SHAMEFUL SCIENCE:

Supplement I

The continuing saga of suppression of research on smoking and health by the

Tobacco Industry

Norbert Hirschhorn, MD

Consultant to the World Health Organization

5 April 2000

Introduction

Last September I posted on Globalink annotations of over 500 documents from the Tobacco Industry’s formerly secret documents showing the way the transnational companies and the Association of Cigarette Industries of Germany (the "Verband") struggled 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. In the introduction to the 130-page document called "Shameful Science. Three Decades of the Tobacco Industry’s Hidden Research on Smoking and Health," I summarized the findings as follows:

1. 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.

2. 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.

3. 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.

New documents have now come on line on the Philip Morris and RJR websites, spanning the period from 1992 to late 1998; in addition, older documents have come to light, and reveal the following:

The biologic evidence for the ill-effects of passive smoking could no longer be denied; in fact, Verband scientists reproduced the key findings. Even so, the major transnational companies continued to try to suppress the information and the very research itself, adamantly and consistently over the decades. The Verband itself continued in its secretive ways, always protective of the business of selling cigarettes, even as research it supported was suspected to be false.

The Verband’s influence at high government and academic levels is again demonstrated, and its newest research interest, serving the transnational firms, is in genetically modified tobacco.

Earliest intimation that PM knew of pre-cancerous changes due to passive smoking: “INBIFO: The metaplasia findings in the tracheas of smoked mice were confirmed by Professor R. Leuchtenberger.... INBIFO knows already that some experiments will have to be devised with hamsters, in order to know the best exposure conditions in comparison with rats.” Professor Dontenwill is apparently beginning such work and writer alludes to “the difficulty Dr, Weber [research director of the Verband] has to influence Prof. Dontenwill’s research program.”

21 October 1970, memo from H[elmut] Wakeham (PM VP R&D) to Hugh Cullman (PM CEO), “Participation in the German Cigaret [sic] Association Program,” PM 1000302189.

Philip Morris Germany joins the Verband der Cigarettenindustrie. It is clear that research looking at the untoward effects of tobacco was not being done in the USA, but as it was carried on in Germany, PM needed to learn about it “first-hand.” Max Hausermann of PM/Europe designated as the representative. The “Forschungsinstitut” headed by Dr. Dontenwill quickly gave PM a major headache (see 17 November and 6 December 1972 entries).

We believe this is an excellent opportunity to get inside information with regard to the cooperative technical activities going on in the German cigaret industry, as well as the opportunity to obtain first-hand or direct information about the results of the testing program at the Forschungsinstitut, where the bioassay studies are being made under the directorship of Dr. Dontenwill.

10 March 1971, memo from Max Hausermann to S. Gunnarsson (PM executive), “Application of PHILIP MORRIS GERMANY for membership to the Scientific Advisory Boards of the German Cigarette Manufacturers’ Association and of the Industry Institute,” PM 1000301234 - 1235.

PM’s membership in the VdC did not automatically confer membership on the research arms; in fact, as Hausermann points out here, PM had yet to be invited and Hausermann was lobbying with the Director of VdC’s research program, Dr. Weber, for such an invitation in order “to have true access to the results which are produced by the German Institute.” But Hausermann warns against letting PM’s membership on the Scientific Board be used as “a pressure argument” for “marketing considerations.... Since general considerations and specific marketing interests are contradictory in this field, I would suggest that we discuss the matter with Mr. Holtzman [PM chief counsel] before a formal application is submitted to the VdC.”

17 November 1972, memo from Alexander Holtzman (Philip Morris lawyer) to J.F. Cullman 3rd (PM Chairman of the Board), "Forthcoming Scientific Report by German Cigarette Industry," PM 1002601095 - 1097 (from secret document website <www.tobaccodocuments.org>).

Holtzman discusses the upcoming 21 November press conference of Professor Walter Dontenwill, then Director of the Cigarette Industry (Verband) Research Institute, in which he presents data on producing laryngeal cancers in hamsters by inhalation, and mouse skin cancers by painting with cigarette condensate ("tar").

Readers of "Shameful Science," the first installment, will recall that Professor Dontenwill was pensioned off and his laboratory closed in the summer of 1975, in all likelihood because he found cancer due to inhalation of cigarette smoke in an experimental animal, something the industry continuously alleged had never been shown. [NB. See the second annotation dated 23 July 1992, and the subsequent chronological annotations from 18 July 1975, 21 November 1977, 12 August, 8 September and 28 October 1981, 13 April 1982, 1 October 1991.] In this memorandum Holtzman paints a very positive picture that Dontenwill will provide optimistic evidence that such advances as cellulose acetate filters seemed to be protective, and that the hamsters did not suffer heart disease or emphysema or lung cancer. All this would be expected to promote the idea that American and German cigarettes were already "safer."

The purpose of this [press conference] is to tell the German public and government that the German cigarette manufacturers have in fact and been marketing a "safer cigarette;" ...and that the only refinements of these features are necessary to further reduce the risk of cigarette smoking.... The general conclusion is that the studies prove that the biological activity of cigarette smoke can be influenced through modification of the product and that ways and means of reducing the risk of cigarette smoking are taking form.... If the U.S. industry should have an opportunity to comment on this development through a statement to the press, I would recommend that our reaction be expressed in a way that would take full advantage of the favorable conclusions [emphasis in original].

6 December 1972, telex/memo, Ronald Thomson (a PM tobacco scientist, see PM 2023561530 - 1533) to Chairman of the Cigarette Manufacturer’s Association (Germany), CC: All Members, PM 1003717894 - 7895.

Earlier drafts of this telex may be found at <www.tobaccodocuments.org> PM 1005056296 - 6298, 1 December 1972, and 1002600627 - 0629, 6 December 1972.

Something went radically wrong at the press conference, at least as far as Philip Morris was concerned. Holtzman and Hugh Cullman (later to be Chairman of the Board) drafted this angry protest to be sent out by Thomson to the Verband, and serves to explain why Dontenwill and his laboratory were eventually closed down. The telex/memo sent to Thomson for forwarding is quoted in its entirety here.

Gentlemen: As a member of the cigarette manufacturers’ association, we wish to protest formally the remarks made by Professor W. Dontenwill in the name of the association at his press conference in Hamburg on November 21, 1972. Our analysis of the results of his study indicates the conclusions stated by Professor Dontenwill are not necessarily correct interpretations of the results of his own experiments and in some respects do not accord with the findings reported by other scientists in their investigations of the effects of cigarette smoke on the respiratory tissues of experimental animals. It was both gratuitous and misleading for Professor Dontenwill to imply that, because he had described his findings at the National Cancer Institute, in Washington, D.C., U.S.A., the week before his press conference, these findings had thereby gained scientific review and endorsement. According to observers, Professor Dontenwill’s summary remarks to a closed small group meeting at the National Cancer Institute were received with some skepticism, and Professor Dontenwill quite deliberately evaded all questions put to him concerning the data he presented. Professor Dontenwill declined to distribute or leave copies of his report with the participants. [NB. In fact, his findings were published in a prestigious, peer-reviewed journal: W. Dontenwill, et al. Journal of the National Cancer Institute 1973, vol. 51, 1781-1832.] In our judgement it is both inappropriate and misleading for the entire German Cigarette Industry to be associated with Professor Dontenwill’s effort to make a scientific cause celebre out of studies which, at best, lead to a variety of interpretations. The impropriety of this incident is compounded by the fact that Dr. Max Hauesermann [sic], our representative on the scientific committee which oversees the conduct of industry’s research program, was peremptorily informed that he could not review, consider, or even be permitted to attend his press conference. This same condition may have been imposed against the other members. Furthermore, we think that it should be recorded that while certain members of the German Cigarette Industry acquiesced in the issuance of Professor Dontenwill’s remarks, our opinion was not sought and we did not acquiesce. We take strong exception to Professor Dontenwill’s expounding his personal theories in the name of the entire cigarette industry without our concurrence, and we disagree strongly with many of the opinions he expressed, which are not supported by experimental findings. We are deeply disappointed that we were not permitted to review, consider and comment on the content and presentation of Dr. Dontenwill’s press statement. Further, we strongly feel that any statement of significance made in the name of the Cigarette Industry must be endorsed by all members. We, of course, remain enduringly committed to the development and marketing of improved cigarette products. Very truly yours,

