Reduced incidence of admissions for myocardial infarction associated with public smoking ban: before and after study
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.38055.715683.55 (Published 22 April 2004) Cite this as: BMJ 2004;328:977
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It has been well documented the flaws in the Montana study
ascertaining the effect of a smoking ban on rate of myocardial infarction.
(Of note the results seem to be mirrored in other more substantive studies
as mentioned above and more recently in Scotland)
Linda N Phillips however scathingly critiques the authors for daring
to highlight the reduction seen in California with regards to myocardial
deaths.
Indeed there are differences (some great) in how the results were
obtained, which merit further discussion on how best to implement a
reduction in passive smoking.
It should be noted however that Linda N Phillips has misread the two
outcomes completely. The Montana study measures admission to hospital from
myocardial infarction. The Californian figures quote deaths from
myocardial infarction. Obviously there will be less deaths than admissions
as thankfully a large proportion of people survive a heart attack.
Furthermore Linda N Phillips uses the Californian numbers (17-18%
reduction in deaths) and compares to national average (13%) concluding
that the smoking ban in California in fact only had a 4-5% further
reduction in effect. She then goes on to therefore claim that the 40%
reduction seen is 'suspicious about the over-hyped Helena results'
Again however she is not comparing like with like (mortality versus
morbidity plus mortality)
She claims that the Montana study is not science. Indeed there are
flaws however she should perhaps realise that critising (in her view) bad
science with flawed logic serves no one.
Competing interests:
None declared
Competing interests: No competing interests
The Scientific Method states a change in the independent variable (in
this case, public smoke exposure) must cause a predictable and
reproducible change in the dependant variable (in this case AMI admissions
through the ER) The Helena report claimed this cause-effect was isolated
because Helena is a "closed system" where the effect could be measured
without interference from other variables such as bar and restaurant
patrons migrating to jurisdictions without bans. My initial impression was
that the residents were geographically isolated in a small town and had no
choice but to not be exposed to secondhand smoke during the ban. In other
words, that Helena was an "island" of civilization in a vast sea of
wilderness, and that during the ban, Helena residents had the choice of
either drinking and dining in smoke-free venues, or staying home. In the
report itself, it is claimed only two businesses violated the ban. But
what if this claim is invalid? The State of Montana’s website contains
minutes of an April 7, 2003 meeting of the State’s Committee on Business
and Labor where public testimony was given by citizens concerned with the
economic and health effects of smoking bans.
http://data.opi.state.mt.us/legbills/2003/minutes/030407BUS_Sm1.wpd
This may also be more easily viewed at my webpage in MS Word format at
http://kuneman.smokersclub.com/MTsenate040703.html
In attendance were representatives of various trade groups describing
the economic impact of Helena’s ban who gave testimony that:
1.) Restaurant business migrated to East Helena which had no ban. To quote
Laura Fix’s ( MT Restaurant Assoc.) testimony "This ordinance never
stopped people from smoking. They simply drove 1.3 miles outside of
town". and referring to her nightclub business "Their smokers left for a
competitor 1.3 miles down the road that sits just outside of the city
limits and their non-smoking friends went with them."
2.) Three of the major casinos ignored the ban. (and there are only 5
major casinos in Helena) To quote the owner of the Motherlode Casino "When
the patrons of privately owned city casinos and bars told their customers
last summer they couldn't smoke, those customers did not quit smoking.
They simply left town for the casino five minutes away outside the city
limits. Equally important, non-smoking customers did not fill those empty
seats". To quote Rich Miller of the MT Gaming Association… "Three of the
major of the major casinos in the city never complied with the smoking
ordinance".
When I first read the Helena article in the BMJ, I thought almost all
of Helena’s bar, casino and restaurant patrons were exposed to substantial
public smoking prior to the ban, exposed to almost no public smoking
during the ban, and then again exposed to substantial public smoking after
the ban was lifted. Yet, it is now clear any resident in the Helena area
had access to public smoke exposure during the ban, regardless of zip code
of residency. The authors claimed most jurisdictions do not experience an
abrupt decline in AMIs like Helena did, because the public’s exposure to
smoke declines slowly over time, as venues slowly adopt nonsmoking
policies of their own. With that, and migration over jurisdictional
boundaries for health care, an abrupt decline cannot be detected.
I have also researched the Montana Independent Review’s website.
Because of newspaper articles archived there, I no longer believe the ban
actually caused much decline in Helena’s patrons’ exposure to smoke.
Because, 1) 75% of Helena’s restaurants were already nonsmoking pre- ban
and hence, only 25% of Helena’s restaurant patrons were exposed to less
smoke during the ban than before the ban,
http://www.helenair.com/articles/2002/04/28/stories/headline/1a1.txt; 2)
some Helena restaurant patrons who preferred smoking, did migrate to East
Helena and were still exposed to smoke, 3)during the first two months of
the ban, the Health Department did not enforce it and violations were
common http://www.helenair.com/articles/2002/09/25/stories/helena/1a2.txt
Because complaints from business owners complying with the ban were
numerous, the Helena Police assigned one officer in September for 20
hours/week to do nothing except inspect businesses for compliance.
