Everything old is new again...
July 31, 2008

Below is an interview given to Bulletin reporter Andrew Overton by Michael J. McFadden on the day that the "Re-Run" Scottish heart attack study was making the headlines.

Subject: Interview: The Scottish Study...

Hello again Andrew!

Unfortunately the general public is not provided an opportunity to examine the study itself without paying for it or visiting the library.   However, working from the article provided and the study abstract I can make several comments.

The article states that 67% of the decreased admissions were among nonsmokers.  If the smoking ban had no effect at all and the decrease was due to something totally different (e.g. a newly marketed drug) we would have then expected 75% of the decrease to have been among nonsmokers since they make up 75% of the population.  It's puzzling that the drop seems to be less: one could almost argue that the relative risk for nonsmokers vs. smokers actually increased after the ban.

That could be due to smokers quitting in greater numbers, but despite the great care taken to collect questionnaires and biochemical data there's no information in the abstract at all about smokers quitting their practice.

Something that's worth noting, which you'll have already seen mentioned in the "Stiletto" booklet I sent you, is that this is once again another "re-run" study.  Go back into your news archives ten months ago on Sept. 11th, 2007 and you'll find the SAME study by the SAME people with virtually the SAME results being broadcast to headlines back then:  Non-smokers suffer fewer heart attacks after ban - Times Online    One of the standard media tricks of the antismoking lobby is to seemingly double or triple the number of studies so that people think there are "mountains of studies" that support smoking bans.  Actually, researchers will usually get their work into headlines with some sort of preliminary "peek" at the work they're doing, then maybe again with some sort of full initial presentation or "online advance release", and then yet AGAIN when the full study itself is made available to subscribers to medical journals for examination.  And of course there are also "studies" that get announced and headlined that never actually make it to the medical journals because they couldn't meet even the minimal standards required for studies that support the goals of "public health."

I believe there have actually been fewer than ten studies fully published at this point that examine post-ban heart attack rates.  After analysis by neutral researchers such as Dr. Michael Siegel of Boston University, virtually every one of them has been found to be seriously defective in one way or another, either in their design, content, or presentation.  I would expect this Scottish study to be the same story.

If you believe in spiritualism and a clever Medium calls up your dead aunt and you hear knocks on the table and see the lights flicker, you'll believe she's there.  If you *don't* believe in spiritualism you'll know that one way or another, even if you can't see the hidden ropes and wires, that underneath it all....   it's a fake.  Given the history that I have seen of how antismoking-oriented and antismoking-funded studies twist the science and presentations to reach the desired politically correct goal I have to admit to *very* serious doubts about these new headlines for a study that was basically already done and headlined last September.

For further reading on and analysis of the Scottish study, I'd highly recommend Dr. Siegel's blog.   Dr. Siegel is an "Antismoker" by most definitions of the word: he has published and spoken extensively in favor of workplace smoking bans and against Big Tobacco.  During the past few years however he became disgusted with the chicanery and lies promoted by the great majority of antismoking organizations and he has been outspoken in his criticism of fakery, scare-mongering, yellow journalism, and the perversion of real scientific research in the pursuit of political and social-engineering goals.

I would *strongly* recommend that you take at least five to ten minutes to look over the criticisms of this study that were mounted when it was in its first presentation to the public.  See Dr. Siegel's blog entry on it and be *sure* to read the comments that follow: many of them are far more insightful and knowledgeable than you'll ordinarily see on the web.

The Rest of the Story: Tobacco News Analysis and Commentary: September 2007

The Scottish study is the third one down.  You might find the second and third blog entries, the ones concerning a similar NY study and concerning nicotine "spiking" by Marlboro, of interest.   Consider how extensive media coverage of such initial claims leaves a strong general public impression, almost a weltanschauung, of "facts" that simply and truly are not facts at all.

Heh...  the above is probably FAR more than you wanted or needed for your article but feel free to quote me as you wish from it as long as you don't obviously distort my meaning.  (I had the sad experience of a Canadian journalist a year or so ago who took a line of dialogue out of a VERY clearly labled satirical piece I'd written and attributed it to me as a serious statement. The bugger had never even contacted me but wanted to give the impression he'd interviewed both sides: the "scientists," and the "wackos.")

