A study of trends in annual heart attack admissions through the emergency room by state refutes the conclusions of the Helena, Pueblo, Piedmont, and Bowling Green studies which concluded that smoking bans cause immediate, drastic declines in heart attacks. The study was conducted by Michael J. McFadden and David W. Kuneman. A preliminary version of the study appeared online in November 2005, while the final version, discussed on the American Council on Science and Health (ACSH) FactsAndFears blog, confirmed and strengthened the original findings.
McFadden and Kuneman overcame the two chief limitations of the existing research: (1) the small number of heart attacks in the cities studied, which resulted in tremendous baseline year-to-year variability in heart attack rates; and (2) the bias inherent in relying only upon the experiences of only a few small cities in making generalizations intended to apply to larger populations. They accomplished this by considering the following premise: if smoking bans cause an immediate decrease in heart attack admissions on the order of a 25% to 50% decline, then if one examines trends in heart attack admissions on an entire state level, then one should certainly observe a notable decline immediately following the implementation of statewide smoking bans.
Using data on emergency room admissions for acute myocardial infarction (heart attacks) from the Agency for Healthcare Research and Quality's HCUP database, McFadden and Kuneman examined trends in four states that implemented statewide bar and/or restaurant smoking bans - California, Oregon, Florida, and New York - and five states with neither a statewide smoking ban nor widespread local smoking bans - Arizona, New Jersey, South Carolina, and Iowa. They also examined trends in heart attack admissions for the United States as a whole.
California's restaurant smoking ban took effect in January 1995. In that year, heart attack admissions in California increased by 0.6%. In 1996, admissions increased by 2.9%. The corresponding changes for the United States were an increase of 3.2% in 1995 and 3.9% in 1996. California's bar smoking ban took effect in January 1998. In that year, heart attack admissions in California increased by 6.0%, compared to an increase of 6.2% in the nation as a whole. In 1999, admissions increased by 3.7% in California and decreased by 1.3% in the U.S.
Florida banned smoking in all restaurants in July 2003. Its heart attack admissions decreased by only 0.7% that year, and by only 2.0% the following year. In comparison, admissions in the U.S. decreased by 2.8% in 2003 and 8.2% in 2004.
Trends in heart attack admissions following the Oregon and New York smoking bans were also not found to be substantially different from national trends, or from trends in the comparison states without smoking bans.
The Rest of the Story
While this study certainly does not prove that smoking bans have no effect on heart attack admissions, what it does is demonstrate that when one examines population-based data for an entire state, one does not find any evidence of a dramatic decline in heart attacks immediately following the implementation of smoking bans. This casts serious doubt on the conclusion of the Helena, Pueblo, Piedmont, and Bowling Green studies. If smoking bans truly cause an immediate and dramatic decline in heart attacks, on the order of a 25% to 50% reduction, then why do we not observe any evident decline in heart attacks when entire states implement smoking bans.
The chief limitation of the study is that some localities within these states had already enacted smoking bans, so one would not expect to see as dramatic an effect on a statewide level. However, the proportion of residents in these states covered by local smoking bans was not particularly high. For example, the authors cite data that only 14% of Californians were covered by a smoke-free restaurant law in 1993. This increased to 100% in 1995. Yet the number of heart attack admissions increased from 1993 to 1995 (and increased further in 1996). The corresponding changes in the U.S. data were similar. So it does not seem that the existence of some local smoking bans is enough to invalidate the study conclusion.
I have already discussed in detail the reasons why I believe the conclusions of the Helena et al. studies are unjustified. Briefly, the chief flaw of these studies is that they are unable to rule out the very likely possibility that the observed changes in heart disease admissions in these cities during the study period are due primarily to random variation, rather than to the smoking bans. There is tremendous natural (random) variation in the heart disease admission rates in these cities because of the small population sizes. Because we are dealing with such small numbers of admissions, the percentage change in admissions from one year to the next is very high, even without any smoking ban.
While these papers make some attempt to account for these baseline trends, I do not believe that they go back far enough in time to do so adequately.
Because McFadden and Kuneman have examined heart attack trends among large populations, the number of heart attacks is much higher, and therefore the degree of underlying variability in the annual number of heart attacks is much lower. It is therefore easier to identify any major changes in the underlying trends.
I think it is high time that my fellow tobacco control researchers and practitioners recognize that the Helena et al. studies are examples of shoddy science that apparently now passes as acceptable in tobacco control research. While I support workplace smoking bans, I do not believe that we should be using shoddy science to promote them.
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Friday, July 13, 2007
Friday, June 29, 2007
Article in Nature Highlights Shoddy Science Behind Helena et al. Conclusions and 30 Minute Claims of Anti-Smoking Groups
An article by Dr. Kris Novak in this week's issue of Nature highlights my questioning of the validity of the conclusion of the Helena, Pueblo, Piedmont, and Bowling Green studies that smoking bans in those towns resulted in immediate, dramatic reductions in heart attacks. The article also highlights my questioning of the claim being made by many anti-smoking groups that 30 minutes of secondhand smoke causes clogged arteries and heart attacks among otherwise healthy nonsmokers.
