Dr. Michael Thun - Testimony Excerpts
1
7 MR. SWEDLOW: Good morning, Your Honor.
8 THE COURT: Good morning.
9 MR. SWEDLOW: I would like to call Dr.
10 Michael Thun to the stand.
11 (Whereupon, the
12 witness was sworn
13 at this time.)
14 -- -- --
15 DR. MICHAEL THUN
16 called as a witness by the Plaintiffs in this
17 cause being first duly sworn, was examined and
18 testified as follows:
19 DIRECT EXAMINATION
__________________
20 By Mr. Swedlow
21 MR. SWEDLOW: (Q) Please state your
22 name and address for the record?
23 A. Michael J. Thun, T-h-u-n.
24 Address is 564 Ridgecrest Road, one word,
93
1 Atlanta, Georgia, 30307.
2 Q. By whom are you currently employed?
3 A. The American Cancer Society.
4 Q. And what is your current position and
5 title?
6 A. I am the Vice President for
7 Epidemiology and Surveillance Research.
8 Q. And what does the Vice President of
9 Epidemiology and Surveillance Research do at the
10 American Cancer Society?
11 A. Direct a group of about fifty people.
12 The department has existed since the 1940s and it
13 has two arms.
14 The one arm enrolls very large studies such
15 as we'll be discussing this morning of the
16 million plus people, and looks for the factors
17 that cause or prevent cancer; and the second arm
18 does surveillance of cancer occurrence,
19 mortality, survival, and major risk factors for
20 cancer like smoking.
21 Q. We're going to have to define some of
22 the terms for the Court today.
23 You referred to two large million person
24 studies.
94
1 What are those called?
2 A. The two studies that we'll be talking
3 about Cancer Prevention Study One or CPS-I which
4 began in 1959 when volunteers for the American
5 Cancer Society enrolled about a million people in
6 twenty-five states, and then those people were
7 followed for twelve years and periodically
8 recontacted to assess changes in their smoking
9 status.
10 And the analyses relate mortality during
11 that twelve year period to the smoking status at
12 the beginning and during the course of the study.
13 Q. From the beginning of that CPS-I to the
14 end of the follow-up, what is the time period for
15 that?
16 A. Twelve years.
17 Q. Starting with what year and ending with
18 what year?
19 A. Starting with 1959 and ending with
20 1972.
21 Q. Okay, and what is the other million
22 person study you referred to?
23 A. Cancer Prevention Study Two or CPS-II
24 was begun the same way by the American Cancer
95
1 Society in 1982. It enrolled nationwide just
2 under 1.2 million people, and the follow-up of
3 those people continues to the analyses we'll be
4 talking about today are based on the first six
5 years of follow-up.
6 Q. Okay, and what is your responsibilities
7 specifically with respect to what we now know is
8 CPS-I and CPS-II?
9 A. Well, when I first came to the American
10 Cancer Society in 1989, I was the Director of
11 Analytic Epidemiology, and so I had direct
12 responsibility for analyzing and supervising
13 analyses of those data sets.
14 Now that I'm the head of the department, I
15 still am responsible, but my responsibilities are
16 broader.
17 Q. Let's take a step back and go through
18 your educational background.
19 Where did you go to college and when did
20 you graduate?
21 A. I went to Harvard College, and I
22 graduated in 1970 cum laude in English.
23 Q. Congratulations.
24 When did you start college?
96
1 A. I started college in 1962, and I had
2 four years in the middle of college, three of
3 which I was a medic in the U.S. Army.
4 Q. And then what was the next step in your
5 educational process?
6 A. After college, I did a year of
7 pre-medicine at Harvard, and then I went to
8 medical school at the University of Pennsylvania.
9 Q. And where did you -- first I'm going to
10 try to speed this up so I don't bore anybody,
11 where did you first work after finishing medical
12 school?
13 A. I -- I did my internship and a year of
14 residency in internal medicine at Shands Teaching
15 Hospital in the University of Florida in
16 Gainesville.
17 Q. Now, jumping ahead to the first time
18 you had responsibilities within your job for
19 epidemiology, when was that?
20 A. In 1978 I went to work on State Health
21 Department in New Jersey investigating toxic
22 exposures with the state epidemiologists. That's
23 when my epidemiologic work began.
24 Q. Let's define what you understand to be
97
1 epidemiology. Meaning explain what that is?
2 A. That's a study of disease in
3 populations. So whereas clinicians work with
4 individual patients and so biologists work with
5 individual cells; the framework for epidemiology
6 is populations.
7 Q. And for how many years adding all of
8 your experience up, have you been involved in
9 epidemiological analysis?
10 A. Approximately twenty-five.
11 Q. When did you first work for -- well,
12 have you ever worked for the Center for Disease
13 Control?
14 A. In 1980 I became an epidemic
15 intelligence service officer which is a two year
16 program that the CDC runs, and I was based with
17 the National Institute of Occupational Safety and
18 Health in Cincinnati.
19 Q. Have you had -- received any other
20 degrees after finishing your medical degree?
21 A. After completing that two years, the
22 CDC gave me a long-term training award, and I
23 went to the Harvard School of Public Health for a
24 year and got a Master's in Science and
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1 Epidemiology.
2 Q. And then you returned to the CDC?
3 A. Then I returned to NIOSH which is part
4 of the CDC, and I had sort of a series of
5 progressively more supervisory jobs, and as a
6 section chief I supervised occupational
7 investigations of a broader array of occupational
8 toxins.
9 Q. Was your work at the CDC involving
10 epidemiology?
11 A. Yes.
12 Q. Then when did you join the American
13 Cancer Society? I think we went over this
14 already.
15 A. 1989 I joined as the Director of
16 Analytic Epidemiology.
17 Q. And when did you obtain your current
18 title of Vice President?
19 A. In 1998 I was promoted to the Vice
20 President position I have now.
21 Q. Can you explain to the Court again what
22 the difference is between your responsibilities
23 pre-1998 and your responsibilities after you
24 became Vice President?
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1 A. Well, pre-1998 I was responsible for
2 analyses of the cohort studies on one arm of the
3 department. After 1998 I also became responsible
4 for the surveillance arm of the department.
5 Q. Do you have any teaching experience at
6 the post-graduate level?
7 A. I have adjunct professorship
8 appointments at the Rollins School of Public
9 Health of Emory University where I teach several
10 courses, and I have another adjunct appointment
11 recently with the medical school at Emory at the
12 Cancer Center.
13 Q. Without going through all of your
14 adjunct faculty appointments, do any of those
15 appointments relate to epidemiology?
16 A. They all do.
17 Q. Now, I'm going to ask you about your
18 involvement in some tobacco-related advisory
19 groups. If you could, just tell us what these
20 acronyms actually mean.
21 The first one is SAMMEC. What is that?
22 A. SAMMEC stands for Smoking Attributable
23 Mortality Morbidity Economic Costs. It is a
24 program that the Center for Disease Control the
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1 office of smoking helped develop to estimate
2 deaths from smoking in the United States, and the
3 analysis is based in part on the American Cancer
4 Society toll boards.
5 Q. And have you ever been involved in any
6 Surgeon General report drafting?
7 A. In several I was an author on the -- in
8 chapters of the women and smoking. Just recently
9 I authored four sections in current Surgeon
10 General Report updating the information on the
11 diseases caused by smoking.
12 Q. Next have you advised the Australia
13 Veterans' Administration?
14 A. Right.
15 I was an advisor in a group that convened
16 to give them guidance about whether prostate
17 cancer should be included as a tobacco
18 compensable disease.
19 Q. And have you given advice to OSHA in
20 the past?
21 A. OSHA, yes, I have.
22 OSHA contracted with Johns Hopkins to pull
23 together the current scientific information on
24 environmental tobacco smoke particularly exposure
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1 in the workplace, and I produced two papers on
2 cardiovascular effects of secondhand smoke.
3 Q. And have you -- this will be the last
4 one.
5 And have you participated in World Health
6 Organization Monograph Processes?
7 A. This last year and last summer, I
8 participated in the working group of the
9 International Agency for Research on Cancer IARC
10 which is the branch of the world health
11 organization that deals with cancer. And they've
12 put out monographs or books on major factors that
13 cause cancer, and this summer we updated the one
14 on tobacco.
15 Q. Okay. Now, speed up the end of your
16 qualification process here, I'll just read out
17 some journals, and you tell me if you have been
18 on the editorial Board or not.
19 The first journal is called Epidemiology.
____________
20 When did you first get on the Board of -- the
21 editorial Board of Epidemiology, the journal?
____________
22 A. From the creation of the journal which
23 was around 1990 till about a year ago.
24 Q. How about are you currently on the
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1 editorial Board of the Encyclopedia of Public
______________________
2 Health?
______
3 A. Yes.
4 Q. How about Cancer Epidemiology
___________________
5 Biomarkers and Prevention?
_________________________
6 A. Yes.
7 Q. I'll run through -- I'll ask you if you
8 have been a reviewer for these peer-reviewed
9 journals.
10 First one is the New England Journal of
______________________
11 Medicine?
________
12 A. Yes.
13 Q. The Journal of the American -- American
___________________________ ________
14 Medical Association?
___________________
15 A. Yes.
16 Q. The journal we just talked about,
17 Epidemiology?
____________
18 A. Yes.
19 Q. The American Journal of Epidemiology?
________________________________
20 A. Yes.
21 Q. The Journal of the NCI?
__________________
22 A. Yes.
23 Q. The American Journal of Public Health?
_________________________________
24 A. Yes.
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1 Q. The American Journal of Industrial
______________________________
2 Medicine?
________
3 A. Yes.
4 Q. Cancer?
______
5 A. Yes.
6 Q. What is the Cancer journal?
______
7 A. It's the journal -- it's one of the
8 journals of the American Cancer Society.
9 Q. Okay.
10 The journal called Cancer Causes and
_________________
11 Control?
_______
12 A. Yes.
13 Q. Cancer Epidemiology Biomarkers and
__________________________________
14 Prevention?
__________
15 A. Yes.
16 Q. Tobacco Control?
_______________
17 A. Yes.
18 Q. Have you ever testified -- you were not
19 here for this testimony, but I'm going to ask you
20 this question relating to earlier testimony that
21 was given.
22 Have you ever testified against a tobacco
23 company or against the tobacco industry in any
24 litigation before today?
104
1 A. No.
2 Q. Are you being paid for your work in
3 this case?
4 A. No, the reimbursement for my time is
5 going directly to the American Cancer Society.
6 Q. Why is the American Cancer Society
7 allowing you to participate in this litigation?
8 A. Well, cigarette smoking alone causes
9 about thirty percent of all cancer deaths in the
10 United States, and since the 1950s when the
11 American Cancer Society first began to recognize
12 how important tobacco use was to cancer, reducing
13 tobacco attributable disease has become a major
14 part of the ACS mission, and the courts are one
15 of the approaches in reducing tobacco use and
16 tobacco attributable disease.
17 Q. Okay. I know you defined this for us
18 briefly already, but can you tell us again what
19 is epidemiology and what exactly is it used for?
20 A. Well, in the case of tobacco,
21 epidemiology provides a great amount of the
22 information of what diseases tobacco products
23 actually cause in humans. Because animals -- for
24 most animals tobacco smoke is extremely toxic,
105
1 and they won't smoke voluntarily and experimental
2 studies, clinical trials, are unethical because
3 you can't do trials with poisons and carcinogens.
4 And so epidemiologic studies are -- have been a
5 major importance.
6 Q. How long have you personally been
7 intensely focused on the epidemiology as it
8 relates to tobacco?
9 A. Since the early 1990s.
10 Q. And for what time period have you been
11 intensely involved in reviewing that literature,
12 and what I mean is what period of time does that
13 literature cover?
14 A. The vast literature on epidemiology and
15 tobacco really begins in -- in 1950 and continues
16 to the present.
17 Q. And have you studied specifically the
18 exchange of information between epidemiologists
19 on the one hand and the tobacco industry
20 including Philip Morris on the other hand for the
21 past fifty years like you just referred to?
22 A. Right. I'm not sure I recall it
23 exchange of information.
24 Basically the dynamic between the tobacco
106
1 epidemiologists and the tobacco companies from
2 1950 until the mid-1990s was -- was one in which
3 the tobacco industry was denying that -- that --
4 that tobacco caused series disease.
5 So I have studied so many of the
6 epidemiologic studies were providing evidence to
7 demonstrate that -- that the -- there was a great
8 deal of disease being caused by tobacco, and I
9 have studied that exchange.
20 MR. SWEDLOW: (Q) Let's switch gears
21 here for a second.
22 Do you need epidemiological data in order
23 to assess the relative harm of a potential new
24 product or a product change?
114
1 A. You -- it really depends. If you want
2 to ultimately know that something harms humans
3 then the -- ultimately need evidence of harming
4 humans.
5 However, if one is introducing a new
6 product or you're introducing some change in an
7 existing product, if you have evidence from other
8 fields - from toxicology, from -- from clinical
9 studies in which you demonstrate carcinogens or
10 the outtake of carcinogens or toxic substances in
11 humans, that kind of evidence you -- it is
12 inappropriate -- if you have evidence that the
13 product is not actually safer, it is
14 inappropriate to argue that you have to wait for
15 thirty or forty years for epidemiologic evidence
16 in order to act on that.
17 Q. And to depose the --
4 MR. SWEDLOW: Let me see if I can
5 connect it.
6 (Q) Let me ask you this question. How
7 does epidemiological evidence fit in with other
8 evidence relating to the relative harm of a
9 product like cigarettes?
7 MR. SWEDLOW: (Q) How are these other
8 fields of study that we just discussed incidental
9 to the study of epidemiology?
22 A. Perhaps the best way to think of it is
23 historically. Historically back in 1950 the five
24 epidemiologic studies came out the same year
117
1 showing a relationship between smoking and lung
2 cancer in men.
3 That epidemiologic evidence drew major
4 attention to the hazards of smoking and
5 stimulated just a vast number of other
6 epidemiologic studies. It also stimulated
7 further studies in animals, further attempts to
8 identify carcinogens in smoke, further efforts to
9 demonstrate that the carcinogens in smoke are
10 taken up by smokers and circulated to distant
11 organs. And so all of that evidence taken
12 together is what is referred to as the totality
13 of evidence by the Surgeon General's Reports in
14 concluding that smoking was harmful.
15 In this case, where you are talking about a
16 product that for which the epidemiologic evidence
17 has to wait for another thirty or forty years
18 following the introduction of a product, what --
19 what I think you're talking about is sort of
20 what's the role of epidemiology there.
21 Epidemiology would be great to have. It
22 would provide conclusive evidence of an effect in
23 humans, however, the waiting for thirty years to
24 see what happens has negative social consequences
118
1 that are generally considered by in this kind of
2 situation.
3 Q. When you refer to negative social
4 consequences, what do you mean by that?
5 A. What I mean is that in my experience of
6 working with occupational carcinogens and toxins
7 and other substances which are harmful, the
8 approach of policymakers is to try to act in a
9 timely fashion on information as it becomes
10 available.
11 Q. I want to switch gears again and talk
12 about your involvement in what we all now know is
13 Monograph 13.
14 What was your involvement in that?
15 A. I was a co-author on Chapter 4 which is
16 the chapter about the health effects that produce
17 yield cigarettes.
18 Q. If I can hand the witness a copy of
19 Monograph 13.
20 You look on the first page, the National
21 Institutes of Health is identified.
22 What is the National Institutes of Health?
23 A. National Institutes of Health are the
24 primary federal research agency that deals with
119
1 health largely based in Washington, and it's
2 comprised of many components, other institutes.
3 Q. And is the National Cancer Institute
4 one of those component institutes?
5 A. It is the oldest and largest of the
6 components.
7 Q. Can you please explain the process that
8 ultimately led to the publication of this
9 monograph?
10 A. The monograph was produced as part of
11 the National Cancer Institute's tobacco and
12 tobacco control monograph series, and the process
13 that they use is to convene authors to write the
14 individual chapters, and then what follows is
15 sort of the collaborative exchange among the
16 authors, and then a larger process a peer review
17 to ensure that the monograph is accurately
18 representing the state of the science.
19 Q. Did you participate in the writing of
20 any chapters of this monograph?
21 A. The first draft of the chapter that I
22 participated in was largely drafted by Dr. David
23 Burns.
24 Q. Let me interrupt. We haven't
120
1 identified the chapter that we're talking about.
2 So what Chapter is it that you participated in?
3 A. Chapter 4 which is the smoking lower
4 yield cigarettes and disease risk.
