**---------------------------------------------------------
DIRECT EXAMINATION - DR. RICHARD HURT STATE OF MINNESOTA
DISTRICT COURT COUNTY OF RAMSEY
SECOND JUDICIAL DISTRICT
File No. C1-94-8565
The State of Minnesota, by Hubert H. Humphrey, III, its attorney general, and Blue Cross and Blue Shield of Minnesota,
Plaintiffs,
vs.
Philip Morris Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson Tobacco Corporation, B.A.T. Industries P.L.C., Lorillard Tobacco Company, The American Tobacco Company, Liggett Group, Inc., The Council for Tobacco Research-U.S.A., Inc., and The Tobacco Institute, Inc.,
Defendants.
TRANSCRIPT OF PROCEEDINGS
VOLUME 7, PAGES 1169 - 1362
JANUARY 28, 1998
DIRECT EXAMINATION - DR. RICHARD HURT P R O C E E D I N G S.
THE CLERK: All rise. Ramsey County District Court is now in session, the Honorable Kenneth
J. Fitzpatrick now presiding.
Please be seated.
THE COURT: Good morning.
(Collective "Good morning." )
THE COURT: We have a motion to admit pro hac vice Marie V. Santacroce. Is she here?
MS. SANTACROCE: Yes, Your Honor.
THE COURT: Welcome to Minnesota. And the motion is granted.
Mr. Ciresi.
MR. CIRESI: Yes, Your Honor.
Your Honor, yesterday Mr. Bernick in his opening statement made the following statements: "Did we use private facts for this discussion in our positions, or were we relying on the same public facts that everybody else has made available to them through the offices of the scientific community and the Surgeon General? Our position is that our views and our conduct was driven by public facts that our customers, that the states and others can appreciate just along with us." Page 1117 of the transcript.
Again at page 1118, "How do we reconcile what we said in our positions with our responsibilities to our customers to share information with them? We relied upon the fact -- and it will be a fact -- that we're dealing with a public discussion and public facts. We expected our customers to do what everybody else and the public did, which is to see what the public facts were, the public decisions were, and the debate, and to make their own decisions about what opinions to hold. It comes down to making a choice based on publicly available information."
We believe that that is a representative admission by Mr. Bernick on behalf of all of the defendants that they did not disclose their private information which was in their files, and that the jury should be so instructed that the defendants have not disclosed private information with regard to the undertaking that they undertook in 1954.
MR. BERNICK: Your Honor, Mr. Ciresi I don't think began at the beginning of that portion of the argument and he's taken those statements out of context. I stand by the statements that were made, but what I was describing to the jury -- the first part of the opening statement explored in detail the fact that the information that Mr. Ciresi showed from our files on opening and characterized as being private information, known to nobody else, that those representations were wrong because the same theories, the same basic principles that are in our documents were in the open scientific literature, indeed in large part they came to us from the open scientific literature. That's -- that's an argument that we made, we stand by, and the jury can assess at the conclusion of the case after they hear the evidence.
I then went on to talk about what our defense of smoking had been, that was the very last segment, and I described to the jury the positions that we had taken publicly as part of our public defense of our position, and the message was very, very simple, which is when it comes to causation or it comes to addiction, we erected our position on the basis of those public facts because the debate was in fact a public debate. Essentially, we participated in it.
There was no representation, there was no admission that there were private facts that were in some fashion material that we had failed to disclose. All that I was saying, and I think it was clear to the jury, was that we jumped into that public debate and we participated in it like anybody else, and our responsibilities to our consumers were discharged in the same fashion that they would be under the same circumstances, which is consumers, cognizant of that same public debate, could form their own opinion. I think it's a perfectly straightforward argument, it's an important part of the case, and there's absolutely no admission involved in that. The jury can draw their own conclusions, Your Honor.
THE COURT: Well what may have been clear to the jury is not exactly clear to the court. In reading the transcript, it does appear that -- I'd have to go back and read the entire transcript, I guess, but from these statements, is it correct that you are not relying solely on what was publicly available?
MR. BERNICK: For purposes of the positions that we announced on causation and addiction, we were relying upon -- we were reciting the same public facts that were available to everybody; for example, mechanism for causation of cancer has not been established, that's something that we can show from the scientific literature. The failure to replicate human-type lung cancer in significant numbers and consistently, that's in the Surgeon General's report in 1982. Those are the kinds of facts, Your Honor, that we relied upon and still do rely upon in our articulating our position on causation.
THE COURT: Exclusively?
MR. BERNICK: I would suppose for purposes of our public positions we would rely upon public facts, yes.
We don't believe that there's anything that's inconsistent with that that we have in our own files, but all that I was saying is that when it comes to a public debate in Washington, we're jumping in and using the same facts everybody else does. They're not -- they're not unknown facts, they're known to everybody.
It's really a different -- it's a very different issue, Your Honor, from the issue whether there was something that was in our files that nobody else knew. That's what I stressed in the opening part -- in the bulk of my opening statements. Was there some secret that we had? And -- and we'll say that we didn't have a secret. There was no silver bullet that we had discovered internally that we failed to share with people, and they won't be able to show it either.
THE COURT: But the issue is -- is not the issue whether or not you agreed to do independent research to examine the hazards of smoking?
MR. BERNICK: Yes, there's an independent issue whether we agreed to do the research. The front part of my opening statement I said we did agree to do the research, and it's right in the Frank Statement, and we went ahead and satisfied that promise and satisfied that obligation.
THE COURT: And are you relying on that research?
MR. BERNICK: We're relying --
Research that we agreed to do in the Frank Statement was the CTR grant program. We are relying upon that research, Your Honor, in saying that we discharged the obligation of the Frank Statement.
Again, we said the Frank Statement was there, the Frank Statement said that we'd set up a research organization and we would fund it and we would make the research available. That's exactly what the CTR grant program was. We did it. We made the research available. We are relying upon that public research in saying we discharged the obligation that was assumed in the Frank Statement. That's absolutely correct.
Now there's other research that we did, Your Honor, that was research that was commercial research, research that was directed to changing our product. Some of that research was published, some of it was not because it might not be of publishable quality or it might be proprietary. That's a totally different ball of wax. That's research that we used commercially to change our product. Got Ames test, inhalation tests. All companies do commercial research.
We never undertook, if this is the force of Your Honor's question, which I would like very much to respond to, we never undertook to make available to the public every piece of research data that we ever produced internally. We have made no such commitment. We do not construe the Frank Statement in that fashion.
I didn't argue to the jury that the Frank Statement undertook that obligation. The Frank Statement was a -- is a commitment to create a certain research program through outside scientists. That was done. Commercially we engaged in other research. That research also was done. But we don't sit there and, every time we finish a commercial research project, turn it over to, you know, the Surgeon General or to the New York Times. That's not how companies do business.
I'm trying to be responsive to Your Honor's question. I'm not sure if I have been.
THE COURT: Okay. My concern is -- and I understand what you're saying, that you didn't agree internally to do everything, but on the other hand you are saying here that you relied on none of your private research in taking a position. That's what I'm concerned about.
MR. BERNICK: Okay. Well let me rectify that.
THE COURT: All right.
MR. BERNICK: There's been a lot of discussion about the public positions we've taken and all the guys standing up under oath and saying I don't think nicotine is addictive or people saying causation has not been established. Those are public positions. When we're asked for our views, we state a public view.
What I told the jury was when it comes to a position like causation, that's a position which we have articulated and which we rely upon public facts. We don't rely upon our commercial research to take a position on whether cigarettes cause disease. The two things don't have much to do with one another. We rely on the public research that's published in peer review journals or in the Surgeon General's report, as an example. What happened in the laboratory experiments, that's a publicly stated fact; it is one of the pillars of our public position on causation. Same thing with regard to addiction. You're talking in the world of what we say about causation and addiction, Your Honor, about matters that have great importance for regulatory purposes, for legislative purposes, for litigation purposes. Those are statements that are made in the public arena.
We, in creating those positions, used the same facts as everybody else did. It's just a very -- it's like you were thinking about, what is it that you would say to a regulator? We say, well, we'll work with the same information everybody else has. This is our position. That's what I was telling the jury.
THE COURT: I'll take the matter under advisement.
MR. CIRESI: Your Honor, may I just address two things?
THE COURT: I don't want to spend the morning on this.
MR. CIRESI: And I don't either.
THE COURT: Okay.
MR. CIRESI: First of all, when they referred to the Frank Statement, they also said as follows, "The joint financial aid will, of course, be in addition to what is already being contributed by individual companies."
Now, Mr. Bernick's position is very simple. Whatever is in the public, we will take a position based only on that information. Now let's just think about that for a minute. If that is the legal duty -- and this is a legal issue -- then I as a manufacturer can have within my files a plethora of information regarding the dangers and hazards which contradicts, supplements, changes or modifies what is in the public domain, and I don't have to say anything. I'll just take a public position based on what's out there. Totally contrary to the law and totally contrary to the undertaking that they took in the Frank Statement, because they divided -- they talk about the Scientific Advisory Board of the TIRC, actually they talked about TIRC, and they talk about the fact that they are doing research in addition to that in the individual companies. All of that has to be disclosed. That's absolutely essential. And it is contrary to the law to say that I can sit back and -- let me quote Mr. Bernick -- "Listen to our positions carefully. They were carefully crafted."
Yes, they were carefully crafted. And this is their position: We're only doing what's in the public, and anything that's in our files has nothing to do with positions we took. That's simply contrary to the law, and we believe we're entitled to an instruction on that.
MR. BERNICK: If we made representations to the public which are in fact contradicted by what's in our own files, Mr. Ciresi can prove it up to the jury. The whole force of my opening statement for an hour and a half was that he won't be able to do it. That's the issue for the jury to resolve. I'm not saying we can sit there and make public statements with impunity for what's in our files. If in fact we have material information in our files and people should have known, we failed to disclose it, we issued contrary public statements and he can prove it up, the jury will be convinced and they can find against us, if there's any evidence that had any impact on people who are plaintiffs here. He won't be able to do that. But it has nothing to do --
What I made was a very simple statement to the jury. We participated in the public debate using the same materials as everybody else did. That's not an admission that somehow we should have disclosed more.
If he thinks that we should have, that's exactly what he can pursue.
And with regard to the Frank Statement, that's in addition to what's already being contributed. Some of the companies already were funding outside research with independent scientists; for example, at the Medical College of Virginia. And that continued. That's not a statement that somehow all of a sudden by making the Frank Statement, we now open the door to all of our proprietary research and say anybody can come in and take a look at what we're doing with our product. That way we couldn't conduct business.
These are all issues of fact, Your Honor, for the jury to resolve. I think we were straight with the jury. If we weren't straight with the jury, they're going -- they're going to let us know that in their verdict. But these are matters for the jury to resolve.
THE COURT: Well --
MR. BERNICK: I'm not making any arguments about Mr. Ciresi's opening statement. We could have a long discussion about what he led the jury to believe in his opening statement.
THE COURT: All right. Let's see how it works out. But I am concerned. Maybe I don't understand what you said and maybe the jury does, but I am somewhat concerned. And as the case unfolds, if in fact the defendants do take the position that their private research is not relevant to their public positions, then you probably will find my instructing the jury to the contrary. So you may want to keep that in mind.
Why don't we move on, huh? Okay. Bring the jury in.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Good morning, members of the jury.
(Collective "Good morning." )
THE COURT: Mr. Ciresi.
MR. CIRESI: Thank you, Your Honor. The plaintiffs called Dr. Richard
D. Hurt to the stand. Doctor.
THE CLERK: Please remain standing and raise your right hand.
(Witness sworn.)
THE CLERK: Please state your name for the record.
THE WITNESS: Richard
D. Hurt.
THE CLERK: Thank you. Please have a seat.
RICHARD D. HURT called as a witness, being first duly sworn, was examined and testified as follows:
DIRECT EXAMINATION BY MR. CIRESI:
Q. Good morning, doctor.
A. Good morning.
Q. Let me start out with a little personal information for the jury so they have an understanding of where you came from and -- and what you do in your profession.
Can you tell us where you live, sir?
