Showing posts sorted by relevance for query 17 percent heart attack study. Sort by date Show all posts
Showing posts sorted by relevance for query 17 percent heart attack study. Sort by date Show all posts

Tuesday, December 02, 2008

Challenge to Anti-Smoking Groups to Publicize Two-Year Data from Scotland on Trends in Heart Attacks

Today I am challenging anti-smoking groups to publicize the two-year follow-up results of trends in heart attacks or acute coronary syndrome in Scotland since the smoking ban went into effect.

The first group to do this will receive a $200 donation to their organization.

The rules are quite simple:

1. To be eligible, an anti-smoking organization must have previously issued a public communication (including a web site posting), press release, or media statement in which it publicized the results of the Scottish smoking ban study (either the original press release before the study was published or the results of the published paper in the New England Journal of Medicine) and communicated to the public the conclusion that the smoking ban in Scotland led to an immediate, dramatic (17%) decrease in heart attacks (or acute coronary syndrome) in Scotland.

2. The organization must issue a public correction of the conclusion of the study, either through a press release, web site posting, or other major public communication, based on the complete two-year follow-up data, which demonstrate no significant effect of the smoking ban on admissions for acute coronary syndrome in Scotland.

The Rest of the Story

The rest of the story is that I cannot afford the $200 prize I am offering, especially given the stock market crash, which was seriously exacerbated yesterday. However, I am so convinced that no anti-smoking organization will take up this challenge that I am willing to put the money on the line.

Why am I so sure that no anti-smoking organization will take up the challenge?

Because as I have learned, these anti-smoking groups aren't truly interested in getting out the facts. They are interested in putting out information which is favorable to their cause. The goal is not scientific accuracy or integrity. It is putting out information to support the agenda. If that information turns out to be premature or wrong, so what? It's all for a good cause anyway, so there's no real harm in a little bit of premature or false information. After all, the movement is saving lives.

Now some might argue that there is nothing wrong with anti-smoking groups being biased and even inaccurate in their reporting of the science because this is what partisan advocacy groups do. I disagree, however, because I view anti-smoking groups as part of the public health movement and because they have put themselves forward as being a credible source of scientific information. In other words, these groups have taken on a responsibility to the public by virtue of their putting themselves in the position of advocating for policies to improve the public's health. Moreover, they have put themselves forward as accurate communicators of scientific information to the public. In fact, much of these groups' work is dedicated to criticizing the tobacco companies for their misleading scientific statements to the public.

You can't have it both ways. If you are going to criticize the tobacco companies for being biased and inaccurate in their communication of the scientific facts about smoking and secondhand smoke to the public, then you cannot justify being inaccurate in your own communications.

I am not going to lose sleep worrying about my $200 because I am sure that no anti-smoking groups will respond appropriately. This is not about the scientific truth. It is about putting out information that supports these groups' agenda (and agenda that I largely support, by the way). However, where I differ is that I believe that these groups should be promoting these policies based on sound science, not inaccurate science that results from biased and premature conclusions that turn out to be wrong.


Examples of Groups Which Communicated the Original Study Conclusions to the Public

Campaign for Tobacco-Free Kids: "Since the implementation of its smoking ban, Scotland has seen a 17 percent reduction in heart attack admissions in 9 major hospitals."

Americans for Nonsmokers' Rights: "A study of nine Scottish hospitals has found a 17 per cent fall in admissions for heart attacks in the first year after the smoking ban came into force."

American Heart Association: "A public smoking ban in Scotland reduced hospital admissions for heart attacks by 17 percent in one year, according to researchers at the University of Glasgow, Scotland. The ban was most beneficial for people who had never smoked (21 percent reduction in hospitalizations) and former smokers (19 percent reduction). Hospitalizations decreased by 14 percent among smokers. In the decade before the ban, hospital admissions for heart attacks had dropped by about 3 percent per year."


Action on Smoking and Health (ASH - U.S.): "Now a number of major studies – in Helena [MO], Pueblo [CO], New York State, Piedmont [Italy], Ireland, and Scotland – have consistently shown a major decrease in hospital admissions for heart attacks after smokefree laws went into effect."

ClearWay Minnesota: "Smoking ban brings big cut in heart attacks in Scotland, study finds."

Henry Ford Health System: "If Michigan were to implement a comprehensive smoking ban tomorrow, we would see a 12 percent drop in heart attack admissions after the first year," says Mouaz Al-Mallah, M.D., Henry Ford's director of Cardiac Imaging Research and lead author of the study."

ASH UK: "A study of nine Scottish hospitals has found a 17 per cent fall in admissions for heart attacks in the first year after the smoking ban came into force."

