SHAMEFUL SCIENCE:

SHAMEFUL SCIENCE:

Four Decades of the Tobacco Industry’s Hidden Research on Smoking and Health

Norbert Hirschhorn, MD

Consultant to the World Health Organization

September 5, 1999

Introduction

I present here annotations of over 500 tobacco industry documents, along with much supporting material from other sources, that tell a four-decades’ story of the smoking and health research program sponsored by the members of the Association of Cigarette Industries of Germany ("Verband"). Its members include the German and Austrian cigarette manufacturers as well as the transnational firms of Philip Morris, R.J. Reynolds, and British American Tobacco.

The documents were found in three locations: 1) On the websites managed by the American tobacco companies at <http://www.tobaccoresolution.com> ; these are marked # .

2) On the website that holds the 39,000 OCR’d secret "attorney-client privilege" documents subpoenaed by the US Congress, at <http://www.tobaccodocuments.org> ; these are marked * . 3) The Minnesota Tobacco Document Depository. Explanatory material is marked [N.B.....].

The annotations are presented chronologically except for the first two, which give the background of the German research program and tell why American firms became involved.

Some relevant documents are still to be found. While nearly all the documents annotated here come from Philip Morris and RJR, a large cache of British American Tobacco documents on the Verband are held at the BAT Depository in Guildford, England, and have not yet been seen. Nonetheless, what is presented in the next 128 pages adequately tells the astonishing story of corrupt science in the service of a deeply flawed product. The selected quotations will astonish even those who have become inured to what has already been discovered, "in their own words."

Beyond the petty squabbles and unpleasant characters, the story can be boiled down to a few essential themes that thread themselves throughout the annotations.

The company scientists had to struggle with the accumulating and on-rushing evidence that theirs is one of the foulest products (in the environmental sense) sold to be taken into human bodies. That struggle was seldom openly or honestly fought.

Even as some of the scientists hoped, in vain, to create the "safer cigarette," company lawyers were focused entirely on avoiding litigation, and loss when sued. An army of public relations experts, front-organizations, and corrupted consultants served the lawyers, not the truth; the companies, not the public.

The German tobacco scientists, led by the wily Professor Franz X. Adlkofer, managed to integrate and ingratiate themselves with leading researchers, academics and government officials; even with some who were strongly anti-tobacco. This gave the German industry the prestige and time to carry out research, and the ability to influence policy not just in Germany but throughout Europe and other continents, even until today.

The German scientists knew from the start that the true battleground was, and still is, passive smoking. Their worry was not so much whether smoking caused disease – they knew early on it did – but they were obsessed by the evidence that tobacco poisons released into the air could affect the health of nonsmokers; and they did everything they could to deny, distort, suppress, and finally ignore the overwhelming evidence.

The documents

* 27 June 1980, Edwin Jacob of the law firm Jacob & Medinger, RJR 50468-1987-8,

504682009 - 2011, ""James K. Johnston Smoking Issues - Briefing Book."

The legal briefing for an incoming CEO gives the history and suggests the rationale for the American cigarette companies’ interest in funding and directing the research done by the Verband

The European tobacco industry’s approach to the smoking and health controversy has always been markedly different from the approach taken by the American industry. Several factors probably account for this difference. -- In the early 1950s, the American industry was run largely by people with an agricultural outlook, who were basically skeptical of the claims being made about smoking. In contrast, the European industry, particularly the English industry, was dominated in its consideration of the health issue by chemists and other scientists who often lacked a biological background. These industry scientists saw the statistical association, saw carcinogens in tobacco condensate and concluded that the smoking and lung cancer causation claim was scientifically established. The European industry took the position from the beginning that they had a bad product, and that attitude prevails today. The commencement of litigation in the United States in 1954 encouraged an already skeptical American industry to maintain, if scientifically defensible, the view that the case against smoking had not been proven. The litigation also required lawyers for the American industry to find eminent scientists, from many disciplines, who were of the opinion that smoking had not been scientifically established as a cause of lung cancer. When they were found, they were encouraged by consultation with their colleagues and by continued analysis and research to maintain their views. With the absence of lawsuits in Europe, the European industry seemed content not to contest vigorously the claims made against smoking.... Particularly in England, the industry found that the questioning of government policy and the like by the few scientists who disagreed and who were encouraged in research by the industry was an embarrassment.... As a result of the difference from the U.S. picture, the European industry did not establish organizations to fund independent scientists who could investigate whether or not smoking is a cause of human disease. Instead, industry laboratories were established by the English industry at Harrogate and by the German industry in Hamburg, seemingly in order to examine how smoking might operate in the causation of disease... After the Royal College of Physicians Report was published in 1962, the response of the English industry was muted, not vigorously opposing the later developing views that remedial steps should be taken. Ultimately, this led to various restrictions on advertising, etc.... As to the German industry’s institute, it developed over the years the problems that the American industry had anticipated with an industry laboratory. The Germans have established a research program to replace their Institute. Meanwhile, the English industry has sold its laboratory (Harrogate) to Hazelton, which is still carrying forward some industry-financed research.... Recently, the European picture has become clouded by growing recognition of the possibility that litigation problems, formerly reserved to the United States, might now crop up in Europe and elsewhere.

* 23 July 1992, memo, Charles R. Wall to Murray H. Bring (both PM counsels), PM 2022850392 - 0402, "Philip Morris Research."

Wall describes funding to various individuals and institutions around the world (see documents for these names). With respect to the Verband, Wall gives the rationale for supporting research in Germany:

I view with some concern the research effort in Germany. The Research Council operates much like the SAB [Scientific Advisory Board] of the CTR, and supports research based on grant applications. Much of the research focuses on nicotine.... The Research Council’s budget is approximately 2,500,000 DM, of which our share is $519,880. There is additional research funded by the industry outside of the Research Council, and that amount is budgeted in 1992 at approximately 2,900,000 DM, of which our share is $603,060. It is this latter research that I believe could be reduced without a significant downside to the industry.... Our scientists feel, however, that it is important to keep the research money in Germany, i.e., continue to support researchers in Germany even if we are not supporting them through the Verband.... The relationship between the industry and the German government seems to be a good deal better than the relationship between the industry and the government in this country. As I understand it, there are regular consultations between government and industry scientists, as well as constructive discussions regarding smoking-related laws and regulations. The industry in Germany appears to be more influential with the government than the industry in the U.S. and, for that reason, the industry feels it is important to maintain a substantial research presence. Although I do not believe litigation is imminent in Germany, should it occur, the fact that we are sponsoring research -- whether through the Verband, or individually -- could be of substantial help, in convincing a court that we are fulfilling our duty to conduct research. Nor do I think we should downplay the importance of having scientific contacts in as important a country as Germany..

[N.B. In 1975, the Verband closed its Research Institute laboratory, leasing the facility to the German Government for a nominal one DM a year. According to the 1980 BBC Panorama program exposing the practices of the British American Tobacco Company, Verband did so because the Institute’s Director, Professor W. Dontenwill, had demonstrated laryngeal cancer in hamsters inhaling cigarette smoke (W. Dontenwill, et al. Journal of the National Cancer Institute 1973, vol. 51, 1781-1832), and cardiovascular disease in pigs. According to Panorama, a secret Verband meeting pensioned off Dr. Dontenwill with 1.6 million DM, the equivalent of ten years salary. The Research Institute was replaced by an "independent" research funding agency supported by the German and transnational cigarette industry, with a Research Council used to approve research proposals coming from various scientists and institutions.]

# 1 April 1963, "Draft International Agreement on Exchange of Information... [between] the Tobacco Research Council on behalf of its member companies. and the Wissenschaftliche Forschungsstelle im Verband der Cigaretten-Industrie on behalf of its member companies," BAT (File no. B4908) 10536891 - 8919 (located in the Minnesota Tobacco Depository).

A contract on mutual information and cooperative research - a "gentleman’s agreement" to share results pointing to a cigarette less likely to cause cancer.

The Tobacco Research Council [UK] and the Wissenschaftliche Forschungsstelle agree by this contract to submit to each other without delay the following informations which have to include all technological details of manufacture. These are: 1. Information about modifications to cigarettes or other tobacco products which have been shown to be beneficial to human health. 2. Information about modifications to cigarettes or other tobacco products the smoke or smoke condensate of which have been shown to produce less biological activity to an extent that was statistically significant, a) in a test (or tests) of a type that was relevant for lung cancer or other human diseases....Both the Tobacco Research Council and the Wissenschaftliche Forschungsstelle respectively will endeavour to conclude equal contracts with AUSTRIA ABAKWERKE,Vienna...ADMINISTRAZIONE DEI MONOPOLI DI STATO, Rome...SERVICE D’EXPLOITATION INDUSTRIELLE DES TABACS ET DES ALLUMETTES, Paris...SVENSKA TOBAKS AKTIBOLAGET, Stockholm...VEREIGNIGTE TABAKFABRIKEN AG,Neuchatel.

[N.B. The first "gentlemen’s" agreement to share results leading to cigarettes causing less cancer. A 1983 memo by RJR Senior Scientist Alan Rodgman and Assoc. Director Frank Colby (17 December 1997, Deposition of Frank G. Colby "In The Matter of State of Minnesota, et al. V. Philip Morris, et al.," pages 54-5), "Smoking and Health Related Research Conducted by Philip Morris," relates that "Throughout the domestic industry, two gentlemen’s agreements operative in the early days," agreed that "any company discovering an innovation permitting the fabrication of an essentially safe cigarette would share the discovery with others in the industry;" and that "no domestic company would use intact animals in-house in biomedical research." This alone would have prompted the major transnational firms to look to the VdC to sponsor such research in Germany. * RJR 500877291 -7294, 6 December 1979, gives the statutes of the Research Council for Smoking and Health, its Secretariat, the Cigarette Industry Association and its Scientific Department. # PM 2001228258, circa 1970s, gives the organizational chart "Scientific Department of the Verband der Cigaretten-Industrie, directed by "Prof. Dr. med." Franz Adlkofer, with a Research Council for Smoking and Health and its Secretariat advising Prof. Adlkofer and the industry laboratory in Munich.]

# 21 May 1963, letter, from Loet Velmans, executive Vice President Hill & Knowlton International to Helmut Schanzer of Verband, RJR 501477795 - 7798.

Following closely on the April "gentlemen’s agreement" this is the first approach of an American public relations firm closely identified with the tobacco industry proposing to represent Verband and provide consultation, "with detailed suggestions on how to deal with the situation if and when the lung cancer controversy should become a major public issue in the Federal Republic." Hill & Knowlton work closely with Campbell-Johnson in England, another industry PR firm. Proposed consultants include Velmans (a former Dutch oil company consultant), Gerald Schroeder (German-born US citizen with ties to the 1948 presidential candidate Thomas E. Dewey)), Gerta Tzschaschel (German journalist with close ties to the Bonn Government).

# 26 August 1964, minutes, "Discussion at German Forschungstelle." BAT (File no. B1725 at Minnesota Depository) 105532610 - 2611.

Lists members of the committee running the Verband: Reemstsma, B.A.T., Brinkmann, Neuerberg, and a representative of smaller manufacturers. "The first four members have 98% of the cigarette trade." Clearly, BAT is the only multinational member at this time through its German subsidiary. "The informal agreement between the German cigarette manufacturers to restrict advertising expenditure had recently been brought up to date and was still in operation."

* 13 August 1965, RJR 503272396, "Abstract of Scientific literature."

Earliest mention in industry papers turned over to Minnesota of research done at the Verband laboratory dealing with animals made to inhale cigarette smoke and the tumors produced.

* 19 July 1966, trip report, R.B. Griffith (Brown and Williamson researcher) to A. Yeaman (B&W in-house counsel), RJR 680204107 - 4114.

Describes visits to Industry laboratories in England, Sweden, Germany, France. The comments on the German industry labs reveal at this early date the rationale behind "smoking and health" research done by the tobacco companies, more for public relations and political advantage than for preventing disease.

[The Germans] have apparently convinced their Minister of Health that they know more about smoking and health than anyone else, that they are taking responsible actions, and he apparently turns to them for advice. The German companies seem to be working closely together, and have decided that no one can afford the luxury of a temporary competitive advantage in the smoking and health area. BAT, for example, has company-supported research which shows that "KRONE" [sp?], their newest brand, has 50% of the biological activity of other brands (based on mouse skin painting). They will not advertize this under any circumstance and presumably will make the processes used available to others when they are certain there is a health significance. They do not consider that they are in a vulnerable position because they are conducting mouse skin painting tests, but rather consider that this was essential in establishing their position with their Minister of Health. I consider the German industry to be in a better position than the industry of any other country, and hope that the U.S. industry can move in that direction.

* 15 January 1969, K. Caroll to M. Crohn, RJR 50381- 4318, "Inhalation experiments with cigarette smoke."

Cites Verband abstract of experiments with golden hamsters:

Long-term cigarettes smoke exposure in hamsters led only occasionally to tracheal papillomas and not to squamous cancer. However, one could sensitize these animals with diethylnitrosamine and enhance the tumor production initiated by this carcinogen by a variety of volatile irritants including tobacco smoke. [N.B. Nitrosamines are a product of burning tobacco, related to the nitrate content of processed leaf, and potent carcinogens.]

# 1971, "Smoking and Health...Comments of the VdC (Association of Cigarettes Manufacturers) released to the members of The Subcommittee on the Food Law Reform," , RJR 504834531 - 4532 (only title and first page available).

An early acknowledgment that smoking causes cancer, but with the implied belief that modern cigarettes with filters and lower tar might not be the same as smoked previously.

The cigarette industry does not dispute that statistical studies conducted mainly in the 1950's in the United States pointed up statistical relationships between cigarette smoking and lung cancer. It feels compelled, however, to state the following. Scientists agree that the latency period between cigarette smoking and the development of the disease amounts to several decades. Professor Schmael of the German Cancer Research Institute of Heidelberg set the latency period at 30 to 40 years. This means that findings obtained today must be attributed to a cigarette consumption that goes back over several decades. The cigarettes on the market today in Germany, at any rate, can no longer be compared in any way....

# 4 October 1974, Paul Isenring to various Philip Morris staff and affiliates including Donald Hoel, Shook Hardy & Bacon counsel to ICOSI (International Committee on Smoking Issues, an industry-sponsored public relations institute), "Germany ‘Verband’." PM 1003727787 - 7790.

New German food law, if rigorously applied, could create advertising ban on tobacco "plus education programs to curb down cigarette consumption." Public Health Minister objected to Reemtsma’s new nicotine-free cigarette. With the industry being attacked, Verband needed much more "scientific material" on smoking and health, particularly as the French Monopoly claimed their darker cigarettes were healthier than the "light" German cigarettes (fewer smoke, less inhalation). Verband sees necessity to disprove the claim, and also to produce "safer" cigarette.

* 18 July 1975, Don Hoel (Counsel, Shook, Hardy and Bacon) memo to A. Holtzman (Philip Morris), PM 2024964938.

"A recent television program [in Germany] described smoking as ‘the most important single risk factor’ in cardiovascular disease causation.... Additionally, the contacts of the Verband with the Health Ministry are diminishing because of the influx of anti-smoking crusaders in that agency." Further bad news was the possibility that Reemstma, the only wholly German-owned company might leave the voluntary advertising code of the Verband, which could cause a "blowup" of the Verband, and the imminent dissolution of the Verband’s Research Institute with the "golden handshake" to its Director Dontenwill who found laryngeal cancers in hamsters exposed to smoke.

* 24 July 1975, Frank Colby letter to Wilfried Dembach (RJR lawyer in Cologne, Germany), RJR 500259565 and 500259421.

Colby offers to keep Dembach abreast of all the research on health and smoking, published or not. Those not in the public domain "may, please, not be quoted in any shape or form."

[N.B. Frank Colby, a chemist, was RJR’s manager/director of research and scientific information from 1951 to 1979; associate director of scientific issues from 1979-1983; a consultant working out of the Jacob & Medinger law firm, which represented RJR, for some years after. He was a refugee from Nazi Germany, got his doctorate at the University of Geneva, Switzerland. Colby’s position description with RJR states under "principal accountabilities, first "Efficiently provide the technical expertise necessary for the Company to combat anti-tobacco claims." 17 December 1997, Deposition of Frank G. Colby "In The Matter of State of Minnesota, et al. V. Philip Morris, et al.," page 67.]

# July 1975, no author, translated from the German, "Germany -- ‘Verband’. Reflections towards PR-work of the Cigarette Industry." PM 1000219760 - 9768.

Increasing attacks on the cigarette industry, supported by the Federal Health Ministry. The Verband was not prepared to respond to the attacks. Author suggests that an "information service" be created to influence the media, medical community, health authorities, etc., which would be incorporated in the USA (the "International Tobacco Science Information" [perhaps ICOSI - International Council on Smoking Issues] to serve in different countries. In Germany, Dr Kirch (pro-tobacco medical author of "The Cigarette") would be editor of a newsletter published by RAU-publishers in Dusseldorf. Verband and the US Tobacco Institute would supply the basic information. A brief booklet for smokers and tobacco industry workers would deal with "anti- tobacco propaganda." "Like for all other stimulants and food -- it is the exaggeration which can be harmful." Assertion of hazards from passive smoking is "an exceptionally effective ‘weapon’" in the hands of anti-tobacco forces, and needs to be countered. News releases, smokers’ newsletter, etc. to be distributed through tobacconists shops (750,000 copies).

# 24 October 1975, Paul Isenring (Philip Morris) speech to Managing Committee of Verband,

"‘Smoking and Health’ --The Industry Policy Today and in the Future." PM 2024965269 - 5271.

With anti-tobacco movement becoming more active in Europe ("Everywhere, there are heavy tax increases, in various countries based on the ‘Smoking and Health’ issue."), led by WHO, the response from the European and German industry has been "silence," as each company seeks only market shares, not a common, industry-wide policy. In particular, German manufacture of "lighter and lighter cigarettes...low in nicotine in smoke or nicotine free.... Do we really want to dig our own grave in this manner." The threat is the destruction of the Tobacco Industry, prohibition of smoking. The important questions to be answered are:

1) Can the Industry, in Germany and in Europe, continue to keep silence or is it ready to work out a new policy which should consist in bring the fact of the scientific controversy with regard to "Smoking and Health" and to the importance of the industry in general, to the knowledge of the public, government, parliament?

2) In this context, the product policy regarding the low in nicotine smoke cigarettes and the nicotine free cigarettes may be reconsidered. This would be in the highest interest of the smokers -- our customers -- and therewith of our industry.

# 5 November 1975, minutes of discussion following Isenring’s presentation,

"Re: PR activity and "Smoking and Health."PM 2024965211 - 5217.

Discussants agree a public relations activity is needed (along the lines of the 18 July 1975 proposal), at least to counter the statistics published by the Federal Government on 140,000 smoking-related deaths a year, and "DM 20 milliards as cost for social consequences." Discussants were exercised about possible prohibition of smoking at work places, "especially dangerous as the sales would be severely affected through such a measure." Chairman of the meeting, Mr. Dieter von Specht (of the BAT Cigarettenfabriken GmbH), suggested a Research Council be established to recommend to the German Industry what research should be funded. Despite the warnings by Isenring and PM/ Switzerland’s Helmut Gaisch, von Specht declared that "The objective of the Research Council should be to support projects from which positive indications regarding a ‘safer cigarette’ could be expected." Another point of contention was the Verband’s desire to include Ernst Wynder (developer of the mouse-skin cancer assay and one of the early scientists to link smoking to lung cancer) on the Research Council. PM objected.

* 24 February 1976, Colby Memo for the Record, "Conversation with Dr. Koenig of the Verband in Hamburg." RJR 500293555 - 3556. [N.B. Harold Koenig was the Chief Administrative Officer of the Verband laboratory.]

Discussing a two-day symposium, the first to be dedicated to "biased" research, the second to the beneficial effects of smoking. "Even though I did not discuss this with Dr. Koenig, the obvious danger there to me could be a new emphasis on low tar and nicotine."

* 28 April 1976, memo, Colby to H.D. Rickert (RJR in-house counsel), "Spengler contract," RJR 502741260.

As you may know, Ed [Jacob], Tim {Finnegan] [both of Jacob, Medinger & Finnegan] and myself prepared a lengthy document commenting on the research projects which are planned on behalf of the German Cigarette Industry, some of which are clearly detrimental.

* 4 August 1976, letter, Colby to Dembach, RJR 510715323.

Sends along comments by RJR scientists on some particular research protocol ostensibly from the Verband: "This is of course a purely scientific evaluation which may or may not be overriden by political considerations."

# 17 November 1976, Paul Isenring memo to several persons, "Germany -- Verband -- Research project. Beneficial Effects of Smoking." PM 1002610069.

Isenring want s Verband to contact the Tobacco Institute, BAT-Germany, Philip Morris-Germany to coordinate with their US-based companies. Philip Morris could consider such a project and its approach.

# Circa 1976, Verband’s public relations plan, RJR 500257486 - 7487.

Shows early entry of Verband into the PR field, unrelated to tobacco research. Items include the following aims: "Proving the scientific irrelevance of the thesis that passive smoking damages the health of the non-smoker.... Outlining the benefits of smoking; reassuring the smokers of their habit....Ridiculing the lunatics of the anti-smoking-league....Furthering the image of smoking as a desirable social habit." Techniques include direct mailings, approaches to media, government, medical groups.

* 26 April 1977, memo from Colby to Edwin Jacob (Jacob & Medinger Law Firm), a hand-written translation from the German by Colby of the first two pages of a 20+ page Verband position paper on Smoking and Health. RJR 500269280 - 9281.

The topics listed are: "Basic position of the [German] Cigarette Industry. Problem of ‘passive smoking.’ The development of cigarettes offered in the German market. Reduction of condensate, gas phase, and plant protection agents. Does smoking of mild cigarettes lead to higher consumption? Advertising of tobacco products: Voluntary restrictions of advertising by the German Cigarette Industry. Warning labels on packages. The cigarette as entrance to drugs?"

The first chapter is translated:

The cigarette industry does not dispute the point that statistical studies conducted in the United States in the fifties indicate a statistical correlation between cigarette smoking and lung cancer. The cigarette industry also does not deny that tobacco smoke contains carcinogenic substances. However, animal experiments conducted in independent institutions throughout the world have shown that we are dealing here with relatively weak carcinogens. As a result, only very large doses of smoke condensate or tobacco smoke seemed to produce tumors on a small number of experimental animals. The doses were so large that, if conclusions from animal experiments can be transferred to man, they would correspond to completely unrealistic number of cigarettes.

* 3 June [probably in 1977], Colby letter to Dieter von Specht (BAT Germany), "Re: Verband (Adlkofer) Nicotine Research Concept." RJR 500281851 - 1853.

Colby presents numerous arguments, based on considerations of scientific experimental design, why Franz Adlkofer (Medical Research Director of the Verband-funded laboratory) should abandon plans to study nicotine effects on animals through inhalation. Colby notes that lawyers Ed Jacob and Wilfried Dembach had already spoken with Adlkofer on the subject. Adverse findings from such experiments might be used by "our adversaries." This relates to the threat that the FDA might regulate tobacco if claims were made on the benefits of nicotine, thus all such research should stop.

* 22 June 1977, Colby memo to the record, RJR 502740064.

Colby decides not to provide additional funds to Verband, "We have been in disagreement with the whole program altogether." Hopes to influence Philip Morris Europe to follow suit.

* 1 July 1977, Colby "Unedited Draft Notes," "Some Thoughts On Selected Highlights of an Information System for the Verband der Deutschen Cigaretten Industrie Purpose." RJR 500273956 - 3958.

Colby notes are clearly meant to be addressed to the German tobacco industry, offering to build a scientific library in Germany similar to what he had built in the USA. He hopes other European manufacturers would help subsidize the effort. The purpose includes having appropriate literature to respond to attacks on the German cigarette industry in the area of smoking and health, but also to help the Research Council ("Forschungsrat") evaluate research proposals, and to be abreast of cigarette technology and additives.

# 8 July 1977, Colby trip Report Notes, RJR 511074355 - 4357.

Colby uses a "confidant" within Verband to try convince Dieter von Specht "to affect the policies of the Verband regarding smoking and health.... to achieve a less compliant attitude toward the Government and anti-tobacco medical establishments in Germany." He also obliquely criticizes continued support to Ernst Wynder to study bladder cancer [presumably as a result of smoking], Verband support of research on nicotine as a co-carcinogen, and on smokers’ "compensation" [when smoking light cigarettes].

* 29 July 1977, Colby report, "Report on trip to Europe, October 1976. 1. Project on the psychosomatic aspects of lung cancer. Prof. Dr. Blohmke, Dr. Baltrusch, Mr. Jacob." RJR 500949347 - 9348.

This reports seems to set the structure for RJR overseas funding of research. It would not involve Americans, funding would come through RJR’s legal representatives but kept a secret.

The general conditions for the research grants were mentioned to them.... [among others] that specifically no US researchers would be involved.... I assured them that there would be complete freedom of publication but that we would reserve ourselves the right of vetoing any mentioning of the financial support received from Haus Neuerburg.

* 14 September 1977, memo, Colby to H.C. Roemer (RJR counsel), "Blohmke project," RJR 504312107.

One of the first indications of American tobacco companies’ intentions to ship tobacco research on smoking and health overseas, with strict control over the work shared by RJR’s German counsel and US-based scientists who reported to home-office counsel and U.S. law firms.

In my judgment, it is desirable to send a substantial amount of money to R.J. Reynolds Tobacco, GmbH, Germany, in order for them to have funds available for the Blohmke project.... Wilfried Dembach has suggested that a formal letter be sent to him and he has proposed the following draft: "Our Company is interested in doing [hand-stricken, substituted with "the support of"] medical research outside the United States. With regard to the funds [hand-written insert: "for research in Germany"] we provide you with the necessary financial means up to an annual budget of U.S. dollar 250,000.00. The projects themselves should be handled by yourself on behalf of R.J. Reynolds Tobacco GmbH, Germany. All details, especially the issue of the research and the scientists, shall only be determined after our expressed approval. [N.B. The "Blohmke Project" was research into the psychosomatic origins of lung cancer.]

* Approximately September 1977, Colby draft report to W. Dembach, RJR 502741197 - 1200.

Colby is concerned about several persons the Verband will appoint to the newly established German Tobacco Research Council. He is dead-set against a Prof. Schettler:

...not a good scientist...his endorsement of margarine and the financial support he has enjoyed from the German margarine industry...endorsing some cardiovascular drugs without scientific justification but because he was ‘subsidized’ by the firm marketing such drugs...Schettler is vehemently anti-tobacco and interprets and often distorts any data in a manner which is as anti-smoking as possible.

Colby also against a Dr. Valentin because it came out that he was being financed by the tobacco industry when he spoke against bans on public smoking, although he had denied such payments at the time - it would provide ammunition to adversaries. Further, Dr. Adlkofer "has consistently shown poor judgment regarding scientific matters." Especially as the new arrangement of Verband, the Research Council will be for Adlkofer to "dream up" the projects and the Council to "consent." Colby insists RJR withhold financial support under such an arrangement. Colby feels it is unethical to pay Ernst Wynder to be on the Council.

Wynder is totally and uncompromisingly opposed to smoking and his advocacy of the ‘less harmful cigarette’ is only an intermediate step to weaning the smoker totally. The only ‘useful’ result which could come from such payments would be him reiterating his statements that the German cigarettes are the lightest cigarettes on the world market.

Colby finally insists that Verband give "firms, including, of course, RJR three months in which to approve a research project as per prior agreement."

* 2 November 1977, letter, Alan Rodgman (RJR senior scientist) to Dembach (RJR German counsel), RJR 515972148 - 2152.

Rodgman objects to Verband spending money to research phosgene (a chemical resulting from freon expansion of tobacco leaf, which bulked up and therefore lessened the amount of tobacco used per cigarette) in tobacco smoke. He provides the Dontenwill data on hamsters exposed to cigarette smoke (twice a day for 120 weeks) with and without phosgene and shows freon-untreated tobacco seemed to reduce tumors in the hamster larynx by about a third. Here we see in an industry document the Dontenwill data that may have led to his involuntary and premature retirement: Comparing expanded to control tobacco, 22% and 34% of hamsters, respectively, had either cancer or benign papillomas with 10% and 6% having actual malignant cancer.

* 29 November 1977, Colby memo to RJR in-house counsel H Roemer, "Contact with the German Cigarette Trade Association." RJR 503247230 - 7240.

Comments on his discussion with Franz Adlkofer (scientific director of the Verband- funded research laboratory) that while Adlkofer had "the ability to understand the scientific realities and the political background of the smoking and health controversy.... However, unfortunately, his convictions do not seem to last, and he is swayed easily and will not always stand up for his convictions." Notes that Wynder’s bladder cancer proposal was turned down "because R.J. Reynolds-Germany had protested against it."

# 20 December 1977, Helmut Gaisch (Philip Morris International) letter to Herbert Bentley (Imperial Tobacco Co. - a BAT subsidiary), RJR 500298998 - 8999.

Curious to find a PM letter to Imperial in the RJR files. Gaisch complains about Verband’s independent ways. The letter and attached Colby aide-memoire also shows how the principal members of the tobacco industry tried to suppress research that might throw bad light on their product; or lead to standard measurements that, perhaps, could lead to regulation; and only condoning experiments to discredit results negative for the industry. Ironically, standard FTC measurements of mainstream smoke tar and nicotine are strongly defended by the industry in contrast to the more realistic measurements under real-conditions of smoking.

Last week on 15^th and 16^th of December, scientific meetings took place at the headquarters of the German Verband in Hamburg on the subject of passive smoking. I had delegated Dr. Fink of our laboratory on behalf of Philip Morris Germany. He had been briefed by me to follow the policies outlined by I.C.O.S.I. [International Council on Smoking Issues, an industry information and PR organization]. In particular, I had drawn his attention to the fact that it had been found by I.C.O.S.I. not to be in the interests of the industry to experiment to much with sidestream smoke as this could lead to the development of standard methods for sidestream smoke determination, something we would like to avoid at all costs because it is scientifically nonsense. Instead we would like to deepen as quickly as possible our knowledge as to the measurement of ambient smoke under realistic conditions.... As it turned out, some company scientists present at the Hamburg meeting did not seem to feel bound by the I.C.O.S.I. view. I very strongly feel that we must make sure that the objectives of I.C.O.S.I. are followed by company scientists, otherwise we risk detrimental effects for industry.... The German Verband has, in any case, a tendency of going their own peculiar ways.

Appended to the letter is a memo note from Colby date 4 January 1978:

I telephoned Dr. Gaisch on January 3^rd, explaining to him that I had rectified matters with the Verband during my visit with them on December 16^th, 1977, and that we had come to a tentative understanding: a)that they would not do any testing of sidestream smoke, such as developing standardized conditions, etc., except as stated under (b). B) That the only work which would be commissioned by the Verband would be to re-run all the experiments and only the experiments described in the Brunneman/Hoffman papers, to determine whether the values were accurate. c) It was understood that, subject to agreement by ICOSI Committees, etc., any measurements of environmental nitrosamines under real life conditions (as opposed to Neurath, etc. sidestream collecting device), would be carried out via ICOSI.

* 21 February 1978, Colby memo to Roemer, "Excerpts of minutes from the latest meeting of the P.R. Committee of the...Verband." RJR 50028-0674.

Verband P.R. Committee warns about the impending referendum in California to curtail public smoking. "It is also important not to underestimate its potential opinion-molding effects on the German public."

* 15 March 1978, S.B. Witt (RJR in-house Counsel) letter to Hume Stewart-Moore(Chairman, Gallaher, Ltd.), RJR 50233-0421.

This memo shows the interesting connectedness of German researchers who were looking to show carcinogens in cigarettes (and thus try make their removal possible) with the Verband. One of Ernst Wynder’s colleagues, Dietrich Hoffman, had published data in the 1960s with Wynder showing the tumorigenic effects of cigarette smoke. In the late 1970s he was working on nitrosamines, but also writing a position paper for Verband on passive smoking. The international companies kept doing their best to limit any damage German researchers could do.

I understand that an accommodation has been reached between the German association (Verband) and Dr. Hoffman which will be incorporated in a redraft of the Position Paper on Public Smoking; essentially it will acknowledge that from a scientific standpoint Dr. Hoffman’s work is not relevant.... Finally, we heard during the course of the session on Friday that Philip Morris has done some work essentially aimed at ‘discrediting,’ if that is not too strong a word, the methodology used by Dr. Hoffman.

* 22 March 1978, letter from Colby to Edwin Jacob of Jacob & Medinger,

"RE: Nitrosamines and sidestream smoke/Germany." RJR 500281911.

Colby objects to continued Verband funding of Dr. Dietrich Hoffman ("of the Wynder group") whose research on second-hand smoke was "not obtained under real life conditions," and whose "unrealistic data will be quoted against us." Adlkofer promises Hoffman will separately and personally present his future proposals to the German Industry scientists, with Colby in attendance.

* 29 March 1978, memo to file, S.B. Witt, RJR 500549438 and 500549441.

Discussion of national research and role of ICOSI to set up standards for measurement of smoke constituents, and to report out research favorable to the industry.

At the outset, Dr. [Herbert] Bentley [Imperial Tobacco/UK] announced himself in favor of "staying close to national associations to make sure they don’t embark on research which might be embarrassing for us," which was music to our ears.... Spengler mentioned the work of Dr. Hoffman in Germany [on nitrosamines], and the work of the Verband to disprove his theories. PME is also doing research to discredit Hoffman’s theories, and has offered to make it available to ICOSI.

# 29 March 1978, Philip Morris’s Paul Isenring memo to "Hoffman", PM 2501025100, "ICOSI-Public Smoking Paper."

Urges coordination and a "modus vivendi" between the two principal law firms representing the industry, Jacob & Medinger (RJR) and Shook, Hardy & Bacon (Philip Morris, Tobacco Institute and other US tobacco companies), and their involvement in European issues.

* 30 March 1978, Colby memo to RJR in-house counsel Samuel B. Witt, "ICOSI Working Group of the EC." RJR 50094-4076.

Colby advises Witt that an ICOSI [International Council on Smoking Issues] be explicit about why cigarette companies are producing low tar and nicotine cigarettes - a matter of competition, not to promise health benefits. If the German Industry does not change its "basic attitude," Colby suggests strongly that RJR-Germany resign from the Verband.

* 21 April 1978, memorandum from P. Isenring to CD Durden, on ICOSI - EEC Task Force on Consumerism, PM 2501025098.

A response is needed to an EEC paper, "The Tobacco and the Health of the Consumer."

It will require working from an industry paper previously submitted to the EEC on public smoking, drafted by the law firm of Jacob & Medinger, and that the Verband should lend its materials.

* 1 June 1978, Colby memo to Senior RJR Scientist Alan Rodgman, "Information for Dr. Laurene’s weekly meeting with Mr. Hobbs." RJR 500885524.

Alerts Rodgman to "Some potentially forthcoming changes in the smoking and health research policies of the German Cigarette Manufacturers Trade Association (Verband)," discussed with lawyers Dembach and Jacob.

* 19 June 1978, Colby memo to RJR in-house counsel R.C. Roemer, RJR 500280584.

Wants himself and Ed Jacob to speak to Verband before they actually make the changes in their research policies.

* 17 July 1978, Colby letter to Wilfried Dembach (RJR-Germany counsel), RJR 50028-1041.

I am planning to start a major file for future reference documenting the thesis that advertising does not sell cigarettes, but sells merely switching from one brand to another. Please send me all the material you have on this topic.... include whatever material may be available from the Verband. [N.B. First indication of Colby moving off from his expertise as a chemist and scientist.]

* 28 July 1978, abstract of publication, in German, from the Verband, "NOT TO BE GIVEN OUT WITHOUT FGC O.K.", "Some Definitions on the alleged carcinogenic and co-carcinogenic effects of tobacco smoke condensate." RJR 510826747 - 6748.

Definitions include primary carcinogens such as benzo(a) pyrene, tumor-initiators or promoters such as dibenzanthracene and phenol, co-carcinogens that with another substance accelerate formation of tumors such as catechin. Anonymous author notes that no mechanism is known to distinguish a promoter from a co-carcinogen.

* 3 August 1978, Colby memo to D.R. Piel, "Information for Dr. Laurene’s

weekly meeting with Mr. Hobbs." RJR 500885513.

At the confidential request of the German Cigarette Manufacturers Association, I have drafted a "Letter to the Editor" on behalf of a German scientist associated with the Verband responding to the recent paper by Aronow on passive smoking. Some informative material was sent to the Verband and other measures were undertaken in order to prevent them from organizing a symposium on carbon monoxide, which has a potentially damaging effect on our Industry.

* 17 August 1978, memo from Colby to H Roemer (RJR in-house counsel), copies to outside legal counsels (Hoel, Jacob, Witt), "PR Committee Meeting Minutes -- Germany." RJR 500280787.

Quotes Adlkofer’s views on smoking and health controversy:

In considering the more recent publications of mortality statistics on lung cancer and heart attacks in the U.S.A., Great Britain and West Germany, as well as the studies by Hammond, Wald, and Wynder, one can come to the conclusion that the mild cigarette is not necessarily the answer, as frequently asserted, to the health risks related to smoking. Dr. Adlkofer’s viewpoint much indicates a notion that a cigarette with a relatively high nicotine content and a low condensate content [i.e., tar] is the cigarette of the future.

# 31 August 1978, Colby memo to Alan Rodgman, "Information for Dr. Laurene’s weekly meeting with Mr. Hobbs." RJR 500885509.

Comments on British Hunter Committee (Independent Scientific Committee on Smoking and Health) Report, its second on smoking and health, likely to be as critical of tobacco as the first, and urging Government regulation. Discusses "unpublished Wynder data" on alleged paradoxical epidemiological findings on smoking and cardiovascular disease, discussed with Dr. [Gary] Huber and the Verband.

# 1 September 1978, Colby memo to H.C. Roemer, "German ‘Compensation’ Study." RJR 503647069.

The study under Verband sponsorship will not be supported by RJR-Germany. Colby, Jacob, Dembach will discuss this study as "one of the topics" in the upcoming September 11 meeting with Verband’s Drs Koenig and Adlkofer.

* 28 September 1978, Colby report to H. Roemer, "Discussions with the Verband." RJR 503240579 - 0582.

Colby strongly discourages Verband from any research on nicotine and compensation. "I consider the nicotine oriented research concept and the planned research derived therefrom to be totally worthless." Colby is particularly incensed by the concept of "compensation" to increase nicotine intake, when at the same time the Verband has given up researching the beneficial effects of nicotine. "...at worst, only a small minority of smokers are adversely affected [by smoking]....

All the other cigarette companies have reversed themselves and have now decided not to participate in the compensation study."

Colby seeks to besmirch the reputation of a cancer specialist, one whose research cast a negative light on cigarettes:

I obtained some information from a reliable source that the head of the current German Industry Finance Research Council on Smoking and Health, i.e. Prof. Schmaehl, a widely known expert in chemical carcinogenesis, has and is receiving financial kickbacks from some of the current research grantees of the (Verband financed) German Tobacco Research Council. I was also informed that these were kickbacks for personal use and not some possibly defensible contribution towards Prof. Schmaehl’s own research projects.... From still another source, I was informed that indeed Prof. Schmaehl is ‘in great financial need’.

* September 1978, Colby to Roemer, RJR 503240499 - 0502.

Concern about leakage of scientific information, connections between scientists from different companies and countries, tied to fear of litigation in the USA. "In a US law case...foreign files may not be immune to subpoena.... We then discussed a potential future mechanism for how to control undesirable contacts by ICOSI member companies or national trade associations from one country with scientists from other countries and how to develop such a mechanism without jeopardizing our German companies funded research contacts." [N.B. Colby wrote "contacts," not "contracts."]

* 3 October 1978, Colby memo to H. C. Roemer, "German Claims Alleging Filter Cigarettes Allegedly Less Safe Than Regular Cigarettes." RJR 501790036.

I have just been informed that a sensationalist type German magazine called "Quick", has published an interview with Prof. Schettler of Heidelberg University. In this interview Prof. Schettler alleges that smoking is the most "important" risk factor in cardiovascular diseases. He also alleges that the newer filter cigarettes are not "safe" either, but are, in effect, less so than the regular old style cigarettes.... One of the most noticeable facts about this story is that Prof. Schettler is the second most important research grantee (after Dr. Wynder) of the German Verband. I had tried unsuccessfully for years, repeatedly, to convince the German Industry that Prof. Schettler was a person not to be trusted and had even given them some information about some questionable dealings he allegedly has been involved in with the German drug industry. I also warned them that he was using the cigarette Industry as a scape-goat to bolster his integrity. The fact of being able to say "I told you so" provides slim satisfaction if weighed against the unfavorable effect such a blast must have on the German Industry as a whole.

* 5 October 1978, Colby report H.C. Roemer, "Discussions with the Verband on their suggested nicotine research concepts." RJR 503247193, 503247196, 503247198, 503247200 - 7210.

Colby comments on recruiting German scientists to do tobacco research: About a Doctor Dieter Neubert (who wanted to research the effects of tobacco on fetuses), "When we first saw him, there was no possibility to ‘investigate’ him, but since that time a literature search of him has been made and no adverse statements on smoking have been uncovered to date."