A. I live in Rochester, Minnesota.
Q. Are you married?
A. I am.
Q. Any children?
A. I have three children and two grandchildren, one just a week and a half old.
Q. All right. Can you tell us what your present employment is?
A. I'm a consultant in internal medicine and director of the Nicotine Dependence Center at the Mayo Clinic.
Q. Doctor, can you maybe get that mike up a little bit and make sure everybody --
Is everybody able to hear?
A. Is that okay? Is that better?
Q. How long have you been at the Mayo Clinic?
A. I came there in 1973, so 28 -- 26 years I guess, almost 26 years.
Q. And you're a professor of medicine at the Mayo Medical School?
A. That's correct.
Q. Okay. And you consult on internal medicine at the present time?
A. That's right. That's the title, is consultant. It's really a staff member of the Mayo Clinic, is the better -- better title to use.
Q. Can you describe what your duties and responsibility are in that regard, doctor?
A. I'm a primary-care internist. I see patients every day. A primary-care internist is like a family physician, although I'm an internal medical physician. I see adults, no pediatrics and no obstetrics. So that's kind of one side of my job is to see patients on a regular basis.
Q. Okay. And where were you born, sir?
A. In Murray, Kentucky.
Q. And where did you obtain your undergraduate degree?
A. Right -- right at home Murray State University of Murray, Kentucky.
Q. Was that in 1966?
A. That is correct.
Q. Okay. And where did you obtain your M.D. degree?
A. From the University of Louisville in Louisville, Kentucky.
Q. After obtaining your degree did you have an internship?
A. I did. I went to the Baptist Hospital in Memphis, Tennessee, and did my internship there in internal medicine.
Q. After you completed your internship at Baptist Memorial, what did you do?
A. I got drafted and I was in the Army for two years. And then after that I -- I came to Mayo Clinic to do my fellowship.
Q. So you were in the Army from 1971 to '73?
A. That's correct.
Q. Now the fellowship at the Mayo Clinic between 1973 and 1976, can you describe that, please?
A. Well a fellowship in internal medicine, we go through rotations, various subjects in internal medicine like hematology and cardiology and those sorts of things. At that time we had a required rotation in psychiatry, and that's where part of my interest in this whole area came from. My first rotation was on the addictions unit at Mayo Clinic, at the time when addictions units were very uncommon, in fact it was just opened a year and a half or so before I did my first rotation.
So in the fellowship you rotate through various stages of -- of medicine or various topics in medicine like those, so in those three years I rotated through probably ten or 12 of the areas of internal medicine.
Q. And in 1988 you became in charge of the Nicotine Dependence Center?
A. That's correct. That was after a two-year planning effort to develop this program, which was started in April of 1988.
Q. Can you tell us what the Nicotine Dependence Center is at the Mayo Clinic?
A. It is a program that's based on all that we can learn and know about the treatment of patients with nicotine dependence. It's solely devoted to that. It's modeled after an addictions model which obviously came from all the things that I'd learned from before, and the counselors are trained -- the counselors are the ones who provide most of the services, although I oversee that along with other physicians who work in the Nicotine Dependence Center -- the counselors provide services to the patients what are for the most part referred by Mayo physicians, but some are self-referred. About 85 percent of the patients are referred by Mayo physicians who may be concerned about the patient, may be concerned about their heart disease or their lung disease and want them to try to stop smoking, and the other 15 percent or so are referred by themselves. They call up and make an appointment to see one of the counselors.
The counselors are master's level people who have training in what we consider to be kind of the pillars of this program, which is behavioral treatment, addictions treatment, pharmacologic treatment, and prevention of relapse. Those are kind of the four hallmarks or the pillars of this program.
Q. And how many patients have been through the dependence center since 1988, doctor?
A. Since April of 1988 they have seen 15,313. That was as of December of 1997.
Q. In addition to patient services, is there research and education conducted at the Nicotine Dependence Center?
A. Correct. And the Mayo logo, which we all really try to adhere is a best we can, has three parts to it, it's three interlocking shields, and the middle one is patient services. We really focus on patient care, that's our focus in the entire institution, but it's really also the focus within the Nicotine Dependence Center. So the center of our activities has to do with the patient, what's in the best interests of the patient is in our own best interest.
The other two interlocking shields are research and education. We view this as an integrated practice of those three things, that's what makes Mayo Clinic really special because we have those three things operational all the time in all the things that we do.
The analogy is a tricycle. A tricycle has three wheels. The big wheel in the front is the driving force behind the tricycle, but the tricycle obviously will not roll unless all three wheels are present. So the big wheel in the front is patient services, and the two wheels in the back are education and research. And one of our goals at the very beginning of this was to establish the program so that it had all three of those things almost from the very beginning. So we opened up our clinical program in April of 1988 and did our first nicotine patch study in September of the same year and began having our first medical students and residents rotate through the Nicotine Dependence Center within the first year.
So it was the -- it's the integration of those three elements that really make what we do there very special.
Q. Doctor, I'd like to go over some of your -- your qualifications and background, some of the organizations that you belong to and have belonged to during the course of your career. You've been a member of the District Chemical Abuse Advisory Committee?
A. Correct.
Q. You've been a member of the Mayor's Advisory Committee on Alcohol and Drug Abuse and also served as chair of that committee at one time?
A. That's been a while ago, but I did that.
Q. Okay. And you've also served for the Smoke Free Generation Minnesota vice chair and board of directors?
A. Correct.
Q. You've also been on the Rochester Foundation for Educational Excellence?
A. That's correct.
Q. You've also been a member of the American Foundation -- I'm sorry, American Society of Addiction Medicine Committee on Nicotine Dependence?
A. And that's really our national organization that has to do with addiction medicine. It's a national organization made up of 3,500 or 4,000 physicians from around the country. That's -- that's really kind of the -- the main focus of our national activities.
Q. And you serve as chair of that organization?
A. I serve as chair of the conference committee. They've put on a conference and have put on 11 or 10 conferences now on nicotine dependence. The first one was here ten years ago and the 10th one was here just this last year.
Q. You've also served on the board of advisors of the Indiana University Nicotine Dependence Center from 1992 to the present time?
A. Correct.
Q. You've also been a special consultant to the Ministry of Health in Singapore?
A. Correct.
Q. And you've been a special consultant to the -- and I know I'm going to torture this word -- Bekhterev --
A. Bekhterev, yeah.
Q. -- Psychiatric Institute in St. Petersburg, Russia?
A. Right. That was a humanitarian aid commission that I did through AmeriCares, going there to teach them about nicotine dependence and teaching them how to learn -- or teaching them about using nicotine patch therapy, which they had not had up until that time.
Q. You've also served on the Society of the Research on Nicotine and Tobacco?
A. Correct.
Q. And you've been a member of the AMA Adolescent Smoking Cessation Advisory Board from 1995 to the present time?
A. Yes.
Q. You've also been a member of AmeriCares Medical Advisory Board from 1995 to the present time?
A. Correct.
Q. You're also a member of the American College of Physicians and hold a fellowship position there?
A. Uh-huh.
Q. And you're member of the American Society of Addiction Medicine.
A. Correct.
Q. Okay. Now you've also published a number of articles in peer-review journals; is that correct, doctor?
A. That's right, yes.
Q. And I think it's in excess of 60 articles in peer-review journals, plus also chapters in books?
A. Correct.
Q. Okay. I'd like to go over just a few of those with you so the jury gets an understanding of the nature of the work that you've done in this area.
You published in the Mayo Clinic's Proceedings an article entitled "Long-term Follow-up of Persons Attending a Community-Based Smoking Cessation Program;" is that correct?
A. That's correct.
Q. You can you describe that article just briefly?
A. In the mid-1970s there were very few treatment facilities available for patients or for even people from the community, and there was a -- a community effort called The Smokers Clinic which was run three times a year, available at Rochester Methodist Hospital, and it was a program that was run over an eighth-week period of time, and one session each week for those eight weeks. And this study he's mentioning is the outcome from that. We looked back at the people that had been part of that study over time and then determined what -- how well they did as far as how well they were able to stop smoking as a result of that. That's one of the first -- first ones that we did as far as doing smoking outcomes.
Q. Another article you published was in what's called JAMA, or the Journal of the American Medical Association, in 1989, "The Making of a Smoke-Free Medical Center?"
A. Correct.
Q. Can you describe that one, please.
A. Well in the mid-'80s there was a move afoot within the medical communities around the country to develop a smoke-free indoor-air policy. We had patients who were concerned about inhaling other people's smoke because they would be in the hospital and within the clinic, they might have lung disease or heart disease, so it became an issue that -- that the institution, the Mayo Clinic, decided to implement a smoke-free policy throughout the buildings, on the grounds and so on, and this was an article that -- that really described the process. We were probably the second medical center of any size to do this, and this described the process. And other people around the country then used that process on how to go about doing this to implement it in other -- other -- other institutions. And eventually that became a national policy that's been mandated by the JCHO for all hospitals within -- within the country.
Q. What was that acronym you just used?
A. JCHO, the Joint Commission on Health-Care Organizations. It's the accrediting body. They come in and determine whether or not your hospital is clean, safe, and all the procedures are being done. So it's the thing that gives accreditation for hospitals. So that's a requirement from that organization for all hospitals throughout the country now.
Q. Another article that you published was entitled "The Inhalation Treatment of Severe Nicotine Dependence," and that was published in the Mayo clinical Proceedings Journal. Can you describe that one briefly?
A. Well when we were approved to start our nicotine dependence program, we proposed actually to have several different levels of intervention or levels of treatment. We knew that people with more severe nicotine dependence would need more intervention. We didn't know exactly at that time what kind of intervention they might need, and so when we -- we got approval from the institution to -- to start this program, they recommended that we -- before we go to more intensive interventions, that we do a research project to, one, prove that we could actually do it, provide a more intensive intervention, and two, that anyone would come to sign up for more intensive intervention.
And this article has to do with the inpatient treatment program for patients with severe nicotine dependence, people who had tried to stop smoking in every other way that they could do, or may have had very severe medical complications, may have had emphysema or peripheral vascular disease, hardening of the arteries or other conditions and were unable to stop smoking despite having that. So this project was to see if people would check into a hospital, basically, like other people would check into a hospital for treatment of their other addictions like cocaine or alcohol or opiates or other addictions. And we had people to come for this.
And that article actually describes the program, describes the outcome. And the outcome, though it was good, it was less than we liked for it to be. I think around 28 or so percent of the people that came to that program were able to stop smoking and maintain that abstinence even though they were hospitalized for two weeks and received everything that we could provide for them. So these people were really severely ill with a severe degree of dependence.
Q. Another article, doctor, is entitled "Serum Nicotine and Cotinine Levels During Nicotine Patch Therapy" which was published in the peer review article Clinical Pharmacology and Therapeutics. Can you briefly describe that article?
A. Well that actually had to do with this -- this project we just talked about where the people were in the hospital for a period of two weeks and we would draw their blood every day to see how much nicotine was in their blood. And cotinine is the other thing that -- that he mentioned. Cotinine is a metabolic product of nicotine and it's easily measured in the blood or even the saliva or the urine of a person who is using nicotine replacement therapy or is a smoker.
So we measured the levels when they were smoking their usual amount of cigarettes to get an idea of what their baseline level was, and then we measured the level every day while they were in this smoke-free, intensive inpatient treatment for their dependence. And they compared the levels. And so what we found was that at the time that they were smoking their usual number of cigarettes, their level was about here, and we put them on a single-dose nicotine patch which delivers 22 milligrams of nicotine per day, and we looked at the blood levels while they were in the unit. The blood levels were about half of what they were when they were smoking their usual number of cigarettes.
And we concluded that we were probably underdosing a fairly large number of people if we only gave them one nicotine patch. So it was a way of looking at this and doing a -- a fairly sophisticated study of -- of pharmacologic therapy, but determining what -- what they had to begin with and what they were on a single-dose patch.
The analogy I guess I would se would be -- or what we found was that one patch does not fit all smokers because some have higher levels, higher levels of dependence. It would be like a person with diabetes. Every -- every diabetic would get the same dose of insulin, and it just doesn't work that way.
We have to individualize the treatment.
Q. Doctor, there was another article published in JAMA which was entitled "Nicotine Patch Therapy for Smoking Cessation Combined with Physician Advice and Nurse Follow-up: One-year Outcome in Percentage Nicotine Replacement." Was that part of the same program?