According to the article:
"In principle, smoking bans provide a unique opportunity to study populations before and after reductions in second-hand smoke exposure. But if research into the incidence of heart attacks is any guide, the results of such studies are often far from clear and can cause more controversy. Glantz reported in 2004 that during a six-month smoking ban in Helena, Montana, the number of heart attacks dropped by 40% compared with the same months in other years. The study, cited in the surgeon general's report, was criticized for the small number of cases studied and the large month-to-month variations in incidence of heart attacks. Since the report, several studies have reported a drop in hospital admissions for heart attacks after smoking bans in the Piedmont region of Italy (11% drop), and in small cities in Colorado (27%) and Ohio (39%)."
"But not all epidemiologists are impressed. 'It's quite common to see major year-to-year changes in heart attacks, sometimes as much as a 50% increase or decrease,' says Michael Siegel, an epidemiologist at Boston University School of Public Health. Attributing such changes to a ban is impossible, he says. Worse, none of the studies recorded whether the changes occurred in non-smokers or in smokers, yet the effects of the ban are frequently attributed to reductions in second-hand smoke exposure. The lead author of the Ohio study agreed that a prospective study that collected data on groups of non-smokers and smokers in advance of a ban — and then followed them up for a few years after — would be ideal, but this would take longer and be costly." ...
Certainly, public-health officials seem convinced. Pechacek says that the general consensus in tobacco researchers is that the drop in heart attacks occurs mainly in non-smokers. Smokefree England suggests that just 30 minutes of breathing in second-hand smoke can raise your risk of having a heart attack. But can you really become ill just by sitting in a bar next to a smoker? 'Saying that just a little exposure is killing people is going overboard,' says Siegel, who worries that when researchers exaggerate their findings, they lose credibility with the public. 'I agree that second-hand smoke is a tremendous health hazard, but no one is going to have a heart attack from 30 minutes of exposure.'"
"Siegel thinks that banning smoking in outdoor places is going too far and risks losing support for smoking bans overall. Smoking has been banned on 25 California beaches, and this week the Beverly Hills City Council approved a ban in nearly all outdoor dining areas. 'We should focus efforts on the remaining areas in which workers are not protected,' he says. 'My biggest concern is for the waiters and bartenders who spend 40 hours each week in very smoky environments.' He's also worried about the health of smoking research itself, which he sees being compromised by methodological flaws and over-interpretation of results. And although prospective studies would be costly, Siegel argues that funding for a large prospective study of the effects of smoking bans on non-smokers is warranted. 'Although I wholeheartedly support smoking bans, I still believe that we must use solid science to advocate for such bans and that a noble end — improving public health — does not justify the compromise of our scientific principles.'"
The Rest of the Story
I don't have much to add to what Dr. Novak wrote. I'm just glad that the misrepresentation of the science by anti-smoking groups and the deterioration of the quality of the scientific conclusions being made in the movement are being highlighted in a scientific journal with the high quality and fine reputation of a journal like Nature. I hope this will force anti-smoking groups to re-examine their decisions to disseminate misleading, if not inaccurate, health information and encourage the tobacco control movement to take stock of the deterioration of its scientific integrity and take steps to restore it.
Unfortunately, I don't think either of these will happen, because frankly, I really don't think that the movement, as an entity, actually cares. As long as its political aims are being met, I don't think that scientific integrity really enters the picture.
According to the article:
"In principle, smoking bans provide a unique opportunity to study populations before and after reductions in second-hand smoke exposure. But if research into the incidence of heart attacks is any guide, the results of such studies are often far from clear and can cause more controversy. Glantz reported in 2004 that during a six-month smoking ban in Helena, Montana, the number of heart attacks dropped by 40% compared with the same months in other years. The study, cited in the surgeon general's report, was criticized for the small number of cases studied and the large month-to-month variations in incidence of heart attacks. Since the report, several studies have reported a drop in hospital admissions for heart attacks after smoking bans in the Piedmont region of Italy (11% drop), and in small cities in Colorado (27%) and Ohio (39%)."
"But not all epidemiologists are impressed. 'It's quite common to see major year-to-year changes in heart attacks, sometimes as much as a 50% increase or decrease,' says Michael Siegel, an epidemiologist at Boston University School of Public Health. Attributing such changes to a ban is impossible, he says. Worse, none of the studies recorded whether the changes occurred in non-smokers or in smokers, yet the effects of the ban are frequently attributed to reductions in second-hand smoke exposure. The lead author of the Ohio study agreed that a prospective study that collected data on groups of non-smokers and smokers in advance of a ban — and then followed them up for a few years after — would be ideal, but this would take longer and be costly." ...
Certainly, public-health officials seem convinced. Pechacek says that the general consensus in tobacco researchers is that the drop in heart attacks occurs mainly in non-smokers. Smokefree England suggests that just 30 minutes of breathing in second-hand smoke can raise your risk of having a heart attack. But can you really become ill just by sitting in a bar next to a smoker? 'Saying that just a little exposure is killing people is going overboard,' says Siegel, who worries that when researchers exaggerate their findings, they lose credibility with the public. 'I agree that second-hand smoke is a tremendous health hazard, but no one is going to have a heart attack from 30 minutes of exposure.'"