4) From the States’ committee minutes, at least 60% of Helena’s casino
patrons’ exposure was unaffected by the ban, although probably even more
than 60% patrons were unaffected because evidence was presented business
migrated to casinos either in violation, or located outside the area of
the ban.
Finally, Helena should have been a test case, where "smearing" did
occur because Helena’s patrons' exposure to smoke was already diminishing
before the ban due gradual phasing in of voluntary smoke-free policies in
restaurants, and that diminishment trend only continued downward during
the ban.
In conclusion, I have found yet another fundamental problem with the
Helena study…. that the independent variable (smoke exposure) did not
change substantially during the lifetime of the ban. If differences in
exposure due to the elimination of smoke in 25% of restaurants made smoke-
free by the ban, compliant bars, and the 40% of casinos which were
compliant, actually did cause the reported 40% decline in AMIs, we would
expect the California bans, which resulted in an almost 100% decline in
public smoke exposure in bars and restaurants between 1991 and 2001 to
have resulted in the elimination of all heart attacks within that state,
which according to the American Heart Association clearly did not happen
(1). Considering, in addition, that residential exposure was unaffected
by the ban, the reported 40% AMI decline in Helena is so huge, with
respect to the amount of smoke exposure which was actually eliminated,
that it is clearly implausible.
( 1) "Rate by State" fact sheet, as viewed at:
http://www.americanheart.org/downloadable/heart/1105390918119HDSStats200...,
California’s death rate from heart disease did not fall faster than
elsewhere in the USA between 1991 and 2001, and it was ranked 27th in
percent decline in age-adjusted cardiovascular disease deaths, 33rd in
percent decline in age-adjusted coronary heart disease deaths, and 34th in
percent decline in age-adjusted stroke deaths. California's restaurant ban
took effect in 1995, and the bar ban was added in 1998.
David W. Kuneman Assist. Dir. of the Midwest Region, The Smokers’
Club, INC. This is an uncompensated position; I receive no funding nor
economic incentive from any source for my work fighting smoking bans. I am
a current smoker
Competing interests:
Assist. Dir of the Midwest Region, The Smokers' Club, INC, Current Smoker
Competing interests: No competing interests
The preceding response by Stanton Glantz and Drs. Shepard and Sargent
is sadly inadequate in addressing either the Kuneman/McFadden study (1) or
the longstanding criticisms of the original Helena study. Their response
ignores the many substantive criticisms of their work,
the important questions raised about that work, and the impact of new and
more comprehensive research that challenges their public conclusions. It
does this while emphasizing the support of another small and similarly
flawed study.
It was gratifying though to see that the first sentence of the Helena
researchers’ response emphasized the tenuous nature of the claim for
statistical significance ascribed to their study. A Confidence Interval
extending from 1% to 79% is a crystalline indicator of the weak foundation
upon which any claims of significant correlation, much less causality,
would be based. The slightest jiggle of a single AMI could easily have
moved that lower boundary of 1% into the negative realm of non-
significance and it was good of the authors to remind us of this.
Unfortunately that bright beginning is immediately followed by a
logical and scientific fallacy. The claim that a community has to be
“small” in order to detect a natural experimental effect has no basis.
Indeed, the smaller the subject pool in a population with many
uncontrolled and potentially confounding variables at work, the smaller
the chances that any scientific finding will have any meaning at all.
The Kuneman/McFadden study was enormously more robust in this regard,
utilizing a patient and population base over 1,000 times as large as
Helena’s. Yet oddly it was criticized not only for being large but
because it was not “isolated” to a single hospital or two. Actually it was
indeed quite well “isolated” in the larger sense that the great bulk of
state populations stay within the borders of those states for most of
their working, recreational and medical needs -- perhaps even more so than
in a smaller geographically defined population such as Helena’s.
The Helena authors give a “for example” to illustrate that the K/M
study did not properly meet the “smallness” and “isolation” requirements
they emphasize, but the “example” they give seems somewhat confused since
it addresses neither requirement but instead discusses the phasing in of
smoking bans over time. They posit that this would result in a “smearing
out” of any 30 or 40% post-ban declines in heart attacks.
While it’s true that such effects might be somewhat attenuated over
time it should be pretty clear that there is simply no way that a 40%
*drop* in heart attacks could be “smeared into” a 6% increase, as found in
California, or a 32% increase over three years as observed in
Massachusetts. (2)
And the authors’ further note about Florida’s “snowbird” population
is simply irrelevant to the K/M study since any snowbird effect would have
clearly existed both before and after the introduction of Florida’s
smoking ban. Their concern about the retiree population in Florida also
seems poorly based since that population would have remained stable and
would likely require the same size or even larger affected hospitality
workforce.
