Thursday, 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.

Wednesday, July 30, 2008

My Letter to the Editor Criticizes Treatment of Smoking as a Moral Issue

On July 14, I reported on an article in the Daily Freeman (Kingston, NY), a Dutchess County legislative leader is promoting a smoking ban for all county parks and their parking lots because smoking sets a bad example for children. A similar law being considered in neighboring Ulster County would ban smoking on all county-owned property.

According to the article: "''I just feel there shouldn't be tobacco use in county parks,' said Dutchess County Legislature Majority Leader Sandra Goldberg, who led the Dutchess initiative. Goldberg, D-Wappinger, said the county's parks are intended to be a "family place" and the presence of smokers is not only harmful to those forced to breathe second-hand smoke, but it sets a bad example for children. Nearly the entire Democratic caucus in the county Legislature supports the Dutchess measure, Goldberg said."

This trend of promoting widespread outdoor smoking bans not to protect nonsmokers from secondhand smoke but to protect nonsmokers from seeing smokers is picking up momentum; yesterday, I reported the implementation of an ordinance in Loma Linda, California which explicitly states its intention is to prevent children from having to see smokers and thus make the city a family-unfriendly place.

The Rest of the Story

In response to this trend and in particular, to the Daily Freeman article, I submitted a letter to the editor which was published in the Daily Freeman on July 22 (page A5).

The newspaper does not appear to publish its letters to the editor online, but here are some excerpts from my letter:

"You reported (July 13) that a Dutchess County legislative leader is promoting a smoking ban for all county parks and their parking lots because smoking sets a bad example fro children.

According to the article, "Dutchess County Legislature Majority Leader Sandra Goldberg, who led the Dutchess initiative ... said the county's parks are intended to be a 'family place' and the presence of smokers is not only harmful to those forced to breath secondhand smoke, but it sets a bad example for children."

We will be in serious trouble when we start outlawing health behaviors in public merely because they set a bad example. Are we going to outlaw eating french fries in public because it sets a bad example to children regarding a healthy diet? Are we going to outlaw severely overweight people from public parks because they set a bad example for children? ...

The danger here is that Goldberg is turning smoking into a moral, rather than strictly a health issue. It is crossing that line from health into morals, with regard to smoking or any other health behavior, that I find unacceptable, inappropriate, and, frankly, dangerous. ...

To argue that smoking needs to be banned on all county property because we need to protect kids from seeing this morally inappropriate behavior is no longer a public health argument. It is a public morality argument and it has no place in this debate."

Tuesday, July 29, 2008

Ban on Smoking Just About Everywhere Outdoors in Loma Linda Goes Into Effect

Last Friday, what is perhaps the nation's most restrictive smoking ban went into effect in the city of Loma Linda, California. The ordinance, adopted by the City Council on June 24, bans smoking practically everywhere outdoors in the city, with the exception of private residential property and outdoors smoking outposts at shopping centers.

Other than private residential property or approved smoking areas at shopping centers, the ordinance bans smoking in every outdoor area in the entire city. The only exception is a privately owned outdoor area if no nonsmoker is present and "due to the time of day or other factors, it is not reasonable to expect another person to arrive." On publicly owned property, there is no smoking outdoors allowed, without exception.

This means that there is no smoking in any street, in any alleyway, on any sidewalk, in any public parking lot, or anywhere else outdoors in Loma Linda, unless it is private property and there is no expectation of another person arriving (which amounts to a ban on smoking except in the wee hours of the night).

The Rest of the Story

Before getting to the draconian nature of this law, I need to comment on the hypocrisy of the Loma Linda City Council (other than the one councilor who voted against the ordinance).

The city council declared that it needed to ban smoking everywhere in the city, even in remote outdoor locations where no nonsmoker was present, because in its own words, it desired to:
  1. protect children from exposure to smoking and tobacco;
  2. reduce the potential for children to associate smoking and tobacco with a healthy lifestyle; and
  3. affirm and promote the family-friendly atmosphere of the City’s public places."
In other words, the city council believed that public smoking is such an affront to the public atmosphere that it needed to ban public smoking so that children wouldn't see any smokers.

Well ... if smoking is such an affront to the family-friendly atmosphere of the city, then why was there a need to allow smoking in what are probably the two places that are most crowded and where children are most likely to see smokers: the Loma Linda Plaza Shopping Center and Mountain View Plaza Shopping Center?

I think the answer is obvious: because the city council has no integrity or willingness to stand up for a principle, especially when it perceives that standing up for that principle may interfere with the money that the city brings in.

Ironically, if you are in a remote public alleyway with no person present within hundreds of feet, you cannot smoke; however, if you are at a crowded shopping plaza with hundreds of children and families milling around, you are allowed to smoke in a designated area.

Interestingly, city councilors determined that smoking is a bad influence on children in all public places in the city with the exception of shopping centers.

One other comment before I get to the draconian nature of this law. I reject the city council's three justifications for this ordinance's prohibition of smoking in virtually all outdoors areas of the city. I don't think that preventing children from seeing smokers is a valid justification for a smoking ban. I think the reason to enact smoking bans is to protect nonsmokers from secondhand smoke exposure.

The same justification that the city council used to ban smoking in virtually all outdoors locations could also be used to ban the consumption of fatty foods in public, or even to ban obese people from public places.

This is why I find the ordinance to be draconian in nature: because it goes beyond the desire to protect nonsmokers from secondhand smoke exposure. There is clearly no need to ban smoking in every outdoor location in a city in order to protect nonsmokers from the hazards of tobacco smoke exposure. Banning smoking on every street and in every sidewalk, alley and parking lot is simply not justified by any science which demonstrates that exposure to secondhand smoke in these locations represents a significant public health problem.

Even worse, by banning smoking virtually everywhere outdoors, this ordinance might just succeed in pushing smokers to where they city apparently wants them: indoors. And with that comes an even worse public health problem than this ordinance is intended to solve -- exposure of children to secondhand smoke in the home.

What the city is basically saying is that if you are a smoker, we don't want to see you smoking outside. Keep it inside, where you can expose your children to the smoke in the privacy of your own home.

Is it really better for smokers to expose their children to secondhand smoke than to smoke in outdoors locations where their children are not exposed, but people might see them smoking?

The penalties in the ordinance for failure to enforce its provisions are also draconian, in my opinion. According to this ordinance, if you own a hardware store and a guy is smoking in a remote area of your parking lot, with no one within sight, you are guilty of violating this ordinance if you don't accost him and stop him from smoking. Does that really make any sense?

It's interesting to me how the goalposts have changed during the time I have been involved in advocacy for smoke-free public places. Initially, the purpose was to protect nonsmokers from tobacco smoke. Now, the purpose is apparently to protect people from having to see smokers.

Monday, July 28, 2008

IN MY VIEW: The Increasingly Aggressive War on Smokers -- Why We are Headed in the Wrong Direction

The proclamation by the New York State chapter of the American Cancer Society that smokers are poor role models for their children and its seeming acceptance by anti-smoking groups got me thinking about the drawbacks of what I see as an increasing war on smokers, rather than a battle against smoking, cigarettes, or the tobacco industry.

First, it strikes me as odd that we would be declaring war against smokers, since I am in this business in the first place specifically because I saw the suffering of my smoking patients. My inclination was not to attack them, but to try to help them. The goal, I thought, was to try to reduce future suffering due to tobacco-related diseases, not to try to make the lives of smokers miserable and to marginalize them out into the periphery of society.

But there is no question in my mind that the tobacco control movement has now crossed the line from being anti-smoking to being anti-smoker. In the past months on this blog, I have brought forth numerous stories about tobacco control actions that I believe have no health justification, but which do make the lives of smokers more difficult, make it harder for them to obtain jobs and support their families, or which strip them of their rights. All of these lead to the marginalization of smokers, which unfortunately has adverse health consequences in its own right.

The anti-smoking group's comments about the lack of value of smokers as role models for their children demonstrates the important, although perhaps subtle to anti-smoking advocates, distinction between a perspective that is appropriate and one that is not. The American Cancer Society's comment demonstrates the line that separates public health from bigotry.

