Dr. David Burns - Testimony Excerpts
18 DIRECT EXAMINATION
19 BY MR. ZELCS
20 Q. Good morning, Dr. Burns.
21 A. Good morning.
22 Q. Where do you presently work?
23 A. I work at the University of California, San
24 Diego.
9
1 Q. And do you work in the medical school?
2 A. Yes.
3 Q. Tell us a little bit about your education. Where
4 did you go to college?
5 A. I graduated from Boston College, and then I went
6 for two years to Dartmouth where I received a Bachelor
7 in Medical Science from Dartmouth, and then I received
8 my Doctorate in Medicine from Harvard Medical School.
9 Q. What year did you obtain your medical doctor's
10 degree from Harvard?
11 A. 1972.
12 Q. After completing your medical school and getting
13 your degree, where did you do your internship or your
14 residency work?
15 A. I trained in internal medicine at Boston City
16 Hospital, on Harvard Medical Service at Boston city.
17 Q. After completing your residency and internship
18 work, what did you do next?
19 A. I then joined the Public Health Service for two
20 years, and I was a medical officer with the National
21 Clearinghouse for Smoking and Health.
22 Q. When you were serving as a resident in Boston,
23 what kinds of patients did you treat?
24 A. We treated all variations of general medicine
10
1 patients, patients with heart disease, lung disease,
2 cancer, GI disease, orthopedic problems, with the
3 exception of patients who were pediatric patients, were
4 surgical patients or were obstetrics and gynecology.
5 Q. Are you Board Certified in any specialty?
6 A. Yes. I'm Board Certified in internal medicine,
7 in pulmonary medicine, and I have a Certificate of
8 Special Achievement in critical care medicine.
9 Q. Have you ever been recognized by the American
10 College of Chest Physicians in any way?
11 A. Yes. I'm a Fellow of the American College of
12 Chest Physicians, and recently I was given the Alton
13 Ochsner Award at the American College of Chest Physician
14 meetings. That is an award for distinguished research
15 in smoking and health.
16 Q. What memberships have you maintained in
17 professional associations or societies that are related
18 to your professional expertise?
19 A. I'm a Member of the American College of Chest
20 Physicians, the American Thoracic Society, California
21 Thoracic Society, the Society For Research on Nicotine
22 and Tobacco, San Diego Pulmonary Society, American
23 Public Health Association, among others.
24 Q. How long have you held your current position at
11
1 the University of California at San Diego?
2 A. I've been on the faculty at the University of
3 California, San Diego since 1979, and I have been a
4 Professor of Medicine there for about twelve years.
5 Q. Roughly since 1991?
6 A. That's correct.
7 Q. In what departments do you work at the University
8 of California?
9 A. My primary appointment is in the Department of
10 Family and Preventive Medicine, but I also hold an
11 appointment in the Department of Medicine as well.
12 Q. What specific area of medicine do you practice
13 in?
14 A. My specialty is in lung disease, and I practice
15 in consultative practice in the hospital on lung
16 disease.
17 Q. Tell us a little bit about the scope of
18 responsibilities that this job entails.
19 A. When I am on consultative service, I provide
20 specific diagnostic and therapeutic advice to physicians
21 in the hospital on patients with lung disease of a
22 variety of different types including critical care
23 patients. I also interpret the pulmonary function
24 studies in the hospital. As part of that
12
1 responsibility, I teach medical students, interns,
2 residents and fellows about the diagnosis and management
3 of lung disease as well as the interpretation of
4 pulmonary function studies.
5 Q. When you talk about teaching, tell us about the
6 different levels of students or trainees that you teach.
7 A. Well, there are multiple levels of teaching that
8 occur within the medical context, particularly within
9 the clinical context. In general, I teach third and
10 fourth year medical students when they spend their time
11 on clinical services in the hospital. I also teach
12 interns and residents when they rotate through the
13 service or when I provide consults on individual
14 patients. And then both the residents and the fellows
15 sit with us in the pulmonary function laboratory and
16 learn to interpret the pulmonary function studies in
17 terms of how the physiology relates to various disease
18 states that patients have.
19 Q. Let's talk a little bit about how you divide up
20 your time. What percentage of your time do you
21 presently spend on the various activities?
22 A. Well, about eighty-five percent or ninety percent
23 of my time at the moment is spent on research activities
24 that relate to a series of investigations we're
13
1 conducting. They include measurement of disease risks
2 produced by smoking, evaluation of tobacco control
3 programs at the state and national level, examination of
4 the impact of public policy changes on smoking
5 behaviors, examining the effect of the media on smoking
6 behavior. I spend about five percent of my time on
7 patient care and teaching, and about five percent of my
8 time of late I've spent on litigation.
9 Q. Now, the way you describe the breakup of your
10 time, has this always been the case?
11 A. No. For the first fifteen years of my time
12 within the University, I spent about half of my time on
13 clinical activities. That included attending and being
14 responsible for patient care provided in the critical
15 care unit, medical intensive care unit at our hospital,
16 and I also ran the respiratory therapy department at our
17 medical center. The respiratory therapy department is
18 responsible for all of the mechanical ventilation,
19 artificial ventilation that occurs within the hospital.
20 It is also responsible for the delivery of oxygen,
21 delivery of a variety of medications that are provided
22 by an inhalational unit as well as various therapeutical
23 modalities related to respiration.
24 Q. You've been telling us about what you have been
14
1 doing at the medical school. Do you have any additional
2 responsibilities at the University of California?
3 A. Yes. I also head the Tobacco Control Policies
4 Project.
5 Q. Take some time and tell us what that project
6 involves.
7 A. Well, the Tobacco Control Policies Project is a
8 group that we have set up. It includes now myself plus
9 five other professionals. We do a variety of activities
10 that relate to examination of a very large population
11 based data sets and risk data sets. They include
12 predicting lung cancer death rates from smoking
13 behavior, examining the risks of smoking for various
14 diseases, examining and collecting information on print
15 media advertising and relating that to various smoking
16 behaviors as well as other changes in cigarette use. We
17 have done a substantial amount of work looking at the
18 impact of various public policy changes, taxes,
19 restrictions on the way people can smoke, physician
20 advice, other kinds of activities, that and the impact
21 of that on getting people to stop smoking or trying to
22 prevent from people from starting. We've also done some
23 work to evaluate the global impact of state-wide tobacco
24 control programs, both in California and Massachusetts,
15
1 as well as looking at some of the issues in initiation
2 and cessation nationally.
3 Q. How long has that project been in existence?
4 A. About ten years.
5 Q. And how long have you been affiliated with that
6 project?
7 A. I started it, and I headed it from the beginning.
8 Q. You indicated that you first became associated
9 with the University of California in 1976; is that
10 correct?
11 A. That's correct.
12 Q. And you have been a professor for about twelve
13 years. Can you describe the other positions that you
14 have held at the University of California?
15 A. Well, in 1976, I came to UCSD to train in lung
16 disease. I was a Fellow in chest medicine for three
17 years at UCSD. Then I joined the faculty as an
18 Assistant Professor. I received an accelerated
19 promotion to Associate Professor after six years, and
20 after another six years was promoted to full professor.
21 Q. How did you happen to choose the University of
22 California, San Diego for your pulmonary fellowship?
23 A. I had been interested for some time in chest
24 medicine, and UCSD was arguably the best training
16
1 program in the country in lung disease at that time, and
2 I applied and was accepted.
3 Q. Have we now covered all of the positions that you
4 have held at the University of California, San Diego?
5 A. I believe so.
6 Q. Other than working on the Tobacco Control Project
7 that you have told us about, have you served in any
8 additional smoking and health projects or in smoking and
9 health capacities?
10 A. Yes. I've served in a wide variety of capacities
11 with a number of different organizations.
12 Q. Why don't you go through some of those for the
13 Court and explain what they are and what your
14 involvement is with those projects or has been.
15 A. Well, among the activities I've conducted, I was
16 on the Research Advisory Board for the John F. Kennedy
17 School of Government Tobacco Policies Project. And that
18 consisted of examining their research work and providing
19 advice about how to conduct that work as well as what
20 opportunities might exist to do new projects. I have
21 served with the Consumer Product Safety Commission.
22 Q. Can I interrupt for just a minute?
23 A. Sure.
24 Q. When you talk about the Kennedy School of
17
1 Government, is that the school that is affiliated with
2 Harvard University?
3 A. Yes, it is.
4 Q. Go ahead.
5 A. I worked with the Consumer Product Safety
6 Commission in an effort to define the risks and more
7 specifically the changes in risk that might accrue with
8 producing cigarettes that had less ignition potential,
9 that is, that wouldn't cause clothing and furniture to
10 catch on fire if the cigarettes were left to burn
11 unattended. I have served with the Environmental
12 Protection Agency on their Indoor Air Quality Board, and
13 specifically in relation to their assessment of
14 environmental tobacco smoke exposure. I've served with
15 the National Cancer Institute on their Policy Advisory
16 Committee for the CommInTrial. The CommInTrial was a
17 community intervention where they tried to develop a
18 broad-based community approach to smoking cessation and
19 used eleven community pairs. I have served on the
20 Evaluation Committee for the State of California,
21 Tobacco Control Program, and I have also served on the
22 Tobacco Research and Education Oversight Committee which
23 is the legislatively mandated oversight committee for
24 the State of California's Proposition 99 funds, which is
18
1 a statewide tobacco control program. I have chaired an
2 evaluation for the State of Massachusetts on the
3 assessment of newer tobacco products. I've worked with
4 the American Cancer Society in a variety of different
5 capacities on their tobacco and health committee. I've
6 served on the board of the state organization, I've
7 chaired their Research Committee, and I've been
8 president of the local organization. I've also served
9 on boards of the local lung association, and have worked
10 with the state and national organizations and helped
11 them plan their tobacco control programs.
12 Q. Let me see if I have any others that I want to
13 follow up with you. Have you served in any capacity
14 with the American College of Chest Physicians?
15 A. Yes. I've been on the Tobacco and Health
16 Committee for the American College of Chest Physicians.
17 Q. And what about the San Diego Tobacco Control
18 Coalition? What has your involvement been there if any?
19 A. Yes. I chaired the San Diego Control Coalition
20 -- that was immediately after the passage of Proposition
21 99 -- to provide coordination and oversight to the
22 activities of both the county and the grants that were
23 awarded to individual community organizations within San
24 Diego County, all of which were focused on trying to
19
1 reduce the burden, the disease burden that smoking
2 caused in San Diego County.
3 Q. What about the U.S. Department of Health and
4 Human Services, have you worked with them or consulted
5 with them?
6 A. I've been a consultant with the Department of
7 Health and Human Services for 25 years now, and that
8 included consulting with the National Cancer Institute
9 to help them design their tobacco control efforts. I've
10 also chaired a number of grant reviews for the National
11 Cancer Institute and participated in others.
12 Q. You know, when I first put you on the stand, I
13 said good morning to you, but I didn't ask you to give
14 us your full name. Why don't you do that now. It is
15 kind of an awkward place, but we had might as well get
16 it done.
17 A. My full name is David Michael Burns.
18 Q. I apologize. Thank you very much. Additionally,
19 have you done any work with the State Attorney Generals?
20 A. Yes. I was involved with twenty-five or so of
21 the Attorney Generals when they were suing the tobacco
22 companies for recovery of Medicaid expenditures among
23 other causes of action. I've also worked with the State
24 of California Attorney General in his efforts to enforce
20
1 the Master Settlement Agreement that settled the
2 Attorneys General litigation, and I have worked with the
3 National Association of Attorneys General in their
4 efforts to examine the question of how they would
5 respond to claims made about newer tobacco products.
6 Q. Let's talk a little bit now about honors or
7 awards that you have received recognizing your work in
8 the field of smoking and health. Earlier on, you
9 mentioned briefly the Oschner Award. Will you tell the
10 Court exactly what the Alton Oschner Award is and give
11 me a little background on that?
12 A. Alton Oschner was one of the founders of thoracic
13 surgery in the United States. He was a thoracic surgeon
14 who was in medical school in the 1920s, and he described
15 to me in medical school being called out of the dorm at
16 night to witness an autopsy because this was a case of
17 lung cancer and he might never again in his professional
18 life see another case of lung cancer. In his first year
19 of practice as a thoracic surgeon, he saw four cases,
20 and he concluded that there must be an epidemic. He was
21 one of the very early individuals to identify the
22 relationship between smoking and lung cancer. He went
23 on to found the Oschner Clinic in New Orleans and to be
24 an internationally recognized thoracic surgeon.
21
1 Throughout his life, he devoted a great deal of his
2 energy to educating the public about the relationship
3 between smoking and disease. When he died, the American
4 College of Chest Physicians in conjunction with the
5 Oschner Foundation developed an award that is given out
6 in his name for conducting distinguished research in
7 smoking and health.
8 Q. When were you honored with that award?
9 A. This last year in San Diego, at the ACCP meeting
10 in San Diego.
11 Q. Have you also received the Joseph Cullen Memorial
12 Award?
13 A. Yes.
14 Q. Would you tell us what that award is who
15 Dr. Cullen was?
16 A. Dr. Cullen was one of the Associate Directors at
17 the National Cancer Institute, and he quite rightly is
18 given credit for encouraging and facilitating the large
19 body of research that the National Cancer Institute has
20 funded in the area of tobacco and health. He tragically
21 died early in life from brain cancer, and the American
22 Society of Clinical Oncology has named an award in
23 distinguished service and preventive oncology in his
24 name. I received that award as well.
22
1 Q. The American Lung Association Life and Breath
2 Award, can you tell us when you received that and what
3 that is about?
4 A. Yes, I did. And that is an award that I received
5 for my work on environmental tobacco smoke.
6 Q. Any other awards that you received that you would
7 like to tell us about?
8 A. Yes. Perhaps the award that I am proudest of is
9 the Surgeon General's Medallion. I was awarded that
10 award, medallion by C. Everett Koop, who was the Surgeon
11 General at the time. And it was for my contributions
12 nationally to educating the public and the scientific
13 community about issues relating to smoking and health.
14 Q. You've told us now about various local, state,
15 federal government agencies that have asked you to
16 consult with them about various awards that you have
17 been given. Have you been asked to consult with any
18 foreign governments or any worldwide organizations?
19 A. Yes. I have testified for the Attorney General
20 of Canada in a lawsuit that as I understand it, the
21 tobacco companies sued to overturn the laws in Canada on
22 restrictive advertising. I've also been part of an
23 expert committee convened by the Canadian Minister to
24 examine the question of whether low tar and nicotine
23
1 cigarettes reduce disease risks and whether the terms
2 light, ultralight, mild, et cetera, were misleading
3 terms. I've also served both as an expert and now as a
4 member of the World Health Organization's Scientific
5 Advisory Committee on Tobacco.
6 Q. Tell us a little bit about what the World Health
7 Organization is and where it is located?
8 A. Well, the World Health Organization is located in
9 Geneva, Switzerland, and its responsibilities include
10 dealing with the public health and disease burdens that
11 occur throughout the world and to try to reduce the
12 amount of disease and illness that occurs throughout the
13 world.
14 Q. Have you published any articles which relate to
15 the topic of the health consequences of smoking?
16 A. Yes. I've published a substantial number of
17 articles on that topic.
18 Q. Can you describe a couple of your representative
19 publications?
20 A. Well, they include chapters in both of the
21 principal textbooks of medicine. There are two major
22 textbooks of medicine used in medical schools across the
23 United States. One is the Cecil Textbook of Medicine,
24 and the other one is the Harrison Textbook of Medicine.
24
1 I've authored chapters in both of those texts. I've
2 also published work on the effects of cessation in the
3 elderly, the relationship between media campaigns and
4 other tobacco control efforts, changes in smoking
5 behavior, and a variety of other topics.
6 Q. Now, let's go back in time and develop your
7 career a little bit more. Prior to when you came to the
8 University of California, San Diego, where were you
9 employed?
10 A. I was employed as a medical officer at the
11 National Clearinghouse for Smoking and Health, which was
12 part of the Bureau of Health Education at the Centers
13 for Disease Control in Atlanta, Georgia.
14 Q. And during what years were you with the National
15 Clearinghouse for Smoking and Health?
16 A. I was there from 1974 through 1976.
17 Q. While in Atlanta at the Clearinghouse, did you
18 also serve in any teaching capacity?
19 A. Yes. I was also an instructor at Emory Medical
20 School. I taught medical students physical diagnosis,
21 which is taking a history and doing a physical
22 examination of patients.
23 Q. If the Court is following what you have said, I
24 think this would be your first job after residency and
25
1 internship; is that right?
2 A. The National Clearinghouse, was, yes. The other
3 was a voluntary job.
4 Q. How did you end up at the National Clearinghouse
5 after doing your residency and internship?
6 A. Well, during my senior year at Harvard Medical
7 School, they called the class together. At that time,
8 all physicians were required to provide service for two
9 years. And they told us that they were a variety of
10 ways we could do that, and one of the ways that we could
11 very effectively use the training that we had had was to
12 go into public health service. It would allow us both
13 to do things that were meaningful and productive as well
14 as be a valuable educational experience. So I applied
15 to the Centers for Disease Control for a variety of
16 different positions, and I was selected for the National
17 Clearinghouse.
18 Q. Let me see if I can clarify this. I think you
19 said the National Clearinghouse was associated with the
20 CBC; is that right?
21 A. The National Clearinghouse was part of the Bureau
22 of Health Education, which was one of the bureaus within
23 the Centers for Disease Control at that time.
24 Q. The bottom line was it was a governmental agency?
26
1 A. Oh, yes. It was one of the agencies of the
2 Public Health Service, U.S. Public Health Service.
3 Q. You said you were a medical officer there. Tell
4 us what responsibilities you had in that position as
5 medical officer?
6 A. I had the grand title of Medical Staff Director
7 of the National Clearinghouse. My principal
8 responsibility was to prepare the 1975 Surgeon General's
9 Report, to write it. I also was involved in the
10 development of surveys of smoking behavior for the
11 National Clearinghouse, and I worked on a number of
12 health education projects for the Bureau of Health
13 Education.
14 Q. We've been wrapped up in this case so long that
15 we probably don't want to hear more about the Surgeon
16 General, but for the Court's benefit, when people refer
17 to the Surgeon General, what exactly is that office?
18 A. The Surgeon General -- It is commonly referred to
19 as the Surgeon General of the Public Health Service.
20 Each service, the Army, Navy and Air Force as well as
21 the Public Health Service has a Surgeon General. The
22 Surgeon General of the Public Health Service supervises
23 the agencies of the Public Health Service, and has come
24 to be the public spokesperson or family physician, if
27
1 you will, of the United States. He or she is commonly
2 the person we turn to to get advice on risks, on various
3 health behaviors, health changes that are important to
4 the American public.
5 Q. Is it fair to call the Surgeon General the family
6 physician for the United States?
7 A. Yes. I think that is an accurate
8 characterization of the role that physician plays.
9 Q. Likewise, we've heard a lot of discussion about
10 the Surgeon General Reports and the various volumes of
11 that. Why don't you tell the Court exactly what the
12 Surgeon General Reports are and how they came to be.
13 A. Well, the Surgeon General's Reports are a
14 comprehensive review of the published, the world's
15 published literature on smoking and health. They
16 evolved over time. The very first report was not a
17 report of the Surgeon General but rather a report to the
18 Surgeon General by an expert committee. Following that
19 report, the legislation was passed by Congress mandating
20 that there be an Annual Report to Congress that
21 synthesized the existing evidence on smoking and health.
22 So for a series of years, the report consisted of a
23 review of one year's worth of scientific literature,
24 everything that had been published. It was then
28
1 distilled down and presented as a volume. The volume
2 usually took on one additional topic as a special
3 chapter.
4 Q. Let me stop you right there. The first Surgeon
5 General's Report came out in what year?
6 A. The first Surgeon General's Report came out in
7 1964.
8 Q. Now, prior to 1964, had the Surgeon General taken
9 a position on whether or not smoking caused disease?
10 A. Yes, he had.
11 Q. What was that position?
12 A. In 1959, the Surgeon General at that time,
13 Surgeon General Burney, published an article saying that
14 smoking was a cause of lung cancer.
15 Q. And when the first Surgeon General's Report came
16 out in 1964, what was the motivation, the reason and the
17 purpose for it?
18 A. Well, the period of the mid 1950s was the period
19 where the scientific community identified and concluded
20 that smoking caused lung cancer. There was a response
21 by the tobacco industry at that time with a substantial
22 media and disinformation campaign that questioned
23 whether the scientific community had reached that
24 conclusion and questioned the validity of a great many
29
1 of the scientific studies that had been published. They
2 articulated that both to the press and to the Congress.
3 As a result, in 1962, President Kennedy requested of the
4 Surgeon General that he convene an expert committee to
5 review all of this evidence and reach a judgment. That
6 expert committee was selected from individuals who had
7 no prior public position on whether smoking caused
8 disease. That list was provided both to the tobacco
9 industry and to the public health community, and they
10 were allowed to veto any name on the list for any reason
11 without question. No one did. And that group then
12 convened and met for about thirteen months, reviewing
13 all of the existing evidence, interacting with one
14 another, synthesizing that evidence, and finally
15 reaching a judgment that was summarized in the 1964
16 report, and the judgment included the statement that
17 cigarette smoking was a cause of lung cancer.
18 Q. You've described the comprehensive nature of
19 these reports. For the Court's benefit, why don't you
20 tell us a little bit about the process that one has to
21 go through from the time that it is decided they're
22 going to issue a report to the time that it comes out
23 and goes out to the public?
24 A. It is important to recognize that these reports
30
1 represent the official position of the U.S. Public
2 Health Service and represent the consensus of scientific
3 thought at that point in time. As a result, they go
4 through a very careful process to ensure that individual
5 biases are not determining conclusions or the statements
6 within the volume. In the last couple of decades, the
7 way that they have been prepared has been individuals
8 are asked to draft sections of chapters or chapters.
9 Those individuals are scientists and are usually outside
10 of the government who are extensively knowledgeable in
11 the specific area that they are asked to write about.
12 Those drafts are received by the editors and edited into
13 chapters. The chapters are then sent out to another
14 group of individuals who are experts in the content area
15 of that chapter. They provide a review of that
16 individual chapter. It looks at its accuracy, its
17 balance, its tone and whether the data in it support the
18 conclusions and whether all of the data that should be
19 included are included. That is sent back to the
20 editors. The authors never again interact with the text
21 that they have written. The editors integrate the
22 comments, and the entire volume is combined and sent out
23 to a large group of experts broadly knowledgeable in
24 tobacco. They review the entire volume for its balance,
31
1 its tone, its conclusions, whether the conclusions are
2 presented by the data presented, whether the volume is
3 complete in terms of the science that it presents, and
4 whether that science is presented fairly and in an
5 unbiased fashion. Those comments are once again
6 integrated by the editors, and then the volume is
7 submitted for formal review by each agency of the Public
8 Health Service. The scientists within those agencies
9 review the document and once again feed back that
10 information to the editors, and those comments are
11 integrated into the volume again to strengthen the text
12 and the science. Once that has happened, it is then
13 submitted for formal clearance by the Centers for
14 Disease Control, by the Assistant Secretary for Health
15 and the Surgeon General, and then by the Secretary of
16 Health and Human Services. Once it is cleared, it is
17 transmitted as a formal requirement of the law to the
18 U.S. Congress.
19 Q. Okay. You've told us about the process. Now
20 tell me a little bit about how long this process takes
21 typically.
22 A. In the first --
23 Q. The question was how long does this process take?
24 A. In the first fifteen years or so, that process
32
1 was accomplished within about a one-year interval. Over
2 the last decade or the last fifteen years, perhaps,
3 given the vast expansion in that body of literature, it
4 has required two to three years to accomplish that task.
5 Q. You told us earlier why it was necessary for the
6 1964 report to be issued by the Surgeon General. Could
7 we have CKT900189 up on the screen, please?
8 And my question to you is why was it necessary
9 for the Federal Government to get involved and take a
10 leadership position in this research?
11 MR. LOMBARDI: Your Honor, I'm not sure where
12 this is going, but my objection is that this appears to
13 be something that gets into personal injuries, physical
14 effects on people who smoke, which as you know is not an
15 issue in this lawsuit. This is a Consumer Fraud Act
16 claim. And apparently we're going to talk about the
17 number of deaths per year that are estimated to occur
18 due to smoking. It is not relevant to this case. There
19 is no death at issue in this case. There is no physical
20 injury at issue in this case. And so I object to the
21 exhibit, and I object to any testimony going forward on
22 the basis of this exhibit.
23 MR. ZELCS: Your Honor, we're simply tying up the
24 background of both the Surgeon General Reports and
33
1 ultimately the monographs which Dr. Burns has been
2 involved in, and Monograph 13 has been admitted in this
3 case.
4 THE COURT: Overruled.
5 MR. LOMBARDI: Did you give an exhibit number?
6 MR. ZELCS: The exhibit number is 55.
7 Q. The question to you again is why was it necessary
8 for the Federal Government to take a leadership role in
9 this research?
10 A. Well, it was necessary for the Federal Government
11 to take a leadership role because of the magnitude of
12 this problem. Lung cancer has gone from a disease at
13 the turn of the century that was essentially unknown and
14 one of the rarest of human diseases to now being the
15 largest cause of cancer death of men and women. There
16 are some 430,000 deaths caused by cigarette smoking each
17 year. That is about one out of every five deaths that
18 occur in the United States, and they are attributable to
19 a single agent. Given the magnitude of the death and
20 disability produced by cigarette smoking, it would be
21 irresponsible for the Federal Government not to become
22 involved in trying to reduce that degree of damage and
23 injury.
24 MR. LOMBARDI: Your Honor, same objection. I
34
1 move to strike on the same grounds. And if this is
2 going to continue, may I have a continuing or standing
3 objection on these grounds for this line of questioning?
4 MR. ZELCS: It is still part of what the Surgeon
5 General Reports and the monographs are all about and the
6 issues that are discussed. We're just tying it all in.
7 MR. TILLERY: We'll agree to a standing
8 objection.
9 THE COURT: All right. There will be a standing
10 objection. Overruled. Standing objection.
11 Q. Are you familiar with the various diseases that
12 research has shown are caused by smoking?
13 A. Yes, I am.
14 Q. And have you asked us to prepare a diagram that
15 demonstrates, a schematic that demonstrates those
16 diseases?
17 A. Yes, I have.
5 Q. If you would, in whatever way you deem
6 appropriate, walk the Court through the different types
7 of diseases that smoking causes.
8 A. Well, that is partial list of the diseases that
9 smoking causes. It includes cancers, heart disease,
10 cardiovascular diseases and respiratory diseases.
11 Q. What would be the first disease that you would
12 like to talk about?
13 A. The first disease is cancer of the lip.
14 Cigarette smoke is one of the most prolific carcinogens
15 present in society, and it causes cancer in every organ
16 that it touches directly. In this case, it is the lip.
17 The next is the tongue, the mouth, the larynx, the
18 esophagus, the bronchus, and lung. So any of the organs
19 that it touches directly, it causes cancer. When it
20 gets into the lung, it is also absorbed. When it is
21 absorbed, it causes cancer in those expiratory organs
22 that deal with many of the metabolic carcinogens that
23 have been activated by the liver. They include cancer
24 of the pancreas, cancer of the kidney, and cancer of the
37
1 bladder.
