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Tobacco and the Heart Symposium

Eye and Heart at Mortal War:
Coronaries and Controversy in a Smokefree Scotland

Martin Dockrell

Action on Smoking and Health (ASH) UK

Reproduced from Expert Rev. Pharmacoeconomics Outcomes Res. 9(1), 23–27 (2009)
with permission of Expert Reviews Ltd


SUMMARY
A study1 is published in one of the world’s most reputable medical journal’s and is rated “must read” by the prestigious Faculty of 1000 101 yet described in the BBC web News Magazine - even before it is published - as looking like “over-hasty, over confident research” 102and ranked among “the worst junk stats” of the year by a Pro Vice Chancellor of Oxford University. 103   Amid scenes reminiscent of AIDS conferences of the 1980’s, researchers on their way into hear the initial presentation had to cross a line of angry pickets waving ‘Junk Science’ placards. The issue is controversial enough to provoke the “First World Congress on Smoking Bans and Lies” in January 2009 and it is precisely the rapidly growing weight of evidence, rather than the lack of it, that has made it a battle ground in an emerging clash between the public health community and those who deny that secondhand smoke kills.

Keywords
Smoke-free, Policy, Acute Coronary Syndrome, Environmental Tobacco Smoke, Conspiracy, Junk Science

Summary of methods and results
Published studies demonstrating the impact of smokefree legislation on coronary health have been the subject of reviews 2 3 and meta-analyses. 4 5 Every published study has found a significant fall in adverse coronary events following the introduction of smokefree legislation for a major segment of the population. There is not a single exception in the scientific literature. 

Like all real world research, these studies have differing strengths 

  • Although US studies of the impact of smoke-free legislation on hospital admissions for acute myocardial infarction in small towns were able to use neighbouring jurisdictions as a control those where implementation was national (notably, the Italian studies) have not.
  • Most studies have not considered out of hospital deaths for acute myocardial infarction, although there are concerns about the reliability of coding for cause of death..
  • Some report after only a brief intervention period (in one case this was as short as 2 months), though the effects of smokefree legislation on health occur quickly.
  • Only two of some ten studies report the smoking status of those admitted to hospital for acute myocardial infarction. Similarly, few studies provide robust information on compliance with smoke-free legislation. While this makes little difference to measuring the scale of the effect, the data would have helped us better understand the process.
  • Pell’s StopIt study forms part of a comprehensive suite of investigations designed to analyse the effect of smokefree legislation in Scotland, allowing investigators access to an unusual wealth of data and drawing lessons from the data and methodology of earlier studies. 6 StopIt examines admissions for Acute Coronary Syndrome (ACS) in 9 Scottish hospitals in the 10 months before and the 10 months after Scotland went smokefree in March 2006.  Between them, these hospitals serve 63% of Scotland’s population of just over 5 million. Data were collected on all patients admitted with ACS, defined as detectable levels of cardiac troponin after an emergency admission for chest pain (an innovation unavailable to some earlier studies). Troponin levels were measured routinely in these patients and participation was extremely high.  Smoking status was determined at admission and cotinine assays were used to validate self-reporting and measure exposure to secondhand smoke.  Routine data collected in Scotland over many years and Hospital Episode Statistics from England provided historical and geographical context to the findings.

    After the legislation came into force the Scottish Government recorded 97% compliance7 and data from other research in the evaluation strategy found levels of smoke in bars (measured as particulate matter PM2.5) down by 86%8  and measured cotinine levels in the general population greatly reduced.9 Out of hospital deaths comprise a major part of AMI cases (around 40% in Scotland) and the StopIt study was able to include these accurately, observing a decrease of just over 5%.

    Pell and colleagues observed the number of admissions for ACS to fall by 17% with the decrease in monthly admissions accelerating over time. Admissions among “never smokers” fell fastest (21%) especially among women, but also fell dramatically among ex-smokers (19%) and smokers (14%).  The authors compare the reduction in ACS with a reduction of 4% in cases of Acute Myocardial Infarction (AMI) in England over the same period and a background decline in AMI in Scotland of an average of 3% per year in the preceding decade.