Colby continues:

It has been extremely difficult in the past to recruit the above discussed German research grantees and reading hundreds of papers published by them. Even for each of the research grantees it took several persistent contacts before they showed enough confidence in the seriousness of our endeavor to "seek out the truth" and to fund their research "without any strings attached...." Our original approach "gambit" was to tell them that we had been trying for several years to convince our U.S. parent Company to authorize our German and other European Companies to fund research in Western Europe and, firstly in Germany, because of our convictions that some research in Western Europe in general, and in Germany in particular, is at least as good as the best U.S. scientific efforts.... It was also generally agreed that it would be desirable to maintain our relationship entirely confidential....We believe that the results to date already assure us we will be able...to show the Verband that it is possible to support first rate research by top quality scientists from Germany’s most prestigious institutions where the research is open in the sense that like all worthwhile research, results are not foregone conclusions or, in other words, worthless. [N.B. Given the low opinion Colby and others had of German research, there was clearly another motive, as shown in the next sentence.] At present we cannot expect that any of our current grantees would consent to be a witness in the eventuality that our German Company would have to defend itself in a liability case. However, W[ilfried] Dembach seems to think that no such witnesses will conceivably be needed before 1980. [N.B. The appendix to this report gives the sequence of dealings with Dieter Neuberg, indicating his value to RJR was more as a prestigious scientist than his research.]

Colby then reports on the September 11 meeting in London with Drs. Adlkofer and Koenig; attending were Ed Jacob, Dr. Charles Nystrom, Colby, and Dembach.

Mr. Jacob then proceeded to explain the dangers of nicotine research from the point of view of the Industry, with special reference to the threat of the American Industry being placed under the jurisdiction of the Food and Drug Administration. He also mentioned that some work of the Council for Tobacco Research-U.S.A. on nicotine "receptors" had to be terminated because of a possibility of such work being wrongly interpreted of having commercial implications. Dr. Koenig then claimed that he was aware of the specific problems of the American Industry supporting nicotine work in Germany through its German affiliates which could be alleged to be related to such problems as addiction. Dr. Koenig and Dr. Adlkofer then stated that in their judgment it was desirable to find out more about the effects, if any, of nicotine in laboratory animals on cancer, arteriosclerosis, pregnancy, etc. Mr. Jacob then state that under no circumstances would Reynolds support any research in Germany that we would or could not support in the U.S.... We then somewhat forcibly and -- deliberately -- overbearingly extracted from them an unequivocal promise that before any effort which was made to commence or in any other way start a specific research project, RJR -- like the other member Companies of the Verband -- would have a minimum of three months to evaluate each proposal.... Almost all of the meeting in London dealt with the legal perils and related aspects of the concepts on nicotine oriented research of the Verband.... I also tried to explain to Dr. Adlkofer and his associates why I considered the other "cornerstone" of his research concept, i.e. the so-called compensation study, scientifically totally worthless. [N.B. Jacob’s concern was that research showing putative benefit of nicotine would lead FDA to classify it as a drug, hence regulate it in tobacco.]

Colby goes on to suggest Adlkofer stick to basic research on human disease "alleged to be associated with tobacco," however, ‘by definition,’ such research could not deal with tobacco.

Colby then turns to the Chairman of the Research Council, a Prof. Schmaehl, who "a widely known expert in chemical cancerogenesis, is receiving financial kickbacks from some of the current research grantees of the (Verband-financed) German Tobacco Research Council...for personal use."

* 8 December 1978, Colby memo to H.C. Roemer, RJR 500871996.

As an example of its "watergate" endeavors, the German Verband has made funds available to Dr. Wynder for his American Health Foundation [in New York City], to be the front in financing a Symposium on carbon monoxide,held in Berlin in October (‘78) .

# 6 February 1979, Report by A.W.M. St. Aubyn to Philip Morris, "Visit to Verband der Cigaretten-Industrie, Hamburg, 30th and 31st January 1979." PM 2501159601 - 9607.

A comprehensive review of the Verband activities including public relations and responses to attack, "at arms length," that is, through third parties: publications and films for the public and health professionals from independent film makers and publishers; comparing all risks to health; aligning with specialist physicians; presenting a positive outlook, not offensive, to maintain the social acceptability of smoking. Two paragraphs stand out:

Risks. The type of clandestine operations in which the VdC is involved clearly carry certain risks of detection, by such people as investigative journalists, of the link between the industry and the end product. HK [Harold Koenig] believes that the precautions they take are sufficient to enable the industry to be able to deny any link and says that such risks as remain are acceptable to the VdC member companies.

By this form of combined approach the German industry seems to have defended itself better than many countries from the worst excesses of the various anti-smoking lobbies and has maintained a higher standing for itself and its product in the public mind.... [M]any of the methods used there could well be suitable for adaptation to the U.K. context.

* 2 March 1979, VdC Tabakforschungsauschuss (TFA -- Tobacco Research Board) meeting notes taken by Bernd Pelz (RJR Germany) [N.B. Pelz eventually goes to work for RJR’s Foxfire Plantation, a tobacco growing station in the USA], RJR 500920533 - 0534.

Nitrosamine research by a facility identified as Austraton approved, carcinogen studies by Prof. Schmaehl rejected. A study at Austraton on the effect of smoke of smoke on DNA repair in hamsters is mentioned (no details) as well as Dr. Scherer’s literature review on co-carcinogenic properties of nicotine.

Adlkofer felt it was impossible to decline Schmaehl’s suggestion (political consideration and not suggesting a modified research protocol [Adlkofer suggests applying condensates on mouse skin from cigarettes with varying tar: nicotine ratios and from cigarettes made 30 and 10 years ago.] The committee members felt that such research would not reveal anything new.... [They] were unanimous in saying that they see no clear cut need for an alternative proposal.

* 26 March 1979, Letter from W. Dembach to Dr. E.B. Brueckner, Research Society on Smoking and Health, RJR 500924525.

Letter advances RJR payments for research projects invoiced but notes that RJR is only paying for projects it has already approved, not new projects not yet reviewed.

* 19 April 1979, Colby memo to Alan Rodgman, "Information for Dr. Laurene’s weekly meeting with Mr. Hobbs. RJR 501627697 - 7700.

This is one of the few "attorney-client privileged" documents that is additionally heavily censored ("privileged material redacted"). A hand-written cover sheet reads "Please read & destroy without making copies."

Surprisingly, the Verband had decided to invite Dr. Gori, apparently without checking ahead of time with the member firms, more specifically with RJR-GmbH.... Dr. Gori "buttonholed" me a the Verband meeting and asked me point blank whether "I agreed that the German Tobacco Industry is sponsoring research which would not be permitted by your lawyers in the United States." I thought it futile to deny the obvious or to reply that I could not comment. I stated therefore that we only had a very small market share in Germany and that our influence was therefore limited. (Confidential). [N.B. Gori was employed at the National Institutes of Health, heading up the smoking and health program; he sought for years to develop a "safe" cigarette.]

* 26 April 1979, Colby trip report to Max Crohn, "Trip to Germany...some highlights-mainly on Verband grantees meeting..." RJR 504821254 - 1256.

As others and I predicted several years ago when this Council was first organized by the Verband, the outcome was the worst of two possible worlds; (1) Poor, or at best, mediocre science, (2) Most of the findings were negative from an Industry point of view. The only somewhat favorable aspect of the activities of the Council is that it probably helped the Verband establish a non-confrontation, though not an amicable relationship with important German Government Health and related authorities....

* 23 May 1979, Colby memo to Alan Rodgman, "Information for Dr. Laurene’s weekly meeting with Mr. Hobbs." RJR 500885452 - 5453.

Colby attended the Scientific Technical Advisory Group of ICOSI in Brussels, and provided "intelligence" on Philip Morris/Europe, BAT, and Imperial.

PM/E has had for several years, as a wholly owned subsidiary, a major commercial research institute in Cologne/Germany, which does animal and other biological research. PM/E has completed a study on analyses of cigarette, respectively filter tip, stubs, comparing tar/nicotine intake of cigarettes about twenty years ago, i.e. mostly non-filter cigarettes having high nicotine/tar deliveries, vs. Recent cigarettes, i.e. mostly filter cigarettes having high nicotine/tar deliveries. The results allegedly show that there is no substantial difference in nicotine intake by Swiss smokers as a whole... [I] can not make a judgment how valid the PM conclusion is that there is "compensation."

In the same memo Colby noted the retirement from BAT of senior scientist Dr. Green, soon to be a whistle-blower.

* 29 May 1979, Colby report to S.B. Witt, "Philip Morris/Europe." RJR 500942103.

Verband and Dr. Schmaehl (German Cancer Institute) managed to get a paper on nitrosamines by an ex-PM reseacher, now with Wynder’s American Health Foundation, presented at a seminar sponsored by Schmaehl. Colby also reports that PM is enlarging their R&D facilities in Neuchatel, and "has had for several years, as a wholly owned subsidiary, a major commercial research institute in Cologne/Germany, which does animal and other biological research." In Neuchatel they discovered that Swiss smokers using low tar/low nicotine filter cigarettes get the same amount of nicotine as when they smoked the old non-filter high tar and nicotine cigarettes. Colby tries to downplay the importance of this finding: "This type of study requires a great many assumptions."

# 4 June 1979, Memo from BATCO’s D.G. Felton to S.J. Green, L.C.F. Blackman (BAT researchers), "Meeting with Philip Morris’s Dr. R. Seligman (V.P. R&D) and Dr. T.S. Osden (Director of Research) Philip Morris Research Center, Richmond, USA." Minnesota Depository BAT (File no. C12) 100429313 - 314.

They commented that, in their opinion, ICOSI was a ‘conspiracy by Reynolds and Imperial to thwart BAT and Philip Morris’ in their international operations. They clearly did not trust Colby or Jacob and said that the Verband staff (Konig and Adlkofer) had found Jacob a trial. I said that I understood Jacob had advised ICOSI that there was danger in working on nicotine for a variety of reasons and that might have had repercussions for the Verband."

* 3 July 1979, Redacted Colby attachment of abstract of a study by German scientist to lawyers Witt and Jacob, "Effects of Smoking on Human Umbilical Veins." RJR 511286585.

Pathological changes found in umbilical arteries and veins of children of smoking mothers, and not in non-smokers. Related to low birth weights of such children.

* 19 July 1979, VdC TFA meeting notes by Pelz to W. Dembach (RJR German counsel), RJR 503247057 - 7058.

Members express great dissatisfaction "with the way the TFA is handled by the VdC."

They complain of wasted money ("unless one rated the public relations effect that high"), that research was not being used to produce new cigarettes, and that Adlkofer had arbitrarily chosen the members of the new Forschungsrat (research-proposing and grant-making body of VdC).

# 20 July 1979, Colby letter to Dembach, "Re: Verband Executive Meeting, June 26, 1979." RJR 500920451 - 0453.

Colby comments on a paper Verband intends to send to the German Medical Weekly. "I find especially the comments preceding the actual report on the...reference to alleged adverse health effects of smoking, as well as the references to the ‘less harmful cigarettes’, scientifically unacceptable and politically unpalatable." Colby also objects to Verband research on polycyclic hydrocarbons and electrostatic precipitation of cigarette smoke - particularly because adversaries would "manipulate" the methodology and information.

# 2 August 1979, Colby memo to RJR in-house counsel S.B. Witt, "Verband grantees." RJR 503247017.

Colby complains of the Verband report, "Research grantees," where "some comments which wrongly allege that cigarette smoking is harmful."

* 5 August 1979, Colby letter to Dembach, RJR 50872449.

Colby likes a Prof. Krokowski’s "open-minded attitude towards smoking for years," and notes that he is "the first good potential candidate to serve as ‘witness’." [N.B. Colby was the first to develop a method of recruiting "friendly" scientists and medical doctors by careful screening. The method was formalized a decade later in the Asian and European ETS Consultant Projects, among other such programs to find friendly witnesses for litigation and testimony at legislatures.]

# * 8 August 1979, Colby memo to Alan Rodgman (RJR Senior Scientist), RJR 502443594- 3595.

The sometimes cosy relationship of the Verband with government officials is illustrated here: "Some time ago Don Hoel, of Shook, Hardy & Bacon, received a request from the Chief Executive of the Verband [von Specht] – who is also the Chief executive of B.A.T. Germany – to furnish him ‘pro and con’ material on nicotine for the purpose of transmitting it to an anti-tobacco bureaucrat of the European Economic Community. To my astonishment, Mr. Hoel complied with that request as made."

* 28 August 1979, Colby letter to Franz Adlkofer, RJR 500872130.

Colby expresses the need to hide RJR’s sponsorship of University research in Germany:

As I informed you, Dr. Koenig, etc., several months ago, we, i.e. R.J. Reynolds GmbH in Cologne, are sponsoring a limited amount of ‘smoking and health’ research in German Universities. At that time I also advised you that these projects would have to remain confidential between the researchers and ourselves until data ready for publication would be available.... Attached please find the manuscript of the first of these studies.... Please keep this manuscript confidential until publication, and our involvement in this project should, please, also be kept confidential until advised otherwise.

* 29 August 1979, Colby memo to Alan Rodgman, RJR 50162-7508, "Monthly status report." RJR 503247017.

Among other activities, "Obtained confidential information on the relationship between the British Tobacco Industry and the Hunter Committee."

* 5 September 1979, Colby draft memo to RJR in-house counsel S.B. Witt, "RJRTI funding of smoking and health research in Germany and elsewhere." RJR 500950146- 0148.

$750,000 over three years. Purpose of research is to fund "impeccable" smoking and health research. But under that rubric is the substantial reason, recruiting spies and witnesses:

To establish relations of mutual trust with leading scientists -- beyond the grants – as scientific advisers, as a resource to find "witnesses" – if needed – for liability litigations, governmental bodies, etc., as a confidential source of information on the activities of our adversaries, etc.

Projects funded by the Verband often done by scientists hostile to the tobacco industry: "Obviously, ‘politically’ such data are doublu damaging if financed by the industry.... Funding ‘impeccable research also means to exclude...researchers prejudiced against the Tobacco Industry.

* 14 September 1979, Colby memo to S.B. Witt, "Verband Smoking and Health Research Grant Procedures." RJR 503246989 - 7011.

Colby outlines the grant making procedures of the Verband, "adopted over our objections."

1) There will be projects submitted by, or solicited from various university and research institute scientists. These will be evaluated as to their scientific merit by the new German Tobacco Research Council (see below). However, the Executive Board of the Verband reserves itself the right to veto or otherwise control publication. 2) The Verband, i.e. Adlkofer and company, will originate other projects and choose their researchers within Germany and, possibly, also outside Germany, in a form akin to what we call in this country "contract research." For this type of project the Verband plans also to reserve itself the right to veto or otherwise control publication.... Chiefly due to Ed’s [Jacob], Wilfried’s [Dembach], and my initiatives, the Verband has agreed that all member companies will have three months to comment, before any irrevocable commitments are made. (I am, however, skeptical whether the Verband will always be scrupulous in observing this.) Any company has the right to withhold its funding from any project. Similarly, there seems to be an unwritten understanding that any member company may veto any of the projects.... The Verband has asked approval of a specific research proposal ("Effect of carbon monoxide and nicotine on minipigs"), which in the judgment of Dr. Pelz and myself, is totally ill conceived. Also, nearly all the scientists of the other firms are against this project.

Colby also objected to some appointees to the Research Council, "personal friends of Dr. Adlkofer." especially Prof. Schettler.

* 19 September 1979, Colby memo to S.B. Witt - includes portions of 5 September 1979 memo, , "RJRTI Financed Smoking and Health Research in Germany to Date -- 1977-79." RJR 500877333 - 7342.

Colby describes the kind of research RJR has funded: 1) Whether lung cancer and/or smoking are associated with a person’s psychological makeup, war experiences, religion, etc. $200,000 annually. 2) Whether the handwriting of lung cancer patients can reveal characteristics associated with lung cancer. $18,000. 3) Enzyme markers in human cells predicting susceptibility to lung cancer. "The CTR-USA and other organizations have spent millions of dollars on this concept.... Results to date have been disappointing and the original concept is now very much in question." 4) Toxicologically caused cancer "threshold" theory. "Incomplete results to date -- involving chemicals in no way related to tobacco -- have not turned out as hoped for." $110,000.

5) Epidemiologic study of total Cancer rates in Hamburg, corrected for shift in population and improved diagnoses, have not changed, but locations of cancer have [Colby doesn’t specify!]. $25,000. 6) Comparison of "annoyance" from second-hand smoke to other industrial odors. $35,000. 7) Dr. Neubert’s studies on [voluntarily] aborted fetuses from smoking and non-smoking women. Obstacle to study is a change in voluntary abortion methods. Neubert proposes going to animal models. $48,000. 8) Chain-smoking Prof. Staecker believes extroversion causes both smoking and "certain respiratory patterns." $58,000.

# 24 September 1979, Colby memo to Dembach and Bernd F. Pelz [N.B. Pelz was RJR- Germany scientist assigned to keep track of Verband deliberations and operations, see RJR 50087738.], "Verband Research Projects Approval." RJR 50094522 - 4523.

Colby confirms the Verband procedures as outlined to S.B. Witt 14 September 1979. Emphasizes need for close RJR review of ALL proposed projects (not just those, apparently, funded by RJR). "These projects need not only be assessed from a purely scientific point of view, but also from a legal point of view (i.e. Sam Witt, Ed Jacob, etc.)."

* 5 October 1979, Colby memo to S.B. Witt, "Verband Research Project -- Umbilical Cords Pathology." RJR 503246995 - 6996.

Colby writes, "The Verband is planning to undertake a new research project which is described in the attachment. I am planning to advise Wilfried Dembach and Bernd Pelz as follows, provided you approve." He objects not to the research (ostensibly looking at cords of infants delivered to smoking and non-smoking mothers) but to the researchers who have been associated with or published research on pregnancy and smoking or on minipigs, "which are mostly very anti-smoking," and "a serious embarrassment to the German Industry."

# 5-8 November, 1979, synopsis of conference, unsigned, "Smoking and health issues conference. BAT (Minnesota Select set, BOX 11, File no. FC0077) 301097811.

The German example indicates that the industry’s greatest ally is its consumer. The Verband shows that a dialogue through third parties with the scientific community on the health aspects of smoking can reflect well on the industry and avoid isolation.

* 19 November 1979, memo from Bernd Pelz to W. Dembach, "VdC-Tabakforschungsausschuss (TFA)-Meeting." [Verband Tobacco Research Committee.] RJR 500877295 - 7298.

Second of a number of reports by Pelz, assigned to report on the Verband research deliberations. The TFA became the successor to the Forschungsrat (Research Council). The researchers discussed the need to "do something about nitrosamines in smoke." Pelz reports, "Heavy metals in smoke. This discussion I regard a personal victory: there will be no research follow-up by the Verband on the publication by Prof. Mueller on Cadmium in tobacco."

* 19 November 1979, VdC TFA meeting notes by Pelz to Dembach, RJR 500920074 - 0078.

Much discussion on nitrosamines in tobacco and the need to reduce their levels. Discussion of cadmium in tobacco. Evidence that the different companies had to be careful of their competitive advantages, and not share research ideas. A secret side-note to RJR USA reveals how VdC is influencing a European Commission Literature study on tar and nicotine.

Nitrosamines in beer to him [Fink of PM/Neuchatel, FTR, Fabriques Tabak Reunies] are not an issue any more after the changes that were introduced by the brewing industry.... [H]igh nitroso-nornicotine (NNN) values found by Hoffman were also found in experiments by PM. Dr. Klus essentially reached the conclusions made by Fink, that tobacco industry should do something about nitrosamines in smoke.... Seehofer [BAT] wanted to know from Dr. Fink what leads he would use to get a reduction of nitrosamines in smoke. Fink said they would work on it, but was not in a position to say more.

Heavy metals in smoke: This discussion I regard a personal victory: there will be no research follow up by the Verband on the publication by Prof. Muller on Cadmium in tobacco, and unless necessitated by outside pressure the subject will not be on the agenda of the Committee for the next year.

When discussing the problems of Coresta, it became pretty obvious that practically all companies for competitive reasons have restricted or put a ban on scientific publications. Dr. Fink (PM) for example reported that in general 3 out of 4 potential publications are rejected [by his company].

European Commission Literature Study (This is strictly confidential and not for outside use) The EC Commission has contracted the Fresenius Institute to do a literature survey on the determination of tar and nicotine and other toxicologically relevant constituents of tobacco smoke. The VdC has been in touch with with Institute since Spring 1979 and is supplying cost of the literature. Dr. Fresenius in discussion with selected TFA members....

# 20 November 1979, translation of memo by E. Brueckner of the Verband to Verband members, "regarding biological experiments," RJR 50087-2076.

A clear alarm that non-industry government research could harm the industry, and acknowledging the link between cigarettes and lung cancer.

We have just been informed on a confidential basis that a leading German research institute is doing, on behalf of the German Federal Ministry of the Interior, inhalation experiments on the effect of cigarette smoke on lung retention of dusts. Asbestos is also included in the experiments. The researchers have been requested to use conditions which simulates actual real life conditions as closely as possible. For that reason they use in their experiments several (German) cigarette brands which have a high market share. It seems questionable whether the results to be expected will, in all cases, lead to an exoneration of cigarettes, especially since we know from the United States that 97% of the asbestos workers which died of lung cancer, were smokers. We will continue to follow this topic and explore whether or not we will be able to use our influence.

# 21 November 1979, Edwin Jacob memorandum to files, "Meeting With Executive Board of Verband re Research Structure November 13, 1979." PM 100012218 - 2222.

I had referred to the statement of research concept agreed with Konig [Harold Koenig] during our meetings last year...and changes were made in the draft statute for the Research Council, as follows: I) References to product development or improvement were eliminated from the statute. ii) No scientific approval of the Verband or members of the Industry will be required for specific research projects. iii) There will be no requirement that the Council make recommendations with regard to product improvement.... Part of the problem [how to engage company scientists in the Council review of projects] might be in asking the wrong question. It is not helpful to obtain negative reaction of the scientists and then go forward on political grounds. It might be more helpful to tell the scientists that a political decision to do a project has been made and invite their cooperation in making it as effective as possible, given whatever the political parameters might be.

* 28 November 1979, Richard Marcotullio (RJR "Managerial Employee"), memorandum to file, "ICOSI International Public Smoking Symposium." RJR 502122792 - 2797.

Long soliloquy about a major conference on public smoking whose industry sponsorship the Verband wanted kept secret, otherwise it "would preclude the ability to attract the participants desired," that is, the best scientists, as well as the expected participation of the World Health Organization. Marcotullio and others were of the opinion that this should be an industry show, not a venue for scientific or legal debate or controversy. If anything, the pressure on individuals to stop smoking ought to be raised as "debate" with the intention of "discrediting the other side." Therefore, only participants siding with the industry should be on the program, "producing testimony and a report which can be used with legislators." The three aims of the symposium would be to produce a useable book, provide media coverage ("highly organized"), and to "neutralize WHO as best as possible on the public smoking issue." "In addition, the symposium was intended to establish witnesses, international sociologists, lawyers and scientists that the industry could count on in other areas." [N.B. The proposed convener of the conference is named simply as "IO", a local branch of an international group, one with good relationships to the Verband and also to the World Health Organization. "IO" probably stands for "Interim Organization," the entity that bridged the 1979-1980 transition from ICOSI (International Center on Smoking Issues) to the more controllable INFOTAB. See * RJR 503328264 - 8272, particularly -8767.]

Of interest in this memo is the close coordination with law firm principals, such as Mary Covington of Covington & Burling, Don Hoel and Charles Tucker from Shook, Hardy & Bacon ("Kansas City"); and the major manufacturers BAT, Imperial, Philip Morris, and RJR.

* 30 November 1979, Colby memo to Pelz, "Adams ‘Compensation’." RJR 503247368.

[N.B. "Compensation" refers to smokers of low tar, low nicotine cigarettes inhaling more deeply and longer to get the requisite amount of nicotine their bodies demand.]

For reference I attach two recent papers by Dr. Adams. As I am sure you are aware, the "politics" of Imperial "demand" that there is no compensation. The Verband’s politics have changed radically in that the late Dr. Weber insisted that there was no compensation, but now Dr. Adlkofer wants to show compensation. In my judgment, as regards the majority of convinced smokers, there is compensation ...[but] is only partial

over the long run...from the point of the smoking and health controversy...this is probably meaningless. This is because there is no way of determining the smoking behavior changes -- if any -- of the very small number of smokers who may or may not be "at risk" with regards to diseases allegedly associated with smoking.

* 6 December 1979, Colby to S.B. Witt, RJR, the Research Council for Smoking and Health and Verband "Statute" and declarations of purpose, in German (undated) and partially translated to English. 500877291 - 7294. [N.B. The English translation of the Purpose of the Research Council is totally redacted from this document.]

In rough translation, the statute declares that the purpose of the Research Council is to discover, on the basis of present knowledge, if or how nicotine, alone or interacting with other substances, takes part in the pathogenesis of chronic illnesses associated with smoking. Because of the importance and extent of this area of work [smoking and health], nicotine research

is at the center of the activities of the Research Council. Basic research will take suitable note of and be based on clinical studies. In certain instances work with other scientific disciplines will give meaning to the results.

# 13 December 1979, Meeting notes from Bernd Pelz distributed to Colby, Dembach, Alan Rodgman, H.J. Weder, S.B. Witt, "VdC Scientific Committee (TFA) Meeting, Hamburg Dec. 12, 79." RJR 500920366 - 0372. [N.B. TFA stands for Tabak Forschungs Ausschuss, Tobacco Research Committee.]

Scientists at the meeting represented BAT, British Imperial, Philip Morris, Reemtsma, RJR, VdC, and Austria Tabakwerke.

A paper on nitrosamine levels in many brands of cigarettes from different nations was published by Drs. Ruhl, Adams, Hoffman in a reputable but Verband-financed German tobacco research journal ("Beitrage zur Tabakforschung [Contributions to Tobacco Research.."]. It was felt "not what one would like to see" but an attempt by the Verband to suppress it would be undesirable given the cooperation of the German Federal Health Office in the study. The Reemtsma representative objected, however. The same Dr. Adams continues to show compensation behavior of "light cigarette" smokers. Pelz then related a discussion about the Verband with two company scientists (Austria Tabakwerke and PM) on the way to the airport. "They both said that approval of Verband research was more or less based on a general judgement as to what potential harm a piece of research could do." Pelz’s own role in insisting on more information about research protocols, they warned, could lead him to be marginalized. Both scientists said appointment of Adlkofer to head the Scientific Committee was a mistake "because this would add too much influence to the Verband. They would also prefer to have the chairmanship in the hands of members of industry."

# 17 December 1979, Marcotullio memorandum to the file, ICOSI - International Public Smoking Symposium." RJR 502122771 - 2778.

Soliloquy continued from 28 November, with an apparent change of heart by the ICOSI at a 12 December meeting attended by writer, and law firm principals Ed Jacob and Charles Tucker. The memo indicates the Industry’s need and ability to influence the World Health Organization away from an active anti-tobacco stance.

The WHO Sub-director [Tibblen] has apparently been offered by the proposed public sponsor of the symposium, the ‘IO’, and the ‘IO’ has apparently indicated that while the sub-director will not be totally on our side his remarks will be fairly moderate. It was also felt that this would add to the credibility of the symposium in that it would not be totally one-sided.... Controlled controversy rather than balanced controversy.... If Tibblen makes his point.... The response to Tibblen will comes from carefully briefed and placed floor discussion people.... The Verband has full control over the ‘IO,’ Resulting from a long history of cooperation between the Verband and the ‘IO’.... Trevor King of Imperial Tobacco expressed his concern that WHO was being asked to be a party to a ‘balanced’ conference’ where its views were then going to be discredited. He further questioned why the ‘IO’ would want to put itself in this position and [Christian] Vogel [of ICOSI] responded that ‘it’s a question of who is the biggest supporter of the IO.’ Julian Doyle [ICOSI director] then commented that the ‘IO’ was apparently chosen because of its relationship with WHO.

Further discussion of how to organize the symposium centered on whether "IO"/ICOSI should act as the convener with secretive funding to come through the Verband. The Americans (industry and lawyers) objected because of the possibility of discovery, the Europeans refused a symposium where industry sponsorship was openly known. The circuitous solution was for Verband to support IO sponsorship, with other and more neutral sponsors also sought, and the industry role in sponsorship not be proclaimed but not denied either if asked.

* 20 December 1979, Colby letter to Jacob, commenting on Pelz’s report of

13 December 1979. RJR 500872965.

Company scientists don’t understand "that most of the research funding by the Verband will not be funneled through the Research Council, but directly via contract research." Colby still insists on a three-month review period by RJR (and other firms) of all research proposals.

* 10 January 1980, Colby memo to S.B. Witt, " Smoking and Health and Related Activities for Germany, etc." RJR 500882843 - 2845.

Job description for Bernd Pelz. Essentially to "monitor and assess any and all activities of the Verband:" scientific, legislative, court testimony, support of scientific meetings, contacts with researchers outside Germany, contacts with tobacco trade associations and tobacco companies outside Germany. Colby notes two kinds of funded research - Verband support of projects cleared by the Research Council, which require limited monitoring "provided they stick to their agreements," and contracts funded by tobacco companies directly, which require more extensive review with three months notice.

* 10 January 1980, Colby memo to Dembach, "Verband research on smoking motivation by Bergler." RJR 500882850.

Verband commissioned research on the role of advertising "is obviously a sensitive topic and in my judgment, it falls under the subjects where there should be some input from Winston-Salem, before any commitments by RJR are made."

* 14 January 1980, VdC meeting notes by Pelz to Samuel Witt (RJR counsel) Alan Rodgman and Frank Colby (RJR scientists, Dembach and Weder (RJR German counsels), RJR 500882856 - 2857.

Discussion of merits of the Cambridge filter versus the electrostatic trap for measuring tar and nicotine, and establishing international standards that would make the cigarette companies look good, as the two methods produce different results. Obvious attempt at gaming the system.

When using ventilation to reduce carbon monoxide in cigarette smoke, nicotine is reduced to a lesser extent than tar, i.e. the measured T/N ratio becomes smaller. This is basically desirable, but should not become apparent in measured and labeled values.... There are reasons to believe that the taste impact of a product is determined by its T/N ratio. To achieve a low T/N ratio, the possibility should exist to have the nicotine as high as possible, without this becoming apparent. Since the electrostatic trap reduces tar more than nicotine, compared to the Cambridge filter, i.e. increases the T/N ratio, the use of the electrostatic trap thus runs counter to the interests of industry. The attempt of Health Authorities in various countries to reduce the tar values also would make it appear more desirable to have the international standards produce higher tar values to have a wider lee-way.

* 14 January 1980, Colby memo to S.B. Witt, RJR 502856873, "False allegations made by German semi-official Health Insurance."

The Dusseldorf branch of the semi-official German Health Insurance, which insures about 70% of all West Germans, made the following false allegations: 1. "There is a cause and effect relationship between cigarette smoking and various diseases."

2. Tobacco advertising induces children and young people to smoke." 3."Smokers are insufficiently informed regarding the effect of smoking on health." The Verband has replied over the signature of Mr. von Specht regarding point 1. That "risk factors" are not synonymous with causation, and that relationships between smoking and health are a matter of controversy.... Regarding point 2, the Verband stated that not a single study backs up the insurance’s claim.... Regarding point 3, it was pointed out that all press, radio and TV polls have come to contrary conclusions.

* 18 January 1980, Colby draft of memo to S.B. Witt ("no copies"), RJR 500882851 - 2855, "Smoking and Health in Germany."

Suggestion that all is not well as Colby complains of not being informed on all issues and by all meeting minutes, whether from the Verband Tobacco Committee (TA, a technical group comprising one R&D scientist from each company), the Tobacco Research Committee (TFA, the policy level committee headed by Dr. Adlkofer), and the Executive Board (made up of CEO’s of each of the member companies or their delegates, who scrutinize all research proposals). Colby still strongly objects to nicotine and compensation studies, which appear to be going ahead despite his protests.

* 25 February 1980, Richard Marcotullio memo to S.B. Witt, "Germany -- Legal action against Reemstma." RJR 502122978 - 2979.

Advises that the leading anti-smoking group in Germany, Physicians Working Group on Smoking and Health (led by Professor Schmidt) is suing Reemstma for using posters with a young, healthy model advertising "Brand X", suggesting no ill-effect from smoking in contravention of the German Food Law. The case is being taken by an avowed anti-smoking judge, whose wife is also a judge and a "paranoid" anti-smoker." Another lawsuit is being instituted by a long-time smoker (smoking the same "Brand X") who suffered a heart attack and was told by his physician that smoking was the cause.

* 29 February 1980, letter from Samuel Witt (RJR counsel) to Alexander Holtzman (PM counsel) with meeting notes of the VdC Scientific Committee 14 February, RJR 500880088 - 0091.

This report shows the concern early on from the German side of any findings implicating tobacco as a hazardous product.

Adlkofer adds a new member from Reemstma, against the VdC Board decision to limit each company to one representative. [N.B. VdC Board is made up of the CEOs of the several companies, therefore the policy-making committee where politically sensitive scientific questions are decided.] Research proposed on mainstream and sidestream smoke for carboline compounds [polyaromatic hydrocarbons]. A mention of an Austrian Professor Kunze who relates tar levels with lung cancer; a paper by Ruhl and Hoffman on nitrosamines scheduled for the industry journal Beitrage zur Tabakforschung [Contributions to Tobacco Research]; that a 1979 German list of exposure to workplace chemicals mentions smoking for the first time.

Dr. Klus [Austria Tabak] reported about the situation in Austria, where Prof. Kunze is going public with ‘tar exposure numbers’, i.e. where he relates incidences of lung cancer to tar exposure. The formula he is using is number of cigarettes smoked X years of smoking those cigarettes X tar factor = exposure number. The tar factors he is using are... less than 15 mgs... 15-24 mgs... 24 mgs. And exposure number below 500 is equated by Kunze to a low risk of cancer; above 2500 to a substantial risk, and above 5000 to a high likelihood of cancer. The additional problem with Kunze is that he is publicly blaming certain brands for being dangerous.... Austria Tobacco Co. is currently preparing a defensive position paper....

Except for Reemstma, all committee members feel that a letter of the kind proposed by Dr. Adlkofer...would induce Hoffman to withdraw the paper, and allow everybody to save his face. Reemstma will ask the VdC Board for a final decision. Reemstma may also want to discuss the usefulness of the existence of Beitrage in general.
Looking into the future Adlkofer said he expected the work of the new Forschungsrat to be neither beneficial nor detrimental to the interests of the industry, and its prime significance being that of a positive public relations effect.

* 6 March 1980, Colby memorandum for the record, " Re: Meeting with Dr. Adlkofer, March 6, 1980 in Houston, TX." RJR 511468214 - 8215.

Colby quotes Adlkofer as saying that he believed "risk factors were more or less synonymous with causation." Colby relates further, "In the sum he believes that smoking ‘causes’ lung cancer, heart disease.... He also believes that low ‘tar’ low-nicotine cigarettes are less harmful."

* 11 March 1980, memorandum from Robert Seligman (PM scientist) to Alexander Holtzman, PM counsel, "RJR Meeting notes from VdC, PM 1000122363 - 2364.

Commentary on VdC proceeedings – the RJR notes seem to make the rounds. The entire memo is worth quoting for the legal cover that is being thrown up around the science.

Thank you for sending the meeting notes written by Mr. Pelz. I found them very interesting. You asked for comments and they follow: The statement by the President of the German Federal Health Office that people compensate when smoking low-tar cigarettes is a bit disturbing. I don’t believe there is factual proof that this takes place. [N.B. This was known to the industry by the mid-1970s.] To have a Federal official infer that low-tar cigarettes are industry instigated rather than marketplace dictated is erroneous and should be challenged. The VdC’s interest in harmane/norharmane and the carboline compounds is significant. The harmanes we know are present in smoke and the carbolines may be present in smoke. Some of the latter compounds are extremely carcinogenic and have been claimed by Dr. Sigimura of Japan of being the "ultimate carcinogen." Professor Kunze’s (of Austria) exposure numbers and inferred relationship to the likelihood of cancer is an extremely dangerous development. It makes the Hertzfeld index and the Gori Index child’s play. It is particularly damaging if he publicly cites specific brands. On the subject of Beitrage, it would be most unfortunate if this publication ceased. It is the one publication of international stature within tobacco technology groups. Listing smoking with other chemicals is an unfortunate precedent. I’d hate to see "threshold limiting values" for Marlboros in U.S.A. industrial sites. I’d be pleased to have your comments on the above. [N.B. Harmane and norharmane are of the alkaloid class of carbolines, "fused-ring N-heterocyclics"; harmane has some use in Parkinson’s disease but the chemical class may be precursors to nitrosamines. See Schmeltz and Hoffman, "Nitrogen containing coumpunds in tobacco and tobacco smoke," Chemical Reviews 1977; 77: 295-311.]

* 14 March 1980, Colby letter to Dembach, RJR 504339741.

To the best of my information, lung cancer has been increasing in German fairly steeply between 1955 and the present. All this does not jibe with German cigarette consumption. For example, between 1933 and World War II, German cigarette consumption had been increasing. However, during World War II, there was a very marked dip in consumption, due to lack of tobacco; then, consumption has been increasing during the first few years after World War II, but from then on it has allegedly been decreasing, especially if viewed in terms of "tar"/nicotine contents. Even making the most generous allowances for lag time, these two sets of data can not be reconciled. In my judgment, this is one of many examples that show that the allegations of a causal association between smoking and lung cancer cannot be reconciled with the facts.

Colby then asks Dembach to get Verband data on consumption, and cancer data from the Government.

* 18 March 1980, Dembach letter to Edwin Jacob, RJR 502742741.

Advises that a Verband publication, "Tobacco Booklet" is ready, to be distributed to employees only, that he succeeded "95%" in promoting a "less risky version. If however, extremely delicate things are hidden in the booklet, please tell this to Sam (Witt) and Frank (Colby) who will then decide together with me what to do."

* 27 March 1980, Pelz meeting notes to Dembach, "VdC scientific Committee (TFA) Meeting, Hamburg March 26, 1980." RJR 501545782 - 5784.

Smoke’s effect on hamster cells seems to increase DNA synthesis in lung cells, decrease DNA repair in spleen. Professor Obe finds higher chromosomal aberrations in peripheral white blood cells (lymphocytes) in smoking alcoholics compared to non-smoking alcoholics. A minipig study (ETS?) is approved, also an umbilical cord study. Pesticides were discussed.

Nitrosamine paper by Hoffman - Ruhl. Following a pertinent VdC Board decision, Dr. Adlkofer one way or another managed to have Dr. Hoffman [with Ernst Wynder’s American Health Foundation] withdraw his publication on nitrosamines in the smoke of German cigarettes. He is now said to publish in the ‘Lebensmittelchemie’Journal , which will have a much larger readership than Beitrage, but obviously is not edited by tobacco industry.

* 10 April 1980, Colby letter to H.C. Roemer (in-house counsel), RJR 512384899 - 4900.

Colby reports on the progress of various German researches: the "annoyance" study, the chemical threshold of cancer causing agents study. Colby wishes to discuss continued funding on the latter to a Dr. Henschler,

...one of the foremost German and International scientists, especially in the area of toxicology. Dr. Henschler has been extremely helpful in the past...in aiding us to best achieve our two objectives of funding impeccable smoking and health related research by open-minded scientists and to assist our German company and RJRTI in Europe in general, to assume in other countries a similar industry leadership role as in the United States.

Colby discusses a Prof. Oeser, University of Berlin, who says that while overall cancer incidence in Germany has remained stable, lung cancer may be an exception; "he alleges that smoking is probably one of the principal causes of lung cancer. The purpose of my visit [to him] will be to try to sway him -- or at least induce him to give this matter a great deal of further thought."

* 23 May 1980, meeting notes, Walter Fink (Philip Morris/Neuchatel Fabriques Tabak Reunies) to Tom Osdene (PM/USA principal scientist), "VdC Scientific Committee Meeting" (SCM), PM 2028524733 - 4736.

Influence of cigarette smoke on the DNA metabolism. It is Dr. Adlkofer’s opinion that the results of Dr. Altman’s study [in translation: Influence of cigarette smoke on DNA repair mechanism and on the chromosomes in spermatogenesis and red cell manufacture in hamsters] should be checked (reports sent only to T. Osdene.).... [Adlkofer has invited Dr. Preussman of the German Cancer Institute to speak on nitrosamines]: It is Phillip Morris’ opinion that there was no necessity to invite Prof. Preussman who’s [sic] attitudes concerning tobacco smoke and nitrosamines are well known. The VdC’s invitation is also in contradiction to the industry’s policy to avoid all public activities in the nitrosamine field at the moment.

* 6 June 1980, Pelz meeting notes report to Dembach, "Scientific meeting of the VdC (TFA), June 2, 1980." RJR 500926108 - 6109.

With representatives of the German Federal Health Office in attendance, reports were given by two invited researchers on nitrosamines - one indicating that it was a cancer risk factor in smoking (perhaps in combination with diet) and suggesting that cigarettes should have polycyclic aromatics, phenols and amines removed. The second scientist noted that "tobacco smoke is the biggest source of exogenous nitrosamines...the most versatile chemical carcinogens."

After the presentations, Dr. Fink of Philip Morris abstained from the discussion and Pelz withdrew.

The entire spectacle had been arranged in an attempt to show to the guests that Industry was concerned, that it was the Verband who could save Industry and to maneuver industry into an at least moral bind to do something.... The presentation was staged even though the VdC Board had recently rejected an article on nitrosamines [Hoffman’s] in the smoke of German cigarettes submitted for publication in Beitrage.