Mr. Thompson [sic] – The foregoing was dictated by Hugh Cullman and Alexander Holtzman

24 January 1973, draft trip report from Sir Clifford Jarrett (BAT), Dr. G. Todd (BAT R&D), Dr. T. Osdene (PM Chief Scientist), Dr. R. Seligman (PM scientist) and Dr. Francis Roe (BAT consultant), Tobacco Research Council, PM 1000126126 - 6133.

Visit to several industry laboratories to ascertain what was being found with respect to cancer studies and possibility of a safer cigarette using synthetic tobacco (NSM), but with an eye to legal immunity, not health. With respect to the Verband:

Overall impression is that of very close cooperation and mutual confidence between the Verband and the scientific arm of the German Ministry of Health. Mutual confidence has been established so that the Ministry seeks advice from the Verband’s scientists (re: inventions) and participates in scientific conferences. In fact the Ministry’s toxicologist [handwritten: identities submitted to Ministry – they made up list which will be given to Verband... probable assist in writing law] will attend a forthcoming German industry session on pesticide residues so that the law can be framed around limits within which the German tobacco industry can live.... Synthetic tobacco is going to be tested by Dontenwill.... Products which do show lower biological assay from the Verband’s data probably can get German Health Ministry sanction as a "safer" cigarette. Once this has been obtained, the cigarette manufacturer using this material will have legal immunity in Germany.

17 July 1973, memo from Hausermann to Helmut Wakeham, PM VP R&D, “Germany: Industry Institute,” PM 100034636 - 4639.

Having already been burned by Dontenwill’s apostasy with respect to laryngeal tumors in passively smoked hamsters the “Institutsverein” (or General Assembly of Dontenwill’s cigarette industry research institute),

...the Assembly accepted -- very reluctantly -- a pilot experiment with mini-pigs to be conducted by Professor Dontenwill during the year to come (summer 1973 - summer 1974). Mr. Schlenker and the Association officers expressed their concern on this matter: What shall happen if cardiovascular diseases are experimentally produced in mini-pigs exposed to cigarette smoke? Professor Dontenwill argumented that he knows about serious university research already going on in this field, and that the cigarette industry should not stay [out]. What the Association fears is that if he does succeed in producing cardiovascular diseases in mini-pigs, he will not hesitate to publish the results. [Emphasis added]

[NB. Dontenwill had already published in 1973 data on the cardiovascular effects of passive smoking on hamsters, “The effect of long-term cigarette smoke exposure on the cardiovascular system of Syrian golden hamsters,” in the German journal Virchows Archiv A Pathol Pathol Anat 1973;361:147-62. We may speculate that perhaps the closure of the laboratory in 1975, nearly three years after the hamster experiments came about because he was finding similar results in the mini-pigs. No such publication appears in the literature. In 1980, BBC’s Panorama broadcast “A Dying Industry,” exposing tobacco company tactics. An associate of Dontenwill’s, testifying anonymously, said the 1975 closure was “like a flash of lightning.... We supposed that the Institute was closed because of the results we were getting from our experiments into arterio-sclerosis in the pig.” Transcript found at cdc.gov/tobacco/industrydocs, Guildford or Minnesota Select Set, B&W 680048944 - 8965, at -8950)]

3 September 1974, memo to file by Hausermann, “Meetings of the Scientific Advisory Boards of the German Industry Institute and the Forschungsstelle,” PM 1000012577 -2582.

Professor Dontenwill still holds out, but VdC tries a bureaucratic reshuffling of the Institute Board “to weaken Professor Dontenwill’s autonomy.”

5 November 1975, memo from Dr. Bruckner (head of VdC) to member firms, “Founding of a Smoking and Health Research Council,” PM 1003717837 - 7839.

The Council was promulgated in June 1975, at the same time that the cigarette industry laboratory was shut down, and clearly to regain control of what industry research should be about, while denying the health hazards publicly, engaging the quest for the “safer cigarette.”

In stating the purpose of the Research Council, we have been guided by the proposition that no causality between smoking and any concrete injury to human health has been proved. On the other hand, it is indisputable that both noted scientists and members of the public have been bringing up such a charge of hazardousness to health.... It must be the legitimate interest of every cigarette manufacturer, through support of research projects, to further the development of cigarettes that are not open to the charge of hazardousness to health.

16 December 1976, memo from Hausermann to S. Gunnarsson (PM executive), “German Research Council on Smoking and Health,” PM 1003717830 - 7833.

Professor Schmaehl of the German Cancer Research Center at Heidelberg appointed as Chairman. The idea for the Council came from BAT, Brinkmann and Reemstma. Schmaehl’s vision of the Council was one to propose research projects to VdC, with no industry scientists on the Council yet in close cooperation with them; and to seek the path “toward a less harmful cigarette.” Ernst Wynder to be a member of the Council because “He is considered as the originator of the ‘less harmful’ concept.”

23 January 1976, memo from Frank Colby (RJR scientist) to H.C. Roemer (RJR counsel), "Secret," RJR 500924628 (from www.tobaccodocuments.org).

Report of a meeting of German tobacco industry scientists and executives on the newly formed [post-Dontenwill] German Research Council on Smoking and Health.

Prof. Schmaehl then said that the continuing, often highly emotional, debates on smoking – and as he phrased it – "dangers to health", present a challenge to science and that research is needed to help find a solution. He stated that in view of his many years of experience he believes that the most effective contribution will be a scientifically based modification of the product in order to "decrease the health risks due to smoking."

2 June 1976, minutes, Hausermann to Gunnarsson, “VdC Meeting on the Research Council,” PM 1000122983 - 2985.

The main reason for closing the cigarette industry research institute headed by Dontenwill “reportedly was the fact that in matters of smoking and health, the Institute was the only ‘porte-parole’ of the Industry. Prof. Dontenwill’s uncooperative and authoritarian manner made it impossible for the VdC (and the Industry) to expose their views in these matters.”