5 Q. And now I would like you to describe
6 the process that went into drafting of that
7 particular chapter like you were doing?
8 A. The -- Dr. David Burns who you see
9 listed there took the lead in drafting up the
10 first draft of one section that he included which
11 involved the comparisons of the two American
12 Cancer Society's studies that I described earlier
13 was -- was what taken from material that I had
14 written previously and then he circulated that to
15 the other authors for -- for comments and
16 changes.
17 Q. And let's talk about the other authors.
18 There is listed here you, and we know you.
19 Who is Jonathan Samet?
20 A. Jonathan Samet is the chairman of the
21 Department of Epidemiology at Johns Hopkins
22 University.
23 Q. And what was his role in the drafting
24 of the Chapter 4?
121
1 A. He is one of the co-authors, and so he
2 was involved in sort of the editing, comments,
3 and revisions.
4 Q. And Thomas Shanks and Jacquelin Major,
5 (phonetic spelling) do you understand what their
6 role was in the drafting of this chapter?
7 A. They both worked with Dr. David Burns,
8 and they have statistical and epidemiologic
9 expertise. So they did the analyses which were
10 new analyses in the chapter and also a pulling
11 together of a lot of the historical reviewed
12 material.
13 Q. You described the writing process for
14 Chapter 4 a collaborative writing process.
15 What do you mean by that?
16 A. Well, in this case what I mean is the
17 first draft was prepared by Dr. Burns, and then
18 he would circulate it around and get extensive
19 input from the rest of us on suggested revisions
20 and that would happen intermittently until we
21 will got to a product that was ready for peer
22 review.
23 Q. Can you explain what you mean by peer
24 review?
122
1 What is that process?
2 A. Peer review involves sending a product
3 or send a publication out to leaders in the field
4 in this case leaders in tobacco, epidemiology,
5 internationally and getting their feedback to
6 further improve the chapter.
7 Q. And generally who were the peer
8 reviewers of your chapter, Chapter 4 of Monograph
9 13?
10 A. They are listed in the beginning of the
11 monograph, and they are basically leaders in
12 tobacco epidemiology, internationally, for
13 example, Sir Richard Doll, Sir Richard Peto from
14 the UK and Dr. Gary Giovino who was the head of
15 the center for disease control office of smoking
16 in health epidemiology program.
17 Q. And as one of the authors of Chapter 4,
18 did you consider all of the comments you received
19 from peer reviewers?
20 A. Yes.
21 Q. Then what is the process when you
22 receive these comments to the final product of
23 what is now Chapter 4, how does that process
24 work?
123
1 A. Well, that -- that process consisted of
2 considering those comments. Just because someone
3 makes a comment it doesn't mean that it is
4 incorporated in the way this that the reviewer
5 suggested it and exactly the same way.
6 Basically there's a lot of exchange among
7 the co-authors, and in this case there was a
8 additional review process. The co-authors met in
9 Toronto and further discussed the -- the issues
10 in the chapter, and -- and there was further
11 circulating of the -- of the chapter to
12 epidemiologists within the National Cancer
13 Institute.
14 Q. You referred earlier to previously
15 unpublished statistical analysis that were
16 performed in part by Thomas Shanks and Jacqueline
17 Major.
18 Did you review those statistical analyses
19 prior to publication?
20 A. Yes.
21 Q. Are there any conclusions in Chapter 4
22 of Monograph 13 that are based solely upon those
23 statistical analyses?
24 A. No. The six conclusions in Chapter 4
124
1 are based on the weight of the evidence, all the
2 different kinds of evidence.
3 Q. And how does the statistical analyses
4 fit into the analytical framework then of Chapter
5 4?
6 A. Well, Chapter 4 has a many part, and is
7 to those additional analyses that were done by
8 Dr. Burns' groups are one of the parts and they
9 look, for example, at the relationship of the
10 nicotine machine-measured nicotine in cigarettes
11 to cigarettes per day, etc.
12 Q. You referred to the six conclusions in
13 Chapter 4 which we'll get to in a minute.
14 Would any of those six conclusions have
15 been different if these new statistical analyses
16 were not part of Chapter 4?
17 A. No. The conclusions are not dependent
18 on those new analyses.
19 Q. Let's look at one of the analyses.
20 CKT15984, pretty quick.
21 For the purposes of this analysis, in
22 Chapter 4, Dr. Thun, if we can blowup the tar
23 level key. That's good.
24 What are the tar levels indicated there,
125
1 and I'm not asking you to read them all but just
2 generally define what they are?
3 A. Sure. Well, the four tar levels that
4 you see were chosen because they represent the
5 kinds of cigarettes that were being smoked in the
6 one population which I mentioned were people
7 enrolled in 1959 and the median age was 55. So
8 those tar levels are much higher than the range
9 of tar levels that current products have.
10 Q. The lowest tar level here what I think
11 is considered the reverent is 18.0 and down.
12 Does -- does -- do these tar levels
13 distinguish between the current Marlboro Light,
14 Marlboro, Cambridge Light or Cambridge?
15 A. No, all four of those brands would be
16 in that less than eighteen category.
17 Q. In fact, do these tar levels that are
18 used for this figure 4-5 analyses correspond to
19 modern-day cigarettes as a relevant grouping of
20 tar level?
21 A. All of those tar levels are higher
22 particularly the top three are higher than the
23 usual current products.
24 Q. And what do you understand to be the
126
1 current machine-measured tar levels for Marlboro,
2 Marlboro Light, Cambridge, and Cambridge Light?
3 A. Well, currently Marlboro runs around
4 fifteen or sixteen milligrams of tar, and
5 Marlboro Light runs about five milligrams of tar
6 less -- over time the range in difference to the
7 light product and the regular product has been
8 between three or four and -- and six milligrams
9 of tar.
10 Q. When you say the range of difference,
11 are you talking about the machine-measured tar
12 level?
13 A. Yes. The machine-measured tar level in
14 a given year wasn't constant for these brands,
15 and so the difference varies very subtly.
16 Q. And what do you base your understanding
17 of the tar levels of the four products at issue
18 in this case on?
19 A. On the Federal Trade Commission
20 published measurements.
21 MS. BAUER: I'm sorry.
22 MR. SWEDLOW: (Q) Looking for the FTC
23 reports we just referred to. So just take me one
24 second.
127
1 Hand you a copy of what's going to be a
2 group exhibit.
3 If you could take these exhibits out of
4 that group exhibit folder there and describe to
5 the Court what's in there?
6 A. Well, these are the annual reports of
7 the machine-measured tar and nicotine content of
8 most of the varieties of cigarettes.
9 THE COURT: You want to identify that
10 for the -- by the yellow tag there?
11 MR. SWEDLOW: Enter a number on the
12 yellow tag?
13 A. Group A, oh, it's C -- supposed to be
14 numbers? CKTO12356.
15 MR. TILLERY: This would be -- this
16 would be Group 46, Your Honor.
17 THE COURT: Yeah, I want him to refer
18 to it.
19 MR. SWEDLOW: Would be Group 46, Steve.
20 (Q) These documents are covered by the
21 previous stipulation between the parties. I
22 would move for the admission of Group Exhibit 46
23 into evidence.
8 MR. SWEDLOW: Put up CKT900271.
9 (Q) Dr. Thun, does this generally
10 represent --
11 THE COURT: You focus in a little
12 better so that --
13 MR. LOMBARDI: We can see it on our
14 screen.
15 THE COURT: That's all right. As long
16 as they can see it. That's my concern.
17 MR. SWEDLOW: (Q) Dr. Thun, does this
18 graphical representation generally represent the
19 tar levels of Marlboro Lights, Marlboro Reds and
20 their variants over time?
21 A. Yes, it does.
22 Q. And the space in between the two lines
23 the purple, what does that represent?
24 A. Well, that represents the difference in
129
1 machine-measured tar level of the light versus
2 the regular.
3 What my earlier point was that through most
4 of the time both of those brands are below the
5 level eighteen milligrams that we saw in the
6 previous figure.
7 Q. So for the purposes of the analysis in
8 Chapter 4 or the vast majority of it, is there
9 any distinction drawn between a Marlboro Light
10 and a Marlboro Red?
11 A. They would both be in that lowest
12 category.
13 Q. Why is it that the tar grouping within
14 Chapter 4 and the analysis in Chapter 4 didn't
15 try to distinguish between what -- what we call a
16 modern-day light cigarette and a modern-day
17 regular cigarette?
18 A. Well, the analyses that you pointed to
19 were done in study one and that represented the
20 distribution of machine-measured tar the products
21 being smoked at the time. The products that
22 we're talking about came in after that study.
23 Q. And what was the purpose of the study
24 being conducted by the monograph, meaning was the
130
1 purpose to assess the difference between a
2 modern-day light cigarette and a modern-day
3 regular cigarette?
11 MR. SWEDLOW: (Q) What was the
12 specific purpose of the entire Monograph 13, and
13 what I mean by that was the purpose of the
14 Monograph 13 to assess the disease risk reduction
15 associated with lights compared to regulars, or
16 was there a larger purpose involved?
17 MR. LOMBARDI: Objection; leading.
18 THE COURT: Overruled.
19 A. Monograph 13 was looking at the effects
20 of all of the design changes in cigarettes that
21 occurred during most of the second half of the
22 twentieth century and their relationship to
23 disease risks. So it was covering the whole
24 range in tar from thirty-seven milligrams all the
131
1 way down to the lowest. It was not focusing on a
2 particular place in that gradient.
3 Q. I would like to discuss the different
4 kinds of epidemiological evidence that you
5 reviewed for the purposes of Chapter 4 of
6 Monograph 13 and for the purposes of your
7 testimony here today and obtain your insights
8 concerning the consequences of changes in
9 cigarettes and their relative risk reduction over
10 the past fifty years.
11 Did you consider cohort study comparison
12 of lung cancer in smokers over time?
13 A. Yes. We looked particularly within
14 large cohorts that had covered a long period of
15 time or comparisons of cohorts at discrete
16 periods of time.
17 Q. Now, let's define for everybody
18 including me what a cohort study is?
19 A. A cohort study is defined by assembling
20 a group of people in with whom you determine
21 their exposure, and then you follow them forward
22 and see how their disease occurrence relates to
23 the exposures.
24 And the principal thing is that you're
132
1 measuring the exposure before they become
2 diseased. So the two American Cancer Society
3 studies that I described to you are large cohort
4 studies.
5 Q. And I think you just did a little bit.
6 Can you identify briefly the strength and
7 weaknesses of such a study, meaning a cohort
8 study?
9 A. The principal strength is that because
10 the people haven't developed disease yet the
11 awareness of disease or the disease itself is not
12 influencing the way they're reporting their
13 exposure.
14 Q. Are there different kind of cohort
15 studies?
16 A. Well, you can do many different kinds
17 of analyses within cohort studies. One of the
18 sets of analyses that we did for Chapter 4 was
19 comparing lung cancer risk in the first American
20 Cancer Society cohort to the second American
21 Cancer Society cohort according to smoking
22 status.
23 Another approach that one can do like in
24 the British doctors' study is look at how the
133
1 relationship between smoking and lung cancer
2 changed over the forty year follow-up of that
3 cohort.
4 Q. As I understand your testimony
5 correctly, there are cohorts with long
6 follow-ups; that would be like the -- what did
7 you say, the British Physician Study?
8 A. Yes.
9 Q. And then there are -- are you capable
10 of comparing two different cohorts?
11 A. In the case of the two American Cancer
12 Society studies they -- they are comparable in
13 that they are very very similar populations.
14 They were enrolled by American Cancer Society
15 volunteers, and they have very similar
16 demographics.
17 And so you can make comparisons of what
18 happened to the relationship between smoking and
19 the diseases it caused in the first compared to
20 the second cohort.
21 Q. Did you also -- and do you also
22 consider case-control studies?
23 A. Definitely. That is a part of the
24 literature. Case-control studies identify
134
1 smoking history after people become a case.
2 Q. Back up. Give us a more rudimentary
3 definition of case-control studies to begin with?
4 A. A case-control study looks at the
5 exposure at the association between some exposure
6 and disease with a different design in which you
7 identify a group of cases and a group of controls
8 who you're going to compare them to, and you then
9 ask them about their exposure.
10 Q. And I assume there's strengths and
11 weaknesses associated with this form of study?
12 A. Yes, the principal weakness is that
13 their presence of their disease may affect the
14 recording of their exposure.
15 Q. Are there limitations or weaknesses
16 that cover both cohort studies and case-control
17 studies?
18 A. Particularly as concerns this issue,
19 there are important limitations.
20 For instance, all of these studies are in
21 the case of light of a different tar levels are
22 comparing disease risk in smokers who are smoking
23 different products, but they're not considering
24 the possibility that people who believe that a
135
1 product is reducing their risk may delay
2 cessation.
3 They're also not considering the
4 possibility that the marketing of products may
5 increase initiation of smoking, so thereby
6 increasing the pool of people who are smoking.
7 And the final thing that they don't
8 consider is the possibility that the level of
9 nicotine addiction, the nicotine requirements of
10 people may influence whether they are able to
11 switch or whether they do switch to a product
12 with lower machine-measured.
13 Q. What do you mean -- and I don't want to
14 go into addiction and get all of these
15 objections, but what do you mean by the level of
16 addictiveness when you say that?
17 A. If a person's nicotine requirements are
18 high, they may be less able to switch to a low
19 yield or a very low-yield product than in a
20 person whose nicotine requirements are less.
21 And, therefore, any disease associations
22 that you see may actually reflect the underlying
23 degree of nicotine addiction and the lifelong
24 smoking history rather than the difference in the
136
1 design of the product.
2 Q. Are you saying that the disease result
3 may not be correlated with the machine-measured
4 tar level because of this limitation?
5 A. I'm saying that the -- that the
6 association may actually represent a different
7 level of addiction in different smoking patterns
8 that you're not measuring rather than differences
9 in the hazard of the product.
10 Q. Did you also consider national cancer
11 rates by age and smoking patterns in your
12 analysis?
13 A. Yes, we did.
14 Q. And are there any strengths and/or
15 weaknesses to that form of analysis?
16 A. Well, the purpose of public health is
17 to reduce cancer occurrence in the whole
18 population, and so looking at national cancer
19 rates is a measure of the success of reducing
20 overall cancer rates.
21 The limitation is that in national rates
22 you can't distinguish who is smoking and who is
23 not smoking, and you can't directly take account
24 for the -- the percentage of people who are
137
1 smoking or the amount that they're smoking.
2 Q. Why did you look at all of these
3 different forms of epidemiological evidence in
4 doing your analysis?
5 A. We were -- we were trying to provide a
6 comprehensive analysis of the kinds of evidence
7 that were out there, and a comprehensive
8 synthesis of what that evidence did or didn't
9 tell us.
10 Q. And do -- does looking at all of these
11 different forms of evidence diminish or dilute
12 the specific limitations of any one particular
13 study or of any one particular form of study?
14 A. Yeah, these lines of evidence tend to
15 be complimentary, and so each line of evidence
16 has limitations, but in the aggregate the
17 information that they provide more information
18 than any line of evidence singly.
19 Q. I think we talked about this a little
20 bit before, but I want you to identify for me,
21 other demographic or behavioral characteristics
22 that can influence epidemiological data.
23 Do you understand what I mean by that?
24 A. In the case of studies of reduced tar
138
1 cigarettes, the -- the -- the one important
2 additional factor that cannot be measured well is
3 the degree of nicotine addiction that I mentioned
4 earlier. There are other factors.
5 More educated and more affluent people have
6 been more likely to switch than -- than less
7 educated and poor people. One can control for
8 that. There's always a possibility that
9 control's not complete.
10 Q. I know we talked generally about now
11 the categories of review for Chapter 4.
12 But specifically and if you could put up
13 CKT15969 I want to talk about what exactly was
14 reviewed in the context of chapters -- Chapter
15 4's analysis.
16 A. Table 1 lists the epidemiologic studies
17 of reduced-yield cigarettes in relation to lung
18 cancer. It's a long chapter, and it tried to
19 summarize sort of key issues about each study.
20 Q. If we could just scroll through each
21 page of this rather than pulling out our books.
22 MR. TILLERY: This is 47, Steve.
23 MR. SWEDLOW: (Q) Dr. Thun, I would
24 like you to flip through what I have handed you
139
1 which has been marked Group Exhibit 47.
2 Tell me what it is.
3 A. What you have handed me is the actual
4 articles that make up Table 1.