ASH Scotland: "A study of nine Scottish hospitals has found a 17 per cent fall in admissions for heart attacks in the first year after the smoking ban came into force. The research is part of a national evaluation of the impact of Scotland's smoke-free legislation which shows that the smoking ban has had an overwhelmingly positive effect. The evaluation found that after the legislation came into force there was: a 17 per cent reduction in heart attack admissions to nine Scottish hospitals. This compares with an annual reduction in Scottish admissions for heart attack of 3 per cent per year in the decade before the ban."

Healthier Scotland: "Evaluation of the smoke-free legislation has so far found: ... reduced cases of myocardial infarction and reduced hospital admissions for acute heart attack."

ASH Scotland: "A 17% fall in admissions for heart attacks in the first year after the smoking ban came into force compared with 3% in preceding years."

ASH Australia: "A study in the prestigious New England Journal of Medicine provides strong new evidence that laws requiring smokefree workplaces have a rapid and significant impact on health. The study found that after smokefree legal changes in Scotland there was a 17% fall in hospital admissions for acute heart attacks - and two-thirds of the improvement was among non-smokers. ... Several other studies have demonstrated reductions in coronary events in the wake of smoke-free laws. However, the Scottish study is particularly strong because it used larger samples, examined the effect among non-smokers and smokers, included measures of exposure to secondhand smoke, and included a strong geographic control."

Medical Research Council (UK): "The effect of the Scotland ban has been quantified in the first year after the smoking ban has come into force. There has been a 17 per cent fall in admissions for heart attacks, which compares with an annual reduction in Scottish admissions for heart attack of 3 per cent per year in the decade before the ban."

Health Scotland: "17% reduction in heart attack admitted to 9 major Scottish hospitals. Average reduction of 3% per year in Scottish heart attack admissions in the 10 years leading up to the ban."

Office of the Chief Medical Examiner (Scotland): "Heart attack admission rates fell at an average rate of 3.8% per year in the ten years before the smoke-free legislation. For the six months following the implementation of the legislation the annual rate of decline increased by more than six-fold to 25% 11. A separate study of people admitted to coronary care units in 9 major Scottish hospitals found a 17% fall in admissions in the 10 months after the legislation compared with the corresponding 10 months in the preceding year, with a larger reduction among non-smokers."

Chartered Institute of Environmental Health (Wales): "Early research findings from Scotland, where smoke-free legislation came into force in March 2006, have been extremely positive. These include a 17 per cent reduction in heart attack admissions...".

Smoke Free Action (UK): "Recently released research from Scotland shows that admissions to hospital for heart attacks have declined by 17 per cent since the introduction of the smoking ban in public places."

British Heart Foundation: "A study of nine Scottish hospitals has found a 17% fall in admissions for heart attacks during the first year of the smoking ban. This compares with an annual reduction in Scottish admissions for heart attacks of 3% per year in the decade before legislation to ban smoking in public places."

Smokefree Philly: "A new study from Scotland provides what public-health experts in the U.S. say is the strongest evidence yet that public bans on smoking improve health."

Monday, December 01, 2008

Data Released by Scottish National Health Service Show that Conclusions of Earlier Study about Effect of Smoking Ban on Heart Attacks Were Wrong

Data from the Scottish National Health Service on hospital admissions for heart attacks and unstable angina (acute coronary syndrome) obtained and released by Christopher Snowdon over at Velvet Glove Iron Fist reveal that admissions for acute coronary syndrome rose sharply during the second year of the smoking ban, such that there was little overall change over the first two years during which the smoking ban has been in effect.

This demonstrates that the decline in acute coronary syndrome admissions observed during the first year after the smoking ban was not due to the ban, but was simply a reflection of underlying variation in the data -- it is apparent now that the decline was just a blip down and the admissions have now climbed back up to where they were prior to the smoking ban.

As Snowdon writes: "Much was made of an apparent reduction in the number of patients being diagnosed with the life-threatening heart condition after the smoking ban came into effect in 2006, including a study published in the New England Journal of Medicine which claimed that the ban had caused emergency ACS [acute coronary sydrome] admissions to fall by 17%."

"However, official statistics show that the decline in hospitals admissions for acute coronary syndrome has been greatly exaggerated. The real decline in the first year of the smoking ban was just 7.2% - not 17% - and the rate then rose by 7.8% in the second year, cancelling out the earlier drop."

"In the last 12 months before Scotland enacted its smoking ban (April 05 to March 06) there were 16,199 admissions for acute coronary syndrome*. In the second year of the smoking ban (April 07 to March 08) there were 16,212 admissions, slightly more than there had been before the legislation was enacted." ...

"Hospital admissions for acute coronary syndrome have been declining in Scotland for many years. The new data show that the well-publicised fall in admissions following Scotland's smoke-free legislation was in line with the existing downward trend and was significantly less steep than has previously been claimed."