Smoking, like eating Vienna Fingers, drinking alcohol, watching violent movies, and eating lots of fatty foods, is certainly not setting a good example for children. That is - the behavior does not set a good example. But this is different from saying that the person - the smoker - is a poor role model. Just like the father who eats Vienna Fingers and lots of other fatty foods may very well be an excellent role model for his kids, so may be the smoker. The point is, it is not health-related behaviors that determine whether one is a good role model for children. We do not ascribe moral value or attribute character or integrity to most health behaviors.

Would the American Cancer Society also say that a fat person is a poor role model for children? Suppose that fat person doesn't get enough exercise and consumes too many calories (which, by definition, is almost always the case). Would the Cancer Society also say that this individual is a poor role model for children?

Are fat people poorer parents than normal-weight ones?

For public health practitioners, the answer is clearly no. For physicians, the answer is also no. For bigots, the answer is yes.

The same is true of smoking. While the behavior of smoking does not set a good example, stating that smokers are poor role models for their children is an example of bigotry.

If the American Diabetes Association came out and stated in a newspaper article that fat people were poor role models for children, I would bet that there would be widespread condemnations of the statement for its bigotry, intolerance, and insensitivity. The same should be the case for the American Cancer Society's statement that people who smoke are poor role models for children.

In addition to the kinds of comments offered by the American Cancer Society, there are numerous aspects of the modern-day anti-smoking agenda which are intended to marginalize smokers:

1. The promotion of policies that restrict employment to nonsmokers -- As I have documented on this blog, a number of tobacco control groups are supporting policies that restrict employment to nonsmokers. The World Health Organization, Cleveland Clinic, Weyco, Scotts Miracle-Gro, and Truman Medical Centers are just a few examples of companies that refuse to hire smokers.

2. The advocacy for policies that treat smokers as child abusers -- A number of anti-smoking advocates have called for smokers who expose their children to secondhand smoke to be treated as child abusers.

3. Support for the refusal of physicians to treat or operate on patients who smoke -- This trend continues to grow. Just this past Thursday, the BBC reported that experts are considering denying IVF treatment to smokers.

4. Support for the refusal to allow smokers to adopt children or serve as foster parents -- Some anti-smoking groups are pushing for smokers to be ineligible to adopt children or to serve as foster parents.

5. Support for, and promotion of efforts to ban all smoking on college campuses -- This is a growing trend, and has no relevance to protecting nonsmokers from secondhand smoke. The aim is to prevent anyone from merely seeing anyone smoking on campus.

6. Support for policies that ban smoking entirely outdoors, including parking lots, streets, and sidewalks -- An example of this trend is the recently enacted policy in Hayward, California which bans smoking on streets and sidewalks. These policies are not necessary to protect people from secondhand smoke, but do give police a legal mechanism to get rid of "undesirable" smokers.

All of these policies are intended to, and have the effect of, marginalizing smokers. What public health advocates need to realize is that the marginalization of a group of people has its own set of adverse effects on health. Not the least important of these is that it makes it much less likely that these people are going to want to quit smoking. When people feel that their lives are being controlled, they are less likely to feel a sense that they can control those aspects of their lives and less likely to have such a desire. Marginalization creates a self-fulfilling prophecy, if you will, that supports the maintenance of the behavior in question.

In addition, marginalization of a group of people has been well-documented to have adverse health consequences. People who are stigmatized may internalize society's hateful feelings, resulting in emotional stress and turmoil and a number of adverse health consequences.

I think that it is time to return the tobacco control movement to being an anti-smoking movement, rather than an anti-smoker movement. We need to abandon workplace smoker policies in a return to workplace smoking policies. We need to ensure that in all of our interventions, we are respecting the autonomy, freedoms, and rights of smokers and not casting moral judgment upon them.

In closing, one of the most important tenets of medicine and public health is that we do not cast moral judgment about our patients (in the case of physicians) or the public (in the case of public health practitioners). We view smoking as an unhealthy behavior, but we do not cast moral judgment on the smoker. We do not refuse to treat smokers or to allow smokers to enjoy privileges and advantages that other members of society enjoy simply on the basis of their having chosen to smoke, unless there are direct medical contraindications.

The tobacco control movement is increasingly violating this tenet of public health practice, and in my opinion, crossing the line from public health to bigotry.

Wednesday, July 23, 2008

Anti-Smoking Advocate Says Smokers are a Bad Role Model for their Children

Russell Sciandra, a leading lobbyist with the New York State chapter of the American Cancer Society, is quoted in the Boston Herald Wednesday as calling smokers poor role models for their children.

According to the article, Sciandra stated: "Parents who smoke are a poor role model for their children."

The quote was apparently in response to a media inquiry related to the all-important story of Britney Spears and her parenting skills. The latest in the saga: Britney was apparently caught on camera smoking in the presence of young Sean Preston. Spears has lost primary custody of her 2 1/2 year-old son and has been criticized in the media for a number of poor parenting episodes, including driving with her son on her lap without a seatbelt, and for his fall from a high chair requiring an emergency room visit.

The Rest of the Story

This was an unnecessary cheap shot. Well ... that's how I see it.

You see ... I actually thought about what I might say to the reporter if she had called me instead. The reason? I got a call from the Boston University media office during the day yesterday. The reporter had wanted to speak to me to get a quote for this story. Unfortunately (or perhaps fortunately for me), I was busy and unable to provide a quote so instead she relied on this quote from Russ Sciandra.

Had the reporter talked to me, I would have stated that what Britney Spears, or any other parent, does in terms of raising their children is their own business (as long as it does not involve abuse or neglect) and that there are probably more serious threats to Sean Preston's well-being than his being exposed to tobacco smoke.

It appears that Russ used the opportunity, instead, to take a pot shot at all smokers.

Now I take issue with his statement, because while I think that smoking (the behavior) certainly does not set a great example, smokers (the parents themselves) are by no means poor role models for their children simply because they smoke. There are a heck of a lot of more important factors in whether parents are good role models for their children than whether or not they smoke.

To name just a few, I would say that how much the parents love their kids and show them love, the values they teach their kids, and the example they set for them in terms of morals such as compassion, kindness, honesty, respect, and tolerance are perhaps some of the most important factors in terms of whether I would consider a parent to be a good role model for their children.

To look only at smoking and state that if someone smokes, they are a poor role model for their child, regardless of all these other factors, seems to me to be narrow-minded and self-righteous.

And once again, it is making a moral issue out of what is merely a health issue.

Are parents who eat hamburgers bad role models for their children? What about parents who are fat? Those who often forget to take their medication? Those who aren't screened regularly for cancer? How about those who do not get enough physical activity? Those who watch movies that have violence in them?

If parents who smoke are categorically poor role models for their kids, then so are parents who engage in all these other unhealthy activities.

But to call a parent a poor role model because of these other activities seems absurd. That's because we don't ascribe moral value to most health behaviors. But for some reason, anti-smoking advocates are now trying to ascribe moral value to the decision whether or not to smoke.

How can we possibly do that? The decision is usually made not in adulthood, but in childhood. As anti-smoking advocates, we ourselves emphasize that these decisions are usually not based on informed, adult, rational decision-making processes, but instead occur during childhood - at least the decision to initiate smoking. Then we argue that the decision to continue smoking is largely influenced by nicotine and addiction. So how can we then turn around and say that smoking is a moral issue and the decision to smoke is an immoral one?

I reject this anti-smoking advocate's view of the smoker because I reject the notion that someone who smokes is automatically a poor role model for children. Some of the best role models for children happen to be smokers. I don't think the smoking or not smoking has anything to do with it. It's a health issue, not one of character or integrity.

I don't understand why this anti-smoking advocate, and many others like him, insist upon portraying smoking as an issue of integrity and character, rather than as simply a health-related behavior.

Now I regret that I wasn't available to speak to the reporter. Because I would have preferred that a message of tolerance and respect be delivered rather than one of moral condemnation. Plus, it would have been awesome to tell my friends that when the media need an expert to comment about the Britney Spears saga, they turn to me for answers.

Tuesday, July 22, 2008

Mike Running Half Marathon to Raise Money for the Leukemia & Lymphoma Society

On August 17, I will be running (attempting to run) 13.1 miles in the San Diego Half Marathon to benefit the Leukemia & Lymphoma Society.

I am running in memory of my mom, who was killed in a tragic car accident when I was 17 years old.

