The EPA Report
In December of 1992 the EPA released it's now famous report on second
hand smoke. The report claimed that SHS causes 3,000 deaths a year,
and classified it as a class A carcinogen.
Note: Although the official date of this report is December, 1992,
it is commonly referred to as the EPA '93 study, probably because it
became widely available in '93.
This was, and remains, a powerful weapon in the anti-smokers arsenal.
If a smoker is only hurting himself, he can argue that it's no one else's
business. But if he is hurting everyone around him, all kinds of restrictive
legislation can be justified.
Did this study show SHS is deadly? Let's examine the facts
Fact: In 1992 the EPA issued
a report which claimed that Environmental Tobacco Smoke (ETS) caused
3,000 deaths per year.
Fact: ETS is commonly referred
to as Second Hand Smoke (SHS). The two terms are interchangeable.
After reading each of the following facts, ask yourself "Does
this fact make the study more credible, or less credible?
Fact: The EPA announced the
results of the study before it was finished.
Fact: The study was a Meta
Analysis, an analysis of existing studies.
Meta Analysis is very difficult to do accurately, and is the easiest
kind of study to fake and manipulate. With a disease as rare as lung
cancer, leaving out just a few important studies can skew the results
(Approximately 87% of lung cancer occurs among primary smokers. Another 10% occurs in asbestos workers, leaving just 3% of the cases without an obvious cause.)
The term "Meta Study" is often used to describe this type
of report, but the word "study" is inaccurate. The EPA has never conducted
nor financed a single ETS study. They have only analyzed the studies
of others. It is more accurate to refer to it as an analysis, and to
its publication as a report.
Fact: The first step in a meta
analysis is identifying all of the relevant studies. The EPA located
33 studies that compared ETS exposure to lung cancer rates.
Fact: The EPA selected 31 of
the 33 studies. Later they rejected one of their chosen studies, bringing
the total to 30.
Fact: On page 3-46 of the report
the EPA estimates, based on nicotine measurements in non-smokers blood,
"this would translate to the equivalent of about one-fifth of a cigarette
that measured actual exposure by having non-smokers wear monitors indicate
even this low estimate is exaggerated. Actual exposure (for people who
live and/or work in smoky environments) is about six cigarettes per
year. (See also the study
by Oak Ridge National Laboratories.)
Fact: In 1995 The Congressional
Research Service (CRS) released a review of the EPA report.
The CRS was highly critical of both the EPA's methods and conclusions.
Fact: According to the CRS "The
studies relied primarily on questionnaires to the case and control
or their surrogates, to determine EST exposure
and other information pertinent to the studies."
Questionnaires can be notoriously inaccurate, as discussed in Statistics
102, but in this case some of them were not even filled out by
the people being studied, but by "surrogates." In other words, some
of the information was unverified hearsay.
Fact: On page 23 of the study,
paragraph 3, the CRS noted that out of 30 studies, only five found
a statistically significant risk at the 95% confidence level, and one
showed a statistically significant negative risk (a protective effect).
The remaining 24 studies showed no statistically significant increase
or decrease in risk.
Fact: Three other large US studies
were in progress during the EPA's study. The EPA used data from one
uncompleted study, the Fontham study, and ignored the other two, Brownson
Fact: The Fontham study showed
a small increase in risk. The CRS report referred to it as "a positive
risk that was barely statistically significant." (p. 25)
Fact: The CRS report said the
Brownson study, which the EPA ignored, showed "no risk at all." (p.25)
Fact: The "scientists" who
conducted the Fontham study refused to release their raw data for
years. They were finally forced to when Philip Morris won
a lawsuit to gain access to it.
Most researchers routinely make their raw data available after studies
have been published. Does Fontham's refusal to make the data available
make them more credible, or less credible?
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Fact: The EPA based their numbers
on a meta analysis of just 11 studies. The analysis showed no
increase in risk at the 95% confidence level.
Fact: Even after excluding
most of the studies, the EPA couldn't come up with 3,000 deaths, but
they had already announced the results. So they changed the CI to
90%, which, in effect, doubled their margin of error.
Fact Worth Repeating: Instead
of using the 95% confidence interval, the statistical standard that
has been used for decades, the EPA doubled their margin of error to
achieve their pre-announced results.
Would any legitimate epidemiologist keep their job if they were caught
doubling their margin of error to support a pre-announced conclusion?
Fact: After juggling the numbers,
The EPA came up with an RR (Relative Risk) of ETS causing lung cancer
1.19. In layman's terms that means:
Exposure to the ETS from a spouse increases the risk of getting
lung cancer by 19%.
Where you'd usually see 100 cases of cancer you'd see 119.
Fact: A RR of less than 2.0
is usually written off as an unimportant result. An RR of 3.0 or
higher is considered desirable. (See Statistics
101 for more details.)
This rule is routinely ignored when the subject is second hand smoke.
Facts: In review: The EPA ignored
nearly two-thirds of the data. The EPA then doubled their margin
of error to come up with their desired results.