Hmm... one final important note (if your article or another is large enough): the LARGEST study ever done of post ban heart attacks showed NO decrease at all, and actually some statistically nonsignificant increases.  The unfunded study, done almost two years ago by David W. Kuneman and myself, covered entire US States with extensive bans to those with virtually no bans.  It was turned down by the BMJ for publication because, as the editors stated, "Our main problem with the paper was that we did not think it added enough, for general readers, to what is already known about smoking and health."   In other words, the one study, and the largest study, which did not agree with the politically desired result, didn't add anything of interest to "what is already known" ....  despite drawing a diametrically different conclusion from every antismoking-funded study to date.  See: 

ACSH > Facts & Fears > Archives

for the full story.

Michael J. McFadden
Author of Dissecting Antismokers' Brains
Mid-Atlantic Director, Citizens Freedom Alliance, Inc.
Director, Pennsylvania Smokers' Action Network (PASAN)
Dissecting Antismokers' Brains - Amazon

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This commentary, posted today on my tobacco policy blog at http://tobaccoanalysis.blogspot.com/2008/08/no-reduction-in-heart-attacks-in-wales.html, documents that there was no decline in heart attack admissions in Wales during the first 9 months in which the smoking ban was in effect. These results are inconsistent with the recent report from Scotland that the smoking ban resulted in a 17% reduction in heart attacks. Unlike the Scottish study, which relied upon two completely different data sources and only includes a fraction of hospitals in the country, the Wales data are based on a single consistent source of data for the past four years and includes all hospitals in the country. Without question, the data from Wales are far more reliable and meaningful than those from the Scottish study.

The problem with anti-smoking groups being so quick to embrace studies with very poor science (Helena, Pueblo, Bowling Green, etc.) is that when a study like this one in Wales comes out - using exactly the same methodology - but finds results which do not support our conclusion, we have no possible defense left to argue against the study findings. We have already embraced this kind of science as being appropriate to answer this research question. I'm afraid we have now hoisted ourselves by our own petard.

There is enough solid science about the health effects of secondhand smoke that we do not need to resort to shoddy science to support our international call for workplace smoking bans. In fact, since solid, national data (both Wales and England) is failing to show any substantial effect of smoking bans on heart attacks, using this as a reason to implement smoking bans is a losing proposition and is going to detract from our core argument. What are we going to do when well-conducted, longer-term, systematic studies fail to confirm the findings from earlier studies?

For detailed commentary on the flaws in the Scottish smoking ban study, see these two commentaries:

New Research Article Concludes that Smoking Ban in Scotland Caused a 17% Reduction in Acute Coronary Events; Comparing Apples to Oranges

http://tobaccoanalysis.blogspot.com/2008/07/new-research-article-concludes-that.html

IN MY VIEW: Another Reason Why Conclusion of Scottish Smoking Ban Study is Invalid - Effect May Have Been Due to Diagnostic and Treatment Changes

http://tobaccoanalysis.blogspot.com/2008/08/another-reason-why.html

Data from Wales released by Christopher Snowdon yesterday 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. Snowdon obtained monthly data on heart attack admissions from all Welsh hospitals for the years 2006 and 2007. 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, according to Snowdon.

When analyzing the data by month, Snowdon found that 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).

The Rest of the Story

Although 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), this did not stop anti-smoking groups from claiming that the smoking ban in Wales led to a reduction in heart attacks.

How did the anti-smoking groups pull off this miraculous feat, given that the data so clearly indicate no reduction in heart attacks?

They used a technique known as cherry-picking. By citing data for the few specific months in which there was a decline in heart attacks from 2006 to 2007, they purported to show that the smoking ban had resulted in a reduction in heart attacks.

In an article published this past June in The Daily Post, Action on Smoking and Health (UK) was quoted as saying: "It seems likely that the drop in hospital admissions for heart attacks is linked to the implementation of the smoking ban. It shows just how quickly the benefits can be felt."

What data were ASH referring to in making this pronouncement? Clearly, it was not the data for the first nine months after implementation of the smoking ban (April through December).

It turns out that ASH was citing data cherry-picked for the months October through December. Compared to the corresponding period in 2006, this three-month period in 2007 saw a 13% decline in heart attacks.