2 Having absorbed the carcinogens, there are a
3 number of other agents in tobacco smoke, particularly
4 carbon monoxide, that damage the vascular system. And
5 of the blood vessels that are damaged are the heart, the
6 cerebral vessels -- that is, the vessels leading up to
7 the brain, causing stroke -- the aorta -- aortic
8 aneurysms -- and, in this case, peripheral vascular
9 disease, which is the blood vessels that go to the lower
10 extremity. They become clogged and cause pain and
11 ultimately amputation to the lower extremities. In
12 addition, the obstruction within the lung is accompanied
13 by deposition in the lung of a number of very irritating
14 substances that cause inflammation in the breathing
15 tubes of the lung, the bronchi, and it also causes
16 damage to the lung structure itself, that is, emphysema,
17 where the alveoli, the small grape-like structures where
18 gas exchange actually occurs. The walls of those
19 alveoli become disrupted and ruptured, creating very
20 large, open empty sacs within the lung. They function
21 very poorly for gas exchange, causing what is called
22 chronic obstructive lung disease where the individual
23 has difficulty blowing air out and, therefore, has
24 difficulty getting enough oxygen in and carbon dioxide
38
1 out, that being the principal function of the lung.
2 Q. Have we covered all of the items that you have in
3 your chart?
4 A. Yes.
5 Q. Let's go back to the Surgeon General's Report if
6 we can. Are the people that work on the Surgeon
7 General's Report invited to do so or how do they get
8 chosen?
9 A. Yes. They get selected. Both the editors are
10 invited, as well as the authors and reviewers are all
11 invited.
12 Q. Are the reviewers paid?
13 A. No. All of the reviewers provide that service
14 voluntarily because of the importance of this volume for
15 public health.
16 Q. The invitation of the selections to work on the
17 Surgeon General's Report, what are they based on?
18 A. They're based on the scientific knowledge and
19 stature of the individual, and the individuals are
20 selected because of their record of publishing and being
21 broadly knowledgeable on the specific issues that the
22 report is covering.
23 Q. Now, you told us earlier about your involvement
24 with the '75 report, the '76 report while you were at
39
1 the Clearinghouse in Atlanta, right?
2 A. That's correct.
3 Q. Have you continued to maintain involvement with
4 the Surgeon General Reports since that time?
5 A. Yes. I have been an author, editor or senior
6 reviewer of every Surgeon General's Report that's been
7 produced since 1975.
8 Q. Could I have 900328 on the screen, please? Thank
9 you. With regard to the 1975 report, what were your
10 responsibilities?
11 A. My responsibility at that time was to write the
12 1975 report. I authored all of the sections of that
13 volume.
14 Q. With regard to the 1979 report, what role did you
15 have?
16 A. I was an author of two of the chapters in the '79
17 report, and I was one of three editors for that volume.
18 Q. In 1980, what role did you have in that report?
19 A. In 1980, I was one of the three associate
20 scientific editors for the volume.
21 Q. In 1981, what role did you have in that report?
22 A. I was responsible for the section on lung disease
23 in that report, and I was also responsible for -- as one
24 of the three consulting scientific editors for the
40
1 volume.
2 Q. In '82, what role did you have in that report?
3 A. Again, I was one of the associate scientific
4 editors for that report.
5 Q. In '83, what role did you have in that report?
6 A. That report was on cardiovascular disease, and I
7 was one of the three associate editors for that volume.
8 Q. Now, as the 1984 report was being prepared, did
9 you have a change in your position with the Surgeon
10 General's Reports?
11 A. Yes. I did. I became senior scientific editor
12 for those volumes.
13 Q. In 1984, in addition to being the senior
14 scientific editor, what was your role in that report?
15 A. That report is on chronic obstructive lung
16 disease. I was the senior scientific editor for that
17 volume, which means I helped draft the outline for the
18 content of the report and consulted with the office on
19 smoking and health to select the authors and reviewers
20 for the volume, and I was also the single individual
21 responsible for the scientific content and validity of
22 the volume.
23 Q. The 1985 report, what did you do with regard to
24 that?
41
1 A. The 1985 report covered cancer and chronic lung
2 disease in the workplace and the interactions of smoking
3 with occupational exposures. That report, I was the
4 senior scientific editor for that report as well.
5 Q. Tell us what your role was in the 1986 report.
6 A. The 1986 report was on involuntary smoking or
7 environmental tobacco smoke exposure. Again, I was the
8 senior scientific editor for that volume.
9 Q. In the past, who have been some of your
10 colleagues as scientific editors for these Surgeon
11 General Reports?
12 A. There are a large number of distinguished
13 scientists who have served in that role. They include
14 Jack Henningfield, Neal Benowitz, Jonathan Samet, and a
15 variety of other distinguished individuals.
16 Q. Since 1976, have you continued to contribute to
17 the Surgeon General Reports?
18 A. Yes. I have been one of the senior reviewers for
19 each of the volumes subsequent.
20 Q. Let's go through the volumes where you've served
21 in that capacity from 1988 up until the present day. In
22 1988, what was your role?
23 A. The 1988 report is on nicotine addiction, and I
24 was one of three senior reviewers for that volume.
42
1 Q. 1989?
2 A. The 1989 report was a review of twenty-five years
3 worth of public health and tobacco control efforts, and
4 I was also a senior reviewer for that volume.
5 Q. 1990?
6 A. 1990 focused on smoke cessation and the disease
7 risk reduction that occurs with smoking cessation. I
8 was a senior reviewer for that volume.
9 Q. 1994?
10 A. 1994, I discussed smoking and health in the
11 Americas, that is, in Latin America and Central America.
12 I was a senior reviewer for that volume.
13 Q. 1998?
14 A. Well, 1994, which is the one that you put up, is
15 on the impacts on young people, adolescents. I was a
16 senior reviewer for that volume. In 1998, the report
17 was -- This is one on youth. In 1998, the report was on
18 racial and ethnic minorities, smoking behaviors and the
19 disease consequences.
20 Q. Bear with us. We don't know these as well as you
21 do. I apologize if we're stumbling through this. The
22 2000 report, what was that?
23 A. The 2000 was a review on the interventions that
24 work to reduce smoking behavior. I was a senior
43
1 reviewer for that volume.
2 Q. How about the 2001 Surgeon General's Report?
3 What was your involvement there
4 A. That was as report that once again revisited the
5 issues of disease consequences of smoking for women, and
6 I was senior reviewer for that volume.
7 Q. You mentioned earlier that one of your more
8 treasured awards was the Surgeon General's Medallion.
9 Who have been some of the other recipients of the
10 Surgeon General's Medallion?
11 A. Joseph Cullen, Tom Houston, Jack Henningfield,
12 Neal Benowitz, Donald Shopland, among others, Ron Davis.
13 Q. Let's go back and focus on your work as a senior
14 reviewer for the Surgeon General Reports, 1986 until the
15 present. What exactly were your responsibilities in
16 that role?
17 A. Well, what happens is as a senior reviewer,
18 you're provided the entire volume, all of the chapters.
19 You then read through the entire volume and provide a
20 critique of the individual sections of that volume.
21 Your specific responsibilities are to focus on the
22 issues of whether the science that is presented is
23 complete, whether the conclusions drawn represent the
24 consensus of scientific thought, whether they are based
44
1 on the information presented in the volume, and whether
2 the balance and tone of the discussion of the science as
3 well as the conclusions is consistent with the consensus
4 of scientific thought.
5 Q. Why is the process even utilized?
6 A. Well, because this is a very serious public
7 health issue, and it is quite important to get the
8 science accurate. And this also represents the official
9 position of the U.S. Public Health Service and,
10 therefore, the U.S. Government. And we take great pains
11 to then make sure that the information represents the
12 true consensus of scientific thought, not the
13 perspective of a single individual who may have a biased
14 approach to a given topic.
15 Q. You've told us before, I think, that these
16 reviewers aren't paid; is that right?
17 A. That's correct.
18 Q. Tell us how they're selected.
19 A. They're selected by the Office of Smoking and
20 Health based on their publications and their knowledge
21 about smoking and health issues and specifically around
22 those smoke and health issues that are being focused on
23 in that given year.
24 Q. Now, let's get away from the Surgeon General
45
1 Reports for just a second. Let me ask you this. Are
2 you familiar with what is described as a peer reviewed
3 publication?
4 A. Yes, I am.
5 Q. Tell us what is involved in that process, a peer
6 reviewed publication.
7 A. Normally with a peer review for a journal, an
8 article is sent into the journal, the editor looks at
9 the topic and sends it out to two or three scientists
10 who are knowledgeable in that area. They write a review
11 or critique and send it back to the editor. That editor
12 then either accepts it, rejects it or sends it back to
13 the author for revision, but the author is always in
14 control of the document. At that point in time, the
15 author revises it and sends it back into the editor, and
16 it is published. So there is in general only one level
17 of review most of the time, and the author is always in
18 control of the document.
19 Q. Okay. Now, let's go back to the Surgeon
20 General's Report. Is the review process that you have
21 told the Court for that document, is that also what you
22 would describe as peer reviewed?
23 A. Definitely. It is among the most comprehensive
24 peer reviewed processes of any document that I am
46
1 familiar with.
2 Q. Is the review process for the Surgeon General
3 Reports more rigorous, more robust than just the
4 ordinary peer review that you have been telling us
5 about?
6 A. Absolutely. It is much more robust both in terms
7 of the objectivity and in terms of the extensiveness.
8 It is three different layers of review. The review is
9 conducted by a larger number of individuals at each
10 layer, and the author of the individual sections does
11 not get to incorporate the changes suggested by the
12 reviewers. That is done by the editors rather than the
13 individual author. It is a much more objective process,
14 and it is one that is much more robust in terms of its
15 scope and the number of individuals involved.
16 Q. You've had involvement with peer reviewed
17 publications outside of the context of the Surgeon
18 General's Report?
19 A. Absolutely. Sure.
20 Q. Now, other than the Surgeon General Reports, does
21 the Federal Government also from time to time issue
22 something that is called a monograph on various smoking
23 and health issues?
24 A. Yes. The National Cancer Institute has produced
47
1 a series of tobacco monographs.
2 Q. And to date, how many of these monographs have
3 been issued?
4 A. Fourteen have been issued, and fifteen is being
5 ready for release.
6 Q. If you would, tell the Court what involvement you
7 have had with these monographs.
8 A. I have been senior editor for nine of those
9 monographs.
10 Q. Why don't we go through those. I guess we're
11 going through them right now. Can we go back to
12 Monograph 1, please?
24 Q. I was asking you about your involvement in the
48
1 fourteen monographs that have been issued to date.
2 Could you repeat that for us so we can get back in sync?
3 A. Right. I was the senior editor for eight of
4 those fourteen and also for the fifteenth that will come
5 out shortly.
6 Q. We've got them all listed there. Let me ask you
7 this question: Is there any difference between the
8 process that you have been telling the Court about with
9 regard to putting together the Surgeon General Reports
10 and that for putting together the National Cancer
11 Institute's monographs?
12 A. There are similarities and differences. The
13 similarities include the fact that it is a three-layered
14 review, going through chapters, the entire volume, and
15 then clearance through the National Cancer Institute and
16 review at that point. One of the differences is that
17 the authors of the individual sections are indeed
18 involved in the process of integrating their comments.
19 Q. Could we highlight Monograph 13 or bring it up?
20 Have any of the monographs dealt with the disease risks
21 from low tar or light cigarettes?
22 A. Yes. Monograph 13 dealt with the risks
23 associated with smoking cigarettes with low machine
24 measured yields of tar and nicotine.
49
1 Q. What was your role in Monograph 13?
2 A. I authored two of the chapters, and I was the
3 senior -- I was one of two editors for that volume.
4 MR. ZELCS: Your Honor, at this time I would like
5 to offer Dr. David Burns as an expert in the area of
6 disease risk of tobacco products and especially with
7 regard to light cigarettes.
8 THE COURT: Counsel for the defendant?
9 MR. LOMBARDI: No objection.
10 THE COURT: All right. He'll be so interpreted.
11 Q. When was Monograph 13 published?
12 A. It was published in November of 2001.
13 Q. This would have been during the Busch
14 Administration?
15 A. Yes.
16 Q. What was the purpose of Monograph 13? Why was it
17 prepared?
18 A. The Federal Trade Commission reports measurements
19 of tar and nicotine values using a specific protocol and
20 mandates that those values be included in tobacco
21 advertising. There had been considerable concern in the
22 public health community that the information provided
23 was not one -- that the information provided was being
24 inaccurately interpreted, that its original purpose,
50
1 that is, a purpose of measuring the difference in
2 disease risks of different cigarettes, was not valid,
3 that the light and low and low in tar cigarettes were
4 indeed not less risky. That concern grew, and the FTC
5 was receiving substantial criticism for its continued
6 maintenance of the FTC method of generating tar and
7 nicotine. Therefore, they requested from the Food and
8 Drug Administration and the National Cancer Institute
9 comprehensive review of the science to determine whether
10 or not the evidence supported a reduction in disease
11 risks associated with low tar and nicotine cigarettes.
12 Q. When were you first approached to participate in
13 this monograph?
14 A. I don't have the exact day in memory, but my
15 recall is it was sometime around 1998. Representatives
16 of the National Cancer Institute and the Food and Drug
17 Administration approached me and asked me if I would
18 edit that review along with Dr. Neal Benowitz.
19 Q. Could we have M1, Pages DI and DII? Could we go
20 back to the first one? Kind of blurry, isn't it?
21 A. It is. It is beyond the resolution of my eyes at
22 this point.
23 Q. Let's go back yet another page, if we can. One
24 more. Back. We're getting there. One more. I think
51
1 you're going in the wrong direction. Why don't we go to
2 the first page of the monograph that lists the editors
3 and authors of the initial chapters, if we can. If not,
4 we can work our way through it. Very good. We'll start
5 here. You were there awhile ago, and I didn't pick up
6 on it. I apologize.
7 Let me ask you this question after all of that.
8 Who were some of the other scientists that were involved
9 in Monograph 13?
10 A. There were a number of other distinguished
11 scientists. Neal Benowitz was the co-editor with me.
12 Lynn Kozlowski was involved. Dietrich Hoffman was
13 involved. Dr. Cohen was involved. Rick Pollay, who is
14 an expert in media, was involved. And all of them
15 contributed to various sections of the volume.
16 Q. Were these people considered the leading
17 scientists in the United States and the world in this
18 area of smoking and health?
19 A. Yes. That's why we selected them.
20 Q. Let's talk about that a little bit for the Court,
21 if you would. Who was it that selected these people?
22 Who selected you?
23 A. The Food and Drug Administration and the National
24 Cancer Institute selected me and also selected
52
1 Dr. Benowitz to be the editors of the volume.
2 Q. Who selected the other authors that are on that
3 somewhat blurry overhead?
4 A. The National Cancer Institute selected the
5 others. They were selected obviously in consultation
6 with myself and Dr. Benowitz.
7 Q. I take it that there were drafts that were
8 prepared of the monograph, right?
9 A. Yes, there were.
10 Q. How are the drafts edited? Who edited them?
11 A. Well, as is true of all manuscripts, they go
12 through innumerable drafts within the person who authors
13 the first section. In a multi-authored section, they're
14 then sent to the other authors. There is then another
15 series of interactions around those drafts where they're
16 modified and incorporated in different perspectives of
17 the different authors, and then they are sent to the
18 reviewers for review. Those comments are again
19 integrated back, and it is combined into a single volume
20 and sent out again for review. The second level of
21 review again comes back. Those comments are integrated.
22 When the final volume is produced, it is sent to the
23 National Cancer Institute. It undergoes another review.
24 In the instance of Monograph 13, that was an extensive
53
1 internal review. There were multiple interactions with
2 the National Cancer Institute. Again, comments were
3 incorporated, changes were made in the volume to improve
4 its quality, and then it was released.
5 Q. Each of the chapters in Monograph 13 had
6 conclusions that were developed by the authors; is that
7 correct?
8 A. That's correct.
9 Q. There were conclusions that were developed for
10 both Chapter 1 and Chapter 4 which you authored,
11 correct?
12 A. That's correct.
13 Q. Could I have CKT015897? Thank you.
14 What is up on the screen right now, the
15 conclusions to which chapter?
16 A. These are the conclusions for Chapter 1.
17 Q. Would you go through those for the Court?
18 A. Chapter 1 is the overall summary chapter for the
19 rest of the volume. The first conclusion is that
20 epidemiologic and other scientific evidence, including
21 patterns of mortality from smoke-caused diseases, does
22 not indicate a benefit to public health from changes in
23 cigarette design and manufacturing over the last fifty
24 years.
54
1 The second is that for spontaneous brand
2 switchers, there appears to be a complete compensation
3 for nicotine delivery, reflecting more intensive smoking
4 of lower-yield cigarettes.
5 The third is that widespread adoption of lower
6 yield cigarettes in the United States has not prevented
7 the sustained increase in lung cancer among older
8 smokers.
9 Many smokers switch to lower yield cigarettes out
10 of concern for their health, believing these cigarettes
11 to be less risky and to be a step toward quitting.
12 Advertising and marketing of lower yield cigarettes may
13 promote initiation and impede cessation, more important
14 determinants of smoking-related diseases.
15 Number five, measurements of tar and nicotine
16 yields using the FTC method do not offer smokers
17 meaningful information on the amount of tar and nicotine
18 they will receive from a cigarette. The measurements
19 also do not offer meaningful information on the relative
20 amounts of tar and nicotine exposure likely to be
21 received from smoking different brands of cigarettes.
15 MR. ZELCS: Could I have the conclusions for
16 Chapter 4? That would be CKT016023, please. Dr. Burns,
17 what are those?
18 A. These are the six conclusions from Chapter 4
19 which assesses or examines the disease risks from
20 smoking cigarettes with low machine yields.
21 Q. You were a co-author of that chapter?
22 A. Yes, I was.
23 Q. Would you go through these conclusions for the
24 Court, please?
57
1 A. Yes. Conclusion number one is changes in
2 cigarette design and manufacturing over the last fifty
3 years have substantially lowered the sales-weighted,
4 machine-measured tar and nicotine yields of cigarettes
5 smoked in the United States.
6 Number two, cigarettes with low machine-measured
7 yields by the FTC method are designed to allow
8 compensatory smoking behaviors that enable a smoker to
9 derive a wide range of tar and nicotine yields from the
10 same brand, offsetting much of the theoretical benefit
11 of a reduced-yield cigarette.
12 Number three, existing disease risk data do not
13 support making a recommendation that smokers switch
14 cigarette brands. The recommendation that individuals
15 who cannot stop smoking should switch to low yield
16 cigarettes can cause harm if it misleads smokers to
17 postpone serious efforts at cessation.
18 Number four, widespread adoption of lower yield
19 cigarettes by smokers in the United States has not
20 prevented the sustained increase in lung cancer among
21 older smokers.
22 Number five, epidemiologic studies have not
23 consistently found lesser risk of disease, other than
24 lung cancer, among smokers of rude yield cigarettes.
58
1 Some studies have found lesser risks of lung cancer
2 among smokers of reduced yield cigarettes. Some or all
3 of this reduction in lung cancer risk may reflect
4 differing characteristics of smokers of reduced-yield
5 compared to higher-yield cigarettes.
6 Number six, there is no convincing evidence that
7 changes in cigarette design between 1950 and the mid
8 1980s have resulted in an important decrease in the
9 disease burden caused by cigarette use either for
10 smokers as a group or for the whole population.
11 Q. These conclusions were shared by the authors of
12 Monograph 13; is that correct?
13 A. These conclusions were specifically signed off by
14 all of the authors of this chapter and also by the
15 National Cancer Institute.
16 Q. How did you get all of these famous scientists to
17 sign off on the conclusions of Monograph 13? How did
18 that work?
19 A. Well, as with many consensus statements, it was a
20 reiterative process. Language was written, individuals
21 responded to that language, made suggestions for
22 alternatives, raised concerns, expressed ideas, explored
23 issues, and over time, and in this case it was the
24 better part of about a year, these conclusions emerged
59
1 as the consensus.
2 Q. These conclusions that you have discussed with
3 the Court, do you have an opinion within a reasonable
4 degree of scientific certainty whether these conclusions
5 represent the consensus view of the scientific community
6 as of the time that Monograph 13 was published?
7 A. Yes, I do.
60
1 Q. What is your opinion, sir?
2 A. That it does indeed represent the consensus of
3 the scientific community on this issue.
4 Q. Now, let's go back. You told us what the
5 conclusions are. You told us that people agreed. You
6 told us it is the consensus. Let's take a step back.
7 These particular conclusions, once they were reached,
8 was that a surprise to you?
9 A. It wasn't a surprise at that point in time.
10 Q. Why is that?
11 A. Concern on my part and on many other scientists'
12 part had been emerging since the mid 1990s. That was
13 emerging for a variety of reasons, including the fact
14 that we had expected that there would be a reduction in
15 disease, expected a reduction in lung cancer to occur
16 because beginning in the 1950s, people had switched
17 tremendously, more than sixty percent of the population
18 had switched to smoking filter cigarettes and were
19 smoking cigarettes with lower yields. By the 1980s,
20 there was a sixty percent reduction in the
21 machine-measured tar and nicotine yields. And we
22 thought in the 1970s, 1980s and early 1990s that that
23 ought to produce a reduction in lung cancer, and we kept
24 waiting to see it happen, and it never did. A second
61
1 line of evidence emerged that when studies were done at
2 two points in time, a time when high tar and nicotine
3 cigarettes were available and more recently when low tar
4 and nicotine cigarettes were the ones that were being
5 used, what we saw was not a reduction in the risk of
6 smoking but actually an increase. That occurred in
7 studies both here and in the United Kingdom. Those two
8 lines of evidence made us concerned that the prior
9 recommendations and the prior evidence were not valid.
10 In the mid 1990s, we began to get access to internal
11 tobacco industry documents that demonstrated how the
12 cigarettes were actually designed and what testing was
13 done on those products. And that filled in the missing
14 link. The premise on to which low tar and nicotine
15 cigarettes reduce disease risk is that the smoker will
16 actually get less tar when they use those products.
17 That had been what the expectation was. When we looked
18 at the internal tobacco industry documents, we were able
19 to understand that these cigarettes had been designed
20 specifically to produce a low level when measured by
21 machine but to have an elasticity of delivery when they
22 were smoked by individual smokers. That is --
11 A. The internal tobacco industry documents
12 demonstrate the design characteristics, the design
13 intent for developing these products, the testing that
14 was done, the conditions under which they were tested,
15 and the results of that testing demonstrate that what
16 was happening was that cigarettes were intentionally
17 being designed to vary the yield when smoked
18 differently, and that the reason for that was to satisfy
19 the nicotine ingestion required by individual smokers.
20 So that the product could produce a very low level when
21 smoked by machine, but when smoked by the individual,
22 the individual could derive from that cigarette as much
23 nicotine as they needed to satisfy their addiction. So
24 that piece filled in this missing link that allowed us
63
1 to bridge what had been a confusing conflict in the
2 scientific evidence, that some of the epidemiologic
3 studies showed a reduction in disease risk whereas we
4 didn't see that when we looked at populations, and we
5 didn't see that when we looked at different groups
6 examined at different points in time. So all of that
7 accumulated over the late 1990s, and we then were asked
8 to review all of that evidence in total. And when you
9 look at what we know about the cigarette, what we know
10 about addiction, and what we know about compensation,
11 what we know about the epidemiologic data, and what we
12 know about disease risks, we were able to reach the
13 conclusion that there is not evidence that establishes
14 any benefit to these products, and, indeed, there is
15 some evidence that suggests that the products may be
16 more hazardous.
4 Q. Were these industry documents that you reviewed
5 as part of your work on Monograph 13 and also as part of
6 your work in this case?
7 A. Yes.
8 Q. And based upon your review of those documents,
9 you're giving us your interpretation of the information
10 that was available to Philip Morris based upon what was
11 in those documents, correct?
12 A. Yes. Specifically, what I am giving you is my
13 understanding that when an experiment is conducted, that
14 examines conditions that are similar to the way a
15 cigarette is smoked in real life but dissimilar to the
16 way the cigarette is smoked by the FTC method. Those
17 differences lay the understanding of the characteristics
18 being sought in the engineering studies being conducted.
19 That is the design intent of that process.
20 Q. And the answer that you gave that Mr. Lombardi is
21 objecting to is based upon your review of those
22 documents as part of your work on Monograph 13, correct?
23 A. Yes, it is.
23 Q. Let me follow up and clarify this point a little
24 further. Did the publication of Monograph 13 include a
69
1 review of these Philip Morris documents, the industry
2 documents that you referred to?
3 A. Yes, it did.
4 Q. And the conclusions that you went through with
5 the Court earlier for Chapters 1 and 4 as well as the
6 rest of the chapters, are they based in part on a review
7 of those documents?
8 A. Yes. They include information that came from
9 that review.
10 Q. And isn't in fact the review of those documents
11 mentioned in the preface for Monograph 13 as being a
12 basis for this publication?
13 THE COURT: Just for the Record, do you want to
14 quote that?
15 MR. ZELCS: Page 1.
16 THE COURT: I'll pick this up on the transcript.
17 Just read it.
18 Q. Let me show the witness Monograph 13. It's been
19 previously admitted. Let me direct your attention to
20 the bottom of Page 1, the Preface. And could you read
21 the relevant language into the record, sir?
22 A. "This monograph is unique in another important
23 aspect. For the first time, the authors who have
24 prepared the various chapters have had extensive access
70
1 to the information gleaned from the internal documents
2 of the tobacco companies. The tobacco industry files
3 that are open to the public and available on the
4 internet constitute some 33 million pages of formal and
5 informal memos, meeting notes, research papers and
6 similar corporate documents. Included are marketing
7 strategies that express the growing concern among the
8 various tobacco companies of the potential loss of new
9 recruits. This concern over the potential loss of
10 market was due to the evolving public opinion that
11 smoking is harmful to health and that it is related to
12 many of the illnesses that smokers experience over the
13 course of their lives."
14 MR. ZELCS: Thank you.
23 Q. Let's step back again a little bit. You talked
24 about the conflicting lines of evidence that were
71
1 reviewed, analyzed, and conclusions drawn. Let's go
2 back to some of that. You talked about earlier studies
3 that lead people to believe that there would be a
4 decrease?
5 A. Yes.
6 Q. All right. And are those epidemiological studies
7 that you're referring to?
8 A. Yes.
9 Q. When in time were the results of those studies
10 first reported?
11 A. Those studies were first reported in the 1970s
12 and the 1980s.
13 Q. And what was the response to those early
14 findings?
15 A. Well, the response was very, very encouraging.
16 Early data suggested that -- in the 1950s that
17 cigarettes caused cancer, that the risk of cancer
18 related to the number of cigarettes that were smoked.
19 And then tar, the particulate matter of smoke, when
20 painted on the backs of animals was shown to cause
21 cancer. It is then a logical inference, and one that is
22 probably still true today, that if you reduce the amount
23 of tar that people were exposed to that they would get
24 less cancer. So early studies were done, and lo and
72
1 behold we found that populations of individuals who used
2 these products had indeed less cancer than populations
3 of individuals who didn't. That lead us to be
4 enthusiastic about the prospect that this might be
5 another route to reduce the amount of lung cancer that
6 occurred in the United States among smokers.
7 Q. Did lung cancer death rates go down?
8 A. Lung cancer death rates in relation to cigarette
9 smoking did not go down. As a matter of fact, they
10 increased in relation to cigarette smoking. And lung
11 cancer rates in women are still rising. They have been
12 declining by men since 1990, but that decline is fully
13 explained by the cessation of cigarette smoking by adult
14 males.
