Data from Australia Show No Effect of Smoking Bans on Heart Attack Admissions

National data from all hospital admissions in Australia show no apparent effect of smoking bans that were enacted in the various Australian states between 2005 and 2007. The data are easily available online and Christopher Snowdon over at Velvet Glove, Iron Fist has produced graphs of long-term trends in heart attack admissions in Australia before and after these smoking bans. He provides analyses of both the national trend in heart attack admissions and in the state-specific heart attack trends, showing with an arrow the point at which the smoking ban became active in each of the states.

There is no apparent effect of the smoking ban on heart attack admissions in any of the states. The most important pieces of data are those for New South Wales and Victoria, because they contain the largest populations. In both, there was no apparent effect of the smoking ban on heart attacks. If anything, there was an increase in heart attacks associated with the first nine months of implementation of the smoking bans in those states.

As Snowdon notes: "Note that the Helena hypothesis specifically claimed a drop in heart attacks of 40% within the first six months of the ban. Although Victoria and New South Wales introduced their bans towards the end of the time-frame, there was still nine months between July 2007 and March 2008 for a drop in heart attacks to occur. Instead, the rate rose from 51,667 to 55,676 between 2006/07 and 2007/08."

These results are in accordance with the observations of several tobacco researchers in Australia who have previously told me that they failed to see any significant effect of smoking bans there on heart attack trends.

The Rest of the Story

Today's story adds to the list of states and countries for which national or state-specific data show no effect of the smoking ban, bringing the total up to 10. The strength of these data is that the entire country or state is included (there is no sampling), there is little concern about heart attack cases that may have presented to out-of-town hospitals, and the populations involved are quite large, helping to protect against random fluctuations in the data which could present the false appearance of a large increase or decrease in heart attacks from one year to the next.

As Snowdon writes, reflecting a similar sentiment about the importance of these population-based, large studies of national or state-specific data: "It would, however, be nice to think that journalists might ask themselves whether data collected by professional tobacco control advocates from obscure towns really trumps genuine hospital admissions data collected by professional statisticians from entire nations."

The fact that the largest declines in heart attacks in the published studies occurred in the smallest of communities and that data for every state or country studied so far fails to confirm any significant short-term effect of smoking bans on heart attacks argues against the validity of the conclusion reached by the Institute of Medicine (IOM) committee, which failed to examine the readily available heart attack admissions data from any of these 10 states and/or countries.

It is quite clear that the IOM report failed to provide any review of these unpublished data. Nevertheless, the committee claimed that it had comprehensively reviewed the unpublished data: the press release states: "The IOM committee conducted a comprehensive review of published and unpublished data and testimony on the relationship between secondhand smoke and short-term and long-term heart problems."

In my opinion, the premature rush to judgment by anti-smoking researchers and groups on the issue of smoking bans and heart attacks undermines both the scientific integrity and the scientific credibility of the tobacco control movement.

While the conclusions of anti-smoking groups about the smoking ban and heart attack studies is receiving widespread publicity, so is the criticism of these groups' unsupported pronouncements. For example, an op-ed in Sunday's New York Post by Jacob Sullum -- a senior editor of Reason Magazine -- calls the IOM committee out for its sloppy and biased review of the data.

Sullum writes: "a closer look at the IOM report, which was commissioned by the US Centers for Disease Control and Prevention, suggests its conclusions are based on a desire to promote smoking bans rather than a dispassionate examination of the evidence. Thousands of jurisdictions around the world restrict smoking. Some of them are bound to see significant drops in heart attacks purely by chance, while others will see no real change or significant increases. Focusing on the first group proves nothing unless it is noticeably bigger than the other two groups. The largest study of this issue, which used nationwide data instead of looking at cherry-picked communities, concluded that smoking bans in America "are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction." ... That study, published by the National Bureau of Economic Research in March, suggests that publication bias -- the tendency to report positive findings and ignore negative ones -- explains the "consistent" results highlighted by the IOM committee. But even though the panelists say they tried to compensate for publication bias by looking for relevant data that did not appear in medical journals, they ignored the NBER paper, along with analyses that found no declines in heart attacks following smoking bans in California, Florida, New York, Oregon, England, Wales and Scotland." ...

"when people stop smoking, their heart-attack risk declines gradually over several years, and it's hard to see why the risk would fall any faster for people exposed to secondhand smoke. Furthermore, estimates from the CDC and the American Heart Association indicate that smoking and secondhand smoke together account for about 25 percent of heart-disease deaths. So how could a smoking ban, even one that eliminated all smoking, cut heart attacks by 40 percent (or 47 percent, as another study claimed)? The IOM panelists dodge these issues by declining to estimate the size or the timing of the impact from smoking bans, citing the limitations of the studies and the wide variations between them. But "if you can't even estimate the magnitude of an effect," notes Michael Siegel, a Boston University public-health professor who was one of the report's reviewers, "you are hardly in a position to conclude that [it] exceeds random variation combined with the known secular decline in heart-attack rates." ... Siegel, who faults the IOM committee's "sensationalistic" approach, is a longtime backer of smoking bans who nevertheless tries to separate his political advocacy from his scientific analysis. It's too bad the authors of the IOM report, who immediately used it as an excuse to demand strict smoking regulations throughout the country, did not follow his example."

It pains me to see the scientific integrity of the tobacco control movement imploding like this. While I support the same goal of protecting the public from secondhand smoke exposure (though not the agenda of spreading smoking bans to the wide-open outdoors), I think the scientific credibility of public health groups is our most prized possession. To squander that in an attempt to promote even a valuable public health policy is foolish. But more importantly, misrepresenting the scientific evidence to the public is, I believe, unethical. It is inconsistent with the ethical code of conduct of public health.

IOM Report Criticized for Failing to Consider Relevant Data, Coming to Pre-Determined Conclusion

Over at Reason Magazine's Hit & Run blog, Jacob Sullum has criticized the Institute of Medicine (IOM) report on smoking bans and heart attacks for failing to consider relevant data and for reaching a pre-determined conclusion. In a post which he wittily but aptly entitles "Myocardial Infractions," Sullum describes how the IOM report not only failed to consider unpublished data which did not support the report's conclusion, but also drew conclusions that were inconsistent with the assertions made in the report itself.

While I had previously criticized the report for failing to consider unpublished, but relevant and significant data from Scotland, England, and Wales, Sullum points out that there are additional data from California, New York, Florida, Oregon, and the United States as a whole that were not considered and which do not support the report's conclusion that smoking bans result in substantial, short-term declines in heart attacks.

Sullum writes: "a closer look at the IOM report, which was commissioned by the U.S. Centers for Disease Control and Prevention, suggests its conclusions are based on a desire to promote smoking bans rather than a dispassionate examination of the evidence. Thousands of jurisdictions around the world restrict smoking. Some of them are bound to see significant drops in heart attacks purely by chance, while others will see no real change or significant increases. Focusing on the first group proves nothing unless it is noticeably bigger than the other two groups. The largest study of this issue, which used nationwide data instead of looking at cherry-picked communities, concluded that smoking bans in the U.S. "are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction." It also found that "large short-term increases in myocardial infarction incidence following a workplace ban are as common as the large decreases reported in the published literature." That study, published by the National Bureau of Economic Research (NBER) in March, suggests that publication bias—the tendency to report positive findings and ignore negative ones—explains the "consistent" results highlighted by the IOM committee. But even though the panelists say they tried to compensate for publication bias by looking for relevant data that did not appear in medical journals, they ignored the NBER paper, along with analyses that found no declines in heart attacks following smoking bans in California, Florida, New York, Oregon, England, Wales, Scotland, and Denmark."

Sullum also points out that although the report emphasized that few (only two) of the studies actually looked separately at heart attacks among smokers and nonsmokers, it nevertheless concludes that smoking bans specifically reduce heart attacks among nonsmokers by reducing acute secondhand smoke exposure. As Sullum writes: "If smoking bans reduce heart attacks, the effect could be due to declines in smoking, declines in secondhand smoke exposure, or both. The IOM report settles on that last explanation, quite a leap given that 'only two of the studies distinguished between reductions in heart attacks suffered by smokers versus nonsmokers.'"

Sullum concludes: "Siegel, who faults the IOM committee’s "sensationalistic" approach, is a longtime supporter of smoking bans who nevertheless tries to separate his political advocacy from his scientific analysis. It’s too bad the authors of the IOM report, who immediately used it as an excuse to demand strict smoking regulations throughout the country, did not follow his example."

