Why Was Research Stopped

Sensitivity. [CAVEAT: Significance is self-evident.]

According to DeNoble, "we were the only tobacco company that I knew of, or that anybody else knew of, doing work with whole animals, live whole animals, and because of the nature of the research, that is, looking at self-administration, looking at the effects of nicotine on the brain function, the research was held restricted to upper management only."

DeNoble discussed the effect of his research on the company with Dr. Charles, Dr. Osdene, Dr. Pages, Mr. McDow, Max Hausermann, Mr. Pollock, and Jim Remington. . . . "The downside was that we were

522

doing whole animal research, which looked to them like we were doing Federal Drug Administration [sic] research." DeNoble understood that the research he was doing could undermine the public posture Philip Morris was taking with outsiders. DeNoble discussed with Jim Charles and Tom Osdene the potential damage to the company of continuing animal research.

¶2046819241-9268 at 9256 -9257 (US 85265*) (citations omitted).

The 1994 Shook, Hardy & Bacon report also acknowledged the sudden DeNoble "Laboratory Shutdown," adding "[CAVEAT: Significance is self-evident.]." The report then acknowledges that DeNoble's research was suppressed: "[H]e was not allowed to publish the research regarding the effects of nicotine and acetaldehyde." This occurred "after a letter from Shook, Hardy to the Philip Morris Legal Department and discussions between [attorney] Alex Holtzman and [scientist] Jim Charles." 2046819241-9268 at 9258-961 (US 85265*).
None of the results or conclusions from the Philip Morris Nicotine Program or Behavioral Research Program were made public or were included in Philip Morris's and the industry's collective submission to the FDA in 1996. In fact, Volume III of the industry's "Comments" deny FDA assertions that research existed showing that nicotine is addictive. 2505597781-7998G (US 23028*).
Philip Morris was not only interested in suppressing research that suggested nicotine addiction, but consumer products that combated nicotine addiction as well. In 1984, Philip Morris became aware that one of its major suppliers of a humectant (a chemical added to tobacco to keep it moist), Merrell Dow Pharmaceuticals, was marketing a new smoking cessation gum called

523

¶Nicorette. Philip Morris understood the threat Nicorette posed, namely allowing nicotine-addicted smokers to quit, and took action:

Dow was told that we were discontinuing all humectant purchases because of Dow-Merrell's attack on cigarette smoking associated with the introduction of Nicorette, a nicotine-containing prescription chewing gum which reportedly aids patients in quitting smoking. . . .

Through a series of meetings over the past few years, Dow had been repeatedly advised of our displeasure over the anti-smoking nature of Dow-Merrell's Nicorette Program. . . . Dow was informed that the recent spate of activity can only be interpreted as a conscious corporate decision that Nicorette is more important than the Philip Morris (and other tobacco) business. That is, they cannot realistically expect a customer to spend millions of dollars for materials, when the profits from those sales, directly or indirectly, are used to attack that customer's product and perhaps reduce the customer's sales.

¶2023799799-9800 at 9799 (US 26801).

Philip Morris's representatives met with Merrell Dow on several occasions and attempted to shut down the marketing and sale of Nicorette. An October 25, 1984 Philip Morris document recorded the following threat at one of the Philip Morris/Dow meetings: "It was reiterated that Dow had been a superior supplier and that we desired to maintain our relationship. However, future purchases would be predicated on Dow's performance as a supplier as well as the course of the Nicorette program." 2023799801-9802 at 9802 (US 37048); Henningfield WD, 167:7-168:22.

¶See also 2023799804-9804 (US 26802); 2023799803-9803 (US 37049).

¶b. BATCo

BATCo's efforts to conceal the nicotine research it carried out at Battelle Labs dates back to at least 1963. In a May 29, 1963 letter to the Tobacco Research Council ("TRC"), the

¶English equivalent of CTR, Sir Charles Ellis enclosed several nicotine research reports, but stated that the BATCo Board "wish me to ask you that these reports should be kept strictly confidential" by the TRC executive committee. Ellis's letter is marked "STRICTLY PERSONAL AND CONFIDENTIAL." 105620759-0761 (US 85387).