I am also running in memory of my friend Alex Ortiz, who died two weeks ago from lymphoma. Alex was a medical school friend of mine. In addition to being a fine physician, he was one of the most tolerant, respectful, and compassionate people whom I have met. Alex and I spent many difficult times together during our very first medical school rotation, which ironically was in the oncology wards at Yale-New Haven Hospital. Alex and I spent hours of time after work talking to patients, getting to know them and their families, watching television and just hanging out with them. Much of what I learned from Alex I carried with me during my later medical training in terms of my caring for patients.

Anyone who wishes to sponsor me in my run - your donations, no matter how small, would be appreciated.

If you are interested in sponsoring me, pleases make a check directly to The Leukemia & Lymphoma Society and mail it to me at the address below:

Dr. Michael Siegel
Social and Behavioral Sciences Department
Boston University School of Public Health
801 Massachusetts Avenue, 3rd Floor
Boston, MA 02118

Action on Smoking and Health (UK) Claims Secondhand Smoke Immediately Reduces Coronary Blood Flow

According to Action on Smoking and Health - UK, one of the immediate effects of secondhand smoke exposure is to reduce coronary blood blow.

ASH UK's main web page about secondhand smoke states: "Exposure to SHS has immediate health effects. It can reduce lung function; exacerbate respiratory problems; trigger asthma attacks; reduce coronary blood flow; irritate eyes; and cause headaches, coughs, sore throats, dizziness and nausea."

ASH UK back up its contention that brief exposure to secondhand smoke reduces coronary blood flow by referring to the 2001 article by Otsuka et al.

The Rest of the Story

The problem is that the 2001 article by Otsuka et al. found the exact opposite of what ASH UK is claiming. That article found that 30 minutes of secondhand smoke exposure had no effect on coronary blood flow in exposed nonsmokers.

All you have to do is read the abstract of the study to find out that: "Passive smoking exposure had no effect on basal coronary flow velocity in either group."

If you look at Table 1, you'll see that the baseline coronary flow velocity in nonsmokers was 20.2, and that after 30 minutes of exposure to secondhand smoke, the coronary flow velocity was 20.7. Thus, there was no difference in baseline coronary blood flow in nonsmokers exposed briefly to secondhand smoke.

The study did find a reduction in coronary flow velocity reserve. This means that after the intravenous infusion of ATP, the coronary flow velocity in nonsmokers was reduced (just as it would be if the subject ate a hamburger, breathed in car fumes, or experienced a stressful task).

By conflating coronary flow velocity reserve with coronary blood flow, ASH UK is able to create the impression that brief exposure to secondhand smoke can reduce the flow of blood through the coronary arteries and thus put a person at risk of a heart attack. This is certainly a lot scarier than telling people that brief tobacco smoke exposure reduces your coronary flow velocity reserve, similar to what would occur if you ate a hamburger or tater tots.

Would anyone credibly argue that eating tots reduces coronary blood flow? Other than the Anti-Tater Tot Coalition, I'm not aware that anyone would make such a claim. But the research supporting such a claim is the same as that being used to support the statement that 30 minutes of tobacco smoke exposure reduces coronary blood flow in nonsmokers.

For more on the issue of conflating coronary flow velocity reserve with coronary blood flow, see my previous post.

Monday, July 21, 2008

News Article Invokes Smoking Ban as Major Cause of 49% Decline in Heart Attack Admissions in North Cumbria; Junk Science on this Issue Running Rampant

Junk science on the issue of smoking bans and dramatic, immediate reductions in heart attacks continues to run rampant. The latest example is an article in the News & Star (Cumbria, England) which reports that the national smoking ban in England is a major cause of an observed 49% reduction in heart attacks in north Cumbria during a three-month period from October through December, 2007, compared to the same three-month period one year earlier (prior to the smoking ban).

According to the article: "The number of patients suffering heart attacks in north Cumbria has almost halved since the introduction of the smoking ban a year ago. ... According to the Department of Health, there was a 49 per cent reduction in admissions across north Cumbria over a three-month period. This compares to a national drop of two per cent, with the total admissions falling from 4,979 to 4,889. Experts claim that one of the reasons for this drop has been the ban on smoking in public places, which has encouraged more people to give up. The latest figures look at the three-month period from October to December 2006, compared to the same period a year later – after the ban. When broken down they show that, in 2006, 33 people were admitted to the Cumberland Infirmary in Carlisle with heart attacks. This compares with 21 in the same period of 2007. Meanwhile 26 patients were admitted to Whitehaven’s West Cumberland Hospital in 2006, compared with ten over same period last year."

The Rest of the Story

There's just one problem with this "research." The smoking ban is being invoked to explain the 49% decline in heart attack admissions in North Cumbria compared to just a 2% decline in England as a whole. The problem? The control group in this case - England - is not a control group but is, in fact, the intervention group. In other words, the smoking ban was implemented in all of England, so a 49% decline in heart attacks in North Cumbria in light of a much smaller 2% decline in the rest of the country cannot be attributed to the smoking ban.

If anything, these data suggest that the conclusions from Helena, Pueblo, and Bowling Green are wrong and that smoking bans do not produce the kind of dramatic declines in heart attacks that anti-smoking researchers have claimed. After all, a 2% decline in heart attacks is small enough that one cannot be sure any substantial reduction in heart attacks occurred as a result of the smoking ban. But certainly, there was no 40% decline, as claimed in Helena, or a 27% decline, as claimed in Pueblo, or anything close to the 19% decline claimed in a meta-analysis of all the published studies.

Perhaps more alarming than the fact that the conclusions from these data are completely unsupported is the apparent bias in the way these data are being analyzed. One cannot simply compare the number of heart attacks during a chosen period before and after the smoking ban and attribute any change to the smoking ban. Using that same reasoning, one would be forced to conclude that the smoking ban in England had no effect on heart attacks, because in 42% of England's hospital trusts, there was no change (or an increase in heart attacks) during the first year after implementation of the smoking ban.

In fact, the finding that heart attacks declined in 58% of the hospital trusts is not significantly different from the expectation that heart attacks would decline in 50% of the trusts under the assumption that the smoking ban had no effect on heart attacks. If one is really going to employ the reasoning being used in the above analysis, then one would have to conclude that there is no evidence to support the conclusion that the smoking ban had any effect on heart attack admissions.

What I don't really understand are two things:

1. Who is it who is putting out all of this junk science, and why are they doing it? It seems hard to believe that newspaper reporters themselves have some sort of agenda to show that the smoking ban is causing massive declines in heart attacks. It seems more likely that the health department or some other entity is publicizing these data and misleading reporters into believing that the data support such a conclusion.

2. Why is it that these data are not being reported as refuting the conclusions from Helena et al. that there is a dramatic reduction in heart attacks caused immediately by implementation of smoking bans? Whether the decline in heart attacks was only 3% as previously reported or 2% as reported here, these data do not support the conclusion that smoking bans lead to substantial, immediate declines in heart attacks.

What does seem clear is that the studies of the Helena ilk have somehow opened the door for junk science as an acceptable tactic in tobacco control research.

And here is the most amazing thing: very few people or organizations within tobacco control are speaking out against the deterioration of the science.

I think these data from England actually explain why the Helena et al. studies are so flawed. If you just pick several specific locations to study, you are bound to find some locations that experience major declines in heart attacks. Within England, sure enough - Cumbria experienced dramatic reductions in heart attacks. Most of the 49% decline was probably just due to random variation given the low numbers involved.

What you need to do is a systematic study where you look at many locations affected by a smoking ban - preferably examining many countries or many states with such bans and comparable control locations without such bans. When one does this in England, it becomes immediately apparent that the finding in Cumbria was just a fluke. There is no consistent finding of a 49% decline in heart attacks across England. This is called random variation or chance.

Most likely, locations chosen for study are those in which investigators notice that there seems to be a decline in heart attacks. If heart attacks went up after a smoking ban, most likely investigators in those locations would not opt to conduct and publish such a study.

Interestingly, this serious problem of publication bias is not even mentioned in the meta-analysis of these studies which was recently published online in Preventive Medicine.

To really answer this research question, what is needed is a systematic study of multiple locations with smoking bans. I believe that McFadden and Kuneman have conducted such a study, in which they examined heart attack trends in a number of U.S. states with and without smoking bans for which data were available. This study has not yet been published, as not surprisingly, it is probably getting unfair reviews from anti-smoking researchers.