    Discussion
    It was almost a quarter of century after Aronow demonstrated the link between exposure to secondhand smoke and the rapid onset of chest pain10 before the first legislators began to enact comprehensive smokefree legislation. Pioneering legislators were accompanied by path finding evaluators who soon identified rapid benefits in coronary health. Among the first was Sargent and colleague11 who found a startling 40% reduction in admissions for AMI in Helena Montana. Sceptics pointed to the town’s small population of 68,000 and the fact that the study covered only 64 admissions but other studies including one by Bartecchi12 followed and as the size of the jurisdictions passing smokefree ordinances grew so too did the size of the studies. The emerging evidence from the US combined with a growing body of evidence on the wider harm from secondhand smoke13 persuade European legislators to act. Before long this legislation too appeared to be yielding similar benefits in Italy14 and Irelan15and in 2007 an evaluation of the 2002 legislation in Bowling Green Ohio found a 47% reduction in smoking related diseases over 3 years. 16Critics who claimed Bowling Green was too small a jurisdiction to offer meaningful data could scarcely make the same criticism when the New York State Department of Health (population 19 million) claimed their Clean Indoor Air Act resulted in 3,813 fewer admissions for AMI, a fall of 8% for the state-wide measure. This drop was more remarkable than might first appear as much of the state was already covered by local smokefree ordinances and it is estimated that the combined effect of local and state legislation was a 19% drop in AMI..17Once Dinno and Glantz published their meta-analysis3 the question changed irrevocably from “whether” to “how much?”, a question Glantz has returned to in his recent update. 4

    As Glantz observes, ‘the fact that many studies from so many locations around the world provide consistent finding of a substantial drop in AMI’s associated with the implementation of smokefree laws increases the confidence that we can have that smokefree law has immediate and substantial benefits in terms of reducing AMI”. The results from the Scottish study fall well within the range already in the literature, perhaps somewhat less than the 40% reported by Sargent et al, and rather more than the 11% reported by Barone et al but certainly very close to Glantz’s pooled estimate of 19%. So here we have a study which tries hard to learn the methodological lessons and difficulties of its predecessors yet still finds results consistent with those earlier studies. What about it provokes such vituperative rejection?

    Brewis and Grey18 have sought to characterize the regulation of smoking at work as a “moral panic” based on evidence which they say “remains heavily contested”. According to Brewis and Grey, “it is not exaggeration then to say that smoking is becoming stigmatic in very much the sense that Goffman applied the term to ‘deviant’ behaviour such as drug addiction, prostitution and crime”. They suggest that smoking has, like “masturbation and homosexuality become medicalised as harmful to health” and that smokefree workplaces “could be seen as a manifestation of the Foucauldian concept of dressage – a ‘discipline’ or ‘taming’ of employees who smoke, not for reasons of enhancing productivity but rather for the satisfaction of the controller and as a public display of compliance, obedience and discipline”.  

    The demonstrators who gathered outside the conference centre in Edinburgh in 2007 to reject as junk,  science which they had not yet heard - and who hold their “First World Congress” in 2009 - may or may not consider themselves “Foucauldian”; however they have described themselves as “freedom fighters19 inviting other smokers to “join the resistance” 20 and their opinions resonate with Brewis and Grey, appearing to share a view that smokefree legislation is the product of an illiberal conspiracy between clinicians, scientists and legislators, motivated not by public health but by a secret, perhaps unconscious desire to control. Like Brewis and Grey, their opinion appears not to be derived from the scientific evidence but adhered to in defiance of it. 

    Their position echoes the so called “AIDS Dissidents” who continued to contest that HIV was the causal agent in AIDS long after the scientific debate was over.  Irrelevant in serious scientific debate, they exercised a disproportionate influence among patients, and populations at risk. Conspiracy theories were propagated, researchers received death threats, public health messages were undermined and patient practitioner relationships poisoned. 21   The self styled dissidents even had some success in influencing policy, delaying the promotion of safer sex and the provision of effective pharmacotherapy in one of the countries most in need of an evidence based AIDS policy.22  In a recent comment article in the Lancet, Sharp observes “with exceptions such as HIV/AIDS, clinical and research efforts need not be diverted to deal with such conspiracy ideas. Trickier to handle are allegations of conspiracy that are not wildly presented and which seem to be taken seriously by members of groups not ordinarily thought of as gullible or indeed powerless23

    There is nothing new about branding tobacco research as “junk science”. 24 25It is a term associated with tobacco industry lobbyists ever since they tried to discredit the link between smoking and cancer. Industry tactics include:

    • Manufacturing uncertainty: According to one tobacco executive “doubt is our product since it is the best means of competing with the body of fact that exists in the minds of the general public. It is also the means of establishing controversy”. 26
    • Challenging causality: On the advice of PR advisors the tobacco industry has consistently emphasised three points: “that cause and effect relationships have not been established in any way; statistical data do not provide the answers and that much more research is needed”. 26
    • Coaching “Third party” advocates: Camouflage efforts to undermine research by creating the impression of unbiased scientific evidence. 27
    • If you can’t win, delay: Argue the evidence at each step to delay and discourage future reforms. In a presentation to his Board of Directors, Philip Morris International’s Head of Government Affairs described the strategy as throwing “sand in the gears” of regulatory reform. 28

    Perhaps the most influential critics of the StopIt study, Blastland and Dilnot, are routinely cited by the tobacco “dissidents”.  The authors, who collaborated on the BBC Radio 4 series More or Less, have published their criticism on the BBC website 101 and the Times newspaper103 and were cited in the Times blog of  Daniel Finkelstein, an influential columnist and former Director of the Conservative Party’s Conservative Research Department. In the BBC article Blastland takes as his starting point media coverage of the conference report in September 2007 and contrasts the reported findings of Pell et al with routine hospital activity data published two months later which shows a decline he describes as of “about 8%” and asserts “the percentage falls in the three years before the ban were 5.1%, 4.7% and 5.7%” and cites “an even larger drop between 1999 and 2000 of about 11%” concluding “any claims about causation now look premature.” Blastland goes on to criticise the authors because two months after the conference presentation “the data on which the StopIt study was based has never been published”,; he points out that patients had the option to opt out of the study (implicitly introducing a bias), and criticises the researchers for failing to enter into a dialogue with journalists. Like the protesters outside the conference centre, Blastland and Dilnot had rejected the research before they had the opportunity to look at it.

    It is unfortunate that Dilnot and Blastland use the term “junk”. There is nothing new about branding tobacco research as “junk science”. 29 30 It is, a term associated with tobacco industry lobbyist ever since their efforts to contest the link between smoking and cancer. Industry tactics have included:
    • Manufacturing uncertainty: According to one tobacco executive “doubt is our product since it is the best means of competing with the body of fact that exists in the minds of the general public. It is also the means of establishing controversy”.31
    • Challenging causality: On the advice of PR advisors the tobacco industry has consistently emphasised three points: “that cause and effect relationships have not been established in any way; statistical data do not provide the answers and that much more research is needed”. 261
    •  
    • Coaching “Third party” advocates: Camouflage efforts to undermine research by creating the impression of unbiased scientific evidence.32
    • If you can’t win, delay: Argue the evidence at each step to delay and discourage future reforms. In a presentation to his Board of Directors, Philip Morris International’s Head of Government Affairs described the strategy as throwing “sand in the gears” of regulatory reform. 33

    Blastland’s criticisms of Pell et al

    • Researchers were slow to publish their data
    • Findings do not match routine hospital discharge data
    • The decline in heart attacks is part of a long term trend
    • The study does not provide proof of causation
    • Researchers have been unwilling to discuss their research with journalists

    It is entirely normal for researchers to present their initial findings at conferences for a discussion between colleagues in advance of peer reviewed publication and that to publish in a peer reviewed journal. Given that the journal involved is among the most influential in the world,34 the time taken to publish is in no way unusual.

    Pell makes no secret of the difference between the data from the StopIt study and the routine discharge data. Indeed, she is among the authors of a paper presented at the same conference of an analysis of precisely that routine discharge data (adjusted to take into account variations in climate which can influence AMI admissions). 35 Although Pell and colleagues had access to the AMI discharge data, the StopIt study refers to Acute Coronary Syndrome, a broader measure for heart attacks, verified by assay.  The study examines the discharge codes for patients included under their ACS definition and finds that only around half receive a code consistent with AMI and the rest uninformative codes. This, in itself, is interesting and requires further investigation

    Pell also specifically acknowledges the long term trend, also noting the exceptionally large drop in AMI admissions in 1999-2000 and refers to the 10 year average decline while Blastland cites only to the previous three years. Neither Pell nor Blastland offer any explanation for the drop in 1999-2000 although that winter is described as “the sunniest on record” with monthly average temperatures in Scotland from January to March 1.5 - 2oc warmer than normal. 104