524

In an October 25, 1978 memorandum titled "Notes on BAT/ITL Joint Meeting," Ed Jacob, a longtime tobacco industry counsel in the United States, advised that there be "a total embargo on all work associated with the pharmacology of nicotine and the benefits conferred by smoking for three reasons," including "a pending California lawsuit which indicted nicotine as an addictive substance," and another lawsuit "against [HHS Secretary] Califano to show cause why tobacco should not be brought under the powers of the FDA." 110083647-3650 at 3649-3650 (US 76174).
At a February 16, 1983 meeting of tobacco company directors, attended by Manny Bourlas of Philip Morris, L.C.F. Blackman, a BATCo board member and former head of research, and representatives from several European tobacco companies, the participants discussed how to respond to the impending Independent Scientific Committee on Smoking and Health ("ISC") Report. The participants agreed that the tobacco industry should not cooperate with the ISC and should respond to government requests by falsely stating that it had no relevant expertise. The participants agreed on the need to avoid any "sensitive" studies, including research into nicotine's role in "perpetuating the smoking habit":

The effect of nicotine at the levels achieved through smoking. While animal experiments could probably be designed to study the effect of nicotine (either by itself or as 'spiked' additions) our response to the ISC should be that we have nothing to offer. The little information we have is already in the public domain, and we have no idea as to a worthwhile research programme . . .

525

The role of nicotine, at the relevant lower range of nicotine dosage, in perpetuating the smoking habit. While much information already exists in the literature (Russell, Ashton and Stepney etc) this is a particularly sensitive area for the industry. If any future study showed that nicotine either was, or was not, associated with perpetuating the smoking habit, industry could well be called upon to reduce or eliminate nicotine from the product. (A heads we lose, tails we cannot win situation!) We must not become involved in any collaborative study with the ISC.

¶109840698-0702 at 0699-0700 (US 21733) (emphasis in original).

c. Brown & Williamson 1309. In 1963, as the following facts demonstrate, B&W, acting in concert with its parent

¶BATCo and RJR, concealed nicotine and addiction research from the Surgeon General's Advisory Committee, which was then in the process of preparing the Surgeon General's 1984 Report on smoking and health.

The 1959-1964 BATCo nicotine research, carried out under code names "MAD HATTER," "HIPPO," and "ARIEL," was provided to B&W. This was research that, in the words of BATCo's lead scientist Sir Charles Ellis, was designed to determine "what constitutes the hold of smoking, that is, to understand addiction." 301083820-3835 at 3826 (JE-46579). Ellis also acknowledged that the BATCo secret nicotine research gave the industry "knowledge of the effects of nicotine far more extensive than exists in published scientific literature." 301083820-3835 at 3828 (JE-46579).
Moreover, B&W executives were present at a 1962 BAT research conference where Ellis declared the group's position that "smoking is a habit of addiction." This copy of the conference report is stamped "Property of Brown & Williamson Research Department." 6503444331312. PROJECT HIPPO I was completed in January 1962, finding that rats developed tolerance to nicotine and that nicotine shared many similarities with tranquillizers. The final report on PROJECT HIPPO II, dated March 1963, concluded that nicotine had many more beneficial physiological effects than tranquillizers, benefits that support "the pleasure of smoking" and lead to withdrawal. 105620620-0683 (US 20247); 105620569-0605 (US 20246).

526

General Counsel Addison Yeaman, in a "STRICTLY PRIVATE AND CONFIDENTIAL" memorandum dated July 17, 1963, reviewing PROJECT HIPPO I and II, agreed that "nicotine is addictive" and that "we are in the business of selling nicotine, an addictive drug." Yeaman also advised that the company should develop filtered products that still delivered the necessary "nice jolt of nicotine." 682764441-4461 at 4455 (US 21030).
On May 14, 1963, B&W's President William S. Cutchins received a request for information from the Surgeon General's Advisory Committee regarding smoking and health matters. In a response to the Assistant Surgeon General James Hundley, Cutchins simply stated that B&W contributed to smoking and health research via its contributions to the TIRC. 680249780-9781 (US 85390); See also, 680249799-9799 (US 85389). No information about PROJECT HIPPO I or II was supplied.
Cutchins' letter was the carefully crafted product of industry legal advice. In a letter dated May 6, 1963, to B&W in-house counsel DeBaun Bryant, outside counsel J.M. Johnson recommended that the company respond to the Surgeon General's Advisory Committee in an intentionally vague and confusing manner:

527

I am of the further opinion that any description in the letter to the Committee of the methods and steps involved in the various scientific research programs conducted by Brown & Williamson must necessarily be so vague and incomplete as to be irksome to the reader. . . . Therefore, it is my suggestion that we state simply that we have conducted no medical research, having left that to TIRC. . . . I repeat it is unfortunate that Brown & Williamson must submit anything, but this approach seems to me to be the most innocuous of the alternatives.

¶680249785-9786 (US 85391)).