On ETS, the White/Froeb study of passive smoking in offices will be contested by various professors including Ernst Wynder.

# 2-13 June 1980, unsigned trip report by a British American Tobacco official, BAT (File no. B302 in Minnesota Depository) 105321117 - 1131.

Adlkofer attempting to create concept of a "safer" cigarette, citing Gio Gori’s approach at the National Cancer Institute.

He saw the need of the Industry as one of buying time, while independent scientists found ways to be publicists, in a P.R. sense, for "low risk" cigarettes.... Although Wynder accepted the Gori approach (and even used it on occasions), he still gave anti-smoking lectures, in order to maintain his credibility among medical authorities. It seems that Adlkofer gets a mixed reception from some of his member companies with US bases for his contacts with [Ernst] Wynder, who has acted as a consultant to the Verband.... Adlkofer added that Germany Government officials no longer trust the extreme anti-smokers and believe in the low risk approach. Politicians, on the other hand, are indecisive about whom to trust.

Report goes on to discuss nicotine as the driving force of "compensation" of low-tar cigarettes. Also discusses "tumorigenicity" [read, "carcinogenicity"] of nicotine:

I told him on a strictly confidential basis that we had strong indications from an incomplete mouse-skin experiment that tumorigenicity appeared to increase with increase in nicotine content. Adlkofer said that they Verband had made similar observations in a mouse-skin experiment by Brune.... Peter Lee has the interim results and Adlkofer gave me permission to obtain these from Lee. They showed that after 50-60 weeks, there was an increase in tumours in the group receiving the highest level of nicotine.... Adlkofer is obviously very concerned by this finding and, as a result, wishes to instigate a number of investigations of the effects of nicotine at the cellular level.

* 12 June 1980, Colby trip report to Timothy M. Finnegan (law partner in Jacob, Medinger and Finnegan), P.M. Schuler, Dembach (counsels), and Marcotullio, "Visits to German Research Grantees, Potential Grantees, and Related Contacts." RJR 500949802 - 9804, RJR 504821197 - 1200, RJR 500949809 - 9810.

Colby reports on ongoing projects mentioned in earlier reports. The previous three months required review time for all project approvals is now given as six months. Adlkofer asks Colby to comment on a letter Adlkofer drafted to the New England Journal of Medicine, criticizing the Froeb/White ETS study; Colby suggest a letter "by one or more German academic scientists" would be better. Colby notes that Prof. Jacob of Heidelberg gave the keynote address at the Anti-Smoking World Health Day -- and Jacob believes smoking causes lung cancer -- he had sent the draft of the speech to RJR-Germany, and that changes were made! "He was very unpleasantly surprised by the biased and one-sided interpretation of his remarks" by the media.

# 16 June 1980, meeting notes, Fink to Osdene, VdC SCM, PM 1000135116 - 5118.

"Beitrage zur Tabakforschung International" [the industry’s tobacco research journal]. The question was up for discussion whether the "Beitrage" should reject manuscripts which are in contradiction to the industry’s interests. Dr. Adlkofer stated that the "Beitrage" had to accept all manuscripts as far as they cannot be rejected for scientific reasons. The member companies delegates did not agree.... The general opinion was that each individual company should have the possibility to vote against a publication which is detrimental to the company’s interests.

* 16 July 1980, meeting notes VdC TFA, Pelz to Dembach, RJR 502740377 - 0379.

Adlkofer admonished never to bring outside guests in again (see meeting notes of 6 June 1980); the "vivid discussion" resulted in the deletion of material from the minutes of the previous meeting. Discussion about presence of pesticides in tobacco and cigarettes (maleic hydrazide).

# 12 August 1980, meeting notes, Fink to Osdene, VdC SCM, PM 1000122138 - 2141.

See note 11 March 1980. PM does not want Neurath’s figures on harmane/norharmane published because they are high.

* 2 September 1980, meeting notes VdC TFA, Pelz to Dembach, RJR 500880453 - 0456.

Document difficult to read, but continued discussions on various components of tobacco, including PAH (poly-aromatic hydrocarbons, a class of carcinogenic compounds) and nicotine as a cause of tumors on mouse skin painted with condensate.

Dr. Adlkofer said he knew of experiments that were done elsewhere in Europe that would support allegations against nicotine, but declared himself not to be in a position to reveal here.

# 19 September 1980, meeting notes, Fink to Osdene, PM 2028524723 - 4725.

PM and RJR rejected Neurath’s proposal to publish his harmane/norharmane data in "Beitrage" while Reemstma, BAT, Brinkmann, Austria Tabak approved. Industry statistician P.N. Lee finds that nicotine is a co-carcinogen (see note 30 October 1980) in the statistical analysis of the data. [N.B. The studies of Grimmer and Brune are mouse-skin painting experiments.]. Fink remarks, "In my opinion the German association is wasting money by projects like this.... [T]he results obtained very often turn out to be more detrimental than beneficial to the industries’ interest."

* 26 September 1980, Colby report to S.B.Witt, "Smoking and Health Research Projects in Germany." RJR 504821184 - 1191.

Colby describes "special projects," ones which are contracted and handled by the Verband but have been kept confidential from the old Research Council and the new Research Council. [N.B. Probably means the TFA, Tobacco Research Committee.]

The Verband has total control over the design of the experiments, the right of the researchers to publish.... These projects likewise need to be kept confidential to the outside (including CTR) excepting those having a ‘need to know’ within RJR, Philip Morris, Jacob & Medinger, and Shook/Hardy. These are the projects where we try...to achieve some consensus between Philip Morris and us.... Incidentally, I may have opened a somewhat better line of communication with PM on such projects, by talking directly to Dr. Tom Osdene (Alan Rodgman’s equivalent at PM) and/or Alex Holtzman.

The "special" and "confidential" projects included the following: 1. Co-carcinogenesis of nicotine (Colby deems the study poor and not publishable even though "a slight increase in carcinogenesis has allegedly been observed," with the statistical significance validated by Peter N. Lee "at best very limited"); 2. Determination of nitrosamines in sidestream smoke, reproducing earlier findings (Colby dismisses the results); 3. Presence of other mutagens in sidestream smoke (Adlkofer wants this study published, Colby and Pelz and PM opposed); 4. Compensation by smokers who switch to low tar-low nicotine cigarettes to achieve previous levels of intake (Colby is "adamantly opposed to this project on general principles" although Adlkofer, contrary to his earlier view, now wants to prove compensation exists). Ten other studies are mentioned, nearly all considered "worthless" or without "usable data" or "minor effects" or "questionable techniques" or "non-publishable" or "meaningless." The only study Colby finds worthy is one showing that smokers make more sperm than non-smokers.

Colby spends many words criticizing the planned compensation study by Dr. Schievelbein. "The full study and the preliminary study are ‘watergated’ with reference to purpose and grantor.... The study is represented to be dealing with fat metabolism and its alleged effect on cardiovascular parameters." [N.B. Colby used the term "watergated" to mean the industry concealing data.]

* 26 September 1980, Colby memo to Max H. Crohn (RJR in-house counsel), "Re: Public Smoking." RJR 503262709.

I have been informed on a confidential basis that there is a reasonable expectation for me to receive a paper by Dr. WYNDER, condemning the scientific validity of the White and Froeb study.... In all probability I will have the discretion to pass on this document to the Tobacco Institute for use as they may see fit, prior to the California Referendum. Confidential reliable information has been obtained that the chief expert of the German Government in the area of public smoking, a very well known Professor of the Free University of Berlin, also has written a paper, similarly condemning the scientific validity of the White and Froeb study, in response to inquiries from the German Parliament.... I am urging the German Industry Association to use their influence to have this inquiry and response expedited so that it would be used prior to the California Referendum.

[N.B. The paper by James R. White and Herman F. Froeb appeared in the New England Journal of Medicine in the spring of 1980, demonstrating that nonsmokers working in smoky offices had abnormalities of lung function similar to those seen in moderate smokers. White had been a major supporter of California Proposition 5 in 1978, which failed, and the upcoming Proposition 10, which subsequently also failed on the November 4 ballot. These propositions meant to restrict smoking in public places, restaurants and workplaces. The industry mounted fierce opposition through its front organization, Californians against Regulatory Excess (CARE). Letters of criticism of the paper written to the New England Journal of Medicine were similarly orchestrated, with authors like Gary Huber, Allan Freedman, Domingo Aviado whose paid links to the industry were not disclosed. Franz Adlkofer also had his letter published, though Colby had tried to discourage him -- see 12 June 1980 -- on the grounds that letters from persons not affiliated with the industry had already been submitted. See also Stanton Glantz, et al. The Cigarette Papers (Berkeley: University of California Press, 1996), 428-30.]

* 29 September 1980, Colby memo to S.B.Witt, "Tobacco Industry Sponsored Smoking and Health Research in Switzerland." RJR 503246621.

Comments on the "political" conditions in Switzerland, different from those in Germany, with respect to industry funding, so that researchers are quite independent. Nonetheless, Colby recommends the same basic structure as in Germany of funding and approval by tobacco companies through their Swiss Association.

* 6 October 1980, Colby memo to S.B. Witt, "Meeting with Dr. Herbert Bentley of Imperial Tobacco Ltd. Bristol/England -- September 9, 1980." RJR 500882657 - 2660

Bentley, once head of Imperial’s R&D, is identified as the "No. 2 man at Imperial,." second to Andy Reed. Colby discusses with Bentley "the basic political attitude of the British Industry management vis-a-vis their Government," and Bentley agrees, echoing Reed, that a firmer stance was needed. Colby notes,

The Industry has decided to stand firm against the Government’s demands on extreme control and/or reduction in advertising. The Industry believes that the Health Minister’s Sir George Young’s, extremist anti-tobacco industry stance will "in a crunch" not be backed by Margaret Thatcher who, according to "inside information", is for the Industry.

Colby urged the British industry not accede to or cooperate with the Hunter Committee demand that the Industry research "safer" cigarettes, and he pointed to the way the Verband had proceeded with its own Research Council [N.B. Colby refers to a 26 September memo to Witt on this, which has not yet turned up.] . Colby then passes on various bits of gossip, how Geoff Folton of BAT had been sidelined because he sided with S.J. Greene, head of BAT R&D who turned against the industry; Folton had called Colby a member of the "flat earth society." And Colby says of long-time Industry statistical consultant Peter N. Lee, "Peter was not only largely in agreement with the anti-smoking views of the British medical Establishment, such as Sir Richard Doll, but in addition to that, was from a technical point of view, not a very competent statistician." The Verband had recently hired Lee as their consultant.

* 10 October 1980, Colby report, "Compensation study." RJR 502741831 - 1832.

Colby complains about proposed Verband study seeking to determine if smokers switching to low tar/low nicotine cigarettes compensate to inhale the amount of nicotine they’ve been accustomed to. "I am adamantly opposed to this project... It is symptomatic that several years back the Verband was adamantly bent on proving that there was no compensation.... "

* 30 October 1980, Pelz meeting notes, "Scientific Committee Meeting of the VdC (TFA), October 30, 1980." RJR 501545704 - 5706.

Among other items, a discussion of whether BAT would do experiments on nitrous oxides in exhaled smoke at the Southampton. Committee felt CORESTA should not establish standards for determination of carbon monoxide and nitrous oxide, "and steps should be taken at Manila to prevent publication of methods."

Discussions on nitrates in exhaled smoke, nicotine as a co-carcinogen in mice, PAH, , and doubt cast on the NCI study begun in 1958 showing more lung cancer in smokers than non-smokers ("because of the similar smoking pattern of the control group [i.e. no lung cancer] evidence against a causal relationship...").

* 3 November 1980, meeting notes VdC TFA, Pelz to Dembach, RJR 500880306.

Discussion of the relationship between VdC and TFA. Adlkofer to stay as chairman of the TFA.

* 12 November 1980, Colby letter to B. Pelz, "Re: Minutes of the TFA meeting on October 8, 1980 - specifically ‘Inhalation - exhalation of NO/NO2." RJR 502740249.

Colby objects to any research on nitrates, possible carcinogen precursors in tobacco. "There is an abundant literature on NO -- and NO2 -- if any – in cigarette smoke.... In my judgment, this is just another example where the Verband artificially creates a problem where no problem exists."

* November 1980, meeting notes with a Dr. Biseld, Gesellschaft fur Reaktorsicherheit (a company determining the safety of atomic reactors), Pelz to Dembach,. RJR 502741939.

Biseld informs Pelz that tobacco plants take up from the soil and concentrate naturally occurring strontium 90 twenty to forty times the natural background. Biseld and Pelz seem to make common cause here.

This is an issue to them because tobacco is grown near the planned reactor at Rhyl and there is some danger that environmentalists pick this up and take it to court as they did with the enrichment of radioactive material by grapes. (The grape issue could be settled because the materials in question are removed during the yeast fermentation of grapes.) Dr. Biseld now wanted to know whether materials like Strontium would transfer from the tobacco into the smoke.... Dr. Biseld took the opportunity to ask me whether I could talk to the VdC on behalf of him. I promised to do so on December 4, 1980 (TFA meeting). Aside from this I think it would be a good idea to check our library whether we could provide him with any useful information concerning the transfer of heavy metals and certain radioactive isotopes, e.g. of Strontium, Cesium, Polonium, Plutonium.

# 20 November 1980, meeting notes, Fink to Osdene, VdC SCM, PM 2028524720 - 4722.

Now a study by Prof. Mohr indicates nicotine not a co-carcinogen (see note 19 September 1980). "Another DM 2000,000 wasted," writes Fink.

# 4 December 1980, meeting notes VdC TFA, Pelz to Dembach, RJR 502664410 - 4413.

In fact, the subject of Strontium 90 is not brought up until 8 April 1981. Professor Grimmer’s request for a grant to study PAH is revived, "because of a strong interest of the Verband to cooperate with Grimmer," but there would be a task force to determine the scope of the research needed "to reliably get an answer to the question of how nitrogenous compounds (proteins etc.) And nicotine would contribute to the formation of N-PAH." A study on the dangers of smoking while driving by Prof. Muller-Limroth (of the Arbeitsphysiologisches Institut) was discussed and new research on the matter proposed by the VdC; Muller-Limroth is consultant to the four million member German automobile club. Pelz remarks that "My feeling is that whatever the outcome of this research it will not weaken Prof. Muller-Limroth’s previously published warnings...."

A Coresta/TCRC Tabakkolloquim is planned and financed by VdC and Quester. Two guest speakers (Schievelbein and Baettig) will discuss "the importance of nicotine in cigarettes and its consequence for cigarette design, and the effect of nicotine on the human brain." Finally, a matrix of criteria for approval of proposed research is presented. The criteria are: Goal likely to be reached, scientifically sound, information under control, scientist sound, rating of importance, side benefits. [N.B. "Information under control" seems to have been the theme of the meeting.]

* 18 December 1980, Colby trip report, "Trip to Germany, Switzerland and Great Britain on Smoking and Health, December 1980." RJR 500949787 - 9791.

He sits in on the Verband TFA meeting as an "auditor," and criticizes the way Adlkofer runs the meeting. "It is, in my judgment, necessary to try find a way to remedy this." He also objects again to the compensation study.

In my judgment, however, it is imperative that the Verband receives unequivocal directives from the Executive Committee (composed of Mr. Fischer, Mr. von Specht (BAT-Germany), and other chief executives of the participating companies), not to make any commitment -- financially or otherwise -- on the full study, until ALL the results of the preliminary study can be assessed by the company scientists, for a minimum of about two months.... [Colby meets with a Dr. Harke, who had done studies on public smoking when with the Verband Research Institute, but who was treated] ...rather shabbily when the Institute was dissolved. Since Dr. Harke is a potential witness on public smoking, I have made a -- I believe -- successful effort to cultivate his friendship, by inviting him to lunch or dinner about once a year.

# 1981, no author, hand-written translation of Verband report on coumarin, RJR 511018368 - 8370.

Absolves coumarin:

If we disregard the erroneous reports on the carcinogenic activity of coumarin, then we can say, that coumarin does not cause any carcinogenic malformations, even with very high doses.... The permissible amount of coumarin use[d] (i/2000) lies below the absolute "no effect level[."]

.

# 5 January 1981, meeting notes, Fink to Osdene, VdC SCM, PM 2028524717 - 4719.

Further insight into Grimmer’s proposal to study N-PAH. He threatens to go to other institutions for support if VdC turns it down. He wants to correlate findings with lung cancer.

It is the VdC’s feeling that in order to control Grimmer and to prevent him from publishing results eventually obtained in the study and being detrimental to the industry’s interest we have to support the project.

* 15 January 1981, meeting notes VdC TFA, Pelz to Dembach, RJR 502664311 - 4312.

Discussions on how to go about researching PAH and N-PAH, a study on nitrosamines and diet (a Dr. Altmann finds smokers excrete less nitrosamines in the urine). Drs. Brune and Grimmer instill condensate into hamster throats [N.B. Recall the Dontenwill experiments that produced cancers, and perhaps led to his departure from the VdC laboratory], "This piece of research of the old Forschungsrat did not produce any useful results." On mouse skin painting experiment by Brune [see 19 September 1980],

Polycyclic aromatic hydrocarbons were shown to have no effect. The committee agreed that the VdC should not press for a publication of results because this might stimulate the researchers to search for other culprits.

# 12 February 1981, Report by Philip Morris scientist R.B. Seligman, "Surgeon General’s Report - Response." PM 2000515457 - 5462.

Discussing Industry responses to anti-smoking attacks,

Attempts in individual countries, e.g., CTR, TAC [UK], and the Verband unfortunately have tended to respond to issues nationally rather than internationally. This becomes increasingly ineffective when many of the attacks now are coming from international bodies like WHO, etc. Response must be global in concept because adverse reports from any country immediately have worldwide impact (viz.; -- Hirayama, Froeb/White, etc.). Thus, a major requirement would be to establish an international order or priorities because of the aforementioned synergistic and interactive effect of today’s rapid communications.

Seligman proposes a number of research studies to consider as part of the worldwide response: sidestream smoke, repeating the White/Froeb study; exploring the benefits of smoking; developing products "which are of low biologic potential;" reducing carbon monoxide; developing a "product with low ignition propensity"; and discussing a "reasoned approach" to additives with the Surgeon General. The last "may be of particular importance in the far distant future when we may contemplate the use of other nicotinoids or non-nicotinoics as flavorings, etc."

In conclusion, let us say that we are mindful of the potential risks inherent in conducting the proposed extramural studies. Perhaps, as scientists, our view of risk/benefit has been distorted by trying to do battle without armament. We feel, however, that the thrust of our antagonists’ position has been refocused to the non-smoker. Perhaps we should reassess our own risk/reward posture in this light.

# 19 February 1981 Colby memo to S.B. Witt, "Confidential." RJR 503681456 - 1457.

In meetings with Dr. Adlkofer and Dr. Koerner of the Verband, discusses prospective visit by Adlkofer and Peter Lee to Dr. Hirayama in Japan. [N.B. Takashi Hirayama published in the British Medical Journal in 1980 the first major study showing increased lung cancer in non-smoking wives of smoking men. Another study about the same time was published from Greece by Trichopoulos in the International Journal of Cancer.]

Also discussed was a possible symposium in Germany on public smoking. "The basic concept of the meeting would be to invite well known scientists who, as far, as the alleged effect of smoking on smokers is concerned, are not generally on our side, but who, on the other hand, agree with us regarding the lack of allegedly disease causing effects of smoking on non-smokers. In other words, this would include people like Drs. Wynder, Hammond and Garfinkel, and others." [N.B. Lawrence Garfinkel was vice-president for epidemiology of the American Cancer Society. His 1981 paper in the Journal of the National Cancer Institute showed equivocal results on second-hand smoke causing lung cancer, but in 1985 confirmed Hirayama’s premise with his second study in the JNCI. See Glantz, Cigarette Papers, 351.] "Towards the end of our conversation...I had a very successful -- though delicate-- discussion with Prof. Adlkofer on behalf of RJRTI on a matter which must remain confidential at this time."

* 20 February 1981, meeting notes by O. Stuhl (assisting Bernd Pelz from RJR-Germany) to Dembach, RJR 50266-4285, second page only.

Having attended the TFA meeting for the first time, I want to summarize some personal observations: 1. The general attitude of the VdC and other TFA members (except RJR) appears to be resignation vis-a-vis the anti/passive smoking issues. The willingness to even think offensively to me appeared to be rather limited. 2. Prof. Adlkofer exhibited a very authoritarian attitude in chairing the meeting, strangling discussions and avoiding decisions. His "soft handling" of "hot items" to me appeared to be more paralyzing than catalyzing. 3. Also I do not share Prof. Adlkofer’s opinion that about 90 per cent of the medical profession do believe in anti-smoking publications.

* 23 February 1981, Colby memo to Dembach, "A’s Hamburg statement on lung cancer - Conversation with him on February 16, 1981 in New York." RJR 511018345.

Adlkofer, referred to as "A" throughout the memo, is chastised by Colby in Ed Jacob’s office for a statement Adlkofer made to the Verband’s Executive Committee to the effect that "Smoking is the essential causal factor for lung cancer in addition to other factors," in the context of a discussion of Hirayama’s paper. Adlkofer indicated that while the American industry should worry about litigation, this was not a problem for Germany "for any time in the future." Colby then suggested strongly that Adlkofer stay on as secretary of the Forschungsrat [meaning the TFA] but give up his position as scientific director of the Verband. Adlkofer’s position was, in Colby’s view, incompatible with being scientific director. Colby intimates that this idea has support at top RJR levels.

* 27 February 1981, Colby secret memo to Dembach, RJR 500924216 - 4217.

Colby disturbed by the Research Committee intended to advise the industry on manufacture of its tobacco products, as well as Verband’s intention to reach out to industry-sponsored associations on smoking and health in other countries, like Australia. He also finds troublesome that Verband will seek to publicize itself, despite Verband-funded research that "seem to be designed to incriminate smoking."

# 3 March 1981, meeting notes, Fink to Osdene, VdC SCM, PM 1000119316 - 9317.

In vivo formation of N-Nitrosodimethylamine. The DMN level in the urine of smokers and non-smokers after taking a "standard meal" is significantly lower with smokers than with non-smokers. Does this mean that DMN metabolism in smokers works better than in non-smokers? This would be bad! [N.B. Suggesting that smokers are trying to detoxify the nitrosamines to which they have greater exposure.]

* 5 March 1981, monthly progress report, Stuhl to Dembach, RJR 500876340.

Continued orientation ("introductory training"). Mention of continued plans for research on N-PAH formation from nicotine.

A publication by Prof. F. Schmidt on the smoking habits of pupils was reviewed. In addition a brief summary on anti-smoking "education" and its consequences was submitted.

* 5 March 1981, memo from Stuhl to Dembach, "Austrian Anti-smoking Draft Regulations," RJR 500876356.

Attached please find a) an excerpt from a draft regulation on the protection of employees at the working place concerning the protection from annoyances caused by tobacco smoke. B) an information published by the Austrian Ministry of Health about planned regulations concerning tobacco smoking on trains. Both of these draft regulations, if ultimately passed, would lead to severe consequences for smokers.

# 12 March 1981, telex from Dembach and Stuhl to Colby, "Research project Dr. Winnecke," RJR 500875303.

Requests RJR approval to fund a study, "Molestation by tobacco smoke in individuals with differing sensitivity of smell." A hand-written note on the telex from RJR consel SBW (Samuel B. Witt) says, "Can WFD [Dembach] and FC [Colby] decide as long as within budget without otherwise [unreadable]... letters copying."

* 16 March 1981, Pelz memo to Dembach, "Adlkofer issue." RJR 500924173.

Report of comments made during a dinner meeting: Adlkofer had no ill-will to Colby who was just doing his job, but the idea to separate the positions as head of the scientific department of the Verband and secretary of the Research Council would not work as it attacked Verband policy.

A Prof. Kowitz of the Research Council, himself a smoker, indicated that smoking probably did cause lung cancer. Perhaps cigarette companies should sponsor courses on breaking the habit, without risk to the industry as "the effect of such courses would be negligible!"

* 18 March 1981, memo from Stuhl to Dembach, "VdC Board Minutes of Feb. 27, 1981," RJR 500876354 - 6355.

Discusses "predisposition" to respiratory and circulatory disease augmented by smoking.. Apparently Adlkofer supports the notion that people with low predispositions would need to smoke more to be diseased while people with high predispositions would be diseased at lower levels of daily smoking. Stuhl comments: "All attempts to quantify this alleged relationship between smoking and diseases have failed. Statistical data are no substitute for an experimental proof.

* 31 March 1981, monthly progress report, Oskar Stuhl (see 20 February 1981, Stuhl takes over from Pelz) to Dembach, RJR 502741927.

Stuhl getting oriented. Mentions a visit to the Research and Consulting Company in Basel, Switzerland.

RCC is a new independent commercial research institute that has been established by former industry scientists.... RCC has many outside consultants under contract (e.g. Dr. Chevalier, pathologist, who has worked in Dontenwill’s institute).

Also mentioned is a 20 March 1981 task force report of findings from a "Munich smoker study." [N.B. See 2 December 1981.]

# 1 April 1981, Colby memo to S.B. Witt, "INFOTAB - EC Task Force." RJR 503246709.

Opposes commissioning research on the addictiveness of nicotine. Instead, "I feel reasonably certain that it should not be too difficult to find prominent experts in the area of addiction who would write a ‘position paper’, clearly showing that smoking is not an ‘addictive drug’."

# 2 April 1981, Oskar Stuhl, meeting report, "Meeting of the N-PAH-Project Group...at the Verband der Cigarettenindustrie, Hamburg." PM 1003717566 - 7568.

Was nicotine a precursor of polycyclic aromatic hydrocarbons? "In view of the political and scientific importance of this project, the study should be kept strictly confidential. This could be ensured if the study would be carried out in a laboratory of the cigarette industry." Philip Morris to be approached to do the study in Richmond, Virginia.

# 3 April 1981, meeting notes VdC TFA, Stuhl to Dembach (inferred), RJR 502965409, 502664130 - 4131.

On N-PAH study by Grimmer, "The question of Prof. Grimmer’s honesty was subject of a vivid debate between RJR and Prof. Adlkofer." Adlkofer wishes to conduct PAH studies in Germany, replicating the study to be done at PM Richmond (see report of 2 April 1981). Stuhl comments, "My conclusion is that this proposal is to pave the way to a ‘VdC Laboratory.’" Continued discussion on nitrate studies by BAT, nitrosamines by Altmann, the impending final report on the "Munich smoker study,"

Prof. Adlkofer announced that a life long inhalation study on rats/hamsters is planned by the VdC to investigate whether acute or subacute metabolic alterations will occur. RJR asked whether nicotine shall be exonerated but condensate [tar] be incriminated. Prof. Adlkofer replied he did not want to palliate anything. Main purpose for VdC research is to exonerate nicotine, the main ingredient of tobacco smoke. The VdC research did not intend to incriminate condensate but, on the other hand, would not try to exonerate condensate.

* 8 April 1981, "monthly progress report," Stuhl to Dembach, RJR 502664239 - 4240.

The VdC will engage Dr. Grimmer to do parallel study on N-PAH (N-PAH II) to the one by PM in Richmond (N-PAH I), again with the imputation that Adlkofer wants a return to a VdC laboratory. "The Cadmium issue has been revived again." The Strontium 90 issue is brought up for discussion.

[Adlkofer and Grimmer] discussed a certain type of "barter deal": Prof. Grimmer is interested to do the N-PAH II research project for the VdC and he will then abstain from publishng brand names in an upcoming publication on the PAH spectrum (e.g. benzpyrene) of the top 10 German cigarette brands. He will furthermore stop his "balance and response studies" with the lung implantation model.

[On Strontium 90] there is some danger that environmentalists and alarmed tobacco growers pick this up and take it to court since information on this topic is publicly available.

* 11 May 1981, Colby memorandum for the record, "Discussion with Bernd Pelz on the meeting notes of the TFA meetings of April 2 and 3, 1981." RJR 502664132.

"We are, of course, dead-set against any attempts to set up an industry lab." Colby also opposes inhalation experiments with rats and hamsters, suspicious that the experiments will be manipulated to "incriminate condensate [tar] and exonerate nicotine." Colby wants to convince company representatives on the TFA of "the depressingly low scientific caliber of all the Verband projects, and of the...politically potentially embarrassing nature of the projects."

* 22 May 1981, Colby memo to S.B. Witt, RJR 512385360.

Translation of a memo by "Peter F. of Cologne." Dr. Adlkofer presented his research plan to the Committee of Chief Company Executives at the Verband. He included a large case-control study to "yield data for discussing the study by Hirayama," animal experiments with sidestream smoke, and analysis of sidestream smoke. Total cost about 2.5 million DM. The proposals were fully supported by Verband, and BAT with Philip Morris wanting to consult with their international associates.

* 1 June 1981, Pelz telex memo to Colby, RJR 500875551 - 5552.

Elaboration on the Verband meeting noted in 11 May 1981, citing Adlkofer and Koenig of the VdC. The wording all but indicates that passive smoking must and will be exonerated by industry-led research.

Critical scientists believe that there is little chance that the results obtained by Hirayama and Trichopoulos et al. will be confirmed..... The industry should have the possibility of a close cooperation concerning the set up of the questionnaire and the performance of the project itself.... Urging new hamster experiments with sidestream smoke: It is to be expected that the groups exposed to sidestream smoke will not deviate from the control groups as far as the tumor rate and life expectancy are concerned. For the performance of this project, an independent scientist should be won who might be able and prepared to stand for the results in public. Nevertheless, the industry must ensure the right to take part in the planning and performance of the project. On study of active and passive intake of smoke: From dosimetric considerations the conclusion may be drawn that a causal correlation between passive smoking and lung cancer is nearly impossible..... The performance of this investigation by a member company is recommended. The VdC-Board feels that the passive smoking problem can best be tackled by the industry itself by using all its means and efforts.

* 3 June 1981, Colby memo to S.B. Witt, RJR 503246679 - 6680.

Colby’s reaction to Pelz’s telex, cautious approval of the studies, although against industry collaboration with studies "being planned by our adversaries."

* 12 June 1981, Colby memo to S.B. Witt, "Plans for research laboratory of the ...Verband." RJR 502664848.

Adamantly opposed to a Verband "owned" laboratory. If Verband persists, he recommends RJR withdraw from all smoking and health research of the Verband.

* 12 June 1981, Colby memorandum for the record, "Re: Mr. Peter Lee." RJR 500879337.

Peter Lee, often an industry consulting statistician, had concluded that Hirayama’s study was correct. He warned an industry consulting statistician who reviewed the Hirayama study negatively, "not to be used by the Tobacco Industry." Colby informed Adlkofer "of this act of extreme disloyalty by Mr. Lee," who also consulted to the Verband.

Prof. Adlkofer said he was "shocked" and that he would question Mr. Lee next week on these developments, and also consider other measures. (Prof. Adlkofer informed me VERY CONFIDENTIALLY that he had in the past already some suspicions that Mr. Lee might have ‘leaked’ some confidential information he had received from the Verband to Dr. Peto and/or others of Sir Richard Doll and associates.)

* 17 June 1981, Colby to J. Giles, "Weekly Highlights." RJR 502665241.

There was an apparent attempt by the Verband to re-open its own laboratory (the Research Institute had been closed down in 1975). Colby indicates in his usual indirect language that it would not happen: "Potential plans of the German Cigarette Trade Association (Verband) of setting up their own research laboratories, were critiqued."

* 18 June 1981, Colby secret memorandum for the record and to M.H. Crohn and S.B. Witt, "Telephone conversation with Prof. Adlkofer." RJR 50087-9343.

Apparently Peter Lee was heard to make disparaging remarks about the Tobacco Institute, which would make his position as consultant to the Verband "untenable."

I told A also that I had been very dissatisfied with L’s performance in the past, since he used his professional knowledge and critical perception only in negative assessments of studies favorable to Industry points of view, and that I had never seen yet any similarly severe criticisms by L of studies alleging anti-smoking conclusions. [N.B. Review of several documents written by Peter Lee as found in various industry documents show rather the opposite.] We then discussed the visit which another of A’s secret emissaries, i.e. Dr. Gostomczek, had made last Monday (6/15/81) to White and Froeb. Gos. Is on his way back to Germany and will report to A. [N.B. Glantz, Cigarette Papers, p. 415, cites a Brown and Williamson memo 24 July 1981, Bates 00006- 42292-0002, J.K. Wells, corporate counsel, to Ernest Pepples, B&W vice-president for law, stating unequivocally that both Adlkofer and Lee accepted Hirayama’s data and conclusions. Adlkofer felt Tobacco Institute’s negative analysis was incorrect. The memo further described a 15 July 1981 Verband research meeting in which Adlkofer accused Tobacco Institute of attacking Hirayama even though TI staff knew his work was correct.]

* 23 June 1981, Pelz telex to Colby, RJR 504329766 - 9268.

Pelz recommends agreeing to a Verband laboratory on for completely approved projects by the TFA, and a guarantee that it will not lead to a permanent research laboratory associated to a tobacco company. Pelz’s reluctance based on the fear that findings will leak out to one or another company giving them competitive advantage, that industry findings are less credible than those of outside labs, and that the Verband might get into product development. [N.B. See "gentlemen’s agreement," 1 April 1963.]

* 1 July 1981, meeting notes VdC TFA, Stuhl to Dembach, RJR 502664766 - 4768.

Continued discussion of passive smoke studies in response to the Hirayama research. Discussion of VdC laboratory work on cooperative projects approved by TFA members, and guarantee that it would not lead to a permanent VdC research laboratory. Continued discussions on the kind of filter for measuring tar and nicotine, PAH formation, nicotine uptake from cigar and pipe smoking ("Prof. Adlkofer thought that such a project might be useful to exonerate nicotine."), report of Altmann’s nitrosamine study ("There was unanimity that the results did not add to existing knowledge, and the summary by Altmann did exaggerate the differences found."), a formation of the Cadmium task-force, and discussion of applying for permission to continue using coumarin as an additive.

Dr. Klus [Austria Tabakwerke] stated that he will be co-author of a planned review article "Sidestream smoke from tobacco products and indoor air pollution" by D. Hoffman (American Health Foundation) to be published in "Chemical Reviews". Dr. Klus would like to include the indoor air measurements of the VdC research project in the review as an exoneration of passive smoking. Dr. Klus expressed his willingness to be the "ghost writer" of a publication of the VdC results featuring Dr. Altmann as the only author. [N.B. Search of the journal Chemical Reviews from 1981 to 1998, and search of Medline, Toxline and Toxline 65 – 1965 to present – show several articles by D. Hoffman on tobacco smoke constituents, and several by H. Klus on nitrosamines and other smoke components, but no review on sidestream smoke such as promised above.]

# 6 July 1981, meeting notes, Fink to Osdene, VdC SCM, PM 1000122045 - 2050.

Discussion on setting up joint projects. Discussion on whether to publish the nitrosamine data, whose results in the sidestream smoke chamber seem lower than in publications by others.

Publishing would be useful as a counter argument, but "publication is a direct admission by the industry that passive smokers are exposed to nitrosamines."

* 16 July 1981, memo from Pelz to Dembach, RJR 510974881.

Thesis on hydroxyproline.... The Board approved the expenditure of 20-25000 DM for an M.D. thesis conducted under the supervision of Prof. Adlkofer. The Board did this by buying Prof. Adlkofer’s argument that the TFA could not influence the contents and scope of an M.D. thesis supervised by Prof. Adlkofer. This may be pleasing for Prof. Adlkofer but has to be seen as a clear devaluation of the TFA. The logical consequence is that Prof. Adlkofer can get any money for scientific projects without having to prove the scientific merit, provided he can persuade the Board members.

* 24 July 1981, memo from J.K. Wells (Brown and Williamson counsel) to Ernest Pepples (B&W counsel), "Interesting developments on the Hirayama matter," BW 0000642292 and RJR 521028583.

Dr. Adlkofer...has committed himself to the position that Lee and Hirayama are correct and Mantel and TI are wrong. They believe Hirayama is a good scientist and that his nonsmoking wives publication was correct.... Adlkofer [said] that the TI knew it and that TI published its statement about Hirayama knowing the work was correct.

* 28 July 1981, memo from Stuhl to Pelz and Dembach, "Asbestos – Court battle between the Asbestos Industry and the German Federal Environmental Agency," RJR 503246428 - 6429.

The asbestos industry was fighting against the government labeling asbestos "a severe health hazard." The influential newspaper, ‘"Der Stern" alluded to the finding by Selikoff that smoking increased the risk of asbestos-induced lung cancer.

In anticipation of likely attacks on cigarette industry I propose as a first step a) the possible consequences for the cigarette industry because of that legal action by the asbestos industry be discussed by the TFA and b) the Verband should prepare a pertinent documentation with special emphasis on exonerating smoking. [N.B. In the 1960s, Kent’s "Micronite" filter contained crocidolite asbestos.]

* 31 July 1981, Colby memo to S.B. Witt, RJR 50213-6566, "Re: Competition (?) To INFOTAB." [N.B. INFOTAB was an industry-sponsored information tracking and response agency, based in London, replacing ICOSI.]

Information has been received that a major international European tobacco retailer’s association and its German affiliate are planning an "international" information service on smoking and health. I have discussed this with Wilfried [Dembach] and we have agreed that Dr. Koenig from the Verband should be advised by Wilfried immediately in order to avoid unproductive "duplication" and/or potential embarrassments.

* 4 August 1981, partial of a 23-page memo from Stuhl to Pelz, RJR 500950059 - 0061

On a travel tour with Frank Colby through Germany, Belgium, Switzerland to meet RJR grantees. Discussion on ongoing research by Dr. Lock of Hamburg, and Dr. Oser of Berlin, both Verband grantees, claiming that lung cancer incidence in Germany had not changed over several generations; and that "weakness" of the lung due to precedent lung disease predisposed to lung cancer.

* 5 August 1981, Colby letter to Timothy Finnegan (Jacob, Medinger and Finnegan), RJR 504798179.

Alerts Finnegan to possible statistical flaws in Hirayama study analyzed by "a competent German statistician who is friendly to the Industry," but his connection would be compromised if the analysis were made public. Possible flaws: "...even a cursory examination indicates that there is a significant discrepancy in the case numbers between Table 6 and the other tables [N.B. There is no Table 6 in the 1981 Hirayama report in the British Medical Journal, volume 282:183-185!]. Also, through some unexplained ‘natural catastrophy’ some 66 ex-smokers, etc. have been swallowed up in Table 3. [N.B. Table 3 gives relative rates of non-smoking women’s diseases by husband’s smoking status; no smoker numbers are on this table. There were 346 deaths from lung cancer in all women followed prospectively over 14 years, 245 women were married, and of these 174 were non-smokers and 71 were smokers. Colby may have added 66 to 174 to get 240 (?) ]. I have reason to believe that...these and other discrepencies in the data could really be used to ‘explode’ the Hirayama ‘fairy tale..."

* 11 August 1981, memo Colby to Giles and Rodgman, RJR 503246659.

Comments on the Verband N-PAH study: "...this [project] is essentially to keep Prof. Grimmer appeased.... Grimmer is a very sloppy worker."

* 11 August 1981, meeting notes VdC TFA, Stuhl to Dembach, RJR 502663945 - 3947.

Discussion on a case-control study of passive smoking. RJR opposed inclusion of PN Lee (who had, essentially, vetted the Hirayama study). "Dr. Adlkofer emphasized his strong doubts regarding the feasibility of this study." Controversy also on Adlkofer’s desire to do passive smoke animal experiments and dosimetry study of sidestream smoke. The pipe/cigar nicotine uptake study will be designed. The idea came from Wynder. ("For what purpose do we have the VdC scientific staff when they need ideas from Wynder?" Stuhl asks.) Unspecified discussion on Strontium 90, and publications on sidestream smoke. A German firm named TKR will attend the next TFA meeting.

A task force consisting of Prof. Altman, Drs. Fink, Klus, and Scherer [VdC] will prepare 3 draft publications to be discussed and agreed upon in the next TFA meeting. The RJR conditions (3 publications, no publication in "Beitrage fur Tabakforschung", no indication of any involvement by the industry) will be regarded.

* 12 August 1981, meeting notes, Stuhl to Dembach, "Task Force ‘Animal exposure to sidestream smoke...", RJR 501545666 - 5668.

A 2-3 year study. Adlkofer wanted to use hamsters, RJR wanted to use rats. Adlkofer wanted to cite Dontenwill’s findings as "scientific proof that tobacco smoke constituents can induce cancer in the respiratory tract of this species." "RJR emphasized that reference to Dontenwill was not desireable." Discussion then went on to the mechanics of the research. Sidestream constituents to be analyzed included carbon monoxide, total particulate matter [i.e.,tar], nicotine, nitrosamines, nitrogen oxides, acrolein, hydrocyanic acid [i.e., cyanide gas], phenols, oxygen, carbon dioxide, nitrogen; along with various biologic measurements on the animals.

# 13 August 1981, meeting notes, Fink to Osdene, VdC SCM, PM 2028524702 - 4705.

Adlkofer wants to study nicotine uptake in pipe and cigar smokers because they have lower heart disease rates than cigarette smokers. If nicotine absorption is demonstrated it would help in "clearing nicotine of the suspicion of being responsible for initiating coronary heart disease with cigarette smokers."

