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In fact, that's an area that has received a lot

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Abstract

In fact, that's an area that has received a lot of attention from the NIH, and I think people are spending more effort on interracial and ethnic differences.

Fields

Named Organization
American Cancer Society
American College of Cardiology
American Heart Association (Voluntary health organization that focuses on cardiac health)
Voluntary health organization that focuses on cardiac health and stroke. AHA occasionally teams with tobacco retailers to engage in promotions/fund-raisers (see http://www.smokefree.net/doc-alert/messages/247136.html and http://www.rawbw.com/~jpk/stand/Pictures.html).
American Journal of Public Health (periodical)
Americans for Nonsmokers' Rights (Anti tobacco organization)
Concerned with clean indoor air.
Beverly Hills Restaurant Association (Industry front group)
Set up c. 1988 by the Tobacco Institute to clandestinely fight a local smoking restriction (TI00380927-0949, Pag. -0946).
California Air Resources Board
Californians for Nonsmokers' Rights (Americans for Nonsmokers rights precursor)
Precursor organization to Americans for Nonsmokers Rights
Center for Indoor Air Research (CIAR) (Industry formed/funded air research organization)
Nonprofit organization funded by the tobacco industry. CIAR was formed in March 1988 by tobacco companies "to sponsor "high-quality research on indoor air issues and to facilitate communication of research findings to the broad scientific community."
Congressional Research Service (Criticized 1993 EPA ETS report)
Criticized EPA's January 1993 report designating passive smoke as a carcinogen
Environmental Protection Agency (EPA)
Federal Register (publication)
McDonald's Corp.
Ministry of Health and Welfare (Japan)
National Institutes of Health (NIH)
National Licensed Beverage Association
National Research Council
New England Journal of Medicine
Nonsmokers Rights (California anti-smoking organization created by Stanton Glan)
Occupational Safety and Health Administration (OSHA)
Price Waterhouse (Accounting firm)
R.J. Reynolds Corporation (second tier subsidiary of RJR Industries)
Tobacco Institute (Industry Trade Association)
The purpose of the Institute was to defeat legislation unfavorable to the industry, put a positive spin on the tobacco industry, bolster the industry's credibility with legislators and the public, and help maintain the controversy over "the primary issue" (the health issue).
*University of California (use specific branch)
University of California San Francisco
Washington Technical Information Group, Inc.
World Conference on Smoking and Health
World Health Organization (Concerned with global public health)
International organization concered with public health worldwide
Named Person
Alsop, L. Susan
Barr, Glen
Bero, Lisa A., Ph.D. (Epidemiologist, UC San Francisco)
Feinstein, Diane
Garfinkle, Larry
Glantz, Stanton
Grossman, Ted
Lee, Peter N. (TAC Biostatistician)
Frequently funded by the tobacco industry to criticize and discount published and epidemiological studies that linked between tobacco smoking and health damage.
*LeVois, Maurice (use LeVois, Maurice Emile, Ph.D.) (industry consultant)
1996 submitted comments to EPA, worked with PN Lee on IARC rebuttal.
Lowe, Michael
Mahler, Sara
Mayor, Francisco
Michaels, Robert
Parmley, Bill
Penn, Arthur
Pfeffer, William, Jr.
Rossi, Bob
Rossi, Robert
Samet, Jonathan
Siegel, Michael B., M.D. (Epidemiologist, Boston U, School of Public Health, Anti-Toba)
Toon, Michael
Wald, Nicholas J., Ph.D. (Colleague of Sir Richard Doll, coauthor with Law of secondha)
Professor of Preventive Medicine, Wolfson Institute of London, Colleague of Sir Richard Doll, coauthor with Law of secondhand smoke metaanalysis
Warner, Kenneth E., Ph.D (Plaintiff's expert, health care costs)
Plaintiff
Woods, Rosemarie
Wynder, Ernest
Master ID
TI10111465-1821
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 457 is very ligtle independent cardiovascular epidemiologyon those groups in general. In fact, that's an area that has received a lot of attention from the NIH, and I think people are spending more effort on interracial and ethnic differences. As a general rule, though, when you look at the major risk factors for heart disease, the importance of those risk factors seem to be pretty much, to my understanding, independent of ethnicity, although there are some subgroups, for example, that are more prone to hypertension, such as blacks, but the effect of the hypertension on the heart, where it doesn't seem to be different in blacks than whites. So I wouldn't see the question that you're raising as a particularly strong limitation on the studies. It would be nice if we could do the perfect study and have perfect stratification by everything imaginable, but I don't think you'll ever find a study that you can't find something to criticize. MR. SIRRIDGE: You're familiar with the migrant studies and how heart disease, risk and risk factors change from Asian -- DR. GLANTZ: Which studies? MR. SIRRIDGE: Migrant. It's a type of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1644
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1 2 3 4 5 6 7 8 .9 i0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 epidemiologic study-- DR. GLANTZ : MR. SIRRIDGE : 458 Yes. Yes. -- where people move to different places and then their rates are compared against those of them who stayed in countries. There have been a number of studies which have measured Japan and places in the east with Hawaii and also with California, of all places. There has been a gradation of rates with a much higher risk for people who have moved here, suggesting the power and influence of traditional western risk factors. Is that true? DR. GLANTZ: I'm generally familiar with those studies from talking to colleagues about them and reading about them in the press. I wouldn't purport to be an expert on them. My understanding from this sort of general scientific knowledge is that the main changes that seem to account for those things are changes in diet, and again, no one is saying that diet isn't one of the risk factors for heart disease. It's important, I think, though, when you look at the ETS data, that they fact that we find reasonably consistent risks around the world, that, to me, is evidence that, again, the effects of ETS exist independent of those BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1645
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15~ 16 17 18 19 2O 21 22 23 24 25 459 changes. MR. SIRRIDGE: Doctor, isn't it also true the there are problems comparing epidemiologic studies on heart disease from different countries? DR. GLANTZ: That's such a vague statement. MR. SIRRIDGE: All right. Would you agree with this statement: "The problem of comparability of epidemiologic data across different countries where racial ethnic groups is evident for cardiovascular diseases." DR. GLANTZ: Who said that? MR. SIRRIDGE: Anthony Padednick, Department of Community and Preventive Medicines, University of New York Stoneybrook. It's a chapter in a book he wrote in 1989, called "Racial and Ethnic Differences in Disease". DR. GLANTZ: Well, I mean, I'm not familiar with that~book and can't comment on it. I think that, as a general point, one needs to consider those differences when thinking about the studies, and I have, in my analysis of these studies. Another thing that I think speaks directly to this, and I'm sure Dr. Wells will address is, is when he did an analysis of the studies and separated the U.S. studies from the non-U.S, studies, you get quite comparable results, and also when you look at studies -- better studies -- which control for more of the potential confounding variables, you BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1646
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 460 get highe~ risks than when you don't. So the confounding, which we've heard so much about in the cross examination so far, if anything, is probably reducing the estimated risks. I think, while as a general statement, that quote you read perhaps is true. I think, in terms of ETS and heart disease it's not a problem. MR. SIRRIDGE: My point here, poctor, is that the ETS studies are from all over the world. They control for very few of the traditional major risk factors, and the relative risks seem too high to be plausible according to commentators of that evidence. DR. GLANTZ: I don't agree with that statement. I mean, I can speak to -- I mean, that's not an accurate statement. MR. SIRRIDGE: Are you familiar with the report by the Congressional Research Service with respect to that? DR. GLANTZ: Yes. MR. SIRRIDGE: I'm sure Mr. Repace gave you a copy of it, didn't he? DR. GLANTZ: No. I have a copy of it, but I got it from -- I don't even know who gave it to me -- MR. SIRRIDGE: But you've discussed this -- DR. GLANTZ: -- who it was -- MR. SIRRIDGE: -- you've discussed it with BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1647
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 '16 17 18 19 2O 21 22 23 24 25 461 Mr. Repac%? DR. GLANTZ: I don't think so, actually. I don't recall. I've discussed it with several people. I don't think I've talked to him about it. I'll be happy to -- I mean, it's a piece of trash. First of all, if I could quote from it -- JUDGE VITTONE: Dr. Glantz. DR. GLANTZ: Oh, okay. I'm sorry. MR. SIRRIDGE: You would like a question? JUDGE VITTONE: Yes. Ask it. DR. GLANTZ: Well, he's been making statements rather than asking questions. JUDGE VITTONE: Well, let me worry about that. DR. GLANTZ: Okay. JUDGE VITTONE: Okay. Now, do you have a question, Mr. Sirridge? MR. SIRRIDGE: I do, indeed. I'd like to read you a statement from the Congressional Research Service. DR. GLANTZ: Yes. MR. SIRRIDGE: You probably have it in front of your too. DR. GLANTZ: Yes, I've just gotten it. MR. SIRRIDGE: "The most likely explanation of these large risks" -- BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1648
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 462 . DR. GLANTZ: Where -- where -- MR. SIRRIDGE: I'm sorry. From page 6 of the CRS, dated March 23rd, 1984. Your paper is cited, in fact, in the footnotes there. "The most likely explanation of these large risks from passive smoking, epidemiological studies for heart disease, is the absence of control for other factors. There are many important causes of heart disease (for example, diet, lack of exercise, lack of preventive health care) that may be engaged in by smokers. That is, there is much evidence that smokers tend to be less concerned about health risks in general. In general, studies do not and perhaps cannot control for many of these factors. If smokers' wives share in these behaviors, the relationships found in the epidemiologic studies are spurious." Did you consider that statement in reaching your conclusions for the 0SHApanel? DR. GLANTZ: Actually, I just realized that I don't have that document here. Do you have a copy I could read, before commenting on it? There were two reports, and I brought the one on economics rather than the one you're quoting from. MR. SIRRIDGE: DR. GLANTZ: MR. SIRRIDGE: I have one copy, is all I have. If I could just -- There's another one from September BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI 1011-1649
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 13th. DR. GLANTZ: MR. SIRRIDGE: DR. GLANTZ: but I want to be accurate. MR. SIRRIDGE: Okay. DR. GLANTZ: I'm sorry. thing. question. it. 463 But I'll -- Certainly, I'll let you read that. Yes. I'm not trying to be difficult I brought the wrong JUDGE VITTONE: [Pause.] JUDGE VITTONE: That's okay. Let's hear the question first. DR. GLANTZ: Yes. I've forgotten. MR. SIRRIDGE: I've forgotten the precise JUDGE VITTONE: Yes. That's why I'd like to have MR. SIRRIDGE: Okay. JUDGE VITTONE: Okay. MR. SIRRIDGE: The question is, Doctor, this appears to be a statement by some analysts who have reviewed the evidence and have an understanding of the mechanisms and the risk factors associated with heart disease. True? DR. GLANTZ: No. And the reason for that, and the reason for -- apparently, there is yet a third Congressional Service document because I have seen the one BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1650
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5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 464 that you had, in which the authors point out that they are economists, not biomedical scientists, and really aren't competent to comment on the biological evidence. I found that report a remarkably irresponsible document. I mean, I would never write a paper for publication that said I'm not competent to make these statements, which, if I could have found the correct document, and I will provide to the record if need be. THe other thing, and the very, very fundamental flaw that exists in the CRS study is, it presumes a threshold for both lung cancer and heart disease, and there is no evidence accepted by the general scientific community that the threshold effect exists. ! think, first of all, the authors of that report, by their own admission, were not competent to write it.. Secondly, the assumptions they made are at great variance with established scientific view. Third, I checked about this and asked what kind of peer review did these documents get before they were released, and the answer was none. So I think that document is an appalling document. It's an embarrassing document. I had previously thought the Congressional Research Service did good work, and I hope that that's an exception to the rule. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1651
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 15 16 17 18 19 2O 21 22 23 24 25 465 MR. SIRRIDGE: We' ll let others decide whether it's an exception, whether it's accurate. opinion. DR. GLANTZ : MR. SIRRIDGE : DR. GLANTZ : That's true. I'm entitled to my Absolutely. Dr. Glantz, you mentioned this morning that -- in fact, I was interested in your view that the relative risk for environmental tobacco smoke and heart disease could be i0. DR. GLANTZ: The data are -- if you look at, I think it was the Garland study done and not a terribly big one, from a statistical point of view, the relative risk could be anywhere in that 95 percent confidence interval with equal probability. I was not saying that I thought it was 10. I was just making a statistical statement based on that one study. If you look at the pooled estimate, the 95 percent confidence intervals are, in fact, quite narrow. They're about plus or minus .l, or probably even a little less than that, so I do not think the relative risk is MR. SIRRIDGE: Was the Garland ~tudy the one where they made the huge mathematical error? DR. GLANTZ: No. The Garland study, there was a typographical error in the paper, which Garlan subsequently published an erratumm on. There was not a mathematical BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-18~-52
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1 2 3 4 5 6 7 8 .9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 466 error in their work. I actually, when people started claiming that, called Garland and asked him about it, and he sent me a copy of the erratum which had already been published. I believe they interpolated two numbers or printed the log instead of the actual numbers, but the analysis was correct. MR. SIRRIDGE: And the risk went from 14.7 down to 2.7? Is that your memory? DR. GLANTZ: The correct result -- the result in Garland's paper, as published with the erratum, had the correct number. Me did not change what he said the risk was. What they did was corrected a typo. The analysis that was done in that paper was done correctly. MR. SIRRIDGE: What do you think the risk is, if it's ~ot I0 -- you said you didn't think it was 10? DR. GLANTZ: I think it's around 1.3 -- 1.2 to 1.4, somewhere in there. MR. SIRRIDGE: Well, Doctor, haven't there been comments made by qualified analysts and scientists in the ETS area that even that risk is too high compared to the cardiovascular risk that's been reported for active smokers? DR. GLANTZ: Well, most of the criticism I'm aware of has come from the tobacco industry's consultants. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1653
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 20 21 22 24 25 467 I know of ~wo independent scientists who have raised the issue -- Nicholas Wald and Richard Pito from England. Pito, I was very discouraged to hear, hadn't read our work when he was making the criticisms, which I thought was pretty irresponsible. The issue does come up and it is addressed in my testimony because the risks are higher than you would expect if you assume a linear dose response relationship. The risks for active smoking and heart disease are about 2 to 4, depending on the presence of other risk factors. The passive smoking risk is about 1.3, so since the dose that a non-smoker gets of ETS may be I percent of what a smoker gets, it does seem that the risk is too big, but that's the reason I presented the animal data that I did and the platelet data because it appears to me that, first of all, that nonsmokers responses to passive smoking are qualitatively different than smokers' responses, and that there's a very, very steep dose response relationship at low doses, so there's no reason to assume a linear or a sublinear curve, and I think that the animal and clinical data supports a superlineal curve that the additional effects at very high doses that a smoker gets produce relatively small changes over the relatively low doses that a nonsmoker gets. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1654
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 468 I think the experimental evidence, both the animal data and also the clinical studies, supports that view. MR. SIRRIDGE: Your Honor, I'd like to take back that estimate of 45 minutes, because I'm going slower than I thought I might. JUDGE VITTONE: Okay. You're coming up on 3:00, and you started at 2:30. MR. SIRRIDGE: And you recall I have 17 numbers to examine under. JUDGE VITTONE: I understand. MR. SIRRIDGE: Thank you. Let me ask -- JUDGE VITTONE: At this point, it may be appropriate for me to ask, both the questions and the answers, if we can tighten then up a little bit, it would be appreciated. MR. SIRRIDGE: DR. GLANTZ: it difficult but we'll try. JUDGE VITTONE: Well, the longer we stay here, maybe the tighter the answers will get. MR. SIRRIDGE: That's usually what happens, Your Honor. I'll do my very best. I think both of us are going to find DR. GLANTZ: That's how I get papers out of my BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1655
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 469 students, ~oo. MR. SIRRIDGE: Dr. Glantz, let me add a third dissenter to your view, 1.3 is the right risk and not too high. It comes from an OSHA consultant who will be testifying later this week, Dr. Jonathan Samet. DR. GLANTZ: Yes. MR. SIRRIDGE: Are you familiar with him? DR. GLANTZ: I think I met him once, but I know who he is. MR. SIRRIDGE: He writes in a publication in 1992, entitled, "Environmental Tobacco Smoke": "The extent of the excess risk associated with passive smoking seems high in view of the relative risks observed in active smokers, approximately twofold increases," and he cites the Surgeon General for that. DR. GLANTZ: Yes. So what's the question? MR. SIRRIDGE: Would you agree that there is now" a third dissenter? You knew of two and I'm adding one. DR. GLANTZ: I would say that in 1991, when he probably wrote that, that was probably an accurate representation of his view. I don't know what his current views on it are. You can ask him when he's here. It's important that a lot of the evidence on passive smoking and heart disease is relatively recent, and when you quote from old documents, like the '86 Surgeon BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1656
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1 2 3 4 5 6 7 8 9 i0 iI 12 13 14 15 16 17 18 19 20 21 22 23 24 25 470 General's !eport or the National Research Council's report, that said there's not enough evidence to say, those were accurate statements when they were made because that was before most of the evidence was published. Most of it dates from the late '80s and into the early '90s, so I don't know what Samet's view would be today. MR. SIRRIDGE: He certainly had the benefit of your paper in 1991. Would that have been helpful to him? DR. GLANTZ: Did he cite our paper? MR. SIRRIDGE: Yes, he did. DR. GLANTZ: Yes. Well, it was a new paper then, and it takes a scientific community a while a to reach a consensus. MR. SIRRIDGE: Doctor, would you agree that several risk factors, such as lack of exercise, diabetes and Type A behavior pattern, were almost never controlled for in the epidemiologic studies that you have referred to and relied on for your views? DR. GLANTZ: MR. SIRRIDGE: DR. GLANTZ: I should just leave this one up. I can move this along by just -- Well, you're asking questions, and I'm trying to give you responsible answers. MR. SIRRIDGE: Thank you very much. DR. GLANTZ: I would say that, as direct BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI 1011-1657
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1 2 3 4 5 6 7 8 -9 i0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 471 covariates~ no; indirectly through controlling for socioeconomic status, diet, and things like that, yes, to some extent. MR. SIRRIDGE: So socioeconomic status controls for lack of exercise? DR. GLANTZ: To some extent. MR. SIRRIDGE: What study is that? DR. GLANTZ: I would have to go get you the references. That's some that's generally known. I mean, it's something that's generally known among people who work in this area. Again, I think it's very important that, in Wells' work, when he showed the better job you did of controlling for the potential confounders, the higher the risks attributed to ETS got. I think that's a very important finding because it shows that these potential confounders are not giving you an inaccurate view of what's happening, but rather, if anything, obscuring the ETS effect. MR. SIRRIDGE: Dr. Glantz, do you know if any of the studies controlled for coffee drinking? DR. GLANTZ: Not to my knowledge. MR. SIRRIDGE: Hasn't there been an association reported in the range of 1.3 to 2.5 for heart disease -- DR. GLANTZ: I'm not familiar. I mean, other BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1658
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i 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 472 than heariHg things in the popular press from time to time about coffee drinking, I'm not familiar with that data. MR. SIRRIDGE: Would you be surprised if the OSHA consultant, Neil Benowitz, published a study quoting the fact that there's an association of 1.3 to 2.5 relative risk for coffee drinking and heart disease? DR. GLANTZ: Would I be surprised? I don't have any reaction one way or the other to what Neil does. He was an independent scientist. published a study? MR.. SIRRIDGE: Why should I be surprised if he Do you think controlling, or do you think taking coffee into account, would have added another risk factor to examine, to determine, whether the risk of 1.3 is an accurate risk? Does socioeconomic status take care of coffee drinking? DR. GLANTZ: I'm not aware of any evidence that coffee driniking is correlated with ETS exposure in a way that could possibly influence the outcome of these studies, so my answer is, I would be very surprised if that ended up being an important factor. MR. SIRRIDGE: Wouldn't the relationship be, Doctor, whether cigarette smoking is correlated with coffee drinking, and then, therefore, you have a coffee drinker in the home, and isn't that the kind of dietary habits that people cite when they write articles, saying that those BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T! 1011-1659
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1 2 3 4 5 6 7 8 9 10 iI 12 13 14 15 16 17 18 19 ~.0 21 22 23 24 25 habits ten~ to conglomerate in households? There is the tie-in, Doctor. DR. GLANTZ: MR. SIRRIDGE: 473 I don't understand the question. The question is, cigarette smoking is related to coffee drinking. on it? on it? Isn't that true? DR. GLANTZ: I don't know that for a fact. MR. SIRRIDGE: Would you like to see an article DR. GLANTZ: Pardon me? MR. SIRRIDGE: Would you like to see an article DR. GLANTZ: Well, I can -- I mean, if you want - - I mean, I'm not going to -- the CRS study I had read before, I'm not going to speed read a scientific article and give you a judgment on whether I think it's good or not. If you want to give it to me, I'll be happy to read it later, and I can respond in a post-hearing comment. MR. SIRRIDGE: Let me ask, then: there are cardiovascular studies, studies on cardiovascular disease, which do control for coffee drinking as a potential risk factor. DR. GLANTZ: I'm not in the position to answer that one way or another as an expert. MR. SIRRIDGE: Doctor, you mentioned several mechanisms, in your view, that ETS may be involved in the BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1660
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 474 development of atherosclerosis. These are proposed theories, or hypotheses, aren't they, Doctor? DR. GLANTZ: The explanations of the mechanisms of atherosclerosis that I discuss are current best understanding of how atherosclerosis is initiated and continues. This is an area which people have researched and will research for years. I would say they represent the current consensus view of what happens which, in science, is instantly the can't hypothesis and theory. So I would say that it is the current hypothesis and theory, but that also means it's our current state of knowledge. MR. SIRRIDGE: Doctor, are you more careful when you write in journals about things being theories and proposed hypotheses than you were this morning? DR. GLANTZ: Yes. MR. SIRRIDGE: Are you more careful? DR. GLANTZ: No, I've tried to be very careful what I write. For one reason, I know you guys will take it apart. I mean, I published a document with the restaurant study, that I'm sure will get to you, that had an append±x full of numbers, and found the one typographical error in it for me. MR. SIRRIDGE: I didn't see that study. DR. GLANTZ: Well, you didn't, but the tobacco BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1661
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1 2 3 4 5 6 7 8 9 10 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 475 companies Bid. So I plan on all my things being very carefully reviewed by them. MR. SIRRIDGE: In fact, if you called them proposed theories or research hypotheses in your articles, you stand by that today? DR. GLANTZ: Well, that's not the kind of language I usually use when I'm writing, generally. [Pause.] JUDGE VITTONE: MR. SIRRIDGE: JUDGE VITTONE: MR. SIRRIDGE: Mr. Sirridge :- I'll move off that. Are you almost done? I'm sorry. I'll move it "along. Let me just finish that line, because it does take a while. I'm sorry. JUDGE VITTONE: Sure. That's all right. Go ahead. MR. SIRRIDGE: Your Honor -- or, actually, Dr. Glantz -- I won't ask you a question. DR. GLANTZ: You can. [Laughter] JUDGE VITTONE: I'm not sure how much value I'll give. MR. SIRRIDGE: be very helpful. JUDGE VITTONE: As long as it's short, that would You want yes and no answers? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1662
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1 2 3 5 7 8 -9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 476 MR. SIRRIDGE: Yes. I like yes and no answers. I like the courtroom. Dr. Glantz, isn't it a fact the pathophysiological data are too limited in scope to prove any of your postulated mechanisms as to how ETS may cause heart disease? DR. GLANTZ: I would say that the mechanisms we suggest are consistent with a large body of data that's understood about the mechanisms of the induction and promotion of heart disease. MR. SIRRIDGE: I'm quoting Dr. Samet again from that same publication: "Pathophysiological mechanisms can be postulated with the increased risk associated with passive smoking, although the relevant experimental data are still limited in scope. " DR. GLANTZ: I would say that in 1991, when he probably wrote that, that was an accurate statement. The experimental data, the work that we've done, that I reported here, work by Arthur Penn and others, has all been published within the last couple of years, so it really post-dates that article. I think probably when he made that statement, it was accurate. I mean, we would have -- and perhaps I did say tentative hypothesis, or something in the paper Bill BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1663