Ignoring the new K/M data and the weakness implicit in the wide CI of
their own study, the Helena authors go on to assert once again that their
findings clearly indicate a real result due to the interplay of two, and
only two, factors: smokers quitting and reduced secondary smoke exposure.
Amazingly they repeat this assertion despite having failed to gather any
specific data on either factor and despite a failure to even analyze AMIs
in nonsmokers.
They do note that smoking histories for Helena/Pueblo were “spotty at
best,” but do not mention their strange neglect to specify what findings
they got or the oddity that despite early consultations with the Pueblo
authors those researchers failed to even gather such vitally important
data. Could it be that such data was not expected to support claims
promoting smoking bans?
The statement that the relative contribution of ETS effects on non-
smokers was simply “not important” is quite disingenuous given the
deliberate public portrayal of these studies as indicating a “threat” to
innocent nonsmokers and given the focus of Helena’s text. Relegating
consideration of the magnitude of such an effect to the realm of “non-
importance” is simply ridiculous when one views the use of these studies
in promoting smoking bans principally based on such a threat.
While the Helena authors have largely continued their policy of not
responding to questions and criticisms about their original work, they did
at least attempt to address “alternative explanations” by raising specific
points to be considered. Before addressing these myself I should note
that Dr. Michael Siegel has thoroughly addressed these from the viewpoint
of “random variation” in his excellent internet blog at
http://tobaccoanalysis.blogspot.com/
In their first point, the Helena authors note that there was a drop
in AMIs in Helena. They incredibly make no reference to the lack of such
a drop in either the K/M study or in Siegel’s extended analysis. The
authors are certainly familiar with the study, both from its presentation
here and through the fact that Dr. Siegel’s efforts were swiftly followed
by his expulsion from the tp-talk discussion list-serve for tobacco
control. (3)
In their second point the authors reassert that there was no drop in
AMIs in the area surrounding Helena, but somehow fail to mention the very
important counterpoint: there was an *increase* in surrounding AMIs.
Perhaps the increase was not statistically significant, but it was
certainly large enough to account for a real portion of the barely
significant drop found in Helena proper. Rather than ask for an
alternative explanation as to why there was no drop in surrounding areas,
the Helena authors should attempt to explain either why there was an
increase or why that increase was ignored by them.
The third point focuses on the “rebound” in AMIs after the Helena ban
was lifted. In reality, as the authors are fully aware, most of that
“rebound” actually occurred *not* after the ban was lifted, but actually
during the second half of the ban period itself. While the graph
indicating this was made available during the initial press release
parties in 2003 and was displayed on the Internet, the incriminating data
was eventually removed from both the net and the final BMJ publication.
However, while it has been removed from normal Internet access, there is a
little-known archival engine called the Wayback Machine that will allow
researchers to access it. (5) The original powerpoint graph shows that
during the first three warmer months of the ban when a lot of angry Helena
smokers and their friends probably partied out of town AMIs dropped from 6
down to 2 per month. In the second three colder months of the ban it
bounced back up to 5 per month. The bounce back did not occur *after* the
ban as claimed.
The final two notes by the Helena authors are also puzzling. The
claim that no alternative explanations have been offered is mystifying
given the Rapid Responses and other critiques that have been offered and
ignored over the past thousand days (6) (7).
And the final comment, “These large drops in AMI admissions… are
consistent with the large and immediate effects that secondhand smoke has
on blood platelets, vascular reactivity, and other determinants of
cardiovascular function.” has a puzzling set of references. None of those
references seem to clearly show “large and immediate effects” of the type
described from the levels of exposure that would commonly be encountered
in most businesses affected by smoking bans.
As noted earlier, the Helena authors’ attempt at responding to their
critics and buttressing their case is sadly inadequate. The Rapid
Response titled “Helena: 100 Days” enumerated 14 questions and criticisms
raised within just the first 10 days of the study’s publication. To offer
a response 900 days later that deliberately ignores those and other
concerns is reprehensible. To end that response once again with a
statement of “no competing interests” is even more so.
I would like to conclude by once again calling upon the BMJ to take
some form of corrective action, particularly since their publication of
this study has had such wide-ranging impact on the lives and livelihoods
of so many.
Michael J. McFadden
Author of “Dissecting Antismokers’ Brains”
http://pasan.TheTruthIsALie.com
(1) http://kuneman.smokersclub.com/hospitaladmissions.html
(2) http://tobaccoanalysis.blogspot.com/2005/11/new-study-casts-doubt
-on-claim-that.html
(3) http://tobaccoanalysis.blogspot.com/2005/12/rest-of-story-author-expelle...
(4) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#123038
(5) http://web.archive.org/web/20030724212153/http://no-smoke.org/HelenaPowe...