Johnson concluded his letter with the advice that B&W's submission to the Surgeon General's Advisory Committee must protect the company's litigation position, and must contain only material that had already been published: "From a litigation standpoint I believe it is axiomatic that it is best to submit the least scientific material possible consonant with the objective of not irritating the Committee. As I mentioned on the telephone I would prefer to see only previously published material submitted . . . ." 680249785-9786 (US 85391).
In a June 19, 1963 document titled "Note for Mr. Cutchins," BATCo president Ed Finch told his counterpart at B&W that BATCo had sent B&W copies of all the BATCo-sponsored nicotine research conducted at the Battelle Labs. Finch stated that because the reports were "sound piece[s] of research . . . it might be desirable to get them submitted to the U.S. Surgeon General's Committee." Finch also informed Cutchins that the Tobacco Research Council in Britain was sending copies of the nicotine research reports to the TIRC (CTR's predecessor) as well, "with a request that they consider whether it would help the U.S. industry for these reports to be passed on to the Surgeon General's Committee." 689033429-3429 (US 54274).
A letter from BATCo's Sir Charles Ellis to B&W's Yeaman ,dated June 28, 1963, recalled that B&W had already received the "HIPPO" research reports, and enclosed the May 1963

528

¶BATCo report from Dr. Haselbach titled "A Tentative Hypothesis on Nicotine Addiction." MTP0013569-3569 (US 76159).

The "Tentative Hypothesis" document, quoted in detail at Section V(B)(3)(c)(¶1009), supra, closed with the following: "In conclusion, a tentative hypothesis for the explanation of nicotine addiction would be that of an unconscious desire to restore the normal physiological equilibrium of the corticotropin releasing system in a body in which the normal functioning of the system has been weakened by the chronic intake of nicotine." 536480912-0914 (US 20928).
BATCo also forwarded its report titled "The Fate of Nicotine in the Body" to B&W under cover letter from Sir Charles Ellis to chairman Bill Cutchins (stamped "Received") on July 1, 1963. In his cover letter, Ellis wrote:

I feel sure you will agree that a knowledge of the fate of nicotine in the body is a necessary accompaniment to studying the physiological effects that nicotine can produce. I hope you will be interested in the experiments which in my opinion add considerably to the published knowledge in this subject.

¶689033419-3419 (US 54271).

At some point in 1963, B&W was considering providing BATCo-funded Battelle Labs research on the addictiveness of nicotine to the Surgeon General prior to the first Report on Smoking and Health in 1964. B&W changed its mind, as evidenced by a July 3, 1963 cable to BATCo Chairman A.D. McCormick, in which B&W General Counsel Addison Yeaman stated his intention to withhold the research results from the Surgeon General:

Hoyt of TIRC agreed to withhold disclosure Battelle report to TIRC members or SAB until further notice from me. Finch agrees submission Battelle or Griffith developments to Surgeon General undesirable and we agree continuance of Battelle work useful but disturbed at its implications re cardiovascular disorders. . . .

529

We believe combination Battelle work and Griffith's developments have implication which increase desirability [of] reevaluation [of] TIRC and reassessment fundamental policy re health.

¶689033422-3422 (US 22734).

BATCo and B&W shared their PROJECT HIPPO I and II reports with RJR General Counsel Henry Ramm and outside industry counsel Ed Jacob. In an August 5, 1963 letter from B&W General Counsel Addison Yeaman to Ramm and Jacob, B&W enclosed "herewith the three volumes of "Project HIPPO I and II." 689033411-3416 (US 31044).
There is no evidence that the report or its findings were ever shared with the Surgeon General's Advisory Committee. Despite BATCo and B&W's keen interest in nicotine and its impact on smokers' bodies and the extensive research Battelle Labs had conducted for BATCo, B&W never disclosed to the Surgeon General its knowledge that nicotine was addictive, or the research it possessed showing craving, tolerance, withdrawal, and the many physiological effects of nicotine on the body.
The Surgeon General's Report was published in January 1964. The Report did not identify nicotine as an "addiction," finding instead that nicotine was a "habit." This finding was based on the Surgeon General's Advisory Committee's conclusion (1) that smoking created a "desire" but not a "compulsion;" (2) that smoking did not result in a "tendency to increase the dose;" and (3) that smoking did not create a psychological and physical dependence on nicotine. Report of the Surgeon General (1964) at 350-51, VXA1601844-2232 (US 64057).
These findings of the Surgeon General's Advisory Committee, and the Report's ultimate characterization of smoking as a "habit" instead of an "addiction," were in direct conflict with the extensive and sophisticated nicotine research in the possession of B&W in 1963 -- research which was intentionally kept from the Advisory Committee. Moreover, the 1964 finding of "habituation" is in conflict with the internal consensus of opinion at both BATCo and B&W, as stated by Sir Charles Ellis, Addison Yeaman, and company scientists, that nicotine and smoking produced an "addiction," not a mere "habit."

