Report on
Epidemiological Studies, Court Cases
FACT:
The Congressional
Research Service (CRS) in its 1995
report to Congress found flaws
in the Environmental Protection Agency's (EPA)
report as did William L. Osteen, United States
District Judge, who, on July 17, 1998, said in
his decision:
"EPA publicly committed to a
conclusion before research had begun;
excluded industry by violating the (Radon
Research) Act's procedural requirements; adjusted
established procedure and scientific norms to
validate the agencies' public conclusion, and
aggressively used the Act's authority to
disseminate findings to establish a de facto
regulatory scheme intended to restrict
Plaintiff's products and to influence public
opinion.
"The
Court is faced with the ugly possibility that EPA
adopted a methodology for each chapter, without
explanation, based on the outcome sought in that
chapter.
"Using its normal methodology and its
selected studies, EPA did not demonstrate a
statistically significant association between ETS
(secondhand smoke) and lung cancer. This should
have caused EPA to re-evaluate the inference
options used in establishing its plausibility
theory. A risk assessment is supposed to
entail the best judgment possible based upon the
available evidence. (See Ethyl, 541 F.2d
at 24.) Instead, EPA changed its
methodology to find a statistically significant
association.
(Click here
for Judge Osteen's decision)
FACT:
The EPA fought
this ruling, and the United States Court of
Appeals for the Fourth Court vacated Judge
Osteen's decision on Dec. 11, 2002, ONLY
on the grounds that NO court had
jurisdiction over the EPA report. The Court
of Appeals also questioned the EPA
excluding any industry representative from the
advisory committee.
(Find PDF file of court ruling at:
http://pacer.ca4.uscourts.gov/
opinion.pdf/982407.P.pdf)
FACT:
Anti-smoking
advocates cite the following number: 53,000
deaths a year from secondary smoke (ETS). This
number, considered high even by the EPA, was traced
in 1994 by the Congressional Research Service(CRS)
to an article by A. Judson Wells, "An
Estimate of Adult Mortality in the U.S. from
Passive Smoking, published in Environment
International in 1988.
The CRS stated that the editorial in the issue
containing the Wells article was directed at
Wells' article and said in summary: "The
editorial indicated that the study received mixed
reviews from reference -- two recommended
publication after revision and the third
recommended against publication on the grounds
that it was too speculative ... In the following
three years, there were a series of critiques and
rejoinders related to this paper."
The CRS report concludes with:
"In sum, this analysis suggests that
the Wells estimates are so high relative to
measures of the physical exposure that they seem
implausible. It also
suggests that the absence of controls or
the inability to control for other factors may be
a major problem in relying on epidemiological
estimates of the health effects of passive
smoking."
(Click here
for Congressional Research
Service's Report on 53,000)
FACT:
After
being accused by the London Telegraph of
withholding the study from publication because
its results were not what the World Health
Organization (WHO) wanted, WHO inaccurately
presented the results of its seven-year study
conducted in 12 research centers in seven
European cities under the leadership of
its cancer research branch, the International
Agency for Research on Cancer (IARC).
In reporting on the study, WHO
totally left out the following statement made in
the study about childhood exposure to ETS: "Our
results indicate no association between childhood
exposure to ETS and lung cancer risk."
(Click here
for abstract & url to full study: Click here: Report on the
Who Study Click here:
News on WHO Study)
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Report: Continued
FACT:
The conclusion
of a study -- begun by the American
Cancer Society and concluded by the University of
California at Los Angeles -- Environmental
Tobacco Smoke and Tobacco Related Mortality in a
Prospective Study of Californians, 1960-1998, by
James E. Enstrom and Geoffrey C. Kabat, published
in May 2003 stated: "The results do
not support a causal relation between
environmental tobacco smoke and tobacco related
mortality, although they do not rule out
a small effect. The association between exposure
to environmental tobacco smoke and coronary heart
disease and lung cancer may be considerably
weaker than generally believed."
(ENORMOUS STUDY UNMASKS THE
ANTISMOKING FRAUD: Environmental
tobacco smoke and tobacco related mortality in a
prospective study of Californians, 1960-98 - May
19th, 2003)
FACT:
The goal
of an epidemiological study is to determine
Relative Risk (RR). Relative Risk is
determined by first establishing a baseline, an
accounting of how common a disease or condition
is in the general population. This general rate
is given a Relative Risk of 1.0, no risk at all.
An increase in risk would result in a number
larger than 1.0. A decrease in risk would result
in a lower number and indicates a protective
effect.
When Robert Temple was
director of drug evaluation at the Food and Drug
Administration, he said: "My basic
rule is if the relative risk isn't at
least 3 or 4, forget it."
(http://www.forces.org/
evidence/download/fennel.pdf
Page 23)
The National Cancer Institute
has said: "Relative risks of less
than 2 are considered small and are usually
difficult to interpret. Such increases
may be due to chance, statistical bias, or the
effect of confounding factors that are sometimes
not evident."
(http://www.forces.org/
evidence/download/fennel.pdf
Page 34)
The International Agency for Research on Cancer (IARC)
said: "Relative risks of less than
2.0 may readily reflect some unperceived bias or
confounding factor."
(http://www.forces.org/
evidence/download/fennel.pdf
Page 34)
Dr. Kabat, IARC epidemiologist, said: "An
association is generally considered weak if the
odds ratio relative risk is under 3.0 and
particularly when it is under 2.0, as is the case
in the relationship of ETS and lung cancer."