15 Q. How do you explain the early epidemiological
16 findings in light of what you have seen in lung cancer
17 mortalities since that time?
18 A. Well, the missing link for us was understanding
19 the design characteristic of the cigarette and
20 understanding how that design characteristic
21 interrelated with the addiction and the impact of
22 addiction on behavior. The early studies show a
23 difference; however, they don't account for the fact
24 that people who use these products are different because
73
1 they are selecting a low tar and nicotine product,
2 someone who is choosing to use a product that is
3 advertised as less hazardous, as safer, that they are
4 told it is less hazardous.
5 Q. Let me interrupt you for a second. When you say
6 that the early findings can be explained by differences
7 between the smokers, explain to the Court exactly what
8 you're talking about.
9 A. All that epidemiologic study shows is that one
10 population of individuals has a different experience
11 with cancer than another population of individuals. And
12 the way you draw inference from that observation is to
13 try to control for various differences in the
14 population. When you have in a question that you are
15 asking, such as do low tar and nicotine cigarettes
16 influence the disease risk, you can't do an experiment
17 -- you can't randomly assign people to smoke the
18 cigarettes of one type or another, and so people
19 self-select. The people who select to use low tar and
20 nicotine cigarettes in general are more health
21 conscious, they're more concerned about their health.
22 Some of them in the early years were more likely to try
23 to quit, and they tend in general to be a healthier
24 group. Therefore, if you look at them separately, you
74
1 would expect to see a difference in disease risk.
2 The second problem is that people who try to
3 shift to lower tar and nicotine cigarettes, not
4 everybody may make it. If you have an individual who is
5 a very heavily addicted smoker, who needs very high
6 levels of nicotine to sustain their addiction and who is
7 smoking a high level of high tar and nicotine cigarettes
8 to get that nicotine, when they shift down to a lower
9 tar and nicotine cigarette, they may not be able to
10 successfully adapt. They may not be able to get from
11 that lower tar and nicotine cigarette enough nicotine to
12 satisfy their addiction without increasing their number
13 of cigarettes smoked from say two packs to four or five
14 packs. That becomes very expensive, very difficult, and
15 so the folks don't stay with those low tar and nicotine
16 cigarettes. So you then select out the population so
17 that the high tar and nicotine smokers tend to be more
18 addicted, more intensive smokers.
19 And the third characteristic that confused us and
20 that wound up being a problem is that when people switch
21 from a high tar cigarette to a low tar cigarette, they
22 compensate to preserve the amount of nicotine that
23 they're getting from the cigarette. One of the ways
24 that they compensate is by increasing the number of
75
1 cigarettes that you smoke per day. When the
2 epidemiologic studies have done it, they compare like
3 numbers of cigarettes per day. So if an individual who
4 is smoking twenty cigarettes per day high tar and
5 nicotine cigarettes switches to low tar and nicotine
6 cigarettes and gets exactly the same dose of tar and
7 nicotine but is now smoking twenty-five cigarettes to
8 get that dose, it will appear when you compare them to a
9 twenty-five cigarette per day high tar smoker as if
10 there is a risk reduction when in reality that
11 individual experienced it.
12 So those three general areas of confusion in
13 existing epidemiology had us puzzled for a very long
14 period of time until we were able to understand the role
15 that they played in confounding the epidemiologic
16 studies that have been published.
17 Q. Now, the explanation that you just gave the Court
18 reconciling these conflicts, was this also part of the
19 subject matter of Monograph 13?
20 A. Absolutely. It was one of the critical sections
21 in Chapter 4 where we discuss why the existing
22 epidemiology has limitations in examining behavior like
23 this, which is a self-selected behavior. People
24 self-select to smoke low tar and nicotine cigarettes.
76
1 Q. May we have the Sixty Minutes?
12 (Whereupon the following video clip was played in open
13 court.)
14 A VOICE: "A report on smoking said low tar
15 cigarettes might be less risky. It was a report edited
16 by Dr. David Burns."
17 A VOICE: "You know, Doctor, to my mind, one of
18 the tragedies here, you had physicians telling their
19 patients look, if you can't quit, smoke these."
20 A VOICE: "We were way behind the curve. We
21 didn't do enough research. We didn't do enough science
22 to find out what consequences those changes would have
23 had, and we should have been able to give better advice,
24 and we didn't, and a lot of people paid the price for
78
1 our error."
14 Q. When was that Sixty Minutes show broadcast in the
15 United States and Canada?
16 A. My recall is that it was the early part of 2001.
17 Q. Why did you make the decision to appear on that
18 television show?
22 Q. Did you feel any responsibility to tell the
23 American people about what you learned as a result of
24 the work involved in Monograph 13?
80
1 A. Yes.
3 A. In 1981, I was one of the editors of the Surgeon
4 General's Report. That report concluded that if you
5 couldn't quit, you were well-advised to switch to low
6 tar and nicotine cigarettes. Over the ensuing twenty
7 years, many people who were powerfully addicted,
8 struggling with that addiction, latched onto that
9 recommendation as a reason for not quitting. A review
10 that we conducted with Monograph 13 made it clear that
11 that recommendation was erroneous, that it was not based
12 on even the science that was available to the tobacco
13 industry but not to the public health community as of
14 1981. And, therefore, I felt a deep responsibility to
15 try and correct that recommendation and that
16 misinformation that had been provided by the Surgeon
17 General's Report to the American public.
16 Q. As we sit here today, do you have an opinion to a
17 reasonable degree of scientific certainty as to whether
18 Marlboro Lights and Cambridge Light cigarettes reduced
19 the risks associated with smoking compared to the
20 regular cigarettes for those who choose those products?
21 A. Yes, I do.
22 Q. What is that opinion?
23 A. There is no reduction in risk for the smokers who
24 choose those products.
83
1 Q. Let's step back again to Monograph 13, Chapter 4.
2 You're a co-author. Did Chapter 4 include any new
3 analyses?
4 A. Yes, it did.
5 Q. Tell us about the new analyses that were done in
6 Chapter 4.
7 A. There were four sets of new analyzes. We once
8 again reexamined the American Cancer Society CPS1 Study
9 to look at the relationship of tar to disease risk. We
10 examined the relationship in that study of people who
11 switched brands of cigarettes that had very different
12 nicotine yields as to what happened to their number of
13 cigarettes smoked per day. We did an analysis of the
14 California Tobacco Surveys to examine the relationship
15 between number of cigarettes smoked per day and the
16 nicotine yield of those cigarettes by the FTC method,
17 and we did an analysis that looked at smoking behaviors
18 in the United States, the risks that occur with those
19 behaviors, and the expected lung cancer risk that would
20 occur in the population. So those were four types of
21 analyses that we did for that volume.
22 Q. How significant a role did these analyses play in
23 the conclusions of Chapter 4?
24 A. They didn't play any significant role in the
84
1 conclusions. They simply were demonstrations on various
2 issues that we had raised as concerns or as issues in
3 the volume.
4 Q. Now, you're aware, Dr. Burns, are you not, that
5 the data underlying these new analyses in Chapter 4 has
6 been reviewed by others, including the defendant's
7 expert including Dr. Wecker in this case, and that in
8 his review he discovered a typographical error, correct?
6 Q. Have you come to learn that there is a
7 typographical error that was in the original analyses
8 that you just talked about?
9 A. Yes, I have.
10 Q. And have you corrected that typographical error?
11 A. Yes, I have.
12 Q. After correcting the typographical error, was
13 there any change in your interpretation of that
14 analyses?
15 A. No, there was not. There was a small change in
16 the mathematical values that were generated but no
17 change in interpretation of that data.
18 Q. After correcting the typographical error and
19 reviewing that data, did this change in any way any of
20 the opinions that you have drawn from this analysis?
21 A. No, it did not.
22 Q. Has your opinion changed in any way with regard
23 to the conclusions drawn in Chapter 4 as a result of any
24 of this additional review?
88
1 A. No, it has not.
2 Q. When did you first develop the opinion that
3 Marlboro Lights and Cambridge Lights weren't any better
4 for people?
4 A. The issue prioritized in my mind in the late
5 1990s relative to the science involved with these types
6 of cigarettes, the specific conclusion for those brands
7 of cigarettes for this class of individuals I made after
8 integrating the scientific information into the
9 understanding of this class of individuals.
10 Q. What specifically caused you to reach that
11 opinion?
14 A. Well, early on, we were operating from a dose
15 response understanding of the generation of cancer.
16 That is, if you receive less tar, you would get less
17 cancer. The early epidemiology showed that that effect
18 did, indeed, occur. By 1980 when we were looking at it
19 with the Surgeon General's Reports, we were concerned
20 because lung cancer rates were still climbing in males
21 and were still climbing rapidly in females, and we had
22 had these cigarettes available for over twenty years
23 with filters and for substantial reduction in tar and
24 nicotine for ten and more years, plenty of time for that
90
1 to have begun to occur. But the data that we had when I
2 was working with the 1981 Surgeon General's Report
3 suggested that the cigarettes still delivered less tar
4 and nicotine and the epidemiology was still there. And
5 while we were concerned, we felt that the science was
6 sufficient to draw a conclusion that these cigarettes
7 were less hazardous if people switched to them.
8 Subsequent to that, data was published that people
9 smoked specifically based upon their addiction, that the
10 amount of nicotine and amount of tobacco contained in a
11 low tar and nicotine cigarette was no less than the
12 amount of nicotine and the amount of tobacco in a higher
13 tar and nicotine cigarette, that when populations of
14 individuals were examined who smoked widely different
15 nicotine yields of cigarettes by the FTC method, the
16 amount of nicotine that they absorbed didn't appear to
17 differ by much if any at all. The understanding then
18 progressed through the mid 1990s to show that people
19 smoked low tar and nicotine cigarettes very differently.
20 They blocked the ventilation holes, they drew bigger
21 puffs from these cigarettes, they inhaled those puffs
22 more deeply, they took more puffs on the cigarettes, and
23 they took faster puffs. All of those changes increased
24 the tar and nicotine yield of the cigarettes that were
91
1 on the market as lower yield cigarettes. We then
2 developed the body of evidence that lung cancer in
3 individuals who were examined during the 1960s and
4 individuals who were examined during the 1980s, a period
5 of time during which the tar and nicotine yield of
6 cigarettes dropped by sixty percent, instead of going
7 down, those disease risks actually went up. And
8 finally, we obtained the information that these
9 cigarettes, when they were designed, were tested, and
10 the characteristics that they were tested for were ones
11 of blocking the holes and increasing the puff volume of
12 the cigarette, and the goal or the expectation that was
13 sought from those engineering changes was a cigarette
14 that when smoked differently would yield increasing
15 amounts of tar and nicotine to provide the smoker
16 whatever tar and nicotine yield they needed. At that
17 point in time, we now had an understanding of what was
18 going on scientifically, sufficient to reach a
19 conclusion that our early 1981 statement had been
20 erroneous because we did not understand the
21 characteristics of the cigarette and the relationship of
22 addiction and how people change their smoking pattern
23 based on addiction as it interacted with those design
24 characteristics. As we came to understand that people
92
1 fully compensated, we understood that they did not
2 receive less tar and less nicotine from light and
3 ultralight cigarettes, and, therefore, there was no
4 reason to expect a risk reduction. And that allowed us
5 to close the discrepancy between the existing
6 epidemiologic studies and what we had observed in
7 national death rates.
20 Q. Do you have any reason to believe the people
21 you're referring to in your answer are any different
22 than the class members in Illinois?
9 Q. Let's clarify one other thing for the Court if we
10 can. Monograph 13 is a compilation of research; is that
11 right?
12 A. That's correct.
13 Q. And it involved a large group of scientists from
14 throughout the United States and the world, right?
15 A. That's correct.
16 Q. And these scientists covered a wide variety of
17 disciplines, right?
18 A. Yes, they did.
19 Q. And the opinions that you have given today relied
20 upon the expertise of all of these scientists as
21 reflected in their work in Monograph 13, correct?
22 A. That's correct.
23 Q. Now, earlier we had --
24 THE COURT: Let me clarify further. The Court
94
1 further construes "people" within the context of
2 epidemiological studies.
3 MR. ZELCS: Thank you, Your Honor. May I
4 proceed?
5 THE COURT: I presume I'm correct on that.
6 A. Epidemiologic and other types of studies, yes.
7 THE COURT: Yes.
8 Q. Earlier on, we had what you would probably
9 describe as an animated conversation, at least so far
10 today, about documents. And were many of the documents
11 that were reviewed by you in Monograph 13 Philip Morris
12 documents?
13 A. Yes, they were.
14 MR. ZELCS: This has been marked as Group Exhibit
15 58.
16 Q. Dr. Burns, you've been handed a group exhibit,
17 Group Exhibit 58, consisting of a set of Philip Morris
18 documents. Can you identify those documents?
19 A. Yes. I believe that this is the set of documents
20 that I previously reviewed that are cited in Monograph
21 13.
22 Q. And those are documents that are actually
23 referred to either in footnotes or in other references
24 throughout Monograph 13 in the various chapters,
95
1 correct?
2 A. Yes, they are.
3 Q. These are the documents you were referring to
4 earlier in your testimony today; is that correct?
5 A. These are some of those documents. There are
6 obviously many of them.
7 Q. In terms of that group exhibit, is there one
8 document that crystallizes the information that became
9 newly available to you as a result of your review of
10 these materials?
11 A. Yes.
12 Q. Why don't you refer us to that.
13 A. That is a research study by Barbro Goodman --
14 Q. Could I ask for document -- Correct. Thank you.
15 A. -- dated September 17, 1975.
16 Q. And what was significant about that document to
17 you?
18 A. I believe that there are three things that are
19 powerfully significant in this document. The first is
20 the conclusion.
21 Q. Can we go to 113? Go ahead.
22 A. The conclusion of this document reads, "In
23 effect, the Marlboro 85 smokers in this study did not
24 achieve any reduction in smoke intake by smoking a
96
1 cigarette (Marlboro Lights) normally considered lower in
2 delivery. Conversely, the Marlboro Lights smokers did
3 not increase their smoke intake when they changed to the
4 regular delivery cigarette."
5 Q. What did you do with this information?
6 A. That information very clearly demonstrates that
7 in contrast to what we believed, six years later when we
8 wrote the 1981 Surgeon General's Report, smokers who
9 smoked brands of cigarettes on the market in 1975 were
10 not getting different yields when they smoked those
11 products. We believed they were.
12 And that leads to the second significant point,
13 which is that this is dated 1975, six years prior to the
14 time the Surgeon General's Report reached its
15 conclusion. And we did not have access to this
16 information or comparable information.
17 The third point is that this study was done on a
18 machine that mimicked actual smoking behaviors, that
19 actually matched the behavior of the individual when the
20 machine smoked the cigarette. In 1981, one of the
21 recommendations that we made as a research
22 recommendation was that that type of machine should be
23 developed so that we could develop a better
24 understanding of the relationship between delivery of
97
1 tar and nicotine of these cigarettes when they were
2 actually smoked. So, again, six years prior to the time
3 we were reviewing that evidence for the Surgeon General,
4 this information was available to Philip Morris.
17 Q. The first document in Group Exhibit 58 is the
18 memo from Barbro Goodman to Meyer, dated September 17,
19 1975; is that correct?
20 A. That's correct.
21 Q. And you just talked about that document; is that
22 right?
23 A. I have.
98
15 Q. Other than the publication of Monograph 13, have
16 any other government agencies, either in the United
17 States or abroad, reached similar conclusions?
7 A. The answer to your question for completeness is
8 yes.
9 MR. ZELCS: Thank you.
19 Q. Did you have any involvement with a panel created
20 by the Canadian Ministerial Council on Tobacco Control
21 with respect to descriptors?
22 A. Yes, I did. I was a member of that panel.
23 Q. And were you involved in findings and conclusions
24 that were made by that panel?
100
1 A. Yes, I was.
2 Q. Could I have CKT028287? Could you read for the
3 Court the finding on question one that that panel made?
4 A. Yes. The finding on question one: "There was no
5 convincing evidence of a meaningful health benefit to
6 either individuals nor to the whole population resulting
7 from cigarettes marketed as light or mild. Any false
8 perception of health benefit may exacerbate the tobacco
9 epidemic as it may delay quitting or increase
10 initiation."
11 Q. CKT028290. Could you read the finding on
12 question number two made by the panel that you were a
13 part of?
14 A. "The panel concludes that terms such as light and
15 mild in tobacco marketing in Canada are both false and
16 misleading. Substantial proportions of Canadian smokers
17 are being deceived in that they believe these products
18 deliver less tar and nicotine and are less harmful to
19 smokers' health. Allusions to milder taste as well as
20 actual taste differences, compound this deception.
21 "Tobacco industry documents attest that one
22 consequence of this false representation is reduced
23 propensity to quit smoking. Failure to quit smoking is
24 highly likely to have fatal consequences."
101
2 Q. Now that this has come up, tell us a little bit
3 more about how this panel was formed, how the process
4 worked, how you got involved.
5 A. The Canadian Minister For Health was examining
6 this question and felt that the Canadian public was
7 being deceived, and was planning to ban the terms
8 "light" and "ultralight" in Canada. In order to do
9 that, he wanted to get a scientific foundation as to
10 whether or not the conclusions that he believed to be
11 true were, indeed, shared by the scientific community.
12 We put together this expert panel, and we arrived at
13 those conclusions and answered the specific questions
14 that the Minister had with respect to these cigarettes
15 and specifically with respect to the labelling of these
16 cigarettes as light and mild and how the public would
17 interpret them.
22 Q. And the findings that you have been discussing
23 with the Court are the conclusions that you have just
24 talked about; is that right?
103
1 A. That's correct.
2 Q. May I have 028293? Could you tell us about that
3 finding?
4 A. Yes. "We conclude that a complete prohibition of
5 the use of deceptive descriptors such as light and mild
6 on cigarette packaging and marketing is necessary to
7 ensure that past deception is redressed and ongoing
8 deception is prevented. In addition, in order to
9 prevent future deception, the regulations should also
10 restrict the use of other words, colours or devices that
11 result in an erroneous perception of a difference in
12 health risks and/or tar/nicotine deliveries. To be
13 effective, these regulations should be accompanied by a
14 substantial educational component to correct this
15 dangerous and persistent misperception and by a
16 mechanism to implement further measures if warranted."
6 Q. In addition to being involved in this panel, is
7 this also a document that you reviewed and relied upon
8 for your opinions in this case?
9 A. Yes, it is.
10 MR. ZELCS: I move Exhibit 59 into evidence.
11 MR. LOMBARDI: And, Your Honor, my same --
12 THE COURT: I note your objection. It will be
13 admitted over objection. I'll admit it over objection.
14 Q. Has the World Health Organization also reached
15 similar conclusions?
16 A. Yes, they have.
17 Q. Have you had any involvement in the Scientific
18 Advisory Committee on Tobacco of the World Health
19 Organization?
6 Q. Tell us a little bit about your involvement in
7 the Scientific Advisory Committee on Tobacco for the
8 World Health Organization?
9 A. Yes. I was asked to participate on the committee
10 as an expert during the drafting of this particular
11 position, and I am now a member of that committee.
12 Q. Which was that committee formed?
13 A. The committee was formed, I believe, in 1998 or
14 1989.
15 Q. What was the purpose of the committee?
16 A. To provide advice to the World Health
17 Organization on issues related to regulation of tobacco
18 products.
19 Q. What involvement did that committee have with
20 regard to any light cigarette issues?
21 A. One of the principal issues that it considered
22 was the appropriate regulation of light cigarettes.
23 Q. Did the committee ultimately issue a
24 recommendation?
106
1 A. Yes, it did.
2 Q. And let me show you what has been marked as
3 Plaintiff's Exhibit Number 60. Is that a copy of the
4 recommendations issued by that committee?
5 A. Yes, it is.
6 Q. And we have on the screen, I believe, the
7 conclusions that that committee reached; is that
8 correct?
9 A. No. Those are the conclusions for Monograph 13,
10 which the committee reiterated in support. The
11 conclusions are on the next page. The conclusions of
12 the Scientific Advisory Committee are on the next page.
13 Q. Could we highlight those conclusions, please, or
14 magnify them? Would you go through those conclusions
15 with the Court?
16 A. Yes. There were four conclusions. Tar and
17 nicotine and CO numerical ratings based upon current
18 ISO/FTC methods and presented on cigarette packages and
19 in advertising as single numerical values are misleading
20 and should not be displayed.
21 Number two, all misleading health and exposure
22 claims should be banned.
23 Number three, the ban should apply to packaging,
24 brand names, advertising and other promotional
107
1 activities.
2 Number four, banned terms should include light,
3 ultra-light, mild and low tar, and may be extended to
4 other misleading terms. The ban should include not only
5 misleading terms and claims but also names, trademarks,
6 imagery and other means to conveying the impression that
7 the product provides a health benefit.
21 Q. In addition to serving on the committee and
22 helping come to these conclusions, did you also rely on
23 this support as part of your work?
24 A. Yes.
108
1 MR. ZELCS: I move into evidence Exhibit Number
2 60.
3 MR. LOMBARDI: Same standing objections and as
4 otherwise stated.
5 THE COURT: Overruled. It is admitted.
6 Q. By the way, Dr. Burns, help me out on this, if
7 you will. Is the United States included in the World
8 Health Organization?
9 A. Yes. The United States is a Member of the World
10 Health Organization.
11 Q. Thank you, sir. Have any governments other than
12 Canada come to any conclusions with respect to the word
13 "lights" as a cigarette product descriptor?
14 A. Yes. The European Union has.
22 Q. Let me show you what has been marked as
23 Plaintiff's Exhibit 61. What is that?
24 A. This is the Directive of the European Parliament
109
1 that deals with these issues.
2 Q. What involvement, if any, have you had with this
3 directive and its issuance?
4 A. It was one of the many governmental regulatory
5 efforts that we reviewed as part of the Scientific
6 Advisory Committee on Tobacco for the World Health
7 Organization.
8 Q. Let me see if I understand you. You reviewed
9 this directive as part of your work on the World Health
10 Organization committee; is that correct?
11 A. That's correct.
12 Q. Does the directive make any finding relating to
13 light or low tar cigarettes? Let me ask you to call up
14 215, please.
15 A. Yes, it does.
16 Q. Could you highlight that for me and magnify it?
17 Could you tell me tell the Court about the finding this
18 directive makes?
19 A. The directive makes the following finding: "The
20 use on tobacco product packaging of certain texts, such
21 as low-tar, light, ultra-light, mild, names, pictures
22 and figurative or other signs, may mislead the consumer
23 into the belief that such products are less harmful and
24 give rise to changes in consumption. Smoking behavior
110
1 and addiction, and not only the content of certain
2 substances contained in the product before consumption,
3 also determine the level of inhaled substances. This
4 fact is not reflected in the use of such terms and so
5 may undermine the labelling requirements set in this
6 Directive. In order to ensure the proper functioning of
7 the internal market, and given the development of
8 proposed international rules, the prohibition of such
9 use should be provided for at Community level, giving
10 sufficient time for introduction of this rule."
6 Q. Is this a document that you relied upon in
7 forming your opinions in this case?
8 A. Yes.
9 Q. And based upon the finding that was issued in
10 this directive, was there a regulation that was issued
11 by the European Parliament?
12 A. Yes.
13 Q. Is that regulation found in this document? Could
14 you call up Page 217, please?
15 A. Yes, it is.
16 Q. Could you describe that regulation for the Court?
17 Please magnify that.
14 A. The product descriptors, Article 7, "With effect
15 from 30 September 2003, and without prejudice to Article
16 5(1), texts, names, trademarks and figurative or other
17 signs suggesting that a particular tobacco product is
18 less harmful than others shall not be used on the
19 packaging of tobacco products."
20 Q. Again, this directive is something that you
21 reviewed and relied upon as part of your working in this
22 case, your opinions in this case, correct?
23 A. Yes, I did.
24 MR. ZELCS: I move into evidence Exhibit 61, Your
115
1 Honor.
2 MR. LOMBARDI: Same objection that I have
3 articulated.
4 THE COURT: Your objection is noted, and the
5 exhibit is admitted in evidence.
6 Q. Let me go back. You've earlier given us your
7 opinion that lights are no better for you. Is there
8 really any harm for people to choose to smoke Marlboro
9 Lights or Cambridge Lights cigarettes anyway?
10 A. Yes.
15 Q. Is there really any harm?
16 A. Yes. There is profound harm. The people who
17 smoke, the majority of folks, vast majority, are
18 addicted. They're interested in quitting but are unable
19 to do so. In that setting, we need to provide as much
20 encouragement and support for cessation as possible. To
21 provide smokers an alternative that says you don't have
22 to quit, you can use this other type of cigarette, to
23 intercept them on the way to quitting smoking is a
24 profound harm because they continue to smoke longer than
116
1 they might have otherwise. Some of those people who
2 switched might have quit, might have been successful in
3 quitting, and when they did that, they would have in
4 actuality reduced their disease risks. And those
5 individuals have been profoundly harmed.
17 Q. The opinions that you just gave us regarding the
18 harm, is that something that you know to a reasonable
19 degree of scientific certainty?
20 MR. LOMBARDI: No foundation, Your Honor.
21 THE COURT: Overruled.
22 A. Yes, I do.
23 Q. We're almost done. Bear with me.
24 A. Okay.
117
1 Q. How did you first become involved as an expert
2 witness in tobacco litigation? How did it all start?
3 A. In 1983 or 1984, Jesse Steinfeld, who had been
4 Surgeon General of the United States and was at that
5 time the President of the Medical College of Georgia
6 called and asked me if I would testify in a tobacco
7 trial. He felt strongly that it was important that
8 accurate scientific information be provided to the
9 Court. He and I had worked together on several
10 tobacco-related issues, including Surgeon General's
11 Reports, and he asked if I would participate because of
12 because of his inability to participate himself. Since
13 he was the President of the Medical College of Georgia,
14 he asked that I participate so that the information
15 presented to the Court would be accurate and complete.
16 Q. You also testified earlier that you have done
17 some work with the States Attorneys General on this; is
18 that right?
19 A. Yes, I have. I've been involved in twenty or
20 twenty-five of the State Attorney General cases.
21 Q. And after working with the State Attorneys
22 General, were you also asked to consult with private
23 litigants such as the class members in this case?
24 A. Yes, I was.
118
1 Q. What percentage of your time currently do you
2 spend on tobacco litigation consulting?
3 A. Well, it obviously varies on a week-to-week
4 basis, but on an annual basis, it is about five to ten
5 percent of my time.
13 Q. You testified about a lot of things here this
14 afternoon, this morning I guess it still is, and there
15 was discussion about your use of the term "people".
16 When you used the term "people" in your testimony here,
17 were you referring to the class members in this case
18 here in the State of Illinois?
23 A. I was referring specifically to people who have
24 been examined in various epidemiologic and scientific
119
1 studies and the expectation that the observations made
2 on those individuals would be identical for the
3 population that represents this class of litigants.
4 MR. ZELCS: I have no further questions for you.
5 Thank you very much.
6 THE COURT: You may cross examine the witness.
7 CROSS EXAMINATION
8 BY MR. LOMBARDI:
9 Q. Doctor, have you met a member of this class?
10 A. No, I have not.
11 Q. I'm sorry. My name is George Lombardi. We
12 haven't met, have we, Doctor?
13 A. No, we have not.
14 Q. You've not met a member of this class; is that
15 right?