"The belief that the number of cases of acute coronary syndrome fell by 17% after the smoking ban stems from a study of volunteers in a selection of Scottish hospitals between 2005 and 2007. The study - 'Smoke-free Legislation and Hospitalizations for Acute Coronary Syndrome' - has since been criticised for its limited scope and for excluding data from several key months before and after the ban."

"If the 2006-07 decline had really been the result of the smoke-free legislation, it would be expected for rates to remain low in subsequent years. The fact that Scottish hospitals have seen an unusually sharp rise - despite the smoking ban being rigorously enforced - suggests that whatever lay behind the 2006-07 dip, it was not the smoking ban."

The Whole Story

In September 2007, the University of Glasgow issued a press release announcing a new study which concluded that the smoking ban in Scotland had resulted in a 17% decline in heart attack admissions during the first year in which the smoking ban was in effect. The University of Glasgow is the home of the lead researcher on the study: Dr. Jill Pell. The study itself was not made available. However, its conclusions were blasted throughout the world via the media.

For example, in an uncritical recounting of the data and conclusions in the press release, Spiegel wrote as follows:

"it seems a miracle has happened: The number of heart attacks in Scotland has suddenly dropped by no less than 17 percent in a single year. What has happened? Have the Scots stopped eating red meat? Has the whole country started knocking back cholesterol medication? Are they all training for the marathon? No. The reason is much simpler: Scots are having fewer heart attacks because they are no longer inhaling other people's cigarette smoke when they sit in the pub, the train or the office."

According to the press release: "A University of Glasgow study has found a 17 per cent fall in admissions for heart attacks in the first year after the smoking ban came into force. The evaluation, led by Professor Jill Pell from the University’s BHF Cardiovascular Research Centre, found that after the legislation came into force there was a 17 per cent reduction in heart attack admissions to the hospitals. This compares with an annual reduction in Scottish admissions for heart attack of 3 per cent per year in the decade before the ban."

At the time, I criticized the study for two reasons. First, I argued that the release of the study via a press release represented a "science by press release" approach that was not appropriate, because study conclusions should not be disseminated through the media until after they have undergone peer review and the study has been published, or at least until researchers are willing to make the entire study and its methodology available so that it can be reviewed by others.

I also criticized the study conclusions because it was not clear that the reported decline in heart attacks was not simply random variation and/or an existing secular decline in heart attacks that was occurring anyway, even without the smoking ban.

I noted: "To see why a thorough review of the actual study is necessary, just look at the hospital discharge data for heart attacks in Scotland. We find evidence of a large single-year decline in heart attacks of about 10% which occurred in the absence of any smoking ban. This indicates that there can be a large year-to-year variation in heart attacks in Scotland and makes it especially difficult to determine whether a 17% annual decline in heart attacks is due in part to random variation, and if so, to what extent. From the information that was provided to us, it is impossible to conclude that the smoking ban was responsible for the observed decline in heart attack admissions.

It is also important to consider the fact that the more rapid decline in heart attack admissions in Scotland appears to have begun prior to the smoking ban. A drop in heart attack admissions of 17% (equal to what was observed after the smoking ban) actually occurred during the three-month period immediately prior to the smoking ban. It would be very questionable to attribute the observed heart attack decline to the smoking ban in the face of this evidence that heart attacks were declining substantially prior to the ban. It is entirely possible that some other factor is responsible for the observed decline."

Importantly, about two months after the initial press release, I discussed data, reported in an article by Michael Blastland published by the BBC News, that were released by the National Health Service's Informational Services Division. These data included all hospital admissions for heart attacks nationwide in Scotland, reported as annual standardized rates. The data showed a decline of about 8% in the year following the smoking ban, which is only slightly higher than the approximate 6% decline the year preceding the smoking ban. If one looked at the trend in heart attack rates from 1998 through 2007, one would find that based on the pre-existing trends in heart attack rates, there had been no apparent change in the rate of heart attacks following the smoking ban, which was implemented in March 2006.

In addition, these data confirmed an earlier analysis, in which I pointed out that a huge decline in heart attacks in Scotland from 1999 to 2000 occurred prior to the smoking ban and revealed the large degree of baseline variability in the data, meaning that only a junk science study would conclude that the observed decline in heart attacks during the 10 months following the smoking ban was attributable to the smoking ban. In fact, the data revealed that the largest drop in heart attack admission rates occurred not following the smoking ban, but from 1999 to 2000.

Despite the shoddy nature of the study's conclusions and the unsupporting data coming from a national, population-based database, the authors proceeded to publish their study in the New England Journal of Medicine in July, 2008. The study concluded 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.

I immediately argued that: "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)." I argued that this is comparing apples to oranges, and it is not valid science.

