TOBACCO Jones, Day, Reavis & Pogue Draft: Corporate Activity Project: Part 2
TOBACCO
Jones, Day, Reavis & Pogue Draft: Corporate Activity Project: Part 2
Bates # 681879254
Confidential
Attorney Work Product
Attorney-client Privileged
Jones, Day, Reavis & Pogue Draft
minutes of the meeting of CTR's board of directors on November 10, 1972 contains an ominous reference to 'a safe deposit box containing certain records of the Literature Retrieval Division, currently leased in the name of the Executive Vice President By the time of the Board of Directors' January 30, 1981 meeting, the mysterious safe-deposit
- box
- boxes
LRD was a division of CTR from 1971-1983, and continued to perform ;Its functon [sic] of analyzing, summarizing, indexing and retrieving scientific and medical literature at the direction of litigators. In 1983, LS, Inc. was created to be the successor of LRD.
5.
- Lawyer Involvement
Plaintiffs will argue that for at least thirty years, CTR's research efforts were held thrall by a closed circle of its lawyers. Not only did industry lawyers attend all meeting of CTR/TIRC and the SAB, but the same counsel represented the Tobacco Institute (and attended all its sessions as well),
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204 . CTR Minutes Of The Meeting Of The Board of Directors, November 10, 1972 (CTR 6463; 65008 1624; Gertenbach Duke/Rogers Exh. 11 DD). Tab 123.
205. CTR Minutes Of The Meeting Of The Board of Directors, January 30, 1981 (CTR 6584; 65008 1745; Gertenbach Duke/Rogers Exh. 11-VV) (emphasis added). Tab 124.
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demonstrating how diaphanous was the veil separating the Industry's research and lobbying bodies. Lawyer involvement raises potentially serious problems in three areas, (i) special projects; (ii) CNS research; and (iii) 'legal" review of grant applications.
a.
- Special Projects
Following victories in the early smoking and health litigation (including trials in
- Pritchard
- Lartique
- Green
The industry itself in need of developing witnesses to testify that (i) association is not equal to causation, and (ii) you can't extrapolate from animals to men. In reviewing CTR's research, it found no usable research to present to Congress. In addition, *Cigarette" research had become unpopular; journals refused to publish such; government funding dried up; and due to limited sources of funding, researchers turned their attention elsewhere, with the result that CTR's applications dried up.
Accordingly 'special projects, were born in early 1966, when, according to the minutes of a subsequent CTR meeting, "it was decided to undertake various special projects in the form of contract research, pilot and exploratory studies, short-term research projects and other projects--
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such as preparation of bibliographic reviews and analytical monographs "- whose character would render them narrower in scope than the broader objectives of the Advisory Board's grants-in-aid program."' More specifically, in 1965 or 1966, the industry directed its lawyers to get the needed data and witnesses, and Special Projects were born. In particular, Ed Cook of Davis, Polk went around lining up special projects.
Although special projects are given CTR's impramatur, they are not approved by the SAB."" In the words of Hugh Cullman (PM), one year's "special services and contingencies" were "for consultants such as Rosenblatt who are friendly to TIRC & SAB plus definitive experiments prior to granting grants. .208/ In addition, although the underlying purpose of special projects was to develop witnesses, special project grantees have "full freedom of publication," with attribution to CTR funding being required. Grantees have included Sterling, Fisher, Eysenck and Macdonald.
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206. Confidential Report CTR Meeting, January 27, 1967 (CTR 6420; 65008 1581). Tab 121.
207. The SAB minutes refer to special projects as 'applied research."
208 . Notes attached to Memorandum from Hugh Cullman to J.F. Cullman, 3rd, October 18, 1961 (1002607624). Tab 120.
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b.
- CNS Research
In the 1960s, the SAB was precluded from approving central nervous system ("CNS') research. The SAB was told by CTR's counsel, Ed Jacob, that such research had competitive significance. Moreover, given the close working relationship between the Scientific Director and the rotating chairmen of the Technical Advisory Committee, it was feared that one company might be able to appropriate such research before it became available to others. Indeed, Philip Morris was accused of appropriating Dr. Abood's CNS work by hiring him before completion of the work begun under a CTR grant. In addition, Dr. Sommers (in deposition preparation) explained that CNS research was terminated since it might be viewed as encouraging smoking, a personal practice that the SAB did not want to influence.
c.
- "Legal" Review of Grant Applications
Pursuant to standard procedure at CTR, an individual interested in a CTR grant is instructed to write a brief description of his proposal, the estimated budget and the amount of time necessary for completion of the research. - This proposal is called a case. If distributed to the members of the Executive Committee of the SAB for review and comment, it is assigned a case number. The Executive Committee of the SAB will then either encourage or discourage a formal application.
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The applications are reviewed semiannually and ranked according to priority, and funds are allocated accordingly.
During William Hoyt's 209/ presidency, cases were not automatically assigned a number. All potential cases went first to Hoyt for review. Proposals which were considered *dangerous" were sent "a Jacob, Medinger & Finnegan for a "legal" opinion.
Upon employment by CTR, Lorraine Pollice 210/ established a case log in order to keep better track of the proposals submitted by researchers."" There was no formalized system for logging in proposals prior to the creation of the log. Researchers tended to send their proposals to individuals on the SAB that they knew. The scientists (especially Dr. Hockett) would often keep a proposal on their desks for a lengthy period of time and the proposals often were lost. Thus, the log was started in an effort to keep centralized control over the grant proposals coming into the office.
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209. Hoyt worked for CTR from January 4, 1954 to March 1, 1984 and held the titles of executive secretary, executive director, executive vice president and president. Pollice did not recall the specific years Hoyt served as President.
210. Ms. Pollice is Assistant Treasurer and Secretary of CTR.
211. In 1981, Amy Minsky assumed responsibility for the log. She is no longer employed by CTR.
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The log had four columns: (1) the date received and the author's name, (2) the action taken by the Executive Committee, (3) legal opinion (subdivided into "To WTH" and "Rec. Opin." and (4) Letter Sent ("Encouraged" or "Discouraged"). The log entries indicate whether a legal mopinion was deemed necessary by Mr. Hoyt. Several entries note that a proposal was sent to Mr. Jacob (9597, #598). In the majority of cases in which it appears that a legal opinion was obtained, the proposal was eventually treated as a case. 212/ However, other files were apparently held indefinitely, not treated as a case, or a letter discouraging formal application was sent.
The proposals of greatest concern are the following:
1. Peter Bernfeld (no case #)
Bio-Research Consultants, Inc.
List Entry not listed
Log entry blank - no case number assigned
(p. 52)
Proposal date - February 2, 1983
Subject - Subchronic Inhalation Studies of
Tobacco Smoke in Inbred Syrian Hamsters
2. Don Cherek " (#565)
Louisiana State University Medical Center
List Entry (Hold - Legal) - Discouraged
4/24/79
Log Entry legal opin. rec: 'Yes, Deny per
WTH 4/23/79" (p.4)
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212. Pollice recalled that cases were periodically sent to Ed Jacob for review prior to being treated as cases. No record other than the log were kept of the case sent to him. She believes that Mr. Jacob would give his legal opinion to Mr. Hoyt by phone.
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Proposal Date - March 8, 1979 Subject " Investigation of possible anxiolytic actions of nicotine. Study of the effects of nicotine and diazepam administered in a punishment paradigm and in a progressive ratio.
3. Jack R. Cooper (#697)
Yale University School of Medicine
List Entry (Hold) per WTH
Log Entry legal opin: "Yes, hold per WTH
8/2/81" (p. 23).
Proposal Date - January 26, 1981
Subject - "Cholinergic Modulation of the Release of Acetylcholine from Myenteric Plexus Synaptomes." Using a nicotinic agent, possibly nicotine itself, to evoke ACh release, the study proposed to screen agents that had been observed in the intact ileum to modulate release of ACh.
4. Joseph Gal (#712)
University of Colorado Medical Center
List Entry (Hold) - Discouraged by Staff
4/22/81
Log Entry *Not distributed by Staff action, Hold per WTH 4/16" (p. 25) Proposal Date - April 7, 1981 Subject - Investigation of the metabolic fate of N-nitrosonornicotine.
5. A.W. Gustafson (#566)
Tufts University School of Medicine
List Entry Discouraged 4/16/79 - Exec.
Com. Mtg.
Log Entry Legal Opin: To WTH 3/14; Rec. Opin: 'Yes, O.K. to send WTH 3/16" (p. 4)
Proposal Date - March 7, 1979
Subject - "The Effect of Tobacco Smoke on Differentiated Form and Function of Tracheal Mucin-Producing Cells In Vivo and in Culture.'
Note: The Executive Committee reviewed the proposal and discouraged formal application on April 16, 1979.
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6. Richard Katz (#714)
Johns Hopkins University
List Entry (Hold)
Log Entry Legal Opin; "Hold per WTC 4/16"
(p. 25)
Proposal Date - April 10, 1981
Subject - Investigation of the effects of prenatal nicotine exposure upon development and subsequent adult behaviors in the rat.
7. Jennie Kline (#671) -
Columbia University
List Entry Discouraged 10/16/80
Log Entry Legal Opin: "Hold per WTH 9/24
(p. 19)
Proposal Date - September 4, 1980 Subject -
Study of the effects of maternal smoking on the human reproductive process, taking special account of the differences between brand and composition of the cigarettes that are smoked.
8. Marie McGee (4683)
Wake Forest University School of Medicine
List Entry - (Hold) per WTH
Log Entry - legal Opin: 'Hold per WTH
1/6/81" (p. 21)
Proposal Date - November 11, 1980
Subject - *Phagocytosis - Induced Injury of Activated Pulmonary Macrophages. Effect of Amosite and Chrysotile Asbestos."
9. Douglas McNair (#564)
Boston University School of Medicine
List Entry Discouraged 3/27/79
Log Entry Legal Opin: "O.K. to send per
WTH 3/16" (p. 4)
Proposal Date - March 1, 1979
Subject - Study of the effects of single cigarette smoking by moderate habitual smokers upon their performance of tasks of attention, and recent and long-term memory.
10. Arvind T. Modak (#597)
University of Texas
List Entry Legal Opin - Discouraged 8/13/79
Log Entry Legal Opin: To WTH: -Yes, per
WTH, sent Mr. E.J. 1/17/79" (p. 7)
Proposal Date - May 25, 1979
Subject - "Nicotine and the Central Nervous System.
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Note: See Exhibit C for copy of note in the file "from the desk of William V. Gardnerwhich states in part: "SCS (Sheldon Sommers) has stated he would like to see as much of this as possible go to Ex. Cmt. and SAB. I doubt this would pass E.J. at this time.'
11. Howard Shertzer (no case 0)
University of Cincinnati Medical Center -
List Entry not listed
Log entry -Discouraged by staff" (p. 55)
Proposal Date - May 10, 1983
Subject - "Identification of the Active Substances that are Generated from Indole-3-Carbinol and Which Protect Mammalian Tissue against Damage by Reactive Electrophiles.'
Note: File cover marked as follows: "Not Sent Out"
12. Cecilia Smith (#1034)
University of California
List Entry -Turned Down for Legal"
Log Entry *Turned Down for" (p. 70)
Proposal Date - April 23, 1984
Subject - Study to define the nature and sequence of the immunologic, cellular and histologic events in the lung which occur during inhalation of asbestos.
13. Richard Valachovic (no case 0)
Harvard School of Dental Medicine
List Entry not listed
Log Entry "Turned Down' (p. 49)
Proposal Date - October 12, 1982
Subject - Study of factors associated with human bone loss. Preliminary data suggested a relationship between certain smoking habits, bone loss and age.
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Ms. Pollice recalled that from the time- she began working for CTR in 1975 until Mr. Hoyt retired on March 1, 1984, cases were held for legal reasons. Mr. Hoyt was the only person who ever told her to hold a case for legal reasons. In the past, the scientists would have a staff meeting to review the proposals to ensure that all the requisite information (c.v. of the researchers, budget, etc.) had been submitted. Mr. Hoyt did not attend these meetings. Ms. Pollice made copies of the proposals which were deemed complete by the scientists and gave them to Mr. Hoyt. Mr. Hoyt would review the proposals and would instruct her to send out certain proposals as cases and not to send out others. She stated that the proposals which were not sent out would not necessarily have ever been entered in the log.
