Reports that Matter

United States v. Philip Morris USA Inc.: Amended Final Opinion

JAPANESE SPOUSAL STUDY IEMC PAPERS

Section 87 of 129

JAPANESE SPOUSAL STUDY IEMC PAPERS

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  1. Lee did the statistics. 2. The Japanese scientists have "drifted away" from Proctor; the paper will be published but will be much weaker than Peter Lee's previous draft. 3. Proctor has written a paper and has sent it to them for their review 4. Peter Lee could still publish his paper w/o Japanese 5. Neither draft recognizes no [sic] funding source nor that RJR did the analyses 6. Proctor -- some concern that the Japanese scientists will talk about the tob. Industry involvement. 7. One of the Jap. Scientists is "lost completely" (Nigawa sp?) but Yano is still close to Proctor

2501003237-3242 at 3239-3240 (US 22320).

  1. Yano, the remaining Japanese researcher recruited by Covington & Burling, backed out soon thereafter, forcing Defendants to look to Lee as the sole author of the study. 2023544546 (US 22925).

  2. Philip Morris IEMC representative Helmut Reif wrote in his June 24, 1993 "Monthly Activities" that the Japanese scientists had become "uncomfortable" with Lee's conclusions. 2028372583-2596 at 2595 (US 22926).

  3. A later Philip Morris report from Helmut Reif recorded that one of the Japanese consultants recruited to be an author voiced his belief that the findings were not supported by the data, that Lee had changed the data in a rewritten paper, and that he felt "threatened" by the tobacco industry. The following is an excerpt from Reif's November 29, 1994 "Monthly Activities" report:

(1) Japanese Spousal Study

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History: A[dlkofer] visited together with Wynder the Japanese author on behalf of the spousal study. (Authors refused to publish under their name, PNL [Peter N. Lee] rewrote it, editors of "Preventive Medicine" found it not matching their journal, Int.Arch.Occ.Med, Adlkofer took it over, however, had hesitations. Prof. Feinstein wanted answers to some detailed questions before publishing it).

Results: Author Yano reported that he was shown around to several ETS conferences by Proctor and afterwards, Proctor withdrew. Author [Yano] never thought he would have to publish this study and distanced himself from the paper by the following arguments:

(a) Misclassification was not 30% -- PNL calculated on the basis of active smokers, not on the basis of passive smokers -- but only 10%, and this was counterbalanced by a similar misclassification from the other side - nonsmokers wrongly claiming to be smokers.

(b) He feels threatened by the industry . . .

2028372914-2915 at 2915 (US 22324).

  1. After the Japanese scientists backed out of the project, the paper (now listing Lee as the sole author) remained unpublished through 1994. The British Medical Journal and the American

Journal of Epidemiology rejected the paper for publication. Blackie WD, 62:21- 63:4; 20242106540658 (US 22866).

  1. The American Journal of Epidemiology (AJE) rejected the paper on the basis of flaws that, in its view, could not be remedied. The editor-in-chief informed Lee in his May 17, 1994 letter:

Both reviewers found the overall response rate of 33% to be unacceptable, particularly since generalizations are made to population-based studies. Furthermore, the sampling approach is not adequately described and a "semi-random" approach may not be unbiased. Can the results obtained in the 1990s be extrapolated to the

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reported studies, particularly the cohort study of Hirayama in which the smoking information was collected decades earlier?

The reviewers also questioned the basis of the estimation of the misclassification bias and the criteria used to select the factors that you considered as potential confounding factors. Both reviewers identified a number of other limitations of the manuscript, including errors in the tables and possible miscalculations. Given the low response rate, revision would not address the principal concern of the two reviewers.

2024210654-0658 at 0654 (US 22866). The reviewer went on:

Even if the results of the current study are deemed valid and generalizable, the conclusions as summarized in the abstract are not supported by the data generated in the study. . . . Smokers married to non-smokers were significantly more likely to lie about their smoking status than were smokers married to smokers (64% versus 17%, P=0.002). Thus the bias implied by the actual data generated in this study is a negative bias, which does not support the statements in the abstract to the effect that results from passive smoking studies in Japan are invalid and that the increased risk reported is probably due to bias from smoking misclassification (i.e., smokers lying about their smoking status). Of course, the finding that smokers married to nonsmokers are more likely to lie is no more reliable than any other finding in this study given the low response rate.