A. No. This was a different study. This was a very large study that we did in three -- three different places actually, Mayo Clinic Scottsdale, Mayo Clinic Jacksonville and Mayo Clinic Rochester. We had several hundred patients in this study and we did the same thing again, but we did -- we measured their levels while they were in their free state, smoking their usual number of cigarettes, but then they just received advice from the physician and follow-up by a nurse. They weren't in the hospital for inpatient treatment, they were in their free- living state to see what happened as far as the outcome, how well they were able to do as far as stopping smoking, but also to try to figure out what the percentage of replacement is. If their level was this at the beginning, what kind of legal did they have when they were on the nicotine patch.
Q. Okay. Another article that was published in the Alcohol Clinical Experience and Research Journal is entitled "Nicotine Dependence Treatment During Inpatient Treatment for Other Addictions: A Prospective Intervention Trial." First of all, what's a prospective intervention trial?
A. Well there -- there are kind of two types of studies. One is prospective, where you figure out ahead of time what you're going to study so that you can collect the information and you end up with better information because you don't have missing information. So prospective means that we thought ahead of time what we were going to do before we recruited the patients to go into this study.
A retrospective study is something that's happened in -- that's already happened in the past and we're looking back into the past to see what happened with -- with the patients.
The first study Mr. Ciresi mentioned of The Smokers Clinic was a retrospective study. We looked backwards in time to see what happened to the people and to figure out how -- how well they did with The Smokers Clinic intervention. So a prospective study is generally thought of as being more scientifically sound because you're able to figure out what you want to collect before you actually start the study.
Q. Are those two types of what are called clinical trials?
A. Well a clinical trial would be where there's a medication involved or a drug involved, and those would be prospective, but they would be randomized clinical trials, "randomized" meaning the assignment to the drug or to the placebo is done at random, by chance. And "double blind" meaning I don't know what you're taking and you don't know what you're saying, so that we can be fair in the assessment of that, so we don't do something more for the people who are receiving the drug as opposed to those that are receiving the plabebo. So I'm blinded to it, our staff is blinded to it, and the patients are blinded to it, so that we get a very good assessment of the effect of drug.
Q. Can you tell us, then, what the article -- or the study was about in the Alcohol Clinical Experience and Research?
A. This is actually one of the very first articles that -- that looked at the issue of treatment of nicotine dependence in people with other addictions. Up until that time the treatment community, if you will, that -- that encompasses all of the addictions treatment field, had embraced all the other addictions, but nicotine dependence was kind of left out of -- out of the equation, and up until the early 1990s smoking was still allowed in the addictions unit at our place and in most places around the country, because there was a fear that if you tried to help people stop smoking at the same time they were going through their other addictions treatment, maybe for cocaine and alcohol or other -- other drugs, the fear was that if you treated their nicotine addiction at the same time, that you might have an adverse effect on the treatment of the other drugs.
And -- and so we did this study to see if we could provide an intervention for patients that were undergoing treatment for their other addictions at the same time. And what we found out was that we could do that, and that though it was modest, there was a success rate that was better for those that received the intervention compared to those who did not.
And then the third thing is that even though they may have received intervention for the nicotine dependence, that did not make them relapse to alcohol use or other drug use in a higher rate than you would expect from the control group. So it was really one of the first studies to address the issue of the seriousness of nicotine dependence in people with other addictions.
Q. Doctor, another article that was published in 1995, again in JAMA, was "High-Dose Nicotine Patch Therapy: Percent Replacement in Smoking Cessation."" Can you briefly describe that study.
A. That really fits into kind of the train of research that we were doing. In the initial work we found out that the levels that the people had when they were smoking were higher than we would ever be able to achieve with a single-dose patch, so this study actually -- we put people in the hospital again, measured their blood levels and urine levels when they were in their free-living status and then put them in the hospital for an intensive inpatient treatment program, measured their blood levels twice a day, collected all their urine, collected all kinds of other specimens and samples, and then also gave them treatment for their -- their nicotine dependence at the same time. And this one was different because instead of giving one patch at a time, we gave two patches. But it was blinded, it was randomized and it was controlled, so some people got two patches, two active patches, and some people got one active patch, regular size, and some people got a small active patch and some people got a placebo. Everybody wore three patches at a time, so we didn't know what they had, they didn't know what they had, and measured the levels and we found with the higher dose levels that we could get better replacement, as you would expect, get higher levels that came closer to what they had when they were in their free-living state and smoking their usual number of cigarettes, and those that received lower doses had lower levels.
And then the second part to that is the outcome, who did better as far as stopping smoking? And as you'd expect, the people that had higher doses, higher percentage replacement, did better as far as their ability to stop smoking.
Q. Another article that was published in JAMA was the "Mortality Following Inpatient Addictions Treatment: Role Of Tobacco Use in a Community-Based Cohort." First of all, what's a community based cohort, doctor?
A. Well in Rochester we have the ability to kind of follow people over time through our medical index system, and so that -- that makes it a population-based cohort. "Cohort" is just a collection of -- of people in -- either a certain group of people or a certain geographical area. This was a retrospective study where we looked backwards in time, identified people who had been through our addictions treatment program, and then followed them forward in time to see what their outcome was, what happened to them. And the main -- the main thing we did as far as the main outcome we measured was whether or not they lived or died. Mortality.
So mortality is, in outcome language, it's probably the ultimate outcome. And so by measuring that we can measure it through death certificates and have a very finite end point.
So these people had been in treatment for their alcoholism, and it dated back to the early 1970s and went forward to the early 1980s, and we followed them through our index system until the early 1990s. And what we found was that the people who had been in treatment for their alcoholism and other drug dependencies died at a higher rate than you would expect for the general population. A much higher rate.
The second thing we found, when we looked at the causes of death in those people who died using a standard classification system from the Center for Disease Control in Atlanta and relating those to alcohol-related diseases or tobacco-related diseases, over half -- over half of the people died of tobacco-related diseases like lung cancer, heart disease, emphysema, and only about a third died of alcohol-related diseases. And the message of that study was that if you're going to be treating people with this kind of problem, then you need to pay attention to their nicotine dependence because it's responsible for over half of the mortality that will occur in the future. And if you're not going to treat that, then that's really not good practice. And that's really had an effect on the -- the community of -- treatment community for people with other addictive disorders because -- because it has the message of mortality rather than other outcomes.
Q. So that these -- the cohort here and the people you were looking at were those who had alcoholism?
A. And other -- and other addictions. It may have been alcoholism plus other -- other dependencies. Had about 75 or so percent or 80 percent were also nicotine-dependent. But we took all the outcomes, we didn't slice it any way. Every outcome was taken at the end. Even though they may have been a non-smoker -- there were a small number that were non-smokers in the cohort, so that's still included in the bottom number, the denominator of the equation, and the top part of the equation is the people who died over the 800 or so people who were -- who we followed over time.
Q. Doctor, another article is entitled "Nicotine Dependence Versus Smoking Prevalence: Comparisons Among Countries and Categories Of Smokers," which was published in 1996 in Tobacco Control. Can you describe briefly that article?
A. Well this was a cooperative effort from other people in other countries. After you've been doing this for a while you get to know people from other places, and the person that was the lead author on this was Dr. Fagerstrom, who's a scientist from Sweden, and he was interested in knowing what the ratings of nicotine dependence were in -- from one country to the other, and he developed many years ago a questionnaire that is used throughout the nicotine dependence treatment community that defines, as best we can, degree of dependence. It's called the Fagerstrom Tolerance Questionnaire.
So he was interested in knowing what might be differences from different countries of the score on this particular test, which gives a gauge of how dependent a population might be. And so that's really the thrust of that study, to see what the dependence level was of different populations.
Q. And what was found in that study?
A. It varied, and it varied according to the studies. People who may come to a clinical treatment program like ours that we would run for a nicotine patch study might have higher levels on the Fagerstrom Tolerance Questionnaire than people who were just asked the questionnaire as part of another medical encounter. So people seeking treatment might have higher levels of dependence.
Q. The questionnaire you mentioned, what was that called in?
A. The Fagerstrom Tolerance Questionnaire.
Q. Can you describe what that is for the ladies and gentlemen of the jury?
A. Well it's -- it's a series of questions that has to do with smoking behavior. One of them has to do with how long after you get up in the morning do you have your first cigarette? It also has how many cigarettes a day that you smoke. Do you smoke in places that it's normally forbidden to smoke, like theater is and churches? And all those things have to do with what we term the level of dependence. A person who would smoke in this courtroom I would suspect would have a very high level of dependence, otherwise they wouldn't -- wouldn't be doing it. So those are the kind of questions that are there.
And a person who gets up in the morning, like I used to, before my feet hit the floor I would have my first cigarette going. So that person would fall into the category of having a higher level of dependence because I would be smoking the cigarette earlier than someone who could wait until 30 or 40 minutes or an hour or two after they got up in the morning.
It's just a gauge or a measure on how dependent a person might be. And it's not -- it is the best tool we have right now, but it's not perfect.
Q. Doctor, there's one other article that was published in Pediatrics in 1996 which was entitled "Nicotine Patch Therapy in Adolescent Smokers." Can you describe what the nature of that study was?
A. In all the work that's been done about adolescents, and as you all probably know, if you don't start smoking by the time you're 21, the likelihood of you being a smoker later on is very small. Actually, if you don't start smoking before the age of 18, the -- the chances of you becoming an adult smoker are very small.
And there's been a lot of effort expended in the public health community to try to help understand how to prevent kids from starting to smoke. There's been a lot of effort in that regard. But there have been very few efforts to try to treat teen-age smokers, to try to help them to stop smoking. The assumption had always been that kids aren't particularly interested in stopping smoking, and that was a bad assumption. And so when you looked at the literature, when we looked at the literature to find out, well, what is there out there about treating adolescent smokers, and by this I mean age 18 -- under age 18, there really wasn't very much available. So we did this as a pilot study to see, one, if any -- any teen-ager would come to be treated for their nicotine dependence, and two, what the safety of the use of this product would be in children. We know what it was -- we know it was safe to use in adults, but we'd never used it in children. No one had ever used it in children. And then the third was to see if we could help them stop smoking.
So the answer was we -- we had kids who wanted to stop smoking. When we --
One of the things you have to do when you do adolescent study, you have to have parent consent, which is a little bit of a barrier, because when we put the notices out in the schools and in the newspaper, we had a -- had a program for adolescent smokers, we got a lot of telephone calls, and they were very interested until we said well you need to come to this information meeting and, oh, by the way, you have to bring your mom, dad, or your guardian to sign for you. So the numbers went down a lot with that. Nonetheless, we had 22 kids who signed up for this program.
The patch was safe, it didn't cause any adverse events. And unfortunately, only one of the 22 was able to maintain her abstinence over the entire year after being treated in a standard course of therapy. A large percentage of them reduced their smoking, but only one was able to stop smoking.
When we did this questionnaire, the Fagerstrom questionnaire, the results of that were basically the same as you would see in adult smokers. These kids were as addicted as their adult counterparts.
Q. Now have you made, in your field of specialty, presentations at various national meetings?
A. I have.
Q. Okay. You've spoken at the Seventh World Conference on Tobacco and Health in Perth, Australia, in 1990?
A. Correct.
Q. You spoke at the Eighth World Conference on Tobacco and Health in Argentina in 1992?
A. Yes.
Q. And the Ninth World Conference in 1995 in Paris, France?
A. Correct.
Q. And you've also been invited to speak at various educational institutions around the country and the world?
A. Correct.
Q. You've spoken at Johns Hopkins Symposium on New Developments in Nicotine Delivery Systems?
A. Correct.
Q. At the University of Texas, the Southwest Conference on Nicotine Dependence?
A. Yes.
Q. At the University of South Dakota for Nicotine Dependency Treatment Program at the Internal Medicine Grand Rounds?
A. Right.
Q. At Indiana University, Smoking Cessation Treatment: Trends in Smoking and the Benefits Of Quitting?
A. Correct.
Q. At St. Louis University -- excuse me, Washington University in St. Louis, Missouri, Smoking Cessation in the Primary Care Practice?