Ms. Pollice thought that Mr. Hoyt would be the only person who would know what cases were sent to Mr. Jacob for review. She stated that prior to the use of the log, if a case or proposal was held for legal reasons, there is no assurance that it could now be located. She briefly checked through a correspondence file in her office and found a letter from Mr.
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Hoyt to Mr. Jacob which roughly stated 'These four cases were approved by the SAS. Let me know what your reaction is." 213/
Finally, she emphasized that after Hoyt retired,"" proposals were automatically assigned a case number and sent out to the Executive Committee. She remembered that Amy Minsky asked her what to do with the log upon Hoyt's retirement and Ms. Pollice suggested that she discuss it with Gertenbach. She does not know the result of that discussion.
- Possible Industry Response: Corporate Responsiveness
- a. Individual Companies' Failure to Investigate
The rote response that the industry did not conduct smoking and health research inhouse is an invitation to disaster. It represents an unqualified admission that the manufacturers failed to discharge their nondelegable duty to adequately test their products. Proving these admissions will not compromise plaintiffs' ability to rely on damaging language
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213. When asked for a copy of the letter, she declined, saying she would feel more comfortable talking to the CTR's new lawyers about it first. In a previous discussion about the involvement of counsel, she indicated that the cases held for 'legal' which were sent to Mr. Jacob would generally be sent with a brief note such as "FYI" and would not indicate what the attachments were. Jacob would respond with a phone call rather than in writing.
214. Ms. Pollice recalled that Mr. Hoyt retired an March 1, 1984 and became a CTR consultant on that date. The case list indicates that cases were turned down for legal reasons as late as June 1984. See Exhibit D.
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in research documents, since such research by definition on (.i.e. , the industry's definition] was not smoking and health research.
A middle ground must be found. Perhaps the most appropriate one is that articulated by Dr. Colby: whether Reynolds conducted smoking and health research is a question of definition; under Dr. Colby's definition, for example, smoke constituent analysis is smoking and health research. I In addition to avoiding an unqualified admission, this approach (i) shifts the focus to the specifics of what in fact was done; (ii) avoids potential credibility problems between characterizing skin-painting work as smoking and health research when conducted by Wynder, but not when conducted by PM, Reynolds, or others, and (iii) opens the door for the industry to stress the major advances that have been achieved.
While a modification in approach is appropriate, the industry should not become overly defensive about its response to the smoking and health issue. No study or group of studies has ever established that cigarette smoking is necessary and sufficient to cause lung cancer. Indeed, the early retrospective studies maintained that causation could not be established by statistics and that other forms of data were
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required (but have never been found).'' 215/ Rather than develop such data, others have simply opted to change the rules of the game. The 1964 Surgeon General's Report acknowledges as much, and subsequent reports abandon scientific causation in favor of a "preventive medicinedefinition.
Furthermore, the industry did what it thought was reasonable . The companies monitored the literature, they formed R & D departments, they duplicated the tests, and yet neither the industry nor anyone else has ever been able to identify an appropriate animal model and no one has ever articulated a valid mechanism of carcinogenesis. Part of the industry research looked for causation, part of it was aimed to the flaws in the outside studies, and part of it looked for causes and cures of cancer, generally. Part of it attempted to determine if isolating and removed alleged harmful constituents would change the results of the skin painting tests. Some of it raised new questions. The industry position should be (and is) that it does not know if anyone will find the answer. None
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215. With respect to skin-painting studies, it is beyond dispute that Wynder's first mouse skin-painting study had exaggerated results (which were overly publicized) as demonstrated by Wynder's 1958 mouse-skin painting study and the ADL study, and that skinpainting involves unrealistically high doses and is now generally regarded as scientifically unreliable.
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of the previous research has established causation or lack of causation.
Plaintiffs - and the Industry's critics, generally - have seized upon the discovery of BAP in smoke as a convenient shorthand indication of the Industry's awareness of the alleged health hazards and its failure to warm. Defendants can turn the BAP issue to their own advantage. They should change their response from one of quibbling about the presence of BAP and its effect on the backs of mice. The strategy should be to acknowledge that BAP is in smoke and that it is carcinogenic in exaggerated doses to mice skin. Dr. Colby provided the best strategic answer: Dr. Wynder said take out BAP and you solve the problem. Then Dr. Wynder removed BAP and obtained the same results on mice skin without it."" This answer also demonstrates a larger point: The issue of causation is
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216. Spears Depo. Exh. 1. Dr. Wynder conceded in 1957:
The benzpyrene content of the total tar as well as of the active fractions is far too low to account alone for the positive results. So far, no carcinogens have been identified in large enough quantity in tobacco tar or its fractions to account for the observed activity. while a summation effect on several substances remains a possibility, it is more likely that carcinogens not get identified may be the most important ones in tobacco tar.
Wynder, E.L., Cancer, 'A Study of Tobacco Carcinogenesis" 1957). See Tab 93.
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complex . Furthermore, if consumers were aware that something in smoke caused cancer on the backs of mice, is it likely any smoker would behave differently knowing it was something called benzo[a]pyrene? Once BAP and other constituents became well known, did plaintiffs change their smoking behavior? Thus, ultimately, BAP appears a moot issue from a substantive standpoint.
In 1982, the Head of the American Council on Science and Health sent Horace Kornegay a letter asking for him what evidence would convince the industry that its product was ha harmful. 1 . Kornegay, on the advice of counsel, did not provide a direct answer. William Kloepfer did prepare a "list" of conditions he believed had to be satisfied."" The brevity
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217. These conditions included:
1. Explanation of the lack of agreement in prior studies.
2. Discovery of the reason why most smokers did not become afflicted with disease statistically associated with smoking.
3. A description of the physiological mechanisms of the development of smoking-related illnesses.
4. An identification of the elements which. as found in smoke, can be shown to be toxic.
5. Persuasive research to account for the reported male/female differences in
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of the list and the fact that it was not developed until 1982 support the plaintiffs' contention that the industry did not take the first step to investigate the health allegations against smoking. This information is or probably will be available to plaintiffs.
Industry witness can expect to face similar questions an deposition. They must be prepared to respond effectively. The following are points which have been gleaned in part from the various criticisms expressed by the R&D witnesses. It was not developed with any pretension toward scientific validity.
(1) The study must evaluate whether certain animals have respiratory systems sufficiently similar to human respiratory systems to be valid test animals.
(2) The animal's metabolism must be similar to human beings.
(3) The animal's immune systems must be similar to human beings.
(4) The study must evaluate whether any of the animals identified in (1). (2) and (2) have a life span comparable to human beings.
(5) The study must develop and evaluate a method of causing or allowing the animals to inhale smoke in a manner and dose similar to the human smoking experience, as well as for accounting for the myriad of variations in the
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217. Footnote Continued From Previous Page smoking-related illness rates.
6. Research which shows the invalidity of alternative hypothesis such as hereditary and constitutional factors.
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human smoking experience, including age at which smoking begins, number of cigarettes smoked, amount of tar and nicotine, and frequency and depth of inhalation.
(6) The study must ensure that the method of inhalation is devoid of unnatural trauma and stress.
(7) The study must be conducted over a period of time that approximates the interval observed in the human experience for lung cancer to appear.
(8) The study must determine whether the cells from which the observation arises are similar to the cells in which cancer arises in human beings.
(9) The study must develop and account for the total effect of smoking, including the benefits from smoking which may have an anticarcinogenic effect or other health benefit, such as:
(a) Pleasure
(b) Taste
(c) "Satisfaction"
(d) Relaxation
(e) Lower body weight
(f) Ability to cope with stress
(g) Increased concentration
(h) Social interaction
(i) Oral gratification
(j) Avoidance of boredom
(10) The study must measure and evaluate related or unrelated alternative causes of lung cancer.
(11) Environmental factors, such as air pollution, must be accounted for.
(12) The phenomenon of some nonsmokers contracting lung cancer must be explained.
(13) The phenomenon that some smokers, even ones with very high time/dose relationships, do not develop lung cancer must be explained.
(14) Absolute causation (virus, bacteria) must be investigated and resolved.
(15) Variations in cancer rates according to certain geographical considerations must be explained.
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(16) Adequate control groups must be established and evaluated.
There are obviously many other factors which could probably be developed, but the industry must be able to say: 'This is what would resolve the controversy, it is extremely complex, we are working on it, but the proper study has not yet been done.- Dr. Spears' testimony appears to come closest to this approach. 218/
In addition, industry technical witnesses should be prepared to demonstrate the inadequacy of studies cited by Plaintiffs. This information can also be used to cross examine plaintiffs' experts to gain admissions that they do not have the answers to all the questions: these admissions can reinforce the industry's position in front of the jurors and will, perhaps, raise questions in their minds. In any case, it provides some credibility to the R & D representatives and to the industry.
b.
- TIRC/CTR's Failure to Investigate
Overall, the industry insistence that the CTR is "completely independent" must be toned down. TIRC was a committee of industry representatives, and CTR has both remained under the control of a board of directors consisting
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218. Spears I Depo. at 31-37, 277-83.
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of industry representatives, and been funded entirely by the tobacco companies. Emphasis should be placed on the facts that the SAB has funded over $140 million in grants to persons who conducted smoking and health research, and that grantees were given full freedom of publication. Industry witnesses must be prepared to acknowledge CTR was not "perfect," while maintaining that it was a good faith effort to respond to the smoking and health controversy. Undue (and unnecessary) emphasis on the claim that CTR was independent risks raising a "corporate misconduct" issue and a loss of credibility. The fairest characterization appears to be that CTR really does sponsor no-strings-attached research, which not infrequently produces discomforting results, but its basic staff remains supportive of the industry position. This characterization may be too generous. An alternative position might be that the tobacco industry is as entitled to fund research calculated to support its position as opponents of smoking are to seek evidence supporting their preconceptions.
To the extent that industry can gain such admissions from plaintiff's experts about the credibility of CTR funded research, it demonstrates corporate responsibility and adds support to the "Open question.' Furthermore, this stratagem might take the credibility issue away from plaintiffs by changing the focus from the funding process to some of the significant credible research that resulted.
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In addition, the industry must prepare to defend the activities of TIRC/CTR. Without a major effort in this area, the industry will not only lose an important defensive shield but will also find TIRC/CTR being used as a sword against it.
In general, the industry must find an appropriate spokeman/expert who is fully familiar with TIRC/CTR's activities. There is an important and valuable story which must be told to blunt plaintiffs' efforts to obscure the forest by looking at a few trees. Portions of that story are discussed below.
While TIRC/CTR certainly was flawed, on balance, there was genuine worth in its work and a fundamental seriousness of purpose in its motivation. TIRC/CTR perceived the need for a soundly-based research program to tackle the smoking and health question -- which proved vastly more intractable than anyone imagined in 1954 --and developed just such a program.
In a memorandum dated July 16, 1959, Dr. Little elaborated upon the "basic principles on and around which our work has been and is being planned.' According to Dr. Little, both lung cancer and cardiovascular disease are "extremely complex" in origin and "undoubtedly due to many causes," involving "at least" the fields of heredity, infection, nutrition, hormones, nervous strain or tension, and
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environmental factors-"" Dr. Little went on to list sixteen "new projects to be developed with the SAB's advice."
These included:
1. A carefully controlled experimental study of the relative effects of the pipe, cigar and cigarette tobacco smoke condensates following the general experimental methods already employed by other investigators but with more careful controls.
...
3. The extension of the interesting methods of bioassay developed by Dr. Stephano. Until fast, reliable and simple methods of assay are developed, the testing of suspect substances remains uncertain and unconvincing.
...
5. The possible influence of arsenic and other trace elements in tobacco . . . .
6. Tissue culture--the recent discovery . . . of a completely synthetic medium for growing mammalian cells opens a much more accurate and controllable avenue of attack on the problem of growing and observing human lung tissue outside of the body.
...
9. Start of smoking habit. Studies in this field should be reviewed and research started under our direction
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219. Memorandum from C.C. Little to T.V. Hartnett, July 16, 1959, attached to Minutes of SAB Meeting, September 12, 1959 (CTR 2760; 65008 1919; Gertenbach Duke/Rogers Exh. 12F-3). Tab 134.
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and subsidy to find out what
- kind of children smoke and why
10. Twin studies . . . .
. . .
