Reports that Matter

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

Internally, Defendants Recognized That ETS is Hazardous to

Section 79 of 129

Internally, Defendants Recognized That ETS is Hazardous to

Nonsmokers 3362. Defendants recognized that secondhand smoke contained high concentrations of

carcinogens and other harmful agents. Defendants also recognized that the research from the public health community showing that ETS caused disease was persuasive evidence of the harmful effects of secondhand smoke and could be adverse to their position. Most importantly, research funded by Defendants themselves provided evidence confirming the public health authorities' warnings that nonsmokers exposure to cigarette smoke was a health hazard.

  1. Philip Morris had recognized long before the 1980s that sidestream smoke contained known carcinogens. In 1961, scientist Helmut Wakeham presented a paper to the Research & Development Committee cataloguing known gas and particulate chemicals in cigarette smoke, including those that Wakeham acknowledged had been identified as carcinogens. According to Wakeham's analysis, 84% of cigarette smoke was sidestream smoke. 2024947172-7196 (US 22891).

  2. According to a March 30, 1980 document, a Philip Morris scientist reviewed the 1980 paper by James White and Herman Froeb, titled "Small Airway Dysfunction in Nonsmokers Chronically Exposed to Tobacco Smoke." White and Froeb concluded in their study that nonsmokers exposed to secondhand smoke suffer significant damage to airway function. The Philip Morris scientist wrote to Tom Osdene and Jim Charles, "I have reviewed the above paper and find it to be an excellent piece of work which could be very damaging to our business." The scientist suggested several ways to attack the study, but concluded, "I can find little to criticize. The authors have put together an excellent paper in my opinion." 1002641904-1907 (US 22933).

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a. ETS Research at Philip Morris's Institut für Biologische Forschung (INBIFO)

  1. Since 1971, Philip Morris has wholly owned a lab in Cologne, Germany, called

INBIFO, a German acronym for Institut für Biologische Forschung, or Institute for Biological

Research.

  1. In a February 24, 1970 memorandum from Philip Morris CEO Joseph Cullman to his

Vice President of Research & Development Helmut Wakeham, Cullman stated, "The possibility of getting answers to certain problems on a contractual basis in Europe appeals to me and I feel presents an opportunity that is relatively lacking in risk and unattractive repercussions in this country."

1000216742-6742A (US 35183).

  1. A May 7, 1970 memorandum from Philip Morris President Ross Millhiser to Cullman attached an April 15, 1970 memorandum from Wakeham recommending the INBIFO purchase.

Wakeham's recommendation included the following more candid assessment:

It has been confirmed to me . . . that TRW has definitely decided to sell INBIFO in Cologne, Germany. The asking price is about $190,000. . . .

Since we have a major program at INBIFO, and since this is a locale where we might do some of the things which we are reluctant to do in this country, I recommend that we acquire INBIFO. . . Mr. Hugh Cullman and Mr. John Murphy of Philip Morris International have offered their services in acquiring INBIFO so that its ownership would be achieved through some Swiss subsidiary of FTR [the Philip Morris subsidiary in Neuchatel, Switzerland]. In this way, our involvement would not be unduly exposed. On the other hand, International has stated a complete disinterest in operating INBIFO, and wish to leave that completely to the [Philip Morris] Research Department [in Richmond].

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  1. Wakeham's April 15, 1970 memorandum also included a chart listing the following advantages of owning INBIFO over simply contracting out the research.
  1. Better security - research projects and research results are more likely to be kept confidential. *** 7. Location near major airport in Germany makes access easy and obviates the necessity of doing controversial biological work in United States. *** 10. Records of work in Germany cannot readily be subpoenaed for use in the United States.

2012580900-0906 at 0904 (US 89328).

