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PREFACE
May 4, 2005 - The public's growing
awareness that the studies on passive smoke are statistical trash
along with the knowledge that the health authorities are
representing such trash as scientific evidence is a positive
development. Many readers, however, have asked us for an
exhaustive list of the reasons why these studies are trash.
The health authorities often state or
imply that "smoking is
indefensible." That statement is absurd. Smoking is
perfectly defensible because none of the alarms swirling about
passive smoke have any scientific foundation, while those regarding
active smoking are huge exaggerations as well. Both are
entirely based on incalculable factors. Let's set aside active
smoking for now and consider the "dangers" of passive smoke that are
the bases of smoking bans enacted to "protect the health of
nonsmokers" - a protection that has no actual basis since passive
smoke has never been demonstrated statistically or scientifically as
dangerous, or risky. Thus what is indefensible is the false representation of evidence
by authority. Such false representation is easily demonstrable.
THE LONG LIST OF METHODOLOGICAL ERRORS IN THE
JUNK SCIENCE OF PASSIVE SMOKE
- The claims of exposure
are not authentic. Exposure is not measured. The studies actually
measure nothing, but rely on the vague and grossly imprecise recall
of queried subjects who attempt to evoke in a few minutes their
individual lifetime memories of passive smoking exposure.
- Errors in individual
exposure recollection, most likely large, are unknown ,and are unknowable.
Digitized numerical claims of exposure are, therefore, incongruous
and impermissible. Their numerical representation gives an
impression of reliability and precision that is demonstrably false
and misleading.
- A recall bias has been
demonstrated to be larger in subjects, who are more likely to
amplify their recall of passive smoking exposure as a
justification for their disease, with lung cancer or cardio
vascular disease.
- A misclassification
bias has been demonstrated to be larger in subjects with lung cancer or
cardio vascular disease because they are more likely than healthy subjects to classify themselves as
nonsmokers.
- A mismatch error of
cases and controls is inevitable because the groups compared are not
homogeneous and differ in many characteristics other than recall of
passive smoking exposure.
- Confounding errors by
definition are likely to be more prevalent among lung cancer and
cardio vascular disease
cases. Confounders are all other known and unknown potential causes
of lung cancer and cardio vascular disease that interfere with the specific attribution
of risk to passive smoking.
- Probable errors of disease
diagnosis are seldom addressed by passive smoking studies.
- Publication errors have
been found to favor the publication of studies that claim
associations of increased risk.
- Statistical errors of
sampling and statistical significance are grossly inconsistent among
passive smoking studies owing to the feeble differentials of exposure recall
and the small number of subjects in each study. A majority of
studies have not reached statistical significance. In any event,
significant or not, the statistical indices of all passive smoking studies are
illusory because they are derived from the grossly illusory and
misleading numerical renderings of vague individual exposure
recalls.
- Results from different
studies have not been consistent and reproducible.
- Epidemiologic criteria
of causal inference (the Hill criteria) are not met by passive
smoking studies.
- Attempts to summarize the results of different studies
by meta-analysis statistical techniques are illegitimate.
Results are
obtained by pooling heterogeneous and selected studies, giving
arbitrary preferential weights to certain studies, which, in any
case, are
handicapped by the sources of error listed above.
What must an epidemiologic
study warrant?
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A study must
warrant that its numerical representations of individual lifetime
ETS exposure recalls are true measures of actual exposures.
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A study must
warrant that an exposure recall bias affects cases and control
groups, and exposed and non-exposed groups at the same rate.
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A study must
warrant that subject selection and misclassification biases affect
cases and control groups, and exposed and non-exposed groups at the
same rate.
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A study must
warrant that known causal confounders affect cases and control
groups, and exposed and non-exposed groups at the same rate.
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A study must
warrant the accuracy of pathological and diagnostic records.
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The results from
different studies addressing the same subject must be consistently
reproducible.
In any study, the statistical margin of error of reported risks
should reach no less than the 95% level of significance.
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If the above
criteria are met, the results of a study should also be consistent
with Hill’s criteria of causality. (See below)
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Meta-analysis
summations shall not be credible unless performed on the basis of
all available studies. Such studies also must be of homogeneous
design and conduct, and must have met the above criteria of
validity.
Given
that the above is universally and medically accepted as
epidemiological practice:
- It is incontrovertible that
no
extant study can warrant that the numerical representation of
individual lifetime ETS exposure recalls is a reliable measure of
actual exposures.
- It is incontrovertible that
no
extant study can warrant that ETS exposure recall bias affects
cases and control groups, and exposed and non-exposed groups at
the same rate.