(6) http://www.foxnews.com/story/0,2933,100318,00.html
(7) http://cantiloper.tripod.com/canti11.html
Competing interests:
I am a member of several Free Choice organizations, and have written a book titled "Dissecting Antismokers' Brains." I have absolutely no financial connections with Big Tobacco, Big Hospitality, or any other player in this arena other than as a customer.
Competing interests: No competing interests
January 12, 2006
The Editor
British Medical Journal
Dear Sir,
The recent submission (24 December 2005) by Sargent, Shepard and
Glantz (1), suggests that the results of a study in Pueblo, Colorado (2)
confirmed the findings of their previous study in Helena, Montana,
discussed in this forum (3). Sargent et al. maintain that smoking bans --
in Helena in 2002, and in Pueblo in 2003 -- caused immediate declines (42%
and 27% respectively) in hospital admissions for acute myocardial
infarctions (AMI) in those communities.
We previously presented data showing that the Helena observations are
consistent with random variation because of the small number of
observations on which they are based (4). The recent submission from
Sargent et al. prompted us to update information for Lewis and Clark
County in Montana (which includes Helena) with important data for the year
of the ban (2002), and also to present similar data for Pueblo County in
Colorado.
The figures present annual mortality rates from 1979 to 2002 for
myocardial infarction (ICD-9 codes 410-410.9 for 1979-1998 and ICD-10
codes 121.0-121.9 for 1999-2001), among persons age 35+ years in the
respective counties. These rates, expressed as the number of deaths per
100,000 persons per year, are from the National Center for Health
Statistics Mortality Database, and are age standardized to the 2000 US
population.
Figure 1 shows that in some years AMI death rates in Helena were
quite low or high (designated by a * in the figure). The variability was
especially striking for two periods (yellow bars). More importantly, we
now have evidence that the AMI death rate of 66 in 2002, the year of the
ban (** in the figure), is slightly but insignificantly higher than that
in 2001 (63). We conclude that the smoking ban certainly had no effect on
the number of people in Lewis and Clark county who died from AMI in 2002.
Figure 2 shows a similar overall downward trend in mortality from AMI
over the 1979-2002 period in Pueblo county, and with similar variability,
especially in specific years (designated by a ! in the figure). Sargent
et al. are correct that Pueblo is a larger city than Helena (at risk
population in 2002: 75,600 in Pueblo versus 31,600 in Helena) with more
cases (AMI deaths in 2002: 59 in Pueblo versus 19 in Helena). But the
impact of this larger size on variability is modest. For example, if the
Pueblo ban had gone into effect in 2002 (!! in the figure) instead of
2003, smoke-free advocates might have claimed credit for a 28% drop in AMI
mortality (compared with 2001).
Sargent et al. believe that the Pueblo report confirms the findings
of the Helena study. The AMI mortality data from Pueblo confirms our
position that neither report involves anything more than random variation
Brad Rodu
Professor, Department of Medicine and Endowed Chair, Tobacco Harm
Reduction Research
Phone 01-502-561-7273
Fax 01-502-561-7280
Email: brad.rodu@louisville.edu
Philip Cole
Professor Emeritus, Department of Epidemiology
School of Public Health
University of Alabama at Birmingham
Birmingham, AL 35294
USA
Phone 01-205-934-6707
Fax 01-205-934-8665
Email: pcole@uab.edu
References
1. Sargent RP, Shepard RM, Glantz SA. Helena study independently
confirmed. 24 December 2005. bmj.com
2. Bartecchi C, et al. A city-wide smoking ordinance reduces the
incidence of acute myocardial infarction. American Heart Association
Annual Scientific Sessions, 2005. Dallas, TX.
3. Sargent RP, Shepard RM, Glantz SA. Reduced incidence of
admissions for myocardial infarction associated with public smoking ban:
before and after study. BMJ 2004; 328: 977-980.
4. Rodu B, Cole P. Additional information on acute myocardial
infarctions in Helena, Montana. 25 May 2004. bmj.com
Competing interests:
Research by the authors is supported by unrestricted grants from smokeless tobacco manufacturers to the author’s respective institutions. The manufacturers were unaware of this work, and thus had no scientific input or other influence with respect to its submission.
Competing interests: No competing interests
It seems premature to conclude that the observed 14% decline in heart
attack deaths in New York City was a change attributable to the smoking
ban, implemented late in 2003.
It appears that the only data upon which this claim is made is the
observation that the number of heart attack deaths in New York City in
2004 (3,680) was 13.9% lower than in 2003 (4,275).
Comparing these two numbers to estimate the effect of the New York
City smoking ban is, in my view, questionable science.
It seems to me that one could just as easily conclude that the
observed 9.3% decline in drug and alcohol-related deaths in New York City
between 2003 and 2004 was attributable to the smoking ban, or that the
observed 9.1% increase in hypertensive heart disease deaths was due to
this policy.
If one looks more fully at the overall trends in heart attack
mortality in New York City, it turns out that heart attack deaths in New
York City have been declining for several years.
