Tobacco Documents Online

I I I 71 SENATOR LIEBERMAN: So you -- am I hearing you correctly that you'd say that the method used was not the appropriate method to use? Or put it this way, that one -- it may be appropriate but one should not draw too firm a conclusion from it because there are -- if I'm hearing you correctly, there are other substances... DR. BLOTT: Right. There are many others. I I I I I I I I I I I I I I SENATOR LIEBERMAN: ...in smoke that may not have been measured by him. DR. BLOTT: Right. And we really don't know what is the best measure of exposure. It could be cotinine. It could be one of the carcinogens in cigarette smoke. For example, there's a carcinogen called 4 aminobiphenyl. If you look at hemoglobin addicts to this particular carcinogen in smokers compared to passively exposed nonsmokers, the ratio is only seven to one. That is, smokers only have seven times more of this compound in their body than environmentally exposed nonsmokers. So, if it turns out that that was the relevant measure, then nonsmokers are getting the equivalent of one-seventh. And if you figure that 20-pack-a-day is an average -- or 20 cigarettes a day for one-pack-a-day smoker is average, one-seventh of that is about three cigarettes a day. Not a year, three cigarettes a day. SENATOR LIEBERMAN: Okay. So that's a dramatic difference. Dr. Coggins was suggesting maximum impact on a nonsmoker breathing in smoke would be one to four cigarettes a year. You're saying under that, under the method you've just described, it could be as high as the effect of three cigarettes per day. DR. BLOTT: Right. We really don't know for sure what it is. But there is this range. SENATOR LIEBERMAN: Right. DR. BLOTT: And what was cited earlier was the extreme low end of that range. SENATOR LIEBERMAN: Yeah. So, is there any basis for concluding that the EPA report is on the other extreme, or is it more balanced? DR. BLOTT: Well, the EPA recognized these problems in dealing with biomarkers, and instead used the directly available epidemiological evidence. It's been mentioned several times today that there have been numerous studies, over 30 different studies of lung cancer and many more of childhood diseases, that actually I

I 72 measured risk associated with household exposure to environmental tobacco smoke. So we have some actual, observable data. If you summarize that data, it turns out that there is a small -- granted that it's small -- but a measurable increase in risk of lung cancer among people who've lived with smokers, even though they don't smoke themselves. SENATOR LIEBERMAN: Okay. Thanks for that answer. DR. Gravelle, to an element of the uncertainty of estimates. In your testimony you discussed the uncertainty of EPA's methodology. And to check the numbers, I think you indicated that you've used the physical extrapolation method. I wonder why you used that method to check EPA's analysis, given the uncertainties associated with the method. Which is to say, as Dr. Blott has just indicated, it does not assess all of the exposures that are parts of secondhand smoke. DR. GRAVELLE: Well, we used it because, while there, are uncertainties in that method, there are also a lot of uncertainties in the statistical studies. We used cotinine itself because that's what the EPA used and that's what all of the literature that the EPA reviewed, with one exception, used, is the cotinine level. Now, there was one study that used the respirate-suspended particulate that Dr. Coggins talked about, which produced very small results. There's uncertainty -- I mean I would -- this is not really my field, but it's clear that there are uncertainties about this method. The EPA used cotinine for a whole variety of corrections to their data. They used it for, they used it for making a correction for classification error. They used it for extrapolating from the 500 direct deaths that you could estimate from the statistical evidence to the other 1000 female never-smoker. In other words, most of the numbers in their study are from this kind of method. Now, it's within the group of passive, rather than from active to passive, but that's certainly an approach that they used and relied on. And the cotinine measures are relied on all through the (unintelligible] study to deal with a whole series of problems. We're not saying that this is a perfect study, but we're just saying we see some serious problems with the statistical studies. And when you see serious problems, you want to go back and try to check it against alternatives. I I I I I I I I I I I I I I I I I I