* 21 August 1981, Colby memo to S.B. Witt, "Re: Potential inclusion of tobacco smoke in the official German tabulation of threshold limit values of allegedly health deleterious material occurring at the workplace." RJR 504437973.

A workplace sub-committee of the German equivalent of the U.S. National Research Council is considering setting standards for a number of chemicals that might cause cancer: acetaldehyde, freon, cadmium, and tobacco smoke. "I am well acquainted with the chairman of that committee, and he does not support the request [to consider tobacco smoke] -- considers it -

(off the record) nonsensical."

* 2 September 1981, Stuhl to Dembach, "Monthly progress report," RJR 502741925 - 1926.

Line mentions of various projects noted in the meeting notes.

* 8 September 1981, Stuhl to Dembach, meeting notes, VDC task force "Animal exposure to sidestream smoke," RJR 501546120 - 6124.

Agreement not to mention Dontenwill’s work. RJR holds out for rats, and only rats. "Because of these proposals Dr. Scherer attacked RJR to sabotage the ‘task force solidarity.’"

[N.B. One has to consider that RJR knew or thought that rats would be less susceptible than hamsters.] Discussion, without resolution, on whether all or some of the sidestream smoke analyses should be done only in company labs, not contracted out. RJR refused to use Research and Consulting Company of Basel, whose principal Dr. Chevalier had worked with Dontenwill.

* 10 September 1981, J. Anderson (RJR Legal Department Employee) memo (partial), RJR 503685724 - 5725.

Verband is moving into research on anti-smoking organizations in Germany. An interesting side comment is prospect of economists Herbert Stein and Milton Friedman working with the industry.

# 14 September 1981, meeting notes, Fink to Osdene, VdC SCM, PM 2024972375 - 2376.

PM objects to the cigar/pipe smokers’ study being carried out as doctoral thesis "because the results are not controllable by the industry."

* 16 September 1981, memo from Stuhl to Pelz, "Conduct of TFA meetings," RJR 503810028 - 0030.

The general attitude of the VdC scientific staff is that they are the Industry, that they know what is good for Industry and that everybody should be happy that they are defending the interests of the Industry.... It appears to me that Prof. Adlkofer regards the TFA as an entity which has to assist him (or better, to agree to his proposals) and not vice versa.... In the past the VdC have planned the projects by themselves.... In order to prevent this, the member companies agreed to take part in task forces which now outline the research projects. But, unfortunately, in those task force meetings, the VdC (i.e. Adlkofer) now try to suppress the proposal, questions or recommendations of the task force members.... It appears to me that the attitude of the other member companies is dominated by "laisser faire" or better: lethargy. Only one company (REEMSTMA) participates actively. The rest of the TFA members abstain from indicating their disapproval and stating their position (which they privately admit).... [I]n the TFA meeting of August 7, 1981, Prof. Adlkofer stated publicly that he believes in adverse health effects of smoking....

Stuhl recommends that Adlkofer be replaced as chairman of TFA by company scientists in 2-3 year rotations.

# 16 September 1981, meeting notes, VDC scientific Committee Meeting, W. Fink to T. Osdene, PM 1000121264 - 1267. [N.B. See cross-reference document 13 May 1988, PM 2024972374.]

Mentions the ongoing studies and project groupings: Case-control study ("Roe" named as adviser, not Rose); animal experiments; sidestream smoke analyses; theN-PAH project; smoking and spermatogenesis, the presence of Strontium-90, Cesium-137 and Radium-226 in smoke ("the radiation exposure of the smoker due to these radionuclides is insignificant"); nicotine in Burley cigarettes condensate correlated with mouse skin tumors. A final research project is mentioned on nicotine absorption by pipe and tobacco smokers: Adlkofer wanted the study to

help in clearing nicotine of the suspicion of being responsible for the initiation of coronary heart disease with cigarette smokers...and suggests the sponsoring of a doctorate thesis. AUS, REE and BAT agree in carryiung out the project and to Dr. Adlkofer’s suggestion. PM rejects the suggestion that the project be carried out as a doctorate thesis because the results are not controllable by the industry.

# 16 September 1981, Colby memo to Jay Giles, RJR 500927334.

With lawyer approval, Colby will share with Verband the design of the new Industry project with Battelle Memorial Institute (Columbus, Ohio) on environmental nicotine and other sidestream constituents. [This was one of several "Special Account 4" research projects with money provided directly by Jacob, Medinger and Finnegan law firm; other special project accounts were similarly funded through law firms. Battelle received $69,000. Between 1976 and 1993 forty-nine research projects and twenty-three consultancies on environmental tobacco smoke were funded. "Tobacco industry-sponsored reviews published in symposia consistently favor the industry’s position that tobacco is not harmful." See Glantz, Cigarette Papers, 305-7, Table 8.1.]

* 17 September 1981, Colby secret memo to S.B. Witt, RJR 50364-6776 - 77, "Re: German closed workshop and prior scientific publications of public smoking: research concept of public smoking case control study." RJR 504437973.

Colby indicates that the planned Verband symposium on public smoking may not be held after all, but if it is,

it will be a completely closed meeting by invitation only, chaired by Drs. Valentin and Wynder.... The thrust and intent of the meeting would be to convince as many German, other European, U.S. and other scientists that, with reference to public smoking, there is no real controversy, and that the facts on this problem are all on our side.

Colby also tries to dissuade Adlkofer from his case-control study ("next to impossible to achieve").

* 17 September 1981, S.B. Witt telex (RJR in-house counsel) to W. Dembach (RJR German counsel), RJR 500924202.

Another, and more doubtful perspective on the proposed Verband symposium on public smoking: "Understand from FGC[olby] that Verband discussing internally possibility of new Munich public smoking symposium, to be held privately, and to which authors of recent papers unfavorable to our position may be invited, with the intention of discrediting them."

# 20 September 1981, memo from Bernd Pelz to H.J. Weder, "Direction of Verband research." RJR 500875313.

Pelz worries about independent Verband research into sidestream smoke, abetted by BAT, to further Adlkofer’s goal of producing a "safer cigarette."

What worries me, is the new direction the VdC research is taking. By this I do not only mean that Prof. Adlkofer’s declared objective is still to conduct research primarily such that it will promote a less harmful cigarette, but that he seems to have found a new way to organize his effort: I am talking about the newly established task forces of Industry scientists, and the recent use of Industry laboratories for VdC research. Projects run under this regime are the study run by BAT on the inhalation/exhalation of NO/NO2, the study on N-PAH formation from certain precursors (PM), and three new projects on public smoking and sidestream smoke composition.... All in all, I think, we should review as a Company whether we can and want to identify with what the Verband is doing, and how RJR could appear and act in a more monolithic fashion towards the Verband.

# 24 September 1981, meeting notes, Fink to Osdene, VdC SCM, PM 1000118745 - 8747.

Prof. K. Ueberla (President of German Federal Health Office) criticizes the planned-for case-control study (recommended by international experts). There may have been a conflict here with Ueberla’s project design. In light of Hirayama’s passive-smoking study, the Federal MAK list ("maximum permissible concentration of noxious compounds") is proposed to include passive smoking. VdC asked to comment on the proposal.

* 13 October 1981, Colby draft report to S.B. Witt, RJR 500875211 - 5216.

Colby reviews RJR research projects in Germany. Recapitulates three kinds of research projects: RJR-fully funded - kept secret from Verband until published; Verband-funded through the Forschungsrat (or TFA), presided over by Prof. Schmaehl of the German Government Cancer Research Institute in Heidelberg -- mostly nicotine-oriented; and directly funded by Verband, confidential contract research. Ostensibly RJR has a major say over the first and third. The Forschungsrat research "is supposedly totally independent of Industry influence, except for its general theme." Colby has little good to say of the latter. The project descriptions are little different from the report of 26 September 1980.

There is little doubt in my mind that modest as our effort is, the quality of our research is better than that of the Verband, even though this may only be because of the lack of quality of their research. This, however, encourages me to suggest about a doubling of our German research budget.

* 22 October 1981, Colby memo to Witt, "Re: Article on legal aspects of public smoking in Germany." RJR 504311909.

Judge Juergen Geschwinder published an article in "Medizin Mensch Gesellscahft" advocating banning public smoking to protect non smokers from "bodily injury." Colby criticizes Verband for not having known of the article even though it had been out for at least a month.

* 23 October 1981, meeting notes VdC TFA, Pelz to Dembach, RJR 503248654 - 8356.

Decision not to do a case-control public smoking study (i.e., passive smoking effects), to use both rats and hamsters in the animal study, Pelz grumbles that Adlkofer is pushing for decreasing nitrosamines through Preussmann of Heidelberg who was sent to a Tokyo conference on the matter in industry money.

* 28 October 1981, meeting notes, Stuhl to Dembach, "Animal exposure to sidestream smoke," RJR 505741692 - 1694.

Very poor reproduction of document. Francis Roe, English BAT consultant and pathologist, is present. He noted that more biologic data are known for rats, but that in focussing on cancer, "hamsters were the most [unreadable] rodent species for that purpose." But he understood the Industry position that repeating the Dontenwill design as a "positive control" would be "misinterpreted and would then be regarded in the scientific world as accepted by Industry." Roe made no further mention of a "positive control" (i.e., Dontenwill’s design).

[N.B. A recent review by Stephen Hecht ("Tobacco Smoke Carcinogens and Lung Cancer," J Natl Cancer Inst 1999; 91: 1194-1210) indicates that the hamster larynx is the "most reliable [model] for induction of tumors by inhalation of cigarette smoke," while experiments with rats and mice give inconsistent results.]

# 2 November 1981, H.J. Weimann report to Philip Morris, "Meeting of the N-PAH-Project Group on 2nd November 1981 at the Verband...." PM 1003582423 - 27.

Present at the meeting included Prof. Adlkofer, Drs. Fink (Philip Morris), Jenkins, Kaussman (Reemstma), Osdene (Philip Morris), Stuhl (RJR-Germany), Weimann (Verband staff scientist). Philip Morris USA a major collaborator in the study.

* 2 November 1981, Stuhl to Dembach "Monthly progress report," RJR 501015568 - 5569.

Reiterates the 28 October notes. Plans to develop an industry-sponsored Swiss Research Council put on hold but that independent Swiss scientists would be asked to review VdC research protocols; it would be a way to recruit them to such a council if they were willing.

* 4 November 1981, meeting notes "N-PAH task force of the TFA," Stuhl to Dembach, RJR 501015436 - 5437.

Phase I to study whether nicotine contributes to N-PAH formation. If so, Phase II would determine which ones. Study with radioactive carbon-14 labeled nicotine. A labeled marker N-PAH was needed; Adlkofer thought he could obtain it from D. Hoffman (At American Health Foundation) or from Hirayama’s boss at the Japanese Cancer Institute. "RJR heavily opposed and strongly recommended not to contact any opponent of Industry since otherwise the secrecy would be jeopardized. PM promised to look for a labeled marker substance (possibly through unofficial contacts via NCI)." [N.B. Here someone has underlined the last parenthetical remark and put an exclamation mark in the margin.] Stuhl comments:

It now appears to me that this has become a "closed shop" project, i.e. a project that is exclusively handled by PM and the VdC scientific staff since Prof. Adlkofer praised that PM will pay 60% of the costs for this project themselves; Dr. Fink [PM/Neuchatel Fabriques Tabak Reunies, FTR] and Dr. Weiman [VdC] will from now on be the representatives of the N-PAH task force.

# 12 November 1981, meeting notes VdC TFA, Stuhl to Dembach, RJR 501546103 - 6106 (unreadable), RJR 503248637 - 8640 is the same, readable, misdated on the website as 11 December, with first two pages coming last in the Bates sequence.

A German company named TKR was invited to meet the group. According to a letter by Frank Colby to Jay Giles (* 13 August 1981, 501965978), TKR was "allegedly founded by some German physicians for the purpose of a quick gain, or failing that, a profitable tax write-off." He dismisses them as charlatans. Stuhl notes that TKR proposes to reduce the harmful effects of cigarettes by adding urea to reduce nitrosamines and benzo(a)pyrene [BaP]. They seemed naive, not realizing that urea was already being added to tobacco in France and Belgium. Prof. Adlkofer made the following comment:

We [i.e. VdC and Industry] don’t hold the view that current PAH levels in cigarettes should remain as they are.... We hold the view that BaP is carcinogen but we assert that BaP alone does not give an important effect. Therefore we hold the view that, as far as carcinogenicity is concerned, there must be other substances in tobacco smoke.

* 18 November 1981, Colby secret memo to S.B. Witt, "Re: Suggested funding for RJRT- GmbH/Cologne grants for smoking and health research in Germany." RJR 503247144 - 7146.

Requests help in getting approval for a doubling of the RJR direct grant program, $350,000 per year. The funds are for continuation of all the previously listed projects, with one addition, "relationship between stress and cardiovascular impairments in blue collar workers with special reference to smoking."

20 November 1981, telex from Colby to Pelz, RJR 502741932 - 1933.

Congratulates Pelz on Verband’s study showing less nitrosamines in smoke than Hoffman did, "of about one half to one order of magnitudes less than Hoffman." Discusses which prestigious journal this could be published in.

* 2 December 1981, meeting notes, Stuhl to Dembach, "Munich smoker study," RJR 502664785 - 4787.

200 male students were enrolled in this pilot study. "Data obtained in the pilot study cannot conclusively be interpreted." They smoked cigarettes with nicotine levels between 0.8 to 1.5 mg. Nicotine and cotinine levels in the blood and urine showed enormous inter and intra-individual variance. Study did not control for puffing behavior. It is hard to discover from these documents what the purpose of this study was. Stuhl comment in the same vein:

Prof. Adlkofer stated several times that he would have never expected results like this...and that he now had learned quite a lot. I think it is not the role of Industry to finance Prof. Adlkofer’s learning processes, especially when one remembers that objections regarding the conclusiveness of results were expressed before the pilot study had been initiated.

* 3 December 1981, memo from J.A. Giles to Dr. Ray . Morse, "Support of medical research." RJR 500534362.

If Colby’s plans are to be implemented it should emphasize grants to highly qualified scientists, no up-front bias, peer review of proposals and results, more evaluation by RJR and outside consultants.

* 8 December 1981, meeting notes, Stuhl to Dembach, "TFA task force ‘Determination of sidestream smoke constituents,’" RJR 502664781- 4784.

This was a meeting over dinner. Decision taken to include nickel and polonium-210 in analyses. Companies divide up the analytical work. Weiman of Austria Tabakwerke kept pushing for a private firm, Austratom, to do the polonium-210 measurement to which RJR objected.

Stuhl is beside himself:

This was the worst and most erratic dinner meeting I ever attended. It is a complete impossibility that Drs. Ball [Reemstma] and Weimann were accompanied by their wives who attended the entire meeting and thus had an opportunity to listen to details of this highly confidential project.

# 9 December 1981, meeting notes VdC TFA, Stuhl to Dembach, RJR 501546073 - 6075.

Poor copy. Board agreed to reconsider the animal sidestream experiment because of cost, and whether the experiment had value from a public relations point of view. The Board had decided against an epidemiologic study of passive smoking (either case-control or prospective). Adlkofer prevailed on them to let Dr. Ueberla restudy the matter. It appears that the VdC TFA was willing only to find one answer:

Since Prof. Adlkofer was totally convinced that the attitude of Prof. Ueberla was positive towards passive smoking and that Adlkofer would get an exonerating statement from him in advance, the discussion stopped."

A report on carbolines in cigarette smoke was distributed, but no summary is given. A blind study of umbilical cords and placentae of smoking and non-smoking mothers showed no differences but the study details were not available. [N.B. But see 3 July 1979.] An unspecified study by a Dr. Baettig of the Scientific Commission of the Swiss Cigarette Manufacturers (ASFC) is tabled for further discussion.

* 15 December 1981, Colby memorandum to record, telephone discussion with Dembach, RJR 502665138.

Wants detailed input for the statutes of the Third Forschungsrat about to be convened.

#18 December 1981, meeting notes, Fink to Osdene, VdC SCM, PM 1000118328 - 8330.

Fink’s minutes on the umbilical cord study say, "Umbilical cord transformations cannot be related to smoking." A case-control study on passive smoking cannot be carried out by the Verband because of cost. Fink comments: "The industry with a PR-budget of DM 300 million can hardly argue about project costs."

# 19 December 1981, meeting notes, Fink to Osdene, VdC SCM, PM 2028524693 - 4694.

A manuscript on dimethylnitrosamine in the air of smoke filled rooms by the Austrian Research Centre Seibersdorf is "revised by the editorial committee" and will be used to respond to the proposed MAK listing of passive smoke.

* 28 December 1981, Colby memo to S.B. Witt, RJR 503247506, "Re: German study concludes no increase in cancer mortality for the last one hundred years -- a RJR grant. Follow up."

Dr. Lock allegedly said that while there are important reasons why smoking might be involved in lung cancer, the concept that lung cancer has increased in epidemic proportions is not correct, since it fits into the total concept that overall cancer incidence has not increased -- according to his Hamburg data -- over the last about one hundred years.

[N.B. According to figures from WHO, Tobacco or Health: A Global Status Report (Geneva, WHO, 1997), p. 314, lung cancer mortality in German men rose from 30 per 100,000 in 1952 to about 75 per 100,000 in 1993, peaking in 1985.]

* 12 January 1982, meeting notes VdC TFA, Stuhl to Dembach, RJR 502663853 - 3854.

The Munich smoker main study put on hold. Nicotine uptake by cigar/pipe smokers to be funded. Dr. Baettig’s study is not understood by the TFA despite its presentation (no details given here). The manuscript on nitrosamines in public places is still being modified. The carbolines study by Dr. Neurath was not completed, "a supplementary study will be initiated in the very near future."

* 22 January 1982, memo (partial) from O. Stuhl to Pelz, RJR 50201-5706.

1) Austria [Austria Tabakwerke AG, member of Verband] has "totally adopted the concept of the allegedly ‘less harmful cigarette’. 2) This agreement goes far beyond the concessions made by the British Industry. 3) Austria will from now on be the main ally of the Verband since Prof. Adlkofer had admitted to me that he is endorsing this concept entirely; especially Dr. Klus, TFA member of Austria will now be much more pro-VdC than he had already been before.

# 27 January 1982, research report, unsigned, "Pilot study for large scale Verband exercise," BW 650330318 - 0352.

Detailed presentation of the pilot for the "VdC field study about smoking behavior," involving 200 men 18 to 40, measuring smoking patterns, biological tests of intake, butt length, personality. 60 persons had a constant high serum cotinine level, 45 with "constant medium" level, 44 with constant low levels, 9 with fluctuating levels. "Light" cigarette smokers compensated, stronger cigarette smokers under-compensated.

* 5 February 1982, monthly progress report, Stuhl to Dembach, RJR 503246199 - 6200.

An update on cadmium from Prof. Korte (Institute for Ecological Chemistry) indicating that 3-pack a day smokers took up more cadmium from tobacco than from food.

* 5 February 1982, meeting notes at the "Tobacco Research Institute in Forchheim," Stuhl to Dembach, RJR 503246160 - 6161.

An upcoming publication by Drs. Fischer and Schmidt (of the Tobacco Research Institute)

on Strontium 90 and Cesium 137 in tobacco and cigarette smoke. No details are given on the findings. However,

Dr. Fischer informed the participants that he had determined the levels of various radioactive elements such as uranium, plutonium, radium, in tobacco...which he would like to publish. RJR suggested that – in case of publication – for a balanced paper the levels in several vegetables should be included as well.... Regarding the levels in tobacco, Dr. Fischer had to admit that these are just above the detection limit.

* 15 February 1982, meeting notes of the "N-PAH task force of the TFA," Stuhl to Dembach, RJR 501016046 - 6047.

"Prof. Grimmer had no conclusive results after 6 months of work.... Prof. Grimmer’s preliminary results appear rather poor, contradictory and questionable.

# 15 February 1982, meeting notes, Fink to Osdene, VdC SCM, PM 1000118446 - 8448.

Results of the Munich Smoker Pilot Study: Based on nicotine [cotinine] levels with 157 "cigarette-only" smokers, 60 have high levels, 45 medium, 43 little or none, 9 varying from high to medium.

* 16 February 1982, Colby memo to S.B. Witt, "Re: Posible German legislation curtailing smoking at the workplace, and other developments on public smoking." RJR 502665433.

The German Ministry of Labor and Social Order drafted a law that included this mild provision: "The employee can request from the employer that he take measures that other employees do not smoke near his workplace in a manner which may be annoying."

Colby advises:

The Verband is, of course, endeavoring to prevent such a law, or, and more specifically, that particular paragraph.... Please note that the paragraph does not have any health references, but it is a clearly dangerous, possibly precedent-setting situation.

*18 February 1982, meeting notes VdC TFA, Stuhl to Dembach, RJR 501546041 - 6042.

Baettig’s project is identified: "Whether there are factors other than nicotine which cause smokers to smoke." PM, RJR, BAT, Austria approve, Brinkmann and Reemstma hold off. They want him to use cigarettes without nicotine as a control.

* 18 March 1982, Colby to S.B. Witt (in-house counsel), RJR 50053-4185.

Industry scientists are kept on a very tight leash.

I have been informed that Dr. Seehofer, Research Director of BAT (Hamburg, Germany), has, in principle, accepted an invitation to give a lecture on smoking and health during the meeting of the German Chemical Society... Dr.Seehofer allegedly will review his lecture prior to delivery with the standing committee of the research scientists of the member companies of the Verband. I am wonder whether or not Ernie Pepples [Brown and Williamson VP and General Counsel] has been informed.

* 19 March 1982, memo from Stuhl to Dembach, "Wiessler Project," RJR 511074310.

Allusion is made to minutes of a 4 March VdC TFA meeting, a document not located.

However, the Dr. Wiessler mentioned, from Heidelberg, studies nitrosamines (see RJR 504118088, 514890721, 508725672). "Dr. Colby shares my view that the approval procedure for this project (as described in the meeting minutes of the VdC Board meeting, March 4, 1982) is likely to cause problems for Industry."

* 24 March 1982, Colby memo to Pelz and Stuhl, RJR 504339785.

Complains that Verband mainly critiques studies "which demonstrate an objective or sympathetic attitude towards the industry."

# 24 March 1982, unsigned memo, "Smoking and health coordination ‘Verband’ research/Germany." RJR 501015327 - 5329.

A review of how Verband conducts research, and lack of coordination with the Industry in its world-wide position, and RJR’s options.

It is felt that the head of the Scientific Department of the "Verband" [Adlkofer] is not entirely sharing the scientific view of member companies on fundamental aspects of the smoking and health controversy. Considering his accountability as the spokesman of the industry vis-a-vis the scientific community, his personal view – if and when expressed towards scientists in Germany and abroad – might weaken/counter/endanger the industry’s position on smoking and health aspects.... We can see the following options for RJR: 1. Live with the current situation (laissez faire/be nice approach – Philip Morris attitude). 2. Improve current situation by playing an over proportionate, active role in structuring, designing and supervising research work. This includes efforts to reposition the function of or even replace the current head of the Scientific Department of the "Verband". 3. Discontinue our contributions to the industry research, both in terms of funds and input, excluding "Forschungsrat". 4. Discontinue any support to the "Verband" for all kind[s] of scientific research, including "Forschungsrat"

Author appears to advise option 2. "In this context it cannot be excluded that [Adlkofer] will become a risk factor for the industry." [N.B. Wonderful use of the term "risk factor," the Industry’s code term for the link between smoking and lung cancer.]

* 25 March 1982, memo from Stuhl to Pelz, "Coumarin study conducted for BAT under supervision of the German Federal Health Office (BGA)," RJR 503246271.

Complains about the unrealistically high dose used in the study, which apparently gave liver damage to the test animals.

* 26 March 1982, Colby memo to S.B. Witt, RJR 51075-0129, "RE: German coumarin research."

In 1980, BAT-Germany commissioned a study on biological effects of coumarin, a commonly used flavoring additive in cigarette tobacco. RJR went along with project, "especially since RJR had requested from the German Health authorities an authorization to use coumarin in our German products." Colby withdraws support from the project, attacking the researchers as incompetent. Apparently the study showed adverse health results with doses Colby called "excessive." [N.B. From Glantz, Cigarette Papers, p. 221-22: "Coumarin, which imparts a vanilla-like flavor...was used as a food and tobacco additive for many decades. It was especially valued by tobacco product designers as a flavor booster in low-tar brands. Most commercial use was abandoned when it was discovered that coumarin caused liver damage in both rats and dogs and was suspected of being carcinogenic." Germany allowed coumarin in German brands as long as the earlier animal studies were repeated. ]

# 30 March 1982, meeting notes, Fink to Osdene, VdC SCM, PM 1000118081 - 8085.

A nicotine aerosol generator developed by the Fraunhofer Institute (see note 29 October 1982) allowed small animal passive smoke experiment; their blood showed the levels found in heavy smokers.

* 1 April 1982, meeting notes, "Munich smoker study task force meeting," Pelz to Dembach, RJR 503643011.

Discussion of an expanded study, whose purpose is "the question whether smokers keep their nicotine uptake constant over a longer (6 months) period of time."

* 2 April 1982, meeting notes VdC TFA, Stuhl to Dembach, RJR 503643004 - 3006.

Concerning the planned animal experiment a vivid discussion arose over our proposal not to use hamsters as an animal model, and our unwillingness to support a hamster study.... Prof. Adlkofer said that then the VdC Board would have to decide on whether or not to use rats only.

RJR continues to object to Adlkofer’s passive smoking dosimetry study. A task force to be formed to study the proposal.

* 6 April 1982, memo from O. Stuhl to W. Dembach, "Monthly progress report." RJR 501015260 - 5262.

Demonstrates how closely each company tried to control Verband-sponsored or suggested research.

"In the TFA meeting February 18, 1982, Austria, PM, BAT and RJR agreed to this project whereas Reemstma and Brinkman only promised to announce their decision later....The VdC Board approved a research proposal by Dr. Wiessler, a co-worker of Prof. Schmaehl, to be conducted as VdC research. Initially, Dr. Wiessler had intended to apply for a Forschungsrat grant but Adlkofer regarded a VdC grant more efficient to improve the ties to Prof. Schmaehl. Dr. Colby and I think this procedure is likely to cause problems for Industry."

See also September 1977 memo from Colby, * RJR 502741197, "I have very serious objections against Prof. Schmaehl.... I used to believe in Prof. Schmaehl’s integrity, but due to some incidents you are aware of I had to change my mind. The only point in his favor is that he probably can be influenced to some extent."

* 8 April 1982, report from F.J.C. Roe (scientific consultant) to Don Hoel (Counsel with Shook, Hardy and Bacon), PM 2501025251 - 5254.

Francis Roe is described in the Philip Morris document title as "employee." He served BAT for many years as a consultant, especially on passive smoking but also on a broad range of health issues. Obviously, he worked both sides of the Atlantic. Here he advises against further animal research of the kind Verband contemplated, exposing rats to side-stream smoke, particularly because [unlike humans],

Laboratory rodents do not convincingly develop lung cancer, emphysema or heart disease in response to exposure to mainstream smoke.... There is more to passive smoke than simply exposure to side-stream smoke.

Roe also advises the [Tobacco Advisory] Council and public relations staff not to believe that the passive smoking issue is simply unfounded and could be proved so by better industry research.

Before I embarked on this review, I quite expected to find in the literature an abundance of evidence pointing to there being a very wide "safety margin" between maximum passive smoke exposure under realistic conditions and active smoke exposure. I am now rather concerned that this expectation has not been fulfilled in respect of several smoke constituents, particularly vapour phase constituents and particularly constituents that are more abundant in sidestream than main-stream smoke, e.g. oxides of nitrogen, acrolein, ammonia, carbon monoxide, dimethylnitroasamine, nitrosopyrrolidine. This would seem to mean that the lowness of the levels of uptake by passive smokers of a smoke constituent, such as nicotine, cannot be extrapolated to provide reassurances that exposure to other smoke constituents is ‘negligible.’

Such an appraisal of the situation is totally unrealistic. It is not going to be possible to show that non-smokers are at no risk and agreement on what level of risk may be regarded as ‘negligible’ is for politicians, not scientists, to settle. The most that scientists can provide is a basis for estimating levels of risk and for viewing them in perspective.

* 13 April 1982, Colby memo to S.B. Witt, "RE: Use of hamsters as a second animal species in potential German cigarettes Industry project on public smoking -- Difference of opinion with Tim Finnegan." RJR 503246640 - 6641.

Lawyer Finnegan (Jacob, Medinger and Finnegan) asked Bernd Pelz to oppose use of hamsters in addition to rats in passive smoking study. The reason is that "excessive smoke inhalation may result in allegedly near malignant lesions in the larynx of...hamsters." Colby thinks the results were "favorable from an industry point of view," because the hamsters didn’t get lung cancer. Also, eliminating the hamster model may be a public relations error, allowing critics to say the industry was rigging the data. But there was another problem. W. Dontenwill had been pensioned off at age 50 and the Verband Research Institute closed in 1975 because Dontenwill had published results showing laryngeal cancers in hamsters inhaling smoke. If hamsters were not used in further experiments, other results in hamsters apparently favorable to the industry could not be cited:

"Discrediting" the hamsters for smoke inhalation experiments makes it impossible, or at least very difficult, to cite data that show cigarette smoke inhalation to very significantly extend the lifespan of hamsters, compared to non-smoking hamsters (Wehner, Battelle Northwest).

* 15 April 1982, meeting notes "Meeting of the TFA taskforce ‘Determination of sidestream smoke constituents," RJR 504339780 - 9781.

Still no decision on who will supply the blends for the specially manufactured cigarettes by RJR. RJR still resists measurement of Polonium-210 in an outside laboratory (obviously can’t be done in an Industry laboratory). Miscellaneous items included a statement on a CTR (Council for Tobacco Research) funded study on mice inhaling smoke. "Diverging viewpoints became evident."

* 20 April 1982, Colby memo to S.B.Witt, "With friends like this, we NEED enemies -- Polonium -- lung cancer -- Pro. Adlkofer." RJR 51221904.

Colby wryly notes a letter Adlkofer wrote to the New England Journal of Medicine hypothesizing that radio-active polonium, a contaminant of cigarette tobacco (introduced through fertilizers), might be a cause of lung cancer. In this case, Colby favorably quotes the Surgeon General’s Report of 1979, which did not credit polonium with such a role.

* 21 April 1982, Colby memo to Jay Giles (RJR scientist working in the legal department),"Weekly Highlights." RJR 502665312.

Confidential information has been obtained that Dr. Wynder and associates are doing a study on public smoking among patients of diseases alleged to be associated with smoking. A memorandum has been written on a deplorable statement by the Scientific Director [Adlkofer] of the Verband on polonium and lung cancer.

[N.B. Wynder’s study was published: Kabat GC, Stellman SD, Wynder EL, "Relation between exposure to environmental tobacco smoke and lung cancer in lifetime nonsmokers." American Journal of Epidemiology 1995; 142: 141-8. The study of non- smoking men (41) and women (69) with lung cancer were compared to matched controls. No statistically significant difference in exposure to passive smoke was found (odds ratios 1.6 and 1.08 but confidence intervals below 1.0) The study is not quite like Hirayama’s and, later, Fontham’s, in that not all the cases were married to smokers, and the exposure took place in many settings, which could dilute the results. Nonetheless, the result probably persuaded Wynder that passive smoking was not an important problem as far as lung cancer was concerned.]

* 23 April 1982, meeting notes, "Annual meeting of the Coresta Pesticides Sub-group in Amsterdam," Stuhl to Dembach, RJR 504159274 - 9277.

Discussion on which pesticide residues in tobacco to be measured: although aldicarb (an extremely toxic insect pesticide) was found, "a foolproof analytical method...could not be developed," so it was dropped from consideration. Ridomil (mancozeb, a not acutely dangerous fungicide), was found in tobacco smoke by its maker, Ciba-Geigy, and compared to tobacco was less carcinogenic in rats (!); however, the extremely toxic fungicide captafol is often mixed in with the mancozeb. The committee decided to measure Ridomil. Maleic hydrazide, a plant growth regulator, not acutely dangerous, was of interest to the group. [N.B. In other words, it appears that Coresta would focus on the least dangerous pesticides only!]

# 29 April 1982, meeting notes, "Meeting at the Federal Food Research Institute," RJR 511074295.

Discussion of draft manuscript by Drs. Fischer and Schmidt on Cesium-137 and Strontium-90 in tobacco. "The draft manuscript was revised."

3 May 1982, Colby memorandum for the record, "Re: Coumarin. Telephone conversation Adlkofer/Colby." RJR 504331530 - 1531.

Adlkofer has reassured Colby that the German Government will not withdraw any of the special permits to use coumarin in cigarettes. Colby says the government has to be reassured that the "lesions" in rats do not metastasize and therefore are not are not cancerous. [N.B. Most cigarette companies appear to have removed coumarin voluntarily by the mid-1980s.] Adlkofer knew that BAT had hired researchers on the subject but failed to inform the other companies or Verband regarding their experiments that may have shown carcinogenesis.

* 10 May 1982, Colby memo to S.B. Witt, "Re: German Cigarette Industry/ VdC research." RJR 502665408 - 5410.

Colby says "It is ‘imperative’ that Prof. Adlkofer’s position [as scientific director] be eliminated." He proposes a complex hierarchy of committees that appears to give the cigarette firms considerably more control over the research agenda.

# 17 May 1982, Stuhl memo to Pelz, "Telephone conversation with Dr. Kaussmann of Reemstma." RJR 504339755 - 9756.

Dr. Kaussmann stated that the general impression in the Scientific Commission is - and as far as he could tell amongst other member companies - that since about a year RJR is opposing most projects and is very rarely agreeing to projects.... It is my general impression that in the next VdC Board meeting RJR will come under attack.

* 21 May 1982, memo from Pelz to Adlkofer, "Grossarth-Maticek proposal," RJR 503246639.

The study "Psychological and medical factors as predictors of cancer and cardiovascular disease with particular reference to cigarette smoking," was approved and funded by VdC without

informing TFA. RJR insists a Dr. Bastiaans be included in the contract as "co-worker for Prof. Grossarth-Maticek." [N.B. J. Bastiaans of University of Leyden had been "discovered" by Frank Colby in 1974, RJR 504853314, as a researcher who "stresses psychosomatic aspects of disease, particularly heart disease. Have not found a paper in which he mentions tobacco." In other words, Bastiaans is to be Grossarth-Maticek’s watcher. In any case, Grossarth-Maticek did not disappoint: "[his] published data (semi-privately in a non-peer review serial)...lend[s] powerful support to the constitutional hypothesis of the alleged association between smoking and lung cancer." Colby, to S.B. Witt 21 May 1983, RJR 501626920 - 6921.]

* 24 May 1982, Peter Van Every (RJR in-house counsel) memo to R. Marcotullio, F. Colby, P. Schuler, U. Kuhlenschmidt (portion), "Contact with the Verband." RJR 500950316.

Van Every, new to his post succeeding S.B. Witt who became VP of RJR, lays down the rules on all procedures of reporting to and from Germany. Dembach [RJR counsel in Germany] to act as point man, monthly reports to go to scientists and lawyers, "Contact with the Verband. Except in extraordinary circumstances, only [RJR-Germany] GmbH should have direct contact with the Verband and the Forschungsrat. The reason for this is to strengthen the influence of the GmbH personnel.... In the past there has been confusion at the Verband and Forschungsrat as to who speaks for RJR."

# 24 May 1982, meeting notes, Fink to Osdene, VdC SCM, PM 2028524678 - 4681.

RJR rejected the use of hamsters in the proposed animal sidestream smoke exposure study.

* 1 June 1982, Pelz memo to Dembach, , "Telephone Note, VdC -- Professor Adlkofer..." RJR 502664593.

Prof. Adlkofer suggested a meeting with Pelz as "relations between the Verband and RJR have been recently hampered by deplorable fictions."

# 2 June 1982, meeting notes, Fink to Osdene, VdC SCM, PM 2028524676 - 4677.

Various proposals submitted and discussed.

* 4 June 1982, telex from Pelz to RJR counsel Peter Van Every, "VdC matters," RJR 503246015 - 6016, also RJR 504331572 - 1573..

Pelz outlines objections to Adlkofer’s dosimetry study proposal. The research has already been done by others, don’t repeat it you might find something.

Please note that these researchers – commonly regarded as avowed critics of smoking – could not find amounts of smoke constituents in the body fluids of passive smokers which could have any adverse health effects. Further studies could only weaken these already existing results from our opponents. Anti-smoking activists will always claim that any amounts of exposure on non-smokers to tobacco smoke is a certain type of assault and battery regardless of whether the concentration of tobacco smoke in the human environment is measurable by highly sensitive analytical instruments or not.

[N.B. Pelz cites three authors: Hugod, et al. "Exposure of passive smokers to tobacco smoke constituents," Int Arch Occup Environ Health 1978; 42: 21-9. Russell, et al, "Absorption by non-smokers of carbon monoxide from room air polluted by tobacco smoke," Lancet 1973; 1: 576-9. Russell, et al, "Blood and urinary nicotine in non-smokers," Lancet 1975; 1: 179-81. Despite the title, Hugod measured only the room air, not absorption by people. He does say that "passive smoke under usual conditions should [not] have a lasting adverse effect on otherwise healthy individuals," but limited this statement to hydrocyanic acid, total particulate matter, nicotine and carbon monoxide. But guess what? The study was supported by the Verband! under the rubric of the Forschungsgesellschaft Rauchen und Gesundheit. Russell in 1973 showed elevations of carbon monoxide in the blood of non-smokers to dangerous levels after a little over an hour in a very smoky room, as if they had actively smoked one cigarette. In 1975 Russell wrote: "It is concluded that, as a result of passive smoking, most urban non-smokers have measurable amounts of nicotine in their body fluids for most of their lives."]

* 8 June 1982, telex from Pelz to Van Every, "VdC epidemiologic study on public smoking," RJR 503246029 - 6030.

Counsels against joining in such a study (cost, complexity, need to coopeate with departments of health) but principally,

It is highly likely that the contemplated supplementary studies on risk groups will lead to adverse results because of the proneness of these risk groups towards negative statements on smoking and the lack of medical knowledge about the cause of the diseases (chronic bronchitis, asthma).

* 9 June 1982, memo Stuhl to Pelz, "ASFC smoking and health related research projects," RJR 503246497 - 6500.

Reviews the work of the Swiss Cigarette Manufacturers’ Association, mainly in the one-person show of Dr. Baettig. Stuhl accuses Adlkofer of trying to expand his empire by bringing Baettig support from VdC. The project list is unreadable.

* 14 June 1982, meeting notes, VdC TFA, Stuhl to Dembach, RJR 501545609 - 5615.

More discussions of the various projects being proposed or funded to begin or put off because of objections by one or more members. "Currently, RJR’s relations to the VdC are highly stressed. Adlkofer openly attacked RJR." One decision taken by Adlkofer was to have the VdC Board approve "certain research projects with political impact," and not to discuss these with the TFA. (The "Board" is the Forschungsrat, an institution similar to the Council for Tobacco Research.)

* 16 June 1982, Colby memo to Peter J. van Every, "Re: Research proposal to the...Verband on an epidemiological study on ‘passive smoking’ and lung cancer."

Colby strongly recommends that RJR veto the study on scientific, economic and political grounds, especially "if the study would be flawed and lead to results similar to the Hirayama study."

* 29 June 1982, memo, Pelz to RJR lawyers (USA mainly) and Colby, "Summary of VdC Smoking and Health Research Projects," RJR 500905494.

The German Cigarette Industry association (VdC) is sponsoring smoking and health related research through direct contracts with researchers, and indirectly through the Forschungsrat, and institution similar to the CTR [Council for Tobacco Research, USA].

# 30 June 1982, meeting notes, Fink to Osdene, VDC Scientific meeting, PM 2028524673 - 4675.

A "competent Federal authority" has proposed to do an epidemiological study of passive smoking (it will turn out to be Dr. Ueberla). RJR rejects a compensation study. Adlkofer argues for "scientific support for an industry policy which was the only possibility of maintaining the cigarette as a socially acceptable product even in the long term."

* 1 July 1982, Pelz report, 1 July 1982, RJR 500534225 - 28, "Meeting with Dr. Adlkofer... to discuss the Verband research philosophy, and other issues that have caused friction between the Verband and RJR on matters of smoking and health-related research."

Note below Adlkofer’s philosophy of a "safer cigarette."

Key Results. 1. The Verband research focuses on three areas of research: a) public smoking, b) risk factors and c) "a less harmful cigarette." While progress appears possible on a) and b), research on c) will continue to be a point of controversy and disagreement with the VdC. 2. Progress appears to be possible...on the composition and way of operation of the scientific committee, and on the way research projects are approved. 3) The research philosophy of Prof. Adlkofer will continue to be a point of controversy and disagreement, i.e. he being the one who defines the goals and direction of Verband research rather than the members of the VdC.... Prof. Adlkofer said that compared to Philip Morris, RJRTG seemed to be much more dependent on decisions made in the USA.... That smoking was not only correlated with various types of cancer but also constituted a real risk factor in regard to cancer, was to [Adlkofer] beyond doubt.... The US lawyers would do everything possible to maintain that friend-foe relationship between scientists and industry.... In this sense he considered FGC [Colby] more a lawyer than a scientist.... "[A] less assailable, less harmful...cigarette" was his main reason for being with the Verband. He said the disagreement on this subject with RJR was almost unbearable for him.... In his mind the open discussion about a "less harmful cigarette" between scientists and Industry has greatly helped Industry in Germany.... Talking about "the less harmful cigarette," he said that in his view there was a regulation of nicotine uptake in smokers. Therefore, it was of no use to him to go down in nicotine delivery below .4/.5 mg/cigarette, because otherwise the cigarettes would not be smoked. As a consequence, he said, one would have to lower the condensate delivery down to a ratio of 10 for T/N. This would most likely prolong the latency period for cancer by another 5- 10 years, and thus would make it a no-issue for the cigarette industry....[N.B. Emphasis added.] In his view there was not enough momentum behind such research in the individual companies.... He added that he was very happy with his role of instigating such research and creating unrest among Industry.