Had ASH examined data for the full period of April through December (which was obviously available at the time of its pronouncement), it could have come to no conclusion other than that there was no decline in heart attacks associated with the first 9 months of the smoking ban.

In an article published in Wales Online, the British Heart Foundation is quoted as stating: "These new statistics are very significant, and indicate the smoking ban has had a beneficial effect on the number of heart attacks quicker than many people predicted."

What "new statistics" is the British Heart Foundation referring to which purportedly demonstrate that the smoking ban in Wales resulted in a reduction in heart attacks?

Once again, it turns out that the British Heart Foundation is referring to the cherry-picked data from October through December of 2007 which reveal a 13% decline in heart attacks during these months compared to the corresponding period in 2006. But a broader look, which includes all 9 months following the smoking ban, confirms that there actually was no change in heart attack admissions. Apparently, these three months were cherry-picked in order to show an effect.

Implications of the Rest of the Story

There are three important implications to this story.

First, these data cast doubt on the conclusion of studies - such as the report from Scotland published last week - that smoking bans result in a dramatic, immediate drop in heart attacks. There seems little doubt that such a decline was not observed in Wales, a result which seems inconsistent with the conclusion of these other studies.

Second, it will be interesting to see whether anti-smoking groups acknowledge these data or ignore them. Are anti-smoking groups interested in the truth, or are they only interested in results which support their pre-determined conclusions?

Third, this story demonstrates that anti-smoking groups are not relying on solid science to draw their conclusions about the effects of smoking bans on heart attacks. They are willing to rely on cherry-picking of a fraction of the relevant data to draw their conclusions and make their pronouncements to the public.

It's quite clear that anti-smoking groups are prepared to rally around and tout the results of any study that draws favorable conclusions, regardless of the quality of the science. But what's most interesting to me is that we in tobacco control have denounced smoking ban opponents for relying on studies with exactly the same tactics - cherry-picking of data - in order to "demonstrate" that smoking bans result in a decline in restaurant sales. How can we on the one hand denounce studies that do not consider all relevant data and come to unfavorable conclusions and then on the other hand tout the results of studies using the same methodology which come to favorable conclusions?

Will the British Heart Foundation and ASH now retract their earlier statements and apologize to the public for drawing and disseminating premature conclusions? I doubt it. This is why it is essentially that we get it right the first time around.

But when your sole criterion for scientific quality is whether the study results support your pre-determined conclusion, it is going to be difficult to get it right the first time, or any time.

   

Michael Siegel, MD, MPH

Professor

Associate Chair of Academics

Social and Behavioral Sciences Department

Boston University School of Public Health

801 Massachusetts Avenue, 3rd Floor

Boston, MA 02118

617-638-5167

FAX 617-638-4483

Email: mbsiegel@bu.edu

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New  Research Article Concludes that Smoking Ban in Scotland Caused a 17% Reduction in Acute Coronary Events; Comparing Apples to Oranges

July 31, 2008

New Research Article Concludes that Smoking Ban in Scotland Caused a 17% Reduction in Acute Coronary Events; Comparing Apples to Oranges
A study published in the current issue of the New England Journal of Medicine reports that the smoking ban in Scotland resulted in a 17% decline in hospital admissions for acute coronary syndrome (including myocardial infarctions [heart attacks] and unstable angina) (see : Pell JP et al. Smoke-free legislation and hospitalizations for acute coronary syndrome. N Engl J Med 2008; 359:482-491).

The study compared the number of admissions for acute coronary syndrome in nine hospitals in Scotland (representing 63% of admissions for acute coronary syndrome in the country) during the 10-month period prior to the smoking ban and the corresponding 10-month period the following year. The number of admissions declined from 3235 to 2684, a drop of 17%.

This 17% drop was compared to the trend in overall hospital admissions in all of Scotland during the preceding 10 years. According to the study, "the trend during the 10 years before legislation was a 3% mean annual reduction, with a maximum reduction of 9% in 2000."

Because the observed 17% reduction in admissions for acute coronary syndrome was much higher than the annual reduction during the 10 previous years and exceeded the highest annual decline between any two years, the study concludes that the observed reduction is attributable to the smoking ban.