5 MR. SWEDLOW: I would like to move for
6 the admission, subject to limitation that you'll
7 need to look through those, Group Exhibit 47.
8 MR. LOMBARDI: And, Your Honor, on the
9 assumption that it is what counsel is represented
10 then I have no objection, but --
11 THE COURT: All right. Be admitted on
12 that basis.
13 MR. SWEDLOW: (Q) These documents that
14 are now in front of you, were all of these
15 documents considered in coming to the conclusions
16 not only that you arrived at with respect to
17 Chapter 4, but with respect to the opinions
18 you're offering here today?
19 A. Yes.
20 Q. Is there another place we can look --
21 well, let me ask it this way.
22 Does Table 4-1 represent the entire body of
23 literature that was reviewed with respect to
24 Chapter 4?
140
1 A. Well, there were some other papers that
2 are discussed in the text that were not in the
3 table, but -- but that's correct.
4 Q. Let me -- CKT16039. Now, we're looking
5 at the multi-page reference.
6 Are these the other items that were
7 considered but not listed in the table that you
8 just referred to?
9 A. I can't read that very well. That
10 looks like the citations for the chapter as a
11 whole.
12 What I was saying is that there were some
13 other epidemiologic studies that were discussed
14 in the text and -- and are not in the table. But
15 they're discussed rather extensively in the text.
16 Q. Handing you what has been marked as
17 Plaintiff's Group Exhibit 48, and I would like
18 you to take a look at those and identify them for
19 the record?
20 A. Well, these are other references in --
21 in -- in the chapter that refer to other aspects
22 besides lung cancer that refer to other diseases,
23 there are review papers, etc.
24 Q. Were these documents considered in your
141
1 analysis in arriving at your conclusions for
2 Chapter 4?
3 A. Yes.
4 MR. SWEDLOW: I would like to move for
5 the admission of Group Exhibit 48 that I will
6 provide counsel a chance to review those.
7 MR. LOMBARDI: And it's same thing,
8 Judge. I don't have any --
9 THE COURT: Same ruling.
10 MR. SWEDLOW: Put up CKT0 --
11 THE COURT: I'm sorry?
12 They're admitted subject to any of the
13 specific objection.
14 MR. SWEDLOW: CKTO16033.
15 (Q) What -- this may get tedious, but I
16 would like to go through the conclusions we
17 referred to earlier.
18 First of all, what is the general
19 conclusion of Chapter 4, the Monograph 13?
20 A. The general conclusion is that after
21 reviewing all of this material, we did not find
22 convincing evidence that there was an important
23 continuation in the risk from the lower-yield
24 cigarettes than from higher-yield cigarettes.
142
1 Q. I'm going to read these conclusions
2 into the record, and then ask you if you agree
3 with these conclusions based upon the information
4 you have reviewed.
5 First conclusion is "changes in cigarette
6 design and manufacturing over the last fifty
7 years have substantially lowered the sales
8 weighted machine-measured tar and nicotine yields
9 of cigarettes smoked in the United States".
10 Do you agree with that conclusion?
11 A. Yes.
12 Q. Second is "cigarettes with low
13 machine-measured yields by the FTC method are
14 designed to allow compensatory smoking behaviors
15 that enable a smoker to derive a wide range of
16 tar and nicotine yields from the same brand,
17 offsetting much of the theoretical benefit of a
18 reduced-yield cigarette".
19 Do you agree with that conclusion?
20 A. Yes.
21 Q. The third one is "existing disease risk
22 data do not support making a recommendation that
23 smokers switch cigarette brands. The
24 recommendation that individuals who cannot stop
143
1 smoking should switch to low-yield cigarettes can
2 cause harm if it misleads smokers to postpone
3 serious efforts at cessation".
4 Do you agree with that conclusion?
5 A. Yes.
6 Q. Fourth is "the widespread adoption of
7 lower-yield cigarettes by smokers in the United
8 States has not prevented the sustained increase
9 in lung cancer among older smokers".
10 Do you agree with that?
11 A. Yes.
12 Q. "Epidemiological studies have not
13 consistently found lesser risk of diseases, other
14 than lung cancer, among smokers of reduced-yield
15 cigarettes. Some studies have found lesser risks
16 of lung cancer among smokers of reduced-yield
17 cigarettes. Some or all of this reduction in
18 lung cancer risk may reflect differing
19 characteristics of smokers of reduced-yield
20 compared to higher-yield cigarettes".
21 Do you agree with that?
22 A. Yes.
23 Q. I just want to break that down. That
24 last part is what we were referring to earlier.
144
1 Is that the level of addiction point?
2 A. Yes.
3 Q. And the first part of that statement is
4 that is a conclusion related to diseases other
5 than lung cancer, is that correct?
6 A. Yes.
7 Q. And, well, we'll get into the other
8 diseases in a little bit.
9 The final conclusion, and I think you have
10 already summarized this for us, is "there is no
11 convincing evidence that changes in cigarette
12 design between 1950 and the mid-1980s have
13 resulted in an important decrease in the disease
14 burden caused by cigarette use either for smokers
15 as a group or for the whole population".
16 Do you agree with that conclusion?
17 A. Yes.
18 Q. We can go to 15889.
19 This is page 2, Figure 1-1 of the
20 monograph, and what I'm focussing on is the
21 conclusion where you say that there's no
22 convincing evidence changes in cigarette design
23 between 50's and the mid-80's resulted in
24 important decrease in the disease burden.
145
1 If we could blow up that chart. Starting
2 in -- I believe you said this analysis was
3 covering a fifty year period, is that correct?
4 Starting in approximately 1955, '56 what was the
5 sales weight tar average for cigarettes in the
6 United States?
7 A. It was above thirty-five as high as
8 thirty-seven milligrams tar.
9 Q. And then by the mid-'80s -- well, let's
10 move back a little bit just to be conservative.
11 By the mid-'70s what was the
12 machine-measured tar yield sales weighted
13 average, sorry?
14 A. Something about eighteen milligrams.
15 Q. What is the predominant design change
16 that reduced machine-measured tar yields from
17 approximately thirty-seven to approximately
18 seventeen or eighteen?
19 A. That major reduction is largely from
20 the introduction of filters.
21 Q. And what do you understand to be the
22 design distinction at issue between a modern-day
23 light cigarette and a modern-day light or more
24 specifically a Marlboro and Marlboro Light as
146
1 well as a Cambridge and Cambridge Light?
2 A. We're talking not about filters or
3 nonfilters, talking about the degree of
4 ventilation of the cigarette.
5 Q. Okay. If we could turn to Figure
6 CKTO15980 and blow up that chart.
7 We just saw that the sales weighted average
8 decreased over time, and I guess I'll just ask
9 you this way.
10 How did these market share of filter versus
11 nonfilter impact the other chart that we were
12 just looking at?
13 A. Sure. The dashed line that's the upper
14 end on up above on the right is the market share
15 of filter cigarettes, and if you go back you can
16 see that -- that there were some filters before
17 1955, but that introduction of filters really
18 took off and -- and reached close to hundred
19 percent market share by the end of that graph.
20 And the reduction -- the main reduction in
21 machine-measured tar that occurred before the
22 mid-'70's was largely the consequence of
23 introducing filters.
24 Q. Now, I want to turn back. I think we
147
1 have covered this ad nauseam now, but your
2 opinions in this case are they based in part upon
3 all the documentary evidence that we have just
4 offered onto the record here?
5 A. They're based in part but not -- also
6 other things that I consider.
7 Q. Are your opinions in this case based
8 upon your analysis of CPS-I and CPS-II?
9 A. Yes.
10 Q. What specifically are your
11 responsibilities or have been your
12 responsibilities with respect to CPS-I and CPS-II
13 for the past fourteen years?
14 A. Well, I'm principally responsible for
15 them.
16 Q. Is your opinion in this case also based
17 upon any independent work or investigation you
18 have done with respect to epidemiology?
19 A. It is definitely based on my
20 epidemiologic experience.
21 Q. In your opinion, based upon every
22 epidemiological study you have ever seen, all of
23 the analysis you conducted for the purposes of
24 Monograph 13, and all of your experience in
148
1 epidemiology for the past twenty-five years, does
2 the machine-measured tar difference between
3 Marlboro Lights and Marlboro as well as
4 Cambridge Lights and Cambridge lead to any
5 disease reduction whatsoever among those
6 comparative smoking populations?
7 A. No, there is no evidence for that at
8 all.
9 Q. To -- to this point in our discussion
10 we have been talking generally about all of the
11 diseases associated with smoking as a group.
12 Now I would like you to identify for the
13 Court and the use of demonstrative for this the
14 different kinds of diseases caused by smoking.
15 But first, approximately how many deaths in
16 the United States each year are caused by
17 smoking?
18 A. It's approximately four hundred forty
19 thousand deaths each year.
20 Q. Can you provide us with a frame of
21 reference, and add a little framework for how
22 many deaths that is?
23 MR. LOMBARDI: Your Honor, I object. I
24 think I know where this is going. Four hundred
149
1 forty thousand deaths is his testimony.
2 THE COURT: To me, you know, that's a
3 lot of people dying. But if there is any other
4 function of that you want to get into, go ahead.
5 MR. SWEDLOW: (Q) Do you know
6 approximately how many deaths in Illinois are
7 caused by smoking each year?
8 A. Not off the top of my head. I'm sure
9 that's readily available information.
10 Q. If we could go to CKT900238. I would
11 like to first focus on the cancers caused by
12 cigarette smoking.
13 I think we have already discussed lung
14 cancer so that would be the first cancer caused
15 by cigarette smoking.
16 Is mouth cancer caused by cigarette
17 smoking?
18 A. Yes, cancer of all the different parts
19 of the mouth.
20 Q. How about throat cancer?
21 A. Yes.
22 Q. How about nasal cavity cancer?
23 A. Yes.
24 Q. What about larynx cancer?
150
1 A. Yes.
2 Q. What is the larynx?
3 A. Voice box.
4 Q. How about stomach cancer?
5 A. Yes.
6 Q. Liver cancer?
7 A. Yes.
8 Q. Pancreas cancer?
9 A. Yes.
10 Q. Bladder cancer?
11 A. Yes.
12 Q. Myeloid leukemia?
13 A. Yes.
14 Q. Cervical cancer?
15 A. Yes.
16 Q. With respect to all of the cancers that
17 we have just identified, they're listed up there,
18 in your opinion based upon everything you know,
19 everything you have seen, and everything you have
20 reviewed relating to cigarette smoking
21 epidemiology, is there any disease risk reduction
22 whatsoever for these cancers associated with
23 light cigarettes, the ones at issue in this case,
24 and comparing them to their regular counterparts?
151
1 A. There is no evidence on that part
2 whatever.
3 Q. Also like to discuss other diseases
4 caused by cigarette smoking.
5 Is -- is the group of diseases called
6 cardiovascular diseases, are those caused by
7 smoking?
8 A. Yes.
9 Q. I'm going to ask you the same question
10 again.
11 With respect to cardiovascular diseases
12 specifically, in your opinion based upon
13 everything you know, everything you seen and
14 everything you have reviewed relating to
15 cigarette smoking epidemiology, is there any
16 disease risk reduction whatsoever for
17 cardiovascular diseases taken as a whole
18 associated with the light cigarettes at issue in
19 this case compared to the regular counterparts?
20 A. There is no evidence whatever that
21 there is a reduction.
22 Q. Do cigarettes -- does cigarette smoking
23 cause chronic respiratory diseases?
24 A. Yes.
152
1 Q. I'm going to ask you the same question
2 again.
3 With respect to chronic respiratory
4 diseases, in your opinion based upon everything
5 you know, everything you have seen, and
6 everything you have reviewed related to cigarette
7 smoking epidemiology, is there any disease risk
8 reduction for chronic respiratory diseases
9 associated with the light cigarettes at issue in
10 this case compared to the regular counterparts?
11 A. No, there is no evidence whatever.
12 Q. Have -- put up CKT150300.
13 Have you written any other peer review
14 publications addressing the health impact of
15 reduced-yield cigarettes?
16 A. Yes. The article that you're
17 displaying here was one that I wrote with David
18 Burns at the same time it's -- we were developing
19 Chapter 4 in the monograph.
20 Q. Did this article arrive at the same
21 conclusion as Chapter 4?
22 A. Well, it doesn't state the conclusions
23 in the same way, but it -- it does.
24 Q. Where was this article published?
153
1 A. Tobacco control.
2 Q. Does the tobacco control have a peer
3 review process?
4 A. Yes.
5 Q. Is it a different peer review process
6 than the Monograph 13 peer review process?
7 A. It's not as extensive.
8 Q. Were the peer reviewers different than
9 they were for the Monograph 13?
10 A. The -- you're blinded as to who the
11 peer reviewers are.
12 Q. So there were peer reviewers, but you
13 don't know who they were?
14 A. Right.
15 Q. Was the same question analyzed in this
16 article as was analyzed in Chapter 4?
17 What I mean by that is was this an analysis
18 of design changes over the past fifty years and
19 their association with potentially reduced risk?
20 A. Yes.
21 Q. I think we have talked about this. We
22 have touched on this, but are there other impacts
23 at the existence of light cigarettes marked as
24 lower tar or lights can have upon disease risk
154
1 that the epidemiological evidence has no way to
2 capture?
3 A. The three that I mentioned which are
4 the biggest concern in public health are that the
5 false perception that one is avoiding risk may
6 cause some smokers to delay cessation, delay
7 cessation is proven to reduce risk from all of
8 these diseases, and the smokers would be choosing
9 unproven approach as opposed to a proven one, and
10 that might also affect initiation particularly
11 when you look over the full gradient from the
12 thirty-five milligrams of tar, thirty-seven
13 milligrams down to the present certainly the
14 advent of more palatable cigarettes has increased
15 the potential to market to women and children.
16 Q. We have already discussed the fact that
17 the Monograph 13, Chapter 4, and the article
18 cited therein do not specifically distinguish
19 within tar categories between a modern-day light
20 and a modern-day regular, but my question to you
21 is are you aware of published studies that have
22 distinguished the tar category known as -- well
23 the tar category that includes a Marlboro Light
24 as opposed to the tar category that includes a
155
1 Marlboro regular?
2 A. All of the literature really at the
3 time of the monograph was dealing with mostly
4 higher tar. There's extremely limited evidence
5 in the tar ranges that we're talking about.
6 Q. Can you put up CKT900197?
7 Are you familiar with this article that is
8 now being displayed?
9 A. Yes.
10 Q. In this article -- well, first of all,
11 we see the author Mark Woodward, Ph.D.
12 In this article if we can lower that,
13 turning to the third page of the article if we
14 can, I want you to identify for us the tar
15 category groupings in this article.
16 We may have to go back -- let me give you a
17 CKT number. The next page. No, no. It's
18 CKT900198.
19 Paragraph on the upper right side, top
20 paragraph.
21 Can you identify for us the tar categorical
22 groupings identified in this article?
23 A. Yes. This -- since this is a current
24 article, the categories of machine-measured tar
156
1 are much lower than they were in the Cancer
2 Prevention Study I we talked about earlier. You
3 can see that the -- the low tar is less than ten
4 milligrams of machine-measured tar. The
5 low/middle tar is just under fifteen; the middle
6 tar fifteen just under eighteen, and the high tar
7 is greater than eighteen.
8 Q. And which category encompasses for the
9 majority or all of the period that Marlboro
10 Lights were on sale in this country, which
11 category encompasses Marlboro Lights?
12 MR. LOMBARDI: And, Your Honor, I --
13 maybe I missed it, but I didn't hear any
14 description of the time period at which this
15 article came out.
16 I believe it's 2001 article, is that
17 correct?
2 MR. SWEDLOW: (Q) Can we go back to
3 the first page?
4 Do you recall when this article was
5 published?
6 A. If you show me the abstract of -- the
7 article was published in 2001.
8 Q. Can we blow up the "method" section?
9 It's the second -- there you go.
10 A. It is a cohort study in Scotland and
11 enrolled just under thirty-five hundred smokers,
12 and it followed them for a period of thirteen
13 years.
9 (Q) Let me do that through a --
10 Do epidemiological studies generally focus
11 on brand specific population comparisons?
12 A. No. They -- the epidemiologic studies
13 of the issue of reduced-yield cigarettes have
14 focused either on filter versus nonfilter or
15 machine-measured tar yield.
16 Q. And this study as I understand it
17 compares machine-measured tar yields relevant to
18 the products in this case, is that correct?