Mid-1970s (from internal evidence), report by Frank Colby, RJR 500924982 - 5003 (also transmitted under B&W from EJ Jacob of Jacob, Medinger to JK Wells of B&W, 00007300560001 or 680252695 - 2716; all via www.tobaccodocuments.org)

A comprehensive and highly negative, even pejorative review of some two dozen German Tobacco Industry research projects dealing with finding and isolating toxic compounds from cigarettes. Some excerpts indicate the unyielding view, until last year, of the industry (not just Colby’s as other documents in "Shameful Science" show) that cigarettes are not harmful and no research should be done that even suggests that possibility.

RJR has always rejected the idea of developing a "safe" cigarette being based on an unfounded assumption, to wit, current cigarettes are unsafe. Instead, RJR’s position has always been, and still is, that cigarettes have not been scientifically established as disease producing in human smokers.... The main objection to these [angiotoxicology] projects is the fact that they will be done by Professor Schettler and his co-workers. Professor Schettler is a long-standing and out-spoken opponent of smoking and, therefore, any research undertaken by him would likely be tainted by his biased viewpoint.... This project is based on the unfounded premise that cigarette smoking has untoward health consequences on the human cardiovascular system, a premise not accepted by RJR.... Our objections to these [Ernst Wynder] projects are very strong. This series of projects does not deal with German products or German smokers. Rather it deals with a comparison of American tobacco products and their health consequences on American smokers by an American researcher who is avowedly anti-tobacco [NB. See first installment of "Shameful Science" for pioneer scientist Wynder’s close ties to the Verband.].... The financing of his research on American products by a tobacco interest, albeit a foreign one, places the American industry in a potentially embarrassing situation. It is possible to conceive, if not probable, that in future Congressional hearings and elsewhere, Dr. Wynder will take the position that his research has had to be supported by foreign tobacco interests because he could find no support among the American industry.... Objections to his work...would be severely weakened by the fact that a tobacco industry had supported his work.

The strange story of Klaus D. Brunneman:

In September 1977, Brunnemann, as senior author, and Dietrich Hoffmann of Ernst Wynder’s American Health Foundation published an important paper, “Assessment of carcinogenic volatile N-nitrosamines in tobacco and in mainstream and sidestream smoke from cigarettes” (Cancer Research 1977;37:3218-3222, submitted April 1977) in which they show that sidestream smoke contained 20-40 times higher concentrations of nitrosamines than mainstream smoke. They concluded, “Although, at present, there is no evidence to indicate that sidestream smoke of tobacco products may be carcinogenic to humans, the analytical data of this report should be followed by...analysis of indoor air polluted by smoke. If such investigations support our finding, epidemiologic studies are indicated to examine the carcinogenic potential of tobacco sidestream smoke for nonsmokers.” The confirmatory epidemiologic studies of Hirayama and Trichopolous were published just three years later, bitterly and openly contested by the VdC, although accepted in private (see “Shameful Science,” entries for 12 and 18 June 1981).

In December 1977 Brunnemann presented his findings to the VdC (PM 1003717764 - 7766, translation of Adlkofer’s minutes), and, according to Adlkofer’s notes, began to hedge on the implications of his own paper: “The previous experiments of Hoffmann and Brunneman, as was stated by Mr. Brunneman, should be taken as models which do not necessarily imitate reality.... By no mean s should this be considered that there is a connection between the formation of nitrosamine in sidestream smoke and the nitrosamine content within the air of an enclosed space.”

According to RJR scientist Frank Colby, “The German Cigarette-Industry Association and many of its members are unduly alarmed by the nitrosamine issue.... Because of the concern of the German Industry, shortly after the Hoffmann/Brunnemann publication, they decided to check their data.... The efforts of the German Industry are now being completed in collaboration with Philip Morris in Neuchatel, who have purchased the necessary and very costly equipment.” (30 June 1978, RJR 500942645 at tobaccodocuments.org.)

Philip Morris did more than purchase equipment. They hired Brunnemann to work at their R&D site in Switzerland (Colby: “Since PHILIP MORRIS was interested in that controversy, they decided to hire Dr. BRUNNEMANN away from Dr. WYNDER,” 12 June 1978, RJR 504821200 at tobaccodocuments.org), and apparently without informing Ernst Wynder. In a memo to the files, 9 June 1978, by PM senior scientist Robert Seligman recounts a meeting VdC scientists had with Wynder who “asked them if they knew to which cigarette company in Germany Brunneman went to work for. They replied that Brunnemann was not going to a [hand-written in: German] cigarette company and they offered no further information.”

During his time at PM, Brunneman essentially repeated his 1977 study, this time with PM scientists Walter Fink and Fritz Moser as co-authors (“Analysis of volatile N-nitrosamines in mainstream and sidestream smoke from cigarettes by GLC-TEA”[gas liquid chromatography with thermal energy analyzer, the same method as before]). Brunnemann was asked by Prof. Schmaehl, chair of VdC’s Research Council on Smoking and Health, to submit the results at the Symposium “Risk Assessment of N-Nitroso Compounds for Human Health, held at Schmaehl’s Cancer Research Center, 21-23 May 1979 [the symposium manuscript is found at PM 1003723906 - 3922; the paper was published in Oncology 1980;37:217-22]. The paper, however, required editing and approval by Seligman: “Dear Dr. Seligman, thank you for your Telex and the suggestions for the Heidelberg manuscript. I have now taken out the Hoffmann data and also incorporated your valuable corrections. Please find enclosed two copies of the new version (one for Dr. Osdene).” (19 April 1979, PM 1003723905.)

One “valuable correction” was probably the sentence that read, “One should be aware, however, that the conditions used in the experimental chamber are not realistic in terms of human exposure to tobacco smoke since five cigarettes smoked in a room of 30 m³ size already cause a degree of irritation which prevents anyone’s remaining in such an environment.” (at 1003723912).

The crucial difference between the AHF and PM studies was that in the latter the mainstream and sidestream nitrosamine values were one-third to one-quarter of the earlier study. The difference was ascribed to “different experimental variations.”

(-3912.)

It is a matter of some debate whether Hoffmann “insisted” to have the AHF data removed, as Brunneman claimed, or was so put out at not being included or AHF’s work acknowledged that a law suit was threatened (9 May 1979, Brunnemann to Seligman, PM 1003723894, 17 April 1979 AHF Special Counsel Klarberg to Brunnemann, PM 1003723900). As a result Brunnemann’s paper was read by someone else, but the true winner was the cigarette industry as told by Hausermann to Seligman in a 9 May 1979 letter (PM 1003723893): “The VdC gets the paper presented and the lower nitrosamine figures “officially” sanctioned. Neither Mr. Brunneman nor Dr. Fink will attend the meeting; the risk of having them involved in discussions is therefore avoided. Dr. Hoffmann gets satisfaction; but might somehow lose face.”

The story gets more curious: By spring of 1980 Brunneman was back at AHF (27 March 1980, letter from Brunnemann to Osdene, “Thank you so much for everything,” PM 1000025168). Colby commented on Philip Morris’s hiring of another Wynder researcher (J.J. Piade), “I am at a loss to understand this, especially after the bad experience which they have had with Dr. Brunnemann.” (7 November 1980, RJR 511205410 at tobaccodocuments.org.) Review of the literature shows him then co-authoring with Hoffmann, Hecht and others some of the most damning scientific studies linking tobacco-specific nitrosamines to carcinogenesis in several parts of the world, including the famous article on passive smokers’ excretion of nitrosamine metabolites published in the New England Journal of Medicine in 1993 (see entry below for 23 November 1993), one attacked in the journal by VdC contractor Ueberla (see 13 November 1993 in “Shameful Science”).