"Siegel thinks that banning smoking in outdoor places is going too far and risks losing support for smoking bans overall. Smoking has been banned on 25 California beaches, and this week the Beverly Hills City Council approved a ban in nearly all outdoor dining areas. 'We should focus efforts on the remaining areas in which workers are not protected,' he says. 'My biggest concern is for the waiters and bartenders who spend 40 hours each week in very smoky environments.' He's also worried about the health of smoking research itself, which he sees being compromised by methodological flaws and over-interpretation of results. And although prospective studies would be costly, Siegel argues that funding for a large prospective study of the effects of smoking bans on non-smokers is warranted. 'Although I wholeheartedly support smoking bans, I still believe that we must use solid science to advocate for such bans and that a noble end — improving public health — does not justify the compromise of our scientific principles.'"
The Rest of the Story
I don't have much to add to what Dr. Novak wrote. I'm just glad that the misrepresentation of the science by anti-smoking groups and the deterioration of the quality of the scientific conclusions being made in the movement are being highlighted in a scientific journal with the high quality and fine reputation of a journal like Nature. I hope this will force anti-smoking groups to re-examine their decisions to disseminate misleading, if not inaccurate, health information and encourage the tobacco control movement to take stock of the deterioration of its scientific integrity and take steps to restore it.
Unfortunately, I don't think either of these will happen, because frankly, I really don't think that the movement, as an entity, actually cares. As long as its political aims are being met, I don't think that scientific integrity really enters the picture.
Monday, November 19, 2007
New Data from Scottish National Health Service Show that Smoking Ban/Heart Attack Study Was Junk Science, Show Danger of Science by Press Release
New data released last week by the Scottish National Health Service reveal that the national smoking ban had no detectable effect on heart attack hospital admissions, despite an earlier claim made by University of Glasgow researchers and disseminated to the media via press release that the smoking ban resulted in a startling 17% decline in heart attacks.
The data, which are reported in an article by Michael Blastland published by the BBC News, were reported by the National Health Service's Informational Services Division. They include all hospital admissions for heart attack nationwide, reported as annual standardized rates. The data show a decline of about 8% in the year following the smoking ban, which is only slightly higher than the approximate 6% decline the year preceding the smoking ban.
If one looks at the trend in heart attack rates from 1998 through 2007, one finds that based on the pre-existing trends in heart attack rates, there has been no apparent change in the rate of heart attacks following the smoking ban, which was implemented in March 2006.
These data also confirm my earlier analysis, in which I pointed out that a huge decline in heart attacks in Scotland from 1999 to 2000 occurred prior to the smoking ban and reveal the large degree of baseline variability in the data, meaning that only a junk science study would conclude that the observed decline in heart attacks during the 10 months following the smoking ban was attributable to the smoking ban. In fact, the data released last week reveal that the largest drop in heart attack admission rates occurred not following the smoking ban, but from 1999 to 2000.
Blastland writes: "It was dramatic research that made headlines everywhere. A 17% fall in the number of heart attacks in the year since Scotland stubbed out smoking in public places. Startling - if true. Few questioned the research when it was revealed two months ago. ... Then a week ago, with rather less fanfare, routine statistics on hospital activity were published by the official source for health data in Scotland, as they are every year, this time including the time since the ban. These show a fall in heart attacks for the year from March 2006 - not of 17%, but less than half as much at about 8%. ... The percentage falls in the three years before the ban were 5.1%, 4.7% and 5.7%. ... The latest release also makes clear that even an 8% fall in heart attacks is not unprecedented. There was another, larger drop between 1999 and 2000 of about 11%. This seems to demonstrate significant variability around the trend, suggesting that last year's 8% drop might even be the result of chance. It is conceivable, although perhaps unlikely, that the smoking ban had no effect at all. The figures could be a result of no more than the ordinary ups and downs of statistical variation from one year to the next."
Blastland's observations are consistent with my commentary of September 13, in which I wrote:
"To see why a thorough review of the actual study is necessary, just look at the hospital discharge data for heart attacks in Scotland. We find evidence of a large single-year decline in heart attacks of about 10% which occurred in the absence of any smoking ban. This indicates that there can be a large year-to-year variation in heart attacks in Scotland and makes it especially difficult to determine whether a 17% annual decline in heart attacks is due in part to random variation, and if so, to what extent. From the information that was provided to us, it is impossible to conclude that the smoking ban was responsible for the observed decline in heart attack admissions."
"It is also important to consider the fact that the more rapid decline in heart attack admissions in Scotland appears to have begun prior to the smoking ban. A drop in heart attack admissions of 17% (equal to what was observed after the smoking ban) actually occurred during the three-month period immediately prior to the smoking ban. It would be very questionable to attribute the observed heart attack decline to the smoking ban in the face of this evidence that heart attacks were declining substantially prior to the ban. It is entirely possible that some other factor is responsible for the observed decline."
As it turns out, it does not even appear that there has been a change in the rate of decline in heart attack admissions in Scotland. Clearly, the conclusions drawn by the researchers and disseminated to the media and the public prior to peer review of their study were premature.
Despite issuing their press release, the researchers did not make their study available for public review and it appears that they are still not releasing it. Blastland reports that "because the data on which the StopIt study was based has never been published, and nor has the study itself, it is impossible to say exactly how it was done. Attempts to obtain it or to talk to the lead researcher have gone unanswered."
The Rest of the Story
There are two important implications of this story.