I conducted my own analysis of the data, using McFadden and Kuneman's methods, for all U.S. states with and without smoking bans for which data were available. I found no evidence that there is any substantial, immediate decline in heart attack admissions in states with smoking bans.

It doesn't make sense to me that anti-smoking researchers and groups aren't willing to criticize the conclusions of these studies and to decry the junk science that is being used. After all, deterioration of the science being used in tobacco control is not an asset; it is a severe liability.

However, as I am learning, science in tobacco control is judged not by its quality, but by the direction of the results.


(Thanks to Michael J. McFadden for the tip).

Wednesday, July 16, 2008

New Research Confirms that Tobacco Companies Use Menthol to Support Addiction, Especially Among Adolescents; Results Reveal Hypocrisy of TFK Actions

An article released today by the American Journal of Public Health concludes that tobacco companies use menthol to enhance addiction of smokers, especially adolescents and young adults. The study, which reviewed tobacco industry documents, examined data on menthol cigarette advertising and use, and tested cigarettes directly, was conducted by researchers at the Harvard School of Public Health (see: Kreslake JM, Wayne GF, Alpert HR, Koh HK, Connolly GN. Tobacco industry control of menthol in cigarettes and targeting of adolescents and young adults. American Journal of Public Health 2008).

The researchers found that tobacco companies use menthol to aid the addiction process of new, adolescent smokers. The menthol works through its anesthetic effects on the respiratory tract, which reduce the harshness of the initial smoking experience. Cigarette company research revealed that a low level of menthol can reduce the initial negative reaction to cigarette smoking. Since the initial negative reaction turns many adolescents off of cigarettes permanently, reducing this reaction can be the key to successfully addicting a youth.

For example, an R.J. Reynolds document notes that: "First-time smoker reaction is generally negative. . . . Initial negatives can be alleviated with a low level of menthol."

The memo also notes that: "Once a smoker adapts to smoking a menthol product, the desire for menthol increases over time. A brand which has a strategy of maximizing franchise acceptance will invariably increase its menthol level."

Thus, manipulation of menthol levels in cigarettes plays a substantial role in sustaining addiction to cigarettes as smokers become older and more experienced.

The article concludes: "Cigarettes are nicotine delivery devices. They are engineered to promote initiation and transition to addiction through design features that make the products more attractive and palatable. Although menthol is not addictive, it may contribute to tobacco addiction by promoting initiation and facilitating inhalation of smoke."

The Rest of the Story

First and foremost, this research exposes the hypocrisy of the Campaign for Tobacco-Free Kids, the American Medical Association, and other groups which are supporting the FDA tobacco legislation and actively opposing the Congressional effort to remove the menthol exemption.

These groups are arguing that we need to ban cigarette flavorings because these flavorings help induce young people to start smoking. They are supporting a ban on a wide range of flavors, including cherry, chocolate, strawberry, banana, mint, clove, raspberry, and even snozberry. Yet there is no scientific evidence that any of these flavorings are actually used to recruit and addict young smokers.

On the other hand, we now have solid evidence that menthol is actually being used by cigarette companies to recruit and support addiction among literally millions of young smokers. So what does the Campaign for Tobacco-Free Kids want to do with this flavoring? Ensure that it can remain in cigarettes, because smokers are actually using it!

This hypocrisy is just too absurd to be true. How can a public health group argue, on the one hand, that tons of flavorings that are not being used to any substantial extent to recruit young smokers need to be banned, but that the one flavoring that has now been conclusively shown to be contributing toward the addiction of millions of smokers needs to remain on the market?

I'm not arguing here that menthol products need to be removed from the market. I'm arguing that it is complete and utter hypocrisy to argue that chocolate needs to be banned from cigarettes, but that menthol needs to remain.

Second, I find it ironic that here we now have evidence of the one thing that the FDA legislation could potentially do that would actually make a dent in youth smoking, but the Campaign for Tobacco-Free Kids opposes it. All of the other measures in the legislation are not going to do a thing to prevent youth smoking. Now we have an evidence-base to support an action that we know will make a substantial difference, and the Campaign for Tobacco-Free Kids and its partners are opposing it!

Third, this story reveals just how apparent the lack of an evidence-base is in the national tobacco control movement. Where there is no evidence to support action, the health groups are demanding regulation. Where there is solid evidence to support action, the health groups are demanding that Congress not intervene. This is insanity!

Once again, I'm not calling on the regulation of the constituents of tobacco products. It should be well known to my readers that I am opposed to that concept and I don't think it is appropriate for the FDA to be entrusted with such a mission. However, it is ludicrous for those who are calling on the FDA to regulate cigarettes to give the Agency numerous tasks for which there is no evidence to suggest there will be any positive effect on the public's health, but to ban the Agency from taking the few actions for which there is evidence that there would be a positive effect on the public's health.

The loopholes in the bill, which preclude it from taking exactly those actions for which there is evidence that a dent in cigarette use would occur -- including the menthol exemption -- represent sellouts that occurred at the negotiating table with Philip Morris. To be holding on to these sellouts even after Congressional leaders themselves have demanded that the loopholes be removed and after research has been presented demonstrating why the loopholes are critical to the protection of cigarette sales is unconscionable.

American Medical Association Leadership Ignores Overwhelming Sentiment of Members; Refuses to Listen to Membership and Supports Current FDA Bill

Despite a vote by its members indicating support for the removal of all cigarette flavorings, the American Medical Association (AMA) leadership has refused to accept the opinions of its members and has instead opposed the removal of the menthol exemption from the FDA tobacco legislation.

On June 17, the American Medical Association voted to adopt the following policy regarding the removal of cigarette flavorings:

"In recent years tobacco products have been developed in a variety of flavors including chocolate, vanilla, mint and fruit. Surveys have shown that children are more likely to choose flavored tobacco products. Because these products appear to be specifically marketed toward children, today the AMA spoke out in support of state legislation that would prohibit the sale or distribution of flavored tobacco products."

According to an AMA press release supporting the removal of all cigarette flavorings: "Research shows that the earlier a person begins smoking the more likely he or she will become addicted to tobacco products and will continue to smoke throughout his or her lifetime," said AMA Board Member William Dolan, M.D. "We all know the dangers of smoking and by prohibiting the sale of flavored tobacco products targeted toward children, we may be able to keep the younger generation tobacco free."

Despite passage of this resolution, the AMA leadership continues to oppose the removal of the menthol exemption, and is thus supporting the continued use of menthol flavorings in cigarettes, which is at odds with the policy vote of the AMA members. According to an Associated Press article, AMA president Dr. Ron Davis said he was continuing to support the menthol exemption despite the sentiment and vote of AMA members because removing the exemption "might derail the legislation."

The Rest of the Story

So you mean to tell me that despite the vote of the AMA members, the AMA leadership is supporting the continued sale of menthol cigarettes and the continuing addiction of our nation's youth because it admits that it wants to protect Philip Morris profits from menthol sales and thus retain its political alliance with Philip Morris in support of the FDA legislation?

The rest of the story is that this may be one of the saddest chapters in the history of the AMA's support of the tobacco industry.

What surprises me, however, is that I thought this history had come to an end. Sure, the AMA has a long relationship with the tobacco industry and has been one of the strongest financial supporters of pro-tobacco legislators. But I thought that times had changed and that the chief organization representing America's physicians would relinquish its long-time role in protecting tobacco industry interests.

Well, I guess times haven't really changed after all. The AMA continues to ally itself with the tobacco industry, and in this case, to actively try to block efforts to protect the public's health by improving the FDA legislation in order to protect the financial interests of the leading cigarette company, whose Marlboro Menthol product is the 2nd leading menthol brand on the market.

My only regret is that I quit the AMA years ago. I would have loved to send in my AMA resignation in response to this gaffe.

Tuesday, July 15, 2008

Support for FDA Tobacco Legislation Continues to Crumble; Truth May Win Out in the End

Support for the proposed FDA tobacco legislation continues to crumble, as several more anti-smoking groups have announced their public opposition to the legislation.

Action on Smoking and Health (ASH) issued a statement in which it opposed the legislation unless it is amended to remove the menthol exemption. This is a provision in the legislation, included as a compromise to Philip Morris (whose Marlboro Menthol brand is the 2nd leading menthol brand in the country), exempts menthol from the list of cigarette flavorings that are banned by the legislation.