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1 2 3 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 477 Parmlee and I wrote, I noticed you looking through -- at that point, there was evidence that benzopyrene and certain of the other chemical constituents of ETS played a role in atherosclerosis. Since then, there's been direct experimental evidence by us and Arthur Penn, who was funded by the Center for Indoor Air Research, in fact, that have provided direct cooperation, and I think that significantly strengthens the case, and that all came out in the last couple of years. MR. SIRRIDGE: All the questioners who follow me, take that up, and I'll try to move along to save time. Doctor, you mentioned meta analysis in your remarks this morning. DR. GLANTZ: Yes. MR. SIRRIDGE: Have you done a meta analysis on the studies that contained data on work place exposure to ETS and that relationship with heart disease? DR. GLANTZ: No, I haven't. The reason I haven't is I think that there aren't enough of them and I think they're too small to have it really make much sense. For the same reason, if you look in our 1991 paper -- Bill Parmley's and my 1991 paper -- we did not include any analysis of non-fatal endpoints, which are included in my testimony. The reason we mentioned we didn't include a BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TII011-1664
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1 2 3 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 25 478 formal analysis was we thought it was premature. There wasn't enough data to do it well. MR. SIRRIDGE: Well, Doctor,would you agree with Mr. Martonik, who stated yesterday that studies with work place exposure data on ETS, would be preferable studies for OSHA to analyze in terms of the relationship between ETS and -- DR. GLANTZ: I don't particularly agree with that, no. MR. SIRRIDGE: You don't agree with it? DR. GLANTZ: No. MR. SIRRIDGE: Do you know which epidemiologic studies do have work place data? DR. GLANTZ: The one -- let's see. The Dobson study, Peter Lee study, and the Svendsen study, I believe. MR. SIRRIDGE: What do those studies show with respect to work place exposure? DR. GLANTZ: The Dobson study showed no significant effect. That I could state clearly, because I looked at this morning. The Peter Lee study and the Svendsen study, I can't recall. If you want to stop, I can look at them. MR. SIRRIDGE: Well, we're rolling now, so my time is drawing to a close. You deal with the issue of publication bias in BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1665
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 479 your statement submitted for the record? DR. GLANTZ: Yes. MR. SIRRIDGE: Have you done an actual study on the issue of publication bias with respect to environmental tobacco smoke and the literature on heart disease? DR. GLANTZ: I haven't, but Roger Beaglehole, who is with the epidemiology department in, I think, Wellington, New Zealand has, which included contacting everybody he could imagine in the whole world, and he made a presentation at the World Conference on Preventive Cardiology in Oslo about a year ago, and said that he could find no evidence of publication bias. Lisa Bero and I have published a study on publication bias and lung cancer and ETS and concluded that there wasn't any. And by the same criteria that were used in that paper, my guess is that we would reach a similar conclusion. The reason for that is that publication bias is usually defined and, indeed, it's defined in some of the comments submitted on behalf of the tobacco industry as a bias against publishing studies that don't reach statistical significance. In fact, if you look at the individual studies, as I pointed out in my remarks before lunch, many of the studies don't reach statistical significance. So, if BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1666
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 480 anything, ! think there's a bias toward publication of so- called negative ETS studies. Another thing which I think contributes to that is it's area where there's a tremendous amount of interest in it, and so I think that helps get this work published, and the other thing is that the tobacco industry is screened so loudly about publication bias that I think editors, in fact, have a pro publication bias for studies related to ETS. MR. SIRRIDGE: Doctor, did Mr. Repace or someone else from OSHA -- someone else with OSHA -- send you a copy of the submission from Dr. Maurice LeVois? DR. GLANTZ: Yes. MR. SIRRIDGE: You've seen that publication? DR. GLANTZ: That one, I have seen and read it, yes. MR. SIRRIDGE: It addresses the possibility that there could be publication bias in the sense that negative studies would not even be submitted. In that regard, Doctor, have you ever wondered why studies from some of the huge data bases in this country, in the smoking and health field, have not appeared with -- articles have not appeared -- in the literature regarding ETS and heart disease? DR. GLANTZ: You've asked two questions. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI 1011-1667
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 481 . The first question is -- MR. SIRRIDGE: I'm sorry about that. DR. GLANTZ: No, that's okay. What do I think about Mr. LeVois' submission. MR. SIRRIDGE: I said, had you seen it. DR. GLANTZ: Yes. Oh, have I seen it, yes. Then I was going on to characterize it, but go ahead. DR. GLANTZ: Well, no, go ahead. If we could, could we finish with that and then we could address the second question separately? JUDGE VITTONE: What is the question right now? It was lost. DR. GLANTZ: The second question was, am I surprised that other studies haven't-been done using the existing large data bases? MR. SIRRIDGE: I didn't say surprised. I said, have you ever wondered why? DR. GLANTZ: Oh. JUDGE VITTONE: Can you answer that? DR. GLANTZ: Have I ever wondered why? Oh, I, frankly, haven't much thought about it. I mean, there are many things in life that one hasn't thought about i~. JUDGE VITTONE: Next question. MR. SIP, RIDGE: Okay. DR. GLANTZ: I'll let you lead me to where you're BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1668
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1 2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 going. 482 MR. SIRRIDGE: That's fine. Have you contacted any researchers who work with the large prospective smoking and health data bases and asked whether they have done any analyses on the question of ETS exposure and heart disease? DR. GLANTZ: In response to Mr. LeVois' comment, I did over the weekend, yes, since I somehow guessed you would ask me. MR. SIRRIDGE: DR. GLANTZ: Who did you contact? I talked to Michael Toon at the American Cancer Society, who is responsible for the CPS I and CPS II data sets. MR. SIRRIDGE: Have they done such an analysis? DR. GLANTZ: He said that they done a preliminary analysis that showed an increase in risk, and I sent him Mr. LeVois' study and asked him what he thought of it, and he had some very serious problems with it. First of all, unlike most scientific papers, it doesn't include a method section, so we can't really tell exactly what he did. In fact, one of the real marks of a poor quality study is the lack of a methods section. In particular, he doesn't seem to have controlled for any of the confounding variables that you have expressed concern over. In particular, he didn't control for AIDS, which is a very important confounding variable. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1669
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 15 16 17 18 19 2O 21 22 23 24 25 483 _Another problem with using the CPS I and II data sets is they only have -- the CPS I data set had no questions about passive smoking on the questionnaire, as I understand it. The CPS II, I believe, had just a single question, and the only -- in Mr. LeVois' analysis of those data, he only looked at being married to a current smoker. So, for example, there's no measure of duration of exposure, and if you were married to a smoker for 50 years and then the person died, and you got the questionnaire the next day, you would have been counted as unexposed. So Mr. Toon's preliminary analysis -- and these all seem like reasonable criticisms to me -- was that there are real serious flaws with the analysis that was done. Larry Garfinkle had used one of those two data sets -- I don't know which -- to do a study on passive smoking and lung cancer. MI~. SIRRIDGE: DR. GLANTZ: CPS I. Okay. CPS I, which came up with an elevation and risk that didn't reach statistical significance, and was fairly roundly criticized on the grounds that it wasn't an appropriate data set to use, which he actually said in his paper. When he subsequently did a case control study, he came up with results much more consistent with Hariyama and BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1670
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1 2 3 4 5 6 7 8 9 l0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 484 others. I think the criticism that the Access received about the misuse of the CPS data sets on passive smoking, I think has led them to be very cautious about drawing conclusions. Now, I have asked Michael Toon to run a proper analysis on those data sets for me, which I will -- if he has time -- attempt to submit in a posthearing comment, but I can't promise that they're going to do that. They may feel, with some justification, that that's just simply not an appropriate use of that data. Just because a data set is big, that doesn't make it. appropriate to do a given study. MR. SIRRIDGE: I can't remember what the question was. Doctor, you indicated earlier to me, when I asked you whether you had submitted your materials on heart disease to the Environmental Protection Agency. DR. GLANTZ: Um-hum. MR. SIRRIDGE: The EPA has not issued a risk assessment on ETS and heart disease, have they? DR. GLANTZ: The EPA -- now, could you be precise about what you mean -- you mean a risk assessment in the same sense as the document that was released in, I think, December of '92? BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1671
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 485 . MR. SIRRIDGE: That is correct. DR. GLANTZ: That is a correct statement. The EPA has not conducted a formal agency analysis of passive smoking and heart disease. materials? MR. SIRRIDGE: DR. GLANTZ : Despite receiving your voluminous I didn't send them voluminous materials. They asked me to write a review of the current state of the literature as of 1990, I believe, which I did. It was never meant to be a formal agency document, in the sense that the lung cancer risk assessment document, as the document that it was prepared for was a review document written by invited outside authors. It was never, as I understand it, meant to be an EPA agency document. It was reviewed through a different peer review mechanism. It was just a different kind of document. I didn't send them voluminous materials. It was about 25 pages and what they asked me to write. JUDGE VITTONE: contemplation. MR. SIRRIDGE: JUDGE VITTONE: Mr. Sirridge, you're in I,m prepared to pass the baton. Thank you very much. MS. SHERMAN: Your Honor, Dr. Glantz has been answering questions for over an hour now. I think that BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1672
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 maybe a skort break would be in order. JUDGE VITTONE: All right. minute recess. [Recess] JUDGE VITTONE: questioning. 486 We'll take a five- Mr. Rupp, you're next in line for MR. RUPP: Yes, I am, Your Honor, and thank you very much. I have identified myself for the reporter. The people whom I am representing are the same as Yesterday, and the reporter has acknowledged that she has that information. I am also joined today by Abrahm Hoffman and Konrad Bonsack of Price Waterhouse, and they'll be assisting me in a portion of the examination. I will give business cards for those gentlemen to the reporter, if that's acceptable. JUDGE VITTONE: Okay. MR. RUPP: Dr. Glantz, when I was preparing for this examination last night, I must say I was struck by the range of your. expertise, particularly so far as tobacco is concerned. That is, you published in the past on tobacco and advertising, tobacco and economics, tobacco and taxes, tobacco and health, the social psychological dynamics of tobacco. I noticed passages with respect to what you called addiction to tobacco. It's really quite a Catholic BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1673
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 15 16 17 18 19 20 21 22 23 24 25 487 interest ygu have in tobacco. DR. GLANTZ: Thank you. MR. RUPP: Would you regard yourself to be a longstanding anti-tobacco activist in a political sense? DR. GLANTZ: Yes. MR. RUPP: Are you also the founder, in 1983 or 1982, of Americans for Nonsmokers Rights, at that time, called Californians for Nonsmokers Rights? DR. GLANTZ: It was in December of 1980. MR. RUPP: In those early days -- the early 1980s, if you will -- I take it there were fewer anti- tobacco actvists at that time then there are currently, certainly, so yours was a bit of a frontier operation, in a sense? DR. GLANTZ: MR. RUPP: Yes. Do you remember a speech you gave -- and I'm going to go a little later now, but it's an interesting speech, I thought -- at the 7th World Conference on Tobacco and Health in Perth, Australia, in April of 1990? DR. GLANTZ: Yes. MR. RUPP: Let me quote to you from that speech, if I may. Your Honor, I'm going to ask this to be marked as an exhibit, and I think it would be Exhibit 17. I will offer it at the conclusion of my examination on it, if I BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1674
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1 2 3 4 5 6 7 8 9 10 ll 12 13 14 15 16 17 !8 19 2O 21 22 23 24 25 may. 488 JUDGE VITTONE: All right. (The document referred to was marked for identification as Exhibit 17.) MR. RUPP: Let me quote to you from the second page of that speech, Dr. Glantz. After having discussed some smoking restriction proposals that you had made at a previous conference in 1983, you made this statement: "It's very nice to see that some of the same ideas that a few of us were advocating in 1983 which were viewed as so strange, radical, and hopeless, have now become so very mainstream. So not only am I talking about history, but I'm even presenting ideas that are accepted, and I'm having a very hard time coping with this. As I tell people, I've gone from being a lunatic to being an expert, and I don't think I've changed that much except that I've gained weight, because, you see, I don't smoke and I don't drink much, and I don't engage in high-risk sexual activities, and all that's left is food." I take it the use.of the word "lunatic" was perhaps hyperbole? DR. GLANTZ: Yes, that was a joke. MR. RUPP: Okay. DR. GLANTZ: If you listened to a tape, people BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1675
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1 2 3 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 laughed. the tape. 489 MR. RUPP: Yes, they did, and I have listened to In a later portion of the speech -- DR. GLANTZ: Let me -- JUDGE VITTONE: Gentlemen -- gentlemen. DR. GLANTZ: If I could respond, because -- JUDGE VITTONE: I'm going to -- DR. GLANTZ: mischaracterized. MR. RUPP: -- I don't want to be Let me ask a question. anything. said that. JUDGE VITTONE: I don't think he's characterized M~. RUPP: I haven't. I'm asking you whether you DR. GLANTZ: I told that joke, yes. MR. RUPP: Right. At a later portion of the speech, you said: "Well, I did do a paper on science yesterday, which they let me put on the program or I would have told you about sticky platelets today. One of the great assets that we have stumbled onto in the fight over smoking are nonsmokers," end of quote. Now, the question I have is this: That statement almost suggests to me that you were quite pleased to think BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1676
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 490 that nonsmokers might be put at risk by other people's tobacco smoking because that would be a political advantage to you. Do I read the incorrectly? DR. GLANTZ: MR. RUPP: DR. GLANTZ: Yes, you read it incorrectly. Okay. It's very important to state that my interest in this area followed from the science not the other way around. MR. RUPP: DR. GLANTZ: Mr. Rupp. I'm sure that it did. I'm glad that you recognize that, MR. RUPP: Let me go on and quote further from the speech. You indicate here that it's very important for anti-tobacco activists to be as visible as possible and to try to involve the media in the efforts as much as possible. You say, and I quote: "And if you do something that is politically invisible, it will get covered. The tobacco companies can suppress features but they can't suppress news stories. The second thing you should not be is a health fascist. You should be an environmental lunatic. You are against air pollution. The environmental groups and good government groups in the United States have been particularly helpful. "And the last thing is you need to convince legislators that if they oppose you, they will be perceived BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti 1011-1677
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 .14 15 16 17 18 19 20 21 22 23 24 25 491 as dupes of the cigarette companies, and Dick, whom we referred to earlier and will be shown in the transcript, has already talked about the very negative image that has." Now, the question I have is this: With this kind of verbiage -- and I take it this isn't a joke -- it's going to be a bit of a leap for some of us to make to also view you as a purely objective science, prepared to call things as you see them, without regard to politics or without regard to a hidden agenda. Can you help us? DR. GLANTZ: Pardon me? I didn't hear the question. I was just -- I was thinking about something else. MR. RUPP: In light of comments of this sort, which clearly this was not meant in jest because it's part of a very long passage -- DR. GLANTZ: Um-hum. MR. RUPP: -- it's very difficult for -- it's going to be very difficult for a number of people to make the leap into viewing you also as an independent objective scientist, not one having a political agenda in presenting statements of the sort you presented here. Can you help us get back into the objective scientific arena? DR. GLANTZ: MR. RUPP: Sure. Let me -- Put it this way. You -- BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1678
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 492 DR. GLANTZ: question -- MR. RUPP: DR. GLANTZ: MR. RUPP: Now, Mr. Rupp, you asked me a Let me make it easy for you. -- so let me answer it. How does one -- DR. GLANTZ: Mr. Rupp -- JUDGE VITTONE: Gentlemen -- gentlemen -- DR. GLANTZ: question -- MR. RUPP: -- Mr. Rupp, you asked me a Fair enough. DR. GLANTZ: -- now let me answer it. MR. RUPP: Fair enough. DR. GLANTZ: I'm a Professor of Medicine at the University of California, San Francisco. My professional career depends on being first and being right, as any scientist at a first rate academic institution, and I am very proud of the fact that I was one of the early scientists to recognize the seriousness of passive smoking as an issue and how to deal with it as a problem. Now, the passages that you are reading there were from a speech at a meeting. They include hyperbole, they include jokes. I am, as you may or may not know, a fairly colorful speaker. But it is absolutely -- and I want to underline absolutely not true -- to say that I have in any way twisted the science around to justify some preconceived BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1679
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 493 political.position. If I were presented with evidence which I found compelling, say that my past positions on this scientific issue are wrong, I would change my positions, as I have on many issues, scientifically, when presented with the data. I think, just as Surgeon General Koop, whose similar accusations have been directed on and many health professionals, I think it is ethically incumbent in a health professional to take public health action when you know what I know about this disease. Whether or not I am objective, my work is of scientific high quality, things like that, that is for my peers to judge, not for me. But I can tell you that the University of California has found this work acceptable, that the State of California has, and many other independent groups. In fact, the only organized groups that have found our work on ETS of low quality has been the tobacco companies, so I -- MR. RUPP: Well, we'll -- DR. GLANTZ: -- stand on my record. And I am proud of the fact that I have acted on my scientific knowledge. But it is very important, Mr. Rupp, for you and your clients to understand the causality here. The actions that I have taken in this area have been because of my BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1680
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 9.O 21 22 23 24 25 494 scientifiG knowledge not the other way around. MR. RUPP: All right. At a later portion of this speech you say, "The higher up you go in the political system the harder it is generally, and the good principles of guerilla war pick a target you can beat. And if you don't have the money or the clout on the national legislation, get local legislation, no matter how small the place is, a place where you can start to win." Do you regard this proceeding at OSHA to be a guerilla war? DR. GLANTZ: No. MR. RUPP: What is this? DR. GLANTZ: MS. SHERMAN: DR. GLANTZ: This is the OSHA proceeding. This is what? It's an OSHA proceeding. I would add, in fact, one of the slides I took out of my presentation to try to shorten it, was a statement from the Roper poll done for the Tobacco Institute in 1978, that identified the issue of the effects on smoking on nonsmokers is very important. MR. RUPP: I think that's already in the record, as a matter of fact. DR. GLANTZ: And I also -- well, okay, maybe someone else put it in. And also in that same report are discussions of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1681
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1 2 3 5 6 7 8 9 i0 iI 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 495 just the same points that you were quoting from in that speech that I gave, and, in fact, my ideas in this area, came from reading the Tobacco Institute's research, which I think was quite good in this area, and whoever did it back in 1978, was a very smart person, because they predicted how th~s whole issue has evolved. MR. RUPP: I'll take that back to them. I'll take them back to them. may. DR. GLANTZ: MR. RUPP: Let me ask another question, if I Okay. Near the end of the speech you congratulate the people who had received awards frbm the anti-smoking organizers who had been responsible for the meeting, and then pointed to a fellow who had not received an award, and you say: "But, you know, activists need to not only be rewarded, and I also took exception, I had no objection at all to the people who were given awards on the first day, but I did notice there was not a single lunatic among them, but they should not be screwed either by people who were supposed to be on their side, and I think the message that that sent, the word got around, and when there are good people working in the health agencies, and there are many good people who want to go out a little bit on the edge, they need to see that they will be rewarded." BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T! 1011-1682
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1 2 3 4 5 6 7 8 .9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 496 Is that really what this -- would you apply those kind of comments to this proceeding? DR. GLANTZ: I think it's totally inappropriate for this thing. I mean, I was giving a speech. It was a colorful speech, it was hyperbole, and it was -- if you listen to the tape, people laughed through parts of it. I think this is a completely different sort of proceeding that you're dealing with here and, in fact, the times are completely different. MR. RUPP: I hope that's true. DR. GLANTZ: Yes. MR. RUPP: Your Honor, I'd like to offer this transcript into the record of the hearing as Hearing Exhibit 17. JUDGE VITTONE: MS. SHERMAN: Any objection? I think it would probably be better for t~e purposes of the transcript, unless you're going to ask some more questions from it, that you enter it with your own exhibits at the time your people testify. MR. RUPP: Again, I won't be testifying, and we have no one testifying on our behalf who is going to cover this ground again. I think it's important that the full transcript be in the record because I don't want it said at any point by anyone that I took something out of context, so I think Dr. Glantz' view of words should be in context and BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1683
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1 2 3 4 5 6 7 8 9 l0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 497 comprehensive. MS. SHERMAN: Okay. If you will make a copy available for Dr. Glantz to review, then I -- MR. RUPP: I would be more than happy to do that. MS. SHERMAN: -- don't have any objection to it. MR. RUPP: Thank you very much. JUDGE VITTONE: Okay. Do you want to wait, though, until you've had a chance to review this or do you have no objection now? MS. SHERMAN: Well, if Mr. Rupp is very concerned about getting it in, I would not mind you allow it in the record subject to Professor Glantz' comments on it, after he has had a chance to review it. MR. RUPP: I have no problem with that. There's a rebuttal period, and he, of course, can say anything he cares to about it. JUDGE VITTONE: Okay. Could you identify it more specifically? MR. RUPP: Yes, I can, Your Honor. It is entitled, Seventh World Conference on Tobacco & Health, Perth, Australia, April 1990 Transcript. The speaker is listed as S. or Stanton Glantz. JUDGE VITTONE: All right. DR. GLANTZ: Your Honor, since it's being entered into the record, I'd like to just offer a couple of very BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1684
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1 2 3 4 5 6 7 8 9 I0 i'i 12 13 14 15 16 17 18 19 20 21 22 23 24 25 498 brief comments. MR. RUPP: I'm going to object to that. There is a rebuttal period, and that's what the rebuttal period is for.~ I've asked questions, you've answered them, and I appreciate your answers. JUDGE VITTONE: What's the rebuttal period -- MR. RUPP: You'll have an opportunity for a rebuttal period, but my time runs and I'll ask the questions. JUDGE VITTONE: Which the rebuttal period will follow at the close of the formal testimony here, right now, which is planned for December 2nd. There will be a period of time in which parties can submit additional comments. You will have that opportunity as well as anybody else who testifies at this proceeding. DR. GLANTZ: All right. I'm not -- MR. RUPP:- There are a number of articles -- JUDGE VITTONE: Gentlemen -- gentlemen -- DR. GLANTZ: Well, I'm not going to be able to travel back to Washington. JUDGE VITTONE: You're not going to have to travel back. You can submit them in writing, if you like. MS. SHERMAN: Mr. Rupp, we'll make that available. JUDGE VITTONE: There will be a formal period BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1685
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1 2 3 4 5 6 7 8 9 l0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 where people will come back for the rebuttal period to testify again. I will receive what you have identified as Exhibit 17 in the record. (The document previously marked for identification was received into evidence as Exhibit 17.) JUDGE VITTONE: opportunity to review it. will be able to submit any kind of written analysis or comments that you want to make. area? All right. 499 Dr. Glantz, you will have an During the rebuttal period, you Mr. Rupp, are we moving onto another MR. RUPP: Yes. I'm just going to identify a couple of additional documents of the same sort, and I'm not going to ask questions about them, but, again, I think it appropriate that Dr. Glantz be given copies. I would like to offer their entry into the record at this point, and then subject to any comments he may care to make or any objections Ms. Sherman may have, I would request that they be received in evidence at this time. MS. SHERMAN: Can you make these available to him by tomorrow morning? MR. RUPP: I certainly can. Let me identify them, then, at this point. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1686