A. Correct.
Q. At the University of Tennessee, Update on Addiction Treatment?
A. Correct.
Q. Louisiana State University, Conference on Smoking Cessation in Nicotine?
A. Uh-huh.
Q. At the Henry Ford Hospital in Detroit, Michigan, Indicated Nicotine Dependence Therapy?
A. Correct.
I might add at that particular institution, they have adopted the model that we started at our place and have now a nicotine dependence treatment program similar to but not -- not to the extent that we have.
Q. How many programs are there like that in the country, doctor?
A. Like our program?
Q. Yes.
A. I don't know of any other one that's like this, that integrates practice, education, research, one, and two, that has the levels of intervention, because we have individual treatment, group treatment and inpatient treatment for the patients. So that's really the only one that I'm aware of that's like that.
Q. You've also spoken at the Wayne State University, Michigan Cancer Foundation in Detroit, Michigan?
A. Right.
Q. And at the University of Nebraska Medical Center, The Use of TransDermal Nicotine for Cigarette Smoking Cessation?
A. Correct.
Q. "Transdermal," those are patches?
A. That's correct, yes.
Q. You've also given testimony in front of the FDA Drug Abuse Advisory Committee?
A. That's correct.
Q. And you've spoken at the University of Wisconsin, LaCrosse, on going smoke-free?
A. Yes.
Q. Free workshop for businesses and restaurants?
A. Yes.
Q. And you've also spoken at the American Psycological Association in Toronto, Canada.
A. Yes.
Q. And at the Iowa Academy of Family Physicians in Des Moines, Iowa?
A. Yes.
Q. And at the American Society of Clinical Oncology in Denver, Colorado, Clinical Trial Outcomes and the Treatment of Nicotine Dependence in Medical Settings.
A. Yes.
Q. "Oncology" is a word for cancer?
A. Oncology is the treatment of cancer. That's the whole field of cancer treatment.
Q. Now you also are a scientific reviewer for various peer-review journals?
A. I am.
Q. Can you describe what a peer-review journal is?
A. A peer-review journal is -- is like the Journal of the American Medical Association or the Mayo Clinic Proceedings or the New England Journal of medicine, which receive articles from people who are writing about scientific work, and "peer review" means that -- that the articles then are received by the journal and then sent out to peers. So I might be reviewing articles about smoking cessation or nicotine dependence treatment or nicotine patch therapy for people who might be writing it from another part of the country, they sent their articles to the journal and they send them out to reviewers who review the articles anonymously, and then send them back to -- it's anonymous to the author, but it goes back to the journal, and then they determine whether or not they're going to publish the article.
So it's -- it's really the highest level, if you will, of journal review process. And it's very difficult. When you have an article that's in the Journal of the American Medical Association, you've gone through a lot of effort to get it there. The science has to be really very good. The writing has to be clear and very good. So it's a -- it's kind of the standard that we look at as far as science within medicine.
Q. Okay. And some of the journals that you have peer reviewed for are Addiction, Alcohol Health and Research World, American Journal Of Epidemiology, Annals of Internal Medicine, Chest, Drug Evaluations, JAMA, which is the Journal for the American Medical Association.
A. Uh-huh.
Q. Journal of General Internal Medicine, Journal of Internal Medicine, Journal of Studies on Alcohol, Mayo clinic Health Letter, Mayo Clinic Proceedings, The New England Journal of Medicine, Patient Care, section editor for the Mayo Clinic Family Health Book, Tobacco Control International Journal, and the Western Journal of medicine?
A. Yes.
Q. And during the course of your career have you also received various research grants from the National Institute of Health and other companies?
A. From companies and the National Institute of Health. From pharmaceutical -- pharmaceutical companies, yes.
Q. Doctor --
A. I'd like to clarify that the Mayo -- Mayo Clinic Health Book is not really a peer-reviewed journal. It is peer reviewed, but it's a -- it's a family health book that people buy. So it's listed there. But it's not, quote, peer reviewed in that sense.
Q. All right.
A. Carefully written, but not peer reviewed.
Q. Let me direct your attention back to the Nicotine Dependence Center at the Mayo Clinic, and I'd like to go to the origins of it so that the court and the ladies and gentlemen of the jury have an understanding how that Nicotine Dependence Center came into being.
It was first called the Mayo Smoking Clinic?
A. Let me just get a drink.
Well the origins of the Nicotine Dependence Center actually came from The Smokers Clinic that we talked about earlier. And as I said earlier, in 1975 there was very little that was available for patients. We could do heart transplants, kidney transplants and other things, but we only had this one community-based program for patients who were trying to stop smoking.
So I actually went to that program. My wife called me at work one day and said, you know, we need to do something about our smoking. I've signed us up to go to The Smokers Clinic. And The Smokers Clinic was the only thing that we had available. So we went.
I was able, fortunately, to stop smoking as a part of that. It was before patches and gum and things like that. It was the hardest thing I ever did. And as a result of that, I then went back as a group facilitator, because I had had training in my -- in my internal medicine program where I went through the addictions unit and had training there, and I had skills as -- as a counselor or a person to lead groups. So I came back as a facilitator for their groups after -- the program after I went through it, and did that for a few years actually.
Dr. Hepper, who was the -- one of the founders of The Smokers Clinic then decided not to be the medical director of it any more, and they asked me if I would do that. This is after I'd joined the staff of the clinic in 1976. I think I became the director in 1977. And I oversaw the work of that Smokers Clinic over the next few years, and as a result of that developed a real keen interest on how to refine that.
At the time we started -- or at the time that I went through the program, there was a little bit of a mention about addiction but not very much. It was mainly behavioral treatment, teaching people how to recognize the cues to smoke, what to do about the trigger situation and how to overcome that, how to overcome the urges to smoke, how to overcome the withdrawal symptoms that might be present, to teach them the behavioral parts of that. So after I became the medical director we began to integrate into that a lot of the things that I knew about addiction medicine which I'd learned from my internal medicine fellowship and my rotation through the psychiatry unit as well as the addictions unit. And we began to really understand that this was something well beyond behavior. There was a very severe and serious addictive component to it.
Because recognizing the groups of people that we were seeing, that they had the same hallmarks of people that I'd seen earlier in our addictions treatment program: rationalization, denial, loss of control, getting up every morning saying well I'm not going to do this all over again, I'm not going to smoke as much today as I did the day before, but not having the ability to control that. And so we began to integrate into that program the addictions philosophy, if you will.
Now I'll never forget, it was in -- probably in the mid-1980s, I was on hospital rounds. As an internist we make hospital rounds to see patients in the hospital. And received two phone calls in the same day from people that were hospitalized, and at that time we still allowed smoking in the hospital, this was before the smoke-free policy, who had serious limb-threatening vascular disease, they had hardening of the arteries to the point that they had ulcerations on their feet and they were in danger of losing their feet -- or their legs. And desperate phone calls from the vascular service on the one hand and the dermatology service on the other. What do we have to offer these patients? And we didn't have anything to offer. We had no treatment facilities for them. We could do all kinds of surgery and all kinds of medical procedures and such, but we did not have a treatment program for patients with these life-threatening medical complications of their nicotine dependence.
After that we got a group of people together to try to see if we could develop a set of programs that we might get approved through the institution. We brought that to the institution's attention in 1986 or so, and there was a two-year planning process after we got approval to actually implement the program, which we described earlier. So we started seeing our first patients in April of 1988 and have moved forward to continue to refine and develop more and -- more programs and more effective interventions as we've gone along.
Q. Now you deal with different types of patient groups? By that I mean outpatient or inpatient, or is it all inpatient?
A. No. I want to make sure everybody understands that. Most of the people that we see are referred by a physician from within the complex, and most of those are outpatients. They're coming to be seen for whatever problem they may have, and maybe -- they just may be there for a health maintenance examination, just a regular checkup. And I should also tell you that -- that Mayo Rochester, though it has an international reputation, it's really a regional -- a regional facility.
And you have to think about it kind of in concentric circles. In the center circle is Rochester and Olmstead County, and I as a primary- care physician take care of patients from that innermost ring around -- around Rochester. And there are family physicians and there are obstetricians and pediatricians that do the same thing that I do. Then there's another layer around which is kind of a regional practice, and outside that is the rest of the country and the rest of the world.
If you go from the middle part, a very large percentage of our patients come from Olmstead County. If you go to the next level, over half of all the patients seen at Mayo Rochester are from Minnesota. Over 80 percent of the patients who are seen there come from within 500 miles. And only a very small fraction, though they get all the headlines, only a very small fraction come from far away and are the famous people. We really take care of people from all walks of life.
So those patients that might be referred for treatment that would be seen on an outpatient practice would -- would reflect that. They would be a lot of local patients, a lot of people in Minnesota, Iowa, Wisconsin, and a few from afar.
Then we do see people in the hospital. We provide these same kind of counselor services and intervention services for patients in the hospital. Then the treatment services are kind of in three different tiers: outpatient treatment, group -- group therapy where they come in for special longer sessions, and then the most intensive level of intervention is the inpatient treatment program.
And so you kind of put the numbers together, we've seen the most patients in the outpatient individual one-to-one counselor intervention, and the fewest in the inpatient program. About -- we've had about 250 people in the inpatient program out of the 15,000 or so that we've seen total.
Q. Now are they inpatient just for nicotine addiction, or is it inpatient for other reasons also?
A. It is inpatient for nicotine dependence only. We try to address other things, but it's only a week long and things are very complicated, very difficult patients who are having a hard time with this.
Q. Now earlier in your testimony, doctor, you had mentioned the aspects of treatment, and I think you went through them fairly quickly. They were behavioral treatment, addiction treatment, pharmacological treatment, and then relapse prevention I think you mentioned.
A. Right.
Q. Can you describe each one of those categories or segments of treatment that's undertaken in the Nicotine Dependence Center at the Mayo?
A. Okay. All of the counselors are fully trained in all four of those areas, and if we have a counselor who has had training in addictions, like they may have been in -- three of our first counselors had been counselors in our adolescent addictions unit before they came to work for us. So they had -- they had a real good understanding of addictions treatment, but we had to teach them more about the pharmacologic treatment and behavioral treatment. So if you just kind take them as a list, we need to make sure that all of the counselors are trained in all four of these things.
Behavioral treatment goes back many, many years. The behavioral -- behavioral medicine has been -- they've been treating patients with nicotine dependence for a long time. Behavioral treatment, as we mentioned earlier, would be having the smoker to go through a list and recognize their cues to smoke, recognize the triggers to smoke, recognize the situations that they might put themselves in, helping them to understand and develop skills and helping them develop skills to reduce stress, stress management, help them to develop skills to cope with situations in a different way rather than just smoking. So those are kind of the behavioral skills that we talk about.
Q. Doctor, if I could interrupt you there, you used the term a couple times "triggers" and "cues."
A. Right.
Q. Can you describe what that is? What's a trigger and what's a cue?
A. Well a cue is kind of the word that's used by people in the behavioral field. Trigger, if you -- for me, after I'd stopped smoking even just for a little bit, there would be a situation that would occur like a cup of coffee, or talking on the telephone, driving the car. I didn't really realize until much later that the car actually would start without me lighting up a cigarette, because the ritual was get in the car, put the key in the ignition, put the lighter on, get the cigarette out, by that time the lighter had popped out, put the cigarette in your mouth, light the cigarette, and then start the car. So that was -- so I had to recognize I need to unhook from that behavior. So that was a cue. That was a trigger.
Q. So it triggers a memory of smoking; is that --
A. It cues --
Actually if you get down to the pharmacology of it, it triggers the response that happens in the brain to very high levels of nicotine that get into the system when you smoke a cigarette, because a cigarette is the most efficient delivery form of nicotine that exists. It's better than intravenous. The levels you receive in the brain are very high, and the outcome of that is the sensation that you receive there is part of the cue response, it's part of the trigger response. And even people who have stopped smoking for a long time, maybe even a year or so, will have certain situations that will trigger that memory, if you will, of what it was like to have those levels of nicotine in their brain. And so they -- they remember.
It's like if someone would light up a cigarette across the room and it was a fresh cigarette, had that smell to it that was a fresh cigarette as opposed to stale-smelling cigarette, that might ignite this cue response. A glass of wine, a cup of coffee, a fight with a spouse. I mean there are all kinds of responses that would -- where a cue response or a trigger that might occur.