In fact, between 2002 and 2003 (the smoking ban took effect late in
2003), there was a 6.3% decline in heart attack deaths in New York City.
So if heart attack deaths had simply followed the pre-existing annual
trend, it would have dropped by 6.3% between 2003 and 2004.
And, in fact, not only had heart attack deaths been declining in New
York City, but the rate of decline in heart attack deaths had accelerated
during the previous three year period. The rate of decline in heart attack
deaths was only 0.8% from 2000-2001, but rose to 4.5% from 2001-2002, and
to 6.3% between 2002 and 2003.
Based on the trend in the pre-existing observed decline in heart
attack deaths in New York City, the expected decline in heart disease
deaths from 2003 to 2004 was in fact 9.3%. Thus, the true decline
"attributable to the smoking ban" was in fact not 13.9% as claimed, but
only 4.6%.
It seems obvious that this does not, in fact, provide any evidence
for the plausibility of a 40% decline in heart attack admissions in Helena
attributable to the smoking ban.
In addition, while the claim in Helena was a 40% decline in the
incidence of heart attacks due to the smoking ban, the New York City data
relate to mortality. Many factors, in addition to changes in heart disease
incidence, affect heart disease mortality changes, not the least of which
is the treatment for heart disease, which has drastically improved in
recent years. It is therefore not valid to attribute changes in heart
attack deaths solely to changes in risk factors for heart disease.
My concern in responding here has nothing to do with the
justification for smoking bans, which I support based on the evidence for
the hazards of occupational secondhand smoke exposure. My motivation in
responding is that I am afraid that the credibility of tobacco control
scientists and practitioners may be threatened if scientific claims are
made that are not adequately justified. If true, that may well undermine
our ability to advocate effectively for the policies that are needed to
protect people from secondhand smoke.
Competing interests:
None declared
Competing interests: No competing interests
On January 5, 2006, the Associated Press reported that the number of
fatal heart attacks dropped 14 percent between 2003 and 2004 in New York
City (Fewer New Yorkers dying of heart attacks; less smoking cited By
David B. Carouso). This drop follows a smokefree law that went into
effect on July 24, 2003. This result represents an additional independent
confirmation of the conclusion that smokefree policies produce rapid and
substantial reductions in heart attacks.
One would expect a smaller change -- as was observed -- in New York
City than in isolated places like Helena or Pueblo because not all people
covered by the ordinance would be hospitalized in New York City and vice
versa. In addition, there were earlier ordinances in some surrounding
jurisdictions who would just work or live in New York City, which would
"smear out" the effect in time. In addition, the ordinance was only in
effect for half the year, which would also reduce the observed magnitude
of the effect.
Competing interests:
None declared
Competing interests: No competing interests
We are gratified that the results in our original paper [1], which
reported a 42% (95% CI 1% to 79%) statistically significant drop in
hospital admissions for acute myocardial infarctions (AMI) when Helena,
Montana enacted a smokefree policy was recently confirmed by an
independent group [2] that found a similar 27% (95% CI 15% to 37%) drop
when Pueblo, Colorado enacted a similar law. The Pueblo study has the
advantage of being a larger city, with more cases and so, yields a more
precise estimate of the effect size.
These two communities provide appropriate “natural laboratories” to
examine the impact of these policies of heart disease because they are
isolated and small enough that all people were hospitalized at the same
hospitals, thus eliminating the effects of between-hospital variation.
These conditions, which are necessary to be able to detect an effect, have
not been present in larger jurisdictions for several reasons. For
example, in California smokefree legislation was introduced predominately
at the local level over a period of many years, thus “smearing out” the
effect in time. (Nevertheless, the California Tobacco Control Program,
which emphasized creation of smokefree policies, was associated with a
substantial drop in mortality from heart disease [3].) Analysis of data
from a state like New York is complicated not only by the fact that the
laws were passed over a period of several years, but also by the fact that
people who might work in New York could live (and be hospitalized) in
other states, or vice versa. Florida also has a population of “snow
birds” who come and go with the seasons; in addition, many of these people
are retired and not affected by smokefree workplace legislation.
It is also important to emphasize that the observed drop in AMI
observed in Helena and Pueblo represents a combination of lower exposure
to secondhand smoke as well as the fact that smokefree policies lead some
smokers to cut down or quit [4]. Unfortunately, the collection of data
on smoking histories is spotty at best, it is not possible to assess how
much of the observed drop in AMI admissions is do to each of these two
effects. In terms of the net public health benefit of these laws, the
balance between these two effects is not important.
In thinking about possible alternative explanations for the findings
in our and the Pueblo study, it is important to consider all the
observations:
1. In both cities there was a substantial drop in AMI admissions when
the smokefree laws went into effect.
2. There was no such drop in AMI admissions from people from the
surrounding area (and, in the case of the Pueblo study, a nearby city) who
were not covered by the ordinance. These people went to the same
hospitals and were subject to the same environmental factors (air
pollution, weather, etc) as people living in Helena and Pueblo.