530

There is certainly a possibility, although it is impossible to say from hindsight, that had the Surgeon General's Advisory Committee had full knowledge of Defendants' research and the conclusions to be drawn from such research, his 1964 Report may have accurately identified nicotine as addictive long before that conclusion was reached 14 years later in 1988. Henningfield WD, 114:13-122:19.
In later years, B&W limited its involvement in nicotine research to studying the effects of nicotine on the central nervous system, work done in Europe under BATCo's supervision. This was done, as the following facts show, because of B&W's concern that research demonstrating nicotine addiction or dependence contradicted the industry's public position and might lead to regulation.
Following a visit to B&W in October 1979, BATCo scientist D.G. Felton described the situation as follows:

There is said to be a general nervousness in the U.S. Tobacco Industry (apart from Philip Morris) in working on the effects of nicotine, because of the risk of demonstrating nicotine dependence or addiction. There are fears that this would result in the Industry coming under the Food and Drug Administration. This view was given me both by the CTR administration and separately by [outside industry counsel] Mr. Tim Finnegan. In the latter's opinion, any work concerned with the central effects of smoking or of nicotine would run this risk legally.

531

In an August 16, 1984 memorandum to BATCo counsel Earl Kohnhorst, B&W Senior Vice President and General Counsel Ernest Pepples advised against the use of a report by BATCo scientist R.P. Ferris titled "The Functional Significance of Smoking in Every Day Life" because of the report's concession that "many potential criteria for addiction identification are met by smoking behavior," and its reference to smoking as "one form of 'drug usage', 'psychoactive substance usage,' or 'psychoactive drug usage.'" Pepples called any use of the report by the company "not appropriate or advisable." 682015254-5255 at 5254 (US 23022); 650000563-0740 (US 85393).
In his memorandum to Kohnhorst, Pepples described the "more serious problems" with the Ferris report, which referred to nicotine as a drug, admitted "tolerance and withdrawal," and concluded that the pharmacological effect of nicotine is the "primary motivation" for smoking. Overall, Pepples was very concerned that the report would be used in litigation as evidence that cigarette smoking is addictive, and as a basis for regulation by the FDA. 682015254-5255 (US 23022).
B&W's efforts to block the presentation or use of Ferris's study went further. Soon after, in an August 28, 1984 letter to BATCo deputy chairman Ray Pritchard, Pepples expressed B&W's objection to using the study, its concern that the Ferris study could seriously harm the industry, and its recommendation that BATCo legal counsel be involved in the planning of further research and drafting of reports related to nicotine and addiction. In his letter, Pepples implicitly asked Pritchard to conceal the Ferris study, and stop Ferris from making a presentation on the report at an upcoming research conference, in light of "the current legislative and litigation environment in the U.S." and "the possibility for involvement by the U.S. Food and Drug Administration." Pepples explained that the industry needed to oppose any concessions that nicotine and smoking are addictive "in order not to give a claimant an unjustified weapon to use against the company or the industry." 680583069-3070 (US 23024).

532

As in his earlier memorandum to Kohnhorst, Pepples' letter to Pritchard expressed

¶"great concern" about Ferris's report because it conceded that smoking is addictive. Pepples did not deny any of Ferris' observations or conclusions regarding nicotine and smoking; indeed, he admitted that Ferris' use of authorities and references was "generally accurate." Fearing involvement by the

¶FDA, Pepples then recommended closer involvement by lawyers in scientific projects in the future.

¶He wrote:

[T]he report seems to concede that many potential criteria for addiction identification are met by smoking behavior. For example, the report urges the position that the primary motivation for smoking is ultimately tied to a pharmacological "psychoactive" function of nicotine. . . .

Throughout the report, unfortunate concessions appear regarding "tolerance and withdrawal." The report frequently expresses that smoking has certain "therapeutic properties" and nicotine is compared to the action of tranquilizers, alcohol, etc. In addition, smoking is referred to as one form of "drug usage," psychoactive substance usage," or "psychoactive drug usage."

As you know in the current legislative and litigation environment in the U.S., claims of addiction have been and will be used against Brown & Williamson by our adversaries. Such claims have been vigorously opposed in order not to give a claimant an unjustified weapon to use against the company or the industry.

In addition, the possibility for involvement by the U.S. Food and Drug Administration would be heightened by company or industry promotion of the theme of this report, as it will be generally perceived.

If such matters as the "Functional Significance" document and the Conference binders, enclosed herewith, are not already routinely vetted with BATCo lawyers, you may want to consider involving

533

them more closely in both the conceptual and the drafting stages of these projects. Thank you very much for your help in this area of great concern for us.

¶521016786-6786 (US 22129).