19 A. Yes. The -- the levels of
20 machine-measured tar in this study are more
21 relevant to the products in this case than were
22 the CPS-I levels.
23 Q. And does the fact that this article was
24 published in 2001 have any impact upon its
159
1 relevance to the associate disease risk with
2 respect to these machine-measured tar yields over
3 the course of time?
13 MR. SWEDLOW: (Q) Does this article
14 have relevance to the tar categories at issue in
15 our litigation?
16 A. It does. It's the one article that
17 addresses the risks of associated with smoking
18 cigarettes of tar levels that are comparable to
19 the ones in this case.
20 Q. If you could turn to CKT900200 and blow
21 up Table 2.
22 What does Table 2 demonstrate, reflecting,
23 or exhibiting?
24 A. Well, what Table 2 is doing is showing
160
1 the percentage of smokers in each of these three
2 tar groups who died during the follow-up period
3 from the diseases listed across the top.
4 And -- and -- and so the -- the pattern
5 that you see in this analysis is not even
6 controlled for age. The age distribution of the
7 three tar groups was almost identical.
8 What you see is that the -- the low tar
9 group, the people with a cigarette
10 machine-measured yield of less than ten, had a
11 smaller percentage die during the follow-up than
12 the low/middle tar which is where the products
13 that are at issue in this case are or the
14 middle/high tar. The latter two categories are
15 essentially similar.
16 Q. The tar category that contains Marlboro
17 Lights, I'll call it the Marlboro Lights tar
18 category, what is the percentage of death from
19 all causes?
20 A. It says sixteen percent.
21 Q. And what with respect to the tar
22 category that covers Marlboro Reds or the
23 Marlboro Red tar category, what is the percentage
24 of death from all causes?
161
1 A. It says sixteen percent.
2 Q. And sixteen percent is therefore the
3 same number for both the Marlboro Lights tar
4 category and the Marlboro Reds tar category?
5 A. Yes.
6 Q. If we could go to Table 3.
7 You were speaking earlier about age
8 adjustment.
9 Does this table adjust for age?
10 A. This table is in the three columns.
11 The first column there is adjusted for age and
12 sex. The second is adjusted for a few more
13 variables, and then the third column is adjusted
14 for a whole bunch of things which are listed down
15 in the footnote.
16 Q. Using the most adjusted category
17 comparing the tar category that is the Marlboro
18 Light category to the tar category that is the
19 Marlboro Red tar category, which in every single
20 one of these causes, which category has a higher
21 numerically higher hazard ratio?
22 A. Well, numerically the Marlboro Light
23 category is higher than the Marlboro Red, but
24 because of the confidence it enrolls these
162
1 numbers are essentially the same number.
2 There is no difference between them.
3 Q. So your conclusion based on this data
4 would be what, with respect to the hazard ratio
5 for a Marlboro Light tar category compared to a
6 Marlboro Red tar category?
7 A. It would be in this study in Scotland
8 there was no evidence of a lower risk of -- of
9 more death in the category that is comparable to
10 Marlboro Light than to Marlboro -- the one with
11 Marlboro Red.
12 Q. I would like to change gears to the
13 last topic we will discuss today.
14 First, can you tell us what are the four
15 major histological types of lung cancer?
16 A. There's squamous cell lung cancer,
17 adenocarcinoma, small cell, and large cell.
18 Q. Can you put up 900235?
19 Are there different cells in the body
20 that generally give rise to these different kinds
21 of cancers?
22 A. Yes.
23 Q. Can you explain first with respect to
24 adenocarcinomas, what cells generally give rise
163
1 to in the lung adenocarcinoma?
2 A. Well, the cells that give rise to
3 adenocarcinoma are further out in the smaller
4 airways and in the periphery of the lung than the
5 cells that give rise to either squamous cell
6 carcinoma or to small cell carcinoma which tend
7 to be the large central airways.
8 Q. And has there been a trend with respect
9 to the incidence rate of adenocarcinoma?
10 A. This is a very large increase in
11 incidence of adenocarcinoma both in this country,
12 Canada, many of the countries of Europe, Asia,
13 Australia, worldwide.
14 Q. When you say a large increase, can you
15 quantify that for us?
16 A. Using the Connecticut Tumor Registry
17 dated doing back to 1950, there's been about a
18 tenfold increase in the rate of the men and about
19 a seventeen-fold increase in the rate of women.
20 Q. Why do you say use the Connecticut
21 Tumor Registry?
22 A. Because it goes back further than the
23 National Cancer Institute's tumor program, the
24 Serra (s.i.c.) registry which begins in 1973.
164
1 Q. Have you researched and published
2 anything on this adenocarcinoma issue before your
3 involvement in this case?
4 A. Yes.
5 Q. Can we put up 900190?
6 Tell us what we're looking at now?
7 A. This is an article in the Journal of
8 National Cancer Institute that I and co-authors
9 published in 1997.
10 Q. Can we enlarge the first part of the
11 background part, the first couple of sentences?
12 It says here that the "adenocarcinoma of
13 the lung once considered minimally related to
14 cigarette smoking has become the most common type
15 of lung cancer in the United States".
16 Was that the focus of the study that you
17 summarized in this article?
18 A. Yes, it was to look at why that
19 occurred.
20 Q. Okay. Now, if we could go back to the
21 -- no. Where we just were.
22 The last at the bottom of the first column
23 there's a conclusion and as soon as you can blow
24 that up and read it.
165
1 Can you read the conclusion?
2 A. Sure. What we concluded from the study
3 was "the increase in lung adenocarcinoma since
4 the 1950s is more consistent with changes in
5 smoking behavior and cigarette design than with
6 diagnostic advances".
7 Q. I'm going to -- so that we don't have
8 to try to read off the board, I'm going to hand
9 you a copy of your article. I think we're on
10 Exhibit 49 now.
11 MR. SWEDLOW: For the record what I
12 have handed you is marked as Exhibit 49, a copy
13 of your article on adenocarcinoma. And move for
14 the admission of Plaintiff's Exhibit 49.
15 THE COURT: Any objection?
16 MR. LOMBARDI: No objection.
17 THE COURT: Be admitted.
18 MR. SWEDLOW: (Q) In the conclusion
19 here, you say that the rise in adenocarcinoma is
20 consistent with changes in smoking behavior and
21 cigarette design than with diagnostic advances.
22 Specifically what are you talking about
23 with respect to changes in smoking behavior and
24 cigarette design?
166
1 A. Right, the -- the two changes that were
2 of interest the one was the introduction of
3 filters and cigarettes with reduced nicotine
4 yield that would cause smokers to inhale more
5 deeply such that the carcinogens in the smoke
6 could get further out in the periphery to the
7 lung to the cells that give rise to the
8 adenocarcinoma than was the case back with
9 higher-yield cigarettes.
10 Q. If we could go back to 900237 we can
11 illustrate that point.
12 Can you describe what you just said in
13 using this as a demonstrative?
14 A. Sure. What this mannequin shows on the
15 left-hand side a smoker inhaling a cigarette with
16 higher nicotine delivery needs to take in smaller
17 puff volume and that exposes the cells of along
18 the major airways and central lung to the
19 carcinogens, but a person who smokes a cigarette
20 with lower nicotine delivery needs to inhale more
21 deeply and that brings the carcinogens out to the
22 periphery of the lung where adenocarcinomas
23 arise.
24 And what that orange line shows on the
167
1 right is the zone of occurrence of typically for
2 a pulmonary adenocarcinoma.
3 Q. In your opinion based upon everything
4 you have seen, written, and know, does the
5 decrease in machine-measured nicotine yield lead
6 to an increase in adenocarcinoma incidence?
7 A. This study doesn't distinguish which of
8 the changes in cigarette design account for the
9 rise in adenocarcinoma, but the -- it does two
10 things.
11 One is it shows that the rise in
12 adenocarcinoma is -- fits much more closely in
13 its temporal pattern with cigarettes than with
14 anything else. And it shows that the association
15 between cigarette smoking and adenocarcinoma got
16 very much stronger from the 1950s to the -- to
17 the 1980s and -- and implicates those two -- two
18 changes in cigarette design.
19 One is the reductions in nicotine yield and
20 deeper inhalation, and the second was the
21 introduction of reconstitute tobacco which has
22 stems in it which when burned release tobacco
23 specific N-nitrosamines which in animals when you
24 inject them can systemically cause adenocarcinoma
168
1 of the lung.
2 Q. And in your opinion is the dramatic
3 increase in adenocarcinomas explained
4 predominantly by diagnostic changes or by changes
5 in cigarette design?
6 A. The patterns were far more consistent
7 with changes in cigarette design than with
8 diagnostic changes. If they were explained by
9 diagnostic changes what you would see is when a
10 new technology was introduced you would have a
11 sudden increase in the incidence rate, the
12 recognition of the disease at all ages.
13 Q. Explain for us what we're talking about
14 when we say diagnostic changes?
15 A. Sure. Because adenocarcinomas are
16 further out in the lung, several technologies
17 might have made it easier for doctors to diagnose
18 adenocarcinoma without surgery -- open chest
19 surgery.
20 One was the invention of flexible
21 bronchoscopy, and the second was the invention of
22 thin needle aspiration where you put a needle in
23 from the outside of the chest and you thereby
24 avoid an operation.
169
1 And the third was some changes in -- in
2 stains, and if those had been the explanation for
3 the increase in adenocarcinoma then when the new
4 technology was introduced one would have seen
5 shortly after that a rise in incidence at every
6 age, and that's not the pattern we saw.
7 Q. Was there a -- well, let's go to 1 --
8 excuse me, 900193.
9 And I'll ask you as we do that, is there a
10 charge in your article that demonstrates the
11 point you were just making?
12 A. Yes, the top one.
13 Q. Open up that top one. And now just to
14 be clear here, is it your opinion that diagnostic
15 changes had no impact on the level of
16 adenocarcinoma?
17 A. Not at all. It's just that they were
18 not the major factors causing the increase.
19 Q. And if you can explain again with this
20 chart the way that you have determined that they
21 were not the major reason for increase?
22 A. Sure. Well, this is plotting the
23 incidence rate of adenocarcinoma of the lung in
24 Connecticut - men on the left, women on the
170
1 right. And what each of these lines represents
2 are people who are born within a -- a narrow time
3 window, so in essence represent generations of
4 birth cohorts.
5 And what you see as the lines go up is that
6 people who were born progressively later during
7 the century and therefore when they passed
8 through their adolescent years were -- had sort
9 of lifetime exposure to filter-tipped cigarettes
10 had higher risk of adenocarcinoma.
11 This generational pattern exactly what you
12 see always with smoking because smoking behaviors
13 are largely fixed in adolescence and they're not
14 consistent with the introduction of new
15 diagnostic tests.
16 Q. Thank you.
17 Is it -- for a housekeeping matter I forgot
18 to mark the Woodward documents we were discussing
19 so I'll give a copy to you.
20 This is Plaintiff's Exhibit Number 50,
21 Woodward article.
22 Now, this is just a little bit disjointed,
23 but I would like to move for admission into
24 evidence of Plaintiff's Exhibit Number 50.
171
1 MR. LOMBARDI: This was the Scottish
2 study, Judge, and I save my objections to the
3 testimony.
4 THE COURT: All right, subject to -- to
5 that, it'll be -- it'll be received into
6 evidence.
7 MR. SWEDLOW: (Q) Let me back up to
8 the adenocarcinomas. Sorry for the break there.
9 A. Uh-huh.
10 Q. Is it your opinion that all other
11 things being equal, a cigarette like Marlboro
12 Lights with increased ventilation and thereby a
13 decreased machine-measured nicotine yield would
14 contribute to the increase in adenocarcinomas as
15 compared to an identical cigarette with lower
16 ventilation and therefore a higher
17 machine-measured nicotine yield?
3 MR. SWEDLOW: Okay.
4 (Q) What if we had a cigarette, a -- two
5 cigarettes with identical tobacco blends. The
6 only difference between these two cigarettes was
7 that Cigarette A had higher ventilation. Let's
8 say twenty-five percent ventilation.
9 THE COURT: Let me interrupt you. And
10 you may -- you could specify particular of the
11 Marlboro and the cigarette question.
12 MR. SWEDLOW: Okay.
13 (Q) If Marlboro Lights has the same blend
14 in a lower machine-measured nicotine yield as
15 compared to Marlboro Reds, does the increased
16 prevalence of a Marlboro Light as compared to
17 Marlboro Reds contribute to the increased
18 incidence of adenocarcinomas?
19 A. Well, these brands would have been
20 among the brands that contributed to deeper
21 inhalation, greater exposure of peripheral lung
22 tissues to carcinogens and -- and therefore it
23 would have been a likely contributory factor.
24 Q. So it's your opinion that the increased
173
1 prevalence of Marlboro Lights as compared to
2 Marlboro Reds was a contributory factor to the
3 increased incidence of adenocarcinomas?
4 MR. LOMBARDI: Objection, foundation
5 and leading.
6 THE COURT: Why don't you --
7 MR. SWEDLOW: What I think the
8 beginning --
9 THE COURT: The leading is all right.
10 The -- why don't you ask for a degree of medical
11 certainty as a basis.
12 MR. SWEDLOW: (Q) Is it your opinion
13 based upon a reasonable degree of medical and
14 scientific certainty, that the decreased
15 machine-measured tar yield of a Marlboro Light --
16 Marlboro Lights as compared to a Marlboro Reds
17 that that phenomenon contributes to the increased
18 incidence rate of adenocarcinomas?
19 MR. LOMBARDI: It's the same objection,
20 Your Honor.
21 THE COURT: Overruled.
22 A. It's my opinion that -- that this shift
23 in cigarette design which involved these brands
24 and involved other brands was a major contributor
174
1 to the rise in adenocarcinoma.
2 MR. SWEDLOW: Just one housekeeping
3 matter.
4 I want to move for admission of the 2001
5 article written by Dr. Thun which I also forgot
6 to submit, and this would be Plaintiff's Exhibit
7 51 and so that I have no more questions.
8 MR. LOMBARDI: And no objection to this
9 document, Your Honor.
10 THE COURT: Be admitted.
11 And then you're done with this witness?
12 MR. SWEDLOW: No more questions.
13 THE COURT: Okay, let's take -- let's
14 just take a ten minute recess. We'll go until
15 12:00, and then we'll take lunch from 12:00 to
16 12:30.
17 (Whereupon, a brief
18 recess was taken
19 at this time.)
20 -- -- --
18 THE COURT: All right, you may
19 cross-examine the witness.
20 MR. LOMBARDI: Thank you, Your Honor.
21 CROSS EXAMINATION
_________________
22 By Mr. Lombardi
23 MR. LOMBARDI: (Q) Good morning. I
24 think it's still morning.
177
1 Dr. Thun, we haven't met. My name is
2 George Lombardi.
3 A. Hello.
4 Q. Dr. Thun, Monograph 13 came out in
5 November of 2001, is that correct?
6 A. I don't know the exact date.
7 Q. Sound about right though?
8 A. Yes.
9 Q. Okay, and when Monograph 13 came out or
10 Monograph 13 itself, you consider a significant
11 publication in epidemiology in low-tar cigarettes
12 generally, isn't that right?
13 A. It was the first broad synthesis of all
14 of the information at the time.
15 Q. Okay. So it was the first broad
16 synthesis first publication to bring everything
17 together and do an analysis, is that right?
18 A. Correct.
19 Q. And that had not been done before,
20 is that right?
21 A. Well, there had been many reviews by
22 individual authors.
23 Q. I'm talking about the broad synthesis
24 though, the broad synthesis had never been done
178
1 before, is that right?
2 A. Correct.
3 Q. And in the monograph, the conclusion in
4 the monograph that you talked about that states
5 that "there is no convincing evidence that
6 changes in cigarette design between 1950 and the
7 mid-1980s have resulted in an important decrease
8 in the disease burden caused by cigarette use";
9 you remember that -- that conclusion?
10 A. Yes.
11 Q. That was the first time that the United
12 States government had stated that conclusion in a
13 document, is that right?
14 A. To my knowledge.
15 Q. Now, going back in time, you are aware
16 that different conclusions had been reached about
17 tar and nicotine over the past thirty, forty
18 years; is that right?
19 A. Correct, different statements.
20 Q. Okay. And you are with the American
21 Cancer Society?
22 A. Correct.
23 Q. Now, you're aware that the American
24 Cancer Society had for years taken the position
179
1 that lowering tar and nicotine going to a
2 lower-yield cigarette was a good thing for
3 smokers to do if they weren't going to quit?