So we need to teach the patients what do you do? What do you do the next time you have that stress or that situation, how do you avoid that urge to go ahead and have a cigarette. And people had to remember that the urge to smoke, those cravngs, though they may be very intense, they're very short. That's one of the things we try to teach them.
But the teaching has limitations, and that's where the addictions part of this comes in. Behavioral treatment or teaching a person about their own behavior and what they're going to do about it is only part of the equation. It has limitations. And by that I mean the -- the patients have to really understand that -- that we're dealing with an addictive process, an addictive disorder. So though we can teach about all these things, sometimes the overwhelming urge is the drug driving the equation. The drug is taking control and the person with the problem has no control over that.
And there's a tendency on the part of most smokers that we see who have -- have nicotine dependence, to use the same things that other -- other people with other drug addictions would: rationalization, denial, not recognizing that they've lost control. And so those are the things that have to do with addictions treatment that both the counselors and physicians need to understand. Because the tendency is to blame the smoker, and -- and the smoker isn't the problem, the drug is the problem. The drug has exercised an element of control over the individual and their behavior.
Q. Now you say the counselors have to --
THE COURT: Counselor, counsel, why don't we take a short recess.
MR. CIRESI: All right.
THE CLERK: Court stands in recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
Please be seated.
BY MR. CIRESI:
Q. Doctor, I'm going to ask you to repeat your name real loudly. Some of the jurors did not hear your name when we first started this morning.
A. Okay. My name is Richard Hurt, H-u-r-t. Like a pain, so to speak.
Q. Doctor, when we recessed, we were talking about the four categories of treatment at the Nicotine Dependence Center and we were on that category entitled addiction treatment. And one of the points you had made is that the counselors must understand the issues that the individual smoker is dealing with, and can you describe what you mean by that?
A. Well it -- it actually goes back to one of the training encounters, and actually when we have our training seminar to train people from other institutions who want to learn how we do what we do, that's one of the key points, because we've always heard about the behavior of smoking but we need to learn and understand the addictions part of -- of smoking and nicotine addiction and how that works. And so what I think I was getting ready to explain was those things have to do with denial, rationalization.
Denial is like I might have a -- a pulmonary problem, a lung problem, emphysema for example, or even chronic bronchitis, and to be able to mentally detach from that and deny the connection between my smoking and that lung condition, it would be like a person with alcoholism who has cirrhosis but is able to deny and rationalize that those two things aren't connected. That is the addiction part of this. That is the drug speaking as opposed to the individual.
And so the tendency, as I said, I think, earlier, is to blame the smoker for this, and really it isn't the smoker at all, it is the drug itself that is in control of those situations. And so the denial and rationalization that occur have to do with loss of control.
Q. Okay. And what type of treatment is rendered in this phase in the addiction treatment? What is done?
A. Well it's mainly counseling, because it's important for the patient to understand this so that you don't feel guilty about this. I mean there's enough guilt amongst people who are smokers already, and so if they understand that it is a loss of control and that we're dealing with nicotine as a drug of dependence or a drug of addiction, then it's helping them to step back a little bit and understand -- understand that and to -- to know that we're talking about a biochemical phenomenon, not just something having to do with I'm -- I'm a bad person, because that's just not the case. And smokers are ordinary people who happen to be dependent upon the drug and the drug is called nicotine, and when it's delivered by the most efficient delivery device available, the cigarette, it produces high levels of addiction.
Q. Now the other -- the third category of treatment you mentioned was pharmacological treatment. First, can you describe what "pharmacological" means?
A. Well pharmacology is the study of drugs and the way drugs work in the body. And this is kind of the newest area that we have available. As I think I mentioned yesterday, nicotine patches have been around for -- well, for seven years now. Nicotine gum has been around for maybe ten years. And those -- nicotine gum was the first pharmacologic treatment that we had available to help people stop smoking. The patches came out. There is a nicotine nasal spray, another delivery device for nicotine. There will be a nicotine inhaler next year, which is a little puffer that people with puff on to get nicotine inside their mouth. So those are kind of the nicotine-delivery devices that -- that we have to treat patients.
And then probably the most exciting thing that's happened more recently is that we have a non-nicotine drug to help stop smoking, it's called bupropion, the trade name for it is Zyban, and we published an article in the New England Journal of Medicine just last year to do with that drug. It's a very helpful treatment, it's not a cure-all.
So those are kind of the things we talk about when we talk about pharmacologic therapy. So it's -- it's an expanding area. We're now using those drugs in combination, patches plus bupropion, nasal spray plus patches. We're trying to figure out different combinations to help people stop smoking better. And kind of the -- we're at the very early phase of the understanding of the biochemistry of all this and the biochemical reactions that occur in the brain.
This last drug I mentioned has to do with dopamine. Dopamine is a transmitter in the brain that has to do with pleasure and reward when it's released in certain areas of the brain, and those areas are activated by drugs of dependence like cocaine, opiates and nicotine. And so this drug has to do with dopamine. It actually increases the level of dopamine in the brain and helps people stop smoking through that mechanism.
So we've learned a lot in the last ten years on how best to treat patients using pharmacologic therapy, but we've got a long way to go. We're kind of where we were, you know, 50 years ago when we only had penicillin and sulfa drugs to treat infections. We're kind of at the beginning of this. And in the next ten years I suspect we're going to learn a lot more.
Q. Now the last stage or category of treatment was what you designated relapse prevention. Can you describe what that is, first of all, and then secondly what it entails?
A. Well as you probably know, people who are smokers, who stop smoking for a little while, tend to relapse. For example, people who see one of our counselors in our program and receive all that they can give in an individual counseling session and have the follow-up visits and so on with the counselors, only about 22 percent of those people will stop smoking and remain abstinent at the end of one year. And some may start out by -- by being abstinent or having stopped smoking for a few weeks, but then relapse. They come under a stressful situation or they have some cue to smoke or they let their guard down and think they can just have one, which isn't really possible for most of us. And so we need to figure out how better to help them in those situations to avoid relapsing. So that whole area has to do with preventing relapse.
So we teach them a lot about it, talk to them a lot about it, and then we call them up on the telephone at specified intervals, one month, three months and six months, and try to maintain contact with the patients to help them through those situations. We send them a series of letters. So we try as best we can to maintain contact with the patients in order to help them not to relapse, and if they do relapse, to let them understand that there is more treatment that we can provide for them.
Q. Now you said that only 22 percent at the end of a year, one year, are not smoking.
A. Right.
Q. Is that dependent upon whether they were had inpatient, outpatient, or is that across the board?
A. That's kind of across the board. For people who receive the individual treatment or the individual -- and it's really very brief, it's one consult with -- the counselor spends 45 minutes or an hour with the patient, and that may be the only time that they have to spend with them. They may have a follow-up visit, but it may be just the one. So it's really -- If you look at the overall statistics of people that stop smoking and the whole -- whole realm of smokers from one year's period of time, probably less than five percent of smokers who try to stop are able to stop smoking on their own. If they see a physician, we can double that rate to around 10 or 11 percent. If the physician has some intervention they provide to the patient, and with our counselor intervention, we can provide upwards of 22 or so percent, so it's a four times as good as trying to stop on your own. And then if we go to the higher levels of intervention, like the inpatient treatment program, 43 percent of those are able to stop and maintain their abstinence for a year. Which on the surface sounds really good, but at the same time there's a large number that relapse too. The majority actually relapse.
So this is an area where we know the least about this as far as how to do it and provide relapse prevention for -- for the patients.
Q. How much of your career, doctor, at the Mayo is spent on nicotine addiction and the treatment of it?
A. About half the time right now. It varies. It's hard to gauge that because the work week is long, and in the 50-hours-or-so work week, it would be about half the time, maybe 60 percent of the time is spent only in nicotine addiction treatment and helping the counselors, helping the patients.
Q. Now in 1995 were you asked to consult with the state of Minnesota and Blue Cross and Blue Shield in this case?
A. I think that's right, yes.
Q. Have you ever testified before?
A. No.
Q. Did you have to get approval from the Mayo Board of Governors in order to testify?
A. I did. And this is a little bit of an unusual situation. I asked for permission and had -- that had to be approved at the highest levels of our institution, which is the Board of Governors which oversees Mayo Clinic Rochester, but also had to be approved of the Board of Trustees, which is kind of the next level up, and they approved my participation in this case.
Q. Now you've conducted an investigation in order to prepare yourself to testify here on the issues that you're going to be facing?
A. I did.
Q. Did you look at internal documents from the industry?
A. I did.
Q. Did you request documents from our law firm that we obtained from the defendants so that you could review them?
A. Correct. My area of interest and expertise has to do with what we've been talking about, which has to do with addiction or dependence, has to do with what happens in people who smoke and how they might compensate if there is a lower delivery systems that might be available. Those are two of the areas I requested information on, how nicotine may have been changed or manipulated as far as the form is concerned and how that might affect the addictive potential of the drug or -- or the areas that -- that I had interest in.
Q. And doctor, before you looked at those documents, had you kept abreast of the literature in nicotine addiction and dependence?
A. Correct. It's -- it's --
When you get to kind of this stage, it's not hard to because you end up reviewing articles that are sent, you get phone calls from colleagues around the country, so it's kind of a continuous education process almost on a daily basis.
Q. That would be a normal state of affairs for doctors. You keeping abreast of information as you go along?
A. Well as best you can. But when you kind of get into a special area like this, there -- you may get a phone call from someone wanting to know what this blood level means. And that happens probably every -- every other day or several times a week. A patient is being seen, say, at Indiana University that's on the transplant list for a heart transplant, and one of the -- one of the issues with heart transplants and lung transplants is whether or not the person is continuing to smoke. Which people say, well, that's -- why would anybody continue to smoke if they're trying to get on a transplant list? Well, it really has to do with the degree of dependence or addiction that the person has.
We've got lots of patients who continue to smoke even though they have a severe tobacco-related disease who may be on a transplant list or trying to get on a transplant list. So --
Just last week I got a phone call from Indiana University. They wanted to know how to interpret a cotinine level in a patient that they were proposing to put on the transplant list. So I get -- those sort of calls come in. And just as a result of those things you kind of have to keep up. So that's a little bit different than -- than my internal medicine practice where I have to -- have to go to the journals and the textbooks and so on and kind of keep up on our own. These things make me keep up because I get inquiries from around the country.
Q. Did the documents of the defendants that you reviewed expand your knowledge base with regard to nicotine and its addictive capabilities?
A. In ways that -- that are just hard to describe. I -- there are some areas that we'll probably get into that -- that I had not even dreamed that there was this much work that had been done over the years. Specifically with regard to pH and nicotine manipulation, those were things that were basically not known to the level that -- that they're known in the internal documents.
Q. And you've prepared an expert report in this case?
A. I did.
Q. Did anybody tell you how to testify or how to limit your opinions in any way?
A. No.
Q. Now you've been asked to give your expert professional opinion on the following subjects, doctor: whether nicotine is an addictive drug; correct?
A. That's correct.
Q. Whether the defendants knew they were selling an addictive drug.
A. Correct.
Q. Whether nicotine in free base form maximizes its potential to addict smokers.
A. Correct.
Q. And whether the defendants intentionally misrepresented the health risks of smoking by marketing low tar/low nicotine cigarettes as health reassurance products.
A. Correct.
Q. And also whether the defendants intentionally misrepresented the health risks of smoking by creating doubts about the health risks.
A. Correct.
Q. And finally, whether the defendants' actions were a substantial contributing cause to people smoking.
A. Correct.
Q. Okay. Are you prepared to express your opinions on those subjects here during the course of your testimony?
A. I am.
Q. Okay. I'd like to review with you, doctor, the type of information that you have examined that forms the basis of the opinions that you're going to render here over the course of the day and probably tomorrow.
First of all, in your training and in order to prepare yourself for dealing with the Nicotine Dependence Center at Mayo, have you familiarized yourself with the history of smoking?
A. I have.
Q. And do you at the clinic in the Nicotine Dependence Center utilize an historical perspective of the use of tobacco for the purpose of treating patients?
A. It's important for them to understand. Yes.
Q. Can you turn in -- I believe it's book number one in front of you -- actually it would be book number two. I'm sorry.
A. Okay.
Q. -- to Exhibit 30083, and I'd like you to describe briefly as we go through these exhibits, which are for illustrative purposes only, the history of tobacco in this country.