With respect to the Ferris report, B&W attorney J. Kendrick Wells emphasized in a

¶November 12, 1984 letter to BAT attorney Anne Johnson why the BAT study must not be publicized:

A plaintiff in a smoking and health products liability lawsuit in the U.S. could use the paper to support its argument that smoking is difficult to quit ("Addiction"). The plaintiff could argue that the paper contradicts the voluntary assumption of risk defense. It is doubtful whether editing can transform the paper into one which would not be helpful to the plaintiff in a products liability action.

¶680583045-3045 (US 85395).

Around this same time, B&W intervened to edit adverse references to addiction out of another BATCo report, titled "The Controversy on Smoking and Health -- Some Facts and

¶Anomalies" by BAT scientist Dr. L.C.F. Blackman. By letter dated October 25, 1984, B&W attorney J. Kendrick Wells wrote BATCo counsel Alec Morini that "review" of BATCo publications by B&W was necessary in light of ongoing smoking and health litigation; Wells went on to provide

¶45 paragraphs of revisions to Blackman's draft report in a marked-up report These included:

Delete Donald Gould reference. The article identifies cigarettes as a drug.

Delete reference to Dr. W.S. Cain. The article identifies short term and longer term pharmacological and physiological factors as important in the derivation of "habitual cigarette smoking" . . . .

Delete. The point made here might be said to run counter to arguments that cigarette smoking is not addictive . . . .

534

The three paragraphs referenced above bearing adversely on the company's position on addiction were ultimately stricken from the report. 107332541-2574 at 2545 (US 26281); compare to 680582512-2512 (US 85396).
In a May 10, 1994 B&W press release, the company made the following claims -- claims that are patently false in light of the company's pre-1964 acknowledgment that nicotine is addictive and the company's decision not to disclose to the Surgeon General BATCo's internal nicotine research showing addiction prior to the 1964 report:

It has always been B&W's position -- and still is -- that cigarette smoking is not addictive under the standards set forth in the 1964 Surgeon General's Report. Calculated misrepresentations of the company's position merely encourage ill-informed grandstanding. Brown & Williamson was acknowledged by the Surgeon General for its "substantial cooperation and assistance" in connection with the 1964 Report. Contrary to the recent media reports, B&W had not concluded that cigarette smoking was addictive prior to the release of the 1964 Report.

¶202337394-7394 (US 21965).

d. American Tobacco Company 1337. American attempted to keep its limited nicotine research hidden as well. For

¶example, in a September 16, 1938 letter, H.R. Hanmer of American's R & D Department informed George W. Hill, an American Vice President, that research performed on dogs had demonstrated an increase in blood pressure due to the cigarette's nicotine. Mr. Hanmer added that while this was "very clear-cut biological evidence," "nothing of this sort could ever be used in presenting facts to the public." MNAT00115492-5499 (US 21401).

535

e. Tobacco Institute 1338. The Tobacco Institute attempted to ensure that any potentially adverse nicotine and

¶addiction research would not be performed. In a May 17, 1983 memorandum from Fred Panzer to David Henderson, Panzer wrote that certain legislation needed to be amended to make it favorable to the industry by preventing addiction research: "We need language for a rider to the appropriation bill for the National Institute on Drug Abuse (NIDA) that would prevent the use of appropriated funds for a study of the addictive properties of tobacco." TIME 370968-0968 (US 62769).

f. CTR and Other Defendant Funded Research Groups 1339. CTR-selected and funded nicotine research was intended to be favorable to the

¶industry. See Sections III(C)(2) and III(E)(2-3), supra. Lawyers played an important part in carefully considering all nicotine and "psychopharmacology" research before it was started to insure it would stay "pro-industry." Id. Nicotine/behavioral research was discussed by the CTR Director and industry counsel at a July 28, 1976 meeting of the industry Research Liaison Committee, where long-time industry counsel Dave Hardy (of Shook, Hardy & Bacon), American Tobacco counsel Cyril Hetsko, and others commented:

Hetsko: Concerned that such a study [on the benefits of smoking] might play into hands of F.T.C. subpoena fishing for information [regarding] smoker motivation. Would like to see conference proposal checked out before we go ahead. This program goes beyond the organizing committee and should be considered by "committee of counsel." Hardy: Smoking behavior should be part of C.T.R. program as long as it is not "pro-company" but is kept "pro-industry." Hetsko: No problem if it is generated by SAB. This is a totally different area from what SAB has been dealing with. Doesn't want

536

another book "to haunt us," as the one from the "Caribbean Caper" did. Yeaman: We take our direction from our members – the industry members. C.T.R. so far is clean of F.T.C. investigation, except possibly for the St. Martin conference. Hardy: Dr. Gardner should proceed with planning but not take any action. Hetsko: Decision for action should be made by lawyers, not C.T.R. or Organizing Committee. Chronologically, this meeting might be occurring just at a time that some of these experts are also being questioned by F.T.C. about motivation. This convergence might result in intensification of the conflict. Suggests Dr. Gardner present his program for review by all the lawyers. No records of such a review are to be kept.