To complete the irony, Hoffmann and Brunnemann also validated Dontenwill’s hamster study, this time using tobacco-specific nitrosamines to induce laryngeal tumors! (IARC Scientific Publication 1982;41:299-308.)

5 June 1979, Trip report, RBS [Robert Seligman], “Hamburg Meeting,” PM 1003717691 - 7694.

Another result of Brunnemann’s paper was to help the industry shift the focus away from volatile nitrosamines from smoke to nonvolatile nitrosamines formed within the body from ingested food nitrates.

Dr. Adlkofer then discussed the nitrosamine conference in Heidelberg.... It was noted that the Brunnemann paper received little comment except that the sidestream number given by Brunnemann was only one-third of that previously published by Brunnemann and Hoffmann. Probably the most interesting finding at the conference was the fact that in vitro formation of nitrosamines was estimated by Dr. Tannenbaum of MIT to be 10 [micrograms] per day per kilo.... Thus, nitrosamines taken in via smoke, beer, etc., are minuscule sources of nitrosamines compared to those which are formed in vitro.

The quest for a safer cigarette by the quasi-autonomous Research Council seemed also to be undermined: “Dr. Adlkofer further stated there was no attempt, or any effort, on the part of the industry to produce a less hazardous cigarette under Dr. Schmaehl’s programs.” Perhaps this was Adlkofer’s move to control the research for the VdC: “A whole new scheme will have to be developed under the umbrella of the Hanover [sic] Tumor Center. The VDC will establish a research department which will do tumor work; yet, the VDC will ‘hide’ some of their studies as well.” VdC reach extends beyond biologic research by purported influence on WHO: “The VDC is also influencing publications which will be presented at the Fourth World Health Conference that deal with the cost to the economy due to smoking.”

12 October 1979, letter (in translation) from Prof. Schmaehl to Adlkofer, transmitted to PM chief counsel Holtzman, PM 1003717688 - 7689.

A cri du coeur, and a threat to “blow the whistle”: Schmaehl realizes that the rug has been pulled out from under him, and that the VdC will not do anything that could conceivably harm the tobacco industry:

This letter refers to the conversation that you and I had on September 27th, 1979, with Drs. Koenig and Brueckner [VdC scientists] and in which we discussed the for me essential experiments on dose effect relationships of high tar cigarettes compared to low tar cigarettes. Such experiments are completely indispensable in the arguments on a safer cigarette, especially if one supports such efforts publicly. In our conversation it was argued that the Industry could not support such experiments since this might prove that the previously manufactured products have a carcinogenic effect and that such experiments could especially not be supported because they would be financed with Industry funds. I am totally unable to follow these arguments. Especially, since, for example, in the former Dontenwill Institute such dose effect relationships were already investigated and were financed by the Industry. The same applies to the detailed investigations by Mr. [Peter] Lee at the BAT Research Institute in England, which were likewise financed by the Industry. Therefore the arguments made by Drs. Koenig and Brueckner do not hold. I want to tell you again that in case this project, which is essential from my point as well as for the other members of the Research Advisory Board, is refused by the Industry, I will carry out such investigations in my Institute on my own account; in that case I will, in my publication of this work, call a “spade a spade.” [NB. Here the translator writes a footnote: “Dr. Schmaehl uses a German colloquialism which literally translates “I shall clearly identify horse and rider’, which in German is -- at least implicitly -- a bit more threatening than just naming brand names.”] It is self evident that if such experiments are carried out in Heidelberg, they will be done without being influenced by the Scientific Advisory Board or by your industry, and that I will only test what interests me, i.e., the dose response relationships of the different amounts of condensates, without testing questions you are interested in, i.e., the effect of nicotine. These experiments which I want to carry out and which I have requested you to approve for me to do for about one and a half years, will help to prove the correctness of the approach taken by the Scientific Advisory Board with reference to the promotion of low tar cigarettes. I am totally at a loss to understand that these arguments are not accepted by the Industry, because they are designed to show that we are on the way to produce something better. Your attitude would indicate a willingness on the part of the Industry to no longer follow this approach which the Industry itself had participated in initiating and had promoted and supported.

24 January 1980, memo from R. Fagan to R.B. Seligman, PM 1003717661.

Discussion of Verband’s use of electrstatic precipitators rather than Cambridge filters for tar and nicotine measurements.

Hand-written note from RBS at bottom: “Discussed w Max Hausermann -- he informed me, in confidence, that the Verband wants the two measurements so that there will be debate and confusion re tar methodology. Thus, when the Govt. Taxes on the basis of tar levels, the cigt industry can buy some time ostensibly to get the method standardized.” (See “Shameful Science, 14 January 1980 entry for background.)

9 October 1981, report from Verband, "Confidential PR-Status Report 1981 Smoking Issues in Germany," BAT 109869093 - 9112, from the BAT Guildford Depository, found at <www.cctc.ca/ncth/guildford>

Whatever was said in private meetings, Verband played a loyal role vis a vis the entire industry in its public relations campaigns, whether against taxation, health warnings, harassment of anti-smoking groups, cultivating journalists and government officials, impugning the work and character of researchers finding harm in cigarettes, and creating citizen front groups from industry employees:

Therefore, the Verband jointly with the Tobacco Workers’ Union holds regular smoking and health lessons where employees of the different member companies are taught the basic issues and how to defend industry’s positions.... Today the Verband disposes of a network of more than 200 employees all over the Federal Republic. They keep us informed about their local media scenery and they write letters to the editor, if necessary. It is planned to organize and structure this PR force in a way comparable to the American Tobacco Institute’s TAN [Tobacco Action Network] with similar tasks and responsibilities. -9099-10)

Verband continued to ingratiate itself as a "respectable partner" with the scientific and political communities:

The Verband has in 1981 intensified its relations to the press and other media. Furthermore it has strengthened its ability to create ‘good news’ by credible third parties as a counterbalance to the continuous flow of bad ones, many of which come from abroad. Another key role is held by the scientific and political community. Besides good relations on an individual basis much public credit has been given to the industry by its engagement in the work of the independent ‘Research Council Smoking and Health.’ It documents industry’s serious and responsible intention to cope with the medical challenge of smoking and health. It made industry not a beloved but at least a respectable partner to serious scientists and health officials." (- 9098-9)

25 March 1982, memo from T.S. Osdene (PM senior scientist) to list, “Coumarin,” PM1003225739.

“Dr. Adlkofer mentioned to me in confidence that coumarin [an additive] has run into some biological problems confirming Dr. Gaisch’s earlier memorandum. It is my understanding that in a large scale feeding study (I believe in rats) a number of tumors have occurred in the digestive tracts. This occurs only at the highest levels of coumarin.” [NB. See entries under “coumarin” in “Shameful Science.” In fact, the evidence of liver damage and carcinogenicity was available to the Verband as early as 1981, and there was still sentiment to fight to keep this flavorant as late as 1988.]

10 July 1984, letter from S.B. Evelyn (BAT scientist) to K. Kohnhorst (B&W counsel), B&W 100470844 - 0845 at cdc.gov/tobacco/industrydocs, Minnesota Select Set.