  1. In July, 1971, Philip Morris purchased INBIFO through FTR as Wakeman suggested. 2023226100-6118 (US 89415).

  2. In December 1972, Philip Morris hired Ragnar Rylander to serve as the company's intermediary and "representative at INBIFO." 2081912524-2525 (US 89358). Rylander reported to Philip Morris Research & Development in Richmond, with whom his contract was signed, while FTR approved and paid INBIFO bills. 2501368665-8668 (US 89327). A December 9, 1986 report by Reynolds scientist Charles Green recorded the following from a conversation with Thomas Osdene, Director of Research at Philip Morris, during a 14-hour flight to Tokyo: "Dr. Osdene is in charge of the INBIFO laboratory in Cologne. The managing director, $150K/year, reports directly to Osdene." 505491406-1410 at 1406 (US 50835).

  3. Philip Morris's Bob Seligman advised Philip Morris Europe's Max Hausermann in a letter dated March 31, 1977:

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As you were copied, you know that Helmut [Gaisch, of FTR] was requesting that we send samples directly to INBIFO. This suggested procedure is in direct conflict with our communications from the New York office. We have gone to great pains to eliminate any written contact with INBIFO, and I would like to maintain this structure.

Therefore, I am advising Jerry Osmalov to continue sending samples to Neuchatel [i.e., FTR] for transshipment to INBIFO. If this is unacceptable to you, perhaps we should consider a "dummy" mailing address in Köln [Cologne] for the receipt of samples.

2000512794-2795 (US 20295).

  1. Repeated experiments carried out by Philip Morris at INBIFO in the early 1980s were suggestive of adverse health effects associated with ETS. In a January 26, 1982 letter to Tom

Osdene in Richmond, Rylander reported the following:

Last week I visited with INBIFO. The results from the first side stream smoke experiment are available and confirm the previous observation that this smoke on equal TPM is more irritating and/or toxic. The histology demonstrates more advanced lesions in the nasal epithelium and hyper and metaplasia in areas which are not affected by main stream smoke. The extent of cornification observed in these animals has never been seen before.

1000081782-1783 (US 89174).

  1. Rylander had previously informed Shook, Hardy & Bacon attorney Don Hoel in

August 1981 that he was not "in a position to give 'environmental tobacco smoke' a clean bill of health." 680542957-2962 at 2958 (US 85718).

  1. Rylander also advised Osdene in his January 1982 letter that INBIFO was planning a series of new sidestream smoke studies utilizing two dose levels. 1000081782-1783 (US 89174).

  2. From the early 1980s onward, INBIFO ETS studies began generating results "strongly suggesting" increased harm incurred from passive smoke. A July 29, 1982 INBIFO report, titled

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"21-Day Smoke Inhalation Study with Mainstream and Sidestream Cigarette Smoke of Standard

Reference Cigarette Type 2R1 on Rats" recorded the following in the "Results" section:

  • The experiments used ETS-like smoke, namely "[d]iluted mainstream and sidestream smoke from puffed and nonpuffed cigarettes."
  • A number of "gas/vapor phase components were distinctly higher in diluted sidestream smoke than in diluted mainstream smoke: carbon monoxide (4 times), carbon dioxide (3 to 4 times), nitric oxide (6 to 7 times) and acetaldehyde (2 to 3 times)."
  • By and large, the rats of the sidestream groups reacted more vigorously than those of the mainstream group. All rats showed general signs of exhaustion after the end of the daily exposure. In contrast to the rats of the mainstream group, which recovered by the next morning, the rats of the sidestream group continued to show shaggy fur and some pronounced respiratory symptoms characterized by whistling and rattling sounds.
  • While the rats in the control group increased their body weight approximately 50% and those of the mainstream group increased their body weight 30%, the rats in the sidestream group "showed a decrease to approximately 80% of their initial body weight."
  • Rats in the sidestream group also showed a decrease in water consumption and body temperature as compared to the control and mainstream groups.
  • All of the examined sidestream-exposed rats showed slight to severe atrophic or necrotic lesions of the olfactory epithelium, in some cases together with reactive inflammation. The ciliated epithelium of all sidestream-exposed rats showed squamous-cell metaplasia, with cornification in some cases.
  • Exposure to diluted side- and mainstream produced histological changes in the nasal cavity and larynx.
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  • Generally spoken, sidestream exposure induced more frequent and more severe epithelial lesions in the olfactory and ciliated epithelium of the nasal cavity than mainstream of equal TPM concentration.
  • Sidestream smoke exposure invoked atrophy of the olfactory and metaplasia of the ciliated epithelium.