* 2 July 1982, Pelz telex to Van Every, "Epidemiology working group. Meeting with Prof. Adlkofer." RJR 503246039.

"From the discussion it became very clear that Prof. Adlkofer’s prime objective is to create unrest among industry in order to force industry into a direction of research that he calls less harmful or less assailable cigarette research."

* 14 July 1982, memo from Colby to Jay Giles, "Weekly Highlights," RJR 501626550.

There were additional activities on trying to prevent the Verband from carrying through the epidemiologic study on public smoking....

* 15 July 1982, telex Stuhl to Van every, "TFA meeting...re epi study / lecture by A.," RJR 503246244 - 6245.

A.[dlkofer] grossly summarized the research proposal by Prof. U.[eberla].... A. stated that the task force members had not understood this research proposal from the political point of view.... (A.) regarded this touchy project an entire political project which only the Board should discuss but not the TFA. A. stated that he will push this project through at the next Board meeting. [N.B. The politics may have had its payoff. For instance, Ueberla wrote a letter to the New England Journal of Medicine sharply criticizing the important study by Hecht showing uptake by non-smokers of tobacco-specific lung carcinogenic nitrosamines from passive exposure. Ueberla signed himself from the University of Munich. See New England Journal of Medicine 1993; 329:1543-6, and 1993; 330: 1016-7. As President of the Federal Health Office, Ueberla was in an influential position to determine policies on tobacco, both in Germany and within Europe. See 20 September 1983.]

[Adlkofer] said that VdC research is destined to deliver a frame-work for a less harmful cigarette which should be utilized by the R&D departments of the individual member companies to design presentable cigarettes. The problem is how to make such a product smokable. VdC research will prepare the basic concept for a product modification; nicotine must be present in a cigarette in sufficient amounts but without the other toxic substances.... [H]e knew that the less harmful cigarette is a hot issue....

* 15 July 1982, meeting notes, VdC TFA, Stuhl to Dembach, RJR 501545528 - 5533.

More review and re-review: Ueberla’s project will go to the VdC Board where the member companies can deal with the politics; a task force for the dosimetry study was formed; sidestream smoke analysis protocols were handed in from the different companies; Dr. Neurath introduced his research protocol for tobacco-specific nitrosamines; the N-PAH experiment at Richmond assumed more importance for PM; a plan to terminate Grimmer’s research on smoke carcinogens by having outside experts run it down (Hoffman, Preussmann, Sugimura); Dr. Obe wants to test his culture medium as a source of chromosomal abnormalities ion on-smokers; Adlkofer’s budget projection for VdC and the Forschungsrat research for 1982-85 is DM 4-5 million per year.

Cooperation with Prof. Wynder. Adlkofer recommended continuous cooperation and stressed Wynder’s pro-industry attitude vis-a-vis public smoking. Because of his expertise Wynder shall be paid $US 100,000 for another year as VdC consultant. Cooperation with Peter N. Lee (statistician). Adlkofer described P. Lee as a statistician of high expertise who had done a lot of work for VdC. Cooperation ought to be continued. Annual salary as VdC consultant will be DM 20,000 - in addition Adlkofer intends to give him _2000 - as fringe benefit and additional DM 50,000 - for doing the statistics of the Grossarth-Maticek project.

* 21 July 1982, part of a memorandum report, JK Wells (Brown and Williamson in-house counsel) to W.W. Wyatt (B&W management), "12. Ernst Bruckner from the Verband Reported on Several Projects." BW 00006-182090005.

The Verband is funding a study which will conclude that the motivation of anti-smokers is essentially a power drive.... The Verband has funded legal literature and a conference intended to produce material useful to those who would oppose the EC’s activities in non-economic fields, such as consumerism and health policy.... The Verband is attempting to obtain three government studies which were undertaken to show advertising influences people to start smoking but which were dropped when the results were going against the government’s position.... The Verband is funding work by an academic who will discuss political misuse of the language as illustrated by the equation of nicotine with hard drugs through the term "addiction".

* 22 July 1982, Colby memo to van Every, "Re: Smoking and health related activities of the Verband." RJR 500534218.

1. It has been learned that the Verband pays to Dr. Wynder the absolutely incredible sum of $100,000 annually as a consultant fee.... 2. More importantly, prof. Adlkofer has become more articulate recently regarding his "mission" of trying to bring the German Industry to adopt the "safer cigarette" philosophy... 3. Mr. von Specht is chief executive of BAT/Hamburg, Germany; he is also chairman of the Germany Industry Verband Executive Committee, composed of chief executives of the participating companies (Verstand).... There can be no question that they share the same view on the so-called "less harmful cigarette."

* 28 July 1982, memo from Stuhl to Pelz, "Proposed Obe project of the VdC," RJR 511074309.

Concerned that Obe will simply confirm his original findings of chromosomal abnormalities in smokers; even if he finds that the culture medium contributed, "he will most likely only ‘soften’ his allegations.... It cannot be excluded that Prof. Adlkofer will utilize results of this study to propagate further his allegedly ‘less harmful or less assailable cigarette.’"

* 18 August 1982, meeting notes VdC TFA, Stuhl to Dembach, RJR 501014963 - 4967.

Projects on Public Smoking Epidemiologic Study Adlkofer informed that the Scientific Advisory Board shall comprise: Prof. Lange (Head of Statistics Dept., Technical University, Munich) Prof. Viktor (Head of Statistics Dept., University of Heidelberg) Prof. Lehnert (Head of Institute for Industrial Medicine, Hamburg) Prof. Rose (Dept. Of Medical Statistics and Epidemiology, London School of Hygiene and Tropical Medicine) Prof. Wynder (American Health Foundation) Dr. Garfinkel (American Cancer Society) Dr. Sugimura (Director of the National Cancer Center Research Institute, Tokyo, Japan) [for Ueberla’s public smoking study].

Bids put out to research institutes for the animal sidestream smoke study, Obe’s project approved, dosimetry task force in place. Cadmium was declared carcinogenic by Germany’s MAK Commission. The flavor additive coumarin was found to damage the liver in animals, producing fibrosis of the small bile ducts and, said Adlkofer, "It could not be excluded that the majority of animals had cholangiofibroses, only, but a small number of animals had cholangiocarcinoma."

Nonetheless, President of the Federal Department of Health Ueberla said he would postpone a final decision on coumarin until all the data are in, and "would not consider cholangiofibroses a major obstacle for an official permit to use coumarin as additive for tobacco products." [N.B. This last statement reveals the pernicious effect on public health of the easy relationship between the Verband and the Professors, who sometimes become public officials.] Ueberla was ready to act, however, if BAT"s Barclay was to be sold in Germany (the Actron filter that tested one way and smoked another in relation to tar content).

# 19 August 1982, meeting notes, Fink to Osdene, VdC SCM, PM 2501325754 - 5759.

Ueberla declares that he has demonstrated that there is no proof of passive smoking causing lung cancer. SCM reviews several international studies on smoking and heart disease (including a European study by Geoffrey Rose showing heart disease rising while cigarette consumption was falling) and concludes that the correlation "cannot be very close."

* 31 August 1982, memo to file from R. Seligman, PM scientist, "Discussion with Alex Holtzman," PM 1003726061 - 6062.

Mr. Holtzman has no information concerning exposure of animals to sidestream smoke under the auspices of R.J. Reynolds. Through discussion with Dr. Osdene we were made aware of the fact that the VDC is not going ahead with its sidestream study.

# 2 September 1982, meeting notes, "TFA task force ‘Dosimetry,’" Stuhl to Dembach (inferred), RJR 501014626 - 4628.

Task Force decides to do a literature review and write a summary paper. BAT (for) and RJR (against) disagreed on measuring Polonium-210. RJR had scientific and "political" objections. RJR opposed a proposal to develop a theoretical model of sidestream smoke (which could lead to a safer cigarette) on grounds that product development was a company’s business, not the Verband’s.

* 9 September 1982, Stuhl memo (partial), RJR 501014828.

RJR opposes Verband activity for a "safe cigarette" because that is the business of the cigarette industry, not the Verband.

* 10 September 1982, meeting notes, VdC TFA, Stuhl to Dembach, RJR 501014852 - 4855.

Ueberla signed the contract for the epidemiologic passive smoking study. Various protocols moving along. Prof. Soeber argued for his theoretical model of sidestream smoke, one that he could sell to other industries. The animal nicotine aerosol inhalation study introduced (rats and/or hamsters), nitrosamines study protocol revised.

# 7 October 1982, meeting notes, Fink to Osdene, VdC SCM, PM 2025992063 - 2067.

For some reason the name of Prof. Ueberla is blacked out in this document.

* 11 October 1982, monthly progress report, Stuhl to Dembach, RJR 502664597 - 4600.

Much of the same reported above.

* 29 October 1982, report, K.G. Orloff (RJR scientist) to Colby, Witt and Nystrom, "Background information on toxicological and epidemiological aspects of cadmium," RJR 504219603 - 9607.

Criticizes the Fraunhofer Institute findings of lung cancer in rats exposed to high doses of aerosolized cadmium as not relevant to smokers who take in lower doses. Cites four industrial studies among factory workers exposed to cadmium: one showed increased incidence of lung cancer, three showed increased incidence of all cancers and all four showed increased incidences of prostate cancer. The latter finding is never referred to again in these tobacco industry documents.

* 29 October 1982, Colby and Nystrom memo to S.B. Witt, "Re: Cadmium." RJR 503642947.

German Government lists cadmium as a carcinogenic compound. They prepare a memo that says, "What little information is available on the cadmium study leads us to believe that the alleged results are highly suspect on their own merits." [N.B. The US Environmental Protection Agency predicts that a smoker inhaling 20 cigarettes a day for 20 years has an increased chance of lung cancer between one in 20,000 to one in 50,000. As much cadmium is find in sidestream as in mainstream smoke. Heavy smokers also risk kidney disease.]

* 29 October 1982, memo from A.A. Napier, PM EEC Region (Neuchatel) to Andrew Whist, Don Hoel and Tom Osdene (scientists and counsel), "Cadmium," PM 1000081214.

Concern expressed by the German government (MAK Commission) declaring cadmium carcinogenic. He asks for an urgent statement from PM (VdC is working on one for the German Industry).

The interlinking of the anti-smoking movements in various countries could result in the claims based on the [? ] research surfacing fairly quickly in other countries, and we would like to be prepared. Before the claimed relevance of this research to cigarettes spreads substantially, it may be helpful to address the question of the alleged levels of such constituents, and of the possibilities of reduction / elimination. [N.B. Ample cause for alarm. The Fraunhofer Institute of Germany claimed to show that rats exposed to high doses of cadmium chloride aerosol go lung cancer. The metal was already well know as an occupational carcinogen in battery factory, rubber industry and cadmium smelter workers, producing lung, prostate and other cancers.]

# 10 November 1982, Hoel telex to Andrew Napier, "Re: Cadmium." PM 1000081212.

Has consulted with Thomas Osdene "who has already taken some action in this area with Verband."

* 12 November 1982, memo from Colby to S.B. Witt, and P.J. Van Every, "Professor Dr. H Ruediger," RJR 503247068.

Salutes Professor Ruediger for his views on the genetic aspects of lung cancer, cited favorably by "Der Speigel."

Prof. Ruediger is the third of our only seven grantees who is cited in the German medica in a manner which is helpful for us on the ‘main issue’, i.e. the alleged health effect of smoking, and, most specifically, with reference to lung cancer. This is in striking contrast to the record of the Verband....

16 November 1982, minutes, Fink to Osdene, VdC Scientific meeting, PM 2001214840 - 4844.

Contract with Ueberla to study passive smoking is signed. Much discussion of the dosimetry study with respect to modeling behavior of particles, gases and twenty three classes of compounds in smoke: "The discussion showed that the cigarette industry is primarily interested in a pragmatic attempt to solve the passive smoke/dosimetry problem." A study of spermatogenesis in ex-smokers proposed.

*16 November 1982, meeting notes VdC TFA, Pelz to Dembach, RJR 503246382 - 6385.

Two scientists from BAT Southampton report on their nitrate studies, nitrous oxide being found in smoke, 80-100% retained in the lungs, 50-70% retention of carbon monoxide. "Prof. Adlkofer praised the work by BAT as an excellent example of cooperation within Industry."

Prof. Ueberla’s task force is on the ready (but here, confusingly, Prof. Rose is called Roe, as in Francis, the pathologist). The TFA discusses the implications of cadmium declared carcinogenic, prepare to analyze the matter, including inhalation studies, and examining how to remove cadmium from tobacco. Prof. Adlkofer has already discussed the matter with Prof. Hildebrand of the Federal Health Office.

# 17 November 1982, Colby memorandum for the record, "Re: telephone discussion with Wilfried Dembach on the forthcoming meeting of the Vorstand of the Verband." RJR 504331509.

Objects to funding of Dr. Astrup who found platelet aggregation [harbinger of blood clots] related to smoking. "It will under no circumstances mean an obligation to fund his poorly redacted research proposal on this topic without going through the regular approval or disapproval procedures."

* 18 November 1982, memo, Pelz to H.J. Weder (in-house RJR counsel), "Why should the tail not wag the dog?" RJR 501014587 - 4588.

Pelz says Adlkofer makes decisions before people have had a chance to think things through, creates complexities to make himself look smart in solving them, and cites influential opinion, "in order to support his point and prove his excellent connections." Pelz quotes Adlkofer on a point sore with US companies:

Should it turn out that cadmium indeed plays a role in the formation of lung cancers, the possibilities would exist to reduce the cadmium content in cigarette smoke, or perhaps eliminate Cadmium at all from cigarette smoke.... Cigarette industry should accept the conclusion from the Fraunhofer Study -- until they have been proven wrong -- as a real chance for product modification in the sense of a less harmful cigarette. It would be deplorable, if the enormous efforts would be in vain. My conclusion is that the tail indeed should not wag the dog."

# 9 December 1982, G. Scherer (Philip Morris) meeting report, "Minutes of meeting of TFA/TAC held at the Verband..." PM 1000131656 - 1658. [N.B. TAC is the British Tobacco Advisory Committee, formerly the Tobacco Research Council.]

Adlkofer noted "that the Board of Directors of the Verband expect the scientists of the industry to solve the passive smoking problem using scientific means." The two groups agreed.

* 13 December 1982, meeting notes, "Task force ‘dosimetry,’" Stuhl to Dembach, RJR 503246359 - 6360.

Task force agreed to a study in which human volunteers are exposed to realistic levels of sidestream smoke in an experimental room, analyzing blood, air, saliva for carbon monoxide and nicotine; a similar study to be done in the field under real life conditions. RJR opposed.

# 15 December 1982, Dembach memo to Colby, "TI position paper." RJR 504328534.

The US Tobacco Institute wrote a rebuttal to the 1982 Surgeon General Report, titled "Cigarette Smoking and Cancer: A Scientific Perspective." While the public relations committee of the Verband wanted to use the document, Prof. Adlkofer said it was anything but scientific.

* 16 December 1982, meeting notes, VdC TFA, Stuhl to Dembach, RJR 503246354 - 6358.

On Ueberla’s task force, Wynder demanded a case-control study, which Ueberla rejected. How to make objective measurements of uptake of smoke components, beyond subjective statements by the subjects, is up for discussion (saliva, skin, urine). Ueberla thinks "an animal experiment essential." The problem of cadmium absorbs them.

It was Adlkofer’s position in this discussion that the removal of cadmium from tobacco, quote, does not make a difference, cancer will remain since smoke contains substances such as nitrosamines, PAH’s etc. unquote.

Task force also absorbed with Polonium-210, still debating who should measure it. Baetigg’s study is reported out (no details) on whether smokers smoke for other than nicotine.

Pipe and cigar smokers are found to have high serum nicotine levels.

* 19 January 1983, Colby draft memorandum for the record, "Re; Telephone information...from Dr. Stuhl on the January 18, 1983 meeting of the scientists (TFA) of the Verband." RJR 500528918 - 8921.

Significant commitment made to cadmium research, examining lungs and kidneys of cadavers. Several other studies proposed that RJR had opposed (sidestream smoke, polonium platelet aggregation in smokers, nitrosamines, among others. Adlkofer wants to fund Prof. Lehnert’s work on cadmium, "necessary to maintain Prof. Lehnert’s ‘good will’, with reference to public smoking."

# 24 January 1983, minutes, Fink to Osdene, VdC Scientific meeting, PM 1000131364 - 1367.

Various projects in progress. Adlkofer takes the cadmium problem very seriously and wants it studied further, especially since (says Fink) "it is possible that there will be a limit on the cadmium content of cigarettes!!"

* 17 February 1983, Colby memo to S.B. Witt and P.J. Van Every, "RE: RJR Germany/ Verband/ Research." RJR 505743084 - 3086.

Recommends RJR not support the cadmium research.

* 12 March 1983, T. Finnegan draft letter (partial) to S.B. Witt, RJR 50574-5870.

Finnegan met with RJR scientist Bob DiMarco to review a White Paper prepared at Jacob, Medinger and Finnegan on smoking and health, intended for RJR-Germany. It was intended to show the Verband where RJR stood in contrast to Adlkofer who

believes that smoking is killing a couple of hundred thousand people a year and that his job is to cut that figure down to only 50,000 or so... [but] because of RJR Germany’s share of market it did not have enough clout to remedy this situation.... The paper was drawn largely from materials which we and the U.S. industry had used before in Congress and court.

# 18 March 1983, minutes, Fink to Osdene, VdC SCM, PM 1000131603 - 1607.

Passive smoking, dosimetry, cadmium, Polonium-210, N-PAH discussed. Pipe and cigar smokers’ nicotine levels comparable to cigarette smokers’. Prof. Valentin will check the results of the White-Froeb study with his own tests. The study on cadmium is prposed by Prof. Lehnert, to look at cadmium levels in post-mortem human organs.

Prof. Adlkofer explained that Prof. Lehnert is a member of the MAC [K] Commission. It is easier for Prof. Lehnert to provide help to the industry by presenting well-founded arguments in the discussion of the cadmium problem if he is able to refer to his own measurements. [N.B. Here is a classic instance of conflict-of-interest, and how Adlkofer cleverly coopts regulatory officials and consultants, who seem eager to be coopted, by awarding research grants. But also recall that the chair of the commission was Colby’s protege’ Prof. Henschler, see 10 April 1980. See also 20 September 1983 for how Lehnert paid back.]

* 21 March 1983, Colby memo to P. Van Every, "Re: meeting with Prof. Adlkofer on smoking/health research by the...Verband, March 18, 1983, in Chapel Hill, NC." RJR 501626812 - 6813.

Summary. I made it very clear to Prof. Adlkofer that whatever positions were in the past and would in the future be taken by our representatives in the Industry Scientists’ Committee (TFA) and other German Industry committees, were the results of Corporate consensus decisions arrived at after discussion between those concerned at RJR in Cologne and in Winston-Salem.

Adlkofer tried to fathom why Philip Morris and BAT and the German industry so often agreed with him, but not RJR. Colby replied RJR thought his projects were often neither necessary nor urgent, nor well conceived scientifically. Philip Morris gave its affiliates more leeway without checking back at headquarters, while RJR sought to maintain consistency in positions both in the US and outside.

* 23 March 1983, Colby memo to R. Di Marco, "Weekly Highlights." RJR 502665353.

Large numbers of documents were moved from Winston-Salem to the Jacob Medinger and Finnegan Law firm offices in New York to prevent discovery in law suits. This left Colby with no job. "Discussions were held in Washington with Mr. Jacob and Mr. Finnegan on FGC’s future career, and the consequences of the cut-off from the LRD data base."

* 13 April 1983, Colby memo to P. Van Every, "RE: Change of R&D Leadership at Philip Morris/Europe." RJR 501626818.

Herman Gaisch, Vice President of R&D at the laboratories in Neuchatel is being replaced. One speculation is his failure to obtain clearance from PM/New York on exceedingly concessionary postures on smoking and health related -- often ill-conceived -- projects by the... Verband.

* 13 April 1983, Colby memo to G.R. DiMarco, RJR 50101- 0370, "Re: Philip Morris -- American Health Foundation." [N.B. The late Ernst Wynder was founder and president of the American Health Foundation, a cancer-research institute based in New York. Wynder, of course, is renowned for his work showing cigarette condensate painted on mouse skin caused cancers, and his seminal 1950 publication linking smoking to lung cancer.]

I have now learned reliably that there are frequent contacts between Dr. Osdene, director of extramural research, etc., at PM/Richmond, and Dr. Hoffman of the American Health Foundation. Whether or not this involves anything beyond exchange of information, i.e., actual research on behalf of PM at the American Health Foundation, I do not know. In this connection I like to recall that earlier this year PM/Europe actively encouraged, and even insisted -- contrary to what in my judgment and in the judgment of others, are the best interests of the American Industry -- on farming out by the...Verband to the American Health Foundation of a project involving radioimmunoassay determination of nicotine and cotinine in the body fluids of active and "passive" smokers.

# 19 April 1983, minutes, Fink to Osdene, VdC SCM, PM 2028524644 - 4646.

Prof. Schmidt has published a paper in a German journal on passive smoking causing lung cancer in women. Other publications discussed.

# 20 April 1983, minutes, Fink to Osdene, VdC SCM, PM 1000131631 - 1633.

Prof. Adlkofer expressed the opinion that it will probably be impossible by means of epidemiology to detect any effect of passive smoking. Thus, carrying out animal experiments will be all the more important.

The blind restudy of umbilical veins by Prof. Mau, Staubesand and Hugod [N.B. See 4 June 1982.] shows the findings of the original findings by Asmussen to be

...artifacts. The criteria reported by Asmussen regarding the smoking behaviour have no discriminating characteristics. Umbilical cords are not a suitable object for investigation to establish any adverse vascular effects of smoking. [N.B. The peculiar language does not say what the restudy actually found.]

# 26 April 1983, minutes, Fink to Osdene, VdC SCM, PM 2001226683 - 6689.

Research proposals were considered. One that sought to examine the effects of nicotine on anti-cancer treatment was rejected: "Some members of the Research Council took the view that this application was obviously only an attempt to obtain funds."

# 29 April 1983, Herman Gaisch memo to S. Gunnarsson, "Minutes of the German Verband Meeting of April 19, 1983." PM 2501001001 - 1002.

The decision of the Vorstand is recorded to approve a proposal by Dr. Adlkofer covering two contracts.... One project deals with sidestream toxicology [N.B. See note below.] in animals and the other with sidestream dosimetry in humans. On both subjects Philip Morris has a well defined policy: we as a company do not engage in any industry research project or participate in such projects either by planning, contributing or any other way. If third parties do any such work, the "at arm’s length" approach is to be observed, i.e. we watch very closely what is going on, thus reserving our right to take any necessary step which might arise from the results of the investigations, from the way they are carried out or from the manner they are interpreted. As on several occasions before, Prof. Adlkofer has by-passed the ordinary consulting procedure of the Verband. This is why Dr. Fink was not given the possibility to warn you not to agree, in the name of Philip Morris, to the two proposals. I am convinced that Prof. Adlkofer deliberately chose this route in order to out-manoeuvre the scientists of the companies. I would like to ask you to be extremely careful in the future when approving anything in connection with smoking and health and make sure that you have either Dr. Fink’s or my advice on the particular issue. I have discussed today the whole matter with Dr. Osdene who was also unaware of Prof. Adlkofer’s initiative, although he had met with Prof. Adlkofer only a few days before the Vorstand meeting.... In view of the persons and institutions involved in these research contracts, it would be politically unwise for the Verband to go back on the Vorstand’s decision. However, we shall now try to minimize any possible embarrassment to the Industry by personal interventions with the appropriate people. It goes without saying that I wish this situation had not arisen.

(Hand-written note from M. Serrano to "Alcardo," circling the phrase "sidestream toxicology:" "This can be devastating for us.")

* 11 May 1983, Colby memo to R.Di Marco, "Re:Weekly Highlights." RJR 500908568 - 8569.

Notes that for use in court, his early memo that visual inspection of the color of lungs cannot distinguish smokers from nonsmokers, that sporting accidents entail a much higher social cost than smoking and alcohol combined, that the Verband was invited to work with the German Government on a report, "Cancer threat from smoking."

* 12 May 1983, Colby memo to S.B. Witt, "Dr. Ruediger and Dr. Grossarth-Maticek featured in the German edition of the international journal of the World Health Organization [World Health]." RJR 501626920.

Colby boasts that geneticist/lung cancer researcher Ruediger, "whom I ‘discovered,’" a grantee of RJR-GmbH and not the Verband, was able to get an entirely sympathetic interview from the WHO interviewer: "Interviewer - ‘And not every person gets lung cancer.’ Ruediger - ‘I agree.... Interviewer - ‘But [benzo(a)pyrene] is also found in soot or fried and broiled meat.’ Ruediger - ‘I agree....’"

* 19 May 1983, Colby memo, "Colby Correspondence Files." RJR 504437721.

[N.B. In the spring of 1983 it was decided to move sensitive documents to the offices of Jacob, Medinger and Finnegan, ostensibly to avoid discovery in the increasing number of lawsuits against the Industry. Virtually all of Colby’s files and literature retrieval system were to go. Colby’s own position with RJR was essentially eliminated, and he would go the New York to work at the Jacob, Medinger and Finnegan law firm, paid indirectly through RJR. See RJR 50266-5353, 23 March 1983, and item 1. Also, item 1, p. 116: 15-17, "Most recently, Dr. Koenig noted that Colby may be out of power at R.J. Reynolds. Koenig stated, ‘There may be a new philosophy being experimented with by the current R.J. Reynolds management which goes away from the ‘flat earth’ policy’."]

# 19 May 1983, minutes, Fink to Osdene, VdC SCM, PM 1000131256 - 1259.

Adlkofer reports on the New Orleans Lung Cancer Update Conference: Hirayama confirms his earlier study with another 200 cases of lung cancer. Ernst Wynder does not find a connection in his own case-control study. Richard Peto supports the "safer cigarette."

It was clearly expressed at the conference that smoking is the predominant etiological factor in the genesis of lung cancer. In the opinion of a large majority of the participants, air pollution, exposure at work and genetic predisposition play only a subordinate role or none at all.

At the ETS conference in Geneva, sponsored by Tobacco Institute, Charles Gilles of Scotland presented data showing increasing lung cancer based on dose of smoke in the following sequence: not exposed non-smokers/ passive smokers/ active smokers/ active and passive combined.

# 17 June 1983, minutes, Fink to Osdene, VdC SCM, PM 1000146512 - 6514.

Routine discussions of all projects in progress. Nicotine/cotinine in saliva do not correlate with passive exposure. Possible methodological problem.

# 12 July 1983, minutes, Fink to Osdene, VdC SCM, PM 2028524629 - 4633.

Debate between RJR and PM on animal exposure study: PM wants to use highest dose, RJR wants to use "realistic" dose. PM is gambling here on finding no effect, thus providing the best argument against ill-effects of passive smoke. Von Troschke proposes a literature study on the psychological benefits of smoking. Another TFA sponsored study reports on compensation and shows

that the majority of smokers show a relatively constant nicotine up-take over time. This can be regarded as an indication of nicotine regulation. A study of nicotine deprivation shows ...that nicotine smokers smoke their first cigarette more intensively with increasing withdrawal time. This only occurs in a much weaker form with non-nicotine smokers. [N.B. Whatever is meant by "non-nicotine" smokers – perhaps not-dependent -- these two studies point directly at the addicting qualities of nicotine and the self-medication of addicted smokers. Stuhl’s meeting notes in this period are absent. The apparent gap in RJR document dates here may be related to the May 1983 decision to remove RJR scientific papers, and Frank Colby himself, to the law firm of Jacob Medinger in New York. See *19 May 1983, RJR 504437721.]

* 14 July 1983, meeting notes, "Meeting at the German Federal Food Research Institute," Stuhl to Dembach, RJR 501011311.

The research concludes that humans take up more Strontium-90 and Cesium-137 from breathing air than from smoking a pack of cigarettes a day as transfer from tobacco to smoke is "minimal." The finding gave hope to the task force that "a similar approach could be conducted for rebutting allegations concerning cadmium in tobacco smoke."

* 2 August 1983, memo from Stuhl to Pelz, "VdC smoking and health related research projects – update," RJR 500905331.

Project topics listed are: nicotine, effects of whole smoke, public smoking, nitrosamines, nitrogen oxides, tobacco treatment, smoke analysis, tobacco additives, PAH metabolism, smoking behavior, market research..

In general, it can be said that all the shortcomings of VdC S & H related research...still exist... the number of research projects exceeds the capacity of the VdC scientific staff, the VdC projects are inadequately prepared and inadequately controlled, VdC research lacks conceptual thinking and perspective, the Verband very often jeopardizes the confidentiality which is needed to run the projects for industry.

# August 1983, monthly progress report, Stuhl to Dembach, RJR 501010111 - 0114.

Includes VdC TFA10 August meeting and 18 August VdC Board meeting. Research results are coming in: Ueberla’s epidemiologic study shows that only 10% of the German population considered themselves exposed to public smoking. A case-control study is deemed unlikely. Non-inhaling pipe and cigar smokers absorb as much nicotine as inhaling cigarette smokers. Dr. Grossarth-Maticek is reported in the press as indicating "that in smokers bad conscience can cause the outbreak of diseases which are alleged to be related to smoking, especially depression might reduce defense responses of the human immune system." Other studies still are pending: dosimetric, sidestream smoke analysis. Based on Benowitz’s finding that "low-tar low-nicotine" smokers still get as much nicotine, Adlkofer wants to do a nicotine metabolism study.

* 25 August 1983, telex from Fink (PM/Neuchatel) to Tom Osdene (chief scientist PM), "VdC Projects, 1000082097 - 2098 (second page unreadable).

Adlkofer proposed a nicotine metabolism study. The aim of the study is whether the serum cotinine concentration is the appropriate parameter for estimating nicotine uptake....BAT is fighting against this project (Barclay/Gori). He also informed me that if the VDC is not going to do this study the Forschungsrat will do it. Adlkofer also said that he has information according to which the "Project Ueberla" is planing a nicotine metabolism study in the context of the epidemiologic study. I think this is a case for our lawyers."

# 5 September 1983, minutes, Fink to Osdene, VdC SCM, PM 1000120576 - 0579.

Formation of NNN during the smoking process. Dr. Neurath’s final report was discussed. Based on the results, formation of tobacco specific nitrosamines during the smoking process cannot be excluded. TFA takes the view that the project should not be continued at the present time.

Adlkofer reports on the Fifth "Smoking and Health" World Conference (Winnipeg). The industry had to fight back against the anti-smoking forces, with science: to prove (contrary to the anti-smoking groups’ contentions) that passive smoking was not harmful, a safer cigarette was possible, and smoking has beneficial effects. "The industry must develop a conceptual scheme for defending itself better than hitherto, if it wanted to survive."

# September 1983, monthly progress report, includes VdC TFA meeting of 8 September 1983 and VdC Board meeting of 14 September 1983, Stuhl to Dembach, RJR 501010059 - 0060.

The public smoking epidemiologic study was voted to be prolonged by the Board. The animal passive smoking study was costed out by Dr. Brune, TFA asked for a lower cost. The dosimetry study is going through pretesting. Non-smokers may be studied for in vivo formation of nitrosoproline (a nitrosamine). Various national and international matters discussed (youth protection law to ban smoking under age 16; development of a less harmful cigarette; taxation to reduce smoking).

# 20 September 1983, Professor Adlkofer’s speech, "Passive smoking, presentation by the Verband der Cigaretenindustrie at the occasion on the NMA [National Manufacturer’s Association] in Washington DC." PM 2501021630 - 1639.

Classic apologia for smoking in public places. But the key phrases cover the cosy relationship between the Verband and the German Government of the time on the state of the debate about the ill-effects of passive smoking. In a discussion of Hirayama's research in Japan on passive smoking and lung cancer in the Munich Medical Weekly, "one of the most renowned German medical journals":

After giving both side(s) a chance to present its case the story ended with the authoritative conclusion of Prof. Lehnert, then head of the Germany Society for Occupational Medicine, who stated that no proof has been offered that passive smoking increases the risk of lung cancer. This, for the time being, did neutralize the impact of HIRAYAMA’s findings. However, industry is well aware of the fact that this state is in a very delicate balance and that only further co-operation with serious scientists can help to stabilize the situation. So industry by its research branch engaged itself in a research programme on passive smoking done by the highest health authority in Germany which is the Federal Health Office in Berlin. This co-operation, though rather new, is bearing already some fruit: In a recent statement on passive smoking in the Hessian Parliament the Hessian State Government cited from a letter of the Federal Health Office to the Federal Health Ministry. It said that inspite of the findings of HIRAYAMA and TRICHOPOULOS there is not sufficient evidence to support the assumption that passive smoking causes lung cancer in non-smokers.

Lehnert was receiving Verband research grants, while the "serious scientist" was, of course, Prof. Ueberla, who was head of the Federal Health Office and at the same time also being funded by the Verband to do epidemiological research on passive smoking, of a mediocre quality one should add.

# 6 October 1983, minutes, Fink to Osdene, VdC SCM, PM 1000036309 - 3611.

Adlkofer is using Reemstma’s ERGO labs for various nicotine studies. Fink finds this problematic.

* 31 October 1983, Charles Nystrom report, "Cause and prevention research, planned activities." RJR 501010032.

The question of nicotine as a co-carcinogen or precursor to carcinogens keeps emerging.

In view of the planned work at NCI, a study funded by the German Verband (and RJRTI) is of particular interest. The German Verband has contracted with Philip Morris to determine if nicotine is converted to nitrogen containing polyaromatic hydrocarbons during the smoking process....

# 11 November 1983, research report, unsigned, "Research Conference Rio de Janeiro, Brazil, August 1983," PM 2050987504 - 7527.

This important British American Tobacco conference has been fully described by Glantz, et al. In The Cigarette Papers, discussing nicotine research, the carcinogenicity of sidestream smoke, smoker compensation. An interesting, if cryptic, note on the Verband:

DUBIOUS PAST RESEARCHES The underlying principle was understood, but it was agreed that Dr. Blackman should talk further with Herr von Specht and Dr. Adlkofer to ascertain what positive action might be appropriate. Qualified third-party contact was thought necessary to make any real advance at this late stage.

# 1 December 1983, minutes, Fink to Osdene, VdC SCM, PM 2028524616 - 4618.

High doses of the additive coumarin causes weight loss and mortality in animals, also liver damage, with liver cancers and also cancers at other sites. The experimenters, Schmaehl and Brune wanted to follow up and replicate their own work. Fink comments: "[T]he experiment is unlikely to yield much of scientific interest."

# 13 January 1984, minutes, Fink to Osdene, VdC SCM, PM 1000121700 - 1703.

Concern over cadmium in tobacco and smoke:

[T]hat the industry should react appropriately to press accusations relating to environmental pollution by cadmium was generally accepted. Merely to present the facts was felt to be insufficient, they must also be "packaged" so as to be promotionally effective.

The Forschungsrat (Research Council) will work toward a low tar/ medium nicotine cigarette (Fink comments: "Does this somehow contain a suitable idea for a less harmful cigarette?"), research on the cause of heart disease and passive smoking.

# 28 February 1984, minutes, Fink to Osdene, VdC SCM, PM 2028524608 - 4611.

A nicotine metabolism study is proposed by Adlkofer, measuring uptake under real-life conditions.

* 29 February 1984, O. Stuhl report to W. Dembach, "Upcoming Adlkofer presentation in Lexington/USA on ‘Smoking and cardiovascular research in Germany’ February 27, 1984." RJR 501010458.

One of Adlkofer’s reports to be on nicotine levels in pipe and cigar smokers being about the same as in cigarette smokers, indicating inhalation [N.B. Or perhaps mouth-absorption?].

"Professor Adlkofer stressed that he had already obtained the approval of the Tobacco Institute (Mr. H. Kornegay)."

# 4 April 1984, memo Stuhl to Pelz, "Research proposal for a follow-up project by Prof. Staecker and Dr. Neuser," RJR 500916624.

The proposal is apparently to be funded directly by RJR for Dm 283,000, recommended by Stuhl. The study intends to show that certain breathing patterns might be predictable from a cluster of psychological factors (smoking men and smoking women differ, it is said in both breathing and psychology). Another premise is that certain psychological patterns might initiate the formation of chronic obstructive lung disease in smokers and non-smokers. "This project could perhaps elucidate whether or to what extent lung diseases are psychosomatic diseases."

* 10 April 1984, conference summary, Colby to Finnegan, " ‘International symposium on smoking and cardiovascular function’ organized by the Tobacco and Health Research Institute, Lexington, Kentucky...," RJR 500905026 - 5032.

The conference is held at the RJR-supported University of Kentucky tobacco research institute. Colby reports on VdC research by Schievelbein and Adlkofer on a dozen or more papers on the subject to appear in the May 1984 issue of the Klinische Wochenschrift, in English. One in particular is the research on nicotine in the blood of pipe and cigar smokers, being as high as cigarette smokers but who have less heart disease. [N.B. No study authored by Schievelbein or Adlkofer on this topic is found in the literature, or any related papers in the journal mentioned. A 1984 study by Schievelbein on carbon monoxide and nicotine in the blood of passive smokers – low levels – appeared in Preventive Medicine 1984; 13: 626-44.]

# 28 May 1984, research report (hand-written), unsigned, "Austria Tabak Forschung, Entwicklung, Intermediate report on the VdC (Verband Cigarettenindustrie) study of passive smoking." RJR 511365939 - 5950.

As the Industry kept requesting, a "realistic" study of the chemicals released into a closed room by two to four smokers, with measure of carbon monoxide in the blood of non-smokers staying in the room, each smoking session lasting about two hours. Chemicals measured included CO, nitrates, formaldehyde, acetaldehyde, acrolein, hydrocyanic acid, ammonia and nicotine. Elevations in all were found, and elevations in both smokers’ and non-smokers’ blood carbon monoxide were also found. [N.B. Study reminds us that smokers in a close-in space are the likeliest sufferers from passive smoking, their own and from fellow smokers.]

# 22 June 1984, minutes, Fink to Osdene, VdC SCM, PM 2001226007 - 6010.

TFA initiates a dioxin study in tobacco and smoke. Adlkofer reports on the well-orchestrated meeting of experts on "Medical Aspects of Passive Smoking," held in Vienna, April 9-12, 1984.

In the opinion of Prof. Adlkofer, the results of the meeting were optimal for the industry, and at present it appears that passive smoking is not a topic of acute interest in the FRG.... Presentations given in Vienna and round-table discussions will be published either in "Preventive Medicine" or in the WHO journal "World Health." [N.B. They were published in Preventive Medicine 1984;13:559, a publication of Wynder’s American Health Foundation, and cited in both the German and English versions of World Health (12 December 1984, p. 13, and May 1985, p 30, respectively). It created a stir because Prof. Valentin in his opening remarks said that WHO was a sponsor and welcomed the "high ranking representatives of the World Health Organization." The then coordinator of WHO’s program on smoking and Health, Robert Masironi, explained to William Kloepfer of the Tobacco Institute that the situation had been misrepresented -- no sponsorship, only a low-level representative as an observer – and was deeply embarrassing to Valentin who wrote to Masironi on 29 September 1986: "...the Vienna symposium on Medical Perspectives in Passive Smoking is being misused by the tobacco industry in Australia and other countries in an attempt to present the outcome as ample proof of their view claiming that passive smoking involves no risk to health.... Of course, I am prepared to disassociate myself from the cigarette industry should they stretch the truth and misuse the results of the conference for their own strategies." * PM 2025816621 - 6622. But Prof. Valentin was one of Colby’s prize recruits as a "most prominent German medical scientist and also has an outstanding international reputation." His other reputation with Colby for having been "the chief organizer of the only successful Watergate research activity of the Verband." with funds coming directly from RJR USA. * RJR 503247233 - 7257, and * RJR 504821257 - 1259.]

# 25 June 1984, minutes, Fink to Osdene, VdC SCM, PM 2023539434 - 9436.

13 studies totaling DM 2 million in grants approved by the Forschungsrat; most are on nicotine metabolism, two on respiratory diseases and smoking. The study on nicotine influence on chemotherapy was funded after all. A study by Dr. Gostomzyk, Adlkofer’s "secret envoy" to Hirayama is also funded (on sonograms of arteriosclerosis in the carotid artery of smokers and non-smokers).

* 25 July 1984, meeting notes, VdC TFA, Stuhl to Dembach, RJR 500906940 - 6942.

This document comes after a gap in the meeting note-records of ten months. The Ueberla team on public smoking is coming under pressure by its international scientific advisory board to do a case-control study, to validate subjective answers about exposure with urinary cotinine measurements, and to give more information about what had been achieved. The animal exposure study (Drs. Brune and Schmaehl) still being debated with respect to dosages of particulates. An interim report on the sidestream smoke analysis project is expected. The dosimetry study pilot experiments have begun. Dr. F.J.C. Roe has asked VdC to check cigarette smoke for bis chloromethyl ether, a proven carcinogen.