3. There was a rebound in AMI admissions in Helena when enforcement
of the law was suspended.
4. There was no change in the underlying pattern of AMI admissions
in the surrounding area when enforcement of the Helena ordinance was
suspended.
None of the individuals who have questioned either our or the Pueblo
study have provided a plausible alternative explanation for these facts.
These large drops in AMI admissions, while on first blush, were
surprising, are consistent with the large and immediate effects that
secondhand smoke has on blood platelets, vascular reactivity, and other
determinants of cardiovascular function [5-7] .
Richard Sargent, MD
Robert Shepard, MD
Stanton Glantz, PhD
References
1. Sargent, R.P., R.M. Shepard, and S.A. Glantz, Reduced incidence of
admissions for myocardial infarction associated with public smoking ban:
before and after study. Bmj, 2004. 328(7446): p. 977-80.
2. Bartecchi, C., et al. A city-wide smoking ordinance reduces the
incidence of acute myocardial infarction. in American Heart Association
Annual Scientific Sessions. 2005. Dallas, TX.
3. Fichtenberg, C.M. and S.A. Glantz, Association of the California
Tobacco Control Program with declines in cigarette consumption and
mortality from heart disease. N Engl J Med, 2000. 343(24): p. 1772-7.
4. Fichtenberg, C.M. and S.A. Glantz, Effect of smoke-free workplaces
on smoking behaviour: systematic review. Bmj, 2002. 325(7357): p. 188.
5. Pechacek, T.F. and S. Babb, How acute and reversible are the
cardiovascular risks of secondhand smoke? Bmj, 2004. 328(7446): p. 980-3.
6. Barnoya, J. and S.A. Glantz, Cardiovascular effects of secondhand
smoke: nearly as large as smoking. Circulation, 2005. 111(20): p. 2684-98.
7. Raupauch, T., et al., Secondhand smoke as an acute threat for the
cardiovascular system: A change in paradigm. Eur Heart J, 2005.
doi:10.1093/eurheartj/ehi601 (epub ahead of print)(i).
Competing interests:
None declared
Competing interests: No competing interests
Well, to be truthful, it's really only Helena plus 976 days. The
original press release circus started on April 1st, 2003 although the
formal BMJ publication did not take place until a year later.
Still, it *has* been many hundreds of days since criticisms,
concerns, and questions about Helena appeared here with no more than a
single, and sadly Ad Hominem flavored, response. (1) Meanwhile
antismoking lobbyists have continued to push for smoking bans using the
base of Helena and similar studies to frighten people and legislators
about the "deadly threat" of wisps of secondary smoke with nary a mention
of such criticisms and questions.
Particularly disturbing is the recent study done in Pueblo, Colorado.
Despite initial consultations with the Helena authors the Pueblo
researchers not only neglected to incorporate data on smoking statuses but
did not even gather such data! And, just as with Helena, the lack of such
supporting data did not stop the researchers from making public statements
such as this one by Dr. Mori Krantz: "This study further validates the
argument that limiting exposure to deadly tobacco smoke can save lives."
(2)(3)
Why am I choosing to post this response now rather than wait the full
1,000 days? I am doing so because a related event of some significance
has occurred. Three days ago Dave Kuneman and I published an expanded
Helena-type study at SmokersClubInc.com and Dr. Michael Siegel has
reviewed and expanded upon it in his web blog. (4)(5)
In brief, when a database of figures literally 1,000 times larger
than Helena was considered and analyzed, the theoretical 30 to 50% post-
ban drop in heart attacks simply disappeared. It was not reduced… it was
eliminated altogether. The figures and the work involved are not hidden
from public view and examination but are fully open through public
government records and the straightforward and simple analysis of those
records. Can the same be said of the Helena data?
The data for such states as New York was not yet available at the
time of the Helena study, but the data for California has been readily
accessible to researchers for years. It is hard to imagine that the
Helena researchers never examined those figures and were simply unaware
that there was a large and significant source of data that directly
contradicted their conclusions. For them to have neglected even
mentioning such data in their study presentation seems unfortunate to say
the least. While California's figures may not be as "pure" as Helena's due
to the more gradual phase in of the smoking bans there, it was certainly
quite clear that there was no massive drop in heart attacks resulting from
those bans. Not only did the much touted study in Helena fail to directly
show anything at all about secondary smoke, it promoted conclusions based
upon a very small sample while ignoring the easily available public data
based upon a far larger sample. Tobacco companies have long been accused of promoting and funding
selective research. Is the Antismoking Industry equally at fault?
The Helena researchers were challenged in earlier responses to
acknowledge the conflict of interest that stemmed from the orientation of
the funding sources for much of their work. Researchers in this field
have generally refused to acknowledge such conflict despite the fact that
their livelihoods often depend upon consistently producing research
pleasing to organizations that have an openly declared agenda of promoting
such things as smoking bans. It is unlikely that the Robert Wood Johnson
Foundation or the American Legacy Foundation would continue regular
funding of any researcher who consistently designed and conducted research
showing the relative harmlessness of secondary smoke in well-ventilated
situations.