The Rest of the Story

Occasionally, a review of data on an epidemiologic issue will miss one or two studies. But in the case of the IOM report on smoking bans and heart attacks, the report fails to consider relevant, objective, population-based data from the following, each of which fails to find any effect of smoking bans on heart attacks, in the short-term:

1. Scotland
2. England
3. Wales
4. Denmark
5. Florida
6. California
7. Oregon
8. New York
9. United States

The IOM committee states that it did not consider the data from these nine states or countries because they were unpublished. In an email, a committee member states: "The data from England, Scotland and Wales and their analyses referred to in your email are not found in the peer-reviewed literature and, therefore, were not reviewed in the committee’s report. It was beyond the scope of our study to seek out data available from all the municipalities, counties, states or countries that might be relevant to smoking bans and to conduct our own original studies."

In another email, a committee member acknowledges that he had not even seen the relevant data referred to above.

It seems clear that the committee did not consider these unpublished data in its report.

However, the press release states: "The IOM committee conducted a comprehensive review of published and unpublished data and testimony on the relationship between secondhand smoke and short-term and long-term heart problems."

If the report failed to consider the unpublished data and at least one of the committee members acknowledges not having even looked at that data, then why does the press release untruthfully state that the committee conducted a comprehensive review of unpublished data? How comprehensive a review is one in which the data are apparently not even examined? How comprehensive a review is it if the unpublished data are not even mentioned in the report?

The committee is of course free to restrict its analysis to published data, but you can't have it both ways. You can't restrict your analysis to published data and then lie to the the public and tell them that you comprehensively reviewed the unpublished data as well.

Why not just tell the truth and state that you examined only published data, not unpublished data? Why is it that tobacco control groups seem to have so much trouble these days simply telling the truth?

The rest of the story is that the IOM report failed to consider important, significant, and relevant unpublished data from nine different states or countries which do not support the conclusion of a significant short-term reduction in heart attacks from smoking bans. This has resulted in a severe bias in the report because of the presence of publication bias: clearly, only the positive studies are being published. This throws the report's conclusions into serious doubt.

But the other aspect to the rest of the story is that rather than simply acknowledge that they failed to examine unpublished data, the committee has essentially lied to the public by claiming that it conducted a comprehensive review of the unpublished data. Bias is one thing, but dishonesty is quite another.

Conclusion of IOM Report on Smoking Bans and Heart Attacks is Invalid on its Face: An Epidemiologic Analysis of the Report's Major Conclusion

Last week, an Institute of Medicine (IOM) committee released a report whose major conclusion was that smoking bans have a significant short-term effect on heart attacks, reducing the incidence of acute coronary event admissions to hospitals due in part to reduced secondhand smoke exposure. The press release headline read: "Smoking bans reduce the risk of heart attacks associated with secondhand smoke."

Although the report's conclusions have received widespread publicity, a little-noticed but severe flaw in the basic epidemiology/biostatistics foundation of the report renders its conclusion invalid.

In this commentary, I attempt to explain the nature of this flaw and why it renders the report's conclusion invalid.

The Rest of the Story

The report was very clear in asserting that the committee could draw no conclusion about the magnitude of the effect of smoking bans in reducing heart attack admissions. In fact, the report made it clear that the committee had no confidence in even estimating the magnitude of this effect.

According to the report: "However, because of the weaknesses discussed above and the variability among the studies, the committee has little confidence in the magnitude of the effects and, therefore, thought it inappropriate to attempt to estimate an effect size from such disparate designs and measures."

In other words, what the committee is saying is they have no confidence in making any estimate of the size of an effect of smoking bans on heart attack rates.

In epidemiology/biostatistics, we call this the "point estimate." The point estimate is the estimate of the magnitude of a particular association or effect. In other words, what is the estimate of the percentage by which smoking bans reduce heart attacks? Is it 4%, 10%, 20%, 47%?

The report makes it clear that we have no idea and that the studies are plagued with weaknesses such that there is no confidence in even making an estimate of the effect of smoking bans on heart attacks.

Note that I am not drawing my own conclusion about the quality of the studies. I am merely repeating what the report itself concludes.

Now, despite failing to be able to even guess what the point estimate might be, the report nevertheless clearly concludes that smoking bans cause a significant decrease in heart attacks. What this means is that the committee is certain that the 95% confidence interval around the point estimate for the effect of smoking bans does not include zero.

Suppose that the point estimate was 20%. Can one conclude that the effect on heart attacks is significant? It depends on the variability of the point estimate, which we can indicate through a confidence interval. With 95% certainty, what range are we sure that the actual point estimate falls into?

Suppose that the 95% confidence interval goes from 15% to 25%. Then, while we're not exactly sure whether the true effect is 15%, 20%, or 25%, we are sure that the effect is no lower than 15%, and we certainly know that it is greater than 0%. In other words, we can conclude that there is a significant effect of smoking bans on heart attacks.

In contrast, suppose that the 95% confidence interval goes from -5% to 50%. While we think the best estimate of the effect is a reduction of 20%, it could be anywhere between an increase of 5% and a reduction of 50%. The confidence interval includes zero (0%), meaning that we cannot conclude that there is a significant effect of smoking bans on heart attacks, because it is possible that the true effect is zero.

I hope readers see that in order to conclude that there is a significant effect of smoking bans in reducing heart attacks, one would have to derive a confidence interval and that confidence interval could not include zero. Another way of saying this is that the "lower bound" of the confidence interval would have to be greater than zero.

In essence, what the IOM report is concluding is that we have no idea what the point estimate for the reduction of heart attacks by smoking bans is, but we are nevertheless sure that the lower bound of the confidence interval around that point estimate does not go down as far as zero.

But there's two problems here.

First, you can't estimate the confidence interval unless you make some guess about the variability around the point estimate of the purported effect. If you haven't estimated a confidence interval, then you can't possibly conclude that the confidence interval doesn't include zero.

Second, if you can't even take a guess at a point estimate, then even if you know the variability around that estimate, you can't figure out the lower bound of the confidence interval, because you don't know where to start counting down from.

In other words, if you are not able to make a point estimate, then you have no way of knowing what the lower bound of the confidence interval is.

Do you see that the IOM report's conclusion is based on a complete leap of faith? What the report is saying is that we have no idea what the lower bound of the confidence interval is; however, we are nevertheless certain that it does not extend down as far as zero.

This is equivalent to drawing a pre-determined conclusion. If you are not willing to actually see what the true confidence interval is before drawing a causal conclusion, then you might as well just draw your conclusion prior to doing the actual review. It is a leap of faith, because it is accepting something without empirical evidence.

The committee provides no evidence about what the lower bound of the confidence interval is and it makes no attempt to estimate either a point estimate or a lower bound of the confidence interval around that estimate. Nevertheless, despite the complete absence of any empirical evidence of what that lower bound is, they are quite certain that the lower bound is greater than zero.

Note that I am not, in this commentary, even getting into the issue of how the failure to consider unpublished, but highly reliable, meaningful, relevant, and population-representative data from Scotland, England, Wales, Denmark, and the United States as a whole would lead to a biased point estimate. I am just noting that even taking the report's conclusions as a given, its ultimate conclusion is not supported and appears to be a leap of faith rather than a serious attempt to use the evidence to derive a lower bound for the confidence interval of any possible effect.

Finally, I have to say that if one of my students handed in a paper which did an epidemiologic analysis of a potential causal relationship and concluded in the paper that it was impossible to even make a guess as to the point estimate of the purported effect, I would hope that the student would not conclude the paper by stating: "While we have no idea what the point estimate is or the variability around that point estimate, I conclude nevertheless that the confidence interval must not cross zero." I suspect I would give the student a failing grade on the paper.

Just to be clear, I would love to be able to take a leap of faith and conclude that all of my efforts over the past 24 years have resulted in policies that produced dramatic declines in heart attacks within one to two years. But as scientists, our role is not to take leaps of faith. It is to consider the empirical evidence and base our conclusions on that scientific evidence.

It is not the IOM committee's fault that the underlying studies are frought with severe weaknesses, that only a few of them employed comparison groups, and that the existing evidence is simply not sufficient to even guess as to the point estimate for a purported effect. But you aren't required to draw a causal conclusion from weak data. You could also come out and say: "The evidence is suggestive of an effect, but we simply don't have enough evidence to draw a definitive causal conclusion at this point. We just can't rule out the possibility that random variation in heart attacks, especially in small communities, and the existing secular trend of decreasing heart attacks due to substantial advances in medical treatment for heart disease during the time period of these studies are a plausible alternative explanation for the observed declines in heart attack rates in these studies."

Instead, it appears that the report felt it necessary to draw a definitive causal conclusion, even in the absence of what is essentially its own admission that there is insufficient evidence to draw such a conclusion.

IOM Proceedings Introduced Bias into Report: Only One Side of Smoking Ban Studies Was Presented in Committee's Public Meetings

Today, I reveal that another element of bias in the Institute of Medicine's report on the effect of smoking bans and heart attacks occurred in the proceedings that the Committee undertook in reviewing the relevant data.

The Committee held a public meeting in which it heard presentations by experts in the field covering various topics. According to the report, the topic of smoking bans was only presented by one expert: Dr. Stan Glantz.

