The current scientific evidence does not support the conclusion that environmental tobacco smoke (ETS) is a lung carcinogen in humans, according to a new risk assessment published by an independent panel of six senior European scientists.

The European Working Group on Environmental Tobacco Smoke and Lung Cancer conducted a full evaluation of the relevant epidemiological and biological literature in what is believed to be the most extensive study of its kind.

"This group brought together recognized experts from the fields of genetics, biochemistry, nutrition, statistics, clinical and molecular sciences to conduct an exhaustive risk assessment on ETS and lung cancer," said professor Jeffrey Idle, professor in medicine at the Norwegian University of Science and Technology, Trondheim, and chairman of the European Working Group. "Having considered the weight of the evidence, it is the judgement of the Working Group that environmental tobacco smoke is not a primary lung carcinogen," Professor Idle said.

Evaluation of Epidemiological Studies on ETS

The European Working Group analyzed all 48 epidemiological studies on ETS and lung cancer published world-wide. Evaluating the so-called spousal studies (mostly among non-smoking women who live with men who smoke ), the Group concluded a relative risk of lung cancer for non-smokers of 1.01 -- based on the U.S. studies, the largest homogenous group. The Group's evaluation of studies on workplace smoking put relative risk from ETS in the workplace at 1.04. Neither of theses risk estimates was statistically significant.

"A relative risk of 1.0 means a zero increase in risk, and relative risks of 1.01 and 1.04 are virtually meaningless in scientific terms. They are no different from a zero increase in risk, Professor Idle said. Most scientists believe that relative risks below 2.0 are generally inconclusive.

Evaluation of Exposure to ETS

The European Working Group also found that in everyday settings, where levels of ETS have actually been measured, only a few compounds present in tobacco smoke have been detected because of their extremely low concentrations.

" We were very surprised at the extremely low levels of exposure to chemicals from ETS. With the aid of a straightforward calculation, we found that the concentration of ETS constituents is consistently lower than the levels of the same individual chemicals permitted in the workplace -- ten to one million times lower, " Professor Idle said.

The report also stressed the role of lifestyle. " Exposure to ETS is most unlikely to be a significant risk for lung cancer in humans because, compared to such a low level of exposure to chemicals, other common lifestyle risk factors are likely to play a more significant role."

Evaluation of Biological Plausibility

The panel of scientists also evaluated the claim that ETS is a lung carcinogen because it is similar to the cigarette smoke inhaled by smoking. But, according to the report, " Often an unfounded assumption regarding the similarity between ETS and either mainstream or sidestream smoke is used to justify an argument between biological plausibility. The report suggests that such an assumption is inappropriate."

The European Working Group's report concluded: "Our findings are entirely consistent with there being no elevated risk of lung cancer by exposure to ETS at work or in the home, either from a smoking parent or spouse."

The study was commissioned by three tobacco companies -- Phillip Morris Europe S.A., British- American Tobacco Company Limited, and Rothmans International Services Limited -- to evaluate published claims on the relationship between ETS and the risk of lung cancer.

The European scientists agreed to conduct the study on the condition that their work remained free of interference from the funding organizations. The Working Group reserved the right to publish their findings regardless of the outcome.

Editors note:

The European Working Group was chaired by Professor Jeffrey Idle. Other members are Professor Hans Krokan, The Norwegian University of Science and Technology, Trondheim; Professor Julio Benitez, University of Extremadura, Badajoz,Spain; Professor Paul Lohman, Lieden University, The Netherlands; Professor Marcel Roberfroid, Universite Catholique de Lovain, Belgium; Dr. Anthony Springall, independent statician, Clevedon, UK.

The full report is available from Micheal Johnson, 24-28 Bloomsbury Way, London WC1A 2PX, telephone: 0044171 831 6262.

Summary Points

• The working group is composed of six distinguished independent scientists from five countries who conducted a risk assessment to evaluate whether there is a risk of lung cancer associated with exposure ETS.

• Our views and comments on the report are preliminary since it was just released and we have not had the opportunity to review it in detail.

