Report on the Inquiry Conducted on the Ragnar Rylander Affair

Geneva, September 6, 2004

1 Summary……………………………………………………………………………………..3 1. Introduction……………………………………………………………………………….6 1.1. Current Status of the Issue…………………………………………………….6 1.2. Specific Nature of the Inquiry………………………………………………….7 2. The Inquiry and Documentation………………………………………………………9 3. Findings………………………………………………………………………………….11 3.1. Links between Prof Rylander and Industry…………………………………12 3.1.1. Ragnar Rylander worked secretly for the tobacco industry as of the 1960s, rendering a wide variety of services……………………………..12 3.1.2. Ragnar Rylander concealed his links with the tobacco industry in order to give his scientific activity an appearance of independence……13 3.2 A Scientist Under Influence……………………………………………………14 3.2.1. The “Rylander Symposia”………………………………………………14 3.2.2 The report of the Environmental Protection Agency on passive smoking and Ragnar Rylander’s role in the tobacco industry’s reaction……………………………………………………………………………18 3.2.3. Ragnar Rylander’s Chinese connections and the TI’s Asian policy…………………………………………………………………………….20 3.3. Study on the dietary habits of no-smoking women living with smokers or non-smokers………………………………………………………21 4. Conclusions……………………………………………………………………………21 5. Prof Rylander’s Defense……………………………………………………………..26 6. Recommendations……………………………………………………………………..27

2 Summary A Fact-Finding Commission was set up by the delegate for integrity issues of our Faculty pursuant to guidelines drawn up by the Swiss Academy for Medical Sciences. This Commission conducted an inquiry regarding an alleged lack of scientific integrity by Professor Ragnar Rylander, an associate professor at the Faculty of Medicine, within the framework of a defamation suit he had filed against M Pascal Diethelm and Dr Jean-Charles Rielle. It should be recalled that the Cour de Justice (Court of Appeal) had ruled in its December 15,2003 decision that Mr Diethelm and Mr Rielle had proved their claims against Professor Rylander and that the respondent’s motion was dismissed.

On the basis of the inquiry, this Commission has reached the following conclusions concerning the research and consulting work carried out by Professor Rylander on the effects of passive smoking.

Professor Rylander cannot be considered to be an independent researcher vis-à-vis the tobacco industry as he maintained longstanding and largely secret ties as a consultant in the industry. Many documents show that Professor Rylander rarely took initiatives in this area without actively consulting his counterparts in the tobacco industry in particular those at Philip Morris. Not only did this involve scientists in the employ of Philip Morris but also counsel at a law office defending the industry’s interests.

The epidemiological studies on passive smoking by Professor Rylander were carried out in response to initiatives taken by the tobacco industry, which hoped that the studies would generate scepticism over the effects of passive smoking, in line with a strategy adopted by the industry.

Moreover Ragnar Rylander worked as an agent subsidized by the industry and not as an independent researcher in the following domains: As a specialist, i.e. for the American Environment Protection Agency; As an organizer of scientific meetings on the theme of passive smoking; As a representative of Philip Morris for laboratories conducting partially secret research on passive smoking; As an influential agent at a university (the University of Hong Kong) invited to confer an important promotion on a researcher who herself was working for the tobacco industry, so as to give the tobacco industry a springboard in Asia.

It should be noted: That at no time did the Commission fault Professor Rylander for his opinions such as they were nor for the fact that he had accepted financing for his research from the tobacco industry. That the Commission made no judgement concerning any activities of Professor Rylander’s that were unrelated to the issue of tobacco.

3

On the other hand, the Commission believes that concealing the true scope of the dependence on the tobacco industry and aligning his activities as a researcher and specialist in the areas of tobacco smoke with the strategic objectives of the industry constitutes an infringement of the scientific integrity that the general public and his peers were entitled to expect from a university researcher. The Commission believes it is incumbent upon it to propose compensation for harm caused by breaches to scientific integrity by Professor Rylander, and above all to prevent repetition of such infringement. Toward this end, the Commission proposes the five following measures:

1-The Scientific community and the public-at-large should be informed that Ragnar Rylander’s work on the effects of environmental smoke on health have been cast under serious suspicion since the researcher did not disclose any conflict of interest likely to influence the scope of his work and that given the role he played as a secret employee of the tobacco industry, he cannot be held to be an independent scientist. The Fact-Finding Commission proposes to send written notification of this to the following journals: -European Journal of Public Health -Archives of Environmental Health -International Journal of Epidemiology

2-The impact of Professor Rylander’s lack of scientific integrity can only be fully understood within the context of the strategy designed and undertaken by the tobacco industry to create doubt as to the toxicity of smoke, in particular for non- smokers. Although this is an individual case we should not overlook the fact that the most unpardonable guilt results from the institutional and commercial power of the tobacco industry whose objectives and interests clash with those of both public health and medical science. The copious documentation stemming from the tobacco industry, made public through rulings against the industry in American courts shows that these companies tried to manipulate public opinion for decades and that the targeted involvement of many scientists has been a useful instrument in this endeavour to disseminate misinformation . The tobacco industry cannot be considered a credible partner of independent scientific research. The Commission proposes that henceforth, members of the University be prohibited from requesting, directly or indirectly, research grants or consultancy contracts from the tobacco industry. This measure is designed to protect the scientific integrity of researchers.

3-Given the current context, this prohibition probably will have mainly a symbolic impact. The Commission wishes to ensure that its recommendations measure up to the challenges before us in the future and thus proposes that the Faculty and the University engage in thoughtful reflection on links between university research and the private sector. Private financing of biomedical research is an inevitable fact of life for therapeutic innovation, particularly regarding the pharmaceutical sector.

4 This is nothing new; moreover, such partnerships are necessary for new therapies to be developed. Nevertheless the very nature of the bonds between industry and academic research are undergoing deep-rooted changes. We have moved from two distinct worlds that followed their own rules to one where an increasingly close interlinkage prevails, due, in particular, to the need to give monetary value to scientific knowledge. The question that the entire university community must now urgently address is: how these partnerships can be organized in a mutually beneficial manner, consistent with the university’s primary mission, that is, a disinterested quest for scientific knowledge. The Commission urges university authorities to take proactive measures to anticipate and control developments in this domain.

4- A lack of vigilance at the time facilitated the serious infringements to scientific integrity for which Ragnar Rylander is held accountable. The Commission wishes all members of the University to be reminded of the rules that will henceforth be applied concerning transparency and disclosure of conflicts of interests that must govern their relations with the University, university departments, financing entities for research, and scientific journals. Furthermore, challenges to scientific integrity are constantly changing and the University must be able to keep up with these changes and adapt. When the need for new rules arises, they must be designed with and accompanied by penalties in case of breaches. Moreover, University, faculty, and departmental management must be kept abreast of accessory activities (consultantships, involvement with commercial enterprises) by members of the faculty and staff and that standards for curriculum vitae must reflect this demand. This also holds true for associate professorships, a post which has proved its worth in bringing in outside talent to university but which should not lead to any administrative laxity.

5- The Commission wishes information and specific training to be organized for young researchers, to empower them to practice their profession clear-sightedly so they can act as knowing collaborators with industry with discernment. The Commission proposes that the Rectorate and Deans organize a consultation on how this should be carried out. This would be a continuation of the work currently in the pipeline by the Rectorate to disseminate guidelines on scientific integrity to all faculties. These guidelines should be taught in a specific educational context involving practicing researchers and other specialists.

Since Rylander has retired and administrative liability is time-barred1, we have not been called upon in this report to propose disciplinary measures.

1 Conclusions and measures of the Rectorate (6 November 2001, § 1.2

5 In-depth Report

Introduction

Current status of the issue2 In this report “the tobacco industry” (hereafter known as TI) shall be defined as the group of commercial enterprises engaged in the sale of cigarettes. In the case before us, these enterprises are essentially Anglo-American companies which have forged certain strategic alliances, revealed during litigation in the United States. The litigation led to agreements obliging the companies at issue to make a large number of confidential documents available on the Internet.

The term “passive smoking” shall hereafter be used to define exposure of a third party to smoke emitted into the air by a smoker.

This Commission was set up in the summer of 20033 in a context marked by ongoing court action that terminated with the December 15, 2003 decision by the Cour de Justice (Court of Appeal) The fact that court action was underway did not release the University from its obligation to conduct an inquiry on allegations concerning Professor Rylander, as these claims concerned the code of ethics followed by the researcher for which the academic institution acts as guarantor.

In fact, the responsible exercise of the freedom to conduct research is above all a matter concerning researchers themselves and their institutions. This implies they have the right and the duty to judge those who break deontological rules in science. Moreover, experience has proven that such breaches do not necessary constitute misconduct and are often overlooked by the legal system. The ruling of the criminal division of the court of cassation in the Ragnar Rylander case notes, furthermore, that “scientific fraud is not a notion that falls under the jurisdiction of federal law”4 This places scientific activity in a very general normative framework, relating principally from that of the freedom to conduct research.5

From the outset significant differences appeared between the case now before us and cases of scientific fraud which have hit the headlines in Geneva and elsewhere. In such incidents it was often a collaborator of the accused who suspected that the

2 Documents resulting from litigation against the tobacco industry in the United States and published on the Web on the basis of agreements between States and industry are referenced according to a number or a single alphanumeric sequence called the Bates number”. This is the identifier used in this report which allows corresponding documents to be located on Internet sites such as Tobacco Documents Online(http://tobaccodocuments.org/) or industry data bases. Documents referenced as “AH” 3 Pursuant to the guidelines of the Swiss Academy of Medical Sciences on scientific integrity,§ 4.2.3. 4 Criminal division of the court of cassation,17 April 2003 ruling. 5 Freedom to engage in research and teaching is guaranteed by art. 20 of the Swiss Federal Constitution and by several federal and cantonal law, cf Auer A, Malinverni G, and Hottelier M Droit Constitutionnel Suisse, vol II. Bern: Staempfli (2000),§559ss

6 experiments were being manipulated or a careful reader of a scientific publication who discovered evidence of falsification in the report of a supposedly spectacular discovery. In this case Philip Morris was legally bound to make public a large number of secret documents that provided the substance for the initial inquiry. The inquiry revealed, in particular, the scope and longstanding nature of the ties between Prof Rylander and the TI. Later, it was paradoxically the appeal lodged by Prof Rylander against the whistleblowers that heightened the gravity of his case, as many testimonies confirmed.

Even before the case became a matter of notoriety in Geneva Prof Rylander’s ties with the TI had been questioned and called into question by the scientific press.6The claims made against Ragnar Rylander should be placed in context: an extremely broad operation was being carried out by the TI to conceal the harmful effects of their products, and in particular of passive smoking. For although it was impossible to deny the deleterious effects on health of direct smoking the TI7 had adopted a new line of defense based on the idea that smoking was a matter of personal choice, made by smokers with full knowledge of the facts. Data showing that smoking was equally harmful to non-smokers8 jeopardized the very existence of the TI since the data removed all credibility from the argument based on free choice. This opened the door to a much more stringent banning of smoking in public places. It became of utmost strategic importance9 to deny that passive smoking was harmful or at the very least to challenge the charge. This was done by means of studies initiated by the industry to demonstrate that secondary smoke was harmless. The TI allocated significant financial and human resources to this task. 10 It encouraged researchers to take positions and publish results minimizing the risks of passive smoking, and if possible, to do so under cover of an alleged scientific independence. 11 The Cour de Justice recognized this manipulation when, in its second decision of December 15, 2003, it acknowledged that the expression “unprecedented fraud” used by the appellants against Ragnar Ryland did not constitute defamation.12

1.2 Specific Nature of the Inquiry

6 Ong EK, and Glantz SA. Constructing “Sound Science” and “Good Epidemiology”: Tobacco, Lawyers, and Public Relations Firms. Am J Public Health 2001;91:1749-57. 7 In the 70s cigarette manufacturers had sought to face up to their adversaries by means of a mutuel secret agreement (known as Operation Berkshire) to not give way when faced with evidence on the harmfulness of direct smoking. Whereas this unanimity was quickly broken by the company British American Tobacco, it lead to the coordination of a number of propaganda campaigns between national associations and tobacco manufacturers 8 Hirayama T. Non smoking wives of heavy smokers have a higher risk of lung cancer: a study from Japan. BMJ 1981; 282:183-5. 9 Hong M and Bero L. How the tobacco industry responded to an influential study of the health effects of secondhand smoke. BMJ 2002; 325:1413-6. 10 Yach D. and Bialous SA. Junking Science to Promote Tobacco. Am J Public Health 2001;91:1745- 8. 11 Thompson’s Memorandum to Kloepfer, 18 October 1968, TIMN 0071488 12 Decision of the Cour de Justice,, in its 15 December 2003 hearing.

7 Since the Cour de Justice‘s December 15, 2003 ruling dismissed the case brought by Prof Rylander who did not appeal the ruling before the Federal Tribunal, it should be considered that the judicial part of the case is over and that the courts have recognized the veracity of the accusations levelled against Ragnar Rylander. It should be recalled that there are three accusations: 1-Ragnar Rylander “had been secretly employed by a cigarette manufacturer”; 2-Rangnar Rylander was “one of the most highly paid consultants” of this manufacturer; 3--Ragnar Rylander’s activities correspond to “unprecedented scientific fraud”. The Court notes that this term designates the double game Ragnar Rylander played when, on the one hand he presented himself as an independent researcher yet, » on the other hand, as a collaborator working for an industry whose interests have always been opposed to those of public health”. The term scientific fraud is not used in reference the modifications made to the basic data in Ragnar Rylander and Ysabelle Mégevand’s study on the risks of passive smoking to children. This change was brought up at great length during the trial and shows the influence that Ragnar Rylander’s main scientific contact person (T Osdene) had at Philip Morris but it is impossible to prove that this led to “fabricated research results” or “intentional falsification of basic data” in accordance with paragraph 3.3 of the Swiss Academy of Medical Sciences (ASSM) directives.

The task before our Commission was to re-examine the evidence that had already been collected during the four trials involving the “affair” and to verify with Professor Rylander that no other evidence existed. This review was not legal in nature- legal matters fall under the jurisdiction of the courts- but rather one concerning deontology; its aim was to establish if the standards of university scientific honesty had been flouted. Such standards are implicit in any academic research worthy of its name and are essential for its success. These standards cover accuracy and objectivity in obtaining research results; evaluation and publication of the results. Furthermore, a scientific publication should, insofar as is possible, allow the scientific community to make a precise assessment concerning the value of the author’s work to the body of scientific knowledge. This necessarily involves revealing any potential conflict of interests.

In the field of biomedics, the ethical code is becoming increasingly codified in the form of normative texts, such as the guidelines of the Swiss Academy of Medical Sciences13 of the Council for International Organizations of Medical Sciences (CIOMS)14 or from editors of medical journals15. These guidelines clearly define norms which traditionally were considered to be automatically applied in the scientific community. It would be advisable, therefore, to remain aware that these norms are constantly developing, particularly those concerning collaboration between academic

13 Integrity in Science. Swiss Academy of Medical Sciences guidelines concerning scientific integrity in medical and biomedical research and procedures for handling fraud (June 2002) http://www.samw.ch/content/Dokumente/f_CIS_RL.pdf (.11. 7.2003). 14 1991 International Guidelines for Review of Epidemiological Studies. http://www.cioms.ch/frame_1991_texts_of_guidelines.htm (11.7.2003). 15 Uniform Requirements for Manuscripts Submitted to Biomedical Journals (The Vancouver guidelines). Ann Intern Med. 1997; 126:36-37.

8 researchers and industry, so as to avoid judging events that may have taken place in the past according to current criteria. This was borne in mind when R’s controversial activities were evaluated. Regarding other deontological issues, for example honesty and candor in scientific communication, recent codifications now reflect the synthesis of ethical values enshrined through long usage, as they constitute an integral part of scientific activity.

2. The Inquiry and Documentation

The inquiry was conducted on the basis of the following documents:

- Documents submitted to the Commission by M Pascal Diethelm and Dr Jean- Charles Rielle; - Documents submitted to the President of the Commission for consideration by Professor André Rougemont; - Documents submitted to the President of the Commission for consideration by Vice-Rector Peter Suter; - Communications sent to Professor Martin McKee (London), Staffan Edén (Göteborg), Anthony Hedley (Hong Kong), as well as the documentation M Hedley submitted to Professor Mauron. - The manuscript of an article by P Diethelm, JC Rielle and M McKee accepted for publication in the British journal The Lancet. - -Professor Mauron’s interviews with: 1. Professor Theodore Abelin, honorary professor at the University of Bern 2. Professor André Rougemont, director of the Institute for Social and Preventive Medicine 3. Professor Olivier Jeanneret, former director of the Institute for Social and Preventive Medicine (by telephone) 4. Vice-Rector Peter Suter (former Dean of our Faculty), who submitted to Professor Mauron certain documents conserved at the Rectorate 5. Ms Ysabelle Mégevand, former collaborator of Professor Rylander , as well as her letter to Professor Mauron, 6. Ms Marie-Claire Snella, former collaborator of Professor Rylander and the letter she had sent him. 7. Mr Jean-Pierrre Etter, collaborator at the Institute for Social and Preventive Medicine.

Our Commission heard the testimonies of Mr Rielle and Mr Diethelm, who gave the Commission the documentation they had collected in order to back up their allegations. The Commission had notified them beforehand of the four axes of discussion that they particularly wished to look into, and these themes acted as a red thread in the in-depth discussion on evidence presented. In this manner the Commission particularly wished to examine documents which:

1) would establish a contractual link between Ragnar Rylander and the TI and its subsidiaries (INBIFO, Fabriques de Tabac Réunies) including the type of services provided, functional links, amounts paid, etc.; 2) would document the possibly active role played by Ragnar Rylander in forging the TI’s strategy(not simply carrying out orders) and would allow an evaluation to be

9 made of how important a role Ragnar Rylander played in comparison with other scientists similarly implicated; 3) would document communication between Ragnar Rylander and the industry concerning the analysis and interpretation of studies carried out by Ragnar Rylander, before their publication; 4) would cast light on the intent to conceal the links between Ragnar Rylander and the industry; 5) Any other pertinent document naming or implicating Ragnar Rylander directly.

Moreover, certain information in the medical press, including recently, has led to important additional input.

Professor Rylander was invited to give his point of view on the case by letter on November 25, 2003. In a telephone conversation with Professor Mauron on December 17, 2003 he offered to send a written response to the questions raised in the letter and expressed his willingness to be heard before the Commission. His response to the claims made by the Commission are contained in a letter dated January 26, 2004, which served as a basis for Prof Rylander’s hearing before the Commission. The hearing took place at the Deans’ Office at the Faculty of Medicine on March 16, 2004 between 2 and 4:45 p.m. Professor Rylander had the opportunity to express his views concerning the claims made against him. In the aftermath of the hearing Professor Rylander followed up with a letter (dated March 23, 2004) contesting the charges made against him.

The documents collected by Professor André Rougemont and those submitted by Vice-Rector Peter Suter recount the different stages of the case as of the moment Professor Rylander filed suit against Mr Pascal Diethelm and Dr Jean-Charles Rielle. They also include documents concerning the inquiry by the three deans, the Rectorate’s conclusions as well as Professor Timothy Harding’s report. No new elements came to light in these documents beyond those revealed in the litigation, with one exception: the curriculum vitae Professor Rylander had given the administration. While he enumerates several posts as specialist and advisor, nothing is said in these documents pertaining to his ties with the TI.

8. Interviews with Professors Jeanneret and Rougemont, as well as with Dr Jean- François Etter reveal that Ragnar Rylander had a very good reputation as a productive researcher and an appreciated teacher. His personal charisma and the influence he had on those who worked with him helped give him great freedom of action at the Institute for Social and Preventive Medicine (IMSP) especially given that it was not his primary affiliation. His ability to draw outside financing was known but valued, given the modest resources available in preventive medicine. The origin of the funding obtained by Ragnar Rylander does not seem to have been challenged at the IMSP, except for a heated discussion instigated by Mr Jean-Pierre Etter which many of his collaborators recall, but which had no consequences. According to Jean-Pierre Etter, Ragnar Rylander denied at the time having received financing from the TI for his studies but gave the name of an American Foundation (according to Professor Rylander it was the Center for Indoor Air Research). It seems difficult to reconstitute the exact breadth of the information concerning the type of links between Ragnar Rylander and Philip Morris that was available to the different members of IMSP at the time. Interviews

10 with Ms Mégevand and Ms Snella did not provide new information for the inquiry. In their view Ragnar Rylander did not conceal the fact that he had dealings with the TI.

From the beginning of his career on, Professor Théodore Abelin had been interested in the TI’s influence on certain researchers. Over the years he had gathered a great deal of documentation in this regard. At the 1983 Symposium organized in Geneva by Ragnar Rylander he alerted Professor Olivier Jeanneret to the origin of the funding. During his interview with Professor Mauron, Professor Abelin made special mention of his analysis of an article Ragnar Rylander had published in The International Journal of Epidemiology16, which was also brought up during his testimony at the Tribunal de police (a criminal court of first instance). In the article, Ragnar Rylander commented upon a study which he felt suggested that in certain ethnic groups women who smoke a small number of cigarettes per day might have a lower risk of lung cancer than non-smoking women. Whereas, on the basis of a statistical test that Ragnar Rylander was necessarily aware of, this result was not significant. Moreover, Professor Abelin believes that Ragnar Rylander knowingly concealed certain published scientific data that tended to refute the position that nutrition was a confounding factor in studies on the harmful effects of passive smoking.

Professor Anthony Hedley’s initiative from Hong Kong in establishing contacts with the Rectorate at the University of Geneva provided further information. Professor Hedley had been informed of the legal suit Ragnar Rylander had filed and had communicated the documents to the Rector which implicated Ragnar Rylander in an attempt to infiltrate the Hong Kong Faculty of Medicine on Philip Morris’ behalf in 1989. Professor Hedley was put in contact with Professor Mauron and transmitted the information in his possession, as seen in the commentary in Chapter 3.2.3.

The most important source on which the Commission based its work was the extremely large number of documents found by Mr Dielthelm and Mr Rielle on TI data bases, as well as additional information by Professor Hedley. The Commission has endeavoured to make an independent and objective interpretation of all this information which cannot be deemed to be second-hand. In fact these documents are originals that are direct links with Ragnar Rylander: they were sent by or to him or they come from major players in the TI and cast light on Ragnar Rylander’s position in relation to industry consultants.

3. Findings

Our study of the collected documentation has been organized according to three thematic axes. We shall firstly analyze the nature of the ties between Ragnar Rylander and the TI and then the effects these ties have on Ragnar Rylander’s research and consulting activities in his interactions with the scientific community and journals. Lastly we shall focus on doubts cast as to the validity of Ragnar Rylander’s scientific work on passive smoking.

16 Rylander R. Environmental Exposures with Decreased Risks for Lung Cancer. Int J Epidemiology 1990; 19/3 suppl1: S67-S72.

11 3.1. Ties between Professor Rylander and the TI

3.1.1. Ragnar Rylander worked secretly for the tobacco industry as of the 1960s, rendering a wide variety of services.

This contractual relationship has been abundantly documented, starting above all from the consulting contract dated December 7, 1972 which links him to Philip Morris via INBIFO (Institut für Biologische Forschung), a research institute in Cologne belonging to Philip Morris17. It turns out that the part-time positions held by Ragnar Rylander he was at first research supervisor (chargé de recherche), then guest professor, and lastly associate professor) were all linked to the possibility of being a consultant for Philip Morris. The financial aspect of this association appears from the outset in Ragnar Rylander’s correspondence with Tom Osdene, a principal scientist at Philip Morris:

“I am still in the process of analyzing the possibilities to move to Geneva and several practical problems there have been solved. A main problem at the time is the financial situation as the salary, which I will be offered is considerably less than my present here in Stockholm. It will thus be necessary for me to obtain consultantships and I was glad to know from the conversation we had over the telephone that our present joint work can also be performed under the terms of a consultantship.”18

The confidential conversations between H Wakeham, research director at Philip Morris and T Osdene defined Ragnar Rylander’s initial obligations to Philip Morris. Ragnar Rylander was to be Philip Morris’ representative at INBIFO and he would be obliged to be physically present 3 days a month in Cologne. Officially Ragnar Rylander was to be paid by the Fabriques de Tabac Réunies (Neuchâtel) but in actual fact Ragnar Rylander would supervise Philip Morris’ projects at INBIFO19 20Furthermore an exclusivity clause compelled Ragnar Rylander to end his former contractual relationship with the company Lorillard (another cigarette manufacturer).21

Philip Morris M had purchased INBIFO through its Neuchâtel subsidiary, Fabriques de Tabac Réunies, to conduct toxicological research on tobacco with a degree of confidentiality that would be impossible in the United States. The links between Philip Morris and Ragnar Rylander were part of an intricate web woven to keep the TI’s financing of researching on smoking at INBIFO under wraps as far as possible, and Ragnar Rylander was used as a representative and influential agent. Many documents show the permanence of this link between Philip Morris and Ragnar Rylander was during the 1980s 2223 and again in 199524, in 199725 and in 200226. Corresponding payment

17 Contract dated 12.7.1972, 2081912524 18 Rylander’s letter to Osdene, 7.19.1972, 2501367907 19 Wakeham’s Memorandum to Osdene 28.7.1972,1000259869/70. Also see Wakeham’s Memorandum to Osdene, 9.18.1972,2501370551/4. 20 Osdene’s Memorandum to Wakeham, 9.18.1972,2501370551/4 21 Rylander’s letter to Spears, 12.11.1972,01252244. 22 Consultant budget 1980-1984, 2015054704 23 Science and technology budget for consultant 1986-1989, 2001202325 24 INBIFO Inspection Report, 2050754433 25 Carchman’s Memorandum to Banty, 7.10.97, 2063590979

12 for this position was high and distinct from the amounts that Ragnar Rylander received as funding for work done at his laboratory 2728 This last document also shows that Ragnar Rylander’s consulting fees were paid independently of any confidential tasks set by Philip Morris, at least during a particular period. Later, Philip Morris set up more specific accounting categories which in any case showed the diversity of jobs he had done for his secret employer,29 services and commentaries on passive smoking to public entities, organization of colloquia, training courses in “Good Epidemiological Practice”, particularly in China,3031 and his leading role at INBIFO where he was called upon to countersign a large number of bills for a variety of the institute’s expenditures.32

Although he initially denied it, Ragnar Rylander no longer gainsays having received large sums of money from Philip Morris over the years, but claims they were allocated to his research. These statements have been belied by accounting documents which, year after year, have shown amounts budgeted under the heading of consultants’ fees. 33 Moreover, it has come out from an inquiry carried out by Professor Martin McKee (editor of The European Journal of Public Health) that Ragnar Rylander lied when stating that his sole links with the TI were with Philip Morris (which were impossible to hide due to the overwhelming documentation providing evidence). In fact he had hidden his former connections with other players in the TI for whom he had already worked in Sweden, namely the company Lorillard and the Kansas City law office of Shook, Hardy and Bacon.

3.1.2. Ragnar Rylander Concealed his Links with the Tobacco Industry in order to Give his Scientific Activity an Appearance of Independence

His employment contract included a secrecy clause, which, at first sight, is not unusual in a consulting contract (so as to safeguard intellectual property from the contracting company, for example). Notwithstanding, this secret also allowed a cover up of the nature of the ties between Ragnar Rylander and Philip Morris. Ragnar Rylander gave an explanation in a letter dated June 23, 1997, where he denied the likelihood of any negligence in maintaining confidentiality.

« Throughout the years I have always been very strict to report to Richmond only and particularly not get engaged in the activities of the Neuchâtel group. Also regarding specific projects, I have also adhered uniquely to Richmond

26 Tribunal de Police, 4-9.2002 hearing 27 Carchman Memorandum to Banty .7.10 97, 2063590979 28 Memorandum Philip Morris Corporate Scientific Affairs, undatd, 2023223287/90 29 Rylander Letter to Banty , 8.9.1997, 2063590558. 30 R. Carchman Memorandum to T. Banty, 7.10.1997, 2063590979/80 31 Ragnar Rylander did his training in toxicology,and studied epidemiology belatedly. He played a significant role in setting up a scientific disinformation campaign staged by the TI aiming to establish a pseudo-quality control in this science, more further on 32 NBIFO expenditures authorized by Ragnar Rylander for the year 1989 amounted to more than 12 million deutsche mark. Cf invoices 2021614760/1, 2021614777/8, 2021614795/804, 2021614806/811, 2021614957/960. 33 cf. for example 2001202324/5

13 and to CIAR. Finally, I have never been involved with any Philip Morris executive in meetings or contacts with outside persons, to retain as far as possible the image as an independent scientist”.34

Ragnar Rylander was clear: he never appeared in public with anyone who could be associated with Philip Morris so that, as he put it, his image as an independent scientist could be maintained as far as possible. Our conclusions dovetail with those of the Cour de Justice in its 1.13.2003 decision wherein it acknowledged that Mr Dielthelm and Mr Rielle’s allegations that Ragnar Rylander had been “secretly employed by Philip Morris” were well-founded.

Testimony by a former Philip Morris employee show that the INBIFO operation and the Rylander-Osdene network were dealt with in the greatest secrecy within Philip Morris itself and that most of top management remained unaware of the very existence of the network. 35 Other evidence shows how diligently the secret about links between Philip Morris and INBIFO was kept36. The secret protected INBIFO’s unpublished work whereas the high-profile part of the work of that institute, published in scientific journals, basically aimed at challenging the idea that passive smoking was harmful. The testimony of William Farone, former director of applied research at Philip Morris, corroborates the fact that the link between passive smoking and cancer was known to the TI as of the 1960s, as was the well-kept shroud of secrecy surrounding communication of INBIFO’s research results, a secrecy which Ragnar Rylander and T Osdene were implicated in cultivating. 37

As the following examples show, Ragnar Rylander’s services for the TI go beyond scientific expertise and commissioning of research; they correspond in fact to on- going expertise provided to Philip Morris. To be more effective Ragnar Rylander had to hide the true nature of his links under the image of an independent academic researcher who enjoyed a certain renown in his field.

3.2 A Scientist Under Influence

3.2.1. The “Rylander Symposia”

Documents concerning Ragnar Rylander’s relations with the TI clearly indicate that Ragnar Rylander was considered to be a high-level employee of Philip Morris and not a occasional consultant, that he intentionally contributed to the industry’s strategy by denying the impact passive smoking had on health, or at least by deliberately sowing doubt in people’s minds. The symposia that he organized in close collaboration with Philip Morris and other TI companies, underscore this point. In this way, in 1973 Ragnar Rylander suggested to his Philip Morris contact that he should organize a symposium on the effects of smoking on non-smokers.38Philip Morris

34 Letter from Rylander to Carchman , 6. 23..97, 2063590609. Philip Morris’ headquarters are in Richmond (Virginia) whereas the (Neuchâtel group » corresponds to Fabriques de Tabac Réunies, a subsidiary of Philip Morris that paid Ragnar Rylander. CIAR is a front name for the TI and will be explored further on. 35 Statement Uydess, 2063121841/65. 36 R. Seligman’s letter to Dr Max Hausermann dated 31 mars 1977, 2000512794/5. 37 Cour de justice, hearing, 8.26..2002. 38 Rylander to Osdene, 7.6.1973, 2501373517

14 accepted this proposal for a symposium (which was to be held in March 1974) and proposed immediately to give a $30,000 grant to the University of Geneva through the FTR (Fabriques de Tabac Réunies) .39.Moreover Philip Morris put Ragnar Rylander in contact with an attorney mandated by the TI in the hope that Ragnar Rylander would convince him of the usefulness of such a symposium in bolstering the thesis of the harmlessness of passive smoking.40When challenged by a researcher, Dr William Dublin, who highlighted the risks passive smoking entailed for children41, Ragnar Rylander immediately turned to his usual correspondent at the law offices of Shook, Hardy and Bacon42. Ragnar Rylander’s correspondence with his backers basically shows the will to adopt a tactic of neutralizing those who contradict him however, without appearing one-sided. The symposium‘s objective was, in the words of the research director of Philip Morris, H.Wakeham, to come out with “a document we can use to quiet some of the hysteria on the subject” (the subject being passive smoking),43 and was organized in line with the company’s clear instructions. The final report of the symposium, intended for publication in the journal Science (but which Science turned down for publication) was written under the direct influence of Philip Morris’ collaborators and attorneys. H Wakeham described the drafting process as follows:

«The draft has been prepared by Nick Fina at the Philip Morris Research Center as a ghost writer and is intended to be published over the name of Ragnar Rylander44

Another Philip Morris researcher even suggested adding, verbatim, a paragraph absolving environmental smoke and carbon monoxide45. Ragnar Rylander was not opposed to this on substantive grounds yet he deemed it to be imprudent since it might make other participants in the symposium suspicious. 46 The final symposium report47 was used as propaganda by Philip Morris to denigrate its adversaries. Thus, for example, in a letter H Wakeham wrote to Ernest Conine of The Los Angeles Times, Ragnar Rylander’s report was cited in full as a rebuttal to concerns by anti- tobacco “busybodies”:

« …that the risk for the development of chronic pulmonary effects due to environmental tobacco smoke exposure is non-existent among the population in general ».48

Ragnar Rylander’s views, moreover, were reflected in other propagandist texts of the same ilk. 4950 It should be noted that in 2001, after the University of Geneva adopted

39 Wakeham letter to Hauserman, 9.12.1973, 1000257859 40 Wakeham letter to Rylander, 8.10. 1973, 1001813013 41 Dublin letter to Rylander, 10.1.1973,2015035616 42 Rylander’s letter to Hoel,.10.5.1973, 2015035615. 43 Wakeham’s letter to Bentley,.2.26..1974, 1004864214. 44 Wakeham’s letter to Hoel, Holtzman, for the attention of Rylander, .8.16.74, 1004863825 45 Anonymous note dated 1974, 1000260194/5. 46 Rylander’s letter to Fagan,10.3.1974, 1000260180/1. 47 Rylander, Scientific Report ,undated, 1000260165/179 48 Wakeham’s letter to Conine , of the Los Angeles Times, 8.8.77, 1000217977 49 BBDO « Who says it’s never been shown smoke causes disease in non-smokers? These scientists say so.” 500008296/7. 50. Do you mind if I smoke ? ». Advertisement in Australian Media, 532000342

15 its position on his affair for the first time, Ragnar Rylander purely and simply denied that the stance he had taken had favourably positioned the TI and he requested that this matter be looked into further:

“..the Rectorate has requested that I and my colleague publicly disassociate ourselves from the tendentious use of our research by the TI. Given that we have not been informed of how it is being used I would kindly request to clarify the criteria used by the report in arriving at such a conclusion and to send me examples, statements and publications that will allow us to respond.”51

In fact, the “tendentious use” made of the Bermuda Symposium proved successful for the TI. A second “Rylander symposium” was organized in 1983, this time in Geneva. There again, the influence of Philip Morris and its attorneys was decisive in designing the project, aiming to avoid giving a platform to TI opponents. The state of affairs had actually changed in scientific terms. In 1980, a study conducted by JR White and HF Froeb on the pulmonary functions of passive smokers52 raised concerns within the TI as seen in a confidential note by a Philip Morris collaborator to T. Osdene, who found the article to be otherwise “excellent”:

«I have reviewed the above paper and find it to be an excellent piece of work which could be very damaging to our business. (…) This is not a question that can be answered by anyone inside the tobacco industry. Even if one could answer such a question a rebuttal by the industry would have little impact. What is needed is an independent evaluation of the paper by members of the medical profession. I suggest that Ragnar Rylander be asked to review the paper and make the necessary contacts to define the real significance of the paper. 53

The author continued by suggesting that Ragnar Rylander, shortly to attend a colloquium on thoracic medicine, be contacted. Philip Morris hammered out a rebuttal strategy regarding the White and Froeb article which was to be on a vast scale since it included lobbying Congress in the US by means of a congressman who was sympathetic to TI positions.54 More scientific data that was dangerous for the TI emerged from the work of Takeshi Hirayama on the association between lung cancer and passive smoking in non-smoking wives of smokers in Japan.55 The TI countered with concurrent studies whose aim was to disprove this association,56 and other events that would feed the controversy.

51 Rylander’s letter to Vice-Rector Doelker dated 12.12.2001. 52 52 White JR and Froeb HF. Small-Airways Dysfunction in Nonsmokers Chronically Exposed to Tobacco Smoke. NEJM 1980; 302:720-3. 53 Memorandum from Charles à Osdene, 3.30.1980, 1002641904/7. 54 Charles Rose, who submitted a memorandum aiming to prevent White et Froeb’s article to be taken into consideration by the American government 1005114242. This operation mobilized several experts favourable to the TI , all of whom were proposed for Rylander’s second symposium. 55 Hirayama T. Non-smoking wives of heavy smokers have a higher risk of lung cancer. BMJ 1981;283:1464-6. 56 Hong, MK, and Bero LA. How the tobacco industry responded to an influential study of the health effects of second hand smoke. BMJ 2002;325:1413-6.

16 The law office of Shook Hardy Bacon contacted Ragnar Rylander to suggest the Bermuda symposium be repeated.57 This idea was supported by other TI-related entities, namely Lorillard58 and the Tobacco Institute59 (a front group for the TI). Ragnar Rylander accepted and noted that what mattered was to foster and sustain doubts about the harm caused by second-hand smoke:

« His (Rylander’s) major point was that he did not feel that the workshop could or would be in a position to give environmental smoke a “clean bill of health.” However, Dr. Rylander did believe that he could bring a healthy scepticism to the conference and some of the claims made about environmental tobacco smoke.»60 It would appear that the TI came up against certain difficulties in organizing a second “Rylander symposium”, in particular due to the reservations certain people within Philip Morris had about the planned participation of “adversaries” such as Garfinkel, the American Cancer Society epidemiologist, and Hiramaya, the Japanese epidemiologist both in charge of cohorts on the health effects of active and passive tobacco exposure.61 The problem was, nonetheless, finally resolved and towards the end of 1982 Donald Hoel (of the law office Shook Hardy and Bacon) wrote to T. Osdene of Philip Morris to laud Ragnar Rylander’s malleability:

«(…) he was very receptive to suggestions. He would not invite Garfinkel, Hirayama, etc.»62

Since the plans for the symposium were finally approved by the TI lawyers, Ragnar Rylander invited the participants to Geneva on behalf of the Universities of Geneva and Göteborg63. The TI was to bear the costs, as seen in a confidential letter by D. Hoel64. Contrary to the latter statements by Ragnar Ryland that financial backing was not problematic at the time and he would never have tried to conceal it, we see as follows that he was concerned about the possible visibility of links between “his” symposium and such financing:

« Dr. Rylander believes that CTR (Center for Tobacco Research) would be an appropriate sponsor. (…) Since CTR is a recognized independent research institution, he feels this source of funding would be much preferable to the Tobacco Institute. In addition, Dr. Rylander pointed out that in various news articles surrounding the Hirayama article the Institute was referred to as the “lobbying arm” of the U.S. tobacco industry. Therefore Dr. Rylander felt that there might be, in some circles, some opinion that money coming from the Institute for such a conference was possibly “tainted.”65

57 Letter from Hoel to Rylander dated 5.2.1980, 2024987064/5. 58 Letter from Stevens to Shinn dated .6.1.1981, 01331069. 59 Memorandum from Kloepfer to Childcote dated 7. 27..1981, TI1004-2072. 60 Mémorandum Hoel du 31.8.1981, 680542958/62. 61 Memorandum from Spears to Judge and Stevens dated 11. 16.1981. 01346187/91 62 Letter from Hoel àto Osdene 1. 27..82, 1000083924/6. 63 Letter from Rylander to Aviado dated 8. 17.1982, 504339388. 64 Memorandum Hoel dated 6. 17.1982, 502122726/7. 65 Mémorandum from D. Hoel, 8.31..1981, 680542958. The organizers ignored Ragnar Rylander advice and the symposium was financed by means of a grant from the Tobacco Institute to the University of Geneva. In the end both institutions were recognized by the courts to be fronts for the TI and dissolved as such, with a prohibition to reform

17 When his links with the TI began to be unravelled Ragnar Rylander claimed that he had resorted to industry funding because he had been unable to interest “traditional research foundations”66 He has, however, never been able to produce any evidence demonstrating that such steps were taken and the available documents show that this symposium was designed and planned from the outset by the TI as a public relations operation.

The TI symposium took place to the satisfaction of the TI although the University of Geneva declined to publish a final communiqué.67 As was the case for the first symposium, the presentation and dissemination of results were closely coordinated by Ragnar Rylander and counsel at Philip Morris. The conclusions in the introduction of Ragnar Rylander’s report are intentionally sceptical about the harmfulness of passive smoking and negate the existence of a serious public health problem. 68 The report was used extensively by the TI vis-à-vis the political authorities69 and press. 70 Reynolds-sponsored advertising cited the title of Ragnar Rylander’s draft of the symposium report.

« An overall evaluation based upon available scientific data leads to the conclusion that an increased risk for non-smokers from ETS exposure has not been established »71

The overall abundant correspondence between Ragnar Rylander and his sponsors shows that, far from being an independent and critical researcher, he willingly followed guidelines from his employer in the industry, all the while leaning on his academic credentials to prop up his credibility in the eyes of the outside world. This particularly held true for the University of Geneva whose framework and structures were used to host the symposium and to disseminate the report to American medical schools, as indicated in a letter by S:D: Chilcote, of the Tobacco Institute.72

3.2.2 The Report of the Environmental Protection Agency on Passive Smoking and Ragnar Rylander’s Role in the Tobacco Industry’s Reaction.

In 1990 The U.S. Environmental Protection Agency (EPA) published a report on the effects of passive smoking that alarmed the TI. On the basis of a review of epidemiological data available at the time the EPA concluded there was a causal relationship between passive smoking and lung cancer in adults as well as in children’s exposure to environmental smoke and various respiratory pathologies.73 The TI reacted by presenting comments by so-called independent experts to discredit

66 Letter published by Ragnar Rylander in the New Scientist,5. 30.1998, p.56. 67 Memorandum Kloepfer to Childcote, 3.29..1983, TIMN 269624. 68 Eur J Respir Diseases, Supplementum no. 133, vol 65, 1984. Rylander R., Introduction. 69 Cover letter, Kornegay to Surgeon General Kopp, 03753486/7. 70 Communiqué from Tobacco Institute, .2.14.1984, 506638902/4. 71 « Smoking in public : Let’s separate fact from friction.» 511425456. 72 Letter from Chilcote to Tucker,.4.17.1984, 506638899/901. According to Mme Snella, this was sent via payment by cash on delivery and thus did not involve financing from the University. 73 U.S. Environmental Protection Agency : EPA/600/6-90/006A.

18 this report and avoid more severe sanctions concerning smoking in public places.74 Philip Morris’ plan was clear:

"Our overriding objective is to discredit the EPA report and to get the EPA to adopt a standard for risk assessment for all products.

Concurrently, it is our objective to prevent states and cities, as well as businesses from passing smoking bans”.75

The main weapon in this strategic plan was to form a “coalition for integrity in science”, defined as follows:

“A national coalition intended to educate the media, public officials and the public about the dangers of “junk science.” Coalition will address credibility of government’s scientific studies, risk assessment techniques and misuse of tax dollars.”

The populist theme of taxpayers’ money being wasted to promote “politically-correct” science was used to discredit a number of honest researchers whose work highlighted the danger of smoking for non-smokers. This disinformation campaign would not have been possible without the participation of scientists perceived to be outside the TI world. Since it was a foregone conclusion that in any battle involving “the TI versus Science” the TI would lose, the controversy had to be turned into a battle amongst specialists within the world of science.

« The Philip Morris approach is that the industry’s position on the science is correct, but that it is better to have someone else say it because industry itself cannot win a causation argument. »76

The EPA called for comments from the general public on the document and the TI encouraged expert consultants to give their opinions. Ragnar Rylander was so addressed and in the wake of consultations with T. Osdene77 and the law offices of Shook Hardy and Bacon, he submitted his critical comments to the EPA78. He attacked the biological plausibility of the causal mechanism invoked for the harmfulness of passive smoking and suggests that the findings resulted from confounding factors, in particular dietary habits. This theme became a focal point of his own research on the subject. It is true that the argument of biological plausibility plays an important role in epidemiology. Nonetheless, Ragnar Rylander’s good faith on this issue should be subject to caution. In fact, in his capacity as a representative of Philip Morris for INBIFO, Ragnar Rylander was well-informed of the toxicity of

74 Muggli ME, Forster JL, Hurt RD, and Repace JL. The Smoke You Don’t See: Uncovering Tobacco Industry Scientific Strategies Aimed Against Environmental Tobacco Smoke Policies. Am J Public Health 2001;91:1419-23. 75 Memorandum Campbell to Merlo,2.17.2.1993, 2021183916/30. Another significant quotation:: « Science should never be corrupted to achieve political ends ».Who would contradict this highly moral saying which was taken from a list of “key messages” concocted by the masterminds of the disinformation campaign by Philip Morris. In the « newspeak » of cigarette manufacturers biased science became science of integrity, honest research became « the pursuit of political ends » , trth became lies and lies, truth. 76 Cité par K. Kleiner : « Us against them » New Scientist, 2.5.1998, p.22 77 Fax by Rylander to Osdene, 7.18.1990, 2021183916. et du 7.8.1990, 2023533784 78 Mémorandum Rylander du 12.7.1990, 2023533785/91.

19 passive smoking: he received the findings of toxicological studies conducted at the institute. As of the early 1980s, moreover, he cited work underlining that, ceteris paribus, passive smoking (which toxicologists dubbed“sidestream” smoke, the smoke which drifts from the end of the lit cigarette when the smoker is not inhaling) is the cause of more serious histological anomalies in animals than mainstream smoke (which is smoke directly inhaled through the burning cigarette by the smoker).79

3.2.3. Ragnar Rylander’s Chinese Connections and the TI’s Asian Policy

During the same period Ragnar Rylander also suggested to Osdene that it might be politically expedient for a Hong Kong colleague, Dr XXX, to submit comments to the EPA as well.80 Dr XXX was an epidemiologist attached to the Department of Community Medicine of the University of Hong Kong whose ties to the TI were comparable to those of Ragnar Rylander. The long-term collaboration between Ragnar Rylander and Dr XXX led to an attempt by the TI, seemingly instigated by Ragnar Rylander, to infiltrate the University of Hong Kong. It is known that by the late 1980s certain TI executives had given up all hope of countering anti-tobacco measures that were progressively to be implemented throughout the West in the long-term, and focused the main thrust of their propaganda on emerging Asian markets.81 Hence, a program was set up to “recruit and train” scientists in the region, to carry out research programs geared toward TI interests, and offer their “independent expertise” to political circles. 82 Professor Anthony Hedley, director of the department at the University of Hong Kong where Dr XXX worked, discovered that Professor Rylander was involved. Ragnar Rylander tried to influence Dr XXX’s career by writing the Vice-Chancellor at the University of Hong Kong a letter describing Dr XXX in glowing terms, suggesting she be promoted to the head of a cancer epidemiology unit that was to be created from scratch, and promising scientific and financial backing from the University of Göteborg.83 Coming as it did from someone outside the university community this initiative seemed very strange indeed, especially since Ragnar Rylander had contacted neither the person above Dr XXX in the hierarchy (Professor Hedley) nor the Dean of the Faculty of Medicine and moreover, Dr XXX was already embroiled in a controversy at her institution. At the heart of this conflict were the suspicions cast on Dr XXX because of her ties to the TI, which would be corroborated subsequently upon publication of documents from the American trials84. Professor transmitted his negative reaction and suspicions to the Dean of the Faculty.85 Nevertheless, on April 25th Ragnar Rylander announced to T. Osdene that plans for

79 Letter from Rylander to Osdene dated 1. 26.1982, 1000081782. This aspect of the affair is analyzed in detail in: P. Diethelm, JC Rielle, M. McKee: The whole truth and nothing but the truth? The research that Philip Morris does not want you to see. To be published in Lancet 80 Letter from Rylander to Osdene dated 8. 15..1990, 2023533777. 81 South China Morning Post, 18-20.1.1999, AH 82« Asia ETS Consultant Status Report », 2500048976/98. 83 Letter from Rylander to Wang 2. 17..1989, AH. 84 This aspect of the « XXX affair » also lead to legal action initiated by Dr XXX but she also lost on appeal, seen in detail in a letter from Pr Hedley to Pr Mauron du .3.11.2004, AH 85 Letter from Hedley dated 3. 30.1989, AH.

20 the new unit were well under way and gave him a copy of “XXX’s formal proposal to the University”.86 Given that such a proposal had never been made and that at that point the conflict between Dr XXX and the University was turning into litigation, Professor Hedley deemed Rylander to have truly cheated Philip Morris by luring them along with a tempting but unrealistic scenario. Later Ragnar Rylander tried to deal with Professor Hedley directly, but to no avail.87

However, documents bear witness to contacts established in Hong Kong among Ragnar Rylander, T.Osdene, Dr XXX and Dr YYY. Dr YYY headed the company EHS Consultants which won a contract from the government of Hong Kong to conduct a study on the quality of air in offices and public places88, in which Ragnar Rylander also participated. 89 He was coopted by the team in charge of the study and most likely played a key role. This study for the Department of the Protection of the Environment was not really conclusive in scientific terms and was contested by Professor Hedley, especially the parts dealing with passive smoking, for the study was tainted by grave conflicts of interest. In the aftermath of a study which was facilitated by the publication of the first documents emanating from the Minnesota Settlement, the press brought these conflicts to light, in particular those concerning Ragnar Rylander.90 It is also worthy of note that China was a source of activity for Ragnar Rylander throughout the 1990s. He was part of the scientific committee of the International Workshop on Risk Assessment and Good Epidemiological Practices held in Guangzhou 14-17 July 1997. This seminar, sponsored by the Center for Air Research (CIAR) was part of the TI’s disinformation campaign on passive smoking through the promotion of alleged “good epidemiological practices “

To sum up, the documentation clearly shows that Ragnar Rylander followed instructions from the industry on how to carry out his activities on links between tobacco smoking and health. His language was at times that of an activist: the point was to defend the TI “cause”91; the adversaries of smoking were labelled “antis” 92 . Ragnar Rylander enjoyed substantial financial benefits in the form of fees or travel allowances from his association with the industry all of which probably began early on in his research career.93.

3.3 Study on the Dietary Habits of Non-Smoking Women Living with Smokers or Non-Smokers. In the wake of the controversy triggered by the Environmental Protection Agency document, and due to the closure of his toxicology laboratory in Geneva, Ragnar Rylander reoriented part of his activity towards epidemiology. Although today he invokes

“the academic tradition that in principle allows researchers to address any decisive issue”,94

86 Letter from Rylander to Osdene, 4. 25.1989, 2023537814 87 Letter from Rylander to Hedley , 11. 9.1990, AH. 88 Letter from Hedley to Mauron, 3. 11..2004, AH. 89 The same company coopted Chinese scientists to work for CIAR, an institution seen further on. loin 90 South China Morning Post, 18-20.1.1999, AH 91 Letter from Rylander to Osdene, 8. 15.1990, 2023533777 92 Letter from Rylander to Carchman, 3. 15.1996, 2074670553/4. 93 Letter from Dalhamm to Parmele ,.11.30.1962, 00105437. 94 Letter from Rylander to Mauron 1. 26.2004.

21 Philip Morris played an important role in orienting Rylander’s research toward epidemiology and the theme of passive smoking. In the early 1990s the TI’s scientific position was undermined by the accumulation of data incriminating passive smoking in many pathologies found in children and adults.

The idea of one or several European studies on dietary habits of non-smoking women living with smokers or non-smokers was launched by Philip Morris in 1993. The avowed goal was to obtain data showing that women exposed to passive smoking have a lifestyle that increased the risk of lung cancer, independently of their exposure to passive smoking. The TI was encouraged in that direction by the preliminary studies of the data analysis of an American inquiry entitled National Health and Nutrition Examination Survey by Professor G Matanoski in Baltimore.

From the outset Philip Morris specified that all the studies would be organized and funded by the Center for Air Research (CIAR), an institution almost entirely controlled and financed by the TI. 95 This body offered a façade of scientific independence to research sponsored by the TI.9697CIAR had already backed a symposium on “methodological aspects in assessing low-risk agents in lung cancer”, held in Clearwater, Florida , and Ragnar Rylander had published the report98 Ragnar Rylander would later claim that CIAR was an “ordinary” research foundation, which allocated funding for research projects on the basis of competitive applications.99 In fact Ragnar Rylander’s work on passive smoking were specifically and exclusively funded by Philip Morris but through the intermediary of CIAR, as we shall see further on.

On May 26, 1994 Ragnar Rylander told Richard Carchman, a Philip Morris executive, that he was interested in submitting a study protocol on the dietary habits of non- smoking women living with smokers or non-smokers.100 In June 1994, Ruth Dempsey of Philip Morris contacted Dr Rylander

95 Fax from Rylander to Dempsey, .6.20..94, 2026222501/2. 96 Memorandum from Charles to Pages 5. 14.1992, 2021528170. 97 McKee M. Smoke and MiRagnar Rylanderors : Clearing the air to expose the tactics of the tobacco industry. Eur J Public Health 2000 ;10 :161-5. 98 Rylander R, Peterson Y, and Lebovitz MD. Assessing Low-Risk Agents for Lung Cancer : Methodological Aspects. Int J Epidemiology 1990; 19 Supplement 1.We note that it is often supplements to scientific journals that are the chosen means of disinformation caRagnar Rylanderied out by Ragnar Rylander.as they allow publication of colloquia reports without true peer review. 99 Rylander R. Potential conflicts of interest and the need for full disclosure : reply. Eur J Public Health 2000;10:235. 100 Letter from Rylander to Carchman 5. 26.1994, 2026222511

22 and discussed the precise objectives of his study, which initially was to be done in Sweden alone. During the summer of 1994 Dr Rylander submitted his project to CIAR. CIAR 11 August 1994 report clearly indicated that

Philip Morris is prepared to carry the full burden of support for this study through CIAR. Nevertheless, it requires CIAR Board of Directors approval in order for it to proceed as a center project".101

On August 11, 1994 Ragnar Rylander proposed to extend the Swedish study to include Switzerland and to conduct the two studies in parallel. 102 On 25 September 1994 Ragnar Rylander wrote Dr Carchman of Philip Morris that he had gotten wind of confidential data form the National Cancer Institute. He explicitly mentioned that the goal of his project in Geneva was to show that differences in dietary habits accounted for the different risk levels of cancer or cardiovascular diseases between women who were exposed or not exposed to passive smoking:

"From confidential data at the National Cancer Institute, I learned that when the intake of fat was corrected for, the risk due to ETS disappears. This is good news and supports our CIAR project. The questionnaires should be ready early next week and then we can start. I realize the time pressure 103

On February 1995 CIAR sent Dr Carchman written confirmation that the Rylander study would be exclusively financed by Philip Morris.

"The Rylander study will be solely funded by Philip Morris. Billing will commence in 1995104

The data was collected in 1995. Throughout the course of the project Ragnar Rylander kept his correspondent at Philip Morris , Dr Carchman, informed of the developments on results. If he did benefit, as he claimed, from CIAR funding for an independent research project, Ragnar Rylander would have had no reason whatsoever to keep Philip Morris informed on developments in this manner.

On February 1995 CIAR confirmed receipt of US$151,600 from Philip Morris for Rylander’s study105.

On 15 March 1996 Ragnar Rylander wrote to Carchman about the passive smoking project in Geneva and Göteborg:

“Interestingly, this project has so far not received any hostile comments although an outcome along the lines we have seen in the preliminary analyses would obviously represents an intellectual drawback for the antis."106

101 Memorandum Eisenberg à Carch, Grenn, Heck, Kass, Mueller, Rolf et Spears, 2050754285A. 102 Letter from Rylander to CIAR with annex, 8.11.1994, 2028381494/5. 103 Fax fromRylander to Carchman, 9.25..1994, 2050754280. 104 Letter from Eisenberg to Carchman, 2. 9.1995, 2050764516/8. 105 Invoice from CIAR to Philip Morris for the attention of Dr Carchman, 2.23.1995, 2050764511. 106 Lettre Rylander à Carchman du 15.3.1996, 2074670553/4.

23 The “antis” were the scientists who were convinced of the harmful effects of passive smoking. In the autumn of 1996 Ragnar Rylander wanted to conduct an analysis of the dietary habits of smokers and non-smokers (in addition to that on passive smoking). CIAR refused because it didn’t subsidize studies on smokers. Rylander tried to negotiate directly with CIAR. On 21 October 1996 he sent Max Eisenberg of CIAR a letter showing that Ragnar Rylander was perfectly aware of the funding mechanisms for his projects:

« How could we resolve the problem vis-à-vis CIAR? One possibility is to drop the manuscript completely. I think this would be a pity, considering the reasons given above. Another possibility is that it is published but that CIAR is not acknowledged. We need to further discuss this to avoid any unnecessary complications with CIAR policy 107

Later Ragnar Rylander was to ask for funding to repeat the first study, which this time would include a comparison between smokers and non-smokers. CIAR turned him down. It was thus Philip Morris that directly funded the second study. Ragnar Rylander was concealing the facts when he wrote:

« All my requests for funding were submitted to CIAR ».108

It should be noted that the manuscript of the second study109, which in the end would never be published, mentioned Philip Morris’ support.

At the same time Ragnar Rylander set up a study on the magnesium content of drinking water, still with the idea of proving that passive smokers were exposed to other risk factors than smoke. On 27 November 1995 he mentioned to Dr Carchman that:

The project has now become of interest to the Department of Internal Medicine at the University Hospital."110

On May 22, 1996 Ragnar Rylander explained to Carchman that the conclusion of his work on magnesium matched the industry expectations, namely:

"The bottom line of the magnesium story (…) is that you can never make a reliable epidemiological study on cardiovascular disease without controlling for magnesium intake."111

The close links between Ragnar Rylander and the TI have been documented concerning this entire case by means of copious correspondence which is accessible on Internet. The documents clearly exclude any possibility that Ragnar Rylander had been, concerning the subject of passive smoking, an independent researcher whose work was partly funded by the TI. This image that Ragnar Rylander has tried to

107 Fax from Rylander to Eisenberg , 10. 21.1996, 2063590941/3. 108 Lettre Rylander à McKee du 18.7.2001 109 Study ”Dietary habits and smoking in Swedish and Swiss population samples”, 2074457220/49. 110 Lettre Rylander à Carchman du 27.11.1995, 2505531000/1. 111 Lettre Rylander à Carchman du 22.5.1996, 2063590992.

24 project about himself does not correspond to the facts. The same behavior is found in the context of another Geneva study on children’s exposure to passive smoking that shall not be explored here as it has been abundantly commented upon in the framework of legal proceedings. In fact, in its final ruling the Cour de Justice (Court of Appeals) delved with great detail into the influence the TI had on the conduct and interpretation of the study.112

4. Conclusions

It should be noted that the Commission is not concerned with Professor Rylander’s opinions, nor by the quality of the epidemiological work he has carried out, nor by the fact that he accepted research subsidies from the TI. What is at issue here, in the view of the scientific community, is his premeditated concealment of his close ties to the TI. Ragnar Rylander has knowingly acted to cover up his connection to the industry and lead the scientific community to believe that he was an independent researcher. The Commission believes that Professor Rylander compromised his independence as a researcher as a result of his close ties to the TI and blames him for having hidden the true scope of these ties.

It has been shown that due to his close association with the TI and the duplicitous attitude he has adopted throughout his professional life, Ragnar Rylander not known how to maintain intellectual independence from certain vested interests. The documentation leads us to believe that throughout his career Ragnar Rylander has taken the position of unilaterally defending the TI’s vested interests in their conflict with scientists who were convinced of the harmfulness of smoking. He helped to forge the industry strategy, accepted a secrecy clause in his contracts with the industry which led him to conceal information on the toxic effects of tobacco that he was well aware of. The Commission believes that it is legitimate to doubt the validity of the overall work that Ragnar Rylander engaged in pertaining directly or indirectly to smoking.

The fundamental grievance raised against Ragnar Rylander is to have concealed his ties with the TI, to have lied about the nature of the relationship and participated in a disinformation campaign under a falsely independent scientific cover. The losers in this affair are: - The Faculty and the University of Geneva whose infrastructures have been wrongly used and whose reputation has been tarnished by Ragnar Rylander’s actions; - The scientific community, mislead by symposia whose preparation and findings were manipulated by the TI and by tendentious epidemiological studies whose purpose was to unnecessarily prolong uncertainty and controversy; - Lastly, above all the general public, which benefited belatedly from knowledge on the specific toxicity of passive smoking which was acquired in the 1980s and deliberately kept hidden whereas this knowledge might have led to headway in preventing tobacco-related pathologies.

112 Decision of the Cour de Justice, hearing, Monday, December 15, 2003.

25 - 5. Prof Rylander’s Defense113 - Prof Rylander’s defense initially consisted of minimizing his association with the TI, then to assert that this association was of common knowledge to the scientific world. Moreover he believes that these ties were legitimate given the entitlement to academic freedom. The opprobrium leveled today against any collaboration with the TI represents a “value judgment” which did not apply at a time when such contacts were normal. If he expresses any regret at all it is not to have felt the tide turn in public opinion on the subject earlier. Moreover, he disqualifies the courts that have judged him, which lack, in his view, the necessary scientific competence. The scientists who on various occasions intervened in the controversy (Abelin, McKee, Hedley) are also disqualified because they are “very anti-smoking”. During his hearing before the Commission Prof Rylander presented the genealogy of the “Rylander symposia” as well as his work on passive smoking as the result of a purely scientific and impartial system of logic. He pointed out additionally that other researchers espoused opinions which were comparable to his own. When faced with the documents that illustrate the guiding influence the TI had in developing his activities Prof Rylander put this down to a selective reading of the documents motivated by the malice of Mr. Diethelm and Mr. Rielle. He denies that he or his work became the tools of the TI. He acknowledges, it is true, that some of his scientific findings were useful to the TI but emphasizes that they were also useful in public health. In particular the information on the importance of diet.

In the written conclusions he submitted after his hearing he interpreted his collaboration with the TI as a contribution that is ethically defensible based on the “polluter/payer” principle, since TI bears the research costs on a harmful product114

The Commission believes that Prof Rylander’s a posteriori rationalization would be more convincing if his scientific work on passive smoking, the way it was produced under the influence of the TI and his oft-expressed positions on the subject did not aim specifically at casting doubts as to its harmfulness. The way the symposia were organized and the ongoing collusion between Prof Rylander and the TI in carrying out research go far beyond current usage in academic research, even when collaborating with industry. Furthermore, the Commission notes that Prof Rylander did not spontaneously admit to any relationship with the TI, that is to say before being confronted with undeniable proof of such ties.

In the aftermath of the inquiry the Commission concluded a deadlock had been reached. The Commission’s discussions with Prof Rylander have not enlightened it further on the affair beyond the numerous statements that came out during the course of the legal proceedings. It believes that it is now up to the university authorities to shoulder their responsibilities on the basis of the evidence gathered here as well as from court decisions, elements which speak for themselves. 6. Recommendations

113 Prof Rylander’s hearing before the Commission, 3.16.2004, and letters from Rylander to Mauron dated 1. 26.2004 et 3.23.2004. 114 Letter from Rylander to Mauron date 3.23.2004.In this letter he expressed his regret that the Commission held him responsible for the popular and simplistic views the public-at-large entertained regarding scientists’ collaboration with the TI.

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The Fact-Finding Commission finds that it owes a duty to propose to the Delegate on Scientific Integrity at the Faculty of Medicine as well as to other faculty and university authorities that the following measures be adopted:

1-The Scientific community and the public-at-large should be informed that Ragnar Rylander’s work on the effects of environmental smoke on health have been cast under serious suspicion since the researcher did not disclose any conflict of interest likely to influence the scope of his work and that given the role he played as a secret employee of the tobacco industry, he cannot be held to be an independent scientist. The Fact-Finding Commission proposes to send written notification of this to the following journals: -European Journal of Public Health -Archives of Environmental Health -International Journal of Epidemiology

2-The impact of Professor Rylander’s lack of scientific integrity can only be fully understood within the context of the strategy designed and undertaken by the tobacco industry to create doubt as to the toxicity of smoke, in particular for non- smokers. Although this is an individual case we should not overlook the fact that the most unpardonable guilt results from the institutional and commercial power of the tobacco industry whose objectives and interests clash with those of both public health and medical science. The copious documentation stemming from the tobacco industry, made public through rulings against the industry in American courts shows that these companies tried to manipulate public opinion for decades and that the targeted involvement of many scientists has been a useful instrument in this endeavour to disseminate misinformation . The tobacco industry cannot be considered a credible partner of independent scientific research. The Commission proposes that henceforth members of the University be prohibited from requesting, directly or indirectly, research grants or consultancies from the tobacco industry. This measure is designed to protect the scientific integrity of researchers.

3-Given the current context, this prohibition probably will have more of a symbolic impact. The Commission wishes to ensure that its recommendations will measure up to the challenges before us in the future and thus proposes that the Faculty and the University engage in thoughtful reflection on links between university research and the private sector. Private financing of biomedical research is an inevitable fact of life for therapeutic innovation, particularly regarding the pharmaceutical sector. This is nothing new; moreover, such partnerships are necessary for new therapies to be developed. Nevertheless the very nature of the bonds between industry and academic research are undergoing deep-seated changes. We have moved from two distinct worlds that obeyed their own rules to one where an increasingly close interlinkage prevails, due, in particular, to the need to give economic value to scientific knowledge. The question that the entire university community must now

27 urgently address is: how these partnerships can be organized in a mutually beneficial manner, consistent with the university’s primary mission, that is, a disinterested quest for scientific knowledge. The Commission urges university authorities to take proactive measures to anticipate and control developments in this domain.

4- A lack of vigilance at the time facilitated the serious infringements to scientific integrity for which Ragnar Rylander is held accountable. The Commission wishes all members of the University to be reminded of the rules that will henceforth be applied concerning transparency and disclosure of conflicts of interests that must govern their relations with the University, university departments, financing entities for research, and scientific journals. Furthermore, challenges to scientific integrity are in constant flux and require ongoing adaptation from the University. When the need for new rules arises, they must be designed with and accompanied by penalties in case of breaches. Moreover, University, faculty, and departmental management must be kept abreast of accessory activities (consultancies, involvement with commercial enterprises) by members of the faculty and staff and standards for curriculum vitae must reflect this demand. This also holds true for associate professorships, a post which has proved its worth in bringing in outside talent to university but which should not lead to any administrative laxity.

5- The Commission wishes information and specific training to be organized for young researchers, to empower them to practice their profession clear-sightedly so they can act as knowing and discerning collaborators with industry. The Commission proposes that the Rectorate and Deans organize a consultation on how this should be carried out. This would be a continuation of the work currently in the pipeline by the Rectorate to disseminate guidelines on scientific integrity to all faculties. These guidelines should be taught in a specific educational context involving practicing researchers and other specialists.

Since Rylander has retired and administrative liability is time-barred115, we have not been called upon in this report to propose disciplinary measures.

This said -and it would be worth mentioning this regularly to the political authorities- biomedical research requires a solid foundation of public financing. Without such funding, the ethical principles on research expounded here may be eroded by the rising costs of cutting-edge research, especially in the fields of public health and preventive medicine, where the gap between the public’s welfare and certain vested interests seem insurmountable.

Finally, the Commission would like to thank Mr. Pascal Diethelm, Dr Jean-Charles Rielle and Professors Anthony Hedley and Martin McKee who have played a key role in examining this affair.

115 Conclusions and measures of the Rectorate (6 November 2001, § 1.2

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Geneva, September 6, 2004

The Fact-Finding Commission:

Prof Alex Mauron, Chairman

Prof Alfredo Morabia Prof Thomas Perneger Prof Thierry Rochat

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