The Rest of the Story

Dr. Glantz has a very particular view of the smoking ban studies. I have no problem with the Committee choosing to ask him to present his side of the issue. However, to achieve balance and entertain alternative hypotheses, the Committee should also have invited someone to present the other side of the issue.

If you only hear one side of the issue, then of course you are going to get a biased picture of the data out there. This could easily result in bias in the Committee's analysis and report.

It doesn't appear to me that there was a serious effort to elicit both sides of this scientific question because the Committee was only presented with one side of the picture. How could that not result in a biased analysis?

I hate to use the term, but it appears that the deck was stacked. None of the experts asked to address and provide background materials to the Committee had taken the position that the scientific evidence is not sufficient to conclude that smoking bans result in dramatic, immediate reductions in heart attacks. Thus, it is perhaps not surprising that the Committee failed to consider the multitude of data that refutes its ultimate conclusion.

For example, had I been asked to address the Committee, they would have had in hand all the relevant data from England, Scotland, Denmark, and Wales which showed no effect of the smoking bans in those countries on admissions for acute coronary events. At least they would have had the data in hand and could have considered it as part of its review. These data could also have been provided by any number of other experts in the field. But if you only review data that support a conclusion, you're going to end up drawing that conclusion, regardless of its validity.

The rest of the story is that not only is the report of the IOM committee on smoking bans and heart attacks biased, but the process that led to this report appears to be significantly biased as well.

Data from Denmark Show No Apparent Effect of Smoking Ban on Heart Attacks

Data from a government study of the effects of the smoking ban in Denmark show no apparent impact of that smoking ban on heart attack hospital admission rates.

The study analyzed rates of hospitalization for heart attacks in all hospitals in Denmark for a period of five years prior to the smoking ban (implemented in August 2007) and 18 months after implementation of the ban. A statistical model controlled for age, month, and secular trends in heart attack rates. No effect of the smoking ban was detected for either 35-64 year-old males, 35-64 year-old females, 65-84 year-old males, or 65-84 year-old females.

The trends in heart attacks among one of these four groups - men ages 35-64 -- is shown in Figure 6 of the report. As can be seen, there is a clear trend of decreasing heart attack rates over time. Seasonal variation in heart attacks is also clear. There is no apparent effect of the smoking ban on the trend in heart attacks. According to the report, the graphs for each of the other three demographic groups are similar, with no apparent effect of the smoking ban on heart attacks in any of the four study groups.

An advantage of this study is that Denmark has an excellent national registry of heart attack admissions. In addition, the report notes that there were few changes in treatment of heart disease in the country during the period surrounding the implementation of the smoking ban.

The Rest of the Story

This is now the fourth country for which data show no short-term effect of the smoking ban on admissions for acute coronary events. The others are England, Scotland, and Wales. None of these findings were included in the Institute of Medicine report which concluded that smoking bans cause an immediate and substantial decline in heart attacks.

An important observation is that the few studies which found large effects of the smoking bans were in very small communities. None of the studies that covered larger populations -- states or countries -- found large effects and many of these studies found no effect. This suggests that the findings from isolated communities - like Helena and Pueblo - are merely random phenomena. The fact that these results cannot be confirmed in any population-based study is concerning.

This pattern of findings also confirms that there is a severe publication bias present. We now have data from four countries showing no short-term effects of the smoking ban on acute cardiovascular events, yet none of these studies have been published. Researchers have a hard time getting excited about negative results and so they are much less likely to decide to publish such data. In contrast, when they find an effect, they are excited about publishing the findings. This is clearly what is going on with these smoking ban and heart attack studies.


(Thanks to Klaus K. for kindly providing the English translation of this report).

Analysis Reveals that Institute of Medicine Report Failed to Include Data that Found No Effect of Smoking Bans on Acute Coronary Events in 3 Countries

Bias in Report Results from Failure to Consider Data Which is Inconsistent with Report's Conclusions

I have analyzed the data which the Institute of Medicine included and failed to include in its report and today, I reveal that the report failed to consider data from three countries (England, Scotland, and Wales) which seem to clearly show that the smoking bans in these countries had no significant short-term effect on acute coronary events. These data are all national data which include all hospital admissions at all hospitals in these countries. Thus, they represent a better source of data than what was used in some of the published studies (which only included a sample of hospitals). Moreover, they cover large populations, with a sample size greater than that of all other studies combined. Thus, the data from these countries are critically important an carries much weight in the overall analysis.

ENGLAND

National data from the National Health Service show that England's smoking ban had no effect on the trend in the number of heart attack admissions during the first nine months that the ban was in effect.

The National Health Service has reported annual summaries of the total number of emergency room admissions for heart attacks or for admissions in which the patient subsequently suffered a heart attack. These data cover all hospitals in England; thus, there are no gaps in the data. The data cover the fiscal year, starting April 1 of the first calendar year and ending March 30 of the second calendar year. Thus, the 2007-2008 data cover the period from April 1, 2007 through March 30, 2008.

The smoking ban in England took effect on July 1, 2007. Thus, although the 2007-2008 data contain figures for three months during which the ban was not yet in effect (April, May, and June), if the ban had any dramatic effect on heart attacks (such as a 27% which is the figure which anti-smoking researchers are citing), one would expect to see some significant acceleration of the existing secular decline in heart attack admissions during the reported 2007-2008 period.

However, there was only a 2% decline in heart attack admissions in England from 2006-07 to 2007-08, compared to a 2.8% decline in the preceding year and a 3.8% decline in the year preceding that. Thus, these data show no evidence that the smoking ban resulted in any significant, immediate decline in heart attacks.

Also, these data are very important, because the sample size is huge. Unlike the small sample sizes in studies from Helena, Pueblo, and Bowling Green, the sample size in this England study is larger than all of the published studies combined. In addition, the study covers a long period of time, not just the year before and after the smoking ban (as is the case with some of the published studies).

The data above include all hospital discharges with a diagnosis of heart attack, both those in which the heart attack was the presenting reason for admission and those cases in which the patient suffered a heart attack subsequent to admission. While there is nothing wrong with this, someone could argue that it is only the admissions for a presenting heart attack that are relevant, because presumably, subsequent heart attacks experienced in the hospital are not triggered by secondhand smoke exposure.

I re-ran the analysis using only hospital admissions for presenting heart attacks (those which presumably might have been triggered by secondhand smoke, as hypothesized by many tobacco control researchers). The data look like this:



As one can see visually, there is absolutely no change in the trend of declining heart attack admissions in England during the first nine months during which the ban was in effect. There appears to be a relatively steady decline in heart attack admissions from 2002-2008, with no change associated with the smoking ban.

The decline in heart attack admissions from 2006-2007 to 2007-2008 was 3.7%, compared to declines of 3.7% in the preceding year and 3.8% in the year before that.

Thus, this analysis confirms that no matter how you look at it, there was no change in the rate of declines in heart attack admissions in England associated with the first nine months of the smoking ban.

SCOTLAND

Data from the Scottish national health service, which cover all of Scotland, reveal that while there was a decline in acute coronary event admissions (heart attacks plus angina) in the first year after the smoking ban, the admission rate increased during the second year back to baseline levels. Thus, there does not appear to be any evidence that the smoking ban in Scotland, implemented in April 2006, led to a decrease in coronary event admissions.



WALES

National data from Wales reveal that there was no reduction in hospital admissions for myocardial infarction (heart attacks) during the first 9 months after implementation of the smoking ban throughout Wales. Monthly data on heart attack admissions from all Welsh hospitals for the years 2006 and 2007 were examined. The smoking ban went into effect on April 2, 2007.

There were 4,199 heart attack admissions in 2006 and 4,155 in 2007. Thus, there was essentially no change in heart attacks between these two years. In contrast, there was a 6.3% decline in heart attack admissions from 2005 to 2006 and a 10.3% decline in admissions from 2004 to 2005.

When analyzing the data by month and comparing 2007 to 2006, there was an increase in heart attack admissions during the first five months after the smoking ban (April through August) and a decline in heart attack admissions during the next four months (September through December).

It seems quite clear that the data show that the smoking ban in Wales was not associated with a decline in heart attack admissions during the first 9 months it was in effect (and if anything, the decline in heart attacks came to a halt).

The Rest of the Story

The reasons why the report failed to consider these national data are not clear. However, what is clear is that these data were not presented and reviewed in the report.

For this reason, I believe that the conclusions of the report are severely biased. You cannot possibly come to an unbiased conclusion about the effects of smoking bans on heart attacks if you only consider data which support the contention that these bans are having a strong effect. Obviously, if you exclude data which are counter to your conclusion, you are going to bias your analysis.

It appears this is exactly what happened here.

Remember that a meta-analysis or review of data is only as good as its success in reviewing all relevant data that are available. If you only include data that support your position, you are going to end up with a biased conclusion.

By the way, the data for England and Scotland are readily available online and I believe that the committee was made aware of the existence of these data.