FACT:
Meta-analysis
is commonly used in ETS studies (as in the EPA
report). Samuel Shapiro, Professor of
Epidemiology and Director of Slone Epidemiology
Unit, Boston University School of Medicine,
concluded his report "Is
Meta-Analysis a Valid Approach to the Evaluation
of Small Effects in Observational Studies?",
presented in a meeting on small risks, sponsored
by the Robert Kock Institute, and held at
Potsdam, Germany in October of 1995 by stating:
"What is likely to be the future of
meta-analysis?
"It appears that it is unlikely to go away,
and for that reason some epidemiologists have
argued that, rather than oppose it, a better
approach might be to contain its excesses.
" I disagree. I think there is
something profoundly amiss in the uncritical way
in which epidemiologists, and indeed the medical
profession as a whole, have allowed themselves to
be seduced by the numerological abracadabra of
meta-analysis. Perhaps the technique
will succumb to its own absurdity, but if not,
the next step in this surrealistic evolution will
be the meta-analysis of meta-analysis, in which
the meta-analyst will be totally divorced from
reality, and totally surrounded by numbers
without context.
"If anyone in this audience believes that
development is far off, he should familiarize
himself with the latest fashion of so-called
'evidence-based medicine' and 'systematic review'
now playing on the Internet. I would like to
conclude by quoting Alvan Feinstein
(Sterling Professor of Medicine and Epidemiology
at Yale). Feinstein and I have had our
differences from time to time, in this instance
we are in total agreement: 'The
meta-analysis of non-randomized observational
studies resembles the attempt of a quadriplegic
person to climb Mount Everest unaided.'"
(http://tobaccodocuments.org
/pm/2063633260-3266.html)
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Report: Continued
PRESS REACTION:
"There
is nothing more powerful than a lie whose time
has come," wrote Sidney Zion, New
York Daily News, July 23, 1998.
Zion went on to say: "Throughout history,
tyrants understood this, and so worked up the
populace. In this bloodiest of centuries, we've
seen it all from Hitler to McCarthyism. And now
we have the truth about the anti-smoke fascists.
Last week, a federal judge wiped out the
entire basis of all this business about the
danger of secondhand smoke, a lie that
has transformed our culture, from saloons to our
homes."
Zion, along with other writers, including John
Schwartz, the Washington Post, an editorial in
the Washington Times, Kathleen Parker, the
Chicago Tribune, Joseph Perkins, the Ventura
County Star, Charley Reese, the Orlando Sentinel,
and an editorial in Investor''s Business Daily
referred to the public being hoodwinked by the
EPA's 1993 report.
(Click links below for articles:
Zion, New
York Daily News
Schwartz,
Washington Post
Editorial,
Washington Times
Parker:
Chicago Tribune
Perkins:
Ventura County Star
Reese,
Orlando Sentinel
Editorial,
Investor's Business Daily)
The editorial "EPA: Environmental
Propaganda Agency,{ in Investor's
Business Daily stated: "The Environmental
Protection Agency jiggered the facts to push its
notion that passive smoke causes cancer. The
EPA's dishonesty was recently bare in court. But
it was too late for thousands of businesses and
towns that responded to the EPA's junk science by
passing anti-smoking measures."
The editorial went on to say: "Even
with this callous disregard for the truth, the
Environmental Propaganda Agency still found that
the relative risk associated with ETS and lung
cancer is 1.19 far below the accepted minimal
standard of 3 to 4. For comparison, the
relative risk of premature death associated with
drinking three cups of coffee per week is 1.3. Drinking
whole milk and lung cancer? 2.14.
(The 2.14
relative risk figure can be found on PubMed:
"Milk Drinking, Other Beverage Habits, and
Lung Cancer Risk," Department of Cancer
Control and Epidemiology, Roswell Park Memorial
Institute, Buffalo, NY)
The editorial asks: "How do you go
back and undo what the EPA did? You
can't. The myth is enshrined. The lie is
fact."
Or as Paul Joseph Goebbels, propaganda minister
for Nazi Germany, said, "If repeated often
enough, a lie will become the new truth."
FACT:
The Nazi
anti-tobacco movement was the world's strongest
anti-smoking campaign in the 1930s and early
1940s, said Robert N, Proctor, Department of
History, Pennsylvania State University.
His report, "The Anti-Tobacco Campaign of
the Nazis: A Little Known Aspect of Public Health
in Germany, 1933-1945," was funded by the
United States Holocaust Memorial Museum,
Washington, D.C.
(Click here to read report)
FACT:
The practices in
Nazi Germany strongly resemble the practices now.
THE MONEY TRAIL:
Questionable
statistics have not stopped anti-smokers groups,
the EPA, the pharmaceutical companies (who are
making a fortune from smoking cessation aids like
Nicorette) and research groups representing
various illnesses eager to cash in on the money
allocated from the tobacco settlement for studies
to help pay for their existence. They still cite
a study that was vacated by the district court
without mentioning the controversy surrounding
the study. And some, such as the American Cancer
Society, the American Heart Association and the
American Lung Association, have cited 53,000 in
their advertisements, first claiming the EPA as
its source, then attributing the number to
Stanley Glantz, Ph.D., a founder of Americans for
Nonsmokers' Rights (who has used the questionable
number often and was among the first to do so).
In recent years, antismoking forces have
continued to inflate the number of deaths
attributed to secondhand smoke without mentioning
that the numbers they cite were generated by
computers and don't reflect what's happening to
real people living in the real world. Ask
yourself: If the antismokers case is so
strong, why do they hang on to faulty studies and
statistics, citing them time and again and often
inflating the numbers?
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