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 5OO One is an editorial entitled, Achieving a Smoke- Free Society. It appeared in the publication Circulation, I think the only article by that name that Dr. Glantz has published. There is a 1983 brochure from Californians for NonSmokers Rights, entitled, Thank you for Not Smoking. Also in 1983, article from Californians for NonSmokers Rights, which begins with the.sentence: On June 3rd, San Francisco Mayor Diane Feinstein signed an important piece of legislation to control air pollution. An article by Stanton Glantz and Joe Ti and Kenneth Warner on tobacco advertising on consumptibn, Evidence of a Causal Relationship. Finally, legislative approaches to a Smoke-Free Society by Peter Hanower, Glen Barr, and Stanton Glantz, and this is a publication from the Americans for NonSmokers Rights as well. We will, as I said, make sure the Dr. Glantz as a copy of all of these publications. MS. SHERMAN: I don't quite understand. Are you just entering these into the record as a public citizen, or are you going to ask Dr. Glantz some questions about them? What is the purpose of this? MR. RUPP: If there were time, I'd love to ask questions of them, but -- BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1687
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1 2 3 4 5 6 7 8 • 9 10 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 501 MS. SHERMAN: Okay. Well, what is -- MR. RUPP: -- at this point -- MS. SHERMAN: -- purpose of your submission? MR. RUPP: -- we will be making presentations to OSHA on the basis of these articles, so I think they need to be in the record. We'll make copies of these for Dr. Glantz. We can get them to you by mail, or we can give them to OSHA to be provided to you through OSHA, whichever you would prefer. JUDGE VITTONE: Why don't you just mail them to him. Are you going to attach exhibit numbers to that? MR. RUPP: Yes, I can do that. Why don't we do that now so that we have no confusion. In the order in which I read them it would be Exhibit No. 18, Exhibit No. 19, Exhibit No. 20, Exhibit No. 21, and Exhibit No. 22, and I will provide them in that order as well. (The documents referred to were marked for identification as Exhibits No. 18, 19, 20, 21, and 22.) JUDGE VITTONE: Exhibits No. 18 through 22 identified by Mr. Rupp, will be received into the record in this proceeding. (The documents referred to, having been previously marked for identification as Exhibits BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1688
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 502 No. 18, 19, 20, 21, and 22, were received in evidence.) MR. RUPP: Thank you very much, Your Honor. Dr. Glantz, let me move now, if I may, to the portion of your testimony that dealt with the impact of smoking restriction ordinances in the state of California. My understanding is that your first study of the affect of such ordinances was prepared in March of '92, is that correct? MR. GLANTZ: I believe so. MR. RUPP: And my further understanding is that at that time you were studying four California cities -- Beverly Hills, San Luis Obispo, Lodi, and Bellflower, had imposed such ordinances, is that correct? MR. GLANTZ: I believe so. MR. RUPP: And you relied on sales data collected by the California State Board of Equalization that presented taxable restaurant and total retail sales data on a quarterly basis, is that correct? MR. GLANTZ: Yes. MR. RUPP: After your first study on June I, 1992, you issued a short report in which you responded to, and I quote, "several criticisms the tobacco industry has advanced" concerning your findings. Do you recall that? MR. GLANTZ: Yes. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1689
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 503 MR. RUPP: The first criticism you identify is, and again, I quote, "That the numbers are wrong, other surveys reveal there was a drop in sales." And I take it you're ascribing that to the tobacco industry. To that you responded, and again, I quote from the document, "IT is important to emphasize that the data we used on restaurant sales did not come from a survey we did. These values are from the sales figures reported to the California State Board of Equalization for purposes of paying sales taxes. The only way that these numbers could be wrong is if the restaurants were lying on their tax returns. Do you remember making that statement? MR. GLANTZ: Yes. MR. RUPP: And I think you repeated a statement along those lines this morning, did you not? MR. GLANTZ: I believe so. MR. RUPP: I'd like to ask you a series of questions about that sentence, and I'd like to quote first in that.connection from a research paper published in 1994 by the Clairmont Graduate School entitled "The Impact of Tobacco Control Ordinances on Restaurant Revenues in California." The paper, which you undoubtedly have seen, but if you have not, I can give you one, states in part as follows, and I quote: "The State Board of Equalization combined sales BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1690
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1 2 3 4 5 6 7 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 5O4 from bars. not subject to smoking restrictions and sales from restaurants in one classification, making it difficult to isolate the effects of smoking restrictions.,, Were you aware, Dr. Glantz, that the SBE figures upon which you were relying were lumping bar and restaurant sales into the same category? MR. GLANTZ: There are actually three subcategories. In one of the three subcategories which is the smaller of the three, that is correct. We were aware of that. Also the statement that you quoted, that the only way the Board of Equalization numbers could be wrong is if someone lied, turned out to not be correct, because the Board of Equa%ization actually found a couple of reporting errors in their data which... MR. RUPP: I think I'm aware of those and we'll come to those in just a moment. Let me read you another of the caveats found in the Clairmont publication, and this, perhaps, goes to the point you were just starting to go into. "State Board of Equalization data exhibit considerable volatility. Yearly changes of 20 to 30 percent are not uncommon. Some of this volatility arises from late reporting of revenue unrelated to changes in business activity." Were you aware that that is, in fact, the case with the SBE figures? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1691
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1 2 3 4 5 6 7 8 9 10 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 5O5 . MR. GLANTZ: That was true for a couple of quarters of data. We actually caught those errors because the numbers changed by a lot more than the underlying variability, and we asked the Board to please check them, and they did find, I believe, two reporting errors that turned out to be important, and those were corrected. MR. RUPP: I think we're talking about two separate phenomena. We're going to get to what you're talking about in a moment. I'm talking now about... MR. GLANTZ: Then I don't understand the question. MR. RUPP: Let me finish my question. I'm talking now about the volatility that stems from late and early reporting of sales figures by the restaurants to the California State Board of Equalization Are you aware that there is a problem in volatility stemming from early and late reporting of sales figures by restaurants to the SBE? MR. GLANTZ: Based on my conversations with the Board of Equalization, except for the couple of instances that we've been alluding to, I don't think that's a major problem, nor did the people I talked to. We were concerned about that and spent quite a lot of time talking to people at the Board's research arm to deal with that question. It's a legitimate issue. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8S93
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1 2 3 4 5 6 7 8 o9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 5O6 _ MR. RUPP: Mr. Rossi was one of the people with whom you consulted? MR. GLANTZ: Yes. MR. RUPP: The Clairmont publication that I mentioned a few minutes earlier goes on to explain, and I quote, "If a vendor files a late report, the SBE will ensure that those taxable sales are reported in the appropriate quarter only if in the prior year the vendor accounted for at least ten percent of the taxable revenue in the vendor's classification. When there are many vendors in a particular classification, late .filed revenues of one quarter may be lumped with the revenues of the succeeding quarter. This practice can cause large quarterly revenue changes unrelated to business activity." Did you ever discuss that with Mr. Rossi, as we have? MR. GLANTZ: Yes. MR. RUPP: Did he confirm to you as he did to us and to the Clairmont authors that that was, indeed, a problem? MR. GLANTZ: What he told me when we talked about this was that those changes tended to sort of balance out. When you're looking for changes, which is what we were looking for in our study, that generally wasn't a big problem. There were a couple of instances that we found. I BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T! 1011-1693
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 507 believe one was in Paradise. I can't remember where the other one was. Where it was a significant enough amount of money that it introduced significant artifacts into the results. But as a general issue, he did not indicate to us that in terms of the kind of study we were doing, that that would be a big problem. It's also important to emphasize that the Clairmont study you're quoting from concluded no effective restaurant ordinances on business, and I hope you will enter that into the record. MR. RUPP: moment. We'll certainly get to that in a MR. GLANTZ: Thank you. MR. RUPP: Robert Rossi of the SBE has informed us that there is yet another problem with the SBE figure so far as our objectives today are concerned and the use to which you've made of the figures, frankly. That is that sales also can be placed in the wrong quarter due to early reporting. Were you aware of that problem? MR. GLANTZ: MR. RUPP: MR. GLANTZ: I didn't hear the question. Early reporting. That is... Would you repeat the whole question? was eating a piece of ice. MR. RUPP: No problem. Robert Rossi of the SBE has informed us that BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1694
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 22 23 24 25 5O8 there's also a problem with early reporting. If there's early reporting of revenues they will also be placed in the wrong quarter. Were you aware that that was a problem? MR. GLANTZ: Again, when I discussed this with him a couple of years ago when we started this study, he seemed to think that these errors all tended to balance out in terns of the overall figures. MR. RUPP: Did Mr. Rossi ever tell you that No effort was ever made by the California State Board of Equalization sua sponde. On its own, if you will, to investigate any of these kinds of issues the numbers simply went in where they went in, and no systematic effort unless somebody requested a relook at the figures. No systematic effort was made to determine which quarter the monies should be put into, the report should go into. They were entered by date received. Were you told that by Mr. Rossi? MR. GLANTZ: You're asking very specific questions, and I'm trying to give you specific answers. Those p~oblems were generally discussed, and Mr. Rossi at our request, we provided him with all of our data, our analysis of their data, and asked him to check that stuff for us. I don't know if we had the specific conversation that you're alluding to, but I do remember him telling me one time that since we had started doing our study there had been a tremendous amount of interest in making sure all of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1695
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 509 this stuff was right. To the best of my knowledge, the numbers that we were using accurately reflect the sales -- at least in terms of measuring changes. Mr. Rossi was very helpful to us, and another fellow whose name I can't remember, in trying to ensure that we had numbers which were representative of what was actually going on. MR. RUPP: The fact is, Mr. Glantz, it's not that Mr. Rossi reached out to you to try to make sure that your figures were accurate, but the reaching out went the other way, was it not? Let me describe the situation... MR. GLANTZ: Can I answer the question? MR. RUPP: Let me describe a situation and see whether it's correct. MR. GLANTZ: I'd like to answer the question. MR. RUPP: If you'll let me ask the question, please. I've not completed forming the question. MR. GLANTZ: I'm sorry. MR. RUPP: The situation that I have in mind is. this one. I know that you're aware that your original study included a transposition error for restaurant sales made in San Luis Obispo for the fourth quarter of 1990. That's the error to which you referred. My understanding is that you had used a figure Qf approximately $15 million for restaurant sales during that quarter. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1696
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5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 510 MR. GLANTZ: That's not correct. MR. RUPP: Let me finish the question, and you can point out where I'm in error, and I appreciate that. You had used a figure, and i'll be precise, $15,033,000 when the State Board had actually reported $10,533,000. That initially proved to be a disturbing error since the $i0 million sales figure would have represented an alarming drop in restaurant sales. My understanding is that when you learned thit the reported figure was ten, saw that the reported figure was ten, you went to Mr. Rossi and asked him to check whether the figure could not be higher. Now is my understanding wildlyinaccurate, or inaccurate in any respect? MR. GLANTZ: It's very misleading. You are correct in saying that we approached Mr. Rossi, because we were very concerned that our study, that the data we used was accurate. There were two different problems. We had started working with him in terms of making sure the data was accurate very, very early in the process, before we had published anything. There are two errors that you're talking about which are two distinct errors, and it's important to understand the difference. MR. RUPP: I think there were three. BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1697
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 23 24 25 511 MR. GLANTZ: I'm talking specifically about the San Luis Obispo. The first error was in the initial report we published as an Institute for Health policy monograph. I decided to just publish all of the data to make it available to anybody who wanted to check our work. As luck would have it, a very key quarter, the first quarter of the San Luis Obispo ordinance, there was a transposition error in the table in the report. MR. RUPP: That's the one to which I referred. MR. GLANTZ: Right. But it's very important to state for the record that the number that was in our computer data base, the statistical file that was used for the actual analysis, was the correct number. MR. RUPP: In your private data base. MR. GLANTZ: In the data base which was used to do t~e statistical.. MR. RUPP: error. But in the publication it was in MR. GLANTZ: The publication had the wrong number in it, but the number that was used to compute the statistical results, which were also reported in that report, was correct. So the results in the report, the conclusions in the report, were correct. MR. RUPP: But unless someone went back and did BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1698
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 512 the statistical calculation, they would look at the $i0 million figure and be misled. That was not the correct figure. MR. GLANTZ: That's the second problem that existed. The second problem was that there was a significant reporting error in that quarter in San Luis Obispo, which we did approach Mr. Rossi about and they subsequently corrected. That was not the only data point that we approached him about. We went through all of the data and looked for statistical outliers, and any outliers that we found during the entire period of the study, and there were several others, we asked them to go back and double check to make sure they were accurate points. This is the standard scientific procedure that you use when you're doing a statistical analysis, and outliers can lead you to very misleading results. MR. RUPP: My understanding is that Mr. Rossi informed you at that time that when the SBE discovers errors in SBE sales figures, the SBE does not publish revised figures. The errors remain undisclosed. Do you know of any practice by SBE that is different from Mr. Rossi's explanation? That is any systematic revisions they either undertake, or any revisions that they themselves published, other than on specific BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1699
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1 2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 513 requests of a researcher such as yourself? MR. GLANTZ: I don't know the answer to that. For the record, the corrections that we have we requested from them in writing so that we had documentary evidence. MR. RUPP: And, indeed, you published the letter in one of your publications? MR. GLANTZ: We made it available to people because we'd been accused of lying. I wanted to make it clear that we hadn't fabricated anything. What the Board of Equalization's policies on this are, I have no idea. I have never asked Mr. Rossi. I was concerned that we base our work on accurate numbers. MR. RUPP: We've talked thus far about three different kinds of errors, or three different kinds of problems with the SBE figures. One is the lumping of restaurant sales and bar sales into the same category. The second, actually we talked about four. The second is late reporting of revenue figures to SBE so that they are put into th~ wrong quarter. The third is early reporting of figures to the SBE which puts them into the wrong quarter but an early quarter. And the final problem is simple mathematical errors which can occur, of course, in anybody's statistical empire, including yours and mine, I suppose. MR. GLANTZ: We didn't make any mathematical errors, we made a typing error. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1700
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 514 - MR. RUPP: I see. Maybe that's a fifth, then. In light of those four problems... MR. GLANTZ: Wait, wait. Excuse me. We did not make a mathematical error. I want the record to clearly reflect that. And to the best of our knowledge, based on our discussions with Bob Rossi and the other people we talked to in the research department at the Board of Equalization, we were using numbers which were representative of what was going on. Finally, it's important to state that there are ~actually three subcategories of restaurant sales and the bar revenues only affect one of those, and it's a relatively small, the sm~llest of the three categories. So I think that the questions that you're asking really don't accurate represent the actual nature of these problems. MR. RUPP: Let me just... MR. GLANTZ: The other point... JUDGE VITTONE: Gentlemen. MR. GLANTZ: ...that's very important, is that we acknowledge... JUDGE VITTONE: Dr. Glantz... MR. GLANTZ: ...these things in our paper. JUDGE VITTONE: Dr. Glantz. You've gone far enough. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1701
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 515 MR. RUPP: If you could just... We're going to be here an awfully long time, and I'm going to be standing here pleading with the Judge for more time, and he's going to be looking at me with darts in his eyes as indeed he has every right to be, and I'm going to be looking at you with darts in my eyes. So if you'd answer the questions that I ask. I'm not asking for a long exegesis of the state of the world, I just have specific things I'd l~ke to know. You have an opportunity for rebuttal. So listen to my questions, please answer them. We'll come back to the question of whether you have made mathematical errors in this at a later ~oint. The question I have for you is this. In light of the problems we've described, is it not an overstatement to say that the only way the numbers you reported in your 1992 publication could occur if the restaurants were lying on their tax returns. Is that an overstatement, Mr. Glantz? MR. GLANTZ: I've already said that it was. MR. RUPP: All right, let me move on then. MR. GLANTZ: At the point you made it, we were unaware of these other problems. MR. RUPP: Excuse me. MR. GLANTZ: Mr. Rupp, you want to ask your questions, I want to answer completely. MR. RUPP: I have no question pending at this BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1702
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1 2 3 4 5 6 7 8 .9 i0 iI 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 point. MR. GLANTZ: previous one. 516 I was finishing answering the JUDGE VITTONE: Gentlemen. You ask a question, answer the question, then we go on to the next question. I understand what you're trying to do, Dr. Glantz, but we'll move along a lot better right now and get finished here so we can move on to the next witness. MR. RUPP: Dr. Glantz, I'd like now to examine the first report you prepared, the March 1992 report, and to facilitate that I've had portions of that report blown up into charts. Basically it's a photographic enlargement so that whatever appeared in the original paper which is in the record, appears on this chart. Again, the first report focused on four California cities. MS. SHERMAN: Excuse me a moment, Mr. Rupp. I see that one of them says Exhibit A. (The document referred to was marked for identification as Exhibit A.) MS. SHERMAN: Is it labeled such in Dr. Glantz's report? MR. RUPP: (Pause) MR. RUPP: Let me figure that out. Dr. Glantz, can you see that if I put BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-17'03
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1 2 3 4 5 6 7 8 9 i0 iI 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 517 it here? -Is that too far away? MR. GLANTZ: I can see that it's generally a reproduction of our report. I can't read the numbers from here. MR. RUPP: I think it's less important for you because you will have these in front of you. If you do not, I will give you a copy. MR. GLANTZ: are. MS. SHERMAN: Would that be helpful? It depends on what the questions I would also like for you to make available a copy for the record if it is not labeled Exhibit A in his report, so when somebody reads the transcript we'll be able to tell what document was being discussed. MR. RUPP: That's a fair point, and I think the answer is that they are not labeled. They're labeled here A, B, C, D, and subsequently, with letters. I don't think they quite match Dr. Glantz's table numbers in his various charts. So I will offer these into the record. MS. SHERMAN: That's what I was afraid of. Do you have a more realistic size to offer for the record? MR. RUPP: I also have a smaller size. If you'd like to compare the two and then accept the smaller size, that probably is the better thing to do so that you're not burdened with these large viewgraphs. MS. SHERMAN: Thank you. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1704
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 518 MR. RUPP: I'll offer those when we're done. MS. SHERMAN: Thank you. JUDGE VITTONE: Off the record. (Discussion held off the record) JUDGE VITTONE: On the record. MR. RUPP: I'd first like to understand the methodology you used in the three models that you utilized to look at these data. Would you help me with that? MR. GLANTZ: Yes. We did three analyses. JUDGE VITTONE: Wait a minute. Does he have a copy of whatever that is in front of him right now? MS. SHERMAN: No, he does not. JUDGE VITTONE: Can we get him a copy? (Witness handed documents by Mr. Rupp) MR. RUPP: Dr. Glantz, I think we do not have to understand all of the intricacies of this, so I'm going to describe the methodology as I understand it. I'd like you to correct me if I have mischaracterized you in any significant way, the methodology, that is. Would you do that? MR. GLANTZ: Okay. MR. RUPP: My understanding is that what you did is took the SBE restaurant sales data and utilized multiple regression econometric models. The model included certain BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1705
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1 2 3 4 5 6 7 8 9 I0 11 12 13 14 15 16 17 18 19 2O 21 22 23 25 the data are, or whether they're hard or good or bad. 519 variables, to explain the changes in restaurant sales over time, and those variables, as I understand them are year, for the underlying time trend; quarter for seasonal adjustments; and a variable to indicate whether or not an ordinance was in effect at the time. I'm quoting from one of your publications, I hope accurately. MR. GLANTZ: Yes. MR. RUPP: My understanding is that the variables contained in the models that you used are so-called dummy variables, also a phrase that you've used in your papers. ~MR. GLANTZ: Some of them were, yes. MR. RUPP: And they are so called because in a sense they aren't hard economic data per Se. Rather, they're variables that can be represented by a zero or a one, a yes or a no. MR. GLANTZ: That's not an accurate representation. MR. RUPP: Okay, would you explain that, please? MR. GLANTZ: You use dummy variables or indicator variables to indicate a dichotomous variable, thatis something like the ordinance. It either is or is not present. MR. RUPP: That's a yes or a no. MR. GLANTZ: No, it has nothing to do with what It BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1708
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 520 has to do. with the kind of data that you're measuring. MR. RUPP: Exactly. I do understand that. MR. GLANTZ: Time is not entered as a dummy variable. The presence of the ordinance is. MR. RUPP: Fair enough. My understanding is that what you then did is you looked at or arrayed the data in three different ways in the original publication. separate compartments. MR. GLANTZ: MR. RUPP: They're represented here in three Yes. First you looked at total restaurant sales as reported, I was going to say as reported'to the CBE, but as the CBE was showing the State Board of Equalization, was showing those data on the books at that time. Total restaurant sales over the quarters that you looked at. MR. GLANTZ: Yes, subject to the corrections we discussed earlier. MR. RUPP: Also you look at restaurant sales as a fraction of total retail sales. Is that correct? MR. GLANTZ: That's correct. MR. RUPP: Finally, you looked at restaurant sales in what you call controlled cities, and compared those to restaurant sales in the banned cities. MR. GLANTZ: That's correct. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1707
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 521 ~.~. RUPP: I know that in an update of your original study you stopped talking about restaurant sales directly, and instead, addressed the impact of smoking bans by limiting your attention to the two ratios that I described. That is, restaurant sales as a percentage of total retail sales; and restaurant sales in the banned cities compared to the control cities, is that correct? MR. GLANTZ: Yes. Can I explain why we did that? MR. RUPP: I think I'm going to come to that. I think I understand it, and you tell me if my understanding is correct. MR. GLANTZ: Okay. MR. RUPP: I take it you abandoned the direct sales approach because you concluded that the other two approaches represent a better and more rigorous way and more appropriate approach for analyzing the impact of restaurant smoking bans than the direct sales method. Is that basically correct? And I'm going to suggest an explanation for why you may have concluded that. MR. GLANTZ: That's basically correct. MR. RUPP: The explanation that at least occurs to me as a possibility is that unlike the direct sales method, the two ratios permit you to take into account population growth, inflation, and changes in underlying conditions in a way that the direct sales method does not. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1708