First, it demonstrates that tobacco control science is quickly deteriorating into junk science. I believe that investigator bias is becoming so strong that it is leading to completely invalid study conclusions. The Helena study conclusions, and now the conclusions from Pueblo, Piedmont, Bowling Green, Scotland, and Ireland, have all been cast into doubt. An apparently strong bias is clouding the scientific rigor of the papers being produced in this area. It represents, in my view, a true and unfortunate deterioration of the scientific integrity within the tobacco control movement.
Second, this story demonstrates the dangers of the science by press release approach which has now become the standard for these smoking ban/heart attack studies. It shows precisely why it is not prudent to issue findings that have not been validated by a peer review process. Suppose that upon peer review (or in this case, simply upon release of more complete data), it turns out that the study findings are unwarranted and invalid. Are the researchers going to then issue a press release stating that they were wrong, that their conclusion was premature and invalid, and that all news articles that the public throughout the world read to the contrary should be disregarded?
I highly doubt it. I doubt that the researchers of the Scotland heart attack study are going to pull an Emily Litella and issue a press release tomorrow saying: "Never mind."
The point is that the word is already out there. The conclusions have already been disseminated. It is too late to retract them now that they have been shown to be wrong.
This is why I view it to be inappropriate and unethical to release the results of a scientific study prior to peer review and publication. There is one exception, and that is IF (and only if) one makes the study available for public scrutiny and review. If you are going to go to the press to disseminate study findings, then you have to be willing to allow the public to see the study upon which those findings are based. Otherwise, there is no opportunity for review and scrutiny of your work.
In this case, the researchers apparently did not make their study available for public review and it appears that they still refuse to release it for public review.
The scientific standards of the tobacco control movement are rapidly crumbling. And the ethical standards don't seem to be that far behind.
The data, which are reported in an article by Michael Blastland published by the BBC News, were reported by the National Health Service's Informational Services Division. They include all hospital admissions for heart attack nationwide, reported as annual standardized rates. The data show a decline of about 8% in the year following the smoking ban, which is only slightly higher than the approximate 6% decline the year preceding the smoking ban.
If one looks at the trend in heart attack rates from 1998 through 2007, one finds that based on the pre-existing trends in heart attack rates, there has been no apparent change in the rate of heart attacks following the smoking ban, which was implemented in March 2006.
These data also confirm my earlier analysis, in which I pointed out that a huge decline in heart attacks in Scotland from 1999 to 2000 occurred prior to the smoking ban and reveal the large degree of baseline variability in the data, meaning that only a junk science study would conclude that the observed decline in heart attacks during the 10 months following the smoking ban was attributable to the smoking ban. In fact, the data released last week reveal that the largest drop in heart attack admission rates occurred not following the smoking ban, but from 1999 to 2000.
Blastland writes: "It was dramatic research that made headlines everywhere. A 17% fall in the number of heart attacks in the year since Scotland stubbed out smoking in public places. Startling - if true. Few questioned the research when it was revealed two months ago. ... Then a week ago, with rather less fanfare, routine statistics on hospital activity were published by the official source for health data in Scotland, as they are every year, this time including the time since the ban. These show a fall in heart attacks for the year from March 2006 - not of 17%, but less than half as much at about 8%. ... The percentage falls in the three years before the ban were 5.1%, 4.7% and 5.7%. ... The latest release also makes clear that even an 8% fall in heart attacks is not unprecedented. There was another, larger drop between 1999 and 2000 of about 11%. This seems to demonstrate significant variability around the trend, suggesting that last year's 8% drop might even be the result of chance. It is conceivable, although perhaps unlikely, that the smoking ban had no effect at all. The figures could be a result of no more than the ordinary ups and downs of statistical variation from one year to the next."
Blastland's observations are consistent with my commentary of September 13, in which I wrote:
"To see why a thorough review of the actual study is necessary, just look at the hospital discharge data for heart attacks in Scotland. We find evidence of a large single-year decline in heart attacks of about 10% which occurred in the absence of any smoking ban. This indicates that there can be a large year-to-year variation in heart attacks in Scotland and makes it especially difficult to determine whether a 17% annual decline in heart attacks is due in part to random variation, and if so, to what extent. From the information that was provided to us, it is impossible to conclude that the smoking ban was responsible for the observed decline in heart attack admissions."
"It is also important to consider the fact that the more rapid decline in heart attack admissions in Scotland appears to have begun prior to the smoking ban. A drop in heart attack admissions of 17% (equal to what was observed after the smoking ban) actually occurred during the three-month period immediately prior to the smoking ban. It would be very questionable to attribute the observed heart attack decline to the smoking ban in the face of this evidence that heart attacks were declining substantially prior to the ban. It is entirely possible that some other factor is responsible for the observed decline."
As it turns out, it does not even appear that there has been a change in the rate of decline in heart attack admissions in Scotland. Clearly, the conclusions drawn by the researchers and disseminated to the media and the public prior to peer review of their study were premature.
The researchers who conducted the study had issued a press release on September 10, in which they highlighted the conclusion that there had been a 17% decline in heart attacks which was largely attributable to the smoking ban. The media widely disseminated this conclusion, with headlines such as: "Scottish Smoking Ban Leads to Huge Drop in Heart Attacks."
Despite issuing their press release, the researchers did not make their study available for public review and it appears that they are still not releasing it. Blastland reports that "because the data on which the StopIt study was based has never been published, and nor has the study itself, it is impossible to say exactly how it was done. Attempts to obtain it or to talk to the lead researcher have gone unanswered."