The Rest of the Story

The problem with this article is that its conclusion is based on a comparison of apples to oranges. In order to compare the change in heart attacks in Scotland from 2006-2007 to the trend in heart attacks during the preceding ten-year period, one needs to use the same data source to compare these trends.

In this article, the researchers use one source of data to estimate the change in heart attacks from 2006-2007 (observed changes in admissions for nine hospitals representing a portion of the country) and a different source of data to estimate the trend in heart attacks from 1996-2006 (national data from the Scottish National Health Service).

A critical basis for the article's conclusion is that the year-to-year decline in heart attacks in Scotland never exceeded 10%, while the researchers found a 17% decline in heart attacks during the year following the smoking ban.

However, the relevant question is not what the national health service data show, but what changes in heart attack admissions would have been found using the same methods employed by the researchers to count heart attack admissions for 2006-2007. What would the annual changes have been using the same 9 hospitals and using the same method of counting heart attack admissions?

It is important to note that:

(1) The diagnosis of acute coronary syndrome in 2006-2007 was based on an assay for cardiac troponin (a component of cardiac muscle which is released into the blood following heart injury), which is a very sensitive test for cardiac injury. For the period 1996-2006, the diagnosis was likely made based on less sensitive measures, since the use of troponin to diagnose coronary syndrome has greatly increased in recent years.

(2) The random variation and secular trends in coronary syndrome for the 10-year period prior to the smoking ban are based on standardized, national data which include the entire country of Scotland. Thus, the variation is likely to be much lower than the variation in the data from a sample of just 9 hospitals.

The correct way to conduct this analysis would be to examine the trends in heart attacks in all of Scotland for the entire ten-year period using a single, standardized and consistent data source and then to examine the degree of random variation in year-to-year changes in heart attacks and see if the observed change associated with the smoking ban is inconsistent with the magnitude of observed year-to-year changes during the years preceding the smoking ban.

Fortunately, the annual data on heart attack admissions in Scotland is available online, so we can examine the magnitude of year-to-year changes in heart attacks in the past decade and see how the change associated with the smoking ban compares.

Remember that the smoking ban was implemented in March 2006, so changes from 2005 to 2006 would reflect the smoking ban, as would changes from 2006 to 2007.

Between 2005 and 2006, the number of heart attack admissions in all of Scotland declined by 4.2%. Between 2006 and 2007, the number of heart attack admissions in Scotland dropped by 8.0%.

That might sound like a big drop, large enough that we would conclude it was due to the smoking ban.

However, look at the year-to-year declines in heart attacks in Scotland in years prior to the smoking ban.

Between 2003 and 2004, heart attack admissions declined by 4.6%. This is greater than the observed heart attack decline from 2005 to 2006.

Between 1999 and 2000, heart attack admissions in Scotland declined by 10.2%. This is much greater than even the 8.0% decline observed from 2006 to 2007.

Even if we look at the 2-year decline in heart attacks from 2005 to 2007, it is about the same as the 2-year decline observed bewteen 1999 and 2001 (11.9% compared to 10.7%).

If I present the data this way, it makes it clear that the observed change in heart attacks associated with the smoking ban is not at all out of the range of normal declines in heart attacks from year to year in Scotland observed in the absence of the smoking ban.

2005-2006: -4.2% 2003-2004: -4.6%
2006-2007: -8.0% 1999-2000: -10.2%

My point here is not that these data prove there was no decline in heart attacks in Scotland attributable to the smoking ban. My point is merely that there is no way one can conclude that the observed decline in the year following the smoking ban was different from the magnitude of the declines observed in previous years.

The analysis in this paper assumes that the entire observed change in heart attacks is attributable to the smoking ban. However, it is clear that a 10.2% decline in Scotland from 1999-2000 occurred in the complete absence of a smoking ban. Clearly, there are other factors which are contributing to a decline in heart attacks, there is a secular trend of substantially declining heart attacks over time, and in fact, the magnitude of the decline associated with the smoking ban is less than the magnitude of the decline observed in some recent years preceding the smoking ban.

In other words, one cannot rule out the very plausible alternative hypothesis that the observed decline in heart attacks is explained by random variation in the data and the already existing secular trend of declining heart attacks in Scotland.
http://tobaccoanalysis.blogspot.com/2008/07/new-research-article-concludes-that.html