I I 73 I I SENATOR LIEBERMAN: My time's up but let me just ask this, if I may borrow from Senator Faircloth. Maybe you can give me a one- word answer or something close to it. Accepting that there are uncertainties here in this method, why did you reach the conclusion that they overestimated? Isn't it possible that they could have underestimated the consequences of secondhand smoke? I DR GRAVELLE W ll th ti l i . : e , e par cu ar spec fication problems I I I I I with the epi studies that were identified were -- that were clearly identified with the direction were certainly in the direction that would overstate the study. There are two of those and they're discussed in the EPA study. They're all in the literature: the misclassification issue and the confounding factors. ~ So, those would have both gone in the direction of reducing the estimate, had -- in theory, at least had you been able to correct for them. SENATOR LIEBERMAN: Okay. My time's up. Senator Faircloth. SENATOR FAIRCLOTH: Thank you, Mr. Chairman. Senator Lieberman's going to bring this to a conclusion pretty fast. So if you will be extremely brief in your answers. I DR. GRAVELLE: I'll try. SENATOR FAIRCLOTH: And also Dr. Blott. I My first question is, and very brief, what is the mission of the Congressional Research Service? What's it supposed to do? I DR. GRAVELLE: our mission nonpartisan information to Congress. is to provide objective, I SENATOR FAIRCLOTH: Okay. So it is -- when you all say something, it's right. You have no reason for it to be otherwise. I DR. GRAVELLE: Absolutely. [Laughter] SENATOR FAIRCLOTH: Okay. I DR. GRAVELLE: No. research. I have no other motive than to do SENATOR FAIRCLOTH: I move to Dr. Blott. And if you would be I I very brief. I

I 74 I've been advised that the National Cancer Institute funded the Brownson and the Alejano (?) studies. [Unintelligible] correct pronunciation. The largest U.S. studies every conducted on lung cancer in nonsmokers. My understanding is that the reason that the Science Advisory Board of EPA did not insist on the inclusion of those studies in the EPA risk assessment is that the studies weren't completed in time for the EPA analysis. Were they completed in time? time. DR. BLOTT: I think that's right. They were not ready in SENATOR FAIRCLOTH: They were not ready. You think, you're not sure. DR. BLOTT: That's my impression, they were not ready. SENATOR FAIRCLOTH: That's what EPA said. DR. BLOTT: I think that's the case. SENATOR FAIRCLOTH: However, under its guideline, EPA is required to address the existence of confounders, isn't it? DR. BLOTT: Uh-huh. SENATOR FAIRCLOTH: Isn't this sound scientific practice? DR. BLOTT: The consideration for confounding effects? Yes. SENATOR FAIRCLOTH: If EPA were conducting its own analysis today, wouldn't you recommend that those studies be included? DR. BLOTT: Sure. You know, studies are continually being done. And as time passes, we get new information all the time. SENATOR FAIRCLOTH: Since OSHA is in the process of conducting its own risk assessment, you would advise them to include these studies, too. DR. BLOTT: Uh-huh. SENATOR FAIRCLOTH: All right. Do you have a -- children? DR. BLOTT: Yes. if I may ask a question, do you have SENATOR FAIRCLOTH: Do you take them to the beach? I I I I I I I I I I I I I I I I

I I I I I I I I I I I I I I I I I 75 DR. BLOTT: Sometimes I do. Yes. SENATOR FAIRCLOTH: Well, aren't you exposing them to a high risk of cancer later on in life? Many studies have indicated that children exposed to sun early are at high risk for cancer. Isn't that a pretty dangerous thing you're doing with your children? DR. BLOTT: Sunlight exposure is a risk factor for skin cancer, for the regular type and for melanoma, which can be fatal. When we go to the beach we attempt to take precautionary measures, including sunscreens and avoid burning. SENATOR FAIRCLOTH: Oh, I understand that. But why not just not go? We're closing down smoking because it's a risk of cancer.' How about french fries at fast-foods? Do you ever let children eat those? DR. BLOTT: Sometimes my kids do. Yes. SENATOR FAIRCLOTH: Well, what do you to do that? You give them a stomach lining or something? DR. BLOTT: I think the issue is whether or not we have enough evidence before us right now to declare that exposure to environmental tobacco smoke is harmful. And I think we do. SENATOR FAIRCLOTH: I have one more question. You're married. DR. BLOTT: Yes. SENATOR FAIRCLOTH: Does your wife smoke? DR. BLOTT: No, sir. SENATOR FAIRCLOTH: If she did, would you divorce her? DR. BLOTT: [Laughter] SENATOR LAUTENBERG: Depends on the alimony. SENATOR LIEBERMAN: You could plead the Fifth here. DR. GRAVELLE: [Laughter] DR. BLOTT: I think it's unlikely that she would ever smoke cigarettes. SENATOR FAIRCLOTH: That wasn't the question. If she did, would you divorce her? I

