Philip Morris
'health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children' Notes on the Meeting of the US Environmental Protection Agency (Epa) Science Advisory Board (Sab) to Consider the External Review Draft Held at Crystal City, Washington Dc on 901204 and 901205
Fields
- Author
- Lee, P.N.
- Area
- LEGAL DEPT/EEMA ARCHIVE
- Document File
- 2501073421/2501073557/Ets General 900000 - 910000 Eema Legal Dpt.
- Type
- REPT, REPORT, OTHER
- Named Organization
- Americans for Nonsmokers Rights
- American Cancer Society
- Centers for Disease Control
- Ciar, Center for Indoor Air Research
- Coalition on Smoking or Health
- Doctors Ought to Care
- Epa Board
- Epa, Environmental Protection Agency
- Harvard
- Hri, Health Research Inst,Roswell Park
- Iarc
- Nrc
- RJR, R.J.Reynolds
- Science Advisory Board
- TI, Tobacco Inst
- Washington Post
- Women Vs Smoking Network
- 1990 World Smoking + Health Conference
- American Cancer Society
- Site
- E35
- Named Person
- Aviado
- Axelrad
- Bayard, S.
- Benowitz
- Blot
- Brown, K.
- Burns, D.
- Butler, W.J.
- Clayton
- Crawfordbrown, D.
- Cummings
- Curvall
- Davis, D.L.
- Debethizy
- Dockery
- Doll
- Farland, W.H.
- Flaak, R.
- Flamm
- Fleiss, J.L.
- Garfinkel
- Gibbons, J.D.
- Giovani
- Glantz, S.A.
- Gori, G.
- Gross, A.J.
- Haley, N.
- Hammond
- Hiller
- Hirayama
- Hoffmann
- Hood
- Houston
- Howard, G.
- Huber, G.L.
- Humble, C.
- Idle
- Janerich
- Kabat, G.
- Katzenstein, A.W.
- Kilpatrick, S.J.
- Knudson
- Koppikar, A.
- Laties
- Layard, M.
- Lee, P.N.
- Levois, M.
- Lewtas, J.
- Lippmann
- Lopez
- Lowrey
- Makosky
- Mantel, N.
- Moolgavkar
- Okeeffe
- Parrish
- Peto
- Pettiti
- Poland, T.M.
- Reasor
- Repace
- Ritchie
- Robertson
- Rockette
- Rosenbaum, W.L.
- Sanet
- Schneider, B.
- Shimizu
- Sobue
- Springall, A.
- Sterling, T.D.
- Stewart
- Surgeon General
- Switzer, P.
- Thorslund, T.
- Trichopoulos
- Tweedie, R.
- Uberla, K.
- Varela
- Wald
- Weinkam, J.J.
- Wells, A.J.
- Will
- Williams
- Witorsch, P.
- Witorsch, R.
- Wu
- Wynder, E.
- Axelrad
- Attachment
- 2501073503/2501073556
- Master ID
- 2501073503/3556
Related Documents:- 2501073503
- 2501073529 U.S. Environmental Protection Agency Science Advisory Board Indoor Air Quality and Total Human Exposure Committee (Iaqthec) Environmental Tobacco Smoke Review
- 2501073530-3532 U.S. Environmental Protection Agency Science Advisory Board Indoor Air Quality and Total Human Exposure Committee Environmental Tobacco Smoke Review Final Draft Agenda
- 2501073533-3535 Science Advisory Board Review of the Draft Report 'health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children.' Epa/600/6-90/006a
- 2501073536-3555 Draft Talk to Epa Sab
- 2501073556 Passive Smoke A Cause of Cancer, Panel Concludes Epa Told Risk of Respiratory Illness in Children Also Increased by Involuntary Exposure
- Litigation
- Stmn/Produced
- Date Loaded
- 31 Jan 1999
- UCSF Legacy ID
- xhi33e00
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"Health Effects of Passive Smokinz:
Assessment of Lung Cancer in Adults
and Respiratory Disorders in Children"
Notes on the Meeting of the
US Environmental Protection A encv (EPA)
Science Advisory Board (SAB)
to consider the External Review Draft
held at Crystal City, Washington DC on
4 and 5 December 1990
Author : P N Lee
Date : 9.12.90
1. Backg.round
Earlier in the year the EPA had circulated for public comment a
draft document entitled "Health Effects of Passive Smoking:
Assessment of Lung Cancer in Adults and Respiratory Disorders in
Children" and also a further draft document entitled "Environmental
Tobacco Smoke (ETS): A Guide to Workplace Smoking Policies". The
principal points to note in the main document were that:
(i) It concluded based on the epidemiological evidence on spouse
smoking and lung cancer that ETS was a Group A Carcinogen,
i.e. an agent known to cause cancer in humans).