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1 2 3 4 5 6 7 8 9 10 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 522 Is that reasonably accurate? MR. GLANTZ: Can you repeat the three reasons? I think it is, but I want to be accurate here. MR. RUPP: Population growth, inflation, and underlying economic circumstances. MR. GLANTZ: statement, yes. MR. RUPP: I would say that's an accurate Let's look at a couple of pieces of data from this chart, and this is Exhibit A. It depicts the results of all three of the approaches to the original data, and the regression analyses for each of the cities you examined. Because this does look like a little bit of a jumble, let's focus on a single city, and let's take Bellflower. MR. GLANTZ: MR. RUPP: Okay. First what you've done is you've taken a mean quarterly failed, that is the figure marked as $9,723,000. Three zeros have been dropped here. MS. JANES: Yes. That's correct. MR. RUPP: And those are sales figures averaged over the 22 quarters for which you had data. MR. GLANTZ: Yes. MR. RUPP: Then you showed whether the imposition of a smoking ban had a positive, negative, or indeterminate effect on restaurant sales, and as I understand it, that is BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1709
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 523 the column that's labeled BL, is that correct? MR. GLANTZ: Yes, Beta L. Right. MR. RUPP: Bellflower shows a negative value here of $1,103,000, and that figure suggests the presence of a smoking ban was accompanied by a reduction in retail sales, if that's the only figure you looked at. Correct? MR. GLANTZ: That's a misleading and irresponsible statement, because the next number, the standard air, the $811,000 is something that you have to take into account when assessing the first number. MR. RUPP: Right. We'll get along so much better if you can just answer the question. I said if you look at that figure alone, which would suggest that I was not going to look at it alone, you wouldn't have characterized it as irresponsible, would you? MR. GLANTZ: Well, if you just looked... MR. RUPP: Listen to the question that I ask and respond to it. All right? If you look at this figure alone, it suggests that the ban had a negative impact on the sales, does it not? MR. GLANTZ: If that's allyou looked at, yes. JUDGE VITTONE: Mr. Rupp, I don't want to interrupt, but when you say "the figure" I don't think the... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1710
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1 2 3 4 5 7 8 9 i0 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 524 MR. RUPP: I'm sorry. I stand corrected. The $1,103,000, standing alone suggests a decline in restaurant sales as a function of the ban in Bellflower, is that correct? MR. GLANTZ: MR. RUPP: Yes. In Beverly Hills, the positive value suggests that the presence of a smoking ban was accompanied by an increase in retail sales, is that correct? MR. GLANTZ: Yes. MR. RUPP: This figure, which starting with the base of $25 million some odd dollars, appears to increase by $2 million and the first (inaudible) is $1800. So it suggests standing alone an increase. MR. GLANTZ: If you ignore the standard air... MR. RUPP: If you ignore the standard air. MR. GLANTZ: All right. MR. RUPP: When you studied restaurant sales initially, as a fraction of total retail sales in the smoking city, the R-squared numbers fall quite decidedly, relative to the results that you got when you studied direct restaurant sales, did they not? MR. GLANTZ: I didn't understand the question. MR. RUPP: I'm not focusing on the R-squared column, which is the column, as I understand it, that in statistical terms describes for us the degree of explanatory BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1711
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1 2 3 4 5 6 7 8 '9 I0 ii~ 12 13 14 15 16 17 18 19 20 21 22 23 24 25 power, the variables built into the model has proven to have. So that the higher the number the closer it is to one, the more explanatory the model appears to have according to the R-squared figure. way? 525 MR. GLANTZ: That's not... Well... MR. RUPP: Would you like to explain that another MR. GLANTZ: Go ahead. MR. RUPP: My point here is, and I'm not making a qualitative judgment about whether leads are unacceptable or acceptable in scientific terms. I'm just saying they're getting lower as you move from model one which yoE projected perhaps for the reasons you described earlier, to model two, which is a fraction of the total retail sales, to model three, which is comparison of control cities and banned cities. The explanatory powers of the models appear, according to the R-squared numbers, to be decreasing. The R-squared depends on another thing. That is, it depends on the variance in the observations that are going into the computation, so the R-square isn't just the explanatory power of the variables. It also depends on the magnitudes of the numbers. That's why you look at an associated P value. MR. GLANTZ: Of course. The other thing which is important in terms of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1712
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 526 this line-of questioning, is that if in fact the model is not predictive of change, which is essentially the conclusion we drew here, a negative conclusion, then you would expect the R-square numbers to be small in fact. The fact that the R-square numbers are larger for the total sales than the other one is because the time is a very important variable because of inflation and the other issues that you mentioned, and that sort of artificially inflates the R-squared. That's one of the criticisms that several people made, including some of my colleagues, of using the total sales data, which is why we, in those subsequent studies, use the other approaches which you mentioned. MR. RUPP: There's another problem, is there not, or another series of problems, is there not, in connection with the use of control and banned cities that may explain the apparent loss of explanatory power in the model, and that is that the third of these models depends very greatly on comparability and demographic characteristics in terms of age and mix of population, extent of education, income level, commuter patterns, prevalence of smoking, number and mix of restaurants in the ban and the control cities. That is if you lose comparability there, if you're comparing apples and oranges, one would intuitively expect that your model wouldn't perform all that well. Isn't that correct? MR. GLANTZ: Yes, that's why we, in the final BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1713
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 527 publication that appeared in the American Journal of Public Health, if you compare the control cities we used in the original study, the one you're exhibiting here, and the final work we published, some of them were changed because people did raise that as an issue, and we put a lot more effort into trying to match the cities. MR. RUPP: But that's an extremely difficult task, I would say. MR. GLANTZ: If you look in the appropriate table in the American Journal of Public Health paper, I think we ended up with pretty good matches. It's getting harder as more cities pass ordinances, we're kind of running out of control cities, but that didn't affect the work that we published in the American Journal of Public Health. MR. RUPP: Have you ever compared the results .... MS. SHERMAN: Excuse me, Your Honor. Could we have a one minute recess? Apparently they're losing the recordability on the microphone, and they'd like to adjust JUDGE VITTONE: Can we do this in place, instead of everybody leaving? (Pause) JUDGE VITTONE: Back on the record, please. MR. RUPP: Thank you, Your Honor. Let's focus for a moment on the significance of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1714
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 528 using restaurant sales as a percentage of total retail sales, see how good that is and what the theory is being the notion. Again, to save time, let me tell you what my understanding is and you tell me if my understanding is basically correct. The premises that are motivating you to use that approach. Isn't it true that with or without a smoking ban, restaurant sales could change because the population might increase or there might be a recession? MR. GLANTZ: Yes. MR. RUPP: If the population grew, you'd expect an increase in restaurant sales, would you not? MR. GLANTZ: Yes, probably. MR. RUPP: And if there were a recession, you'd expect a decrease in restaurant sales. Correct? MR. GLANTZ: In total sales? Yes. MR. RUPP: So in the case of a change in population and economic conditions, restaurant sales and total retail sales should rise or fall roughly together, should they not? That was the premise, and the only reason one would try to relate this. MR. GLANTZ: Yes. MR. RUPP: And you expected, did you not, that there would be a reasonably stable relationship as you utilize what we'll call model two, a reasonably stable BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1715
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1 2 3 4 5 6 7 8 9 10 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 529 relationship between total restaurant sales and total retail sales. MR. GLANTZ: That's what we found when we analyzed the time period before the ordinances. One of the reasons we went back for at least five years before the ordinances passed to get our baseline was to estimate that, one of the reasons, was to estimate that affect and the underlying variability. MR. RUPP: Now I'm going to show you a second chart. Dr. Glantz, my friends at Price Waterhouse, what they've done for me here is they have arrayed the sales data, restaurant sales data and retail sales data for the city of Bellflower, California from 1986 through 1990 and that covers a period before the smoking ban was in effect. MR. GLANTZ: Yes. MR. RUPP: This chart shows the percentage change in Bellflower restaurant sales from quarter to quarter over time, and also the same things for Bellflower, total retail sales, right? MR. GLANTZ: That's correct. MR. RUPP: It comes from your data, it's presented in Table I, A-I of your original report. The problem I have with this as I look at it , is I do not see the expected stable or steady relationship. indeed, very often, restaurant sales go up when retail sales BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1716
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! 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 530 go down, and I'll give you a specific example of what I'm talking about. If you look, for example, at the first quarter of 1989, restaurant sales in Bellflower, before the ban, fell by seven percent, while retail sales rose by 15.9 percent, so we found ourselves with a gap of 22 percent. MR. GLANTZ: Yes, but Mr. Rupp, if you look at Exhibit B, you'll see that's very unusual. (The document referred to was marked for identification as Exhibit B.) MR. GLANTZ: In most cases they do track pretty well. And my guess is that if you were to comput~ the cross-correlation function over time of these two graphs that you presented, it would show reasonable concordance over time. You're really selecting,, obviously you've just presented this to me, but you've really selected the one and only point... Pardon me, there's one other point where there's a discordance, and that's the third quarter of 1993. All the rest of them tend to move together. MR. RUPP: Let me suggest to you, I'll accept what you've said insofar as I have, for illustrative purposes to begin, chosen one quarter that shows the largest swing, and that is a 22-23 percent swing. But do we need to go through some of the other swings to say that they are quite substantial? Ten, 12, 15 percent is not uncommon for BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1717
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! 2 3 4 5 6 7 8 9 l0 ii 12 13 14 15 16 17 18 19 20 22 23 24 25 531 a swing between restaurant and retail sales from quarter to quarter? MR. GLANTZ: The real issue is are these things cross-correlated over time. The other issue which is important in this, which isn't really seen in a graph like this, is what the standard error of that variability it, which decreases ad the number of data points increases. That's what determines the ultimate sensitivity of your study. MR. RUPP: Is it possible, Dr. Glantz, that this absence of a systematic relationship, what I believe to be a systematic relationship, or you can characterize it somewhat differently, but the absence of a, let's say total relationship, may be a partial explanation for the loss of explanatory power, your R-squares are s~owing as you move from model one to model two. MR. GLANTZ: I don't agree with that. I don't agree with your characterization of the data, and I don't agree with the conclusion you drew based on that characterization. MR. RUPP: MR. GLANTZ: In what respects do you disagree? The first way I disagree, as I mentioned, when you're looking at a relationship between two variables over time, you want to look at the cross- correlation between the two variables. The thing that's BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1718
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1 2 3 4 5 6 7 8 9 l0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 532 important-in terms of our model is that averaged over time, the standard error of the variation remain reasonably small. The second thing is that the lower value of the R-squared that was observed was, I think, largely due to the fact that the underlying inflation and population growth variables which you've talked about earlier, are essentially taken out when you compute the fraction of retail sales to the ratio of the comparison cities. So if you look at the individual coefficients in the regression model, which we didn't include here, the most that R-squared is attributed to time, in what you're calling model one. The reason 'for that, and in fact the reason that we stopped using the total sales in the subsequent studies, including the one I testified to today which is our current best study, was because the time variable, because of all the problems with the time variable that you have alluded to yourself. Many people suggested that we abandon that variable. So I'd have to go back and look at the actual statistics, but my guess is the big difference between the R-squareds in the three models has to do with taking out the time worth with the explanatory variances associated with the time variable because you have, by using fraction of total retail sales, to some extent normalized for population growth, underlying economic conditions, and inflation. MR. RUPP: Here's the problem I have with that BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1719
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 533 explanation. That would be all very good, I will argue, and you tell me why I would argue this in vain, if the bans that we're talking about existed over long periods of time. We're looking at Bellflower here. MR. GLANTZ: Yes. MR. RUPP: But if you look at Beverly Hills, you had a ban that was in effect for three and a half months. If you look at a number of other cities that are included in the various models that you performed, you also have short periods of time. So that a correlation over a five, six, seven year period that might give you a high correlation figure if you were to look at that, is pretty irrelevant, is it not? Because what's significant is the extent to which, without regard to anything happening with respect to smoking, within the pertinent time period, restaurant sales and total retail sales were tracking one another. And when you're looking at shifts of this sort, we looked at one of 22 percent, you've got a model that can't possibly do all that goo9 a job, giving you a snapshot over any constricted period of time, at what truly is going on. Where is that wrong? MR. GLANTZ: That'swhy we did the subsequent studies which collected a lot more data. MR. RUPP: We'll come to some of those data too. Let's continue, then, to look at Bellflower. Let BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1720
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 534 me ask you to focus on another aspect of the Bellflower data. Do you know the extent to which the total retail sales data in Bellflower reflect new automobile sales? MR. GLANTZ: I'm aware from Bob Rossi that there are significant automobile dealerships in Bellflower. MR. RUPP: It's an automobile dealer mecca, is it not? MR. GLANTZ: If you say so. I've never... MR. RUPP: Would you be surprised to learn that between 35 and 40 percent of total retail sales in Bellflower, in any given quarter, will be new automobile sales? MR~ GLANTZ: I can't testify to that one way or the other. MR. RUPP: Would you expect restaurant sales in Bellflower to track automobile sales with all that much closeness? I hate to use the layman's term, but... MR. GLANTZ: To the extent that automobile sales reflect the underlying economic conditions in the region, which is an important variable, especially in California, they'd be related. That may be what accounts for those two points which you've identified where there's the high level of discordance. MR. RUPP: Let me show you yet another chart, and this is the last of the new charts that I'll show you. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1721
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 535 Let me characterize this first, if I may, and then I'll give it to you and ask you whether you have any problem with that characterization. What i'm going to show you is a chart from Price Waterhouse that shows me for Bellflower during the period for which you've depicted data, total retail sales minus automobile sales, new car sales, and that line is wiggles up and down a little bit, but it's generally flat. And then I look at automobile sales alone during that period, and what I have are tremendous peaks and valleys showing that where you have a recession, automobile sales go very badly, while general retail sales don't necessarily reflect anything like the same kind of dip. (pause) MR. GLANTZ: question. If I can just ask a clarifying MR. RUPP: You sure dan. MR. GLANTZ: The index for auto dealers, what does that mean? MR. RUPP: Maybe I could prevail upon one of my colleagues to answer that question. On the basis of i00 percent for the first period... MR. GLANTZ: I didn't hear the answer. MR. RUPP: On the basis of i00 percent. Oh, excuse me, I now understand. Those figures are indexed. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1722
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 536 Those are-indexed with I00 percent being the starting period, then we're talking about percentage changes month to month. It was believed by us to be a way of showing changes from month to mont that would reveal exactly what was going on. So the i00 on the left hand side is not $I00 million or $i00 thousand, it's an index of $i00. MR. GLANTZ: Is that number based on the average over the period of interest, or is it simply the first quarter of 1991? MR. RUPP: The first quarter of 1991. We start where we had the data to start, and we indexed from that point on. The question I have for you on the basis of that... MS. SHERMAN: Just a minute, Mr. Rupp. Do you have a large chart so that we can... MR. RUPP: No, unfortunately, I do not. worked this one up. MS. SHERMAN: are talking about. MR.~RUPP: apologize for this. any possibility of your sitting with him for a moment? will avoid this in the future, you can be sure. (Pause) We just So we can't see what the two of you That is a problem. I really do It is the only one we have. Is there We BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1723
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 537 My thanks to Ms. Sherman for being so cooperative. The question I have for you on the basis of that chart, and some of the other discussion we've had is really a relatively simply one. Does not that chart indicate quite clearly that there's something conceptually quite wrong about your second, or misconceived about the second model and the one you've chosen to rely on, and the misconception is in this. Doesn't that reveal that we are trying to compare here apples and oranges. The factors that influence general retail sales are not necessarily at all the same factors that will affect restaurant sales, or to take a sub- part of that general question, the factors that influence automobile sales are not even the same factors that influence general retail sales in any given locality. MR. GLANTZ: I don't think this graph necessarily supports that statement. MR. RUPP: It's not an unreasonable view of the state of facts though, is it? MR. GLANTZ: I don't really care to have you put words in my mouth. If you go consult with the people who come see me about statistics at UCSF, I will tell them one problem with using percentages is that basically all these numbers are heavily influenced by one point. And if there was something strange going on in the first quarter of 1991, BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1724
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5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 538 that could heavily affect the results here. So I really can't reach any conclusions based on this. If you wish to, that's your prerogative, obviously. MR. RUPP: Okay, I appreciate that. MR. GLANTZ: But this graph is heavily conditioned on one number or two numbers. MR. RUPP: We'll have to be gentlemen and agree to disagree about that, won't we? MR. GLANTZ: Okay. MR. RUPP: Let me move on. Let's look now at the percentage changes in Bellflower restaurant and retail sales as we go from the 3rd quarter of 1989 to the 4th quarter of 1989. MS. SHERMAN: Which chart are we on? MR. RUPP: Exhibit C. (The document referred to was marked for identification as Exhibit C.) Let's look at Exhibit C. JUDGE VITTONE: Do you have another one for Dr. Glantz? MR. RUPP: Yes, we do. JUDGE VITTONE: It's getting close to 5:00 o'clock here. I can tell. What you'll see there, Dr. Glantz, as we look at the data, is that restaurant sales rose from $I0 million to BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1725
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 539 $Ii million during that quarter, while total retail sales fell from 87 to 82 million dollars. So restaurant sales rose 12 percent while retail sales rose by 5.9 percent, about an 18 percent swing in that quarter. MR. GLANTZ: I don't see... MR. RUPP: I'm asking you to look at the third quarter 1989 to the fourth quarter of 1989. I know this is a period well before the ban... Mr. Rupp. MS. SHERMAN: MR. GLANTZ: I think you have the wrong chart, The chart that you've given me only has one line on it. retail sales. MS. SHERMAN: 1989 on it. MR. RUPP: talking about B. There's nothing in here about total There's nothing in here that says So the record is clear, we're still MR. GLANTZ: I thought you were talking about C. I'm not very good with pictures, I guess. MR. RUPP: Just so it's clear, and I know you were searching for the right numbers when I was asking the question, so let me ask the question again. I'm going to ask you to look at the third quarter of 1989 to change to the fourth quarter of 1989. Restaurant sales rose from i0 million... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1726
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1 2 3 4 5 6 7 8 9 10 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 54O MR. GLANTZ: Wait, wait. Slow down. Which do you want me to look at? MR. RUPP: Third quarter '89 to fourth quarter. Restaurant sales rose there from $i0 to $ii million, while total retail sales fell from $87 million to $82 million, I'm rounding off. MR. GLANTZ: The graph, Exhibit B, doesn't have that information on it. MR. RUPP: No, it has to be computed, as a matter of fact, but what that computation shows is restaurant sales rose by 12 percent during that quarter while retail sales fell by 5.9 percent, whatever the reason. The observation I'm making, and I 'd ask you whether you have any problem with it, is that you can get very substantial quarter to quarter shifts in these figures that can be for a whole host of reasons, can you not? MR. GLANTZ: That's the issue that we were discussing previously. My guess would be, just looking on this, it's just cooperation. Obviously you just put this in front of me and I can't do statistics in my head. MR. RUPP: (Pause) MR. RUPP: Give me just a second, if you will. Assume with me, because I'm not going to sit there and ask you to do the calculations either in your head or with a calculator. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1727
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1 2 3 4 5 6 7 8 9 I0 iI 12 13 14 15 16 17 18 19 20 21 22 23 24 25 541 MR. GLANTZ: Thank you. MR. RUPP: But assume we have the 18 percent gap during that are from random fluctuations or some other reason. And assume that you had a restaurant smoking ban that was in imposed in the city of Bellflower at that point, immediately following the 18 percent gap. Just like Rosemarie Woods' 18 minute gap, okay? MR. GLANTZ: Right. MR. RUPP: You have the 18 percent gap. Let's assume that the imposition of the ban caused an 18 percent drop in restaurant sales immediately, reflected in sales throughout the quarter. Under your second model, you would show no change. That is, you would show that the ban had had no adverse impact because its effect was simply to bring restaurant sales back down into line with retail sales that had obviously dropped for some other reason, having nothing to do with smoking. Is that not correct? MR. GLANTZ: No, that's not a really accurate representation of the way the model works. MR. RUPP: You explain how it does work, then. MR. GLANTZ: For many of the reasons that you've been discussing, it's very, very difficult, I think, in fact I think impossible, to look at quarter to quarter changes. That's why we've looked at the data over a long period of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1728
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5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 542 time. WeJre looking for a net average in the effect of the ordinance. So we don't look at one quarter, we look at several quarters that the ordnance was in force. That's why it's your prerogative to ask these questions, but the study I testified to was the American Journal of Public Health version of this, which was based on much more data than we're discussing here, and we're really focusing in on simply one city rather than all 15 of them. MR. RUPP: I'm simply trying to understand how the model works. MR. GLANTZ: The important distinction between your understanding and what we actually did is that the model doesn't look at one quarter or another quarter. It looks at the period when the ordinance was in force, however long that was, and the period where it wasn't in force. It asks the question, on the average, was there a change above the underlying variability. MR. RUPP: But that's interesting, Dr. Glantz, because .in your testimony this morning as well as in your printed statement, you reached some fairly firm conclusions about the impact of the ban in Beverly Hills, California. How long was that ban in effect? MS. JANES: That ban was only in force for about a quarter and a half. MR. RUPP: Three and a half months. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1729
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 543 MR. GLANTZ: It slopped into two reporting periods. But if Beverly Hills had been all that we had, then I wouldn't be saying any of these things. But we actually were asked by the reviewers of the AJPH paper to exclusively test the hypothesis that there was a 30 percent drop, and we were able to reject that at the .001 level, despite the fact that for Beverly Hills there was very, very limited data. MR. RUPP: What you've just told me though is that, and I'm quoting, and it can be read back by the reporter if you have any doubts, that it is impossible to look at one quarter. One cannot reach conclusions on the ba sis of one quarter's data. I would have expected you to say that, and the reasons are these. MR. GLANTZ: You would or wouldn't have? MR. RUPP: Would have expected you to say that. And the reasons are these. All of those reasons we discussed at the beginning. The problems of the State Board of Equalization figures, the bar and restaurant lumping problem, the late and early filing problem. And while those may ease out over time, or may not, looking at data in a single quarter is a highly suspect approach, is it not? MR. GLANTZ: That's why we didn't look... If the only data we had had would have been Beverly Hills, we would have never published anything. But... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1730