ASH wrote: "While the bill would ban the use of virtually all substances (e.g., clove, peppermint) used to flavor cigarettes, and to mask the harsh taste most young children experience when they first try smoking, the bill exempts menthol. But menthol is used overwhelmingly be African Americans, and makes it much harder for users to quit smoking once they get hooked. That's why this lethal "racist" loophole is being condemned by the Congressional Black Caucus, the National African American Tobacco Prevention Network, many former HHS Secretaries, and now by ASH."

ASH argues that the menthol exemption is racist, or at least racially insensitive, because it creates a systematic discrepancy in health protection that disproportionately affects African Americans: "the argument that the exception of menthol from the bill does not discriminate against African Americans seems inconsistent with clearly established American law which recognizes that actions or laws which have the “effect or consequence” of having a discriminatory impact on Blacks may violate civil rights laws prohibiting such discrimination." ...

"Thus the inescapable conclusion is that, at the very least, the menthol loophole would have a racially discriminatory impact, and debating the bill in its current form could well raise serious racial issue just prior to critical elections in which race is already playing a major factor. The fact that this lethal menthol loophole was apparently negotiated without a single representative from an African American organization [like the National African American Tobacco Prevention Network, which said 'our constituents across the country are just livid' at being excluded from any representation in negotiations on the menthol loophole”], or even of African Americans prominent in the antismoking and public health movements, only adds to that impression."

In a press release, ASH argued that by agreeing to this compromise, the Campaign for Tobacco-Free Kids has sold out the health of African Americans in order to appease the financial concerns of Philip Morris: "sacrificing African American children to mollify the largest killer of Blacks in the U.S. is nothing short of grotesque and obscene, and may well be counterproductive and totally unnecessary. . . . passing the bill with the menthol loophole is racist (or at least racially insensitive)."

ASH also condemned the Campaign for Tobacco-Free Kids for negotiating this bill with Philip Morris, for doing so in secret, and for failing to open the process up to any other tobacco control groups, especially those representing communities of color: "ASH also objected that such an exemption was apparently negotiated in secret with a tobacco company to gain its support, and with virtually no input from individuals and organizations with both a special interest and a unique perspective on African Americans, public health, and cigarettes."

Maryland GASP has also come out against the legislation. A column in the Maryland Gazette by its president - John O'Hara - condemns the legislation for its numerous loopholes which O'Hara says give the tobacco industry virtual control over the FDA. He also points out that the legislation sells out the health of African Americans to protect tobacco industry profits. The column argues that this legislation should be abandoned and that groups need to go back to the drawing board and develop a true piece of tobacco control legislation for the next Congressional session.

The Daily Voice, described as "Black America's Daily News Source," featured an article about the menthol exemption in the legislation. The piece argues that: "It is believed that Philip Morris actively lobbied Congress to include the menthol exemption, which is financially critical to the American tobacco industry's profit margin." The article goes on to assert that this compromise in the legislation is inappropriate because it an institutional example of how the "tobacco industry continues, after nearly a century, to enslave our community in many creative ways."

The Rest of the Story

There are two important implications of this story.

First, from a practical perspective, I believe that the FDA tobacco legislation is dead for this legislative session. I don't see any way that the bill can overcome the dual devastating blows of the widespread media coverage of the menthol exemption and its being framed as a sell-out to Philip Morris, as well as the crumbling of the coalition of support and internal misgivings of groups about being on board with the tainted process that led to the legislation in the first place.

If nothing else, the menthol guffaw gives bill opponents a perfect way to defeat the bill on the Senate floor: simply introduce an amendment to remove the menthol exemption. Doing so will tie the hands of bill supporters. If they vote against the amendment, they are exposing themselves as tobacco industry protectionists who are willing to sell out the health of African Americans to protect cigarette company sales. If they vote for the amendment, they are unlikely to be able to garner enough votes to break any filibuster and move the legislation forward.

Most likely, the effect of the menthol guffaw will be to convince Senate leaders not to bring the bill to the floor in the first place. They will probably want to avoid the embarrassment of a showdown over the menthol issue.

From a political standpoint, bringing the bill to the floor under these conditions will take the focus off the public health aspects of the bill and displace it over to the menthol exemption and to the appeasement of tobacco industry interests. The potential political gains to be garnered from support for the legislation have been greatly obscured.

The second important aspect of this story is that it shows the power of the truth. As the truth is gradually (albeit slowly) revealed and digested by the tobacco control community, groups are beginning to line up in droves against the legislation. The coalition of support is crumbling because no one wants to be seen as standing up for the financial profits of Big Tobacco, which is what the Campaign for Tobacco-Free Kids is doing by negotiating this deal with Philip Morris, supporting it in Congress, and opposing any amendments to strengthen the bill.

People are willing to stay on a sinking ship only so long. Once they can actually see the water pouring into the ship, they head for the lifeboats.

It's time for the tobacco control movement to abandon this sinking FDA legislation ship before it capsizes. We need to regroup on shore and build, together, in an open and inclusive process, a new ship. Hopefully, the ship we build in the next legislative session won't be called - like its predecessor - the S.S. Philip Morris.

Monday, July 14, 2008

New York County Legislator Seeking to Ban Smoking Outdoors Because It Sets a Bad Example

According to an article in the Daily Freeman (Kingston, NY), a Dutchess County legislative leader is promoting a smoking ban for all county parks and their parking lots because smoking sets a bad example for children. A similar law being considered in neighboring Ulster County would ban smoking on all county-owned property.

According to the article: "With smoking now banned in all indoor public spaces in New York state, some county officials in Ulster and Dutchess hope to join a growing number of municipalities to snuff out smoking in outdoor areas as well. The Ulster County Legislature last week set a public hearing for 6 p.m. Aug. 6 on a proposed local law that would ban smoking on all county-owned or county-controlled property. Members of the Dutchess County Legislature's Public Works Committee, meanwhile, are expected on Monday to discuss a proposal to ban the use of tobacco in county parks. ..."

"'I just feel there shouldn't be tobacco use in county parks,' said Dutchess County Legislature Majority Leader Sandra Goldberg, who led the Dutchess initiative. Goldberg, D-Wappinger, said the county's parks are intended to be a "family place" and the presence of smokers is not only harmful to those forced to breathe second-hand smoke, but it sets a bad example for children. Nearly the entire Democratic caucus in the county Legislature supports the Dutchess measure, Goldberg said."

The Rest of the Story

We will be in serious trouble when we start outlawing health behaviors in public merely because they set a bad example. Are we going to outlaw eating french fries in public because it sets a bad example to children regarding a healthy diet? Are we going to outlaw severely overweight people from public parks because they set a bad example for children? What about teenagers who have babies? Should they be banned from public parks because it sets a bad example for children?

The same reasoning that Majority Leader Goldberg is using to support banning smoking in county parks would also support each of these other measures.

The danger here is that Goldberg is turning smoking into a moral, rather than strictly a health issue. It is crossing that line from health into morals, with regards to smoking or any other health behavior, that I find unacceptable, inappropriate, and frankly - dangerous.

As I see it, smoking is not a moral issue. It is a health issue. And that's all.

Prohibiting certain behaviors in public places - such as drinking alcohol, public nudity, public sex, etc. - is justified on the grounds of public morals. There are certain behaviors which in the collective wisdom of society are viewed to violate public morality, particularly as they relate to being viewed by children.

What Goldberg is essentially doing is equating smoking with these other behaviors. She is, in fact, making a moral argument about smoking. This does cross the line from treating smoking as a public health issue to treating it as an issue of public morals.

If Goldberg and other legislators want to argue that smoking needs to be banned on all county property because it represents a substantial threat to the public's health, then they are free to make that argument and I have no problem with it. Good luck to them in trying to garner evidence to support the contention that smoking in parking lots at county parks or county buildings is a serious public health problem, but they are free to attempt to do so.

However, to argue that smoking needs to be banned on all county property because we need to protect kids from seeing this morally inappropriate behavior is no longer a public health argument. It is a public morality argument and it has no place in this debate.

Thursday, July 10, 2008

Scene Smoking Still Claims that Tobacco Kills 124,000 Young People A Year; We Can Safely Conclude that They Do Not Care About the Facts

Eight and a half months after pointing out directly to Breathe California of Sacramento-Emigrant Trails that a central "fact" on its Scene Smoking web site was incorrect, the "fact" remains unchanged. The Scene Smoking web site of Breathe California of Sacramento-Emigrant Trails still claims that: "Smoking Kills About 340 Young People A Day."

