United States v. Philip Morris USA Inc.: Amended Final Opinion · 2006
Defendants Concealed and Suppressed Research Data and Other Evidence that Nicotine Is Addictive
Defendants Concealed and Suppressed Research Data and Other Evidence that Nicotine Is Addictive
¶1266. As demonstrated, Defendants' internal documents reflect a sophisticated understanding of nicotine and its role in creating smoking addiction -- an understanding that is totally inconsistent with their long-standing public denials that nicotine is addictive. In addition, it is clear that Defendants intentionally withheld from public dissemination, from the public health community, and from government authorities, accurate and important information regarding the addictiveness of nicotine in cigarettes. Henningfield WD, 87:10-88:20, 161:23-167:6.
¶1267. Defendants suppressed their own extensive research findings discussed in Section V(B)(3), supra, supporting the conclusion that nicotine is addictive, and fostered controversy about the extent of scientific knowledge concerning nicotine and its addictive effects that was publicly available. Henningfield WD, 134:23-136:9, 161:23-167:6.
¶1268. As that evidence shows, Defendants themselves possessed, from their own in-house and external research, information that led them to conclude, long before public health bodies did, that the primary reason people keep smoking cigarettes is to obtain the drug nicotine, which is addictive. Defendants intentionally withheld this data (including many of studies on the physiological effects of nicotine in animals and humans, and much of their research on the determinants of nicotine dosing in cigarettes) when there were major public efforts to review and synthesize all available information. This occurred with the preparation of both the 1964 and 1985 Surgeon General's Reports and numerous congressional investigations. Defendants also engaged in a decades-long, elaborate, sophisticated, well-funded public relations offensive, denying and attacking the consensus conclusion they had long ago reached internally, but that the less well-funded public health community was belatedly reaching, that smoking is addictive primarily because cigarettes effectively deliver nicotine. Henningfield WD, 87:10-103:13, 104:14-110:8, 134:23- 136:1, 150:14-159:8, 161:23-167:6. See also 490010042-0044 at 0043 (US 79285) (presenting "Addiction Statement," prepared by Shook, Hardy & Bacon, deciding the company's position must be that smoking is not addictive and that, "Statements in company documents cannot refute this conclusion.").
510¶1269. A September 9, 1980 Tobacco Institute internal memorandum revealed the recognition by the member companies that a public admission that nicotine was addictive would undermine their litigation defense that a person's decision to smoke is a "free choice":
[T]he entire matter of addiction is the most potent weapon a prosecuting attorney could have in a lung cancer/cigarette case. We can't defend continued smoking as "free choice" if the person was "addicted."
¶TIMN0107822-7823 at 7823 (US 21275).
¶1270. A second reason Defendants denied addiction was to avoid regulation by the FDA. None of the companies' internal research and evidence about addiction was submitted in 1996 when the FDA sought to assert jurisdiction over cigarettes as drug (nicotine) delivery devices. Instead, Defendants vigorously denied every aspect of addiction. 25055597781-7998G (US 23028*).
¶1271. The following are examples of the actions Defendants undertook to either block or limit the nature and dissemination of nicotine-related research, as well as any evidence suggesting addiction.
511Philip Morris
¶1272. As already discussed, Philip Morris intensively studied nicotine and both its pharmacological and physiological effects on smokers (sometimes called addictive, dependence-producing, or reinforcing effects) in an effort to increase its market share within the industry. However, Philip Morris withheld from the public its internal knowledge and acceptance that smoking, because of nicotine, was addictive. Similarly, Philip Morris's research demonstrating the addictive impact of nicotine on the bodies of animals and humans was suppressed, and in some cases terminated.
¶1273. In a 1992 memorandum titled "Philip Morris Behavioral Research Program," the company's long-time outside counsel, Shook, Hardy & Bacon, reviewed and summarized much of Philip Morris's nicotine research conducted from 1969 to 1984 under the direction of Principal Scientist William L. Dunn. The research into nervous system effects and smoking behavior was conducted both internally (by scientists such as Dunn, Berntson, Gullotta, DeNoble and others) and by outside researchers (including scientists Hutchinson, Abood, Egle and others). 2021423403-3497 at 3406-3409 (US 36743).
¶1274. The funding for the Behavioral Research Program, or Nicotine Program as it was sometimes called, was terminated without explanation in 1984. 2025768108-8166 at 8113 (US 36743).
¶1275. Discussing Philip Morris's research into the pharmacological effects of nicotine, Dr. Dunn wrote the following in a "CONFIDENTIAL" memorandum to Research & Development Vice President Helmut Wakeham on February 19, 1969: '[D]o we really want to tout cigarette smoke as a drug? It is, of course, but there are dangerous F.D.A. implications to having such a conceptualization go beyond these walls." 1003289921-9922 at 9921 (US 20167).