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2 3 4 5 6 7 8 9 l0 ll 12 13 15 16 17 18 19 2O 21 22 23 24 25 544 MR. RUPP: Very specific claims were being made of a 30 percent drop in Beverly Hills. I showed a Tobacco Institute ad making that claim. Despite the low power associated with only having two data points, and the dummy variables are coded to account for part of the quarter being covered, we were still able to at the .001 level, reject the hypothesis of no change. IN addition, ~as I testified to, in the AJPH analysis, which was the final version of this that benefitted from a great deal of suggestions from people, we could have detected with 80 percent power, about half a percent change on average. So this is very much like the comments I was making about the epidemiology. It's very important to look at all the data. Now we can sit here and talk about Bellflower. Obviously you're... MR. RUPP: We're now talking about Beverly Hills. MR. GLANTZ: Or Beverly Hills as long as you want. But you need to really look at all the cities. I would not have published a paper on just Beverly Hills. MR. RUPP: It was originally published on four cities, was it not? MR. GLANTZ: That was all the data that was available. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1731
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 17 18 19 20 21 22 23 24 25 545 MR. RUPP: Why, in light of the statements that you've made, did you just not eliminate Beverly Hills from your computation? MR. GLANTZ: Because we didn't want to be accused of being selective in the data. We reported all of the cities that were available. MR. RUPP: When you say you could conclude with a high degree of certainty that there was no drop, you are ignoring, are you now, the lumping of bar and restaurant sales, and the reporting and data problems that we discussed at such great and laborious length at the beginning of our discussion. MR. GLANTZ: I don't think that's an accurate characterization. If you read our AJPH paper and many of the other things, we are cognizant of that as a limitation in the study. All studies have some sort of limitations. But if you go back and look at the slide which I prevented for Beverly Hills, you'll see that the points for the quarters that the ordinances -- when I say quarters, I'm talking about calendar quarters -- were in force, pretty much fell on the line, established by the underlying secular trend. For any of the alternative explanations that you're proposing to explain our results to be true, there would have had to have been, for example, a huge shift in BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1732
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 546 how much people were drinking. Or alternatively, one hypothesis that was advanced was that people suddenly started understating their taxes. That was one other alternative that was suggested. MR. RUPP: Another possibility is that people were having a shorter or smaller lunch in the bar area of the restaurant which had been expanded. Is that a possibility as well? It was under the law an option available to restauranteurs and... MR. GLANTZ: I don't know if people did that or not. I can tell you that the owner of Jacopos who is the restauranteur who is the nominal head of the Beverly Hills Restaurant Association, has written a letter to the New York City Council saying that the claim of the drop was fabricated, and he actually was smoke-free now, and regretted having anything to do with it. I'm aware of any affirmative evidence to support the assertions that you're making. MR. RUPP: I'm not making assertions, I'm asking questions. Let me ask you to look at Exhibit C, would you do that for me? MR. GLANTZ: MR. RUPP: Okay. I'm going to move away from the percentage stuff and we're going to look at restaurant sales BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1733
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 547 directly.- This chart shows Bellflower restaurant sales as reported by the SBE from the first quarter of 1986 through the third quarter of 1993. As you state in your reports, Bellflower imposed a 100 percent ban on smoking in restaurants, but not in bars, in March of 1991. That is at the end of the first quarter of 1991. MR. GLANTZ: Okay. MR. RUPP: The city repealed the ban in March of 1992 or the first quarter of 1992, isn't that correct? MR. GLANTZ: March would actually, yes, March is in the first quarter of '92 still, yes. MR. RUPP: When I look at Exhibit C, and I've marked here, focusing on overall sales within restaurants, what I'm finding is when the ban was introduced it was accompanied by a very substantial loss of sales, sales continued at a low level when the first quarter in which the ordinance was repealed, you have a very substantial upward move, and now we're focusing only on Bellflower, I understand that, and I'm not suggesting that the same happened elsewhere, it may or may not. Isn't this consistent with, and tend to show, a very substantial fall-off in sales with the imposition of a no-smoking law, even one that did not ban smoking in the bar area of restaurants and a very substantial increase in sales when the ban was taken away? BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1734
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 548 MR. GLANTZ: No. The reason for that is if you look after your second arrow, you'll notice that the sales continued to drop quite substantially after the ordinance was repealed, and if you look back to like the second quarter of 1987, third quarter of '87, you see similar big drops. So the change which you're pointing to between your two arrows could very well be simply underlying random variation or underlying economic conditions, because you can take this graph that you've put forward -- I wouldn't do this, but you could take the graph you've put forward and argue that repealing the ordinance made sales go down because the third quarter 1993 data is lower than ~he period the ordinance was in force. I wouldn't draw that... MR. RUPP: It's a very odd coincidence though, is it not? Here's another way of depicting the same data. This depicts Bellflower restaurant sales, change in sales, one quarter to the other, modeling them against the prior quarter in the... MS. SHERMAN: Mr. Rupp, do you have a copy of that exhibit that you're asking Professor Glantz to comment on? MR. RUPP: Excuse me? MS. SHERMAN: Have you a copy of... (Pause) MR. RUPP: What this would tend to do, I take it, BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1735
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 549 is ease out any problems that were simply a function of seasonality in the restaurant business, because now we're comparing like quarter with like quarter. MR. GLANTZ: It would deal with some of the seasonality. There are many other of the important issues that you raised aren't handled with this kind of a correction. MR. RUPP: Yes, and Ms. Sherman reminds me that I should identify this again as Exhibit D. (The document referred to was marked for identification as Exhibit D.) MR. GLANTZ: Yes. MR. RUPP: Maybe this is a coincidence, maybe it's not, but what you find here is during the period the restaurant smoking ban was in effect, but not a ban in smoking in bars, what you found in the. city of Bellflower was a very significant decrease in sales overall. From one quarter to... When one compares the ban year against the non-ban year, or the ban quarter against the comparable non- ban quarter of the preceding year. Do you not? MR. GLANTZ: Of course, Mr. Rupp, you can draw whatever conclusions you want from this. I would not... Again, you're presenting me with these data. I don't have time to do a formal analysis. But looking at this graph, and based on our analysis, this could very well be a BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1736
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 55O reflection of underlying variability. I think you could use these same data to make the following. I wouldn't do this again, but I think you could argue that repealing the ordinance was bad for business because in two of the subsequent quarters to repealing it, you had even bigger drops in business. The other thing that's important to realize is that in the period in question, the California economy was in the tank. I know that very well, because my salary got cut because of it at the university. And this may well be reflecting the underlying economic problems of California. MR. RUPP: And it was certainly reflected in the automobile sales during those... MR. GLANTZ: It's hard to read, but if you look at the 1987 second, third, and fourth quarters, you see comparable drops. MR. RUPP: Absolutely. MR. GLANTZ: So my looking at this would say the theory that you advance is one theory one could advance. It's not clear to me that the changes you're observing here are more than the underlying variability. MR. RUPP: But it's an interesting coincidence, is it not? MR. GLANTZ: Yes, there are many coincidences. MR. RUPP: There are, indeed. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1737
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1 2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 551 Let me ask, and we're almost near the end, you'll be happy to know that. MR. GLANTZ: MR. RUPP: I'm okay. Let me ask you to look at these exhibits, and again, there are a great many numbers, and... MR. GLANTZ: MS. SHERMAN: read that, Mr. Rupp. That I cannot read from here. There's no way that anybody can look at. can see. MR. RUPP: There are only two numbers we have to These are charts from your papers. MR. GLANTZ: This is correct. At least the one I MR. RUPP: I think you'll see that the next one is as well. Ad I've labeled these for the record Exhibit E(1) and Exhibit F(2) for reasons that will be obvious to know. (The documents referred to were marked for identification as Exhibit E(1) and F(2).) MR. GLANTZ: Yes. MR. RUPP: Exhibit E(1) and Exhibit F(2), and I'm going to refer first to Exhibit E(1). I'd ask you to focus on Beverly Hills, and the number 21651. That, I take it, shows total bar and restaurant sales in Beverly Hills during the first quarter of 1987. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1738
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 552 I take it that that figure is designed to be a summation of these three figures from Exhibit F(2). 1748, 5234, and 18165. Are they not? Is that correct? MR. GLANTZ: Exhibit F(1) doesn't have Beverly Hills on it. MR. RUPP: Excuse me, I'm asking you to compare E(1) with F(2). MR. GLANTZ: I don't have F(2). (Pause) MR. GLANTZ: I have E(1) and F(1) right now. MS. SHERMAN: Here's E(2) and F(2). (Pause) MR~ RUPP: E(1) and F(2). MR. GLANTZ: Okay, that makes sense. MS. SHERMAN: I thought you had given me two complete sets, and you didn't. MR. RUPP: I thought I did, too. JUDGE VITTONE: Do you want to sit here? MR. RUPP: If you'll do that one more time, I promise you we are very near the end of this. Dr. Glantz, again, my question is this. This 21651 figure is supposed to b~ a summation from Exhibit E(1), a summation of the three figures on Exhibit F(2) of 1748, 5234, and 18165. Is that not correct? MR. GLANTZ: If it's not, it's another BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1739
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! 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 553 typographical error. I can testify that the sum that was used in the analysis is correct. MR. RUPP: I think the sum that you used in the analysis was 21651, while the correct figure, as we compute it, is 25147. The reason this is significant, of course, is that this is the quarter in Beverly Hills immediately preceding the ban. MS. SHERMAN: Mr. Rupp, the figures will add... MR. RUPP: No. MS. SHERMAN: ...as they'll add. MR. GLANTZ: This is an important point. This is a testament to the fact that I don't proofread. The way we did this, and this is very important, was at least in these three, the three sub-numbers which are on F(2) were entered into the computer and then the computer was told to add the numbers up, and the computer sum is the number that was used in the statistical analysis. Now if in the process, so that the number that we have in the statistical analysis was actually the sum of these numbers. Now whether the 21651 number is a typo or one of these other three numbers has an error in it, that I can't tell you. But I can tell you that the number which was used in the analysis, these things did add up the way they were supposed to because we used a computer to do the addition. Unfortunately, we didn't have a way to print that BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1740
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2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 554 Out in a way that we could reproduce, so all these numbers had to be manually typed in. This is an embarrassing point that we didn't proofread these numbers. MR. RUPP: Let me look at another, and I don't mean to embarrass you, but I'm trying to make points of significance. Embarrassment is not one of them. MR. GLANTZ: I don't see this as a significant issue. MR. RUPP: All right. Let me ask yoU to look at the number that I'm going to point to now at the bottom of E(1). The number is 21673. Would you tell me whether that number is correct? To do so, you'd have to look at Exhibit F(2). MR. GLANTZ: The only way to answer whether that number is correct, I can't do that here. It's to go back to the raw data files and cross check the numbers that are in there with the numbers that are printed here, and I can submit that in a post-hearing... MR. RUPP: One or the other is wrong, isn't that obvious? MR. GLANTZ: There was a typo on one of those two numbers. But the important point, and I really want to stress this, we did not take the numbers off these pages for the actual statistical analysis. Those were in the BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1741
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 555 computer,-were very, very carefully checked, and we printed them out on a line printer and had a secretary copy them. We thought we had caught all the typos. MR. RUPP: There, undoubtedly, Dr. Glantz, will be a good deal more discussion about the economic impact of a possible smoking ban in restaurants or various kinds of restrictions, and you will have opportunities to weigh in on that debate, as will others. Let me ask two concluding questions and try to draw you out in your thoughts. The first is this. Given the cities that you've looked at which are three ski resorts in Colorado and a number of the cities in California, do you believe that it's possible to generalize those results so far as the impact of smoking bans, including smoking bans that are complete restrictions, that is bans both in the restaurant area as well as the bar area, both within California and Colorado and to the rest of the country? That is, do you believe you've seen enough, it's just really quite clear. If OSHAdecides to ban smoking in restaurants, there will not be a single customer.who will refuse to go into restaurants, smoking customer who will refuse to go into restaurants at that point. Is that the position you're taking? MR. GLANTZ: You've made several statements that I don't necessarily agree with. In particular, that not a BAYLEY REPORTING, INC. (202} 234-7787 (800) 368-8993 TI1011-1742
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1 2 3 4 5 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 556 single smoking customer would go into a restaurant. That may happen. It also may happen that non-smoking customers will start going into restaurants. Based on the evidence which is available to us at this point, which is all the available data that we could locate, and given the tremendous variability in ahe cities that we analyzed in terms of rural versus urban in terms of socioeconomics in terms of underlying smoking rates, and given the power of the study as we published it in the American Journal of Public Health, which I think is our best analysis of this, not this first pass, I think there's no evidence that this will be bad for business. MR. RUPP: But the model that you've used and that we've spent such a great deal of time talking about is the same model that's used throughout, isn't it, including the most recent publication? MR. GLANTZ: Yes. MR. RUPP: So whether those models are good models or bad models, we can tell from our discussion that we've just gone through that people ultimately will decide who's right about it, correct? MR. GLANTZ: That's correct, and I think they're good models. They also passed the peer review system twice, once in this preliminary report through the Institute for Health Policy Studies, and then through the American Journal BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1743
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 557 of Public-Health. The reviewers found this a reasonable thing to do. Although the early version, there were several criticisms of using the total sales for the reasons we've discussed, which is why we've gone to the other approach, which was sent to people who have no interest in this issue whatsoever, especially by JPH, and it passed that hurdle. MR. RUPP: Is outdoor dining as viable an alternative, outside of California as it is inside California 12 months per year? MR. GLANTZ: I just had lunch outdoors today. MR. RUPP: It's summer in Washington, I'll have you know. MR.. GLANTZ: I'll accept that for the record. The one thing I can tell you living in California is that relatively few of the restaurants that I frequent, and even in San Francisco, which has a very temperate climate, have outdoor dining areas. MR. RUPP: Do you know the percentage of outdoor dining seating in California, or outdoor restaurant sales as a percentage of total restaurant sales? MR. GLANTZ: No, I don't. MR. RUPP: It would be an interesting point to pursue though, wouldn't it? MR. GLANTZ: I don't really think it would make too much difference. I've traveled quite a lot, and the BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1744
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! 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 558 restaurants that I see in San Francisco, the makeup of them isn't all that different. A significant fraction of people eat in places like Denny's and McDonald's and fast food places which are not all that different in California. Plus, when people talk about California they think about Los Angeles. But we also have the Sierras. In San Francisco it rains if we're not having a drought, four or five months a year, which makes outdoor dining not possible or it's very cold. It's freezing. I don't know about today, but when I left it was freezing there. So I don't think that... Let's put it this way. I haven't seen any affirmative data that would convince me that that's a significant problem. MR. RUPP: Your Honor, thank you very much for your patience. JUDGE VITTONE: Thank you, Mr. Rupp. MR. RUPP: And also to you, Ms. Sherman. MS. SHERMAN: Mr. Rupp, can we get together some hard copy of this? MR. RUPP: We certainly can. So we don't take up everyone's time in the room, I will stay after the hearing, Your Honor, and we can make sure that we have the various exhibits sorted and copies are made. They are numbered in a way that's appropriate for the Reporter, and we can present you a complete package in the morning. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti 1011-1745
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 - JUDGE VITTONE : Mr. Grossman? MR. GROSSMAN: I would appreciate that. 559 Your Honor, could we take a two minute break before we begin? JUDGE VITTONE: Certainly. (Whereupon, a brief recess was taken.) JUDGE VITTONE: We're back on the record. MR. GROSSMAN: I want to read into the record a complete list of those for whom I'm asking questions. JUDGE VITTONE: you mentioned yesterday? MR. GROSSMAN: JUDGE VITTONE: for the record. MR. GROSSMAN: In addition to some of the people Yes, the list is more complete. Mr. Grossman, identify yourself I'm Ted Grossman. I'm here on behalf of R.J. Reynolds under Dockets No. 170 and 200; the National Licensed Beverage Association under Docket 229; the Ohio Licensed Beverage Association under Docket 221; the Licensed Beverage Association, Docket 141; the Oregon Smokers Rights Group, Docket 28; Sara Mahler, No. 191; William Pfeffer, Jr., Docket No. 60; L. Susan Alsop, Docket No. 232; Fay de Everhart, Docket No. 237; Roth Associates, Inc., Docket No. 77; and ChemRisk, Docket No. 204. Dr. Glantz, I listened carefully as I could to your testimony earlier, and I believe you said that it is BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1746
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 56O your belief that there is no evidence of a threshold of risk for exposure to ETS, is that accurate? Excuse me, Dr. Glantz. Is Ms. JUDGE VITTONE: Sherman still here? started. MR. GROSSMAN: Yes. MR. GLANTZ: I'd appreciate it if she was here... MS. SHERMAN: I'm sorry. JUDGE VITTONE: Ms. Sherman, we're getting MR. GLANTZ: Could you repeat the question? MR. GROSSMAN: Certainly. Dr. Glantz, it's accurate to say that you testified earlier that you believe there is no evidence of a threshold for risk to ETS? MR. GLANTZ: Yes, that's my belief. MR. GROSSMAN: By that you mean that no matter how dilute ETS, presents a health problem? MR. GLANTZ: If there was one molecule of a compound in each, yes, around that would be a much smaller health problem than if there was more of them, but there is no evidence that I'm aware of of a threshold affect for cancer, and I think that our evidence on heart disease is consistent with that. MR. GROSSMAN: You're referring to a threshold both in the concentration of ETS and the environment and as BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1747
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 561 to the length of time to which one is exposed to ETS? (Pause) MR. GROSSMAN: Is that correct? MR. GLANTZ: I'm just thinking about it. (Pause) MR. GLANTZ: I would say based on current theories of carcinogenicity, yes. MR. GROSSMAN: Based upon your view that there is no threshold as to either time of exposure of concentration of exposure, I gather you support a total ban on smoking in restaurants? (Pause) MR. GLANTZ: My reasons for supporting the OSHA regulation in general is that that's proved to be the simplest, most effective way to eliminate the risks associated with passive smoking. MR. GROSSMAN: smoking in restaurants? MR. GLANTZ: So you support a total ban on I support the rules as proposed by OSHAwhich involve restrictions. MR. GROSSMAN: One of the restrictions as of now is a total ban on smoking in restaurants. MR. GLANTZ: That's your characterization. OSHA, I thought, was very careful to present an alternative characterization. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1748
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2 3 4 5 6 7 8 9 l0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 562 - M~. GROSSMAN: Let's go to another point, if you want to quibble over that, and I think it is a quibble. Dr. Glantz, you support the OSHA regulation that would prohibit anyone from working in a room dedicated to smoking, is that correct? MR. GLANTZ: Yes. There are some exceptions, reasonable exceptions in the OSHA rules. MR. GROSSMAN: Could you identify one for me? MR. GLANTZ: People are allowed in those rooms when there is not active smoking going on, as I understand the rule. MR. GROSSMAN: Only for the purpose of cleaning the room, is that correct? MR. GLANTZ: That's my understanding. MR. GROSSMAN: So far as you understand, the regulation and it was testified to yesterday, I believe you were here when OSHA was testifying as to the regulation? MR. GLANTZ: I heard about half their testimony. MR. GROSSMAN: The regulation requires that if a company dedicates a room to smoking work cannot be conducted in that room except that people can come in and clean the room when smoking is not going on. That's your understanding, isn't it? MR. GLANTZ: Yes. MR. GROSSMAN: And you support that regulation? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI 1011-1749
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 563 - MR. GLANTZ: Yes. Subject to any amendments they may make in light of this hearing, and then I'll have to see whether I like what they produce. MR. GROSSMAN: But as of now you support a regulation that would prohibit individuals to smoke in their own offices with the door closed. MR. GLANTZ: Yes. MR. GROSSMAN: That's because.you believe that by smoking in their own offices they are nonetheless, polluting the environment of others around them? MR. GLANTZ: Yes, as long as there's a shared building ventilation system. MR. GROSSMAN: Apartment buildings also share building ventilation systems, is that correct? MR. GLANTZ: I'm not an expert on ventilation systems. I came to testify about passive smoking and heart disease in our restaurants. MR. GROSSMAN: You have been in apartment buildings that have shared ventilation systems, haven't you? MR. GLANTZ: I don't really know. When I've gone to apartment buildings I haven't checked out the ventilation. MR. GLANTZ: You haven't checked out the ventilation in office buildings either, have you? MS. SHERMAN: Your Honor, I think he's arguing BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1750
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 with the witness. The witness has already said that he doesn't have any knowledge or opinion about apartment building ventilation. MR. GROSSMAN: MS. SHERMAN: MR. GROSSMAN: witness' testimony goes. JUDGE VITTONE: I'm trying to... Can we move on? I'm trying to see where this 564 He's a layman in this area. MR. GROSSMAN: MR. GLANTZ: (Laughter) Well, he said he's not an expert. You stay in hotels, don't you? Yes. I attempted to last night. MR. GROSSMAN: Some of them have central ventilation, is that correct? MR. GLANTZ: I'M not an expert on ventilation. MR. GROSSMAN: Have you ever been in a building that had vents to a central ventilation system? MR. GLANTZ: The University of California UC Hospital does. And in fact, despite the fact that the air intake to that ventilation system is on a very windy hill, they've not put a no smoking sign up out on the street because people inside were complaining about the ETS being drawn in from the street, which I found quite remarkable. So that one building did. But I really think... I'm happy to do my best to answer your questions, but I am BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1751
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 565 not a ventilation expert. MR. GROSSMAN: I'm not asking you to be a ventilation expert, and I don't expect that you are one. I'm not suggesting that you are one. But so long as individuals, so long as a building has a shared ventilation system, you believe that any smoking in the building constitutes a hazard to others in the building, is that correct? MR. GLANTZ: To at least some of the people, yes. We had an example at our hospital which in fact was one of the precipitating events that led it to become smoke-free, where a patient was having a very hard time with ETS exposure from someone smoking in a room up the hall on the shared ventilation system. Chancelor's wife. MR. GROSSMAN: She happened to be the Vice It doesn't make any difference whether the building is used for work, for leisure, or as a residence. MR. GLANTZ: I'M not an expert on ventilation, sir. MR. GROSSMAN: I'm saying if it's the same building with the same ventilation system, people smoking in the building constitute, in your testimony, a hazard to others, whether the building is used for work, for a residence, or for leisure, isn't that correct? BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1752
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 566 MR. GLANTZ: My views on this are based on reading the general scientific literature and speaking to experts. Your Honor, I'm very uncomfortable being asked... I'm here as an expert, and one of the things I've learned is that you express strong opinions about things you know about, and you don't answer questions about things you don't. Now I can speak as someone who walks around, and whether or not I was in a room that had a radiator or not, but I don't really think I'm qualified to answer the questions you're asking, sir. MR. GROSSMAN: I think anyone in the United States is qualified to answer the question I'm asking, which is... MS. SHERMAN: Mr. Grossman, don't you think that it would be more useful if you asked these questions of somebody who knew something about this issue? MR. GROSSMAN: I'm trying to test Dr. Glantz's testimony. He says there is no threshold and he supports your regulation. MR. GLANTZ: Yes. MR. GROSSMAN: I'm simply trying to find out whether there's any difference in his opinion between exposure in the workplace... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1753