Stanton Glantz and others have actively urged universities to eschew
any research funded by "Big Tobacco." (6) The Enstrom/Kabat study brought
forth a wave of pressure against publishing such research. (7) Perhaps it
is time for Antismoking funding to be considered as being in the same boat
as Big Tobacco funding.
Much can be determined about a study's outcome at the stage of basic
study design. More can be determined by the proper selection of data
gathered and the tests and methods used to analyze it. And finally still
more can be ordained by the researchers' words that surround those basic
findings. In the case of Helena we saw references to secondhand smoke a
full dozen times in the text of the study, despite the fact that there
were no measurements of smoke levels, no measurements of exposure to
smoke, and no reported analysis of heart attacks among nonsmokers. But
the words and orientation of the study clearly set the stage for the
cascade of public statements indicating that Helena proved the need to
"protect" nonsmokers from wisps of smoke.
It's closing in on 1,000 days since the original press conferences
indicting secondary smoke and calling for smoking bans. That indictment
was deeply and fatally flawed but the world has never been properly made
aware of that fact. We now see that even the more proper claim that could
have been made about Helena, that smoking bans produce an immediate and
generalized drop in heart attacks, may be just as deeply and fatally
flawed.
The Kuneman/McFadden analysis of multi-state data, expanded and
affirmed by Dr. Siegel, indicates clearly that smoking bans do not produce
the predicted massive drops in heart attack rates that so many smoking
bans have recently been based upon and most certainly indicates that
"protecting nonsmokers from secondhand smoke" does not produce such an
effect.
This time the world should be invited to see the truth and the
British Medical Journal should be in the forefront of ensuring that such
an invitation is heard.
Michael J. McFadden
Author of "Dissecting Antismokers' Brains"
http://pasan.TheTruthIsALie.com
References:
(1) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#61207
(2)
http://www.helenair.com/articles/2005/11/15/helena/a02111505_01.txt
(3) http://biz.yahoo.com/prnews/051114/lam013.html?.v=30
(4) http://kuneman.smokersclub.com/
(5) http://tobaccoanalysis.blogspot.com/2005/11/new-study-casts-doubt
-on-claim-that.html
(6) http://www.shns.com/shns/g_index2.cfm?action=detail&pk=LUNDSTROM-
02-17-05
(7) http://bmj.bmjjournals.com/cgi/eletters/326/7398/1057
Competing interests:
I am a member of several Free Choice organizations, and have written a book titled "Dissecting Antismokers' Brains." I have absolutely no financial connections with Big Tobacco, Big Hospitality, or any other player in this arena other than as a customer.
Competing interests: No competing interests
On April 5th 2004, 100 days ago, the online British Medical Journal
published "Reduced incidence of admissions for myocardial infarction
associated with public smoking ban: before and after study," a study that,
according to media releases around the world, conclusively demonstrated
the deadly effects of secondary smoke and the immense and immediate
medical benefits that had been demonstrated once people were protected
from "the deadly poison." (1)
The release almost immediately generated a storm of criticism within
these virtual pages as Rapid Responses containing over a dozen substantial
questions and criticisms were generated within ten days.(2)
Throughout the entirety of that 100 day period, only one response has
been made by the authors of the study. That response was two months in
coming and ignored over 90% of the questions and criticisms that had been
raised while taking an Ad Hominem slap at the most recent pair of
questioners by accusing them of "following a well-established tobacco
industry strategy..." (3)
Perhaps the most serious of all the charges made was the one that
charged deliberate misrepresentation of results to the media, and the one
that criticized the lack of honesty in the declarations of competing
interests.
In the first instance the charge of misrepresentation was clearly not
directed at the Journal, but was instead aimed at the conscious
presentation of the study by the authors and other supposedly responsible
medical and tobacco control authorities as having directly examined and
strongly condemned the cardiovascular effects of secondary smoke. As
pointed out quietly by the authors themselves in the study, no attempt was
made to even estimate such an effect.
In the second instance however the charges were laid at the feet of
both the authors who neglected, even after criticism, to openly admit
their potential conflicts of economic interest; and at the feet of the
Journal which seems to be ignoring the demand that such conflicts be
openly exposed for proper consideration by readers and future researchers.
The 14 points below represent only those raised and ignored in the
first ten days; there are others that cry equally loudly for response as
well. The British Medical Journal has demonstrated its courage in
publishing the Helena study and opening its details to direct public
examination rather than leaving them in a limbo of interpretation only
through press release. It has also shown courage and responsibility in
opening its pages to those around the world who have criticized not only
this study, but others that were scientifically weak although serving
sacrosanct political and medical goals. It needs to prove itself equally
courageous in demanding that the Helena study authors responsibly respond
to their critics and questioners in the true spirit of peer review and
public accountability, and that they do so with a full and open admission
and listing of their competing interests.