512¶1276. Dunn wrote a "CONFIDENTIAL" memorandum dated October 19, 1977 titled "Smoker Psychology Program Review" summarizing his program for Tom Osdene. Dunn made three observations that represented the Philip Morris position on smoker behavior and nicotine research. First, the mission of the Philip Morris program was to "study the psychology of the smoker in search of information that can increase corporate profits." Second, Dunn admitted that while "[t]here is a general realm of psychological inquiry that would not make our lawyers nervous were the findings to be made public," there is "legal concern" with any scientific inquiry into the dependency-producing compound, or "reinforcing mechanism," of smoking. Third, Dunn stated that his research assumed that nicotine was the compound in question, a compound without which "the cigarette market would collapse, P.M. would collapse, and we'd all lose our jobs and consulting fees." 1000046538-6546 at 6538-6542 (US 26074); 2021423403-3497 at 3488 (US 36743).
¶1277. Dunn also compared smokers seeking nicotine to Pavlov's dogs and to hungry laboratory rats who press levers seeking food pellet "rewards":
Consider the smoker. Smoking the cigarette is the lever press. The effect of that smoking act upon the person is the reward. That effect reinforces the smoking act. He comes to push the smoking lever 10 to 60 times per day.
¶1000046538-6546 at 6543 (US 26074); 2021423403-3497 at 3485 (US 36743).
¶1278. Shortly thereafter, in a November 3, 1977 memorandum, Dunn revealed his strategy for concealing any unfavorable nicotine research results. Regarding a proposed study of nicotine withdrawal in rats to be undertaken by Philip Morris scientist Carolyn Levy, Dunn stated that he approved it. However, he cautioned that, "If she is able to demonstrate, as she anticipates, no withdrawal effects of nicotine, we will want to pursue this with some vigor. If, however, the results with nicotine are similar to those gotten with morphine and caffeine, we will want to bury it." 1003293588-3588 (US 20168).
513¶1279. The terms of Levy's "Proposed Study of Nicotine Withdrawal in Rats" are contained in a November 1, 1977 memorandum from her to Dunn, where Levy states her hypothesis that her research would show that there are no withdrawal symptoms associated with nicotine. Levy intended to compare known morphine and caffeine withdrawal symptoms to nicotine's effects. Levy stated, however, that while she predicted favorable results, she understood that "it is dangerous to set out to prove the null hypothesis." 1003293589-3591 (US 21421).
¶1280. Robert Seligman, Vice President of Research & Development at Philip Morris, wrote a memorandum to company general counsel Alex Holtzman dated June 27, 1978, attaching Dunn's report of a conference Seligman and Dunn attended called "Cigarette Smoking as a Dependence Process." The conference was apparently put on by the National Institute on Drug Abuse. Seligman prophetically warned Holtzman that:
It is my impression that at some time in the future, nicotine will be listed as a dependency drug (or smoking will be listed as a dependence process). Thus, it might be wise to contemplate the future legal ramifications of such an inevitability. Additionally, you might want to consider some mode of action which might forestall such a designation by the drug abuse community.
¶1003726420-6420 (US 85384) (emphasis in original).
¶1281. A memorandum to Seligman from J.I. Seeman, dated March 18, 1980, provided additional commentary on the Philip Morris "Nicotine Receptor Program." In Seeman's memorandum, he implied that any outside scientist working with Philip Morris had to share the company's interest. He wrote that, "An additional, and perhaps fundamental, requirement was that the individual(s) chosen to work with us is acceptable from a 'political' perspective." 1003289974- 9975 (US 87078).
514¶1282. Dunn wrote an internal memorandum to Seligman dated March 21, 1980, describing Philip Morris's "Nicotine Receptor Program," an internal company research program focusing on the psychopharmacology of nicotine. The research was "aimed at understanding that specific action of nicotine which causes the smoker to repeatedly introduce nicotine into his body." While Dunn stated that the nicotine research would likely produce "significant scientific developments," he noted that it was "a highly vexatious topic" that company lawyers did not want to become public because nicotine's drug properties, if known, would support regulation of tobacco by the FDA. Dunn wrote, "Yet this is where our attorneys least want us to be." Moreover, lawyers were concerned that new "knowledge of nicotine" might permit "therapeutic breakthroughs to reduce the incidence of smoking." 0000127789-7792 (US 35152).
