on children and respiratory diseases
Pascal A. Diethelm
Our goal is primarily to compare populations that exposed or not to a particular factor (magnesium, tobacco) and to put this factor in relation with other environmental factors. Protective factors (magnesium) and associated or confounding factors linked to life habits (smoking). Our investigations aim at issuing recommendations for methodologies that are applicable to environmental studies.
Responsable : Prof. Ragnar Rylander, physician
Respiratory infections in children and environmental
To determine the influence of dietary habits and other environmental factors on respiratory diseases in 4-6 years old children.
No relation between dietary habits and respiratory symptoms. Environmental tobacco smoke does not modify the risk of diseases. However, we found a causality relation between some symptoms and humidity or the presence of mold in the house.
The above conclusion may surprise many readers: “Environmental tobacco smoke does not modify the risk of diseases.” In other terms, the authors of the research state that exposure of children to tobacco smoke has no incidence on their respiratory health.
The same conclusion can be found in an article published by Prof. Rylander and a co-author, in the September/October 2000 issue of Archives of Environmental Health (AEH):
The number of cigarettes smoked at home or any other expression of ETS exposure was not related to an increased risk for disease. […] In conclusion, we demonstrated that home conditions (i.e., humidity, presence of molds, and number of years spent at day-care centers) were major risk factors for respiratory infections in children. Dietary items and ETS exposure were not associated with an increased risk for any of the diseases studied.
conclusions go against the established scientific consensus on the subject. For
instance, the World Health Organization convened an International
Consultation on Environmental Tobacco Smoke and Child Health in
The Consultation concluded that ETS is a real and substantial threat to child health, causing death and suffering throughout the world. ETS exposure causes a wide variety of adverse health effects in children, including lower respiratory tract infections such as pneumonia and bronchitis, coughing and wheezing, worsening of asthma, and middle ear disease. Children’s exposure to environmental tobacco smoke may also contribute to cardiovascular disease in adulthood and to neurobehavioural impairment.
The Swiss SCARPOL study has also investigated the impact of ETS on respiratory health and has published its findings in an article entitled “Effects of environmental tobacco smoke exposure on respiratory symptoms in children”. Based on a survey of 4’470 children aged 6-14 years, the study reaches conclusions that are very similar to those of the WHO experts:
half of all schoolchildren in
is difficult to determine by what route the two researchers from the
When scientists are confronted with a situation of conflict of interest where the main financial sponsor of their work has an interest in the results, especially when the subject is sensitive and/or controversial and has an important public impact, ethics normally requires that they declare their sources of funding in all their publications and presentations. This transparency should allow, among other things, others to interpret their results with the necessary degree of caution. It is indeed notorious that industries are very reticent to finance research that produce results that are contrary to their interests. It is rather unfortunate that Rylander and his co-author have omitted to mention the source of funding of their project. Neither the web site of IMSP, nor the article in AEH, contains the slightest hint that the project was financed by Philip Morris.
We will quote extracts from a series of documents obtained from the Philip Morris web site that relate to the study undertaken by Rylander and his assistant on the relation between environmental factors and respiratory diseases in children. These documents, which constitute a very small subset of the whole collection of documents relating to Rylander, make it possible to reconstruct to a large extent the evolution of the project and the framework in which it took place, and to get an idea of the motivations that guided it. We realize that such a reconstruction, based on documents that essentially come from a single source, runs the risk of being incomplete. Thanks to the “quality” of the documents, we think that it nevertheless allows us to apprehend in a sufficient way the initial elaboration, the financing and the development of the study on children and respiratory diseases that lead to the publication in AEH. This is already by itself very instructive.
quoting the first document, which dates back to 1990, let us set the stage. In
1990, Dr. Ragnar Rylander is professor of environmental medicine at the
first mention of the
I visited Inbifo
yesterday and we had a good discussion on ETS. I have initiated a pilot study in
substance, it appears that a good discussion on ETS at INBIFO has prompted
Rylander to start his study on children. The hypothesis at this initial stage is
rather general, perhaps understandably.