A. Well the way that -- that I explain this to our staff and to our patients --
MR. BERNICK: Your Honor, I object to this line of questioning. I don't think there's a foundation for it. I'm prepared to conduct some voir dire.
THE COURT: Overruled. You may answer.
A. In understanding the issue of the current use of tobacco, it's important for all of us, and especially for the patients and for the field, to understand where we've been for the last several hundred years. There is this thought out there that cigarettes have been around since the beginning of time, that they're somehow mentioned in the Constitution or the Declaration of Independence, but cigarettes did not exist in those days. Cigarettes are a modern phenomenon, and though they existed in the latter part of the 19th century, they really are a 20th century phenomenon that has occurred. So it's helpful sometimes to kind of go through some of the history of this, and -- and that's what's outlined on -- on the overhead.
Everyone knows that tobacco has been around for a long time, that people have used tobacco since antiquity. And it's actually a Western Hemisphere phenomenon. The natives of North Central and South America use tobacco for a lot of different reasons; they used it ceremonially, they used it in an addictive way. There's a group of Huron Indians in the northern part of the country that -- who have been found to have used very large quantities of tobacco smoked in pipes, and it's theorized that they had very large usage. So this is something that was present when the early European explorers came to the United -- to the -- to the New World and they discovered that the natives were using tobacco. And they took it back with them. They -- they were amused by this, some were, and others began to use it themselves.
And the third point, the Portugese explorers really are credited in some way for basically making this circle the globe within the period of a hundred years, which is very, very unusual for a product to be able to do that in such a short period of time in those -- from that -- in that century. They would take the seeds of tobacco from -- from one port or from the New World and take them with them and leave seeds. And then it basically circled the world. So tobacco use was something that -- that the European explorers found when they came here. They took it back with them, back to Europe as well as around the world.
The last person on the list here is Sir Walter Raleigh, who popularized pipe smoking back in the 17th century. And there's an etching that I could -- can recall of his servant getting ready to throw a pot of water on him because he was smoking his pipe; the servant thought he was on fire because it was an unusual thing to see someone smoking -- smoking tobacco.
The next one is kind of a continuation of this because as -- as tobacco began to be grown, it became a very important product. And the American colonies began to grow and export it. The colonies which were involved are the ones listed here, but tobacco can be grown in almost anyplace. Wisconsin used to be a very large tobacco-growing state. Still is. Tobacco can be grown in Canada, tobacco can be grown in a lot of different states. Though it was focused in the Carolinas, Virginia and the South, it can be grown in a lot of different places.
It was a major export product for us to Britain. And as I've mentioned here, a hundred million pounds in 19 -- in 1775 was a very large amount of tobacco. And that almost became a currency for the early colonies. The forms of tobacco, though, were pipes, snuff and chewing tobacco, not cigarettes. Cigarettes didn't really come around until much, much later.
The next one kind of shows the predominant form of tobacco use around the world at that time, which has to do with cigars in Spain, snuff and chewing tobacco in England, snuff in China.
THE COURT: Excuse me, doctor. Doctor, excuse me. Yes.
MR. BERNICK: Yes. I believe that the witness is now referring to an additional exhibit, 30084, I guess, and I don't know what Your Honor's preferred procedure is, but I don't believe the foundation has been laid for this exhibit with this witness, and I believe that this area exceeds the scope of the expertise that's been established with prior questioning, so I would object to the use of the exhibit and further request that counsel not display an exhibit until the court has determined it can be displayed to the jury.
MR. CIRESI: These are part of the same series of exhibits, Your Honor. They were individually numbered only to have an individual number on them, which we will identify at the end of his comment on this particular portion of this series of exhibits. And they're for illustrative purposes.
THE COURT: You may proceed.
MR. BERNICK: Just for clarification, Your Honor, is there -- I'm sorry, is there --
THE COURT: Counsel, your objection is overruled. You may proceed.
MR. BERNICK: Okay.
BY MR. CIRESI:
Q. Please proceed, doctor. You were talking about the types of -- or forms of tobacco that were used in different countries, which is on the next in this series of exhibits.
A. Correct.
Q. And it's 30084, for illustrative purposes only.
A. The types of tobacco that were used around the world became almost unique to some countries. Most of us have a recollection of some of the early Dutch portraits which would have a long-stem pipe, a small clay pipe that was used. So pipes were used there. Snuff in Scandinavia. And these are other forms of tobacco use in these countries at that time, 18th and 19th centuries.
Conspicuously absent from this are cigarettes because cigarettes didn't come until much later.
Q. Can you move to the next exhibit, doctor, for illustrative purposes. It's Exhibit 30085, which talks about the origin of cigarettes. And if you could briefly describe what's depicted on that exhibit.
A. There were several things that occurred in -- in the course of history that really made it possible to change the delivery system, if you will, from pipes and chewing tobacco and snuff and cigars, and one was a curing process that's mentioned here that was discovered accidentally. And there are various stories about how that was discovered, but basically there was a -- a heating -- heating of the tobacco that was hanging in a barn because some sawdust caught fire, and the heat rose through the barn making a -- a different leaf, it became called bright leaf, and it had a more acidic -- it was more acidic, had a higher carbohydrate content, and therefore was easier to inhale.
As you have higher pH in a tobacco product, it makes it harder to inhale it because when you get to a pH of eight or so, like in cigars or in pipe smoke, it's harder to inhale because it's harsh. So that was a process that was basically discovered -- discovered by accident.
And cigarettes began to be produced probably around the time of the Civil War, shortly thereafter, and -- but they were hand-rolled, and the main -- main tobacco that was used was called turkish tobacco, and they became a luxury item for people in the cultural centers of this country as well as in Europe, like in London and Paris, as well as New York and Philadelphia. Being hand-rolled, they were very expensive. And the factories that produced them were limited; there were only a few of those. And a good hand-roller, a person who could roll these things, could only roll a certain number in a day, around 2,000 cigarettes a day, so the product was expensive and it was really only used by people who could afford it.
Q. Could you move then to Exhibit 30085, continuing with regard to the origins of --
A. This is the second page of the same exhibit.
Q. Second page.
A. Yeah.
Q. Correct.
A. In the 1870s, as cigarettes became to be more popular, there were more cigarette factories or more cigarette companies, and there was a company called Alan and Ginter who wanted to have a mechanical rolling machine to be developed, and they offered a product and a man by the name of James Bonsack won the contest. And he had invented a machine that could produce and roll 120,000 cigarettes per day, which greatly increased the capacity or the potential capacity of factories to produce cigarettes. He actually offered this for sale, or the rights to it, back to Allan and Ginter, and they declined to buy the rights to the machine by saying, "Gee, we don't know what we'd do with all those cigarettes that would be produced. There's not a market for them. They would produce too many cigarettes for us to even be able to sell them all."
James Buchanan Duke, on the other hand, was a man who I'll talk a little bit more about in a moment, who -- his father, Washington Duke, had formed a tobacco company when he returned from the Civil War, and his son, James Buchanan Duke, who became basically the president and the driving force behind this company, recognized that the Bonsack machine and cigarettes were the future for the tobacco industry. He made a special arrangement with Bonsack to have the rights to this machine, and the arrangement went like this: He would be able to buy the machines always at a cheaper price than his competitors, so he was always able to -- to have the machines available to him cheaper than his competitors could.
Q. Could we go to Exhibit 30089, which is a -- I'm not sure how good that will come out.
Is that a drawing of the Bonsack cigarette machine?
A. That's correct. That's a -- that's from a patent of the machine that was patented by Bonsack. Pretty crude-looking device, but obviously worked.
Q. And the number off to the left there, 238,640, that would be the patent number in the United States Patent and Trademark Office; is that correct?
A. As far as I know, yes.
Q. Okay. We move on then to Exhibit 30087, the next slide in this overview of the tobacco industry.
A. And this has to do with kind of where I left off with Washington Duke, who returned from the Civil War, and one of the few things that was left on his farm that -- at the time in North Carolina was last year's tobacco crop. He decided to sell that as a way of getting started again after the war was over, and he and his son, as well as his other sons, then developed this company called Washington Duke & Sons, and they began to produce tobacco products, and one of the tobacco products was cigarettes.
So you can see in 1881 they produced 10 million cigarettes. The Bonsack machines were installed in 1884, and within a couple of years they were producing hundreds of millions of cigarettes. And as a result of that the price went down and became available to ordinary people rather than just available to the people who had more money that could afford them.
Q. Can you now direct your attention, doctor, to the next slide, which is 30088.
A. Under the leadership of James Buchanan Duke, he took the Duke Company to heights that no one ever dreamed would be possible. He took his lessons from other monopoly builders of the day, Rockefeller was one, but going into a area, producing this -- or marketing the cigarettes, lowering the price of those, driving the competition out and then buying the competition. And he did that very successfully. And in 1889 he had four of the companies drawn together with the Duke Company to form The American Tobacco Company, and that was the real first major tobacco company in this country, and it was led by James Buchanan Duke at the tender age of 32.
In 19 -- in 1898 he acquired the
R. J. Reynolds Tobacco Company, and
R. J. Reynolds was a company that mainly produced chewing tobacco.
R. J. Reynolds had come back, in a similar sort of situation, to -- to North Carolina after the Civil War and began producing chewing tobacco and began using burley tobacco in -- in that process. And you can -- it's understood that burley tobacco and the cellular size of it and the fact that you could add flavorings and things to burley tobacco would make the chewing tobacco more attractive.
Duke continued on with his building of his monopoly, and by 10 years later, after the formation of The American Tobacco Company, they basically had a monopoly on all tobacco products in this country. Over 90 percent of the cigarettes, over 80 percent of the snuff, over 60 percent of the plug tobacco and over -- almost 60 percent of the smoking tobacco, smoking tobacco like pipe tobacco. So they basically had a monopoly on the products in this country.
And he began to do the same thing in England that he had been able to do here, and that is to go into a market, lower the price, and begin to take over companies. And in that time the tobacco companies in England decided to ban together to form a new company called the Imperial Tobacco Company, which became the main tobacco company in England to confront Duke, and they would put up a stronger united front. And they made a deal between the two companies, between Imperial Tobacco Company and The American Tobacco Company, to basically divide up the market in the world. And it went like this: The American Tobacco Company would have rights to the United States, Imperial Tobacco Company would have the rights to the United Kingdom, and the new company called the British-American Tobacco Company would have the rights to the rest of the world. And so they basically divided up the world and moved forward.
Q. And can you go to the next slide of Exhibit 30088. What happened then in 1911?
A. Well there was a suit brought, and I think that was brought in 1907, that had to do with a -- an antitrust action against The American Tobacco Company because of this monopoly. It had attained a monopoly of tobacco products in this country, and they also acquired other companies like
R. J. Reynolds along the way. And the United States Supreme Court dissolved the Duke Trust in 1911, and out of that Duke -- out of that dissolution of the Duke trust came The American Tobacco Company,
R. J. Reynolds, Liggett & Myers, and
P. Lorillard. And -- and after that, then, these companies were able to go on their way outside of the Duke Trust, and
R. J. Reynolds Tobacco Company then developed what is considered to be the modern cigarette, the cigarette of this century, and it became known as Camels.
It is a blend -- or was a blend that was different than the other blends that had been available up to that time. Up until that time there was flue-cured tobacco and turkish tobacco blended together, if there was a blend, and what
R. J. Reynolds had learned with burley tobacco, through his work with smokeless tobacco or -- or -- or chewing tobacco, was he'd learned a lot about that and he made a new blend, which included all three, flue-cured, turkish, and now burley tobacco, and made it into what's now known as Camels, and that became the new cigarette.
The other two things on this slide have to do with the other companies. Philip Morris was -- was incorporated in the U.S. in 1919. And then the British-American Tobacco Company purchased Brown & Williamson, a tobacco company in Louisville, Kentucky, in 1927, which then displays the current players.
MR. CIRESI: Your Honor, I'd offer for illustrative purposes only Exhibits 3083, 3084, 30 -- I'm sorry, I misspoke. 30083, 30084, 30085, 30089, 30087, 30088.