13. A study of urban and rural cats and dogs
. . .
16. Statistical studies . . . 220/
In a memorandum to the SAB dated May 26, 1962, Dr. Little expanded the list of possible projects. 221/
(1)
- Early Efforts: Smoke Constituent Analysis and Bioassay Systems
In the first decade of TIRC's existence, smoking and health research was in its infancy. Beyond epidemiology, chemical and biological research were being pursued both within and without the industry.
Chemical analyses of smoke did not require TIRC support, since reliable and reproduceable results were being obtained through the employment of new technology by the industry and by outsiders including Dr. Wynder and the
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220. Id. See also, Report by the SAB to the TIRC, March 10, 1960, for a summary of the first six years of the SAB's work and a list of 22 projected areas of research (CTR 2783; 65008 1943). Tab 135.
221. Memorandum from C.C. Little to SAB, 'Consolidation of SAB Planning and Programming Suggestions," May 26, 1962 (CTR 2826; 65008 1986). Tab 136.
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Tennessee Eastman Company. It was, however, considered vital that smoke constituent analyses be made available to TIRC grantees. Accordingly, in 1956 the SAS obtained an agreement to obtain the results of "a large-scale project" of the Tennessee Eastman Company for the 'chemical analysis of cigarette smoke," offered to supply the results of its study to cigarette manufacturers and to TIRC. However, "[t]hey do not plan to publish these reports but the methods and findings described can be communicated without citation, for use by TIRC grantees to expedite their own work." 222/ This "confidential" Tennessee Eastman report was subsequently delivered to TIRC and placed in its files.223/
The situation was not the same with respect to biological research. The only available bioassay system was skin-painting, which was unacceptable from many perspectives. Among these were controllable problems associated with varying procedures for the preparation of cigarette smoke condensate (which could result in nonreproduceable results, noncomparable
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222. Tobacco Board Meeting, December 2-3, 1956 (CTR 2706; 65008, 1865; Gertenbach Duke/Rogers Exh. 12-C-4). Tab 131.
223. TIRC Confidential Report, SAS Meeting, March 9-10, 1957 (CTR 2713; 65008 1872; Gertenbach Duke/Rogers Exh. 12-0-1 at 1). Tab 132.
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results, and artifactual results). In recognition of this, in 1955 the SAB resolved that:
2. Routine tar production and availability from some source outside the company laboratories is necessary.
3. Continuing analytical study of tobacco tars and of the effects of variables in production conditions upon their composition and its chemical effects is desirable.""
At the next month's meeting, Drs. Cattell and Hockett reported on a visit by them to the Ecusta Paper Corporation (which also produced cigarette paper) to examine its facilities for producing and supplying tobacco tars. The SAB authorized them to enter into an agreement on its behalf with Ecusta for tar supplies. 225/ Subsequently, Ecusta served as a source of tobacco distillate for all TIRC grantees requiring that product. 226/ During a subsequent meeting, the SAB approved a
224 . TIRC Confidential Report, SAB Meeting, January 16-17, 1955 (CTR 2644; 65008 1803; Gertenbach Cipollone Exh. 12-B-1 at 3). Tab 125.
225. Id. at 3; TIRC Confidential Report, SAB Meeting, March 20-21 1955 (CTR 2654; 65008 1813, Gertenbach Duke/Rogers Exh. 12-8-3 at 3). Tab 128. The resulting agreement with Ecusta was approved at the SAB's next meeting.
226. Tobacco Board Meeting, May 15-16, 1955 (CTR 2659; 6SOO8 181.8; Gertenbach Duke/Rogers Exh. 12-B-4 at 3). Tab 129.
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document originally drafted by Ecusta for distribution to grantees receiving tar from Ecusta. 227/
The SAB also foresaw the necessity for devising and standardizing a bioassay system (inhalation) which avoided some of the noncontrollable problems with skin-painting. In the January 1955 meeting noted above, the SAB also resolved:
1. A description should be published in scientific literature of satisfactory smoking machines which would include specifications and define conditions that must be met. 228/
The SAB therefore called on the Industry Technical Committee to 'tender a report on smoking machine standard with a explanation as to the reasons for the standards
while it is not clear from available records, it appears that little information about smoking machine standards was available. The SAB subsequently found it necessary or appropriate to consult with ADL's Dr. Kensler about smoking machines, 229/ and to host a meeting 'composed of the
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227. Tobacco Board Meeting August 22-23, 1955 (CTR 2669; 65008 1828; Gertenbach Duke/Rogers Exh. 12-5-6) and attached (-DATA ON COMPOSITE CIGARETTE CONDENSATE") Tab 130.
228. TIRC Confidential Report, SAB Meeting, January 16-17, 1955 (CTR 2644; 65008 1803; Gertenbach Cipollone Exh. 12-B-1 at 3). Tab 125.
229. TIRC Confidential Report, SAB Meeting, August 22-23 1955 (CTR 2669; 65008 1828; Gertenbach Duke/Rogers Exh. 12-B-6). Tab 126.
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principal people interested in smoking machine techniques. . - "230/
- (2) Animal Inhalation Studies
Early in its existence, the SAB also approved grants for animal inhalation studies. At the time, these must have been viewed as high-risk-but-need-to-know studies by the industry.
In 1955,
- fifteen years
During its September 12-13, 1964 meeting, the SAB authorized Dr. Little to proceed with a four-year project which
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230. Id.
231. See TIRC Confidential Report, SAB Meeting, January 16-17, 1955 (CTR 2644; 65008 1803; Gertenbach Duke/Rogers Exh. 12-B-1) (approving and activating grant No. 25). Tab 133.
232. See Tab 132 at 2. The referenced study was one of TIRC's earliest projects.
- 166
he had announced the previous May, involving the application of whole smoke to experimental animals under the direction of Dr. Freddy Homburger. 232/ By this time, however, animal inhalation research had failed to substantiate the causation hypothesis. Critics cited both the small test populations and dismissed the negative result on the pretext that "animals aren't stupid enough to inhale."
Responding to these criticisms, at its May 20-21, 1967 session, the SAB "approved in principle the need for an enlarged smoking inhalation program, including smoking machine development, testing and animal experiments." 234/ The SAB also requested the Industry Technical Committee to assist it in the development of a smoking machine for inhalation research and to suggest procedures for determining the extent of smoke exposure. 235/
-------------
232. CTR Confidential Report, SAB Meeting, September 12-13, 1964 (CTR 2857; 65008 2817; Gertenbach Duke/Rogers Exh. 12-K-3). Tab 137.
234 . CTR Confidential Report, SAB Meeting, September 22-23, 1967 (CTR 2891; 65008 2852; Gertenbach Duke/Rogers Exh. 12-M-3), Tab 138; see also: CTR Confidential Report, SAB Meeting, March 2-3-4, 1968 (CTR 2900; 65008 2869; Gertenbach Duke/Rogers Exh. 12-N-1. at 4). Tab 139.
235. CTR Confidential Report, SAB Meeting May 25-26, 1968 (CTR 2905; 65008 2874; Gertenbach Duke/Rogers Exh. 12-N-2). Tab 140.
- 167 -
The industry (Reynolds, Philip Morris, and Brown Williamson) responded to that request by developing three prototype smoking machines,"" and the SAB directed that "several of each of the machines (be] made available at designated laboratories as soon as possible for biological testing." 237 31' The SAS shortly thereafter funded research at the Mason Research Institute to 'check smoking machines" and authorized the purchase of three smoking machines for that purpose. 238/ The scope of this project and its funding were increased at the SAB's next session.239' The SAB also investigated a smoking machine developed by Lorillard 240/ and
-------------
236. CTR Confidential Report, SAS Meeting, March 22-23, 1969 (CTR 2921; 6SO08 2890; Gertenbach Duke/Rogers Exh. 12-0-2, at 6). Tab 141.
237. CTR Confidential Report, SAS Meeting, May 16-18, 1969 (CTR 2926; 65008 2895; Gertenbach Duke/Rogers Exh. 12-0-2, at 6). Tab 142.
238. CTR Confidential Report, SAS Meeting, December 12-14, 1969 (CTR 2939; 65008 2908; Gertenbach Duke/Rogers Exh. 12-0-4, at 2). Tab 143.
239. CTR Confidential Report, SAS Meeting, May 16-17, 1970 (CTR 2949; 65008 2919; Gertenbach Duke/Rogers Exh. 12-P-2, at 4) ('cats, rats, guinea pigs and possibly dogs"). Tab 144.
240. CTR Confidential Report, SAS Meeting; January 15, 16, 1971 (CTR 2963; 65008 2933; Gertenbach Duke/Rogers Exh. 12-Q-1. at 9). Tab 145.
- 168-
subsequently ordered such a device. 241 At its December 10-12, 1971 meeting the SAB approved the award of an additional $60,000 grant to Mason for 'carrying out (1) calibrations and functional tests, (2) a balance study, and (3) further studies of lung deposition of smoke' as well as an "appropriation to defray the salary and expenses of Dr. Nystrom of R. J. Reynolds Tobacco Company for his participation in these studies in the amount of $7,000.00
The SAB approved negotiation of an agreement with the Oak Ridge Laboratory (Union Carbide) for testing of smoking machines (with special reference to the Walton and Lorillard models) at its September 15-17, 1972 meeting."" It later appropriated $37,450 to develop "a smoking machine prototype
-------------
241. CTR Confidential Report, SAB Meeting, May 7-8-9, 1971 (CTR 2972; 65008 2942; Gertenbach Duke/Rogers Exh. 12-Q-2, at 7), Tab 146; see generally, CTR Press Release, March 14, 1973 (CTR 3813, 65008 5492; Gertenbach Duke/Rogers Exh. 13). Tab 147.
242. CTR Confidential Report, SAB Meeting, December 10-11-12, 1971 (CTR 2987; 65008 2957; Gertenbach Duke/Rogers Exh. 12-Q-4, at 3). Tab 148.
243. CTR Confidential Report, SAB Meeting, September 15-17, 1972 (CTR 3003; 65008 2973; Gertenbach Duke/Rogers Exh. 12-R-3, at 4), Tab 149; see CTR "Memorandum Concerning Proposed Contract With Oak Ridge National Laboratory For Developing Methodology And Evaluating Smoking Devices For Use In Biological Experiments,* October 27, 1972 (1002608411). Tab 150.
- 169 -
that will produce a continuous stream of smoke for biological purposes." 244/
The lengthy effort of TIRC/CTR to develop suitable equipment to expose animal models to chronic cigarette whole, fresh smoke inhalation studies culminated in the largest project which CTR has funded to date: a nine-year long, S12-million series of mouse inhalation studies performed under contract by microbiological Associates, Inc., of Bethesda, Maryland.
CTR announced the inception of this project on April. 2, 1974, in a press release headed '
- MASSIVE CANCER STUDY USING MADE-TO-ORDER MICE
A massive cancer study, using mice that have been literally made to order, is under way to see whether human-type lung cancer can be induced regularly in the animals
The unique investigation will try to induce squamous lung cancer, the type reported found most often in cigarette smokers, repetitively and predictably in the animals by exposing them to various chemical substances
-------------
244. CTR Confidential Report, SAB Meeting, October 30-31, November 1, 1974 (CTR 3037; 65008 3007; Gertenbach Duke/Rogers Exh. 12-T-2, at 2). Tab 151.
245. CTR Press Release, "Massive Cancer Study Using made-To-Order Mice,* April 2, 1974 (CTR 381.9; 65008 5498; Gertenbach Duke/Rogers Exh. 13). Tab 152 .
- 170 -
The experimental animals, of contrasting strains, are the result of scientific design to meet the study's goals . . . . The highly inbred strains are essentially 'laboratory creations" that never existed as such in nature and are combinations of several elements of susceptibility. on November 9, 1984 CTR issued a press release announcing to the public the final outcome of this research: 246/
- Inhalation of the smoke did not produce any squamous cell lung cancer, a type often reported to be associated with smoking by humans
. . .
- More than 10,000 mice
- over 800,000 cigarettes
The study also found that mice in which lung cancers were first induced by a chemical 247/ did not get significantly increased lung cancers when later exposed to long-term cigarette smoke inhalation. 248/
-------------
246. CTR Press Release, 'Findings Published on Cigarette Smoke Inhalation Study With Mice,' November 9, 1984 (CTR 3881: I 65008 5563; Gertenbach Duke/Rogers Exh. 13). Tab 153.