In September 2008, Christopher Snowdon over at Velvet Glove Iron Fist reported that the results and conclusions of the Pell et al. study were wrong. Snowdon's article was based on a complete data set of acute coronary syndrome admissions in all of Scotland for the entire period from 1999 through 2007. He included data for the full two years following the smoking ban and for at least seven years preceding the ban. Snowdon found that contrary to the results reported by Pell et al., acute coronary syndrome admissions fell by just 9.3% in the year following the ban (compared to the year preceding the ban). But more importantly, this decline was no greater than that observed several times during the baseline period. For example: "AMI [acute myocardial infarction] admissions fell by 10.2% in 1999-2000 and angina admissions fell by 10.5% in 2005-2006 (there were also falls of 11.6%, 11% and 12% in previous years)."

Moreover, when one examined the full data, one saw that while there was a decline in acute coronary syndrome admissions in Scotland following the smoking ban, this decline was not as steep as it had been prior to the smoking ban. In other words, the rate of decline in acute coronary syndrome admissions actually decreased after the smoking ban.

Now, the data obtained by Christopher Snowdon reveal that what happened in Scotland was the opposite of what the researchers reported. Rather than to create an acceleration in the existing rate of decline in acute coronary syndrome admissions, the implementation of the smoking ban was associated with a decrease in the rate of decline. In fact, in the two years that the smoking ban has been in effect, the trend of declining acute coronary syndrome admissions in Scotland has ground to a halt.

This does not, of course, mean that the smoking ban resulted in an increase in heart attacks. It simply demonstrates that the observed decline in acute coronary syndrome admissions was a statistical blip. Data tends to zig and zag just from normal random variation. If you catch the data when it is zagging, you might inadvertently conclude that heart attacks are dropping, unless you stick around long enough to see that the next year, the heart attack rate zigs.

The zigging and zagging of statistical data is normal. What science must do is to account for this zigging and zagging and refrain from drawing conclusions about changes in data until the underlying zigging and zagging has been accounted for. This is what the authors of the Scottish smoking ban study failed to do.

And now, the most complete data yet assembled show that the conclusion of their New England Journal of Medicine study was wrong: the smoking ban in Scotland did not cause a substantial, immediate drop in heart attacks or acute coronary syndrome.

The Rest of the Story

There are three important parts to the rest of the story.

First, this story demonstrates the dangers of science by press release. The conclusions from the Scotland smoking ban study have already been disseminated widely to the public and it is far too late to retract them. Even if the researchers were to issue a media advisory in which they noted that their conclusion has been disproved, it is unlikely that it would pick up enough media attention to undo the publicity created by the initial media coverage.

Second, this story demonstrates the significant bias inherent in research by the anti-smoking movement these days. This bias is so strong that researchers can apparently not wait until they have sufficient data to draw a reasonable conclusion. The desired conclusion has to be disseminated widely when it is still preliminary in order to create a media splash that cannot be reversed if the conclusions subsequently prove to be wrong.

Third, this story demonstrates that the anti-smoking movement does not really care about the truth: it cares mostly about producing favorable evidence to support its conclusions. When the original studies came out (both the unpublished study and the published article), anti-smoking groups issued press releases and did everything they could to generate media attention about the study conclusions. Now that these conclusions have proven to be wrong, anti-smoking groups are not publicizing the error of the study. They are not issuing press releases to report these new data and to update the public with the accurate conclusion of the study. Nor are they going to do so.

I will go through the usual motions of disseminating my commentary throughout the movement, to all the key groups which have issued what turns out to be false, preliminary conclusions. But these groups are not going to do anything to correct the damage that has been done through the dissemination of these inaccurate conclusions.

You see - it doesn't really matter anyway. This is the tobacco control movement and since it is all for a good cause, there really isn't damage done by disseminating false scientific conclusions. Thus, it doesn't need to be corrected. After all, this is no longer about scientific accuracy or scientific integrity. This isn't about the truth. It's about producing favorable evidence to support the policy agenda of the anti-smoking movement.

Wednesday, February 15, 2012

Rhode Island Study Shows No Effect of Smoking Ban on Heart Attacks, But Reports that Ban Caused a 28% Drop

A new study from the Rhode Island Department of Health has concluded that the smoking ban, implemented in Rhode Island in March 2005, resulted in a 28% drop in heart attack admissions in the state (see press release).

The study examined age-adjusted rates of admission for acute myocardial infarction in all Rhode Island hospitals from 2003 to 2009. The report compares the hospitalization rates in 2003 and 2004 (prior to the smoking ban) with those in 2006 through 2009 (the four complete calendar years following the smoking ban).

According to the press release: "The findings reveal a 28.4 percent drop in the rate of acute myocardial infarction (AMI) admissions and a 14.6 percent reduction in total associated cost, representing a potential savings of over six million dollars."

The study also examined changes in hospital admission rates for asthma and appendicitis. Asthma was chosen because it is also related to secondhand smoke. Appendicitis was chosen as a control condition because it is not related to secondhand smoke exposure.