    Blastland also claims that the study does not demonstrate causation, an assertion he repeats with reference to similar reports from Wales.105 There is good reason to question the Welsh data which was not a peer reviewed study but given that one of Hill’s criteria for causation is consistency across studies, it is impossible for a single study – however strong - to demonstrate causation. So how does StopIt fair against Hill’s other criteria for causation? Clearly Pell’s findings combine with the body of published evidence do demonstrate a strong and consistent, temporal link. That is to say, repeated studies have measured incidence of heart attacks prior to legislation and observed a decline afterwards and the use of neighbouring jurisdictions as controls from Sargent to Pell .strengthen the findings.  The hypothesis is plausible and coherent, being based on 20 years of observational and experimental evidence on the effect of secondhand smoke on the cardiovascular system.  For those not convinced by the sharp rise in heart attacks observed when the Helena statute was overturned, Pell shows the effect of legislation increases with each successive smokefree month combined with Pell offers us offers potent evidence of dose response and underscores it with the direct measurements of cotinine levels to offer potent evidence of dose response.  

    Blastland’s final complaint is that “attempts to obtain it [the data] or talk to the lead researcher have gone unanswered”. Perhaps the answer lies in Blastland’s own observations on what he calls “the furry of excitable headlines”. If some of these issues could have been clarified by the authors, given the ‘excitable headlines’ and Blastland’s own niche journalism, it is scarcely surprising that Pell has been as reluctant to enter the media fray as Blastland and Dilnot have been to subject their analysis to peer review.

    Blastland concedes it is ‘perhaps unlikely that the smoking ban had no effect at all” but the tone of his comments has meant this point has been lost on many of his readers.His web story on the BBC ends with a sort of declaration of competing interests, Blastland and Dilnot are authors of The Tiger That Isn’t – Seeing through a world of numbers. In their Guardian article106 is preceded by the text  “Governments are quick to roll out statistics to prove that initiatives are – or are not – working. But mostly, the sums just don’t add up”. It was, no doubt the intention to deliver politicians and scientists a poke in the eye with a sharp shtick but now it appears that it was Blastland and Dilnot who were “over hasty and over confident”.

    By way of a post script, several UK media outlets including the Times 107 subsequently reported that heart attacks in England had fallen by “up to 40%”. The source for their excitable headlines was not a peer reviewed publication, nor even a conference paper. Their source was a piece published in a rival newspaper using raw discharge data from English hospitals and like the Welsh data was not peer reviewed. When the peer reviewed data is eventually published it is unlikely to match the media’s claims. Neither the public nor the public health is served by this kind of journalism and we can only hope that the damage done through public misunderstanding and conspiracy theories cost fewer lives this time than with AIDS.


    Five Year View
    In our editorial in this Journal in the summer of 200736on smoke-free public places and their impact on public health we were able to point to only limited evidence to the impact of legislation on coronary health outcomes but less than 6 months later when we asked “Does ‘smokefree’ really make a difference to coronary health?”2 the question had become rhetorical. Rigorous studies such as Pell’s will not only improve our understanding of the effect of secondhand smoke on coronary health, they will inform government policy, enabling politicians around the world to protect the health of their citizens. Media coverage which exaggerates or denigrates the impact of such work will continue to fuel “dissidents” and conspiracy theorists but it is to be hoped that as more and larger jurisdictions evaluate their legislation with rigour, acute controversies will decline almost as fast as acute coronaries have done.

    Key Issues

    • Smokefree legislation has reduced heart attacks in Scotland as in every jurisdiction with a published evaluation.
    • This research contributes to evidence of a clear causal link between smokefree legislation and a population level improvement in coronary health.
    • While AIDS dissidence was largely an indigenous phenomenon, tobacco dissidence is the carefully conceived creature of tobacco industry lobbyists.
    • The journalist and blogger’s impatience does not always contribute usefully to public understanding of the issue.
    • Organised groups who seek to deny and discredit this work are comparable in nature and intent – but not in origin - to the self styled AIDS dissidents who continue to deny the causal link between HIV and AIDS and offer a comparable threat to evidence based health policy.

    Financial disclosures & acknowledgement
    The author has no relevant affiliation or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership, or options, expert testimony, grants or patens received or pending, or royalties. The author considers that his employment with Action on Smoking & Health does not constitute a conflict of interest as their goal of minimizing the harm from smoking is served best by even-handedly assessing the effectiveness of public health interventions.
    No writing assistance was utilized in the production of this manuscript.

    BIBLIOGRAPHY

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CV of the author
- He Is Director of Policy and Public Affairs at ASH, a campaigning charity based in London
- He joined ASH after leaving Asthma UK where his main interest was researching the patient experience. Previously he worked in HIV prevention and was Chief Executive of the UK charity Gay Men Fighting AIDS
- He has a particular interest in community based research




 

 




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