16 A. No.
17 Q. Have you met Michael Fruth?
18 A. No.
19 Q. Have you met Christine Witt?
20 A. No.
21 Q. Ms. Miles?
22 A. No.
23 Q. Ms. McHatton?
24 A. No.
120
1 Q. Ms. Price?
2 A. No.
3 Q. Have you done a medical examination of any of
4 them?
5 A. No, I have not.
6 Q. Examined their smoking behavior?
7 A. No, I have not.
8 Q. Now, you talked a lot about foreign governments
9 in this case, didn't you, Doctor?
10 A. Yes.
11 Q. And you wanted the Court to know what certain
12 foreign governments are doing about light cigarettes?
13 A. That's correct.
14 Q. You didn't talk a whole lot about what the United
15 States government is doing now, did you, Doctor?
16 A. I believe I did, but I'm not sure what you're
17 referring to.
18 Q. Well, you have been in touch with the FTC about
19 this issue, haven't you?
20 A. I have been in touch with the FTC on many
21 occasions. As I said, Monograph 13 was prepared at the
22 request of the FTC.
23 Q. Correct. And you know that the FTC has
24 considered issues relating to its testing method
121
1 literally for decades, don't you, Doctor?
2 A. Yes, I do.
3 Q. You know they instituted the test in 1966 or
4 1967, thereabouts; is that right?
5 A. That's correct.
6 Q. And they have periodically over time had
7 challenges to that test method and considered possible
8 changes in the test method; isn't that correct?
9 A. Yes, they have.
10 Q. And in the 1980s, in the 1980s, there were
11 specific challenges to the FTC test method in regard to
12 a matter that has been called the Barclay matter.
13 You're familiar with that, aren't you?
14 A. I am.
15 Q. And you're familiar with the fact that the FTC
16 specifically considered the fact that people smoke
17 differently when it considered its method in the context
18 of the Barclay situation; is that right?
19 A. My understanding of the Barclay situation is
20 different than that.
21 Q. Well, you are aware that the FTC was considering
22 a cigarette called Barclay; is that right?
23 A. That's correct.
24 Q. And the way that cigarette was smoked under the
122
1 FTC method; is that right?
2 A. Well, specifically, as I recall, the concern was
3 that the Barclay had channels in the exterior part of
4 the filter, that when they were placed in the machine,
5 the channels remained open, but when someone placed them
6 in their mouth, their lips would compress the channels
7 and close them, and that that concern was the one that
8 was brought to the FTC's attention.
9 Q. And the FTC was well aware of compensatory
10 smoking at that time; is that right?
11 A. They were aware of some evidence of compensatory
12 smoking at that time. Their understanding was not
13 complete.
14 Q. And in fact, the FTC specifically went out to the
15 public and asked for public comment about its method in
16 light of compensatory smoking behaviors; is that right?
17 A. Yes, they did.
18 Q. And that was in April of 1983, Doctor, isn't that
19 right?
20 A. I can't verify the date, but that sounds
21 familiar, yes.
22 Q. And since April of 1983, the FTC has considered
23 further challenges or questions about its methodology
24 for determining tar and nicotine delivery of cigarettes;
123
1 is that right, sir?
2 A. Yes. As I understand it, the FTC has generally
3 accepted that there are enormous problems with its
4 testing method for the last decade or so.
5 Q. Well, let's take it a step at a time, Doctor.
6 You're aware that in 1994 that there was a symposium or
7 a meeting of scientists to consider the FTC method; is
8 that right?
9 A. That's correct.
10 Q. That apparently is one of the few, and I am not
11 being facetious at all, Doctor, that you were not
12 involved in yourself; is that right?
13 A. No. I was present at the meeting, but my father
14 had a stroke halfway through the meeting and, therefore,
15 I left.
16 Q. I didn't mean to bring that up at all, but I'm
17 just pointing out that that was a meeting where others
18 were writing articles and participating; is that right?
19 A. That's correct.
20 Q. And that's what resulted in Monograph 7; is that
21 right?
22 A. That's also correct.
23 Q. And Monograph 7 was specifically put together to
24 specifically consider issues surrounding the FTC method;
124
1 is that right?
2 A. It was put together to convene a group of
3 individuals to present papers on that topic, yes.
4 Q. Okay. And they made recommendations about the
5 FTC method at the end of the conference; is that right?
6 A. They did.
7 Q. And that was published as part of Monograph
8 Number 7 in 1996; is that right?
9 A. Yes, it was.
10 Q. And the FTC decided not to change its method as a
11 result; is that right?
12 A. That's correct. Let me be clear. I'm not sure
13 it was a direct result of that meeting, but it did not
14 change its method.
15 Q. Fair enough, Doctor. And you're aware that
16 within the last couple of years, say 1998 or so, the FTC
17 again considered its test method; is that right?
18 A. My understanding is that one of the reasons why
19 they asked the NCI to address the question of whether
20 these cigarettes reduced disease risk.
21 Q. And to date, the FTC hasn't changed its method;
22 is that right?
23 A. It has not.
24 Q. I'm sorry?
125
1 A. It has not.
2 Q. Thank you. I'm handing you, Doctor what has been
3 marked as 4068. You can see that in the bottom
4 right-hand corner?
5 A. Yes.
6 Q. And for the Record, Your Honor, that is a letter
7 dated October 21, 2002 to a Thomas Pahl -- Am I
8 pronouncing that right, Doctor?
9 A. I believe that's correct.
10 Q. P-A-H-L is how it is spelled, correct?
11 A. That's correct.
12 Q. And then it is signed by you and a few others; is
13 that right?
14 A. It is signed by myself, Neal Benowitz, Michael
15 Thun, Lynn Kozlowski, Gary Giovino, Dorothy Hatsukami,
16 and Jack Henningfield.
17 Q. It is on your letterhead, is that right, the
18 University of California, San Diego?
19 A. That's correct.
20 Q. Did you draft the letter?
21 A. I drafted the first draft of the letter. It was
22 then circulated, modified by the other authors, and that
23 resulted in the final version.
24 Q. And you sent this letter after you had had some
126
1 interaction with the FTC; is that correct?
2 A. Yes. I had received a phone call and been
3 subjected to what they described as a structured
4 interview by some lawyers from the FTC.
5 Q. And in this structured interview, they told you
6 that what you were doing or what they were doing was
7 trying to gather information to make some kind of
8 decision on the FTC method and what should be done with
9 it; is that right?
10 A. No. They told me that they wanted to conduct a
11 structured interview of those who had participated in
12 Monograph 13.
13 Q. Okay. Did you have any knowledge at all of what
14 their overall purpose was?
15 A. I had a general knowledge, obviously, that it
16 related to Monograph 13 and to the tar and nicotine.
17 Had I understood what they were doing at the start, I
18 probably would have declined to participate.
19 Q. You did not want to participate with lawyers
20 contacting you on behalf of the United States
21 government; is that true, Doctor?
22 A. No, that is not true.
23 Q. Well, they were lawyers from the United States
24 government; is that right?
127
1 A. They were.
2 Q. These were not tobacco company lawyers?
3 A. They were not tobacco company lawyers.
4 Q. And they did a structured interview; is that
5 right?
6 A. They did the structured interview.
7 Q. Actually, what you became concerned about, you
8 became concerned that they would take the monograph or
9 take the -- Strike the question.
10 You became concerned that they would take that
11 interview and use that to come to conclusions different
12 from the ones you wanted them to come to; is that right?
13 A. No.
14 Q. Let's blow up the yellow part here. You wrote,
15 "Those of us who have participated in the interviews" --
16 That's the enter FTC interviews; is that right?
17 A. That's correct.
18 Q. -- "and who were authors or reviewers of
19 Monograph 13 are uncomfortable with the format of the
20 questions" -- And you are referring to the structured
21 nature of the interview; is that right, Doctor?
22 A. Specific, no. Specific questions that were used
23 as far as the structure. I'm not uncomfortable with the
24 structure.
128
1 Q. Okay. And you go on, "and are concerned that our
2 personal responses may be used to suggest that we
3 support the validity or utility of the testing of
4 cigarettes using the FTC method of machine testing."
5 That's what you said; is that right?"
6 A. That's correct. We were concerned that the
7 results of that interview would be used to misrepresent
8 the opinions of the scientists who signed the letter.
9 Q. And so you're concerned, aren't you, Doctor?
10 You're concerned that in the United States at least, not
11 in Europe, not in Canada, you're concerned in the United
12 States at least, our government might come to a
13 different conclusion than those governments about light
14 cigarettes. That's your concern, isn't it?
15 A. My concern is that our government come to the
16 correct conclusion. In order to come to the correct
17 conclusion, they have to have an accurate representation
18 of what the scientists actually believed. Therefore, we
19 wrote down in specific detail and signed what we
20 actually believed so that they would have that
21 information as part of the process by which they would
22 make that judgment.
23 Q. Well, you just didn't want a correct decision;
24 you have an idea in your own mind what you think the
129
1 correct decision is, don't you, Doctor?
2 A. I'm not sure what you're saying. I certainly
3 would be willing to provide information to the FTC as I
4 have through Monograph 13 and through this letter as to
5 whether the testing and the use of tar and nicotine
6 values in advertising is something that is a public
7 health interest. I believe it is not.
8 Q. You put up the Canadian conclusions, right? You
9 agree with those?
10 A. I certainly do.
11 Q. That's why you put them up?
12 A. That's correct.
13 Q. That's what you would like them to do in the
14 United States, correct?
15 A. I would like them to do something similar in the
16 United States.
17 Q. And you were afraid after this interview that
18 that they might not do what you wanted in the United
19 States, weren't you, Doctor?
20 A. No. I was afraid after the interview that the
21 opinions of the scientists on this issue would be
22 misrepresented in the deliberations that the FTC was
23 conducting and, therefore, I felt it useful to put those
24 opinions directly on record.
130
1 Q. Okay. All right. And so then you go on. You
2 can take that one off.
3 And you go on, and you have about five paragraphs
4 of points that you wanted to make; is that right?
5 A. That's correct.
6 Q. And those points relate to things like how the
7 machine works and whether it is accurate as to
8 individual smokers, correct?
9 A. Yes.
10 Q. And those conclusions deal with the descriptors
11 light, ultra-light, low tar, things like that as well,
12 right?
13 A. Yes.
14 Q. And you say -- Go to Number 4 on the next page.
15 "The use of machine-measured tar and nicotine yields,
16 and the use of descriptors such as low tar, light and
17 ultralight, as descriptors of smoke exposure or disease
18 risk are misleading to the smoking public and are not
19 based on sound scientific evidence of differences in
20 actual smoke exposure disease risk." You wanted the FTC
21 to be very clear that that's what your view was, right?
22 A. That's correct.
23 Q. The next one, please. And then you said, "The
24 conclusion that the existing mandatory testing for tar
131
1 and nicotine" -- That's referring to the FTC test
2 method; is that right?"
3 A. That's correct.
4 Q. And I believe you referred to that mandatory
5 testing in your direct testimony today; is that correct?
6 A. I don't recall whether I used that word or not.
7 Q. The Record is what it is, Doctor. "It is so
8 flawed that it is more misleading than helpful". And
9 you go on from there, right?
10 A. Yes.
11 Q. It is clear that as of the time you wrote this
12 letter that those were issues that were before the FTC;
13 is that right?
14 A. No, it is not clear. It is, unfortunately, not
15 usually clear with the FTC what issue is specifically
16 before them in terms of making a judgment at any point
17 in time. What was clear from the structured interviews
18 was that some individuals within the FTC were interested
19 in representing to other individuals within the FTC what
20 the opinions of the scientists involved in Monograph 13
21 were. And because of that, we felt it was important for
22 us to make very clear what those opinions actually were
23 rather than run the risk that they might be
24 misrepresented.
132
1 Q. Well, at least from your point of view, you had
2 the concern that the FTC was in the process of
3 considering the issues related to the FTC method and
4 descriptors for light cigarettes. And that's why you
5 wrote this letter was to make sure your thoughts were
6 clear; is that right?
7 A. We had no knowledge as to whether they were
8 specifically considering any issue with relation to
9 changing the method. We were concerned that if that
10 issue came up that our opinions not be misrepresented.
11 Q. And you know that to this day, to this day --
12 You've already told me that to this day, the FTC method
13 has not been changed by the FTC; is that right?
14 A. That's correct.
15 Q. How long has Philip Morris used the term "light"
16 in association with cigarettes?
17 A. I can't tell you the first brand of cigarettes
18 that they used that descriptor for, but it's certainly
19 been since the early 1970s at a minimum.
20 Q. Does 1971 sound about right?
21 A. Could be.
22 Q. So that's what, about -- it's over thirty years
23 now?
24 A. That's correct.
133
1 Q. And the over thirty years that Philip Morris has
2 used the term light, are you familiar with any
3 regulation, order, consent judgment that the FTC has
4 issued to prevent Philip Morris from using the term
5 "light"?
6 A. No.
7 Q. Are you familiar with any FTC order, consent
8 judgment or any other regulatory action to prevent
9 Philip Morris from using the term "lower tar and
10 nicotine"?
11 A. No. It is my understanding that they have not
12 done anything in that area at all. The only thing that
13 they have done is in relation to the publication of tar
14 and nicotine values.
15 Q. Now, Doctor you talked some about your litigation
16 experience on direct. Do you remember that?
17 A. Yes.
18 Q. And litigation is a very important part of your
19 career, is it not?
20 A. I don't believe so, no. It certainly is an
21 activity that I have participated in for many years, but
22 I don't believe it is an important part of my career.
23 Q. Well, since you started -- When did you say you
24 first started testifying in tobacco lawsuits?
134
1 A. I think it was 1984 or so.
2 Q. Since you first started in 1984 or so, isn't it
3 true that you have served in some capacity, as a
4 consultant or as a witness -- in some capacity in
5 litigation in hundreds of cases; isn't that true?
6 A. I never counted them up. I can't tell you. But
7 certainly my guess is it would be more than a hundred,
8 yes.
9 Q. And you have been hired to represent -- Strike
10 the question.
11 You talked about being hired by the State
12 Attorney Generals; do you remember that?
13 A. I do.
14 Q. But you also have been hired to represent
15 individual smokers against the tobacco companies; isn't
16 that correct?
17 A. That's correct.
18 Q. You've also been hired to represent insurance
19 companies against tobacco companies?
20 A. That's also correct.
21 Q. You've also been hired by asbestos companies to
22 testify against the tobacco companies?
23 A. No. I was hired by the Manville Trust, which is
24 not an insurance company or an asbestos company as I
135
1 understand it. It is a trust that administers the
2 benefits for asbestos victims.
3 Q. You've worked on mock trials with plaintiffs'
4 lawyers concerning tobacco issues; is that right?
5 A. I participated in three mock trials over the last
6 twenty years.
7 Q. You go in and testify and give plaintiffs'
8 attorneys practice in dealing with scientific issues; is
9 that right?
10 A. I have no idea what the attorneys do with mock
11 trials. I come in, and I do my best to present the
12 science as I understand it, and then they do whatever it
13 is that they do with a mock trial.
14 Q. You have been in hundreds of lawsuits, involved
15 in hundreds of lawsuits, and you have no idea what a
16 mock trial is for?
17 A. Many aspects of the legal process remain a
18 mystery to me, including many of its detailed pieces,
19 and one of those areas of mystery is a mock trial. I
20 don't understand why lawyers do mock trials, but given
21 the frequency with which it is done, I guess it must be
22 something that you value.
23 Q. Now, Doctor, you also give lectures to lawyers
24 who want to sue the tobacco companies; is that right?
136
1 A. I have on one occasion given a talk as part of
2 preparation of litigation, and on one occasion I gave a
3 talk at a seminar.
4 Q. Do you help recruit plaintiffs' lawyers to sue
5 the tobacco companies?
6 A. I don't believe so.
7 Q. Have you talked to plaintiffs' lawyers who have
8 never sued tobacco companies about suing tobacco
9 companies?
10 A. Certainly. Many of the phone calls that I get
11 from lawyers are from individual lawyers who are
12 thinking about suing tobacco, and I respond to those by
13 talking to those individuals.
14 Q. Now, you were once hired to write a book for the
15 asbestos companies and their insurers to use in a
16 lawsuit against the tobacco companies; is that right?
17 A. I was hired to write, myself and several others,
18 were hired to write a book that defined the evidence on
19 cigarette smoking and cancer, cigarette smoking and lung
20 disease, asbestos and cancer and lung disease, as well
21 as the interaction between asbestos and cigarettes. One
22 of the reasons for laying out that science was to
23 support crossfire of cigarette companies in asbestos
24 litigation.
137
1 Q. You knew that that book was going to be used for
2 litigation purposes; is that right, Doctor?
3 A. I knew that laying out the science was a critical
4 first step to understanding whether those legal
5 proceedings could go forward.
6 Q. Now, it is not just the tobacco companies that
7 you have gone up against in litigation; is that right,
8 Doctor?
9 A. That's correct.
10 Q. You've gone up against asbestos victims as well?
11 A. Yes.
12 Q. And you have served as a physician who examines
13 people who claim they're victims of asbestos and make
14 medical determinations about those people, don't you, or
15 haven't you, Doctor?
16 A. That's correct. In one instance, I examined
17 patients who had asbestos exposure and substantial
18 amounts of asbestos disease, I might add, in Texas.
19 Q. And these were people that were seeking recovery
20 for the physical injuries they had suffered allegedly
21 from asbestos; is that right?
22 A. That's correct.
23 Q. And you were on the side of the asbestos
24 companies at that time; is that right?
138
1 A. In that instance I was, yes.
2 Q. Today, Doctor, as I understand your testimony,
3 because of your commitments in tobacco litigation, you
4 don't have much time to see patients; is that right?
5 A. No. That's not true.
6 Q. Actually, since 1994 --
7 MR. FLACK: Would you let the witness answer? He
8 said that's not true.
9 MR. LOMBARDI: I did not hear that you were going
10 on, Doctor. If you wanted to continue your answer,
11 please continue.
12 A. In the mid 1990s, I made a career shift and began
13 to spend the bulk of my time working on tobacco control
14 research, tobacco control issues. That was done in part
15 because of a philosophical change. That is a
16 recognition that my work in an intensive care unit that
17 was closing the barn door after the horse had left, and
18 that the work on prevention could have a much more
19 profound effect, and it was also a reflection of my
20 professional interests and the available of resources to
21 follow those interests. So it was the opportunity to do
22 research on tobacco issues that lead to the career
23 change not an interest in litigation.
24 Q. Well, as it happened, you ended up becoming more
139
1 involved in litigation, is that right, Doctor?
2 A. Well, the litigation became more common, and I
3 was involved in more cases, yes.
4 Q. So, actually, since 1994 or so, the amount of
5 time you spend with patients has been on the decline,
6 and the amount of time you spend on lawsuits has been on
7 the rise; is that right?
8 A. No, that is not true. The amount of time that I
9 spend on patients has been relatively constant over the
10 last four or five, six years, and it is lower than it
11 was during the first fifteen years of my career.
12 Q. Well, literally, today -- literally, you spend as
13 much time on lawsuits as on patients; is that right?
14 A. I spend about five percent on each, yes.
15 Q. If you took it on a yearly basis, you spend about
16 one month of the year on patients; is that right,
17 Doctor?
18 A. I'm on consult service one month out of the year.
19 That's correct.
20 Q. Now, you work on Surgeon General Reports at the
21 same time that you're retained to work on tobacco
22 litigation; is that right?
23 A. That's right.
24 Q. So you write the Surgeon General Reports, and
140
1 then you go into court and testify about those reports;
2 is that right?
3 A. That's correct.
4 Q. And when you put your, when you write your
5 Surgeon General's Reports these days, you're certainly
6 aware of the fact that you're going to be testifying in
7 court in the future about those reports, aren't you?
8 A. Not specifically, but obviously they form part of
9 the body of evidence that exists. Depending upon the
10 question being asked in the lawsuit, I may be asked to
11 testify.
12 Q. So as you write those reports, you take into
13 account the fact that you are going to have to be
14 testifying about whatever you put in those reports; is
15 that correct?
16 A. In general, I don't think that is much of a
17 consideration. In general, we are looking at issues of
18 trying to be clear and expressing what the science says.
19 And issues of litigation, if they come up at all, they
20 usually don't, are very peripheral.
21 Q. And when you do that, when you do that, is it
22 your testimony as you're writing these Surgeon General
23 Reports that you don't consider in your own mind that in
24 a few months or maybe in a few weeks you're going to be
141
1 in court testifying for a plaintiff on these same
2 issues; is that your testimony?
3 A. I think those are both observations that I have
4 in my mind. I don't believe that in the complex task,
5 with so many scientists, trying to define clearly what
6 the science actually says that the knowledge that I do
7 testify has much impact on the choice of language.
8 Q. Would you agree with me that it would be wrong
9 for you to let your litigation experience influence the
10 way that you write these reports, like the Surgeon
11 General's Reports?
12 A. I think it would be wrong to base those reports
13 on anything other than the body of science that exists.
14 Q. Okay. Now, in all of these Surgeon General
15 Reports and monographs that you have written, do you
16 ever disclose the fact that you are a paid expert for
17 plaintiffs against the tobacco industry?
18 A. Absolutely. I routinely disclose that to the
19 Office on Smoking and Health and to the National Cancer
20 Institute during the entire time I've been involved in
21 litigation.
22 Q. Actually, my question for you, Doctor, was do you
23 disclose it in the reports themselves?
24 A. There is no place for such disclosure in either
142
1 the Surgeon General's Report or in the monographs
2 because of the nature of the review process.
3 Q. And so I take it you don't disclose it; is that
4 right?
5 A. There isn't anyplace to put it so it isn't there,
6 that's correct. It's not disclosed.
7 Q. Now, you were involved, actually, in the Surgeon
8 General's Report for the year 2000. I think you
9 testified to that on direct; is that right?
10 A. Yes.
11 Q. In the Surgeon General's Report for 2000, you
12 were a senior reviewer, I believe?
13 A. That's correct.
14 Q. And in the Surgeon General's Report of 2000, you
15 indicate, along with your fellow authors and reviewers,
16 that litigation should be used as a vehicle of tobacco
17 control; is that correct?
18 A. I do not indicate that. That is included as one
19 of the components of tobacco control discussed in that
20 volume.
21 Q. We'll get that report so we can take a look at
22 it, Doctor, but is it true, Doctor, that you view
23 tobacco lawsuits as way to control the behavior of the
24 tobacco companies?
143
1 A. That is partly true. It is my opinion that given
2 the nature of some of the activities of the tobacco
3 industry that the courts are an effective tool for
4 altering their behavior. But as to whether tobacco
5 litigation as some generic concept alters tobacco
6 industry behavior, I'm not sure I would agree with that.
7 Q. Here is Exhibit 7091. I'll hand it off to the
8 Court. Doctor, I'll tell you this. We got this off the
9 CDC web site. That is the title page as it appeared on
10 the CDC web site. I'm not going to ask you to read
11 every page of the document, but can you identify that at
12 least superficially it looks to be the 2000 issue of the
13 Surgeon General's Report?
14 A. Certainly appears to be.
15 Q. Why don't we go to Page 709.17.
16 A. I'm sorry?
17 Q. I'm sorry. I have a different set of numbers.
18 It is in the introductory section, VI. It is in the
19 list of reviewers. Have you found that?
20 A. Yes.
21 Q. And you see your name there at the bottom of the
22 right hand column?
23 A. Yes. Technically it is two up from the bottom,
24 but yes.
144
1 Q. That's fair. And so you were a reviewer of this
2 one; is that right?
3 A. Yes, I was.
4 Q. There were a lot of lawyers that were actually
5 involved as authors and reviewers in the Surgeon General
6 Report?
7 A. Yes. They had a whole section dealing with
8 history of litigation and its role in tobacco control.
9 It included a number of lawyers both as authors and as
10 reviewers.
11 Q. Let's go to page -- Doctor, in your copy, it will
12 be Page 223, and for my purposes 7091.228. Just let me
13 know when you have found it, Doctor. That is a page
14 that has a section entitled "Litigation Approaches"; is
15 that right?
16 A. That's right.
17 Q. If you go over to the next page, Page 224, up
18 there at the top on the left-hand side.
19 A. Which page?
20 Q. Page 224. It should be the next one from where
21 you were.
22 A. Yes.
23 Q. It says, "Private Law As a Means of Risk
24 Control". Do you see that?
145
1 A. Yes.
2 Q. You go on to talk about in the next column,
3 "Potential Public Health Benefits of Tobacco Litigation.
4 "As applied to lawsuits against the tobacco
5 industry, private industry has the potential to do" --
6 And then you list a bunch of factors that relate to
7 controlling the tobacco company's conduct; is that
8 right?
9 A. No. I don't. The report does.
10 Q. You're a reviewer of the report. I thought I
11 understood this morning that you were taking some credit
12 for all of these reports, Doctor. Did I have that
13 wrong?
14 A. I think I can take credit for the reports that I
15 authored, and I can take a responsibility as a reviewer
16 for the others.
17 Q. Okay. Well, let's just view this as a report for
18 which you had some responsibility as a reviewer. Is
19 that fair?
20 A. That's fair.
21 Q. Okay. Let's go to the next one, Page 231. It
22 might not be your next page, Doctor, but about seven
23 pages down for you. Page 231. And that's 7091.236. Go
24 ahead and blow that up. In the report for which you had
146
1 some responsibility, Doctor, it specifically talks about
2 consumer protection actions, doesn't it?
3 A. It describes what consumer protections are and
4 what ones have been filed in tobacco, yes.
5 Q. And you know that this case is a consumer
6 protection case?
7 A. That's my understanding.
8 Q. And you understand that you're using this
9 litigation -- as a witness in this litigation, you're
10 using this to try to accomplish certain goals that you
11 have concerning tobacco; isn't that right?
12 A. I think that's an overstatement of my role here.
13 My role here is to testify on science. I believe
14 independent of that role that this litigation has the
15 potential to create change that would be a positive one
16 in terms of what people are provided with as accurate
17 information, but those are independent concepts.
18 Q. Just to be clear, Doctor, you're not here just
19 testifying as neutral. You want this litigation to come
20 out a particular way, don't you, Doctor?
21 A. I'm here testifying as an expert and attempting
22 to be as accurate and objective as I can. In addition
23 to that, yes, I believe that if this lawsuit is brought
24 to fruition for the plaintiffs that that will lead to an
147
1 improvement in public health.
2 Q. Okay. So you would like to see plaintiffs win
3 this lawsuit?
4 A. Yes, I would.
5 Q. Now, Doctor, you testified in some detail about
6 Monograph 13, which the Court has seen on numerous
7 occasions already?
8 A. Are we done with this so I can clip it?
9 Q. That would be fine. If you want me to move it
10 out of the way, I would be happy to do that.
11 A. I'll even let you clip it.
12 Q. And I will let somebody else clip it. Monograph
13 13 was published in November of 2001; is that right?
14 A. That's correct.
15 Q. And how long did you say you had been working on
16 Monograph 13 in advance of its publication date?
17 A. Well, specifically on Monograph 13, I believe it
18 was three years or so.
19 Q. So back to about 1998; is that right?
20 A. Somewhere around that point. I can't tell you
21 the exact first date of the study.
22 Q. Now, in that time period, 1998 to November of
23 2001, you were extremely busy with the litigation aspect
24 of your work; is that right?
148
1 A. I don't think that's a fair characterization. I
2 was busier than I am now, but it may have gotten up to
3 about twenty percent of my time, no more than that.