The rest of the story is that the report is biased because it fails to include very relevant data from England, Scotland, and Wales which show no evidence that the smoking bans in those countries caused significant short-term reductions in acute coronary event hospital admissions. Because of the size of the populations covered by these data, including them in the overall review would have negated the overall conclusion of the report.

New York Times Article About Institute of Medicine Report

The link is here. I am quoted as pointing out that the report concludes that anyone exposed briefly to secondhand smoke could suffer a heart attack, while the truth is that this risk only is significant for people with severe pre-existing heart disease. I also challenge the validity of the report's conclusion on the effect of smoking bans, given that the report itself argues that it has no confidence in even estimating the magnitude of effect (and also that the individual studies were severely flawed and the committee failed to review data which showed no effect of smoking bans on heart attacks in three different countries).

New York ABC News Story on Institute of Medicine Report

Here is a link to the New York ABC News story on the Institute of Medicine report on smoking bans and heart attacks. After clicking on the link, you need to click on "VIDEO: Impact of Smoking Bans." The story includes a brief comment from me regarding the lack of sufficient evidence to conclude that the observed declines in heart attacks in the studies reviewed by the committee are attributable to the smoking bans.

Remember, however, that the committee only reviewed studies which found evidence to support its conclusion. The committee apparently did not review any of the data which showed that there was no effect of smoking bans, including data from England, Scotland, and Wales. A major reason why I view the report as being biased is specifically because of its failure to consider all of the data. If you only consider data in support of a given conclusion, you are going to end up with a systematically biased review.

Institute of Medicine Report's Conclusions on Smoking Ban Effects are Defied By Its Own Assertions; Study Conclusions, Press Release Severely Biased

A new report from the Institute of Medicine's Committee on Secondhand Smoke Exposure and Acute Coronary Events, entitled "Secondhand Smoke and Cardiovascular Effects: Making Sense of the Evidence," concludes that smoking bans result in a nearly immediate and significant decrease in heart attacks, not only among smokers but among nonsmokers as well. The committee also concluded that brief exposure to secondhand smoke causes heart attacks and refused to qualify its conclusion by noting that such an effect is substantial only in those with severe existing heart disease.

According to the press release: "Smoking bans are effective at reducing the risk of heart attacks and heart disease associated with exposure to secondhand smoke, says a new report from the Institute of Medicine. ... 'It's clear that smoking bans work,' said Lynn Goldman, professor of environmental health sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, and chair of the committee of experts that wrote the report. 'Bans reduce the risks of heart attack in nonsmokers as well as smokers.'"

The Rest of the Story

Unfortunately, this report might just as well have been called: "Secondhand Smoke and Cardiovascular Effects: Making Nonsense of the Evidence."

The reason for this assertion is two-fold:

First, the conclusions of the report are completely defied by the committee's own assertions that are presented in the actual report.

Second, the report draws conclusions that are essentially meaningless from an epidemiologic and clinical perspective. What the report does is take important questions and distort them so much that the answers no longer have any meaning.

Let me address each of these problems in turn.

To see what I mean about the conclusions of the report not being consistent with the report itself, consider first what the report concludes about the ability, based on the existing evidence, to estimate the magnitude of the effect of smoking bans on heart attack rates.

The report asserts as follows: "The committee was unable to determine the magnitude of effect on the basis of the 11 studies, because of variability among and uncertainties within them. Characteristics of smoking bans vary greatly among the locations studied and must be taken into account in reviewing results of epidemiologic studies. Those characteristics include the venues covered by the bans (such as offices, other workplaces, restaurants, and bars) and compliance with and enforcement of the bans. Other differences or potential differences among the studies include the length of followup after implementation, population characteristics (such as underlying rates of acute coronary events and prevalence of other risk factors for acute coronary events, including diabetes and obesity) and size, secondhand-smoke exposure levels before and after implementation, preexisting smoking bans or restrictions, smoking rates, and method of statistical analysis. The time between implementation of a ban and decreases in secondhand smoke and acute cardiovascular events cannot be determined from the studies, because of the variability among the studies and indeed the difficulty of determining the precise time of onset of a ban."

The report also asserts: "However, because of the weaknesses discussed above and the variability among the studies, the committee has little confidence in the magnitude of the effects and, therefore, thought it inappropriate to attempt to estimate an effect size from such disparate designs and measures."

In other words, what the committee is saying is they have no confidence in making any estimate of the size of an effect of smoking bans on heart attack rates. Another way to say that is this: the committee has no idea of what the effect of smoking bans on heart attacks is.

If you can't even estimate the magnitude of an effect - if you have no confidence in even providing an estimate - then you are hardly in a position to conclude that there is a significant effect of smoking bans on heart attacks, an effect which exceeds random variation combined with the known secular decline in heart attack rates.

Think about this: we know for a fact that heart attack rates are declining substantially, even in the absence of smoking bans. These declines are in part attributable to improvements in the treatment of coronary disease and also to improved medications, such as the statin drugs which are effective in controlling cholesterol levels. When we see a decline in heart attacks after a smoking ban, we need to determine whether the magnitude of that decline is greater than one would expect in the absence of the smoking ban. In other words, does the observed decline exceed the rate of decline one would expect from the secular changes alone?

In order to make such a determination, one needs to quantify the magnitude of the decline in heart attacks. If we can't even estimate, with any confidence, what the magnitude of the decline in heart attacks is, then we are in no position to conclude that we know that the decline is greater than what would have been observed in the absence of the smoking ban. We can't conclude that the observed decline in heart attacks associated with smoking bans has been due to the smoking ban, rather than to the rather drastic declines in heart attacks that have been occurring anyway due to improvements in medical treatment.

Epidemiology is all about estimating the magnitude of effects. Simply judging whether an association works in one direction or the other is not particularly meaningful, especially in this situation where we know a priori that smoking bans do not increase heart attacks.

Now this is where my 2nd observation comes in. By answering the question: do smoking bans reduce or increase heart attacks, the report is actually making nonsense out of the evidence. Of course smoking bans don't increase heart attacks. The question is: what is the magnitude of the effect.

The committee recognizes that the existing studies are so seriously flawed that one has no confidence in being able to judge the effect size. But instead of concluding that the evidence is insufficient, they go ahead and conclude that smoking bans significantly reduce heart attacks anyway.

A second example is the press release's conclusion about whether the observed reductions in heart attacks occur in smokers or nonsmokers. The report asserts: "Only two of the studies distinguished between reductions in heart attacks suffered by smokers versus nonsmokers." Later, it emphasizes this point: "In most of the studies, the portion of the effect attributable to decreased smoking by smokers as opposed to decreased exposure of nonsmokers to secondhand smoke cannot be determined."

Clearly, this is not sufficient evidence to draw a conclusion about whether the observed reductions in heart attacks are due to reduced active smoking or reduced tobacco smoke exposure among nonsmokers.

Nevertheless, the press release states: "Bans reduce the risks of heart attack in nonsmokers as well as smokers."

So much for requiring evidence before drawing a conclusion.

Perhaps the problems I am discussing are most evident in the report's conclusion regarding the effects of brief secondhand smoke exposure on heart attack risk. Based on the evidence, no one would deny that a brief exposure might trigger a heart attack in a person with severe existing coronary artery disease.

But the report goes beyond that in its conclusion. It states that brief secondhand smoke exposure may trigger heart attacks, but without qualifying that statement to make it clear that it refers specifically to people who have coronary disease. Instead, it makes it sound like a healthy person could walk into a smoky bar, sit down for 20 minutes, and keel over from a heart attack.

Why is this qualification not added to the study conclusion?

I believe it's because the report aims to be more sensationalistic and scare people into thinking that they could drop dead from a heart attack from a brief tobacco smoke exposure, even if they are healthy.

But failing to qualify the statement turns the conclusion from being accurate to being inaccurate, from being truthful to being misleading.

What it really means is that a political goal, not a purely scientific one, is driving the report's conclusion regarding the acute cardiovascular effects of tobacco smoke exposure. I find this unfortunate because it really taints the scientific integrity of the tobacco control movement.

I should probably add that if you read the report carefully, it actually makes the assertion that brief secondhand smoke exposure can appreciably increase the risk of heart attack among healthy people. The report states: "The data provide evidence that it is biologically plausible for secondhand smoke to be a potential causative trigger of acute coronary events. The risk of acute coronary events is likely to be increased if a person has preexisting heart disease."

I read this as asserting that brief secondhand smoke exposure triggers heart attacks among people with and without existing heart disease, but that the risk is higher for those with existing heart disease. I do not believe there is any evidence to suggest that such an assertion is true. The report provided no evidence that a healthy person may suffer a heart attack from a mere 20 to 30 minutes of secondhand smoke exposure.

There is one other major problem with the report that deserves mention, especially since I think it indicates a bias of the report.