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 567 MS. SHE~4AN: Because scientific... MR. GROSSMAN: You're cutting me off. JUDGE VITTONE: Ms. Sherman, let him get his statement out, then I will make a ruling, okay? MR. GROSSMAN: I am simply trying to find out whether he believes that there is any material difference between exposure to the same molecules, as he puts it, in the work place, or any place else in our environment. Now Dr. Glantz, it doesn't make any difference to you... doctor? JUDGE VITTONE: Do you understand the question, MR.. GLANTZ: That's not a question about ventilation, and yes, I would agree that if you're exposed to a certain toxin, a cardiotoxin, when it gets to your heart or your blood vessels or your platelets, those platelets don't know whether you were in a building, in a house, or standing on Mars. The material has arrived at the target site for action. MR. GROSSMAN: It is possible in your view, to be exposed to ETS out of doors as well as indoors, is that correct? MR. GLANTZ: Yes. MR. GROSSMAN: There have been some efforts to preclude smoking in certain outdoor places in California, BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1754
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 568 and you have supported that, is that correct? MR. GLANTZ: Yes. There are certain outdoor environments, and I think it's not just been California, like stadiums, where even though it's open to the air, you have very strong micro environments, and flow patterns, and I believe that that's been one of the reasons that people have... Plus general public pressure, have made stadiums smoke free, which I think is a good idea: Again, I'm not an expert on local air flow patterns at Candlestick Park, other than knowing it's cold there. MR. GROSSMAN: I understand that, but I'm just trying to find out if you believe that exposure to ETS outside a building constitutes a health risk. MR. GLANTZ: It is possible. MR. GROSSMAN: In a work environment where smoking is not allowed int the building and where there is no dedicated room under negative ventilation set aside for smoking as a leisure activity, I believe the regulations presume that people will smoke outdoors of the building. I'm sure you have been past buildings that have no smoking policies, with many people smoking outside the building. You have seen that... MR. GLANTZ: MR. GROSSMAN: Oh, yes. Do you believe that standing BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1755
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 569 outside the building where many people are smoking, immediately outside the building where many people are smoking, constitutes a potential health risk? MR. GLANTZ: It could. It depends on the specific local micro environment. The fact is, you can simply walk past that place. MR. GROSSMAN: How about at a bus stop? MR. GLANTZ: It depends on where the bus stop is. You're asking me to testify about matters of which I am not an expert. layman... an expert. MR. GROSSMAN: MR. GLANTZ: Let me put it to you this way .... If you'd like my opinions as a MR. GROSSMAN: No, I'm asking you your opinion as You testified earlier that you believed that there are 30 to 50,000 cardiovascular deaths a .year .... MR. GLANTZ: Thirty to 60. MR. GROSSMAN: Thirty to 60, attributable to ETS, is that correct? MR. GLANTZ: Yes. MR. GROSSMAN: That wasn't limited to the workplace was it? MR. GLANTZ: That was based on total exposure everywhere. Now it is my understanding that the OSHArisk BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1756
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2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 570 estimates-are limited to workplace exposure. MR. GROSSMAN: But your testimony was not limited to the work place, is that correct? MR. GLANTZ: My testimony was addressing the question of is there good and compelling evidence that passive smoking causes heart disease, and I based it on the totality... MR. GROSSMAN: And as part of the testimony that you offered, you offered a number of the proposed, a certain number of deaths per year. AS a result of cardiovascular problems resulting from, you believe, exposure to ETS. MR. GLANTZ: Yes. MR. GROSSMAN: Those exposures that you're referring to are not only exposure in the workplace but outside the workplace. MR. GLANTZ: Yes. MR. GROSSMAN: Some of those exposure take place in the home, is that right? MR. GLANTZ: Yes. MR. GROSSMAN: Some of those exposure take place in social encounters, is that correct? MR. GLANTZ: A small fraction, yes. MR. GROSSMAN: Some of those exposures take place out of doors, is that correct? MR. GLANTZ: A small fraction. BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1"757
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 571 MR. GROSS~.~AN: Some of those exposures take place in transit, in cars, is that correct? MR. GLANTZ: That's correct, but the time budgeting studies which have been done have shown that the three primary sites of exposure that account for almost all of it, are work places, homes, and restaurants. MR. GLANTZ: Petty Jenkins, who I believe is one of the witnesses, has done some very good work on this and she can give... What I know about this work is mostly what she's told me. I wouldn't... ~MR. GROSSMAN: As you see it... MR. GLANTZ: I would say on a population, again, speaking as a layman, on a population basis, the bowling alley for bowlers is a relatively small fraction, and I believe Peggy may even have data on that. I'm not sure. But her data are quite clear. The workplace, restaurants, and the home are the three main sites of exposure. MR. GROSSMAN: Don't the data referred to by the OSHA Federal Register citation also refer to social encounters in general? MR. GLANTZ: In reading the 0SHA submission, I concentrated on the areas of my expertise. I don't recall exactly what they said. MR. GROSSMAN: You view ETS as a societal problem generally, is that correct? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1758
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 572 - MR. GLANTZ: All air pollution is a problem which is dealt with at a societal level. MR. GROSSMAN: One aspect of that as you see it is ETS, is that correct? MR. GLANTZ: In fact ETS is a very major source of toxic chemical exposure in air pollution for most people. Much worse than exposure outdoors in general. MR. GROSSMAN: And you view it as a societal problem? MS. SHERMAN: I believe that question's already been asked. MR. GROSSMAN: Yeah, but it wasn't answered. It's a simple.yes or no. You view the question of ETS exposure as a societal problem in general, isn't that correct? MR. GLANTZ: I believe that the question of regulating exposure of people to toxins is something we deal with at a society level. hearing today. MR. GROSSMAN: That's why we're having this If you could have your 'druthers, would you ban all smoking? MR. GLANTZ: No. MR. GROSSMAN: Where would you allow it? MR. GLANTZ: I would allow people, smoking be something engaged in by consenting adults in private, where BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1759
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l 2 3 4 5 6 7 8 9 10 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 573 they won't hurt their children or other people, and in fact that's what's happening in large parts of the country. MR. GROSSMAN: What does private mean? MR. GLANTZ: To where people are not involuntarily exposed. MR. GROSSMAN: MR. GLANTZ: MR. GROSSMAN: MR. GLANTZ: Where is that? I don't know. Well... For example in California today, according to John Piersons' data, half the households occupied by adult smokers are now smoke-free. There is no law or rule compelling people to do that, but as parents have come to appreciate that their smoking is hurting their children, they've chosen to smoke away from it. MR. GLANTZ: What question are you asking? MR. GROSSMAN: I'm asking what do I mean by private. And in this case... MR. GLANTZ: No, that wasn't the question. MR. GROSSMAN: ...going into the back yard. MR. GLANTZ: That wasn't the question. JUDGE VITTONE: Ask your question. MR. GROSSMAN: The question is, where would you allow smoking so as not to subject others to the risks that you believe they are subjected to? MR. GLANTZ: I think I've answered that question. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1760
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6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 MR. GROSS~.IAN: Where? MS. SHERMAN: He already answered it. not like his answer, but I believe he said... 574 You might MR. GROSSMAN: Could you identify the types of places where people could smoke as you see it, so as not to subject others to risk. MR. GLANTZ: Well one thing people have been choosing to do in California is smoke outside, away from other people. MR. GROSSMAN: In areas outside where other people are not around? MR. GLANTZ: I don't know the answer to that question exactly, how people are doing it. MR. GROSSMAN: I'm not asking you how people do it. I'm asking you as an expert, remember you said before you were comfortable only answering questions as an expert. MR. GLANTZ: Yes. MR. GROSSMAN: I'm asking you a question as an expert who offered the opinion that there is no evidence of a threshold for ETS exposure risk. Where people can smoke without subjecting, in your opinion, others to risk. MR. GLANTZ: I think the suggestion made by OSHA is a good one, separately ventilated smoking areas. They have them at the San Francisco airport, for example, when I flew out here. I think going outside, away from non-smokers BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1761
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 575 is fine. -I'm sure there are many other ways that smokers could accommodate to this. MR. GROSSMAN: Outside, away from non-smokers. MR. GLANTZ: Yes. Or in ways that non-smokers are not involuntarily exposed. MR. GROSSMAN: So you believe that the outdoor environment should be regulated to an extent, too, that there should be smoking areas outside as well as inside? MR. GLANTZ: No, I've never advocated... MR. GROSSMAN: I'm not asking whether you're taking an advocacy position, I'm asking you as a scientist, whether you believe it is appropriate, whether it would limit the risk of others to have outdoor, non-smoking and smoking areas. JUDGE VITTONE: Dr. Glantz, if you've never thought of the question, answer it that way. I'm not trying to prompt you to give an answer, but... MR. GLANTZ: It's not an issue I've really considered as an expert. When people have asked me do I think we should outlaw smoking outdoors which some politicians have suggested, I told them I thought it was not necessary. But that's not the question you're asking. I haven't really thought about that issue. MR. GROSSMAN: Let me just see if I can clarify a statement that you made in your earlier testimony that I BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1762
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 576 think may-have been in unintended error. Do you recall you were talking about risk ratios, confidence levels, and the rules of chance? MR. GLANTZ: MR. GROSSMAN: and the rules of chance. that regard? Pardon me? Risk ratios, confidence levels, Do you recall your testimony in MR. GLANTZ: Yes. MR. GROSSMAN: You suggested that a confidence level is intended to limit the likelihood that a cause and effect relationship... I'm sorry, let me start that again. Was it your testimony that a confidence level demonstrates for the rules of chance a cause and effect relationship? MR. GLANTZ: No. That all by itself is not sufficient. MR. GROSSMAN: I thought you left that implication, and I wanted to clarify that. The fact that the lower limit of a confidence level is over one, does not demonstrate a cause and effect relationship, is that correct? MR. GLANTZ: No observational study taken alone does that. What I testified to in terms of ETS and heart disease, is that there's a long chain of evidence running from test tube experiments through epidemiology studies BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1763
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1 2 3 4 5 6 7 8 .9 i0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 577 which come together and support the conclusion that there's a causal relationship. MR. GROSSMAN: By itself, the epidemiology is not something upon which you would rely... MR. GLANTZ: Pardon me? MR. GROSSMAN: By itself, an epidemiological relationship is not something on which you would rely to establish a causal relationship. MR. GLANTZ: That's not an accurate representation of my view. There are times that the only evidence you have available is the epidemiological evidence. The thing that makes the heart disease case particularly strong is that in addition to the epidemiological data we have the experimental biochemical and clinical data that I summarized, so it makes the case much, much stronger, but I believe it is possible to draw causal conclusions from epidemiology if appropriate. It depends on the specifics of the case at hand. MR. GROSSMAN: The fact that a confidence level is over one, the lower limit of the confidence level is over one, does not demonstrate through the rules of chance or otherwise, that an exposed population necessarily has an incidence of disease relating to its exposure, isn't that correct? MR. GLANTZ: No, I don't think that's a true BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1764
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 578 statement~ It does demonstrate that there is a relationship between exposure and the presence of a disease, above what you would expect from chance. MR. GROSSMAN: Let's look at an example. Are you familiar with the statistical relationship between smoking and cirrhosis of the liver? MR. GLANTZ: No. MR. GROSSMAN: Let me represent to you that there is a strong correlation between smoking and cirrhosis of the liver, and that it's a dose-dependent relationship. That doesn't suggest though, doctor, that smoking causes cirrhosis of the liver, but rather it relates to ~he confounder that people who smoke heavily often drink heavily, isn't that correct? MR. GLANTZ: That's a correct statement, and that's why in the heart disease studies controlling for the confounding variables, particularly age, I think, is very important. I think the evidence, as I said earlier, that Judd Wells has developed and published, that the more confounders you control for, the stronger the relationship gets is particularly important here. Confounding can go in both directions. It can do as you suggested or it can obscure a real relationship, too. MR. GROSSMAN: But it is, indeed, important to control for confounders and to control for all confounders. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1765
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 579 MR. GLANTZ: No, not all. The better the study is, the more of the potential confounding variables you account for, but the fact that something is a potential confounder doesn't mean that it's a problem. It could be, and a good study, the better the study is the more of those confounding variables will be controlled for. Again, Wells showed that the better the studies were, the stronger the risks were for ETS and heart disease. MR. GROSSMAN: Doctor, you travel widely? MR. GLANTZ: Now and then, yes. More than I want. MR. GROSSMAN: As part of your work, attending conferences or otherwise, you've traveled abroad? MR. GLANTZ: Yes, MR. GROSSMAN: MR. GLANTZ: MR. GROSSMAN: MR. GLANTZ: And have you traveled to Asia? I was in Japan twice, yes. Have you traveled to Europe? Yes. MR. GROSSMAN: Have you noticed the level of public smoking in Japan? MR. GLANTZ: When you go to these meetings they lock you in a hotel, and I was at the World Conference on Smoking and Health where environmental tobacco smoke wasn't a problem. And I noticed that they had non-smoking cars on the trains and the planes and subways, which I sat in. So BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1766
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 58O really can't comment upon that. I've read that there's more of it, but my direct experience, I managed to avoid it. MR. GROSSMAN: And in Europe the same would be true? You've managed to avoid public smoking in Europe? MR. GLANTZ: In Europe, I've only been to Europe once in recent years, and we went to one restaurant. But again, I was there lecturing at a university and there was no smoking in the lecture halls, and I was lecturing eight hours a day. I would say that there are fewer restrictions on smoking, public smoking in Japan and Asia and Europe than there are in parts of the United States. I think that's generally appreciated. MR. GROSSMAN: There are fewer restric6ions on public smoking in Japan, parts of Asia and Europe, and there's also a great deal more smoking in Japan than in the United States, isn't that correct? MR. GLANTZ: Again, you're moving me into an area where I'm not an expert. It is my recollection... I'd rather not get into that because it's a complicated question. There are differences between men and women, there are differences between prevalence and consumption among smokers, and I think those are important variables. I know enough to know that I really... You should talk to someone who is an expert on differential smoking rates BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1767
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 581 between countries, I think. MR. GROSSMAN: Let me represent to you the statistics of the U.S. Surgeon General and the Ministry of Health and Welfare of Japan on rates of smoking. In Japan in 1985, the 1985 numbers are the most recent statistics available for both the United States and Japan in the same year. 1985, 33.2 percent of American men smoked, adult men smoked, over the age of 20. MR. GLANTZ: Could you repeat that? MR. GROSSMAN: In 1985, 33.2 percent of American males over the age of 20 smoked cigarettes~ MR. GLANTZ: American males? MR. GROSSMAN: American males. 33.2 The number in Japan was 64.6 percent of all Japanese males over the age of 20 smoked. If one goes back to 1955, 52.6 percent of American males smoked; and 81.4 percent of Japanese males smoked cigarettes. You said earlier that you were familiar with an author, doctor, named Takisi Hirayama? MR. GLANTZ: Yes. MR. GROSSMAN: You're also familiar with Ernest Wynder and his writings? MR. GLANTZ: Yes. MR. GROSSMAN: And do you subscribe to the BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1768
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1 2 3 4 5 6 7 8 . 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 journal Cancer? MR. GLANTZ: MR. GROSSMAN: Cancer? MR. GLANTZ: MR. GROSSMAN: 582 No. Are you familiar with the journal Generally. Have you ever read an article by Wynder, Hirayama and others entitled, "The Comparative Epidemiology of Cancer Between the United States and Japan"? MR. GLANTZ: I have not read that paper. MR. GROSSMAN: Doctor, based upon the numbers of the Surgeon General of the United States and the Ministry of Health and Welfare of Japan, it would show a level of smoking in Japan that is 50 to I00 percent higher than the United States, depending on the year in question. And based further on the statistics in the Wynder Hirayama article, which I will represent to you on consumption per capita of those who smoke, indicating that the average male smoker in the United States, 1986, smoked 23 cigarettes. The average male smoker in Japan smoked 25. In 1980 the average male smoker in the United States smoked 22 cigarettes. The average male smoker in Japan smoked 24.5. Given the fact that far more Japanese men smoke cigarettes; secondly, that those Japanese men who smoke cigarettes smoke, on average, more cigarettes than the average American man who smokes; one would anticipate BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1769
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1 2 3 4 5 6 7 8 9 I0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 583 through your testimony that both the rates of lung cancer and heart disease would be greater in Japan than the United States, is that correct? MR. GLANTZ: No, that's not a reasonable conclusion to draw, and I'd like to address heart disease because that's what I'm here to talk about. There are, as we've discussed, many other confounding variables with heart disease.. In fact, they are more than confounding, they sort of work together. The heart disease rates in Japan are relatively low; in fact much lower than you would expect based on their cigarette consumption. Most people think that's a reflecti6n of dietary differences. They have very low cholesterol diets. One of the things I was unable to present for lack of time in my testimony is evidence that the benzopyrene and other PAHs in cigarette smoke bind selectively to cholesterol and facilitate the atheroscloratic process, so it may well be that certain of these dietary factors are necessary for smoking to have the effects that it does. For example, when Japanese move to America and change their diet, then their heart disease rates change. MR. GROSSMAN: And lung cancer rates go up as well. MR. GLANTZ: That I can't speak to. MR. GROSSMAN: All right. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1770
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 584 Doctor, let me see if I can adjust your testimony slightly. When you said there is a correlation with cholesterol, you're not referring to dietary cholesterol, are you? You're referring to saturated fat intake, isn't that correct? MR. GLANTZ: MR. GROSSMAN: MR. GLANTZ: MR. GROSSMAN: It depends. I'm not quite... I'm sorry. There are a number of foods that are common in the Japanese diet, including shellfish, that are very low in saturated fat, but nonetheless have fairly high dietary cholesterol. And the profound difference between the Japanese diet and the American diet is in saturated fat intake, isn't that correct? MR. GLANTZ: I'm not an expert on dietary differences. The statements that i've made to you are a reflection of my general understanding of the literature and the question which comes up fairly frequently in our editorial board discussions at the Journal of the American College of Cardiology when talking about Japanese studies. And in general, on cardiologic issues. This is one issue that I've heard discussed. I'm not presenting myself as an expert on transnational dietary differences. The fact that the ETS risks persist across countries at relatively consistent BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1771
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1 2 3 4 5 6 7 8 i0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 585 levels, however, suggests to me that these dietary differences are not important in terms of the overall ETS risk. MR. GROSSMAN: You're familiar with the World Health Organization? MR. GLANTZ: Yes. MR. GROSSMAN: Do you rely on their statistics in general? MR. GLANTZ: The work that I do, I don't have much need to rely on their statistics. I presume they're a credible source, but I've never really dug into it. MR. GROSSMAN: Based upon the published literature indicating that the highest level of male smoking in the world is in Japan, one would expect, based upon your testimony, that life expectancy in Japan would be relatively low, wouldn't one? MR. GLANTZ: No. I've really addressed that. There are other factors that play a role in this. I do know that the World Health Organization has said passive smoking causes heart disease at about the magnitude we've estimated. MR. GROSSMAN: In the 1993 World Health Statistics Annual, which is the most recent volume published by the World Health Organization, the average male life expectancy at birth in Japan was 76.4 years. In the United BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1772
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1 2 3 4 5 6 7 8 9 10 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 586 States it-was 71.9 years. In fact, the average male life expectancy in Japan, the country with the highest smoking rate in the world, was the highest life expectancy in the world. MR. GLANTZ: There are many things that contribute to life expectancy. The availability of prenatal care which is a big problem in the United States, is very high in Japan. The nature of their medical service system is quite different than it is here, and you don't have the problems that we have of uninsured and people not getting medical treatment. There's no question that smoking causes heart disease and other diseases, but no one has said, I wouldn't, no one sensible would, would say that smoking is the sole cause of death. There are many, many other contributing factors. The differences in terms of their medical system in Japan are very, very important .contributing factor when you look at life expectancy at birth. JUDGE VITTONE: you going to be? MR. GROSSMAN: JUDGE VITTONE: little bit, we have one more person to follow you. MR. GROSSMAN: I'm going as fast as I can. almost done. Mr. Grossman, how much longer are Probably ten minutes. If you can tighten that up a I'm BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1773
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 587 Even if one looks at life expectancy past birth, say at the age of 45, there is a significant difference between life expectancy in Japan and the United States. In Japan, the World Health Organization numbers indicated that male life expectancy as of age 45 was an additional 33.3 years, and in the United States, 30.8 years. That factors out questions of prenatal care, doesn't it? MR. GLANTZ: That's true, but I wouldn't make the cut point there because most of the big impacts of smoking on heart disease are on like people starting around 40. So it would be more interesting to see cut points where you cut it at like 39. So I don't think that in and of itself is enough to exonerate smoking as a cause of disease in smokers. MR. GROSSMAN: But it does indicate to you that there are many other factors that contribute to heart disease and to life expectancy. testimony. MR. GLANTZ: MR. GROSSMAN: I've said that all through my And the fact that virtually all Japanese men smoked 20 years ago, and that two-thirds do now, whereas fewer than a third of American men smoke now, indicates that other factors are more powerful than smoking in determining both heart disease incidents and life expectancy, isn't that correct? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1774
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5 6 7 8 -9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 588 ~.L~. GLANTZ: Again, I'm not an expert, but it's my understanding that they end up getting things like stomach cancer, which is a very rare disease here. Again, the fact that despite all of these differences, the observe risks of passive smoking and heart disease from the Japanese data is quite consistent with what we observe here in the United States, suggests to me that the issues which you're raising, which are legitimate issues to think about and to discuss, are not a problem in interpreting the data. MR. GROSSMAN: To the extent that the difference in fat intake or cholesterol intake accounts for this startling difference in life expectancy between the United States with its comparatively low smoking rate and Japan with its comparatively high smoking rate, that indicates a need to change the American diet, is that correct? MR. GLANTZ: I'm not an expert on diet. MR. GROSSMAN: You are an expert on cardiova.scular disease, is that correct? MR. GLANTZ: That's true. And the American H~art Association and most cardiologists would recommend that Americans lower their intake of fatty foods. MR. GROSSMAN: Do you believe that an employer with a cafeteria has an obligation to provide low saturated fat diets to its workers? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1775
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 " MR. GLANTZ: now doing that. MR. GROSSMAN: obligation to do so? MR. GLANTZ: 589 Most of the places I'm aware of are Do you believe that they have an I think if they care about their employees it's a good thing to do, and I think there's a demand for it. MR. GROSSMAN: Leaving aside caring for their employees and demand, if American employers provided a diet similar to the Japanese diet and allowed smoking as it's allowed in Japan, since you've testified that there are no ethnic factors that are a strong correlation with heart disease, you would have to assume... MR. GLANTZ: MR. GROSSMAN: MR. GLANTZ: I didn't say that, sir. You testified... I did not. I specifically did not say that. I said independent of other ethnic differences such as hypertension, so let's accurately quote what I said, please. MR. GROSSMAN: You said that independent, you said there is an increased prevalence of hypertension among blacks, but apart from that... MR. GLANTZ: I said that wasn't an accurate representation. That was an example of one of the differences, and those effects lead to... It's the BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1776