4 A. I would qualify that by saying that it
5 was not a formal position of the American Cancer
6 Society, and I'd also say that the catch that's
7 all been if they were not going to quit.
8 Q. Right. Just to make sure I don't think
9 I got a yes or no at the beginning of your
10 answer. So I just want to make sure the record
11 is clear.
12 It was the American Cancer Society over the
13 course of that period of time, meaning the
14 sixties through the nineties, did say lower in
15 tar and nicotine yields in your cigarette was a
16 good thing if you weren't going to quit?
5 A. The last time that facts and figures
6 makes that reference is not the mid-'90s. As you
7 say it's 1989.
8 Q. Okay, but so is the answer, yes, that
9 the American Cancer Society did make that
10 recommendation over the course of the sixties,
11 seventies, and eighties?
12 A. Well, I qualify it to say publications
13 from the American Cancer Society. There was no
14 official policy of the American Cancer Society.
15 Q. Is that a yes, sir?
16 MR. SWEDLOW: I'm going to object. He
17 doesn't have to give a yes or no answer.
18 THE COURT: I'll sustain the objection.
19 He indicated in which capacity it was done.
20 MR. LOMBARDI: Okay. I understand,
21 Your Honor.
22 (Q) Are you aware, Dr. Thun, that the
23 American Cancer Society published lists of tar
24 and nicotine yields of cigarettes under the FTC
181
1 test method?
2 A. When I was deposed, the lawyer who was
3 interrogating me from Philip Morris showed me
4 such --
5 MR. LOMBARDI: Your Honor, I move --
6 A. Showed me such a list, but I don't when
7 it was from.
8 Q. Are you aware that the American Cancer
9 Society published lists of tar and nicotine
10 yields of cigarettes?
12 MR. LOMBARDI: (Q) Did they publish
13 these lists?
14 A. Well, what I'm saying is that the
15 Philip Morris lawyer showed me an exhibit but
16 didn't tell me anything really about the source
17 when it was. So I don't know the -- the extent
18 to which these quote "lists" were published. I
19 have seen one piece of paper, and I have not been
20 told where it came from.
21 Q. Did it indicate that it came from the
22 American Cancer Society on the face of the paper?
23 A. Yes, it did.
24 Q. Okay.
183
1 A. I would like to also qualify --
6 MR. LOMBARDI: Okay. Well, Your Honor,
7 then I'll just ask one -- one final question on
8 this.
9 (Q) You have no reason to deny that the
10 American Cancer Society published lists of FTC
11 tar nicotine levels for cigarettes for the public
12 to look at it, do you?
13 A. I have no reason to deny that.
14 Q. And you have no reason to deny that the
15 American Cancer Society recommended on those
16 lists that if you do smoke cigarettes you should
17 know the relative amounts of nicotine and tar in
18 your cigarettes, and the less tar and nicotine
19 you inhale the better?
7 MR. LOMBARDI: (Q) Did I get an answer
8 to that last question, doctor?
9 I'm sorry.
10 A. Would you repeat --
11 Q. I'll repeat the question.
12 You have no reason to deny that the
13 American Cancer Society recommended that the less
14 tar and nicotine you inhale the better, is that
15 correct?
16 A. I certainly have no reason to deny
17 that. The -- the issue is --
18 THE COURT: Okay. I think that's --
19 MR. LOMBARDI: (Q) Now, doctor, who was
20 Cuyler Hammond?
21 A. Cuyler Hammond was a Vice President of
22 Epidemiology and Surveillance Research from when
23 the department was started in the '40s until
24 roughly in the '70s.
186
1 Q. And let's say to step back because
2 you're -- I think you assumed something in your
3 answer.
4 He was with the American Cancer Society, is
5 that right?
6 A. Correct.
7 Q. Essentially -- and I'm not sure I
8 tracked exactly what your position was called,
9 was he one of your predecessors in your position?
10 A. Yes.
11 Q. And he published epidemiological
12 studies related to tobacco, didn't he?
13 A. Yes.
14 Q. And you're aware that he published some
15 studies in the 1970s, is that right?
16 A. Many studies about the hazards of
17 smoking.
18 Q. Okay. And you're aware specifically
19 that he published in the 1970 on epidemiology, is
20 that right?
21 A. Definitely.
22 Q. Okay.
23 MR. LOMBARDI: Your Honor, I have
24 handed the witness what's been marked as Exhibit
187
1 5203, and for the record I'll state that it is an
2 article from the Journal Environmental Research
3 titled "Tar and Nicotine Content of Cigarette
4 Smoke in Relation to Death Rates", authored by
5 Cuyler Hammond and others.
6 Do you see that, doctor?
7 A. Yes, I do.
8 Q. And that's an article you're familiar
9 with, is that correct?
10 A. Yes.
11 Q. And that's an article published by Dr.
12 Hammond back in 1976 when he was the Director of
13 Epidemiology and -- or I guess you said vice
14 president, I'm sorry. When he was with the
15 American Cancer Society. I'll make it easier, is
16 that right?
17 A. Yes.
18 Q. And this is an article that deals with
19 the epidemiology of low-tar cigarettes, is that
20 right?
21 A. Yes, it was one of the studies that we
22 included in Chapter 4 in the review.
23 Q. That's right.
24 And when Dr. Hammond worked on this study,
188
1 he was using the best information he had
2 available to him, is that right?
3 A. That's correct.
4 Q. And you have no reason to doubt the
5 integrity of the effort that went into this
6 article I take it, is that right?
7 A. Correct.
8 Q. Okay. You have no reason to doubt
9 that Dr. Hammond and others were trying to give
10 the public health community the best information
11 they had on epidemiology at the time, is that
12 right?
13 A. That is correct. That --
13 MR. LOMBARDI: (Q) You came to the
14 American Cancer Society in 1989, is that right?
15 A. Correct.
16 Q. And you're familiar with the
17 publication called "Cancer Facts and Figures", is
18 that correct?
19 A. Correct.
20 Q. And that is a document that the
21 American Cancer Society publishes, is that
22 correct?
23 A. Correct.
24 Q. And it published that document at the
191
1 time at least one was published during 1989 when
2 you were at the American Cancer Society, is that
3 right?
4 A. Correct.
5 MR. SWEDLOW: Just for clarification,
6 are we using these MIPM numbers?
7 MR. LOMBARDI: Yes, we are.
8 (Q) And, Your Honor, I placed in front of
9 the witness what's been marked as 5219 which for
10 the record I'll state is the American Cancer
11 Society's "Cancer Facts and Figures, 1989".
12 Do you see that document, doctor?
13 A. Yes, I do.
14 Q. And is that one of the Cancer Facts and
15 Figures publications that you referred to
16 earlier?
17 A. Yes.
18 In fact this was the last one to my
19 knowledge that mentioned the passage you're about
20 to point out.
21 Q. Okay, and there was -- you've made
22 reference to the last one. This was a
23 publication that came out periodically, is that
24 right?
192
1 A. Annually.
2 Q. Okay. And this was -- does it still
3 come out today, the publication?
4 A. Yes.
5 Q. Okay.
6 A. And this is not in it.
7 Q. Okay. Well, you're anticipating where
8 I'm going, but let's go to page 21, 5219.21, and
9 I have highlighted something under the heading
10 "lower tar and nicotine". I think you knew where
11 I was going, doctor. So are you there?
12 A. Yes, I'm here.
13 Q. Okay. And the first thing I have
14 highlighted there at the bottom of the first
15 paragraph under "lower tar nicotine", is it says
16 "moreover low-tar nicotine smokers find it easier
17 to quit altogether than high-tar nicotine
18 smokers".
19 Do you see that?
20 A. I do see it, but I disagree with the
21 implication.
22 Q. Okay. Well, in any rate that's what
23 the organization that you were with in 1989 said
24 in this publication, is that right?
193
1 A. Correct. That's what the Cuyler
2 Hammond who put out this group said.
3 Q. Okay. And in the next paragraph it
4 says, "in an ACS study conducted from 1960 to
5 1972, the average mortality of low-tar nicotine
6 smokers was sixteen percent lower than that of
7 high-tar nicotine smokers, and the comparable
8 figure for lung cancer mortality was twenty-six
9 percent".
10 Did I read that correctly?
11 A. You did.
12 Q. And that's what was in Facts and
13 Figures back in 1989, is that right?
14 A. That's correct.
15 Q. And that was at that time the best
16 information that was available for the American
17 Cancer Society, is that right?
18 A. That particular year was the year that
19 American Cancer Society moved from New York to
20 Atlanta, and it was an overlap year in which
21 Larry Garfinkel who had been successor in New
22 York co-authored Facts and Figures with the
23 Atlanta -- with Clark Heath.
24 Larry Garfinkel had been involved in these
194
1 studies, and that is why that persisted at that
2 point and was discontinued afterwards. In other
3 words, we disagreed with this point of view.
4 Q. Okay. It still went out under your
5 organization's heading, is that right?
6 A. That's correct.
7 Q. Okay. Now, doctor, I think you said
8 you started to get involved in the tobacco
9 epidemiology area in the early nineties, did you
10 say?
11 A. I began to do research specifically on
12 tobacco in the early nineties.
13 Q. Okay. And you did not participate in
14 NCI Monograph Number 7, is that right?
15 A. Correct.
16 Q. Okay. Is that something that you
17 referred to in coming to your understanding of
18 the epidemiology of tobacco use?
19 A. It's something that I'm familiar with
20 and that I take into account.
21 Q. Okay.
22 MR. LOMBARDI: Give me a copy of
23 Monograph 7.
24 I believe the Court has a copy already,
195
1 Your Honor.
2 (Q) Doctor, I don't know whether you
3 prefer to look on the screen or the big bulky
4 copy, but this is Monograph 7, and can you tell
5 that by looking at the cover?
6 A. Yes.
7 Q. Okay, and then Chapter 6 is what I'm
8 interested in asking you about, and that's at
9 page 77 of the document.
16 A. There is no page 77 in mine.
17 MR. LOMBARDI: Is that right? Well,
18 that's a mistake.
19 Thank you.
2 MR. LOMBARDI: There's page 77. I'll
3 put the rest of it right here for you.
4 For the record, Judge, it was in there.
5 THE COURT: I'm -- Go ahead.
6 MR. LOMBARDI: (Q) Dr. Thun, you found
7 page 77 now?
8 A. Correct.
9 Q. That is the article by Jonathan Samet,
10 correct?
11 A. Correct.
12 Q. I guess I should call it a chapter
13 properly, is that right, doctor?
14 A. It is a chapter.
15 Q. And you referred to Jonathan Samet
16 earlier in your testimony, is that right?
17 A. I did.
24 (Q) Dr. Thun, on Monograph 13 do you
198
1 still have that up there?
2 A. Yes.
3 Q. Monograph 13, Chapter 4, is the one we
4 have been referring to today, is that right?
5 A. Yes.
6 Q. Now, what Monograph 13 purports to do
7 is to go through the epidemiological research and
8 studies that have been done over time, is that
9 right?
10 A. Correct.
11 Q. And it purports to then analyze those
12 studies, is that right?
13 A. And summarize them.
14 Q. And then come to conclusions based on
15 that, is that right?
16 A. Yes.
17 Q. And Monograph 13 specifically considers
18 the, what is it, probably three decades of
19 epidemiological work that had been done with
20 respect to tobacco use, is that right?
21 A. Correct.
22 Q. And --
23 A. Well, more than three decades, but
24 since this is -- this is lower-yield cigarettes
199
1 --
2 Q. And I accept that clarification. And
3 you referred to a table called Table 4.1 which
4 went through the studies that you selected for
5 this monograph to specifically analyze, is that
6 right?
7 A. Correct.
8 Q. And Table 4.1 I believe was at page 82,
9 and that's 7109.97.
10 And you can see, and I'm not going to ask
11 you to count all the studies, doctor, but there
12 are a large number of studies listed here, is
13 that right?
14 A. Correct.
15 Q. And these studies you can see by
16 looking at the dates, for instance, the very
17 first one was from 1968.
18 You see down there at the bottom?
19 A. I think that time period of the study
20 is 1960 to 1966 actually, but that's the date it
21 was published.
22 Q. And that's what I was referring to the
23 date it was published?
24 A. Correct.
200
1 Q. And then just -- just to show you a few
2 more examples, down at the bottom there's one
3 that says 1976; is that right?
4 A. Yes.
5 Q. Okay. And then why don't you go to the
6 next page, Jamil.
7 There's one from 1981 at the top. See
8 that, doctor?
9 A. Yes.
10 Q. Let's go to the next page. There's one
11 from 1995 there in the middle it says Tang.
12 Do you see that one?
13 A. Yes.
14 Q. Okay. 1979 right below that, do you
15 see that?
16 A. Yes.
17 Q. Okay, go to the next page, please,
18 Jamil, and so forth. And if you could just
19 scroll the remaining pages, Jamil.
20 Okay. So that's -- it's a large group of
21 epidemiological studies, is that right?
22 A. That's correct.
23 Q. And you characterized what those
24 studies showed in the monograph, don't you?
201
1 A. Yes.
2 Q. Let's go back to page 81, doctor.
3 71.09.96.
4 And that first right here the heading is
5 "Published Epidemiological Studies of Health End
6 Points".
7 Do you see that?
8 A. Yes.
9 Q. And this is where you start to discuss
10 those studies, is that right?
11 A. Correct.
12 Q. Okay. And then let's -- we're talking
13 specifically about lung cancer here, is that
14 correct?
15 A. Table 4-1 is lung cancer.
16 Q. So tables 4.1 to 4.3 present
17 "epidemiological evaluations of smokers who used
18 cigarettes with filters or different levels of
19 machine-measured tar yield. An effort was made
20 to include all of the published studies that
21 evaluated individual smokers and presented
22 numerical risks of disease associated with
23 lower-yield cigarettes".
24 Do you see that?
202
1 A. I see that.
2 Q. And that does accurately characterize
3 what your effort was in this part of the
4 monograph, is that right?
5 A. Definitely.
6 Q. Okay. Now, the next highlighted
7 portion --
22 MR. LOMBARDI: (Q) Talks about Table
23 4.1 specifically, Dr. Thun, right?
24 A. Correct.
203
1 Q. Okay. And it then in the second line
2 goes on to describe the studies and it says,
3 "while a few studies have not found a
4 relationship, and several of the relationships
5 identified were not statistically significant,
6 the clear impression from these studies taken as
7 a whole is that there is a lower risk of lung
8 cancer among populations of smokers who use
9 lower-yield products. This relationship is
10 evident in case-control studies as well as in
11 prospective mortality studies".
12 Did I read that, right?
13 A. You read it correctly.
14 Q. And you agree with that, is that right?
15 A. Well, I also agree that it's discussed
16 further below.
17 Q. Absolutely, doctor. I just asked you
18 do you agree?
19 A. I agree that's what it says.
20 Q. Okay. Well, not just that that's what
21 it says. Do you agree that the clear impression
22 from the studies taken as a whole is that there's
23 a lower risk of lung cancer among populations of
24 smokers who use lower-yield products?
204
1 A. Literally that is true. The question
2 is why.
3 Q. Okay. Now, this was the -- this --
4 this Table 4.1 was the body of epidemiological
5 evidence that existed at the time you came in to
6 analyze Monograph 13, is that right?
7 A. Correct.
8 Q. Okay, then you took that evidence
9 together, the epidemiological evidence together,
10 and you looked at it critically, is that right?
11 A. Right.
12 Q. And you came to some conclusions that
13 people hadn't come to before about that evidence,
14 is that right?
15 A. The change in thinking about reduced-
16 yield cigarettes actually occurred over a longer
17 time period than you were suggesting. All of the
18 information about compensatory smoking sort of
19 reached the published scientific literature
20 during the nineties, and another thing that had
21 happened was the demonstration that lung cancer
22 risk in smokers was actually higher in the second
23 American Cancer Society study than the first
24 American Cancer Society study despite the fact
205
1 that people were predominantly smoking reduced-
2 yield cigarettes in the second and predominantly
3 unfiltered cigarettes in the first.
4 So this C change that you are describing
5 did not occur instantaneously with the
6 publication of Monograph 4. It really had been
7 developing for a decade.
8 Q. Actually, I didn't talk about any C
9 change, did I, doctor?
10 A. I interpreted you to be saying that.
11 Q. Well, I'll ask you the questions and
12 just try and take my questions at face value if
13 you could.