The study results were as follows: "The largest reduction in AMI hospitalization rates was seen between 2003, when the rate was 35.2 per 10,000 population (95% CI 34.0 – 36.5), and 2009, when the rate was 23.1 per 10, 000 population (95% CI 22.1 – 24.1), a full four years after the ban prohibiting smoking in public places took effect. There was a significant increase in hospitalization rates for asthma between 2003 (11.3; 95% CI 10.6 – 12.1 and 2009 (13.5; 95% CI 12.8 – 14.3), but no change in the hospitalization rate for appendicitis over this time period (2003: 7.9; 95% CI 7.3 – 8.5; 2009: 8.5; 95% CI 7.9 – 9.1)."

The study then concludes: "Our study showed a reduction in age-adjusted hospitalization rates for AMI after the implementation of a statewide comprehensive ban on indoor smoking, with a 17% reduction in AMI-specific hospitalization rates in the first post-statewide ban period (2006-2007). A strength of this study is that we assessed the potential effects of the ban in the two years immediately following its implementation and at one later time point, which showed sustained decreases in AMI hospitalization rates and associated costs."

The media are now reporting that Rhode Island's smoking ban led to a huge decline in heart attack admissions.

The Rest of the Story

The rest of the story is that the actual study data show that the heart attack admissions rate in Rhode Island was declining significantly prior to the smoking ban. The analysis fails to take this into account, because rather than examine the significance of the difference between the rate of decline in heart attacks after the ban and the rate of decline prior to the ban, it merely compares the absolute rates of admissions before and after the ban. Thus, it does not control for the baseline, pre-existing trend of a huge secular decline in heart attacks observed in Rhode Island during the years immediately preceding the implementation of the smoking ban.

In other words, while the study finds a 28% decline in heart attacks, what percentage decline in heart attacks would one have expected in the absence of the smoking ban? The best answer to that question comes from examining the baseline data. Unfortunately, the paper only goes back two years before the smoking ban so the only years that can be used to estimate the rate of decline in heart attacks prior to the smoking ban are the 2003 and 2004 data points. Nevertheless, these are the data that must be used.

Here is what you'll find if you examine the actual difference in the observed average annual rate of decline in heart attacks before and after the smoking ban:

Before Ban: 10.5% per year
After Ban: 5.3% per year

In other words, the actual data show a deceleration, or a decrease, in the rate of decline in heart attacks in Rhode Island in the years following the smoking ban.

The figure below plots the actual data.



It is clear from the graph that the rate of decline in heart attacks decelerated somewhat after the smoking ban. Had the decline continued following the baseline trend, the expected heart attack rate in 2009 would have been 18.1, instead of the observed rate of 23.1.

One of the major problems with this study is that it does not examine enough pre-smoking ban data to reliably establish the baseline trend in heart attacks. But given the data that is available, one is forced to conclude that there was a deceleration in the rate of decline in heart attacks.

The rate of decline in heart attacks in the year prior to the smoking ban (10.5%) is larger than the year-to-year decline in heart attacks for any period following the smoking ban. In fact, from 2007 to 2008, there was actually a slight increase in the heart attack rate. Given these data, it is difficult to see how the paper could conclude that the smoking ban resulted in a 28% decline in heart attacks.

More troubling, perhaps, is the way the paper dismisses the failure to find a decline in asthma admissions following the smoking ban. On the contrary to what one might have expected, the study reports an increase in asthma admissions. Since the study concluded that the observed changes in heart attacks were attributable to the smoking ban (and does not consider any other factors), must not the paper also conclude that the changes in asthma attack admissions were also attributable to the smoking ban?

Instead of using the same reasoning it used to attribute changes in heart attacks to the smoking ban, the paper dismisses this "adverse" result and explains it away based on conjecture about changes in the economy: "The severity of the recent economic crisis in Rhode Island likely amplified factors associated with asthma exacerbations, such as poverty and poor housing quality. These factors may have contributed to the increase in hospital admissions for asthma."

Unfortunately, this has the appearance of accepting as a causal relationship any favorable changes following a smoking ban, but rejecting a causal link for any unfavorable changes following the smoking ban. In other words, the research appears to be heavily biased in the direction of interpreting results in order to be able to report favorable findings and not having to report any unfavorable findings.

To be clear, I am not arguing that the smoking ban resulted in an increase in asthma. Nor am I arguing that the smoking ban resulted in an increase in heart attacks. What I am arguing is that based on the data presented in the paper, there is no way the article can conclude that the Rhode Island smoking ban was associated with a 28% decline in heart attack admissions in the state.

In order to make any causal attributions at all, one would first have to extend the baseline back at least four to five more years to get an accurate picture of the baseline trends in heart attacks and asthma rates prior to the smoking ban.