¶1283. Consequently, Dunn observed that while Philip Morris would continue its research program "to study the drug nicotine, we must not be visible about it." And while the program depended on a "heavy commitment" by Philip Morris, Dunn wrote that "our attorneys, however, will likely continue to insist on a clandestine effort in order to keep nicotine the drug in low profile." Dunn mentioned Shook, Hardy & Bacon's Don Hoel and Jacob & Medinger's Ed Jacob by name in his memorandum. 0000127789-7790 (US 21794).
¶1284. A March 16, 1983 memorandum from researchers James Charles and Victor DeNoble concerning their critiques of the Public Health Service's Report titled "Why People Smoke" acknowledged that Philip Morris had research results with implications contrary to the company's publicly stated opinions on nicotine, but that Philip Morris had not disseminated those findings publicly: "Recent experiments in Vic's [DeNoble's] project have shown that there is a behavioral component to tolerance (a learned phenomenon), but this work has not been published." 1005061346-1346 (US 20199). This was the work, described below, led by Drs. DeNoble and Mele. Mele WD, 11:6-15:4.
515¶1285. Under the guidance of Drs. DeNoble and Mele, the Philip Morris Biochemical Research Division developed an important method for demonstrating that rats press levers and will work for nicotine. Such studies had been done earlier with monkeys, but there had not previously been a good rat model. Philip Morris was one of the first to develop a valid rat model for nicotine intravenous self-administration. As outlined infra, Philip Morris prevented the publication and presentation of this important new work, claiming the methodology was flawed. Henningfield WD, 161:23-167:6; DeNoble WD, 17:1-18:6, 22:6-23:18, 39:12-45:11; Mele WD, 20:3-22:12, 28:13- 32:4.
¶1286. Drs. DeNoble and Mele had also demonstrated, by administering nicotine to rats, the existence of both physiological and behavioral tolerance to nicotine. Mele WD, 11:6-13:5. Behavioral tolerance -- when tolerance develops to a behavioral effect of a drug -- had not been shown prior to this research. Id. at 12:16-13:10. When Dr. Mele sought to publish this groundbreaking research in 1983, Philip Morris informed him that the tolerance study could not be published "because the study showed tolerance and physical dependence to nicotine." Id. at 14:2-10. Instead, Philip Morris would only allow Dr. Mele to write for internal consumption. Id.; 1000413881-3964 (US 20100).
516¶1287. Shook, Hardy & Bacon commented on an unpublished manuscript from Drs. DeNoble and Mele titled "Development of Behavioral Tolerance Following Chronic Nicotine Administration," that "[t]he bottom line is that the authors are maintaining that there is tolerance to nicotine, which involves both behavioral and physiological factors." The memorandum noted that such a finding would be detrimental to the cigarette industry:
It is obvious that such a report has undesirable implications for smoking and health litigation. Tolerance is frequently cited as one of the hallmarks of addiction. It is the industry's position that one of the classic criteria for addiction is tolerance, and that such has not been demonstrated in the case of nicotine. While it is true that the Mele and DeNoble paper does not discuss smoking in particular or attempt to extrapolate their experimental findings beyond the laboratory, there is nevertheless the implication simply by the fact that Philip Morris is doing this research, that it is viewing this research as relevant to smoking behavior.
¶2021424402-4412 at 4404-4405 (US 22847).
¶1288. In the same memorandum, Shook, Hardy & Bacon pointed out the legal implications of the "unfavorable" Philip Morris internal nicotine research:
Research engaged in, as well as some possibly under consideration, by Philip Morris has undesirable and dangerous implications for litigation positions the industry takes in regard to smoking behavior. The pharmacological nature of the research implies strongly a view of the importance of nicotine. What is worse, research reports under Philip Morris' sponsorship contain claims of unequivocal demonstrations of reinforcement by nicotine in animals. This kind of research is a major tool of our adversaries on the addiction issue; the irony is that industry-sponsored research is honing that tool. In the final analysis, the performing and publishing of nicotine related research clearly seems ill-advised from a litigation point of view.
¶2021424402-4412 at 4412 (US 22847); 2021423403-3461 at 3422 (US 87038*).
517¶1289. The intravenous self-administration rat model is considered a classic indicator that a substance has abuse potential. Using that model, and the same procedure that NIDA used to demonstrate abuse potential, the Philip Morris DeNoble study demonstrated the abuse potential of nicotine. DeNoble WD, 17:9-20:2; See also, 2023963269-3341 at 3312-2213 (US 20398) (DeNoble testimony at 1994 Waxman hearings).