2029190329-0354 at 0335-0340 (US 89331).

  1. INBIFO scientists drew the following conclusions in their July 29, 1982 report of the inhalation study:

The systemic toxicity of mainstream and sidestream smoke impaired the body temperature, food and water uptake, body weight development and increased mortality . . . . Puffed and nonpuffed sidestream caused almost identical reactions, but the reaction to mainstream was much less pronounced than to sidestream exposure.

If one extrapolates from the experience of previous mainstream inhalation studies, the mainstream TPM concentration of this study would have to be increased by a factor of 3 to produce similar strong reactions [to those] seen with sidestream exposure in this study.

2029190329-0354 at 0344 (US 89331).

  1. The introductory section of the July 29, 1982 report, written by Ragnar Rylander, acknowledged that sidestream and mainstream cigarette smoke were "qualitatively similar" and that sidestream smoke condensate had "higher tumorigenic activity than mainstream condensate" in previous INBIFO skin-painting studies. 2029190329-0354 at 0331 (US 89331).

  2. Smoke condensate experiments at INBIFO continued to confirm that sidestream smoke was "more active" than mainstream smoke. In a July 6, 1984 INBIFO report, titled

"Comparison of 2R1 Mainstream and Sidestream Dry Impaction Cigarette Smoke Condensates, Base

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Fractions, and Neutral Fractions Activities in the Salmonella/Microsome Assay," scientists concluded that:

In [Salmonella strain] TA98, the specific activity of MS [mainstream] and SS [sidestream] CSC [cigarette smoke condensate] suggest that MS CSC may be slightly more active than SS CSC. The reverse was true for total activity, i.e., MS CSC was less active than SS CSC. In [Salmonella strain] TA100, MS CSC specific activity appears to be less than or equal to SS CSC specific activity; however, SS CSC total activity is greater that MS CSC total activity.

2501656104-6125 at 6123 (US 89335).

  1. Another study was carried out at INBIFO in 1985 to identify the "components causing biological effects of sidestream smoke." According to an INBIFO memorandum, the study results were presented to Philip Morris Incorporated scientist Robert Pages in November 1985 and included the following:

The last report gave you a survey of the irritative effects caused by inhalation of sidestream smoke (SS), such as reduced body weight development, histological changes in the respiratory tract, as well as biochemical changes.

In addition to the listed effects, SS causes a stimulation of the nerves. . . . Furthermore, this nervous stimulation causes a reduced CO2 [carbon dioxide] exhalation and a decrease of body temperature. The observed irritative effects of SS are relevant to humans exposed to SS.

In this context the most important question is: which SS-components are responsible for the irritative (biological) effects of SS. . . .

Our 1st starting point to clarify these questions came from previous inhalation studies which showed that the irritative activity of SS was nearly 4 times higher than that of mainstream smoke (MS), based on body weight development and histological changes in the nasal mucosa and the larynx. The comparison of the smoke composition of MS with SS shows that in SS the concentrations of aldehydes and

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ammonia are much higher than in MS. Therefore, it was supposed that these components are responsible for the irritative effects of SS.

2028986635-6654 at 6635-6636 (US 89330).

  1. Later in the presentation, Pages was told of the results of examinations of animals exposed to sidestream smoke. These results included atrophy of the olfactory epithelium (nasal cavity), "reserve cell hyperplasia of the respiratory epithelium," "squamous metaplasia of the respiratory epithelium," and hyperplasia and squamous metaplasia in the larynx/vocal cords. Pages was also told that these effects were "concentration-dependent." 2028986635-6654 at 6646, 6648 (US 89330).

  2. A 110-page report, titled "ETS-Related INBIFO Projects, Status: Dec. 94" is a summary of ETS-related work at INBIFO throughout the 1980s and 1990s, listing project names, dates of commission, a summary of the main results of each study, and an indication of whether the study was ever published. Very few INBIFO ETS studies were ever published. 2057077801-7911 (US 89333).