2024210654-0658 at 0655 (US 22866).

  1. In fact, Lee himself stated in the abstract of this unpublished version that: "Major findings were that over 30% of smokers (judged by existence of the biomarker for nicotine, cotinine) denied smoking, a much higher rate than reported in Western studies; denial rates were higher for women married to non-smokers" rather than for women married to smokers. Accordingly, as noted by the AJE reviewer, Lee's data supported the conclusion that the reported risks in the Japanese epidemiological studies would be even higher but for the smoking misclassification. 20242106320652 at 0634 (US 22865). Such a conclusion would have been directly contrary to the conclusion sought by Defendants.
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  1. Lee sent the rejection letter and reviewers' comments under cover letter dated May 23, 1994, to Proctor (with copies to executives at Imperial Tobacco and Gallaher) with a recommendation that the paper be rewritten. 2024210653-0653 (US 22867).

  2. Lee clung to his conclusion that misclassification bias could explain the raised lung cancer risks reported in the Japanese epidemiological studies. Long-time industry consultant, Franz Adlkofer's International Archives of Occupational and Environmental Health published Lee's Japanese Spousal Study paper in April 1995. The paper concluded that high rates of misclassification "undermine conclusions from epidemiological studies conducted" in Japan. The final published version of Lee's Japanese Spousal Study paper did not disclose the fact that "denial rates were higher for women married to non-smokers." 9000006054-6061 at 5054 (US 57902*).

  3. Lee's paper acknowledged the "financial support from several companies of the tobacco industry." 9000006054-6061 (US 57902*).

  4. Defendants and their consultants cited Lee's conclusions from the Japanese Spousal Study in support of the industry position that there were no proven health effects associated with ETS, the epidemiology was flawed, and the question was still open. The original plan had been to generate a paper "to undermine Hirayama conclusions in time for the EPA [Risk Assessment]." 2023522351-2352B (US 75127). However, because the project was not completed and published until 1995, it was instead used to critique the 1994-1995 OSHA proposed rulemaking. At the request of the Tobacco Institute, Lee submitted comments dated July 1994 and November 1995 to OSHA. Lee asserted in his comments that he was "an Independent Consultant in Statistics and

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Epidemiology, providing advice to a wide range of clients, including the tobacco industry." He then cited the Japanese Spousal Study as support for his opinion that misclassification bias is a major flaw in Japanese epidemiological studies. TIBR0006738A-TIBR0006754 at 6750 (US 62553); TIBR0000567-0590 at 0568 (US 85817).

(2) The 1989 Malmfors/SAS Airline Study 3753. In the late 1980s, the issue of airline smoking restrictions was gaining increased

attention from public officials. In 1986, Congress requested a report by the NRC to the FAA concerning the smoking sections on airplanes. In that report, "The Airliner Cabin Environment: Air Quality and Safety," the NRC recommended "a ban on smoking on all domestic commercial flights, for four major reasons: to lessen irritation and discomfort to passengers and crew; to reduce potential health hazards to cabin crew associated with ETS; to eliminate the possibility of fire caused by cigarettes; and to bring the cabin air quality into line with established standards for other closed environments." (no bates) (JD 024863 at 6-7). This recommendation was followed by the passage of legislation in 1987 directing the Secretary of Transportation to restrict smoking on domestic flights with a scheduled flight time of two hours or less. 2501042537-2541 at 2537 (US 89402); see 29 U.S.C. App. § 1374(d).

  1. SAS airlines announced in late 1987 that it was planning to ban smoking on domestic Swedish flights as a test in the summer of 1988. Finnair had already decided to ban smoking on all domestic flights and permit only smoking breaks on international flights. 2501042537-2541 at 2537 (US 89402).

  2. In 1988, Philip Morris decided to carry out its own airline cabin testing for ETS, with the objective to "persuade the management of airlines to adopt policies which permit smokers to enjoy cigarettes during flight." Philip Morris's Mary Pottorff was assigned to be project leader, Rupp was tasked to select researchers to participate in the study. 2501042537-2541 at 2537, 2539 (US 89402).