This claim, which is equivalent to stating that smoking kills 124,000 young people each year, is blatantly absurd, and false on its face. Obviously, smoking doesn't kill 124,000 young people each year.

In its communications with me, Breathe California of Sacramento-Emigrant Trails has never argued the point. They have not defended the claim. Instead, they have maintained that they intend to change it but that the web master is away and unavailable, and that the claim cannot be changed without the web master.

The Rest of the Story

At this point, almost nine months after first reporting this "mistake" to the organization, it is becoming apparent to me that Breathe California of Sacramento-Emigrant Trails just doesn't care about whether the information on its web site is accurate or not. What else can I possibly conclude, given that they have known about this blatant factual error for more than eight months and have still failed to correct it?

It appears that this anti-smoking group, like an increasing number of such groups in my experience, believes that the cause is so important that the facts really don't matter. It doesn't matter whether you are telling the public the truth, because the cause is so important and valuable. The ends justifies the means. It is acceptable to communicate false information to the public because the ultimate cause is a good one. When you are made aware that information you are communicating is false, it is not important to correct it. You can get to it whenever you get around to it. Let people continue to be misled and deceived. It's OK, because this is all for a good cause.

I'm sorry, but I just don't accept this attitude. I don't know what is more important to the tobacco control movement than its scientific integrity. Moreover, I believe we have an ethical obligation to communicate accurate information to the public. Certainly, we make mistakes, but when that occurs, you correct them as soon as possible. Eight and a half months and counting is not "as soon as possible."

This also leads me to question whether the original claim is actually a mistake. It seems difficult to believe that the organization could have made a simple careless error and ended up with the claim that smoking kills about 340 young people a day. It's not like a simple typographical error or careless construction of the statement could have resulted in the erroneous nature of the claim. It's a pretty simple and straightforward assertion, and it's hard to believe that one could make such a claim without really meaning it, or that one could fail to be aware of what one is actually asserting by such a statement.

Add to this the organization's failure to correct the statement and one is left with the impression that this may not be a mistake, but that it may be an intentional effort to deceive. In fact, one could argue that since the organization was aware of the inaccuracy of the claim eight and a half months ago, its continuing dissemination of the claim to the public represents intentional deception.

For the past eight and a half months, this certainly cannot be an example of an unknowing deception of the public. It is now being done in a deliberate way. The organization has apparently made a choice to leave the claim on the web site for the past eight and a half months.

I don't mean to pick on this one organization, but I think this is an important story because it demonstrates why I have come to believe that the tobacco control movement largely doesn't care any more about its scientific accuracy. It is truly becoming clear to me that the cause is more important than anything, even the truth. If we need to tell lies to accomplish our goals, so be it, because the cause is just so important.

I find it ironic that much of the basis for tobacco control is the premise that the tobacco companies have been communicating misleading and inaccurate information to the public for many years. Interestingly, there are few examples of outright material misrepresentations of facts by the tobacco industry. Mostly, the examples are those of misleading portrayal of information. But here, we have an example of outright dishonesty. I would argue that the statement in question is not merely misleading; it is demonstrably false.

Do we really need to stoop down so low, below the level of even the tobacco industry, to make our points to the public?

Tuesday, July 08, 2008

ASH Reiterates its Claim that 30 Minutes of Secondhand Smoke Increases a Nonsmokers' Risk of a Heart Attack to that of an Active Smoker

Action on Smoking and Health (ASH) has reiterated its claim that 30 minutes of secondhand smoke increases a nonsmoker's risk of suffering a heart attack to the same level as that of an active smoker.

On its web site, ASH now repeats its claim that "even 30 minutes of exposure to small amounts of drifting secondhand tobacco smoke can increase a nonsmokers' risk of a heart attack to that of a smoker."

ASH states that its claim is based on the following two statements made in the scientific literature:

Statement 1
"the effects of even brief (minutes to hours) passive smoking are often nearly as large (averaging 80% to 90%) as chronic active smoking."

Statement 2
"Even 30 minutes of exposure to a typical dose of secondhand smoke induces changes in arterial endothelial function in exposed non-smokers of a magnitude similar to those measured in active smokers."

The Rest of the Story

This claim by ASH is not only inaccurate, but it is absurd on its face. There is no way that 30 minutes of secondhand smoke can increase the risk of a heart attack to the same level as that observed in a chronic, active smoker. If this were true, then the tobacco industry could legitimately claim that: "active smoking is no worse [in terms of heart attack risk] than being exposed to drifting tobacco smoke for 30 minutes." Obviously, a smoker's risk of a heart attack is far greater than the risk for a nonsmoker exposed to secondhand smoke for a half hour.

So ASH has got it completely wrong here. But how? How could ASH so thoroughly distort the science that it became blatantly false?

The answer is that ASH has conflated endothelial dysfunction with heart attack risk. Both statements #1 and #2 above relate to endothelial dysfunction. What the key study found (there is really only one study here, but the same study is being referred to in both statements) is that 30 minutes of secondhand smoke exposure increased endothelial dysfunction (as measured by coronary flow velocity reserve) to the same extent in nonsmokers as in smokers.

The study did not find that 30 minutes of secondhand smoke increases heart attack risk to the same level as that of smokers.

Had ASH stated: "even 30 minutes of exposure to small amounts of drifting secondhand tobacco smoke can increase a nonsmokers' risk of endothelial dysfunction to that of a smoker," or "even 30 minutes of exposure to small amounts of drifting secondhand tobacco smoke can decrease nonsmokers' coronary flow velocity reserve to that of a smoker" then the statement would
have been correct.

But by distorting the statement to assert that a nonsmoker's risk of a heart attack is increased to the same level as that of a smoker, ASH has factually misrepresented the truth.

I am not accusing ASH of intentionally lying. Another possibility is that they are lawyers and not physicians, simply do not understand the difference between measuring endothelial dysfunction and measuring heart attack risk, and are simply out of their league in interpreting science like this. However, if this is the explanation for this scientific misrepresentation, then it is still inexcusable. A public health organization that puts itself forward as being a trustworthy source of medical and scientific information to the public has a responsibility, I believe, to be reasonably careful in crafting its public communications. If scientific incompetence is the explanation for ASH's dissemination of false information, then ASH remains guilty of failing to exercise even the most minimal level of care in communication of health information to the public.

There are a number of adverse implications of ASH's actions.

First, by blatantly distorting and misrepresenting the science, ASH has threatened the credibility and reputation of all of us in tobacco control. It is quite obvious, even to much of the lay public, that ASH's claim is absurd. There is no way that 30 minutes of secondhand smoke exposure can put nonsmokers at the same level of heart attack risk as smokers. I am afraid that people are going to realize this and realize that the tobacco control movement is misrepresenting the science. While it is one particular group making this claim, I think people will attribute the behavior more generally to the entire movement.

Second, by being untruthful in its health claims, ASH has threatened the scientific integrity of the tobacco control movement. There is an ethical public health standard of honesty in scientific communication which I believe ASH is violating here (whether intentional or not) and it reflects poorly on the entire movement, even groups which are not making this claim.

Third, by distorting the science so severely, ASH risks undermining the public's appreciation of the hazards of active smoking and undermining years of public health efforts to educate the public about the severe cardiovascular disease harm of cigarettes. If the public truly believes that the heart attack risk associated with active smoking is only as bad as that produced by breathing drifting tobacco smoke for a half hour, then the public's perception of the severity of the heart attack risk of active smoking will certainly decrease. This statement could easily lead smokers to believe that they are not at a particularly high risk of a heart attack. It could easily deter smokers from quitting and undermine efforts to prevent youths from starting to smoke.

Remember that in an equation, it doesn't matter which side you put first. If you state that A = B, then you are also stating that B = A.

Thus, if you state that a nonsmoker's risk of a heart attack after exposure to 30 minutes of tobacco smoke is the same as that of a smoker's, you are also stating that a smoker's risk of a heart attack is merely that of a nonsmoker who breathes in drifting smoke for a half hour.