4 Q. I'm sorry. I didn't hear the end of your answer,
5 Doctor.
6 A. It may have got up to about twenty percent of my
7 time or so.
8 Q. Twenty percent of your time was spent on
9 litigation. Was that in 1998?
10 A. I can't tell you specifically for that year.
11 Q. It was --
12 A. It was more than it has been recently but I can't
13 tell you the exact time.
14 Q. 1998, was it more than it has been recently and
15 1999 as well?
16 A. My recall is that those were busy years, but I
17 can't quote them with precision for you, but my recall
18 is that the period of '97, '98 and '99 were busier than
19 they have been subsequent to that.
20 Q. Okay. You mentioned twenty percent. Is twenty
21 percent a number that you're comfortable with for time
22 you were spending on litigation issues in 1998 and 1999,
23 Doctor?
24 A. Twenty percent is a seat of the pants guess.
149
1 Q. Your best guess, though, while you're sitting
2 here, Doctor?
3 A. It is a seat of the pants guess by me at this
4 point in time.
5 Q. While you started work on the monograph in 1998
6 and you were spending the seat of your pants guess
7 twenty percent of your time on lawsuits, those lawsuits
8 frequently involved issues related to low tar
9 cigarettes; is that right?
10 A. As I recall, most of those lawsuits involved
11 other issues, but to the extent the lawsuits involved
12 misrepresentations by the tobacco industry or involved
13 disease consequences, issues of low tar and nicotine
14 cigarettes may have related to both of them.
15 Q. Well, you remember, for instance, you testified
16 in a case called the Washington AG case. Do you
17 remember that?
18 A. Yes.
19 Q. Do you remember you talked about low tar
20 cigarettes in that case?
21 A. As one of the pieces of testimony, I put my
22 opinions on low tar and nicotine cigarettes.
23 Q. I'm not saying that you exclusively testified in
24 that time period on low tar issues, but you were
150
1 testifying regularly about low tar cigarettes as part of
2 your overall testimony in that 1998-1999 time frame is
3 that right?
4 A. Those questions came up in several cases, yes.
5 Q. Okay. And while you were testifying, during that
6 period of time you were testifying in 1998 and 1999,
7 after you would testify, you would go back home or to
8 your office, and you would work on your chapter of this
9 monograph; is that right?
10 A. Yes. During that period of time, I was doing
11 that activity. That's correct.
12 Q. So you would go testify in the Washington AG
13 case, and then you would go home and work on your
14 chapter of Monograph 13; is that right?
15 A. Well, I don't believe it was sequenced exactly
16 that way, but both were activities that I was conducting
17 at the same time, yes.
18 Q. Let me ask you this, Doctor: Did you have a goal
19 as part of your work as a tobacco control person that
20 the Monograph 13 should deny that marketing of light
21 cigarettes is a legitimate activity? Was that your
22 goal?
23 A. I don't quite understand your question. The goal
24 of Monograph 13 was to lay out the science as to whether
151
1 cigarette smoking of light cigarettes was any more or
2 less risky than cigarettes with higher tar and nicotine
3 values. The interest was to define that specifically,
4 and then once we had defined that to offer some limited
5 observations about whether or not the information the
6 public currently had on those issues was indeed
7 consistent with the body of science that we had just
8 defined or whether they were misunderstanding and being
9 mislead on those issues.
10 Q. Well, here is my question, Doctor. At the time
11 you started working on Monograph 13 and the chapters you
12 worked on in that monograph, was your goal in preparing
13 those chapters to deny, to come up with evidence that
14 would help to deny that marketing light cigarettes was a
15 legitimate activity?
16 A. My goal was to define whether light cigarettes
17 were less risky or not. That was the goal, and we
18 accomplished that goal. Once you accomplish that goal,
19 then yes, it was important to examine the question of
20 what people understood from low tar, light, and other
21 terms that had been used to characterize the cigarettes
22 we were examining for their risks. So we did both of
23 those, but the goal was to provide the scientific
24 understanding of what the risk was and then to describe
152
1 what people understood about those risks.
2 Q. Well, do you agree with this, Doctor: That if
3 there is, if there is a decrease in the disease burden
4 associated with smoking low tar cigarettes, then the
5 marketing of low tar cigarettes is a legitimate
6 activity. Do you agree with that?
7 A. I think that that is far too broad for me to
8 agree to. I think, one, the premise is factually
9 incorrect, and, therefore, it is difficult for me to get
10 to the second part. And the second part says anything
11 that you want to do is okay, and I don't believe that
12 that is correct.
13 Q. Have you ever said yourself, Doctor, that if
14 there was a decrease in the disease burden then the
15 marketing of low tar cigarettes is a legitimate
16 activity?
153
1 Q. My question to you, Doctor, is have you ever said
2 if there is a decrease in the disease burden, then the
3 marketing of low tar cigarettes is a legitimate
4 activity?
5 A. I can't tell you that I have used exactly those
6 words. I probably have. That is certainly what we said
7 in 1981 in the Surgeon General's Report. We said that
8 smokers who cannot quit are well advised to switch. If
9 you are marketing those products to individuals who are
10 not interested in quitting and cannot quit and there is
11 a substantive reduction in disease risk that occurs with
12 their use, then that is a legitimate activity.
13 Q. Doctor, you had communications with Dr. Michael
14 Thun as part of your work on the monograph; is that
15 right?
16 A. Yes. That's correct.
17 Q. And in the course of those communications, you
18 talked about whether the marketing of low tar
19 cigarettes, light cigarettes, is a legitimate activity,
20 didn't you?
21 A. Yes, we did.
22 Q. And you specifically said to him that if one
23 accepts that there is a likely reduction in the disease
24 burden, then marketing of light cigarettes is a
154
1 legitimate activity despite the risk it may interfere
2 with cessation. Didn't you say that?
3 A. I said that. However, that is in the context of
4 marketing to people who are going to continue to smoke
5 and who are not interested in quitting.
6 Q. Let me show you Exhibit 4330, Doctor. And
7 Doctor, you can see from that that this is an entire
8 group of e-mails. Can you see that?
9 A. Yes.
10 Q. And Doctor, actually, not one of these e-mails
11 came from your computer, did they?
12 A. No.
13 Q. That's because you deleted all of your e-mails
14 related to the monograph; is that right?
15 A. I delete all of my e-mails after a certain period
16 of time.
17 Q. Did you also destroy all of your drafts of
18 Monograph 13, Chapter 4?
19 A. No. I did not destroy them. I had provided
20 e-mails and all of the drafts and all of the draft
21 comments and all of the reviewers' comments to the
22 National Cancer Institute with the express understanding
23 that they told me at the time that they would be made
24 available to anybody that wanted them. Having done
155
1 that, I felt no obligation to then keep second copies
2 littering up my office, and so, I got rid of them. I
3 threw them all away.
4 Q. Thank you, Doctor. You see Bates numbers at the
5 bottom of the page, HHA6740071, which is the third page
6 in. Do you have that? It says at the top, "Michael"?
7 A. Yes.
8 Q. You recognize that as something that you wrote;
9 is that correct?
10 A. That's correct.
11 Q. And then in that first paragraph, Comment A, it
12 says up there -- Comment A is one of Dr. Thun's
13 comments, and you're now responding to it, right?
14 A. That's correct.
15 Q. You say to him in the highlighted portion, "I
16 agree that one of the core policy issues is the use of
17 the term light as an unproven health claim, but to make
18 that policy point, it is necessary to make a conclusion
19 as to whether the evidence supports or does not support
20 a reduction in the disease burden with the use of light
21 cigarettes." That conclusion the purpose of the risk
22 chapter. That's what you wrote to Dr. Thun, correct?
23 A. That's correct.
24 Q. And your concern was we can't just come out
156
1 there, Dr. Thun, and say lights is an unproven health
2 claim unless we establish that there is no decrease in
3 the risk with light cigarettes. That's what you were
4 saying, is that right, Doctor?
5 A. No. What I was saying was that we needed to
6 answer the question that we were asked, which is whether
7 there was a reduction in risk from the use of these
8 types of cigarettes, and that we couldn't not answer
9 that question by introducing a variety of other concerns
10 such as initiation effects, cessation effects as some
11 general policy effect, that we had to actually answer
12 the question that was posed to us for the monograph.
13 Q. But unless you concluded that there was no likely
14 decrease in the disease burden associated with the use
15 of light cigarettes, you could not conclude that lights
16 was an unproven health claim and an illegitimate
17 activity; isn't that right?
18 A. The first step in the process is to examine
19 whether or not the cigarettes are indeed less hazardous
20 or not. That is indeed the first step of the process,
21 yes.
22 Q. But what you're talking about here in the first
23 sentence we just looked at is the core policy issue of
24 whether they can use the term light, right?
157
1 A. The core policy issue is whether the term light
2 as it is generally understood by the public as meaning
3 delivering less of had a relation to the actual
4 scientific facts of what people were getting, less of in
5 terms of tar and less of in terms of risk. We had to
6 answer those two questions directly in the volume in
7 order to make the review of this evidence meaningful to
8 the folks who were going to have to form policy
9 decisions related to the use of the science.
10 Q. You're involved in those policy decisions.
11 You're in tobacco control, aren't you, Doctor?
12 A. I'm involved in providing evidence that supports
13 the policy decisions. The policy decisions are made by
14 the individuals who have the authority to make those.
15 Q. And you help with those policies by going out and
16 testifying for plaintiffs in lawsuits against the
17 tobacco industry, correct?
18 A. It is not my understanding that courts make
19 policies. It is my understanding that regulatory
20 agencies make policies. I certainly have attempted to
21 provide both information and scientific information to
22 regulatory bodies in regard to issues related to the
23 defendant.
24 Q. Let's look at the next thing you said, the next
158
1 part of it. You said to Dr. Thun, "If one accepts that
2 there is likely reduction in disease burden," -- That
3 means if the risks associated with smoking low tar
4 cigarettes are going down, right?
5 A. That there is a lower risk if you use low tar
6 cigarettes.
7 Q. Thank you. I was not as precise. Thank you for
8 the correction. "If one accepts that there is a likely
9 reduction in disease burden, then marketing of light
10 cigarettes is a legitimate activity."
11 A. That's correct.
12 Q. Did you believe that at the time you wrote it?
13 A. I believe that in the context it is written, yes.
14 Q. You believe that today?
15 A. I believe that today, yes.
16 Q. Now, you talked a lot about cessation and
17 interfering with cessation. Do you remember that in
18 your direct testimony?
19 A. That's correct. And that is the important
20 context in which that statement was written.
21 Q. What you say is -- I'm sorry. Go ahead.
22 A. This statement was written because there was a
23 discussion ongoing as to whether or not we could
24 conclude something generally for public health that
159
1 included cessation, initiation effect and all other
2 changes that might have occurred surrounding the use of
3 low tar and nicotine cigarettes or whether we really had
4 to offer an observation that was specific, the low tar
5 and nicotine cigarettes. What I was trying to point out
6 to Dr. Thun and what we were discussing actively for an
7 extensive period of time was that, A, we had to answer
8 the question because that's the one we were asked, and
9 that, B, if indeed there is a real reduction in harm,
10 then it is a legitimate activity to market those
11 products to people who will not quit. That is not a
12 statement that all marketing of light and ultralight and
13 low tar cigarettes is a legitimate activity, only if
14 there are some legitimate marketing approaches if there
15 is a real risk reduction.
16 Q. Are you finished?
17 A. Yes.
18 Q. Now, were you concerned at the time that you
19 wrote this note that if the monograph did not conclude
20 that there was no likely reduction in disease burden
21 that then the monograph would be taken as indicating
22 that marketing light cigarettes is a legitimate
23 activity?
24 A. No. I was concerned that if we didn't answer the
160
1 question that the FTC and the NCI and the FDA had asked
2 us to answer that we would not have fulfilled our
3 responsibilities in this process.
4 Q. Okay. Now, you said what you said about marketing
5 light cigarettes and whether or not it is a legitimate
6 activity. Then you go on to talk about cessation, and
7 you talked this morning about one of the big problems
8 with light cigarettes is that it interferes with
9 cessation. That's what you said this morning; is that
10 right?
11 A. I said this morning it was one of the concerns,
12 if it interferes with cessation.
13 Q. That is one of your big concerns. It was one of
14 your big concerns at the time you wrote this to
15 Dr. Thun; is that right?
16 A. That's right.
17 Q. You say that if there is a likely reduction in
18 the disease burden, then marketing of light cigarettes
19 is a legitimate activity despite the risk that it may
20 interfere with cessation; is that right?
21 A. That's correct.
22 Q. And that was correct. That was accurate at the
23 time you said it?
24 A. It was accurate at the time I said it.
161
1 Q. It is accurate today?
2 A. It is accurate today in the context in which it
3 is written, yes.
4 Q. Then you go on to say -- This is something you
5 didn't say this morning, Doctor. You said, "This is
6 particularly true given the absence, the absence of
7 current evidence establishing that switching to light
8 cigarettes reduces the likelihood of cessation." That's
9 what you said then; is that right?
10 A. That's what we said then. That is what it says
11 in the report. The evidence that exists suggests that
12 there is an interference with cessation, but it does not
13 reach the level of establishing that that is a fact. So
14 there is a concern. The evidence that does exist
15 supports that concern, but the evidence is not
16 sufficient to reach scientific certainty.
17 Q. Just to be precise, Doctor you didn't actually
18 put it quite that way. You said, "Given the absence of
19 current evidence establishing that switching to light
20 cigarettes reduces the likelihood of cessation." That's
21 what you said then?
22 A. That's what I said.
23 Q. Were you being honest with Dr. Thun when you said
24 that?
162
1 A. Absolutely. And the operative word there is
2 "establishing". That certainly was understood by
3 Dr. Thun. He had read the sections that describe the
4 evidence in the monograph. He was aware of the evidence
5 in the monograph. What we were discussing was not that
6 there isn't any evidence. What we were discussing was
7 that the evidence doesn't reach the level of scientific
8 certainty.
9 Q. Correct. That's what you're here to testify
10 about, right, Doctor?
11 A. That's correct.
12 Q. It is true today that there is an absence of
13 current evidence establishing that switching to light
14 cigarettes reduces the likelihood of cessation. That's
15 true today, isn't it, Doctor?
16 A. We have gained further understanding. There is a
17 body of evidence that continues to grow on that. I
18 don't believe it yet has reached the level where we have
19 tracked folks who have used the light cigarettes and
20 looked at their subsequent cessation pattern, so it
21 hasn't reached the level of establishing that as a
22 scientific factor.
23 Q. So anything you said this morning about delays in
24 cessation caused by light cigarettes is something the
163
1 Judge should know has not been established to a
2 scientific certainty; is that right?
3 A. The Judge should know that this is a major public
4 health concern, that the evidence that does exist
5 suggests that it has been a real concern but that it has
6 not been established beyond a scientific doubt at this
7 moment in time.
8 Q. Thank you, Doctor. Now, let's read the last
9 sentence in this paragraph "This chapter is on health
10 effects, and we need to draw a conclusion on whether or
11 not the evidence supports a reduction in disease burden
12 due to the changes in cigarette design." Did I read
13 that right?
14 A. That's correct. That is the charge that we were
15 given.
16 Q. Dr. Thun, you're kind of chastising Dr. Thun here
17 because he didn't want to come to a conclusion about the
18 health effects and whether the evidence supports a
19 reduction in disease burden, and you're telling him we
20 have to do it, Michael. We have to do that.
21 A. Dr. Thun is a quite distinguished and
22 accomplished physician. I doubt that it is appropriate
23 to term a discussion between the two of us as
24 chastising. What I am saying is I'm articulating a
164
1 point that says this is the question that we are asked
2 to answer. We need to answer it.
3 Q. Well, let me take the word "chastise" out because
4 I didn't mean to imply anything by that. But, Doctor,
5 what you're doing here is you're reminding Dr. Thun we
6 have to answer that question. He's saying we shouldn't
7 answer it. You're saying but we have to. Is that
8 right, Dr. Burns?
9 A. Dr. Thun is not saying that we shouldn't answer
10 that question. He has proposed various language. We
11 were in the process of struggling through the picking
12 the right language for the conclusions that would be the
13 most scientifically valid and accurate, and we are
14 discussing the implications of various choices of
15 language in the conclusions. And what I am saying to
16 him in this statement is that we need to make a specific
17 conclusion that deals with the disease risks, and that
18 treating it simply as a global public policy or public
19 health issue wouldn't be sufficient to answer the
20 question we had been asked to answer.
21 Q. Now, Doctor, what was your official title with
22 Monograph Number 13?
23 A. I'm not sure what you're asking.
24 Q. Contributing, senior editor, I can't remember
165
1 what your actual title was.
2 A. I was one of two editors for the volume.
3 Q. You said when somebody writes a chapter for a
4 Surgeon General Report, they submit that chapter, and
5 then they lose control of it; is that right?
6 A. That's correct.
7 Q. And the editor of the Surgeon General Report then
8 has control of it and works with lots of other people to
9 be sure, but the point is that the original author no
10 longer has the ability to change or alter that chapter;
11 is that right?
12 A. That is true for the Surgeon General's reports,
13 and I made it clear that in the monographs, we had a
14 different process.
15 Q. The monograph, this monograph in particular, you
16 were both the editor of your chapter and the author of
17 your chapter?
18 A. That's correct.
19 Q. You had a different stake in your chapter than
20 what a normal editor would -- Well, let me take the word
21 "normal" out because I'm sure that will bother you. You
22 had a different stake in your chapter than say an editor
23 of a Surgeon General Report would have in a chapter that
24 he was editing; is that right?
166
1 A. Not based upon my experience. My experience is
2 that the stake is identical. Both of us would be
3 profoundly interested in making sure that the science
4 expressed is clear and accurate and reflects the
5 consensus of scientific thought.
6 Q. Would you agree at least as both the editor and
7 the author of this chapter that you had a bigger role
8 than the author of a section of a Surgeon General's
9 Report would have?
10 A. I had both roles, yes.
11 Q. And you were continually involved in the
12 discussions about the substance of your chapter of the
13 monograph; is that right?
14 A. Absolutely.
15 Q. You talked to virtually every reviewer who was
16 involved in this chapter; is that right?
17 A. I certainly did, and I also discussed it on
18 multiple occasions with people at the NCI and at various
19 other venues where the individual is concerned about the
20 monograph.
21 Q. Did you have a policy as editor of Monograph 13
22 to have at least one author of every chapter be somebody
23 who has testified against the tobacco companies?
24 A. No. I did not.
167
1 Q. Is that the way it worked out, Doctor?
2 A. It might have. I don't know.
3 Q. Well, we can look at it if you're unclear. Let's
4 go to 7109. This is Monograph 13. Do you have the
5 monograph up there still, Doctor?
6 A. No.
7 Q. Where did your copy go? I can get you a copy if
8 you need it, but I thought you had a copy up here.
9 A. I don't have a copy up here.
10 Q. If you could refer to the acknowledgements, that
11 is Page III. There is Chapter 1. That is you and
12 Dr. Benowitz, correct?
13 A. That's correct.
14 Q. You two are long-time participants for plaintiffs
15 in tobacco litigation; is that right?
16 A. Both of us have testified. I don't know how
17 extensively Dr. Benowitz has testified.
18 Q. Next page, please. Chapter 2 on cigarette
19 design, that's Dr. Kozlowski. You know that he has
20 testified against tobacco companies; is that right?
21 A. In litigation? I did not know that.
22 Q. And then Chapters 3 and 4, there is you and
23 Benowitz again. We talked about that. Then go to is
24 Chapter 5. Has Deitrich Hoffman testified against the
168
1 tobacco industry?
2 A. I don't know. It is my understanding that
3 Dr. Hoffman did not testify, but I may be wrong.
4 Q. I'm just asking for your knowledge, Doctor. How
5 about Dr. Weinstein?
6 A. I don't know whether Dr. Weinstein has testified
7 or not.
8 Q. You know about Dr. Pollay; is that right?
9 A. I know Dr. Pollay has testified.
10 Q. Extensively; is that right?
11 A. I don't know the extent to which he has
12 testified.
13 Q. At least you two frequently overlap at trials; is
14 that right?
15 A. I have seen him at two trials, I believe.
16 Q. Now, at the time that you were working on the
17 monograph -- Let me ask you this: When did you first
18 send out a chapter for comment?
19 A. I can't tell you the precise date. It was
20 probably sometime in 1998 or 1999.
6 CROSS EXAMINATION (Cont'd.)
7 Questions By Mr. Lombardi:
8 Q. Doctor, I don't think I asked
9 you. We asked about the number of lawsuits
10 you've been involved in in some capacity.
11 You've actually testified at trial thirty some
12 odd times. Is that correct?
13 A. That's approximately correct.
14 Yes.
15 Q. Okay. And you told us about the
16 percentage of time you've spent on tobacco
17 issues generally, and we talked about a variety
18 of years between '98 and the present. Do you
19 remember that?
20 A. Yes.
21 Q. In the year 2000, was your income
22 from those appearances in court somewhere
23 between fifty thousand and two hundred thousand
24 dollars?
2
1 A. Probably that.
2 Q. And you can't be more specific
3 than that as, I understand it. Is that right?
4 A. It's been a long time since I did
5 those taxes, and I honestly don't know. I never
6 broke it out that way.
7 Q. Okay. And that would be about
8 the -- you'd have about the same answer for the
9 year '99 as well. Is that right?
10 A. I don't know about '99.
11 Q. And you can't remember '98
12 either. Is that right?
13 A. That's correct.
14 Q. And you're paid at the rate of
15 five hundred dollars an hour in this case. Is
16 that right?
17 A. That's correct.
18 Q. Okay. Now, as it happens while
19 you were working on the Monograph and talking to
20 interviewers and your co-authors, you were also
21 testifying in a number of tobacco cases. Is
22 that right?
23 A. That's correct.
24 Q. And you testified -- let's just
3
1 start with December of 2000. You testified in a
2 trial called Falice in Brooklyn. Is that right?
3 A. That's correct.
4 Q. And in January of 2001, you
5 testified in the Little trial. Is that right?
6 A. That's correct.
7 Q. And what state was that one in?
8 A. That was in South Carolina.
9 Q. And you testified in a Blue Cross
10 Blue Shield case against the tobacco companies
11 in March of 2001. Is that right?
12 A. That's correct.
13 Q. Back in Brooklyn. Right?
14 A. (Nods head).
15 Q. That was in Brooklyn. Right?
16 A. Yes.
17 Q. Okay. And then the Mehlman case
18 in April of 2001 was in New Jersey. Is that
19 right?
20 A. That's correct.
21 Q. And then back to Brooklyn for more
22 on this Blue Cross-Blue Shield case in May?
23 A. Yes.
24 Q. And then to West Virginia for the
4
1 Blankenship case in September. Is that right?
2 A. That's correct.
3 Q. And then there was the Burton
4 trial in February of 2002. Is that right?
5 A. That's correct.
6 Q. And you had a trial in Oregon in
7 February of 2002. Is that right?
8 A. That's correct.
9 Q. And last summer you were in Los
10 Angeles for a trial. Is that right?
11 A. That's correct.
12 Q. And last week you were in New
13 Orleans for a trial. Is that right?
14 A. That's also correct.
15 Q. Okay. Now, when you were working
16 on the Monograph, one of the people who had
17 comments for you is someone named Richard Peto.
18 Is that right?
19 A. Yes.
20 Q. Richard Peto is a famous person in
21 the world of epidemiology. Is that right?
22 A. He's a distinguished
23 epidemiologist.
24 Q. He's from Britian?
5
1 A. That's correct.
2 Q. And he's very well known to you
3 and to everybody who worked on the Monograph.
4 Is that right?
5 A. That's correct.
6 Q. And he's the kind of guy who, even
7 if you don't agree with him, you listen to what
8 he has to say. Is that right?
9 A. I like to think we listen to most
10 of what everybody has to say, but he's certainly
11 a distinguished authority. Yes.
12 Q. All right. And Doctor Peto
13 reviewed your chapter and wrote you some
14 comments on it. Is that right?
15 A. Technically the answer to your
16 question is no. However, he certainly had many
17 comments on the topic that were both directly
18 communicated to me and communicated to others.
19 Q. Okay.
20 A. I mean, to be clear, when we sent
21 him the chapter for review, he sent back a
22 letter that said since we hadn't adopted his
23 position, he wasn't going to review it. But
24 both prior to that and subsequent to that, he
6
1 did provide us information and insights that we
2 used in preparing the Monograph.
3 MR. LOMBARDI: One moment,
4 Your Honor.
5 THE COURT: Sure.
6 Q. (By Mr. Lombardi) Okay, Doctor
7 Burns. I'm going to hand you an exhibit. It's
8 been marked as 4440. This is --
9 MR. LOMBARDI: For purposes
10 of identification, Your Honor.
11 Q. (By Mr. Lombardi) This is a letter
12 from Richard Peto to yourself dated August 14th,
13 2000. Is that right?
14 A. That's correct.
15 Q. And this is a letter that you
16 received from Doctor Peto?
17 A. It is.
18 Q. And it shows Neal Benowitz, among
19 others, as receiving a copy of the letter. Is
20 that right?
21 A. That's correct.
22 Q. And Doctor Peto writes you about
23 the chapter. Is that right?
24 A. No.
7
1 Q. He writes you about the
2 epidemiology related to low tar cigarettes. Is
3 that right?
4 A. That's correct.
5 Q. Okay. And you were working on the
6 chapter in August of 2000. Is that right?
7 A. Yes. Specifically, I had met with
8 Richard in Chicago at the World Congress, and we
9 had an extensive discussion on these issues.
10 And this was a follow up letter to that
11 discussion.
12 Q. Okay. And Doctor Peto, just to
13 get to the bottom line here, Doctor Burns, at
14 this time, Doctor Peto is essentially
15 communicating to you his belief that smoking
16 prevalence, the decline in smoking prevalence
17 doesn't explain the decline in lung cancer rates
18 completely. Is that right?
19 A. No. I think that's too broad a
20 statement. Specifically what Richard was
21 communicating was that in males but not in
22 females, the fall in lung cancer death rates at
23 younger ages, that is under the age of
24 forty-five, exceded the fall in smoking
8
1 prevalence in the United Kingdom.
2 Q. Okay.
3 A. And that was the specific
4 observation that he had made, and he attributed
5 that to a change in the type of cigarette smoke.
6 Q. In other words, he attributed it
7 to the lowering of tar yields in cigarettes. Is
8 that right?
9 A. That's correct.
10 Q. And you made a distinction between
11 the data for males and females in your answer.
12 Do you remember that?
13 A. That's correct.
14 Q. And the fact is that
15 epidemiological data for females has lagged the
16 data for males. Is that right?
17 A. I don't know what you mean by
18 lagged.
19 Q. It's been behind the data for
20 males because women started smoking later.
21 Isn't that right, Doctor?
22 A. The level of risk has been
23 behind. Yes. Because women started smoking
24 later in the century. Sure.
9
1 Q. And Doctor Peto talks in this
2 letter about the British studies that you just
3 referred to. That's one of the things he talked
4 about. Is that right?
5 A. I'm not sure which. He refers to
6 the British data on lung cancer death rates and
7 British survey data on smoking prevalence.
8 Q. Thank you for the clarification.
9 And then he goes on to say that he thinks that
10 may be applicable to United States data as well?
11 A. That's correct. That's one of the
12 things we discussed at the meeting.
13 MR. LOMBARDI: To the next
14 page please, that first part.