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 59O hypertension that has the effect, rather than a statement that the effect of hypertension in black people is different from the comparable level of hypertension in white people, and I do not believe, I'm not sure, but I'm not representing as saying that's the only difference. MR. GROSSMAN: Going back to another part of your testimony... MR. GLANTZ: I was trying to clarify the point. MR. GROSSMAN: Going back to another point, you testified that Japanese-Americans who adopt the American lifestyle die like Americans. MR. GLANTZ: Pardon me? MR. GROSSMAN: Japanese-Americans who adopt the American lifestyle have a health profile that is similar to other Americans. MR. GLANTZ: Ultimately, yes. And it's unlike the health profile of Japanese in Japan. That's my understanding. MR. GROSSMAN: What I'm asking you is, if American employers provided a Japanese diet to their workers and allowed their workers to smoke as they do in Japan, the life expectancy of Americans would increase pursuant to your testimony as you understand it, isn't that correct? MR. GLANTZ: I don't know that I would draw that conclusion. There's a fundamental difference, though. If I BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1777
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 25 591 go to UCSF and all they serve at our cafeteria is greasy, fatty foods, I can bring a bag lunch. I have no control, directly, over the air that I'm breathing at my work site, and I think that's a fundamental difference between the two examples that you're making. MR. GROSSMAN: Doctor, you have no basis to say, isn't it correct, that smoking, even direct smoke, plays as great a role in heart disease as dietary factors? MR. GLANTZ: The American Heart Association and most cardiologists have said that smoking is the leading controllable risk factor for heart disease, so I think that's not an accurate statement. MR. GROSSMAN: Based upon differences between American and Japanese diets and smoking, based on differences in the incidence of heart disease in those two countries~ there is no basis to say that, isn't that correct? MR. GLANTZ: I think that that's not the way scientists make decisions. I can tell you that the consensus in the cardiologic community and the official position of the American Heart Association in reviewing all the evidence, not simply the suppositions that you've advanced to me, is that smoking is a leading controllable risk factor for heart disease in smokers. So, you have constructed a hypothetical case BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1778
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1 2 3 4 5 6 7 8 9 I0 I! 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 592 based largely on material I haven't read, and if you want to draw a hypothetical conclusion from it that's your business, but my understanding of the current views is that smoking is the leading preventible risk factor for heart disease. Period. MR. GROSSMAN: Have you made independent studies to determine the extent to which dietary saturated fat intake or exercise contribute to heart disease? MR. GLANTZ: No. MR. GROSSMAN: MS. SHERMAN: MR. GROSSMAN: All right. Doctor... Mr. Grossman. Please. I have a couple of, just, unrelated questions to what I just said. Very quick questions. Doctor, you spoke earlier about a paper on California restaurants that you published. MR. GLANTZ: California and Colorado. Yes. MR. GROSSMAN: In what journal was that published? Health. MR. GLANTZ: The American Journal of Public MR. GROSSMAN: Was that paper -- that paper is an economic paper, is that correct? MR. GLANTZ: Yes. MR. GROSSMAN: Was it offered to any journal of economics? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1779
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1 2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 20 21 22 23 24 25 593 - MR. GLANTZ: No. We thought the, The American Journal of Public Health has economists who review. They publish articles on health economics, and that's the leading journal in the area. It's the most prestigious journal in the area. MR. GROSSMAN: MR. GLANTZ: In the area of economics? In the area of health, generally, including health economics. MR. GROSSMAN: Was your, to your knowledge, was your article on restaurants in California and Colorado peer- reviewed by a panel of economists? MR. GLANTZ: It was peer-reviewed by a panel of experts selected by the editor, and that is a fine journal and they made it a fine journal by.;. MR. GROSSMAN: That's not the question. MR. GLANTZ: ...selecting appropriate reviewers. They don't tell me who the reviewers are. MR. GROSSMAN: To your knowledge, there were no economists who peer-reviewed your article, is that correct? MS. SHERMAN: Excuse me. I believe he testified that he didn't know who the reviewers were. MR. GROSSMAN: Okay. Whether byname or otherwise, to your knowledge your article was not peer- reviewed by any economist, is that correct? MR. GLANTZ: To my knowledge, it may have been BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1780
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 594 reviewed by economists. It may not have. Knowing the Journal I would expect it was reviewed by economists, because the editor there is a very careful guy. MR. GROSSMAN: Now, you referred earlier to certain typographical errors and other errors in your publication. In order to give us an opportunity to ensure the accuracy of your calculations and otherwise, will you provide to R.J. Reynolds the raw data upon which your publications that you have referred to in this testimony are based? MR. GLANTZ: That's all a matter of public record. MR. GROSSMAN: All of the raw data? MR. GLANTZ: Sure. It's the State Board of Equalization Report... MR. GROSSMAN: I'm not... MR. GLANTZ: Excuse me, sir. Subject to the couple of letters of correction that we've received from Bob Rossi and that has been, which you appear to have already. MR. GROSSMAN: I'm not referring only to the economics article but to the other articles on which you have testified. MR. GLANTZ: Which other articles? MR. GROSS~.~N: Have you referred at any time in your testimony to studies by yourself on incidences of heart BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1781
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1 2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 595 disease by those who are exposed to passive smoke? MR. GLANTZ: The results of those studies are based on the published literature which are available in any library. MR. GROSSMAN: There's no independent work that you did... MR. GLANTZ: We haven't done any independent epidemiological studies. MR. GROSSMAN: Doctor, could you just state for the record the amount by which you believe heart disease deaths would be reduced in the United States by the OSHA regulation as it currently stands? MR. GLANTZ: That I cannot do, because I haven't done that calculation. MR. GROSSMAN: MR. GLANTZ: MR. GROSSMAN: MR. GLANTZ: MR. GROSSMAN: One other thing, Doctor... I believe it would be significant... One other thing, Doctor... ...if I could give you a number. You said earlier in answer to my questioning that you're not a ventilation expert and you cannot comment on the extent to which ventilation in apartment buildings may vitiate risk of others in apartment buildings from exposure to ETS. Do you recall that testimony? MR. GLANTZ: Yes. Because I don't know of, I BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1782
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 596 don't design building ventilation systems for apartment buildings. I've been in apartments where every unit is steam heated. I used to live in one. MR. GROSSMAN: Well, Doctor, do you recall that in response to questions by, I believe, Mr. Dinegar -- you were asked, "Is ventilation sufficient to remove ETS from the work environment?" and you said, "Ventilation is not sufficient"? MR. GLANTZ: That's my understanding based on talking with people who are expert in the area. MR. GROSSMAN: Okay. And so ventilation wouldn't be sufficient in apartment buildings either. Is that correct? MR. GLANTZ: I don't know about how apartment buildings are constructed, sir. MR. GKOSSMAN: Is this a construction problem or is this -- it doesn't depend on whether it's an apartment building or a work building. It just depends on the ventilation system. MR. GLANTZ: And people who are knowledgeable about how such systems are constructed can answer your question. MR. GROSSMAN: So are you suggesting that there are ventilation systems that are currently available in apartment buildings that if applied to work buildings would BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1783
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 597 remove the ETS problem as you see it from work buildings? MR. GLANTZ: was in had steam heat. the rooms. Grossman. Well, the last apartment building I So there was no connection between HEARING OFFICER VITTONE: All right. Mr. Gentlemen. We're not getting anywhere with this. MR. GROSSMAN: All right. Thank you very much, Your Honor. Thank you. By the way, Dr. Glantz, you are not a medical doctor, are you? MR. GLANTZ: No, but I am a professor of medicine at the University of California. MR. GROSSMAN: Have you ever treated a patient with heart disease? MR. GLANTZ: No. MR. GROSSMAN: Thank you very much. HEARING OFFICER VITTONE: Mr. Lowe. Mr. Lowe, would you repeat who you represent and your name, please. MR. LOWE: My name is Michael Lowe. I'm representing the Washington Technical Information Group, Docket No. 103, and I'm also asking questions on behalf of Robert Michaels, Docket No. 106. HEARING OFFICER VITTONE: Mr. Lowe, can you give me an estimate? Repeat what your estimate was? How long you'd be. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1784
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 598 MR. LOWE: An estimate of time? HEARING OFFICER VITTONE: Yes. MR. LOWE: I'm not sure I can give an accurate estimate after watching the proceedings. HEARING OFFICER VITTONE: Just give me an estimate. MR. LOWE: I would think 20 minutes to 30 minutes. HEARING OFFICER VITTONE: All right. It is now 6:30. If you could keep it closer to 20 minutes I think we would all appreciate it. Dr. Glantz, if you would keep your answers limited. It is at the end of the day. This is the last person who has some questions for you. Please try to restrict your answers directly to the question. MR. LOWE: Thank you, Your Honor. Good evening, Dr. Glantz. I understand it's been a long day. But I'm not an attorney. I'm going to try to ask you a few very clear questions about some of the material that I've reviewed either in your written, submitted testimony or in what you spoke about this morning, simply for clarification as I try to understand the process you've gone through in order to better understand the conclusions you've arrived at. Isn't it true, Dr. Glantz, that many of the studies you relied on in your testimony involved active BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1785
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 17 18 19 2O 21 ~.2 23 24 25 599 smoke, even though this hearing is about environmental factors? MR. GLANTZ: A couple of them, for example the platelet study comparing the effects of active and passive smoking, had active smoking in it. The study on free radicals and reperfusion injury could be interpreted either way. But I would say the epistudies are all passive smoking studies, and most of the experimental studies involved models of passive exposure. The only one, as I say, the only one I can think of that had active smoking in it was the platelet study. There are probably a couple of others, but I can't recall what they are, MR. LOWE: For the benefit of my clarification I'd like to step through some that have come to mind for me. The 1985 McMurray study on exercise performance pooled data from smokers and non-smokers, didn't it? MR. GLANTZ: That's true. They compared the effects of passive smoking and smokers and non-smokers. MR. LOWE: And they didn't separate those individuals. MR. GLANTZ: MR. LOWE: correct? Yes, they did. They lumped the data. Is that MR. GLANTZ: I don't believe so. If you want, I BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1786
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 6OO can stop and check, but I don't believe so. MR. LOWE: If they had considered both active and passive or non-smokers, wouldn't this make it difficult to separate the possible effects of ETS exposure from those of mainstream smoke? MR. GLANTZ: You mean if they, if they just pooled them all into one bin without looking at the non- smoker, the passive smoker separately from the active smokers? MR. LOWE: MR. GLANTZ: MR. LOWE: Yes. I'd agree with that. In the 1978 Aranow study on exercise performance, it included active smokers, didn't it? MK. GLANTZ: In, my recollection is they were treated separately. And there have been other studies -- if, I actually think that was just passive, but, again, to answer this I'd have to review the study. MR. LOWE: I have a copy of the Aranow paper with me, and if I can read you a section out of the materials, and I will just read a very brief portion of it. It included ten men. Eight subjects were ex-smokers, two subjects smoked two or four cigarettes daily. So, again, I ask you, does this represent a combination of smokers and non-smokers? MR. GLANTZ: Well, if you actually have those two BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1787
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 601 papers with you I'd prefer to take a brief break and read them and see what I think rather than relying on representations. MR. LOWE: The material I just read you is from The New England Journal of Medicine article in 1978. MR. GLANTZ: No, I have the paper right here. I have the paper here. HEARING OFFICER VITTONE: What's your question, Mr. Lowe? Do you have a question, or... MR. LOWE: I asked Dr. Glantz if in fact this study included subjects that were smokers and non-smokers. Active smokers. HEARING OFFICER VITTONE: All right. MR. GLANTZ: Okay. In the Aranow study two of the subjects had smoked two to four cigarettes daily but did not smoke for at least 16 hours before the study or during the study on each of the three study mornings. That's a very important point, because the effects which are being studied here resolve very quickly. MR. LOWE: Dr. Glantz, I... MR. GLANTZ: Wait. Wait. Sir, you asked a question. I want to give an accurate answer. The ex- smokers, in terms of the material in this study, I don't see that as a problem at all because, again, the kind of effects that they're measuring resolve very quick, within a day or BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1788
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7 8 9 I0 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 602 SO of smoking cessation among active smokers. There have been subsequent studies which are cited in our testimony which I believe were a bit cleaner on this. I don't see this as... I don't see that, I mean, it's a thing that I think you can legitimately criticize the study for but I don't think it's a fatal flaw in the study. MR. LOWE: Can you answer my question as to whether or not it included smokers or non-smokers? MR. GLANTZ: to the study. Period. MR. LOWE: It included people who smoked prior And perhaps subsequent to it. Thank you. Are you aware that there is, or if there have been any government investigations of Dr. Aranow's body of work? MR. GLANTZ: Yes. MR. LOWE: Are you aware of the Horvath Commission's recommendations? MR. GLANTZ: I'm not specifically aware of that. I know that subsequent to the publication of the 1978 paper there were claims of scientific impropriety brought against Dr. Aranow which were substantiated. The only reason, and in fact for that reason, we almost didn't cite this paper in our original, Bill Parmley's and my original 1981 -- pardon me, 1991 -- publication. But the fact that we could find other studies done in other laboratories that produced corroborative results, we included it, and since to my BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1789
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 603 knowledge'there's been no question raised about this... ~.~R. LOWE: But from my reading of your statement, you did include it and you did reference it, which, as a scientist, is a procedure most of us go through in order to gain credibility for our body of work. MR. GLANTZ: Well, we could, we could delete the citation to this study from our work without affecting our conclusions whatsoever because the similar results have been obtained by other independent investigators. MR. LOWE: Additionally, you relied upon several Czechoslovakian studies on rabbits and tobacco smoke, didn't you? MR. GLANTZ: Yes. MR. LOWE: These studies~were a primary basis for your conclusions regarding the effects of ETS on cellular metabolism, isn't that true? MR. GLANTZ: They were not our sole references, but they were important studies. MR. LOWE: If I recall, you cited some of the data from those studies this morning... MR. GLANTZ: MR. LOWE : MR. GLANTZ: MR. LOWE : That's true. ...and showed us a slide. Yes. Are you aware that these studies were designed to examine the effects of active smoking and not BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1790
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1 2 3 4 5 6 7 8 9 10 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 604 ETS? MR. GLANTZ: The exposures that were created were ETS-type exposures, probably more so than active smoking, because what they did was, the rabbits were put in exposure chambers and then cigarette smoke was blown into the exposure chambers. And that, I think, is a better design for studying passive smoking than active smoking, as was pointed out in some of the.cross-examination of OSHA yesterday. There are differences between active and passive smoking. MR. LOWE : MR. GLANTZ: MR. LOWE: Let's focus on this study, Doctor. Okay. I'd like to read you a quote from the study, or from the same authors about this experimental design. The first quote is: "The aim of the present study was to investigate the effect of cigarette smoking on the oxidating processes of heart muscle at the sub-cellular level." And the second quote I'd like to read you: "In our experiment we tried to simulate using inhalation of cigarette smoke in animals the situation in humans after active smoking." Now, I understand I don't have your years of experience in environmental tobacco smoke research, but to me, this sounds like an effort to duplicate an active smoking situation. BAY]hEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1791
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 605 MR. GLANTZ: And I think for the reasons that were brought out in the testimony, or in the cross- examination of OSHAyesterday, that they much more accurately represented a passive smoking environment. The smoke that the rabbits were inhaling was diluted sidestream smoke. It was not hot, which is the smoke that a smoker inhales, and the mixture was different. So I think, they may have set.out to do that, and I think that their data is of relevance in understanding the effects of active smoking. But I also think, because of the nature of the exposure that they gave, it's really equally good and probably better as a study of passive smoking. MR. LOWE: Dr. Glantz, I notice in your Curriculum Vitae that you have taught on experimental design, and I find the comment you made not to be consistent with the standards I would expect in a paper or in a research project that was going to investigate that type of exposure. MR. GLANTZ: MS. SHERMAN: Well, well... Is that a question? MR. LOWE: That is certainly not consistent with what environmental tobacco smoke has been characterized. MS. SHERMAN: Mr. Lowe, is that a question or is that testimony. MR. LOWE: Excuse me? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1792
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1 2 3 4 5 6 7 8 9 i0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 606 MS. SHE~4AN: Were you asking Mr. Glantz a question or were you just giving general testimony? MR. LOWE: Until I was interrupted I was going to say, in view of those issues, do you still claim this was designed for passive smoking? MR. GLANTZ: I think that the data that they produced is more relevant to the issue of passive smoking than active smoking because of the way they constructed their exposures. MR.-LOWE: And you are better suited, in a better position to make that the statement than the authors? MR. GLANTZ: I am in a position to make my own independent scientific judgements based on what I read, and I have from time to time looked at papers, not just on this but in other areas, and drawn conclusions from them based on my best judgement. That's why I'm an associate editor of The Journal of the American College of Cardiology, dealing specifically with these... MR. LOWE: Let's move on to another study that you've talked about. You relied upon a 1989 study by Davis, et. al. for your conclusions about platelets, didn't you? MR. GLANTZ: studies on platelets. different authors. MR. LOWE: That was one of a large number of There were several by several Excuse me. I asked you if you relied BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1793
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 607 upon this-one. I believe it's cited in your paper. MR. GLANTZ: Yes. That was which? Can you tell me, since I don't have the reference list memorized, which one you're referring to? MR. LOWE: In your submitted testimony it's reference number 30. It's cited on page I0. It's the Davis, et. al. paper, "Passive Smoking Affects Endothelial and Platelets." There are only I0 subjects in that study. Isn't that correct? MR. GLANTZ: MR. LOWE: Yes. Isn't it true, Doctor, that the authors of the data study didn't know what significance their data might or might not have for ETS exposure? MR. GLANTZ: I don't understand the point you're making. MR. LOWE: The point I'm making is I believe you used that study to buttress an opinion you've presented, and yet the authors of the study, the investigators that conducted it, made the following statemen6, which I'll read for your benefit. MR. GLANTZ: it appears? MR. LOWE: believe it's page 389. paragraph. Could you tell me where in the paper It's on the last page of the paper. It's in the first complete "The significance of enhanced platelet BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1794
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 608 aggregation formation and an increased concentration of endothelial carcasses, of endothelial cells in blood, after passive smoking is not known." So they simply said they did not understand the relevance of this. Is that correct? MR. GLANTZ: I wish you'd read the next sentence, however. It says, quote... MR. LOWE: I didn't ask you about that, did I? MR. GLANTZ: Well, wait. Wait. Sir, you're taking this very much out of context. They go on to say, "However, both platelet activation and endothelial damage are prominent among the mechanisms thought to be involved in atherosclerosis and arterial thrombosis. Epidemiologic'studies are needed to determine whether repeated episodes of passive exposure to tobacco smoke during a period of years enhance the development of atherosclerosis and its complications in non- smokers." MR. LOWE: Dr. Glantz, I can read it. MR. GLANTZ: You are, you are... I'm sorry. This is very important, because you gave a little speech earlier. HEARING OFFICER VITTONE: Dr. Glantz. MR. LOWE: I'm sorry. He's given a speech accusing me of... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1795
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 609 HEARING OFFICER VITTONE: Dr. Glantz, he's not giving a speech right now. Dr. Glantz, when I ask you to stop I expect that you're going to stop. MR. GLANTZ: Okay. I'm sorry. HEARING OFFICER VITTONE: You don't take it from your students. This is my classroom, Dr. Glantz. MR. GLANTZ: I'm sorry, Your Honor. It's been a long day. HEARING OFFICER VITTONE: That's right. Now. You put it in a context. Do you have a question? MR. LOWE: The second sentence that Dr. Glantz elected to read to us all also has the term "thought" in it. "It's thought." Is this a hypothesis? Or is this a fact? MR. GLANTZ: This paper was written, published in 1989, which was five years ago. They suggested further research was needed, which is not an unusual comment for professors to make, to work this out. I think at the time this paper was written, five or six years ago, the statements they included were quite reasonable. I have interpreted the results in this paper in the context of the data that's available this year. Today, in 1994. And the important thing in this paper is the data, which in Figure 2 shows passive smoking significantly affects platelet aggregation ratio, and in Figure 3, or, pardon me, Figure 4 -- oh, wait -- Figure 3, which shows BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1798
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 15 16 17 18 19 2O 21 22 23 24 25 610 passive smoking significantly affects endothelial carcass cell count. Okay? Despite the small sample size these results were significant at the .002 level. The important thing about this in terms of my... MR. LOWE: Dr. Glantz, you talked about... MR. GLANTZ: ...testimony is the data it includes. Pardon me. HEARING OFFICER VITTONE: Okay. MR. LOWE: You talked about this paper this morning. You represent it as being supportive of part of your testimony, and my point was the authors of it did not make the same representations and I'm not sure that reconstruction of scientists is what we're here for~ But let's move on to another question. This morning in your statement you relied upon a 1986 study of platelets by Burg, Huber, et. al., didn't you Doctor? MR. GLANTZ: Yes. MR. LOWE: The authors of this study were concerned that stress might have produced the results they obtained. Isn't that right? MR. GLANTZ: Again, if you'll point me to where they talk about that I will be happy to look at it. HEARING OFFICER VITTONE: For the record that's number 32 in his testimony. Is that correct? MR. GLANTZ: Yes. Le~ me check and make sure BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1797
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 611 that... testimony. HEARING OFFICER VITTONE: Page 41 of his MR. GLANTZ: Yes. It's number 32. MR. LOWE: Well, if we can turn to page 37, column i, at the bottom of that column on the left hand side, let me again read one of their statements: "Since platelet aggregation has been shown to..." MR. GLANTZ: Excuse me. Let me find it. Let me find it. How far down the column? MR. LOWE: It's in the last paragraph on the left side of page 37. It's starting with the third sentence. "Since platelet aggregation has been shown to vary with emotional stress, this could have lead to a different platelet behavior after acute smoking. We did not measure plasma epinephrine concentrations parallel to platelet function in this study." Isn't it true, Doctor, that the authors of the paper were uncertain about their results from the laboratory, that their results from the laboratory applied to real life? MR. GLANTZ: Pardon me. Could you repeat the question? MR. LOWE: Isn't it true that the authors of this study were uncertain as to whether or not their in vitro BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1798
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 612 study had-any relevance to in life situations? MR. GLANTZ: Okay. I need a minute to read this. MR. LOWE: They have that specific statement... MR. GLANTZ: Sir. Sir. I know. I found the statement but I'd like to read it. The whole statement because, as I noted before, I viewed your statement as an out of context quote. Well, I... You Honor, this is the same problem. He's read one sentence but not the rest of the paragraph. Can I read the rest of the paragraph into the record? HEARING OFFICER VITTONE: Why don't you just explain the... MR. GLANTZ: The... HEARING OFFICER VITTONE: ...question. Wait a minute. Why don't you, what's the question. MR. LOWE: They go on and say, I think since I, they say, "However, if one compares blood pressure and heart rate before and after smoking two cigarettes in smokers and non-smokers, one will find no statistically significant changes in blood pressure and similar marked increases in heart rate in both groups. Despite not being statistically significant, there was an obvious increase in systolic and diastolic blood pressure after smoking two cigarettes in a non-smoking group. This increase could have reached statistical significance if more patients had been studied. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1799