(ii) It estimated that annually 3800 deaths a year from lung cancer
in the USA among never and ex-smokers were the result of
exposure to ETS, with 95% confidence limits cited as
1800-6100. 2501073504
-2-
(iii) It concluded that exposure of young children to ETS from
parental smoking, particularly during infancy, is associated
with increased prevalence of acute lower respiratory tract
infections, respiratory symptoms of irritation, middle ear
effusions and reduced lung function, growth and pulmonary
development.
(iv) It did not include deaths from other cancers, heart disease,
non-neoplastic respiratory disease in adults, or from other
causes in its risk assessment, considering that evidence of a
causal relationship had not been demonstrated.
Although EPA has no regulatory power to limit exposure to ETS,
the document, when finalised, would carry great weight when
attempting to bring in new laws in US states.
The main purpose of the meeting in Crystal City was for the
EPA to receive public comments and comments from the SAB on the
draft so that they could either finalize the documents or perhaps
resubmit a further draft to go through the comment procedure.
Apparently EPA were actually under no obligation to ask for the
SAB's advice or to act on it, but in practice they usually did take
account of it. The documents could in fact not be finalized until
they had been approved by a higher Committee (which met 3-monthly)
after which they would become official EPA publications.
The EPA had already received over 3000 pages of comments from
over 100 individuals on the draft. At the meeting they promised
they would provide a considered reply to the
comments, but the level
of detail this would go into was unclear. As I understood it the
-3-
written comments
had not gone in full to the board, although each
board member was sent by the Tobacco Institute a set of
presentations to the SAB. This consisted of a volume giving 13
primary submissions on the ETS Lung Cancer Risk Assessment, a volume
giving 3 submissions on the ETS Workplace Policy Guide and 7
Appendix Volumes giving the full texts of comments mainly by those
who would be speaking or who had provided primary submissions. With
the exception of Richard Tweedie's material from Australia, I was
the only non US based consultant used by the Institute. I had
provided a 12 page summary of
my main comments (which related to
lung cancer) in the primary submissions, and a commentary of some 38
pages, with Annexes which included my draft book on ETS and my draft
paper on risk assessments in the Appendix Volumes.
The Tobacco Institute had also provided a press release (for
the day before the meeting) which outlined some of the flaws in the
report. It also included a summary paragraph for each of the
comments of all the people who had filed documents critical of the
draft EPA ETS risk assessment.
I have in my possession, for those who are interested, copies
of:
1) The TI primary submissions volume 1, which includes comments by
de Bethizy (Overall), Reasor/Will and Aviado
(Toxicology/Chemistry/Dosimetry), LeVois/Layard, Tweedie and
Lee (ETS Epidemiology General), Butler (Confounding),
Fleiss/Gross, Tweedie, Howard and Switzer (Meta-analysis),
Flamm (Regulatory Aspects), and Hood/R. Witorsch/P. Witorsch
(Childhood Respiratory Diseases). 2501073506
-4-
2) The TI press release
3) Detailed submissions of:
W J Butler
J L Fleiss and A J Gross
J D Gibbons
S A Glantz
G Gori
A J Gross
N Haley
G L Huber
A W Katzenstein
S J Kilpatrick
M Layard and M LeVois
N Mantel
R J Reynolds Tobacco Company (including Appendix by Dr George
Howard)
B Schneider
A Springall
T D Sterling, J J Weinkam, W L Rosenbaum and T M Poland
P Switzer
R Tweedie
K Uberla
A J Wells
E Wynder
I also of course have copies of the original draft reports, and
my own submissions, including a later commentary on Wells'
submission. The only paper presented at the meeting which I have
copies of is that by A J Wells, although I am on a mailing list for
copies of other materials. Ultimately a transcript of the whole 2
days will become available.