As agreed I will keep you
informed about the development in the following special projects :
1. Linda Koo group developments particularly risk factors for lung cancer in in-smokers
letter refers to an agreement that was passed between Philip Morris and
Rylander. We have no information on the exact terms of the agreement. It should
be noted that, from the outset, the
questionnaire for the child respiratory disease/diet project in
It is worth observing here that Rylander starts the study, does the preliminary analysis and then considers discussing methodology and criteria for symptoms. When looking for advice from someone knowledgeable in respiratory diseases, it is also interesting that Rylander does not envisage any of his colleagues in Switzerland, where expertise in respiratory diseases is not lacking (for example, professor Leuenberger of the neighbor university of Lausanne would have been an obvious choice). He proposes the name of Mike Lebowitz, a consultant for the tobacco industry.
also reviewed the
Rylander says to Osdene that he will need more money “if the data look good”, he
cannot ignore that for Osdene, good data are data that support the industry
position, in other words data that either exonerate passive smoking of any
serious harmful effect on the health of non-smokers or at least entertain the
controversy about such effects.
fax from Rylander to Osdene on
various projects are proceeding nicely – we now have 150 interviews completed in
The field work for the
child-diet-respiratory study in
15 July, Rylander sends a fax to Donald Hoel, the lawyer from Shook, Hardy &
Bacon, the law firm in
anything come up concerning visit to
Please give me a call at home whenever convenient.
With my best regards
message is well received and even creates some stir. In a post-scriptum dated
I am also enclosing for you a copy of a telefax message I recently received from Dr. Rylander. You will see that he is working on an editorial on children’s respiratory diseases and ETS exposure. I am not sure what this is about but in all probability it will be important for us. While I do not have any immediate trips planned for
answer is contained in a handwritten note (which can be attributed to Steve
Parrish) on the same document:
said “no”. They will meet in
project to write an editorial on children and ETS appears as a highly sensitive
subject for Philip Morris. Interestingly, the lawyer does not seem too concerned
about the eventuality that it could upset Rylander that a lawyer be delegated by
Philip Morris to assist him in the “editing” of his report.
his reports on monthly activities for July 1991, addressed on 5 August to Steve
Parrish, R.A. Pages, Principal Scientist in
1. Discussions with Don Hoel: CIAR budget and bylaws; Rylander—currently working on an editorial re children’s respiratory disease and ETS; OSFA; T. Sterling.
Rylander’s project on children appears to be a matter of importance that is debated at a fairly high level in the PM hierarchy, and is treated on the same level as the CIAR budget and bylaws.
Back from vacation and
overload already; several points to discuss. Enclosed please find the invoice
for project funds September/October. It would facilitate very much if it was
possible to have a first $6000 from the NovDec funds – the child diet project in
For September I am still
planning to come to
letter confirms that the
Through contacts with Bob [Robert Pages] and Don [Donald Hoel], I understand we are all going to meet in
Enclosed please find a summary of the different projects which I think would be of interest for this meeting. I have not yet sent copies to Bob or Don as I would like your approval first concerning content and scope. Please let me know and I will make the necessary adjustments and additions and correspond directly with Bob and Don.
subjects his work – content and scope - to the double control of Philip Morris
and the lawyers of
summary of the different projects that is attached to the previous letter is a
two page document that lists six different activities, among which the
The Geneva Child/Diet/Respiratory Infection/ETS Exposure study has been completed in its first phase and the results are being evaluated. Correlations have been found between the number of cigarettes smoked by the mother and the incidence of bronchitis, but a stronger relationship was found between the same disease and consumption of certain vegetables. […] There is now a second planning phase in the study and a complete research protocol will be established towards the end of 1991. The project looks very promising as the first data suggest that diet factors may be of equal or even larger importance for children’s respiratory disease than ETS. (emphasis by the author)
14. It’s interesting to observe
that the project looks “promising” because diet factors reduce the importance of
ETS exposure. Rylander makes a
posteriori hypotheses on the observed correlation between diet factors and
infections. In all likelihood, the questionnaire applied by Rylander to his
subjects listed a great number of nutriment categories. Owing to the small size
of the population sample used in the study, the occurrence of associations
between some nutriments and the diseases under consideration is not surprising,
as there is a large probability that some associations be observed simply by
chance, without necessarily reflecting any underlying phenomenon.
visits the Philip Morris research center in
Thank you for a delightful
visit last week. I also had a very good session with Don [Hoel] and we covered a
variety of ETS related topics. In two weeks time I am off to
has obtained more money, of which he will assign the major part to the
As promised, I am enclosing herewith some articles relating to children’s health and nutrition. I hope you will find these of interest.
Morris lawyers seem to be very versatile, acting as scientific librarian.
Rylander could have obtained all the references he needed in
Thank you very much for the
references to child health and diet. This was most helpful. We are now reanalyzing data from
the same day, Rylander sends a fax to Osdene:
before last I took five working days in
says in other words that the data, which initially exhibited a correlation
between respiratory disease and exposure to ETS, have been corrected directly in
the database and now the correlation has vanished!
Hoel appears to be satisfied by this turn of events. On
I am attaching a copy of a
telefax message from Dr. Rylander.