14 What I am asking you, sir, is these
15 documents, these studies that are in Table 4.1
16 you did a new analysis of for the purposes of
17 Monograph Number 13; is that right?
18 A. No. This studies in 4.1 we simply
19 arrayed in the table and then discussed their
20 strengths and limitations.
21 Q. Okay, but the discussion of their
22 strengths and limitations is something that you
23 in Monograph 13 were doing for the first time, is
24 that right?
206
1 A. It's the first time it was being done
2 in this coherent and broad a way, correct.
3 Q. Okay. And so you took a look at all
4 the studies that you have arrayed there, and you
5 decided that, you know, wait a minute, despite
6 this clear impression from these studies taken as
7 a whole that there's a lower risk of lung cancer
8 among populations who use lower-yield products;
9 it's not what it appears. That's -- that's
10 essentially what you did, is that right?
11 A. Correct.
12 Q. Okay. So you -- you went in and you
13 did this analysis. When was -- by the way the
14 work you did on this analysis, was it about 2000?
15 In the year 2000?
16 A. Yes.
17 Q. So -- so you took all of these studies
18 and you did your analysis in the year 2000, and
19 one of the things just to state it generally,
20 doctor, and we can talk more about specifics, but
21 essentially what you said is that these studies
22 may have biases associated with them.
23 Is that right?
24 A. Correct.
207
1 Q. Okay. And -- and in a world of
2 epidemiology, a bias is something that might make
3 the results not be -- not accurate?
4 A. Give you the wrong answer.
5 Q. I'm sorry?
6 A. Give you the wrong answer.
7 Q. Okay. You're answering my -- you're
8 answering my -- I thought you were telling me I
9 was giving you the wrong answer. I understand,
10 all right.
11 THE COURT: That's the answer.
12 MR. LOMBARDI: (Q) If you have biases,
13 the study might give you the wrong answer?
14 That's what you're saying?
15 A. Yes.
16 Q. Thank you.
17 Okay, so and you when you did this study
18 when you are working in 2000, you were the ones
19 that first started -- that first published on the
20 biases that this whole group of studies in Table
21 4.1 had, is that right?
22 A. In this coherent and comprehensive of a
23 way.
24 Q. Right.
208
1 And then you came to conclusions at the
2 end, and I just want to make clear.
3 You're not here suggesting that there is no
4 evidence to support the idea that low-tar
5 cigarettes have reduced risk? That's not your
6 testimony, is it?
7 MR. SWEDLOW: I'm going to object.
8 We're mixing low tar and light here, and I just
9 want to make the record clear that he has not
10 defined "low tar".
11 THE COURT: Okay. Be sustained.
12 MR. LOMBARDI: Okay.
13 (Q) Doctor, do you use the term "low tar"
14 in this chapter?
15 A. I'm not sure whether the term "low tar"
16 appears at any point in the chapter.
17 Q. Okay. Is this chapter titled,
18 "Smoking Lower-Yield Cigarettes and Disease
19 Risks"?
20 A. Yes.
21 Q. You have an understanding of lower
22 yield?
23 A. I understand that it's a gradation that
24 goes all the way from thirty-seven milligrams
209
1 down to one milligram.
2 Q. Okay. But that's the title you gave
3 your chapter, is that right?
4 A. Correct.
5 Q. Okay. And so there's no -- no
6 confusion, you are talking about lower-yield
7 cigarettes in this chapter, is that right?
8 A. Well, they're actually is confusion
9 because you're asking me about the state of
10 evidence, but you're not defining where on the
11 gradient of machine-measured tar you're talking
12 about.
13 Q. Well, I'm talking about your chapter,
14 doctor?
15 A. But your question didn't define where
16 on the gradient the machine-measured tar your
17 question involves.
18 Q. Okay. Well, let's just go to the
19 summary, doctor.
20 Well, 7109.16.
21 MR. SWEDLOW: Have a regular page
22 number for that?
23 MR. LOMBARDI: (Q) It is 145.
24 And this is the summary, is that right,
210
1 doctor?
2 A. Correct,the summary of this one
3 section.
4 Q. Okay. "The three lines of evidence on
5 lung cancer risk in relation to changes in
6 cigarette design provide somewhat inconsistent
7 findings, perhaps reflecting methodological
8 limitations and the limited number of studies
9 available".
10 Is that right?
11 A. That's what it says.
12 Q. Okay. So there were -- you were
13 talking about three lines of evidence in the
14 course of your chapter, is that right?
15 A. Correct.
16 Q. You go on to say "that detailed
17 examination of lung cancer rates by age in the
18 United States and the United Kingdom provide
19 seemingly conflicting patterns from the two
20 countries".
21 You talked a little bit about some studies
22 from the UK in your direct I believe, is that
23 right?
24 A. Correct.
211
1 Q. Okay. "Lesser risks for more recent
2 cigarettes are one potential explanation for the
3 rapid decline of lung cancer mortality at younger
4 ages in the United Kingdom over recent years";
5 and that's true, right?
6 A. That is.
7 Q. Okay. And then you go on to say, that
8 in the United States you have an inconsistent
9 result. I'll just read it.
10 However, "the temporal pattern of lung
11 cancer mortality at younger ages in the United
12 States is not consistent with this explanation.
13 The temporally cross-sectional findings from
14 several case-control and cohort studies provide
15 some evidence of reduced risk for smokers of
16 lower-yield products at time points across the
17 1960s through the 1980s".
18 Now, that is referring to all of those
19 studies we saw in Table 4.1, is that right?
20 A. Correct.
21 Q. "These studies, however, provide only
22 relative comparisons of risk and data analysis
23 methods raise concern about biased findings in
24 some". And when you say "in some" you're saying
212
1 in some of those studies they're concerned about
2 -- there are concerns about bias findings, is
3 that right?
4 A. Well, actually I have a concern that
5 the selection of -- of people with lower nicotine
6 requirements to use these products is a problem
7 that affects all of these studies. And so
8 that's a -- that limits the informing of all of
9 these studies, although the word there is "some".
10 Q. Okay, but on that point, that nicotine
11 point, have you published on that point?
12 A. Published on what point?
13 Q. The nicotine point you just read, that
14 you just said was your concern?
15 A. Yes, I have.
16 Q. Okay. What is that article called?
17 A. It's the one that was introduced
18 earlier by Mr. Swedlow, in tobacco control the
19 critical review of the epidemiology of the
20 reduced-yield cigarettes.
21 Q. That's the article that parallels
22 defines the monograph, is that right?
23 A. Correct.
24 Q. Okay. The -- let's see where was that
213
1 -- let's go down to the next one, please.
2 "The different findings across these three
3 lines of epidemiological evidence cannot be
4 reconciled with available information".
5 Okay, so what you're saying there, your
6 group is saying, is that there are these three
7 lines of epidemiological evidence and there is
8 some conflict among the evidence that we have?
9 A. Correct.
10 Q. And you can't reconcile them altogether
11 based on the evidence that you have, is that
12 right?
13 A. That's correct.
14 Q. Okay.
15 A. Now, you must remember that as we
16 pointed out, this chapter is talking about the
17 entire range of tar, not just the range of tar in
18 this case.
19 Q. Okay, well this was your chapter?
20 A. And that's what it's talking about.
21 Q. Okay, and this has been -- we have been
22 told that Chapter 13 -- the Monograph 13 is the
23 center point of this case.
24 MR. SWEDLOW: Objection.
214
1 MR. LOMBARDI: Have you heard that?
2 MR. SWEDLOW: That has not been said
3 and this witness has never heard that.
4 THE COURT: Be sustained. Sustain your
5 objection.
6 MR. LOMBARDI: (Q) And so then you
7 come to really the ultimate conclusion here. You
8 said, "overall, however, they do not provide
9 evidence that public health has benefited from
10 changes in cigarette design and manufacture over
11 the last fifty years".
12 Do you see that?
13 A. I definitely see that.
14 Q. Okay. And what that does not say is
15 that it doesn't say that there is proof that the
16 public health has not benefited?
17 A. It does not say that, that's correct.
18 Q. It says there's an absence of proof
19 that there is a benefit?
20 A. That is correct.
21 Q. Okay, and there's a difference in that
22 wording, isn't that right?
23 A. There definitely is a difference.
24 Q. Okay. Because you know having worked
215
1 on this monograph, you talked about the process
2 of coming to the consensus for this monograph.
3 Do you remember that?
4 You have to answer audibly; I'm sorry.
5 A. I do remember.
6 Q. Okay, and you talked about how you
7 worked with some of the reviewers on the
8 monograph?
9 A. Correct.
10 Q. And --
11 A. Which -- which is the -- a part of the
12 process dealing with any complex topic.
13 Q. I'm not suggesting there is anything
14 wrong with it, doctor. I'm just trying to get us
15 back at that frame of mind, that time frame
16 before the monograph came out. Well, I guess
17 step back a second.
18 Dr. Burns you mentioned, Dr. David Burns,
19 he was one of the authors of the monograph?
20 A. He's the first author.
21 Q. And when you say he's the first author,
22 is it fair to say that he was -- if you had to
23 choose among the authors he was the most
24 responsible for this chapter of the monograph;
216
1 would that be fair to say?
2 A. Well, he wrote the first draft, and
3 that makes him the first author. But because
4 there was a lot of input from people, I don't
5 want you to imply that -- that this is his work
6 masquerading as just --
7 Q. No, no, no. And that's not my
8 intention at all, doctor. But I just mean if you
9 had to break it down to say who took the laboring
10 more here or who was working with the drafts most
11 and who did most of the analyses on initial
12 basis, would you agree it was Dr. Burns?
13 A. I would agree on an initial basis,
14 that's true.
15 Q. Okay. Now, other people got involved
16 in the process though including yourself, is that
17 right?
18 A. Well, not just in the process, other
19 people were involved all the way along.
20 Q. Okay. And these other people were
21 reviewers such as Richard Peto, P-e-t-o, is that
22 right?
23 A. (No response)
24 THE COURT: Somewhere in here I want to
217
1 take a break. So let me know --
2 MR. LOMBARDI: It would be fine.
3 THE COURT: Let's not worry -- All
4 right, we'll take a half hour break.
5 (Whereupon, the noon
6 recess was taken
7 at this time.)
1 THE COURT: You may be seated. You may
2 proceed.
3 (Further Cross-Examination by Mr. Lombardi
4 of Dr. Thun.)
5 MR. LOMBARDI: Thank you, your Honor. I am
6 going to hand a document to Dr. Thun.
7 A. Thank you.
8 Q. Make sure, there you go. Your Honor, for the
9 record I have handed the witness Exhibit 4456.
10 Do you have that, Dr. Thun?
11 A. Yes.
12 Q. Okay. And for identification purposes on the
13 cover page, it says Low-Yield Cigarettes, What is the
14 Evidence for Benefit/Harm? Do you see that?
15 A. I do.
16 Q. And you are listed as one of three authors, is
17 that right?
18 A. Correct.
19 Q. Did you prepare this document?
20 A. I did. Do you want me to tell you what it is?
21 Q. No, I just asked you --
22 THE COURT: Just answer the question.
23 A. I did.
24 MR. LOMBARDI: Q. It is a document that
3
1 assembles some information that you had relevant to the
2 question of what is the evidence for benefit or harm of
3 low-yield cigarettes, correct?
4 A. Well, actually, it was the first attempt to do
5 so. This was a working document for an internal
6 presentation that I believe the tobacco companies got
7 Freedom of Information from the National Cancer
8 Institute so this was not a final document; this was a
9 preliminary working document.
10 Q. But it is a document where you assembled
11 information about the evidence and benefit or harm of
12 low-yield cigarettes, is that right?
13 A. Correct.
14 Q. Could you turn to -- the pages are not
15 numbered. The fourth page in, Doctor. To help you find
16 it, Doctor, What are the Available Data Suggesting
17 Benefit? Do you see that?
18 A. I do.
19 Q. And that I just -- in a general sense, on this
20 page you do other things and other parts of this
21 document, but on this page you are setting forth some of
22 the data that is available that suggests there might be
23 a benefit to low-yield cigarettes, is that right?
24 A. With the emphasis on suggest.
4
1 Q. And I understand that. That's what it says
2 right on the title, is that right?
3 A. Yes.
4 Q. And you chose that language, is that right?
5 A. Must repeat, this was an internal preliminary
6 working document, not a public.
7 Q. But you are the one that put that language
8 there, is that right?
9 A. Yes, I am.
10 Q. And you say ecological evidence. Could you
11 tell the Court what you mean by ecological evidence when
12 you are an epidemiologist?
13 A. Sure. I spoke earlier about looking at
14 national death rates from lung cancer. They are called
15 ecological because they pertain to a country or state,
16 and you don't have information on individuals so you
17 don't have information on how much -- whether the
18 individual smoked or how much. You just have rates in
19 the area.
20 Q. Okay. And the ecological evidence that design
21 changes in cigarettes may have contributed to a -- you
22 say that the ecological evidence is such that the design
23 changes in cigarettes, and by that you mean the lowering
24 of tar yields in cigarettes, is that right?
5
1 A. Correct.
2 Q. May have contributed to a decline in lung
3 cancer death rates at younger ages, correct?
4 A. Yes.
5 Q. And that is true, that is accurate, there has
6 been a decline in lung cancer death rates at younger
7 ages?
8 A. There has.
9 Q. And you also say that the ecological evidence
10 that design changes in cigarettes may have contributed
11 to the attenuation of the increase in lung cancer death
12 rates at older ages, is that right?
13 A. It is hypothetical whether there would have
14 been more of an increase, but these are two possible
15 pieces where -- for which there might be evidence of
16 benefit.
17 Q. When you say attenuation of the increase, you
18 mean the increase in lung cancer death rates has tailed
19 off a little bit, is that right, or is less?
20 A. No. I don't mean that. I mean, that in the
21 comparison of the first, the second American Cancer
22 Society study there is this enormous increase in lung
23 cancer risk in smokers, even though they have switched
24 to filter-tip cigarettes and with other things to reduce
6
1 machine-measured tar. And the question is, would the
2 rates have gone even higher were it not for the
3 introduction of your new products.
4 Q. So that is what -- that's what you are
5 referring to when you say the attenuation of the
6 increase in lung cancer death rates at older ages,
7 that's what you are referring to?
8 A. Correct.
9 Q. And then you have some charts in here as well.
10 I think the very next page, Dr. Thun, 4456.5?
11 A. Correct.
12 Q. We have the right page there, that is the next
13 page?
14 A. Yes.
15 Q. And that is headed Lung Cancer Death Rates at
16 Ages 30 to 34 and Cigarette Smoking Prevalence, Ages 25
17 to 34, UK, meaning United Kingdom, is that right?
18 A. United Kingdom.
19 Q. United Kingdom Men 1950 to 1997, and that
20 basically shows a comparison between the lung cancer
21 death rate and cigarette smoking prevalence, is that
22 right?
23 A. Correct.
24 Q. And by cigarette smoking prevalence, you mean
7
1 the number of people who smoke; is that right?
2 A. Percentage of people who smoke.
3 Q. And so, basically, what this chart is showing,
4 incidentally, this is one of the things that Richard
5 Peto, who is one of the reviewers of Chapter 4, was
6 interested in, this particular point, is that right?
7 MR. SWEDLOW: I am going to object. This
8 would call for hearsay knowledge; he lays a foundation
9 for his knowledge of another man's interests.
10 MR. LOMBARDI: Your Honor, I will withdraw the
11 question. I could get the foundation, but we will just
12 do this.
13 A. The same graph is presented in the critical
14 analysis of the epidemiological paper that I did with
15 Dr. Burns.
16 Q. Fine. And what this shows is that the
17 cigarette smoking prevalence, which is the line that
18 ends up at the top at the far right of the graph, is
19 that right?
20 A. The line at the top at the right.
21 Q. At the right?
22 A. Forty-eight percent chance.
23 Q. And then but there is a bigger drop in lung
24 cancer death rates, is that right?
8
1 A. In this age group in the United Kingdom and I
2 am going to contrast this with the United States.
3 Q. I understand that but what you are at least
4 considering the possibility of is that this is an
5 indication that the design of low-tar cigarettes were
6 responsible for the lung cancer rate dropping faster
7 than the prevalence of smoking rate, is that right?
8 A. That's one possible explanation.
9 Q. Okay. And the next page is a similar chart,
10 is that right, Dr. Thun?
11 A. The next page is age range 35 to 39, as
12 opposed to 30 to 34, so it's a similar point.
13 Q. But it graphically shows the same point. This
14 is another possible explanation for this difference in
15 the two lines on the graph is that the design of the
16 low-yield cigarette, is that right?