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  1. In a July 5, 1988 memorandum to Philip Morris's Andrew Whist in New York, Pottorff wrote that SAS had agreed to permit the air cabin testing and that the project would be funded by Philip Morris, Reynolds, and the Swedish cigarette manufacturers association. Pottorff further advised that three industry consultants would participate in the study, and that the air samples would be tested at a Dutch laboratory called TNO. Torbjorn Malmfors Toxicologist, Karolinska Institute, Sweden, would then write the paper with the other two consultants. A September 2, 1988 letter from interim CIAR director Guy Oldaker to Chris Proctor stated that BATCo was funding the project with the other companies. 2501042534-2535 (US 90037); 508220128-0128 (92022).
  1. Philip Morris elected to finance the SAS study through CIAR: The official funding of IFAQ [in flight air quality] research can be the Center for Indoor Air Research (CIAR) in Washington, D.C. There are two benefits from this vehicle, namely all contributions to fund the research can be processed by CIAR staff & CIAR can then be correctly named as a sponsor of the research -- which will diminish the effectiveness of the antis PR efforts to challenge the credibility of the research.

2501458517-8519 at 8518 (US 25615).

  1. John Rupp recruited Malmfors as an ETS consultant for Philip Morris. Rupp advised that Malmfors "does not believe that any adverse health effects [of ETS] have been shown" and was ready to take the "next step in the process" and meet with the tobacco industry directly. 2023543320-43321 (US 90036); 2023034933-4946 at 4939 (US 87334).
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  1. The Dutch laboratory TNO took air samples aboard a number of SAS aircraft during the month of September 1988. TNO analyzed the samples for ETS components and prepared a "Confidential" report of its results to CIAR dated December 16, 1988. This report included an "Analysis of the Results" section (pages 20-42) where the authors concluded that the particulate and carbon dioxide levels on the SAS aircraft were not only high, but exceeded WHO and hygienic standards on many of the flights. The authors also found that there was little difference in ETS and air quality between the smoking sections and one of the nonsmoking sections. 89816305-6347 at 6343-6346 (US 90043).

  2. Gaisch recorded in his October 1988 monthly report that he had seen the TNO data, and noted that the high carbon monoxide levels were "an indication that the air in the aircraft cabin does by no means meet the ASHRAE standards (US norm for quality of indoor air)" and that the separation of smokers and nonsmokers was "nearly immaterial" to the air quality. 2501152077-2091 at 2088-2089 (US 25597).

  3. On January 3-4, 1989, Philip Morris, R.J. Reynolds , and Lorillard met with the three Swedish consultants and Max Eisenberg at Covington & Burling. The group agreed that "the RSP data was unexpectedly high" and that the testing pads should be reanalyzed at a laboratory in the United States, even though the pads were three months old. 2501255448-5448 (US 90046).

  4. The group "was not too comfortable with the way Malmfors had presented the data" and asked Rupp to talk to Malmfors about a "better approach." On January 4, "Rupp reported that Malmfors was agreeable to such an approach." 2501255448-5448 (US 90046).

  5. In his handwritten notes of the January 3, 1989 meeting at Covington & Burling, Tom Osdene wrote that the report's "explanations" were "inappropriate," and that the solution was to

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"remove the discussion" section. 2023528894-8895 at 8895 (US 90035). In his notes of the January 4 meeting, Osdene wrote that the TNO report would be "discarded" and a "revised final version" would be prepared. 2023528896-8899 at 8898 (US 92036).

  1. Helmut Gaisch's report of the meetings recorded the following: [I]t was decided by a majority that (1) the exposed filter pads should be sent to Dr. Max Eisenberg, CIAR, who will find a US-based laboratory to carry out the UV-PM analysis, (2) All chapters of the narrative part of [the] TNO [report], going beyond mere description of the experimental part, should be eliminated.

2501152038-2052 at 2044-2045 (US 90044).

  1. TNO prepared a second report for CIAR dated January 23, 1989. This revised report entirely eliminated the 22-page "Analysis of the Results" section from the earlier report. 506848666- 8687 (US 90047).

  2. Malmfors sent his second draft to Rupp, U.S. industry consultants, and CIAR by February 3 for review. 87823747-3750 at 3749 (US 85695).

  3. Defendants were apparently still not satisfied with Malmfors' paper. Philip Morris's Helmut Reif summarized a meeting between Malmfors and industry representatives (including Pottorff, Proctor, Green, Reif, and Covington & Burling attorney Charles Lister) in Stockholm on March 21, 1989, where Malmfors presented his revised findings. Industry representatives apparently tried to pressure Malmfors to change his results even further, at which point the following occurred:

As the discussion got too tight, Malmfors said that he would not change his opinion, but there were other experts who could do his job.