¶1290. DeNoble's rat studies on self-administration and tolerance succeeded where others had failed and clearly were very significant at that point in history. DeNoble WD, 17:9-18:6. As DeNoble explained in his testimony before the Waxman Subcommittee in 1994:
The work that we did with nicotine was clearly some years ahead of the external community, scientific community. It wasn't until 1989 that Bill Corgal (sp) demonstrated that nicotine would function as an intravenously delivered reinforcer for rats, using the same models that I used -- that Paul [Mele] and I used. The work that we did on self administration, on dependence, on tolerance, on frustration, clearly would have moved the scientific community much further along than it had been moved by that work not getting out.
¶2023963269-3341 at 3285 (US 20398). This assessment echoes Dr. Henningfield's view about the adverse impact that Philip Morris's concealment had on the scientific research community. Henningfield WD, 162:10-167:6.
¶1291. DeNoble's research colleague at Philip Morris, Dr. Paul Mele, also agreed with this analysis in his testimony before the Waxman Subcommittee in 1994:
518. . . [S]ome of these studies were the first to be done with nicotine. I have no doubt that other people would have performed these studies subsequently just as has been done recently in Toronto. But they weren't being done at the time, and to quote a recent review article in Science . . . it basically took six or seven years for the nicotine self-administration model to be developed and come out. Whereas, it would have been out much earlier had this work been allowed to go out and stay out.
¶2023963269-3341 at 3286 (US 20398).
¶1292. Philip Morris management fully appreciated the scientific significance of the DeNoble rat self-administration nicotine study. At first, Dr. DeNoble obtained approval to submit it to a leading peer review scientific journal, Psychopharmacology, and there were plans to present results of the study at the 1983 American Psychological Association meeting in Anaheim, California. 2023963269-3341 at 3303 (US 20398).
¶1293. Prior to publication, at a 1982 presentation at corporate headquarters on the activities of the behavioral pharmacology laboratory including the results of the rat self-administration nicotine study, DeNoble was asked only one question, by the President and CEO of Philip Morris, Ross Millhiser: "Why should I risk a billion-dollar industry on rats pressing a lever to get nicotine?" DeNoble WD, 24:8-25:1.
¶1294. The saga of the Philip Morris Nicotine Program is summarized in detail in a lengthy 1992 document prepared by outside counsel Shook, Hardy & Bacon titled "Philip Morris Behavioral Research Program." In this report, counsel describe many aspects of the program and cite specific documents showing a major internal research initiative that lasted from 1969 to 1984, involving many scientists, including DeNoble and Mele. The report makes clear that the program generated results and was still generating data in 1984 related to nicotine receptors, analogs, peripheral nervous system effects, central nervous system effects, effects on animal behavior, and differences between high nicotine delivery and low nicotine delivery cigarettes. 2021423403-3497 at 3408-3409 (US 36743).
519¶1295. In a July 27, 1983 letter to the head of Philip Morris, Shook, Hardy & Bacon attorney Patrick Sigrid summarized the nicotine research being conducted by DeNoble and recommended its suppression. 2046754720-4731 (US 20476).
¶1296. In April 1984, a few months after a top Philip Morris executive and lawyer visited the behavioral pharmacology lab, DeNoble's laboratory was suddenly, with no warning, preparation, or explanation, shut down and the animals killed. DeNoble WD, 38:4-16, 39:3-9; Mele WD, 25:19- 26:21. In DeNoble's own words, "[O]ur laboratory was terminated in one day." 2504099642-9666 at 9660 (US 22708).
¶1297. Subsequently, DeNoble was told by several representatives of Philip Morris management that his lab was producing information that the company did not want generated internally. As DeNoble testified at a Congressional hearing:
Apparently, at that same time, some litigation had come out, some law suits, and we were told that the data we were generating, the types of studies that we were doing would not be favorable in that litigation. . . . They just said that if the work were removed from the company connecting it back to the company would be, you know, more difficult to do than if it's being done right in the company itself.
¶2023963269-3341 at 3305-3306 (US 20398); See also, DeNoble WD, 38:12-14.
¶1298. In 1986, Dr. DeNoble and Dr. Mele presented their findings on behavioral tolerance development to nicotine in rats to the Federation of American Societies for Experimental Biology in St. Louis, Missouri. In April that year, Philip Morris Companies Assistant General Counsel Eric A. Taussig sent each scientist a letter which stated in part:
520As you are aware, upon your employment at Philip Morris . . . you signed an agreement (a copy of which is enclosed) requiring you to keep confidential, unless expressly permitted otherwise, research developed while an employee of the Company. The disclosure of
such information as a result of your employment at Philip Morris without permission constitutes a breach of your agreement with the Company. In the future, you are expected to comply with the terms of the agreement.