While I strongly agree with the paper's recommendation that other states "join the growing list of 35 U.S. states benefiting from smoke-free laws," my support for such policies is not based on the finding that the Rhode Island smoking ban decreased heart attacks by 28%. While we all want to see a positive and immediate effect of these policies on severe morbidity, being scientifically rigorous is still important and it does not help the cause in the long run to draw conclusions that are unsupported by the data. There are enough reasons for policy makers to enact smoking bans. There is no need for us to try to artificially manufacture findings that are unsupported by the data.

Thursday, September 27, 2007

The Dangers of Science by Press Release: Putative Effects of Scottish Smoking Ban on Heart Attacks Gets Widespread, Uncritical Media Coverage

An article published earlier this week in Spiegel Online informs the public that the smoking ban in Scotland resulted in a dramatic 17% decline in heart attacks during the first ten months that the ban was in effect. According to the Spiegel article, there were 551 heart attacks that failed to occur due to the smoking ban.

The article is based on unpublished data released via a press release by the University of Glasgow, home of the lead researcher on the study. To the best of my knowledge, the study itself is not easily available for public scrutiny.

In an uncritical recounting of the data and conclusions in the press release, Spiegel writes as follows:

"it seems a miracle has happened: The number of heart attacks in Scotland has suddenly dropped by no less than 17 percent in a single year. What has happened? Have the Scots stopped eating red meat? Has the whole country started knocking back cholesterol medication? Are they all training for the marathon? No. The reason is much simpler: Scots are having fewer heart attacks because they are no longer inhaling other people's cigarette smoke when they sit in the pub, the train or the office. Scientists at the University of Glasgow reported last week that things have become remarkably quiet in the country's heart clinics since smoking in public was banned in Scotland in March 2006. In nine selected Scottish clinics, 3,235 heart attack victims were brought in during the 10 months before the ban. In comparison, the number for the 10 months after the ban was only 2,684. Now the Scots and the rest of the world are marvelling at 551 heart attacks that never happened -- simply because of cleaner air."

The Rest of the Story

While Spiegel Online may be reporting that there were 551 fewer heart attacks in Scotland due to the smoking ban, Siegel Online is reporting that this conclusion is far too premature, and that the simple fact that there was a reduction in heart attacks from one year to the next is not sufficient evidence to conclude that this reduction is attributable to the implementation of the smoking ban.

In fact, I presented evidence that a 17% drop in heart attack admissions occurred in the 3 months prior to the smoking ban -- obviously, that much more drastic decline in heart attacks was not attributable to the smoking ban. Clearly, it is premature to jump to these conclusions.

This story demonstrates the danger of the science by press release approach. This is precisely why it is not prudent to issue findings that have not been validated by a peer review process. Suppose that upon peer review, it turns out that the study findings are unwarranted and invalid. Are the researchers going to then issue a press release stating that they were wrong, that their conclusion was premature and invalid, and that all news articles that the public throughout the world read to the contrary should be disregarded?

I highly doubt it.

Should these findings be invalidated based on peer review, it will at this point be inconsequential. The point is that the word is already out there. The conclusions have already been disseminated. It is too late to retract them if they are indeed wrong.

I view it to be inappropriate and perhaps unethical to release the results of a scientific study prior to peer review and publication. There is one exception, and that is IF (and only if) one makes the study available for public scrutiny and review. If you are going to go to the press to disseminate study findings, then you have to be willing to allow the public to see the study upon which those findings are based. Otherwise, there is no opportunity for review and scrutiny of your work.

To see how science by press release subverts scientific integrity, suppose that RJ Reynolds were to come out with a press release stating that Camel No. 9 cigarettes were found to reduce cancer risk by 20%. Newspaper headlines widely carried the headlines that Reynolds has produced a safer cigarette.

The first thing that anti-smoking groups would want to know is whether or not this research had been peer-reviewed and published. Suppose that it had not, and that the company did not release the study upon which these conclusions were based. There is no doubt that anti-smoking groups would condemn RJ Reynolds, question the validity of the study results, and claim that the company was widely misleading the public. RJ Reynolds would be attacked for violating established scientific standards.

Well if those standards apply to RJ Reynolds, then why don't they also apply to research which draws conclusions that are "favorable" to the anti-smoking cause?

Are we no longer required to adhere to solid scientific practice in tobacco control?

Apparently, we are not. Somehow, I must have missed that memo.

Friday, December 24, 2010

Finalists for 2010 Lie of the Year Award Announced; Winners to Be Announced Next Week; Merry Christmas to All; Back Next Week

Today I am announcing the finalists for the 2010 Lie of the Year Award, which will be given to the anti-smoking group which disseminated the most egregious lie during 2010. Unfortunately, there are a lot of very strong contenders for this year's award.