Had ASH stated the claim that way, I think it would have been immediately obvious to people that they were pulling their legs. In fact, if the tobacco industry put out such a claim (which they could easily do based on ASH's statement), I am sure anti-smoking groups would be attacking the industry for making such an absurd claim.

In fact, I have a brilliant idea for the tobacco industry which I'd like to pass along. They can, without any risk of liability, point out to their smoking consumers that "Even anti-smoking groups agree that your risk of suffering a heart attack is no higher than that of someone who doesn't smoke but merely breathes in tobacco smoke for 30 minutes."

I would make that the basis of an education campaign directed to all smokers, and to the public. I would call the "Understand Your Risk" campaign. In all literature or other communications produced by the campaign, I would clearly cite Action on Smoking and Health for the statement, so that there is no risk of liability for making a false claim. In the statements, I would make sure to specify: "according to an anti-smoking group....".

Since ASH didn't specify a maximum smoking duration in its claim, as a tobacco company, I believe I could safely reassure my long-term customers of 30-40 years not to worry, because their risk of a heart attack is no worse than it would be if they had never smoked, but had simply once walked into a smoky bar for a half hour.

Clearly, ASH's claim also undermines the importance of the dose-response relationship between cigarette smoke exposure and heart attack risk. If it is true that a smoker's risk of a heart attack is no higher than someone who walks into a smoky rib shack for 30 minutes one time, then smoking for 40 years doesn't put you at any increased heart attack risk as smoking for 20 years, or for 1 year for that matter. Smoking 4 packs a day isn't any worse than smoking a few cigarettes a day. And most devastatingly, quitting smoking apparently will not reduce your heart attack risk at all if you still hang out with your smoking friends for a half hour on occasion. So why quit smoking?

Before closing, I think it is important to point out that ASH's original claim, which it maintains to this day on this web page, appears to be false. ASH claims that "the CDC has warned that breathing drifting tobacco smoke for as little as 30 minutes ... can raise a nonsmoker’s risk of suffering a fatal heart attack to that of a smoker."

However, I can find no evidence that the CDC has indeed warned that "breathing drifting tobacco smoke for as little as 30 minutes can raise a nonsmoker's risk of suffering a fatal heart attack to that of a smoker." The CDC did warn that breathing secondhand smoke for as little as 30 minutes can reduce coronary flow velocity reserve to that of a smoker. But nowhere did CDC warn that brief tobacco smoke exposure increases heart attack risk to that of an active smoker.

My argument of course hinges on their being a critical difference between the finding of reduced coronary flow velocity reserve and the finding of an increased heart attack risk. In fact, having reduced coronary flow velocity reserve does not equate to being at an increased risk of a heart attack. In the healthy volunteers who were studied by Otsuka et al., there was no increased heart attack risk faced by these patients. Had there been such a risk, then the study would have been unethical and it never would have been approved by an institutional review board. Certainly, the subjects would have had to be warned that they would face an increased risk of heart attack and possibly death.

Moreover, eating a hamburger reduces coronary flow velocity reserve to roughly the same extent as in an active smoker. Would it therefore be accurate for ASH to claim that "eating a single hamburger can increase a person's risk of a heart attack to that of a smoker?" Of course not. If you walk into McDonald's and order a hamburger, you may be at risk of disease, but not from immediately keeling over from a heart attack.

Luckily, the tobacco companies are a little more honest than ASH is being here, and they have not taken this opportunity to claim publicly that: "Smoking puts you at no more risk of a heart attack than eating a single hamburger." Based on ASH's statement, the tobacco companies could accurately make such a claim. The tobacco companies aren't misrepresenting the science about this. Why is ASH?

Monday, July 07, 2008

IN MY VIEW: Study on Effect of England's Smoking Ban on Quit Rates Not Only Represents Science by Press Release; It Also Appears to Be Shoddy Science

I have already discussed why the study on the effect of England's smoking ban on quit rates is problematic on the grounds of it representing science by press release. Today, I posit, based on the limited information available about the study, that its conclusions are questionable as well. In light of science by press release approach, this is extremely problematic, because the conclusion has already been widely disseminated by the media.

Based on the little information we have available (i.e., the limited information that was provided by Cancer Research UK in its press release and which is publicly available on the internet), it appears that the conclusion of this study - that the smoking ban substantially reduced the quit rate in England - is based on a comparison of two data points: the quit rate during the nine months preceding the smoking ban (which was 1.6%) and the quit rate during the nine months following the smoking ban (which was 5.5%).

While it may appear, on the surface, that the smoking ban had a dramatic effect on the quit rate, increasing it from 1.6% to 5.5%, one cannot conclude that there was a causal effect of the smoking ban on the quit rate unless one can rule out the possibilities that the change in quit rate represents: (1) random variation in the quit rate over time; (2) a secular change in the quit rate that would have occurred in the absence of the smoking ban; and (3) a change that is attributable to some other factor.

In order to accomplish the above, one needs to do three important things:

(1) calculate the quit rate for several years prior to the smoking ban, preferably for about 8 years or so, in order to establish the baseline variability in the quit rate over time;

(2) compare the change in quit rates over time to changes in the quit rate in a comparison location, presumably a nearby country or countries without a smoking ban; and

(3) somehow rule out the possibility that there is another factor which may explain the change in quit rate -- in this case, that includes the implementation of another important policy change in October 2007: an increase in the legal age of purchase of tobacco from 16 to 18.

From what I can tell, the study did none of these three important things.

First, its conclusion appears to be based on a comparison of just two data points: the quit rate in 2006-2007 and 2007-2008. It doesn't even appear that data for the entire year following the smoking ban were used. It doesn't appear that the quit rate was determined for the years prior to the smoking ban. Rather than going back 8 years or so, it doesn't even appear that the study went back for a full year prior to the smoking ban.

While the Smoking Toolkit Study made an attempt to estimate historical quit rates, these rates were not actual rates but were very rough estimates, and they cannot be compared with the quit rate as calculated after the smoking ban. The methods are completely different and cannot be compared directly. The investigators themselves acknowledge that the historical quit rate calculations are very rough and should be taken with a grain of salt: "We do not have the data to be able to calculate background quit rates in the UK population but we can estimate historic rates and rates in the past year indirectly as long as certain assumptions hold true. ... Because of the assumptions involved in the estimates and the sample size used to calculate these figures, these figures must be treated with caution."

Even more troubling is the fact that there has been an impressive trend of declining smoking prevalence in England. In fact, one article pointed out that there was a reduction of 400,000 smokers between 2003 and 2004 -- the same reduction that between 2007 and 2008 is being attributed to the smoking ban. The article reports that there was a decline of 1.2 million smokers in England from 1998 to 2003. It was in 1998 that the Smoking Kills White Paper was released.

Second, it does not appear that any comparison country or location was used. This makes it very difficult, if not impossible, to conclude that any observed changes in quit rate would not have occurred anyway in the absence of the smoking ban.

Third, it does not appear that other potential causes of an increase in quit rate were ruled out, including the potential effects of the increase in the legal age of purchase of cigarettes and all the media attention to tobacco produced by the debate over the proposed smoking ban.

It is unfortunate that the investigators have issued this press release and garnered widespread media coverage of their conclusions without making the study available for review, so that we could ask precisely the above questions and review the methodology to examine how these three important issues were addressed, if at all.

This is now extremely problematic because if I am right and these conclusions are not justified based on the study's major limitations, it is really too late. The conclusions have already been widely disseminated to the public. Are newspapers going to run a special article that says: "Remember that story last year about how the smoking ban dramatically increased quit rates in England? Well, it turns out that the conclusion was invalid because the investigators could not rule out the possibility that the observed increase in the quit rate was due to random variation, rather than to a causal effect of the smoking ban."


(Thanks to GreatScot and Tim Clarke for ideas used in this post).

Thursday, July 03, 2008

Special "Independence" Day Post: Australians May Need a License to Smoke

Adults in Australia who smoke may soon be required to obtain a "license to smoke," according to an article in the Victoria Herald-Sun.

According to the article: "Health Minister Nicola Roxon has warned smokers she is prepared to take radical action to force them to give up. A smoker's permit could be among the "innovative options" employed to get Australians to quit. The permit, which smokers would have to buy annually and display every time they bought cigarettes, has been mooted in Britain. ... Under Britain's permit proposal, smokers would have to renew their permit every year and display it when buying cigarettes."