The Rest of the Story
There are two important implications of this story.
First, it demonstrates that tobacco control science is quickly deteriorating into junk science. I believe that investigator bias is becoming so strong that it is leading to completely invalid study conclusions. The Helena study conclusions, and now the conclusions from Pueblo, Piedmont, Bowling Green, Scotland, and Ireland, have all been cast into doubt. An apparently strong bias is clouding the scientific rigor of the papers being produced in this area. It represents, in my view, a true and unfortunate deterioration of the scientific integrity within the tobacco control movement.
Second, this story demonstrates the dangers of the science by press release approach which has now become the standard for these smoking ban/heart attack studies. It shows precisely why it is not prudent to issue findings that have not been validated by a peer review process. Suppose that upon peer review (or in this case, simply upon release of more complete data), it turns out that the study findings are unwarranted and invalid. Are the researchers going to then issue a press release stating that they were wrong, that their conclusion was premature and invalid, and that all news articles that the public throughout the world read to the contrary should be disregarded?
I highly doubt it. I doubt that the researchers of the Scotland heart attack study are going to pull an Emily Litella and issue a press release tomorrow saying: "Never mind."
The point is that the word is already out there. The conclusions have already been disseminated. It is too late to retract them now that they have been shown to be wrong.
This is why I view it to be inappropriate and unethical to release the results of a scientific study prior to peer review and publication. There is one exception, and that is IF (and only if) one makes the study available for public scrutiny and review. If you are going to go to the press to disseminate study findings, then you have to be willing to allow the public to see the study upon which those findings are based. Otherwise, there is no opportunity for review and scrutiny of your work.
In this case, the researchers apparently did not make their study available for public review and it appears that they still refuse to release it for public review.
The scientific standards of the tobacco control movement are rapidly crumbling. And the ethical standards don't seem to be that far behind.
Saturday, October 20, 2007
IN MY VIEW: Why Has The Tobacco Control Movement Lost Its Scientific Integrity?
In this post, I address two questions that have been asked by a number of readers and by several reporters since the publication of my article in Epidemiologic Perspectives & Innovations, which concludes that many anti-smoking groups are misrepresenting the acute cardiovascular health effects of secondhand smoke:
1. Did this misrepresentation of the science just start, or has it been going on for some time?
2. If the misrepresentation of the science has been increasing over time, why?
My answer to the first question is that while some misrepresentation of the science may have been occurring for some time, there has, without a doubt, been a dramatic increase in the amount of this misrepresentation. Without question, it is over the past six years, from 2001 forward, that I have observed a complete loss of scientific integrity within the tobacco control movement.
My answer to the second question is that the loss of scientific integrity in tobacco control coincides perfectly with the abdication by the tobacco industry of its role as a watchdog for "anti-tobacco industry" statements and communications.
In essence, the role that I am now playing is one that the tobacco industry used to play, albeit for a different reason. The tobacco industry played a watchdog role because they wanted to discredit tobacco control and undermine its public credibility. I am now playing this watchdog role because I want to restore the scientific integrity of the movement and save its public credibility. Nevertheless, the role that I am playing is very similar to what the tobacco industry used to do.
To some extent, it is surprising to me that the tobacco companies have not made more of a public display over the outright misrepresentation of science by anti-smoking groups. I suppose they feel that if they just lay back, the movement will destroy its own credibility. This may be a wise strategy, since it seems that every day, the claims get more and more absurd (wait until you read Monday's post).
First it was 30 minutes of secondhand smoke being fatal, then 20 minutes, then 5 minutes, and then basically instantaneous death from a trace of secondhand smoke.
First it was Helena, then Pueblo, then Piedmont, then Bowling Green, and now Scotland and Ireland.
First it was 120,000 deaths from exposure to smoking in movies and now it's 120,000 deaths from exposure to even a single depiction of smoking in movies.
If left to their own devices, it appears that the tobacco control movement will continue to spiral out of control in their misrepresentations of science, and eventually, they will go too far and lose public credibility. It's a good thing that somebody is trying to hold the movement accountable for its statements.
I remember, back before 2001, that whenever we wanted to make a public statement, we would quake in our boots over what the tobacco industry's reaction might be. We pored over every word of every statement we made because we were scared. We were scared of being nailed by the tobacco industry. The industry was watching every word we said and they would nail us to a tree if we took any mis-steps. So we were exceedingly careful.
Around the year 2000 or so, coinciding with the change in the public position of the tobacco companies over the health effects of smoking, the implementation of the Master Settlement Agreement, the Engle decision and the tobacco industry's attempt to portray itself to the jury in a new light, the dissolution of the Tobacco Institute, and the attempt of the tobacco industry to create a new public image in light of damaging publicity from lawsuits, it appears to me that the industry made a decision to lay off its constant vigilance over the communications of anti-smoking groups.
Gone were the days of constant FOIA requests to anti-smoking groups, which had gotten us to watch every word we said, even in non-public communications. Gone were the days of having to worry about actually being held to our public statements. Gone were the days of having to actually defend our statements publicly, and to take public responsibility for them.
This is the new era of tobacco control - sans industry oversight.
And it has truly become a free-for-all for anti-smoking organizations.