247. The 'chemical" was induced lung cancer was BAP.
248. This phase of Microbiological's work was to determine whether, given a previous application of a known cancer-i
- nducing
- promoter
- 171 -
Further, all types of lung tumors identified occurred at about the same frequency in the smoke-exposed mice, in "sham" mice (animals treated identically but without smoke exposure) and in mice kept an the shelf as controls.
A foreword to the book by Dr. Sheldon C. Sommers, Scientific Director of the Council, said the project "represented a determined effort to develop a suitable animal model involving chronic cigarette smoke exposure of inbred mouse strains known to develop various histopathological types of lung carcinoma after intratracheal administration of pure chemical carcinogens."
Thus, the SAB has funded at least three animal inhalation studies, all of which yielded negative results.
(3)
- Other CTR Funded Projects
In addition to the foregoing, CTR has funded a vast number of additional studies. An analysis of these activities is beyond the scope of this report. There are, however, a few anecdotal comments which hold the potential for significant affirmative evidence:
€ Two CTR grantees have received Nobel prizes.
€ CTR funding once kept the Framingham study alive. This highly- regarded, prospective epidemiological study has yielded both favorable and unfavorable data, and no expert would quibble with its independence.
€ CTR funding initiated the Finnish Twin study, which has now been continued by the Finnish government.
€ Many (and perhaps most) of CTR's funded projects have been jointly funded by the National Institutes of Health, thus removing any doubt of independence.
- 172 -
€ CTR has funded more smoking and health research than all voluntary health organizations combined. Further, the small fraction of CTR's budget devoted to public relations compares very favorably to the American Cancer Society, which has a huge PR budget and funds very little research.
(4)
- LS Inc.
The transference of 3i's functions to CTR in 1971 will be viewed as destroying any claim that CTR is "independent" of the tobacco companies. III likely will also taint any claim of the independence of the SAB, since fine distinctions will be lost on the jury. Perhaps more importantly, the work product protection to which an automated litigation support system is normally entitled is at grave risk.
All possible effort should be taken to preserve LS, Inc.'s entitlement to workproduct protection. Contingency planning should also be made in the event that the protection is breached, so that alternative mechanisms are available.
2.
- AMA/ERF
Plaintiffs' Contentions
In late 1963, shortly before the first Surgeon General's Report was issued, the industry and AMA agreed to fund research concerning smoking and health. Plaintiffs will argue that this was intended to silence the AMA's voice in the smoking and health area, to obtain the AMA's support in opposing the Federal Cigarette Labeling and Advertising Act,
- 173 -
and to reassure the smoking public and mollify Congress that the AMA was studying the problem of smoking and health. 249
In fact, the AMA frittered away the money on worthless projects. The industry's scientific directors and others at the individual tobacco companies criticized the AMA research on the basis that "not more than 50 percent of the program was relevant to smoking,* with "only 2 percent . . . allotted to carcinogenesis." Moreover, approximately "one-half of the grant money has been allotted to the five universities with which the committee members are directly associated." These criticisms were not revealed to the public.
After a decade, the AMA terminated the AMA/ERF project, and stated that the relationship had "blackened' the AMA's image. The industry struck back, stridently criticizing the final report of the AMA/ERF in a press release.
- Supporting Testimony and Documentation
On December 4, 1963, shortly before the first Surgeon General's Report issued, the tobacco industry orchestrated a significant coup: it succeeded in buying off the American
-------------
249 . See 'Transcript Of Cigarette Litigation Lecture Given At The Middlesex County Trial Lawyers Association Meeting of Wednesday, May 30, 1984" delivered by Marc Edell at 11. Tab 5.
- 174 -
Medical Association (-AMA-) for most of the next decade. 250/ On that date, the AMA's House of Delegates approved a program of research by its Education and Research Foundation ('ERF") to probe beyond statistical evidence, to search for answers not now available to such questions as which diseases in man may be caused or induced by the use of tobacco." 251 The AMA/ERF program was to be financed entirely by the U.S. tobacco industry, pursuant to an agreement entered into in February 1964 2 252/ 2 The AMA was not slow in expressing its gratitude.
-------------
250. Dr. Alan Blum, a former editor of JAMA, characterized the industry's funding of the AMA/ERF project as "a grant to buy off the complacency, and more importantly, the silence of the AMA for 14 years.' C. Kenney, The Boston Globe Magazine, "The Antismoking Guerillas" (May 4, 1986). Tab 155.
251. See Report of the AMA Board of Trustees, Supp. Rep.: "Tobacco and Health,' undated (T 0022314). Tab 154.
252. As it had not done with TIRC/CTR, Liggett participated in the AMA/ERF project- At a 'special conference" held on February 4, 1964, Liggett's chief executives and scientists discussed whether to support the project. The minutes of that meeting record that Liggett's President, Mr. Toms, 'stated that he had a very strong feeling that Liggett and Myers should undertake to work with the industry on industry-wide basis and on the general problem of smoking health.
- He also expressed a fear that he would not like industry to come up with something significant in the general area of improved smoking products as far as health is concerned and for Liggett and Myers not to be part of this development.
- 175 -
On February 28, 1964 its Executive Vice President, Dr. Blasingame," 253/ wrote the FTC urging it not to require warning labels on cigarette packages:
With respect to cigarettes, cautionary labeling cannot be anticipated to serve the public interest with any particular degree of success.- The health hazards of excessive smoking have been well publicized for more than ten years and are common knowledge.
(T]he answer which will do the most to protect the public health lies not in labeling (which is likely to be ignored), but in research. The AMA House of Delegates stated this when it approved (the AMA/ERF] program. 2 254/ On September 5, 1967, the AMA issued a press release concerning the work of the AMA/ERF that began by posing the question "is smoking a psychological addiction with deadly overtones or more in the nature of a bad habit?"255/ Hill Knowlton distributed copies of the press release under cover of
-------------
253. Some years later, Reynolds' Vice President and General Counsel, in a letter to his counterpart at Brown & Williamson, referred to Dr. Blasingame as 'our old friend-. (Letter from H. H. Ramm, to Addison Yeaman, June 16, 1970 (1003040101; 65005 1867; Bowling Cipollone Exh. 32). Tab 156.
254. Letter from AMA to Federal Trade Commission, February 28, 1964 (1005037377). Tab 157.
255. AMA News Release, "Three-Year Program Stimulates Tobacco-Health Research,* September 5, 1967 (1003042795). Tab 158.
176 -
an "Information Memo andum" dated September 8, 19 67 255/ in which it took some comfort from the 'tone of the release (as] shown in the second paragraph: 'the best estimate of clinicians and scientists in the field is that cigarets are a health hazard. But they admit they don't have the scientific data yet to establish why and how.
By late 1971, even the AMA had had enough and withdrew from the project (or vice versa?). The AMA's executive vice president advised the Tobacco Institute that:
. . . . he regards the program as a great liability -- that from AMA's view
- it has only caused further blackening of AMA's image
1. He is most anxious to avoid any incident which will create displeasure with AMA among tobacco area Congressmen--he said AMA needs their support urgently.
2. "He is told that 85% of the ERF research with tobacco funds has been "useful basic research" but that through neglect by all concerned no effort has
-------------
256. Hill Knowlton Information Memorandum, 'AMA Release on AMA-ERF Tobacco Research Program," September 8, 1967 (1003042794). Tab 159.
- 177 -
really been made to impress anyone in or out of AMA with this." 257/
During the course of the AMA/ERF project, elements within the industry were quite critical over the direction in which it was headed, or, rather, was
- not
While we recognize that in spite of the very extensive studies which have been made in the past there may still be gaps in our knowledge of the pharmacology of nicotine which the AMA Committee might feel it desirable and necessary to close,
- we are wondering if this area of effort should receive as much attention as they are giving
-------------
257. Memorandum from William Kloepfer, Jr. to Horace R. Kornegay, "Report on Meeting at AMA re ERF tobacco program,' September 3, 1971 (10026071-54) (emphasis added). Tab 160.
258. Memorandum from R. P. Carpenter to Dr. H. Wakeham, "AMA Education and Research Foundation Fund-Tobacco and Health Committee," December 2, 1965 (1002905IB4 ) . Tab 161.
259 . Id. Two of the AMA/ERF committee members - Bing and Seevers - also served at various times on the TIRC/CTR's SAB.
- 178 -
- to it to the almost total exclusion of carcinogenesis which we thought was the major smoking and health problem
The AMA/ERF attempted to defend the direction of its research three years later, asserting that "(w]ithin the context of the large amount of Federal funds available at that time for all types of research and the level of support for work in carcinogenesis, (AMF/ERF] decided to concentrate its efforts on fundamental cardio-vascular, respiratory and psycho-pharmacological research.' 261/
A second Philip Morris document reports that industry scientists attending an AMA/ERF program in Scottsdale, Arizona on May 68, 1970 concluded that "not more than 50% of the program was relevant to smoking" and that 'little of scientific significance will emerge from this program in the foreseeable
-------------
260. Memorandum from H. Wakeham to R. P. Roper, "AMA Education and Research Foundation FundTobacco and Health Committee," December 9, 1965 (1002905182; PM 770 Set) . Tab 162.
261. Meeting of the Committee for Research on Tobacco and Health, Summary Minutes, January 30, 11068 (1002905282; PM 770 Set). Tab 163.
- 179 -
future." 262/ Liggett's Dr. Mold attended this same meeting and was equally critical. 263/
Certainly, the tobacco industry was displeased with the AMA/ERF's final report on the project, issued an May 27, 1977:
Valuable information has been obtained relating to distribution, metabolism, excretion and toxicity of nicotine absorbed by the human body via cigarette smoking.
- In the area of carcinogenesis, the Committee restricted the number of awards because cancer research was being generously financed by the National Institutes of Health and other agencies. Nevertheless, the demonstration of potent co-carcinogens in tobacco and the potential value of the measure of inducibility of aryl hydroxalase as a determinant of susceptibility to lung cancer represent some of the more significant contributions in this area
- The Committee believe; that the bulk of research sponsored by this_ project supports the contention that cigarette smoking plays an important role in
-------------
262. "Comments on AMA-ERF Program for Tobacco and Health From. the Research Directors of the Supporting Companies," undated (1002905156; PM 770 Set). Tab 164.
263. See, Memorandum from James D. Mold to W. W. Bates, Jr., "AMA-ERF Program of Research on Tobacco and Health," June 16, 1970 (RC 6021932; Bates Cipollone Exh. 25, Provost Cipollone Exh. 277). Tab 165. Alexander Spears of Lorillard was also critical of AMA/ERF ("the program dealt largely with acute effects of nicotine and there were very, very few projects that were very relevant, had any relevancy really to smoke per se and cardiovascular disease.") (Spears Cipollone 315).
- 180 -
- the development of chronic obstructive pulmonary diseases and constitutes a grave danger to individuals with preexisting diseases of the coronary arteries.
Testifying before the U.S. House of Representatives' Interstate and Foreign Committee's Subcommittee on Oversight and Investigations on October 5, 1978, CTR's Dr. Robert Hockett attempted - unconvincingly to distance the industry from the dire bottom-line conclusions of the AMA/ERF final report.
The Tobacco Institute also countered the final report of the AMA/ERF with a Press Release, August 7, 1978, in which it quoted Mr. Kornegay as having said that "[t]he only real news in the AMA document is the contrived timing of its release to coincide with and discredit President Carter's trip to visit tobacco growers in North Carolina." 265
-------------
264. "Tobacco and Health," (Dye Exh. 2, Horrigan Dewey Exh. 3) (emphasis added). Tab 166.
265. (Illegible exhibit number; 003789). Tat 167.
- 181 -
- Possible Industry Response to AMA/ERF Studies
The industry should not accept the unfounded charge that AMA/ERF was an effort to buy AMA silence. In the first place, the charge directly challenges the integrity of the AMA, a proposition which will be difficult to sell. Second, it's not true, as evidenced by the fact that in June 1964, the AMA officially stated at- its annual convention that 'The American Medical Association is on record and does recognize a significant relationship between cigarette smoking and the incidence of lung cancer and certain other diseases, and that cigarette smoking is a serious health hazard.