This proposal has been endorsed by a leading tobacco control researcher and advocate - Dr. Simon Chapman of the University of Sydney School of Public Health - who writes in a July 4 column on an Australian news web site: "Why not license smokers? After all, doctors issue tens of thousands of temporary licences every day in the form of prescriptions to allow us to access drugs that can save lives and improve health. Critics scoff at the idea, arguing that there would be too many difficulties in policing it, or that an underground market for cigarettes would develop. Given that obtaining a licence for other activities is so straightforward, these arguments hold little weight. Introducing a smoker-licensing scheme could be readily managed by allowing all current adult smokers over the age of 18 to acquire a permit. To be eligible, smokers would need to have their doctor affirm that they are smokers and then apply for a photo ID swipecard. Any new smokers wanting a licence after the scheme's starting date would be required to take a test, proving they fully understood the many health risks of smoking. ID cards could be swiped at stores to limit the number of cigarette packs that could be bought at a time. Two packs a day maximum, say. This would help to minimise a blackmarket of cigarettes being sold on to unlicensed or under-age smokers. And, just as for a driving licence, smokers would need to renew their commitment to smoking every five years."

The Rest of the Story

This is a wonderful idea, but why restrict it just to smoking? There are all sorts of health-related behaviors for which people should be required to have a permit.

First of all, people should have to hold a license to drink. I propose a system of licenses by which you are certified at a certain level of drinks allowed per time period. You have to first take a drinking test to see how well you hold your liquor. Based on your test score, your license then indicates how much you can drink without posing a threat to yourself or others. A doctor would have to certify that you indeed do drink alcohol. Upon entering a bar, the bouncer would check your license and then stamp your hand with the appropriate number of allowed drinks. The bartender would check off your stamps as each drink is served.

Second, if you need a license to fish, you definitely should need a license to become a parent (to borrow a motif from the movie "Parenthood"). A quick parenting test could be required. Baby dummies could be used with real sound effects to simulate the conditions you need to be able to recognize. You should be required to demonstrate your ability to change a diaper while talking on a cell phone and with a dummy toddler in a standing position, useful when you are using your drinking license in a bar with bathrooms that are not baby-friendly.

Prior to your child becoming an adolescent, you would need to renew your parenting license. You would be tested in a simulation in which you would try to conduct a conversation with a testing official who refuses to listen to anything you have to say and doesn't want to be seen in your presence or acknowledge that you exist, except to ask for money to take when he goes out with his testing buddies.

Third, you should need a license to buy red meat. With a doctor's certification, you get a permit that allows you to purchase red meat at the grocery store. However, there is a strict limit of two steaks at a time, to prevent a possible black market for rib eye and rump. Before receiving your license, you would of course be required to pass a test demonstrating knowledge of the harmful effects of eating high amounts of fat.

Licenses to purchase tater tots should also be required, but available only through a highly competitive lottery system.

Fourth, a permitting system should be established for sunbathing. Licenses would be granted only after completing an educational program about skin cancer and methods to help prevent sun exposure.

On a similar note, licenses should also be required to go to a tanning salon. A physician's note as well as successful completion of a course in dermatological oncology would be required.

Restaurants which continue to serve trans-fats should require their customers to hold a permit before ordering any food that contains more than 0.5 grams of trans-fat. A swipe card system could be developed which automatically keeps track of your trans-fat intake for the week. Once you reach the weekly maximum, you would be denied any further trans-fat containing menu items.

Unsafe sex would still be permitted under this system, but would require a license, for which one would need a doctor's note and successful completion of an exam on sexually transmitted diseases. There would also be a weekly partner maximum.

Fat people would need a license to eat out in restaurants, and would have to pass an additional certification exam to eat out at fast food restaurants. A special mark on the license, obtainable only with a doctor's permission, would be necessary to supersize it.

A special thrill-seeking license would be required for activities like bungee jumping, skydiving, rock climbing, sky surfing, and freestyle motocross. Skateboarding permits would be on a graded system, with funbox, grind box, quarterpipe, and halfpipe levels.

Swimming permits would follow the traditional YMCA levels of: guppy, minnow, tadpole, fish, flying fish, and shark.

New Meta-Analysis of Effect of Smoking Bans on Heart Attacks Shows Bias in Tobacco Control Research

A new meta-analysis that is in press at Preventive Medicine purports to show that smoking bans result in a 19% immediate decline in heart attack admissions. The meta-analysis pools data from 8 published studies which have examined changes in heart attack admissions following implementation of smoking bans. The study, funded by the National Cancer Institute, concludes that smoking bans result in an immediate reduction in heart attacks, estimating the drop to be 19%, with a 95% confidence interval of 14% to 24% (see: Glantz SA. Meta-analysis of the effects of smokefree laws on acute myocardial infarction: an update. Preventive Medicine 2008 [in press]).

The Rest of the Story

Unfortunately, a meta-analysis is only as good as the studies that go into it. Since the studies used in this meta-analysis have each been discredited, the meta-analysis is not of particular value. A meta-analysis cannot legitimately show that smoking bans dramatically and immediately reduce heart attacks if the individual studies have no validity in drawing such conclusions because they are based on shoddy science.

So it troubles me that tobacco control researchers would even think of conducting a meta-analysis at this early point in time, when we don't even have a single convincing study to suggest that there is a causal relationship between smoking bans and immediate, dramatic reductions in heart attacks.

But more troubling to me is the fact that researchers would include in a meta-analysis (of the effects of smoking bans on heart attacks) studies in which there is no control or comparison group to determine whether observed changes in heart attacks are merely mirroring trends that are occurring everywhere, despite the smoking ban.

If smoking ban opponents produced economic impact studies using the same methodology (showing that there was a decline in restaurant sales or a decrease in the number of restaurants in a particular location, but not employing a control or comparison location), we in tobacco control would trash those studies, pointing out that without a comparison group, one cannot legitimately demonstrate that the smoking ban was what caused the change in restaurant business.

Professor Glantz certainly understands the importance of a comparison group because in his own study (the Helena study), he used a comparison group of non-Helena residents to make sure that the observed changes in heart attacks that occurred in Helena did not also occur outside Helena.

The authors of the studies in Pueblo and Bowling Green also understood the importance of a comparison group because their conclusions were largely based on the finding of a reduction in heart attacks in those cities which did not occur in the comparison areas (El Paso County and Kent, respectively).

Unfortunately, only 3 of the 8 studies used in the meta-analysis employed a comparison group (Helena, Pueblo, and Bowling Green). The other 5 studies did not have a comparison group (Italy x2, Ireland, Saskatoon, and New York State).

There is simply no way that the studies without any comparison group should have been included in this meta-analysis. I don't believe that an objective scientific approach would allow one to use such studies. How can one possibly know that the observed changes in heart attacks were simply a reflection of changes that were taking place everywhere, or at least in similar, neighboring areas?

You can't possibly know that unless you specifically check for it. And 5 of these studies failed to do that.

The more I examine these smoking ban and heart attack studies, the more I am realizing that tobacco control science has become a very highly biased field right now. The bias is so apparent in these studies that it is practically dripping off the pages. Why peer reviewers of the journals do not pick this up is a mystery to me. One possibility, however, is that it is the same set of also-biased tobacco control researchers who are reviewing these articles.

I would be very interested to see how a statistician or econometrician - someone not associated with the tobacco control movement in any way - would review these studies.

Another major problem with the meta-analysis is that it fails to address the very strong possibility of publication bias. It is very likely that tobacco control researchers have only written manuscripts about this issue when they have found or suspected a decline in heart attacks. There has so far been no systematic study of changes in heart attacks in a number of locations to see objectively whether or not this hypothesis is correct. All the studies have been single-site studies.

I myself have examined the heart attack data throughout the U.S. in a systematic way, and based on my review of these data, I was not able to find any evidence that statewide smoking bans led to a dramatic, immediate decline in heart attack admissions. I suspect that if a systematic study were conducted, it would not find any dramatic effect. I think that publication bias is a severe problem in this situation.

The bottom line is that I think it is far too premature to be conducting a meta-analysis in the first place. But if you are going to conduct one, at least have some decent criteria for inclusion of studies.

The rest of this story is not so much about whether smoking bans affect heart attacks or not. It is more about how investigator bias is creeping into tobacco control research these days. And I'm not sure what can be done to stop it.