A list of the SAB members is attached as Annex A, with the
agenda attached as Annex B. Annex C is a copy of the official
letter requesting advice from the SAB. It includes 8 questions
relating to lung cancer in adults and 3 questions relating to
-5-
1)
respiratory disorders in children on which the SAB's advice was
particularly sought. I also have a copy of a document summarizing
what is known about the board members and their views on smoking and
ETS.
A red herring
Before the meeting there had been allegations in the press that
members of the Board had been "bought" by the industry. Some of
these allegations arose out of the fct that some SAB members had
conducted peer reviews for the CIAR (The Centre for Indoor Air
Research set up a couple of years ago by inter alia parts of the
tobacco industry) and had received money for this. The net result
of all this was that the 100 or so of us who were present had to
waste an hour while every board member related all his work on
tobacco and ETS and who had provided funding and to whom. There was
in fact no indication that the SAB were biassed towards industry,
rather the reverse as one of the members, Dr David Burns, was well
known for his militant anti-smoking beliefs. It was a pity no-one
made the simple point that when considering an industry's problems
it helped to have scientists who actually knew something about the
subject. As most research on an industry's problems was generally
paid for by that industry, one really had to ask whether restricting
attention to squeaky-clean ignorami, however intelligent, was really
desirable. To his credit the chairman of the SAB did point out that N
[A
there were a lot of knowledge gaps and that the CIAR work was very 0
O
useful, given EPA only have a budget of 3 mn. dollars a year for ca
Cn
0
indoor air research, only 30-40% of which is on ETS. OD
I
-6-
3. Introductory talks by the EPA
Atielrad pointed out that the EPA's policy guide was not
dependent on the ETS risk assessment. Their view was that, even in
the absence of complete scientific data, "it is prudent to minimize
exposure to indoor pollutants". They also could have relied on the
"credible" reports of the Surgeon-General and the NRC. However they
felt their policy guide would carry more weight if they evaluated
the ETS studies since 1986, quantified the extent of risk and made a
classification of ETS as a carcinogen.
He also noted the EPA had received 115 submissions on time and
23 late and that they would be preparing a detailed response
document.
Steve Bayard who was the EPA project officer in charge of the
ETS work noted the people who had prepared the various sections of
the draft risk assessment. Kenneth Brown had been responsible for
the epidemiological assessment, the meta-analysis, the risk
assessment, and Appendix B which gave relevant mathematical formulae
relating to the adjustment for smoking habit misclassification.
Charles Humble had prepared Appendix A, which provided a detailed
summary and analysis of the post-1986 case-control studies of ETS
and lung cancer. Douglas Crawford-Brown had prepared Appendix C,
which discussed the dosimetry of ETS, while Todd Thorslund had
prepared Appendix D, which described a potential framework for
dose-response modelling for ETS and lung cancer. Advice had also
been received by Joellen Lewtas and Agatha Koppikar. Bayard noted
-7-
their estimate of 3800 deaths per year was incorrect due to a
typographical error! The correct figure should have been 3700!! His
discussion on the difficulties of interpreting the ETS epidemiology
and the meta-analysis was rambling and often incoherent (at one
stage Lippmann told him to
speed up and get to the point). Amazingly
he cited evidence from a 1990 paper by Wu-Williams and Sanet (an SAB
member) of a significant dose-related trend from the overall
proving a cause and effect relationship!
data as
Thorslund briefly presented his dose-response model fitting
work. Based on data from Doll and Peto and from Hammond he fitted
the Moolgavkar-Knudson model to obtain a mathematical relationship
between lifetime cancer risk and number of cigarettes per day given
age of starting and stopping. If one plugged in ;i to 1 cigaretts
per day which he (totally unreasonably) felt was appropriate for the
cigarette equivalent for ETS exposure, then one ended up with risk
predictions consistent with the epidemiology. He then gave
estimates of risk in extreme situations, including an absurd figure
of a lifetime risk of over 50% of lung cancer for a heavily ETS
exposed individual who was an extensive metaboliser of debrisoquine.