The report claims to have reviewed unpublished data and to have attempted to identify unpublished studies that might have found no effect of smoking bans on heart attacks. The report states that "no such studies were identified." I find this difficult to believe, especially since I was a reviewer of the report and I made the committee aware of several unpublished analyses which documented no significant effect of smoking bans on heart attacks. Such studies were conducted in England, Scotland, and Wales. Furthermore, a large but unpublished study of all communities in the United States reported no effect of smoking bans on heart attacks, but this study was ignored by the report.

Note that the latter study, the largest of its kind, concluded that: "In contrast with smaller regional studies, we find that workplace bans are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction or other diseases."

It is unfortunate that this study was ignored. I don't see how the review can be considered to be comprehensive if it threw out or ignored all the studies that failed to find an effect, but included, without question, all studies that found an effect, even if these studies failed to include a comparison group which is crucial to being able to infer whether the observed decline in heart attacks was attributable to the smoking ban.

Finally, I want to make it very clear that I am not impugning the integrity of the committee or any of its members. I don't think they've done anything wrong. I just think that the report is biased and that subconsciously, there was some sort of pressure operating which led to the report drawing conclusions that were not appropriate given the report's own assertions and review of the evidence. I also think this bias led to the report distorting the questions which it asked and failing to directly answer the questions (rather than distorting them so that the "answer" came out more "favorably").

Action on Smoking and Health (UK) Supports Electronic Cigarettes

Action on Smoking and Health - UK (ASH-UK) has become one of the first anti-smoking organizations to support the continued presence of electronic cigarettes on the market. Unlike its U.S. counterpart (ASH-US), which has called for a ban on electronic cigarettes and has gone so far as to threaten electronic cigarette sellers with the prospect of jail sentences, ASH-UK released a statement indicating its support for the use of electronic cigarettes by smokers who are otherwise unable to quit smoking.

According to the statement: "ASH supports a harm reduction approach to tobacco, that is, we recognise that whilst efforts to help people stop smoking should remain a priority, many people either do not wish to stop smoking or find it very hard to do so. For this group, we believe that products should be made available that deliver nicotine in a safe way, without the harmful components found in tobacco. Most of the diseases associated with smoking are caused by inhaling smoke which contains thousands of toxic chemicals. By contrast, nicotine is relatively safe. Therefore, e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco
smoke, are likely to be a safer alternative to smoking. In addition, e-cigarettes reduce secondhand smoke exposure since they do not produce smoke."

Thus, while ASH-UK believes that regulation of e-cigarettes is reasonable, the group does not join ASH-US in condemning the product and calling for its immediate removal from the market.

Christopher Snowdon has more on ASH UK's position on this issue.

The Rest of the Story

This is wonderful news, as it represents one of the first major anti-smoking groups which has come out in support of allowing electronic cigarettes to remain on the market. Unfortunately, our counterparts in the UK appear to have a much more rational attitude than we do in the States regarding whether or not we would prefer to see people die or not.

Here, the major anti-smoking groups have expressed their support for a policy (banning e-cigarettes) which would result in disease and death for thousands of people, as ex-smokers would be forced to return to cigarette smoking. I'm gratified to see that ASH-UK has the good sense to support a policy which would save lives, rather than cause illness and death.

In Anti-Smoking Advocates' View, Opposing Tobacco Control Dogma Means You Must Be a Paid Industry Hack

A close colleague of mine has insinuated to others that my opinions against the prohibition of electronic cigarettes may be motivated by payoffs I am receiving from electronic cigarette companies.

The colleague has raised this question to other close colleagues of mine, but importantly, provided absolutely no evidence that I am being funded by electronic cigarette companies.

The Rest of the Story

This is an important story, not because of the actual implications for me on a personal level, but because it demonstrates an aspect of the anti-smoking movement's mentality. In the tobacco control movement's view, it is apparently not possible for someone to hold the opinion that electronic cigarettes could be a safer alternative to cigarette smoking and could therefore be saving lives. The mere fact that someone expresses such an opinion immediately raises the specter that the individual is being paid off by electronic cigarette companies.

It also demonstrates that many anti-smoking advocates are willing to make personal attacks, accusations, and insinuations -- even against their own colleagues -- without any evidence whatsoever to support these insinuations. The colleague in question has provided not a shred of evidence of my funding by electronic cigarette companies. He has provided no documentation that I have received payments from the electronic cigarette industry and that these payments have influenced my opinions about the issue of the relative safety of vaping versus smoking.

This adds to a long and ugly history of unfounded accusations that anti-smoking groups and advocates have made about those who disagree with the dogma of the movement. What is odd here, and perhaps surprising, is that these accusations are being made not against an opponent, but against a tobacco control advocate himself.

If you oppose any aspect of the dogma of the movement, you in essence become an enemy, even if you are actually a vehement anti-smoking advocate and a close colleague.

This is truly fascinating to me.

The Rest of the Story Called Watchdog of the Tobacco Control Movement

An interesting article in Youth Today refers to The Rest of the Story as the "watchdog" of the tobacco control movement.

The article reviews the financial records of the American Legacy Foundation and some aspects of the Foundation's actions and laments that there has been little oversight of the Foundation's actions. However, it notes that this blog has served as a sort of watchdog for the anti-tobacco movement, pointing out a number of hypocritical actions that the Foundation has taken.

According to the article's section entitled "A Blogger Watchdog":

"One of the few people who pay close attention to the foundation’s financial operations is Michael Siegel, a professor at the School of Public Health of Boston University. Siegel takes issue with the foundation’s unwavering decision not to give grants to anyone or any public health school that receives tobacco money."

"On his blog – “The Rest of the Story: Tobacco News Analysis and Commentary,” at http://www.tobaccoanalysis.blogspot.com – Siegel has taken the foundation to task for partnering with the likes of Time Warner, Conde Nast and Hearst, all of which rely heavily on tobacco advertising and “constantly bombard youth” with tobacco ads, and for funding research to bolster its claims of success against smoking."

"Siegel doesn’t have any complaint with most of the research the foundation underwrites, but thinks it is “hypocritical not to give money to institutions that are actively seeking money for tobacco programs” on the grounds that they receive tobacco money, considering the fact that the source of the foundation’s money is the settlement from the tobacco companies."

"In one of his postings, Siegel upbraided the foundation for allegedly funding a “front group,” Citizens’ Commission to Protect the Truth, to lobby in a lawsuit for more money for American Legacy’s truth campaign."

The Rest of the Story

Ironically, I think that in many ways, The Rest of the Story does serve as sort of a watchdog of the tobacco control movement, playing a role that the tobacco industry deliberately relinquished some time around 2000.

It was The Rest of the Story that highlighted the American Legacy Foundation's corporate partnerships with Time Warner, Hearst, and Conde Naste Publications -- all of which are responsible for massive youth exposure to tobacco advertising -- at the same time as the Foundation lamented the problem of youth exposure to tobacco advertising in magazines and in movies.

It was The Rest of the Story that revealed the American Legacy Foundation's funding of a front group -- The Citizen's Commission to Protect the Truth -- to support increased funding for the Foundation under the ruse that this was some sort of group of concerned citizens.

I should clarify that I did not criticize Legacy for deciding not to give money to organizations that accept tobacco money. I criticized Legacy for the hypocritical action of not giving money to anyone else who takes tobacco money, while at the same time pleading with the tobacco companies to give them more money to run Legacy's campaigns.

It is the American Legacy Foundation's hypocrisy over the past few years that The Rest of the Story has brought to the forefront.

To be clear, I believe that the "truth" campaign has been effective in reducing youth smoking and I have in fact supported the idea of establishing similar campaigns in all 50 states as well as enhancing funding for the national campaign. In fact, I have argued that wasting all our time and resources on FDA regulation of tobacco has detracted attention from where it really needs to be: finding a way to fund real, state-of-the-art, anti-tobacco media campaigns in all 50 states.

But that doesn't mean that the means used to achieve the end of preventing youth smoking should not be subject to scrutiny.

The comments section of the Youth Today article gives a brief but interesting insight into the mind of the anti-smoking activist. In these comments, Dr. Michael Cummings of the Roswell Park Cancer Institute calls me a "naysayer" for having the nerve to criticize as what I see as inconsistent, hypocritical, or unethical actions by the Foundation. What he is basically saying is that any criticism of anti-smoking groups is unwarranted and makes you a "naysayer." You must have blind allegiance to the ideology of the movement and if you dare to swerve off the prescribed path, you are a heretic who must be attacked and silenced.

California Governor Vetoes Bill Banning Electronic Cigarettes

California Governor Arnold Schwarzenegger announced yesterday that he was vetoing California Senate Bill 400, which would have banned the sale of electronic cigarettes in California. In his veto message, Schwarzenegger indicated that he would have supported legislation that restricted the sale of electronic cigarettes to minors, but that he does not support an outright ban on the sale of electronic cigarettes in the state.