The industry should further respond to criticism of the AMA/ERF in the same way it does to criticism of TIRC. The industry realizes the AMA/ERF research grants were not the perfect solution, but they were an attempt to try to resolve some of the health questions related to smoking. The industry should not attempt to deny or hide the circumstances surrounding the termination of the AMA/ERF funding because plaintiffs have documents from TI which set forth the circumstances. The least damaging strategy is a matter-of-fact attitude.
- 182 -
- 3 - other Industry-Funded Research
- Plaintiffs' Contentions
While the industry has funded a small number of other "outside" research projects, it has done so only when it has received clear advance assurances of a 'favorable' outcome. In the most conspicuous such case, it funded the ardent, pro-tobacco research project of a man late., alleged to have acted improperly.
- Supporting Testimony and Documentation
The tobacco companies funded a modest amount of research outside the framework of TIRC/CTR. One such project was that of Dr. Gary L. Huber then of Harvard, who managed to ingratiate himself with the industry in one of his early letters soliciting funds with his view that "it is our impression that the number of people at potential risk from tobacco consumption is extremely small relative to the very large number of people who now smoke.""" Dr. Huber also spoke of the *zealous campaign' of the 'anti-tobacco forces' and stated that "I personally believe, that this is the area in which most of the anti-tobacco forces will be concentrated in
-------------
266. Letter from G. Huber to A. H. Galloway, May 4, 1972 (!002905316). Tat 168.
- 183 -
the near future and it therefore is of crucial importance to support good work along these lines as soon as possible. 267/
-------------
267. Id. See also, letter from Gary L. Huber to A. H. Galloway, July 7, 1972 ('anti-smoking zealots-) (1002905337). Tab 169. Dr. Huber appeared before the March 1, 1980 meeting of the Tobacco Institute's Board of Directors and made a 'presentation, a discussion titled 'A Controversy at a Crossroad', considered the present state of medical knowledge on matters relating to tobacco and health, including a number of matters inconsistent with various charges made against tobacco, the many unresolved questions and some of the area (sic.) requiring further research." The Tobacco Institute, Inc. Forty-Sixth Meeting Of The Board Of Directors, March 1, 1980 (No LIS number; Lorillard 770 Set; 04209209). Tab 170.
The following year, there appeared in the
- Tobacco Institute Newsletter
- GARY HUBER, M.D.
- investigation of Possible criminal charges
- misused Ky. Institute money, falsified research data, and received money from tobacco companies,
Huber told the newspaper he is being harassed and threatened and his reputation smeared by disgruntled former and current employees who want him fired.
Former Surgeon General
- Terry
- 184 -
Not surprisingly, therefore, Huber's research resulted in a ringing endorsement of smoking. As reported at the American College of Chest Physicians meeting of October 24-28, 1979:
"Does tobacco smoking impair alveolar macrophage function?- --
- Gary Huber
- On the contrary, he said, the smoke appears to make the cells more effective, producing, in effect, a "super macrophage.'
Philip Morris and others in the industry, including Reynolds, contributed funds to the Sloan-Kettering Institute. In 1964, James Bowling (PM) recommended continuation of the company's contribution, noting that:
Dr. Frank Horsfall, Jr., Director of Sloan-Kettering Institute, has publicly expressed his doubt that smoking is implicated in carcinoma causation.
- Dr. Horsfall's opinion
-------------
267. Footnote Continued From Previous Page
reputation has been tarnished by pro-tobacco comments.
(No LIS number; Lorillard 770 set; 03020219) (emphasis added). Tab 171.
268. Memorandum, L. Zahn to W. Hoyt, November 2, 1976 (50027 4086) (emphasis added). Tab 172.
- 185 -
cigarettes)
- has been beneficial
- he has tremendous influence.
The industry earlier was made keenly aware of Sloan-Kettering's influence when SloanKettering researcher, Ernst Wynder, (Ph.D.) led the anti-cigarette attacks. He exploited his Sloan-Kettering association to the industry's distinct disadvantage. As an indication of the attention he received, TIME magazine featured Wynder's attacks on cigarettes -- with pictures -- on seven different occasions.
In the fall of 1962, Dr. Horsfall and other Sloan-Kettering officials including Public Relations Vice President Carl Cameron
- began subjecting Wynder to more rigorous screening procedure before letting him speak in the name of the Institute. This has had a proper and pleasing effect.
The industry also funded a project at the U.C.L.A. Medical School. As to one phase of this work, relating to lung macrophages and lymphocytes, the Medical School reassured the industry that nothing untoward was likely to turn up (i.e., the Gary Huber approach): "Although one cannot with certainty predict the outcome of such experiments, our preliminary results suggest that
- we are not likely to find any significant
-------------
-------------
269. Memorandum from James C. Bowling to C. F. Kibbee, November 23, 1964 (1005038364) (emphasis added). Tab 173.
- 186 -
- impairment of defense cell function in the smoker lung. On the contrary, smoker cells appear to be activated--. 270/
- Possible Industry Response to Other Research Projects
The least damaging response to the Huber and UCLA issues is a matter-of-fact attitude. The substance of the studies conducted by these researchers is favorable to the tobacco companies' position. Thus, unless the defendants give plaintiffs credibility issues by denying what they know about the outside studies, the issue marginally helps defendant.
-------------
270. Letter from M. Cline to D. Hardy, Esq., September 12, 1973 (010238) (emphasis added). Tab 174
- 187 -
- V . STRICT LIABILITY/NEGLIGENCE ISSUES
- A. The Risk/Benefit Test: Cigarettes Are Per Se Defective and Unreasonably Dangerous
- Plaintiffs' Contentions
Plaintiffs have contended that defendants are strictly liable in tort because the risks associated with cigarette smoking outweigh the benefits. Under their analysis, the first prong of the risk/benefit analysis asks whether the benefits or usefulness of a product outweigh the likelihood it will cause serious injury. Strict liability can be imposed without having to determine whether the product design could have been rendered safer.
- Besheda v. Johns-Manville Products Corp
Plaintiff may well contend at or before trial that the social utility of cigarettes is so far outweighed by their risk that the second prong of the analysis should never be considered that cigarettes should be
- 188 -
considered defective, as a matter of law. 252/
Marc Edell subsequently elaborated on this point as follows:
Q. Explain failure to warn!
A. That 's a pretty sophisticated question. There are two types of failure to warn cases, all right? There is a failure to warn case where you have a product that can be used safely. For instance, a solvent where if you read the container it says to use in a well-ventilated area. And there is nothing wrong with the solvent as long as you use it properly. Now as long as there is a warning on that product, the product is not defective. Then there is another kind of case. And that is a case where we have determined, that the product, despite that its got a risk that cannot be deleted from the product, is a product that has such social utility, such as pharmaceutical drugs, that despite that there are some risks in using it, a warning immunizes the manufacturer from any liability by providing the user with an
- informed consent
-------------
252. Plaintiff's Reply Brief on Motion in Limine to Strike Risk-Utility Evidence, Cipollone v. Liggett & Meyers Tobacco Co., et al., (D.N.J.) (filed December 9, 1985).
- 189 -
cannot use the warning as a shield to liability. 253/
At this presentation, Edell renewed his threat to seek partial summary judgment and/or a directed verdict on the issue of liability. He said, 'under certain conditions the judge may enter an order as a matter of law that the product is defective, and then you only decide whether or not the plaintiff contributed to his or her injuries by
- voluntarily smoking
- Supporting Testimony and Documentation
The 'risks" of smoking are well documented. We can expect. to see plaintiffs parading evidence that cigarette smoking causes 340,000 (or more) premature deaths per year in the United States alone, that morbidity is exceedingly high, and that the societal cost (in terms of medical care, lost work days, etc.) approaches $65 billion per year. Even without expert witnesses, plaintiffs may be able to adduce this evidence through governmental reports admitted under F.R.E. 803(8) or state equivalents.
-------------
253. Presentation of Mr. Edell to Oppenheimer & Co., January 16, 1986, at 16. Tab 3.
254. Id. at 3 (emphasis in original). Accord Plaintiff's Answers to Defendants' Contention Interrogatories in Cipollone. Tab 4.
- 190 -
The 'benefits" of smoking are far less well documented. In the 1964 Report of the Advisory Committee to the Surgeon General, the following helpful comment is made (at 356):
Medical perspective requires recognition of significant beneficial effects of smoking primarily in the area of mental health.
These benefits originate in a psychogenic search for contentment and are measurable only in terms of individual behavior. Since no means of quantitating these benefits is apparent, the Committee finds no basis for a judgment which would weight benefits versus hazards of smoking as it may apply to the general population.
Apart from this anecdotal comment, however, statements about the beneficial aspects of smoking are rarely, if ever, found in governmental reports.
Nor have the companies developed a fully satisfactory strategy for articulating the benefits of smoking. In New jersey, for example, Mr. Horrigan (Reynolds) testified that the benefits which smoking provides to its consumers is that "people who smoke find it pleasurable."? 5 255/ Mr. Heimann (American) identified only taste and pleasure."" Dr. Frank
-------------
255. Horrigan Dewey Depo. at 71; see Dey Depo. at 332.
256. Heimann Rogers Depo. 11 at 84.
- 191 -
G. Colby (Reynolds) was a little bolder in his response. He testified that even if it were proven that cigarette smoking causes cancer, he would not necessarily recommend a ban on cigarette sales because cigarettes allow people to cope with society's problems. They are "life savers" to some people. 257/
Plaintiffs will argue that a subjective benefit of "pleasure" cannot be accorded much, if any, weight in the risk/benefit analysis. Moreover, they will argue that the defendants' own documents belie this benefit. For example, they will cite a 1957 study conducted for Liggett which concluded that the vast majority of those interviewed wished they could stop smoking."" Similar documents can undoubtedly be found in every company's files.
On a personal level, the risk/benefit equation appears lopsided. It is perhaps for this reason that the Cipollone defendants have sought to expand the analysis to include societal concerns. Mr. Dey, for example, testified that the benefits which society derives from smoking include pleasure, tax revenue, a favorable impact on the balance of trade, and economic gain to farmers and retailers.259 Indeed, the
-------------
257. Colby Barnes Depo. at 177-78, 230-49.
253. Provost Depo. Ex. 28, at p. 15.
259. Dey Depo. all p. 31-2.
- 192 -
Cipollone defendants have broadly asserted that societal benefits must be considered, thus triggering plaintiff's motion in limine to exclude such evidence, which was recently granted by Judge Sarokin.
Beyond these matters, however, is one far more troubling. Specifically, several industry executives have made statements which could be construed as admissions that if smoking is found to cause disease, the benefits do not outweigh the risks. Given the predisposition of jurors to accept the causation hypothesis, these admissions may be damaging, indeed.
Mr. Judge, the President of Lorillard and former marketing executive for Reynolds, testified that if it were proven that cigarette smoking caused cancer, cigarettes should not be marketed, and he would quit . 2 260/ Gerald Long, the President of RJRT, stated in a recent interview:
If I saw or thought there were any evidence whatsoever that conclusively proved that, in some way, tobacco was harmful to people, and I believed it in my heart and soul, then I would get out of the business and 1 wouldn't be involved in it.""
-------------
260. Judge Depo. at 251-54, 261, 615.
261. Interview in Insight, "A Loyalist Views Tobacco's Fate(May 19, 1986). Tab 2.
- 193 -
James Bowling, an executive of Philip Morris, made a similar statement in deposition. 262/
- Possible Industry Response
Most witnesses said that they did not know what they would do if it were proven that cigarette smoking were proven to cause lung cancer because it was too speculative. The jury is likely to believe the witnesses are simply ducking a tough but important question.
The following response is suggested:
(1) IT has not been scientifically proven that cigarette smoking causes lung cancer Car any other disease];
(2) New scientific evidence may lead to the discovery of the cause;
(3) The new discoveries may identify something with which the industry can deal. [This is a delicate way of saying the industry can modify the product to remove the carcinogen];
(4) A lot of people derive benefits from smoking;
(5) The industry, the public, and smokers would have to evaluate the new evidence at the time it is discovered and make a decision;
(6) The short answer is: it is impossible to know what the industry, society or smokers would do.