¶1003719175-9179 (US 86406).

The book from the "Caribbean Caper" that, according to Hetsko, "haunted" the tobacco industry, was a book edited by Philip Morris's Dunn and titled "Smoking Behavior: Motives and Incentives." The book was the result of the 1972 nicotine conference on the Caribbean island of St. Martin, where Dunn recalled that, "The majority of the conferees would go even further and accept the proposition that nicotine is the active constituent of cigarette smoke. Without nicotine, the argument goes, there would be no smoking." 2023193286-3304 at 3289 (US 22967). See discussion at Sections III(E)(2)(b)(¶¶264-265) and V(B)(3)(a)(¶¶903-905), supra.
The book contained some outside researchers' views that smoking and nicotine had characteristics suggesting addiction. For example, Murray Jarvik's article in the book acknowledged evidence that nicotine was "the chemical underlying the smoking habit," and stated his personal opinion that "nicotine is the reinforcing agent in smoking." Another writer, Caroline Thomas, recognized "addictive smoking" as one type of smoking. A third author, Neal Miller, alluded to

537

¶"anecdotal evidence" that nicotine administration in rats leads to withdrawal symptoms. The conference and the book were sponsored by CTR. LD90011031-0330 (US 87320).

In November 22, 1977, CTR Associate Research Director Donald H. Ford stated the following with respect to nicotine in a proposal for in-depth CTR-funded nicotine research:

[I]t now seems evident that nicotine, like narcotics, influences the CNS in multiple ways involving effects related to most known neurotransmitters Further, the dependence which develops tobacco in humans (and withdrawal symptoms during the cessation of smoking) and the degree of tolerance to nicotine which occurs in certain animal paradigms strongly suggest that nicotine is a habituating agent.

¶1000041912-1918 at 1912 (US 20073).

Dr. Ford presented his nicotine observations at a November 1977 CTR meeting. His proposed avenues of research related to "Receptors and sites of nicotine action," neurochemical studies, the effects of nicotine on fetal development, neuroendocrinology, and behavioral responses to nicotine. Id.
In response to Dr. Ford's presentation and other CTR nicotine research, Philip Morris's Tom Osdene wrote to Robert Seligman on November 29, 1977, that "we are in the process of digging our own grave." He wrote further: "I am very much afraid that the direction of the work being taken by CTR is totally detrimental to our position and undermines the posture we have taken to outsiders." 2022246952-4952 (US 36865).
Janet Brown, long-time outside industry counsel for American, reported on Ford's CTR research in her minutes of a February 1, 1978 meeting of industry counsel. Her detailed notes of the meeting revealed Defendants' knowledge about the importance of nicotine for smoking, and the importance of stopping Ford's nicotine research, when she discussed her opposition to Ford's central nervous system study. She wrote that while CTR President Addison Yeaman told her that

538

¶Ford's nicotine research, which included the goal of finding a "nicotine blocker or substitute," was

¶"mere speculation," she nonetheless responded as follows:

I said the "speculation" was dangerous and the work had some important commercial implications. A nicotine "blocker" or "substitute" could put the industry out of business overnight. Any information about it, or about CNS reasons "why people smoke," reaching one member before the others could give that member an enormous competitive advantage in developing a 'blocker' for the "blocker," or in producing a "substitute" product, or a purely "tranquilizing" or purely stimulant product. I do not know what all the commercial ramifications are, but they suggest themselves to me as vast. These are arenas that CTR has traditionally steered well clear of and it must continue to do so.

¶968148608-8639 (US 88840).

Industry counsel quickly made sure that Dr. Ford's proposal never received funding.

¶As recited in the May 10, 1978 notes of the Industry Technical Committee Chairman Preston Leake

¶(scientific director for American) to Arnold Henson (General Counsel for American), the proposed nicotine work was "ruled out" by outside counsel Ed Jacob. 955017148-7154 at 7149-7150 (US

¶87172).

Philip Morris's Osdene and Seligman met with CTR Directors Gardner and Hockett at CTR in New York on January 5, 1978. Osdene's memorandum of the January 5 meeting states:

Dr. Seligman brought up the [CTR] grant by Dr. Abood in which one of the stated aims was to make a clinically acceptable antagonist [or blocker] to nicotine. This goal would have the potential of putting the tobacco manufacturers out of business.