Sincerely,
Michael J. McFadden
Author of "Dissecting Antismokers' Brains"
Footnotes:
(1) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#55832
(2)
1)why the enormous difference in ratio of reviewed and included admissions
for primary < 274/283> and secondary <30/71> diagnoses;
2)why the limitation of previous six-month periods to just the most recent
four <1998 - 2003>;
3)how three patients experienced multiple admissions but only had a total
of five admissions among the three;
4)why similar changes have not been noted among the many prison
populations that have experienced similar smoking bans;
5)why funding from a number of organizations who have declared openly
their belief in pushing for smoking bans is not considered a conflicting
interest;
6)why the presentation and the bulk of discussion in the study was
deliberately oriented toward secondary smoke while the formal study itself
never specifically examined secondary smoke, exposures to it, or the
statistical effects of the ban on nonsmokers;
7)why the initial results boasted a 60% reduction while the final showed
only 40%;
8)why the finding of a 40% immediate reduction in Helena was claimed to be
supported by studies showing only a 5% reduction in California over a
period of years;
9)why the findings of increased hospital admissions immediately outside
the Helena area were not factored into the reduction of admissions within
Helena but were instead simply dismissed as non-significant;
10)what impact transient traffic or recall bias had upon the study;
11)what impact would have been made by using different criteria for
determining relevant admissions;
12)what impact would have been made by using different criteria for those
assigned to the different groups (e.g. by including/excluding those who
were retired and unaffected stay-at-homes or those who had simply had a
single dinner or lunch in Helena at the time of their event);
13)what difference in conclusion might have been forthcoming if the
authors had examined three month rather than six month periods, given the
clear disparity observed during the first three months of the smoking ban
as opposed to the final three months;
14)what impact on the final numbers could have been attributed to the
increased time at least some, and perhaps many, smokers spent outside the
ban area during the course of the ban, particularly during that telling
first three month period of good weather and possible resentment and what
effort, if any, was made to examine such impact.
(3) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#61207
Competing interests:
I am a smoker and a member of several Free Choice organizations, and have written a book titled "Dissecting Antismokers' Brains." I have absolutely no financial connections with Big Tobacco, Big Hospitality, or any other player in this arena other than as a customer.
Competing interests: No competing interests
Re: Re: These dramatic findings warrant a more objective view of the study's limitations
The view EMI visits would be reduced by implementing smoking bans and
higher taxation as a cure, of what we view as an addiction, defies not
only a moral obligation in dealing with addiction but our observations of
time line as well, particularly over the past 50 years. If the numbers of
primary smoking are flawed, so too are the believed effects of second hand
smoke which largely rely upon those primary smoking risk numbers. That
would be true of course in the absence of claim “Environmental tobacco
smoke [ETS] carries a separate risk which is somehow found to be much more
decisive. A plateau not yet obtained by the research however one which
grows ever closer; as a result of determination, in the absence of
unbiased perspectives.
Population risk [PR]
Smoking related disease 20% of all annual mortality [AM] or .2. If
true in a population of 320 million 2.25 million deaths occur annually.
This number due to population growth represents Less than 1% of total
population. And 450.000 smoking related mortalities [PR] occur as a
subset.
2007
320 million population 2.25 million mortalities
PR x AM = .45 million smoking related mortalities
1960
100 million population 1 million mortalities
PR x AM = .2 million smoking related mortalities.
[Less than half of what occur today with less than 1/3 the
population]
If population growth were comparable we would of course expect to see .75
million mortalities and we can check again on that basis.
Revised for population growth
100 million population .75 million mortalities
PR x AM = .15 million smoking related mortalities
This number would fall in line with all population numbers assumed as
being equal.
Triple the population triple the mortalities which makes perfect sense;
Differences in both PR and AM have been eliminated, yet the large
disparity in what we should expect, and what we actually see remains.
The problem? If we consider the reality that the actual number of
smokers has not changed, in all three population groups, at close to 55
million throughout, we see clearly the population risk has tripled over
the past 47 years while smokers in the percentage of population view
declined by a similar number, while remaining essentially stable in actual
numbers. How do we explain the increase in respect to a stable cause? Or
the underlying perspective being promoted by such efforts as the Helena
research which seems to indicate; on the whole, a decrease in total
population smoking rates equates a complimentary inversely associated
increase in smoking related mortalities.
Now explain how smoking bans and taxation of an addiction will
improve the situation. The cause assumed as smoking, as a constant for 47
years, should exhibit a constant effect in related disease and mortality
numbers.
By the evidence above we have to conclude as a population risk
smoking poses zero risk.
The alternative being of course; the numbers aggressively touted by
every medical, scientific institution and medical charity on the planet
are deeply flawed.
Competing interests:
None declared
Competing interests: No competing interests