Imagine this: the anti-smoking groups can actually claim that 30 minutes of secondhand smoke exposure is enough to cause hardening of the arteries. They can actually claim that 30 minutes of secondhand smoke exposure increases your risk of a fatal heart attack to the same level as that of an active smoker. They can actually claim that 2 hours of secondhand smoke increases your risk of sudden death from a cardiac arrhythmia.
And they can get away with it.
That's why I think the anti-smoking groups have lost their scientific integrity. Because they can get away with it.
1. Did this misrepresentation of the science just start, or has it been going on for some time?
2. If the misrepresentation of the science has been increasing over time, why?
My answer to the first question is that while some misrepresentation of the science may have been occurring for some time, there has, without a doubt, been a dramatic increase in the amount of this misrepresentation. Without question, it is over the past six years, from 2001 forward, that I have observed a complete loss of scientific integrity within the tobacco control movement.
My answer to the second question is that the loss of scientific integrity in tobacco control coincides perfectly with the abdication by the tobacco industry of its role as a watchdog for "anti-tobacco industry" statements and communications.
In essence, the role that I am now playing is one that the tobacco industry used to play, albeit for a different reason. The tobacco industry played a watchdog role because they wanted to discredit tobacco control and undermine its public credibility. I am now playing this watchdog role because I want to restore the scientific integrity of the movement and save its public credibility. Nevertheless, the role that I am playing is very similar to what the tobacco industry used to do.
To some extent, it is surprising to me that the tobacco companies have not made more of a public display over the outright misrepresentation of science by anti-smoking groups. I suppose they feel that if they just lay back, the movement will destroy its own credibility. This may be a wise strategy, since it seems that every day, the claims get more and more absurd (wait until you read Monday's post).
First it was 30 minutes of secondhand smoke being fatal, then 20 minutes, then 5 minutes, and then basically instantaneous death from a trace of secondhand smoke.
First it was Helena, then Pueblo, then Piedmont, then Bowling Green, and now Scotland and Ireland.
First it was 120,000 deaths from exposure to smoking in movies and now it's 120,000 deaths from exposure to even a single depiction of smoking in movies.
If left to their own devices, it appears that the tobacco control movement will continue to spiral out of control in their misrepresentations of science, and eventually, they will go too far and lose public credibility. It's a good thing that somebody is trying to hold the movement accountable for its statements.
I remember, back before 2001, that whenever we wanted to make a public statement, we would quake in our boots over what the tobacco industry's reaction might be. We pored over every word of every statement we made because we were scared. We were scared of being nailed by the tobacco industry. The industry was watching every word we said and they would nail us to a tree if we took any mis-steps. So we were exceedingly careful.
Around the year 2000 or so, coinciding with the change in the public position of the tobacco companies over the health effects of smoking, the implementation of the Master Settlement Agreement, the Engle decision and the tobacco industry's attempt to portray itself to the jury in a new light, the dissolution of the Tobacco Institute, and the attempt of the tobacco industry to create a new public image in light of damaging publicity from lawsuits, it appears to me that the industry made a decision to lay off its constant vigilance over the communications of anti-smoking groups.
Gone were the days of constant FOIA requests to anti-smoking groups, which had gotten us to watch every word we said, even in non-public communications. Gone were the days of having to worry about actually being held to our public statements. Gone were the days of having to actually defend our statements publicly, and to take public responsibility for them.
This is the new era of tobacco control - sans industry oversight.
And it has truly become a free-for-all for anti-smoking organizations.
Imagine this: the anti-smoking groups can actually claim that 30 minutes of secondhand smoke exposure is enough to cause hardening of the arteries. They can actually claim that 30 minutes of secondhand smoke exposure increases your risk of a fatal heart attack to the same level as that of an active smoker. They can actually claim that 2 hours of secondhand smoke increases your risk of sudden death from a cardiac arrhythmia.
And they can get away with it.
That's why I think the anti-smoking groups have lost their scientific integrity. Because they can get away with it.
Thursday, February 14, 2008
New Study Concludes that Italian Smoking Ban Reduced Heart Attack Rates Within First Year
An article published online ahead of print in the journal Circulation concludes that the ban on smoking in public places in Italy has resulted in an 8%-11% decline in acute coronary events (i.e., heart attacks) in the first year following implementation of the ban (see: Cesaroni G, Forastiere F, Agabiti N, et al. Effect of the Italian Smoking Ban on Population Rates of Acute Coronary Events. Circulation 2008).
The study compared the annual age-standardized rates of acute coronary events among adults in three different age groups during the five years preceding the smoking ban (2000-2004) to the rates during the first year the ban was in effect (2005). The post-smoking ban acute coronary event rate was 11% lower than the pre-ban rate for adults ages 35-64 and 8% lower for adults ages 65-74. There was no significant difference in the pre- and post-ban rates for adults ages 75-84.
The authors conclude that the observed reduction in the heart attack rate in 2005 among 35-74 year-olds was atributable to the smoking ban. Furthermore, the authors conclude that at least a portion of the effect is due to a reduction in secondhand smoke exposure among nonsmokers.
One study author stated: "Smoking bans in all public and workplaces result in an important reduction of acute coronary events."
These conclusions have been widely reported. For example, this article was headlined: "Public smoking ban decreases acute coronary events in Italy."
Results of this and related studies (with similar methodology) are being used by anti-smoking advocates in testimony before policy makers that smoking bans have an immediate effect on heart attack rates.