Koppikar discussed briefly the evidence on respiratory disease
in children. When mentioning sources of bias it was notable that
she totally failed to refer to transmission of infection or
confounding by social class.
2501073510
-8-
Brown, who had written the key part of the document, had
clearly read my detailed submission as he referred to it a number of
times. He presented some slides in which he had included data from
studies that had been omitted from the report - most notably the
large US case-control study of Varela and Janerich, but also the
studies of Shimizu and Sobue and the second study of Kabat.
He
presented estimates based partly on data in my report and partly
using misclassification corrections provided by Wells showing that,
whereas the Asian studies showed a statistically significant
increased risk in relation to spouse smoking (relative risk 1.37,
95% limits 1.17-1.61), the US studies did not (relative risk 1.02,
95% limits 0.80-1.28). He did not comment on the fact that
essentially all the data on misclassification came from Western
populations so that the Asian relative risk estimates were highly
dubious.
Presentations by industry
The intention had been for there to be 12 presentations. By
the time Parish, de Bethizy, LeVois, Tweedie and Butler had
talked, we were then told we only had half an hour left. After
discussion it was agreed that we would drop Clayton, Witorsch and
Robertson, concluding with Switzer, Fleiss, myself and Flamm. In
practice this made little difference as there was very small direct
response of the SAB to points made and there were written
submissions anyway. The basis of my own presentation, including
slides, is attached as Appendix D, though in practice I modified it
2501073511
-9-
somewhat to comment on points already raised. I will not describe
the points made by the other speakers here, although I will refer to
some issues in section 8, "Questions of interpretation". Generally
the great majority of what was said came over as reasonable,
although the extent to which the points will be taken up is open to
question.
5. Presentations by coalition on smoking or health
Trichopoulos, now Professor of Epidemiology at Harvard, went
through some of the issues of interpretation. He contrasted the ETS
situation with that of alar, use of which was banned without any
real evidence, and with that of fat in diet, reduction of which
was national policy, based on evidence no stronger than that for
ETS. Although his talk purported to be an academic discussion of
issues of interpretation, there were major omissions (any mention
of smoking habit misclassification bias) and major distortions (only
advantages of using Asian data in meta-analysis were cited, with no
mention of the very relevant disadvantages - see section 8).
Garfinkel, who has now retired from the American Cancer
Society, was very disappointing. I had half expected him to present
a whole lot of new results from the two huge Cancer Prevention
Studies. Instead he only described results from his 1981 and
particularly his 1985 lung cancer studies. I had heard him give
this talk about 3 times before!
2501073512
I
-10-
Dockery gave an extremely superficial view of the ETS evidence.
Essentially he was saying that because there was a preponderance of
positive lung cancer relative risks
in relation to spouse smoking,
because the confidence limits didn't indicate any obvious
inconsistencies between the studies, and because according to his
funnel plot analysis there was no suggestion of publication bias, it
was clear that ETS caused lung cancer. There was no discussion of
various relevant sources of potential bias.
6. Public comments
Devra Lee Davis, who was involved in the NRC report, quoted
estimates of Lopez and Peto that active smoking caused 3 mn. deaths
a year worldwide now, predicted to rise to 10 mn. in 30 years time.
She offered the SAB copies of the NRC report (it tells one a lot
that some didn't have it already!) and emphasized the children's
data, drawing attention to evidence of effects of paternal smoking.
Cummings of Roswell Park Cancer Institute in Buffalo, New York,
presented evidence from his own studies of cotinine levels in
smokers, non-smokers married to smokers, and non-smokers married to
non-smokers. His data showed low levels of smoking habit
misclassification, low levels of between spouse smoking habit
concordance and a relatively high level of cotinine in non-smokers
married to smokers. I will refer to these data, which considerably
increase uncorrected relative risk estimates, in section 8.
