Reports that Matter

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

Developments Between 1953 and a. Between 1953 and 1964, the Evidence Demonstrating that

Section 44 of 129

Developments Between 1953 and a. Between 1953 and 1964, the Evidence Demonstrating that

Smoking Causes Significant Adverse Health Effects Grew Although No Consensus Had Yet Been Reached 570. During the 1950s, the evidence implicating smoking as a cause of lung cancer

continued to grow. The published research employed different methodologies and was reported in well-respected peer reviewed journals. Id. at 66:10-73:10. Such research utilized clinical observation, population studies and laboratory investigation, all of which, alone or in combination, are traditional methods of scientific investigation. Brandt TT, 9/27/04, 643:5-652:11.

  1. During the late-1950s, particularly 1957-1959, the scientific and medical evidence was mounting that smoking causes disease. However, there was still ongoing debate amongst respected and independent researchers and public health experts about both the substantive evidence showing causation and about the proper technical terminology to describe the degree of association between smoking and the disease.

  2. Even as the evidence mounted demonstrating the causal link between smoking and disease, scientists equivocated on the exact nature of such causation. For example, in 1956, Dr. C.S. Cameron, the Medical and Scientific Director of the American Cancer Society ("ACS"), wrote an article, appearing in The Atlantic, on the history and ongoing research on smoking and lung cancer, which stated:

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Most of the scientists who have given thought and study to the matter appear to agree that an association between cigarette smoking and cancer of the lung does exist. Whether that association is one of cause and effect is as yet unanswered in terms of major scientific opinion. . . . [The American Cancer Society] does not hold that smoking causes cancer of the lung.

(no bates) (JD 000310 at 71, 75) (C.S. Cameron, Lung Cancer and Smoking: What We Really

Know, The Atlantic, 197(1):71-75 (Jan. 1956)). Cameron went on to state, however:

The American Cancer Society, along with a growing body of professional and scientific opinion, has taken this position: Although the complicity of the cigarette in the present prevalence of cancer of the lung has not been proved to the satisfaction of everyone, the weight of evidence against it is so serious as to demand the stewards of the public welfare that they make the evidence known to all.

Id.

  1. The debate on causation in the 1950s stemmed from those who believed that a causal judgment required experimental confirmation. Brandt TT, 9/27/04 at 726:13-21. For example, one respected researcher wrote: "proof is lacking and will remain absent until it becomes possible to produce cancer experimentally from some or all of the products contained in cigarette smoke." (no bates) (JD 002521 at 267) (E. Graham, Primary Cancer of the Lung With Special Consideration Of

Its Etiology, Bulletin of the New York Academy of Med., 27:261-76 (1951)). As one article explained it, many scientists were skeptical of the epidemiologic evidence:

There is a history of skepticism toward field-based population studies, in contrast with studies performed in the laboratory . . . the epidemiologic and biostatistical techniques used in the retrospective studies of smoking and lung cancer were relatively new. Skepticism and misunderstanding of this new methodology played an important role in the debate over the health effects of cigarettes.

The article also states:

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[T]he surgeon general and US Public Health Service (PHS) scientists had concluded as early as 1957 that smoking was a cause of lung cancer, indeed, "the principle etiologic factor in the increased incidence of lung cancer." Throughout the 1950s, however, the PHS rejected further tobacco-related public health actions . . . . It was not until pressure mounted from outside the PHS in the early 1960s that more substantive action was taken. Earlier action was not taken because of the way in which PHS scientists (particularly those within the National Institutes of Health) and administrators viewed their roles in relation to science and public health.

(no bates) (JD 004238 at 197) (M. Parascandola, Public Health Then and Now: Cigarettes and the US Public Health Service in the 1950s, Am. J. Pub. Health, 91(2):196-205 (2001)). In this good faith, professional debate, scientists seeking such experimental confirmation did not doubt the causal link between smoking and disease but rather doubted that it had been proven with scientific rigor. Brandt WD, 67:19-68:19.

  1. Given this diversity of views amongst respected and independent scientists, the Court does not find, as the Government has argued, that, as of the mid-1950s, a consensus had yet been reached on whether cigarette smoking "caused" -- in the precise scientific meaning of that term -- cancer.

  2. In 1956, at the urging of Surgeon General Leroy Burney, a Study Group on smoking and health was organized by the American Cancer Society, the American Heart Association, the National Cancer Institute, and the National Heart Institute. This group of distinguished experts met regularly to assess the character of the scientific evidence relating to tobacco and health. At that time, the Group noted that sixteen studies had been conducted in five countries all showing a statistical association between smoking and lung cancer. Among the studies they summarized, it was demonstrated that: lung cancer occurs five to fifteen times more frequently among smokers than nonsmokers; on a lifetime basis one of every ten men who smoke more than two packs a day will die of lung cancer; and cessation reduces the probability of developing lung cancer. VXA2510023- 0027 (US 63610) (Strong, Frank M., et al., Smoking and Health: Joint Report of the Study Group on Smoking and Health, Science, 125:1129-1133 (1957)); Brandt WD, 69:22-71:7.

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  1. The Group also noted that the epidemiological findings were supported by animal studies in which malignant neoplasms had been produced by tobacco smoke condensates. Further, human pathological and histological studies added evidence to strengthen the "concept of causal relationship." The authors concluded:

Thus, every morphologic stage of carcinogenesis, as it is understood at present, has been observed and related to the smoking habit. The sum total of scientific evidence establishes beyond reasonable doubt that cigarette smoking is a causative factor in the rapidly increasing incidence of human epidermoid carcinoma of the lung.

VXA2510023-0027 at 0023 (US 63610) (Strong, Frank M., et al., Smoking and Health: Joint Report of the Study Group on Smoking and Health, Science, 125:1129-1133 (1957)); Brandt WD, 69:22- 71:7.

  1. However, the Study Group's judgment that smoking causes disease was not widely accepted. Dr. Michael Shimkin, a PHS researcher and a member of the Study Group, stated the Study Group's report "created no particular stir . . ." and was not widely accepted outside of the group itself. (no bates) (JD 060636) (Shimkin, M.B., In the Middle: 1954-63 – Historical Note, JNCI 62(5)-1295-1317 (May 1979)). Some of the very organizations which had sponsored the Study Group, including the National Heart Institute and the American Heart Association (US 63610 at 1129), did not accept its report as "sufficiently convincing." (no bates) (JD 060636 at 1297)).
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Individual scientists within NCI disagreed with the Group's conclusion, and there was definitely no clear consensus at NCI on the issue. Brandt TT, 9/27/04, 712:25-713:5, 715:9-16.