-------------
262. Bowling Depo. at 535.
- 194 -
This answer is presumably the actual analysis that should occur. Second, it emphasizes the same "risk/benefit' analysis that each smoker is presumed to engage in. Third, and most importantly, it avoids conceding that the risks of cigarette smoking outweigh-the benefits.
In fact, this is the analysis engaged in by society through its elected representatives. In 1964, and three times thereafter, Congress considered all of the risks and all of the benefits and determined that the benefits outweighed the risks so long as smokers were formally warned of the risk. Even most of the severest critics of smoking do not favor prohibiting the sale of cigarettes. The defense must gain concessions from all. of plaintiffs' witnesses that they do not favor prohibition on the sale of cigarettes. Once it is clearly conceded that the industry is marketing a legal product, many of the socalled "risks" become much less significant.
- B. Design Defect: Cigarette Manufacturers Have Failed to Design and/or Market Safer Cigarettes.
- 1. Plaintiffs' Contentions
Under the second prong of the risk/benefit analysis, the jury must consider whether defendants could have reduced the risk to the greatest extent possible without hindering the basic utility of cigarettes. Besheda, 449 A.2d at 575; Feldman v. Lederle Laboratories, 478 A.2d 374, 386 (N.J. 1984); Dawson
- 195 -
v. Chrysler Corp., 630 F.2d 950, 957 (3d Cir. 1980) (applying New Jersey law). Thus, the issue is: Could the defendants, considering the state of the art (or all that was known to experts in the field), develop a cigarette which would be less dangerous to smokers without changing the product so much that it would not possess, or it would be too expensive to possess, the basic characteristics that smokers desire?
Plaintiffs have contended that the cigarette manufacturers knew or should have known of scientific data linking cigarettes and lung cancer during the 1930s or, at latest, the 1940S. In any event, the evidence is irrefutable that the companies were aware by 1954 of the early epidemiologic studies and the Wynder-Graham mouse skin-painting study. They will further contend both that the companies should have developed a "safer" cigarette through testing their products and taking steps to reduce the risk. In this connection, plaintiffs will focus on (i) Liggett's 'XA" selective filtration, palladium cigarette, and may focus on (ii) effective filtration, (iii) other means of selective reduction, (iv) low tar and nicotine cigarettes, and (v) tobacco/cigarette substitutes such as nicorette gum.
- Supportive Testimony and Documentation
In response to plaintiffs' contentions, the companies have broadly admitted that they did not attempt to manufacture
- 196 -
and market a 'safer' cigarette. The explanation given is that no cigarette has been found "unsafe' and, hence, it doesn't make sense to talk in terms of 'safer" cigarettes. Further, product modifications have generally been described as being developed in response to perceived or actual consumer demand.
While filtration and the development of low tar and nicotine cigarettes might properly be characterized as efforts to respond to consumer demand, the same is not necessarily true of efforts at selective filtration. It is unlikely that evidence can be adduced that consumers were clamoring for a product (like Lark) which selectively reduced ciliastats, or for a product (like the 'XA" cigarette) which selectively reduced PAHs.
Finally, there is a tension between asserting that low tar and nicotine cigarettes are not 'safer,' and the advertising campaigns for those products which explicitly or implicitly communicated the message that such cigarettes were "safe:."
- a. Specific Examples of "Safer' Cigarettes
Despite the disclaimers, the plaintiffs have adduced evidence that industry members have attempted to manufacture . safer" cigarettes. we can expect plaintiffs to point to one or more of these -- and, particularly, Liggett's XA cigarette -- as representing the state of the art with respect to cigarette design.
- 197 -
( i )
- Charcoal Filters
The work of Liggett and ADL leading to the development and commercial exploitation of the Lark charcoal filer grew out of the first phase of the two companies' joint study. According to what appears to be an internal Liggett memorandum explaining the medical basis for developing the Lark filter.
During 1957 (the Liggett/ADL) program was expanded to include a general study of the pharmacological effects of cigarette smoke and its components. In the succeeding years, this experimental program clearly demonstrated
- a number of undesirable effects arising from the presence of volatile and irritating vapors_ in the smoke stream. Many of these effects could be accounted for by the presence of hydrogen cyanide in small but detectable quantities in cigarette smoke. One of the primary and potentially most significant effects was the discovery that cigarette smoke, and its hydrogen cyanide component, inhibited, and in excessive quantities destroyed, the ciliary action of mammalian trachea.
In the wake of this discovery, according to the Liggett memorandum, "techniques for the accurate determination of the small quantities of hydrogen cyanide present in smoke were developed in our laboratoriesand 'techniques for measuring the inhibition caused by this and other smoke
-------------
263. 'Memorandum, Development of the Three Piece Keith Filter,- undated (Illegible Liggett production number; RC 6030441; Bates Depo. Ex',-.. 17) (emphasis added) . Tab 15.
- 198 -
components on rabbit trachea were also refined and more clearly established. This work confirmed the original discovery and led to the search for ways of reducing or eliminating the amount of hydrogen cyanide in cigarette smoke.'
In early 1962 Liggett's Director of Research, Dr. Darkis, requested his laboratory to search for 'a cigarette filter which would reduce the cyanide content of the smoke stream Later the same year "a chance event", in the form of laboratory tinkering, prompted Dr. Bates and the unnamed writer of the memorandum to hit upon 'the granular material contained in gas mask canisters" as "a possible solution to the problem.'"
With the help of a local volunteer-fire company . . . . several surplus military canisters were obtained and the charcoal-like granular absorbent was removed."" On April 18, 1962, filter cigarettes were prepared by hand [employing this material]. These
- cigarettes were found to be remarkably low in the amount of hydrogen cyanide leaving the filter during the smoking process. They also were found
-------------
264. Id.
265. Id.
266. NOTE: Ironically, Lorillard is also reported to have looked to world War 11 gas masks for a suitable filter material; as we know, it came upon asbestos rather than activated charcoal as the "miracle" ingredient. See Punitive Damages Issues, The Kent Micronite Filter, pp. _, infra.
- 199 -
- to provide a very Smooth, rather pleasant tasting smoke.
- these cigarettes did not inhibit ciliary action in our test system to any-where the extent found for ordinary cigarettes
Based upon this discovery, Liggett's Drs. Keith and Norman quickly developed a filter medium consisting of activated charcoal manufactured from bituminous coal impregnated with certain oxides and were able to manufacture it in production quantities early in January 1963." 268/ Thus was born the Lark charcoal-filter cigarette, first marketed by Liggett in 1963. 268/
Liggett's competitors quickly followed suit, and by late 1964, at least two additional brands incorporating charcoal filters had been introduced in the marketplace. 269/
(a)
- Health Claims for Charcoal Filters
Liggett certainly did not shrink from proclaiming the asserted health benefits of the Lark. On April 8, 1963, its Dan Provost wrote Dr. Kensler (ADL) enclosing "an outline of a
-------------
267. Id. (emphasis added).
268. Id.
269. Letter from W. Bates, Jr. to L. Thompson, October 15, 1964, enclosing report entitled 'NEW CHARCOAL FILTER CIGARETTES.' September 30, 1964 (illegible Liggett production number, 65005 2861). Tab 17. The two brands were American's Tareyton and Reynolds' Tempo.
- 200 -
long-range public relations program for Lark, including the important medical aspects of the program, which has been submitted to us by J. Walter Thompson." Mr. Provost also expressed to Dr. Kensler his view that 'it is important to lay a sound foundation now for the
- long-range medical public relations program
In fact, Liggett had already launched its "medical public relations program.- In a letter dated April 7, 1964 to the medical community, Dr. Darkis sought to capitalize upon the recent recently-released leased 1964 Surgeon General's report, which contained an obscure reference to the Liggett/ADL research (first made public in an article authored by ADL's Drs. Kensler and Battista) :
In the recent Report of the Surgeon General's Advisory Committee on Smoking and Health attention was drawn to the inhibitory effect of cigarette smoke on respiratory cilia. On page 34, the Report states: 'Components of the gas phase of cigarette smoke have been shown to produce various undesirable effects on test animals or organs . . . . One of these effects is suppression of ciliary transport activity, an important cleansing function in the trachea and bronchi
- The Report also notes that there is a cigarette filter containing special charcoal
-------------
270. Letter from Dan Provost to Dr. Charles J. Kensler. April 8, 1963 (No Liggett Production number: 65009 0856; Provost Depo. Exh. 3c) (emphasis added) . Tab 18.
- 201 -
- granules which reduces certain gases which inhibit the activity of mammalian respiratory cilia.
- has been reported that a filter containing special carbon granules removes gaseous constituents which depress chiliary activity.
- The reference cited is "New England Journal of medicine' (Kensler. C.J. and Battista, S.P.
- The specially treated charcoal-granule filter discussed in the Kensler and Battista paper was the prototype of the one which is now available to the public on Lark cigarettes. Since some of your patients may have heard of this filter through the lay press, and may inquire about its basis in science, we believe you may wish to have this information on hand.
While thus citing the Kensler/Battista publication, Liggett, in its message to the American medical community, conveniently did not advise its readership that the two ADL scientists had undertaken the work upon which they reported under contract with a cigarette maker -
- Liggett
In a draft of this letter, which it forwarded to ADL for its 'comments', Liggett alluded to its plan to present a paper concerning the Lark filter to the "54th annual meeting of
-------------
271. Letter from F.R. Darkis to "Dear Doctor," April 7, 1964 (65009 1314; Provost Depo. Exh. 33) (emphasis added). Tab 19.
- 202 -
the American Association for Cancer Research" (just in case its hardly-veiled health claim was not already plain enough.)' 71, Liggett wrote ADL on March 10, 1965, enclosing "a copy of a background sheet on Arthur D. Little Inc. for use in press kits overseas,' noting that "[t]his is essentially the same capsule summary of ADL which was widely used in our press kits in the United States in 1963 when Lark was introduced."273' Liggett also asked ADL to apprise it of "any newsbreaks" and stated that it was "not very happy about the leveling-off of the
- editorial noise
[W]e are working very closely with a free-lance writer . . . who is hard at work on a very comprehensive story on advance cigarette filters for ESQUIRE magazine.
- We have given him a vast amount of written materials, many suggestions, and perhaps some bad information
- with a positive attitude on tobacco and health
-------------
272. Letter from Liggett to Arthur 0. Little, March 8, 1963, (No Liggett production number; 65009 0857; Provost Depo. Exh. 4) (emphasis added). Tab 20.
273. Letter from Liggett to Arthur D. Little, March 10, 1965 (No Liggett production number; 65009 0883; Provost Depo. Exh. 14). Tab 21.
274. Id. (emphasis added).
275. Letter from Liggett to Arthur 0. Little, March 26, 1965 (No Liggett production number; 65009 0855; Provost Depo. Exh. 1) (emphasis added). Tat 22.
- 203 -
Liggett also referred, with enthusiasm, to the "Lark religion" displayed by the author of an article appearing in the "cover story for the SATURDAY EVENING POST" and notified ADL that (w] e are looking forward, with our fingers crossed, for favorable stories in the ELK'S MAGAZINE, in May and POPULAR MECHANICS in August." 276/
Later, in 1967, Liggett engaged in an extended exchange of correspondence with
- The Reader's Digest
(b)
- Challenges to the Efficacy of Charcoal Filters
Subsequently, there occurred an embarrassing (for Liggett) exchange of correspondence with Dr. George E.
-------------
276. Id.
277. E.g.: Letter from Liggett to The Reader's Digest, February 2, 1967 (Provost Depo. Exh. 10). Tab 23. Letter from The Reader's Digest to Liggett, February 16, 1967 (Provost Depo. Exh. 11). Tab 24. Letter from The Reader's Digest to Liggett, April 3, 1967 (Provost Depo. Exh. 12). Tab 25. and Letter from Liggett to The Reader's Digest, May 31, 1967 (65009 0879; Provost Depo. Exh. 13). Tab 26.
- 204 -
Moore 278/ of the Roswell Park Memorial Institute ("RPM!-) for which Liggett had only itself to blame. On May 31, 1967, the Director of its Research Department, Dr. Bates, wrote Dr. Moore
-------------
278. Dr. Moore was the author of a report issued on August 29, 1966 which was severely critical of certain filter-tip cigarettes and which concluded that "none [of the tested filters] is really protecting the smoker from possible lung cancer, emphysema, cardio-vascular difficulties, and other diseases.- Roswell Park Memorial Institute Press Release, August 29, 1966 (RC 6017613; 65005 2492). Tab 27. According to this report, *Pall Mall filter tip cigarettes appeared to be the worst of the eight brands tested" and that "[i]t is alarming to note that Pall Mall filter tip cigarettes pass more tar and nicotine to the smoker than do the regular Pall Malls without filters.' Id.