* 15 August 1984, meeting notes VdC TFA, Stuhl to Dembach, RJR 500906934 - 6936.

Epidemiology. Validation experiments. In exposure experiments with non-smokers who were exposed to unrealistically high concentrations of environmental tobacco smoke it was found that blood nicotine/cotinine...levels are inadequate parameters for determining exposure to "public smoking" because of big inter-individual variations.....[T]here is a discrepancy between data obtained from the same sample by gas chromatography (GC) and Radio-immuno-assay (RIA), which is inexplicable for the time being....Currently it is being checked for whether urinary nicotine/cotinine levels are more reliable indicators of "public smoking." [N.B. Russell and Feyerabend, Lancet, 25 January 1975, 179-81, had no trouble with any of their procedures, casual or high-intensity exposure. Adlkofer, Scherer and Hess wrote a letter to the New England Journal of Medicine, published 14 March 1985, to criticize Matsukura’s (et al.) lovely study (27 September 1984) showing cotinine levels rising in both smokers’ and non-smokers’ urine the greater their exposure to smoke; Adlkofer claimed to find one-eighth the amount and wondered if the radioimmunoassay was giving false results. Matsakura replied with side by side comparisons of gas chromatography and radioimmunoassay, showing 96-98% correlation in urine and blood.]

It is now reported that 25% of Ueberla’s test subjects report being exposed to smoking (earlier results had it at 10%). The animal exposure study, the sidestream smoke analysis project, the dosimetry study still under various stages of discussion or preparation. Nicotine metabolism in habitual smokers is to be studied, but RJR strictly opposes it. The hydroxyproline study by an M.D. thesis-student under Adlkofer’s supervision (see 16 July 1981) and presented by Adlkofer at the "indoor Air Pollution meeting in Denmark in January 1984, will be published in a Japanese scientific journal; "Prof. Kasuga has re-calculated Prof. Adlkofer’s data so that they now fit Kasuga’s hypothesis...."

# 7 September 1984, minutes, Fink to Osdene, VdC SCM, PM 2028524587 - 4589.

Francis Roe alerts Adlkofer to the active carcinogen bis-chloromethyl ether that may be in tobacco smoke, and should be investigated. "The TFA suggested that, as an intermediate measure, a literature study be carried out." [N.B. Nothing is mentioned on this topic again in the documents to hand.]

# 2 October 1984, minutes, Fink to Osdene, VdC SCM, PM 2025819218 - 9222.

Detailed results of questionnaire survey on passive exposure by recall (back to childhood) are reported and compared to the Hirayama indices of exposure. They appear similar.

* 18 October 1984, memo S. Gunnarsson to A.G. Buzz (PM counsel), "Barclay meeting," PM 2025440397 - 0398.

RJR, PM, Reemstma, and possibly MBAG (Martin Brinkmann AG) intend to sue BAT over the Barclay claims.

# 23 November 1984, minutes, Fink to Osdene, VdC SCM PM 2028524575 - 4578.

Severe criticism of the Grossarth-Maticek study, who was, however, supported by Adlkofer. Fink comments,

The prospective Heidelberg study contains serious shortcomings.... Deliberate manipulation of the data to fit the aim must be excluded. This is clear from the evaluation which has been carried out and from the documentation presented by Grossarth-Maticek.

# 26 November 1984, minutes, Fink to Osdene, VdC SCM, PM 2023539362 - 9363.

The follow up coumarin experiment also showed liver damage and cancer in the highest dose group of animals.

Prof. Adlkofer reported on the Infotab meeting in Washington at which there was discussion of the manner in which the industry could defend itself against the accusations relating to passive smoking. The manner of proceeding and the projects of the VDC were received with general approval.

# 17 January 1985, minutes, Fink to Osdene, VdC SCM, PM 202358318 - 8319.

Formaldehyde in cigarette smoke might be listed by the MAK commission. The paper on passive smoking epidemiology was submitted to the journal of International Archives of Occupational and Environmental Health. [N.B. Search of Medline 1985-1999 did not locate this article.]

# 21 February 1985, minutes, Fink to Osdene, VdC SCM, PM 2028524567 - 4572.

More Forschungsrat grants, ten, most on nicotine. Dioxin not found in tobacco or smoke.

The Obe study on chromosomal abnormalities in smokers is repeated in 100 smokers and 100 nonsmokers.

Based on the results, smokers show slightly higher rates of chromosome aberrations than non-smokers. The difference is small and only just significant. However, the difference is not as pronounced as originally found by Prof. Obe.

The orchestrated meeting on passive smoking in Vienna seems to have backfired: Prof. Remmer, member of the MAK-Commission, attacked the outcome of the "Vienna Meeting" and demonstrated that the danger comes from the gas phase (nitrous oxide, carbon monoxide, nitrosamines, aldehydes), not the particulate phase. "Prof. Remmer is to accelerate the inclusion of passive smoking in the MAK-list. In the opinion of Prof. Adlkofer, this will now hardly be avoidable." [N.B. In fact, Adlkofer later co-authored a paper coming to the same conclusion: Scherer G, et al., "Biomonitoring after controlled exposure to environmental tobacco smoke (ETS)," Experimental Pathology 1989; 37: 158-63.]

# 22 February 1985, minutes, Fink to Osdene, VdC SCM, PM 2023538822 - 8825.

Study on nicotine up-take regulation. Dr. Scherer proposes a nicotine nasal spray to measure uptake in ten subjects over 8 days. "RJR was against carrying out the study;.... the stress caused by nicotine and additional smoking is excessive...."

# 26 March 1985, minutes, Fink to Osdene, VdC SCM, PM 2028524559 - 4562.

More results of coumarin effects at high doses on rats. It is said smokers can absorb only 1/2,000th of the "no effect dose."

In rats, coumarin is without doubt toxic to the liver. Due to the different coumarin metabolism, it is to be expected that this will not apply to humans.... In the opinion of the experts, a risk/benefit analysis is likely to give a result favourable to the use of coumarin in tobacco.

* 26 April 1985, Stuhl memo to Dembach (partial), RJR 50419-7416.

Notes that in the end the British TAC did not offer any cooperation or funding to Verband for the passive smoking studies.

# 21 June 1985, G. Scherer meeting minutes, "Meeting of TAC/VdC on passive smoking research held at the Verband...Hamburg, on Friday, 29th March, 1985." PM 2001227421 - 7427.

Adlkofer recites history of passive smoking research, starting with the White Froeb study, Hirayama and Trichopoulos.. "Since then at least eight further studies had appeared most of them confirming the results by Hirayama and Trichopoulos." Verband still did not accept the link, however, between passive smoking and lung cancer or cancers of any other sites. On the other hand, good research by the industry was needed in collaboration with scientists all over the world. The TAC representatives agreed that the epidemiological study was most important. TAC’s approach, however, would be far more cautious than Verband’s activist approach..

* 11 July 1985, meeting notes, VdC TFA, Stuhl to Dembach, RJR 504222207 - 2210.

Continuation of Ueberla’s epidemiology project approved, to include subjective recall of exposure, validated by urine cotinine levels. Dr. Brune’s laboratory deemed insufficient for the animal passive smoke exposure study. An interim report on sidestream smoke analysis made (no details). A new study approved of smokers’ vs. non-smokers’ urines, measuring for hydroxylated PAH’s. Study planned to find the reason for different results from gas chromatographic and radioimmunoassay of cotinine in urine. Also a study approved to measure hydroxyproline in smokers’ and non-smokers’ urine. A grant given to Prof. Marz, factory doctor of the Hamburg Gas Company to investigate his claim that blue collar workers got more lung cancer than office workers independent of smoking. Request prepared for Federal Health Ministry to lift ban on coumarin as an additive.

* 16 July 1985, Charles Nystrom (RJR scientist) report to A.W. Hayes (RJR scientist), RJR 50422-1609 - 610 (part of larger review of scientific issues, especially ETS).

Severe attack on Verband scientific capacity:

Based on the overview provided by Stuhl, it is reasonable to conclude that much of the research currently funded by the Verband is of very poor quality and cannot be relied upin to be of much help to RJRT in either the short or long term. By contrast, many of the programs funded by RJRTI appear to have more technical merit and have the potential for yielding timely and useful results. As a point of fact, over the last half decade or so, the Verband has spent close to 10,000,000 DM (approximately $4,000,000 US) and for this expenditure, less than a half dozen studies have been published. In comparison, the research funded by RJRTI has expended less than 20% of this amount over the same period of time and has produced 15 publications.

# 30 July 1985, minutes, Fink to Osdene, VdC CM, PM 2028524551 - 4554.

New study on effect of alcohol on nitrosamine metabolism of smokers. Technical details of various exposure studies. Money is voted to study rare respiratory tract cancers in employees of Hamburg Gas Works.

* 2 August 1985, meeting notes, VdC TFA, Stuhl to Dembach, RJR 504808414 - 8417.

Follow-up to the public smoking study to include non-smokers’ urine tests. Dr. Brune’s laboratory to be upgraded for the animal passive smoke exposure study. A "butt length" study by BAT showed that in 1983, compared to 1979, butts were 0.3 mm shorter, perhaps due to higher prices, the tobacco tax increase being steep in 1982. A research proposal submitted to study cadmium uptake by tobacco plants.

# 2 September 1985, minutes, Fink to Osdene, VdC SCM, PM 2023539046 - 9050.

Verband may sue the MAK Commission over inclusion of passive smoking in Section IIIB rather than under "pyrolysis products". Specific technical details of animal passive exposure study are discussed; it is a complex business. Collection of 35,000 cigarette butts in Dusseldorf show shorter butts after the 1982 tax increase. A study on coumarin in England "gave results less favourable to the industry."

* 27 November 1985, meeting notes VdC TFA, Stuhl to Dembach, RJR 506230547 - 0550.

The subjective part of the passive smoking recall study (Ueberla) has to be repeated. Perhaps the subjects are too subjective, biased by their current health concerns. Brune’s animal exposure study to be further discussed after some pilot runs. Dosimetry study going on at Hannover. Sidestream smoke analysis "under real life conditions," showed "indoor levels of sidestream smoke constituents were lower than generally assumed. Dimethylnitrosamine could never be found." Adlkofer would like to take this project out into the field. Formaldehyde has been found in sidestream smoke; methods of measuring it were discussed. The MAK Commission kept public smoking on its MAK listing despite bitter complaints from Adlkofer and Ueberla.

* 13 January 1986, memo, Stuhl to Dembach, "RJR Extramural Research Program," RJR 515215886 - 5887.

A list of German scientists sponsored separately by RJR Germany: Blohmke, Jacob, Lock, Neubert, Ruediger, Staecker, Winneke, 275 thousand DM in 1985, 591 thousand DM in 1986. Specifics not given (see 26 May 1987).

# 21 January 1986, monthly report, "Meeting of TFA task force ‘animal exposure to sidestream smoke,’" Stuhl to Dembach (inferred), RJR 515215753.

Brune’s pilot studies indicate rats are not the appropriate species, nicotine levels in their blood and urine "were higher than expected so that results of a contemplated main experiment could never be interpreted conclusively," perhaps because the rats lick their coats. Group agreed that gas chromatography was the better method to measure cotinine.

* 22 January 1986, meeting notes VdC TFA, Stuhl to Dembach, RJR 506812035 - 2039.

In Ueberla’s study they found that statements of exposure did not match urine cotinine levels. Perhaps concern about health and anti-smoking propaganda colored the subjective responses. Brune will re-run his pilot experiments with hamsters, over RJR objections; the "main experiment" will never be done. MAK Commission will soon declare acetaldehyde a proven carcinogen, and a constituent of tobacco smoke. How to publish the sidestream smoke analyses is discussed, whether in Beitrage or to have an independent researcher re-do the study and publish separately. Do non-smokers take up nicotine from passive smoking through hair, saliva, skin? Cadmium levels in tobacco discussed.

* 27 January 1986, meeting notes, Stuhl to Dembach, VdC TFA, RJR 506812035 - 2039.

Poor correlation between subjective recall of passive smoke exposure and cotinine in the urine. RJR objects to a study of passive smoke with hamsters as a means of checking routes of uptake in rats. A similar study of route of uptake in human nonsmokers is proposed by Adlkofer. MAK Commission to include aldehyde as a carcinogen. A hospital study by Lee and Alderson shows no effect of passive smoking exposure on nonsmokers with any lung or cardiac disease. [N.B. This study was published: Lee PN, Chamberlain J, Alderson MR. "Relationship of passive smoking to risk of lung cancer and other smoking-associated diseases," British Journal of Cancer 1986, 1: 97-105.] On the other hand, a new study from Japan showed increased lung cancer in nonsmoking wives of smokers, replicating Hirayama’s work. [N.B. See Akiba S, Kato H, Blot WJ, "Passive smoking and lung cancer among Japanese women," Cancer Research 1986; 46: 4804-7. In this study a 50% increased risk of lung cancer was seen among nonsmoking women whose husbands smoked, in a dose-related relationship.]

# 30 January 1986, minutes, Fink to Osdene, VdC SCM, PM 2050805557 - 5559.

The Munich private laboratory GIS, which had been doing smoke analyses for the Ueberla study show their analytical methods to be flawed. They need supervision. MAK Commission decides that "an epidemiologically quantifiable risk is not necessary for the inclusion of passive smoking in the MAC[K] List. For this, even the occurrence of carcinogenic substances in the sidestream smoke is sufficient." [N.B. See 10 April 1986.]

* 24 February 1986, C.R. Green (RJR scientist) memo to Alan Rodgman, "Re: International ETS Working Committee." RJR 508192982.

Don Hoel (Shook, Hardy and Bacon) proposed formal cooperation be established between the Verband, the British Tobacco Action Council (TAC), the U.S. Tobacco Institute, Philip Morris and RJR on ETS. "It is expected that this will be the first of two or three meetings per year where the various committees will exchange scientific information and coordinate proposed studies."

# 26 March 1986, minutes, Fink to Osdene, VdC SCM, PM 2050805419 - 5423.

GIS worked with a non-representative random sample of 86 men and women non-smokers; half were not exposed to passive smoke, half were. "In a considerable percentage of non-exposed test subjects, urine cotinine values were found such as occur in passive smokers severely exposed to tobacco smoke." [N.B. This means either their lab analyses are totally off, or the "non- exposed" are far more exposed than appreciated.]

* 10 April 1986, meeting notes, Stuhl to Dembach, VdC TFA, RJR 515215708 - 5713.

Outline of the publication on sidestream smoke analyses as obtained in a smoke chamber, under defined environment, and under "real life conditions." The substances measured were: carbon monoxide, nitrogen oxide, nitrogen dioxide, formaldehyde, acetaldehyde, cresols, phenol, ammonia, hydrogen cyanide, nicotine, nitrosamine, particulate matter, benzo(a)pyrene, cadmium.

Study on mutagenicity of urine of five non-smokers exposed to passive smoke to be repeated at a higher carbon monoxide level as earlier study showed a small but statistically insignificant increase. Results of nitrosamine tests on same group by Dr. Klus were "incoherent and contradictory." TFA alerted to new methods of measuring binding of carcinogenic chemicals to DNA ("adducts").

# 30 April 1986, minutes, Fink to Osdene, VdC SCM, PM 2001228188 - 8191.

Working Group "Cancer Risk Due to Smoking.... Prof. Remmer expressed the view that passive smoking is a proven cause of cancer. Prof. Henschler referred in his assessment to the fact that no threshold values exist for carcinogenic substances such as occur in tobacco smoke. Even though their magnitude cannot be determined at present, a cancer risk had to be assumed. Prof. Franke requested the working group to prepare an expert opinion on the matter of passive smoking. [N.B. The persons named are not part of the Verband group. Henschler was Chair of the MAK Commission.]]

* 21 May 1986, meeting notes, VdC TFA, Stuhl to Dembach (inferred), RJR 515215739 - 5742.

Continuation of various projects. Dr. Neurath reports a new main metabolite of nicotine, 3-hydroxy-cotinine; TFA will approve a new study of the same in urine samples. Dr. Obe’s chromosomal abnormality study is up for refunding to measure the effect of the cell culture medium (same request was discussed several times in 1982).

# 5 June 1986, minutes, Fink to Osdene, VdC SCM, PM 2028524526 - 4528.

A study – not available from these documents -- of mutagenicity in urine of persons or animals exposed to smoke was done at a relatively high room air concentration of carbon monoxide of 20 parts per million. The results will be confirmed at a more realistic upper limit of 10 ppm (suggesting positive findings at the higher dose).

* 9 June 1986, monthly progress report, Stuhl to Dembach, covering TFA meetings of 13 and 29 May, and VdC Board meeting of 28 May. RJR 515215698 - 5701.

Hamsters take up somewhat less nicotine than rats do, but whole-body exposure causes more uptake than simple nasal exposure. An MD thesis on tobacco and Parkinson’s disease approved by the Board, TFA not informed before hand. Dr. Lock reports that there might be a familial predisposition to lung cancer, and higher rates in urban areas due to age difference.

# 17 July 1986, minutes, Fink to Osdene, VdC SCM, PM 2001228078 - 8080.

More suggestive findings by Prof.. Obe on chromosomal aberrations in white blood cells of smokers.

# 23 July 1986, minutes, Fink to Osdene, VdC SCM, PM 2001228107 - 8108.

As above.

# August 1986, meeting notes, Stuhl to Dembach (inferred), "Meeting of the VdC working group ‘Tobacco and Radioactivity," RJR 506230439 - 0440.

Details of the planned measurement of radioactivity (total and cesium-137) in the top 10 German cigarette brands, and leaf samples from member companies.

# 13 August 1986, monthly meeting notes, VdC TFA, probably Stuhl, RJR 506855427 - missing.

Dr. Neurath found 3-hydroxy cotinine in all smokers’ urines tested

# 18 August 1986, "Minutes of the VDC-meeting on radioactivity," 31 [sic] July 1986, author probably Walter Fink, PM/Neuchatel, PM 2001295528 - 5531.

Necessary to measure radioactivity in the soils from countries that provide the tobacco, as well as in the cigarette brands themselves ("...such a comparison represents the greatest journalistic stimulus for the press."). Technical details and company assignments to the tasks. VdC to act as a neutral in the matter. Cesium-137 mainly mentioned.

# 4 November 1986, minutes, Fink to Osdene, VdC SCM, PM 2028524518 - 4520.

Whole body uptake of nicotine greater than nose-only uptake in hamsters.

# 18 November 1986, minutes, Fink to Osdene, VdC SCM, PM 2028524516A - 4517.

MAK list for 1987 includes cadmium, 2-propanol, vinyl acetate and NO/NO2, which are relevant to the tobacco industry. The Wissenschaftspolitische Ausschuss (WPA -- Science Policy Committee) will succeed the SCM (TFA) as the science and industrial research policy committee.

# 23 December 1986, letter, Hans Barkemeyer to Gill Esterle (Brown & Williamson), "‘Passive smoking’, activity of the ‘VERBAND’", BW 656031048 - 1051.

"The problem is treated on a broad basis in order to be prepared for all accusations."

Describes four areas: epidemiology, animal experiments with sidestream smoke, dosimetry of ETS deposition in men, analysis of ETS compounds under various conditions.

* 6 January 1987, memo from Stuhl to Dembach, "RJR extramural research projects -- update," RJR 515215638 (one page only, attachments not available).

Fields listed are psychomedical, psychophysiological, biochemistry, anatomy, epidemiology (12 in all). "The thrust of nine projects is to get insight into whether or to what extent genetic factors/predisposition are the cause for developing certain behavioral traits and/or diseases (e.g. lung cancer)."

# 19 January 1987, minutes, Fink to Osdene, VdC WPA, PM 2050804957 - 4959.

Dr. Schievelbein’s Munich laboratory (GIS) will become Prof. Adlkofer’s laboratory as the former retires. The conditions for Adlkofer included the stipulation that "the secrecy of the results must be warranted."

# 20 January 1987, memo, from Fink to Osdene, "VDC," PM 2050804956.

Succession and conversion of TFA to WPA.

* 18 February 1987, Charles Green to Rodgman, etc., " VdC animal experiment on passive smoking." RJR 506317566.

Green asks advice on whether RJR-US should participate in the Verband study.

* 18 February 1987, monthly progress report, Stuhl to Dembach, (cover letter transmittal Dembach to Van Every). RJR 506230386 - 0388

Brune’s animal exposure study continuing at an exposure level of 4 nanograms per cubic meter of total particulate matter, for 90 days. The "TFA" is now referred to as the "WPA," the Science Policy Commission.

# 9 March 1987, minutes, Fink to Osdene, VdC WPA, PM 202852492 - 2494.

The cigarette company Martin Brinkmann has been studying thioether and mutagenic substances in the urine. Members protest: "A point of particular importance is to find alternatives to avoid the comparison between active and passive smoking." The old TFA becomes the TWA (Technisch-Wissenschaftlicher Ausschuss, TWA, the "Technico-Scientific Committee). [N.B. A search of the Philip Morris document web site using this German name reveals 72 documents mostly duplicates, from 1991-1992, and in German. They seem to deal with mainly technical discussion on pesticides , CORESTA measurements and the like.] "Prof. Adlkofer will contact Prof. Atteslander on the basis of the points discussed at the WPA. The WPA could not support further co-operation with Prof. Atteslander." [N.B. Peter Atteslander might have become an embarrassment. He was a professor of sociology at Augsburg University, later moved to Switzerland where he set up AGEF, Arbeitsgruppe Gesundheitsforschung, Health Research Working Group which he used to write strongly pro-industry documents. He tried hard, and succeeded to become a PM consultant, offering to influence WHO. See *PM 2501011220, # PM 2028531400, and *PM 2048224106, among others.]

* 12 March 1987, memo, Stuhl to J.D. Phillips, "Comments to Dr. A.W. Hayes’ critique of the forthcoming VdC experiment ‘Animals exposure to sidestream smoke,’" RJR 506317554 - 7560.

A. Wallace Hayes was an RJR toxicologist in Winston-Salem who had conducted similar exposure experiments. In this memo, several persons have written comments in the margins, generally unfavorable to Stuhl’s comments. The main issue was how to conduct nicotine uptake studies when all of the animal seemed to be exposed. Stuhl argues that whole-body exposure causes less stress than nasal-only. Also at debate was the levels of exposure to total particulate matter and the reliability of its measurement, carbon monoxide levels, flow rates, etc. An altogether daunting problem of design.

# 13 March 1987, monthly progress report, Stuhl to Dembach, (cover memo transmittal Dembach to Van Every). RJR 506230389 - 0393.

Brune’s study approved, task forces set up to design experiments. Nicotine uptake studies on humans by various body routes approved. German brands to be monitored for radioactivity, including review of post-Chernobyl data on food. Discussions on various topics inlcuding pesticides, ozone depletion, etc.

# 26 May 1987, monthly progress report Stuhl to Dembach, (with cover letter transmittal Dembach to Van Every). RJR 506230336 - 0340.

WPA decided on a study of urine in humans exposed to ETS, looking for mutagenicity and thioethers (which bind to supposed mutagens by detoxification in the body). Adlkofer wishes to look at road pavement workers who may be exposed to more phenanthrenes, excreting polycyclic phenanthrenes in greater quantities than non-smokers exposed to ETS. Stuhl reports on a conference in which Forschungsrat sponsored research was presented. "...Forschungsrat research is of a very high scientific caliber. Many presentations refuted previous claims concerning allegedly harmful effects of nicotine, or even showed positive effects of nicotine."

RJR’s extramural research is presented: Dr. Baettig of Switzerland on "smoking and eating"; Dr. Winneke on subjective and objective reactions of humans to ETS, and odors that annoy; Dr. Lock on cancer mortality incidence rates [sic] being constant between 1961 and 1981. Also, Verband to measure benzo(a)pyrene in German tobacco products. Discussion of the ongoing legal battle against BAT and its Barclay cigarette. Geneva Court of Justice ruled against BAT for committing an act of unfair competition by marketing Barclay as a 1 mg condensate / 0.2 mg nicotine brand.

# 15 June 1987, minutes, Fink to Osdene, VdC WPA, PM 205080513 - 0514.

The study of thioether excretion in passive smokers’ urine is approved provided it is not initiated by VdC, done in Adlkofer’s lab, and results available only to Adlkofer and Scherer of VdC, with summarized information only to the WPA.

# 22 June 1987, memo from A. Wallace Hayes to J.D. Phillips (both RJR), "Re: German reseach program/ Verband interaction." RJR 506230341 - 0343.

Despite the departure of Frank Colby from the scene, RJR staff still having trouble keeping Verband research in line. This memo suggests Verband stick to research on additives, and urges separation of research funded through Verband ("nonproprietary") and that funded directly by RJRT Germany ("proprietary"). As did Colby, Hayes expresses dissatisfaction with the research to date: "We need to develop a new cadre of grantees who can conduct experiments that will stand the scrutiny of modern peer review....to enlist the best scientists that we can to undertake those projects that will be beneficial to us...."

# July, monthly progress report, May/June, Stuhl to Dembach (inferred), RJR 506230328 - 0330.

The Governmental Working Group on Smoking and Cancer plans to study nitrosamine and polycyclics in smoke. A Dr. Winneke will study "subjective and objective reactions of humans during exposure to ETS, noise and industrial odors in order to find out whether or to what extent the probands shown annoyance reactions." A Dutch physician Dr. P. Holst found that lung cancer was especially prevalent in families that owned caged birds. [N.B. See 26 October 1987.]

# 31 July 1987, minutes, Fink to Osdene, VdC WPA, PM 2050804884 - 4886.

A "Cancer Risk by Smoking" working group has been meeting from time to time. Adlkofer reports on Swedish snuff, supposedly safer than smoking. A study is proposed to show that cotinine is not a good marker of passive absorption of smoke, and therefore passive uptake is different from active smoking. "The conclusion from the presumed results would be...."

* 1 October 1987, report A.W. Hayes (RJR toxicologist and expert on animal exposure studies) to R Dimarco (RJR counsel), "Environmental tobacco smoke" (portion of 14-page overall report on scientific matters), RJR 506464697 - 4698.

Analytical measurements for the vdc ETS inhalation experiment. As reported earlier, Mr. Dave Reavner and Drs. Oskar Stuhl and Charles Green visited Dr. Brune’s laboratory in Hamburg, West Germany to collect a series of samples for measurement of RSP, nicotine, and carbonyls in the exposure and sham animal inhalation chambers for the VdC ETS experiments. Analyses of these samples is now complete and the results have been sent to Dr. Stuhl for presentation to the Analytical Advisory Committee.... [V]irtually all of the particulate matter in the exposure chamber is in the respirable range. RSP values range from 3.9 to 5.3 mg/m³.... These analyses also demonstrate that more than 90% of the nicotine is in the vapor portion of the aerosol.... Carbonyl results... 2-3 times more acetaldehyde than formaldehyde....

The values given are as follows (in mg/m³) : Formaldehyde 0.293 - 0.597, Acetaldehyde

0.828-1.306, acrolein 0.267 - 0.542, acetone 0.733 - 1.076, proprionaldehyde 0.227 - 0.351. [N.B.The value for formaldehyde is well over the "minimal risk level" (MRL), an estimate of the greatest amount of human exposure without appreciable risk of cancer. The Agency for Toxic Substances and Disease Registry (ASTDR) in itsToxicological Profile for Formaldehyde: Draft for Public Comment, February 17, 1998, gives for acute exposure (< 15 days), 0.062 mg/m³, for intermediate exposure (15 to 364 days), 0.012 mg/m³, and for chronic exposure (>364 days) 0.0037 mg/m³. These results clearly indicate the problem of ETS, and validate the findings in peer-review journals on humans exposed to passive smoking.]

* 26 October 1987, monthly progress report, Stuhl to Van Every, covering VdC Board meeting 26 May and 25 June, and WPA meeting 26 June, RJR 506230328 - 0330.

In the continuing study of humans exposed to ETS, Adlkofer predicts that, "as interim results indicate – one outcome of the project will be that nicotine and cotinine levels in body fluids of ETS exposed humans are not valid markers for ETS exposure." [N.B. Ignoring the impressive literature to the contrary...] The thioether project approved. VdC will submit a research proposal to the Federal Health Ministry focusing on tobacco nitrate levels on nitrosamines, polycyclics, and "biological activity" of smoke. [N.B. This would not be a new finding at all; see Schmeltz and Hoffman, Chemical Reviews 1977; 77: 295-311.]

RJR extramural research: now also mentioned is Neubert’s research on BaP metabolism in animals. Mention is also made of a Dutch physician who found lung cancer especially prevalent among families with cage birds (the fat excretions in bird feather lubricant blamed). [N.B. Wynder did a proper case control study a few years later and found no connection. See Morabia A, Stellman S, Lumey LH, Wynder EL, "Parakeets, canaries, finches, parrots and lung cancer: no association." British Journal of Cancer 1998; 77: 501-4. A ten-fold risk was found among non-bird keeping smokers.]

# 28 October 1987, memo, Fink to Osdene, "VDC - Nitrate vs. nitrosamines/PAH/Biological activity," PM 2050804925 - 4926.

The working group on "Cancer risk due to smoking," has discussed these carcinogens because the Department responsible for tobacco regulations in the Federal Ministry of Youth, Family, Women and Health (Dr. Hundsdorfer) has asked if the industry is ready to tackle the problem. WPA decided that a study to correlate filler nitrate content and biological activityn was necessary. Fink notes that PM brands have high nitrate in the filler.

# 11 November 1987, memo, Stuhl to Dembach, "The effects of nicotine - recent research results," RJR 509019130.

Stuhl reports on two symposia on nicotine, one in Titisee, Germany, one in Brisbane Australia.

In general one can see that the attitude in the scientific community towards nicotine is profoundly changing. Part of this change was contributed by the German Forschungsrat, the independent German Research Institution, which is funded by Industry. The idea that eminent German scientists, when doing independent research on nicotine, will explore new avenues, has turned out to be very promising as one can see from the results....

The results? Seven papers are mentioned with topics such as: cardiovascular effects of nicotine, effects of nicotine on eicosanoids and blood platelets, effects of nicotine on tracheal mucus secretion, enterologic effect of nicotine, nicotine receptors in the brain/cerebral action of nicotine, effects of nicotine on behavior and performance, pharmacologic/toxicologic effects of nicotine.

# 1 December 1987, minutes, Fink to Osdene, VdC WPA, PM 2050805283 - 5285.

Dr. Klus reported on the ‘passive smoking hearing’ planned by the Austrian Minister of Health. The hearing is to be carried out in May 1988 with an international scientific team. Austria Tobacco is able to influence the scientific and organizational arrangements.

* 31 December 1987, John Rupp (Covington & Burling) letter to Gunter Wills (Philip Morris- Germany), PM 2501474303 - 04.

In recruiting consultants who would be friendly to the industry in Europe,

We had identified an unusually promising group of scientists in West Germany.... We plan to target West Germany for special efforts during the first three months of 1988. I also am prompted to do that by my sense that at least some of the VdC directors may want to reconsider the approach to the ETS issue...if we are not able to make substantial progress in a fairly short period of time.

* 25 January 1988, John Rupp letter to Bradley Brooke (Philip Morris EEC Region), PM 2501474296 - 301.

West German Witness Project.... I have not yet had an opportunity to respond to Gunter’s (Wills) telex of January 18, which came -- I must admit -- as something of a surprise. Our efforts in West Germany have been characterized by a number of fits and starts...we put our efforts on hold so that the VdC could consider the matter; we then geared up again, only to be told now that the VdC has decided neither whom they want to recruit as ETS consultants in West Germany or whether the project should be financed through VdC.

* 25 January 1988, meeting notes VdC working group "Nitrate in tobacco leaf," Stuhl to Dembach, RJR 506230458 - 0459.

Study outlined to look at mainstream smoke for various typical constituents (condensate, carbon monoxide, nitrogen oxides, acetaldehyde, phenol, nitrosamine, polycyclics, nicotine, ammonia, formaldehyde, acrolein, hydrogen cyanide, heavy metals, harmane/norharmane, radicals/thiol activity, all as a function of leaf nitrate in cigarettes.

# 16 February 1988, minutes, Fink to Osdene, VdC WPA, PM 2050804782 - 4784.

Coumarin: "A retraction of our efforts...to make coumarin acceptable in cigarette production would be understood to be a weakening of our position, with the risk of inclusion of further substances [as permitted under Tobacco Regulations] being blocked at a later date."

* 20 February 1988, memo from David Remes to Helmut Gaisch (PM/Europe), "The PM EEC / EEMA ETS Project," PM 2501474271 - 4277.

Remes describes a total strategy, the objective,

is to prevent the imposition of smoking restrictions in the EEC/EEMA [N.B. European Economic Community / Europe, Eastern Mediterranean, Africa.] regions based on the asserted health hazards of ETS to non-smokers. To realize this objective, three audiences must be persuaded that the health claims by anti-smoking forces concerning ETS are groundless. These three audiences are the scientific community, regulatory authorities, and the general public.... The argument against smoking restrictions based on the existence of "controversy" on the ETS health issue also is unlikely to prove persuasive because it is so reminiscent of the industry’s argument on the primary health issue, which virtually no-one outside the industry accepts. Thus, the industry will have to establish affirmatively that ETS presents no significant health risk to non-smokers.

Various consultants will be recruited (including Francis Roe), a total corporate strategy coordinated with headquarters and the law firm of Shook, Hardy & Bacon. "VdC appears to have matters well in hand and has not been eager to accept outside help." Dr. Adlkofer will coordinate with lawyer Don Hoel of SH&B on a general hearing before the Austrian Health Minister.

# 10 March 1988, meeting notes, "Meeting of the VdC working Group ‘Radioactivity and Tobacco,’" Stuhl to Dembach (inferred), RJR 506831242.

Discussion on how to go about measuring radioactivity in imported tobacco from non-EEC countries.

# 17 March 1988, minutes, Fink to Osdene, VdC WPA, PM 2050804819 - 4821.

Strontium 90 to be measured in the top 12 brands

* 26 April 1988, meeting notes, "Meting of the VdC Working Group ‘Nitrate in Tobacco Leaf,’" Stuhl to Dembach, RJR 506846222 - 6223.

Finalizing the details, with BAT to supply the experimental cigarettes. Division of analytic tasks among the member companies. RJR attacked for refusing to take part.

# 29 April 1988, minutes, Fink to Osdene, VdC WPA, PM 205080452 - 4854.

Adlkofer seeking increased funding for his Munich laboratory. On coumarin, WPA decided to take a hands-off approach to the upcoming Government decision. It is clearly seen as carcinogenic.

* 6 May 1988, report, L.A. Eubanks, "Tobacco Industry Companies, Committees and Organizations," BW (Brown & Williamson) 681510934 - 0938 (UCSF 22148 - 22152).

Author lists the following US and European-based organizations:: Bill Hecht & Associates (identifies potential recipients of Tobacco Institute political donations); Council for Tobacco Research, ETS Advisory Committee, Industry Research Review Group, National Association of Tobacco Distributors, National Candy Wholesalers Association, National Tobacco Council (a partner to:) Tobacco Institute, INFOTAB/ICOSI, University of Kentucky Tobacco and Health Research Institute, Tobacco Advisory Committee (UK), and the Verband der Cigarettenindustrie.

"The VdC is the German equivalent of CTR. It had many government dealings and was supported by the German cigarette industry. The German factions of RJR and PM are members of the VdC. (Is BAT a member?)" [N.B. This off-hand question indicates that Verband was not high on BAT/B&W agenda, unlike RJR and PM – and, of course, the German-language companies.]

* 13 May 1988, memo from M. Garnick to M.H. Crohn, A. Holtzman, E . Pepples, A. Stevens, "Memorandum from W. Fink of the VDC to Osdene, dated September 16, 1981 (1000121264)." [N.B. Cross reference to 16 September 1981, PM 1000121264 - 1267.]

This report of a memo is a lawyer’s briefing of other counsel on the legal implications of a previous memorandum by a PM employee discussing Adlkofer’s desire to study nicotine absorption in pipe and cigar smokers.

With respect to nicotine projects, Fink explains that Dr. Adlkofer suggested the sponsoring of a doctorate thesis on the topic of the absorption of nicotine by pipe and cigar smokers. According to Fink, however, "PM rejects the suggestion that the project be carried as a doctorate thesis because the results are not controllable by the industry." Under the court’s post-1966 ruling, this document should be excluded in its entirety, since it deals exclusively with industry research post-1966 and would not be relevant to the suppression of third party claims. CROSS POINT Harris cannot know what Fink meant by the use of the word "controllable" in this document. This document clearly indicates that the industry was sincerely interested in conducting the research. Accordingly, the best reading of this passage is that it concerns the industry’s interest in having control over the research in order to ensure that (1) the proper research was conducted and (2) the research constituted good science. If the research was instead conducted by a doctorate student, the research might be flawed or sidetracked in an unanticipated direction of less relevance to the industry.

# 6 June 1988, meeting notes, "Meeting of the VdC Working Group ‘Nitrate in Tobacco Leaf,’" Stuhl to Dembach (inferred), RJR 506891592 - 1594.

Details of analyses to be done on cigarettes with varying nitrate contents of the tobacco leaf. In addition to biological testing of condensate, there will also be cytotoxicity testing and genotoxicity testing, and a test of respiratory irritation to be done by RJR).

# 14 July 1988, memo, from Fink to Robert Pages (PM counsel), "VDC," PM 2050804934.

"Attached is a German patent application by Adlkofer.... After reading the abstract I would like to know how far this person has to go to be removed from his present position. He directly supports the last report of the surgeon general."

* 15 July 1988, Don Hoel (Shook, Hardy & Bacon) meeting report memorandum,

RJR 50681-2115 - 28, PM 2021548236 - 37, "Joint meeting on ETS - London, England," June 17, 1988."

An extraordinary summit of all the major tobacco companies and their law firms. Represented were (in the order listed by Hoel): Verband, BAT, Reemstma, Philip Morris/Europe, Philip Morris/USA, Philip Morris International, Tobacco Advisory Council, Gallaher, Rothman’s, Rothman’s International Services, Shook, Hardy & Bacon, Imperial, RJR, RJR-Germany, Japan Tobacco, BAT-Germany, Lorillard, Austria Tabakwerke, Covington and Burling, Tobacco Institute, Brown and Williamson.

The objective of the meeting was "to bring together industry scientists to discuss scientific research and strategies on ETS and how these relate globally." Don Hoel chaired the meeting.

Participants gave national and regional perspectives. Professor Adlkofer noted the increasing activities of anti-smoking groups on the issue of ETS, with Governments and the EEC playing an increasing regulatory role, especially addressed to children’s exposure. More [industry] research is needed to counter these activities.

The existing science demands that the industry recognize that possible health risks from ETS exist because those cannot be disproved. As a result, Adlkofer advocates that research be focused on determining the threshold level of adverse effects from environmental tobacco smoke, and that fewer resources be expended on epidemiological studies.

Dr. Adlkofer deviated from the agenda and discussed the direction of ETS research. According to Adlkofer, analytical breakthroughs are unlikely.... Conventional epidemiology has provided few benefits to the industry. A focus is now needed on "modern epidemiology" and human exposure studies, as well as further exploration of the alleged mechanisms of effect. He also called for the identification of a threshold level for risk. Dr. Adlkofer indicated that this approach has already been adopted in Germany. Dr. Adlkofer’s suggestion created widespread disagreement among the meeting’s participants. Mr. Westcott [Philip Morris consultant] stated that setting a threshold is dangerous because it provides a priori proof of causation for anti-smoking advocates. Mr. Rupp [Covington & Burling] agreed, stating that an acceptable threshold for ETS may nevertheless indict active smoking.... The conference concluded with the finding that existing science could neither prove nor disprove that any impairment of health is caused by ETS. Although a fairly strong position on the relationship of ETS to health effects in children was adopted, the conference concluded that ETS problems in the home are best solved by health education.

# 10 August 1988, minutes, Fink to Osdene, VdC WPA, PM 2050804750 - 4752.

The Vienna hearing was generally favorable to the industry. A VdC "rapid intervention force" is set up. No details. Lawyers on it. Other cadmium salts besides the chloride are shown by the Fraunhofer Institute to be carcinogenic, producing lung tumors..

WHO paper "Tobacco or health" The WHO paper was discussed. It was the unanimous opinion of the committee that only a revitalization of INFOTAB would make it possible to provide a significant counterweight to the coordinated WHO objective.

# 3 September 1988, minutes, Fink to Osdene, VdC WPA, PM 2050804939 - 4940.

A protest by the Austrian Chamber of Physicians against the course of the Vienna Hearing on passive smoking indicated to Dr. Klus (Austria Tabak) that "the statements made about smoking having been correct."

# 29 November 1988, minutes, Fink to Osdene, VdC WPA, PM 2050804670 - 4673.

Research on benzene and ethylene in tobacco, particularly in respect to DNA adducts. Adlkofer notes that high levels of ethylene oxide have been found in non-smokers. Adlkofer talks about beneficial effects of smoking (nicotine, really): social, pharmacological and medicinal.

WPA discusses a "tar predictor" method (by low-temperature combustion) of measuring total tar to be found in a given quantity of tobacco. WPA vigorously opposes the idea as it will yield "higher" tar levels in cigarettes, instead of the value obtained on a smoking machine in graded, timed puffs.