539

A series of CTR documents illustrate the attempts, and ultimate failure, of Dr. Avram Goldstein and Dr. Leonard Cornell to obtain CTR funding for a new addiction research facility. Dr. Goldstein's and Dr. Cornell's research specifically proposed an investigation by his Addiction Research Foundation of "nicotine receptors in the brain" and "the mechanism(s) of dependence on nicotine." It was the opinion of CTR chairman Addison Yeaman that "Dr. Goldstein's scientific credentials are of the highest." Dr. Seligman of Philip Morris was impressed by Dr. Goldstein's objectivity and intelligence. 03740559-0567 (US 88548); 686052326-2335 (US 88549); 686052262- 2263 (US 88550); 026474-6475 (US 88551); 1003177412-7413 (US 88552); 1003728001-8007 (US 88554); 686052267-2289 (US 88555); 85681034-1034 (US 88556); 686052258-2259 (US 88557); 686052293-2296 (US 88558).
Despite these views of the scientists' abilities, the industry decided to give no support to Dr. Goldstein, Dr. Cornell, and the Addiction Research Foundation. The rationale for the decision was spelled out in a September 19, 1978 memorandum from C.I. Waite to H.R. Kornegay (of the Tobacco Institute), with copies to Bill Shinn (of Shook, Hardy & Bacon) and Ernie Pepples (of B&W):

Mr. Cornell's foundation actually assumes tobacco (nicotine) is addictive and costs the U.S. citizen 42 billion dollars a year. He also believes tobacco causes 300,000 premature deaths each year. And he wonders if this is why we might not be interested.

540

BATCo scientist D.G. Felton visited CTR in October 1979, where he was escorted by industry counsel Tim Finnegan from Jacob & Medinger. In his typed notes of the trip to CTR, Felton recorded the following:

I then asked about possible legal problems arising from work on beneficial effects of smoking. In Mr. Finnegan's opinion, any work concerned with central effects of smoking or nicotine would run the risk that FDA would become involved with tobacco, something that was to be avoided, if possible.

¶100651251-1312 at 1299 (US 85402*).

Shortly thereafter, in a larger meeting with CTR President Yeaman, Scientific Director Gardner, and CTR scientists, Felton also inquired into Leo Abood's nicotine work. He was told of the Defendants' decision to terminate his research given the risk of demonstrating addiction:

The discussion passed to effects of nicotine and the reasons why CTR did not continue their grant to Leo Abood. There is a general nervousness in the US Industry (apart from Philip Morris) in working on the effects of nicotine, because of the risk of demonstrating nicotine dependence or addiction.

¶100651251-1312 at 1299-1300 (US 85402*).

A June 20, 1984 memorandum written by Shook, Hardy & Bacon attorney Wendell L. Stone chronicled much of the CTR-funded nicotine research, and concluded that Defendants' termination of Abood's "nicotine receptor" work could be used by plaintiffs "to make a point regarding CTR that when research by its grantees appeared to be incriminating of smoking, then the CTR grants were terminated." 515709297-9340 at 9299 (US 20866).
On the other side of the Atlantic, the industry's Tobacco Advisory Council (TAC), which was the European counterpart of the Tobacco Institute, was also screening research results to ensure that "anti-industry conclusions" were not made public. One particular example will suffice.

541

Long-time tobacco industry-affiliated/funded scientists Francis Roe and Jeffrey Cohen were asked to prepare a "Nicotine Monograph" in 1977 for the member companies of the Tobacco Advisory Council (including Philip Morris, RJR, and BATCo). 2501160364-0371 at 0369 (US 87173).
Dr. Roe forwarded the first draft of the monograph to D.H. Beese at the TAC under cover letter dated July 30, 1979, for review by the member companies; BATCo produced a copy of the draft "monograph" and Roe's letter, which stated that "It may well be that parts of the text will need to be expanded and the 'conclusions' section given a new title or omitted. . . . I shall look forward to hearing from you and having a reaction from the Companies in due course." 1000138177-8237 at 8177 (US 87174).
Roe and Cohen stated the following in a draft "Monograph" section titled "Smoking Behaviour: Role of Nicotine in the Smoking Habit":

There is now increasing evidence that the presence of nicotine may be the major factor responsible for the widespread use of tobacco in all human societies. . . . Whilst smoking fulfils a psychological need in certain individuals it is only the inhaling cigarette smoker who is likely to gain psychopharmacological satisfaction from nicotine and become dependent on it. Nicotine has been described as a psychoactive agent with tranquillizing, antianxiety, stimulant, depressant, antiagression, mood stabilizing and stress-attenuating properties.

¶1000138177-8234 at 8219 (US 87174).