“I now understand that metastases have been confirmed in one animal from the highest dose level in both the German and UK studies. On the basis of this evidence, it could be claimed that coumarin is carcinogenic at (unrealistically) high dose levels in the rat. This evidence, if it is substantiated, may well be sufficient to ensure that regulatory bodies will not accept the use of coumarin.”

5 November 1985, draft report from AW Hayes (RJR scientist) to SL Jowdy (RJR counsel), RJR 505743303 - 3315, from <www.tobaccodocuments.org>

Report on visits to various German scientists funded by the Verband, researching constitutional causes of cancer (as opposed to external causes). One such was Dr. Grossarth-Maticek whose thesis that lung cancer was of psychosomatic origin, an idea that pleased both Frank Colby and Franz Adlkofer (see first installment of "Shameful Science," 21 May 1982, 12 May 1983). Grossarth-Maticek even landed a favorable interview in the German edition of World Health, WHO’s publication. "We discussed the work of Grossarth-Maticek.... They are very dubious about what he has done and, in fact...referred to him as one who was dishonest with his data." (- 3304)

29 August 1985, translation-report by F. Breidbach, PM 2501458393 - 8394.

An article on 26 July 1985 in the Tabakzeitung indicated that German cigarettes contained diethylene glycol (basically, anti-freeze, a potent kidney toxin). The Deutsche Presse Agentur picked up the story and the magazine NATUR was going to feature it. Verband obtained an injunction against the publication in NATUR which had commissioned its own analyses from an independent laboratory, validating the finding.

In agreement with the industry, we have not reacted to this [Tabakzeitung report] and some other unimportant articles, in order not to add oil to the fire in the media.... Our priority now is to prevent the editor in chief of NATUR to publish a new article....

10 October 1989, telex from Ferdi Breidbach (Philip Morris Germany) to Cynthia von Maerestten (PM Europe), "Boca Raton Progress Report," PM 2500019912 - 9913.

In 1989, the Chairman of Philip Morris International, Geoffrey Bible, initiated a wide-ranging series of strategies to counter the anti-smoking movement, targeting WHO in particular.

Named after the city in Florida where the planning meeting was held, the "Boca Raton Action Plan" generated much activity around the world, described in several reports. See in particular PM 2503005015 - 5050 and 2501045143 - 5147. Breidbach here reports on what the Verband is doing to hold up its end of the work in Germany.

The VDC [acronym for Verband der Cigaretten-Industrie] sends scientists to the various scientific conferences amongst others recently the "Therapie Woche" (therapy week) in Karlsruhe for German specialists in internal medicine. One topic at the Therapie Woche was "Passive smoking and its effects on health". The conclusion of the discussion was that the majority of scientists agreed that passive smoking cannot be classified as a health risk.... The German airline Lufthansa has introduced a test smoking ban on 2 short circuit flights (40 to 50 minutes flying time) national flights. The VDC has an actionplan to counter this Lufthansa activity.... At the present there are only about 1000 restaurants in Germany which have non-smoking areas.... The VDC works with the DEHOGA (German Association of Hotels and Restaurants). The DEHOGA is against divisions in restaurants for specific non-smoking sections. The VDC is preparing a brochure at the present to send to the restaurant-owners.... One smokers rights group in Germany is quite promissing [sic] at the moment. The "Raucher wehrt Euch" (smokers defend yourselves) RAWE who fight for smokers rights. VDC assists this association which is having its first successfull [sic] publications also successfull press and television appearances.... Our journalist programme has confirmed itself. It consists of the following effective activities: [Breidbach here describes dinners, study tours to the USA for some 20 young journalists and editors, among other activities.]

25 February 1992, memo from Lutz Mueller to RJR staff in USA, "VdC Project Proposal," RJR 509658834.

The proposal comes from Prof. Franz Adlkofer’s Munich laboratory, written up by Dr. Gerhard Scherer, and is for testing a range of biochemical events volunteers’ exposure to active and passive smoking, the "real life" experiment often discussed by the Verband research committees and as early as 1977. Mueller takes a cautious view: "It is particularly with regard to these new research fields that I need your input concerning their appropriateness and their potential risks and value."

14 April 1992, memo from Mueller to RJR staff in USA, "Paper and abstract on TSNAs [tobacco specific nitrosamines]," RJR 508759507.

Mueller mentions a study by Hubert Klus of the Austria Tabakwerke to be submitted by "Tony" [Tricker] in abstract to the ACS [American Chemical Society] meeting in August 1992, Washington DC. Mueller is relieved that a joint paper with Adlkofer will not appear because of flaws in the Munich experiments.

[NB. A paper by A Pachinger, H Begutter, I Ultsch and H Klus appeared in the Journal of Chromatography 1993; 620 (1):55-60, on technical measurements of TSNAs. Another paper from the Adlkofer lab with Klus as co-author (AR Tricker, G Scherer, C Conze, F Adlkofer, A Pachinger, H Klus) appeared in Carcinogenesis 1993: 14(7): 1409-14, and found a particular TSNA -- iso-NNAC -- in tobacco and smoke but not after oral ingestion of nicotine.]

16 April 1992, memo from Mueller to RJR staff in USA, "VdC Project Proposal," RJR 508759355.

The title of the proposed study is "Exposure study for the assessment of the effects of tobacco smoke on various biological parameters." Adlkofer has promised Mueller that RJR staff can see the data with "preferential and immediate access" so that a decision about publication can be made.

19 May 1992, memo from Mueller to RJR staff in USA, "Industry-sponsored Research Foundation in Germany," RJR 511089526 - 9529.

With the creation of Verband’s and Adlkofer’s new VERUM foundation, both PM and RJR are worried about the direction of research. The VdC Scientific Department agrees to provide funding to VERUM to "scientifically clarify claimed associations [between tobacco and health] and to related them to the general risks of life." Specifically, VdC would like to see research "into the relevance of nicotine itself and in interaction with other constituents of tobacco smoke regarding the pathogenesis of chronic diseases claimed to be associated with smoking." Also, investigations into the health effects of passive smoking should take into account "additional exogenous and endogenous factors which may be important in pathogenic mechanisms." [NB. We see here the continuing attempts to exonerate nicotine, and to shift blame for any illness in non-smokers away from exposure to passive smoking.]

21 May 1992, memo from Mueller to RJR staff in USA, "Industry-sponsored Research Foundation in Germany, RJR 511089113.

PM’s objections to VERUM research on nicotine "are not necessarily a matter of principle," but PM’s Dr. Walter Fink "is in favor of research with a focus on the benefits of nicotine to the smoker." Mueller comments, "It is my feeling that our positions may not be so different after all."

22 January 1993, memo from Mueller to Charles R. Green (RJR scientist), "VdC ETS Exposure Study," RJR 508801060 - 1061 and 22 January 1993, G. Scherer, "Translation, Minutes of the Meeting, summarizing Study Results," 508801062 - 1063 (originally attached but recovered as a separate document).

Adlkofer plans a presentation of the 1992 Exposure Study results. Mueller reports to his superiors,

I have given Dr. Adlkofer clear advance warning that I expect the Reading Committee to be able to have a look at this presentation prior to the Titisee Meeting [in Germany] and that we are somewhat worried concerning the possibility of the results from the Exposure Study being over-interpreted. I am going to push the issue further.

