y A: Yes.
(+sl Q: What major difference, if you had been
t,si allowed to do so by the lawyers for CTR, would you
(,7i have said that's different from what Dr. Sommers
(,el said in this report?
(,si A: In fact Dr. Kouri and I believe that
(201 the results of our study showed that cigarette was
(211 weakly carcinogenic to mice.
t24 Q: "Weakly carcinogenic to mice" meaning?
(zm A: Meaning that while not a strong
(2a1 carcinogen, that the results suggested definitely
(2s1 a carcinogenic response in this animal model after
exposure to smoke.
0: And that conclusion is not in what CTR
published?
A: It is not.
0: Indeed, the opposite is reported?
A: It is certainly suggested in that
interpretation.
0: That it was a negative -
A: It was a negative result.
Q: And that's not what you concluded?
A: That's not how I would interpret the
conclusions and results of our study.
0: And you're the one that did the study?
A: We are.
0: And Sommers did not do the study?
A: No.
0: In fact Dr. Sommers wrote you and told
you that, did he not?
MR. MOTLEY: This will be Exhibit 6.
(Henry Deposition Exhibit Number 6 was
marked for identification.)
BY MR. MOTLEY:
0: Doctor, did you receive this letter
tao years after this book was published?
A: Yes.
Page 65 - Page 68 (20)
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State of Florid~aa v.
American Tobacco Company, et aL
(+) 0: And this is Dr. Sommers's signature,
m to your knowledge?
(3) A: Mm-hmm (affirmatively). It is.
(d)
Q: And he writes to you, "I would go over
(sl it," which is a study that I'm going to get to in
(sl a minute, "for mild editing of grammar like
(rl Ms. Fiditch, the schoolteacher.You know I do not
(sl deal with substance as this is your and Dick's
(si prerogative."
(+ol How did you interpret that?
(1 A: I found it a little surprising given
pzi that he is certainly capable of dealing with
(131 substance, and it was kind of a surprising letter.
(,a1 That was probably - I think that might be the
(+sl last interaction and correspondence I had with
(,s[ Dr.Sommers.
(171 0: Now, look at Exhibit 5, if you will,
(+el the press release.
(+el A: Yes.
(zol 0: Do you have that in front of you?
(zi1 A: IN4m-hrra,i (affirmatively).
(zzl 0: Have you reviewed that, Doctor?
(z31 A: Mm-hmm (affirtnatively).
(z.l Q: Is there anything in this press
(zsl release from the Council forTobacco Research
(Il which is untrue?
(zl A: Yes. I think it is actually quite
(31 misleading.This press release was represented as
(al if this is talking about a single study.And in
(sl fact it refers to a nine-year study. It goes on
(6) further to indicate that 10,000 mice inhaled the
m smoke from over 800,000 cigarettes during this
(al study.This actually refers to the entire smoke
(91 inhalation facility.
(+ol And subsequently then it goes on as if
(1 this were one single study that's being reported
(+sl as opposed to the amalgamation of many studies
(,31 over the time.And I think the point is that it's
(i.l attempting to overwhelm the reader with large
(+sl numbers.
(,sl It is - Dr. Sommers's foreword is
o7) quoted here, and then it goes on.Thcre are some
(,el other incorrect statements.This is just simply
(+sl not written technically in a responsible way.
(201 Q: What do you mean by "not written in a
(x,l responsible way"?
(2s1 A: Because the implication - again, it's
(231 without some of the context.'Tests showed the
(z.1 mice inhaled at least 90 percent of the smoke."
(zsi That's not correct.
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