  1. In 1957, NCI's Director, John Heller, gathered together the chiefs of four major NCI sections, Drs. Gilliam (Chief of Epidemiology), Hueper (Chief of the Environmental Cancer Section), Shear (NCI's expert on carcinogenesis), and Stewart (NCI's head pathologist) to determine their stance on the issue of whether smoking caused disease. He "received more denials than support." (no bates) (JD 060636 at 1298) (Shimkin, supra). "[T]heir paradigm of cancer research simply did not encompass the epidemiologic method." Id. Thus they "refused to recognize epidemiologic data that were not confirmed in laboratory animals." Id.

  2. Because of the dissension within NCI over the causation issue, and its refusal to accept the conclusions of the Study Group, Surgeon General Burney appointed Dr. Lewis Robbins to be NCI's point person to deal with the issue of causation. Brandt TT, 9/27/04, 716:2-15; see also (no bates) (JD 060636 at 1298) (Shimkin, supra) ("[Burney] then ordered a fuller account to be prepared for his signature; this task was assigned to Dr. Lewis Robbins. . . .").

  3. Dr. Robbins's first task was to write a brochure for physicians on smoking and lung cancer. Brandt TT, 9/27/04, 720:23-721:5; (no bates) (JD 004252 at 609). As the brochure "went through numerous reviews at the National Cancer Institute throughout the next 16 months" (no bates) (JD 004252 at 609), Dr. Robbins faced internal opposition. Within NCI's Carcinogenesis Branch, Drs. Hueper (Chief of the Environmental Cancer Section), Shear (NCI's expert on carcinogenesis) and Stewart (NCI's head pathologist) all opposed publication because they "disagreed with any emphasis that cigarette smoking induced lung cancer." Id. at 610.

  4. In 1961, the editors of The New England Journal of Medicine stated that while:

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the editors of the Journal have on occasion revealed their own suspicion that one side of this controversy is probably the one to which to cleave, it is perhaps not completely judicious for them to offer any extraneous comments at this time that might seem to favor either faction.

It is enough to say that most of the evidence is statistical and demonstrates a close association between heavy cigarette smoking and lung cancer.

Many conscientious observers believe that there are strong indications in favor of a causal relation in the vast majority of cases. . . . Others remain unconvinced. . . . Each individual must choose his own course, whether to woo the lady nicotine or abjure the filthy weed, while the search for truth continues.

(no bates) (JD 020447).

  1. Based on the Study Group's review of existing material, Dr. Robbins's brochure, and subsequent research results, Surgeon General Burney believed in 1959 that the link between smoking and disease was significant and that, as a result, there were important and timely opportunities to prevent disease:

The Public Health Service believes that the following statements are justified by studies to date.

  1. The weight of evidence at present implicates smoking as the principal etiological factor in the increased incidence of lung cancer.
  1. Cigarette smoking particularly is associated with an increased chance of developing lung cancer.
  1. Stopping cigarette smoking even after long exposure is beneficial.
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  1. No method of treating tobacco or filtering the smoke has been demonstrated to be effective in materially reducing or eliminating the hazard of lung cancer. 5. The nonsmoker has a lower incidence of lung cancer than the smoker in all controlled studies, whether analyzed in terms of rural areas, urban regions, industrial occupations, or sex. 6. Persons who have never smoked at all (cigarettes, cigars, or pipe) have the best chance of escaping lung cancer. 7. Unless the use of tobacco can be made safe, the individual person's risk of lung cancer can best be reduced by elimination of smoking.

VXA2510046-0054 at 0052-0053 (US 63608) (Burney, Leroy E., Smoking and Lung Cancer: A Statement of the Public Health Service, JAMA, 71: 1828-1837 (1959)); Brandt WD, 76:13-77:21.

  1. While Dr. Burney believed the link between smoking and disease was significant, his article did not come to a categorical conclusion. The PHS itself labeled Dr. Burney's conclusion "weasel words" that were necessitated by the strong disagreement over the issue within the agency itself. Brandt TT, 9/27/04, 707:4-708:3, 722:1-12; (no bates) (JD 022706 at 1) (Letter from L.C. Robbins, M.D., Chief, Cancer Control Program, to H.S. Diehl, M.D. (July 8, 1960)). The debate over what was proof of a "cause" is unmistakable in the early drafts of the Surgeon General's 1959 statement. To try to reach agreement on how the PHS would describe the evidence and the relationship, a number of drafts were circulated. (no bates) (JD 004252 at 611). Weeks before publication, in a November 1959 draft marked "final," the PHS planned to state that the area was "highly controversial," that there was "no scientific proof" of causation, and that the Surgeon General's article would "admit[] this":

[W]e feel justified to make a further observation which seems pretty well established. There exists no scientific proof that smoking causes

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lung cancer. Even the Surgeon General's special article admits this. . . . Today we have this "coincidence" of a statistical relationship between smoking and lung cancer. The pathological evidence of the relationship between the two, if not weak, is at least highly controversial.

(no bates) (JD 020373 at 1).

  1. The dissent over the issue also led to PHS publication of an editorial opposing the Surgeon General's own article, which was published two weeks later. (no bates) (JD 023196) (at Tab 7); Brandt TT, 9/27/04, 722:13-723:4, 724:9-15 (written because of disagreement within Surgeon General's office and NCI). The editorial criticized Surgeon General Burney's statement on two related grounds. First, it acknowledged disagreement over its conclusion:

A number of authorities who have examined the same evidence cited by Dr. Burney do not agree with his conclusions.

Second, it pointed out the lack of evidence to support an authoritative position:

Neither the proponents nor the opponents of the smoking theory have sufficient evidence to warrant the assumption of an all-or-none authoritative position.

(no bates) (JD 000716 at 2104) (Smoking and Lung Cancer, JAMA, 171(15):2104 (1959)). See also Brandt TT, 9/27/04, 722:13-723:30.

  1. In addition, outside of the public health community, surgeons and pathologists published clinical reports associating cancer in their patients with their smoking habits. In 1957, Oscar Auerbach and his colleagues first reported in the New England Journal of Medicine on "Changes in the Bronchial Epithelium in Relation to Smoking and Cancer of the Lung." Auerbach's study evaluated patients with confirmed smoking histories who died and were autopsied. In order to avoid any potential bias, microscopists were kept ignorant of the smoking histories in the 30,000 examinations that they made. Auerbach and his co-authors concluded:
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These findings are fully consistent with the hypothesis that inhalants of one sort or another are important factors in the causation of bronchogenic carcinoma. The findings are also consistent with the theory that cigarette smoking is an important factor in the causation of bronchogenic carcinoma.

Auerbach presented additional confirmatory findings in 1961 and 1979. 682628764-8771 at 8771 (US 54185) (Auerbach, Oscar, et al., Changes in the Bronchial Epithelium in Relation to Smoking and Cancer of the Lung: A Report of Progress, New England Journal of Medicine, 256.3:97-104 (1957)); VXA2511322-1328 (US 63538) (Auerbach, Oscar, E. Cuyler Hammond, and Lawrence Garfinkel, Changes in the Bronchial Epithelium in Relation to Cigarette Smoking, 1955-1960 vs. 1970-1977, New England Journal of Medicine, 300.8:381-386 (1979)); Brandt WD, 63:14-64:11.

