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.
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.
Rapid Response:
Independently Confirmed?
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