15 Q. (By Mr. Lombardi) And he puts some
16 data in there, Doctor Burns, which we won't try
17 to plow through all that today. But we'll talk
18 about what he summarizes there. He's talking
19 about -- he's done some computations about
20 United States data. That's what he's doing at
21 the top of the page. Isn't that right?
22 A. Well, he's generated a table,
23 yes. It's not a computation.
24 Q. He's generated a table concerning
10
1 data from the United States. Is that right?
2 A. Yes.
3 Q. And then he says, "This fits well
4 with my general conclusions for the UK data (see
5 enclosed copy of my letter to Neal Benowitz)
6 that for men in early middle age, the decrease
7 in lung cancer mortality is substantially larger
8 than can plausibly be explained by changes in
9 the prevalence of smoking among adults." That's
10 what he was saying. Is that right?
11 A. That is correct.
12 Q. And that means that he is
13 attributing the decline in lung cancer
14 mortality, at least possibly, to changes in the
15 cigarettes, the design of the cigarettes. Is
16 that right?
17 A. Well, that is what he concluded.
18 That is not what this statement says. What the
19 statement says is that you can't explain the
20 change in lung cancer death rates in the UK by
21 the prevalence of smoking alone as a single
22 measurement. And there is no question that that
23 observation is correct.
24 Q. Okay. And he's saying when he
11
1 says, "This fits well with my general
2 conclusions for the UK data," he's saying that
3 the data that he just put in a table for the
4 United States fits well with his general
5 conclusions for the United Kingdom. Is that
6 right?
7 A. That's what he was suggesting.
8 Yes.
9 Q. And then at the end of the --
10 MR. LOMBARDI: Go to the
11 next one, Janelle, please.
12 Q. (By Mr. Lombardi) Then he says
13 that, "Since 1986, the UK and US trends among
14 men in early middle age have been very
15 favorable." Do you see that?
16 A. Yes.
17 Q. And you know by that, that he is
18 referring to the decrease in lung cancer rates
19 for men in early middle age in both the United
20 Kingdom and the United States. Is that right?
21 A. That's correct.
22 Q. And he says to you, "Don't let
23 mathematical models obscure this."
24 A. That's correct.
12
1 Q. Now, attached we saw down in the
2 cc's you can see --
3 MR. LOMBARDI: If you'd do
4 the enclosure. I'm looking for the top of that
5 where it says letter of 17 July.
6 Q. (By Mr. Lombardi) It says there is
7 a letter of 17 July to Neal Benowitz that was
8 included. Is that right?
9 A. That's correct.
10 Q. And you did get that letter as
11 well. Right?
12 A. I did, and I had previously
13 received it from Neal.
14 Q. Okay.
15 MR. LOMBARDI: For the
16 record, I've handed the witness the exhibit
17 marked as 4441.
18 Q. (By Mr. Lombardi) And, Doctor
19 Burns, is this the letter from Doctor Peto to
20 Neal Benowitz dated July 17, 2000, that was
21 enclosed in the letter to you from Doctor Peto?
22 A. Yes, it appears to be.
23 Q. Okay. And he also -- he addressed
24 similar issues in the letter that he sent to
13
1 Neal Benowitz. Is that right? Similar issues
2 to the ones he addressed in the letter we just
3 looked at to you?
4 A. This letter addressed the UK data
5 only. But other than that, it is similar in
6 content. Yes.
7 Q. Okay. Let's turn to the second
8 page of that letter, 4441.2, and let's go to the
9 last highlighted deal there. And this sums up
10 what Doctor Peto was saying. Is that right?
11 That last highlighed line?
12 A. I'm sorry. Where?
13 Q. I'll read it to you. It's the
14 last line.
15 A. The very last line?
16 Q. Yes. It says -- I'm sorry. I'll
17 read it to you, Doctor. It says, "Tar level
18 reduction should not be opposed." And you
19 understand that's the referred to reductions in
20 tar levels according to machine measure. Is
21 that right?
22 A. Well, I believe Richard is
23 referring to reductions in tar levels that are
24 real, that is ones that apply to people. But he
14
1 is also stating that that may be related to the
2 levels that are made by machine.
3 Q. Okay. And he's saying but they're
4 not a substitute for cessation. Is that right?
5 A. That's correct.
6 Q. And that's obviously something you
7 completely agree with. Is that right?
8 A. That's correct.
9 Q. Okay. And then Doctor Peto sent a
10 letter that you were copied on to Doctor
11 Shopland. Correct?
12 A. To Donald Shopland. He's not a
13 doctor.
14 Q. I'm sorry?
15 A. To Donald Shopland. He's not a
16 doctor.
17 Q. Okay. You'll see that I think
18 then that Doctor Peto made a mistake on the
19 letter then. But Donald Shopland is somebody
20 employed by the National Cancer Institute. Is
21 that right?
22 A. That's correct.
23 Q. And he worked on the Monograph.
24 He worked on Monograph 13?
15
1 A. That's correct.
2 Q. He kind of helped bring it all
3 together, although he didn't do the substantive
4 work on it. Is that right?
5 A. He didn't do the scientific work.
6 He certainly did much of the substantive work.
7 Q. Okay. And Doctor Peto wrote a
8 letter to Donald Shopland in December of 2000
9 expressing concern about your chapter of the
10 Monograph. Is that right?
11 A. Yes.
12 MR. LOMBARDI: For the
13 record, I have handed the witness what's been
14 marked exhibit 4439.
15 Q. (By Mr. Lombardi) And, Doctor,
16 that's a letter. It's at least addressed to
17 Doctor Donald Shopland. Do you see that?
18 A. That's correct.
19 Q. Dated December 22nd, 2000, from
20 Richard Peto showing yourself as a copy on
21 that. Is that right?
22 A. Yes. This is the letter in which
23 Richard Peto declines the opportunity to either
24 review the chapter that has been modified based
16
1 upon the extensive discussion we had in Chicago
2 as well as this letter.
3 Q. Okay. And the first part, the
4 highlighted part there, Doctor Peto says to
5 Donald Shopland, "As you may well already know,
6 I presume that's why you sent it to me for
7 comment. I don't agree with the main conclusion
8 that twenty 1990 cigarettes a day are at least
9 as bad as twenty 1950 cigarettes a day in terms
10 of lung cancer risk. In my view, the national
11 lung cancer trends among young men in the U.S.,
12 and still more so the UK, are more favorable
13 than can plausibly be explained by decreases in
14 cigarette consumption." That's what he says
15 there. Is that right?
7 Q. (By Mr. Lombardi) Okay. Let's go
8 to the next one.
9 A. Well, before you leave that, I
10 should respond I think.
12 Q. (By Mr. Lombardi) And that, Based
13 on your conversations with Doctor Peto, was a
14 concern that he had about your chapter of the
15 Monograph. Is that right?
16 A. I don't think that that fairly
17 reflects that. No.
18 Q. Well, at least this is what Doctor
19 Peto wrote in a letter that you received in
20 about -- around Christmas time of 2000. Is that
21 right?
22 A. It is what he wrote. It misstates
23 the conclusion in the Monograph. It misstates
24 the conclusion in the chapter at the time he
19
1 reviewed it.
2 Q. We're getting there, Doctor.
3 We're going to get there. Let's read the next
4 section.
5 If, however, the next five to ten
6 years of U.S. lung cancer trends in young men
7 continue to be favorable, then your office may
8 well look foolish for having stated as strongly
9 as this report now does that, directly contrary
10 to IARC or IARC conclusions in the mid 1980's,
11 law tar cigarettes are at least as bad as high
12 tar cigarettes."
13 Is that what Doctor Peto was saying to
14 Mr. Shopland?
15 A. That's what he wrote.
16 Q. Okay. And you understood that
17 Doctor Peto was very concerned at this point
18 about the conclusions that you wanted to express
19 in your chapter of the Monograph?
20 A. I understand that. Yes.
21 Q. And that caused concern at the
22 National Cancer Institute; didn't it, Doctor?
23 A. It caused concern for all of us.
24 All of us considered the issues which it was
20
1 raising.
2 Q. And then as a result --
3 A. And we discussed and debated those
4 issues.
5 Q. I apologize.
6 A. Modified the chapter based on
7 those concerns on multiple occasions.
8 Ultimately met again with Richard Peto to help
9 resolve those concerns.
10 Q. All right. I'm getting there,
11 Doctor. You're jumping ahead of me. I'm
12 getting there.
13 The National Cancer Institute was
14 concerned enough that they asked for some of
15 their internal epidemiologists to take a look at
16 your chapter. Is that right?
17 A. No. That's not the reason why
18 they asked the internal epidemiologists to take
19 a look. It was part of their review prior to
20 clearance.
21 Q. Well, you know that a fellow named
22 Tarone, T-A-R-O-N-E, took a look at your
23 chapter. Is that right?
24 A. Yes, I do.
21
1 Q. Who was he?
2 A. He's one of the epidemiologists.
3 He's a statistician actually at the National
4 Cancer Institute.
5 Q. Okay. Now, he is not somebody
6 that, to your knowledge, testifies in tobacco
7 litigation. Is that right?
8 A. I don't know whether he does or
9 does not. No.
10 Q. Do you know whether he's doctor or
11 Mr. Tarone?
12 A. He is doctor.
13 Q. Okay. Doctor Tarone took a look at
14 your chapter and made some comments on it;
15 didn't he?
16 A. Yes, he did.
17 MR. LOMBARDI: I've handed
18 the witness what's been marked as 3752 for the
19 record, Your Honor.
20 Q. (By Mr. Lombardi) 3752, Doctor,
21 has a cover e-mail from Stephen Marcus. He's a
22 fellow at the NCI. Is that right?
23 A. Yes. He is an epidemiologist at
24 the NCI.
22
1 Q. Sent to you at -- via e-mail at
2 UCSD. Is that right?
3 A. That's correct.
4 Q. You see the dburns@ucsd.edu,
5 that's your e-mail address. Is that right?
6 A. That's correct.
7 Q. And then Doctor Tarone, I mean--
8 excuse me -- Stephen Marcus attaches Doctor
9 Tarone's review of your chapter. Is that right?
10 A. Yes, he did.
11 Q. And that's on the next page,
12 3752.2. Do you have that, Doctor?
13 A. I do. I should note that this
14 chapter was an earlier draft.
15 Q. We're getting there.
16 A. But with that exception, yes. It
17 was a preliminary draft of the chapter.
18 Q. We're getting there?
19 MR. LOMBARDI: If you could
20 do that first part, please.
21 Q. (By Mr. Lombardi) "Analytic
22 studies have been very consistent in showing
23 lower lung cancer risk with reduced tar
24 cigarettes."
23
1 Do you agree with that much of what
2 Doctor Tarone says?
3 A. Absolutely. That's what it says
4 in the report.
5 Q. Okay. "But the Burns, et al.,
6 chapter attributes the low risk estimates
7 obtained the analytic studies largely to bias."
8 He has that right. Is that right?
9 A. He does, and he does not. He has
10 a single focus on a specific bias. In his
11 review, we attribute it more broadly to the
12 three types of biases that I outlined earlier in
13 my testimony.
14 Q. Fair enough. You're talking about
15 in the Monograph as the chapter actually was
16 published, you talked about three lines of
17 bias. Is that right?
18 A. We talked about multiple biases.
19 In the chapter he saw, we talked about multiple
20 biases. What he's commenting on here is the
21 single bias of cigarettes per day, an increase
22 in cigarettes per day in people who switch.
23 Q. Okay. He goes on to say, "In
24 particular, Burns, et al., claim that adjustment
24
1 for smoking intensity (i.e., the number of
2 cigarettes smoked per day, induces bias because
3 people who switch to lower tar and nicotine
4 cigarettes increase the numbers of cigarettes
5 smoked per day (and analyses adjust for the
6 number of cigarettes smoked after the switch).
7 Not all studies have adjusted for smoking
8 intensity, however, and even those that do not
9 adjust for smoking intensity tend to show
10 reduced risk. Moreover, Burns, et al., present
11 little direct evidence that such bias exists,
12 even though they could have investigated the
13 presence of such bias (e.g., using the CPS-I
14 study.)"
15 That's what he wrote. Is that right?
16 A. That's what he wrote.
17 Q. Now, at that time, your draft --
18 you agree with him that you did not present
19 direct evidence of the bias in that draft of
20 your chapter. Is that right?
21 A. No. I don't agree with that.
22 Q. Well, would you agree that in the
23 monograph itself, you don't present data
24 establishing that any of the three biases that
25
1 you're talking about here actually occurs?
2 A. No. I don't agree with that
3 either.
4 Q. Okay. Let's continue. "Burns, et
5 al., conjecture that the evidence for reduced
6 risk of low tar cigarettes from the CPS-I study
7 might have resulted from such a bias in
8 adjusting for smoking intensity. It is puzzling
9 that Burns, et al., do not present direct
10 evidence for such a bias."
11 I take it from your prior answer that
12 you think Doctor Tarone just has misread the
13 draft of the chapter at this point. Is that
14 right?
15 A. That is my belief because we did,
16 indeed, discuss the efforts that we had
17 undertaken to directly resolve that issue and
18 that we had found that the data was
19 inconclusive.
20 Q. Okay. Let's look at the next
21 part. "The primary evidence presented by Burns,
22 et al., for the increase in smoking intensity
23 that follows a switch to a lower tar cigarette
24 is Figure 4-7, reporting data on men who
26
1 switched brands during the follow-up of the
2 CPS-I. It is not clear at all that the data in
3 Figure 4-7 supports the interpretation of Burns,
4 et al."
5 I take it you disagree with Doctor
6 Tarone about whether the data supports the
7 interpretation that you did. Is that right?
8 A. I certainly disagree with that as
9 an isolated interpretation. The first statement
10 is also incorrect in that that is not the source
11 of evidence that we used. But I would disagree
12 that other evidence was provided, and I would
13 also disagree that the interpretation of that
14 figure is incorrect.
15 Q. Okay. Let's go to 3752.4. Now,
16 you recall that Doctor Tarone did a similar kind
17 of calculation, or I should say, a table showing
18 the decrease in lung cancer rates versus the
19 decrease in prevalence. Is that right?
20 A. Yes, he did.
21 Q. And that's similar to what Doctor
22 Peto was pointing out. Is that right?
23 A. That's correct.
24 Q. And that's what that table is all
27
1 about. It shows that lung cancer rates are
2 decreasing faster than prevalence rates are
3 decreasing. Is that right?
4 A. I'll have to look at the actual
5 numbers as to what he says they are. Give me a
6 second, and I'll thank you.
7 Yes. These are percent reductions.
8 Q. Okay. And shows that the
9 percentages -- he takes out particular -- is the
10 right term cohorts, Doctor?
11 A. Cohorts, birth cohorts.
12 Q. Birth cohorts by age group. He
13 says, "Look at these cohorts. The lung cancer
14 rate is declining faster than the prevalent rate
15 for smoking is declining."
16 A. For two specific cohorts. That's
17 correct.
18 Q. And his point is that these are
19 important cohorts to be looking at. Correct?
20 A. Well, his interpretation is the
21 same one that Rich Peto had reached which is the
22 prevalence, per se, is not sufficient to explain
23 the change in lung cancer death rates.
24 Q. Okay.
28
1 A. And that's comething that no one
2 has disagreed with.
3 Q. You agree with that?
4 A. I agree with that. It is
5 explained by other factors besides just the
6 change in prevalence including the change in
7 initiation and rates of cessation and the
8 duration of smoking for those individuals.
14 Q. (By Mr. Lombardi) And Tarone says,
15 "It is clear that the percentage decreases in
16 lung cancer rates are larger than the decreases
17 in smoking prevalence in young men for every age
18 group. Such analyses cannot prove that lower
19 tar nicotine cigarettes reduce lung cancer rates
20 but are consistent with an added benefit beyond
21 the reductions in smoking prevalence rates in
22 time periods during which tar nicotine levels
23 were being reduced.
24 First, that's what Doctor Tarone said.
30
1 Is that right?
2 A. That's what he said.
3 Q. Did you agree with that at that
4 time?
5 A. The single observation itself is,
6 indeed, consistent. When placed in context of
7 all of the other information, that does not turn
8 out to be an explanation.
3 your concern.
4 Q. (By Mr. Lombardi) You also had
5 comments from another epidemiologist at the
6 National Cancer named Jay Lubin, L-U-B-I-N. Is
7 that correct, Doctor?
8 A. That's right. Both of these were
9 part of the peer review process that we went
10 through within the NCI.
11 Q. And part of the process of coming
12 up with Monograph 13, Chapter Four. Is that
13 correct?
14 A. Part of the process of improving
15 the quality, clarity and the consistency of the
16 text included both of these reviews. And there
17 were subsequent revisions that included the
18 appropriate pieces of these reviews.
19 Q. Okay. And I've handed you what's
20 been marked as 4326 which at the top
21 says, "Comments On Smoking Lower Yield
22 Cigarettes and Disease Risks, May 30, 2001, Jay
23 Lubin." Did I read that correctly, Doctor?
24 A. That's correct.
33
1 Q. And these are comments of Jay
2 Lubin that you received concerning your chapter
3 of the Monograph. Is that right?
4 A. They were comments that Doctor
5 Lubin and Doctor Tarone had provided when they
6 were given only Chapter Four of the Monograph
7 not all of the other chapters. That's right.
8 Q. Okay. And Doctor Lubin stated in
9 the first paragraph, "First, I want to indicate
10 my agreement with the views expressed in the
11 Tarone memo." Do you see that?
12 A. Yes.
13 Q. "The decline in age specific
14 mortality rates are greater than can be
15 explained by changes in smoking prevalence and
16 are consistent with a small impact on risk of
17 the decrease in cigarette tar content."
18 A. That's what he says. Yes. That's
19 correct.
20 Q. Okay. Let's read the beginning of
21 the next paragraph. "In my view, the
22 description of the epidemiological evidence by
23 Burns, et al., in this chapter needs to be
24 better balanced and, arguably, does not support
34
1 their suggestion of an increased risk in smokers
2 who switch to low tar brands. Burns, et al.,
3 seem too quick to dismiss the epidemiology
4 without adequately demonstrating the claimed
5 bias from improper adjustment for smoking
6 rates."
7 Do you see that?
8 A. I see that.
9 Q. And I assume that you disagreed
10 with that comment at the time you received this
11 paper from Doctor Lubin. Is that right?
12 A. I disagreed with pieces of that
13 comment. Number one, we did not claim an
14 increased risk to smokers who switched to a low
15 tar brand. And, number two, we didn't dismiss
16 the epidemiology. We did, however, take this
17 comment to heart; and we subsequently made
18 another major revision of the chapter that laid
19 out in much more detail and with much greater
20 clarity, I would hope, the epidemiological
21 concerns.
22 Q. I'm getting there, Doctor. Let's
23 go to the next one. "As suggested by Peto's
24 letter and Tarone's analysis of data in Table
35
1 4-9, declines in lung cancer mortality rates are
2 not entirely explained by the changes in smoking
3 prevalence. And reductions of tar levels are
4 the most likely contributing factor."
5 Did you agree with that at the time
6 Doctor Lubin provided this paper to you?
7 A. I agreed with the first part of
8 that. We did an extensive discussion and
9 analysis to examine the second part of that and
10 disagreed with the second part.
11 Q. Okay. "Complex modeling and
12 adjustment of complex confounding factors play
13 an important role in the analysis of
14 epidemiological data; however, the simple
15 presentation of rates by Peto and by Tarone are
16 powerful arguments in support of some small
17 beneficial effect of tar reduction."
18 My question, Doctor, is do you agree
19 that the presentation of rates by Peto and
20 Tarone are powerful arguments in support of some
21 small beneficial effect of tar reduction?
22 A. No. I don't agree with that
23 because it only deals with one element of the
24 determinates of risk of lung cancer, that is the
36
1 smoking prevalence at a specific age. It does
2 not deal with the age of initiation of those
3 individuals, the intensity of their smoking
4 early in life or the duration of their smoking.
5 Q. Now, Doctor, I think that you
6 should still have up there a group of e-mails we
7 talked about this morning. That is Exhibit
8 number 4430. These are the ones involving you
9 and Doctor Thun.
10 A. If I do, I have misplaced it. I
11 apologize. Well, maybe it's underneath this.
12 Yes. Here they are.
13 Q. Thank you. And we already looked
14 at one where you were responding to Doctor Thun,
15 so we won't do that again, Doctor. But let's
16 look at Bates page HHA. Well, let me strike the
17 question.
18 Tarone and Lubin commented on the
19 draft, is that right, in about May of 2001?
20 A. They commented on the draft that
21 they had received. That's right.
22 Q. And did someone at the NCI suggest
23 you need to have a meeting to talk about this
24 draft to try and work out people's differences
37
1 of opinion?
2 A. That's, I think, an incorrect
3 linkage. There was, indeed, a meeting. It was
4 a meeting of convenience, and it was an effort
5 to have a better and more open discussion of the
6 specific issue of whether the decline in
7 prevalence, the decline in lung cancer rates in
8 the UK and the slower decline in prevalence was
9 an obligatory -- that the only or most likely
10 conclusion from that observation was an effect
11 of low tar and nicotine cigarettes.
12 Q. Well, at any rate, however it
13 happened, there was a meeting among people who
14 had reviewed your chapter that took place in
15 Toronto. Is that right?
16 A. Well, there was a meeting of
17 several individuals including some who had
18 reviewed the chapter. Yes.
19 Q. And there was -- I don't know the
20 name of the organization. But an
21 epidemiological organization was having a
22 meeting in Toronto. Is that right?
23 A. That's correct.
24 Q. So a lot of you folks were there
38
1 at the time?
2 A. That's correct.
3 Q. Including Richard Peto?
4 A. That's correct.
5 Q. Were Lubin and Tarone there?
6 A. No.
7 Q. Okay. Lubin, by the way, does he
8 testify against tobacco companies?
9 A. I don't know.
10 Q. Okay. And so someone named
11 Jonathan Samet was also at the meeting. Is that
12 right?
13 A. Yes, he was.
14 Q. And up to this time, Jonathan
15 Samet had not been involved in your chapter of
16 the Monograph. Is that right?
17 A. No. That's not right.
18 Q. Well, Doctor Samet was asked to be
19 at the meeting by people at the NCI?
20 A. Yes, he was.
21 Q. And he was asked to help figure
22 out if there was a way to compromise on the
23 conclusions of the Monograph chapter. Is that
24 right?
39
1 A. No. That's not right.
2 Q. Okay. Well, you went to this
3 meeting in Toronto. And did you think you had
4 reached a consensus as a result of this meeting?
5 A. I'm not quite sure what your
6 question refers to. The meeting in Toronto was
7 to air various views. That was not intended to
8 rewrite the text of the Monograph. I believe
9 that we had reached some common understanding,
10 and that we had a consensus at the end of the
11 meeting. Yes.
12 Q. So at the meeting -- at this
13 meeting, a consensus was reached. Is that
14 right?
15 A. At the meeting, the consensus was
16 reached on the single issue that was discussed
17 at the meeting which was whether the decline in
18 smoking and decline in lung cancer death rates
19 being larger in percent than the decline in
20 smoking prevalence in the UK among younger aged
21 groups of males, whether the only explanation of
22 that was that of a lower tar cigarette having
23 reduced disease risks. We did reach a
24 conclusion that there were other potential
40
1 explanations that were as, and probably more
2 likely. And they included declines in
3 initiation, lower intensity, smoking at earlier
4 ages of initiation and cessation on the part of
5 individuals who had taken up smoking.
6 Q. Okay. All right, Doctor. Now,
7 after the meeting, you continued to have
8 conversations with Doctor Thun about the draft.
9 Is that right?
10 A. Among others, yes.
11 Q. And let me just -- I'm just going
12 to ask you for context purposes to look at the
13 page that's HHA 6740080. Do you have that?
14 A. Yes.
15 Q. Okay. And that's from Doctor Thun
16 to you. Is that right?
17 A. Yes.
18 Q. And those are comments that he had
19 on the chapter of the Monograph. Is that right?
20 A. On the draft that he had at that
21 moment in time, yes.
22 Q. And then we go back to HHA6740074,
23 and that's your response. Is that right?
24 A. I can't tell you specifically from
41
1 memory. I assume it is. I'd have to look at
2 the dates, but it probably is. Yeah.
3 Q. Okay. We'll look at it, and maybe
4 it will help you determine that. At the bottom
5 of HHA6740074, is a message from Doctor Thun to
6 yourself. Do you see that? And he thanks you
7 for your prompt reply, and he says, "Attached is
8 a Word document" that talks about the chapter of
9 the Monograph. Correct?
10 A. That's correct.
11 Q. And at the top is your response to
12 that e-mail from Doctor Thun. Is that right?
13 A. Yes. That's correct.
14 Q. Dated July 26, 2001. Is that
15 right?
16 A. That's correct.
17 Q. And you point out that you have
18 read a portion of -- you have concerns about a
19 portion of Doctor Thun's comments that you're
20 noting there. Is that right?
21 A. Specifically what I'm saying is
22 that I have concerns about the language he's
23 chosen, and I want to be sure that what he is
24 saying is consistent with the way I read that
42
1 particular language.
2 Q. Okay. And you say, "I am reading
3 quote." And this is where you're quoting from
4 him. Is that right?
5 A. Yes.
6 Q. "They provide a comparison of
7 different eras that helps to put into
8 perspective the relatively small impact of
9 changes in cigarette design compared to more
10 powerful adverse changes in smoking behavior."
11 And that's the end of what you're quoting from
12 his comments. Is that right?
13 A. That's correct.
14 Q. Then you go on to say -- this is
15 you talking -- "This seems to conclude that here
16 is a small beneficial effect of cigarette design
17 changes. And since the analysis was controlled
18 for smoking behaviors, it is not clear to me
19 what the more powerful adverse changes in
20 smoking behavior refers to."
21 Your concern is that he is attributing
22 a small beneficial effect of cigarette design
23 changes to the decrease in lung cancer rates. Is
24 that right?
43
1 A. I think you may want to rephrase
2 that. As I understand it, it doesn't make any
3 sense.
4 Q. That's fine. I'll rephrase. And
5 that's fair. If you don't understand the
6 question, just tell me.
7 What you're concerned about, you're
8 telling him that you're concerned that what he's
9 commenting to you indicates that there is a
10 small beneficial effect of cigarette design
11 changes?
12 A. What I'm saying is that I don't
13 believe that Michael actually meant what he was
14 saying. I'm asking him, "Is this actually what
15 you meant to say?" Did he really mean to say
16 that you believe there are these small design
17 changes?
18 That sentence can be read in two
19 contexts. One, it can be read in the context
20 that they only look at the whole picture, it's
21 clearly bad, a global context. Or it can be
22 parsed out into a specific context that says the
23 changes are small but real, and they're
24 overwhelmed by these other changes. What I'm
44
1 asking him is which of those two are you
2 saying? Are you really saying that you believe
3 that there is a small risk reduction?
4 That was, as was pointed out earlier,
5 one of the issues that we were repetitively
6 interacting with each other about. It was the
7 questions we were asking in the Monograph. It
8 was extensively discussed again and again and
9 again.
10 Q. And you were worried, even after
11 all this discussion, you were worried that
12 Doctor Thun believed that there was a small
13 beneficial effect?
14 A. No. I was worried that the
15 language he was suggesting might not be what he
16 actually believed to be true and that it would
17 be subject to misinterpretation because he had
18 looked at it as a global sense rather than
19 parsing out the specific language. I was,
20 therefore, asking him is this what you really
21 mean?