• The reports conclusions appear to be broadly consistent with our view that there is no elevated risk of lung cancer associated with ETS.

• This independent report was commissioned by Phillip Morris Europe S.A. and other tobacco companies in response to a growing controversy about ETS. The founders had no input into the findings.

Key Findings

• The Working Group evaluated 48 epidemiological studies on ETS and concluded " there exists insufficient evidence to endorse the view that ETS is a primary lung carcinogen."

• The Working Group performed a number of calculations which show virtually no increased risk associated with lung cancer from exposure to ETS

- The panel analyzed all comparable workplace studies and calculated a relative risk of 1.04

- The panel also analyzed all comparable spousal studies ( non-smoking women who live with smoking men ) and calculated a relative risk of 1.01, based on the U.S. studies, the largest group.

• The report states that levels of ETS constituents to which non-smokers are exposed are extremely low. The Working Group " found that the concentration of ETS constituents is consistently lower than the levels of the same individual chemicals permitted in the workplace - ten to one million times lower".

• The Working Group concluded that, " exposure to ETS cannot be equated to active smoking. The extrapolation from active smoking to ETS exposure is therefore a fruitless exercise."

• The report emphasizes the need to accurately account for various confounders such as diet, lifestyle and occupational exposures which can significantly affect the outcome of epidemiological studies on the association between ETS and lung cancer.

• The report points out that previous studies have not adequately corrected for so-called smoker misclassification. Study subjects who claim to be non-smokers may sometimes be smokers which can significantly affect the outcome of the studies.

In the judgement of the Working Group " it is beyond the limits of current science to conclude that ETS exposure significantly adds to the risk of human lung cancer."

Preface ______________ News Release Key Message Points ______ About the Working Group

Questions and Answers

European Working Group on Environmental Tobacco Smoke and Lung Cancer

1. Who Financed The European Working Group on ETS and Lung Cancer?

The Study was commissioned by three tobacco companies -- Phillip Morris Europe S.A., British- American Tobacco Company Limited, and Rothmans International Services Limited.

2. Doesn't this mean the Working group is not really independent?

Absolutely not, the members of the Working Group are senior scientists with the highest professional credentials. The members have worked with the leading international scientific bodies/health organizations. Look at their actual background and experience. (see bios attached).

3. Certainly the objectivity of the report and its findings can be questioned. How far did the tobacco industry influence the report's findings?

At no time and in no way did any of the tobacco companies influence or seek to influence the European Working Group's work and conclusions. In fact, none of the companies commissioning the report have met with any of the scientists. The Working Group reserved the right to publish their findings regardless of the outcome.

4. Isn't it true that you picked scientists who have previously worked for the tobacco industry to conduct this risk assessment?

The three tobacco companies did not select the scientists. The panel was convened by the chairman, Professor Jeffrey Idle bringing together leading scientists with experience various fields such as toxicology, genetics, biochemistry, nutrition, statistics, clinical and molecular science so that acomprehensive risk assessment could be conducted. See question 3.

5. Why did you commission this report? And why now?

Since the EPA's report in 1992 - which we disputed - many studies have been published on ETS and Lung Cancer. Our company position has always been that the scientific evidence demonstrated as a whole does not demonstrate any increased risk of lung cancer associated with Environmental Tobacco Smoke (ETS).
To date there are over 48 separate reports and studies published with varying methodology and results. We felt that the public interest would be served by a thorough independent review of all scientific evidence.
This comprehensive risk assessment on ETS and lung cancer concludes that " there exists insufficient evidence to endorse the view that ETS is a primary lung carcinogen."
We hope that regulators and businesses will take this risk assessment into account when developing smoking policies.

6. How much do you pay each scientist?

I believe we provided the normal constituency fee. As a matter of policy we do not disclose anyfigures.

7. Who paid for the publicity; of the report, i.e. the press conference, the translations etc.?

The panel members took the initiative to make the results public. The companies supported their efforts to publicize the results.