Mueller had reason to be "worried." The summary of the results attached to this memo show

...extremely high ETS [indoor] concentrations (CO at 20 ppm, particles at 3 mg/m3, nicotine at 80 &g/m3). The poor quality of air on all study days is also obvious.... The uptake of the tobacco smoke constituents CO and nicotine demonstrates that the smokers in the study have smoked very intensely.... The exposed nonsmokers were challenged with ETS in an extremely strong way (2-3% COHb) compared to ETS exposed people in daily life.... Data from Prof. Ruediger indicates an increased rate of single strand breakage [DNA damage] following smoking but not following ETS exposure.

30 September 1993, research proposal by Gerhard Scherer, "Study on Various Acute Effects Following Exposure to Tobacco Smoke," RJR 5110709138 - 9147.

Scherer proposed to have non-smoking volunteers be exposed for four 8-hour days to heavy smoking by smokers "under real-life conditions," in a 67 m3 room with air conditioning, with various biologic measures being taken, and anti-oxidant vitamins supplied, ostensibly to reduce the oxidative stress on DNA by smoking.

1 October 1993, memo from Mueller to RJR staff in USA, "New Project Proposal for a Study to be Conducted at the VdC Munich Laboratory," 511709137.

Mueller passes on Scherer’s study proposal to his superiors: "And we certainly would like to exert our influence to the fullest extent possible to really make the new study a good and reasonable one and as useful as possible for the Verband and for the Industry."

25 October 1993, proposal by A [nthony] Tricker, "Justification for the purchase of a Thermal Energy Analyzer (TEA) and gas chromatograph for nitrosamine analysis. Research programme for the V.d.C. Laboratory in Munich," PM 2029041320 - 1331.

Tricker, a tobacco scientist with the Verband, notes the need to respond to Hecht’s study but under "real-life situations," meaning not like in a smokey bar; in Hecht’s experiment the concentrations of nicotine and NNK in the chamber exceeded by several fold those in environmental studies of smokey bars and offices. In order to study nitrosamines in ETS, including both a full replication of the Hecht protocol and a "real-life" study, better analytic equipment is necessary.

November 1993, hand-written notes by unknown author, "Problems with EXPO 92 [the ETS exposure study by Scherer]," PM 2029041231.

In addition to some technical issues, writer asks why antioxidants should be used when ETS is supposed to have no effect. A further entry reads: " - discrepancy between publications and internal statements...."

23 November 1993, memo from Mueller to Donald J. deBethizy (RJR scientist), "TSNA Analysis," RJR 514940121 - 0122.

A paper critical to the matter of ETS by Stephen Hecht of Ernst Wynder’s American Health Foundation had just been published five days before in the prestigious New England Journal of Medicine ("A Tobacco-Specific Lung Carcinogen in the Urine of Men Exposed to Cigarette Smoke," NEJM 1993; 329: 1543-6). Hecht showed unequivocally that after three hours exposure (in two 90-minute sessions) to machine-generated sidestream smoke in a 16m3 room with limited ventilation, non-smokers had NNAL nitrosamine and its metabolite NNAL-glucuronide (both derived from NNK, a potent lung carcinogen in rodents) in their urine. They also took up nicotine whose concentrations in the room were "comparable to those in a heavy smoke-polluted bar." Their uptake was about 1% of that by actual smokers, reflecting the approximate incidence of lung cancer compared to smokers. This was the first of several studies by Hecht and others linking ETS biologically to the epidemiologic data on lung cancer in passive smokers. Mueller complained, "We (i.e. Adlkofer and the Verband) have known about this forthcoming publication for more than half a year...we simply wasted our time and now find ourselves in the position of not being able to respond to Hecht’s paper in a pointed and forceful way." Mueller then asked for RJR’s support for better TSNA analytic facilities for Adlkofer’s laboratory. A hand-written note at the bottom (? from deBethizy) indicates that "Doolittle [David], Coop [Cooper Rees], Charly [Charles Green], BC [Bill Caldwell] should "plan strategy for TSNA/ETS Research."

December 1993, research proposal Gerhard Scherer and Anthony Tricker, "VdC Project Proposal, Studies on various acute effects following exposure to tobacco smoke," RJR 508792698 - 2725.

A 28-page elaboration on the 30 September proposal to expose non-smokers to heavy doses of man-made cigarette smoke, eight hours a day for four straight days, sidestream and mainstream. Numerous ambient air and biochemical/biological determinations to be run, including studies of DNA damage, the Ames test for mutagenicity in the urine, and nitrosamine (NNAL and NNAL-glucuronide). The study also aimed to provide anti-oxidants (vitamins C, E and beta-carotene) to see if they ameliorated any of the oxidative damage to DNA. A remarkable finding from a previous study given on page 27 (Appendix II) indicates that passive exposure increased benzene in non-smokers’ breath by 4.5-fold, and by 7.5-fold in the smokers. Benzene is listed by IARC as a Class I carcinogen.

13 December 1993, hand-written notes, unknown German-speaking author (?Helmut Reif), commenting on the Scherer-Tricker protocol, PM 2029041308: " - I like the active contribution of Tricker. - why such hurry by A[dlkofer]?.... who has Tricker’s manuscripts [28] and [29] on nicotine inh[hibition] of metab. Act. Of NNK and Hb adduct form.?.... did he use F-344 rats? (because of correlation to lung adenocarcinomas in ref. 3, 30, 31) (Tricker used Wistar rats)....- what is the future of Tricker !?.....- followup on nicotine interference?...."

PM 2029041176: "Richard [Carchman]: ethical concern; German authorities should not accept it, even if they agree, PM would not do the study.... order of the studies shows [circled:] ‘Spirit of Winston-Salem’. " [NB: Philip Morris had been alarmed by earlier VdC-sponsored experiments with ETS on humans, children and adults. See PM 2047903790, 2047903795, 2023222729 on 1, 4, and 25 October 1992; and PM 2501004082, 3 September 1993.]

3 February 1994, memo from William Caldwell to Dr. Carl Ehmann, "Subject: NNK," RJR 514428169.

Caldwell explains the concept of nitrosamines and the significance of Hecht’s study:

For years workers at the American Health Foundation (AHF) and other institutions have built a case for NNK as the "cause of lung cancer" in smokers. The recent report by Dr. Hecht of the AHF that metabolites of NNK were found in the urine of nonsmokers exposed to high levels of sidestream smoke has been interpreted by the AHF as a direct link between ETS exposure and lung cancer risk in nonsmokers. Even though AHF’s hypothesis that NNK is the cause of lung cancer in smokers suffers from serious flaws we can expect their views on NNK in ETS to gain acceptance. As a result, TSNA exposure is a high impact external issue confronting the entire industry.

[NB. Ernst Wynder, founder and leader of the AHF always doubted the epidemiologic evidence implicating ETS, and was willing to lend his voice to the industry on that point. It is a measure of his scientific integrity that Hecht’s article came out of the AHF. Hecht has told me that Wynder never tried to influence the paper or its publication in any way. We may compare this ethical approach to science to the Industry’s "Shameful Science."]

Caldwell also explains, "At RJRT R&D we have found that nicotine and other smoke components may protect against the reported cancer causing properties of NNK."