The quarter-finalists, semi-finalists, finalists, and winner will be announced over the course of next week, with the final winner announced just before New Year's Day. Feel free to vote for your top choices. Reader opinions will be taken into account in determining the winners.

I wish a Merry Christmas and happy holidays to all of my readers!

The Finalists

1. Free & Clear

The Lie: "Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.”"

The Rest of the Story: What Free & Clear does not tell the consumer is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

2. United States Surgeon General's Office

The Lie: (1) "Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack."; (2) "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The Rest of the Story: It is simply not true that even brief exposure to secondhand smoke can cause cardiovascular disease. Luckily, it takes many years of exposure before the process of atherosclerosis (hardening of the arteries) can occur. Fortunately as well, inhaling the smallest amount of tobacco smoke does not lead to cancer. While the Surgeon General is correct in asserting that the tiniest amount of tobacco smoke can damage your DNA, it simply is not true that someone who inhales the tiniest amount of tobacco smoke may well develop cancer because of it. There is certainly no evidence to support such a statement.

3. Americans for Nonsmokers' Rights

The Lie: (1) "there are virtually no health disparities between active and passive smoking."; (2) "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."; (3) "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story: ANR's claim that there are virtually no health disparities between active and passive smoking is a lie. If ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe. How can ANR can claim that there are virtually no health disparities between active and passive smoking? That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers. If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false.

The statement that brief exposure to secondhand smoke causes heart damage in nonsmokers similar to that observed in active smokers is also a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack. Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage. ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is.

4. Kentucky Center for Smoke-Free Policy, University of Kentucky College of Nursing

The Lie: "Even brief exposure to secondhand smoke can trigger a heart attack. ... In 20-30 minutes, fat and blood clots build up in the arteries, increasing the chance of heart attacks and stroke. After 2 hours of secondhand smoke exposure, the heart rate speeds up and leads to abnormal heart rhythms (which can lead to death)."

The Rest of the Story: Both of these statements are outright lies. You don't get a build up of fat and blood clots in the arteries in just 30 minutes. What happens in 30 minutes is that the cells lining your coronary blood vessels do not function normally, leading to a reduction in coronary flow velocity reserve. This damage to the blood vessel lining is reversible. However, if repeated over and over again and sustained for many years, these effects could contribute to the formation of atherosclerosis (hardening of the arteries). But it is a lie to state that 30 minutes of tobacco smoke exposure results in a build up of fat and blood clots in the arteries that increases the chance of a heart attack or stroke.

It is also untrue that 2 hours of exposure to secondhand smoke causes potentially catastrophic cardiac arrhythmias. What short-term tobacco smoke exposure can do is reduce heart rate variability. This is an important finding in that it provides biologic plausibility for the finding of a relationship between chronic secondhand smoke exposure and heart disease, but it does not mean that an individual exposed to tobacco smoke for 2 hours is at increased risk of dying of a cardiac arrhythmia.

5. Florida Department of Health

The Lie: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

6. Maricopa County Department of Public Health

The Lie: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure. Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

7. Breathe California of Sacramento-Emigrant Trails

The Lie: "Smoking kills about 340 young people a day."

The Rest of the Story: According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.

8. FDA Center for Tobacco Products

The Lie: "research has found that children are especially attracted to and begin using tobacco products very early because of all kinds of pressures and motivations, including access to cigarettes that have candy-like characterizing flavors, such as mint, chocolate, cinnamon, coconut, and strawberry."

The Rest of the Story: If mint, chocolate, cinnamon, coconut, and strawberry cigarettes are a major reason for youth smoking, I challenge the Center for Tobacco Products to name a single brand of mint, chocolate, cinnamon, coconut, or strawberry cigarettes that was smoked by a significant number of youth during the past four years. The only existing brands of cigarettes in those flavors that I am aware of were marketed by R.J. Reynolds for a brief period from 2004 to 2006, but were voluntarily removed from the market in 2006. Thus, mint, chocolate, cinnamon, coconut, and strawberry cigarettes play no role in youth smoking initiation and the Family Smoking Prevention and Tobacco Control Act's prohibition of these flavors has removed none of these flavored cigarette brands from the market and has had no effect whatsoever on youth cigarette smoking.