MR. BERNICK: Your Honor, we've lodged a prior objection on grounds of foundations and the scope of this witness's expertise. I don't believe he's been qualified in some of the areas covered. However, they've already been shown to the jury, and therefore I'm not sure what the purpose of this additional proffer is.
THE COURT: They'll be received for illustrative purposes.
MR. CIRESI: Thank you, Your Honor.
BY MR. CIRESI:
Q. Doctor, can you direct your attention in the same volume, volume two, to Exhibits 19003 and 19004. And were those examples of the types of ads that were utilized by RJR when they launched the Camel cigarette?
A. They were.
Q. And again, this is part of the historical studying that you've done in order to be able to describe the history of smoking to your patients in treating them at the Mayo Clinic; is that right?
A. Correct.
MR. CIRESI: For illustrative purposes, Your Honor, we'd offer 19003 and 19004.
MR. BERNICK: Your Honor, these, as I understand it, were advertisements that were not listed in the disclosure that was made in connection with this witness's expert reports, both of these, so I believe if that is so, that is what I'm informed, and we would object on those grounds.
Apart from that, I believe that these documents relate to the same objection I had previously, which I believe Your Honor has overruled, and I understand that ruling.
MR. CIRESI: My understanding is they were produced, Your Honor. They were identified, I should say.
THE COURT: Well they'll be received at this time unless -- subject to your being able to show that they were not identified.
MR. BERNICK: Yes, sir.
MR. CIRESI: Thank you.
BY MR. CIRESI:
Q. Describe what we have here, which is Exhibit 19003.
A. Well there were two parts to the Camel story, one was the new blend, the new cigarette, and the other was the -- the advertising and marketing, which was the most extensive that had been available up until that time. The -- the first ad has to do with "The Camels are coming," and if you look at this ad you can tell that we're talking about cigarettes, we're talking about the Camels are coming. So this is kind of the entry ad into identifying this as a new product. And there was an extensive campaign throughout the country to -- to get this word out.
Then the next one, which was -- must be 19004 --
Q. 004.
A. -- really has to do with a display that was made to potential store people that might put these types of ads, and so you can see down the left-hand corner, "Camel cigarettes are here." So it kind of went "The camels are coming. The Camels are coming," and now "The Camels are here." So this is a very sophisticated and at that time unheard of national sort of campaign to promote this new cigarette.
Q. And doctor, can you direct your attention to Exhibit 30086, and before it's put up there, is this a chart that you prepared showing early cigarette consumption in the United States?
A. That's correct.
MR. CIRESI: Your Honor, we'd offer this for illustrative purposes, 30086.
MR. BERNICK: I have the same objection, Your Honor, which I note the court has already ruled upon.
THE COURT: It will be received for illustrative purposes.
A. Well this just tells the whole story as far as numbers are concerned, because, as I said earlier, cigarettes really were not a part of our heritage. My great grandparents were not really part of this. My grandparents were because they were born in the 1890s, but my great grandparents really were not part of the cigarettes that we know of the late 19th century and the 20th century. And these are just volumes of production.
You have already seen in 1885, after the Bonsack machines were put on line at the Duke factories in Durham, the rates went up very high. By 1905 there were almost four billion cigarettes consumed in the United States. And then the year of the Camel, in 1913, 1914 and 1915, you can see there was a virtual explosion of cigarette consumption in this country. And it kept on going up until the mid-1960s when several hundred billion cigarettes were consumed in the United States, whereas before -- as little as, you know, 65 years before that, fewer than four billion cigarettes were consumed in our country.
So this really is a 20th century phenomenon that has the potential to carry on into the 21st and 22nd century.
Q. And doctor, have you also, as part of your study of the addictive nature of nicotine, and in order to treat physicians -- excuse me, patients, have you examined the cancer lung deaths and the prevalence of those and incidence of those over the time of the 19th or 20th century?
A. I have.
Q. Okay. Can you direct your attention to Exhibit 30211 --
A. Okay.
Q. -- and 30212.
Do these two charts show the various cancer rates -- and this is from the Cancer Journal for Clinicians, Exhibit 30211, and 30212 is also from the Cancer Journal for Clinicians -- showing age-adjusted cancer death rates for males?
A. Correct.
MR. CIRESI: Your Honor, we'd offer 30211 and 30212 for illustrative purposes.
MR. BERNICK: I have no objection to those, Your Honor.
THE COURT: Court will receive 30211 and 30212.
BY MR. CIRESI:
Q. If we look first at 30211, doctor, and this is the age-adjusted death rates for females in the United States, 1930 to 1993, can you tell us what is being depicted on this chart?
A. Well I'm going to try to see if I can do this from here, but I think I can.
So this is 1930, and it goes across this way to 1990 over here. This one is breast cancer, the one in the middle. This one is lung cancer. Lung cancer was a very rare form of disease prior to the year 1900. Lung cancer didn't occur very often. Then as you can see, by the mid-'50s and into the '60s and '70s, lung cancer became the most common cause of cancer death in women. It surpassed breast cancer as the leading cause of cancer death in women.
And this number is likely to continue to go up. I've been following this over the last 15 years with the same display, and not too many years ago it was down here below breast cancer. Now that's not the incidence of cancer. Breast cancer is still more common in women. But as far as a cause of cancer death, it is second to lung cancer as a cause of cancer death.
The next one has to do with men, which is the same display, and as you might imagine the same thing is true in men. This is lung cancer. It's been the leading cause of cancer death in men since the 1950s, and there's not anything that's even a close second. This represents in this day and time over 30 percent of all cancer deaths in men. Thirty percent.
Prostate cancer is -- let's see where prostate cancer is. Prostate cancer is the dark line, this one. And we hear a lot about prostate cancer, we hear a lot about breast cancer, but lung cancer is the leading death in men and has been for all of my lifetime.
So these two -- these two numbers as far as cancer deaths are concerned account to over 120,000 Americans dying each year of lung cancer, a disease that was rare and practically nonexistent at the turn of the century. And it pales, makes these other ones pale in comparison as far as the frequency of death. This accounts for over a quarter of all of the deaths due to tobacco-related diseases in our country, of which there's over 420,000 Americans each die -- day dying of tobacco-related disease, so this accounts for over a fourth of those.
To give you an example of how many people 420,000 American's are, that's the equivalent of three fully-loaded 747s crashing every day 365 days a year with no survivors. And this is a quarter of that total number. A disease that was rare at the beginning of the century.
THE COURT: Counsel, I think we'll recess at this time. We'll reconvene at 2:00 o'clock.
THE CLERK: Court stands in recess.
(Recess taken.)
AFTERNOON SESSION.
THE CLERK: All rise. Court is again in session.
(Jury enters courtroom.)
THE CLERK: Please be seated.
MR. CIRESI: Thank you, Your Honor.
BY MR. CIRESI:
Q. Good afternoon, doctor.
A. Good afternoon.
Q. We've been talking about nicotine. What is nicotine?
A. Nicotine is a substance called an alkaloid. An alkaloid is a nitrogen-containing organic base that's physiologically active. It's like -- other alkaloids are cocaine and opiates as well as nicotine, and quinine is an alkaloid.
Q. Is it toxic?
A. It can be. In fact one of the uses of nicotine is as an insecticide. We have -- I actually have a can of Black Flag nicotine sulfate, which is used to kill insects with. So it can be toxic to animals or -- or to insects or to humans.
Q. Is it pharmacologically active?
A. Yes, it is.
Q. And can you describe what you mean by that?
A. Well "pharmacologically active" means that it has an effect on the -- the person. It can have an effect on the blood pressure or the pulse rate, those would be two of the pharmacologic actions that nicotine can have.
Q. Does it have any effect on the central nervous system?
A. Yes, it does. It's -- a stimulant basically is a -- is a class of drugs and it has that -- that kind of effect. And most smokers notice that, as a stimulant effect, it might be used to kind of keep you awake when -- when you get fatigued. So it has that kind of effect.
Q. Doctor, did you ascertain from the defendants' documents and your review of those documents whether or not the defendants considered nicotine a drug?
A. Yes, they did.
MR. BERNICK: Your Honor, I have an objection to questions that pertain to our documents at this point. I don't believe an adequate foundation has been laid to establish that this witness is an expert in reconstruction of corporate history and corporate knowledge. I have some questions I'd like to ask him in order to lay a further ground work for that objection.
THE COURT: Objection is overruled. You may respond to the question.
MR. BERNICK: Thank you.
A. Repeat the question.
Q. Yes.
A. I forgot it.
Q. Did you ascertain from the defendants' documents whether or not the defendants considered nicotine to be a drug?
A. Yes, I did.
Q. And --
A. And they did.
Q. All right. Can you direct your attention, please, to volume one and to document number 10539. They are in chronological order, doctor.
A. I got it, yup.
February 19, 1969?
Q. Correct.
Doctor, this is a document dated February 19th, 1969, a Philip Morris document from William
L. Dunn to Dr. H. Wakeham and is marked confidential. Is this one of the Philip Morris documents that you have reviewed?
A. It is.
MR. CIRESI: Your Honor, we would offer Exhibit 10539.
MR. BERNICK: Your Honor, we do not have an objection to the document itself, but this document does bring to bear the same objection that I lodged to a previous question, and I have the same objection to this line of examination. I don't want to keep on interrupting the proceedings unnecessarily, and if Your Honor would accommodate this, maybe we can just have a continuing objection to questions that pertain to historical analysis on the grounds that there's not a adequate foundation for it and on the grounds that it's beyond this witness's established expertise, so I don't have to keep reiterating the same objection.
THE COURT: Well counsel, I don't know what all your objections might be in the future, but I have ruled that he has sufficient expertise and it's proper testimony at this time.
MR. BERNICK: Thank you.
BY MR. CIRESI:
Q. This is one of the documents you reviewed; correct?
A. It is.
Q. Okay. Put it up.
MR. CIRESI: We'd offer that exhibit then, Your Honor.
THE COURT: That exhibit will be received.
BY MR. CIRESI:
Q. Now some of these are older documents, and this one comes from '69, so they're difficult to read. I'm going to direct your attention to the third paragraph, and it reads as follows: "I would be more cautious in using the pharmic-medical model -- do we really want to tout cigarette smoke as a drug? It is, of course, but there are dangerous FDA implications to having such conceptualization go beyond these walls."
Now doctor, this is 1969. Was the FDA regulating cigarettes?
A. No, they were not.
Q. Were they regulating them at the time this lawsuit was filed in 1994?
A. Not to my knowledge.
Q. Is this document of Philip Morris an example of the type of documents that you reviewed of the defendants with respect to their knowledge that nicotine was a drug?
A. It is representative, and there were literally thousands of pages of documents that I've reviewed over the last year and a half or so, so this is fairly consistent with the other -- other documents that I've seen.
Q. To your knowledge, has Philip Morris ever publicly stated that they held an opinion as early as 1969 that nicotine was a drug?
A. Not to my knowledge.
MR. BERNICK: Object to the foundation, Your Honor.
THE COURT: I think you need to rephrase that question, counsel.
BY MR. CIRESI:
Q. To your knowledge, has Philip Morris ever admitted publicly, based on your experience, that nicotine was a drug?
A. Not to my knowledge.
MR. BERNICK: Same -- same objection and the same question, Your Honor.
THE COURT: You may answer that.
A. Not to my knowledge.
Q. Doctor, can you direct your attention to Exhibit 18089, which is in volume two.
A. Give me the number again.
Q. 18089.
A. Okay.
Q. This is a document entitled "Motives and Incentives in Cigarette Smoking," William
L. Dunn, Jr., Philip Morris Research Center, Richmond, Virginia, again marked confidential. Is this a document that you reviewed in order to prepare yourself for testimony here?
A. It is.
Q. And is this one of the documents that forms the basis of your opinions that you're rendering in this case?
A. Yes, it is.
Q. And is this document representative of other documents that you reviewed of the defendants in the thousands of pages that you reviewed?
A. It is.
MR. CIRESI: Your Honor, we would offer Exhibit 18089.
MR. BERNICK: No objection, Your Honor.
THE COURT: Court will receive 18089.