[NB. A 1994 research study, C. Kutzer, E. Richter and S.E. Atawodi, "Effect of nicotine and cotinine on NNK metabolism in rats," PM 2501138290 - 8293, shows no effect of high doses of nicotine and cotinine on excretion of administered NNK nitrosamine, but did reduce by half the number of hemoglobin adducts, which is another measure of NNK binding activity. Also see E. Richter, etal. "Tobacco-specific nitrosamines -- metabolism and biological monitoring of exposure to tobacco products," Clinical Investigation 1992; 70:290-4, showing two nitrosamine derivatives of nicotine are also potent carcinogens.]

21 February 1994, agenda, "Biological Effects of Sidestream Smoke Exposure [BESSE]," PM 2029198972.

The industry gathered in Stockholm to discuss the Verband studies on direct exposure of humans to ETS in an attempt to respond to Hecht’s work. The topics included Adlkofer’s review of Verband’s earlier work on ETS, discussion of Scherer’s "EXPO 93" proposal, Tricker’s presentation on the requirements for TSNA research.

22 February 1994, conference summary, Roger Walk (PM/Neuchatel) to Anthony Andrade (PM counsel for EEC region), "BESSE meeting, Stockholm, 21 Feb. 94," PM 2023049185 - 9187.

Participants came from Verband, PM, BAT, RJR, Austria Tabakwerke, Reserca.

The purpose of the conference was to define the key research areas on ETS the industry should initiate/support. The emphasis was on biochemical and metabolic studies of TSNAs, the influence of nicotine on carcinogenesis, but not on the "real-life exposure" as there was no consensus between the group and Dr. Adlkofer.

8 March 1994, trip report, David Doolittle, "Report on BESSE (Biological Effects of Sidestream Smoke Exposure) Meeting," RJR 508812179 - 2183.

RJR chemist Doolittle did his own name one better by advising Verband and RJR to do nothing. After a vigorous attack on Adlkofer’s scientific ability and claims that Verband had shown no hazardous effect of ETS on humans ("...none of these studies (as far as I know) have ever been accepted for publication in peer-reviewed journals, and are virtually unknown in the scientific world."), Doolittle argued against the "real-life" (ETS in a bar) study:

I think this study would not only be unhelpful, but would probably be uninterpretable and leave the door open for prohibitionists to interpret in a malicious manner. Therefore, I feel strongly that this study should not be done. There are only two possible outcomes from the NNAL and NNAL-glucuronide measurements – either you will find it, or you won’t find it. If you do find it, all it does is confirm the American Health Foundation thesis that non-smokers are exposed to biologically relevant doses of NNK. We would not be able to put this into perspective in any way, nor be able to argue with any effectiveness that this level of exposure is biologically insignificant, since we have no data to support this position [emphasis added]. On the other hand, if we do not find the metabolites in the urine; there are only two possible interpretations. The first interpretation is the NNK has been metabolized by the nonsmoker to active metabolites and is now bound to the individuals’ DNA, RNA and protein. This obviously is an undesirable interpretation of the data. The other interpretation would be that the method is simply too insensitive to detect the metabolites at a low dose level.

Doolittle goes on to describe the kind of study he would favor, one with predetermined outcomes:

In summary, in my mind the ideal would be to develop a data set which shows the following: First, people are exposed to very, very low levels of NNK in ETS. These data will likely be developed by other individuals, so the industry needs (at most) to only confirm these numbers with limited studies. Second, the small amount of NNK absorbed by individuals exposed to ETS is biologically insignificant for the following reasons: 1) It is effectively detoxified and excreted by the body. 2) The biological activity of NNK is inhibited by nicotine and cotinine which will always be present in gross excess relative to NNK, both in atmospheres and in the body. 3) The level of nitrosamines received by an individual following ETS exposure is insignificant compared to nitrosamine exposures from other sources, such as food.

17 March 1994, table, no author identified, "VdC Research Program on TSNAs," PM 2028361491.

Seven levels of study are identified: discovery of an unknown nitrosamine that might mimic NNAL in analysis; real-life exposure ETS study; comparison of other ETS markers with urinary NNAL; ETS exposure in controlled setting; same, in a "steady-state" setting; replication of Hecht’s study with a reference cigarette; metabolic study of nitrosamine-glucuronides. The table indicates what the Verband Science and policy meeting on 18 March 1994 (PM 2021512455 - 2460) confirmed: The Hecht-replication study was "unnecessary; not to be done!" Only the first and last studies were deemed "necessary."

25 March 1994, memo, Mueller to RJR staff USA, " VdC Research Program on TSNAs, RJR 508725670.

"By the way, any thoughts about reproducing Hecht’s exposure study have now been dropped completely."

4 May 1994, memo, Mueller to RJR staff USA, "VdC Nitrosamine Research," RJR 514890719.

The memo indicates at least 8 studies put forward by the Verband. The 8th is to measure TSNA and NNAL in an ETS atmosphere (no non-smokers exposed) to compare to the NNAL concentrations reached in Hecht’s study. [NB. No other documents on ETS research were found until 1997 in either RJR or PM web sites.]

2 June 1997, memo from Mueller to Doolittle, Green and Ogden, "Publication Draft on Haemoglobin Adducts," RJR 517623508.

Calls attention to a publication, "Haemoglobin adducts from aromatic amines and tobacco-specific nitrosamines in pregnant and non-smoking women," research done by Elmar Richter (who invented the technique to show binding of carcinogens to hemoglobin protein as a surrogate measure of binding to DNA) at the University of Munich in collaboration with the Verband’s Munich laboratory. [NB. This paper has yet to appear in a peer-reviewed journal as of January 2000.]

13 June 1997, minutes, no author, "Meeting of the [Verband] Scientific Policy Committee," PM 2063653531 - 3542.

Despite the injunctions not to do human ETS exposure studies, apparently Gerhard Scherer and Elmar Richter teamed up to expose smokers and non smokers to TSNAs, and the committee is nonplused by the findings:

One of the striking findings is that there is little difference between smokers and nonsmokers with regard to the haemoglobin adduct rates for tobacco-specific nitrosamines. This phenomenon, also observed by other working parties, requires an explanation. An attempt should also be made to balance the account for total nitrosamine load, i.e. other sources of nitrosamines should be identified and quantified.

Another item discussed in this meeting included the likely discovery of nitrosamines in cigar smoke: "One of the foremost investigators is Dr. Dietrich Hoffman [of American Health Foundation]. The report...will certainly serve as a basis for political intervention against cigar smoking." The committee agreed to finance a special edition of the public health journal Gesundheitswesen on request by industry-consultants Professors Gostomzyk and Atteslander, summarizing the Alpbach health forum on "multimorbidity and virtual risks," but only "if it contains contributions relevant to us." An appendix to the minutes is titled: "Briefing on Tobacco Genetic Modification." The rationale for GM included: better quality leaf, reduced pesticide residues, and "longer term modifications might be possible that enhance the quality of tobacco leaf for the consumer." The Verband’s Scientific Commission gave its support to the technology, "based on its wide-spread application in other consumer products....in order to encourage further research and development of new tobacco varieties."