It does not appear that the bill has enough support in the Senate to override this veto, so it is unlikely that the sale of electronic cigarettes will be banned in California.

The Rest of the Story

This is a great victory for the public's health, as it ensures that ex-smokers who have quit successfully using electronic cigarettes will be able to stay off cigarettes rather than being forced to return to cigarette smoking, which is far more dangerous than vaping.

It is also a blow to anti-smoking groups' efforts to ban the sale of electronic cigarettes.

Of course, it is a great irony that the defeat of a policy for which anti-smoking groups are pushing represents a victory for the public's health. One would have thought that these groups would have the best interests of the public's health in mind.

Anti-Smoking Researcher Claims that Smoking Bans Reduce Heart Attacks Within Minutes of Implementation

We're all familiar with the claims by some anti-smoking advocates that smoking bans reduce heart attacks relatively quickly after implementation, such as over a period of six months or one year.

But now, an anti-smoking researcher has claimed that these bans reduce heart attacks within just minutes of implementation.

According to an article in the Lawrence Journal-World & News, Dr. David Meyers, professor of cardiology and preventive medicine at Kansas University Medical Center and lead investigator of a new study on smoking bans and heart attacks, claimed that: "Within minutes of the ban, it is going to start having an effect on heart attacks."

Meyers was quoted as supporting his claim with the following argument: "Heart attacks are caused in large part by blood clots. With 20 minutes or so of tobacco smoke exposure, people’s blood becomes hypercoagulable and sticky and clots easily, and bam, you have a heart attack."

The study being reported is a meta-analysis of 11 previously published studies that examined the effect of smoking bans on heart attack rates in specific communities (such as Helena, Pueblo, and Bowling Green) or in countries with national smoking bans (such as England, Italy, and Scotland). The meta-analysis found that: "Using 11 reports from 10 study locations, AMI risk decreased by 17% overall (IRR: 0.83, 95% CI: 0.75 to 0.92), with the greatest effect among younger individuals and nonsmokers." The study concluded: "Smoking bans in public places and workplaces are significantly associated with a reduction in AMI incidence, particularly if enforced over several years."

The Rest of the Story

What readers need to understand is that a meta-analysis is only as good as the individual studies that go into it. If the individual study conclusions are invalid, then the meta-analysis will be invalid as well. This is exactly the case with the present study.

I have previously analyzed each of the published studies on smoking bans and heart attacks and explained why the conclusions of these studies are invalid. You can't just combine the studies in a meta-analysis and argue that suddenly the conclusion becomes valid. The meta-analysis does not account for the severe flaws in these studies, including the failure to adequately rule out the possibility that the observed declines in heart attacks merely reflected a combination of random variation plus an already declining secular trend in heart attacks over time.

But the most telling fact about this meta-analysis is that it fails to incorporate any control or comparison population. In other words, it includes studies even if they did not employ a comparison group. And in the studies that did include a comparison group, it appears to throw out the data regarding the comparison group.

What this means is that the meta-analysis is not designed to estimate the effect of smoking bans on heart attacks. What it is designed to do is to determine the change in the incidence of heart attacks over the time period in these studies. What the meta-analysis demonstrates is that across all study populations, there was a significant decline in heart attack rates.

But we already knew that. For many reasons, including better treatment for heart disease (both surgical treatment and medications), heart attack rates have generally been declining, even in the absence of smoking bans. The relevant question for the meta-analysis should have been: are these observed declines due to the smoking ban? Instead, the meta-analysis simply asked the question of whether there was or was not a decline in the first place? This is useful information, as it confirms our a priori impression that rates have been declining, but it offers no evidence that the declines are due to smoking bans, as opposed to other changes, such as improved diagnosis of minor coronary events, earlier diagnosis of unstable angina, improved surgical treatment (angioplasty) for coronary artery disease, and greatly improved medical treatment (e.g., statins to bring cholesterol levels under control).

In essence, what we have here is a meta-analysis of studies without comparison groups!

I don't see how you can possibly include in this meta-analysis studies that failed to include a comparison group. There's simply no way to know whether the observed decline in heart attacks was attributable to the smoking ban or not.

In short, the meta-analysis presents the wrong analysis. It should not present the estimated change in heart attack rates before and after the smoking bans. We know that the rate is going to go down significantly because of the known secular trends in heart attacks, which are declining everywhere, even in the absence of smoking bans.

Instead, the correct analysis would have been to examine the individual estimates of the difference between the declines in heart attack rates in intervention (i.e., smoking ban) versus comparison communities or countries.

As my readers know, I strongly support workplace smoking bans. Nevertheless, I believe they should be supported based on valid scientific conclusions, not on junk science conclusions such as those in this article.

Another telling finding in the meta-analysis is that the studies which found the large declines in heart attacks (and which drive the findings of the whole meta-analysis) were the studies of the smallest communities, where there is the greatest variation in heart attack rates. The larger studies, with very large populations, failed to find substantial effects.

This suggests that the conclusions are due primarily to a few anomalous findings in small communities with very few heart attacks. When one examines the results among a large population, one fails to find the reputed effects.

The meta-analysis itself reports that there was no effect of the smoking ban in either the state of New York (the largest population studied) or the country of Italy (the second largest population studied). The results appear to be entirely driven by the findings in Helena, Monroe County, and Pueblo, which include two of the smallest populations studied (there were only 17 heart attacks in Monroe County to begin with and only about 40 in Pueblo during the post-ban period).

The most interesting aspect of this story, however, is that even if we stipulate for the sake of argument that the study conclusions are correct, what the results would show is that over a period of time -- months to years -- there is a decline in heart attacks. The study does not support the assertion that there is a decline in heart attacks within minutes of a smoking ban.

I have to take issue with the explanation for this immediate effect. As put by one of the study authors: "Heart attacks are caused in large part by blood clots. With 20 minutes or so of tobacco smoke exposure, people’s blood becomes hypercoagulable and sticky and clots easily, and bam, you have a heart attack."

If this statement were true, then we would see large numbers of previously healthy people dropping dead of heart attacks in smoky bars after 20 minutes. If it is true that your blood clots easily and bam you have a heart attack, then many healthy people going into a smoky bar would leave the bar after 20 minutes in an ambulance. We just don't see that happening (except, perhaps, for those who severely overindulge to the point of alcohol intoxication -- mostly college freshmen).

The truth is that brief secondhand smoke exposure is likely to trigger a heart attack only in people with severe existing coronary artery disease. And for such individuals, there are so fragile that any exposure which increases platelet aggregation and causes endothelial dysfunction -- is also likely to trigger a heart attack. There is no mechanism I know of by which secondhand smoke is the only exposure that can trigger a heart attack in some who is brittle enough so that a mere 20 minute exposure to tobacco smoke is going to trigger a heart attack. The same hypercoagulability and endothelial dysfunction is also caused by eating high-fat foods and even by mental stress. It doesn't follow that you are going to prevent this person from having a heart attack merely by asking them to avoid exposure to secondhand smoke. Moreover, there is simply no scientific evidence to support the assertion that by avoiding secondhand smoke exposure, we will prevent heart attacks among individuals with severe coronary artery disease.

The rest of the story is that anti-tobacco researchers and groups are making ridiculous, highly exaggerated, and scientifically unsupported claims in order to try to justify smoking bans. While I support the very smoking bans which these groups are promoting, I do not support the junky science and wildly exaggerated and misleading claims that are being made to the public.

Yet Another Supposed Public Health Victory from the FDA Tobacco Law Goes Down the Tubes: Ban on "Light" Cigarettes Will Have No Effect

According to the Campaign for Tobacco-Free Kids, two of the major public health victories from the passage of the FDA tobacco legislation -- which were supposed to save "countless lives" -- were the ban on flavored cigarettes and the ban on the use of descriptors like "light" and "low-tar" that mislead consumers into believing that these cigarettes are safer.

But one by one, these (false) promises have come tumbling to the ground.

First, it was the promise that the ban on flavored cigarettes would break the cycle of addiction by helping to end the tobacco industry's ability to addict our nation's children. The Campaign wrote that: "The ban on candy and fruit-flavored cigarettes is a critical step to end one of the most insidious tactics the tobacco industry has used to target and addict children."

But the truth came out: not a single product produced by Philip Morris, R.J. Reynolds, or Lorillard was affected by the cigarette flavoring ban, very few youths smoke products that are affected by the ban, and in the entire cigarette market, less than 0.2% of all cigarettes consumed are flavored cigarettes covered by the ban. The truth is that far from being a critical step to halt addiction, this aspect of the law does literally nothing to protect kids from addiction.

Now, it is the promise that the ban on descriptors such as "light" and "low-tar" will eliminate the deception of consumers, who are led to believe that these products are safer because of this terminology.

In its propaganda supporting the Family Smoking Prevention and Tobacco Control Act, the Campaign suggested that this legislation would "end the tobacco industry's deceptive marketing of "light" and "low-tar" cigarettes."