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  1. The SAS study was finally published, titled "Air Quality in Passenger Cabins of DC-9 and MD-80 Aircraft," in industry consultant Roger Perry's journal Environmental Technology Letters. The published version concluded that : "The total exposure to cabin air ETS among the passengers is rather small and insignificant in comparison to total life exposure to air pollution," and that an effective ventilation system could maintain air quality in airline cabins. 87630985-1000 at 0998 (US 23522).

  2. Despite the fact that Malmfors and his listed co-authors were consultants to Philip Morris, the published paper stated: "The authors have served as consultants to CIAR." 2023528820- 8893 at 8821, 8863, 8868 (US 92028); 87630985-1000 at 0999 (US 23522).

  3. The Malmfors/SAS project was funded through CIAR at a cost of $638,806. 2505442777-2960 at 2861 (US 25643*). While the published paper did acknowledge the funding from CIAR, there was no mention of the source of CIAR funds, or the involvement of tobacco industry scientists and lawyers in the planning, management, and execution of the study, as well as the writing of the published paper. 87630985-1000 (US 23522).

  4. The Malmfors/SAS paper was cited by Defendants in submissions to regulatory agencies, including the Federal Aviation Agency, in support of its position that no regulation of smoking in aircraft was required beyond separation of smokers and nonsmokers. 2024191369-1381 at 1375-1376 (US 89401); 2023216588-6626 at 6594 (US 87407).

  5. Industry consultants HBI and Gary Huber cited the Malmfors study to the EPA in their comments opposing to the ETS Risk Assessment. 87653565-6820 at 4753-4763 at 4762, 5519-

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(3) The 1992 HBI 585 Building Study 3773. In 1989, CIAR funded a project by industry consultant "Gray" Robertson and HBI

(see supra Section V(G)(6)(a)((6))((h))) to assess indoor air quality and ETS in offices. The project cost $138,387 and resulted in the 1992 published paper "The Measurement of Environmental Tobacco Smoke in 585 Office Environments" (the "585 Building Study"). The paper concluded that ETS components in "typical office workspaces" were lower than had been previously reported. 2505528777-8786 at 8786 (US 20572); 2505442777-2960 at 2895 (US 25643*).

  1. In conducting the study, HBI falsified and manipulated the data. HBI field technician Gregory Wulchin testified at trial that he conducted a number of the ETS inspections underlying HBI's published 585 building study. Wulchin WD, 6:13-7:1. Wulchin examined eight of his ETS field reports that were included in the data underlying the published paper and found that false data entries had been made. Wulchin WD, 7:2-13:12; TLT0600139-0217 (US 65101). Wulchin testified that at least one of his data sheets had been altered by Robertson. Wulchin WD, 3:21-5:16; TLT0600139-0217 at 0154 (US 65101); Wulchin TT, 11/3/04, 4855:5-4859:10. Wulchin identified similar errors transposing several other data recordings that had been made by other HBI technicians. Wulchin WD, 13:13-16:14. In addition, Wulchin testified that the readings in two of his field reports demonstrated unacceptably high levels of particulate from cigarette smoking in rooms where there was good ventilation. Wulchin WD, 16:19-17:8. As a result of these irregularities and others, Wulchin testified, "My experience with HBI data as well as [my] review of HBI reports, leads me to conclude that HBI's data contained unexplained entries that raise serious questions about the integrity of its studies." Wulchin WD, 17:9-14. The Court credits his testimony for the following reasons: Wulchin was a former employee who harbored no animus against HBI; he had nothing to gain from testimony that was adverse to HBI; his testimony was specific and internally consistent; under cross-examination, he was neither evasive nor hostile.
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  1. After the 585 Building Study was published, the results and data were the subject of a 1994 Congressional examination. Robertson WD, 89:4-8; 2047330959-0981 (US 38593). The Subcommittee on Health and the Environment obtained HBI's then-existing ETS data forms and compared them to the data that was submitted in an interim report to CIAR. Robertson WD, 90:10; TLT0600053-0084 (US 65097) (interim submission to CIAR). Discrepancies were identified that would have affected the levels of ETS reported by HBI's study. Wulchin confirmed that HBI's data collection forms were often changed to minimize measurements of ETS.