  3. The following is a small sample of the ETS-related inhalation, genotoxicity, and skin-painting projects summarized in the December 1994 INBIFO report. 2057077801-77911 (US 89333). According to the report, none of these projects were ever published. Project Date Objective Main Results Number 5223 7/22/91 Analyze fresh and room- "Data on cadmium and nitrosamines (page 7808) aged sidestream smoke for were generated. 24-h profile of

polycyclic aromatic several components in a smoke- hydrocarbons (PAH), filled room during ventilation nitrosamines, and heavy showed persistence of metals). formaldehyde, ammonia, and nicotine in the room."

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5228 8/02/91 Study of persistence of "TSNA [tobacco specific (page 7809) nicotine and n-nitrosamines nitrosamines] and nicotine are still absorbed on materials. detectable after 50 days.

2126 7/22/85 Determination of "PAH concentrations in the (page 7811) mainstream and sidestream condensates similar for both

smoke PAH in condensate cigarette types and both kinds of from test cigarettes. condensates (MS/SS); highest concentration found for phenanthrene."

3199 10/13/83 Comparison of the Sidestream smoke found (page 7832) cytotoxicity in human lung approximately three times more

cells using mainstream and cytotoxic than mainstream smoke. sidestream smoke from reference cigarette.

3113 11/27/84 Inhalation study of effects "In comparison to MS, SS caused a (page 7868) of diluted mainstream and greater reduction in body weight

sidestream smoke on the gain and in weight of thymus and rat respiratory tract. spleen as well as more pronounced histopathological changes in the nose and lungs. Only in the SS group atrophy and ulceration of the nasal olfactory epithelium were seen. Equally strong changes for MS and SS were seen in the trachea, and for SS less pronounced changes than for MS in the larynx."

3069 11/04/82 Inhalation study of effects "Lung: Foam cells in alveoli, (page 7889) of diluted mainstream and hyperplasia of bronchial epithelium;

sidestream smoke on the numerically higher incidence in SS- rat respiratory tract. exposed rats. Larynx: Increased thickness of laryngeal epithelium, MS: Squamous metaplasia without or with cornification; SS: basal-cell hyperplasia; changes in MS-exposed rats stronger than in SS-exposed rats."

3068 10/18/82 Tumorogenicity study of "Sidestream condensate showed a 2- (page 7897) mainstream and sidestream to 6-fold higher tumorigenicity than smoke condensate on mice. mainstream condensate."

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3070 11/10/82 Acute toxicity (mortality) "(SS = More Toxic)." (page 7898) study of mainstream and

sidestream condensate on mice.

  1. Philip Morris also knew that sidestream smoke effects were produced at very low concentrations. A 1994 written "short survey" of INBIFO ETS-related inhalation studies research, sent from INBIFO to Philip Morris, stated that INBIFO inhalation research showed:

In general, the biological activity of SS (e.g., respiratory tract irritancy and mouse skin tumorigenicity as well as in vitro cytotoxicity, mutagenicity, and clastogenicity) has been found to match or to slightly exceed that of mainstream smoke. . . .

In order to allow extrapolations to possible environmental concentrations of SS, lowest observable effect concentrations for various biological responses to fresh SS have been established in subchronic inhalation studies on rats and hamsters. . . .

Morphological changes (hyperplasia and metaplasia of airway epithelia) were detected in the rat larynx down to concentrations of 1 ug TPM/l. In the rat nose, hyperplasia was seen down to 6 ug TPM/l. . . . Biochemical changes, i.e., the induction of the aryl hydrocarbon monoxygenase, was observed down to 0.5 ug TPM/l in the lungs. . . .

Comparing the fresh and room-aged SS, the respiratory tract irritancy as well as the enzyme induction is mainly dependent on the total particulate matter concentration of the smoke regardless of the aging- related changes in the chemical composition.

2029221119-1120 (US 89417).

  1. In an undated 1984 document, Director of Science & Technology Tom Osdene listed the following steps to be taken with respect to INBIFO documents:

  2. Ship all documents to Cologne by Tom.

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  1. Keep in Cologne.