The Rest of the Story
There's just one problem with all of this: the conclusions of this study are not supported by the data. The data clearly show that the decline in heart attack rates among adults in these two age groups began prior to the implementation of the smoking ban. Thus, it is evident that the decline is not attributable to the smoking ban.
Take a look at the data for yourself:
A. Age 65-74
From 2003 to 2004 (prior to the smoking ban), the heart attack rate declined from 7.86 to 7.39, a drop of 6.0%.
From 2004 to 2005 (first year of the smoking ban), the heart attack rate declined from 7.39 to 6.95, a drop of 6.0%.
In other words, the decline in the heart attack rate from 2003 to 2004 was exactly the same as the decline from 2004 to 2005.
These data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. Instead, these data document that the decline in the heart attack rate in this age group was exactly the same post-ban as it was pre-ban.
In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.
The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.
B. Age 35-64
From 2002 to 2003 (prior to the smoking ban), the heart attack rate declined from 2.13 to 1.95, a drop of 8.5%.
From 2004 to 2005 (the first year of the smoking ban), the heart attack rate declined from 1.92 to 1.80, a drop of 6.3%.
In other words, the observed decline in the heart attack rate one year prior to the smoking ban was actually greater than the decline in the heart attack rate after the smoking ban.
The average decline in the heart attack rate for the two year period preceding the smoking ban (2002 to 2004) was 4.9%.
The decline in the heart attack rate for the first year following the smoking ban was 6.4%.
Thus, one can see that the decline in the heart attack rate in this age group after the smoking ban was comparable to the decline in the heart attack rate in this age group before the smoking ban.
Once again, these data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. If anything, these data document that the decline in the heart attack rate in this age group was about the same post-ban as it was pre-ban.
In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.
The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. Again, I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.
What is so alarming about the conclusion of this Italian smoking ban study is not so much that the authors have drawn a conclusion that follows from the data but have failed to consider alternative explanations for the cause of the decline in heart attack rates. What is so alarming is that they have drawn a conclusion that is completely unsupported by the data itself.
In other words, what appears to be operating here is an investigator bias, by which the authors seem to have been determined to find an effect even if one did not exist. It appears that this bias probably skewed their judgment in evaluating these data.
If you want to see what I mean, plot the heart attack rates for yourself on a graph. I used Microsoft Excel to do this and it took just a few minutes.
Then, examine the trend in heart attack rates among the age groups visually. For the 35-64 year-old group, you will readily see that there is literally a straight line from 2002 to 2005. There is an apparent decline in the heart attack rate that has remained relatively stable during the past few years. But that decline started in 2002, not in 2004.
Similarly, if you look at the graph for the 65-74 year-old group, you will see that there is literally a straight line from 2003 to 2005. There is indeed a trend of a declining heart attack rate, but that decline starts in 2003.
The appropriate conclusion from these data is that there is indeed a significant decline in the heart attack rates among 35-74 year-olds, but that this decline preceded the implementation of the smoking ban. The smoking ban certainly does not seem to have done anything to alter the existing observed declines.
This does not prove that the smoking ban had no effect. But what it does is indicate that the conclusion of the study is completely invalid.
There is another serious problem which, independently of the improperly interpreted data, renders the study conclusion invalid. That problem is simple: there is no comparison group. Without a comparison group, it is impossible to know whether the observed changes in heart attack rates in Italy are unique to Italy or whether they mirror similar secular changes occurring elsewhere.
We happen to know, for example, that in the United States, there have been substantial declines in heart attack rates - even in states without smoking bans - during the same time period. There is no way that the study can conclude that the observed decline in Italy is not simply a reflection of the underlying secular trend of declining coronary event rates that is occurring anyway, even in the absence of the smoking ban.
What I find highly intriguing is the apparent bias that is plaguing the interpretation of these smoking ban/heart attack studies, from Helena to Pueblo to Saskatoon to Bowling Green to Ireland to Scotland to Piedmont to Rome.
What I think this shows is that if one wants strongly enough to be able to find an effect of something, that can skew ones interpretation and analysis of the data such that one is able to do so. That is somewhat reasonable, since there is always going to be an inherent bias in any scientific study.
But what is not so reasonable to me is that these inherent biases and the skewed and invalid interpretation of the data are not being picked up by journals. It suggests that perhaps the peer reviewers who are being chosen to review these studies are affected by the same bias. If these papers are not being reviewed by scientists who are neutral, then those reviewers are far less likely to pick up the glaring flaws in these study conclusions. It certainly appears that may have been what happened in the case of Rome.
The study compared the annual age-standardized rates of acute coronary events among adults in three different age groups during the five years preceding the smoking ban (2000-2004) to the rates during the first year the ban was in effect (2005). The post-smoking ban acute coronary event rate was 11% lower than the pre-ban rate for adults ages 35-64 and 8% lower for adults ages 65-74. There was no significant difference in the pre- and post-ban rates for adults ages 75-84.
The authors conclude that the observed reduction in the heart attack rate in 2005 among 35-74 year-olds was atributable to the smoking ban. Furthermore, the authors conclude that at least a portion of the effect is due to a reduction in secondhand smoke exposure among nonsmokers.
One study author stated: "Smoking bans in all public and workplaces result in an important reduction of acute coronary events."