It is my belief that there were other instances in which HBI reduced field measurements of high levels of particulates in rooms where smoking occurred. . . . I conducted a number of tests summarized in the CIAR report. My review of the report indicates that HBI mischaracterized and made numerous alternations in the data I collected.

Wulchin WD, 3:11-20, 5:2-13; TLT0600139-0217 at 0140 (US 65101).

  1. Some of the criticisms made by HBI employees and tobacco industry scientists about HBI methodology were also made by James Repace, EPA, and Alfred Lowery, Naval Research Laboratory, widely published authors on ETS and indoor air quality, in a 1992 letter to the editor shortly after the 585 Building Study was published. For example, from the data provided in the paper, Repace and Lowery were able to determine that HBI took measurements of smoking areas within larger rooms, and HBI did not report the volume of any rooms in which readings were taken.
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  1. In addition, Repace and Lowery criticized the lack of science underlying the study: air exchange rates were not reported; the number of buildings was not reported; the locale of the buildings was not reported; the types of buildings were not reported; the ages of the buildings were not reported; the types of air handling systems were not reported; the time of year recordings were made was not reported; the proximity of the detector to smokers was not reported; and there was no discussion of or comparison with earlier findings, as would normally be the case in scientific studies. 2505583630-3641 (US 85640); see also VXA1601456-01742 at 1651-1652 (US 64059) (1984 Surgeon General's Report, stating number of cigarettes burned, the size of the room, the effective ventilation rate, and smoke residence time are all important variables in determining levels of secondhand smoke exposure); VXA2110670-1053 at 0823-0826 (US 63709) (1986 SGR).

  2. Defendants themselves recognized the flaws in Robertson's scientific methodology. In April 1991, even before the allegations of scientific fraud publicly surfaced the following year (2070332077-2104 (US 85627)), CIAR Board members Spears (Lorillard), Green (Reynolds), and Pages (Philip Morris), discussed a proposal by HBI to gather additional data related to ETS and indoor air quality. CIAR rejected funding the proposal because it lacked scientific merit. 87776361- 6362 (US 56325); 87776358-6359 (US 56324).

  3. Despite the evidence of scientific fraud, in March 1992 the Tobacco Institute cited the 585 Building Study as scientific authority in its comments opposing adoption of OSHA's IAQ Rule. TI02120021-0098 at 0035 n. 32 (US 65685*); see also (no bates at 91) (JD 023792), (Reynolds' 1992 OSHA submission). As recently as 2000, the HBI paper was cited by industry consultant Roger Jenkins in a journal article. (no bates at 49) (JD 065013); BR2000545-0785 at 0658 and 0670 (JD 065024).

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  1. The published paper on the 585 Building Study acknowledged, "Funding for this work was made available in part by the Center for Indoor Air Research, Linthicum, Maryland." (US 20572). As detailed above (see supra Section V(G)(6)(a)((6))((h))), this statement does not provide the reader an accurate picture of Robertson/HBI's long-standing, lucrative financial relationship with the tobacco industry.

(4) The 2003 Enstrom/Kabat Study 3781. James Enstrom's May 2003 article, "Environmental tobacco smoke and tobacco

  1. A June 25, 1996 Philip Morris e-mail from Marc Firestone to Richard Carchman stated that Enstrom did work for Philip Morris and Reynolds "in the context of the EPA litigation," and that one of his new proposals was "clearly litigation oriented" and should be "pursued, if at all, in the context of attorney work product." 2063610699-0699 (US 27128).

  2. Enstrom then sent his first proposal to perform statistical analyses on data from CPS I to CIAR on July 15, 1996, stating:

For the past three years I have done consulting and research for Jeffrey L. Furr of Womble Carlyle on behalf of R.J. Reynolds and Philip Morris. This research has found a number of results that raise serious questions about several published findings on the relationship of passive smoking to lung cancer and other diseases.

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2063610840-0841 at 0840 (US 85796). Enstrom also stated in his July 15, 1996 letter to Eisenberg that his proposed CIAR research would "continue and expand upon" the research done for Womble Carlyle. 2063610840-0841 at 0840 (US 85796).

  1. At a November 1996 meeting, the CIAR Board of Directors discussed the Enstrom proposal and noted that Philip Morris lead scientist Richard Carchman and Reynolds lead scientist Charles Green (two members of the CIAR Board) had already visited Enstrom at UCLA to discuss the proposal with him personally. 2063650515-0518 at 0515 (US 79212).