17 A. Correct.
18 Q. And there is some charts on UK women, which we
19 will just skip, Doctor, but you mention the US men so I
20 think the first chart on that --
21 A. Well, you might not want to skip the UK women
22 since they show the same percentage decrease in
23 prevalence as they show a decrease in lung cancer.
24 Q. I thought you wanted to talk about US men. I
9
1 was going to go to US men. And when you find that
2 chart, it is the first one after a page that says the
3 decline in lung cancer mortality is greater in -- do you
4 see that?
5 A. Yes.
6 Q. And then the page after that 4456.10 is lung
7 cancer death rates. And you list the ages again, but
8 this time it's for US men, is that right?
9 A. Yes.
10 Q. And the chart is a little bit different there,
11 is that right?
12 A. It is very different.
13 Q. Okay. But there is also -- there is also a
14 fact about the US men, Doctor, isn't it true that lung
15 cancer death rates are falling for younger smokers?
16 A. Lung cancer death rates are certainly falling
17 for younger smokers, but consumption and prevalence are
18 also falling.
19 Q. And you go through a bunch of other countries.
20 I am not going to detain us with going through every
21 country that you have in here. There are quite a few,
22 Doctor, but you do talk about towards the end lung
23 cancer histology?
24 A. Did you not want to make the point that in the
10
1 US --
2 THE COURT: Wait a minute; he is asking the
3 questions.
4 MR. LOMBARDI: Q. Histology. You remember
5 talking about histology this morning?
6 A. I do.
7 Q. And histology was when you were talking about
8 adenocarcinoma, is that right?
9 A. Yes.
10 Q. If you turn back, it is about, I would say,
11 about six or seven pages from the end. You see that?
12 A. Could you --
13 Q. The title is Possible Reasons for Changing
14 Lung Cancer Histology.
15 A. Yes.
16 Q. 4456.28.
17 A. I have it.
18 MR. SWEDLOW: Could you give a regular number
19 that we could follow for that?
20 MR. LOMBARDI: HHA710 312.
21 MR. SWEDLOW: Okay.
22 MR. LOMBARDI: I need --
23 THE COURT: Six pages from the back.
24 MR. LOMBARDI: Q. Okay. So here you are
11
1 talking about the possible reasons for the increase in
2 adenocarcinoma, is that right?
3 A. Yes.
4 Q. And the first one you list is artifact, what
5 does that mean to an epidemiologist?
6 A. That would be changes in the diagnosis,
7 changes in classification, et cetera. I should point
8 out that --
9 Q. Your Honor, I think that was the answer to my
10 question. And the second one is what you talked about
11 this morning was the changes in cigarettes or smoking
12 practices, is that right?
13 A. Correct.
14 Q. And then you list factors other than smoking.
15 What would factors other than smoking be that might
16 contribute to the change in lung cancer histology?
17 A. Well, since -- this is hypothetical -- since
18 the increase in adenocarcinoma in the United States has
19 occurred only in smokers, it is hypothetical. What I
20 was going to say is that I have listed all possible
21 things here, not probable causes, so this is listed for
22 completeness, not because I have in hand good evidence
23 that factors other than smoking, in fact, I have
24 evidence that factors other than smoking are not
12
1 responsible.
2 Q. I understand but you were -- just so it is
3 clear -- you are the person who decided to put the chart
4 together this way, is that right, yes or no, sir?
5 A. For this internal discussion group in which
6 we're kicking ideas around, correct.
7 Q. Thank you. Now, if you can go to the next
8 page, Net Impact on Lung Cancer. And I just want to go
9 to that last point there, the overall risk of lung
10 cancer has decreased among younger smokers. You see
11 that?
12 A. Yes, I do.
13 Q. And that's a significant point to an
14 epidemiologist, is that right?
15 A. Correct. With respect to this, it is hard to
16 separate the design changes in cigarettes from
17 reductions in the percent of people who are smoking and
18 their consumption.
19 Q. And I understand it's difficult to separate,
20 but at least one possibility you allow for is the
21 possibility that the overall risk of lung cancer has
22 decreased among younger smokers because of design
23 changes?
24 A. Speaking of design changes, including the
13
1 shift from filters to -- from unfiltered to filtered,
2 which isn't relevant to this case.
3 Q. But you are also including design changes
4 other than the shift from filtered to unfiltered. Let
5 me state the question to you. You admit the
6 possibility, there is at least a possibility out there,
7 that the overall risk of lung cancer has decreased among
8 younger smokers due to the development of the low-yield
9 cigarettes, is that right?
10 MR. SWEDLOW: I am going to object here again.
11 When Mr. Lombardi wants to, going to low yield blend to
12 concepts but he still has yet to define low yield for
13 any of these questions.
14 THE COURT: All right, sustain the objection.
15 MR. LOMBARDI: Q. Low yield is used in
16 Monograph 13 in your chapter of Monograph 13?
17 A. Yes. And what I am saying is that the third
18 is -- one possible explanation is that design changes in
19 cigarettes may have contributed, but that says nothing
20 about whether it was the large reduction in
21 machine-measured tar that occurred with the addition of
22 filters or subsequent changes that are relevant to this
23 case.
24 Q. Thank you, Doctor. Now, incidentally, if you
14
1 had a smoker out there who was currently smoking a 35
2 milligram cigarette, based on your knowledge of the
3 epidemiology, would you advise them that they would be
4 better off -- they'd be better off quitting, that's,
5 obviously, what you would say first; correct?
6 A. That's actually what I would say first through
7 ten.
8 Q. But if you had to tell them that one cigarette
9 was preferable to another, would you tell them it would
10 be better to smoke an eleven milligram cigarette than a
11 35 milligram cigarette?
12 A. I would tell them maybe it would be one
13 through forty to quit. Because I think --
14 Q. Sir, you have made that point, but now I want
15 to know about it. You got to tell them one cigarette or
16 the other, and you have a thirty-five milligram, and
17 they are either going to continue smoking that or smoke
18 an eleven milligram. Would you tell them to continue to
19 smoke the thirty-five milligram cigarette?
3 THE COURT: Ask it some other way, fine.
4 MR. LOMBARDI: Q. Let me try again, your
5 Honor. I am talking to you as an epidemiologist, which
6 is what you testified to this morning, so that is clear,
7 Dr. Thun. Based on the epidemiology that you are aware
8 of, would it be better to smoke the thirty-five
9 milligram cigarette or the eleven milligram cigarette?
10 A. One of the conclusions in the Monograph is
11 that there is not sufficient evidence presently to
12 recommend that smokers switch to lower machine-measured
13 tar cigarette. And I would follow -- I would follow
14 that.
15 And, actually, I would talk with the person more
16 extensively. I wouldn't boil it into one sentence.
17 Q. And I understand that, but I just want to make
18 sure it is clear, in your mind there is no difference
19 between a thirty-five milligram cigarette and an eleven
20 milligram?
21 A. I didn't say that.
22 MR. SWEDLOW: Object.
23 THE COURT: I will sustain that.
24 MR. LOMBARDI: Q. Doctor, you had
16
1 correspondence with others of the authors on Chapter 4
2 during the course of your work drafting that chapter, is
3 that right?
4 A. Yes.
5 Q. And you had correspondence with Dr. Burns, is
6 that right?
7 A. Yes.
8 Q. And you expressed your opinions frequently
9 about some of the substantive issues that came up in the
10 monograph chapter in that correspondence, is that right?
11 A. Correct.
12 MR. SWEDLOW: Are you done with 4456?
13 MR. LOMBARDI: For the record, your Honor,
14 this is the document I have marked 4331, which I have
15 handed to the witness is an e-mail that has an American
16 Cancer Society emblem on it, and it appears to be from
17 Michael Thun to Dave Burns. Did I characterize that
18 correctly, Doctor?
19 A. Correct.
20 Q. And this is an e-mail you sent to Dr. Burns
21 during the course of your work on the Monograph, is that
22 right?
23 A. Yes.
24 Q. And this involved substantive issues
17
1 concerning the epidemiology and the analysis done in the
2 Monograph, is that right?
3 A. Yes.
4 Q. Okay. And when you wrote this, you were
5 intending to be fully honest with Dr. Burns; is that
6 right?
7 A. We were collaborating on trying to get a
8 chapter that accurately captured the state of the
9 science.
10 Q. Were you trying to be honest with Dr. Burns?
11 A. That's part of scientific research.
12 Q. Now, if we look at the top, you say, David, my
13 interpretation of the -- and you say light cigarette
14 issue is as follows. Is that what you said?
15 A. I did say that, but at that point I didn't --
16 I was really not referring to a specific tar thing. I
17 was talking about to the whole issue of gradations in
18 machine-measured tar. So if I were writing it today, I
19 would not use the word light cigarette.
20 Q. I am sure that is right. But at least then it
21 says that you are referring to my interpretation of the
22 light cigarette issue, and you say is as follows, right?
23 A. That's what it says.
24 Q. Okay. And then in the first heading you say,
18
1 numerous epidemiologic studies have found somewhat lower
2 lung cancer risk in smokers who have switched to filter
3 tip, lower yield cigarettes compared to smokers who
4 continue to smoke unfiltered high yield cigarettes.
5 That was true then, is that right?
6 A. That's true.
7 Q. That's true today, is that right?
8 A. It is true.
9 Q. Number 2. We will go ahead and show it. Your
10 analyses, and when you say your, you're talking about
11 Burns, is that right, Dr. Burns?
12 A. Correct.
13 Q. Suggest that these studies probably
14 overestimate any attenuation of lung cancer risk from
15 light cigarettes because they overcontrol for the
16 current number of cigarettes smoked per day one aspect
17 of compensatory smoking and undercontrol for other
18 differences between smokers who switch and those who do
19 not. That was accurate then, is that right?
20 A. You read it correctly.
21 Q. That was accurate at the time, is that right?
22 A. Yes.
23 Q. And it is accurate today?
24 A. Yes.
19
1 Q. Okay. And that refers to, in a more specific
2 way, to the general concept of some of the biases that
3 Dr. Burns and yourself were talking about with respect
4 to the epidemiological literature, is that right?
5 A. Correct.
6 Q. Number 3. Your analyses of CPS-1, now CPS-1
7 is that cancer prevention study that Dr. Hammond wrote
8 about back in the seventies, is that right?
9 A. Correct.
10 Q. Confirm that any attenuation in lung cancer
11 risk associated with switching to lower yield cigarettes
12 is sensitive to prior assumptions and to the
13 methodologic approach. That, again, is referring in a
14 more specific way to these biases that you and Dr. Burns
15 have been talking about, is that right?
16 A. Yes.
17 Q. Okay. And then they say, they suggest that
18 the magnitude of the effect is likely to have been
19 overestimated by previous studies, correct?
20 A. That's what it says.
21 Q. And then you say, they don't provide solid
22 evidence of no effect?
23 A. And I agree with that.
24 Q. You agreed with it then?
20
1 A. And I agree with it now.
2 Q. And you agree with it now. Thank you. Number
3 4. When you say our comparison of lung cancer death
4 rates among smokers in CPS-I and CPS I think that's
5 probably supposed to be CPS-II at the end of that first
6 line, isn't it, Doctor?
7 A. It should be CPS-II.
8 Q. When you say our comparison, you're talking
9 about specific work that you had done?
10 A. Correct.
11 Q. And you wrote an article on that, is that
12 right?
13 A. Correct.
14 Q. And you're talking about what that article
15 showed in this paragraph, is that right?
16 A. Yes.
17 Q. And you said indicate that lung cancer risk
18 increased from CPS-I to CPS-II despite major changes in
19 the type of cigarettes being smoked, even after
20 controlling for smoking behavior in adulthood. That's
21 what you saw when you compared CPS-I to CPS-II, is that
22 right?
23 A. Sure.
24 Q. And then you say that your analysis there
21
1 indicate that things got worse, but they do not pinpoint
2 why, is that right?
3 A. That is correct.
4 Q. And that was accurate when you wrote it then?
5 A. Uh-hum.
6 Q. And it's accurate today, is that right?
7 A. Yes.
8 Q. One likely explanation is that whatever the
9 effect of light cigarettes, it did not prevent a large
10 increase in lung cancer risk in CPS-II compared to CPS-I
11 probably resulting from greater early life smoking.
12 A. That is one likely explanation; another
13 possible explanation is that something about the new
14 cigarettes was actually worse.
15 Q. But just what you said here?
16 A. Definitely, you read it correctly.
17 Q. And it was true when you said it?
18 A. Definitely.
19 Q. And it's true today?
20 A. Yes.
21 Q. Number 5. You said to Dr. Burns, Changes in
22 cigarette design are one possible explanation for the
23 more rapid proportionate decrease in lung cancer death
24 rates compared to smoking prevalence among young men,
22
1 and you give the ages, and to a lesser extent, women in
2 the UK.
3 A. That is correct.
4 Q. And we talked about that briefly before, is
5 that right?
6 A. Correct.
7 Q. And you still agree with that today, is that
8 right?
9 A. I do, although this was in the mid-points of
10 the discussion so it, too, doesn't represent the sort of
11 final resolution of these issues. It represents a
12 series of points, which I stated then, and they were
13 true then and true today, but they don't represent the
14 whole truth. I mean, there is more to the story than
15 what is in this particular e-mail.
16 Q. But, Doctor, I am just going on what you were
17 communicating with your collaborator on during the
18 course of your work on Monograph 13, right?
19 A. That is correct. But you are picking
20 something up in the mid-point of the collaboration not
21 something at the end of the collaboration, so I don't
22 want you to say that these points were my ending
23 conclusions about the whole story because they are not.
24 Q. I don't think I said that. I just asked you,
23
1 was that true then when you said it?
2 A. And it was true then and is true now.
3 Q. And that's all I wanted to ask you, Doctor.
4 Number 6. You say to Dr. Burns, Changes in cigarette
5 design may also have contributed to the differences in
6 temporal trends in lung cancer mortality among older men
7 in different countries. You see that?
8 A. I do.
9 Q. That was true then, is that right?
10 A. Well, actually, should say younger men so it
11 is in error.
12 Q. Let's just so we got it clear on the record, I
13 will read it again and make sure I get it right this
14 time. Changes in cigarette design may also have
15 contributed to the differences in temporal trends in
16 lung cancer mortality among younger men in different
17 countries?
18 A. Yes.
19 Q. That was true then?
20 A. Yes.
21 Q. Okay. And that's true today?
22 A. Yes.
23 Q. Okay. All right. And then let's go to Number
24 6. With respect, I guess you have two 6s, counsel is
24
1 pointing out to me. Did you see that? You accidentally
2 misnumbered it.
3 A. Not every e-mail is perfect.
4 Q. And I am not criticizing you, but your counsel
5 was pointing that out. The next number 6.
6 A. There was a misspelling on the previous one.
7 Q. I saw it. I didn't even point it out. With
8 respect to smokers, the existing data do not
9 conclusively establish whether there is or is not any
10 attenuation in lung cancer risk associated with
11 switching to light cigarettes. You see that?
12 A. You have read the first sentence there
13 correctly. That paragraph goes on. You haven't
14 highlighted the rest of it.
15 Q. I will let you read it, Doctor, but my first
16 point is that was true then, correct?
17 A. Yes.
18 Q. And that is true today, correct?
19 A. Yes.
20 Q. Now, if you want to read the rest of the
21 paragraph, you may.
22 A. Well, it says in the last sentence, To the
23 extent that health claims about light cigarettes cause
24 smokers to defer cessation, any actual differences in
25
1 tar exposure would be overwhelmed by longer duration of
2 smoking a factor not considered in the published
3 epidemiological studies.
4 Q. Which means, when it says it's not considered
5 in the public epidemiological studies, there wasn't data
6 to evaluate that point in an epidemiological sense, is
7 that right?
8 A. Not only was there not data but the whole
9 issue wasn't considered.
10 Q. Okay. Fair enough. Doctor, you talked about
11 your article in Tobacco Control with plaintiff, and I
12 think you will find it is Plaintiff's Exhibit 51. Did
13 you find that, Doctor?
14 A. I did.
15 Q. I'm sorry. Go ahead and finish your drink.
16 A. I found it.
17 Q. Are we all set?
18 A. Yes.
19 Q. This is the article that you wrote with Dr.
20 Burns in 2001 or at least published in 2001 in the
21 journal called Tobacco Control, is that right?