These conclusions have been widely reported. For example, this article was headlined: "Public smoking ban decreases acute coronary events in Italy."
Results of this and related studies (with similar methodology) are being used by anti-smoking advocates in testimony before policy makers that smoking bans have an immediate effect on heart attack rates.
The Rest of the Story
There's just one problem with all of this: the conclusions of this study are not supported by the data. The data clearly show that the decline in heart attack rates among adults in these two age groups began prior to the implementation of the smoking ban. Thus, it is evident that the decline is not attributable to the smoking ban.
Take a look at the data for yourself:
A. Age 65-74
From 2003 to 2004 (prior to the smoking ban), the heart attack rate declined from 7.86 to 7.39, a drop of 6.0%.
From 2004 to 2005 (first year of the smoking ban), the heart attack rate declined from 7.39 to 6.95, a drop of 6.0%.
In other words, the decline in the heart attack rate from 2003 to 2004 was exactly the same as the decline from 2004 to 2005.
These data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. Instead, these data document that the decline in the heart attack rate in this age group was exactly the same post-ban as it was pre-ban.
In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.
The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.
B. Age 35-64
From 2002 to 2003 (prior to the smoking ban), the heart attack rate declined from 2.13 to 1.95, a drop of 8.5%.
From 2004 to 2005 (the first year of the smoking ban), the heart attack rate declined from 1.92 to 1.80, a drop of 6.3%.
In other words, the observed decline in the heart attack rate one year prior to the smoking ban was actually greater than the decline in the heart attack rate after the smoking ban.
The average decline in the heart attack rate for the two year period preceding the smoking ban (2002 to 2004) was 4.9%.
The decline in the heart attack rate for the first year following the smoking ban was 6.4%.
Thus, one can see that the decline in the heart attack rate in this age group after the smoking ban was comparable to the decline in the heart attack rate in this age group before the smoking ban.
Once again, these data clearly do not support the conclusion that the smoking ban resulted in a sudden drop in the heart attack rate. If anything, these data document that the decline in the heart attack rate in this age group was about the same post-ban as it was pre-ban.
In light of these data, I find it impossible and highly invalid to conclude that the smoking ban resulted in the observed decline in heart attacks from 2004 to 2005. A more likely, and certainly plausible, explanation is that there was already a trend of declining heart attack rates and that this trend simply continued from 2004 to 2005.
The precise reasoning being used by this paper could equally be used to argue that the smoking ban had no effect on heart attacks. Again, I'm not making such a claim, but I am suggesting that these data by no means support the conclusion of the article. In fact, they refute such a conclusion.
What is so alarming about the conclusion of this Italian smoking ban study is not so much that the authors have drawn a conclusion that follows from the data but have failed to consider alternative explanations for the cause of the decline in heart attack rates. What is so alarming is that they have drawn a conclusion that is completely unsupported by the data itself.
In other words, what appears to be operating here is an investigator bias, by which the authors seem to have been determined to find an effect even if one did not exist. It appears that this bias probably skewed their judgment in evaluating these data.
If you want to see what I mean, plot the heart attack rates for yourself on a graph. I used Microsoft Excel to do this and it took just a few minutes.
Then, examine the trend in heart attack rates among the age groups visually. For the 35-64 year-old group, you will readily see that there is literally a straight line from 2002 to 2005. There is an apparent decline in the heart attack rate that has remained relatively stable during the past few years. But that decline started in 2002, not in 2004.
Similarly, if you look at the graph for the 65-74 year-old group, you will see that there is literally a straight line from 2003 to 2005. There is indeed a trend of a declining heart attack rate, but that decline starts in 2003.
The appropriate conclusion from these data is that there is indeed a significant decline in the heart attack rates among 35-74 year-olds, but that this decline preceded the implementation of the smoking ban. The smoking ban certainly does not seem to have done anything to alter the existing observed declines.
This does not prove that the smoking ban had no effect. But what it does is indicate that the conclusion of the study is completely invalid.
There is another serious problem which, independently of the improperly interpreted data, renders the study conclusion invalid. That problem is simple: there is no comparison group. Without a comparison group, it is impossible to know whether the observed changes in heart attack rates in Italy are unique to Italy or whether they mirror similar secular changes occurring elsewhere.
We happen to know, for example, that in the United States, there have been substantial declines in heart attack rates - even in states without smoking bans - during the same time period. There is no way that the study can conclude that the observed decline in Italy is not simply a reflection of the underlying secular trend of declining coronary event rates that is occurring anyway, even in the absence of the smoking ban.
What I find highly intriguing is the apparent bias that is plaguing the interpretation of these smoking ban/heart attack studies, from Helena to Pueblo to Saskatoon to Bowling Green to Ireland to Scotland to Piedmont to Rome.
What I think this shows is that if one wants strongly enough to be able to find an effect of something, that can skew ones interpretation and analysis of the data such that one is able to do so. That is somewhat reasonable, since there is always going to be an inherent bias in any scientific study.
But what is not so reasonable to me is that these inherent biases and the skewed and invalid interpretation of the data are not being picked up by journals. It suggests that perhaps the peer reviewers who are being chosen to review these studies are affected by the same bias. If these papers are not being reviewed by scientists who are neutral, then those reviewers are far less likely to pick up the glaring flaws in these study conclusions. It certainly appears that may have been what happened in the case of Rome.
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