Preface ______________ News Release Key Message Points ______ Questions and Answers

About The Working Group

Professor Jeffrey R. Idle, PhD, Cchem, FRSC, is Professor in Medicine and Molecular Biology at the University of Science and Technology, Trondheim, Norway. He is currently a Consultant in Clinical Genetics; and the Founding Editor, Editor -in- chief of the Journal Pharmacogenetics, one of the highest ranking pharmacology journals currently published; and serves on the Cancer Research and Advancement Board of the Irish Cancer Society. He has been a WHO Special Advisor and Committee Chairman; has over 20 years experience in metabolism and disposition of chemicals in man and animals, and is the author of more than 300 scientific papers.

Professor Idle is internationally recognised as the first scientist to associate a particular gene polymorphism with susceptibility to lung cancer. In his role as Chairman, he brings to The Working Group a background in chemical toxicology and bimolecular analysis, gene polymorphisms related to disease susceptibility, and the understanding of disease mechanisms from a genetic viewpoint.

Professor Hans E. Krokan, MD,PhD is a Professor of Medicine at the UNIGEN Centre for Molecular Biology,at the University of Science and Technology, Trondheim, Norway. He is currently chairman of the program committee for gene technology and molecular biology within the Research Council of Norway -- division of Medicine and Health; chairman of the Advisory Committee of Biotechnology -- the Research Council of Norway; and a member of the review committee for the Norwegian Cancer Society. He has been president of the Norwegian Biochemical Society and director of the UNIGEN Centre for Molecular Biology. He is the author of more than 70 scientific papers and the editor of several books concerning DNA repair after exposure to UV radiation and geneotoxic chemicals.

Professor Krokan is internationally recognised for his work on DNA repair genes. His group was the first to isolate and characterize UDG, a DNA repair gene. He brings to the Working Group clinical expertise and a detailed understanding of the relationship between chemical exposures, DNA events and carcinogenesis.

Professor P H M Lohman, PhD, is Professor and Director of Laboratory of Radiation Genetics and Chemical Metagenesis at the University of Leiden. He is currently a member of the Dutch National Health Council; Executive Managing Editor of the journal Mutation Research; a member of the EEC Radiation Protection Commission; vice-chairman International Commission for Protection Against Environmental Mutagens and Carcinogens and a councillor to the US Environmental Mutagen Society. He has been president of the Dutch Toxilogical Society; president of the European Environmental Mutagen Society; deputy chairman and secretary to the Mutagenicity Committee of the Dutch National Health Council. He is the author of more than 150 scientific papers and the editor of several books.

Professor Lohman is internationally recognised for his work on the relationship between radiation and chemical exposures, damage to DNA and disease outcomes. He brings to the Working Group a strong background in risk assessment, a thorough knowledge of genetic toxicology and a perspective on population risks for disease.

Professor Marcel Roberfroid, PhD, is Professor in the department of Pharmaceutical Sciences, Universite Catholique de Lovain, Belgium. He is currently on the Editorial Board of several international journals in the field of cancer research and toxicology and the Editor of the journal Food and Chemical Toxicology. He founded the European Research Group for Alternatives to Toxicology Testing (ERGATT) and has served as an external expert for the International Agency for Research in Cancer. He is the author of more than scientific papers.

Professor Roberfroid has been acclaimed in the international arena for his work on nutrition, functional foods and health outcomes. He brings to The Working Group a strong toxicological background and a thorough understanding of the impact of nutrition on the process of carcenogenersis. He is familiar with risk assessment procedures and has served on various committees for this purpose.

Dr. Anthony Springall, PhD, Cstat is a fellow of the Royal Statistical Society, and independent consultant in statistics. A former Principal Lecturer at the University of the West of England, he has applied his statistical knowledge to numerous areas of research, particularly in industrial settings, having worked for Imperial Tobacco and Unilever. He has served on various local and national committees, including the Council of the Royal Statistical Society.

Dr. Springall brings to the Working Group expertise in the application of statistics to many areas of practical research. For many years he has studied the published reports claiming to associate Environmental Tobacco Smoke with lung cancer.