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! 2 3 4 5 6 7 8 9 !0 Ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 613 Nevertheless, it seems unlikely that different agarnergic stimuli" -- the issue the questioner is raising -- "were responsible for the difference in platelet behavior before and after acute smoking." So what the authors have done here -- and this is standard scientific procedure -- is they have raised a possible concern and then they've dealt with it. And I think in both this case and the previous one you simply ignored the second half of the paragraph, where the authors, in both cases, showed that this was a hypothetical concern and then presented affirmative evidence... MR. LOWE: I listened to you this morning. You presented a number of potential mechanisms which you moved into a holistic theory which has very few threads that ties it together from my experience and reading. Did you take the same care to interject the uncertainty and potential issues that would cloud the interpretation of those studies? I didn't hear them, if you did. Wait. That's fine. I'd like to move on. HEARING OFFICER VITTONE: Well, wait a minute. MR. GLANTZ: Do I have to answer? HEARING OFFICER VITTONE: Just a second. Let him answer it now. asked him a question. MR. GLANTZ: You've The first thing is, I was asked to BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1800
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1 2 3~ 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 614 keep my testimony as short as possible. I think if you look at our paper, the circulation paper with Bill Parmley that was subjected to extensive peer review in one of the two leading cardiology journals and published as a reasonable, prudent statement and prudent assessment of the evidence. Since then the American Heart Association has done its own assessment and reached similar conclusions. Now, perhaps you would have written the paper differently than I would have. Everyone has their own approach. But the reviewers of what is one of the two leading journals in cardiology from editors who are very tough and careful people, found our statements supported by the evidence.. And the fact that you can take a couple of out of context quotes from papers written six or eight years ago doesn't change what the evidence says today. MR. LOWE: Let me pursue this, very briefly, because I'd like to move on and it's very late. Is it your testimony that your submitted statement for the record here does not reach the same standards that you would utilize in professional publication of an article? MR. GLANTZ: No. I think in writing my submitted statement, the written statement, I wrote that -- other than the fact that it was for a different audience and hence I tried to simplify things and present it more in lay terms, BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1801
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 615 it was written to the same standards I would write something I would submit to a journal. It would be written differently. MR. LOWE: But the issues that I've raised with you about actual interpretation, perhaps misrepresentation, miscategorization of studies, are from that ~estimony. MR. GLANTZ: I don't agree with your characterization of my work. I think we, ve been very careful to accurately represent this work. I think that you have taken out of context quotes from these papers to build a case that simply isn't true. I wrote my testimony. I stand on it. I think it represents my best judgement of what the evidence says today. MR. LOWE: I heard you state this morning that because of your notoriety or whatever that you are confident that your work will be very carefully revlewedby others. You have a 1980 article cited in your Curriculum Vitae entitled "Biostatistics: How to Detect, Correct and Prevent Errors in the Medical Literature." By the way, published in this circulation also. MR. GLANTZ: Yes. MR. LOWE: I guess that I don't have the same confidence that you have in the accuracy of your submitted testimony. I have one other area that... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1802
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 616 MR. GLANTZ: Wait. Can I respond to that, sir? HEARING OFFICER VITTONE: You know, you're both going to keep arguing back and forth. MR. GLANTZ: Well, he has his right to... HEARING OFFICER VITTONE: You've defended yourself very well. MR. GLANTZ: Thank you. HEARING OFFICER VITTONE: You know, his questions are not testimony. MR. GLANTZ: Okay. HEARING OFFICER VITTONE: His questions are not testimony. The only testimony is what you give. Okay? MR. LOWE: Dr. Glantz, you mentioned earlier that you serve on the California State Scientific Review Panel on Toxic Air Contaminants. Is that correct? MR. GLANTZ: Yes. MR. LOWE: And I believe you mentioned that to tie in your experience in risk assessment. MR. GLANTZ: Yes. MR. LOWE: If I correctly understood that. Are you familiar with the risk assessment procedures that various regulatory bodies go through in trying to determine the potential harm of carcinogens, potential carcinogens or non-carcinogens to the public? MR. GLANTZ: I am familiar with the California BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1803
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 617 risk assessment guidelines, which are the rules under which we operate. MR. LOWE: In those guidelines, do they allow exposures to carcinogens? MR. GLANTZ: Under the -- the way the process works in California, the risk assessment step and the risk management are completely separated. Our committee is charged with reviewing the scientific accuracy of risk assessment documents. The issue you raise is a risk management issue, which is something that we have no direct involvement with. We certify a report under the law as not seriously deficient under the California law... MR. LOWE: And is it your... MR. GLANTZ: Excuse me, sir. You asked the question. Let me answer it. That has been taken, after we have approved it and it has been approved by the California Air Resources Board to the risk management phase, and it is up to the regulators to decide what to do abo~t the risks which we say have been accurately identified by the California Office of Environmental Health Hazard assessment. We have nothing to do with the question of what levels to regulate or whether to even regulate at all. And you're asking... MR. LOWE: Is it your testimony that California BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1804
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1 2 3 4 5 6 7 8 9 I0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 618 does not establish permissible exposures to carcinogens in the risk assessment process? MR. GLANTZ: That's right. The risk assessment process has nothing to do with that as it's implemented under AB-1807 in California. At least our piece of it. It may happen later in the process, but I frankly have no idea what they do. And I don't care, frankly. That's not our job to make... MR. LOWE: And is that also the cases for other regulatory bodies that make these types of risk assessment calculations, including some that you've noted that you've worked with, including those of the EPA, OTA and other bodies? MR. GLANTZ: I have worked with the EPA and the OTA. I've worked with the OTA as a reviewer for one of their documents. To my knowledge, OTA is not a risk management organization. The work I've done with the EPA had to do with preparing some materials and reviewing some materials for them and, again, had nothing to do with risk management. So I have no knowledge of exactly how those agencies deal with risk management. MR. LOWE: If I were to represent to you that all of the agencies we've just discussed, including California, EPA, OTA, and others, had at one time or another represented that the risk of various compounds -- carcinogens and non- BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1805
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1 2 3 4 5 6 7 8 9 I0 iI 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 619 carcinogens -- should be addressed on a dosed response basis. Do those agencies recognize that various toxins may be more toxic at higher levels than at lower levels? MR. GLANTZ: In terms of carcinogenicity, that's the general assumption that is made. In terms of heart disease, which to my knowledge none of them have dealt with in the area of passive smoking, I believe the evidence supports a very steep dose response curve at low doses and a qualitative difference in the response between smokers and non-smokers. And I believe that the risk management approaches that would be appropriate with ETS and heart disease may be different than when you're dealing with carcinogens. These organizations, to my knowledge, have not, up until OSHAbecame involved in this issue, really looked at the question of heart disease as having an environmental component. MR. LOWE: If the dose response curve is very steep -- and you'll have to help me here, I'm not a biostatistician -- how steep is steep before there is no dose response? Does that mean that at one tested concentration you saw a response and at a higher concentration you saw the same response -- exactly the same -- so that as you graphed that you had a vertical line? MR. GLANTZ: Well, in terms of the bleeding times BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1808
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1 2 3 4 5 6 7 8 9 !0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 62O that we observed in, in fact in all of our studies -- I know we have shown you one -- that's what happened. We found very similar effects at all doses that we. looked at. If you look at the Burg, Huber platelet studies, they were showing that you got essentially the same effect if actively smoking two cigarettes as passively smoking in non-smokers, in terms of platelet function, and that suggests to me that it's a very, very steep curve. The other thing that's important, which I mentioned in my testimony, is that ETS is a gratuitous pollutant. It's not necessary as part of the manufacturing process and to my knowledge... MR. LOWE: Did I ask you anything about that? MR. GLANTZ: Well, but, you see you're asking response. steep. MR. LOWE: I was trying to ask you about dose MR. GLANTZ: Okay. To my knowledge, it's very HEARING OFFICER VITTONE: All right. Thank you. MR. LOWE: For non-carcinogens, do those same agencies acknowledge a dose response? MR. GLANTZ: The only non-carcinogen which we have dealt with on the scientific review panel in terms of non-cancer in-points is lead, which is currently under BAYLEY REPORTING, INC. (202} 234-7787 (800) 368-8993 Tl1011-1807
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 621 review, and I don't think it would be appropriate for me to discuss that at this point because this is currently being hotly debated. How to handle that. MR. LOWE: Hasn't the government established safe exposure levels of lead in the past? And we recognize that those have changed over time and that there are allowable levels in drinking water? MR. GLANTZ: You may well be correct. I'm not representing myself as an expert in different strategies of risk management. I think my service on the California State Scientific Review Panel is of relevance in terms of my knowledge of risk assessment techniques which, the way we handle it in California, is completely divorced by law from the way -- from the questions you're asking. So I can respond to these things as an interested layman, but I'm not expert on the risk management procedures used by any of the agencies that you're dealing with. MR. LOWE: If I understood what you've said, you've also stated that you're not that familiar with risk assessments, either. MR. GLANTZ: No. I did not say that, sir. I am quite familiar with it. I've been on this panel for many years and been reappointed to it two or three times because of my recognized expertise in the area. ~K%. LOWE: What is the role of nicotine in any of BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1808
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 622 the effects we've talked about today that you're concerned about? MR. GLANTZ: Nicotine is an important element in the action of second-hand smoke on the heart. The issue having to do with free radical scavenging and reperfusion injury has been clearly proven to be related to nicotine. MR. LOWE: Excuse me. Let me go through these one at a time. With free radical scavenging, as I understand in your testimony, this could be a contributor answer it. MR. GLANTZ: MR. LOWE: MR. GLANTZ: Well, the free radical... ...a separate radical... Now, you asked the question, let me The data that shows that nicotine per se is very important in terms of the reperfusion injury due to free radicals is from experimental data that shows that when you give nicotine you make the effect worse, and when you give a free radical scavenger, an exogenous free radical scavenger, you can block the nicotine effect. That is about the most direct evidence that you can have. There are other... Nicotine also -- oh, and another thing which is very important in that study that I didn't mention is that's at doses of nicotine which are so low that they don't provoke any hemodynamic change. Higher BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1809
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 623 doses of nicotine will increase heart rate and blood pressure and increase cardiac contractility. Now, the platelet effects, I believe, are probably not due to nicotine. There are other constituents in the smoke. MR. LOWE: Even though nicotine may affect cardiac contractility, blood pressure, are those pathological events in and of themselves? MR. GLANTZ: If you have an individual whose cardiovascular -- whose heart and cardiac circulation -- is compromised, then the effects -- these effects -- could be precipitating events which push them over the edge. MR. LOWE: But I didn't hear you limit the risk of that to people with advanced coronary heart disease, which I assume you're referring to. MR. GLANTZ: No, but you asked a very specific question, and that is: Could the exposure to nicotine precipitate a specific pathological event? I think that the effects that we're dealing with, some of the effects -- and this is one thing that makes heart disease very different from cancer -- some of the effects of smoking and passive smoking on the heart are due to the immediate poisoning from the nicotine, carbon monoxide and many other compounds in the smoke. Other of the effects are cumulative and long-term damage and for BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1810
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1 2 3 4 5 6 7 8 9 I0 Ii 12 13 14 IS 16 17 18 19 20 21 22 23 24 25 624 example, to the extent that nicotine affects platelet activity and to the extent that activated platelets participate in damage to... MR. LOWE: I didn't ask about those. MR. GLANTZ: ...you've got those obstructed .... MR. LOWE: I asked you about blood pressure... MR. GLANTZ: Then the nicotine is contributory. MR. LOWE: I asked you about the blood pressure. MR. GLANTZ: And my answer to the blood pressure question specifically, and limiting to blood pressure, is those changes could precipitate an event. Also chronic elevations in blood pressure are a bad thing for the heart too. MR. LOWE: Are you familiar with any natural substance in our body that affects blood pressure? MR. GLANTZ: Oh, there are many. MR. LOWE: What would be the most likely one that you could mention? What's the most common one that's implicated in blood pressure elevation, pathologically? MR. GLANTZ: Pathologically, it's probably the reniangiotensin system. MR. LOWE: And is that implicated in the process you're talking about? MR. GLANTZ: I haven't said that it is. MR. LOWE: What about norepinephrine... BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1811
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 17 18 19 2O 21 22 23 24 25 625 MR. GLANTZ: It aggravates the chronic hypertension. MR. LOWE: What about norepinephrine and epinephrine? Do they modify cardiac contractility, heart rate... MR. GLANTZ: Yes. MR. LOWE: Depolarization in the heart? MR. GLANTZ: Yes. MR. LOWE: And blood pressure. MR. GLANTZ: Yes. MR. LOWE: Thank you. That's all, Your Honor. HEARING OFFICER VITTONE: Thank you, Mr. Lowe. Ms. Sherman, do you have anything you want to have clarified? Any redirect of the witness? MS. SHERMAN: I was hoping to have the evening to think about it and do it first thing tomorrow morning. HEARING OFFICER VITTONE: We have three witnesses tomorrow. I thought that the reason we stayed here so late was to make sure that he could leave. MS. SHERMAN: Okay. Well, if we can have a five minute break I'd be happy to ask the questions now. HEARING OFFICER VITTONE: How long were you going to take? MS. SHERMAN: Five or ten minutes. HEARING OFFICER VITTONE: Fine. You get a five BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1812
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1 2 3 4 5 6 7 8 9 i0 II 12 13 14 15 16 17 18 19 20 21 22 23 24 25 626 minute break. (Whereupon, a brief recess was taken.) HEARING OFFICER VITTONE: Ms. Sherman. MS. SHER~N: Yes. I do have some questions for Dr. Glantz. I will try to be brief. Do you think that the Bellflower data that Mr. Rupp asked you about represents a fatal flaw in your restaurant study? MR. GLANTZ: No, I don't. He was really focusing on a couple of quarters worth of data and I think it's important to look at our -- the thing I testified to as our publication in The American Journal of Public Health, which included many more cities and many more quarters of data, and with the epidemiology studies, it's important to look at all the data taken together. That increases the power of the study to detect a real effect and it also reduces your chances of a false positive conclusion. MS. SHERMAN: So, then, just so I can understand better for the record, most of Mr. Rupp's questions dealt with a preliminary study and your testimony dealt with a later study? MR. GLANTZ: That's right. The initial four city study which we almost exclusively dealt with was our first attempt to look at this data, which we did because there was a lot of interest in it. But we recognized that there was a BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T11011-1813
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2 3 4 5 6 7 8 9 i0 ll 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 627 need for more data so that's why we continued to collect information and ultimately submitted it for publication in The American Journal of Public Health. Which it covers the initial study he talked about, had four cities with a few quarters of experience with the ordinances. The paper I testified to today had 15 cities with many, many more quarters of data. MS. SHERMAN: Speaking of restaurants, I believe, perhaps in your written testimony, there was some reference to an epidemiological study involving elevated risks of waitresses and waiters. Do you believe this to be a reasonably decent study? MR. GLANTZ: Yes. The study referred to is a paper by Michael Siegel called "Involuntary Smoking in the Restaurant Workplace: A Review of Employee Exposure and Health Effects" which shows that restaurant workers have much higher exposures to environmental tobacco smoke than workers in general and a commensurate increase in their levels of lung cancer. work. MS. SHERMAN: I think this is a very good piece of I have not read the study myself. However, I have heard various comments and one of the questions I heard asked was, were the people he studied smokers themselves? Do you happen to know the answer to that? BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1814
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1 2 3 4 5 6 7 8 9 i0 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 628 MR. GLANTZ: Yes. Some of the people who were looked at in that study were smokers but he was showing elevations in risk even above what you would expect based on their smoking rates. MS. SHERMAN: MR. GLANTZ: And he was... He didn't... Siegel did not -- his paper was a review of the literature and so he was comparing data, looking and analyzing data other people had collected. So he didn't directly measure whether people smoked or not, but what he showed was that the lung cancer rates among, say, waitresses as a group were higher than what you would expect based on their smoking rates. So there was an additional effect on top of any effects that smoking might have. But here we're looking at both the non-smoking waitresses and the smoking waitresses thrown into one pot and the overall lung cancer rate was higher than you would expect based on their rate of smoking alone -- of active smoking.alone. And he drew similar conclusions for other categories of food service workers, and I think it's a reasonable analysis. MS. SHERMAN: among the non-smokers? MR. GLANTZ: constructed. Did he do a separate analysis just No. That wasn't the way this was BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1815
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 629 MS. SHE~4AN: Would the study have been large enough to have allowed that? MR. GLANTZ: Again, he was comparing -- looking at rates in different groups, so that's really not a relevant question, I don't think. MS. SHERMAN: You testified before about the Burg, Huber and Davis paper, at some length I believe, or you answered questions on it. Were the cautionary statements made by Berg, Huber & Davis appropriate at the time they wrote the paper? MR. GLANTZ: Yes. In both cases they raised potential concerns about their data and then addressed those concerns as b~st as they could. In the case of Davis, he suggests that we needed to do more research. But even at the time he said that this is certainly strongly suggestive of an effect. MS. SHERMAN: Do you understand these cautionary statements to mean that one cannot interpret the study in light of subsequent studies published after the mid-80's? MR. GLANTZ: Absolutely not. I think that the statements that they made at the time were appropriate and scientifically prudent. What we have done is use the data that they published, the conclusions that they drew, in light of the information that's been developed in the eight or ten years since this work was done and looked at this in BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1816
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1 2 3 4 5 6 7 8 '9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 630 the context of all of the data. MS. SHERMAN: Is this accepted scientific practice, to look at a study in light of later studies and perhaps come to different conclusions than the original authors? MR. GLANTZ: Well, first of all, we didn't come to different conclusions than the original authors. The original authors both concluded passive smoking had an important effect on platelet activity and in one case endothelial cell carcasses, which means damage to the lining of the arteries. So there's no difference in our interpretation of their data. The thing -- the whole discussion dealt with how to interpret cautionary statements about the interpretation of those results at the end, and basically what both authors were saying is that we need more information to draw firm conclusions, and since then a great deal more information has been developed. But it's very important to stress that we didn't interpret their data any differently than they did in terms of what they reported. The question is, what's the larger context in which you interpret those findings. MS. SHERMAN: And are you aware of other reputable scientists besides yourself who have in the past interpreted studies, perhaps not Berg, Huber, but other studies, in light of subsequent evidence? BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1817
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 631 MR. GLANTZ: Yes. Every scientist does that. That's how we advance our knowledge. MS. SHERMAN: I believe youtestified concerning the effects of environmental tobacco smoke and heart disease by citing a study involving rabbits. MR. GLANTZ: Yes. MS. SHERMAN: I think you even showed a slide about that. Could the results that you found be attributed to increasing the catecholamine levels? MR. GLANTZ: No, they couldn't. We showed that when you reduced the catecholamine levels, the sort of nervous things that were talked about at the end in the previous cross-examination, that that did reduce the development of fat deposits in the arteries. But when we exposed the rabbits to environmental tobacco smoke you still got an increased effect, whether or not the catecholamines were present. And what that says to us is that the effects of ETS on the arteries is not a catecholamine effect. It's a direct effect of the ETS rather than being mediated through changes in the nervous system. MS. SHERMAN: One last question. You had an interesting slide on reperfusion injury. Could you clarify the effects of low doses of nicotine on the reperfusion injuries that you discussed? MR. GLANTZ: Yes. What happens when you stop the BAYLEYREPORTING, INC. (202) 234-7787 (800) 368-8993 Tl1011-1818
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1 2 3 4 5 6 7 8 9 i0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 632 flow of blood to a part of the heart muscle and then start it again the muscle doesn't contract as well. It doesn't shorten as much. And what the study in question showed is that you exposed, if you give -- in this case dogs -- a low dose of nicotine, so low a dose that it didn't provoke any of the kind of changes in heart rate or blood pressure that we were talking about in other parts of the discussion, that that made the reperfusion injury twice as bad. And then if you gave a drug which was a free radical scavenger, the effect of the nicotine was eliminated. And so what that means is that the nicotine itself was what was aggravating the reperfusion injury. And it was done at a very, very low dose of nicotine, too. MS. SHERMAN: It was one or two cigarettes worth? MR. GLANTZ: It was the nicotine equivalent of one cigarette administered over a brief -- I think about ten minutes. Administered intravenously. But it was not a big enough -- see, higher doses of nicotine provoke changes in heart rate and blood pressure and how hard the heart has to work. And the importance of this study is that it showed that nicotine levels way below those which provoke changes in blood pressure and heart rate still have significant adverse effects on the heart under these conditions. MS. SHERMAN: All right. Thank you, Dr. Glantz. That's all I have. BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 TI1011-1819
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 2O 21 22 23 24 25 MR. GLANTZ : Thank you. HEARING OFFICER VITTONE: 633 Thank you, Ms. Sherman. Thank you, Dr. Glantz. That concludes your testimony. MR. GLANTZ: Thank you. HEARING OFFICER VITTONE: We will recess and resume tomorrow morning at 9:30 at the Department of Interior Auditorium at 1849 C Street NW, and we will be there tomorrow and on Friday. Thank you very much. MR. TYSON: Your Honor, may I ask the sequence of witnesses? MS. SHERMAN: When the schedule was developed, I believe it was just meant to locate a witness on a day. Let me try to find... The schedule that I have shows that Mr. Levine will be first, Mr. Steenburg second and Mr. Sammet third. We will at least try to start with Mr. Levine. I'm not sure about the travel plans of Mr. Steenburg and so will have to take it as it comes. HEARING OFFICER VITTONE: Thank you. (Whereupon, at 7:30 p.m. the hearing was recessed, to reconvene at 9:30 a.m. on Thursday, September 22, 1994.) BAILEY REPORTING, INC. (202) 234-7787 (800) 368-8993 Ti1011-1820
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1 2 3 4 5 6 7 8 9 I0 ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 REPORTER'S CERTIFICATE 634 TITLE: DATE: LOCATION: Indoor Air Quality Proposed Rule Hearings September 21, 1994 Washington, D.C. This is to certify that the attached proceedings were held according to the record and that this is the original, complete, true and accurate transcript which has been compared to the reporting or recording accomplished at the hearing. BAYLEY REPORTING, INC. September 21, 1994 BAYLEY REPORTING, INC. (202) 234-7787 (800) 368-8993 T!1011-1821

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