Fact: Although the EPA declared
ETS was a Class A carcinogen with an RR of 1.19, in analysis of other
agents they found relative risks of 2.6 and 3.0 insufficient to justify
a Group A classification.
Fact: In 1998 Judge William
Osteen vacated the study - declaring it null and void after extensively
commentating on the shoddy way it was conducted. His decision was 92
Fact: Osteen used the term "cherry-picking"
to describe he way the EPA selected their data. "First, there is
evidence in the record supporting the accusation that EPA
"cherry picked" its data. Without criteria for pooling studies
into a meta- analysis, the court cannot determine whether the exclusion
of studies likely to disprove EPA's a priori hypothesis was coincidence
or intentional. Second, EPA's excluding nearly half
of the available studies directly conflicts with EPA's purported
purpose for analyzing the epidemiological studies and conflicts with
EPA's Risk Assessment Guidelines."
Fact: Osteen found other deep
flaws in the the EPA's methodology. In his judgment he stated: "The
record and EPA's explanations to the court make it clear that using
standard methodology, EPA could not produce statistically significant
results with its selected studies. Analysis conducted with a
.05 significance level and 95% confidence level included relative risks
of 1. Accordingly, these results did not confirm EPA's controversial
a priori hypothesis. In order to confirm its hypothesis, EPA maintained
its standard significance level but lowered the confidence interval
to 90%. This allowed EPA to confirm its hypothesis by finding a relative
risk of 1.19, albeit a very weak association. EPA's conduct raises several
concerns besides whether a relative risk of 1.19 is credible evidence
supporting a Group A classification. First, with such a weak showing,
if even a fraction of Plaintiffs' allegations regarding study selection
or methodology is true, EPA cannot show a statistically
significant association between ETS and lung cancer."
Fact: The following is another
direct quote from Judge Osteen's decision: "In this case, EPA publicly
committed to a conclusion before research had begun;
excluded industry by violating the Act's procedural requirements; adjusted established procedure and scientific norms to validate
the Agency's public conclusion, and aggressively utilized the
Act's authority to disseminate findings to establish a de facto regulatory
scheme intended to restrict Plaintiffs, products and
to influence public opinion. In conducting the ETS Risk Assessment,
disregarded information and made
findings on selective information; did not disseminate significant
epidemiologic information; deviated from its Risk Assessment Guidelines;
failed to disclose important findings and reasoning;
and left significant questions without answers.
EPA's conduct left substantial holes in the administrative record. While
so doing, produced limited evidence, then claimed the weight of the
Agency's research evidence demonstrated ETS causes cancer. Gathering
all relevant information, researching, and disseminating findings were
subordinate to EPA's demonstrating ETS a Group A carcinogen."
Most of the media ignored the judge's decision.
When confronted with this decision, many anti-tobacco activists and
organizations harp on the fact that Judge Osteen lives in South Carolina.
The obvious implication is that he's influenced by the tobacco industry
in his state. It may also be an appeal to the "stupid southerner" stereotype.
Fact: Judge Osteen has a history
of siding with the government on tobacco cases.
Fact: In 1997 Judge Osteen
the FDA had the authority to regulate tobacco.
So much for his alleged bias.
Fact: Although this study has
been thoroughly debunked by science and legally vacated by a federal
judge, it is still regularly quoted by government agencies, charity
organizations and the anti-smoking movement as if it were legitimate.
Fact: Anyone referring to EPA
classifying ETS as a Class A carcinogen is referring to this study.
Opinion: You should seriously question the credibility of anyone
who refers to this study, or any of the conclusions that it reached,
as if they were facts. That includes everyone who refers to the EPA's
ruling that ETS is a Class A Carcinogen. Once they do, every subsequent
statement they make should be considered highly suspicious until it
is thoroughly verified.
Fact: Most of the information
on this page was gleaned from Judge Osteen's 92 page decision, the
CRS report, and the EPA's study.
Fact: The EPA fought to have
Osteen's decision overturned on technical grounds. They succeeded in
2002 on the narrowest of technicalities. The fourth circuit court of
appeals ruled that because the report was not an official policy
document Osteen's court did not have jurisdiction.
Fact: In their appeal the
EPA did not answer a single criticism on the 92 page report, nor challenge
a single fact put forth by Judge Osteen. Not one.
You are strongly encouraged to read these documents yourself. You
can find the judge's entire decision here.
The CRS report is available here.
The EPA report over six hundred pages long, and we recommend you order
a hard copy. It is available to US citizens at no charge. Call (800)
438-4318 and ask for document EPA/600/6-90/006F. The title of the
report is "Respiratory Health Effects of Passive Smoking: Lung
Cancer and Other Disorders." It is also available as on line
as a pdf
file. Note: this is a four megabyte file.
Fact: Carol Browner, the former
head of the EPA, still insists that this study is valid!
The Smokers Club Inc. has complied a wealth of articles about
this study and other shenanigans by the EPA.
Enough facts, already. Now for some opinions:
Zion, in the New York Daily News
Times on the EPA's agenda