  1. During the same time period, E. Cuyler Hammond and Daniel Horn conducted a massive epidemiological study of smoking and lung cancer under the auspices of the American Cancer Society. In the Hammond and Horn study, more than 200,000 men were followed prospectively for nearly four years; during this period 12,000 died. The authors found that not only was lung cancer far more prevalent as a cause of death among those who smoked (twenty-four times more than nonsmokers), so too were heart disease and circulatory disease. Hammond and Horn estimated that among smokers, smoking might account for up to 40% of their mortality. VXA2510028-0045 (US 63609) (Hammond, E. Cuyler, and Daniel Horn, Smoking and Death Rates -- Report on Forty-four Months of Follow-up of 187,783 Men, JAMA, 2840-2857 (1958)); Brandt
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  1. These results were consistent with research being carried on outside the United States.

In 1957, the Medical Research Council of Great Britain issued a statement printed in the British

Medical Journal and the Lancet which read:

Evidence from many investigations in different countries indicates that a major part of the increase [in lung cancer] is associated with tobacco smoking, particularly in the form of cigarettes. In the opinion of the Council, the most reasonable interpretation of this evidence is that the relationship is one of direct cause and effect. The identification of several carcinogenic substances in tobacco smoke provides a rational basis for such a causal relationship.

01149261-9264 at 9264 (US 63537); Brandt WD, 75:23-76:12. However, at that point in time, the

Medical Research Council was not prepared to reach a categorical conclusion on causation.

  1. In January 1959, Jerome Cornfield, who was Assistant Chief of the Biometrics

Section at the National Cancer Institute and Chairman of the Department of Biostatistics at Johns

Hopkins University, offered a substantive review of the available evidence linking cigarettes to lung cancer. Cornfield and his colleagues carefully considered the range of alternative hypotheses to account for the significant rise in cases of, and deaths from, lung cancer. They concluded:

The magnitude of the excess lung-cancer risk among cigarette smokers is so great that the results can not be interpreted as arising from an indirect association of cigarette smoking with some other agent or characteristic, since this hypothetical agent would have to be at least as strongly associated with lung cancer as cigarette use; no such agent has been found or suggested. The consistency of all the epidemiologic and experimental evidence also supports the conclusion of a causal relationship with cigarette smoking, while there are serious inconsistencies in reconciling the evidence with other hypotheses which have been advanced. Unquestionably there are areas where more research is necessary, and, of course, no single cause accounts for all lung cancer. The information already available, however, is sufficient for planning and activating public health measures.

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This paper also explicitly refuted ongoing critiques by two well-known statisticians, Fisher and

Berkson:

We see nothing inherently contradictory or inconsistent in the suggestion that one agent can be responsible for more than one disease, nor are we lacking in precedents. The Great Fog of London in 1952 increased the death rate for a number of causes, particularly respiratory and coronary disease, but no one has given this as a reason for doubting the causal role of the Fog. Tobacco smoke, too, is a complex substance and consists of many different combustion products. It would be more "incredible" to find that these hundreds of chemical products all had the same effect than to find the contrary. A universe in which cause and effect always have a one-to-one correspondence with each other would be easier to understand, but it obviously is not the kind we inhabit.

VXA2510068-0098 at 0068, 0091 (US 63607) (Cornfield, Jerome, et al., Smoking and Lung Cancer:

Recent Evidence and Discussion of Some Questions, Journal of the National Cancer Institute,

22.1:173-203 (1959)); Brandt WD, 71:23-73:10.

  1. In 1960, the World Health Organization ("WHO") also issued a statement signaling its agreement with the Surgeon General's and Medical Research Council's conclusions. After conducting a review of the scientific findings, the WHO found a causal link to be the "most reasonable interpretation." Brandt WD, 77:22-78:1; Brandt TT, 9/27/04, 704:12-14.

  2. In 1962, yet another thorough and far-reaching assessment of the scientific evidence reached the same conclusions as previous studies. The British Royal College of Physicians, after two years of investigation, stated, "[d]iseases associated with smoking now cause so many deaths that they present one of the most challenging opportunities for preventive medicine today." The report concluded:

The strong statistical association between smoking, especially of cigarettes, and lung cancer is most simply explained on a causal

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basis. . . . The conclusion that smoking is an important cause of lung cancer implies that if the habit ceased, the death rate from lung cancer would eventually fall to a fraction, perhaps to one fifth or even, among men, to one tenth of the present level. Since the present annual number of deaths attributed to lung cancer before the age of retirement is some 12,000 . . . a large amount of premature shortening of life is at issue.

(no bates) (JD 001007); Brandt WD, 78:2-17.

  1. From 1953 to 1964, in articles, speeches, and testimony, the debate continued amongst many of the most respected scientists and organizations in the country:

1953: NCI's Director, Dr. John R. Heller, "testified that there has not been any conclusive proof that smoking causes cancer." Brandt TT, 9/28/04, 885:10-13. See also (no bates) (JD 004219 at 1018) (Department of Labor-Federal Security Agency Appropriations for 1954: Hearings Before the Subcomm. of the Comm. on Appropriations, 83rd Cong. 1018 (1953) (testimony of Dr. John Heller: "As you are well aware, the correlation of heavy cigarette smoking has been mentioned in connection with the occurrence of lung cancer, but this has not, to our satisfaction, definitely been established. . . .")).

1953: Three senior PHS scientists noted the statistical association, but stated "the etiological significance of these associations remains unestablished." (no bates) (JD 000720 at 1256) (D.A. Sadowsky, et al., The Statistical Association Between Smoking and Carcinoma of the Lung, JNCI, 13:1237-58 (Aug. 1952-June 1953)).

1954: Dr. Hueper, NCI's Chief of the Environmental Cancer Section stated that "causation had not been proven." Brandt TT, 9/27/04, 709:10-19.

1954: Surgeon General Scheele stated the "not proven" position and the clear need for "much more study." (no bates) (JD 020490 at DMA001 0629) ("Heavy cigarette smoking and the allegation that it causes lung cancer have received much attention lately. There appears to be a statistical correlation between heavy cigarette smoking and the occurrence of lung cancer, however, we do not believe that adequate evidence of a positive causal relationship has been proven. Much more study is required and is now in progress.").

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1954: Dr. Jesse Greenstein, Chief of NCI's Biochemistry Laboratory, wrote a biochemistry book which states: "At this time, the etiological significance of the apparent association of lung cancer and smoking remains unestablished." (no bates) (JD 000719 at 167) (Greenstein, J.P., Biochemistry of Cancer: Chapter III -- Extrinsic Factors (Academic Press 2nd ed.) (1954)).