However, according to new information released today by the Boston Globe, the ban on "light" and "low-tar" descriptors will have no effect because cigarette companies have developed a way to use colors in cigarette packaging to convey the same information that was previously conveyed through this terminology.

According to the article: "The cigarettes in the royal blue package aren’t Pall Mall Lights anymore. Now, they’re called Pall Mall Blues. Salem Lights, once sheathed in a kelly green box, are now cloaked in pastels and white, and known as Salem Gold Box. With the new branding, and use of hues shown to evoke feelings of smoothness and health, a leading tobacco company has revealed a subtle sales strategy for an era of unprecedented federal oversight: Let the colors speak to smokers in the same way the soon-to-be-banned words “mild,’’ “light,’’ and “ultralight’’ did. Harvard researchers and other tobacco control specialists see in the new monikers and lighter, brighter palettes evidence that cigarette producers are intent on subverting a new law that empowers the US Food and Drug Administration to regulate tobacco companies - including a provision that as of next June 22 will banish words that promote certain cigarettes as safer. Tobacco control specialists have long harbored particular contempt for “mild’’ and “light’’ cigarettes, arguing they manipulate smokers into thinking those brands are less harmful when there’s no scientific evidence to support that claim."

"R.J. Reynolds Tobacco Company, maker of the Pall Mall and Salem brands, denies attempting to bypass the law and says it is merely seeking to guide customers to their favorite brands. But researchers said they recognize the packaging changes as a tactic the industry has rolled out in other countries with stringent tobacco rules. Studies conducted in Canada and the United Kingdom, which both have a longer history of restricting tobacco industry marketing, found that smokers believe products labeled as “silver,’’ “gold,’’ or “smooth’’ are safer and easier to stop using than high-octane cigarettes. “These tricks are now well-established,’’ said Stanton Glantz, a tobacco control specialist at the University of California, San Francisco." ...

"Reynolds, the nation’s second-biggest cigarette company, makes no secret of its reason for altering the packaging. Company spokesman David Howard cited both the impending federal regulation and a federal court ruling - currently on hold - that would also expunge the mild and light names. “By using designations such as colors,’’ Howard said, “that makes it possible for retailers and adult tobacco consumers to clearly identify the different styles moving forward.’’ The manufacturer used focus groups and other research to arrive at the new package designs, already evident on four company brands and coming soon to three of its best-known products, Camel, Doral, and Winston. Harvard School of Public Health researcher Greg Connolly, former director of Massachusetts’ tobacco control program, said he noticed the changes on a stop at a West Virginia convenience store a few weeks back. Connolly decided to see what would happen when he asked the clerk for a pack of Salem Ultra Lights.“He gave me a pack of Salem Silvers, and I said, ‘No, no, no, where are the lights?’ ’’ Connolly recalled. “And he said, ‘These are lights, these are the same thing. All they’ve done is change the name because of the new federal requirement."

The Rest of the Story

This would all really not be so bad if it weren't for the fact that we (me and a small number of other tobacco control advocates who opposed the FDA tobacco legislation) predicted that exactly this scenario would unfold: the cigarette flavoring ban would have no effect because no cigarettes were actually affected by the ban (menthol cigarettes are exempt) and the "lights" ban would have no effect because cigarette companies would start using coloring to convey the differences between "lights" and other brands.

Of course, Philip Morris knew all of this going into its negotiations with the Campaign for Tobacco-Free Kids. So the question is whether the Campaign was simply outsmarted by Philip Morris or whether the Campaign actually knew that this was the case and decided to deliberately mislead its constituents and the public.

Either way, the rest of the story is that the Campaign for Tobacco-Free Kids' and other anti-smoking groups' promises about the FDA tobacco legislation were false promises. They were pure propaganda, rather than science-based or evidence-based claims. And now the chickens are coming home to roost.

Is There Such Thing as a "Safer" Cigarette? Tobacco Regulation and the FDA -- The Bicknell Lecture at Boston University School of Public Health

Is there such thing as a "safer" cigarette? What are the public health implications of the FDA's new regulatory authority over tobacco products? Should electronic cigarettes be banned or promoted?

These are just a few of the questions that will be addressed at the 2009 William J. Bicknell Lectureship in Public Health to be held at Boston University School of Public Health. The event will be held on Friday, Oct. 23, from 9 a.m. to noon, in the first-floor auditorium of 670 Albany Street, on the Boston University Medical Campus. A continental breakfast will be available from 8:30 a.m. The event is free and open to the public.

I want to extend a special invitation to Rest of the Story readers, especially those in the Boston area, to attend this event.

The keynote speaker of the event will be Dr. Gregory Connolly, Professor of the Practice of Public Health at the Harvard School of Public Health. Dr. Connolly is a world-renowned expert on the control of tobacco products - including both cigarettes and smokeless tobacco - and was awarded the Surgeon General's Medallion by Dr. C. Everett Koop for his work in passing the Comprehensive Smokeless Tobacco Health Education Act. Before coming to Harvard, he served for many years as the director of the Massachusetts Tobacco Control Program, during a time in which the Commonwealth experienced a precipitous drop in cigarette consumption, both among adults and youths.

Dr. Connolly has conducted extensive research in the area of cigarette product design and his current research is very relevant to the issues facing the FDA in regulating cigarettes. His current work, for example, examines ways in which cigarette companies may circumvent the law's ban on "light" cigarettes and cigarette company techniques for increasing the addictive potential of their products. It will be very interesting to hear Dr. Connolly's views on the Family Smoking Prevention and Tobacco Control Act and whether or not there are specific ways in which he believes the implementation of this law could result in an improvement in the public's health.

Dr. Connolly's talk will be followed by reactions from three panelists.

Patrick Basham is the founding director of the Democracy Institute. He has conducted extensive research into the origins of the Family Smoking Prevention and Tobacco Control Act, resulting in a book published recently, entitled "Butt Out! How Philip Morris Burned Ted Kennedy, the FDA & the Anti-Tobacco Movement." In this book, Basham provides a detailed, extensive, and well-documented treatment of the origins of the FDA tobacco legislation. He describes, in no uncertain terms, how that legislation was the result of an unholy alliance between the Campaign for Tobacco-Free Kids and Philip Morris. For a detailed review of his book, see my previous blog post.

Dr. Cheryl Healton is the founding president and chief executive officer of the American Legacy Foundation. While the Foundation did not take any official position on the legislation that led to FDA regulation of cigarettes, it will be interesting to hear the Foundation's view of how that legislation should be implemented and how that implementation will, or will not, protect the public's health.

I will be the third panelist. As my readers know, I have been very critical of the Family Smoking Prevention and Tobacco Control Act from the onset. I view it as a public scam, in which the Campaign for Tobacco-Free Kids was suckered by Philip Morris into supporting legislation which will end up causing devastating effects on the public's health and undermining the very nature of federal public health protection in the nation. Nevertheless, I am coming in with an open mind and will be excited for the opportunity to consider and respond to the ideas presented by Dr. Connolly and the other panelists.

Following a brief break, the speaker and panelists will take questions from the audience and engage in discussion about the topics covered. Needless to say, it should be a fascinating symposium.

Washington Times Editorial Blows Lid Off FDA Tobacco Law; The Cat is Now Out of the Bag As Public Starts to Realize Bill Was a Sham

An editorial published last week in the Washington Times has blown the lid off the FDA tobacco law, exposing it for what it truly is: a sham.

According to the editorial, the Family Smoking Prevention and Tobacco Control Act's ban on cigarette flavorings accomplishes nothing because the only flavoring actually being used to recruit a substantial number of young smokers is menthol -- the one flavor which was exempted in the ban.

The editorial also argues that the law is especially toothless among the African American community, among which more than three-fourths of smokers choose menthol brands.

Furthermore, the editorial argues that the sole reason for the menthol exemption was to protect the financial interests of Philip Morris and retain its support for the legislation.

According to the editorial: "Until last week, all cigarette flavors were equal, then new Food and Drug Administration regulations made one flavor more equal than all the others. Because of a loophole written into the law, the FDA banned all flavored cigarettes except menthol. The only flavor sold by Philip Morris, the FDA's industry ally in passing legislation to allow the ban, just happens to be menthol. Sold as a way to protect public health, the ban is more flash than substance. At the time he signed the legislation President Obama crowed, "The decades-long effort to protect our children [has] emerged victorious. ... Today, change has come." Change came, but it didn't do much when it got here."

"Menthol is the No. 1 cigarette flavor used by underaged smokers and the most popular among all smokers. A menthol ban would have had many times the impact of banning all other flavors combined. The menthol exception makes the new regulation particularly toothless among blacks. Mentholated brands are preferred by three-quarters of black smokers. Blacks tend to be more likely to smoke and to smoke more. As a result, blacks suffer a disproportionate share of lung cancer." ...