BY MR. CIRESI:
Q. First of all, doctor, we see at the top the title, "Motives and Incentives in Cigarette Smoking," and above that to the right is a confidential stamp, and the author is William
L. Dunn, Jr., Philip Morris Research Center, Richmond, Virginia.
Do you recall that this document relates to a conference that was held on an island in the Caribbean waters?
A. That's correct. 1972.
Q. Okay. And can you direct your attention to page three of that document. Again this is document 18089.
If you look at the second paragraph there, there's a reference to who the conference was called by.
A. The Council for Tobacco Research, U.S.A.
Q. And can you direct your attention to the paragraph right below that starting with "Most of the conferees would agree...."
A. Uh-huh.
Q. Do you see that?
"Most of the conferees would agree with this proposition. The primary incentive for cigarette smoking is the immediate salutory effect of inhaled smoke on body function."
And doctor, based on this document, what was being discussed there in in that paragraph?
A. They were talking about the behavior of smoking, and basically we're talking about the cigarette as a nicotine-delivery device.
Q. Okay. Can you direct your attention to page five of that document, please. I'd like to start at the top with the following paragraph: "Why then is there not a market for nicotine per se, to be eaten, sucked, drunk, injected, inserted or inhaled as a pure aerosol? The answer, and I feel quite strongly about this, is that the cigarette is in fact among the most awe-inspiring examples of the ingenuity of man. Let me explain my conviction.
"The cigarette should be conceived not as a product but as a package. The product is nicotine."
Now doctor, in this document does Mr. Dunn talk about the pharmacologic effect of nicotine on the body?
A. He talks about basically the -- the cigarette as being a dose dispenser for nicotine and the nicotine -- and the cigarettes being a delivery device for nicotine.
Q. To your knowledge, did Philip Morris ever publicly state that at any time up to 1994?
A. Not to my knowledge.
MR. BERNICK: Your Honor, the same objection as before, lack of foundation.
THE COURT: You may answer that.
A. Not to my knowledge.
Q. Do you know if Philip Morris, up through 1994, ever said think of the cigarette pack as a storage container for a day's supply of nicotine?
A. Not to my knowledge.
MR. BERNICK: Note my same objection, Your Honor.
THE COURT: Same ruling.
Q. Did Philip Morris ever publicly state think of the cigarette as a dispenser of a dose unit of nicotine?
A. Not to my knowledge.
MR. BERNICK: Same objection, Your Honor.
THE COURT: Same ruling.
Q. Can you turn over to page six. At the top of the page Mr. Dunn states, "Think of a puff of smoke as the vehicle of nicotine." And then next to number two he states, "The smoker has wide latitude in further calibration: puff volume, puff interval, depth and duration of inhalation. We have recorded wide variability in intake among smokers. Among a group of a pack-a-day smokers, some will take in less than the average half-pack smoker, some will take in more than the average two-a-day-pack smoker -- two-pack-a-day smoker." And then finally right below number five, "Smoke is beyond question the most optimized vehicle of nicotine and the cigarette the most optimized dispenser of smoke."
What is being addressed there in terms of calibration of a smoker with regard to nicotine?
A. Well he's basically talking about the variability between smokers. Some smokers will smoke a cigarette more aggressively than others, take deeper, deeper inhalations, hold their breath longer, so he's talking about the variability. But he's also talking about kind of the threshold that a person has when they smoke a cigarette, having to receive the dose that does the things in the central nervous system, in the brain, to release the neurotransmitters that causes the effects, the pleasure and the reward effects, and those will be different from one person to the next. So this is basically describing how a person might adjust their dose of nicotine by smoking cigarettes, much like a diabetic would adjust their dose of insulin based on how they felt or what their blood sugar might have been.
Q. Doctor, to your knowledge, have any of the defendants ever to this day -- strike that -- ever up until 1994, ever stated that nicotine was a drug and that the cigarette was a dispenser of that drug?
A. Not to my knowledge.
MR. BERNICK: Again, Your Honor, the same objection on which the court has previously ruled.
THE COURT: Okay.
Q. Can you direct your attention now, doctor, to Exhibit 12408, which again is back in volume one of the two volumes in front of you.
Do you have it?
A. Got it. Yup.
Q. This is an RJR confidential document dated April 14th, 1972, written by Claude
E. Teague, Jr. Is this one of the documents that you've reviewed for purposes of giving your testimony here?
A. It is.
Q. Is it representative of the documents that you reviewed of the defendants with respect to the issue of nicotine as a drug?
A. Yes, it is.
MR. CIRESI: Your Honor, we would offer Exhibit 12408.
MR. BERNICK: Your Honor, I believe that this is a -- this is a document that was created by Dr. Teague not in the course of his activities at Reynolds but as part of the course that he took at a university, and it obviously, therefore, would reflect the content of what had taken place at the university which was not an ordinary-course-of-business record. For that reason we would object.
THE COURT: The objection is overruled. The court will receive into evidence 12408.
BY MR. CIRESI:
Q. Now on the cover page it says RJR; correct?
A. That's right.
Q. And it says confidential?
A. Correct.
Q. And along the side there it says "PRODUCED BY RJRTC," which is
R. J. Reynolds Tobacco Company. Do you see that?
A. I see it.
Q. And it says it's "PRODUCED IN HUMPHREY," which is this litigation; correct?
A. Yes.
Q. Okay. Now if you go to the very last page, we'll see Mr. Claude E. Teague, Jr.'s signature and the date of April 14th, 1992. Do you see that, sir?
A. 1972.
Q. I'm sorry, 1972. Thank you.
If you direct your attention, doctor, to the first page of text, it says, "In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized and stylized segment of the pharmaceutical industry. Tobacco products, uniquely, contain and deliver nicotine, a potent drug with a variety of physiological effects. Related alkaloids, and probably other compounds with desired physiological effects, are also present in tobacco and/or its smoke."
Let me just stop there. With regard to that statement, are you aware of whether RJR or any of the defendants ever made such a statement up to 1994, to your knowledge?
A. That they thought of themselves as part of the pharmaceutical industry?
Q. Correct.
A. I'm not aware of any such statement.
MR. BERNICK: Your Honor, it is the same objection. I know Your Honor has ruled, and again I'd be more than happy to -- or I'd appreciate if the court would give us a continuous objection so that I can keep my seat and we can proceed.
THE COURT: Okay. If the question is similar, you'll get the same response from the court. If they start getting different, counsel, you'll have to stand up and object.
MR. BERNICK: I'll be sure to do that.
Thank you, Your Honor.
THE COURT: All right.
BY MR. CIRESI:
Q. Now in your earlier testimony you said that you learned new information about what the defendants knew at given points in time as a result of your review of the documents. Do you recall that testimony?
A. I do, yes.
Q. The last three documents that we've looked at, is that the type of information that you discovered that the defendants knew at various points in time which had not been made public?
A. That's -- to the best of my knowledge, that's correct.
Q. Let me read on in this first paragraph. "Nicotine is known to be a habit forming alkaloid, hence the confirmed user of tobacco products is primarily seeking the physiological satisfaction derived from nicotine -- and perhaps other active compounds. His choice of product and pattern of usage are primarily determined by his individual nicotine dosage requirements and secondarily by a variety of other considerations including flavor, irritancy of the product, social patterns and needs, physical and manipulative gratifictions, convenience, cost, health considerations and the like."
Now sir, up to and including August of 1994, had any of these defendants ever made any such type statements publicly, to your knowledge?
A. Not to my knowledge.
Q. Direct your attention, then, doctor, to Exhibit 10683. This is again in volume one.
A. Okay.
Q. This is a memorandum by a
C. C. Greig, G-r-e-i-g, of BATCo, Ltd. Is this one of the documents that you referred to and reviewed, doctor?
A. It is.
Q. Is this doctor --
Is this document representative of the other documents of the defendants that you reviewed regarding the subject matter of nicotine and its addictiveness as a drug?
A. That's correct.
MR. CIRESI: Your Honor, we would offer Exhibit 10683.
MR. BERNICK: No objection, Your Honor.
THE COURT: Court will receive Exhibit 10683.
BY MR. CIRESI:
Q. And turn to the first page of the text. I think we'll get a little better -- there.
Direct your attention to the top, doctor. You'll see there it says "STRUCTURED CREATIVITY GROUP, THOUGHTS BY
C. C. GREIG -- R&D, SOUTHAMPTON, MARKETING SCENARIO.
"Before starting on any future scenario, let us look at what we are currently selling, where and how it has developed.
"A cigarette as a drug administration for public use has very significant advantages. One, speed. Within 10 seconds of starting to smoke, nicotine is available in the brain. Before this, impact is available giving an instant catch or hit, signifying to the user that the cigarette is active. Flavor, also, is immediately perceivable to add to the sensation.
"Other drugs such as marijuana, amphetamines, and alcohol are slower and may be mood dependent."
Now is this statement by Mr. Greig of B.A.T. Company Ltd. with regard to the cigarette as a drug-administration system something that BATCo, to your knowledge, ever publicly stated at any time prior to August of 1994?
A. Not to my knowledge.
Q. Doctor, I'd like to address your attention now to Exhibit 14145, which has been referred to as the Frank Statement.
A. Okay.
MR. CIRESI: Your Honor, we'd offer that exhibit.
MR. BERNICK: No objection, Your Honor.
THE COURT: Court will receive 14145.
BY MR. CIRESI:
Q. In the left-hand margin, doctor, you'll be able to find the statements that "We accept an interest in people's health...." Do you see that?
A. No, I don't see it. Oh, down at the bottom, yes.
Q. Down at the bottom, right about here.
A. Okay, I got you.
Q. "We accept an interest in people's health as a basic responsibility, paramount to every other consideration in our business.
"We believe the products we make are not injurious to health.
"We always have and always will cooperate closely with those whose task it is to safeguard the public health."
Now with respect to those statements made by the tobacco industry on January 4th, 1954, what if any significance are those to you, doctor, as a physician?
MR. CORRIGAN: Your Honor, objection. Now the reason for my objection -- excuse me, Your Honor, it's difficult to get up to the podium -- is Mr. Ciresi's reference to "tobacco industry." Signatories to the statement do not constitute the tobacco industry.
THE COURT: Rephrase your question, counsel.
MR. CIRESI: Your Honor, I'm sorry, I didn't hear the last part of it.
THE COURT: You made reference to the tobacco industry, and he indicated that the signatories to the Frank Statement are not all inclusive. You may want to rephrase your question.
MR. CIRESI: Let me rephrase it and take out "tobacco industry" at this point.
BY MR. CIRESI:
Q. With regard to the undersigned statement, who are The American Tobacco Company, Brown & Williamson Tobacco Company,
P. Lorillard Company, Philip Morris and Company, Ltd.,
R. J. Reynolds Tobacco Company, with regard to those defendants who made these representations to the public, what significance, if any, are those statements to you, doctor?
A. I think it has to do with expectations. I think if an industry were to say that they accept an interest in the people's health as a basic responsibility and use the word "paramount," which to me means the very peak or the very pinnacle or the very top of expectations, to the exclusion of every other consideration in our business, to me that means that the consumer of that product should be assured that the product is safe to use, and that if they were to find out something that was bad about that product they would tell the public, the consumer, the medical community, and everyone else that had to do with these kind of -- of diseases that -- that this product happens to cause.
I think that what they said was that they intended to do that, and I don't think that they did that. They did not live up to their promise.
MR. BERNICK: Your Honor, I move to strike the last portion of the answer, I don't believe it was responsive and I don't believe there's a foundation for it, and I think it invades the province of the jury.
THE COURT: The last sentence was non-responsive. It will be stricken.
BY MR. CIRESI:
Q. Doctor, do you know how broad the dissemination of this undertaking of a special responsibility was based on your review of the documents?
A. It was very broad. There's another document that said how many newspapers throughout the country. I think it went to every -- every newspaper -- or every city that had a population of about 50,000 people. So it was very broad.
Q. Can you direct your attention to Exhibit 14127 in volume two of the two volumes in front of you.
A. I have it.
Q. This is an agenda for the Tobacco Industry Research Committee meeting of January 18th, 1954. Have you reviewed this document, doctor?
A. I have, yes.
Q. Does it form part of the basis of your opinions in this case?
A. It does.
MR. CIRESI: Your Honor, we would offer Exhibit 14127.
MR. BERNICK: No objection, Your Honor.