  2. OK to phone and telex (these will be destroyed) . . . .

  3. We will monitor in person every 2 - 3 months.

  1. If important letters or documents have to be sent, please send to home - I will act on them + destroy.
  1. Advise Rylander - when writing re INBIFO.

1000130803 (US 34424).

  1. In May 1986, Philip Morris barred INBIFO scientists from presenting findings of a sidestream and mainstream smoke condensate study and an inhalation study to an upcoming symposium in Essen, Germany. In a May 9, 1986 telex to INBIFO director Ulrich Hackenberg, Dr. Pages advised the following:

We have not yet reached a conclusion on what (if anything) could be presented. I should have something definitive to say by this time next week. . . .

We are having real problems with the presentation of the inhalation methodology in light of the fact that we almost assuredly [will] not authorize you to present any inhalation results. Thus the idea occurred to try to focus on SS CSC [sidestream cigarette smoke condensate] with an emphasis on comparison to MS SCS [mainstream cigarette smoke condensate]. Strictly in vitro results and/or analytical chemistry. That type of thinking prompts the above questions. This idea would not allow you to illustrate the INBIFO specialty, but it might be better than not presenting anything.

2501459834 (US 87035).

  1. In a memorandum dated May 20, 1986, Tom Osdene requested approval from management for the INBIFO scientists to present their smoke condensate results at the Essen symposium on ETS. The smoke inhalation studies were no longer under consideration in Osdene's memorandum. Osdene wrote the following in support of what he knew was still a controversial request:
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The principal reasons for allowing INBIFO to participate in the symposium are:

  1. I have discussed the three papers with Don Hoel of Shook, Hardy & Bacon and he feels that we would not be assuming a major risk in having this material presented by INBIFO.
  1. The presentation of these papers would be helpful to us on some aspects of the ETS issue. (Hoel also concurs with this view.)
  1. The presentations would be identified as coming only from INBIFO; there would be no mention of PM whatsoever. . .
  1. The subject matter of the presentations would be restricted solely to the collection, chemical analysis, and in vitro testing of sidestream (SS) cigarette smoke condensate (CSC) from the University of Kentucky Reference Research Cigarette. . . .

2001225907-5911 (US 87033).

  1. Philip Morris shared the adverse results of some of its INBIFO studies with other

Defendants. B&W's Gil Esterle recorded the following at the May 22, 1986 meeting of the Tobacco

Institute ETS Advisory Group:

Toxicity Testing. At the April meeting, Dr. Osdene (PM) requested delaying further discussions on the Deskin (RJR) proposal until May. Dr. Pages (PM) now reports that PM has had a toxicity project on ETS going on for three years in a Cologne, Germany laboratory. . . . Animals are whole body exposed to sidestream smoke greatly diluted with air. Exposure is carried out in a chamber in which diluted sidestream smoke is continuously fed while exhausting an equal volume of chamber air. Both rats and hamsters are being exposed. Animals are exposed seven hours/day for 21 consecutive days. . . .

At higher concentrations of particulate,20 There are conditions under which a ventilated cigarette yields higher tar and nicotine levels than those measured using the FTC method. See Section V(C)(2)(c)((2)), supra. -667- ug/m3 and 60 ug/m3, histological changes occur. The changes at 60 ug/m3 are greater than

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at 20 ug/m3. Changes are reversible with cessation of exposure. PM estimates that the diluted sidestream is about three times as active as mainstream smoke at some concentrations of particulate.

655042500-2503 at 2502 (US 22921*); 505347180-7186 at 7185 (US 85779); 504933596-3702 (US

24219).

  1. Philip Morris President and CEO Frank Resnik barred the INBIFO presentations. Dr. Pages wrote Dr. Hackenberg a May 28, 1986 telex informing him of the news:

Regret to inform you that we were unsuccessful in obtaining approval for INBIFO to present any of the proposed abstracts at the Norpoth Symposium. . . .