Values obtained by this tar predictor method are at the moment in excess of 200 mg of tar [per cigarette].... In addition, values determined by means of the tar predictor could no longer be used to explain to the consumer any differences in tar and nicotine deliveries which one would experience as a result of ventilation, filters, etc. Finally, the isolated use of the tar predictor for cigarette tobacco in itself raises the problem that the dangers of sidestream smoke in general are apparently demonstrated by the fact that, for a DIN test smoking indication of 12 mg of tar, the conclusion is reached that about 180 mg of tar are evidently being released into the environment (basis for manipulated discussion of passive smoking).

# 22 December 1988, minutes, Fink to Osdene, VdC WPA, PM 2023537689 - 7691.

Intense discussion of cigarette standard measurements, need to stand firmly against the tar predictor method. BAT and other firms will discuss methods at CORESTA.

* 10 February 1989, Dembach memo to R.J. Marcotullio, "ETS -- Industry reaction." RJR 506816587.

German Verband activities in ETS over 30 years have led to "close cooperation with independent scientists from well-known German institutes and universities, [which] has more recently led to a number of publications...characterized by a balanced objective evaluation of the matter." Recent presentations suggest that the "risk of cancer due to passive smoking is not established.... This positive development...might also encourage others in the Company not to give up this issue which is so vital for our future business."

* 20 February 1989, policy review by U. Bluhm and O. Stuhl submitted to Dembach,

"ETS -- Challenge for the Industry." RJR 506816535 - 6543.

"In conclusion it can be said that the German Industry is using a great amount of PR- resources and political lobbying in order to establish its position."

With increasing restrictions on public smoking in Germany the area of contention is in the private workplace and restaurants. The authors worry about EC directives which would apply to all member nations. Verband continues research on animal exposure, dosimetry, epidemiology, and sidestream smoke analysis. All the research results appear to minimize the health risks, minimize the ability to detect such risks ("low risk associations"), or show the limitations of claims about those risks. Toxicological research focuses on individual molecules, such as benzene and ethylene. New research on "risk groups" (e.g., asthmatics, pregnant women) being undertaken. Many German scientists are quoted to support the innocuous role of ETS.

D. Schmael remarked, "Smoking bans are political decisions."

# 2 March 1989, minutes, Fink to Osdene, VdC WPA, PM 2050804489 - 4492.

VdC moving from Hamburg to Bonn. The VdC "concept" discussed. Dosimetry and biomonitoring. A conference in Argentina sponsored by the "Academy of Science," is paid for by PM. [N.B. The usual industry consultants including Adlkofer, Gray Robertson of ACVA- HBI, Rylander Sterling, Ueberla, Witorsch. See # BW 503243382, 503243386 - 3387.] Thioether in passive smoke study discouraged. Study on Parkinson’s disease treatment by nicotine encouraged. "The objective of all investigations must be to show that passive smoking gives health-relevant values which do not fall outside the brandwidths [N.B. "Bandwidths" is meant!] of biological variability."

# 14 March 1989, minutes, Fink to Osdene, VdC WPA, PM 2050804453 - 4456.

Magnussen’s asthma-provocation study is approved. It is expected he will find no effect.

Discussion of joint research: passive smoking, medical exoneration of smoking. VdC needs a scientific spokesman. On passive smoking research:

The opinion is that the research will not be carried out in the same way without the Association. If the VDC were to discontinue its research, the other side [i.e. transnational firms] would also carry out no further research since the matter would be resolved in their favor. In summary, the opinion expressed is that passive smoking is currently our main problem.

# 25 May 1989, minutes, Fink to Osdene, VdC WPA, PM 2028525774 - 5776.

Thioether study to be done with a BAT "slave smoker." Adlkofer expects to find that "the threshold value theory does not yet have to be discarded!" [N.B. Old debate, is carcinogenesis a linear event, i.e. some cases at any dose, or a threshold event, no cases until a certain level reached. US EPA has taken the former with respect to pesticides and many other environmental chemicals. Adlkofer later co-authored a study indicating that diet -- broiled meats -- was the main source of thioethers in the urine in nonsmokers, not ETS. See Scherer G, etal., "Urinary mutagenicity and thioethers in nonsmokers: role of environmental tobacco smoke (ETS) and diet," Mutation Research 1996; 368: 195-204.]

# 7 June 1989, minutes, Fink to Osdene, VdC WPA, PM 2023536371 - 6373.

This is identical to the minutes dated 25 May 1989.

# 24 June 1989, minutes, Fink to Osdene, VdC WPA, PM 2028527932 - 7933.

Passive smoke study in rats, the life-time study: Hoffman of Wynder’s group asks for DM 600,000 to study the effect of diet in the genesis of lung cancer. A "VDC rapid intervention force" is proposed to provide assistance to allies on passive smoking, for public discussion on radio and TV.

The scientific department assumes that no neoplasms will occur in rats even in a lifetime experiment, in contrast to the experiment with diesel exhaust fumes [Fraunhofer Institute]. Prof. Adlkofer emphatically spoke in favor of carrying out this experiment.... However, it must be possible to stop it at any time if required by the member companies.

# 22 August 1989, minutes, Fink to Osdene, VdC WPA, PM 2028526683 - 6684.

The Lock study alleging no change in cancer rates in Hamburg comes under criticism for its statistical approach. The subject of passive smoking recurs:

In Canada, the publication of a report on the topic of passive smoking by Prof. Spitzer is imminent. Prof. A. reported that Prof. Spitzer had been persuaded by John Rupp [Covington & Burling] to prepare this report on the topic of passive smoking. In accordance with the attitude of Prof. Spitzer, this report has now turned out to be "anti" rather than "pro". The view of the WPA is that it was not advisable to make use of this report. [N.B. A note of explanation. The industry’s law firms would typically recruit potential expert consultants by asking them if they wished tor review some aspect of the scientific literature, or documents prepared by industry – for a fee, of course. If the "review" was obviously slanted in favor of the industry, the law firms would interview the consultant and groom them for various roles defending tobacco: as writers, witnesses, speech-givers. Walter Spitzer of McGill "took the money and ran."]

# 30 August 1989, "Statement of the Task Force ‘VdC Life-Time Rat ETS Exposure Study,’ prepared for submission to the VdC Science Policy Commission (WPA)," no author, RJR 507966206.

The Task Force holds the opinion that, based on the 90-day exposure study, a (life-time animal) research project on passive smoking is technically feasible. Such a study would, without any doubts, help to clarify the currently discussed association between passive smoking and lung cancer. If the Industry sees a value in learning about the results of such a study as soon as possible and before others do, they are well advised to have such a study conducted. There is little likelihood that the exposure of animals to ETS will result in an increased incidence of lung cancer. This, however, cannot be completely ruled out. In case, as is expected, that the results turn out to be negative, they could undoubtedly be used in the scientific discussion on passive smoking, anticipating favorable impact. Philip Morris has abstained from voting on this statement.

# 6 September 1989, minutes, Fink to Osdene, VdC WPA, PM 2028526533 - 6535.

Adlkofer presses for the lifetime exposure study in rats – it would last four years. Adlkofer and Klus present preliminary data that after intravenous injection of nicotine no nitrosamine is found in the saliva. PM Germany warns Adlkofer not to publish the results. Statistician P.N. Lee’s contract is extended.

# 7 September 1989, memo, from Lutz Mueller (RJR R&D Scientific Affairs, Cologne, Germany) to A. W. Hayes, Gary Burger, Charles Green, Robert Suber, "VdC Life-Time Rat ETS Exposure Study," RJR 507966203 - 6205.

The 30 August statement above was presented to the Science Policy Commission (WPA) on 31 August. The scientists were concerned that the independent Fraunhofer Institute (see 29 October 1982 on their cadmium studies in rats) would conduct the study. Adlkofer expected the life-time study to show "not less and not more" than the 90-day study, which showed "hyperplastic and metaplastic changes in the dorsal-nasal turbinates [i.e. nose passages], which were fully reversible." Such an inhalation study requires the most meticulous of laboratory settings (Fraunhofer tears down their space, air ducts, tubing, intake and exhaust fittings after each study). "In addition, it was discussed which strain [of rats] would be the one most sensitive, and whether it would be wise to use the most sensitive animal model after all. [N.B. Emphasis added.] The WPA was also concerned about body uptake. The WPA also considered the cost, some DM 4 million. The WPA decided to consult with Francis Roe and Dietrich Schmaehl.

[N.B. Adlkofer was being too carefree: the "metaplastic" changes after 90 days could well presage conversion to cancer with prolonged, "life-time" exposure.]

# 4 October 1989, memo, from Lutz Mueller to parties noted in 7 September memo, above, "VdC Life-Time Rat Exposure Study," RJR 507966238 - 6239.

Apparently Roe and Schmaehl reacted positively to the proposed study, supported by RJR’s Mueller. PM suddenly provided a more critical review by Dr. Wolf Reininghaus, Head of the Inhalation Group at INBIFO (PM’s Cologne-based Research Institute). No decision taken. The Reininghaus document could not be located on the tobacco documents’ websites.

# 15 November 1989, memo, from Mueller to above plus Gary Burger, Charles Coggins, David Doolittle, Arnold Mosberg, "VdC Life-Time Rat Exposure Study," RJR 509638432 - 8433.

The topic was removed from the WPA, at PM’s request, to be discussed further at the VdC Board (made up of the company CEOs). Mueller hopes the Board will "de-emotionalize" the issue. "The alternative would be to give in to the emotional obstacles which have surfaced (and to PM’s basic resistance as well) and to not pursue this study any further."

# 21 November 1989, minutes, Fink to Osdene, VdC WPA, PM 2028526343 - 6344.

All companies except PM are in favor of the long-term passive exposure study in rats.

#20 December 1989, memo, Mueller to above, "VdC ETS Lifetime Animal Exposure Study," RJR 507966291.

At the VdC Board Meeting on December 12, 1989, the controversial subject of the VdC ETS Lifetime Animal Exposure Study was again discussed, this time at the highest level. At this meeting, Philip Morris presented a document which you will find enclosed in English translation. It looks like Philip Morris has dissociated itself somewhat from Dr. Reininghaus’ presentation and is now focusing on the more political questions concerning this study.

# 11 January 1990, minutes, Fink to Osdene, VdC WPA, PM 2028527096 - 7098.

PM rejects lifetime passive inhalation study. PM reports an outside study that now seems

to indicate high levels of dioxin in tobacco smoke. The top ten German brands will be studied.

# 16 January 1990, memo, Mueller to several RJR scientists, "VDC ETS Lifetime Animal Exposure Study," RJR 508947297.

Formally, the study proposal was turned down by the VdC Board on December 12, 1989 by a 3:2 margin (con: PM, BAT, Reemstma; pro: RJR, Brinkmann). Nevertheless, the issue is still alive and has turned up again at the most recent meeting of the Science Policy Committee....The three companies whose CEOs had opposed the study at the VdC Board meeting were asked to explain their reasoning. While this memorandum is not the place to go into details, I have to say that their arguments were very weak indeed."

Adlkofer was asked to take advice from the Chairman of the MAK Commission, Prof. Hentschler, and Prof. Zbinden ("the Grand Old Man of European animal toxicology").

# 8 February 1990, Minutes, Funk to Osdene, VdC WPA, PM 2028526870 - 6873.

DNA adducts, benzene effects on smokers to be studied. Under the heading "Cooperation with Prof. Ueberla,"Ueberla proposes five studies: 1) An opinion survey of German experts on lung cancer and passive smoking; 2) study of all endogenous and exogenous factors which can result in lung cancer; 3) attempt to estimate risk of lung cancer in non-smoker; 4) meeting of experts to determine causes of endogenous cancer in Munich; 5) scholarship support for public health students. Animal inhalation study no longer to be done by VdC.

# 10 May 1990, minutes, Fink to Osdene, VdC WPA, PM 2023536126 - 6127.

Federal Office of Environment complains to VdC about contamination of environment by cigarette filters (i.e., butts) and packaging. Adlkofer wants to do research on a nicotine capsule and gets approval for a preliminary study. It is not said what this is for, but one suspects it is more for the pharmacologic effect and not for quitting smoking. Magnussen’s research shows no effect of acute smoke exposure on people with bronchial asthma.

# 30 May 1990, minutes, Fink to Osdene, VdC WPA, PM 2028531633 - 1635.

WPA now worries about the ethics of Prof. Magnussen’s research. WPA decides that since Preussman, contrary to D. Hoffman’s findings, showed no relationship between nicotine content and the appearance of nitrosamines due to burning, "there was seen to be no need for further VDC activities in this area." The Forschungsrat opposes advertising ban since this will make it impossible for them "to fulfill its informative role in regard to the less harmful cigarette." Problem with titanium dioxide in German CA filters [N.B. No irony intended or observed in the name of these filters.], something that is continuing outside Germany as well. "In view of the present technical and legal situation, PM and RJR see no need for this."

# 20 June 1990, minutes, Fink to Osdene, VdC WPA, PM 2028531456 - 1458.

Benzene taken up by non-smokers from ETS is said to be less than from ambient air in Munich. Magnussen’s research shows no provocation of asthma in asthmatics exposed to passive smoke at high levels (CO 20 ppm).

# 26 July 1990, minutes, Fink to Osdene, VdC WPA, PM 2050803831 - 3834.

Much discussion on the CORESTA plans for regularizing how tar and nicotine are measured and reported. In discussion of smoker’s motivation research project, Adlkofer offers a definition of addiction:

"When an individual is dependent on a certain substance or a certain behaviour to such an extent that the use of the substance or continuation of the behaviour is completely or partly outside of the individual’s control, restricting or eliminating social responsibility on the part of the individual." Fink comments: The WPA feels that this definition is dangerous and could very easily be misinterpreted.

An Adlkofer manuscript on benzene is almost rejected for publication by WPA as "unwise." PM asks that analyses of benzene in ETS be eliminated from the manuscript "since they were obtained under unrealistic conditions (ETS concentrations of 10 and 20 ppm CO [parts per million carbon monoxide]." [N.B. Hugod’s study funded by VdC used 20 ppm CO, Russell’s 1973 study, deliberately using heavy doses of ETS, came up with 38 ppm; 10 and 20 ppm CO is not "unrealistic." See note 4 June 1982. It may not have been revealed to the WPA that a paper on benzene in ETS had just been published by Adlkofer: See Adlkofer F, et al., "Significance of exposure to benzene and other toxic compounds through environmental tobacco smoke," Journal of Cancer Research and Clinical Oncology 1990; 116: 591-8.]

Atteslander’s rebuttal to the Swiss Health Department’s study on "Smoking and Mortality" is criticized by Harold Koenig as one "which could have come from the pen of PM."

(See 9 March 1987.)

# 28 September 1990, unsigned list, "CORESTA SS/ETS TASK FORCE VdC PROPOSALS,"

BW 562400144.

Announcement that VdC will discontinue sidestream smoke analysis, do no development of standard methods for ETS, but simply to be a forum for information and establish an advisory committee "with the precedent of the agrochemicals advisory committee in mind."

# 1 October 1990, memo, Mueller to members of the VdC WPA, "Coresta SS/ETS Task Force Meeting," RJR 507965875 - 5876.

Work on sidestream smoke and its discussion by the Task Force has now virtually come to a halt. It was strongly felt that the ongoing modification of smoking methods (especially the work on ambient airflow around cigarettes) by the CORESTA Smoking Methods Harmonization Task Force has made all current activities regarding sidestream smoke rather questionable. A moratorium of all Task Force work on sidestream smoke was widely supportd by Task Force members (PM-USA, PM-E, RJR, Rothman’s, Tabaqueria, Reemstma, BAT-D). [N.B. The "harmonization" came about as a solution to the Barclay Cigarette controversy, when the Industry agreed on how measurements of tar and nicotine would be reported. See Hirschhorn’s Globalink annotation in BATCODOC4, 15 September 1989, BAT (File AA 0832) 401112655 - 662. This apparently put any further research on smoke nicotine and particulates off-limits.]

# 2 February 1991, telex, from Fink to Robert Pages, "Brune," PM 2024470743.A.

Fink comments sardonically on the failed animal passive smoke inhalation study [ellipses in original]:

Bob: Do you want to buy two SS-inhalation chambers? Yes? Then contact Dr. Brune, Hamburg. The labs of Dr. Brune were closed....The official version is that he has retired. The unofficial version....he had nothing to do after the animal protection law became effective Germany. And now you can put together the puzzle called "VDC SS animal inhalation study." ...good friend Brune went to good friend Schmael asking "can you organize some longterm contacts for me? ...good friend Schmaehl said "certainly, I have a good friend Adlkofer" ...good friend Adlkofer said to Schmael, "no problem, the stupids of the cigarette industry will do what I propose. How much money does your good friend Brune need for the next 4 years..4,5 or 6 millions?" ...good friend Schmael went to good friend Brune and told him and they opened one big bottle of champain [sic] (or possibly two because they had to give some cheers to good friend Adlkofer) and they celebrated and they were doubled up with laughter.. These bastards of PM do not appreciate a joke..

* 5 April 1991, memo, Mueller to Charles Blixt, A.W. Hayes, John Robinson, "VdC Statement on Nicotine Addiction," RJR 508302193 - 2194.

The European Commission proposed that labeling include the phrase on cigarette packs, "Smoking causes addiction." "The German wording is ‘Rauchen macht abhangig,’ literally translated: ‘Smoking makes you dependent’.... a fairly soft expression.... A much stronger word in German would be ‘Sucht’ or ‘suchtig but, interestingly enough, this was not used...."

# 8 April 1991, minutes, Fink to M.C. Bourlas, VdC WPA, PM 2028527873 - 7875.

More on CORESTA and on German pesticide regulations. Research on "smoker motivation" compares steady smokers and ex-smokers. No details given.

# April 1991, meeting notes, in German, VdC WPA meeting, unsigned, PM 2028531816 - 1822.

Report on CORESTA meeting. Adlkofer presented his scientific views on passive smoking to a German interministerial council, and the discussion became quite controversial, and WPA was concerned that an "unscientific" report might come out of the council, with a Mr. Junge and Professor Seifert of the Federal Health Department leading the effort. Various other topics discussed, including a study proposed by Dr. Adlkofer of confounding variables in the causation of lung cancer among smokers and non-smokers. A proposal to review passive smoking in smoking is tabled.

# 11 June 1991, minutes, Fink to Bourlas, VdC WPA, PM 2028531825 - 1827.

American Health Foundation (Wynder) submits proposal to study epidemiology of lung cancer in Japan and USA, with budget of USD 360,000.

# 18 June 1991, minutes, Fink to Bourlas, VdC WPA, PM 2028533162 - 3164.

Wynder’s research proposal on confounding factors causing lung cancer (diet, cooking habits, other kinds of pollution, social status and alcohol) submitted to Forschungsrat and WPA, approved at USD 360,000. P.N. Lee and Prof. Ueberla revising protocol. On co-opereation between member companies and VdC: "PM, RJR and RE believe that it is necessary to make greater attempts to communicate objective information derived from VDC research projects to support the uncertain consumer." [N.B. Irony of this statement not noted.]

* 3 July 1991, telex, from Bob Pages (PM counsel) to Steve Parrish (VP PM International), "Forschungsrat Foundation," PM 2023246072.

Walter Fink has advised Pages that the German Research Council (Forschungsrat) on Smoking and Health may turn itself into a foundation.

The idea is to try to broaden their activities while at the same time trying to better control/guide their efforts so they don’t pursue long-term programs we don’t like.... [T]he model concept for the Foundation that is currently being discussed would mean that the industry would have less control.... Walter says that the PM position should be that we are, not, in principle, opposed to a foundation, but that the foundation’s charter (or whatever) must be structured such that we can guide/control what they choose to do with the money.

# 31 July 1991, minutes, Fink to Bourlas, VdC WPA, PM 2023536658 - 3660.

More on CORESTA "Harmonization of Smoking Methods," and its imminent publication.

On the Interministerial Working Group on passive smoking, the report by Neidert and Junge "is very one-sided and unscientific. None of the comments and corrections made verbally and in writing by Prof. Adlkofer have been considered by the authors." Scherer in Adlkofer’s lab asks for funding to extend his study on DNA adducts; it is revealed that the original study had not been approved by the WPA, which approves the extension nevertheless.

* 1 October 1991, telex, Robert Pages to Charles Wall, "WPA meeting of September 26, 1991," commenting on a memo from Walter Fink to Pages, attached, PM 2023222878 - 2880.

Pages briefs Wall on the latest "tempest" with Adlkofer and WPA. It began with Adlkofer’s report in January 1991 to WPA that Dietrich Hoffman (American Health Foundation) determined that nicotine is metabolized to produce nitrosamine within the body, and would present the results in Hawaii in October 1991. WPA approved secret research to determine it for themselves. The first results were reported negative: looking for endogenous nitrosamine generated from nicotine by attaching a radioactive tracer on nicotine administered to volunteers. A poster abstract was submitted to the Hawaii conference. It turned out, subsequently that in one of the smokers out of ten tested, there was indeed endogenous nitrosamine discovered; but Adlkofer would not revise the abstract ("could be an artifact"). Then, as Fink described, three more of the ten smokers’ were found positive. The WPA decided to present the original negative results and "project work terminated." Fink continued his report:

After this WPA (all members + Dr. Koenig) [Koenig recently made scientific director of VdC] decided that poster presentation will not be given and A. and his coworkers are not allowed to participate in the Hawaii meeting. As "sensitive" results generated by the Munich Lab (established to work on sensitive issues) are distributed by A., the future of the Munich Lab will be discussed. The situation after 24 September is comparable with the situation under Dontenwill. Will the consequences be the same?

Lawyer Pages minimized the scientific finding:

I don’t think that the detection of a compound in the urine of SOME smokers ‘proves’ anything about the hypothesis. It may be consistent with a proposed chemical or metabolic pathway, but it does not by itself prove the hypothesis.... (That’s my view of the science; newspaper media coverage devoted to these results may be quite something else.)

[N.B. In 1975, the Verband closed its Research Institute laboratory, leasing the facility to the German Government for a nominal one DM a year. According to the 1980 BBC Panorama program exposing the practices of the British American Tobacco Company, Verband did so because the Institute’s Director, Professor W. Dontenwill, had demonstrated laryngeal cancer in hamsters inhaling cigarette smoke (W. Dontenwill, et al. Journal of the National Cancer Institute 1973, vol. 51, 1781-1832), and cardiovascular disease in pigs. According to Panorama, a secret Verband meeting pensioned off Dr. Dontenwill with 1.6 million DM, the equivalent of ten years salary. The Research Institute was replaced by an "independent" research funding agency supported by the German and transnational cigarette industry, with a Research Council used to approve research proposals coming from various scientists and institutions.]

# 5 November 1991, minutes, Fink to Bourlas, VdC WPA, PM 2028455070 - 5072.

Professor Schmidt’s proposed study on birth outcomes of pregnant smokers was rejected in its present form. More on the Interministerial Working Group report on pasive smoking:

The one-sided and unscientific report on passive smoking by Neidert and Junge.BGA (statement: passive smokers get lung cancer substantially more frequently than people exposed to asbestos)...will form the basis for decisions with regard to future health policy measures in Germany. In view of the situation, it was decided to increase efforts in the political arena to ensure a more objective discussion. As a first step, a meeting has been arranged with Mrs. Hasselfelt of the Ministry of Health for the end of September [sic].

# 19 November 1991, minutes, Fink to Bourlas, VdC WPA, PM 2028455043 - 5045.

In discussion of VdC "research concept" paper: "PM and RJR pleaded for the inclusion of the areas "Smoker’s Environment" and "Alternative Causes of Disease" with simultaneous inclusion of the VDC research in a more political oriented research concept."

CORESTA’s ETS task force decides not to use nicotine in ambient air as a measure of ETS. CORESTA had already decided against further experimental work on sidestream smoke analyses. "WPA discussed the question of the scientific value of sidestream smoke analyses. In general, this activity is not believed to be necessary."

* 11 December 1991, telex, Robert Pages to Charles Wall, "Research – VDC Forschungsrat," PM 2023223420.

Pages asks Wall not to distribute the list of VdC-funded projects (see 1 September 1991). Only four copies exist.

* 21 December 1991, R Pages memo to Charles Wall, "VdC/Forshungsrat." PM 202322342.

Philip Morris secretly obtains list of Forschungsrat projects, and Pages asks Wall to be discreet as it apparently conveys some advantage to PM over the other companies. Adlkofer manages to make secret deals with each company in turn.

[Walter Fink] hopes that you will not widely distribute the list of Forschungsrat projects because of its confidentiality and the conditions under which he was able to obtain it (private agreement between Fink and Adlkofer over the protest of Brueckner).... At the next meeting of the WPA at the Verband...there will be a discussion of the general subject of how to handle requests by member companies for information on Forschungsrat projects.

* 29 January 1992, R. Pages memo to Steven Parrish (in 1995, Senior Vice President of Philip Morris for Worldwide Regulatory Affairs), "Subject: Wynder proposal to VdC." PM 2023222815 - 2816.

Ernst Wynder asked Verband for $500,000 for a two year epidemiological study of lung cancer in Japan and the United States. Pages asks,

What do we gain if we support the study? It very likely [will] provide helpful data on both the primary and ETS issues. In the primary area, it should provide additional data on the importance of dietary and possibly familial factors which are associated with the incidence of lung cancer. (The differences in the dietary habits between Japanese and Americans, especially in the consumption of fats, is the key aspect of the study.) In the ETS area, the investigators will look at misclassification of ever smokers as never smokers and to what extent such misclassification may have contributed to the results reported by Hirayama [N.B. A hand-written marginal note helpfully explains, "ever smokers get lung cancer"]. They will also examine to what extent uncontrolled confounding by other factors (diet, familial history of lung disease, etc.) May be responsible for the weak associations between ETS exposure and lung cancer reported by some studies [N.B. Hand-written note: "This is key."]. Down-side: I really don’t see any.... Wynder is the key. Final recommendation: You (or Chuck [Wall]) should telephone Adlkofer to let him know of PM’s decision. [N.B. Philip Morris may have bought second-hand smoke. Here in its entirety is the abstract of a paper published by Ernst Wynder with Takashi Hirayama as a co-author (!) and published in 1991 (Cancer, volume 67, 746-63):

Vital statistics were examined for the years 1955 through 1985 for Japanese natives and United States whites to elucidate changes in cancer mortality and related antecedent patterns of life-style in these two populations. Results show that lung cancer rates are rapidly accelerating among Japanese males as a consequence of their prior history of heavy cigarette smoking. Oropharyngeal cancer rates are also rising in Japan paralleling increases in alcohol and tobacco utilization. As the Japanese life-style and diet continue to become more "westernized," the rates of malignancies of the breast, ovary, corpus uteri, prostate, pancreas, and colon also continue to rise. Nevertheless, the mortality patterns of certain malignancies, viz., laryngeal, esophageal, and urinary bladder cancer, are discrepant with their established risk factor associations, suggesting the existence of other differences in risk factor exposure between the two countries. Epidemiologists and health educators need to develop innovative international programs of investigation and health promotion with preventive impact on common malignancies associated with risk-factors of life-style.]

It is not known if Wynder was funded. Search of the literature through 1998 shows no further publication by him about the epidemiology of lung cancer in Japan.

# 30 January 1992, minutes, Fink to Bourlas, VdC WPA, PM 2050803525 - 3528.

The decision to withdraw the poster on nitrosation of nicotine at the Nitrosamine meeting in Hawaii (Dr. Tricker) when four persons dosed with radioactive nicotine were found to have nitrosamine in the urine "was subsequently reversed after repetition of the experiments had shown that endogenous nitrosation of nicotine can certainly be ruled out." [N.B. The argument over endogenous metabolism of nicotine to nitrosamine - which does occur, particularly NNN - overlooks the fact that tobacco-specific nitrosamines are abundant in mainstream and sidestream smoke. In this saga of the Hawaii poster, Tricker was first forbidden to go to Hawaii and then permitted to do so only when his results were reversed.]

# 10 March 1992, minutes, Fink to Pages, VdC WPA, PM 2028344068 - 4070.

Discussion of drafted "VDC Research Concept" (see below) – a public relations effort to define VdC work. German Federal Health Ministry decides that passive smoking more dangerous than asbestos, despite pleas from Adlkofer. In one respect, the Ministry wanted to damp down the hysteria over asbestos.

Prof. Magnussen’s research on exposing children and adults with asthma to passive smoking was discussed [N.B. The results, on airway responsiveness after an hour of ETS, were largely unremarkable, except for those smokers known to be smoke-sensitive, but the political fallout of such research was serious; see 1, 4, 25 October 1992, PM 2047903790, 2047903795, 2023222729. The PM executives said, "We deplore such tests, especially when conducted on children," ignoring the obvious irony that the Industry sees nothing wrong with ETS except annoyance! See also Magnussen’s articles, Clinical Investigation 1992; 70: 368-71; European Respiratory Journal 1992; 5: 936-44; Journal of Applied Physiology 1993; 75: 553-8.]

[T]he video of an NDR talk show was shown in which Prof. Magnussen commented very strongly against active smoking and, in the matter of passive smoking, also made comments on the ETS exposure of children suffering from asthma which were entirely in contradiction to the results of his previous studies financed by the VDC.... Prof. Adlkofer explained the circumstances which led to the expansion of the laboratory. In a very emotional discussion, it emerged that PM and RJR wanted detailed information about the projects being carried out and the planned future developments before agreeing to the expansion.... Prof. Adlkofer took this as evidence of personal distrust.

A planned new foundation, separate from VdC, "VERUM" is broached here for the first time. PM objects because of difficulties approving "private" research by members of the VERUM Board of Trustees.

# 7 April 1992, minutes VdC WPA meeting of 19 March, in German, unsigned, PM 2028527468 - 7476.

One remarkable note has it that RJR pledged $70,000 support to Ernst Wynder in an unspecified epidemiological study in addition to the existing $200,000 grant. [N.B. A study on lung cancer in Japan compared to USA; see 20 May 1992.] Although the project is not specified, it is clear that Wynder’s estimable standing as a scientist serves smoking well, especially where science and politics coincide. BAT asks that more questions on passive smoking be included.

* 9 April 1992, Charles Wall letter to Paul Hendrys (Philip Morris-Germany), "Re: Philip Morris Research." PM 2050803435 - 3439.

Discusses Verband research PM is supporting, 34.5% of the current Verband research budget. The budget amounts to 7.1 million DM. Research proposed for 1992 include Ernst Wynder’s epidemiology study for $500,000, and a study of active and passive smoking on pregnant women.

# 10 April 1992, report by Lutz Mueller (RJRTI Cologne), "The scientific department of the Verband der Cigarettenindustrie." RJR 515997765 - 7767

Perhaps Mueller was better connected to Adlkofer than Colby or Pelz or Dembach; the tone of this report is much more positive about the Verband and Adlkofer. Apparently, the Verband laboratory had been reestablished sometime in the 1980s, and situated in Munich, with seven scientists (three with PhDs.). Much work on passive smoking, and a new promise of cooperation with RJR in Winston-Salem is made by Adlkofer.

While the quality of the Scientific Department’s desk and laboratory research aims at an international level, the thrust is predominantly to influence scientific and political opinions and developments in Germany.... As a person and scientist, Dr. Adlkofer is very well connected both with many reputable international scientists as well as leading scientific and political figures who are important for the Industry in Germany.... With the exception of one or two anti-smoking zealots, Dr. Adlkofer is accepted by and in a position to talk with practically every scientist and government official in Germany. His access to many international scientists is remarkable.... I have great difficulty to imagine the Verband working in the way they do now without Dr. Adlkofer as the head of the Verband’s Scientific Department.

12 May 1992, minutes, Fink to Pages, VdC-WPA, meeting of 19 March, PM 2028344059 - 4062.

The new foundation succeeding the Forschungsrats Rauchen und Gesundheit is to be called "VERUM" (Stiftung für Verhaltung und Umwelt, Behavior and Environment Foundation). [N.B. An article in International Journal of Hygiene and Environmental Medicine 1997; 200: M2 by anti-tobacco activist Prof. Dr. med. F.J. Wiebel describes the foundation. Five-sixths funding directly from the VdC, one-sixth from interest on the endowment. VERUM’s real work is intended to distract from the real problem of passive smoking as an environmental hazard.]

Tobacco smoke effect on biological parameters in humans rancorously discussed ("deception," "blackmail") but still not off the ground. [N.B. This English version of this same meeting described in German does NOT mention the Wynder project and dollar support!]

* 20 May 1992, report, Charles Wall to W. Murray on research expenditures, page 8 of 14, PM 2022850500.

To the best of my knowledge, the Wynder proposal remains unfunded. You may recall that VdC has budgeted 250,000 DM each year for two years, and would like Philip Morris, R.J. Reynolds and British American Tobacco to come up with a total of 60,000 DM each year, for the next two years. You may also recall that this is an epidemiological study of lung cancer incidence in Japan and the United States.

* 1 June 1992, one-page promotional brochure, "VdC Concept," with hand-written comments on text by Anthony Andrade (Philip Morris in-house Counsel), "Tobacco is a semi-luxury product to be enjoyed but more than just a matter of taste," and illustrated with an 18th century snuff box and a tobacco plant. . PM 2501200120.

Handwritten heading: "PM-Germany." Printed text, two columns, one column hand- underlined and encircled:

Pleasure also has a lot to do with good, sound common sense. On first sight that may seem a paradox. However, even the philosophers of ancient Greece, Epicurus and Plato with their widely differing doctrines agreed that pleasure should above all be taken in moderation. Satisfaction and enjoyment are the fruits of a healthy balance between common sense and sensual fulfilment. Moderation is the highest principle governing all things, including pleasure. As a leading cigarette manufacturer, Philip Morris supports pleasure in moderation. Immoderation and excess stifle the experience of good taste and true satisfaction. Sensible smokers with good common sense derive real pleasure from moderate cigarette consumption. They are responsible adults who are able to judge for themselves what pleasure is, who understand the risks involved and know what is right for them.

Hand-written comments in margin:

Moderation Argument. 1. What is "moderate cig. consumption"? 2. At what amount does smoking become "excessive" and a risk to health? 3. We can’t say moderate smoking is part of a "healthy balance." 4. Obvious problems that flow from suggesting that there is a magic line of demarcation separating safe smoking from unsafe smoking. 5. Reassurance of safety re moderate smoker; admission re heavy smoker.

* 3 June 1992, translation of a concept paper, Beecken to Parrish and Wall, "VdC Research Concept," with marginal notes by an handwriting that looks like Anthony Andrade’s, PM 2501192695 - 2697. See memo of transmittal Beecken to Andrade, * 10 June 1992, PM 2501192694.

The German cigarette industry actively participates in the discussion about scientific health policy and social aspects of smoking. [Hand-written marginal comment: We would not want to make such sweeping statements in view of Cordova; we can say we will encourage publication of research results in scientific journals] .... By means of its own research as well as through continuous cooperation with scientific institutions outside of industry, the cigarette industry acquires knowledge which contributes to an objective discussion of the topic "smoking and health". [Hand-written marginal comment: we do not want to commit to a discussion].... For consumers, smoking is – if moderate – one of life’s pleasures. The present conception assumes that the smoking of cigarettes will continue in the future to be enjoyed by many people who do not want to refrain from smoking. {Hand-written marginal comments: if not moderate, then what happens? We cannot make the moderation argument].... Basic medical research to identify other non- tobacco exogenous and exogenous factors which may be related to the possible effects of smoking. [Hand-written marginal note: this is a claim in Cordova; this should not be explicitly stated but should be accomplished in investigating the [?] relationship between smoking and certain diseases] The results of national and international research including that carried out by the VdC must be comprehensively and understandably communicated to the public. [Hand-written marginal note: we do not want to assume this burden! It undermines our position re general [?] when we talk about a controversy in a suggestive, affirmative manner]

* 3 June 1992, translation of a concept paper, Beecken to Parrish and Wall, "VdC Research Concept (Final Draft)," with extensive emendations, handwriting looks like Anthony Andrade’s, PM 2501192702 - 2703.

The German cigarette industry actively participates in the discussion about scientific health policy and social aspects of smoking. [Struck out: with the aim of extensively and objectively informing consumers about its products.] By means of its own research as well as through continuous cooperation with scientific institutions outside of industry, the cigarette industry acquires knowledge which contributes to an objective discussion of the topic "smoking and health". [Hand-written marginal note: public relations tool; research designed to give the industry an argument to lobby politicians and tell the public] Basic medical research to identify other non-tobacco exogenous and exogenous factors which may be related to the possible effects of smoking. [Struck out: non- tobacco].... [Hand-written marginal note: Question: do we want to modify the language in the event this doc. ever shows up in the files of [?] tobacco industry employees ? Publicly available] .... The public discussion of the theme of smoking and health is very often carried out in the absence of sufficient specialist knowledge and is frequently based upon emotional [?] unscientific discussion. In the interest of society, this tendency must be opposed. [Struck out: The results of national and international research including that carried out by the VdC must be comprehensively and understandably communicated to the public.]

* 23 June 1992, letter, Anthony Andrade (PM counsel) to Ulrich Beecken, PM 2501192704 - 2705.

Important legal advice concerning tobacco industry research, and the degree of responsibility borne by the industry to disclose its findings.

Please find enclosed the following: (1) A copy of Judge Sarokin’s decision in Haines addressing industry sponsored research; (2) a copy of the complaint in the Cordova case and ; (3) copies of newspaper articles regarding the grand jury investigation concerning the fraud allegations related to industry sponsored research on smoking and health. I believe these materials illustrate the sensitivity of several issues raised in the original language of the VdC Research Concept document. For example, article 4 of the VdC Research Concept would place an affirmative obligation on the VdC to inform the public regarding "the results of national and international research." Unfortunately, anti-smokers will never be satisfied with the amount of information given to the public and could very well allege that certain information was "withheld" from the public in an attempt to "deceive and mislead" the public about the alleged health effects of smoking. Thus, it is preferable not to impose on ourselves an extremely broad and vague duty to inform the public. Instead, it might be better to simply require that the results of the research funded by the VdC be published in scientific and medical journals. A second criticism of industry sponsored smoking and health research that is raised in the enclosed materials is the claim that the tobacco industry intentionally funded research aimed at identifying non-tobacco risk factors for those diseases statistically associated with smoking. It is alleged that this was an attempt to avoid sponsoring research directly related to whether or not smoking caused certain diseases. Furthermore, it is alleged that research investigating other risk factors that could be responsible for the diseases statistically associated with smoking was an attempt to divert the public’s attention away from the health effects of smoking by funding research that is "irrelevant" to the central issue. For these reasons, the main themes in Section III (4) and (5) could be mischaracterized as sponsoring research aimed to "mislead or deceive" the public about the risks of smoking by suggesting that other risk factors are responsible for diseases that have been associated with smoking. This does not mean that such research should not be sponsored since it obviously is directly relevant to the general question of whether it is smoking or any one of a number of other risk factors that may be responsible for a particular disease. However, it is probably wise not to highlight these themes in the VdC Research Concept. [N.B. "Haines vs. Liggett Group, Inc." was the 1992 case where a federal judge ruled that attorney-client privilege could not shield a document from discovery if there was prima facie evidence of fraud being hidden. The ruling was overturned on a technicality.]

# 15 July 1992, report, "VDC Scientific Research by VDC and Research Council," unsigned, PM 2024965645 - 5710. An earlier version # April 1992 is at PM 2028372531 - 2547.

Lengthy report in overheads style giving VdC structure, staff, budget, public relations and legal work, trade relations and business development, science and research, and fiscal matters (taxes and customs). An earlier, thinner version titled "VDC German Cigarette Industry Association Structure and Progress Report," is dated April 1992, PM 2028372531 - 2547. Both documents appear to be a translation from the German by a non-native English speaker. The five departments of the VdC have a company member staff assigned to each. Public relations, legal issues and business development have assumed greater importance under current management.

"The [scientific] group represented by Dr. König and Prof. Adlkofer has received acceptance by the German Health Ministry and is treated as a fair discussion partner, although the treatment by the Ministry is not always cooperative."

The Scientific Political Committee (WPA; previously the translation was "policy") links research "in accordance with the strategic direction determined by the Board." Under the display, "VDC Scientific Research Concept" we find, "The first priority for the research concept of the VdC has to be that [the] cigarette industry offers products to its consumers which can be safely enjoyed." The areas of research priorities include analyses of mainstream and sidestream smoke and their biological effects, nicotine research, social and behavioral research on starting and quitting smoking, research into the behavior of anti-smoking groups ("groups and individuals against the smoker"). 1 February 1991 VdC relocated from Hamburg to Bonn.

Abstracts of VdC sponsored research are supplied, as presented at the 6^th Scientific Symposium in Titisee, February 1989: 1) Smoking increases certain blood-pressure related hormones; study of nicotine on rats’ nervous system; risk factors for atherosclerosis (smoking being one of several); 2) low-density lipoproteins in smokers might be more prone to stimulate white blood cells uptake of cholesterol with formation of atherosclerotic plaques; 3) study on the structure of lung cells; 4) a follow up study to the MONICA study of atherosclerosis, looking at atherosclerotic plaques in leg arteries, with statistically highly significant (p <0.001) risk factors being smoking, diabetes or past history of heart disease or stroke, and less significantly (p< 0.05) correlated with hypertension and total cholesterol; 5) sidestream smoke analyses (Grimmer) finding PAH, nitrosamines, pyridoindoles; 6) and 7) nicotine inhibits chemicals mediating inflammation which may inhibit white blood cell function; 8) nicotine doesn’t inhibit cilia in the lung ("cilioinhibitory effects of cigarette smoke must be due to components other than nicotine.") 9) cell culture research; 9)nicotine metabolism; 10) rat brain glucose metabolism during chronic nicotine infusion (increased); 11) hypersensivity of the respiratory tract in people with asthma from smoking to smoking (Magnussen); 12) chronic nicotine in rats increases salivary gland secretions; 13) chronic nicotine exposure in men appears to decrease cardiovascular responsiveness to a mental stress test; 14) nicotine might increase the effect of anti-cancer drugs in rats; and several other more abstruse abstracts.