Dr. Moore also stated that:
These current results destroy the myth that all filters are helping to protect the smoker against the deadly effects of cigarette smoking.
Many filters are just not doing a job and until the cigarette industry accepts the responsibility of protecting their customers who refuse to stop smoking regardless of the health warnings, we will continue to see a staggering and unnecessary death rate due to cigarette smoking.
The tobacco industry apparently realizes that the public wants safer cigarettes. This is evident in the increase in filter tip cigarette production from 2 percent of the total cigarette output in 1952 to 64.7 percent in 1965.
Id. Hill and Knowlton circulated copies of Dr. Moore's press release to 'Company Public Relations Representatives," "General Counsel" and the "Ad Hoc Committee". Letter from Edward H. DeHart to Company Public Relations Representatives, August 29, 1966 (RC 6017612; 65005 2491). Tab 28.
- 205 -
("not . . . . to discuss the differences of opinion between you and the tobacco industry on your recent paper:
- Tar and Nicotine Retrieval From Fifty-Six Brands of Cigarettes . . . . ")
[Y]ou treat the "selective removal of gaseous constituents of the smoke' so lightly,
- in view of the demonstrated ciliastic, cytotoxic and macrophage depressant activity that has been associated biologically with many of the gas phase constituents which are selectively removed by effective charcoal filters . . . .
If these inhibitory effects are applicable at all to men, is it not to be expected that they would mediate the effects which you postulate are due to 'tar level? 279
RPMI dispatched two cutting replies to Dr. Bates's letter, challenging ADL's (Kensler's) professional integrity. In the first of these, dated June 3, 1967, Dr. Moore (RPM!) wrote Dr. Bates (Liggett):
A majority of the reprints enclosed by you involved work done by the group headed by Kensler. Personally I have grave reservations about their work since it represents a selective publication of research. In other words, their work is contract work performed for commercial
-------------
279. Letter from William Bates, Jr, to George E. Moore, May 31, 1967 (65009 0869; Provost Depo. Exh. 9 (lengthy citations to scientific papers - all authored by Liggett or ADL employees (authors* affiliations not disclosed to Dr. Moore] omitted) (emphasis added) . Tab 29.
- 206 -
- purposes and they publish only that information which they wish to release. For example, we are quite aware of the fact that they have confirmed the carcinogenicity of tobacco smoke but have not published this information
I have no objection to work performed from such laboratories but I think it should be clearly indicated in a footnote that it was done under contract.
. . .
- It is regrettable that much of this information is not available to us. In my opinion, those of us who feel that a safer cigarette can be designed are probably the ones most likely to help the tobacco industry in producing a safer product and thus not only protect the smoking public but also provide information which is actually in the interest of the industry. 280/
After Dr. Bates (Liggett) forwarded him a copy of Dr. Moore's (RPM!) letter, with the observation that "I am sure you will hardly refrain from commenting-, 281/ Dr. Kensler (ADL) took the bait, writing Dr. Moore:
It is obvious that you are ill informed on the nature of our programs here as well as on what we have published. You mentioned we are quite aware of the fact that they have confirmed the carcinogenicity of tobacco smoke but have not published this information".
- Your statement is false as
-------------
280. Letter from George E. Moore to William W. Bates, Jr., June 3, 1967 (ADL 7157 (attachment to ADL 7154)) (emphasis added). Tab 30.
281. Letter from William W. Bates Jr., to Charles J. Kensler, June 28, 1-967 (ADL 7154). Tab 31
- 207 -
- you can readily see by examining pages 11 through 17 of the enclosed reprint.
Dr. Moore replied to Dr. Kensler two days later:
- You are correct-that you did publish some experiments in a monograph which I overlooked. I do not believe that this work was done while you were on the staff of A.D. Little, Inc. I also believe that you have not published any data on the carcinogenicity of tobacco as independent research in a scientific journal since that time.
The record in these actions discloses no rejoinder by
Dr. Kensler to this letter:.
In its second response to Dr. Bates's May 31, 1967 letter, RPMI's Dr. Bock (a TIRC grantee) wrote him on June 9, 1967, proposing that the industry dare to challenge itself,
- in the laboratory
I gather that different investigators have widely divergent opinions on the relative importance of gas and particulate phase components as ciliastatic agents
- It seems to me that there is an experimental situation that one can be exploited to answer these objections at the present time.
-------------
282. Letter from Charles J. Kensler to George E. Moore, July 5, 1967, cc. to W. Bates (ADL 7153) (emphasis added). Tab 32.
283. Letter from George E. Moore to Charles J. Kensler, July 7, 1967 (no production number(s)) (emphasis added). Tab 33.
- 208 -
LARK, substantial numbers of smokers have used cigarettes containing appreciable amounts of charcoal. If I am not mistaken, Hammond has shown that "smoker's cough" is a sensitive indicator of a reduction in exposure to cigarette 'tar".
- A well-financed, long-term study
- might disclose whether reduction in tissue exposure results from consumption of charcoal filtered cigarettes.
- I understand full well that such a study would represent a radical departure in philosophy for most segments of the industry
- Every major manufacturing company has assembled a highly competent team to study the chemical nature of cigarette smoke and ways in which it can be modified.
- time has now come for a greatly increased examination of the clinical effects of changes in cigarette design.
. . .
- I would like to write again to ask for any suggestions that you might be able to offer us . 284/
-------------
284 . Letter from Fred G. Bock to William W. Bates Jr., June 9, 1967 (ADL 7159; Provost Depo. Exh. 9) (emphasis added). Tat 34.
- 209 -
The record in these suits contains no response by Liggett or ADL to this letter.
(c)
- Admissions That Charcoal Filters Were Not Safer
Sometime before May 24, 1973, Liggett received an inquiry from one of its advertising agencies concerning the mode of operation and efficacy of the Lark filter. To assist Dr. Mold in responding to this inquiry, his assistant, Vello Norman, prepared a memorandum covering various technical aspects of the Lark filter."" The Norman memorandum begins by noting that " [o]ver the years we have done a great deal of analytical monitoring of the performance of the (redacted! filter and that " [ t] he bulk of this work has been concerned with gas phase components which we consider to be physiologically most potent 'irritants' that are present in smoke in significant quantities, namely hydrogen cyanide and various aldehydes." After observing that Liggett had detected 59 compounds in the gas phase of smoke, Dr. Norman discussed
-------------
285. Memorandum from V. Norman to J.D. Mold, May 24, 1973 (RC 6029426; 65005 2927). Tab 35. We do not seem to have copies of either the advertising agency's letter to Liggett or Liggett's response. While Liggett's counsel have blacked-out the name of the brand whose filter is discussed in the Norman memorandum, they failed to remove one such reference (to Lark); that it was Lark, and not some other filter with which the memorandum dealt is also obvious from its content.
- 210 -
the ability of the Lark filter to remove them and concluded that 'one cannot make universally true blanket statements with respect to 'lightness' and filtration." Noting that the Lark charcoal filter "absorb(ed] gas constituents which are preponderantly heavier than air, [redacted] smoke should contain more nitrogen and more carbon dioxide (both heavier than air] than smoke from conventional cellulose actate (sic.] filtered cigarettes. The difference in the quantities involved, however, is so small that we cannot demonstrate it analytically
- and any statement that [redacted] smoke is 'lighter' than ordinary cigarette smoke would be based on very tenuous grounds."
Turning to the question of the 'potential harmful effect, if any," of the gas phase components, Dr. Norman opined that "[t]his is a complex and sometimes controversial subject . . . "
Work at Arthur D. Little (as well as by other investigators outside the sphere of Liggett and Myers' influence) has demonstrated that
- many constituents of the gas phase of cigarette smoke have detrimental physiological effects in animals
-------------
286. Id. (emphasis added).
- 211 -
When one considers the effects noted with pure chemicals in the light of the quantities that are actually present in smoke, the principal offenders would be hydrogen cyanide, acrolein, acetaldehyde and carbon monoxide . - - - [C]arbon monoxide is lighter than air and is not filtered out, hydrogen cyanide is lighter than air and is filtered out, and acrolein and acetaldehyde are heavier than air and are filtered out.
- Obviously, again one cannot make a generalization with respect to lightness and filtration efficiency for physiologically significant compounds.
Addressing the advertising agency inquiry about "solids" and their "potential harmful effects'. Dr. Norman was at a loss for words: "This is even a more controversial and complex subject than the gas phase and I shall not attempt to discuss it.' He added, however:
Suffice it to say that
- the particulate phase of cigarette smoke contains many compounds have been demonstrated to have detrimental physiological effects
- polycyclic aromatic hydrocarbons
With respect to these compounds, the
- Lark filtration efficiency approximately equals that of conventional cellulose acetate filters
-------------
287. Id. (emphasis added).
288. Id. (emphasis added). The word "Lark" was not redacted from the last-quoted sentence as it was elsewhere.
- 212 -
Thus, while Dr. Norman's memorandum may have been intended as warning to Liggett's advertising agency, Liggett certainly did not caution the users of Lark that its claim to "lightness" had no scientific basis beyond theoretical removal of relatively 'heavy". gas phase components based upon their
- molecular weights
- any
-------------
289. In another of Dr. Norman's memoranda to Dr. Mold, entitled "Very Efficient Selective Filters for Individual Smoke Components", he noted that the "two initial questions to be answered in this connection' are (1) "What kind of compounds can we selectively substantially eliminate from smoke' and (2) "Which of these compounds would be (sic)
- want
- commercial test
The desirability to filter out a smoke component selectively is largely predicated on
- negative medical connotations
- whether the compound is recognized as being detrimental by the consuming public.
To illustrate this point,
- if we were able to remove a large portion of carbon monoxide from smoke, the smoking public would surely recognize this as a substantial achievement. On the other hand, if we were to succeed in removing 99% of trans-2, 3-pentadiene the public probably could not care less.
(Emphasis added).
- 213 -
- Possible Industry Response - Charcoal Filters
Charcoal filters were marketed by Liggett (Lark), Reynolds (Tempo) and American (Tareyton). Lark and Tareyton are still on the market, and to the extent the plaintiffs contend or demonstrate that Charcoal filters are safer, they are available to plaintiffs and have been since Larks were introduced in 1963. The companies did not market charcoal cigarettes as "safer" because the Advertising Code and the FTC prohibited health claims.
Charcoal filters reduced the quantities of certain smoke constituents. Reynolds did not contend that reduction of these ingredients was significant from a health standpoint. Tempo, indeed, contained a health disclaimer. Thus, it is impossible to assert that Tempo made a health claim. Consumers were given a choice to smoke or not to smoke charcoal cigarettes. Very few chose charcoal filters. So few in fact. that Reynolds stopped all advertising for Tempo, and when its sales dwindled, Reynolds ceased marketing Tempo. Lark and Tareyton are still available to anyone who chooses to smoke charcoal filters.
- (ii) Low Gas cigarette - Fact
Fact, Brown and Williamson's 1976 entry into the "low gas" market, was developed as a cigarette that would selectively filter carbon monoxide. It was the subject of
- 214 -
discussion on the confidential portion of the 1981 FTC Staff Report. 290/ The Report noted that, following Fact's initial failure when introduced as a cigarette with the ability to filter certain gases, B&W had the Post-Keyes-Gardner agency devise a new campaign. A proposed strategy to distinguish Fact from its competitors would be emphasis on "More complete health protection through selective gas filtration." The agency attributed Fact's initial failure to the lack of public knowledge that gases might be harmful. It recognized that its new strategy
would mean expanding the cigarette health issue beyond tar to encompass gas. However, this would require establishing "gas' as a meaningful health hazard in cigarettes because currently there is very low consumer awareness or comprehension of the gas problem . . . However, if smokers are effectively educated regarding this problem, the selective gas filtration promise may still be powerful, particularly among the very health conscious. 291/
B&W found the implications of conceding the alleged ciliatoxic and cardiovascular ill-effects of smoking to be
-------------
290 . 1981 FTC Staff Report (TI 000463-466) (Kornegay Exh. 100).