22 Q. But you didn't quite put it in
23 those words. Correct?
24 A. Well, it's says this seems to
45
1 conclude here. I would interpret that as
2 saying, "Is this what you really mean?"
3 Q. Let's go to the last sentence. It
4 says, "The changes you're suggesting require
5 rewriting the volume and conclusions
6 particularly framing the discussion as an
7 alternative to nicotine replacement therapy and
8 would require review as a new document from the
9 start." That's what you said to him. Right?
10 A. Yes. But that does not apply to
11 the previous discussion. One of the other
12 comments that Michael had had was that what we
13 ought to do is not look at this as to whether
14 they're different from regular cigarettes and
15 light cigarettes. What we ought to do is look
16 at the light cigarettes as an alternative to
17 nicotine replacement therapy and cessation.
18 Then we would have this unequivocal conclusion
19 that light cigarettes are much worse than
20 nicotine replacement and much worse than
21 cessation.
22 The point I was making to him was that
23 that's a whole other discussion. That's not
24 what this volume is about. That's not what we
46
1 reviewed.
2 Q. Well, in any event, you were not
3 in favor of rewriting the entire volume at that
4 point. Is that right?
5 A. I was in favor of answering the
6 question we had been given to answer not
7 redefining the question to a different question.
8 Q. After all you had been through
9 with Peto and Tarone and Lubin and Samet and
10 meeting in Toronto, you did not want to start
11 with a new document. Is that right?
19 Q. (By Mr. Lombardi) In any event,
20 Doctor, would you agree with me that the
21 conclusions that are expressed in Monograph 13
22 are a compromise. Is that fair?
23 A. I don't believe that they are a
24 compromise, and I don't believe that's an
47
1 appropriate term to use for the process that we
2 arrived at those conclusions with. They are the
3 best, the clearest and most accurate statement
4 of the science that we could make with all of us
5 adjusting the words so that they were as
6 accurate and as clear as possible. Okay, yes.
7 That means that if somebody suggests one word
8 and another person suggests another word, we
9 find a way to bridge that gap. But I don't see
10 that as a compromise. I see that as an effort
11 to improve clarity.
12 Q. Okay. Who wrote the conclusions
13 themselves?
14 A. We did it jointly.
15 Q. Did Doctor Samet have a role in
16 that?
17 A. Yes, he did.
18 Q. Okay. And the conclusion, the
19 final conclusion, is that "There is no
20 convincing evidence that changes in cigarette
21 design between 1950 and the mid 1980's have
22 resulted in an important decrease in the disease
23 burden caused by cigarette use either for
24 smokers as a group or for the whole
48
1 population." Is that right?
2 A. That's correct.
3 Q. And so the conclusion was that
4 there -- simply at this point, based on your
5 analysis in the Monograph, Chapter Four of
6 Monograph, there is no reason to believe there
7 is a benefit to low tar cigarettes. Is that
8 right?
9 A. Your question has two parts in
10 it. The first part of your question is the
11 conclusions are not based on the analysis we did
12 on the Monograph. They are based on all the
13 evidence presented, and they're based on all the
14 evidence and all of the chapters of the
15 Monograph.
16 Secondly, you are correct that the
17 conclusion is that the evidence does not support
18 a reduction in disease risk.
19 Q. And that's the first time that a
20 government document has come to that conclusion.
21 Is that right?
22 A. That is the first time that it has
23 been expressed that clearly. Yes. The IOM
24 report which was done at the behest of the
49
1 government came to a similar conclusion about a
2 year earlier but did not express it as clearly.
3 Q. Now, Doctor, you talked some about
4 cigarette design back in the 1970's and the time
5 you worked on the Surgeon General's Report in
6 1981. You did not mean to suggest to this Court
7 that you were unaware at that time of the design
8 features that were used to lower tar and
9 nicotine in lower yield cigarettes. Is that
10 right?
11 A. I would not suggest to the Court
12 that I had no knowledge on that issue. I would
13 suggest to the Court that my knowledge, both of
14 the specifics of those issues, the ramifications
15 for people who use the products and the
16 relationship between those changes and the
17 individual has changed substantially over time.
18 Q. Okay. In fact, in the 1981
19 Surgeon General's Report, you dealt with
20 cigarette design features specifically. Didn't
21 you, Doctor?
22 A. We dealt with some limited
23 specific design features, most notably, the
24 holes in filters, and the likelihood that those
50
1 holes would be occluded.
2 Q. You did deal with that. That's
3 what you're saying?
4 A. That's correct.
5 Q. I just hadn't heard you.
6 All right. You've been handed what's
7 been marked Exhibit 7078, Doctor. And without
8 asking you to look through the whole thing, can
9 you tell from a quick review that that is the
10 1981 Surgeon General's Report?
11 A. That appears to be the report.
12 Q. Okay. And this is a report on
13 which you were -- I'm not going to even try to
14 get the title exactly correct, Doctor -- but
15 some sort of editor. Is that right?
16 A. Yes. I was one of three
17 consulting scientific editors.
18 Q. Okay. Would you look at page
19 forty-nine of the report?
20 A. Certainly.
21 MR. LOMBARDI: 7078.67
22 please. I'm actually looking down at the bottom
23 of the page, Janelle. Well actually, let's go
24 on back up there.
51
1 Q. (By Mr. Lombardi) You see in the
2 middle of the page, Doctor, there is a paragraph
3 there?
4 A. Yes.
5 Q. And this reflects your knowledge
6 and the Surgeon General's knowledge of the fact
7 that compensation is a phenomenon that's out
8 there and effects smokers of low yield
9 cigarettes. Is that right?
10 A. Absolutely. We had a primitive
11 knowledge of compensation at that time.
12 Q. Okay. Well, what you say is you
13 say, "Human smoking patterns are diverse and
14 span a wide range from one individual to
15 another." Now, you agree with that today even.
16 Is that right?
17 A. That's correct.
18 Q. Smoking patterns vary from
19 individual to individual. Is that right?
20 A. They certainly do.
21 Q. That's true in Illinois as well as
22 anywhere else?
23 A. That's correct.
24 Q. So one member of this class is
52
1 going to smoke differently than another member
2 of this class. Is that right?
3 A. That's correct.
4 Q. And one member of this class may
5 smoke differently from cigarette to cigarette.
6 Is that right?
7 A. That's also correct.
8 Q. Okay. And you go on to say -- I
9 don't know. Did you draft this particular
10 portion?
11 A. I can't tell you. My guess is I
12 probably did not.
13 Q. Well, the report goes on to say
14 that "Some individuals compensate for lower
15 yield cigarettes by changing their style of
16 smoking." Do you see that?
17 A. Yes.
18 Q. And that's referring -- that's the
19 same concept of compensation that we talked
20 about today. Is that right?
21 A. No. It's actually not. At that
22 time, we thought the compensation was because of
23 changes in factors like the resistance to draw
24 on the cigarette or covering or not covering the
53
1 holes. At that time, we did not understand that
2 the addiction itself defines the way people
3 smoke the cigarette; that is, that people will
4 sense the nicotine as it comes into the back of
5 their throat and change the way they are drawing
6 on the cigarette within the puff and within the
7 cigarette to preserve the nicotine dose. That
8 was a concept of compensation that was
9 completely different than the one that we had at
10 this time which was simply mechanical
11 compensation which is that if you have a lower
12 resistance to draw, you'll take a bigger puff.
13 Q. When you talk about addiction,
14 you're talking about addiction to nicotine. Is
15 that right?
16 A. That's correct.
17 Q. And what was missing at this time
18 was an understanding that smokers are smoking
19 for nicotine and that effected the way they
20 smoked the cigarette?
21 A. No. What was missing was the
22 precision and specificity of the link between
23 the addiction and the need to preserve nicotine
24 use and the way that altered the pattern of
54
1 smoking for the individual. We thought at this
2 time that individuals smoked to get nicotine;
3 so, in general, they would smoke enough
4 cigarettes to get a certain dose of nicotine.
5 We did not appreciate the fact that when
6 individuals draw on a cigarette, they perceive
7 nicotine at sensors in the back of their
8 throat. And, therefore, if they're not getting
9 enough nicotine within that single puff, they
10 will draw faster, harder and take a bigger puff
11 in order to increase the amount of nicotine
12 delivered to their lungs.
13 That type of compensation is one that
14 is much more specific and is much more likely to
15 lead to complete compensation in terms of
16 delivery of nicotine and tar. And it wasn't
17 until we got a much better understanding of both
18 addiction later on in the 1988 report and later,
19 as well as a better understanding of how the
20 mechanical and design changes of the cigarette
21 impacted the delivery with these different
22 patterns of puffing, that we began to understand
23 these issues better.
24 Q. And so you're saying that the
55
1 Surgeon General and the people that worked on
2 the Surgeon General's Report weren't aware of
3 all this at the time they worked on the report
4 in 1981. Is that right?
5 A. We were aware of what's expressed
6 here. What's expressed here is a very primitive
7 understanding of the linkages between addiction
8 and compensation through the design
9 characteristics of the cigarette.
10 Q. Did you have a chance to read any
11 consumer literature about cigarettes during your
12 time with the Surgeon General?
13 A. Episodically, yes.
14 Q. Did you ever read CONSUMER REPORT?
15 A. Yes.
16 Q. Did you ever see an article from
17 1976 called "Less Tar, Less Nicotine: Is That
18 Good?"
19 A. No.
20 Q. Have you seen this document before
21 that I just put in front of you?
22 A. I can't tell you that I have. I
23 don't recall.
24 Q. Well, let's look at it and see
56
1 what was known in the consumer literature.
20 Q. (By Mr. Lombardi) Okay. Here's
21 the -- you can tell by looking up at the
22 screen. What I've got on the screen is the same
23 thing you've got before you. Is that right?
24 A. I don't know. I assume it is.
58
1 Q. Okay. Well, you can see the title
2 is the same. Is that right, Doctor?
3 A. I have no reason to expect that it
4 is different in any way.
5 Q. Okay. Thank you, Doctor. Well,
6 let's look at the first highlighted part and see
7 what they're saying in the consumer literature
8 about nicotine. "When cigarette smoke contains
9 less nicotine than such smokers are accustomed
10 to, their bodies simply contrive ways to get
11 more smoke." Do you see that?
12 A. Yes.
13 Q. That's describing the fact that
14 nicotine is what the people are smoking for. Is
15 that right?
16 A. That's correct.
17 Q. And they adjust their behavior to
18 get more nicotine. Is that right?
19 A. That's correct.
20 Q. Okay. Let's go to the next page.
7 Q. (By Mr. Lombardi) Okay. Let's
8 look at that first highlighed portion.
9 MR. LOMBARDI: Actually,
10 give the Doctor a little bit more, Janelle.
11 Actually, I want to go above so he can see about
12 Psychopharmacologia.
13 Q. "The first study demonstrating the
14 influence of nicotine content on cigarette
15 consumption appeared in the English edition
16 Psychopharmacolegia in 1971." Do you see that?
17 A. Yes.
18 Q. I'm sure I didn't pronounce that
19 right, Doctor.
20 A. I thought you did pretty well.
21 Q. Thank you. Actually, there were
22 studies about nicotine content and cigarettes
23 going all the way back to the 1940's. Is that
24 right?
60
1 A. Yes. That's correct.
2 Q. And there were studies on
3 compensation in the fifties and the sixties and
4 the seventies. Is that right?
5 A. Very broadly, yes.
6 Q. Okay. And it goes on to say that
7 "Smokers in the experiment received low,
8 moderate or high nicotine cigarettes on
9 different days, and the number of cigarettes
10 smoked was then compared. Results: The less
11 nicotine in the cigarette smoke, the more
12 cigarettes were smoked per day." Do you see
13 that?
14 A. Yes. These were experimental
15 cigarettes. Yes.
16 Q. That's fair, Doctor. But what
17 they're talking about is they smoked more
18 cigarettes because they're getting less nicotine
19 from each cigarette. Is that right?
20 A. That's correct.
21 Q. And they wanted to get more
22 nicotine?
23 A. That's also correct.
24 Q. Okay. Let's go down to the next
61
1 one.
2 THE COURT: What's correct?
3 That conclusion or that statement made that is
4 so stated?
5 A. It's correct that it makes that
6 statement.
7 Q. (By Mr. Lombardi) Well, it's also
8 correct the conclusion is correct; isn't it?
9 A. That people compensate?
10 Q. Yes.
11 A. Yes.
12 Q. By smoking more cigarettes?
13 A. On an absolute level with today's
14 knowledge, absolutely.
15 Q. Because they want more nicotine?
16 A. It is nicotine that drives the
17 compensation. Yes.
18 Q. And you agree with that?
19 A. I agree with that based on current
20 data. That's correct.
21 Q. And you knew that in the 1970's;
22 didn't you, Doctor?
23 A. No, we didn't.
24 Q. Okay. So anyway, CONSUMER REPORT
62
1 appears to be reporting it, but you weren't
2 aware of it. Is that right?
3 A. No. You're misstating my
4 testimony.
5 Q. Well, let me go next. Let's go to
6 the next part.
7 A. I mean I'd be happy to clear it
8 up.
9 THE COURT: Just wait for
10 the question.
11 Q. (By Mr. Lombardi) The next thing
12 is you say, "The increase in the number of
13 cigarettes smoked does not fully compensate for
14 the decrease in nicotine yield. When the
15 nicotine yield is cut in half, the number of
16 cigarettes smoked does not double, either in
17 laboratory tests or in the marketplace. But
18 nicotine intake is also increased by other
19 adjustments in smoking patterns."
20 Do you see that?
21 A. Yes.
22 Q. And that's something that you're
23 aware of today. Is that right?
24 A. That's correct.
63
1 Q. And you were aware of this in the
2 1970's; weren't you?
3 A. I was aware of this article in the
4 1980's. Yes.
5 Q. I thought you said you had never
6 seen this article before.
7 A. The article that you're referring
8 to in the scientific literature, not this
9 article in CONSUMER REPORT.
10 Q. Okay. I understand. Okay. Then
11 let's go on down. It talks about various
12 methods by which a smoker gets more nicotine
13 from a cigarette. Is that right?
14 A. That's correct.
15 Q. It says, "Smokers often smoke a
16 low nicotine cigarette to a shorter butt." Do
17 you see that?
18 A. Yes.
19 Q. Okay. And that means they're
20 smoking more of the cigarette to get more
21 nicotine. Is that right, Doctor?
22 A. That's correct.
23 MR. LOMBARDI: Next one.
24 Q. (By Mr. Lombardi) "Some smokers
64
1 also increase the size of each puff, thus
2 increasing the nicotine dose per puff."
3 You were just talking about that a
4 minute ago?
5 A. Yes.
6 Q. If you increase the size of the
7 puff, you get more nicotine?
8 A. That's correct.
9 Q. That's something you knew about in
10 the 1970's; isn't it, Doctor?
11 A. We knew that smokers did that.
12 Yes.
13 Q. "Some shorten the interval between
14 puffs, thus increasing the dose per minute."
15 That's getting more nicotine. Right,
16 Doctor?
17 A. That's correct.
18 Q. And you knew that in the 1970's?
19 A. We knew that that behavior
20 occurred in people who used different
21 experimental cigarettes. We didn't know the
22 extent to which that compensated for the decline
23 in nicotine yield.
24 Q. But at any rate, the article goes
65
1 on to say, "There are also other ways to
2 compensate for a drop in nicotine yield by
3 drawing the smoke deeper into the lungs for
4 example or by holding it there longer before
5 inhaling."
6 You knew that in the 1970's; didn't
7 you, Doctor?
8 A. We knew that those were potential
9 ways. We didn't know that they were actually
10 used.
11 Q. Okay. "In short, human smokers
12 are not smoking machines. They do not
13 necessarily smoke a low nicotine cigarette in
14 the same way they smoke a high nicotine
15 cigarette, nor do they smoke the same number of
16 cigarettes when they switch from a low nicotine
17 brand from a high nicotine brand."
18 A. That's correct.
19 Q. And you knew all that in the
20 1970's. Isn't that right?
21 A. I don't believe that we knew that
22 to the clarity with which it's being expressed
23 in CONSUMER REPORT. The scientific literature
24 was considerably more ambiguous on those points
66
1 at that time. And it particularly was ambiguous
2 on the question of what mechanism, that is was
3 it simply a response to design or was it a
4 relationship between the perception of nicotine
5 and the need to preserve nicotine and the actual
6 changes in the puff volume, puff intensity of
7 the cigarette.
8 Q. But at least you knew in the
9 1970's that people were smoking for nicotine.
10 Is that right?
11 A. Yes.
12 Q. And they could alter their smoking
13 behavior, meaning their puff size, the puff
14 volume, the number of puffs in order to get more
15 nicotine. Is that right?
16 A. We knew that they could do that,
17 and we knew that when they did do that, they got
18 more nicotine. We did not understand the
19 relationship between addiction and their
20 involuntary changes in their smoking behavior.
21 Q. So you knew that cigarettes, as
22 designed in the 1970's, permitted people to get
23 different amounts of nicotine?
24 A. That's always been true. Yes.
67
1 Q. You have always known that
2 cigarettes had designs that permitted to get --
3 permitted different smokers to get different
4 amounts of smoke. Isn't that right?
5 A. We have always known that an
6 individual could derive different amounts from a
7 single cigarette. We had always expected or we
8 had expected at that point in time when an
9 individual shifted from one type of cigarette to
10 another, that their pattern would not change
11 sufficiently to preserve their dose and,
12 therefore, they would get a lower dose. That is
13 what we concluded five or six years later in
14 1981 based on reviewing this same body of
15 evidence.
16 Q. Okay. Well, you didn't see this
17 consumer -- well, the articles referencing
18 CONSUMER REPORT, you say you didn't see until
19 after the '81 Surgeon General's Report. Is that
20 right?
21 A. No. That's not what I said. What
22 I said was I didn't see the CONSUMER REPORT
23 article. The CONSUMER REPORT article is
24 discussing articles that have been published in
68
1 the scientific literature. Those were included
2 in the Surgeon General's Report.
3 Q. I'm sorry. I'm confused. Are you
4 saying you did see the scientific articles
5 underlying the CONSUMER REPORT's article in the
6 1970's?
7 A. Well, probably at the end of the
8 seventies or early eighties, but yes. I saw
9 them as part of the process of producing the '81
10 report.
11 Q. And you knew in the 1970's that
12 the way tobacco -- the way cigarettes, lower
13 yield cigarettes, were decreasing yield were
14 based on a series of design features. Is that
15 right?
16 A. We had a partial understanding of
17 the mechanism by which cigarettes were designed
18 to produce lower yield. We had a very limited
19 understanding of the interaction between the
20 smoker's addiction and those design features.
21 Q. Well, you knew. You knew that the
22 cigarettes used filters. Is that right?
23 A. Well, we knew that many of the
24 cigarettes on the market had filters. Yes.
69
1 Q. But filters were one of the ways
2 of bringing down the tar level. You knew that?
3 A. That's correct.
4 Q. And you knew that those filters
5 had ventilation holes?
6 A. Yes.
7 Q. You knew those ventilation holes
8 were used to dilute the smoke with air, and that
9 helped bring down the tar yields. Is that
10 right?
11 A. Bring down the tar yields in
12 machines. Yes.
13 Q. You knew that in the 1970's. Is
14 that right?
15 A. We knew that those factors were
16 used to reduce the tar yields in the machines.
17 Yes.
18 Q. And you knew that those cigarettes
19 used something called porous paper?
20 A. Yes.
21 Q. And porous paper also permitted
22 air to come into the tobacco into the rod of the
23 cigarette and help dilute the smoke and resulted
24 in lower tar yields?
70
1 A. That's correct.
2 Q. And you knew the porous paper also
3 had the benefit of letting some gasses out. Is
4 that right?
5 A. That's correct.
6 Q. And you knew that cigarettes used
7 reconstituted tobacco?
8 A. We did.
9 Q. You knew that in the 1970's?
10 A. That's correct.
11 Q. And reconstituted tobacco was
12 another way that you brought down the tar yields
13 of these cigarettes. Is that right?
14 A. That's one of the ways tar yields
15 were reduced. That's correct.
16 Q. And you knew that these cigarettes
17 used expanded tobacco?
18 A. We did.
19 Q. And you knew that expanded --
20 THE COURT: What was your
21 answer to that?
22 A. We did.
23 Q. (By Mr. Lombardi) And you knew
24 that in 1970. Correct, Doctor?
71
1 A. That's correct.
21 Q. (By Mr. Lombardi) I think we're on
22 expanded tobacco, Doctor Burns. I think you
23 said it; but just to make sure we're on the same
24 page, you were aware that expanded tobacco was
73
1 used in the cigarettes of the 1970's to lower
2 tar yields. Is that right?
3 A. Yes, I was.
4 Q. And expanded tobacco has the
5 effect of meaning that there is less tobacco in
6 the cigarette rod. Is that right?
7 A. That was one of the thoughts we
8 had. Yes.
9 Q. Okay. And that, in turn, means
10 that there would be less tar when that expanded
11 tobacco was lit and smoke came off of it. Is
12 that right?
13 A. That was our understanding at that
14 time. Yes.
15 Q. Now, the design of low tar
16 cigarettes was specifically discussed in the
17 Monograph. Is that right?
18 A. That's correct.
19 Q. In the chapter done by Doctor Lynn
20 Kozlowski. Is that correct?
21 A. That's correct.
22 Q. Chapter Two of the Monograph?
23 A. Yes.
24 Q. Do you still have the Monograph up
74
1 there, Doctor? I think it's on the bottom
2 there.
3 A. Yes, I do.
4 Q. And if you can find Chapter Two, I
5 think it's on page thirteen.
6 A. Okay.
7 Q. And that's what I got up there on
8 the screen too. Right, Doctor? Cigarette
9 Design, Lynn Kozlowski and others. Is that
10 right, Doctor?
11 A. That's correct.
12 Q. And Doctor Kozlowski specifically
13 talks about this question about whether the
14 cigarette design used to bring down tar levels
15 were a secret; doesn't he?
16 A. He describes what was known.
17 Yes. And he describes that we know a great deal
18 about that process.
19 Q. Okay. Page fifteen, 7109.30,
20 Doctor Kozlowski -- well, first of all, let's
21 just set it up. The table -- I'm sorry,
22 Doctor. Tell me when you're there.
23 A. I'm there.
24 Q. Table 2.2 talks about the ways
75
1 that you reduce tar and nicotine yield in
2 cigarettes. Is that right?
3 A. Machine measured. Yes.
4 Q. And he goes through many of the
5 things you and I just discussed. Is that right?
6 A. Yes.
7 Q. Okay. Then if you go down to the
8 bottom of that page, Doctor Kozlowski says, "The
9 design features listed in Table 2.2 should not
10 be considered secrets of cigarette
11 manufacturers."
12 A. Yes.
13 Q. "Many of these design
14 characteristics were discussed in a classic book
15 on tobacco and tobacco smoke by Wynder and
16 Hoffman in 1967 and more recently by Brown in
17 1990." Do you see that?
18 A. I see that.
19 Q. You don't disagree with Doctor
20 Kozlowski that the design features used to make
21 cigarettes into low tar cigarettes were not a
22 secret; do you?
23 A. I think you're misinterpreting
24 what Doctor Kozlowski is saying. What he's
76
1 saying is that cigarette manufacturers claim
2 these things as trade secrets. And they should
3 not be claimed as trade secrets because they are
4 well recognized phenomenon. He is also saying
5 that while we know them generally, that is we
6 know from work that has been published what
7 happens when you make a single change in an
8 experimental cigarette, we have very little
9 understanding of the brand's specific
10 characteristic of these changes that are present
11 in each brand.
12 Q. The brand characteristics, that
13 would be a trade secret. Wouldn't it?
14 A. I think what Doctor Kozlowski --
15 Q. No. I'm asking you, Doctor.
16 A. Should that be a trade secret?
17 Q. The brand characteristics?
18 A. If it is? My understanding, the
19 tobacco industry claims that it is. Yes.
20 Q. Okay. Actually, what the doctor
21 says is after he said it should not be
22 considered a design secret, he says many of the
23 design characteristics were discussed in a book
24 in 1967; doesn't he?
77
1 A. He does.
2 Q. So those design characteristics
3 were known throughout the 1970's. Weren't they,
4 Doctor?
5 A. The potential for those individual
6 design changes to alter tar levels was known.
7 Yes.
8 Q. Now, you made some reference to
9 the vent hole blocking in your Direct
10 Examination. Do you remember that?
11 A. I did.
12 Q. You did not mean to suggest to
13 this Court that there is any evidence that vent
14 hole blocking is a problem with light
15 cigarettes. Is that right?
16 A. I don't know what you mean.
17 Q. Well, you're not testifying --
18 A. It certainly, in my experience and
19 my reading of the literature, occurs with light
20 cigarettes. When it occurs, it increases the
21 tar value beyond that which the machine yields.
22 Q. Vent blocking is not a significant
23 problem with light cigarettes. Is it, Doctor?
24 A. I'm not sure what you mean. It
78
1 certainly can change the yield of the
2 cigarette. It certainly occurs, and it occurs
3 with a reasonable frequency.
4 Q. Well, you read Chapter Two before
5 it was published. Is that right?
6 A. That's correct.
7 Q. All right. Let's go to page
8 twenty-eight, 7109.43.
9 A. Twenty-eight?
10 Q. Yes, twenty-eight.
11 A. Okay.
12 Q. And the last full paragraph at the
13 bottom of the page talks about vent hole
14 blocking; doesn't it, Doctor?
15 A. Yes.
16 Q. And it says "Reviewing the
17 literature, vent blocking appears to be a
18 significant mode of compensation for reduced
19 yield among smokers of the lowest tar
20 cigarettes, e.g. one milligram FTC tar.
21 Do you see that?
22 A. Yes.
23 Q. And that's not Marlboro Light or
24 Cambridge Light. Correct?
79
1 A. That's correct.
2 Q. And then it says, "But not likely
3 among most smokers of light and ultra light
4 cigarette brands." Do you see that?
5 A. Yes.
6 Q. Do you accept that conclusion of
7 Doctor Kozlowski that was expressed in the
8 Monograph?
9 A. Well, number one, that's not a
10 conclusion. It is an observation. But yes. I
11 accept that observation.
12 Q. And you know, Doctor, because you
13 had to read this chapter before it came out.
14 Didn't you?
15 A. Yes.
16 Q. You know that Doctor Kozlowski
17 cites two studies dealing specifically with
18 Marlboro Lights; don't you?
19 A. That's correct.
20 Q. And in both situations, both
21 studies, Doctor Kozlowski found that there was
22 no vent hole blocking, no significant vent hole
23 blocking, with Marlboro Light smokers. Is that
24 right?
80
1 A. I believe he found that there was
2 less than with the ultra lights, and that the
3 mechanism of compensation of reducing the
4 dilution was based on the faster draw rate.
5 Q. I missed your last word, Doctor.
6 I'm sorry.
7 A. Rate. The faster draw rate.
8 Q. Draw rate. And so, Doctor, just
9 to confirm page 257109.40.
10 A. Twenty-five?
11 Q. Twenty-five of the Monograph. Do
12 you have that?
13 A. Yes.
14 Q. And the paragraph I'm looking at
15 is the first full paragraph.