9. FDA and U.S. Department of Health and Human Services

The Lie: "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers."; "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The Rest of the Story: It is demonstrably false that flavored cigarettes are a gateway to cigarette smoking, that they contribute significantly to addiction of youths to tobacco, that the tobacco industry uses these flavored cigarettes to hook children, and that the FDA ban on candy-flavored cigarettes will have any impact whatsoever on youth smoking. (This is with the exception of menthol, the one flavoring which is actually used by the tobacco companies to hook kids, but which is exempt from the flavoring ban.) In fact, prior to the implementation of the law, not a single flavored cigarette brand (other than menthol cigarettes) produced by one of the major tobacco companies - including Philip Morris, Reynolds American, or Lorillard - was on the market. And the overall market share of flavored cigarettes among youth smokers was less than 0.1%. The truth is that nearly every youth who is addicted to tobacco smokes one of the major cigarette brands - including Marlboro, Camel, Newport, Kool, Winston, Parliament, and Basic. None of these are flavored cigarettes (again, with the exception of menthol, which I'll get to shortly). The truth is that the predominant gateway to youth smoking is non-flavored cigarettes (excluding menthol). The removal of flavored cigarettes from the market by the FDA will have no impact whatsoever on youth smoking. The only thing that would have had an impact is the removal of the non-flavored cigarettes - like Camels, Marlboros, and Newports - which are smoked by greater than 85% of all youth smokers.

10. American Cancer Society

The Lie: "The American Cancer Society, along with the broader public health community, fought the tobacco industry for more than a decade to get this historic legislation passed."

The Rest of the Story: The statement is simply not true. The biggest supporter of the FDA tobacco legislation, and a contributor of enormous lobbying expenditures in support of the bill, was none other than Philip Morris, the nation's largest tobacco company. Why does the American Cancer Society have to continue to lie like this? Why are they seemingly incapable of telling the American people the truth: that Philip Morris supported this bill?

Monday, December 27, 2010

Quarterfinalists for 2010 Tobacco Control "Lie of the Year Award"

Here are the 8 quarterfinalists for the 2010 Tobacco Control Lie of the Year Award:

1. Free & Clear


The Lie: "Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.”"

The Rest of the Story: What Free & Clear does not tell the consumer is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

2. United States Surgeon General's Office

The Lie: (1) "Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack."; (2) "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The Rest of the Story: It is simply not true that even brief exposure to secondhand smoke can cause cardiovascular disease. Luckily, it takes many years of exposure before the process of atherosclerosis (hardening of the arteries) can occur. Fortunately as well, inhaling the smallest amount of tobacco smoke does not lead to cancer. While the Surgeon General is correct in asserting that the tiniest amount of tobacco smoke can damage your DNA, it simply is not true that someone who inhales the tiniest amount of tobacco smoke may well develop cancer because of it. There is certainly no evidence to support such a statement.

3. Americans for Nonsmokers' Rights

The Lie: (1) "there are virtually no health disparities between active and passive smoking."; (2) "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."; (3) "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story: ANR's claim that there are virtually no health disparities between active and passive smoking is a lie. If ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe. How can ANR can claim that there are virtually no health disparities between active and passive smoking? That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers. If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false.

The statement that brief exposure to secondhand smoke causes heart damage in nonsmokers similar to that observed in active smokers is also a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack. Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage. ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is.

4. Florida Department of Health

The Lie: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

5. Maricopa County Department of Public Health

The Lie: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure. Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

6. Breathe California of Sacramento-Emigrant Trails

The Lie: "Smoking kills about 340 young people a day."

The Rest of the Story: According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.

7. FDA and U.S. Department of Health and Human Services

The Lie: "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers."; "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The Rest of the Story: It is demonstrably false that flavored cigarettes are a gateway to cigarette smoking, that they contribute significantly to addiction of youths to tobacco, that the tobacco industry uses these flavored cigarettes to hook children, and that the FDA ban on candy-flavored cigarettes will have any impact whatsoever on youth smoking. (This is with the exception of menthol, the one flavoring which is actually used by the tobacco companies to hook kids, but which is exempt from the flavoring ban.) In fact, prior to the implementation of the law, not a single flavored cigarette brand (other than menthol cigarettes) produced by one of the major tobacco companies - including Philip Morris, Reynolds American, or Lorillard - was on the market. And the overall market share of flavored cigarettes among youth smokers was less than 0.1%. The truth is that nearly every youth who is addicted to tobacco smokes one of the major cigarette brands - including Marlboro, Camel, Newport, Kool, Winston, Parliament, and Basic. None of these are flavored cigarettes (again, with the exception of menthol, which I'll get to shortly). The truth is that the predominant gateway to youth smoking is non-flavored cigarettes (excluding menthol). The removal of flavored cigarettes from the market by the FDA will have no impact whatsoever on youth smoking. The only thing that would have had an impact is the removal of the non-flavored cigarettes - like Camels, Marlboros, and Newports - which are smoked by greater than 85% of all youth smokers.

8. American Cancer Society

The Lie: "The American Cancer Society, along with the broader public health community, fought the tobacco industry for more than a decade to get this historic legislation passed."

The Rest of the Story: The statement is simply not true. The biggest supporter of the FDA tobacco legislation, and a contributor of enormous lobbying expenditures in support of the bill, was none other than Philip Morris, the nation's largest tobacco company. Why does the American Cancer Society have to continue to lie like this? Why are they seemingly incapable of telling the American people the truth: that Philip Morris supported this bill?