I want you to know that Tom [Osdene] personally discussed the abstracts with both Serrano and Resnik. We even wrote a short memo to put forth all of the reasons why it would be helpful and beneficial to have the papers presented. . . . Resnik was hesitant: he said he wanted to run it by the New York lawyers (Fred Newman). Newman said no. Resnik decided to go along with Newman and that was the end of that.

2501459823-9823 (US 87034).

  1. A December 2, 1993 memorandum written by Shook, Hardy & Bacon attorney Lee

Stanford recorded a conversation with fellow Shook, Hardy attorney Tony Andrade:

On November 30, 1993, I talked with Tony Andrade about records at INBIFO. . . . According to Tony, final reports on PM USA product research are sent to Richmond for a review and are then returned to INBIFO. Supporting data and documents are kept at INBIFO.

2043725390-5391 (US 20449).

  1. In a February, 1994 presentation by Franz Adlkofer, director of VdC (Verband, or

German manufacturers association) to an industry sidestream smoke meeting attended by representatives of Philip Morris, Reynolds, and BATCo, he said that his ninety-day study finding both dysplasia and metaplasia in exposed rats was not permitted to be extended to a longer-term study: "Dr. Adlkofer then told us that he wanted to do a two-year study in rats, but the industry would not support the study because they were afraid of the results." 508793116-3129 at 3117 (US 88577).

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  1. A 1990 Philip Morris memorandum written by Philip Morris Companies General Counsel Chuck Wall estimated that "INBIFO's work comes approximately 80% from PM-Richmond and 20% from FTR." 2023223372-3383 at 3383 (US 22337).

  2. Rylander himself wrote in a June 23, 1997 letter to Philip Morris's Richard Carchman: "I have never been involved with any Philip Morris executive in meetings or contacts with outside persons, to retain as far as possible the image of an independent scientist." 2063590609-0610 (US 85731).

  3. The November 1994 INBIFO Status Report reveals that the few studies that produced industry-favorable results were generally published. For example, the one published INBIFO short-term inhalation study found that all but one of the observed effects of ETS on the rat respiratory tract reversed completely during the post-inhalation period. Two studies finding that nicotine and particulate matter in fresh sidestream smoke were significantly reduced when the smoke aged and made contact with certain surfaces also resulted in a publication. 2057077801-7911 at 7810, 7884, 7908 (US 89333). Of the 106 studies identified in the 1994 Status Report, only four were published. Id.

  4. According to one record of this May 22, 1986 meeting of the TI ETS Advisory Group, Covington & Burling attorney John Rupp told the Advisory Group that ETS was the "Achilles heel of the industry." TIBU28843-8845 at 8845 (US 75440).

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b. Defendants' Recognition of the Validity of the Hirayama Study 3395. As noted earlier, in January 1981, Takeshi Hirayama published his epidemiological

study in the British Medical Journal showing a significant correlation between lung cancer and secondhand smoke based on his studies of 91,540 nonsmoking Japanese women. Hirayama showed that wives of heavy smokers had "a higher risk of developing lung cancer" and that "the effect of passive smoking was most striking in younger couples in agricultural families (ruling out the complication of urban air pollution), relative risk reaching 4.6, probably because of the lesser extent of the exposure to passive smoking outside the family in the case of rural residents." 2046342378- 2380 (US 22963).

  1. On or about June 14, 1981, the Tobacco Institute issued a press release claiming that professor Nathan Mantel had found a mathematical error in the Hirayama study that invalidated its conclusions. 03739919-9920 (US 22958). The Tobacco Institute media initiatives to discredit Hirayama -- including a press kit, press releases, and several letters from Tobacco Institute consultants, Tsokos and Kastenbaum -- were the subject of at least one Committee of Counsel meeting on June 24, 1981. ATX9275490311-0324 at 0316 (US 36232). A lengthy Tobacco Institute document summarizing the June/July initiatives reveals that Defendants' statisticians found a statistical error in the Hirayama study, that the Tobacco Institute and Burson-Marsteller publicized the error to the press, and that the error received widespread coverage in the national media. TITX0027702-7826 at 7707, 7803, 7814 (US 22332).