1955: NCI's Chief of Environmental Cancer, Dr. Hueper, lectured that the value of statistical data was "at best circumstantial." (no bates) (JD 000467 at 67, 69) (Cigarettes, Laboratory Tests . . . The Industry . . . Medical Aspects, Consumer Reports, 20(2):56-73 (Feb. 1955) ("Dr. Hueper and some other experts regard the evidence linking lung cancer and cigarette smoking as insufficient or contradictory, and the theory generally as not proven. . . . [A]ccording to Dr. Hueper, a world-renowned authority on environmental carcinogens, 'the cigarette theory is almost entirely based on statistical data having at best circumstantial value and being in part of questionable origin.'")). See also (no bates) (JD 020522 at 173-74) (An Analysis of the Environmental Causes of Lung Cancer, American Pharmaceutical Manufacturers's Ass'n Proceedings of the Mid-Year Meeting at 149-178 (Dec. 6-8, 1954)).

1955: NCI's scientists reported to be "pretty well divided" on the possible causal relationship . (no bates) (JD 000711 at 8) (Edward R. Murrow, Cigarettes Lung Cancer, CBS television broadcast transcript, June 7, 1955). However, by 1957, NCI's Director, Dr. Heller "made it clear that 'only one or two' scientists in the NCI were not in agreement with the PHS [Public Health Service] view on the evidence." (no bates) (JD 004238 at 200).

1956: NCI's Director, Dr. Heller, testified before Congress that it was NCI's view that a cause and effect relationship between smoking and lung cancer had not yet been demonstrated. Brandt TT, 9/28/04, 886:3-9.

1957: Surgeon General Burney testified before Congress that final answers had not been secured, and, without "much more definitive information," a warning campaign should not be commenced. False and Misleading Advertising: Hearing Before the Legal & Mon. Aff. Subcommittee of the Committee on Government Operations, 85th Cong., 133-162 (1957). Surgeon General Burney went on:

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We believe that ["it is confirmed beyond a reasonable doubt that there is a high degree of statistical association between lung cancer and heavy and prolonged cigarette smoking"], and Dr. Heller's group agrees with that. . . . I would like to say again, however, that we do not believe the final answers have been secured and that there is a limit to what a responsible, official Federal agency can or should do before they have all available information. That is why I think we have stopped at a certain point. Using our particular judgment, and that until such time as we have much more definitive information, we should not go all out on a campaign and put stickers on cigarettes and certain other things.

Surgeon General Burney and Dr. Heller of the NCI testified about the agreement between scientists with respect to the role that smoking plays in lung cancer:

[T]here are many scientists in the Cancer Institute, and many differences of opinion, scientists being scientists. However, I would disagree . . . that there is a wide variation in attitude. Even a particular scientist who believes that air pollution is much more of a factor, for example, than smoking, says, however, that there is no doubt that smoking is incriminated in this process and it is simply a matter of degree. . . . I would say that the consensus in the Cancer Institute -- I can't speak for the entire Public Health Service, but certainly in the Cancer Institute and in the National Institutes of Health -- the consensus is reflected in the statement which the Surgeon General has promulgated. . . . An overwhelming majority [agree]. I would say with the exception of only 1 or 2 who do not agree completely with this viewpoint, but the overwhelming majority of the scientists in the National Institute of Health agree.

(no bates) (JD 11816 at 160). Dr. Heller further explained the agreement among scientists.

Taking the country as a whole . . . I would say the majority of them concur in this viewpoint. There are certain individuals . . . who do not agree. . . . This is

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characteristic of science in general, where there is a difference of opinion on many subjects. However, when one analyzes it to the utmost, there is not as much difference as one might think on the surface. . . . My best guess is that 75 percent of the physicians or scientists who have knowledge and some competence in this area would concur with this formula.

Id. at 161.

1957: NCI's Director, John Heller, told Congress that "elucidat[ing] the basic mechanism involved" was of the greatest importance in the direction of research. (no bates) (JD 000332 at 145) (Advertising (Filter-Tip Cigarettes), Hearings Before a Subcomm. of the Committed. on Government Operations, House of Representatives, 85th Cong. 145 (1957)).

1960: Biometrics Branch Chief, Dr. Harold Dorn, co-reporter for WHO's Technical Report No. 192, "Epidemiology of Cancer of the Lung," stated that "epidemiological studies of a disease such as lung cancer identify general factors that affect the incidence of the disease. The identification of the specific agent responsible for the effect of a general factor (for example, cigarette smoking or air pollution) must usually be made by laboratory or experimental studies. The Study Group recommends that such studies be encouraged. . . . The Study Group also wished to call attention to the fact that existing knowledge of the etiology of lung cancer is already sufficiently well established to justify prophylactic action aimed at reducing exposure to known etiological factors." FED 100017175-7184 at 12-13 (JD 045987).

  1. As the debate continued, by the early 1960s, the overwhelming majority of the scientific and medical community had come to believe that smoking was causally linked to disease.

For example, in 1962, Dr. Lewis C. Robbins, of NCI, acknowledged that although science could not yet take an "authoritative position" on the issue of causation, the public health stakes were too great to wait for submission of the complex experimental proof required by traditional causation standards.

Instead, PHS would send its message to the public based on a less stringent "public health" viewpoint:

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While one may be unable to take an authoritative position concerning proof of a relationship between smoking and lung cancer, there is a public health viewpoint which is of the greatest importance: It appears that there may not be definitive studies concerning this relationship in our lifetime. . . . There comes a time when science can show a high degree of probability but cannot answer the final question: Should this be applied to people? It is here that the practice of preventative medicine must pick up and take the final step.

(no bates) (JD 020481 at 2).

  1. In sum, by the early 1960s, the view of the scientific community had reached the conclusion that the evidence supporting a causal relationship between smoking and lung cancer was sufficiently established and recognized -- albeit not to a scientific certainty -- that it was appropriate to warn the public of the dangers it faced.

b. Before 1964, Defendants Internally Recognized the Growing Evidence Demonstrating that Smoking Causes Significant Adverse Health Effects 594. Internal documents reveal that Defendants' knowledge of the potential harm caused

by smoking was markedly different from their public denials on the same subject. Defendants specifically recognized the validity of the growing body of scientific evidence that existed in the 1950s.

  1. At the same time that Defendants assured the public through their 1953 "Frank Statement" that "there is no proof that cigarette smoking is one of the causes [of cancer]," they documented a large number of known carcinogens contained in cigarette smoke. 86017454-7454 (US 21418).

  2. For example, a December 24, 1952 memorandum titled "Report of Progress -- Technical Research Department" contained a "Cancer" section, which noted: "The B&W lab has in the past made a partial isolation and identification of the aromatic hydrocarbon, benzopyrene, in both smoke and original tobacco from RALEIGH blend cigarettes." The report refers to benzopyrene as a "carcinogenic hydrocarbon." 65020084-0095 at 0092 (US 21388).

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  1. Beginning in 1954, the BAT Group's major research laboratory performed research into the carcinogenicity of cigarette smoke by conducting skin-painting experiments on mice. As noted at Section V(A)(5)(b)(¶671), infra, this research showed that when compounds in cigarette smoke were painted onto mouse skins, they caused cancerous tumors. 682621615-1617 at 1615 (US 54180).

  2. RJR recognized smoking as a cause of disease in mice as early as 1953. This knowledge is documented in a February 1953 Report drafted by Claude Teague, an RJR research scientist, titled "Survey of Cancer Research with Emphasis on Possible Carcinogens from Tobacco." It was clear to Teague that, "[s]ome workers have attempted to produce experimental cancers in test animals by application of tars obtained from tobacco, tobacco smoke, and other materials derived from tobacco." Teague further acknowledged: "On the basis of the information at hand, it would appear that polynuclear aromatic compounds occur in the pyrolytic products of tobacco. Bensyprene and 'N-bensyprene[sic], both carcinogens, were identified in the distillates. . . . Studies of clinical data tend to confirm the relationship between heavy and prolonged tobacco smoking and incidence of cancer of the lung." 501932947-2968 at 2952-2953, 2961, 2963 (US 21407).

  3. A 1959 RJR document written by Alan Rodgman, an RJR scientist, discusses a 1954 report of a "carcinogenic (cancer producing) polycyclic hydrocarbon, 3, 4-benzpyrene" and elaborates on RJR's in-house research which corroborated this finding:

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There is no evidence that any of these compounds will produce cancer in man. Nonetheless, there is a distinct possibility that these substances would have a carcinogenic effect on the human respiratory system. Medical experience has shown that man responds to various chemical substances in the same manner as experimental animals. It follows therefore that it would be better for the consumer if cigarette smoke were devoid of such compounds.

*** Some thirty-odd polycyclic hydrocarbons have since been similarly characterized in these laboratories. Of these, eight are carcinogenic to mouse epidermis.

500945942-5945 at 5942 (US 21249).

  1. RJR sought to remove some of the cancer-causing compounds at the same time it was publicly denying that the compounds even existed: "[H]aving confirmed and extended the early published findings on polycyclic hydrocarbons in cigarette smoke, we initiated a lengthy research program to develop methods to lessen the amounts of these potentially dangerous compounds in cigarette smoke." 500945942-5945 at 5943 (US 21249).

  2. Rodgman's later work corroborated his prior findings. In 1956, he wrote an extensive paper on "The Analysis of Cigarette Smoke Condensate." In it, Rodgman explained:

The research described in this report represents a concerted effort to determine whether or not the polycyclic aromatic hydrocarbons are present in cigarette smoke condensate. One of the major objections offered to previous investigations is that the identification of specific compounds solely on the basis of ultraviolet absorption studies is not definitive. Since the present research describes the actual isolation, identification and characterization of several polycyclic aromatic hydrocarbons including the highly carcinogenic 3, 4-benzpyrene, the major criticisms of past research are now nullified.

Rodgman further wrote of the studies undertaken using standard Camel cigarettes:

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In view of this data, it is logical to assume that the carcinogenic activity of cigarette smoke condensate is due to the presence of one or more carcinogenic polycyclic aromatic hydrocarbons.

Since it is now well-established that cigarette smoke does contain several polycyclic aromatic hydrocarbons, and considering the potential and actual carcinogenic activity of a number of these compounds, a method of either complete removal or almost complete removal of these compounds from cigarette smoke is required.

501008241-8293 at 8254, 8279, 8280 (US 20667).

  1. Rodgman's views were consistent with what visiting scientists from the United

Kingdom observed in 1958 about researchers working for Defendants. The three British scientists reported widespread acceptance among top officials and scientists in the United States tobacco industry, including those at TIRC, Liggett, Philip Morris, and American, that smoking causes disease. They further noted that there was virtual consensus among researchers within the industry that cigarettes played a role in the production of human cancers:

With one exception (H.S.N. Greene) the individuals whom we met believed that smoking causes lung cancer if by "causation" we mean any chain of events which leads finally to lung cancer and which involves smoking as an indispensable link. In the U.S.A. only Berkson, apparently, is now prepared to doubt the statistical evidence and his reasoning is nowhere thought to be sound.

In their [Liggett's] opinion T.I.R.C. has done little if anything constructive, the constantly re-iterated "not proven" statements in the face of mounting contrary evidence has thoroughly discredited T.I.R.C., and the S.A.B. of T.I.R.C. is supporting almost without exception projects which are not related directly to smoking and lung cancer. Liggetts [sic] felt that the problem was sufficiently serious to justify large-scale investment by the Company directly in experimental research on smoke and cancer, accepting privately that

285

a strong case against tobacco had been made out and avoiding any public comment until their own research had provided something concrete to offer.

The majority of individuals whom we met accepted that beyond all reasonable doubt cigarette smoke most probably acts as a direct though very weak carcinogen on the human lung. The opinion was given that in view of its chemical composition it would indeed be surprising if cigarette smoke were not carcinogenic. This undoubtedly represents the majority but by no means the unanimous opinion of scientists in U.S.A. These individuals advised us that although it is not possible to predict unambiguously the effect of any substance on man from its effect on experimental animals the generally successful use of animals in other fields as a model for man fully justifies their use in our problem.

TINY0003106-3116 at 3108, 3111, 3112 (US 21369) (emphasis in original); Brandt WD, 94:896:13; Brandt TT, 9/28/04, 820:6-20.

  1. In 1962, Rodgman offered his assessment of "the smoking and health problem":

Although the major part of the sales of this Company consists of cigarettes, what the Company sells is cigarette smoke. This Company, therefore, should be concerned with the physiological properties and composition of cigarette smoke. The benefits from such knowledge are obvious, particularly [sic] it anticipates possible governmental regulation. During the past two decades, cigarette smoke has been the target of a host of studies relating it to ill-health and particularly to lung cancer. The majority of these studies incriminate cigarette smoke from a health viewpoint.

Epidemiological data: The results of 34 different statistical studies show that cigarette smoking increases the risk of developing lung cancer. Many authorities believe the relationship to be one of cause- and-effect. . . . The statistical data from the smoking-health studies are almost universally accepted. After more than ten years, criticisms of the studies have been reduced to the dictum. A statistical study cannot prove a cause-and-effect relationship between two factors.

286

Rodgman made explicit that he considered the evidence of smoking's harm convincing:

The Evidence to Date: Obviously, the amount of evidence accumulated to indict cigarette smoke as a health hazard is overwhelming. The evidence challenging this indictment is scant. Attempts to shift the blame to other factors, e.g., air pollutants, necessitates acceptance of data similar to those denied in the cigarette smoke case.