In the "Conclusions" section of Roe and Cohen's draft "Nicotine Monograph," the authors emphasized that:

The present worldwide campaign toward low-tar, low nicotine cigarettes faces the problem that nicotine-seeking smokers will need to inhale more smoke to obtain their nicotine requirement and in

542

doing so inhale more tar. . . . Because of the weak absorption of nicotine from buccal and alimentary systems, chewing nicotine gum as a possible alternative vehicle to smoke inhalation would prove much less satisfying to the craving cigarette inhaler .

¶1000138177-8234 at 8221 (US 87174).

These observations and conclusions did not survive review by the TAC and its member companies. Roe and Cohen's "Nicotine Monograph" was eventually published in 1981 by the TAC on behalf of the tobacco industry under the title "Monograph on the Pharmacology and Toxicology of Nicotine." In the published version of the "Monograph, the "Smoking Behaviour" section quoted above was edited dramatically. The statement that nicotine may be the "major factor responsible for the widespread use of tobacco in all human societies" was deleted entirely. The fact that an "inhaling cigarette smoker" will become "dependent" on smoking was deleted. In the "Conclusions" section, there is no mention of "nicotine-seeking smokers" or the "craving cigarette inhaler." The TAC and its member companies controlled the "Monograph" scientific review, and made sure that Roe and Cohen's document was industry-favorable on the issues of nicotine and addiction. 2021585328-5378 at 5365-5368 (US 87175).

Conclusions 1359. For approximately forty years, Defendants publicly, vehemently, and repeatedly

¶denied the addictiveness of smoking and nicotine's central role in smoking. They made these denials out of fear that public acknowledgment of what was so well documented and widely accepted internally within their corporate offices and scientific laboratories could result in governmental (i.e., FDA) regulation, adverse liability judgments from addicted smokers suffering the adverse health effects of smoking, loss of social acceptability of smoking, and the ultimate loss of corporate profits.

543

¶The evidence spelled out above is simply overwhelming that Defendants knew that smoking is addictive and knew that nicotine is the agent creating and sustaining that addiction. There is also overwhelming evidence that even though Defendants have known internally about addiction for decades, they have endeavored to keep the extensive research and data they had accumulated out of the public domain and out of the hands of the public health community by denying that such data existed, by refusing to disclose it, and by shutting down or censoring laboratories and research projects which were investigating the mechanisms of nicotine.

Defendants assert that the public health community and the public itself has known for decades that nicotine produced dependence. For example, Defendants cite to the 1962 publication of the well respected Larson, Haag and Silvette compendium, Tobacco Experimental and Clinical Studies, which described nicotine's effects on the human nervous system and summarized existing research suggesting that people smoke to obtain nicotine, that nicotine has pharmacological effects, and that nicotine is addictive or habituating. (no bates) (JD-000500). Defendants also cite to the United States Supreme Court comment that, when Congress enacted the Federal Cigarette Labeling Act in 1965, "the adverse health consequences of tobacco were well known, as were nicotine's pharmacological effects." Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 138 (2000). Even if there is truth to Defendants' speculation that "everyone knew" of nicotine's addictiveness, there is no question that the public health community lacked the substantial and sophisticated understanding of nicotine's effects and role that Defendants possessed. Put quite simply, if the Surgeon General of the United States possessed the information and data Defendants possessed prior to publication of his 1964 Report, it is simply not possible that he would have ignored it.

544

Moreover, there is a basic inconsistency in Defendants' position. If, in fact, "everybody knew" that smoking and nicotine were addictive, then why were Defendants publicly, vehemently, and repeatedly denying it?
Defendants' denials misled the public about why quitting smoking is so difficult, exactly how difficult it is, and about why failure to quit is not simply a function of personal weakness or lack of willpower. In short, after reassuring the smoker that smoking was not bad for her health, and was not addictive, Defendants then blamed her for being unable to stop using the product they had so successfully marketed with false information.
Defendants did not simply deny that smoking warranted the label "addiction"; they denied the entire concept of physiological dependence. The semantic battle Defendants have waged in the public realm and at trial is a distraction from the fact that, whether using the word "dependence" or "addiction," the core concept is the compulsive and uncontrollable use of nicotine reflected in drug-seeking and drug-taking behavior, all of which Defendants deny exist.
Based on the extensive individual Findings of Fact set forth in this Section, the Court finds that Defendants have known for decades that cigarette smoking was addictive, and that nicotine is the addicting element in smoking behavior. Defendants' false and misleading statements relating to addiction continue even today.
Moreover, Defendants deliberately and intentionally hid this information from the public and closed down research laboratories and on-going projects in order to ensure secrecy. Time and time again, Defendants falsely denied these facts to smokers and potential smokers, to government regulatory authorities, to the public health community and to the American public.

545