16 A. Yes.
17 Q. And does that -- is that one of
18 the studies that talks specifically about
19 Marlboro Lights?
20 A. Give me a chance to read it, and
21 I'll let you know.
22 Well, the first study is one that does
23 not deal with the frequency of vent hole
24 blocking. It simply deals with the effects of
81
1 vent hole blocking on carbon monoxide levels
2 with the two products.
3 Let me lead the second study.
4 Q. We can just stop with the first
5 one. The effect was that there was no added
6 effect on carbon monoxide exposure from Marlboro
7 Light. Is that right?
8 A. No. The effect was that when you
9 block both products, you didn't see an increase
10 in carbon monoxide levels with Marlboro Lights
11 but you did with the ultra light. Or I'm
12 sorry. I'm sorry. With the Now brand.
13 Q. With the Now brand. And that is
14 the way that, at least these two people, Sweeney
15 and Kozlowski, were studying to see the effects
16 of vent hole blocking in that particular study.
17 Is that right?
18 A. They were examining the effect of
19 vent hole blocking on the levels of carbon
20 monoxide generated, not on tar and nicotine.
21 Q. But that's the way he was
22 measuring to see the effects of vent hole
23 blocking in that study. Is that right?
24 A. No. That's what he was
82
1 measuring. He was looking at when you block the
2 vent, do you change the level of carbon
3 monoxide.
4 Q. Okay. Let's look at page
5 twenty-four please, 7109.39. This one says --
6 this is Sweeney and Kozlowski again -- "Examined
7 the effect of blocking the filter vent of the
8 best selling cigarette brand, Marlboro Light."
9 And they found no effect essentially from
10 Marlboro Light. Isn't that true, Doctor?
11 A. They found that when you block the
12 vents of the Marlboro Light, you didn't change
13 the CO, the carbon monoxide jump, in the
14 individuals who used them.
15 Q. Okay. What they say, at least in
16 this chapter which I assume you edited this
17 chapter. Is that right?
18 A. Yes.
19 Q. They say, "This no effect finding
20 for Marlboro Light was subsequently replicated
21 in a second study comparing the effects of
22 finger blocking and not blocking." Correct?
23 A. Yes. But it is a study of the
24 effects of blocking or not blocking on CO.
83
1 Q. Well, you're not being critical of
2 the way Doctor Kozlowski did his studies; are
3 you, Doctor Burns?
4 A. No. I'm trying to define what
5 Doctor Kozlowski actually studied.
6 Q. Okay. And he reported this in the
7 Monograph in the chapter that you edited. Is
8 that right?
9 A. Yes. He reported the effects on
10 CO.
11 Q. Okay.
22 Q. (By Mr. Lombardi) Doctor Burns,
23 you talked about one document in particular at
24 Philip Morris, a study by Barbro Goodman. Is
85
1 that right?
2 A. That's correct.
3 Q. And that was a document from
4 1975. Is that right?
5 A. That's correct.
6 Q. And I think your testimony was
7 that that information should have been made
8 available to you and others in the public health
9 community. Is that right? The information
10 contained in that document?
11 A. I don't believe I testified that
12 it should. I believe I testified that had it
13 been available to us, the conclusions in 1981
14 would likely have been different.
15 Q. Okay. You're not saying that it
16 should have been made available. Is that right?
17 A. My understanding of the word
18 should is that it is a moral judgment or a legal
19 compulsion. It is my recollection of that time
20 that there was no legal compulsion for the
21 tobacco industry to disclose its internal
22 research to the public health community. I
23 would expect, given my own moral values, they
24 should have a moral obligation to do so and
86
1 would have expected them to do so. They
2 certainly offered that as a promise to the
3 American public.
4 Q. Okay. Doctor, I think you said
5 that -- well, strike the question.
6 Are you familiar -- you're familiar
7 with the fact that Doctor Benowitz has testified
8 here in this case?
9 A. I'm familiar that he has
10 testified. Yes.
11 Q. Have you seen his testimony in
12 this case?
13 A. I have not.
14 Q. Have you seen his testimony about
15 the Barbro Goodman document in this case?
16 A. I have not.
17 Q. Are you aware Doctor Farone has
18 testified in this case?
19 A. Yes, I am.
20 Q. Have you seen his testimony about
21 the Barbro Goodman document?
22 A. No, I have not.
23 Q. Are you aware that Barbro Goodman
24 did more studies than just this study that you
87
1 referred to this morning?
2 A. Yes, I am.
3 Q. How many did she do?
4 A. I have no idea.
5 Q. Did you --
6 A. Certainly more than one.
7 Q. Well, how many more than one?
8 Give me a ballpark as best you can. Or if you
9 can't, just tell me.
10 A. There is no way for me to know
11 every study that she has done because I have not
12 seen all of the internal documents from Philip
13 Morris. I would expect that she was a
14 productive -- I believe it's a he.
15 Q. Actually it's a she.
16 A. I've not met her. She was a
17 productive researcher and did many different
18 studies, but I don't know how many.
19 Q. Well, in your desire to come and
20 present to the Court the best information you
21 had about what was going on at Philip Morris,
22 tell the Court the steps you took to make sure
23 you had the body of Barbro Goodman's work.
24 A. I conducted literature searches of
88
1 the various data bases using terms like tar, low
2 tar and a variety of other characteristics,
3 reviewed those and extracted those documents I
4 thought would provide the information that would
5 be useful.
6 Q. How many Barbro Goodman documents,
7 ballpark, did you look at?
8 A. I didn't count them by specific
9 author.
10 Q. Well, I take it that you're not
11 able to relate the results of Barbro Goodman's
12 studies other than the one you talked about
13 earlier this morning as you sit here right now?
14 A. I have seen other works by Doctor
15 Goodman, but I can't tell you the entire body of
16 work from memory. No.
17 Q. Now, you said -- you said that you
18 think the 1981 Surgeon General's Report might
19 have been different had you known about the
20 Barbro Goodman study. Is that right?
21 A. Had I known about the body of
22 evidence reflected by the Barbro Goodman study
23 and others that were consistent with.
24 Q. And you understand that the Barbro
89
1 Goodman studies involved nine smokers. Is that
2 right?
3 A. Yes, I do.
4 Q. Over how many weeks?
5 A. Couple of weeks. I don't remember
6 the exact number.
7 Q. How many cigarettes total did each
8 smoker smoke in those studies or that study I
9 should say, Doctor?
10 A. I would have to look at the study
11 to pull out the number.
12 Q. Was it eighteen?
13 A. I don't know.
14 Q. Okay. Well, but this document --
15 this is a document that you say would have
16 changed the public health world. Is that right?
17 A. No. I said it would be an example
18 of the kind of document and the kind of science
19 that would have changed those conclusions.
20 Q. Okay. But that would change the
21 public health world. That's what you're
22 testifying. Is that right?
23 MR. TILLERY: He just
24 answered it.
90
1 THE COURT: Sustained.
2 Q. (By Mr. Lombardi) Now, you
3 testified in some detail as to how the Surgeon
4 General Reports come to their consensus of
5 views. Is that right?
6 A. Yes, I have.
7 Q. And I tried to take notes on that,
8 but the bottom line is, as important as you
9 were, Doctor Burns, to the process, there were a
10 lot of other people involved as well?
11 A. There most certainly were.
12 Q. There were the individuals that
13 wrote the chapters. Is that right?
14 A. That's correct.
15 Q. They would turn their chapters
16 over to editors. Is that right?
17 A. That's correct.
18 Q. And then the chapters would be
19 sent out to a bunch of reviewers. Is that
20 right?
21 A. That's correct.
22 Q. And then the reviewers would send
23 them back, and the agencies of government would
24 also review it?
91
1 A. That's also correct.
2 Q. All these people -- all these
3 people at the NCI and the Surgeon General's
4 Office, the reviewers, the authors, all of those
5 people make up the consensus that was the 1981
6 Surgeon General's Report. Is that right?
7 A. That's correct.
8 Q. And if we wanted to know -- if we
9 wanted to know what the consensus would have
10 been at that time, those were the people. That
11 was the body of people that we were dealing with
12 that we'd have to deal with to determine the
13 scientific consensus at that time. Is that
14 right?
15 A. I guess I don't understand your
16 question. Those were the body of people who
17 formed the consensus from what has been
18 published at that time that was reflected in the
19 '81 report.
20 Q. Okay. And all of those people --
21 you're not suggesting that you were the only
22 person that made up this scientific consensus?
23 That's my question.
24 A. Absolutely not, no.
92
1 Q. There's a whole body of other
2 people that were involved. Is that right?
3 A. Yes.
4 Q. Now, Doctor, let's go back to
5 Monograph 13. I assume you still have that in
6 front of you. Is that right?
7 A. I do.
8 Q. If you could turn to page
9 seventy-one please, 7109.86 86. Let me know
10 when you've got it, Doctor.
11 A. Almost there. I have it.
12 Q. Okay. And let's highlight the
13 paragraph beginning "However." That's the
14 second full paragraph from the top, Doctor. Do
15 you see that?
16 A. Yes.
17 Q. This is a paragraph that you wrote
18 in the Monograph. Is that right?
19 A. That's correct.
20 Q. And you say, "However, even though
21 the impact of changes in cigarette design on
22 actual smoke delivery to smokers is
23 questionable, early studies of the disease risk
24 among smokers of low yield cigarettes were
93
1 encouraging." And that's true; isn't it?
2 A. That's true.
3 Q. You were encouraged in 1980 and
4 the 1970's by the epidemiological evidence. Is
5 that right?
6 A. Yes, we were.
7 Q. "They demonstrated a somewhat
8 lower lung cancer risk amongst populations of
9 individuals who used filter and low yield
10 cigarettes, albeit a much smaller reduction in
11 lung cancer than the extended reduction in
12 machine measured tar." Is that right?
13 A. That's correct.
14 Q. And that's accurate as well; isn't
15 it?
16 A. That's accurate.
17 Q. "These studies led to considerable
18 optimism about the likely public health benefits
19 of changes that occurred in cigarette design."
20 And that's accurate as well?
21 A. That's correct.
22 Q. And when you refer to U.S.
23 Congress, 1967, are you referring to the Public
24 Health Service Technical Report or something
94
1 else?
2 A. I believe it is the Technical
3 Report as incorporated in the Congressional
4 Record.
5 Q. Okay. The Public Health Service
6 Technical Report was prepared by some scientists
7 like Wynder and others who came to the
8 conclusion that reducing tar would be a good
9 thing essentially. Is that right?
10 A. Yes. That's correct.
11 Q. And you also have a cite to U.S.
12 DHEW. I assume that's Department of HEW. Is
13 that right?
14 A. That's correct.
15 Q. '71 to '79, are those references to
16 Surgeon General Reports?
17 A. They are.
18 Q. And those were Surgeon General
19 Reports that were optimistic about the likely
20 public health benefits of the changes that had
21 been made in cigarette design. Is that right?
22 A. Yes.
23 Q. "The early data were particularly
24 encouraging because the reductions in lung
95
1 cancer risks were demonstrable in populations
2 observed during the mid to late 1960's when
3 filter cigarettes had only been available for a
4 short period of time." Is that right?
5 A. That's correct.
6 Q. You cite some -- is it Bross or
7 Broad, Doctor?
8 A. Bross I believe. I don't know
9 him.
10 Q. Okay. But that's one of the
11 studies that you cite in your Table 4.1 that
12 goes through all of the epidemiology. Is that
13 right?
14 A. It is.
15 Q. "Wide spread use of filter and
16 lower yield products began in the mid fifties.
17 Since the reduction in excess lung cancer risk
18 with cessation continues to increase for fifteen
19 to twenty years following cessation" -- couple
20 of citations -- "It was expected that these
21 modest changes in risk demonstrable with
22 short-term use of reduced tar products would
23 have a growing impact on lung cancer death rates
24 as more smokers use these products for longer
96
1 periods of time." Right?
2 A. That was the expectation.
3 Q. Okay. And that is what you
4 believed in good faith during that period of
5 time. Is that right?
6 A. No. That's what we hoped for in
7 good faith at that period of time.
8 Q. That's what you expected to have
9 happen. Is that right?
10 A. That is correct.
11 Q. Okay. Next paragraph, "Over the
12 last fifty years" at the bottom there.
13 "Over the last fifty years, machine
14 measured sales weighted tar yields for U.S.
15 cigarettes have declined by over sixty
16 percent." You were referring to what has
17 happened to machine measured tar yields of
18 things like light cigarettes and so forth. Is
19 that right?
20 A. For all cigarettes on the U.S.
21 market as a whole but driven by --
22 Q. Driven by lower tar yield
23 cigarettes bringing it down?
24 A. It was driven by changes within
97
1 brands. It was driven by the introduction of
2 new brands.
3 Q. Then you say, "Several careful
4 reviews of the available scientific data." And
5 you have two citations. The one that says DHHS,
6 1981. That is the 1981 Surgeon General's
7 Report. Is that right?
8 A. Yes, it is.
9 Q. And that was the careful review of
10 the then available scientific data. Is that
11 right?
12 A. Yes, it was.
13 Q. And NCI, 1996, that's referring to
14 Monograph Number Seven. Is that right?
15 A. That is correct.
16 Q. And that was another careful
17 review of the scientific data that was available
18 at that time?
19 A. Yes. As of 1994.
20 Q. Right. The conference was in '94,
21 and the publication came out in '96. Is that
22 right?
23 A. That's correct.
24 Q. And those two which were what,
98
1 about fifteen years apart? "Have suggested that
2 there is a reduction in lung cancer risk for
3 populations of smokers who use lower yield
4 cigarettes if they did not increase the number
5 of cigarettes that they smoked as they decreased
6 the yield of the cigarette that they smoked."
7 Correct, Doctor?
8 A. Yes. They both articulated the
9 same expectation we had felt in the preceding
10 paragraph.
11 Q. And the 1996 careful review in
12 Monograph Number Seven was the one that, as best
13 you can tell, was done in good faith. Is that
14 right?
15 A. Yes. It was done by Don Shopland.
16 Q. Using the best scientific evidence
17 available at that time. Is that right?
18 A. That's correct.
19 Q. And the conclusions that they drew
20 from that were the best conclusions that they
21 could draw given the state of knowledge at that
22 time. Is that right?
23 A. That's correct.
24 Q. Okay. Now, Doctor, just --
99
1 MR. LOMBARDI: What do I
2 have, Your Honor?
3 THE COURT: Three minutes.
4 Three minutes.
5 Q. (By Mr. Lombardi) Okay. Table
6 4.1, Doctor, I think is on page eighty-two if
7 you can find that.
8 A. I have it.
9 Q. Okay. This is a list of
10 epidemiology studies from the late sixties up
11 through the nineties that you looked as part of
12 the Monograph. Is that right?
13 A. That's correct.
14 Q. And these studies were -- the way
15 an epidemiology study is done -- I'm going to be
16 very basic, Doctor, because I know it's more
17 complicated than this. But the basic idea, you
18 have a population. You learn about the
19 characteristics of that population, and you
20 track what diseases the population gets. Is
21 that, in a very general sense, what happens?
22 A. A very general sense, yes.
23 Q. Okay. And Table 4.1 these
24 epidemiological studies were done in that way --
100
1 in that general way. Is that right, Doctor?
2 A. They were done in a variety of
3 different ways. Some were cross-sectional.
4 Some were retrospective which is a different
5 way. You look at people with disease and look
6 backwards in time to see what their
7 characteristics were.
8 Q. Fair enough, Doctor. All I'm
9 getting at here is what this involves is -- all
10 of these studies involve scientists looking at a
11 population of people and drawing conclusions
12 about that population of people. Is that right?
13 A. Well, no. It also involves
14 studies designed where they look at two
15 populations of people and compare the two.
16 Q. Okay. Okay. But they're dealing
17 with populations of people. Is that right?
18 A. That's correct.
19 Q. They're not dealing with tobacco
20 company documents. Is that right?
21 A. That's absolutely correct.
22 Q. And, Doctor, one last question.
23 There is a problem -- a difficulty, I should
24 say, with epidemiology when you have a latency
101
1 period. Is that right?
2 Let me reframe it. I can see it was a
3 confusing question.
4 You understand there is a latency
5 period for lung cancer. Is that right?
6 A. That's correct.
7 Q. What is it? Twenty to thirty
8 years?
9 A. Depending on how you use the term
10 latency period, there is approximately a twenty
11 year period from onset of cigarette smoking to
12 onset of death from lung cancer due to lung
13 cancer caused by cigarette smoking. But the
14 latency is also used on an individual basis as
15 the time from starting the exposure to the time
16 the individual developed lung cancer.
17 Q. Okay. And so the latency period
18 means that there are inherently, when you study
19 cigarette smoking and lung cancer, going to be
20 delays before you can see the effects of a
21 particular product or design change. Is that
22 right?
23 A. I think that's not correct.
24 That's a different concept that you're using.
102
1 It is true that when you change, for example
2 when you quit, it takes time for the risk to
3 diverge from those who have not changed as in
4 cessation. But it is not true the way you've
5 expressed it. You've over simplified it.
6 Q. Okay. Well, when did low tar
7 cigarettes become the dominant cigarettes on the
8 market?
9 A. Filter cigarettes became the
10 dominant cigarettes on the market in the
11 1950's. And depending on your definition of low
12 tar, it became the dominant cigarette by the
13 seventies.
14 Q. Late seventies? Whatever you
15 know, Doctor?
16 A. Early seventies depending on the
17 definition you use.
18 Q. Okay. So we have to -- if we want
19 to find out the effect of the epidemiological
20 effect of cigarettes that first came out in the
21 1970's, we have to work in that latency period.
22 Don't we, Doctor?
23 A. No. We don't. What you do is
24 work in the period of time before being able to
103
1 distinguish the effect of cessation which is
2 about five to ten years as opposed to a twenty
3 year latency period.
4 Q. Doctor, you would agree that for
5 people who started smoking light cigarettes,
6 there is not enough information available right
7 now to come to a conclusion on the
8 epidemiology. Is that right?
9 A. There is not enough evidence to
10 draw conclusions based on epidemiologic risk of
11 lung cancer on those individuals who have been
12 smoking currently for less than twenty years.
13 Q. And does that mean, Doctor, that
14 there is not -- the cancer risk for individuals
15 who have only used low and ultra low cigarettes
16 have yet to be fully described?
17 A. They have yet to be fully
18 described. There is no expectation, from what
19 we understand, that they would be different.
20 But you are accurate in that they have yet to be
21 described.
22 MR. LOMBARDI: Thank you,
23 Doctor.
24 THE COURT: Redirect.
104
1 REDIRECT EXAMINATION
2 Questions By Mr. Zelcs:
3 Q. You were asked a series of
4 questions about your prior work in asbestos
5 litigation?
6 A. That's correct.
7 Q. You testified that you had been an
8 expert witness on behalf of the defendant. Is
9 that correct?
10 A. That's correct.
11 Q. Have you also testified on behalf
12 of plaintiffs in asbestos litigation?
13 A. Yes, I have.
14 Q. Even when testifying on behalf of
15 defendants, did you, on occasion, find that
16 certain plaintiffs were sick as a result of
17 asbestos exposure?
18 A. Yes. As a matter of fact, most
19 commonly I found that the individuals were sick
20 with some form of asbestos or asbestos-related
21 injury.
22 Q. In your own practice, you've
23 treated patients suffering from asbestos-related
24 disease as well?
105
1 A. Yes. I certainly have.
2 Q. Have you also treated on a regular
3 basis patients in the past suffering from
4 smoking-related diseases?
5 A. That's correct.
6 Q. You were also asked about
7 compensation that you have received as a result
8 of serving as an expert witness in litigation.
9 How much have you been paid in this case?
10 A. Six thousand dollars.
11 Q. You were also asked about a letter
12 in October of 2002 to Mr. Pahl at the FTC. And
13 there was a reference to the other signatores of
14 that letter, Mr. Benowitz -- I'm sorry -- Doctor
15 Thun, Doctor Benowitz, Doctor Kozlowski, Doctor
16 Giovino, Doctor Hatsukami. Did I get that
17 right?
18 A. Yes.
19 Q. Doctor Henningfield. Would you
20 consider all of these people to be well known
21 members of the scientific community?
22 A. Yes. I certainly would.
23 Q. And you authored this letter. Is
24 that correct?
106
1 A. I authored the initial draft, and
2 each of them I believe made some suggested
3 changes.
4 MR. ZELCS: Your Honor, I
5 would like to move this letter and mark it as
6 Exhibit 62 into evidence.
7 MR. LOMBARDI: No objection,
8 Your Honor.
9 THE COURT: Admitted.
10 Q. (By Mr. Zelcs) Has the FTC taken
11 any official action since publication of
12 Monograph 13 as to the use of the word light in
13 cigarettes?
14 A. No.
15 Q. Has the FTC ever required Philip
16 Morris to use the word lower tar and nicotine in
17 describing Marlboro Lights?
107
1 Q. (By Mr. Zelcs) Has the Federal
2 Trade Commission ever required Philip Morris to
3 use the descripter light in the name of its
4 Marlboro Light and Cambridge Light cigarettes?
5 A. No, it is has not.
9 Q. (By Mr. Zelcs) Let me ask you that
10 question again. Has the FTC ever required
11 Philip Morris to use the words lowered tar and
12 nicotine in the description of Marlboro Lights?
13 A. No, it has not.
14 Q. Has the FTC ever promulgated any
15 specific regulations or guidelines as to the
16 description of light?
17 A. No.
18 Q. You were also asked a bunch of
19 questions regarding these e-mails and other
20 communications with Doctor Thun, Doctor Peto,
21 Doctor Tarone and Doctor Lubin. Spent a lot of
22 time on that. Looked at a lot of stuff there.
23 Doctors Lubin and Tarone, who are they
24 with?
108
1 A. They both are within the
2 epidemiology group at the National Cancer
3 Institute.
4 Q. And the National Cancer Institute
5 is the entity that approved and okayed the
6 issuance of Monograph 13 in its final form. Is
7 that right?
8 A. Yes. That's correct. And that
9 groups specifically signed off in agreement with
10 the conclusions of the Monograph.
11 Q. And all of those e-mail
12 communications and other things that Mr.
13 Lombardi wanted to spend a lot of time on, those
14 were all things that were in the middle of the
15 process?
16 A. Yes.
17 Q. Those weren't generated after the
18 final conclusions in Monograph 13 and the
19 various chapters were prepared. Correct?
20 A. That's absolutely correct. They
21 were all part of the process of improving the
22 quality of the document that we were bringing
23 forward to be the final document.
24 Q. And that give and take between the
109
1 reviewers and yourself, that wasn't the first
2 time you had ever seen that sort of activity as
3 part of your work in either the Monograph or the
4 Surgeon General's Report. Correct?
5 A. No. As a matter of fact, it is
6 the norm particularly when you have an area that
7 is evocative.
8 Q. That's what makes this process
9 robust and rigorous. Correct?
10 A. That is what peer review is.
11 That's the hole point of peer review. It's not
12 to have somebody say yes or no. It's to get
13 input from different perspectives that improves
14 the quality of the final product.
15 Q. You don't want reviewers that are
16 yes men or blow kisses your way; do you?
17 A. No.
18 MR. LOMBARDI: Object to the
19 form, leading.
20 THE COURT: Yeah.
21 Sustained.
22 Q. (By Mr. Zelcs) In response to the
23 various comments and communications between
24 these reviewers and yourself, there were changes
110
1 that were made to the draft that existed at that
2 point in time in Monograph 13 and the various
3 chapters. Correct?
4 A. Yes. The Monograph was
5 extensively modified after the last of those
6 e-mails that was presented here today.
7 Q. And there were numerous revisions
8 that were made in response to the comments that
9 you were asked about?
10 A. There were almost innumerable
11 revisions of the document over the three year
12 process that was it was in production.
13 Q. And after all of this discussion,
14 this drafting, this revising, this review, this
15 conferencing, this meeting, all of that,
16 Monograph 13 was published. Right?
17 A. After that was all done, the
18 conclusions were written and the agreement was
19 on those specific conclusions. And then it was
20 published.
21 Q. And that process, every bit of it,
22 that's why you can say this is a consensus
23 document. Is that right?
24 A. Yes. That's absolutely correct.
111
1 Q. Let me see if I -- maybe I
2 misunderstood something. Was it you that called
3 the FTC and asked them to do a Monograph?
4 A. No.
5 Q. How did that work? Was it the
6 other way around?
7 A. The FTC called the Food and Drug
8 Administration and the NCI and asked them to do
9 a review, and we did that as a Monograph.
10 Q. Did I misunderstand? Were you the
11 guy that determined what the subject matter of
12 Monograph 13 would be?
13 A. No. I wasn't.
14 Q. How did that happen?
15 A. That was the FTC asked the NCI to
16 address a specific question. The specific
17 question was whether there was a reduction in
18 disease risks for the use of low tar and
19 nicotine cigarettes.
20 Q. Maybe I misunderstood this as
21 well. Did you choose yourself to be the head or
22 the scientific editor for Monograph 13?
23 A. No. I was chosen.
24 Q. How did that happen?
112
1 A. I was chosen by the FDA and the
2 FTC.
3 Q. At the outset, think back of Mr.
4 Lombardi's examination. He was asking you a lot
5 of stuff about well what about the U.S. and all
6 of that. Do you consider Monograph 13 to
7 represent the United States government's
8 position on this issue?
9 A. Yes, I do.
10 Q. The 2000 Surgeon General's Report,
11 you didn't author any chapters in that. Right?
12 A. I did not.
13 Q. You were a reviewer?
14 A. I was a reviewer.
15 Q. If I were to tell you that there
16 was seven pages of people's names listed on that
17 as participating in the Surgeon General's
18 Report, would that surprise you?
19 A. No.
20 Q. And who were these people that
21 participated in that Surgeon General's Report?
22 A. They were scientists all across
23 the United States who had been studying various
24 aspects of tobacco and tobacco related disease
113
1 and smoking control.
2 Q. These people are all well known,
3 all well respected in the scientific community?
4 A. Yes, they are.
5 Q. And the statements that Mr.
6 Lombardi read to you, did they represent the
7 consensus of opinion of those people that
8 participated in that Surgeon General's Report?
9 A. The conclusions certainly would,
10 but I don't recall the specific statements.
11 Q. If Doctor Peto is correct that
12 lung cancer mortality for men in middle age is
13 larger and can be explained by prevalence in
14 smoking, does that mean that any increase in
15 risk can be attributable for Marlboro Lights or
16 Cambridge Lights cigarettes?
17 A. Well, the answer to your question
18 is two parts. First, he is, indeed, correct.
19 That observation is factually accurate. However,
20 the explanation for that observation is not
21 limited to a decline in risk of low tar and
22 nicotine cigarettes. There was ample
23 opportunity to explain that with changes and
24 initiation, with intensity of smoking at early
114
1 ages as well as with increased cessation.
2 Q. Chapter Four, was it modified in
3 part at all based upon Peto's input?
4 A. Absolutely. There was an
5 extensive modification where we included a whole
6 section and examined the changes in lung cancer
7 death rates in the UK and the United States in
8 relation to what was known about their smoking
9 behaviors. And we added a whole eight or ten or
10 more pages to that.
11 Q. You were also asked some questions
12 about the '81 Surgeon General's Report.
13 A. Yes.
14 Q. There was some discussion about
15 whether that included the best scientific
16 evidence as published to date?
17 A. That's correct.
18 Q. Studies like the Barbro Goodman
19 study, if they weren't published, they couldn't
20 be considered for inclusion in a document like
21 that; could they?
22 A. That's absolutely correct.
23 Q. I have no further questions for
24 you. Thank you, sir.