It has been repeatedly stated that some scientists discount the cigarette smoke-lung cancer theory. This is true. But it should be noted that many of those quoted in this regard are on record with contrasting views, e.g., Berkson, the statistician, has stated "...the definitive important finding of these statistical studies is not that there is an association between smoking and lung cancer, but that there is an association between smoking and deaths from all causes generally. . . ."

504822847-2852 at 2847-2848, 2850-2852 (US 20735) (emphasis in original); Brandt WD, 96:1499:4.

  1. Despite these writings, in 1995, Dr. Rodgman stated under oath that, as of 1962, he disagreed that it was "more likely than not that cigarette smoking caused health problems. This explanation is in direct contradiction to the clear wording of his own documents, set forth above, written 40 years before his 1995 testimony. Moreover, Dr. Rodgman had a financial incentive to offer favorable testimony to RJR when he testified. He worked for RJR as a scientist from 1954 to

1987, rising to the level of R&D Director of Fundamental Research. Since his retirement from RJR in 1987, Rodgman has been retained as a paid smoking and health litigation consultant to Womble

Carlyle PLLC ("Womble"), earning as much as a total of $600,000. Rodgman PD, United States v. Philip Morris, 6/26/02, 23:20-32:8. At the same time that he was being paid as a consultant to

Womble, Rodgman also served as a fact witness for RJR in its defense of various smoking and health cases. Id. at 12:10-16, 27:1-32:8, 33:2-25, 37:1-41:12, 42:14-43:11. Dr. Rodgman's recantation of the extensive analysis and findings of his research of the late 1950s and 1960s is patently not credible.

287

  1. Lorillard also conducted research which pointed to cigarette smoking as a cause of cancer and other diseases. In the early 1960s, Lorillard conducted in-house experiments on animals that showed ciliastatic effects of tobacco smoke on the respiratory tract. The cilia are small hair-like structures in the lungs which help move particles out and keep the airways clean. Spears PD, Blue Cross/Blue Shield of New Jersey v. Philip Morris, 3/23/00, 144:4-22.

  2. Philip Morris also recognized the link between cigarette smoking and disease. A July 24, 1958 memorandum written by C. Mace, head of research for Philip Morris, admitted that Philip Morris was aware that smoking was linked to lung cancer. The memorandum stated that "the evidence . . . is building up that heavy cigarette smoking contributes to lung cancer either alone or in association with physical and physiological factors." 1000305086-5087 at 5086 (US 20090).

  3. Dr. Helmut Wakeham, a high-ranking Philip Morris scientist, wrote in a September 22, 1959 memorandum regarding nicotine:

One of the main reasons people smoke is to experience the physiological effects of nicotine on the human system. Nicotine, to the best of present knowledge, does not produce cancer. Hence, in theory one could achieve the major advantage of smoking without the hazard of cancer. But nicotine in tobacco smoke is present in the tar phase, and so far a reduction in tar by filtration or otherwise has been accompanied by a comparable reduction in nicotine.

288
  1. Liggett internally linked smoking and disease, and sought to reduce or remove hazardous constituents. In a memorandum dated March 15, 1961, Arthur D. Little, Inc., Liggett's outside research consultant, summarized the results of the work it performed for Liggett:
  1. There are biologically active materials present in cigarette tobacco. These are: a) cancer causing b) cancer promoting c) poisonous d) stimulating, pleasurable, and flavorful. 2. There is no reason why the poisonous group, CO, HCN, NO2, etc., cannot be reduced, even though they are not seen as a primary health hazard. Methods for removal are: a) filtration (treated carbon, etc.) b) treatment for removing precursors, CN elimination c) addition as a reactant (urea for NOs). 3. Cancer promoting materials, esters, phenols, amines, can possibly be reduced by some treatment, extraction, etc. 4. The cancer-causing materials apparently are in many substances that are pyrolyzed but seem to be associated with tobacco in greater concentration than for primarily cellulose.

These findings were marked "confidential." 2021382496-2498 at 2496 (US 20345).

  1. A Liggett working memorandum titled "Alternative Theories of Carcinogenesis," prepared on April 24, 1963, acknowledged a causal relationship between "the chemical properties of ingested tobacco smoke" and development of carcinoma that was suggested by Defendants' scientists. 2022969727-9728 (US 20368).
289

c. In the 1950s, Defendants Began Their Joint Campaign to Falsely Deny and Distort the Existence of a Link Between Cigarette Smoking and Disease, Even Though Their Internal Documents Recognized Its Existence

  1. Beginning in the 1950s, all Defendants, including TIRC, the Tobacco Institute and

TIRC's successor, The Council for Tobacco Research–U.S.A., Inc. ("CTR"), issued numerous false public statements designed to mislead the public about the connection between cigarette smoking and disease.

  1. A March 1954 public speech to the National Association of Tobacco Distributors by

George Weissman, a Vice President with Defendant Philip Morris, captured Defendants' public position that there was no link between smoking and disease:

For never in the history of American industry -- a history that not so incidentally had its origins in tobacco -- has one industry been under such attack as we are today, never has an industry's very existence been so dependent on its relations with the public.

Which brings me to another, and even more important current problem! -- the current medical propaganda being directed against the cigarette industry by a small number of doctors and a large number of magazines, and newspapers. As many, if not more, distinguished scientists have disputed the arbitrary statements of the few doctors. As many, if not more, distinguished researchers, have pointed out other factors such as air pollution rather than cigarette smoking. There are many scientists who question the statistics and even doubt the fact that there is a health question involved in cigarette smoking. Yet, who rated the headlines when the charges were made? Unfortunately, the cigarette industry. Where were the denials and counterclaims? You sometimes had to use a microscope to find them. . . . If we had any thought or knowledge that in any way we

290

were selling a product harmful to consumers, we would stop business tomorrow.

2022239339-9343 at 9339, 9341 (US 21766) (emphasis in original); Brandt WD, 49:23-50:10.

  1. On April 14, 1954, TIRC published "A Scientific Perspective on the Cigarette Controversy," which restated the Frank Statement's pronouncement that the Defendants had accepted "an interest in people's health as a basic responsibility, paramount to every other consideration in our business." A total of 205,000 copies were printed and sent to 176,800 doctors, general practitioners and specialists. It was also sent to the deans of medical and dental colleges. The book and an accompanying press release went to a press distribution of 15,000, including editors of daily and weekly newspapers, consumer magazines, veterans magazines, and medical and dental journals, news syndicate managers, business editors, editorial writers, science writers, radio and television commentators, news columnists, and Members of Congress. The Sunday New York Daily News (circulation 3,800,000) gave feature treatment to the booklet, devoting a major part of the page to comment and a cartoon. The story was also sent to some 1,400 radio stations. 1005039987-0008 at 9990 (US 20192); TLT0902954-2955 (US 88388).

  2. In a July 1, 1954 statement by TIRC, Defendants promised not only to conduct research on the relationship between smoking and disease, but also to make their findings known to the public. VXA2511193-1194 (US 63544).