¶DeNoble WD, 39:12-42:20; Mele WD, 28:13-30:22; 2047340350-0350 (US 22772); 2077541354- 1354 (US 44603).
¶1299. DeNoble perceived this letter to be a threat of future litigation. In a September 10, 1986 letter, Taussig again threatened DeNoble and Mele with litigation if they published, or presented, their findings on nicotine self-administration and brain effects, accusing DeNoble of disclosing "information relating to research on a project titled 'Brain Sites Involved in the Mediation of Behavioral Effects of Intraventricularly Administered Nicotine." Taussig wrote that Philip Morris was aware that they had on two occasions already presented the results of their nicotine research, allegedly in violation of their employment termination agreement. He informed them that "the Company cannot tolerate this type of conduct," and reiterated that "if you wish to publish or otherwise utilize research from Philip Morris, you must request and receive permission from the Company." He ended the letter by stating that "[a]ny further breach of your agreement will result in action being taken." 2023192361-2362 (US 20380). DeNoble was released from his confidentiality agreement with Philip Morris in 1994. DeNoble TT, 1/6/05, 9043:19-23.
¶1300. An April 1994 Shook, Hardy & Bacon report titled "Philip Morris Research of Nicotine Pharmacology and Human Smoking Behavior" pinpoints exactly which research was never made public and the relationship of that research to Philip Morris products. When describing the "Nicotine/Acetaldehyde" research conducted by DeNoble in 1982, research that showed that acetaldehyde and nicotine functioned as "positive reinforcers," the Shook, Hardy & Bacon report admitted that the research was never published:
521CAVEAT: This research has never been published. There is nothing in the literature regarding the synergistic effects of nicotine and acetaldehyde. In addition, see description below re: Frank Ryan data on predicting sales.
Upon learning that acetaldehyde functions as a positive reinforcer, they endeavored to study the combined effects of nicotine and acetaldehyde on self-administration. Results indicated that reinforcing effects of these agents are additive.
Research done by Frank Ryan indicated that acetaldehyde and nicotine data could be used to predict cigarette sales at a 96% accuracy. . . . Frank Ryan ran a program and was able to predict blindly which cigarettes would sell and which wouldn't based on the combination of nicotine and acetaldehyde delivery.
¶2046819241-9268 at 9249-9250 (US 85265*).
¶1301. In a later section of the 1994 report, Shook, Hardy & Bacon described how nicotine research undermined Philip Morris's public position denying addiction, and could invite regulation by the FDA:
¶D. 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."
522DeNoble 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
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).
¶1302. 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*).
¶1303. 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*).
¶1304. 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).
¶1305. 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).
BATCo
¶1306. 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¶1307. 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).
¶1308. 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":
525
- 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 . . .
- 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).
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.
¶1310. 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).
¶1311. 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." 650344433- 4493 at 4439 (US 53468).
526¶1312. 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).
¶1313. 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).
¶1314. 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.
¶1315. 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:
527I 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)).
¶1316. 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).
¶1317. 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).
¶1318. 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).
¶1319. 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).
¶1320. 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).
¶1321. 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:
529Hoyt 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. . . .
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).
¶1323. 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.
¶1324. 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).
¶1325. 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¶1326. 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.
¶1327. 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.
¶1328. 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.
¶650032772-2786 at 2783-2784 (US 85385).
531¶1329. 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).
¶1330. 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).
¶1331. 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¶1332. 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.
533If 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
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).
¶1333. 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).
¶1334. 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" . . . .
534
- Delete. The point made here might be said to run counter to arguments that cigarette smoking is not addictive . . . .
¶680582499-2507 at 2500 (US 54052).
¶1335. 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).
¶1336. 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).
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).
535Tobacco 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).
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."
536Hetsko: No problem if it is generated by SAB. This is a totally different area from what SAB has been dealing with. Doesn't want
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).
¶1340. 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.
¶1341. 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).
¶1342. 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).
¶1343. 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.
¶1344. 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).
¶1345. 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 Ford's nicotine research, which included the goal of finding a "nicotine blocker or substitute," was "mere speculation," she nonetheless responded as follows:
538I 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).
¶1346. 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).
¶1347. 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.
¶1000286213-6214 at 6213 (US 35204).
539¶1348. 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).
¶1349. 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. 686052246-2246 (US 88559).
540¶1350. 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*).
¶1351. 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*).
¶1352. 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).
¶1353. 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¶1354. 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).
¶1355. 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).
¶1356. 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).
¶1357. In the "Conclusions" section of Roe and Cohen's draft "Nicotine Monograph," the authors emphasized that:
542The 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
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).
¶1358. 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).