"All the Big Brother health benefit rhetoric might have meant something if the single most popular flavored tobacco wasn't excluded. Instead we get government-expanding regulation virtually guaranteed not to have an impact. That's not change, that's business as usual."

The Rest of the Story

It's sad and it's true. Not only can the FDA tobacco law be criticized for creating a new federal bureaucracy, but it can also rightfully be criticized for creating a new federal bureaucracy that is going to accomplish nothing.

Not because federal intervention on the nation's leading cause of preventable disease is not warranted, but because the type of intervention specified by this law is nonsensical and toothless. The loopholes in the bill, which were successfully negotiated by Philip Morris and agreed to by the Campaign for Tobacco-Free Kids, ensure that the law will be full of sound and fury but signify nothing.

Shamefully, the Campaign for Tobacco-Free Kids continues to fail to acknowledge that the legislation was negotiated between itself (representing public health interests) and Philip Morris. Just read the latest issue of Tobacco Reporter for another dishonest denial of the truth - which is that the bill was the result of a Congressionally-mediated negotiation between two primary groups - Tobacco-Free Kids and Philip Morris.

Honesty is not the Campaign's strong suit. It didn't used to be Philip Morris' strong suit either, but I believe that Philip Morris has now surpassed the Campaign in terms of honesty. Maybe that's not saying much, but it's disturbing that an organization that is supposedly fighting dishonesty on the part of Big Tobacco should be so dishonest itself.

Also disturbing is the Campaign's willingness to use the health of African-Americans as a negotiating tool. It doesn't seem to me that the health of African-Americans was something which the Campaign could legitimately choose to compromise in order to retain Philip Morris' support for the legislation. Especially when there were no African-American groups at the table to be included in the discussions. Should you not consult with groups representing the very community whose interests you are selling out at the negotiating table before you do so? Ethics is not the Campaign's strong suit either.

What then is the Campaign's strong suit? It's deceiving the American public and its own constituents, making them believe that Philip Morris had no role in the crafting of the legislation, making them believe that this law will protect children from addiction and save lives, when the truth is that Philip Morris was a central negotiator and that the law is toothless and accomplishes almost nothing.

I used to think that the Campaign's true slogan could be something like: "Using Deception and Dishonesty to Protect Kids." But the unfortunate thing is that a more apt slogan would be: "Using Deception and Dishonest and Not Even Protecting Kids, Especially African-American Ones."

FDA Quoted as Stating that It's Not Sure Cigarette Smoking is Any More Dangerous than the Use of Electronic Cigarettes

According to an article by Jim Merkel of the newspaper St. Louis Today, the Food and Drug Administration (FDA) is quoted as stating it is unsure whether cigarette smoking is any worse than the use of electronic cigarettes.

Since hundreds of thousands of people are using electronic cigarettes - which contain no tobacco and deliver nicotine without the more than 10,000 other chemicals that are present in cigarettes - and many of them have been told by their doctors that their health has greatly improved since quitting smoking and switching to vaping, the FDA's statement is likely to be interpreted as meaning that cigarette smoking isn't all that bad, comparable perhaps to the use of nicotine replacement products, which are also relatively "clean" sources of nicotine.

According to the article, an FDA spokesperson was quoted as stating: "We don't know if this [electronic cigarette use] is any better for them [than smoking]."

Here is the full context of the discussion and quote:

"Julie Woessner puffs on an electronic cigarette and feels a vapor full of nicotine wafting deep into her lungs. Woessner and thousands around the country are passionate in their belief that the battery-powered sticks that deliver nicotine without burning have been lifesavers. "If I hadn't have had it, I'd still be smoking,' said Woessner, 46, a homemaker living in Wildwood. People like Woessner call themselves "vapers" because they "vape" or inhale vapor that includes nicotine from e-cigarettes. They worry the government may try to take away something they see as a lifesaver. "If that happens, I will be smoking again, and that makes me sick," said Woessner. She first used the device in January and immediately stopped smoking."

"FDA spokeswoman Siobhan DeLancey contends her agency wants to regulate electronic cigarette so it can be sure that the people who use them are getting a reliable dose of nicotine, and that there are no far-reaching health effects from long-term use. "There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term," DeLancey said. "What we want to see are well-designed clinical studies. Personal reports are not enough," DeLancy said. The FDA maintains e-cigarettes contain carcinogens and toxic chemicals like diethylene glycol, an ingredient in industrial antifreeze."

"But backers of e-cigarettes contend what is produced is much safer than cigarettes. ... Woessner expects to vape for years to come, but at a level with very little nicotine. "This is something the government should be pushing for, a clean way of allowing people to smoke," Woessner said. Delancey disagreed. "I feel their pain," she said. "We don't know if this is any better for them."

The Rest of the Story

If it is true that the FDA doesn't know if electronic cigarettes are any better (i.e., safer) than tobacco cigarette smoking, then it follows that the FDA also doesn't know if tobacco cigarette smoking is any more dangerous than using these personal vaporizers.

Since there are no known health threats that have been identified with the use of electronic cigarettes made by companies that use pharmaceutical grade propylene glycol (other than long-term effects of nicotine, which are of course also present with cigarettes), the FDA seems to be stating that there is at least a chance that cigarette smoking might not actually be as harmful as we think.

This scientific folly highlights the absurdity of having the FDA now approving cigarettes, but threatening to take the electronic ones - which contain no tobacco - off the market.

Since the Family Smoking Prevention and Tobacco Control passed, the FDA has done nothing little to warn the public about the risks of cigarette smoking, but as we see today, through its actions and statements on electronic cigarettes, is actually undermining the public's appreciation of the severe health hazards associated with conventional cigarette smoking.

This is, I'm sure, just what Philip Morris dreamed about when it concocted the idea of trying to seduce the Campaign for Tobacco-Free Kids into supporting very limited FDA regulation of cigarettes. It has created a situation where by statute, the FDA must approve deadly cigarettes for sale and consumption in the United States, but where the very same FDA is threatening to remove from the market a device which is actually helping perhaps hundreds of thousands of people to keep off of cigarettes.

When the FDA tells the public that cigarette smoking may be no more hazardous than the use of a device that essentially delivers just nicotine and propylene glycol, you know we have serious problems with tobacco control in this country.

President Obama Deemed Unqualified to Work in Palm Beach County Tax Collector's Office

Although he is the chief executive of the nation and is ultimately responsible for the collection of taxes from every individual and corporation in the country, the Palm Beach County tax collector's office has decided that President Obama is not qualified to serve as a tax collector in Palm Beach.

Why? Because President Obama has used tobacco products on a regular basis during the past 12 months, and according to a new Palm Beach County policy, he is not eligible to even apply for a job in the County's tax collection office.

Even an individual who had smoked cigarettes for 30 years and was using snus only as a means of trying to quit smoking would not be eligible for a job in the Palm Beach County tax collector's office. Moreover, it wouldn't matter if someone smoked 2 packs a day or just a couple of cigarettes a month -- neither could be hired under the policy, regardless of how well-qualified they might be for the position.

According to the Palm Beach County tax collector's web site, the purpose of the policy is as follows: "to create a positive healthy environment in the workplace for all employees while decreasing the costs which result from tobacco use."

The Rest of the Story

One troubling aspect of this story is that it represents blatant workplace discrimination. But another troubling aspect in my mind is the justification being given for the policy: it is not just about saving health care costs, but about creating a "positive healthy environment" in the workplace. But if you are going to say that the presence of a smoker makes it a negative unhealthy environment, then it would be equally the case that the presence of an obese person makes it a negative unhealthy environment. Or that the presence of someone who rarely exercises makes it an unhealthy environment. Or the presence of someone who uses tanning salons.

In other words, the justification for this policy is based on two things:

1. Lifestyle control; and
2. Bigotry.

This is lifestyle control because it fails to differentiate between smokING in the workplace and the presence of a smokER in the workplace. It would certainly be reasonable to have a voluntary weight loss program in the workplace. Doing so would be public health promotion. But requiring employees to enter the program or refusing to hire people who are overweight would be lifestyle control.

This is bigotry because it represents intolerant treatment of the members of a group (smokers) that appears to be based on animosity and irrationality. It is irrational not to hire smokers because smoking has nothing to do with workplace qualifications and because if one were to use health care costs as a criterion for employment, one would also be justified in denying employment to people who are overweight, obese, not physically active, or who have poor diets. You don't see employment discrimination against these latter groups of people because there does not exist a systematic, obstinate, hate-filled, and irrational intolerance of these groups.

That the mere presence of a smoker in the workplace would be deemed as translating into an "unhealthy, less productive working environment" is disturbing. By the same reasoning, one could argue that the presence of an overweight person in the workplace results in an unhealthy, less productive workplace.

By this token, I guess the Boston University School of Public Health is an unhealthy and unproductive work environment because I know at least one guy who works there who indulges in excessive quantities of Vienna Fingers.