* 20 July 1992, Activities report from J.K. Wells (in-house counsel) to M.J. McGraw (in-house counsel), Brown and Williamson 00008-48313-0002. "

We attended the July meeting of the tobacco product litigation counsel in London, including preparation which consisted of reviewing materials and conferences with John Rupp of Covington, Tom Bezanson of Chadbourne, Jim Newsom of Shook, Hardy, and Sharon Boyse of BATCo. At a separate, select meeting a proposed public announcement by the German Verband ...regarding its scientific program was revised to avoid claims similar to those made against the U.S. industry in Haines, including counsel for BATCoI[ndustries], BatCo, Reemstma, PM, RJR, and B&W.

* 28 July 1992, memo, Beecken to Beeken, final version of the VdC research concept after editing, PM 2023245782 - 5783, and "VdC Research Concept (Final Draft)," Mueller to D. W. Donahue (Joint Defense Counsel), PM 2501139395 - 9396..

All of Andrade’s objections taken into account.

# 24 August 1992, minutes, Reif to Pages and A. Kassman, "Meeting of theWPA," PM 2028392508 - 2512.

CORESTA, pesticides, additives, research concept, VdC’s new foundation, passive smoking on airplanes, discussed in rather general terms. Reemstma found only 1/500th the amount of dioxin in smoke as found in a recent Japanese study. The new foundation to focus on effect of nicotine, with or without tobacco, passive smoking, nicotine in the tobacco plant. Discussion on new EC rules on additives and how Austria would now have to obey them on joining.

# 25 August 1992, minutes, Fink to Pages, VdC WPA, PM 2028527352 - 7354.

With implementation of a Government upper limit for total nitrosamine exposure in the workplace, Adlkofer wants the study by Klus to be published. The WPA insists on a "revised manuscript" and approves it with "considerable misgivings," because of the "extremely high ETS levels under which the tests were carried out." A new study of smoking and skin wrinkles is approved. A presentation by Dr. Tricker and VdC on ETS nitrosamines at the American Cancer Society meeting (August 24, 1992) is censored by RJR and PM. Research proposal to study dioxin in the fat of smokers and non-smokers is turned down: "WPA does not see the need of carrying out the study...." Another study by Prof. Rajewski (University Hospital, Essen) on genotoxic effects of tobacco smoke is considered and tabled.

# 4 September 1992, minutes, Fink to Pages, VdC WPA, PM 2028344054 - 4058.

The revised VdC Research Concept is presented and discussed. Despite its approval earlier by PM’s counsel Andrade, PM Germany (Beecken) could not give a final opinion. Rajewsky’s proposal approved.

# 10 September 1992, report by Lutz Mueller (RJTI Cologne), "Verband der Cigarettenindustrie...." RJR 508304351 - 4371.

Mueller makes a complete summary to his superiors. Verband in 1992 comprised Philip Morris, Reemstma, BAT Germany, Martin Brinkmann, RJR Germany, H. van Landwyck, Austria Tabak, and three smaller companies. Harald Koenig was Managing Director. Five departments: General activities, trade relations, marketing, public affairs, and the Scientific Department. Franz Adlkofer headed the Scientific Department, Gerhard Scherer the laboratory in Munich, which was continuously enlarging. Passive smoking was the main thrust of the laboratory. "RJR’s and the VdC’s approach [to ETS research] are remarkably similar, resulting in growing cooperation and mutual support in certain research fields." The German "Research Council on Smoking and Health" was converted to the "independent" foundation "VERUM". Special research studies supervised by Verband included: Wynder’s "Epidemiologic study on lung cancer in Japan and the US," Jurgen v. Troschke’s studies on human smoking motivation and benefits, Nancy Haley’s study on nutrition and cancer (at Wynder’s American Health Foundation) and others on consumer perception, labeling, taxation, and "a PR exercise on passive smoking."

* 1 October 1992, list, Beecken to Knox, Millington, Scanlon, Schwartz (counsel), "Research Council S&H projects," PM 2023222625 - 2628.

Thirty-nine projects are listed, along with the principal investigators. They range from methodology to basic research to animal research to human biology and epidemiology. Hardly any details given.

* 1 October 1992, Lutz Mueller (RJR-Germany R&D) memo to Charles Blixt (RJR in-house counsel), "Subject: VdC research with human subjects: ethical implications." RJR 508478285 - 8286.

Writer worries about research by a Prof. Magnussen -- who had been supported by Verband -- on eleven asthmatic children, which was accused by a national television magazine program, "Monitor," as being unethical. Verband will discuss its role in supporting observational studies in ETS, and PM should as well.

* 1, 4, and 25 October 1992, Craig Fuller (Philip Morris senior vice president) draft statements to T. Collamore, "Draft Statement for use in the event of question being raised about experiments in Germany." PM 2047903790, PM 2047903795, PM 2023222729.

The second draft is quoted, with interpolations the hand-written changes on the 25 October draft.

In response to questions concerning experiments conducted in Germany to determine the effect of secondary tobacco smoke on people [adults as well as children], Craig I. Fuller, Philip Morris Companies’ senior vice president for corporate affairs, said the following. [We deplore such tests, especially when conducted on children, and] When we learned in mid-September that the tobacco association in Germany had supported these tests, we requested [demanded] an immediate halt to any such current or planned projects. At the end of September, Verband, the German tobacco association voted in unanimous agreement with our position." Philip Morris Companies learned of these tests through press accounts. Local Philip Morris officials in Germany had expressed their concern about the proposed research; however, the tests were conducted over their objections. Also [particularly] troubling is the fact that the tests were conducted without proper government authorization. The fact that the tests involved people [children] aging in range from 8 to 66 [strike last seven words] and the failure to gain proper authorization caused the Company to call for a prompt halt of any similar projects in which the industry might become engaged.

* 2 October 1992, telex, Beecken to Charles Wall, "Prof. Magnussen," PM 2501004089 - 4090.

Reviews the various studies done by Magnussen funded by the VdC Research Council.

* 5 October 1992, memo, Beecken to Wall, "Professor Magnussen," PM 2501004085 - 4086.

Two of Magnussen’s research projects were defunded "after the Magnussen TV- presentation," (in which he attacked smoking and warned against passive smoking).

# 29 October 1992, A.R. Tricker meeting report,"Lufthansa Working Group meeting held in Bonn at the Verband...on the 29th October 1992." PM 2028392902 - 2904.

Prof. Adlkofer discussed the proposed ban on smoking on Lufthansa domestic flights, which the airline considered only on economic grounds and "currently developing international trends." The Ministry of Transport considered health issues, commissioned the Junge Report that supported that emphasis. Verband considered the Junge Report "a biased view." Research was recommended on air quality on Lufthansa planes, and specific components, "to win time against a smoking ban." Verband hoped to use "recommended WHO guidelines" [on air quality] to show that levels produced by cigarette smoking (especially after improved ventilation systems) were not "toxicologically relevant." The Verband concluded "to consider the concept of ‘within recommended WHO guidelines’ which appears to be the only longterm solutions to prevent smoking bans on aeroplanes and in other environments, for example, smoking at the working place."

# 11 November 1992, minutes, Fink to Pages, VdC WPA, PM 2023536896 - 6898.

The bylaws and financing as well as the future research activities of the [VERUM] Foundation were discussed. A solution which was satisfactory to the majority of the VDC member companies was...for the case where research projects which adversely affect the interests of the founders were carried out using external funds.

VdC contributed an initial DM 3 million, annual Dm 3 million envisaged, and DM 750,000 transferred to the capital stock for replenishing capital.

A Swedish study now shows much higher dioxin levels in smoke than did Reemstma’s.

# 12 November 1992, minutes, Reif to Pages and Kassman, "Meeting of the WPA," PM 2028527985 - 7987.

ERGO, the lab associated with Reemstma will continue looking at the dioxin question. Magnussen chastised but not punished by the German Ethics Commission for his study with asthmatic children exposed to ETS. With respect to future VdC research:

There was strong acceptance that any future research should (1) focus on real-life studies (case-control studies, field studies), (2) avoid artificial experimental situations where results cannot be used to explain real exposures, and (3) refrain in principal from the involvement of human probands [i.e., experiments on human subjects].

# 23 December 1992, telex, Beecken to Wall, "VdC Foundation VERUM," PM 2501180727 (portion redacted).

Details of governance and financing. "In general and in the statutes the influence of the cigarette industry is rather limited and restricted to the two areas of fundamental interest."

# 8 January 1993, telex, Andre Reiman to Beecken, PM 2501188735.

Upon receiving translation of VERUM statutes, PM official says, "I am of the view that the best response is no response. We will end up in a long and entirely unproductive dialogue."

# 11 January 1993, "Foundation Charter of the Verum Foundation for Behavioural and Environmental Research," PM 2501188768 - 8788, and the "Deed Concerning the Creation of the VERUM FOUNDATION," PM 2501188765 - 8767.

VdC establishes and endows VERUM. Adlkofer gets to pick the Board of Trustees, choosing two and having three academics "elected." The Board is the "supreme body of the Foundation." The Scientific Advisory Board of seven to twelve members will be selected by the trustees, and meet at least once a year and on demand. Prof. Joseph Kaiser, Kurt Kochsiek Gotthard Schettler, Rupert Scholz, Klaus Thurau are the designated trustees, all academics. The words tobacco and smoking do not appear.

# 11 January 1993, memo, Beecken to Wall, "VERUM Foundation," PM 2501188764.

Points out that the charter "reflects the idea that the industry has no direct influence on the research being supported by US foundations. In all other cases the Board will decide by majority which means that the scientists have a majority of 3 to 2."

* 12 January 1993, partial memo, Beecken to Juchatz, Klenman, Pepples, Stevens, Wall (counsel and joint defense counsel), PM 2058135580.

VdC research to take four directions: investigation of nicotine alone or with other substances on human health; investigation of ETS on human health; toxicological effects of [free] radicals on human health; research into the metabolism of tobacco plants and means to affect it.

* 13 January 1993, memo Andrade to Beecken, "Draft paper from the VdC describing the purpose of the VERUM-VdC Foundation," PM 2023245774 - 5775.

Compares the deliberately vague statement of purpose in the VERUM charter and Deed, compared to the stress on health in the document noted above. Seems to be resigned to the whole affair.

# 8 February 1993, minutes, Reif to Pages and Kassman, "Meeting of the WPA," PM 2028455639 - 5641.

Rylander’s proposed study on diet and genetic predisposition as causes of lung cancer is unanimously accepted. [N.B. Three papers have recently been published by Rylander et al.:

1) "Dietary factors and lung cancer among men in west Sweden, " In. J. Epidemiol 1996; 25: 32-9, a case-control study in which is shown that lung cancer patients ate fewer vegetables, drank more milk but ate the same amount of fruit. 2) "Lung cancer, smoking and diet among Swedish men," Lung Cancer 1996; 14 Suppl 1: S75-83, is the same study published a second time! Here, however, lung cancer was related to the amount of cigarettes smoked. 3) "Dietary and lifestyle correlates of passive smoking in Hong Kong, Japan, Sweden, and the U.S.A.," Soc Sci Med 1997; 45: 159-69, a review of existing studies suggesting that wives of smokers ate more fried foods and less fruit, tended to have other less healthy behaviors similar to that of smokers, indicating that smoking is associated with social class and education, which should be taken into account in describing epidemiologic patterns. However, the point about confounding variables is reversible: People who smoke now more often come from lower socio-economic classes because the better-off have quit, or don’t begin, in larger proportions, and cigarette marketing is now directed toward the former. Fruits and vegetables have little to do with the matter.]

Professor Ueberla to do a meta-analysis of ETS studies if Koenig can find the funds.

# 4 March 1993, minutes, Reif to Pages and Kassman, "Meeting of the WPA," PM 2501004025 - 4027.

The assessment made by the "German dioxin pope", Prof. Neubert, was very clear. He said that there are better ways to spend DEM 100,000 than to make a study of the dioxin content of human blood fat [sic] due to smoking. [N.B. See appendix for document annotations on Prof. Neubert and his decade of continuous support by RJR for minor studies showing benzo(a) pyrene crosses the mouse placenta into the fetus.]

* 9 March 1993, telex, Andrade to Beecken, "Research involving human subjects," PM 2501139392.

Reflects worry by Charles Wall that VERUM will be funding ETS research involving humans, along the line of Magnussen’s work. How to manage this?

# 29 March 1993, memo from Lutz Mueller to Carl Ehmann (RJR’s new head of RJR R&D in Winston-Salem), "Meeting with Dr. Adlkofer, Head of the Scientific Department of the German Verband der Cigarettenindustrie." RJR 508304190 - 4190

Introduces Verband and Adlkofer to Ehmann. A bit of smoothing of the past history.

RJR has a good record of cooperation with the Verband’s scientific Department.... Dr. Adlkofer exerts a very strong influence on the scientific activities of the Verband and contributes a lot to the Verband’s scientific reputation. RJR’s relationship with him is quite active and sometimes a little wild. While we are not always happy with his workstyle, we as RJR are certainly in agreement with major parts of his philosophy.

# 22 April 1993, telex, PM Corporate Services to Rothmans Basildon, PM 2501193735.

Indicates that the 21-24 1994 Montreal conference on "The Effects of Nicotine on Biological Systems: International Symposium on Nicotine," will be funded in equal amounts by VERUM and by Rothmans (total $113 thousand). PM 2501193733 tells that the International Advisory Committee is headed by Adlkofer, along with Klaus Thurau, Neil Benowitz, among others. The preliminary program (PM 2029200660 - 0663) indicates a generally upbeat view of nicotine as a drug, including a presentation by RJR’s John Robinson called "Nicotine is not Addictive." Two papers by R. West (UK) and Jack Henningfield are tentatively scheduled, "Nicotine is not Addictive." McGill’s Paul B.S. Clark, Pharmacology and Therapeutics, is host of the conference and helped line up Rothmans (letter to Neil Sinclair, Rothmans Principal Scientist,

# 31 March 1993, PM 2028455443 - 5445) as funder. "For the first time at any nicotine conference, the therapeutic benefits of nicotine and nicotinic drugs will be highlighted." The conference participants and program may be found at # PM 2501193733, -3742, 2029200660 - 0663.

# 24 April 1993, minutes, Reif to Pages and Kassman, "Meeting of the WPA," PM 2028392489 - 2493.

At low ETS levels (4-6 ppm) low amounts of dioxin found in ETS, 0.15 picograms/mg, "the contribution of ETS to the daily human dioxin burden is next to nothing." The official founding session of the foundation VERUM was on 19 March 1993.

Adlkofer said that in the future all his reports will be published through the new foundation "VERUM" where the editorial committee will by definition not have any access nor right of release. König seemed to be a bit puzled by this and hastened to remark that though a scientist were free to utter his opinion he remained a member of a group – in this case our industry – and had to promote or at least not to damage this industry. However, he added, that he was fully convinced that Adlkofer has always taken care of this. [N.B. König, head of the VdC Administration and Adlkofer’s superior, here gives an accurate view of the role of science in the service of the tobacco industry.]

# 10 May 1993, memo, Helmut Reif (PM/Neuchatel) to Andrade, PM 2501193725.

PM USA generally indifferent to the Montreal Conference. Reif worried about any symposium on nicotine. "Klus of ATW [Austria Tabakwerke] says, if we cannot even speak about nicotine, what is then left?"

* 21 May 1993, memo, Pages to long distribution list, "IARC Study of ETS and Lung Cancer," PM 2029041843.

An alert to the impending study release, some material of which was leaked to Covington & Burling in London.

I would like all those who receive a copy of this memo to use whatever internal and external resources they may have or may know about to help us get more information on the IARC study as quickly as possible. I have already alerted Helmut Reif that I would like him to pursue the inquiry through his contacts at the VdC and also for him to ask Mr. Marcovitch to think about his potential contacts in France and Switzerland. [N.B. Iancou Marcovitch was with PM’s cigarette factory FTR in Neuchatel, Switzerland.]

# 24 May 1993, telex, Reiman to Walter Thoma, "Germany – Research funded by VdC and ‘Verum Foundation,’" PM 2501188620.

Asks for PM Europe assistance to let Andrade do a complete review of research sponsored by the German Industry. "I should mention that the German Industry apparently has been funding certain types of nicotine-related research in which, it is the corporate view, we should not be involved."

# 27 May 1993, memo, Thoma to Paul Hendrys (PM Neuchatel, on VdC Board), "Germany - VERUM Foundation (VDC), PM 2501188633.

You are aware of the fact that the Corporation and specifically GCB [Geoffrey C. Bible, CEO] continues to be sensitive about research projects.... By copy of this note to Andy [Andrade], I am asking him...to visit with you...in order to thoroughly review recent past, present and planned research projects.

# 29 May 1993, minutes, Reif to Pages, Kassman, and Anthony Andrade, "Meeting of the WPA, PM 2501004033 - 4038.

Dioxin task force asked to study and compare sources of dioxin other than tobacco ETS. A study of smoking and wrinkling to be undertaken by Prof. Vogt who is cautioned to take into account confounding factors like suntan, lifestyle, body weight, social context. "Therefore, for practical reasons, the study was put on hold for the time being." Scherer’s passive smoking study measured PAH, CO, nicotine, benzene in non-smokers exposed in an unventilated room to ETS. While passive smoking risk of lung cancer in a non-smoker is 4.5% that of a smoker, the biochemical measures range from 0-1.5% of what smokers take in. [N.B. Of course, this entirely overlooks duration and incremental dosages as DNA adducts form.] On low ignition potential cigarettes (i.e., fire-safe), "As this theme is extremely important on the long run but not urgent for the European context it was felt that an unrestricted discussion time would be needed and therefore the topic was left for the next session."

# 21 June 1993, telex exchanges, Richard Carchman, Helmut Reif, Anthony Andrade (Philip Morris counsel), PM 2029198728 - 729 (and two copies with nos. 2029198730 - 733).

Adlkofer was putting together a conference on nicotine in Montreal. He asks for help in recruiting speakers, such as Neal Benowitz (who in 1983 published in the New England Journal of Medicine the first peer-reviewed scientific article on smoker compensation). Reif notes,

He asked me as well if we would be against an inclusion of PREMIER [a non-burning nicotine delivery device]. I said that I will pass on the question to my colleagues. As long as PREMIER was not presented as the ‘safer’ alternative to the other products, I do not see principal problems. For me, PREMIER was more of a gadget for pharmaceutical delivery. However, as such, very much prone to a supervision by the FDA.

[N.B. RJR 511477664 - 7669 tells the story of baboons being trained to smoke Premier cigarettes; since this device drew harder than usual cigarettes the experimenters tested whether there was "drug delivery" by lacing the experimental cigarettes with crack cocaine. Little was absorbed by the monkeys. One interpretation was that "Premier really does not serve as a drug delivery device."]

* 23 June 1993, memo, R. Walk to S. Parrish, in tabular form, "Current biological research ETS," with the document disclosure title (4B index) indicating "...regarding funding of Center for Indoor Air Research." PM 2029197387 - 7391.

VdC listed with six projects in humans, from 1989 to 1992, "biological effects in nonsmokers experimentally exposed to ETS," as well as VdC-supported research on hamsters, and VdC-supported research on asthmatics. This document was prepared for Joint Defense Employee, and suggests funding coming through the industry-front organization CIAR, Center for Indoor Air Research.

# 24 June 1993, hand-written notes, Helmut Reif, PM 2501004013 - 4017.

These seem to be ruminations and aide-memoire on a number of topics: 1) Dioxin is found by non-industry scientist in tobacco smokers’ hair; Reif opposes doing much research on the matter especially in relation to ETS. 2) Complaints about Adlkofer not sharing VERUM or VdC information. "He could be looking for a safe haven for stating his views. Adlkofer believes the public would believe the industry if he said smoking causes disease in smokers but ETS is a hoax." Adlkofer apparently in powerful positions both at VdC and VERUM: "Is the Munich lab property of the VdC or Dr. Adlkofer’s privately owned lab?" "Adlkofer thinks smoking is the main cause of wrinkles."

# 9 July 1993, hand-written notes, Helmut Reif and Ulrich Beecken (same handwriting as above), PM 2501004003 - 4010.

More complaints about VERUM and lack of industry control. Another wrinkles study reported, 80% of women smokers have more wrinkles than non-smokers. "Adlkofer’s 3 areas of control: 1. His lab in Munich 2. Secretary at Verum Foundation 3. Scientific Director of VdC."

Writer asks many questions about how to control VdC research and funding. Mention of a benzene study in smokers’ body fluids in Adlkofer’s laboratory. Mentions a study looking at DNA adducts in placentas of smoking women who delivered. Endogenous nitrosamine study stalled.

Aircraft air quality study planned.

# 25 August 1993, minutes, Reif to Pages, Kassman, "Meeting of the WPA," PM 2028455187 - 5194.

Discussion of new company products, CORESTA task forces on tobacco factory emissions and waste tobacco dust. Measurements of ETS dioxin under "realistic conditions" (ERGO lab’s offices) show it to be four times ambient outside air (0.08 I-TEQ/cbm vs. 0.02-0.03), which the minutes record as, "The uptake of dioxins by passive smoking is of the same order than than by outdoor air." Uptake from food is much greater. "The TF [task force] does not see any necessity of continuing the experimental work and could see a possibility for the PR treatment of this topic in a paper....

Magnussen is asked to comment on a paper by Chilmonczyk on the chronic effects of ETS on asthmatic children, and admits that his own experiments were on acute (one hour) exposure, and that "I have never denied that there are chronic effects.... It is clear that asthmatic children which are exposed to ETS have to see their doctors more often."

Wynder’s study on Japan and USA lung cancer incidence was removed to the Forschungsrat for funding. WPA will try to disprove Hecht’s new work showing more tobacco-specific nitroasmines in smokers’ urine than could be accounted for by transfer from smoke, that is, they have been endogenously produced from nicotine.

# 3 September 1993, memo, Andrade to Wall, "German Research," PM 2023222600 - 2604.

Apparently as a result of his investigations, Andrade now describes a procedure to review research proposals brought by Adlkofer to the VdC WPA (Reif and Beecken are now the representatives). The procedure sounds remarkably like what had gone on in the previous 15 years, including formation of task forces (here called "study groups") for "controversial or ill-advised proposals." Of course, VERUM research is out of PM’s hands; Andrade can only hope to keep up with what is going on. The list of current projects being funded by VdC is as follows:

Evaluation of polychlorinated dioxins and furans in ETS; dioxin research; pilot project on the influence of radon in development of lung cancer; psychosocial use of smoking; health lifestyles in families; lung cancer in Saarland (case-control pilot study); delayed response of respiratory response after passive smoking; prospective study of smoking and non-smoking pregnant women; determination of modified DNA bases (adduct study); study of exposure to benzene, ethylene and ethyleneoxide in the population at large; metaanalysis on passive smoking (Dr. Ueberla); lung cancer, diet and genetic predisposition (Dr. Rylander).

# 3 September 1993, telex, Andrade to Beecken, "Research involving human subjects," PM 2501004082.

Chuck Wall called to ask me if we were comfortable that no ETS research involving human exposure was being supported by the industry in Germany. I told him that I was familiar with the research projects being funded directly by the VDC and that no such research was being supported.... Chuck then asked if the VERUM Foundation is funding ETS research involving human exposures. I told him I could not answer definitively but I was not aware of any such research. We discussed the independent status of VERUM and the inherent difficulties of following their independent funding decisions. It is clear that we need to communicate our views on ETS research involving human exposure to appropriate representatives of VERUM. Also, it is important that we are able to follow the research program funded by VERUM and learn what research they have decided to fund after such grants have been made. [N.B. This an alarming matter for the lawyers. See 23 June 1993. At no time is "informed consent" ever discussed in any of the meeting notes.]

* 6 September 1993, telex, Anthony Andrade (PM in-house counsel) to Charles Wall,

"Subject: VdC sponsored research." PM 2501003992.

Verband members agreed not to fund any human research without prior approval of all members, and no human exposure work ever involving children or any other "susceptible" group. "Finally, if any human exposure research is to be funded in the future it must employ only exposure levels that replicate ‘real life conditions’." [N.B. See entry for 28 May 1984, where the Austria Tabak company did just that research, finding elevations in room air chemicals from smokers, and elevations in blood carbon monoxide in smokers and non-smokers in the room.]

# 1 October 1993, minutes, Reif to Pages, Kassman, "Meeting of the WPA," PM 2028344012 - 4017.

Planning of a new ETS study, "the most comprehensive ever done," according to Adlkofer. "There was no in-depth discussion on some of the controversial points...." Discussion of impending ban on smoking on Lufthansa flights:

Adlkofer mentioned his recent contacts with Ciba-Geigy.... Ciba-Geigy wants to market their patches for situations where smoking is prohibited (aircraft). Asked bluntly if they believed in an effect, they said no. However, since their [sic] was a market potential, they will advertise for it.

# 5 October 1993, memo, Reif to Andrade, PM 25010003918.

Asks for advice regarding to the planned VdC ETS study (see above) involving human subjects (smokers and non smokers).

* 19 October 1993, telex, Andrade to Reif, "ETS experiments involving human exposure, " PM 2501003917.

Asks for clear understanding of above ETS proposal, if it would add any scientific information and if it had a sound design.

I understand that while the company policy does not necessarily prohibit all ETS experiments involving consenting adults, it is obviously necessary to be sensitive to the human exposure issue in evaluating the scientific merit of individual research proposals.
[N.B. Even by this late date, 1993, it is obvious that "company policy" had not considered a human subjects review board, standard in all reputable research institutions for many years.]

# 13 November 1993, minutes, Reif to Carchman, Kassman, "Meeting of the WPA," PM 2028389274 - 9279.

Considerable attention to political matters (EEC, Coresta -- "sidestream smoke will not be discussed anymore" -- German Law). At an Austria Tabak symposium Ernst Wynder said the risk of passive smoking is not proven, and product modifications led to a reduction in lung cancer. [N.B. Given Wynder and his colleagues wrote on the change in histopatholgy of lung cancer, one wonders if he really said the latter. See Hoffman D, et al. "The biological significance of tobacco-specific N-nitrosamines: smoking and adenocarcinoma of the lung," Critical Reviews in Toxicology 1996; 26: 199-211. The hypothesis framed here is that smokers drag more deeply on low-nicotine cigarettes, exposing more peripheral lung tissue, resulting in more adenocarcinomas than squamous cell carcinomas.]

On Hecht’s study in the New England Journal of Medicine on NNAL in non-smokers exposed to passive smoke: "Wynder reportedly opposed the publication but could not stop it." [N.B. My conversation with Hecht August 5, 1999: he had no knowledge if this occurred.] VdC will try replicate study. (An attack on this study was carried forward by Überla in the New England Journal of Medicine, successfully parried by Hecht.) A study of oral pre-loading with nicotine did not diminish cigarette intake, an argument against nicotine gum.

# 30 November 1993, memo, Winokur (PM counsel) to Beecken, "STOA environment and health project," PM 2501346759.

Asks Beecken to obtain VdC help to rebut allegations on ETS by the Trichopoulos report given in the 12 November 1993 workshop of the European Parliament Scientific Advisory Group (STOA). The Member of Parliament, Ms. Schleicher intends to put forward a strong proposal limiting ETS in public. The rebuttal is to assist the CECCM (Confederation of European community Cigarette Manufacturers), and to be coordinated by Dembach of RJR. PM and BAT will submit a parallel rebuttal drafted by Covington & Burling.

# 14 January 1994, list, "Research Projects granted by VERUM Foundation," unsigned, PM 2028359966 - 9969.

1) Nicotine brain receptors; 2) nicotine effect on ion channels and intracellular calcium; 3) biomonitoring of nitrosamines; 4) effect of nicotine on fibroblast growth factor in rats with Parkinsonism; 5) nicotine interaction with inflammatory mediators and artery wall; 6) aromatic amines in mainstream and sidestream smoke (Grimmer); 7) nicotine related changes in the EEG and behavior of rats; 8) nicotine effect on blood pressure; 9) antioxidants protecting against damage to lungs by smoke; 10) nicotine effect of neuroendocrine cells of the lung; 11) molecular epidemiology of cancer; 12) nicotine, carbon monoxide, nitrogen oxide effect on coronary circulation in oxygen-deprived heart muscle; 13-15) fat metabolism, 16) nicotine effect on neuroimmunology of lung; 17) one study on growth of brain cells. [N.B. VERUM clearly a nicotine research foundation, with some elements of "safer cigarette" basic research, and just a little on metabolism.]

# 27 January 1994, minutes, Reif to Carchman, Kassman, "Meeting of the WPA," PM 2501003892 - 3894.

Responses to regulations, response to Hecht. ERGO did not find dioxins in kitchen exhaust, did find it in Danish chimney smoke from an open fireplace.

# 18 March 1994, minutes, Reif to Carchman, Kassman, "Meeting of the WPA," PM 2028343996 - 4001.

Many studies mentioned to counteract Hecht’s findings of nitrosamines in non-smokers exposed to ETS. Most labeled, "postponed" or "canceled" (the latter referring to a direct replication of Hecht’s study).

ERGO’s dioxin results summarized. In picogram/cbm I-TEQ, outdoor air 0.02/0.03, ETS of 10 ppm room CO 0.19/0.23, ERGO offices 0.08, Danish vacation house chimney before open fire 0.07, after open fire 0.49/0/31, road traffic 0.08, candlelight concentrated sidestream 0.9/1.6/0.9.

The results show that the ETS contribution can be neglected toxicologically but is NOT zero.... Even active smokers get only 3% of their daily intake from smoking, 97% originate from the daily diet. The intervention threshold for Hamburg kindergartens was set to 0.5 pg/cbm I-TEQ which is five times the concentration found in ETS-laden office air. [N.B. Was the office air ventilated? Should one especially worry about eating in a candle-lit restaurant with an open fireplace where smoking is permitted?]

# 25 March 1994 and 4 May 1994, tables, "VdC Research Program of TSNAs [tobacco-specific nitrosamines]," no author, RJR 508725671 - 5672, and RJR 514890720 - 0721.

RJR views metabolic studies as necessary, passive smoking studies as not. A study that suggested that nicotine deactivates nitrosamines (50% reduction in urinary excretion) should be published immediately.

# 3 May 1994, minutes, Reif to Carchman, Kassman, "Meeting of the WPA," PM 2028388912 - 8915.

NITROSAMINE RESEARCH The analysis of the urine samples by Dr. Klus (leftover from the EXPO 92 study) showed an unexpected high amount of NNAL, which was in reasonable agreement with the Hecht, AHF, results. However, at the EXPO 92 study, no measurement of NNK room concentration has been made. A simulation of a similar ETS concentration rendered only 10 ng/m³ NNK (by far too low to explain the amounts found in the urine). Could be either (a) a mistake in the room air determination, or (b) an indication for endogenous nitrosation.

SYMPOSIA SPONSORED BY THE INDUSTRY As usual (one is tempted to say), Adlkofer and König criticised the symposia (such as IAI, and the like), organised by the Industry. According to them, these low-level symposia have triggered the recent article by Lisa Bero on the industry’s involvement. {N.B. Pot and Kettle: Adlkofer’s VERUM and Rothmans supported the McGill international nicotine conference.]

# 2 June 1995, letter from Reif to Richard Carchman, 2050762683 - 2684.

Adlkofer’s successor at VdC is Professor Moesges. "The whole selection process went like a secret service action. Hendrys had not even informed Beecken." Dioxin seems to be a residue on tobacco leaf, in small amounts. Wynder’s money for the Japanese study from PM has not yet arrived.

# 2 July 1994, minutes, Reif to Carchman, Kassman, "Meeting of the WPA," PM 2028343992 - 3995.

DISCUSSION OF THE GERMAN REACTIONS ON THE RECENT FONTHAM STUDY There is unanimous opinion that a lot of confounders have been avoided (or taken account of) in this study. However, the raw data are not publicly available which means that one has to believe that Fontham has corrected for all confounders. Moreover, it is complicated to find in California smokers of all social levels, the lower ones being over represented.

NITROSAMINE RESEARCH Studies [unspecified] have shown that the NNAL content of ETS exposed smokers is significantly increased (20-30 ng/ml of 24h urine, after exposure to ca. 20 ppm CO, 3,500 ug/cbm TPM). Active smokers show up to 300 ng/ml. These results prove the Hecht paper. The next step will be to check the NNK content of the ETS atmosphere. There is evidence that the results until today have relied only on the NNK contained in the particle phase whereas the gas phase was never looked at. Gas phase inhalation during normal breathing could result in an increased intake of gaseous ETS compounds

* 4 July 1994, telex, Reiman to Beecken, "VdC," PM 2501003145.

I understand from Walter Thoma that the minutes of the March 22 VdC meeting contains a number of references to nicotine, including one to the effect that "nicotine is...the reason why the consumer smokes." This statement does not seem to be attributed, but it is exactly the kind of misleading and inaccurate characterization that is causing such a fuss in the United States. I think everyone is expecting you to make sure the VdC stays on track, and does not get itself embroiled in these types of issues, particularly when they involve areas about which the participants have no particular expertise. Could you please try to be a little more vigilant on this?

# 8 July 1994, letter, A.R. Tricker (VdC) to R.A. Walk (CRC Contract Research Center, Brussels), PM 2029050166.

The Verum Foundation is currently co financing part of the European Prospective Investigation into Cancer and Nutrition, a multi-centre prospective cohort study in which more than 5400,000 subjects will be questioned on nutritional status and daily dietary intake. The subjects will be followed up to investigate the incidence and mortality from cancer in relation to epidemiological data and biomarkers in the blood. Two centers have been selected in Germany: Potsdam (coordinated by Deutschen Institut fur Ernahrungsforschung...and Heidelberg (DKFZ).

* 21 July 1994, Letter, from E. Anderson (PM consultant) to Levine (PM counsel), PM 2048712246 - 2555.

Outside consultant reporting on the McGill symposium on nicotine, listing participants. Under the category of "Persons who generally support the ideas that smoking is not necessarily harmful or addictive, or that it should not be strictly regulated," is Adlkofer, one of the meeting’s organizers. "He gave one of the three opening talks and believes that nicotine is not harmful, in that it does not cause cancer or cardiovascular disease...." Though against smoking, P.B.S. Clarke was helpful in showing that nicotine is not addictive but that smoking behaviorally, not pharmacologically reinforcing. Robert West and Jack Henningfield gave the only unqualified talks on the addictiveness of nicotine. RJR’s John Robinson gave a stout defense of the notion that nicotine was like caffeine... and television watching... and video games, sex, gambling, jogging.... But not addicting.

The consultant also listed themes and ideas that could be used by industry in defense of nicotine as a good substance, not addicting, and helpful in some diseases. And of the findings that find nicotine addictive, all can explained away or shown to be insufficiently supported or impugned.

People with pyschiatric disorders have a much greater tendency to smoke. There is research to suggest that as more people without psychiatric disorders quit smoking, the population of smokers who will remain will be dominated by people who are schizophrenic, depressed, using other drugs, or are incarcerated as criminals.... It is not in our client’s best interest to have their product so strongly associated with these types of people. [N.B. The irony is unintentional.]

# 18 September 1994, memo by Reif to R. Carchman, "Comments to individual items of the above program...in order to find a compromise with the opinion expressed by Ulrich Beecken and Paul Hendrys," PM 2050754983 - 4985.

Wants VdC to have a Scientific Communicator, someone who maintains academic ties, collegial and mentoring. The question of Adlkofer’s successor is behind this: Lutz Mueller of RJR insists on no new "Super Daddy" like Adlkofer.

# 14 October 1995, newspaper article (translation) from Der Tagesspiegel, "How the tobacco lobby influences Federal authorities," PM 2050740131 - 0132.

A conference on passive smoking at the Robert-Koch-Institute in Berlin (an official agency of the Federal Health Ministry) was funded in great part by VERUM, which managed to hide the association with help from the department head of the Ministry Department of Epidemiology, Cancer, CVD, and Natural Medicine. The meeting was organized by Hans Hoffmeister, director of the "High Commission" successor to the Federal Health authority. The hand-picked speakers concluded that a causal relationship between passive smoking and lung cancer is unproved. The Parliamentary State Secretary in the Health Ministry opened the conference.

# 1 February 1996, television transcript (translation) of the program Kontraste: "Report on Verum Foundation," PM 2063600437 - 0443.

Reveals further details of the conference, with excuses given by Hans Hoffmeister, head of the Robert Koch Institute: "In this case we were grateful for what we have received by VERUM’s offers of support, and we have accepted it as such. In that connection I do not see anything which one should not do."

Nonetheless, VERUM removed its name from sponsorship because two other symposia were canceled when it was learned that VERUM was sponsoring. The main result of the conference was to cast doubt on the role of passive smoking in inducing lung cancer, and on the studies that up to now have demonstrated that role.

# 15 July 1997, memo, Reif to Gerry Nixon, SRRC PM/Richmond, "Minutes of the VdC/WPA meeting of June 13, 1997," PM 2060547076.

Mentions plan to see if genetically modified tobacco is used in the top 20 German brands.

APPENDIX

A chronology of documents showing research support by RJR to Prof. Dieter Neuberg. The basic research was to determine if toxic components of cigarette smoke passed from a pregnant woman or animal to the fetus.

* 5 October 1978, RJR 503247183. Neubert first comes to RJR Chief Scientist Frank Colby’s attention.

* September 1978, RJR 500950214. Professor Dieter Neubert is an eminent pharmacologist with institute for toxicology and embryonal pharmacology of the Free University of Berlin. Has a bank of aborted fetuses, wants to study benzo(a)pyrene hydroxylase – a potent tobacco-related carcinogen – in fetuses of smokers and non-smokers. Colby "investigates" him via literature search and finds he’s made no adverse statements on smoking.

* 29 November 1978, RJR 500884388. Colby finds Neubert indeed has made comments on tobacco of a negative nature, but believes he is an outstanding scientist.

* 23 February 1979, RJR 500871970-1971. Colby recommends $26,000 for Neubert., notes he wrote a general review paper with a traditional anti-smoking view.

* 26 March 1979 RJR 500950202. Colby anticipates a five-year project.

* 5 September 1979, RJR 500950161- 0164. Colby budgets $47,000 for 1980 continuation of 1979 projects, $48,000 for 1981, $47,00 for 1982. Two projects - one on humans, one in animals.

* 5 September 1979, RJR 500877370. Colby notes that with change in abortion methods from D&C to chemical abortion, measurements of benzo(a)pyrene will not be possible.

* 12 June 1980, RJR 500949814. Colby notes that human project may not get done at all.

* 4 August 1981, RJR 500950067 - 0070, Oskar Stuhl (RJR Germany) describes preliminary results: mouse fetuses exposed to cigarette smoke in utero develop enzymes to counteract benzo(a)pyrene. It is essentially what gets published in 1988. Neubert wants more money to repeat the study in marmosets.

* 18 November 1981, RJR 500534360. DM 150,000 budgeted for Neubert.

* 8 November 1982, RJR 50534256. Stuhl reports that the fetal mouse study being prepared for publication.

*.18 January 1983, RJR 500528904. Colby recommends another $28,000 for 1983 and also for 1984 and 1985 to study rats and marmosets. Neubert off to California for six months sabbatical.

* 20 June 1983, RJR 503248613, Neubert to start with marmosets.

* 24 November 1983, RJR 504642440. Stuhl says paper on rats will be ready in 1985.

* 7 November 1985, RJR 505743310. RJR toxicologist A.W. Hayes says Neubert will start on marmoset work. In RJR 505743315 Hayes says Neubert is very slow in his work possibly because of insufficient funding, and as money comes to Neubert directly, not through the university, he doesn’t feel the pressure they might as from their university research.

* 13 January 1986, RJR 515215887. Stuhl budgets for DM 74.1 (000) DM in 1985 and 88.92 (000) in 1986. Unexpected experimental difficulties caused delays.

* 26 November 1986, RJR 506811935- 1937. Stuhl again summarizes results of the research.

* 15 May 1987, RJR 506227635. R.I. Suber speaks of minor delays due to RJR delay in funding, study to end by 1987; summarizes induction study as finally published.

No further documents. Marmosets not done. No paper on rats.

[N.B. In two papers by Neubert in Archives of Toxicology evidence was found for the passage of benzo(a)pyrene (BaP) in fetal mice livers and other tissues by maternal mouse pretreatment with BaP. See Neubert and Tapken, "Prenatal induction of benzo(a)pyrene hydroxylases in mice," Archives of Toxicology 1988; 62:192-9, and Neubert and Tapken, "Transfer of benzo(a)pyrene into mouse embryos and fetuses," Archives of Toxicology 1988; 62: 236-9.]

No other papers found on the topic by Neubert, but lots of his other work on thalidomide and other chemicals and drugs that cross placenta of animals.