  3. On October 13, 1954, in newspapers such as the New York Daily Mirror, Timothy Hartnett, Chairman of TIRC, was quoted as saying that "no clinical evidence has yet established tobacco to be the cause of human cancer." ATC2454770-4770 (US 87049).

291

  1. TIRC issued a July 15, 1957 press release titled "Scientist Comments on Benzypyrene Report," where it disputed the United States Surgeon General's report that benzypyrene had been identified in cigarette smoke, and stated that scientists had concluded that benzypyrene in cigarette smoke cannot be a cause of cancer in smokers. This public statement contradicted internal B&W research. 11313243-3244 (US 20280); 650200084-0095 (US 21388).

  2. The Tobacco Information Committee, a TIRC subcommittee, published the first in a series of Tobacco and Health newsletters in October 1957. The newsletters contained articles that disputed the relationship between smoking and disease, criticized research that supported such a relationship, and asserted that differing opinions existed regarding tobacco use and health. The newsletter was sent to the medical and scientific communities. It reached a circulation of 520,000 in 1962, with about 315,000 copies being sent to doctors, dentists, and medical schools. The admitted purpose of the publication was to rebut and discredit the charges against tobacco. TIMN123324-3327 (US 21282); 511018410-8413 (US 22459); TIMN0070640-0656 (US 21299); TIMN0070657-0674 (US 22983); TIMN0081443-1457 (US 21307).

  3. A December 16, 1957 press release from TIRC falsely stated that "[n]o substance has been found in tobacco smoke known to cause cancer in human beings." 500518708-8711 at 8708 (US 21834).

  4. With the rising popularity of filters, Defendants attempted to promote their new filtered cigarettes as safer, without explicitly admitting that their previous products caused health problems. They continued to insist that the rise of filter cigarettes merely reflected the nature of consumer demand. James P. Richards, President of the Tobacco Institute, explained on June 30, 1958:

292

The cigaret industry has not changed its mind. Our position was and is based on the fact that scientific evidence does not support the theory that there is anything in cigaret smoke known to cause human lung cancer. . . . [The Tobacco Institute] believes that the health of the people is more important than dividends for any industry.

TIMN0122775-2775 (US 21326).

  1. In a newspaper article published on November 19, 1958, Clarence Cook Little was quoted as saying that there was scant clear evidence that smoking caused lung cancer, that much more research was needed, and that TIRC would continue to provide funds for independent research in universities and hospitals until the final answers were obtained. 501860595-0595 (US 21233).

  2. In a December 27, 1958 public statement, Hartnett, still TIRC's Chairman, emphasized that links to smoking and disease remained undetermined and asserted that an increasing number of factors were being associated statistically with lung cancer. He cited occupational exposures, specific air pollutants, place of birth and residence, previous lung ailments, and nutrition, claiming that these factors and others were subjects of much scientific investigation. He said that:

at its formation in January 1954, the Tobacco Industry Research Committee stated its fundamental position: "We believe the products we make are not injurious to health." We are pledging aid and assistance to the research effort into all phases of tobacco use and health. That statement and pledge are reaffirmed today by the members of the Tobacco Industry Research Committee.

500518759-8761 at 8761 (US 20636); Brandt WD, 88:6-89:4.

  1. In another Tobacco and Heath newsletter, TIRC claimed:

Continuing scientific research lends support to the position that too many unknowns exist today concerning lung cancer to warrant conclusions placing a major causative role on cigarette smoking, according to the 1957 Report of the Scientific Director of the Tobacco Industry Research Committee.

293

The publication also declared:

Cigarette smoking is compatible with normal health, and even heavier-than-average cigarette smoking is compatible with better- than-average mortality rates, according to a scientific report presented before the Southern Medical Association.

MNAT00515648-5651 at 5648 (US 72185); Brandt WD, 84:10-85:2.

  1. On November 27, 1959, the Tobacco Institute issued a statement attacking the article written by Surgeon General Burney on the hazards of cigarette smoking. See ¶¶137, 624;

TIMN0110091-0091 (US 21319).

  1. Little issued the following statement one day after publication of Burney's 1959 evaluation:

Despite the recent research trends, the conclusions set forth in the Public Health Service review rely almost entirely on past reports that are no more conclusive today than when these reports were first published. Most of the points are not new but are familiar to the American public because they were first advanced some years ago in statistical studies that admittedly are not supported by experimental evidence.

503283464-3467 at 3465-3466 (US 22981); Brandt WD, 90:20-92:5.

  1. Hill and Knowlton, TIRC's public relations counsel, explained its strategy in anticipation of the Burney report:

Comment from TIRC for the press remains an effective way to meet anti-tobacco publicity efforts and emphasizes the multiple factors that should be considered. This, of course, is complemented with a continuing program of supplying information to give editors and writers a balanced perspective on questions of tobacco and health.

Published in the November 28 issue of the Journal of the American Medical Association, the article signed by the Surgeon General

294

presented a selection of published data about smoking as related to lung cancer. Anticipating the appearance of the Burney article and learning of its contents in advance of publication, it was possible to provide the press promptly with statements from Dr. C.C. Little, Mr. James P. Richards, president of The Tobacco Institute, and others. Press stories used the tobacco industry comment in covering the Surgeon General's article.

HT0145148-5150 at 5148 (US 21177); Brandt WD, 92:23-94:7.

  1. Internally, Defendants acknowledged that, as William Kloepfer, Vice President of

Public Relations for the Tobacco Institute wrote to Earle Clements, President of the Tobacco

Institute:

Our basic position in the cigarette controversy is subject to the charge, and may be subject to a finding, that we are making false or misleading statements to promote the sale of cigarettes.

TIMN0072354-2356 at 2354 (US 63576).

  1. But Defendants' campaign continued. On July 6, 1961, the Tobacco Institute issued a press release that quoted the Tobacco Institute President George Allen's comments on current health concerns regarding cigarette smoking: "The tobacco industry itself is more interested than anyone else in finding out and making public the true facts about tobacco and health." Allen further claimed that "research in recent years has produced findings that weaken rather than support the claim that smoking is a major contributor to lung cancer." TIMN0104428-4429 at 4428 (US 21762).

  2. George Allen, President of the Tobacco Institute, explained the Defendants' ongoing position in a radio interview:

ALLEN: . . . All the medical authorities as far as I know, or practically all of them, agree that nobody knows what causes cancer, and specifically lung cancer, and this is a matter that remains to be found by thorough and energetic scientific investigation.

295

ALLEN: . . .That study [from the Royal College of Physicians, 1962], while considered very strong in its accusations, charges regarding smoking, nevertheless that study itself said that the majority of people smoke without any harm to their system. So if you say, am I going to get lung cancer if I smoke, a lot of people get lung cancer who have never smoked in their lives. We had a recent case, in which 27 nuns had died of lung cancer, not all together, not in the same place, but among the statistics . . . who had never been near tobacco. So, certainly one would have to say that if you just ask the question flatly, if I smoke, will I get lung cancer, there are many, many cases and evidences -- cited statements to the fact that there is no proved cause and effect relationship between the two.