Another appendix is called, "Genetically Modified Tobacco (GMT): Issues to be considered for VdC-sponsored contract testing of German brands." Here, the Scientific Committee appears to be worried that German brands already contain genetically modified tobacco and propose to do testing by an outside contractor, but, "Can Hydrotox-GeneScan ensure that the strictest confidentiality on the work carried out and the results obtained is maintained by all personnel involved in the project?" "The risk of finding GMT leaf in samples of the top twenty brands of the German market appears to be very small. [However,] the unlikely

possibility of GMT detection by the VdC-sponsored or a third-party testing cannot be ruled out."

14 October 1997, memo, Mueller to William Caldwell, "NNK Metabolites in Non-smokers," RJR 517623502 - 3503.

Despite PM’s and RJR’s adamant opposition to ETS exposure studies by the Verband, Mueller reports, "Some time ago, the Munich Laboratory of the Verband conducted a study to investigate the uptake of NNK by smokers and non-smokers. Regarding non-smokers exposed to ETS, the analytical data indicated that they were exposed to about 1% of a smoker’s average NNK dose [NB. Similar to Hecht’s results]. No steps were taken at that time to communicate these results externally or to publish them." [Emphasis added.]

Mueller goes on to say that since Hecht presented new data in 1997 at the American Chemical Society meeting showing NNK in exposed non-smokers approximated 1-2% that in smokers [NB. 1-3% in his most recent review, "Tobacco Smoke Carcinogens and Lung Cancer," Journal of the National Cancer Institute 1999; 91: 1194 - 1210.], the Verband wanted the chance to present their own findings at the American Association for Cancer Research meeting in 1998. "It gives an opportunity to interpret the data and put things into perspective," Mueller explains to his superior.

30 March 1998, minutes, by Helmut Reif, "Abbreviated Report on VDC/WPA Conference March 27, 1998," PM 2060566162 - 6163A.

The VdC is recruited to launch an advertising campaign warning smokers against smoking around children. "The poster subjects show baby faces, children scenes, and the captions ‘Please, stop smoking.’ The thrust goes to good education." Gerhard Scherer to present a poster on ETS exposure in children using nicotine and benzene as markers, at the International Symposium on Passive Smoking and Children, Essen, Germany, August 24-26, 1998. [NB. The results were published in 1999: G. Scherer, etal., "Assessment of the exposure of children to environmental tobacco smoke (ETS) by different methods," Human Experimental Toxicology 1999; 18: 297-301. The study shows children in homes with smokers were exposed to ETS in a day an average of 3.1 hours, ten times as much as children in non-smoking homes; they absorbed nearly twenty times as much nicotine and cotinine.]

6 May 1998, minutes by Helmut Reif (inferred), "Abbreviated report on the main topics of the meeting" of the Verband, PM 2060568409 - 8410.

The German MAK commission did not accept Verband’s submissions against declaring ETS a carcinogen, calling it III A 1 ("unequivocally carcinogenic substances, shown to induce malignant tumors in humans"). Continued discussion on detecting genetically modified tobacco in German brands. "The VdC takes over from Reemstma a research program on development of novel methods for GMO analysis that had been contracted out to Gene Scan."

17 June 1998, minutes by Helmut Reif (inferred), "Abbreviated report on the main topics of the meeting...of the Scientific Commission (WPA) of the German Cigarette Association (VDC)," PM 2060568313.

The Commission faults a study showing oxidative stress due to ETS in the workplace (which may reasonably be called a "real life"situation): DJ Howard, etal., "Environmental tobacco smoke in the workplace induces oxidative stress in employees, including increased production of 8-hydroxy-2'-deoxyguanosine," Cancer Epidemiology, Biomarkers and Prevention 1998; 7:141-6). The marker is an oxidative DNA mutagen, linked to both coronary heart disease and cancer. The authors find exposure to ETS significantly increases the marker in the blood of non-smokers in the work place by 63%. The Commission concludes: "The paper was found to be full of factual errors and not in concordance with similar papers published earlier on." [NB. Howard also published a paper showing that exposed non-smokers taking antioxidants and minerals had lower levels of the mutagen in their blood by 62%. "Oxidative stress induced by environmental tobacco smoke in the workplace is mitigated by antioxidant supplementation," Cancer Epidemiology, Biomarkers and Prevention 1998; 7:981-8.] The Austrian Government decided that in relation to genetic modification cured, fermented tobacco was in legal terms no longer an organism. VdC plans research to determine how long a complete gene survives curing. The Commission seeks a successor to Prof. W. Richter, immediate past scientific advisor to VdC. "The profile for this position asks for ensuring good personal contacts to academia in Germany."

17 July 1998, memo from Helmut Reif to Cathy Ellis (PM Director of Research), "Pre-information on Topics of the next VdC Meeting, July 22, 1998," PM 2060569980.

"Several letters on Kawachi et al. (passive smoking & CD) sent by Adlkofer, Coggins, Gori, and Brennan, as well as the reply by Kawachi will be discussed."

[NB. I. Kawachi of Harvard published "Passive smoking and coronary heart disease," Cardiologia 1998;43:667-75, a review of the literature. Unmentioned by Verband is the paper by G. Howard, etal. from Wake Forest University in Winston-Salem, North Carolina showing unequivocally that smoking and exposure to passive smoke accelerated atherosclerosis over three years, by 50% in smokers and 25% in exposed non-smokers. See "Cigarette smoking and progression of atherosclerosis: The Atherosclerosis Risk in Communities (ARIC) Study," JAMA 1998; 279: 119-24.]

12 August 1998, memo from Helmut Reif to Cathy Ellis, "PM Documents on the web," PM 2060578328.

Professor Adlkofer scans the Philip Morris tobacco document website:

Prof. Adlkofer informed me in a phone conversation today that he found a lot of documents on the Internet that dealt with private and confidential information on research projects that he handled while acting as Scientific Advisor to the VdC.... Prof. Ueberla contacted recently Prof. Adlkofer and expressed dismay about the fact that he was not even informed about these publication steps. He plans to check whether the publication of these documents constitute a breach of personal privacy according to German law.

September 1998, research proposal, no author, "Proposal outline: Influence of CYP2A6 genotype on disposition kinetics of nicotine," PM 2063595310.

A collection of gene variants ("alleles") of a gene called Cytochrome P4502A6 affects both nicotine metabolism and activates pre-carcinogens (see Oscarson, M, etal. FEBS Letters 1999; 448:105-10). The suggestion has been made that the gene or its variants might predispose or protect both the desire to smoke and the susceptibility to lung cancer. Here a proposal to study kinetics of nicotine metabolism in 400 volunteer smokers to correlate metabolism of injected nicotine with different gene variants among the subjects. One researcher suggested for the work is Gerhard Scherer of the Verband laboratory in Munich (formerly Franz Adlkofer’s laboratory).

24 September 1998, minutes by Reif (inferred), "Meeting of the Scientific Commission (WPA) of the German Cigarette Association (VDC)...abbreviated report...." PM 2063664420.

The Verband realizes that outsiders now have access to their reports and deliberations:

The exhaustive publication of all types of VdC documents on the internet by US tobacco companies created a violation of personal rights of some of the academic researchers sponsored by the VdC. A task force within the VdC is preparing a complete report on the types of internet documents, their importance, and their inter-relation to each other. In order to avoid similar actions in the future, several options for the internal VdC correspondence and information of member companies will be tested.

But the Verband will carry on: "In a subsequent meeting, the activities of the VdC in the analysis of GM tobacco were discussed."