291. 1981 FTC Staff Report at 2-22 (TI 000464) (quoting Marketing Advertising Strategy Recommendations for the Reintroduction of Fact Cigarettes, April 18, 1977).
- 215 -
.appalling.'"' it chose instead to wait "[u)ntil the problem of gas becomes public knowledge through government investigation or media coverage. 293 Little is known about Fact, but the plaintiffs could suggest that B&W deprived the smoking public of information about a safer cigarette in order to protect the allegedly more dangerous high CC cigarettes.
- (iii) Palladium Cigarettes: The Development of the 'XA" Cigarette
By 1968, ADL's work for Liggett entered a new phase: a determined, and costly, search for a non-carcinogenic cigarette. This project ultimately 'lasted more than twelve years. 294/ Liggett abandoned it, eventually, but only after it had come to a
- successful
- only
-------------
292. 1981 FTC Staff Report at 2-23 to 2-24 (TI 000465-66) (quoting Memorandum from G.T. Reid to F.E. McKeown, March 22, 1978).
293. 1981 FTC Staff Report at 2-23 (TI 000465) (quoting Fact 1977 Repositioning and 1978 Marketing Plan Summary).
294. The Lark filter, of course, had not been designed to alleviate the products* alleged carcinogenic properties. but only to lessen cigarette smoke's tendency to act as a ciliatory-inhibitor.
- 216 -
develop such a product. Second, the very fact of Liggett's project, when coupled with its cost (in excess of $15 million), belies its executives' routine denials of the link between cigarette smoking and cancer.
The Liggett/ADL "Safer" cigarette project wore several names during its lengthy course of development: "BIORES," "Project Tame," "XA-5001," and, finally, simply "XA." The project's guiding spirits were Drs. James Mold and Vello Norman of Liggett and Dr. Charles J. Kensler of ADL. During most of the project's history, Mold reported to Liggett's Director of Research, William W. Bates, Jr.
Not by happenstance, the Liggett/ADL project coincided, almost exactly, with the National Institute of Health's own 'safer' cigarette research project under the direction of Dr. Gio B. Gori. Indeed, Bates and Kensler each served, at one time or another, as members of the industry's Tobacco Working Group assigned to the NIH's study."" It is clear that Liggett's effort to develop a 'safer' product benefited considerably from the NIH's work, to which Liggett was privy; indeed, it represented Liggett's attempt to gain a
-------------
295. See NCI Report No. 4 'Toward Less Hazardous Cigarettes -The Fourth Set of Experimental Cigarettes,' March, 1980, at ix (Shook, Hardy & Bacon "Safer Cigarette Documents(not produced to plaintiffs]).
- 217 -
competitive advantage over others in the industry by being the first to market a product demonstrably "safe' according to the state of the art.
In an undated document, Liggett summarized the origins of its research efforts, beginning in the mid-1950s and culminating in its XA cigarette project:
In 1953, Wynder and his group reported that repeated applications of Cigarette smoke condensate could produce tumors on mouse skin. Shortly after this article was published, Liggett & Myers established a contractual arrangement with Arthur D. Little, Inc. The objectives of this joint effort were to determine the validity of Wynder's results when the appropriate smoking conditions were used, and to determine the effect of different types of tobacco on the response level. An extensive program was also directed toward defining the nature of the material responsible for the tumorigenic effort.
Wynder's findings were confirmed and all commercial cigarette types produced virtually identical mouse skin tumor incidences. The tumorigenic initiating effect was found to reside in a relatively small smoke fraction containing the polycyclic aromatic hydrocarbons.
In 1968, L&M initiated a tobacco additive program designed to reduce or eliminate the tumorigenic activity of cigarette smoke. Once the reduction in tumorigenicity was achieved, the next step involved the development of a commercially viable cigarette. The research efforts were then directed toward the compilation of evidence providing assurance that the
- 218 -
tobacco treatment would not introduce any new or increased hazard to the smoker. 296/
Iironically, the Liggett/ADL XA project was thus designed to develop a product able to satisfy the very bioassay test which Liggett and others in the industry have consistently derided:, mouse-painting. Liggett's $15-plus million project was designed, in short, to develop a cigarette capable of passing the test employed by Wynder, et al., from the beginning of the "controversy.- Thus, Liggett implicitly endorsed the validity of the assay-system which it and all of the other tobacco companies had invested millions of dollars toward discrediting in the scientific and public minds.
Documents in plaintiffs' possession, produced by Liggett and ADL, reveal the course of Liggett's project in considerable detail. In the end. Liggett and ADL, working together, concluded that Liggett had developed an experimental cigarette able to pass the mouse-painting test. Late in the project's course, one of Dr. Mold's assistants authored for him a 'Statement on What We Think that We have Accomplished on Project XA-5001":
Briefly, as a result of 20 years effort in cooperation with ADL, we have developed a
-------------
296. Liggett's summaries of the origins of research efforts, undated (RC 6029339; 65009 9319; Mold Depo. Ex". 31). Tab 37.
- 219 -
- cigarette system which Produces smoke of reduced biological activity. The activity referred to in this context relates skin of the mouse
- in accordance with protocols established by the-National Cancer Institute
. . .
- This year, for the second time, we hale seen one of our treated cigarettes give 80% fewer animals with tumors than the control tested alongside.
. . . Our experimental cigarette consists of a blend of commercial tobaccos
- treated with small amounts of two additives. One of these is a normal component of tobacco. especially ally burley tobacco, and the other is used extensively to purify automobile exhaust.
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297. Memorandum, 'Statement on What We Think that We have Accomplished on Project XA-5001," from A.G. Kallianos to J.D. Mold, July 28, 1977 (RC 6030238, 65009 9746; Mold Depo. Exh. 52) (emphasis added). Tab 38. This memorandum includes a particularly selfcongratulatory (self-serving?) observation: "In emphasis on current progress on this project, one should not lose sight of the fact that it is in very large part dependent on a far sighted management that has supported continuous research in this field for more than twenty years, at varying levels of manpower.
- 220 -
The "two additives" to which this memorandum referred were palladium (in one or another form) and nitrate. According to the materials produced by Liggett and ADL, the two substances, acting in tandem, dramatically reduced or eliminated the "biological activity" of test cigarettes in the mouse-painting studies.
In addition to the mouse-painting studies which it carried out using XA condensate, Liggett - at
- Dr. Wynder's suggestion
Beginning in 1975, Liggett applied for, and in time was granted, a series of U.S. and foreign patents for its XA process."" Even then, it was apparent to Liggett that something was amiss; Dr. Mold was informed by Liggett's patent attorney, Hendershot, that an examiner in the patent office had advised him that "Dr. Gori had been to the patent office trying to raise questions as to why our patent on this particular
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298. Mold Depo. at _____
299. Eg.: Liggett's U.S. and foreign patents marked as Mold Depo. Exh. 1, October 25, 1977; Exh. 4, August 12, 1980; and Exh. 6, February 3, 1981 (RC 6028406; 65009 8800; RC 6028419; 65009 8817; RC 6022431; 65009 8829). Tab 39. See Mold Depo. at 257-63.
- 221. -
development should be issued, which I thought rather strange. 300/
Liggett prepared to launch the product in the marketplace, hiring an advertising agency and a public relations firm for that purpose. 301/ According to Dr. Mold,
The advertising people came up with a number of proposed, just tentative advertising copy . . . . One I remember vividly was a sheet with a bunch of mice, some of them with tumors and some without on their backs, pictures of little mice.
Needless to say, that wasn't accepted, but there were a number of proposals . . .In another case, and probably as we got down the line toward as more refined kind of advertising copy, it was the kind of thing where you would see
- a page full of small print in which you start out with a disclaimer, and you end up with a disclaimer
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300. Mold Depo. at 358. See Mold Diary, Mold Depo. Exh. 15, for January 9, 1978 (65009 8392). Tab 40. In the diary Dr. Mold noted, 'a tobacco industry attorney has approached the patent examiner" suggesting a problem with the use of Palladium. The entry for February 7, 1978 identifies the 'industry attorney" as a "Brown & Williamson patent examiner.-).
301. Mold Depo. at 189.
302. Mold Depo. at 232 (emphasis added). See also, Advertisement Proposal by Dr. Mold, "Chemtech', May, 1978:
Nonsmokers are constantly amazed by the number of patents that this nuisance/vice generates. Here is one -- get this -- for a palladium-plated tobacco composition . . . . In order to suppress the appearance of polycyclic aromatic hydrocarbons "
- 222 -
Dr. Mold explained that Liggett believed that it faced an obstacle more formidable than devising advertising copy; the Federal Trade Commission. The problem was "how one might generate some interest in a cigarette like this without running afoul of the Federal Trade Commission's rule that you can't advertise health advantages." 302/
In an effort to deal with that concern, Liggett and its advisors did some high-level lobbying: On November 29, 1977, Dr. Mold and other Liggett representatives met at the white House with Charles O'Keefe, assistant to Peter Bourne, the President's health advisor. 304' The purpose of this
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302. Footnote Continued From Previous Page
prime carcinogen candidates palladium salts and a nitrate of another metal . are added to the tobacco leaf. These are applied in almost homeopathic quantities . . . and seem to function very effectively.
- The advertising surrounding the introduction of such a material should be quite something
(65009 8890; Mold Depo. Exh. 22) (emphasis added). Tab 41.
303 . Mold Depo. at 231. In a 1975 memorandum, Dr. Mold described a meeting with ADL concerning the XA project and wrote that "[i]n terms of the endorsement of this type of product, it was suggested that ADL might publish pertinent biological work and could perhaps organize a
- symposium
- with invited guests such as Wynder, etc. for
- the purpose of Publicity.
304. Mold Depo. at 237, 286; Mold Depo. Exh. 55. Tab 43 .
- 223 -
meeting was to
explain our problem of marketing such a cigarette as we had developed without being able to make any statements and advertising, that we had achieved some health benefits, because of the Federal Trade Commission's position on this type of thing. 305/
Dr. Mold elaborated that:
We had hoped that we might get some influence from the White House to perhaps have the Federal Trade Commission listen to our case a little more with the idea that they might bend their rules a little bit or something of this sort, in other words, to gel, some help from the White House to give us more leeway in advertising such a product with the Federal, Trade Commission.""
Upon being asked 'Did Mr. O'Keefe or Mr. Bourne take any action, to your knowledge, in connection with your effort to get the FTC to assist in this'" Dr. Mold testified that:
To my knowledge, the only effort that Mr. O'Keefe made was to
- contact the Tobacco Institute and tell them that we had come over there.
Asked 'Was that a surprise to you that he had done that?-, Dr. Mold testified:
No. Well, yes and no. I mean,
- many things like that had happened. but I guess I was a little surprised that they had
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305. Mold Depo. at 286.
306. Id.
- 224 -
- connections that close to the White House.
In January, 1979 Dr. Mold prepared a draft presentation to Liggett's board of directors in which he summarized the history and results of the Liggett/ADL project:
In 1953, Wynder, Graham and Croninger reported that cigarette smoke condensate was capable of producing tumors when applied repetitively to living tissue, namely the skin of mice.
- This finding has since been confirmed by numerous investigators.
- suggestive evidence from epidemiologic studies to involve cigarette smoke in the incidence of lung cancer.
Liggett 6 Myers Tobacco Co.
- immediately
- to determine the validity of the biological results and when this had been established to attempt to find the chemical nature of the components responsible and then to try to eliminate these materials from smoke. Our rationale was that it would be desirable to eliminate any such material whether there was a valid relationship or not between this biological result and human lung cancer, simply because whether we believed it or not, the fact was being used to indict cigarettes.
- Our endeavors in this area have been highly successful.
- polycyclic
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307. Mold Depo. at 287 (emphasis added). See Mold Diary, January 5, 1978 (65009 8392; Mold Depo. Exh. 15). Tab 44. Dr. Mold wrote, 'Greer advises me that Kornegay has become aware of our trip to see O'Keefe all the White House and wonders for what purpose. Joe told him re: patents, etc.'
- 225 -
- aromatic hydrocarbons
After evaluating several hundred materials as additives to tobacco in an attempt to decrease the yield of these polycyclic hydrocarbons,
- we found that we could best accomplish this by addition of small amounts of a palladium metal catalyst.