As we discussed, Dr. Rylander is working on some very interesting data
from a study in
We note that for Hoel also,
the data has now become “very interesting”.
were no significant relationships between ETS exposure and any of the
by the author)
From that point on, this conclusion will remain an invariant assertion throughout the various stages of the project until it will appear in the article in Archives of Environmental Health and on the IMSP Internet site.
to what had been announced in his report of 30 August, there is no correlation
anymore with “certain vegetables”. Now it is eggs, chicken, yoghurt and milk
desserts that are at stake:
For diet factors, the strongest correlations were found between the consumption of eggs and cold (p=0.002), cough (p=0.017 and bronchitis (p=0.003). There was also significant relationship between these diseases and the consumption of chicken, yoghurt and milk desserts. No correlations were found between the diseases and consumption of vegetables.
see that the questionnaire was going quite deep in the level of details, being
able to distinguish milk desserts from yoghurts. Given the size of the sample
(90 children), we could imagine that the number of variables was not far from
the number of subjects in the study. Rylander therefore rightly warns his
readers that “the results are based on a food frequency questionnaire and the
results must be interpreted with caution”
However, in the next sentence, he himself seems to forget his own advice:
The data suggests, however, that there is a relation between consumption of certain proteins and the risk for respiratory infectious disease in children. Diet factors must be taken into consideration in studies on the relation between environmental agents and respiratory infectious disease in children. (emphasis by the author)
Given the high likelihood that
the observed correlations were random effects,
it seems premature to conclude that dietary factors “must” be taken into
account, considering that this requirement puts a heavy
burden on future studies.
a fax that he sends on
The data analysis of the
month later, we note a change in the choice of publication: it is no longer the
American Review of Respiratory
Diseases, it is now the European
Journal of Respiratory Diseases. Was the submission rejected? We do not
I intend to submit the article on childrens’ respiratory health for publication in the European J Respiratory Diseases. Unfortunately we have not yet been funded for the continuation of that study. When we last met, you indicated that there might be funding possibilities in the States. Do you have more information on this – I think that it is very desirable to expand the study to test the hypothesis developed from this first pilot test.
and in contrast to the way he presented it in the ATS abstract, Rylander
acknowledges that his first study is no more than a pilot test aimed at
developing hypotheses. This description is also opportune, because he now wants
more money to continue the study.
the beginning of 1992, Rylander goes to
will recall that questions on the number of siblings and attendance to day care
centers were included in our
Rylander acknowledges internally that exposure to ETS increases the risk of respiratory infection. In the same fax, he informs Osdene that:
to Europe, and following a conversation with Donald Hoel, Rylander sends him a
fax on 16 April 1992, in which he describes the status of three projects, among
which the one on children in Geneva:
2. Children and
pilot study performed among a sample of school children in
Luckily enough our study on childrens’ respiratory infections nutrition [sic] was ready a few weeks after I had written the editorial. The manuscript has been mailed to the European Journal of Respiratory Disease for publication. We are now doing a repeat of the latter study and the results will be available early July. Keep your fingers crossed.
The “keep your fingers crossed” is quite revealing.
now becomes, for a while, Rylander’s privileged counterpart at Philip Morris,
since Thomas Osdene, with whom Rylander had been in contact since the end of the
sixties and with whom he had a close and apparently very friendly relationship,
retired from Philip Morris at the end of May 1992. This may perhaps explain that
from that point in time on, the correspondence between Rylander and Philip
Morris is sparse.
year later, Rylander still reports to Don Hoel, as is shown in a fax that he
sends him on
Studies on smoking and health,
particularly cardiovascular disease and ETS related effects are plagued by the
presence of confounding factors. There is particularly strong evidence that diet
factors are important and that they covary with smoking making conclusions on
causal relationships with smoking very difficult. Many studies have not
controlled for all possible confounders.
A tradition down the workshop
trail would be to organize a meeting with the title “Smokers and non-smokers –
confounders I epidemiological studies” and systematically evaluate these factors
with recommendations to control them in future studies.
I would be very interested in
your comments and also information on where funding could be applied. If the
need arise we could meet in
To Hoel’s ears, a proposal aimed at “making conclusions on causal relationship with smoking very difficult” must sound like music. Rylander’s offer is indeed attractive. The symposium he proposes to organize would, in its conclusions, achieve two things in one go: on the one hand, it would essentially invalidate all previous studies on ETS on the ground that they did not take into account the multitude of confounding factors that “plague” ETS related effects, and, on the other hand, it would make all future studies much more difficult to conduct, since the burden of data collection of all these confounding factors would become almost prohibitive. This proposal provides an interesting clue on the context in which the study on children and respiratory diseases takes place.