I 76 DR. BLOTT: I don't know what would happen in that situation. It's unlikely I would divorce her. SENATOR FAIRCLOTH: The point I am making is clear. SENATOR LAUTENBERG: Indeed. SENATOR FAIRCLOTH: We have gone to fairies -- angels dancing on needle points into this smoking. We are completely ignoring every other risk factor for cancer. The beach, you take your children. As Dr. Taylor said earlier, his children could not go to a restaurant, he didn't want them to go or whatever, because there was smoke in it. His grandchildren. I assume they go to the beach. Most do. So we're taking one issue and making it the whipping boy, and we are blithely going like a blinded and deafened horse to the battle on every other cancer issue. We talk about -- you talk about putting a 60-cent sun lotion on your children and take 'em to the beach, and it doesn't concern you. Yet -- I'll not say you. People of your mind-set go into a spasm if you go into a restaurant and there's smoking in one dark corner of it. I just -- I think we ought to be fair. I thank you. SENATOR LIEBERMAN: Thank you, Senator Faircloth. We're trying hard to assess different forms of threat to the American people. And I do want to say, Dr. Blott, that I'm reassured that your marriage has survived the threats that may have been placed on it. DR. BLOTT: Thank you. SENATOR LIEBERMAN: Senator Lautenberg. SENATOR LAUTENBERG: Thank you very much. Do you drag your kids to the beach, just pull them along by a hand, over the curbs and all that, to get them down to the beach? DR. BLOTT: No, sir. SENATOR LAUTENBERG: Or do they voluntarily go? DR. BLOTT: It's voluntary. I I I I I I I I I I I I I I I Ca I ~ - c. ,n ~ c.~ I

I I I I I I I I I I I I I I I I 77 SENATOR LAUTENBERG: Yeah. So what happens when they're in a room with smokers? Do they get a chance to voluntarily block it out, or do they have to take what's in there? DR. BLOTT: They might not get a voluntary chance. You're right. SENATOR LAUTENBERG: My kids go to the beach. I try to convince them to cover up. I try to convince them not to take the unnecessary risk, at least to make their own independent decisions to what to do. Dr. Gravelle, one of the things that concerns me. You suggested -- admitted, I might say, because my background's in economics, too, that you're both economists. Is that true, Dr. Zimmerman? [Affirmative indication] SENATOR LAUTENBERG: Okay. So here we are, the three of us, in an unscientific science. Although my education is not as extensive as yours. DR. GRAVELLE: No, no. SENATOR LAUTENBERG: Have you ever -- you have medical science people in CRS, do you not? DR. GRAVELLE: That's correct. SENATOR LAUTENBERG: Why didn't they do this report, or their response to the report? DR. GRAVELLE: Well, the passive-smoking issue in our cigarette tax paper was a fairly minor subset of a lot of different things we did. And we consulted very closely with them. The report was read and approved. And I spent a lot of time with the Science Policy Division doing this report. SENATOR LAUTENBERG: Did they -- they weren't asked to do the -- to write the analysis of the EPA study? You did... DR. GRAVELLE: Our paper was not about -- I'm sorry. This is a small part of this paper on cigarette taxes that had to do with passive smoking. SENATOR LAUTENBERG: So it was focused primarily on the tax issue and the assumptions. I

I 78 Were the assumptions about the risk essential to the determination of what the revenues might flow, what revenues might flow from the taxes? DR. GRAVELLE: Well, we looked at, you know, revenue yield. We looked at the price elasticities. You,look at the path of revenue over time. We did all those things. But the part of the paper that this was related to was really measuring spillover cost and trying to compare those to existing cigarette taxes. And one of the spillovers, obviously, was -- that we had to look at was the passive-smoking issue. SENATOR LAUTENBERG: So, was the assertion that the methodology might not have been precise, in your view, did you have to make the case by getting to the health effects? Because if you were interested in the financial yield on this, then I'm trying to understand why it is that we got into the question of whether or not the health-effects analysis was... DR. GRAVELLE: Well, as you know, when you -- one of the efficiency issues that you would look at in doing an economic analysis is whether smokers are having the right sort of price signals when they buy cigarettes. And part of those price signals are effects that they have on other people that are not price. And one of those effects -- there are lots of different kinds of effects we looked at. Health care costs, direct health care costs of smokers was one we spent a lot of time on. And one aspect of that that we felt was crucial to that analysis was the passive- smoking ef f ect . SENATOR LAUTENBERG: Okay. So you're saying the net yield, because the savings might not have been there as a result of non- ill-health effects. DR. GRAVELLE: That's right. There are two basic kinds of spillover effects. One is the potential medical effects, basically because we charge the same insurance premiums for smokers and -- we don't differentiate by smoking status. That's one effect. And you have to look at that over a whole lifetime. And the second effect would be the passive smoke -- well, actually we talked about other things. We talked about annoyance and all the things we could think of and measured all the things we could try to measure. And there's a whole series of issues we looked at. SENATOR LAUTENBERG: I'm going to commission a study by CRS on annoyance and see how much that costs the government every... DR. GRAVELLE: That one's hard to measure. SENATOR LAUTENBERG: But how about us, one to the other, here? I I I I I I I I I I I I I I I I I