500062010-2018 at 2011, 2015-2016 (US 20619); Brandt WD, 114:6-115:7.

  1. On March 14, 1963, eleven months before the release of the 1964 Surgeon General's

Report, the Tobacco Institute issued a press release to the New York Times containing a statement by Allen:

Scientific opinions differ widely. Many scientists say that more must be learned before it will be known whether any of the factors now under study, including smoking, has a role in causation of diseases such as lung cancer, and, if so, whether that role is direct or indirect, primary or incidental. In the opinion of these scientists, singling out tobacco as a major factor is not warranted by scientific knowledge.

TIMN0131426-1426 (US 21336).

  1. On April 15, 1963, ten months before the release of the 1964 Surgeon General's

Report, Allen commented on a recent booklet issued by the American Cancer Society:

There is dispute among scientists as to the causes of lung cancer. Many differing opinions exist. . . .

The booklet does not purport to contribute new knowledge. It is our belief that the answers to questions about diseases such as lung cancer will come through the research laboratory, not through booklets or campaigns for or against smoking.

296

TIMN0118348-8349 at 8348 (US 21320).

  1. A June 1963 Tobacco Institute statement by Allen similarly claimed that there was "dispute among scientists as to the causes of lung cancer." Allen reported that since 1954 the tobacco manufacturers had supported grant-in-aid research through TIRC and had contributed more than $6 million in funds towards independent medical and scientific research. While the research programs were continuing, the press release claimed that research findings regarding underlying causes of cancer and cardiovascular diseases were to that date inconclusive. TIMN0104311-4312, at 4311 (US 21317).

  2. A July 9, 1963 press release reaffirmed the Tobacco Institute's public position to not accept any claims that smoking played a part in causation of human disease until further research provided facts to link smoking to certain health effects. The release quoted Allen:

With the numerous theories, statements, and resolutions that have been presented to the public, there is some danger of losing sight of what ought to be the basic objective of all who are concerned. That is, doing the needed research. We believe the answers will be found. And they will be found in the scientific laboratory, not through pronouncements either for or against tobacco.

TIMN0098597-8598 at 8598 (US 21270).

  1. In September 1963, the Tobacco Institute issued a publication titled "Tobacco and The Public Interest." It provided: "[t]here ought to be a respite from theories, resolutions and emotional statements for a time at least, so that scientists can objectively evaluate what is known and what is not known." He reaffirmed Defendants' purported commitment to research to find necessary facts:

That is what this industry has tried to do in the past, through the research program of the [TIRC]. And that is what we shall do in the

297

future, until enough facts are known to provide solutions to the health questions involved.

TIMN0104251-4256 at 4254, 4256 (US 21316).

  1. On October 11, 1963, in order to intensify Defendants' public relations campaign in anticipation of the 1964 Report, the Tobacco Institute issued a press release: "Allen Outlines Some of Reasons Why Smoking-Health Theory is Disputed." It provided:

[P]eople sometimes forget that there are good reasons why the theories about smoking and health problems are in dispute, and are often questioned by responsible scientists. . . . [T]he original theory about smoking and lung cancer -- the theory that smoke was a direct, contact carcinogen -- has virtually been abandoned.

He asserted that the case against smoking rested largely on statistical studies, whose meanings were questioned by many leading medical statisticians, and that there was a growing interest among scientists studying the issue as to the possible role of constitutional and genetic factors. TIMN0118249-8250 at 8249 (US 21561).

  1. On November 3, 1963, a Tobacco Institute news release titled "Tobacco Industry Confident Research Will Find Answers, George Allen Says," stated that Allen was "convinced that scientific research will discover the answers to questions about smoking and health and the causes of the diseases with which smoking has been associated." After cataloguing Defendants' positions on smoking and health, Allen "suggested a moratorium on resolutions and emotional statements about smoking and health, so that scientists can objectively evaluate what is known and what is not known." TIMN0118245-8246 at 8245, 8246 (US 77055).

  2. The Surgeon General's Report was released on January 11, 1964. Following the release of the Report, Defendants continued to assert alternative causation theories. Despite overwhelming evidence from a wide range of disciplines including statistics and epidemiology, pathology and chemistry, clinical observation, and animal experimentation, as well as their own internal research, Defendants continued to claim "no proof" and continued to attempt to create doubt about the scientific findings.

298

  1. Defendants recognized -- and used -- the denial and rationalization used by smokers. In a memo to Joseph F. Cullman of Philip Morris, George Weissman, Executive Vice President Overseas (International), described how, in response to the 1964 Surgeon General's Report, "we must in the near future provide some answers which will give smokers a psychological crutch and a self-rationale to continue smoking." Among the "crutches" and "rationales" proposed to be offered to the smokers were questions of medical causation, "that more research is needed," and that there are "contradictions" and "discrepancies." 1005038559-8561 at 8559-8560 (US 20189).

  2. In testimony on June 25, 1964, five and a half months after issuance of the 1964 Surgeon General's Report, at a hearing of the Committee on Interstate and Foreign Commerce, Bowman Gray, Chairman of the Board of RJR, stated:

I believe . . . that nearly everyone familiar with these difficult problems would agree that there are large and basic areas where there is lack of knowledge, uncertainty, and where a great deal more research is essential before definitive answers can be made. Many distinguished scientists are of the opinion that it has not been established that smoking causes disease.

501935056-5071 at 5060 (US 20690).

  1. In a newspaper article dated July 12, 1964, Horace Kornegay, the Chairman and President of the Tobacco Institute, was quoted as saying: "There exists no definite proof that smoking cigarettes causes lung cancer or any other dreaded disease." TIMN013181-3181 (US 88779)3.
299

  1. On August 17, 1964, CTR issued a press release quoting Little: "The fact remains that knowledge is insufficient either to provide adequate proof of any hypothesis or to define the basic mechanisms of health and disease with which we are concerned." MNAT00287815-7818 at 7815 (US 21224).

  2. On December 29, 1965, the Tobacco Institute issued a press release reiterating that research had not established whether smoking causes disease and that it was still an "open question." The release went on to state that "[i]f there is something in tobacco that is causally related to cancer or any other disease, the industry wants to find out what it is, and the sooner the better." TIMN0123790-3793 at 3790, 3791 (US 21330).

  3. On October 21, 1966, more than two years after issuance of the 1964 Surgeon General's Report, the Tobacco Institute issued a public statement to newspapers that stated that the tobacco industry knew "of no valid scientific evidence demonstrating that either 'tar' or nicotine is responsible for any human illness." TIMN0099040-9041 at 9040 (US 21550).