  2. Enstrom wrote a January 15, 1997 letter following up on his proposal but directly to Carchman at Philip Morris, rather than to CIAR or its SAB:

A level of trust must be developed based on my past research on passive smoking and epidemiology in general in order to work out the best way for me to conduct this research. A substantial research commitment on your part is necessary in order for me to effectively compete against the large mountain of epidemiologic data and opinions that already exist regarding the health effects of ETS and active smoking.

2063654073-4073 (US 85811).

  1. According to the minutes of the May 15, 1997 CIAR Board of Directors meeting, CIAR found a co-author collaborator for Enstrom, Geoffrey Kabat. 517578187-8188 (US 85816).

  2. By letter from Carchman dated April 25, 1997, Philip Morris agreed to fund a precursor study by Enstrom for $150,000. 2063610867-0867 (US 85787). That same year, Enstrom received funding from CTR, via a letter that proposed paying him an additional $25,000 in addition to an ongoing CTR grant already in place. 40001769-1769 (US 85804*).

  3. Enstrom's second proposal to CIAR, dated October 20, 1997, resulted in funding of at least $525,000 from Defendants, a 1998 contract with CIAR as an Applied Project. 5669435493579 at 3550 (US 85813); 2505442777-2960 at 2815 (US 25643*); 83205526-5581 at 5538 (US 92033); Eisenberg TT, 11/9/04, 5630:22-5631:8; 2505442777-2960 (US 25643*); 83205526-5581 at 5538 (US 92033); Eisenberg TT, 1/9/04, 5630:22-5631:8; 2505442777-2960 (US 25643*).

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  1. As originally planned, the researchers conducted a study using California CPS I data to ascertain rates of reported cases of coronary heart disease, lung cancer, and chronic obstructive pulmonary disease for study participants identified as "never smokers married to smokers." The study yielded the following results: never smokers married to smokers had a relative risk of 0.94 for developing coronary heart disease and 0.75 for developing lung cancer. Thus, according to the study, the relative risk of developing coronary heart disease and lung cancer decreased for never smokers married to smokers. Based on these results, the researchers concluded that there is no significant association between passive smoking and tobacco-related diseases in never smokers married to smokers. TKT0500029-0038 (US 65086).

  2. When the Enstrom/Kabat paper was published in the May 2003 issue of the British Medical Journal, it was roundly criticized in the scientific community. Members of the 2002 working group on involuntary smoking and cancer for the International Agency for Research on Cancer (IARC) made the following statement:

Enstrom and Kabat's conclusions are not supported by the weak evidence they offer, and although the accompanying editorial alluded to "debate" and "controversy", we judge the issue to be resolved scientifically, even though the "debate" is cynically continued by the tobacco industry.

(no bates) (JD 024496). The American Cancer Society had repeatedly warned Enstrom that using its CPS-I data in the manner he was using it would lead to unreliable results. Enstrom used only a small subset of the overall data, and, more importantly, the data corresponded to participants who enrolled in 1959, a time when exposure to tobacco smoke was common. TLT0961621-1623 (US 86735); (no bates at 502-503) (JD 024502).

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  1. Defendants nevertheless promoted the study. For example, in October 2003, BATCo cited the report on its website in support of its position that "the claim that ETS exposure has been shown to be a cause of chronic disease is not supported by the science." BATCo stated that a "very large study published in the British Medical Journal in May 2003 on environmental tobacco smoke in the home has found no increases in risk for the key smoking related diseases." The website provided a hyperlink to BAT's summary of the study:

In our view, this is an important study which confirms that many of the estimates of the risks of public smoking are overstated in the extreme, and that considerable doubts remain as to whether ETS exposure is associated with any risk of chronic diseases such as lung cancer and heart disease. We believe the study illustrates that calls for bans on public smoking cannot be justified on the basis of the suggestion of chronic health risk for non-smokers, although of course we believe that the needs of non-smokers should be also catered for with solutions such as good ventilation.

ARG0412302-2303 (US 86747); TLT1020487-0488 (US 88461).

  1. In the present litigation, Defendants' statistician Edwin Bradley relied on the Enstrom paper as evidence that bias and confounding explain the elevated observed risks in epidemiological studies finding an association between spousal smoking and lung cancer. Bradley WD, 100:36-
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