  2. In August 1981, the Tobacco Institute published an advertisement proclaiming: "Here's what's now being said about tobacco smoke in the air. . . . Scientist disputes findings of cancer risk to nonsmokers." In the ad, the Tobacco Institute declared that newspapers were reporting that "several eminent biostatisticians" had found a "statistical error" in Hirayama's calculations that raised "serious questions about the study." TIMN0019293-9293 (US 21575).

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  1. The Tobacco Institute knew, however, that the Hirayama data was correct and that the statistical error did not exist. In June 1981, industry consultant Peter Lee reviewed Hirayama's data and the Tobacco Institute statisticians' allegations. Lee concluded that the Tobacco Institute's claim of a statistical error in the study was "wrong and that Hirayama was right." 501622432-2433 (US 88150). RJR's Frank Colby wrote to general counsel Sam Witt on June 12, 1981 that Lee's conduct constituted an "act of extreme disloyalty." 501622432-2433 (US 88150).

  2. In early June 1981, both Lee and Mantel made it clear in writing to the Tobacco Institute that any error, even if an error existed, did not invalidate Hirayama's results. Lee wrote in a June 10, 1981 telex that:

Mantel's suspicions . . . are in my opinion definitely unfounded. Even if they were correct, T.I. should not quote Mantel as saying there is an arithmetical error which invalidates the claim of a high level of significance . . . I have talked to Mantel and he feels it probable that the best analysis methods would not significantly alter Hirayama's conclusions. . . . Please show this to T.I. and try to persuade them not to do the press release. If it is released and it is proved that Hirayama was not in error, they will be in danger of implicitly agreeing passive smoking causes lung cancer.

03029460-9461 (US 22830*).

  1. By July 15, 1981, Franz Adlkofer, Scientific Director of the German Verband, had reviewed Hirayama's data and, after discussions with Lee, also expressed internally his opinion that the Japanese study was accurate and that the Tobacco Institute had issued its press release despite knowing that the study was accurate. B&W in-house counsel Kendrick Wells summarized the events to Ernie Pepples, Senior Vice President and General Counsel at B&W, in a July 24, 1981 memorandum as follows:
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Dr. Adlkofer . . . has committed himself to the position that Lee and Hirayama are correct and Mantel and TI are wrong. Adlkofer called Frank Colby at Reynolds and said that Germany has received new data from Japan which confirms the Hirayama work. Adlkofer and Lee and another German associate were all asked to review Hirayama's work and did not find the error picked up by Kastenbaum. They believe that Hirayama is a good scientist and that his nonsmoking wives publication was correct. . . . [Adlkofer] replied with a strong statement that Hirayama was correct, that the TI knew it and that TI published its statement about Hirayama knowing that the work was correct."

2050987570-7571 at 7571 (US 22318); see also Rupp TT, 10/28/04, 4343:1-4346:6.

  1. The Tobacco Institute published its press release with the claim of a statistical error as part of a campaign that reached an estimated 56.7 million people by July 31, 1981. TITX0027702-7826 at 7707 (US 22332). In an advertising campaign that ran through October 1981, the Tobacco Institute continued to insist the study was flawed. TIMN0073499-3499 (US 77049). Reynolds was running a similar ad as late as 1984. 504100136-0136 (US 50882).

c. Other Internal Research and Statements Revealing Defendants' Knowledge of the Health Risks of Passive Smoking 3402. While Philip Morris used INBIFO to carry out the bulk of its ETS research, the

company also conducted a limited amount of internal research suggestive of adverse ETS health effects at its FTR affiliate in Neuchatel, Switzerland. 2057077653-7661 (US 66809). According to former Philip Morris scientist William Farone, Philip Morris initiated a study in 1985 code-named "Project Tasso" to determine the levels of tobacco-specific nitrosamines such as NNK (nicotinederived nitrosaminoketone) in sidestream smoke. Farone WD, 175:17-19. Tobacco-specific nitrosamines are known toxic substances generated by the smoking of tobacco, and are known components of secondhand smoke. Farone WD, 175:17-176:17; (US 17108); Samet WD, 171:15- 172:16.

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  1. The objective of Project Tasso was: