Rylander Case

Geneva Court of Justice

Session of 26 August 2002


Status report


Last year, our two associations, CIPRET-Genève and OxyGenève, both located in Geneva, Switzerland, have made public revelations about the secret ties of Ragnar Rylander, former professor of environmental medicine at the University of Gothenburg, with the tobacco industry, and showed how he was used by Philip Morris to infiltrate the University of Geneva and use the institution's name and reputation as a shield to conduct and publish studies and organize symposia which were controlled by Philip Morris lawyers and funded by the multinational. CIPRET-Genève and OxyGenève denounced this as a "fraud without precedent". Ragnar Rylander has sued Jean-Charles Rielle, physician-in-charge of CIPRET-Genève, and Pascal Diethelm, president of OxyGenève (author of the current report), charging them of defamation against him.. In first instance, the tribunal has upheld 95% of the revelations made by the two associations, keeping unchallenged the essential part of the revelations, and going beyond them on some aspects. The tribunal ruled that Rylander worked secretly for the tobacco industry and observed that he had changed the results of his studies to meet his sponsor's expectations. However the tribunal determined that the two defendants had not sufficiently proven that he was "one of the most highly paid consultant of Philip Morris" and that he was involved in a "scientific fraud without precedent". Consequently, the two defendants were condemned to pay a fine of CHF 4'000 each. The decision was appealed. On 26 August was the first session of the appeal.


Three witnesses came to the bar, Dr Hubert Varonier, Dr Paul Bouvier and Dr William Farone. Although the lawyer of the other side tried his best to create disruption and confuse the new judge, the session overall went well for us.


Dr Varonier, the honorary president of CIPRET, and a Swiss specialist of allergy in children and ETS, confirmed his prior assessment that there was "manipulation" in the children study undertaken by Rylander (that was eventually published in Archives of Environmental Health). He said that the "corrections in the database" undertaken by Rylander to remove the correlation between respiratory infections and exposure of children to ETS was for him evidence of such manipulation. Dr Varonier did not accept Rylander's explanation that "corrections in the database" means applying logistic regression. The "corrections in the database" happened after Rylander had shown his preliminary results to Philip Morris and had met with them and their lawyers in Richmond. Dr Varonier confirmed that the SCARPOL study, of which he was an investigator, included 4'470 children of the same age as those studied by Rylander; it arrived at conclusions opposite to those presented by Rylander. The SCARPOL study is the reference study in Switzerland for children exposure to ETS. It was observed that Rylander did not include it among his references. Dr Varonier confirmed his initial conclusion that such corrections and change of methodology halfway throughout a study constitutes manipulation. When asked about the difference between manipulation and fraud, he said in substance that the two terms are synonymous.


Dr Paul Bouvier testified in his capacity as President of the Ethics Commission for Epidemiology and Public Health. Dr Bouvier presented the history of the commission, which he chairs since 1994. The Commission has reviewed study protocols presented by Ragnar Rylander. Dr Bouvier was then asked questions about the report from the University of Geneva on the investigation that followed our revelations. The report asserts that the Ethics Commission, when reviewing Rylander's study protocols, did not object about the financing of the projects by the tobacco industry, although the commission was aware of the source of funding (p. 8). Dr Bouvier categorically denied this allegation and referred to the minutes of the commission meetings to show that its members did not know, and were far from even suspecting that Rylander was paid by the tobacco industry. On one occasion, a member of the commission indicated that a proposal submitted by Rylander (it was the 1997 confounder study eventually published in EJPH) could produce results that could be potentially very useful to the tobacco industry and indicated that they were rumors that the tobacco industry was financing projects of this kind. This concern was communicated to Rylander, apparently with no effect.


Dr Bouvier then indicated that the ethics commission has been using since it creation the CIOMS International Guidelines for Ethical Review of Epidemiological Studies 1991 (http://www.cioms.ch/frame_1991_texts_of_guidelines.htm). According to the guidelines, in particular rules 27 and 29, Rylander had an ethical obligation to disclose his conflict of interest to the commission, and Dr Bouvier added that if they had known that the project was financed by Philip Morris and had learned about Rylander's ties with the multinational, the commission would not have approved the project in application of Rule 29.


Dr Paul Bouvier said the commission did not have a definition of scientific fraud until very recently, more precisely until the Rylander case was made public. This case has actually triggered a range of changes in the way ethical issues are treated at the university. For example, the commission has only recently adopted a procedure whereby they ask scientists to sign a declaration concerning the absence of conflict of interest and concerning the source of funding. Before that, the commission was not required to ask applicants who submitted protocols to declare their source of funding. Rather, the commission operated under an honor system, relying on the fact that applicants had an ethical obligation to declare their potential conflicts of interest.


Dr Bouvier's deposition went through a very intense moment. He was asked by the defense lawyer whether he considered that Ragnar Rylander's projects (the children study published in AEH and the confounder study published in JEPH) constituted cases of "scientific fraud". The answer was a clear and unambiguous "Yes!". This outraged the plaintiff's lawyer. He made a big fuss, saying that this was an expert testimony, and that the witness was deposed as factual witness, not expert. He objected to including Dr Bouvier' s answer in the record. The defendants unfortunately lost this point on procedural ground. This could have been a turning point from which the rest of the case would have gone downhill. However, the incident revealed to all present that the president of the ethics commission is convinced that there was a scientific fraud. Given that he is highly esteemed as a very rigorous, objective and honest person with great integrity, one can only presume that he has in his possession irrefutable evidence on which he based his conclusion.


The last witness, Dr William Farone, worked for Philip Morris between 1976 and 1984 as director of applied research. He confirmed that Rylander was employed by Philip Morris at that time and was reporting to Philip Morris, doing research protocols and other work based on orders given to him by Thomas Osdene, the director of R&D, with whom Dr Farone had close contacts. Dr Farone confirmed that the arrangement between Philip Morris and Rylander was treated as "Top Secret" in the company. He explained the role of INBIFO as a secret laboratory that was owned by Philip Morris and whose existence and role was kept secret even with Philip Morris own scientists. Dr Farone learnt about these arrangements in senior scientific management meetings and in discussions with Osdene. Dr Farone explained that direct lines of communications between Philip Morris USA and INBIFO were suppressed. He described the elaborate scheme whereby documents and communications issued by INBIFO were first sent to Rylander who would then pass them on to Osdene at Osdene's private home. Osdene would read them and then only communicate to selected members of his staff the indications that he decided to release. The purpose of the scheme was that documents about sensitive research could not be produced in US tribunals and for regulatory agencies.


Dr Farone explained that when he was at Philip Morris, himself and all his scientific colleagues knew that active and passive smoking caused cancer and other diseases, and he never heard anybody say that this was not the case in his eight years with Philip Morris. This knowledge is actually one of the reasons he was hired by PM: to make a safer cigarette, by trying to remove some of the carcinogens contained in smoke. On the other hand, Philip Morris was publicly denying that cigarettes cause cancer and that passive smoking cause disease. It kept denying it until 1999 for active smoking and 2000 for passive smoking. He said that Rylander was an active participant in this policy of denial, and he concluded by saying that this overall denial has been the central point that led juries in many US trials to convict Philip Morris and other tobacco industries of fraud.


This ended the session. The deposition of the other three witnesses will take place on 23 September. The witnesses will be Dr Theodor Abelin, Prof. Martin McKee and Prof. Thomas Zeltner.


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