22 A. Yes.
23 Q. And it basically parallels what you wrote in
24 Monograph 13, is that right?
26
1 A. It does.
2 Q. And you made reference to the fact that in
3 this document you talk about your nicotine theory and
4 how nicotine might confound the epidemiological
5 evidence, is that right?
6 A. Yes.
7 Q. And is it true, Doctor, that you mentioned
8 that theory, but you don't present any epidemiological
9 data on that theory in this article?
10 A. That is true.
11 Q. And you had another theory that --
12 A. You are characterizing that as a theory, and
13 the things you have been talking about before also are
14 theories.
15 Q. Doctor, you also talked about the theory that
16 the light cigarettes could delay cessation, you remember
17 that?
18 A. Yes.
19 Q. There is actually no good data on that either,
20 is that right?
21 A. I believe that other witnesses in this trial
22 are going to address that.
23 Q. Well, let's see what you said in the article,
24 okay, 4495.6, please. This is what you said. Well,
27
1 first you said, while many epidemiological studies have
2 found attenuated risks of lung cancer among people who
3 smoke these products, the extent to which these studies
4 may overestimate the magnitude of the lung cancer
5 association remains unclear, you see that?
6 A. I see that.
7 Q. Then you say, no studies have adequately
8 assessed whether health claims used to market reduced
9 yield products delay cessation among smokers who might
10 otherwise quit or increase initiation or relapse among
11 nonsmokers. That was accurate at the time you wrote it;
12 is that right?
13 A. The word is adequately. I don't -- I am not
14 the person who is going to be presenting that
15 information, but I was saying if you are trying to
16 assess the impact of products with lower machine
17 measured tar than higher ones, you would need to have
18 very solid information about the extent to which your
19 product is causing nonsmokers to start or causing
20 smokers to delay cessation, since that is an integral
21 part of the impact of the product.
22 Q. Are you finished?
23 A. Yes.
24 Q. Is that -- was that sentence accurate at the
28
1 time you wrote it?
2 A. Yes.
3 Q. Now, Doctor, you talked about an article by
4 somebody named Woodward?
5 A. Yes.
6 Q. Plaintiff's Exhibit 50. And this was the
7 article where you found some -- I might use the wrong
8 word, so correct me if I am wrong, I think you found
9 some gradation among tar level and risk, is that -- do I
10 have that right?
11 A. I think what the article showed was it had tar
12 categories that are more relevant to the tar categories
13 in this case than the articles in the older literature
14 which had much higher tar levels.
15 Q. And this article was published in 2001, is
16 that right?
17 A. I have to find it.
18 Q. I think you got it right there.
19 A. 2001 it was.
20 Q. This article actually it come out even after
21 the Monograph came out?
22 A. Yes.
23 Q. So you didn't have the ability to use this
24 article in coming to your conclusions in the Monograph,
29
1 is that right?
2 A. It is not mentioned in the Monograph.
3 Q. Obviously, nobody who was working before the
4 time of the Monograph had the ability to use this
5 article because the data wasn't unavailable; is that
6 right?
7 A. Correct.
8 Q. Okay. Now, there have been other articles
9 that have come out on low-yield cigarettes and lung
10 cancer since the time the Monograph came out, is that
11 right?
12 A. Yes.
13 MR. SWEDLOW: I'll stand up and make our
14 standing objection like Mr. Lombardi does. Until we
15 define low-yield cigarettes, I will have a standing
16 objection.
17 THE COURT: I will sustain that.
18 MR. LOMBARDI: Your Honor, the witness used it
19 in his chapter, and I am just using it the way he has
20 used it. I think I have said that to the witness a few
21 times, but I will discontinue, your Honor. You are
22 aware that other articles have been written about the
23 relationship between tar levels in cigarettes and lung
24 cancer risk since the time of the Monograph, is that
30
1 right?
2 A. I am.
3 Q. And you are aware that in some of those
4 articles there is still an attribution of reduced risk
5 to low-tar cigarettes?
6 A. Could you show me which articles?
7 Q. I would be happy to. Do you know there are
8 some out there that meet that description?
9 A. If you show me the article, I will be able to
10 confirm it.
11 Q. I am showing you Exhibit 3750 which, your
12 Honor, I will identify for the record, an article in the
13 Journal of Internal Medicine titled Tobacco Use and
14 Cancer Causation: Association by Tumour Type by H. Kuper
15 and others.
16 Do you have that, Doctor?
17 A. I have the article you gave me.
18 Q. Have you seen that article before?
19 A. I have seen it. It is a review. It is not an
20 original study.
21 Q. But, nevertheless, this one came out in 2002,
22 is that right?
23 A. That is the date of publication.
24 Q. That is after the Monograph, is that right?
31
1 A. Correct.
2 Q. Could you turn to the third page of the
3 article, which I think bears the number 208. And I
4 will try and focus in here, Doctor. I am in the second
5 column, Doctor.
6 A. Yes.
7 Q. And the first full paragraph in that column,
8 do you see that?
9 A. I do see.
10 Q. Says, The risk of lung cancer is lower amongst
11 smokers of low-tar and low-nicotine rather than high-tar
12 nicotine cigarettes, smokers of filtered rather than
13 unfiltered cigarettes and smokers of blond rather than
14 black tobacco.
15 Do you see that?
16 A. I do see also that the first sentence has four
17 references as opposed to the vast number of references
18 in the Monograph chapter.
19 Q. Your Honor, I mean, Doctor, I'm not meaning to
20 imply this is somehow better than the Monograph or
21 superior, all I am saying is, you would agree that at
22 least Kuper and his co-authors wrote this conclusion at
23 a time after the Monograph had come out, is that right?
24 A. Well, actually, I don't know when they wrote
32
1 it since it came out in 2002, the Monograph came out in
2 2001. I don't know how long it was in press or but I
3 will say that this is a broad review of tobacco that
4 does not really go adequately into this issue, presents
5 no new data and no analysis of the data you're talking
6 about so I would not hold this up as strong evidence
7 against the conclusions of the Monograph.
8 Q. And I don't think I suggested it was. My only
9 question is, you don't have any reason to believe that
10 Kuper and his associates were saying something false
11 here, is that right?
12 MR. SWEDLOW: Object. I think the witness
13 already answered that question.
14 THE COURT: Be sustained.
15 MR. LOMBARDI: Q. Doctor, are you familiar
16 with an article by Ahmedin Jemal?
17 A. Yes, I am.
18 Q. Is it Dr. Jemal?
19 A. Dr. Jemal.
20 Q. Is he one of your colleagues?
21 A. Yes.
22 Q. And we saw him on that slide presentation that
23 you put together, is that right?
24 A. You saw his name.
33
1 Q. That's fair enough, Doctor. His name was
2 there listed as one of, I guess you call it, co-authors
3 of that slide presentation?
4 A. He was one of the co-discussants of the
5 preliminary in that working group.
6 Q. And Dr. Jemal had this article published in
7 February of 2001, is that right?
8 A. That is correct.
9 Q. And Dr. Jemal was -- well, let me just state
10 for the record, your Honor, and for the Court, it is
11 Exhibit 4159, and it has a heading at the top Cancer
12 Surveillance Series and the title Recent Trends in Lung
13 Cancer Mortality in the United States, and it's by
14 Ahmedin Jemal and some others.
15 Do you see that, Doctor?
16 A. I do.
17 Q. And that's a document you have before you, is
18 that right?
19 A. Yes.
20 Q. And that's a document you are familiar with,
21 is that right?
22 A. Yes.
23 Q. And Dr. Jemal does discuss the affect of
24 tobacco on lung cancer mortality, is that right?
34
1 A. Correct.
2 Q. Okay. Let's go to 4159.5 which, Doctor, is
3 page 281 of the document, and let's go down to the
4 second one, there you go. And he says there, thus, the
5 generally convex shape of the calendar period effect
6 curves from 1970 through 1990 likely reflects the impact
7 of the steadily improving trends in both carcinogen
8 exposure from cigarettes evidenced by the sharp decline
9 in tar and nicotine yield and smoking cessation over the
10 study period on the late-stage event. That's what Dr.
11 Jemal and his colleagues talked about in part in their
12 article, is that right?
13 A. Yes.
14 Q. Okay. Let's go to the next one, please. This
15 is at the bottom of the next column, very last two words
16 or three words or so, cigarette smoking is the
17 predominant cause of lung cancer. However --
18 A. I am confused as to where you are.
19 Q. I'm sorry. If you go to right over here on
20 the page we were just on.
21 A. I see, yeah.
22 Q. I think you are on the first page.
23 A. I am on this page.
24 Q. So it starts, cigarette smoking is the
35
1 predominant cause of lung cancer as you go over to the
2 next page?
3 A. Yes, there is no question about that.
4 Q. However, thus, the changes noted in the lung
5 cancer trend likely have their explanation in changing
6 exposure to cigarette carcinogens?
7 A. Also no doubt that changing exposure to
8 cigarette carcinogens, the only thing that is in doubt
9 is whether it is due to design changes in cigarettes or
10 changes in smoking behavior.
11 Q. Let's go on and see what he says. As noted
12 earlier, lung cancer trends over the next decade will
13 provide empiric evidence to either support or contradict
14 the suggested explanations for both slope changes
15 highlighted in this article.
16 Do you see that?
17 A. I do see it.
18 Q. You agree with that, don't you?
19 A. That future information will, undoubtedly,
20 extend our present knowledge, I agree with that.
21 Q. That's -- we need more knowledge in order to
22 come to firm conclusions on these things, is that right,
23 Doctor?
24 A. We don't always need more knowledge in order
36
1 to act appropriately now.
2 Q. That wasn't my question.
3 A. No. New knowledge is good.
4 Q. New knowledge is good, and the state of our
5 knowledge right now is not complete, is that right?
6 MR. SWEDLOW: Object, I have no idea the state
7 of what knowledge related to what that we're talking
8 about.
9 MR. LOMBARDI: The state of our knowledge about
10 epidemiology and low-tar cigarettes is incomplete at
11 this point, Doctor, is that right?
12 MR. SWEDLOW: I will object to the vague use
13 of the term low tar.
14 THE COURT: I think that is what this lawsuit
15 is about. Be sustained.
16 MR. LOMBARDI: Q. All I am asking, Doctor, is
17 we will get more information, epidemiological data, as
18 time goes on, is that right?
19 A. We always get more information as time goes
20 on.
21 Q. And we'll have, specifically, more information
22 that is more specific to the types of cigarettes that
23 are at issue in this lawsuit as time goes on, is that
24 correct?
37
1 A. It is always the case that as time goes on,
2 you get more information, but I don't know what you are
3 getting at.
4 Q. Well, I guess we'll just end it here, Doctor.
5 Do you agree with Dr. Jemal and his colleagues in this
6 article that lung cancer trends over the next decade
7 will provide empiric evidence to either support or
8 contradict the suggested explanations for both slope
9 changes highlighted in this article. Do you agree with
10 him?
11 MR. SWEDLOW: I'm going to object. He has
12 asked and now answered that question three or four
13 times.
14 THE COURT: Be sustained.
15 MR. LOMBARDI: I didn't realize I had it
16 answered, Judge.
17 THE COURT: Yeah.
18 MR. LOMBARDI: If I have got the answer, then
19 that's all the questions I have.
20 THE COURT: Redirect.
21 REDIRECT EXAMINATION
22 BY: MR. SWEDLOW
23 Q. Dr. Thun, do you still have in front of you
24 the Exhibits that we were just discussing?
38
1 A. Which one?
2 Q. I would like to start with the Cancer Facts
3 and Figures 1989 MIPM 5219.
4 A. Yes.
5 Q. You were asked to look at page 21, and on page
6 21 the language read in an ACS study conducted from 1960
7 to 1972, based upon all that you know, is that likely
8 CPS-I?
9 A. It is CPS-I.
10 Q. The average mortality of low tar and nicotine
11 smokers was sixteen percent lower than that of high-tar
12 and nicotine smokers. Do you know what the tar
13 categorization was in CPS-I with respect to low
14 nicotine, excuse me, low tar and nicotine smokers?
15 A. Would have been above the tar and nicotine
16 levels that are at issue in this case.
17 Q. Would both products, meaning Marlboro Lights
18 and Cambridge Lights, as well as Marlboro regular and
19 Cambridge regular, fall into the category under CPS-I
20 that were low tar and nicotine?
21 A. Yes.
22 MR. HEPLER: Objection as to time.
23 MR. SWEDLOW: Forever, how about that? Would
24 this be true from the beginning of the product launch
39
1 through today?
2 A. Yes, what I think you are asking, yes, that is
3 true.
4 Q. Turning to the document that was marked MIPM
5 4456 it's your preliminary, looks like a power-point
6 presentation. There were a few slides where you
7 weren't allowed to finish your thought. I would like to
8 let you finish your thought.
9 MR. LOMBARDI: I would object to the
10 characterization. I think I let the Doctor talk about
11 what he wanted to talk about.
12 MR. SWEDLOW: Q. Well, let me ask the Doctor
13 this question; did you have additional thoughts on these
14 slides that you didn't present?
15 THE COURT: I'm not even going to bother ruling
16 on that at this time. Go ahead.
17 MR. SWEDLOW: Q. The first slide is the one
18 that said what are the available data suggesting
19 benefit, and the discussion was regarding ecological
20 evidence that design changes in cigarettes may have
21 contributed to, and then you list a couple of things,
22 decline in lung cancer rates and attenuation of the
23 increase.
24 Is there any ecological evidence, whatsoever, that
40
1 light cigarettes like Marlboro Lights and Cambridge
2 Lights have led to decline in lung cancer death rates or
3 attenuation of increases as compared to Marlboro regular
4 and Cambridge regular?
5 A. Most of the ecological trends would be
6 attributable to the addition of filters not to
7 subsequent changes in cigarettes.
8 Q. When you were even considering the ecological
9 evidence here, were you speaking primarily of the
10 difference between a filter and a nonfilter cigarette
11 when you referred to design changes?
12 MR. LOMBARDI: Objection, leading.
13 THE COURT: Overruled.
14 THE WITNESS: I was speaking about the nature
15 of the ecological evidence, which doesn't look at all at
16 what people were smoking, but because of the timing of
17 the introduction of filters, the introduction of filters
18 would have been -- had a larger impact than subsequent
19 changes.
20 Q. The lung cancer death rate and cigarette
21 smoking prevalence data that we looked at in that same
22 power-point presentation we discussed, or you discussed
23 with Mr. Lombardi, the UK rate for men, but I wanted you
24 to turn to page 292 of this document, and I think that
41
1 you were referring to the UK rate for women associating
2 the lung cancer death rate and cigarette smoking
3 prevalence, what is the relationship between those two
4 numbers?
5 A. Well, in the women age 35 to 39, the
6 percentage change is identical in the lung cancer death
7 rate and in the cigarette smoking prevalence.
8 Q. What page are you looking at?
9 A. It is HHA7100292.
10 Q. Turning to the US men, which is at page 0294.
11 What does the comparison of lung cancer death rates and
12 cigarette smoking prevalence tell you?
13 A. Again, the change in the lung cancer death
14 rate and the change in the cigarette smoking prevalence
15 are parallel. They are equal, and so one does not need
16 to invoke anything other than reductions in the
17 percentage of people who are smoking.
18 Q. I asked you several opinions on Direct
19 Examination, and with the Court's indulgence I am going
20 to try to ask you one question related to those. The
21 opinions that you rendered with respect to the
22 epidemiological evidence associated with reduced tar and
23 reduced disease, were all of those opinions rendered
24 with a reasonable degree of scientific certainty?
42
1 A. I believe so. I mean, I try to put in
2 language expressing where there was uncertainty and the
3 other things are with -- definitely with a reasonable
4 degree of scientific certainty.
5 MR. SWEDLOW: I have no other questions.
6 MR. LOMBARDI: Just one question, your Honor.
7 RECROSS-EXAMINATION
8 BY: MR. LOMBARDI
9 Q. Doctor, is it true that lung cancer death
10 rates in CPS-II were thirty-three percent lower among
11 younger male smokers ages 40 to 45 than they were in
12 CPS-I?
13 MR. SWEDLOW: I guess I'll object for the
14 record that this is beyond the scope of my Redirect.
15 THE COURT Sustained.
16 MR. LOMBARDI: No further questions, your
17 Honor.
18 THE COURT: Are you done?
19 MR. TILLERY: We're finished with the witness,
20 your Honor.
21 THE COURT: All right. He will be excused
22 subject to calling him back in rebuttal. So you are
23 excused at this point, Doctor. Thank you. Next
24 witness.