I I I I I I I I I I I I I I I I I I 79 Anyway, what -- was your CRS report peer-reviewed by outside experts in any way? DR. GRAVELLE: In general, the process through which we go in receiving a request, answering a request, reviewing a request is confidential, at the wish of Congress. I will say that we have internal review in our subject area. We have internal review in cross-disciplinary subject areas, other subject areas that are relevant to our studies. We have internal review. We have external review when it's appropriate. We do -- as you know, literally, we handle thousands and thousands of requests every year, and so there's not a consistent review process. I'd say that the'study -- there was a good look at this study from lots of sources, congressional sources, non- congressional sources, or discussions that we carried on with people that was -- it was, in my view, a very carefully examined study. SENATOR LAUTENBERG: Yeah. It didn't have the same type, for the reasons stated, peer review as the EPA study. I mean the EPA... DR. GRAVELLE: Well, we have a different -- we have no regulatory authority. We have, you know, no influence on the regulatory authority. And, of course, if there were to be criticisms after a paper is released that we thought were valid, we certainly change our papers. And we've done that before. Every once in a while, answering all the questions, you make a mistake. There's no problem with that. SENATOR LAUTENBERG: Have you had any criticism related to your observations? DR. GRAVELLE: No, sir. SENATOR LAUTENBERG: The EPA Administrator stated, and several other people, that she believes that ETS can cause as much as -- as many as 3000 lung-cancer deaths a year. You seem to suggest that there are only -- you suggest that there are only -- there might only be 600 deaths per year related to ETS. You therefore -- in your comments you say, "Our evaluation was that the statistical evidence does not appear to support a conclusion that there are substantial health effects of passive smoking." When -- how much more than 600 deaths does it have to be to get to be to be substantial? I

I 80 DR. GRAVELLE: Well, I guess substantial is sort of in the eyes of the beholder. The risk -- let's even take the EPA numbers. Let's take the 3000 deaths. I would characterize those as small risk.. Perhaps you wouldn't. They are in the same general magnitude, let's say, of the risk of driving a small car instead of a large car, which is safer than a small car. The lifetime risk is in the neighborhood of one-tenth to two-tenths of a percent. And since the chance of dying is 100 percent. So, compared to many other risks -- you face risks all the time. And it's one of the things of economics that I think is very valuable in looking at this subject is people do face risks of all sorts of different types all the time. We live risky lives. And the question is, I think, what risks do you want to correct at what costs? Is it worth it? Is it large enough? And... SENATOR LAUTENBERG: If it's my kid it's large enough. I can tell you that. Also, I make sure that my children -- they're adults now, but my grandchild -- that they use seatbelts. The risk of dying in a car accident, compared to the number of miles driven each day, is pretty darn small. DR. GRAVELLE: That's right. SENATOR LAUTENBERG: But why take the extra risk if you don't have to? Why should the 600 who might die -- and if you're wrong, perhaps it is 3000 -- why should we take that risk if we don't have to? Aren't we obliged to protect the public health? Six hundred -- and it's alleged, and I haven't heard you challenge that, that much of this risk is to small children and that the 150,000 incidents a year of some asthmatic response to smoke -- are those insubstantial risks, in your mind, Dr. Gravelle? DR. GRAVELLE: We calculated in our paper the only number that we could come up [with], in terms of translating to a cigarette tax, of the medical cost of hospitalization, which I think was about one-tenth to three-tenths of a percent per pack. But I want to say with respect -- there's a couple of observations you can make about children. A lot of this is going to occur in the home and with the parents, if it does occur, and a place that I think is beyond the reach of regulation. SENATOR LAUTENBERG: Yeah, but now you're getting into the health-analysis side of things, which you said you didn't want to. DR. GRAVELLE: I'm sorry. SENATOR LAUTENBERG: I mean, you wanted to focus... DR. GRAVELLE: I said I think that's beyond the reach of regulation. I I I I I I I I I I I I I I I