- It is incontrovertible that
no
extant study can warrant that subject selection and
misclassification biases (and other biases) affect cases and
control groups, and exposed and non-exposed groups at the same rate.
- It is incontrovertible that
no
extant study can warrant that known causal confounders affect
cases and control groups, and exposed and non-exposed groups at
the same rate.
- It is incontrovertible that
no
extant study has warranted the accuracy of pathological and diagnostic records.
- It is incontrovertible that results
from different studies addressing the same subject have been
grossly inconsistent and not reliably reproducible.
- It is incontrovertible that only
for a random minority of studies has the numerical margin of
error of reported risks been at or below the 95% confidence
level of statistical
significance.
- It is incontrovertible that
no
study of ETS has met Hill’s criteria of causality.
- It is incontrovertible that
no
meta-analysis summation of ETS studies has been performed on the
basis of all available studies, of studies that are of
homogeneous design and conduct, and of studies that have met the
above criteria of validity.
Hill's criteria
1) Strength of an association is a clue to causation,
although a strong association is neither necessary nor sufficient to
affirm causality, and a weak one is neither necessary nor sufficient
to deny causality.
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In the case of passive smoke it is clear that
the associations are extremely weak, as confirmed by the
authoritative opinions below:
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National
Cancer Institute
- “In epidemiologic research, relative risks of less than 2 are
considered small and usually difficult to interpret. Such
increases may be due to chance, statistical bias or effects of
confounding factors that are sometimes not evident.” –
National Cancer Institute, “Abortion and possible risk for
breast cancer: analysis and inconsistencies,” October 26,
1994.
Sir
Richard Doll
- " ... when relative risk lies between 1 and 2 ...
problems of interpretation may become acute, and it may be
extremely difficult to disentangle the various contributions
of biased information, confounding of two or more factors, and
cause and effect."
“The Causes of Cancer," by Richard Doll, F.R.S. and
Richard Peto. Oxford-New
York, Oxford University Press, 1981, p. 1219.
WHO/IARC -
“Relative risks of
less than 2.0 may readily reflect some unperceived bias or
confounding factor, those over 5.0 are unlikely to do so.”
- Breslow and Day, 1980, Statistical methods in cancer
research, Vol. 1, The analysis of case control studies.
Published by the World Health Organization, International
Agency for Research on Cancer, Sci. Pub. No. 32, Lyon, p. 36
FDA
- “Relative risks of 2 have a history of unreliability” -
Robert
Temple, M.D. Food and Drug Administration Journal of the
American Medical Association (JAMA), Letters, September 8,
1999
FDA
- "My basic rule is if the relative risk isn't at least 3
or 4, forget it." -
Robert Temple, director of drug evaluation at the Food and
Drug Administration.
Average
cancer risk elevation for exposure to passive smoke: about 20%
(relative risk=1.2)
Average
cardiovascular disease risk elevation for exposure to passive
smoke: about 30% (relative risk=1.3)
Quality
of methodology and data gathering on passive smoke in all
studies: trash |
2) Consistency of results from different studies is an
obvious attribute of true causal relationships.
- Epidemiologic studies of
passive smoke are grossly inconsistent, and
epidemiologic associations that are inconsistent are quite unlikely
to be true.
3) Specificity requires that a cause leads to
a single
effect, which is seldom the case in multi-factorial epidemiology.
- Passive smoke has been claimed to cause
many different effects.
4) Temporality. That effects must occur after
the cause has a chance to act is a self-evident and trivial
criterion of causality.
5) Dose-effect relationship is a useful criterion of
causation, but does not resolve the matter.
- Such an effect is the exception in
passive smoke studies.
6) Plausibility. Whether an association is
biologically plausible or not remains a matter of individual
speculation and is far from being objective or conclusive.
7) Coherence. Agreement with other information
may be a corollary attribute but not evidence of causation.
8) Experimental evidence. Experimental evidence
in humans would indeed constitute proof of causation, but it is
unavailable in the case of passive smoke.
9) Analogy is open
to imagination and remains an invalid
criterion of causation.
CASE
CLOSED
The above
are not opinions: these rules are the basis of science,
epidemiology and statistics, rendering the supposed importance of
the authority releasing the study - or the entity financing it
- irrelevant. These fundamental
rules are systematically violated to "square the
balance", justifying prohibition, fulfilling an ugly thirst for
power, as well as enacting the pharmaceutical agenda.
Even setting aside the violations we have demonstrated, the studies
still demonstrate nothing, but they are nevertheless touted by the health
authorities as if they meant something.
This
is the reason why anti-tobacco operatives at all levels continue to
refuse public
debates on the validity of their junk science and the truthfulness
of their statements.
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