previous fax is accompanied with a “Summary of joint research activities”, in
which one can read, notably:
The project on nutrition in
children and respiratory infections is discussed within the institute in
spite of Osdene’s retirement, the study on children and respiratory diseases
continues to be treated as a “joint project” between Philip Morris and Rylander.
the study seems to enter a dormant phase for a year and a half. We have to jump
The study on infection in children and diet is under way again and we should have results by early summer.
year later, on
The goal is to evaluate the
role of different environmental factors and the risk for respiratory infections
in children. One phase of the study has been completed and demonstrates that
breast feeding and mold/dampness in homes are the main factors. Exposure to ETS,
number of siblings and dietary factors were not associated with a risk. The
study continues in a prospective design with monthly follow up of the presence
of symptoms, controlling for the environmental agents.
still have the invariant assertion that seems to characterize the project
throughout its life cycle: “Exposure to ETS is not associated with a risk”. We
find the same description in an internal Philip Morris memorandum of
Environmental factors and
respiratory infections in children. Elaboration of questionnaires
with particular focus on dietary factors. Three field studies during the winter
months with subsequent modifications of the epidemiological technique. Planning
of extensive study to be initiated in the fall of 1997.
internal note dated
Rylander has been associated with Philip Morris for over 25 years, as a
consultant, as a scientist in charge of extra-mural research of the
transnational, in 1997 he still
makes notable efforts to preserve the appearance of independence, as
transpires in a candid letter that he sends on 23 June 1997 to Richard
Throughout the years I have
always been very strict to report to
internal note of Philip Morris USA dated 10 July 1997 from T. Banty to R.
Carchman informs us that “Dr. Ragnar Rylander signed a consultant agreement with
Philip Morris in 1972 […] as ‘our representative to INBIFO’”, and then lists his
current activities, which again include, for the period 1987-1996,
“Environmental factors and respiratory infections in children”.
The material from the original study is in manuscript form and additional data analysis are undertaken, following the suggestion of reviewers. It will be submitted for publication early 1998. The plans for an extended study were presented to the Swiss National Foundation for Medical Research but was [sic] not supported. Information is collected for a possible renewal of the request. The project is to [sic] large to be entirely funded by the present support from PMRD.
year later, on
The children & ETS related
topics are gaining ground in the public discussion and thorough papers are
pay to World Wide Consumer Bank,
has himself admitted in declarations to the press that this was his personal
Such mode of payment breaches the legislation of the University of Geneva, which
forbids university researchers to financially manage their research activities
using private bank accounts, whether in Switzerland or in other countries.
a letter dated
Philip Morris is pleased to
inform you that you grant entitled Childrens’ infections and Environmental
Agents has been recommended for the continuation of funding by our Scientific
Research Review Committee. We have also approved the final year of funding for
your grant entitled Magnesium and Cardiovascular Disease. A check in the amount
of USD $81'000 has been sent to the World Wide Consumer Bank in
We want to fund quality scientific research and to promote the independent investigation of the issues described in the grant.
Readers will appreciate the
statement concerning the desire to promote “independent” investigation.
the references cited in the paper, one observes a notable omission. No mention
is made of the SCARPOL study, which is the reference study on the subject in
research has been conducted at the request of CIPRET-Genève and OxyGenève, two
Swiss associations located in
 Acronym based on the French title, “Institut de médecine sociale et preventive”
 Text freely translated from French by the author. This is an uncertified translation.
 Ragnar Rylander and Ysabelle Mégevand, Environmental Risk Factors for Respiratory Infections, Archives of Environmental Health, September/October 2000 Vo. 55 No. 5 p.300-303.
 Ibid, p.302.
 B. Latal Hajnal et al.and the SCARPOL Team Effects of environmental tobacco smoke exposure on respiratory symptoms in children Schweiz Med Wochenschr 1999;129:Nr 19 pp 723-730
 Note that this is essentially the age group
considered by Rylander in his
 INBIFO - Inbifo Institut für biologische Forschung GmbH,
the research institute in
 PM 2023590213/0299 p.31; this document is among the documents released by Thomas Bliley and is found on the US House Committee on Commerce web site (http://docs.house.gov/tobacco/docs2/pmsearch.htm).
 CIAR – Center for Indoor Air Research, a trade
group created by the
 This presumption is reinforced by the fact that in their latest article, published in 2000 in Archives of Environmental Health (see above), Rylander concludes that dietary items were not associated with an increased risk for any of the diseases studied.
 From that point in time on, Richard Carchman appears to be Osdene’s successor as Rylander’s main contact person at Philip Morris USA.
 See article in
 See http://www.unige.ch/presse/communique/01-02/tabac.pdf
on the web site of the